WO2022236728A1 - 可自适应患处肿胀的骨折外固定支具 - Google Patents

可自适应患处肿胀的骨折外固定支具 Download PDF

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Publication number
WO2022236728A1
WO2022236728A1 PCT/CN2021/093245 CN2021093245W WO2022236728A1 WO 2022236728 A1 WO2022236728 A1 WO 2022236728A1 CN 2021093245 W CN2021093245 W CN 2021093245W WO 2022236728 A1 WO2022236728 A1 WO 2022236728A1
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WO
WIPO (PCT)
Prior art keywords
brace
buckle
swelling
external fixation
fracture
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PCT/CN2021/093245
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English (en)
French (fr)
Inventor
向谷兮
欧阳志伟
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向谷兮
欧阳志伟
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Application filed by 向谷兮, 欧阳志伟 filed Critical 向谷兮
Priority to PCT/CN2021/093245 priority Critical patent/WO2022236728A1/zh
Priority to CN202180097751.8A priority patent/CN117320765A/zh
Publication of WO2022236728A1 publication Critical patent/WO2022236728A1/zh

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    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds

Definitions

  • the present invention relates to an adjustable external fixation brace, especially a universal mesh plate with shape memory; in particular, the present invention relates to a fracture external fixation brace that can adapt to the swelling of the affected part, especially an automatic
  • the utility model relates to an external fixation support for ankle joint fractures which can be adapted to swelling, and belongs to the technical category of fracture external fixation.
  • CN208552170U discloses the previous generation of adjustable external fixation brace developed by the inventor, which is a shape-memory mesh plate with large ventilation holes, which can directly observe the changes of the disease; the affected part is ventilated, and can prevent the occurrence of pruritus and dermatitis ; The material does not absorb water, the patient dries quickly after bathing, and the patient has good comfort.
  • CN208552170U has a detachable locking connection device with adjustable locking tightness, which can adjust the clamping tightness during the whole course of disease, has good fixing effect, and is convenient for postoperative wound care operations.
  • the disclosed external fixation brace of CN208552170U is composed of polycaprolactone, filler, coupling agent and auxiliary material, and the raw material of the blend is injection molded at one time. It is softened by heating at 70-80° C., hardened and fixed at room temperature, and can be arbitrarily stretched, It can adapt to any artificial surface deformation and is easy for doctors to operate. It can be used for external fixation of upper limbs, neck, chest, waist, lower limbs and other parts.
  • the fixation brace product as a whole directly contacts the affected area, which can easily lead to tenderness points and strong pain in patients.
  • "technical personnel in the field” have never realized that due to the swelling of the fracture affected area, the fixed brace will generate direct pressure on the swollen area. Therefore, there has never been a corresponding active countermeasure in this technical field, let alone There have been no anti-pressure pads, elastic connecting straps (elastic adjustable locking buckles) etc. that actively adapt to swelling.
  • the purpose of the present invention is to provide a fracture external fixation brace that can adapt to the swelling of the affected area, and the anti-pressure pads that respond to the swelling of the affected area are distributed in dots, eliminating the planar compression of the fracture site by the fracture external fixation brace, and ensuring the fracture
  • the normal blood flow of the fracture site can not only fix the fracture site, but also promote the recovery and swelling of the fracture site.
  • Another object of the present invention is to provide a fracture external fixation brace that can adapt to the swelling of the affected area. It uses hydrophobic materials, and its elastic adjustable locking device and anti-pressure pads are all hydrophobic. A certain amount of space is reserved in the room, which is convenient for showering or cleaning the affected area, and is also conducive to post-care.
  • the present invention provides a fracture external fixation brace that can adapt to the swelling of the affected part, which is characterized in that a series of An anti-pressure pad to deal with swelling of the affected area, said anti-pressure pad is fixed on the brace by adhesive on the side facing the brace.
  • the anti-pressure pad is provided with at least one groove or notch on the side facing away from the brace.
  • the adjustable external fixation brace is a plate-shaped blank or a preformed blank, and the preformed blank is prefabricated to roughly fit the ankle joint, wrist joint, knee joint, upper limb, neck, chest, waist, or lower limb shape.
  • an independent swelling anti-pressure liner used in conjunction with the fixed brace is provided, and its front and back sides are separated from the brace.
  • the brace has a base insert pre-embedded into the brace at a position near its edge during injection molding, and the base insert has a structurally symmetrical recess relative to the plane where the brace is located, and the recess is used for It is used to accommodate the main body of the through buckle, the main body of the buckle, or the support nail, so that the through buckle and the buckle are installed on the net plate of the fixed brace through the base insert.
  • one end of the elastic adjustable connecting strap is connected to one side of the fixed brace through a buckle; the other end of the elastic adjustable connecting strap is connected to the other side of the fixed brace through a buckle.
  • both the through buckle and the buckle are provided with base support nails.
  • At least one part of the elastic connecting band itself is made of elastic material with tightness.
  • the anti-pressure pad is made of hydrophobic material.
  • an anti-pressure pad that actively responds to the swelling of the affected part is provided, which solves the problem of excessive compression of the fracture fixation brace on the swelling part of the fracture part, and reduces or even avoids the patient's pain.
  • the elastic adjustable locking device (elastic connecting belt) can exert a certain pressure on the edema of the fracture affected area at the early stage of the disease, and at the same time make appropriate deformation to avoid compressive necrosis, so that it can be actively and moderately adjusted according to the patient's disease course.
  • the fixation state of the fracture fixation brace to the affected area has changed the defect of the prior art that it cannot be automatically adjusted at any time along with the patient's course of disease, and can only be adjusted manually with a lag.
  • the plastic mesh fixed brace itself is equipped with an anti-pressure pad, and is additionally provided with a swelling anti-pressure pad used in conjunction with the fixed brace.
  • One end of the elastic adjustable connecting strap is connected to one side of the fixed brace through a through buckle; the other end of the elastic adjustable connecting strap is connected to the other side of the fixed brace through a buckle; both the through buckle and the buckle are provided with
  • the base supports the nail (as a recess blocking member), so that the through buckle and buckle are connected with the body of the fixed brace, avoiding continuity with the brace, and not tendering the swollen affected part.
  • the swelling anti-pressure pad can be removed to increase the contact area between the affected part and air, which is beneficial to the rehabilitation and nursing of the affected part.
  • Fig. 1A is a schematic view of the use state of an embodiment of the adjustable external fixation brace according to the present invention.
  • Fig. 1B is a perspective view of the assembled state of the adjustable external fixation brace shown in Fig. 1A.
  • Fig. 1C is a perspective view of the distribution of anti-pressure pads in partial section of the adjustable external fixation brace shown in Fig. 1B.
  • Fig. 1D is a schematic diagram of the structure of the anti-pressure liner of the adjustable external fixation brace as shown in Fig. 1A.
  • Fig. 1E is a schematic diagram of the structure of the independent anti-pressure liner of the adjustable external fixation brace shown in Fig. 1A.
  • Fig. 2 is a schematic diagram of the structural principle of the elastic connecting band of an embodiment of the adjustable external fixation brace according to the present invention.
  • Fig. 3A and Fig. 3B are schematic diagrams of the through-buckle or buckle-embedded base structure of the adjustable external fixation brace according to the present invention.
  • Fig. 4A and Fig. 4B are schematic diagrams of the through-buckle structure principle of an embodiment of the adjustable external fixation brace according to the present invention.
  • FIG. 5A and FIG. 5B are schematic diagrams of the buckling structure principle of an embodiment of the adjustable external fixation brace according to the present invention.
  • the adjustable external fixation brace 1 is composed of a plastic mesh plate with a series of large holes developed by the applicant, which softens when heated, can be shaped arbitrarily, and can be molded at room temperature. Then sclerosis fixation, wherein an embodiment can be used for ankle joint external fixation.
  • the blank of the adjustable external fixation brace 1 can be a sheet material, or it can be prefabricated into the shape of the heel, ankle joint, and sole of the foot when leaving the factory.
  • the blank Before being worn by the patient, the blank is placed in hot water at approximately 75 degrees Celsius to soften the blank for 1-2 minutes. Preferably, during the softening process, the blank 1 is rotated and turned over in hot water, so that it is evenly heated and softened.
  • the blank When wearing it to the patient, first fix the soles and arches of the foot. During the wearing process, the blank can be stretched and extended arbitrarily according to the size and shape of the patient's foot, so that all parts of the blank can fit the various parts of the patient's foot better. position; after the calcaneus is fixed, an independent anti-pressure liner 6 can be placed under the opening of the blank (see Figure 1E), and then the instep buckle (elastic connecting belt) 4 can be fastened.
  • an independent anti-pressure liner 6 can be placed under the opening of the blank (see Figure 1E), and then the instep buckle (elastic connecting belt) 4 can be fastened.
  • the blank 1 After the blank 1 is cooled to room temperature and hardened, the blank 1 is shaped to form an adjustable external fixation brace 1 tailored for the patient.
  • the buckle belt 4 is an elastic connection belt with elasticity itself.
  • One end of the elastic connecting band 4 is fixed in the buckle 2 disposed adjacent to one edge of the blank 1 ; the other end of the elastic connecting band 4 is fixed in the buckle 3 disposed adjacent to the other edge of the blank 1 .
  • the plastic and adjustable mesh fixing brace 1 is provided with enough ventilating holes 7, so that the patient's foot is ventilated, does not affect bathing, facilitates cleaning of the skin of the affected part, and is beneficial to the recovery of the patient. , can alleviate the pain of patients in the recovery process.
  • a series of preventive measures for increasing the pressure on the patient's foot due to swelling are provided at the inner side of the plastic and adjustable mesh fixed brace 1.
  • Pressure gaskets including horizontal edge anti-pressure gaskets 51, vertical edge anti-pressure gaskets 52, independent anti-pressure gaskets 6, wherein the horizontal edge anti-pressure gaskets 51 and the vertical edge anti-pressure gaskets 52 are all passed through the back glue 53 It is bonded on the surface of the mesh fixed brace 1 before leaving the factory, and the independent anti-pressure liner 6 has no back glue, and is mainly used after the mesh fixed brace 1 is shaped to prevent the edge of the mesh fixed brace 1 The instep of the patient is compressed, thereby causing discomfort, and the use of the independent anti-pressure gasket 6 can well alleviate this discomfort.
  • the assembly effect is shown in Figure 1C.
  • two anti-pressure gaskets 52 in contact with the ankle joint can be provided, which are respectively located on both sides inside the plastic mesh brace 1, and are used for cushioning brace 1 on both sides of the ankle.
  • the raised compression is used to deal with the increased pressure of the mesh fixation brace 1 on the foot due to the swelling of the patient's foot on the inside and outside of the ankle joint.
  • a mesh fixed brace 1 On a mesh fixed brace 1, horizontal edge and vertical edge anti-pressure pads 51, 52 are provided with adhesive backing 53, and are provided with notch 54 for adapting to curved surface deformation, and 9-10 pieces can be set, and the dots are distributed in plasticity.
  • the inner side of the edge of the mesh brace 1 is used to buffer the compression of the affected part by its edge; and an independent anti-pressure liner 6 is provided.
  • the independent anti-pressure liner 6 is placed in the middle of the plastic mesh brace 1 (the instep and the lower end of the calf), and together with the plastic mesh brace 1 forms a closed barrel-shaped fixing structure, which works together to fix the affected part Function: due to the flexibility of the independent anti-pressure liner 6, the pressure of the plastic mesh brace 1 on the swollen part of the foot is relieved, and the pressure of the elastic connecting band 4 on the swollen affected part is blocked at the same time; when the swelling of the affected part is eliminated, The independent anti-pressure liner 6 can be removed to increase the area of the affected part in contact with the air, thereby facilitating the rehabilitation and nursing of the affected part.
  • the through buckle 2 and the buckle 3 can be installed on one side of the plastic mesh brace 1, and the elastic connecting belt 4 is inserted on any side, and the other side is non-returning; a set of through buckle 2, buckle 3, elastic connecting belt 4 constitute a set of connecting devices.
  • a set of through buckle 2, buckle 3, elastic connecting belt 4 constitute a set of connecting devices.
  • there are ⁇ 2 sets of connection devices for the plastic mesh brace 1 and in one embodiment, 4 sets are used.
  • the adjustable external fixation brace 1 according to the present invention can be stretched arbitrarily and can be artificially formed into any curved surface deformation, the clinical operation is simple and convenient, and can be used in upper limbs, neck, chest, waist, lower limbs and other parts .
  • the elastic connecting band 4 As shown in FIG. 2 , one end of the elastic connecting band 4 is fixed on the through buckle 2 , and the other end is fixed on the buckle 3 .
  • the elastic connecting band 4 itself has at least one elastic portion 41 , which allows the elastic connecting band 4 to elongate properly as the patient's foot swells, thereby reducing the pressure on the patient's foot.
  • the elastic connecting band 4 has a fixed end 42 limited by the through buckle 2 and a series of positioning holes 43 allowing insertion and positioning by the buckle 3 .
  • the through buckle 2 and the buckle 3 have a common embedded assembly base 100 in which the wings 103 are injection-molded inside the adjustable external fixation brace 1 .
  • the embedded assembly base 100 has symmetrical recesses 101 , 102 .
  • a shaft hole 104 is provided at the center of the bottom of the recesses 101 , 102 .
  • On both sides of the shaft hole 104 provided at the bottom of the recesses 101 and 102 there are support nail passing holes 105 .
  • At least two injection through-holes 106 are provided on the wing portion 103 .
  • at least one auxiliary injection molding material injection through hole 106 ′ ( FIG.
  • the inside of the main body 200 of the through buckle 2 has a channel 201 for accommodating the fixed end 42 of the elastic connecting band 4 and a channel 204 for accommodating the elastic connecting band 4, and the size of the channel 201 is larger than The internal dimensions of channel 204, therefore, have a step 205 between channel 201 and channel 204.
  • the buckle main body 200 has at least two non-return posts 202, and each non-return post 202 can rotate freely in the central shaft hole 104 embedded in the assembly base 100, so that the elastic connecting band 4 can be positioned in any direction, ensuring that it can be connected with the buckle 3 Align, so that the fastening operation of the elastic connecting band 4 is convenient.
  • each non-return post 202 is a through button body 200 , and the other free end has a non-return hook 203 .
  • the non-return hooks 203 at the free ends of the non-return posts 202 of the through button body 200 pass through the central shaft hole 104 embedded in the assembly base 100 from the recess 101, they are first elastically deformed radially inward to facilitate passing through the central shaft hole.
  • the non-return hooks 203 at the free ends of the non-return posts 202 are elastically deformed radially outward, hooked on the bottom 107 of the recess 102, so that the through buckle main body 200 with each non-return post 202 cannot Pull it out from the embedded assembly base 100 .
  • the support nail 108 is installed in the recess 102 embedded in the assembly base 100, on the one hand, the recess 102 is blocked, so that the inner surface of the brace 1 is flat, and the edge of the recess 102 is prevented from exerting pressure on the swollen part of the patient's foot , on the other hand, the through-buckle main body 200 can be more reliably installed on the embedded assembly base 100 .
  • a truncated cone 109 is provided at the inner center of the support nail 108 .
  • the free end of the cone truncated 109 is pushed into the space formed between the free ends of the non-return posts 202, so that the non-return hook 203 cannot be retracted radially inward, so that through The installation of the buckle body 200 is more secure.
  • the support pin 108 itself is also securely positioned in the recess 102 .
  • the support pin 108 has at least two non-return studs 110 with non-return hooks 111 .
  • the non-return hooks 111 at the free ends of each non-return post 110 pass through the hole 105 of the non-return post embedded in the assembly base 100 from the recess 102, they are first elastically deformed radially inwards, so as to pass through the non-return post.
  • each non-return hook 111 is elastically deformed radially outward, hooked on the bottom 112 of the recess 101, so that the supporting nails 108 with each non-return hook 111 cannot Pull it out from the embedded assembly base 100 .
  • the buckle body 300 of the buckle 3 has a guide head 301 .
  • a hook 302 is formed between the guiding head 301 and the cover plate 303 of the concave portion 101 .
  • the buckle main body 300 has at least two non-return posts 304, and each non-return post 304 can rotate freely in the central shaft hole 104 embedded in the assembly base 100, so that the direction of the buckle 3 is consistent with the extending direction of the elastic connecting band 4, ensuring It can be aligned with the through buckle 2 so as to facilitate the fastening operation of the elastic connecting band 4 .
  • each non-return post 304 is a buckle body 300 , and the other free end has a non-return hook 305 .
  • the non-return hooks 305 at the free ends of the non-return posts 304 of the buckle main body 300 pass through the central shaft hole 104 embedded in the assembly base 100 from the recess 101, they are first elastically deformed radially inward to facilitate passing through the central shaft hole.
  • the non-return hooks 305 at the free ends of the non-return posts 304 are elastically deformed radially outward, hooked on the bottom surface 107 of the recess 102, so that the buckle main body 300 with each non-return post 304 It cannot be pulled out from the embedded mounting base 100 .
  • the support nail 108 is installed in the recess 102 embedded in the assembly base 100.
  • the recess 102 is blocked, so that the inner surface of the brace 1 is flat, and the edge of the recess 102 is prevented from exerting pressure on the swollen part of the patient's foot.
  • the buckle body 300 can be more reliably installed on the embedded assembly base 100 .
  • a truncated cone 109 is provided at the inner center of the support nail 108 .
  • the free end of the cone 109 is pushed into the space formed between the free ends of the non-return posts 304, so that the non-return hook 305 cannot be retracted radially inward, so that the locking
  • the installation of the buckle body 300 is more secure.
  • the support pin 108 itself is also securely positioned in the recess 102 .
  • the support pin 108 has at least two non-return studs 110 with non-return hooks 111 .
  • the non-return hooks 111 at the free ends of each non-return post 110 pass through the non-return post hole 105 embedded in the assembly base 100 from the recess 102, they are first elastically deformed radially inwards to facilitate passing through the non-return post.
  • each non-return hook 111 is elastically deformed radially outward, and is hooked on the bottom surface 112 of the recess 101, so that the support nail 108 with each non-return hook 111 cannot be removed from the The embedded assembly base 100 is pulled out.
  • the embedded assembly base 100 is common to the through buckle 2 and the buckle 3; the embedded assembly base 100 is structurally symmetrical relative to the inside and outside of the brace 1; the embedded assembly base 100 can be in a plane relative to the brace 1 asymmetrical.
  • the present invention provides a fracture external fixation brace 1 that can adapt to the swelling of the affected area.
  • Anti-pressure pads 51, 52 for dealing with swelling of the affected area the anti-pressure pads 51, 52 are fixed on the brace 1 by back glue 53 on the side facing the brace 1;
  • a series of through buckles 2 are provided;
  • a series of buckles 3 are provided; one end of the elastic connecting band 4 passes through the through buckles 2 It is connected with one side of the brace 1 ; the other end of the elastic connecting band 4 is connected with the other side of the brace 1 through a buckle 3 .
  • the adjustable external fixation brace 1 is a plate-shaped blank or a preformed blank.
  • the preform is preformed to conform to the shape of the ankle, wrist, knee, upper body, neck, chest, waist, or lower body.
  • the anti-pressure pads 51 , 52 are provided with at least one groove or notch 54 on a side facing away from the brace 1 .
  • an independent swelling anti-pressure liner 6 used in conjunction with the fixed brace 1 is also provided, and its front and back sides are separated from the brace.
  • the brace 1 has a base insert 100 embedded in the brace 1 during injection molding near its edge.
  • the base insert 100 has structurally symmetrical recesses 101, 102 with respect to the plane where the brace 1 is located, wherein the recesses 101 (102) on one side are used to accommodate the through buckle main body 200 or the buckle main body 300, so that The through buckle 2 and the buckle 3 are installed on the mesh plate of the fixed support 1 through the base insert 100; the recess 102 (101) on the other side is used to accommodate the base support nail 108, and the base support nail 108 makes the main body of the through buckle 200.
  • the buckle main body 300 is reliably installed on the base insert 100 to form the through buckle 2 and the buckle 3 respectively.
  • the base insert 100 has at least one wing 103 for pre-embedding the brace 1, and each wing 103 is provided with a through hole 106 for injecting brace material.
  • At least one part of the elastic connecting band 4 itself is made of an elastic material that can be loosened or tightened freely with swelling.
  • At least one of the anti-pressure pads 51, 52 and the independent swelling anti-pressure pad 6 is made of hydrophobic material.

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  • Chemical Kinetics & Catalysis (AREA)
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Abstract

一种可自适应患处肿胀的骨折外固定支具（1），在分布有大通风孔的形状记忆性网状板的靠近边缘处，设有一系列相互间隔的用于应对患处肿胀的防压衬垫（51，52），防压衬垫（51，52）在面对支具（1）的一侧面通过背胶固定在支具（1）上；在邻近支具（1）的一侧的边缘处，设有一系列通扣（2）；在邻近支具（1）的另外一侧的边缘处，设有一系列卡扣（3）；弹性连接带（4）的一端通过通扣（2）与支具（1）的一侧相连；弹性连接带（4）的另外一端通过卡扣（3）与支具（1）的另外一侧相连。该骨折外固定支具（1）主动应对患处肿胀，消除了骨折外固定支具（1）对骨折部位的面状压迫，确保了骨折部位的正常血液流动，既可以固定骨折部位，又促进了骨折部位康复、消肿。

Description

可自适应患处肿胀的骨折外固定支具 技术领域
本发明涉及一种可调节外固定支具，尤其是一种具有形状记忆性的通用网状板；特别是，本发明涉及一种可适应患处肿胀的骨折外固定支具，尤其是一种自可适应肿胀的踝关节骨折外固定支具，属于骨折外固定术的技术范畴。
背景技术
CN208552170U公开了本发明人研发的上一代可调节外固定支具，其是分布有大通风孔的形状记忆性网状板，可直视病情变化；患部通风透气，可预防瘙痒症、皮炎的发生；材料不吸水，患者沐浴后干燥快，患者舒适性好。
CN208552170U具有可拆卸、可调节锁紧松紧度的锁定连接装置，全病程调节夹持松紧度，固定效果好，便于术后伤口护理操作。
CN208552170U公开的外固定支具由聚己内酯、填充料、偶联剂和辅料组成的共混物原料一次性注塑成型，70-80℃加热软化，室温下硬化固定，可被任意拉伸、可适应任何人为的曲面变形，医生操作简捷，可用于上肢、颈部、胸部、腰部、下肢等部位的外固定。
在CN208552170U的临床实践中，又突破了本领域的技术人员的传统认知，使得以上技术得以继续发展。
例如，在骨折固定支具技术领域，固定支具产品整体直接与患处接触，易导致患者出现压痛点，痛感较强。对于医疗器械生产厂家来说，“本领域的技术人员”从来没有意识到由于骨折患处出现肿胀，固定支具对肿胀部位会产生直接压力，因此，本技术领域从来没有相应的主动应对措施，更没有出现过主动适应肿胀的防压垫、弹性连接带(弹性可调锁紧扣)等。
发明概述
本发明的目的是提供一种可自适应患处肿胀的骨折外固定支具，其应对患处肿胀的防压垫点状分布，消除了骨折外固定支具对骨折部位的面状压迫，确保了骨折部位的正常血液流动，既可以固定骨折部位，又促进了骨折部位康复、消肿。
本发明的另外一个目的是提供一种可自适应患处肿胀的骨折外固定支具，其采用疏水性材料，而且其弹性可调锁紧器具、防压垫都具备疏水性，各防压垫之间预留一定的空间，可方便患处淋浴或清洁，也有利于后期护理。
为此，本发明提供了一种可自适应患处肿胀的骨折外固定支具，其特征在于，在分布有大通风孔的形状记忆性网状板的靠近边缘处，离散地分布一系列用于应对患处肿胀的防压垫，所述防压垫在面对支具的一侧通过粘接剂固定在所述支具上。
优选地，所述防压垫在背对所述支具的一侧设有至少一个沟槽或缺口。
优选地，所述可调节外固定支具为板状坯料或预成型坯料，所述预成型坯料预制成大致适应踝关节、腕关节、膝关节、上肢、颈部、胸部、腰部、或下肢的形状。
优选地，设有与固定支具配套使用的独立肿胀防压衬垫，其正反两面都与所述支具相互分离。
优选地，所述支具在靠近其边缘的部位具有在注塑时预埋入支具的底座嵌件，该底座嵌件相对于所述支具所在的平面具有结构对称的凹部，所述凹部用于容纳通扣主体、卡扣主体、或支撑钉，使得通扣、卡扣通过底座嵌件安装在固定支具网板上。
优选地，弹性可调连接带的一端通过通扣与固定支具的一侧相连；弹性可调连接带的另外一端通过卡扣与固定支具的另外一侧相连。
优选地，所述通扣和卡扣都设有底座支撑钉。
优选地，所述弹性连接带的至少一个部位自身由具有松紧的弹性材料制成。
优选地，所述防压垫由疏水性材料制成。
根据本发明，设置了主动应对患处肿胀的防压垫，解决了骨折固定支具对骨折部位肿胀处的过度压迫，减轻甚至避免了患者的疼痛感。
根据本发明，弹性可调锁紧装置(弹性连接带)对病程初期骨折患处水肿施加一定压力的同时又可做出适当的形变，避免压迫性坏死，使得可以根据患者的病程，主动地适度调节骨折固定支具对患处的固定松紧状态，改变了现有技术不可随患者病程进行随时自动调节、只能人工滞后调节的缺陷。
根据本发明，所述可塑性网状固定支具本身配置有防压垫，另外设有与固定支具配套使用的肿胀防压垫，弹性连接带两端的通扣、卡扣通过底座嵌件安装在固定支具网板上。弹性可调连接带的一端通过通扣与固定支具的一侧相连；弹性可调连接带的另外一端通过卡扣与固定支具的另外一侧相连；所述通扣和卡扣都设有底座支撑钉(作为凹部堵件)，使得所述通扣和卡扣与固定支具本体联接，与支具避免连续，而且不压痛肿胀患处。
根据本发明，当患处肿胀消除后，可除去肿胀防压垫，以增加患处与空气的接触面积，有利于患处康复、护理。
附图说明
图1A是根据本发明的可调节外固定支具一个实施例的使用状态示意图。
图1B是如图1A所示的可调节外固定支具的装配状态透视图。
图1C是如图1B所示的可调节外固定支具局部剖的防压垫分布透视图。
图1D是如图1A所示的可调节外固定支具的防压衬垫结构示意图。
图1E是如图1A所示的可调节外固定支具的独立防压衬垫结构示意图。
图2是根据本发明的可调节外固定支具一个实施例的弹性连接带结构原理示意图。
图3A和图3B是根据本发明的可调节外固定支具的通扣或卡扣嵌入底座结构原理图。
图4A和图4B是根据本发明的可调节外固定支具一个实施例的通扣结构原理示意图。
图5A和图5B是根据本发明的可调节外固定支具一个实施例的卡扣结构原理示意图。
具体实施方式
如图1A所示，根据本发明的可调节外固定支具1由本申请人之前研发的可塑性、具有一系列大孔的网状板构成，其加温则软化、可任意塑形、在室温下则硬化固定，其中一个实施例可用于踝关节外固定。
在该实施例中，可调节外固定支具1的坯料可以是板料，也可以在出厂时预制成大致呈脚跟、踝关节、脚掌部位的形状。
在给患者佩戴之前，将坯料放置在大约75摄氏度的热水中，使得坯料软化1-2分钟。优选地，在软化过程中，使坯料1在热水中转动、翻转，使之受热均匀、软化均匀。
在给患者穿戴时，先固定脚掌、足弓部位，穿戴过程中，可以根据患者的足部大小与形状对坯料进行任意拉伸、延展，让坯料的各个部位都更贴合患者足部的各个部位；在固定跟骨之后，可以在坯料的开口下面垫入独立防压衬垫6(见图1E)，然后系上脚面扣带(弹性连接带)4。
待坯料1冷却至室温硬化之后，坯料1就完成定型，形成为患者量身定制的可调节外固定支具1。
特别是，扣带4是自身具有弹性的弹性连接带。该弹性连接带4的一端固定在坯料1邻近一个边缘设置的通扣2中；该弹性连接带4的另外一端固定在坯料1邻近另外一个边缘设置的卡扣3中。
根据本发明，可塑性、可调节外的网状固定支具1上设有足够多、足够大的透气孔7，使得患者的足部通风透气、不影响洗澡、方便清洁患部皮肤，有利于患者康复，可以减轻患者在 康复过程中的痛苦。
根据本发明，如图1A、图1B、图1C所示，在可塑性、可调节外的网状固定支具1内侧邻近边缘处，设有一系列的应对因肿胀而对患者足部增加压力的防压垫片，包括水平边缘防压垫片51、垂直边缘防压垫片52、独立防压衬垫6，其中，水平边缘防压垫片51和垂直边缘防压垫片52都通过背胶53在出厂前粘接在网状固定支具1的表面上，而独立防压衬垫6无背胶，主要是在网状固定支具1塑型后使用，防止网状固定支具1的边缘对患者的脚面产生压迫，从而造成不适，采用独立防压垫片6能很好地缓解这种不适。其装配效果如图1C所示。
在一件网状固定支具1上，与踝关节接触的防压垫片52可以设有2件，分别位于可塑性网状支具1内部的两侧，用于缓冲支具1对脚踝两侧凸起的压迫，即用于在踝关节内侧和外侧应对因患者足部的肿胀使得网状固定支具1对足部增加的压力。
在一件网状固定支具1上，水平边缘和垂直边缘防压垫片51、52带背胶53，设有便于适应曲面变形的缺口54，可以设置9-10件，点状分布于可塑性网状支具1边沿的内侧，以缓冲其边沿可能对患处的压迫；而独立防压衬垫6备有一件。在独立防压衬垫6上，设有一系列透气孔8和两侧的缺口9，该缺口9使得独立防压衬垫6更便于在脚面上变形，适应脚面的形状，并且增强脚面部位的透气性。
特别是，独立防压衬垫6放置于可塑性网状支具1的中间(脚背和小腿下端)，同可塑性网状支具1一起组成封闭的桶状固定结构，协同一致起到对患处的固定作用；由于独立防压衬垫6有柔韧性，因此缓解了可塑性网状支具1对脚的肿胀部位的压力，同时阻挡了弹性连接带4可能对肿胀患处的压迫；当患处肿胀消除后，可除去独立防压衬垫6，以增加患处与空气接触的面积，从而有利于患处康复、护理。
根据需要，通扣2和卡扣3可安装在可塑性网状支具1一边一个，弹性连接带4在任意一边插入，在另外一边止回；一组通扣2、卡扣3、弹性连接带4构成一套连接装置。根据本发明，可塑性网状支具1的连接装置≥2套，在一个实施例中，采用4套。
在其他的实施例中，因为根据本发明的可调节外固定支具1可被任意拉伸、可人为形成任何曲面变形，临床操作简捷，可用于上肢、颈部、胸部、腰部、下肢等部位。
如图2所示，弹性连接带4的一端固定在通扣2上，另外一端固定在卡扣3上。特别是，弹性连接带4本身具有至少一处富有弹性的部分41，允许弹性连接带4随着患者足部的肿胀而适当伸长，从而减轻对患者足部的压力。尤其是，弹性连接带4具有由通扣2限位的固定端42和允许由卡扣3插入定位的一系列定位孔43。
如图3A和3B所示，通扣2和卡扣3具有通用的将翼部103注塑在可调节外固定支具1内部的嵌入装配底座100。所述嵌入装配底座100具有对称的凹部101、102。在凹部101、102的底部的中央位置设有轴孔104。在凹部101、102的底部设置的轴孔104的两侧，设有支撑钉穿过孔105。在翼部103上设有至少两个注塑材料注入通孔106。优选地，在翼部103所在平面上，在远离两个注塑材料注入通孔106连线的位置，设置至少一个辅助注塑材料注入通孔106’(图3B)，这样，翼部103可以更加牢固地嵌入在可调节外固定支具1的内部，不容易在给患者足部佩戴可调节外固定支具1的过程中因为嵌入装配底座100相对于可调节外固定支具1的转动而被拔出可调节外固定支具1，从而提升了产品的可靠性。
如图4A和图4B所示，通扣2的通扣主体200内部具有用于容纳弹性连接带4的固定端42的通道201和用于容纳弹性连接带4的通道204，通道201的尺寸大于通道204的内部尺寸，因此，通道201和通道204之间具有台阶205。
通扣主体200具有至少两个止回柱202，各止回柱202可以在嵌入装配底座100的中央轴孔104内自由转动，使得弹性连接带4可以定位在任何方向，确保可以与卡扣3对准，以便于弹性连接带4的系紧操作。
各止回柱202的一端是通扣主体200，另外一自由端具有止回钩203。通扣主体200的各止回柱202的自由端的止回钩203在从凹部101穿过嵌入装配底座100的中央轴孔104时，先相互径向向内弹性变形，以便于穿过中央轴孔104；一旦穿过该中央轴孔104，各止回柱202自由端的止回 钩203径向向外弹性变形，钩在凹部102的底部107，使得带各止回柱202的通扣主体200不能从嵌入装配底座100拔出来。
如图4B所示，支撑钉108安装在嵌入装配底座100的凹部102内，一方面封堵凹部102，使得支具1的内侧表面平整，避免凹部102的边缘对患者足部的肿胀部施加压力，另外一方面使得通扣主体200更加可靠地安装在嵌入装配底座100上。
具体地说，在支撑钉108的内侧中央位置，设有锥台109。在支撑钉108的安装状态下，锥台109的自由端被顶入在各止回柱202的自由端之间形成的空间内，使得止回钩203无法径向向内回缩，从而使得通扣主体200的安装更加牢固。
而支撑钉108自身也可靠地定位在凹部102内。特别是，支撑钉108具有至少两个止回柱110，该止回柱110具有止回钩111。当时，各止回柱110自由端的止回钩111在从凹部102穿过嵌入装配底座100的止回柱穿过孔105时，先相互径向向内弹性变形，以便于穿过止回柱穿过孔105；一旦穿过该止回柱穿过孔105，各止回钩111径向向外弹性变形，钩在凹部101的底部112上，使得带各止回钩111的支撑钉108也不能从嵌入装配底座100拔出来。
如图5A和图5B所示，卡扣3的卡扣主体300具有引导头301。引导头301和凹部101的盖板303之间形成卡钩302。
卡扣主体300具有至少两个止回柱304，各止回柱304可以在嵌入装配底座100的中央轴孔104内自由转动，使得卡扣3的方向与弹性连接带4的延伸方向一致，确保可以与通扣2对准，以便于弹性连接带4的系紧操作。
各止回柱304的一端是卡扣主体300，另外一自由端具有止回钩305。卡扣主体300的各止回柱304的自由端的止回钩305在从凹部101穿过嵌入装配底座100的中央轴孔104时，先相互径向向内弹性变形，以便于穿过中央轴孔104；一旦穿过该中央轴孔104，各止回柱304自由端的止回钩305径向向外弹性变形，钩在凹部102的底面107上，使得带各止回柱304的卡扣主体300不能从嵌入装配底座100拔出来。
如图5B所示，支撑钉108安装在嵌入装配底座100的凹部102内，一方面封堵凹部102，使得支具1的内侧表面平整，避免凹部102的边缘对患者足部的肿胀部施加压力，另外一方面使得卡扣主体300更加可靠地安装在嵌入装配底座100上。
具体地说，在支撑钉108的内侧中央位置，设有锥台109。在支撑钉108的安装状态下，锥台109的自由端被顶入在各止回柱304的自由端之间形成的空间内，使得止回钩305无法径向向内回缩，从而使得卡扣主体300的安装更加牢固。
而支撑钉108自身也可靠地定位在凹部102内。特别是，支撑钉108具有至少两个止回柱110，该止回柱110具有止回钩111。当各止回柱110自由端的止回钩111在从凹部102穿过嵌入装配底座100的止回柱穿过孔105时，先相互径向向内弹性变形，以便于穿过止回柱穿过孔105；一旦穿过该止回柱穿过孔105，各止回钩111径向向外弹性变形，钩在凹部101的底面112上，使得带各止回钩111的支撑钉108也不能从嵌入装配底座100拔出来。
特别是，嵌入装配底座100对于通扣2和卡扣3是通用的；嵌入装配底座100相对于支具1的内侧和外侧是结构对称的；嵌入装配底座100相对于支具1所在平面可以是不对称的。
总之，本发明提供了一种可自适应患处肿胀的骨折外固定支具1，其特征在于，在分布有大通风孔7的形状记忆性网状板的靠近边缘处，设有一系列相互间隔的用于应对患处肿胀的防压衬垫51、52，所述防压衬垫51、52在面对所述支具1的一侧面通过背胶53固定在所述支具1上；在邻近所述支具1的一侧的边缘处，设有一系列通扣2；在邻近所述支具1的另外一侧的边缘处，设有一系列卡扣3；弹性连接带4的一端通过通扣2与所述支具1的一侧相连；弹性连接带4的另外一端通过卡扣3与所述支具1的另外一侧相连。
特别是，所述可调节外固定支具1为板状坯料或预成型坯料。
特别是，所述预成型坯料预制成适应踝关节、腕关节、膝关节、上肢、颈部、胸部、腰部、或下肢的形状。
特别是，防压衬垫51、52在背对所述支具1的一侧面设有至少一个沟槽或缺口54。
特别是，还设有与固定支具1配套使用的独立肿胀防压衬垫6，其正反两侧面都与所述支具相互分离。
特别是，支具1在靠近其边缘的部位具有在注塑时预埋于支具1内部的底座嵌件100。
特别是，该底座嵌件100相对于所述支具1所在的平面具有结构对称的凹部101、102，其中一侧的凹部101(102)用于容纳通扣主体200或卡扣主体300，使得通扣2、卡扣3通过底座嵌件100安装在固定支具1的网板上；另外一侧的凹部102(101)用于容纳底座支撑钉108，所述底座支撑钉108使得通扣主体200、卡扣主体300可靠地安装在底座嵌件100上，分别形成所述通扣2和卡扣3。
特别是，所述底座嵌件100具有用于预埋入支具1的至少一个翼部103，每个翼部103上设有至于一个用于注入支具原料的通孔106。
特别是，所述弹性连接带4的至少一个部位自身由可以随着肿胀自由松紧的弹性材料制成。
特别是，所述防压衬垫51、52和所述独立肿胀防压衬垫6中的至少其中之一由疏水性材料制成。

Claims (10)

  1. 一种可自适应患处肿胀的骨折外固定支具，其特征在于，在分布有大通风孔的形状记忆性网状板的靠近边缘处，设有一系列相互间隔的用于应对患处肿胀的防压衬垫，所述防压衬垫在面对所述支具的一侧面通过背胶固定在所述支具上；在邻近所述支具的一侧的边缘处，设有一系列通扣；在邻近所述支具的另外一侧的边缘处，设有一系列卡扣；弹性连接带的一端通过通扣与所述支具的一侧相连；弹性连接带的另外一端通过卡扣与所述支具的另外一侧相连。
  2. 如权利要求1所述的支具，其特征在于，所述可调节外固定支具为板状坯料或预成型坯料。
  3. 如权利要求2所述的支具，其特征在于，所述预成型坯料预制成适应踝关节、腕关节、膝关节、上肢、颈部、胸部、腰部、或下肢的形状。
  4. 如权利要求1所述的支具，其特征在于，所述防压衬垫在背对所述支具的一侧面设有至少一个沟槽或缺口。
  5. 如权利要求1所述的支具，其特征在于，还设有与固定支具配套使用的独立肿胀防压衬垫，其正反两侧面都与所述支具相互分离。
  6. 如权利要求1所述的支具，其特征在于，所述支具在靠近其边缘的部位具有在注塑时预埋于支具内部的底座嵌件。
  7. 如权利要求1所述的支具，其特征在于，该底座嵌件相对于所述支具所在的平面具有结构对称的凹部，其中一侧的凹部用于容纳通扣主体、卡扣主体，使得通扣、卡扣通过底座嵌件安装在固定支具网板上；另外一侧的凹部用于容纳底座支撑钉，所述底座支撑钉使得通扣主体、卡扣主体可靠地安装在底座嵌件上，分别形成所述通扣和卡扣。
  8. 如权利要求6所述的支具，其特征在于，所述底座嵌件具有用于预埋入支具的至少一个翼部，每个翼部上设有至于一个用于注入支具原料的通孔。
  9. 如权利要求1所述的支具，其特征在于，所述弹性连接带的至少一个部位自身由可以随着肿胀自由松紧的弹性材料制成。
  10. 如权利要求1所述的支具，其特征在于，所述防压衬垫和所述独立肿胀防压衬垫中的至少其中之一由疏水性材料制成。
PCT/CN2021/093245 2021-05-12 2021-05-12 可自适应患处肿胀的骨折外固定支具 WO2022236728A1 (zh)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN201642467U (zh) * 2010-03-22 2010-11-24 丁春香 下肢骨折固定支具
US20130237892A1 (en) * 2010-04-01 2013-09-12 Grampian Health Board Fracture brace
CN107715184A (zh) * 2017-10-12 2018-02-23 向谷兮 可调节外固定支具及其材料配方、制作工艺和使用方法
CN109044583A (zh) * 2018-07-02 2018-12-21 上海黑焰医疗科技有限公司 一种低温热塑康复支具及其制作方法
CN208725981U (zh) * 2017-11-20 2019-04-12 皖南医学院弋矶山医院 一种带有防压保护功能的踝关节固定支具

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN201642467U (zh) * 2010-03-22 2010-11-24 丁春香 下肢骨折固定支具
US20130237892A1 (en) * 2010-04-01 2013-09-12 Grampian Health Board Fracture brace
CN107715184A (zh) * 2017-10-12 2018-02-23 向谷兮 可调节外固定支具及其材料配方、制作工艺和使用方法
CN111479597A (zh) * 2017-10-12 2020-07-31 武汉市迅舒科技有限公司 可调节外固定支具
CN208725981U (zh) * 2017-11-20 2019-04-12 皖南医学院弋矶山医院 一种带有防压保护功能的踝关节固定支具
CN109044583A (zh) * 2018-07-02 2018-12-21 上海黑焰医疗科技有限公司 一种低温热塑康复支具及其制作方法

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