Devices, systems, and methods for reshaping a heart valve annulus

• US 10,278,818 B2
• Filed: 12/12/2016
• Issued: 05/07/2019
• Est. Priority Date: 12/10/2015
• Status: Active Grant

• Current Assignee: MVRx, Inc.
• Original Assignee: MVRx, Inc.
• Inventors: Machold, Timothy R., Rahdert, David A., Chang, Robert T., Manoharan, Ganesh
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/376,418
• Publication Number:
  US 20170165068A1
• Time in Patent Office: 876 Days
• Field of Search: 623 237- 238
• 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 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-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: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body

Abstract

Anchors for securing an implant within a body organ and/or reshaping a body organ are provided herein. Anchors are configured for deployment in a body lumen or vasculature of the patient that are curved or conformable to accommodate anatomy of the patient. Such anchors can include deformable or collapsible structures upon tensioning of a bridging element in a lateral direction, or segmented tubes that can be adjusted by tightening of one or more tethers extending therethrough. Such anchors can be used as a posterior anchor in a blood vessel in implant systems having a tensioned bridging element extending between the posterior anchor and an anterior anchor deployed at another location within or along the body organ. Methods of deploying such anchors, and use of multiple anchors or multiple bridging elements to a single anchor are also provided.

Claims

1. An anchor for securing an implant within a body organ for reshaping of a body organ of a patient, the anchor comprising:

a substantially cylindrical body that is sized and dimensioned for delivery and deployment in a body lumen or blood vessel of the patient, the cylindrical body being deformable or collapsible in a lateral direction; and

a substantially rigid backbone extending longitudinally along at least a portion of the cylindrical body, the substantially rigid backbone being disposed on or within the cylindrical body,

wherein the backbone includes an attachment region along an intermediate portion thereof for coupling with a bridging element of the implant,

wherein the cylindrical body is configured such that when the bridging element is coupled to the attachment region and tensioned while the anchor is disposed within the body lumen or blood vessel, the backbone deforms or collapses the cylindrical body,

wherein the backbone is longitudinally curved so as to conform to anatomy of the patient.

2. The anchor of claim 1, wherein the substantially cylindrical body is configured to engage 180 degrees or less of an inner wall of the body lumen or blood vessel when laterally deformed or collapsed.

3. The anchor of claim 1, wherein the anchor is an intravascular anchor sized and dimensioned for delivery and deployment within a blood vessel of the patient.

5. The anchor of claim 1, wherein the cylindrical body comprises an expandable scaffold having an expanded configuration in which the scaffold circumferentially engages the blood vessel and a laterally collapsed configuration in which scaffold collapses into a C-shape so as to engage at least a portion of one side of the blood vessel when the bridging element is tensioned.

6. The anchor of claim 5, wherein the expandable scaffold further comprises a radially compressed configuration to facilitate intravascular delivery through the blood vessel.

9. An implant system for treating a human heart valve, the system comprising:

an anterior anchor configured to positioned within a desired location along or within an organ of the patient;

a posterior anchor comprising the anchor of claim 1; and

a bridging element adapted to span a chamber of the heart between an anterior anchor and a posterior anchor and maintain sufficient tension therebetween so as to provide a desired spacing between the anterior anchor and posterior anchor thereby reshaping the chamber of the heart so as to improve function of the heart valve.

4. An anchor for securing an implant within a body organ for reshaping of a body organ of a patient, the anchor comprising:

a substantially cylindrical body that is sized and dimensioned for delivery and deployment in a body lumen or blood vessel of the patient, the cylindrical body being deformable or collapsible in a lateral direction; and

a substantially rigid backbone extending longitudinally along at least a portion of the cylindrical body, the substantially rigid backbone being disposed on or within the cylindrical body,

wherein the backbone includes an attachment region along an intermediate portion thereof for coupling with a bridging element of the implant,

wherein the cylindrical body is configured such that when the bridging element is coupled to the attachment region and tensioned while the anchor is disposed within the body lumen or blood vessel, the backbone deforms or collapses the cylindrical body,

wherein the cylindrical body comprises a plastically compressible foam material so as to increase a contact surface of the cylindrical body against the wall of the blood vessel or organ.

7. An anchor for securing an implant within a body organ for reshaping of a body organ of a patient, the anchor comprising:

a substantially cylindrical body that is sized and dimensioned for delivery and deployment in a body lumen or blood vessel of the patient, the cylindrical body being deformable or collapsible in a lateral direction; and

a substantially rigid backbone extending longitudinally along at least a portion of the cylindrical body, the substantially rigid backbone being disposed on or within the cylindrical body,

wherein the backbone includes an attachment region along an intermediate portion thereof for coupling with a bridging element of the implant,

wherein the cylindrical body is configured such that when the bridging element is coupled to the attachment region and tensioned while the anchor is disposed within the body lumen or blood vessel, the backbone deforms or collapses the cylindrical body,

wherein the cylindrical body comprises an expandable scaffold having an expanded configuration in which the scaffold circumferentially engages the blood vessel and a laterally collapsed configuration in which scaffold collapses into a C-shape so as to engage at least a portion of one side of the blood vessel when the bridging element is tensioned,

wherein the expandable scaffold comprises folding zones extending longitudinally on opposite sides of the scaffold and offset from the backbone so as to facilitate lateral collapse when a lateral force is applied to the backbone.

8. An anchor for securing an implant within a body organ for reshaping of a body organ of a patient, the anchor comprising:

a substantially cylindrical body that is sized and dimensioned for delivery and deployment in a body lumen or blood vessel of the patient, the cylindrical body being deformable or collapsible in a lateral direction; and

a substantially rigid backbone extending longitudinally along at least a portion of the cylindrical body, the substantially rigid backbone being disposed on or within the cylindrical body,

wherein the backbone includes an attachment region along an intermediate portion thereof for coupling with a bridging element of the implant,

wherein the cylindrical body is configured such that when the bridging element is coupled to the attachment region and tensioned while the anchor is disposed within the body lumen or blood vessel, the backbone deforms or collapses the cylindrical body,

wherein the cylindrical body comprises an expandable scaffold having an expanded configuration in which the scaffold circumferentially engages the blood vessel and a laterally collapsed configuration in which scaffold collapses into a C-shape so as to engage at least a portion of one side of the blood vessel when the bridging element is tensioned,

wherein the expandable scaffold is a mesh cylinder, the mesh being adapted to facilitate in-growth of adjacent tissue.

10. An anchor for securing an implant within a body lumen for reshaping of a body organ of a patient, the anchor comprising:

an elongate main body being curved or conformable so as to accommodate an anatomy of the patient, wherein the elongate main body is hollow to facilitate delivery via a guidewire or catheter; and

an anti-flipping feature adapted to resist flipping or inversion of the elongate main body when a bridging element attached to the main body is tensioned along a direction of curvature of the elongate main body.

11. The anchor of claim 10, wherein the anchor further comprises:

a substantially rigid elongate support member with an attachment region on an intermediate portion thereof for coupling with the bridging element,

wherein the elongate main body comprises a jacket configured to cover at least a portion of the elongate support member, the jacket being formed of a flexible material and extending beyond each opposite end of the elongate support member to provide atraumatic tips.

12. The anchor of claim 11, wherein the anti-flipping feature comprises a shape of the jacket, wherein the shape of the jacket includes a planar central portion that is wider than each opposing end portion of the jacket to provide an increased contact area for engagement with the lumen and an attachment region within the planar central portion to allow attachment of a bridging element to the support member.

13. The anchor of claim 10, wherein the anti-flipping feature comprises a substantially rigid link pivotally coupled to an intermediate portion of the curved elongate main body and pivotally movable along a plane of curvature of the elongate so as to be foldable against the elongate main body during delivery and laterally extended from the main body when deployed.

14. An anchor for securing an implant within a body lumen for reshaping of a body organ of a patient, the anchor comprising:

an elongate main body being transformable from a substantially linear configuration to a curvilinear configuration to accommodate an anatomy of the patient, wherein the elongate main body comprises a plurality of segments having an interior lumen extending therethrough, and

one or more tethers extending through an interior of the elongate main body that are engaged with opposite end portions of the elongate main body such that tensioning of the one or more tethers in a lateral direction draws the plurality of segments together thereby curving the main body in the direction along which the one or more tethers are tensioned,

wherein the elongate main body is a single hollow tube that is segmented by a plurality of kerfs distributed along a length of the single tube.

15. An anchor for securing an implant within a body lumen for reshaping of a body organ of a patient, the anchor comprising:

an elongate main body being transformable from a substantially linear configuration to a curvilinear configuration to accommodate an anatomy of the patient, wherein the elongate main body comprises a plurality of segments having an interior lumen extending therethrough, and

one or more tethers extending through an interior of the elongate main body that are engaged with opposite end portions of the elongate main body such that tensioning of the one or more tethers in a lateral direction draws the plurality of segments together thereby curving the main body in the direction along which the one or more tethers are tensioned,

wherein the one or more tethers comprise first and second tethers coupled with opposite ends of the main body, respectively, and exiting through one or more openings in a center portion of the main body such that the main body assumes a curved shape when the ends of the main body are forced inward by tensioning of the first and second tethers.

16. An anchor for securing an implant within a body lumen for reshaping of a body organ of a patient, the anchor comprising:

an elongate main body being transformable from a substantially linear configuration to a curvilinear configuration to accommodate an anatomy of the patient, wherein the elongate main body comprises a plurality of segments having an interior lumen extending therethrough, and

one or more tethers extending through an interior of the elongate main body that are engaged with opposite end portions of the elongate main body such that tensioning of the one or more tethers in a lateral direction draws the plurality of segments together thereby curving the main body in the direction along which the one or more tethers are tensioned,

wherein the one or more tethers comprise a single tether extending directly from one end of the main body and secured to the other end of the main body by a fastener, the tether shortened to a length at which the main body assumes a desired radius of curvature for deployment.

17. The anchor of claim 16, wherein the one or more tethers comprises a tether that extends through an interior lumen of the main body and exits from opposite end portions of the main body for attachment to another anchor, either directly or through a bridging element, such that tensioning of the tether draws the opposite end portions together thereby curving the main body.

18. An anchor for securing an implant within a body lumen for reshaping of a body organ of a patient, the anchor comprising:

an elongate main body being transformable from a substantially linear configuration to a curvilinear configuration to accommodate an anatomy of the patient, wherein the elongate main body comprises a plurality of segments having an interior lumen extending therethrough, and

one or more tethers extending through an interior of the elongate main body that are engaged with opposite end portions of the elongate main body such that tensioning of the one or more tethers in a lateral direction draws the plurality of segments together thereby curving the main body in the direction along which the one or more tethers are tensioned,

wherein the main body comprises a plurality of independent segments having interfacing ends that are angled to facilitate curvature of the main body when the one or more tethers are tensioned.

19. An anchor for securing an implant within a body lumen for reshaping of a body organ of a patient, the anchor comprising:

an elongate main body being transformable from a substantially linear configuration to a curvilinear configuration to accommodate an anatomy of the patient, wherein the elongate main body comprises a plurality of segments having an interior lumen extending therethrough, and

one or more tethers extending through an interior of the elongate main body that are engaged with opposite end portions of the elongate main body such that tensioning of the one or more tethers in a lateral direction draws the plurality of segments together thereby curving the main body in the direction along which the one or more tethers are tensioned,

wherein the plurality of segment comprises a plurality of hollow tubular segments.

20. An anchor for securing an implant within a body lumen for reshaping of a body organ of a patient, the anchor comprising:

an elongate main body being transformable from a substantially linear configuration to a curvilinear configuration to accommodate an anatomy of the patient, wherein the elongate main body comprises a plurality of segments having an interior lumen extending therethrough, and

one or more tethers extending through an interior of the elongate main body that are engaged with opposite end portions of the elongate main body such that tensioning of the one or more tethers in a lateral direction draws the plurality of segments together thereby curving the main body in the direction along which the one or more tethers are tensioned,

wherein the plurality of segments comprises a string of interfacing elements, each element being formed of any suitable material and shape.