CN107260234B - Woven degradable plugging device - Google Patents

Woven degradable plugging device Download PDF

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Publication number
CN107260234B
CN107260234B CN201710461377.0A CN201710461377A CN107260234B CN 107260234 B CN107260234 B CN 107260234B CN 201710461377 A CN201710461377 A CN 201710461377A CN 107260234 B CN107260234 B CN 107260234B
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China
Prior art keywords
plugging device
connecting structure
woven
wire
occluder
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CN201710461377.0A
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Chinese (zh)
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CN107260234A (en
Inventor
潘湘斌
李博
曾凡艳
杨永森
陈娟
蒲忠杰
王广卉
张红梅
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Shanghai Shape Memory Alloy Material Co Ltd
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Shanghai Shape Memory Alloy Material Co Ltd
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Priority to CN201710461377.0A priority Critical patent/CN107260234B/en
Publication of CN107260234A publication Critical patent/CN107260234A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00796Breast surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties

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

Abstract

The invention discloses a woven degradable plugging device which comprises a wire woven mesh, and a far end tip and a near end tip which are respectively arranged at two ends of the wire woven mesh. The woven degradable occluder is completely degradable, has better long-term effect on patients, and avoids occluder complications induced by other long-term diseases; the cutting pipe is hooked by a plurality of parts, so that the shape of the occluder is kept in an I shape, the occluder is better attached to the defect, and the stability and the occlusion property of the occluder in the defect are ensured; the design of the auxiliary line can play a role in safety, and the auxiliary line can be used for recycling when the occluder falls off, so that serious complications are avoided.

Description

Woven degradable plugging device
Technical Field
The invention relates to a woven degradable plugging device, and belongs to the technical field of medical instruments.
Background
At present, the occluder is in a mushroom umbrella shape made of nickel-titanium shape memory alloy and is widely applied clinically. But the potential risks are as follows:
1. the occluder is implanted in the heart for a long time, and if the peripheral blood vessels are subjected to swelling lesion, the occluder can abrade the surrounding tissues to cause other diseases such as rupture of an arterial interlayer;
2. as the patients grow up, part of the patients have a certain probability of generating long-term three-degree conduction block;
3. ni ion allergy is found after operation of a few patients, and the plugging device is not tolerant, so other problems can be caused;
disclosure of Invention
The technical problem to be solved by the invention is as follows: the woven degradable occluder is good in stability and occlusion performance and capable of avoiding serious complications, and solves the problems that the existing occluder can abrade surrounding tissues, so that a patient generates a long-term three-degree conduction block and the occluder cannot bear the resistance.
In order to solve the technical problems, the technical scheme of the invention is to provide a woven degradable plugging device which comprises a wire woven mesh, and a far end tip and a near end tip which are respectively arranged at two ends of the wire woven mesh.
Preferably, the connecting structure comprises at least 2 connecting rods, and each connecting rod penetrates through the grid gaps of the wire woven mesh to be connected with the near-end tip or the wire woven mesh around the near-end tip.
Preferably, the connecting structure comprises 2-6 connecting rods.
Preferably, the connecting structure is a cut tube or a bent wire; the upper end of the cutting pipe is connected with the far-end, and the lower end of the cutting pipe is provided with a connecting rod which is uniformly split; the bent wire includes a connecting rod.
Preferably, when each connecting rod is connected with the proximal end head, each connecting rod is folded towards the axial direction of the connecting structure.
Preferably, when each connecting rod is connected with the wire mesh grid around the proximal end, the head end of each connecting rod is provided with one or two hooks.
Preferably, when the head end of each connecting rod is provided with a hook, each connecting rod is folded towards the axial direction of the connecting structure.
Preferably, the far-end is provided with a ligation sleeve, and the wire mesh grid comprises a plate surface and a waist connected with the plate surface.
Preferably, the material of the connecting structure is degradable material or metal material.
Preferably, the degradable material is polylactic acid, polydioxanone, PLGA; the metal material is nickel-titanium alloy or cobalt-chromium alloy.
The woven degradable occluder is completely degradable, has better long-term effect on patients, and avoids occluder complications induced by other long-term diseases; the cutting pipe is hooked by a plurality of parts, so that the shape of the occluder is kept in an I shape, the occluder is better attached to the defect, and the stability and the occlusion property of the occluder in the defect are ensured; the design of the auxiliary line can play a role in safety, and the auxiliary line can be used for recycling when the occluder falls off, so that serious complications are avoided.
Drawings
Fig. 1 is a schematic structural diagram (1) of a woven degradable plugging device when the connecting structure is a pipe cutting structure;
FIG. 2 is a schematic structural diagram (2) of a woven degradable plugging device when the connecting structure is a pipe cutting structure;
FIG. 3 is a schematic structural diagram (3) of a woven degradable plugging device when the connecting structure is a pipe cutting structure;
FIG. 4 is a top view of a woven degradable occluder;
FIG. 5 is a schematic view of the release process of a woven degradable occluder
a. A schematic diagram before release of a woven degradable plugging device;
b. a schematic diagram of a knitted degradable occluder after release;
FIG. 6 is a schematic structural view of a woven degradable plugging device when the connection structure is a bent wire material
a. The lower end of the bent wire is provided with two bent hooks, and the structure of the woven degradable plugging device is shown schematically;
b. the lower end of the bent wire is provided with a hook, and the structure of the woven degradable plugging device is shown schematically;
c. a structural schematic diagram of a woven degradable plugging device when the bending wire is folded towards the axial direction.
Detailed Description
In order to make the invention more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings.
Example 1
Because the mechanical properties of the degradable wire material, such as superelasticity, are far weaker than those of the shape memory alloy wire material, in order to ensure that the occluder has the expected occlusion effect in clinical application, the occluder needs to be structurally compensated to a certain extent, the compensation scheme is shown in figures 1-3, a cutting pipe (namely, a connecting structure 3) is added at the upper end of the occluder, namely, the woven wire material woven mesh 2 at the far end of the woven degradable occluder, and the upper end of the cutting pipe is fixedly connected with the far end head 1.
The lower end of the cut pipe is evenly split into 4 connecting rods 3-1, as shown in figure 4, each connecting rod 3-1 is folded in the axial direction of the cut pipe, as shown in figure 1, after the occluder is released, the cut pipe is assisted by the pull-back of an auxiliary line, each connecting rod 3-1 at the lower end of the cut pipe penetrates through the grid gap of the wire mesh grid 2 and is folded in the axial direction, the proximal end 4 of the occluder is clamped, the linear distance between the two ends of the occluder is consistent with the length of the cut pipe, the occluder is stabilized in an I shape at the moment, the occluder is guaranteed not to fall off, meanwhile, the disc surface 2-1 and the waist 2-2 play a role in occlusion, and the effect of mechanical supplement is achieved.
The material for cutting the pipe can be degradable material, and the degradable material is polylactic acid, polydioxanone, PLGA and the like; the material of the cutting pipe can also be a metal material, and the metal material is nickel-titanium alloy or cobalt-chromium alloy.
As shown in a and b in fig. 5, the auxiliary wires are ensured not to be twisted together by penetrating the plugging device grids through the fine sheath in two symmetrical small cavities. The auxiliary thread passes through the meshes of the wire woven mesh 2 of the occluder and bypasses the distal end of the occluder. When the plugging device is released at a defect position, an operator tensions the auxiliary line at the joint end of the sheath tube, the auxiliary line drives the ligation sleeve 1-1 of the distal end head 1 of the plugging device and the cutting tube to move back, and the I-shaped platform of the I-shaped plugging device forms a cup shape under the condition that the auxiliary line is pulled, so that the plugging device is prevented from falling off, and the disc surface 2-1 and the waist 2-2 play a plugging effect, so that a mechanical compensation effect is realized, and the same plugging effect as the nickel-titanium shape memory alloy is realized. After the clamping position of the cut pipe is well fixed, the auxiliary thread is cut at the joint of the sheath pipe, a broken end is pulled, the auxiliary thread is pulled out of the plugging device, and finally the auxiliary thread is withdrawn along with the sheath pipe.
Example 2
As shown in figure 2, the lower end of the cut tube is evenly split into 4 connecting rods 3-1, each connecting rod 3-1 is folded towards the axial direction of the cut tube, the head end of each connecting rod 3-1 on the cut tube is provided with a hook 3-2, after the occluder is released, the cut tube passes through the mesh gaps of the wire mesh grid 2 of the occluder under the assistance of the pull-back of the auxiliary line, and is folded towards the axial direction, and simultaneously, the hook 3-2 hooks the wire/mesh of the wire mesh grid 2 near the proximal end 4 or the proximal end 4 of the occluder tightly, so that the linear distance between the two ends of the occluder is consistent with the length of the cut tube, the occluder is stabilized in an I shape at the moment, the occluder is ensured not to fall off, and simultaneously, the disc surface 2-1 and the waist 2-2 play a role in occluding, the effect of mechanical supplement is realized.
The rest is the same as in example 1.
Example 3
As shown in figure 3, the lower end of the cut pipe is evenly split into 4 connecting rods 3-1, each connecting rod 3-1 can not be folded in the axial direction of the cut pipe, one or two hooks 3-2 are arranged at the head end of the plugging device, when the plugging device is released, the cutting tube passes through the grid gap of the wire woven net 2 of the plugging device under the pull-back assistance of the auxiliary line by each connecting rod 3-1 at the lower end of the cutting tube, the hooks 3-2 hook the wires/grids of the wire woven net 2 at the near end 4 or the near end 4 of the plugging device, the linear distance between the two ends of the plugging device is consistent with the length of the cut pipe, the plugging device is stabilized in an I shape at the moment, the plugging device is ensured not to fall off, meanwhile, the disc surface 2-1 and the waist 2-2 play a role in plugging, and a mechanically supplementary effect is realized.
The rest is the same as in example 1.
Example 4
As shown in a, b and c in fig. 6, the occluder connected with the cut tube can also replace a bent wire (i.e. the connecting structure 3 is a bent wire), and the head end of the bent wire is bent, so that the expected purpose of stable hooking can be achieved.
The rest is the same as in example 1.
Example 5
In this embodiment, the cutting tube may be divided into 2 connecting rods 3-1.
The rest is the same as in example 1.
Example 6
In this embodiment, the cut tube may be divided into 6 connecting rods 3-1.
The rest is the same as in example 1.

Claims (7)

1. A woven degradable plugging device comprises a wire woven mesh (2), and a far end head (1) and a near end head (4) which are respectively arranged at two ends of the wire woven mesh (2), and is characterized in that a connecting structure (3) is arranged in the wire woven mesh (2), the upper end of the connecting structure (3) is connected with the far end head (1),
the lower end of the connecting structure (3) is evenly divided into at least 2 connecting rods (3-1), and each connecting rod (3-1) is folded towards the axial direction of the connecting structure (3); after the plugging device is released, each connecting rod (3-1) at the lower end of the connecting structure (3) penetrates through the grid gap of the wire woven net (2) and is folded in the axial direction, and the proximal end head (4) of the plugging device is clamped, so that the linear distance between the two end heads of the plugging device is consistent with the length of the connecting structure (3), and the plugging device is stable in an I shape at the moment.
2. A woven degradable plugging device comprises a wire woven mesh (2), and a far end head (1) and a near end head (4) which are respectively arranged at two ends of the wire woven mesh (2), and is characterized in that a connecting structure (3) is arranged in the wire woven mesh (2), the upper end of the connecting structure (3) is connected with the far end head (1),
the lower end of the connecting structure (3) is evenly divided into at least 2 connecting rods (3-1), each connecting rod (3-1) is folded towards the axial direction of the connecting structure (3), and the head end of each connecting rod (3-1) on the connecting structure (3) is provided with a bent hook (3-2); after the plugging device is released, each connecting rod (3-1) at the lower end of the connecting structure (3) penetrates through a grid gap of the wire woven net (2) of the plugging device and is folded towards the axis direction, and meanwhile, the bent hook (3-2) hooks the wire or the grid of the wire woven net (2) near the near-end head (4) or the near-end head (4) of the plugging device, so that the linear distance between the two end heads of the plugging device is consistent with the length of the connecting structure (3), and the plugging device is stabilized to be in an I shape at the moment.
3. The woven degradable occluder of claim 1 or 2, wherein said connecting structure (3) comprises 2-6 connecting rods (3-1).
4. The woven degradable occluder of claim 1 or 2, wherein said connecting structure (3) is a cut tube or a bent wire; the upper end of the cutting pipe is connected with the far-end (1), and the lower end of the cutting pipe is provided with a connecting rod (3-1) which is uniformly split; the bending wire comprises a connecting rod (3-1).
5. The woven degradable occluder of claim 1 or 2, wherein the distal end (1) is provided with a ligation cover (1), and the wire mesh (2) comprises a plate surface (2-1) and a waist portion (2-2) connected with the plate surface (2-1).
6. The woven degradable occluder of claim 1 or 2, wherein the material of the connecting structure (3) is degradable or metallic.
7. The woven degradable occluder of claim 6 wherein said degradable material is polylactic acid, polydioxanone, PLGA; the metal material is nickel-titanium alloy or cobalt-chromium alloy.
CN201710461377.0A 2017-06-16 2017-06-16 Woven degradable plugging device Active CN107260234B (en)

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CN107260234B true CN107260234B (en) 2020-10-09

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Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108451570A (en) * 2018-02-23 2018-08-28 上海形状记忆合金材料有限公司 Assist molding device and method in Wholly-degradable plugging device body
CN110742658B (en) * 2019-10-29 2022-09-23 中国医学科学院生物医学工程研究所 Bilateral anisotropic absorbable occluder
CN114642467A (en) * 2020-12-17 2022-06-21 先健科技(深圳)有限公司 Plugging device and plugging system
CN115153678A (en) * 2022-06-23 2022-10-11 上海傲流医疗科技有限公司 Valve clearance shutoff filler and filling mechanism

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CN204181679U (en) * 2014-10-13 2015-03-04 陈奕龙 Occluder for left auricle
CN204971378U (en) * 2015-08-12 2016-01-20 上海形状记忆合金材料有限公司 Plugging device that can degrade completely in vivo
CN106344100A (en) * 2016-10-11 2017-01-25 北京工业大学 Left auricle plugging device
CN208065211U (en) * 2017-06-16 2018-11-09 上海形状记忆合金材料有限公司 A kind of degradable plugging device of braiding

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EP1868507A1 (en) * 2005-03-18 2007-12-26 NMT Medical, Inc. Catch member for pfo occluder
WO2008124603A1 (en) * 2007-04-05 2008-10-16 Nmt Medical, Inc. Septal closure device with centering mechanism
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CN204520803U (en) * 2015-02-25 2015-08-05 上海形状记忆合金材料有限公司 Split-type degradable stopper
CN105193521B (en) * 2015-11-09 2018-06-12 柏为(武汉)医疗科技有限公司 A kind of retrievable vena cava filter with good adherence quality

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN204181679U (en) * 2014-10-13 2015-03-04 陈奕龙 Occluder for left auricle
CN204971378U (en) * 2015-08-12 2016-01-20 上海形状记忆合金材料有限公司 Plugging device that can degrade completely in vivo
CN106344100A (en) * 2016-10-11 2017-01-25 北京工业大学 Left auricle plugging device
CN208065211U (en) * 2017-06-16 2018-11-09 上海形状记忆合金材料有限公司 A kind of degradable plugging device of braiding

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