ENCIRCLING IMPLANT DELIVERY SYSTEMS AND METHODS

• US 20160120647A1
• Filed: 06/03/2014
• Published: 05/05/2016
• Est. Priority Date: 06/12/2013
• Status: Active Grant

• Current Assignee: United States Department Of Health And Human Services
• Original Assignee: United States Department Of Health And Human Services
• Inventors: Rogers, Toby, Lederman, Robert J., Kocaturk, Ozgur, Sonmez, Merdim, Franson, Dominique N.
• Granted Patent: US 10,463,495 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00358 Snares for grasping
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2002/2484 Delivery devices therefor
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

Delivery devices for delivering encircling implants can include two separate limbs that are held together at a distal articulation by the implant being delivered. The implant can comprise a suture and/or a braided tube. The implant can extend through or over the limbs. The implant and at least a distal portion of the limbs can be compressible into a delivery shape that allows for advancement through the lumen of a delivery catheter. When the distal portion of the limbs move out of the delivery catheter, the limbs and implant can resiliently assume a loop shape that is complementary to a shape of a target around which the encircling implant is to be placed. The limbs are then retracted from along the implant to leave the implant in the desired delivery position. The delivery device can be used to place encircling implants around the heart or other targets, and the implant can be tightened to exert compressive force on the target.

Claims

1. A device for delivering through a catheter an encircling implant around a portion of a target structure in a body, the device comprising:

first and second delivery limbs linked at an articulation region between distal ends of the first and second limbs by a continuous flexible encircling implant that is to be delivered and which extends through or over the first and second limbs to maintain the distal ends of the first and second limbs together in an articulating relationship at a distal articulation tip,

wherein at least a distal limb portion of each limb is resiliently deformable into the delivery shape but when not deformed into the delivery shape is configured to cooperatively form with the contralateral limb a loop that can be placed circumferentially around the portion of the target structure in order to locate the encircling implant around the portion of the target structure.

2. The device of claim 1, wherein the encircling implant is tubular and the first and second delivery limbs extend within a lumen of the tubular implant during delivery.

3. The device of claim 1, wherein the encircling implant is a suture, wire, cable, or cord that extends through the first and second delivery limbs during delivery.

4. The device of claim 1, wherein the distal limb portions are cooperatively biased to assume a loop shape and sized substantially complementary to the portion of the target structure around which the loop is to be circumferentially placed.

5. The device of claim 1, wherein the target structure comprises a base portion connected to the body and a free portion over and around which the loop can be passed.

6. The device of claim 1, wherein the target structure comprises a heart or atrial appendage, a cecal appendix, a gallbladder, a neoplasm, a uterus, a hemorrhoid, an uvula, an aneurysm, a transected blood vessel or other transected, folded or looped lumen, an intraocular crystalline lens or implanted intraocular lens or lens haptic, a urinary bladder, a kidney, a prostate or a foreign body.

7. The device of claim 1, wherein the first and second delivery limbs extend alongside a looped portion of a suture within a lumen of the encircling implant during delivery of the encircling implant around the target structure, and with the first and second delivery limbs retracted from the lumen of the encircling implant the looped portion of the suture can be reduced in circumference to tighten the encircling implant around the target structure.

8. The device of claim 1, wherein the first and second limbs are separate and proximal limb portions of the first and second delivery limbs are substantially parallel to one another in the delivery shape, and the distal limb portions are substantially parallel to one another in the delivery shape.

9. The device of claim 8, wherein the proximal and distal limb portions are constrainable into the delivery shape by a lumen within a flexible delivery catheter though which the encircling implant is to be delivered to the target structure in the body, wherein the delivery catheter comprises a distal end for initial introduction into the body and a proximal end for controlling the delivery catheter.

10. The device of claim 9, wherein the proximal limb portions are flexible to conform to the shape of the lumen within the flexible delivery catheter with the proximal limb portions parallel to one another, and the proximal limb portions are sufficiently rigid to maintain a substantially parallel relationship when only a distal portion of the proximal limb portions extends from the lumen, and the proximal limb portions are connected together in at least one location to rotationally constrain the proximal limb portions with respect to each other.

11. The device of claim 10, further comprising the delivery catheter, wherein the suture comprises first and second terminal ends, and the suture extends continuously through the delivery limbs within the percutaneous delivery device with the first and second terminal ends of the suture extending from the proximal tip of the delivery catheter or an intermediate opening along each of the first and second delivery limbs.

13. The device of claim 1, wherein the first and second delivery limbs are capable of being withdrawn from the encircling implant and from the body once the encircling implant is delivered around the target structure.

15. The device of claim 1, wherein the loop is substantially circular or cordiform and each distal limb portion forms a substantially semi-lunar or semi-cordiform shape joined at the articulation tip.

16. The device of claim 1, wherein the loop extends at a predetermined angle with respect to a longitudinal axis of the catheter.

17. The device of claim 1, wherein the loop folds back toward the proximal limb portion.

18. The device of claim 1, wherein the flexible distal limb portions of the first and second delivery limbs cooperatively form geometric shapes, such as asymmetric nested semilunar arcs, that are substantially co-planar or not-coplanar when the flexible distal limb portions form the loop.

19. The device of claim 1, wherein the delivery limbs are removable from their positions around or within the continuous encircling implant to leave the encircling implant in place around the target structure after the delivery limbs are removed from the encircling implant, and the encircling implant can be tightened after placement around the target structure to circumferentially compress the target structure.

52. A method of using the device of claim 1 to deliver an encircling implant around a target structure in a body through an elongated delivery catheter having a lumen, a proximal control end and a distal end, the method comprising:

advancing the first and second delivery limbs through the lumen of the delivery catheter with the distal articulation tip leading and with the first and second delivery limbs substantially conforming to a shape of the lumen of the delivery catheter; and

further advancing the first and second delivery limbs until the distal limb portions emerge from the lumen at the distal end of the delivery catheter and form the loop while at least a portion of the delivery limbs or a proximal guide member attached to the delivery limbs is retained within the delivery catheter.

12. (canceled)

14. (canceled)

20. A device for delivering a continuous flexible encircling implant around a portion of a target structure in a subject'"'"'s body, the device comprising:

a flexible delivery catheter having a lumen, a proximal end for controlling the catheter and a distal delivery end for introduction into the body;

a guide comprising first and second delivery limbs maintained in an articulating relationship at a distal articulation tip by the continuous flexible encircling implant, wherein the encircling implant extends through or over the first and second delivery limbs and bridges a gap between distal ends of the first and second delivery limbs to form the articulation tip,

wherein at least distal portions of the first and second delivery limbs are resiliently deformable into a delivery shape to extend along the longitudinal axis of the delivery catheter, but resiliently assume a loop shape cooperatively formed by the two distal limb portions when not deformed into the delivery shape, and the loop shape has a size and shape substantially complementary to a feature of the target structure such that the distal limb portions cause the encircling implant to assume a loop for placement of the encircling implant around the target structure.

21. The device of claim 20, wherein at least the distal limb portions comprise a superelastic or shape-memory material.

22. The device of claim 20, wherein the distal limb portions in the delivery shape deflect toward the delivery catheter as the distal limb portions emerge from the distal delivery end of the delivery catheter.

23. The device of claim 20, wherein the encircling implant comprises a tubular implant and the distal limb portions extend through a lumen of the tubular implant.

24. The device of claim 20, wherein the encircling implant is non-tubular and extends through lumens in the first and second delivery limbs.

25. The device of claim 20, wherein an orientation of the loop with respect to the delivery catheter is controllable by moving one or both of the first and second delivery limbs.

26. The device of claim 20, wherein the distal limb portions are configured to assume a shape and size substantially complementary to a circumference of the target structure around which the loop is to be circumferentially navigated or placed, and the target structure comprises a body organ, neoplasm, or surgically implanted device.

28. The device of claim 20, wherein the target structure comprises a heart, and the distal limb portions are configured to deflect the loop toward the delivery catheter and around the apex of the heart.

27. (canceled)

29. A method of delivering an encircling implant for placement around a target structure in a body the method comprising:

advancing delivery limbs of a delivery guide through an elongated delivery catheter, the delivery catheter comprising a lumen, a proximal control end, and a distal end, with an articulated tip of the delivery guide being advanced through the delivery catheter ahead of the delivery limbs, and with the delivery limbs substantially conforming to the shape of the lumen of the delivery catheter;

wherein the delivery limbs are maintained in an articulating relationship at the articulation tip by a continuous flexible encircling implant, wherein the encircling implant extends through or over the delivery limbs and bridges a gap between adjacent ends of the delivery limbs to form the articulation tip; and

further advancing the delivery limbs relative to the delivery catheter until the distal limb portions of the delivery limbs emerge from the lumen at the distal end of the delivery catheter and resiliently assume a loop shape causing the encircling implant to form a loop, while at least a portion of the delivery limbs or a proximal guide member attached to the delivery limbs is retained within the delivery catheter.

30. The method of claim 29, further comprising placing the loop around the target structure to encircle the target structure.

31. The method of claim 30, further comprising individually or cooperatively moving the first and second delivery limbs to adjust an orientation of the loop with respect to the delivery catheter and the target structure.

32. The method of claim 30, further comprising withdrawing the delivery limbs from the encircling implant into the delivery catheter to leave the encircling implant positioned and secured around the target structure, wherein tension is applied to the encircling implant while the delivery limbs are withdrawn to maintain the encircling implant in a desired position until two free ends of the encircling implant are subsequently secured together.

33. The method of claim 32, further comprising tightening the encircling implant around the target structure.

34. The method of claim 32, further comprising withdrawing the delivery catheter from the body.

35. The method of claim 29, further comprising inserting the distal end of the delivery catheter percutaneously, through an introducer sheath into the body and advancing the distal end of the delivery catheter to the target structure within the body, wherein the delivery catheter is advanced intravascularly through the inferior vena cava until the distal end of the delivery catheter penetrates a wall of the heart, then advancing the delivery limbs out of the distal end of the delivery catheter until the distal delivery limbs form the looped shape.

37. The method of claim 35, wherein the loop forms a shape substantially conforming to a circumference of the heart, and the loop assumes a pre-configured angle with respect to the proximal portions of the delivery limbs, and the loop is advanced around the apex of the heart until the loop encircles the heart, then the delivery limbs are withdrawn proximally into the delivery catheter to leave the encircling implant which encircles the heart, and the encircling implant is tightened by exerting tension on terminal ends of the encircling implant or by tightening a suture passing through the implant, to improve a function of a heart valve within the heart.

38. The method of claim 37, wherein

(a) the distal end of the delivery catheter penetrates the heart through an atrial appendage, and the loop substantially conforms to a circumference of a targeted atrial appendage of the heart, and the loop is advanced around the atrial appendage until the loop encircles the targeted atrial appendage, then the delivery limbs are withdrawn proximally into the delivery catheter to expose the encircling implant which encircles the targeted atrial appendage and the encircling implant is tightened by exerting tension on the terminal ends of the encircling implant to exclude the targeted atrial appendage;

or

(b) the distal end of the delivery catheter approaches the heart by a trans-thoracic or sub-xiphoid path and the loop is advanced around the atrial appendage until the loop encircles the atrial appendage, then the delivery limbs are withdrawn proximally into the delivery catheter to expose the encircling implant which encircles the atrial appendage and the encircling implant is tightened by exerting tension on terminal ends of the encircling implant to tighten the encircling implant and exclude the atrial appendage.

45. The method of claim 29, wherein a protection device or a compression device is advanced over the encircling implant into a desired position with respect to the target structure, or a compression device is included as part of the encircling implant during delivery of the encircling implant.

46. The method of claim 45, wherein the target structure is the heart, and the compression device is advanced over the encircling implant to a position on an external wall of the myocardium to exert pressure on the external wall and change a shape and function of a valve of the heart.

47. The method of claim 46, wherein the valve is the mitral or tricuspid valve.

48. The method of claim 45, wherein the target structure is the heart, and a protection device is advanced over or within the encircling implant to a position on an external wall of the myocardium to bridge a coronary artery and avoid compression of the coronary artery when the encircling implant is tightened around the heart.

49. The method of claim 29, wherein the target structure is the right ventricular outflow tract or main pulmonary artery.

36. (canceled)

39. The method of claim 36 wherein the distal end of the delivery catheter is inserted intraluminally into a body lumen and advanced to the target structure.

41. The method of claim 36 wherein the distal end of the delivery catheter is inserted percutaneously into the body and advanced to the target structure.

42. The method of claim 41, wherein the distal end of the delivery catheter is inserted percutaneously into a body cavity.

44. The method of claim 39 wherein the target structure is a foreign body that is to be repositioned within or retrieved from the body.

40. (canceled)

43. (canceled)

50-51. -51. (canceled)