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CN-122005005-A - Integrated forward shock wave and radial shock wave's of sacculus integrated pipe

CN122005005ACN 122005005 ACN122005005 ACN 122005005ACN-122005005-A

Abstract

The invention discloses an integrated catheter integrating forward shock waves and balloon radial shock waves, which comprises a catheter, a balloon and a control handle, wherein the catheter comprises an inner tube and an outer tube, a guide wire is arranged in the inner tube, the balloon is arranged outside the inner tube at the front end of the catheter, a discharge electrode group and a developing ring are arranged in the inner tube, the discharge electrode is connected with the control handle through an electric wire arranged in the outer catheter, the control handle is used for being connected with an external energy device, after the balloon is filled with liquid, the shock waves are generated through the discharge electrode group, and are conducted to the surface of the balloon and the tip of the front part of the catheter through fluid in the balloon, so that substances contacting the outer part of the balloon or the tip of the catheter are softened, cracked or broken. The integrated catheter integrates two functional modules into a single instrument, and can start the forward shock wave module first and then start the radial shock wave module when facing to extremely narrow or CTO lesions where the guide wire can pass but the balloon is difficult to pass, thereby greatly simplifying the operation flow.

Inventors

  • LI YONG
  • HUO YONG

Assignees

  • 江苏省人民医院（南京医科大学第一附属医院）

Dates

Publication Date
20260512
Application Date
20260226

Claims (10)

  1. 1. An integrated catheter integrating forward shock waves and balloon radial shock waves is characterized by comprising a catheter, a balloon and a control handle; The guide wire extends out of the tail part of the guide tube, and can push the guide tube to move forwards through the guide wire; The saccule is arranged outside the inner tube at the front end of the catheter, the inner tube is internally provided with a discharge electrode group and a developing ring, The discharge electrode is connected with the control handle through an electric wire arranged in the outer catheter, the balloon is communicated with a water inlet cavity and a water discharge cavity which are arranged in the outer catheter, liquid is injected through the water inlet cavity, and air in the balloon is discharged through the water discharge cavity; The control handle is used for being connected with an external energy device, after the balloon is filled with liquid, the control handle is communicated with the energy device, shock waves are generated through the discharge electrode group, the shock waves are conducted to the surface of the balloon and the tip of the front part of the catheter through fluid in the balloon, and substances contacting the outer part of the balloon or the tip of the catheter are softened, cracked or broken.
  2. 2. The integrated forward shock wave and balloon radial shock wave catheter according to claim 1, wherein the balloon is cylindrical in the middle, conical at two ends, foldable before liquid injection, the tip of the front cone catheter connected with the inner tube, and the cone at the rear end connected with the outer tube.
  3. 3. The integrated forward shock wave and balloon radial shock wave catheter of claim 2, wherein the diameter of the balloon middle cylinder is 1-15 mm and the length is 5-100 mm.
  4. 4. The integrated catheter integrating forward shock waves and balloon radial shock waves according to claim 1, wherein the discharge electrode group comprises more than two discharge electrodes, the discharge electrodes are sleeved on the inner tube in a circular ring structure, a first discharge electrode is positioned at a position, close to the tip of the catheter, of the inner tube, the front part of the first discharge electrode and the radial balloon are forward shock wave bands, the rest part of the balloon is radial shock wave bands, the second electrode and the rest electrodes are distributed in the radial shock wave bands of the balloon, and developing rings are respectively arranged on the inner tube at two ends of the second electrode and the rest electrodes; The hardness of the material used for the forward shock wave band of the balloon is higher than that of the material used for the radial shock wave band.
  5. 5. The integrated catheter integrating forward shock waves and balloon radial shock waves according to claim 4, wherein the electrodes are of a three-layer concentric ring structure, and are an outer electrode, an insulating layer and an inner electrode from outside to inside respectively, and when the outer electrode and the inner electrode are in instant high voltage communication with an energy device, gaps between the inner electrode and the outer electrode at two end surfaces are broken down to generate electric arcs and further generate shock waves; The first electrode is controlled by a single loop, and the rest electrodes are connected in series by a complete loop.
  6. 6. The integrated catheter integrating forward shock waves and balloon radial shock waves according to claim 4, wherein the three layers of concentric circular ring structures are 1-5 mm in length and are fixed by glue bonding.
  7. 7. The integrated forward shock wave and balloon radial shock wave catheter of claim 4, wherein the first discharge electrode is provided with a reflective ring, the reflective ring is arranged on one side of the first discharge electrode far away from the catheter tip, the reflective ring is provided with an outward radial end face facing the catheter tip, and when the first discharge electrode generates shock waves, part of the shock waves are emitted out through the end face of the reflective ring facing the front of the catheter.
  8. 8. The integrated forward shock wave and balloon radial shock wave catheter of claim 4 wherein the developing ring is made of platinum iridium alloy, gold or tantalum.
  9. 9. The integrated forward shock wave and balloon radial shock wave catheter of claim 4 wherein the forward shock band is made of polyethylene terephthalate or nylon material and the radial shock band is made of polyurethane, silicone or polyether block polyamide material.
  10. 10. The integrated forward shock wave and balloon radial shock wave catheter of claim 1, wherein the inner tube is a single-lumen tube with a diameter of 0.4-1.5 mm, the outer tube is a multi-lumen tube, the outer tube is connected with the inner tube and positioned at the rear of the catheter, the integrated forward shock wave and balloon radial shock wave integrated catheter comprises a guide wire cavity, a water inlet cavity, a water outlet cavity and a wire cavity passing through wires, the tail of the outer tube is a base, and the guide wire cavity, the water inlet cavity, the water outlet cavity and the wire cavity are respectively opened at the base.

Description

Integrated forward shock wave and radial shock wave's of sacculus integrated pipe Technical Field The invention belongs to the field of medical instruments, and particularly relates to an integrated catheter integrating forward shock waves and balloon radial shock waves. Background Calcified lesions of coronary and peripheral arteries are a major challenge in interventional procedures. Wherein the coronary artery calcification accounts for 25% -30% of the coronary artery interventional therapy, and 8% -10% of the coronary artery calcification is severe calcification. The prevalence of arterial calcification is significantly increased in 47% to 72% of patients with peripheral arterial disease, particularly in advanced age, diabetes, chronic kidney disease, obesity and dyslipidemia. Arterial calcification brings great challenges to vascular interventional therapy, is one of the main reasons of operation failure, and serious calcification lesions or lesion tortuosity angulation combined calcification are encountered in the operation process, so that balloon expansion difficulty and stent passing difficulty are caused, poor stent adhesion or incomplete expansion is caused after the stent is placed, and serious thrombosis or restenosis in the stent even occur, and risks such as arterial dissection, perforation and the like exist. Current interventional treatment methods for vascular calcification include simple balloon dilation, cutting or special balloon dilation of spinous processes, etc., rotational atherectomy (rotational atherectomy, RA), excimer laser ablation of coronary plaque, rotational atherectomy of coronary artery, and balloon endovascular lithotripsy (IVL), etc. While these therapeutic approaches have limited direct clinical benefit, they can increase the likelihood of stent placement, optimize stent expansion and translate into better clinical results. Conventional treatment strategies suffer from various drawbacks, balloon dilation requiring inflation at high pressure (often up to 20atm and beyond) to potentially dilate the vessel. The continuous high pressure expansion causes the surrounding non-calcified portion to be expanded first, which can lead to uneven stress of calcified and non-calcified portions, greatly increasing the risk of dissection and arterial rupture. The cutting saccule and RA or orbital rotational atherectomy are only suitable for superficial calcification of the intima of the blood vessel, are not suitable for calcification of the intima, deep calcification and the like, have complex operation and longer learning curve, and have higher incidence rate of postoperative complications such as vascular perforation, slow blood flow/no-reflow, acute vascular embolism and the like. Intravascular lithotripsy (IVL) is derived from the renal pelvis calculus lithotripsy technique, a new method of treating severe calcified plaque lesions, with the use of acoustic shock waves in balloon delivery systems to break calcium to aid stent expansion and lumen enlargement. IVL can safely and effectively disintegrate superficial and deep calcified rings, and remarkably improve vascular compliance. However, the success of the balloon is premised on the successful passage of the balloon and its arrival at the calcified lesions. In the face of extreme stenosis (e.g., a stenosis of 95% or more) or CTO lesions, the balloon catheter itself may not pass due to size or stiffness issues. Therefore, the forward impact waveguide tube is developed, and the design concept is that the forward emitted impact wave is generated at the tip of the catheter, and the initial channel is firstly vibrated loose and opened up. However, because of the two different IVL catheters, in clinical practice, the physician often needs to alternate between using different instruments (e.g., pass the lesion with the forward catheter and expand with the balloon-type lithotripsy catheter), which increases not only the procedure time, contrast media usage, and X-ray exposure, but also the risk of vessel injury due to multiple instrument exchanges. Object of the Invention The invention aims at overcoming the defects of the prior art and provides an integrated catheter integrating forward shock waves and balloon radial shock waves. In order to achieve the aim, the invention adopts the following technical scheme that the integrated catheter integrating forward shock waves and balloon radial shock waves comprises a catheter, a balloon and a control handle; The guide wire extends out of the tail part of the guide tube, and can push the guide tube to move forwards through the guide wire; The saccule is arranged outside the inner tube at the front end of the catheter, the inner tube is internally provided with a discharge electrode group and a developing ring, The discharge electrode is connected with the control handle through an electric wire arranged in the outer catheter, the balloon is communicated with a water inlet cavity and a water d