Percutaneous transseptal left atrial cannulation system

• US 5,190,528 A
• Filed: 10/19/1990
• Issued: 03/02/1993
• Est. Priority Date: 10/19/1990
• Status: Expired due to Term

• Current Assignee: Boston University, Johns Hopkins University, DLM Incorporated (Medtronic Plc)
• Original Assignee: Boston University
• Inventors: Mitchell, Sally E., Jonkman, Kenneth R., Fonger, James D., Anderson, James H.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): LAVIOLA JR, FRANK
• Application Number:
  US07/600,483
• Time in Patent Office: 865 Days
• Field of Search: 604/158, 604/161, 604/164, 604/165, 604/166, 604/167, 604/168, 604/169, 604/170, 604/171, 604/280, 604/281, 604/282, 604/284, 128/656, 128/657, 128/658
• US Class Current: 604/171
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/0668 splittable, tear apart

Abstract

A transseptal left atrial cannulation system which provides drainage of left atrial blood without the need for thoracotomy. A guide wire and a long needle assembly are inserted into a catheter. A cannula rides over the exterior of this catheter. The guide wire may be advanced past the needle assembly and through a catheter through the distal end of the catheter to assist in directing the system to the right atrium. The cannulation system is inserted in a femoral vein located in the groin. Both the guide wire and needle assembly are long enough to allow a substantial length to extend out of the body at the groin for manipulation even when the distal ends of the guide wire and needle assembly are positioned in the heart. When the catheter distal end is positioned adjacent the septum in the right atrium, the guide wire is withdrawn from the catheter orifice and the needle assembly moves past the guide wire and through the catheter orifice to a position adjacent to the septum. The needle pierces the septum and the catheter moves over the needle assembly to further dilate the septal hole. The cannula attached to the catheter also moves through the septal hole, further dilating it, and resting with the holes in the left atrium. The guide wire, the needle assembly, and the catheter are withdrawn from the cannula. Oxygenated blood from the left atrium drains through the cannula to the extracorporeal pump and back to the body through an arterial cannula.

Claims

1. A cannulation system for draining blood from the left atrium of the heart through a blood vessel comprising, as an assembly to be inserted through the blood vessel:

a catheter having a distal end and a proximal end, said distal end including an orifice and the catheter width being reduced near the orifice;

a guide wire;

a needle;

said guide wire and said needle located axially in the catheter such that either the guide wire or the needle can alternately be extended through the orifice at the catheter distal end; and

a cannula, having a distal end and a proximal end, surrounding the catheter, said cannula having a hole located at the extreme distal end of the cannula such that the hole of the cannula slides over the exterior of the catheter, the needle having a stiffness sufficient to serve as an obturator such that the catheter and cannula can be passed over the needle and through the atrial septum, but flexible enough to pass through a blood vessel.

2. A cannulation system as claimed in claim 1 wherein the needle has shape memory and the catheter and cannula are straight but for shape imparted by the needle.

3. A cannulation system for accessing blood in the left atrium through a blood vessel comprising, as an assembly to be inserted through the blood vessel:

a catheter having a distal end and a proximal end and an axial cavity, said distal end including an orifice and the catheter width being reduced near the orifice;

a guide wire;

a needle;

said guide wire and said needle located axially in the catheter such that either the guide wire or the needle can alternately be extended through the orifice at the catheter distal end; and

a cannula, having a distal end and a proximal end, surrounding the catheter, said cannula having a hole located at the extreme distal end of the cannula such that the hole of the cannula slides over the exterior of the catheter.

4. A cannulation system, as recited in claim 3, further comprising:

a plurality of holes on the side of said cannula;

a peel-away sheath assembly including a thin-walled tube with a tapered end which causes the sheath to be retained in fixed portion on the cannula as the cannula is moved through subcutaneous tissue to cover the plurality of holes on the side of the cannula,

said tube being scored such that it can be pulled back from the cannula and peeled away.

5. A cannulation system, as recited in claim 4, further comprising a hub which is molded onto the thin-walled tube.

6. A cannulation system, as recited in claim 5, in which the cannula is coated with an anti-thrombogenic coating.

7. A cannulation system, as recited in claim 6, in which the needle is sufficiently stiff to direct the catheter and then the cannula over the needle.

8. A cannulation system, as recited in claim 7, in which the guide wire has a curved flexible end such that the guide wire can guide the cannulation system in a blood vessel and the guide wire can be extended from the catheter orifice to assess the distance from the catheter orifice to a body part.

9. A cannulation system, as recited in claim 8, in which the needle further comprising an inner metal tube and an outer metal tube, such that the inner metal tube is longer and narrower than the outer metal tube and a molded hub which joins the inner and outer metal tubes coaxially, said inner metal tube has a distal end which is rounded to prevent scraping within the catheter, said inner metal tube can pass through the catheter orifice, said outer metal tube cannot pass through the catheter orifice such that the inner metal tube protrudes a fixed distance from the catheter orifice.

10. A cannulation system, as recited in claim 9, in which the distal end of the needle may be curved.

11. A cannulation system, as recited in claim 10, in which said inner and outer metal tubes have a proximal end, said needle proximal end further comprising a hub with a pointer such that the angular orientation of the pointer indicates the spatial orientation of the curved distal end of the needle.

12. A cannulation system, as recited in claim 11, in which said needle further comprising a needle wire with a distal end and a proximal end, and a molded hub attached to the needle wire proximal end, said needle wire is positioned within the inner metal tube such that movement of the molded hub towards the catheter distal end advances the needle wire distal end through the inner metal tube distal end.

13. A cannulation system, as recited in claim 3, in which the cannula is coated with an anti-thrombogenic coating.

14. A cannulation system, as recited in claim 3, in which the needle is sufficiently stiff to permit the catheter and cannula to advance through the atrial septum over the needle assembly.

15. A cannulation system, as recited in claim 14, further comprising a guide wire and needle length which are long enough to allow a substantial length to extend out of the body at the groin for manipulation even when the distal ends of the guide wire and needle are positioned in the heart.

16. A cannulation system, as recited in claim 3, in which the guide wire has a curved flexible end such that the guide wire can guide the cannulation system in a vein and the guide wire can be extended from the catheter orifice to assess the distance from the catheter orifice to the left atrial wall.

17. A cannulation system, as recited in claim 16, in which the guide wire is further comprised of a core wire and a stainless steel spring wire such that said spring wire is wrapped around said core wire.

18. A cannulation system, as recited in claim 3, further comprising a guide wire and needle length which are long enough to allow a substantial length to extend out of the body at the groin for manipulation even when the distal ends of the guide wire and needle are positioned in the heart.

19. A cannulation system, as recited in claim 3, in which the needle further comprises a metal tube with a narrowed distal end such that a predetermined length of tube can extend out of the catheter orifice but a thicker tube width is stopped at the orifice.

20. A cannulation system, as recited in claim 19, in which the tube further comprises an inner metal tube and an outer metal tube, such that the inner metal tube is longer and narrower than the outer metal tube and a molded hub which joins the inner and outer metal tubes coaxially, said inner metal tube having a distal end which is rounded to prevent scraping within the catheter, said inner metal tube being of a diameter to pass through the catheter orifice, said outer metal tube being of a diameter such that it cannot pass through the catheter orifice such that the inner metal tube cannot protrude beyond a fixed distance from the catheter orifice.

21. A cannulation system, as recited in claim 20, in which the distal end of the needle may be preformed to a curve by the operator.

22. A cannulation system, as recited in claim 21, in which said inner and outer metal tubes have a proximal end, said metal tube proximal end further comprising a hub with a pointer such that the angular orientation of the pointer indicates the spatial orientation of the curved distal end of the needle.

23. A cannulation system, as recited in claim 20, in which said transseptal needle further comprises a needle wire with a distal end and a proximal end, and a hub attached to the needle wire proximal end, said needle wire being positioned within the inner metal tube such that movement of the molded hub towards the catheter distal end extends the needle wire distal end through the tube distal end a fixed short distance.

24. A cannulation system, as recited in claim 3, further comprising:

a flexible, hollow cannula hub with a distal end and a proximal end;

said cannula hub distal end being clampable such that blood in the cannula will not pass through the cannula hub proximal end.

25. A cannulation system, as recited in claim 24, further comprising:

a hollow reducer plug with a distal end and a proximal end;

said reducer plug distal end being connected to said cannula hub proximal end; and

said reducer plug proximal end surrounding said catheter proximal end, the interior diameter of the reducer plug being smaller than the interior diameter of the cannula hub.

26. A cannulation system, as recited in claim 25, in which the catheter proximal end further comprises:

a male connector with a distal end and a proximal end, said male connector distal end being coupled to said reducer plug proximal end;

a dual lumen elastic bushing which is positioned in the male connector proximal end;

said bushing holding the guide wire and the needle, said male connector proximal end including a holder for the bushing; and

a closing ring positioned at the male connector proximal end such that a friction fit prevents the guide wire and the needle from moving in the catheter axially if desired.

27. A cannulation system as claimed in claim 3 wherein the needle comprises a tube and a needle wire within the tube which may be extended beyond the tip of the tube or retracted within the tube.

28. A cannulation system as claimed in claim 3 wherein the needle has shape memory and the catheter and cannula are straight but for shape imparted by the needle.

29. A cannula peel-away sheath assembly comprising:

a cannula including a plurality of holes located on the side of the cannula parallel to the longitudinal axis of the cannula; and

a peel-away sheath assembly including a thin-walled tube with a tapered end which causes the sheath to be retained in fixed position on the cannula as the cannula is moved through subcutaneous tissue to cover the plurality of holes on the side of the cannula, such that the sheath assembly prevents the cannula holes from accumulating fat particle debris when passing through subcutaneous fat prior to reaching a blood vessel; and

said tube is scored such that the sheath assembly can be pulled back and peeled away after the cannula is within the blood vessel.

30. An apparatus, as recited in claim 29, further comprising a hub coupled to a proximal end of the tube.

31. A cannulation system for draining blood from the left atrium of the heart through a blood vessel as an assembly to be inserted through the blood vessel:

a catheter having a distal end and a proximal end, said distal end including an orifice and the catheter width being reduced near the orifice;

a guide wire;

a needle;

said guide wire and said needle located axially in the catheter such that either the guide wire or the needle can alternately be extended through the orifice at the catheter distal end;

a cannula, having a distal end and a proximal end, surrounding the catheter, said cannula having a hole located at the extreme distal end of the cannula such that the hole of the cannula rides over the exterior of the catheter;

said needle is sufficiently stiff to direct the catheter and then the cannula over the needle;

a peel-away sheath assembly including a thin-walled tube with a tapered end which causes the sheath to be retained in fixed portion on the cannula as the cannula is moved through subcutaneous tissue to cover the plurality of holes on the side of the cannula;

said thin-walled tube being scored such that it can be pulled back from the cannula and peeled away;

the guide wire has a curved flexible end such that the guide wire can guide the cannulation system in a blood vessel and the guide wire can be advanced from the catheter orifice to assess the distance from the catheter orifice to a body part; and

a needle with a narrowed distal end such that a predetermined length of needle can extend out of the catheter orifice but a thicker needle width is stopped at the orifice.

32. A cannulation system as claimed in claim 31 wherein the needle comprises a tube and a needle wire within the tube which may be extended beyond the tip of the tube or retracted within the tube.

33. A cannulation system as claimed in claim 31 wherein the needle has shape memory and the catheter and cannula are straight but for shape imparted by the needle.

34. A percutaneous transseptal left atrial cannulation system for draining oxygenated blood from the left atrium of the heart through a venous cannula and returning the blood to the body through an arterial cannula after passing through an extra-corporeal pump, said venous cannulation system comprising:

a catheter having a distal end and a proximal end, said distal end including an orifice and the catheter width being reduced near the orifice;

a guide wire;

a needle;

said guide wire and said needle being located axially in the catheter such that either the guide wire or the needle can be alternately advanced through the orifice at the catheter distal end, said needle having a distal end which may be curved; and

a cannula having a distal end and a proximal end, said cannula distal end including a plurality of holes located on the side of the cannula parallel to the longitudinal axis of the cannula and an end hole located at the extreme distal of the cannula;

said end hole of the cannula rides over the exterior of the catheter;

said needle is sufficiently stiff to serve as an obturator to direct the catheter and then the cannula over the needle;

such that said venous cannulation system is adapted to enter the femoral vein, pass up the inferior vena cava, enter the right atrium, position the needle assembly distal end at the septum, pierce the septum to form a hole in the septum and to position the needle assembly distal end in the left atrium, move the catheter over the needle assembly to further dilate the septal hole, move the cannula into the left atrium to further dilate the septal hole, and remove the needle, the guide wire, and the catheter from the cannula to permit flow of oxygenated blood from the left atrium to the extra-corporeal pump and through the arterial cannula back to the body.

35. A method of percutaneous transseptal left atrial ventricular assist for extracting oxygenated flood from the left atrium of the heart by a venous cannulation system and returning the blood to the body by an arterial cannula after passing through an extra-corporeal pump comprising the steps of:

(a) inserting the venous cannulation system into the femoral vein, said venous cannulation system including a guide wire and a needle located in a catheter with a distal end orifice and a cannula riding over the exterior of the catheter;

(b) advancing the guide wire through the catheter orifice and moving the catheter over the guide wire through the inferior vena cava to the septum in the right atrium of the heart;

(c) withdrawing the guide wire into the catheter and extending the needle distal end to the septum;

(d) piercing the septum with the needle to form a hole;

(e) moving the catheter over the needle assembly to further dilate the septal hole;

(f) moving the cannula into the left atrium to further dilate the septal hole;

(g) withdrawing the guide wire, the needle, and the catheter from the cannula; and

(h) draining oxygenated blood from the left atrium through the venous cannula to the extra-corporeal pump and back to the body through the arterial cannula.

36. A method, as recited in claim 35, in which the cannula distal end comprises a plurality of holes located on its side parallel to the longitudinal axis of the cannula, the method comprising covering the cannula holes with a peel-away sheath during the initial step of inserting the venous cannula into the femoral vein such that the sheath prevents the cannula holes from accumulating fat particle debris prior to reaching the blood stream and peeling away the sheath after the cannula is within the femoral vein.

37. A method, as recited in claim 35, in which the needle further comprises a tube with a narrowed distal end such that predetermined length of tube can extend out of catheter orifice.

38. A method, as recited in claim 37, in which the tube further comprises:

an inner metal tube and an outer metal tube, such that the inner metal tube is longer and narrower than the outer metal tube and a molded hub which joins the inner and outer metal tubes coaxially, said inner metal tube has a distal end which is rounded to prevent scraping within the catheter, said inner metal tube can pass through the catheter orifice, said outer metal tube cannot pass through the catheter orifice such that the inner metal tube protrudes a fixed distance from the catheter orifice.

39. A method, as recited in claim 38, in which the distal end of the needle may be curved.

40. A method, as recited in claim 39, in which said inner metal tube has a proximal end, said inner metal proximal end further comprising a hub with a pointer such that the angular orientation of the pointer indicates the spatial orientation of the curved distal end of the needle.

41. A method, as recited in claim 38, in which said transseptal needle assembly further comprises a needle wire with a distal end and a proximal end, and a hub attached to the needle wire proximal end, said needle wire being positioned within the inner metal tube such that movement of the molded hub towards the catheter distal end advances the needle wire distal end through the inner metal tube distal end.

42. A method of inserting a cannula into a blood vessel, said cannula including a plurality of holes located on the side of the cannula parallel to the longitudinal axis of the cannula, comprising the steps of:

(a) attaching a peel-away sheath assembly to the cannula to cover the cannula holes, said peel-away sheath assembly including a thin-walled tube, said tube is scored;

(b) inserting the cannula peel-away sheath assembly into a blood vessel by passing through a subcutaneous layer of fat such that said sheath assembly prevents the cannula holes from accumulating fat particle debris; and

(c) pulling back and peeling away the sheath assembly after the cannula is within the blood vessel.