COAXIAL TRANSSEPTAL GUIDE-WIRE AND NEEDLE ASSEMBLY

• US 20110054487A1
• Filed: 06/07/2010
• Published: 03/03/2011
• Est. Priority Date: 09/02/2009
• Status: Abandoned Application

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Farnan, Robert C.
• Application Number:
  US12/794,847
• Publication Number:
  US 20110054487A1
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A coaxial transseptal device and methods of piercing a tissue within the heart. The coaxial transseptal device includes a piercing device having a shaft with a distal sharpened portion. The coaxial transseptal device also includes a coaxial guide-wire configured to receive the piercing device and move relative thereto. The flexibility of the coaxial guide-wire increases from the proximal end to the distal end.

Claims

1. A coaxial transseptal device comprising:

a piercing device comprising a shaft having a proximal end and a distal end, wherein a sharpened portion is included on the distal end; and

a coaxial guide-wire configured to receive the piercing device and move relative thereto, the coaxial guide-wire having a proximal end and a distal end, wherein a flexibility of the coaxial guide-wire increases distally.

2. The coaxial transseptal device of claim 1, wherein the coaxial guide-wire includes a tube having a helical cut on a distal end of the tube for increasing the flexibility of the coaxial guide-wire.

3. The coaxial transseptal device of claim 2, wherein the helical cut has a pitch that varies along the tube, whereby the pitch is smaller at a distal end than at a proximal end of the helical cut.

4. The coaxial transseptal device of claim 2, wherein the coaxial guide-wire includes a coil surrounding at least the distal portion of the tube.

5. The coaxial transseptal device of claim 4, wherein a direction of the helical cut opposes a direction of the coil.

6. The coaxial transseptal device of claim 1, wherein the coaxial guide-wire includes a radial tip at the distal end.

7. The coaxial transseptal device of claim 6, wherein the radial tip is constructed from a radiopaque material.

8. The coaxial transseptal device of claim 1, wherein a flexibility of the shaft of the piercing device increases distally.

9. The coaxial transseptal device of claim 8, wherein the shaft of the piercing device includes a helical cut section on a distal end for increasing the flexibility.

10. The coaxial transseptal device of claim 9, wherein the helical cut section has a pitch that varies along the shaft, whereby the pitch is smaller at a distal end than at a proximal end of the helical cut section.

11. The coaxial transseptal device of claim 9, wherein the helical cut section has a depth that varies along the shaft, whereby the depth is deeper at a distal end than at a proximal end of the helical cut section.

12. The coaxial transseptal device of claim 1, wherein the piercing device includes a hub on the proximal end of the shaft that is adapted to enable the manipulation of the piercing device.

13. The coaxial transseptal device of claim 12 further comprising:

a safety clip configured to attach to the shaft of the piercing device between the hub and the proximal end of the coaxial guide-wire, wherein the safety clip prevents the sharpened portion of the piercing device from extending beyond the distal end of the coaxial guide-wire.

14. The coaxial transseptal device of claim 1, wherein the coaxial guide-wire further comprises:

a removable adapter connected to the proximal end of the coaxial guide-wire and that couples to a pressure monitor for measuring a pressure within a chamber of the heart.

15. A guide-wire comprising:

a tube having proximal and distal ends with a lumen extending therebetween, wherein the flexibility of the tube increases distally; and

a coil surrounding at least the distal end of the tube.

16. The guide-wire of claim 15, wherein the tube includes a helical cut on the distal end that increases the flexibility of the tube.

17. The guide-wire of claim 16, wherein the helical cut includes a pitch that varies along the tube, whereby the pitch is smaller at a distal end than at a proximal end of the helical cut.

18. The guide-wire of claim 16, wherein a direction of the helical cut of the tube opposes a direction of the coil surrounding the tube.

19. The guide-wire of claim 15 further comprising:

a sleeve surrounding the proximal end of the tube and configured to decrease the flexibility of the proximal end of the tube.

20. The guide-wire of claim 15 further comprising:

a removable adapter connected to the proximal end of the tube, the removable adapter coupled to a pressure monitor for measuring a pressure within a chamber of the heart.

21. The guide-wire of claim 15, wherein the lumen of the guide-wire receives a tissue piercing device.

22. A piercing device comprising:

a shaft having a proximal end and a distal end; and

a sharpened portion on the distal end of the shaft, wherein the flexibility of the shaft increases distally.

23. The piercing device of claim 22, wherein the shaft includes a helical cut section on the distal end that increases the flexibility of the distal end of the shaft.

24. The piercing device of claim 23, wherein the helical cut section includes a pitch that varies along the shaft, whereby the pitch is smaller at a distal end than at a proximal end of the helical cut section.

25. The piercing device of claim 23, wherein the helical cut section includes a depth that varies along the shaft, whereby the depth is deeper at a distal end than at a proximal end of the helical cut section.

26. The piercing device of claim 22 further comprising:

a hub attached to the proximal end of the shaft and adapted to enable the manipulation of the piercing device.

27. A method of piercing a tissue within the heart with a coaxial transseptal device comprising a piercing device and a coaxial guide-wire, the piercing device comprising a shaft having a proximal end, a distal end, and having a sharpened portion on the distal end, the coaxial guide-wire having a proximal end and a distal end, wherein a flexibility of the coaxial guide-wire increases distally, and the coaxial guide-wire is configured to receive the piercing device and move relative thereto, the method comprising:

introducing the distal end of the coaxial guide-wire into a superficial blood vessel;

percutaneously directing the distal end of the coaxial guide-wire from the superficial blood vessel to the tissue in a first chamber of the heart;

advancing the sharpened portion of the piercing device distally beyond the distal end of the coaxial guide-wire, thereby puncturing the tissue and entering a second chamber of the heart; and

advancing the distal end of the coaxial guide-wire over the piercing device and into the second chamber, thereby dilating the puncture in the tissue.

28. The method according to claim 27, wherein the superficial blood vessel is a subclavian vein, a jugular vein, a femoral vein, or an iliac vein.

29. The method according to claim 27 further comprising:

advancing a guide catheter to the first chamber before percutaneously directing the distal end of the coaxial guide-wire into the superficial blood vessel.

30. The method according to claim 27, wherein the coaxial guide-wire further includes a removable adapter on the proximal end, the removable adapter being also coupled to a pressure monitor and configured to measure a pressure within the second chamber of the heart.

31. The method according to claim 27, wherein the first chamber is the right atrium, the second chamber is the left atrium, and the tissue is an intra-atrial septum.

32. A method of puncturing a tissue within the heart with a coaxial transseptal device comprising a piercing device and a coaxial guide-wire, the piercing device comprising a shaft having a proximal end, a distal end, and having a sharpened portion on the distal end, the coaxial guide-wire having a proximal end and a distal end, wherein a flexibility of the coaxial guide-wire increases distally and the coaxial guide-wire is configured to receive the piercing device and move relative thereto, the method comprising:

securing the sharpened portion of the piercing device within the coaxial guide-wire;

introducing the distal end of the coaxial guide-wire into a superficial blood vessel;

percutaneously directing the distal end of the coaxial guide-wire from the superficial blood vessel to the tissue in a first chamber of the heart;

releasing the sharpened portion such that the shaft moves relative to the coaxial guide-wire;

advancing the sharpened portion of the piercing device distally beyond the distal end of the coaxial guide-wire, thereby puncturing the tissue and entering a second chamber of the heart;

advancing the distal end of the coaxial guide-wire across the intra-atrial septum and into the second chamber, thereby dilating the puncture in the tissue; and

retracting the piercing device from the coaxial guide-wire.

33. The method according to claim 32, wherein the superficial blood vessel is a subclavian vein, a jugular vein, a femoral vein, an iliac vein.

34. The method according to claim 32 further comprising:

directing a guide catheter into the superficial blood vessel before introducing the distal end of the coaxial guide-wire.

35. The method according to claim 32, wherein the piercing device includes a hub on the proximal end of the shaft to enable the manipulation of the piercing device.

36. The method according to claim 35, wherein a safety clip secures the sharpened portion within the coaxial guide-wire, the safety clip including a clip portion that attaches to the shaft of the piercing device between the hub and the proximal end of the coaxial guide-wire.

37. The method according to claim 32, wherein the distal end of the coaxial guide-wire includes a radial tip constructed from a radiopaque material for in vivo localization.

38. The method according to claim 32, wherein the coaxial guide-wire includes a coil constructed from a radiopaque material for in vivo localization.

39. The method according to claim 32, wherein the distal end of the shaft is constructed from a radiopaque material for in vivo localization.

40. The method according to claim 32, wherein the sharpened portion of the piercing device is constructed from a radiopaque material for in vivo localization.