Abstract:
A shoulder implant for simulating a naturally occurring bursa proximal to or in lieu of a subacromial bursa, the shoulder implant comprising: an expandable member expandable to a size and/or a shape sufficient to fill a space beneath an acromion and/or a coracoid process of the shoulder, the space defines a filled volume less than a maximal volume occupied by the expandable member if fully expanded; and an amount of filler for filling the expandable member to the filled volume, such that, when implanted, the expandable member is configured to cushion and facilitate motion between a tendon and/or ligament of a rotator cuff, and a bone part in the shoulder.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 12/531,332 filed on Sep. 15, 2009, which is a National Phase of PCT Patent Application No. PCT/IL2008/000347 having International filing date of Mar. 13, 2008, which claims the benefit of priority of U.S. Provisional Patent Application No. 60/918,051 filed on Mar. 15, 2007. The contents of the above applications are all incorporated herein by reference. 
     
    
     FIELD OF INVENTION 
       [0002]    The present inventions relate generally to the field of medical devices and the treatment of human medical conditions using the medical devices. More specifically, the present inventions include expandable prosthetic devices used for treating a variety of conditions, including rotator cuff injuries, broken and/or depressed bone fractures, infection and/or inflammation in the body. 
       BACKGROUND OF THE INVENTION 
       [0003]    Through repeated strenuous motion, sensitive soft tissues often suffer wear and tear injuries from repeatedly rubbing against one another and/or hard tissues, such as bone. Tears of rotator cuff tendons and articular capsule disintegration are examples of this type of injury. In addition, these tissues can be adversely affected by inflammation, infection, disease and/or genetic predispositions which lead to degeneration of these tissues. 
         [0004]    Other bodily injuries, such as fractures of hollow bones (i.e. having medullar cavities) and depression fractures of vertebra require complex procedures for treatment, for example alignment and fixation of multiple bone fragments for the former and disc replacement for the latter. 
         [0005]    Various solutions to problems in treatment of these injuries have been proposed, for example: 
         [0006]    U.S. Pat. App. Pub. No. 2007/0198022 to Lang, et al., the disclosure of which is incorporated herein by reference, describes methods, compositions and tools for repairing articular surfaces repair materials and for repairing an articular surface. The articular surface repairs are customizable or highly selectable by patient and geared toward providing optimal fit and function. The surgical tools are designed to be customizable or highly selectable by patient to increase the speed, accuracy and simplicity of performing total or partial arthroplasty. 
         [0007]    JP Pat. App. Pub. No. 2006-247257 to Yasuhiko, et al., the disclosure of which is incorporated herein by reference, describes a bone cement injector which is equipped with an injection tube and a balloon detachably mounted on one end of the injection tube, where the balloon is formed with a bioabsorptive material. Using the bone cement injector of this invention, the balloon is inserted into the damaged section of the vertebra to be treated, and subsequently the bone cement is injected into this balloon. Thereby, the bone cement can be injected into the corpus vertebra of the damaged part of the vertebra while preventing the blood from mixing in the bone cement and the bone cement from leaking into the vertebral canal. 
         [0008]    U.S. Pat. App. Pub. No. 2005/0245938 to Kochan, the disclosure of which is incorporated herein by reference, describes a device for repair of intervertebral discs and cartilages in articular joints includes a catheter for inserting through a cannula, the catheter having a distal end and a proximal end and a lumen extending longitudinally therethrough. An expandable balloon may optionally be detachably attached to the catheter near the distal end. The proximal end of the catheter is coupled to an injector that holds a supply of a thermoplastic elastomer material at a predetermined elevated temperature sufficiently high to maintain the thermoplastic elastomer at a liquid state. The device allows a thermoplastic elastomer material to be injected into the intervertegral disc space or the articular joint space as a replacement prosthetic for the disc&#39;s nucleus pulposus or the joint&#39;s cartilage. This procedure is carried out percutaneously through the cannula. 
         [0009]    U.S. Pat. No. 6,755,862 to Keynan, the disclosure of which is incorporated herein by reference, describes an intramedullary support strut for a long bone for a range of different applications including anchoring and fixation. The strut is in the form of nested telescopic members. In the retracted configuration, the strut is compact and may be inserted into position aligned with a shaft made in the medullary canal via a portal made in the lateral cortex of the bone. The strut may then be telescopically extended into the medullary canal to provide the required support. 
         [0010]    U.S. Pat. No. 6,613,052 to Kinnett, the disclosure of which is incorporated herein by reference, describes an apparatus developed to enable a surgeon to perform multiple orthopedic surgical operations, such as orthopedic surgical resectioning, total joint replacement and fixation of fractures, based on a single reference point. The apparatus is adjustable to conform to the needs and dimensions of individual patients and the surgical procedure(s) to be performed. The apparatus includes a support adapted for insertion into and alignment within the medullary cavity of a patient&#39;s bone. The support is capable of expanding into the bone so that the support is fixed within the bone and alignable to the bone. The support may be implanted to align a fractured bone, or extend a distance beyond its fixed position within the medullary cavity to provide a known surgical reference point. The apparatus includes one or more cutting guides mountable on the support and used in performing the desired surgical procedure(s). The cutting guides are positionable with respect to the known surgical reference point created by the support which enables the user to accurately position and secure various instruments at the desired position about the patient&#39;s anatomy. 
       SUMMARY OF THE INVENTION 
       [0011]    An aspect of some embodiments of the invention relates to prostheses adapted to reduce injuries between soft tissues of the body and other tissues. In an embodiment of the invention, soft tissues are for example, tendons and/or ligaments. In an embodiment of the invention, other tissues are, for example, bones. In an embodiment of the invention, the prosthesis is expandable. Optionally, the prosthesis is elastic. In some embodiments of the invention, the prosthesis is rigid. In an embodiment of the invention, the prosthesis is shaped and/or sized to simulate a bursa naturally occurring in the body. Optionally, the bursa simulated is the one expected to be present at the implantation site of the prosthesis in a healthy patient. 
         [0012]    In an embodiment of the invention, an expandable prosthesis adapted to reduce and/or eliminate injury to the rotator cuff. Optionally, the expandable prosthesis is sponge-like. Optionally, the expandable prosthesis is inflatable. In some exemplary embodiments of the invention, the expandable prosthesis is adapted to be inserted between the tendons of the rotator cuff and the acromion and/or coracoid process. Expandable prosthesis is biocompatible and/or biodegradable, in an exemplary embodiment of the invention. Optionally, the expandable prosthesis is adapted to elute pharmaceutical agents once implanted in a patient&#39;s body. In an embodiment of the invention, inflatable expandable prosthesis is inflated with filler, for example a gas, liquid, and/or gel. Optionally, the filler is biocompatible and/or biodegradable. In some embodiments of the invention, the prosthesis is only partially filled. 
         [0013]    In some embodiments of the invention, the prosthesis is provided with anchoring devices adapted to maintain the prosthesis in a steady relationship with the anatomical features around the implantation site. Optionally, the prosthesis is contoured along its exterior to accommodate anatomical features around the implantation site. 
         [0014]    An aspect of some embodiments of the invention relates to a method for implanting an expandable prosthesis adapted to reduce and/or eliminate injury between soft tissues of the body and other tissues, for example to the rotator cuff. In an embodiment of the invention, the expandable prosthesis is either sponge-like or inflatable and is expanded in a space between the tendons of the rotator cuff and the acromion and/or coracoid process. In some embodiments of the invention, a prosthesis implantation and/or inflation device is used to implant and/or inflate the expandable prosthesis. 
         [0015]    An aspect of some embodiments of the invention relates to an expandable prosthesis for the alignment of bone fragments which is provided with walls thick enough to withstand the stresses of normal activity while still maintaining the bone fragments in alignment. In an embodiment of the invention, the expandable prosthesis is inflatable. In some exemplary embodiments of the invention, the expandable prosthesis is adapted to be inserted into the medullar cavity of a plurality of bone fragments. Expandable prosthesis is biocompatible and/or biodegradable, in an exemplary embodiment of the invention. Optionally, the expandable prosthesis is adapted to elute pharmaceutical agents once implanted in a patient&#39;s body. In an embodiment of the invention, inflatable expandable prosthesis is inflated with filler, for example a gas, liquid, cement and/or gel, to provide sufficient rigidity to expandable prosthesis to align a plurality of bone fragments. Optionally, the filler is biocompatible and/or biodegradable. 
         [0016]    In some embodiments of the invention, the prosthesis is provided with a calibration kit which is designed to determine the size and/or shape of the medullar cavity of the bone fragments and/or to choose an appropriate sized prosthesis for implantation into the cavity. 
         [0017]    An aspect of some embodiments of the invention relates to a method for aligning bone fragments using an inflatable, expandable prosthesis. In an embodiment of the invention, an inflatable, expandable prosthesis is introduced into the medullar channel of a plurality of bone fragments. In some embodiments of the invention, a prosthesis implantation and/or inflation device is used to implant and/or inflate the expandable prosthesis. Optionally, pharmaceutical agents are eluted into the patient by the expandable prosthesis. 
         [0018]    An aspect of some embodiments of the invention relates to an expandable prosthesis for treating inflammation and/or infection. Optionally, the expandable prosthesis is a sponge-like structure, sponge-like being defined as including at least one of the following properties: porous, absorbent and/or compressible. Optionally, the expandable prosthesis is inflatable. Expandable prosthesis is biocompatible and/or biodegradable, in an exemplary embodiment of the invention. Optionally, the expandable prosthesis is adapted to elute pharmaceutical agents once implanted in a patient&#39;s body. Expandable sponge-like device optionally contains within its cavities at least one biocompatible and/or biodegradable gelling material that expands when it comes into contact with at least one bodily fluid, for example by absorbing water. 
         [0019]    In an embodiment of the invention, inflatable expandable prosthesis is inflated with filler, for example a gas, liquid, and/or gel. Optionally, the filler is biocompatible and/or biodegradable and/or contains the pharmaceutical agents. In some embodiments, elution of pharmaceutical agents is according to a schedule timed with the biodegradable properties of the expandable prosthesis. 
         [0020]    An aspect of some embodiments of the invention, relates to an expandable prosthesis for treating depressed fractures. In some embodiments of the invention, the expandable prosthesis comprises an inner section and an external section. Optionally, at least one section of the expandable prosthesis is sponge-like. The at least one sponge-like section optionally contains within its cavities at least one biocompatible and/or biodegradable gelling material that expands when it comes into contact with at least one bodily fluid, for example by absorbing water. Optionally, at least one section of the expandable prosthesis is inflatable. In an embodiment of the invention, the at least one inflatable expandable section is inflated with filler, for example a gas, liquid, cement and/or gel, to provide sufficient rigidity to treat the depressed fracture. 
         [0021]    In some exemplary embodiments of the invention, the expandable prosthesis is adapted to be inserted at or near a fractured vertebra. Expandable prosthesis is optionally biocompatible and/or biodegradable, in an exemplary embodiment of the invention. Optionally, the expandable prosthesis is adapted to elute pharmaceutical agents once implanted in a patient&#39;s body. 
         [0022]    In an embodiment of the invention, at least one section of the prosthesis is inflated with filler, for example a gas, liquid, cement and/or gel. Optionally, the filler is biocompatible and/or biodegradable. In some embodiments of the invention, the expandable prosthesis is adapted to have at least one section removed prior to closing the patient. In an embodiment of the invention, at least one section is adapted to withstand the expected pressures from being implanted at or near a vertebra of the patient. In an embodiment of the invention, the expandable prosthesis is inflated and/or implanted using a plurality of prosthesis inflation and/or implantation devices. 
         [0023]    An aspect of some embodiments of the invention relates to a method for treating depressed fractures using an expandable prosthesis. In an embodiment of the invention, the method implants at least one section of an expandable prosthesis comprising a plurality of separately expandable and/or retractable sections. In an embodiment of the invention, at least one section of an expandable prosthesis is used to properly deploy filler for treating the depressed fracture. Optionally, at least one section of the expandable prosthesis is withdrawn from the patient before closing the patient. Optionally, at least one section of the expandable prosthesis is sealed and implanted in the patient. In some embodiments of the invention, pharmaceutical agents are eluted into the patient by the expandable prosthesis. 
         [0024]    An aspect of some embodiments of the invention relates to a prosthesis implantation and/or inflation device. In an embodiment of the invention, the prosthesis implantation and/or inflation device includes a syringe adapted to inject filler into an expandable prosthesis, for example through a tube which operatively connects syringe to the expandable prosthesis. In some embodiments of the invention, the syringe is comprised of at least a plunger and a canister. Optionally, the plunger is advanced through the canister by the device in order to inject filler into the prosthesis. Optionally, the canister is advanced against the plunger, which remains relatively fixed due to counterforce from a backstop, in order to inject filler into the prosthesis. 
         [0025]    In some exemplary embodiments of the invention, the prosthesis implantation and/or inflation device includes a safety. Optionally, the safety comprises at least a spring and a ball, wherein the ball acts as a counterpart to a groove in the backstop. Excessive force on the backstop by continued advancement of the canister towards the plunger triggers the safety, popping the ball out of the groove and freeing the backstop to move. In an embodiment of the invention, the placement of the backstop is according to a predetermined level of desired inflation of the prosthesis. 
         [0026]    There is thus provided in accordance with an embodiment of the invention, a prosthesis for reducing injury to soft tissues of the body, comprising: a member adapted to simulate at least one of a size or a shape of a naturally occurring bursa. 
         [0027]    In an embodiment of the invention, the member is expandable. Optionally, the member is adapted to be at least partially inflated. Optionally, the member is inflated sufficiently to reduce rubbing of the soft tissues against other tissues while permitting at least some movement of the soft tissues relative to the other tissues. Optionally, at least some movement of the soft tissues relative to the other tissues is full movement. In an embodiment of the invention, the member is sponge-like. Optionally, the sponge-like member is provided with a fluid absorbent material which when fluids are absorbed induces expansion of the sponge-like expandable member. 
         [0028]    In an embodiment of the invention, the prosthesis is constructed of at least one of a biocompatible or biodegradable material. Optionally, the at least one of a biocompatible or biodegradable material is PCL, PGA, PHB, plastarch material, PEEK, zein, PLA, PDO, PLGA, collagen or methyl cellulose. 
         [0029]    In an embodiment of the invention, the prosthesis is constructed of at least one non-biodegradable material. Optionally, the at least one non-biodegradable material is polyethylene, polyurethane, silicon, or poly-paraphenylene terephthalamide. 
         [0030]    In an embodiment of the invention, the prosthesis further comprises a rigid ring having a lumen therein attached to the member, wherein the lumen provides fluid communication to an inner space of the member. 
         [0031]    In an embodiment of the invention, the prosthesis further comprises a plug adapted to lodge in the lumen thereby sealing the inner space of the member. Optionally, the plug is constructed of at least one of a biocompatible or biodegradable material. 
         [0032]    In an embodiment of the invention, the member is elastic. 
         [0033]    In an embodiment of the invention, the prosthesis further comprises at least one anchoring device for stabilizing the prosthesis upon implantation. Optionally, the at least one anchoring device is constructed of at least one of a biocompatible or biodegradable material. 
         [0034]    In an embodiment of the invention, the member is contoured to act as a counterpart to natural anatomical features of an implantation site. 
         [0035]    In an embodiment of the invention, adapted to elute at least one pharmaceutical agent. 
         [0036]    In an embodiment of the invention, the size of the prosthesis is approximately 2 cm to 10 cm in length along a long axis, approximately 2 cm to 7 cm in length along a short axis and approximately 0.5 mm to 20 mm in height, when expanded. 
         [0037]    In an embodiment of the invention, the member is rigid. Optionally, the member is contoured to act as a counterpart to natural anatomical features of an implantation site while permitting at least some movement of the soft tissues relative to other tissues. 
         [0038]    In an embodiment of the invention, adapted for reducing injury to a rotator cuff. In an embodiment of the invention, adapted for reducing injury to at least one of a flexor or an extensor. In an embodiment of the invention, adapted for reducing injury between a quadriceps and a femur. In an embodiment of the invention, adapted for reducing injury between a skin and a plantar fascia and a calcaneus of the body. In an embodiment of the invention, injury is at least one of inflammation or infection. 
         [0039]    There is further provided in accordance with an exemplary embodiment of the invention, a method for implanting a prosthesis adapted to reduce injury to between soft tissues and other tissues of a body, comprising: placing the prosthesis into an implantation site between the soft tissues and the other tissues; and, simulating with the prosthesis a bursa naturally occurring at the implantation site. In an embodiment of the invention, the method further comprises eluting at least one pharmaceutical agent from the prosthesis at the implantation site. Optionally, placing and simulating occurs without significantly reducing movement of the soft tissues relative to the other tissues. Optionally, the soft tissues are tendons of a rotator cuff and the other tissues are at least one of a humerus, an acromion or a coracoid process. 
         [0040]    There is further provided in accordance with an exemplary embodiment of the invention, a prosthesis for the alignment of bone fragments, comprising: a member adapted to be implanted in the medullar cavity of the bone fragments, wherein the member is provided with an outer wall thickness adapted to accommodate at least a minimum level of rigidity necessary to maintain bone fragment alignment during normal activity. In an embodiment of the invention, the prosthesis further comprises a calibration kit adapted to perform at least one of determining the size of the medullar cavity or introducing the proper sized member into the medullar cavity. Optionally, the member is tubular or vasiform in shape. Optionally, at least the member is constructed of at least one of a biocompatible or biodegradable material. Optionally, the member has an approximate outer diameter between 2 mm and 15 mm and an approximate length between 5 cm and 50 cm. Optionally, the prosthesis is adapted to elute at least one pharmaceutical agent. 
         [0041]    There is further provided in accordance with an exemplary embodiment of the invention, a method for aligning bone fragments, comprising: introducing a prosthesis into the medullar cavity of a plurality of bone fragments; and, inflating the prosthesis to a sufficient rigidity to hold the bone fragments in alignment during normal activity. In an embodiment of the invention, the method further comprises determining the size of the medullar cavity using a calibration kit. 
         [0042]    There is further provided in accordance with an exemplary embodiment of the invention, a prosthesis adapted for treating depressed fractures comprising a plurality of separately expandable and retractable sections. Optionally, the prosthesis comprises an inner section and an outer section, wherein the outer section at least partially surrounds the inner section. Optionally, the inner section is cylindrical and measures approximately 2 cm to 7 cm in diameter and 2 cm to 5 cm in height. Optionally, the inner section and outer section are manufactured from at least one of polyurethane, ultra high molecular weight polyethylene, poly-paraphenylene terephthalamide, PCL, PGA, PHB, plastarch material, PEEK, zein, PLA, PDO and PLGA, collagen, or methyl cellulose. 
         [0043]    There is further provided in accordance with an exemplary embodiment of the invention, a method for treating a depressed fracture using a prosthesis comprising a plurality of separately expandable and retractable sections, comprising: introducing the prosthesis to the implantation area, wherein the fracture is concave in relation to the area; inflating an inner section; inflating an outer section; deflating the inner section; and, filling a cavity left by the deflating of the inner section such that support is rendered to the depressed fracture from the filled cavity. Optionally, the inner section is withdrawn prior to filling the cavity. 
         [0044]    In an embodiment of the invention, the method further comprises withdrawing the outer section after filling the cavity. 
         [0045]    There is further provided in accordance with an exemplary embodiment of the invention, a system for sealing an inflatable prosthesis, comprising: a prosthesis inflation device; a tube operatively connected to the prosthesis near one end and the prosthesis inflation device on the other end; a plug attached to the tube at the prosthesis end of the tube; and, a rigid ring attached to the prosthesis and slidably attached around the tube between the prosthesis inflation device and the plug; wherein pulling the tube towards the prosthesis inflation device causes plug to lodge in the rigid ring, sealing the prosthesis with the plug. Optionally, the plug is attached to the tube by gripping protrusions. 
         [0046]    There is further provided in accordance with an exemplary embodiment of the invention, a method of sealing an inflatable prosthesis, comprising: pulling a tube out of the prosthesis and through a rigid ring; and, lodging a plug located on the end of the tube in the rigid ring. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0047]    Non-limiting embodiments of the invention will be described with reference to the following description of exemplary embodiments, in conjunction with the figures. The figures are generally not shown to scale and any measurements are only meant to be exemplary and not necessarily limiting. In the figures, identical structures, elements or parts which appear in more than one figure are preferably labeled with a same or similar number in all the figures in which they appear, in which: 
           [0048]      FIG. 1  is an illustration of a sponge-like expandable prosthesis adapted to reduce and/or eliminate injury to the rotator cuff, in accordance with an exemplary embodiment of the invention; 
           [0049]      FIG. 2  is a cutaway view of a portion of a prosthesis implantation and/or inflation device and an inflatable expandable prosthesis adapted to reduce and/or eliminate injury to the rotator cuff, in accordance with an exemplary embodiment of the invention; 
           [0050]      FIG. 3  is an anatomical view of a human shoulder with an expandable prosthesis in vivo, in accordance with an exemplary embodiment of the invention; 
           [0051]      FIGS. 4A-C  are cutaway side views showing the progression removably attaching a prosthesis implantation and/or inflation device and an expandable prosthesis, in accordance with an exemplary embodiment of the invention; 
           [0052]      FIG. 5  is a cutaway side view of a portion of a prosthesis implantation and/or inflation device including a counter-pressure sheath and an expandable prosthesis, in accordance with an exemplary embodiment of the invention; 
           [0053]      FIG. 6  is a cutaway side view of an alternative sealing mechanism, in accordance with an exemplary embodiment of the invention; 
           [0054]      FIG. 7  is a flowchart demonstrating a method of implanting an expandable prosthesis, in some exemplary embodiments of the invention; 
           [0055]      FIG. 8  is a cutaway side view of an expandable prosthesis packed prior to use, in accordance with an exemplary embodiment of the invention; 
           [0056]      FIG. 9  is a cutaway side view of a portion of a prosthesis implantation and/or inflation device and an expandable prosthesis for alignment of bone fragments, in accordance with an exemplary embodiment of the invention; 
           [0057]      FIG. 10  is a flowchart showing a method of aligning two or more segments of bone, in accordance with an exemplary embodiment of the invention; 
           [0058]      FIG. 11  is a cutaway side view of an expandable prosthesis for aligning bone fragments in vivo, in accordance with an exemplary embodiment of the invention; 
           [0059]      FIG. 12  is a perspective view of a device for treating inflammation and/or infection, in accordance with an exemplary embodiment of the invention; 
           [0060]      FIG. 13  is a perspective view of a device for treating depressed fractures, in accordance with an exemplary embodiment of the invention; 
           [0061]      FIG. 14  is a perspective view, with a cutaway side view of two vertebrae, of a device for treating depressed fractures of vertebrae, in accordance with an embodiment of the invention; 
           [0062]      FIG. 15  is a flowchart showing a method of treating depressed fractures, in accordance with an exemplary embodiment of the invention; 
           [0063]      FIG. 16  is a cutaway side view of a prosthetic inflation device, in accordance with an exemplary embodiment of the invention; and, 
           [0064]      FIG. 17  is a cutaway side view of an alternate prosthetic inflation device, in accordance with an exemplary embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
       [0065]    As described above, repeated strenuous motion often causes sensitive soft tissues to suffer wear and tear injuries from repeatedly rubbing against one another and/or hard tissues, such as bone. Tears of tendons and/or ligaments and articular capsule disintegration are examples of this type of injury. In addition, these tissues can be adversely affected by inflammation, infection, disease and/or genetic predispositions which lead to degeneration of these tissues. 
         [0066]    Injuries to soft tissues such as tendons can cause pain and impaired function of the area served by the tendon. Typically, a bursa can be found near areas where “friction” injuries due to the rubbing are prone to occur. A bursa is a natural fluid collection that permits movements between tendons and/or ligaments and bone parts and prevents injury to these tendons by acting as a cushion and/or movement facilitator between them. 
         [0067]    In some embodiments of the invention, prostheses described herein are shaped and/or sized to simulate the natural bursa found in the intended area of implantation. For example, in some of the rotator cuff embodiments described below, the described exemplary prostheses are shaped and/or sized to simulate the subacromial bursa. Optionally, the prostheses are sized to supplement a natural bursa which is misshapen and/or undersized, bringing the combination of the natural bursa and the prosthesis into line with the shape and/or size of a healthy bursa. 
         [0068]    The rotator cuff is an anatomical term given to the group of muscles and their tendons that act to stabilize the shoulder and to permit rotation and abduction of the arm. Along with the teres major and the deltoid, the four muscles of the rotator cuff make up the six muscles of the human body which connect to the humerus and scapula. Injury to the tendons and/or these muscles can cause pain and impaired function of the shoulder. The subacromial bursa is a natural fluid collection that permits movement of these rotator cuff tendons beneath the acromion and coracoid process, both of which are part of scapula bone. In some rotator cuff injuries, the subacromial bursa becomes inflamed and suffers from a reduced ability to prevent injury to the tendons through friction. 
         [0069]    Referring to  FIG. 1 , an expandable prosthesis  100  is shown which is adapted to reduce and/or eliminate injury to the rotator cuff, in an exemplary embodiment of the invention. In an exemplary embodiment of the invention, expandable prosthesis  100  is introduced between the above mentioned acromion and coracoid processes and the rotator cuff tendons to prevent continued injury to these body parts and/or to permit relatively unhindered (relative to the movement afforded to the shoulder without treatment) or free shoulder movement, shown and described in more detail with respect to  FIG. 3 . In some embodiments of the invention, expandable prosthesis  100  comprises an expandable member which is a sponge-like structure. It should also be understood that sponge-like expandable prosthesis  100  is adapted to elute pharmacological substances such as anti-inflammatory and/or antibiotic and/or pro-angiogenesis substances, in some exemplary embodiments of the invention. 
         [0070]    In an exemplary embodiment of the invention, sponge-like expandable prosthesis  100  is biodegradable and/or biocompatible. The sponge-like structure is manufactured from at least one biodegradable and/or biocompatible synthetic material such as, but not limited to, polycaprolactone (“PCL”), polyglycolide (“PGA”), polyhydroxybutyrate (“PHB”), plastarch material, polyetheretherketone (“PEEK”), zein, polylactic acid (“PLA”), polydioxanone (“PDO”) and poly(lactic-co-glycolic acid) (“PLGA”), or any combination and/or family members thereof. In some exemplary embodiments of the invention, the sponge-like structure is manufactured from at least one “naturally-derived” biodegradable and/or biocompatible materials such as collagen and/or methyl cellulose. In an exemplary embodiment of the invention, sponge-like expandable prosthesis  100  is imparted expandable properties, at least in part, by placing within its cavities at least one biocompatible and/or biodegradable material which expands after coming into contact with fluids. Optionally, the fluids are bodily fluids. Optionally, the at least one biocompatible and/or biodegradable material is a gel. 
         [0071]    In some exemplary embodiments of the invention, sponge-like expandable prosthesis  100  is non-biodegradable. Non-biodegradable expandable prostheses are manufactured of biocompatible materials such as polyethylene, Kevlar® (poly-paraphenylene terephthalamide), polyurethane or silicon, or any combination thereof, in some embodiments of the invention. In some exemplary embodiments of the invention, the expandable prosthesis is manufactured from biologically derived, biocompatible and/or biodegradable materials such as collagen. In an exemplary embodiment of the invention, prosthesis  100 , when expanded, has approximately the same dimensions as other prostheses when expanded, described below. 
         [0072]    Referring to  FIG. 2 , a cutaway view of a portion of a prosthesis implantation and/or inflation device  200  and a prosthesis  202  with an expandable member which is inflatable is shown, in accordance with an exemplary embodiment of the invention. Exemplary embodiments of prosthesis implantation and/or inflation device  200  are described in more detail with respect to  FIGS. 16-17 . In an exemplary embodiment of the invention, inflatable expandable prosthesis  202  is introduced between the above mentioned acromion and coracoid processes and the rotator cuff tendons to prevent continued injury to these body parts and/or to permit relatively unhindered or free shoulder movement, shown and described in more detail with respect to  FIG. 3 . Optionally, alternatively and/or additionally, an expandable prosthesis comprises an inflatable structure and a sponge-like structure in combination. 
         [0073]    In an exemplary embodiment of the invention, inflatable expandable prosthesis  202  is rectangular shaped when deflated and resembles a cuboid parallelepiped when inflated. In an exemplary embodiment of the invention, inflatable expandable prosthesis  202  is circular or oval in shape when deflated and when inflated resembles a cylindrical disc or ovoid. It should be understood, however, that many shapes could be adapted to be implanted between the acromion and coracoid processes and the rotator cuff tendons to prevent at least some injury to the rotator cuff and/or to permit relatively unhindered or free shoulder movement for a patient, in an exemplary embodiment of the invention. In some embodiments of the invention, prosthesis  202  is adapted to be inserted deflated into a patient&#39;s body through a cannula. Optionally, the cannula is a 5 mm-7 mm cannula. In an embodiment of the invention, a long axis  204  (x-axis) of inflatable expandable prosthesis  202  is approximately 2 cm to 10 cm in length when inflated. In some embodiments of the invention, a short axis  208  (y-axis) of inflatable expandable prosthesis  202  is approximately 2 cm to 7 cm in length when inflated In some exemplary embodiments of the invention, inflatable expandable prosthesis  202  is 0.5 mm to 20 mm in height (z-axis). Optionally, inflatable expandable prosthesis  202  is 1 mm to 10 mm in height. It should be understood that the deflated and/or inflated size of prosthesis  202  is adapted to fit for a patient&#39;s particular needs or to simulate the size and/or shape of the natural bursa, in an embodiment of the invention, and therefore, prosthesis  202  does not necessarily conform to the size ranges given above. 
         [0074]    Inflatable expandable prosthesis  202  is manufactured by dip molding, in an exemplary embodiment of the invention. In some embodiments of the invention, inflatable expandable prosthesis  202  is a seamless balloon-like structure made from biocompatible and/or biodegradable synthetic materials such as, but not limited to, PCL, PGA, PHB, plastarch material, PEEK, zein, PLA, PDO and PLGA, or any combination and/or family members thereof. Additionally, optionally and/or alternatively, inflatable expandable prosthesis  202  is manufactured from natural, biocompatible and/or biodegradable materials such as collagen and/or methyl cellulose. In some exemplary embodiments of the invention, the inflatable prosthesis  202  is manufactured from at least one non-biodegradable material such polyethylene, polyurethane, silicon, and/or Kevlar®. In an embodiment of the invention, prosthesis  202  is comprised of a material which is approximately 100 microns in thickness, although, as with the other dimensions, the thickness dimension of the material is adapted depending on the intended use and/or the needs of the patient. In some exemplary embodiments of the invention, inflatable expandable prosthesis  202  is adapted to elute pharmaceuticals such as anti-inflammatory drugs and/or antibiotics and/or pro-angiogenesis factors to promote healing. 
         [0075]    Inflatable expandable prosthesis  202  is releasably attached to prosthesis implantation and/or inflation device  200 , in an exemplary embodiment of the invention. Prosthesis implantation and/or inflation device  200  is adapted to inflate and/or deflate prosthesis  202 , allow prosthesis  202  to be positioned in vivo, and/or separate from prosthesis  202  after implantation, leaving prosthesis  202  at the implantation site, in an embodiment of the invention. In some exemplary embodiments of the invention, prosthesis implantation and/or inflation device  200  includes a tube or catheter type structure  204  which interfaces with prosthesis  202  in the proximity of a sealing mechanism  206  which is located at the end of tube  204  nearest prosthesis  202 . 
         [0076]    In an embodiment of the invention, sealing mechanism  206  includes a plug  402 , shown in  FIG. 4B  inter alia, attached to the end of tube  204  nearest prosthesis  202 . In an embodiment of the invention, plug  402  is constructed of the same material or materials as any of the prostheses described herein. Tube  204  is adapted to allow passage therethrough of the substance used to fill prosthesis  202 , for example by placing at least one orifice  404  in tube  204 . In some embodiments of the invention, air is used to inflate prosthesis  204 . Additionally, alternatively and/or optionally, a biodegradable and/or biocompatible substance is used to inflate prosthesis  202 . In some embodiments of the invention, a gel or liquid is used to inflate prosthesis  202 . In an embodiment of the invention, tube  204  is provided with gripping protrusions  406  in order to increase the contact surface between tube  204  and plug  402  and therefore the force that may be applied to plug  402  when sealing prosthesis  202 . In some embodiments of the invention, plug  402  is ovoid shaped, and/or has a shape such that plug&#39;s  402  loose end  408  is larger than the attached end  410  so that, as described in more detail below with respect to  FIGS. 4A-C ,  5  and  7 , plug  402  seals inflatable expandable prosthesis  202  during implantation. 
         [0077]      FIGS. 4A-C  are cutaway side views showing the progression of removably attaching prosthesis implantation and/or inflation device  200  and prosthesis  202 , in accordance with an exemplary embodiment of the invention. Referring to  FIG. 4A , a rigid ring  412  is cast on tube  204  of prosthesis implantation and/or inflation device  200 , in an embodiment of the invention. In an embodiment of the invention, rigid ring  412  fits snugly onto tube  204  such that air and/or other fluid injected into prosthesis  202  does not escape via the intersection of rigid ring  412  and tube  204 , however tube  204  is slidable in relation to rigid ring  412 . This slidability is useful, for example, when prosthesis implantation and/or inflation device  200  is separated from prosthesis  202  in accordance with an exemplary embodiment of the invention. In an exemplary embodiment of the invention, plug  402  is cast on tube  204  such that gripping protrusions  406  grasp at least a portion of attached end  410  of plug  402 , shown in  FIG. 4B . Optionally, dip molding, or any other method known in the art, is used for manufacturing plug. At least tube  204  and/or plug  402  and/or rigid ring  412  are made of biodegradable and/or biocompatible materials, in an embodiment of the invention. 
         [0078]    Rigid ring  412  is cast on tube  204  before plug  402  is cast tube  204  because in an exemplary embodiment of the invention, plug  402  has a larger diameter than the inner diameter of rigid ring  412  thereby preventing plug  402  from passing through rigid ring  412 . In an embodiment of the invention, inflatable expandable prosthesis  202  is placed around plug  402  and tube  204  such that tube  204  and plug  402  extend into a cavity proscribed by prosthesis  202 . Prosthesis  202  is attached to an exterior surface of rigid ring  412  such that air and/or other fluid injected into prosthesis  202  does not escape via the intersection of prosthesis  202  and rigid ring  412 , in an embodiment of the invention. Optionally, a thermal method is used to attach prosthesis  202  to rigid ring  412 . 
         [0079]      FIG. 5  shows an assembly  500  including a portion  502  of inflation device  200  and a portion  504  of expandable prosthesis  202  further comprising a counterforce ring  506 , in accordance with an exemplary embodiment of the invention. In an embodiment of the invention, counterforce ring  506  is adapted to apply counterforce to rigid ring  412  during separation of prosthesis inflation device  200  from prosthesis  202 , as described in more detail below with respect to  FIG. 7 . In some embodiments of the invention, counterforce ring  506  is constructed of a biocompatible material, for example stainless steel and/or plastic, that is approximately at least as hard as rigid ring  412 . 
         [0080]    In some embodiments of the invention, at least one unidirectional valve  600 , shown in  FIG. 6 , is used in addition to or alternatively to plug  402  and rigid ring  412  for sealing prosthesis  202  after at least partially inflating prosthesis  202  with prosthesis implantation and/or inflation device  200 . 
         [0081]      FIG. 3  shows an anatomical view of a human shoulder  300  with an expandable prosthesis  100 ,  202  in vivo, in accordance with an exemplary embodiment of the invention. Prosthesis  100 ,  202  is inserted between the acromion  302  and the coracoid process  304 , in an embodiment of the invention. In some embodiments of the invention, prosthesis  100 ,  202  and any other prosthesis described herein, is inserted proximal to the bursa  306 . Optionally, if there is no bursa  306  of any remarkable size, the prosthesis is inserted in lieu of bursa  306 . In an embodiment of the invention, an implanted prosthesis, such as those described herein, is adapted to cover the humerus head during shoulder  300  motion, while remaining relatively fixed in relation to the acromion  302  and/or the coracoid process  304 . 
         [0082]    In some embodiments of the invention, an anchoring expandable prosthesis is adapted to prevent and/or reduce injury to the rotator cuff and/or to permit relatively unhindered or free shoulder movement. The anchoring expandable prosthesis comprises an expandable member and at least one anchoring device which is adapted to be attached to a part of the patient, for example the humerus head/tendons, acromion and/or coracoid process, thereby anchoring the prosthesis in place. In an embodiment of the invention, the anchoring expandable prosthesis comprises at least one anchoring device attached to an expandable portion adapted to operate similarly to prostheses  100 ,  202 . The at least one anchoring device is manufactured of biocompatible and/or biodegradable or non-biodegradable metals and/or alloys and/or composites, for example titanium, stainless steel or magnesium alloys. In an embodiment of the invention, the expandable portion is manufactured of biocompatible and/or biodegradable or non-biodegradable materials such as high density polyethylene or those described with respect to prostheses  100 ,  202 . In an embodiment of the invention, the at least one anchoring device is attached to the expandable member using filaments and/or wires. 
         [0083]    In some embodiments of the invention, prostheses described herein are adapted for anchoring, for example by contouring the outer surface such that surrounding tissues can be placed within the contours, thereby “anchoring” the device. In some embodiments of the invention, the contours are adapted to act as counterparts to anatomical features at the implantation site, whereby the features settle into the contours upon implantation, but still permit relatively unhindered movement of the treated area. 
         [0084]    Prostheses  100 ,  202 , and/or any of the other prostheses described herein, are adapted for use in places where there is sliding of soft tissues, such as tendons against other tissues, such as bones as: a) between the quadriceps and femur after operations on the knee, b) near the finger flexor and/or extensor to prevent adhesions, for treatment of ailments such as carpal tunnel syndrome or, c) between the skin and plantar fascia and calcaneus in case of calcaneal spur, in some exemplary embodiments of the invention. As described above, the prosthesis used for treatment of particular ailments is sized and/or shaped to simulate the natural bursa found at the location being treated, in an exemplary embodiment of the invention. 
         [0085]    In an embodiment of the invention, an expandable prosthesis which is least slightly elastic, but not inflatable, is adapted to prevent and/or reduce injury to the rotator cuff and/or to permit relatively unhindered or free shoulder movement. In some embodiments of the invention, the elastic prosthesis is manufactured from polyethylene and/or silicon and/or in combination with metals, such as titanium. Optionally, the elastic prosthesis is contoured to serve as a counterpart to the surfaces with which it will come into contact. For example in the case of a rotator cuff, the elastic prosthesis may be contoured to fit at least the acromion. 
         [0086]    In an embodiment of the invention, a prosthesis is provided which is substantially rigid. The rigid prosthesis is constructed of a biocompatible material, for example stainless steel and/or a hard plastic, in some embodiments of the invention. Optionally, the rigid prosthesis is also biodegradable. In some embodiments of the invention, the rigid prosthesis is adapted to act as a counterpart to at least one anatomical feature at the implantation site, whereby the feature mates with the rigid prosthesis upon implantation, but still permits relatively unhindered movement of the treated area. As an example, the rigid prosthesis is adapted to mate with both the humerus head and the acromion upon implantation, in an embodiment of the invention. 
         [0087]    Referring to  FIG. 7 , a method  700  of implanting an expandable prosthesis  100 ,  202 , or any other prosthesis described herein is described, in some exemplary embodiments of the invention. In an embodiment of the invention, implantation method  700  is adapted for implantation of prostheses  100 ,  202 , or any other prosthesis described herein, into the shoulder of a patient to prevent and/or reduce injury to the rotator cuff and/or to permit relatively unhindered or free shoulder movement. In an embodiment of the invention, prostheses  100 ,  202 , or any other prosthesis described herein, are introduced percutaneously or by making ( 702 ) a small incision, optionally performed by posterior, lateral or anterior approaches using, for example, palpation, arthroscopy, ultrasound (“US”), computed tomography (“CT”), magnetic resonance imaging (“MRI”), fluoroscopy, transmission scan (“TX”), or any combination thereof. In an embodiment of the invention, a needle is inserted ( 704 ) into the space between the rotator cuff tendons and the acromion  302  and coracoid process  304 . A guide wire is introduced ( 706 ) via the needle into the space between the rotator cuff tendons and the acromion  302  and coracoid process  304 , in an exemplary embodiment of the invention. In some embodiments of the invention, a dilator is placed ( 708 ) over the guide wire and extended into the space. Subsequently, a trocar of the dilator is removed ( 710 ), leaving a dilator sheath in place. 
         [0088]    In an embodiment of the invention, inflatable expandable prosthesis  202  is placed ( 712 ) into the space using the dilator sheath and/or the prosthesis inflation device  200  for guidance and/or movement impetus. Once prosthesis  202  is approximately in the proper position, the dilator sheath and an external sheath  802  of prosthesis inflation device  200 , shown and described in more detail with respect to  FIG. 8 , are withdrawn ( 714 ) to allow for inflation ( 716 ) of prosthesis  202 . Inflation ( 716 ) using prosthesis inflation device  200  is described in more detail below. Inflation ( 716 ) of prosthesis  202  is achieved, in some embodiments of the invention, during arthroscopy. In some embodiments of the invention, for example if prosthesis  202  is implanted during open surgery or arthroscopy, proper deployment of prosthesis  202  is ascertained by visual inspection of prosthesis  202 . In an embodiment using arthroscopy, prosthesis may be introduced through an arthroscopy port. In some embodiments of the invention, inflation ( 716 ) is achieved using palpation and US guidance to ascertain proper deployment of prosthesis  202 . In some embodiments of the invention, inflation ( 716 ) is achieved using fluoroscopy to ascertain proper deployment of prosthesis  202 . Proper deployment of prostheses, in some embodiments of the invention, means no interposition of tendons and/or other soft tissue between the implanted prosthesis and acromion  302  or coracoid process  304  and/or that during movement of the humerus, the prosthesis remains below acromion  302 . 
         [0089]    Inflation ( 716 ) of prosthesis  202  is performed using prosthesis inflation device  200 , in an embodiment of the invention. It should be understood that only a portion of prosthesis inflation device  200  is shown in  FIG. 2 , and that exemplary variations are shown in more detail with respect to  FIGS. 16-17 . Referring to  FIG. 8 , an expandable prosthesis  202  is shown packed for implantation and prior to deployment, in accordance with an exemplary embodiment of the invention. Components of the assembly  800  are enclosed in an external sheath  802  which surrounds at least prosthesis  202 , in an exemplary embodiment of the invention. External sheath  802  is adapted to maintain prosthesis  202  in a collapsed condition during placing ( 712 ) in order to ease insertion of prosthesis  202  into the implantation space or site through the dilator sheath, in an embodiment of the invention. As described above, once prosthesis  202  is in the implantation space, external sheath  802  is removed, enabling prosthesis  202  to be inflated without hindrance apart from the body parts against which prosthesis  202  is pressing. 
         [0090]    In an embodiment of the invention, inflation ( 716 ) of prosthesis  202  is performed using a physiologic fluid such as saline, Hartman or Ringer solutions and/or any other biocompatible and/or biodegradable fluid. In some embodiments of the invention, inflation ( 716 ) is performed using a biocompatible and/or biodegradable gel. In an embodiment of the invention, inflation ( 716 ) of prosthesis  202  is performed using a gas, for example air and/or carbon dioxide. In some embodiments of the invention, the inflating gel and/or fluid contains pharmaceutical agents, for example anti-inflammatory drugs and/or antibiotics and/or pro-angiogenesis factors to promote healing, which are eluted into the patient&#39;s body. In some embodiments of the invention, prosthesis  202  is inflated to the maximum volume possible without reducing the shoulder&#39;s range of movement. In an embodiment of the invention, prosthesis  202  is filled to less than its maximum volume in order to permit shifting of the contents of prosthesis  202  during movement. Optionally, prosthesis  202  is filled to 60%-70% of its maximum volume (for example, an expandable member with a  14 cc volume is filled with 9 cc of filler). It should be noted that other prosthesis embodiments described herein are deployed in a similar fashion, in some embodiments of the invention. 
         [0091]    Sealing ( 718 ) of prosthesis  202 , once inflated to the desired level, is performed by pulling tube  204  towards rigid ring  412  as they slide in relation to one another plug  402  becomes lodged in a lumen  804  of rigid ring  412  and continued pulling brings rigid ring  412  into contact with counterforce ring  506 , in an embodiment of the invention. In an embodiment of the invention, tube  204  passes through lumen  804  with lumen  804  providing fluid communication between prosthesis implantation and/or inflation device  200  and an inner space defined by the dimensions of prosthesis  202 . In an embodiment of the invention, an attending medical professional performing the implantation procedure holds counterforce ring  506  substantially steady while pulling on tube  204  away from the patient. Optionally, prosthesis inflation device  200  is adapted to perform the steadying of counterforce ring  506  and/or retraction of tube  204  automatically. In some embodiments of the invention, a mechanism is provided to prosthesis inflation device  200  which translates rotational movement to a retracting force on tube  204 . Optionally, rotation movement is applied manually. 
         [0092]    Continued pulling (“retraction” away from patient) of tube  204  causes a portion of plug  402  to break off, the portion of plug  402  lodging itself in lumen  804  of rigid ring  412  thereby sealing prosthesis  202 . In some embodiments of the invention, the portion of plug  402  becomes partially deformed as it lodges in lumen  804 . Prosthesis inflation device  200 , now being separated from prosthesis  202  as a result of sealing ( 718 ) is withdrawn ( 720 ) from the patient and patient is closed, in an exemplary embodiment of the invention. It should be understood that in some embodiments of the invention, a sponge-like expandable prosthesis device is used and therefore, inflation ( 716 ) and inflation related actions may not be carried out, for example prosthesis  100  expands rather than inflates. 
         [0093]    In an exemplary embodiment of the invention, the implanted prosthesis is secured, using methods known in the art, to soft tissue and/or bone to prevent the prosthesis from being easily displaced by shoulder movement. In some embodiments of the invention, sutures, clips and/or anchors are used to secure the prosthesis in place. Optionally, an anchoring expandable prosthesis is used. In an embodiment of the invention, simulating a naturally occurring bursa using a prosthesis is an action taken with respect to method  700 . Optionally, simulating is related to inflation ( 716 ) in that the prosthesis is inflated to resemble the appropriate size and/or shape and/or characteristics (malleability, compressibility, etc.) of the naturally occurring bursa. In an embodiment of the invention, placing the prosthesis at the implantation site and simulating a naturally occurring bursa does not significantly reduce movement of the soft tissues being protected in relation to the other tissues at the implantation site. 
         [0094]    In an exemplary embodiment of the invention, prosthesis  100  is implanted by placing prosthesis  100  into a cannula, such as those described elsewhere herein, and advancing it to the implantation site using a plunger. 
         [0095]    In an exemplary embodiment of the invention, prosthesis  100  or the elastic prosthesis, described above, is implanted by inserting the device directly through a small incision, without a cannula, near the implantation site. 
         [0096]    It should be noted that the method shown and described with respect to  FIG. 7  is by way of example only, and that similar methods could be used for implantation of any bursa simulating prosthesis adapted for reducing injuries between soft tissues and other tissues of the body. 
         [0097]    Referring to  FIG. 9 , a cutaway side view of a portion of a prosthesis implantation and/or inflation device  900  and an expandable prosthesis  902  for alignment of bone fragments in the case of fractures of tubular bones is shown, in accordance with an exemplary embodiment of the invention. Prosthesis  902  is adapted to fit in the medullar cavity of the bone in which it is intended to be used and is optionally biodegradable and/or biocompatible. In an embodiment of the invention, prosthesis  902  is intended to be used in non-weight bearing bones, for example, the humerus, radius, and ulna. Prosthesis  902  comprises an inflatable tubular member  904  which is generally shaped to fit within a medullar cavity of the bones to be aligned. Optionally, inflatable tubular member  904  is tubular or vasiform. Optionally, inflatable tubular member  904  is slightly curved. In an embodiment of the invention, inflatable tubular member  904  has an approximate outer diameter ranging between 2 to 15 mm and having an approximate length ranging between 5 to 50 cm. Optionally, the outer diameter ranges between 4 to 10 mm. Optionally, the length ranges between 10 and 30 cm. In an embodiment of the invention, prosthesis  902  is sized and/or shaped to fit into the medullar cavities of the bone fragments which are intended to be aligned. 
         [0098]    Prosthesis  902  is releasably attached to prosthesis implantation and/or inflation device  900  and/or inflated in a similar fashion as described with respect to prosthesis  202  and implantation and/or inflation device  200 , in an embodiment of the invention. 
         [0099]    At least part of prosthesis  902  (e.g. tubular member  904 ) is manufactured, in an embodiment of the invention, by dip molding. Optionally, inflatable tubular member  904  is a seamless balloon made from biocompatible and/or biodegradable synthetic materials such as, but not limited to, PLA, PLGA, PCL, PDO, or any combination and/or families thereof. In an embodiment of the invention, inflatable tubular member  904  is provided with an outer wall thickness adapted to accommodate at least a minimum level of rigidity necessary to maintain the aligned bone fragments during normal activity. For example, forearm bones are normally subjected to forces ranging from a few hundred grams to several kilograms during normal activity. As another example, metacarpal bones are normally subjected to tens of grams to a few hundred grams of force. It should be noted that these ranges are provided as examples only and that depending on patient and/or the bone fragments being aligned, the wall thickness of inflatable tubular member will be adapted to maintain alignment of the bone fragments in spite of the anticipated stress on prosthesis  902  during normal activity and/or rehabilitation of the patient. 
         [0100]    In an exemplary embodiment of the invention, inflation of prosthesis  902  is performed using a physiologic fluid such as saline, Hartman or Ringer solutions and/or any other biocompatible and/or biodegradable fluid. In some embodiments of the invention, inflation is performed using a biocompatible and/or biodegradable gel. In an embodiment of the invention, inflation of prosthesis  902  is performed using a gas, for example air and/or carbon dioxide. In an embodiment of the invention, prosthesis  902  is filled with a cement that hardens and/or seals the open end  906  of prosthesis  902 . In some embodiments of the invention, the cement is used provide alignment for the fractured bone segments. 
         [0101]    In an exemplary embodiment of the invention, prosthesis  902  is adapted to elute at least one pharmaceutical agent, for example anti-inflammatory drugs and/or antibiotics and/or bone deposition promoting factors and/or pro-angiogenesis factors to promote healing of the fracture. 
         [0102]    In some embodiments of the invention, prosthesis  902  (and/or other prostheses described herein) is used with a calibration kit which determines the size of the medullar cavity and/or the proper size inflatable tubular member  904  to use with the medullar cavity. Optionally, the calibration kit is integrated with prosthesis  902 . Optionally, the calibration kit is integrated with prosthesis implantation and/or inflation device  900 . In an embodiment of the invention, a calibration expandable member is first deployed into the medullar cavity to measure the cavity shape and/or size and then upon deployment of prosthesis  902 , its shape and/or size is adapted to match the needs of the measured medullar cavity. Optionally, various sizes of dilators are used in conjunction with the calibration expandable member to assist with determining size. 
         [0103]      FIG. 10  is a flowchart  1000  showing a method of aligning two or more segments of bone, in accordance with an exemplary embodiment of the invention. Reduction ( 1002 ) of the fracture is performed, in an exemplary embodiment of the invention, by closed reduction. The closed reduction maneuvers are performed under fluoroscopic and/or TX guidance, in some embodiments of the invention. A skin incision is performed ( 1004 ) over a first segment of bone. In an embodiment of the invention, a hole is drilled ( 1006 ) through the compact bone of one of the bone segments near the epiphyseal plate into the medullar channel and a guide wire is introduced ( 1008 ) through this medullar channel and advanced ( 1010 ) into the medullar channel of the other segment of bone passing through the fracture site. When more than two fragments of bone exist, in an embodiment of the invention, the wire passes through the medullar channels of all segments. 
         [0104]    A calibration device comprising a sheath and an internal trocar is passed ( 1012 ) over the wire through the medullar channels of the bone segments, in an embodiment of the invention. The internal trocar and the wire are removed ( 1014 ) leaving inside only the external sheath of the calibration device within the medullar channel of the bone segments, in an exemplary embodiment of the invention. Prosthesis  902  is introduced ( 1016 ) into this sheath, in an embodiment of the invention. The calibration device sheath and the external sheath of prosthesis  902  (similar in form and function to external sheath  802 ) are removed ( 1018 ) in an embodiment of the invention and the unexpanded prosthesis  902  remains in the medullar channels of the segments of bone. 
         [0105]    In an embodiment of the invention, prosthesis  902  is inflated ( 1020 ) as described above with a biocompatible and/or biodegradable filler and the prosthesis  902  is detached ( 1022 ) sealing prosthesis  902  under pressure. The sealing is performed using any of the previously described methods or by any method known to those skilled in the art. In an embodiment of the invention, prosthesis  902  remains within the reduced bone segments keeping them in alignment, as shown in  FIG. 11 . The skin incision is closed ( 1024 ). In some embodiments of the invention, healing of the bone fragments is accelerated by eluting pharmaceutical agents from prosthesis  902 . 
         [0106]    In an embodiment of the invention, alignment of the bone segments is maintained by the rigidity of prosthesis  902 . In an embodiment of the invention, the rigidity of prosthesis  902  at least partly depends on the internal pressure of prosthesis  902 , the internal pressure being at least partly determined by the filler used and/or the percentage of prosthesis  902  that is filled by the filler. Optionally, an external cast is placed on the area proximal to the fracture. 
         [0107]      FIG. 12  is a perspective view of a device  1200  for treating inflammation and/or infection, in accordance with an exemplary embodiment of the invention. In an embodiment of the invention, device  1200  is a sponge-like structure. In some embodiments of the invention, device  1200  is an inflatable structure. Device  1200  is adapted to be placed at a site in the body for treating inflammation and/or infection, in an embodiment of the invention, in an embodiment of the invention. 
         [0108]    In an exemplary embodiment of the invention, a sponge-like device  1200  is manufactured of biocompatible and/or biodegradable synthetic materials such as, but not limited to, PLA, PLGA, PCL, PDO, or any combination thereof. Alternatively and/or additionally and/or optionally, it may be manufactured from biologically derived biodegradable materials such as collagen. Expandable sponge-like device  1200  optionally contains within its cavities at least one biocompatible and/or biodegradable gelling material, such as methyl cellulose, agarose, poly(ethylene-glycol) (“PEG”) gel and/or PLA gel, that expands when it comes into contact with at least one bodily fluid, for example by absorbing water. In an embodiment of the invention, such absorption is partly responsible for an expansion of sponge-like device  1200  into its intended deployed position. 
         [0109]    As described above, in some exemplary embodiments of the invention, device  1200  comprises an inflatable structure. In an embodiment of the invention, inflatable device  1200  is constructed of at least one biocompatible and/or biodegradable material, such as those described herein. In some embodiments of the invention, inflatable device  1200  is spherical or cylindrical, having a diameter of 0.5 cm to 5 cm for a sphere or in the long direction (x-axis) and 0.5 cm to 4 cm in the short direction (y-axis) and a height (z-axis) of 0.5 mm to 20 mm. In some embodiments of the invention, device  1200  is adapted to be inserted deflated into a patient&#39;s body through a cannula. Optionally, the cannula is a 5 mm-7 mm cannula. Optionally, device  1200  dimensions are adapted for a particular intended use. 
         [0110]    In some exemplary embodiments, device  1200  is inflated and/or implanted as described herein with respect to prostheses  100 ,  202 ,  902 . Device  1200  optionally contains pharmaceutical agents, for example anti-inflammatory drugs and/or antibiotics and/or pro-angiogenesis factors to promote healing, which are eluted into the body. In some embodiments of the invention, device  1200  is adapted to elute pharmaceutical agents according to a predefined schedule. Adaptation of device  1200  includes construction of device  1200  using materials or combinations of materials which degrade at a predetermined rate, thereby releasing pharmaceutical agents contained therein at a predetermined rate. In an exemplary embodiment of the invention, more than one device  1200  is used for treating inflammation and/or infection. Optionally, each device is adapted to elute pharmaceutical agents in view of an overall plan incorporating a plurality of devices. 
         [0111]    In another exemplary embodiment of the invention, an expandable device, such as those described herein, is adapted to be used near an articulation to reinforce the articular capsule. In an embodiment of the invention, the expandable device is introduced in anterior fashion to the shoulder articulation between the articular capsule and the deltoid and pectoralis muscle, in order to prevent recurrent dislocation of the shoulder. In another embodiment, the expandable device is introduced in front of the hip joint capsule to prevent anterior dislocation of the hip, especially in cases of congenital dysplasia of hip. In an exemplary embodiment of the invention, the expandable device consists of in inflatable member made of biocompatible and/or biodegradable material. In some embodiments of the invention, the expandable device has a diameter of 1 cm to 7 cm in the long direction (x-axis) and 1 cm to 5 cm in the short direction (y-axis) with a height (z-axis) of 0.5 mm to 25 mm. Optionally, the device has a height of 3 mm to 15 mm. 
         [0112]      FIG. 13  shows a perspective view of a device  1300  for treating depressed fractures, for example osteoporotic fractures of the vertebra, in accordance with an exemplary embodiment of the invention. In some exemplary embodiments of the invention, device  1300  comprises at least two separately expandable sections, an inner section  1302  and an outer section  1304 . In an embodiment of the invention, at least one expandable section is inflatable. In some embodiments of the invention, inner section  1302  when inflated takes a cylindrical shape measuring approximately 2 to 7 cm in diameter and 2 to 5 cm in height. Optionally, inner section  1302  is larger or smaller depending on the intended use of device  1300  and/or the particular needs of the patient Inner section  1302  is manufactured from materials such as polyurethane, ultra high molecular weight polyethylene (“Spectra®”) and/or Kevlar® and/or any reinforced material that can withstand expected pressures on device  1300  as a result of the intended use, in an embodiment of the invention. In some embodiments of the invention, inner section  1302  is manufactured from a biocompatible and/or biodegradable substance such as PCL, PGA, PHB, plastarch material, PEEK, zein, PLA, PDO and PLGA, collagen, methyl cellulose, or any combination and/or family members thereof. 
         [0113]    Expandable outer section  1304  at least partially surrounds inner section  1302 , in an exemplary embodiment of the invention. In some embodiments of the invention, external section is a sponge-like structure, for example like other sponge-like structures described herein. Optionally, outer section  1304  is an inflatable structure, for example like other inflatable structures described herein. In some exemplary embodiments of the invention, outer section  1304  resembles a hollow cylinder, wheel and/or torus. In some embodiments of the invention, outer section  1304  is made of a biocompatible and/or biodegradable material, such as those described herein and known to those in the art. 
         [0114]    In an embodiment of the invention, inner section  1302  and outer section  1304  are operatively connected to separate inflation devices. Optionally, only one inflation device is needed, for example if outer section  1304  or internal section  1302  is a sponge-like structure. In some exemplary embodiments of the invention, components of device  1300  are removably attached to at least one inflation device such as described elsewhere herein. 
         [0115]      FIG. 14  is a perspective view, with a cutaway side view of two vertebrae  1402 ,  1404 , of a device  1300  for treating depressed fractures of a vertebra in vivo, in accordance with an embodiment of the invention. In some embodiments of the invention, device  1300  is adapted to treat osteoporotic fractures of vertebrae. As described below, device  1300  is used to deploy a filler, for example cement, to act as a force for restoring the natural shape of the fractured vertebra, thereby relieving pain and restoring at least a modicum of function to the patient. 
         [0116]      FIG. 15  is a flowchart  1500  showing a method of treating depressed fractures, in accordance with an exemplary embodiment of the invention. In an exemplary embodiment of the invention, device  1300  is introduced ( 1502 ) to an implantation area using fluoroscopic, CT, MRI and/or TX guidance. Using a cannula, device  1300  is passed ( 1504 ) into vertebra  1402  whereby the depressed fracture is concave in relation to the implantation area, in an embodiment of the invention. An external sheath (similar in form and function of external sheath  802 ) of device  1300  is removed ( 1506 ) and inner section  1302  is inflated ( 1508 ) with a biocompatible filler until the bone regains its intended shape, in an embodiment of the invention. Outer section  1304  is then inflated ( 1510 ) and internal section  1302  is deflated and optionally withdrawn ( 1512 ) from the implantation area, in an embodiment of the invention. In an embodiment of the invention, the bone whose fracture has been reduced is reinforced by filling ( 1514 ) the cavity left in external section  1304  by optional withdrawal ( 1512 ) and/or deflation of inner section  1302  with at least one biocompatible and/or biodegradable filler, for example a cement. In an exemplary embodiment of the invention, outer section  1304  is deflated ( 1516 ) and optionally removed, any implantation devices remaining in use are removed ( 1518 ) and the patient is closed ( 1520 ). Alternatively, outer section  1304  is sealed ( 1522 ) in an inflated state, for example as described herein with respect to other embodiments, and remains in place permanently or until it biodegrades. 
         [0117]    Referring to  FIG. 16 , a cutaway side view of a prosthetic inflation and/or implantation device  1600  is shown, in accordance with an exemplary embodiment of the invention. Prosthesis inflation and/or implantation device  1600  includes a grip  1602  adapted to be grasped in one hand by a medical professional performing the implantation procedure, in an embodiment of the invention. In some embodiments of the invention, device  1600  includes a housing  1604  adapted to mount therein a device inflation mechanism, for example a syringe  1606  comprising at least a canister  1608  and a plunger  1610 , plunger  1610  adapted to travel within canister  1608  and expel filler out of canister  1608  via an outlet  1612  and into tube  204 , described above. In an embodiment of the invention, syringe  1606  is adapted to hold and/or inject 5-20 cc of filler. It should be noted however, that syringe  1606  is adapted to hold and/or or inject more or less filler depending on the intended application of syringe  1606  and/or needs of the patient. In some embodiments of the invention, device  1600  includes a compression assembly  1614  adapted to apply force for at least for advancement of plunger  1610  in canister  1608  upon activation of a trigger  1616 . Additionally and/or optionally, compression assembly  1614  is adapted to apply force for retraction of plunger  1610 . In some embodiments of the invention, device  1600  is used to direct a prosthesis into an implantation site, as the prosthesis is removably connected to device  1600  via tube  204 . 
         [0118]    Referring to  FIG. 17 , a cutaway side view of an alternate prosthetic inflation and/or implantation device  1700  is shown, in accordance with an exemplary embodiment of the invention. In contrast to device  1600 , which advances and/or retracts plunger  1610 , device  1700  is adapted to advance and/or retract a canister  1702  portion of a syringe  1704  with a plunger  1706  portion remaining relatively fixed in relation to device  1700 . Plunger  1706  portion is provided with counterforce, as canister  1702  portion is moved towards a proximal end  1708  of device  1700 , by a backstop  1710 , in an embodiment of the invention. Backstop  1710 , in some exemplary embodiments of the invention, is fixed to device  1700 . In an embodiment of the invention, the placement of the backstop is according to a predetermined level of desired inflation of the prosthesis. 
         [0119]    In an embodiment of the invention, device  1700  is provided with a safety  1712  at least to prevent over-inflation of a prosthesis attached thereto. Safety  1712  in some embodiments of the invention, is comprised of a ball  1714  and a spring  1716  whereby ball  1714  and backstop  1710  are adapted to be counterparts such that ball  1714  releasably fits into a groove on backstop  1710  shaped to receive ball  1714 . In an embodiment of the invention, once canister  1702  is advanced maximally by depressing a trigger  1718 , further force on trigger  1718  will cause safety  1712  to disengage backstop  1710  as a result of ball  1714  popping out of the groove on backstop  1710  as backstop  1710  moves towards proximal end  1708  under the effect of further force. It should be noted that once safety  1712  has disengaged backstop  1710  and therefore, syringe  1704  is no longer being provided with a counterforce, continued depressing of trigger  1718  results in at least a partial retraction of tube  204  and appurtenant parts. In an embodiment of the invention, device  1700  is adapted to be used by one hand of an attending medical professional. 
         [0120]    The present invention has been described using detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. The described embodiments comprise different features, not all of which are required in all embodiments of the invention. Some embodiments of the present invention utilize only some of the features or possible combinations of the features. Variations of embodiments of the present invention that are described and embodiments of the present invention comprising different combinations of features noted in the described embodiments will occur to persons of the art. When used in the following claims, the terms “comprises”, “includes”, “have” and their conjugates mean “including but not limited to”. The scope of the invention is limited only by the following claims.