Pump-inflow-cannula, a pump-outflow-cannula and a blood managing system

• US 8,118,723 B2
• Filed: 01/26/2007
• Issued: 02/21/2012
• Est. Priority Date: 02/23/2006
• Status: Active Grant

• Current Assignee: Thoratec LLC
• Original Assignee: Thoratec LLC
• Inventors: Richardson, J. Scott, Gellman, Barry N., Koert, Andrew, Dasse, Kurt
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Bays, Pamela M
• Application Number:
  US11/698,322
• Publication Number:
  US 20070197855A1
• Time in Patent Office: 1,852 Days
• Field of Search: 600/16, 600/17, 604/264, 604/523, 604/543, 604/914
• US Class Current: 600/16
• 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 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• 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 60/232 Centrifugal pumps
• CPC Class Codes: A61M 60/37 Haemodialysis, haemofiltration or diafiltration
• CPC Class Codes: A61M 60/38 Blood oxygenation
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

The invention relates to a pump-inflow-cannula (1) providing a blood conduit from a heart (2) and/or from an associated vessel to an external blood handling system. The pump-inflow-cannula comprises a body (3), encompassing an essentially axially extending inflow-lumen (4), having a distal-end (5) for an attachment of the inflow-lumen (4) to the blood handling system, and having a proximal-end (6) for an introduction of blood from the heart (2) and/or from the associated vessel into the inflow-lumen (4), wherein at least one projection (7) is provided at the proximal-end (6) to deflect a heart muscle from intruding into the inflow-lumen (4), wherein the body (3) of the pump-inflow-cannula comprises a reinforcement-means (8). The invention is also related to a pump-outflow-cannula (19) and to a blood managing system comprising a pump-inflow-cannula and a pump-outflow-cannula in accordance with the present invention.

Claims

1. A pump-inflow-cannula providing a blood conduit from at least one of a heart or from an associated vessel to an external blood handling system, said pump-inflow-cannula comprising a body, encompassing a substantially axially extending inflow-lumen having a peripheral portion, a distal end for an attachment of the inflow-lumen to said blood handling system and a proximal-end for an introduction of blood from the heart and/or from the associated vessel into the inflow-lumen, at least two spaced-apart projections arranged at the proximal-end for preventing a heart muscle from intruding into the inflow-lumen and terminating in respective free ends of the projections, and a tip-spring engaging the at least two projections to resist flapping during blood passage and/or to provide additional resistance from inward deflection of the heart muscle from intruding into the inflow-lumen, the tip-spring being defined by first and second arcuate spring base segments which are opposite to each other, and embedded in the peripheral portion of the inflow lumen, and first and second, spaced-apart spring arms extending from the spring base segments along the respective projections to a location proximate to and short of the respective free ends of the projections, each spring arm extending from a respective end of one of the first and second spring base segments to a proximate end of the other spring base segment and including a pair of elongated, spaced-apart spring arm portions that extend from the respective ends of the arcuate spring base segments toward ends of the respective projections where the spaced-apart spring arm portions are joined to each other, the spring arms being embedded in the respective projections.

2. A pump-inflow-cannula in accordance with claim 1, comprising a reinforced body-portion substantially contained within a corpus having a skin and extending beyond a skin of the corpus, and at least one of a compressible or bendable system-portion to be located outside of the corpus.

3. A pump-inflow-cannula in accordance with claim 1, including reinforcement means located within a wall structure of the body of the pump-inflow-cannula.

4. A pump-inflow-cannula in accordance with claim 3, wherein the reinforcement means is a wire made of at least one of plastic, a composite material or a metal comprising stainless steel.

5. A pump-inflow-cannula in accordance with claim 3, wherein the reinforcement means comprises a helical spring.

6. A pump-inflow-cannula in accordance with claim 5 wherein the helical spring comprises a flat spring being between 0.01″

and 0.03″

wide and being between 0.003″ and

0.007″

thick.

7. A pump-inflow-cannula in accordance with claim 1, wherein a blood exposed surface of the at least two projections is rounded to reduce blood trauma.

8. A pump-inflow-cannula in accordance with claim 1, wherein the at least two projections are separated by a tip-valley.

9. A pump-inflow-cannula in accordance with claim 1, wherein at the distal end of the inflow-lumen a straight 7.2 mm lumen or a convertible distal end is provided comprising at the 7.2 mm lumen a transition to a ⅜

″

lumen capable of receiving one of a ⅜

″

tube connector or a barbed ⅜

″

tube connector.

10. A pump-inflow-cannula in accordance with claim 1, wherein a surface of the pump-inflow-cannula is at least one of biocompatible to blood or a tissue, and wherein the pump-inflow cannula is made of at least one of a polycarbonate-based urethane, carbothane, another urethane, PVC, vinyl materials or elastomeric materials, and wherein the cannula material durometer ranges from 50 Shore A to 100 Shore A or the pump-inflow-cannula is at least one of fabricated by dip-molding, extrusion, injection molding or combinations thereof or is fabricated as at least one of a single polymer layer, multiple polymer layers or sections that are hermetically bonded.

11. A pump-inflow-cannula in accordance with claim 1, wherein a wrap of a polyester velour material is provided on the surface of the body of the inflow-cannula which enables tissue in-growth.

12. A pump-inflow-cannula in accordance with claim 1, wherein a depth-indicator is provided for indicating a placement depth from the epicardial surface of the heart.

13. A pump-inflow-cannula in accordance with claim 1, wherein a radiopaque feature is provided comprising a reference feature to enable imaging of the proximal-end of the pump-inflow-cannula for post-surgical placement assessment and wherein the radiopaque feature is at least one of a stainless steel marking-spring incorporated in the proximal end of the pump-inflow-cannula, a marker made of tantalum or stainless steel.

14. A pump-inflow-cannula in accordance with claim 1, wherein the inflow-lumen is a multi-inflow-lumen comprising at least two sub-lumens providing a passage for a secondary device and wherein the secondary device comprises at least one of a diagnostic tool, a therapeutic tool, a temperature sensing tool, a blood gas sensing tool, a pressure measuring tool, a guidewire, a catheter, a passage for flushing or a passage for a vascular injection.

15. A pump-inflow-cannula in accordance with claim 1 wherein the at least two projections extend substantially parallel to each other in a generally axial direction of the cannula at the proximal-end thereof.

16. A pump-inflow-cannula in accordance with claim 1 wherein the body has a wall thickness, and wherein the at least two projections are defined by continuations of the wall thickness of the body.

17. A pump-inflow-cannula in accordance with claim 1 wherein an axial extension of the projection is between 0.25″

and 0.75″ and

the tip-spring has an axial extension between 0.15″ and

0.70″

.