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

• US 20070197856A1
• Filed: 01/26/2007
• Published: 08/23/2007
• Est. Priority Date: 02/23/2006
• Status: Abandoned Application

• Current Assignee: Levitronix LLC (George N. Hatsopoulos, PhD)
• Original Assignee: Levitronix LLC (George N. Hatsopoulos, PhD)
• Inventors: Gellman, Barry N., Richardson, J. Scott, Marks, John D., Koert, Andrew
• Application Number:
  US11/699,163
• Publication Number:
  US 20070197856A1
• 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 2025/0076 Unidirectional valves
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2027/004 with at least a part of the circuit outside the body
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0075 Valve means
• 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

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 (1) comprising a body (3), encompassing an inflow-lumen (4), extending essentially axially along a center-line (5), having a distal-end (6) for an attachment of the inflow-lumen (4) to said blood handling system, and having a proximal-end (7) for an introduction of blood from the heart (2) and/or from the associated vessel into the inflow-lumen (4). At the proximal-end (7) at least one angled-hole (8), extending around a longitudinal hole-axis (9) is provided, and said hole-axis (9) includes a presettable hole-angle (α) with the center-line (5) of the inflow-lumen (4), wherein said body (3) of the pump-inflow-cannula (1) comprises a reinforcement-means (10). The invention is also related to a pump-outflow-cannula (23) and to a blood managing system comprising a pump-inflow-cannula (1) and a pump-outflow-cannula (23) 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 inflow-lumen (4), extending essentially axially along a center-line (5), having a distal-end (6) for an attachment of the inflow-lumen (4) to said blood handling system, and having a proximal-end (7) for an introduction of blood from the heart (2) and/or from the associated vessel into the inflow-lumen (4), wherein at the proximal-end (7) at least one angled-hole (8), extending around a longitudinal hole-axis (9), is provided, and said hole-axis (9) including a presettable hole-angle (a) with the center-line (5) of the inflow-lumen (4), characterized in that said body (3) of the pump-inflow-cannula comprises a reinforcement-means (10).

2. A pump-inflow-cannula in accordance with claim 1, comprising a reinforced body-portion (11) 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 (12) to be located outside of the corpus.

3. A pump-inflow-cannula in accordance with claim 1, wherein the reinforcement-means (10) are located within a wall-structure (13) of the body (3) of the pump-inflow-cannula.

4. A pump-inflow-cannula in accordance with claim 1, wherein the reinforcement means (10) is a wire (10), in particular a spring (10) 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, at least two angled-holes (8), in particular two to six angled-holes (8), preferably six angled-holes (8), more preferably four angled-holes (8) are provided and a shape of a boundary (14) of the angled-hole (8) is circular and/or elliptical and/or tear drop shaped, and/or triangular, and/or trapezoid and/or elsewise shaped.

6. A pump-inflow-cannula in accordance with claim 1, wherein the boundary (14) the angled-hole (8) is circularly shaped having a diameter (15) between 0.05″

and 0.20″

, preferably between 0.10″ and

0.15″

, more preferably 0.125″

, in particular 0.13″

.

7. A pump-inflow-cannula in accordance with claim 1, wherein the hole-angle (α

) included by the hole-axis (9) and the center-line (5) of the inflow-lumen (4) is between 0° and

90°

, preferably between 30° and

60°

.

8. A pump-inflow-cannula in accordance with claim 1, wherein at the proximal-end (7), preferably at the proximal-end (7) and distal to the angled-hole (8), an elongated-hole (16), in particular at least two elongated-holes (16), in more particular two to six elongated-holes (16), preferably six elongated-holes (16), more preferably four elongated-holes (16) are provided and the elongated-hole (16) is with respect to the center-line (5) preferably between 0.30″

and 0.50″

long, in particular 0.38″

long, and has a width between 0.05″ and

0.20″

, preferably between 0.10″ and

0.15″

, more preferably 0.125″

, in particular 0.13″

.

9. A pump-inflow-cannula in accordance with claim 1, wherein at a surface of the wall-structure (13) of the angled hole (8) and/or of the elongated-hole (16) an edge-radius (17, 171, 172) is provided to reduce trauma to the blood.

10. A pump-inlow-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 und/or PVC, and/or vinyl materials, and/or elastomeric materials, and the wall-structure (13) of the body (3) of the pump-inflow-cannula, in particular the proximal-end (7) of the pump-outflow-cannula, includes at least two layers (18), in particular including an inner soft-layer (181) having a hardness between 40 Shore A and 120 Shore A, preferably between 50 Shore A and 100 Shore A, in particular 70 Shore A and/or including an outer hard-layer (182) having a hardness between 40 Shore A and 120 Shore A, preferably between 50 Shore A and 100 Shore A, in particular 85 Shore A.

11. A pump-inflow-cannula in accordance with claim 1, wherein a depth-indicator (19) is provided for indicating a placement depth from the epicardial surface of the heart (2).

12. 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 (7) of the pump-inflow-cannula for post-surgical placement assessment and wherein the radiopaque feature is preferably a stainless steel marking-spring incorporated in the proximal-end (7) of the pump-inflow-cannula and/or radiopaque feature surrounding the inflow-lumen (4) and/or the radiopaque feature is a marker made of tantalum and/or stainless steel and/or an other radiopaque material.

13. A pump-inflow-cannula in accordance with claim 1, wherein a shaping-means (20), in particular a malleable wire (20) is provided to shape the proximal-end (7) of the pump-inflow-cannula.

14. A pump-inflow-cannula in accordance with claim 1, wherein a positionable securing-grommet (36) is provided to secure the pump-inflow-cannula.

15. A pump-inflow-cannula in accordance with claim 1, wherein at the distal-end (6) of the inflow-lumen (4) an inflow-fitting (21), in particular a barbed ⅜

″

fitting (21) capable of receiving a ⅜

″

tube-connector (22), preferably a fitting (21) comprising a countersink (211) to receive a fitting-wall (221) of the tube-connector (22), is provided for attachment of the pump-inflow-cannula to the external blood handling system.

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

28. A blood managing system in accordance with claim 27, wherein a tunneler-plug (38) is provided to assist the pump-inflow-cannula (1) and/or the pump-outflow-cannula (23) in tunnelling through a tissue of a corpus.

29. A blood managing system in accordance with claim 27, wherein, a sewing-ring (39) is provided to securely locate the pump-inflow-cannula (1) into a heart (2).

30. A blood managing system in accordance with claim 27, 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 (23), in particular to connect the pump-inflow-cannula (1) with the pump-outflow-cannula (23).

16. 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 (24) encompassing an essentially axially extending outflow-lumen (25) having a distal-end (26) for an introduction of blood from said blood management system into the outflow-lumen (25), and having a proximal-end (27) for an attachment of the outflow-lumen (25) to the heart (2) and/or to the associated vessel, characterized in that said body (24) of the pump-outflow-cannula comprises a reinforcement-means (28).

17. A pump-outflow-cannula in accordance with claim 16, comprising a reinforced body-portion (29) 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 (30) to be located outside of the corpus.

18. A pump-outflow-cannula in accordance with claim 16, wherein the reinforcement-means (28) are located within a wall structure (31) of the body (24) of the pump-outflow-cannula.

19. A pump-outflow-cannula in accordance with claim 16, wherein the reinforcement-means (28) is a wire (28), in particular a spring (28) made of plastic, and/or made of a composite material, and/or made of a metal, especially made of a stainless steel.

20. A pump-outflow-cannula in accordance with claim 16, wherein at the distal-end (26) of the outflow-lumen (25) an outflow-fitting (32), in particular a barbed ⅜

″

fitting (32) capable of receiving a ⅜

″

tube-connector (33), preferably a fitting (32) comprising a countersink (321) to receive a fitting-wall (331) of the tube-connector (33), is provided for attachment of the pump-outflow-cannula to the external blood handling system and/or wherein the distal-end (26) is straight or angled according to an distal-angle, the distal-angle preferably ranging from 0°

to 40°

from a outflow-lumen-axis (37), preferably ranging from 1°

to 30°

, in particular being 10°

.

21. A pump-outflow-cannula in accordance with claim 16, wherein the proximal-end (27) comprises a securing-means (34) for securing the proximal-end (27) to the heart (2) and/or to the associated vessel, in particular a vascular graft (34).

22. A pump-outflow-cannula in accordance with claim 16, wherein the proximal-end (27) of the outflow-lumen (25) is a through lumen comprising at a hardened proximal-tip (35), and the periphery about the proximal-tip (35) ranges from 0.005″

to 0.800″

, in particular from 0.100″

to 0.600″

, and is preferably 0.315″

.

23. A pump-outflow-cannula in accordance with claim 16, 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 und/or PVC, and/or vinyl materials, and/or elastomeric materials.

24. A pump-outflow-cannula in accordance with claim 16, wherein a depth-indicator is provided for indicating a placement depth into the vessel.

25. A pump-outflow-cannula in accordance with claim 16, wherein a positionable securing-grommet (36) is provided to secure the pump-outflow-cannula.

26. A pump-outflow-cannula in accordance with claim 16, wherein an introducer with a hub including a guide wire is provided, in particular a guide wire having a diameter of 0.038″

, to permit access into a vessel, in particular into the aorta.

31. 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 (6) for an attachment of the inflow-lumen (4) to said blood management system, and having a proximal-end (7) for an introduction of blood from the heart (2) and/or from the associated vessel into the inflow-lumen (4), wherein at the proximal-end (7) at least one angled-hole (8), extending around a longitudinal hole-axis (9), is provided, and said hole-axis (9) including a presetted hole-angle (α

) with the center-line (5) of the inflow-lumen (4), and said body (3) of the pump-inflow-cannula comprises a reinforcement-means (10).

fixing the proximal-end (7) 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.

33. 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 31 and/or connecting a pump-outflow-cannula (23) to a heart (2) and/or to an associated vessel in accordance with claim 32;

connecting a pump-outflow-cannula (23) to a heart (2) and/or to an associated vessel in accordance with claim 32 and/or connecting a pump-inflow-cannula (1) to a heart (2) and/or to an associated vessel in accordance with claim 31.

34. Method for connecting a blood managing system in accordance with claim 33, 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 (6) of the pump-inflow-cannula (1) and/or with the distal-end (26) of the pump-outflow-cannula (23).

32. Method for connecting a pump-outflow-cannula (23) 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 (23) 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 (23) comprising a body (24) encompassing an essentially axially extending outflow-lumen (25) having a distal-end (26) for an introduction of blood from said blood management system into the outflow-lumen (25), and having a proximal-end (27) for an attachment of the outflow-lumen (25) to the heart (2) and/or to the associated vessel, and said body (24) of the pump-outflow-cannula (23) comprises a reinforcement-means (28);

fixing the proximal-end (27) of the pump-outflow-cannula (24) at the heart (2) and/or at the associated vessel, in particular fixing the pump-outflow-cannula (23) by a sewing technique.

35. 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 (6) for an attachment of the inflow-lumen (4) to said blood management system, and having a proximal-end (7) for an introduction of blood from the heart (2) and/or from the associated vessel into the inflow-lumen (4), wherein at the proximal-end (7) at least one angled-hole (8), extending around a longitudinal hole-axis (9), is provided, and said hole-axis (9) including a presetted hole-angle (α

) with the center-line (5) of the inflow-lumen (4), and said body (3) of the pump-inflow-cannula comprises a reinforcement-means (10);

and/or

a pump-outflow-cannula (23) 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 (23) comprising a body (24) encompassing an essentially axially extending outflow-lumen (25) having a distal-end (26) for an introduction of blood from said blood management system into the outflow-lumen (25), and having a proximal-end (27) for an attachment of the outflow-lumen (25) to the heart (2) and/or to the associated vessel, and said body (24) of the pump-outflow-cannula (23) comprises a reinforcement-means (28);

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 (7) 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 (27) of the pump-outflow-cannula (23) is fixed at the heart (2) and/or at the associated vessel, in particular the pump-outflow-cannula (23) is fixed by a sewing technique;

and/or

said blood handling system is connected with the distal-end (6) of the pump-inflow-cannula (1) and/or with the distal-end (26) of the pump-outflow-cannula (23).