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

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.
Description

In the following, the invention will be explained in more detail with reference to the drawings. Shown are:



FIG. 1: a pump-inflow-cannula with angled-holes;



FIG. 2: a pump-inflow-cannula with elongated-holes;



FIG. 3: an angled-hole with edge-radii;



FIG. 4: a pump-outflow-cannula;



FIG. 5: a barbed fitting joint;



FIG. 6: a tunneler-plug;



FIG. 6
a a tunneler-cap;



FIG. 7: a sewing-ring accessory;



FIG. 7
a: a sewing-ring in accordance with FIG. 7 attached to a heart;



FIG. 7
b: bottom view of FIG. 7a;



FIG. 8: a pump-outflow-cannula incorporating no vascular graft;


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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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).
  • 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);
Provisional Applications (1)
Number Date Country
60776359 Feb 2006 US