WO2023029761A1

WO2023029761A1 - Prosthesis protection device and rotator cuff prosthesis system

Info

Publication number: WO2023029761A1
Application number: PCT/CN2022/105199
Authority: WO
Inventors: 赵金忠; 常兆华; 蒋佳; 康育豪; 刘琛; 岳斌; 葛亮
Original assignee: 上海竞捷医疗科技有限公司; 上海市第六人民医院
Priority date: 2021-09-01
Filing date: 2022-07-12
Publication date: 2023-03-09
Also published as: CN113749817A

Abstract

A prosthesis protection device (100) and a rotator cuff prosthesis system, comprising a protective housing (10). The protective housing (10) has an inner cavity (110) capable of accommodating a rotator cuff balloon (200) in an expanded state and an opening (120) communicated with the inner cavity (110); the opening (120) is used for the rotator cuff balloon (200) to enter the inner cavity (110) only in a compressed state; the outer surface of the protective housing (10) is provided with a connecting portion (20), and the connecting portion (20) is used for directly or indirectly connecting the acromion or humerus.

Description

Prosthetic guards and rotator cuff prosthetic systems

This application claims the priority of the Chinese patent application with the title of "prosthesis protection device and rotator cuff prosthesis system" filed by the applicant on September 1, 2021, and the application number is 2021110225213, which is hereby incorporated in its entirety as refer to.

technical field

The invention relates to the technical field of medical devices, in particular to a protective device for an implanted rotator cuff balloon and a rotator cuff prosthesis system with the protective device.

Background technique

The rotator cuff is the muscle-tendon structure that connects the scapula to the humerus and is located on the outer layer of the shoulder joint capsule and the inner layer of the deltoid muscle. The rotator cuff is composed of anterior rotator cuff (subscapularis), upper rotator cuff (supraspinatus and infraspinatus), and posterior rotator cuff (infraspinatus and teres minor). The function of external rotation and abduction, the more important function is to stabilize the position of the humeral head on the glenoid during activities, maintain the muscle moment arm, and avoid the pain caused by the upward movement of the humeral head and impact on the acromion. Therefore, the rotator cuff plays an extremely important role in maintaining the stability of the shoulder joint and in the process of shoulder joint movement.

However, with age, long-term repeated shoulder joint activities, subacromial bone hyperplasia, or repeated violent activities may cause wear and tear of subacromial soft tissues (joint bursa, rotator cuff), making the humerus The stability and mobility of the shoulder joint are impaired, and the patient's arm cannot be abducted or raised during the shoulder joint movement, and severe pain is caused by the impact between the bone or the bone and the rotator cuff, which will also cause the patient to suffer from pain. Insomnia at night seriously affects the quality of life and self-care ability.

The current treatment methods for rotator cuff injuries mainly include partial rotator cuff repair, rotator cuff reconstruction, local muscle transfer, upper joint capsule reconstruction, and reverse shoulder joint replacement. For mild rotator cuff injuries, general surgery can obtain good results, but for injuries larger than 3 cm, the surgical effect is not clear and recurrence is easy. In recent years, a new treatment method has been practiced, using the implantation of prosthesis (rotator cuff balloon) to artificially limit the upward movement of the humerus, avoiding the pain caused by the impact between tissues, and further increasing the force arm of the deltoid muscle , to immediately improve the function of the patient's shoulder joint.

However, the rotator cuff balloon is prone to slippage when the shoulder joint moves frequently and greatly, causing pain and discomfort to the patient, and even the risk of product failure and the need for secondary surgery to remove it. Moreover, due to the movement characteristics of the shoulder joint, the mechanical properties of the rotator cuff balloon are required to be high, and it is required to have better resistance to bone spurs, wear resistance and pressure bearing capacity, otherwise it will affect the performance of the rotator cuff balloon. service life.

Aiming at this problem, a solution to fix the balloon is proposed in the related art. For example, the patent CN209734178U discloses a fixed inflatable balloon, the interior of the balloon is provided with an adjustable inflatable cavity, and the proximal and distal ends of the balloon are provided with sutures for fixing the balloon. The disadvantage of this fixation solution is that a special structural design needs to be made on the balloon, so that the balloon has a special connection structure with sutures. This special structure on the balloon has the possibility of cutting and damaging the surrounding muscle tissue and being sutured itself. Risk of rupture due to "cutting". In addition, there are too many sutures on the balloon, and there are too many damage points to the surrounding tissue, and it is complicated and time-consuming to fix them one by one during the operation.

Contents of the invention

According to various embodiments of the present application, a prosthetic shielding device is provided.

A prosthetic protective device adapted to an inflatable rotator cuff balloon, the rotator cuff balloon can be in an inflated state filled with a substance and in a compressed state without a substance inflated, comprising:

a shielding housing having a lumen capable of accommodating the rotator cuff balloon in an inflated state and an opening communicating with the lumen for the rotator cuff balloon only in a compressed state Entering the inner cavity, the outer surface of the protective shell has a connecting portion for directly or indirectly connecting the acromion or the humerus.

In one embodiment, the protective shell is an expandable and contractable elastic structure, and the inner cavity expands due to the expansion of the rotator cuff balloon.

In one embodiment, the capsule wall of the protective shell is one or a composite of a membrane structure and a braided structure.

In one embodiment, the suture comprises two free portions exposed outside the protective shell.

In one embodiment, the connection part includes a fixing belt, and the fixing belt is fixedly connected or integrally formed with the protective shell.

In one embodiment, the material of the protective shell and the fixing belt is a biocompatible non-degradable or degradable polymer material.

In one embodiment, the connection point between the fixing belt and the protective shell is deviated from the geometric center of the protective shell.

In one embodiment, the fixing belt is a single suture pierced through the protective shell; or, it is two sutures, and the two sutures are respectively connected to the protective shell and respectively The free portion is provided.

In one embodiment, the surface of the protective shell and/or the connection part has a coating, and the coating is a lubricating layer, a drug layer or a protective layer.

In one embodiment, the protective shell is a grid-like structure woven with braided wires, and the connecting portion includes grid holes of the grid-like structure.

In one embodiment, the protective shell is a deformable elastic structure under external force, and the inner cavity does not expand due to the filling of the rotator cuff balloon.

In one embodiment, the protective shell is a cage-like structure braided by metal wires, and the connecting portion includes holes in the cage-like structure.

In one embodiment, a developing structure is provided on the protective shell.

In one embodiment, the outer surface of the protective shell is provided with a curved surface, a concave or a protruding structure, which is adapted to the acromion or the humerus.

According to various embodiments of the present application, a rotator cuff prosthesis system is proposed, including: the prosthesis protection device of any of the above-mentioned embodiments; a minimum diameter greater than a minimum inner diameter of the opening such that the rotator cuff balloon enters the lumen through the opening in a compressed state and is movably accommodated in the lumen but cannot pass through the lumen in an inflated state. The opening exits the lumen.

In one embodiment, the volume of the internal cavity in the compressed state of the rotator cuff balloon is less than or equal to the volume of the posterior internal cavity in the inflated state of the rotator cuff balloon, and the upper limit of the inflated state of the rotator cuff balloon is The volume is V1, the volume of the inner cavity is V2, wherein V1/V2 is less than 90%.

The details of one or more embodiments of the application are set forth in the accompanying drawings and the description below. Other features, objects and advantages of the present application will be apparent from the description, drawings and claims.

Description of drawings

In order to better describe and illustrate embodiments or examples of those inventions disclosed herein, reference may be made to one or more of the accompanying drawings. Additional details or examples used to describe the drawings should not be considered limitations on the scope of any of the disclosed inventions, the presently described embodiments or examples, and the best mode of these inventions currently understood.

Fig. 1 is a schematic structural diagram of a protective device according to an embodiment;

Fig. 2 is a schematic plan view of the protective housing in the protective device;

Fig. 3 is a three-dimensional schematic diagram of a protective housing in the protective device;

Fig. 4 is a top view of the protective housing shown in Fig. 3;

Fig. 5 is a schematic structural diagram of a protective case according to an embodiment;

Fig. 6 is a schematic structural view of a rotator cuff prosthesis system according to an embodiment;

Fig. 7 is a schematic structural diagram of a protective housing according to another embodiment;

Fig. 8 is a schematic structural diagram of a protective housing according to yet another embodiment;

Fig. 9 is a partial enlarged structural schematic diagram of the protective shell shown in Fig. 8;

FIG. 10 is a partially enlarged structural schematic diagram of the protective case shown in FIG. 9 .

Detailed ways

In order to make the above-mentioned purpose, features and advantages of the present application more obvious and understandable, the specific implementation manners of the present application will be described in detail below in conjunction with the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the application. However, the present application can be implemented in many other ways different from those described here, and those skilled in the art can make similar improvements without departing from the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

Referring to FIG. 1 , an embodiment of the present invention provides a prosthesis protection device 100 . The prosthetic shielding device 100 is particularly adapted for inflatable rotator cuff balloons. As shown in FIG. 6 , it is a schematic plan view of the protective device 100 and the rotator cuff balloon 200 in a coordinated use state, and the two form a rotator cuff prosthesis system. Wherein, in FIG. 6 , the protection device 100 is sleeved on the outside of the rotator cuff balloon 200 , the left half of the figure shows the outside protection device 100 , and the right half shows the inside rotator cuff balloon 200 . The rotator cuff balloon 200 is specifically an inflatable rotator cuff balloon. For the inflatable rotator cuff balloon, it has an internal filling cavity. The inflatable type refers to the use of substances to fill the interior of the rotator cuff balloon to expand the volume of the rotator cuff balloon, so as to be in an inflated state after being filled with substances. The rotator cuff balloon It can be compressed when it is not filled with substances, such as compressed by curling, so as to be in a compressed state without being filled with substances. The substance may be fluid, gas or solid; preferably a fluid, and the fluid may specifically be physiological saline. After the rotator cuff balloon 200 is implanted between the acromion and the humerus, it can be filled with substances. The implantation of the rotator cuff balloon 200 can maintain and increase the distance between the acromion and the humerus, thereby directly isolating the torn rotator cuff and preventing The rotator cuff wound collides with the bony structure of the acromion to relieve pain. At the same time, by rebuilding the distance between the acromion and the humerus, the moment arm of the shoulder joint is increased, and the mobility of the shoulder joint is improved. In the embodiment of the present application, the specific structure of the rotator cuff balloon 200 is not limited. For example, the rotator cuff balloon 200 may have a single-layer structure, and the rotator cuff balloon 200 may also have a multi-layer structure. Rotator cuff balloon 200 may be formed by a blow molding process. Alternatively, the multilayers are formed by hot-melt connection or co-blowing of the multilayers.

The protective device 100 is used to be sleeved on the outside of the rotator cuff balloon 200 and fixed to a predetermined position of the shoulder joint, such as the humerus or the acromion. The protective device 100 can fix the rotator cuff balloon 200 to a certain extent, so that the rotator cuff balloon 200 cannot escape from the restraint of the protective device 100 . Meanwhile, the rotator cuff balloon 200 has a relatively movable space in the protective device 100 . Thereby, the fixation of the rotator cuff balloon 200 is ensured, and failure caused by dislocation of the rotator cuff balloon 200 is avoided; the rotator cuff balloon 200 can automatically adapt to the activities of the shoulder joint within the allowable range of activities, and the length of the rotator cuff balloon can be extended. 200 service life. In addition, in the traditional technology, frequent friction between the rotator cuff balloon 200 and the humerus leads to higher requirements on the mechanical properties of the rotator cuff balloon 200 . In the embodiment of the present invention, the protective device 100 is equivalent to the outer protective layer of the prosthesis, which increases the overall mechanical properties (puncture, wear, pressure) of the rotator cuff prosthesis, and at this time the wear resistance of the prosthesis It no longer depends on the balloon so that the mechanical performance requirements of the internal rotator cuff balloon 200 are reduced, and the rotator cuff balloon 200 is allowed to use other materials that do not have good wear resistance, for example, the cost is lower, as long as it can meet the filling requirements. Not a material with good wear resistance.

As shown in FIGS. 1 and 2 , the protective device 100 includes a protective housing 10 having an inner chamber 110 . The outer surface of the shield shell 10 has a connecting portion 20 for connecting directly or indirectly to the acromion or the humerus to connect the shield shell 10 to the acromion or the humerus. As shown in FIG. 1 , FIG. 3 and FIG. 4 , one side of the protective housing 10 has an opening 120 communicating with the inner cavity 110 of the protective housing 10 . The size of the protective shell 10 is adapted to the adapted rotator cuff balloon 200 and is slightly larger than the rotator cuff balloon 200 . Wherein, the size of the opening 120 is set to allow the adapted rotator cuff balloon 200 to pass through in a compressed state, while the rotator cuff balloon 200 cannot enter and exit the inner cavity 110 through the opening 120 when the rotator cuff balloon 200 is inflated with material. Specifically, the minimum cross-sectional diameter of the rotator cuff balloon 200 inflated with material is larger than the minimum inner diameter of the opening 120, so that the rotator cuff balloon 200 cannot enter and exit the inner cavity 110 through the opening 120 after being inflated with material. . The minimum diameter of the cross section here refers to the diameter of the smallest circumscribed circle of the cross section when the cross section is non-circular. When in use, the rotator cuff balloon 200 is placed in a compressed state first and then inserted into the inner cavity 110 of the protective shell 10 through the opening 120, and then the rotator cuff balloon 200 and the protective device 100 are connected together and implanted into the acromion in the shoulder joint cavity. Between the humerus and the rotator cuff balloon 200 , the material is filled to expand the volume of the rotator cuff balloon 200 to the point where it cannot pass through the opening 120 to enter or leave the inner cavity 110 .

When the rotator cuff balloon 200 is placed in the inner cavity 110 and inflated with material, the rotator cuff balloon 200 and the protective shell 10 still have a relatively movable space, so that the rotator cuff balloon 200 is within the allowable range of motion Automatically adapts to the movement of the shoulder joint. Set the upper limit volume of the rotator cuff balloon 200 after being inflated with material to be V1, the volume of the inner cavity 110 is V2, and V2 is greater than V1, so that the inner cavity 110 can provide for the movement of the rotator cuff balloon 200 after being filled with material The activity space, preferably V1/V2 is less than 90%. Therefore, the protective shell 10 plays a restrictive role on the rotator cuff balloon 200; at the same time, the range of the above-mentioned volume ratio is relatively moderate, allowing the rotator cuff balloon 200 to move within a suitable range to automatically adapt to the movement of the shoulder joint. In practical application, the above-mentioned volume V1 can be measured by the drainage method, so as to determine the amount of the substance that needs to be filled into the rotator cuff balloon 200 . When the rotator cuff balloon 200 is placed in the inner cavity 110 , the substance can be filled into the rotator cuff balloon 200 according to the above measurement results.

The protective shell 10 can be arranged in various forms. For example, the protective shell 10 is an expandable and contractible elastic structure, that is, the protective shell 10 has a certain elastic deformation capability, and the volume of the inner cavity 110 expands due to the expansion of the rotator cuff balloon 200 . That is, the volume of the inner cavity 110 before the rotator cuff balloon 200 is filled with the material is smaller than the volume of the inner cavity 110 after the rotator cuff balloon 200 is filled with the material. Specifically, when the rotator cuff balloon 200 in the inner cavity 110 is not filled with material, the protective housing 10 is in a contracted state under the action of elastic force, and the volume of the inner cavity 110 is relatively small. When the rotator cuff balloon 200 is inflated by material filling, the inner cavity 110 expands together and the volume V2 of the activity space provided after expansion is greater than the upper limit volume V1 of the rotator cuff balloon 200 in the inflated state after being filled with material, preferably Ground V1/V2 is less than 90%. Therefore, the shape of the protective shell 10 can be changed to automatically adapt to different shapes of rotator cuff prostheses and tissues in the shoulder joint. During specific manufacture, the capsule wall of the protective shell 10 includes at least one layer of structure. As shown in Figure 5, each layer structure of the capsule wall can be a braided structure braided by braided wires, or a membrane structure made of a thin film; or a composite of a braided structure and a membrane structure. Preferably, the capsule wall has a structure of more than two layers. The multilayer film also enhances the puncture resistance of the balloon. The braided structure can also effectively improve the strength of the balloon and enhance the puncture resistance of the balloon.

In addition, the protective shell 10 can also be a non-shrinkable structure. The non-shrinkable structure here refers to the volume of the inner cavity 110 of the protective shell 10 under normal conditions (without external force), which is larger than that of the rotator cuff balloon 200 after being filled with material. The volume, that is, the lumen 110 of the protective housing 10 is not expanded due to the expansion of the rotator cuff balloon 200 . Similarly, when the protective shell 10 is a non-contractable structure, the rotator cuff balloon 200 can enter the protective shell 10 through the opening 120 when it is in a compressed state. The rotator cuff balloon 200 is in the inner cavity 110 and cannot exit the inner cavity 110 from the opening 120 after being filled with material, and the rotator cuff balloon 200 can move in the inner cavity 110 . On this basis, the protective shell 10 can still have a certain ability of elastic deformation when subjected to external force. Therefore, when the protective shell 10 is implanted into the human body together with the rotator cuff balloon 200, the protective shell 10 can also be changed in shape to automatically adapt to different shapes of rotator cuff prosthesis and shoulder joint internal tissue.

The outer surface of the protective shell 10 can be provided with a curved surface, a concave or a protruding structure for adapting to the acromion or the humerus, so that the protective shell 10 can better fit the tissues in the shoulder bee. The above-mentioned curved surface, concave or protruding structure can be provided on the upper and lower surfaces or the left and right end surfaces of the protective shell 10 in FIG. 1 .

The protective case 10 may also have developability. Since the rotator cuff balloon 200 is placed in the protective shell 10, the position of the protective shell 10 in the human body can indicate the position of the rotator cuff balloon 200 in the human body. The protective shell 10 has visualization properties, which is beneficial to check the suitability of the implantation position, filling and expansion state of the rotator cuff balloon 200 in the shoulder joint cavity by means of X-ray during the operation. In the embodiment of the present application, a development structure is provided on the outer surface of the protective shell 10 or in the capsule wall. The development structure is made of a development material such as metal, metal oxide or metal salt. The development material can be selected from BaSO4, Bi2O3, One or more combinations of developing materials such as (BiO)2CO3, BiOCl, W, WC, Mg, Fe, Nd, Zn and Zr. In particular, when the protective shell 10 is made of biodegradable medical polymer materials, the developing structure is made of one or more combinations of biomedical degradable metal materials such as magnesium-based, zinc-based and iron-based materials. Optionally, the developing structure is in the form of dots, blocks or flakes, and the present application does not specifically limit the shape of the developing structure. Preferably, there are multiple developing structures.

Referring to FIG. 1 and FIG. 5 , in an example, the connecting portion 20 on the outer surface of the protective case 10 is specifically a fixing belt. The number of fixing belts can be one or more. Both the protective shell 10 and the seam fixing belt are made of biocompatible ultra-high polymer materials and formed by a fiber weaving process, which can provide the protective shell 10 with excellent mechanical properties such as compressive strength, abrasion resistance, and suture strength. Excellent breaking strength is provided, and excellent connection strength is provided between the protective shell 10 and the fixing belt. Biocompatible materials can be non-biodegradable materials such as polyolefin, polyester, polyamide, polyvinyl chloride, nylon elastomer, polyurethane, rubber, or a mixture or composite of two or more of these materials Material. Generally, biodegradable medical polymer materials can be selected from biological materials such as polylactic acid, polycaprolactone, polylactide-caprolactone copolymer, polypeptide, polyamino acid, poly 3-hydroxyalkanoate, chitin, and PBS. Degradable materials, or choose a mixture or composite of two or more of these materials. The fixing belt is formed by a fiber weaving process. The fixing belt can be made of multi-strand fiber weaving or single-strand fiber. The cross-sectional shape of the fixing belt includes but is not limited to flat, round or semicircular. Generally, the mechanical properties of the fixing belt should meet the following requirements: the tensile (breaking) capacity is above 100N, that is, the pulling force less than 100N will not cause the fixing belt to break, so that it can meet the needs of large-scale activities of the shoulder joint.

The fixing belt and the protective shell 10 can be fixedly connected or integrally formed. For example, during fixed connection, the fixing belt can be sewn on the protective shell 10 . For integral molding, the above-mentioned fixing belt may be formed at the same time when the protective shell is formed by a weaving process. When the fixation belt is connected to the acromion, it can be connected by suturing. When the fixation belt is connected with the humerus, a bone hole can be drilled on the acromion first, and then the fixation belt can be put through the bone hole. Then tie the fixing belt passing through the drill hole under the skin or on the body surface to form an overall structure that suspends the prosthesis in the subacromial gap, thereby effectively fixing the prosthesis at the expected position.

As shown in FIG. 1 , in an example, the fixing strap has two free parts 220 , and the two free parts 220 can be respectively used to connect with the acromion and the humerus. For example, the number of fixing belts is two, specifically two sutures, and the two free parts 220 are respectively provided on one fixing belt. Therefore, the two fixing straps are respectively connected to the protective shell 10 , and the free parts 220 of the two fixing straps are respectively used to connect with the acromion and the humerus, which is convenient for doctors to operate, and the fixation of the protective shell 10 is more reliable. For another example, the fixing belt is a single suture threaded through the protective shell 10 , which includes two free portions 220 exposed outside the protective shell 10 . The part of the fixing belt passing through the protective shell 10 can be fixedly connected or relatively movably connected with the protective shell.

The strap surface may or may not have a coating. In a fixed tape with a coating, the coating may be composed of a single component or a multicomponent, single layer or multilayer structure, in the form of including but not limited to a lubricating layer, or a protective layer to prevent the unraveling of multiple strands of fibers, or to promote wound healing. Healing drug layer, or multilayer drug layer structure for controlled drug release. Wherein, the lubricating layer can reduce the friction between the fixing belt and the humerus, slow down wear and prolong the service life of the fixing belt. For example, the lubricating layer can be polyvinylpyrrolidone (PVP), polytetrafluoroethylene (PTFE), silicone oil coating and the like. The protective layer can bind the multi-strand fibers inside, prevent the multi-strand fibers from spreading, and ensure the strength of the fixing belt. For example, the protective layer may be polyvinylpyrrolidone (PVP), polyacrylamide, or the like. The drug layer can be in contact with human tissues and body fluids, thereby promoting wound healing. For example, the drug layer includes at least one of the following drugs: diclofenac diethylamine, fentanyl and the like. When a multi-layer drug layer structure is provided, the release speed of each drug layer is different, thereby realizing periodic release. Similarly, the above-mentioned coating can also be provided on the surface of the protective shell 10 .

As shown in Figure 1, the fixing belt, that is, the connection point 210 between the connecting part 20 and the protective shell 10 deviates from the geometric center A of the protective shell 10, so that the purpose is to adapt to the spatial distribution of the human body's acromion and the design of the bone size, and to deal with the rotator cuff of different groups of people. The inner structure or the different symmetrical structures of the left and right shoulders, so as to better fit the tissues in the rotator cuff. The connection point 210 here should be understood as a joint area in a small range, and the fixing belt is connected to the protective shell 10 in a relatively limited small range. Visually, it appears that the junction between the fixing belt and the protective shell 10 is in the form of dots instead of lines. As shown in FIG. 1 , the two connection points 210 between the two fixing straps and the protective shell 10 are both biased to the right of the geometric center A of the protective shell 10 . In addition, the connection point 210 between the two fixing straps and the protective case 10 can be symmetrically located at the geometric center A of the protective case 10, so that the traction force of the two fixing straps acting on the protective case 10 is symmetrical to the geometric center A of the protective case 10, The inner cavity 110 is in a relatively stable state, which is beneficial for the inner cavity 110 to constrain the rotator cuff balloon 200 within a predetermined activity space.

As shown in FIG. 1 to FIG. 3 , in an example, the protective housing 10 has a flat and approximately circular shape as a whole. As shown in FIG. 6 , the shape of the rotator cuff balloon 200 is consistent with the shape of the protective shell 10 . As shown in FIG. 1 , the dimension L1 of the opening 120 of the protective case 10 is 0-70 mm, preferably 15-30 mm. The above range of L1 can be better adapted to the protective balloon sheath in the delivery system. The protective shell 10 can be sleeved on the protective balloon sheath, so that the balloon inside the protective balloon sheath enters the protective shell 10 under the drive of the driving mechanism.

The length L3 of the protective shell 10 should be slightly longer than the length of the adapted rotator cuff balloon 200. Taking the length of the rotator cuff balloon 200 as 60 mm as an example, the length L3 of the protective shell 10 is preferably 60-80 mm. The width L4 should be slightly larger than the width of the adapted rotator cuff balloon 200. Taking the rotator cuff balloon 200 with a width of 60mm as an example, the width L4 should be 60-80mm. The protective shell 10 is not limited to the above-mentioned flat and approximately circular shape, and any shape capable of accommodating the adapted rotator cuff balloon 200 can be used to realize the embodiments of the present application.

There are two fixing straps, and the two fixing straps and the protective housing 10 respectively have a connection point 210 . The two connection points 210 are arranged at intervals in the width direction of the protective case 10 , and both are located on the right side of the geometric center A of the protective case 10 . The distance L2 between the two connection points 210 may be 0-70 mm, preferably 5-30 mm. The connection point 210 has a height L6 on the protective shell 10 . The height position of the connection point 210 on the protective case 10 refers to the distance from the connection point 210 to the edge of the protective case 10 . There is no limit to height L6. Preferably, the height L6 is half of the length L3 of the protective case 10 . The aforementioned ranges of L2 and L6 allow the connection point 210 to align with the position of the acromial bones of the human body, and then make the position of the protective shell 10 conform to the physiological and anatomical configuration. The length L5 of the free portion 220 of the fixing strap is not particularly limited. However, the free part 220 is used to connect with the humerus and the tendon, and the doctor needs to operate the fixation belt in the shoulder joint cavity for suturing and fixing during the operation, so there is less room for expansion. An excessively long fixing belt will cause the doctor to operate the instrument when suturing, and the excess thread ends after suturing and fixing are relatively long. Therefore, for the convenience of doctors to operate, L5 is preferably set to 100-1000mm.

The protective shell 10 can also be a deformable elastic structure when subjected to external force, and the inner cavity 110 does not expand due to the expansion of the rotator cuff balloon 200 . Specifically, the protective shell 10 also has a certain degree of elasticity, but the volume of the inner cavity 110 of the protective shell 10 in a normal state (without external force) is larger than the volume of the rotator cuff balloon 200 after being filled with material, and the protective shell 10 is not Because the rotator cuff balloon 200 expands after being filled with the substance, the volume of the inner cavity 110 is equal before and after the rotator cuff balloon 200 is filled with the substance. After the protective shell 10 and the rotator cuff balloon 200 are implanted together, the protective shell 10 also has a certain deformation ability when subjected to external force, so that the shape can also be changed within a certain range to automatically adapt to different shapes of the rotator cuff prosthesis and tissues within the shoulder joint. For example, as shown in FIG. 7 , the protective shell 10 may also be a cage-shaped structure braided by metal wires. The metal wire is preferably made of titanium or titanium alloy, which has less impact on the human body. When the cage structure is formed, many holes 131 of different sizes are formed. These holes 131 are used for the connection part 20 connected with the humerus. After the protective shell 10 is implanted into the human body, a bone nail can be used to pass through the above-mentioned hole 131, and then cooperate with the bone hole on the humerus. The cage-like structure has the characteristics of holes 131 in its structure, which can change its shape after being subjected to external force. The specific changes are manifested as microscopic changes in the size and shape of the holes 131. Using the changes in the holes 131, it can lead to cage-like structures macroscopically. The shape of the structure as a whole changes. Therefore, the cage-like structure made of metal wires has a certain elastic deformation capacity. When no external force is applied, the inner cavity 110 already has the above-mentioned volume V2, and the shape can still be changed and automatically adapted to different shapes after being implanted in the human body. rotator cuff prosthesis and shoulder joint tissue. In addition, the protective shell 10 is a cage-like structure made of braided metal wires, and at this time the connecting portion 20 may also be a fixing belt as shown in FIG. 1 . Specifically, the fixing strap is attached on the metal wire.

As shown in FIGS. 8 to 10 , the protective shell 10 is a grid-like structure braided by braided wires 140 , and the connecting portion 20 includes the grid 141 of the cage-like structure. The mesh 141 is then used as the connecting portion 20 to the humerus or the acromion. Specifically, a bone nail can be used to pass through the above-mentioned grid 141, and then cooperate with the bone hole on the humerus or the acromion. In this embodiment, the protective shell 10 is also an expandable and contractable elastic structure, and its elastic capacity is based on the elastic capacity of the braided wire 140 itself. The braided wire 140 may be composed of multi-strand fiber braids or single-strand fibers. The material of the braided wire 140 is the same as that of the fixing belt in the foregoing embodiments, and the surface of the braided wire 140 can be provided with the aforementioned lubricating layer, drug layer or protective layer, which will not be repeated here. In addition, the connecting part 20 can also be a fixing belt as shown in FIG. 1 ; thread ends can be reserved as a fixing belt when weaving to form a grid-like structure, or a fixing belt can be separately provided to connect with the protective shell 10 . In addition, the connection part 20 may also be a metal hook, an anchor, etc. fixed on the protective shell 10; further, the connection part 20 may also include two free parts respectively connected to the humerus or the acromion. For example, the metal hook has two free parts, and the two free parts are respectively connected with the humerus or the acromion.

The protective device 100 of the embodiment of the present application is used to fix the rotator cuff balloon 200, prevent the dislocation of the rotator cuff balloon 200, and can enhance the resistance to bone spurs and abrasion of the rotator cuff balloon 200, as well as enhance the pressure bearing capacity , prolong its service life, and continuously improve the range of motion of the shoulder joint. At the same time, the protective device 100 and the rotator cuff balloon 200 together isolate the damaged rotator cuff tissue, prevent the acromion from impinging on the rotator cuff tear wound and the bone tissues in the acromion from colliding with each other, thereby relieving the pain of the patient, and at the same time rebuilding the humeral head and The distance between the acromion can immediately improve the range of motion of the shoulder joint, help it to carry out early rehabilitation training, and reduce the occurrence of adverse events such as foreign body sensation, prosthesis dislocation, and functional failure in patients.

The present invention also provides a rotator cuff prosthesis system, as shown in FIG. 6 , comprising the protective device 100 and the rotator cuff balloon 200 of any of the above-mentioned embodiments. The rotator cuff balloon 200 enters the lumen 110 from the opening 120 after being compressed. After the rotator cuff prosthesis system is implanted into the shoulder joint cavity, the rotator cuff balloon 200 is inflated and kept in the protective casing 10 by being filled with material. The connecting part 20 of the protective shell 10 of the protective device 100 is directly connected to the humerus or the acromion through bone nails, forming an integral structure that suspends the prosthesis in the subacromial space, thereby effectively fixing the prosthesis at the desired position.

In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", " Back", "Left", "Right", "Vertical", "Horizontal", "Top", "Bottom", "Inner", "Outer", "Clockwise", "Counterclockwise", "Axial" , "radial", "circumferential" and other indicated orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the application and simplifying the description, rather than indicating or implying the referred device or Elements must have certain orientations, be constructed and operate in certain orientations, and thus should not be construed as limiting the application.

In addition, the terms "first" and "second" are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features. Thus, the features defined as "first" and "second" may explicitly or implicitly include at least one of these features. In the description of the present application, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

In this application, terms such as "installation", "connection", "connection" and "fixation" should be interpreted in a broad sense, for example, it can be a fixed connection or a detachable connection, unless otherwise clearly specified and limited. , or integrated; it may be mechanically connected or electrically connected; it may be directly connected or indirectly connected through an intermediary, and it may be the internal communication of two components or the interaction relationship between two components, unless otherwise specified limit. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application according to specific situations.

In the present application, unless otherwise clearly specified and limited, a first feature being "on" or "under" a second feature may mean that the first and second features are in direct contact, or that the first and second features are indirect through an intermediary. touch. Moreover, "above", "above" and "above" the first feature on the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. "Below", "beneath" and "beneath" the first feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is less horizontally than the second feature.

It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or there may be an intervening element. When an element is said to be "connected" to another element, it may be directly connected to the other element or intervening elements may also be present. As used herein, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions are for the purpose of illustration only and are not intended to represent the only embodiment.

The technical features of the above embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, they should be It is considered to be within the range described in this specification.

The above examples only express several implementation modes of the present application, and the description thereof is relatively specific and detailed, but should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the scope of protection of the patent application should be based on the appended claims.

Claims

A prosthetic protective device adapted to an inflatable rotator cuff balloon, the rotator cuff balloon can be in an inflated state after being filled with a substance, and in a compressed state without being filled with a substance, and is characterized in that it includes:

a shielding housing having a lumen capable of accommodating the rotator cuff balloon in an inflated state and an opening communicating with the lumen for the rotator cuff balloon only in a compressed state Entering the inner cavity, the outer surface of the protective shell has a connecting portion for directly or indirectly connecting the acromion or the humerus.
The prosthetic protective device according to claim 1, wherein the protective shell is an expandable and contractable elastic structure, and the inner cavity expands due to the expansion of the rotator cuff balloon.
The protective device for prosthesis according to claim 2, characterized in that, the shell wall of the protective shell is one or a composite of a membrane structure and a braided structure.
The prosthetic protective device according to claim 1, wherein the connecting portion includes two free portions exposed outside the protective shell.
The prosthetic protection device according to claim 1 or 4, wherein the connection part comprises a fixing belt, and the fixing belt is fixedly connected or integrally formed with the protective shell.
The prosthetic protective device according to claim 5, wherein the material of the protective shell and the fixing belt is a biocompatible non-degradable or degradable polymer material.
The prosthetic protective device according to claim 5, wherein the connection point between the fixing belt and the protective shell deviates from the geometric center of the protective shell.
The prosthetic protective device according to claim 5, wherein the fixing belt is a single suture threaded through the protective shell; or, it is two sutures, and each of the two sutures is It is connected with the protective shell and provided with the free parts respectively.
The prosthetic protective device according to claim 1, characterized in that, the surface of the protective shell and/or the connecting part has a coating, and the coating is a lubricating layer, a drug layer or a protective layer.
The prosthetic protective device according to claim 1 or 2, characterized in that, the protective shell is a grid-like structure woven with braided wires, and the connecting portion includes grid holes of the grid-like structure .
The prosthetic protective device according to claim 1, wherein the protective shell is an elastic structure deformable when subjected to external force, and the inner cavity does not expand due to the expansion of the rotator cuff balloon.
The prosthetic protection device according to claim 11, wherein the protective shell is a cage-like structure braided by metal wires, and the connecting portion includes holes in the cage-like structure.
The protective device for prosthesis according to claim 1, characterized in that a developing structure is arranged on the protective shell.
The prosthesis protective device according to claim 1, wherein the outer surface of the protective shell is provided with a curved surface, a concave or a protruding structure, which is adapted to the acromion or the humerus.
A rotator cuff prosthesis system, characterized in that it comprises:

The prosthesis protection device according to any one of claims 1-14;

Inflatable rotator cuff balloon, the cross-sectional minimum diameter of the rotator cuff balloon in the inflated state is larger than the minimum inner diameter of the opening, so that the rotator cuff balloon can enter the inner diameter through the opening in the compressed state lumen, and in an inflated state is movably contained within said lumen but cannot exit said lumen through said opening.
The rotator cuff prosthesis system according to claim 15, wherein the volume of the inner cavity in the compressed state of the rotator cuff balloon is less than or equal to the volume of the posterior inner cavity in the expanded state of the rotator cuff balloon, The upper limit volume of the rotator cuff balloon in the inflated state is V1, the volume of the inner cavity is V2, wherein V1/V2 is less than 90%.