US-12616820-B2 - Reinforced balloon catheter

Abstract

A balloon catheter is described having a reinforced, co-axial, duel lumen design. In some embodiments, the balloon catheter includes a purging mechanism designed to purge air from the balloon.

Inventors

• Roland Guyon
• Nelson Peralta
• Raleigh Purtzer

Assignees

• MICROVENTION, INC.

Dates

Publication Date

20260505

Application Date

20230711

Claims (20)

1. 1 . A balloon catheter system, comprising: an outer tubular assembly comprising an inflation lumen; a balloon, wherein a proximal portion of the balloon is affixed to the outer tubular assembly; an inner tubular assembly, wherein a distal portion of the balloon is affixed to the inner tubular assembly; wherein the inner tubular assembly includes a purge port in fluid communication with an interior of the balloon, the purge port comprising a gas-permeable membrane that restricts passage of liquid through the membrane; wherein the distal portion of the balloon is bonded to the gas-permeable membrane; and a de-airing channel in fluid communication with the purge port through which gas expelled from the balloon may exit the balloon catheter system.
2. 2 . The balloon catheter system of claim 1 , wherein the membrane comprises pores sized to accommodate gas passage but not liquid passage.
3. 3 . The balloon catheter system of claim 1 , wherein the inner tubular assembly comprises a guidewire port.
4. 4 . The balloon catheter system of claim 1 , wherein the inner tubular assembly is coaxially inserted within a lumen of the outer tubular assembly.
5. 5 . The balloon catheter system of claim 1 , wherein the de-airing channel allows passage of gas out from a distal end of the inner tubular assembly.
6. 6 . The balloon catheter system of claim 1 , wherein the membrane is adjacent to the balloon.
7. 7 . The balloon catheter system of claim 1 , wherein the balloon is deflated when suction is applied through the inflation lumen.
8. 8 . The balloon catheter system of claim 1 , wherein the de-airing channel is located between the membrane and a structural layer of the inner tubular assembly.
9. 9 . The balloon catheter system of claim 1 , further comprising a radiopaque marker band proximally adjacent the de-airing channel.
10. 10 . The balloon catheter system of claim 1 , further comprising a syringe including an inflation liquid, a syringe plunger, and a metered controller that actuates the syringe plunger to expel a metered dose of the inflation liquid from the syringe to the inflation lumen.
11. 11 . The balloon catheter system of claim 10 , wherein the metered controller comprises a signal corresponding to the metered dose of the inflation liquid.
12. 12 . The balloon catheter system of claim 10 , wherein a portion of the metered controller rotates to deliver the metered dose of the inflation liquid from the syringe.
13. 13 . The balloon catheter system of claim 10 , wherein the metered controller is connected to a syringe flange at a first end and the syringe plunger at a second end.
14. 14 . The balloon catheter system of claim 10 , wherein the metered controller comprises a protruding element and a groove that mate when the metered dose of inflation liquid has been dispensed.
15. 15 . The balloon catheter system of claim 1 , wherein the purge port and the de-airing channel project into a wall of the inner tubular assembly.
16. 16 . The balloon catheter system of claim 15 , further comprising a distal, non-inflatable portion of the balloon bonded at a distal end of the inner tubular assembly and over the de-airing channel.
17. 17 . The balloon catheter system of claim 16 , wherein the membrane spans an entire distal section of the inner tubular assembly.
18. 18 . A balloon catheter system, comprising: an outer tubular assembly comprising an inflation lumen; a balloon, wherein a proximal portion of the balloon is affixed to the outer tubular assembly; wherein an inflation fluid is delivered to the balloon through the inflation lumen; an inner tubular assembly, wherein a distal portion of the balloon is affixed to the inner tubular assembly; wherein the inner tubular assembly includes a purge port in fluid communication with an interior of the balloon, the purge port comprising a gas-permeable membrane that restricts passage of liquid through the membrane; and a de-airing channel in fluid communication with the purge port and in fluid communication with a space external to the balloon catheter system, wherein the purge port and the de-airing channel project into a wall of the inner tubular assembly.
19. 19 . A balloon catheter system, comprising: an outer tubular assembly comprising an inflation lumen; an inflation means, wherein a proximal portion of the inflation means is affixed to the outer tubular assembly; an inner tubular assembly, wherein a distal portion of the inflation means is affixed to the inner tubular assembly; wherein the inner tubular assembly includes a purge port in fluid communication with an interior of the inflation means, the purge port comprising a gas-permeable membrane that restricts passage of liquid through the membrane; and a de-airing means in fluid communication with the purge port and in fluid communication with a space external to the balloon catheter system; a distal-non-inflatable portion of the inflation means bonded at a distal end of the inner tubular assembly and over the de-airing means.
20. 20 . A balloon catheter system, comprising: an outer tubular assembly comprising an inflation lumen; a balloon, wherein a proximal portion of the balloon is affixed to the outer tubular assembly; an inner tubular assembly, wherein a distal portion of the balloon is affixed to the inner tubular assembly; wherein the inner tubular assembly includes a purge port in fluid communication with an interior of the balloon, the purge port comprising a gas-permeable membrane that restricts passage of liquid through the membrane; wherein the membrane spans an entire distal section of the inner tubular assembly; and a de-airing channel in fluid communication with the purge port through which gas expelled from the balloon may exit the balloon catheter system.

Description

RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 16/940,205 filed Jul. 27, 2020 entitled Improved Reinforced Balloon Catheter, which is a continuation of and claims priority to U.S. patent application Ser. No. 15/605,820 filed May 25, 2017 entitled Improved Reinforced Balloon Catheter (now U.S. Pat. No. 10,786,659 Issued Sep. 29, 2020), which claims benefit of and priority to U.S. Provisional Application Ser. No. 62/344,371 filed Jun. 1, 2016 entitled Reinforced Balloon Catheter, and to U.S. Provisional Application Ser. No. 62/380,979 filed Aug. 29, 2016 entitled Porosity Purging System for Catheter, all of which are hereby incorporated herein by reference in their entireties. FIELD OF THE INVENTION The present invention relates to balloon catheters and, more particularly, to balloon catheters for use in neurological procedures. BACKGROUND OF THE INVENTION Balloon catheters are increasingly being employed to conduct neurological procedures in patients. However, the design parameters for balloon catheters intended for use in neurological procedures are significantly different than the design parameters for balloon catheters used in non-neurological procedures such as cardiological procedures. For example, the width of the circulatory system within the neuroanatomy is significantly smaller and more tortuous than the circulatory system in other parts of the body. In order to access the smaller and more tortuous regions of the neuroanatomy, it is necessary to minimize the outer diameter of the balloon catheter while simultaneously maintaining the pushability and trackability of the catheter. Balloon catheters and balloons for neurovasculature use offer particular design complications given the small design profile. Balloon catheters often utilize a purging system to purge residual air from the balloon catheter prior to placement in the vasculature. However, purging systems still may leave an escape path for the balloon inflation media resulting in the balloon deflating in the vasculature. This is of special concern for neurovascular balloons, since such balloons are particularly small any minimal leakage can lead to balloon deflation which can negatively impact the intravascular procedure. Additionally, proper dispensation of inflation media is important to avoid overfilling or underfilling the balloon—this is especially critical with neurovascular balloons given the small size of the balloon. The present invention addresses these and other issues by utilizing a purging system for a balloon catheter which does not lead to balloon deflation and utilizing metered dispensation for precise filling of the balloon with inflation media. OBJECTS AND SUMMARY OF THE INVENTION In one embodiment, the present invention includes a balloon catheter that is operable to use with large gauge guidewires, resists ovalizing and kinking of the inflation and guidewire lumen(s), and deploys with improved pushability and trackability. The present invention according to another embodiment provides a balloon catheter that employs a reinforced, co-axial, duel lumen design. In certain embodiments, the lumens are formed of a multilayer, tubular element in which one of the layers functions, in part, to provide radial reinforcement to the tubular element. In another embodiment of the present invention, the distal portion of an outer lumen is locked or fixed to a portion of an inner lumen. A proximal portion of a balloon is attached to a distal portion of the outer lumen and a distal portion of the balloon is attached to a distal portion of the inner lumen. In another embodiment, a fluid flow passage is provided between the outer lumen and an interior volume of the balloon, and a passage exclusive to gas or air is formed from the interior volume of the balloon longitudinally through a distal portion of the balloon catheter. In certain other embodiments, de-airing channels or features are employed between an exterior surface of the inner lumen and an interior surface of the balloon in order to facilitate purging of gas from the inflation passageway of the balloon catheter. In other embodiments, leak-proofing systems can be included to mitigate or prevent the balloon from leaking and deflating during operation. In another embodiment, a tapered inflation lumen is utilized. In another embodiment, a tapered guidewire lumen is utilized. In another embodiment, both the inflation lumen and guidewire lumen are tapered. The taper can be continuous throughout the lumen(s), or localized within a particular region of the lumen(s). In another embodiment, a balloon catheter includes a membrane which selectively allows the passage of air but retains liquid. The use of this membrane can be beneficial for prepping a balloon catheter for use, where air is purged from the balloon before it is placed in the patient's vasculature. In another embodiment, a syringe which allows metered dispensing of inflation media to a ball