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WO2024152869A1 - Implant d'articulation d'épaule - Google Patents

Implant d'articulation d'épaule Download PDF

Info

Publication number
WO2024152869A1
WO2024152869A1 PCT/CN2023/142753 CN2023142753W WO2024152869A1 WO 2024152869 A1 WO2024152869 A1 WO 2024152869A1 CN 2023142753 W CN2023142753 W CN 2023142753W WO 2024152869 A1 WO2024152869 A1 WO 2024152869A1
Authority
WO
WIPO (PCT)
Prior art keywords
ring
sealing member
shoulder joint
joint implant
implant according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2023/142753
Other languages
English (en)
Chinese (zh)
Inventor
朱莎莎
李凌晨
蒋冠森
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Alfie Life Science & Biotechnology Co Ltd
Original Assignee
Shanghai Alfie Life Science & Biotechnology Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Alfie Life Science & Biotechnology Co Ltd filed Critical Shanghai Alfie Life Science & Biotechnology Co Ltd
Publication of WO2024152869A1 publication Critical patent/WO2024152869A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/40—Joints for shoulders

Definitions

  • the present application relates to a medical device, and in particular to a shoulder joint implant.
  • the rotator cuff is a general term for the tendon tissues such as the subscapularis, supraspinatus, infraspinatus, and teres minor that cover the front, top, and back of the shoulder joint. It is located below the acromion and deltoid muscle and is closely connected to the joint capsule.
  • the function of the rotator cuff is to pull the humeral head toward the glenoid during the abduction of the upper arm and maintain the normal fulcrum joint between the humeral head and the glenoid. Rotator cuff injury will weaken or even lose this function, seriously affecting the abduction function of the upper limb.
  • the concept of self-sealing expandable rotator cuff components originated overseas. In recent years, it has been recognized by the global academic community as a new concept in rotator cuff treatment, especially for huge, irreparable rotator cuff tears.
  • the principle is to implant an expandable component between the acromion and the humeral head to reduce friction under the acromion, limit the upward movement of the humeral head and assist the sliding of the humeral head, thereby improving pain symptoms and restoring the biomechanical function of the shoulder joint.
  • Patent WO2021129860A1 provides a rotator cuff balloon, as shown in Figure 1.
  • This rotator cuff balloon includes a balloon body, a balloon interface arranged at the opening of the balloon body, a sealing body arranged at the balloon body and/or the balloon interface, and an outer catheter detachably connected to the balloon interface.
  • the balloon body includes a limiting structure and a protective structure with an arc segment curvature of ⁇ 0.21mm-1, and the limiting structure includes a first surface and a second surface, and the curvature radius of the second surface is 10mm-50mm.
  • the filler enters the balloon body from the balloon interface through the outer catheter, and the sealing body is positioned and covered on the balloon interface for sealing.
  • Patent US9770337B2 provides a prosthesis, as shown in Figure 2.
  • This prosthesis includes an inflatable chamber, which defines an opening through which a fluid can flow into the inflatable chamber to fill the inflatable chamber, and defines a single cavity, the single cavity including an outer surface having one or more external features, the external features configured to promote engagement between the outer surface of the single cavity and the one or more cavities.
  • the invention relates to an interface between the tubes, wherein the prosthesis is configured to be located in a void space of a joint between the first tissue and the second tissue, and the inflatable chamber deforms under pressure in response to the articulation of the joint
  • prosthetic devices in the related art rely on the internal and external pressure difference to clamp the plug in a rigid ring, while the filling material in the prosthesis is fluid.
  • This type of prosthetic device has strict requirements on the doctor's operating skills and is prone to the risk of operating failure.
  • Some prosthetic devices are designed as internal plug-type sealing components, and there is a risk of the plug being pulled out of the hard ring during balloon sealing, and both are likely to fail.
  • the present application provides a shoulder joint implant, including:
  • the expandable member includes an orifice and a chamber, the orifice being configured to allow a fill material to pass therethrough into the chamber;
  • a sealing member the sealing member is disposed in the chamber, the sealing member comprises a fixed end, an edge of the fixed end extends toward the orifice to form a locking end;
  • a conveying device wherein the front end of the conveying device is detachably connected to the inner surface of the fixed end of the sealing member;
  • a ring is connected to the orifice, and the ring and the sealing member can be locked to seal the chamber.
  • the sealing component is a locking cap.
  • the conveying device is a catheter, and a gap is provided at the front end of the catheter to allow the filling material to pass through.
  • the ring includes a first end and a second end, and the first end extends a certain length along the orifice toward the chamber, which can ensure that the sealing member and the ring are locked.
  • the inner surface of the locking end and the outer surface of the ring are smooth surfaces with a certain degree of roughness, and the sealing component and the ring are interference fit to achieve locking and sealing.
  • the inner surface of the locking end and the outer surface of the ring are threaded surfaces, and the sealing component cooperates with the ring thread to achieve locking and sealing.
  • the inner surface of the locking end is provided with a convex portion
  • the outer surface of the ring is provided with a concave portion
  • the sealing member cooperates with the ring in a concave-convex manner to achieve locking and sealing.
  • the inner surface of the locking end and the outer surface of the ring are provided with smooth chamfers, so that the sealing component can be more easily buckled on the ring and the sealing effect is better.
  • the expandable member, the sealing member and the ring may be made of at least one material having good biocompatibility and/or biodegradable material.
  • the conveying device when a force greater than a rated force is applied to the conveying device, the conveying device may The sealing member is separated.
  • FIG. 1 is a schematic diagram of the structure of a rotator cuff balloon in the related art.
  • FIG. 2 is a schematic diagram of the structure of a prosthesis in the related art.
  • FIG. 3 is a side cross-sectional view of a shoulder joint implant according to an embodiment of the present application.
  • FIG. 4 is a partial enlarged view of a shoulder joint implant according to an embodiment of the present application.
  • FIG. 5 is a partial enlarged view of a shoulder joint implant according to an embodiment of the present application.
  • FIG. 6 is a schematic structural diagram of a shoulder joint implant according to an embodiment of the present application.
  • FIG. 7 is a partial enlarged view of a shoulder joint implant according to an embodiment of the present application.
  • the raw materials used in the examples are all commercially available industrial products and can be purchased through commercial channels.
  • rated force or “rated force” refers to the force that can separate the conveying device from the sealing member.
  • the present embodiment provides a shoulder joint implant 1000, which includes an expandable member 10, a delivery device 20, a sealing member 30 and a ring 40.
  • the expandable member includes an orifice 101 and a chamber 102.
  • the ring 40 is disposed at the orifice 101, and the orifice 101 and the ring 40 are connected.
  • the delivery device 20 includes a delivery member 201, a front end 20a The delivery member 201 can pass through the ring 40 and fit closely with the ring 40, so that no leakage occurs when the filler is injected into the expandable member 10, but the delivery member 201 is allowed to move linearly along the ring 40.
  • the front end 20a is located in the chamber 102, and the sealing member 30 is disposed at the front end 20a, and the sealing member 30 is connected to the front end 20a.
  • the conveying member 201 is provided with an injection hole 202 near the front end 20a, the diameter of the injection hole 202 is not greater than the diameter of the conveying member 201, and the injection hole 202 is arranged inside the chamber 102, so that the filler can be injected into the expandable member 10 through the injection hole 202.
  • the number of the injection hole 202 is configured as one, and its cross-sectional shape is a perfect circle.
  • the injection hole 202 can have other numbers, such as two, three, etc., and can also have other shapes, such as elliptical, rectangular, etc.
  • a ring 40 is provided at the orifice 101, and the ring 40 includes an inner surface 40i, an outer surface 40o, a first end 40a and a second end 40b.
  • the outer surface 40o of the ring 40 is fixedly connected to the orifice 101.
  • the inner surface 40i of the ring 40 and the outer surface 20o of the conveying device 20 are smooth surfaces, and the two are closely fitted, which can ensure that no leakage occurs when the filler is injected into the expandable member 10, but can allow the conveying member 201 to move linearly along the inner surface 40i of the ring 40.
  • the outer surface 20o of the delivery device 20 can be a smooth surface to simultaneously meet the requirements of no leakage when injecting fillers into the expandable member through the delivery device 20 during surgery, and smooth removal of the delivery device 20 after the injection is completed, without medical accidents such as difficulty in pulling out or breaking. If the surface is too smooth, it may cause leakage when injecting fillers, and if the surface is too rough, it will be difficult to pull out after the injection is completed, thus affecting the surgery.
  • the first end 40a of the ring 40 is disposed inside the expandable member 10, that is, in the chamber 102.
  • the first end 40a extends a certain distance along the orifice 101 to the chamber 102, which can ensure that the sealing member 30 and the ring 40 are locked.
  • the second end 40b of the ring 40 is disposed outside the expandable member 10, that is, the second end 40b extends a certain distance along the orifice 101 to the relative direction of the chamber 102. It should be understood by those skilled in the art that the distance can be zero. In one embodiment, the distance is 3mm-10mm. In the illustrated embodiment, the width of the channel formed by the inner surface 40i of the ring 40 does not change along its length.
  • the width of the channel can also change along the length of the channel.
  • the chamber 102 and the outer surface 40o of the ring 40 have a certain angle. It should be understood by those skilled in the art that the angle is a variable angle, which will change with the injection of the filler, and the angle formed when the filling is finally completed can also be configured as various angles according to actual needs.
  • a sealing member 30 is provided at the front end 20a of the conveying device 20.
  • the sealing member 30 includes a fixed end 301 and a locking end 302.
  • the inner surface 301i of the fixed end 301 is fixedly connected to the front end 20a of the conveying device 20.
  • the edge of the fixed end 301 extends toward the orifice 101 to form the locking end 302.
  • the locking end 302 has a certain length to facilitate the engagement with the ring 40.
  • the inner surface 302i of the locking end 302 and the outer surface 40o of the ring 40 may be smooth surfaces with a certain degree of roughness, and the sealing member 30 and the ring 40 are interference-fitted to achieve locking and sealing.
  • the inner surface 302i of the locking end 302 and the outer surface 40o of the ring 40 may also be threaded surfaces.
  • the inner surface 302i of the locking end 302 may be provided with a convex portion 310, and the outer surface 40o of the ring 40 may be provided with a concave portion 410, so that the sealing member 30 and the ring 40 can achieve concave-convex matching to achieve locking and sealing.
  • the inner surface 302i of the locking end 302 and the outer surface 40o of the ring 40 may also have other textures or surfaces, and the sealing member 30 and the ring 40 may also have other locking forms.
  • the fixed end 301 and the locking end 302 are vertically arranged.
  • the fixed end 301 and the locking end 302 may also be non-vertically arranged, and the fixed end 301 and the locking end 302 may also have other shapes and sizes.
  • the inner surface 302i of the locking end 302 and the outer surface 40o of the ring 40 may also be provided with smooth chamfers, so that the sealing member 30 is easier to buckle on the ring 40, and the sealing effect is better.
  • the height range of the expandable member 10 is 6-20mm, and considering the flexibility of the expandable member 10, the wall thickness range of the chamber 102 is 0.1-0.3mm, the outer diameter range of the ring 40 is 2.0-3.0mm, and the inner diameter range of the sealing member 30 is 1.9-2.9mm.
  • the size of the sealing member 30 and the ring 40 is moderate to prevent a large foreign body sensation after implantation.
  • the implanted parts of the shoulder joint implant 1000 are the expandable member 10 , the sealing member 30 and the ring 40 .
  • the material used to prepare the implant part may be at least one material with good biocompatibility and/or biodegradable materials.
  • at least one of the materials with good biocompatibility and/or biodegradable materials is polyurethane, polyamide, polyester, polyolefin, polylactic acid-glycolic acid copolymer (PLGA), polylactic acid (PLA), polycaprolactone (PCL), poly-L-lactide-caprolactone (PLCL), polydioxanone (PDO), or cellulose.
  • the expandable member 10 is expandable, and optionally, the expandable member 10 is adapted to be at least partially expanded.
  • the expandable member 10 is a non-expandable flexible material.
  • the filler may be a liquid and/or a gel
  • the filler may be biodegradable and/or Or non-biodegradable materials
  • the filler can be water, saline, gel or silicone etc.
  • the delivery device 20 is a metal tube.
  • the delivery device 20 is made of non-absorbable materials such as polyurethane, polyamide, polyester, polyolefin, etc.
  • the delivery device 20 is a combination of a part of non-absorbable material such as polyurethane, polyamide, polyester, polyolefin, etc. and a part of metal material.
  • the expandable member 10 is circular or elliptical after filling.
  • shape of the expandable member 10 after filling can be any shape suitable for implantation between the acromion and the humeral head, which can achieve the surgical effect while allowing the patient relatively unimpeded or free shoulder movement.
  • the delivery device 20 injects the filler into the expandable member 10 to the rated volume through the injection hole 202, and the delivery device 20 withdraws and moves linearly toward the terminal 20b, and the sealing member 30 moves accordingly and fastens to the outer surface of the ring 40, and the sealing member 30 and the ring 40 are locked.
  • the delivery device 20 is continued to be moved, and the delivery device 20 is pulled off or twisted off, and the delivery device 20 is separated from the sealing member 30, and the shoulder joint implant 1000 is sealed.
  • the separation breakpoint of the delivery device 20 and the sealing member 30 can be the connection point of the delivery device 20 and the sealing member 30, and can also be any position between the connection point of the delivery device 20 and the sealing member 30 and the orifice 101.
  • the sealing member 30 and the ring 40 and the matching mode of the two provided in the shoulder joint implant 1000 of the present application achieve a high sealing strength, which can effectively avoid the risk of failure of the supporting function of the expandable member 10 caused by the seal being pulled out or the sealing component being separated.
  • the numerical range represented by the endpoint includes all values within the range.
  • the height range of the expandable member is 6-20 mm, including 6 mm, 6.1 mm, 6.5 mm, 7 mm, 8.5 mm, 15.86 mm, 19.389 mm, 20 mm, etc.

Landscapes

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

Abstract

L'invention concerne un implant d'articulation d'épaule (1000). L'implant d'articulation d'épaule (1000) comprend un élément extensible (10), un appareil de pose (20), un élément d'étanchéité (30) et un anneau (40). L'élément d'étanchéité (30) comprend une extrémité fixe (301) et une extrémité de verrouillage (302). L'appareil de pose (20) est relié de manière amovible à l'extrémité fixe (301) de l'élément d'étanchéité (30). La bague (40) et l'élément d'étanchéité (30) peuvent être en liaison verrouillée.
PCT/CN2023/142753 2023-01-19 2023-12-28 Implant d'articulation d'épaule Ceased WO2024152869A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202320165088.7U CN219680868U (zh) 2023-01-19 2023-01-19 一种肩关节植入物
CN202320165088.7 2023-01-19

Publications (1)

Publication Number Publication Date
WO2024152869A1 true WO2024152869A1 (fr) 2024-07-25

Family

ID=87962249

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2023/142753 Ceased WO2024152869A1 (fr) 2023-01-19 2023-12-28 Implant d'articulation d'épaule

Country Status (2)

Country Link
CN (1) CN219680868U (fr)
WO (1) WO2024152869A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN219680868U (zh) * 2023-01-19 2023-09-15 上海埃尔翡生命科技有限公司 一种肩关节植入物

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013057566A2 (fr) * 2011-10-18 2013-04-25 Ortho-Space Ltd. Dispositifs prothétiques et procédés d'utilisation associés
CN105232325A (zh) * 2015-09-28 2016-01-13 黄丽萍 一种密封性良好的简易药瓶
CN109367946A (zh) * 2018-11-01 2019-02-22 肇庆乐创科技有限公司 一种滴眼液瓶
CN112439641A (zh) * 2019-09-02 2021-03-05 艾克赛尔工业公司 阀、包括这种阀的用于涂覆覆盖产品的系统以及专用安装和拆卸工具
CN216148282U (zh) * 2021-09-01 2022-04-01 上海竞捷医疗科技有限公司 输送装置以及假体系统
CN115998489A (zh) * 2023-01-19 2023-04-25 上海埃尔翡生命科技有限公司 一种肩关节植入物
CN219680868U (zh) * 2023-01-19 2023-09-15 上海埃尔翡生命科技有限公司 一种肩关节植入物

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013057566A2 (fr) * 2011-10-18 2013-04-25 Ortho-Space Ltd. Dispositifs prothétiques et procédés d'utilisation associés
CN105232325A (zh) * 2015-09-28 2016-01-13 黄丽萍 一种密封性良好的简易药瓶
CN109367946A (zh) * 2018-11-01 2019-02-22 肇庆乐创科技有限公司 一种滴眼液瓶
CN112439641A (zh) * 2019-09-02 2021-03-05 艾克赛尔工业公司 阀、包括这种阀的用于涂覆覆盖产品的系统以及专用安装和拆卸工具
CN216148282U (zh) * 2021-09-01 2022-04-01 上海竞捷医疗科技有限公司 输送装置以及假体系统
CN115998489A (zh) * 2023-01-19 2023-04-25 上海埃尔翡生命科技有限公司 一种肩关节植入物
CN219680868U (zh) * 2023-01-19 2023-09-15 上海埃尔翡生命科技有限公司 一种肩关节植入物

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