Transseptal puncture apparatus

• US 8,992,556 B2
• Filed: 03/23/2012
• Issued: 03/31/2015
• Est. Priority Date: 11/06/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Pressure Products Medical Supplies Incorporated
• Inventors: Chanduszko, Andrzej J., Devellian, Carol A.
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US13/428,719
• Publication Number:
  US 20120179188A1
• Time in Patent Office: 1,103 Days
• Field of Search: 606/185, 606/41, 606/151, 606/213, 606/222, 606/223, 604/96.1, 600/411
• 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 transseptal puncture device for puncturing the atrial septum of a patient, comprising:

a solid inner needle configured for placement within a lumen of a needle configured to transverse the septum and moveable beyond the distal end of the needle, the solid inner needle including a proximal portion, an intermediate portion, and a distal portion;

wherein the solid inner needle is formed substantially of Nitinol;

wherein the intermediate portion is more flexible than the proximal portion and has a circumference equal to that of the proximal portion;

wherein the distal portion is generally curved, is more flexible than the proximal portion, and includes a tip configured to pierce the atrial septum; and

wherein the distal portion has sufficient stiffness such that it is configured to penetrate the atrial septum when the distal portion substantially resides within the needle and has insufficient stiffness such that it is configured to not penetrate cardiac tissue when the distal portion resides substantially outside of the needle.

2. The transseptal puncture device of claim 1, wherein the intermediate portion has been annealed at 500°

C.

3. The transseptal puncture device of claim 1, wherein the intermediate portion of the solid inner needle is formed using a first process that includes a heat-treatment at a first temperature and the other portions of the solid inner needle is formed using a second process that includes a heat-treatment at a second temperature, wherein the first and second temperatures are different and the intermediate portion and the other portions of the solid inner needle formed by the second processes have different flexibility properties.

4. The transseptal puncture device of claim 1, wherein a distal tip portion of the distal portion is generally straight.

5. The transseptal puncture device of claim 1, wherein a distal tip portion of the distal portion is bent.

6. The transseptal puncture device of claim 1, wherein at least part of the distal portion forms a hook shape.

7. The transseptal puncture device of claim 1, wherein the distal portion is curved about 180°

.

8. The transseptal puncture device of claim 1, wherein the intermediate portion has an outer diameter ranging from about 0.1 mm to about 0.5 mm.

9. The transseptal puncture device of claim 1, wherein the distal portion includes a cut-away portion.

10. The transseptal puncture device of claim 1, wherein at least one of the distal portion and the intermediate portion has a cross-sectional area that is smaller than the cross-sectional area of the proximal portion.

11. The transseptal puncture device of claim 1, wherein the distal portion has a longitudinal length ranging from about 5 mm to about 30 mm.

12. The transseptal puncture device of claim 1, wherein the distal portion has a longitudinal length ranging from about 10 mm to about 20 mm.

13. The transseptal puncture device of claim 1, wherein the intermediate portion is generally straight.

14. The transseptal puncture device of claim 1, wherein the intermediate portion has a longitudinal length ranging from about 0.5 mm to about 30 mm.

15. The transseptal puncture device of claim 1, wherein the intermediate portion has a longitudinal length ranging from about 10 mm to about 20 mm.

16. The transseptal puncture device of claim 1, wherein the nominal cross-sectional area of the solid inner needle at any first location along the length of the intermediate portion or the distal portion is equal to or greater than the nominal cross-sectional area of the solid inner needle at any second location distal of the first location.

17. The transseptal puncture device of claim 16, wherein the nominal cross-sectional area of the solid inner needle at any first location along the length of the proximal portion, the intermediate portion, or the distal portion is equal to or greater than the nominal cross-sectional area of the solid inner needle at any second location distal of the first location.

18. The transseptal puncture device of claim 1, wherein the intermediate portion of the solid inner needle includes slits.

19. A transseptal puncture device for puncturing the atrial septum of a patient, comprising:

a solid inner needle configured for placement within a lumen of a needle configured to transverse the septum and moveable beyond the distal end of the needle, the solid inner needle including a proximal portion, an intermediate portion, and a distal portion;

wherein the solid inner needle is formed substantially of Nitinol;

wherein the intermediate portion is more flexible than the proximal portion and has a circumference equal to that of the proximal portion;

wherein the distal portion is generally curved, is generally thinner than the intermediate portion, and includes a tip configured to pierce the atrial septum;

wherein the distal portion has sufficient stiffness such that it is configured to penetrate the atrial septum when the distal portion substantially resides within the needle and has insufficient stiffness such that it is configured to not penetrate cardiac tissue when the distal portion resides substantially outside of the needle; and

wherein at least part of the distal portion is substantially ellipsoidal.

20. The transseptal puncture device of claim 19, wherein the ellipsoidal distal region has a thinner outer dimension and a thicker outer dimension, and at least part of the intermediate portion has an outer diameter that is less than the thicker outer dimension and is greater than the thinner outer dimension.

21. The transseptal puncture device of claim 19, wherein the intermediate portion of the solid inner needle includes slits.

22. A transseptal puncture device for puncturing the atrial septum of a patient, comprising:

a solid inner needle configured for placement within a lumen of a needle configured to transverse the septum and moveable beyond the distal end of the needle;

wherein the solid inner needle includes a proximal portion, an intermediate portion, and a distal portion having a tip configured to pierce the atrial septum;

wherein the solid inner needle is formed substantially of Nitinol;

wherein the intermediate portion is more flexible than the proximal portion and has a circumference equal to that of the proximal portion;

wherein the distal portion has sufficient stiffness such that it is configured to penetrate the atrial septum when the distal portion substantially resides within the needle and has insufficient stiffness such that it is configured to not penetrate cardiac tissue when the distal portion resides substantially outside of the needle; and

wherein the distal portion has a central axis biased in a curved configuration to define a distal curve such that the solid inner needle forms a curved configuration when at least part of the distal portion extends beyond the distal end of the needle and assumes a generally straight configuration when the distal portion resides within the lumen of the needle.

23. The transseptal puncture device of claim 22, wherein the distal portion of the solid inner needle comprises a distal tip portion that deviates from the linear path of the solid inner needle when not constrained within the lumen of the needle.

24. The transseptal puncture device of claim 22, wherein the distal portion, when residing generally outside the lumen of the needle, forms at least one of a curve shape and a hook shape.

25. The transseptal puncture device of claim 22, wherein the device is moveable between a piercing configuration in which at least part of the distal portion of the solid inner needle is located within the lumen of the needle and a non-piercing configuration wherein at least part of the intermediate portion is located outside the lumen of the needle.

26. The transseptal puncture device of claim 22, wherein the intermediate portion of the solid inner needle includes slits.