CN101966092A - Medical plugging device - Google Patents

Medical plugging device Download PDF

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Publication number
CN101966092A
CN101966092A CN 201010287504 CN201010287504A CN101966092A CN 101966092 A CN101966092 A CN 101966092A CN 201010287504 CN201010287504 CN 201010287504 CN 201010287504 A CN201010287504 A CN 201010287504A CN 101966092 A CN101966092 A CN 101966092A
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CN
China
Prior art keywords
plugging device
cock body
plug
turn
medical plugging
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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.)
Granted
Application number
CN 201010287504
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Chinese (zh)
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CN101966092B (en
Inventor
K·库玛
王永胜
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Lifetech Scientific Shenzhen Co Ltd
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Lifetech Scientific Shenzhen Co Ltd
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Priority to CN 201010287504 priority Critical patent/CN101966092B/en
Publication of CN101966092A publication Critical patent/CN101966092A/en
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Publication of CN101966092B publication Critical patent/CN101966092B/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical 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
    • A61B17/12Surgical 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
    • A61B17/0057Implements 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
    • 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
    • A61B2017/00592Elastic or resilient implements
    • 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
    • A61B2017/00641Implements 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 closing fistulae, e.g. anorectal fistulae

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

Abstract

The invention relates to a medical plugging device. The device comprises a plug, wherein the plug is woven by elastic wires; the medicinal plugging device also comprises a spring ring which is connected with the plug and used for fixing the plug; one end of the spring ring is fixed with one end of the plug; the spring ring is formed into a curly shape by winding the metal wire; and the spring ring is deformed when being tensioned by external force and restored when the external force is removed. The device can be conveyed to a specified position by a conveying sheath catheter with small diameter by percutaneous puncture so as to plug a lesion part; the plug is supported against the lesion part by elasticity; the spring ring is pulled towards one side away from the plug and presses against the heart or wall of the blood vessel by the elasticity of the spring ring; the plug is prevented from moving away from the spring ring; and the plug is fixed at a required position by the elasticity and the interaction of the plug and the spring ring.

Description

Medical plugging device
Technical field
The present invention relates to a kind of medical apparatus and instruments, relate in particular to a kind of medical plugging device that is used for the congenital heart disease interventional therapy.
Background technology
Congenital heart disease is meant fetal period heart or trunk abnormal development and the lopsided type disease that causes, be neonate and Childhood (the particularly child below 4 years old) modal heart disease, its sickness rate is 8 ‰-12 ‰, and suffering from various congenital heart diseases in the neonate of the annual birth of China has 150,000-200,000 people approximately.
The traditional Therapeutic Method of congenital heart disease is a surgical operation, but surgical operation is bigger to the wound of patient's body, certain postoperative complication is arranged and leave cicatrix, and the body and mind that influences the patient is grown up.Porstmann used sponge plug shutoff ductus arteriosus in 1967.King in 1974 and Rashkind in 1977 have successfully realized the atrial septal defect shutoff art of interventional therapy.1992, Cambier reported that at first applied spring embolus shutoff patent ductus arteriosus achieves success.Amplatzer had invented the heart occluder that super-elastic shape memory alloy material Ni tinol (Nitinol) makes in 1997, and was successfully applied to clinical.The result shows that it has the advantage that safety is good, easy and simple to handle, controllability is strong, complication is few, has therefore obtained promoting widely, and has made interventional therapy become a kind of main congenital heart disease therapeutic modality.
The major product that is applied to the congenital heart disease interventional therapy at present has atrial septal defect (ASD) stopper, patent ductus arteriosus (PDA) stopper, ventricular septal defect (VSD) stopper, patent foramen ovale (PFO) stopper, vascular plug, turn.Wherein atrial septal defect plugging device, patend ductus arteriosus occluder, ventricular septal defect are to use maximum products, representative products is the Amplatzer stopper, its structure is the Nitinol net umbrella-shaped structure of double plate, connects by waist between two dishes, is sewed with the choked flow film in the centre of umbrella disk.Patent foramen ovale (PFO) stopper is used very extensive in American-European countries, Amplatzer PFO stopper structure also is the Nitinol net umbrella-shaped structure of a double plate, connects by eel-like figure between two dishes, is sewed with the choked flow film in the centre of umbrella disk; The right dish of Spider PFO stopper is Nitinol net umbrella disk structure, and a left side is coiled by four connecting rods and sewed up superincumbent PTFE film and form, and left side dish is connected for universal joint with right side dish.Be mainly used to shutoff ductus arteriosus and inaccessible abnormal vascular in the vascular plug heart treatment formerly, generally has columniform Nitinol network structure, the product that has is sewed with the choked flow film inside, and the product that has does not have the choked flow film, intercepts blood flow by very fine and close Nitinol network structure.Be mainly used to shutoff lung artery and vein fistula and ductus arteriosus, particularly undersized ductus arteriosus in the turn heart treatment formerly.
Atrial septal defect of the prior art (ASD) stopper, patent ductus arteriosus (PDA) stopper, ventricular septal defect (VSD) stopper, patent foramen ovale (PFO) stopper, applied delivery conduit external diameter is usually greater than 5French (1mm=3French), therefore require patient's age greater than 3 years old, for of the restriction of littler infant, and can not use because of blood vessel diameter; These stoppers have strict requirement for damaged anatomic form, not all damagedly all can use.Can pack into the delivery conduit of minor diameter of vascular plug and turn, be used for the treatment of patent ductus arteriosus, but they are fit to put into piped ductus arteriosus usually, for the ductus arteriosus of funnel-form, window shape, dumbbell shaped, aneurysmal, can not use because be difficult to fixing.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of medical plugging device of mixed type, can not carry and can not put into the complicated problems such as lesion locations of part dissection by the less delivery sheath of diameter to solve medical plugging device of the prior art.
Solving the technical scheme that technical problem of the present invention adopts is: a kind of medical plugging device is provided, it comprises a cock body, described cock body is to form with the elastic yarn braiding, described medical plugging device also comprises the turn that is connected and is used for fixing described cock body with described cock body, one end of described turn and an end of described cock body are fixed together, described turn twines with tinsel and is shaped as curling shape, and described turn is out of shape when force-extension, restores to the original state again when removing external force.
As the further improvement of the medical plugging device of the present invention, described turn is around described cock body.
As the further improvement of the medical plugging device of the present invention, described turn is arranged on described cock body one side.
As the further improvement of the medical plugging device of the present invention, described turn is around one to three week.
As the further improvement of the medical plugging device of the present invention, an end of described turn and an end of described cock body are together telescopic joint by one.
As the further improvement of the medical plugging device of the present invention, an end of described cock body is provided with a bolt head, and described bolt head is connected with an induction system.
As the further improvement of the medical plugging device of the present invention, being shaped as of described cock body is cylindrical, spherical, taper, bell or umbrella shape.
As the further improvement of the medical plugging device of the present invention, described cock body has an inner chamber, is provided with a slice choked flow film at least in the described inner chamber.
As the further improvement of the medical plugging device of the present invention, described choked flow film is to be made by expanded PTFE, politef or polyester.
As the further improvement of the medical plugging device of the present invention, described elastic yarn and tinsel are nitinol alloy wire or one of described elastic yarn and tinsel are nitinol alloy wire.
Compared with prior art, mixed type heart plugging device provided by the invention can be transported to appointed positions by the less delivery sheath percutaneous puncture of diameter.Firmly the plugging device compression is taken in the delivery sheath earlier, after discharging from delivery sheath, cock body and turn can both be returned to original shape automatically rapidly.During the shutoff diseased region, at diseased region, the choked flow film that inner chamber is provided with strengthens the effect of shutoff blood flow to cock body by resiliency supported.Turn is pulled to the side away from cock body, and turn is pushed down heart or blood vessel wall portion by the elasticity of self, and stops cock body to move to the direction away from turn.Utilize the elasticity and the interaction of cock body and turn, cock body is fixed on needed position.The present invention has the following advantages: (1), cardiac plugging device of the present invention can be carried by the less delivery sheath of diameter, therefore can use in the thinner infant patient of blood vessel; (2), heart plugging device of the present invention is because therefore its good stationarity can expand the scope of congenital heart disease interventional therapy in the lesion locations application of anatomical structure relative complex.
Description of drawings
The invention will be further described below in conjunction with drawings and Examples, in the accompanying drawing:
Fig. 1 is the structural representation of the medical plugging device of the present invention;
Fig. 2 is the structural representation of cock body in the medical plugging device of the present invention;
Fig. 3 is the be hit by a bullet sketch map of spring coil of the medical plugging device of the present invention;
Fig. 4 is the cock body and the turn connection diagram of the medical plugging device of the present invention;
Fig. 5 is the cock body and the another kind of connection diagram of turn of the medical plugging device of the present invention;
Fig. 6 is the connection diagram of the bolt head of the medical plugging device of the present invention;
Fig. 7 is another structural representation of the medical plugging device of the present invention;
Fig. 8 is the sketch map of the umbrella disk shape cock body in another structure of the medical plugging device of the present invention;
Fig. 9 is the turn sketch map in another structure of the medical plugging device of the present invention.
The specific embodiment
In order to make purpose of the present invention, technical scheme and advantage clearer,, the present invention is further elaborated below in conjunction with drawings and Examples.Should be appreciated that specific embodiment described herein only in order to explanation the present invention, and be not used in qualification the present invention.
The invention provides a kind of medical plugging device of implant into body heart, as shown in Figure 1, this medical plugging device is combined by two parts, and it comprises cock body 10 and is connected with this cock body 10 and around the turn 20 of this cock body 10.
As shown in Figure 2, this cock body 10 comprises end socket 1, choked flow film 2, Nitinol net 3 and bolt head 4.End socket 1 and bolt head 4 usefulness rustless steels or Nitinol are made, and they are the fixing two ends of Nitinol net 3 respectively.Bolt head 4 also can be connected with an induction system, for example on bolt head 4 female thread is set, and is connected with the external screw thread coupling of induction system.This choked flow film 2 is made by expanded PTFE (ePTFE), also can be made by polytetrafluoroethylene (PTFE), polyester (PET) or its derived material.This choked flow film 2 is arranged in the inner chamber that the Nitinol net 3 of this cock body 10 forms.This Nitinol net 3 can form with single or the braiding of many marmems (as nitinol alloy wire) material, and it has super-elasticity and default shape, as cylindrical, spherical, taper, bell or umbrella shape.The Nitinol net 3 that is appreciated that this cock body 10 also can form with other elastic yarn braidings.
As shown in Figure 3, this turn 20 can select for use nitinol alloy wire, medical stainless steel silk or medical cochrome silk to make.The concrete manufacturing process of this turn 20 is as follows: earlier that the nitinol alloy wire coiled is elongated spring, coil curl again, and therefrom the mind-set periphery is extended, as required, spiral can around a week to three weeks, can the coiled matrix bowl-shape, heat-treat then, make it to have super-elasticity.
In the present embodiment, the manufacturing process of this medical plugging device is as follows: at first, weave this Nitinol net 3, its braiding process is as follows: earlier 72 nitinol alloy wires are woven into tubular net, in the mould of the special shape of then tubular net being packed into, carry out high-temperature process again, it is shaped as required form.Secondly, in the position shown in the end socket 1 72 nitinol alloy wires are condensed together, Nitinol tow end is passed the stainless sleeve pipe (not shown) of tiny tubulose, the mode that adopts the argon arc welding with nitinol alloy wire be enclosed within the outer field rustless steel sleeve pipe of nitinol alloy wire and merge; Then, use the laser spot welding mode, the end socket 1 that the metal material of smooth in appearance is made is weldingly fixed on the rustless steel sleeve pipe, and nitinol alloy wire end and rustless steel sleeve pipe are all wrapped in the inside, prevents to stab tissue.Once more, the other end and turn 20 in the position shown in the bolt head 4 with 72 nitinol alloy wires condense together, use preceding method, end in the position shown in the bolt head 4 with 72 nitinol alloy wires passes another rustless steel sleeve pipe 6, as shown in Figure 4, center-side with turn 20 penetrates this another rustless steel sleeve pipe 6 again, condenses together with Nitinol tow end.Then, nitinol alloy wire, turn 20 and another rustless steel sleeve pipe 6 are welded together, form a stiff end 5, as shown in Figure 5 by argon arc welding.Once more, as shown in Figure 6,, a bolt head 4 and stiff end 5 are linked together by the mode of laser spot welding.Bolt head 4 all wraps in the inside to nitinol alloy wire end and another rustless steel sleeve pipe 6, and bolt head 4 also is used for connecting the conveying wirerope.At last, can sew up the many or multilamellar choked flow film 2 of one deck at the inner chamber of cock body 10.In this enforcement, sew up three layers of choked flow film 2 in position shown in Figure 2, these three layers of choked flow films 2 are fixed together by the nitinol alloy wire on stitching thread and cock body 10 surfaces.
As shown in Figure 7, Fig. 7 is another structural representation of the medical plugging device of the present invention, the difference of itself and structure described above is: medical plugging device by umbrella disk shape cock body 30 shown in Figure 8 and turn 40 shown in Figure 9 by long rustless steel sleeve pipe 55 be combined intos, turn 40 is fixed on end socket 60 1 sides of umbrella disk shape cock body 30, the i.e. offside of the bolt head 90 of cock body.Umbrella disk shape cock body 30 shown in Figure 8 is formed by nitinol alloy wire braiding setting, and it comprises end socket 60, Nitinol net 70, choked flow film 80, bolt head 90.This choked flow film 80 is to link together by stitching thread and Nitinol net 70.As shown in Figure 9, within the stainless steel sleeve 50 of end insertion with turn 40, this stainless steel sleeve 50 and turn 40 ends are weldingly fixed on together by the argon arc welding.At last, by a long rustless steel sleeve pipe 55 end socket 60 of cock body 30 and the stainless steel sleeve 50 of turn 40 are linked together, and by laser spot welding will long rustless steel sleeve pipe 55 with the end socket 60 of cock body 30 and the stainless steel sleeve 50 of turn 40 are weldingly fixed on.
Mixed type heart plugging device provided by the invention can be transported to appointed positions by the less delivery sheath percutaneous puncture of diameter.Firmly medical plugging device compression is taken in the delivery sheath earlier, after discharging from delivery sheath, cock body and turn can both be returned to original shape automatically rapidly.During the shutoff diseased region, at diseased region, the choked flow film that inner chamber is provided with strengthens the effect of shutoff blood flow to cock body by resiliency supported.Turn is pulled to the side away from cock body, and turn is pushed down heart or blood vessel wall portion by the elasticity of self, and stops cock body to move to the direction away from turn.Utilize the elasticity and the interaction of cock body and turn, cock body is fixed on needed position.
The present invention compared with prior art has the following advantages: (1), heart plugging device of the present invention can be carried by the less delivery sheath of diameter, therefore can use in the thinner infant patient of blood vessel; (2), heart plugging device of the present invention has good stationarity because of it, thereby can expand the scope of congenital heart disease interventional therapy in the lesion locations application of anatomical structure relative complex.
The above only is preferred embodiment of the present invention, not in order to restriction the present invention, all any modifications of being done within the spirit and principles in the present invention, is equal to and replaces and improvement etc., all should be included within protection scope of the present invention.

Claims (10)

1. medical plugging device, it comprises a cock body, described cock body is to form with the elastic yarn braiding, it is characterized in that: described medical plugging device also comprises the turn that is connected and is used for fixing described cock body with described cock body, one end of described turn and an end of described cock body are fixed together, described turn twines with tinsel and is shaped as curling shape, and described turn is out of shape when force-extension, restores to the original state again when removing external force.
2. medical plugging device as claimed in claim 1 is characterized in that: described turn is around described cock body.
3. medical plugging device as claimed in claim 1 is characterized in that: described turn is arranged on described cock body one side.
4. medical plugging device as claimed in claim 1 is characterized in that: described turn is around one to three week.
5. medical plugging device as claimed in claim 1 is characterized in that: an end of described turn and an end of described cock body are together telescopic joint by one.
6. medical plugging device as claimed in claim 1 is characterized in that: an end of described cock body is provided with a bolt head, and described bolt head is connected with an induction system.
7. medical plugging device as claimed in claim 1 is characterized in that: being shaped as of described cock body is cylindrical, spherical, taper, bell or umbrella shape.
8. medical plugging device as claimed in claim 1 is characterized in that: described cock body has an inner chamber, is provided with a slice choked flow film at least in the described inner chamber.
9. medical plugging device as claimed in claim 8 is characterized in that: described choked flow film is to be made by expanded PTFE, politef or polyester.
10. medical plugging device as claimed in claim 1 is characterized in that: described elastic yarn and tinsel are nitinol alloy wire or one of described elastic yarn and tinsel are nitinol alloy wire.
CN 201010287504 2010-09-16 2010-09-16 Medical plugging device Active CN101966092B (en)

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Application Number Priority Date Filing Date Title
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CN101966092B CN101966092B (en) 2012-10-10

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103845096A (en) * 2014-03-10 2014-06-11 上海形状记忆合金材料有限公司 Left auricle plugging device and production method thereof
CN104546054A (en) * 2015-01-19 2015-04-29 上海形状记忆合金材料有限公司 Adjustable plugging device and release method
CN116236237A (en) * 2022-12-21 2023-06-09 南京思脉德医疗科技有限公司 Foramen ovale plugging device and plugging method
CN116236236A (en) * 2022-12-21 2023-06-09 南京思脉德医疗科技有限公司 Oval hole blood sealing plug and plugging device

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1785125A (en) * 2004-12-06 2006-06-14 谢文愉 Method and apparatus for performing lung volume-reducing operation
CN1810219A (en) * 2005-01-28 2006-08-02 深圳市先健科技股份有限公司 Heart septal defect stopper with self regulating function
CN101234041A (en) * 2008-01-31 2008-08-06 上海交通大学 Atrial septal defect plugging device knitted by degradable material

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1785125A (en) * 2004-12-06 2006-06-14 谢文愉 Method and apparatus for performing lung volume-reducing operation
CN1810219A (en) * 2005-01-28 2006-08-02 深圳市先健科技股份有限公司 Heart septal defect stopper with self regulating function
CN101234041A (en) * 2008-01-31 2008-08-06 上海交通大学 Atrial septal defect plugging device knitted by degradable material

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103845096A (en) * 2014-03-10 2014-06-11 上海形状记忆合金材料有限公司 Left auricle plugging device and production method thereof
CN103845096B (en) * 2014-03-10 2016-05-04 上海形状记忆合金材料有限公司 Left atrial appendage occlusion device and preparation method thereof
CN104546054A (en) * 2015-01-19 2015-04-29 上海形状记忆合金材料有限公司 Adjustable plugging device and release method
CN116236237A (en) * 2022-12-21 2023-06-09 南京思脉德医疗科技有限公司 Foramen ovale plugging device and plugging method
CN116236236A (en) * 2022-12-21 2023-06-09 南京思脉德医疗科技有限公司 Oval hole blood sealing plug and plugging device
CN116236236B (en) * 2022-12-21 2023-11-24 南京思脉德医疗科技有限公司 Oval hole blood sealing plug and plugging device
CN116236237B (en) * 2022-12-21 2024-01-26 南京思脉德医疗科技有限公司 Foramen ovale plugging device and plugging method

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