Patent Publication Number: US-2007100255-A1

Title: Method and apparatus for body fluid sampling and analyte sensing

Description:
BACKGROUND OF THE INVENTION  
      Lancing devices are known in the medical health-care products industry for piercing the skin to produce blood for analysis. Typically, a drop of blood for this type of analysis is obtained by making a small incision in the fingertip, creating a small wound, which generates a small blood droplet on the surface of the skin.  
      Early methods of lancing included piercing or slicing the skin with a needle or razor. Current methods utilize lancing devices that contain a multitude of spring, cam and mass actuators to drive the lancet. These include cantilever springs, diaphragms, coil springs, as well as gravity plumbs used to drive the lancet. The device may be held against the skin and mechanically triggered to ballistically launch the lancet. Unfortunately, the pain associated with each lancing event using known technology discourages patients from testing. In addition to vibratory stimulation of the skin as the driver impacts the end of a launcher stop, known spring based devices have the possibility of firing lancets that harmonically oscillate against the patient tissue, causing multiple strikes due to recoil. This recoil and multiple strikes of the lancet is one major impediment to patient compliance with a structured glucose monitoring regime.  
      Another impediment to patient compliance is the lack of spontaneous blood flow generated by known lancing technology. In addition to the pain as discussed above, a patient may need more than one lancing event to obtain a blood sample since spontaneous blood generation is unreliable using known lancing technology. Thus the pain is multiplied by the number of attempts required by a patient to successfully generate spontaneous blood flow. Different skin thickness may yield different results in terms of pain perception, blood yield and success rate of obtaining blood between different users of the lancing device. Known devices poorly account for these skin thickness variations.  
      A still further impediment to improved compliance with glucose monitoring are the many steps and inconvenience associated with each lancing event. Many diabetic patients that are insulin dependent may need to self-test for blood glucose levels five to six times daily. The large number of steps required in traditional methods of glucose testing, ranging from lancing, to milking of blood, applying blood to a test strip, and getting the measurements from the test strip, discourages many diabetic patients from testing their blood glucose levels as often as recommended. Older patients and those with deteriorating motor skills encounter difficulty loading lancets into launcher devices, transferring blood onto a test strip, or inserting thin test strips into slots on glucose measurement meters. Additionally, the wound channel left on the patient by known systems may also be of a size that discourages those who are active with their hands or who are worried about healing of those wound channels from testing their glucose levels.  
     SUMMARY OF THE INVENTION  
      The present invention provides solutions for at least some of the drawbacks discussed above. Specifically, some embodiments of the present invention provide a multiple lancet solution to measuring analyte levels in the body. The invention may use a high density design. The invention may provide a plurality of analyte detecting members used to sample fluid from tissue. At least some of these and other objectives described herein will be met by embodiments of the present invention.  
      In one aspect of the present invention, a body fluid sampling system is provided for use on a tissue site. In one embodiment, the system comprises a cartridge; a penetrating member driver; a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward; wherein an active one of the penetrating members may be operatively coupled to the penetrating member driver, the penetrating member driver moving the active one along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; and a plurality of analyte detecting members, wherein at least one of the analyte detecting members is positioned to receive fluid from a wound created by the active one of the penetrating members, wherein the detecting members are not pierced by the active one of the penetrating members.  
      In one embodiment of the present invention, a body fluid sampling system for use on a tissue site is provided. The system comprises a cartridge; a penetrating member driver; a plurality of penetrating members, each having a proximal end, an elongate portion, and a sharpened distal end, the members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward; wherein an active one of the penetrating members may be operatively coupled to the penetrating member driver, the penetrating member driver moving the active one along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; and a plurality of analyte detecting members, wherein at least one of the analyte detecting members is positioned to receive fluid from a wound created by the active one of the penetrating members; wherein the unused analyte detecting members are arranged in a stack, the penetrating member driver configured to be controlled to follow a velocity trajectory into the tissue and out of the tissue, wherein the velocity into the tissue is at an average speed greater than an average speed of the penetrating member on the withdrawal.  
      In another embodiment of the present invention, a body fluid sampling system for use on a tissue site is provided. The system comprises a cartridge; a penetrating member driver; a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward; wherein an active one of the penetrating members may be operatively coupled to the penetrating member driver, the penetrating member driver moving the active one along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; and a plurality of analyte detecting members, wherein at least one of the analyte detecting members is positioned to receive fluid from a wound created by the active one of the penetrating members, wherein the detecting members are not pierced by the active one of the penetrating members; a position sensor positioned to provide an indication of a position of the penetrating member during actuation.  
      In yet another embodiment of the present invention, a body fluid sampling system for use on a tissue site is provided. The system comprises a cartridge; a penetrating member driver; a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward; wherein an active one of the penetrating members may be operatively coupled to the penetrating member driver, the penetrating member driver moving the active one along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; and a plurality of analyte detecting members, wherein at least one of the analyte detecting members is positioned to receive fluid from a wound created by the active one of the penetrating members, wherein the detecting members are not pierced by the active one of the penetrating members; a coupler on the penetrating member driver configured to engage at least a portion of the elongate portion of the penetrating member and drive the member along a path into a tissue site and withdrawn from a tissue site.  
      In a still further another embodiment of the present invention, a body fluid sampling system for use on a tissue site is provided. The system comprises a cartridge; a penetrating member driver; a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward; wherein an active one of the penetrating members may be operatively coupled to the penetrating member driver, the penetrating member driver moving the active one along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; and a plurality of analyte detecting members, wherein at least one of the analyte detecting members is positioned to receive fluid from a wound created by the active one of the penetrating members, wherein the detecting members are not pierced by the active one of the penetrating members; a sterility enclosure covering at least a tip of the penetrating member, the sterility enclosure removed from the penetrating member prior to actuation of the member and positioned so that the penetrating member will not contact the enclosure during actuation.  
      In another embodiment of the present invention, a body fluid sampling system for use on a tissue site is provided. The system comprises a cartridge; a penetrating member driver; a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward; wherein an active one of the penetrating members may be operatively coupled to the penetrating member driver, the penetrating member driver moving the active one along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; and a plurality of analyte detecting members, wherein at least one of the analyte detecting members is positioned to receive fluid from a wound created by the active one of the penetrating members, wherein the detecting members are not pierced by the active one of the penetrating members; a user interface for transmitting at least one input between a user.  
      In one aspect, a body fluid sampling device is provided using a penetrating member to extract fluid from an anatomical feature. The device comprises a penetrating member actuator for moving the penetrating member inbound towards the anatomical feature and a non-spring based, penetrating member retractor for moving the penetrating member outbound away from the anatomical feature. The penetrating member actuator may be adapted to move the penetrating member at a velocity greater than a velocity achieved by the penetrating member retractor.  
      In another embodiment of the present invention, a body fluid sampling device is provided for extracting bodily fluid from an anatomical feature. The device comprises a cartridge having a plurality of cavities. The device may also include a plurality of penetrating members, each slidably movable between a first position and a second position to extend outward from the cartridge to penetrate the anatomical feature. The device may further include a penetrating member driver structured to selectively and independently engage the penetrating members, the driver comprising a first resilient member for moving an active one of the penetrating members on an inbound path toward the anatomical feature to create a wound, and a second resilient member for moving the active one of the penetrating members on an outbound path away from the wound.  
      In yet another embodiment, a body fluid sampling device is provided using a penetrating member to extract fluid from an anatomical feature. The device comprises a penetrating member driver, the driver selected from one of the following: a motor and gear box, a nanomuscle, pneumatic device, a liquid magnetic coil actuation device, a stepper motor, a micro-clutch device, and an inductive motor. The device may also include a penetrating coupler attached to the driver, the coupler for releasably connecting the penetrating member to the driver.  
      The system may further comprise means for coupling the force generator with one of the penetrating members.  
      The system may further comprise a penetrating member sensor positioned to monitor a penetrating member coupled to the force generator, the penetrating member sensor configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.  
      The depth of penetration may be about 100 to 2500 microns.  
      The depth of penetration may be about 500 to 750 microns.  
      The depth of penetration may be, in this nonlimiting example, no more than about 1000 microns beyond a stratum corneum thickness of a skin surface.  
      The depth of penetration may be no more than about 500 microns beyond a stratum corneum thickness of a skin surface.  
      The depth of penetration may be no more than about 300 microns beyond a stratum corneum thickness of a skin surface.  
      The depth of penetration may be less than a sum of a stratum corneum thickness of a skin surface and 400 microns.  
      The penetrating member sensor may be further configured to control velocity of a penetrating member.  
      The active penetrating member may move along a substantially linear path into the tissue.  
      The active penetrating member may move along an at least partially curved path into the tissue.  
      The driver may be a voice coil drive force generator.  
      The driver may be a rotary voice coil drive force generator.  
      The penetrating member sensor may be coupled to a processor with control instructions for the penetrating member driver.  
      The processor may include a memory for storage and retrieval of a set of penetrating member profiles utilized with the penetrating member driver.  
      The processor may be utilized to monitor position and speed of a penetrating member as the penetrating member moves in a first direction.  
      The processor may be utilized to adjust an application of force to a penetrating member to achieve a desired speed of the penetrating member.  
      The processor may be utilized to adjust an application of force to a penetrating member when the penetrating member contacts a target tissue so that the penetrating member penetrates the target tissue within a desired range of speed.  
      The processor may be utilized to monitor position and speed of a penetrating member as the penetrating member moves in the first direction toward a target tissue, wherein the application of a launching force to the penetrating member is controlled based on position and speed of the penetrating member.  
      The processor may be utilized to control a withdraw force to the penetrating member so that the penetrating member moves in a second direction away from the target tissue.  
      In the first direction, the penetrating member may move toward the target tissue at a speed that is different than a speed at which the penetrating member moves away from the target tissue.  
      In the first direction the penetrating member may move toward the target tissue at a speed that is greater than a speed at which the penetrating member moves away from the target tissue.  
      The speed of a penetrating member in the first direction may be the range of about 2.0 to 10.0 m/sec.  
      The average velocity of the penetrating member during a tissue penetration stroke in the first direction may be about 100 to about 1000 times greater than the average velocity of the penetrating member during a withdrawal stroke in a second direction.  
      A further understanding of the nature and advantages of the invention will become apparent by reference to the remaining portions of the specification and drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       FIG. 1  is a perspective view illustrating a system, according to an embodiment for use in piercing skin to obtain a blood sample;  
       FIG. 2  is a plan view of a portion of a replaceable penetrating member cartridge forming part of the system;  
       FIG. 3  is a cross-sectional end view on  3 - 3  in  FIG. 2 ;  
       FIG. 4  is a cross-sectional end view on  4 - 4  in  FIG. 2 ;  
       FIG. 5  is a perspective view of an apparatus forming part of the system and used for manipulating components of the cartridge, illustrating pivoting of a penetrating member accelerator in a downward direction;  
       FIG. 6A  is a view similar to  FIG. 5 , illustrating how the cartridge is rotated or advanced;  
       FIG. 6B  is a cross-sectional side view illustrating how the penetrating member accelerator allows for the cartridge to be advanced;  
       FIGS. 7A and 7B  are views similar to  FIGS. 6A and 6B , respectively, illustrating pivoting of the penetrating member accelerator in an opposite direction to engage with a select one of the penetrating members in the cartridge;  
       FIGS. 8A and 8B  are views similar to  FIGS. 7A and 7B , respectively, illustrating how the penetrating member accelerator moves the selected penetrating member to pierce skin;  
       FIGS. 9A and 9B  are views similar to  FIGS. 8A and 8B , respectively, illustrating how the penetrating member accelerator returns the penetrating member to its original position;  
       FIG. 10  is a block diagram illustrating functional components of the apparatus; and  
       FIG. 11  is an end view illustrating a cartridge according to an optional embodiment that allows for better adhesion of sterilization barriers.  
       FIG. 12  is a cross-sectional view of an embodiment having features of the invention.  
       FIG. 13  is a cross-sectional view of an embodiment having features of the invention in operation.  
       FIG. 14  is a cross-sectional view illustrating a low-friction coating applied to one penetrating member contact surface.  
       FIG. 15  is a cross-sectional view illustrating a coating applied to one penetrating member contact surface which increases friction and improves the microscopic contact area between the penetrating member and the penetrating member contact surface.  
       FIG. 16  illustrates a portion of a penetrating member cartridge having an annular configuration with a plurality of radially oriented penetrating member slots and a distal edge of a drive member disposed in one of the penetrating member slots.  
       FIG. 17  is an elevational view in partial longitudinal section of a coated penetrating member in contact with a coated penetrating member contact surface.  
       FIG. 18  illustrates an embodiment of a lancing device having features of the invention.  
       FIG. 19  is a perspective view of a portion of a penetrating member cartridge base plate having a plurality of penetrating member slots and drive member guide slots disposed radially inward of and aligned with the penetrating member slots.  
       FIGS. 20-22  illustrate a penetrating member cartridge in section, a drive member, a penetrating member and the tip of a patient&#39;s finger during three sequential phases of a lancing cycle.  
       FIG. 23  illustrates an embodiment of a penetrating member cartridge having features of the invention.  
       FIG. 24  is an exploded view of a portion of the penetrating member cartridge of  FIG. 12 .  
       FIGS. 25 and 26  illustrate a multiple layer sterility barrier disposed over a penetrating member slot being penetrated by the distal end of a penetrating member during a lancing cycle.  
       FIGS. 27 and 28  illustrate an embodiment of a drive member coupled to a driver wherein the drive member includes a cutting member having a sharpened edge which is configured to cut through a sterility barrier of a penetrating member slot during a lancing cycle in order for the drive member to make contact with the penetrating member.  
       FIGS. 29 and 30  illustrate an embodiment of a penetrating member slot in longitudinal section having a ramped portion disposed at a distal end of the penetrating member slot and a drive member with a cutting edge at a distal end thereof for cutting through a sterility barrier during a lancing cycle.  
       FIGS. 31-34  illustrate drive member slots in a penetrating member cartridge wherein at least a portion of the drive member slots have a tapered opening which is larger in transverse dimension at the top of the drive member slot than at the bottom of the drive member slot.  
       FIGS. 35-37  illustrate an embodiment of a penetrating member cartridge and penetrating member drive member wherein the penetrating member drive member has a contoured jaws configured to grip a penetrating member shaft.  
       FIGS. 38 and 39  show a portion of a lancing device having a lid that can be opened to expose a penetrating member cartridge cavity for removal of a used penetrating member cartridge and insertion of a new penetrating member cartridge.  
       FIGS. 40 and 41  illustrate a penetrating member cartridge that has penetrating member slots on both sides.  
       FIGS. 42-44  illustrate end and perspective views of a penetrating member cartridge having a plurality of penetrating member slots formed from a corrugated surface of the penetrating member cartridge.  
       FIGS. 45-48  illustrate embodiments of a penetrating member and drive member wherein the penetrating member has a slotted shaft and the drive member has a protuberance configured to mate with the slot in the penetrating member shaft.  
       FIG. 49  is a perspective view of a cartridge according to the present invention.  
       FIGS. 50 and 51  show close-ups of outer peripheries various cartridges.  
       FIG. 52  is a perspective view of an underside of a cartridge.  
       FIG. 53A  shows a top down view of a cartridge and the punch and pusher devices.  
       FIG. 53B  is a perspective view of one embodiment of a punch plate.  
       FIGS. 54A-54G  show a sequence of motion for the punch plate, the cartridge, and the cartridge pusher.  
       FIGS. 55A-55B  show cross-sections of the system according to the present invention.  
       FIG. 56A  shows a perspective view of the system according to the present invention.  
       FIGS. 56B-56D  are cut-away views showing mechanisms within the present invention.  
       FIGS. 57-65B  show optional embodiments according to the present invention.  
       FIG. 66-68  shows a still further embodiment of a cartridge according to the present invention.  
       FIGS. 69A-69L  show the sequence of motions associated with an optional embodiment of a cartridge according to the present invention.  
       FIG. 70-72  show views of a sample modules used with still further embodiments of a cartridge according to the present invention.  
       FIG. 73  shows a cartridge with a sterility barrier and an analyte detecting member layer.  
       FIG. 74-78  show still further embodiments of analyte detecting members coupled to a cartridge.  
       FIGS. 79-84  show optional configurations for a cartridge for use with the present invention.  
       FIG. 85  shows a see-through view of one embodiment of a system according to the present invention.  
       FIG. 86  is a schematic of an optional embodiment of a system according to the present invention.  
       FIGS. 87A-87B  show still further embodiments of cartridges according to the present invention.  
       FIG. 88  shows a cartridge having an array of analyte detecting members.  
       FIGS. 89-90  show embodiments of illumination systems for use with the present invention.  
       FIGS. 91-96  show further embodiments using optical methods for analyte detection.  
       FIG. 97  shows a chart of varying penetrating member velocity in different parts of the tissue.  
       FIGS. 98 and 99  show schematic views of penetrating member drivers according to the present invention.  
       FIG. 100  shows a penetrating member driver according to the present invention for use with a cartridge containing a plurality of penetrating members.  
       FIGS. 101 and 102  show a penetrating member driver using a magnetically controllable fluid device.  
       FIGS. 103-104  show embodiments of an improved penetrating member.  
       FIGS. 105-109  shows a penetrating member driver using a spring and a non-spring based retractor device.  
       FIG. 110  shows an embodiment of a damper according to the present invention.  
       FIGS. 111-116  shows a cartridge and a penetrating member driver according to the present invention.  
       FIGS. 117 and 118  show penetrating member drivers according to the present invention.  
       FIGS. 119-120  show a depth setting device according to the present invention.  
       FIG. 121  shows a cam groove according to the present invention.  
       FIGS. 122-124  show various penetrating member devices according to the present invention.  
       FIGS. 125A-125B  show kits according to the present invention.  
       FIGS. 126-129  show embodiments of the present invention according to the present invention using a test strip.  
       FIG. 130  shows one embodiment of a cartridge according to the present invention.  
       FIGS. 131 and 132  shows a top down view and side view of another embodiment according to the present invention.  
       FIGS. 133 and 135  show a still further embodiment of a cartridge according to the present invention.  
       FIG. 136  shows a penetrating member device used with a stack of analyte detecting members.  
       FIG. 137  shows one embodiment of a voice coil based actuator.  
       FIG. 138  shows another embodiment of a voice coil based actuator.  
       FIG. 139  shows another embodiment of a voice coil based actuator.  
       FIG. 140  shows an embodiment of a voice coil based actuator with a shaped core.  
       FIG. 141  illustrates a displacement over time profile of a penetrating member driven by a harmonic spring/mass system.  
       FIG. 142  illustrates the velocity over time profile of a penetrating member driver by a harmonic spring/mass system.  
       FIG. 143  illustrates a displacement over time profile of an embodiment of a controllable force driver.  
       FIG. 144  illustrates a velocity over time profile of an embodiment of a controllable force driver.  
       FIG. 145  is a graph of force vs. time during the advancement and retraction of a penetrating member showing some characteristic phases of a lancing cycle.  
       FIG. 146  is a graph showing displacement of a penetrating member over time.  
       FIG. 147  is a graph showing an embodiment of a velocity profile, which includes the velocity of a penetrating member over time including reduced velocity during retraction of the penetrating member.  
       FIG. 148  is a graphical representation of position and velocity vs. time for a lancing cycle.  
       FIG. 149  illustrates a sectional view of the layers of skin with a penetrating member disposed therein.  
       FIG. 150  is a graphical representation of velocity vs. position of a lancing cycle.  
       FIG. 151  is a graphical representation of velocity vs. time of a lancing cycle. 
    
    
     DESCRIPTION OF THE SPECIFIC EMBODIMENTS  
      The present invention provides a multiple analyte detecting member solution for body fluid sampling. Specifically, some embodiments of the present invention provides a multiple analyte detecting member and multiple penetrating member solution to measuring analyte levels in the body. The invention may use a high density design. It may use penetrating members of smaller size, such as but not limited to diameter or length, than known lancets. The device may be used for multiple lancing events without having to remove a disposable from the device. The invention may provide improved sensing capabilities. At least some of these and other objectives described herein will be met by embodiments of the present invention.  
      It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. It must be noted that, as used in the specification and the appended claims, the singular forms “a”, “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a material” may include mixtures of materials, reference to “a chamber” may include multiple chambers, and the like. References cited herein are hereby incorporated by reference in their entirety, except to the extent that they conflict with teachings explicitly set forth in this specification.  
      In this specification and in the claims which follow, reference will be made to a number of terms which shall be defined to have the following meanings:  
      “Optional” or “optionally” means that the subsequently described circumstance may or may not occur, so that the description includes instances where the circumstance occurs and instances where it does not. For example, if a device optionally contains a feature for analyzing a blood sample, this means that the analysis feature may or may not be present, and, thus, the description includes structures wherein a device possesses the analysis feature and structures wherein the analysis feature is not present.  
      “Analyte detecting member” refers to any use, singly or in combination, of chemical test reagents and methods, electrical test circuits and methods, physical test components and methods, optical test components and methods, and biological test reagents and methods to yield information about a blood sample. Such methods are well known in the art and may be based on teachings of, e.g. Tietz Textbook of Clinical Chemistry, 3d Ed., Sec. V, pp. 776-78 (Burtis &amp; Ashwood, Eds., W.B. Saunders Company, Philadelphia, 1999); U.S. Pat. No. 5,997,817 to Chrismore et al. (Dec. 7, 1999); U.S. Pat. No. 5,059,394 to Phillips et al. (Oct. 22, 1991); U.S. Pat. No. 5,001,054 to Wagner et al. (Mar. 19, 1991); and U.S. Pat. No. 4,392,933 to Nakamura et al. (Jul. 12, 1983), the teachings of which are hereby incorporated by reference, as well as others. Analyte detecting member may include tests in the sample test chamber that test electrochemical properties of the blood, or they may include optical means for sensing optical properties of the blood (e.g. oxygen saturation level), or they may include biochemical reagents (e.g. antibodies) to sense properties (e.g. presence of antigens) of the blood. The analyte detecting member may comprise biosensing or reagent material that will react with an analyte in blood (e.g. glucose) or other body fluid so that an appropriate signal correlating with the presence of the analyte is generated and can be read by the reader apparatus. By way of example and not limitation, analyte detecting member may be “associated with”, “mounted within”, or “coupled to” a chamber or other structure when the analyte detecting member participates in the function of providing an appropriate signal about the blood sample to the reader device. Analyte detecting member may also include nanowire analyte detecting members as described herein. Analyte detecting member may use any, singly or in combination, potentiometric, coulometric, or other method useful for detection of analyte levels.  
       FIGS. 1-11  of the accompanying drawings illustrates one embodiment of a system  10  for piercing tissue to obtain a blood sample. The system  10  may include a replaceable cartridge  12  and an apparatus  14  for removably receiving the cartridge  12  and for manipulating components of the cartridge  12 .  
      Referring jointly to  FIGS. 1 and 2 , the cartridge  12  may include a plurality of penetrating members  18 . The cartridge  12  may be in the form of a circular disc and has an outer circular surface  20  and an opening forming an inner circular surface  22 . A plurality of grooves  24  are formed in a planar surface  26  of the cartridge  12 . Each groove  24  is elongated and extends radially out from a center point of the cartridge  12 . Each groove  24  is formed through the outer circular surface  20 . Although not shown, it should be understood that the grooves  24  are formed over the entire circumference of the planar surface  26 . As shown in  FIGS. 3 and 4 , each groove  24  is relatively narrow closer to the center point of the cartridge  12  and slightly wider further from the center point. These grooves  24  may be molded into the cartridge  12 , machined into the cartridge, forged, pressed, or formed using other methods useful in the manufacture of medical devices.  
      In the present embodiment, each penetrating member  18  has an elongated body  26  and a sharpened distal end  27  having a sharp tip  30 . The penetrating member  18  may have a circular cross-section with a diameter in this embodiment of about 0.315 mm. All outer surfaces of the penetrating member  18  may have the same coefficient of friction. The penetrating member may be, but is not necessarily, a bare lancet. The lancet is “bare”, in the sense that no raised formations or molded parts are formed thereon that are complementarily engageable with another structure. Traditional lancets include large plastic molded parts that are used to facilitate engagement. Unfortunately, such attachments add size and cost. In the most basic sense, a bare lancet or bare penetrating member is an elongate wire having sharpened end. If it is of sufficiently small diameter, the tip may be penetrating without having to be sharpened. A bare lancet may be bent and still be considered a bare lancet. The bare lancet in one embodiment may be made of one material.  
      In the present embodiment, each penetrating member  18  is located in a respective one of the grooves  24 . The penetrating members  18  have their sharpened distal ends  27  pointed radially out from the center point of the cartridge  12 . A proximal end of each penetrating member  15  may engage in an interference fit with opposing sides of a respective groove  24  as shown in  FIG. 3 . Other embodiments of the cartridge  12  may not use such an interference fit. As a nonlimiting example, they may use a fracturable adhesive to releasably secure the penetrating member  18  to the cartridge  12 . As shown in  FIG. 4 , more distal portions of the penetrating member  18  are not engaged with the opposing sides of the groove  24  due to the larger spacing between the sides.  
      The cartridge  12  may further include a sterilization barrier  28  attached to the upper surface  26 . The sterilization barrier  28  is located over the penetrating members  18  and serves to insulate the penetrating members  18  from external contaminants. The sterilization barrier  28  is made of a material that can easily be broken when an edge of a device applies a force thereto. The sterilization barrier  28  alone or in combination with other barriers may be used to create a sterile environment about at least the tip of the penetrating member prior to lancing or actuation. The sterilization barrier  28  may be made of a variety of materials such as but not limited to metallic foil, aluminum foil, paper, polymeric material, or laminates combining any of the above. Other details of the sterilization barrier are detailed herein.  
      In the present embodiment, the apparatus  14  may include a housing  30 , an initiator button  32 , a penetrating member movement subassembly  34 , a cartridge advance subassembly  36 , batteries  38 , a capacitor  40 , a microprocessor controller  42 , and switches  44 . The housing  30  may have a lower portion  46  and a lid  48 . The lid  48  is secured to the lower portion  46  with a hinge  50 . The lower portion  46  may have a recess  52 . A circular opening  54  in the lower portion  46  defines an outer boundary of the recess  52  and a level platform  56  of the lower portion  46  defines a base of the recess  52 .  
      In use, the lid  48  of the present embodiment is pivoted into a position as shown in  FIG. 1 . The cartridge  12  is flipped over and positioned in the recess  52 . The planar surface  26  rests against the level platform  56  and the circular opening  54  contacts the outer circular surface  20  to prevent movement of the cartridge  12  in a plane thereof. The lid  48  is then pivoted in a direction  60  and closes the cartridge  12 .  
      Referring to the embodiment shown in  FIG. 5 , the penetrating member movement subassembly  34  includes a lever  62 , a penetrating member accelerator  64 , a linear actuator  66 , and a spring  68 . Other suitable actuators including but not limited to rotary actuators are described in commonly assigned, copending U.S. patent application Ser. No. 10/127,395 (Attorney Docket No. 38187-2551) filed Apr. 19, 2002. The lever  62  may be pivotably secured to the lower portion  46 . The button  32  is located in an accessible position external of the lower portion  46  and is connected by a shaft  70  through the lower portion  46  to one end of the lever  62 . The penetrating member accelerator  64  is mounted to an opposing end of the lever  62 . A user depresses the button  32  in an upward direction  66  so that the shaft  70  pivots the end of the lever  62  to which it is connected in an upward direction. The opposing end of the lever pivots in a downward direction  66 . The spring  46  is positioned between the button  32  and the base  40  and compresses when the button  32  is depressed to create a force that tends to move the button  32  down and pivot the penetrating member accelerator upward in a direction opposite to the direction  64 .  
      Referring to  FIGS. 6A and 6B  in this particular embodiment, the movement of the button into the position shown in  FIG. 5  also causes contact between a terminal  74  on the shaft  20  with a terminal  70  secured to the lower portion  46 . Contact between the terminals  74  and  76  indicates that the button  32  has been fully depressed. With the button  32  depressed, the cartridge  12  can be rotated without interference by the penetrating member actuator  64 . To this effect, the cartridge advancer subsystem  36  includes a pinion gear  80  and a stepper motor  82 . The stepper motor  82  is secured to the lower portion  46 . The pinion gear  80  is secured to the stepper motor  82  and is rotated by the stepper motor  82 . Teeth on the pinion gear  80  engage with teeth on the inner circular surface  22  of the cartridge  12 . Rotation of the pinion gear  80  causes rotation of the cartridge  12  about the center point thereof. Each time that the terminals  74  and  76  make contact, the stepper motor  82  is operated to rotate the cartridge  12  through a discrete angle equal to an angular spacing from a centerline of one of the penetrating members  18  to a centerline of an adjacent penetrating member. A select penetrating member  18  is so moved over the penetrating member accelerator  64 , as shown in  FIG. 6B . Subsequent depressions of the button  32  will cause rotation of subsequent adjacent penetrating members  18  into a position over the penetrating member accelerator  64 .  
      The user then releases pressure from the button, as shown in  FIG. 7A . The force created by the spring  68  or other resilient member moves the button  32  in a downward direction  76 . The shaft  70  is pivotably secured to the lever  62  so that the shaft  70  moves the end of the lever  62  to which it is connected down. The opposite end of the lever  62  pivots the penetrating member accelerator  64  upward in a direction  80 . As shown in  FIG. 7B , an edge  82  of the penetrating member accelerator  64  breaks through a portion of the sterilization barrier  28  and comes in to physical contact with a lower side surface of the penetrating member  18 .  
      Referring to  FIG. 8A , the linear actuator  66  includes separate advancing coils  86 A and retracting coils  86 B, and a magnetizable slug  90  within the coils  86 A and  86 B. The coils  86 A and  86 B are secured to the lower portion of  46 , and the slug  90  can move within the coils  86 A and  88 B. Once the penetrating member accelerator  64  is located in the position shown in  FIGS. 7A and 7B , electric current is provided to the advancing coils  86  only. The current in the advancing coils  86  creates a force in a direction  88  on the slug  90  according to conventional principles relating to electromagnetics.  
      A bearing  91  is secured to the lever and the penetrating member accelerator  64  has a slot  92  over the bearing  91 . The slot  92  allows for the movement of the penetrating member accelerator  64  in the direction  88  relative to the lever  62 , so that the force created on the slug moves the penetrating member accelerator  64  in the direction  88 .  
      The spring  68  is not entirely relaxed, so that the spring  68 , through the lever  62 , biases the penetrating member accelerator  64  against the lower side surface of the penetrating member  18  with a force F 1 . The penetrating member  18  rests against a base  88  of the cartridge  12 . An equal and opposing force F 2  is created by the base  88  on an upper side surface of the penetrating member  18 .  
      The edge  82  of the penetrating member accelerator  64  has a much higher coefficient of friction than the base  88  of the cartridge  12 . The higher coefficient of friction of the edge contributes to a relatively high friction force F 3  on the lower side surface of the penetrating member  18 . The relatively low coefficient of friction of the base  88  creates a relatively small friction force F 4  on the upper side surface of the penetrating member  18 . A difference between the force F 3  and F 4  is a resultant force that accelerates the penetrating member in the direction  88  relative to the cartridge  12 . The penetrating member is moved out of the interference fit illustrated in  FIG. 3 . The bare penetrating member  18  is moved without the need for any engagement formations on the penetrating member. Current devices, in contrast, often make use a plastic body molded onto each penetrating member to aid in manipulating the penetrating members. Movement of the penetrating member  18  moves the sharpened end thereof through an opening  90  in a side of the lower portion  46 . The sharp end  30  of the penetrating member  18  is thereby moved from a retracted and safe position within the lower portion  46  into a position wherein it extends out of the opening  90 . Accelerated, high-speed movement of the penetrating member is used so that the sharp tip  30  penetrates skin of a person. A blood sample can then be taken from the person, typically for diabetic analysis.  
      Reference is now made to  FIGS. 9A and 9B . After the penetrating member is accelerated (for example, but not limitation, less than 0.25 seconds thereafter), the current to the accelerating coils  86 A is turned off and the current is provided to the retracting coils  86 B. The slug  90  moves in an opposite direction  92  together with the penetrating member accelerator  64 . The penetrating member accelerator  64  then returns the used penetrating member into its original position, i.e., the same as shown in  FIG. 7B .  
      Subsequent depression of the button as shown in  FIG. 5  will then cause one repetition of the process described, but with an adjacent sterile penetrating member. Subsequent sterile penetrating members can so be used until all the penetrating members have been used, i.e., after one complete revolution of the cartridge  12 . In this embodiment, a second revolution of the cartridge  12  is disallowed to prevent the use of penetrating members that have been used in a previous revolution and have become contaminated. The only way in which the user can continue to use the apparatus  14  is by opening the ‘lid  48  as shown in  FIG. 1 , removing the used cartridge  12 , and replacing the used cartridge with another cartridge. A detector (not shown) detects whenever a cartridge is removed and replaced with another cartridge. Such a detector may be but is not limited to an optical sensor, an electrical contact sensor, a bar code reader, or the like.  
       FIG. 10  illustrates the manner in which the electrical components may be functionally interconnected for the present embodiment. The battery  38  provides power to the capacitor  40  and the controller  42 . The terminal  76  is connected to the controller  42  so that the controller recognizes when the button  32  is depressed. The capacitor to provide power (electric potential and current) individually through the switches (such as field-effect transistors) to the advancing coils  86 A, retracting coils  86 B and the stepper motor  82 . The switches  44 A, B, and C are all under the control of the controller  42 . A memory  100  is connected to the controller. A set of instructions is stored in the memory  100  and is readable by the controller  42 . Further functioning of the controller  42  in combination with the terminal  76  and the switches  44 A, B, and C should be evident from the foregoing description.  
       FIG. 11  illustrates a configuration for another embodiment of a cartridge having penetrating members. The cartridge  112  has a corrugated configuration and a plurality of penetrating members  118  in grooves  124  formed in opposing sides of the cartridge  112 . Sterilization barriers  126  and  128  are attached over the penetrating members  118  at the top and the penetrating members  118  at the bottom, respectively. Such an arrangement provides large surfaces for attachment of the sterilization barriers  126  and  128 . All the penetrating members  118  on the one side are used first, whereafter the cartridge  112  is turned over and the penetrating members  118  on the other side are used. Additional aspects of such a cartridge are also discussed in  FIGS. 42-44 .  
      Referring now to  FIGS. 12-13 , a friction based method of coupling with and driving bare lancets or bare penetrating members will be described in further detail. Any embodiment of the present invention disclosed herein may be adapted to use these methods. As seen in  FIG. 12 , surface  201  is physically in contact with penetrating member  202 . Surface  203  is also physically in contact with penetrating member  202 . In the present embodiment of the invention, surface  201  is stainless steel, penetrating member  202  is stainless steel, and surface  203  is polytetrafluoroethylene-coated stainless steel.  
       FIG. 13  illustrates one embodiment of the friction based coupling in use. Normal force  206  may be applied vertically to surface  201 , pressing it against penetrating member  202 . Penetrating member  202  is thereby pressed against surface  203 . Normal force  206  is transmitted through surface  201  and penetrating member  202  to also act between penetrating member  202  and surface  203 . Surface  203  is held rigid or stationary with respect to a target of the lancet. Using the classical static friction model, the maximum frictional force between surface  201  and penetrating member  202  is equal to the friction coefficient between surface  201  and penetrating member  202  multiplied by the normal force between surface  201  and penetrating member  202 . In this embodiment, the maximum frictional force between surface  203  and penetrating member  202  is equal to the coefficient of friction between the surface  203  and the penetrating member  202  multiplied by the normal force between the surface  203  and the penetrating member  202 . Because friction coefficient between surface  203  and penetrating member  202  is less than friction coefficient between surface  201  and penetrating member  202 , the interface between surface  201  and penetrating member  202  can develop a higher maximum static friction force than can the interface between surface  203  and penetrating member  202 .  
      Driving force as indicated by arrow  207  is applied to surface  201  perpendicular to normal force  206 . The sum of the forces acting horizontally on surface  201  is the sum of driving force  207  and the friction force developed at the interface of surface  201  and penetrating member  202 , which acts in opposition to driving force  207 . Since the coefficient of friction between surface  203  and penetrating member  202  is less than the coefficient of friction between surface  201  and penetrating member  202 , penetrating member  202  and surface  201  will remain stationary with respect to each other and can be considered to behave as one piece when driving force  207  just exceeds the maximum frictional force that can be supported by the interface between surface  203  and penetrating member  202 . Surface  201  and penetrating member  202  can be considered one piece because the coefficient of friction between surface  201  and penetrating member  202  is high enough to prevent relative motion between the two.  
      In one embodiment, the coefficient of friction between surface  201  and penetrating member  202  is approximately 0.8 corresponding to the coefficient of friction between two surfaces of stainless steel, while the coefficient of friction between surface  203  and penetrating member  202  is approximately 0.04, corresponding to the coefficient of friction between a surface of stainless steel and one of polytetrafluoroethylene. Normal force  206  has a value of 202 Newtons. Using these values, the maximum frictional force that the interface between surface  201  and penetrating member  202  can support is 1.6 Newtons, while the maximum frictional force that the interface between surface  203  and penetrating member  202  can support is 0.08 Newtons. If driving force  207  exceeds 0.08 Newtons, surface  201  and penetrating member  202  will begin to accelerate together with respect to surface  203 . Likewise, if driving force  207  exceeds 1.6 Newtons and penetrating member  202  encounters a rigid barrier, surface  201  would move relative to penetrating member  202 .  
      Another condition, for example, for surface  201  to move relative to penetrating member  202  would be in the case of extreme acceleration. In an embodiment, penetrating member  202  has a mass of 8.24×10−6 kg. An acceleration of 194,174 m/s2 of penetrating member  202  would therefore be required to exceed the frictional force between penetrating member  202  and surface  201 , corresponding to approximately 19,800 g&#39;s. Without being bound to any particular embodiment or theory of operation, other methods of applying friction base coupling may also be used. For example, the penetrating member  202  may be engaged by a coupler using a interference fit to create the frictional engagement with the member.  
       FIG. 14  illustrates a polytetrafluoroethylene coating on stainless steel surface  203  in detail. It should be understood that the surface  203  may be coated with other materials such as but not limited to Telfon®, silicon, polymer or glass. The coating may cover all of the penetrating member, only the proximal portions, only the distal portions, only the tip, only some other portion, or some combination of some or all of the above.  FIG. 15  illustrates a doping of lead applied to surface  201 , which conforms to penetrating member  202  microscopically when pressed against it. Both of these embodiments and other coated embodiments of a penetrating member may be used with the actuation methods described herein.  
      The shapes and configurations of surface  201  and surface  102  could be some form other than shown in  FIGS. 12-15 . For example, surface  201  could be the surface of a wheel, which when rotated causes penetrating member  202  to advance or retract relative to surface  203 . Surface  201  could be coated with another conformable material besides lead, such as a plastic. It could also be coated with particles, such as diamond dust, or given a surface texture to enhance the friction coefficient of surface  201  with penetrating member  202 . Surface  202  could be made of or coated with diamond, fluorinated ethylene propylene, perfluoroalkoxy, a copolymer of ethylene and tetrafluoroethylene, a copolymer of ethylene and chlorotrifluoroethylene, or any other material with a coefficient of friction with penetrating member  202  lower than that of the material used for surface  201 .  
      Referring to  FIG. 16 , a portion of a base plate  210  of an embodiment of a penetrating member cartridge is shown with a plurality of penetrating member slots  212  disposed in a radial direction cut into a top surface  214  of the base plate. A drive member  216  is shown with a distal edge  218  disposed within one of the penetrating member slots  212  of the base plate  210 . The distal edge  218  of the drive member  216  is configured to slide within the penetrating member slots  212  with a minimum of friction but with a close fit to minimize lateral movement during a lancing cycle.  
       FIG. 17  shows a distal portion  220  of a coated penetrating member  222  in partial longitudinal section. The coated penetrating member  222  has a core portion  224 , a coating  226  and a tapered distal end portion  228 . A portion of a coated drive member  230  is shown having a coating  234  with penetrating member contact surface  236 . The penetrating member contact surface  236  forms an interface  238  with an outer surface  240  of the coated penetrating member  222 . The interface  238  has a characteristic friction coefficient that will depend in part on the choice of materials for the penetrating member coating  226  and the drive member coating  234 . If silver is used as the penetrating member and drive member coating  226  and  236 , this yields a friction coefficient of about 1.3 to about 1.5. Other materials can be used for coatings  226  and  236  to achieve the desired friction coefficient. For example, gold, platinum, stainless steel and other materials may be used for coatings  226  and  236 . It may be desirable to use combinations of different materials for coatings  226  and  236 . For example, an embodiment may include silver for a penetrating member coating  226  and gold for a drive member coating. Some embodiments of the interface  238  can have friction coefficients of about 1.15 to about 5.0, specifically, about 1.3 to about 2.0.  
      Embodiments of the penetrating member  222  can have an outer transverse dimension or diameter of about 200 to about 400 microns, specifically, about 275 to about 325 microns. Embodiments of penetrating member  222  can have a length of about 10 to about 30 millimeters, specifically, about 15 to about 25 millimeters. Penetrating member  222  can be made from any suitable high strength alloy such as stainless steel or the like.  
       FIG. 18  is a perspective view of a lancing device  242  having features of the invention. A penetrating member cartridge  244  is disposed about a driver  246  that is coupled to a drive member  248  by a coupler rod  250 . The penetrating member cartridge  244  has a plurality of penetrating member slots  252  disposed in a radial configuration in a top surface  254  a base plate  256  of the penetrating member cartridge  244 . The distal ends  253  of the penetrating member slots  252  are disposed at an outer surface  260  of the base plate  256 . A fracturable sterility barrier  258 , shown partially cut away, is disposed on the top surface  254  of base plate  256  over the plurality of penetrating member slots  252 . The sterility barrier  258  is also disposed over the outer surface  260  of the base plate  256  in order to seal the penetrating member slots from contamination prior to a lancing cycle. A distal portion of a penetrating member  262  is shown extending radially from the penetrating member cartridge  244  in the direction of a patient&#39;s finger  264 .  
       FIG. 19  illustrates a portion of the base plate  256  used with the lancing device  242  in more detail and without sterility barrier  258  in place (for ease of illustration). The base plate  256  includes a plurality of penetrating member slots  252  which are in radial alignment with corresponding drive member slots  266 . The drive member slots  266  have an optional tapered input configuration that may facilitate alignment of the drive member  248  during downward movement into the drive member slot  266  and penetrating member slot  252 . Penetrating member slots  252  are sized and configured to accept a penetrating member  262  disposed therein and allow axial movement of the penetrating member  262  within the penetrating member slots  252  without substantial lateral movement.  
      Referring again to  FIG. 18 , in use, the present embodiment of penetrating member cartridge  242  is placed in an operational configuration with the driver  246 . A lancing cycle is initiated and the drive member  248  is brought down through the sterility barrier  258  and into a penetrating member slot  252 . A penetrating member contact surface of the drive member then makes contact with an outside surface of the penetrating member  262  and is driven distally toward the patient&#39;s finger  264  as described above with regard to the embodiment discussed in  FIG. 20 . The friction coefficient between the penetrating member contact surface of the drive member  248  and the penetrating member  262  is greater than the friction coefficient between the penetrating member  262  and an interior surface of the penetrating member slots  252 . As such, the drive member  248  is able to drive the penetrating member  262  distally through the sterility barrier  258  and into the patient&#39;s finger  264  without any relative movement or substantial relative movement between the drive member  248  and the penetrating member  262 .  
      Referring to  FIGS. 20-22 , a lancing cycle sequence is shown for a lancing device  242  with another embodiment of a penetrating member cartridge  244  as shown in  FIGS. 23 and 24 . The base plate  256  of the penetrating member cartridge  242  shown in  FIGS. 23 and 24  has a plurality of penetrating member slots  252  with top openings  268  that do not extend radially to the outer surface  260  of the base plate  256 . In this way, the penetrating member slots  252  can be sealed with a first sterility barrier  270  disposed on the top surface  254  of the base plate  256  and a second sterility barrier  272  disposed on the outer surface  260  of the base plate  256 . Penetrating member outlet ports  274  are disposed at the distal ends of the penetrating member slots  252 .  
      Referring again to  FIG. 20 , the penetrating member  262  is shown in the proximally retracted starting position within the penetrating member slot  252 . The outer surface of the penetrating member  276  is in contact with the penetrating member contact surface  278  of the drive member  248 . The friction coefficient between the penetrating member contact surface  278  of the drive member  248  and the outer surface  276  of the penetrating member  262  is greater than the friction coefficient between the penetrating member  262  and an interior surface  280  of the penetrating member slots  252 . A distal drive force as indicated by arrow  282  in  FIG. 10  is then applied via the drive coupler  250  to the drive member  248  and the penetrating member is driven out of the penetrating member outlet port  274  and into the patient&#39;s finger  264 . A proximal retraction force, as indicated by arrow  284  in  FIG. 22 , is then applied to the drive member  248  and the penetrating member  262  is withdrawn from the patient&#39;s finger  264  and back into the penetrating member slot  252 .  
       FIGS. 25 and 26  illustrate an embodiment of a multiple layer sterility barrier  258  in the process of being penetrated by a penetrating member  62 . It should be understood that this barrier  258  may be adapted for use with any embodiment of the present invention. The sterility barrier  258  shown in  FIGS. 25 and 26  is a two layer sterility barrier  258  that facilitates maintaining sterility of the penetrating member  262  as it passes through and exits the sterility barrier  258 . In  FIG. 25 , the distal end  286  of the penetrating member  262  is applying an axial force in a distal direction against an inside surface  288  of a first layer  290  of the sterility barrier  258 , so as to deform the first layer  290  of the sterility barrier  258 . The deformation  291  of the first layer  290  in turn applies a distorting force to the second layer  292  of the sterility barrier  258 . The second layer of the sterility barrier is configured to have a lower tensile strength that the first layer  290 . As such, the second layer  292  fails prior to the first layer  290  due to the strain imposed on the first layer  290  by the distal end  286  of the penetrating member  262 , as shown in  FIG. 26 . After the second layer  292  fails, it then retracts from the deformed portion  291  of the first layer  290  as shown by arrows  294  in  FIG. 26 . As long as the inside surface  288  and outside surface  296  of the first layer  290  are sterile prior to failure of the second layer  292 , the penetrating member  262  will remain sterile as it passes through the first layer  290  once the first layer eventually fails. Such a multiple layer sterility barrier  258  can be used for any of the embodiments discussed herein. The multiple layer sterility barrier  258  can also include three or more layers.  
      Referring to  FIGS. 27 and 28 , an embodiment of a drive member  300  coupled to a driver  302  wherein the drive member  300  includes a cutting member  304  having a sharpened edge  306  which is configured to cut through a sterility barrier  258  of a penetrating member slot  252  during a lancing cycle in order for the drive member  300  to make contact with a penetrating member. An optional lock pin  308  on the cutting member  304  can be configured to engage the top surface  310  of the base plate in order to prevent distal movement of the cutting member  304  with the drive member  300  during a lancing cycle.  
       FIGS. 29 and 30  illustrate an embodiment of a penetrating member slot  316  in longitudinal section having a ramped portion  318  disposed at a distal end  320  of the penetrating member slot. A drive member  322  is shown partially disposed within the penetrating member slot  316 . The drive member  322  has a cutting edge  324  at a distal end  326  thereof for cutting through a sterility barrier  328  during a lancing cycle.  FIG. 30  illustrates the cutting edge  324  cutting through the sterility barrier  328  during a lancing cycle with the cut sterility barrier  328  peeling away from the cutting edge  324 .  
       FIGS. 31-34  illustrate drive member slots in a base plate  330  of a penetrating member cartridge wherein at least a portion of the drive member slots have a tapered opening which is larger in transverse dimension at a top surface of the base plate than at the bottom of the drive member slot.  FIG. 31  illustrates a base plate  330  with a penetrating member slot  332  that is tapered at the input  334  at the top surface  336  of the base plate  330  along the entire length of the penetrating member slot  332 . In such a configuration, the penetrating member slot and drive member slot (not shown) would be in communication and continuous along the entire length of the slot  332 . As an optional alternative, a base plate  338  as shown in  FIGS. 32 and 33  can have a drive member slot  340  that is axially separated from the corresponding penetrating member slot  342 . With this configuration, the drive member slot  340  can have a tapered configuration and the penetrating member slot  342  can have a straight walled configuration. In addition, this configuration can be used for corrugated embodiments of base plates  346  as shown in  FIG. 34 . In  FIG. 34 , a drive member  348  is disposed within a drive member slot  350 . A penetrating member contact surface  352  is disposed on the drive member  348 . The contact surface  352  has a tapered configuration that will facilitate lateral alignment of the drive member  348  with the drive member slot  350 .  
       FIGS. 35-37  illustrate an embodiment of a penetrating member cartridge  360  and drive member  362  wherein the drive member  362  has contoured jaws  364  configured to grip a penetrating member shaft  366 . In  FIG. 35 , the drive member  362  and penetrating member shaft  366  are shown in transverse cross section with the contoured jaws  364  disposed about the penetrating member shaft  366 . A pivot point  368  is disposed between the contoured jaws  364  and a tapered compression slot  370  in the drive member  362 . A compression wedge  372  is shown disposed within the tapered compression slot  370 . Insertion of the compression wedge  372  into the compression slot  370  as indicated by arrow  374 , forces the contoured jaws  364  to close about and grip the penetrating member shaft  366  as indicated by arrows  376 .  
       FIG. 36  shows the drive member  362  in position about a penetrating member shaft  366  in a penetrating member slot  378  in the penetrating member cartridge  360 . The drive member can be actuated by the methods discussed above with regard to other drive member and driver embodiments.  FIG. 37  is an elevational view in longitudinal section of the penetrating member shaft  166  disposed within the penetrating member slot  378 . The arrows  380  and  382  indicate in a general way, the path followed by the drive member  362  during a lancing cycle. During a lancing cycle, the drive member comes down into the penetrating member slot  378  as indicated by arrow  380  through an optional sterility barrier (not shown). The contoured jaws of the drive member then clamp about the penetrating member shaft  366  and move forward in a distal direction so as to drive the penetrating member into the skin of a patient as indicated by arrow  382 .  
       FIGS. 38 and 39  show a portion of a lancing device  390  having a lid  392  that can be opened to expose a penetrating member cartridge cavity  394  for removal of a used penetrating member cartridge  396  and insertion of a new penetrating member cartridge  398 . Depression of button  400  in the direction indicated by arrow  402  raises the drive member  404  from the surface of the penetrating member cartridge  396  by virtue of lever action about pivot point  406 . Raising the lid  392  actuates the lever arm  408  in the direction indicated by arrow  410  which in turn applies a tensile force to cable  412  in the direction indicated by arrow  414 . This action pulls the drive member back away from the penetrating member cartridge  396  so that the penetrating member cartridge  396  can be removed from the lancing device  390 . A new penetrating member cartridge  398  can then be inserted into the lancing device  390  and the steps above reversed in order to position the drive member  404  above the penetrating member cartridge  398  in an operational position.  
       FIGS. 40 and 41  illustrate a penetrating member cartridge  420  that has penetrating member slots  422  on a top side  424  and a bottom side  426  of the penetrating member cartridge  420 . This allows for a penetrating member cartridge  420  of a diameter D to store for use twice the number of penetrating members as a one sided penetrating member cartridge of the same diameter D.  
       FIGS. 42-44  illustrate end and perspective views of a penetrating member cartridge  430  having a plurality of penetrating member slots  432  formed from a corrugated surface  434  of the penetrating member cartridge  430 . Penetrating members  436  are disposed on both sides of the penetrating member cartridge  430 . A sterility barrier  438  is shown disposed over the penetrating member slots  432  in  FIG. 44 .  
       FIGS. 45-48  illustrate embodiments of a penetrating member  440  and drive member  442  wherein the penetrating member  440  has a transverse slot  444  in the penetrating member shaft  446  and the drive member  442  has a protuberance  448  configured to mate with the transverse slot  444  in the penetrating member shaft  446 .  FIG. 45  shows a protuberance  448  having a tapered configuration that matches a tapered configuration of the transverse slot  444  in the penetrating member shaft  446 .  FIG. 46  illustrates an optional alternative embodiment wherein the protuberance  448  has straight walled sides that are configured to match the straight walled sides of the transverse slot  444  shown in  FIG. 46 .  FIG. 47  shows a tapered protuberance  448  that is configured to leave an end gap  450  between an end of the protuberance  448  and a bottom of the transverse slot in the penetrating member shaft  446 .  
       FIG. 48  illustrates a mechanism  452  to lock the drive member  442  to the penetrating member shaft  446  that has a lever arm  454  with an optional bearing  456  on the first end  458  thereof disposed within a guide slot  459  of the drive member  442 . The lever arm  454  has a pivot point  460  disposed between the first end  458  of the lever arm  454  and the second end  462  of the lever arm  454 . A biasing force is disposed on the second end  462  of the lever arm  454  by a spring member  464  that is disposed between the second end  462  of the lever arm  454  and a base plate  466 . The biasing force in the direction indicated by arrow  468  forces the penetrating member contact surface  470  of the drive member  442  against the outside surface of the penetrating member  446  and, in addition, forces the protuberance  448  of the drive member  442  into the transverse slot  444  of the penetrating member shaft  446 .  
      Referring now to  FIG. 49 , another embodiment of a replaceable cartridge  500  suitable for housing a plurality of individually moveable penetrating members (not shown) will be described in further detail. Although cartridge  500  is shown with a chamfered outer periphery, it should also be understood that less chamfered and unchamfered embodiments of the cartridge  500  may also be adapted for use with any embodiment of the present invention disclosed herein. The penetrating members slidably coupled to the cartridge may be a bare lancet or bare elongate member without outer molded part or body pieces as seen in conventional lancet. The bare design reduces cost and simplifies manufacturing of penetrating members for use with the present invention. The penetrating members may be retractable and held within the cartridge so that they are not able to be used again. The cartridge is replaceable with a new cartridge once all the piercing members have been used. The lancets or penetrating members nay be fully contained in the used cartridge so at to minimize the chance of patient contact with such waste.  
      As can be seen in  FIG. 49 , the cartridge  500  may include a plurality of cavities  501  for housing a penetrating member. In this embodiment, the cavity  501  may have a longitudinal opening  502  associated with the cavity. The cavity  501  may also have a lateral opening  503  allowing the penetrating member to exit radially outward from the cartridge. As seen in  FIG. 49 , the outer radial portion of the cavity may be narrowed. The upper portion of this narrowed area may also be sealed or swaged to close the top portion  505  and define an enclosed opening  506  as shown in  FIG. 50 . Optionally, the narrowed area  504  may retain an open top configuration, though in some embodiments, the foil over the gap is unbroken, preventing the penetrating member from lifting up or extending upward out of the cartridge. The narrowed portion  504  may act as a bearing and/or guide for the penetrating member.  FIG. 51  shows that the opening  506  may have a variety of shapes such as but not limited to, circular, rectangular, triangular, hexagonal, square, or combinations of any or all of the previous shapes. Openings  507  (shown in phantom) for other microfluidics, capillary tubes, or the like may also be incorporated in the immediate vicinity of the opening  506 . In some optional embodiments, such openings  507  may be configured to surround the opening  506  in a concentric or other manner.  
      Referring now to  FIG. 52 , the underside of a cartridge  500  will be described in further detail. This figures shows many features on one cartridge  500 . It should be understood that a cartridge may include some, none, or all of these features, but they are shown in  FIG. 52  for ease of illustration. The underside may include indentations or holes  510  close to the inner periphery for purpose of properly positioning the cartridge to engage a penetrating member gripper and/or to allow an advancing device (shown in  FIGS. 56B and 56C ) to rotate the cartridge  500 . Indentations or holes  511  may be formed along various locations on the underside of cartridge  500  and may assume various shapes such as but not limited to, circular, rectangular, triangular, hexagonal, square, or combinations of any or all of the previous shapes. Notches  512  may also be formed along the inner surface of the cartridge  500  to assist in alignment and/or rotation of the cartridge. It should be understood of course that some of these features may also be placed on the topside of the cartridge in areas not occupied by cavities  501  that house the penetrating members. Notches  513  may also be incorporated along the outer periphery of the cartridge. These notches  513  may be used to gather excess material from the sterility barrier  28  (not shown) that may be used to cover the angled portion  514  of the cartridge. In the present embodiment, the cartridge has a flat top surface and an angled surface around the outside. Welding a foil type sterility barrier over that angled surface, the foil folds because of the change in the surfaces which is now at 45 degrees. This creates excess material. The grooves or notches  513  are there as a location for that excess material. Placing the foil down into those grooves  513  which may tightly stretch the material across the 45 degree angled surface. Although in this embodiment the surface is shown to be at 45 degrees, it should be understood that other angles may also be used. For example, the surface may be at any angle between about 3 degrees to 90 degrees, relative to horizontal. The surface may be squared off. The surface may be unchamfered. The surface may also be a curved surface or it may be combinations of a variety of angled surfaces, curved and straights surfaces, or any combination of some or all of the above.  
      Referring now to  FIGS. 53-54 , the sequence in which the cartridge  500  is indexed and penetrating members are actuated will now be described. It should be understood that some steps described herein may be combined or taken out of order without departing from the spirit of the invention. These sequence of steps provides vertical and horizontal movement used with the present embodiment to load a penetrating member onto the driver.  
      As previously discussed, each cavity on the cartridge may be individually sealed with a foil cover or other sterile enclosure material to maintain sterility until or just before the time of use. In the present embodiment, penetrating members are released from their sterile environments just prior to actuation and are loaded onto a launcher mechanism for use. Releasing the penetrating member from the sterile environment prior to launch allows the penetrating member in the present embodiment to be actuated without having to pierce any sterile enclosure material which may dull the tip of the penetrating member or place contaminants on the member as it travels towards a target tissue. A variety of methods may be used accomplish this goal.  
       FIG. 53A  shows one embodiment of penetrating member release device, which in this embodiment is a punch plate  520  that is shown in a see-through depiction for ease of illustration. The punch plate  520  may include a first portion  521  for piercing sterile material covering the longitudinal opening  502  and a second portion  522  for piercing material covering the lateral opening  503 . A slot  523  allows the penetrating member gripper to pass through the punch plate  520  and engage a penetrating member housed in the cartridge  500 . The second portion  522  of the punch plate down to engage sterility barrier angled at about a 45 degree slope. Of course, the slope of the barrier may be varied. The punch portion  522  first contacts the rear of the front pocket sterility barrier and as it goes down, the cracks runs down each side and the barrier is pressed down to the bottom of the front cavity. The rear edge of the barrier first contacted by the punch portion  522  is broken off and the barrier is pressed down, substantially cleared out of the way. These features may be more clearly seen in  FIG. 53B . The punch portion  521  may include a blade portion down the centerline. As the punch comes down, that blade may be aligned with the center of the cavity, cutting the sterility barrier into two pieces. The wider part of the punch  521  then pushes down on the barrier so the they align parallel to the sides of the cavity. This creates a complete and clear path for the gripper throughout the longitudinal opening of the cavity. Additionally, as seen in  FIGS. 53B and 54A , a plurality of protrusion  524  are positioned to engage a cam  FIG. 55A ) which sequences the punching and other vertical movement of punch plate  520  and cartridge pusher  525 . The drive shaft  526  from a force generator (not shown) which is used to actuate the penetrating member  527 .  
      Referring now to FIGS.  54 A-F, the release and loading of the penetrating members are achieved in the following sequence.  FIG. 54A  shows the release and loading mechanism in rest state with a dirty bare penetrating member  527  held in a penetrating member gripper  530 . This is the condition of the device between lancing events. When the time comes for the patient to initiate another lancing event, the used penetrating member is cleared and a new penetrating member is loaded, just prior to the actual lancing event. The patient begins the loading of a new penetrating member by operating a setting lever to initiate the process. The setting lever may operate mechanically to rotate a cam (see  FIG. 55A ) that moves the punch plate  520  and cartridge pusher  525 . In other embodiments, a stepper motor or other mover such as but not limited to, a pneumatic actuator, hydraulic actuator, or the like are used to drive the loading sequence.  
       FIG. 54B  shows one embodiment of penetrating member gripper  530  in more detail. The penetrating member gripper  530  may be in the form of a tuning fork with sharp edges along the inside of the legs contacting the penetrating member. In some embodiments, the penetrating member may be notched, recessed, or otherwise shaped to receive the penetrating member gripper. As the gripper  530  is pushed down on the penetrating member, the legs are spread open elastically to create a frictional grip with the penetrating member such as but not limited to bare elongate wires without attachments molded or otherwise attached thereon. In some embodiments, the penetrating member is made of a homogenous material without any additional attachments that are molded, adhered, glued or otherwise added onto the penetrating member.  
      In some embodiments, the gripper  530  may cut into the sides of the penetrating member. The penetrating member in one embodiment may be about 300 microns wide. The grooves that form in the side of the penetrating member by the knife edges are on the order of about 5-10 microns deep and are quite small. In this particular embodiment, the knife edges allow the apparatus to use a small insertion force to get the gripper onto the penetrating member, compared to the force to remove the penetrating member from the gripper the longitudinal axis of an elongate penetrating member. Thus, the risk of a penetrating member being detached during actuation are reduced. The gripper  530  may be made of a variety of materials such as, but not limited to high strength carbon steel that is heat treated to increased hardness, ceramic, substrates with diamond coating, composite reinforced plastic, elastomer, polymer, and sintered metals. Additionally, the steel may be surface treated. The gripper  130  may have high gripping force with low friction drag on solenoid or other driver.  
      As seen in  FIG. 54C , the sequence begins with punch plate  520  being pushed down. This results in the opening of the next sterile cavity  532 . In some embodiment, this movement of punch plate  520  may also result in the crimping of the dirty penetrating member to prevent it from being used again. This crimping may result from a protrusion on the punch plate bending the penetrating member or pushing the penetrating member into a groove in the cartridge that hold the penetrating member in place through an interference fit. As seen in  FIGS. 53B and 54C , the punch plate  520  has a protrusion or punch shaped to penetrate a longitudinal opening  502  and a lateral opening  503  on the cartridge. The first portion  521  of the punch that opens cavity  532  is shaped to first pierce the sterility barrier and then push, compresses, or otherwise moves sterile enclosure material towards the sides of the longitudinal opening  502 . The second portion  522  of the punch pushes down the sterility barrier at lateral opening or penetrating member exit  503  such that the penetrating member does not pierce any materials when it is actuated toward a tissue site.  
      Referring now to  FIG. 54D , the cartridge pusher  525  is engaged by the cam  550  (not shown) and begins to push down on the cartridge  500 . The punch plate  520  may also travel downward with the cartridge  500  until it is pushed down to it maximum downward position, while the penetrating member gripper  530  remains vertically stationary. This joint downward motion away from the penetrating member gripper  530  will remove the penetrating member from the gripper. The punch plate  520  essentially pushes against the penetrating member with protrusion  534  ( FIG. 55A ), holding the penetrating member with the cartridge, while the cartridge  500  and the punch plate  520  is lowered away from the penetrating member gripper  530  which in this embodiment remains vertically stationary. This causes the stripping of the used penetrating member from the gripper  530  ( FIG. 45D ) as the cartridge moves relative to the gripper.  
      At this point as seen in  FIG. 54E , the punch plate  520  retracts upward and the cartridge  500  is pushed fully down, clear of the gripper  530 . Now cleared of obstructions and in a rotatable position, the cartridge  500  increments one pocket or cavity in the direction that brings the newly released, sterile penetrating member in cavity  532  into alignment with the penetrating member gripper  530 , as see in  FIG. 54F . The rotation of the cartridge occurs due to fingers engaging the holes or indentations  533  on the cartridge, as seen in  FIG. 54A . In some embodiments, these indentations  533  do not pass completely through cartridge  500 . In other embodiments, these indentations are holes passing completely through. The cartridge has a plurality of little indentations  533  on the top surface near the center of the cartridge, along the inside diameter. In the one embodiment, the sterility barrier is cut short so as not to cover these plurality of indentations  533 . It should be understood of course that these holes may be located on bottom, side or other accessible surface. These indentations  533  have two purposes. The apparatus may have one or a plurality of locator pins, static pins, or other keying feature that dos not move. In this embodiment, the cartridge will only set down into positions where the gripper  530  is gripping the penetrating member. To index the cassette, the cartridge is lifted off those pins or other keyed feature, rotated around, and dropped onto those pins for the next position. The rotating device is through the use of two fingers: one is a static pawl and the other one is a sliding finger. They engage with the holes  533 . The fingers are driven by a slider that may be automatically actuated or actuated by the user. This maybe occur mechanically or through electric or other powered devices. Halfway through the stroke, a finger may engage and rotate around the cartridge. A more complete description can be found with text associated with  FIGS. 56B-56C .  
      Referring now to  FIG. 54G , with the sterile penetrating member in alignment, the cartridge  500  is released as indicated by arrows  540  and brought back into contact with the penetrating member gripper  530 . The new penetrating member  541  is inserted into the gripper  530 , and the apparatus is ready to fire once again. After launch and in between lancing events for the present embodiment, the bare lancet or penetrating member  541  is held in place by gripper  530 , preventing the penetrating member from accidentally protruding or sliding out of the cartridge  500 .  
      It should be understood of course, that variations can be added to the above embodiment without departing from the spirit of the invention. For example, the penetrating member  541  may be placed in a parked position in the cartridge  500  prior to launch. As seen in  FIG. 55A , the penetrating member is held by a narrowed portion  542  of the cartridge, creating an interference fit which pinches the proximal end of the penetrating member. Friction from the molding or cartridge holds the penetrating member during rest, preventing the penetrating member from sliding back and forth. Of course, other methods of holding the penetrating member may also be used. As seen in  FIG. 55B  prior to launch, the penetrating member gripper  530  may pull the penetrating member  541  out of the portion  542 . The penetrating member  541  may remain in this portion until actuated by the solenoid or other force generator coupled to the penetrating member gripper. A cam surface  544  may be used to pull the penetrating member out of the portion  542 . This mechanical cam surface may be coupled to the mechanical slider driven by the patient, which may be considered a separate force generator. Thus, energy from the patient extracts the penetrating member and this reduces the drain on the device&#39;s battery if the solenoid or electric driver were to pull out the penetrating member. The penetrating member may be moved forward a small distance (on the order of about 1 mm or less) from its parked position to pull the penetrating member from the rest position gripper. After penetrating tissue, the penetrating member may be returned to the cartridge and eventually placed into the parked position. This may also occur, though not necessarily, through force provided by the patient. In one embodiment, the placing of the lancet into the parked position does not occur until the process for loading a new penetrating member is initiated by the patient. In other embodiments, the pulling out of the parked position occurs in the same motion as the penetrating member actuation. The return into the parked position may also be considered a continuous motion.  
       FIG. 55A  also shows one embodiment of the cam and other surfaces used to coordinate the motion of the punch plate  520 . For example, cam  550  in this embodiment is circular and engages the protrusions  524  on the punch plate  520  and the cartridge pusher  525 .  FIG. 55A  also more clearly shows protrusion  534  which helps to hold the penetrating member in the cartridge  500  while the penetrating member gripper  530  pulls away from the member, relatively speaking. A ratchet surface  552  that rotates with the cam  550  may be used to prevent the cam from rotating backwards. The raising and lower of cartridge  500  and punch plate  50  used to load/unload penetrating members may be mechanically actuated by a variety of cam surfaces, springs, or the like as may be determined by one skilled in the art. Some embodiments may also use electrical or magnetic device to perform the loading, unloading, and release of bare penetrating members. Although the punch plate  520  is shown to be punching downward to displace, remove, or move the foil or other sterile environment enclosure, it should be understood that other methods such as stripping, pulling, tearing, or some combination of one or more of these methods may be used to remove the foil or sterile enclosure. For example, in other embodiments, the punch plate  520  may be located on an underside of the cartridge and punch upward. In other embodiments, the cartridge may remain vertically stationary while other parts such as the penetrating member gripper and punch plate move to load a sterile penetrating member on to the penetrating member gripper.  
       FIG. 55B  also shows other features that may be included in the present apparatus. A fire button  560  may be included for the user to actuate the penetrating member. A front end interface  561  may be included to allow a patient to seat their finger or other target tissue for lancing. The interface  561  may be removable to be cleaned or replaced. A visual display  562  may be included to show device status, lancing performance, error reports, or the like to the patient.  
      Referring now to  FIG. 56A , a mechanical slider  564  used by the patient to load new penetrating member may also be incorporated on the housing. The slider  564  may also be coupled to activate an LCD or visual display on the lancing apparatus. In addition to providing a source of energy to index the cartridge, the slider  564  may also switch the electronics to start the display. The user may use the display to select the depth of lancing or other feature. The display may go back to sleep again until it is activated again by motion of the slider  564 . The underside the housing  566  may also be hinged or otherwise removable to allow the insertion of cartridge  500  into the device. The cartridge  500  may be inserted using technology current used for insertion of a compact disc or other disc into a compact disc player. In one embodiment, there may be a tray which is deployed outward to receive or to remove a cartridge. The tray may be withdrawn into the apparatus where it may be elevated, lowered, or otherwise transported into position for use with the penetrating member driver. In other embodiments, the apparatus may have a slot into which the cartridge is partially inserted at which point a mechanical apparatus will assist in completing insertion of the cartridge and load the cartridge into proper position inside the apparatus. Such device is akin to the type of compact disc player found on automobiles. The insertions/ejection and loading apparatus of these compact disc players uses gears, pulleys, cables, trays, and/or other parts that may be adapted for use with the present invention.  
      Referring now to  FIG. 56B , a more detailed view of one embodiment of the slider  564  is provided. In this embodiment, the slider  564  will move initially as indicated by arrow  567 . To complete the cycle, the patient will return the slider to its home position or original starting position as indicated by arrow  568 . The slider  564  has an arm  569  which moves with the slider to rotate the cam  550  and engage portions  522 . The motion of the slider  564  is also mechanically coupled to a finger  570  which engage the indentations  571  on cartridge  500 . The finger  570  is synchronized to rotate the cartridge  500  by pulling as indicated by arrow  572  in the same plane as the cartridge. It should be understood that in some embodiments, the finger  570  pushes instead of pulls to rotate the cartridge in the correct direction. The finger  570  may also be adapted to engage ratchet surfaces  706  as seen in  FIG. 66  to rotate a cartridge. The finger  570  may also incorporate vertical motion to coordinate with the rising and lowering of the cartridge  500 . The motion of finger  570  may also be powered by electric actuators such as a stepper motor or other device useful for achieving motion.  FIG. 56B  also shows a portion of the encoder  573  used in position sensing.  
      Referring now to  FIG. 56C , a still further view of the slider  564  and arm  569  is shown. The arm  569  moves to engage portion  522  as indicated by arrow  575  and this causes the cam  550  to rotate as indicated by arrow  577 . In this particular embodiment, the cam  550  rotates about ⅛ of an rotation with each pull of the slider  564 . When the slider  564  is return to its home or start position, the arm  569  rides over the portion  522 . The movement of the slider also allows the cam surface  544  to rotate about pivot point  579 . A resilient member  580  may be coupled to the cam surface  544  to cause it to rotate counterclockwise when the arm  569  moves in the direction of arrow  567 . The pin  580  will remain in contact with the arm  569 . As the cam surface  544  rotates a first surface  582  will contact the pin  583  on the gripper block  584  and pull the pin  583  back to park a penetrating member into a coupling or narrowed portion  542  of the cartridge  500  as seen in  FIG. 55A . As the arm  569  is brought back to the home position, the cam surface  544  rotates back and a second surface  586  that rotates clockwise and pushes the penetrating member forward to be released from the narrowed portion  542  resulting in a position as seen in  FIG. 55B . It should be understood that in some embodiments, the release and/or parking of lancet from portion  542  may be powered by the driver  588  without using the mechanical assistance from cam surface  544 .  
      In another embodiment of the cartridge device, a mechanical feature may be included on the cartridge so that there is only one way to load it into the apparatus. For example, in one embodiment holding 50 penetrating members, the cartridge may have 51 pockets or cavities. The 51 st  pocket will go into the firing position when the device is loaded, thus providing a location for the gripper to rest in the cartridge without releasing a penetrating member from a sterile environment. The gripper  530  in that zeroth position is inside the pocket or cavity and that is the reason why one of the pockets may be empty. Of course, some embodiments may have the gripper  530  positioned to grip a penetrating member as the cartridge  500  is loaded into the device, with the patient lancing themselves soon afterwards so that the penetrating member is not contaminated due to prolonged exposure outside the sterile enclosure. That zeroth position may be the start and finish position. The cartridge may also be notched to engaged a protrusion on the apparatus, thus also providing a method for allowing the penetrating member to loaded or unloaded only in one orientation. Essentially, the cartridge  500  may be keyed or slotted in association with the apparatus so that the cartridge  500  can only be inserted or removed at one orientation. For example as seen in  FIG. 56D , the cartridge  592  may have a keyed slot  593  that matches the outline of a protrusion  594  such that the cartridge  592  may only be removed upon alignment of the slot  593  and protrusion  594  upon at the start or end positions. It should be understood that other keyed technology may be used and the slot or key may be located on an outer periphery or other location on the cartridge  592  in manner useful for allowing insertion or removal of the cartridge from only one or a select number of orientations.  
      Referring now to  FIG. 57 , a cross-section of another embodiment of a cavity  600  housing a penetrating member is shown. The cavity  600  may include a depression  602  for allowing the gripper  530  to penetrate sufficiently deeply into the cavity to frictionally engage the penetrating member  541 . The penetrating member may also be housed in a groove  604  that holds the penetrating member in place prior to and after actuation. The penetrating member  541  is lifted upward to clear the groove  604  during actuation and exits through opening  506 .  
      Referring now to  FIG. 58 , another variation on the system according to the present invention will now be described.  FIG. 58  shows a lancing system  610  wherein the penetrating members have their sharpened tip pointed radially inward. The finger or other tissue of the patient is inserted through the center hole  611  to be pierced by the member  612 . The penetrating member gripper  530  coupled to drive force generator  613  operate in substantially the same manner as described in FIGS.  54 A-G. The punch portions  521  and  522  operate in substantially the same manner to release the penetrating members from the sterile enclosures. The punch portion  522  may be placed on the inner periphery of the device, where the penetrating member exit is now located, so that sterile enclosure material is cleared out of the path of the penetrating member exit.  
      Referring now to  FIG. 59 , a still further variation on the lancing system according to the present invention will now be described. In the embodiments shown in  FIGS. 53-54 , the penetrating member gripper  530  approaches the penetrating member from above and at least a portion of the drive system is located in a different plane from that of the cartridge  500 .  FIG. 59  shows an embodiment where the penetrating member driver  620  is in substantially the same plane as the penetrating member  622 . The coupler  624  engages a bent or L shaped portion  626  of the member  622 . The cartridge  628  can rotate to engage a new penetrating member with the coupler  624  without having to move the cartridge or coupler vertically. The next penetrating member rotates into position in the slot provided by the coupler  624 . A narrowed portion of the cartridge acts as a penetrating member guide  630  near the distal end of the penetrating member to align the penetrating member as it exits the cartridge.  
      The coupler  624  may come in a variety of configurations. For example,  FIG. 60A  shows a coupler  632  which can engage a penetrating member  633  that does not have a bent or L-shaped portion. A radial cartridge carrying such a penetrating member  633  may rotate to slide penetrating member into the groove  634  of the coupler  632 .  FIG. 60B  is a front view showing that the coupler  632  may include a tapered portion  636  to guide the penetrating member  633  into the slot  634 .  FIG. 60C  shows an embodiment of the driver  620  using a coupler  637  having a slot  638  for receiving a T-shaped penetrating member. The coupler  637  may further include a protrusion  639  that may be guided in an overhead slot to maintain alignment of the drive shaft during actuation.  
      Referring now to  FIG. 61 , a cartridge  640  for use with an in-plane driver  620  is shown. The cartridge  640  includes an empty slot  642  that allows the cartridge to be placed in position with the driver  620 . In this embodiment, the empty slot  642  allows the coupler  644  to be positioned to engage an unused penetrating member  645  that may be rotated into position as shown by arrow  646 . As seen in  FIG. 61 , the cartridge  640  may also be designed so that only the portion of the penetrating member that needs to remain sterile (i.e. the portions that may actually be penetrating into tissue) are enclosed. As seen in  FIG. 61 , a proximal portion  647  of the penetrating member is exposed. This exposed proximal portion may be about 70% of the penetrating member. In other embodiments it may be between about 69% to about 5% of the penetrating member. The cartridge  640  may further include, but not necessarily, sealing protrusions  648 . These protrusions  648  are releasably coupled to the cartridge  640  and are removed from the cartridge  640  by remover  649  as the cartridge rotates to place penetrating member  645  into the position of the active penetrating member. The sterile environment is broken prior to actuation of the member  645  and the member does not penetrate sterile enclosure material that may dull the tip of the penetrating member during actuation. A fracturable seal material  650  may be applied to the member to seal against an inner peripheral portion of the cartridge.  
      Referring now to  FIG. 62 , a still further embodiment of a cartridge for use with the present invention will be described. This cartridge  652  includes a tapered portion  654  for allowing the coupler  655  to enter the cavity  656 . A narrowed portion  657  guides the penetrating member  658 . The coupler  655  may have, but does not necessarily have, movable jaws  659  that engage to grip the penetrating member  658 . Allowing the coupler to enter the cavity  656  allows the alignment of the penetrating member to be better maintained during actuation. This tapered portion  654  may be adapted for use with any embodiment of the cartridge disclosed herein.  
      Referring now to  FIG. 63 , a linear cartridge  660  for use with the present invention will be described. Although the present invention has been shown in use with radial cartridges, the lancing system may be adapted for use with cartridges of other shapes.  FIGS. 79-83  show other cartridges of varying shapes adaptable for use with the present invention.  FIG. 63  illustrates a cartridge  660  with only a portion  662  providing sterile protection for the penetrating members. The cartridge  660 , however, provides a base  664  on which a penetrating member  665  can rest. This provides a level of protection of the penetrating member during handling. The base  664  may also be shaped to provide slots  666  in which a penetrating member  667  may be held. The slot  666  may also be adapted to have a tapered portion  668 . These configurations may be adapted for use with any of the embodiments disclosed herein, such as the cartridge  652 .  
      Referring now to  FIGS. 64A-64C , a variety of different devices are shown for releasing the sterility seal covering a lateral opening  503  on the cartridge  500 .  FIG. 64A  shows a rotating punch device  670  that has protrusions  672  that punch out the sterility barrier creating openings  674  from which a penetrating member can exit without touching the sterility barrier material.  FIG. 64B  shows a vertically rotating device  676  with shaped protrusions  678  that punch down the sterility barrier  679  as it is rotated to be in the active, firing position.  FIG. 64C  shows a punch  680  which is positioned to punch out barrier  682  when the cartridge is lowered onto the punch. The cartridge is rotated and the punch  680  rotates with the cartridge. After the cartridge is rotated to the proper position and lifted up, the punch  680  is spring loaded or otherwise configured to return to the position to engage the sterility barrier covering the next unused penetrating member.  
      Referring now to  FIG. 65A-65B , another type of punch mechanism for use with a punch plate  520  will now be described. The device shown in  FIGS. 53-54  shows a mechanism that first punches and then rotates or indexes the released penetrating member into position. In this present embodiment, the cartridge is rotated first and then the gripper and punch may move down simultaneously.  FIG. 65A  shows a punch  685  having a first portion  686  and a second portion  687 . As seen in cross-sectional view of  FIG. 65B , the penetrating member gripper  690  is located inside the punch  685 . Thus the penetrating of the sterility barrier is integrated into the step of engaging the penetrating member with the gripper  690 . The punch  685  may include a slot  692  allowing a portion  694  of the gripper  690  to extend upward. A lateral opening  695  is provided from which a penetrating member may exit. In some embodiments, the punch portion  687  is not included with punch  686 , instead relying on some other mechanism such as those shown in  FIGS. 64A-64C  to press down on barrier material covering a lateral opening  503 .  
      Referring now to  FIG. 66 , a still further embodiment of a cartridge according to the present invention will be described.  FIG. 66  shows a cartridge  700  with a plurality of cavities  702  and individual deflectable portions or fingers  704 . The ends of the protective cavities  702  may be divided into individual fingers (such as one for each cavity) on the outer periphery of the disc. Each finger  704  may be individually sealed with a foil cover (not shown for ease of illustration) to maintain sterility until the time of use. Along the inner periphery of the cartridge  700  are raised step portions  706  to create a ratchet type mechanism. As seen in  FIG. 67 , a penetrating member  708  may be housed in each cavity. The penetrating member may rest on a raised portion  710 . A narrowed portion  712  pinches the proximal portions of the penetration member  708 . Each cavity may include a wall portion  714  into which the penetrating member  708  may be driven after the penetrating member has been used.  FIG. 68  shows the penetrating member gripper  716  lowered to engage a penetrating member  708 . For ease of illustration, a sterility barrier covering each of the cavities is not shown.  
      Referring now to  FIGS. 69A-69L , the sequence of steps for actuating a penetrating member in a cartridge  700  will be described. It should be understood that in other embodiments, steps may be combined or reduced without departing from the spirit of the present invention. The last penetrating member to be used may be left in a retracted position, captured by a gripper  716 . The end of the protective cavity  704  may be deflected downward by the previous actuation. The user may operate a mechanism such as but not limited to a thumbwheel, lever, crank, slider, etc . . . that advances a new penetrating member  720  into launch position as seen in  FIG. 69A . The mechanism lifts a bar that allows the protective cavity to return to its original position in the plane of the disc.  
      In this embodiment as shown in  FIG. 69B , the penetrating member guide  722  presses through foil in rear of pocket to “home” penetrating member and control vertical clearance. For ease of illustration, actuation devices for moving the penetrating member guide  722  and other mechanisms are not shown. They may be springs, cams, or other devices that can lower and move the components shown in these figures. In some embodiments, the cartridge  700  may be raised or lowered to engage the penetrating member guide  722  and other devices.  
      As seen in  FIG. 69C , the plough or sterile enclosure release device  724  is lowered to engage the cartridge  700 . In some embodiments, the disc or cartridge  700  may raised part way upward until a plough or plow blade  724  pierces the sterility barrier  726  which may be a foil covering.  
      Referring now to  FIG. 69D , the plough  724  clears foil from front of pocket and leaves it attached to cartridge  700 . The plough  724  is driven radially inward, cutting open the sterility barrier and rolling the scrap into a coil ahead of the plough. Foil naturally curls over and forms tight coil when plough lead angle is around 55 degs to horizontal. If angle of the plough may be between about 60-40 degs, preferably closer to 55 degs. In some embodiments, the foil may be removed in such a manner that the penetrating member does not need to pierce any sterile enclosure materials during launch.  
      Referring now to  FIG. 69E , the gripper  716  may be lowered to engage the bare penetrating member or piercing member  720 . Optionally, the disc or cartridge  8000  may be raised until the penetrating member  720  is pressed firmly into the gripper  716 . Although not shown in the present figure, the penetrating member driver or actuator of the present embodiment may remain in the same horizontal plane as the penetrating member.  
      As seen in  FIG. 69F , a bar  730  may be pressed downward on the outer end  732  of the protective cavity to deflect it so it is clear of the path of the penetrating member. In the present embodiment, the bar  730  is shaped to allow the bare penetrating member  720  to pass through. It should be understood that other shapes and orientations of the bar (such as contacting only one side or part of end  732 ) may be used to engage the end  732 .  
      Referring now to  FIG. 69G , an electrical solenoid or other electronic or feedback controllable drive may actuate the gripper  716  radially outward, carrying the bare penetrating member  720  with it. The bare penetrating member projects from the protective case and into the skin of a finger or other tissue site that has been placed over the aperture of the actuator assembly. Suitable penetrating member drivers are described in commonly assigned, copending U.S. patent application Ser. No. 10/127,395 (Attorney Docket No. 38187-2551) filed Apr. 19, 2002.  
      Referring now to  FIG. 69H , the solenoid or other suitable penetrating member driver retracts the bare penetrating member  720  into a retracted position where it parks until the beginning of the next lancing cycle.  
      Referring now to  FIG. 69I , bar  730  may be released so that the end  150  returns to an in-plane configuration with the cartridge  800 .  
      As seen in  FIG. 69J , the gripper  716  may drive a used bare penetrating member radially outward until the sharpened tip is embedded into a plastic wall  714  at or near the outward end  732  of the cavity thus immobilizing the contaminated penetrating member.  
      As seen in  FIGS. 69K and 69L , the plough  724 , the gripper  716 , and penetrating member guide  722  may all be disengaged from the bare penetrating member  720 . Optionally, it should be understood that the advance mechanism may lower the cartridge  700  from the gripper  716 . The used penetrating member, restrained by the tip embedded in plastic, and by the cover foil at the opposite end, is stripped from the gripper. The disc or cartridge  700  may be rotated until a new, sealed; sterile penetrating member is in position under the launch mechanism.  
      Referring now to  FIGS. 70 and 71 , one object for some embodiments of the invention is to include blood sampling and sensing on this penetrating member actuation device. In the present embodiment, the drive mechanism (gripper  738  and solenoid drive coil  739 ) may be used to drive a penetrating member into the skin and couple this lancing event to acquire the blood sample as it forms at the surface of the finger. In a first embodiment shown in  FIG. 70 , microfluidic module  740  bearing the analyte detecting member chemistry and detection device  742  ( FIG. 71 ) is couple on to the shaft of the penetrating member  720 . The drive cycle described above may also actuate the module  740  so that it rests at the surface of the finger to acquire blood once the penetrating member retracts from the wound. The module  740  is allowed to remain on the surface of the finger or other tissue site until the gripper  738  has reached the back end  744  of the microfluidics module  740 , at which point the module is also retracted into the casing. The amount of time the module  740  remains on the finger, in this embodiment, may be varied based on the distance the end  744  is located and the amount of time it takes the gripper to engage it on the withdrawal stroke. The blood filled module  740 , filled while the module remains on pierced tissue site, may then undergo analyte detection by means such as optical or electrochemical sensing.  
      The blood may be filled in the lumen that the penetrating member was in or the module may have separately defined sample chambers to the side of the penetrating member lumen. The analyte detecting member may also be placed right at the immediate vicinity or slightly setback from the module opening receiving blood so that low blood volumes will still reach the analyte detecting member. In some embodiments, the analyte sensing device and a visual display or other interface may be on board the apparatus and thus provide a readout of analyte levels without need to plug apparatus or a test strip into a separate reader device. As seen in  FIG. 71 , the cover  746  may also be clear to allow for light to pass through for optical sensing. The analyte detecting member may be used with low volumes such as less than about 1 microliter of sample, preferably less than about 0.6 microliter, more preferably less than about 0.3 microliter, and most preferably less than about 0.1 microliter of sample.  
      In another embodiment as seen in  FIG. 72 , sensing elements  760  may be directly printed or formed on the top of bottom of the penetrating member cartridge  700 , depending on orientation. The bare penetrating member  720  is then actuated through a hole  762  in the plastic facing, withdrawn into the radial cavity followed by the blood sample. Electrochemical or optical detection for analyte sensing may then be carried out ( FIG. 72 ). Again the cavity  766  may have a clear portion to allow light to pass for optical sensing. In one embodiment, a multiplicity of miniaturized analyte detecting member fields may be placed on the floor of the radial cavity as shown in  FIG. 72  or on the microfluidic module shown in  FIG. 71  to allow many tests on a single analyte form a single drop of blood to improve accuracy and precision of measurement. Although not limited in this manner, additional analyte detecting member fields or regions may also be included for calibration or other purposes.  
      Referring now to  FIG. 73 , a still further embodiment of a cartridge according to the present invention will be described.  FIG. 73  shows one embodiment of a cartridge  800  which may be removably inserted into an apparatus for driving penetrating members to pierce skin or tissue. The cartridge  800  has a plurality of penetrating members  802  that may be individually or otherwise selectively actuated so that the penetrating members  802  may extend outward from the cartridge, as indicated by arrow  804 , to penetrate tissue. In the present embodiment, the cartridge  800  may be based on a flat disc with a number of penetrating members such as, but in no way limited to, (25, 50, 75, 100, . . . ) arranged radially on the disc or cartridge  800 . It should be understood that although the cartridge  800  is shown as a disc or a disc-shaped housing, other shapes or configurations of the cartridge may also work without departing from the spirit of the present invention of placing a plurality of penetrating members to be engaged, singly or in some combination, by a penetrating member driver.  
      Each penetrating member  802  may be contained in a cavity  806  in the cartridge  800  with the penetrating member&#39;s sharpened end facing radially outward and may be in the same plane as that of the cartridge. The cavity  806  may be molded, pressed, forged, or otherwise formed in the cartridge. Although not limited in this manner, the ends of the cavities  806  may be divided into individual fingers (such as one for each cavity) on the outer periphery of the disc. The particular shape of each cavity  806  may be designed to suit the size or shape of the penetrating member therein or the amount of space desired for placement of the analyte detecting members  808 . For example and not limitation, the cavity  806  may have a V-shaped cross-section, a U-shaped cross-section, C-shaped cross-section, a multi-level cross section or the other cross-sections. The opening  810  through which a penetrating member  802  may exit to penetrate tissue may also have a variety of shapes, such as but not limited to, a circular opening, a square or rectangular opening, a U-shaped opening, a narrow opening that only allows the penetrating member to pass, an opening with more clearance on the sides, a slit, a configuration as shown in  FIG. 75 , or the other shapes.  
      In this embodiment, after actuation, the penetrating member  802  is returned into the cartridge and may be held within the cartridge  800  in a manner so that it is not able to be used again. By way of example and not limitation, a used penetrating member may be returned into the cartridge and held by the launcher in position until the next lancing event. At the time of the next lancing, the launcher may disengage the used penetrating member with the cartridge  800  turned or indexed to the next clean penetrating member such that the cavity holding the used penetrating member is position so that it is not accessible to the user (i.e. turn away from a penetrating member exit opening). In some embodiments, the tip of a used penetrating member may be driven into a protective stop that hold the penetrating member in place after use. The cartridge  800  is replaceable with a new cartridge  800  once all the penetrating members have been used or at such other time or condition as deemed desirable by the user.  
      Referring still to the embodiment in  FIG. 73 , the cartridge  800  may provide sterile environments for penetrating members via seals, foils, covers, polymeric, or similar materials used to seal the cavities and provide enclosed areas for the penetrating members to rest in. In the present embodiment, a foil or seal layer  820  is applied to one surface of the cartridge  800 . The seal layer  820  may be made of a variety of materials such as a metallic foil or other seal materials and may be of a tensile strength and other quality that may provide a sealed, sterile environment until the seal layer  820  is penetrate by a suitable or penetrating device providing a preselected or selected amount of force to open the sealed, sterile environment. Each cavity  806  may be individually sealed with a layer  820  in a manner such that the opening of one cavity does not interfere with the sterility in an adjacent or other cavity in the cartridge  800 . As seen in the embodiment of  FIG. 73 , the seal layer  820  may be a planar material that is adhered top a top surface of the cartridge  800 .  
      Depending on the orientation of the cartridge  800  in the penetrating member driver apparatus, the seal layer  820  may be on the top surface, side surface, bottom surface, or other positioned surface. For ease of illustration and discussion of the embodiment of  FIG. 73 , the layer  820  is placed on a top surface of the cartridge  800 . The cavities  806  holding the penetrating members  802  are sealed on by the foil layer  820  and thus create the sterile environments for the penetrating members. The foil layer  820  may seal a plurality of cavities  806  or only a select number of cavities as desired.  
      In a still further feature of  FIG. 73 , the cartridge  800  may optionally include a plurality of analyte detecting members  808  on a substrate  822  which may be attached to a bottom surface of the cartridge  800 . The substrate may be made of a material such as, but not limited to, a polymer, a foil, or other material suitable for attaching to a cartridge and holding the analyte detecting members  808 . As seen in  FIG. 73 , the substrate  822  may hold a plurality of analyte detecting members, such as but not limited to, about 10-50, 50-100, or other combinations of analyte detecting members. This facilitates the assembly and integration of analyte detecting members  808  with cartridge  800 . These analyte detecting members  808  may enable an integrated body fluid sampling system where the penetrating members  802  create a wound tract in a target tissue, which expresses body fluid that flows into the cartridge for analyte detection by at least one of the analyte detecting members  808 . The substrate  822  may contain any number of analyte detecting members  808  suitable for detecting analytes in cartridge having a plurality of cavities  806 . In one embodiment, many analyte detecting members  808  may be printed onto a single substrate  822  which is then adhered to the cartridge to facilitate manufacturing and simplify assembly. The analyte detecting members  808  may be electrochemical in nature. The analyte detecting members  808  may further contain enzymes, dyes, or other detectors which react when exposed to the desired analyte. Additionally, the analyte detecting members  808  may comprise of clear optical windows that allow light to pass into the body fluid for analyte analysis. The number, location, and type of analyte detecting member  808  may be varied as desired, based in part on the design of the cartridge, number of analytes to be measured, the need for analyte detecting member calibration, and the sensitivity of the analyte detecting members. If the cartridge  800  uses an analyte detecting member arrangement where the analyte detecting members are on a substrate attached to the bottom of the cartridge, there may be through holes (as shown in  FIG. 76 ), wicking elements, capillary tube or other devices on the cartridge  800  to allow body fluid to flow from the cartridge to the analyte detecting members  808  for analysis. In other configurations, the analyte detecting members  808  may be printed, formed, or otherwise located directly in the cavities housing the penetrating members  802  or areas on the cartridge surface that receive blood after lancing.  
      The use of the seal layer  820  and substrate or analyte detecting member layer  822  may facilitate the manufacture of these cartridges  10 . For example, a single seal layer  820  may be adhered, attached, or otherwise coupled to the cartridge  800  as indicated by arrows  824  to seal many of the cavities  806  at one time. A sheet  822  of analyte detecting members may also be adhered, attached, or otherwise coupled to the cartridge  800  as indicated by arrows  825  to provide many analyte detecting members on the cartridge at one time. During manufacturing of one embodiment of the present invention, the cartridge  800  may be loaded with penetrating members  802 , sealed with layer  820  and a temporary layer (not shown) on the bottom where substrate  822  would later go, to provide a sealed environment for the penetrating members. This assembly with the temporary bottom layer is then taken to be sterilized. After sterilization, the assembly is taken to a clean room (or it may already be in a clear room or equivalent environment) where the temporary bottom layer is removed and the substrate  822  with analyte detecting members is coupled to the cartridge as shown in  FIG. 73 . This process allows for the sterile assembly of the cartridge with the penetrating members  802  using processes and/or temperatures that may degrade the accuracy or functionality of the analyte detecting members on substrate  822 . As a nonlimiting example, the entire cartridge  800  may then be placed in a further sealed container such as a pouch, bag, plastic molded container, etc . . . to facilitate contact, improve ruggedness, and/or allow for easier handling.  
      In some embodiments, more than one seal layer  820  may be used to seal the cavities  806 . As examples of some embodiments, multiple layers may be placed over each cavity  806 , half or some selected portion of the cavities may be sealed with one layer with the other half or selected portion of the cavities sealed with another sheet or layer, different shaped cavities may use different seal layer, or the like. The seal layer  820  may have different physical properties, such as those covering the penetrating members  802  near the end of the cartridge may have a different color such as red to indicate to the user (if visually inspectable) that the user is down to say 10, 5, or other number of penetrating members before the cartridge should be changed out.  
      Referring now to  FIGS. 74 and 75 , one embodiment of the microfluidics used with the analyte detecting members  808  in cartridge  800  will now be described. For ease of illustration, the shape of cavity  806  has been simplified into a simple wedge shape. It should be understood that more sophisticated configurations such as that shown in  FIG. 73  may be used.  FIG. 74  shows a channel  826  that assists in drawing body fluid towards the analyte detecting members  808 . In the present embodiment, two analyte detecting members  808  are shown in the cavity  806 . This is purely for illustrative purposes as the cavity  806  may have one analyte detecting member or any other number of analyte detecting members as desired. Body fluid entering cavity  806 , while filling part of the cavity, will also be drawn by capillary action through the groove  826  towards the analyte detecting members  808 . The analyte detecting members  808  may all perform the same analysis, they may each perform different types of analysis, or there may be some combination of the two (some sensors perform same analysis while others perform other analysis).  
       FIG. 75  shows a perspective view of a cutout of the cavity  806 . The penetrating member  802  (shown in phantom) is housed in the cavity  806  and may extend outward through a penetrating member exit opening  830  as indicated by arrow  832 . The position of the tip of penetrating member  802  may vary, such as being near the penetrating member exit port or spaced apart from the exit. The location of the tip relative to the analyte detecting member  808  may also be varied, such as being spaced apart or away from the analyte detecting member or collocated or in the immediate vicinity of the analyte detecting member. Fluid may then enter the cavity  806  and directed by channel  826 . The channel  826  as shown in  FIG. 75  is a groove that is open on top. The channel  826  may be entirely a groove with an open top or it may have a portion that is has a sealed top forming a lumen, or still further, the groove may be closed except for an opening near the penetrating member exit opening  830 . It should be understood that capillary action can be achieved using a groove having one surface uncovered. In some embodiments, the analyte detecting member  808  is positioned close to the penetrating member exit opening  830  so that the analyte detecting member  808  may not need a capillary groove or channel to draw body fluid, such as in  FIG. 78 .  
      As seen in  FIGS. 75 and 76 , the cavity  806  may include the substrate  822  coupled to its bottom surface containing the analyte detecting members  808 . With the analyte detecting members  808  located on the underside of the cartridge  800  as seen in the embodiment of  FIG. 76 , the cartridge  800  may include at least one through hole  834  to provide a passage for body fluid to pass from the cavity  806  to the analyte detecting member  808 . The size, location, shape, and other features of the through hole  834  may be varied based on the cavity  806  and number of analyte detecting members  808  to be provided. In other embodiments, wicking elements or the like may be used to draw body fluid from the groove  826  to down to the analyte detecting member  808  via the through hole or holes  834 .  
      Referring now to  FIG. 77 , a variety of groove and analyte detecting member configurations are shown on a single cartridge. These configurations are shown only for illustrative purposes and a single cartridge may not incorporate each of these configurations. Some embodiments may use any of the detecting members, singly or in combination. It should be understood, however, that analyte detecting member configuration could be customized for each cavity, such as but not limited to, using a different number and location of analyte detecting members depending lancing variables associated with that cavity, such as but not limited to, the time of day of the lancing event, the type of analyte to be measured, the test site to be lanced, stratum corneum hydration, or other lancing parameter. As a nonlimiting example, the detecting members may be moved closer towards the outer edge of the disc, more on the side walls, any combination, or the like.  
       FIG. 77  shows a penetrating member  802  in a cavity  838  with three analyte detecting members  808  in the cavity. For ease of illustration, the penetrating member  802  is omitted from the remaining cavities so that the analyte detecting member configurations can be more easily seen. Cavity  840  has a channel  826  with two analyte detecting members  808 . Cavity  842  has a channel  844  coupled to a single analyte detecting member  808 . Cavities  846  and  848  have one and two analyte detecting members  808 , respectively. The analyte detecting members  808  in those cavities may be located directly at the penetrating member exit from the cartridge or substantially at the penetrating member exit. Other analyte detecting member configurations are also possible, such as but not limited to, placing one or more analyte detecting members on a side wall of the cavity, placing the analyte detecting members in particular arrays (for example, a linear array, triangular array, square array, etc . . . ) on the side wall or bottom surface, using mixed types of analyte detecting members (for example, electrochemical and optical, or some other combination), or mixed positioning of analyte detecting members (for example, at least one analyte detecting member on the substrate below the cartridge and at least one analyte detecting member in the cavity).  
       FIG. 78  shows an embodiment of cartridge  800  where the analyte detecting member  850  is located near the distal end of cavity  806 . The analyte detecting member  850  may be formed, deposited, or otherwise attached there to the cartridge  800 . In another embodiment, the analyte detecting member  850  may be a well or indentation having a bottom with sufficient transparency to allow an optical analyte detecting member to detect analytes in fluid deposited in the well or indentation. The well or indentation may also include some analyte reagent that reacts (fluoresces, changes colors, or presents other detectable qualities) when body fluid is placed in the well. In a still further embodiment, analyte detecting member  850  may be replaced with a through hole that allow fluid to pass there through. An analyte detecting member  808  on a substrate  822  may be attached to the underside of the cartridge  800 , accessing fluid passing from the cavity  806  down to the analyte detecting member  808 .  
      As mentioned above, the analyte detecting members  808  may also be placed right at the immediate vicinity or slightly setback from the module opening receiving blood so that low blood volumes will still reach the analyte detecting member. The analyte detecting members  808  may be used with low volumes such as less than about 1 microliter of sample, preferably less than about 0.6 microliter, more preferably less than about 0.3 microliter, and most preferably less than about 0.1 microliter of sample. Analyte detecting members  808  may also be directly printed or formed on the bottom of the penetrating member cartridge  800 . In one embodiment, a multiplicity of miniaturized analyte detecting member fields may be placed on the floor of the radial cavity or on the microfluidic module to allow many tests on a single analyte form a single drop of blood to improve accuracy and precision of measurement. Although not limited in this manner, additional analyte detecting member fields or regions may also be included for calibration or other purposes.  
      Referring now to  FIGS. 79-84 , further embodiments of the cartridge  800  will now be described.  FIG. 79  shows a cartridge  860  having a half-circular shape.  FIG. 80  shows a cartridge  862  in the shape of a partial curve.  FIG. 80  also shows that the cartridges  862  may be stacked in various configurations such as vertically, horizontally, or in other orientations.  FIG. 81  shows a cartridge  864  having a substantially straight, linear configuration.  FIG. 82  shows a plurality of cartridges  864  arranged to extend radially outward from a center  866 . Each cartridge may be on a slide (not shown for simplicity) that allows the cartridge  864  to slide radially outward to be aligned with a penetrating member launcher. After use, the cartridge  864  is slide back towards the center  866  and the entire assembly is rotated as indicated by arrow  868  to bring a new cartridge  864  into position for use with a penetrating member driver.  FIG. 83  shows a still further embodiment where a plurality of cartridges  800  may be stacked for use with a penetrating member driver (see  FIG. 85 ). The driver may be moved to align itself with each cartridge  800  or the cartridges may be moved to alight themselves with the driver.  FIG. 84  shows a still further embodiment where a plurality of cartridge  864  are coupled together with a flexible support to define an array. A roller  870  may be used to move the cartridges  864  into position to be actuated by the penetrating member driver  872 .  
      Referring now to  FIG. 85 , one embodiment of an apparatus  880  using a radial cartridge  800  with a penetrating member driver  882  is shown. A contoured surface  884  is located near a penetrating member exit port  886 , allowing for a patient to place their finger in position for lancing. Although not shown, the apparatus  880  may include a human readable or other type of visual display to relay status to the user. The display may also show measured analyte levels or other measurement or feedback to the user without the need to plug apparatus  880  or a separate test strip into a separate analyte reader device. The apparatus  880  may include a processor or other logic for actuating the penetrating member or for measuring the analyte levels. The cartridge  800  may be loaded into the apparatus  880  by opening a top housing of the apparatus which may be hinged or removably coupled to a bottom housing. The cartridge  800  may also drawn into the apparatus  880  using a loading mechanism similar in spirit to that found on a compact disc player or the like. In such an embodiment, the apparatus may have a slot (similar to a CD player in an automobile) that allows for the insertion of the cartridge  800  into the apparatus  880  which is then automatically loaded into position or otherwise seated in the apparatus for operation therein. The loading mechanism may be mechanically powered or electrically powered. In some embodiments, the loading mechanism may use a loading tray in addition to the slot. The slot may be placed higher on the housing so that the cartridge  800  will have enough clearance to be loaded into the device and then dropped down over the penetrating member driver  882 . The cartridge  800  may have an indicator mark or indexing device that allows the cartridge to be properly aligned by the loading mechanism or an aligning mechanism once the cartridge  800  is placed into the apparatus  880 . The cartridge  800  may rest on a radial platform that rotates about the penetrating member driver  882 , thus providing a method for advancing the cartridge to bring unused penetrating members to engagement with the penetrating member driver. The cartridge  800  on its underside or other surface, may shaped or contoured such as with notches, grooves, tractor holes, optical markers, or the like to facilitate handling and/or indexing of the cartridge. These shapes or surfaces may also be varied so as to indicate that the cartridge is almost out of unused penetrating members, that there are only five penetrating members left, or some other cartridge status indicator as desired.  
      A suitable method and apparatus for loading penetrating members has been described previously in commonly assigned, copending U.S. patent applications Attorney Docket 38187-2589 and 38187-2590, and are included here by reference for all purposes. Suitable devices for engaging the penetrating members and for removing protective materials associated with the penetrating member cavity are described in commonly assigned, copending U.S. patent applications Attorney Docket 38187-2601 and 38187-2602, and are included here by reference for all purposes. For example in the embodiment of  FIG. 78 , the foil or seal layer  820  may cover the cavity by extending across the cavity along a top surface  890  and down along the angled surface  892  to provide a sealed, sterile environment for the penetrating member and analyte detecting members therein. A piercing element described in U.S. patent applications Attorney Docket 38187-2602 has a piercing element and then a shaped portion behind the element which pushes the foil to the sides of the cavity or other position so that the penetrating member  802  may be actuated and body fluid may flow into the cavity.  
      Referring now to  FIG. 86 , a still further embodiment of a lancing system according to the present invention will be described. A radial cartridge  500  may be incorporated for use with a penetrating member driver  882 . A penetrating member may be driven outward as indicated by arrow  894 . A plurality of analyte detecting members are presented on a roll  895  that is laid out near a penetrating member exit. The roll  895  may be advanced as indicated by arrow  896  so that used analyte detecting members are moved away from the active site. The roll  895  may also be replaced by a disc holding a plurality of analyte detecting members, wherein the analyte detecting member disc (not shown) is oriented in a plane substantially orthogonal to the plane of cartridge  500 . The analyte detecting member disc may also be at other angles not parallel to the plane of cartridge  500  so as to be able to rotate and present new, unused analyte detecting member in sequence with new unused penetrating members of cartridge  500 .  
      Referring now to  FIG. 87A , the cartridge  500  provides a high density packaging system for a lancing system. This form factor allows a patient to load a large number penetrating members through a single cartridge while maintaining a substantially handheld device. Of course such a cartridge  500  may also be used in non-handheld devices. The present cartridge  500  provide a high test density per volume of the disposable. For embodiments of a cartridge that includes analyte detecting members in addition to penetrating members such as cartridge  800 , the density may also be measured in terms of density of analyte detecting members and penetrating members in a disposable. In other embodiments, the density may also be expressed in terms of analyte detecting members per disposable. For example, by taking the physical volume of one embodiment or the total envelope, this number can be divided by the number of penetrating members or number of tests. This result is the volume per penetrating member or per test in a cassetted fashion. For example, in one embodiment of the present invention, the total volume of the cartridge  500  is determined to be 4.53 cubic centimeters. In this one embodiment, the cartridge  500  holds 50 penetrating members. Dividing the volume by 50, the volume per test is arrived at 0.090 cubic centimeters. Conventional test devices such as drum is in the range of 0.720 or 0.670 cubic centimeters and that is simply the volume to hold a plurality of test strips. This does not include penetrating members as does the present embodiment  800 . Thus, the present embodiment is at a substantially higher density. Even a slightly lower density device having penetrating members and analyte detecting members in the 0.500 cubic centimeter range would be a vast improvement over known devices since the numbers listed above for known devices does not include penetrating members, only packaging per test strip.  
      Each penetrating member (or penetrating member and analyte detecting member, as the case may be) may have a packing density, or occupied volume, in cartridge  500 . In various embodiments, the packing density or occupied volume of each penetrating member in cartridge  500  may be no more than about 0.66 cm3, 0.05 cm3, 0.4 cm3, 0.3 cm3, 0.2 cm3, 0.1 cm3, 0.075 cm3, 0.05 cm3, 0.025 cm3, 0.01 cm3, 0.090 cm3, 0.080 cm3, and the like. These numbers applicable to volumes for penetrating members alone, or for combined penetrating members and analyte detecting members. In other words, the volume required for each penetrating member does not exceed 0.66 cm3/penetrating member, 0.05 cm3/penetrating member, 0.4 cm3/penetrating member, 0.3 cm3/penetrating member, 0.2 cm3/penetrating member, 0.1 cm3/penetrating member, 0.075 cm3/penetrating member, 0.05 cm3/penetrating member, 0.025 cm3/penetrating member, 0.01 cm3/penetrating member, 0.090 cm3/penetrating member and the like. So, if the total package volume of the cartridge is defined as X and the cartridge includes Y number of penetrating members, penetrating members and test area, or other unit  395 , the volume for each unit does not exceed 0.66 cm3, 0.05 cm3, 0.4 cm3, 0.3 cm3, 0.2 cm3, 0.1 cm3, 0.075 cm3, 0.05 cm3, 0.025 cm3, 0.01 cm3, 0.090 cm3, 0.080 cm3, and the like.  
      Referring now to  FIG. 87B , a still further embodiment of a cartridge according to the present invention will now be described.  FIG. 87B  shows a cross-section of a conical shaped cartridge with the penetrating member being oriented in one embodiment to move radially outward as indicated by arrow  897 . In another embodiment, the penetrating member may be oriented to move radially inward as indicated by arrow  895 . The gripper may be positioned to engage the penetrating member from an inner surface or an outer surface of the cartridge.  
      Referring now to  FIG. 88 , nanowires may also be used to create low volume analyte detecting members used with the cartridge  800 . Further details of a nanowire device is described in commonly assigned, copending U.S. Provisional Patent Application Ser. No. 60/433,286 (Attorney Docket No. 38187-2605) filed Dec. 13, 2002, fully incorporated herein by reference for all purposes. These nanowire analyte detecting members  898  may be incorporated into the cavity  806  housing the penetrating member  802 . They may be placed on the floor or bottom surface of the cavity  806 , on the wall, on the top surface, or any combinations of some or all of these possibilities. The analyte detecting members  898  may be designed to have different sensitivity ranges so as to enhance the overall sensitivity of an array of such analyte detecting members. Methods to achieve this may include, but are not limited to, using nanowires of varying sizes, varying the number of nanowires, or varying the amount of glucose oxidase or other glucose detection material on the nanowires. These nanowire analyte detecting members may be designed to use low volumes of body fluid for each sample, due to their size. In some embodiments, each of the analyte detecting members are accurate using volumes of body fluid sample less than about 500 nanoliters. In some embodiments, each of the analyte detecting members are accurate using volumes of body fluid sample less than about 300 nanoliters. In still other embodiments, each analyte detecting member is accurate with less than about 50 nanoliters, less than about 30 nanoliters, less than about 10 nanoliters, less than about 5 nanoliters, and less than about 1 nanoliters of body fluid sample. In some embodiments, the combined array of analyte detecting members uses less than 300 nanoliters of body fluid to arrive at an analyte measurement.  
      Referring now to  FIG. 89 , a still further embodiment of the present invention will be described.  FIG. 89  shows one embodiment of an optical illumination system  910  for use with optical analyte detecting members ( FIG. 91 ) that may be in contact with a body fluid sample. The overall system may include a plurality of analyte detecting members which provide some optical indicator, a light source  912  for providing light to shine on the analyte detecting members, at least one light detector  914 , and a processor (not shown). The analyte detecting member or analyte detecting members are exposed to a sample of the fluid of unknown composition. A plurality of analyte detecting members may be arranged into an array of analyte detecting members exposed to one fluid sample, each group targeting a specific analyte and may contain an analyte-specific chemical that interacts more specifically with one analyte than with some other analytes to be analyzed. Each analyte detecting member may also have different sensitivity ranges so as to maximize overall sensitivity of an array of such analyte detecting members. The light source  912  shines light on at least one analyte detecting member to cause light interaction. The differences in the analyte detecting members may lead to differences in the light interaction. The light detector detects the light interaction by the analyte detecting members. The processor analyzes the light interaction by the analyte detecting members to take into account interference in light interaction among the analytes, thereby determining the concentration of the desired analyte in the fluid.  
      Referring still to the embodiment of  FIG. 89 , the light source  912  may be but is not limited to an LED. An alternative LED  915  may also be used with the present invention. Light, illumination, or excitation energy from LED  912  travels along a path through a pinhole  916 , a filter  917 , and a lens  918 . The light then comes into contact with a beamsplitter  919  such as a dichroic mirror or other device useful for beamsplitting. The light is then directed towards lens  920  as indicated by arrow  921 . The lens  920  focuses light onto the analyte detecting member ( FIG. 91 ). This excitation energy may cause a detectable optical indicator from the analyte detecting member. By way of example and not limitation, fluorescence energy may be reflected bay up the lens  920 . This energy passes through the beamsplitter  919  and to lens  922  which is then received by detector  914  as indicated by arrow  923 . The detector  914  measures the energy and this information is passed on to the processor (not shown) to determine analyte levels. The illumination system  910  may also include cells  924  on the disc surface. In this specific embodiment, a penetrating member  925  drive by a force generator  926  such as but not limited to a solenoid may be used to obtain the fluid sample. A detent  927  may also be included with the device along with other bare lancets or penetrating members  928 .  
      Referring now to  FIG. 90 , another embodiment of the illumination system  910  is shown for use with a cartridge  929 . Cartridge  929  is similar to cartridge  800 . Cartridge  929  is a single cartridge having a plurality of penetrating members and a plurality of optical analyte detecting members (not shown). The cartridge  929  further includes a plurality of optically transparent portions  930  which may be but is not limited to windows or the like for the light from LED  912  to shine into a cavity of the cartridge  929 . In one embodiment, each cavity of the cartridge  929  may include at least one transparent portion  930 . This allows the light to generate energy that may be read by analyte detecting member  914 . The cartridge  929  may be used a driver  882  to actuate penetrating members and the cartridge  929  may rotate as indicated by arrow  931 .  
      Referring now to  FIG. 91 , a cross-section of a similar embodiment of the illumination system is shown. This system  932  has source  912  with a lens  933  having an excitation filter  934 . This excitation filter  934 , in one embodiment, only allows excitation energy to pass. This filter  934  allows the excitation energy to pass to dichroic mirror  935 , but does not let it return to source  912 . Excitation energy is reflected down as indicated by arrow  936 . Lens  937  focuses the energy to optical analyte detecting member  938 . Fluorescence energy  939  passes through the dichroic mirror  935  and towards a fluorescent filter  940 . In one embodiment, the fluorescent filter  940  only allows fluorescent energy to pass through to lens  941 . Thus, the detector  914  only receives fluorescent energy from the analyte detecting member  938 . It should be understood of course, that the filter may be changed to allow the type of energy being generated by analyte detecting member  938  to pass. In some embodiments, no filter may be used. The dichroic mirror  935  may be a Bk7 substrate, 63×40×8 mm. The filters may also be a Bk7 substrate about 40 mm in diameter and about 6 mm thick. The lens  933 ,  937 , and  941  may be achormat:bfl=53.6, working aperture 38 mm.  
      Referring now to  FIG. 92 , a still further embodiment of an illumination system  942  will be described. This system does not use a beamsplitter or dichroic mirror. Instead, both the source or LED  912  and detector  914  have direct line of sight to the optical analyte detecting member  938 . In this embodiment, multiple elements are combined into a single housing. For example, lens  943 , lens  944 , and filter  945  are combined while lens  946 , lens  947 , and filter  948  are also combined.  
      Referring now to  FIG. 93 , a cross-section of a system similar to that of  FIG. 89  is shown in a housing  950 . LED  912  sends light to mirror  919  to a light path  951  to cells  924  on a surface of the disc. A finger access  952  allows a sample to be obtained and flow along a fluid pathway  953  to be analyzed. A processor  954  may be coupled to detector  914  to analyze the results.  
      Referring now to  FIG. 94 , a cross-section of a system similar to that of  FIG. 90  will be further described. This shows a cartridge  929  used with a driver  882 . This allows for a radial design where the penetrating members extend radially outward as indicated by arrow  955 . The driver  882  may have a coupler portion that reciprocates as indicated by arrow  956 .  FIGS. 95 and 96  provide further views of a system similar to that of  FIG. 89 . The embodiment of  FIGS. 95 and 96  may include additional lenses or filters as may be useful to refine energy detection.  
      Referring now to  FIG. 97 , the area of interest is the velocity profile  1000  while the lancet is cutting through the skin layers in the finger until it reaches a predetermined depth. More specifically, variation of lancet velocity through different phases of the inbound trajectory is shown in  FIG. 97 . In this embodiment, Phase I corresponds to the stratum corneum, phase II to the epidermis and phase III to the dermis. At each phase (and during the phase), the options are to maintain current velocity, increase current velocity or decrease current velocity. Based on the thickness of the stratum corneum, velocity could be monitored and changed in this embodiment at 9 points in the stratum corneum, 6 points in the epidermis, and 29 points in the dermis using the four edge detection algorithm and the 360 strips per inch encoder strip. It should be noted that although the embodiment of the driver discussed herein produces the previously discussed number of monitoring points for a given displacement, other driver and position sensor embodiments may be used that would give higher or lower resolution.  
      For the purposes of the present discussion for this nonlimiting example, the skin is viewed as having three distinct regions or tissue layers: the stratum corneum SC (Phase I), the epidermis E (Phase II) and the dermis D (Phase III). In one embodiment, the lancet or penetrating member  10  is accelerated to a first desired velocity. This velocity may be predetermined or it may be calculated by the processor during actuation. The processor is also used to control the lancet velocity in tissue. At this velocity, the lancet  10  will impact the skin and initiate cutting through the stratum corneum. The stratum corneum is hard, hence in this embodiment, maximum velocity of the penetrating member  10  may be employed to efficiently cut through this layer, and this velocity may be maintained constant until the lancet passes through the layer. Power will likely need to be applied to the lancet drive  12  while the lancet is cutting through the stratum corneum in order to maintain the first velocity. Average stratum corneum thickness is about 225 μm. Using a four-edge detection algorithm for the position sensor  14  of this embodiment, the opportunity to verify and feed back velocity information can be carried out 225/17 or roughly 13 points. In another embodiment accelerating through the stratum corneum following impact may improve cutting efficiency. Acceleration may be possible if the lancet has not reached its target or desired velocity before impact.  FIG. 4  shows the result of increasing ((a) arrows, maintaining ((b) arrows) or reducing ((c) arrows) velocity on the lancet trajectory for each of the tissue layers.  
      On reaching the epidermis E (Phase II), an embodiment of a method may decrease the velocity ((c) arrows) from the first velocity so that tissue compression is reduced in this second tissue layer. Thus the lancet  10 , in this nonlimiting example, may have a second desired velocity that is less than the first velocity. The reduced speed in the second tissue layer may reduce the pain experienced by the mechano receptor nerve cells in the dermal layer (third tissue layer). In the absence of tissue compression effects on the dermal layer, however, lancet velocity may be kept constant for efficient cutting (i.e. second velocity may be maintained the same as the first velocity). In another embodiment, velocity may be increased in the second tissue layer from the first velocity.  
      In Phase III, the lancet or penetrating member  10  may reach the blood vessels and cut them to yield blood. The innervation of this third tissue layer and hence pain perception during lancing could be easily affected by the velocity profile chosen. In one embodiment, a third desired velocity may be chosen. The velocity may be chosen to minimize nerve stimulation while maintaining cutting efficiency. One embodiment would involve reducing velocity from the second velocity to minimize pain, and may increase it just before the blood vessels to be cut. The number of velocity measurement steps possible for the position sensor described above in the dermis is approximately 58. The user would determine the best velocity/cutting profile by usage. The profile with the least amount of pain on lancing, yielding a successful blood sample would be programmable into the device.  
      Currently users optimize depth settings on mechanical launchers by testing various settings and through usage, settle on a desired setting based on lancing comfort. Embodiments of the device and methods discussed herein provide a variety of velocity profiles ( FIG. 97 ), which can be optimized by the user for controlled lancing, and may include: controlling the cutting speed of a lancet with the lancet within the skin; adjusting the velocity profile of the lancet while the lancet is in the skin based upon the composition of the skin layers; lancing according to precise regional velocity profiles based on variation in cell type from the surface of the skin down through the epidermis and dermis; lancing at a desired velocity through any tissue layer and varying the velocity for each layer. This may include maximum velocity through the stratum corneum, mediation of velocity through epidermis to minimize shock waves to pain sensors in dermis, and mediation of velocity through dermis for efficient cutting of blood vessels without stimulating pain receptors. Additional details may be found in commonly assigned, co-pending U.S. patent application Ser. No. 10/420,535 (Attorney Docket No. 38187-2664) filed Apr. 21, 2003, included herein by reference.  
      Referring now to  FIG. 98 , a still further embodiment of an actuator according to the present invention will now be described. The present invention relates to an actuator  1010  that will launch a lancet or penetrating member  1020  into skin or an anatomical feature in a controlled manner so as to produce a small drop of blood or body fluid while minimizing patient discomfort. As a nonlimiting example, energy stored in a compressed spring, gas, or other actuation technique is released to actuate a lancet  1020 . Through the use of processor  1012 , the motion of the lancet or penetrating member  1020  is controlled by an iron-loaded fluid  1022  that changes viscosity in response to an imposed magnetic field. A motor or other device (not shown) may be used to control the retraction rate of the lancet  1020  from the skin or other targeted anatomical feature. It should be understood, of course, that other magnetically controllable fluid as known to those skilled in the art may also be used.  
       FIG. 98  documents the concept of using a magnetic fluid to control the action of a mechanical spring. In the embodiment of  FIG. 98 , energy is stored in the compressed spring and released at the time of actuation. As previously discussed, other actuators besides the compressed spring may also be used without departing from the spirit of the present invention. The motion of the lancet is controlled by means of an electromagnet that is arranged to produce a magnetic field in a fluid consisting of fine iron particles suspended in oil, silicone fluid, or other medium. When a magnetic field is imposed on the fluid, the iron particles align with the field, and resist motion. Fluid firmness increases with field strength. A suitable fluid can be purchased as MRF-132AD Rheonetic Fluid from Lord Corporation (888) 811-5673.  
       FIG. 99  provide details about launching and resetting the actuator for the present embodiment. A firing catch  1030  is shown to hold the spring  1010  in a cocked position prior to firing. An optically reflective member such as a flag  1032  is shown attached to the lancet coupler  1034  to provide position feedback through an optical position transducer. In some embodiments, the flag  1032  may be attached to a drive shaft (not shown). This feedback allows a processor  1012  to modulate the current to the electromagnetic coil or other magnetic field generator as known to one skilled in the art, to control the actuation profile of the lancet. A disc  1036  is shown attached to the penetrating member coupler  1034  and the disc is submerged in the rheonetic fluid. Suitable seals may be used to contain the fluid while allowing the shaft  1038  to pass through the dashpot chamber. In some embodiments, the disc  1036  is mounted about shaft  1040  and the entire dashpot chamber is also mounted about a portion of the shaft  1040 . A motor  1042 , or other retraction device is shown to move the dashpot and carry the drive shaft back to the cocked position. The motor then resets the dashpot to the desired stop position, and the actuation cycle is ready to repeat.  
      One advantage of this design is that each actuator can be matched to a portion of the actuation cycle. Rapid energy release is provided by the spring  1010  to bring the lancet or penetrating member  1020  up to speed. In one embodiment, excess energy stored in the spring allows the actuator  1010  to maintain the desired lancet speed regardless of skin or tissue consistency. The rheonetic fluid  1022  in the dashpot, controlled by the electromagnet, dissipates the excess energy from the spring  1010 . A DC reset motor  1042  can be driven at variable speeds by controlling the motor drive current. By this means, the retraction speed of the lancet can be controlled.  
      Another advantage of this present embodiment is that power consumption is reduced through the use of a small DC motor instead of a solenoid. The motor draws energy from a battery at a much lower rate and over a longer time, resulting in more efficient battery use.  
      In another aspect, the present embodiment provides a device for storing and rapidly releasing energy. The device controls the release of stored energy to control motion, controls the release of energy to provide a low impact stop, controls the storage of energy to control retraction motion, and stores energy for rapid release at the start of the next cycle.  
       FIG. 100  shows that embodiments of the lancet actuators of  FIGS. 98 and 99  may be configured for use with a radial cartridge  1050  having a plurality of penetrating members  1020 . Accordingly, these launchers may be coupled with single use or multiple use lancing devices. As a nonlimiting example, these devices may be used with a cartridge  500 .  
       FIG. 101  shows a more detailed view of one embodiment of an electromagnetic field generator  1052  coupled to a power source  1054  controlled by a processor  1012 .  
       FIG. 102  shows a still further embodiment similar to that shown in  FIG. 99 . This embodiment includes an actuator  1010  (shown in this nonlimiting example to be a spring), a disc  1036  coaxially mounted about a shaft  1040  in a ferrofluid  1022 , and a flag  1032  for monitoring lancet or penetrating member position. The launch device of  FIG. 102  may also be adapted for use with a radial cartridge (shown in phantom) having a plurality of penetrating members  1020  which may be coupled to the coupler  1034 .  
      Referring still to  FIG. 102 , energy is stored in the compressed spring used as actuator  1010  and is released at the time of actuation. In this embodiment, the motion of the penetrating member  1020  is controlled by an electromagnet  1052  that is arranged to produce a magnetic field in a fluid consisting of fine iron particles or other material suspended in but not limited to oil, silicone fluid, or other medium. When a magnetic field is imposed on the fluid, the iron particles align with the field, and resist motion. Fluid firmness increases with field strength. Such fluid can be purchased as MRF-132AD Rheonetic Fluid from Lord Corporation (888) 811-5673. A flag is shown attached to the drive shaft to provide position feedback through an optical position transducer. This feedback allows a processor to modulate the current to the electromagnetic coil to control the actuation profile of the lancet. A disc is shown attached to the drive shaft and submerged in the rheonetic fluid. Suitable seals are required to contain the fluid while allowing the shaft to pass through the dashpot chamber. A motor, or other driving device is shown to move the dashpot and carry the drive shaft back to the cocked position. The motor then resets the dashpot to the desired stop position, and the actuation cycle is ready to repeat. The advantage of this design is that each actuator may be matched to a portion of the actuation cycle. Rapid energy release is provided by the spring to bring the lancet up to speed. Excess energy stored in the spring allows the actuator to maintain the desired lancet speed regardless of skin consistency. The rheonetic fluid in the dashpot, controlled by the electromagnet, dissipates the excess energy from the spring. Of course, other dashpots or dampers as disclosed herein or as known to one of skill in the art may also be used. In one embodiment, a DC reset motor can be driven at variable speeds by controlling the motor drive current. By this motor, the retraction speed of the penetrating member  1020  can be controlled. A second advantage of this invention is that power consumption is reduced through the use of a small DC motor instead of a solenoid. The motor draws energy from a battery at a much lower rate and over a longer time, resulting in more efficient battery use. This hybrid device could also be configured to yield a “smart braking” pattern so that residual pain is minimized.  
      Referring now to  FIGS. 103A  to  103 E, a still further embodiment of a lancing apparatus relates to the spring actuation of a lancet to pierce the skin of a finger to produce a drop of blood for analysis. Blood yield may be increased by causing the lancet to dwell at the end of its stroke, and then retract at a slower rate.  
      As seen in  FIG. 103A , one embodiment of a simple lancet launcher  1060  comprises a compressed spring  1062  driving a moving mass  1064  that is attached to a lancet or penetrating member  1020  that pierces the skin or a targeted anatomical feature. When released (as seen in  FIG. 103B ), the spring  1062  accelerates the mass  1064  to a maximum speed at, or near, the point of contact between the lancet and skin. As the penetrating member  1020  pierces the skin or anatomical feature, the drive spring  1062  is extended and begins to slow the penetrating member  1020  ( FIG. 103C ). The lancet penetration depth is set approximately by providing an adjustable mechanical stop  1066  for the moving mass. As soon as the mass and lancet are stopped ( FIG. 103D ), the actuation spring  1062 , which is extended by the momentum of the mass, begins to withdraw the lancet.  
      In some embodiments, electronic actuation methods can delay the start of the retraction, providing a dwell of the penetrating member  1020  in the skin or tissue to allow some visco-elastic setting of the skin and promoting blood yield. Electronic actuators can also withdraw the lancet slowly to allow the blood to fill the wound channel, also promoting blood yield.  
      One economical solution to the lancet dwell requirement is to detach the drive spring  1062  from the actuator housing, preventing extension of the spring. As illustrated in  FIG. 103A , the drive spring  1062  accelerates the mass  1064  and lancet  1020  to speed, then travels with the mass as the lancet enters the skin. At impact of the mass  1064  with the travel stop  1066 , the spring  1062  continues to move until it is brought to a stop in a partially compressed state ( FIG. 103D ). The drive spring  1062  then rebounds and carries the mass  1064  and lancet  1020  with it ( FIG. 103E ). By adjusting the weight and spring constant of the drive spring, the length of dwell produced by the drive spring rebound can be varied. Some control over the retraction speed can be had through adjusting the weight and damping of the drive spring.  
      In a still further embodiment, adding a second, lower spring-constant, return spring  1070  can provide further control over the Detraction speed. This return spring or return springs  1070  also insures that the penetrating member  1020  retracts into the actuator housing instead of relying on the kinetic energy of the rebounding drive spring  1070 . As seen in  FIGS. 104A-104C , a variety of return devices may be used. In  FIG. 104A , the rebounding drive spring  1070  comprises an elastomeric element. In FIG.  104 B, two rebounding springs  1072  and  1074  are used. As seen in  FIG. 104C , a single spring  1076  may be coaxially mounted about the penetrating member  1020 . In one regard, the embodiments shown in  FIGS. 103-104  allow some control over the dwell and retraction speed of the lancet without resorting to expensive electronics. As a nonlimiting example, these embodiments of  FIGS. 103-104  may provide a dwell time for a lancet while piercing skin, a slower retraction rate during lancet withdrawal, and positive retraction of the lancet. The mechanism may be purely mechanical and less costly that electronic solutions.  
      Referring now to  FIG. 105 , a still further embodiment of an actuator according to the present invention will now be described. The embodiment in  FIG. 105  includes an inbound drive device  1080  and an outbound retraction device  1082 . As seen in the  FIG. 105 , the inbound drive device  1080  is in its forward position. The inbound drive device  1080  includes a plunger  1084  mounted with a spring  1086 . Pulling back on the plunger  1084  pulls back on the gripper block  1088  and compresses the spring  1086 . In this embodiment, a piston  1090  that slides into the damper  1092  also moves with the plunger  1084 . As the plunger  1084  is pulled back, it will come to a position (not shown) where the latch  1094  engages the gripper block  1088  and holds the plunger  1084  in a launch position. A button or other linking device may be coupled to the latch  1094  to allow a user to launch the penetrating member  1020 .  
      Moving the latch  1094  will release the gripper block  1088 , release the energy in the compressed spring  1086 , and drive the penetrating member  1020  towards the tissue or anatomical feature. It should be noted that in this embodiment, the open end  1096  of the damper  1092  is cone or funnel shaped. So initially, as the piston  1090  flies into the damper  1092 , it is flying there through air. As the piston  1090  is advanced, it runs into a narrowed portion of the damper  1092  that provides a close fit with the piston  1090 . In some embodiments, there may be an interference fit between the piston  1090  and the narrowed portion of the damper  1092 . In other embodiments, elastomeric material, other damping material, damping structure, or any combination of any of these elements may be used to provide a desired deceleration velocity profile. In this nonlimiting example, the damper  1092  provides variable damping as it allows the gripper block  1088  to be accelerated to its terminal velocity, driving the penetrating member  1020  at this high velocity, before encountering the damper  1092 . As the piston travels further into the damper, the damping factor may increase and provide further deceleration to the gripper block  1088 , thus also decelerating the penetrating member  1020 . In one embodiment, the gripper block  1088  slows to near a complete stop prior to encountering the hard stop  1098  on the carrier  1100 . In some embodiments, the hard stop  1098  may be covered with an elastomeric material, other damping material, damping structure, or any combination of any of these elements to provide a controlled stop of the gripper block.  
      Referring still to the embodiment of  FIG. 105 , the outbound retraction device  1082  may use a motor  1102 , or motor/gear box combination, to turn a screw  1104  and retract carrier  1100  housing the inbound drive device  1080 . A switch  1106  positioned at the stop or some other sensor device may be used to indicate when the inbound stroke is completed. In other embodiments, the motor  1102  or motor/gear box combination may be activated prior to the gripper block  1088  impacting the stop or prior to the gripper block  1088  coming to a complete stop. In such an embodiment, a sensor (not shown) may be positioned at a location prior to the gripper block  1088  reaching the stop  1098  and activate the motor  1102 . This may provide a further method for decelerating or braking the gripper block  1088 . In some embodiments, retraction by the outbound device  1082  may be delayed for a selectable amount of time such as, but not limited to, 1-200 ms to allow the penetrating member to come to rest in the tissue. In some further embodiments, retraction by the outbound device  1082  may be initiated for a selectable distance such as, but not limited to, about 20-50 microns based on how far the screw  1104  pulls back on carrier  1126 , and then stopped. It should be understood of course, that other distances such as about 50-75 microns, 75-100 microns, 100-125 microns may also be selected. This may be also used to minimize oscillation of the penetrating member  1020  against the tissue by withdrawing the penetrating member a small amount while the penetrating member  1020  is coming to rest against the stop  1096 . After the penetrating member  1020  has come to a stop, it may be held for a selectable amount of time, such as but not limited to 1-200 ms and then withdrawn, or in some embodiments, it may be withdrawn without a delay period. All of the above elements may be coupled to a chassis  1108 .  
      The depth of penetration by the penetrating member  1020  may also be determined by using the screw  1104  to control the position of the carrier  1126 . This controls depth since the protrusion distance by the penetrating member  1020  from the carrier  1126  is substantially constant. Thus by varying the position of the carrier  1126  in this embodiment, the penetration depth of the member  1020  relative to the front end  1127  is selectable. The position of the carrier  1126  may be selectable before each lancing event. The position of carrier  1126  may be determined by the user. The position of carrier  1126  may also be determined by a processor (not shown) which may track the penetration depth of previous lancing events and match it with some other variable such as but not limited to pain feedback number from the user, spontaneous blood generation, user hydration, or any other variable as described in commonly assigned, copending U.S. patent application Ser. No. 10/335,215 (Attorney Docket No. 38187-2634) filed Dec. 31, 2002. The screw  1104  may be controlled to provide varied depth control with resolution such as, but not limited to, about 1-5 microns, about 5-20 microns, other distance per adjustment. In some embodiments, this motor may be a stepper motor. In other embodiments, it may be an actuator such as but not limited to a pneumatic actuator, electric motor, or device with a position sensor to provide feedback as to carrier position.  
      Referring now to FIGS.  106  to  109  show a still further embodiment of a device having an inbound drive device  1110  and an outbound retraction device  1112 . Referring now the configuration shown in  FIG. 106 , the inbound drive device  1110  may include a spring  1086  coupled to a gripper block  1088 . A plunger  1114  is provided for use with a damper  1116  mounted concentrically about the shaft of the plunger. A latch  1094  with a flag portion  1118  is used to hold the gripper block  1088  in a launch position with the spring  1086  compressed. As seen in  FIG. 106 , the penetrating member  1020  may be guided by a front bearing  1120  and a rear bearing  1122 . It should be understood, that some embodiments may use one bearing, while other embodiments, may use two or more bearings. The type of clearance and support provided by the bearing may also be selectable. As a nonlimiting example, the bearings  1120  and  1122  may be structures with openings therethrough and have side-to-side clearance from about 20-40 microns and a vertical clearance from about 40-60 microns. Other embodiments may have greater clearances such as, but not limited to, about 60-100 microns, about 100-300 microns, or the like.  
      Referring now to  FIG. 107 , the device is now shown in a fired configuration with the penetrating member  1020  positioned fully forward. As seen, the gripper block  1088  or penetrating member coupler is now resting against the stop  1126 . Prior to the gripper block  1088  coming to a rest, the damper  1116  (shown more clearly in  FIG. 110 ) will engage the plunger  1114  to slow the gripper block  1088  prior to the block coming to rest.  
      Referring now to  FIG. 108 , the device is now shown with the plunger  1116  and gripper block  1088  in a fired configuration. However, the entire carrier  1130  having the gripper block  1088  and plunger  1116  is retracted in the direction indicated by arrow  1132 . As the carrier  1130  is drawn into the position shown in  FIG. 108 , the reset latch  1134  coupled to the chassis  1136  will lock into position against the gripper block  1088 . With the reset latch  1134  in this position, the spring  1086  can be compressed and the gripper block  1088  moved back into its launch position by moving the carrier  1126  forward as shown in  FIG. 109 .  
      Referring now to  FIG. 109 , carrier  1130  is advanced as indicated by arrow  1140 . As the carrier  1130  is advanced by the screw  1104 , the latch  1094  will ride over the gripper block  1088  and then drop into place as shown in  FIG. 109 . The position in  FIG. 109  shows the latch  1094  locked against the gripper block  1088 . A flag  1142  or cam surface offset to the side of the latch  1094  will engage a flag  1144  or cam surface on the reset latch  1134 . This moves the reset latch  1134  downward, releasing the latch from its locked position against the gripper block  1088 . Eventually, the reset latch  1134  will ride underneath the gripper block  1088  until the reset latch  1134  comes to rest in a position as shown in  FIG. 106 . In other embodiments, the reset latch  1124  may be coupled to a disposable such as a cartridge containing a plurality of penetrating members. In other embodiments, the reset latch  1134  may be attached to the same frame of reference as that of the motor  1102 . It may be part of the launcher and not the disposable. As a nonlimiting example, a cantilever beam may run from the chassis portion under the motor  1102  to hold the reset latch  1134  in position, as part of the launcher and not the disposable.  
       FIG. 110  shows an enlarged view of one embodiment of the damper  1116 . The damper  1116  may have a surface  1150  that is funnel shaped and a second surface  1152  configured to engage the widened portion  1154  of the plunger  1114 . It should be understood that the shape of the surface  1152  may be varied to create the desired velocity deceleration profile. As a nonlimiting example, the surface  1152  may define an interference fit with the plunger  1114 . In another embodiment, the damper  1116  is made of an elastomeric material and may function to provide more resistance against motion in one direction than another. This may be due in part to the elastomeric quality of the material which forms about the penetrating member during withdrawal from the damper  1116  to hold the penetrating member in. In some embodiments, the damper  1116  is cylindrical about plunger  1114 . In other embodiments, the damper  1116  may simply be two opposing surfaces  1152  and  1153 , without fully surround the shaft, that provides frictional resistance to the travel of the plunger  1114 .  
      Referring now to  FIG. 111 , a cross sectional view is shown of a spring-based penetrating member driver according to the present invention. In the embodiment of  FIG. 111 , a gripper block  1160  is used to engage a penetrating member  1020 . The gripper block  1160  is coupled to a shaft  1162  that has an enlarged end portion  1164 . A drive spring  1166  is provided about the shaft  1162  and compresses between the gripper block  1160  and the protrusion  1168 . In one embodiment, a second spring  1170  may also be provided and coupled to the shaft  1162  and the protrusion  1168 . In such an embodiment, the second spring  1170  may be configured as a return spring to urge the penetrating member  1020  back into the cartridge after the member has penetrated tissue. In some embodiments, a soft stop  1172  may also be used to assist the return of the penetrating member  1020  into the cartridge  1173 . A plunger  1174  may be pulled back in the direction indicated by arrow  1176  to place the gripper block  1160  and the penetrating member  1020  in a launch configuration. Release of trigger  1178  will cause the penetrating member  1020  to launch.  
      Referring now to  FIG. 112 , it shown that in one embodiment where the gripper block extends into the cartridge  1173 , the launcher and the cartridge  1173  maybe vertically separated as indicated by arrow  1180  to allow the cartridge  1173  which may be but is not limited to a disc shape, to rotate to position an unused penetrating member into contact with the gripper block  1160 . Vertically separating the parts allows the cartridge  1173  to be rotated without the gripper block  1160  interfering. In other embodiments, the gripper block may be designed so that the penetrating member has a portion that extend upward to engage the gripper block. In still other embodiments, the separation between the cartridge and the launcher may be such that gripper block remains in the cartridge but travels in a radial groove and is lifted enough to allow an unused lancet to be rotated into position. Vertical separation as shown in  FIG. 112  may involve the user physically pulling the parts away from each other or using cam surfaces such as those shown in  FIG. 55A .  
      Referring now to  FIG. 113 , a still further embodiment is shown where a cartridge  1200  is shown in a cylindrical configuration. A penetrating member driver  1202  will be used to engage the penetrating members in the cartridge  1200 . As a nonlimiting example, the driver may be an electromechanical device, a mechanical, spring-based device, or other actuator as described herein. Each cartridge  1200  may be rotated clockwise or counterclockwise to position the penetrating members into active alignment with the driver  1202 . After each cartridge  1200  is ready to be disposed, it may be moved forward as indicated by arrow  1204  and ejected from the sampling device. Another cartridge  1206  shown in phantom may be move forward by techniques using, but not limited to, a stepper motor, mechanical slider, or gravity to replace the used cartridge  1200 .  FIG. 114  shows a still further embodiment wherein the penetrating member driver  1202  is positioned to be within the center opening of cartridge  1200  to engage each penetrating member. As a nonlimiting example, the cartridge  1200  may be advanced by a stepper motor (not shown) or a mechanical slider mechanism to position an unused penetrating member into alignment with the driver  1202 .  
      Referring now to  FIG. 115 , the number of penetrating members remaining in the cartridge  1210  may be determined using a variety of devices. The cartridge  1210  may have markings or notches  1212  detectable by device  1214  which will keep count of the number of penetrating members used. In other embodiments, a processor  1216  will track the number of actuations and use that number to determine the number of penetrating members that remain unused in the cartridge  1210 . In such a configuration, the processor  1216  may assume that a new cartridge  1210  will contain X number of penetrating members and each actuation will reduce the number of unused penetrating members. Each time a new cartridge  1210  is loaded, the processor will assume that there are a full X number penetrating members available. The processor  1216  may also be coupled to the device  1214  to determine when the cartridge  1210  is rotated.  FIG. 115  also shows in phantom that a display  1218  may also be included to show the number of penetrating members remaining or other applicable variables to spring-based penetrating member driver  1220  as disclosed in commonly assigned, copending U.S. patent application Ser. No. 10/10/335,215 (Attorney Docket No. 38187-2634) filed Dec. 31, 2002. The device may include a slider for rotating the cartridge  1210  as shown in  FIG. 56A  and/or buttons to adjust settings on the display. As seen in  FIG. 115 , a plunger  1222  (shown in phantom) may be extended to protrude outward from a rear portion of the housing. In some embodiment the driver or just the plunger  1222  may extend above a top surface of the housing as seen in  FIG. 116 .  
      Referring now to  FIGS. 117 and 118 , still further combinations of mechanical and electrical actuators are shown. In one embodiment,  FIG. 117  shows an electric driver  1230  for advancing a gripper block or coupler  1232  in the direction indicated by arrow  1234 . A spring  1236  will be extended when the gripper block  1232  is moved. The spring  1236  will provide the retraction force and draw the gripper block  1232  and attached penetrating member back. In this embodiment, the electric driver  1230  will be relaxed or turned off after actuation, thus allowing the spring  1236  to draw the gripper block  1232  back.  
       FIG. 118  shows another embodiment where, in the launch configuration, the spring  1236  is extended and the electric driver  1240  is in a forward position. From this forward position, the driver  1240  may advance the penetrating member  1020  into targeted tissue. After reaching desired depth, a trigger  1242  will release the driver  1240  and pull the entire driver  1240  and penetrating member  1020  in the direction indicated by arrow  1244 . In some embodiments, this withdrawal motion may occur prior to the electric driver finishing its forward stroke.  
      Referring now to  FIGS. 119 and 120 , further embodiments of the present invention are shown where the depth of penetration into tissue may be set, in part, using a front end apparatus  1250 . The front end apparatus  1250  is rotated as indicated by arrow  1252 . Rotation in either direction will adjust the vertical separation  1254 . This vertical separation  1254  will change how close tissue may be placed against the sampling device. The greater the vertical separation  1254 , the less the penetrating member will protrude outward, and the less the penetration depth.  FIG. 120  shows an embodiment where the front end apparatus  1250  is recessed. This front end apparatus  1250  may be used with any of the penetrating member drivers described herein.  
      Referring now to  FIG. 121 , a still further aspect of a drive mechanism according to the present invention will be described.  FIG. 121  shows a cam groove  1260  that is followed by penetrating member driver. As a nonlimiting example, the driver may be a spring based device. The driver has a protrusion or follower that will follow the path provided by the cam groove  1260  to provide a desired velocity profile. One known device which also uses a cam groove is disclosed in U.S. Pat. No. 5,318,584, fully incorporated herein by reference. The follower  1262  indicated by a circle will follow the groove downward on the inbound stroke portion  1264 . After reaching maximum penetration, the follower  1262  will travel along the return portion  1266 . This return portion will provide a slower return velocity as the groove  1260  is configured at a shallow slope that requires the follower  1262  to follow a longer path that may bring the follower around the backside of the cylinder as indicated by arrow  1268 . This profile can provide a fast-in, slow-out velocity profile desired by some embodiments of the present invention. As a nonlimiting example, the return velocity may be ½, ¼, or any other fraction, percentage or portion of the inbound velocity.  
      In yet another aspect of the present invention, the current engine functions as a variable reluctance device and may be composed of an electronic drive unit or solenoid, an optical position sensor and a mechanism to couple the whole to the lancet. As a nonlimiting example, the penetrating member actuator may comprise of 2×6800 mF capacitors, a CR 123A 3V lithium primary battery, and a 5-coil solenoid of 30G wire. In this embodiment, there is one circuit board, which contains a processor (MPS430) for controlling the user interface, and another processor (SX 28) controlling the drive coils. The penetrating member may be driven by a series of solenoid coils (of which currently there are five in this embodiment), which are enclosed in a coil pack and surround the coupler shaft proximally to the penetrating member. A magnetic bead or “slug” may be attached to the coupler shaft and is configured to slide within the axial lumen of the driver coils. The driver coils are made of windings of copper wire, such as but not limited to about 32 gauge. The coils or “solenoids” drive the penetrating member using either magnetic attraction or repulsion of the slug.  
      Several possibilities exist for modification of the current solenoid drive. The specific advantages to be achieved are a reduction in size, and increase in efficiency, thus reducing power consumption requirements during the lancing process.  
      In one embodiment of the solenoid according to the present invention, a five-coil configuration was conceived because of a desired stroke distance of 8 mm determined from a displacement range needed to cover the sum of thick stratum corneum (up to 600 mm), tenting of about 1 mm or more and a maximum penetration of up to about 3.5 mm and acceleration distance enough to reach about 10 m/s. Stroke may be specified as the total displacement from one end of travel to the other end, or as a plus/minus (±) displacement from mid-stroke reference. Since these experiments were carried out it has been determined through patient testing in the lab that shallow lancing to about 1 mm may be sufficient to obtain the volumes of blood required to fill a sample chamber of 0.5 μl or less. Stroke distance, in such an embodiment, can therefore be reduced to (maximum tenting+depth+thickest stratum corneum=1 mm+1 mm+0.6 mm) 2.6 mm without consequence. This could reduce the number of coils in the system, reducing the size of the device and therefore lowering cost. It does require a slightly “fatter” set of coils since more turns may be used to maintain the drive power as well as a change in the slug size (longer) to reach the new spacing distance, but overall size should decrease.  
      In another embodiment of the solenoid, the flat coil embodiment was initially proposed as the first approach for driving the lancet electronically. In one embodiment, it uses a metal flag be attached to the penetrating member shaft to drive the lancet rather than a metal “slug”. This is somewhat disadvantageous to using bare penetrating members. The motivation for the flat coil configuration was miniaturization of the driver so as to fit in to a handheld glucose spot-monitoring device. Manufacturing of the coils can be by multi-layer printed circuit board (PCB) so it is straightforward. Such an embodiment is shown in commonly assigned, copending U.S. patent application Ser. No. 38187-2551.  
      In yet another embodiment of the solenoid, the multi-coil penetrating member driver with programmable excitation of the various energizing coils acting on a movable soft-iron “slug” works by timing the excitation of the various coils to provide motion in the desired direction. In some known configurations, there may be a series of stable “dead points” where the slug remains stationary unless the local coil is de-energized and the next coil is energized. This can create an inefficient “bumpy” force profile. The “rail-gun” approach provides a coil configuration for continuous (as opposed to step-wise) acceleration of the magnetic slug. It creates the required inhomogeneous magnet field to propel the slug and the attached penetrating member at a progressively increasing speed towards the target. At no point does the magnetic field of the coil oppose the desired motion of the slug. It facilitates the “fast entry-delay-slow retraction” mode of operation for minimum pain and maximum blood recovery. The coil could be wound with an increasing number of turns from the start point to the end point creating the required non-uniform magnetic field profile. A second coil could be wound in the remaining “free” space with increasing turns from the insertion point to the fully retracted point to implement retraction of the penetrating member, preferably at slow speed, using a weaker current feed. This economizes on electric drive power demand and uses the available space to the best advantage. Any desired time-dependent-profile could be achieved with spatially uniform winding geometry and a programmable time-dependent current feed with current increasing with time for insertion, but decreasing with time for retraction  
      The excitation coils may also be divided into a set of adjacent smaller coils fed with increasing currents from start point to end point, either according to position or as an increasing function of time. Continuous acceleration (as opposed to a step-wise drive with separate coils in the prior-art multi-coil device) may favor long slim coil geometry. One practical advantage is simplicity: in the basic embodiment no electronic control circuitry is required, just a simple on-off current switching control. However it allows electronic control to be added to determine penetration depth, using appropriate depth sensing and feedback. A fail-safe feature would be to feed the retraction coil with a weak continuous current to ensure that the penetrating member is returned to the start position (fill retraction). The soft-iron slug attached to the penetrating member may be replaced by a small permanent magnet attached to the penetrating member. Additional disclosure can be found in commonly assigned copending U.S. patent application Attorney Docket No. 38187-2551, incorporated herein by reference.  
      In another embodiment, slug shaping is based on the goal of increasing the force or efficiency of the coils by sculpting or changing the profile of the slug. The chisel point slug also fits in this category. The net result may be to reduce the size of the coil driver.  
      In one other embodiment, having two slugs in the field rather than one might increase the sensitivity to position and would require half of the energy. In addition large variations in force could be avoided making the control system more predictable and stable.  
      In yet another embodiment using a high voltage drive, this is a size reduction play by substituting the two-capacitor drive with a single smaller capacitor. The rationale for the dual capacitor drive is that the resistance drops for the two capacitors in parallel and the circulating currents in the coils should be reduced. Substitution of a single capacitor will result in an increase in resistance and hence the current requirement goes up and therefore there is a loss of efficiency of charge storage because of the increase in the voltage drop.  
      In a further aspect of the present invention, a mechanical inbound/electric withdrawal configuration may be used for penetrating member actuation and withdrawal.  FIG. 122  shows such an embodiment. Cheap mechanical actuation such as spring or cam drives  1300  may be supplemented by electronic withdrawal device  1310  for slow out retraction of the penetrating member  1020 . All of the embodiments below can be hybridized with a mechanical spring or cam driven inbound actuation. The mechanical inbound drives  1300  may be used with a soft braking mechanism such as but not limited to a soft stop  1312  or any other damping device disclosed herein or known to one of skill in the art. In the embodiment shown in  FIG. 122 , the withdrawal device  1310  may be used to move the entire carrier  1314  having the mechanical inbound drive  1300 . The use of electric withdrawal of a penetrating member  1020  from the anatomical feature at velocity less than that on the inbound may be used to increase the likelihood spontaneous fluid generation from a wound created in the feature. These components may all be contained in a housing  1320  (shown in phantom) that may optionally include an adjustable front end  1322  for adjusting depth of penetrating member penetration.  
      Referring now to  FIG. 123 , the device  1310  is not coupled to the carrier  1314 . It maybe used to withdraw the spring launched penetrating member  1020  as indicated by arrow  1324 . This allows the spring device to be pulled back and in some embodiments, reset for the next lancing event. It should be understood that the soft stop  1312  may also be configured to be on both sides of the penetrating member as shown in  FIG. 122 .  
      In one embodiment of the present invention, a DC Gear motor may be used as the device  1310 . In an embodiment similar that shown in  FIG. 102 , spring actuation or dashpot can be used for the inbound and the spring stays compressed against the dashpot. The motor  1042  drags the dashpot back and compresses the spring on its way. It can even re-cock the spring. This is a small DC motor with a speed reducing gear head. The DC motor can drive a jackscrew such that the withdrawal can be achieved in small steps as required by switching the motor on and off (see  1042 ). Position feedback may be used for better control. These motors are cheap and mass manufactured for cameras, toys and therefore this would be a cost reduction play.  
      In yet another embodiment of the present invention, a stepper motor may also be used as the device  1310 . The stepper motor can replace the gear motor and tend to run at a lower speed. It can run open loop so that position feedback would not be required. These motors are precise and would give amore compact package and better control method. In yet another embodiment of the present invention, a inductive motor may be used. This was the very first concept investigated for driving the penetrating member due to its ability to move penetrating members at high speeds and large throw. Unfortunately it is not very efficient due hysteretic losses, and the control problem is complicated.  
      In yet another embodiment of the present invention, a nanomuscle may be used as device  1310 . Nanomuscle actuators are based on shape memory alloys, that, when heated, their crystalline structures change and this result in mechanical contraction. Current is passed through the alloys to heat them. They claim to be over five times more efficient than a DC micro actuator of the equivalent size, faster and lighter. In one embodiment, they are about the size of a paperclip and are capable of 1,000,000 actuations. There are also supposed to produce rated force over their entire trajectory and allow position, speed and force to be controlled. In one embodiment, the extent of the nanomuscle stroke is about 4.0 mm, which should be enough to cover shallow lancing depth for a range of skin types. For a higher displacement or throw, several nano-muscles could be placed in series, thus raising the cost. Power consumption in the nanomuscle actuator is much less on the retraction phase than the actuation phase, which is why these devices were suggested for penetrating member withdrawal.  
      In yet another embodiment of the present invention, a liquid magnetic coil may be used as device  1310 . Energy stored in a compressed spring, gas, or other means is released to actuate a penetrating member towards the skin or an anatomical feature. In one nonlimiting example, the velocity trajectory of the penetrating member is controlled by an iron-loaded fluid that changes viscosity in response to an imposed magnetic field. The current can be switched on when a desired slowing in the spring withdrawal (or inbound trajectory—see below for details and drawing) to produce a controlled withdrawal profile. The withdrawal profile could be computer controlled so that switching on the field occurs in a specified pattern to simulate the best profile.  
      In yet another embodiment of the present invention, a electromechanical hybrid may be used. As a nonlimiting example, cheap electronic drive for inbound (hybrid spring and magnetic fluid), combined with cheap electronic for withdrawal using the same hybrid design may be a way to design a cost effective device with performance requirements to achieve low pain and spontaneity. Alternatively a motor can be used to control the retraction rate of the penetrating member from the skin if it is more cost effective or performs better on the withdrawal phase. Many miniaturized motors tested have been deficient in either the inbound speed or the throw, so it may be that two different engine types will have to be contemplated to achieve the speed and throw of the current design.  
      In yet another embodiment of the present invention, a hybrid liquid magnetic coil may be used. A version of the hybrid electromechanical device for both actuation and retraction is shown below. The electromagnetic field generator  1052  is coupled to a power source  1054  controlled by a processor  1012 .  
      Some embodiments of the present invention may also be configured to use a mechanical inbound with slow mechanical withdrawal or outbound device. As a nonlimiting example similar to that used with a cassette player lid, a dashpot device and would be coupled with a spring. This is a WYSIWYG system, so withdrawal will be at a (uncontrolled) uniform rate. No user definable withdrawal profile is the disadvantage of this set up.  
      In another nonlimiting example, a wax or other material with high thermal coefficient of expansion could be heated. As it expands and displaces a piston, it is coupled to a mechanism to withdraw the penetrating member. Similar to nanomuscle in actuation by heating.  
      In a still further nonlimiting example, a piezo electric bending mechanism may be used. There are electromechanical transducers that possess high motion and voltage sensitivity. Generally in motor applications two piezoelectric sheets are bonded together, one layer expands laterally and the other layer contracts when an electric field is applied. The opposing strains result in a deflection, which is proportional to the applied voltage, generating a displacement at low levels of electrical drive.  
      In a still further nonlimiting example, a traction drive may be used. A spinning rubber tire running at constant speed driven by DC motor drives a flat plate in contact with its outer circumference to withdraw the penetrating member and compressing the actuation spring This can be used in the same manner to actuate as well as withdraw the device.  
       FIG. 124  shows a schematic view of a penetrating member driver  1350  where the drive may be, but is not limited to, a nanomuscle, a liquid magnetic coil actuation, a stepper motor, a micro-clutch device, and an inductive motor. The driver  1350  may be used to provide both inbound and outbound motion for the penetrating member  1020  attached to a coupler  1034 .  
      Referring now to  FIGS. 125 and 126 , embodiments of the present invention may comprise kits containing any of the penetrating member actuators  1430  disclosed herein. The kit may further include instructions for use IFU setting forth any of the methods described above. Optionally, the kit may further comprise a cartridge containing a plurality of penetrating members. The cartridge  1432  may be of any of the embodiments disclosed herein. Usually, the kit components will be packaged together in a pouch P or other conventional medical device packaging, such as a box, tray, tube, or the like. In many embodiments, the cartridge will be disposable. The cartridge  1432  may itself be contained in a separate pouch or container and then inserted into the container P. In some embodiments, the IFU may be printed on the container P. In a nonlimiting example, the container P may only contain an actuator  1430 , without the cartridge  1432 .  
      Referring now to  FIG. 125 , embodiments of the present invention may include kits that only include a cartridge  1432 . IFU may also be included. In some embodiments, a plurality of cartridges  1432  (shown in phantom) may be included. Any of the elements in these figures or other elements described in this application may be placed in the container P, singly or in any combination. It should also be understood that the cartridges maybe of any shape as disclosed herein and are not limited to disc shaped embodiments.  
      Referring now to  FIG. 126 , a still further embodiment according to the present invention will now be described.  FIG. 126  shows an embodiment of a sampling device  1448  having a plurality of penetrating members  1450  housing in a cartridge (not shown) in the housing  1452 . The penetrating members  1450  may be operatively coupled to a penetrating member driver  1454  to extend the penetrating member  1450  from a penetrating member exit  1456 . In this embodiment, a test strip  1460  may be extended outward from a opening  1462  in a housing  1464 . It should be understood that in some embodiments, the housing  1452  and housing  1464  may be integrated together into a single housing. In other embodiments, the housings  1452  and  1464  may be separate devices that are coupled together. They may rotate in the same direction or in some embodiments may rotate in opposite directions. The housing  1464  may have its own slider or actuator for extending the test strip  1460  out from the housing  1464 . The test strip may be of a type known to those of skill in the art for measuring analytes in a body fluid. One suitable device suitable for a housing  1464  is described in U.S. Pat. No. 5,854,074 to Charlton et al., fully incorporated herein by references for all purposes. Although not limited to the following, the penetrating member driver  1454  may be a spring based launcher or any of the driver or combination of drivers disclosed herein.  
       FIG. 127  shows that the device of  FIG. 126  may also be configured so that penetrating member  1450  is on top while the test strip  1460  is on the bottom (when held horizontally).  FIG. 128  shows that the device  1448  may be used in a vertical orientation.  FIG. 129  shows that the device  1448  may also be used in a horizontal orientation. As seen in  FIG. 129 , the test strip  1460  may be made of flexible material such as a polymer or other material as known to those of skill in the art. This may allow gravity to bend the strip  1460  as shown in  FIG. 129  to bring the strip closer to the wound W on the tissue. Although not limited to the following, some embodiments of the test strip  1460  may have a capillary channels, tubes or members to draw fluid into the test strip  1460 . Wicking members, wicking materials, or absorbent materials may also be used in other embodiments of the test strip or any of the above may be combined in any order on a test strip. In some embodiments, the test strip  1460  may be oriented to extend outward at a diagonal, relative to the penetrating member, so that the distal end of the strip  1460  will be brought closer to the wound created by the penetrating member.  
      Referring now to  FIG. 130 , one embodiment of a cartridge  1470  according to the present invention and suitable for use with device  1448 . The cartridge  1470  may be rotated as indicated by arrow  1472 . One suitable device suitable for cartridge  1470  is described in U.S. Pat. No. 5,854,074 to Charlton et al., fully incorporated herein by references for all purposes. In one embodiment, the test strip  1460  may be ejected from the sealed container area  1474  to engage fluid from the wound. After use, the test strip  1460  may be removed from the cartridge or it may be reinserted into the cartridge. In some embodiments, the test strip  1460  may be coupled to electrode leads  1476  which extend back to contact pads  1478  that allow an analysis device to receive signal from a test strip. In one embodiment, a penetrating member  1450  (shown in phantom in  FIG. 130 ) may be associated with each test strip  1460 . In some embodiments, the penetrating member  1450  may be in the same cartridge  1470  or in a separate cartridge in other embodiments. It should be understood that the cartridge  1470  may be modified to include the features of the device disclosed in U.S. Pat. No. 5,854,074 to Charlton et al. In other embodiments, the penetrating member  1451  may be aligned to one side or the other of container  1474 .  
      Referring now to  FIG. 131 , a still further embodiment of the present invention will now be described. A penetrating member  1480  is housed in a cavity  1482 . A sterility barrier  1484  is used to maintain the penetrating member  1480  and analyte detecting members  1486  in a sterile environment. In some embodiments, these analyte detecting members  1486  may be coupled to electrode leads to bring signals to an analyte measurement device. In still further embodiments, one or more fracturable seals  1487  (shown in phantom) may be included with the device.  
       FIG. 132  shows the cartridge  1478  with the sterility barrier pealed back revealing the analyte detecting members  1486  and the penetrating member  1480 . It should be understood that some embodiment may use only a single analyte detecting member  1486 . Others may use analyte detecting members  1486  that operate in the optical domain. The analyte detecting members  1486  may be individual elements as seen in  FIG. 132 . In other embodiments, analyte detecting members  1486  maybe circular in shape or other shape to take up the entire area  1488 , substantially encircling the penetrating member exit.  
      Referring now to  FIG. 133 , a still further embodiment of the present invention is shown. The cartridge  1500  includes a plurality of test strips  1502 . The test strips  1502  may be oriented as shown or may be configured as indicated by the test strip  1504  (shown in phantom). A second cartridge  1506  containing a plurality of penetrating members may be placed or lowered about the cartridge  1500 . In some embodiments, the cartridges  1500  and  1506  may be integrated together. The penetrating members in the cartridge  1506  may extend outward as indicated by arrows  1508 . In one embodiment, the penetrating members extend outward when they are in the active position and are operatively coupled to the penetrating member driver. The test strips may extend outward in substantially the same direction as the arrows  1508 . A suitable device for cartridge  1500  is shown in U.S. Pat. No. 5,510,266 to Bonner, fully incorporated herein by reference for all purposes.  
      Referring now to  FIG. 134 , yet another embodiment of the present invention is shown. A cartridge  1500  is shown having a plurality of test strips  1502 . In some embodiments, the test strip  1502  is raised so that the strip is brought near but is not pierced by the penetrating member. In other embodiments, the penetrating member  1450  may pierce the test strip  1502 . A housing (not shown) may be implemented hold these devices in the orientations shown.  
      Referring now to  FIG. 135 , a still further embodiment of a cartridge  1520  according to the present invention is shown. There are portions  1522  where a plurality of penetrating members  1524  are housed. A penetrating member coupler (not shown) may be moved as indicated by arrows  1526 . In another embodiment, the entire cartridge is rotated as indicated by arrow  1528 . After the cartridge  1520  has made one complete revolution, the penetrating member holder may be moved over one position as indicated by arrow  1526 . The entire cartridge  1520  is then rotated again through one revolution, before the penetrating member coupler is shifted one more position as indicated by arrow  1528 .  
      Referring now to  FIG. 136 , a still further embodiment is shown where a plurality of analyte detecting members  1502  are shown in a stack configuration. After each detecting member  1502  is used, it may be removed and a new one will be revealed. It may also be pushed up by a biasing member (not shown). The cartridge  1540  may be integrated with the cartridge  1452 . It may also be shaped to be similar to the shape of cartridge  1452 . Still further, a housing may be used to hold a cartridge  1540  in relation to the cartridge  1452 . A user interface  1542  may be coupled to the device. A processor  1544  may be coupled to the device. A position sensor  1546  may be incorporated with the device so that lancing performance and/or tracking of position of the driver (and thus the penetrating member) may be monitored. Any of the embodiments of the present invention may be modified to include these elements.  
      The present invention provides a multiple analyte detecting member solution for body fluid sampling. Specifically, some embodiments of the present invention provides a multiple analyte detecting member and multiple penetrating member solution to measuring analyte levels in the body. The invention may use a high density penetrating member design. It may use penetrating members of smaller size, such as but not limited to diameter or length, than known penetrating members. The device may be used for multiple lancing events without having to remove a disposable from the device. The invention may provide improved sensing capabilities. At least some of these and other objectives described herein will be met by embodiments of the present invention.  
      One embodiment of the present invention is directed at penetrating member actuation using a linear stepper motor. Specifically, the invention relates to electronic penetrating member actuation with novel motor concepts.  
      Stepping motors may be viewed as electric motors without commutators. Typically, all windings in the motor are part of the stator, and the rotor is either a permanent magnet or, in the case of variable reluctance motors, a toothed block of some magnetically soft material. All of the commutation may be handled externally by the motor controller, and typically, the motors and controllers are designed so that the motor may be held in any fixed position as well as being rotated one way or the other. Most steppers, as they are also known, can be stepped at audio frequencies, allowing them to spin quite quickly, and with an appropriate controller, they may be started and stopped “on a dime” at controlled orientations.  
      For some applications, there is a choice between using servomotors and stepping motors. Both types of motors offer similar opportunities for precise positioning, but they differ in a number of ways. Servomotors require analog feedback control systems of some type. Typically, this involves a potentiometer to provide feedback about the rotor position, and some mix of circuitry to drive a current through the motor inversely proportional to the difference between the desired position and the current position.  
      In making a choice between steppers and servos, a number of issues may be considered; which of these will matter depends on the application. For example, the repeatability of positioning done with a stepping motor depends on the geometry of the motor rotor, while the repeatability of positioning done with a servomotor generally depends on the stability of the potentiometer and other analog components in the feedback circuit.  
      Stepping motors can be used in simple open-loop control systems; these are generally adequate for systems that operate at low accelerations with static loads, but closed loop control may be essential for high accelerations, particularly if they involve variable loads. If a stepper in an open-loop control system is overtorqued, all knowledge of rotor position is lost and the system may be reinitialized; servomotors are not subject to this problem.  
      Stepping motors come in two varieties, permanent magnet and variable reluctance (there are also hybrid motors, which are indistinguishable from permanent magnet motors from the controller&#39;s point of view). See for detailed explanation of stepper motors: http://www.cs.uiowa.edu/˜jones/step/types.html  
      In a simple form, a linear voice coil actuator is a tubular coil of wire situated within a radially oriented magnetic field. The field is produced by permanent magnets embedded on the inside diameter of a ferromagnetic cylinder, arranged so that the magnets “facing’ the coil are all of the same polarity. An inner core of ferromagnetic material set along the axial centerline of the coil, joined at one end to the permanent magnet assembly, is used to complete the magnetic circuit. The force generated axially upon the coil when current flows through the coil will produce relative motion between the field assembly and the coil, provided the force is large enough to overcome friction, inertia, and any other forces from loads attached to the coil.  
      The cost of voice coil actuators is generally expected to be higher than that of the solenoid because of the need for magnets (all other materials expected to be comparable). The relatively large air gaps of the voice coil actuators (resulting from the presence of the coils in air) tend to increase the power consumption for a given force compared to a solenoid. The overall dimensions proposed are dictated by the amount of travel desired and the space allocated for the ampere-turns. It may be that the round linear voice coil actuator has the highest suitability of all voice coil actuator as it is linear in motion, and has low moving mass.  
       FIG. 137  shows a cross-section of a linear (moving coil) voice coil embodiment. In one embodiment, the voice coil has 64 turns in that 2 millimeter gap, at 30 gauge US. The magnet has a south pole against steel and the north pole is adjacent the steel central core. The flux lines cross straight through the steel central core and the steel casing. The flux lines then move radially away from the steel central core.  
       FIG. 138  shows another embodiment of the present invention.  FIG. 138  shows one embodiment of a linear stepper motor  2050  in a flattened out configuration. This present embodiment relates to using a linear stepper motor concept flattened out to drive a penetrating member or penetrating member. This is a moving magnet implementation. It should be understood that the present linear stepper motor device  2050  may be used for a variety of purposes in addition to driving a penetrating member or penetrating member.  
      In the embodiment of  FIG. 138 , four coils  2052 ,  2054 ,  2056 , and  2058  are aligned with a magnet  2060  passing through them. As a nonlimiting example, the coils may be interconnected such as  52  to  56  and  54  to  58 , and the current direction may be reversed in the pairs of coils. There is good control of the drive mechanism because of the four coils. Of course, other number of coils may also be used with the drive device and the current invention is not limited to four coil embodiments. In some embodiments, the stepper motor  2050  may have micro stepping capability. Micro stepping could be used as the motor  2050  could step ⅛ of a step and hold, and therefore the feedback circuit may be dropped altogether for positioning of the shaft  2062 . However, even without a position sensor, the motor  2050  may still use a processor (not shown) to control the positioning.  
      Normally, linear and rotary potentiometers may be used to sense position in servo systems utilizing voice coil technology. Other devices may be used when special considerations such as high resolution or space limitations preclude the use of potentiometers, as is the case for the present lancing device. Rotary feedback devices include optical encoders, resolvers, inductosyns, or RVDT&#39;s (rotary variable differential transformers). Linear feed-inductosyns, magneto-resistive sensors (contactless pots), or LVDT&#39;s (linear variable differential transformers) are also used. An LVDT system was initially proposed for encoding position on the present lancing device. The current penetrating member actuator uses an optical encoder, as this provides an off-the-shelf solution with high enough resolution for our needs.  
      Some embodiments of the present invention may increase the flux density through an increase in mass. There may be a limit to how large you would want to make the magnet to get enough flux density to achieve the acceleration desired for our lancing applications. The flux goes between the outer shell and the center magnet. The advantage is good control due to the microstepper qualities of the present device.  
      Referring to now to  FIG. 139 , a still further embodiment of the present invention will now be described. In this embodiment, the planar moving coil/voice coil driver  2080  implementation is shown. The present invention may be a planar voice coil configuration used to actuate the penetrating member. It should be understood of course that the voice coil driver  2080  may also be used for other purposes in addition to actuating the penetrating member or penetrating member. The embodiment shown in  FIG. 139  uses two magnets  2082  and  2084 . Other number of magnets (both fewer or more magnets) may be used of course. The size and shape of the magnet may also be altered. As a nonlimiting example, the magnets could be extended in length. The device  2080  may be simple to machine, however the amount of copper used in the coil  2086  is outside of the casing  2088  and magnetic field, so that the return path for the flux is also outside of the field. The copper is cheap but heavier than iron because it is more dense. This would be the conventional way to approach non-axis symmetric voice coil actuation design. This flattened moving coil voice coil implementation may be used for penetrating member actuation.  
      As seen in  FIG. 139 , the magnets  2082  and  2084  may be in one plane and the voice coil  2086  is sitting above it. The support structure has been moved out of the gap between the magnets and the top piece of steel. The shaft may be in a slot between the top piece of steel. This reduces the gap and increases the efficiency. In one embodiment, the design of this device may be non-symmetrical and this is not symmetrical about the axis of the drive shaft.  
      Referring to  FIG. 140 , a still further embodiment of an actuator  2100  will now be described. This embodiment uses a linear voice coil actuator  2100  having a flux concentrator. Taking a linear (moving coil) voice coil, the present invention shapes the core  2110  to act as a flux concentrator to double the flux density and therefore reduce the size of the coil. The core  2110  may be shaped and the outer casting may also be shaped to assist with flux concentration. In one embodiment, the size of the central core  2110  has been reduced from about 12×12 mm to 10 mm×6 mm ( FIG. 140 ). The central core  2110  may be made from a variety of materials include, but not limited to, steel.  
      Referring still to  FIG. 140 , one embodiment of the invention is to double the flux density through the coil  2102 . This may reduce the surface area of the central core  2110 , and therefore reducing the size of the coil and the former. As seen in  FIG. 140 , the core  2110  may have a funnel shaped configuration. Although not limited to the following, the core  2110  may also be shaped as a cone, pyramid, or other wide to narrow shape to concentrate the flux so that the coil may be of a reduced weight.  
      In one embodiment where the core  2110  is sized at 10 mm at one end and 6 mm at another end, the field is almost at saturation. Hence the moving mass has been minimized and the maximum force (flux density) is achieved. In this embodiment, the clearance around the back end of the magnet  2112  is to discourage the flux path from forming anywhere other than through the coil  2102 . The present embodiment may therefore flatter, reducing the width and should result in a smaller size. The aspect of this present invention is to maximizing the flux concentration through the coil by shaping the casing results in a smaller size device for the same efficiency. The shaping of the casing may also result in shaping of the central core  2110  to concentrate the flux through the coil.  
      As seen in the embodiment of  FIG. 140 , the device  2100  is designed to concentrate the flux in the minimum dimension of steel, iron, or other material used for the core. The mass of the coil  2102  is minimized. Flux density is much higher due in part to the shape of the core  2110 . As a nonlimiting example, the 6 mm diameter while having a 10 mm diameter at the wide end. Minimize the moving mass will provide improved acceleration. It would also make coil smaller. The present invention would increase flux density to maximize force. Through the same gap and everything else. The present invention may optimize flux in the moving area. Some embodiments of the present invention may also reduce concentration of flux at sharp corners.  
      In yet another embodiment of the present invention, a linear moving coil voice coil may be used as an actuator. In a linear moving coil configuration, the actuator consists of a cylindrical coil that is free to move axially in air gap. The air gap is formed between a cylindrical center pole and a permanent magnet that surrounds it. A soft iron shell houses both the magnet and the pole.  
      In another embodiment of the present invention, a flat voice coil may be used. In one embodiment, the flat voice coil design uses a flat coil between strong permanent magnets. The coil may be a wound coil on a plastic support frame or a multi-layer PC board design. The electronics should be simpler; the voice coil design goal is to operate the coil directly from the battery. In one embodiment, no DC-DC converter would be required to boost to the high voltage (which the present solenoid actuator requires). The charge storage on the capacitors is more efficient, and it does not require a high voltage drive. Hence there may be a lower electronics cost—since the DC-DC converter circuitry may be avoided in some instances. The voice coil should offer simpler microprocessor control, as it should be able to span the entire stroke of activation without switching from coil to coil as the movement progresses. Reversing the current in the coil reverses the direction of force.  
      In a still further embodiment, a rotary voice coil may be used. If one were to “flatten” the linear voice coil actuator from a round tube to a flat tube, then bend the two ends to form a planar arc; such as a sector of an annulus, one would have a rotary voice coil actuator. Its principle of operation and force generation is analogous to that of the linear counterpart. Rotary voice coils require that their motion be transferred to linear by some mechanical means resulting also in higher manufacturing cost and lower speeds due to the weight and complexity of the conversion mechanism. They are less energy efficient than circular designs but their advantage lies in the fact that only the dimensions of the magnetic path limit the throw distance.  
      In yet another embodiment, an unrolled rotary voice coil may be used. This is a multi-segmented coil and can be thought of as equivalent to the solenoid coil using a permanent magnet instead of a metal slug. The magnet can be formed. This is a size reduction play. However a large area is used to maintain the stroke and has a series of coils rather than a disk. The control problem becomes more complex but the subsections behave more linearly. In one embodiment, only one small coil is needed so the moving mass is smaller. The problem is that the device acts more as a very efficient brake since the flux lines end up being cut with both ends of the magnet. In some still further alternative embodiments, rotary or linear moving magnet voice coil may be used. A linear stepper motor with a moving magnet in a flattened configuration has been suggested.  
      In one aspect of the present invention, a linear stepper motor is described comprising a plurality of coils and a shaft slidably mounted through an opening through the plurality of coils. A magnet may be mounted about the shaft and at least one metallic core mounted about the shaft. In some embodiments, the plurality of coils may comprise of a first coil that is coupled to a third coil and a second coil that is coupled to a fourth coil. The shaft, magnet, and at least one metallic core may be slidably movable through the coils. The coils may be cylindrical in shape with an opening therethrough.  
      In another embodiment of the present invention, a voice coil device is provided that comprises at least one magnet located in a plane and not symmetric about a drive shaft. The device may include a movable coil mounted adjacent to the magnet and in a single plane, the coil is not symmetric about the drive shaft. A metallic shell may also be coupled to the magnets.  
      In a still further embodiment, a voice coil device is provided comprising a movable coil and a metallic core shaped to increase flux through the coil, wherein the coil is movable relative to the core, the core having a smaller transverse dimension in portions that travel through the coil and a larger transverse dimension for those portions outside the coil. An outer casing may be shaped to direct flux through the core passing through the coil. The shaft may be slidably mounted in the core. In some embodiments, an outer casing may be shaped to direct flux through the core passing through the coil.  
      As discussed above, tissue penetration devices which employ spring or cam driving methods have a symmetrical or nearly symmetrical actuation displacement and velocity profiles on the advancement and retraction of the penetrating member as shown in  FIGS. 141 and 142 . In most of the available penetrating member devices, once the launch is initiated, the stored energy determines the velocity profile until the energy is dissipated. Controlling impact, retraction velocity, and dwell time of the penetrating member within the tissue can be useful in order to achieve a high success rate while accommodating variations in skin properties and minimize pain. Advantages can be achieved by taking into account that tissue dwell time is related to the amount of skin deformation as the penetrating member tries to puncture the surface of the skin and variance in skin deformation from patient to patient based on skin hydration.  
      The ability to control velocity and depth of penetration can be achieved by use of a controllable force driver where feedback is an integral part of driver control. Such drivers can control either metal or polymeric penetrating members or any other type of tissue penetration element. The dynamic control of such a driver is illustrated in  FIG. 143  which illustrates an embodiment of a controlled displacement profile and  FIG. 144  which illustrates an embodiment of a the controlled velocity profile. These are compared to  FIGS. 141 and 142 , which illustrate embodiments of displacement and velocity profiles, respectively, of a harmonic spring/mass powered driver.  
      Reduced pain can be achieved by using impact velocities of greater than 2 m/s entry of a tissue penetrating element, such as a penetrating member, into tissue.  
      Retraction of the penetrating member at a low velocity following the sectioning of the venuole/capillary mesh allows the blood to flood the wound tract and flow freely to the surface, thus using the penetrating member to keep the channel open during retraction. Low-velocity retraction of the penetrating member near the wound flap prevents the wound flap from sealing off the channel. Thus, the ability to slow the penetrating member retraction directly contributes to increasing the success rate of obtaining blood. Increasing the sampling success rate to near 100% can be important to the combination of sampling and acquisition into an integrated sampling module such as an integrated glucose-sampling module, which incorporates a glucose test strip.  
       FIG. 145  shows an embodiment of the characteristic phases of penetrating member advancement and retraction on a graph of force versus time illustrating the force exerted by the penetrating member driver on the penetrating member to achieve the desired displacement and velocity profile. The characteristic phases are the penetrating member introduction phase A-C where the penetrating member is longitudinally advanced into the skin, the penetrating member rest phase D where the penetrating member terminates its longitudinal movement reaching its maximum depth and becoming relatively stationary, and the penetrating member retraction phase E-G where the penetrating member is longitudinally retracted out of the skin. The duration of the penetrating member retraction phase E-G is longer than the duration of the penetrating member introduction phase A-C, which in turn is longer than the duration of the penetrating member rest phase D.  
      The introduction phase further comprises a penetrating member launch phase prior to A when the penetrating member is longitudinally moving through air toward the skin, a tissue contact phase at the beginning of A when the distal end of the penetrating member makes initial contact with the skin, a tissue deformation phase A when the skin bends depending on its elastic properties which are related to hydration and thickness, a tissue lancing phase which comprises when the penetrating member hits the inflection point on the skin and begins to cut the skin B and the penetrating member continues cutting the skin C. The penetrating member rest phase D is the limit of the penetration of the penetrating member into the skin. Pain is reduced by minimizing the duration of the penetrating member introduction phase A-C so that there is a fast incision to a certain penetration depth regardless of the duration of the deformation phase A and inflection point cutting B which will vary from user to user. Success rate is increased by measuring the exact depth of penetration from inflection point B to the limit of penetration in the penetrating member rest phase D. This measurement allows the penetrating member to always, or at least reliably, hit the capillary beds which are a known distance underneath the surface of the skin.  
      The penetrating member retraction phase further comprises a primary retraction phase E when the skin pushes the penetrating member out of the wound tract, a secondary retraction phase F when the penetrating member starts to become dislodged and pulls in the opposite direction of the skin, and penetrating member exit phase G when the penetrating member becomes free of the skin. Primary retraction is the result of exerting a decreasing force to pull the penetrating member out of the skin as the penetrating member pulls away from the finger. Secondary retraction is the result of exerting a force in the opposite direction to dislodge the penetrating member. Control is necessary to keep the wound tract open as blood flows up the wound tract. Blood volume is increased by using a uniform velocity to retract the penetrating member during the penetrating member retraction phase E-G regardless of the force required for the primary retraction phase E or secondary retraction phase F, either of which may vary from user to user depending on the properties of the user&#39;s skin.  
       FIG. 146  shows another embodiment of displacement versus time profile of a penetrating member for a controlled penetrating member retraction.  FIG. 147  shows the velocity vs. time profile of the penetrating member for the controlled retraction of  FIG. 146 . The penetrating member driver controls penetrating member displacement and velocity at several steps in the lancing cycle, including when the penetrating member cuts the blood vessels to allow blood to pool  2130 , and as the penetrating member retracts, regulating the retraction rate to allow the blood to flood the wound tract while keeping the wound flap from sealing the channel  2132  to permit blood to exit the wound.  
      The tenting process and retrograde motion of the penetrating member during the lancing cycle is illustrated graphically in  FIG. 148  which shows both a velocity versus time graph and a position versus time graph of a penetrating member tip during a lancing cycle that includes elastic and inelastic tenting. In  FIG. 148 , from point  0  to point A, the penetrating member is being accelerated from the initialization position or zero position. From point A to point B, the penetrating member is in ballistic or coasting mode, with no additional power being delivered. At point B, the penetrating member tip contacts the tissue and begins to tent the skin until it reaches a displacement C. As the penetrating member tip approaches maximum displacement, braking force is applied to the penetrating member until the penetrating member comes to a stop at point D. The penetrating member then recoils in a retrograde direction during the settling phase of the lancing cycle indicated between D and E. Note that the magnitude of inelastic tenting indicated in  FIG. 148  is exaggerated for purposes of illustration.  
      The amount of inelastic tenting indicated by Z tends to be fairly consistent and small compared to the magnitude of the elastic tenting. Generally, the amount of inelastic tenting Z can be about 120 to about 140 microns. As the magnitude of the inelastic tenting has a fairly constant value and is small compared to the magnitude of the elastic tenting for most patients and skin types, the value for the total amount of tenting for the penetration stroke of the penetrating member is effectively equal to the rearward displacement of the penetrating member during the settling phase as measured by the processor  193  plus a predetermined value for the inelastic recoil, such as 130 microns. Inelastic recoil for some embodiments can be about 100 to about 200 microns. The ability to measure the magnitude of skin tenting for a patient is important to controlling the depth of penetration of the penetrating member tip as the skin is generally known to vary in elasticity and other parameters due to age, time of day, level of hydration, gender and pathological state.  
      This value for total tenting for the lancing cycle can then be used to determine the various characteristics of the patient&#39;s skin. Once a body of tenting data is obtained for a given patient, this data can be analyzed in order to predict the total penetrating member displacement, from the point of skin contact, necessary for a successful lancing procedure. This enables the tissue penetration device to achieve a high success rate and minimize pain for the user. A rolling average table can be used to collect and store the tenting data for a patient with a pointer to the last entry in the table. When a new entry is input, it can replace the entry at the pointer and the pointer advances to the next value. When an average is desired, all the values are added and the sum divided by the total number of entries by the processor  193 . Similar techniques involving exponential decay (multiply by 0.95, add 0.05 times current value, etc.) are also possible.  
      With regard to tenting of skin generally, some typical values relating to penetration depth are now discussed.  FIG. 149  shows a cross sectional view of the layers of the skin. In order to reliably obtain a useable sample of blood from the skin, it is desirable to have the penetrating member tip reach the venuolar plexus of the skin. The stratum corneum is typically about 0.1 to about 0.6 mm thick and the distance from the top of the dermis to the venuole plexus can be from about 0.3 to about 1.4 mm. Elastic tenting can have a magnitude of up to about 2 mm or so, specifically, about 0.2 to about 2.0 mm, with an average magnitude of about 1 mm. This means that the amount of penetrating member displacement necessary to overcome the tenting can have a magnitude greater than the thickness of skin necessary to penetrate in order to reach the venuolar plexus. The total penetrating member displacement from point of initial skin contact may have an average value of about 1.7 to about 2.1 mm. In some embodiments, penetration depth and maximum penetration depth may be about 0.5 mm to about 5 mm, specifically, about 1 mm to about 3 mm. In some embodiments, a maximum penetration depth of about 0.5 to about 3 mm is useful.  
      In some embodiments, the penetrating member is withdrawn with less force and a lower speed than the force and speed during the penetration portion of the operation cycle. Withdrawal speed of the penetrating member in some embodiments can be about 0.004 to about 0.5 m/s, specifically, about 0.006 to about 0.01 m/s. In other embodiments, useful withdrawal velocities can be about 0.001 to about 0.02 meters per second, specifically, about 0.001 to about 0.01 meters per second. For embodiments that use a relatively slow withdrawal velocity compared to the penetration velocity, the withdrawal velocity may up to about 0.02 meters per second. For such embodiments, a ratio of the average penetration velocity relative to the average withdrawal velocity can be about 100 to about 1000. In embodiments where a relatively slow withdrawal velocity is not important, a withdrawal velocity of about 2 to about 10 meters per second may be used.  
      Another example of an embodiment of a velocity profile for a penetrating member can be seen in  FIGS. 150 and 151 , which illustrates a penetrating member profile with a fast entry velocity and a slow withdrawal velocity.  FIG. 150  illustrates an embodiment of a lancing profile showing velocity of the penetrating member versus position. The lancing profile starts at zero time and position and shows acceleration of the penetrating member towards the tissue from the electromagnetic force generated from the electromagnetic driver. At point A, the power is shut off and the penetrating member begins to coast until it reaches the skin indicated by B at which point, the velocity begins to decrease. At point C, the penetrating member has reached maximum displacement and settles momentarily, typically for a time of about 8 milliseconds.  
      A retrograde withdrawal force is then imposed on the penetrating member by the controllable driver, which is controlled by the processor to maintain a withdrawal velocity of no more than about 0.006 to about 0.01 meters/second. The same cycle is illustrated in the velocity versus time plot of  FIG. 151  where the penetrating member is accelerated from the start point to point A. The penetrating member coasts from A to B where the penetrating member tip contacts tissue  233 . The penetrating member tip then penetrates the tissue and slows with braking force eventually applied as the maximum penetration depth is approached. The penetrating member is stopped and settling between C and D. At D, the withdrawal phase begins and the penetrating member is slowly withdrawn until it returns to the initialization point shown by E in  FIG. 151 . Note that retrograde recoil from elastic and inelastic tenting was not shown in the lancing profiles of  FIGS. 150 and 151  for purpose of illustration and clarity.  
      In another embodiment, the withdrawal phase may use a dual speed profile, with the slow 0.006 to 0.01 meter per second speed used until the penetrating member is withdrawn past the contact point with the tissue, then a faster speed of 0.01 to 1 meters per second may be used to shorten the complete cycle.  
      While the invention has been described and illustrated with reference to certain particular embodiments thereof, those skilled in the art will appreciate that various adaptations, changes, modifications, substitutions, deletions, or additions of procedures and protocols may be made without departing from the spirit and scope of the invention. For example, with any of the above embodiments, the location of the penetrating member drive device may be varied, relative to the penetrating members or the cartridge. With any of the above embodiments, the penetrating member tips may be uncovered during actuation (i.e. penetrating members do not pierce the penetrating member enclosure or protective foil during launch). With any of the above embodiments, the penetrating members may be a bare penetrating member during launch. With any of the above embodiments, the penetrating members may be bare penetrating members prior to launch as this may allow for significantly tighter densities of penetrating members. In some embodiments, the penetrating members may be bent, curved, textured, shaped, or otherwise treated at a proximal end or area to facilitate handling by an actuator. The penetrating member may be configured to have a notch or groove to facilitate coupling to a gripper. The notch or groove may be formed along an elongate portion of the penetrating member. With any of the above embodiments, the cavity may be on the bottom or the top of the cartridge, with the gripper on the other side. In some embodiments, analyte detecting members may be printed on the top, bottom, or side of the cavities. The front end of the cartridge maybe in contact with a user during lancing. The same driver may be used for advancing and retraction of the penetrating member. The penetrating member may have a diameters and length suitable for obtaining the blood volumes described herein. The penetrating member driver may also be in substantially the same plane as the cartridge. The driver may use a through hole or other opening to engage a proximal end of a penetrating member to actuate the penetrating member along a path into and out of the tissue.  
      Any of the features described in this application or any reference disclosed herein may be adapted for use with any embodiment of the present invention. For example, the devices of the present invention may also be combined for use with injection penetrating members or needles as described in commonly assigned, copending U.S. patent application Ser. No. 10/127,395 (Attorney Docket No. 38187-2551) filed Apr. 19, 2002. An analyte detecting member to detect the presence of foil may also be included in the lancing apparatus. For example, if a cavity has been used before, the foil or sterility barrier will be punched. The analyte detecting member can detect if the cavity is fresh or not based on the status of the barrier. It should be understood that in optional embodiments, the sterility barrier may be designed to pierce a sterility barrier of thickness that does not dull a tip of the penetrating member. The lancing apparatus may also use improved drive mechanisms. For example, a solenoid force generator may be improved to try to increase the amount of force the solenoid can generate for a given current. A solenoid for use with the present invention may have five coils and in the present embodiment the slug is roughly the size of two coils. One change is to increase the thickness of the outer metal shell or windings surround the coils. By increasing the thickness, the flux will also be increased. The slug may be split; two smaller slugs may also be used and offset by ½ of a coil pitch. This allows more slugs to be approaching a coil where it could be accelerated. This creates more events where a slug is approaching a coil, creating a more efficient system.  
      In another optional alternative embodiment, a gripper in the inner end of the protective cavity may hold the penetrating member during shipment and after use, eliminating the feature of using the foil, protective end, or other part to retain the used penetrating member. Some other advantages of the disclosed embodiments and features of additional embodiments include: same mechanism for transferring the used penetrating members to a storage area; a high number of penetrating members such as 25, 50, 75, 100, 500, or more penetrating members may be put on a disk or cartridge; molded body about a lancet becomes unnecessary; manufacturing of multiple penetrating member devices is simplified through the use of cartridges; handling is possible of bare rods metal wires, without any additional structural features, to actuate them into tissue; maintaining extreme (better than 50 micron-lateral- and better than 20 micron vertical) precision in guiding; and storage system for new and used penetrating members, with individual cavities/slots is provided. The housing of the lancing device may also be sized to be ergonomically pleasing. In one embodiment, the device has a width of about 56 mm, a length of about 105 mm and a thickness of about 15 mm. Additionally, some embodiments of the present invention may be used with non-electrical force generators or drive mechanism. For example, the punch device and methods for releasing the penetrating members from sterile enclosures could be adapted for use with spring based launchers. The gripper using a frictional coupling may also be adapted for use with other drive technologies.  
      Still further optional features may be included with the present invention. For example, with any of the above embodiments, the location of the penetrating member drive device may be varied, relative to the penetrating members or the cartridge. With any of the above embodiments, the penetrating member tips may be uncovered during actuation (i.e. penetrating members do not pierce the penetrating member enclosure or protective foil during launch). The penetrating members may be a bare penetrating member during launch. In some embodiments, the penetrating member may be a patent needle. The same driver may be used for advancing and retraction of the penetrating member. Different analyte detecting members detecting different ranges of glucose concentration, different analytes, or the like may be combined for use with each penetrating member. Non-potentiometric measurement techniques may also be used for analyte detection. For example, direct electron transfer of glucose oxidase molecules adsorbed onto carbon nanotube powder microelectrode may be used to measure glucose levels. In some embodiments, the analyte detecting members may formed to flush with the cartridge so that a “well” is not formed. In some other embodiments, the analyte detecting members may formed to be substantially flush (within 200 microns or 100 microns) with the cartridge surfaces. In all methods, nanoscopic wire growth can be carried out via chemical vapor deposition (CVD). In all of the embodiments of the invention, preferred nanoscopic wires may be nanotubes. Any method useful for depositing a glucose oxidase or other analyte detection material on a nanowire or nanotube may be used with the present invention. Additionally, for some embodiments, any of the cartridge shown above may be configured without any of the penetrating members, so that the cartridge is simply an analyte detecting device. Still further, the indexing of the cartridge may be such that adjacent cavities may not necessarily be used serially or sequentially. As a nonlimiting example, every second cavity may be used sequentially, which means that the cartridge will go through two rotations before every or substantially all of the cavities are used. As another nonlimiting example, a cavity that is 3 cavities away, 4 cavities away, or N cavities away may be the next one used. This may allow for greater separation between cavities containing penetrating members that were just used and a fresh penetrating member to be used next. It should be understood that the spring-based drivers shown in the present invention ( FIGS. 98-112 ) may be adapted for use with any of the cartridges shown herein such as, but not limited to, those shown in  FIGS. 61 and 62 . These spring-based drivers may also be paired with gripper blocks that are configured to penetrate into cartridges that fully seal penetrating member therein, in order engage those penetrating members. The start and end positions of the penetrating members may also be the same. The penetrating members may be parked in a holder before actuation, and in some embodiments, into a holder after actuation (as seen in cartridge  500  or any other cartridge herein). Embodiments of the present invention may also include guides which provide lateral constraints and/or vertical constraints about penetrating member. These constraints may be positioned about the shaft portions of the penetrating member. For any of the embodiments herein, they may be configured to provide the various velocity profiles described.  
      This application cross-references commonly assigned copending U.S. patent application Ser. No. 10/323,622 (Attorney Docket No. 38187-2606) filed Dec. 18, 2002; commonly assigned copending U.S. patent application Ser. No. 10/323,623 (Attorney Docket No. 38187-2607) filed Dec. 18, 2002; and commonly assigned copending U.S. patent application Ser. No. 10/323,624 (Attorney Docket No. 38187-2608) filed Dec. 18, 2002. This application is also related to commonly assigned copending U.S. patent application Ser. Nos. 10/335,142, 10/335,215, 10/335,258, 10/335,099, 10/335,219, 10/335,052, 10/335,073, 10/335,220, 10/335,252, 10/335,218, 10/335,211, 10/335,257, 10/335,217, 10/335,212, and 10/335,241, 10/335,183, (Attorney Docket Nos. 38187-2633 through 38187-2652) filed Dec. 31, 2002. This application is also a continuation-in-part of commonly assigned, copending U.S. patent application Ser. No. 10/425,815 (Attorney Docket No. 38187-2663) filed May 30, 2003. This application is a continuation-in-part of commonly assigned, copending U.S. patent application Ser. No. 10/323,622 (Attorney Docket No. 38187-2606) filed on Dec. 18, 2002, which is a continuation-in-part of commonly assigned, copending U.S. patent application Ser. No. 10/127,395 (Attorney Docket No. 38187-2551) filed Apr. 19, 2002. This application is also a continuation-in-part of commonly assigned, copending U.S. patent application Ser. No. 10/237,261 (Attorney Docket No. 38187-2595) filed Sep. 5, 2002. This application is further a continuation-in-part of commonly assigned, copending U.S. patent application Ser. No. 10/420,535 (Attorney Docket No. 38187-2664) filed Apr. 21, 2003. This application is further a continuation-in-part of commonly assigned, copending U.S. patent application Ser. No. 10/335,142 (Attorney Docket No. 38187-2633) filed Dec. 31, 2002. This application is further a continuation-in-part of commonly assigned, copending U.S. patent application Ser. No. 10/423,851 (Attorney Docket No. 38187-2657) filed Apr. 24, 2003. This application also claims the benefit of priority from commonly assigned, copending U.S. Provisional Patent Application Ser. No. 60/422,988 (Attorney Docket No. 38187-2601) filed Nov. 1, 2002; commonly assigned, copending U.S. Provisional Patent Application Ser. No. 60/424,429 (Attorney Docket No. 38187-2602) filed Nov. 6, 2002; and commonly assigned, copending U.S. Provisional Patent Application Ser. No. 60/424,429 (Attorney Docket No. 38187-2604) filed Nov. 20, 2002. All applications listed above are incorporated herein by reference for all purposes.  
      The publications discussed or cited herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. All publications mentioned herein are incorporated herein by reference to disclose and describe the structures and/or methods in connection with which the publications are cited.  
      Expected variations or differences in the results are contemplated in accordance with the objects and practices of the present invention. It is intended, therefore, that the invention be defined by the scope of the claims which follow and that such claims be interpreted as broadly as is reasonable.