Introducer and perfusion cannula

• US 6,669,674 B1
• Filed: 05/08/2000
• Issued: 12/30/2003
• Est. Priority Date: 09/26/1997
• Status: Expired due to Fees

• Current Assignee: Cardeon Corporation
• Original Assignee: Cardeon Corporation
• Inventors: Thompson, Lynn M., Macoviak, John A., Leary, James J., Samson, Wilfred J.
• Primary Examiner(s): Mendez, Manuel
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/566,859
• Time in Patent Office: 1,331 Days
• Field of Search: 604/103.04, 604/173-175, 604/264, 604/523, 604/539, 604/533, 604/284, 604/43, 604/178, 604/158, 604/164.01, 604/167.01, 604/256, 604/165.01, 604/104, 600/213, 600/167, 600/198
• US Class Current: 604/264
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 2017/3447 Linked multiple cannulas
• 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 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like

Abstract

The present invention discloses a multi-access cannula for use in a variety of surgical procedures, particularly for use in the course of performing conventional open-chest and peripheral access cardiopulmonary bypass (CPB). The multi-access cannula is capable of being inserted through a single puncture site with a percutaneous tip. At the appropriate depth of insertion, a closure seal may be engaged at the point of entry to secure the positioning of the cannula and prevent leakage of blood from the incision. Once the cannula is at the appropriate position the cannula provides a multiplicity of procedural options for the surgeon. For example, when approaching through the ascending aorta, the multi-access cannula enables the simultaneous passage of various fluids and multiple catheters or instruments in opposing directions within the lumen of the aortic arch through a single insertion site.

Claims

1. A multi-access perfusion cannula comprising:

(a) an elongated tubular cannula body including a plurality of pivoting access legs;

(b) a downstream directed perfusion lumen within said elongated tubular cannula body;

(c) an upstream directed access conduit within said elongated tubular cannula body configured for passage of a catheter or instrument; and

(d) an intra-luminal flow control regulator, said intra-luminal flow control regulator capable of at least partially occluding a vessel.

2. The multi-access perfusion cannula of claim 1, wherein said perfusion lumen comprises a proximal port and a distal perfusion port, said proximal port in being communication with said perfusion lumen and said distal perfusion port being in communication with said perfusion lumen, said perfusion lumen being of sufficient cross-sectional size and shape to provide for compatibility with insertable catheters and perfusion blood flow for cardiopulmonary support.

3. The multi-access perfusion cannula of claim 1, wherein said said plurality of pivoting access legs comprise a first pivoting access leg and a second pivoting access leg, said perfusion lumen extending through said first pivoting access leg, said perfusion lumen being of sufficient size and shape to provide perfusion to blood flow for cardiopulmonary support and compatibility with insertable catheters, said access conduit extending through said second pivoting access leg, said access conduit being capable of directing a second insertable catheter in an upstream direction opposing that of said first pivoting access leg, said access conduit being of sufficient cross sectional size and shape to provide for compatibility with insertable catheters and flow of cardioplegic agent.

4. The multi-access perfusion cannula of claim 1 further comprising a locking mechanism for selectively locking said pivoting access legs in an active position wherein said pivoting access legs supply multi-direction flow in a downstream direction and an upstream direction simultaneously and independently.

5. The multi-access perfusion cannula of claim 1 further comprising at least one hemostasis valve having a passage therethrough and capable of maintaining a fluidly tight seal upon introduction of an extendable member.

6. The multi-access perfusion cannula of claim 1, further comprising an insertion tip capable of percutaneous entrance into a vessel.

7. A multi-access perfusion cannula comprising:

(a) an elongated tubular cannula body including a plurality of articulating access legs;

(b) a downstream directed perfusion lumen within said elongated tubular cannula body;

(c) an upstream directed access conduit within said elongated tubular cannula body configured for passage of a catheter or instrument; and

(d) a sealing mechanism having a proximal portion and a distal portion, said proximal portion covering an insertion site on an outside surface of a vessel wall by securing a distal surface of said proximal portion of said sealing mechanism against the outside surface of the vessel, said distal portion of said sealing mechanism lying intraluminally of the vessel wall with a proximal surface of said distal portion of said sealing mechanism bearing against the inside surface of the vessel.

8. The multi-access perfusion cannula of claim 7, wherein said perfusion lumen comprises a proximal port and a distal perfusion port, said proximal port being in communication with said perfusion lumen and said distal perfusion port being in communication with said perfusion lumen, said perfusion lumen being of sufficient cross-sectional size and shape to provide for compatibility with insertable catheters and perfusion blood flow for cardiopulmonary support.

9. The multi-access perfusion cannula of claim 7, wherein said said plurality of articulating access legs comprise a first articulating access leg and a second articulating access leg, said perfusion lumen extending through said first articulating access leg, said perfusion lumen being of sufficient size and shape to provide perfusion to blood flow for cardiopulmonary support and compatibility with insertable catheters, said access conduit extending through said second articulating access leg, said access conduit being capable of directing a second insertable catheter in an upstream direction opposing that of said first articulating access leg, said access conduit being of sufficient cross sectional size and shape to provide for compatibility with insertable catheters and flow of cardioplegic agent.

10. The multi-access perfusion cannula of claim 9 further comprising an articulating mechanism including a first articulating cord and a second articulating cord, said first articulating cord having a proximal end and a distal end, said distal end fixedly attached to said first articulating access leg, engagement of said first articulating cord causing articulation of first articulating access leg, said second articulating cord having a proximal end and a distal end, said distal end fixedly attached to said second articulating access leg, engagement of said second articulating cord causing articulation of second articulating access leg, said first articulating access leg and said second articulating access leg being deployable simultaneously or independently and in differing degrees of articulation.

11. The multi-access perfusion cannula of claim 7 further comprising a locking mechanism for selectively locking said articulating access legs in an active position wherein said articulating access legs supply multi-direction flow in a downstream direction and an upstream direction.

12. The multi-access perfusion cannula of claim 7 further comprising an intra-luminal flow control regulator, said intra-luminal flow control regulator capable of at least partially occluding a vessel.

13. The multi-access perfusion cannula of claim 7, further comprising at least one hemostasis valve, said hemostasis valve having a passage therethrough and capable of maintaining a fluidly tight seal upon introduction of an extendable member.

14. The multi-access perfusion cannula of claim 7, further comprising an insertion tip capable of percutaneous entrance into a vessel.

15. A multi-access perfusion cannula comprising:

(a) an elongated tubular cannula body including a plurality of pivoting access legs;

(b) a downstream directed perfusion lumen within said elongated tubular cannula body;

(c) an upstream directed access conduit within said elongated tubular cannula body configured for passage of a catheter or instrument; and

(d) a sealing mechanism for sealing an insertion site of said cannula body into a vessel, having a proximal portion and a distal portion, said proximal portion covering the insertion site on an outside surface of a vessel wall by securing a distal surface of said proximal portion of said sealing mechanism against the outside surface of the vessel, said distal portion of said sealing mechanism lying intraluminally of the vessel and covering the insertion site on an inside surface of the vessel wall with a proximal surface of said distal portion of said sealing mechanism bearing against the inside surface of the vessel.

16. The multi-access perfusion cannula of claim 15 further comprising a compression mechanism for urging said proximal portion and said distal portion into engagement with the wall of the vessel.

17. The multi-access perfusion cannula of claim 16, wherein said portion comprises a proximal sealing disk and said distal portion comprises a distal sealing disk, and said compression mechanism for urging proximal portion and said distal portion into engagement with the wall of the vessel comprises a hollow threaded stem connecting said proximal sealing disk.

18. The multi-access perfusion cannula of claim 15, wherein said distal portion is attached to said cannula body and said proximal portion is slidable along said cannula body to engage the outside surface of the vessel.

19. The multi-access perfusion cannula of claim 15 further comprising a central passage extending through said proximal portion and said distal portion for providing access to the lumen vessel.

20. The multi-access perfusion cannula of claim 15 further comprising a hemostasis valve within said central passage, said hemostasis valve having a passage therethrough and capable of maintaining a fluidly tight seal upon introduction of an instrument through said central passage.

21. The multi-access perfusion cannula of claim 15, wherein said proximal portion comprises a proximal inflatable seal and said distal portion comprises a distal inflatable seal.

22. The multi-access perfusion cannula of claim 15, wherein said distal portion comprises an inner expandable member selectively expandable to engage the inner surface of the vessel.

23. The multi-access perfusion cannula of claim 22, wherein said inner expandable member comprises a slotted sleeve that expands radially when compressed axially to engage the inner surface of the vessel.

24. The multi-access perfusion cannula of claim 22, wherein said proximal portion comprises an outer expandable member selectively expandable to engage the outer surface of the vessel.

25. The multi-access perfusion cannula of claim 24, wherein said outer expandable member comprises a slotted sleeve that expands radially when compressed axially to engage the outer surface of the vessel.

26. A multi-access perfusion cannula comprising:

(a) an elongated tubular cannula body including a plurality of articulating access legs;

(b) a downstream directed perfusion lumen within said elongated tubular cannula body;

(c) an upstream directed access conduit within said elongated tubular cannula body configured for passage of a catheter or instrument; and

(d) a sealing mechanism for sealing an insertion site of said cannula body into a vessel, having a proximal portion and a distal portion, said proximal portion covering the insertion site on an outside surface of a vessel wall by securing a distal surface of said proximal portion of said sealing mechanism against the outside surface of the vessel, said distal portion of said sealing mechanism lying intraluminally of the vessel and covering the insertion site on an inside surface of the vessel wall with a proximal surface of said distal portion of said sealing mechanism bearing against the inside surface of the vessel.

27. The multi-access perfusion cannula of claim 26 further comprising a compression mechanism for urging said proximal portion and said distal portion into engagement with the wall of the vessel.

28. The multi-access perfusion cannula of claim 27, wherein said portion comprises a proximal sealing disk and said distal portion comprises a distal sealing disk, and said compression mechanism for urging proximal portion and said distal portion into engagement with the wall of the vessel comprises a hollow threaded stem connecting said proximal sealing disk.

29. The multi-access perfusion cannula of claim 26 wherein said distal portion is attached to said cannula body and said proximal portion is slidable along said cannula body to engage the outside surface of the vessel.

30. The multi-access perfusion cannula of claim 26 further comprising a central passage extending through said proximal portion and said distal portion for providing access to the lumen vessel.

31. The multi-access perfusion cannula of claim 26 further comprising a hemostasis valve within said central passage, said hemostasis valve having a passage therethrough and capable of maintaining a fluidly tight seal upon introduction of an instrument through said central passage.

32. The multi-access perfusion cannula of claim 26, wherein said proximal portion comprises a proximal inflatable seal and said distal portion comprises a distal inflatable seal.

33. The multi-access perfusion cannula of claim 26, wherein said distal portion comprises an inner expandable member selectively expandable to engage the inner surface of the vessel.

34. The multi-access perfusion cannula of claim 33, wherein said inner expandable member comprises a slotted sleeve that expands radially when compressed axially to engage the inner surface of the vessel.

35. The multi-access perfusion cannula of claim 33, wherein said proximal portion comprises an outer expandable member selectively expandable to engage the outer surface of the vessel.

36. The multi-access perfusion cannula of claim 35, wherein said outer expandable member comprises a slotted sleeve that expands radially when compressed axially to engage the outer surface of the vessel.