Remote pericardial hemostasis for ventricular access and reconstruction or other organ therapies

• US 9,095,363 B2
• Filed: 09/30/2012
• Issued: 08/04/2015
• Est. Priority Date: 09/30/2011
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Van Bladel, Kevin, Annest, Lon, Stiggelbout, John, Arcia, Rovil
• Primary Examiner(s): Matthews, Christine H
• Assistant Examiner(s): Lannu, Joshua D
• Application Number:
  US13/632,103
• Publication Number:
  US 20130090523A1
• Time in Patent Office: 1,038 Days
• Field of Search: 600/37
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• 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 17/0057 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0422 by insertion of a separate member into the body of the anchor
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22065 : Functions of balloons
• CPC Class Codes: A61B 2017/2215 : having an open distal end
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/3458 : threaded
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 34/70 : Manipulators specially adapted for use in surgery
• CPC Class Codes: A61B 5/0215 : by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Embodiments described herein provide devices, systems, and methods that reduce the distance between two locations in tissue, often for treatment of congestive heart failure. For example, an anchor of an implant system may, when the implant system is fully deployed, reside within the right ventricle in engagement with the ventricular septum. The anchor may be deployed into the heart through a working lumen of a minimally invasive access tool. The minimally invasive access tool may have a plurality of grippers near a distal end of the working lumen. The grippers may engage epicardial tissue of the heart and may be moved radially inwardly relative so as to provide stabilization of the epicardial tissue and/or hemostasis near an access site where the anchor is inserted through the epicardium. The minimally invasive access tool may minimize blood loss from the access site and improve anchor implant processes.

Claims

1. A system for engaging epicardial tissue of a patient'"'"'s heart, the system comprising:

an elongate tool body having a proximal end and a distal end, the elongate tool body being insertable through a body wall of the patient and the elongate tool body having a lumen that is fluidly coupled with a vacuum source positioned external to the patient; and

a gripping device near the distal end of the elongate tool body and operable therewith, the gripping device being disposed radially outwardly of the lumen and being configured to be releasably attached to the epicardial tissue of the heart around an access site of an intracardiac device that is configured to perform a medical procedure within a chamber of the heart;

wherein the gripping device is coupled with an actuator that is articulatable from outside the patient body so as to move the gripping device radially inwardly toward an axis of the intracardiac device so as to facilitate stabilizing or hemostasis of the heart about the intracardiac device; and

wherein the gripping device comprises a suction device having an arcuate suction channel, the arcuate suction channel having a plurality of suction ports positioned on a bottom surface that are configured to contact the epicardial tissue, the suction ports being configured to releasably attach the gripping device to the epicardial tissue via suction through the suction ports, and wherein the arcuate suction channel comprises an aperture shaped and sized to receivably couple with an outer surface of the intracardiac device,

wherein said aperture is surrounded by the plurality of suction ports.

2. The system of claim 1, wherein the suction device comprises a suction pad at the distal end of the elongate tool body, the suction pad comprising the plurality of suction ports in fluid communication with a suction lumen.

3. The system of claim 1, wherein at least one of the suction ports comprises a suction pad comprising a resilient material that allows the suction pad to be pressed against and engage the epicardial tissue, the at least one of the suction ports being positioned toward a center of the suction pad.

4. The system of claim 1, wherein the arcuate suction channel comprises a radially extending slot that allows the arcuate suction channel to be inserted over the intracardiac device by inserting the intracardiac device through the slot.

5. The system of claim 4, wherein opposing ends of the arcuate suction channel adjacent the slot are movable circumferentially upon operation of the actuator to apply a contracting force to the epicardial tissue engaged by the arcuate suction channel so as to facilitate stabilizing or hemostasis of the heart about the intracardiac device.

6. The system of claim 4, wherein the arcuate suction channel is configured to radially contract upon operation of the actuator to apply a contracting force to the epicardial tissue engaged by the arcuate suction channel so as to facilitate stabilizing or hemostasis of the heart about the intracardiac device.

7. The system of claim 1, wherein the actuator comprises a ratchet mechanism and a handle that is configured to be grasped by a user'"'"'s hand.

8. A device for accessing tissue within a patient'"'"'s heart, the device comprising:

an elongate tool body having a proximal end and a distal end, the elongate tool body being insertable through a body wall of the patient and the elongate tool body having a lumen therethrough, the lumen being fluidly coupled with a vacuum source positioned external to the patient; and

a gripping device near the distal end of the elongate tool body and operable therewith, the gripping device disposed radially outwardly of the working lumen and being configured to be releasably attached to epicardial tissue of the heart around an access site of an intracardiac device that is configured to perform a medical procedure within the heart;

wherein the gripping device is coupled to an actuator, the actuator being articulatable from outside the patient body so as to move the gripping device radially inwardly toward an axis of the intracardiac device so as to facilitate hemostasis of the heart about the intracardiac device; and

wherein the gripping device comprises a suction device having an arcuate suction channel, the arcuate suction channel having a plurality of suction ports positioned on a bottom surface that are configured to contact the epicardial tissue, the suction ports being configured to releasably attach the gripping device to the epicardial tissue via suction through the suction ports, and wherein the arcuate suction channel comprises a radially extending slot that allows the arcuate suction channel to be inserted over the intracardiac device,

wherein said radially extending slot is surrounded by the plurality of suction ports.

9. A method for accessing tissue within a patient'"'"'s

heart, the method comprising:

providing an epicardial engagement tool comprising;

an elongate tool body having a proximal end and a distal end, the elongate tool body being insertable through a body wall of the patient and the elongate tool body having a lumen that is fluidly coupled with a vacuum source positioned external to the patient; and

a gripping device near the distal end of the elongate tool body and operable therewith, the gripping device being disposed radially outwardly of the lumen and being configured to releasably attach to epicardial tissue of the heart around an access site of an intracardiac device that is configured to perform a medical procedure within the chamber;

wherein the gripping device is coupled with an actuator that is articulatable from outside the patient body so as to move the gripping device radially inwardly toward an axis of the intracardiac device so as to facilitate stabilizing or hemostasis of the heart about the intracardiac device;

wherein the gripping device comprises a suction device having an arcuate suction channel, the arcuate suction channel having a plurality of suction ports positioned on a bottom surface that are configured to contact the epicardial tissue, the suction ports being configured to releasably attach the gripping device to the epicardial tissue via suction through the suction ports, and wherein the arcuate suction channel comprises an aperture shaped and sized to receivably couple with an outer surface of the intracardiac device; and

wherein said aperture is surrounded by the plurality of suction ports;

positioning the gripping device through a body wall of the patient to adjacent the epicardial tissue of the heart;

inserting an intracardiac device through the lumen and through the epicardial tissue of the heart at an access site so that a distal end of the intracardiac device is within the chamber;

releasably affixing the suction device to the epicardial tissue of the heart so that the gripping device is disposed about the access site; and

contracting the gripping device so as to facilitate stabilizing or hemostasis of the heart about the intracardiac device.

10. The method of claim 9, further comprising applying suction to the suction device.

11. The method of claim 9,

wherein the method further comprises inserting the intracardiac device within the aperture of the arcuate suction channel so that the suction device is releasably coupled about an outer surface of the intracardiac device.

12. The method of claim 11, further comprising actuating the actuator to circumferentially move opposing ends of the arcuate suction channel adjacent the aperture of the arcuate suction channel so as to apply a contracting force to the epicardial tissue engaged by the arcuate suction channel.