Inflatable minimally invasive system for delivering and securing an annular implant

• US 9,326,859 B2
• Filed: 09/14/2012
• Issued: 05/03/2016
• Est. Priority Date: 02/09/2009
• Status: Expired due to Fees

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Cartledge, Richard G., Cartledge, John P., Badia, James, McCrea, James, Baez, Luis, Bentley, Peter
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): Scherbel, Tood J
• Application Number:
  US13/618,099
• Publication Number:
  US 20130123910A1
• Time in Patent Office: 1,327 Days
• US Class Current: 1/1
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/0031 for constricting the lumen; Support slings for the urethra
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2002/30537 adjustable
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon

Abstract

A delivery device for an annular implant that includes a balloon expansion mechanism and an annular implant having an adjustable dimension. The balloon expansion mechanism includes an inflation tube attached to a non-occluding balloon collar which is supported by trusses radially extending from a trocar. The annular implant further includes a flexible ring core, contiguous coiled spacers, and anchoring blocks. The flexible ring core is adjusted via a cinching mechanism. The anchoring blocks are spaced along the ring core by the contiguous coiled spacers, which keeps the distance between each pair of anchoring blocks equidistant as the ring core diameter is manipulated by the device user. The annular implant can also include gunbarrel elements housed in the trocar. Each gunbarrel element contains a gunbarrel pusher which drives an attachment element into the annular implant and annular tissue.

Claims

1. A delivery device for an annular implant comprising:

a balloon expansion mechanism, wherein the balloon expansion mechanism comprises a hollow catheter attached to an inflation tube, a non-occluding balloon collar having a distal end and a proximal end attached to and surrounding the catheter forming an annulus therebetween, the balloon collar being attached to the catheter by a plurality of wheel shaped trusses radially extending from the catheter to the balloon collar within the annulus, the plurality of wheel shaped trusses in a longitudinally spaced apart relationship relative to each other between the distal end and proximal end of the balloon collar, whereby a gas or liquid which is fed through the inflation tube provides for expansion of the balloon collar;

an annular implant having an adjustable dimension removably mounted around the non-occluding balloon collar, a ring core extending through the annular implant, wherein the balloon expansion mechanism and the annular implant are configured whereby a dimension of the annular implant is adjustably expanded by inflation of the balloon collar and is adjustably reduced by manipulation of at least one elongated cinching cord coupled to a portion of the ring core; and

a cinching mechanism attached to the annular implant receiving therein the at least one elongated cinching cord, the cinching mechanism including a securing element moveable relative to the at least one elongated cinching cord, wherein the cinching mechanism maintains the dimension of the annular implant by the securing element directly engaging the at least one elongated cinching cord within the cinching mechanism.

2. The delivery device of claim 1, wherein the ring core is flexible and wherein the flexible ring core is adjustable through two cinching cords.

3. The delivery device of claim 1, wherein the cinching mechanism comprises:

a trap element inside a hollow cylindrical housing; and

a pushrod adjacent to the trap element, wherein said pushrod engages the trap element to control movement of the at least one cinching cord, thereby controlling the adjustment of the dimension of the annular implant.

4. The delivery device of claim 1, wherein the cinching mechanism comprises a ratchet mechanism.

5. The delivery device of claim 4, wherein the ratchet mechanism includes a spool about which the at least one cinching cord is wrapped.

6. The delivery device of claim 1, wherein the cinching mechanism comprises a wedge-pin mechanism.

7. The delivery device of claim 1, wherein the cinching mechanism comprises a cam structure.

8. The delivery device of claim 1, wherein the annular implant has an upper compartment housing said ring core and a lower compartment containing a series of retention barbs either integrally formed with or fixedly attached to the annular implant, wherein selected retention barbs further contain a terminal hook for anchoring of the annular implant into annular tissue.

9. The delivery device of claim 8, further including a movable retainer guide in communication with the lower compartment of the annular implant for controlling extension of the series of retention barbs.

10. The delivery device of claim 8, wherein said lower compartment contains a retention barb housing which prevents the retention barbs from engaging the annular tissue prior to deployment.

11. The delivery device of claim 8 wherein an exterior of the annular implant is fabricated of a biologically compatible material including Dacron, PTFE, malleable metals, biologically compatible materials, or a combination of such biologically compatible materials in a molded, woven, or non-woven configuration.

12. The delivery device of claim 1, further including a check valve incorporated into the balloon expansion mechanism.

13. The delivery device of claim 1, wherein the balloon collar is either cylindrical or spherical in shape.

14. The delivery device of claim 1, wherein the annular implant comprises an adjustable annuloplasty ring.

15. The delivery device of claim 1, wherein the securing element comprises a spool assembly, the at least one cinching cord being wrapped about the spool assembly whereby rotation of the spool tightens the ring cord for maintaining a dimension of the annular implant.

16. A delivery device for an annular implant comprising:

a balloon expansion mechanism comprising a non-occluding balloon collar attached to a hollow catheter receiving a gas or liquid from an inflation tube for expansion of the balloon collar upon supplying the gas or liquid thereto, the balloon collar having a distal end and a proximal end surrounding the catheter forming an annulus therebetween, the balloon collar being attached to the catheter by a plurality of wheel shaped trusses radially extending from the catheter to the balloon collar within the annulus, the plurality of wheel shaped trusses in a longitudinally spaced apart relationship relative to each other between the distal end and proximal end of the balloon collar, whereby the gas or liquid which is fed through the inflation tube provides for expansion of the balloon collar;

an annular implant having an adjustable dimension and configured to be removably mounted about the balloon collar, the annular implant including a ring core extending therethrough coupled to at least one cinching cord, wherein the balloon expansion mechanism and the annular implant are configured whereby a dimension of the annular implant is adjustably expanded by inflation of the balloon collar and is adjustably reduced by manipulation of the at least one cinching cord; and

a cinching mechanism including a spool assembly coupled to the at least one cinching cord, whereby rotation of the spool assembly tightens the ring core for adjusting and maintaining a dimension of the annular implant.

17. The delivery device of claim 16, wherein the annular implant comprises an adjustable annuloplasty ring.

18. The delivery dimension of claim 16, wherein the ring core is flexible, and wherein the ring core is adjustable through two cinching cords wrapped about the spool assembly.

19. The delivery device of claim 16, wherein the cinching mechanism comprises a ratchet mechanism.