Apparatus and methods for fastening tissue layers together with multiple tissue fasteners

• US 9,936,955 B2
• Filed: 03/05/2015
• Issued: 04/10/2018
• Est. Priority Date: 01/11/2011
• Status: Active Grant

• Current Assignee: Amsel Medical Corporation
• Original Assignee: Amsel Medical Corporation
• Inventors: Miller, Arnold, Miller, Raanan, Lilach, Nir, Edelman, William
• Primary Examiner(s): Yabut, Diane
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US14/639,814
• Publication Number:
  US 20150173765A1
• Time in Patent Office: 1,132 Days
• Field of Search: 606158
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00595 Cauterization

Abstract

A system for occluding a hollow structure, the system comprising: a plurality of occluders; and an applicator for storing the plurality of occluders and serially delivering the occluders so as to occlude the hollow structure.

Claims

1. An apparatus for deploying multiple tissue fasteners for fastening tissue layers together comprising:

a frame;

a carrier for a plurality of needle and fastener assemblies, the carrier having multiple chambers, each containing a needle and fastener assembly that comprises;

a hollow needle adapted to be passed through tissue layers to be fastened, the needle containing, in tandem, a proximal implant and a distal implant, the implants each having legs configured to radially self-expand when ejected from the needle to engage tissue layers between the implants, the implants being lockable to each other after ejection in response to engagement of the implants with each other;

the carrier being rotatably mounted to the frame about a central axis to selectively align one of the carrier chambers with a delivery axis offset from the central axis, the needle and fastener assembly aligned with the delivery axis comprising an active assembly, the other needle and fastener assemblies comprising inactive assemblies;

control members operatively associated with the implants to eject the implants from the needle sequentially and on opposite sides of the tissue layers after the needle has been passed through tissue, each of the control members being movable along the delivery axis to move the implants axially; and

a drive mechanism operatively associated with the control members for axially moving the implants in a predetermined sequence and direction after the needle has been passed through tissue, first to eject the distal implant out of the needle distally of the tissue, then to eject the proximal implant from the needle proximally of the tissue, then to move at least one of the implants relative to the other to draw the implants together to a locked position and then to release the apparatus from the implant.

2. The apparatus of claim 1 further comprising:

a control member operatively associated with the needle to axially move the needle;

the predetermined sequence and direction being preceded by advancement of the needle distally beyond the distal end of the carrier to enable the needle to be passed through tissue.

3. The apparatus of claim 2 further comprising a needle control member releasably lockable to the proximal end of the needle.

4. The apparatus of claim 1 further comprising:

the proximal and distal implants having first and second latching elements, respectively, by which the implants can be locked together;

the distal implant having a third latch element at its proximal end;

one of the control members having a fourth latch element at its distal end that is releasably engageable with the third latch element whereby the position of the distal implant can be retained when the implants are drawn together.

5. The apparatus of claim 4 further comprising an overtube adapted to removably cover the connected third and fourth latch elements.

6. The apparatus of claim 4 wherein the distal implant has a proximally extending locking rod, the third latch element being disposed on the locking rod.

7. The apparatus of claim 1 in which one of the control members comprises a proximal implant push rod engageable with the proximal end of the proximal implant to move the proximal implant in a distal direction.

8. The apparatus of claim 1 wherein the carrier is manually rotatable.

9. The apparatus of claim 1 further comprising a detent mechanism to secure the carrier to align a chamber in an active position.

10. The apparatus of claim 1 where the drive mechanism comprises:

a plurality of triggers, each operatively associated with one of the control members.

11. The apparatus of claim 1 in which the drive mechanism comprises a battery powered motor.

12. The apparatus of claim 1 wherein one of the control members comprises:

a distal implant retention shaft detachably connected at an interlock to the distal implant.

13. The apparatus of claim 12 wherein one of the control members comprises a removable locking rod extending through the interlock.

14. The apparatus of claim 12 wherein one of the control members comprises an overtube extending over the interlock.

15. The apparatus as defined in claim 1 further comprising:

each of the implants, when expanded, having a plurality of radially extending legs, the implants being configured so that when brought together in the absence of tissue, the legs of the proximal implant are interdigitated with the legs of the distal implant.

16. A delivery device for deploying multiple tissue fasteners comprising:

a frame;

a carrier for a plurality of needle and fastener assemblies, the carrier having multiple chambers, each adapted to contain a needle and fastener assembly that comprises;

(i) a hollow needle adapted to be passed through tissue layers to be fastened, the needle containing a proximal implant and a distal implant, the implants being configured to self-expand when ejected from the needle, the implants being lockable to each other after ejection in response to drawing the implants together and

(ii) control members operatively associated with the implants to eject the implants from the needle after the needle has been passed through tissue;

the carrier being rotatable about an axis to selectively align one of the carrier chambers and its contained needle and fastener assembly with a delivery axis, the aligned needle and fastener assembly comprising an active assembly, the other needle and fasteners assemblies comprising inactive assemblies;

a drive mechanism operatively positioned with respect to the delivery axis and constructed to engage the control members of an active needle and fastener assembly to move the control members in a predetermined sequence and direction in which first, the needle is exposed distally of the carrier to enable the needle to be passed through tissue layers, then, after the needle has been passed through tissue to eject the distal implant out of the needle distally of the tissue, then to eject the proximal implant from the needle proximally of the tissue, then to move at least one of the implants relative to the other to draw the implants together to a locked position and then to release the delivery device from the implant.

17. A method of delivering and deploying a plurality of tissue fasteners from a delivery device to fasten at least one tissue layer to another tissue layer or a layer of graft material comprising:

providing a carrier for a plurality of needle and fastener assemblies, the carrier having multiple chambers, each containing a needle and fastener assembly that comprises;

(i) a hollow needle adapted to be passed through tissue layers to be fastened, the needle containing, in tandem, a proximal implant and a distal implant, the implants being configured to self-expand when ejected from the needle, the implants being lockable to each other after ejection in response to drawing the implants together and

(ii) control members operatively associated with the needle and implants to eject the implants from the needle after the needle has been passed through tissue;

positioning the carrier to selectively align one of the carrier chambers and its associated needle and fastener assembly with a delivery axis, the needle and fastener assembly aligned with the delivery axis comprising the active assembly, the other assemblies comprising inactive assemblies;

moving each of the control members axially in a direction and sequence in which, after the needle has been passed through the layers, first to eject the distal implant out of the needle distally of the layers, then to eject the proximal implant from the needle proximally of the layers, then to move at least one of the implants relative to the other to draw the implants together to a locked position and then to release the delivery device from the implant;

repositioning the carrier to align another of the chambers with the delivery axis and repositioning the delivery device to another tissue location;

again, moving the control members of the repositioned carrier after the needle has been passed through tissue, first to eject the distal implant out of the needle distally of the tissue, then to eject the proximal implant from the needle proximally of the tissue, then to move at least one of the implants relative to the other to draw the implants together to a locked position and then to release the delivery device from the implant.

18. A delivery device for deploying multiple tissue fasteners comprising:

a frame;

a carrier rotatably mounted to the frame, the carrier having a plurality of chambers, each containing a fastener assembly that comprises a proximal implant and a distal implant arranged in tandem distally of the proximal implant, the implants being configured to self-expand when ejected from the lumen of a hollow delivery needle, the expanded implants being lockable to each other after ejection in response to drawing the implants together;

the hollow delivery needle mounted in a fixed position relative to the frame and having a delivery axis, the carrier being mounted for rotation to position a selected chamber in alignment with the delivery axis;

control members operatively engageable with the implants for transferring the unexpanded implants contained in the selected chamber from that chamber into the hollow needle;

the control members being operatively associated with the implants to eject the implants from the needle sequentially and on opposite sides of the tissue after the needle has been passed through tissue, each of the control members being movable along the delivery axis; and

a drive mechanism operatively associated with the control members for axially moving the implants in a predetermined sequence and direction after the needle has been passed through tissue, first to eject the distal implant out of the needle distally of the tissue, then to eject the proximal implant from the needle proximally of the tissue, then to move at least one of the implants relative to the other to draw the implants together to a locked position and then to release the delivery device from the implant.