Devices, systems, and methods for pericardial access

• US 8,075,532 B2
• Filed: 03/12/2008
• Issued: 12/13/2011
• 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): Lucchesi, Nicholas D
• Assistant Examiner(s): Price, Nathan R
• Application Number:
  US12/596,968
• Publication Number:
  US 20100160719A1
• Time in Patent Office: 1,371 Days
• Field of Search: 604/103.07, 604/104, 604/164.01, 604/164.03, 604/164.04, 604/164.08, 604/164.13, 604/174, 604/176, 604/511, 607/120, 607/122, 607/126, 607/129, 607/130
• US Class Current: 604/176
• 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 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00584 Clips
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• 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 2017/00628 T-shaped occluders
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 2205/33 : Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2210/122 : Pericardium
• CPC Class Codes: A61M 2210/125 : Heart
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 25/00 : Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/003 : characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0084 : being one or more injection needles
• CPC Class Codes: A61M 25/0136 : Handles therefor
• CPC Class Codes: A61M 25/0141 : having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/06 : Body-piercing guide needles or the like
• CPC Class Codes: A61M 60/191 : mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
• CPC Class Codes: A61M 60/289 : Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/468 : the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/508 : Electronic control means, e.g. for feedback regulation
• CPC Class Codes: A61M 60/865 : Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: A61N 1/0587 : Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

Devices, systems, and methods for accessing tissue, including 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 leads to the heart tissue. At least some of the embodiments disclosed herein provide access to the pericardial space for removal of accumulated fluid. In addition, various disclosed embodiments provide devices, systems, and methods for engaging a tissue, for removing fluid from a space within a body, and for the delivery of substances to a targeted site for therapeutic purposes.

Claims

1. A system for use with a vacuum source for engaging a tissue, the system comprising:

an engagement catheter comprising a proximal end, a distal end, first and second lumens extending between the proximal end and the distal end, an injection channel formed along a length of the engagement catheter, the injection channel being ring-shaped at its distal end and having at its distal end at least one opening for administering a substance to a targeted tissue, and a skirt operatively connected to the distal end, the skirt comprising a proximal end having a circumference substantially similar to an outer circumference of the engagement catheter, the skirt further comprising a distal end having a circumference larger than the outer circumference of the engagement catheter;

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;

a needle located at the distal end of the delivery catheter; and

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

wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to allow the distal end of the skirt to removably engage a surface of a bodily tissue such that the skirt is capable of forming a reversible seal with the surface of the tissue when a vacuum source is operatively attached to the vacuum port.

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

3. The system of claim 1, wherein the tissue engaged by the system is a heart.

4. The system of claim 3, wherein the system is capable of enlarging a pericardial space between the heart and a pericardial sac when the skirt is attached to an interior wall of the heart.

5. The system of claim 1, wherein the skirt comprises a deformable configuration, and wherein the deformable configuration of the skirt is capable of expanding to an expanded configuration.

6. The system of claim 1, further comprising a sleeve comprising a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, wherein the sleeve is positioned around the engagement catheter, wherein the sleeve slidingly engages the engagement catheter.

7. The system of claim 6, wherein the sleeve may be positioned at the distal end of the engagement catheter, and wherein the sleeve at least partially surrounds the skirt.

8. The system of claim 7, wherein the deformable configuration of the skirt is collapsed when at least partially surrounded by the sleeve.

9. The system of claim 6, wherein the sleeve is positioned along the engagement catheter so not to surround the skirt, wherein the skirt is capable of expanding to an expanded configuration.

10. The system of claim 1, wherein the needle is positioned to be capable of piercing the targeted tissue when the hollow tube is inserted into the second lumen and the suction port is attached to the targeted tissue, such that, when the targeted tissue is pierced, access to the pericardial space is achieved.

11. The system of claim 2, further comprising a guide wire for insertion into the pericardial space, wherein the needle comprises a hollow needle in communication with the hollow tube, and wherein the guide wire is capable of insertion through the hollow tube and the hollow needle into the pericardial space.

12. The system of claim 1, wherein the engagement catheter the injection channel is in fluid communication with the second lumen of the engagement catheter.

13. The system of claim 1, wherein the substance comprises an adhesive.

14. The system of claim 1, wherein the injection channel is 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.

15. The system of claim 1, wherein the needle comprises a needle wire for piercing the targeted tissue.

16. The system of claim 1, wherein the needle comprises a pressure tip needle.

17. The system of claim 1, wherein the engagement catheter comprises a curvature along a length of the engagement catheter.

18. The system of claim 17, wherein the curvature of the engagement catheter forms an angle that is approximately forty-five degrees.

19. The system of claim 17, wherein the curvature of the engagement catheter forms an angle that is approximately ninety degrees, so that a portion of the engagement catheter is approximately perpendicular to another portion of the engagement catheter.

20. The system of claim 17, wherein the curvature of the engagement catheter forms an angle so that a portion of the engagement catheter is approximately parallel to another portion of the engagement catheter.

21. An engagement catheter for use with a vacuum source for engaging a tissue, the engagement catheter 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 between the outer wall and the inner wall, the elongated tube further defining a delivery catheter lumen configured to receive a delivery catheter and an injection channel formed along a length of the elongated tube, the injection channel being ring-shaped at its distal end and having at its distal end at least one opening for administering a substance to a targeted tissue;

a skirt operatively connected to the distal end of the tube, the skirt comprising a proximal end having a circumference substantially similar to an outer circumference of the tube, the skirt further comprising a distal end having a circumference larger than the circumference of the tube;

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

a suction port in communication with the at least one suction channel at the distal end of the tube, the suction port configured to allow the distal end of the skirt to removably engage a surface of a bodily tissue such that the skirt is capable of forming a reversible seal with the surface of the tissue when a vacuum source is operatively attached to the vacuum port.

22. The engagement catheter of claim 21, wherein the skirt comprises a deformable configuration, and wherein the deformable configuration of the skirt is capable of expanding to an expanded configuration.

23. The engagement catheter of claim 22, wherein the expanded configuration is a frusto-conical configuration.

24. The engagement catheter of claim 22, wherein the expanded configuration is a an irregular frusto-conical configuration.

25. The engagement catheter of claim 22, wherein the skirt has a collapsed configuration when the skirt is at least partially surrounded by a sleeve, and wherein the skirt has an expanded configuration when the skirt is not surrounded by the sleeve.

26. The engagement catheter of claim 21, wherein the skirt is capable of enlarging a pericardial space between a heart and a pericardial sac when the skirt is attached to an interior wall of the heart.

27. The engagement catheter of claim 21, 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 a substantial portion of the length of the tube.

28. The engagement catheter of claim 27, wherein the at least one internal lumen support comprises two internal lumen supports, and the at least one suction channel comprises two suction channels.

29. The engagement catheter of claim 21, wherein the injection channel is 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.

30. A method of engaging a tissue, the method comprising the steps of:

providing a system, comprising;

an engagement catheter comprising a proximal end, a distal end, first and second lumens extending between the proximal end and the distal end, an injection channel formed along a length of the engagement catheter, the injection channel being ring-shaped at its distal end and having at its distal end at least one opening for administering a substance to a targeted tissue, and a skirt operatively connected to the distal end, the skirt comprising a proximal end having a circumference substantially similar to an outer circumference of the engagement catheter, the skirt further comprising a distal end having a circumference larger than the outer circumference of the engagement catheter;

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;

a needle located at the distal end of the delivery catheter; and

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

wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to allow the distal end of the skirt to removably engage a surface of a targeted tissue such that the skirt is capable of forming a reversible seal with the surface of the targeted tissue when a vacuum source is operatively attached to the vacuum port; and

inserting the engagement catheter into a body such that the distal end of the engagement catheter is positioned at or near the targeted tissue.

31. The method of claim 30, wherein the system is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds a heart by retracting the targeted tissue away from the pericardial sac.

32. The method of claim 31, wherein the step of inserting the engagement catheter into a body comprises the insertion of the engagement catheter such that the distal end of the engagement catheter is positioned inside the heart and the skirt is in contact with the targeted tissue on the interior of a wall of the heart.

33. The method of claim 32, further comprising the step of operatively connecting a vacuum source to the vacuum port such that the skirt is reversibly attached to the targeted tissue on the interior of a wall of the heart.

34. The method of claim 33, further comprising the step of inserting the delivery catheter into the second lumen of the engagement catheter.

35. The method of claim 34, further comprising the step of piercing the targeted tissue on the interior of a wall of the heart with the needle.

36. The method of claim 35, further comprising the step of administering a substance into the pericardial space.

37. The method of claim 35, further comprising the steps of withdrawing the needle from the targeted tissue and administering a substance to the targeted tissue after withdrawal of the needle.

38. The method of claim 37, wherein the substance comprises an adhesive for sealing a puncture wound in the targeted tissue.

39. The method of claim 30, wherein the targeted tissue comprises a portion of an atrial wall.

40. The method of claim 30, wherein the targeted tissue comprises a portion of an atrial appendage.

41. The method of claim 35, further comprising the step of accessing the pericardial space by inserting a guide wire through the wall of the heart into the pericardial space.