Methods and apparatus for anchoring an occluding member

• US 6,251,093 B1
• Filed: 07/13/1998
• Issued: 06/26/2001
• Est. Priority Date: 07/16/1991
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Snow, David W., Mueller, Richard L. Jr., Valley, Kirsten L., Fan, Sylvia W.
• Primary Examiner(s): Kennedy, Sharon
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/114,307
• Time in Patent Office: 1,079 Days
• Field of Search: 604/96, 604/104, 604/264, 604/500, 604/506-509, 604/523, 606/192, 606/194
• US Class Current: 604/97.03
• 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 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 occluding member so that the balloon is not under inflated or over inflated.

Claims

1. 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 an opening at the distal end in fluid communication with the lumen, the opening being configured for delivery of a fluid into the patient'"'"'s ascending aorta, and a first portion configured to contact the radially inner wall of the aortic lumen when the shaft is slidably displaced in the outward direction;

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;

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; and

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.

2. The catheter of claim 1, 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.

3. The catheter of claim 2, 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.

4. The catheter of claim 1, wherein:

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

5. The catheter of claim 1, wherein:

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

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

inserting a catheter into a patient, the catheter including a balloon mounted thereto, the balloon having an indentation;

positioning the balloon at a desired location in a target vessel;

expanding the balloon to occlude the desired location; and

clamping a portion of the target vessel adjacent the desired location with a clamp to prevent migration of the occluding member;

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.

7. 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.

8. The method of claim 7, wherein:

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

9. The method of claim 7, wherein:

the anchor is separate from the catheter.