Systems and methods for engaging heart tissue

• US 8,777,904 B2
• Filed: 07/02/2012
• Issued: 07/15/2014
• 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): Schmidt, Emily
• Assistant Examiner(s): Anderson, Michael J
• Application Number:
  US13/539,574
• Publication Number:
  US 20120277725A1
• Time in Patent Office: 743 Days
• Field of Search: 606/508, 606/213, 606/129, 604/508
• 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

A system for engaging heart tissue includes an engagement catheter defining a first lumen therethrough and having a suction port at or near a distal end and a vacuum port at or near a proximal end, a delivery catheter defining a delivery catheter lumen therethrough and configured for slidable insertion into the first lumen of the engagement catheter, and an implantable device capable of insertion into the delivery catheter lumen such that at least part of the implantable device extends from a delivery catheter distal end upon implantation into a patient, where the suction port is operable to removably attach to a targeted tissue on an interior wall of a heart of the patient after the engagement catheter has been advanced through a blood vessel and into the heart, thereby forming a reversible seal with the targeted tissue when a vacuum source is operatively coupled to the vacuum port.

Claims

1. A system for engaging heart tissue, the system comprising:

an engagement catheter extending from a distal end to a proximal end and defining a first lumen therethrough, the engagement catheter having a suction port at or near the distal end and a vacuum port at or near the proximal end;

a delivery catheter comprising an elongated tube extending from a delivery catheter distal end to a delivery catheter proximal end and defining a delivery catheter lumen therethrough, the delivery catheter configured for slidable insertion into the first lumen of the engagement catheter; and

an implantable device configured for insertion into the delivery catheter lumen and further configured so that at least part of the implantable device extends from the delivery catheter distal end upon implantation into a patient;

wherein the delivery catheter lumen has a bend, relative to the elongated tube, at or near the delivery catheter distal end, and a bend outlet through the elongated tube, so that a portion of the implantable device can be delivered through the delivery catheter lumen, to the bend, and out of the bend outlet; and

wherein the suction port is configured to removably attach to a targeted tissue on an interior wall of a heart of the patient after the engagement catheter has been advanced through a blood vessel and into the heart, the suction port forming a reversible seal with the targeted tissue when a vacuum source is operatively coupled to the vacuum port; and

wherein the implantable device comprises an elongated shaft with a plug positioned thereon, the plug defining a hole extending from a plug distal end to a plug proximal end, wherein at least part of the elongated shaft is positioned within the hole.

2. The system of claim 1, wherein the engagement catheter further defines a second lumen therethrough, and wherein the delivery catheter is also configured for slidable insertion into the second lumen of the engagement catheter.

3. The system of claim 1, wherein the delivery catheter further comprises a needle positioned upon or within the delivery catheter, the needle capable of piercing the targeted tissue to form a targeted tissue aperture for delivery of a guidewire or a substance through the targeted tissue aperture.

4. The system of claim 1, wherein the engagement catheter further comprises an injection channel having a distal end opening and configured for attachment to an external substance source, such that a substance can be delivered from the external substance source, through the injection channel, and into the targeted tissue.

5. The system of claim 4, wherein the delivery catheter further comprises a needle positioned upon or within the delivery catheter, the needle capable of piercing the targeted tissue to form a targeted tissue aperture for delivery of a guidewire or a substance through the targeted tissue aperture.

6. The system of claim 1, wherein the plug is configured to close an aperture within a patient tissue after the plug distal end is positioned within the aperture.

7. The system of claim 1, wherein the plug distal end has a smaller diameter than the plug proximal end, and wherein the hole defined within the plug is self-sealing upon removal of the shaft from the hole.

8. 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.

9. A system for engaging heart tissue, the system comprising:

an engagement catheter extending from a distal end to a proximal end and defining a first lumen therethrough, the engagement catheter having a suction port at or near the distal end and a vacuum port at or near the proximal end;

a delivery catheter comprising an elongated tube extending from a delivery catheter distal end to a delivery catheter proximal end and defining a delivery catheter lumen therethrough, the delivery catheter configured for slidable insertion into the first lumen of the engagement catheter; and

an implantable device configured for insertion into the delivery catheter lumen and further configured so that at least part of the implantable device extends from the delivery catheter distal end upon implantation into a patient;

wherein the delivery catheter lumen has a bend, relative to the elongated tube, at or near the delivery catheter distal end, and a bend outlet through the elongated tube, so that a portion of the implantable device can be delivered through the delivery catheter lumen, to the bend, and out of the bend outlet; and

wherein the suction port is configured to removably attach to a targeted tissue on an interior wall of a heart of the patient after the engagement catheter has been advanced through a blood vessel and into the heart, the suction port forming a reversible seal with the targeted tissue when a vacuum source is operatively coupled to the vacuum port; and

wherein the implantable device comprises a closure member having a first cover and a second cover, the closure member configured to transition from a folded configuration from within the delivery catheter lumen to an expanded configuration outside of the delivery catheter lumen, the first cover and the second cover each configured for reversible attachment to a distal end of a delivery wire, the closure member configured to close an aperture within a patient tissue.

10. The system of claim 9, wherein when the first cover is positioned through the aperture and expanded on a first side of the patient tissue, and wherein when the second cover is expanded on the second side of the patient tissue at or near the aperture, the first cover and the second cover effectively closes the aperture.

11. The system of claim 9, wherein the engagement catheter further defines a second lumen therethrough, and wherein the delivery catheter is also configured for slidable insertion into the second lumen of the engagement catheter.

12. The system of claim 9, wherein the delivery catheter further comprises a needle positioned upon or within the delivery catheter, the needle capable of piercing the targeted tissue to form a targeted tissue aperture for delivery of a guidewire or a substance through the targeted tissue aperture.

13. The system of claim 9, wherein the engagement catheter further comprises an injection channel having a distal end opening and configured for attachment to an external substance source, such that a substance can be delivered from the external substance source, through the injection channel, and into the targeted tissue.

14. The system of claim 13, wherein the delivery catheter further comprises a needle positioned upon or within the delivery catheter, the needle capable of piercing the targeted tissue to form a targeted tissue aperture for delivery of a guidewire or a substance through the targeted tissue aperture.

15. A system for engaging heart tissue, the system comprising:

an engagement catheter extending from a distal end to a proximal end and defining a first lumen therethrough, the engagement catheter having a suction port at or near the distal end and a vacuum port at or near the proximal end;

a delivery catheter comprising an elongated tube extending from a delivery catheter distal end to a delivery catheter proximal end and defining a delivery catheter lumen therethrough, the delivery catheter configured for slidable insertion into the first lumen of the engagement catheter; and

an implantable device configured for insertion into the delivery catheter lumen and further configured so that at least part of the implantable device extends from the delivery catheter distal end upon implantation into a patient;

wherein the delivery catheter lumen has a bend, relative to the elongated tube, at or near the delivery catheter distal end, and a bend outlet through the elongated tube, so that a portion of the implantable device can be delivered through the delivery catheter lumen, to the bend, and out of the bend outlet; and

wherein the suction port is configured to removably attach to a targeted tissue on an interior wall of a heart of the patient after the engagement catheter has been advanced through a blood vessel and into the heart, the suction port forming a reversible seal with the targeted tissue when a vacuum source is operatively coupled to the vacuum port; and

wherein the implantable device comprises a closure member having a head and a plurality of arms extending from the head, the closure member configured to transition between an open position and a closed position, the closure member operable to close an aperture within a patient tissue.

16. The system of claim 15, wherein the closure member is operable to close the aperture by engaging the patient tissue using the plurality of arms and transitioning from the open position to the closed position.

17. The system of claim 15, wherein the engagement catheter further defines a second lumen therethrough, and wherein the delivery catheter is also configured for slidable insertion into the second lumen of the engagement catheter.

18. The system of claim 15, wherein the delivery catheter further comprises a needle positioned upon or within the delivery catheter, the needle capable of piercing the targeted tissue to form a targeted tissue aperture for delivery of a guidewire or a substance through the targeted tissue aperture.

19. The system of claim 15, wherein the engagement catheter further comprises an injection channel having a distal end opening and configured for attachment to an external substance source, such that a substance can be delivered from the external substance source, through the injection channel, and into the targeted tissue.

20. The system of claim 19, wherein the delivery catheter further comprises a needle positioned upon or within the delivery catheter, the needle capable of piercing the targeted tissue to form a targeted tissue aperture for delivery of a guidewire or a substance through the targeted tissue aperture.