INFLATABLE MINIMALLY INVASIVE SYSTEM FOR DELIVERING AND SECURING AN ANNULAR IMPLANT

• US 20110093062A1
• Filed: 02/09/2010
• Published: 04/21/2011
• Est. Priority Date: 02/09/2009
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Inventors: Cartledge, Richard G., McCrea, James, Cartledge, John P., Bentley, Peter, Baez, Luis, Badia, James
• Granted Patent: US 8,574,289 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 lateral eyelet for attaching suture to needle A61B2017/06019
• 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 whereby a gas or liquid is fed through said inflation tube and a non-occluding balloon collar attached to the inflation tube to provide for expansion of the balloon collar, wherein the balloon collar is supported by a plurality of trusses radially extending from a trocar; and

an annular implant having an adjustable dimension removably mounted around the non-occluding balloon collar.

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

3. The delivery device of claim 1, wherein the balloon collar is any size or shape suitable for deployment in a lumen.

4. The delivery device of claim 1, wherein the balloon is made of a flexible biocompatible material.

5. The delivery device of claim 1, wherein a check valve is incorporated into the balloon expansion mechanism.

6. The delivery device of claim 1:

wherein the annular implant comprises a flexible ring core and wherein the flexible ring core is adjustable through two cinching cords;

and further comprising a cinching mechanism attached to the flexible ring core, wherein said cinching mechanism reshapes the annular implant to conform to the size and shape of the annulus via the cinching cords.

7. The delivery device of claim 1, further comprising:

a plurality of gunbarrel elements, wherein each gunbarrel element contains a hollow insert and a gunbarrel pusher and wherein the gunbarrel pusher drives an attachment element into the annular implant and annular tissue;

a plurality of anchoring blocks attached to the annular implant, wherein each gunbarrel element is anchored into a corresponding anchoring block;

a plurality of contiguous coiled spacers coiled along the annular implant, wherein each coiled spacer keeps each pair of anchoring blocks equidistant as the annular implant diameter is manipulated;

a trocar releasably housing the gunbarrel elements; and

a proximal control interface having control mechanisms for inflation of the balloon collar and deployment of the attachment elements.

8. The delivery device of claim 7, wherein the trocar houses an alignment disc, wherein the alignment disc provides separation to the gunbarrel elements during device introduction.

9. The delivery device of claim 6, 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 cinching cords, thereby controlling the adjustment of the flexible ring core.

10. The delivery device of claim 6, wherein the cinching mechanism comprises a ratchet mechanism.

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

12. The delivery device of claim 6, wherein the cinching mechanism comprises a cam structure.

13. The delivery device of claim 6, wherein the annular implant has an upper compartment housing said flexible 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 firm anchoring of the annular implant into the annular tissue;

and

a movable retainer guide in communication with the lower compartment of the annular implant controls extension of the series of retention barbs.

14. The delivery device of claim 13, wherein said lower compartment contains a retention barb housing which prevents the retention barb from engaging the valve annulus prior to deployment.

15. The delivery device of claim 13 wherein the exterior of the annular implant is fabricated of a biologically compatible material such as Dacron, PTFE, malleable metals, other biologically compatible materials, or a combination of such biologically compatible materials in a molded, woven, or non-woven configuration.

16. The delivery device of claim 7, wherein said control interface comprises:

a plurality of attachment activator buttons, wherein each attachment activator button has the capacity to drive a single attachment element and hollow insert into the annular implant and valve annulus; and

a two-button activation device wherein said two-button activation device attaches to each attachment activator button individually, which allows the device user to control delivery of the hollow insert and the attachment element into the annular implant and valve annulus.

17. A reversible attachment apparatus comprising:

an annular implant having an upper compartment housing said flexible 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 firm anchoring of the annular implant into the annular tissue; and

a movable retainer guide in communication with the lower compartment of the annular implant controls extension of the series of retention barbs.

18. The reversible attachment apparatus of claim 17, wherein said lower compartment contains a retention barb housing which prevents the retention barb from engaging the valve annulus prior to deployment.

19. The reversible attachment apparatus of claim 17, wherein the lower compartment comprises foam or a foam-like material through which the retention barbs extend to contact the annulus when deployed by the retaining guide.

20. The reversible attachment apparatus of claim 17, wherein the exterior of the annular implant is fabricated of a biologically compatible material such as Dacron, PTFE, malleable metals, other biologically compatible materials, or a combination of such biologically compatible materials in a molded, woven, or non-woven configuration.