IP Library › Granted Patent US 12,433,749
Granted Patent B2
US 12,433,749 · App. 18/782,496 · Granted Oct 7, 2025

Systems, devices, and methods for reducing heart valve regurgitation

Inventor: Sai Muralidhar Padala (Atlanta, GA)
Assignee: Emory University
A61F2/246A61F2/2457A61F2/2463A61F2/2466A61F2002/0081A61F2220/0008A61F2220/0075A61F2230/0006A61F2230/0069A61F2250/0098
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Quick Facts
Patent No.
US 12,433,749
App. No.
18/782,496
Granted
Oct 7, 2025
Kind
B2
Abstract

Embodiments described herein relate to an implant delivery system for delivering an implant for reducing heart valve regurgitation. The implant delivery system may include an implant catheter disposed in an inner lumen of a guide catheter. The implant catheter may include one or more hypotubes disposed therein, each hypotube configured to receive an elongate member such as a braided tether. A distal end of the implant catheter may be coupled to an implant holder configured to receive the implant. The implant holder may define one or more channels, each channel configured to receive a portion of a respective elongate member. The elongate members configured to couple the implant to the implant holder and transition the implant between configurations. The implant configured to be disposed around a portion of a leaflet of a heart valve to improve coaptation of the heart valve.

Claims (176)

1. A method of reducing heart valve regurgitation, comprising:

advancing an implant in a delivery configuration to a heart valve via a delivery device, the implant comprising a first arm, a second arm and a plurality of support members each extending from the first arm to a respective free end and being in a curved and elongated state when the implant is in the delivery configuration;

separating the first and second arms by applying tension to a tether routed through at least one of a plurality of holes (1) of the first arm, or (2) of the second arm;

positioning the first arm on a first side of a native leaflet of the heart valve and the second arm on a second, opposite side of the native leaflet of the heart valve; and

releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve.

2. The method of claim 1 , further comprising determining a position of the implant via a radiopaque marker coupled to the first arm or the second arm.

3. The method of claim 1 , wherein releasing at least one of the first and second arms comprises reducing the tension applied to the tether routed through at least one of the plurality of holes of the first arm or the second arm.

4. The method of claim 1 , wherein the first and second arms may be separated by applying a separation force of about 150 mN to about 600 mN to the first and second arms.

5. The method of claim 1 , further comprising removing the implant from the heart valve.

6. The method of claim 1 , further comprising,

after releasing the first and second arms to couple the implant to the heart valve, repositioning the implant relative to the heart valve.

7. The method of claim 6 , wherein repositioning the implant comprises separating the first and second arms a second time, moving the implant relative to the heart valve, and releasing the first and second arms a second time to recouple the implant to the heart valve.

8. The method of claim 1 , further comprising selecting the implant from a plurality of implants.

9. The method of claim 1 wherein the heart valve is selected from the group consisting of a mitral valve, a tricuspid valve, an aortic valve, and a pulmonary valve.

10. The method of claim 1 , wherein the implant is configured to nondestructively couple to the heart valve.

11. The method of claim 1 , wherein the advancing an implant in the delivery configuration to the heart valve via the delivery device includes:

inserting a steerable guide catheter having an implant catheter slidably and rotatably disposed therein through a vasculature of a patient such that a distal end of the steerable guide catheter is disposed in an atrium of the heart, the implant being in a closed position and removably coupled to a distal end portion of the implant catheter during the inserting; and

with the guide catheter disposed in the atrium, advancing the implant catheter relative to the guide catheter to expose the implant within the atrium.

12. The method of claim 11 , further comprising:

with the guide catheter disposed within the atrium and the implant catheter advanced to expose the implant from the guide catheter, steering and rotating the implant catheter relative to the guide catheter to align the implant with the native leaflet.

13. The method of claim 11 , wherein the tether is a first tether, separating the first and second arms includes:

applying tension to the first tether that is removably coupled to the first arm; and

after applying tension to the first tether, applying tension to a second tether that is removably coupled to the second arm.

14. The method of claim 13 , wherein the releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve includes:

releasing the tension applied to at least one of the first tether or the second tether.

15. The method of claim 14 , further comprising:

after the releasing the tension and with the first tether removably coupled to the first arm and with the second tether removably coupled to the second arm, partially withdrawing the implant catheter away from the implant and native leaflet to visualize the implant's impact on coaptation of the native heart valve.

16. The method of claim 13 , wherein the first tether forms a first loop at a first end thereof that is removably coupleable to the first arm, and the second tether forms a second tether loop at a first end thereof that is removably coupleable to the second arm.

17. The method of claim 16 , further comprising:

releasing the first tether loop and pulling a second end of the first tether proximally until the first end of the first tether is decoupled from the first arm of the implant; and

releasing the second tether loop and pulling a second end of the second tether proximally until the first end of the second tether is decoupled from the second arm of the implant.

18. The method of claim 15 , further comprising:

withdrawing the implant catheter and the guide catheter with the implant coupled to the one or more of a native leaflet or chordae tendineae of the heart valve.

19. The method of claim 13 , wherein the implant catheter defines a single lumen and housing, within the single lumen, four elongate members each defining a lumen therethrough, wherein

the first tether extends through a first elongate member and a second elongate member of the four elongate members such that tension applied to both free ends of the first tether applies tension to the first arm, and

the second tether extends through a third elongate member and a fourth elongate member of the four elongate members such that tension applied to both free ends of the second tether applies tension to the second arm.

20. The method of claim 1 , wherein the first side of the native leaflet faces an atrium of a heart of a patient, a second side of the native leaflet faces a ventricle of the heart of the patient.

21. The method of claim 1 , wherein the delivery device includes an implant holder at a distal end thereof configured to hold the implant, the implant holder including a flat surface and a cavity distal to the flat surface, at least a portion of the first arm and a portion of the second arm are configured to abut the flat surface of the implant holder when the implant is in the delivery configuration, the plurality of support members are configured to be disposed in the cavity of the implant holder when the implant is in the delivery configuration.

22. The method of claim 1 , wherein the implant further includes a cover disposed around the plurality of support members, the plurality of support members and the cover collectively provide a coaptation surface.

23. The method of claim 1 , wherein the advancing the implant in the delivery configuration to the heart valve via the delivery device includes:

navigating the delivery device from a right atrium, across an atrial septum, through a left atrium to position the implant relative to the native leaflet of the heart valve.

24. A method of reducing heart valve regurgitation, comprising:

advancing an implant in a delivery configuration to a heart valve via a delivery device, the implant comprising a first arm, a second arm and a plurality of support members each extending from the first arm to a respective free end;

separating the first and second arms by applying a separation force of about 150 mN to about 600 mN to the first and second arms;

positioning the first arm on a first side of a native leaflet of the heart valve and the second arm on a second, opposite side of the native leaflet of the heart valve; and

releasing at least one of the first and second arms to couple the implant to one or more of the native leaflet or chordae tendineae of the heart valve, wherein, when coupled to the heart valve, a plurality of friction elements of the first arm and a plurality of friction elements of the second arm each engages the native leaflet of the heart valve.

25. The method of claim 24 , wherein the separating the first and second arms includes:

applying tension to a first tether that is removably coupled to the first arm; and

after applying tension to the first tether, applying tension to a second tether that is removably coupled to the second arm.

26. The method of claim 24 , further comprising,

after releasing the first and second arms to couple the implant to the heart valve, repositioning the implant relative to the heart valve, the repositioning the implant comprises separating the first and second arms a second time, moving the implant relative to the heart valve, and releasing the first and second arms a second time to recouple the implant to the heart valve.

27. The method of claim 25 , wherein the delivery device includes an implant holder at a distal end thereof configured to hold the implant, the implant holder defining a first channel and a second channel, a portion of the first tether configured to extend through the first channel and a portion of the second tether configured to extend through the second channel.

28. The method of claim 24 , wherein the plurality of support members are in a curved and elongated state in the delivery configuration, the plurality of support members are configured to transition from a less curved and more elongated state to a more curved and less elongated, in which the plurality of support members expand outward, when the implant is advanced from the delivery device.

29. A method of reducing heart valve regurgitation, comprising:

advancing an implant in a delivery configuration to a heart valve via a delivery device, the implant comprising a first arm, a second arm and a plurality of support members each extending from the first arm to a respective free end;

separating the first and second arms;

positioning the first arm on a first side of a native leaflet of the heart valve and the second arm on a second, opposite side of the native leaflet of the heart valve;

releasing at least one of the first and second arms to couple the implant to one or more of the native leaflet or chordae tendineae of the heart valve; and

after releasing the first and second arms to couple the implant to the heart valve, repositioning the implant relative to the heart valve, the repositioning including separating the first and second arms a second time, moving the implant relative to the heart valve, and releasing the first and second arms a second time to recouple the implant to the heart valve.

30. The method of claim 29 , wherein the separating the first and second arms includes:

applying tension to a first tether that is removably coupled to the first arm; and

after applying tension to the first tether, applying tension to a second tether that is removably coupled to the second arm.

31. The method of claim 30 , wherein the releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve includes:

releasing the tension applied to at least one of the first tether or the second tether.

32. The method of claim 29 , wherein the delivery device includes an implant holder at a distal end thereof configured to hold the implant, the implant holder including a flat surface and a cavity distal to the flat surface, at least a portion of the first arm and a portion of the second arm are configured to abut the flat surface of the implant holder when the implant is in the delivery configuration, the plurality of support members are configured to be disposed in the cavity of the implant holder when the implant is in the delivery configuration.

33. A method of reducing heart valve regurgitation, comprising:

inserting a steerable guide catheter having an implant catheter slidably and rotatably disposed therein through a vasculature of a patient such that a distal end of the steerable guide catheter is disposed in an atrium of the heart;

with the guide catheter disposed in the atrium, advancing the implant catheter relative to the guide catheter to expose an implant within the atrium, the implant including a first arm, a second arm, and a plurality of support members each extending from the first arm to a respective free end;

applying tension to a first tether that forms a first loop at a first end thereof and that is removably coupled to the first arm;

after applying tension to the first tether, applying tension to a second tether that forms a second loop at a first end thereof and that is removably coupled to the second arm;

positioning the first arm on a first side of a native leaflet of the heart valve and the second arm on a second, opposite side of the native leaflet of the heart valve; and

releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve.

34. The method of claim 33 , further comprising:

releasing the first tether loop and pulling a second end of the first tether proximally until the first end of the first tether is decoupled from the first arm of the implant; and

releasing the second tether loop and pulling a second end of the second tether proximally until the first end of the second tether is decoupled from the second arm of the implant.

35. The method of claim 33 , wherein the implant catheter defines a single lumen and housing, within the single lumen, four elongate members each defining a lumen therethrough, wherein:

the first tether extends through a first elongate member and a second elongate member of the four elongate members such that tension applied to both free ends of the first tether applies tension to the first arm,

the second tether extends through a third elongate member and a fourth elongate member of the four elongate members such that tension applied to both free ends of the second tether applies tension to the second arm.

36. The method of claim 33 , wherein the implant catheter includes an implant holder at a distal end thereof configured to hold the implant, the implant holder including a flat surface and a cavity distal to the flat surface, at least a portion of the first arm and a portion of the second arm are configured to abut the flat surface of the implant holder, the applying tension to the first arm stabilizes the first arm against the flat surface of the implant holder.

37. The method of claim 33 , wherein the implant catheter includes an implant holder at a distal end thereof configured to hold the implant, the implant holder defining a first channel and a second channel, a portion of the first tether configured to extend through the first channel and a portion of the second tether configured to extend through the second channel.

38. The method of claim 33 , wherein applying tension to the first tether stabilizes the implant against a distal end of the implant catheter and applying tension to the second tether separates the first and second arms.

39. The method of claim 33 , wherein the repositioning the implant includes:

separating the first and second arms a second time by applying tension to at least one of the first tether or the second tether;

after the implant is decoupled from the native heart valve, applying tension to the first tether to restabilize the implant against a distal end of implant catheter; and

moving the implant relative to the heart valve.

40. The method of claim 33 , wherein the steerable guide catheter further includes a steerable delivery catheter slidably and rotatably disposed therein, the implant catheter being slidably and rotatably disposed in an inner volume of the steerable delivery catheter.

41. The method of claim 1 , wherein the tether is a first tether, the separating the arms includes:

applying tension to the first tether routed through at least one of the plurality of holes of the first arm; and

applying tension to a second tether routed through at least one of the plurality of holes of the second arm.

42. A method of reducing heart valve regurgitation, comprising:

advancing an implant in a delivery configuration to a heart valve via a delivery device, the implant comprising a first arm, a second arm and a plurality of support members each extending from the first arm to a respective free end, wherein a first planar portion of the first arm and a second planar portion of the second arm are coplanar in the delivery configuration;

separating the first and second arms by applying tension to a tether routed through at least one of a plurality of holes (1) of the first arm, or (2) of the second arm;

positioning the first arm on a first side of a native leaflet of the heart valve and the second arm on a second, opposite side of the native leaflet of the heart valve; and

releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve.

43. The method of claim 42 , wherein releasing at least one of the first and second arms comprises reducing the tension applied to the tether routed through at least one of the plurality of holes of the first arm or the second arm.

44. The method of claim 42 , wherein the advancing an implant in the delivery configuration to the heart valve via the delivery device includes:

inserting a steerable guide catheter having an implant catheter slidably and rotatably disposed therein through a vasculature of a patient such that a distal end of the steerable guide catheter is disposed in an atrium of the heart, the implant being in a closed position and removably coupled to a distal end portion of the implant catheter during the inserting; and

with the guide catheter disposed in the atrium, advancing the implant catheter relative to the guide catheter to expose the implant within the atrium.

45. The method of claim 44 , wherein the tether is a first tether, -separating the first and second arms includes:

applying tension to the first tether that is removably coupled to the first arm; and

after applying tension to the first tether, applying tension to a second tether that is removably coupled to the second arm.

46. The method of claim 45 , wherein the releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve includes:

releasing the tension applied to at least one of the first tether or the second tether.

47. The method of claim 46 , further comprising:

after the releasing the tension and with the first tether removably coupled to the first arm and with the second tether removably coupled to the second arm, partially withdrawing the implant catheter away from the implant and native leaflet to visualize the implant's impact on coaptation of the native heart valve.

48. A method of reducing heart valve regurgitation, comprising:

advancing an implant in a delivery configuration to a heart valve via a delivery device, the implant comprising a first arm, a second arm and a plurality of support members each extending from the first arm to a respective free end, the first arm including a plurality of friction elements, the second arm including a plurality of friction elements;

separating the first and second arms by applying tension to a tether routed through at least one of a plurality of holes (1) of the first arm, or (2) of the second arm;

positioning the first arm on a first side of a native leaflet of the heart valve and the second arm on a second, opposite side of the native leaflet of the heart valve; and

releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve such that the plurality of friction elements of the first arm and the plurality of friction elements of the second arm each engages the native leaflet of the heart valve.

49. The method of claim 48 , wherein releasing at least one of the first and second arms comprises reducing the tension applied to the tether routed through at least one of the plurality of holes of the first arm or the second arm.

50. The method of claim 48 , wherein the advancing an implant in the delivery configuration to the heart valve via the delivery device includes:

inserting a steerable guide catheter having an implant catheter slidably and rotatably disposed therein through a vasculature of a patient such that a distal end of the steerable guide catheter is disposed in an atrium of the heart, the implant being in a closed position and removably coupled to a distal end portion of the implant catheter during the inserting; and

with the guide catheter disposed in the atrium, advancing the implant catheter relative to the guide catheter to expose the implant within the atrium.

51. The method of claim 50 , wherein the tether is a first tether, -separating the first and second arms includes:

applying tension to the first tether that is removably coupled to the first arm; and

after applying tension to the first tether, applying tension to a second tether that is removably coupled to the second arm.

52. The method of claim 51 , wherein the releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve includes:

releasing the tension applied to at least one of the first tether or the second tether.

53. The method of claim 52 , further comprising:

after the releasing the tension and with the first tether removably coupled to the first arm and with the second tether removably coupled to the second arm, partially withdrawing the implant catheter away from the implant and native leaflet to visualize the implant's impact on coaptation of the native heart valve.

54. A method of reducing heart valve regurgitation by implanting an implant having a first arm, a second arm, and a plurality of support members each extending from the first arm to a respective free end, the method comprising:

inserting a steerable guide catheter having an implant catheter slidably and rotatably disposed therein through a vasculature of a patient such that a distal end of the steerable guide catheter is disposed in an atrium of the heart, the implant being in a closed position and removably coupled to a distal end portion of the implant catheter during the inserting;

with the guide catheter disposed in the atrium, advancing the implant catheter relative to the guide catheter to expose the implant within the atrium;

separating the first and second arms by applying tension to a tether routed through at least one of a plurality of holes (1) of the first arm, or (2) of the second arm to move the implant from the closed position to an open position;

positioning the first arm on a first side of a native leaflet of the heart valve and the second arm on a second, opposite side of the native leaflet of the heart valve; and

releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve.

55. The method of claim 54 , wherein the tether is a first tether, -separating the first and second arms includes:

applying tension to the first tether that is removably coupled to the first arm; and

after applying tension to the first tether, applying tension to a second tether that is removably coupled to the second arm.

56. The method of claim 55 , wherein the releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve includes:

releasing the tension applied to at least one of the first tether or the second tether.

57. The method of claim 56 , further comprising:

after the releasing the tension and with the first tether removably coupled to the first arm and with the second tether removably coupled to the second arm, partially withdrawing the implant catheter away from the implant and native leaflet to visualize the implant's impact on coaptation of the native heart valve.

58. The method of claim 54 , wherein a first planar portion of the first arm and a second planar portion of the second arm are coplanar in a delivery configuration.

59. A method of reducing heart valve regurgitation, comprising:

advancing an implant in a delivery configuration to a heart valve via a delivery device, the implant comprising a first arm, a second arm and a plurality of support members each extending from the first arm to a respective free end, the advancing including navigating the delivery device from a right atrium, across an atrial septum, through a left atrium to position the implant relative to a native leaflet of the heart valve;

determining a position of the implant via a radiopaque marker coupled to the first arm or the second arm;

separating the first and second arms by applying tension to a tether routed through at least one of a plurality of holes (1) of the first arm, or (2) of the second arm;

positioning the first arm on a first side of the native leaflet of the heart valve and the second arm on a second, opposite side of the native leaflet of the heart valve; and

releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve.

60. The method of claim 59 , wherein the implant further includes a cover disposed around the plurality of support members, the plurality of support members and the cover collectively provide a coaptation surface.

61. The method of claim 59 , wherein the plurality of support members are in a curved and elongated state in the delivery configuration.

62. A method of reducing heart valve regurgitation, comprising:

advancing an implant in a delivery configuration to a heart valve via a delivery device, the implant comprising a first arm, a second arm and a plurality of support members each extending from the first arm to a respective free end;

separating the first and second arms by (1) applying tension to a first tether routed through at least one of a plurality of holes of the first arm, and (2) applying tension to a second tether routed through at least one of a plurality of holes of the second arm;

positioning the first arm on a first side of a native leaflet of the heart valve and the second arm on a second, opposite side of the native leaflet of the heart valve; and

releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve.

63. The method of claim 62 , wherein the implant further includes a cover disposed around the plurality of support members, the plurality of support members and the cover collectively provide a coaptation surface.

64. The method of claim 62 , wherein the plurality of support members are in a curved and elongated state in the delivery configuration.

65. A method of reducing heart valve regurgitation, comprising:

inserting a steerable guide catheter having an implant catheter slidably and rotatably disposed therein through a vasculature of a patient such that a distal end of the steerable guide catheter is disposed in an atrium of the heart;

with the guide catheter disposed in the atrium, advancing the implant catheter relative to the guide catheter to expose an implant within the atrium, the implant including a first arm, a second arm, and a plurality of support members each extending from the first arm to a respective free end;

applying tension to a first tether that is removably coupled to the first arm, thereby stabilizing the implant against a distal end of the implant catheter;

after applying tension to the first tether, applying tension to a second tether that is removably coupled to the second arm, thereby separating the first and second arms;

positioning the first arm on a first side of a native leaflet of the heart valve and the second arm on a second, opposite side of the native leaflet of the heart valve; and

releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve.

66. The method of claim 65 , wherein the first tether forms a first loop at a first end thereof that is removably coupleable to the first arm, and the second tether forms a second tether loop at a first end thereof that is removably coupleable to the second arm, the method further comprising:

releasing the first tether loop and pulling a second end of the first tether proximally until the first end of the first tether is decoupled from the first arm of the implant; and releasing the second tether loop and pulling a second end of the second tether proximally until the first end of the second tether is decoupled from the second arm of the implant.

67. The method of claim 65 , wherein the implant catheter defines a single lumen and housing, within the single lumen, four elongate members each defining a lumen therethrough, wherein:

the first tether extends through a first elongate member and a second elongate member of the four elongate members such that tension applied to both free ends of the first tether applies tension to the first arm,

the second tether extends through a third elongate member and a fourth elongate member of the four elongate members such that tension applied to both free ends of the second tether applies tension to the second arm.

68. The method of claim 65 , wherein the tether is a first tether, the separating the arms includes:

applying tension to the first tether routed through at least one of a plurality of holes of the first arm; and

applying tension to a second tether routed through at least one of the plurality of holes of the second arm.

69. A method of reducing heart valve regurgitation, comprising:

inserting a steerable guide catheter having an implant catheter slidably and rotatably disposed therein through a vasculature of a patient such that a distal end of the steerable guide catheter is disposed in an atrium of the heart, the steerable guide catheter further including a steerable delivery catheter slidably and rotatably disposed therein, the implant catheter being slidably and rotatably disposed in an inner volume of the steerable delivery catheter;

with the guide catheter disposed in the atrium, advancing the implant catheter relative to the guide catheter to expose an implant within the atrium, the implant including a first arm, a second arm, and a plurality of support members each extending from the first arm to a respective free end;

applying tension to a first tether that is removably coupled to the first arm;

after applying tension to the first tether, applying tension to a second tether that is removably coupled to the second arm;

positioning the first arm on a first side of a native leaflet of the heart valve and the second arm on a second, opposite side of the native leaflet of the heart valve; and

releasing at least one of the first and second arms to couple the implant to one or more of a native leaflet or chordae tendineae of the heart valve.

70. The method of claim 69 , wherein the first tether forms a first tether loop at a first end thereof that is removably coupleable to the first arm, and the second tether forms a second tether loop at a first end thereof that is removably coupleable to the second arm.

71. The method of claim 70 , further comprising:

releasing the first tether loop and pulling a second end of the first tether proximally until the first end of the first tether is decoupled from the first arm of the implant; and

releasing the second tether loop and pulling a second end of the second tether proximally until the first end of the second tether is decoupled from the second arm of the implant.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 25, 2024
From: PADALA, SAI MURALIDHAR
To: EMORY UNIVERSITY
Reel/Frame 068079/0499 →
Continuity (2)
Provisional Application 63578923 · Aug 25, 2023
Related Publication 20250064589A1 · Feb 27, 2025
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