Minimally Invasive System for Delivering and Securing an Annular Implant

• US 20080306586A1
• Filed: 02/05/2008
• Published: 12/11/2008
• Est. Priority Date: 02/05/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Cartledge, Richard G., Cartledge, John P.
• Granted Patent: US 9,427,215 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• 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: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• 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 is provided, comprising an annular implant having an adjustable dimension; a plurality of movable elongated deployment members, each having a proximal end and a distal end and an annular implant deployment region therebetween; and a distal joining member for joining the distal ends of the deployment members, wherein the deployment members are expandable by an expansion means to a deployment configuration, and the implant deployment regions of the deployment members are substantially parallel in an expanded configuration. The annular implant can comprise an adjustment mechanism in communication with a releasably attached elongated adjustment tool, whereby the size or shape of the annular implant can be incrementally adjusted.

Claims

1. A delivery device for an annular implant comprising:

an annular implant having an adjustable dimension, wherein the annular implant comprises an adjustment mechanism and wherein the device further comprises an elongated adjustment tool having a proximal end and a distal end releasably attached to the adjustment mechanism, whereby the annular implant size or shape is incrementally adjusted;

a plurality of movable elongated deployment members, each having a proximal end and a distal end and an annular implant deployment region therebetween releasably disposable within the annulus of implant; and

a distal joining member for joining the distal ends of the deployment members;

wherein the deployment members are retractably expandable by an expansion means to an expanded configuration and wherein the implant deployment regions of the deployment members are substantially parallel in an expanded configuration.

2. The delivery device of claim 1, further comprising an elongated central support member having a proximal end and a distal end and being substantially parallel to the implant deployment regions of the deployment members, wherein the distal joining member is attached to a distal portion of the central support member.

3. The delivery device of claim 2, wherein the expansion means is a plurality of biasing members extending between the central support member and a plurality of respective deployment members, wherein each biasing member exerts an expanding force on the corresponding deployment member.

4. The delivery device of claim 3, further wherein expansion of the deployment members is limited by the size or shape of the annular implant.

5. The delivery device of claim 2, further comprising a proximal joining member for joining the proximal ends of the deployment members, wherein the proximal joining member is slidably attached along the central support member.

6. The delivery device of claim 5, wherein the expansion means is a deployment articulation member in communication with the proximal joining member, wherein the proximal joining member is movable distally to expand the deployment members and proximally to contract the deployment members.

7. The delivery device of claim 1, wherein expansion of the deployment members causes the annulus to conform to the size and shape of the annular implant.

8. The delivery device of claim 1, further comprising a control interface, wherein the control interface allows the annular implant to be advanced and oriented independent of the deployment members.

9. The delivery device of claim 1, wherein the adjustment tool is re-attachable to the adjustment mechanism after release.

10. The delivery device of claim 1, wherein at least a portion of the deployment members comprise a radio-opaque or echo-opaque material.

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

at least one elongated barrel, each barrel having a proximal end and a distal end and being movably affixed adjacent each distal end to the deployment region of a deployment member;

an attachment element within a distal portion of each barrel for attaching the annular implant to annular tissue, wherein the attachment element is made of a shape memory alloy and is fittingly situated within the barrel to guide the attachment element in a predetermined orientation with respect to the barrel; and

a corresponding elongated attachment element release member extending through the proximal end of the barrel to communicate with the attachment element;

wherein the attachment element is delivered through the distal end of the barrel into the annular implant and annular tissue by manipulating the attachment element release member.

12. The device of claim 11, wherein the attachment element is made of nitinol.

13. The device of claim 11, wherein the attachment element comprises a radio-opaque or echo-opaque material.

14. The device of claim 11, wherein the barrel has an internal surface configured to guide the attachment element in a predetermined orientation.

15. The device of claim 11, wherein the barrel has an elongated cut-out designed to allow a proximal portion of the attachment element to exit the barrel before the proximal end of the attachment element reaches the distal end of the barrel.

16. The delivery device of claim 11, further comprising an anchoring element extending from at least one barrel, wherein the anchoring element engages the annular implant, releasably attaching the annular implant to the barrel.

17. The delivery device of claim 11, further comprising an anchoring element extending from at least one barrel, wherein the anchoring element wraps around the annular implant, releasably attaching the annular implant to the corresponding barrel.

18. The delivery device of claim 17, wherein at least a portion of the barrel comprises a plurality of slots, further wherein at least one slot contains an attachment element and at least one separate slot contains an anchoring element.

19. The delivery device of claims 16, wherein the anchoring element releases from the annular implant when the annular implant is secured to annular tissue and force is applied to the barrel in a proximal direction.

20. The delivery device of claim 11, wherein the distal end of each barrel is secured to the annular implant in an orientation such that the distal end of each barrel is facing the annular implant when the deployment members are in an expanded configuration.

21. The delivery device of claim 11, wherein at least one point on each deployment member is slidably attached to a corresponding barrel.

29. A method for delivering and securing an annular implant comprising:

inserting the delivery device of claim 1 into a patient'"'"'s body;

delivering the annular implant to the desired annulus of implant;

adjusting the size or shape of the deployment members from a first size or shape to a second size or shape to match the annulus to the size and shape of the annular implant;

securing the implant to annular tissue; and

releasing the implant from the delivery device and withdrawing the delivery device from the patient'"'"'s body.

30. A method of delivering and securing an annular implant to an annulus comprising:

inserting the delivery device of claim 11 into a patient'"'"'s body;

delivering the annular implant to the desired annulus of implant;

manipulating the attachment element release members to deploy the attachment elements into the annular implant and annular tissue to secure the annular implant to the annulus; and

releasing the implant from the delivery device and withdrawing the delivery device from the patient'"'"'s body.

22. A device for delivering and attaching an annular implant that delivers the annular implant to a desired annulus of implant and attaches the annular implant to the annulus by deploying at least one memory shape attachment element into the annular implant and annulus.

23. The device of claim 22, wherein the deployment members conform the annulus to match the size and shape of the annular implant prior to attaching the annular implant to the annulus.

24. A device for delivering an annular implant, comprising:

an annular implant having an adjustable dimension, wherein the annular implant comprises an adjustment mechanism and wherein the device further comprises an elongated adjustment tool having a proximal end and a distal end releasably attached to the adjustment mechanism, whereby the annular implant size or shape is incrementally adjusted;

a spreading mechanism releasably disposable within the annular implant;

wherein the spreading mechanism is expandable to conform to the size and shape of the annular implant, and further wherein delivery of the annular implant on the spreading mechanism reshapes the annulus to conform to the size and shape of the implant.

25. A device for delivering and attaching an annular implant, comprising:

an annular implant having an adjustable dimension;

a spreading mechanism releasably disposable within the annular implant;

a plurality of barrels, each having a proximal end and a distal end; and

a control interface;

wherein the proximal end of each barrel is attached to a corresponding location on the control interface and the distal end of each barrel is releasably attached to the annular implant, and further wherein the control interface allows the annular implant to be advanced with the barrels and oriented independent of the spreading mechanism.

26. The device of claim 25, further wherein the control interface comprises a controller for adjusting the size or shape of the annular implant.

27. The device of claim 26, further wherein the control interface comprises a display which shows a measurement corresponding to the size or shape of the annular implant.

28. The device of claim 25, wherein the spreading mechanism exerts an expanding force on the annular implant, and further wherein the extent of expansion of the spreading mechanism is limited by the size or shape of the annular implant.

31. A method of delivering an annular implant to an annulus comprising:

inserting the device of claim 25 into a patient'"'"'s body;

advancing the annular implant and barrels into the patient'"'"'s left atrium using the control interface;

orienting the annular implant as desired using the control interface;

advancing the spreading mechanism through the implant using the control interface;

advancing the spreading mechanism and implant to the desired annulus of implant using the control interface.