WO2016008062A1 - 一种肱骨近端固定装置 - Google Patents

一种肱骨近端固定装置 Download PDF

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Publication number
WO2016008062A1
WO2016008062A1 PCT/CN2014/000681 CN2014000681W WO2016008062A1 WO 2016008062 A1 WO2016008062 A1 WO 2016008062A1 CN 2014000681 W CN2014000681 W CN 2014000681W WO 2016008062 A1 WO2016008062 A1 WO 2016008062A1
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WO
WIPO (PCT)
Prior art keywords
nail
contact portion
fixing device
holder
contact
Prior art date
Application number
PCT/CN2014/000681
Other languages
English (en)
French (fr)
Inventor
唐佩福
陈华
Original Assignee
唐佩福
陈华
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 唐佩福, 陈华 filed Critical 唐佩福
Priority to JP2017502657A priority Critical patent/JP6464367B2/ja
Priority to US15/325,306 priority patent/US20170164986A1/en
Priority to EP14897803.4A priority patent/EP3170465B1/en
Priority to PCT/CN2014/000681 priority patent/WO2016008062A1/zh
Publication of WO2016008062A1 publication Critical patent/WO2016008062A1/zh

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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
    • A61F2/30—Joints
    • A61F2/40—Joints for shoulders
    • A61F2/4059—Humeral shafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
    • A61B17/725—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with locking pins or screws of special form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3082—Grooves
    • 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
    • A61F2/4014—Humeral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic humeral shafts
    • A61F2002/4018—Heads or epiphyseal parts of humerus
    • 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
    • A61F2/4014—Humeral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic humeral shafts
    • A61F2002/4051—Connections of heads directly to shafts
    • 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
    • A61F2/4059—Humeral shafts
    • A61F2002/4062—Proximal or metaphyseal parts of shafts
    • 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
    • A61F2/4059—Humeral shafts
    • A61F2002/4077—Distal or diaphyseal parts of shafts

Definitions

  • the invention belongs to the field of medical instruments, and in particular relates to a proximal humeral fixation device. Background technique
  • Proximal humeral fractures refer to fractures above the greater tibia of the humerus, which account for 4% to 5% of total body fractures and 26% of shoulder fractures. Because of the frequent fractures of the proximal humerus, it is important for its treatment, fixation, and postoperative recovery to avoid leaving patients with worries. In addition, proximal humeral fractures are common in middle-aged and elderly people. Because middle-aged and elderly people often have severe osteoporosis and are prone to comminuted fractures, the proximal humerus lacks effective medial support. In the fixation of the humeral fracture site in this group of people, there are often problems such as insufficient screw holding force and lack of effective medial mechanical support. In the long run, patients after treatment often have humeral head varus and screw cut humeral head. The phenomenon of entering the joints seriously affects the shoulder function of the patient, and therefore, it is very difficult to treat.
  • the main fracture of the humerus is treated by locking plate, semi-shoulder replacement and intramedullary nailing.
  • the locking plate has improved the fixation of the fracture site by means of the locking screw technique and the cross-pinning technique, but still lacks effective medial support and there is a risk of the screw entering the joint.
  • Half-shoulder replacement is easy to cause poor healing or absorption of the large tibial tuberosity, which leads to the loss of the effective arm of the rotator cuff function, which has a great influence on the flexion and abduction function of the shoulder joint.
  • intramedullary nail fixation can effectively solve the problem of medial support, the fixation of the humeral head is limited.
  • the lack of stable fixation for severe comminuted fractures does not provide effective mechanical support for the early functional exercise of the shoulder joint.
  • the implantation of the intramedullary nail requires a drill point, and the intramedullary nail and the internal structure of the medullary cavity are obviously mismatched, which may affect the intramedullary blood supply.
  • the present invention provides a proximal fixation of the humerus. Device.
  • a proximal humeral fixation device comprising: a fixer, a main nail, an anti-rotation nail, and a locking nail;
  • the fixator is disposed in the medullary cavity at the proximal end of the tibia to match the proximal medullary cavity of the humerus;
  • the upper end portion of the holder includes a first contact portion and a second contact portion; the first contact portion is in contact with the humeral head, and the first contact portion is a planar structure;
  • the second contact portion is in contact with the large tibial tuberosity, the second contact portion is in a bulging shape; the distal end of the lower end portion of the holder is in a bullet shape, and the lower end portion of the holder is not in contact with the medullary cavity ;
  • the main nail is used for fixing the humeral head and the first contact portion
  • the head of the anti-rotation screw enters the humeral head, and the tail portion is fixedly connected with the fixing device; the locking nail is disposed at a lower end portion of the holder for fixing the fixing device to the humeral shaft .
  • the surface of the holder is provided with a groove.
  • a side hole is provided in the second contact portion.
  • the first contact portion is disposed at 45 to 50 degrees from the medullary cavity.
  • the anti-rotation nails are set to three.
  • the tail of the anti-rotation screw is fixedly disposed with the fixing nut by a nut.
  • the main nail, the anti-rotation nail, and/or the locking nail are positioned using a guide.
  • the material for manufacturing the holder comprises: a metal material or an absorbable material.
  • the metal material comprises: a titanium alloy, a stainless steel, a tantalum, and/or a memory alloy.
  • the holder has a length of 3 cm to 20 cm.
  • the proximal humeral fixation device provided by the invention is placed in the proximal medullary cavity of the humerus, and the effective support for the humeral head is realized.
  • the upper end portion of the fixer has a first contact portion of a planar structure and a second contact portion of a bulging shape; the two portions can respectively match the structure of the humeral head and the large nodule of the tibia, and the proximal humerus fracture The part is effectively supported.
  • the distal end of the lower end of the fixator extends in a bullet shape to the distal end without reaming, which can reduce the damage to the blood supply of the medullary cavity.
  • the combination of the main nail, the anti-rotation nail and the locking nail and the anchor can strengthen the fixed support of the proximal humerus fracture site and prevent the fixator from shifting and slipping.
  • the fixation device has strong fixation force and no risk of screw entering the joint, and does not cause incomplete healing of the humeral large nodules, and can provide effective mechanical support for early functional exercise of the shoulder joint.
  • FIG. 1 is a schematic structural view showing a specific embodiment of a proximal humeral fixation device according to the present invention
  • FIG. 2 is a top plan view of a first contact portion of a proximal humeral fixation device in accordance with the present invention.
  • the same or similar reference numerals in the drawings denote the same or similar components.
  • FIG. 1 there is shown a block diagram of a particular embodiment of a proximal humeral fixation device in accordance with the present invention.
  • the fixing device comprises: a holder 1, a main nail 2, an anti-rotation nail 3, and a locking nail 4.
  • the fixator 1 When in use, The fixator 1 is placed in the medullary cavity at the proximal end of the tibia to match the proximal medullary cavity of the tibia. In order to reduce damage to the blood supply to the medullary cavity, a groove is provided on the surface of the holder 1.
  • the upper end portion of the holder 1 includes a first contact portion 11 and a second contact portion 12; the first contact portion 11 is in contact with the humeral head for supporting the humeral head.
  • the first contact portion 11 has a planar structure to have a larger contact area with the humeral head.
  • the preferred first contact portion 11 is an elliptical plane. According to the position of the humeral head on the tibia and the physiological structure relationship between the humeral head and the medullary cavity, the first contact portion 11 is placed at an angle with the medullary cavity to optimize the supporting force. Preferably, the angle is 45° to 50°, for example: 45°, 48° or 50°.
  • the second contact portion 12 is in contact with the large tibial tuberosity, and the second contact portion 12 has a raised shape for matching with the structure of the large tibial tuberosity.
  • a side hole is provided in the second contact portion 12, and when the suture is required to be fixed, the side hole can be realized.
  • the distal end of the lower end of the holder 1 is bullet-shaped and does not contact the medullary cavity.
  • the streamlined design reduces sharp contact with the medullary cavity, avoids excessive stress concentration, and reduces damage to the bone marrow in the medullary cavity.
  • the material for manufacturing the holder 1 comprises: a metal material or an absorbable material.
  • metal materials include, but are not limited to: titanium alloy, stainless steel, tantalum and/or memory alloy.
  • the fixator 1 is implanted in vitro, and after rewarming at body temperature, the proximal medullary cavity of the tibia is filled to support the humeral head.
  • the length of the fixer 1 is different according to the height of the user, the length of the bone, the state of the tibia, and the degree of fracture, the degree of osteoporosis, etc.
  • the length of the fixer 1 is 3 cm to 20 cm. , for example: 3cm, 10cm or 20cm.
  • the length of the holder 1 is preferably 8 cm in view of the physiological condition of the usual patient.
  • the main nail 2 is used to fix the humeral head and the first contact portion 11.
  • the pull bone is pulled onto the first contact portion 11 of the holder 1.
  • the head of the anti-rotation nail 3 enters the humeral head, and its tail is fixedly connected to the holder 1.
  • the tail portion of the anti-rotation screw 3 is fixedly disposed with the holder 1 by a nut.
  • the anti-rotation nail 3 functions to fix the humeral head so that the humeral head does not rotate on the first contact portion 11 of the holder 1. Since the stability of the triangular structure is the highest, the anti-rotation nails 3 are arranged in three, and the arrangement thereof is preferably a triangle. Referring to Fig. 2, more preferably, the main nail 2 is placed at the center of the triangle formed by the anti-rotation nail 3.
  • the anti-rotation nail 3 has no threads, allowing the humeral head to partially absorb. When the humeral head is partially absorbed, the contact of the humeral head with the first contact portion 11 will be more tight, and the anchoring effect of the anchor for the fracture portion is better. Defense The length of the screw 3 varies depending on the condition of the patient, and it is preferable not to penetrate the joint.
  • the locking pin 4 is disposed at a lower end of the holder 1 for fixedly connecting the holder 1 with the humeral shaft.
  • the anchor 1 In order to reduce the damage to the blood supply of the medullary cavity, and at the same time, the anchor 1 is brought into contact with the medullary cavity to achieve stable fixation, and the proximal end of the anchor 1 has a triangular cross section. It is to be noted that the proximal end of the holder 1 means: a portion between the locking nail 4 and the first contact portion 11 near the upper end of the holder 1.
  • the primary staples 2, the anti-rotation spikes 3 and/or the locking staples 4 are each positioned with a guide.
  • the fixation device provided by the present invention can also be used in combination with an extramedullary fixation device to further enhance the fixation effect.
  • the patient should be in a beach chair position or a supine position, and a conventional sterile disinfection towel should be placed; after that, the deltoid pectoralis major intermuscular groove approach reveals the patient's tibia near End fracture site.
  • the insertion of the fixture is initiated.
  • the angle is between 130° and 150°; then, the large and small nodular fracture block is opened, and the iliac crest is pulled outward to expose the proximal medullary cavity of the humerus; after that, the elbow joint is held forward and the fixation device is tilted backward by 20°.
  • the fixing device provided by the invention directly enters the medullary cavity through the size of the fracture, and matches the proximal medullary cavity of the humerus, the first contact portion 11 supports the humeral head at an angle, and the ridge support of the second contact portion 12 Large nodules; fixation and anti-rotation of the humeral head by the main nail 2 and the anti-rotation screw 3.
  • the transmission of the bearing force of the main nail 2 allows the main nail 2 to be retracted to achieve sliding pressure.
  • the holder 1 has a side hole that allows new bone to grow in.
  • the length of the anti-rotation screw 3 is suitable. After the bone is absorbed, the anti-rotation screw 3 does not penetrate the shoulder joint, and the shoulder is closed. The knot causes damage.
  • the fixture 1 is matched to the medullary cavity to achieve medial support of the proximal tibia.
  • the fixing device of the invention can realize the mechanical support of the connection of the humeral head and the tibia, and the bone tissue wrapping and fixing device 1 is healed, and the effect of reinforcing steel and cement perfusion is achieved, and the fixing force is strong.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

一种肱骨近端固定装置，该固定装置包括：固定器（1）、主钉（2）、防旋钉（3）、锁定钉（4）；固定器（1）设置于肱骨近端的髓腔内，与肱骨近端髓腔相匹配；固定器（1）的上端部包括第一接触部（11）和第二接触部（12）；所述第一接触部（11）与肱骨头接触，第一接触部（11）为平面结构；所述第二接触部（12）与肱骨大结节接触，第二接触部（12）呈隆起形状；所述固定器（1）的下端部（13）的远端呈子弹形，固定器（1）的下端部（13）不与髓腔相接触；主钉（2）用于固定所述肱骨头与所述第一接触部（11）；所述防旋钉（3）的头部进入肱骨头内，其尾部与所述固定器（1）固定连接；所述锁定钉（4）设置于所述固定器（1）的下端部（13），用于将所述固定器（1）与肱骨干进行固定连接。该固定装置对于肱骨近端严重粉碎性骨折合并或不合并肩关节脱位，固定治疗效果好、手术风险小。

Description

一种肱骨近端固定装置 技术领域
本发明属于医疗器械领域， 具体地说涉及一种肱骨近端固定装置。 背景技术
肱骨近端骨折是指肱骨大结节以上部位的骨折， 其占全身骨折的 4%~5%， 占肩部骨折的 26%。 由于肱骨近端骨折多发， 因此对于其的治疗、 固定、 以及 患者术后恢复非常重要， 以避免为患者留下隐忧。 此外， 肱骨近端骨折常见于 中老年人， 由于中老年人通常都合并有严重的骨质疏松， 容易粉碎性骨折， 因 此肱骨近端缺乏有效的内侧支撑。 在对这类人群的肱骨骨折部位进行固定时， 经常碰到螺钉把持力不足、 缺乏有效的内侧力学支撑等问题； 从长远看， 治疗 后的患者经常出现肱骨头内翻及螺钉切出肱骨头进入关节的现象， 严重影响患 者的肩关节功能， 因此， 治疗起来非常棘手。
目前， 要通过锁定钢板、 半肩置换和髓内钉固定等手段治疗肱骨近端骨折 主。
锁定钢板通过锁定螺钉技术、 交叉销定技术对骨折部位的固定效果有所改 善， 但是仍然缺乏有效的内侧支撑， 而且有螺钉进入关节的风险。 半肩置换易 造成肱骨大结节愈合不良或吸收， 这会导致失去肩袖功能有效的力臂， 对肩关 节屈曲和外展功能影响比较大。 髓内钉固定虽然可有效解决内侧支撑问题， 但 是螺钉对肱骨头的固定是有限的， 对于严重的粉碎性骨折缺乏稳定的固定， 不 能提供肩关节早期功能锻炼的有效力学支撑。 此外髓内钉的植入需要钻制造入 点， 且髓内钉与髓腔的内部结构明显不匹配， 会对髓内血运造成影响。
因此， 虽然现有技术对于肱骨近端骨折后的固定治疗有多种解决方案， 但 是固定效果欠佳， 尤其是对于粉碎性骨折的发生无法进行强有力的内侧支撑， 且不利于患者的术后恢复。 发明内容
为了解决现有技术中对肱骨近端骨折内侧支撑有限、 对于粉碎性骨折治疗 效果不佳以及不利于肩关节恢复功能等缺陷， 本发明提供了一种肱骨近端固定 装置。
根据本发明的一个方面， 提供一种肱骨近端固定装置， 所述固定装置包括： 固定器、 主钉、 防旋钉、 锁定钉；
所述固定器设置于肱骨近端的髓腔内， 与肱骨近端髓腔相匹配；
所述固定器的上端部包括第一接触部和第二接触部； 所述第一接触部与肱 骨头接触， 所述第一接触部为平面结构；
所述第二接触部与肱骨大结节接触， 所述第二接触部呈隆起形状； 所述固定器的下端部的远端呈子弹形， 所述固定器的下端部不与髓腔相接 触；
所述主钉用于固定所述肱骨头与所述第一接触部；
所述防旋钉的头部进入肱骨头内， 其尾部与所述固定器固定连接； 所迷锁定钉设置于所述固定器的下端部， 用于将所述固定器与肱骨干进行 固定连接。
根据本发明的一个具体实施方式， 所述固定器表面设置有凹槽。
根据本发明的另一个具体实施方式， 在所述第二接触部上设置有侧孔。 根据本发明的又一个具体实施方式，所述第一接触部与髓腔呈 45° ~50° 设 置。
根据本发明的又一个具体实施方式， 所述防旋钉设置为 3个。
根据本发明的又一个具体实施方式， 所述防旋釘的尾部采用螺帽与所述固 定器进行固定设置。
根据本发明的又一个具体实施方式， 所述主钉、 所述防旋钉和 /或所述锁定 钉采用导向器进行定位设置。
根据本发明的又一个具体实施方式， 制造所述固定器的材料包括： 金属材 料或者可吸收材料。
根据本发明的又一个具体实施方式， 所述金属材料包括： 钛合金、 不锈钢、 钽和 /或记忆合金。
根据本发明的又一个具体实施方式， 所述固定器的长度为 3cm~20cm。
本发明提供的肱骨近端固定装置置于肱骨近端髓腔内， 实现了对肱骨头的 有效支撑。 该固定器的上端部具有平面结构的第一接触部和隆起性状的第二接 触部； 这两个部位可分别与肱骨头与肱骨大结节的结构匹配， 对肱骨近端骨折 部位起到有效支撑。 固定器的下端部的远端呈子弹形向远处延伸， 不扩髓， 可 以减少对髓腔血运的破坏。 主钉、 防旋钉和锁定钉与固定器的结合使用， 可以 加强对肱骨近段骨折部位的固定支撑， 防止固定器移位、 滑脱。 本固定装置固 定力强、 没有螺钉进入关节的风险， 不会造成肱骨大结节愈合不全， 可以为肩 关节早期功能锻炼提供有效力学支撑。 附图说明 通过阅读参照以下附图所作的对非限制性实施例所作的详细描述， 本发明 的其它特征、 目的和优点将会变得更明显：
图 1 所示为才艮据本发明提供的一种肱骨近端固定装置的一个具体实施方式 的结构示意图；
图 2所示为根据本发明提供的一种肱骨近端固定装置第一接触部的俯视图。 附图中相同或相似的附图标记代表相同或相似的部件。
附图标记：
Figure imgf000005_0001
具体实施方式
下文的公开提供了许多不同的实施例或例子用来实现本发明的不同结构。 为了简化本发明的公开， 下文中对特定例子的部件和设置进行描述。 此外， 本 发明可以在不同例子中重复参考数字和 /或字母。 这种重复是为了简化和清楚的 目的， 其本身不指示所讨论各种实施例和 /或设置之间的关系。 应当注意， 在附 图中所图示的部件不一定按比例绘制。 本发明省略了对公知组件和处理技术及 工艺的描述以避免不必要地限制本发明。
参考图 1 ,图 1所示为根据本发明提供的一种肱骨近端固定装置的一个具体 实施方式的结构示意图。
所述固定装置包括： 固定器 1、 主钉 2、 防旋钉 3、 锁定钉 4。 在使用时， 将所述固定器 1设置于肱骨近端的髓腔内， 与肱骨近端髓腔相匹配。 为了减少 对髓腔血运的破坏， 所以在固定器 1的表面设置有凹槽。
所述固定器 1的上端部包括第一接触部 11和第二接触部 12;所述第一接触 部 11与肱骨头接触， 用于承托肱骨头。 所述第一接触部 11为平面结构， 以便 与肱骨头有更大的接触面积。 为了更好地支撑肱骨头， 并牢固地安置在髓腔内， 优选的所述第一接触部 11为椭圆形平面。 根据肱骨头在肱骨上的位置以及肱骨 头与髓腔的生理结构关系， 将第一接触部 11与髓腔呈一定角度设置， 以使承托 力达到最佳。 优选的， 该角度为 45° ~50° ， 例如： 45° 、 48° 或者 50° 。
所述第二接触部 12与肱骨大结节接触， 为了与肱骨大结节的结构相匹配， 所述第二接触部 12呈隆起形状。 优选的， 在所述第二接触部 12上设置有侧孔， 当需要缝线固定时， 可通过该側孔实现。
所述固定器 1 的下端部的远端呈子弹形， 与髓腔不接触， 流线型设计减少 对髓腔的尖锐接触， 避免应力过度集中， 也减少了对髓腔内骨髓的破坏。
优选的， 制造所述固定器 1的材料包括： 金属材料或者可吸收材料。 其中， 金属材料包括但不限于： 钛合金、 不锈钢、 钽和 /或记忆合金。 当采用采用记忆 合金时， 固定器 1 体外植入， 在体温状态下复温后充填肱骨近端髓腔实现对肱 骨头的支撑。
优选的， 根据使用人群的身高、 骨骼长度、 肱骨状态、 以及骨折程度、 骨 质疏松程度等的不同， 固定器 1的长度也不相同， 优选的， 所述固定器 1的长 度为 3cm~20cm, 例如： 3cm， 10cm或者 20cm。 居通常患者的生理状况来看， 固定器 1的长度优选为 8cm。
所述主钉 2用于固定所述肱骨头与所述第一接触部 11。 拉肱骨头拉到固定 器 1的第一接触部 11上。
所述防旋钉 3的头部进入肱骨头内， 其尾部与所述固定器 1 固定连接。 优 选的， 所述防旋钉 3的尾部采用螺帽与所述固定器 1进行固定设置。 防旋钉 3 起到固定肱骨头的作用， 使肱骨头不在固定器 1的第一接触部 11上旋转。 由于 三角形结构的稳定性最高， 因此所述防旋钉 3设置为 3个， 其排布优选为三角 形。 参考图 2, 更为优选的， 使主钉 2位于防旋钉 3所组成的三角形的中心。 防 旋钉 3钉没有螺纹， 允许肱骨头部分吸收。 当肱骨头部分吸收后， 肱骨头与第 一接触部 11的接触将更加紧密， 固定器对于骨折部分的承托效果也就更好。 防 旋钉 3的长度根据患者状况不同有所不同， 以不穿入关节为宜。
所述锁定钉 4设置于所述固定器 1的下端部， 用于将所述固定器 1与肱骨 干进行固定连接。
为了减少对髓腔血运的破坏， 同时使得固定器 1 接触髓腔实现稳定固定， 所述固定器 1的近端的截面呈三角形设置。 值得注意的是， 所述固定器 1的近 端是指： 靠近固定器 1上端部的锁定钉 4与第一接触部 11之间的部分。
优选的， 为了便于手术操作中对于各种钉的准确定位， 所述主钉 2、 所述防 旋钉 3和 /或所述锁定钉 4均釆用导向器进行定位设置。
优选的， 本发明提供的固定装置还可以与髓外固定装置联合使用， 进一步 加强固定效果。
在实际使用本发明提供的固定装置时， 要让患者呈沙滩椅位或平卧位， 进 行常规消毒铺无菌巾单； 之后， 三角肌胸大肌肌间沟入路， 显露出患者肱骨近 端骨折部位。
当骨折部位暴露后， 开始固定装置的置入操作。 首先， 于骨折间隙 （即肱 骨头和肱骨干之间）置入撑开钳撑开， 恢复肱骨近端内侧的长度， 用克氏针临 时固定肱骨头在肩胛盂上（保持肱骨近端颈干角在 130° 〜150° 之间）； 然后， 掀开大小结节骨折块， 向外拉肱骨干， 暴露肱骨近端髓腔； 之后， 保持肘关节 向前， 将固定装置向后倾斜 20° ~40° , 插入髓内解剖固定装置至适合深度， 复 位骨折； 在透视监视下使肱骨头与第一接触部 11紧密接触； 通过连接在固定装 置 1上的髓外导向器置入主钉 2， 拉肱骨头与第一接触部 11紧密接触； 随后通 过导向器置入防旋钉 3， 以及固定装置 1远端的锁定钉 4 (使钢板与肱骨千连接 在一起）； 当主钉 2、 防旋钉 3和锁定钉 4全部置入后， 去除髓外导向器； 最后 将大小结节通过张力带方式用不可吸收缝线或钢丝固定在主钉 2或第二接触部 12上。 由于第二接触部 12设置有侧孔， 缝线或钢丝固定可通过测控实现， 固定 效果更好。
本发明提供的固定装置通过骨折的大小结节之间直接进入髓腔， 与肱骨近 端髓腔相匹配， 第一接触部 11呈一定角度承托肱骨头， 第二接触部 12的隆起 承托大结节； 通过主钉 2和防旋钉 3实现肱骨头的固定和防旋。 主钉 2承载力 的传导， 允许主钉 2退钉可实现滑动加压。 固定器 1上具有侧孔， 该侧孔允许 新骨长入。 防旋钉 3长度合适， 骨质吸收后防旋钉 3不会穿入肩关节， 对肩关 节造成伤害。 固定器 1与髓腔匹配实现肱骨近端的内侧支撑。 本发明的固定装 置可实现肱骨头与肱骨千的连接恢复力学支撑， 骨组织包裹固定器 1愈合， 实 现了类似钢筋、 水泥灌注的效果， 固定力强。
虽然关于示例实施例及其优点已经详细说明， 应当理解在不脱离本发明的 精神和所附权利要求限定的保护范围的情况下， 可以对这些实施例进行各种变 化、 替换和修改。 对于其他例子， 本领域的普通技术人员应当容易理解在保持 本发明保护范围内的同时， 工艺步骤的次序可以变化。
此外， 本发明的应用范围不局限于说明书中描述的特定实施例的工艺、 机 构、 制造、 物质组成、 手段、 方法及步骤。 从本发明的公开内容， 作为本领域 的普通技术人员将容易地理解， 对于目前已存在或者以后即将开发出的工艺、 机构、 制造、 物质组成、 手段、 方法或步骤， 其中它们执行与本发明描述的对 应实施例大体相同的功能或者获得大体相同的结果， 依照本发明可以对它们进 行应用。 因此， 本发明所附权利要求旨在将这些工艺、 机构、 制造、 物质组成、 手段、 方法或步骤包含在其保护范围内。

Claims

权 利 要 求 书
1、 一种肱骨近端固定装置， 其中， 所述固定装置包括： 固定器、 主钉、 防 旋钉、 锁定钉。
所述固定器设置于肱骨近端的髓腔内， 与肱骨近端髓腔相匹配；
所述固定器的上端部包括第一接触部和第二接触部； 所述第一接触部与肱 骨头接触， 所述第一接触部为平面结构；
所述第二接触部与肱骨大结节接触， 所述第二接触部呈隆起形状； 所述固定器的下端部的远端呈子弹形， 所述固定器的下端部不与髓腔相接 触；
所述主钉用于固定所述肱骨头与所迷第一接触部；
所述防旋钉的头部进入肱骨头内， 其尾部与所述固定器固定连接； 所述锁定钉设置于所述固定器的下端部， 用于将所述固定器与肱骨干进行 固定连接。
2、 根据权利要求 1所述的固定装置， 其中， 所述固定器表面设置有凹槽。
3、 根据权利要求 1或 2所述的固定装置， 其中， 在所述第二接触部上设置 有侧孔；
4、 根据权利要求 1~3任意一项中所述的固定装置， 其中， 所述第一接触部 与髓腔呈 45° ~50° 设置。
5、 根据权利要求 1~4任意一项所述的固定装置， 其中， 所述防旋钉设置为 3个。
6、 根据权利要求 1所述的固定装置， 其中， 所述防旋钉的尾部采用螺帽与 所述固定器进行固定设置。
7、根据权利要求 1所述的固定装置， 其中， 所述主钉、 所述防旋钉和 /或所 述锁定钉采用导向器进行定位设置。
8、 根据权利要求 1〜7任意一项所述的固定装置， 其中， 制造所述固定器的 材料包括： 金属材料或者可吸收材料。
9、 根据权利要求 8所述的固定装置， 其中， 所述金属材料包括： 钛合金、 不锈钢、 钽和 /或记忆合金。
10、 根据权利要求 1~9任意一项所述的固定装置， 其中， 所述固定器的长 度为 3cm~20cm。
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