WO2023029735A1 - 用于肩关节的修复装置以及假体系统 - Google Patents

用于肩关节的修复装置以及假体系统 Download PDF

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Publication number
WO2023029735A1
WO2023029735A1 PCT/CN2022/103747 CN2022103747W WO2023029735A1 WO 2023029735 A1 WO2023029735 A1 WO 2023029735A1 CN 2022103747 W CN2022103747 W CN 2022103747W WO 2023029735 A1 WO2023029735 A1 WO 2023029735A1
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WO
WIPO (PCT)
Prior art keywords
repair
shoulder joint
capsule
joint according
repair device
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PCT/CN2022/103747
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English (en)
French (fr)
Inventor
陈晓
刘琛
葛亮
Original Assignee
上海竞捷医疗科技有限公司
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Publication of WO2023029735A1 publication Critical patent/WO2023029735A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments

Definitions

  • the present application relates to the technical field of medical devices, in particular to a repair device and a prosthesis system for shoulder joints.
  • the rotator cuff is the muscle-tendon structure that connects the scapula to the head of 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 posterior rotator cuff (infraspinatus and teres minor).
  • the main function is to stabilize the position of the humeral head on the glenoid, avoiding pain caused by the humeral head moving up and hitting 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.
  • the 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.
  • partial rotator cuff repair mainly include partial rotator cuff repair, rotator cuff reconstruction, local muscle transfer, upper joint capsule reconstruction, and reverse shoulder joint replacement.
  • rotator cuff reconstruction mainly includes partial rotator cuff repair, rotator cuff reconstruction, local muscle transfer, upper joint capsule reconstruction, and reverse shoulder joint replacement.
  • the present application provides a repair device for shoulder joint, comprising:
  • a cushioning portion which may be in a deflated state or an expanded state, said cushioning portion comprising a cavity configured to be filled with a substance to bring said cushioning portion into said expanded state;
  • a prosthesis configured to cover at least one of the humeral head and the tendon
  • the bordering part is located on a side of the repair part away from at least one of the humeral head and the tendon, and the buffer part is movably connected to the repair part through the bordering part.
  • the buffer part includes a capsule, the cavity is formed inside the capsule, the bordering part is arranged on the surface of the capsule away from the acromion, and the area of the bordering part is smaller than that of the capsule away from the acromion.
  • the cushioning part includes a capsule body and a capsule casing, the cavity is formed inside the capsule body, the capsule casing contains an inner space, and the capsule body is movably arranged in the inner space, The bordering part is arranged on the surface of the outer shell of the capsule away from the acromion.
  • the repair part is a sheet structure, and the sheet structure is fixed to the humeral head by anchors or sutures.
  • the adjoining portion includes a braided area through which the surface of the repaired portion and the surface of the cushioning portion are fixed.
  • the braided area includes at least a part of the covering layer formed by weaving the surface of the buffer part by braiding wires, and the covering layer is formed by weaving the braiding wires extending from the buffer part to the repaired part.
  • the braided wire is made of polyethylene, titanium alloy or developer-modified yarn.
  • the junction part includes a hot-melt connection area, and the surface of the repaired part and the surface of the buffer part are heat-fused and fixed through the hot-melt connection area.
  • the bordering portion includes an adhesive layer, and the surface of the repaired portion and the surface of the buffer portion are bonded and fixed through the adhesive layer.
  • a strap, the bordering portion is formed by connecting the strap to the surface of the repaired portion near the acromion, and the buffer portion is fixed on the repaired portion through the strap.
  • the buffer is a non-degradable capsule or a degradable capsule.
  • the repair part is a non-degradable patch, a degradable patch, a biological patch or a composite patch.
  • the buffer part is a degradable capsule
  • the repair part is a non-degradable patch.
  • the side of the repair part close to the humeral head includes a curved surface, a concave or a protruding structure, which is adapted to the acromion or the humeral head.
  • the repaired portion is square, and the repaired portion has a length of about 20 mm to about 50 mm.
  • the application provides a prosthesis system, comprising:
  • a conveying device connected to the restoration device, for conveying the restoration device.
  • the prosthetic part can be directly used to connect the tendon and the humeral head. Fixation is formed in the tissue, and the buffer part is also fixed at the same time, thereby realizing the fixation of the entire repair device.
  • the operation is very simple, only the repair part needs to be fixed, and the buffer part does not need to be fixed during the operation. Relatively Because both the repair part and the buffer part need to be fixed during one operation, the discomfort caused by the operation to the patient can be greatly reduced.
  • the repair part can be used to assist the healing of the rotator cuff tissue and reshape the integrity of the rotator cuff, but also the buffer part can be used to quickly improve the shoulder joint pain and limited shoulder joint mobility caused by the rotator cuff injury. Patients can quickly get rid of their injuries and achieve fundamental and rapid treatment of severe rotator cuff injuries.
  • Fig. 1 is a schematic view of the use state of the repair device for the shoulder joint in some embodiments of the present application
  • FIG. 2 is a schematic cross-sectional view of a repair device for shoulder joint in some embodiments of the present application
  • FIG. 3 is a schematic plan view of a repair device for shoulder joints in some embodiments of the present application.
  • Fig. 4 is a schematic diagram of the cooperative structure of the capsule cover and the capsule in some embodiments of the present application.
  • Fig. 5 is a schematic structural view of a repair device for a shoulder joint with a protective layer in some embodiments of the present application.
  • FIG. 6 is a schematic cross-sectional view of the cladding layer connection of the repair device for the shoulder joint in some embodiments of the present application;
  • Fig. 7 is a schematic cross-sectional view of the hot-melt connection of the repair device for the shoulder joint in some embodiments of the present application;
  • Fig. 8 is a schematic cross-sectional view of an adhesive connection of a repair device for a shoulder joint in some embodiments of the present application
  • Fig. 9 is a schematic cross-sectional view of the strap connection of the repair device for the shoulder joint in some embodiments of the present application.
  • Fig. 10 is a schematic plan view of the strap connection of the repair device for the shoulder joint in some embodiments of the present application.
  • Figure 11 is a schematic diagram of the shape of the repaired part in some embodiments of the present application.
  • Fig. 12 is a schematic diagram of another shape of the repair part in some embodiments of the present application.
  • Fig. 13 is another schematic diagram of the shape of the repaired part in some embodiments of the present application.
  • capsule body coat 120, capsule body; 130, protective layer; 140, strap.
  • 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.
  • the features defined as “first” and “second” may explicitly or implicitly include at least one of these features.
  • “plurality” means at least two, such as two, three, etc., unless otherwise specifically defined.
  • 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.
  • “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 horizontally higher 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.
  • balloon therapy can be used.
  • the balloon is directly implanted into the shoulder joint, and the balloon is located between the acromion and humeral head.
  • the implantation of the balloon can maintain and increase the acromion and humeral head.
  • the distance between the acromion and the humeral head can be directly isolated to prevent the rotator cuff wound from colliding with the bony structure of the acromion, so as to relieve the pain.
  • the raised moment arm can improve the mobility of the shoulder joint, so it can quickly improve the symptoms caused by rotator cuff injury, such as shoulder joint pain and limited joint mobility.
  • rotator cuff injuries can also be treated with mesh.
  • the mesh can be implanted in the shoulder joint and positioned between the tendon and humeral head.
  • One side of the mesh is sutured to the tendon, and the other side is fixed to the humerus
  • the head is equivalent to forming an artificial rotator cuff, and the implantation of the patch can promote the slow healing of the rotator cuff injury.
  • the above are basically the treatment methods for mild rotator cuff injuries.
  • severe (huge) and irreparable rotator cuff injuries there is no fundamental and rapid repair method in related technologies, whether it is the implantation of the buffer part or The implantation of repair part all has the defect of treatment.
  • the therapeutic principle of the buffer part is to isolate the torn rotator cuff, but it does not guide the rotator cuff
  • the buffer part also has long-term failure risks such as displacement and rupture.
  • the implantation of the repaired part is beneficial to the healing of the rotator cuff tissue and remodeling the integrity of the rotator cuff, it is necessary to improve the shoulder joint pain and limited mobility of the shoulder joint caused by the rotator cuff injury. This process is relatively slow, especially for severe rotator cuff injuries, and the pain will be unbearable for patients.
  • rotator cuff injury can be understood as not only treating the symptoms but also the root cause, that is, it can promote the healing of rotator cuff tissue
  • rapid treatment of rotator cuff injury can be understood as quickly relieving the patient's external pain, making the patient's rotator cuff Symptoms such as shoulder joint pain and limited joint mobility caused by the injury were quickly improved. Therefore, this application provides a repair device for the shoulder joint. After the repair device is implanted in the shoulder joint, it can be fixed through a simpler surgical operation.
  • an embodiment of the present application provides a repair device for shoulder joints, including a cushioning part 100, a repairing part 200, and a bordering part 300, and the buffering part 100 can be in a shrinking or expanding state , the cushioning part 100 comprises a cavity, and the cavity is configured to be filled with a substance so that the cushioning part 100 is in an expanded state; a repair part 200 is configured to cover the humeral head or/and tendon; the junction part 300 is located at the repair part 200 On the side away from the humeral head or/and the tendon, the buffer part 100 is movably connected to the repair part 200 through the border part 300 .
  • the shrinking state of the buffer part 100 means that the buffer part 100 can reduce its own volume.
  • the atrophy shape of 100 in the shrunk state is not limited, as long as it meets the delivery requirements.
  • the delivery device uses the delivery catheter to deliver the buffer part 100
  • the atrophied state of the buffer part 100 needs to be adapted to the tubular lumen of the delivery catheter.
  • the strip is contained within the delivery catheter.
  • the expanded state is relative to the shrunken state.
  • the expanded state of the cushioning part 100 means that the buffering part 100 can expand its own volume. It can form an effective support between the acromion and the humeral head, maintain and increase the distance between the acromion and the humeral head, and play a therapeutic effect. It is enough to form an effective support between the peak and the humeral head.
  • the cushioning part 100 in the expanded state is roughly plate-shaped, or the surfaces on both sides of the plate shape have surfaces that gently fit the internal tissue structures of the shoulder joint such as tendon, humeral head, and acromion. shape.
  • the buffer part 100 is movably connected to the repair part 200 through the border part 300, which means that although the buffer part 100 is connected to the repair part 200 through the border part 300, the buffer part 100 still has a certain movable distance relative to the repair part 200. Within the distance, the buffering part 100 can approach or move away from the repairing part 200 , but cannot be further separated from the repairing part 200 beyond the movable distance, so that the buffering part 100 has a certain buffering function.
  • the buffer part 100 and the repair part 200 can be implanted at the same time. Since the buffer part 100 and the repair part 200 have been connected through the border part 300 before implantation, the repair After the device is implanted, the repair part 200 can be directly used to connect the tendon 001 and the humeral head 002, so that the repair part 200 can form a fixation in the tissue of the shoulder joint, and at the same time fix the buffer part 100, thereby realizing the maintenance of the whole repair device.
  • the operation is very simple, only need to fix the repair part 200, and do not need to fix the buffer part 100 during the operation, compared to the need to fix the repair part 200 and fix the buffer during the operation
  • the part 100 can improve the operation efficiency and greatly reduce the discomfort caused by the operation to the patient.
  • the fixation of the repair part 200 connecting the tendon 001 and the humeral head 002 can be realized by rivets with wires and other reasonable forms.
  • the repair part 200 can replace the artificial rotator cuff by connecting the tendon 001 and the humeral head 002.
  • the repair part 200 covers the tendon 001 and humeral head 002 can make muscles grow on the repaired part 200, promote muscle growth, realize the repair of the damaged rotator cuff, and enable the rotator cuff tissue to heal slowly, which can serve the purpose of fundamentally repairing the rotator cuff , so that the rotator cuff gradually returns to its original function during the slow healing process.
  • growth factors, collagen, etc. that can promote muscle growth can also be added to the repaired part 200 .
  • the buffer part 100 After the buffer part 100 is implanted and inflated, it can provide mechanical leverage, prevent the damaged rotator cuff from colliding with the bony structure of the acromion, increase the stability of the glenohumeral joint, and reduce the subacromial pressure, thereby relieving pain and reducing the humerus Move the head 002 upwards, increase the distance between the shoulder and humerus, and then increase the abduction arm of the shoulder joint, which can quickly improve the mobility of the shoulder joint, solve the problems caused by the rotator cuff injury in a short time, and save the patient Suffering from illness.
  • the functions and functions of the cushioning part 100 and the repairing part 200 cooperate to achieve short-term relief of shoulder joint pain and effectively promote slow healing of the rotator cuff, which is suitable for rapid and fundamental healing of severe rotator cuff injuries.
  • the reason why the cushioning part 100 and the repairing part 200 can be implanted together at the predetermined position of the shoulder joint, and only one operation of fixing (fixing the repairing part 200 only) is required is that the buffering part 100 and the repairing part 200 pass through the border before implantation.
  • Section 300 implements pre-connection. Therefore, as long as the connection between the buffer part 100 and the repair part 200 can realize that the entire repair device only needs to be fixed once to complete the operation, the connection between the buffer part 100 and the repair part 200 can be in many different reasonable forms, such as the repair part 200 is detachably connected to the buffer part 100, or the repair part 200 is fixedly connected to the buffer part 100.
  • the detachable connection form can facilitate the separation or connection of the buffer part 100 and the repair part 200 in appropriate situations and periods, while the fixed connection form It is beneficial to the stability of the connection between the buffer part 100 and the repair part 200 , and those skilled in the art can choose an appropriate connection form according to actual surgical requirements, which is not limited here.
  • the structure of the buffer part 100 can be various, for example, as shown in FIG.
  • the surface of the capsule 120 away from the acromion, the area of the border portion 300 is smaller than the surface area of the capsule 120 away from the acromion.
  • the buffer part 100 is an independent capsule body 120 , and the independent capsule body 120 is fixed on the repair part 200 through the border part 300 to complete its fixing.
  • FIG. 1 shows a structure in another structure, as shown in FIG.
  • the cushioning portion 100 includes a capsule body 120 and a capsule body cover 110, the cavity is formed inside the capsule body 120, and the capsule body cover 110 includes an inner space , the capsule body 120 is movably disposed in the inner space (ie, the inner cavity of the capsule body 120 ), the bordering part 300 is disposed on the surface of the capsule body casing 110 away from the acromion, and the capsule body casing 110
  • the cushioning part 100 is formed together with the capsule 120 located in the inner cavity of the capsule casing 110 .
  • the capsule body 120 is movable in the inner cavity of the capsule body jacket 110, and the capsule body jacket 110 is fixed at a predetermined position of the shoulder joint, so that the capsule body jacket 110 can be formed and fixed, and the capsule body 120 can be fixed to a certain extent by using the capsule body jacket 110. Fixing, so that the capsule body 120 cannot break away from the constraint of the capsule body cover 110 , and only allows the capsule body 120 to move within the constraint cavity of the capsule body cover 110 . This not only ensures the fixation of the capsule body 120, but also enables the capsule body 120 to automatically adapt to the activities of the shoulder joint within the allowable range of activities, prolonging the service life of the capsule body 120.
  • the surface of the buffer portion 100 is provided with a protective layer 130 , and the protective layer 130 can be formed in various forms. The surface weave constitutes the protective layer 130 .
  • the repair part 200 is a sheet structure, and the sheet structure is fixed to the humeral head by anchors or sutures.
  • the side of the repair part 200 close to the humeral head 002 contains curved surfaces, depressions or protruding structures, which are used to fit the acromion or the humeral head 002, that is, the shape of the repair part 200 can be tailored according to the shape of the supraspinatus muscle, similar to the supraspinatus muscle
  • the repair part 200 can simulate the shape of the damaged rotator cuff, and form a proper connection between the tendon 001 and the humeral head 002.
  • the repair part 200 is square, and the shape of this square can be a rectangle, or the outer contour can include a semicircle
  • the shape formed by combining the rectangle and the outer contour include other shapes formed by combining the polygon and the rectangle, but it is still generally square and can cover the shape of the tendon 001 and the humeral head 002. Refer to the examples in Figure 11 to Figure 13. Not limited to this.
  • connection length may be the maximum length of the repaired part 200. Enough to cover tendon 001 and humeral head 02. Even if the connection length is not the maximum length of the repair part 200, in order to realize the repair of the severely damaged rotator cuff, the maximum length of the repair part 200 needs to be enough to cover the tendon 001 and the humeral head 02.
  • the square when the repaired part 200 is substantially square, the square can have a length, which can be formed by extending at least one region of the repaired part 200 along one direction, and the range of the length is 20-50 mm, such as the repaired part 200
  • the length can be 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, 50mm, etc.
  • the width of the rectangle can be 20-35mm, for example, the width of the repaired part 200 can be 20mm, 25mm, 30mm, 35mm, etc. Therefore, the repair part 200 can be 20*20, 25*50, 30*30, 30*50, 35*40 and other specifications.
  • the repair part 200 used to cover the tendon 001 and the humeral head 002 can be relatively small relative to the length of the torn rotator cuff wound.
  • the repair part 200 with a length of 20 mm can be completely used for repair.
  • rotator cuff damage is not large Up to 3cm, only 2.5cm, 2.55cm, 2.6cm, 2.65cm, 2.7cm, 2.75cm, 2.8cm, 2.85cm, 2.9cm, 2.95cm, etc., but cannot be effectively treated according to ordinary treatment methods, the repair of this application
  • the device can also be used to treat it.
  • the buffer part 100 and the repair part 200 can also be relatively fixed in a variety of reasonable ways.
  • the surface of the repair part 200 and the surface of the buffer part 100 are fixed by weaving.
  • the repair part 200 may be continuously braided after being formed by knitting, or the buffer part 100 may be continuously braided after the repair part 200 is formed by knitting, or the buffer part 100 and the repair part 200 may be mated directly by knitting. Perform braided fixation.
  • directly weaving the fixed buffer part 100 and the repair part 200 it can be achieved by using braided threads.
  • the area is fixed, so that the surface of the repaired part 200 can be directly braided and fixed with the surface of the buffer part 100 through the braided wire.
  • the direct braided fixing here means that the braided wire is respectively fixed with the surface of the repaired part 200 and the surface of the buffer part 100 through a weaving process. connect.
  • a covering layer can also be woven on the surface of the repaired part 200 through braiding wire, that is, the braided area includes a covering layer formed by weaving the surface of the buffer part through braiding wire.
  • the covering layer is formed by extending and braiding the braided wire from the buffer part to the repair part, and the covering layer fixes and covers the buffer part 100, so as to realize the braiding and fixing of the buffer part 100, or when repairing
  • the portion 200 is formed in a braided manner and then continues to be braided to form the covering.
  • the cushioning portion 100 after the cushioning portion 100 is wrapped in the cladding layer, it can be tightly wrapped or wrapped with a certain degree of looseness, but the looseness cannot be too large, so as not to lose the bondage to the cushioning portion 100 .
  • the material of the braided thread can be selected as polyethylene, titanium alloy or developer-modified yarn, wherein the developer-modified yarn refers to the yarn containing developer, such as barium sulfate, bismuth subcarbonate, bismuth trioxide , bismuth hydroxide, tungsten powder, etc.
  • developer-modified yarn refers to the yarn containing developer, such as barium sulfate, bismuth subcarbonate, bismuth trioxide , bismuth hydroxide, tungsten powder, etc.
  • the junction part 300 includes a hot-melt connection area, and the surface of the repair part 200 and the surface of the buffer part 100 can also be thermally fixed through the hot-melt connection area, for example, by using laser thermal fusion or thermal clamping.
  • the surface of the repaired part 200 and the surface of the buffer part 100 are hot-melted and fixed in a complete area by means of a mold or the like.
  • the area of the hot-melt area can be selected according to the firmness requirements of the fixation. The larger the area of the hot-melt area, the stronger the firmness.
  • the hot-melt fixation of the complete area that is, the surface of the repair part 200 has several hot-melt connection areas, and the hot-melt connection areas are hot-melt fixed to the surface of the buffer part 100, and the several hot-melt connection areas are distributed in a suitable way.
  • the melting connection area is a hot melting point
  • the hot melting fixation of the surface of the repairing part 200 and the buffer part 100 is a multi-point, incomplete area fixing structure.
  • the advantage of this fixing method is that the actual hot melting area can be reduced. However, forming a hot-melt connection at a reasonable position also ensures the firmness of the connection.
  • the adjoining portion 300 includes an adhesive layer, and the surface of the repaired portion 200 and the surface of the buffer portion 100 can also be bonded and fixed through the adhesive layer.
  • the fixation can be fixed by bonding in a complete area or in a non-complete area.
  • the bonding structure can refer to hot-melt fixing, such as forming an adhesive connection similar to a hot-melt connection area area, which will not be described and limited here.
  • the repair device further includes a strap 140, the bordering portion 300 is formed by connecting the strap 140 with the surface of the repaired part near the acromion, and the buffer portion 100 is formed by the strap 140 is fixed on the surface of the repaired part 200 .
  • the two ends of the strap 140 are connected to the surface of the repaired portion 200 to form the border portion 300.
  • other positions of the strap 140 are not limited, so the strap 140 Other positions except its two ends can form a certain space together with the surface of the repair part 200, and this space can be used to place the buffer part 100, so that the strap 140 can bind the buffer part 100 to the repair part 200.
  • the number of straps 140 can be 1, 2, 3 or any number, and the width of the straps 140 can also be determined according to the size of the buffer portion 100, the size of the repair portion 200 and the actual number of straps 140, so as to The buffer part 100 can be stably bound.
  • the materials for the cushioning part 100 and the repairing part 200 can be designed according to actual surgical needs.
  • the buffering part 100 is a non-degradable balloon or a degradable balloon
  • the repairing part 200 is a non-degradable patch, a degradable patch, a biological patch, etc. patch or composite patch.
  • the buffer part 100 can be a degradable capsule
  • the repair part is a non-degradable patch. After the degradable capsule is implanted in the body, the degradable capsule will degrade within a period of time. After the degradable capsule is degraded, The damaged rotator cuff in the shoulder joint can be repaired with non-degradable patch to achieve healing of the rotator cuff and improve the function of the shoulder joint.
  • the degradable capsule can be automatically degraded in the body, the degradable capsule will also remain in the body for a period of time, which is enough to repair the damaged rotator cuff. After the degradable capsule is degraded, the damaged rotator cuff in the general shoulder joint The repair can already be realized by the prosthetic part 200, so the activity function of the shoulder joint can still be improved.
  • the material of the non-degradable patch is polyester, polypropylene or polytetrafluoroene
  • the material of the degradable patch is polyglycolic acid or polyglycolic acid
  • the material of the biological patch is allogeneic tissue graft or autologous tissue graft.
  • the type of patch is a collagen-coated polyester patch, polypropylene patch, polytetrafluoroethylene patch, polyglycolic acid patch, or polyglycolic acid patch.
  • the present application also provides a prosthesis system, including a prosthetic device.
  • the prosthesis system also includes a delivery device, which is connected to the repair device and is used to deliver the repair device.
  • the repair device can be delivered to the target position of the human body according to the implantation requirements of the repair device, for example, it can be connected to the buffer part 100 .
  • the function of the delivery device is to smoothly implant the repair device into the predetermined position in the human body.
  • the delivery device can use the existing device, as long as it can meet the smooth implantation of the above-mentioned repair device. As for the specific structure and model of the delivery device, here No limit.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rehabilitation Therapy (AREA)
  • Rheumatology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

一种用于肩关节的修复装置以及假体系统，修复装置包括：缓冲部(100)，可呈萎缩状态或膨胀状态，缓冲部(100)包含空腔，空腔被配置为用于填充物质以使缓冲部呈膨胀状态；修补部(200)，被配置为用于覆盖肱骨头和肌腱；接壤部(300)，位于修补部远离肱骨头和肌腱一侧，缓冲部(100)通过接壤部(300)与修补部(200)可动连接。

Description

用于肩关节的修复装置以及假体系统 技术领域
本申请涉及医疗器械技术领域，特别是涉及一种用于肩关节的修复装置以及假体系统。
背景技术
肩袖是连接肩胛骨和肱骨头的肌肉-肌腱结构，位于肩关节囊的外层，三角肌的内层。肩袖由前肩袖(肩胛下肌)、上肩袖(冈上肌)、后肩袖(冈下肌和小圆肌)构成，肩袖除了有一定的使上臂内旋、外旋和外展的功能，更主要的功能是能稳定肱骨头在关节盂上的位置，避免肱骨头上移撞击肩峰造成疼痛等。因此，肩袖在肩关节的稳定性的维持以及肩关节的活动过程中，均扮演着极其重要的角色。
然而随着年龄增长，长期反复的肩关节活动、肩峰下骨质增生、或是反复剧烈的活动，均可能造成肩峰下软组织(关节滑囊、肩袖)的磨损、撕裂，使得肱骨头的稳定性、活动性受损，在肩关节活动过程中患者手臂无法外展、上举等，并由于骨质间或骨质与肩袖的撞击带来剧烈的疼痛，还会导致患者因疼痛而夜不能眠，严重影响生活质量以及自理能力。
目前，肩袖损伤治疗方式主要包括肩袖部分修补、肩袖重建、局部肌肉转移、上关节囊重建、反式肩关节置换等。对于程度较轻的肩袖损伤，一般手术可获得较好的治疗结果，但对于重度(大于3cm的损伤)且不可修复的肩袖损伤，现有治疗方式暂时还难以达到根本、快速的修复效果。
发明内容
根据本申请的各种实施例，本申请提供了一种用于肩关节的修复装置，包括：
缓冲部，可呈萎缩状态或膨胀状态，所述缓冲部包含空腔，所述空腔被配置为用于填充物质以使所述缓冲部呈所述膨胀状态；
修补部，被配置为用于覆盖肱骨头和肌腱中的至少一者；及
接壤部，所述接壤部位于所述修补部远离所述肱骨头和肌腱中至少一者的一侧，所述缓冲部通过所述接壤部与所述修补部可动连接。
一方面，所述缓冲部包含囊体，所述囊体内部形成所述空腔，所述接壤部设置于所述囊体远离肩峰一侧表面，所述接壤部面积小于所述囊体远离肩峰一侧表面面积。
一方面，所述缓冲部包含囊体、囊体外套，所述囊体内部形成所述空腔，所述囊体外套包含一内空间，所述囊体可移动地设置于所述内空间，所述接壤部设置于所述囊体外套远离肩峰一侧表面。
一方面，所述修补部为片状结构，所述片状结构通过锚钉或缝线固定于所述肱骨头。
一方面，所述接壤部包含编织区，所述修补部的表面与所述缓冲部的表面通过所述编织区固定。
一方面，所述编织区包含所述缓冲部表面通过编织线编织形成的包覆层的至少部分，所述包覆层通过所述编织线从所述缓冲部延伸编织至所述修补部形成。
一方面，所述编织线的材料为聚乙烯、钛合金或显影剂改性纱线。
一方面，所述接壤部包含热熔连接区域，所述修补部的表面与所述缓冲部的表面通过所述热熔连接区域热熔固定。
一方面，所述接壤部包含胶粘层，所述修补部的表面与所述缓冲部的表面通过所述胶粘层粘接固定。
一方面，还包括：
绑带，所述接壤部通过所述绑带与修补部靠近肩峰一侧表面连接形成，所述缓冲部通过所述绑带固定在所述修补部上。
一方面，所述缓冲部为不可降解囊体或可降解囊体。
一方面，所述修补部为不可降解补片、可降解补片、生物补片或复合型补片。
一方面，所述缓冲部为可降解囊体，且所述修补部为不可降解补片。
一方面，所述修补部靠近肱骨头一侧包含曲面、凹陷或突出结构，用于与肩峰或肱骨头相适配。
一方面，所述修补部类方形，所述修补部的长度约20mm至约50mm。
本申请提供了一种假体系统，包括：
所述修复装置；
输送装置，与所述修复装置连接，用于输送所述修复装置。
上述用于肩关节的修复装置，由于缓冲部与修补部在植入前已经形成连接，所以修复装置植入后，可以直接利用修补部连接肌腱和肱骨头，修补部可因此而在肩关节的组织内形成固定，同时也将缓冲部进行固定，进而实现对整个修复装置的固定，手术操作十分简便，只需要固定修补部即可，并不需要在手术过程中进行缓冲部的固定操作，相对于在一台手术过程中既需要固定修补部、又需要固定缓冲部，可以大大降低手术对患者造成的不适感。在固定后不仅可以利用修补部辅助肩袖组织的愈合、重塑肩袖完整性，而且还能够利用缓冲部快速改善肩袖损伤带来的肩关节疼痛和肩关节活动能力受限的问题，使患者快速摆脱伤病困扰，实现对重度肩袖损伤问题的根本、快速治疗。
附图说明
为了更清楚地说明本申请实施例或相关技术中的技术方案，下面将对实施例或相关技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲， 在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本申请一些实施例中的用于肩关节的修复装置的使用状态示意图；
图2为本申请一些实施例中的用于肩关节的修复装置的截面示意图；
图3为本申请一些实施例中的用于肩关节的修复装置的平面示意图；
图4为本申请一些实施例中的囊体外套和囊体的配合结构示意图；
图5为本申请一些实施例中的用于肩关节的修复装置具有保护层的结构示意图。
图6为本申请一些实施例中的用于肩关节的修复装置的包覆层连接截面示意图；
图7为本申请一些实施例中的用于肩关节的修复装置的热熔连接截面示意图；
图8为本申请一些实施例中的用于肩关节的修复装置的粘接连接截面示意图；
图9为本申请一些实施例中的用于肩关节的修复装置的绑带连接截面示意图；
图10为本申请一些实施例中的用于肩关节的修复装置的绑带连接平面示意图；
图11为本申请一些实施例中的修补部的一个形状示意图；
图12为本申请一些实施例中的修补部的另一个形状示意图；
图13为本申请一些实施例中的修补部的又一个形状示意图。
附图标记：
001、肌腱；002、肱骨头。
100、缓冲部；200、修补部；300、接壤部；
110、囊体外套；120、囊体；130、保护层；140、绑带。
具体实施方式
为使本申请的上述目的、特征和优点能够更加明显易懂，下面结合附图对本申请的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本申请。但是本申请能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本申请内涵的情况下做类似改进，因此本申请不受下面公开的具体实施例的限制。
在本申请的描述中，需要理解的是，术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。
此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本申请的描述中，“多个”的含义是至少两个，例如两个，三个等，除非另有明确具体的限定。
在本申请中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系，除非另有明确的限定。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本申请中的具体含义。
在本申请中，除非另有明确的规定和限定，第一特征在第二特征“上”或“下”可以是第一和第二特征直接接触，或第一和第二特征通过中间媒介间接接触。而且，第一特征在第二特征“之上”、“上方”和“上面”可是第一特征在第二特征正上方或斜上方，或仅仅表示第一特征水平高度高于第二 特征。第一特征在第二特征“之下”、“下方”和“下面”可以是第一特征在第二特征正下方或斜下方，或仅仅表示第一特征水平高度小于第二特征。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“上”、“下”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。
对于肩袖损伤而言，可以采用球囊治疗，球囊直接植入到肩关节位置，并使球囊位于肩峰与肱骨头之间，球囊的植入可以维持、增加肩峰与肱骨头之间的距离，从而直接隔绝撕裂的肩袖，防止肩袖伤口与肩峰的骨性结构产生撞击，以此缓解疼痛，同时经过重建肩峰与肱骨头之间的距离，增加肩关节上举的力臂，改善肩关节活动能力，因此可以对肩袖损伤所带来的症状，如肩关节疼痛和关节活动受限进行快速改善。另外，对于肩袖损伤也可以采用补片治疗，补片可以植入到肩关节位置，并使补片位于肌腱和肱骨头之间，补片的一侧与肌腱缝合，另一侧固定于肱骨头，相当于形成人工肩袖，补片的植入可以促进肩袖损伤部位缓慢愈合。
但是，以上基本都是对于轻度肩袖损伤采取的治疗方式，对于重度(巨大)且不可修复的肩袖损伤，相关技术中并没有根本、快速的修复手段，无论是缓冲部的植入还是修补部的植入，都存在治疗的缺陷。对于缓冲部而言，缓冲部虽然能够快速改善肩袖损伤带来的肩关节疼痛和肩关节活动能力受限，但是缓冲部的治疗原理是隔绝撕裂的肩袖，但并不会引导肩袖上的肌腱进行修复，因此实际上并无法使肩袖组织愈合，尤其是对于重度肩袖损伤，撕裂部分会长期处于病患状态。而且，缓冲部也存在移位、破裂等远期失效风险。对于修补部而言，修补部的植入虽然有利于肩袖组织的愈合、重塑肩袖完整性，但是改善肩袖损伤带来的肩关节疼痛和肩关节活动能力受限需要随着肩袖的逐步愈合才能实现，这一过程是比较缓慢的，尤其是对于重度肩袖损伤，疼痛感会使患者难以承受。
需要说明的是，根本治疗肩袖损伤可以理解为不仅治标而且治本，即针对肩袖组织的愈合具有促进效果，快速治疗肩袖损伤可以理解为快速缓解患者的外在疼痛感，使因肩袖损伤带来的肩关节疼痛和关节活动受限等症状得到快速改善。所以，本申请提供了一种用于肩关节的修复装置，该修复装置植入到肩关节位置后，可以通过更为简易的手术操作进行固定，在固定后不仅可以辅助肩袖组织的愈合、重塑肩袖完整性，而且还能够快速改善肩袖损伤带来的肩关节疼痛和肩关节活动能力受限的问题，使患者快速摆脱伤病困扰，并持续辅助肩袖组织愈合，实现对重度肩袖损伤问题的根本、快速治疗。
参阅图1至图3所示，本申请一实施例提供了一种用于肩关节的修复装置，包括一缓冲部100、修补部200、接壤部300，缓冲部100可呈萎缩状态或膨胀状态，缓冲部100包含一空腔，空腔被配置为用于填充物质以使缓冲部100呈膨胀状态；一修补部200被配置为用于覆盖肱骨头或/和肌腱；接壤部300位于修补部200远离肱骨头或/和肌腱一侧，缓冲部100通过接壤部300与修补部200可动连接。
缓冲部100的萎缩状态表示缓冲部100可以缩小其本身体积，缩小的程度主要取决于输送需求，保证缓冲部100的体积缩小至能够被容纳在输送装置内，被顺利输送至预定位置，缓冲部100呈萎缩状态时的萎缩形状不限，只要满足输送需求即可，例如，输送装置利用输送导管输送缓冲部100时，缓冲部100的萎缩状态便需要与输送导管的管状内腔适配，呈长条状被容纳在输送导管内。
相应的，膨胀状态是相对于萎缩状态而言的，缓冲部100的膨胀状态表示缓冲部100可以扩大其本身体积，扩大的程度主要取决于肩关节的修复需求，保证缓冲部100的体积扩大后能够在肩峰与肱骨头之间形成有效支撑，得以维持、增加肩峰与肱骨头之间的距离，起到治疗的效果，缓冲部100呈膨胀状态时的膨胀形状不限，只要满足在肩峰与肱骨头之间形成有效支撑即可，例如，膨胀状态的缓冲部100为大致板状、或板状两侧表面具有温柔贴合肌腱、肱骨头、肩峰等肩关节内组织结构的表面形状。
缓冲部100通过接壤部300与修补部200可动连接表示缓冲部100虽然经接壤部300连接在修补部200，但是缓冲部100相对于修补部200仍旧具有一定的可活动距离，在该可活动距离内，缓冲部100可以相对于修补部200靠近或远离，但是不能够超过该可活动距离而进一步脱离修补部200，如此使缓冲部100具有一定的缓冲功能。
该修复装置植入到肩关节的预定位置时，可以一并将缓冲部100和修补部200同时植入，由于缓冲部100与修补部200在植入前已经通过接壤部300形成连接，所以修复装置植入后，可以直接利用修补部200连接肌腱001和肱骨头002，修补部200可因此而在肩关节的组织内形成固定，同时也将缓冲部100进行固定，进而实现对整个修复装置的固定，手术操作十分简便，只需要固定修补部200即可，并不需要在手术过程中进行缓冲部100的固定操作，相对于在一台手术过程中既需要固定修补部200、又需要固定缓冲部100，可以提高手术效率，及大大降低手术对患者造成的不适感。
修补部200连接肌腱001和肱骨头002的固定可以采用带线的铆钉以及其他合理的形式实现，修补部200通过将肌腱001和肱骨头002进行连接，可以代替人工肩袖，修补部200覆盖肌腱001和肱骨头002，可以使肌肉生长在修补部200上，促进肌肉生长、实现对受损肩袖的修复，使肩袖组织能够缓慢的愈合，这种愈合可以起到根本修复肩袖的目的，使肩袖在缓慢的愈合过程中逐渐恢复原本的功能。为了促进肌肉的快速生长，修补部200中还可以添加可以促进肌肉生长的生长因子、胶原等。
缓冲部100植入并充盈后，能够提供力学杠杆作用，防止受损肩袖与肩峰的骨性结构发生撞击，增加盂肱关节的稳定性，降低肩峰下压力，从而缓解疼痛、减少肱骨头002上移、增加肩-肱之间的距离，进而增加肩关节的外展力臂，可以达到快速改善肩关节的活动能力，在短时间内解决肩袖损伤带来的问题，使患者免受病痛困扰。缓冲部100和修补部200的功能、作用相配合，能够在短期内实现肩关节疼痛的缓解，并有效促进肩袖缓慢愈合，适用于重度肩袖损伤的快速、根本治愈。
缓冲部100和修补部200之所以能够一并植入肩关节的预定位置，且仅需要一次固定(仅固定修补部200)的手术操作，在于缓冲部100和修补部200在植入前通过接壤部300实现了预先连接。因此只要缓冲部100和修补部200的连接能够实现整个修复装置仅需要一次固定就能完成手术操作，那么缓冲部100和修补部200之间的连接可以为多种不同的合理形式，例如修补部200与缓冲部100可拆卸连接，或者，修补部200与缓冲部100固定连接，可拆卸的连接形式可以方便缓冲部100和修补部200在适当的情况、时段分离或连接，而固定的连接形式有利于缓冲部100和修补部200之间的连接稳定性，本领域技术人员可以根据实际手术需求选用合适的连接形式，在此不做限定。
缓冲部100的结构形式可以为多种，例如，参阅图2所示，所述缓冲部100包含一囊体120，所述囊体120内部形成所述空腔，所述接壤部300设置于所述囊体120远离肩峰一侧表面，所述接壤部300面积小于所述囊体120远离肩峰一侧表面面积。此时缓冲部100为独立的囊体120，独立的囊体120通过接壤部300固定在修补部200上即可完成对其的固定。另一种结构中，参阅图4所示，所述缓冲部100包含一囊体120、囊体外套110，所述囊体120内部形成所述空腔，所述囊体外套110包含一内空间，所述囊体120可移动地设置于所述内空间(即囊体120的内腔)，所述接壤部300设置于所述囊体外套110远离肩峰一侧表面，由囊体外套110和位于囊体外套110内腔中的囊体120共同构成缓冲部100。
囊体120活动至于囊体外套110的内腔中，囊体外套110固定在肩关节的预定位置，可以使囊体外套110形成固定，并利用囊体外套110将囊体120在一定程度上进行固定，使囊体120不能够脱离囊体外套110的束缚，仅允许囊体120在囊体外套110的束缚腔内活动。这既保证了对囊体120的固定，又可以使囊体120在允许活动的范围内自动适应肩关节的活动，延长囊体120的使用寿命。另外，参阅图5所示，缓冲部100的表面设置有保护层130，保护层130可以采用多种形式形成，例如保护层130可以通过套在缓冲部100 上形成，也可以在缓冲部100的表面编织构成保护层130。
所述修补部200为片状结构，所述片状结构通过锚钉或缝线固定于所述肱骨头。修补部200靠近肱骨头002一侧包含曲面、凹陷或突出结构，用于与肩峰或肱骨头002相适配，即，修补部200的形状可以依据岗上肌的形状裁剪，类岗上肌的修补部200可以模拟受损肩袖的形状，在肌腱001和肱骨头002之间形成合适的连接，修补部200类方形，且该类方形的形状可以为矩形，也可以是外轮廓包括半圆和矩形相结合构成的形状、外轮廓包括其他多边形与矩形相结合构成的形状，但大体上仍旧为方形，可以覆盖肌腱001和肱骨头002的形状，可参阅图11至图13的举例，在不限于此。
本领域技术人员可以根据实际需求或医生根据需求裁剪修补部200的形状，在此不做限定。而无论大致的方形实际为何种形状，大致的方形在连接肌腱001和肱骨头002之间时会需要一定的连接长度，该连接长度可能是修补部200的最大长度，那么此时该连接长度需要足够覆盖肌腱001和肱骨头02。即便该连接长度不是修补部200的最大长度，那么为了能够实现对重度损伤的肩袖的修复，所以修补部200的最大长度也需要足够覆盖肌腱001和肱骨头02。
举例说明，当修补部200为大致方形时，方形可以具有长度，该长度可以为修补部200的至少一个区域沿着一个方向延伸而构成，该长度的范围在20-50mm，如修补部200的长度可以为20mm、25mm、30mm、35mm、40mm、45mm、50mm等。对于规则的方形，如矩形，此时矩形的宽度可以为20-35mm，如修补部200的宽度可以为20mm、25mm、30mm、35mm等。因此，修补部200可以为20*20、25*50、30*30、30*50、35*40等规格。因为肌腱001具有牵伸延展效果，所以用于覆盖肌腱001和肱骨头002的修补部200可以相对于撕裂的肩袖伤口长度较小，如修补部200的长度虽然为20mm，但在修补大于3cm的肩袖损伤时，如果将肌腱001朝向肱骨头002牵伸延展，则完全可以利用20mm长的修补部200实现修补。
由前文记载可知，对于轻度肩袖损伤，相关技术中已经具备相对合适且 有效的治疗方式，本申请提供的修复装置本质上针对的是重度肩袖损伤的治疗。理论上在肩袖损伤的程度划分中，肩袖损伤大于3cm属于重度，肩袖损伤小于3cm属于轻度，但是实际上肩袖的损伤为轻为重还需要考量实际的治疗难度。虽然本申请中的修复装置声称针对的是3cm及以上的肩袖损伤，但并不代表本申请的修复装置不适用于略小于3cm的肩袖损伤的治疗，例如，虽然肩袖损伤的大小未达3cm，只有2.5cm、2.55cm、2.6cm、2.65cm、2.7cm、2.75cm、2.8cm、2.85cm、2.9cm、2.95cm等，但是依照普通的治疗手段无法有效治疗时，本申请的修复装置也能够用来对其进行治疗。
对于固定连接的形式，其实缓冲部100和修补部200也可以通过多种合理的方式相对固定，例如，修补部200的表面与缓冲部100的表面编织固定，编织的形式可以是缓冲部100以编织的方式成形后继续编织连接修补部200，也可以是修补部200以编织的方式成形后继续编织连接缓冲部100，或者也可以是直接通过编织的形式对配合的缓冲部100和修补部200进行编织固定。在直接编织固定缓冲部100和修补部200时，可以采用编织线的实现，例如所述接壤部300包含一编织区，所述修补部200的表面与所述缓冲部100的表面通过所述编织区固定，由此可以将修补部200的表面通过编织线与缓冲部100的表面直接编织固定，这里的直接编织固定指编织线分别与修补部200的表面及缓冲部100的表面通过编织工艺固定连接。
除此之外，参阅图6所示，还可以在修补部200的表面通过编织线编织出包覆层，即所述编织区包含所述缓冲部表面通过编织线编织形成的一包覆层的至少部分，所述包覆层通过所述编织线从所述缓冲部延伸编织至所述修补部形成，包覆层固定包覆缓冲部100，以实现对缓冲部100的编织固定，或者在修补部200以编织的方式成形后继续编织以形成包覆层。此时缓冲部100被包裹在包覆层内后，可以是紧密包裹也可以是具有一定程度的宽松度的包裹，但宽松度不能够过大，以免丧失对缓冲部100的束缚。
编织线的材料可以选择为聚乙烯、钛合金或显影剂改性纱线，其中，显影剂改性纱线表示含有显影剂的纱线，如含有硫酸钡、碱式碳酸铋、三氧化 二铋、氢氧化铋、钨粉等的纱线。
或者参阅图7所示，所述接壤部300包含热熔连接区域，还可以将修补部200的表面与缓冲部100的表面通过热熔连接区域热熔固定，例如利用激光热熔、热卡位模具等方式将修补部200的表面与缓冲部100的表面形成完整区域的热熔固定。热熔区域的面积可以根据需要固定的牢固性要求选择，热熔区域的面积越大则牢固性越强，除此之外，修补部200的表面与缓冲部100的表面之间也可以采用非完整区域的热熔固定，即修补部200的表面具有若干热熔连接区域，热熔连接区域与缓冲部100的表面热熔固定，将若干热熔连接区域以合适的方式分布，若每个热熔连接区域为一个热熔点位，修补部200的表面与缓冲部100的表面的热熔固定便是多点、非完整区域的固定结构，这种固定方式的好处是可以降低实际热熔面积，但在合理的位置形成热熔连接，同样保证了连接牢固性。
继续参考图8所示，与热熔固定的方式相似的，所述接壤部300包含胶粘层，还可以将修补部200的表面与缓冲部100的表面通过胶粘层粘接固定，粘接固定既可以采用完整区域粘接固定，也可以采用非完整区域粘接固定，除了粘接的实际方式不同，粘接的结构可以参考热熔固定，如形成类似于热熔连接区域的粘接连接区，在此不做赘述和限定。
参阅图9和图10所示，修复装置还包括绑带140，所述接壤部300通过所述绑带140与修补部靠近肩峰一侧表面连接形成，所述缓冲部100通过所述绑带140固定在所述修补部200的表面。其中，绑带140的两端连接在修补部200的表面后形成接壤部300，其实除了绑带140的两端，绑带140的除其两端的其他位置是不受限制的，因此绑带140上除其两端的其他位置，便可以与修补部200的表面共同构成一定的空间，该空间可以用来置入缓冲部100，因而绑带140便可以将缓冲部100绑在修补部200上。绑带140的数量可以为1个、2个、3个或任意多个，绑带140的宽度也可以根据缓冲部100的尺寸、修补部200的尺寸以及绑带140的实际数量来确定，以能够稳定绑住缓冲部100为准。
缓冲部100和修补部200的制作材料均可以根据实际手术需求设计，例如，缓冲部100为不可降解球囊或可降解球囊，修补部200为不可降解补片、可降解补片、生物补片或复合型补片。可以采用所述缓冲部100为可降解囊体，且所述修补部为不可降解补片，可降解囊体植入体内后，可降解囊体会在一段时间内降解，可降解囊体降解后，肩关节内受损的肩袖可以通过不可降解补片辅助修复，实现对肩袖的愈合，改善肩关节的活动功能。可降解囊体虽然能够在体内自动降解，但是可降解囊体也会在体内留存一段时间，足以满足受损的肩袖修复，可降解囊体在降解后，一般肩关节内受损的肩袖已经能够通过修补部200实现修复，因此依然可以改善肩关节的活动功能。
不可降解补片的材料为聚酯、聚丙烯或聚四氟烯，可降解补片的材料为聚羟基乙酸或聚乙醇酸，生物补片的材料为异体组织移植物或自体组织移植物，复合型补片为具有胶原涂层的聚酯补片、聚丙烯补片、聚四氟烯补片、聚羟基乙酸补片或聚乙醇酸补片。
本申请还提供了一种假体系统，包括修复装置。假体系统还包括输送装置，输送装置与所述修复装置连接，用于输送所述修复装置，可以根据修复装置的植入需求将修复装置输送至人体的目标位置，例如可以与缓冲部100连接。输送装置的作用是将修复装置顺利植入到人体内的预定位置，输送装置可以采用现有装置，只要能够满足对上述修复装置的顺利植入即可，至于输送装置的具体结构和型号在此不做限定。
以上实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。

Claims (16)

  1. 一种用于肩关节的修复装置，其特征在于，包括：
    缓冲部，可呈萎缩状态或膨胀状态，所述缓冲部包含空腔，所述空腔被配置为用于填充物质以使所述缓冲部呈所述膨胀状态；
    修补部，被配置为用于覆盖肱骨头和肌腱中的至少一者；及
    接壤部，所述接壤部位于所述修补部远离所述肱骨头和肌腱中至少一者的一侧，所述缓冲部通过所述接壤部与所述修补部可动连接。
  2. 根据权利要求1所述的用于肩关节的修复装置，其特征在于，所述缓冲部包含囊体，所述囊体内部形成所述空腔，所述接壤部设置于所述囊体远离肩峰一侧表面，所述接壤部面积小于所述囊体远离肩峰一侧表面面积。
  3. 根据权利要求1所述的用于肩关节的修复装置，其特征在于，所述缓冲部包含囊体、囊体外套，所述囊体内部形成所述空腔，所述囊体外套包含一内空间，所述囊体可移动地设置于所述内空间，所述接壤部设置于所述囊体外套远离肩峰一侧表面。
  4. 根据权利要求1所述的用于肩关节的修复装置，其特征在于，所述修补部为片状结构，所述片状结构通过锚钉或缝线固定于所述肱骨头。
  5. 根据权利要求1所述的用于肩关节的修复装置，其特征在于，所述接壤部包含编织区，所述修补部的表面与所述缓冲部的表面通过所述编织区固定。
  6. 根据权利要求5所述的用于肩关节的修复装置，其特征在于，所述编织区包含所述缓冲部表面通过编织线编织形成的包覆层的至少部分，所述包覆层通过所述编织线从所述缓冲部延伸编织至所述修补部形成。
  7. 根据权利要求6所述的用于肩关节的修复装置，其特征在于，所述编织线的材料为聚乙烯、钛合金或显影剂改性纱线。
  8. 根据权利要求1所述的用于肩关节的修复装置，其特征在于，所述接壤部包含热熔连接区域，所述修补部的表面与所述缓冲部的表面通过所述热熔连接区域热熔固定。
  9. 根据权利要求1所述的用于肩关节的修复装置，其特征在于，所述接壤部包含胶粘层，所述修补部的表面与所述缓冲部的表面通过所述胶粘层粘接固定。
  10. 根据权利要求1所述的用于肩关节的修复装置，其特征在于，还包括：
    绑带，所述接壤部通过所述绑带与修补部靠近肩峰一侧表面连接形成，所述缓冲部通过所述绑带固定在所述修补部上。
  11. 根据权利要求1-10中任一项所述的用于肩关节的修复装置，其特征在于，所述缓冲部为不可降解囊体或可降解囊体。
  12. 根据权利要求1-10中任一项所述的用于肩关节的修复装置，其特征在于，所述修补部为不可降解补片、可降解补片、生物补片或复合型补片。
  13. 根据权利要求1-10中任一项所述的用于肩关节的修复装置，其特征在于，所述缓冲部为可降解囊体，且所述修补部为不可降解补片。
  14. 根据权利要求1-10中任一项所述的用于肩关节的修复装置，其特征在于，所述修补部靠近肱骨头一侧包含曲面、凹陷或突出结构，用于与肩峰或肱骨头相适配。
  15. 根据权利要求1-10中任一项所述的用于肩关节的修复装置，其特征在于，所述修补部类方形，所述修补部的长度约20mm至约50mm。
  16. 一种假体系统，其特征在于，包括：
    如权利要求1-15中任一项所述的修复装置；
    输送装置，与所述修复装置连接，用于输送所述修复装置。
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