Rotator Cuff Balloon

Abstract

This invention discloses a rotator cuff balloon. The rotator cuff balloon includes a restraining structure and a protective structure connected to the restraining structure; the restraining structure has an arc along the coronal plane. This prosthesis conforms to the physiological structure of the human shoulder joint, self-confining within the subacromial space, and can reduce adverse events such as foreign body sensation, dislocation, and functional failure in patients.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to a rotator cuff balloon. Background Art

[0002] The rotator cuff is a muscle-tendon structure connecting the scapula and the humeral head. It is located in the outer layer of the shoulder joint capsule and the inner layer of the deltoid muscle. The rotator cuff is composed of the anterior rotator cuff (subscapularis), the superior rotator cuff (supraspinatus), and the posterior rotator cuff (infraspinatus and teres minor). In addition to the functions of internal rotation, external rotation, and abduction of the upper arm, the rotator cuff is mainly used to stabilize the position of the humeral head on the glenoid cavity and prevent the humeral head from moving upward and hitting the acromion, causing pain. Therefore, the rotator cuff plays an extremely important role in maintaining the stability of the shoulder joint and the process of shoulder joint movement. However, with the increase of age, long-term and repeated shoulder joint activities, subacromial bone hyperplasia, or repeated and intense activities may cause wear and tear of the subacromial soft tissue (joint bursa, rotator cuff), which impairs the stability and mobility of the humeral head. During the shoulder joint movement, the patient's arm cannot be abducted or raised, and the collision between bones or between bones and the rotator cuff brings severe pain. The patient cannot sleep at night, which seriously affects the quality of life and self-care ability.

[0003] At present, the treatment methods for rotator cuff injuries mainly include surgical treatment and prosthesis implantation. For mild rotator cuff injuries, surgical treatment can achieve better results, but for injuries greater than 3 cm, the effect of surgical treatment is unclear and easy to recur. Prosthesis implantation artificially limits the upward movement of the humeral head to avoid pain caused by inter-tissue collision, and also increases the force arm of the deltoid muscle, so as to immediately improve the patient's shoulder joint function. Prosthesis implants in the prior art, such as prosthetic devices and biological gaskets, may be displaced during patient activities. For example, the displacement of the prosthetic device may cause changes in pressure distribution, causing the prosthesis to rupture, and the deteriorated contents that have been at 37° for a long time will be released, causing further damage to the affected part, and the injection hole has a hard material. After implantation, it may cause discomfort and foreign body sensation in patients under specific actions. The displacement of the biological gasket may cause discomfort, activity restriction, and even damage to the surrounding soft tissues in patients, causing further injury. In addition, the prosthetic implants in the prior art may fail. Summary of the invention

[0004] Based on this, it is necessary to provide a rotator cuff balloon that conforms to the physiological structure of the human shoulder joint and is self-limited to the subacromial space to solve the problem of implant displacement and reduce the occurrence of adverse events.

[0005] In order to achieve the above-mentioned invention object, the present invention discloses a rotator cuff balloon, characterized in that it includes: a balloon body, the balloon body includes a restriction structure and a protective structure connected to the restriction structure, the maximum width of the restriction structure is greater than the maximum width of the protective structure, the protective structure includes an arc segment, and the curvature of the arc segment is ≤0.21mm -1 The limiting structure includes a first surface and a second surface, the curvature radius of the second surface is 10-50mm; a balloon interface, which is arranged at the opening of the balloon body for allowing the filler to pass through and enter the balloon body; a sealing component, which is arranged at the balloon body and / or the balloon interface and includes a sealing body; an outer catheter, which is detachably connected to the balloon interface, and the filler enters the opening of the balloon body through the outer catheter.

[0006] Furthermore, the thickness H1 of the protection structure is 4-20 mm, and the straight length H2 of the limiting structure along the sagittal plane is H1+15 mm.

[0007] Furthermore, the protection structure includes an arc segment, and a line connecting two end points of the arc segment and a maximum width of the limiting structure forms an isosceles trapezoid.

[0008] Furthermore, the balloon body includes at least two layers of structure, and the materials of the two layers of structure are the same or different.

[0009] Furthermore, the balloon body includes an inner layer, an outer layer and a drug layer located between the inner layer and the outer layer.

[0010] Furthermore, the outer layer is composed of a degradable polymer material, and / or the drug layer includes at least one of the following drugs: diclofenac diethylamide, fentanyl and its analogs, etorphine and its analogs, α2 receptor agonist medetomidine, droperidol, etorphine, vecuronium bromide and its analogs, procaine hydrochloride, tetracaine hydrochloride, lidocaine hydrochloride, antibiotics, and cephalosporin anti-inflammatory drugs.

[0011] Furthermore, the present invention also discloses a rotator cuff balloon, comprising: a balloon body, a balloon interface and a sealing component, the balloon body comprising at least two layers, both of which are composed of polyethylene, the balloon body comprising a restriction structure and a protective structure connected to the restriction structure, the maximum width of the restriction structure is greater than the maximum width of the protective structure, the protective structure comprises an arc segment, and the curvature of the arc segment is ≤0.21 mm -1 The limiting structure includes a first surface and a second surface, the curvature radius of the second surface is 10-50 mm. The thickness H1 of the protection structure is 4-20 mm.

[0012] Furthermore, the sealing assembly is arranged at the balloon body and / or the balloon interface, including a sealing body, which includes a sealing membrane that prevents the filling from flowing out of the balloon body, and an outer catheter that is detachably connected to the balloon interface, and the filling enters the opening of the balloon body through the outer catheter.

[0013] Furthermore, the sealing body is arranged in the balloon body, and the sealing assembly includes an auxiliary tube detachably connected to the sealing body for pre-positioning the sealing body at the opening of the balloon body.

[0014] Furthermore, the protection structure includes an arc segment, and a line connecting two end points of the arc segment and a maximum width of the limiting structure forms an isosceles trapezoid.

[0015] The rotator cuff balloon provided by the present invention conforms to the physiological structure of the human shoulder joint, is self-limited to the subacromial space, and can reduce the occurrence of adverse events such as foreign body sensation, dislocation, and functional failure in patients. Among them, the protective structure is used to support the gap between the humeral head and the acromion of the human shoulder joint to achieve the supporting function. At the same time, the humeral head of the patient with rotator cuff injury moves upward, avoiding the pain caused by the collision between tissues, and further increasing the force arm of the deltoid muscle, so as to immediately improve the patient's shoulder joint function. The limiting structure is used to fit at least partially with the humeral head of the human shoulder joint to play a limiting role and avoid displacement of the prosthesis.

[0016] The first and second surfaces of the limiting structure of the rotator cuff balloon provided by the present invention are both curved surfaces, so that the limiting structure can fully or partially fit the humeral head or greater tuberosity of the human body, thereby enabling the limiting structure to play a maximum limiting role and avoid prosthesis displacement to the greatest extent.

[0017] The edge of the limiting structure of the rotator cuff balloon provided by the present invention is arc-shaped, and this arc-shaped structure can adapt to the physiological shape of the shoulder joint and the top of the rotator cuff, will not restrict the patient's activities, and will not damage the surrounding soft tissues.

[0018] The limiting structure of the rotator cuff balloon provided by the present invention has a first accommodating cavity, and the protective structure has a second accommodating cavity communicated with the first accommodating cavity. After the filler is injected into the limiting structure and the protective structure, the protective structure can fit the rotator cuff, avoid the collision of the rotator cuff with the acromion or other tissue structures during the movement of the shoulder joint, and can maintain the distance between the humeral head and the acromion, maintain the length of the shoulder joint active force arm, and reduce muscle load; the limiting structure can be tightly engaged with the humeral head of the human shoulder joint to improve the limiting ability. Filling liquid and colloid can be injected into the limiting structure and the protective structure to achieve the purpose of fitting with the physiological structure of the joint, which can well improve the shoulder joint function of patients with rotator cuff injuries, and the special shape of the prosthesis adapts to the special physiological structure of the human shoulder joint, so as to achieve better support and reduce collision, and obtain better treatment effects.

[0019] The rotator cuff balloon provided by the present invention is designed to reduce the possible foreign body sensation caused to the patient after the implantation of the prosthesis. When the first accommodating cavity and the second accommodating cavity are filled with fillers, the thickness of the limiting structure gradually increases from the end far away from the protective structure to the end connected to the protective structure. That is, the limiting structure is designed to be thinner on the outside and gradually thicker toward the proximal end, thereby reducing the impact of the limiting structure on the humeral head during activity.

[0020] The rotator cuff balloon provided by the present invention can effectively achieve the sealing of the balloon body, prevent the filling liquid or gel from flowing out of the balloon, and has a simple structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 Schematic diagram of the anatomical planes of the human body;

[0022] Figure 2 A schematic side cross-sectional view of a rotator cuff balloon according to an embodiment of the present invention;

[0023] Figure 3 for Figure 1 A schematic diagram of the rotator cuff balloon viewed from above is shown;

[0024] Figure 4 for Figure 1 A schematic diagram of the posterior view of the rotator cuff balloon is shown;

[0025] Figure 5 for Figure 1 A frontal view of the rotator cuff balloon is shown;

[0026] Figure 6 for Figure 1 A side view of the rotator cuff balloon is shown;

[0027] Figure 7 for Figure 1 The diagram of the coordination between the rotator cuff balloon and the human body is shown;

[0028] Figure 8 : is a side view of a rotator cuff balloon of another embodiment; wherein L1 is the length of the rotator cuff balloon along the coronal plane, L2 is the length of the protective structure in the rotator cuff balloon along the coronal plane, H1 is the height of the protective structure in the rotator cuff balloon along the sagittal plane, and H2 is the height of the rotator cuff balloon along the sagittal plane;

[0029] Fig. 9 Schematic diagram of a top view of a rotator cuff balloon of another embodiment; wherein L3 is the width of the protection structure in the rotator cuff balloon along the horizontal plane, and L4 is the width of the restriction structure in the rotator cuff balloon along the horizontal plane;

[0030] Fig.10 A schematic top view of a rotator cuff balloon according to another embodiment;

[0031] Fig.11A schematic top view of a rotator cuff balloon according to another embodiment;

[0032] Fig.12 Schematic diagram of the sealing structure of a rotator cuff balloon according to another embodiment.

[0033] Description of Reference Numerals

[0034] 10: rotator cuff balloon; 100: restriction structure; 110: first accommodating chamber; 200: protection structure; 210: second accommodating chamber; 300: injection hole; 400: injection tube; 500: one-way valve; 600: filler. DETAILED DESCRIPTION

[0035] In order to facilitate the understanding of the present invention, the present invention will be described more fully below with reference to the relevant drawings. The preferred embodiments of the present invention are given in the drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present invention more thorough and comprehensive.

[0036] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art of the present invention. The terms used herein in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. The term "and / or" used herein includes any and all combinations of one or more related listed items.

[0037] See also Figure 1 As shown, Figure 1 It is a schematic diagram defining various anatomical planes of the human body. Among them, the sagittal plane 101 refers to a longitudinal section that divides the human body or joint into left and right parts from the front-back direction, wherein the sagittal plane passing through the middle of the human body is the median sagittal plane, which divides the human body into two equal left and right parts; the coronal plane 102 refers to a longitudinal section that divides the human body or joint into front and back parts from the left-right direction, and this section is perpendicular to the sagittal plane; the horizontal plane 103 is also called a transverse plane, which is a plane parallel to the ground plane that divides the human body or joint into upper and lower parts, and this plane is perpendicular to the coronal plane and the sagittal plane.

[0038] See also Figure 2As shown, an embodiment of the present invention provides a rotator cuff balloon 10, which includes a restriction structure 100 and a protective structure 200 connected to the restriction structure 100. The restriction structure 100 has an arc along the coronal plane, or the restriction structure 100 and the protective structure 200 have an angle along the coronal plane. Preferably, the restriction structure 100 has an arc along both the coronal plane and the sagittal plane, and the radius of curvature of the inner surface of the restriction structure 100 is 10 to 50 mm. Specifically, the restriction structure 100 has a first surface and a second surface, and the first surface and the second surface of the restriction structure 100 are both curved surfaces. For example, the second surface is an inner surface (such as Figure 2 surface facing downwards as shown). See Figure 7 As shown, the second surface is used to fit the humeral head and / or the greater tuberosity in whole or in part, and the second surface extends from the humeral head to at least partially cover the greater tuberosity. The inventors found that compared with covering only the humeral head, the second surface of the limiting structure 100 partially or completely covers the greater tuberosity to avoid the displacement and detachment of the prosthesis when the arm is abducted and internally rotated, and at the same time, the wound of the rotator cuff tendon tear can be protected on the inner side of the prosthesis limiting structure, further avoiding the severe pain of the patient caused by the collision of the tear wound and the bone. Therefore, the limiting structure 100 can play the best limiting role and avoid the displacement of the rotator cuff balloon to the greatest extent. Preferably, the limiting structure 100 can be a semi-bowl-shaped structure, and the limiting structure 100 of the semi-bowl-shaped structure can fit the humeral head and play the function of maintaining the position of the entire rotator cuff balloon. It can be understood that in other embodiments, the structure and shape of the limiting structure 100 are not limited to the above, and the structure and shape of the limiting structure 100 can also be a semi-basin-shaped, semi-bowl-shaped structure, etc.

[0039] See also Figure 7 As shown, the protection structure 20 is used to support the acromion in the gap between the humeral head and the acromion of the human shoulder joint to support the acromion.

[0040] Further, see Figure 4 and Figure 5 As shown, the edge of the limiting structure 100 is arc-shaped and smooth. This arc-shaped structure can adapt to the physiological shape of the shoulder joint and the top of the rotator cuff, reducing the damage to the muscle tissue caused by the outer edge of the limiting structure 100 when the shoulder joint moves.

[0041] Further, see Figure 2 and Figure 3 As shown, the maximum width of the limiting structure 100 is greater than the maximum width of the protective structure 200. Figure 8As shown, the width L4 at the transition position between the limiting structure 100 and the protective structure 200 is greater than the width L3 of the protective structure 200. This arrangement can improve the fit of the limiting structure 100 with the humeral head and greater tuberosity of the human shoulder joint, and cooperate with the subacromial bursa fold to limit the displacement of the protective structure 200 and the entire rotator cuff balloon. Preferably, the limiting structure 100 and / or the protective structure 200 can be deformed, and the deformation can be a restorative deformation after compression, an expansive deformation after being filled with a filler, or other forms of deformation. The limiting structure 100 and / or the protective structure 200 can be deformed to achieve cooperation with the humeral head of the human shoulder joint, the gap between the humeral head of the human shoulder joint and the acromion, adapt to the special physiological structure of the human shoulder joint, achieve better support, reduce impact, and obtain better treatment effects. During the filling process, the limiting structure 100 and / or the protective structure 200 adapt to the physiological structure of the shoulder joint through deformation, such as self-expansion after compression or expansion after filling, and can fit the human humeral head. At the same time, in conjunction with the physiological structure of the shoulder joint synovial fold reflection, it can limit the medial and lateral displacement of the rotator cuff balloon on the shoulder joint, and limit itself to the subacromial space to avoid dislocation. In addition, the adaptive function brought about by the deformation ensures that the limiting structure 100 and the protective structure 200 will not restrict the patient's activities or damage the surrounding soft tissues.

[0042] In another embodiment, see Figure 8 As shown, H1 is the height of the protective structure 200 in the rotator cuff balloon 10 along the sagittal plane, that is, the thickness of the protective structure 200, which is preferably 4-20 mm. According to the elastic mechanics principle of a closed cavity under pressure, P = σ·h / r, where P is the maximum pressure that the cavity can withstand, σ is the circumferential stress strength of the cavity shell material, h is the wall thickness of the cavity shell, and r is the minimum radius of the cavity. At the subacromial space position where the shoulder joint prosthesis of the present invention is implanted, the maximum pressure of mutual compression between the acromion and the humeral head is about 88KPa (i.e., P=88KPa), and the height H1 of the shoulder joint prosthesis protection structure is 4-20mm (i.e., the radius of the protection structure cavity at the minimum r=2-10mm), then the value range of σ·h is 176-880KPa·mm, and the significance of this value is to guide the selection of the shoulder joint prosthesis material and the specific design of the wall thickness. For example, when the shoulder joint prosthesis wall thickness h is 0.1mm, at least the material with the prosthesis material strength σ in the range of 1760-8800KPa can be selected. In fact, commonly used non-degradable and degradable medical materials such as polyamide, polyester, polyethylene, polylactic acid, polycaprolactone, etc. can meet this requirement. Therefore, H1 is preferably 4-20mm, which can realize the function of the protection structure supporting the humeral head and the acromion under the conditions of commonly used medical materials and conventional manufacturing accuracy.

[0043] H2 is the height of the rotator cuff balloon 10 along the sagittal plane, which is preferably 9-34 mm. More preferably, the linear length H2 of the restriction structure 100 along the sagittal plane is H1+15 mm, which can achieve the restriction structure 100 covering the greater tubercle of the humeral head and avoid hindering the activity of the rotator cuff muscle group due to the restriction structure 100 being too large.

[0044] See also Figure 8 As shown in FIG. 8 , L1 is the length of the rotator cuff balloon 10 along the coronal plane, which is preferably 30-70 mm. L2 is the length of the protective structure 200 in the rotator cuff balloon 10 along the coronal plane, which is preferably 10-40 mm. Referring to FIG. 8 , L3 is the width of the protective structure 200 in the rotator cuff balloon 10 along the horizontal plane, which is preferably 15-60 mm. L4 is the width of the limiting structure 100 in the rotator cuff balloon 10 along the horizontal plane, which is preferably 20-70 mm. The above arrangement can achieve the effect of the protective structure 200 separating the acromion and the humeral head, and the limiting structure 100 covering the humeral head and the greater tuberosity to prevent dislocation.

[0045] The above-mentioned rotator cuff balloons 10 of different sizes are suitable for humeral heads of different diameters. For example, when the humeral head has a diameter of 5 cm, preferably H1 is 10-12 mm, H2 is 25-27 mm, L1 is 55-65 mm, L2 is 25-35 mm, L3 is 30-50 mm, L4 is 55-60 mm, and the curvature radius of the inner surface of the limiting structure 100 is 25-30 mm.

[0046] See also Figure 8 As shown, the thickness of the limiting structure 100 gradually increases from an end away from the protection structure 200 to an end connected to the protection structure 200 .

[0047] Fig. 9 FIG. 2 is a top view of another embodiment of the shoulder joint prosthesis. Fig. 9 As shown, the line connecting the maximum widths of the limiting structure 100 constitutes point D and point C, and the protective structure 200 includes an arc segment, and the endpoints of the arc segment constitute point A and point B. The points A, B, C, and D constitute an isosceles trapezoid, which can enhance the transmission of horizontal force between the AB side and the CD side of the protective structure. When the arm is abducted and raised, the humeral head rotates toward the inside of the shoulder joint socket, forming a horizontal force from CD to AB on the protective structure, causing horizontal extrusion between the protective structures. The design of a large-angle trapezoidal profile reduces the loss of force transmitted between the edges on both sides, thereby reducing the internal strain of the protective structure during the dynamic process of arm abduction, resulting in deformation and wrinkling. More preferably, the curvature of the arc segment AB is preferably ≤0.21mm -1 The curvature of the CD segment is preferably ≤0.15mm -1 .

[0048] Point A and point D can be connected by one or more straight line segments, one or more arc segments, or a straight line segment and an arc segment. Fig.10 As shown, between point A and point B, there are arc segments AB and BC, wherein the arc curvature of segment AB and segment EF is preferably ≤0.3mm -1 The curvature of the arc between the BC and DE segments is preferably ≤0.15mm -1 .

[0049] The limiting structure 100 has a first accommodating cavity 110, and the protective structure 200 has a second accommodating cavity 210 communicating with the first accommodating cavity 110. Both the first accommodating cavity 110 and the second accommodating cavity 210 are used to be filled with a filler 600. During the filling process, after the limiting structure 100 and the protective structure 200 are filled with the filler 600, the protective structure 200 can fit the rotator cuff, prevent the rotator cuff from colliding with the acromion or other tissue structures during the movement of the shoulder joint, and can maintain the distance between the humeral head and the acromion, maintain the length of the shoulder joint activity arm, and reduce muscle load; the limiting structure 100 can be tightly engaged with the humeral head of the human shoulder joint to improve the limiting ability.

[0050] Preferably, the limiting structure 100 and the protecting structure 200 may be balloons, sponge-like elements, or non-expandable structures.

[0051] When the limiting structure 100 has the first accommodating cavity 110 and the protective structure 200 has the second accommodating cavity 210, the maximum thickness of the limiting structure 100 gradually increases from the end away from the protective structure 200 to the end connected to the protective structure 200. The minimum thickness of the limiting structure 100 is the thickness before filling the filler or the thickness after the limiting structure 100 is compressed; the maximum thickness of the limiting structure 100 is the thickness after filling the filler or the thickness of the limiting structure 100 in the self-recovery state after compression. The minimum thickness of the protective structure 200 is the thickness before filling the filler or the thickness after the protective structure 200 is compressed; the maximum thickness of the protective structure 200 is the thickness after filling the filler or the thickness of the protective structure 200 in the self-recovery state after compression.

[0052] See also Figure 2As shown, when the first accommodating cavity 110 and the second accommodating cavity 210 are both filled with fillers 600, the thickness of the limiting structure 100 gradually increases from the end away from the protective structure 200 to the end connected to the protective structure 200. In order to reduce the possible foreign body sensation caused to the patient after the rotator cuff balloon 10 is implanted, it is set that when the first accommodating cavity 110 and the second accommodating cavity 210 are both filled with fillers 600, the thickness of the limiting structure 100 gradually increases from the end away from the protective structure 200 to the end connected to the protective structure 200, that is, the limiting structure 100 is designed to be thinner on the outside and gradually thicker toward the proximal end, so as to reduce the influence of the limiting structure 100 on the humeral head during activities.

[0053] In addition, the capsule wall of the protection structure 200 can be specifically optimized according to different usage requirements. For example, for those with more sports needs, the thickness can be appropriately increased to increase the service life.

[0054] Furthermore, when the first accommodating cavity 110 and the second accommodating cavity 210 are both filled with the filler 600, the thickness of the end where the limiting structure 100 is connected to the protective structure 200 is consistent with the thickness of the protective structure 200 to reduce discomfort of the humeral head during shoulder joint movement.

[0055] One of the surfaces of the protective structure 200 is curved so that the surface is basically in contact with the rotator cuff. Specifically, the protective structure 200 is an arc-shaped structure that bends downward on the horizontal axis plane. This arc-shaped structure is adapted to the physiological shape of the shoulder joint and the top of the rotator cuff. After the filler 600 is injected, the protective structure 200 can fit the rotator cuff and prevent the rotator cuff from colliding with the acromion or other tissue structures during the movement of the shoulder joint. It can also maintain the distance between the humeral head and the acromion, maintain the length of the shoulder joint activity arm, and reduce muscle load.

[0056] Further, see Figure 3 and Figure 5 As shown, an injection hole 300 is provided on the limiting structure 100 and / or the protective structure 200, and the injection hole 300 is connected to the first accommodating chamber 110 and the second accommodating chamber 210. A one-way valve 500 is provided in the injection hole 300, and the one-way valve 500 can prevent the filler 600 injected through the injection hole 300 from flowing out in reverse.

[0057] Further, see Figure 2 and Figure 6 As shown, the above-mentioned rotator cuff balloon 10 also includes an injection tube 400 arranged in the first accommodating cavity 110 and / or the second accommodating cavity 210 and connected to the injection hole 300, the outward tube mouth of the injection tube 400 is flush with the outer surface of the limiting structure 100 or the protective structure 200, and the one-way valve 500 is arranged in the injection tube 400.

[0058] Further, see Figure 6As shown, the diameter of the end of the injection pipe 400 connected to the injection hole 300 is smaller than that of the inward end thereof.

[0059] Preferably, the injection tube 400 is flexible, which effectively solves the problem in the conventional technology that certain actions after implantation may cause discomfort and foreign body sensation to the patient.

[0060] Further, see Figure 6 As shown, the limiting structure 100 and the protective structure 200 are connected to form an integrated structure. The design of the integrated structure of the limiting structure 100 and the protective structure 200 is convenient for mold opening and processing, and has a low production cost.

[0061] Furthermore, the limiting structure 100, the protective structure 200 and the injection tube 400 are all made of non-degradable materials. The limiting structure 100 and the protective structure 200 of the rotator cuff balloon 10 of the present invention are all made of non-degradable materials, which solves the problem of short-term degradation failure of the implant in the conventional technology, avoids the rupture of the rotator cuff balloon 10, enables it to work effectively for a long time at a temperature of 37°, and effectively prevents the release of the deteriorated filler from causing further damage to the affected part.

[0062] Furthermore, the materials for preparing the limiting structure 100 include, but are not limited to, one or more of silicone, polyurethane, rubber, polyamide, polyester, and polyolefin. The materials for preparing the protective structure 200 include, but are not limited to, one or more of silicone, polyurethane, rubber, polyamide, polyester, and polyolefin. The materials for preparing the injection tube 400 include, but are not limited to, one or more of silicone, polyurethane, rubber, polyamide, polyester, and polyolefin. In a preferred embodiment, in order for the rotator cuff balloon to provide long-term support for the acromion, the balloon is preferably made of a double-layer balloon, and the material of the double-layer balloon is polyethylene. The inventors have found that the balloon placed in the shoulder joint cavity needs to face the problems of bone spurs and moderate flexibility at the same time. The double-layer polyethylene rotator cuff balloon can effectively improve the puncture resistance and can effectively fill the human joint cavity after the balloon is filled to achieve self-adaptation.

[0063] Further, see Figure 2 As shown, the rotator cuff balloon 10 further includes a filler 600, and the filler 600 is filled in the first accommodation chamber 110 and the second accommodation chamber 210. Preferably, the filler 600 includes liquid and / or colloid. For example, the filler 600 is water, silica gel, gel, etc.

[0064] Fig.11The figure shows a cross-sectional schematic diagram of the sealing assembly of the rotator cuff balloon disclosed in the application, wherein the sealing assembly includes a sealing body 9 built into the balloon body 7 and an auxiliary tube 11 detachably connected to the sealing body 9, and the sealing body 9 can be positioned and covered on the balloon interface 8 through the auxiliary tube 11. Before the filling begins, the auxiliary tube 11 is pre-connected to the sealing body 9, and then the outer catheter 10 is connected to the balloon interface 8. At the beginning of the filling, the auxiliary tube 11 is pushed to push the sealing body 9 to open the cavity of the balloon body 7, and the filling of the balloon body 7 is achieved through the annular gap between the outer catheter 10 and the auxiliary tube 11. After the filling is completed, the sealing body 9 is pressed against the opening by the pressure inside the balloon body 7. At this time, the outer catheter 10 and the auxiliary tube 11 are removed and withdrawn from the body, and the sealing of the balloon body 7 can be achieved at the same time. The auxiliary tube 11 or the sealing body 9 may be designed with a weak area 12. When the operator applies pressure to the auxiliary tube 11, the sealing body 9 is pressed against the opening of the balloon body 7 by the pressure inside the balloon body 7, and the weak area 12 breaks. In another optional solution, a mutually matching thread may be provided between one end of the sealing body 9 and the auxiliary tube 11, or one end of the sealing body 9 may be interference fit with the auxiliary tube 11.

[0065] The present invention provides an implant prosthesis, which includes at least two layers, wherein the inner layer is a sealed structure, and the drug layer is located on the entire or partial surface of the inner layer. The inner layer can be filled with liquid or semi-solid. The implant prosthesis may also include an outer layer, wherein the drug layer is located between the inner layer and the outer layer, and the drug layer may be a liquid drug or a solid drug. The outer layer may be a degradable material or a porous material.

[0066] In a preferred embodiment, the surface or interior of the rotator cuff balloon provided by the present invention can be loaded with drugs.

[0067] In a preferred embodiment, the drug-loaded rotator cuff balloon can achieve instant drug release. After the rotator cuff balloon is implanted in the human body and expanded, the outer surface of the balloon contacts human tissue and body fluid, thereby instantly releasing the drug on the outer surface of the balloon. The drug coating can be loaded on the outer surface of the balloon by elution. Furthermore, prefabricated grooves can be formed on the outer surface of the balloon to increase the drug loading amount. The balloon surface can be loaded with drugs that promote the recovery of damaged tendons or relieve pain, analgesia, or anti-inflammatory effects, so as to promote the growth and recovery of torn tendons or relieve patient pain or eliminate inflammation.

[0068] The balloon can be eluted, or the outer layer of the balloon wall can be provided with grooves to load drugs.

[0069] The drug loaded in the balloon can be selected from one or more combinations of diclofenac diethylamide, fentanyl and its analogs, etorphine and its analogs, α2 receptor agonist medetomidine, droperidol, etorphine, vecuronium bromide and its analogs, procaine hydrochloride, tetracaine hydrochloride, lidocaine hydrochloride, antibiotics, cephalosporin anti-inflammatory drugs and other drugs that have the effects of promoting tendon repair or relieving pain or eliminating inflammation.

[0070] The balloon can be filled and expanded with gas, liquid or gel, and the filling composition can be determined according to the doctor's needs.

[0071] The balloon filling material can be selected from drug solution or gel, and the balloon material can be selected from biodegradable medical polymer materials. When the balloon is degraded, the medicine inside the balloon can be released to the lesion site.

[0072] In a preferred embodiment, the drug-loaded rotator cuff balloon can achieve timed drug release. The rotator cuff balloon is a double-layer two-chamber balloon structure, the outer cavity is used to store drugs, and the inner cavity is used to fill and expand the balloon. The outer layer material of the balloon is selected from biodegradable medical polymer materials. When the outer layer of the balloon wall degrades, the outer cavity drug of the double-layer two-chamber structure balloon will come into contact with human tissue and body fluids, thereby releasing the drug to play a therapeutic role. The degradation time of the outer layer of the balloon can be quantitatively controlled by adjusting the polymer composition, polymer segment structure, molecular weight, crystallinity, and wall thickness of the outer layer material of the balloon. When the balloon implantation time reaches the clinical demand time, the outer layer of the balloon wall completes degradation, releases the drug, and forms a time-fixed release. The inner layer material of the balloon can be selected from degradable biomedical polymer materials, or non-degradable medical polymer materials.

[0073] The balloon can be filled with gas, liquid or gel to expand the inner cavity, and the filling composition can be determined according to the doctor's needs. When the inner layer of the balloon is made of biodegradable medical polymer material, the inner cavity can also be filled with drug solution or gel.

[0074] The outer surface of the outer layer of the balloon wall may not be loaded with drugs, or the above-mentioned immediate release drug-loaded balloon structure may be selected to load drugs by eluting the outer surface of the outer layer of the balloon wall or adding a structure with grooves to the outer layer of the balloon wall.

[0075] In a preferred embodiment, the drug-loaded rotator cuff balloon can achieve periodic drug release. Based on the above-mentioned time-fixed release drug-loaded balloon structure, a multi-layer multi-cavity balloon structure with drug loading inside the capsule is provided, the innermost cavity is a filling cavity, and the other cavities are drug loading cavities. The outer layer material of each drug loading cavity is selected from biodegradable medical polymer materials. When the outer layer of the drug loading cavity wall is degraded, the drug in the drug loading cavity will contact with human tissue and body fluid, thereby releasing the drug. The outermost layer of the balloon wall contacts the human body fluid first, so the degradation order of the outer layer of the drug loading cavity wall is from the outside to the inside, and the drugs in multiple drug loading cavities are also periodically contacted with human tissue and body fluid after the outer layer is degraded, thereby releasing. Each drug loading cavity can be loaded with the same drug or different types and different uses of drugs according to treatment needs. The quantitative regulation of the degradation time of the outer layer of the drug loading cavity can be achieved by adjusting the polymer composition, polymer segment structure, molecular weight, crystallinity, and capsule wall thickness of the outer layer material of the balloon drug loading cavity. The material of the innermost layer of the balloon (i.e., the outer layer of the filling cavity) can be a degradable biomedical polymer material, or a non-degradable medical polymer material.

[0076] The balloon has a multi-layered wall and a plurality of cavities, wherein the inner cavity is used to fill and expand the balloon, and the other cavities are used to carry drugs. The multi-layered wall can be connected at the balloon tube section or adjacent positions by hot-melt welding to seal the drug-carrying cavity. When the innermost layer of the balloon is made of non-degradable material, the multi-layered wall can also be connected by glue to seal the drug-carrying outer cavity.

[0077] The outer layer of the drug-loading cavity of the balloon is made of biodegradable medical polymer material, and the innermost layer can be made of non-degradable material or biodegradable medical polymer material.

[0078] In a preferred embodiment, the drug-loaded rotator cuff balloon can achieve long-term sustained drug release. The balloon has a similar shape to a drug-free balloon and adopts a single-cavity structure. When the balloon is implanted in the human body, a drug solution or drug gel is injected into the cavity to fill and expand the balloon. The balloon wall adopts a porous polymer membrane. Driven by the concentration difference of drug components inside and outside the balloon and the pressure of bones and human tissues on the balloon, the balloon will continuously release the drug in the balloon through the pore channel to the outside of the balloon at a certain rate. According to the applicable drug molecule size, the pore size of the porous material used in the balloon can be prefabricated into corresponding micropores (pore size <2nm) or mesopores (pore size 2~50nm). In addition, the drug release rate and release time can be quantitatively controlled by adjusting the porosity, pore size, tortuosity factor, thickness and other structural characteristic parameters of the porous membrane of the balloon wall. Compared with other structures, this balloon structure has the advantages of larger drug loading and longer drug release time. The present invention also provides a sponge-type porous drug-loaded implant structure, which is adsorbed and filled with drug solution in the sponge-type structure. After implantation into the human body, the drug solution is released under the pressure of bones and human tissues. The sponge-type implant can be combined with a balloon structure to enhance the support of the entire structure. The implant has a balloon inside and a sponge-like porous drug-carrying structure outside.

[0079] The sponge-type porous structure material adopts a biocompatible medical polymer elastic material, which can be selected from rubber thermosetting elastomers, and thermoplastic elastomers such as polyamide, polyurethane, polyolefin, and styrene. The balloon material in the composite structure adopts a biocompatible medical polymer, which can be selected from polyester, polyamide, polyvinyl chloride, nylon elastomer, polyurethane, etc.

[0080] The rotator cuff balloon can be used in other tissue cavities of the human body, such as the spine, stomach, etc. A person skilled in the art can select any combination of the above technical features according to the needs of the use environment.

[0081] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0082] The above-mentioned embodiments only express several implementation methods of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A rotator cuff balloon, characterized in that: include: A balloon body, the balloon body comprising a restriction structure and a protective structure connected to the restriction structure along a coronal plane, the maximum width of the restriction structure along a sagittal plane being greater than the maximum width of the protective structure along a sagittal plane, the protective structure comprising an arc segment arranged along a horizontal plane at one end away from the restriction structure, the curvature of the arc segment being ≤0.21 mm -1 , the limiting structure includes a first surface and a second surface, the second surface is used to extend from the humeral head to at least partially cover the greater tuberosity, and the curvature radius of the second surface is 10-50 mm; A balloon interface, which is arranged at the opening of the balloon body and is used for allowing a filler to pass through and enter the balloon body; A sealing component, which is arranged at the balloon body and / or the balloon interface and includes a sealing body; An outer catheter is detachably connected to the balloon interface, and the filler enters the opening of the balloon body through the outer catheter.

2. The rotator cuff balloon according to claim 1, characterized in that: The thickness H1 of the protection structure is 4-20 mm, and / or the straight length H2 of the limiting structure along the sagittal plane is H1+15 mm.

3. The rotator cuff balloon according to claim 1, characterized in that: The connecting line of the two end points of the arc segment and the maximum width of the limiting structure forms an isosceles trapezoid.

4. The rotator cuff balloon according to claim 1, characterized in that: The balloon body includes at least two layers of structure, and the materials of the two layers of structure are the same or different.

5. The rotator cuff balloon according to claim 4, characterized in that: The balloon body comprises an inner layer, an outer layer and a drug layer located between the inner layer and the outer layer.

6. The rotator cuff balloon according to claim 1, characterized in that: The sealing body is interference fit with the balloon interface.

7. A rotator cuff balloon, characterized in that: include: A balloon body, a balloon interface and a sealing component, wherein the balloon body comprises at least two layers, both of which are composed of polyethylene, the balloon body comprises a restriction structure and a protective structure connected to the restriction structure along the coronal plane, the maximum width of the restriction structure along the sagittal plane is greater than the maximum width of the protective structure along the sagittal plane, the protective structure comprises an arc segment arranged along a horizontal plane at one end away from the restriction structure, and the curvature of the arc segment is ≤0.21 mm -1 The limiting structure includes a first surface and a second surface, the second surface is used to extend from the humeral head to at least partially cover the greater tuberosity, and the curvature radius of the second surface is 10-50mm.

8. The rotator cuff balloon according to claim 7, characterized in that: The sealing component is arranged at the balloon body and / or the balloon interface, and includes a sealing body, which includes a sealing film that prevents the filling from flowing out of the balloon body, and an outer catheter, which is detachably connected to the balloon interface, and the filling enters the balloon body opening through the outer catheter.

9. The rotator cuff balloon according to claim 8, characterized in that: The sealing body is arranged in the balloon body, and the sealing assembly comprises an auxiliary tube detachably connected to the sealing body, so as to pre-position the sealing body at the opening of the balloon body.

10. The rotator cuff balloon according to claim 7, characterized in that: The connecting line of the two end points of the arc segment and the maximum width of the limiting structure forms an isosceles trapezoid.

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