Abstract:
The present invention relates to an intelligent medical device barrier in which a barrier includes sensory means in order to determine if the cover is in place properly and insure single use of the barrier. The sensory means allows one set of readings to be taken using the medical device. The sensory means can provide a lot number, serial number or calibration data to the medical device. After use of the medical device barrier, the sensory means prevents re-use of the barrier for a subsequent procedure.

Description:
CROSS REFERENCE TO RELATED APPLICATION  
       [0001]    This application claims the benefit of U.S. Provisional Patent Application No. 60/425,784, filed Nov. 12, 2002, the entirety of which is hereby incorporated by reference into this application. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    1. Field of the Invention  
           [0003]    The present invention relates to an intelligent medical device barrier to sense when a barrier is properly attached to a medical device thereby insuring proper use and single use of the barrier.  
           [0004]    2. Description of Related Art  
           [0005]    Various medical devices are used in medical procedures. If the medical device can be re-used, it is desirable to assure cleanliness of the device. Conventional methods for sterilizing medical devices include heating, washing and covering of the medical device during use.  
           [0006]    U.S. Pat. No. 6,142,959 describes using a thin elastic protective film to cover a probe head and shaft during use. The thin elastic cover is held by a fixing ring to the handle. The thin elastic cover can be removed from the probe and discarded. Thereafter, a new thin elastic cover can be placed over the shaft before the next use for providing improved hygienics of the prostate examination.  
           [0007]    U.S. Pat. No. 6,582,368 describes a medical instrument sheath formed of a body of a nonconductive material. A piezoelectric copolymer transducer is held snugly against the medical device by the sheath body. The sheath body may be constructed of a shrink tube such as polytetrafluorethylene which shrinks when exposed to heat. After use, the sheath is removed from the medical device and discarded. The medical device may then be used either in conjunction with another sheath or alone. The sheath may also be used in conjunction with a disposable medical device, where both the sheath and the device are disposed of at the end of the procedure. No prior art of which applicant is aware, provides a mechanism for insuring that the elastic cover has been used for a single procedure.  
           [0008]    It is desirable to provide a medical device barrier to communicate with a medical device and to assure single use of the barrier.  
         SUMMARY OF THE INVENTION  
         [0009]    The present invention relates to an intelligent medical device barrier in which a barrier includes sensory means to determine if the cover is in place properly and insure single use of the barrier. The sensory means allows one set of readings to be taken using the medical device. The sensory means can provide a lot number, serial number or calibration data to the medical device. After use of the medical device barrier, the sensory means prevents re-use of the barrier for a subsequent procedure. The medical device barrier covers all surfaces of the medical device which contact tissue to prevent viral or bacterial transmission. For example, in a probe device the barrier covers the probe shaft and probe sensor area in order to prevent probe contact with patient tissue. The invention will be more fully described by reference to the following drawings. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]    [0010]FIG. 1A is a perspective diagram of an intelligent medical device barrier attached to a probe in accordance with the teachings of the present invention.  
         [0011]    [0011]FIG. 1B is a cross sectional view of the intelligent medical device barrier and probe shown in FIG. 1A.  
         [0012]    [0012]FIG. 2A is a perspective view of an alternative intelligent medical device barrier.  
         [0013]    [0013]FIG. 2B is a cross sectional view along line A-A of FIG. 2A.  
         [0014]    [0014]FIG. 2C is a cross sectional view along line B-B of FIG. 2A.  
         [0015]    [0015]FIG. 2D is a cross sectional view along line C-C of FIG. 2A.  
         [0016]    [0016]FIG. 3A is a perspective view of an alternate embodiment of an intelligent medical device barrier attached to a probe.  
         [0017]    [0017]FIG. 3B is a top plan view of a probe handle used with the intelligent medical device barrier shown in FIG. 3A.  
         [0018]    [0018]FIG. 3C is a side elevational view of the probe handle shown in FIG. 3B.  
         [0019]    FIG. 3D is a cross sectional view of the probe handle receiving the medical device barrier.  
         [0020]    [0020]FIG. 3E is a bottom plan view of the probe handle shown in FIG. 3B.  
     
    
     DETAILED DESCRIPTION  
       [0021]    Reference will now be made in greater detail to a preferred embodiment of the invention, an example of which is illustrated in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings and the description to refer to the same or like parts.  
         [0022]    [0022]FIGS. 1A and 1B are schematic diagrams of an embodiment of an intelligent medical device barrier  10  in accordance with the teaching of the present invention. Cover  12  is formed of a similar shape of probe head  13  and probe handle  14  of probe  11 . Cover  12  is received over tip  8  and probe head  13  and is pulled or rolled up over shaft  9  of probe head  13  in order to be used as a barrier to probe  11 . Cover  12  can be received over portion  7  of probe handle  14  for insuring shaft  9  is completely covered by cover  12 . For example, probe  11  can be a probe used for examination of the prostate as described in U.S. Pat. No. 6,142,959, hereby incorporated by reference into this application.  
         [0023]    Retaining means  15  secures cover  12  in place on probe handle  14 . For example, retaining means  15  can be a detent, tab, snap catch, hook or ring for coupling cover  12  to probe handle  14  which inserts, snaps or twists into place on probe handle  14 . Retaining means  15  provides expeditious attachment of cover  12  to probe head  13 . For example, cover  12  can be installed or removed on probe head  13  and probe handle  14  in less than about 10 seconds. Retaining means  15  can be coupled to cover  12 . Alternatively, retaining means  15 , such as a ring, can be placed over cover  12  to press cover  12  against probe handle  14 .  
         [0024]    One or more sensors  16  can be attached to one or more predetermined positions on handle  14 , retaining means  15  or cover  12  for sensing when cover  12  is in place properly on probe head  13 . In one embodiment illustrated in FIG. 2A, sensor  16  is coupled to retaining means  15  and retaining means  15  is attached to cover  12 . Retaining means  15 , such as a detent, is coupled to an indentation or protrusion in probe handle  14 . Upon probe handle  14  engaging retaining means  15 , sensor  16  is activated to indicate that cover  12  is in place on probe handle  14 . If it is determined cover  12  is in place properly on probe head  13 , probe  11  can be activated to enable its use for examination.  
         [0025]    Sensor  16  provides data, such as an identification. The identification can include a lot number or serial number for cover  12 . Alternatively, the identification can be a different state of sensor  16 , such as a different color if cover  12  had been previously used. Data from sensor  16  is forwarded to electronic unit  20  over link  19 . Electronic unit  20  determines from the identification if cover  12  had been previously used. If it is determined cover  12  has not been previously used, electronic unit  20  can be adapted to activate probe  11  to enable its use for examination. If it is determined cover  12  has been previously used, electronic unit  20  can deactivate probe  11  to prevent its use for examination.  
         [0026]    Sensor  16  can also provide an expiration date such as a manufacture date plus a shelf life over link  19 . If it is determined cover  12  is expired, electronic unit  20  can deactivate probe  11  to prevent its use in examination. Sensor  16  can also provide calibration data to probe  11  for operation of probe head  13 .  
         [0027]    One or more sensors  17  receive information upon use of probe  11 . Sensor  17  can be coupled to any position of cover  12 . Alternatively, sensor  17  can be coupled to retaining means  15  or probe handle  14 . Sensor  17  can link through probe handle  14  to electronic unit  20  over link  19 . Data acquisition of probe  11  from sensor  17  can be forwarded over link  19  to electronic unit  20 .  
         [0028]    Sensor  16  can be an integrated circuit. Electronic unit  20  can include a processor, display device, storage unit and central unit. In one embodiment, electronic unit  20  can be a personal computer. Alternatively, electronic unit  20  can be housed in probe handle  14 . In this embodiment, electronic unit  20  comprises a processor and storage unit. Data stored in electronic unit  20  of probe handle  14  can be later uploaded to a remote computing device, such as a personal computer.  
         [0029]    Examples of sensor  17  include restive pad sensors such as manufactured by Tekscan or Vistamed, force sensitive register pads, such as manufactured by PPS, strain gages or MEMS pressure die. For example, link  19  can be a wireless link, optical link or direct electrical connection. Electronic coding of sensor  16  and sensor  17  can be performed by radio frequency (RFID) tag, RFID direct connect, EEPROM, electrical fuse, ink and barcode. For example, in the use of a RFID-tag or RFID direct connect a read/write integrated circuit is used in sensor  16  and/or sensor  17  in probe handle  14 . In RFID-tag, sensor  16  or sensor  17  communicates over a wireless link to probe handle  14 . In RFID-tag direct connect, sensor  16  or sensor  17  communicates over a direct link to probe handle  14 . In EEPROM, a plurality of electrical contacts are used to communicate between sensor  16  or sensor  17  to probe handle  14  to provide an erasable data, such as an identification number or serial number. Alternatively, for example, four electrical contacts can be used in EEPROM. In electrical fuse, electrical contacts are used to communicate between cover  12  and probe handle  14 . For example, two electrical contacts can be used to form an electrical fuse. For example, in the use of ink, the ink can disappear from transparent to opaque upon exposure to heat, temperature or UV. An optical interrupter can be used to detect the change in the ink state. Accordingly, upon use of probe  11 , probe handle  14  can transmit a wavelength of a predetermined intensity for changing the ink state of sensor  16  or sensor  17 . In the case of a barcode, the barcode of sensor  16  or sensor  17  is written on cover  12  or on a label on cover  12 . Electronic unit  20  can include a barcode reader for reading the barcode or the barcode reader can be located on probe  11 .  
         [0030]    Cover  12  can be formed to have a shape similar to the medical device to provide a barrier to protect the medical device. For example, as shown in FIG. 2A, cover  12  can have various cross sectional shapes along lines A-A of FIG. 2B, B-B of FIG. 2C and C-C of FIG. 2D which correspond to the shape of probe  11  and allow pivoting of probe head  13 .  
         [0031]    Coupling means  21  can be used to retain cover  12  on probe  11  in addition to retaining means  15 . For example, coupling means  21  can be a hook.  
         [0032]    In one embodiment, cover  12  can include pull-tab  22  which is pulled to remove cover  12  from probe  11 . Pull-tab  22  is attached to reduced thickness portion  24  of cover  12 . Reduced thickness portion  24  of cover  12  can tear when pull-tab  22  is pulled. Accordingly, after pull-tab  22  tears reduced thickness portion  24 , probe  11  is unable to be re-used in a subsequent procedure and insures single use of cover  12 .  
         [0033]    [0033]FIGS. 3A-3E illustrate an alternate embodiment of an intelligent medical barrier device  30  in accordance with the teachings of the present invention. Cover  29  is coupled to collar  30  at bonding portion  31  of cover  29 , as shown in FIG. 3A.  
         [0034]    Enable switch  32  is formed on portion  33  of probe handle  14 , as shown in FIG. 3B and FIG. 3C. For example, portion  33  can have a circular or elliptical shape for receiving collar  30 . Collar  30  can have a circular shape that can be transformed into an elliptical shape upon receipt over an elliptical probe handle  14  or can have a circular shape to be received over a circular probe handle  14 .  
         [0035]    Enable switch  32  includes upper portion  34  and contact  35 , as shown in FIG. 3D. Collar  30  includes protrusion  36  formed on inner surface  37  of end  38  of collar  30 . Collar  30  has detail  40  formed on inner surface  37  of end  38  of collar  30 . Probe handle  14  includes ledge  42  on portion  33  of probe handle  14 . During operation, collar  30  slides over portion  33  of probe handle  14  until protrusion  36  contacts upper portion  34  of enable switch  32  and detail  40  fits into ledge  42  for snapping collar  30  in place on probe handle  14 . Upon contact of protrusion  36  with upper portion  34  of enable switch  32 , contact  35  is contacted to activate enable switch  32 . Activation of enable switch  32  indicates cover  29  is in place properly on probe  11 . Thereafter, contact with ledge  42  can release collar  30  for detaching cover  29  from probe handle  14 , as shown in FIG. 3E.  
         [0036]    Barcode label  44  can be attached to collar  30 . Electronic unit  20  can include a barcode reader for reading the barcode  44  or the barcode reader can be located on probe  11 . Alternatively, sensor  16  and/or sensor  17  can be attached to collar  30 .  
         [0037]    Cover  12  and cover  29  can be formed of a biocompatible barrier material. Suitable materials for cover  12  include polyurethane, terphalate polyethylene and silicone. Cover  12  and cover  29  can have a wall thickness in the range of about 0.0001 to about 0.015 inches. It is desirable that cover  12  is designed to prevent damage of sensor  16  or sensor  17 . Cover  12  and cover  29  can be sterilized. Cover  12  and cover  29  can be packaged in a sealed sterilized pouch.  
         [0038]    Collar  30  can be formed of a hard plastic material. Cover  12 , cover  29  and collar  30  can be formed by dip molding, one or two shot injection molding, or liquid injection molding.  
         [0039]    In alternate embodiments, cover  12  or cover  29  can have a shape to be compatible with any medical device, such as for example, a catheter, endoscope or ultrasound device. Sensor  16 , sensor  17  or enable switch  32  can be designed to interact with the desired medical device.  
         [0040]    In an alternate embodiment, data on the number of uses of different covers  12  or covers  29  with probe  11  is collected by electronic unit  20 . Probe  11  is activated for a predetermined one or more number of times based on the collected data.  
         [0041]    It is to be understood that the above-described embodiments are illustrative of only a few of the many possible specific embodiments which can represent applications of the principles of the invention. Numerous and varied other arrangements can be readily devised in accordance with these principles by those skilled in the art without departing from the spirit and scope of the invention.