Catheter with autoinflating, autoregulating balloon

• US 7,909,794 B2
• Filed: 06/01/2004
• Issued: 03/22/2011
• Est. Priority Date: 04/01/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Corace, Russell A., Briscoe, Roderick E.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US10/858,685
• Publication Number:
  US 20040220522A1
• Time in Patent Office: 2,485 Days
• Field of Search: 604/96.01, 604/247, 604/537, 604/264, 604/103.07, 604/103.06, 604/523, 604/103, 606/192, 606/194, 606/195
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/0075 Valve means
• 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 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An autoinflating catheter and balloon assembly having an autoregulating structure to prevent overinflation of the balloon as a result of variable fluid flow rates through the catheter lumen. A tight-fitting elastomeric balloon is provided on the distal end of the catheter body, and the assembly is constructed so that at least a portion of the fluid flow through the lumen is directed to the balloon to inflate it. As the balloon is inflated, more and more of the fluid flow through the catheter is discharged from the catheter, thereby preventing overinflation of the balloon.

Claims

1. A balloon catheter assembly comprising:

a catheter body having a first lumen extending from a proximal end thereof through at least a portion of the length of the catheter body, the catheter body being provided with a fluid discharge aperture for discharging fluid from the lumen;

a balloon secured to an exterior surface of the catheter body, the balloon being expandable between a relaxed state and an expanded state in response to a positive fluid pressure differential between the interior and the exterior of the lumen;

the catheter body being formed with at least one balloon inflation aperture fluidly interconnecting the lumen and the interior of the balloon such that fluid from the lumen can be received in the balloon through the at least one balloon inflation aperture so as to result in expansion of the balloon from the catheter body; and

an autoregulation valve provided on one of the balloon and the catheter body, the valve being adapted to restrict the flow of fluid through the fluid discharge aperture at fluid pressure differentials lower than a predetermined fluid pressure differential, and to expand a fluid flow path between the lumen and the fluid discharge aperture at pressure differential levels equal to or greater than the predetermined fluid pressure differential;

the first lumen providing fluid flow and fluid communication with the balloon by way of the balloon inflation aperture and to exit the catheter by way of the fluid discharge aperture,

wherein the autoregulation valve comprises a one-way valve including a valve seat provided within the catheter lumen proximally of the fluid discharge aperture, the seat being formed with a valve aperture therein in fluid communication with the lumen and having an internal diameter smaller than that of the lumen, a valve member disposed within the catheter lumen distally of the seat, and a valve spring disposed within the catheter lumen distally of the valve member and adapted to bias the valve member into seating engagement with the seat, the spring being selected to close the valve aperture at pressure levels within the lumen below the predetermined pressure differential, and to permit the valve to be lifted from engagement with the valve seat at pressure levels equal to or greater than the predetermined pressure differential, thereby opening the fluid discharge aperture to flow of fluid from the lumen.

2. A catheter assembly according to claim 1, wherein the bias of the spring is so selected that the valve member will not be lifted from the valve seat until the balloon has been inflated to a predetermined degree.

3. A catheter assembly according to claim 1, wherein the valve member comprises a ball.

4. A catheter assembly according to claim 3, wherein the valve seat is tapered so that the cross-sectional area of the valve aperture is greater at the distal end of the valve seat than the proximal end of the valve seat.

5. A catheter assembly, comprising:

a catheter;

a first lumen extending through the catheter;

a first fluid outlet aperture extending through a wall of the catheter to permit a fluid to exit the catheter assembly;

an internal valve in the lumen that is spaced proximally of the fluid outlet aperture, the internal valve configured to control flow of the fluid through the fluid outlet aperture; and

a balloon connected to the catheter, wherein the balloon is fluidly connected to the lumen through a second fluid outlet aperture of the wall of the catheter to allow inflation of the balloon by the fluid, the first lumen providing fluid flow and fluid communication with the balloon by way of the second fluid outlet aperture and to exit the catheter by way of the first fluid outlet aperture, wherein the internal valve prevents flow of the fluid from the lumen through the first fluid outlet aperture until the balloon has inflated to a predetermined degree and permits the flow of the fluid from the lumen through the second fluid outlet aperture when the balloon is inflated to the predetermined degree.

6. The catheter assembly of claim 5, wherein the balloon inflates at a predetermined fluid pressure differential between a first fluid pressure in the first lumen and a second fluid pressure on the exterior of the balloon.

7. The catheter assembly of claim 6, wherein the internal valve comprises a valve seat and a spring-biased ball biased toward the valve seat.

8. The catheter assembly of claim 7, wherein the ball is retracted from the valve seat when a fluid pressure differential between the first fluid pressure and the second fluid pressure exceeds the predetermined fluid pressure differential.

9. The catheter assembly of claim 8, wherein the valve seat is tapered whereby a fluid flow through the valve and out the first fluid outlet aperture increases as the fluid pressure differential increases.

10. The catheter assembly of claim 5, wherein the internal valve comprises a valve seat and a cone-shaped valve member biased toward the valve seat.

11. The catheter assembly of claim 5, wherein the balloon is fluidly connected to the first lumen by at least one balloon aperture extending through a wall of the catheter.

12. A method of performing retrograde cardioplegia solution perfusion, comprising the steps of:

providing a catheter assembly having a catheter and a balloon coupled to the catheter, the catheter having a first lumen extending there through;

providing a first fluid pathway from the first lumen into the balloon and a second fluid pathway from the first lumen out of the catheter assembly, wherein the first lumen provides fluid flow and fluid communication with the balloon by way of a balloon inflation aperture and to exit the catheter by way of a fluid discharge aperture;

providing an internal valve in the lumen that is spaced proximally of the fluid discharge aperture, the internal valve configured to control flow of a fluid through the second fluid pathway to the fluid discharge aperture;

inserting the catheter into a blood vessel;

inflating the balloon by supplying a cardioplegia solution through the first lumen and the balloon inflation aperture into the balloon;

after inflating the balloon to a predetermined degree, opening the second fluid pathway from the first lumen; and

perfusing the heart with the cardioplegia solution by continuing to supply the cardioplegia solution through the first lumen and through the fluid discharge aperture of the second fluid pathway while the balloon is inflated to the predetermined degree.

13. The method of claim 12, wherein the second fluid pathway increases in size as a supply pressure of the cardioplegia solution increases.

14. The method of claim 13, wherein the internal valve comprises a valve seat and a spring-biased ball.

15. The method of claim 12, wherein the catheter is inserted into a coronary sinus.

16. The method of claim 15, wherein the balloon occludes the coronary sinus when inflated.