Encircling implant delivery systems and methods

Patent metadata

Field	Value
Publication number	US-10463495-B2
Application number	US-201414898020-A
Country	US
Kind code	B2
Filing date	Jun 3, 2014
Priority date	Jun 12, 2013
Publication date	Nov 5, 2019
Grant date	Nov 5, 2019

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.

First claim

The invention claimed is:

1. A system for delivering through a catheter an encircling implant around a portion of a target structure in a body, the system comprising:
a flexible delivery catheter;
a continuous flexible encircling implant that is to be delivered via the delivery catheter; and
first and second delivery limbs linked at an articulation region between distal ends of the first and second limbs by the encircling implant and wherein the encircling implant extends 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 a 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;
wherein the encircling implant forms a loop that extends from adjacent the delivery catheter, along a length of the first delivery limb to the distal end of the first delivery limb, across the articulation region to the distal end of the second delivery limb, and along a length of the second delivery limb back to adjacent the delivery catheter; and
wherein the encircling implant is tubular and the first and second delivery limbs extend within a lumen of the encircling implant during delivery.

2. The system 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.

3. The system 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.

4. The system 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.

5. The system of claim 1 , wherein the first and second delivery limbs extend alongside a looped portion of a suture within the 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.

6. The system 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.

7. The system of claim 6 , wherein the proximal and distal limb portions are constrainable into the delivery shape by a lumen within the flexible delivery catheter through 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.

8. The system of claim 7 , 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.

9. The system 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.

10. The system 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.

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

12. The system of claim 1 , wherein the loop folds back toward proximal limb portions.

13. The system of claim 1 , wherein the flexible distal limb portions of the first and second delivery limbs cooperatively form geometric shapes that are substantially co-planar or not-coplanar when the flexible distal limb portions form the loop.

14. The system of claim 1 , wherein the delivery limbs are removable from their positions 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.

15. A method of using the system of claim 1 to deliver the encircling implant around the target structure in the body through the delivery catheter having 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.

16. A system for delivering a continuous flexible encircling implant around a portion of a target structure in a subject's body, the device comprising:
the continuous flexible encircling implant;
a flexible delivery catheter having a lumen, a proximal end for controlling the catheter and a distal delivery end for introduction into the body; and
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 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, wherein the encircling implant forms a loop that extends from adjacent the distal delivery end of the catheter, along a length of the first delivery limb to the distal end of the first delivery limb, across the gap to the distal end of the sec

Assignees

• Us Health

Inventors

• Rogers Toby
• Lederman Robert J
• Sonmez Merdim
• Franson Dominique N
• Kocaturk Ozgur

Classifications

• A61F2/2481 Primary

  Devices outside the heart wall, e.g. bags, strips or bands · CPC title

• A61B17/221

  Gripping devices in the form of loops or baskets {for gripping calculi or similar types of obstructions (surgical snare instruments A61B17/32056)} · CPC title

• A61B2017/00358

  Snares for grasping · CPC title

• A61B2017/00292

  mounted on or guided by flexible, e.g. catheter-like, means · CPC title

• A61B2017/2212

  having a closed distal end, e.g. a loop · CPC title