CN216136115U - Prosthesis protection device and combined prosthesis - Google Patents

Abstract

The utility model relates to a combined prosthesis and a prosthesis protection device thereof, comprising: the balloon is provided with an inner cavity and an opening communicated with the inner cavity to form an expandable and contractible structure, and the inner cavity is used for accommodating the inflated rotator cuff balloon; an anchor connected to the pouch, the anchor having at least one free portion. The prosthetic shield is adapted to be applied externally to the rotator cuff balloon and secured to a predetermined location of a shoulder joint, such as the humerus or acromion, by the free portion of the anchor. The protection device can fix the rotator cuff saccule to a certain extent, so that the rotator cuff saccule can not be separated from the constraint of the protection device. Meanwhile, the rotator cuff saccule has relative movement space in the protection device. Thereby not only ensuring the fixation of the rotator cuff saccule and avoiding the rotator cuff saccule from dislocation to cause failure; but also can lead the rotator cuff saccule to automatically adapt to the movement of the shoulder joint within the range of allowable movement, thus prolonging the service life of the rotator cuff saccule.

Description

Prosthesis protection device and combined prosthesis

Technical Field

The utility model relates to the technical field of medical instruments, in particular to a prosthesis protection device and a combined prosthesis with the same.

Background

The rotator cuff is a muscle-tendon structure connecting the scapula and the humerus, and is located on the outer layer of the shoulder joint capsule and the inner layer of the deltoid. The rotator cuff consists of a front rotator cuff (subscapularis), an upper rotator cuff (supraspinatus and subscapularis) and a rear rotator cuff (subscapularis and teres minor), and the rotator cuff has certain functions of enabling the upper arm to rotate inwards, outwards and abduct, and has the more main functions of stabilizing the position of the humerus on the glenoid during the movement process, maintaining the arm of force of muscles, avoiding the humerus from moving upwards and impacting the acromion to cause pain and the like. Therefore, the rotator cuff plays an extremely important role in maintaining the stability of the shoulder joint and in moving the shoulder joint.

However, with the age, the wear and tear of soft tissues under the acromion (joint bursa and rotator cuff) can be caused by long-term repeated shoulder joint activity, hyperosteogeny under the acromion, or repeated violent activity, so that the stability and the mobility of the humerus are damaged, the arm of a patient cannot be abducted or lifted during the shoulder joint activity, severe pain is caused by the impact of sclerotin or sclerotin with the rotator cuff, and the patient cannot sleep at night due to pain, thereby seriously affecting the quality of life and the self-care ability.

At present, the pain caused by rotator cuff injury can be treated by implanting a prosthesis (such as a rotator cuff) which can be implanted between the acromion and the humeral head to maintain and increase the distance between the acromion and the humeral head and play a role of a 'lever' between the humeral head and the fracture surface of the tendon, thereby preventing the injured rotator cuff from colliding with the bony structure of the acromion, increasing the stability of the glenohumeral joint and reducing the downward pressure of the acromion, thereby relieving the pain, reducing the upward movement of the humeral head, increasing the shoulder-humeral distance, increasing the abduction force arm of the shoulder joint and rapidly improving the mobility of the shoulder joint.

However, after the existing prosthesis is implanted into the shoulder joint, the existing prosthesis is continuously worn along with the movement of the shoulder joint, so that the service life of the prosthesis is reduced.

SUMMERY OF THE UTILITY MODEL

In view of the above, there is a need to provide a protection device for an inflated rotator cuff balloon and a combined prosthesis with such a protection device, which addresses the problem of reduced service life of the prosthesis.

The utility model provides a prosthesis protection device, comprising: the balloon is provided with an inner cavity and an opening communicated with the inner cavity to form an expandable and contractible structure, and the inner cavity is used for accommodating the inflated rotator cuff balloon; an anchor connected to the pouch, the anchor having at least one free portion; a stiffener configured to create or enhance a fixation between the anchor and the capsular bag.

The prosthesis protection device is applied externally to the rotator cuff balloon and fixed to a predetermined position of the shoulder joint, such as the humerus or acromion, by the free portion of the anchor. The protection device can fix the rotator cuff saccule to a certain extent, so that the rotator cuff saccule can not be separated from the constraint of the protection device. Meanwhile, the rotator cuff saccule has relative movement space in the protection device. Thereby not only ensuring the fixation of the rotator cuff saccule and avoiding the rotator cuff saccule from dislocation to cause failure; but also can lead the rotator cuff saccule to automatically adapt to the movement of the shoulder joint within the range of allowable movement, thus prolonging the service life of the rotator cuff saccule.

In one embodiment, the anchor is connected to the capsular bag by a connection point, the fastener being provided at the connection point and at a fixation area of the capsular bag.

In one embodiment, the stiffener is disposed around the bladder; alternatively, the stiffener is sleeved over the bladder to cover at least a portion of the bladder.

In one embodiment, the fastener is woven into engagement with the outer surface of the pouch.

In one embodiment, the anchor is in braided fixation with the pouch; alternatively, the anchor is integrally formed with the pouch by a knitting process.

In one embodiment, the fastener is a hot melt layer, and the hot melt layer is arranged at the fixing area of the connecting point and the pouch.

In one embodiment, the connection points include two connection points formed between the anchors and the capsular bag, the anchors each having the free portion; the two connecting points are connected through a reinforcing piece, and the reinforcing piece is connected with the bag.

A prosthesis protection device adapted for an inflatable rotator cuff balloon, comprising: the balloon is provided with an inner cavity and an opening communicated with the inner cavity to form an expandable and contractible structure, and the filling type rotator cuff balloon can be movably accommodated in the inner cavity; an anchor connected to the pouch by a connecting segment, the anchor having at least one free portion.

In one embodiment, the connecting segment is connected to the pouch in at least two directions.

In one embodiment, the connecting segment has a width greater than the width of the anchor at portions of the anchor other than the connecting segment.

In one embodiment, the connecting segment is a local position on the anchor, and two free portions exposed to the outside of the capsular bag are formed on the anchor on both sides of the connecting segment. In one embodiment, the connecting section is attached to the outer surface of the pouch through the side of the pouch away from the acromion, and the length of the connecting section is greater than the distance between the two free portions and the dividing point of the connecting section; or the connecting section is arranged in the bag in a penetrating way.

In one embodiment, a reinforcing member is further included between the connecting section and the bladder for reinforcing the connecting section and the bladder.

A composite prosthesis comprising: the prosthesis shield apparatus; the inflatable rotator cuff balloon can be movably contained in the inner cavity after being inflated by substances but cannot exit the inner cavity through the opening.

Drawings

FIG. 1 is a schematic structural view of a protection device according to an embodiment of the present invention;

FIG. 2 is a schematic structural view of a composite prosthesis according to an embodiment of the present invention;

FIG. 3 is a schematic structural view of a guard according to another embodiment of the present invention;

FIG. 4 is a schematic structural view of a guard according to yet another embodiment of the present invention;

FIG. 5 is a schematic structural view of a guard according to yet another embodiment of the present invention;

FIG. 6 is a schematic structural view of a guard according to yet another embodiment of the present invention;

FIG. 7 is a schematic structural view of a guard according to yet another embodiment of the present invention;

fig. 8 is a schematic structural view of a protection device in another embodiment of the present invention.

Reference numerals:

100, respectively; a guard; 10. a pouch; 110. an inner cavity; 120. an opening; 20. an anchor; 210. a connection point; 220. a free portion; 230. a connecting section; 240. a demarcation point; 40. a firmware; 200. a rotator cuff balloon.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the utility model and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the utility model.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature may be directly under or obliquely under the first feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

The rotator cuff balloon is a prosthesis specially used for treating shoulder joint injury (rotator cuff injury, tear), can be implanted into a shoulder joint part of a patient through a conveying device and is fixed at a position between a acromion and a humeral head after being implanted. The rotator cuff balloon is provided with a filling cavity, and after the rotator cuff balloon is implanted into the internal tissue of the shoulder joint in a contracted state, the rotator cuff balloon can be expanded into the internal tissue of the shoulder joint by injecting a filling material into the filling cavity of the rotator cuff balloon, and then can be switched to an expanded state. The expansion of the rotator cuff balloon can form a lever effect between the humeral head and the fracture surface of the acromion, thereby preventing the damaged rotator cuff from colliding with the bony structure of the acromion and improving the stability of the glenohumeral joint.

After the rotator cuff balloon is implanted into the internal tissue of the rotator cuff of a patient, the rotator cuff balloon is generally fixed on each tissue in the rotator cuff, for example, the related position of the rotator cuff balloon is matched and fixed on the glenoid, the rotator cuff, the scapula, the humeral head, the deltoid muscle and the like, and the fixation of the rotator cuff balloon at least needs to be simultaneously connected with more than two tissue positions of the listed tissues so as to satisfy that the rotator cuff balloon is integrally and firmly fixed on the internal tissue of the rotator cuff, for example, two ends of the rotator cuff balloon can be respectively fixed on the rotator cuff and the humeral head, or two ends of the rotator cuff balloon can be respectively fixed on the scapula and the deltoid muscle based on the position distribution of each tissue in the rotator cuff, which satisfies the fixation of two ends of the rotator cuff balloon, and enables the rotator cuff balloon to be filled or covered at the position of the original rotator cuff injury, thereby achieving the purpose of rapid treatment.

The research shows that although the rotator cuff balloon is considered to be firmly fixed to enable the rotator cuff balloon to play a stable supporting role in the shoulder joint, the fact proves that the rotator cuff balloon has poor adaptability to the movement of the shoulder joint in the subsequent movement process of the shoulder joint, so that the rotator cuff balloon is continuously rubbed with the bony structure of the humerus to cause the damage of the rotator cuff balloon, and the rotator cuff balloon belongs to an important reason for the reduction of the service life of the rotator cuff balloon. In order to solve the existing technical problems, the rotator cuff balloon can adapt to the movement of the shoulder joint, the service life is prolonged, and the risk of reoperation of a patient is avoided, the utility model provides the following technical scheme.

Referring to fig. 1, one embodiment of the present invention provides a prosthetic shield apparatus 100. The prosthetic shield 100 is adapted to an inflated rotator cuff balloon. As shown in fig. 2, a schematic plan view of the rotator cuff balloon 200 is shown in a state where the protector 100 is used in cooperation with the rotator cuff balloon 200, and the two are formed into a combined rotator cuff prosthesis. In fig. 2, the protector 100 is applied to the outside of the rotator cuff balloon 200, the left half of the drawing shows the protector 100 located at the outside, and the right half shows the rotator cuff balloon 200 located at the inside. For an inflated rotator cuff balloon 200 having an internal fill lumen, inflation refers to filling the interior of rotator cuff balloon 200 with a substance to expand the volume of rotator cuff balloon 200, and rotator cuff balloon 200 may be compressed when not filled with the substance, such as by crimping. The substance may be a liquid such as physiological saline, or the substance may be a gas or a solid. The rotator cuff saccule 200 can be filled with substances after being implanted between the acromion and the humerus, the distance between the acromion and the humerus can be maintained and increased by implanting the rotator cuff saccule 200, so that the torn rotator cuff is directly isolated, the collision between the rotator cuff wound and the bony structure of the acromion is prevented, the pain is relieved, and meanwhile, the force arm of lifting on the shoulder joint is increased by reconstructing the distance between the acromion and the humerus, and the activity capability of the shoulder joint is improved. In the embodiment of the present invention, the specific structure of the rotator cuff balloon 200 is not limited. For example, the rotator cuff balloon 200 may have a single-layer structure, and the rotator cuff balloon 200 may have a multi-layer structure. The rotator cuff balloon 200 may be formed by a blow molding process. Alternatively, the layers may be joined by heat fusion or co-blow molding the layers.

The protector 100 is used to be sleeved outside the rotator cuff balloon 200 and fixed to a predetermined position of a shoulder joint, such as a acromion, humerus, or acromion. The shield 100 may secure the rotator cuff balloon 200 to such an extent that the rotator cuff balloon 200 cannot be released from the restraint of the shield 100. Meanwhile, the rotator cuff balloon 200 has relative movement space inside the protection device 100. Thereby not only ensuring the fixation of the rotator cuff balloon 200, but also avoiding the failure caused by dislocation of the rotator cuff balloon 200; but also can lead the rotator cuff saccule 200 to automatically adapt to the movement of the shoulder joint within the range of the allowed movement, and prolong the service life of the rotator cuff saccule 200. In addition, in the conventional technology, the friction between the rotator cuff balloon 200 and the humerus frequently causes higher requirements on the mechanical properties of the rotator cuff balloon 200. In the embodiment of the present invention, the protection device 100 is equivalent to an outer protection layer of a prosthesis, and increases the overall mechanical properties (puncture, abrasion, and pressure) of the rotator cuff prosthesis, and at the same time, the wear resistance of the prosthesis does not depend on the balloon, so that the requirement on the mechanical properties of the rotator cuff balloon 200 inside is reduced, and the rotator cuff balloon 200 may be made of other materials which do not have good wear resistance, for example, the cost is lower, as long as the material can satisfy the requirement of being full but not having good wear resistance. In addition, for the rotator cuff balloon 200 used as a "lever", the fixation method does not require any structural damage to the rotator cuff balloon 200 itself, and facilitates the preparation thereof.

As shown in Figs. 1 and 2, a shield 100 according to one embodiment of the present invention includes a pouch 10 having an interior 110. The outer surface of the capsular bag 10 has anchors 20 for connection with the acromion or humerus. One side of the pouch 10 has an opening 120 that communicates with the interior 110 of the pouch 10. The size of the bag 10 is matched with the matched shoulder sleeve balloon 200 and is slightly larger than the shoulder sleeve balloon 200. Wherein opening 1201 is sized to allow passage of an adapted rotator cuff balloon 200 in an unfilled, compressed state, but not into or out of lumen 110 through opening 120 when rotator cuff balloon 200 is filled with a substance. Specifically, the substance-filled cross-sectional minimum diameter of rotator cuff balloon 200 is greater than the minimum inner diameter of opening 120, such that rotator cuff balloon 200 cannot enter or exit lumen 110 from opening 120 after being filled with the substance. The minimum diameter of the cross section herein means the diameter of the smallest circumscribed circle of the cross section when the cross section is non-circular. When the shoulder sleeve balloon 200 is used, the shoulder sleeve balloon 200 is in a compressed state and then is placed into the inner cavity 110 of the balloon 10 through the opening 120, then the shoulder sleeve balloon 200 and the protection device 100 are connected and implanted between the acromion and the humerus in the shoulder joint cavity, and then substances are filled into the shoulder sleeve balloon 200, so that the volume of the shoulder sleeve balloon 200 is expanded until the shoulder sleeve balloon 200 cannot enter or exit the inner cavity 110 through the opening 120.

When the rotator cuff balloon 200 is placed in the inner cavity 110 and filled with the substance, the rotator cuff balloon 200 and the bag 10 still have a relative movement space, so that the rotator cuff balloon 200 automatically adapts to the movement of the shoulder joint within the movement range. The upper volume limit of the full material of rotator cuff balloon 200 is set to V1, the volume of lumen 110 is set to V2, and V2 is greater than V1, so that lumen 110 provides space for movement of rotator cuff balloon 200 after the full material of rotator cuff balloon, preferably less than 90% V1/V2. Thus, the pouch 10 acts as a restraint for the rotator cuff balloon 200; meanwhile, the volume ratio range is moderate, so that the rotator cuff balloon 200 is allowed to move in a proper range to automatically adapt to the movement of the shoulder joint. In actual use, the volume V1 can be measured by drainage to measure the amount of the substance to be filled into the rotator cuff balloon 200. When the rotator cuff balloon 200 is inserted into the lumen 110, a substance can be filled into the rotator cuff balloon 200 according to the above measurement results.

As shown in fig. 1, in one example, the bladder 10 is generally flat and approximately circular in shape. As shown in fig. 2, the shape of the rotator cuff balloon 200 conforms to the shape of the pouch 10. As shown in FIG. 1, the size L1 of the opening 120 of the pouch 10 is 0 to 70mm, preferably 15 to 30 mm. The above ranges for L1 may better fit a balloon protective sheath in a delivery system. The bag 10 can be sleeved on the balloon protective sheath, so that the balloon inside the balloon protective sheath enters the bag 10 under the driving of the driving mechanism.

The length of the bag 10 is slightly larger than that of the matched rotator cuff balloon 200, and for example, the length of the rotator cuff balloon 200 is 60mm, the length L3 of the bag 10 is preferably 60-80 mm. The width of the shoulder sleeve balloon 200 is slightly larger than the width of the matched shoulder sleeve balloon 200, and for example, the width of the shoulder sleeve balloon 200 is 60mm, and the width L4 is 60-80 mm. The pouch 10 is not limited to the flattened, approximately circular shape described above, and any shape capable of receiving a fitted rotator cuff balloon 200 may be used to implement embodiments of the present invention.

The pouch 10 may be of an expandable and contractible elastic structure, that is, the pouch 10 has a certain elastic deformation capability, and the volume of the inner cavity 110 is expanded due to the material filling of the rotator cuff balloon 200. That is, the volume of the lumen 110 before the rotator cuff balloon 200 is filled with the substance is smaller than the volume of the lumen 110 after the rotator cuff balloon 200 is filled with the substance. Specifically, when the rotator cuff balloon 200 in the inner cavity 110 is not filled with the substance, the bladder 10 is in the contracted state by the elastic force, and the volume of the inner cavity 110 is small. When rotator cuff balloon 200 is filled with the substance, lumen 110 is expanded and expanded to provide a volume of void V2 greater than the upper volume limit V1 of rotator cuff balloon 200 after filling with the substance, preferably V1/V2 is less than 90%. The pouch 10 is thus able to change shape to automatically adapt to differently shaped rotator cuff prostheses and tissues within the shoulder joint. In particular, the wall of the pouch 10 includes at least one layer of structure. As shown in fig. 2, each layer structure of the capsule wall may be a woven structure formed by weaving a woven wire, or a membrane structure formed by using a thin membrane; or a composite of a woven structure and a membrane structure. Preferably, the capsule wall has a structure with more than two layers. The multilayer film also enhances the puncture resistance of the balloon. The braided structure can also effectively improve the strength of the balloon and enhance the puncture resistance of the balloon.

The outer surface of the pouch 10 may be provided with a curved surface, depression or protrusion for fitting with the acromion or humerus so that the pouch 10 better conforms to the tissues within the acromion. The curved surfaces, depressions or protrusions may be provided on the upper and lower surfaces or the left and right end surfaces of the pouch 10 of fig. 1.

The pouch 10 may also be developable. Since the rotator cuff balloon 200 is placed within the pouch 10, the position of the pouch 10 within the human body may indicate the position of the rotator cuff balloon 200 within the human body. The capsular bag 10 has developing properties, and is favorable for examining the implantation position suitability, the inflated and expanded state and the like of the rotator cuff balloon 200 in the shoulder joint cavity by X-ray in the operation. In the embodiment of the present invention, the outer surface or the capsule wall of the capsule 10 is provided with a developing structure, the developing structure is made of developing materials such as metal, metal oxide or metal salt, and the developing material can be one or more of BaSO4, Bi2O3, (BiO)2CO3, BiOCl, W, WC, Mg, Fe, Nd, Zn and Zr. Particularly, when the pouch 10 is made of biodegradable medical polymer materials, the developing structure is made of one or more of magnesium-based, zinc-based, iron-based and other biodegradable metal materials for biomedical use. Optionally, the developing structure is in the form of a dot, a block or a sheet, and the form of the developing structure is not particularly limited in the present invention. Preferably, the developing structure is plural.

The anchor 20 on the capsular bag 10 may be conveniently attached to the humerus or acromion. Generally, the anchoring elements 20 are fixed to the bony structure of the humeral head, or the like, generally by punching, wrapping, or tying directly to the acromion, forming an integral structure that suspends the prosthesis in the subacromial space, thus effectively fixing the prosthesis in the desired position. The shape of the anchor 20 is not limited, and may be, for example, a band, a wire, a sheet, or another shape.

The capsular bag 10 and the anchoring member 20 are formed by weaving biocompatible ultra-high molecular materials through a fiber weaving process, which provides the capsular bag 10 with excellent mechanical properties such as compression strength, abrasion resistance, suture strength, etc., provides the anchoring member 20 with excellent breaking strength, and provides the capsular bag 10 with excellent connection strength with the anchoring member 20. The biocompatible material can be non-biodegradable material such as polyolefin, polyester, polyamide, polyvinyl chloride, nylon elastomer, polyurethane, rubber, etc., or mixture or composite material of two or more of these materials. Generally, the biodegradable medical polymer material can be selected from biodegradable materials such as polylactic acid, polycaprolactone, polylactide-caprolactone copolymer, polypeptide, polyamino acid, poly-3-hydroxyalkanoate, chitin, PBS, etc., or a mixture or composite material of two or more of these materials. The anchor 20 is formed using a fiber-weaving process, the anchor 20 may be formed from a multi-fiber weave or a single fiber, and the anchor 20 cross-sectional shape includes, but is not limited to, flat, circular, or semi-circular.

The anchor 20 surface may or may not have a coating. In the coated anchor 20, the coating may be comprised of a single or multiple component, single or multilayer structure including, but not limited to, a lubricious layer, or a protective layer to prevent the spread of multiple fibers, or a drug layer to promote wound healing, or a multilayer drug layer structure to control drug release. The lubricating layer can reduce friction between the anchor 20 and the humerus, slow down wear, and prolong the service life of the anchor 20. For example, the lubricious layer may be polyvinylpyrrolidone (PVP), Polytetrafluoroethylene (PTFE), a silicone oil coating, or the like. The protective layer can bind the stranded fibers therein, prevent the stranded fibers from spreading apart, and ensure the strength of the anchor 20. For example, the protective layer may be polyvinylpyrrolidone (PVP), polyacrylamide, or the like. The medicine layer can contact with human tissue and body fluid, thereby promoting wound healing. For example, the drug layer includes at least one of the following drugs: diclofenac diethylamine, fentanyl, and analogs thereof. When a multi-layer medicine layer structure is arranged, the release speed of each medicine layer is different, thereby realizing the periodic release.

The anchor 20 is attached behind the acromion. If the rotator cuff balloon 200 is subjected to a force from a certain position of the joint due to the movement of the shoulder joint, the force is transmitted to the anchoring member 20. The anchor 20 should be able to meet the requirements of repeated pulling. In general, the mechanical properties of the anchor 20 should satisfy the following requirements: the tensile (breaking) capacity is above 100N, i.e. a tensile force of less than 100N does not cause the anchor 20 to break, thereby being able to accommodate the need for a large range of shoulder joint movement. The wear resistance needs to withstand at least 500 ten thousand rubs and the surface roughness needs to be smooth to reduce the wear caused by the friction with the adjacent bony structures. The pouch 10 itself should also have similar mechanical properties. The present invention provides the following embodiments which describe the manner in which the anchor 20 is disposed on the capsular bag 10.

As shown in fig. 1 and 3, in one embodiment, the number of anchors 20 is two, one end of each anchor 20 is connected to the capsular bag 10 and forms a connection point 210, and the portion of each anchor 20 outside the capsular bag 10 forms a free portion 220 for connection to the acromion or humerus. The connection point 210 is to be understood here as a small-scale junction region, the anchoring element 20 being connected to the capsular bag 10 within a relatively limited small scale. Visually, it appears that the junction between the anchor 20 and the capsular bag 10 is dotted rather than linear. The anchor 20 may be fixedly attached to or integrally formed with the pouch 10. For example, when fixedly attached, the anchor 20 may be sutured to the pouch 10 to form a sutured attachment point 210. For integral molding, the anchor 20 may be formed simultaneously with the formation of the pouch 10 by a knitting process. In this embodiment, the capsular bag 10 is used for connection to the acromion and humerus through the two free portions 220 of the anchor 20, respectively, which facilitates the operation of the surgeon and provides more secure fixation of the capsular bag 10. Meanwhile, the rotator cuff balloon 200 receives a force from a certain position of the joint due to the movement of the shoulder joint, the force is dispersedly transmitted to the two anchoring elements 20, and the connection point 210 of each anchoring element 20 and the bag 10 is more reliable, and the bag 10 is not easy to tear or the anchoring elements 20 are not easy to break. In addition, the number of anchors 20 may be more than two. Although the number of the anchoring elements 20 is preferably two or more, it is not intended that a single anchoring element 20 may not be used to directly connect with the capsular bag 10 in a dotted manner and form the free portion 220 as described above. Since the single anchoring element 20 is directly connected to the pouch 10 in a punctiform manner, with the same material and mechanical properties, it simply means that the number of tearing operations under tension may be reduced and it represents an undesirable life span. Those preferred arrangements are more representative of the more likely to be able to withstand the harsher operating environment.

To avoid tearing of the pouch 10 or breaking of the anchor 20 at the connection point 210, the shielding device 100 further comprises a reinforcement 40 connected to said pouch 10, the reinforcement 40 being arranged at the area of fixation of the connection point 210 to the pouch 10. The fastener 40 may be disposed as shown in fig. 8, and may be in the form of a band. The difference is that in fig. 8, the fastening member 40 covers the connection band 230. In this case, the stiffener 40 may be placed around the pouch 10 or around a portion of the pouch 10 and cover the attachment point 210 and the secured area of the pouch 10. In this way, the strength of the anchoring member 40 is improved by protecting the joint between the anchoring member 20 and the pouch 10 while connecting to the pouch 10. The form of securing of the stiffener 40 to the pouch 10 can be accomplished in a variety of ways. For example, the stiffener 40 is secured to the pouch 10 by a braided wire weave. The fastener 40 may also be adhesively secured to the pouch 10. In particular, the fastener 40 may be configured in the form of a protective sleeve that fits over the pouch 10, where it covers at least a portion of the pouch 10 completely, avoiding the opening 120 of the pouch 10 and allowing the free portion 220 of the anchor 20 to pass through.

In other embodiments, the fastener 40 is a heat-fusible layer, and the heat-fusible layer is disposed at the connection point 210 and the fixing region of the pouch 10. The area of the pouch 10 around the attachment point 210, which is integral with the attachment point 210 and pouch 10, acts as a heat-fused area. This also enhances the strength of the junction of the anchor 20 and the capsular bag 10.

In one embodiment, as shown in fig. 4, when two anchors 20 are provided, one each connected to the pouch 10, the two connection points 210 may also be connected by a fastener 40, the fastener 40 being connected to the pouch 10. The fastener 40 may be a securing wire or strap. The two attachment points 210 are also indirectly connected to the capsular bag 10 by the stiffeners 40, thereby indirectly increasing the area of the connection between the two attachment points 210 and the capsular bag 10, and the stiffeners 40 provide some protection to the attachment points 210 and increase the strength of the connection between the anchor 20 and the capsular bag 10.

As shown in FIG. 1, the point of attachment 210 of the anchor 20 to the pouch 10 is offset from the geometric center A of the pouch 10 in order to accommodate the spatial distribution of the human acromion and the size of the bone, to accommodate different populations of different structures in the rotator cuff or different symmetry of the left and right shoulders, and to better conform to the tissues in the rotator cuff. As shown in FIG. 1, the two points of attachment 210 of the anchors 20 to the capsular bag 10 are both offset to the right of the geometric center A of the capsular bag 10. In addition, the connection points 210 of the two anchoring members 20 to the pouch 10 may be symmetrically located at the geometric center a of the pouch 10, so that the traction force applied to the pouch 10 by the two anchoring members 20 is symmetrical to the geometric center of the pouch 10, and the inner cavity 110 is in a stable state, which facilitates the inner cavity 110 to restrain the rotator cuff balloon 200 within a predetermined required activity space.

As shown in fig. 1, the two connection points 210 are spaced apart in the width direction of the pouch 10 and are both located to the right of the geometric center A of the pouch 10. The distance L2 between the two connection points 210 can be 0-70 mm, preferably 5-30 mm. The height of the connection point 210 above the capsular bag 10 is L6. The height of the connection point 210 above the capsular bag 10 refers to the distance from the connection point 210 to the edge of the capsular bag 10. The height L6 is not limited. Preferably, height L6 is half the length L3 of pouch 10. The above ranges for L2 and L6 allow the connection point 210 to be aligned to the anatomy of the human acromion, which in turn allows the pouch 10 to conform to the anatomical configuration. The length L5 of the free portion 220 of the anchor 20 is not particularly limited. However, the free portion 220 is designed to engage the acromion, and the physician needs to manipulate the anchor 20 within the shoulder joint cavity to effect suture fixation, which can be performed in a relatively small space. An excessively long anchor 20 may result in the surgeon operating the instrument during suturing, while the excess thread length after suture securement is long. Therefore, L5 is preferably set to be 100-1000 mm for the convenience of doctor's operation.

The anchor 20 may also be in the form of a single piece connected to the capsular bag 10 with the anchor 20 having two free portions 220. That is, only one anchor 20 is required to achieve connection to the humerus and acromion, respectively. However, it should be noted that a plurality of such anchors 20 may be provided at the same time. The utility model is illustrated by the following specific examples.

In the above embodiments, the fastener 40 is configured to enhance the fixation between the anchor 20 and the pouch 10. In other embodiments, the fastener 40 may also be configured to produce a fixation between the anchor 20 and the capsular bag 10. In other words, the anchor 20 is secured with the pouch 10 by the stiffener 40. For example, the fasteners 40 are in the form of a tape or sheath as described above, and the fasteners 40 secure the anchor 20 to the capsular bag 10 at the same time as the fixation to the capsular bag 10, where the anchor 40 is not itself directly connected to the capsular bag 10. As another example, the fastener 40 is a hot melt layer as described above that establishes a connection between the anchor 40 and the pouch 10.

In one embodiment, as shown in fig. 5, the anchor 20 has a connecting segment 230 that connects to the pouch 10. The connecting segment 230 is secured to the pouch 10. For example, the connecting segments 230 may be secured to the outer surface of the pouch 10. The anchor 20 forms two free portions 220 on either side of the connecting segment 230 that are exposed to the exterior of the pouch 10. Compared to a spot connection, in which the anchor 20 is connected to the capsular bag 10 by the connecting segment 230, the connecting area between the anchor 20 and the capsular bag 10 is large, and thus the strength of the joint is large. There are various forms for the attachment of the connecting segments 230 to the capsular bag 10. For example, the connecting segments 230 may themselves be sewn directly to the pouch 10. Specifically, the partial suturing of the anchor 20 to the pouch 10 using a suture needle forms the connecting segment 230 described above, while two free portions 220 are formed on both sides of the connecting segment 230. As another example, the connecting segments 230 are adhesively secured to the outer surface of the pouch 10. Further, the attachment of the connecting section 230 to the pouch 10 may be provided with a heat fused area that is integral with the attachment point 210 and pouch 10. As another example, the connecting segments 230 may be heat fused directly to the outer surface of the pouch 10.

There may be multiple directions of attachment between the attachment section 230 and the capsular bag 10, which may resist shear forces in different directions, thereby enhancing the strength of the bond between the attachment section 230 and the capsular bag 10. For example, as shown in fig. 5, the connecting segments 230 may be sewn directly to the pouch 10 itself, with the transverse and vertical seams combining to form a criss-cross shape when sewn. However, the shape is not limited thereto, and as shown in fig. 6, the connecting portion 230 may have a curved structure, so that the sewing path is curved when sewing. Alternatively, as shown in fig. 6, the connecting segments 230 may be curved and then bonded or heat-fused to the pouch 10.

The width of connecting segment 230 can be greater than the width of the anchor 20 beyond connecting segment 230. For example, the anchor 20 has a wide middle portion and narrow sides, the middle portion being adapted to be connected to the capsular bag 10. This also increases the area of the connection between the anchor 20 and the capsular bag 10, resulting in a stronger bond between the two.

In one embodiment, as shown in fig. 7, the connecting segment 230 is attached to the outer surface of the pouch 10 via the side of the pouch 10 away from the shoulder, and the length of the connecting segment 230 is greater than the distance between two boundary points 240 between the two free portions 220 and the connecting segment 230. In this manner, the anchor 20 wraps the pouch 10 almost once around the circumference of the pouch 10, and the length of the profile of the wrapped portion of the pouch 10 is greater than the length of the uncoated portion of the pouch 10; and the two free portions 220 are located on the side of the pouch 10 near the acromion for easy connection with the humerus or acromion. Thus, the connecting segments 230 have a larger bonding area with the capsular bag 10, increasing the connection area between the anchor 20 and the capsular bag 10, and thus the strength of the bond therebetween. In addition, the greater length of the connecting segment 230 also facilitates the connection of the connecting segment 230 to the pouch 10.

The above increases the bonding strength between the anchor 20 and the capsular bag 10 by various means. Further, a fastener 40 (see fig. 8) may also be provided on the exterior of the pouch 10 to at least partially cover the connecting segments 230, the fastener 40 being fixedly attached to the pouch 10 to further increase the strength of the bond between the anchor 20 and the pouch 10. The form of securing of the stiffener 40 to the pouch 10 can be accomplished in a variety of ways. For example, the stiffener 40 is secured to the pouch 10 by a braided wire weave. The fastener 40 may also be adhesively secured to the pouch 10. In particular, the fastener 40 may be configured in the form of a protective sleeve, i.e. it covers almost completely the capsular bag 10, avoiding only the opening 120 of the capsular bag 10 and allowing the free portion 220 of the anchor 20 to pass through.

As shown in fig. 8, the connecting segment 230 may also be inserted into the pouch 10. In particular, one end of the anchor 20 is threaded into the capsular bag 10 at one location on the outer surface of the capsular bag 10 and then threaded out of the capsular bag 10 at another location on the outer surface of the capsular bag, with the portion of the anchor 20 between the two locations being the connecting segment 230. In this case, the connecting portion 230 can be fixed to the pouch 10 by the fastener 40, so that the bonding area between the anchor 20 and the pouch 10 is large and the bonding strength is high. The setting of the firmware 40 is the same as the previous embodiment, and will not be described again. In addition, the connecting segments 230 are pierced through the pouch 10, and even if the fastener 40 fails, the anchor 20 does not fail, thereby providing better reliability.

The protection device 100 provided by the embodiment of the utility model is used for fixing the rotator cuff balloon 200, preventing the rotator cuff balloon 200 from dislocating, enhancing the bone puncture resistance, the abrasion resistance and the pressure bearing capacity of the rotator cuff balloon 200, prolonging the service life of the rotator cuff balloon and continuously improving the shoulder joint mobility. Meanwhile, the protective device 100 and the rotator cuff balloon 200 isolate damaged rotator cuff tissues together, prevent the acromion from impacting the rotator cuff tearing wound and the bone tissues in the acromion, thereby relieving the pain of the patient, simultaneously improve the activity of the shoulder joint immediately by reconstructing the distance between the humeral head and the acromion, help the patient to perform rehabilitation training in the early stage, and reduce the occurrence of adverse events such as foreign body sensation, prosthesis dislocation, functional failure and the like of the patient.

The utility model also provides a combined prosthesis, which is shown in fig. 2 and comprises the protection device 100 and the rotator cuff balloon 200. The rotator cuff balloon 200 enters the lumen 110 from the opening 120 after being compressed. After the combined rotator cuff prosthesis is implanted in the shoulder joint cavity, the rotator cuff balloon 200 is inflated by the filling of the substance and is held in the balloon 10. The anchors 20 of the capsular bag 10 of the protector 100 are connected to the humerus or acromion to form an integral structure that suspends the prosthesis in the subacromial space, thereby effectively securing the prosthesis in the desired position.

The technical features of the above embodiments can be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the above embodiments are not described, but should be considered as the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above examples only show some embodiments of the present invention, and the description thereof is more specific and detailed, but not to be construed as limiting the scope of the utility model. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (14)

1. A prosthetic shield device, comprising:

the balloon is provided with an inner cavity and an opening communicated with the inner cavity to form an expandable and contractible structure, and the inner cavity is used for accommodating the inflated rotator cuff balloon;

an anchor connected to the pouch, the anchor having at least one free portion;

a stiffener configured to create or enhance a fixation between the anchor and the capsular bag.

2. The prosthetic shield apparatus of claim 1 wherein the anchor is connected to the capsular bag by a connection point, the fastener being disposed at a fixed region of the connection point and the capsular bag.

3. The prosthetic shield of claim 2 wherein the strength member is disposed around the bladder; alternatively, the stiffener is sleeved over the bladder to cover at least a portion of the bladder.

4. The prosthetic shield of claim 2 wherein the fastener is woven into engagement with the outer surface of the bladder.

5. The prosthetic shield of claim 1 wherein the anchor is in braided fixation with the capsular bag; alternatively, the anchor is integrally formed with the pouch by a knitting process.

6. The prosthetic shield of claim 2 wherein the fastener is a heat fusible layer disposed between the attachment point and the fixation area of the pouch.

7. The prosthetic shield apparatus of claim 2 wherein the connection points include two of the connection points and the two connection points are formed between two of the anchors and the capsular bag, the anchors each having the free portion; the two connecting points are connected through a reinforcing piece, and the reinforcing piece is connected with the bag.

8. A prosthetic shield device, comprising:

the balloon is provided with an inner cavity and an opening communicated with the inner cavity to form an expandable and contractible structure, and the inner cavity is used for accommodating the inflated rotator cuff balloon;

an anchor connected to the pouch by a connecting segment, the anchor having at least one free portion.

9. The prosthetic shield of claim 8 wherein the connecting segment is connected to the capsular bag in at least two directions.

10. The prosthetic shield of claim 8 wherein the connecting segment has a width greater than a width of the anchor at portions of the anchor beyond the connecting segment.

11. The prosthetic shield of claim 8 wherein the connecting segment is a localized location on the anchor and the anchor has two free portions formed on each side of the connecting segment that are exposed to the exterior of the capsular bag.

12. The prosthetic shield of claim 11 wherein the connecting segment is attached to the outer surface of the bladder on a side of the bladder remote from the acromion and the connecting segment has a length greater than the separation of the demarcation point between the free portions and the connecting segment; or the connecting section is arranged in the bag in a penetrating way.

13. The prosthetic shield of claim 8 further comprising a reinforcement between the attachment section and the capsular bag, the reinforcement for reinforcing the attachment section and the capsular bag.

14. A composite prosthesis, comprising:

the prosthetic shield of any one of claims 1-13;

the inflatable rotator cuff balloon can be movably contained in the inner cavity after being inflated by substances but cannot exit the inner cavity through the opening.

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