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CN113545891A - A Novel Transcatheter Valve Delivery System - Google Patents

A Novel Transcatheter Valve Delivery System Download PDF

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Publication number
CN113545891A
CN113545891A CN202110839423.2A CN202110839423A CN113545891A CN 113545891 A CN113545891 A CN 113545891A CN 202110839423 A CN202110839423 A CN 202110839423A CN 113545891 A CN113545891 A CN 113545891A
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Prior art keywords
tip
outer tube
transcatheter valve
delivery system
control assembly
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CN202110839423.2A
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CN113545891B (en
Inventor
潘湘斌
朱达
潘家华
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Fuwai Yunnan Cardiovascular Hospital
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Fuwai Yunnan Cardiovascular Hospital
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436Deployment by retracting a sheath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

本发明属于医疗器械技术领域,特别涉及经导管心脏瓣膜植入技术领域,具体涉及一种新型经导管瓣膜输送系统。本发明提供了一种新型经导管瓣膜输送系统,包括近端部分和远端部分,所述近端部分设置有第一控制组件和第二控制组件,所述远端部分包括外管和尖端,所述尖端设置在所述外管的远端,所述第一控制组件与所述外管连接,控制所述外管的轴向移动;所述第二控制组件与所述尖端连接,控制所述尖端的轴向移动。可通过操作精细释放瓣膜近端部分,以实现经导管瓣膜快速释放与精细释放的需要。

Figure 202110839423

The invention belongs to the technical field of medical devices, in particular to the technical field of transcatheter heart valve implantation, and in particular to a novel transcatheter valve delivery system. The present invention provides a novel transcatheter valve delivery system comprising a proximal portion and a distal portion, the proximal portion is provided with a first control assembly and a second control assembly, the distal portion includes an outer tube and a tip, The tip is arranged at the distal end of the outer tube, the first control component is connected with the outer tube, and controls the axial movement of the outer tube; the second control component is connected with the tip and controls the outer tube. the axial movement of the tip. The proximal portion of the fine-release valve can be manipulated to meet the needs of both rapid and fine-release transcatheter valves.

Figure 202110839423

Description

Novel transcatheter valve delivery system
Technical Field
The invention belongs to the technical field of medical equipment, particularly relates to the technical field of transcatheter heart valve implantation, and particularly relates to a novel transcatheter valve conveying system.
Background
With the development of socioeconomic and the aging of population, the incidence rate of valvular heart disease is obviously increased, and researches show that the incidence rate of valvular heart disease of the old people over 75 years old is up to 13.3%. At present, the traditional surgical treatment is still the first treatment method for patients with severe valvular diseases, but for the patients with advanced age, complicated multiple organ diseases, chest-open operation history and poor cardiac function, the traditional surgical treatment has high risk and high death rate, and some patients even have no operation chance.
Transcatheter heart valve replacement has the advantages of no need of thoracotomy, small wound, quick recovery of patients and the like, and is widely concerned by experts and scholars. In heart valve replacement surgery, precise release of the prosthetic valve is required. Due to the complex anatomy of the human body, prosthetic valves are often designed with irregular shapes. For example, to achieve anchoring of the prosthetic valve, it is designed to conform to the shape of the anatomy, and the cross-section of the stent is designed to be D-shaped, polygonal, etc. In order to allow for accurate delivery of an irregular cross-section prosthetic valve to an anatomical site, a long delivery system time is required. The traditional conveying system is generally designed in a spiral manner, and the retraction and release of the valve are realized by adopting a sheath-tube integrated design; the same valve requires a longer valve to be taken into the capsule, while releasing the valve requires a longer time to operate; in addition, because heart chambers of different valve positions and different pathological conditions are different in size, when the size of the conveying system is not matched with the heart chamber of a patient, the apparatus is easy to cause heart injury, and even the patient can not perform an operation.
Disclosure of Invention
In order to solve the problems mentioned in the background art, the invention provides a novel transcatheter valve delivery system, which reduces the requirements on the size of a heart chamber, improves the release efficiency of the transcatheter valve, reduces the risk of generating complications and improves the success rate of the operation.
In view of the above problems, the present invention provides a novel transcatheter valve delivery system, comprising a proximal portion provided with a first control assembly and a second control assembly, and a distal portion comprising an outer tube and a tip disposed at a distal end of the outer tube, the first control assembly being connected to the outer tube for controlling axial movement of the outer tube; the second control assembly is coupled to the tip to control axial movement of the tip.
As a preferred technical solution, the distal end of the tip is configured as a vertebral body structure, the tip is configured as a hollow structure with an opening at the proximal end, and the hollow cavity of the tip is configured as a first inner cavity.
As a preferred technical solution, the outer tube is configured as a hollow tubular structure, the distal end of the outer tube is provided with an opening, and the opening structure of the distal end of the outer tube and the opening structure of the proximal end of the tip are cooperatively configured.
As a preferred technical scheme, a fixing block is arranged inside the outer tube, the fixing block is fixedly arranged inside the cavity of the outer tube, and a space between the fixing block and the far end of the outer tube is a second inner cavity.
As a preferred solution, the transcatheter valve is arranged in the first and second lumens, with 1-50% of the total volume of the transcatheter valve being arranged in the first lumen and the remainder of the total volume of the transcatheter valve being arranged in the second lumen.
As a preferred aspect, the distal portion further comprises a first inner tube and a second inner tube coaxially disposed within and coaxially with the outer tube.
As a preferable technical scheme, the first inner tube and the second inner tube penetrate through the fixing block, the first inner tube is arranged inside the second inner tube, the distal end of the first inner tube is fixedly connected with the tip, and the distal end of the second inner tube is fixedly connected with the fixing block.
As a preferred technical solution, the first control assembly is connected with the first inner tube, and controls the axial movement of the tip by controlling the axial movement of the first inner tube; the second control assembly is connected with the second inner pipe, and controls the axial movement of the fixing block and the outer pipe by controlling the axial movement of the second inner pipe.
As a preferred technical solution, the first control component is provided as a sliding component, which slides along the axial direction to control the axial sliding of the tip; the second control assembly is provided as a sliding member that slides in the axial direction to control the axial sliding of the outer tube.
As a preferred technical solution, the first control component is provided as a sliding component, which slides along the axial direction to control the axial sliding of the tip; the second control assembly is arranged as a rotating component, and a rotating shaft of the rotating component is the same as or perpendicular to the axial direction of the outer pipe.
Has the advantages that: the present invention provides a novel transcatheter valve delivery system for deploying and releasing a transcatheter valve having self-expanding capabilities, comprising a distal portion and a proximal portion. The distal portion is provided with an inner tube and an outer tube for delivery of the transcatheter valve, and the proximal portion is used to control the retraction or release of the distal portion into or out of the transcatheter valve. The distal portion can be divided into two parts, the transcatheter valve can be respectively retracted or released, the operation of the proximal portion can realize the rapid release of the distal portion of the transcatheter valve, and then the operation of the proximal portion of the fine release valve can realize the requirements of rapid release and fine release of the transcatheter valve.
Drawings
FIG. 1 is a schematic structural view of a novel transcatheter valve delivery system;
FIG. 2 is a schematic structural view of a distal portion of the novel transcatheter valve delivery system;
FIG. 3 is a schematic structural view of a proximal portion of the novel transcatheter valve delivery system;
FIG. 4 is a schematic structural view of a proximal portion of the novel transcatheter valve delivery system; (ii) a
FIG. 5 is a schematic structural view of a proximal portion of the novel transcatheter valve delivery system;
1-a distal portion; 11-an outer tube; 12 — a second inner tube; 13-fixed block; 14 — a first inner tube; 15-tip; 2-a proximal portion; 21 — a second control assembly; 22-first control Assembly
Detailed Description
A novel transcatheter valve delivery system for deploying and releasing a transcatheter valve having a self-expanding function, comprising a proximal portion 2 and a distal portion 1, the proximal portion 2 being provided with a first control member 22 and a second control member 21, the distal portion 1 comprising an outer tube 11 and a tip 15, the tip 15 being arranged at a distal end of the outer tube 11, the first control member 22 being connected to the outer tube 11 for controlling an axial movement of the outer tube 11; the second control assembly 21 is coupled to the tip 15 and controls the axial movement of the tip 15.
In some preferred embodiments, the distal end of the tip 15 is configured as a vertebral body structure, the tip 15 is configured as a hollow structure with an opening at the proximal end, and the hollow cavity of the tip 15 is configured as a first lumen.
In some preferred embodiments, the outer tube 11 is provided as a hollow tubular structure, the distal end of the outer tube 11 is provided with an opening, and the opening structure at the distal end of the outer tube 11 and the opening structure at the proximal end of the tip 15 are cooperatively provided.
In some preferred embodiments, a fixing block 13 is disposed inside the outer tube 11, the fixing block 13 is fixedly disposed inside the cavity of the outer tube 11, and a space between the fixing block 13 and the distal end of the outer tube 11 is provided as a second inner cavity.
In some preferred embodiments, the transcatheter valve is disposed in the first lumen and the second lumen, 1-50% of a full volume of the transcatheter valve is disposed in the first lumen, and a remainder of the full volume of the transcatheter valve is disposed in the second lumen.
During the releasing process of the transcatheter valve, the first control device is firstly operated to lead the tip to move towards the far end, so as to release part of the valve in the first inner cavity, and then the second control device is operated to lead the outer tube to move towards the near end, so as to release the rest part of the valve, thereby completing the releasing process of the whole transcatheter valve.
In some preferred embodiments, the distal portion 1 further comprises a first inner tube 14 and a second inner tube 12, the first inner tube 14 and the second inner tube 12 being coaxially arranged inside the outer tube and coaxially arranged with the outer tube 11.
In some preferred embodiments, the first inner tube 14 and the second inner tube 12 are disposed through the fixing block 13, the first inner tube 14 is disposed inside the second inner tube 12, the distal end of the first inner tube 14 is fixedly connected to the tip 15, and the distal end of the second inner tube 12 is fixedly connected to the fixing block 13.
In some preferred embodiments, the first control assembly 22 is coupled to the first inner tube 14, and controls the axial movement of the tip 15 by controlling the axial movement of the first inner tube 14; the second control assembly 21 is connected to the second inner tube 12, and controls the axial movement of the fixing block 13 and the outer tube 11 by controlling the axial movement of the second inner tube 12.
In some preferred embodiments, the first control assembly 22 is provided as a sliding member that slides axially to control the axial sliding of the tip 15; the second control member 21 is provided as a sliding member that slides in the axial direction to control the axial sliding of the outer tube 11.
In some preferred embodiments, the first control assembly 22 is provided as a sliding member that slides axially to control the axial sliding of the tip 15; the second control assembly 21 is provided as a rotary member having a rotation axis that is the same as or perpendicular to the axial direction of the outer tube 11.
In some preferred embodiments, as shown in fig. 3, the first control assembly 22 is provided as a sliding member that slides axially to control the axial sliding of the tip 15; the second control assembly 21 is provided as a rotating member, and the rotating shaft of the rotating member is in the same axial direction as the outer tube 11; specifically, the first control assembly is of a sleeve shaft sliding block structure, and the second control assembly is of a ball wire steel structure.
In some preferred embodiments, as shown in fig. 4, the first control assembly 22 is provided as a sliding member that slides axially to control the axial sliding of the tip 15; the second control assembly 21 is provided as a sliding member that slides in the axial direction to control the axial sliding of the outer tube 11; specifically, the first control assembly and the second control assembly are arranged to be of a sleeve shaft sliding block structure.
In some preferred embodiments, as shown in fig. 5, the first control assembly 22 is provided as a sliding member that slides axially to control the axial sliding of the tip 15; the second control assembly 21 is provided as a rotating member having a rotation axis perpendicular to the axial direction of the outer tube 11; specifically, the first control assembly is arranged into a sleeve shaft sliding block structure; the second control component is arranged in a knob structure.
The working principle is as follows: the present invention provides a novel transcatheter valve delivery system for deploying and releasing a transcatheter valve having a self-expanding function, comprising a distal portion and a distal portion. The distal portion is provided with an inner tube and an outer tube for delivery of the transcatheter valve, and the proximal portion is used to control the retraction or release of the distal portion into or out of the transcatheter valve. The distal portion can be retracted or released into or from the transcatheter valve in two parts, the operation of the proximal portion can realize the rapid release of the distal portion of the transcatheter valve, and then the operation of the proximal portion of the fine release valve can realize the requirements of the rapid release and the fine release of the transcatheter valve, reduce the operation time of the transcatheter valve in vivo, reduce the operation risk, reduce the working length of the transcatheter valve delivery system in the heart, and reduce the damage of the wall of the heart chamber caused by the length of the transcatheter valve delivery system.

Claims (10)

1. A novel transcatheter valve delivery system, comprising a proximal portion (2) and a distal portion (1), the proximal portion (2) being provided with a first control assembly (22) and a second control assembly (21), the distal portion (1) comprising an outer tube (11) and a tip (15), the tip (15) being arranged at the distal end of the outer tube (11), the first control assembly (22) being connected to the outer tube (11) for controlling the axial movement of the outer tube (11); the second control assembly (21) is connected to the tip (15) and controls the axial movement of the tip (15).
2. The novel transcatheter valve delivery system according to claim 1, wherein the distal end of the tip (15) is configured as a vertebral body structure, the tip (15) is configured as a hollow structure having an opening at the proximal end, and the hollow cavity of the tip (15) is configured as a first lumen.
3. The novel transcatheter valve delivery system according to claim 2, wherein the outer tube (11) is configured as a hollow tubular structure, the distal end of the outer tube (11) is provided with an opening, and the opening structure of the distal end of the outer tube (11) and the opening structure of the proximal end of the tip (15) are cooperatively configured.
4. The novel transcatheter valve delivery system according to claim 3, wherein a fixation block (13) is arranged inside the outer tube (11), the fixation block (13) is fixedly arranged inside the cavity of the outer tube (11), and a space between the fixation block (13) and the distal end of the outer tube (11) is provided as a second inner cavity.
5. The novel transcatheter valve delivery system of claim 4, wherein the transcatheter valve is disposed in the first lumen and the second lumen, wherein between 1-50% of a full volume of the transcatheter valve is disposed in the first lumen, and wherein a remaining portion of the full volume of the transcatheter valve is disposed in the second lumen.
6. The novel transcatheter valve delivery system according to claim 3, wherein the distal portion (1) further comprises a first inner tube (14) and a second inner tube (12), the first inner tube (14) and the second inner tube (12) being coaxially arranged inside the outer tube and coaxially arranged with the outer tube (11).
7. The novel transcatheter valve delivery system according to claim 3, wherein the first inner tube (14) and the second inner tube (12) are disposed through the fixation block (13), the first inner tube (14) being disposed inside the second inner tube (12), the distal end of the first inner tube (14) being fixedly connected to the tip (15), the distal end of the second inner tube (12) being fixedly connected to the fixation block (13).
8. The novel transcatheter valve delivery system of claim 7, wherein the first control assembly (22) is connected to the first inner tube (14), and wherein axial movement of the tip (15) is controlled by controlling axial movement of the first inner tube (14); the second control assembly (21) is connected with the second inner pipe (12), and controls the axial movement of the fixing block (13) and the outer pipe (11) by controlling the axial movement of the second inner pipe (12).
9. The novel transcatheter valve delivery system of claim 7, wherein the first control assembly (22) is provided as a sliding member that slides axially to control axial sliding of the tip (15); the second control assembly (21) is provided as a sliding member that slides in the axial direction to control the axial sliding of the outer tube (11).
10. The novel transcatheter valve delivery system of claim 7, wherein the first control assembly (22) is provided as a sliding member that slides axially to control axial sliding of the tip (15); the second control assembly (21) is arranged as a rotating component, and the rotating shaft of the rotating component is the same as or perpendicular to the axial direction of the outer pipe (11).
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Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110307049A1 (en) * 2010-06-08 2011-12-15 Stephen Kao Bi-directional stent delivery system
US20130274870A1 (en) * 2010-09-24 2013-10-17 Symetis Sa Stent Valve, Delivery Apparatus and Method Therefor
CN103491903A (en) * 2011-04-21 2014-01-01 美敦力公司 Transcatheter prosthetic heart valve delivery system and method with controlled expansion of prosthetic heart valve
CN103501730A (en) * 2011-04-21 2014-01-08 美敦力公司 Transcatheter prosthetic heart valve delivery system with flush port
CN204600795U (en) * 2015-04-20 2015-09-02 上海纽脉医疗科技有限公司 A kind of conveyer device for insertion type artificial cardiac valve
CN204814284U (en) * 2015-07-27 2015-12-02 上海纽脉医疗科技有限公司 Artificial heart valve conveyor
CN105283154A (en) * 2013-06-13 2016-01-27 卡蒂亚蒂斯股份有限公司 Stent delivery system
CN109475419A (en) * 2016-05-13 2019-03-15 耶拿阀门科技股份有限公司 For delivering the heart valve prosthesis delivery system and method for heart valve prosthesis by guide sheath and Load System
CN110755185A (en) * 2018-07-27 2020-02-07 先健科技(深圳)有限公司 Conveying system
CN112451174A (en) * 2020-12-11 2021-03-09 启晨(上海)医疗器械有限公司 Interventional transapical artificial heart valve conveying system
CN212996892U (en) * 2020-10-12 2021-04-20 宁波健世生物科技有限公司 Valve conveying system capable of adjusting positioning
CN113101012A (en) * 2021-03-09 2021-07-13 金仕生物科技(常熟)有限公司 Transcatheter heart valve delivery system

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110307049A1 (en) * 2010-06-08 2011-12-15 Stephen Kao Bi-directional stent delivery system
US20130274870A1 (en) * 2010-09-24 2013-10-17 Symetis Sa Stent Valve, Delivery Apparatus and Method Therefor
CN103491903A (en) * 2011-04-21 2014-01-01 美敦力公司 Transcatheter prosthetic heart valve delivery system and method with controlled expansion of prosthetic heart valve
CN103501730A (en) * 2011-04-21 2014-01-08 美敦力公司 Transcatheter prosthetic heart valve delivery system with flush port
CN105283154A (en) * 2013-06-13 2016-01-27 卡蒂亚蒂斯股份有限公司 Stent delivery system
CN204600795U (en) * 2015-04-20 2015-09-02 上海纽脉医疗科技有限公司 A kind of conveyer device for insertion type artificial cardiac valve
CN204814284U (en) * 2015-07-27 2015-12-02 上海纽脉医疗科技有限公司 Artificial heart valve conveyor
CN109475419A (en) * 2016-05-13 2019-03-15 耶拿阀门科技股份有限公司 For delivering the heart valve prosthesis delivery system and method for heart valve prosthesis by guide sheath and Load System
CN110755185A (en) * 2018-07-27 2020-02-07 先健科技(深圳)有限公司 Conveying system
CN212996892U (en) * 2020-10-12 2021-04-20 宁波健世生物科技有限公司 Valve conveying system capable of adjusting positioning
CN112451174A (en) * 2020-12-11 2021-03-09 启晨(上海)医疗器械有限公司 Interventional transapical artificial heart valve conveying system
CN113101012A (en) * 2021-03-09 2021-07-13 金仕生物科技(常熟)有限公司 Transcatheter heart valve delivery system

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