Method of emboli protection using a low profile catheter

• US 6,500,166 B1
• Filed: 12/06/1999
• Issued: 12/31/2002
• Est. Priority Date: 05/20/1996
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Bagaoisan, Celso J., Bleam, Jefferey C., Zadno Azizi, Gholam-Reza
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): BIANCO, PATRICIA
• Application Number:
  US09/455,878
• Time in Patent Office: 1,121 Days
• Field of Search: 604/507-10, 604/96.01, 604/97.01, 604/98.01, 604/99.04, 604/103, 604/104, 604/103-3-1, 604/107, 604/99.01, 604/99.02, 606/191, 606/192-94, 606/198, 606/200, 600/433, 600/435
• US Class Current: 604/509
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09033 with fixed mandrils, e.g. mandrils fixed to tip; Tensionable 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 25/10185 Valves
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Disclosed herein is a low profile catheter valve comprising a movable sealer portion positioned within the inflation lumen of a catheter. The sealer portion forms a fluid tight seal with the inflation lumen by firmly contacting the entire circumference of a section of the inflation lumen. The sealer portion may be positioned proximally of a side-access inflation port on the catheter, to establish an unrestricted fluid pathway between the inflation port and an inflatable balloon on the distal end of the catheter. As desired, the clinician may move the sealer portion to a position distal of the inflation port, thereby preventing any fluid from being introduced into or withdrawn from the balloon via the inflation port.

Claims

1. A method, comprising:

providing a catheter comprising an expandable member and a tubular member, the expandable member connected to the tubular member, the tubular member comprising a lumen having an elongate member therein;

inserting the catheter into a blood vessel;

varying the relative position of the tubular member and the elongate member, while at least a portion of the elongate member remains within the tubular member, to enable the expansion of the expandable member; and

frictionally engaging bends in the elongate member with an interior surface of the tubular member to maintain the expandable member in a desired state of expansion.

2. The method of claim 1, wherein the expandable member is an inflatable balloon.

3. The method of claim 2, comprising inflating the balloon.

4. The method of claim 3, further comprising varying the relative position of the tubular member and the elongate member such that a port in a proximal section of the tubular member is exposed to fluid communication with the lumen of the tubular member to inflate the balloon.

5. The method of claim 1, wherein the expandable member is an occlusive device.

6. The method of claim 1, wherein the catheter is a guidewire, and further comprising advancing a second catheter over the guidewire.

7. The method of claim 1, wherein bends in the elongate member are frictionally engaged with an interior surface of the tubular member to maintain the expandable member in both an expanded configuration and a nonexpanded configuration.

8. A method, comprising:

providing an emboli protection catheter having an expandable member mounted on a tubular member, the tubular member having a lumen in which an elongate member is disposed;

inserting the catheter into a blood vessel;

varying the relative position of the tubular member and the elongate member, while at least a portion of the elongate member remains within the tubular member, to enable the expansion of the expandable member; and

maintaining the expandable member in an expanded state to prevent migration of emboli, while exchanging a plurality of treatment catheters over the tubular member of the emboli protection catheter.

9. The method of claim 8, wherein the expandable member is maintained in its expanded state by maintaining the position of the elongate member with respect to the tubular member.

10. The method of claim 9, wherein the position of the elongate member with respect to the tubular member is maintained by frictional contact.

11. The method of claim 10, wherein the frictional contact is provided by bends in the elongate member.

12. The method of claim 10, wherein the tubular member and the elongate member maintain frictional contact while varying the relative position of the tubular member and the elongate member.

13. The method of claim 8, wherein the expandable member is an inflatable balloon.

14. The method of claim 13, comprising inflating the balloon.

15. The method of claim 8, comprising performing an angioplasty treatment procedure.

16. The method of claim 8, wherein the expandable member is an occlusive device.

17. A method of emboli protection in a blood vessel, comprising:

being providing a tube with an expandable member thereon, the expandable member being expandable between a nonexpanded state, which permits delivery of the expandable member through the vessel, and an expanded state in which the expandable member prevents migration of emboli;

providing an elongate member, the elongate member being at least partially disposed within the tube when the expandable member is in its expanded state and also when the expandable member is in its nonexpanded state;

positioning the expandable member within the vessel in the nonexpanded state;

actuating the expandable member so that the expandable member expands to its expanded state to prevent migration of emboli in the vessel; and

maintaining the expandable member in its expanded state by maintaining the position of the tube relative to the elongate member;

wherein the expandable member is maintained in at least one of the nonexpanded and expanded states through frictional contact between a proximal section of the elongate member and the tube.

18. The method of claim 17, said actuating the expandable member comprising moving the tube to permit the flow of inflation fluid into the expandable member to expand the expandable member into its expanded state.

19. The method of claim 18, wherein the expandable member is a balloon.

20. The method of claim 17, wherein frictional contact is provided through bends in the elongate member which contact an interior surface of the tube.

21. The method of claim 17, wherein both the nonexpanded and expanded states of the elongate member are maintained through frictional contact between the elongate member and the tube.

22. A method, comprising:

providing a catheter comprising an expandable member and a tubular member, the expandable member connected to the tubular member, the tubular member comprising a lumen having an elongate member therein, the elongate member having a proximal end portion and a distal end portion;

inserting the catheter into a blood vessel;

varying the relative position of the tubular member and the elongate member, while at least a portion of the elongate member remains within the tubular member, to enable the expansion of the expandable member; and

frictionally contacting at least a portion of the proximal end portion of the elongate member with an interior surface of the tubular member to maintain the expandable member in a desired state of expansion.

23. The method of claim 22, in which the expandable member is a balloon.

24. The method of claim 23, comprising flowing inflation fluid into the balloon.

25. The method of claim 22, comprising expanding the expandable member until the expandable member contacts the vessel.

26. The method of claim 22, the elongate member having bends therein which frictionally engage the interior surface of the tubular member.

27. The method of claim 22, in which the desired state of expansion of the expandable member includes an unexpanded state.

28. The method of claim 22, in which the desired state of expansion of the expandable member includes an expanded state which prevents the migration of emboli.

29. A method, comprising:

providing a catheter comprising an expandable member and a tubular member, wherein the expandable member is connected to the tubular member, and the tubular member comprises a proximal section, a distal section, and a lumen for receiving an inner member therein, the inner member having a proximal end portion and a distal end portion;

inserting the catheter into a blood vessel;

expanding said expandable member; and

contacting at least a portion of the inner member with an interior surface of the tubular member in the proximal section of the tubular member to maintain the expandable member in a desired state of expansion.

30. The method of claim 29, wherein the expandable member is a balloon.

31. The method of claim 30, further comprising filling the lumen of the tubular member with an inflation media to inflate the balloon.

32. The method of claim 31, further comprising pressurizing the inflation media such that it flows through the lumen and expands the balloon on the distal end of the catheter.

33. The method of claim 29, wherein the catheter is a guidewire, and further comprising advancing a therapy catheter over the guidewire.

34. The method of claim 33, wherein the therapy catheter is introduced while the expandable member is expanded.

35. The method of claim 29, further comprising exchanging one therapy catheter for another over the catheter.

36. The method of claim 29, further comprising providing a sealing engagement between the inner member and the tubular member.

37. The method of claim 29, wherein the inner member moves in a proximal to distal direction relative to the tubular member prior to contacting at least a portion of the inner member with an interior surface of the tubular member in the proximal section of the tubular member to maintain the expandable member in a desired state of expansion.