Method and apparatus for in vivo heart valve decalcification

• US 5,443,446 A
• Filed: 02/03/1994
• Issued: 08/22/1995
• Est. Priority Date: 04/04/1991
• Status: Expired due to Term

• Current Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Shturman Cardiology Systems, Inc.
• Inventors: Shturman, Leonid
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): STRIGHT, RONALD K
• Application Number:
  US08/190,990
• Time in Patent Office: 565 Days
• Field of Search: 604/28, 604/49, 604/52, 604/53, 604/96, 606/191-194, 606/159, 128/898
• US Class Current: 604/540
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/38 : Blood oxygenation
• CPC Class Codes: A61M 60/414 : transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/861 : Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/865 : Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: A61M 60/888 : Blood filters
• CPC Class Codes: A61M 60/896 : having flexible or resilient parts, e.g. flap valves

Abstract

A method and apparatus for in vivo removal of calcified deposits from an aortic valve. The apparatus includes an anchoring balloon catheter fixatable across the aortic valve, a tool for removing the deposits, and a mechanism means for securing the tool with respect to the anchoring balloon and the aortic valve. The method involves advancing an anchoring balloon catheter through the aorta and positioning it across the aortic valve, inflating the anchoring balloon to fixate it with respect to the aorta and aortic valve, and then operating a deposit removal tool secured to the anchoring balloon to remove the deposits.

Claims

1. A method of removing deposits from an aortic heart valve having a superior surface, comprising;

advancing through the aorta an anchoring balloon and a deposit removal tool movably connected with respect to an exterior surface of the anchoring balloon;

positioning the anchoring balloon across the aortic valve and positioning the deposit removal tool near the superior surface of the aortic valve;

inflating the anchoring balloon sufficiently to fixate it with respect to the aorta and aortic valve without completely collapsing the aortic valve; and

operating the deposit removal tool to remove the deposits.

2. The method of claim 1 wherein the anchoring balloon catheter includes a proximally extending lumen, the method including the steps of withdrawing blood through the lumen of the anchoring balloon catheter, optionally utilizing a pump, optionally oxygenating such blood, and then returning such blood to an artery.

3. The method of claim 2 wherein the anchoring balloon lumen includes an opening adjacent to the deposit removal tool, the blood withdrawing step comprising withdrawing blood adjacent the deposit removal tool.

4. The method of claim 3 further comprising filtering such blood and returning it to an artery.

5. The method of claim 1 further comprising the step of imaging the area adjacent the anchoring balloon.

6. The method of claim 5 wherein the imaging step comprises radiographic imaging.

7. The method of claim 5 wherein the imaging step includes imaging with ultrasound utilizing an ultrasound transducer carried by the anchoring balloon.

8. The method of claim 1 wherein the step of advancing the deposit removal tool through the aorta is performed after the anchoring balloon has been inflated.

9. The method of claim 8 wherein the step of advancing the deposit removal tool comprises advancing the tool through a catheter that has its distal end secured with respect to exterior surface of the anchoring balloon.

10. The method of claim 1 wherein the step of advancing the anchoring balloon includes the step of simultaneously advancing the deposit removal tool and the anchoring balloon through the aorta.

11. The method of claim 1 further comprising the steps of advancing a blood removal catheter through the vena cava to the right atrium and through the atrial septum to the left atrium and into the left ventricle, and then removing blood from the left ventricle through such catheter and returning such blood to an artery while the anchoring balloon is positioned across the aortic valve.

12. The method of claim 1 further comprising the steps of providing cardiopulmonary bypass support by inserting a vein access catheter into an artery, withdrawing blood through the vein access catheter, oxygenating the blood and returning it to the artery through an artery access catheter.

13. A method of removing deposits from the aortic valve of a heart, comprising;

advancing a deflated, furled anchoring balloon through the aorta and positioning it across the aortic valve, the anchoring balloon including a collapsible guiding catheter sheath;

inflating the anchoring balloon sufficiently to fixate it with respect to the aorta and aortic valve without completely collapsing the aortic valve;

advancing a guiding catheter and a deposit removal tool through the guiding catheter sheath after the anchoring balloon has been inflated and positioning the deposit removal tool near the superior surface of the aortic valve; and

operating the deposit removal tool to remove the deposits.

14. The method of claim 13 further comprising withdrawing blood from the left ventricle of the heart through a catheter, and returning such blood to the aorta.