US-12622787-B2 - Prosthetic devices

US12622787B2US 12622787 B2US12622787 B2US 12622787B2US-12622787-B2

Abstract

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. In one embodiment, a prosthesis includes an implant having a pressure regulating valve. The implant is capable of being positioned between a first tissue and an opposing second tissue in a void space and of deforming under pressure in response to articulation of a joint. The pressure regulating valve is configured to open based on a predetermined pressure in the implant.

Inventors

Shaul Shohat

Assignees

STRYKER EUROPEAN OPERATIONS LIMITED

Dates

Publication Date: 20260512
Application Date: 20231020

Claims (20)

1 . A surgical system, comprising: an inflatable implant; and a surgical instrument that is manipulatable and actuatable as a single instrument, the instrument including: a handle; a shaft extending distally from the handle; a sheath positioned about at least a portion of the shaft, the sheath coupled with and movable relative to the shaft to selectively maintain the inflatable implant in a collapsed position, the inflatable implant releasably secured to a distal end of the shaft; a fluid passage extending through at least a portion of the handle and the shaft; and a user-engageable mechanism on the handle configured to release the inflatable implant from the distal end of the shaft.
2 . The system of claim 1 , wherein, in an implantation position, the sheath is positioned about the inflatable implant, and in a deployment position, the sheath is positioned proximal to the inflatable implant.
3 . The system of claim 1 , wherein the inflatable implant is positioned on a distal end of the shaft and the sheath is slidable along at least a portion of the shaft such that, in an implantation position, the sheath is positioned about a distal end of the shaft, and in a deployment position, the sheath is positioned proximal to the distal end of the shaft.
4 . The system of claim 1 , wherein, while attached to the shaft, in an implantation position, the inflatable implant is deflated and in a rolled position, and in a deployed position, the inflatable implant is inflated and unrolled.
5 . The system of claim 1 , wherein, while attached to the shaft, the inflatable implant includes a deflated position having a shape of a double inward roll.
6 . The system of claim 1 , wherein, the user-engageable mechanism on the handle is configured to release and seal the inflatable implant releasably secured to the distal end of the shaft.
7 . The surgical system of claim 1 , further comprising a safety mechanism, wherein when the safety mechanism is in contact with the user-engageable mechanism, the user-engageable mechanism cannot move, and when the safety mechanism is disengaged from the user-engageable mechanism, the user-engageable mechanism can move.
8 . The surgical system of claim 7 , wherein the user-engageable mechanism is movable to release the implant from the shaft and seal the inflatable implant by eliminating a fluid communication between the inflatable implant and the fluid passage.
9 . The surgical system of claim 1 , wherein a length of the sheath is less than the length of the shaft, the sheath slidable along at least a portion of the length of the shaft.
10 . The surgical system of claim 1 , wherein the sheath comprises a proximally positioned sheath handle, the sheath handle defining an interface to facilitate manual manipulation of the sheath to move the sheath relative to the shaft.
11 . The surgical system of claim 1 , wherein the shaft comprises a stopper extending distally from the handle and a needle extending distally from the stopper, the needle releasably secured to the inflatable implant.
12 . The surgical system of claim 11 , wherein the user-engageable mechanism is movable to promote movement of the needle toward the stopper to release the inflatable implant from the needle.
13 . The surgical system of claim 11 , wherein the user-engageable mechanism is movable to promote axial movement of the needle within the stopper, the movement of the needle to promote movement of an implant port sealing component to seal the implant releasably secured to the needle.
14 . The surgical system of claim 1 , wherein the collapsed position is a rolled configuration.
15 . A method of implanting an inflatable implant within an anatomy of a patient, comprising: obtaining the inflatable implant positioned on a distal end of a shaft of a surgical instrument, the shaft extending proximally to a proximal handle including a user-engageable mechanism to selectively secure or release the implant, the surgical instrument further including a fluid passage extending through at least a portion of the shaft and in fluid communication with the implant, and a sheath coupled to and movable about at least a portion of the shaft, the sheath movable relative to the shaft between a first configuration and a second configuration, where in the first configuration the sheath maintains the inflatable implant in a collapsed position and the sheath and the inflatable implant are insertable into a space of a joint, and in the second configuration the sheath is positioned toward a proximal end of the shaft and at least a portion of the inflatable implant is outside of the sheath; inserting the distal end of the shaft, the sheath, and the inflatable implant into the patient and relative to the anatomy in the first configuration; withdrawing the sheath from the first configuration to the second configuration; inflating the implant by passing an inflation material through the fluid passage and into the implant; and actuating the user-engageable mechanism to release the implant from the shaft.
16 . The method of claim 15 , wherein prior to withdrawing, the inflatable implant is in a deflated position and is positioned within the sheath having a shape of a double inward roll, wherein during inflating the implant unrolls and inflates.
17 . The method of claim 15 , the surgical instrument further comprising a safety mechanism selectively in contact with the user-engageable mechanism, wherein the user-engageable mechanism is configured to move, wherein when the safety mechanism is in contact with the user-engageable mechanism, the user-engageable mechanism cannot move, and when the safety mechanism is disengaged from the user-engageable mechanism, the user-engageable mechanism can move.
18 . The method of claim 17 , wherein actuating the user-engageable mechanism includes moving the user-engageable mechanism to release the implant from the shaft.
19 . The method of claim 15 , wherein actuating the user-engageable mechanism includes sealing the inflatable prosthesis by eliminating fluid communication between the inflatable implant and the fluid passage.
20 . A surgical system, comprising: an inflatable implant; and a surgical instrument, including: a handle; a shaft extending distally from the handle; a sheath positioned about at least a portion of the shaft, the sheath coupled with and movable relative to the shaft to selectively maintain the inflatable implant in a collapsed position, the inflatable implant releasably secured to a distal end of the shaft; a fluid passage extending through at least a portion of the handle and the shaft; and a user-engageable mechanism coupled with the handle, the user-engageable mechanism actuatable between a first position to maintain the implant at the distal end of the shaft and a second position to release the inflatable implant from the distal end of the shaft.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 17/015,748, filed on Sep. 9, 2020, which is a continuation of U.S. application Ser. No. 15/684,881, filed on Aug. 23, 2017, which is a continuation of U.S. application Ser. No. 15/076,109, filed on Mar. 21, 2016 (now U.S. Pat. No. 9,770,337), which is a divisional of U.S. application Ser. No. 14/352,614, filed on Apr. 17, 2014 (now U.S. Pat. No. 9,289,307), which is a national phase filing under 35 U.S.C. 371 of International Application No. PCT/IB2012/002088, filed on Oct. 18, 2012, which claims the benefit of U.S. Provisional Application No. 61/548,232. The entirety of the disclosures of the prior applications are herein incorporated by reference. FIELD OF THE INVENTION 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 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. Severe or complete tears and deterioration of articulations (i.e., bodily joints) related tissues (such as tendons, ligaments, capsules, cartilage and bony parts), and other bodily elements (such as bursae, synovium and other membranes) may cause severe pain, hindered movement up to complete disability, joint parts dislocation, and other possible phenomena. Some joints related deteriorations can be amended by filling voids and spaces between tissues with volumetric fillers especially in scenarios where there is a need to create or revive unhindered relative motion between such tissues. Such volumetric fillers should possess specific combined characteristics such as 3D geometry, external surface texture and overall consistency in order to avoid inefficacy on the one hand and stiff sensation on the other. Since that patients differ much on such voids geometries, mechanical and physical properties of voids' boundaries, and overall shoulder consistency, weight and strength, it is therefore needed that the volumetric fillers will be patient-specific in the sense that it will be deployed, shaped and fine-tuned in vivo. BRIEF SUMMARY OF THE INVENTION In some embodiments, the present invention includes a method of implanting a prosthesis in a body that includes at least the following steps: providing a prosthesis that includes at least an implant capable of deformation under pressure; inserting the implant in a void space in a joint; inflating the implant by adding a first amount of filler to the implant where the first amount of filler is X; articulating the joint; releasing a second amount of filler from the implant where the second amount of filler released from the implant is Y; and sealing the implant where X is greater than Y. In some embodiments, inflating the implant by adding a first amount of filler causes the implant to fully expand, fully unroll, and/or expand a void to a predetermined shape and/or size. In some embodiments, the articulating the joint step and the releasing a second amount of filler from the implant where the second amount of filler released from the implant is Y step occur concomitantly. In some embodiments, the releasing a second amount of filler from the implant where the second amount of filler released from the implant is Y step is caused by the articulating the joint step. In some embodiments, the method includes the implant having a first face and an opposing second face, where the method further includes articulating the joint to result in a predetermined distance between the first face of the implant and the opposing second face of the implant, where the predetermined distance between the first face of the implant and the opposing second face of the implant is greater than 0 millimeters. In some embodiments, the ratio of X:Y is less than or equal to 4:1. In some embodiments, the ratio of X:Y is less than or equal to 2:1. In some embodiments, the ratio of X:Y is less than or equal to 1.3:1. In some embodiments, the implant is a bladder. In some embodiments, the implant is formed of a biodegradable material. In some embodiments, the implant is formed of a biodegradable material that may include polycaprolactone, polyglycolide, polyhydroxybutyrate, plastarch material, polyetheretherketone, zein, polylactic acid, polydioxanone, poly(lactic-co-glycotic acid), poly(lactice aci