Method and apparatus for accessing the left atrial appendage

• US 20020169377A1
• Filed: 03/15/2002
• Published: 11/14/2002
• Est. Priority Date: 04/13/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: ev3 Endovascular, Inc.
• Inventors: Kume, Stewart M., Kreidler, Marc S., Khairkhahan, Alexander K., Roue, Chad C., Ogi, Darrell H., van der Burg, Erik J., Frazier, Andrew G.C., Klenk, Alan R.
• Granted Patent: US 7,056,294 B2
• Time in Patent Office: Days
• US Class Current: 600/433
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• 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 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

Disclosed is an apparatus for facilitating access to the left atrium, and specifically the left atrial appendage. The apparatus may comprise a sheath with first and second curved sections that facilitate location of the fossa ovalis and left atrial appendage. The apparatus may further comprise tissue piercing and dilating structures. Methods are also disclosed.

Claims

1. A transseptal access sheath comprising;

a first curved section, and a second curved section;

the first curved section having an outer edge that defines

a first proximal edge point, and

a first distal edge point

wherein the intersection between a tangent drawn to the first curved section at the first proximal edge point and a tangent drawn to the first curved section at the first distal edge point, define a first angle and a first plane;

the second curved section having an outer edge that defines

a second proximal edge point, and

a second distal edge point

wherein the intersection between a tangent drawn to the second curved section at the second proximal edge point and a tangent drawn to the second curved section at the second distal edge point, define a second angle and a second plane;

wherein the first angle is within the range of about 60°

to about 120°

;

wherein the second angle is within the range of about 0° and

about 180°

; and

wherein the angle between the first and second plane is within the range of about 60° and

about 120°

.

2. The transseptal access sheath of claim 1, wherein the first angle is about 90 degrees.

3. The transseptal access sheath of claim 1, wherein the second angle is about 90 degrees.

4. The transseptal access sheath of claim 1, wherein the angle between the first and second plane is within the range of about 60 and about 120 degrees.

5. The transseptal access sheath of claim 1, wherein the sheath is reinforced with braiding.

6. The transseptal access sheath of claim 1, wherein an inner surface of the sheath is lined with PTFE.

7. The transseptal access sheath of claim 1, wherein the thickness of the sheath varies from the proximal end to the distal end.

8. The transseptal access sheath of claim 1, wherein the thickness of the sheath decreases in discrete stages from the proximal end to the distal end.

9. The transseptal access sheath of claim 1, wherein the thickness of the sheath decreases gradually from the proximal end to the distal end.

10. The transseptal access sheath of claim 1, wherein the thickness of the sheath decreases gradually and continuously from the proximal end to the distal end.

11. The transseptal access sheath of claim 1, comprising a radiopaque marking band toward the distal end.

12. The transseptal access sheath of claim 1, comprising a radiopaque marking band toward the distal end and with vent holes in the marking band.

15. The transseptal access system of claim 14, wherein the dilator is an inflatable balloon.

16. The transseptal access system of claim 14, wherein the dilator has a spiral helical structure.

17. The transseptal access system of claim 14, wherein the dilator is coated with PTFE.

18. The transseptal access system of claim 14, wherein the dilator comprises a vacuum lumen to allow application of a vacuum to the fossa ovalis.

19. The transseptal access system of claim 14, wherein the dilator includes at least one infusion port for infusing saline solution.

20. The transseptal access system of claim 14, wherein the sheath comprises a vacuum lumen to allow application of a vacuum to the fossa ovalis.

21. The transseptal access system of claim 14, wherein the needle is coated with PTFE.

22. The transseptal access system of claim 14, wherein the needle has a spiral helical structure.

23. The transseptal access system of claim 14, further comprising an ultrasound transducer for oscillating the needle at ultrasonic frequencies.

24. The transseptal access system of claim 14, wherein the needle has at least one expandable cutting surface.

25. The transseptal access system of claim 14, wherein at least one additional cutting surface of the needle is exposed to make an opening in the fossa ovalis upon proximal retraction of the needle through the fossa ovalis that is larger than the opening in the fossa ovalis made upon initial distal advancement of the needle through the fossa ovalis.

26. The transseptal access system of claim 14, wherein the needle is advanced by biasing means.

27. The transseptal access system of claim 14, wherein at least a portion of the sheath and the dilator are covered in a PTFE jacket.

13. A transseptal access sheath comprising;

a first curved section, and a second curved section;

wherein the first curved section is shaped to abut the interior wall of the right atrium substantially opposite the fossa ovalis while directing the distal tip toward the fossa ovalis; and

,

wherein the second curved section is shaped to facilitate location and access into the LAA.

14. A transseptal access system comprising a sheath, a dilator and a needle;

wherein the sheath comprises;

a first curved section, and a second curved section;

the first curved section having an outer edge that defines

a first proximal edge point, and

a first distal edge point

wherein the intersection between a tangent drawn to the first curved section at the first proximal edge point and a tangent drawn to the first curved section at the first distal edge point, define a first angle and a first plane;

the second curved section having an outer edge that defines

a second proximal edge point, and

a second distal edge point

wherein the intersection between a tangent drawn to the second curved section at the second proximal edge point and a tangent drawn to the second curved section at the second distal edge point, define a second angle and a second plane;

wherein the first angle is within the range of about 75 degrees to about 105 degrees;

wherein the second angle is within the range of about 75 degrees to about 105 degrees; and

wherein the angle between the first and second plane is within the range of about 75 degrees to about 105 degrees.