Patent Document

CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation-in-part of U.S. patent application Ser. No. 11/857,162 filed Sep. 18, 2007, which claims the benefit of Ser. No. 11/449,220 filed Jun. 7, 2006, the teachings of which are hereby incorporated by reference. 
     This application is a continuation-in-part of U.S. patent application Ser. No. 11/959,577 filed Dec. 17, 2007 which claims the benefit of Ser. Nos. 11/77,986 and 11/777,990 both filed Jul. 13, 2007, the teachings of which are hereby incorporated by reference. 
     This application is a continuation-in-part of U.S. patent application Ser. No. 11/250,870 filed Oct. 13, 2005 the teachings of which are hereby incorporated by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     This invention relates generally to ultrasound point-of-care, such as wound care devices, and, more particularly, to deflector shields to protect an operator from splashing from hand-held debridement devices. 
     Debridement is the surgical excision of dead, devitalized, and contaminated tissue, and/or the removal of foreign matter from a wound. Hand-held ultrasound wound debridement devices provide a viable option for wound debridement. Hand-held ultrasound wound debridement devices, generally include a fluid system with an ultrasound system to provide and energize a stream of fluid to dislodge unwanted tissue and foreign matter from a wound and may also include a suction system to collect dislodged matter and the irrigated fluid. However, due to the use of a pressurized solution and the ultrasound energy input, the use of such systems can, disadvantageously, result in the splashing of irrigation fluid, tissues, body fluids and debris from the patient onto, e.g, the health care professional operating the irrigation device increasing risks of disease transmission. 
     Developments have been made to reduce the amount of splash generated from wound debridement devices utilizing a fluid as the mechanism for debridement. Various shields or splash guards have been utilized in an effort to contain and deflect excess irrigation and body fluids away from the health care professional operating the debridement device. Examples of splash shield devices in the prior art include; U.S. Pat. No. 5,441,174 to Sperry, U.S. Pat. No. 6,156,004 to Tremaine et al., US Application No. 2003/0204200 to Rufener, U.S. Pat. No. 6,402,724 to Smith et al. and U.S. Pat. No. 6,293,929 to Smith et al. 
     Conventional splash deflection devices generally comprise structures formed about and extending outwardly from a debridement tip. These prior art devices suffer from numerous deficiencies. For example, the suction created by the debridement tip typically forms a sufficient vacuum to cause conventional splash deflection shields to adhere to the patient during the debridement procedure, resulting in ineffective irrigation of the wound and discomfort to the patient. 
     Conventional shield, or deflection devices, due to their materials of construction and their size and shape, often interfere with the user&#39;s ability to monitor the area being debrided. Additionally, conventional deflection devices are typically incorporated into a debridement tip and are not capable of being retrofitted to alternative wound debridement devices. 
     SUMMARY OF THE INVENTION 
     The present invention includes a splash deflector shield for use with a variety of hand-held ultrasound point-of-care, such as wound care devices. The splash deflector is used to deflect fluid sprayed from the device as well as tissue and other contaminants removed from the wound, away from the operator, more specifically, the operators hand, rather than as a containment device used to contain the aerosolization and splatter as is typical with a number of prior art devices. This use is apparent from the nature and size of the radius of the shield since a deflector has a larger radius and chord length at the distal end while the containment device has a smaller radius and a chord length of approximately the radius at the distal end. 
     The deflector shield is used in cooperation with a number of prior art devices utilizing ultrasound and a fluid spray, including a cryogenic fluid to improve the usability of the prior art devices in certain applications. The deflector shield is capable of being used on point-of-care, such as wound care and wound debridement devices. Materials of construction may be selected so that it can be economically disposed of after each use. The deflector shield may be formed from optically clear materials to provide a deflector shield through which the treated area may be viewed during the medical procedure. 
     The deflector shield is effective at controlling spray backsplash from the wound, yet does not have a tendency to adhere itself to the patient undergoing debridement. 
     The deflector shield acts more as a deflector, i.e. to deflect away from the operator, more specifically, the operators hand, rather than as a containment device i.e. to contain the aerosolization and splatter. 
     The deflector shield may be provided of optically clear materials to prevent visual obstruction of the application or procedure being accomplished. 
     The deflector shield may be flexible and soft to the touch to prevent irritation of the application or procedure site and/or its periphery and when necessary to conform to the site topography. 
     The deflector shield has sufficient inherent structural integrity to not droop or sag under its own weight and flexibility and yet not deform after fabrication or molding or in its packaging from storage or transportation. 
     The deflector shield mounts in a user-friendly fashion, is easy to use, remove or discard, and provides tactile feedback to the operator to ensure it is properly mounted and securely in position. 
     The present invention comprises a transparent shield having a substantially central aperture sized to accommodate an ultrasound tip. With an ultrasound tip traversing the central aperture of the shield of the present invention, the shield is operable to decrease splash generated during use of a debridement device, while not being susceptible to vacuum adhering to the subject patient. 
     Advantageously, the splash deflection shield of the present invention is adapted to be retrofit to both newly manufactured and pre-existing wound debridement devices, and may be used with debridement tips having various configurations and spray patterns. Because the shield of the present invention may be used with such a variety of debridement devices, it is economical and convenient to use. 
     The present invention may provide a splash deflection shield which effectively deflects splash away from the operator and which does not adhere to the patient during use. 
     The present invention may provide a splash deflection shield adapted to be retrofit to various pre-existing wound debridement and other point-of-care devices. 
     The present invention may provide a splash deflection shield for use with a debridement device which does not interfere with, or distort, the operator&#39;s view of the area being debrided. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The aforementioned and other features and objects of this invention, and the manner of attaining them, will become apparent and the invention itself will be better understood by reference to the following description of an embodiment of the invention taken in conjunction with the accompanying drawings, wherein: 
         FIG. 1  is a perspective view of the present invention with a radial orientation of the radiation surface; 
         FIG. 2  is a perspective view of the present invention with a longitudinal orientation of the radiation surface; 
         FIG. 3  is an exploded view of the present invention with a longitudinal orientation of the radiation surface; 
         FIG. 4  is an elevational view of an embodiment of the shield adapter; 
         FIG. 5  is an elevational view of an alternative embodiment of the shield adapter; 
         FIG. 6  is an elevational view of an embodiment of the deflector shield; 
         FIG. 7  is a cross-sectional view of an embodiment of the deflector shield; 
         FIG. 8  is a distal end view of an embodiment of the deflector shield; and 
         FIG. 9  is a distal end view of an embodiment of the deflector shield. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     One embodiment of the deflector shield  40  is shown in use in  FIG. 1  as an element of device  10 . The device  10  consists of an ultrasound generator  11  producing a signal to drive an ultrasound transducer  14 . The ultrasound transducer  14  produces ultrasound waves and is attached to an ultrasound tip  20  to transmit the ultrasound energy to a distal end  21 . 
     The ultrasound transducer may be covered with a housing  17  to isolate the operator&#39;s hand from the transducer. The housing  17  may extend over the ultrasound tip  20 . 
     The ultrasound tip  20  may have an interior passage  12  to deliver fluid  15  to the distal end  21 . The fluid may serve as a coupling medium  16  to transmit ultrasound waves from the ultrasound tip  20  to a wound surface. 
     The ultrasound energy and fluid  15  may be discharged from a radiation surface  24  located on the radial surface  23  of the distal end  21  of the ultrasound tip  20 . The radiation surface  24  may be in the form of a parabolic chamber or spoon shape on the radial surface  23 . The use of a device without the deflector shield  40  is described in U.S. patent application Ser. No. 11/857,162 filed Sep. 18, 2007 which is incorporated by reference in its entirety. 
     As shown in  FIG. 1 , the housing  17  may be attached to a deflector shield  40  that covers portions of the ultrasound tip  20 . The deflector shield may optionally be attached to the housing  17  through a shield adapter  30  that surrounds the tip as a ring. The deflector shield  40  and the shield adapter  30  are preferably physically isolated from the tip to reduce the transmission of vibrations to the housing  17 . 
       FIG. 2  discloses an alternative embodiment of the device  10  shown in  FIG. 1  in which the ultrasound energy is being transmitted through a distal surface  22 . In this embodiment, ultrasound waves are emitted with from the radiation surface  24  with a longitudinal orientation parallel to the axial centerline of the ultrasound tip  20 . The fluid  15 , used as a coupling medium  16  is directed to the wound using a radiation surface  24  with a defined shape on the distal surface  24 . In some embodiments, the ultrasound tip  20  may contain a portion of the interior passage  12  as a chamber  13  to allow mixing, activation and/or additional holding time of the fluid within the ultrasound tip  20 . Various embodiments of the radiation surface  24 , the ultrasound tip  20  and methods for using and focusing the ultrasound radiation are described in U.S. patent application Ser. No. 11/959,577 filed Dec. 17, 2007 the teachings of which are hereby incorporated by reference in its entirety. 
     The use of a device and various embodiments for using and focusing the ultrasound radiation in a device for the cryogenic ablation of tissue without the deflector shield  40  are described in U.S. patent application Ser. No. 11/250,870 filed Oct. 13, 2005 the teachings of which are hereby incorporated by reference in its entirety. 
     An exploded view of the hand-piece of an embodiment of the invention is shown in  FIG. 3 . Optionally, the shield adapter  30  is used to cover portions of the ultrasound tip  20  and may be used to position the deflector shield  40 . The shield adapter  30  is particularly useful when patients are known to have blood or tissue born communicable disease. The shield adapter  30  may attach to the housing  17  through mechanical means such as for example, an O-ring, threaded connection or mechanical tabs. The deflector  40  shield may attach to the shield adapter  30  through alternative mechanical means, examples of which may include an O-ring, threading or mechanical tabs. 
     One embodiment of the removable shield adapter  30  is shown in  FIG. 4 . The shield adapter allows easy installation of alternative shield configurations. To create a press fit the shield adapter  30  may have a protruding ring  31  slightly raised from the exterior surface of the shield adapter  30  to interlock with the deflector shield  40  and a mechanical attachment tab  32  or threaded connection for attachment to the housing  17 . The shield adapter  30  is preferably of a generally open cylindrical shape to provide isolation from the ultrasound tip  20 . 
       FIG. 5  is an elevational view of an alternative embodiment of the shield adapter  30  showing its use as an extension piece with an alternative mechanical attachment tab  32 . 
     A hand piece may be used with or without a deflector shield  40 . The deflector shield  40  is preferably a disposable unit and therefore preferably constructed of a plastic material that generally maintains its shape during use, but exhibits sufficient flexibility in use to allow deformation when necessary for manipulation of the hand piece next to the patients skin without causing discomfort to the patient. Typical materials of use include; pvc, polyethylene or teflon. A silicone elastomer is preferred because of its optical clarity, mechanical characteristics and its low cost allow its economical use as a single-use item. When a deflector shield  40  is used, the deflector shield  40  may be directly coupled to the ultrasound tip  20  or it may be isolated from the ultrasound tip and directly coupled to the housing  17 , or it may be directly coupled to the shield adapter  30 . 
     An embodiment of the deflector shield  40  is shown in  FIG. 6 . The deflector shield  40  may include a hub portion  50  located at the proximal end of the deflector shield  40  and a conical portion  60  located at the distal end of the deflector shield  40   
     The hub portion  50  may be preferably a hollow cylindrical surface with a length  53  and an outer diameter  56 . 
     A conical portion  60  is located at the deflector shield  40  distal end. The conical portion  60  is preferably frusto conical with the profile of an outer surface being a concave surface  61 . The conical portion  60  has an upper base  62  with an upper diameter  63  adjacent the hub portion  50 . The upper diameter  63  is preferably approximately equivalent to the hub diameter  56 . The conical portion  60  distal end preferably has an elliptical or circular outline with a lower diameter  65  and may include a raised lip  69  that includes a ribbed edge to provide structural strength with minimal increased material and weight. 
       FIG. 7  is a cross-sectional view of an embodiment of the deflector shield as shown in  FIG. 6 . A central aperture  41  is sized to at least contain the ultrasound tip  20 . It may also be provided with adequate clearance to prevent direct contact with the ultrasound tip  20 . The deflector shield  40  may contain a receiving cavity  51  located near the interface between the hub portion  50  and the conical portion  60 . The conical portion  60  extends radially from the central aperture  41 . The receiving cavity  51 , formed by the protrusion of the hub portion  50  into the conical portion  60  provides improved performance of the deflector shield  40  by enhancing capture of sprayed fluids and reducing backsplash. Furthermore, the receiving cavity  51  prevents contact of the splashing fluid and debris with the vibrating surface of the ultrasound tip  20  radial portion. This of course reduces reatomization of the backsplash fluid from the radial surface. 
     The cavity also allows channeling of the splashing fluid for effective removal of the collected fluid away from ultrasound tip  20  so that it will not build up and be resuspension or reflection of the fluid back into the air. The receiving cavity  51  also further isolates the conical portion  60  from the ultrasound tip  20 . As the device is positioned during use on a patient, the conical portion  60  may deform when contacted against skin surface. The receiving cavity  51  allows the conical portion  60  to deform without contacting the ultrasound tip  20 . Even with substantial deformation, the conical portion  60  that exceeds the open space provided in the conical portion  60 , the conical portion  60  will contact the hub portion  50  surrounding the ultrasound tip  20  and not contact the ultrasound tip  20  directly. This will prevent excessive unwanted ultrasound energy from being transferred to the patient tissues through the conical portion  60  of the deflector shield  40 . 
     Cylindrical surfaces are optionally provided with a relief of 1.6 degrees to improve manufacturability, assembly and detachment of the deflector shield  40  to the hand piece. The hub may also have a groove  54  located on an inner hub diameter  57  to accept the adapter ring  31  or an O-ring. 
       FIG. 8  is a distal end view of an embodiment of the deflector shield showing a circular embodiment with a lower diameter  65 . 
       FIG. 9  is a distal end view of an embodiment of the deflector shield  40  in an elliptical embodiment with a mechanical tab or snap coupling feature embodiment. 
     Under the preferred embodiment, the deflector shield  40  may have the following dimensions. 
     Conical Portion Lower Diameter: approximately 3.4 inches 
     Hub Outer Diameter: approximately 1.2 inches 
     Hub Length: approximately 1.3 inches 
     Material: Elastomer (Silicone) 
     Finish: Optically Clear 
     Durometer (Hardness): 48-57 (Shore 50A—Medium Soft) 
     The embodiment disclosed is not intended to be exhaustive or to limit the invention to the precise form disclosed in the detailed description. Rather, the embodiments are chosen and described such that others skilled in the art might utilize their teachings. 
     While this invention has been described as having an exemplary design, the present invention may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which the invention pertains.

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