WO2020173401A1

WO2020173401A1 - Prosthesis for shoulder joint and prosthesis device

Info

Publication number: WO2020173401A1
Application number: PCT/CN2020/076240
Authority: WO
Inventors: 岳斌; 刘琛; 季晓飞
Original assignee: 上海竞捷医疗科技有限公司
Priority date: 2019-02-27
Filing date: 2020-02-21
Publication date: 2020-09-03
Also published as: CN109758269A

Abstract

Provided are a prosthesis for shoulder joint and a prosthesis device, the prosthesis is arranged between the acromion (20) and the humeral head (30), a torn rotator cuff can be isolated, a wound on the rotator cuff is prevented from colliding with a bone structure of the acromion (20), pain is thus relieved. Meanwhile, the distance between the shoulder and the humerus is reset to increase the lifting force arm of the shoulder joint, which improves the movement capability of the shoulder joint. The prosthetic device includes a delivery system (40) and the prosthesis, the delivery system (40) is used for delivering the prosthesis to the shoulder joint cavity, so that the prosthesis can be contained between the acromion (20) and the humeral head (30), therefore the distance between the acromion (20) and the humeral head (30) is maintained and/or increased. The prosthesis is an expandable and contractible structure, the prosthesis can be fixed into the shoulder joint cavity through a first surface (11) and/or a second surface (12), the puncture resistance of the prosthesis can be enhanced through a multilayer structure, and the state of the prosthesis after implantation can be observed through a developing structure.

Description

Prostheses for shoulder joints and prosthetic devices Technical field

The present invention relates to the technical field of medical devices, and in particular to a prosthesis and a prosthetic device for the shoulder joint. Background technique

The rotator cuff is a cuff-like tendon complex structure formed by the supraspinatus, infraspinatus, subscapularis, and teres minor tendons in front, upper, and back of the humeral head. It is effective in maintaining the stability of the shoulder joint and exerting extra-articular structures. Normal activity functions such as exhibition and rotation play a vital role. Rotator cuff tear is a common shoulder joint disease in middle-aged and elderly people, most of which are degenerative tendon injuries. The prominent symptoms shown are shoulder joint pain and limited joint movement. Rotator cuff repair surgery has become the most effective method at present, but for severe (large) rotator cuff tears, the current surgical methods may not be directly repaired, or the tear occurs after forced repair, and the surgical effect is still poor.

Therefore, it is necessary to develop a new type of prosthesis to improve the therapeutic effect of rotator cuff repair. Summary of the invention

The purpose of the present invention is to provide a prosthesis and a prosthesis device for the shoulder joint. By placing the prosthesis between the acromion and the humeral head, the torn rotator cuff can be directly isolated to prevent rotator cuff wounds and acromion. The osseous structure produces impact to relieve pain. At the same time, the shoulder-brachial distance is reconstructed, and the moment arm of the shoulder joint is increased to instantly improve the mobility of the shoulder joint. The prosthesis of the present invention is suitable for treating rotator cuff tears and other shoulder tendon injuries, and can be used to assist various shoulder joint surgeries and help improve the mechanical conditions of the shoulder joint after surgery.

To achieve the above objective, the present invention provides a prosthesis for a shoulder joint, which has an expanded configuration and a contracted configuration. Wherein, in an embodiment, the prosthesis for the shoulder joint has a first surface and a second surface that are opposed to each other, and when the prosthesis for the shoulder joint is in an expanded configuration, the first surface It is curved or flat in a direction close to the second surface, and the second surface protrudes in a direction away from the first surface. In another embodiment, the prosthesis for shoulder joint includes at least two layers. In another embodiment, the prosthesis for the shoulder joint is provided with a visualization structure, and the visualization structure Made of metal developing material.

Optionally, the cross-section of the prosthesis for the shoulder joint in the expanded configuration is semicircular or crescent-shaped.

Optionally, when the prosthesis for the shoulder joint is in an expanded configuration, the first surface and the second surface are both a curved surface, and the radius of curvature of the curved surface is not less than 1.0 cm.

Optionally, the radius of curvature of the first surface is not less than 1.5 cm, and the radius of curvature of the second surface is not less than 3.0 cm.

Optionally, the length of the prosthesis for the shoulder joint in the expanded configuration ranges from 2.0 cm to 8.0 cm, the width ranges from 2.0 cm to 8.0 cm, and the height ranges from 0.4 cm to 2.5 cm.

Optionally, each layer of the prosthesis for the shoulder joint is one or a combination of a membrane structure and a braided structure.

Optionally, the innermost layer of the prosthesis for the shoulder joint is a membrane structure.

Optionally, the material strength of the outermost layer of the prosthesis for the shoulder joint is higher than the material strength of the innermost layer of the prosthesis for the shoulder joint.

Optionally, any two adjacent layers of the prosthesis for the shoulder joint are connected by hot melt connection or by an adhesive, or the prosthesis for the shoulder joint is processed by multi-layer coextrusion blow molding form.

Optionally, the visualization structure is provided in the prosthesis for the shoulder joint, or the visualization structure is provided on the outer surface of the prosthesis for the shoulder joint.

Optionally, the developing structure is a developing coating, and the developing coating is formed on the outer surface of the prosthesis for shoulder joints by vapor deposition or spraying of the metal developing material.

Optionally, the visualization structure is formed by thermally embedding the metal visualization material on the prosthesis for the shoulder joint.

Optionally, there are multiple visualization structures, which are arranged along the edge of the prosthesis for the shoulder joint. Optionally, the shape of the developing structure is a dot shape or an arc sheet shape.

Optionally, there are multiple visualization structures, which are distributed on the prosthesis for the shoulder joint at equal intervals. Optionally, the shape of the visualization structure is a long strip, and the length direction of the visualization structure is along the length direction of the prosthesis for the shoulder joint.

To achieve the above objective, the present invention also provides a prosthetic device, including a delivery system and any of the above The prosthesis of one item; wherein the delivery system is used to deliver the prosthesis for the shoulder joint to a predetermined position.

Optionally, the delivery system includes a delivery catheter and a drive rod; a seal is provided inside the prosthesis for the shoulder joint, and a connection part is provided at the proximal end of the prosthesis for the shoulder joint, so The connecting portion has a hollow channel communicating with the inside of the prosthesis for the shoulder joint; wherein:

The distal end of the delivery catheter is used to detachably connect with the connecting part to push the prosthesis for the shoulder joint; the driving rod can be movably inserted into the delivery catheter and passes through the connecting part Connected with the sealing element, the driving rod is used to drive the sealing element at least partially into the hollow passage, so that the sealing element blocks the hollow passage.

Optionally, the area where the drive rod is connected to the seal is a weak area, and the ultimate strength of the weak area is less than the ultimate strength of the seal and the drive rod, so that the drive rod is at Under the action of external force, it breaks at the weakened area and separates from the sealing element.

Compared with the prior art, the prosthesis and prosthesis device for shoulder joint provided by the present invention have the following beneficial effects;

First, after the prosthesis of the present invention is placed in the shoulder joint cavity, it can directly isolate the torn rotator cuff through expansion, prevent the rotator cuff wound from colliding with the bony structure of the acromion, thereby alleviating pain, and at the same time, reconstructing the acromion The distance between the heads of the humerus increases the moment arm raised by the shoulder joint and improves the mobility of the shoulder joint. The prosthesis of the present invention is particularly suitable for treating rotator cuff tears and other shoulder tendon injuries, and can be used to assist various This kind of shoulder surgery can help improve the mechanical conditions of the shoulder joint after surgery. In addition, after the prosthesis of the present invention is expanded, the first surface of the prosthesis is recessed inward to cover the end of the humeral head, and/or the second surface protrudes outward to fit the end of the acromion, which can effectively fix the prosthesis , To avoid displacement or even fall off of the prosthesis after surgery. At the same time, the prosthesis of the present invention does not require external components (such as anchors and other fixing devices) for fixation, and positioning and fixation can be achieved only through the cooperation of the self-forming surface with the corresponding bone structure. Not only the structure is simple, but also the trauma is small. Conducive to improving the effect of surgical treatment.

Second, the prosthesis of the present invention includes at least two layers, which enhances the puncture resistance of the prosthesis, and can effectively prevent the prosthesis from being punctured by the bone in the shoulder joint cavity after being implanted in the human body, and during arm movement, It can also reduce the wear of the humeral head to the prosthesis and ensure the reliability of the prosthesis after surgery.

Third, the prosthesis of the present invention is also provided with a visualization structure, which is beneficial to the doctor in a non-invasive manner after the operation The state of the prosthesis in the shoulder joint is checked by X-rays, avoiding the operation of surgery after the operation, thereby avoiding secondary injury to the patient and improving the effect of surgical treatment. Description of the drawings

Fig. 1 is a schematic diagram of placing a prosthesis between the acromion and the humerus according to an embodiment of the present invention; Fig. 2a is a perspective view of the prosthesis according to an embodiment of the present invention;

Figure 2b is a front view of the prosthesis shown in Figure 2a;

Fig. 2c is a schematic diagram of the prosthesis of an embodiment of the present invention before forming a concave curved structure; Fig. 2d is a cross-sectional view of the inner cavity of the prosthesis of a preferred embodiment of the present invention;

Fig. 3a is a schematic diagram of an arc-shaped first developing structure provided on a prosthesis according to an embodiment of the present invention; Fig. 3b is a schematic diagram of an elongated second developing structure provided on a prosthesis according to an embodiment of the present invention; A schematic diagram of a wave-shaped groove provided on the prosthesis of an embodiment of the present invention;

Fig. 5a and Fig. 5b are respectively schematic diagrams of sealing the prosthesis in the prosthesis device of an embodiment of the present invention;

Fig. 5c is a schematic diagram of the separation of the prosthesis and the delivery system in the prosthesis device according to an embodiment of the present invention. Wherein, the reference signs are described as follows:

10- Rotator cuff balloon; 10'-Balloon structure; 11-First surface; 12-Second surface; 13-Inner layer; 14-Outer layer; 15-First imaging structure; 16-Second imaging structure; 17-groove; 18-connecting part; 19-seal; 20-acromion; 30-humeral head; 40-delivery system; 41-delivery catheter; 42-drive rod. detailed description

In order to make the purpose, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings all adopt a very simplified form and all use imprecise proportions, which are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

In the following description, a large number of specific details are given to provide a more thorough understanding of the present invention. However, it is obvious to those skilled in the art that the present invention can be implemented without one or more of these details. In other examples, in order to avoid confusion with the present invention, some technical features known in the art are not described. As used in this specification and the appended claims, the terms "first" and "second" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the indicated technical features. Quantity. Therefore, the features defined with “first” and “second” may explicitly or implicitly include one or more of these features. In the description of the present invention, unless otherwise specified, "plurality" means two or more. In addition, in the following description, for ease of description, "proximal" and "distal" are also used; "proximal" refers to the end closer to the operator of the delivery system, and "distal" refers to the distance from the operator of the delivery system At the far end.

The core idea of the present invention is to provide a prosthesis for the shoulder joint, which is used to be delivered to the shoulder joint cavity of the human shoulder joint (placed between the acromion and the humeral head) to maintain and/or increase the acromion and The distance between the head of the humerus can directly isolate the torn rotator cuff and prevent the impact of the rotator cuff wound with the bony structure of the acromion, thereby alleviating the pain. At the same time, the distance between the acromion and the head of the humerus is rebuilt to increase the shoulder The raised arm of the joint improves the mobility of the shoulder joint. The prosthesis of this embodiment is suitable for treating rotator cuff tears and other shoulder tendon injuries, and can be used to assist various shoulder joint surgeries, which helps to improve the mechanical conditions after shoulder joint surgery and improve the treatment effect.

In the present invention, the prosthesis for the shoulder joint has an expandable and contractible structure.

In an embodiment, the prosthesis for the shoulder joint has a first surface and a second surface that are opposed to each other, the first surface is configured to face the humeral head, and the second surface is configured to face the acromion . And when the prosthesis for the shoulder joint is expanded in the shoulder joint cavity, the first surface is recessed inward (that is, the first surface appears close to the second surface) or is flat, preferably The first surface is an inner concave surface, and the second surface is convex outward (that is, the second surface is in a state away from the first surface), preferably an outer convex surface. Here, the first surface is recessed toward the inside of the prosthesis to form an inner concave surface to wrap the end of the humeral head and prevent the prosthesis from shifting, and the second surface protrudes toward the outside of the prosthesis to form a convex surface, so as to be able to interact with The acromion fits to further prevent the prosthesis from shifting and the fixation effect is better. The "inwardly concave" means that the first surface as a whole is dented in the direction close to the center point of the prosthesis, regardless of whether the surface is flat or not; the "outwardly convex" means that the second surface as a whole is away from the false The direction of the center point of the body is convex, regardless of whether the surface is flat; the “inner concave surface” refers to a cut surface that passes through any point on the first surface, and the cut surface is located on the inner side of the first surface; the “convex surface” refers to Make a cut plane through any point on the second surface, and the cut plane is located outside the second surface. In another embodiment, considering that the prosthesis needs to withstand a relatively large force in the shoulder joint cavity, and the movement of the shoulder joint will also cause wear and tear, it is easy to puncture the prosthesis. For this reason, the prosthesis for the shoulder joint It is preferably at least a two-layer structure, which not only has good strength of the prosthesis, but also has good puncture resistance.

In another embodiment, the prosthesis for the shoulder joint is provided with a developing structure, and the developing structure is made of a metal developing material. Furthermore, the visualization structure can facilitate the observation of information such as the shape and position of the prosthesis under X-rays after the operation, so as to avoid secondary operations after the operation and reduce the damage to the patient.

Next, the prosthesis for the shoulder joint of the present invention will be further explained in conjunction with the drawings and specific embodiments.

Fig. 1 is a schematic diagram of placing the prosthesis between the acromion and the humerus according to an embodiment of the present invention. As shown in FIG. 1, the prosthesis is specifically the rotator cuff balloon 10. In actual surgery, the rotator cuff balloon 10 is implanted between the acromion 20 and the humeral head 30 to maintain and/or increase The distance between the acromion 20 and the humeral head 30. In addition, the rotator cuff balloon 10 has an inner cavity, and the inner cavity is used to pass the gas or liquid for filling the rotator cuff balloon 10, and the rotator cuff balloon can be filled with water, physiological saline, simulated body fluid, or contrast agent. Cyst 10. The material of the rotator cuff balloon 10 can be a biodegradable medical polymer material or a non-biodegradable medical polymer material. If the rotator cuff balloon 10 is not degradable, it will remain in the body as a long-term implant, and it will need to be removed by a second operation. Conversely, if the rotator cuff balloon 10 is degradable, after a long-term implantation of the rotator cuff balloon 10 into the human body, it will eventually undergo biodegradation to achieve no residues, avoiding secondary surgical removal, which causes little harm to the patient. In the embodiment of the present invention, the non-biodegradable medical polymer material can be selected from one or more combinations of polyester, polyamide, polyvinyl chloride, nylon elastomer, and polyurethane elastic rubber; biodegradable medical The polymer material can be selected from polylactic acid, polycaprolactone, polylactide-caprolactone copolymer, polypeptide, polyamino acid, poly-3-hydroxyalkanoate, chitin and PBS (polybutylene succinate) ) In one or more combinations.

Fig. 2a is a perspective view of a prosthesis according to an embodiment of the present invention, and Fig. 2b is a front view of the prosthesis shown in Fig. 2a. As shown in FIGS. 2a and 2b, and in conjunction with FIG. 1, the rotator cuff balloon 10 has a first surface 11 and a second surface 12 opposite to each other, and the first surface 11 is used to face the humeral head 30, The second surface 12 is used to face the acromion 20. In the embodiment of the present invention, at least one of the first surface 11 and the second surface 12 is used to realize the fixation of the rotator cuff balloon 10 in the shoulder joint cavity and prevent the rotator cuff balloon 10 from shifting. Specifically, the first surface 11 can be recessed inward to cover the humeral head 30 The end; or, the second surface 12 may protrude outward to fit the end of the acromion 20; or, the first surface 11 is recessed inwardly when covering the end of the humeral head 30, so The second surface 12 also protrudes outwardly to fit the end of the acromion 20; these methods can fix the rotator cuff balloon 10 to prevent the rotator cuff balloon 10 from sliding in the shoulder joint cavity, and the rotator cuff balloon 10 There is no need for external parts (such as anchors and other fixing devices) for fixation. Self-fixation can be realized only by matching the self-forming surface with the corresponding bone structure. Not only the structure is simple, but the trauma is also small, which is beneficial to improve the surgical treatment effect.

In an embodiment, the expanded rotator cuff balloon 10 may be a spherical crown (not shown), that is, the cross-section of the rotator cuff balloon 10 (that is, from the first surface to the second surface) The cut surface) is semicircular. At this time, the first surface 11 is a flat surface, and the second surface 12 is a circular arc surface. In other embodiments, the expanded rotator cuff balloon 10 may also be shield-shaped (see Figures 2a and 2b), that is, the cross-section of the rotator cuff balloon 10 (here, along the left and right directions) The section from the first surface to the second surface) is crescent-shaped. At this time, the first surface 11 and the second surface 12 are both circular arc surfaces. However, the first surface 11 and the second surface 12 are not limited to circular arc surfaces, and may also be non-circular arc surfaces, including arc-like surfaces. It should be understood that the shape and size of the first surface 11 are mainly set according to the shape and size of the humeral head of the patient, so that the first surface 11 can match the end of the humeral head, and of course the shape and size of the second surface 12 The size is also mainly set according to the shape and size of the patient's acromion, so that the second surface 12 can fully fit the end of the acromion, and the fixing effect is better.

Further, when the first surface 11 is an inwardly concave surface, the radius of curvature of the first surface 11 may be not less than 1.0 cm, and further, when the first surface 11 is a circular arc surface When, the radius of curvature can be selected to be not less than 1.5cm. In addition, when the second surface 12 is a convex arc surface, the radius of curvature of the second surface 12 may also be selected to be not less than 1.0 cm. For example, when the second surface 12 is a circular arc surface, the radius of curvature may be Choose not less than 3.0cm. Within these radius of curvature, the rotator cuff balloon 10 of this embodiment can basically meet the needs of different bone sizes and age levels. And in an exemplary embodiment, after the rotator cuff balloon 10 is expanded, its length can be selected from 2.0 cm to 8.0 cm, the width can be selected from 2.0 cm to 8.0 cm, and the height can be selected from 0.4. cm~2.5cm, within these size ranges, the overall size of the rotator cuff balloon 10 after expansion can meet the rotator cuff repair needs of different people.

Further, the rotator cuff balloon 10 after expansion is preferably matched with the shoulder joint cavity, so that the balloon can fit and fill the shoulder joint cavity as a whole, thereby more effectively preventing the rotator cuff balloon 10 from developing after surgery. Therefore, after the balloon fills and expands in the shoulder joint cavity, the rotator cuff balloon 10 can fully fit the acromion 20, the coracoid process, the coraco scapularis, the humeral head 30, the supraspinatus tendon, etc. around the shoulder joint cavity. The tissue structure is positioned and fixed by the first surface 11 and/or the second surface 12, so as to effectively prevent the balloon from slipping off with the movement of the shoulder joint during postoperative rehabilitation exercises. Therefore, after the rotator cuff balloon 10 of the present invention is expanded, it conforms to the physiological configuration of the shoulder joint cavity formed by the acromion, humeral head and cuff-like tendon complex of the human body, and has a good fixation effect.

The preparation method of the rotator cuff balloon 10 is not specifically limited, and it may be blow molding or other molding methods. Here, blow molding is preferred, which has low processing cost and good processing effect. Blow molding process includes extrusion blow molding and injection blow molding. In a non-limiting preparation method, the preparation process can be:

First, the balloon material is heated and extruded by a screw to obtain an initial structure of a tubular balloon. Then, the initial structure of the balloon is put into a blow mold for heating and pressure setting, and finally a rotator cuff balloon 10 of a desired shape is obtained. Among them, the diameter of the screw is preferably 50mm to reduce the loss of the balloon material during processing and reduce the cost. At the same time, the heating temperature of the blow mold is preferably the same as or close to the melting point of the balloon material, for example, the heating temperature of the blow mold can be set to 140 ^° C~180 ^° C, this can improve the connection strength of the balloon edge and avoid leakage. In the present invention, in the balloon molding process, the rotator cuff balloon 10 of the desired shape can be obtained by one-time shaping by a blow mold, or as shown in FIG. 2c, the initial balloon structure 10' can be adjusted by a newly designed blow mold. Perform secondary shaping to obtain the rotator cuff balloon 10 of the desired shape.

Further, the rotator cuff balloon 10 preferably has a structure of more than two layers, but includes but is not limited to two layers. When the rotator cuff balloon 10 is multi-layered, the strength of the balloon can be significantly enhanced, so that the balloon can withstand greater force in the shoulder joint cavity, and at the same time can enhance the puncture resistance of the balloon and prevent the balloon from being After being implanted in the human body, it is pierced by a bone spur in the shoulder joint cavity, and can also enhance the resistance of the humeral head abrasion balloon during arm movement, so the multilayer balloon has good puncture resistance and abrasion resistance. For example, as shown in Figure 2d, the rotator cuff balloon 10 has a two-layer structure, namely an inner layer 13 and an outer layer 14. The outer layer 14 and the inner layer 13 can be connected by thermal fusion or an adhesive. Connect, or integrally molded by multi-layer co-extrusion blow molding. If the rotator cuff balloon 10 is made of degradable materials, the outer layer 14 and the inner layer 13 are preferably connected by hot melting or multi-layer co-extrusion blow molding. For example, the outer layer 14 and the inner layer 13 have a good bonding effect. Moreover, the materials of the inner layer 13 and the outer layer 14 may be the same or different, and the materials of each layer may be degradable or different. It is degradable, but the wall thickness of the outer layer 14 and the inner layer 13 can be set according to actual clinical requirements, which is not required by the present invention. In addition, in the multi-layer co-extrusion blow molding process, it is preferable that the melting point of each layer of the balloon is the same or similar, which helps to enhance the connection strength between the layers. The present invention does not specifically limit the thickness of each layer of the balloon, and optionally, the percentage of each layer to the total thickness of the balloon is not less than 5%. In an exemplary embodiment, the rotator cuff balloon 10 has a two-layer structure, wherein the material of the inner layer 13 is selected from polylactide-polycaprolactone copolymer, optionally, polylactide and polycaprolactone The content ratio of ester is 7:3, and the material of the outer layer 14 is also polylactide-polycaprolactone copolymer, and the content ratio of polylactide to polycaprolactone is 5:5, and the inner layer 13 The thickness of the outer layer 14 may be the same.

In the embodiment of the present invention, each layer of the rotator cuff balloon 10 can be made of a film, or can be woven from a braided wire. The film has a better sealing effect and can prevent leakage of the filling liquid inside the balloon, and The multilayer film can also enhance the puncture resistance of the balloon. Of course, compared with a single-layer balloon, the braided structure can also effectively increase the strength of the balloon and enhance the puncture resistance of the balloon. Preferably, the inner layer of the rotator cuff balloon is a membrane structure, and the structure of other layers is not particularly limited, and may be a membrane structure, a woven structure, or a composite of a woven structure and a membrane structure. More preferably, the material strength of the outer layer of the rotator cuff balloon 10 is higher than the material strength of the inner layer, and the material strength is not limited to shear modulus, tensile strength, and the like. More preferably, each layer of the rotator cuff balloon is selected from biodegradable materials, and the degradation time of all the layers is configured to be different, for example, from the inside to the outside, each layer is degraded in sequence, which can better control the ball The degradation rate of the capsule, to achieve a better therapeutic effect.

Further, the rotator cuff balloon 10 is also preferably visualized. On the one hand, it is helpful to check the suitability of the rotator cuff balloon 10 in the shoulder joint cavity by X-ray during the operation, the filling and expansion state, etc. On the other hand, in the rehabilitation process of postoperative patients, doctors can use X-rays to non-invasively check whether the rotator cuff balloon 10 is damaged or leaked in the shoulder joint cavity, whether the balloon position is correct, and the balloon deformation is avoided. The state of the balloon is checked by surgical invasive surgery, so as to avoid secondary injury to the patient after the operation. In the embodiment of the present invention, a developing structure is provided on the outer surface or cavity wall of the rotator cuff balloon 10, and the developing structure is made of a developing material such as metal, metal oxide or metal salt, and the developing material can be selected from BaS0. _4. Bi ₂ 0 ₃ , (Bi0) ₂ C0 ₃ , BiOCl, W, WC, Mg, Fe, Nd, Zn, Zr and other developing materials of one or more combinations. Particularly, when the biodegradable medical polymer material is selected for the balloon, the developing structure selects biomedical biodegradable metal materials such as magnesium-based, ci-based, and iron-based materials. One or more combinations of. Optionally, the developing structure is in the form of dots, blocks or flakes, and the form of the developing structure is not particularly limited in the present invention. Preferably, there are multiple development structures.

In some embodiments, a plurality of the visualization structures are preferably distributed along the edge of the rotator cuff balloon 10. The advantage is that the operator analyzes the outline and filling state of the balloon by visual observation of the plurality of visualization structures under X-rays. In some embodiments, the multiple visualization structures are preferably distributed on the outer surface of the rotator cuff balloon at equal intervals, which is convenient for the operator to analyze the bending deformation state, filling state, etc. of the balloon by visual observation of the multiple visualization structures under X-ray.

As shown in FIG. 3a, a plurality of first visualization structures 15 may be provided on the outer surface of the rotator cuff balloon 10, and the plurality of first visualization structures 15 may be distributed along the edge of the rotator cuff balloon 10, for example, At the four corners of the balloon, and the first developing structure 15 may preferably be dot-shaped or arc-shaped sheet-shaped. As shown in FIG. 3b, a plurality of second developing structures 16 may also be provided on the outer surface of the rotator cuff balloon 10. The plurality of second developing structures 16 are distributed at equal intervals, and the second developing structures 16 are preferably elongated. And the length direction of the second developing structure 16 is the length direction of the rotator cuff balloon 10 (that is, the axial direction). At this time, it is convenient for the operator to observe and analyze the bending deformation of the ball under X-ray by the development of the second developing structure 16 State and filling state. And in actual application, multiple first developing structures 15 and multiple second developing structures 16 can be provided on the balloon at the same time, and arranged in the aforementioned manner, so as to obtain corresponding developing effects. In the embodiment of the present invention, the first developing structure 15 may be thermally embedded in the wall of the rotator cuff balloon 10 during the balloon molding process, and the second developing structure 16 is outside the balloon by vapor deposition or spraying. A developed coating is formed on the surface. Among them, vapor deposition or spraying can realize a low-thickness development structure on the balloon, avoid the rigidity of the development structure from affecting the expansion and folding of the balloon, and can also reduce the damage to the balloon and avoid affecting the strength of the balloon. In addition, hot mounting is achieved by embedding a prefabricated developing structure into the heated balloon wall on a heated balloon, and then cooling and fixing it. Of course, the developing structure can also be embedded in the wall of a multilayer balloon. The advantage of the hot mounting method is that the process is simple, but it will inevitably cause damage to the balloon wall and reduce the strength of the balloon, especially for degradable balloons. The heating during the hot mounting process will accelerate the degradation of the balloon and reduce the balloon. The molecular weight and strength of the capsule material.

Further, the rotator cuff balloon 10 preferably also carries a drug, for example, a drug is provided on at least part of the outer surface of the balloon. The drug here can be used to promote the recovery of injured tendons or relieve pain and analgesia, so as to promote tearing. The tendon growth is restored or the patient's pain is reduced. For example, the drug can be diclofenac Ethylamine, Fentanyl, Etorphine a 2 Receptor Agonist Medetomidine, Flupacidol, Etonamidine Ester, Vecuronium Bromide Procaine Hydrochloride, Tetracaine Hydrochloride, Lidoca Because of hydrochloride and other growth factors that promote tendon growth and recovery, or one or more combinations of drugs that have analgesic and analgesic effects. In some embodiments, the drug is directly coated on at least part of the outer surface of the balloon; in some embodiments, as shown in FIG. 4, a groove 17 is provided on the outer surface of the balloon, and the drug contains Placed in the groove 17. Carrying medicines through the grooves 17 can increase the load of medicines and better realize the medicine treatment. However, the shape and size of the grooves 17 can be adjusted according to the medicine load of clinical requirements. In addition, the shape of the grooves 17 is also different. Limited to the shape shown in FIG. 4, in actual application, the shape, width, depth, etc. of the groove 17 can be adjusted according to actual requirements such as the dosage of the drug and the diffusion rate of the drug after contacting the blood vessel. In the embodiment of the present invention, the grooves 17 may be linear, curved, or a combination of curves and straight lines. The curved shape may be designed to be wave-shaped, and the grooves 17 may also be multiple. The multiple grooves 17 may be arranged at intervals, or may be arranged crosswise. The specific arrangement is not limited in the present invention, and the grooves 17 may be processed by laser etching or mold thermoforming.

Continuing to refer to Figures 2a and 2b, the proximal end of the rotator cuff balloon 10 has a connecting portion 18, and the connecting portion 18 has a hollow channel communicating with the inside of the balloon, and in actual use, the connecting portion 18 is used for It is detachably connected with the delivery system, and the balloon is pushed through the delivery system to realize the implantation of the balloon. Specifically, during the operation, the rotator cuff balloon 10 in the folded state is first sent into the shoulder joint cavity through the percutaneous passage of the shoulder arthroscopy or a separate percutaneous puncture channel through the delivery system, and the folded state includes the compressed state; After determining the position of the rotator cuff balloon 10, the delivery system sends the filling liquid provided by an external syringe, an inflator or other filling device into the rotator cuff balloon 10, so that the rotator cuff balloon 10 is filled and expanded (in this process, The visualization performance of the balloon can be used to observe the filling state and bending state of the balloon, and after the balloon is filled, the rotator cuff balloon 10 can be further closed; finally, the delivery system and the rotator cuff balloon 10 are separated and withdrawn The human body is fine.

Next, referring to Figures 5a to 5c, an embodiment of the present invention also provides a delivery system 40. The delivery system 40 includes a delivery catheter 41. The distal end of the delivery catheter 41 is used to detachably connect with the connecting portion 18, and The inner cavity of the delivery catheter 41 communicates with the inner cavity of the balloon. After the delivery catheter 41 is connected to the connecting portion 18, the filling liquid can be directly delivered into the rotator cuff balloon 10 through the delivery catheter 41 to achieve the inflation of the balloon, and the balloon can also be pushed through the delivery catheter 41 to achieve the balloon in the body. freed. Delivery catheter The connection between 41 and the connecting portion 18 may be a detachable connection such as a spring buckle, a snap buckle, and a thread.

Preferably, the rotator cuff balloon 10 further includes a sealing member 19 which is arranged in the inner cavity of the rotator cuff balloon 10, and when the rotator cuff balloon 10 is filled and expanded in the body, the sealing member 19 It is used to block the connecting portion 18 to prevent the filling liquid from flowing out. Optionally, the sealing member 19 is a one-way valve made of a polymer material. The one-way valve can be arranged in the hollow channel of the connecting portion 18, or can be arranged at the inlet or outlet of the hollow channel, and the one-way valve The material can be biodegradable or non-biodegradable. Optionally, the sealing member 19 may also be at least partially inserted into the connecting portion 18 and sealedly connected with the connecting portion 18 driven by an external force.

Preferably, the delivery system 40 further includes a drive rod 42 that is movably inserted into the delivery catheter 41 and passes through the connecting portion 18 to be detachably connected to the seal 19. As shown in Fig. 5a, when the rotator cuff balloon 10 is filled and expanded, the driving rod 42 is used to drive the sealing member 19 at least partially into the hollow channel, so that the sealing member 19 blocks the hollow channel . Here, the sealing element 19 can be pre-sealed inside the rotator cuff balloon 10, and the operator can pull the driving rod 42 at the proximal end to make the sealing element 19 enter the connecting portion 18 to achieve sealing, where the connecting portion 18 and the sealing element 19 The sealed connection can be achieved through interference fit, which is convenient to operate and has a good sealing effect.

Preferably, the area where the drive rod 42 is connected to the seal 19 is configured as a weak area, and the ultimate strength of the weak area is less than the ultimate strength of the seal 19 and the drive rod 42, so that the drive rod 42 and the sealing member 19 are broken at the weak area under the action of external force, so that the sealing member 19 is separated from the driving rod 42, as shown in FIG. 5b. Finally, as shown in Fig. 5c, after the rotator cuff balloon 10 is inflated and sealed in the body, the driving rod 42 and the delivery catheter 41 can be withdrawn from the human body in the direction indicated by the arrow.

Finally, the embodiment of the present invention also provides a prosthetic device for shoulder joint surgery, which includes a delivery system 40 and a rotator cuff balloon 10, the delivery system 40 is used to deliver the rotator cuff balloon 10 to the shoulder joint The cavity allows the rotator cuff balloon 10 to be housed between the acromion 20 and the humeral head 30 to maintain and/or increase the distance between the acromion 20 and the humeral head 30.

The preferred embodiments of the present invention are as described above, but are not limited to the scope disclosed by the above-mentioned embodiments, and any changes made within the scope of the disclosure of this application fall within the protection scope of the present invention.

In summary, after the rotator cuff balloon of the present invention is placed in the shoulder joint cavity, it can directly isolate the tear through expansion The rotator cuff prevents the impact of the rotator cuff wound with the bony structure of the acromion, thereby alleviating the pain. At the same time, the distance between the acromion and the head of the humerus is reconstructed, increasing the lifting arm of the shoulder joint and improving the movement of the shoulder In addition, the prosthesis of the present invention is particularly suitable for treating rotator cuff tears and other shoulder tendon injuries, and can be used to assist various shoulder joint surgeries and help improve mechanical conditions after shoulder joint surgery. Moreover, after the rotator cuff balloon of the present invention is expanded, the first surface of the rotator cuff balloon is recessed inward to cover the end of the humeral head, and/or the second surface protrudes outward to fit the end of the acromion, which can effectively fix The rotator cuff balloon prevents the rotator cuff balloon from shifting or even falling off after surgery. At the same time, the rotator cuff balloon of the present invention does not require external components (such as anchors and other fixing devices) for fixation, and positioning and fixation can be achieved only by matching the self-forming surface with the corresponding bone structure. The structure is not only simple, but also less traumatic. , It is helpful to improve the effect of surgical treatment.

The rotator cuff balloon of the present invention has at least a two-layer structure, which enhances the puncture resistance of the rotator cuff balloon, and can effectively prevent the rotator cuff balloon from being punctured by bone in the shoulder joint cavity after implantation in the human body. During exercise, it can also reduce the wear of the humeral head to the rotator cuff balloon, and ensure the reliability of the rotator cuff balloon after surgery.

The rotator cuff balloon of the present invention is also provided with a visualization structure, which is beneficial for the doctor to check the state of the rotator cuff balloon in the shoulder joint through X-rays without trauma after the operation, and avoids the operation of the operation after the operation. Cause secondary injury to the patient and improve the effect of surgical treatment.

The foregoing description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person of ordinary skill in the field of the present invention based on the foregoing disclosure shall fall within the protection scope of the claims.

Claims

Rights request

1. A prosthesis for a shoulder joint, having an expanded configuration and a contraction configuration, characterized in that the prosthesis for the shoulder joint has a first surface and a second surface that are opposed to each other, and when the When the prosthesis for the shoulder joint is in the expanded configuration, the first surface is curved or flat in a direction close to the second surface, and the second surface protrudes in a direction away from the first surface.

2. The prosthesis for shoulder joints according to claim 1, wherein the cross-section of the prosthesis for shoulder joints in the expanded configuration is semicircular or crescent-shaped.

3. The prosthesis for the shoulder joint according to claim 1 or 2, wherein when the prosthesis for the shoulder joint is in an expanded configuration, the first surface and the second surface All are a curved surface, and the radius of curvature of the curved surface is not less than 1.0 cm.

4. The prosthesis for shoulder joints according to claim 3, wherein the radius of curvature of the first surface is not less than 1.5 cm, and the radius of curvature of the second surface is not less than 3.0 cm.

5. The prosthesis for the shoulder joint according to claim 1 or 2, wherein the prosthesis for the shoulder joint in the expanded configuration has a length ranging from 2.0 cm to 8.0 cm, and a width ranging from 2.0 cm～8.0cm, the height range is 0.4 cm～2.5cm.

6. The prosthesis for shoulder joints according to claim 1 or 2, wherein the prosthesis for shoulder joints comprises at least two layers.

7. The prosthesis for the shoulder joint according to claim 1 or 2, wherein the prosthesis for the shoulder joint is provided with a developing structure, and the developing structure is made of a metal developing material.

8. A prosthesis for a shoulder joint, having an expanded configuration and a contraction configuration, characterized in that the prosthesis for the shoulder joint includes at least two layers.

9. The prosthesis for the shoulder joint according to claim 8, wherein the layers of the prosthesis for the shoulder joint are one or a combination of a membrane structure and a braided structure.

10. The prosthesis for the shoulder joint according to claim 9, wherein the innermost layer of the prosthesis for the shoulder joint is a membrane structure.

11. The prosthesis for the shoulder joint according to claim 8, wherein the material strength of the outermost layer of the prosthesis for the shoulder joint is higher than that of the prosthesis for the shoulder joint. Inner material Material strength.

12. The prosthesis for the shoulder joint according to any one of claims 8-11, wherein any two adjacent layers of the prosthesis for the shoulder joint are connected by hot melt or by bonding Or, the prosthesis for shoulder joint is formed by multi-layer co-extrusion blow molding.

13. The prosthesis for the shoulder joint according to any one of claims 8-11, wherein the prosthesis for the shoulder joint is provided with a developing structure, and the developing structure is made of a metal developing material. Made o

14. A prosthesis for a shoulder joint, having an expanded configuration and a contraction configuration, characterized in that the prosthesis for the shoulder joint is provided with a developing structure, and the developing structure is made of a metal developing material o

15. The prosthesis for the shoulder joint according to claim 14, wherein the visualization structure is provided in the prosthesis for the shoulder joint, or the visualization structure is provided in the prosthesis for the shoulder joint. The shoulder joint is on the outer surface of the prosthesis.

16. The prosthesis for shoulder joints according to claim 15, wherein the developing structure is a developing coating, and the metal developing material is vapor deposited or sprayed on the shoulder joints. The developed coating is formed on the outer surface of the prosthesis.

17. The prosthesis for the shoulder joint of claim 15, wherein the visualization structure is formed by thermally embedding the metal visualization material in the prosthesis for the shoulder joint.

18. The prosthesis for shoulder joints according to claim 14, wherein there are a plurality of the visualization structures, which are arranged along the edge of the prosthesis for shoulder joints.

19. The prosthesis for shoulder joints according to claim 18, wherein the shape of the visualization structure is a dot shape or an arc sheet shape.

20. The prosthesis for shoulder joint according to claim 14, characterized in that there are a plurality of said imaging structures, which are distributed on the prosthesis for shoulder joint at equal intervals.

21. The prosthesis for shoulder joints according to claim 20, wherein the shape of the visualization structure is elongated, and the length direction of the visualization structure is along the prosthesis for shoulder joints. The length of the body.

22. The prosthesis for shoulder joints according to any one of claims 14-21, characterized in that: The prosthesis for shoulder joint includes at least two layers;

The prosthesis for the shoulder joint has a first surface and a second surface that are opposed to each other, and when the prosthesis for the shoulder joint is in an expanded configuration, the first surface approaches the second surface The direction is curved or flat, and the second surface protrudes away from the first surface.

23. A prosthetic device, characterized by comprising a delivery system; and the prosthesis for the shoulder joint as claimed in any one of claims 1-7, or as claimed in any one of claims 8-13 The prosthesis for the shoulder joint, or the prosthesis for the shoulder joint according to any one of claims 14-22; wherein, the delivery system is used to transfer the prosthesis for the shoulder joint Deliver to a predetermined location.

24. The prosthesis device according to claim 23, wherein the delivery system includes a delivery catheter and a drive rod; a seal is provided inside the prosthesis for the shoulder joint, and the prosthesis for the shoulder The proximal end of the prosthesis of the joint is provided with a connecting part, and the connecting part has a hollow channel communicating with the inside of the prosthesis for the shoulder joint; wherein:

25. The prosthetic device according to claim 24, wherein the area where the drive rod is connected to the seal is a weak area, and the ultimate strength of the weak area is less than that of the seal and the drive The respective ultimate strength of the rods is such that the driving rod is broken at the weakened area under the action of external force, and is separated from the sealing member.