Methods and devices for occluding the ascending aorta and maintaining circulation of oxygenated blood in the patient when the patient's heart is arrested

• US 6,350,252 B2
• Filed: 07/09/1998
• Issued: 02/26/2002
• Est. Priority Date: 01/23/1998
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Malecki, William W., Komtebedde, Jan, Ray, Pinaki
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/112,514
• Publication Number:
  US 20010041858A1
• Time in Patent Office: 1,328 Days
• Field of Search: 604/96, 604/104-109, 606/191, 606/194, 606/198
• US Class Current: 604/107
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2210/127 Aorta
• 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

Abstract

A device and method for occluding a patient'"'"'s ascending aorta, maintaining circulation of oxygenated blood in the patient and delivering cardioplegic fluid to arrest the patient'"'"'s heart. An aortic occlusion device has an occluding member in the form of a non-inflatable structure which is moved mechanically between collapsed and expanded orientations. The device is introduced into the ascending aorta in its collapsed orientation and is moved to its expanded orientation to occlude the aorta. The aortic occlusion includes a lumen through which blood is delivered to the patient. The lumen may be provided in the aortic occlusion device or in a separate cannula coupled to the device.

Claims

1. A device for occluding a patient'"'"'s aorta, the device comprising:

a cannula having a lumen extending through at least a portion of the cannula;

a source of oxygenated blood coupled to the lumen which provides bypass support for the patient;

an occluding member provided on the cannula and movable between a collapsed orientation and an expanded orientation, the occluding member being sized and configured to occlude a patient'"'"'s aorta when in said expanded orientation;

wherein the occluding member comprises a non-inflatable structure which moves mechanically from one of said collapsed and expanded orientations to the other of said orientations, the non-inflatable structure having an exterior that is at least substantially impervious to fluid to prevent fluid flow through a patient'"'"'s aorta when the occluding member is positioned in the aorta in said expanded orientation, the occluding member being generally cylindrically-shaped when in said collapsed orientation and generally bell-shaped when in said expanded orientation;

wherein the non-inflatable structure includes a plurality of individual support elements which move relative to each other as the occluding member moves between said collapsed and expanded orientations; and

an actuator for moving the occluding member from one of said collapsed and expanded orientations to the other of said orientations;

wherein substantially the entire occluding member is disposed inside the lumen of the cannula when the occluding member is in said collapsed orientation, and substantially the entire occluding member is disposed outside of the lumen of the cannula when the occluding member is in said expanded orientation.

2. The device of claim 1, wherein the actuator comprises a shaft which is movable within the lumen of the cannula, and each of the individual support elements has a first portion secured to the cannula and a second portion secured to the shaft, whereby relative movement of the cannula and the shaft moves the occluding member between said collapsed and expanded orientations.

3. The device of claim 2, wherein the shaft is axially movable within the lumen of the cannula.

4. The device of claim 2, further comprising a handle including first and second relatively movable portions coupled, respectively, to the cannula and the shaft.

5. The device of claim 2, wherein an annular space is defined between the cannula and the shaft and blood may flow through the annular space into the patient'"'"'s aorta.

6. The device of claim 2, wherein the shaft has a lumen that communicates a portion of the device located proximal to the occluding member with a portion of the device located distal to the occluding member, and blood may flow through the lumen of the shaft into the patient'"'"'s aorta.

7. The device of claim 1, wherein the individual support elements are interwoven with each other to form an expandable braided structure.

8. The device of claim 7, wherein each of the individual support elements comprises a plurality of discreet filaments that are disposed generally parallel to each other.

9. The device of claim 7, wherein the individual support elements are coated with a fluid-impervious substance.

10. The device of claim 9, wherein the individual support elements are braided such that the exterior of the occluding member is substantially imperforate when the occluding member is in said collapsed orientation, and such that the exterior of the occluding member defines open areas when the occluding member is in said expanded orientation, the fluid impervious substance preventing fluid flow through the open areas when the occluding member is in said expanded orientation.

11. The device of claim 1, wherein the individual support elements have an integral coating of a fluid-impervious material.

12. The device of claim 1, wherein the fluid-impervious material is silicone.

13. The device of claim 1, wherein the occluding member is generally tubular and includes proximal and distal ends separated by a central portion, the cross-sectional dimensions of the proximal end, distal end and central portion being substantially equal when the occluding member is in said collapsed orientation, and the cross-sectional dimension of the central portion being greater than the cross-sectional dimensions of the proximal and distal ends when the occluding member is in said expanded orientation.

14. The device of claim 1, wherein the individual support elements overlap each other and are movable relative to each other in a circumferential direction with respect to a longitudinal axis of the cannula.

15. The device of claim 1, wherein the individual support elements are flexible struts which are straight when the occluding member is in said collapsed orientation and bowed when the occluding member is in said expanded orientation.

16. The device of claim 1, wherein the individual support elements are helical coils which are closer together when the occluding member is in said collapsed orientation than in said expanded orientation.

17. The device of claim 1, wherein the individual support elements are flexible cross-members secured to each other so as to define adjacent openings, wherein the cross-members flex as the occluding member moves between said collapsed and expanded orientations.

18. The device of claim 1, wherein the individual support elements are covered by a sheath of a fluid-impervious material.

19. The device of claim 18, wherein the fluid-impervious material is silicone.