Engagement catheter systems and devices and methods of using the same

• US 8,876,776 B2
• Filed: 12/12/2011
• Issued: 11/04/2014
• 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): Price, Nathan R
• Application Number:
  US13/323,174
• Publication Number:
  US 20120116317A1
• Time in Patent Office: 1,058 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, 607/120, 607/122, 607/126, 607/129, 607/130
• US Class Current: 604/176
• 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

An engagement catheter for use with a vacuum source for engaging a tissue. An embodiment of the engagement catheter includes a first lumen extending between a proximal end and a distal end, a skirt operatively connected to the distal end, the skirt having a distal end with a circumference larger than the outer circumference of the engagement catheter, 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, and a vacuum port located at the proximal end of the engagement catheter and capable of operative connection to a vacuum source, wherein when a vacuum source is operatively attached to the vacuum port, the skirt is capable of forming a reversible seal with the surface of the bodily tissue.

Claims

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

an engagement catheter comprising;

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

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, and

a suction port located at or near the distal end of the engagement catheter and in communication with the first lumen 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;

a needle located within the first lumen of the engagement catheter; and

a vacuum port located at the proximal end of the engagement catheter, the vacuum port in communication with the first lumen of the engagement catheter and capable of operative connection to a vacuum source;

wherein when a vacuum source is operatively attached to the vacuum port, the skirt is capable of forming a reversible seal with the surface of the bodily tissue; and

wherein the system is configured for use so that at least one additional device selected from a diagnostic device and a therapeutic device can be at least partially positioned within the first lumen of the engagement catheter.

2. The system of claim 1, wherein the system is capable of locally increasing a distance between the bodily tissue and a pericardium that surrounds a heart by retracting the bodily tissue away from the pericardium while the reversible seal is formed.

3. The system of claim 1, wherein the system is capable of locally increasing a distance between an outer surface of a heart and a pericardium that surrounds the heart when the skirt is attached to an interior wall of the heart and when the engagement catheter is retracted.

4. 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.

5. The system of claim 1, further comprising:

a sleeve defining a sleeve lumen extending from a proximal sleeve end to a distal sleeve end, wherein when the sleeve is positioned around the engagement catheter, the sleeve slidingly engages the engagement catheter, and wherein when the sleeve is positioned at the distal end of the engagement catheter, the sleeve at least partially surrounds the skirt.

6. The system of claim 1, wherein the needle is positioned to be capable of piercing the bodily tissue when the suction port is attached to the bodily tissue, such that, when the bodily tissue is pierced, access to a pericardial space is achieved.

7. The system of claim 6, further comprising:

a guide wire for insertion into the pericardial space, wherein the needle comprises a hollow needle and wherein the guide wire is capable of insertion through the hollow needle into the pericardial space.

8. The system of claim 1, further comprising:

an injection channel formed along a length of the engagement catheter, the injection channel having at its distal end at least one opening for administering a substance to the bodily tissue.

9. The system of claim 8, wherein the injection channel is ring-shaped.

10. The system of claim 8, wherein the injection channel is capable of operable attachment to an external fluid source at a proximal end of the injection channel, such that fluid from the external fluid source can flow through the injection channel to the bodily tissue when the external fluid source is operatively attached to the injection channel.

11. The system of claim 1, wherein the engagement catheter comprises a curvature along a length of the engagement catheter at or near the distal end of the engagement catheter.

15. The system of claim 1, wherein when the vacuum source is operatively attached to the vacuum port, the skirt is capable of forming a reversible seal with the surface of the bodily tissue selected from the group consisting of an atrial wall, a left atrial wall, a right atrial wall, an atrial appendage, a left atrial appendage, and a right atrial appendage.

12. An engagement catheter for use with a vacuum source for engaging a tissue, the engagement catheter comprising:

a first lumen extending between a proximal end and a distal end;

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 suction port located at or near the distal end of the engagement catheter and in communication with the first lumen 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; and

a vacuum port located at the proximal end of the engagement catheter, the vacuum port in communication with the first lumen of the engagement catheter and capable of operative connection to a vacuum source;

wherein when a vacuum source is operatively attached to the vacuum port, the skirt is capable of forming a reversible seal with the surface of the bodily tissue; and

wherein the engagement catheter is capable of locally increasing a distance between the bodily tissue and a pericardium that surrounds a heart by retracting the bodily tissue away from the pericardium while the reversible seal is formed.

13. The engagement catheter of claim 12, further comprising:

a second lumen extending between the proximal end and the distal end, the first lumen and the second lumen separated by an inner wall within the engagement catheter and having a concentric axis; and

at least one internal lumen support positioned within the second lumen and attached to the inner wall and an outer wall of the engagement catheter along at least a substantial portion of a longitudinal length of the engagement catheter.

14. The engagement catheter of claim 12, 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.

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

introducing at least part of a system into a luminal organ of a patient, the system comprising;

an engagement catheter comprising;

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

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, and

a suction port located at or near the distal end of the engagement catheter and in communication with the first lumen 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;

a needle located within the first lumen of the engagement catheter; and

a vacuum port located at the proximal end of the engagement catheter, the vacuum port in communication with the first lumen of the engagement catheter and capable of operative connection to a vacuum source, wherein when a vacuum source is operatively attached to the vacuum port, the skirt is capable of forming a reversible seal with the surface of the bodily tissue; and

positioning the distal end of the engagement catheter at or near the bodily tissue; and

operating the vacuum source so that the skirt forms a reversible seal with the surface of the bodily tissue and so that a distance between the bodily tissue and a pericardium that surrounds a heart is locally increased by retracting the bodily tissue away from the pericardium by retracting the engagement catheter.

17. The method of claim 16, further comprising the step of:

piercing the bodily tissue with the needle to provide access to the pericardial space through an aperture in the bodily tissue.

18. The method of claim 17, further comprising the step of:

accessing the pericardial space by inserting a guide wire through the aperture so that a distal end of the guide wire is positioned within the pericardial space.

19. The method of claim 18, further comprising the step of:

removing the engagement catheter from the luminal organ of the patient; and

advancing at least one additional device selected from a diagnostic device and a therapeutic device along the guide wire so that a distal end of the at least one additional device is positioned through the aperture and into the pericardial space.