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Balloon catheter

一种囊体、导管的技术，应用在导管、气球形导管、手术等方向

Inactive Publication Date: 2016-11-30
ABBOTT CARDIOVASCULAR
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] One difficulty, however, is balancing the often conflicting properties of strength and flexibility of catheter shafts
Another challenge is to provide a flexible transition that improves catheter maneuverability yet has a sufficiently strong transition bond
Additionally, the use of multiple shaft sections can be the cause of undesired kinks along the length of the catheter, and if there are any flaws in the bonds between the sections, these joints can be failure-causing (e.g., rupture) Location

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0093] The burst pressure of balloon catheters prepared according to the disclosed subject matter with balloons of various sizes was tested according to ISO 10555-4:2013 and the results are shown in Table 1 . As described herein above, the balloon catheter includes a unitary single-layer distal outer member 230 necked along its entire length (comprising 72D); and a hypotube comprising a cutting portion defined by a first angled cut, an axial cut, and a second angled cut. As demonstrated by the data in Table 1, balloon catheters according to the presently disclosed subject matter provide burst pressures that are significantly higher than the acceptance criteria for typical inflation pressures used in medical procedures (ie, 16 atmospheres). For example, the average burst pressures are 41 atmospheres, 44 atmospheres, and 41 atmospheres for balloons with diameters of 2.5 mm, 3.0 mm, and 3.5 mm, respectively.

[0094]

[0095] Table 1

example 2

[0097] A POC tensile test was performed on the distal balloon seal (i.e., soft tip) and proximal balloon seal of a 2.5 mm x 28 mm balloon prepared according to the disclosed subject matter according to ISO 10555-1:2013, and the results are in shown in Table 2. As described herein above, the balloon catheter includes a unitary single-layer distal outer member 230 necked along its entire length (comprising 72D); and a hypotube comprising a cutting portion defined by a first angled cut, an axial cut, and a second angled cut. As demonstrated by the data in Table 2, balloon catheters according to the presently disclosed subject matter provided tensile strengths significantly above the acceptance criteria required for typical medical procedures. For example, 4.5lb f The average proximal (distal) capsule seal strength is greater than 2.02lb f acceptance criteria, and 1.0lb f Average proximal capsule seal strength greater than 0.5 lb f Acceptance Criteria.

[0098]

[0099] ...

example 3

[0101] Catheter performance was tested against 3.0 mm and 3.5 mm balloons prepared in accordance with the disclosed subject matter using a simulated artery model that exposed the device to conditions similar to those expected during coronary artery surgery in patients Down. For example, models are designed with challenges such as tortuosity and artificial sick areas. The farther the capsule (and scaffold) can be transported in the phantom, the better the performance of the capsule. As described herein above, a balloon catheter according to the disclosed subject matter includes: a monolithic single-layer distal outer member 230 necked along its entire length (comprising 72D); and a hypotube comprising a cutting portion defined by a first angled cut, an axial cut, and a second angled cut. Balloon catheter performance was also tested for 3.0 mm and 3.5 mm control balloons except The distal outer member of 72D and the sheathed hypotube (without the cutting portion defined by ...

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PUM

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Abstract

The invention relates to a balloon catheter including an outer shaft having a hypotube and a monolithic single-layer distal outer member, a balloon in fluid communication with an inflation lumen, and an inner tubular member having a guidewire lumen defined therethrough. The outer shaft has the inflation lumen defined therethrough. The monolithic single-layer distal outer member is necked to a reduced diameter along an entire length thereof. A proximal end of the monolithic single-layer distal outer member is coupled to the hypotube. A distal section of the hypotube comprises a skive defined by a first angled cut, an axial cut, and a second angled cut. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic single-layer distal outer member. The inner tubular member extends distally from a proximal port in the monolithic single-layer distal outer member through at least a portion of the balloon.

Description

[0001] References to related applications [0002] This application claims priority to US Provisional Patent Application No. 62 / 163,839, filed May 19, 2015, the contents of which are hereby incorporated by reference in their entirety. technical field [0003] The disclosed subject matter relates to medical devices, such as balloon catheters for use in angioplasty and / or stent or scaffold delivery. Background technique [0004] In a percutaneous transluminal coronary angioplasty (PTCA) procedure, a guide catheter is advanced through the patient's vasculature until the distal tip of the guide catheter is seated in the desired coronary artery. A guidewire is advanced out of the distal end of the guide catheter into the coronary artery until the distal end of the guidewire traverses the lesion to be dilated. A dilatation catheter having an expandable balloon on its distal portion is advanced into the coronary anatomy via a previously introduced guidewire until the balloon of th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/10A61M29/02
CPCA61M25/0069A61M2025/0183A61M25/0043A61M25/1027A61M25/104A61M25/0045A61M25/1034
Inventor K·J·威廉斯G·多拉特J·芬内利
Owner ABBOTT CARDIOVASCULAR