COAXIAL BALLOON DELIVERY DEVICE AND METHOD OF DELIVERING A TRANSSEPTAL CANNULA TO A HEART

• US 20130231521A1
• Filed: 05/07/2013
• Published: 09/05/2013
• Est. Priority Date: 03/27/2009
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Farnan, Robert C.
• Granted Patent: US 9,028,393 B2
• Time in Patent Office: Days
• US Class Current: 600/16
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202
• 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

Abstract

A transseptal cannula having a flexible cannula body, a left atrial anchor coupled to the distal end of the flexible cannula body, and a right atrial anchor operable to be attached to the left atrial anchor in vivo. The left and right atrial anchors are implanted and deployed separately. Delivery of the transseptal cannula to a heart tissue can include a low profile coaxial balloon catheter comprising a tube body including an inner member and an outer member surrounding the inner member and thereby creating an inflation channel between the inner and outer members, a hub coupled to the proximal portion of the tube body and including a fluid space in fluid communication with the inflation channel; and a balloon coupled to the distal portion of the tube body, wherein the balloon is in fluid communication with the inflation channel. The hub of the coaxial balloon catheter is constructed with a low profile so that other surgical devices can be directed over the coaxial hub without deflating and removing the balloon.

Claims

1. A coaxial balloon catheter comprising:

a tube body including an inner member and an outer member surrounding the inner member and thereby creating an inflation channel between the inner and outer members;

a coaxial hub coupled to a proximal portion of the tube body and including a fluid space in fluid communication with the inflation channel, the coaxial hub having a low profile so that a surgical device can be loaded over the coaxial hub; and

a balloon coupled to a distal portion of the tube body, wherein a distal portion of the inner member extends through the balloon thereby creating an annular cavity between a wall of the balloon and the inner member.

2. The coaxial balloon catheter of claim 1, wherein the inner member within the balloon further includes a radiopaque marker.

3. The coaxial balloon catheter of claim 1, wherein the balloon further includes a distal cone structure operable to dilate an opening within a heart tissue.

4. The coaxial balloon catheter of claim 1, wherein the coaxial hub further includes a hub-body coupled to a hub-cap and enclosing a grommet.

5. The coaxial balloon catheter of claim 4, wherein the grommet is operable to retain an inflation fluid within the annular cavity of the balloon.

6. The coaxial balloon catheter of claim 4, wherein the grommet permits a rigid element to enter the inflation channel.

7. The coaxial balloon catheter of claim 6, wherein the rigid element is a needle or a sytlet.

8. The coaxial balloon catheter of claim 4, wherein the coaxial hub further includes a plurality of spokes.

9. The coaxial balloon catheter of claim 8, wherein the plurality of spokes is operable to couple the inner member to the coaxial hub.

10. The coaxial balloon catheter of claim 8, wherein the plurality of spokes is operable to provide a positive stop for the grommet.

11. The coaxial balloon catheter of claim 4, wherein the hub-cap further includes a grommet retention feature operable to prevent migration of the grommet.

12. A method of delivering a transseptal cannula assembly to a heart tissue, the transseptal cannula assembly comprising a flexible cannula body having distal and proximal ends with a lumen extending therebetween, a left atrial anchor coupled to a distal end of the flexible cannula body, the left atrial anchor configured to be deployed from a contracted state to an expanded state, and a right atrial anchor attachable to the left atrial anchor in vivo, and configured to be deployed from a contracted state to an expanded state, the method comprising:

implanting the flexible cannula body with the left atrial anchor in engagement with the heart tissue;

advancing the right atrial anchor in vivo to the left atrial anchor;

coupling the right atrial anchor to the left atrial anchor in vivo; and

deploying the right atrial anchor into engagement with the heart tissue to secure the heart tissue between the left and right atrial anchors.

13. The method according to claim 12, wherein implanting the left atrial anchor further comprises:

advancing the left atrial anchor to the heart tissue; and

deploying the left atrial anchor from the contracted state to the expanded state to engage the heart tissue.

14. The method according to claim 13, wherein deploying the left atrial anchor includes moving a sheath relative to the left atrial anchor, the sheath configured to receive the flexible cannula body and the left atrial anchor and move relative thereto for deploying the left atrial anchor into the expanded state.

15. The method according to claim 12, wherein advancing the right atrial anchor further comprises:

coupling the right atrial anchor to a right anchor delivery apparatus, wherein the right anchor delivery apparatus is received by a right anchor sheath, the right anchor sheath configured to receive the right anchor delivery apparatus and move relative thereto for deploying the right atrial anchor into the expanded state; and

advancing the right atrial anchor with the right anchor delivery apparatus and the right anchor sheath coaxially over the flexible cannula body and to the left atrial anchor.

16. The method according to claim 12, wherein the coupling of the right atrial anchor to the left atrial anchor includes creating a compression fit between a locking member of the right atrial anchor and the left atrial anchor.

17. The method according claim 12, further comprising:

advancing a guidewire to the heart tissue;

directing a coaxial balloon catheter over the guidewire to the heart tissue, the coaxial balloon catheter comprising a tube body including an inner member and an outer member surrounding the inner member, a coaxial hub coupled to a proximal portion of the tube body; and

a balloon coupled to a distal portion of the tube body;

inflating the balloon; and

advancing the balloon through the heart tissue, thereby dilating an opening through the heart tissue.

18. The method of claim 12 further comprising:

coupling the proximal end of the flexible cannula body to a circulatory assist device; and

pumping blood from the heart through the flexible cannula body with the circulatory assist device.