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

• US 9,937,043 B2
• Filed: 07/31/2015
• Issued: 04/10/2018
• 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 DARYL DEANON
• Application Number:
  US14/815,775
• Publication Number:
  US 20160030026A1
• Time in Patent Office: 984 Days
• 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 extending between 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 working lumen through which an intracardiac device is inserted to perform a medical procedure within a chamber of the heart; and

a suction device disposed at the distal end of the elongate tool body and operable therewith, the suction device being disposed radially outwardly of and surrounding the working lumen, the suction device being configured to be releasably attached to the epicardial tissue of the heart around the working lumen when performing the medical procedure within the chamber;

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

wherein the suction device comprises a large disc-shaped suction pad that entirely surrounds the working lumen, the disc-shaped suction pad having a radial length that extends from the working lumen to a circumferential edge that is positioned radially outward from an outer surface of the elongate tool body;

wherein the intracardiac device is configured for insertion through the working lumen of the elongate tool body; and

wherein the disc-shaped suction pad is configured to radially contract upon operation of an actuation mechanism to apply a contracting force to the epicardial tissue engaged by the disc-shaped suction pad so as to facilitate stabilizing or hemostasis of the heart about the intracardiac device.

2. The system of claim 1, wherein the disc-shaped suction pad comprises a resilient material that enables the disc-shaped suction pad to be pressed against and engage the epicardial tissue.

3. The system of claim 2, wherein the disc-shaped suction pad comprises a plurality of suction ports in fluid communication with a suction lumen.

4. A tissue engagement device comprising:

an elongate tool body extending between 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 working lumen through which an intracardiac device is inserted to perform a medical procedure within a chamber of a heart;

a large disc-shaped suction pad disposed on the distal end of the elongate tool body, the disc-shaped suction pad entirely surrounding the working lumen and having a radial length that extends from the working lumen to a circumferential edge that is positioned radially outward from an outer surface of the elongate tool body, the disc-shaped suction pad being configured to releasably engage epicardial tissue of a patient'"'"'s heart via suction and thereby stabilize the epicardial tissue relative to the working lumen of the elongate tool body; and

a suction lumen in fluid communication with the disc-shaped suction pad, the suction lumen being couplable with a suction device disposed external to the patient to provide suction to the disc-shaped suction pad from outside the body.

5. The tissue engagement device of claim 4, wherein the disc-shaped suction pad comprises a plurality of suction ports in fluid communication with the suction lumen.

6. The tissue engagement device of claim 4, wherein the disc-shaped suction pad is configured to radially contract to apply a contracting force to the epicardial tissue engaged by the disc-shaped suction pad so as to facilitate stabilizing or hemostasis of the heart about the intracardiac device.

7. A method for providing hemostasis to tissue within a patient'"'"'s heart, the method comprising:

obtaining a tissue engagement device comprising;

an elongate tool body having a proximal end, a distal end, and a working lumen extending between the proximal end and the distal end; and

a suction device disposed at the distal end of the elongate tool body and disposed radially outwardly of and surrounding at least a portion of the working lumen;

positioning the elongate tool body through a body wall of the patient so that the distal end of the elongate tool body is adjacent an epicardial tissue of the heart;

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

actuating the suction device to releasably affix the distal end of the elongate tool body to the epicardial tissue of the heart so that the suction device surrounds the access site;

and contracting the suction device to contract the epicardial tissue about the intracardiac device.

8. The method of claim 7, wherein the suction device comprises a suction pad comprising a resilient material that enables the suction pad to be pressed against and engage the epicardial tissue.

9. The method of claim 8, wherein the suction pad comprises a plurality of suction ports in fluid communication with a suction lumen of the elongate tool body.

10. The method of claim 9, wherein the suction pad comprises an arcuate suction channel that is configured to engage the epicardial tissue via suction.

11. The method of claim 10, wherein the arcuate suction channel includes a plurality of suction ports that are configured to releasably attach the suction device to the epicardial tissue via suction through each of the suction ports of the arcuate suction channel.

12. The method of claim 11, wherein contracting the suction device further comprises actuating an actuator to circumferentially move opposing ends of the arcuate suction adjacent the access site so as to apply a contracting force to the epicardial tissue.

13. The method of claim 10, wherein the arcuate suction channel entirely surrounds the access site, and wherein the arcuate suction channel is configured to radially contract to apply a contracting force to the epicardial tissue.