Methods and apparatus for anchoring an occluding member

• US 20010001812A1
• Filed: 01/12/2001
• Published: 05/24/2001
• Est. Priority Date: 07/16/1991
• Status: Abandoned Application

• Current Assignee: Heartport, Inc. (Johnson & Johnson)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Snow, David W., Mueller, Richard L. Jr., Valley, Kirsten L., Fan, Sylvia W.
• Application Number:
  US09/759,431
• Publication Number:
  US 20010001812A1
• Time in Patent Office: Days
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/0161 : wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/028 : having a mainly rigid support structure
• CPC Class Codes: A61M 2025/1031 : Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1047 : having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1059 : having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
• CPC Class Codes: A61M 2025/1077 : having a system for expelling the air out of the balloon before inflation and use
• CPC Class Codes: A61M 2025/1095 : with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2202/047 : cardioplegic
• CPC Class Codes: A61M 2205/11 : with means for preventing cross-contamination when used for multiple patients
• CPC Class Codes: A61M 2205/366 : by liquid heat exchangers
• CPC Class Codes: A61M 2210/125 : Heart
• CPC Class Codes: A61M 2210/127 : Aorta
• CPC Class Codes: A61M 25/0028 : characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves catheter hubs A61M25/0097
• CPC Class Codes: A61M 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0041 : pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/0125 : Catheters carried by the bloodstream, e.g. with parachutes; Balloon catheters specially designed for this purpose
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0155 : with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 25/02 : Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/0662 : Guide tubes
• 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 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1006 : Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/1027 : Making of balloon catheters
• CPC Class Codes: A61M 25/1029 : Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1034 : Joining of shaft and balloon

Abstract

Pressure is measured on both sides of an occluding member for determining when pressure forces on the occluding member may cause migration of the occluding member. An alarm indicates when the pressure force on the balloon exceed a predetermined threshold. In another aspect of the invention, a pressure monitor determines when a rate of pressure increase with respect to the fluid volume in the balloon reaches a predetermined threshold when inflating the occluding member. A predetermined amount of fluid is then added to the balloon so that the balloon is not under inflated or over inflated.

Claims

1. A method of anchoring a balloon catheter in a patient, comprising the steps of:

providing a balloon catheter having a shaft and a balloon mounted to the shaft, the shaft having a distal end and a proximal end, the balloon having an expanded shape and a collapsed shape, the expanded shape being configured to occlude a body passageway in a patient, the balloon including an outer surface having at least two high friction portion and at least two low friction portions, the low friction portion having a lower coefficient of friction than the at least two high friction portions relative to the patient'"'"'s body passageway, the balloon having at least three radially extending arms when in the collapsed shape, each of the at least two low friction portions being positioned at radially outward extremes of adjacent radially extending arms, the high friction portion being exposed and positioned between the radially outward extremes of the adjacent radially extending arms when the balloon is in the collapsed shape, the high friction portion being everted when the balloon moves from the collapsed shape to the expanded shape;

positioning the balloon in the patient'"'"'s body passageway with the balloon in the collapsed shape so that the radially outward extremes contact the body passageway; and

advancing the balloon in the patient to a position to be occluded with the balloon in the collapsed shape;

inflating the balloon after the advancing step so that the high friction portion contacts the patient'"'"'s body passageway for anchoring the balloon in the patient'"'"'s body passageway.

2. The method of

claim 1

, wherein:

the positioning step is carried out by inserting the balloon into the patient'"'"'s arterial system; and

the inflating step is carried out with the balloon being positioned in the patient'"'"'s ascending aorta.

3. The method of

claim 1

, wherein:

the providing step is carried out with the balloon catheter having a first lumen and an opening at the distal end fluidly coupled to the first lumen, the opening being configured for delivery of a fluid into a patient.

4. The method of

claim 3

, further comprising the step of:

introducing cardioplegic fluid into the patient through the first lumen.

5. The method of

claim 1

, wherein:

the providing step is carried out with the balloon catheter having at least three arms extending radially outward from the shaft.

6. The method of

claim 1

, wherein:

the providing step is carried out with the high friction portion having a plurality of ribs.

7. The method of

claim 1

, wherein:

the providing step is carried out with the shaft having a substantially straight portion and a hooked portion connected to the substantially straight portion.

8. A balloon catheter for occluding a body passageway in a patient, comprising:

a shaft; and

a balloon mounted to the shaft, the balloon having an expanded shape and a collapsed shape, the expanded shape being configured to occlude a body passageway in a patient, the balloon including an outer surface having at least two high friction portions and a low friction portion, the low friction portion having a lower coefficient of friction than the high friction portions relative to the patient'"'"'s body passageway, the balloon having at least three radially extending arms when in the collapsed shape, each of the at least two low friction portions being positioned at radially outward extremes of adjacent radially extending arms, the high friction portion being exposed and being positioned between two of the radially outward extremes of the radially extending arms when the balloon is in the collapsed shape, the high friction portion being everted when the balloon moves from the collapsed shape to the expanded shape.

9. The balloon catheter of

claim 8

, wherein:

the balloon is configured and sized to occlude the patient'"'"'s ascending aorta.

10. The balloon catheter of

claim 8

, wherein:

the shaft includes a first lumen and an opening at the distal end fluidly coupled to the first lumen, the opening being configured for delivery of a fluid into a patient.

11. The balloon catheter of

claim 8

, further comprising:

a source of cardioplegic fluid fluidly coupled to the first lumen.

12. The balloon catheter of

claim 8

, wherein:

the high friction portion includes a plurality of ribs.

13. The balloon catheter of

claim 8

, wherein:

the shaft has a substantially straight portion and a hooked portion connected to the substantially straight portion.

14. A method for positioning a balloon in a passageway and occluding the passageway, comprising the steps of:

providing a catheter having a shaft and a balloon mounted thereto, the balloon having a collapsed shape and an expanded shape;

inserting the catheter into a body passageway of a patient with the balloon in the collapsed shape;

positioning the catheter in a portion of the body passageway for occluding the portion of the body passageway;

inflating the balloon with a fluid;

monitoring a rate of pressure increase in the balloon with respect to a fluid volume in the balloon; and

adding an amount of fluid after the rate of pressure increase in the balloon exceeds a predetermined threshold.

15. The method of

claim 14

, wherein:

the positioning step is carried out by positioning the balloon in the patient'"'"'s ascending aorta.

16. The method of

claim 14

, wherein:

the providing step is carried out with the catheter having a lumen fluidly coupled to the balloon, the catheter also having a pressure sensor and a pressure sensing alarm, the pressure sensing alarm indicating when the rate of pressure increase in the balloon exceeds the predetermined threshold.

17. The method of

claim 14

, wherein:

the adding step is carried out with the amount of fluid being a predetermined volume of fluid.

18. The method of

claim 14

, wherein:

the adding step is carried out by adding the amount of fluid to increase the pressure in the balloon a predetermined amount.

19. A device for pressurizing a balloon catheter, comprising:

a catheter having a shaft and a balloon mounted thereto, the balloon having a collapsed shape and an expanded shape, the collapsed shape being configured for advancement within a patient the catheter having a first lumen fluidly coupled to the balloon for inflating the balloon;

a fluid source coupled to the first lumen for inflating the balloon;

a pressure sensor configured to measure a pressure in an interior of the balloon; and

a pressure monitor coupled to the pressure sensor, the pressure monitor determining when a rate of pressure increase in the balloon with respect to an increase in fluid volume in the balloon exceeds a predetermined threshold.

20. The device of

claim 19

, further comprising:

means for adding a predetermined amount of fluid after the pressure monitor detects the rate of pressure increase exceeds the predetermined threshold.

21. The device of

claim 19

, further comprising:

means for increasing the pressure in the balloon a predetermined amount after the pressure monitor detects the rate of pressure increase exceeds the predetermined threshold.

22. A method of anchoring an occluding member in a patient, comprising the steps of:

inserting a catheter having an occluding member mounted thereto, the occluding member having a collapsed shape and an expanded shape;

positioning the occluding member in a body passageway in the patient;

expanding the occluding member to the expanded shape after the positioning step to thereby occlude the body passageway;

monitoring a pressure exerted on the occluding member on a distal side and a proximal side of the occluding member; and

determining a difference between the pressure on the distal and proximal sides of the occluding member.

23. The method of

claim 22

, further comprising the step of:

adjusting a pressure on at least one of the distal and proximal sides of the occluding member.

24. The method of

claim 22

, wherein:

the adjusting step is carried out by adjusting a pressure on the distal side of the occluding member.

25. The method of

claim 22

, wherein:

the inserting step is carried out with the occluding member being a balloon.

26. The method of

claim 22

, wherein:

the inserting step is carried out with the body passageway being an ascending aorta.

27. A catheter for occluding an ascending aorta in a patient, comprising:

a shaft having a distal end and a proximal end;

an occluding member mounted to the shaft, the occluding member having an expanded shape sized to occlude the patient'"'"'s ascending aorta;

a first pressure sensor positioned between the distal end and the occluding member for measuring a pressure on a first side of the occluding member; and

a second pressure sensor positioned between the proximal end and the occluding for measuring a pressure on a second side of the occluding member.

28. The catheter of

claim 27

, further comprising:

a pressure monitor coupled to the first and second pressure sensors, the pressure monitor determining a pressure difference between the first and second pressure sensors.

29. The catheter of

claim 28

, further comprising:

an alarm coupled to the pressure monitor for indicating when a pressure difference sensed by the first and second pressure sensors exceeds a predetermined threshold.

30. The catheter of

claim 27

, wherein:

the occluding member is a balloon; and

the shaft includes a first lumen, a second lumen and an opening at the distal end of the shaft fluidly coupled to the first lumen, the second lumen being fluidly coupled to the balloon for inflating the balloon.

31. The catheter of

claim 30

, further comprising:

means for adjusting the pressure on at least one of the first and second sides of the balloon when a pressure difference sensed by the first and second pressure sensors exceeds a predetermined threshold, the pressure adjusting means reducing the pressure difference to a value below the predetermined threshold.

32. The catheter of

claim 31

, wherein:

the pressure adjusting means is coupled to the first lumen for adjusting a fluid pressure exerted by fluid delivered into the ascending aorta through the first lumen.

33. A method of anchoring an occluding member in an ascending aorta of a patient, comprising the steps of:

inserting a catheter into a patient, the catheter including a shaft having an occluding member at a distal end, the occluding member having a collapsed shape and an expanded shape;

positioning the catheter in the patient'"'"'s ascending aorta;

expanding the occluding member to the expanded shape after the positioning step to thereby occlude the ascending aorta; and

displacing the shaft of the catheter a first amount after the expanding step so that a predetermined portion of the catheter contacts the patient'"'"'s aortic lumen for anchoring the occluding member in the ascending aorta.

34. The method of

claim 33

, wherein:

the displacing step is carried out bv withdrawing an amount of the catheter from the patient so that the predetermined portion of the catheter engages a radially inner portion of the patient'"'"'s ascending aorta.

35. The method of

claim 33

, further comprising the step of:

displacing the catheter a second amount in a direction opposite to the first amount so that a second predetermined portion of the shaft engages a radially outer wall of the patient'"'"'s ascending aorta.

36. The method of

claim 33

, further comprising the step of:

inserting the shaft through a delivery cannula, the delivery cannula having a shaft engaging mechanism and a shaft displacing mechanism;

the displacing step being performed with the shaft displacing mechanism of the delivery cannula.

37. A catheter having an expandable member for occluding an ascending aorta in a patient, comprising:

a shaft having a longitudinal axis, a distal end, a proximal end, a first lumen and an opening at the distal end in fluid communication with the opening, the opening being configured for delivery of a fluid into the patient'"'"'s ascending aorta;

an expandable member mounted near the distal end of the shaft, the expandable member having an expanded shape and a collapsed shape, the expanded shape being configured to occlude the patient'"'"'s ascending aorta; and

a delivery cannula, the shaft being movably coupled to the delivery cannula for movement in a direction parallel to the longitudinal axis in an inward direction and an outward direction;

the shaft having a first portion configured to contact the radially inner wall of the aortic lumen when the shaft is slidably displaced in the outward direction.

38. The catheter of

claim 37

, further comprising:

a shaft displacing mechanism coupled to the delivery cannula, the shaft displacing mechanism being configured to displace the shaft a predetermined amount in the outward direction so that the first portion engages the radially inner wall of the aortic lumen.

39. The catheter of

claim 37

, wherein:

the shaft includes a second portion configured to contact a radially outer wall of the aortic lumen when the shaft is slidably displaced in the inward direction.

40. The catheter of

claim 39

, wherein:

the shaft includes a third portion configured to contact the radially outer wall of the aortic lumen when the shaft is slidably displaced in the inward direction, the second portion being positioned between the first and second portions.

41. The catheter of

claim 37

, wherein:

the delivery cannula includes a lumen for introducing a fluid into the patient.

42. The catheter of

claim 37

, wherein:

the shaft includes a first bend and a second bend, the first portion being positioned between the first and second bends.

43. A method of anchoring an occluding member in a patient comprising the steps of:

inserting a catheter into a patient, the catheter having an occluding member mounted thereto;

positioning the occluding member at a desired location;

expanding the occluding member to occlude the desired location; and

clamping a portion of the passageway adjacent the desired location to prevent migration of the occluding member.

44. The method of

claim 43

, wherein:

the inserting step is carried out with the occluding member being a balloon.

45. The method of

claim 43

, wherein:

the clamping step is carried out by clamping the body passageway around the balloon thereby trapping the balloon.

46. The method of

claim 43

, wherein:

the inserting step is carried out with the balloon having an indentation; and

the clamping step is carried out with the clamp being positioned around the indentation.

47. A method of anchoring an occluding member in a patient'"'"'s ascending aorta comprising the steps of:

inserting an occluding member in the ascending aorta between the coronary ostia and the brachiocephalic artery;

expanding the occluding member in the patient after the inserting step;

positioning an anchor in the brachiocephalic artery, the anchor having a proximal end extending into the aorta, the anchor preventing migration of the occluding member beyond the brachiocephalic artery.

48. The method of

claim 47

, wherein:

the positioning step is carried out with the anchor being a perfusion catheter configured to deliver oxygenated blood to the brachiocephalic artery.

49. The method of

claim 47

, wherein:

the anchor is separate from the catheter.