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

• US 20070197855A1
• Filed: 01/26/2007
• Published: 08/23/2007
• Est. Priority Date: 02/23/2006
• Status: Active Grant

• Current Assignee: Thoratec LLC
• Original Assignee: Levitronix LLC (George N. Hatsopoulos, PhD)
• Inventors: Gellman, Barry N., Dasse, Kurt, Richardson, J. Scott, Koert, Andrew
• Granted Patent: US 8,118,723 B2
• Time in Patent Office: Days
• 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. Said 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 said 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 said 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 a heart (2) and/or from an associated vessel to an external blood handling system, said pump-inflow-cannula comprising 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 said 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), characterized in that said body (3) of the pump-inflow-cannula comprises a reinforcement-means (8).

2. A pump-inflow-cannula in accordance with claim 1, comprising a reinforced body-portion (9) to be essentially contained within a corpus, especially to be contained within the corpus and extending beyond a skin of the corpus, and a compressible and/or bendable system-portion (10) to be located outside of the corpus.

3. A pump-inflow-cannula in accordance with claim 1, wherein the reinforcement-means (8) are located within a wall structure (11) of the body (3) of the pump-inflow-cannula.

4. A pump-inflow-cannula in accordance with claim 1, wherein the reinforcement means (8) is a wire (8), in particular a wire (8) made of plastic and/or made of a composite material and/or made of a metal, especially made of a stainless steel.

5. A pump-inflow-cannula in accordance with claim 1, wherein the reinforcement means (8) is a spring (8), in particular a helical spring (8), especially a flat spring (8) and in more particular a flat spring (8) being between 0.01″

and 0.03″

wide and being between 0.003″ and

0.007″

thick, in particular being 0.02″

wide×

0.005″

thick, preferably with a pitch ranging from 0.002″

to 0.040″ and

/or the reinforcement-means (8) is encapsulated in a polymer.

6. A pump-inflow-cannula in accordance with claim 1, wherein, a blood exposed surface (12) of the projection (7) provided at the proximal-end (6) is rounded to reduce blood trauma.

7. A pump-inflow-cannula in accordance with claim 1, wherein the projection (7) is spring reinforced by means of a tip-spring (13) 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 (4) and wherein an axial extension of the projection is between 0.25″

and 0.75″

, preferably 0.46° and

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

0.70″

, preferably 0.40″

, and/or wherein the tip-spring (13) is encased in the projection (7) to avoid a contact of the tip-spring (13) with blood.

8. A pump-inflow-cannula in accordance with claim 1, wherein at least two projections (7) are provided at the proximal-end (6) being separated by a tip-valley (14).

9. A pump-inflow-cannula in accordance with claim 1, wherein at the distal-end (5) of the inflow-lumen (4) a straight lumen (15) in particular a straight 7.2 mm lumen (15) is provided and/or a convertible distal end is provided comprising at the segment of the 7.2 mm lumen (15) a transition to a lumen (16), in particular to a ⅜

″

lumen (16) capable of receiving a ⅜

″

tube connector, in particular a barbed ⅜

″

tube connector.

10. A pump-inflow-cannula in accordance with claim 1, wherein a surface of the pump-inflow-cannula is biocompatible to blood and/or a tissue and/or the pump-inflow cannula is made of a polycarbonate-based urethane, especially made of carbothane and/or another urethane and/or PVC, and/or vinyl materials, and/or elastomeric materials, and the cannula material durometer ranges from 50 Shore A to 100 Shore A, preferably from 70 Shore A to 90 Shore A and/or the pump-inflow-cannula is fabricated by dip-molding, extrusion, injection molding or combinations thereof and/or is fabricated in a single polymer layer and/or in multiple polymer layers and/or in sections hermetically bonded.

11. A pump-inflow-cannula in accordance with claim 1, wherein a wrap (17) is provided on the surface of the body of the inflow-cannula, especially a wrap (17) of a polyester velour material, providing a means to enable tissue in-growth.

12. A pump-inflow-cannula in accordance with claim 1, wherein a depth-indicator (18) is provided for indicating a placement depth from the epicardial surface of the heart (2).

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 (6) of the pump-inflow-cannula for post-surgical placement assessment and wherein the radiopaque feature is a stainless steel marking-spring incorporated in the proximal end of the pump-inflow-cannula and/or the radiopaque feature is marker made of tantalum and/or stainless steel and/or an other radiopaque material.

14. A pump-inflow-cannula in accordance with claim 1, wherein the inflow-lumen (4) is a multi-inflow-lumen comprising at least two sub-lumens providing a passage-means for a passage of a secondary device, in particular for a passage of a diagnostic and/or a therapeutic tool, in more particular for a temperature sensing tool and/or a blood gas sensing tool and/or a pressure measuring tool and/or for a passage of a guidewire and/or a catheter and/or a passage for flushing and/or a passage for a vascular injection and or a on other passage-means.

26. A blood managing system comprising a pump-inflow-cannula (1) in accordance with claim 1 and a pump-outflow-cannula (19) in accordance with claim 15.

27. A blood managing system in accordance with claim 26, wherein a tunneler-plug (34) is provided to assist the pump-inflow-cannula (1) and/or the pump-outflow-cannula (19) in tunneling through a tissue of a corpus.

28. A blood managing system in accordance with claim 26, wherein, a sewing-ring (35) is provided to securely locate the pump-inflow-cannula (1) into a heart (2).

29. A blood managing system in accordance with claim 26, wherein a cannula-tip-stabilizer is provided to secure the pump-inflow-cannula (1) and/or the pump-outflow-cannula (19) to the heart (2) and/or to an associated vessel.

30. A blood managing system in accordance with claim 26, wherein a stabilizing-ring (36) is provided to secure the pump-inflow-cannula (1) and/or the pump-outflow-cannula (19) with a suture.

31. A blood managing system in accordance with claim 26, wherein an introducer is provided for the placement of the pump-inflow-cannula (1) and/or the pump-outflow-cannula (19) into the vessel.

32. A blood managing system in accordance with claim 26, wherein a blood handling system, in particular a blood pump, or an oxygenator, especially an extracorporeal membrane oxygenator, or a dialysis apparatus, or an other medical apparatus is provided for connection with the pump-inflow-cannula (1) and/or with the pump-outflow-cannula (19), in particular to connect the pump-inflow-cannula (1) with the pump-outflow-cannula (19).

15. A pump-outflow-cannula providing a blood conduit from an external blood handling system to a heart (2) and/or to an associated vessel, said pump-outflow-cannula comprising a body (20) encompassing an essentially axially extending outflow-lumen (21) having a distal-end (22) for an introduction of blood from said blood management system into the outflow-lumen (21), and having a proximal-end (23) for an attachment of the outflow-lumen (21) to the heart (2) and/or to the associated vessel, characterized in that said body (20) of the pump-outflow-cannula comprises a reinforcement-means (24).

16. A pump-outflow-cannula in accordance with claim 15, comprising a reinforced body-portion (25) to be essentially contained within a corpus of a human or an animal, especially to be contained within the corpus and extending beyond a skin of the corpus, and comprising a compressible and/or bendable system-portion (26) to be located outside of the corpus.

17. A pump-outflow-cannula in accordance with claim 15, wherein the reinforcement-means (24) are located within a wall structure (27) of the body (20) of the pump-outflow-cannula.

18. A pump-outflow-cannula in accordance with claim 15, wherein the reinforcement-means (24) is a wire (24), in particular a wire (24) made of plastic, and/or made of a composite material, and/or made of a metal, especially made of a stainless steel.

19. A pump-outflow-cannula in accordance with claim 15, wherein the reinforcement-means (24) is a spring (24), in particular a helical spring (24), especially a flat spring (24) and in more particular a flat spring (24) being between 0.01″

and 0.03″

wide and being between 0.003″ and

0.007″

thick, in particular being 0.02″

wide×

0.005″

thick, preferably with a pitch ranging from 0.002″

to 0.040″ and

/or the reinforcement-means (24) is encapsulated in a polymer.

20. A pump-outflow-cannula in accordance with claim 15, wherein at the distal end (22) of the outflow-lumen a straight lumen (28), in particular a straight 7.2 mm lumen (28) is provided and/or a convertible distal end is provided comprising at the segment (28) a transition to a lumen (29), in particular to a ⅜

″

lumen (29) capable of receiving a ⅜

″

tube connector, in particular a barbed ⅜

″

tube connector.

21. A pump-outflow-cannula in accordance with claim 15, wherein the proximal-end (23) comprises a securing-means (30) for securing the proximal-end (23) to the heart (2) and/or to the associated vessel, in particular a vascular graft (30) and/or an embedded winding (30) for securing a vascular graft (30).

22. A pump-outflow-cannula in accordance with claim 15, wherein the proximal-end (23) comprises a fluid-deflection (31) for controlling the blood flow into a vessel, in particular a fluid-deflection (31) with hardened deflection-tip, wherein the deflection-tip is straight or bend 1°

to 60°

, preferably 5°

to 30°

from an longitudinal axis (32) of the outflow-lumen (21).

23. A pump-outflow-cannula in accordance with claim 15, wherein a surface of the pump-outflow-cannula is biocompatible to blood and/or a tissue and/or the pump-outflow cannula is made of a polycarbonate-based urethane, especially made of carbothane and/or another urethane and/or PVC, and/or vinyl materials, and/or elastomeric materials, and the cannula material durometer ranges from 50 Shore A to 100 Shore A, preferably from 70 Shore A to 90 Shore A and/or the pump-inflow-cannula is fabricated by dip-molding, extrusion, injection molding or combinations thereof and/or is fabricated in a single polymer layer and/or in multiple polymer layers and/or in sections hermetically bonded.

24. A pump-outflow-cannula in accordance with claim 15, wherein a wrap (33) is provided on the surface of the body (20) of the pump-outflow-cannula, especially a wrap (33) of a polyester velour material, providing a means to enable tissue in-growth.

25. A pump-outflow-cannula in accordance with claim 15, wherein a depth-indicator is provided for indicating a placement depth into the vessel.

33. A Method for connecting a pump-inflow-cannula (1) to a heart (2) and/or to an associated vessel of a human and/or an animal blood circulation comprising the following steps:

providing a pump-inflow-cannula (1) for establishing a blood conduit from the heart (2) and/or from an associated vessel to an external blood handling system, said pump-inflow-cannula (1) comprising 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 said blood management 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), and said body (3) of the pump-inflow-cannula (1) comprises a reinforcement-means (8).

fixing the proximal-end (6) of the pump-inflow-cannula (1) at the heart (2) and/or at the associated vessel, in particular fixing the pump-inflow-cannula (1) by a sewing technique.

35. Method for connecting a blood managing system to a heart (2) and/or to an associated vessel of a human and/or an animal blood circulation comprising the following steps:

connecting a pump-inflow-cannula (1) to a heart (2) and/or to an associated vessel in accordance with claim 33 and/or connecting a pump-outflow-cannula (19) to a heart (2) and/or to an associated vessel in accordance with claim 34;

connecting a pump-outflow-cannula (19) to a heart (2) and/or to an associated vessel in accordance with claim 34 and/or connecting a pump-inflow-cannula (1) to a heart (2) and/or to an associated vessel in accordance with claim 33.

36. Method for connecting a blood managing system in accordance with claim 35, providing a blood handling system, in particular a blood pump, or an oxygenator, especially an extracorporeal membrane oxygenator, or a dialysis apparatus, or an other medical apparatus and connecting said blood handling system with the distal-end (5) of the pump-inflow-cannula (1) and/or with the distal-end (22) of the pump-outflow-cannula (19).

34. A Method for connecting a pump-outflow-cannula (19) to a heart (2) and/or to an associated vessel of a human and/or an animal blood circulation comprising the following steps:

providing a pump-outflow-cannula (19) for establishing a blood conduit from an external blood handling system to the heart (2) and/or to an associated vessel, said pump-outflow-cannula (19) comprising a body (20) encompassing an essentially axially extending outflow-lumen (21) having a distal-end (22) for an introduction of blood from said blood management system into the outflow-lumen (21), and having a proximal-end (23) for an attachment of the outflow-lumen (21) to the heart (2) and/or to the associated vessel, and said body (20) of the pump-outflow-cannula (19) comprises a reinforcement-means (24);

fixing the proximal-end (23) of the pump-outflow-cannula (19) at the heart (2) and/or at the associated vessel, in particular fixing the pump-outflow-cannula (19) by a sewing technique.

37. Method for performing a bypass of a human and/or of an animal organ, in particular for bypassing a heart (2), and/or for dialysis, and/or for a active suction or pump assisted autotransfusion, and/or for a cardio-pulmonary bypass surgery and or for performing a bypass within an other medical use, characterized in that

a pump-inflow-cannula (1) for establishing a blood conduit from a heart (2) and/or from an associated vessel to an external blood handling system is provided, said pump-inflow-cannula (1) comprising 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 said blood management 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), and said body (3) of the pump-inflow-cannula comprises a reinforcement-means (8);

and/or

a pump-outflow-cannula (19) for establishing a blood conduit from an external blood handling system to a heart (2) and/or to an associated vessel is provided, said pump-outflow-cannula (19) comprising a body (20) encompassing an essentially axially extending outflow-lumen (21) having a distal-end (22) for an introduction of blood from said blood management system into the outflow-lumen (21), and having a proximal-end (23) for an attachment of the outflow-lumen (21) to the heart (2) and/or to the associated vessel, and said body (20) of the pump-outflow-cannula (19) comprises a reinforcement-means (24);

and/or

a blood handling system, in particular a blood pump, or an oxygenator, especially an extracorporeal membrane oxygenator, or a dialysis apparatus, or an other medical apparatus is provided;

and/or

the proximal-end (6) of the pump-inflow-cannula (1) is fixed at the heart (2) and/or at the associated vessel, in particular the pump-inflow-cannula (1) is fixed by a sewing technique.

and/or

the proximal end of the pump-outflow-cannula (19) is fixed at the heart (2) and/or at the associated vessel, in particular the pump-outflow-cannula (19) is fixed by a sewing technique;

and/or

said blood handling system is connected with the distal-end (5) of the pump-inflow-cannula (1) and/or with the distal-end (22) of the pump-outflow-cannula (19).