Devices, systems, and methods for accessing the epicardial surface of the heart

• US 8,211,084 B2
• Filed: 02/05/2008
• Issued: 07/03/2012
• 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): Ho, Jackie
• Assistant Examiner(s): Anderson, Michael J
• Application Number:
  US12/596,964
• Publication Number:
  US 20110130744A1
• Time in Patent Office: 1,610 Days
• Field of Search: 604/508, 606/213, 606/129
• US Class Current: 604/508
• 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 2025/0039 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 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• 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 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61N 1/0587 : Epicardial electrode systems; Endocardial electrodes piercing the pericardium

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 leads to the heart tissue. In addition, various disclosed embodiments provide devices, systems, and methods for closing a hole in cardiac tissue.

Claims

1. A system for use with a vacuum source for placing a lead into a tissue of a heart, 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 delivery catheter comprising an elongated tube having a wall and a first lumen, wherein the delivery catheter is configured such that the delivery catheter is capable of at least partial insertion into the second lumen of the engagement catheter;

a lead having a tip at a distal end, the lead configured for at least partial insertion into the first lumen 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 being configured to removably attach to a targeted tissue on an interior of a wall of a heart after the engagement catheter has been advanced through a blood vessel into the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when the vacuum source is operatively attached to the vacuum port.

2. The system of claim 1, wherein:

the first lumen of the delivery catheter extends from approximately the proximal end of the tube to or near the distal end of the tube, the first lumen of the delivery catheter having a bend, relative to the tube, at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube.

3. The system of claim 2, wherein:

the bend of the first lumen of the delivery catheter forms an angle that is approximately 90-degrees.

4. The system of claim 2, wherein:

the delivery catheter further comprises a second lumen extending from approximately the proximal end of the tube to or near the distal end of the tube, the second lumen of the delivery catheter having a bend, relative to the tube, at or near the distal end of the tube and an outlet through the wall of the tube at or near the distal end of the tube.

5. The system of claim 4, wherein:

the bend of the first lumen of the delivery catheter forms an angle that is approximately 90-degrees, wherein the bend of the first lumen facilitates delivery of the lead to an external surface of the heart when at least part of the delivery catheter is positioned within a pericardial space; and

the bend of the second lumen of the delivery catheter forms an angle that is approximately 90-degrees.

6. The system of claim 2, wherein:

the lead comprises a pacing lead; and

the tip of the pacing lead has a substantially screw-like shape.

7. The system of claim 1, wherein:

the delivery catheter further comprises a steering channel extending from a proximal end of the tube to a distal end of the tube and a steering wire system at least partially located in the steering channel; and

the steering wire system comprises a first steering wire, a second steering wire, and a controller, each of the first and second steering wires being attached to the wall of the tube within the steering channel and the controller being attached to a proximal end of each of the first and second steering wires.

8. The system of claim 7, wherein:

the controller of the steering wire system comprises a first handle attached to the proximal end of the first steering wire and a second handle attached to the proximal end of the second steering wire.

9. The system of claim 7, wherein:

the controller of the steering wire system comprises a torque system having a first rotatable spool capable of collecting and dispensing the first steering wire and a second rotatable spool capable of collecting and dispensing the second steering wire.

10. The system of claim 7, wherein:

the steering wire system further comprises a third steering wire;

the first steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the first steering wire and the wall forming a first attachment point;

the second steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the second steering wire and the wall forming a second attachment point;

the third steering wire is attached to the wall of the tube within the steering channel at the distal end of the tube, the attachment between the third steering wire and the wall forming a third attachment point; and

the third attachment point is closer to the proximal end of the tube than is the first attachment point or the second attachment point.

11. The system of claim 7, wherein:

the delivery catheter further comprises a handle at or near the proximal end of the tube; and

the controller of the steering wire system is attached to the handle.

25. 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.

12. A method of placing a lead in a tissue of a heart, the method comprising:

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

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;

accessing the pericardial space through the targeted tissue;

inserting into the first lumen of the elongated tube and over an elongated guide wire a delivery catheter comprising a first lumen, wherein the first lumen of the delivery catheter has a bend at or near the distal end of the delivery catheter to facilitate delivery of a lead into a tissue of the heart when at least part of the delivery catheter is positioned within the pericardial space and an outlet at or near the distal end of the delivery catheter;

advancing at least the distal end of the delivery catheter through the targeted tissue into the pericardial space;

directing the delivery catheter such that the outlet of the first lumen of the delivery catheter is adjacent to the tissue of the heart; and

extending a lead through the first lumen of the delivery catheter into the tissue of the heart.

13. The method of claim 12, wherein:

the delivery catheter further comprises a steering channel and a steering wire system located at least partially within the steering channel; and

the step of directing the delivery catheter such that the outlet of the first lumen of the delivery catheter is adjacent to the tissue of the heart comprises directing the delivery catheter with the steering wire system.

14. The method of claim 13, further comprising:

extending a laser Doppler tip through a second lumen of the delivery catheter to the pericardial space.

15. The method of claim 13, wherein:

the lead is a pacing lead; and

the steering wire system further comprises at least two steering wires attached to the delivery catheter inside the steering channel and a controller attached to the proximal ends of the at least two steering wires, the controller being capable of collecting and dispensing at least one of the at least two steering wires.

16. The method of claim 15, wherein:

the step of directing the delivery catheter using the steering wire system comprises using the controller to tighten at least one of the at least two steering wires.

17. The method of claim 16, further comprising:

inserting into the targeted tissue over the elongated guide wire a plug having a first end, a second end, and a hole extending from the first end to the second end, wherein the hole of the plug is self-sealing after removal of the guide wire.

18. A method of injecting a substance into a cardiac tissue from the pericardial space surrounding the external surface of a heart, the method comprising:

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

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;

accessing the pericardial space through the targeted tissue;

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

inserting into the first lumen of the elongated tube and over the elongated guide wire a delivery catheter comprising a first lumen, wherein the first lumen of the delivery catheter has a bend at or near the distal end of the delivery catheter to facilitate injection of a substance into a cardiac tissue when at least part of the delivery catheter is positioned within the pericardial space and an outlet at or near the distal end of the delivery catheter;

advancing at least the distal end of the delivery catheter through the targeted tissue into the pericardial space;

directing the delivery catheter such that the outlet of the first lumen of the delivery catheter is adjacent to the external surface of the heart;

extending a needle through the first lumen of the delivery catheter into the cardiac tissue; and

injecting the substance into the cardiac tissue.

19. The method of claim 18, wherein:

the substance is selected from the group consisting of gene cells, growth factors, a biodegradable synthetic polymer, a tissue inhibitor, a metalloproteinase, and RGD-liposome biologic glue.

20. The method of claim 18, wherein:

the substance comprises a biodegradable synthetic polymer selected from the group consisting of polylactides, polyglycolides, polycaprolactones, polyanhydrides, polyamides, and polyurethanes.

21. The method of claim 18, wherein:

the substance comprises a tissue inhibitor comprising a metalloproteinase.

22. The method of claim 18, wherein:

the delivery catheter further comprises a second lumen, wherein the second lumen of the delivery catheter has a bend at or near the distal end of the delivery catheter and an outlet at or near the distal end of the delivery catheter.

23. The method of claim 22, wherein:

the delivery catheter further comprises a laser Doppler tip.

24. The method of claim 23, further comprising the step of:

measuring the thickness of the cardiac tissue using the laser Doppler tip.