Low profile delivery system for transcatheter heart valve

• US 9,061,119 B2
• Filed: 10/08/2008
• Issued: 06/23/2015
• Est. Priority Date: 05/09/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Le, Thanh H., Tran, Tri, Cayabyab, Ronaldo, Taylor, David, Vidal, Antonio, Bowes, Robert
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US12/247,846
• Publication Number:
  US 20090281619A1
• Time in Patent Office: 2,449 Days
• Field of Search: 623/2.11, 623/2.1, 623/1.11, 623/1.23
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A heart valve delivery apparatus includes a valve carrying member. A prosthetic valve is crimped onto the valve carrying member at a location that is distal or proximal to the balloon member, thereby providing a smaller profile delivery apparatus.

Claims

1. An apparatus for implanting a prosthetic heart valve within a native aortic valve, comprising:

a steerable guide catheter having a handle portion and an elongated guide tube extending from the handle portion, the elongated guide tube having a distal end portion comprising a steerable section, the guide catheter further comprising an adjustment knob on the handle portion and a pull wire operatively connecting the adjustment knob to the steerable section for producing movement of the steerable section via manual adjustment of the adjustment knob;

a balloon catheter sized to slidably extend through the guide catheter, the balloon catheter comprising a proximal portion configured to be positioned adjacent the handle portion and an elongated shaft configured to extend through the elongated guide tube, the balloon catheter further comprising an inflatable balloon positioned along a distal end portion and an extension portion positioned between the elongated shaft of the balloon catheter and the inflatable balloon, the extension portion an integral piece of the balloon having a smaller cross-section than the inflatable balloon;

a nose piece disposed at a distal end of the balloon catheter, the nose piece comprising a tapered distal end and a tapered proximal section having a concave portion, a distal end of the inflatable balloon secured to the nose piece, the nose piece more rigid than the balloon; and

a prosthetic heart valve comprising an expandable frame portion and an inner portion that includes leaflets;

wherein the prosthetic heart valve is sized to be crimped coaxially on the extension portion of the balloon catheter to a diameter substantially smaller than a diameter to which the prosthetic heart valve is crimpable over the inflatable balloon, and wherein a distal end of the elongated guide tube is sized to contact a wire frame of the prosthetic heart valve such that advancement of the guide tube relative to the balloon catheter causes the prosthetic heart valve to be pushed off the extension portion and on to the inflatable balloon for radial expansion of the prosthetic heart valve.

2. The apparatus according to claim 1, wherein the extension portion is formed of a polymer material.

3. The apparatus according to claim 2, wherein the extension portion is formed of nylon.

4. The apparatus according to claim 3, wherein the inflatable balloon is formed of nylon.

5. The apparatus according to claim 4, wherein the extension portion is attached to the elongated shaft of the balloon catheter at bond areas.

6. The apparatus according to claim 1, wherein the inflatable balloon is attached at a mid-point of the nose piece.

7. The apparatus according to claim 1, wherein the concave portion is dimensioned to receive a portion of the inflatable balloon when the crimped prosthetic heart valve abuts the proximal portion of the nose piece.

8. The apparatus according to claim 1, wherein the prosthetic heart valve is crimpable entirely on the extension portion.

9. An apparatus for implanting a prosthetic heart valve within a native aortic valve, comprising:

a guide catheter comprising an elongate guide tube;

a balloon catheter comprising an elongate shaft, the elongate shaft slidably disposable through the elongate guide tube of the guide catheter and extendable therethrough;

a nose piece disposed at a distal end of the elongated shaft of the balloon catheter, the nose piece comprising a tapered distal end and a concave proximal section; and

an inflatable balloon proximal of the nose piece and disposed around the elongate shaft, a distal end of the inflatable balloon secured to the nose piece, the nose piece is more rigid than the inflatable balloon;

an extension portion proximal of the inflatable balloon, a diameter of the extension portion smaller than a diameter of the inflatable balloon, the extension portion integral with the inflatable balloon; and

a prosthetic heart valve comprising an expandable frame portion and an inner portion, the inner portion including leaflets,

wherein

the prosthetic heart valve is coaxially crimpable on the extension portion of the balloon catheter to a diameter substantially smaller than a diameter to which the prosthetic heart valve is coaxially crimpable over the inflatable balloon,

a distal end of the elongated guide tube is dimensioned to contact a wire frame of the prosthetic heart valve such that advancing the guide tube relative to the balloon catheter pushes the prosthetic heart valve from the extension portion to the inflatable balloon, and

a portion of the inflatable balloon is receivable in the concave section of the nose piece when the crimped prosthetic heart valve abuts the nose piece.

10. The apparatus of claim 9, further comprising a plurality of bond areas securing the extension portion to the elongate shaft.

11. The apparatus of claim 9, wherein a distal portion of the elongate guide tube is a steerable section, the guide catheter further comprising at least one pull wire connecting the steerable section to an adjustment knob at a proximal end of the apparatus, the adjustment knob operable to bend the steerable section.

12. The apparatus of claim 9, wherein the inflatable balloon and extension portion comprise a polymer material or nylon.