CN-121987320-A - Balloon catheter

CN121987320ACN 121987320 ACN121987320 ACN 121987320ACN-121987320-A

Abstract

The invention relates to the field of electrophysiology catheters, in particular to a balloon catheter. The balloon catheter comprises an operation handle, a balloon electrode assembly and an insertion tube, wherein the balloon electrode assembly comprises a balloon body and electrodes arranged on the surface of the balloon body, the insertion tube is connected between the operation handle and the balloon electrode assembly, the insertion tube comprises an outer tube and an inner tube, the inner tube penetrates through the outer tube, the outer tube comprises a bending section positioned at the distal end side, the inner tube comprises a bending adapting section positioned at the distal end side, the bending adapting section is positioned in the bending section, the bending adapting section is made of hard materials and has a bendable structure, a gap is formed on the tube wall of the bending adapting section by the bendable structure, the inner tube further comprises a flexible sealing tube, the flexible sealing tube is positioned on the radial outer side of the bending adapting section, and the flexible sealing tube is used for preventing fluid in the inner tube from leaking from the gap. The invention mainly solves the technical problems that the inner tube of the balloon catheter is easy to collapse and deform in a tortuous vascular path and can not maintain the shape of an inner cavity.

Inventors

CHEN HAO
Ren Jianding
SONG QING
FENG JUN

Assignees

心航路医学科技(广州)有限公司

Dates

Publication Date: 20260508
Application Date: 20241101

Claims (10)

1. A balloon catheter, comprising: An operation handle; the balloon electrode assembly comprises a balloon body and an electrode arranged on the surface of the balloon body; The insertion tube is connected between the operating handle and the balloon electrode assembly and comprises an outer tube and an inner tube, and the inner tube passes through the outer tube; the outer tube comprises a bending section on the distal side, the inner tube comprises a bending fitting section on the distal side, and the bending fitting section is positioned in the bending section; The inner tube further comprises a flexible sealing tube, the flexible sealing tube is located on the radial outer side of the bending adapting section, and the flexible sealing tube is used for preventing fluid in the inner tube from leaking from the gap.
2. The balloon catheter of claim 1, wherein the bendable structure comprises a plurality of side-by-side wires spirally wound to form a tubular structure.
3. The balloon catheter of claim 2, wherein the wire is a stainless steel wire, a nitinol wire, or a noble metal wire.
4. The balloon catheter of claim 1, wherein the bendable structure is a hypotube structure or a snake bone structure.
5. The balloon catheter of claim 4, wherein the hypotube structure comprises first and second grooves disposed on opposite sides of a tube wall of the curved fitting section, respectively, the first and second grooves having a depth less than a radius of the curved fitting section, the first and second grooves having an offset along an axial direction of the curved fitting section.
6. The balloon catheter of any one of claims 1-5, wherein the hard material is a metallic material.
7. The balloon catheter of any one of claims 1-5, wherein the flexible sealing tube is a polymeric tube.
8. The balloon catheter of any one of claims 1-5, wherein the inner tube comprises a proximal support section connected proximal to the curved fitting section, the proximal support section being a metal tube.
9. The balloon catheter of claim 8, wherein a junction of the proximal support section and the curved fitting section is surrounded by the flexible sealing tube.
10. The balloon catheter of any one of claims 1-5, wherein the balloon electrode assembly comprises a balloon that is inflatable and deflatable, a distal end of the balloon being provided with a distal connection socket, a distal end of the inner tube being secured to the distal connection socket, at least a portion of the curved fitting section being located within the balloon.

Description

Balloon catheter Technical Field The invention relates to the field of electrophysiology catheters, in particular to a balloon catheter. Background Atrial fibrillation, abbreviated as atrial fibrillation, is the most common clinical arrhythmia, and its incidence increases gradually with age. Currently, catheter ablation has become an important treatment modality for atrial fibrillation. The pulse electric field ablation is a new tissue ablation means based on physical energy factors, which mainly uses the irreversible electroporation principle, and the cell membrane is perforated irreversibly by the action of the high-voltage pulse electric field on the cell, so that the cell gradually necroses, and finally the tissue ablation purpose is realized. Pulsed electric field ablation may be achieved through balloon catheters. The balloon catheter generally comprises an operating handle, an insertion tube and a balloon electrode assembly, wherein the insertion tube is connected to the distal end of the operating handle, the balloon electrode assembly is connected to the distal end of the insertion tube, the balloon electrode assembly comprises a balloon body and a flexible circuit board, the balloon body can be inflated and contracted, the flexible circuit board can be supported and positioned, the flexible circuit board is attached to the balloon body, the flexible circuit board is provided with an electrode plate, and the electrode plate can be used for forming a pulse electric field. In some related art, the insertion tube of the balloon catheter may include an outer tube and an inner tube, the outer tube including a support tube section, a bending section, and a balloon connection tube connected in sequence from a proximal end to a distal end. The support tube can bear pushing and pulling acting force and torque to realize the conveying of the insertion tube, the bending tube can be bent to adjust the posture of the balloon electrode assembly, and the balloon connecting tube is connected with the balloon body to play a transitional role. The inner tube passes through the lumen of the outer tube and can axially move in the lumen of the outer tube to support and adjust the balloon electrode assembly, and in some cases, the inner tube can form a fluid channel to enable fluid to enter and exit the balloon body so as to realize filling and shrinkage of the balloon body. In order to meet the bending requirement of the bent pipe body, the inner pipe can be made of a high polymer material to achieve certain bending performance, but for a tortuous vascular path, the inner pipe can possibly generate crumple deformation under the action of torsion or thrust, so that the shape of the inner cavity of the inner pipe cannot be maintained, and further the condition that acting force cannot be effectively transmitted or fluid circulation is not smooth occurs. Disclosure of Invention The invention mainly solves the technical problems that the inner tube of the balloon catheter is easy to collapse and deform in a tortuous vascular path and can not maintain the shape of an inner cavity. In a first aspect, in one embodiment there is provided a balloon catheter. A balloon catheter, comprising: An operation handle; the balloon electrode assembly comprises a balloon body and an electrode arranged on the surface of the balloon body; The insertion tube is connected between the operating handle and the balloon electrode assembly and comprises an outer tube and an inner tube, and the inner tube passes through the outer tube; the outer tube comprises a bending section on the distal side, the inner tube comprises a bending fitting section on the distal side, and the bending fitting section is positioned in the bending section; The inner tube further comprises a flexible sealing tube, the flexible sealing tube is located on the radial outer side of the bending adapting section, and the flexible sealing tube is used for preventing fluid in the inner tube from leaking from the gap. In one embodiment, the bendable structure comprises a plurality of wires arranged side-by-side, the plurality of wires arranged side-by-side being helically coiled to form a tubular structure. In one embodiment, the wire is a stainless steel wire, a nitinol wire, or a precious metal wire. In one embodiment, the bendable structure is a hypotube structure or a snake bone structure. In one embodiment, the hypotube structure includes a first groove and a second groove disposed on opposite sides of a tube wall of the curved fitting section, respectively, wherein the first groove and the second groove have a depth smaller than a radius of the curved fitting section, and the first groove and the second groove have a stagger along an axial direction of the curved fitting section. In one embodiment, the hard material is a metallic material. In one embodiment, the flexible sealing tube is a polymeric tube. In one embodiment, the inner tube comprises a proximal support sectio