Method and apparatus for implanting a graft in a vessel of a patient

• US 5,968,053 A
• Filed: 01/31/1997
• Issued: 10/19/1999
• Est. Priority Date: 01/31/1997
• Status: Expired due to Fees

• Current Assignee: Cardiacassist Inc. (LivaNova Plc)
• Original Assignee: Cardiac Assist Technologies Incorporated
• Inventors: Revelas, Demetrios
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US08/792,562
• Time in Patent Office: 991 Days
• Field of Search: 606/1, 606/108, 606/151, 606/191-200, 604/96-104, 623/1, 623/11, 623/12
• US Class Current: 606/108
• 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 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 2017/00867 shape memory effect for prostheses A61F2210/0014
• 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 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts

Abstract

The present invention pertains to an apparatus for implanting a graft into a vessel of a patient. The apparatus includes a mechanical delivery mechanism for delivering the graft to a desired location inside the vessel and then withdrawing from the vessel. The apparatus also has an anchoring mechanism for anchoring the graft to the interior surface of the vessel from the inside of the vessel. The anchoring mechanism is connected to the delivery mechanism. The present invention pertains to a method of implanting a graft in a vessel of a patient. The method includes the steps of delivering a graft to a desired location inside the vessel with a delivery mechanism. Next, there is the step of piercing the vessel from the interior of the vessel with anchors connected to the graft from inside the vessel. Then, there is the step of anchoring the anchors in the vessel to hold the graft in the vessel by changing the shape of the anchors.

Claims

1. An apparatus for implanting a graft into a vessel of a patient comprising:

a mechanical delivery mechanism for delivering the graft to a desired location inside the vessel and then withdrawing from the vessel, said delivery mechanism includes an expansion mechanism comprising a portion and a hinge about which the portion of the expansion mechanism rotates; and

an anchoring mechanism for anchoring the graft to the interior surface of the vessel from the inside of the vessel, said anchoring mechanism connected to the delivery mechanism, said expansion mechanism expands inside the vessel to cause the anchoring mechanism to pierce the vessel, said anchoring mechanism is adapted to pierce through the graft and the vessel from the interior surface of the vessel and engage with the exterior surface of the vessel under the operation of the delivery mechanism.

2. An apparatus as described in claim 1 wherein the anchoring mechanism is adapted to separate from the delivery mechanism after the anchoring mechanism has engaged the exterior surface of the vessel and anchored in the vessel and the delivery mechanism is withdrawn.

3. An apparatus as described in claim 2 wherein the delivery mechanism includes a housing which is positioned about the expansion mechanism to protect the expansion mechanism while it is inside the vessel.

4. An apparatus as described in claim 3 wherein the delivery mechanism includes a first catheter mechanism connected to the housing for moving the housing relative to the expansion mechanism.

5. An apparatus is described in claim 4 wherein the delivery mechanism includes a second catheter mechanism in which the first catheter mechanism is disposed and a third catheter mechanism in which the second catheter mechanism is disposed and the first catheter mechanism extends through the expansion mechanism.

6. An apparatus as described in claim 5 wherein the expansion mechanism is connected to the second and third catheter mechanisms, said second and third catheter mechanisms each having an end which is adapted to be disposed in the vessel, and the relative movement of the second and third catheter ends to each other cause the expansion mechanism to expand or contract.

7. An apparatus as described in claim 6 wherein the anchoring mechanism includes a plurality of anchors, and wherein the expansion mechanism comprises a plurality of portions, each portion comprising a spoke set, each spoke set moveably attached to an anchor, each spoke set connected to the second and the third catheter mechanisms such that as the second catheter end moves toward the third catheter end when they are in the vessel, the spoke sets expand radially outward relative to the first catheter mechanism causing the anchors on the spoke sets to pierce the vessel.

8. An apparatus as described in claim 7 wherein at least a portion of the anchor is made of a material having a shape memory with a first memory shape being essentially of a straight pin to penetrate the vessel and a second memory shape being essentially of a hooked pin which catches with the exterior surface of the vessel.

9. An apparatus as described in claim 8 wherein the anchor includes a base which removably attaches with the spoke set and from which the material with memory shape extends.

10. An apparatus as described in claim 9 wherein each spoke set includes an upper spoke having a first upper end and a second upper end with said first upper end hingedly connected to the second catheter end, a first hinge connected to the second upper end of the upper spoke;

and a lower spoke having a first lower end and a second lower end with the first lower end hingedly connected to the third catheter end and the first hinge connected to the lower spoke adjacent the second lower end but with said second lower end extending past said first hinge, said base of said anchor engaged with said second lower end such that when the third catheter end moves toward the second catheter end, the upper and lower spokes pivot about the first hinge and close upon each other as they move radially outward from the second and third catheter mechanisms and the anchor on the second lower end of the lower spoke pierces the vessel, said upper and lower spokes retracting back into a parallel position with the second catheter mechanism as the third catheter end moves away from the second catheter end.

11. An apparatus as described in claim 6 wherein the expansion mechanism comprises a mechanical balloon connected to the second and third catheter mechanisms which extends outward from the second and third catheter mechanisms when the second and third catheter ends move toward each other and contracts inward toward the second and third catheter mechanisms when the second and third catheter ends move away from each other.

12. An apparatus as described in claim 11 wherein said anchor mechanism includes a plurality of anchors, and the mechanical balloon includes a plurality of bendable spokes connected to the second and third catheter ends and disposed alongside each other about the circumference of the second and third catheter ends, each bendable spoke having a pin holder made of memory shape material on which the anchor is engaged, said pin holder connected to the center of the bendable spoke such that when the second and third catheter ends move toward each other and the bendable spokes bend outwards from the second and third catheter mechanisms, the pin holder extends perpendicularly from the bendable spoke and the anchor on the pin holder pierces the vessel.

13. An apparatus as described in claim 6 wherein the housing includes an upper housing connected to the first catheter mechanism and a lower housing connected to the third catheter mechanism and wherein the expansion mechanism includes a plurality of spring loaded spokes each having an anchor attached to them, said spring loaded spokes each also having a spring, said spokes connected to the second catheter mechanism adjacent the second catheter end and about the circumference of the second catheter mechanism such that when the spring loaded spokes move away from the lower housing and the second and third catheter ends move away from each other, they move open and extend perpendicularly from the second catheter mechanism and force the anchors attached to them to pierce the vessel.

14. A method of implanting a graft in a vessel of a patient comprising the steps of:

delivering a graft to a desired location inside the vessel with a delivery mechanism;

expanding an expansion mechanism of the delivery mechanism about a hinge of the expansion mechanism;

piercing the vessel from the interior of the vessel with anchors connected to the graft from inside the vessel from the action of the expansion mechanism; and

anchoring the anchors in the vessel to hold the graft in the vessel by changing the shape of the anchors.

15. A method as described in claim 14 including after the anchoring step, there is the step of withdrawing the delivery mechanism from the vessel.

16. A method as described in claim 15 wherein the anchoring step includes the step of anchoring the anchor to the exterior surface of the vessel.

17. A method as described in claim 16 including after the anchoring step, there is the step of separating the anchors from the delivery mechanism.

18. A method as described in claim 17 wherein the piercing step includes the step of expanding an expansion mechanism of the delivery mechanism which is adapted to expand inside the vessel to cause the anchors to pierce the vessel.

19. A method as described in claim 18 wherein the delivery step includes the step of moving a second catheter connected to the expansion mechanism relative to a third catheter mechanism connected to the expansion mechanism to cause the expansion mechanism to expand.

20. An apparatus for implanting a graft into a vessel of a patient comprising:

a mechanical delivery mechanism for delivering the graft to a desired location inside the vessel and then withdrawing from the vessel, the delivery mechanism includes an expansion mechanism, the delivery mechanism includes a housing which is positioned about the expansion mechanism to protect the expansion mechanism while it is inside the vessel, the delivery mechanism includes a first catheter mechanism connected to the housing for moving the housing relative to the expansion mechanism, the delivery mechanism includes a second catheter mechanism in which the first catheter mechanism is disposed and a third catheter mechanism in which the second catheter mechanism is disposed and the first catheter mechanism extends through the expansion mechanism, the expansion mechanism is connected to the second and third catheter mechanisms, said second and third catheter mechanisms each having an end which is adapted to be disposed in the vessel, and the relative movement of the second and third catheter ends to each other cause the expansion mechanism to expand or contract; and

an anchoring mechanism for anchoring the graft to the interior surface of the vessel from the inside of the vessel, said anchoring mechanism connected to the delivery mechanism, said anchoring mechanism is adapted to pierce through the graft and the vessel from the interior surface of the vessel and engage with the exterior surface of the vessel under the operation of the delivery mechanism, the anchoring mechanism is adapted to separate from the delivery mechanism after the anchoring mechanism has engaged the exterior surface of the vessel and anchored in the vessel and the delivery mechanism is withdrawn, said expansion mechanism expands inside the vessel to cause the anchoring mechanism to pierce the vessel.

21. A method of implanting a graft in a vessel of a patient comprising the steps of:

delivering a graft to a desired location inside the vessel with a delivery mechanism;

piercing the vessel from the interior of the vessel with anchors connected to the graft from inside the vessel;

anchoring the anchors in the exterior surface of the vessel to hold the graft in the vessel by changing the shape of the anchors; and

withdrawing the delivery mechanism from the vessel.