Transseptal cannula, tip, delivery system, and method

• US 8,784,291 B2
• Filed: 06/27/2013
• Issued: 07/22/2014
• Est. Priority Date: 10/24/2007
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Farnan, Robert C., Olson, Scott A., Jung, Elizabeth, Hudgins, Robert G., Dusbabeck, Andrew J.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US13/928,717
• Publication Number:
  US 20130281760A1
• Time in Patent Office: 390 Days
• Field of Search: 600/16, 600/17, 607/115, 607/130, 604/264
• US Class Current: 600/16
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• 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 1/3666 Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
• CPC Class Codes: A61M 1/3667 with assisted venous return
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• 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 60/165 implantable in, on, or around the heart
• CPC Class Codes: A61M 60/508 Electronic control means, e.g. for feedback regulation
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• 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

Abstract

A cannula assembly, further comprising a cannula body for directing blood from the heart of a patient, having distal and proximal ends and a lumen therebetween. A tip coupled to the distal end of the body, the tip having an opening. A pump for drawing blood into the cannula assembly and dispensing the blood from the cannula assembly and into the patient circulatory system. The lumen of the cannula body further comprises a first inner diameter at the proximal end and a second inner diameter at the distal end, the first inner diameter being larger than the second inner diameter. A tapered portion defined as a decrease in inner diameter from the first inner diameter to the second inner diameter between the proximal and distal ends, the tapered portion configured to prevent cavitation of the blood within the cannula.

Claims

1. A method of implanting a circulatory assist system for assisting a flow of blood through a patient circulatory system, the circulatory assist system comprising a cannula assembly for directing blood from a heart of a patient, the cannula assembly comprising a flexible cannula body including a proximal portion and a distal portion and a lumen therebetween, a tip coupled with the distal portion of the flexible cannula body, and first and second anchors coupled with the tip and each of the first and second anchors being configured to be deployed from a contracted state to an expanded state, wherein the first and second anchors are configured to engage opposite sides of a heart tissue in the expanded state;

the method comprising;

directing a guide-element into a left atrium;

inserting a delivery system including the cannula assembly over the guide-element and into the left atrium, wherein the delivery system includes a delivery sheath configured to receive the flexible cannula body for movement relative thereto;

moving the cannula assembly relative to the delivery sheath so as to deploy the first anchor from the contracted state into the expanded state thereby engaging the heart tissue; and

retracting the delivery sheath so as to deploy the second anchor from the contracted state into the expanded state and thereby engaging the heart tissue.

2. The method of claim 1 further comprising:

directing the guide-element into the left atrium without puncturing the pericardium or myocardial wall.

3. The method of claim 1 further comprising:

creating an incision near a superficial vein and directing the guide-element from the incision to the left atrium through the intra-atrial septum.

4. The method of claim 1 further comprising:

attaching a pump to the cannula assembly, wherein the pump is configured to pump blood into the cannula assembly and direct the blood from the cannula assembly and into the patient circulatory system.

5. The method of claim 4, further comprising:

operatively connecting a controller to the pump.

6. The method of claim 5 further comprising:

implanting the pump subcutaneously or submuscularly at an incision site near a superficial vein.

7. The method of claim 1, wherein the heart tissue is the intra-atrial septum.

8. The method of claim 7 further comprising:

dilating an opening in the septum with an obturator directed over the guide-element.

9. The method of claim 1 further comprising:

dilating an opening in the septum between the left atrium and the right atrium with a balloon catheter.

10. A method of accessing a heart of a patient with an anchoring guide-element, wherein the anchoring guide-element includes an elongate main body having a lengthwise central axis, and an anchoring portion on a distal end, and the method comprising:

creating a first incision near a superficial vein;

inserting the anchoring guide-element through the first incision into the heart, and through a wall of the heart; and

deploying the anchoring portion from a contracted state to an expanded state, wherein the anchoring portion in the expanded state extends transverse to the lengthwise central axis and resists retraction through the wall of the heart.

11. The method of claim 10, wherein the wall of the heart is the septum.

12. The method of claim 10, wherein inserting the anchoring guide-element further comprises directing the anchoring guide-element through the wall of the heart without puncturing the pericardium or myocardial wall.

13. The method of claim 10 further comprising:

creating a second incision; and

directing a capture device through the second incision to the first incision, the capture device operable to redirect the main body of the anchoring guide-element from the first incision to the second incision.

14. A method of accessing a heart of a patient, the method comprising:

inserting an anchoring guide-element through a first incision located near a superficial vein, the anchoring guide-element including an elongate body portion having a lengthwise central axis, and an anchoring portion on a distal end of the body portion;

directing the anchoring guide-element from the first incision into the heart;

deploying the anchoring portion from a contracted state to an expanded state that is transverse to the lengthwise central axis and thereby resisting retraction from the heart;

inserting a capture device through a second incision located near a superficial vein;

capturing the body portion of the anchoring guide-element with the capture device; and

redirecting the body portion of the anchoring guide-element from the first incision to the second incision.

15. The method of claim 14 further comprising:

directing the anchoring guide-element into the heart without puncturing the pericardium or myocardial wall.

16. A method of crossing a tissue barrier, the method comprising:

creating an opening within the tissue barrier;

directing a balloon catheter to a first side of the tissue barrier at the opening, the balloon catheter including a balloon having a distal-cone portion;

inflating the balloon while on the first side of the tissue barrier;

advancing the balloon catheter to a second side of the tissue barrier through the opening such that the distal-cone portion pierces and dilates the opening; and

continuing to advance the balloon catheter until the balloon catheter extends through the opening and within the tissue barrier.