CN-122028875-A - Multiple balloon inflation with separate pressure sensors

Abstract

A prosthetic heart valve delivery system can include a handle, an outer catheter extending distally from the handle, and a balloon mounted to a distal portion of the outer catheter. The prosthetic heart valve may be configured to be received on a balloon, and the balloon inflation system may be configured to inflate and deflate the balloon. The balloon may include a proximal balloon portion and a distal balloon portion positioned distally of the proximal balloon portion. The interior volume of the proximal balloon portion may be fluidly isolated from the interior volume of the distal balloon portion such that the proximal balloon portion and the distal balloon portion may be inflated independently of each other.

Inventors

• T. Govik

Assignees

• 圣犹达医疗用品心脏病学部门有限公司

Dates

Publication Date

20260512

Application Date

20241011

Priority Date

20231020

Claims (20)

1. 1. A prosthetic heart valve delivery system, comprising: A handle; an outer catheter extending distally from the handle; a balloon mounted to a distal portion of the outer catheter; a prosthetic heart valve configured to be received on the balloon; a balloon inflation system configured to inflate and deflate the balloon, and Wherein the balloon comprises a proximal balloon portion and a distal balloon portion, the distal balloon portion being positioned distally of the proximal balloon portion and an interior volume of the proximal balloon portion being fluidly isolated from an interior volume of the distal balloon portion such that the proximal balloon portion and the distal balloon portion can be inflated independently of each other.
2. 2. The prosthetic heart valve delivery system of claim 1, wherein the balloon comprises a central balloon portion positioned between the proximal balloon portion and the distal balloon portion, an interior volume of the central balloon portion being fluidly isolated from an interior volume of the proximal balloon portion and an interior volume of the distal balloon portion such that the proximal balloon portion, the central balloon portion, and the distal balloon portion are all inflatable independently of one another.
3. 3. The prosthetic heart valve delivery system of claim 1, further comprising a first sensor operably coupled to the proximal balloon portion and a second sensor operably coupled to the distal balloon portion, the first sensor configured to communicate data indicative of an expanded state of the proximal balloon portion to the balloon inflation system, the second sensor configured to communicate data indicative of an expanded state of the distal balloon portion to the balloon inflation system.
4. 4. The prosthetic heart valve delivery system of claim 3, wherein the first sensor is a first pressure sensor positioned in fluid communication with an interior volume of the proximal balloon portion and the second sensor is a second pressure sensor positioned in fluid communication with an interior volume of the distal balloon portion.
5. 5. The prosthetic heart valve delivery system of claim 1, further comprising a first inflation lumen extending from the balloon inflation system to the proximal balloon portion and a second inflation lumen extending from the balloon inflation system to the distal balloon portion, the balloon inflation system configured to pass inflation medium through the first inflation lumen to the proximal balloon portion and pass inflation medium through the second inflation lumen to the distal balloon portion independent of passing inflation medium through the first inflation lumen to the proximal balloon portion.
6. 6. The prosthetic heart valve delivery system of claim 5, wherein the second inflation lumen is positioned radially inward of the first inflation lumen.
7. 7. The prosthetic heart valve delivery system of claim 5, wherein the first inflation lumen is spaced apart from the second inflation lumen, the first and second inflation lumens extending parallel to one another.
8. 8. The prosthetic heart valve delivery system of claim 7, wherein the proximal balloon portion is annular when inflated and the distal balloon portion is annular when expanded.
9. 9. The prosthetic heart valve delivery system of claim 1, wherein the proximal balloon portion has a first shape when inflated and the distal balloon portion has a second shape when inflated, the first shape and the second shape being the same.
10. 10. The prosthetic heart valve delivery system of claim 1, wherein the distal balloon portion is formed from a plurality of distal radial balloon portions.
11. 11. The prosthetic heart valve delivery system of claim 10, wherein the plurality of distal radial balloon portions are circumferentially spaced apart from one another, the circumferential direction constraining a longitudinal axis passing through a center of the outer catheter.
12. 12. The prosthetic heart valve delivery system of claim 11, wherein the plurality of distal radial balloon portions are fluidly isolated from each other such that each of the plurality of distal radial balloon portions is independently inflatable.
13. 13. The prosthetic heart valve delivery system of claim 12, wherein the distal balloon portion has a rounded outer circumference when each of the plurality of distal radial balloon portions is inflated.
14. 14. The prosthetic heart valve delivery system of claim 10, wherein the proximal balloon portion is formed from a plurality of proximal radial balloon portions.
15. 15. The prosthetic heart valve delivery system of claim 14, wherein the balloon comprises a central balloon portion positioned between the proximal balloon portion and the distal balloon portion, an interior volume of the central balloon portion being fluidly isolated from an interior volume of the proximal balloon portion and an interior volume of the distal balloon portion such that the proximal balloon portion, the central balloon portion, and the distal balloon portion are all inflatable independently of one another, the central balloon portion being formed from a plurality of central radial balloon portions.
16. 16. A method of implanting a prosthetic heart valve, the method comprising: Advancing a delivery catheter through a vasculature of a patient while the prosthetic heart valve is crimped over a balloon of the delivery catheter, the balloon including a proximal balloon portion and a distal balloon portion, the distal balloon portion being positioned distal of the proximal balloon portion; Positioning the prosthetic heart valve within the patient's native valve annulus while the prosthetic heart valve is crimped onto the balloon; Independently advancing inflation medium into the proximal balloon portion and into the distal balloon portion such that the proximal balloon portion expands independently of the distal balloon portion; Determining an inflation state of the proximal balloon portion and an inflation state of the distal balloon portion when the proximal balloon portion and the distal balloon portion are inflating; Comparing the inflation status of the proximal balloon portion with the inflation status of the distal balloon portion to determine if there is an unbalanced balloon inflation, and Upon determining that there is an unbalanced balloon inflation, the inflation rate of one or both of the proximal balloon portion or the distal balloon portion is adjusted to compensate for the unbalanced balloon inflation.
17. 17. The method of claim 16, wherein a first pressure sensor is positioned in fluid communication with the interior volume of the proximal balloon portion and a second pressure sensor is positioned in fluid communication with the interior volume of the distal balloon portion.
18. 18. The method of claim 17, wherein the first pressure sensor communicates pressure information of the proximal balloon portion to a motorized balloon inflation system operatively coupled to the balloon, and the second pressure sensor communicates pressure information of the distal balloon portion to the motorized balloon inflation system.
19. 19. The method of claim 18, wherein the inflation status of the proximal balloon portion is determined based on the communicated pressure information from the first pressure sensor and the inflation status of the distal balloon portion is determined based on the communicated pressure information from the second pressure sensor.
20. 20. The method of claim 19, wherein a processor operatively coupled to the motorized balloon inflation system performs the determination that there is an unbalanced balloon inflation, and upon determining that there is an unbalanced balloon inflation, the processor causes the motorized balloon inflation system to adjust an inflation rate of one or both of the proximal balloon portion or the distal balloon portion.

Description

Multiple balloon inflation with separate pressure sensors Cross Reference to Related Applications The present application claims priority from U.S. provisional patent application No. 63/591,816, filed 10/20 at 2023, the contents of which are incorporated herein by reference. Background Valvular heart disease (particularly aortic valve disease and mitral valve disease) is a significant health problem in the united states. Valve replacement is one option for treating heart valve disease. Prosthetic heart valves include surgical heart valves, and collapsible and expandable heart valves intended for transcatheter aortic valve replacement or implantation ("TAVR" or "TAVI") or transcatheter mitral valve replacement ("TMVR"). For example, surgical heart valves or mechanical heart valves may be sutured into the patient's native valve annulus during open heart surgery. Collapsible and expandable heart valves may be delivered to a patient via a delivery device (e.g., a catheter) to avoid more invasive procedures (e.g., open chest procedures, open heart procedures). As used herein, references to "collapsible and expandable" heart valves include heart valves that are formed with a small cross-section that enables the heart valves to be delivered into a patient through a catheter in minimally invasive surgery and then expanded to an operable state once in place, as well as heart valves that are first collapsed into a small cross-section for delivery into a patient after construction and then expanded to an operable size once in place in the valve annulus. Collapsible and expandable prosthetic heart valves generally take the form of a one-way valve structure (commonly referred to as a valve assembly) mounted into an expandable frame (the terms "stent" and "frame" may be used interchangeably herein). Typically, these collapsible and expandable heart valves include a self-expanding frame, a mechanically expandable frame, or a balloon-expandable frame, typically made of nitinol, or another shape memory metal, or a metal alloy (for self-expanding frames) or steel, or cobalt chrome (for balloon-expandable frames). The one-way valve assembly mounted to/within the stent includes one or more leaflets and may also include a cuff or skirt. The cuff may be disposed on the inner surface or luminal surface of the stent, on the outer surface or luminal surface thereof, and/or on both surfaces. The cuff helps ensure that blood does not merely flow around the valve leaflets if the valve or valve assembly is not optimally seated in the valve annulus. The cuff or a portion of the cuff disposed on the exterior of the stent may help prevent leakage around the exterior of the valve (the latter is referred to as paravalvular leakage or "PV" leakage). Balloon-expandable valves are typically delivered to the native valve annulus while collapsing (or "crimping") onto the deflated balloon of the balloon catheter, with or without the collapsed valve covered by an overlying sheath. Once the crimped prosthetic heart valve is positioned within the annulus of the native heart valve being replaced, the balloon is inflated to force the balloon-expandable valve to transition from a collapsed or crimped state to an expanded or deployed state in which the prosthetic heart valve tends to remain in its shape formed by the balloon expansion. Typically, when the position of the collapsed prosthetic heart valve is determined to be in a desired position relative to the native valve annulus (e.g., via visualization under fluoroscopy), a fluid (typically a liquid, but gas may also be used) (e.g., saline) is pushed through the balloon catheter via a syringe (manually, automatically, or semi-automatically) to initiate filling and expansion of the balloon, thereby expanding the overlying prosthetic heart valve into the native valve annulus. Disclosure of Invention According to one aspect of the present disclosure, a prosthetic heart valve delivery system includes a handle, an outer catheter extending distally from the handle, a balloon mounted to a distal portion of the outer catheter, a prosthetic heart valve configured to be received on the balloon, and a balloon inflation system configured to inflate and deflate the balloon. The balloon may include a proximal balloon portion and a distal balloon portion positioned distally of the proximal balloon portion. The interior volume of the proximal balloon portion may be fluidly isolated from the interior volume of the distal balloon portion such that the proximal balloon portion and the distal balloon portion may be inflated independently of each other. The balloon may include a central balloon portion positioned between the proximal balloon portion and the distal balloon portion. The interior volume of the central balloon portion may be fluidly isolated from the interior volume of the proximal balloon portion and the interior volume of the distal balloon portion such that the proximal balloon portion, the central balloo