DEVICES, SYSTEMS, AND METHODS FOR ACCESSING CARDIAC TISSUE

• US 20100256599A1
• Filed: 06/16/2010
• Published: 10/07/2010
• Est. Priority Date: 06/30/2006
• Status: Active Grant

• Current Assignee: CVDEVICES, LLC
• Original Assignee: CVDEVICES, LLC
• Inventors: Navia, Jose A. SR., Kassab, Ghassan S.
• Granted Patent: US 8,894,606 B2
• Time in Patent Office: Days
• US Class Current: 604/508
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61N 1/0592 Introducing the lead through the pericardium with a needle

Abstract

Devices, systems, and methods for accessing the internal and external tissues of the heart are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for localized delivery of substances to the heart tissue. In addition, various disclosed embodiments provide access to the internal surface of the heart for aspiration and delivery of substances to a targeted region without disturbing or interfering with nearby structures or surfaces.

Claims

1. A system for engaging heart tissue, comprising:

an engagement catheter, comprising;

a proximal end, a distal end, and first and second lumens extending between the proximal end and the distal end;

a vacuum port located at or near the proximal end of the engagement catheter, the vacuum port operatively connected to the first lumen of the engagement catheter and capable of operative connection to a vacuum source; and

a suction port located at or near the distal end of the engagement catheter in communication with the first lumen of the engagement catheter, the suction port configured to removably engage a targeted tissue on an interior of a wall of a heart, such that the suction port is capable of forming a reversible seal with the wall of the heart when the vacuum source is operatively attached to the vacuum port; and

a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the hollow tube is capable of insertion into the second lumen of the engagement catheter.

2. The system of claim 1, wherein the system is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds the heart by retracting the targeted tissue away from the pericardial sac.

3. The system of claim 1, wherein the suction port is configured to removably engage a portion of an atrial wall, an atrial appendage, a right atrial wall, or a right atrial appendage.

4. The system of claim 1, wherein the delivery catheter further comprises a needle located at the distal end of the delivery catheter.

5. The system of claim 4, wherein the needle is capable of piercing the targeted tissue when the delivery catheter is inserted into the second lumen and the suction port engages the targeted tissue.

6. The system of claim 4, wherein the needle comprises a needle wire for piercing the targeted tissue.

7. The system of claim 4, wherein the needle comprises a pressure tip needle.

8. The system of claim 4, further comprising:

a guide wire for insertion into the pericardial space.

9. The system of claim 8, wherein the needle comprises a hollow needle in communication with the delivery catheter, and wherein the guide wire is capable of insertion through the delivery catheter and the hollow needle into the pericardial space.

10. The system catheter of claim 1, wherein when the engagement catheter is used to removably engage the targeted tissue, the delivery catheter may be inserted into and/or removed from the second lumen of the engagement catheter.

11. The system catheter of claim 1, wherein the first and second lumens are defined by an outer wall and an inner wall of the engagement catheter.

12. The system of claim 10, further comprising:

at least one internal lumen support positioned within the first lumen and attached to the outer wall and the inner wall, the at least one internal lumen support extending from the distal end of the engagement catheter along at least part of a length of the engagement catheter.

13. The system of claim 12, wherein the at least one internal lumen support comprises two internal lumen supports, wherein the two lumen supports define a third lumen.

14. The system of claim 1, wherein the engagement catheter further comprises an injection channel in fluid communication with the second lumen of the engagement catheter, the injection channel configured to administer a fluid to the targeted tissue.

15. The system of claim 1, wherein the engagement catheter further comprises an injection channel in fluid communication with the second lumen of the engagement catheter, the injection channel configured to administer an adhesive to the targeted tissue.

16. The system of claim 14, wherein the injection channel is ring-shaped.

17. The system of claim 1, wherein the engagement catheter further comprises an injection channel formed along the length of the engagement catheter, the injection channel having at its distal end at least one opening for administering a fluid to the targeted tissue, the injection channel capable of operable attachment to an external fluid source at the proximal end of the injection channel, such that fluid from the external fluid source can flow through the injection channel to the targeted tissue when the external fluid source is operatively attached to the injection channel.

18. An engagement catheter for engaging heart tissue, comprising:

an elongated tube comprising a proximal end, a distal end, an outer wall positioned circumferentially along the length of the tube, and an inner wall positioned circumferentially along the length of the tube, wherein the outer wall and the inner wall form at least one suction channel along the length of the tube, and wherein the inner wall defines an internal lumen;

a vacuum port in communication with the proximal end of the tube, the vacuum port operatively connected to the at least one suction channel and capable of operative connection to a vacuum source; and

a suction port in communication with the at least one suction channel at or near the distal end of the tube, the suction port configured to removably engage a targeted tissue on the interior of a wall of a heart, such that the suction port is capable of forming a reversible seal with the wall of the heart when the vacuum source is operatively attached to the vacuum port.

19. The engagement catheter of claim 18, wherein when the engagement catheter is used to removably engage the targeted tissue, a delivery catheter may be inserted into and/or removed from the internal lumen of the engagement catheter.

20. The engagement catheter of claim 18, wherein the engagement catheter is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds the heart by retracting the targeted tissue away from the pericardial sac.

21. The engagement catheter of claim 18, wherein the suction port is configured to removably engage a portion of an atrial wall, an atrial appendage, a right atrial wall, or a right atrial appendage.

22. The engagement catheter of claim 18, further comprising:

at least one internal lumen support positioned within the at least one suction channel and attached to the outer wall and the inner wall, the at least one internal lumen support extending from the distal end of the tube along at least part of a length of the tube.

23. The engagement catheter of claim 22, wherein the at least one internal lumen support comprises two internal lumen supports and the at least one suction channel comprises two suction channels.

24. The engagement catheter of claim 18, further comprising:

an injection channel formed along the length of the tube, the injection channel having at its distal end at least one opening for administering a fluid to the targeted tissue, the injection channel capable of operable attachment to an external fluid source at the proximal end of the injection channel, such that fluid from the external fluid source can flow through the injection channel to the targeted tissue when the external fluid source is operatively attached to the injection channel.

25. A method of accessing a pericardial space surrounding a heart, the method comprising the steps of:

inserting an engagement catheter into a mammalian body such that a distal end of the engagement catheter is positioned inside a heart and a suction port of the engagement catheter is in contact with a targeted tissue on the interior of a wall of the heart;

operating a vacuum source coupled to a vacuum port of the engagement catheter so that the suction port removably engages the targeted tissue;

inserting a delivery catheter into a lumen of the engagement catheter; and

piercing the targeted tissue on the interior of the wall of the heart with a needle of the delivery catheter to provide access to a pericardial space surrounding the heart.

26. The method of claim 25, further comprising the step of:

administering a substance into the pericardial space using the delivery catheter.

27. The method of claim 25, further comprising the steps of:

withdrawing the needle from the targeted tissue; and

administering a substance to the targeted tissue using the delivery catheter after withdrawing the needle.

28. The method of claim 27, wherein the step of administering a substance comprises administering an adhesive for sealing a hold in the targeted tissue created by the needle.

29. The method of claim 25, wherein the step of operating a vacuum source is performed so that the suction port removably engages a portion of an atrial wall, an atrial appendage, a right atrial wall, or a right atrial appendage.

30. The method of claim 25, further comprising the step of:

accessing the pericardial space by inserting at least a distal end of a guide wire through the wall of the heart into the pericardial space.

31. The method of claim 30, further comprising the step of:

advancing at least part of a delivery catheter over the guide wire and into the pericardial space.

32. A method of engaging heart tissue, the method comprising:

extending into a blood vessel an elongated tube having a proximal end, a distal end, and at least one lumen, such that the distal end of the tube is in contact with a targeted tissue on the interior of a wall of the heart; and

aspirating the targeted tissue such that the wall of the heart is retracted away from a pericardial sac surrounding the heart to enlarge a pericardial space between the pericardial sac and the wall of the heart.

33. The method of claim 32, further comprising the steps of:

delivering a fluid onto the targeted tissue; and

removing the elongated tube from the body.

34. The method of claim 32, wherein the step of aspirating the targeted tissue comprises aspirating an atrial wall or an atrial appendage to retract the atrial wall or the atrial appendage away from the pericardial sac.

35. The method of claim 32, wherein the step of aspirating the targeted tissue further comprises pulling back the elongated tube to retract the wall of the heart to enlarge the pericardial space.

36. The method of claim 32, further comprising the steps of:

inserting through one of the at least one lumen of the elongated tube a delivery catheter having a proximal end, a distal end, and a needle located at the distal end, such that the needle is located within the heart; and

inserting the needle into the targeted tissue to puncture the targeted tissue.

37. The method of claim 36, further comprising the step of:

injecting a fluid into the pericardial space such that the fluid contacts the exterior of the heart within the pericardial space.

38. The method of claim 36, further comprising the steps of:

inserting at least the distal end of an elongated guide wire through the needle into the pericardial space; and

advancing at least part of the delivery catheter into the pericardial space.