Devices and systems for accessing cardiac tissue

• US 9,907,954 B2
• Filed: 11/25/2014
• Issued: 03/06/2018
• Est. Priority Date: 06/30/2006
• Status: Active Grant

• Current Assignee: CVDEVICES, LLC
• Original Assignee: CVDEVICES, LLC
• Inventors: Kassab, Ghassan S., Navia, Sr., Jose A.
• Primary Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US14/552,708
• Publication Number:
  US 20150080805A1
• Time in Patent Office: 1,197 Days
• 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;

an elongated tube comprising a proximal end, a distal end, and a single 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 single internal lumen and capable of operative connection to a vacuum source; and

a suction port in communication with the single 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;

wherein the engagement catheter is configured to permit at least a portion of the engagement catheter to be retracted after percutaneous intravascular insertion, while remaining removably attached to the targeted tissue due to vacuum from the vacuum source through the single internal 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, the second device selected from the group consisting of a delivery catheter and a needle; and

wherein the engagement catheter is configured to receive the second device delivered through the vacuum port into the single internal lumen of the engagement catheter and to permit operation of the second device within the single internal lumen while maintaining the reversible seal under vacuum.

2. The engagement catheter of claim 1, 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 single internal lumen of the engagement catheter.

3. The engagement catheter 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 engagement catheter of claim 1, further comprising:

at least one internal lumen support positioned within the single 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.

5. The engagement catheter of claim 4, wherein the elongated tube comprises a second lumen extending between the proximal end and the distal end.

6. The engagement catheter of claim 1, 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.

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

an engagement catheter comprising;

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

a suction port located at or near the distal end of the engagement catheter and in communication with the single lumen of the engagement catheter, the suction port configured to allow the distal end 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 single lumen of the engagement catheter and capable of operative connection to a vacuum source;

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

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

wherein the engagement catheter is configured to locally increase a distance between the bodily tissue and a second tissue behind the first tissue by retracting the bodily tissue away from the second tissue while the reversible seal is formed; and

a second device, the second device selected from the group consisting of a delivery catheter and a needle; and

wherein the engagement catheter is configured to receive the second device delivered through the vacuum port into the single lumen of the engagement catheter and to permit operation of the second device within the single lumen while maintaining the reversible seal under vacuum.

8. The engagement catheter of claim 7, 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.

9. The engagement catheter of claim 7, wherein the engagement catheter is configured so that when the engagement catheter is used to form the reversible seal under vacuum through the single lumen using the suction port, a second device can be delivered through the vacuum port into the single lumen of the engagement catheter while maintaining the reversible seal.

10. The engagement catheter of claim 7, wherein the engagement catheter is configured for advancement to a heart through the blood vessel.

11. The engagement catheter of claim 10, wherein the second tissue comprising a pericardium surrounding the heart, and wherein the engagement catheter is capable of locally increasing a pericardial space between the bodily tissue and the pericardium.

12. A system for engaging mammalian tissue, comprising:

an engagement catheter, comprising;

an elongated tube comprising a proximal end, a distal end, and a single 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 single internal lumen and capable of operative connection to a vacuum source; and

a suction port in communication with the single internal lumen at or near the distal end of the tube, the suction port configured to removably engage a targeted tissue, 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;

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

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;

wherein the engagement catheter is configured to permit at least a portion of the engagement catheter to be retracted after percutaneous intravascular insertion, while remaining removably attached to the targeted tissue due to vacuum from the vacuum source through the single internal lumen of the engagement catheter and suction engagement from the suction port, so to locally increase a distance between the targeted tissue and a second tissue behind the bodily tissue; and

a second device, the second device selected from the group consisting of a delivery catheter and a needle; and

wherein the engagement catheter is configured to receive the second device delivered through the vacuum port into the single internal lumen of the engagement catheter and permit operation of the second device within the single internal lumen while maintaining the reversible seal under vacuum.

13. The engagement catheter of claim 12, 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 single internal lumen of the engagement catheter.

14. The engagement catheter of claim 12, 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.

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

at least one internal lumen support positioned within the single 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.

16. The engagement catheter of claim 15, wherein the elongated tube comprises a second lumen extending between the proximal end and the distal end.

17. The engagement catheter of claim 12, 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.

18. The engagement catheter of claim 12, wherein the engagement catheter is configured for advancement to a heart through the blood vessel.