LOCATION, TIME, AND/OR PRESSURE DETERMINING DEVICES, SYSTEMS, AND METHODS FOR DEPLOYMENT OF LESION-EXCLUDING HEART IMPLANTS FOR TREATMENT OF CARDIAC HEART FAILURE AND OTHER DISEASE STATES

• US 20080294251A1
• Filed: 05/21/2007
• Published: 11/27/2008
• Est. Priority Date: 09/28/2006
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Bertolero, Arthur A., Swanson, David K., Annest, Lon S.
• Granted Patent: US 9,211,115 B2
• Time in Patent Office: Days
• US Class Current: 623/3.1
• 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 17/0401 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• 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 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/2484 Delivery devices therefor

Abstract

Devices, systems, and methods for treating a heart of a patient may make use of structures which limit a size of a chamber of the heart, such as by deploying one or more tensile member to bring a wall of the heart and a septum of the heart into contact. A plurality of tension members may help exclude scar tissue and provide a more effective remaining ventricle chamber. The implant may be deployed during beating of the heart, often in a minimally invasive or less-invasive manner. Trauma to the tissues of the heart may be inhibited by selectively approximating tissues while a pressure within the heart is temporarily reduced. Three-dimensional implant locating devices and systems facilitate beneficial heart chamber volumetric shape remodeling.

Claims

1. A method for treating a heart, the method comprising:

decreasing, during beating of the heart, a distance between a first location bordering a chamber of the heart and a second location bordering the chamber of the heart, wherein the distance is selectively decreased while a pressure within the chamber is temporarily reduced so as to permanently and safely reduce a volume of the chamber.

2. The method of claim 1, wherein beating of the heart induces a systolic pressure, and wherein the distance between the first location and the second location is selectively and permanently decreased while the pressure within the chamber is less than the systolic pressure.

3. The method of claim 2, further comprising:

coupling a first anchor with the first location along the chamber;

coupling a second anchor with the second location along the chamber;

approximating the first and second locations of the chamber by applying tension between the first anchor and the second anchor that is sufficient to reduce the distance during diastolic pressure but is not sufficient to reduce the distance during the systolic pressure.

4. The method of claim 3, wherein the tension is applied intermittently during beating of the heart by incrementally decreasing between systolic pressure peaks, a length of a tension member extending between a first anchor coupled to the first location and a second anchor coupled to the second location.

5. The method of claim 4, wherein beating of the heart induces a diastolic pressure, and wherein the tension is selectively and intermittently applied when the pressure in the chamber is closer to the diastolic pressure than the systolic pressure, and wherein the tension is not increased during the systolic pressure peaks.

6. The method of claim 2, further comprising inhibiting blood flow into the chamber so as to temporarily decrease pressure within the chamber, and selectively reducing the distance while the pressure is decreased.

7. The method of claim 6, wherein the blood flow into the chamber is inhibited by introducing a balloon catheter into a blood path flowing toward the chamber, and expanding a balloon of the balloon catheter so that the balloon inhibits the blood flow.

8. The method of claim 3, further comprising pacing the heart so as to limit heart-induced pressure in the chamber.

9. The method of claim 1, further comprising decreasing a plurality of laterally off-set separation distances between a first plurality of anchors and a second plurality of anchors, the first and second pluralities of anchors being coupled to the heart, and wherein the decreasing of the separation distances effectively excludes scar tissue of the heart from the chamber so as to mitigate congestive heart failure (CHF) of the heart.

10. The method of claim 9, wherein at least some of the separation distances are reduced simultaneously.

11. The method of claim 9, wherein at least some of the separation distances are reduced sequentially.

12. The method of claim 1, wherein the treatment is performed in a minimally invasive manner.

13. The method of claim 1, wherein the distance is decreased using a plurality of anchors that penetrate scar tissue of the heart.

14. The method of claim 13, further comprising characterizing the scar tissue by applying pacing signals adjacent candidate anchor locations so as to avoid penetrating viable contractile tissues with the anchors.

15. A method for treating a diseased heart, the method comprising:

reducing, in a first cross-section, a first size of a chamber of a heart by approximation of a first anchor location toward a second anchor location, the anchor locations disposed near edges of a diseased tissue bordering the chamber;

determining, for a second cross-section, a second reduction in size of the chamber, the second reduction in size being determined in response to;

an offset between the first cross-section and the second cross-section, and

a magnitude of the first reduction in cross-section of the chamber; and

effecting the determined second reduction in size of the chamber by deploying third and fourth anchors into tissues of the heart bordering the chamber, and by reducing a length of a tension member extending between the third and forth anchors.

16. The method of claim 15, wherein the magnitude of the first reduction in cross-section is identified from a length of a body extending between locations of the first anchor and the second anchor.

17. The method of claim 16, wherein the chamber in the first cross section has a first cross-section diameter defining a first curvature, wherein the body has an axis between the first anchor and the second anchor, the axis having an axis curvature substantially corresponding to the first curvature, the magnitude of the first reduction in cross-section determined by measuring the length of the curving axis between the first anchor location and the second anchor location, approximation of the first and second anchors effecting a change from the first diameter to a first reduced diameter.

18. The method of claim 15, wherein a magnitude of the second reduction in cross-section is identified from a length of a body extending between locations of the third anchor and the fourth anchor.

19. The method of claim 18, wherein the chamber in the second cross section has a second cross-section diameter defining a second curvature, wherein the body has an axis between the third anchor and the fourth anchor, the axis having an axis curvature substantially corresponding to the second curvature, the magnitude of the second reduction in cross-section determined by the length of the curving axis between the third anchor location and the fourth anchor location, approximation of the third and fourth anchors effecting a change from the second diameter to a first reduced diameter.

20. The method of claim 15, further comprising determining the second reduction in size in response to a diseased size of the chamber in the second cross section before the second reduction.

21. The method of claim 20, wherein the second reduction in size is determined by computing a change in length of a circumference of the second cross section from a desired change in diameter of the second cross section.

22. The method of claim 15, further comprising determining, for each of a plurality of cross-sections, an associated desired reduction in size of the chamber, the associated reduction in size being determined in response to:

a diseased size of the chamber in the cross-section before the associated reduction,

an offset between the first cross-section and the cross-section, and

a magnitude of the first reduction,

so as to define a desired volumetric shape of the chamber; and

effecting each determined reduction in size of the chamber by deploying associated anchors into tissues of the heart bordering the chamber, and by reducing a length of a tension member extending between the anchors to generate the desired volumetric shape of the chamber.

23. A method for treating a diseased heart, the method comprising:

aligning an anchor pattern template with a chamber of the heart, the anchor pattern template identifying a plurality of anchor locations;

deploying a plurality of anchors into tissue of the heart per the aligned template; and

applying, between associated anchors, tension so as to approximate tissue adjacent the associated anchors and reduce an effective size of the chamber.

24. The method of claim 23, further comprising inserting the anchor pattern template into the chamber in a small-profile configuration and expanding the anchor pattern template to a large-profile configuration within the chamber.

25. The method of claim 23, wherein the anchor pattern template is aligned with scar tissue of the heart, and wherein the desired volumetric shape excludes the scar tissue from the chamber.

26. A system for treating a heart, the system comprising:

a first anchor for coupling to a first location bordering a chamber of the heart;

a second anchor for coupling to a second location bordering the chamber of the heart;

a tension member coupling the first anchor with the second anchor, the tension member configured to be selectively shortened in situ from an elongate configuration to a shortened configuration; and

a heart stress limiting component configured to be operatively coupled to the heart to facilitate selectively shortening of the tension member to reduce a size of the chamber while the heart is beating and pressure within the chamber is temporarily reduced.

27. The system of claim 26, wherein the tension member in the shortened configuration provides a permanent decrease in separation between the first anchor and the second anchor, and wherein the pressure component in configured to limit the pressure within the chamber to less than systolic pressure during the shortening.

28. The system of claim 27, wherein the component generates a tension force in the tension member that is sufficient to appropriate the locations between systolic pressure peaks, and wherein the tension member has a plurality of intermediate configurations so that the tension member can be shortened intermittently during beating of the heart by incrementally decreasing a length of a tension member extending between the first anchor and the second anchor between the systolic pressure peaks.

29. The system of claim 27, wherein the pressure component comprises a balloon catheter having a balloon configured for expanding within a blood path flowing toward the chamber so as to temporarily decrease pressure within the chamber.

30. The system of claim 26, further comprising decreasing a plurality of associated anchor pairs and tension members, each tension member coupleable to the associated anchors of the pair and being configured for selectively decreasing of separation distances between the anchors of the pair so as to effectively exclude a scar tissue of the heart from the chamber and mitigate congestive heart failure (CHF) of the heart.

31. The system of claim 26, further comprising a minimally invasive catheter system releasably receiving the anchors and tension member for deployment in the heart in a minimally invasive manner.

32. The system of claim 26, wherein the pressure component comprises a pacing catheter.

33. A system for treating a diseased heart, for use with:

a first implant set including a first anchor for coupling to a first location bordering a chamber of the heart, a second anchor for coupling to a second location bordering the chamber of the heart, and a first tension member for coupling the first anchor with the second anchor, the first implant suitable for reducing, in a first cross-section, a first size of the chamber of the heart by approximation of the first anchor location toward the second anchor location;

a second implant set including a third anchor for coupling to a third location bordering the chamber of the heart, a fourth anchor for coupling to a fourth location bordering the chamber of the heart, and a second tension member for coupling the third anchor with the fourth anchor, the second implant set suitable for reducing, in a second cross-section, a second size of the chamber of the heart by approximation of the third anchor location toward the fourth anchor location;

the system comprising;

a processor configured for determining, for the second cross-section, the second reduction in size of the chamber, the second reduction in size being determined in response to;

an offset between the first cross-section and the second cross-section, and

a magnitude of the first reduction in cross-section of the chamber.

34. The system of claim 33, further comprising the first anchor set and the second anchor set.

35. A system for diagnosing or treating a diseased heart, a chamber of the heart having a diameter defining a curvature between a first location and a second location, the system comprising:

a body extendable from the first location to the second location, the body having an axis with an axis curvature substantially corresponding to the curvature of the chamber so that a curving length of the body between the locations approximates a circumference of the wall between the locations.

36. The system of claim 35, further comprising a plurality of anchor pairs and associated tension members for approximating heart tissues and a processor configured for determining, for a plurality of cross-sections, an associated treatment of the chamber, the associated treatment comprising a reduction in size and being determined in response to:

a diseased size of the chamber in the cross section before the treatment,

an offset between the cross-sections, and

a magnitude of a first reduction,

so as to define a desired volumetric shape of the chamber.

37. A device for treating a diseased heart, the device for use with a plurality of anchors, the device comprising an anchor pattern template for aligning with a chamber of the heart, the anchor pattern template comprising indicia identifying a plurality of anchor locations such that when the anchor pattern template is aligned with the chamber, the plurality of anchors are deployed into tissue of the heart per the aligned indicia, and tension is applied between deployed anchors so as to approximate the tissue, an effective size of the chamber is reduced.

38. The device of claim 37, wherein the anchor pattern template has a small profile configuration for insertion into the chamber, and wherein the anchor pattern template is expandable in situ to a large-profile configuration within the chamber for alignment of the anchors therewith.

39. The device of claim 37, the heart having scar tissue along the chamber, wherein the anchor pattern template is alignable with the scar tissue of the heart so that when the anchor are deployed per the indicia and the tissue is approximated a desired volumetric shape of the chamber is generated, the desired shape excluding the scar tissue from the chamber.