Systems, tools, and methods for connecting to tissue
View Patent ↗Described are various embodiments of surgical procedure systems, devices, tools, and methods, useful for placing a soft tissue anchor at anatomical tissue; these may be useful for general surgical procedures, veterinary procedures, plastic surgery, and for treating pelvic conditions such as vaginal prolapse, incontinence, and other conditions caused by muscle and ligament weakness, the devices and tools being useful for accessing a posterior region of pelvic anatomy, and related methods.
1. A soft tissue anchor delivery device in combination with a soft tissue anchor,
the soft tissue anchor comprising a first elongate leg, a second elongate leg, and a tie connecting the first elongate leg to the second elongate leg, wherein the tie comprises a first tie end connected to the first leg at a medial location, and a second tie end connected to the second leg at a medial location of the second leg,
the delivery device comprising
a proximal end and a distal end, the proximal end comprising a handle,
a shaft extending from the handle to the distal end and having a longitudinal axis, the distal end comprising
a magazine comprising a first magazine channel extending along a length of the distal end and a second magazine channel extending along a length of the distal end parallel to the first magazine channel, and wherein the anchor can be held in the magazine with the first leg located in the first magazine channel and the second leg located in the second magazine channel, and
a staging location on a distal side of the magazine comprising a first staging space and a second staging space, wherein the anchor can be held in the staging location with the first leg located in the first staging space and the second leg located in the second staging space, and wherein the staging location is moveable relative to the magazine,
a rotatable staging disc at the distal end, distal to the magazine, the rotatable staging disc comprising a staging slot as the staging location that includes the first staging space and the second staging space, and that is rotatable about an axis of the shaft between a first staging position and a second staging position, and a hollow sharpened needle distal to the staging disc and extending parallel to a longitudinal axis of the shaft, wherein in the first staging position the slot aligns with the anchor held in the magazine, in the second staging position the first elongate leg of the anchor aligns with the sharpened hollow needle; and
an ejector actuatable at the handle to eject a soft tissue anchor from the staging location.
2. The device and anchor of claim 1 wherein the first elongate leg has a length in a range from about 0.1 to about 1 inch, the second elongate leg has a length in a range from about 0.1 to about 1 inch, and the tie has a length in a range from about 0.1 to about 1 inch.
3. The device and anchor of claim 1 wherein the anchor comprises flexible plastic and the anchor does not become permanently deformed when ejected by the soft tissue anchor delivery device.
4. The device and anchor of claim 1 wherein the distal end can be placed through a laparoscopic cannula to be located at a region of supportive tissue.
5. The device and anchor of claim 1 wherein the magazine is capable of holding a series of soft tissue anchors located in longitudinal alignment, the series comprising a distal soft tissue anchor and a proximal soft tissue anchor, wherein when located in the magazine a longitudinal axis of the first arm of the proximal soft tissue anchor is aligned with a longitudinal axis of the first arm of the distal soft tissue anchor, and a longitudinal axis of the second arm of the proximal soft tissue anchor is aligned with a longitudinal axis of the second arm of the distal soft tissue anchor.
6. The device and anchor of claim 1 wherein the magazine is capable of holding a series of soft tissue anchors located in longitudinal alignment, the series comprising
a distal soft tissue anchor comprising a first elongate leg and a second elongate leg connected by an elongate tie, each elongate leg comprising a distal end and a proximal end,
a proximal soft tissue anchor comprising a first elongate leg and a second elongate leg connected by an elongate tie, each elongate leg comprising a distal end and a proximal end, with a proximal end of each elongate leg of the distal soft tissue anchor being joined to a distal end of each elongate leg of the proximal soft tissue anchor.
7. The device and anchor of claim 6 wherein: if the distal soft tissue anchor is located in the staging location, and the proximal soft tissue anchor is located in the magazine, with the proximal end of an elongate leg of the distal soft tissue anchor being joined to the distal end of an elongate leg of the proximal soft tissue anchor, moving the staging location relative to the magazine would cause the proximal end of the elongate leg of the distal soft tissue anchor to break from the distal end of the elongate leg of the proximal soft tissue anchor.
8. A method of placing a soft tissue anchor at anatomical tissue, the method comprising
providing a device and soft tissue anchor as recited at claim 1 ,
placing the distal end of the device at a location of anatomical tissue,
ejecting the soft tissue anchor from a distal end of the device to place a portion of the soft tissue anchor in the anatomical tissue.
9. A method as recited at claim 8 comprising inserting the distal end through a surgical incision.
10. A method as recited at claim 9 wherein the method comprises treating a pelvic condition,
the pelvic condition is a condition of a male or female patient selected from the group consisting of: a condition of levator tissue; urinary incontinence; fecal incontinence; hernia; a prolapse condition; and vaginal vault prolapse; and
the surgical incision is selected from a vaginal incision, a perineal incision, an open abdominal incision, and a laparoscopic incision.
11. A method as recited at claim 9 wherein the method is a sacral colpopexy comprising using the soft tissue anchor delivery device laparoscopically to place an anchor at a region of a sacral anatomy to hold an implant material at the region of sacral anatomy, or to place an anchor at vaginal tissue to hold an implant material at the vaginal tissue.
12. A method as recited at claim 8 comprising ejecting a leg of the anchor from the distal end to:
pass the first leg of the anchor and a portion of the tie through implant material, and
pass the first leg of the anchor and a portion of the tie into tissue such that the second leg remains external to the tissue and holds the implant material at the tissue.
13. A method as recited at claim 8 comprising simultaneously ejecting the first leg and the second leg of the implant from the distal end to:
pass the first leg of the anchor and a portion of the tie through implant material, and
pass the second leg of the anchor and a portion of the tie through the implant material, and
pass the first leg of the anchor and the second leg of the anchor into tissue such that a portion of the tie remains external to the tissue and holds the implant material at the tissue.
14. The device and anchor of claim 1 wherein a longitudinal axis of the second staging space is not aligned with a longitudinal axis of the second magazine channel.
15. A device and anchor of claim 1 wherein: the shaft has the longitudinal axis, the first magazine channel is located at a distance from the shaft longitudinal axis, and the first staging space is located at a different distance from the shaft longitudinal axis.
16. A device and anchor of claim 1 wherein: the shaft has a longitudinal axis, the first magazine channel is located at an angle about the shaft longitudinal axis, and the first staging channel is located at a different angle about the shaft longitudinal axis.
17. A soft tissue anchor delivery device adapted to contain a soft tissue anchor,
the soft tissue anchor comprising a first elongate leg, a second elongate leg, and a tie connecting the first elongate leg to the second elongate leg, wherein the tie comprises a first tie end connected to the first leg at a medial location, and a second tie end connected to the second leg at a medial location of the second leg,
the delivery device comprising
a proximal end and a distal end, the proximal end comprising a handle,
a shaft extending from the handle to the distal end, the distal end comprising
a magazine, and
a staging location on a distal side of the magazine, and
an ejector actuatable at the handle to eject a soft tissue anchor from the staging location,
wherein the distal end comprises
a rotatable staging disc distal to the magazine, the rotatable staging disc comprising a staging slot rotatable about an axis of the shaft between a first staging position and a second staging position; and
a hollow sharpened needle distal to the staging disc and extending parallel to a longitudinal axis of the shaft,
wherein in the first staging position the slot aligns with the anchor held in the magazine, in the second staging position a leg of the anchor aligns with the sharpened hollow needle.
18. The device of claim 17 wherein the anchor comprises flexible plastic and the anchor does not become permanently deformed when ejected by the soft tissue anchor delivery device.
19. The device of claim 17 wherein the distal end can be placed through a laparoscopic cannula to be located at a region of supportive tissue.
20. The device of claim 17 wherein the distal end comprises a pin capable of aligning the rotatable staging disc in a desired position.