Devices, systems, and methods for accessing cardiac tissue

• US 8,894,606 B2
• Filed: 06/16/2010
• Issued: 11/25/2014
• Est. Priority Date: 06/30/2006
• Status: Active Grant

• Current Assignee: CVDEVICES, LLC
• Original Assignee: CVDEVICES, LLC
• Inventors: Kassab, Ghassan S., Navia, Jose A. Sr.
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US12/816,655
• Publication Number:
  US 20100256599A1
• Time in Patent Office: 1,623 Days
• Field of Search: 604/35, 604/161, 604/164.01, 604/198, 604/192, 604/162
• US Class Current: 604/35
• 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 a first lumen 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 through the vacuum port into the first lumen of the engagement catheter while the reversible seal is maintained under vacuum through the first lumen using the suction port;

wherein the engagement catheter is configured for percutaneous intravascular insertion into a patient through a blood vessel of the patient and further configured for advancement to the targeted tissue through the blood vessel;

wherein the suction port is configured to removably attach to the targeted tissue after introduction of a portion of the system into the blood vessel; and

wherein the engagement catheter is configured so that at least a portion of the engagement catheter can be retracted after percutaneous intravascular insertion, while remaining removably attached to the targeted tissue, due to vacuum from the vacuum source through the first lumen of the engagement catheter and suction engagement from the suction port, so to locally increase a distance between the targeted tissue and a pericardium surrounding the heart.

2. 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.

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

4. The system of claim 3, wherein the needle is capable of piercing the targeted tissue when the delivery catheter is inserted into the first lumen and the suction port engages the targeted tissue.

5. The system of claim 3, wherein the needle comprises a needle wire for piercing the targeted tissue.

6. The system of claim 3, wherein the needle comprises a pressure tip needle.

7. The system of claim 3, further comprising:

a guide wire for insertion into a pericardial space.

8. The system of claim 7, 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.

9. The system 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 first lumen of the engagement catheter.

10. The system of claim 1, wherein the engagement catheter further defines a second lumen extending between the proximal end and the distal end and wherein the first and second lumens are defined by an outer wall and an inner wall of the engagement catheter.

11. 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.

12. The system of claim 11, wherein the at least one internal lumen support comprises two internal lumen supports, wherein the two lumen supports define a third lumen.

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

14. The system of claim 13, wherein the injection channel is ring-shaped.

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

16. 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.

17. A system, comprising:

an engagement catheter for engaging heart tissue, comprising;

an elongated tube comprising a proximal end, a distal end, and an internal lumen extending between the proximal end and the distal end;

a vacuum port in communication with the proximal end of the tube, the vacuum port operatively connected to the internal lumen and capable of operative connection to a vacuum source; and

a suction port in communication with the internal lumen 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;

wherein the engagement catheter is configured for percutaneous intravascular insertion into a patient through a blood vessel of the patient and further configured for advancement to the targeted tissue through the blood vessel;

wherein the suction port is configured to removably attach to the targeted tissue under vacuum applied from the vacuum source after introduction of a portion of the engagement catheter into the blood vessel; and

wherein the engagement catheter is configured so that at least a portion of the engagement catheter can be retracted after percutaneous intravascular insertion, while remaining removably attached to the targeted tissue due to vacuum from the vacuum source through the first lumen of the engagement catheter and suction engagement from the suction port, so to locally increase a distance between the targeted tissue and a pericardium surrounding the heart; and

a second device;

wherein the engagement catheter is configured so that when the engagement catheter is used to form the reversible seal under vacuum through the first lumen using the suction port, the second device can be delivered through the vacuum port into the first lumen of the engagement catheter while maintaining the reversible seal.

18. The system of claim 17, 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.

19. The system of claim 17, 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.

20. The system of claim 17, further comprising:

at least one internal lumen support positioned within the internal lumen and attached to the tube, 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.

21. The system of claim 20, wherein the internal lumen comprises two internal lumens.

22. The system of claim 17, 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.

23. The system of claim 17, wherein the engagement catheter further comprises a needle located within the internal lumen of the engagement catheter, and wherein the needle is capable of piercing the targeted tissue when the suction port engages the targeted tissue.

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

inserting at least a portion of an engagement catheter into a mammalian body, the engagement catheter comprising;

a proximal end, a distal end, and a first lumen 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,

wherein the engagement catheter is configured for percutaneous intravascular insertion into a patient through a blood vessel of the patient and further configured for advancement to the targeted tissue through the blood vessel,

wherein the suction port is configured to removably attach to the targeted tissue under vacuum applied from the vacuum source after introduction of the at least a portion of the engagement catheter into the blood vessel,

wherein the engagement catheter is configured so that at least a portion of the engagement catheter can be retracted after percutaneous intravascular insertion, while remaining removably attached to the targeted tissue due to vacuum from the vacuum source through the first lumen of the engagement catheter and suction engagement from the suction port, so to locally increase a distance between the targeted tissue and a pericardium surrounding the heart, and

wherein the engagement catheter is configured so that when the engagement catheter is used to form the reversible seal under vacuum through the first lumen using the suction port, a second device can be delivered through the vacuum port into the first lumen of the engagement catheter while maintaining the reversible seal;

positioning the distal end of the engagement catheter such that the suction port of the engagement catheter is in contact with the targeted tissue on the interior of a wall of the heart;

operating the vacuum source so that the suction port removably engages the targeted tissue, forming the reversible seal;

retracting at least a portion of the engagement catheter, while remaining removably attached to the targeted tissue under vacuum, so to locally increase the distance between the targeted tissue and the pericardium; and

after forming the reversible seal, delivering the second device through the vacuum port into the first lumen of the engagement catheter while maintaining the reversible seal.

25. The method of claim 24, further comprising the steps of:

piercing the targeted tissue on the interior of the wall of the heart, using a needle positioned within the internal lumen of the engagement catheter, to provide access to a pericardial space; and

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

26. The method of claim 24, further comprising the steps of:

piercing the targeted tissue on the interior of the wall of the heart, using a needle positioned within the internal lumen of the engagement catheter, to provide access to a pericardial space;

withdrawing the needle from the targeted tissue; and

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

27. The method of claim 26, wherein the step of administering a substance comprises administering an adhesive for sealing a hole in the targeted tissue created by the needle.

28. The method of claim 24, 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.

29. The method of claim 24, further comprising the step of:

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

30. The method of claim 29, further comprising the step of:

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

31. The method of claim 24, wherein the vacuum from the vacuum source is sufficient to permit performance of the step of retraction, and wherein the engagement catheter is configured so not to collapse due to the vacuum from the vacuum source.

32. The method of claim 24, further comprising the steps of:

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

piercing the targeted tissue on the interior of the wall of the heart with a needle positioned within or at the distal end of the delivery catheter to provide access to a pericardial space surrounding the heart.

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

extending into a blood vessel at least a portion of an engagement catheter, the engagement catheter comprising;

an elongated tube comprising a proximal end, a distal end, and an internal lumen extending between the proximal end and the distal end;

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;

wherein the engagement catheter is configured for percutaneous intravascular insertion into a patient through a blood vessel of the patient and further configured for advancement to the targeted tissue through the blood vessel;

wherein the suction port is configured to removably attach to the targeted tissue after introduction of the at least a portion of the engagement catheter into the blood vessel; and

wherein the engagement catheter is configured so that at least a portion of the engagement catheter can be retracted after percutaneous intravascular insertion, while remaining removably attached to the targeted tissue due to vacuum from the vacuum source through the first lumen of the engagement catheter and suction engagement from the suction port, so to locally increase a distance between the targeted tissue and a pericardium surrounding the heart, and

wherein the engagement catheter is configured so that when the engagement catheter is used to form the reversible seal under vacuum through the first lumen using the suction port, a second device can be delivered through the vacuum port into the first lumen of the engagement catheter while maintaining the reversible seal;

positioning the distal end of the engagement catheter in contact with a targeted tissue on the interior of a wall of the heart; and

aspirating the targeted tissue so to removably engage the targeted tissue under vacuum, forming the reversible seal;

retracting at least a portion of the engagement catheter, while remaining removably attached to the targeted tissue under vacuum, so to increase the distance between the targeted tissue and the pericardium; and

after forming the reversible seal, delivering the second device through the vacuum port into the first lumen of the engagement catheter while maintaining the reversible seal.

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

delivering a fluid onto the targeted tissue; and

removing the elongated tube from the body.

35. The method of claim 33, wherein the step of aspirating the targeted tissue comprises aspirating an atrial wall or an atrial appendage.

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

inserting through the internal lumen of the elongated tube a delivery catheter having a proximal end, a distal end, and a needle located within or at the distal end of the delivery catheter; 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 a pericardial space such that the fluid contacts an epicardial surface 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 a pericardial space; and

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