Abstract:
A medical device, such as a Huber-type device, includes a structure that enhances operator safety by reducing the likelihood that a needle will accidentally injure an operator. In one embodiment, the device includes a collapsible structure that can move from a use position to a non-use position. The device includes first and second wing portions and a channel for covering the needle as it is extracted from the patient. The structure enables the operator to leverage applied pressure for a smooth removal of the needle into the device for safe disposal.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application is a Continuation-in-Part of and claims the benefit of U.S. patent application Ser. No. 10/242,976, filed Sep. 13, 2002, which is hereby incorporated by reference. 
     
    
     
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH  
         [0002]    Not Applicable.  
         FIELD OF THE INVENTION  
         [0003]    The present invention relates generally to medical devices and, more particularly, to medical devices having a needle for insertion into a patient.  
         BACKGROUND OF THE INVENTION  
         [0004]    Medical devices for injecting fluids into a patient are well known in the art. One such type of device is generally referred to as implanted ports, which can be implanted subcutaneously in a patient. Various types of ports can be used to provide access to the peritoneal cavity, as well as the vascular, arterial, and epidural systems. The ports typically include a catheter for access to a large vein and a port body having a septum, which is generally formed from silicone.  
           [0005]    The port is implanted within a cavity formed in the patient, such as in the chest area, and sutured to underlying tissue. From time to time, it is desirable to refill the port via the septum and/or provide an external source of fluid, e.g., IV access. One type of device used to refill an implanted port is generally known as a Huber needle. Known Huber needles generally include a needle extending from a base structure. With sufficient expertise and experience an operator, such as a nurse, can insert the needle into the port via the septum, which is sliced (not cored) by the needle for self-sealing. The Huber needle can then be taped to the patient and fluid delivered to the patient intravenously as desired via a coupled to the Huber needle device.  
           [0006]    However, conventional Huber device can be relatively difficult to remove from the patient. An operator may need to apply a significant amount of force to initiate removal of the device. If the needle suddenly releases, the operator may be accidentally injured by the needle as it is uncontrollably freed from the patient. In addition, even after safe removal, known Huber needle devices can present a hazard due to the outwardly extending needle.  
           [0007]    It would, therefore, be desirable to overcome the aforesaid and other disadvantages.  
         SUMMARY OF THE INVENTION  
         [0008]    The present invention provides a medical device, such as a Huber needle, having a needle and a structure that enhances user safety during removal of the needle from a patient. The inventive structure reduces the likelihood that medical personnel will suffer injury from the needle as it is forcibly removed from the patient. While the invention is primarily shown and described in conjunction with a Huber-type needle, it is understood that the invention is applicable to devices in general in which it is desirable to reduce the possibility of injury from a needle.  
           [0009]    In one aspect of the invention, a medical device includes a central structural member from which a needle extends. At least one wing portion extends from the central structural member for facilitating removal of the needle from the patient in a controlled manner. A base member for contacting the patient&#39;s skin is coupled to the central structural member. First and second members are pivotably secured to the base member so as to provide a structure that can be transitioned from a use position in which the needle extends from the device for insertion into the patient and a non-use position in which the needle is captured by the first member as the needle is extracted from the patient.  
           [0010]    With this arrangement, an operator leverages pressure applied to the wing portion(s) with a finger(s) and counter pressure on the first member so as to enable a controlled removal of the needle from the patient. In addition, the collapsible/expandable structure captures the needle in the first member as it is removed from the patient to enhance operator safety.  
           [0011]    In another aspect of the invention, a medical device has a use position and a non-use position with a housing having first and second portions each having respective first and second ends. The second portion has a first position in the use position and a second position in the non-use position. A longitudinal member has first and second ends and extends from the housing in the use position. In the non-use position, the longitudinal member is captured by the first housing portion. A needle extends from the device in the use position and envelops the device the non-use position. The device can include one or more locking mechanisms to secure the device in the non-use position. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0012]    The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:  
         [0013]    [0013]FIGS. 1A and 1B are perspective schematic depictions of a medical device having enhanced safety in accordance with the present invention in the non-use position;  
         [0014]    [0014]FIG. 2A is a perspective schematic depiction of the medical device of FIG. 1 in the non-use position;  
         [0015]    [0015]FIG. 2B is a perspective schematic depiction of the medical device of FIG. 2A in a use position;  
         [0016]    [0016]FIG. 2C is a bottom perspective view of the device of FIG. 2B;  
         [0017]    [0017]FIG. 3A is a perspective schematic depiction of a medical device having enhanced safety in accordance with the present invention in a non-use position;  
         [0018]    [0018]FIG. 3B is a perspective schematic depiction of the medical device of FIG. 3A in the use position;  
         [0019]    [0019]FIG. 4A is a perspective schematic depiction of an exemplary medical device having enhanced safety in accordance with the present invention shown in a non-use position;  
         [0020]    [0020]FIG. 4B is a top view of the device of FIG. 4A;  
         [0021]    [0021]FIG. 4C is a sectional view of the device of FIG. 4B;  
         [0022]    [0022]FIG. 5A is a top view of the exemplary medical device of FIG. 4A shown in a use position; and  
         [0023]    [0023]FIG. 5B is a sectional view of the device of FIG. 5A along line  5 B.  
         [0024]    [0024]FIG. 6 is a perspective schematic representation of an exemplary medical device shown in a use position in accordance with the present invention;  
         [0025]    [0025]FIG. 7A is a top view of the medical device of FIG. 6;  
         [0026]    [0026]FIG. 7B is a side view of the medical device of FIG. 6;  
         [0027]    [0027]FIG. 7C is a bottom view of the medical device of FIG. 6;  
         [0028]    [0028]FIG. 7D is a cross-sectional view along line  7 D of the medical device of FIG. 7B;  
         [0029]    [0029]FIG. 8A is a top view of the medical device of FIG. 6 in a non-use position;  
         [0030]    [0030]FIG. 8B is a side view of the medical device of FIG. 6 in a non-use position; and  
         [0031]    [0031]FIG. 8C is a front view of the medical device of FIG. 6 is a non-use position. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0032]    FIGS.  1 A- 1 B show a medical device  100  including a needle  102  and a structure for enhanced operator safety in accordance with the present invention. In general, the device structure facilitates removal of the needle from a patient and captures the needle as it is retracted from the patient&#39;s body. During use, the device is relatively flat or collapsed and the needle extends outwardly for insertion into an implanted port device, for example. After use, the device is transitioned to the non-use position in which the needle is captured within the device. As described below, the device can include various features to prevent a transition to the use position from the non-use position to preclude re-use of the device.  
         [0033]    The device  100  includes opposed first and second wing portions  104   a,b  extending from a central structural member  106 . As described below, the wing portions  104  provide surfaces on which an operator can apply pressure to insert the device. This arrangement leverages the force applied to the device so as to provide smooth, and safe, insertion and extraction of the needle from the patient.  
         [0034]    FIGS.  2 A- 2 C show further details of an exemplary medical device  100 ′ having a structure providing enhanced safety features in accordance with the present invention. In general, the device of FIGS. 1A and 1B is similar to the device of FIGS.  2 A- 2 C in which like reference designations indicate like elements. The device  100  includes a series of interconnected members that move with respect to the central structural member  106  for safely transitioning the device from use position to the non-use position. The various members shown in FIGS. 2A and 2B are marked with a particular shape as shown to designate the corresponding parts on each of these figures.  
         [0035]    A first member  110  is pivotably coupled to a skin-contacting base member  108  at a pivot  112 . In an exemplary embodiment, the first member  110  includes an arcuate portion  110   a  for accommodating the stacked members in the use position, as best shown in FIG. 2B. A second member  114 , at respective pivots  116 ,  118 , extends between the base member  108  and the first member  110 . In one embodiment, the second member  114  includes first and second sub portions  114   a,b  joined at a pivot point  120  to enable the second member first and second sub portions  114   a,b  to fold under the first member  110 . It is understood that these members have mirror images on each side of the central structural member  106 .  
         [0036]    The device further includes a raised portion  122  that can form a part of the first member  110 . As shown in FIGS. 2A and 2B, the raised portion  122  can include a depression  124  that can be pressured by a operator&#39;s thumb, for example, to insert the device into the patient. As used herein, the use position refers to the needle outwardly extending from the device for insertion into a patient. In the use position, the device is “flat” or collapsed.  
         [0037]    As shown in FIGS. 2B and 2C, (and  4 C and  5 B) for example, the central structural member  106  can include a slotted channel  126  from which the needle extends perpendicularly, for example. The needle  102  can have an L-shape to facilitate coupling of the needle with a tube (not shown) disposed within the channel  126 . The needle can be secured within the channel  126  in a conventional manner, such as by adhesive.  
         [0038]    The device can include various features to improve the operation and safety of the device. For example, the device can include one or more latches to further enhance operator safety.  
         [0039]    As shown in FIGS.  3 A- 3 B, the device can include a first latching mechanism  150  located at an end of the first member  110 . In one particular embodiment, the first latching mechanism includes a tab  152  to facilitate detachment of a latch member  150   a  from a receiving aperture or cutout  150   b  in the central structural member  106 . The latching mechanism  150  can be released to raise the first member  110  by lifting the tab  152  prior to removal of the device from the patient.  
         [0040]    A second latch  180  shown in FIGS. 3A (and  4 C) for example, can be located at a tip of the first member  110  so that the needle is retained within the first member. In an exemplary embodiment, the needle  102  is captured by an arcuate cavity  182  formed in the first member  110 . Once the device transitions to the non-use position, the second latch  180  prevents the device from transitioning to the use position by retaining the needle within the cavity.  
         [0041]    In another embodiment (not shown), the device can include mechanisms to provide unidirectional movement to the non-use position. In one embodiment, the first member includes a ratchet-type device allowing only movement of the first member  110  away from the base member  108 .  
         [0042]    Referring again to FIGS.  2 A- 3 B, the structure of the device  100  leverages the force applied to the wing portions  104  and the first member  110  to ease extraction of the needle from the patient. In one embodiment, while the device is flush with the patient&#39;s skin, the operator moves the first member  110  to an upright position with respect to the central structural member  106 . The operator then applies first and second fingers underneath the wing portions  104  and a thumb, for example, on or near the tab  152  of the first member  110 . By applying force on top of the upright first member  110 , the implanted port is stabilized in position. The operator can then apply force to lift the wing portions  104  up while applying a counter-force on the first member  110  to leverage the force applied on the wing portions.  
         [0043]    The applied pressure forces the central structural member  106  and wings  104  up and away from the base member  108  and the needle  102  retracts into the cavity  182  in first member  110 . With this arrangement, it is relatively easy for the operator to apply steady pressure to the device for a smooth extraction of the needle from the patient. That is, the needle is not suddenly freed from the patient in a relatively out of control manner. It is understood that the tab  152  can be shaped to facilitate movement of the first member  110  to an upright position and to accommodate force applied to the tab  152  by the operator&#39;s thumb.  
         [0044]    FIGS.  4 A- 5 B show further details of a Huber needle-type device, such as the device  100  of FIGS. 1A and 1B, having enhanced safety features in accordance with the present invention. FIGS.  4 A- 4 C show a device in the non-use position from a perspective, top, and sectional view, respectively. FIG. 5A is a top view of a device in the use position in accordance with the present invention and FIG. 5B is a sectional view taken along line  5 B of FIG. 5A.  
         [0045]    In one embodiment, the devices can be delivered in the use position. As described above, the devices can include various features to prevent a transition from the use position to the non-use position.  
         [0046]    In a further aspect of the invention shown in FIG. 6, a medical device  200 , which is shown in a user position, includes a longitudinal member  202  that slides into a housing  204 . In an exemplary embodiment, the device  200  locks in a non-use position after removal of a needle  206  from a patient. In general, when the device  200  is in the use position, a user can apply finger pressure to first and second wing portions  208   a,b  and thumb pressure to an end  202   a  of the longitudinal member to force retraction of the needle  206  from the patient&#39;s body. When the longitudinal member  202  is captured by the housing  204 , the needle  206  no longer protrudes from the device  200  to enhance operator safety.  
         [0047]    FIGS.  7 A- 8 C show further details of the device  200  shown in FIG. 6. FIGS.  7 A- 7 D show the device  200  in a first or use position and FIGS.  8 A- 8 C show the device  200  in a second or non-use position. A user or operator transitions the device  200  from the use position to the non-use position as described in detail below.  
         [0048]    As shown in FIGS.  7 A- 7 D, in the use position the needle  206  protrudes from the device  200  for insertion into a patient. The device  200  is relatively flat in the use position so that a bottom surface  210  can rest on a patient while the needle  206  is disposed beneath the skin. The extended longitudinal member  202  includes a channel  212 , which can be centered about a longitudinal axis  214  of the device. The needle  206  extends through the channel, which allows axial movement of the longitudinal member. The longitudinal member  202  further includes a first and optional second locking mechanism  216   a ,  216   b  for securing the longitudinal member  202  in the non-use position, as described more fully below.  
         [0049]    In an exemplary embodiment, the housing  204  include first and second portions  204   a ,  204   b  that are secured to each other. In one embodiment, one end of the second housing portion  204   b  is coupled to one end of the longitudinal member  202  and the other end of the second housing portion is coupled to an end of the first housing portion  204   a . Optional first and second wing portions  208   a ,  208   b  extend from the housing first portion  204   a . The wing portions  208  can be arcuate as shown to receive, for example, the application of force by the index and middle fingers of a user.  
         [0050]    A needle retaining member  218  is disposed on the housing  204  for securing the needle  206 , which extends through the channel  212 , in the longitudinal member  202 . The arrangement of the channel  212  and the needle retaining member  218  secures the needle in position while not interfering with movement of the longitudinal member  202  during transition of the device from the use position to the non-use position.  
         [0051]    In one embodiment, the housing  204  further includes first and second locking members  220   a ,  220   b  that mechanically communicate with the first and second locking members  216   a ,  216   b  of the longitudinal member  202 . In general, upon complete insertion of the longitudinal member  202  into the housing  204 , the housing locking members  220  align and interlock with the longitudinal member locking members  216 . In the non-use position, the longitudinal member  202  cannot be removed from the housing  204  to prevent re-use of the device and promote user safety.  
         [0052]    FIGS.  8 A- 8 C show the medical device  200  in the non-use position with the longitudinal member  202  fully inserted into housing  204  and the locking members  216 ,  220  engaged. The second housing portion  204   b  includes a first piece  222   a , and a second piece  222   b  that can pivot with respect to each other. In the non-use position, the first and second pieces  222  form an angle of about ninety degrees in one particular embodiment. The angled first and second pieces  222  extend outwardly from the first housing portion  204   a  so as to envelope the needle  206 . That is, in the non-use position, the needle  206  does not protrude from the device  200 . A slot  224  (FIG. 7C) in the second housing portion  204   a  enables the first and second pieces  222  to pivot unencumbered by the needle  206 .  
         [0053]    In one particular embodiment, the non-pivoting end of the first piece  222   a  is coupled to the end  202   a  of the longitudinal member. As force is applied to the longitudinal member  202  to force it into the housing  204 , movement of the longitudinal member  202  pivots the first piece  222   a  with respect to the second piece  222   b . The non-pivoting end of the second piece  222   b  is coupled to an end of the first housing portion  204   a.    
         [0054]    In an exemplary embodiment, the second housing portion  204   b  includes a series of ribs to create friction as the device  200  transitions to the non-use position during extraction of the needle  206  from the patient. As force is applied to the longitudinal member  202 , the pivoting first and second pieces  222  push against the patient to withdraw the needle  206 .  
         [0055]    It is understood that the device dimensions can vary to meet the needs of a particular application. In one embodiment, the device has a length of about 2.3 inches and a height of about 1.5 inch in the non-use position. The device can have a width measure from ends of the wing portions of about 2.1 inches.  
         [0056]    The inventive medical device shown and described herein can be fabricated from a variety of suitable materials well known to one of ordinary skill in the art. Exemplary materials include plastic, such as PVC, polyethylene, and the like.  
         [0057]    One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.