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CN114191007A - Heart foramen ovale plugging device - Google Patents

Heart foramen ovale plugging device
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Publication number
CN114191007A
CN114191007ACN202111627817.8ACN202111627817ACN114191007ACN 114191007 ACN114191007 ACN 114191007ACN 202111627817 ACN202111627817 ACN 202111627817ACN 114191007 ACN114191007 ACN 114191007A
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elastic
flow
foramen ovale
cardiac
tightening
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CN202111627817.8A
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CN114191007B (en
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康立标
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Shenzhen Wuyou Medical Technology Co ltd
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Xiongxin Medical Technology Shenzhen Co ltd
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Abstract

The embodiment of the application provides a cardiac foramen ovale occluder, which comprises a connecting piece, a first flow-resisting part, a second flow-resisting part, an elastic part and a tightening part, wherein two ends of the connecting piece are respectively connected with the first flow-resisting part and the second flow-resisting part; the elastic part comprises a first elastic part and a second elastic part, the first elastic part is paved on the first flow blocking part, and the second elastic part is paved on the second flow blocking part; the tightening part is arranged on the periphery of the connecting piece, two ends of the tightening part are respectively connected with the first elastic piece and the second elastic piece, and the tightening part is used for tightening the first flow blocking part and the second flow blocking part. This application embodiment is through setting up connecting piece and tightening part, can make first choked flow portion and second choked flow portion laminate the heart room interval that corresponds respectively after this occluder implants heart oval hole to the heart oval hole is plugged to reach the remaining reposition of redundant personnel's of thoroughly solving oval hole problem.

Description

Heart foramen ovale plugging device
Technical Field
The embodiments of the application belong to the field of instruments for clinical operations, and more particularly, relate to a heart foramen ovale plugging device.
Background
The foramen ovale is a small hole in the septum of the left and right atria, located in the middle and lower part of the atrial septum, and is a "flap-valve-like" structure formed by the inferior border of the secondary septum and the primary septum, through which oxygenated placental blood can pass during pregnancy to the fetal arterial circulation, an important physiological pathway. After birth, with the rise of left atrial pressure, functional closure of the foramen ovale occurs, anatomical closure is achieved within one year, the foramen ovale is not closed beyond three years old and is called as Patent Foramen Ovale (PFO), and the incidence rate of PFO in adults is 25% -33% through investigation.
PFO directly causes right-to-left shunting of the heart, but PFO has long been considered to have no clinical consequence due to its too small shunt volume. In recent years, more and more researches show that the risk of patients with PFO suffering from cerebral apoplexy, migraine, peripheral arterial embolism, decompression sickness and the like is increased by several times compared with normal people, and the pathogenic effect of PFO causes the attention of extensive experts and scholars.
At present, the clinical application mainly uses a catheter instrument to convey the occluder to the position of the foramen ovale to mechanically occlude the foramen ovale.
The existing occluders basically comprise two elastic disk parts, and when the occluders are used, the two disk parts are respectively attached to the next walls of the left atrium and the right atrium so as to realize occlusion of the foramen ovale. For example, chinese patent ZL202011619405.5 discloses a degradable patent occluder for cardiac patent foramen ovale and a method for manufacturing the same, the occluder is composed of a flow-blocking member, a tubular portion, a connecting member and two disk portions, and the tubular portion and the two disk portions are woven by using an elastic net. When the occluder is used clinically, the occluder is usually conveyed to a foramen ovale area by a conveying pipe, then released, and attached to the atrial septal wall of the left atrium and the right atrium through the elastic tension of the elastic net, so that the aim of sealing the foramen ovale is fulfilled.
The current plugging device lacks tightening part and supporting component, because the difference of each person of the form of oval hole is very big, only relies on the elastic tension of elasticity net self to warp after the plugging device implantation and resets, can't guarantee to laminate heart room interval completely at every turn, leads to can not the complete shutoff oval hole, and this has just caused postoperative oval hole still has remaining reposition of redundant personnel. In addition, the occluder belongs to foreign matters in the heart, and in the long-term implantation process, the tissue cells can gradually cover the foreign matters, which is called endothelialization process. However, this greatly prolongs the endothelialization process since the occluding device does not fully conform to the atrial septum after implantation. The occluder made of degradable materials can be degraded in a certain time after being implanted, and if the endothelialization process is not completed after degradation, the process is equivalent to that the foramen ovale is not occluded, so that the operation fails.
Disclosure of Invention
In order to solve the problems of the existing occluder, the application provides a cardiac foramen ovale occluder which comprises a connecting piece, a first flow-resisting part, a second flow-resisting part, an elastic part and a tightening part, wherein two ends of the connecting piece are respectively connected with the first flow-resisting part and the second flow-resisting part; the elastic part comprises a first elastic part and a second elastic part, the first elastic part is laid on the first flow blocking part, the second elastic part is laid on the second flow blocking part, the tightening part is arranged on the periphery of the connecting part, two ends of the tightening part are respectively connected with the first elastic part and the second elastic part, and the tightening part is used for tightening the first flow blocking part and the second flow blocking part.
As a further improvement of the embodiment of the application, the tightening part comprises a plurality of tightening pieces arranged at intervals, and the plurality of tightening pieces are arranged on the periphery of the connecting piece along the extending direction of the connecting piece.
As a further improvement of the embodiment of the present application, two ends of the plurality of tighteners are further connected to the first flow-blocking portion and the second flow-blocking portion, respectively.
As a further improvement of the embodiment of the present application, two ends of the plurality of tighteners are further connected to the first flow-blocking portion and the second flow-blocking portion outer end, respectively.
As a further improvement of the embodiment of the application, a plurality of tightening pieces are arranged on the periphery of the connecting piece in a pairwise symmetry manner.
As a further improvement of the embodiment of the application, the tightening piece is of a linear structure.
As a further improvement of the embodiment of the present application, the first flow blocking portion and the second flow blocking portion are disc-shaped structures having elasticity.
As a further improvement of the embodiment of the present application, the first flow-obstructing portion and the second flow-obstructing portion have the same diametrical area.
As a further improvement of the embodiment of the present application, the elastic portion further includes a third elastic member, the third elastic member is laid on the connecting member, and two ends of the third elastic member are respectively connected to the first elastic member and the second elastic member.
As a further improvement of the embodiment of the present application, the first elastic member, the second elastic member and the third elastic member are all elastic net bodies.
As a further improvement of the embodiment of the present application, the first elastic member, the second elastic member, and the third elastic member are integrally formed.
As a further improvement of the embodiment of the application, the connecting piece is of a columnar structure.
As a further improvement of the embodiment of the present application, the connecting member is connected to the axial centers of the first flow blocking portion and the second flow blocking portion.
As a further improvement of the embodiment of the present application, a connection hole is provided on the first flow blocking portion or the second flow blocking portion, and the connection hole extends into the connection member.
As a further improvement of the embodiment of the application, the inner wall of the connecting hole is provided with an internal thread.
As a further improvement of the embodiments of the present application, surfaces of the connecting member, the elastic portion, the first flow blocking portion, the second flow blocking portion, and the tightening portion are provided with an anti-blood clotting coating and/or a developing coating, respectively.
Compared with the prior art, this application embodiment under heart room partition's effect, tighten up through the tightening part first choked flow portion with second choked flow portion to can make first choked flow portion and second choked flow portion laminate the heart room interval that corresponds respectively after heart oval hole is implanted to this occluder, thereby the heart oval hole is plugged up in the shutoff, plays simultaneously through the connecting piece and connects and support first choked flow portion with the effect of second choked flow portion, thereby make first choked flow portion with second choked flow portion is difficult to the aversion deformation, thereby thoroughly solves the remaining problem of shunting of oval hole.
Drawings
The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the application and together with the description serve to explain the application and not to limit the application. Some specific embodiments of the present application will be described in detail hereinafter by way of illustration and not limitation with reference to the accompanying drawings. The same reference numbers will be used throughout the drawings to refer to the same or like parts or portions, and it will be understood by those skilled in the art that the drawings are not necessarily drawn to scale, in which:
FIG. 1 is a schematic diagram of the overall structure of an embodiment of the present application;
FIG. 2 is a schematic front view of a projection structure according to an embodiment of the present application;
FIG. 3 is a schematic view of the cross-sectional structure A-A of FIG. 2;
figure 4 is a structural schematic diagram of an implanted state of the occluder in the embodiment of the present application.
Reference numerals: 1. a connecting member; 2. a first flow-impeding portion; 3. a second flow-impeding portion; 4. a first elastic member; 5. a second elastic member; 6. a tightener; 7. a third elastic member; 8. connecting holes; 9. an internal thread.
Detailed Description
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs; the terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application; the terms "including" and "having," and any variations thereof, in the description and claims of this application and the description of the above figures are intended to cover non-exclusive inclusions. The terms "first," "second," and the like in the description and claims of this application or in the above-described drawings are used for distinguishing between different objects and not for describing a particular order.
In order to make the technical solutions better understood by those skilled in the art, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. It is to be understood that the described embodiments are merely exemplary of some, and not all, of the present application. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
As shown in fig. 1-3, an embodiment of the present application provides a cardiac foramen ovale occluder, which includes a connectingmember 1, a first flow-blockingportion 2, a second flow-blockingportion 3, an elastic portion, and a tightening portion, where two ends of the connectingmember 1 are connected to the first flow-blockingportion 2 and the second flow-blocking portion 3, respectively, in order to ensure balance between the two first flow-blockingportions 2 and the second flow-blockingportion 3, the connectingmember 1 is connected to axes of the first flow-blockingportion 2 and the second flow-blockingportion 3, the connectingmember 1 is used to support the first flow-blockingportion 2 and the second flow-blockingportion 3, and after the occluder is implanted in a heart, the connectingmember 1 passes through a cardiac foramen ovale, and the first flow-blockingportion 2 and the second flow-blockingportion 3 are located in left and right atria atrium, respectively; the firstflow blocking part 2 and the secondflow blocking part 3 are used for blocking the foramen ovale and preventing overflow between the left atrium and the right atrium.
Elastic component includes firstelastic component 4 and secondelastic component 5, and firstelastic component 4 lays on first chokedflow portion 2, firstelastic component 4 and first chokedflow portion 2 fixed connection, and firstelastic component 4 is used for the setting to first chokedflow portion 4, and when implanting this plugging device, firstelastic component 4 can make first chokedflow portion 2 rapid deformation recover and block up the oval hole. The secondelastic part 5 is laid on thesecond choke 3 part, and the secondelastic part 5 is connected with thesecond choke 3 part; secondelastic component 5 is used for the setting to second chokedflow portion 3, when implanting this occluder, secondelastic component 5 can make second chokedflow portion 3 rapid deformation recover and block up the oval hole, in this application embodiment, firstelastic component 4 and first chokedflow portion 2 pass through bonding mode fixed connection, secondelastic component 5 also passes through bonding mode fixed connection with second chokedflow portion 3, this application does not do the restriction to the connected mode between elastic component and the choked flow portion, as long as can reach the mode of fixing between elastic component and the choked flow portion and all belong to the protection scope of this application.
In the embodiment of the present application, the firstelastic element 4 and the secondelastic element 5 are respectively laid on the surfaces of the firstflow blocking portion 2 and the secondflow blocking portion 3 close to the connectingpiece 1; in other embodiments, the firstelastic element 4 and the secondelastic element 5 may be arranged in any one of the following ways: the firstelastic part 4 and the secondelastic part 5 are respectively laid on the surfaces of the firstflow blocking part 2 and the secondflow blocking part 3 far away from the connectingpiece 1, or the firstelastic part 4 is laid on the surface of the firstflow blocking part 2 close to the connectingpiece 1, and the secondelastic part 5 is laid on the surface of the firstflow blocking part 2 far away from the connectingpiece 1; or the secondelastic part 5 is laid on the surface of thesecond choke portion 3 close to the connectingpiece 1, the firstelastic part 4 is laid on the surface of thefirst choke portion 2 far from the connectingpiece 1, or both the firstelastic part 4 and the secondelastic part 5 are laid on the whole surfaces of thefirst choke portion 2 and thesecond choke portion 3.
The tightening part is arranged on the periphery of the connectingpiece 1, two ends of the tightening part are respectively connected with the firstelastic piece 4 and the secondelastic piece 5, and the tightening part is used for tightening the firstflow blocking part 2 and the secondflow blocking part 3; after the occluder is implanted into a heart foramen ovale, the tightening part can tighten the firstflow resisting part 2 and the secondflow resisting part 3 by pulling the firstelastic part 4 and the secondelastic part 5, so that the firstflow resisting part 2 and the secondflow resisting part 3 are tightly attached to the partition wall of the corresponding atrium respectively, and the aim of occluding the foramen ovale is fulfilled.
The surfaces of the connectingpiece 1, the elastic part, the firstflow blocking part 2, the secondflow blocking part 3 and the tightening part are respectively provided with an anti-blood coagulation coating. In the examples of the present application, heparin is the main component of the anti-blood clotting coating. The blood coagulation resisting coating is arranged, so that the blood coagulation in the heart can be prevented after the occluder is implanted into the heart, and the generation of thrombus can be prevented to a certain extent.
Connecting piece 1, elasticity portion, first chokedflow portion 2, second chokedflow portion 3 and the surface of tightening part still are equipped with the development coating respectively, make this plugging device can be observed under the shining of X-ray through setting up the development coating, help medical personnel to know the deformation condition of reseing after this plugging device implants the heart to judge whether this plugging device is successful to the shutoff of oval hole.
The tightening part comprises 8tightening pieces 6 in a strip structure, and in other embodiments, the number of the tighteningpieces 6 can be other; thetightening piece 6 is made of flexible material and can be made into shapes of wires, lines and the like; the 8tightening pieces 6 are arranged on the periphery of the connectingpiece 1 at equal intervals along the extending direction of the connectingpiece 1; the two ends of thefastening member 1 are fixedly connected with the firstelastic member 4 and the secondelastic member 5 respectively.
In order to increase the tightening tension of thetightener 6, in the present embodiment, thetightener 6 is provided at the outer end positions of the first and second flow-obstructingportions 2 and 3, respectively, so as to better tighten the first and second flow-obstructingportions 2 and 6.
In order to ensure that the tightening tension of the 8tighteners 6 is uniform for each region of the first flow-blockingportion 2 and the second flow-blockingportion 6, in the embodiment of the present application, the 8 tighteners are arranged two by two symmetrically at the periphery of the connectingmember 1.
When this plugging device of preparation, tighteningpart 6 can be that single line twines firstelastic component 4 and secondelastic component 5 and forms, also can be to make with many lines interlude, and the tightening part can be that single line alternates two first chokedflow portion 2 and second chokedflow portion 6 and form, and the tightening part also can be that a plurality of tighteningparts 6 alternate two first chokedflow portion 2 and second chokedflow portion 6 and form.
Connecting piece 1 makes cylindric structure for rigid material, andrigid connection piece 1 can ensure this plugging device and implant back, and first chokedflow portion 2 and second chokedflow portion 3 can play the supporting role when being stretched and warp bytightener 6, and in this application embodiment, connectingpiece 1 is solid construction.
The elastic part further comprises a thirdelastic member 7, the thirdelastic member 7 is laid on the outer surface of the connectingmember 1, and the thirdelastic member 7 is connected with the firstelastic member 4 and the secondelastic member 5 respectively. The firstelastic part 4, the secondelastic part 5 and the thirdelastic part 7 are all net bodies with elasticity, and the firstelastic part 4, the secondelastic part 5 and the thirdelastic part 7 are integrally formed. The firstelastic part 4, the secondelastic part 5 and the thirdelastic part 7 can be formed by laser cutting or can be manufactured by weaving or the like, the thirdelastic part 7 can be arranged to play a role in fixing the connectingpart 1, the connectingpart 1 can be bonded or fixed with the thirdelastic part 7 in a mechanical binding mode, and the embodiment of the application is not limited to the method.
The firstflow blocking portion 2 and the secondflow blocking portion 3 are both elastic disc-shaped structures, and the diameter areas of the firstflow blocking portion 2 and the secondflow blocking portion 3 are the same. When the plugging device is assembled, the thirdelastic part 7 is laid on the surface of the connectingpart 1, and the firstelastic part 4 and the secondelastic part 5 are laid on the corresponding surfaces of the firstflow blocking part 2 and the secondflow blocking part 3; draw firstelastic component 4 and secondelastic component 5 through the portion of tightening up to make first choked flow portion and 2 second chokedflow portion 3 contract to the direction that is close to each other, make first chokedflow portion 2 and second chokedflow portion 3 closely laminate with the next door that corresponds the atrium respectively, in order to reach the purpose of shutoff foramen ovale. In order to facilitate the connection and fixation of the plugging device and an external conveying system, a connectinghole 8 is formed in the center of the firstflow blocking part 2, the connectinghole 8 extends into the connectingpart 1, and aninternal thread 9 is formed in the connectinghole 8. When the plugging device is implanted, the connectinghole 8 is in threaded connection with a conveying pipe of a conveying system, so that the plugging device is fixed on the conveying pipe and is conveyed into a heart oval hole through the conveying pipe; then the connection between the connectinghole 8 and the delivery pipe is loosened, and the plugging device is left in the heart foramen ovale to finish the process of plugging the foramen ovale.
In other embodiments, theconnection opening 8 can also be provided on the second flow-impedingpart 3 and the function and use is the same as on the first flow-impedingpart 2.
In the embodiment of the application, all the components in the occluder can be made of one or more of the following degradable materials: polylactic acid, poly-L-lactic acid, poly-D-lactic acid, polyglycolic acid, polycaprolactone, polydioxanone, polyhydroxybutyrate, polyanhydride, polyphosphate, polyurethane, polycarbonate and silk fibroin. After the plugging device is implanted into a human body, the plugging device can be absorbed by the human body after the endothelial cell process is finished in the human body along with the lapse of time, so that the long-term influence of foreign matter implantation on the human body is avoided.
Of course, in other embodiments, the components in the occluding device can be made of non-degradable materials such as medical plastics or metals partially or completely.
When the occluder is used, the connectinghole 8 of the occluder is firstly connected and fixed with the conveying pipe of the conveying system, then the occluder is put into the conveying pipe, the occluder is conveyed to the position of the heart foramen ovale through the conveying pipe, then the conveying pipe is loosened from the connectinghole 8, and the conveying pipe is pulled out, so that the occluder stays on the foramen ovale.
As shown in fig. 4, after the delivery pipe is drawn out, the stopper is rapidly deformed and restored under the elastic tension of the elastic part and the flow resisting part; at the moment, the connectingpiece 1 just penetrates through the foramen ovale, and the first flow blocking part and the secondflow blocking part 2 and 3 are respectively positioned in the left atrium and the right atrium; in the process of restoring and deforming the plugging device, the tighteningpieces 6 are respectively abutted against the side edges of the oval holes; along with the continuation of plugging device recovery deformation, the lateral wall of oval hole can oppress tighteningpart 6, and tighteningpart 6 receives radial pressure to take place deformation, and tighteningpart 6 is pulling first chokedflow portion 2 and second chokedflow portion 3 through the elasticity portion and is taking place to the crooked deformation of oval hole direction to make two choked flow portions laminate the atrial septum wall that corresponds the atrium respectively, accomplished the shutoff to heart oval hole.
Finally, it should be noted that: the above embodiments are only used for illustrating the technical solutions of the present application, and not for limiting the same; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present application.

Claims (16)

CN202111627817.8A2021-12-282021-12-28 A cardiac foramen ovale occluderActiveCN114191007B (en)

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CN202111627817.8ACN114191007B (en)2021-12-282021-12-28 A cardiac foramen ovale occluder

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Application NumberPriority DateFiling DateTitle
CN202111627817.8ACN114191007B (en)2021-12-282021-12-28 A cardiac foramen ovale occluder

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CN114191007Atrue CN114191007A (en)2022-03-18
CN114191007B CN114191007B (en)2024-11-22

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication numberPriority datePublication dateAssigneeTitle
CN117503243A (en)*2023-11-302024-02-06北京昕科医疗科技有限公司Aneurysm plugging device
CN118614971A (en)*2024-08-142024-09-10广州医科大学附属第一医院(广州呼吸中心) Esophageal fistula occluder

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* Cited by examiner, † Cited by third party
Publication numberPriority datePublication dateAssigneeTitle
US5171259A (en)*1990-04-021992-12-15Kanji InoueDevice for nonoperatively occluding a defect
WO2001010306A1 (en)*1999-08-092001-02-15Salviac LimitedAn occluder with anchor
CN103249374A (en)*2010-07-022013-08-14Pfm医疗股份公司 Left atrial appendage closure device
CN107080564A (en)*2017-05-222017-08-22王有然Single riveting, self-adaptation type oval hole plugging device
CN109199469A (en)*2018-08-302019-01-15武汉唯柯医疗科技有限公司One kind previously preventing from generating thrombus oval hole plugging device and preparation method thereof
CN208926491U (en)*2018-07-192019-06-04贵州省人民医院 An occluder for the treatment of congenital heart disease

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication numberPriority datePublication dateAssigneeTitle
US5171259A (en)*1990-04-021992-12-15Kanji InoueDevice for nonoperatively occluding a defect
WO2001010306A1 (en)*1999-08-092001-02-15Salviac LimitedAn occluder with anchor
CN103249374A (en)*2010-07-022013-08-14Pfm医疗股份公司 Left atrial appendage closure device
CN107080564A (en)*2017-05-222017-08-22王有然Single riveting, self-adaptation type oval hole plugging device
CN208926491U (en)*2018-07-192019-06-04贵州省人民医院 An occluder for the treatment of congenital heart disease
CN109199469A (en)*2018-08-302019-01-15武汉唯柯医疗科技有限公司One kind previously preventing from generating thrombus oval hole plugging device and preparation method thereof

Cited By (4)

* Cited by examiner, † Cited by third party
Publication numberPriority datePublication dateAssigneeTitle
CN117503243A (en)*2023-11-302024-02-06北京昕科医疗科技有限公司Aneurysm plugging device
CN117503243B (en)*2023-11-302024-05-17北京昕科医疗科技有限公司Aneurysm plugging device
CN118614971A (en)*2024-08-142024-09-10广州医科大学附属第一医院(广州呼吸中心) Esophageal fistula occluder
CN118614971B (en)*2024-08-142024-12-03广州医科大学附属第一医院(广州呼吸中心) Esophageal fistula occluder

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Address after:518122 Guangdong Province, Shenzhen City, Pingshan District, Kengzi Street, Jinsha Community, Jinhui Road No. 14, Biopharmaceutical Innovation Industrial Park, Building 13, Room 301, Building 10, Room 503, Building 10, Room 504

Patentee after:Shenzhen Wuyou Medical Technology Co.,Ltd.

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Address before:518000 503, building 10, Shenzhen Biomedical Innovation Industrial Park, No. 14, Jinhui Road, Jinsha community, Kengzi street, Pingshan District, Shenzhen, Guangdong

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