IP Library Granted Patent US 12,035,904
Granted Patent B2
US 12,035,904 · App. 17/188,578 · Granted Jul 16, 2024

Endoscopic tissue approximation system and methods

Inventors: Vladimir Mitelberg (Austin, TX); Donald K. Jones (Dripping Springs, TX); Brian Szymczak (Austin, TX)
Assignee: Boston Scientific Scimed, Inc.
A61B17/0469A61B2017/0409A61B2017/0441A61B2017/0443
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Quick Facts
Patent No.
US 12,035,904
App. No.
17/188,578
Granted
Jul 16, 2024
Kind
B2
Abstract

A deployment system includes a sheath, a shaft having a handle positioned at its proximal end, a micro motor having a motor shaft at the shafts distal end, a detachable helical first suture anchor positioned at the motor shafts distal end and an elongate suture fixedly coupled to the suture anchor. The deployment system can be positioned at a first tissue, and the motor shaft rotated to advance the helical first suture anchor into engagement with the first tissue. The motor shaft is detached from the first suture anchor thereby deploying it at the first tissue location. The deployment system can be reloaded with multiple suture anchors to deploy at multiple tissue locations. The suture extending between the anchors can then be drawn together to reconfigure the coupled tissue.

Claims (41)

1. An endoscopic deployment system for placing a suture anchor at a site within a mammal comprising:

an elongated flexible delivery member having proximal, intermediate and distal regions, proximal and distal ends, an elongate shaft member having proximal and distal ends, a handle coupled to said proximal end of the elongate shaft member, a micro motor positioned at the distal end of the elongate shaft member and having a motor shaft, a plurality of electrical conductors extending from the handle to the micro motor such that when energy is supplied through said plurality of electrical conductors to said micro motor, said micro motor operates to rotate said motor shaft;

a coupling assembly fixedly coupled to a distal end of said motor shaft including an engagement post; and

a suture anchor having proximal and distal ends, a receiver having a central longitudinal axis, a coil member positioned at said distal end of said suture anchor, and a suture eyelet rotatable relative to said receiver,

said elongated flexible delivery member having first and second operable configurations wherein when in said first operable configuration said suture anchor is releasably coupled to said coupling assembly whereby said engagement post couples with said receiver and rotation of said motor shaft results in rotation of said suture anchor such that when said suture anchor is in contact with tissue, rotation of said motor shaft causes the coil member of said suture anchor to engage the tissue, and wherein in said second operable configuration said suture anchor is detached from said coupling assembly, said elongated flexible delivery member being operable between said first and second operable configurations.

2. An endoscopic deployment system according to claim 1 , wherein said handle is operable to supply energy through said plurality of electrical conductors to said micro motor, which results in rotation of said motor shaft.

3. An endoscopic deployment system according to claim 1 wherein said handle includes, i) a stationary member defining a power supply receptacle, and a switch assembly; ii) a power supply positioned in said power supply receptacle having a plurality of electrical connectors that connect said power supply to said switch assembly; and iii) said plurality of electrical connectors that connect said switch assembly to said plurality of electrical conductors such that when said switch assembly is operated energy is supplied from said power supply though said electrical conductors to said micro motor causing said motor shaft to rotate.

4. An endoscopic deployment system according to claim 1 further comprising a sheath having proximal and distal ends, said sheath extending over said elongate shaft member such that the distal end of said sheath is located proximal to said suture anchor, said handle actuatable to move said sheath distally over said elongate shaft member so as to dislodge said suture anchor from said engagement post.

5. An endoscopic deployment system according to claim 4 wherein said handle includes a longitudinally displaceable slide assembly coupled the proximal end of said sheath and said longitudinally displaceable slide assembly is actuatable to move said sheath distally over said elongate shaft member.

6. An endoscopic deployment system according to claim 1 further comprising a suture anchor release surface located proximal to said suture anchor, said handle actuatable to move the suture anchor release surface distal into contact against a proximal surface of said suture anchor to disengage said suture anchor from said engagement post.

7. An endoscopic deployment system according to claim 1 wherein said elongate flexible delivery member is sufficiently flexible to be positioned through a tortuous path.

8. An endoscopic deployment system according to claim 1 wherein the distal region of the said elongate flexible delivery member includes a first rotation key, and said suture anchor includes a second rotation key, wherein said first and second rotation keys rotationally interfere with each other.

9. An endoscopic deployment system according to claim 1 wherein said engagement post includes at least one recess, and said suture anchor includes at least one tab, and when said engagement post is coupled with said receiver said at least one tab and at least one recess rotationally interfere such that axial rotation of said engagement post results in rotation of said suture anchor.

10. An endoscopic deployment system according to claim 1 wherein said engagement post includes one of a recess and tab, and said suture anchor includes the other of a recess and a tab, and when said engagement post is coupled with said receiver said tab and recess rotationally interfere such that axial rotation of said engagement post results in rotation of said suture anchor.

11. An endoscopic deployment system according to claim 1 wherein said suture anchor consists of a tubular member and said suture eyelet, said tubular member defining both said receiver and said coil member.

12. An endoscopic deployment system according to claim 1 wherein said suture anchor coil member is tapered.

13. An endoscopic deployment system according to claim 1 wherein said suture anchor coil member has a variable pitch.

14. A method of deploying a suture anchor into tissue, comprising: a) providing an endoscopic deployment system having a proximal end and distal end, the deployment system including, i) a handle, ii) an elongate shaft member having a proximal end and a distal end and defining a longitudinal axis, the proximal end of the elongate shaft member coupled to the handle, and the distal end of the elongate shaft member including a micro motor having a motor shaft, iii) a suture anchor having a coil distal end with a tissue piercing distal tip, removably coupled to a distal end of the motor shaft, such that rotation of the motor shaft results in rotation of the coil distal end, wherein when the tissue piercing distal tip of the coil distal end is rotated against tissue the tissue piercing distal tip of the coil distal end is adapted to pierce and engage the tissue; b) positioning the distal end of the deployment system adjacent a first tissue location; c) rotating the coil distal end about the longitudinal axis to advance the coil into engagement with the first tissue location; and d) retracting the elongate shaft member to uncouple the suture anchor from the elongate shaft member and thereby deposit the suture anchor at the first tissue location.

15. The method according to claim 14 , further comprising: after rotating the coil distal end about the longitudinal axis to advance the coil distal end into engagement with the first tissue location and before retracting the elongate shaft member to uncouple the suture anchor from the elongate shaft member and thereby deposit the suture anchor at the first tissue location; rotating the coil distal end about the longitudinal axis in an opposite direction to withdraw the coil distal end from engagement with the first tissue location; re-positioning the distal end of the deployment system adjacent a second tissue location; and rotating the coil distal end about the longitudinal axis to advance the coil distal end into engagement with the second tissue location.

16. The method according to claim 14 , wherein: the endoscopic deployment system includes a plurality of suture anchors, and further comprising, for each suture anchor to be deployed, positioning the distal end of the endoscopic deployment system adjacent a respective tissue location; rotating the coil distal end about the longitudinal axis to advance the coil distal end into engagement with the respective tissue location; and retracting the elongate shaft member to uncouple the suture anchor from the shaft member and thereby deposit the suture anchor at the respective tissue location.

17. The method according to claim 16 , wherein: the plurality of suture anchors are coupled to a common suture, and applying tension on the common suture between the deposited plurality of suture anchors to reconfigure the first and respective tissue locations relative to each other, and then retaining the applied tension to the common suture.

18. A method of deploying a suture anchor into tissue, comprising:

a) providing an endoscopic deployment system having a proximal end and distal end, the deployment system including,

i) a handle,

ii) an elongate shaft member having a proximal end and a distal end and defining a longitudinal axis, the proximal end of the elongate shaft member coupled to the handle, and the distal end of the elongate shaft member including a micro motor having a motor shaft fixedly coupled to an engagement post,

iii) a sheath having a proximal end coupled to the handle and a distal end, the sheath extending over the elongate shaft member, and

iv) a suture anchor having a coil distal end with a tissue piercing distal tip, removably coupled to the engagement post at the distal end of said elongate shaft member, such that rotation of the motor shaft results in rotation of the coil distal end, wherein when the tissue piercing distal tip of the coil distal end is rotated against tissue the tissue piercing distal tip of the coil distal end is adapted to pierce and engage the tissue;

b) positioning the distal end of the endoscopic deployment system adjacent a first tissue location;

c) rotating the coil distal end about the longitudinal axis to advance the coil distal end into engagement with the first tissue location; and

d) advancing the sheath relative to the elongate shaft member to cause the distal end of the sheath to push against the suture anchor and thereby uncouple the suture anchor from the engagement post and thereby deposit the suture anchor at the first tissue location.

19. A method according to claim 18 , wherein the sheath is a longitudinally stiff construct.

20. A kit for tissue approximation through a working channel of an endoscope, comprising:

a) an endoscopic deployment system including,

i) a handle, and

ii) an elongate shaft member having a proximal end and a distal end and defining a longitudinal axis, the proximal end of the elongate shaft member coupled to the handle, and the distal end of the elongate shaft member including a micro motor having a motor shaft fixedly coupled to an engagement post, the elongate shaft member sized for insertion through the working channel of the endoscope;

b) a plurality of suture anchors, each suture anchor having a coil distal end with a tissue piercing distal tip, removably couplable to the engagement post at the distal end of the shaft member, such that rotation of the motor shaft results in rotation of the coil distal end, wherein when the tissue piercing distal tip of the coil distal end is rotated against tissue the tissue piercing distal tip of the coil distal end is adapted to pierce and engage the tissue; and

c) suture pre-extending through the plurality of anchors.

21. A kit according to claim 20 wherein one of the plurality of suture anchors is mounted on the engagement post and at least one of the plurality of suture anchors is provided in a device for separate handling and subsequent mounting to the engagement post.

22. A kit according to claim 21 wherein the plurality of suture anchors are retained the device for separate handling which includes a plurality of respective holders, and the plurality of respective holders are mounted on a card.

23. A kit according to claim 22 further comprising: an endoscope bracket adapted to couple the endoscopic deployment system to the endoscope, wherein the bracket supports the card.

24. A kit according to claim 20 further comprising: a channel liner adapted to extend through the working channel of the endoscope prior to insertion of the endoscopic deployment system and form a barrier between the endoscopic deployment system and the working channel when the endoscopic deployment system is subsequently inserted into the working channel.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 1, 2023
From: APOLLO ENDOSURGERY US, INC.
To: APOLLO ENDOSURGERY, INC.
Reel/Frame 065416/0670 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 1, 2023
From: APOLLO ENDOSURGERY, INC.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 065416/0947 →
TERMINATION AND RELEASE OF INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Apr 5, 2023
From: APOLLO ENDOSURGERY, INC.; APOLLO ENDOSURGERY US, INC.; APOLLO ENDOSURGERY INTERNATIONAL, LLC; LPATH THERAPEUTICS, INC.
To: INNOVATUS LIFE SCIENCES LENDING FUND I, LP
Reel/Frame 063264/0046 →
SECURITY INTEREST Recorded Dec 23, 2021
From: APOLLO ENDOSURGERY, INC.; APOLLO ENDOSURGERY US, INC. (F/K/A LPATH, INC.)
To: INNOVATUS LIFE SCIENCES LENDING FUND I, LP
Reel/Frame 058980/0199 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 1, 2021
From: MITELBERG, VLADIMIR; JONES, DONALD K.; SZYMCZAK, BRIAN
To: APOLLO ENDOSURGERY US, INC.
Reel/Frame 055446/0989 →
Continuity (2)
Provisional Application 62984492 · Mar 3, 2020
Related Publication 20210275166A1 · Sep 9, 2021