Methods and apparatus for anchoring an occluding member

• US 5,795,325 A
• Filed: 12/11/1995
• Issued: 08/18/1998
• Est. Priority Date: 07/16/1991
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation), Xerox Corporation (Xerox Holdings Corp.)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Snow, David W., Mueller, Richard L. Jr., Valley, Kirsten L., Fan, Sylvia W.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/570,286
• Time in Patent Office: 981 Days
• Field of Search: 604/96, 604/97, 604/98, 604/100, 604/104, 604/49, 604/53, 606/192, 606/194
• US Class Current: 604/509
• 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 making of catheters A61M25/0009
• 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 with different compartments A61M2025/1072
• 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 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.

2. The method of claim 1, wherein:

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

3. The method of claim 1, wherein:

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

4. 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 wherein;

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

5. 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 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.

6. 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 coupled to the first lumen and being 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.

7. The device of claim 6, further comprising:

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

8. The device of claim 6, 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, the pressure increasing means being coupled to the first lumen.

9. A method of occluding a patient'"'"'s ascending aorta, comprising the steps of:

inserting a catheter having an occluding member mounted thereto, the occluding member having a collapsed shape and an expanded shape, the catheter having first means for sensing a pressure distal to the occluding member and second means for sensing a pressure proximal to the occluding member, the catheter also having a lumen with an outlet distal to the occluding member;

coupling the lumen of the catheter to a source of cardioplegic fluid;

positioning the occluding member in a patient'"'"'s ascending aorta;

expanding the occluding member to the expanded shape after the positioning step to thereby occlude the patient'"'"'s ascending aorta;

monitoring a pressure exerted on the occluding member on a distal side and a proximal side of the occluding member with the first and second pressure sensing means; and

infusing cardioplegic fluid into the patient'"'"'s ascending aorta thereby arresting the patient'"'"'s heart.

10. The method of claim 9, further comprising the step of:

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

11. The method of claim 10, wherein:

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

12. The method of claim 9, wherein:

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

13. 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 wherein;

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

14. 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;

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

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; and

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.

15. The catheter of claim 14, 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.

16. The catheter of claim 15, 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, the pressure adiusting means being coupled to at least one of the first and second lumens.

17. The catheter of claim 16, 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.