Devices, systems, and methods for prosthesis delivery and implantation, including the use of a fastener tool

• US 9,320,591 B2
• Filed: 03/31/2014
• Issued: 04/26/2016
• Est. Priority Date: 11/28/2001
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Bolduc, Lee
• Primary Examiner(s): Hong, John C
• Application Number:
  US14/230,469
• Publication Number:
  US 20140214051A1
• Time in Patent Office: 757 Days
• US Class Current: 1/1
• 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 17/0401 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 17/068 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 17/105 Wound clamp magazines for packaging sharps A61B50/3001
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/0688 Packages or dispensers for surgical staplers
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/9511 : the retaining means being filaments or wires
• CPC Class Codes: A61M 25/0136 : Handles therefor
• CPC Class Codes: Y10T 29/49947 : by applying separate fastener
• CPC Class Codes: Y10T 29/53487 : Assembling means comprising hand-manipulatable implement
• CPC Class Codes: Y10T 29/53491 : One work part comprising living tissue

Abstract

Devices, systems, and methods for implanting radially expandable prostheses in the body lumens rely on tacking or anchoring the prostheses with separately introduced fasteners. The prostheses may be self-expanding or balloon expandable, and may include a single lumen or more than one lumen. After initial placement, a fastener applier system is introduced within the expanded prostheses to deploy a plurality of fasteners to at least one prosthesis end. The fasteners are usually helical fasteners which are releasably restrained on the fastener driver, and are delivered by rotation of the fastener driver. The fasteners may be applied singly, typically in circumferentially spaced-apart patterns about the interior of at least one end of the prosthesis. A lumen extension or lumens may be coupled to the prosthesis to extend the reach of the prosthesis within the implantation site. Fasteners may also be applied to the lumen extensions.

Claims

1. A fastener applier for securing a prosthesis, the fastener applier comprising:

a handle assembly positioned at the caudal end of the fastener applier;

a fastener applier shaft coupled to the handle assembly, the fastener applier shaft comprising a cephalad end;

a fastener driver for advancing a helical fastener into the prosthesis and tissue, the fastener driver coupled to the fastener applier shaft at the cephalad end of the fastener applier shaft and comprising a housing, the fastener driver housing comprising an internally threaded portion and an unthreaded portion, the unthreaded portion providing an area where the helical fastener can be rotated but not advanced off of the fastener driver, the advancement off of the fastener driver only taking place if the fastener has been previously engaged in tissue or the prosthesis, wherein the handle assembly comprises a motion control assembly that controls motion of the fastener within the fastener driver, wherein the motion control assembly comprises a forward control function and a reverse control function.

2. The fastener applier of claim 1, wherein the internally threaded portion is configured to threadably receive at least a portion of the helical fastener.

3. The fastener applier of claim 1, wherein the helical fastener includes a fastener body having a distal end configured to penetrate tissue in response to a force and a proximal end configured to releasably couple the fastener body to the fastener applier.

4. The fastener applier of claim 3, wherein the proximal end of the fastener body comprises a stop structure to prevent over-penetration of the fastener body into tissue, the stop structure bisecting the diameter of the fastener body.

5. The fastener applier of claim 4, wherein the stop structure is offset from the diameter of the fastener body.

6. A fastener applier for securing a prosthesis, the fastener applier comprising:

a handle assembly positioned at the caudal end of the fastener applier;

a fastener applier shaft coupled to the handle assembly, the fastener applier shaft comprising a cephalad end;

a fastener driver for advancing a helical fastener into the prosthesis and tissue, the fastener driver coupled to the fastener applier shaft at the cephalad end of the fastener applier shaft and comprising a housing, the fastener driver housing comprising an internally threaded portion and an unthreaded portion, the unthreaded portion providing an area where the helical fastener can be rotated but not advanced off of the fastener driver, the advancement off of the fastener driver only taking place if the fastener has been previously engaged in tissue or the prosthesis, wherein the handle assembly comprises an indication assembly that provides at least one of an audible and a visual indication.

7. The fastener applier of claim 6, wherein the at least one of an audible and a visual indication indicates at least one of a fastener position, timing, status, or error.

8. A fastener applier for securing a prosthesis, the fastener applier comprising:

a fastener applier shaft comprising a cephalad end;

a fastener driver for advancing a helical fastener into the prosthesis and tissue, the fastener driver coupled to the fastener applier shaft at the cephalad end of the fastener applier shaft and comprising a housing, the fastener driver housing comprising an internally threaded portion and an unthreaded portion, the unthreaded portion arranged at and defining the cephalad end of the fastener applier, wherein the unthreaded portion provides an area where the helical fastener can be rotated but not advanced off of the fastener driver, the advancement off of the fastener driver only taking place if the fastener has been previously engaged in tissue or the prosthesis, further comprising a handle assembly positioned at the caudal end of the fastener applier, wherein the handle assembly comprises a motion control assembly that controls motion of the fastener within the fastener driver, wherein the motion control assembly comprises a forward control function and a reverse control function.

9. The fastener applier of claim 8, wherein the internally threaded portion is configured to threadably receive at least a portion of the helical fastener.

10. A fastener applier for securing a prosthesis, the fastener applier comprising:

a fastener applier shaft comprising a cephalad end;

a fastener driver for advancing a helical fastener into the prosthesis and tissue, the fastener driver coupled to the fastener applier shaft at the cephalad end of the fastener applier shaft and comprising a housing, the fastener driver housing comprising an internally threaded portion and an unthreaded portion, the unthreaded portion arranged at and defining the cephalad end of the fastener applier, wherein the unthreaded portion provides an area where the helical fastener can be rotated but not advanced off of the fastener driver, the advancement off of the fastener driver only taking place if the fastener has been previously engaged in tissue or the prosthesis, further comprising a handle assembly positioned at the caudal end of the fastener applier, wherein the handle assembly comprises an indication assembly that provides at least one of an audible and a visual indication.

11. The fastener applier of claim 10, wherein the at least one of an audible and a visual indication indicates at least one of a fastener position, timing, status, or error.

12. A system comprising:

a helical fastener; and

a fastener applier for securing a prosthesis with the helical fastener, the fastener applier comprising;

a fastener applier shaft comprising a cephalad end;

a fastener driver for advancing the helical fastener into the prosthesis and tissue, the fastener driver coupled to the fastener applier shaft at the cephalad end of the fastener applier shaft and comprising a housing, the fastener driver housing comprising an internally threaded portion and an unthreaded portion, the unthreaded portion arranged at and defining the cephalad end of the fastener applier, wherein the unthreaded portion provides an area where the helical fastener can be rotated but not advanced off of the fastener driver, the advancement off of the fastener driver only taking place if the fastener has been previously engaged in tissue or the prosthesis, further comprising a handle assembly positioned at the caudal end of the fastener applier, wherein the handle assembly comprises a motion control assembly that controls motion of the fastener within the fastener driver, wherein the motion control assembly comprises a forward control function and a reverse control function.

13. The system of claim 12, wherein the internally threaded portion threadably receives at least a portion of the helical fastener.

14. The system of claim 12, wherein the helical fastener includes a fastener body having a distal end configured to penetrate tissue in response to a force and a proximal end configured to releasably couple the fastener body to the fastener applier.

15. The system of claim 14, wherein the proximal end of the fastener body comprises a stop structure to prevent over-penetration of the fastener body into tissue, the stop structure bisecting the diameter of the fastener body.

16. The system of claim 15, wherein the stop structure is offset from the diameter of the fastener body.

17. A fastener applier for securing a prosthesis, the fastener applier comprising:

a handle assembly positioned at the caudal end of the fastener applier;

a fastener applier shaft coupled to the handle assembly, the fastener applier shaft comprising a cephalad end;

a fastener driver for advancing a helical fastener into the prosthesis and tissue, the fastener driver coupled to the fastener applier shaft at the cephalad end of the fastener applier shaft and comprising a housing, the fastener driver housing comprising an internally threaded portion and an unthreaded portion, the unthreaded portion providing an area where the helical fastener can be rotated but not advanced off of the fastener driver, the advancement off of the fastener driver only taking place if the fastener has been previously engaged in tissue or the prosthesis, where the fastener driver further comprises a fastener carrier within the fastener driver housing, the fastener driver housing being coupled to the fastener carrier.

18. The fastener applier of claim 17, wherein the fastener driver housing comprises tabs coupling the fastener driver housing to the fastener carrier.

19. The fastener applier of claim 17, wherein the fastener driver housing is snap fit to the fastener carrier.