CN109431554A - A kind of interventional medicine I-shaped closer of vascular puncture mouth and preparation method thereof - Google Patents

A kind of interventional medicine I-shaped closer of vascular puncture mouth and preparation method thereof Download PDF

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Publication number
CN109431554A
CN109431554A CN201810959536.4A CN201810959536A CN109431554A CN 109431554 A CN109431554 A CN 109431554A CN 201810959536 A CN201810959536 A CN 201810959536A CN 109431554 A CN109431554 A CN 109431554A
Authority
CN
China
Prior art keywords
closer
vascular puncture
sheath
mouth
vascular
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201810959536.4A
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Chinese (zh)
Inventor
孙丽娜
刘迪东
毛玉兰
钟午健
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shenzhen Maipuqi Medical Technology Co Ltd
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Shenzhen Maipuqi Medical Technology Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shenzhen Maipuqi Medical Technology Co Ltd filed Critical Shenzhen Maipuqi Medical Technology Co Ltd
Priority to CN201810959536.4A priority Critical patent/CN109431554A/en
Publication of CN109431554A publication Critical patent/CN109431554A/en
Pending legal-status Critical Current

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Classifications

    • 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
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C39/00Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
    • B29C39/02Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • 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
    • A61B2017/00646Type of implements
    • A61B2017/00654Type of implements entirely comprised between the two sides of the opening
    • 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
    • A61B2017/00778Operations on blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties

Abstract

The invention discloses a kind of interventional medicine I-shaped closers of vascular puncture mouth and preparation method thereof, the closer is dies such as figure (1), by closer 1., in closer epitheca 2. 4., joystick control 3. 5., inner core tube 6. 7., 8. connecting line forms, it is the closer that " I " fonts are fabricated to by biodegradable macromolecule polyalcohol, the interior outward buckle disk folder of high resiliency memory performance closes intravascular outer wall, it is enough degradable in 4-6 weeks, be conducive to the regeneration and reparation of vascular wall.This I-shaped vascular puncture mouth closer is easy to operate, can effectively close vascular puncture mouth, it can effectively reduce postoperative risk, alleviates the pain of patient and the intensity of medical treatment and nursing.

Description

A kind of interventional medicine I-shaped closer of vascular puncture mouth and preparation method thereof
Technical field
The present invention relates to a kind of interventional medicine I-shaped closers of vascular puncture mouth and preparation method thereof, and in particular to It is the closer and preparation method thereof for closing vascular puncture mouth after the minimally invasive intervention of one kind is performed the operation, belongs to medical instruments field,
Background technique
Intravascular Minimally Interventional Therapy technology is widely used in clinic in recent years, is based on the tracer in medical imaging device Under look-out, interventional medical device is sent to human body vitals and position, such as: heart, brain, kidney, digestive system and reproduction System carries out the new technology and method of diagnosing and treating, there is small wound, therapeutic process and hospital stays significantly to shorten, payment for medical care The advantages of with relative moderate.Traditional medical method is substituted using minimal invasive techniques and carries out Clinics and Practices operation, is had become at present Medical domain treats the most widely used medical procedure of full spectrum of threats human health disease, micro- at present in all operations Ratio shared by wound interventional therapy alreadys exceed 85%, and the minimally invasive interventional medicine of intravascular has evolved into modern medicine in recent years One of the three big diagnoses and treatment technologies arranged side by side with department of medicine and surgery, and a clinical speciality with fastest developing speed in recent years, are doctors Treat the hot spot of boundary's development.
Currently, how the puncture orifice on quick-make vascular wall is still one not yet in intravascular intra-operative procedures The problem solved very well, also because needing to carry out either manual pressure first and reinforce wrapping delay operation time, art at present Row is extracted again after being formed to the constraint of patient and puzzlement, postoperative false aneurysm afterwards, need to stop for a long time after anticoagulation Being limited in bed for a long time with press sealed puncture orifice, reservation leads to urinary hesitancy and in the presence of because closing undesirable danger complications. Document report in the world uses the vascular complication incidence of conventional vascular hemostasis by compression for 5-9% after femoral artery puncture.State Interior document report, the occurrence rate of hematoma 20.9%, false aneurysm incidence are 14.55%, bleeding event 7.27%.Such as This high not disease, so that how fast and vascular puncture mouth becomes minimally invasive menses anxious to be resolved after effectively turning off blood vessel intervention The problem of pipe intervention apparatus research and development and production.Clinically, domestic at present mainly by extracting earlier either manual pressure after catheter sheath, then Based on the method for pressure dressing, constraint and limitation patient activity.Thus it is subcutaneously huge to be likely to occur postoperative site of puncture for some patientss The dangerous complication such as big hemotoncus, the big bleeding of puncture orifice.So do not only result in intravascular intervention operation take a long time, patient it is postoperative Very uncomfortable and puzzlement and worry there is postoperative complications.
External and Some Domestic large hospital uses the intervention site of puncture haemostat (commodity of Terumo company, Japan production Name: TR-Band);StarClose the and Proglide blood vessel of U.S. StJude company Angio-Seal and Abott company, the U.S. Puncture orifice closer.These instruments largely shorten the time of After Endovascular Interventional Procedures, alleviate the discomfort of patient. But all jointly there is: operating process is excessively cumbersome, price is excessively high, close effect it is different the deficiencies of.And due to import Closer is at high price, and most domestic hospital have to select using either manual pressure, then pressure dressing limit in most basic art It makes movable mode and handles vascular puncture mouth.
Summary of the invention
The purpose of the present invention is create a kind of pass that can be quickly and effectively closed minimally invasive intervention post-surgical vascular puncture orifice Device is closed, vascular puncture mouth closer solves clinical problem from following several respects:
Outspoken fast closer action principle innovation-" I " fonts closer of interventional medicine vascular puncture, inside and outside vascular wall " I " fonts clips are closed:
" I " fonts have the advantages that the deadend of puncture orifice: first, without similar state in mode of operation Outer similar closer need to check blood back and many and diverse operating procedure, can complete at once, reach simple and easy to do feature.Second, The closing of " work " word structure, can reach the effect of tight closure due to linking closely up and down.
Innovation -- the selection of novel internal degradable material of the outspoken fast closer making material of interventional medicine vascular puncture:
The present invention uses biodegradable material for the first time -- and long-chain, which is fitted into, integrates one made by high molecular material-PLLA-TMC The closer of body, the closer complete that whole natural degradations are conducive to vascular wall and are regenerated in three months after closure vascular wall And the reparation of vascular integrity.Such high molecular material binding soln casting is not only easy to 3 dimension spaces of molding making complexity Configuration keeps manufacturing process fast and convenient, and its physical characteristic for combining elasticity and being rigidly integrated is extremely easy to be fabricated to Conducive to medical instrument used in Minimally Interventional Therapy.
The completely new accurate quick shaping process of the outspoken fast closer of interventional medicine vascular puncture-satellite centrifugal process casting essence Close molding: high molecular material is usually gone in solution dissolution, mixing and scatter operation using stirring and dissolving and negative-pressure ward Bubble technology, such method not only low efficiency, Yi Liucun bubble, and quality is difficult to be guaranteed.The present invention uses satellite differential Centrifugal process has the function of Quick uniform mixing and drives away bubble in solution simultaneously, and dissolution is abundant and defoams and evenly dispersed effect It is prominent, it ensure that the quality of production closer.
After the closer is placed to Endovascular by short sheath, the application method of the closer can be summarized as follows: one is moved back One drawing is further moved back.
One moves back: exiting closer outer tube (3. manipulation epitheca joystick control is completed) makes the closer lower wall of bottom in lumen of vessels It inside flicks discoid.
One draws: pulling, makes in the disc-shaped opening of Endovascular outward together together with short sheath and connecting line and closer Lower wall is adjacent to vascular puncture mouth inner wall.
One moves back: exit closer inner tube (manipulation epitheca joystick control 5. complete), turn off on device disk can appliance for releasing single in blood It is flicked at pipe puncture orifice outer wall, forms the external disk of covering vascular puncture mouth.
Technical indicator
The scope of application: it can be used for the quick-make of caused vascular wall puncture orifice after the short sheath of 5F to 14F punctures.
It closes effect: realizing vessel sealing immediately.
Operation difficulty: (the external complicated similar products of comparison) are reduced to insertion, push, the easy operating process of outer drawing.
Detailed description of the invention
Fig. 1 is the short sheath structural schematic diagram of the present invention;
Fig. 2 is " I " fonts closer structural schematic diagram of the present invention;
Fig. 3 is that schematic diagram after sheath is extracted in present invention push pipe integrated installation portion;
Fig. 4 is that short sheath pulls out schematic diagram after sheath is extracted in present invention push pipe integrated installation portion;
Fig. 5 is the I-shaped short sheath of the present invention and guy structure schematic diagram thereon;
Fig. 6 is inventive die production schematic diagram;
Fig. 7 is closer production process of the present invention and step schematic diagram;
Fig. 8 is " I " fonts closer of the present invention and sphygmomanometer attachment structure schematic diagram.
Specific embodiment
Raw material selection: biodegradable material -- long-chain is fitted into high molecular material-PLLA-TMC, can be short for invention selection It is degraded in time by body absorption, and vascular wall puncture orifice will be slowly replaced by blood vessel hyperplasia tissue, reach vascular wall reparation It rebuilds.
As shown in figures 1-8.
Embodiment:
Production process and step 1, " I " fonts closer modelling, satellite differential centrifugation, moulding by casting.Macromolecule Material usually solution dissolution, mixing and scatter operation in using stirring and dissolving and negative-pressure ward de-soak technology, it is such Method not only low efficiency, Yi Liucun bubble, and quality is difficult to be guaranteed.The present invention is had quick using satellite differential centrifugation The effect of bubble in solution is uniformly mixed and driven away simultaneously, abundant and defoaming and evenly dispersed effect protrusion is dissolved, ensure that system Make the quality of closer.
2, sheath, push pipe production.
3, " I " fonts closer, sheath, push pipe integrated installation, sealed package.
After being punctured short sheath merging vascular puncture mouth, implemented by easy following steps:
1, push pipe button is pushed, closer is pushed into Endovascular;
2, it extracts outward and punctures short sheath, can experience at this time and close upper valve and dashed forward vascular puncture mouth, closer rests on blood By tube wall.
3, continue to extract short sheath, cut and expose in extracutaneous connecting line, shutoff operation is completed.
4, after the completion of closing, closer is located at the inside and outside of vascular wall, realizes quick-make vascular puncture mouth.
External simulation test
1, it is carried out in vitro test closed duct system as shown in figure (8).In the system, the silicone tube of 6mm internal diameter is rushed Full water, silicone tube distal end are closed, and the other end then connects the plastic infusion bottle to be pressurizeed by sphygmomanometer.Sphygmomanometer pressurizes and stablizes 130mm mercury column.Therefore, hydraulic in silicone tube is also all 130mm mercury column.
2, in vascular puncture interventional procedure, intravascular fluid pressure and vascular intervention operation proceed to modeling Short sheath is extracted, the stage of vascular wall puncture orifice is closed.Test result: I-shaped closer can close simple and effectively blood vessel and wear Mouth is pierced, blood outflow is stopped.
Actual effect of the invention: directly blocking and sealing blood vessels wall opening have reached best closing vascular puncture mouth Effect, biodegradable material can deadend of the slow-absorbing completion to vascular wall puncture orifice.The present invention not only greatly mitigates Medical worker be closed the workload consumed when vascular puncture mouth, it is simple and effective be closed vascular puncture mouth, and be greatly improved through The postoperative comfort level of intravascular minimally invasive intervention, make patient can out-of-bed activity quickly, be conducive to the healing and reparation of puncture orifice.

Claims (5)

1. a kind of interventional medicine I-shaped closer of vascular puncture mouth, it is characterised in that the vascular puncture mouth closer told is Bio-degradable material casts and becomes I-shaped structure, and quick closedown device is using " I " fonts clamp-buckle at puncture orifice position Blood vessel and outer wall on, formed be close to puncture orifice and to puncture orifice realize cover type inside and outside precision clamping close, see figure (1);Figure (2) the differently curved direction of closer upper lower burrs 1. is paid attention to load spare closer in;2. being closer epitheca, controllably Closer lower wall processed;3. moving up control handwheel for epitheca, when the disk drives epitheca to move up, the lower wall meeting appliance for releasing single of closer is at disk Shape is shown in (3);4. can control the upper disk of closer for sheath in closer;5. joystick control is moved up for interior sheath, when the disk drives interior sheath When moving up, on closer disk can appliance for releasing single it is discoid, see (4);7. the company of closer can be passed through among the pipe 6. being inner core tube 8., the bottom of the inner core approaches the rear of disk on closer for wiring.
2. a kind of interventional medicine according to claim 1 I-shaped closer of vascular puncture mouth, it is characterised in that told Closer be vertical section overstriking I-shaped structure, in closed configuration, under the " I " fonts in 3 or 4 valve lobulateds Disk not only entered Endovascular convenient for loading and being conducive to push through push sheath, but also wore as endovascular jacking part closure blood vessel Pierce mouth;And the structure above I-shaped becomes the fixation device outside vascular wall, to achieve the purpose that be closed puncture orifice.
3. one kind is with a kind of interventional medicine I-shaped closer of vascular puncture mouth described in claim 1, it is characterised in that: system The raw material for making the I-shaped closer of vascular puncture mouth is to be fitted into high molecular material-PLLA-TMC institute group by biodegradable long-chain At the good biocompatibility of this material can degrade in vivo, and physical strength is high and elastic recovery properties are good.
4. a kind of operating method with vascular puncture mouth closer described in claim 1, it is characterised in that: the present invention is used and defended Star differential centrifugation has the function of Quick uniform mixing and drives away bubble in solution simultaneously, dissolves sufficiently and defoams and uniformly divide The effect of dissipating protrudes, and ensure that the quality of production quick closedown device.
5. a kind of operating method with vascular puncture mouth closer described in claim 1, it is characterised in that: this method include with Lower step: 1) after interventional procedure be nearly completed after, which is placed in Endovascular (this closer pipe range by short sheath More than about 3-5 centimetres of sheath short for model), so that the front end of this closer is projected into Endovascular from short sheath front end;2) it moves up 3., when the disk drives epitheca to move up, the lower wall meeting appliance for releasing single of closer is discoid for epitheca control handwheel, sees (3);3) connect short sheath, Connecting line and closer are pulled outward together, make to be adjacent in vascular puncture mouth in the lower wall of the disc-shaped opening of Endovascular 5. wall then moves up interior sheath joystick control, when sheath moves up in the disk drives, on closer disk can appliance for releasing single in vascular puncture mouth It is flicked at outer wall, forms the external disk of covering vascular puncture mouth, so far, closer forms " work " shape inside and outside vascular puncture mouth Folder closes, and closer is withdrawn from vitro together together with short sheath, end operation.
CN201810959536.4A 2018-08-22 2018-08-22 A kind of interventional medicine I-shaped closer of vascular puncture mouth and preparation method thereof Pending CN109431554A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113940724A (en) * 2021-12-01 2022-01-18 厦门大学附属中山医院 False aneurysm sealer

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070191884A1 (en) * 2005-10-19 2007-08-16 Pulsar Vascular, Inc. Methods and systems for endovascularly clipping and repairing lumen and tissue defects
US20140296907A1 (en) * 2004-08-27 2014-10-02 Accessclosure, Inc. Apparatus and Methods for Facilitating Hemostasis within a Vascular Puncture
CN105496480A (en) * 2016-01-21 2016-04-20 深圳麦普奇医疗科技有限公司 Blood vessel puncture site closer and operation method thereof
CN107789023A (en) * 2016-08-30 2018-03-13 周佳蓉 Blood vessel puncture sealing device
CN107802311A (en) * 2017-11-20 2018-03-16 乐普(北京)医疗器械股份有限公司 A kind of Wholly-degradable vessel sealing structure

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140296907A1 (en) * 2004-08-27 2014-10-02 Accessclosure, Inc. Apparatus and Methods for Facilitating Hemostasis within a Vascular Puncture
US20070191884A1 (en) * 2005-10-19 2007-08-16 Pulsar Vascular, Inc. Methods and systems for endovascularly clipping and repairing lumen and tissue defects
CN105496480A (en) * 2016-01-21 2016-04-20 深圳麦普奇医疗科技有限公司 Blood vessel puncture site closer and operation method thereof
CN107789023A (en) * 2016-08-30 2018-03-13 周佳蓉 Blood vessel puncture sealing device
CN107802311A (en) * 2017-11-20 2018-03-16 乐普(北京)医疗器械股份有限公司 A kind of Wholly-degradable vessel sealing structure

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113940724A (en) * 2021-12-01 2022-01-18 厦门大学附属中山医院 False aneurysm sealer

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Application publication date: 20190308

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