Transseptal puncture apparatus

• US 20050101984A1
• Filed: 05/07/2004
• Published: 05/12/2005
• Est. Priority Date: 11/06/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: NMT Medical Incorporated
• Inventors: Chanduszko, Andrzej J., Devellian, Carol A.
• Granted Patent: US 7,666,203 B2
• Time in Patent Office: Days
• US Class Current: 606/185
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/06095 pliable

Abstract

Devices and methods for performing a transeptal puncture procedure are described. In certain embodiments, the device includes a blunt outer needle, and a second inner needle disposed longitudinally through the lumen of the outer needle, wherein the inner needle is flexible, e.g., has a flexible portion and/or a bend or other non-traumatic conformation at its tip.

Claims

1. A device for puncturing the atrial septum of a patient, comprising:

a first, outer needle comprising a blunt distal end and a lumen longitudinally disposed therethrough; and

a second, inner needle axially disposed in the lumen of the outer needle, the second needle comprising a proximal portion, an intermediate portion, and a distal portion, wherein the intermediate portion is flexible relative to the proximal portion or the distal portion of the inner needle.

2. The device of claim 1, wherein the intermediate portion comprises a polymer.

3. The device of claim 1, wherein the intermediate portion comprises a waist.

4. The device of claim 1, wherein the distal portion comprises a bend.

5. The device of claim 1, wherein the distal portion comprises a shape selected from the group consisting of a taper, a helix, a curve, a cork screw, and a hook.

6. The device of claim 1, wherein the intermediate portion comprises a segment about 5 mm to about 30 mm from the distal end of the inner needle.

7. The device of claim 1, wherein the intermediate portion comprises a segment of about 20 mm from the distal end of the inner needle.

8. The device of claim 1, wherein the intermediate portion is about 0.5 mm to about 30 mm in length.

9. The device of claim 1, wherein the intermediate portion is about 2 mm in length.

10. The device of claim 1, wherein the intermediate portion is tapered.

11. The device of claim 3, wherein the waist is about 0.1 mm to about 0.5 mm in diameter.

12. The device of claim 3, wherein the waist is about 0.1 mm to about 1 mm in diameter.

13. A method for puncturing the atrial septum of a patient'"'"'s heart, comprising:

accessing the right atrium via a vessel;

introducing into the right atrium a transseptal puncture device comprising a first, outer needle comprising a blunt distal end and a lumen longitudinally disposed therethrough, and a second, inner needle axially disposed in the lumen of the outer needle, the inner needle comprising a proximal portion, an intermediate portion, and a distal portion, wherein the intermediate portion is flexible relative to the proximal portion or the distal portion;

contacting the outer needle with the atrial septum;

pushing the inner needle through the septum in advance of the outer needle; and

withdrawing the transseptal puncture device.

14. The method of claim 13, wherein the transeptal puncture device further comprises s sheath through which the outer needle is axially disposed and wherein the method further comprises the step of advancing the sheath through the septum.

15. The method of claim 13, wherein the transeptal puncture device further comprises a sheath through which the outer needle is axially disposed and wherein the method further comprises the step of advancing the sheath through the septum and removing the outer needle.

16. The method of claim 13, further comprising the step of using a locator device to anchor the atrial septum prior to puncture.

17. A device for puncturing the atrial septum of a patient, comprising:

a first, outer needle comprising a blunt distal end and a lumen longitudinally disposed therethrough; and

a second, inner needle axially disposed in the lumen of the outer needle, the inner needle comprising a distal portion that deviates from the linear path of the needle.

18. The device of claim 17, wherein the distal portion comprises a bend.

19. The device of claim 17, wherein the distal portion comprises a taper, a helical, curved, cork screw, or hooked shape.

20. A device for puncturing the atrial septum of a patient, comprising:

a first, outer needle comprising a blunt distal end and a lumen longitudinally disposed therethrough; and

a second, inner needle axially disposed in the lumen of the outer needle, the inner needle comprising a proximal portion and a distal portion, wherein the diameter of the distal portion is smaller than the diameter of the proximal portion.

21. The device of claim 20, further comprising an intermediate portion between the distal portion and the proximal portion, wherein the intermediate portion is tapered.