Treating Dysfunctional Cardiac Tissue

• US 20090093670A1
• Filed: 10/03/2008
• Published: 04/09/2009
• Est. Priority Date: 10/03/2007
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Butler, William, Annest, Lon S., Argento, Claudio, Heflin, Ernest
• Granted Patent: US 8,491,455 B2
• Time in Patent Office: Days
• US Class Current: 600/16
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0237 for heart surgery endoscopic heart surgery A61B2017/00243; endoscopic access devices, i.e. trocars, A61B17/34
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0408 Rivets other bone rivets A61B17/68; rivets for connecting prosthetic parts A61F2002/30433, A61F2220/0041
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/0608 : J-shaped
• CPC Class Codes: A61B 2017/061 : hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 50/30 : Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/249 : Device completely embedded in the heart wall
• CPC Class Codes: A61M 25/0138 : having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Medical devices, systems, and methods reduce the distance between two points in tissue, often for treatment of congestive heart failure and often in a minimally invasive manner. An anchor is inserted along an insertion path through a first wall of the heart. An arm of the anchor is deployed and rotationally positioned according to a desired alignment. Application of tension to the anchor may draw the first and second walls of the heart into contact along a desired contour so as to effect a desired change in the geometry of the heart. Additional anchors may be inserted and aligned with the first anchor to close off a portion of a ventricle such that the ventricle is geometrically remodeled and disease progression is reversed, halted, and/or slowed.

Claims

1. A method for treating a heart of a patient, the heart having a chamber bordered by a plurality of walls, the method comprising:

inserting a first anchor along an insertion path through a first wall of the heart;

laterally deploying an arm of the first anchor;

rotationally positioning the arm of the first anchor about the axis of the insertion path to align the arm per a desired contour; and

drawing first and second walls of the heart into contact along the desired contour by applying tension to the first anchor through the insertion path.

2. The method of claim 1, further comprising:

inserting second and third anchors through the first wall of the tissue along associated insertion paths;

laterally deploying arms of the second and third anchors; and

rotationally positioning the arms of the second and third anchors so that applying tension to the second and third anchors through their associated insertion paths extends the contact sufficiently contiguously along the desired contour to seal between the anchors, the desired contour curving laterally across the first wall.

3. The method of claim 1, further comprising:

inserting a second anchor through a third wall of the tissue along an associated insertion path;

laterally deploying an arm of the second anchor; and

rotationally positioning the arm of the second anchor so that applying tension to the second anchor through the associated insertion path extends the contact along the desired contour, the desired contour extending contiguously from the first wall to the third wall.

4. The method of claim 1, wherein a tension member extends along the path from the inserted first anchor, and wherein the rotationally positioning step is performed by rotating the anchor with the tension member or a tubular body over the tension member.

5. The method of claim 4, wherein an axis of the arm of the first anchor extends along an elongate length from a central region adjacent the tension member to an end,

wherein another arm of the first anchor extends along an elongate length from the central region to another end so that the central region is between the ends, and

wherein the tensioning of the tension member forms a fold in the tissue along the desired contour.

6. The method of claim 1, wherein the anchor is inserted through the wall of the heart from inside the heart by advancing the anchor into the heart within a flexible catheter body.

8. The method of claim 6, wherein the bend in the path is defined by a bent flexible catheter body, and wherein the stiffness of the arm in the second orientation is sufficient to induce contiguous contact of the walls along a contour between the first anchor and a second anchor when arms of the anchors are aligned along the contour, and wherein the stiffness of the arm in the first orientation would not be sufficient to ensure contiguous contact of the walls between the anchors.

7. A method for treating a heart of a patient, the heart having a chamber bordered by a plurality of walls, the method comprising:

inserting a first anchor along an insertion path extending through a first wall of the heart;

flexing an elongate arm of the first anchor in a first orientation during the insertion of the first anchor so as to accommodate a bend in the path;

laterally deploying the arm of the first anchor; and

drawing first and second walls of the heart into contact by applying tension to the first anchor through the insertion path along a second orientation, the arm having a greater stiffness in the second orientation than in the first orientation so as to inhibit deflection of the arm away from the first wall.

9. A system for treating a heart of a patient, the system comprising:

an introducer having a proximal end and a distal end with a shaft therebetween, the distal end insertable along an insertion path through first and second heart walls bordering a chamber of the heart;

a first anchor, the first anchor being axially translatable along the path of the introducer through the heart walls; and

an elongate member extendable proximally from the first anchor and rotationally coupled to the first anchor so as to axially rotate the first anchor from proximally of the heart walls and to orient an arm of the anchor along a desired lateral orientation from the path.

10. The system of claim 9, wherein the first anchor comprises an arm structure pivotally coupled to the elongate member so as to pivot from an insertion configuration to a deployed configuration, the arm structure in the deployed configuration defining first and second arms extendable from the elongate member along a desired contour with the first arm extending along the first orientation and the second arm extending opposite the first orientation, the first and second arms comprising integral portions of the arm structure and the arm structure in the insertion configuration extending along an axis of the elongate member with the first arm extending proximally and the second arm extending distally.

11. The system of claim 9, wherein the elongate member comprises a tension member extending proximally from an elongate shaft of the first anchor, the elongate shaft pivotally coupled to the arm structure.

12. The system of claim 9, wherein the tension member comprises a tether having a plurality of axially repeating features, each of the repeating features comprising at least one of a protrusion, bard, or pawl.

13. The system of claim 9, wherein the arm structure is connected to the elongate member through a flexible joint.

14. The system of claim 9, wherein the anchor comprising a second anchor, the second anchor comprises a locking mechanism operatively engageable with the tension member so as to allow axial movement of the anchors toward each other, and so as to inhibit axial movement of the anchors away from each other.

15. The system of claim 9, further comprising a second anchor and a third anchor, each anchor having an associated elongate member tensionable so as to compress the walls together between the anchor and an associated opposing anchor, the first, second, and third anchors each rotatable about axes of the associated elongate members so as to align arms of the anchors along a desired wall contact contour from proximally of the walls of the heart.

16. A method for treating a heart of a patient, the method comprising:

advancing a distal tip of a catheter into a first ventricle of the heart;

making a first perforation on a septal wall;

advancing the distal tip of the catheter through the first perforation into a second ventricle;

making a second perforation on the wall of the second ventricle;

advancing the distal tip of the catheter through the second perforation into an epicardial space;

inserting an anchor distally of the wall of the second ventricle through a lumen of the catheter and deploying an arm of the anchor laterally;

rotating the arm of the anchor relative to an axis of the catheter so that the arm extends along a desired contour; and

applying tension along the insertion path to the anchor so as to urge the wall of the second ventricle proximally against the septal wall along the contour.

17. The method of claim 16 further comprising advancing a guidewire through the lumen of the catheter and through the septal wall, and

advancing the guidewire through the lumen of the catheter and through the second wall.

18. The method of claim 17 wherein the catheter and/or the guidewire emits electrosurgical energy to perforate the septal wall and the wall of the second ventricle, and wherein the catheter is advanced over the guidewire.

19. The method of claim 16 wherein the distal tip of the catheter is curved by a catheter bending mechanism when the making the first perforation so that the catheter within the first ventrical bends away from the septum and back toward the septum.

20. The method of claim 16 further comprising positioning the catheter so that the distal tip faces the septum prior to making the first perforation on the septum, and positioning the catheter so that the distal tip faces the wall of the second ventricle prior to making the second perforation on the septum.

21. The method of claim 16 further comprising:

retracting the distal tip of the catheter into the first ventricle from the epicardial space and the second ventricle;

making a third perforation on the on the septal wall, the third perforation on the septal wall being adjacent to the first perforation on the septal wall;

advancing the distal tip of the catheter of through the third perforation into the second ventricle;

making a fourth perforation on the wall of the second ventricle, the fourth perforation being adjacent to the second perforation on the wall of the second ventricle;

inserting a second anchor distally of the wall of the second ventricle through the third and fourth perforations and deploying the anchor laterally along a contour extending between the anchors; and

applying tension along the second insertion path to the second anchor so as to urge the wall of the second ventricle proximally against the septal wall along the contour.

22. The method of claim 16 further comprising stabilizing the distal tip of the catheter relative to the septal wall prior to making the first perforation, and stabilizing the distal tip of the catheter relative to the wall of the second ventricle prior to making the second perforation, wherein stabilizing the catheter comprises applying suction through a suction lumen of the catheter.

23. A system for treating a heart of a patient, the heart having a chamber bordered by a plurality of walls, the system comprising:

a tubular body having a lumen extending along an axis to a distal end, the tubular body accommodating a bend in the axis;

a first anchor advanceable through a first wall of the heart within the lumen, the first anchor having an elongate arm deployable from an insertion configuration suitable for insertion of the first anchor within the lumen to a deployed configuration, the elongate arm having a first stiffness in a first orientation so as to accommodate the bend in the tubular body, the arm having a second stiffness in a second orientation, the second stiffness greater than the first orientation so as to inhibit deflection of the arm away from the wall when deployed distally of a wall of the heart and proximal tension is applied to pull the heart wall proximally.

25. The assembly of claim 23, wherein the proximal anchor arm system comprises a first proximal anchor arm having a first adhesive region and an aperture adapted to be advanced and secured over a first of the tension members;

and

a second proximal anchor arm having a second adhesive region and an aperture adapted to be advanced and secured over a second tension member;

wherein the first adhesive region of the first proximal anchor and the second adhesive region of the second proximal anchor adhere to each other when in contact.

24. An assembly for treating a heart of a patient, the assembly comprising:

at least two elongate tension members;

at least two distal anchor assemblies, each distal anchor assembly comprising an elongate arm deployable laterally from the tension member after insertion distally through a heart wall and coupleable to the distal end of an associated tension member so as draw the anchors and a wall of the heart proximally; and

a proximal anchor arm system having at least two apertures adapted to be advanced distally over the tension members and to inhibit proximal movement of the proximal anchor relative to the tension members while engaging the heart throughout a contour extending between the tension members.

26. An anchor assembly for treating a heart of a patient, the assembly comprising:

an elongate shaft having a proximal end and a distal end; and

an expandable member coupled to the distal end of the elongate shaft, the expandable member comprising a wire which can resiliently expand into a deployed, expanded form.

27. An anchor assembly for treating a heart of a patient, the assembly comprising:

an elongate shaft having a proximal end and a distal end; and

an expandable member coupled to the distal end of the elongate shaft, the expandable member comprising a plurality of segments coupled to each other by articulated hinges, the plurality of segments having a low profile, undeployed configuration and a high profile, deployed configuration.

28. A tether cutting device comprising:

a first elongate shaft having a proximal end, a distal end, and a central lumen;

at least one cutting member extending outward from the distal end of the first elongate shaft, the at least one cutting member having an inwardly facing cutting edge; and

a second elongate shaft having a proximal end and a distal end, the second elongate shaft axially translatable over the first elongate shaft,

wherein the distal end of the second elongate shaft pushes the at least one cutting member inward to cut a tether passed through the lumen of the first elongate shaft as the second elongate shaft is advanced distally.

29. The tether cutting device of claim 28 further comprising a distal cap coupled to the distal end of the first elongate shaft and the distal end of the second elongate shaft, the distal cap having an aperture for passing a tether therethrough.

30. A tether cutting device comprising:

an elongate shaft having a proximal end, a distal end, a central lumen, and at least one elongate arm extending distally from the distal end of the elongate shaft; and

a distal cap disposed over and axially translatable over the distal end of the elongate shaft, the distal cap having an aperture and comprising at least one blade facing inward and disposed on an interior side of the distal cap,

wherein the at least one elongate arm of the elongate shaft pushes the at least one cutting member inward to cut a tether passed through the lumen of the elongate shaft as the distal cap is retracted proximally.

31. A tether cutting device comprising:

an elongate tubular shaft having a central lumen and a distal aperture;

at least one cutting member disposed on an inner side of the elongate tubular shaft;

at least one elongate member coupled to the at least one cutting member, wherein proximal retraction of the at least one elongate member pulls the at least one cutting member inward to cut a tether passed through the distal aperture and central lumen of the elongate tubular shaft.

32. A method for directing a distal end of a flexible catheter tube, the method comprising:

encompassing a proximal portion of the catheter tube within a sheath, the sheath defining an orientation axis and having at least one distal arm extending from its distal end;

securing the distal end of the catheter within a tubular member, the tubular member being coupled to at least one distal arm through an articulated hinge; and

distally advancing a portion of the proximal portion of the catheter tube out of the sheath such that the advanced portion of the catheter tube bends relative to the orientation axis due to the tubular member barring distal advancement of the catheter tube out of the tubular member.