WO2021031332A1 - Dura mater opening closing apparatus - Google Patents

Dura mater opening closing apparatus Download PDF

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Publication number
WO2021031332A1
WO2021031332A1 PCT/CN2019/112815 CN2019112815W WO2021031332A1 WO 2021031332 A1 WO2021031332 A1 WO 2021031332A1 CN 2019112815 W CN2019112815 W CN 2019112815W WO 2021031332 A1 WO2021031332 A1 WO 2021031332A1
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WO
WIPO (PCT)
Prior art keywords
component
dural
opening
patch
inner support
Prior art date
Application number
PCT/CN2019/112815
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French (fr)
Chinese (zh)
Inventor
江研伟
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江研伟
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Publication of WO2021031332A1 publication Critical patent/WO2021031332A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes
    • A61F2002/0072Delivery tools therefor

Definitions

  • the invention relates to a surgical device, in particular to a dural opening closing device, which belongs to the field of medical equipment.
  • the present invention provides a convenient dural opening closure device.
  • One aspect of the present invention provides a hard film opening closing device, which includes an inner support component, an outer compression component, a connection component, and a packaging component.
  • the packaging component includes a pipe. The inner support component, the connection component and the external pressure are sequentially placed in the pipe. Tight component
  • the inner support component includes an expansion material, the inner support component radially expands from a first structure to a second structure under the action of the expansion material, the inner support component maintains the first structure in the packaging component, and the first structure
  • the perimeter of the inner support component in one structure is smaller than the perimeter of the dural opening; when the inner support component separates from the packaging component and enters the dura opening, it radially expands to the second structure, and the inner support component in the second structure state
  • the circumference of the supporting component is greater than the circumference of the dural opening, so that the inner supporting component contacts and covers the inner surface of the dural opening;
  • the external compression component includes a memory metal material, and the external compression component is restored from a contracted structure to an expanded structure under the shape memory of the memory metal material; the external compression component is in a contracted structure in the packaging component; The external compression component returns to the expanded structure after being separated from the packaging component.
  • the circumference of the external compression component in the expanded structure state is greater than the circumference of the dural opening, so that the external compression component contacts and covers the dural opening.
  • connection component is a wire structure
  • connection component clamps the outer edge of the dura opening between the inner support component and the outer compression component between.
  • the dural opening closing device further includes a push rod, the push rod is placed in the packaging component, and arranged at the proximal end of the dural opening closing device, and is in contact with the outer pressing component, It is used to push out the external compression component, the connection component and the internal support component from the packaging component, thereby making the operation easier.
  • the push rod is marked with scale lines along the length direction, so that the pushing distance of the push rod can be accurately controlled, so that the inner support assembly and the outer pressing assembly reach corresponding positions, which is beneficial to the operation of the device.
  • the distal end of the packaging assembly is made of transparent material, which is convenient for the operator to observe and further confirm that the relevant parts are separated from the tube.
  • the swelling material is gelatin sponge, so as to ensure that the inner support component has a relatively good swellability.
  • the inner support component is a composite material composed of a gelatin sponge and a dural patch
  • the dura patch is arranged on both sides of the gelatin sponge, and the dura patch on one side and the inner dural opening Surface contact, and the circumference of the dura patch is greater than the circumference of the dura opening, so that the dura patch contacts and covers the inner surface of the dura opening.
  • Adding the dura mater on the one hand enhances the bonding effect of the internal support component and the inner surface of the dura opening, and on the other hand supports the gelatin sponge to improve its filling strength.
  • the dural patch is made of one or more of type I collagen material, pericardial membrane material, polylactic acid material, expanded polytetrafluoroethylene, silk fibroin, medical polyester film or artificial synthetic repair material. Made of a combination of two materials.
  • the dural patch is made of a combination of one or more of the type I collagen material, polylactic acid material or pericardium material.
  • the dural patch is made of type I collagen material.
  • the dura patch and the gelatin sponge are pasted by a biological protein glue, so that the dura patch and the gelatin sponge adhere more closely.
  • the outer pressing component is an umbrella-shaped structure
  • the inside is arc-shaped
  • a threading hole is provided in the middle to connect with the connecting component.
  • the umbrella-shaped structure design makes the external compression component fit more closely with the outer surface of the dural opening, thereby improving the closing effect of the dural opening.
  • the memory metal material is Nitinol.
  • the external pressing component further includes a hard film patch, one side of the memory metal material is in contact with the hard film patch, and the other side of the hard film patch contacts and covers the hard film
  • the outer surface of the opening, and the circumference of the dural patch is greater than the circumference of the dural opening. Adding the dura mater makes the external compression component fit more closely to the outer surface of the dura opening.
  • the thread structure is made of elastic material. Under the action of the elastic material, the outer edge of the dural opening is more firmly clamped between the inner support component and the outer compression component.
  • the thread structure is composed of catgut, polylactic acid suture, polyglycolide suture, polyglycolic acid PGA suture, polydioxanone suture, silk thread, nylon suture , Polyester suture or polypropylene suture or a combination of one or more.
  • the outer edge of the dura mater opening is firmly clamped between the inner support component and the outer pressing component, so that the closed dura mater opening has a waterproof effect.
  • the inner supporting component, the outer pressing component and the connecting component are all made of biocompatible materials.
  • the dural opening closing device of the present invention has simple structure and convenient operation.
  • the inner support assembly, the connection assembly and the outer compression assembly are pre-assembled in the packaging assembly, which is convenient for access and saves time and effort.
  • the external compression component of the present invention uses a memory metal material, and under the shape memory of the memory metal material, the external compression component is restored from a contracted structure to an expanded structure, thereby better closing the dural opening.
  • the push rod is marked with tick marks along the length direction, so that the pushing distance of the push rod can be accurately controlled, which is convenient for operation.
  • the distal end of the package assembly is made of transparent material, which is convenient for the operator to observe and further confirm that the relevant parts are separated from the tube.
  • Adding the dura mater makes the inner support component fit more closely to the inner surface of the dural opening, and at the same time makes the outer compression component fit more closely to the outer surface of the dural opening.
  • FIG. 1 is a schematic cross-sectional view of the structure of Embodiment 1 of the present invention.
  • FIG. 2 is a diagram of the operation steps of Embodiment 1.
  • FIG. 2 is a diagram of the operation steps of Embodiment 1.
  • Fig. 3 is a schematic diagram of the Nitinol alloy recovering from the contracted structure to the expanded structure.
  • Fig. 4 is a top view of the nickel-titanium alloy in the expanded structure state.
  • Figure 5 is a schematic diagram of the connection between catgut and gelatin sponge.
  • Embodiment 6 is a schematic cross-sectional view of the structure of Embodiment 2 of the present invention.
  • Figure 7 is a schematic structural cross-sectional view of the external compression assembly.
  • FIG. 8 is a diagram of the operation steps of Embodiment 2.
  • Fig. 9 is a schematic diagram showing the restoration of the external compression assembly from the contracted structure to the expanded structure.
  • Fig. 10 is a top view of the external pressing assembly in an unfolded configuration state.
  • Figure 11 is a schematic diagram of the connection between the wire and the inner support assembly.
  • wire structure includes any case of a linear structure, in one embodiment it can be a wire, in another embodiment it can be a rod, preferably made of elastic material In the role of elastic materials, these line structures can have a certain resilience, which can better assist the inner support component and the outer compression component to close the dural opening.
  • Embodiment 1 is a schematic structural cross-sectional view of Embodiment 1 of the dural opening closing device, which includes an inner support component 1, an outer compression component 2, a connection component 3 and a packaging component 4.
  • the packaging component 4 includes a pipe 5 in which an inner supporting component 1, a connecting component 3 and an outer pressing component 2 are placed in sequence, and the inner supporting component 1 and the outer pressing component 2 are connected by the connecting component 3.
  • the inner support component 1 is a gelatin sponge, and the gelatin sponge is compressed to the first structure in advance, as shown in Figure 1, to ensure that the whole can be fitted into the packaging component 4 and can be pushed into the dural opening during operation.
  • the circumference of the gelatin sponge in a structural state is smaller than the circumference of the dural opening.
  • the external pressing component 2 is made of a memory alloy material, such as Nitinol.
  • the nickel-titanium alloy has an umbrella-shaped structure with a circular arc inside, and a threading hole is opened in the middle to connect with the connecting assembly 3.
  • the nickel-titanium alloy is pre-compressed to a shrinkage structure, as shown in FIG.
  • the connecting component 3 is catgut.
  • the distal end of the packaging assembly 4 may be made of a transparent material.
  • the dural opening closure device may also include a push rod.
  • the push rod is placed in the packaging assembly 4 and arranged at the proximal end of the dural opening closure device to contact the external pressing assembly 2 for
  • the outer pressing component 2, the connecting component 3 and the inner supporting component 1 are pushed out from the packaging component 4, and the push rod is marked with a scale line along the length direction.
  • the dural opening closure device may not include a push rod.
  • suitable tools such as endoscopic surgical instruments, can be used to press the outer compression assembly 2, the connection assembly 3 and the inner support assembly. 1 Push out from the package assembly 4 to complete the closed repair of the hard film.
  • FIG 2 is a diagram of the operation steps of the dural opening closure device.
  • the dural opening closure device is placed on the dural opening, and the gelatin sponge, catgut and nickel-titanium alloy in the tube are pushed out of the tube through the push rod.
  • On the graduation line first accurately push the gelatin sponge into the dural opening. After absorbing water, the gelatin sponge expands radially from the first structure to the second structure. At this time, the expanded gelatin sponge touches and covers the inner dural opening. On the surface, the circumference of the gelatin sponge is greater than the circumference of the dural opening.
  • Nitinol is a memory alloy material
  • the Nitinol alloy is restored from the contracted structure to the expanded structure without any external force intervention.
  • the Nitinol in the expanded structure contacts and covers the outside of the hard film opening. On the surface, the circumference of the Nitinol alloy is greater than the circumference of the hard film opening.
  • the outer edge of the dural opening is firmly clamped between the gelatin sponge and the nickel-titanium alloy, thereby closing the dural opening, and the closed dural opening has a waterproof and repairing effect.
  • Fig. 3 is a schematic diagram of the Nitinol alloy recovering from the contracted structure to the expanded structure.
  • the nickel-titanium alloy presents a contraction structure in the package assembly. After the nickel-titanium alloy is separated from the package assembly, it gradually returns to the expanded structure under the shape memory of the memory metal material.
  • the nickel-titanium alloy in the expanded structure contacts and Covering the outer surface of the hard film opening, the perimeter of the nickel-titanium alloy is greater than the perimeter of the hard film opening.
  • the top view of the nickel-titanium alloy in the unfolded state is shown in FIG. 4, and the structure of the nickel-titanium alloy at this time is an umbrella structure.
  • FIG. 5 is a schematic diagram of the connection between catgut and gelatin sponge.
  • the number of catgut is two.
  • the catgut passes through the bottom of the gelatin sponge and penetrates again to fix and support the gelatin sponge.
  • Part of the catgut is placed on the outer surface of the bottom of the gelatin sponge.
  • the gelatin sponge, catgut and nickel-titanium alloy are separated from the package assembly, the gelatin sponge radially expands from the first structure to the second structure in the dura opening.
  • the nickel-titanium alloy undergoes the shape memory of the memory metal material.
  • the contracted structure is restored to the expanded structure.
  • the gelatin sponge and the nickel-titanium alloy are connected by the catgut.
  • the expanded gelatin sponge contacts and covers the inner surface of the dural opening.
  • the circumference of the gelatin sponge is larger than the dura mater.
  • the perimeter of the opening is in contact with and covers the outer surface of the hard film opening with Nitinol, and the perimeter of the Nitinol alloy is greater than the perimeter of the hard film opening.
  • the outer edge of the dural opening is clamped between the gelatin sponge and Nitinol.
  • the thread structure in this embodiment is catgut, in other embodiments it can be catgut or polylactic acid suture or polyglycolide suture or polyglycolic acid PGA suture or polypara-2 Oxyhexanone sutures or silk threads or nylon sutures or polyester sutures or polypropylene sutures or any other material that can be used as a thread structure.
  • Embodiment 2 of the dural opening closure device which includes an inner support assembly 1, an outer compression assembly 2, a connection assembly 3, a packaging assembly 4 and a push rod 6.
  • the packaging component 4 includes a pipe 5 in which an inner supporting component 1, a connecting component 3 and an outer pressing component 2 are placed in sequence, and the inner supporting component 1 and the outer pressing component 2 are connected by the connecting component 3.
  • the inner support component 1 is a composite material composed of a gelatin sponge 1-1 and a dural patch (1-2a and 1-2b). The two sides of the gelatin sponge 1-1 are arranged with dural patch 1-2a and 1 respectively. -2b.
  • the external compression component 2 is a composite material composed of Nitinol 2-1 and the hard film patch 2-2.
  • One side of the Nitinol 2-1 is in contact with the hard film patch 2-2, as shown in Figure 7.
  • the nickel-titanium alloy 2-1 has an umbrella-shaped structure with a circular arc shape inside, and a threading hole is opened in the middle to connect with the connecting assembly 3.
  • the Nitinol 2-1 is pre-compressed to a shrinkage structure, as shown in FIG. 6, to ensure that the whole can be installed in the package assembly 4.
  • the connecting component 3 is a wire made of elastic material.
  • the distal end of the package assembly 4 is made of transparent material.
  • the push rod 6 is placed in the packaging assembly 4, and arranged at the proximal end of the dural opening closing device, and is in contact with the external pressing assembly 2 for connecting the external pressing assembly 2, the connecting assembly 3 and The inner support assembly 1 is pushed out from the packaging assembly 4.
  • the push rod 6 is marked with scale lines along the length direction.
  • FIG 8 is a diagram of the operation steps of the dural opening closure device.
  • the dural opening closure device is placed on the dural opening, and the inner support assembly 1, the silk thread and the outer compression assembly 2 in the tube are pushed out of the tube through the push rod 6.
  • the inner support assembly 1 With the help of the scale line on the push rod 6, the inner support assembly 1 is accurately pushed into the dural opening. After the gelatin sponge 1-1 absorbs water, it expands radially from the first structure to the second structure.
  • the gelatin sponge 1- The circumference of 1 is greater than the circumference of the dural opening, the upper dural patch 1-2a is supported, and the circumference of the dural patch 1-2a is greater than the circumference of the dural opening, so that the dural patch 1-2a touches and covers the inner surface of the dural opening. Then push the outer compression assembly 2 and the wire out of the tube, observe the distal end of the package assembly made of transparent material, and further confirm that the relevant parts are separated from the tube.
  • Nitinol 2-1 is a memory alloy material, Nitinol 2-1 recovers from a contraction structure to an unfolded structure without any external force intervention when it is separated from the package assembly 4, and is hard bonded to Nitinol 2-1.
  • the dura mater 2-2 contacts and covers the outer surface of the dura mater opening, and the perimeters of the nickel-titanium alloy 2-1 and the dura mater patch 2-2 are both greater than the perimeter of the dura mater opening.
  • the outer edge of the dural opening is firmly clamped between the inner support component 1 and the outer pressing component 2 to close the dural opening, and the closed dural opening has a waterproof repair function.
  • FIG. 9 is a schematic diagram of the external compression assembly 2 returning from the contracted structure to the expanded structure.
  • the external compression component 2 is in a contracted structure inside the packaging component. After the external compression component 2 is separated from the packaging component, it gradually returns to the expanded structure under the shape memory of the memory metal material. 1.
  • the attached dural patch 2-2 contacts and covers the outer surface of the dural opening. The perimeters of the Nitinol 2-1 and the dural patch 2-2 are both larger than the perimeter of the dural opening.
  • the top view of the outer pressing assembly 2 in the expanded structure state is shown in FIG. 10, and the structure of the outer pressing assembly 2 at this time is an umbrella structure.
  • FIG. 10 is a schematic diagram of the connection between the wire and the inner support assembly 1.
  • the number of silk threads is 2.
  • the silk threads are threaded out from the bottom of the dural patch 1-2b and inserted again to fix and support the inner support component 1.
  • Part of the silk threads are placed on the dural patch 1-2b The outer surface of the bottom.
  • the gelatin sponge 1-1 expands radially from the first structure to the second structure in the hard film opening, and the nickel titanium alloy 2-1 is in the memory Under the action of the shape memory of the metal material, the contracted structure is restored to the expanded structure.
  • the inner support assembly 1 and the outer compression assembly 2 are connected by a silk thread.
  • the upper dural patch 1-2a is expanded by the gelatin sponge Support, and the circumference of the dural patch 1-2a is greater than the circumference of the dural opening, so that the dural patch 1-2a contacts and covers the inner surface of the dural opening.
  • the dura mater 2-2 attached to the Nitinol 2-1 is in contact with and covers the outer surface of the dura mater opening.
  • the circumferences of the Nitinol 2-1 and dura mater 2-2 are both larger than the circumference of the dura mater opening. long.
  • the outer edge of the dural opening is clamped between the inner support assembly 1 and the outer compression assembly 2.
  • the dural patch 1-2 and the gelatin sponge 1-1 can be bonded by a biological protein glue to increase the structural strength.
  • the dural patch can be type I collagen material or pericardium material or polylactic acid material or expanded polytetrafluoroethylene or silk fibroin or medical polyester film or artificial synthetic repair material or any other Used as a material for dural patch.
  • the dural patch can be any one or a combination of the following materials:
  • DURAGEN Integra LifeSciences' DURAGEN dural repair material, DURAGEN is processed and produced from bovine Achilles tendon, which is considered to be the purest source of type I collagen commercially available;
  • Patent CN2418880Y mentioned a kind of absorbable composite layer structure material for dural defect repair, which is made of polylactic acid as raw material woven into polylactic acid fabric, and a layer containing glycerin and norfloxacin is coated on one side of the fabric A mixed solution with chitosan, an artificial dura mater that is cured into a film;
  • the composition is artificial chemical synthetic material (Vicryl and PDS foil), similar to polyester sheet;
  • the SeamDura product of Johnson & Johnson which is made of absorbable polymer synthetic material polyglycolic acid (PGA), copolymer of L-lactic acid and ⁇ -caprolactone through processing, and is a three-layer sandwich composite structure , The middle is a polyglycolic acid non-woven fabric layer, and its two sides are copolymer films of L-lactic acid and ⁇ -caprolactone;
  • BBraun’s Neuro-Patch product is made of synthetic polyester urethane

Abstract

A dura mater opening closing apparatus, comprising an inner support assembly (1), an outer pressing assembly (2), a connection assembly (3), and a package assembly (4). The package assembly (4) comprises a duct (5) structure; the inner support assembly (1), the connection assembly (3), and the outer pressing assembly (2) are disposed in the duct (5) in sequence; the inner support assembly (1) is connected to the outer pressing assembly (2) by means of the connection assembly (3). The apparatus has a simple structure and easy operations; key components are pre-placed in the package assembly (4) and can be easily taken, and the time and labor are saved.

Description

硬膜开口闭合装置Dural opening closure device 技术领域Technical field
本发明涉及一种外科手术装置,特别是涉及一种硬膜开口闭合装置,属于医疗器械领域。The invention relates to a surgical device, in particular to a dural opening closing device, which belongs to the field of medical equipment.
背景技术Background technique
神经外科手术中对于硬膜损伤一般需要缝合解剖复位,如硬脑膜和硬脊膜的损伤,但在内镜中操作时,由于内镜空间狭小,医生手动缝合的难度太大,故大部分医生采用塞填材料的方式进行修复,一般包括以下三种:1、单纯用明胶海绵进行填塞;2、医用胶水与明胶海绵结合的方式进行填塞;3、用人体脂肪进行填塞。上述方法虽然简单,但产生的问题也较多,包括:1、填塞后效果不确切,如果填塞的明胶海绵过松,可能会导致术后脑脊液复发;2、与胶水结合时需要人工设计填塞,操作较复杂;3、如果采用脂肪填塞需要增加其他部位损伤。目前市场上暂无专业工具用于硬膜缺口的填充。In neurosurgery, dura mater injuries generally need to be sutured and anatomically reset, such as dura mater and dura mater injury. However, in endoscopic operations, due to the narrow space of the endoscope, it is too difficult for doctors to manually suture, so most doctors Restoration using plugging materials generally includes the following three types: 1. Packing with gelatin sponge alone; 2. Packing with a combination of medical glue and gelatin sponge; 3. Packing with body fat. Although the above method is simple, it has many problems, including: 1. The effect after packing is not accurate. If the packed gelatin sponge is too loose, it may cause the recurrence of the cerebrospinal fluid after the operation; 2. The packing needs to be artificially designed when combined with glue. The operation is more complicated; 3. If fat packing is used, other parts of the damage need to be increased. There are currently no professional tools on the market for filling dural gaps.
发明内容Summary of the invention
为了简化硬膜闭合手术操作,本发明提供了一种操作方便的硬膜开口闭合装置。In order to simplify the dural closure operation, the present invention provides a convenient dural opening closure device.
本发明一方面提供了一种硬膜开口闭合装置,包括内支撑组件、外压紧组件、连接组件和封装组件,所述封装组件包含管道,管道内依次放置内支撑组件、连接组件和外压紧组件;One aspect of the present invention provides a hard film opening closing device, which includes an inner support component, an outer compression component, a connection component, and a packaging component. The packaging component includes a pipe. The inner support component, the connection component and the external pressure are sequentially placed in the pipe. Tight component
所述内支撑组件包含膨胀材料,在膨胀材料的作用下所述内支撑组件由第一结构径向膨胀至第二结构,所述内支撑组件在所述封装组件内保持第一结构,且第一结构状态下的内支撑组件的周长小于硬膜开口的周长;当所述内支撑组件从封装组件脱离并进入硬膜开口后径向膨胀至第二结构,第二结构状态下的内支撑组件的周长大于硬膜开口的周长,以使得内支撑组件接触并覆盖在硬膜开口的内表面;The inner support component includes an expansion material, the inner support component radially expands from a first structure to a second structure under the action of the expansion material, the inner support component maintains the first structure in the packaging component, and the first structure The perimeter of the inner support component in one structure is smaller than the perimeter of the dural opening; when the inner support component separates from the packaging component and enters the dura opening, it radially expands to the second structure, and the inner support component in the second structure state The circumference of the supporting component is greater than the circumference of the dural opening, so that the inner supporting component contacts and covers the inner surface of the dural opening;
所述外压紧组件包含记忆金属材料,在记忆金属材料的形状记忆作用下所 述外压紧组件由收缩结构恢复为展开结构;所述外压紧组件在封装组件内呈收缩结构;所述外压紧组件在脱离封装组件后恢复为展开结构,所述展开结构状态下的外压紧组件的周长大于硬膜开口的周长,以使得外压紧组件接触并覆盖在硬膜开口的外表面;The external compression component includes a memory metal material, and the external compression component is restored from a contracted structure to an expanded structure under the shape memory of the memory metal material; the external compression component is in a contracted structure in the packaging component; The external compression component returns to the expanded structure after being separated from the packaging component. The circumference of the external compression component in the expanded structure state is greater than the circumference of the dural opening, so that the external compression component contacts and covers the dural opening. The outer surface;
所述内支撑组件和外压紧组件通过所述连接组件连接,所述连接组件为线结构,所述连接组件将所述硬膜开口的外边缘夹紧在内支撑组件和外压紧组件之间。The inner support component and the outer compression component are connected by the connection component, the connection component is a wire structure, and the connection component clamps the outer edge of the dura opening between the inner support component and the outer compression component between.
进一步地,所述硬膜开口闭合装置还包括推杆,所述推杆置于所述封装组件内,并排布在所述硬膜开口闭合装置的近端,与所述外压紧组件接触,用于将外压紧组件、连接组件和内支撑组件从封装组件内推出,从而使操作更简便。Further, the dural opening closing device further includes a push rod, the push rod is placed in the packaging component, and arranged at the proximal end of the dural opening closing device, and is in contact with the outer pressing component, It is used to push out the external compression component, the connection component and the internal support component from the packaging component, thereby making the operation easier.
进一步地,所述推杆沿长度方向上标有刻度线,从而能精确控制推杆的推动距离,使所述内支撑组件与所述外压紧组件到达相应的位置,有利于装置的操作。Further, the push rod is marked with scale lines along the length direction, so that the pushing distance of the push rod can be accurately controlled, so that the inner support assembly and the outer pressing assembly reach corresponding positions, which is beneficial to the operation of the device.
进一步地,所述封装组件的远端由透明材料制成,从而便于操作者观察,进一步确认相关部件从管内脱离。Further, the distal end of the packaging assembly is made of transparent material, which is convenient for the operator to observe and further confirm that the relevant parts are separated from the tube.
在一个优选的实施例中,所述膨胀材料为明胶海绵,从而保证内支撑组件有比较好的膨胀性。In a preferred embodiment, the swelling material is gelatin sponge, so as to ensure that the inner support component has a relatively good swellability.
较佳地,所述内支撑组件为明胶海绵与硬膜补片组成的复合材料,所述明胶海绵的两侧布置硬膜补片,所述一侧的硬膜补片与硬膜开口的内表面接触,且所述硬膜补片的周长大于硬膜开口的周长,以使得硬膜补片接触并覆盖在硬膜开口的内表面。增加硬膜补片一方面增强内支撑组件与硬膜开口内表面的贴合效果,另一方面支撑明胶海绵,提高其填充强度。Preferably, the inner support component is a composite material composed of a gelatin sponge and a dural patch, the dura patch is arranged on both sides of the gelatin sponge, and the dura patch on one side and the inner dural opening Surface contact, and the circumference of the dura patch is greater than the circumference of the dura opening, so that the dura patch contacts and covers the inner surface of the dura opening. Adding the dura mater on the one hand enhances the bonding effect of the internal support component and the inner surface of the dura opening, and on the other hand supports the gelatin sponge to improve its filling strength.
进一步地,所述硬膜补片由I型胶原材料、心包膜材料、聚乳酸材料、膨体聚四氟乙烯、丝素蛋白、医用聚酯膜或人工合成修补材料中的一种或多种材料的组合材料制成。Further, the dural patch is made of one or more of type I collagen material, pericardial membrane material, polylactic acid material, expanded polytetrafluoroethylene, silk fibroin, medical polyester film or artificial synthetic repair material. Made of a combination of two materials.
优选地,所述硬膜补片由I型胶原材料、聚乳酸材料或心包膜材料中的一种或多种材料的组合材料制成。Preferably, the dural patch is made of a combination of one or more of the type I collagen material, polylactic acid material or pericardium material.
更优选地,所述硬膜补片由I型胶原材料制成。More preferably, the dural patch is made of type I collagen material.
进一步地,所述硬膜补片与所述明胶海绵通过生物蛋白胶粘贴,从而使硬膜补片与明胶海绵贴合更紧密。Further, the dura patch and the gelatin sponge are pasted by a biological protein glue, so that the dura patch and the gelatin sponge adhere more closely.
在另一个实施例中,所述外压紧组件为伞形结构,内部呈圆弧状,中间设有穿线孔与所述连接组件连接。伞形结构设计使外压紧组件与硬膜开口的外表面贴合更紧密,从而提高硬膜开口闭合效果。In another embodiment, the outer pressing component is an umbrella-shaped structure, the inside is arc-shaped, and a threading hole is provided in the middle to connect with the connecting component. The umbrella-shaped structure design makes the external compression component fit more closely with the outer surface of the dural opening, thereby improving the closing effect of the dural opening.
进一步地,所述记忆金属材料为镍钛合金。Further, the memory metal material is Nitinol.
进一步地,所述外压紧组件还包括硬膜补片,所述记忆金属材料的一侧与所述硬膜补片贴合接触,所述硬膜补片的另一侧接触并覆盖硬膜开口的外表面,且所述硬膜补片的周长大于硬膜开口的周长。增加硬膜补片使外压紧组件与硬膜开口的外表面贴合更紧密。Further, the external pressing component further includes a hard film patch, one side of the memory metal material is in contact with the hard film patch, and the other side of the hard film patch contacts and covers the hard film The outer surface of the opening, and the circumference of the dural patch is greater than the circumference of the dural opening. Adding the dura mater makes the external compression component fit more closely to the outer surface of the dura opening.
在另一个实施例中,所述线结构由弹性材料制成。在弹性材料的作用下,硬膜开口的外边缘更牢固地夹紧在内支撑组件和外压紧组件之间。In another embodiment, the thread structure is made of elastic material. Under the action of the elastic material, the outer edge of the dural opening is more firmly clamped between the inner support component and the outer compression component.
进一步地,所述线结构由羊肠线、聚乳酸类缝线、聚乙交酯类缝线、聚乙醇酸PGA缝线、聚对二氧杂环已酮缝线、蚕丝线、尼龙缝线、涤纶聚酯缝线或聚丙烯缝线中的一种或者多种的组合构成。Further, the thread structure is composed of catgut, polylactic acid suture, polyglycolide suture, polyglycolic acid PGA suture, polydioxanone suture, silk thread, nylon suture , Polyester suture or polypropylene suture or a combination of one or more.
进一步地,硬膜开口的外边缘被牢固夹紧在内支撑组件和外压紧组件之间,使得闭合的硬膜开口具有防水作用。Further, the outer edge of the dura mater opening is firmly clamped between the inner support component and the outer pressing component, so that the closed dura mater opening has a waterproof effect.
进一步地,所述内支撑组件、外压紧组件和连接组件均由生物相容性材料制成。Further, the inner supporting component, the outer pressing component and the connecting component are all made of biocompatible materials.
综上所述,本发明的有益效果为:In summary, the beneficial effects of the present invention are:
1、本发明所述的一种硬膜开口闭合装置,结构简单,操作方便。内支撑组件、连接组件和外压紧组件是预先装入封装组件中,方便取用,省时省力。1. The dural opening closing device of the present invention has simple structure and convenient operation. The inner support assembly, the connection assembly and the outer compression assembly are pre-assembled in the packaging assembly, which is convenient for access and saves time and effort.
2、本发明的外压紧组件采用记忆金属材料,在记忆金属材料的形状记忆作用下所述外压紧组件由收缩结构恢复为展开结构,从而更好地闭合硬膜开口。2. The external compression component of the present invention uses a memory metal material, and under the shape memory of the memory metal material, the external compression component is restored from a contracted structure to an expanded structure, thereby better closing the dural opening.
3、在连接组件的作用下,内支撑组件、外压紧组件与硬膜开口的贴合更紧密,效果更好。3. Under the action of the connecting component, the inner support component, the outer pressing component and the dura opening are closer to each other and the effect is better.
4、推杆沿长度方向上标有刻度线,从而能精确控制推杆的推动距离,便于操作。4. The push rod is marked with tick marks along the length direction, so that the pushing distance of the push rod can be accurately controlled, which is convenient for operation.
5、封装组件的远端由透明材料制成,便于操作者观察,进一步确认相关部件从管内脱离。5. The distal end of the package assembly is made of transparent material, which is convenient for the operator to observe and further confirm that the relevant parts are separated from the tube.
6、增加硬膜补片使内支撑组件与硬膜开口内表面贴合更紧密,同时也使外压紧组件与硬膜开口外表面贴合更紧密。6. Adding the dura mater makes the inner support component fit more closely to the inner surface of the dural opening, and at the same time makes the outer compression component fit more closely to the outer surface of the dural opening.
附图说明Description of the drawings
通过阅读下文优选实施方式的详细描述,本申请的方案和优点对于本领域普通技术人员将变得清楚明了。附图仅用于示出优选实施方式的目的,而并不认为是对本发明的限制。在附图中:By reading the detailed description of the preferred embodiments below, the solutions and advantages of the present application will become clear to those of ordinary skill in the art. The drawings are only used for the purpose of illustrating the preferred embodiments, and are not considered as a limitation to the present invention. In the attached picture:
图1为本发明实施例1的结构剖面示意图。FIG. 1 is a schematic cross-sectional view of the structure of Embodiment 1 of the present invention.
图2为实施例1的操作步骤图。FIG. 2 is a diagram of the operation steps of Embodiment 1. FIG.
图3为镍钛合金从收缩结构恢复为展开结构的示意图。Fig. 3 is a schematic diagram of the Nitinol alloy recovering from the contracted structure to the expanded structure.
图4为展开结构状态下镍钛合金的俯视图。Fig. 4 is a top view of the nickel-titanium alloy in the expanded structure state.
图5为羊肠线和明胶海绵的连接示意图。Figure 5 is a schematic diagram of the connection between catgut and gelatin sponge.
图6为本发明实施例2的结构剖面示意图。6 is a schematic cross-sectional view of the structure of Embodiment 2 of the present invention.
图7为外压紧组件的结构剖面示意图。Figure 7 is a schematic structural cross-sectional view of the external compression assembly.
图8为实施例2的操作步骤图。FIG. 8 is a diagram of the operation steps of Embodiment 2.
图9为外压紧组件从收缩结构恢复为展开结构的示意图。Fig. 9 is a schematic diagram showing the restoration of the external compression assembly from the contracted structure to the expanded structure.
图10为展开结构状态下外压紧组件的俯视图。Fig. 10 is a top view of the external pressing assembly in an unfolded configuration state.
图11为丝线和内支撑组件的连接示意图。Figure 11 is a schematic diagram of the connection between the wire and the inner support assembly.
以上各图中:1、内支撑组件;1-1、明胶海绵;1-2a、硬膜补片;1-2b、硬膜补片;2、外压紧组件;2-1、镍钛合金;2-2硬膜补片;3、连接组件;4、封装组件;5、管道;6、推杆。The above figures: 1. Internal support component; 1-1, Gelatin sponge; 1-2a, dura mater; 1-2b, dura mater; 2. External compression component; 2-1, Nitinol 2-2 Hard film patch; 3. Connecting components; 4. Encapsulating components; 5. Pipes; 6. Push rods.
具体实施方式detailed description
下面将结合附图更详细地描述本公开的示例性实施方式。需要说明,提供这些实施方式是为了能够更透彻地理解本公开,并且能够将本公开的范围完整的传达给本领域的技术人员,可以以各种形式实现本公开,而不应被这里阐述的实施方式所限制。Hereinafter, exemplary embodiments of the present disclosure will be described in more detail with reference to the accompanying drawings. It should be noted that these embodiments are provided for a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art. The present disclosure can be implemented in various forms, which should not be described here. Limited by implementation.
在本申请的描述中,需要说明的是,术语“内”、“外”、“顶”、“底”、“上”、“下”等指示的方位或位置关系为基于附图所示的位置关系,仅是为了便于描述本申请中要求保护的技术方案和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本申请中要求保护的技术方案的限制In the description of this application, it should be noted that the directions or positional relationships indicated by the terms "inner", "outer", "top", "bottom", "upper", "lower", etc. are based on the drawings shown The positional relationship is only for the convenience of describing the technical solution claimed in this application and simplified description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a reference to this Limitations of the technical solution claimed in the application
在本申请的描述中,“线结构”包含任何成线状结构的情况,在一种实施例中可以是线,在另一种实施例中可以是棒,优选的情况是由弹性材料制成,在弹性材料的作用,这些线结构可以有一定的回弹力,可以更好地辅助内支撑组件和外压紧组件来闭合硬膜开口。In the description of this application, "wire structure" includes any case of a linear structure, in one embodiment it can be a wire, in another embodiment it can be a rod, preferably made of elastic material In the role of elastic materials, these line structures can have a certain resilience, which can better assist the inner support component and the outer compression component to close the dural opening.
实施例1Example 1
图1为硬膜开口闭合装置实施例1的结构剖面示意图,包括内支撑组件1、外压紧组件2、连接组件3和封装组件4。封装组件4包含管道5,管道内依次放置内支撑组件1、连接组件3和外压紧组件2,内支撑组件1和外压紧组件2通过连接组件3连接。其中,内支撑组件1为明胶海绵,预先将明胶海绵压缩至第一结构,如图1所示,以确保整体能装入封装组件4内,并在操作时能推入硬膜开口内,第一结构状态下的明胶海绵的周长小于硬膜开口的周长。外压紧组件2为记忆合金材料,如镍钛合金等。镍钛合金为伞形结构,内部圆弧状,中间开有穿线孔与连接组件3连接。预先将镍钛合金压缩至收缩结构,如图1所示,以确保整体能装入封装组件4内。此处连接组件3为羊肠线。优选地,封装组件4的远端可以是由透明材料制成。1 is a schematic structural cross-sectional view of Embodiment 1 of the dural opening closing device, which includes an inner support component 1, an outer compression component 2, a connection component 3 and a packaging component 4. The packaging component 4 includes a pipe 5 in which an inner supporting component 1, a connecting component 3 and an outer pressing component 2 are placed in sequence, and the inner supporting component 1 and the outer pressing component 2 are connected by the connecting component 3. Among them, the inner support component 1 is a gelatin sponge, and the gelatin sponge is compressed to the first structure in advance, as shown in Figure 1, to ensure that the whole can be fitted into the packaging component 4 and can be pushed into the dural opening during operation. The circumference of the gelatin sponge in a structural state is smaller than the circumference of the dural opening. The external pressing component 2 is made of a memory alloy material, such as Nitinol. The nickel-titanium alloy has an umbrella-shaped structure with a circular arc inside, and a threading hole is opened in the middle to connect with the connecting assembly 3. The nickel-titanium alloy is pre-compressed to a shrinkage structure, as shown in FIG. Here, the connecting component 3 is catgut. Preferably, the distal end of the packaging assembly 4 may be made of a transparent material.
硬膜开口闭合装置还可以包括推杆,操作时将推杆置于所述封装组件4内,并排布在硬膜开口闭合装置的近端,与所述外压紧组件2接触,用于将外压紧组件2、连接组件3和内支撑组件1从封装组件4内推出,该推杆沿长度方向上标有刻度线。需要说明的是,硬膜开口闭合装置也可以不包括推杆,使用过程中只需要采用合适的工具,例如腔镜下手术器械,即可将外压紧组件2、连接组件3和内支撑组件1从封装组件4内推出,从而完成硬膜的闭合修补。The dural opening closure device may also include a push rod. During operation, the push rod is placed in the packaging assembly 4 and arranged at the proximal end of the dural opening closure device to contact the external pressing assembly 2 for The outer pressing component 2, the connecting component 3 and the inner supporting component 1 are pushed out from the packaging component 4, and the push rod is marked with a scale line along the length direction. It should be noted that the dural opening closure device may not include a push rod. During use, only suitable tools, such as endoscopic surgical instruments, can be used to press the outer compression assembly 2, the connection assembly 3 and the inner support assembly. 1 Push out from the package assembly 4 to complete the closed repair of the hard film.
图2为硬膜开口闭合装置的操作步骤图,将硬膜开口闭合装置放置在硬膜开口上,通过推杆将管内的明胶海绵、羊肠线和镍钛合金向管外推,借助推杆上的刻度线,先将明胶海绵精确地推入硬膜开口内,明胶海绵吸水后由第一结构径向膨胀至第二结构,此时,膨胀的明胶海绵接触并覆盖在硬膜开口的内表面,明胶海绵的周长大于硬膜开口的周长。再将镍钛合金和羊肠线从管内推出,观察刻度线或者透明材料制成的封装组件远端,进一步确认相关部件从管内脱离。由于镍钛合金为记忆合金材料,镍钛合金在脱离封装组件4且没有任何外力干预的情况下由收缩结构恢复为展开结构,展开结构状态下的镍钛合金接触 并覆盖在硬膜开口的外表面,镍钛合金的周长大于硬膜开口的周长。同时,在羊肠线的作用下,硬膜开口的外边缘牢固地夹紧在明胶海绵和镍钛合金之间,从而闭合硬膜开口,闭合的硬膜开口具有防水修护作用。Figure 2 is a diagram of the operation steps of the dural opening closure device. The dural opening closure device is placed on the dural opening, and the gelatin sponge, catgut and nickel-titanium alloy in the tube are pushed out of the tube through the push rod. On the graduation line, first accurately push the gelatin sponge into the dural opening. After absorbing water, the gelatin sponge expands radially from the first structure to the second structure. At this time, the expanded gelatin sponge touches and covers the inner dural opening. On the surface, the circumference of the gelatin sponge is greater than the circumference of the dural opening. Then push the nickel-titanium alloy and catgut from the tube, observe the scale line or the distal end of the package assembly made of transparent material, and further confirm that the relevant parts are separated from the tube. Since Nitinol is a memory alloy material, the Nitinol alloy is restored from the contracted structure to the expanded structure without any external force intervention. The Nitinol in the expanded structure contacts and covers the outside of the hard film opening. On the surface, the circumference of the Nitinol alloy is greater than the circumference of the hard film opening. At the same time, under the action of the catgut, the outer edge of the dural opening is firmly clamped between the gelatin sponge and the nickel-titanium alloy, thereby closing the dural opening, and the closed dural opening has a waterproof and repairing effect.
图3为镍钛合金从收缩结构恢复为展开结构的示意图。如图所示,镍钛合金在封装组件内呈收缩结构,镍钛合金在脱离封装组件后,在记忆金属材料的形状记忆作用下逐渐恢复为展开结构,展开结构状态下的镍钛合金接触并覆盖在硬膜开口的外表面,镍钛合金的周长大于硬膜开口的周长。展开结构状态下镍钛合金的俯视图如图4所示,此时镍钛合金的结构为伞形结构。Fig. 3 is a schematic diagram of the Nitinol alloy recovering from the contracted structure to the expanded structure. As shown in the figure, the nickel-titanium alloy presents a contraction structure in the package assembly. After the nickel-titanium alloy is separated from the package assembly, it gradually returns to the expanded structure under the shape memory of the memory metal material. The nickel-titanium alloy in the expanded structure contacts and Covering the outer surface of the hard film opening, the perimeter of the nickel-titanium alloy is greater than the perimeter of the hard film opening. The top view of the nickel-titanium alloy in the unfolded state is shown in FIG. 4, and the structure of the nickel-titanium alloy at this time is an umbrella structure.
图5为羊肠线和明胶海绵的连接示意图。如图所示,羊肠线数量为2根,羊肠线从明胶海绵底部穿出并再次穿入,对明胶海绵起固定和支撑作用,部分羊肠线置于明胶海绵底部的外表面。在明胶海绵、羊肠线与镍钛合金从封装组件中脱离后,明胶海绵在硬膜开口内由第一结构径向膨胀至第二结构,镍钛合金在记忆金属材料的形状记忆作用下由收缩结构恢复为展开结构,明胶海绵和镍钛合金通过羊肠线连接,在羊肠线的限制下,膨胀的明胶海绵接触并覆盖在硬膜开口的内表面,明胶海绵的周长大于硬膜开口的周长,镍钛合金接触并覆盖在硬膜开口的外表面,镍钛合金的周长大于硬膜开口的周长。硬膜开口的外边缘夹紧在明胶海绵和镍钛合金之间。Figure 5 is a schematic diagram of the connection between catgut and gelatin sponge. As shown in the figure, the number of catgut is two. The catgut passes through the bottom of the gelatin sponge and penetrates again to fix and support the gelatin sponge. Part of the catgut is placed on the outer surface of the bottom of the gelatin sponge. After the gelatin sponge, catgut and nickel-titanium alloy are separated from the package assembly, the gelatin sponge radially expands from the first structure to the second structure in the dura opening. The nickel-titanium alloy undergoes the shape memory of the memory metal material. The contracted structure is restored to the expanded structure. The gelatin sponge and the nickel-titanium alloy are connected by the catgut. Under the restriction of the catgut, the expanded gelatin sponge contacts and covers the inner surface of the dural opening. The circumference of the gelatin sponge is larger than the dura mater. The perimeter of the opening is in contact with and covers the outer surface of the hard film opening with Nitinol, and the perimeter of the Nitinol alloy is greater than the perimeter of the hard film opening. The outer edge of the dural opening is clamped between the gelatin sponge and Nitinol.
需要指出的是,本实施例中线结构为羊肠线,在其他实施例中可以为羊肠线或聚乳酸类缝线或聚乙交酯类缝线或聚乙醇酸PGA缝线或聚对二氧杂环已酮缝线或蚕丝线或尼龙缝线或涤纶聚酯缝线或聚丙烯缝线或其他任何可以用作线结构的材料。It should be pointed out that the thread structure in this embodiment is catgut, in other embodiments it can be catgut or polylactic acid suture or polyglycolide suture or polyglycolic acid PGA suture or polypara-2 Oxyhexanone sutures or silk threads or nylon sutures or polyester sutures or polypropylene sutures or any other material that can be used as a thread structure.
实施例2Example 2
图6为硬膜开口闭合装置实施例2的结构剖面示意图,包括内支撑组件1、外压紧组件2、连接组件3、封装组件4和推杆6。封装组件4包含管道5,管道内依次放置内支撑组件1、连接组件3和外压紧组件2,内支撑组件1和外压紧组件2通过连接组件3连接。其中,内支撑组件1为明胶海绵1-1与硬膜补片(1-2a和1-2b)组成的复合材料,明胶海绵1-1的两侧分别布置硬膜补片1-2a和1-2b,由于硬膜补片不是膨胀材料,预先将明胶海绵1-1压缩至第一结构,如图6所示,以确保整体能装入封装组件4内,并在操作时能推入硬膜开口内, 第一结构状态下的明胶海绵1-1的周长小于硬膜开口的周长。外压紧组件2为镍钛合金2-1与硬膜补片2-2组成的复合材料,镍钛合金2-1的一侧与硬膜补片2-2贴合接触,如图7所示,镍钛合金2-1为伞形结构,内部圆弧状,中间开有穿线孔与连接组件3连接。预先将镍钛合金2-1压缩至收缩结构,如图6所示,以确保整体能装入封装组件4内。连接组件3为丝线,由弹性材料制成。封装组件4的远端由透明材料制成。操作时将推杆6置于所述封装组件4内,并排布在硬膜开口闭合装置的近端,与所述外压紧组件2接触,用于将外压紧组件2、连接组件3和内支撑组件1从封装组件4内推出,优选地,该推杆6沿长度方向上标有刻度线。6 is a schematic structural cross-sectional view of Embodiment 2 of the dural opening closure device, which includes an inner support assembly 1, an outer compression assembly 2, a connection assembly 3, a packaging assembly 4 and a push rod 6. The packaging component 4 includes a pipe 5 in which an inner supporting component 1, a connecting component 3 and an outer pressing component 2 are placed in sequence, and the inner supporting component 1 and the outer pressing component 2 are connected by the connecting component 3. Among them, the inner support component 1 is a composite material composed of a gelatin sponge 1-1 and a dural patch (1-2a and 1-2b). The two sides of the gelatin sponge 1-1 are arranged with dural patch 1-2a and 1 respectively. -2b. Since the hard film patch is not an swelling material, the gelatin sponge 1-1 is compressed into the first structure in advance, as shown in Figure 6, to ensure that the whole can be installed in the package assembly 4 and can be pushed into the hard film during operation. In the membrane opening, the circumference of the gelatin sponge 1-1 in the first structure state is smaller than the circumference of the dural opening. The external compression component 2 is a composite material composed of Nitinol 2-1 and the hard film patch 2-2. One side of the Nitinol 2-1 is in contact with the hard film patch 2-2, as shown in Figure 7. As shown, the nickel-titanium alloy 2-1 has an umbrella-shaped structure with a circular arc shape inside, and a threading hole is opened in the middle to connect with the connecting assembly 3. The Nitinol 2-1 is pre-compressed to a shrinkage structure, as shown in FIG. 6, to ensure that the whole can be installed in the package assembly 4. The connecting component 3 is a wire made of elastic material. The distal end of the package assembly 4 is made of transparent material. During operation, the push rod 6 is placed in the packaging assembly 4, and arranged at the proximal end of the dural opening closing device, and is in contact with the external pressing assembly 2 for connecting the external pressing assembly 2, the connecting assembly 3 and The inner support assembly 1 is pushed out from the packaging assembly 4. Preferably, the push rod 6 is marked with scale lines along the length direction.
图8为硬膜开口闭合装置的操作步骤图,将硬膜开口闭合装置放置在硬膜开口上,通过推杆6将管内的内支撑组件1、丝线和外压紧组件2向管外推,借助推杆6上的刻度线,先将内支撑组件1精确地推入硬膜开口内,明胶海绵1-1吸水后由第一结构径向膨胀至第二结构,此时,明胶海绵1-1的周长大于硬膜开口的周长,上侧的硬膜补片1-2a被支撑,且硬膜补片1-2a的周长大于硬膜开口的周长,以使得硬膜补片1-2a接触并覆盖在硬膜开口的内表面。再将外压紧组件2和丝线从管内推出,观察透明材料制成的封装组件远端,进一步确认相关部件从管内脱离。由于镍钛合金2-1为记忆合金材料,镍钛合金2-1在脱离封装组件4且没有任何外力干预的情况下由收缩结构恢复为展开结构,与镍钛合金2-1贴合的硬膜补片2-2接触并覆盖在硬膜开口的外表面,镍钛合金2-1和硬膜补片2-2的周长均大于硬膜开口的周长。同时,在丝线的作用下,硬膜开口的外边缘牢固地夹紧在内支撑组件1和外压紧组件2之间,从而闭合硬膜开口,闭合的硬膜开口具有防水修护作用。Figure 8 is a diagram of the operation steps of the dural opening closure device. The dural opening closure device is placed on the dural opening, and the inner support assembly 1, the silk thread and the outer compression assembly 2 in the tube are pushed out of the tube through the push rod 6. With the help of the scale line on the push rod 6, the inner support assembly 1 is accurately pushed into the dural opening. After the gelatin sponge 1-1 absorbs water, it expands radially from the first structure to the second structure. At this time, the gelatin sponge 1- The circumference of 1 is greater than the circumference of the dural opening, the upper dural patch 1-2a is supported, and the circumference of the dural patch 1-2a is greater than the circumference of the dural opening, so that the dural patch 1-2a touches and covers the inner surface of the dural opening. Then push the outer compression assembly 2 and the wire out of the tube, observe the distal end of the package assembly made of transparent material, and further confirm that the relevant parts are separated from the tube. As Nitinol 2-1 is a memory alloy material, Nitinol 2-1 recovers from a contraction structure to an unfolded structure without any external force intervention when it is separated from the package assembly 4, and is hard bonded to Nitinol 2-1. The dura mater 2-2 contacts and covers the outer surface of the dura mater opening, and the perimeters of the nickel-titanium alloy 2-1 and the dura mater patch 2-2 are both greater than the perimeter of the dura mater opening. At the same time, under the action of the silk thread, the outer edge of the dural opening is firmly clamped between the inner support component 1 and the outer pressing component 2 to close the dural opening, and the closed dural opening has a waterproof repair function.
图9为外压紧组件2从收缩结构恢复为展开结构的示意图。如图所示,外压紧组件2在封装组件内呈收缩结构,外压紧组件2在脱离封装组件后,在记忆金属材料的形状记忆作用下逐渐恢复为展开结构,与镍钛合金2-1贴合的硬膜补片2-2接触并覆盖在硬膜开口的外表面,镍钛合金2-1和硬膜补片2-2的周长均大于硬膜开口的周长。展开结构状态下外压紧组件2的俯视图如图10所示,此时外压紧组件2的结构为伞形结构。FIG. 9 is a schematic diagram of the external compression assembly 2 returning from the contracted structure to the expanded structure. As shown in the figure, the external compression component 2 is in a contracted structure inside the packaging component. After the external compression component 2 is separated from the packaging component, it gradually returns to the expanded structure under the shape memory of the memory metal material. 1. The attached dural patch 2-2 contacts and covers the outer surface of the dural opening. The perimeters of the Nitinol 2-1 and the dural patch 2-2 are both larger than the perimeter of the dural opening. The top view of the outer pressing assembly 2 in the expanded structure state is shown in FIG. 10, and the structure of the outer pressing assembly 2 at this time is an umbrella structure.
图10为丝线和内支撑组件1的连接示意图。如图所示,丝线数量为2根,丝线从硬膜补片1-2b底部穿出并再次穿入,对内支撑组件1起固定和支撑作用, 部分丝线置于硬膜补片1-2b底部的外表面。在内支撑组件1、丝线与外压紧组件2从封装组件中脱离后,明胶海绵1-1在硬膜开口内由第一结构径向膨胀至第二结构,镍钛合金2-1在记忆金属材料的形状记忆作用下由收缩结构恢复为展开结构,内支撑组件1和外压紧组件2通过丝线连接,在丝线的限制下,上侧的硬膜补片1-2a被膨胀的明胶海绵支撑,且硬膜补片1-2a的周长大于硬膜开口的周长,以使得硬膜补片1-2a接触并覆盖在硬膜开口的内表面。与镍钛合金2-1贴合的硬膜补片2-2接触并覆盖在硬膜开口的外表面,镍钛合金2-1和硬膜补片2-2的周长均大于硬膜开口的周长。硬膜开口的外边缘夹紧在内支撑组件1和外压紧组件2之间。优选地,硬膜补片1-2与明胶海绵1-1可通过生物蛋白胶粘接,以增加结构强度。FIG. 10 is a schematic diagram of the connection between the wire and the inner support assembly 1. As shown in the figure, the number of silk threads is 2. The silk threads are threaded out from the bottom of the dural patch 1-2b and inserted again to fix and support the inner support component 1. Part of the silk threads are placed on the dural patch 1-2b The outer surface of the bottom. After the inner support assembly 1, the wire and the outer compression assembly 2 are separated from the package assembly, the gelatin sponge 1-1 expands radially from the first structure to the second structure in the hard film opening, and the nickel titanium alloy 2-1 is in the memory Under the action of the shape memory of the metal material, the contracted structure is restored to the expanded structure. The inner support assembly 1 and the outer compression assembly 2 are connected by a silk thread. Under the restriction of the silk thread, the upper dural patch 1-2a is expanded by the gelatin sponge Support, and the circumference of the dural patch 1-2a is greater than the circumference of the dural opening, so that the dural patch 1-2a contacts and covers the inner surface of the dural opening. The dura mater 2-2 attached to the Nitinol 2-1 is in contact with and covers the outer surface of the dura mater opening. The circumferences of the Nitinol 2-1 and dura mater 2-2 are both larger than the circumference of the dura mater opening. long. The outer edge of the dural opening is clamped between the inner support assembly 1 and the outer compression assembly 2. Preferably, the dural patch 1-2 and the gelatin sponge 1-1 can be bonded by a biological protein glue to increase the structural strength.
在本实施例中,硬膜补片可以是I型胶原材料或心包膜材料或聚乳酸材料或膨体聚四氟乙烯或丝素蛋白或医用聚酯膜或人工合成修补材料或其他任何可以用作硬膜补片的材料。例如,硬膜补片可以是以下任意一种或多种材料的组合:In this embodiment, the dural patch can be type I collagen material or pericardium material or polylactic acid material or expanded polytetrafluoroethylene or silk fibroin or medical polyester film or artificial synthetic repair material or any other Used as a material for dural patch. For example, the dural patch can be any one or a combination of the following materials:
1.Integra LifeSciences公司的DURAGEN硬膜修补材料,DURAGEN由牛跟腱加工生产而成,牛跟腱被认为是商业上可获得的最纯净的Ⅰ型胶原来源;1. Integra LifeSciences' DURAGEN dural repair material, DURAGEN is processed and produced from bovine Achilles tendon, which is considered to be the purest source of type I collagen commercially available;
2.专利CN2418880Y中提及的一种硬脑膜缺损修复用的可吸收的复合层结构材料,是聚乳酸为原料编织成聚乳酸织物,在织物的一面涂敷一层含有甘油、诺氟沙星与壳聚糖的混合溶液,经固化成膜的人工硬脑膜材料;2. Patent CN2418880Y mentioned a kind of absorbable composite layer structure material for dural defect repair, which is made of polylactic acid as raw material woven into polylactic acid fabric, and a layer containing glycerin and norfloxacin is coated on one side of the fabric A mixed solution with chitosan, an artificial dura mater that is cured into a film;
3.Baxter公司的PEG涂层胶原蛋白垫片;3. Baxter's PEG coated collagen gasket;
4.Takeda Austria GmbH公司的TachoSil硬膜密封剂;4. TachoSil hard film sealant from Takeda Austria GmbH;
5.天义福公司的DuraMax产品,成分是牛肌腱I型胶原;5. Tianyifu's DuraMax product, the ingredient is bovine tendon type I collagen;
6.冠昊公司的NormalGen产品,成分是猪源心包膜;6. Guanhao's NormalGen product, the ingredient is pig-derived pericardium;
7.佰仁思公司的Dura Scaffold产品,成分是牛心包膜;7. The Dura Scaffold product of Bairensi Company, the ingredient is bovine pericardium;
8.Synovis公司的Dura-Guard产品,成分是经戊二醛处理的牛心包膜;8. The Dura-Guard product of Synovis, the ingredient is bovine pericardium treated with glutaraldehyde;
9.强生公司的Ethisorb产品,成分是人工化学合成材料(Vicryl and PDS foil),类似聚酯类薄片;9. Johnson & Johnson's Ethisorb product, the composition is artificial chemical synthetic material (Vicryl and PDS foil), similar to polyester sheet;
10.强生公司的SeamDura产品,它是由可吸收性高分子合成材料聚乙醇酸(PGA),L-乳酸和ε-己内酯的共聚物经加工制成,为三层的三明治式复合结构,中间为聚乙醇酸无纺布层,其两侧面为L-乳酸和ε-己内酯的共聚物膜;10. The SeamDura product of Johnson & Johnson, which is made of absorbable polymer synthetic material polyglycolic acid (PGA), copolymer of L-lactic acid and ε-caprolactone through processing, and is a three-layer sandwich composite structure , The middle is a polyglycolic acid non-woven fabric layer, and its two sides are copolymer films of L-lactic acid and ε-caprolactone;
11.BBraun公司的Neuro-Patch产品,成分是聚酯尿烷(polyester urethane)人工合成材料;11. BBraun’s Neuro-Patch product is made of synthetic polyester urethane;
12.Gore公司的Preclude产品,由膨体聚四氟乙烯制成。12. Gore's Preclude product is made of expanded polytetrafluoroethylene.
以上所述,仅为本发明较佳的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到的变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以所述权利要求的保护范围为准。The above are only preferred specific embodiments of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or changes within the technical scope disclosed by the present invention. All replacements shall be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims (14)

  1. 一种硬膜开口闭合装置,其特征在于:包括内支撑组件、外压紧组件、连接组件和封装组件,所述封装组件包含管道,管道内依次放置内支撑组件、连接组件和外压紧组件;A hard film opening closing device, which is characterized in that it comprises an inner support component, an outer compression component, a connection component, and a packaging component. The packaging component includes a pipe. The inner support component, the connection component and the outer compression component are sequentially placed in the pipe ;
    所述内支撑组件包含膨胀材料,在膨胀材料的作用下所述内支撑组件由第一结构径向膨胀至第二结构,所述内支撑组件在所述封装组件内保持第一结构,且第一结构状态下的内支撑组件的周长小于硬膜开口的周长;当所述内支撑组件从封装组件脱离并进入硬膜开口后径向膨胀至第二结构,第二结构状态下的内支撑组件的周长大于硬膜开口的周长,以使得内支撑组件接触并覆盖在硬膜开口的内表面;The inner support component includes an expansion material, the inner support component radially expands from a first structure to a second structure under the action of the expansion material, the inner support component maintains the first structure in the packaging component, and the first structure The perimeter of the inner support component in one structure is smaller than the perimeter of the dural opening; when the inner support component separates from the packaging component and enters the dura opening, it radially expands to the second structure, and the inner support component in the second structure state The circumference of the supporting component is greater than the circumference of the dural opening, so that the inner supporting component contacts and covers the inner surface of the dural opening;
    所述外压紧组件包含记忆金属材料,在记忆金属材料的形状记忆作用下所述外压紧组件由收缩结构恢复为展开结构;所述外压紧组件在封装组件内呈收缩结构;所述外压紧组件在脱离封装组件后恢复为展开结构,所述展开结构状态下的外压紧组件的周长大于硬膜开口的周长,以使得外压紧组件接触并覆盖在硬膜开口的外表面;The external compression component includes a memory metal material, and the external compression component is restored from a contracted structure to an expanded structure under the shape memory of the memory metal material; the external compression component is in a contracted structure in the packaging component; The external compression component returns to the expanded structure after being separated from the packaging component. The circumference of the external compression component in the expanded structure state is greater than the circumference of the dural opening, so that the external compression component contacts and covers the dural opening. The outer surface;
    所述内支撑组件和外压紧组件通过所述连接组件连接,所述连接组件为线结构,所述连接组件将所述硬膜开口的外边缘夹紧在内支撑组件和外压紧组件之间。The inner support component and the outer compression component are connected by the connection component, the connection component is a wire structure, and the connection component clamps the outer edge of the dura opening between the inner support component and the outer compression component between.
  2. 根据权利要求1所述的硬膜开口闭合装置,其特征在于,还包括推杆,所述推杆置于所述封装组件内,并排布在所述硬膜开口闭合装置的近端,与所述外压紧组件接触,用于将外压紧组件、连接组件和内支撑组件从封装组件内推出。The dural opening closure device according to claim 1, further comprising a push rod, the push rod is placed in the packaging component and arranged at the proximal end of the dural opening closure device, and The contact of the outer pressing component is used to push the outer pressing component, the connecting component and the inner supporting component out of the packaging component.
  3. 根据权利要求2所述的硬膜开口闭合装置,其特征在于,所述推杆沿长度方向上标有刻度线。The dural opening closure device according to claim 2, wherein the push rod is marked with a scale line along the length direction.
  4. 根据权利要求1所述的硬膜开口闭合装置,其特征在于,所述膨胀材料为明胶海绵。The dural opening closure device of claim 1, wherein the swelling material is gelatin sponge.
  5. 根据权利要求1所述的硬膜开口闭合装置,其特征在于,所述内支撑组件为明胶海绵与硬膜补片组成的复合材料,所述明胶海绵的两侧布置硬膜补片,所述一侧的硬膜补片与硬膜开口的内表面接触,且所述硬膜补片的周长大于硬膜开口的周长,以使得硬膜补片接触并覆盖在硬膜开口的内表面。The dural opening closure device according to claim 1, wherein the inner support component is a composite material composed of a gelatin sponge and a dura patch, and the dura patch is arranged on both sides of the gelatin sponge, and the The dural patch on one side is in contact with the inner surface of the dural opening, and the perimeter of the dural patch is greater than the perimeter of the dural opening, so that the dural patch contacts and covers the inner surface of the dural opening .
  6. 根据权利要求5所述的硬膜开口闭合装置,其特征在于,所述硬膜补片由I型胶原材料、心包膜材料、聚乳酸材料、膨体聚四氟乙烯、丝素蛋白、医用聚酯膜 或人工合成修补材料中的一种或多种材料的组合材料制成。The dural opening closure device according to claim 5, wherein the dural patch is made of type I collagen material, pericardium material, polylactic acid material, expanded polytetrafluoroethylene, silk fibroin, medical It is made of a combination of one or more materials in polyester film or artificial synthetic repair materials.
  7. 根据权利要求5所述的硬膜开口闭合装置,其特征在于,所述硬膜补片与所述明胶海绵通过生物蛋白胶粘贴。The dural opening closure device according to claim 5, wherein the dural patch and the gelatin sponge are pasted by a biological protein glue.
  8. 根据权利要求1所述的硬膜开口闭合装置,其特征在于,所述外压紧组件为伞形结构,内部呈圆弧状,中间设有穿线孔与所述连接组件连接。The dural opening closure device according to claim 1, wherein the outer compression component is an umbrella-shaped structure, the inside is arc-shaped, and a threading hole is provided in the middle to connect with the connecting component.
  9. 根据权利要求1所述的硬膜开口闭合装置,其特征在于,所述记忆金属材料为镍钛合金。The dural opening closure device according to claim 1, wherein the memory metal material is Nitinol.
  10. 根据权利要求1所述的硬膜开口闭合装置,其特征在于,所述外压紧组件还包括硬膜补片,所述记忆金属材料的一侧与所述硬膜补片贴合接触,所述硬膜补片的另一侧接触并覆盖硬膜开口的外表面,且所述硬膜补片的周长大于硬膜开口的周长。The dural opening closure device according to claim 1, wherein the external pressing component further comprises a dura patch, one side of the memory metal material is in contact with the dura patch, so The other side of the dural patch contacts and covers the outer surface of the dural opening, and the circumference of the dural patch is greater than the circumference of the dural opening.
  11. 根据权利要求1所述的硬膜开口闭合装置,其特征在于,所述线结构由弹性材料制成。The dural opening closure device according to claim 1, wherein the thread structure is made of elastic material.
  12. 根据权利要求1所述的硬膜开口闭合装置,其特征在于,所述线结构为羊肠线、聚乳酸类缝线、聚乙交酯类缝线、聚乙醇酸PGA缝线、聚对二氧杂环已酮缝线、蚕丝线、尼龙缝线、涤纶聚酯缝线或聚丙烯缝线中的一种或者多种的组合。The dural opening closure device according to claim 1, wherein the thread structure is catgut, polylactic acid suture, polyglycolide suture, polyglycolic acid PGA suture, polypara 2 One or a combination of oxanone sutures, silk threads, nylon sutures, polyester sutures or polypropylene sutures.
  13. 根据权利要求1所述的硬膜开口闭合装置,其特征在于,所述内支撑组件、外压紧组件和连接组件均由生物相容性材料制成。The dural opening closure device according to claim 1, wherein the inner supporting component, the outer pressing component and the connecting component are all made of biocompatible materials.
  14. 根据权利要求1所述的硬膜开口闭合装置,其特征在于,所述封装组件的远端由透明材料制成。The dural opening closure device according to claim 1, wherein the distal end of the packaging component is made of a transparent material.
PCT/CN2019/112815 2019-08-19 2019-10-23 Dura mater opening closing apparatus WO2021031332A1 (en)

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CN116869593B (en) * 2023-09-06 2023-11-28 北京大学人民医院 Dura mater closer

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WO2009064839A1 (en) * 2007-11-13 2009-05-22 Cook Biotech Incorporated Fistula grafts and related methods and systems useful for treating gastrointestinal and other fistulae
RU2570619C1 (en) * 2014-05-22 2015-12-10 Анастасия Игоревна Рябова Method for repairing extensive defect of bottom of anterior cranial fossa
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