CN-122006077-A - Guide tube and delivery system for delivering heart valve prostheses

CN122006077ACN 122006077 ACN122006077 ACN 122006077ACN-122006077-A

Abstract

The invention discloses a guide tube and a conveying system using the guide tube. The guiding tube comprises a tube body, a snake bone tube and an adjusting assembly, wherein the tube body is provided with a first tube cavity, the snake bone tube is provided with a second tube cavity, the tube body of the snake bone tube at least comprises a first tube section and a second tube section, the first tube section and the second tube section are reversely bent when the same traction force is applied, a traction wire penetrates through the first tube cavity and the second tube cavity and is connected with the distal end of the first tube section, the proximal end of the traction wire is connected with a first control piece arranged at the proximal end of the tube body, the adjusting assembly comprises an adjuster and a second control piece, the adjuster is arranged on the outer circumference of the tube body and moves between the proximal end direction and the distal end direction of the tube body along the axial direction of the tube body, a traction hole penetrating through the traction wire and being at a preset radial distance from the outer surface of the tube body is arranged on the adjuster, and after the traction wire is applied to the first control piece, the second control piece controls the adjuster to move along the axial direction close to or away from the snake bone tube so as to achieve the actual axial line of the guiding tube to move towards a preset axial line.

Inventors

ZHANG HUIHAI
SUN JIAKANG
ZHAO ZENG
YE SHENGCHENG

Assignees

北京新尖科技有限公司

Dates

Publication Date: 20260512
Application Date: 20260415

Claims (10)

1. A guide tube, comprising: a tube having a first lumen extending in an axial direction, and proximal and distal ends at either end of the lumen; the snake bone tube is arranged at the distal end of the tube body and is provided with a second tube cavity; a traction wire having a proximal end portion and a distal end portion, the distal end portion penetrating the first lumen and the second lumen and being connected to the distal end of the snake bone tube, the proximal end portion being connected to a first control member disposed proximal to the tube body; The adjusting assembly comprises an adjuster and a second control piece, wherein the adjuster is arranged on the pipe body and can move along the axial direction, the adjuster is provided with a traction hole penetrating through the traction wire, the traction hole is provided with a geometric center which is at a preset radial distance from the outer surface of the pipe body, after the first control piece applies traction to the snake bone pipe through the traction wire, the second control piece adjusts the moment of the far end of the snake bone pipe relative to the near end of the traction wire through changing the position of the adjuster in the axial direction so as to control the actual axial center line of the guide pipe to move towards a preset axial center line.
2. The guide tube according to claim 1, wherein the axial lead of the traction hole on the regulator is parallel to the axial lead of the tube body or forms a pre-inclined angle of 2-8 degrees, and the distance d between the inner wall of the traction hole and the outer surface of the tube body is 0.05-mm-2.3 mm.
3. The guide tube of claim 1, wherein the traction wire rotates in the range of 150-210 degrees in the direction of travel of the snake bone tube and in the direction of travel of the traction hole.
4. A guide tube according to any one of claims 1 to 3, wherein the regulator is of a porous lumen structure, the porous lumen comprising a main bore for nesting with the outer surface of the tube, the traction bore being disposed at the periphery of the main bore.
5. The guide tube according to claim 4, wherein the adjuster is fitted around the outer circumference of the tube body, the adjuster is frictionally coupled to the outer circumference of the tube body, and a frictional force therebetween is satisfied by the second control member being capable of driving the adjuster in an axial direction of the tube body between a proximal direction and a distal direction against the frictional force, and the adjuster is relatively fixed to the tube body when the frictional force is not reached.
6. The guide tube according to claim 4, wherein the adjuster is magnetically suspended around the tube body, a traveling wave magnetic field capable of generating an axial direction is configured between the adjuster and the tube body, a displacement sensor for detecting a gap between the adjuster and the tube body in real time is arranged on the adjuster, and a second control member is in signal connection with the adjuster to control the adjuster to stably suspend on the tube body and freely slide along the axial direction.
7. The guide tube of claim 4, wherein the snake bone tube comprises first and second tube sections and a steering unit knuckle; the first pipe section is provided with a plurality of first unit sections, and the plurality of first unit sections are bent in a first direction when the traction force is applied to the first pipe section to form a first bending section; the second pipe section is provided with a plurality of second unit sections, and the plurality of second unit sections are bent towards a second direction when the traction force is applied to the second pipe section to form a second bending section; The steering unit joint is configured on the second pipe section and is used for further adjusting the bending direction of the second bending section.
8. The guide tube of claim 4, further comprising a hypotube that is sleeved around the tube body and the snake bone tube; the hypotube is provided with a hardening section, a bending section and a income section; The hard adjusting section is sleeved on the periphery of the pipe body, and the snake bone pipe is movable in the bending section and the income section; the bending section and the income section are synchronously bent along with the snake bone pipe.
9. The guide tube of claim 8, wherein anti-rotation segments are provided in the body of the receiving section to prevent rotation of the hypotube.
10. A delivery system for delivering a heart valve prosthesis, comprising the guide tube of any one of claims 1-9, a control handle, and a pull jaw mount for attachment of the valve prosthesis; The proximal end of the tube body of the guide tube is mounted on the control handle, and the first control element and the second control element are coupled to the control handle; the pull claw seat is positioned at one side of the distal end of the snake bone tube and can be close to or far away from the distal end of the snake bone tube along the axial direction in the tube body, and the distal end of the pull claw seat is connected with a heart valve prosthesis.

Description

Guide tube and delivery system for delivering heart valve prostheses Technical Field The invention relates to the field of medical instruments, in particular to a guide tube and a conveying system using the guide tube for conveying a heart valve prosthesis. Background The heart may develop a variety of valve diseases due to congenital or acquired causes that directly or indirectly compromise the physical and mental health of the patient. When valve lesions develop to a severe degree, it is often necessary to replace the diseased native valve with a prosthetic valve prosthesis. At present, percutaneous minimally invasive interventional therapy technology is rapidly developed, and the technology can enter a body through a catheter through a blood vessel or other passages and release a valve prosthesis at a target position, so that treatment of valve diseases is realized. In the process, how to accurately deliver the valve prosthesis to the expected position in the heart through the delivery catheter and how to reasonably utilize the anatomical space such as the atrium to carry out position fine adjustment become key links affecting the success or failure of the operation. Taking tricuspid valve repair as an example, the tricuspid valve anatomy is relatively complex, and the delivery catheter must traverse multiple curved paths to reach the intended location during the interventional procedure. In this procedure, the catheter is subjected to a bend adjustment to accommodate the anatomical trend. However, existing delivery catheters have structural design limitations, and the camber adjustment often causes uncontrolled changes in overall tube morphology, resulting in final positioning of the valve prosthesis from the intended one. In some cases, it is even necessary to rely on extreme dilation of the patient's heart to obtain sufficient working space, which significantly limits the scope and success rate of the procedure. Disclosure of Invention To solve the above technical problem, an aspect of the present invention provides a guide tube, including: a tube having a first lumen extending in an axial direction, and proximal and distal ends at either end of the lumen; the snake bone tube is arranged at the distal end of the tube body and is provided with a second tube cavity; a traction wire having a proximal end portion and a distal end portion, the distal end portion penetrating the first lumen and the second lumen and being connected to the distal end of the snake bone tube, the proximal end portion being connected to a first control member disposed proximal to the tube body; The adjusting assembly comprises an adjuster and a second control piece, wherein the adjuster is arranged on the pipe body and can move along the axial direction, the adjuster is provided with a traction hole penetrating through the traction wire, the traction hole is provided with a geometric center which is at a preset radial distance from the outer surface of the pipe body, after the first control piece applies traction to the snake bone pipe through the traction wire, the second control piece adjusts the moment of the far end of the snake bone pipe relative to the near end of the traction wire through changing the position of the adjuster in the axial direction so as to control the actual axial center line of the guide pipe to move towards a preset axial line. In some embodiments, the axis of the traction hole on the regulator is parallel to the axis of the pipe body or forms a pre-inclined angle of 2-8 degrees, and the distance d between the inner wall of the traction hole and the outer surface of the pipe body is 0.05-mm-2.3 mm. In some embodiments, the regulator is sleeved on the outer circumference of the tube body, the regulator is in friction connection with the outer circumferential surface of the tube body, and the friction force between the regulator and the outer circumferential surface of the tube body is satisfied, the second control member can drive the regulator to move along the axial direction of the tube body between the proximal end direction and the distal end direction of the tube body after overcoming the friction force, and the regulator is relatively fixed on the tube body when the friction force is not reached. In some implementations, the regulator is a porous lumen structure, the porous lumen includes a main hole for sleeving with the outer surface of the tube, and the traction hole is arranged at the periphery of the main hole. In some implementations, the traction holes comprise a pair of through holes which are arranged in parallel, a plurality of groups of traction holes are distributed on the tube body of the porous cavity tube, and the plurality of groups of traction holes are uniformly arrayed on the periphery of the main hole. It should be noted that the traction hole is not limited to the through hole, but may be an open traction groove, an outer convex traction column or a pulley structure, so long