Transseptal cannula, tip, delivery system, and method

• US 9,022,916 B2
• Filed: 06/30/2014
• Issued: 05/05/2015
• 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, Dusbabek, Andrew J., Hudgins, Robert G.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US14/319,549
• Publication Number:
  US 20140336445A1
• Time in Patent Office: 309 Days
• Field of Search: 600/16, 600/17, 607/101, 607/115, 607/130
• 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 circulatory assist system, comprising:

a cannula assembly having distal and proximal ends and a lumen therebetween;

a pump for drawing blood into the cannula assembly and dispensing the blood from the cannula assembly and into the patient circulatory system; and

a delivery sheath for delivering the cannula assembly through the patient circulatory system, wherein the delivery sheath is configured to receive the cannula assembly and move relative thereto for deploying the cannula assembly adjacent a heart cavity and further comprises a distal end, a proximal end, and a body therebetween; and

a tensile element carried and extending along a length of the body, the tensile element configured to prevent deformation of the body when the cannula assembly moves relative to the delivery sheath.

2. The delivery system of claim 1, wherein the tensile element is configured to prevent plastic deformation of the delivery sheath in a substantially axial direction.

3. The delivery system of claim 1, wherein the delivery sheath further comprises an inner wall defining a passage for receiving the cannula assembly, and an outer wall, and the tensile element is disposed between the inner and outer walls of the delivery sheath.

4. The delivery system of claim 1, wherein the tensile element comprises at least one of the following:

a monofilament or polyfilament.

5. The delivery system of claim 4, wherein the tensile element further comprises at least one of the following:

metal, fabric, or polymer.

6. A circulatory assist system for assisting the flow of blood through a patient circulatory system, comprising:

a cannula assembly for directing blood from the heart of a patient, the cannula assembly comprising a flexible cannula body including a proximal end and a distal end and a lumen therebetween;

a pump for drawing blood from the heart into the cannula assembly and dispensing the blood from the cannula assembly and into the patient circulatory system, the pump further including an inlet and an outlet;

an outflow cannula configured to provide fluid communication between the outlet and the cardiovascular system of a patient; and

an adaptor device configured to fluidicly communicate the inlet and the cannula body, the adaptor device including a proximal end, a distal end, and a lumen therebetween;

wherein the distal end of the adaptor device is configured to couple with the proximal end of the cannula body and the proximal end of the adaptor device is configured to couple with the inlet of the pump;

wherein the adaptor device is configured such that blood flowing into the distal end of the adaptor device flows in a generally lateral direction relative to the patient and blood flowing out of the proximal end of the adaptor device and into the inlet flows in a generally medial direction relative to the patient.

7. The circulatory assist system of claim 6, wherein the lumen of the adaptor device includes a tapered portion between the proximal and distal ends, the tapered portion defined as a decrease in inner diameter from a first inner diameter to a second inner diameter between the proximal and distal ends, respectively.

8. The circulatory assist system of claim 7, wherein the decrease in inner diameter is constant along the tapered portion.

9. The circulatory assist system of claim 6, wherein the distal end of the adaptor device further comprises a fitting adapted to receive the proximal end of the cannula assembly.

10. A method of deploying a circulatory assist system into a circulatory system of a patient, the circulatory assist system including a cannula assembly and a pump, the assist system for assisting the flow of blood through the circulatory system, comprising:

directing a cannula assembly into the circulatory system of a patient, wherein a distal end of the cannula assembly extends into a chamber of the heart, and the proximal end of the cannula assembly extends in a generally lateral direction therefrom;

implanting a pump having an inlet and an outlet such that the inlet faces in a generally lateral direction relative to the patient;

fluidicly communicating the outlet of the pump with the circulatory system using an outflow cannula;

coupling a proximal end of the cannula assembly with a distal portion of an adaptor device;

coupling a proximal portion of the adaptor device with the inlet of the pump;

wherein the adaptor device is configured such that blood flowing into the distal end of the adaptor device flows in a generally lateral direction relative to the patient, and blood flowing out of the proximal end of the adaptor device and into the inlet flows in a generally medial direction relative to the patient.

11. The method of claim 10, wherein the circulatory system is an artery.

12. The method of claim 11, wherein the artery is a subclavian artery.