Methods and devices for transseptal access

• US 20060009737A1
• Filed: 07/12/2004
• Published: 01/12/2006
• Est. Priority Date: 07/12/2004
• Status: Active Grant

• Current Assignee: Savacor, Inc. (Abbott Laboratories)
• Original Assignee: Savacor, Inc. (Abbott Laboratories)
• Inventors: Whiting, James S., Eigler, Neal
• Granted Patent: US 7,678,081 B2
• Time in Patent Office: Days
• US Class Current: 604/135
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

Systems and methods for penetrating a tissue membrane to gain access to a target site are disclosed. In some examples, systems and methods for accessing the left atrium from the right atrium of a patient'"'"'s heart are carried out by puncturing the intra-atrial septal wall. One embodiment provides a system for transseptal cardiac access that includes a guiding catheter, an access catheter and a guidewire. The access catheter may include a tissue penetration member disposed within a housing wherein the tissue penetration member is substantially contained within the housing when in a retracted configuration. When the distal end of the access catheter is disposed adjacent the septal wall, the user can initiate an actuator switch, which may be in a proximal portion of the system, to cause the tissue penetration member to extend through the septal wall. Alternatively, the tissue penetration member can be actuated automatically by a contact trigger mechanism, without initiation by the user, upon contact with the septal wall by a distal contact member which is coupled to the contact trigger mechanism. Such a system may also include an interlock mechanism to prevent triggering of the tissue penetration member at undesirable times during a procedure.

Claims

1. A transseptal access system, comprising

an elongate guiding catheter having a proximal end, a distal end and an inner lumen extending from the proximal end to the distal end thereof;

an access catheter disposed within the inner lumen of the guiding catheter having an elongate catheter body section with a proximal end, a distal end and a distal section, a body section guidewire lumen disposed along the elongate catheter body section and a tissue penetration member having a guidewire lumen in fluid communication with the body section guidewire lumen disposed at the distal section of the elongate catheter body section and axially displaceable in a distal direction with respect to the distal section of the elongate catheter body section;

a tissue penetration actuator configured to impart force in a distal direction on the tissue penetration member; and

a guidewire configured and sized to be slidably disposed within the body section guidewire lumen and the guidewire lumen of the tissue penetration member.

2. The access system of claim 1 wherein the distal section of the elongate catheter body section further comprises a housing having a translation chamber bounded at least partially by an inner bore, the tissue penetration member further comprises a piston slidably sealed against the inner bore of the housing, the elongate catheter body section further comprises an actuation lumen in communication with the translation chamber and wherein the tissue penetration actuator comprises a pressurized fluid actuator in fluid communication with the actuation lumen of the elongate catheter body section.

3. The access system of claim 2 wherein the pressurized fluid actuator comprises a syringe actuated by a compressed spring.

4. The access system of claim 2 wherein the piston is configured to be sealed against and slidingly disposed in relation to an outer surface of a distal portion of the body section guidewire lumen.

5. The access system of claim 2 wherein a distal portion of the body section guidewire lumen is secured to the tissue penetration member and wherein the body section guidewire lumen and tissue penetration member move together axially upon actuation of the tissue penetration member.

6. The access system of claim 2 further comprising a resilient rebound member disposed in the translation chamber between a distal end of the piston and a distal boundary of the translation chamber.

7. The access system of claim 6 wherein the resilient rebound member extends from the piston to the distal boundary of the translation chamber and exerts a proximally directed force on the piston when the tissue penetration member is in a fully retracted state so as to fully retract the tissue penetration member when the tissue penetration actuator is not actuated.

8. The access system of claim 1 further comprising an interlock mechanism configured to prevent distal translation of the tissue penetration member when in a locked state and allow distal translation of the tissue penetration member when in an unlocked state.

9. The access system of claim 8 further comprising a distal contact member extending from the distal end of the access catheter and coupled to a contact trigger mechanism which is configured to prevent distal translation of the tissue penetration member when in a locked state and allow distal translation of the tissue penetration member when in an unlocked state whereby the contact trigger mechanism is unlocked upon contact with target tissue of the septum by the distal contact member.

10. The access system of claim 8 further comprising a proximal interlock switch coupled to the interlock mechanism and whereby the interlock mechanism is unlocked by an operator by operation of the interlock switch at a proximal end of the access catheter.

11. The access system of claim 1 wherein the tissue penetration actuator comprises a spring configured to exert a distally directed force on the tissue penetration member when released from a compressed state.

12. The access system of claim 11 wherein the spring comprises a compressible spring in a compressed state disposed proximally of the tissue penetration member prior to actuation.

13. The access system of claim 1 wherein the tissue penetration actuator comprises a spring configured to exert a distally directed force on the tissue penetration member when released from an expanded state.

14. The access system of claim 1 wherein the tissue penetration actuator comprises a mechanical actuator disposed at a proximal portion of the access catheter and is coupled to the tissue penetration member by an elongate actuation shaft whereby distal force from the tissue penetration actuator is transferred to the tissue penetration member by the elongate actuation shaft upon actuation.

15. The access system of claim 14 wherein the elongate actuation shaft comprises the body section guidewire lumen, a distal portion of the body section guidewire lumen is secured to the tissue penetration member and the body section guidewire lumen and tissue penetration member move together axially upon actuation of the tissue penetration member.

16. The access system of claim 1 wherein the tissue penetration member comprises a hypodermic needle having a sharpened tissue penetrating tip.

17. The access system of claim 16 wherein the hypodermic needle has a length of about 0.5 cm to about 10 cm.

18. The access system of claim 16 wherein access catheter is configured such that the hypodermic needle extends about 0.25 cm to about 2 cm from the distal end of the access catheter when at full distal extension after actuation.

19. An access catheter, comprising

an elongate catheter body section with a proximal end, a distal end and a distal section;

a body section guidewire lumen disposed along the elongate catheter body section;

a tissue penetration member having a guidewire lumen in fluid communication with the body section guidewire lumen disposed at the distal section of the elongate catheter body section; and

a tissue penetration actuator coupled to the tissue penetration member.

20. The access catheter of claim 19 wherein the distal section of the elongate catheter body section further comprises a housing having a translation chamber bounded at least partially by an inner bore, the tissue penetration member further comprises a piston slidably sealed against the inner bore of the housing, the elongate catheter body section further comprises an actuation lumen in communication with the translation chamber and wherein the tissue penetration actuator comprises a pressurized fluid actuator in fluid communication with the actuation lumen of the elongate catheter body section.

21. The access catheter of claim 20 wherein the pressurized fluid actuator comprises a syringe actuated by a compressed spring.

22. The access catheter of claim 20 wherein the piston is configured to be sealed against and slidingly disposed in relation to an outer surface of a distal portion of the body section guidewire lumen.

23. The access catheter of claim 20 wherein a distal portion of the body section guidewire lumen is secured to the tissue penetration member and wherein the body section guidewire lumen and tissue penetration member move together axially upon actuation of the tissue penetration member.

24. The access catheter of claim 20 further comprising a resilient rebound member disposed in the translation chamber between a distal end of the piston and a distal boundary of the translation chamber.

25. The access catheter of claim 24 wherein the resilient rebound member extends from the piston to the distal boundary of the translation chamber and exerts a proximally directed force on the piston when the tissue penetration member is in a fully retracted state so as to fully retract the tissue penetration member when the tissue penetration actuator is not actuated.

26. The access catheter of claim 19 further comprising an interlock mechanism configured to prevent distal translation of the tissue penetration member when in a locked state and allow distal translation of the tissue penetration member when in an unlocked state.

27. The access catheter of claim 26 further comprising a distal contact member extending from the distal end of the access catheter and coupled to a contact trigger mechanism which is configured to prevent distal translation of the tissue penetration member when in a locked state and allow distal translation of the tissue penetration member when in an unlocked state whereby the contact trigger mechanism is unlocked upon contact with target tissue of the septum by the distal contact member.

28. The access catheter of claim 26 further comprising a proximal interlock switch coupled to the interlock mechanism and whereby the interlock mechanism is unlocked by an operator by operation of the interlock switch at a proximal end of the access catheter.

29. The access catheter of claim 19 wherein the tissue penetration actuator comprises a spring configured to exert a distally directed force on the tissue penetration member when released from a compressed state.

30. The access catheter of claim 29 wherein the spring comprises a compressible spring in a compressed state disposed proximally of the tissue penetration member prior to actuation.

31. The access catheter of claim 19 wherein the tissue penetration actuator comprises a spring configured to exert a distally directed force on the tissue penetration member when released from an expanded state.

32. The access catheter of claim 19 wherein the tissue penetration actuator comprises a mechanical actuator disposed at a proximal portion of the access catheter and is coupled to the tissue penetration member by an elongate actuation shaft whereby distal force from the tissue penetration actuator is transferred to the tissue penetration member by the elongate actuation shaft upon actuation.

33. The access catheter of claim 32 wherein the elongate actuation shaft comprises the body section guidewire lumen, a distal portion of the body section guidewire lumen is secured to the tissue penetration member and the body section guidewire lumen and tissue penetration member move together axially upon actuation of the tissue penetration member.

34. The access catheter of claim 19 wherein the tissue penetration member comprises a hypodermic needle having a sharpened tissue penetrating tip.

35. The access catheter of claim 34 wherein the hypodermic needle has a length of about 0.5 cm to about 10 cm.

36. The access catheter of claim 34 wherein access catheter is configured such that the hypodermic needle extends about 0.25 cm to about 2 cm from the distal end of the access catheter when at full distal extension after actuation.

37. A method of accessing the left atrium of a patient'"'"'s heart from the right atrium of the patient'"'"'s heart, comprising

providing a system for transseptal access, including

a guiding catheter having an inner lumen extending along a length thereof,

an access catheter disposed within the inner lumen of the guiding catheter having an elongate catheter body section with a proximal end, a distal end and a distal section, a body section guidewire lumen disposed along the elongate catheter body section and a tissue penetration member having a guidewire lumen in fluid communication with the body section guidewire lumen disposed at the distal section of the elongate catheter body section,

a tissue penetration actuator coupled to the tissue penetration member and configured to rapidly advance the tissue penetration member distally upon actuation, and

a guidewire configured and sized to be slidably disposed within the body section guidewire lumen and the guidewire lumen of the tissue penetration member;

positioning the guiding catheter with the distal end of the guiding catheter within the right atrium of the patient'"'"'s heart;

advancing the distal end of the access catheter through the inner lumen of the guiding catheter until the distal end of the access catheter is positioned adjacent a desired site of the septum of the patient'"'"'s heart;

activating the tissue penetration actuator and advancing the tissue penetration member distally through the septum; and

advancing the guidewire through the guidewire lumen of the tissue penetration member until a distal end of the guidewire is disposed within the left atrium of the patient'"'"'s heart.

38. The method of claim 37 further comprising removing the access catheter from the patient'"'"'s body while maintaining the guidewire in place with a distal portion of the guidewire located in the left atrium.

39. The method of claim 37 wherein the distal section of the elongate catheter body section further comprises a housing having a translation chamber bounded at least partially by an inner bore, the tissue penetration member further comprises a piston slidably sealed against the inner bore of the housing, the elongate catheter body section further comprises an actuation lumen in communication with the translation chamber, the tissue penetration actuator comprises a pressurized fluid actuator in fluid communication with the actuation lumen of the elongate catheter body section and wherein the tissue penetration member is advanced by expulsion of pressurized fluid from the pressurized fluid actuator which travels through the actuation lumen, enters the translation chamber and exerts pressurized force against the piston.

40. The method of claim 37 wherein the tissue penetration actuator comprises a spring configured to exert a distally directed force on the tissue penetration member when released from a compressed state and actuation of the tissue penetration member comprises releasing the spring from a compressed state.

41. The method of claim 37 wherein the tissue penetration actuator comprises a spring configured to exert a distally directed force on the tissue penetration member when released from an expanded state and actuation of the tissue penetration member comprises releasing the spring from an expanded state.

42. The method of claim 37 wherein the tissue penetration actuator comprises a mechanical actuator disposed at a proximal portion of the access catheter and is coupled to the tissue penetration member by an elongate actuation shaft whereby distal force from the tissue penetration actuator is transferred to the tissue penetration member by the elongate actuation shaft upon actuation.

43. The method of claim 37 wherein the elongate actuation shaft comprises the body section guidewire lumen, a distal portion of the body section guidewire lumen is secured to the tissue penetration member and the body section guidewire lumen and tissue penetration member move together axially upon actuation of the tissue penetration member.

44. A method of accessing a second side of a tissue membrane from a first side of a tissue membrane, comprising

providing an access catheter, having

an elongate catheter body section with a proximal end, a distal end and a distal section,

a body section guidewire lumen disposed along the elongate catheter body section, and

a tissue penetration member having a guidewire lumen in fluid communication with the body section guidewire lumen disposed at the distal section of the elongate catheter body section, and

a tissue penetration actuator coupled to the tissue penetration member and configured to rapidly advance the tissue penetration member distally upon actuation;

positioning the distal end of the access catheter until the distal end of the access catheter is positioned adjacent a desired site on the first side of the tissue membrane;

activating the tissue penetration actuator and advancing the tissue penetration member distally through the tissue membrane; and

advancing a guidewire through the body section guidewire lumen and guidewire lumen of the tissue penetration member until a distal end of the guidewire is disposed on the second side of the tissue membrane.

45. The method of claim 44 further comprising removing the access catheter from the patient'"'"'s body while maintaining the guidewire in place with a distal portion of the guidewire located in place.

46. The method of claim 44 wherein the distal section of the elongate catheter body section further comprises a housing having a translation chamber bounded at least partially by an inner bore, the tissue penetration member further comprises a piston slidably sealed against the inner bore of the housing, the elongate catheter body section further comprises an actuation lumen in communication with the translation chamber, the tissue penetration actuator comprises a pressurized fluid actuator in fluid communication with the actuation lumen of the elongate catheter body section and wherein the tissue penetration member is advanced by expulsion of pressurized fluid from the pressurized fluid actuator which travels through the actuation lumen, enters the translation chamber and exerts pressurized force against the piston.

47. The method of claim 44 wherein the tissue penetration actuator comprises a spring configured to exert a distally directed force on the tissue penetration member when released from a compressed state and actuation of the tissue penetration member comprises releasing the spring from a compressed state.

48. The method of claim 44 wherein the tissue penetration actuator comprises a spring configured to exert a distally directed force on the tissue penetration member when released from an expanded state and actuation of the tissue penetration member comprises releasing the spring from an expanded state.

49. The method of claim 44 wherein the tissue penetration actuator comprises a mechanical actuator disposed at a proximal portion of the access catheter and is coupled to the tissue penetration member by an elongate actuation shaft whereby distal force from the tissue penetration actuator is transferred to the tissue penetration member by the elongate actuation shaft upon actuation.

50. The method of claim 49 wherein the elongate actuation shaft comprises the body section guidewire lumen, a distal portion of the body section guidewire lumen is secured to the tissue penetration member and the body section guidewire lumen and tissue penetration member move together axially upon actuation of the tissue penetration member.