WO2021139573A1 - 肩袖球囊 - Google Patents

肩袖球囊 Download PDF

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Publication number
WO2021139573A1
WO2021139573A1 PCT/CN2020/141109 CN2020141109W WO2021139573A1 WO 2021139573 A1 WO2021139573 A1 WO 2021139573A1 CN 2020141109 W CN2020141109 W CN 2020141109W WO 2021139573 A1 WO2021139573 A1 WO 2021139573A1
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WO
WIPO (PCT)
Prior art keywords
balloon
rotator cuff
sealing
restriction
interface
Prior art date
Application number
PCT/CN2020/141109
Other languages
English (en)
French (fr)
Inventor
岳斌
刘琛
Original Assignee
上海竞捷医疗科技有限公司
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 上海竞捷医疗科技有限公司 filed Critical 上海竞捷医疗科技有限公司
Priority to IL294462A priority Critical patent/IL294462A/en
Priority to CA3163858A priority patent/CA3163858A1/en
Priority to US17/790,867 priority patent/US20230019753A1/en
Priority to EP20912001.3A priority patent/EP4066785A4/en
Priority to JP2022541619A priority patent/JP7408818B2/ja
Publication of WO2021139573A1 publication Critical patent/WO2021139573A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61F2002/0894—Muscles
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A61F2002/30064—Coating or prosthesis-covering structure made of biodegradable material
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • A61F2002/30548—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting fluid pressure
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30589—Sealing means
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • 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
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30688—Means for allowing passage or sliding of tendons or 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30971—Laminates, i.e. layered products
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0061—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/0097—Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics

Definitions

  • This application relates to the field of medical devices, and in particular to a rotator cuff balloon.
  • the rotator cuff is a muscle-tendon structure that connects the scapula and humeral head. It is located on the outer layer of the shoulder joint capsule and the inner layer of the deltoid muscle.
  • the rotator cuff is composed of the front rotator cuff (subscapularis muscle), upper rotator cuff (supraspinatus), and back rotator cuff (infraspinatus and teres minor).
  • the rotator cuff has certain internal rotation, external rotation and external rotation of the upper arm.
  • the rotator cuff plays an extremely important role in the maintenance of the stability of the shoulder joint and the movement of the shoulder joint.
  • long-term repeated shoulder joint activities, subacromial bone hyperplasia, or repeated strenuous activities may cause wear and tear of the subacromial soft tissues (joint bursa, rotator cuff), and make the humerus The stability and mobility of the head are impaired.
  • the patient’s arm cannot be abducted or raised, and the impact between the bone or the bone and the rotator cuff brings severe pain.
  • the patient cannot sleep at night and is serious. Affect the quality of life and self-care ability.
  • the current treatment methods for rotator cuff injuries mainly include surgical treatment and implantation of prostheses.
  • surgical treatment can obtain better results, but for injuries greater than 3 cm, the surgical treatment effect is not clear and is prone to recurrence.
  • Prosthesis implantation is to artificially limit the upward movement of the humeral head to avoid the pain caused by the impact between tissues. It also increases the force arm of the deltoid muscle, which can immediately improve the patient's shoulder joint function.
  • the prosthesis implants in the prior art such as prosthetic devices, bio-gaskets, etc., may be displaced during the movement of the patient. For example, the displacement of the prosthetic device may change the pressure distribution and cause the prosthesis to rupture for a long time.
  • the content that has deteriorated at 37° is released, causing further damage to the affected area, and the injection hole has a hard material, which may cause discomfort and foreign body sensation to the patient under certain actions after implantation.
  • the displacement of the bio-gasket may cause discomfort, restriction of movement, and even damage to the surrounding soft tissues, which may cause further injury.
  • the prosthetic implants in the prior art may fail.
  • this application discloses a rotator cuff balloon, which is characterized in that it comprises:
  • the balloon body includes a restriction structure and a protection structure connected to the restriction structure, the maximum width of the restriction structure is greater than the maximum width of the protection structure, the protection structure includes an arc segment, the curvature of the arc segment is ⁇ 0.21mm -1 , the restriction structure includes a first surface and a second surface, the second surface has a radius of curvature of 10mm-50mm; a balloon interface, the balloon interface is arranged at the opening of the balloon body for For the filler to pass through and enter the balloon body; a sealing assembly, the sealing assembly is arranged at the balloon body and/or the balloon interface, including a sealing body; an outer catheter, the outer catheter and the balloon interface can be Removably connected, the filler enters the balloon body from the balloon interface through the outer catheter.
  • the height H1 of the protection structure is 4mm-20mm
  • the height H2 of the restriction structure is H1+15mm.
  • the protection structure includes an arc segment, and two end points of the arc segment and the point at the maximum width of the restriction structure are connected to form an isosceles trapezoid.
  • the balloon body includes at least a two-layer structure, and the material of the two-layer structure is selected from one or a combination of polyethylene, polyamide, polyester, polyurethane, polylactic acid, or polycaprolactone.
  • the balloon body includes an inner layer, an outer layer, and a drug layer located between the inner layer and the outer layer.
  • the outer layer is composed of a degradable polymer material
  • the drug layer includes at least one of the following drugs: diclofenac diethylamine, fentanyl and its analogs, etorphine and the like Drugs, ⁇ 2 receptor agonists medetomidine, droperidol, etonamidinolate, vecuronium and its analogues, procaine hydrochloride, tetracaine hydrochloride, lidocaine hydrochloride , Antibiotics, cephalosporin anti-inflammatory drugs.
  • a rotator cuff balloon which includes a balloon body, a balloon interface and a sealing component.
  • the balloon body includes at least two layers of structure, both of which are made of polyethylene.
  • the balloon body includes a restriction structure and a protection structure connected to the restriction structure, the maximum width of the restriction structure is greater than the maximum width of the protection structure, the protection structure includes an arc segment, the curvature of the arc segment is ⁇ 0.21mm -1 , the restriction structure includes a first surface and a second surface, and the radius of curvature of the second surface is 10mm-50mm.
  • the height H1 of the protective structure is 4mm-20mm.
  • the sealing assembly is disposed at the balloon body and/or the balloon interface, and includes a sealing body, the sealing body includes a sealing film that prevents the filling from flowing out of the balloon body, and the sealing assembly further includes an outer A catheter, the outer catheter is detachably connected with the balloon interface, and the filler enters the balloon body from the balloon interface through the outer catheter.
  • the sealing body is arranged in the balloon body, and the sealing assembly includes an auxiliary tube detachably connected with the sealing body for pre-positioning the sealing body at the balloon interface.
  • the protection structure includes an arc segment, and two end points of the arc segment and the point at the maximum width of the restriction structure are connected to form an isosceles trapezoid.
  • the rotator cuff balloon provided in this application 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.
  • the protective structure is used to support the human body in the gap between the humeral head and the acromion of the shoulder joint to achieve the supporting effect.
  • the humeral head of the patient with rotator cuff injury moves up, avoiding the pain caused by the impact between tissues, and further increasing
  • the force arm of the deltoid muscle can immediately improve the function of the patient's shoulder joint, and the restriction structure is used to at least partially fit the humeral head of the human shoulder joint to play a limiting role and avoid the displacement of the prosthesis.
  • the first surface and the second surface of the restriction structure of the rotator cuff balloon provided in the present application are both curved surfaces, so that the restriction structure is fully or partially fitted with the human humeral head or the greater tuberosity, so that the restriction structure can be used.
  • the edge of the restriction structure of the rotator cuff balloon provided by the present application is arc-shaped, and the arc-shaped structure can be adapted to the physiological shape of the shoulder joint and the top of the rotator cuff, and will not restrict the patient's activity and will not damage the surrounding soft tissues.
  • the restrictive structure of the rotator cuff balloon provided in the present application has a first accommodating cavity, and the protective structure has a second accommodating cavity communicating with the first accommodating cavity.
  • the protective structure After fillings are injected into the restricting structure and the protective structure, the protective structure It can fit the rotator cuff to avoid the impact 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 arm of the shoulder joint, and reduce the muscle load;
  • the humeral head of the shoulder joint of the human body is tightly occluded to improve the limiting ability.
  • the restriction structure and the protective structure can be filled with liquid, colloid or gas 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 injury, and the special shape of the prosthesis adapts to the special physiology of the human shoulder joint
  • the structure achieves better support, reduces impact, and obtains better treatment effects.
  • the rotator cuff balloon provided by the present application reduces the possible foreign body sensation caused to the patient after the implantation of the prosthesis.
  • the height of the structure is limited It gradually increases from the end away from the protective structure to the end connected to the protective structure, that is, the restricting structure is designed to be thinner on the outside and gradually thicker toward the proximal end, which can reduce the influence of the restricting structure on the humeral head during activities.
  • the rotator cuff balloon provided by the present application can effectively realize the airtightness of the balloon body, avoid filling liquid or gel from flowing out of the balloon, and has a simple structure.
  • Figure 1 is a schematic diagram of various anatomical surfaces of the human body
  • FIG. 2 is a schematic side sectional view of the rotator cuff balloon after inflation according to an embodiment of the application;
  • Figure 3 is a schematic top view of the rotator cuff balloon shown in Figure 1;
  • Figure 4 is a schematic diagram of the rear view of the rotator cuff balloon shown in Figure 1;
  • Figure 5 is a schematic front view of the rotator cuff balloon shown in Figure 1;
  • Figure 6 is a schematic side view of the rotator cuff balloon shown in Figure 1;
  • Fig. 7 is a schematic diagram of the cooperation between the rotator cuff balloon shown in Fig. 1 and the human body;
  • Figure 8 is a side view of the rotator cuff balloon of another embodiment; where 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, and H1 is the rotator cuff ball The height of the protective structure in the capsule along the sagittal plane, H2 is the height of the rotator cuff balloon along the sagittal plane;
  • L3 is the width of the protective structure in the rotator cuff balloon along the horizontal plane
  • L4 is the width of the restriction structure in the rotator cuff balloon along the horizontal plane
  • Figure 10 is a schematic top view of a rotator cuff balloon according to another embodiment
  • Figure 11 is a schematic top view of a rotator cuff balloon according to another embodiment
  • Fig. 12 is a schematic diagram of the sealing structure of the rotator cuff balloon according to another embodiment.
  • the sagittal plane 101 refers to the longitudinal section that divides the human body or joints into left and right parts from the front to back direction.
  • the sagittal plane passing through the center of the human body is the median sagittal plane, which divides the human body into two equal left and right sides.
  • coronal plane 102 refers to the longitudinal section that divides the human body or joints into front and rear parts from the left and right directions, which is perpendicular to the sagittal plane; horizontal plane 103: also called the transverse plane, which is parallel to the ground plane and the human body or joints A plane divided into upper and lower parts, which are perpendicular to the coronal and sagittal planes.
  • an embodiment of the present application provides a rotator cuff balloon 10, which includes a restriction structure 100 and a protection structure 200 connected to the restriction structure 100.
  • the restricting structure 100 has an arc along the coronal plane, or the restricting structure 100 and the protective structure 200 have an angle along the coronal plane.
  • the restriction structure 100 has a curvature along 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.
  • the restriction structure 100 has a first surface and a second surface, and both the first surface and the second surface of the restriction structure 100 are curved surfaces, for example, the second surface is an inner surface (a downwardly facing surface as shown in FIG. 2 ).
  • the second surface is used to fully or partially fit the humeral head and/or the greater tubercle, and the second surface extends from the humeral head to at least partially cover the greater tubercle.
  • the second surface of the restriction structure 100 partially or completely covering the greater tuberosity can prevent the prosthesis from displacing and detaching during activities such as abduction and internal rotation of the arm, and at the same time, the prosthesis can be removed from the prosthesis.
  • the torn wound of the rotator cuff tendon is protected inside the restriction structure of the prosthesis, which further avoids the severe pain of the patient caused by the impact of the tear wound with the bone.
  • the restricting structure 100 can exert the best restricting effect, and to the greatest extent, avoid the displacement of the rotator cuff balloon.
  • the restricting structure 100 may be a half-bowl-shaped structure, and the restricting structure 100 of the half-bowl-shaped structure can fit the humeral head to maintain the position of the entire rotator cuff balloon.
  • the structure and shape of the restriction structure 100 are not limited to those described above, and the structure and shape of the restriction structure 100 may also be a half pot-like structure or a half-bowl-like structure.
  • the protective structure 200 is used to support the acromion in the gap between the humeral head of the human shoulder joint and the acromion.
  • the edge of the limiting structure 100 is arc-shaped along the sagittal plane, and the edge of the limiting structure 100 is smooth.
  • This arc-shaped structure can adapt to the physiological shape of the shoulder joint and the top of the rotator cuff, reducing When the shoulder joint is moving, the damage of the outer edge of the structure 100 to the muscle tissue is restricted.
  • the maximum width of the restriction structure 100 is greater than the maximum width of the protection structure 200.
  • the width L4 at the transition position of the restriction structure 100 and the protection structure 200 is shown. It is larger than the width L3 of the protective structure 200.
  • the restriction structure 100 and/or the protection structure 200 can be deformed, and the deformation may be a restorative deformation after compression, an expansive deformation after being filled with a filler, or other forms of deformation.
  • the restriction structure 100 and/or the protection structure 200 can be deformed to fit the gap between the humeral head of the human shoulder joint, 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 and reduce impact Objective, to obtain a better treatment effect.
  • the restricting structure 100 and/or the protective structure 200 can 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 and at the same time cooperate with the bursa folds of the shoulder joint.
  • the reflexed physiological structure can limit the internal and external displacement of the rotator cuff balloon on the shoulder joint, and it can be limited to the subacromial space to avoid dislocation.
  • the self-adaptive function brought about by deformation makes the restriction structure 100 and the protection structure 200 not interfere with each other. The patient’s activities are restricted and the surrounding soft tissues will not be damaged.
  • H1 is the size of the protective structure 200 in the rotator cuff balloon 10 along the sagittal plane, that is, the height of the protective structure 200, which is preferably 4-20 mm.
  • P the maximum pressure that the cavity can withstand
  • h the wall thickness of the cavity shell
  • r the smallest radius of the cavity.
  • the selection of the prosthesis material and the specific design of the wall thickness For example, when the wall thickness h of the shoulder joint prosthesis is 0.1mm, at least the material with the strength ⁇ of the prosthesis material in the range of 1760-8800KPa can be selected.
  • H1 is preferably 4-20 mm, which can realize the function of the protective structure of supporting the humeral head and acromion of the shoulder joint prosthesis under the conditions of commonly used medical materials and conventional manufacturing accuracy.
  • H2 is the height of the rotator cuff balloon 10 along the sagittal plane, which is preferably 9-34 mm. More preferably, the linear dimension of the restricting structure 100 along the sagittal plane, that is, the height H2 of the restricting structure 100 is H1+15mm. This arrangement can realize that the restricting structure 100 covers the greater tuberosity of the humeral head and avoids the restriction structure 100 from being too large. And hinder the movement of the rotator cuff muscles.
  • 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.
  • 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 restriction structure 100 in the rotator cuff balloon 10 along the horizontal plane, which is preferably 20-70 mm.
  • rotator cuff balloons 10 of different sizes are suitable for humeral heads of different diameters.
  • H1 is preferably 10-12mm
  • H2 is 25-27mm
  • L1 is 55-65mm
  • L2 is 25-35mm
  • L3 is 30-50mm
  • L4 is 55-60mm.
  • the radius of curvature of the inner surface of the structure 100 is 25-30 mm.
  • the height H2 of the restriction structure 100 gradually increases from the end away from the protection structure 200 to the end connected to the protection structure 200.
  • Fig. 10 is a top view of another embodiment of the shoulder joint prosthesis.
  • the end points of the restriction structure 100 at its maximum width include point D and point C
  • the protection structure 200 includes an arc segment, and the end points of the arc segment constitute point A and point B.
  • the connection of the points A, B, C, and D constitutes an isosceles trapezoid.
  • This structure can improve the transmission of horizontal force between the AB side and the CD side of the protective structure.
  • the humeral head is facing the shoulder
  • the inner side of the socket rotates to form a horizontal force from CD to AB on the protection structure, causing horizontal extrusion between the protection structures.
  • the large-angle trapezoidal profile design reduces the loss of force transmission between the two edges, so it can Reduce the internal strain of the protective structure in the dynamic process of arm abduction, which leads to deformation and folds. More preferably, the curvature of the arc segment AB is less than or equal to 0.21 mm -1 , and the curvature of the arc segment of the CD segment is less than or equal to 0.15 mm -1 .
  • the points A and D in FIG. 9 can be connected by one or more straight segments, connected by one or more arc segments, or connected by straight segments and arc segments.
  • the arc between point A and point C includes arc AB and arc BC
  • the arc between point D and F includes arc DE and arc EF
  • the curvature of the arcs of AB and EF is preferably ⁇ 0.3mm -1
  • the curvature of the arcs of the BC section and the DE section is preferably ⁇ 0.15mm -1 .
  • the limiting structure 100 has a first accommodating cavity 110
  • the protection 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 for filling ⁇ 600 filled.
  • the protective structure 200 can fit the rotator cuff to avoid 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 head of the humerus and the acromion can maintain the length of the active arm of the shoulder joint and reduce the muscle load; the restriction structure 100 can closely occlude the humeral head of the human shoulder joint to improve the limiting ability.
  • the restriction structure 100 and the protection structure 200 may be balloons, sponge-like elements, or non-expandable structures.
  • the maximum height of the restriction structure 100 gradually changes from the end away from the protection structure 200 to the end connected to the protection structure 200.
  • the minimum height of the restriction structure 100 is the height before filling with the filler or the height after the restriction structure 100 is compressed; the maximum height of the restriction structure 100 is the height after filling with the filler or the height of the self-recovery state after the restriction structure 100 is compressed.
  • the minimum height of the protective structure 200 is the height before filling with the filler or the height after compressing the protective structure 200; the maximum height of the protective structure 200 is the height after filling with the filler or the height after compressing the protective structure 200 in a self-recovering state.
  • the height of the limiting structure 100 gradually changes from the end away from the protective structure 200 to the end connected to the protective structure 200. Increase.
  • the height of the restricting structure 100 is moved away from the protective structure
  • the end of 200 to the end connected to the protection structure 200 gradually increases, that is, the restriction structure 100 is designed to be thinner on the outside and gradually thicker toward the proximal end, which can reduce the influence of the restriction structure 100 on the humeral head during movement.
  • the bladder wall of the protective structure 200 can be specifically optimized for different usage requirements. For example, those with more sports needs can be appropriately thickened in order to increase the service life.
  • the height of the end connecting the restriction structure 100 and the protection structure 200 is the same as the height of the protection structure 200, so as to reduce the shoulder joints. Discomfort of the humeral head during activity.
  • the protective structure 200 is curved so that the surface and the rotator cuff are basically fit.
  • the protective structure 200 is a downwardly curved arc structure on the horizontal axis. This arc structure is compatible with 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 shoulder Cuff, and avoid the impact 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 arm of the shoulder joint movement, and reduce the muscle load.
  • the restriction structure 100 and/or the protection structure 200 are provided with an injection hole 300, the injection hole 300 is connected to the first housing cavity 110 and the second housing cavity 210, and the injection hole 300 A one-way valve 500 is provided inside, and the one-way valve 500 can prevent the filling 600 injected through the injection hole 300 from flowing out in the reverse direction.
  • the above-mentioned rotator cuff balloon 10 further includes an injection tube 400 arranged in the first accommodating cavity 110 and/or in the second accommodating cavity 210 and connected to the injection hole 300,
  • the nozzle of the injection pipe 400 facing outward is flush with the outer surface of the restriction structure 100 or the protection structure 200, and the one-way valve 500 is disposed in the injection pipe 400.
  • the diameter of the end of the injection pipe 400 that communicates with the injection hole 300 is smaller than that of the end facing inward.
  • the injection tube 400 is flexible, which effectively solves the problems in the traditional technology that may cause discomfort and foreign body sensation to the patient under specific actions after implantation.
  • restriction structure 100 and the protection structure 200 are connected in an integrated structure.
  • the design of the restriction structure 100 and the protection structure 200 as an integrated structure facilitates mold opening and processing and low manufacturing cost.
  • restriction structure 100, the protection structure 200, and the injection tube 400 are all made of non-degradable materials.
  • the restricting structure 100 and the protective structure 200 of the rotator cuff balloon 10 of the present application are made of non-degradable materials, which solves the problem of degradation and failure of the implant in the traditional technology in a short time, and prevents the rotator cuff balloon 10 from rupturing. It can work effectively for a long time at a temperature of 37°, effectively preventing further damage to the affected area caused by the release of the deteriorated filling.
  • the preparation materials of the restriction structure 100 include, but are not limited to, one or more of silica gel, polyurethane, rubber, polyamide, polyester, and polyolefin.
  • the preparation material of the protective structure 200 includes, but is not limited to, one or more of silica gel, polyurethane, rubber, polyamide, polyester, and polyolefin.
  • the preparation materials of the injection tube 400 include, but are not limited to, one or more of silicone, polyurethane, rubber, polyamide, polyester, and polyolefin.
  • the balloon in order to make the rotator cuff balloon 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 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.
  • the above-mentioned rotator cuff balloon 10 further includes a filler 600, and the filler 600 is filled in the first accommodating cavity 110 and the second accommodating cavity 210.
  • the filling 600 includes liquid and/or colloid.
  • the filling 600 is water, silica gel, or gel.
  • Figure 12 shows a schematic cross-sectional view of the sealing assembly of the rotator cuff balloon disclosed in the present application, where the sealing assembly includes a sealing body 9 built in the balloon body 7 and an auxiliary tube detachably connected to the sealing body 9 11.
  • the sealing body 9 can be positioned and covered on the balloon interface 8 through the auxiliary tube 11.
  • the auxiliary tube 11 is connected to the sealing body 9 in advance, and then the outer catheter 1 is connected to the balloon interface 8.
  • the auxiliary tube 11 is pushed to push the sealing body 9 to open the cavity of the balloon body 7, and the balloon body 7 is filled through the annular gap between the outer catheter 1 and the auxiliary tube 11.
  • the sealing body 9 is attached to the opening of the balloon body 7 under the pressure of the inner filling of the balloon body 7. At this time, the outer catheter 1 and the auxiliary tube 11 are removed and withdrawn from the living body, and the balloon body 7 can be sealed 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 a pulling force to the auxiliary tube 11, the sealing body 9 is pressed against the opening of the balloon body 7 and the weak area 12 is broken.
  • an end of the sealing body 9 and the auxiliary tube 11 may be provided with mutually matched threads, or one end of the sealing body 9 may be an interference fit with the auxiliary tube 11.
  • the present application provides an implanted prosthesis, which includes at least two layers of structure, the inner layer is a sealing structure, and the drug layer is located on all or part of the surface of the inner layer.
  • the inner layer can be filled with liquid or semi-solid.
  • the implantable prosthesis may also include an outer layer, and the drug layer is located between the inner layer and the outer layer.
  • the drug layer may be a liquid drug or a solid drug.
  • the outer layer can be a degradable material or a porous material.
  • the surface or inside of the rotator cuff balloon provided in this application can be loaded with medicine.
  • the drug-loaded rotator cuff balloon can realize immediate drug release.
  • the outer surface of the balloon contacts human tissues and body fluids, thereby releasing the ball immediately Drugs on the outer surface of the capsule.
  • the outer surface of the balloon can be loaded with a drug coating by elution. Further, prefabricated grooves can be passed on the outer surface of the balloon to increase the drug loading.
  • the surface of the balloon can be loaded with drugs that promote the recovery of injured tendons or relieve pain, analgesia, or anti-inflammatory, so as to promote the growth and recovery of torn tendons or reduce pain or eliminate inflammation in patients.
  • the balloon can be eluted or loaded with drugs through a structure with grooves on the outer layer of the balloon wall.
  • the drugs loaded by the balloon can be selected from diclofenac diethylamine, fentanyl and its analogues, etorphine and its analogues, ⁇ 2 receptor agonist medetomidine, droperidol, etonamide , Vecuronium bromide and its analogues, procaine hydrochloride, tetracaine hydrochloride, lidocaine hydrochloride, antibiotics, cephalosporin anti-inflammatory drugs, and other anti-inflammatory drugs capable of promoting tendon repair or relieving pain or One or more combinations of drugs that eliminate inflammation.
  • the balloon can be filled and expanded with gas, liquid or gel, and the filling composition can be determined according to the needs of the doctor.
  • the balloon filling material can be a drug solution or gel, and the balloon material can be a biodegradable medical polymer material. When the balloon is degraded, the drug inside the balloon can be released to the lesion.
  • the drug-loaded rotator cuff balloon can realize timed drug release.
  • the rotator cuff balloon is a double-layer two-cavity balloon structure, the outer cavity is used for storing medicine, and the inner cavity is used for filling and expanding the balloon.
  • the outer layer of the balloon is made of biodegradable medical polymer materials. When the outer wall of the balloon is degraded, the outer cavity of the double-layered two-cavity balloon will contact human tissues and body fluids to release the drug. Therapeutic effect. Quantitative control of the degradation time of the balloon outer layer can be achieved by adjusting the polymer composition, polymer segment structure, molecular weight, crystallinity, and thickness of the balloon wall of the balloon outer layer material.
  • the inner layer material of the balloon can be either degradable biomedical polymer materials or non-degradable medical polymer materials.
  • the balloon can be filled with gas, liquid or gel to fill the inner cavity and expand the balloon, and the filling composition can be determined according to the needs of the doctor.
  • the inner layer of the balloon is made of biodegradable medical polymer materials
  • the inner cavity can also be filled with a drug solution or gel.
  • the outer surface of the outer layer of the balloon wall may not be loaded with drugs, or the above-mentioned immediate-release drug-loading balloon structure may be used, by eluting on the outer surface of the outer wall or adding a structure with grooves on the outer layer of the wall Load medicine.
  • the drug-loaded rotator cuff balloon can achieve periodic drug release.
  • a multi-layer multi-lumen balloon structure for loading drugs inside the balloon is provided, the innermost cavity is a filling cavity, and the other cavities are drug-loading cavities.
  • the outer layer material of each drug-carrying cavity is made of biodegradable medical polymer material. When the outer capsule wall of the drug-carrying cavity is degraded, the drug in the drug-carrying cavity will come into contact with human tissues and body fluids, thereby releasing the drug.
  • the outermost wall of the balloon is the first to contact human body fluids, so the degradation order of the outer wall of the drug-loading cavity is layer by layer from the outside to the inside, and the drugs in multiple drug-loading cavities are periodically degraded with the outer layer. Contact with human tissues and body fluids to release.
  • Each medicine-loading cavity can be loaded with the same medicine or different kinds of medicines for different purposes according to the treatment needs.
  • Quantitative control of the degradation time of the outer layer of the drug-carrying cavity can be achieved by adjusting the polymer composition, polymer segment structure, molecular weight, crystallinity, and thickness of the capsule wall of the outer layer of the drug-carrying cavity of the balloon.
  • the material of the innermost layer of the balloon (that is, the outer layer of the filling cavity) can be a degradable biomedical polymer material or a non-degradable medical polymer material.
  • the balloon has a multi-layered wall and multiple cavities, the inner cavity is used for filling and expanding the balloon, and the other cavities are used for loading medicine.
  • the multi-layer balloon wall can be connected at or adjacent to the balloon tube section by hot-melt welding to seal the drug-carrying cavity.
  • the multiple walls of the balloon can also be connected by glue to seal the outer cavity of the drug.
  • the outer layer of the drug-carrying cavity of the balloon is made of biodegradable medical polymer materials, and the innermost layer can be made of non-degradable materials or biodegradable medical polymer materials.
  • the drug-loaded rotator cuff balloon can achieve long-term sustained drug release.
  • the shape of the balloon is similar to that of a drug-free balloon. It adopts a single-cavity structure.
  • a drug solution or a drug gel is injected into the cavity to fill and expand the balloon.
  • the balloon wall adopts a porous polymer membrane, which is driven by the difference in the concentration of drug components inside and outside the balloon and the pressure of the bone and human tissue on the balloon. The balloon will continue to push the drug in the balloon through the pore channel at a certain rate. Released outside the balloon.
  • 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).
  • the drug release rate and release time can be quantitatively controlled.
  • the balloon structure has the advantages of larger drug loading capacity and longer drug release time.
  • the application also provides a sponge-type porous drug-loaded implant structure, in which the sponge-type structure is filled with a drug solution. After implantation in the human body, the drug solution is released under the pressure of bones and human tissues.
  • the sponge implant can be combined with the balloon structure to form a composite structure to improve the supporting force of the entire structure.
  • the implant has a balloon inside and a sponge-like porous drug-carrying structure outside.
  • the sponge-type porous structure material adopts biocompatible medical polymer elastic materials, and 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 biocompatible medical polymers, and can be selected from polyesters, polyamides, polyvinyl chloride, nylon elastomers, polyurethanes, and the like.
  • the rotator cuff balloon can be used in other human tissue cavities, such as the spine and stomach.
  • a person of ordinary skill in the art can select any combination of the above technical features according to the needs of the use environment.

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Abstract

一种肩袖球囊（10），肩袖球囊（10）包括限制结构（100）以及连接于限制结构（100）的保护结构（200）；限制结构（100）沿冠状面具有弧度。肩袖球囊（10）符合人体肩关节生理结构，自限于肩峰下间隙，能够减少患者异物感、脱位、功能失效等不良事件发生。

Description

肩袖球囊 技术领域
本申请涉及医疗器械领域，特别是涉及一种肩袖球囊。
背景技术
肩袖是连接肩胛骨和肱骨头的肌肉-肌腱结构，位于肩关节囊的外层，三角肌的内层。肩袖由前肩袖(肩胛下肌)、上肩袖(冈上肌)、后肩袖(冈下肌和小圆肌)构成，肩袖除了有一定的使上臂内旋、外旋和外展的功能，更主要的功能是能稳定肱骨头在关节盂上的位置，避免肱骨头上移撞击肩峰造成疼痛等。因此，肩袖在肩关节的稳定性的维持以及肩关节活动过程中扮演极其重要的角色。然而随着年龄增长，长期反复的肩关节活动、肩峰下骨质增生，或是反复剧烈的活动，可能会造成肩峰下软组织(关节滑囊、肩袖)的磨损、撕裂，使得肱骨头的稳定性、活动性受损，在肩关节活动过程中患者手臂无法外展、上举等，并由于骨质间或骨质与肩袖的撞击带来剧烈的疼痛，患者夜不能眠，严重影响生活质量以及自理能力。
目前肩袖损伤治疗方式主要包括手术治疗和假体植入等。对于程度较轻的肩袖损伤，手术治疗可获得较好的结果，但大于3cm的损伤，手术治疗效果不明确且容易复发。假体植入是人为地限制肱骨头上移，避免组织间撞击造成的疼痛，也进而增加了三角肌施力力臂，得以即刻改善患者肩关节功能。现有技术中的假体植入如假体装置、生物垫片等在患者活动过程中，可能会出现移位，例如假体装置的移位可能造成压力分布改变，使假体破裂，且长期处于37°下变质的内容物释出，造成患部的进一步损伤，且其注入孔具有硬质材料，在植入后，特定动作下可能造成患者不适、异物感。生物垫片的移位可能使患者出现不适、活动限制，甚至是损伤周围软组织，进一步造成伤害。除此之外，现有技术中的假体植入物存在失效可能。
发明内容
基于此，有必要提供一种符合人体肩关节生理结构，自限于肩峰下间隙 以解决植入物移位问题，减少不良事件发生的肩袖球囊。
为了实现上述发明目的，本申请公开一种肩袖球囊，其特征在于，包括：
球囊本体，该球囊本体包括限制结构以及连接于该限制结构的保护结构，该限制结构的最大宽度大于该保护结构的最大宽度，该保护结构包括弧线段，该弧线段的曲率为≤0.21mm -1，该限制结构包括第一面和第二面，该第二面的曲率半径为10mm-50mm；球囊接口，该球囊接口设置在该球囊本体的开口处，用以供填充物通过并进入到该球囊本体中；密封组件，该密封组件设置在该球囊本体和/或该球囊接口处，包括密封体；外导管，该外导管与该球囊接口可拆卸地连接，该填充物经该外导管从球囊接口处进入该球囊本体。
更进一步地，所述保护结构的高度H1为4mm-20mm，该限制结构的高度H2为H1+15mm。
更进一步地，该保护结构包括弧线段，该弧线段的两个端点与该限制结构的最大宽度处的点通过连线构成等腰梯形。
更进一步地，该球囊本体包括至少两层结构，该两层结构的材料选自聚乙烯、聚酰胺、聚酯、聚氨酯、聚乳酸或聚己内酯中的一种或多种的组合。
更进一步地，该球囊本体包括内层、外层以及位于内层以及外层之间的药物层。
更进一步地，该外层由可降解高分子材料组成，和/或该药物层包括至少一种以下药物：双氯酚酸二乙胺、芬太尼及其类似物、埃托啡及其类似物、α2受体激动剂美托咪啶、氟哌利多、依托脒酯、维库溴铵及其类似物、普鲁卡因盐酸盐、丁卡因盐酸盐、利多卡因盐酸盐、抗生素、头孢类消炎药。
更进一步地，本申请还公开了一种肩袖球囊，包括：球囊本体、球囊接口以及密封组件，该球囊本体包括至少两层结构，该两层结构均由聚乙烯组成，该球囊本体包括限制结构以及连接于该限制结构的保护结构，该限制结构的最大宽度大于该保护结构的最大宽度，所述保护结构包括弧线段，所述弧线段的曲率为≤0.21mm -1，所述限制结构包括第一面和第二面，所述第二面的曲率半径为10mm-50mm。该保护结构的高度H1为4mm-20mm。
更进一步地，该密封组件设置在该球囊本体和/或该球囊接口处，包括密 封体，该密封体包括阻止该填充物流出该球囊本体的密封膜，所述密封组件还包括外导管，该外导管与该球囊接口可拆卸地连接，该填充物经该外导管从球囊接口处进入该球囊本体。
更进一步地，该密封体设置在该球囊本体内，该密封组件包括与该密封体可拆卸连接的辅助管，用以将该密封体预定位在该球囊接口处。
更进一步地，该保护结构包括弧线段，该弧线段的两个端点与该限制结构的最大宽度处的点通过连线构成等腰梯形。
本申请所提供的肩袖球囊符合人体肩关节生理结构，自限于肩峰下间隙，能够减少患者异物感、脱位、功能失效等不良事件发生。其中，保护结构用于支撑在人体肩关节肱骨头与肩峰之间的间隙内，实现支撑的作用，同时肩袖损伤患者的肱骨头上移，避免了组织间撞击造成的疼痛，也进而增加了三角肌施力力臂，得以即刻改善患者肩关节功能，限制结构用于与人体肩关节肱骨头至少部分贴合以起到限位的作用，避免假体移位。
本申请所提供的肩袖球囊的限制结构的第一面和第二面均为曲面，以使得所述限制结构与人体肱骨头或大结节全部或部分贴合，如此能够让限制结构发挥最大的限位作用，最大程度上，避免假体移位。
本申请所提供的肩袖球囊的限制结构的边缘呈弧形，此弧形结构能够与肩关节、肩袖顶端生理形状相适应，不会对患者的活动限制，不会损伤周围软组织。
本申请所提供的肩袖球囊的限制结构具有第一容置腔，保护结构具有与第一容置腔相通的第二容置腔，在限制结构与保护结构内注入填充物后，保护结构可贴合肩袖，在肩关节活动过程中避免肩袖与肩峰或其他组织结构撞击，并且可保持肱骨头与肩峰距离，维持肩关节活动力臂长度，减少肌肉负荷；限制结构能够与人体肩关节肱骨头紧密咬合，提高限位能力。限制结构以及保护结构内可注入填充液体、胶体或气体，达到与关节生理结构贴合的目的，能良好的改善肩袖损伤患者的肩关节功能，并且假体的特殊外形适应人体肩关节特殊生理结构，达到更良好的支撑、减少撞击的目的，获得更良好的治疗效果。
本申请所提供的肩袖球囊为减少假体植入后对患者造成可能的异物感，当第一容置腔与所述第二容置腔内均填充有填充物时，限制结构的高度由远离保护结构的一端至与保护结构相连接的一端逐渐增大，也即限制结构设计为外侧较薄，向近头端逐渐增厚，如此可减少活动时限制结构对肱骨头的影响。
本申请所提供的肩袖球囊能有效实现球囊本体的密封性，避免填充液体或凝胶流出球囊，并且结构简洁。
附图说明
图1为人体各解剖面示意图；
图2为本申请一实施例所述的肩袖球囊膨胀后的侧面剖视示意图；
图3为图1所示的肩袖球囊俯视示意图；
图4为图1所示的肩袖球囊后视示意图；
图5为图1所示的肩袖球囊正面示意图；
图6为图1所示的肩袖球囊侧面示意图；
图7为图1所示的肩袖球囊与人体配合示意图；
图8为另一实施例的肩袖球囊侧面示意图；其中，L1为肩袖球囊沿冠状面的长度，L2为肩袖球囊中的保护结构沿冠状面的长度，H1为肩袖球囊中的保护结构沿矢状面的高度，H2为肩袖球囊沿矢状面的高度；
图9为另一实施例的肩袖球囊俯视示意图；其中，L3为肩袖球囊中的保护结构沿水平面的宽度，L4为肩袖球囊中的限制结构沿水平面的宽度；
图10为另一实施例的肩袖球囊俯视示意图；
图11为另一实施例的肩袖球囊俯视示意图；
图12为另一实施例的肩袖球囊的密封结构示意图。
附图标记说明：
10：肩袖球囊；100：限制结构；110：第一容置腔；200：保护结构；210：第二容置腔；300：注入孔；400：注入管；500：单向阀；600：填充物。
具体实施方式
为了便于理解本申请，下面将参照相关附图对本申请进行更全面的描述。附图中给出了本申请的较佳实施例。但是，本申请可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对本申请的公开内容的理解更加透彻全面。
除非另有定义，本文所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本申请。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。
参见图1所示，图1是定义人体各个解剖面的示意图。其中，矢状面101：指从前后方向，将人体或关节分成左、右两部分的纵切面，其中，经过人体正中的矢状面为正中矢状面，该面将人体分成左右相等的两部分；冠状面102：指从左右方向，将人体或关节分为前后两部分的纵切面，该切面与矢状面垂直；水平面103：也称横切面，是与地平面平行并将人体或关节分为上、下两部分的平面，该平面与冠状面和矢状面相互垂直。
参见图2所示，本申请一实施例提供了一种肩袖球囊10，其包括限制结构100以及连接于限制结构100的保护结构200。限制结构100沿冠状面具有弧度，或者限制结构100与保护结构200沿冠状面具有夹角。优先地，限制结构100沿冠状面以及矢状面均具有弧度，限制结构100的内表面的曲率半径为10至50mm。具体地，限制结构100具有第一面和第二面，限制结构100的第一面和第二面均为曲面，例如，第二面为内表面(如图2所示朝下的表面)。参见图7所示，第二面用于全部或部分贴合肱骨头和/或大结节，该第二面从肱骨头处延伸至少部分覆盖大结节。发明人发现，与仅覆盖肱骨头相比，限制结构100的第二面部分或全部覆盖大结节可以避免在手臂进行外展内旋等活动时发生所述假体移位脱离，同时可将肩袖肌腱撕裂的伤口保护在所述假体限制结构内侧，进一步避免了撕裂伤口与骨骼撞击造成患者剧烈疼痛。因此，能够让限制结构100发挥最佳的限位作用，最大程度上，避免肩袖球 囊移位。优选地，限制结构100可呈半碗状结构，半碗型结构的限制结构100能贴合肱骨头，起到维持整个肩袖球囊的位置的功能。可理解，在其他实施例中，限制结构100的结构和形状不限于上面所述，限制结构100的结构和形状还可以是半盆状、半钵状结构等。
参见图7所示，保护结构200用于支撑在人体肩关节的肱骨头与肩峰之间的间隙内以支撑肩峰。
进一步地，参见图4及图5所示，限制结构100的边缘沿矢状面呈弧形，限制结构100的边缘平滑，此弧形结构能够与肩关节、肩袖顶端生理形状相适应，减少肩关节活动时限制结构100的外边缘对肌肉组织的损伤。
进一步地，参见图2及图3所示，限制结构100的最大宽度大于保护结构200的最大宽度，优选地，参见图9所示，限制结构100的与保护结构200的过渡位置处的宽度L4大于保护结构200的宽度L3，如此设置，可提高限制结构100与人体肩关节肱骨头和大结节的贴合性，并配合肩峰下滑囊皱襞反折处限制保护结构200以及整个肩袖球囊发生位移。优选地，限制结构100和/或保护结构200能够形变，该形变可以是压缩后的恢复性形变、填充有填充物后的膨胀性形变，或者其他形式的形变。限制结构100和/或保护结构200能够形变以达到与人体肩关节肱骨头、人体肩关节肱骨头与肩峰之间的间隙的配合，适应人体肩关节特殊生理结构，达到更良好的支撑、减少撞击目的，获得更良好的治疗效果。在填充过程中，限制结构100和/或保护结构200通过形变如压缩后的自膨胀或者填充后膨胀，自适应肩关节生理结构，可与人体肱骨头相贴合，同时配合肩关节滑囊皱襞反折的生理结构可限制肩袖球囊在肩关节上的内外侧位移，自限于肩峰下间隙，避免脱位，另外，形变带来的自适应功能使得限制结构100和保护结构200不会对患者的活动造成限制，也不会损伤周围软组织。
在另一个实施例中，参见图8所示，H1为肩袖球囊10中的保护结构200沿矢状面的尺寸也即保护结构200的高度，其优选为4-20mm。根据密闭腔体受压的弹性力学原理，P＝σ·h/r，其中P为腔体可承受的最大压强，为腔体外壳材料环向应力强度，h为腔体外壳壁厚，r为腔体最小处半径。在本申请 所述的肩关节假体植入的肩峰下间隙位置，肩峰与肱骨头之间相互挤压的最大压强约为88KPa(即P＝88KPa)，所述肩关节假体保护结构200的高度H1为4-20mm(即为保护结构腔体最小处半径r＝2～10mm)，则σ·h的取值范围是176～880KPa·mm，该值的意义是指导所述肩关节假体材料的选择以及壁厚的具体设计，例如当所述肩关节假体壁厚h为0.1mm时，至少可选取假体材料强度σ在1760～8800KPa范围的材料，实际上，如聚酰胺、聚酯、聚乙烯、聚乳酸、聚氨酯、聚己内酯等常用不可降解与可降解医用材料可满足该要求。所以，H1优选为4-20mm，可实现所述肩关节假体在常用医用材料、常规制造精度的条件下，即能够实现所述保护结构支撑肱骨头与肩峰的功能。
H2为肩袖球囊10沿矢状面的高度，其优选为9-34mm。更优选地，限制结构100沿矢状面的直线尺寸也即限制结构100的高度H2为H1+15mm，如此设置能实现限制结构100覆盖肱骨头大结节又可避免因限制结构100尺寸过大而妨碍肩袖肌肉群活动。
参见图8所示，L1为肩袖球囊10沿冠状面的长度，其优选为30-70mm。L2为肩袖球囊10中的保护结构200沿冠状面的长度，其优选为10-40mm。参见图9所示，L3为肩袖球囊10中的保护结构200沿水平面的宽度，其优选为15-60mm。L4为肩袖球囊10中的限制结构100沿水平面的宽度，其优选为20-70mm。上述设置能够实现保护结构200分隔肩峰与肱骨头作用，限制结构100包覆肱骨头及大结节从而防止脱位的作用。
上述不同尺寸的肩袖球囊10适用于不同直径大小的肱骨头。例如，适用于肱骨头直径5cm的情况时，优选H1为10-12mm，H2为25-27mm，L1为55-65mm，L2为25-35mm，L3为30-50mm，L4为55-60mm，限制结构100的内表面的曲率半径为25-30mm。
参见图8所示，限制结构100的高度H2由远离保护结构200的一端至与保护结构200相连接的一端逐渐增大。
图10是该肩关节假体的另一种实施方式的俯视图。如图10所示，限制结构100在其最大宽度处的端点包括D点和C点，保护结构200包括弧段，所述弧段的端点构成A点和B点。所述A、B、C、D点的连线构成等腰梯形， 该结构可以提升保护结构AB边与CD边之间水平力值的传递，由于在手臂外展抬升时，肱骨头向肩关节窝内侧转动，对保护结构形成从CD向AB方向的水平作用力，造成保护结构之间的水平挤压，而通过大角度梯形轮廓的设计，降低力在两侧边沿间传递的损耗，所以能减少保护结构在手臂外展动态过程中发生内应变导致变形褶皱。更优选的，弧段AB的曲率≤0.21mm -1，CD段弧线的曲率≤0.15mm -1。
图9中的A点和D点之间可以是一段或多段直线段连接，也可以是一段或多段弧线段连接，或者直线段与弧线段连接。如图11所示，A点和C点之间包括弧段AB和弧段BC，D点和F点之间包括弧段DE和弧段EF，其中AB段与EF段弧线的曲率优选≤0.3mm -1，BC段与DE段弧线的曲率优选为≤0.15mm -1。
限制结构100具有第一容置腔110，保护结构200具有与第一容置腔110相通的第二容置腔210，第一容置腔110与第二容置腔210内均用于供填充物600填充。在填充过程中，限制结构100、保护结构200在填充有填充物600之后，保护结构200可贴合肩袖，在肩关节活动过程中避免肩袖与肩峰或其他组织结构撞击，并且可保持肱骨头与肩峰距离，维持肩关节活动力臂长度，减少肌肉负荷；限制结构100能够与人体肩关节肱骨头紧密咬合，提高限位能力。
优选地，限制结构100和保护结构200可以是球囊，也可以是海绵样元件，或者是不可膨胀的结构。
当限制结构100具有第一容置腔110、保护结构200具有第二容置腔210时，优选地，限制结构100的最大高度由远离保护结构200的一端至与保护结构200相连接的一端逐渐增大。限制结构100的最小高度为填充填充物之前的高度或者压缩限制结构100后的高度；限制结构100的最大高度为填充填充物之后的高度或者压缩限制结构100后自恢复状态时的高度。保护结构200的最小高度为填充填充物之前的高度或者压缩保护结构200后的高度；保护结构200的最大高度为填充填充物之后的高度或者压缩保护结构200后自恢复状态时的高度。
参见图2所示，当第一容置腔110与第二容置腔210内均填充填充物600时，限制结构100的高度由远离保护结构200的一端至与保护结构200相连接的一端逐渐增大。为减少肩袖球囊10植入后对患者造成可能的异物感，设置了第一容置腔110与第二容置腔210内均填充填充物600时，限制结构100的高度由远离保护结构200的一端至与保护结构200相连接的一端逐渐增大，也即限制结构100设计为外侧较薄，向近头端逐渐增厚，如此可减少活动时限制结构100对肱骨头的影响。
另外，保护结构200的囊壁可针对不同使用需求进行特异优化，如运动需求较多者，为增加使用年限可适度增厚。
进一步地，当第一容置腔110与第二容置腔210内均填充填充物600时，限制结构100与保护结构200相连接的一端的高度与保护结构200的高度一致，以减少肩关节活动时肱骨头不适感。
保护结构200的其中一表面呈曲面状以使得该表面与肩袖基本贴合。具体地，保护结构200在横轴平面上为向下弯曲的弧形结构，此弧形结构与肩关节、肩袖顶端生理形状相适应，在注入填充物600后，保护结构200可贴合肩袖，并且在肩关节活动过程中避免肩袖与肩峰或其他组织结构撞击，并且可保持肱骨头与肩峰的距离，维持肩关节活动的力臂长度，减少肌肉负荷。
进一步地，参见图3及图5所示，限制结构100和/或保护结构200上设置有注入孔300，注入孔300连通于第一容置腔110和第二容置腔210，注入孔300内设置有单向阀500，单向阀500可避免经注入孔300注入的填充物600反向流出。
进一步地，参见图2及图6所示，上述肩袖球囊10还包括设置在第一容置腔110内和/或第二容置腔210内且连通于注入孔300的注入管400，注入管400朝外的管口与限制结构100或者保护结构200的外表面齐平，单向阀500设置于注入管400内。
进一步地，参见图6所示，注入管400连通注入孔300的一端的管径较其朝内的一端小。
优选地，注入管400具有柔性，有效地解决了传统技术中存在的在植入 后特定动作下可能造成患者不适、异物感的问题。
进一步地，参见图6所示，限制结构100与保护结构200连接呈一体式结构，限制结构100与保护结构200一体式结构的设计，方便开模和加工制作，制作成本低。
进一步地，限制结构100、保护结构200以及注入管400均由不可降解材料制成。本申请肩袖球囊10的限制结构100与保护结构200均由不可降解材料制成，解决了传统技术中的植入体在短期内存在降解失效的问题，避免了肩袖球囊10破裂，使其在37°温度下可长期有效工作，有效防止变质的填充物内释出对患部造成的进一步损伤。
进一步地，限制结构100的制备材料包括但不限于硅胶、聚氨酯、橡胶、聚酰胺、聚酯、聚烯烃中的一种或多种。保护结构200的制备材料包括但不限于硅胶、聚氨酯、橡胶、聚酰胺、聚酯、聚烯烃中的一种或多种。注入管400的制备材料包括但不限于硅胶、聚氨酯、橡胶、聚酰胺、聚酯、聚烯烃中的一种或多种。在一种优选实施例中，为了使肩袖球囊为肩峰提供长期的支撑力，优选地该球囊由双层球囊制成，并且双层球囊的材料均为聚乙烯。发明人发现，置于肩关节腔内的球囊需要同时面对骨刺和适度柔顺性问题。双层聚乙烯肩袖球囊可以有效提升抗穿刺能力并能在球囊充盈后有效地填充人体关节腔从而实现自适应。
进一步地，参见图2所示，上述肩袖球囊10还包括填充物600，填充物600填充在第一容置腔110与第二容置腔210内。优选地，填充物600包括液体和/或胶体。例如填充物600为水、硅胶或凝胶等。
图12所示的是本申请所公开的肩袖球囊的密封组件的剖面示意图，其中，密封组件包括内置在球囊本体7之中的密封体9和与密封体9可拆卸连接的辅助管11，通过辅助管11能够将密封体9定位并覆盖在球囊接口8上。填充开始前，将辅助管11预先连接在密封体9上，之后再将外导管1连接在球囊接口8上。填充开始时，推动辅助管11从而推动密封体9打开球囊本体7的腔体，通过外导管1和辅助管11之间的环状间隙实现对球囊本体7的填充，在填充完毕后，密封体9受到球囊本体7内部填充物的压力贴合在其开口处， 此时卸下外导管1和辅助管11并从生物体内撤出，能够同时实现球囊本体7的密封。辅助管11或密封体9可以设计薄弱区12，当操作者向该辅助管11施加拉力时，密封体9受到球囊本体7内部的压力贴合在其开口处，并且薄弱区12断裂。在另一种可选择的方案中，密封体9的一端与辅助管11之间可以设置相互配合的螺纹，或密封体9的一端可以与辅助管11过盈配合。
本申请提供一种植入假体，该植入假体包括至少两层结构，内层为密封结构，药物层位于内层的全部或部分表面。内层可容纳液体或半固体后充盈。该植入假体还可以包括外层，药物层位于内层与外层之间，药物层可以为液态药物也可以为固态药物。外层可以为降解材料也可以为多孔材料。
在一种较佳实施例中，本申请所提供的肩袖球囊的表面或内部可以载药。
在一种较佳实施例中，该载药肩袖球囊可以实现药物即时释放，该肩袖球囊植入人体、扩张后，球囊外表面与人体组织、人体体液接触，从而即时释放球囊外表面的药物。在球囊外表面可通过洗脱方式装载药物涂层。进一步地，可在球囊外表面通过预制凹槽，增大药物装载量。球囊表面可装载促进损伤肌腱恢复或止疼镇痛或消炎等药物，以便促进撕裂的肌腱生长恢复或减轻患者疼痛或消除炎症等效果。
所述球囊可选用洗脱式，或通过囊壁外层带有凹槽的结构装载药物。
所述球囊装载的药物可选用双氯酚酸二乙胺、芬太尼及其类似物、埃托啡及其类似物、α2受体激动剂美托咪啶、氟哌利多、依托脒酯、维库溴铵及其类似物、普鲁卡因盐酸盐、丁卡因盐酸盐、利多卡因盐酸盐、抗生素、头孢类消炎药以及其他具备促进肌腱修复或止疼镇痛或消除炎症效果的药物中的一种或多种组合。
所述球囊可选用气体、液体或凝胶进行充盈扩张，可根据医生需求确定充盈成分。
所述球囊充盈物质可选用药物溶液或凝胶，球囊材料选用生物可降解型的医用高分子材料。当球囊降解后，球囊内部药物可被释放至病变部位。
在一种较佳实施例中，该载药肩袖球囊可以实现定时药物释放。该肩袖球囊为双层两腔球囊结构，外腔用于存储药物，内腔用于充盈扩张球囊。球 囊外层材料选用生物可降解医用高分子材料，当球囊外层囊壁降解后，会使双层两腔结构球囊的外腔药物与人体组织、人体体液接触，从而释放药物起到治疗作用。可通过调整球囊外层材料的聚合物成分、聚合物链段结构、分子量、结晶度、囊壁厚度，实现对球囊外层降解时间的定量调控。当球囊植入时间达到临床需求时间后，球囊外层囊壁完成降解，释放药物，形成时间定点释放。球囊内层材料可选用可降解生物医用高分子材料，也可选用非可降解医用高分子材料。
所述球囊可选用气体、液体或凝胶充盈内腔、扩张球囊，可根据医生需求确定充盈成分。当球囊内层采用生物可降解性的医用高分子材料时，内腔也可选用药物溶液或凝胶进行充盈。
所述球囊外层囊壁的外表面可不载药，也可选用上述即时释放型载药球囊结构，通过在外层囊壁外表面进行洗脱或囊壁外层增加带有凹槽的结构装载药物。
在一种较佳实施例中，该载药肩袖球囊可以实现周期性药物释放。在上述时间定点释放型载药球囊结构基础上，提供一种囊体内部载药的多层多腔球囊结构，最内部的腔体为充盈腔，其他腔体为载药腔。每个载药腔的外层材料选用生物可降解医用高分子材料，当载药腔外层囊壁降解后，会使载药腔中的药物与人体组织、人体体液接触，从而释放药物。球囊最外层囊壁最早接触人体体液，所以载药腔外层囊壁的降解顺序为从外到内逐层降解，多个载药腔内的药物也即周期性地随外层降解后接触人体组织与体液，从而释放。各个载药腔内可根据治疗需求，装载相同药物或者装载不同种类、不同用途药物。可通过调整球囊载药腔外层材料的聚合物成分、聚合物链段结构、分子量、结晶度、囊壁厚度，实现对载药腔外层降解时间的定量调控。球囊最内层(即充盈腔的外层)材料可选用可降解生物医用高分子材料，也可选用非可降解医用高分子材料。
所述球囊为多层囊壁、多个腔体结构，内腔用于充盈扩张球囊，其他腔体用于载药。多层囊壁可通过热熔焊接方式在球囊管段处或邻近位置实现连接，密封载药腔。当球囊最内层选用非可降解材料时，多层囊壁还可通过胶 水进行连接，从而密封载药的外腔。
所述球囊载药腔外层选用生物可降解医用高分子材料，最内层可选用不可降解材料或生物可降解的医用高分子材料。
在一种较佳实施例中，该载药肩袖球囊可以实现长期性持续性药物释放。球囊外形与不含药球囊相似，采用单腔结构，当球囊被植入人体后，向腔内注入药物溶液或药物凝胶，充盈扩张球囊。球囊囊壁采用多孔高分子膜，受球囊内外药物组分浓度差以及球囊所受骨骼、人体组织压力驱动，所述球囊会以一定速率将球囊内的药物通过孔隙通道持续性释放到球囊外。根据适用的药物分子尺寸，球囊所采用多孔材料的孔径尺寸可预制成相应的微孔(孔径<2nm)或介孔(孔径2～50nm)。并且，可通过调整球囊囊壁多孔膜的孔隙率、孔径尺寸、曲折因子、厚度等结构特征参数，定量调控药物释放速率与释放时间。该球囊结构相比其他结构，具有更大载药量、更长释放药物时间的优点。本申请还提供一种海绵型的多孔载药植入物结构，在海绵型结构中吸附充满药物溶液。在植入人体后，药物溶液在骨骼与人体组织的压力作用下，得到释放。该海绵型植入物可与球囊结构相结合形成复合结构，提升整个结构的支撑力，植入物内部为球囊，外部为海绵状多孔载药结构。
所述海绵型多孔结构材料采用生物相容性的医用高分子弹性材料，可以选用橡胶类热固性弹性体，以及聚酰胺、聚氨酯、聚烯烃、苯乙烯类等热塑性弹性体。所述复合结构中球囊材料采用生物相容性医用高分子，可以选用聚酯类、聚酰胺、聚氯乙烯、尼龙弹性体、聚氨酯等。
该肩袖球囊可以用于其他人体的组织腔中，如脊椎、胃等。本领域普通技术人员可以根据使用环境的需要，选择上述技术特征进行任意组合。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本专利申请范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若 干变形和改进，这些都属于本申请的保护范围。因此，本专利申请的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种肩袖球囊，其特征在于，包括：
    球囊本体，所述球囊本体包括限制结构以及连接于所述限制结构的保护结构，所述限制结构的最大宽度大于所述保护结构的最大宽度，所述保护结构包括弧线段，所述弧线段的曲率为≤0.21mm -1，所述限制结构包括第一面和第二面，所述第二面的曲率半径为10mm-50mm；
    球囊接口，所述球囊接口设置在所述球囊本体的开口处，用以供填充物通过并进入到所述球囊本体中；
    密封组件，所述密封组件设置在所述球囊本体和/或所述球囊接口处，包括密封体；
    外导管，所述外导管与所述球囊接口可拆卸地连接，所述填充物经所述外导管从所述球囊接口处进入所述球囊本体。
  2. 如权利要求1所述的肩袖球囊，其特征在于，所述保护结构的高度H1为4mm-20mm，和/或所述限制结构的高度H2为H1+15mm。
  3. 如权利要求1所述的肩袖球囊，其特征在于，所述弧线段的两个端点与所述限制结构的最大宽度处的点通过连线构成等腰梯形。
  4. 如权利要求1所述的肩袖球囊，其特征在于，所述球囊本体包括至少两层结构，所述两层结构的材料选自聚乙烯、聚酰胺、聚酯、聚氨酯、聚乳酸或聚己内酯中的一种或多种的组合。
  5. 如权利要求4所述的肩袖球囊，其特征在于，所述球囊本体包括内层、外层以及位于所述内层以及所述外层之间的药物层。
  6. 如权利要求1所述的肩袖球囊，其特征在于，所述密封体与所述球囊接口过盈配合。
  7. 一种肩袖球囊，其特征在于，包括：球囊本体、球囊接口以及密封组件，所述球囊本体包括至少两层结构，所述两层结构均由聚乙烯组成，所述球囊本体包括限制结构以及连接于所述限制结构的保护结构，所述限制结构的最大宽度大于所述保护结构的最大宽度，所述保护结构包括弧线段，所述 弧线段的曲率为≤0.21mm -1，所述限制结构包括第一面和第二面，所述第二面的曲率半径为10mm-50mm。
  8. 如权利要求7所述的肩袖球囊，其特征在于，所述球囊接口设置在所述球囊本体的开口处，用以供填充物通过并进入到所述球囊本体中，所述密封组件设置在所述球囊本体和/或所述球囊接口处且包括密封体，所述密封体包括阻止所述填充物流出所述球囊本体的密封膜，所述密封组件还包括外导管，所述外导管与所述球囊接口可拆卸地连接，所述填充物经所述外导管从所述球囊接口处进入所述球囊本体。
  9. 如权利要求8所述的肩袖球囊，其特征在于，所述密封体设置在所述球囊本体内，所述密封组件包括与所述密封体可拆卸连接的辅助管，用以将所述密封体预定位在所述球囊接口处。
  10. 如权利要求7所述的肩袖球囊，其特征在于，所述保护结构包括弧线段，所述弧线段的两个端点与所述限制结构的最大宽度处的点通过连线构成等腰梯形。
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