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CN-121971782-A - Device for improving balloon trafficability and preparation method thereof

CN121971782ACN 121971782 ACN121971782 ACN 121971782ACN-121971782-A

Abstract

The invention relates to a device for improving balloon trafficability and a preparation method thereof, the device comprises a balloon and a film, the film is of an elastic hollow tubular structure, is tightly sleeved on the outer surface of the balloon in a folded state and generates radial pretightening force on the surface of the balloon in the folded state of the balloon, two ends of the film are respectively fixed on a proximal cone part and a distal cone part of the balloon, and the film is configured to exert radial compression force on the balloon by virtue of elastic restoring force of the film when the balloon is depressurized so as to assist the balloon to restore to the folded state. The device provided by the invention can improve the trafficability of the balloon with low compliance, and can avoid the problem of difficult balloon retraction to a great extent.

Inventors

  • WANG XIULI
  • WU XIAO
  • LI CHUNMING

Assignees

  • 上海珀利医用材料有限公司

Dates

Publication Date
20260505
Application Date
20260202

Claims (10)

  1. 1. The device for improving the balloon trafficability is characterized by comprising a balloon and a film, wherein the film is of an elastic hollow tubular structure, is tightly sleeved on the outer surface of the balloon in a folded state, and generates radial pretightening force on the surface of the balloon in the folded state of the balloon; The two ends of the film are respectively fixed on the proximal cone part and the distal cone part of the balloon; Wherein the membrane is configured to exert a radial compressive force on the balloon upon pressure relief of the balloon by means of the elastic restoring force of the membrane itself to assist in restoring the balloon to the folded state.
  2. 2. The device of claim 1, wherein the balloon is made of a low compliance material; Preferably, the low compliance material is selected from any one or a combination of at least two of nylon, polyether block polyamide or polyethylene terephthalate.
  3. 3. The device according to claim 1 or 2, wherein the membrane is made of an elastomeric material; preferably, the elastomeric material has an elongation at break of not less than 400% and a strain hysteresis of not more than 10%; Further preferably, the elastomeric material has an elongation at break of 400% to 800% and a strain hysteresis of not more than 8%.
  4. 4. A device according to claim 3, wherein the elastomeric material is selected from any one or a combination of at least two of latex, silicone or polyurethane.
  5. 5. The device of any one of claims 1-4, wherein the membrane, after being positioned over the balloon in the collapsed state, generates a radial preload force of 0.01-0.5N on the balloon surface.
  6. 6. The device of any one of claims 1-5, wherein the membrane has a recoverable expansion ratio of 5-15.
  7. 7. The device of any one of claims 1-6, wherein the membrane is tightly wrapped with its inner circumference around the outer circumference of the balloon in the folded state, wherein the inner diameter of the membrane in the free state is no greater than the outer diameter of the balloon after folding.
  8. 8. The device of any one of claims 1-7, wherein the film has a thickness of 0.1-1mm; preferably, the length of the film is the distance from the proximal balloon weld to the distal balloon weld.
  9. 9. The device of any one of claims 1-8, wherein the membrane is attached to the balloon by gluing, thermal welding, laser welding, or ultrasonic welding.
  10. 10. A method of preparing a device for enhancing balloon trafficability according to any one of claims 1 to 9, wherein the method comprises applying a film on the surface of the balloon after folding to obtain the device.

Description

Device for improving balloon trafficability and preparation method thereof Technical Field The invention relates to the technical field of medical instruments, in particular to a device for improving balloon trafficability and a preparation method thereof. Background Percutaneous Coronary Intervention (PCI) is an important means for treating coronary heart disease. These procedures are often successful, but sometimes suffer from serious complications. INTERV MED APPL SCI published world first-case cases of complications in which stent balloons cannot be retracted "A rare complication: undeflatable balloon of the stent". After the release of the coronary stent, the difficult withdrawal of the stent balloon catheter sometimes occurs in the percutaneous coronary PCI treatment operation process, particularly the occurrence of the chronic total occlusion lesion interventional operation has more opportunities, mainly related to the complexity degree of coronary lesions, and the structural characteristics of the stent balloon system have a certain relationship, such as the hard balloon material makes the outer diameter of the retracted balloon larger and can not smoothly enter the sheath. If the balloon cannot be retracted in the operation, medical accidents are likely to be caused, heart blood of a patient cannot circulate for a long time, artificial myocardial infarction is caused, and life danger is likely to be caused. Not only PCI surgery, but also balloon retraction difficulties can occur in the new vertebroplasty-Vertebroplasty (VBS) procedures. VBS is the support that 2 head ends parcel sacculus were placed to the symmetry in the injury vertebra, can withdraw from the sacculus after expanding the centrum, and the support is stayed in the centrum cavity and is avoided centrum height to lose. If the balloon fails to retract, not only will the procedure time be prolonged, but the risk to the patient will also increase. When the balloon is withdrawn together with the puncture channel, the balloon is withdrawn from the body, and secondary puncture is needed, so that the operation time is prolonged. There are patents attempting to solve this problem, but these methods have generally been considered from the point of view of post-emergence remedial measures such as "puncture balloon sheath" (patent number: CN109938782 a), "a quick-deflation balloon recoil catheter device" (patent number: CN 220159003U), which can solve the balloon retraction difficulty to some extent, but do not solve the problem in essence, and only act as remedial measures after the occurrence of the problem. There is therefore a need for a method to improve the passability of the balloon itself, avoiding the problem of difficult balloon retraction. Disclosure of Invention In order to solve the technical problems, the invention provides a device for improving the trafficability of a balloon and a preparation method thereof. The device provided by the invention can improve the trafficability of the balloon with low compliance, and can avoid the problem of difficult balloon retraction to a great extent. To achieve the purpose, the invention adopts the following technical scheme: in a first aspect, the present invention provides a device for improving balloon trafficability, the device comprising a balloon and a membrane, wherein the membrane is of an elastic hollow tubular structure, is tightly sleeved on the outer surface of the balloon in a folded state, and generates a radial pretightening force on the surface of the balloon in the folded state of the balloon; The two ends of the film are respectively fixed on the proximal cone part and the distal cone part of the balloon; Wherein the membrane is configured to exert a radial compressive force on the balloon upon pressure relief of the balloon by means of the elastic restoring force of the membrane itself to assist in restoring the balloon to the folded state. In the invention, the hollow tubular structure can uniformly distribute the elastic restoring force of the hollow tubular structure along the circumferential direction. When the balloon is depressurized, the contraction force of the film can uniformly and synchronously act on the whole circumference of the outer wall of the balloon, so that irregular folds are extruded towards the central shaft, and the regular folded form is promoted to be restored. The problems of stress concentration, loose wrapping or uneven retraction possibly caused by sheet wrapping or local adhesion are avoided. The tubular structure is geometrically natural in engagement with the cylindrical body of the balloon and the tapered transition section. During balloon inflation and retraction, the tubular membrane can follow the geometric changes of the balloon surface with minimal internal stress changes, reducing the risk of the membrane twisting, wrinkling or separating from the balloon surface due to geometric mismatch. The two ends of the hollow tubular film are fi