U.S. patent application number 12/577044 was filed with the patent office on 2010-05-13 for termination devices and related methods.
Invention is credited to Charles J. Adam, Tenny C. Calhoun, Mariel Fabro, John P. Lunsford, Ann T. Meier, Stephen C. Meier, Stephen Olson, Eugene Serina, Tammy Y. Tam, Brian Tang.
Application Number | 20100121349 12/577044 |
Document ID | / |
Family ID | 42100982 |
Filed Date | 2010-05-13 |
United States Patent
Application |
20100121349 |
Kind Code |
A1 |
Meier; Stephen C. ; et
al. |
May 13, 2010 |
TERMINATION DEVICES AND RELATED METHODS
Abstract
Devices and methods for locking and/or cutting tethers during a
tissue modification procedure are described. In some variations, a
tether may be used to tighten tissue by bringing two pieces or
sections of the tissue together. The tether, which may be under
tension, may be locked to maintain the tension, and excess tether
may be severed, using one or more of the devices and/or methods.
The devices and/or methods may be used, for example, in minimally
invasive procedures.
Inventors: |
Meier; Stephen C.; (Santa
Clara, CA) ; Serina; Eugene; (Union City, CA)
; Adam; Charles J.; (San Jose, CA) ; Fabro;
Mariel; (San Jose, CA) ; Tam; Tammy Y.; (San
Francisco, CA) ; Lunsford; John P.; (San Carlos,
CA) ; Calhoun; Tenny C.; (Sunnyvale, CA) ;
Tang; Brian; (Fremont, CA) ; Olson; Stephen;
(Los Altos, CA) ; Meier; Ann T.; (Santa Clara,
CA) |
Correspondence
Address: |
MORRISON & FOERSTER LLP
755 PAGE MILL RD
PALO ALTO
CA
94304-1018
US
|
Family ID: |
42100982 |
Appl. No.: |
12/577044 |
Filed: |
October 9, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61104681 |
Oct 10, 2008 |
|
|
|
Current U.S.
Class: |
606/139 ;
606/232 |
Current CPC
Class: |
A61B 17/0487 20130101;
A61B 2017/0496 20130101; A61B 17/0644 20130101; A61B 2017/00243
20130101; A61B 2017/0488 20130101; A61B 17/0485 20130101; A61B
2017/00783 20130101; A61B 17/083 20130101; A61B 17/10 20130101;
A61B 17/0467 20130101; A61B 2017/045 20130101; A61B 17/068
20130101; A61B 2017/0451 20130101; A61B 2017/320052 20130101 |
Class at
Publication: |
606/139 ;
606/232 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A device for securing a tether comprising: a locking member
configured to receive a plug and comprising a proximal end, a
distal end, and a lumen therethrough; and a plug rotatable within
the lumen of the locking member to secure a portion of a tether
within the lumen, the plug comprising an exterior surface, wherein
the locking member comprises a wall portion comprising an interior
surface, and wherein the exterior surface of the plug has at least
one contour alignable with the interior surface of the wall portion
when the plug is at least partially disposed within the lumen of
the locking member.
2. The device of claim 1, further comprising an elongated member
comprising a distal portion to which the locking member is
releasably coupled.
3. The device of claim 1, wherein the wall portion of the locking
member comprises first and second apertures alignable for passage
of a tether therethrough.
4. The device of claim 3, wherein the first and second apertures
are located such that a tether passing therethrough would not cross
the center of the lumen of the locking member.
5. The device of claim 1, wherein the locking member comprises a
tubular member.
6. The device of claim 1, wherein the plug is rotatable by at least
about 1.degree. to secure a portion of a tether within the lumen of
the locking member.
7. The device of claim 6, wherein the plug is rotatable by at most
about 180.degree. to secure a portion of a tether within the lumen
of the locking member.
8. The device of claim 1, wherein the plug is rotatable by at most
about 180.degree. to secure a portion of a tether within the lumen
of the locking member.
9. The device of claim 1, wherein the plug is rotatable within the
lumen of the locking member by tensioning a tether passing through
the lumen of the locking member.
10. The device of claim 1, further comprising a pullwire for
rotating the plug within the lumen of the locking member.
11. The device of claim 1, further comprising a cutting member
configured to cut a tether.
12. The device of claim 1, wherein the plug comprises at least one
protrusion configured to engage a portion of a tether within the
lumen of the locking member.
13. The device of claim 12, wherein the at least one protrusion is
in the form of at least one ridge.
14. The device of claim 1, wherein the plug comprises multiple
protrusions that form a stepped configuration.
15. The device of claim 1, wherein the plug comprises a gear-shaped
portion.
16. The device of claim 15, wherein the gear-shaped portion
comprises a plurality of teeth, each tooth being progressively
longer than the previous tooth.
17. A method for securing a tether when at least a portion of the
tether is disposed within a lumen of a locking member, the method
comprising: tensioning the tether to rotate a plug at least
partially disposed within the lumen of the locking member, wherein
the locking member comprises a wall portion having an interior
surface, and the plug comprises an exterior surface having at least
one contour which is aligned with the interior surface of the wall
portion when the plug is rotated.
18. The method of claim 17, further comprising advancing the plug
at least partially into the lumen of the locking member.
19. The method of claim 17, wherein the wall portion of the locking
member comprises first and second apertures, and the method
comprises rotating the plug when the tether passes through the
first and second apertures.
20. The method of claim 17, wherein rotating the plug secures the
portion of the tether between the exterior surface of the plug and
the interior surface of the wall portion of the locking member.
21. The method of claim 17, wherein the locking member comprises a
tubular member.
22. The method of claim 17, wherein tensioning the tether rotates
the plug by at least about 1.degree..
23. The method of claim 22, wherein tensioning the tether rotates
the plug by at most about 180.degree..
24. The method of claim 17, wherein tensioning the tether rotates
the plug by at most about 180.degree..
25. The method of claim 17, wherein the locking member is
releasably coupled to a distal portion of an elongated member.
26. The method of claim 25, further comprising decoupling the
locking member from the distal portion of the elongated member.
27. The method of claim 26, wherein decoupling the locking member
from the distal portion of the elongated member comprises applying
force to the locking member with a pushing member.
28. The method of claim 17, further comprising cutting the
tether.
29. A device for securing a tether comprising: a locking member
configured to receive a plug and comprising a wall portion
comprising first and second apertures and a proximal end, a distal
end, and a lumen therethrough; and a plug comprising a third
aperture alignable with the first and second apertures for passage
of a tether therethrough.
30. The device of claim 29, wherein the third aperture can be
misaligned from at least one of the first and second apertures to
secure a tether passing therethrough.
31. A method for securing a tether using a device comprising a
locking member comprising a wall portion, a proximal end, a distal
end, and a lumen therethrough, and a plug comprising first and
second apertures, the method comprising: advancing the plug at
least partially into the lumen of the locking member when the
tether has been routed through the first and second apertures to
secure the tether between the plug and the locking member.
32. The method of claim 31, further comprising advancing the tether
through the first aperture.
33. The method of claim 32, wherein the tether is advanced through
the first aperture while the plug is at least partially disposed
within the lumen of the locking member.
34. The method of claim 32, further comprising advancing the tether
through the second aperture.
35. The method of claim 32, wherein the tether is advanced through
the second aperture while the plug is at least partially disposed
within the lumen of the locking member.
36. A device for securing a tether comprising: a locking member
comprising a wall portion, a proximal end, a distal end, and a
lumen therethrough; and a plug comprising at least one protrusion
configured to engage a groove or first aperture in the wall portion
of the locking member when the plug is at least partially disposed
within the lumen of the locking member, wherein the plug and the
locking member are configured to secure a tether therebetween.
37. The device of claim 36, wherein the at least one protrusion of
the plug is configured to form a snap-fit with the groove or first
aperture in the wall portion of the locking member.
38. A method for securing a tether using a device comprising a plug
and a locking member comprising a wall portion having an interior
surface, a proximal end, a distal end, and a lumen therethrough,
the method comprising: at least partially fitting the plug within
the lumen of the locking member; and engaging a groove or first
aperture in the plug with at least one protrusion on the interior
surface of the wall portion of the locking member while a portion
of the tether is disposed within the lumen of the locking member to
secure the tether between the plug and the locking member.
39. The method of claim 38, wherein the at least one protrusion on
the interior surface of the wall portion of the locking member
forms a snap-fit with the groove or first aperture in the plug.
40. A device for securing a tether comprising: a locking member
comprising a wall portion, a proximal end, a distal end, and a
lumen therethrough; and a plug comprising a body portion and a head
portion comprising a one-way feature allowing translation of the
head portion in a first direction once within the lumen of the
locking member, but not in a second direction opposite the first
direction, wherein the plug and the locking member are configured
to secure a tether therebetween when the plug is at least partially
disposed within the lumen of the locking member.
41. The device of claim 40, further comprising a pushing member
configured to push the plug in the first direction.
42. A device for securing a tether comprising: a locking member
configured to receive a plug and comprising a wall portion, a
proximal end, a distal end, and a lumen therethrough; and a plug
comprising a body portion and an anchor portion extending from the
body portion, wherein the plug and the locking member are
configured to secure a tether therebetween.
43. The method of claim 42, further comprising advancing the anchor
portion into tissue so that the anchor portion engages the
tissue.
44. A method for securing a tether using a locking member
comprising a first portion having a first surface and a second
portion having a second surface, the first and second portions
coupled to each other by a hinge, the method comprising:
positioning the tether on one of the first and second surfaces when
the first surface is not in contact with the second surface; and
contacting the first surface with the second surface to secure a
portion of the tether between the first and second portions of the
locking member.
45. A device for securing a tether comprising: a locking member
configured to receive a plug and comprising a proximal end, a
distal end, and a lumen therethrough; a plug; and a coupling member
extending between the plug and the locking member to couple the
plug to the locking member.
46. A method for securing a tether using a locking member and a
clamping member slidably disposed within the lumen of the locking
member, the method comprising: clamping the tether with the
clamping member; and withdrawing the clamping member into the lumen
of the locking member.
47. A method for securing a first tether using a plug comprising a
first ring portion and a locking member comprising a wall portion,
a proximal end, a distal end, and a lumen therethrough, the method
comprising: advancing the plug at least partially into the lumen of
the locking member to secure the first tether between the plug and
the wall portion of the locking member; passing a second tether
through the first ring portion; and securing the second tether to
tissue of a subject.
48. The method of claim 47, wherein the locking member further
comprises a second ring portion, and the method further comprises
passing the second tether through the second ring portion.
49. The method of claim 48, further comprising securing the second
tether to tissue of the subject.
50. The device of claim 47, wherein the plug further comprises a
second ring portion, and the method further comprises passing the
second tether through the second ring portion.
51. The method of claim 50, further comprising securing the second
tether to tissue of the subject.
52. The method of claim 47, wherein the first and second tethers
are the same tether.
53. The method of claim 47, wherein the first tether passes through
at least one aperture in the wall portion of the locking
member.
54. A method for securing a first tether using a plug and a locking
member comprising a wall portion, a first ring portion, a proximal
end, a distal end, and a lumen therethrough, the method comprising:
advancing the plug at least partially into the lumen of the locking
member to secure the first tether between the plug and the wall
portion of the locking member; passing a second tether through the
first ring portion; and securing the second tether to tissue of a
subject.
55. The method of claim 54, wherein the locking member further
comprises a second ring portion, and the method further comprises
passing the second tether through the second ring portion.
56. The method of claim 55, further comprising securing the second
tether to tissue of the subject.
57. The method of claim 54, wherein the first and second tethers
are the same tether.
58. The method of claim 54, wherein the first tether passes through
at least one aperture in the wall portion of the locking
member.
59. A method for securing a tether comprising: advancing the tether
through a tubular member while the tubular member is at least
partially disposed within a hollow region of a locking member in an
open configuration; and withdrawing the tubular member from the
hollow region without also withdrawing the tether from the hollow
region, wherein the locking member assumes a closed configuration
when the tubular member has been withdrawn from the hollow region,
such that the locking member clamps down on the tether and thereby
secures the tether.
60. A method for securing a tether comprising: advancing the tether
through a coil while the coil is in a primary configuration and at
least partially disposed within a lumen of a tubular member; and
translating the coil relative to the tubular member so that the
coil exits the lumen of the tubular member and assumes a secondary
configuration in which the coil secures the tether.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/104,681, filed Oct. 10, 2008, the disclosure of
which is incorporated herein by reference in its entirety.
FIELD
[0002] The devices and methods described herein relate generally to
termination of tethers that have been deployed to a target site in
a body of a subject. More specifically, the devices and methods
described herein relate to locking and/or cutting such tethers
after they have been deployed to the target site.
BACKGROUND
[0003] Many different types of medical procedures involve the use
of tethers. For example, tethers may be used to tighten or compress
tissue (e.g., by bringing two pieces or sections of tissue
together). The tissue may be, for example, soft tissue, such as
muscle tissue or fat tissue. As an example, in some tissue
tightening procedures, anchors coupled to a tether are embedded in
tissue, and the tether is then pulled upon to provide a cinching
effect that tightens or compresses the tissue via the anchors.
Examples of devices and methods for such procedures applied to
heart valve repair are described, for example, in U.S. Patent
Application Publication Nos. US 2006/0122633 A1, US 2006/0190030
A1, and US 2008/0172035 A1, all of which are hereby incorporated by
reference in their entirety.
[0004] Some methods of tissue tightening or compression include
threading a tether through two pieces of tissue, applying tension
to the tether, and tying off or knotting the tether to maintain the
tension. Extra tether material may then be cut and removed.
However, the manipulation required when knotting, tying, and/or
cutting a tether can be difficult (e.g., because of restricted
space). Moreover, certain methods may not adequately maintain
tension in a tether. Additionally, some methods of knotting, tying,
and/or cutting a tether may be unduly complicated and/or
time-consuming.
[0005] Accordingly, it would be desirable to provide methods and
devices for effectively locking and/or cutting a tether to help
maintain tension in the tether. It would further be desirable for
such methods and devices to be relatively easy and/or efficient to
use.
SUMMARY
[0006] Described here are devices and methods for locking and/or
cutting tethers, such as tethers that have been used to tighten or
compress tissue (e.g., by pulling two or more pieces or sections of
the tissue together).
[0007] Certain variations of the devices described here comprise a
locking member (e.g., a tubular member) configured to receive a
plug within a lumen, and a plug rotatable within the lumen of the
locking member to secure a portion of a tether within the lumen.
The exterior surface of the plug may have at least one contour
(e.g., a curvature) alignable with the interior surface of a wall
portion of the locking member when the plug is at least partially
disposed within the lumen of the locking member.
[0008] The wall portion of the locking member may comprise first
and second apertures alignable for passage of a tether
therethrough. The first and second apertures may be located such
that a tether passing therethrough would not cross the center of
the lumen of the locking member. The plug may be rotatable within
the lumen of the locking member by tensioning a tether passing
through the lumen of the locking member. The plug may be rotatable
by at least about 1.degree. (e.g., at least about 10.degree., at
least about 20.degree., at least about 45.degree., at least about
90.degree., at least about 135.degree.) and/or at most about
180.degree. (e.g., at most about 135.degree., at most about
90.degree., at most about 45.degree., at most about 20.degree., at
most about 10.degree.) to secure a portion of a tether within the
lumen of the locking member. The devices may further comprise a
pullwire for rotating the plug within the lumen of the locking
member. The plug may comprise at least one protrusion (e.g., in the
form of at least one ridge) configured to engage a portion of a
tether within the lumen of the locking member. In certain
variations, the plug may comprise multiple protrusions. For
example, the plug may comprise multiple protrusions that form a
stepped configuration. In some variations, the plug may comprise a
gear-shaped portion, such as a gear-shaped portion comprising a
plurality of teeth, with each tooth being progressively longer than
the previous tooth.
[0009] Certain variations of the methods described here may
comprise tensioning a tether when at least a portion of the tether
is disposed within the lumen of the locking member. Tensioning the
tether may rotate the plug when the plug is at least partially
disposed within the lumen of the locking member. In some
variations, the methods may comprise rotating the plug when the
tether passes through first and second apertures in the wall
portion of the locking member. Rotating the plug may secure the
portion of the tether between the exterior surface of the plug and
the interior surface of the wall portion of the locking member. The
methods may further comprise advancing the plug at least partially
into the lumen of the locking member.
[0010] Some variations of the devices described here may comprise a
locking member (e.g., a tubular member) configured to receive a
plug and comprising a wall portion comprising first and second
apertures and a lumen. The devices may further comprise a plug
comprising a third aperture alignable with the first and second
apertures for passage of a tether therethrough. The third aperture
may be capable of being misaligned from at least one of the first
and second apertures to secure a tether passing therethrough. The
tether may be secured, for example, between the plug and the wall
portion of the locking member. The plug may comprise at least two
apertures.
[0011] Certain variations of the methods described here may
comprise adjusting the relative position of the locking member and
the plug when the plug is at least partially disposed within the
lumen of the locking member. This may secure a tether passing
through the first and second apertures in the wall portion of the
locking member and the third aperture in the plug. The methods may
further comprise advancing the plug at least partially into the
lumen of the locking member. In some variations, the methods may
further comprise advancing the tether through the first aperture in
the wall portion of the locking member, through the second aperture
in the plug, and/or through the third aperture in the wall portion
of the locking member. The tether may be secured between the plug
and the locking member.
[0012] Some variations of the devices described here may comprise a
locking member (e.g., a tubular member) comprising a wall portion
and a lumen, and a plug comprising first and second apertures. The
plug may be configured to at least partially fit within the lumen
of the locking member, and the first and second apertures may be
configured such that a tether routed therethrough will be secured
between the plug and the locking member. In certain variations, the
plug may be secured within the locking member prior to securing the
tether.
[0013] Some variations of the methods described here may comprise
advancing the plug at least partially into the lumen of the locking
member when the tether has been routed through the first and second
apertures to secure the tether between the plug and the locking
member. The plug may be secured to the locking member prior to
being used to secure a tether. The methods may further comprise
advancing the tether through the first and/or second apertures
(e.g., while the plug is at least partially disposed within the
lumen of the locking member and/or while the plug is secured with
the locking member).
[0014] Certain variations of the devices described here may
comprise a locking member (e.g., a tubular member) comprising a
wall portion and a lumen, and a plug comprising at least one
protrusion configured to engage a groove or first aperture in the
wall portion of the locking member when the plug is at least
partially disposed within the lumen of the locking member, where
the plug and the locking member are configured to secure a tether
therebetween. The protrusion on the plug may be configured to form
a snap-fit with the groove or first aperture in the wall portion of
the locking member. At least a portion of the plug may be
configured to be compressed to fit within the locking member, and
then released to form a snap-fit with the locking member. The
device may further comprise a pushing member configured to push the
plug toward the locking member. In some variations, the plug may
comprise a second aperture. The wall portion of the locking member
may comprise a third aperture that is alignable with the second
aperture of the plug for routing of a tether therethrough.
[0015] Some variations of the methods described here may comprise
advancing the plug into the lumen of the locking member while a
portion of a tether is disposed within the lumen of the locking
member, until at least one protrusion on the plug engages the
groove or first aperture in the wall portion of the locking member.
Advancing the plug into the lumen of the locking member may secure
the portion of the tether between the plug and the locking member.
The protrusion on the plug may form a snap-fit with the groove or
first aperture in the wall portion of the locking member. The
methods may further comprise advancing the tether through a second
aperture in the plug after the protrusion has engaged the groove or
first aperture in the wall portion of the locking member. In
certain variations, the methods may comprise advancing the plug
into the lumen of the locking member until the plug is entirely
disposed within the lumen of the locking member.
[0016] Some variations of the devices described here may comprise
an elongated member and a tubular member coupled to a distal
portion of the elongated member, the tubular member comprising a
lumen. The tubular member may further comprise a wall portion
comprising at least one non-circular aperture sized and shaped for
passage of a tether therethrough, and/or at least one circular
aperture sized and shaped for passage of a tether therethrough. The
non-circular aperture may be horseshoe-shaped, for example.
[0017] Certain variations of the methods described here may
comprise routing the tether through the non-circular aperture in
the wall portion of the tubular member when the tubular member is
coupled to a distal portion of an elongated member. Routing the
tether through the non-circular aperture may compress the
tether.
[0018] Some variations of the devices described here may comprise a
locking member (e.g., a tubular member) comprising a wall portion
and a lumen, and a plug configured to at least partially fit within
the lumen of the locking member. The interior surface of the wall
portion may comprise at least one protrusion configured to engage a
groove or first aperture in the plug when the plug is at least
partially disposed within the lumen of the locking member.
Additionally, the plug and the locking member are configured to
secure a tether therebetween. The protrusion on the interior
surface of the wall portion of the locking member may be configured
to form a snap-fit with the groove or first aperture in the plug.
The devices may further comprise a pushing member configured to
push the plug toward the locking member. In certain variations, the
plug may further comprise a second aperture. The wall portion of
the locking member may comprise a third aperture that is alignable
with the second aperture of the plug for passage of a tether
therethrough.
[0019] Some variations of the methods described here may comprise
at least partially fitting the plug within the lumen of the locking
member and engaging the groove or first aperture in the plug with
the protrusion on the interior surface of the wall portion of the
locking member while a portion of the tether is disposed within the
lumen of the locking member. This may, for example, secure the
tether between the plug and the locking member. The protrusion may
form a snap-fit with the groove or first aperture in the plug. The
protrusion may comprise a lip or rim on the interior surface of the
locking member. The methods may further comprise advancing the plug
into the lumen of the locking member until the plug is entirely
disposed within the lumen of the locking member.
[0020] Certain variations of the devices described here may
comprise a locking member (e.g., a tubular member) comprising a
wall portion and a lumen, and a plug comprising a body portion and
a head portion comprising a one-way feature. The one-way feature
may allow translation of the head portion in a first direction once
within the lumen of the locking member, but not in a second
direction opposite the first direction. The plug and the locking
member may be configured to secure a tether therebetween when the
plug is at least partially disposed within the lumen of the locking
member. The devices may further comprise a pushing member
configured to push the plug in the first direction. The plug may
comprise at least one aperture configured for passage of a tether
therethrough.
[0021] Some variations of the methods described here may comprise
advancing the plug into the lumen of the locking member until the
plug is at least partially disposed within the lumen of the locking
member, to secure the tether between the plug and the locking
member.
[0022] Certain variations of the devices described here may
comprise a locking member configured to receive a plug and
comprising a wall portion and a lumen, and a plug comprising a body
portion and an anchor portion extending from the body portion,
where the plug and the locking member are configured to secure a
tether therebetween. The devices may further comprise a pushing
member configured to push the plug into the lumen of the locking
member.
[0023] Certain variations of the methods described here may
comprise advancing the plug into the lumen of the locking member
until the plug is at least partially disposed within the lumen, to
secure a tether between the plug and the locking member. The
methods may further comprise advancing the anchor portion into
tissue so that the anchor portion engages the tissue.
[0024] Some variations of the devices described here may comprise a
locking member comprising a first portion having a first surface
and a second portion having a second surface, the first and second
portions coupled to each other by a hinge (e.g., a living hinge).
The locking member may have an open configuration in which the
first surface does not contact the second surface and a closed
configuration in which the first surface contacts the second
surface, and may be configured to secure a tether between the first
and second surfaces in the closed configuration. The first and
second surfaces may be configured to couple to each other upon
contacting each other. For example, the first surface may comprise
a groove or aperture and the second surface may comprise at least
one protrusion configured to engage the groove or aperture when the
first surface contacts the second surface. At least one of the
first and second surfaces may be textured. The first and second
surfaces may be minor images of each other.
[0025] Certain variations of the methods described here may
comprise positioning a tether on one or both of the first and
second surfaces when the first surface is not in contact with the
second surface, and contacting the first surface with the second
surface to secure a portion of the tether between the first and
second portions of the locking member. The methods may further
comprise coupling the first surface to the second surface, and/or
cutting the tether.
[0026] Some variations of the devices described here may comprise a
plug, a locking member (e.g., a tubular member) comprising a lumen
configured to receive a plug, and a coupling member extending
between the plug and the locking member to couple the plug to the
locking member. The coupling member may be integral with the
locking member and/or the plug. The coupling member may comprise a
tether. Some variations of the methods described here may comprise
advancing the plug at least partially into the lumen of the locking
member when a portion of a tether is disposed within the lumen of
the locking member to secure the portion of the tether between the
plug and the wall portion of the locking member. The tether may
pass through at least one aperture in the wall portion of the
locking member.
[0027] Some of the devices described here may comprise a locking
member (e.g., a tubular member) comprising a lumen and a clamping
member slidably disposed within the lumen of the locking member.
The clamping member may be configured to be advanced from, and
withdrawn into, the lumen of the locking member, and may also be
configured to clamp a tether when withdrawn into the locking
member. In some variations, the clamping member may comprise jaws.
Certain variations of the methods described here may comprise
clamping a tether with the clamping member, and withdrawing the
clamping member into the lumen of the locking member.
[0028] Some variations of the devices described here may comprise a
locking member (e.g., a tubular member) comprising a lumen, and a
plug comprising at least two coupling portions configured to couple
the plug to the locking member, and to advance the plug into the
lumen of the locking member. Certain variations of the methods
described here may comprise coupling the plug to the locking member
and advancing the plug into the lumen of the locking member to
thereby secure a tether between the plug and the wall portion of
the locking member. The tether may pass through at least one
aperture in the wall portion of the locking member. The methods may
further comprise cutting the tether.
[0029] Some variations of the devices described here may comprise a
locking member (e.g., a tubular member) comprising a wall portion
and a lumen, and a plug configured to at least partially fit within
the lumen of the locking member. The plug may comprise at least one
hook configured to engage a groove or aperture in an exterior
surface of the wall portion of the locking member. The plug may
also be configured to secure a tether against the interior surface
of the wall portion of the locking member when the plug is at least
partially disposed within the lumen of the locking member.
[0030] Certain method variations may comprise advancing the plug at
least partially into the lumen of the locking member to secure a
tether between the plug and the wall portion of the locking member,
and engaging the hook of the plug with the groove or aperture in
the exterior surface of the wall portion of the locking member to
secure the plug to the locking member. The tether may pass through
at least one aperture in the wall portion of the locking
member.
[0031] Some device variations may comprise a locking member (e.g.,
a tubular member) comprising a wall portion and a lumen, and a plug
configured to at least partially fit within the lumen of the
locking member to secure a tether between the plug and the wall
portion of the locking member. The plug may comprise a first ring
portion configured for passage of a tether therethrough, and at
least a portion of the first ring portion may be external to the
lumen of the locking member when the plug is at least partially
disposed within the lumen of the locking member. The locking member
may further comprise a second ring portion configured for passage
of a tether therethrough.
[0032] Some of the method variations may comprise advancing the
plug at least partially into the lumen of the locking member to
secure a first tether between the plug and the wall portion of the
locking member, passing a second tether through the first ring
portion, and securing the second tether to tissue of a subject. The
locking member may further comprise a second ring portion, and the
method may further comprise passing the second tether through the
second ring portion. The plug may further comprise a second ring
portion, and the method may further comprise passing the second
tether through the second ring portion. The method may also
comprise securing the second tether to tissue of the subject. The
first and second tethers may be the same tether. The first tether
may pass through at least one aperture in the wall portion of the
locking member.
[0033] Some variations of the devices may comprise a locking member
(e.g., a tubular member) comprising a wall portion and a lumen, and
a plug configured to at least partially fit within the lumen of the
locking member to secure a tether between the plug and the wall
portion of the locking member. The locking member may further
comprise a first ring portion configured for passage of a tether
therethrough. The first ring portion may extend from the wall
portion of the locking member. The locking member may further
comprise a second ring portion configured for passage of a tether
therethrough.
[0034] Some variations of the methods described here may comprise
advancing the plug at least partially into the lumen of the locking
member to secure a first tether between the plug and the wall
portion of the locking member, passing a second tether through the
first ring portion, and securing the second tether to tissue of a
subject. The locking member may further comprise a second ring
portion, and the method may further comprise passing the second
tether through the second ring portion. The method may also
comprise securing the second tether to tissue of the subject. The
first and second tethers may be the same tether. The first tether
may pass through at least one aperture in the wall portion of the
locking member.
[0035] Some variations of the devices may comprise a tubular member
and a locking member comprising a first clamping portion, a second
clamping portion, and a hollow region therebetween. The hollow
region may be configured to receive at least a portion of the
tubular member when the locking member is in an open configuration.
The locking member may also have a closed configuration in which
the hollow region is not configured to receive any portion of the
tubular member and in which the first clamping portion clamps
against the second clamping portion. The first clamping portion may
comprise a first plurality of teeth and the second clamping portion
may comprise a second plurality of teeth that contact the first
plurality of teeth when the locking member is in the closed
configuration.
[0036] Some method variations may comprise advancing a tether
through the tubular member while the tubular member is at least
partially disposed within the hollow region of the locking member
in an open configuration, and withdrawing the tubular member from
the hollow region without also withdrawing the tether from the
hollow region. The locking member may assume a closed configuration
when the tubular member has been withdrawn from the hollow region,
such that the locking member clamps down on the tether and thereby
secures the tether.
[0037] Certain device variations may comprise a tubular member
comprising a lumen, and a coil having a primary configuration when
at least partially disposed within the lumen of the tubular member.
The coil may be configured to assume a secondary configuration when
not disposed within the lumen of the tubular member. Additionally,
the coil may be configured for advancement of a tether therethrough
when the coil is in its primary configuration, and may be
configured to secure the tether when the coil assumes its secondary
configuration. Some method variations may comprise advancing a
tether through the coil while the coil is in a primary
configuration and at least partially disposed within the lumen of
the tubular member, and translating the coil relative to the
tubular member so that the coil exits the lumen of the tubular
member and assumes a secondary configuration in which the coil
secures the tether.
[0038] Certain variations of the devices described herein may
comprise an elongated member (e.g., a catheter). Moreover, in some
variations of devices comprising a locking member, the locking
member may be releasably coupled to a distal portion of the
elongated member. Certain method variations may comprise decoupling
the locking member from the distal portion of the elongated member
(e.g., by applying force to the locking member with a pushing
member). Some variations of the devices described herein may
comprise a cutting member configured to cut a tether. Methods may
comprise cutting one or more tethers.
[0039] Certain device variations may comprise a plug comprising a
body with a proximal portion and a distal portion, a locking member
comprising a proximal portion and a distal portion, and a cutting
member that is coupled to or integral with the plug body. The
locking member may further comprise a lumen extending at least
partially therethrough, where the lumen is sized and shaped to
receive the plug. In some variations, the plug may form a friction
fit with the lumen of the locking member. The locking member may
also comprise a wall portion with at least one aperture that is
sized and shaped for passage of a tether therethrough. In some
cases, the locking member may alternatively or additionally
comprise a stop shoulder in the distal portion of the lumen. The
cutting member may be located in the proximal or distal portion of
the plug, and/or may surround at least a portion of the external
surface of the plug body. In certain variations, the plug may
comprise a collet comprising a cutting member. Some variations of
devices may further comprise a pushing member that may be
configured to push the plug into the lumen of the locking member.
In certain variations, the pushing member may comprise a cutting
member. In some such variations, the pushing member may be used
both to push a plug and to cut a tether.
[0040] Certain device variations may comprise a plug comprising a
body with a proximal portion and a distal portion, and a locking
member comprising a proximal portion, a distal portion, and a lumen
extending at least partially therethrough, where the locking member
may be configured to receive the plug and form a friction-fit with
the plug within the lumen. In some variations, the locking member
may comprise a first cutting member. The locking member may further
comprise a wall portion comprising at least one aperture sized and
shaped for passage of a tether therethrough. In some variations,
the first cutting member may be located in the distal portion of
the locking member, and may have an aperture sized and shaped for
passage of a tether therethrough. In certain variations, the first
cutting member may surround at least a portion of an internal
surface of the lumen of the locking member.
[0041] In certain device variations, the plug may further comprise
a second cutting member that may be coupled to or integral with the
plug body. The second cutting member may substantially contact the
first cutting member when the plug is received within the lumen of
the locking member. The device may also include a tether guide that
may be configured to draw a tether passing through the lumen of the
locking member transversely with respect to a longitudinal axis of
the lumen.
[0042] Some variations of devices may comprise a plug comprising a
body having proximal and distal portions, a locking member
comprising proximal and distal portions and a lumen extending at
least partially therethrough, and a pushing member comprising a
plug-contacting portion and a cutting member. The locking member
lumen may be configured to receive and form a friction-fit with the
plug, and the pushing member may be configured to push the plug
into the lumen of the locking member. The locking member may
further comprise a wall portion comprising at least one aperture
sized and shaped for passage of a tether therethrough. In some
variations, the cutting member may be in the form of at least one
shear edge on the body of the pushing member, and/or may be
arranged symmetrically with respect to the plug-contacting portion
of the pushing member. The shear edge or edges may also surround at
least a portion of the external perimeter of the pushing member.
The pushing member may have a first configuration in which the
cutting member is covered and a second configuration in which the
cutting member is uncovered or exposed.
[0043] Some variations of methods described here may comprise
advancing a plug comprising a cutting member partially into a lumen
of a locking member to secure a tether passing through the lumen,
and advancing the plug further into the lumen to cut the tether.
The tether may be secured between a wall of the plug and a wall of
the lumen.
[0044] Certain variations of the methods described here may
comprise advancing a plug partially into a lumen of a locking
member to secure a tether passing through the lumen, and advancing
the plug further into the lumen of the locking member to cut the
tether. The tether may be cut, for example, by coming into contact
with a cutting member disposed in the lumen of the locking
member.
[0045] Some method variations may comprise advancing a plug
comprising a first cutting member partially into a lumen of a
locking member to secure a tether between a wall of the plug and a
wall of the lumen, and advancing the plug further into the lumen of
the locking member, such that the first cutting member contacts a
second cutting member disposed within the lumen of the locking
member, and thereby cuts the tether.
[0046] Some method variations may comprise using a pushing member
to advance a plug partially into a lumen of a locking member to
secure a tether passing through the lumen, where the pushing member
comprises a cutting member. The tether may be secured, for example,
between a wall of the plug and a wall of the lumen. The methods may
also comprise advancing the pushing member until the cutting member
contacts a portion of the locking member (e.g., the distal or
proximal portion) and cuts the tether. In certain variations, the
cutting member may contact and cut the tether as it exits at a
shoulder of the proximal portion of the locking member.
[0047] Some method variations may comprise using a pushing member
coupled to a plug to advance the plug partially into a lumen of a
locking member to thereby secure a tether passing through the
lumen. The tether may be secured, for example, between a wall of
the plug and a wall of the lumen. In certain variations, the
pushing member may comprise a cutting member. In such variations,
the methods may, for example, further comprise advancing the
pushing member until the cutting member contacts a portion of the
locking member and cuts it. In some variations, the cutting member
may cut the tether at a side aperture of the lumen of the locking
member where the tether exits. In certain variations, the cutting
member may contact and cut the tether as it exits at a shoulder in
the lumen of the locking member.
[0048] Certain method variations described here may comprise using
a pushing member to advance a plug partially into a lumen of a
locking member and to thereby secure a tether passing through the
lumen of the locking member. The tether may be secured, for
example, between a wall of the plug and a wall of the lumen. In
some variations, the locking member may comprise at least two
apertures sized and shaped for passage of a tether therethrough. In
certain variations, a cutting member may be coupled to the plug,
and the methods may further comprise pushing the plug to advance
the cutting member to contact a shoulder of the locking member and
cut the tether.
[0049] Some method variations may comprise using a first pushing
member to advance a plug partially into a lumen of a locking member
to secure a tether passing through the lumen, where a proximal
portion of the plug is coupled to an extendable cutting member. In
some such variations, a second pushing member may be used to
advance the extendable cutting member and thereby cut the
tether.
BRIEF DESCRIPTION OF THE DRAWINGS
[0050] FIGS. 1A and 1B illustrate the tightening or compression of
tissue of a subject using a tether.
[0051] FIG. 2 shows a variation of a device for locking a
tether.
[0052] FIGS. 3A-3D show variations of a device and a method for
locking a tether.
[0053] FIGS. 4A and 4B show another variation of a device for
locking a tether.
[0054] FIGS. 5A-5H depict variations of a device and method for
locking a tether, FIGS. 5I-5P show variations of components of
devices for locking a tether, and FIGS. 5Q-5X depict additional
variations of a device and method for locking a tether.
[0055] FIGS. 6 and 7 are side cross-sectional views of variations
of devices for locking a tether.
[0056] FIG. 8 is a side view in partial cross-section of an
additional variation of a device for locking a tether.
[0057] FIGS. 9A and 9B depict variations of a device and a method
for locking a tether.
[0058] FIGS. 10 and 11 are side cross-sectional views of variations
of devices for locking a tether.
[0059] FIG. 12 is a side view in partial cross-section of another
variation of a device for locking a tether.
[0060] FIGS. 13 and 14 are side cross-sectional views of variations
of devices for locking a tether.
[0061] FIG. 15 is a side cross-sectional view of a variation of a
component of a device for locking a tether.
[0062] FIGS. 16A and 16B are perspective views of a variation of a
device for locking a tether.
[0063] FIGS. 17A and 17B are perspective views of a variation of a
device for locking a tether, FIG. 17C is a side view of the device
of FIGS. 17A and 17B, FIG. 17D is a side perspective view of the
device of FIGS. 17A-17C, FIGS. 17E and 17F are front views of the
device of FIG. 17D, and FIG. 17G is a side cross-sectional view of
the device of FIGS. 17A-17F.
[0064] FIGS. 18A and 18B are top views of a variation of a device
for locking a tether.
[0065] FIG. 19A is a perspective view of a variation of a device
for locking a tether, FIG. 19B is a side view of the device of FIG.
19A, FIG. 19C is a front view of the device of FIGS. 19A and 19B
when the components of the device are coupled to each other, FIG.
19D is a side cross-sectional view of the device of FIGS. 19A-19C,
and FIG. 19E is a top view of the device of FIGS. 19A-19D.
[0066] FIG. 20A is a side view of a variation of a device that may
be used to cut a tether, and FIG. 20B is a cross-sectional view of
the device of FIG. 20A, taken along line 20B-20B.
[0067] FIG. 20C is a side view of a variation of a device that may
be used to cut a tether, and FIG. 20D is a cross-sectional view of
the device of FIG. 20C, taken along line 20D-20D.
[0068] FIG. 20E is a side view of a variation of a device that may
be used to cut a tether, and FIG. 20F is a cross-sectional view of
the device of FIG. 20E, taken along line 20E-20F.
[0069] FIG. 20G is a side view of a variation of a device that may
be used to cut a tether, and FIG. 20H is a cross-sectional view of
the device of FIG. 20G, taken along line 20H-20H.
[0070] FIGS. 21A, 21B, and 22-25 are side views in partial
cross-section of variations of devices for locking a tether.
[0071] FIG. 26A is a side view of a variation of a device for
locking a tether, and FIG. 26B is a perspective view of the device
of FIG. 26A.
[0072] FIG. 27A is a side view of another variation of a device for
locking a tether, and FIG. 27B is a perspective view of the device
of FIG. 27A.
[0073] FIG. 28A is a side view of an additional variation of a
device for locking a tether, and FIG. 28B is a perspective view of
the device of FIG. 28A.
[0074] FIG. 29A is a side view of another variation of a device for
locking a tether, and FIG. 29B is a perspective view of the device
of FIG. 29A.
[0075] FIG. 30A is a side view of a variation of a component of a
device for locking a tether, and FIGS. 30B and 30C are side views
in partial cross-section of a device for locking a tether that
comprises the component of FIG. 30A.
[0076] FIG. 31A and FIG. 31B are side perspective views of
variations of a device for locking a tether.
[0077] FIG. 32 depicts variations of a device and a method for
locking a tether.
[0078] FIGS. 33A-33E illustrate variations of a device for locking
a tether.
[0079] FIGS. 34A-34C depict variations of a device and a method for
locking a tether.
[0080] FIGS. 35A-35D show variations of a device for locking a
tether.
[0081] FIG. 36 shows a variation of a device for locking a
tether.
[0082] FIG. 37 is a perspective view of a variation of a device for
locking a tether.
[0083] FIG. 38 is a side view of a variation of a device for
locking a tether.
[0084] FIGS. 39A-39E are side views of variations of components of
a device for locking a tether.
[0085] FIG. 40A is a side perspective view of a variation of a
device for locking a tether, and FIGS. 40B and 40C are side views
in partial cross-section of the device of FIG. 40A.
[0086] FIG. 41 is a side view in partial cross-section of another
variation of a device for locking a tether.
[0087] FIG. 42A is a perspective view of a variation of a component
of a device for locking a tether, FIG. 42B depicts a device
comprising the component of FIG. 42A, and FIGS. 42C-42G illustrate
a variation of a method for locking a tether using a device
comprising the component of FIG. 42A.
[0088] FIGS. 43A and 43B are perspective views of variations of
devices for locking a tether.
[0089] FIGS. 44A and 44B are side views in partial cross-section of
different variations of devices that may be used to lock a
tether.
[0090] FIGS. 44C and 44D are side views of variations of components
of devices that may be used to lock a tether.
[0091] FIG. 44E is a side view in partial cross-section of a
variation of a device that may be used to lock a tether.
[0092] FIGS. 45A-45F illustrate variations of a device and method
that may be used to lock a tether.
[0093] FIG. 45G is an exploded view of another variation of a
device that may be used to lock a tether.
[0094] FIGS. 46A and 46B are partial cross-sectional views of a
variation of a device that may be used to lock a tether.
[0095] FIGS. 46C and 46D are perspective views of variations of
devices for locking a tether.
[0096] FIG. 47A is a perspective view of a variation of a device
for locking a tether, and FIG. 47B is a side view of the device of
FIG. 47A.
[0097] FIGS. 48 and 49 are perspective views of variations of
devices for locking a tether.
[0098] FIGS. 50A and 50B depict further variations of a device and
a method for locking a tether.
[0099] FIG. 50C is a perspective view of a tether and a variation
of a tether-locking device, FIG. 50D is a front cross-sectional
view of the tether and device of FIG. 50C, taken along line
50D-50D, FIG. 50E is a schematic view of the device of FIG. 50C
when flattened, and FIG. 50F is an illustrative depiction of the
device of FIG. 50C when it is being used to lock a tether.
[0100] FIGS. 51A and 51B illustrate variations of a device and a
method for locking a tether.
[0101] FIG. 52 shows a variation of a tether comprising an integral
locking feature.
[0102] FIGS. 53A and 53B depict variations of a device and a method
for locking a tether.
[0103] FIG. 54 depicts variations of a device and a method for
locking a tether.
[0104] FIG. 55 illustrates another variation of a device for
locking a tether.
[0105] FIGS. 56A and 56B depict variations of a device and a method
for locking a tether.
[0106] FIG. 57 illustrates variations of a device and a method for
locking a tether.
[0107] FIGS. 58A and 58B are illustrative variations of devices for
loading tethers into catheters.
[0108] FIGS. 58C and 58D are cross-sectional views of exemplary
variations of tether-threading devices.
[0109] FIG. 59A is a perspective view of a variation of a device
that may be used to lock a tether, and FIG. 59B is a
cross-sectional view of the device of FIG. 59A, taken along line
59B-59B.
[0110] FIGS. 60A-60R show various tether-routing configurations
through variations of components of tether-locking devices.
[0111] FIGS. 61A-61F illustrate various examples of devices that
may be used to cut a tether.
[0112] FIG. 62 is a side view in partial cross-section of a
variation of a device for cutting a tether.
[0113] FIGS. 63A and 63B depict examples of devices that may be
used to cut a tether.
[0114] FIGS. 64A-64D illustrate variations of devices that may be
used to cut a tether.
[0115] FIGS. 65A and 65B show additional variations of devices that
may be used to cut a tether.
[0116] FIG. 65C illustrates a variation of a device that may be
used to cut a tether.
[0117] FIGS. 66A and 66B are perspective views of a variation of a
device that may be used to cut a tether.
[0118] FIGS. 66C and 66D are side views of additional variations of
devices that may be used to cut a tether.
[0119] FIGS. 67A and 67B show different variations of devices that
may be used to lock and cut a tether.
[0120] FIG. 68A is a side view in partial cross-section of one
variation of a device and method that may be used to lock and cut a
tether, FIGS. 68B and 68C are side perspective views of different
variations of devices that may be used to lock and cut a tether,
FIGS. 68D-68G are side views of different variations of devices
that may be used to lock and cut a tether, and FIGS. 68H-68J are
side perspective views of additional variations of devices that may
be used to lock and cut a tether.
[0121] FIG. 69A is a side perspective view in partial cross-section
of a variation of a device that may be used to lock and cut a
tether, FIG. 69B is a side view of a variation of a component of a
device that may be used to lock and cut a tether, and FIG. 69C is a
side perspective view of a variation of a component of a device
that may be used to lock and cut a tether.
[0122] FIG. 70A is a side perspective view in partial cross-section
of a variation of a device that may be used to lock and cut a
tether, and FIG. 70B is a side view in partial cross-section of a
variation of a component of a device that may be used to lock and
cut a tether.
[0123] FIG. 71 is a side view in partial cross-section of
variations of a device and method that may be used to lock and cut
a tether.
[0124] FIGS. 72A and 72B are side views in partial cross-section of
different variations of devices that may be used to lock and cut a
tether.
[0125] FIGS. 73A and 73B are illustrative side views in partial
cross-section of variations of a device and method that may be used
to lock and cut a tether.
[0126] FIGS. 73C and 73D are illustrative side views in partial
cross-section of additional variations of a device and method that
may be used to lock and cut a tether.
[0127] FIGS. 74A and 74B are cross-sectional views of different
variations of devices and methods that may be used to lock and cut
a tether.
[0128] FIGS. 75A and 75B are side views in partial cross-section of
variations of a device and method that may be used to lock and cut
a tether.
[0129] FIG. 76 is a side view in partial cross-section of
variations of a device and method that may be used to lock and cut
a tether.
DETAILED DESCRIPTION
[0130] Described here are methods and devices for locking and/or
cutting a tether (e.g., after the tether has been tensioned to
tighten or compress tissue). The devices and methods described here
may be used in any appropriate procedure and location for which
such tether locking and/or cutting is desired. While not so
limited, the devices and methods described here may be used, for
example, in Natural Orifice Transluminal Endoscopic Surgery
("NOTES") procedures, heart valve repair procedures (e.g., mitral
valve annulus repair procedures), and/or endoscopic procedures
(e.g., laparoscopy and/or arthroscopy). The devices and methods
described here may be used in non-invasive or minimally invasive
procedures (e.g., minimally invasive percutaneous procedures), or
in invasive procedures, such as invasive surgeries (e.g.,
open-heart surgeries), as appropriate. Some of the devices
described here may be used to lock or cut a tether, while other
devices described here may be used to both lock and cut a tether.
Specific examples of methods and devices will now be described in
further detail below.
[0131] Turning now to the figures, FIG. 1A shows two anchors (100)
and (104) anchored into tissue (106) of a subject. A tether (110)
is fixedly attached to anchor (100), and is threaded through a loop
region (114) of anchor (104). As shown in FIG. 1B, when tether
(110) is pulled upon in the direction of arrow (A1), a cinching
effect results, such that anchors (100) and (104) are brought
closer together, and the tissue length between anchors (100) and
(104) is reduced. In this way, tissue (106) may be gathered and/or
compressed. While two anchors are shown in FIGS. 1A and 1B, in some
cases multiple anchors may be used. Additionally, the anchors may
all have the same size and shape, or may have different sizes
and/or shapes. After tether (110) has been tensioned by a desired
amount, tether (110) may be locked to maintain the tension, and in
some cases, excess portions of tether (110) may be cut and
removed.
[0132] The above-described process may be used in a wide variety of
tissues. For example, in some variations, anchors that are
connected to each other by a tether may be deployed into tissue in
the region of a mitral valve annulus. The tether may then be pulled
upon to provide a cinching effect, which restructures the mitral
valve annulus (e.g., to reduce mitral valve regurgitation).
Thereafter, a locking device may be used to lock the tether in
place, thereby maintaining the cinching effect. Finally, a cutting
device may be used to remove excess portions of the tether. Mitral
valve repair is described, for example, in U.S. Patent Application
Publication Nos. US 2006/0122633 A1, US 2006/0190030 A1, US
2008/0172035 A1, and US 2008/0177380 A1, all of which are hereby
incorporated by reference in their entirety.
[0133] In certain variations, the above-described process may be
used in a heart reshaping procedure, such as a ventricular
remodeling procedure that is used to repair a heart experiencing
valve dysfunction. Heart repair procedures, including heart
reshaping procedures, are described, for example, in U.S. patent
application Ser. No. 12/253,792, filed on Oct. 17, 2008, which is
hereby incorporated by reference in its entirety.
[0134] As discussed above, the devices and methods described herein
may be used, as appropriate, in any of a number of different sites
within the body and/or to assist with any of a number of different
types of procedures. As an example, the devices and methods
described herein may be used in NOTES procedures. As another
example, the devices and methods described herein may be used in
heart procedures other than those involving mitral valve repair.
For example, they may be used to repair an aortic valve or a
tricuspid valve, or to secure a prosthetic heart valve, or they may
be used in heart ports. As another example, the devices and methods
may be employed in a procedure in which one or more tethers are
used to reinforce an annuloplasty ring. Additionally, the devices
and methods described herein may be used, for example, in a variety
of open surgical procedures.
[0135] Anchors for use with the methods and devices described here
may be any suitable anchor. The anchors may be made of any suitable
material, may be any suitable size, and may be of any suitable
shape. The anchors may be made of one material or more than one
material. Examples of anchor materials include super-elastic or
shape memory materials, such as nickel-titanium alloys and spring
stainless steel. Examples of anchor shapes include T-tags, rivets,
staples, hooks (e.g., C-shaped or semicircular hooks, curved hooks
of other shapes, straight hooks, barbed hooks), multiple looped
anchors, clips, and the like. The anchors may be configured to
self-expand and self-secure into tissue, but need not be configured
in such a fashion. Multiple anchors of the same shape may be used,
or multiple anchors having different shapes may be used. Similarly,
multiple anchors of the same size may be used, or multiple anchors
having different sizes may be used. Illustrative examples of
suitable anchors are described in more detail, for example, in U.S.
Patent Application Publication Nos. US 2005/0273138 A1, US
2008/0045982 A1, US 2008/0045983 A1, US 2008/0051810 A1, and US
2008/0051832 A1, and US 2008/0058868 A1, all of which are hereby
incorporated by reference in their entirety. Moreover, while
anchors have been described, any other type of suitable fasteners
or implants (e.g., leads, electrodes, etc.) may be used with one or
more of the devices and/or methods described here. Additionally,
some procedures employing the devices and methods described herein
may not involve any anchors or other types of fasteners. As an
example, certain variations of the devices and methods described
here may be used to lock and/or cut a suture that has been sewn
through tissue.
[0136] Tethers may be one long piece of material or two or more
pieces, and may comprise any suitable material, such as suture,
suture-like material, a DACRON.RTM. polyester strip, high-density
polyethylene (HDPE), or the like. In some variations, tethers may
be in the form of monofilament or multifilament textile yarns or
fibers. Tethers may also have various braided textile
configurations. While a procedure for tightening or compressing
tissue using one tether has been described, other procedures for
modifying tissue may involve the use of multiple tethers, such as
two, three, four, five, or ten tethers. When multiple tethers are
used, at least some of the tethers may be associated with (e.g.,
fixedly attached to) different anchors, and/or at least some of the
tethers may be associated with (e.g., fixedly attached to) the same
anchor. The devices and methods described herein may apply to
single tether procedures, or to multiple tether procedures. As an
example, a locking and/or cutting device may be used to lock and/or
cut more than one tether, either simultaneously, or at different
times.
[0137] As described above, after one or more anchors have been
secured and the tether has been tensioned, the tether may then be
locked or secured into place to maintain the tension (and,
therefore, the cinching effect). Different variations of locking
devices are described in further detail below.
[0138] For example, FIG. 2 shows a locking device (201) including a
locking element (205) comprising a plug (213) and a hollow locking
member (206). Hollow locking member (206) is releasably coupled to
a tubular elongated member (203) in a distal region of the device.
Elongated member (203) may be flexible over all or a portion of its
length. As shown in FIG. 2, hollow locking member (206) is in the
form of a distal extension of elongated member (203) (i.e., hollow
locking member (206) extends beyond the distal end of elongated
member (203)). However, in some variations, a locking device may
comprise an elongated member and a locking member that is coupled
to the elongated member, but that does not form a distal extension
of the elongated member. Referring again to FIG. 2, hollow locking
member (206) maintains the profile of elongated member (203), and
may share a common wall with the elongated member. In some cases,
though, a locking device may comprise an elongated member and a
locking member that is smaller or larger than the elongated member
in profile. Alternatively or additionally, the elongated member and
the locking member may not share a common wall.
[0139] While the device shown in FIG. 2 is configured as a
catheter, other configurations may be used. Moreover, the device
may be scaled up (e.g., for use in a surgical procedure) or down
(e.g., for use in a minimally invasive procedure), depending, for
example, on the requirements of the particular procedure in which
the device is to be used.
[0140] As shown in FIG. 2, a tether (210) is threaded through the
distal region of locking device (201), particularly through hollow
locking member (206). Although any suitable locking element may be
included as part of a locking device, locking element (205) locks a
tether when plug (213) is advanced into hollow locking member (206)
such that the tether is secured between the plug and a wall of the
locking member. As shown, tether (210) is threaded through multiple
apertures in the wall (212) of hollow locking member (206).
However, in some variations, a tether may be threaded through only
one aperture in a wall of a locking member. Alternatively or
additionally, a tether may pass through one or more apertures
(e.g., passages or holes) in one or more other locations of a
locking device (e.g., distally of the locking element). In certain
variations, one or more apertures through which a tether is routed
may be radiused (e.g., to enhance passage of the tether through the
aperture or apertures).
[0141] Until the locking element is secured, the device may be
moved along the tether (e.g., by sliding), or the tether may be
pulled through the device. Thus, the tether may be used to provide
a cinching effect by sliding the device distally down the tether.
The apertures through the device shown in FIG. 2 may be positioned
such that the device can still easily slide along the tether. In
some variations, the tether may be threaded into the locking
element in such a way that it winds in and out of the locking
element, as suggested by FIG. 2.
[0142] The tether may be threaded or coupled to the device during
manufacturing or by the user. For example, and as described further
below, a lasso may be threaded through the apertures in the device.
The lasso may then be used to engage the tether and to thread the
tether through the apertures (e.g., by pulling on the opposite end
of the lasso).
[0143] In some variations, the device may be slid along the tether
until the tether has been pulled by the desired amount through the
anchors, at which point the tether may be secured into position
using the locking element. For example, and as described above,
tether (210) of FIG. 2 may be secured into position by pushing plug
(213) into hollow locking member (206) of locking element (205)
(e.g., as a result of an interference fit between the plug and the
locking member). In the variation shown in FIG. 2, plug (213)
secures tether (210) by compressing at least a portion of the
tether between the plug and the inner walls of hollow locking
member (206).
[0144] In some variations, a device may comprise a plug and a
hollow locking member, at least one of which comprises one or more
features that limit the likelihood of the plug being released from
the hollow locking member. For example, the plug and/or hollow
locking member may include adhesive, glue, or cement, and/or may be
at least partially deformable so that once the plug has been
inserted into the hollow locking member, the plug is retained
within the locking member. As an example, the plug may comprise a
material which is compressible or elastic to aid in locking the
plug into the locking member. In certain variations, the plug may
have polygonal (e.g., hexagonal) sides that interact with the inner
surface of the locking member. The plug may be solid or hollow. The
plug may have bumps, dimples, ribs, grooves, or holes on its
surface to increase friction with the tether. The locking member
may also include or comprise one or more structures (e.g., rims,
brackets, etc.) to help hold the plug in the locked configuration.
In some variations, the locking member itself may alternatively or
additionally be polygonal in cross-section. In certain variations,
the plug and the locking member may have corresponding geometries,
as described below. In some variations of devices, the plug and the
locking member may each include different features that enhance the
retention of the plug in the locking member.
[0145] The device shown in FIG. 2 further includes a pushing member
(215) for pushing plug (213) into position to secure tether (210)
within hollow locking member (206). The pushing member (shown in
FIG. 2 as a rod, although other suitable forms of pushing members
may be used) may be slidable within the lumen of the device. In
some variations, the pushing member may include one or more guides
(e.g., that guide the pushing member's direction) and/or one or
more stops (e.g., that limit the distance traveled by the pushing
member and/or the force applied by the pushing member). Thus, there
may be motion-limiting features on the device and/or pushing member
to prevent the pushing member from being pushed too far forward, or
from applying too much force, which could disturb either the
locking element or the tissue (e.g., after separation of the
locking element from the rest of the device).
[0146] As described above, a locking element may be releasably
coupled to the rest of a device. Any appropriate method may be used
to provide such a releasable coupling. In some variations, the
locking element (or a portion thereof) may include a releasable
coupling region, such as a region that can be separated or broken
to release the locking element from the rest of the device. As an
example, a locking element may be frangibly connected to the rest
of a device, and may be decoupled from the device by breaking the
frangible connection. For example, a locking element may be fused
to another portion of the device (e.g., a distal portion of an
elongated member). The fused region may later be broken to decouple
the locking element from the other portion of the device. The
amount of heat and/or pressure that is applied during the fusion
process, as well as the number of fused regions and their
locations, may be selected so that a specific amount of force can
be applied to the fused regions to break them.
[0147] Different regions of a locking device may comprise different
materials, or may comprise the same material. In some variations, a
locking device may comprise a locking element formed of a first
material, another portion formed of a second material, and a fused
region between the locking element and the other portion that is
formed of a third material (or combination of materials). Using
different materials for different regions of a locking device may
be advantageous if the different regions have different material
requirements. For example, a more distal region of the device may
be formed of one or more materials that provide relative
flexibility, while a more proximal region may be formed of one or
more materials that provide relative stiffness, or vice-versa.
Moreover, while locking devices comprising one or more fused
regions and multiple different materials have been described, some
variations of locking devices may comprise fused regions and may be
formed entirely of one material or combination of materials, and
other variations of locking devices may comprise multiple different
materials (e.g., two, three, four, or five different materials)
without comprising any fused regions.
[0148] In certain variations, a locking device may comprise a
detachable locking element that is coupled to the rest of the
device by a structurally weakened region. The structurally weakened
region may, for example, be scored, etched, perforated, fractured,
creased, slotted, and/or dimpled. An example of a perforated region
(220) is shown in FIG. 2. The locking element may be made of the
same material as the rest of the device, or the locking element and
the rest of the device may be made of different materials. When a
sufficient amount of force is applied to the structurally weakened
region, the locking element may become separated from the rest of
the device. Force may be applied to the structurally weakened
region using, for example, a pushing member or any other suitable
mechanism.
[0149] In some variations, a locking element may be releasably
coupled to another portion of a locking device via at least one
adhesive and/or a friction fit, so that the application of a
certain amount of force causes the locking element to decouple from
the other portion of the locking device. Additional non-limiting
methods of releasably coupling a locking element to another portion
of a locking device include fusing, brazing, soldering, and
snap-locking. In some variations of locking devices, two or more
different releasable coupling methods may be used in conjunction
with each other.
[0150] As described above, in certain variations, a locking element
may be controllably decoupled from the rest of a device by applying
a force. Force may be applied in any appropriate manner (e.g.,
pushing on a pushing member, hydraulic force (using saline, water,
or the like), magnetic force, pressurized gas, etc.). For example,
the same pushing member (215) of FIG. 2, used to push plug (213)
and secure the locking element, may also be used to decouple the
locking element from the rest of the device (e.g., by pushing the
pushing member with additional force). In some variations, one
force applicator (e.g., a pushing member) may be used to secure the
locking element and another force applicator (e.g., a second
pushing member) may be used to decouple the locking element from
the rest of the device.
[0151] The amount of force required to decouple a locking element
from the rest of a device may be predetermined. In variations where
the same force applicator (e.g., a pushing member, fluid line,
magnet, etc.) is used both to lock the tether and to decouple the
locking element, the force required to decouple the locking element
may be greater than the force required to secure the locking
element and thereby lock the tether. For example, a device may be
configured for its locking element to decouple after the
application of greater than about 2 lbs of force, greater than
about 3 lbs of force, greater than about 4 lbs of force, greater
than about 5 lbs of force, greater than about 10 lbs of force,
greater than about 20 lbs of force, or between about 2 lbs and
about 5 lbs of force. The amount of force that is needed to
decouple a locking element from the rest of a locking device can
depend on any of a number of different factors. Such factors may
include, for example, the thickness of the coupling region, the
material or materials that form the coupling region, and/or the
location of scoring, perforations, or other weakened points in the
coupling region. In some cases, the amount of force that is
required to decouple a locking element from the rest of a locking
device, as well as the way in which the force is applied to
decouple the locking element, may be controlled to prevent damage
to the locking element, the tether, the anchors, and/or the
surrounding tissue.
[0152] While the application of force to decouple a locking element
from the rest of a locking device has been described, other
decoupling methods may alternatively or additionally be employed.
As an example, a locking element may be decoupled by cutting a
joint between the locking element and the rest of the device using,
for example, a cutter. In some variations, the cutter may be in the
form of a shearing blade that slides to shear the joint between the
locking element and the rest of the device. In certain variations,
a cutter that cuts the connection between a locking element and the
rest of a locking device may also be used to cut a tether being
secured by the locking device. For example, the cutter may cut both
the tether and the joint in a combined manner, thus completely
releasing the locking element with the tether severed.
[0153] It should be understood that any of the methods and device
components described here for actuating a locking device (e.g.,
threading a tether through the locking device, advancing a plug
into a locking member of the locking device, etc.) and/or
decoupling one or more components of the locking device from the
rest of the locking device may be employed with any of the other
locking devices described here, if suitable to do so.
[0154] While certain methods and devices have been described above,
other methods and/or devices may be used to couple and/or decouple
a locking element or locking member and another portion of a
locking device. For example, FIGS. 3A-3D illustrate a method of
locking a tether using another variation of a locking device
comprising a plug. Referring first to FIG. 3A, a locking device
(300) includes a coupling tube (302) having a distal portion that
is coupled to a locking member (304). As shown, locking member
(304) is in the form of a locking tube having an aperture (305)
configured for passage of a tether therethrough. While a locking
tube is shown, other suitable configurations may be used for a
locking member. Locking member (304) may be formed of, for example,
one or more metals, metal alloys, polymers, and/or polymer
composites. As an example, in some variations, locking member (304)
may be formed of a nylon and bismuth trioxide composite, and may
include a layer comprising one or more PEBAX.RTM. polymers.
[0155] A sheath (306) surrounds coupling tube (302), as well as a
portion of locking member (304). However, in some variations, a
sheath may cover the entirety of a locking member, and may even
extend distally beyond the locking member. Moreover, in certain
variations, a sheath may surround only a portion of a coupling
tube. Sheath (306) helps to couple coupling tube (302) to locking
member (304) by compressing the coupling tube to the locking
member. Additionally, locking member (304) includes a shoulder
(308), and coupling tube (302) is configured to latch onto shoulder
(308) when sheath (306) compresses coupling tube (302) to locking
member (304). As shown, coupling tube (302) comprises a shoulder
(311) that latches to shoulder (308). While shoulders (308) and
(311) are shown as generally angular, in some variations, a locking
member shoulder and/or a coupling tube shoulder may be ramp-shaped,
or may have any other suitable shape. A ramp-shaped coupling tube
shoulder may, for example, provide for relatively easy decoupling
of the coupling tube from the locking member when such decoupling
is desired.
[0156] Locking device (300) is configured such that if sheath (306)
is proximally retracted, locking member (304) is decoupled from
coupling tube (302). However, in certain variations, a sheath may
be proximally retracted, while a coupling tube and locking member
are distally pushed upon, in order to decouple the locking member
from the coupling tube. Alternatively or additionally, the coupling
element and locking tube may be distally pushed upon before and/or
after the sheath is proximally retracted. Any other suitable
methods for decoupling the locking member from the coupling tube
may also be employed.
[0157] As shown in FIG. 3A, a plug (310) is disposed within
coupling tube (302), and has a generally missile-shaped
configuration, although other appropriate configurations (e.g., a
plug having any appropriate geometry, such as a plug in the shape
of a cylinder or a plug having a hexagonal cross-section) may also
be used. The plug may be formed of any appropriate materials, such
as one or more polymers, and may in some variations be relatively
rigid. In other variations, a plug may be relatively flexible. In
certain variations, plug (310) may be formed of a nylon and bismuth
trioxide composite. As shown in FIG. 3A, plug (310) includes a bore
(312) containing a radiopaque marker (314). This may allow for
ready viewing of the plug via X-ray fluoroscopy. A pushing member
(316) is also disposed within coupling tube (302), and may be used
to push plug (310) into locking member (304).
[0158] During use of locking device (300), a tether (not shown) may
be threaded through locking member (304) and coupling tube (302).
Any appropriate method may be used to thread the tether including,
for example, one or more of the methods described below. As an
example, a lasso may be used to capture the distal end of the
tether, and to thread the tether first through aperture (305), and
then through coupling tube (302). In some methods, the locking
device may be advanced along the tether to a desired position. As
shown in FIG. 3B, once the tether has been threaded through locking
member (304) and coupling tube (302), pushing member (316) may be
advanced toward the distal end of the locking device. This
advancement of pushing member (316) pushes plug (310) into locking
member (304), compressing the tether between plug (310) and the
inner walls of locking member (304) (e.g., as a result of an
interference fit between the plug and the locking member). Because
coupling tube (302) engages shoulder (308) of locking member (304),
a resistive force is provided during plug advancement. This
resistive force may help to limit the likelihood of locking member
(304) becoming prematurely decoupled from coupling tube (302), as a
result of the advancement of pushing member (316). A step (318)
(FIG. 3B) at the distal end of the locking member prevents the plug
from exiting the locking member.
[0159] Referring now to FIG. 3C, after plug (310) has been pushed
into locking member (304), sheath (306) is proximally retracted.
Prior to being proximally retracted, sheath (306) compresses
coupling tube (302) to locking member (304), thereby engaging
coupling tube (302) with the shoulder (308) of locking member (304)
and coupling the coupling tube to the locking member. However, once
sheath (306) has been proximally retracted, this compressing force
is no longer present. Coupling tube (302) is configured such that
in the absence of this compressing force, coupling tube (302) no
longer forms a tight fit around locking member (304). Rather, the
removal of the compressing force allows coupling tube (302) to
assume a more relaxed configuration, essentially opening up and
thereby disengaging coupling tube (302) from shoulder (308) of
locking member (304). As a result, coupling tube (302) and locking
member (304) are decoupled from each other. This assumption of a
more relaxed configuration by coupling tube (302) may be enhanced
by the presence of a slit (320) in the distal portion of the
coupling tube, as well as two apertures (322) and (324) along the
slit that provide stress relief. While not shown, in some
variations, a coupling tube may include more than one slit in its
distal portion and/or may include a different number of apertures
(e.g., two, three, four, five, etc.). Moreover, while apertures
(322) and (324) are circular, in certain variations, a coupling
tube may alternatively or additionally include one or more
non-circular (e.g., rectangular, triangular, etc.) apertures.
[0160] Referring finally to FIG. 3D, and as discussed above, the
proximal retraction of sheath (306) causes locking member (304) to
be released from coupling tube (302). Plug (310), which was
previously pushed into locking member (304), is released along with
locking member (304). The locking member and plug, now separated
from the other components of the locking device, remain within the
body, securing the tether, while the other components of the
locking device are removed from the body. In this way, sheath (306)
can function as a safety mechanism, preventing locking member (304)
from being released prematurely, and providing the user with
enhanced control over the release of locking member (304).
[0161] Although only a few of the ways in which a locking member or
locking element may be releasably coupled to a device have been
described, it should be understood that any appropriate coupling
may be used, including snap-fits and other coupling mechanisms
(e.g., threads, etc.). Additionally, the couplings described herein
may be readily scaled in size for use even with applications that
may require very small locking members or locking elements (e.g.,
for use in percutaneous applications and/or surgical applications,
such as microsurgical applications). Locking members or locking
elements that are releasably coupled to devices are described, for
example, in U.S. Patent Application Publication No. US 2008/0172035
A1, and in U.S. patent application Ser. Nos. 12/253,885, filed on
Oct. 17, 2008, and 12/480,568, filed on Jun. 8, 2009, each of which
is hereby incorporated by reference in its entirety.
[0162] Locking devices including plugs and tubular components
having a relatively fixed shape or configuration have been shown.
However, in some variations, a locking device may include a plug
and another component that does not have a relatively fixed shape
or configuration. For example, a locking device may include a plug
and an adjustable sleeve configured to be fitted over the plug to
secure a tether therebetween. As an example, FIG. 4A shows a
locking device (400) comprising a plug (406) and a sleeve (402)
having a lumen (404). Referring to FIG. 4B, sleeve (402) may be
fitted over plug (406) to secure one or more tethers (not shown)
therebetween. For example, sleeve (402) may be stretched over plug
(406). In some variations, sleeve (402) may have a larger inner
diameter when in a compressed state and may be retained in a
compressed state (e.g., in a catheter) to allow the sleeve to
receive the plug and the tether. Once released from its compressed
state (e.g., by an element or feature in the catheter), the inner
diameter would collapse, thereby capturing the tether between the
plug and the sleeve in a tight friction fit.
[0163] Sleeve (402) may be formed of, for example, one or more
elastomeric materials and/or metal alloys (e.g., Nitinol foil).
Alternatively or additionally, plug (406) may be formed of, for
example, one or more polymers, such as nylon, polycarbonate,
polyetheretherketone (PEEK), and/or one or more other polymers
suitable for implantation in a body of a subject. The sleeve may be
configured to fit over a portion of the plug, or to fit over the
entire plug. Additionally, in some variations, multiple sleeves may
be used with a single plug. For example, a first sleeve may be
fitted over a plug to secure a tether therebetween, and then a
second sleeve may be fitted over a second sleeve to secure the same
tether (or a different tether) therebetween.
[0164] In some variations, a sleeve may comprise a wall portion
having one or more apertures sized and shaped for passage of a
tether therethrough. The sleeve may be maintained in a straight or
taut configuration as a tether is routed through the apertures and
a plug is pushed into the sleeve to secure the tether therebetween.
In certain variations, the sleeve may be maintained in a straight
or taut configuration using a sheath (e.g., as described above with
reference to FIGS. 3A-3D).
[0165] Locking device plugs may be configured to be fixedly
positioned within a hollow portion of a locking member, or to be
movably positioned within a hollow portion of a locking member. For
example, in some variations, a locking device may comprise a hollow
locking member and a rotatable plug configured to rotate within the
hollow locking member. As shown in FIGS. 5A-5C, a locking device
(500) comprises a locking tube (502) comprising a wall portion
(504) with two apertures (506) and (508) therethrough. Locking tube
(502) has a lumen (510), within which is disposed a rotatable plug
(512) (shown in FIG. 5C, while FIGS. 5A and 5B depict the locking
device without the rotatable plug). Plug (512) has a protrusion
(514) located between two flat surfaces (513) and (515). In some
variations, protrusion (514) may protrude from flat surfaces (513)
and (515) by a distance of 0.003 inch to 0.005 inch. As shown in
FIG. 5C, plug (512) has a dimension (D1) and a dimension (D2) that
is smaller than dimension (D1). With the exception of the portion
of plug (512) comprising protrusion (514) and flat surfaces (513)
and (515), the remainder of plug (512) is generally cylindrical in
shape. However, any other suitable rotatable plug configurations
may be used. When plug (512) is disposed within lumen (510) and a
tether (516) is threaded through apertures (506) and (508), thereby
crossing the lumen, protrusion (514) contacts the tether.
[0166] Referring now to FIGS. 5D and 5E, plug (512) may, in some
variations, be a separate component from locking tube (502).
Alternatively, a plug may be coupled to a locking member during
manufacturing, or may be integrally formed with the locking member.
As shown in FIGS. 5D and 5E, tether (516) may be threaded through
apertures (506) and (508) in wall portion (504) when the plug is
not yet disposed within the lumen of the locking tube. Of course,
in certain variations, a tether may be threaded through the
apertures during and/or after advancement of the plug into the
locking tube. As shown, the tether crosses the lumen of the locking
tube such that the tether is off-center with respect to the lumen.
However, in some variations, the apertures may be positioned so
that a tether passing through them crosses the center of the
lumen.
[0167] As shown in FIG. 5F, after tether (516) has been threaded
through apertures (506) and (508) in locking tube (502), plug (512)
may be advanced into the lumen of the locking tube (e.g., using a
pushing member), such that protrusion (514) on plug (512) contacts
the tether. Typically, this advancement of the plug into the
locking tube may take place at least partially within a sheath or
other elongated member that may later be withdrawn or otherwise
removed from the plug and the locking tube. When the plug is fitted
into the locking tube such that the protrusion contacts the tether,
the contact between the protrusion and the tether provides friction
that helps to hold the plug and the tether in place with respect to
each other (i.e., minimizing relative motion between the plug and
the tether). FIG. 5G shows plug (512) when it is disposed within
locking tube (502). Referring back to FIG. 5C, which also shows the
plug disposed within the locking tube, plug (512) has an exterior
surface (590) with a contour (as shown, a curvature) alignable with
an interior surface (592) of the locking tube. Referring now to
FIG. 5H, tether (516) may be tensioned, thereby causing the plug to
rotate within the lumen of the locking tube (e.g., in the direction
of arrow A2) because of the contact between the tether and the
protrusion on the plug. The tensioning of the tether will generally
cause the plug to rotate toward the direction in which the tether
is being tensioned. This rotation may, in turn, result in more
contact between the plug and the tether, such that the tether may
become further secured. In some variations, plug (512) may be
rotated by at least about 1.degree. (e.g., at least about
10.degree., at least about 20.degree., at least about 45.degree.,
at least about 90.degree., at least about 135.degree.) and/or at
most about 180.degree. (e.g., at most about 135.degree., at most
about 90.degree., at most about 45.degree., at most about
20.degree., at most about 10.degree.).
[0168] In some variations, a relatively low plug force may be used
to plug locking tube (502) with plug (512). Even though a
relatively low plug force may be used, the resulting lock force may
be relatively high. Thus, in certain variations, a tether may be
locked very securely by applying minimal force to a locking device
that locks the tether.
[0169] Other variations of plugs and/or locking members may also be
used. As an example, FIGS. 5I-5N show different views of another
variation of a locking member configured to receive a plug (e.g., a
rotatable plug) to secure a tether therebetween. FIG. 5I shows a
bottom angled perspective view of the locking member (550), while
FIG. 5J shows a bottom view of locking member (550), FIG. 5K shows
a top angled perspective view of locking member (550), FIG. 5L
shows a top view of locking member (550), FIG. 5M shows a front
view of locking member (550), and FIG. 5N shows a back view of
locking member (550). As most clearly shown in FIGS. 5J and 5L,
locking member (550) has a lumen (552) configured to receive a
plug, as well as two apertures (554) and (556) configured for
passage of a tether (558) therethrough. The configuration of
locking member (550) may, for example, provide for relatively
controlled tether routing through the locking member. This, in
turn, may help to control the way in which locking member (550)
lies against body tissue and/or one or more anchors during use.
[0170] FIGS. 5O and 5P show another variation of a plug that may be
used to secure a tether. In some variations, the plug may be
rotatable (e.g., within a lumen of a locking tube). As shown in
FIGS. 5O and 5P, a plug (570) comprises a body (572) and a
plurality of protrusions (as shown, three protrusions, although a
greater or lesser number of protrusions may also be used) in the
form of a stepped configuration (574) extending from the body. The
radial length for each protrusion (576), (578), and (580) is longer
than the previous protrusion. During use, plug (570) may be fitted
into a lumen (582) of a locking tube (584) (FIG. 5P) or other
locking member (e.g., by advancing the plug into the lumen with a
pushing member). As the plug is rotated, the progressively longer
protrusions may contact a tether crossing the lumen, and may secure
the tether within the lumen. Other configurations may also be used.
For example, in some variations, a rotatable plug may comprise a
gear-shaped portion comprising a plurality of teeth of different
lengths (e.g., with each tooth progressively longer than the
previous tooth).
[0171] In certain variations, a locking device may lock a tether
using one or more methods that are different from those described
above. The method or methods may be used in addition to, or as an
alternative to, tensioning a tether to rotate a rotatable plug and
thereby lock the tether.
[0172] For example, FIGS. 5Q-5X show a variation of a locking
device comprising a rotatable plug, where the locking device uses a
pullwire mechanism to lock a tether. As shown there, a locking
device (585) comprises a generally spherical locking member (586),
a rotatable plug or cam (593) disposed within a lumen (533) of
locking member (586), and a pullwire (589) passing through a
channel (539) in locking member (586) (FIG. 5R). FIGS. 5Q-5S depict
locking device (585) in its unlocked or open position, and FIGS.
5V-5X depict locking device (585) in its locked or closed
position.
[0173] In use, plug (593) may be advanced into lumen (533) of
locking member (586), and a tether (not shown) may be routed
through the locking member when the locking member is in its
unlocked position. It should be noted that in some variations, a
locking device may comprise a locking member and a rotatable plug
that are preassembled. Locking member (586) includes two apertures
(587) and (591) configured for passage of a tether therethrough,
and plug (593) also has a slot (588) configured for passage of a
tether when the locking device is in its unlocked position.
[0174] After a tether has been routed through locking device (585),
pullwire (589) may be actuated (e.g., by pulling on the pullwire)
to transition locking device (585) into its locked position. Plug
(593) includes a notch (531) (FIG. 5U) configured to interface with
a notch (597) (FIGS. 5R, 5S, and 5W) on pullwire (589). More
specifically, when pullwire (589) is actuated, notch (597) on
pullwire (589) engages notch (531) on plug (593), thereby causing
plug (593) to rotate. The rotation of the plug helps to secure the
tether. Additionally, plug (593) includes steps (599) configured to
engage the tether as the plug is rotated, thereby helping to lock
the tether in place. Other suitable devices and methods for locking
a tether using a rotatable plug may also be employed, as
appropriate.
[0175] As discussed above, in certain variations, a locking device
may comprise a plug having one or more grooves, apertures, etc.
configured for passage of a tether therethrough. As an example,
FIG. 6 shows a locking device (600) comprising a tubular member
(602) having a wall portion (604) and a lumen (606), and a plug
(608) configured to fit within the lumen of the tubular member. As
shown, wall portion (604) has two apertures (610) and (612)
therethrough, and plug (608) itself also has a channel (614)
extending through its body (616). A tether (618) is routed through
aperture (610) of wall portion (604), as well as through channel
(614) of plug (608). When the plug is further advanced into the
lumen of the tubular member (e.g., by pushing on the plug with a
pushing member), it secures the tether between the body of the plug
and the wall portion of the tubular member. The routing of the
tether through a hole in the wall portion, as well as through a
channel in the plug body, may help to further secure the
tether.
[0176] Plugs may comprise any of a number of different features
suitable for routing of a tether around, through, and/or against
the features. As an example, FIG. 7 shows a locking device (700)
comprising a plug (702) and a tubular member (704) configured to
receive the plug within a lumen (706) of the tubular member. Plug
(702) is somewhat barbell-shaped, such that it has two larger
portions (708) and (710) separated by a smaller neck portion (712).
Tubular member (704) comprises a wall portion (714) having four
apertures (716), (718), (720), and (722) in it. As shown in FIG. 7,
a tether (724) may be routed through apertures (716), (718), (720),
and (722), passing between the larger portions of the plug, and
against smaller neck portion (712). As the plug is further fitted
into the lumen of the tubular member, the tether may become secured
between the plug body and the wall portion of the tubular member.
Additionally, the routing of the tether along the smaller neck
portion of the plug may further help to trap the tether between the
two larger portions of the plug. While not shown, in some
variations, plug (702) may have one or more apertures (e.g.,
channels, etc.) therethrough, and the tether may also be passed
through one or more of those apertures.
[0177] FIG. 8 shows an additional variation of a locking device
comprising a plug. As shown there, a locking device (800) comprises
a tubular member (802) and a plug (804) configured to fit within a
lumen (806) of the tubular member. Tubular member (802) comprises a
wall portion (808) having four apertures (810), (812), (814), and
(816) therethrough, and plug (804) comprises a body (818) including
a grooved neck portion (820). As shown, a tether (822) may be
routed through apertures (810), (812), (814), and (816), and within
grooved neck portion (820). While one tether routing configuration
is depicted, any appropriate tether routing configuration may be
used.
[0178] FIGS. 9A and 9B show another variation of a locking device
(900) and a tether (902) routed through the locking device in a
particular routing configuration. As shown in FIG. 9A, locking
device (900) comprises a tubular member (904) and a plug (906).
Plug (906) comprises a body (908) having a channel (910)
therethrough. Tubular member (904) has a wall portion (912) with
four apertures (914), (916), (918), and (920) therethrough. Tether
(902) is routed through the apertures in the wall portion and
through the channel in the body of the plug. As shown in FIG. 9B,
as the plug is advanced into the tubular member, the tether becomes
secured between the body of the plug and the wall portion of the
tubular member. The additional routing of the tether through the
channel in the body of the plug may, for example, enhance the
securing of the tether within the locking device.
[0179] While a plug having one channel therethrough has been shown,
plugs may have any suitable number and combination of apertures
(e.g., holes, channels), grooves, etc. For example, FIG. 10 shows a
locking device (1000) comprising a tubular member (1002) having a
lumen (1003), and a plug (1004) configured to fit within the lumen
of the tubular member. Plug (1004) has a body (1006) and two
channels (1008) and (1010) through body (1006). A tether (1012) has
been routed into the lumen of the tubular member, past channel
(1010), and through channel (1008). The tether has then been routed
through channel (1010), and back out of the lumen of the tubular
member. This looped routing configuration may provide an especially
secure tether lock (e.g., by providing a relatively long section of
the tether that is in engagement with the plug). Tethers may be
routed through apertures, grooves, etc. in a plug while the plug is
not disposed within a locking member, and/or while the plug is
disposed within a locking member.
[0180] FIG. 11 shows a locking device (1100) similar to device
(1000), but having a tether routed therethrough in a different
routing configuration. As shown there, locking device (1100)
comprises a tubular member (1102) having a lumen (1104), and a plug
(1106) comprising a body (1108) with two channels (1110) and (1112)
formed therein. A tether (1114) has been routed into lumen (1104),
through channel (1112), back out into lumen (1104), through channel
(1110), and out into lumen (1104), eventually exiting the tubular
member. The tether routing configurations that have been shown are
only exemplary, and other tether routing configurations may also be
used, as described in further detail below. Moreover, in some
variations, a tether that has been routed through a device may not
be routed through one or more apertures, etc. in one or more
components of the device. The number of apertures or other features
through which a tether is routed may depend, for example, on the
desired length of the procedure and/or the desired degree of the
security of the tether.
[0181] FIG. 12 depicts yet another routing configuration, although
the routing configuration shown in FIG. 12 is of a tether through a
locking tube disposed within a removable outer sheath. As shown in
FIG. 12, a locking device (1200) comprises a sheath (1202), a
locking tube (1204) comprising a wall portion (1206) having two
apertures (1208) and (1210) and defining a lumen (1212), and a plug
(not shown) configured to fit within the lumen of the locking tube
to secure a tether against the wall portion of the locking tube. In
FIG. 12, locking tube (1204) is disposed within sheath (1202). A
tether (1214) has been routed through the lumen of the locking
tube, as well as through the two apertures in the wall portion of
the locking tube. While one particular routing configuration is
shown, other appropriate routing configurations may also be
used.
[0182] Locking tubes, plugs, and other locking device components
may have any appropriate size, shape, and/or configuration. For
example, FIG. 13 shows a locking device (1300) comprising a plug
(1302) having a body (1304) and a channel (1306) through the body.
Locking device (1300) also comprises a locking member (1308)
including a wall portion (1310) and having a lumen (1312)
configured to receive the plug. Locking member (1308) has a closed
rounded end (1314) that may be an atraumatic tip with respect to
tissue and/or other devices. Additionally, plug (1302) has a
rounded end (1316) that may aid in guiding the plug into an opening
(1318) in the locking member. In use, a tether (not shown) may be
routed through channel (1306), and plug (1302) may be advanced into
locking member (1308) to secure the tether. The proximal end (1322)
of plug (1302) helps to secure the plug and prevent it from backing
out of the locking member by forming a snap-fit with a lip (1320)
at the inner diameter of opening (1318).
[0183] FIG. 14 shows a locking device (1400) comprising a plug
(1402) and a locking member (1404). Locking member (1404) comprises
a wall portion (1406) defining a lumen (1408) and having two
apertures (1410) and (1412) for routing of a tether therethrough.
Plug (1402) comprises a body (1414) having a channel (1416)
therethrough. Plug (1402) has protruding end portions (1418) and
(1420) (e.g., in the form of flanges) which can, for example,
engage with end portions (1422) and (1424) on locking member
(1404). During use, plug (1402) may be advanced further into
locking member (1404) (e.g., using a pushing member), and a tether
(not shown) may be routed through apertures (1410) and (1412)
and/or channel (1416). In some cases, the plug may then be
partially withdrawn out of the locking member, thereby converting
the linear path of the tether to a convoluted path, which may
further secure the tether between the plug and the locking member.
The plug may be partially withdrawn out of the locking member
using, for example, a clamping member that clamps onto the plug and
that is pulled proximally to withdraw the plug.
[0184] In some variations, plug (1402) and locking member (1404)
may be preassembled to avoid having loose parts. In other words,
the plug and the locking member may be preassembled as a single
unit having components that can slide with respect to each other,
via engagement between protruding end portion (1418) on plug (1402)
and corresponding snap-fit end portions (1422) and (1424) on
locking member (1404). In certain variations, a ratcheting feature
or additional snap-fits may be implemented to ensure that the plug
and the locking member are secured in the final configuration.
[0185] Additional variations of methods that include routing a
tether through an aperture in a plug may be employed. As an
example, in some variations, a tether may be routed through a lumen
or channel within a body of a plug, and a sheath or sleeve may then
be pushed over the plug to compress the tether, thereby securing
the tether.
[0186] Other locking member configurations may also be used. For
example, FIG. 15 shows a locking tube (1500) comprising a wall
portion (1502) having two apertures (1504) and (1506) therethrough.
Locking tube (1500) has a lumen (1508) configured to receive a plug
for securing a tether. As shown, lumen (1508) has a first diameter
(D3) and a second diameter (D4) that is larger than the first
diameter. A plug that is designed to fit within lumen (1508) may
have a corresponding shape (i.e., a smaller diameter portion and a
larger diameter portion), or may have a different shape. As an
example, the plug may have one uniform cross-sectional diameter,
but may be compressible such that the plug may be compressed to at
least partially fit within the smaller diameter portion of the
lumen. In some variations, the plug may not have a circular
cross-section. For example, the plug may have an oval cross-section
or an irregular cross-section. Moreover, in certain variations, the
plug may not have rounded edges. For example, the plug may have a
polygonal cross-section, such as a hexagonal cross-section, along
its entire length.
[0187] FIGS. 16A and 16B show a locking device (1600) comprising a
semi-tubular locking member (1602) and a plug (1604) that is
configured to be fitted into the semi-tubular locking member. Plug
(1604) includes a groove (1606) configured for routing of a tether
therethrough. For example, and as shown in FIG. 16B, a tether
(1620) may be routed through apertures (1608), (1610), (1612), and
(1614) in locking member (1602), as well as through groove (1606).
The tether may be locked by advancing the plug into the
semi-tubular locking member.
[0188] During the initial advancement of plug (1604) into
semi-tubular locking member (1602), groove (1606) aligns with
apertures (1608) and (1612), and the tip (1616) of plug (1604)
aligns with apertures (1610) and (1614). At this time, plug (1604)
may be prevented from being loose within the body of the subject
(i.e., the plug may be secured within locking member (1602)). At
the same time, tether (1620) is allowed to move freely within the
locking device because there is sufficient room for the tether to
be pulled through the space between plug (1604) and locking member
(1602) and through apertures (1608), (1610), (1612), and (1614).
The tether fills the circumferential space formed between groove
(1606) and locking member (1602) sufficiently to still allow tether
movement while not allowing the plug to disengage from the locking
member. To lock tether (1620), the plug may be further advanced
into the semi-tubular locking member. While a semi-tubular locking
member is shown, in certain variations, a plug may engage with a
tubular locking member (as shown above, for example), or a locking
member having any other appropriate shape or configuration.
[0189] As described above, in some cases, a locking device may
comprise at least two components that engage with each other by
forming a snap-fit to lock a tether. As an example, FIGS. 17A-17G
show a locking device (1700) including a locking tube (1704) and a
plug (1702) that forms a snap-fit into the locking tube. More
specifically, plug (1702) includes a snap-fit feature (1706) that
engages with a corresponding feature (1708) on locking tube (1704).
Snap-fit feature (1706) comprises a cantilever arm (1710) and a
protrusion (1712) on the cantilever arm. The cantilever arm is
compressed as the plug is fit into locking tube (1704), and then
snaps back into place once placed in the locking tube (i.e.,
protrusion (1712) engages with feature (1708) on the locking tube).
Locking tube (1704) comprises a wall portion (1714) having four
apertures (1716), (1718), (1720), and (1722) therethrough (FIG.
17G). As described above with respect to FIGS. 16A and 16B, plug
(1702) is constrained from coming loose from locking tube (1704).
During use of locking device (1700), a tether (not shown) may be
routed through one or more of the apertures, such that the tether
enters a lumen (1724) (FIG. 17G) of locking tube (1704). The tether
may then be secured between the plug and the wall portion of the
locking tube when the plug is snap-fit into the locking tube.
[0190] FIGS. 18A and 18B show another variation of a locking device
(1800) comprising a plug (1802) that forms a snap-fit with a
locking tube (1804). Plug (1802) has a somewhat different
configuration and shape from plug (1702) of FIGS. 17A-17G. However,
plug (1802), like plug (1702), also comprises a cantilever arm
(1806) and a protrusion (1808) on the cantilever arm that is
configured to snap-fit into a corresponding feature (1810) on
locking tube (1804). Plug (1802) further comprises two regions
(1820) and (1822) that may be used for tether routing. Plug (1802)
may be advanced into locking tube (1804) using, for example, any
suitable device that provides an axial force to plug (1802) while
providing a counteracting force to locking tube (1804).
[0191] FIGS. 19A-19E show a locking device (1900) comprising a plug
(1902) and a locking tube (1904) configured to receive the plug.
The plug has a protrusion (1906) on its distal portion (1908) that
is configured to form a snap-fit with a corresponding feature
(1910) on locking tube (1904) (e.g., when the plug is pushed into
the locking tube). Plug (1902) also comprises tether-routing
regions (1920) and (1922). These tether-routing regions may be
used, for example, to position one or more tethers for locking by
locking device (1900).
[0192] While certain variations of snap-fitting plugs have been
shown and described, other suitable configurations may also be
used. Additionally, other suitable configurations of locking
devices in general may be used.
[0193] For example, different types of locking tubes may be used in
tether-locking devices. Locking tubes may have any suitable number
of apertures along the locking tube body. Moreover, the apertures
may be in any appropriate location, including but not limited to
being located within a wall portion of the locking tube body,
and/or on either end or both ends of the locking tube body. The
apertures may be sized and shaped for the passage of one or more
tethers therethrough. The location, size, and number of apertures
in a locking tube may vary depending, for example, on the size of
the tether to be threaded through, the anticipated level of tension
that may be sustained by the tether, the geometry of the
corresponding plug, and other related factors. In some variations,
the location, size, and number of apertures may be selected to
withstand the forces that may result from tensioning the tether
(e.g., pressure, tensional, shear), so that the locking tube is
unlikely to collapse under stress.
[0194] FIGS. 20A-20H depict different variations of locking tubes
that are configured to receive a plug. FIGS. 20A and 20B depict a
locking tube (2001) that may, for example, secure a plug by
friction fit only, or by both friction fit and snap-fit. Locking
tube (2001) comprises a shoulder (2004) that may be used, for
example, to help temporarily couple the locking tube to one or more
other components of a locking device. Locking tube (2001) also has
two offset apertures (2002) and (2003) in a wall portion of the
tube, along the tube body, as well as an aperture (2005) located at
its distal end. All of the apertures are in fluid communication
with a lumen (2006) of locking tube (2001). Apertures (2002),
(2003), and/or (2005) may have the same or different diameters. In
some variations, one or more of the apertures may have a diameter
of about 0.01 inch to about 0.07 inch, for example, about 0.015
inch to about 0.06 inch, or about 0.04 inch. For example, apertures
(2002) and (2003) may have a diameter of about 0.04 inch, and/or
aperture (2005) may have a diameter of about 0.032 inch. Other
appropriate diameters or other dimensions may also be used. The
length L.sub.1 of locking tube (2001) may be from about 0.2 inch to
0.4 inch, for example, 0.264 inch. Apertures such as apertures
(2002), (2003), and (2005) may be formed at the same time the tube
body is formed, or may be formed after tube body formation.
[0195] FIGS. 20C and 20D depict another variation of a locking tube
(2010). As shown there, locking tube (2010) comprises offset
apertures (2012) and (2013), as well as pairs of apertures (i.e.,
apertures (2017a) and (2017b), and apertures (2018a) and (2018b))
that are aligned with each other. Locking tube (2010) also has an
aperture (2090) located at its distal end. In some variations, one
or more of the apertures may have a diameter of about 0.01 inch to
about 0.07 inch, for example, about 0.015 inch to about 0.06 inch,
or about 0.04 inch. For example, apertures (2017a) and (2017b), and
apertures (2018a) and (2018b) may be about 0.028 inch, and/or
aperture (2090) may be about 0.032 inch. One or more of the
apertures may be in fluid communication with a lumen (2016) of
locking tube (2010). In some variations, offset apertures (2012)
and (2013) may be molded into locking tube (2010), and/or apertures
(2017a), (2017b), (2018a), and (2018b) may be formed after the tube
body has been formed (e.g., by drilling in the tube body).
Apertures may have any appropriate diameter, such as 0.028 inch.
Referring again to FIGS. 20C and 20D, apertures (2017a) and (2017b)
are directly across from each other (i.e., aligned), and apertures
(2018a) and (2018b) are also directly across from each other (i.e.,
aligned). These apertures may be located a certain distance from a
center line indicated by line 20D-20D (i.e., along the longitudinal
axis of a locking tube), such as 0.01 inch away from the center
line. Additionally, apertures (2017a) and (2017b) are located at a
distance (d.sub.1) apart from apertures (2018a) and (2018b), where
(d.sub.1) may be, for example, 0.085 inch. The length L.sub.2 of
locking tube (2010) may be from about 0.2 inch to 0.4 inch, for
example, 0.264 inch.
[0196] Other variations of locking tubes may include apertures in
other locations, which may be aligned in different configurations.
For example, FIGS. 20E and 20F show a locking tube (2020) including
aligned apertures (2027a) and (2027b), as well as aligned apertures
(2028a) and (2028b). Locking tube (2010) also includes offset
apertures (2022) and (2023). The pairs of aligned apertures are
closer to each other than the apertures shown in FIGS. 20C and 20D.
As shown here, the pairs of aligned apertures are separated by a
distance (d.sub.2), where (d.sub.2) may be, for example, 0.06 inch.
Distance (d.sub.2) may be chosen, for example, according to the
expected pressure on the locking tube during routine use (e.g.,
when a tether threaded therethrough is tensioned). Distance
(d.sub.2) may be any appropriate distance, such as from 0.06 inch
to 0.085 inch, or greater than 0.085 inch (e.g., if a large
pressure is expected when a tether threaded therethrough is
tensioned). Locking tube (2020) also has an aperture (2092) located
at its distal end. In some variations, one or more of the apertures
may have a diameter of about 0.01 inch to about 0.07 inch (e.g.,
about 0.015 inch to about 0.06 inch, or about 0.04 inch). For
example, apertures (2027a), (2027b), (2028a) and/or (2028b) may be
about 0.026 inch, apertures (2022) and/or (2023) may be about 0.04
inch, and/or aperture (2092) may be about 0.032 inch. Alternatively
or additionally, in certain variations the length L.sub.3 of
locking tube (2020) may be from about 0.2 inch to 0.4 inch, for
example, 0.264 inch.
[0197] FIGS. 20G and 20H depict another variation of a locking tube
(2030), in which an aperture (2037) is aligned with offset
apertures (2032) and (2033). Locking tube (2030) also has an
aperture (2094) located at its distal end. In some variations, one
or more of the apertures may have a diameter of about 0.01 inch to
about 0.07 inch (e.g., about 0.015 inch to about 0.06 inch, or
about 0.04 inch). For example, apertures (2032) and (2033) may be
about 0.04 inch, aperture (2037) may be about 0.028 inch, and
aperture (2094) may be about 0.032 inch. Alternatively or
additionally, in certain variations, the length of locking tube
L.sub.4 (2030) may be from about 0.2 inch to 0.4 inch, for example,
0.264 inch.
[0198] The characteristics of a locking tube's apertures, such as
their diameters, relative locations, and/or methods of formation,
may be modified as desired (e.g., to ensure that the locking tube
is able to sustain the pressure of a particular tensioned tether
during use). While certain variations of locking tubes have been
shown and described, other suitable configurations may also be
used.
[0199] In some variations, a locking device plug may comprise one
or more one-way features that help to engage the plug with one or
more other locking device components. As an example, FIG. 21A shows
a locking device (2100) comprising a plug (2102) and a locking tube
(2104) configured to receive the plug within a lumen (2106). Plug
(2102) comprises a body (2108) and a locking portion (2110) at the
distal end of body (2108). Locking portion (2110) comprises an
elongated member (2112) having a bulbous tip (2114). When plug
(2102) is pushed into lumen (2106), bulbous tip (2114) passes
through an engagement feature (2116) within lumen (2106). Because
of its shape, bulbous tip (2114) is not able to disengage from the
engagement feature. Thus, plug (2102) may be coupled to locking
tube (2104) (e.g., prior to or in conjunction with tether locking).
Other variations of plugs having such one-way features may be used.
For example, FIG. 21B shows a locking device (2150) comprising a
locking tube (2152) and a plug (2154). Locking tube (2152) has a
lumen (2156) and an inner rim (2158). Plug (2154) has a bulbous
head (2160) that is configured to pass through inner rim (2158)
when the plug is advanced into the locking tube, thereby engaging
the plug with the locking tube. Once this engagement occurs, the
bulbous head functions as a one-way feature, such that the plug
generally will not move in the proximal direction and disengage
from the locking tube.
[0200] Other plug and locking member configurations are possible.
As an example, FIG. 22 shows a locking device (2200) comprising a
locking tube (2202) having a rim (2204) and a lumen (2206) defined
by a wall portion (2208). Locking device (2200) further comprises a
plug (2210) configured to fit within the lumen of the locking tube.
Plug (2210) comprises engagement portions (2214) and (2216), and a
pointed head (2212). The engagement portions function as one-way
features that engage with rim (2204) when plug (2210) is advanced
into lumen (2206). Plug (2210) may be advanced just far enough to
cause engagement portion (2214) to engage with rim (2204), or may
be advanced further to cause engagement portion (2216) to engage
with rim (2204).
[0201] As another example, FIG. 23 shows a locking device (2300)
comprising a locking tube (2302) having a wall portion (2304)
defining a lumen (2306) and including an annular groove (2308) on
its interior surface (2310). Locking device (2300) further
comprises a plug (2312) comprising a body (2314) and a rim (2316)
around the body. When plug (2312) is advanced into lumen (2306) of
locking tube (2302), rim (2316) engages with annular groove (2308),
thereby securing the plug to the locking tube. Similarly, FIG. 24
shows a locking device (2400) comprising a plug (2402) and a
locking tube (2404) configured to receive the plug within a lumen
(2406). Plug (2402) comprises a body (2408) having annular
protrusions (2410) and (2412) at each of its ends. Locking tube
(2404) has an interior surface (2414) including a groove (2416)
configured to form a snap-fit with annular protrusion (2410) or
(2412), thereby coupling the plug to the locking tube (and, e.g.,
securing a tether therebetween).
[0202] As noted above, locking device plugs may have any suitable
size, shape, and/or configuration. For example, FIG. 25 shows a
locking device (2500) comprising a locking member (2502) having a
hollow portion (2504), and a plug (2506) configured to at least
partially fit within the hollow portion of the locking member. Plug
(2506) comprises two flexible legs (2508) and (2510) capable of
being compressed toward each other (e.g., as the plug is being
fitted into the hollow portion of the locking member). Plug (2506)
also comprises ridges (2512) and (2514) on its back surface (2515),
as well as ridges (2580) and (2582). The ridges are configured to
engage with corresponding grooves (2516) and (2518) on an interior
surface (2519) of locking member (2502) as the plug is being
advanced into the locking member. Initially, ridges (2580) and
(2582) engage groove (2518) to secure the plug to the locking
member (thereby preventing the plug from being loose in the body).
Then, as the plug is advanced, ridge (2512) engages groove (2518)
and ridge (2514) engages groove (2516). Thus, plug (2506) may form
a secure fit with locking member (2502), and may thereby securely
lock a tether therebetween.
[0203] Locking member (2502) comprises a wall portion (2520) having
an aperture (2522) therethrough suitable for passage of such a
tether. Wall portion (2520) also comprises an aperture (2560) at
the distal end (2562) of locking member (2502). In certain
variations, aperture (2560) may be sized and shaped for routing of
a tether therethrough. In some cases, locking device (2500) may be
pre-assembled, such that plug (2506) is coupled to locking member
(2502) prior to use. During use, the plug may, for example, be
further advanced into the locking member to secure a tether. The
pre-assembling of the plug and the locking member may, for example,
prevent the plug from becoming displaced from the target site when
the locking device is in use.
[0204] Additional different configurations of plugs are shown in
FIGS. 26A-29B. As shown in FIGS. 26A and 26B, a plug (2600) has a
generally cylindrical shape with a rounded end (2602). The rounded
end may be the distal end of the plug or, in some variations, may
be the proximal end of the plug. FIGS. 27A and 27B show another
variation of a plug (2700). As shown there, plug (2700) is
generally arrow-shaped in side view (FIG. 27A), and comprises an
elongated portion (2702) and a pointed head portion (2704). FIGS.
28A and 28B depict a plug (2800) that is mushroom-shaped, with an
elongated portion (2802) and a bulbous head (2804). Finally, FIGS.
29A and 29B show a plug (2900) comprising an elongated portion
(2902) and a head portion (2904) having a pointed tip (2906) and
multiple one-way features (2908), (2910), and (2912). Plug (2900)
may be formed by, for example, cutting into the exterior surface of
a polyethylene tube and thereby causing strips to peel up from the
exterior surface of the tube (e.g., skiving the tube). The one-way
features may, for example, allow the plug to be translated in one
direction within a hollow portion (e.g., a lumen) of a locking
member, while not allowing the plug to be translated in another
direction (e.g., the opposite direction) within the hollow portion
of the locking member.
[0205] The head portions of the plugs shown in FIGS. 27A, 27B, 28A
and 28B may serve a similar function. For example, they may be
compressible, such that they may be squeezed into a hollow portion
of a locking member. However, once within the hollow portion, they
may return to their original size and shape, which may prevent them
from moving back out of the hollow portion. As a result, the plugs
may form a relatively secure coupling with a locking member.
[0206] While certain plug configurations have been shown, others
are possible. For example, in some variations, a plug may have a
pointed tip that is off-center with respect to a longitudinal axis
of the plug. The off-center location of the tip may, for example,
help prevent the plug from inadvertently spearing a tether crossing
the center of a locking tube lumen.
[0207] Plugs may be formed of any suitable material, and in some
cases, a plug may be formed of a swellable and/or otherwise
expandable material. For example, a plug may be formed of a
hydrogel that absorbs water over time to provide enhanced locking.
In some variations, a nylon plug may be employed (e.g., with a
Nitinol locking tube).
[0208] In certain variations, a plug may comprise one or more
anchor portions. The anchor portions may, for example, help to
anchor the plug to body tissue during use. As an example, the plug
may be used to lock a tether that is coupled to multiple anchors.
The anchors may be embedded in tissue, and the anchor portion of
the plug may also be embedded in tissue. This may, for example,
limit the likelihood of the plug becoming displaced from the target
site and traveling to a non-target area. As an example, FIG. 30A
shows a plug (3000) comprising a body portion (3002) and an anchor
portion (3004) extending from the body portion. Anchor portion
(3004) may, for example, be molded into body portion (3002) or
embedded in body portion (3002). Anchor portion (3004) comprises
two hooked portions (3006) and (3008) extending in opposite
directions. The hooked portions may, for example, have sharp tips
suitable for engaging tissue. As shown in FIG. 30B, during use,
plug (3000) may be advanced into a lumen (3010) of a locking member
(3012) (e.g., to secure a tether between the body portion of the
plug and a wall portion (3014) of the locking member). As shown in
FIG. 30C, the plug may then be further advanced, such that a distal
portion (3016) of the plug (including anchor portion (3004)) exits
the lumen of the locking member. Anchor portion (3004) may then
engage tissue (3018). Referring back to FIG. 30B, hooked portions
(3006) and (3008) of anchor portion (3004) may be compressible,
such that they may be compressed within a hollow portion of a
locking member during advancement of the plug into the hollow
portion. In certain variations, one or more rings (not shown) may
be advanced over locking member (3012) to further secure the
locking member to the plug.
[0209] In some variations, a tether may comprise one or more
features that help the tether to engage body tissue. For example.
FIG. 31A shows a tether (3100) having a coil (3102) extending from
a central region (3106) of the tether. The coil may engage tissue
at a target site, thereby helping to secure the tether to the
target site. Any number of coils or other engagement mechanisms or
combinations thereof may be used. Non-limiting examples of other
engagement mechanisms or features that may be used on a tether
include bumps, ridges, etc. Additionally, the coils and/or other
engagement mechanisms may be located at any suitable position along
the tether. For example, FIG. 31B shows a tether (3110) having a
coil (3112) extending from its distal end (3114). Of course, one or
more other locking device components may alternatively or
additionally include one or more coils and/or other engagement
mechanisms. For example, FIG. 32 shows a locking device (3200)
comprising a plug (3202) and a locking tube (3204) having a lumen
(3206) configured to receive the plug. Plug (3202) comprises a coil
(3208) at its distal end (3210). As shown in FIG. 32, the coil may
engage a tether (3212) threaded through two apertures (3214) and
(3216) in a wall portion (3218) of the locking tube. Thus, the coil
may help to further lock the tether within the locking device.
[0210] In certain variations, a plug may comprise two or more
portions that are capable of being closed toward each other to
engage one or more tethers therebetween. For example, FIGS. 33A and
33B show a plug (3300), with FIG. 33B being a cross-sectional view
of the plug taken along line 33B-33B in FIG. 33A. Plug (3300)
comprises two portions (3302) and (3304) that are connected to each
other by a hinge (3306). While a hinge has been shown, other
suitable connection mechanisms may alternatively or additionally be
used. Portion (3302) has an interior surface (3308), and portion
(3304) has an interior surface (3310). In use, one or more tethers
(not shown) may be routed between surfaces (3308) and (3310) (e.g.,
contacting one or both of the surfaces). Then, portion (3302) may
be folded toward portion (3304) around hinge (3306) so that
interior surface (3308) contacts interior surface (3310). The
tether or tethers may be trapped between the two portions when they
are folded toward each other. In some variations, the plug may then
be advanced into a locking member or another device component
(e.g., to secure the tether).
[0211] In certain variations, one or more of the portions may have
a modified surface and/or one or more other features that help to
maintain the coupling between the portions. For example, FIGS. 33C
and 33D show a plug (3320), with FIG. 33D being a cross-sectional
view of the plug taken along line 33D-33D in FIG. 33C. Plug (3320)
has a first portion (3322) with an interior surface (3324) and a
second portion (3326) with an interior surface (3328). The interior
surfaces are textured to provide enhanced engagement between the
interior surfaces when the two portions are folded toward each
other around a hinge (3330). Other suitable engagement mechanisms
may be used. As an example, FIG. 33E shows a plug (3350) comprising
a first portion (3352) having an interior surface (3354) and a
second portion (3356) having an interior surface (3358). The first
and second portions may be folded toward each other around a hinge
(3360), so that the surfaces contact each other and couple to each
other, thereby entrapping one or more tethers (not shown)
therebetween. Interior surface (3354) comprises holes (3362),
(3364), (3366), (3368), and (3370), and interior surface (3358)
comprises corresponding protrusions (3372), (3374), (3376), (3378),
and (3380) sized to snap into the holes on interior surface (3354),
thereby helping to secure second portion (3356) to first portion
(3352).
[0212] While the first and second portions of the plugs shown in
FIGS. 33A-33E are minor images of each other, in some variations, a
plug may comprise two or more portions that are not minor images of
each other. Moreover, the different portions of a plug may have
different sizes.
[0213] In certain variations, a locking device may comprise a plug
and a locking member that are coupled to each other. The locking
member and the plug may be coupled in any of a number of different
ways. As an example, FIG. 34A shows a locking device (3400)
comprising a plug (3402) and a locking member (3404) configured to
receive the plug. The locking member and the plug are coupled to
each other by a coupling member (3406) (as shown, in the form of a
tether, although other suitable coupling members may alternatively
or additionally be used). While one coupling member is shown, in
some variations, a locking member and a plug may be coupled by
multiple coupling members. Coupling member (3406) may be attached
to at least one of plug (3402) and locking member (3404), and/or
may be integral with at least one of plug (3402) and locking member
(3404). Locking device (3400) may be formed using, for example,
injection molding.
[0214] As shown in FIG. 34B, during use, plug (3402) may be fitted
into locking member (3404) (e.g., to secure a tether therebetween).
Should plug (3402) inadvertently become decoupled from locking
member (3404), the coupling between the plug and the locking member
may limit the likelihood of one or both of the components traveling
to a non-target location. For example, the locking member may have
one or more apertures in a wall portion through which a tether is
threaded. If the plug becomes unplugged from the locking member,
the plug may still remain at the target site because it is coupled
to the locking member which, in turn, is coupled to the tether. In
some variations, the coupled plug and locking member may be used in
a procedure in which the plug and locking member are not contained
within a device or device component, such as a catheter. In certain
variations, and as shown in FIG. 34B, coupling member (3406) may be
slidably or fixedly attached to an anchor (3408) which may, in
turn, be affixed to tissue at a target site, thereby helping to
retain locking device (3400) at the target site.
[0215] Locking devices comprising components that are coupled to
each other by at least one coupling member may have any suitable
configuration. For example, FIG. 34C shows a locking device (3420)
comprising a plug (3422), a locking tube (3424) configured to
receive plug (3422) within a lumen (3426), and a coupling member
(3428) coupling plug (3422) to locking tube (3424). Locking tube
(3424) comprises a wall portion (3430) having two apertures (3432)
and (3436) for passage of a tether therethrough. Additionally, plug
(3422) and locking tube (3424) each comprise a tether ring (3438)
and (3440), respectively. A tether (not shown) may be passed
through one or both of these tether rings, and may then be secured
to a target site (e.g., by attaching the tether to tissue at the
target site). This may help to retain locking device (3420) at the
target site. Tether rings are discussed in further detail
below.
[0216] A coupling member may be attached to at least two components
of a locking device at any appropriate location on the components.
For example, FIG. 35A shows a variation of a locking device (3500)
comprising a locking member (3502) coupled to a plug (3504) by a
coupling member (3506). FIG. 35B shows another variation of a
device (3520) comprising a locking member (3522) coupled to a plug
(3524) by a coupling member (3526). FIG. 35C shows an additional
variation of a device (3540) comprising a locking member (3542)
coupled to a plug (3544) by a coupling member (3546). Finally, FIG.
35D shows a variation of a device (3560) comprising a locking
member (3562) coupled to a plug (3564) by a coupling member (3566).
Other coupling member configurations and attachment positions may
also be used.
[0217] FIG. 36 shows an additional variation of a locking device
comprising a plug and a locking member that are coupled to each
other. As shown there, a locking device (3600) comprises a locking
member (3602) having a hollow portion (3604). Locking device (3600)
also comprises a plug (3606) comprising two flexible coupling
portions (3608) and (3610) configured to couple the plug to the
locking member. More specifically, the coupling portions are
configured to flexibly allow plug (3606) to slide into locking
member (3602) (i.e., to advance plug (3606) into hollow portion
(3604) of locking member (3602)). In some variations, locking
device (3600) may be formed by molding hollow portion (3604) and
plug (3606). In certain variations, the hollow portion and the plug
may be molded on two different levels (e.g., so that the hollow
portion may be formed using a mandrel that does not interfere with
formation of the plug). Other configurations may be used. For
example, a plug may be disposed in a sheath, and a tubular member
may be advanced into the sheath to engage the plug.
[0218] Another variation of a locking device (3700) is depicted in
FIG. 37. As shown there, locking device (3700) comprises a
ring-shaped locking member (3702) surrounding a plug member (3704)
comprising an elongated portion (3706) and a plug portion (3708).
Plug portion (3708) is configured to fit within a cut-out (3710) in
ring-shaped locking member (3702) when plug portion (3708) is
advanced toward ring-shaped locking member (3702) and/or
ring-shaped locking member (3702) is advanced toward plug portion
(3708). Ring-shaped locking member (3702) and plug portion (3708)
are configured to secure a tether therebetween.
[0219] In certain variations, one or more components of a locking
device may comprise at least one hook configured to engage one or
more other components of the locking device. For example, FIG. 38
shows a locking device (3800) comprising a locking member (3802)
having a hollow portion (not shown). Locking device (3800) also
comprises a plug (3804) configured to at least partially fit within
the hollow portion of the locking member. Plug (3804) has a hooked
distal region (3806) that hooks onto a rim (3808) on locking member
(3802) when the plug is advanced into the locking member. This
hooked distal region may form a living hinge with the rest of the
plug body that allows the hooked distal region to move to fit
around rim (3808). While a rim is shown, in some variations, a
locking member may include a notch, and the hooked distal region
may couple to the notch. This may, for example, allow the locking
device to maintain a relatively low profile.
[0220] As described above, in certain variations, one or more
components of a locking device may comprise at least one tether
ring configured for passage of a tether therethrough. For example,
FIG. 39A shows a locking member (3900) comprising a body portion
(3902) and a rim (3904), as well as a tether ring (3906) coupled to
or integral with rim (3904). FIG. 39B shows a locking member (3910)
comprising a body portion (3912) and a rim (3914), as well as a
tether ring (3916) coupled to or integral with body portion (3912).
In some variations, a locking component may have multiple (e.g.,
two, three, four, five) tether rings. The tether rings may all be
of the same size, or may have different sizes. For example, FIG.
39C shows a locking member (3920) comprising a body portion (3922)
and a rim (3924), as well as a tether ring (3926) coupled to or
integral with body portion (3922) and two tether rings (3928) and
(3930) coupled to and/or integral with rim (3924). During use, one
or more tethers (not shown) may be threaded through one or more of
the tether rings and, for example, may be secured to tissue (e.g.,
a ventricle wall) at the target site.
[0221] While locking members comprising tether rings have been
shown, other components of locking devices may alternatively or
additionally include one or more tether rings. For example, FIG.
39D shows a locking device (3950) comprising a plug (3952) and a
locking member (3954) configured to receive the plug. Plug (3952)
has a hooked distal region (3956) that hooks onto a rim (3958) on
locking member (3954) when the plug is advanced into the locking
member. Moreover, plug (3952) comprises a tether ring (3960) that
may be used, for example, to secure plug (3952) to body tissue via
a tether. In some variations, a tether ring may be used to help
position one or more components of a locking device in the correct
locking location. For example, a tether may be threaded through a
tether ring on a plug, and the plug may be advanced along the
tether to the target locking site. In certain variations, a locking
device may comprise multiple components having tether rings. As an
example, FIG. 39E shows a locking device (3970) comprising a plug
(3972) and a locking member (3974) configured to receive the plug.
Both the locking member and the plug comprise a tether ring. More
specifically, locking member (3974) comprises a tether ring (3976),
and plug (3972) comprises a tether ring (3978).
[0222] While locking devices comprising plugs and various locking
member configurations have been shown, in some cases, other types
of locking devices may be used to secure one or more tethers. For
example, FIGS. 40A-40C illustrate variations of a locking device
(4000) and a related method. As shown in FIGS. 40A and 40B, locking
device (4000) comprises a tubular member (4002) and a locking
member (4004). In FIGS. 40A and 40B, the locking member is in an
open configuration. Locking member (4004) comprises a first
clamping portion (4006), a second clamping portion (4008), and a
hollow region (4010) therebetween. Hollow region (4010) is
configured to receive at least a portion of tubular member (4002)
when the locking member is in the open configuration. A tether
(4012) is threaded through the tubular member.
[0223] Referring now to FIG. 40C, locking member (4004) can be
changed from an open configuration to a closed configuration by
withdrawing tubular member (4002) from hollow region (4010). As
shown, the tubular member has been withdrawn without also
withdrawing the tether. This may be achieved, for example, by
temporarily holding the tether in place (e.g., with a clamp) while
withdrawing the tubular member over the tether. In the closed
configuration, first clamping portion (4006) clamps against second
clamping portion (4008), thereby securing tether (4012)
therebetween.
[0224] Locking device (4000) may be deployed using, for example, a
catheter comprising an outer sheath, a pushing member, and a
tubular member that is a slidable element within a lumen of the
pushing member. The locking device may initially be constrained
within the catheter. When the tubular member is retracted, the
frictional forces between the tubular member and the locking device
may pull the locking device proximally up against the pushing
member. This may prevent further movement of the locking device,
and the tubular member may slide proximally, thereby causing
locking device (4000) to clamp down on a tether. Subsequently, the
pushing member may be pushed distally to release the locking device
from the catheter.
[0225] While locking member (4004) comprises clamping portions
(4006) and (4008) having a particular configuration, locking
members comprising clamping portions with different configurations
may also be used. For example, FIG. 41 shows a locking device
(4100) comprising a tubular member (4102) and a locking member
(4104) having two clamping portions (4106) and (4108) and a hollow
region (4110) therebetween. In its open configuration (shown in
FIG. 41), locking member (4104) is configured to hold at least a
portion of tubular member (4102) in hollow region (4110). However,
when tubular member (4102) is withdrawn or otherwise removed from
locking member (4104), locking member (4104) assumes its closed
configuration, in which the clamping portions of the locking member
clamp together (e.g., thereby securing a tether (not shown)
therebetween).
[0226] FIGS. 42A-42G show another variation of a locking device
(4200), this variation comprising a collet (4201) and a sleeve
(4203) configured to surround at least a portion of the collet to
clamp a tether within the collet. Collet (4201) and/or sleeve
(4203) may be formed of, for example, one or more metals (e.g.,
titanium), metal alloys (e.g., Nitinol, stainless steel), and/or
one or more polymers (e.g., PEEK). The collet and sleeve may be
formed of the same materials, or different materials. They may be
formed using, for example, conventional machining methods,
electrical discharge machining (EDM), laser cutting, metal
injection molding, and/or phase injection molding. Collet (4201) is
a single-slit design with a proximal feature (4220) that allows for
attachment to the rest of device (4200), as well as a radiused
distal end (4222), and a collet body (4221) therebetween. While a
single-slit configuration is shown, other collet configurations may
also be used, as discussed in further detail below. Sleeve (4203)
comprises a rigid or semi-rigid tube with an internal diameter that
closely matches the outer diameter of collet body (4221). Sleeve
(4203) is coupled to an elongated tubular portion (4204). During
use of locking device (4200), sleeve (4203) may slide over collet
body (4221), thereby forcing the collet body to compress. This may
cause the collet body to secure a tether (4208) routed through slit
(4230).
[0227] Referring to FIG. 42B specifically, the tether may be routed
into the locking device using, for example, a lasso or snare
(described in further detail below). Locking device (4200)
comprises a series of concentric shafts that slide relative to each
other to decouple the collet from the rest of the locking device,
after the collet has been used to lock a tether. A release tube
(4209) provides a lumen for the passage of a tether snare (4207)
and tether (4208). Release tube (4209) may also be used to decouple
collet (4201) from the rest of locking device (4200) by pushing the
collet away from the rest of the locking device.
[0228] During use, tether (4208) is drawn into locking device
(4200) through release tube (4209) using snare (4207). The locking
device is then advanced over tether (4208) until collet (4201)
reaches the desired locking location. At the desired locking
location, tether (4208) may be tensioned to provide a cinching
effect, and sleeve (4203) may be pushed over collet (4201) using a
pushing member (4205). When sleeve (4203) comes into contact with a
stop (4210) on collet (4201), pushing member (4205) retracts to
expose an interlocking collet feature (4206) and the distal end of
a pull tube (4202). Release tube (4209) may then be advanced
distally, causing collet (4201) to decouple from the rest of
locking device (4200).
[0229] A method of using locking device (4200) to lock a tether is
shown more in more detail in FIGS. 42C-42G. First, FIG. 42C shows
locking device (4200), including collet (4201), prior to
deployment. FIG. 42D shows locking device (4200) after deployment,
when sleeve (4203) has slid over collet (4201) and forced the
collet to collapse, thereby securing tether (4208) (FIG. 42B). As
shown in FIG. 42E, push tube (4205) may then be retracted to expose
the distal end of pull tube (4202). Referring to FIG. 42F, release
tube (4209) may then be used to release collet (4201). Finally, and
referring now to FIG. 42G, release tube (4209) may be retracted
after collet (4201) and sleeve (4203) have been released from the
rest of locking device (4200).
[0230] While a certain variation of a collet has been shown and
described, any other suitable variations may be used. As an
example, in some variations, a collet may be releasably coupled to
a locking device by threading on the collet and/or one or more
other components of the locking device. The number of threads on
the collet and/or other component or components may be selected to
minimize the amount of turning required to release the collet, and
may be, for example, one to three threads. In variations in which
threading is used, the collet may be decoupled from the locking
device (e.g., after the collet has been used to lock a tether) by
rotating the locking device to release the collet. In certain
variations, a collet may have a slotted key feature that couples
the collet to the rest of a locking device (e.g., in which a
protrusion on the collet keys into a slot on one of the other
components of the locking device, or vice versa). In some
variations, and referring now to FIG. 43A, a collet (4300) may
include a guide hole (4302) to control placement of a tether inside
the collet. This guide hole may, for example, keep the tether
centered in the collet. In certain variations, and referring now to
FIG. 43B, a collet (4350) may include a clearance cut (4352) that
allows the collet to receive a tether without having to open
particularly wide. The edges of the clearance cut may, for example,
be radiused (e.g., to limit tether abrasion).
[0231] Some variations of locking devices may comprise a collet
deployment mechanism (e.g., the distal portion of locking device
(4200)) comprising one or more relatively rigid components.
Alternatively or additionally, a collet deployment mechanism may
comprise one or more relatively flexible components. A relatively
rigid collet deployment mechanism may, for example, exhibit high
structural integrity, which may be particularly advantageous for
pushing the collet components. In some cases in which a relatively
rigid collet deployment mechanism is used, the collet deployment
components may be relatively short in length. As the length of the
components decreases, the flexibility of the locking device and the
maneuverability of its distal portion may increase.
[0232] One variation of a collet deployment mechanism is shown in
FIG. 44A. As shown there, a locking device (4400) may be used to
deploy a collet (4405) with a sleeve (4406). A tether may be
secured, for example, by trapping it between collet (4405) and
sleeve (4406), and/or within a slit in the collet, with the sleeve
pressing down upon the slit to hold the tether in place. The
proximal end (4403) of collet (4405) may be at least partially
housed in a sheath (4404) of locking device (4400), and may be
sized and shaped to be restrained by an interlocking collet feature
(4401). Interlocking collet feature (4401), in turn is at least
partially enclosed in sheath (4404). Interlocking collet feature
(4401) includes two latches (4407a) and (4407b) that hook to the
proximal end (4403) of collet (4405) and thereby retain the collet.
When it is desired to release collet (4405), interlocking collet
feature (4401) may be proximally withdrawn, drawing collet (4405)
into sleeve (4406) (e.g., thereby securing and locking a tether).
The interlocking collet feature may be further withdrawn in the
proximal direction, so that latches (4407a) and (4407b) are no
longer restrained and therefore separate from each other to release
collet (4405). The combined collet and sleeve may then be deployed
using, for example, a pushing member (not shown) of locking device
(4400). Interlocking collet feature (4401) is also shown in FIG.
44C, where its collet coupling region (4408) is depicted as having
a length (4402). In some variations, length (4402) may be, for
example, from about 0.1 inch to about 0.75 inch.
[0233] Another variation of a collet deployment mechanism is
depicted in FIG. 44B. FIG. 44B shows a locking device (4450)
comprising a collet (4415) and a sleeve (4416). The proximal
portion of collet (4415) has a groove (4413) configured to engage
with an interlocking collet feature (4411) of device (4450).
Interlocking collet feature (4411) is at least partially enclosed
in a sheath (4414). Sheath (4414), as well as any other sheaths
described here, may be formed of, for example, any suitably
flexible material or materials, such as braided polyimide, or any
similar braided material, or the like. Interlocking collet feature
(4411) may retain collet (4415) via a single latch (4417) that fits
into groove (4413).
[0234] Interlocking collet feature (4411) is also shown in FIG.
44D, where its collet coupling region (4418) has a length (4412).
In some cases, interlocking collet feature (4411), with its single
latch (4417), may have a shorter collet coupling region than
interlocking collet feature (4401), with its dual latches (4407a)
and (4407b), as demonstrated by a comparison of length (4412) (FIG.
44D) to length (4402) (FIG. 44C). For example, length (4402) may be
about 0.5 inch, while length (4412) may be about 0.25 inch. This
difference in lengths may result from it being easier to deploy a
collet by withdrawing a sheath over just one latch, in comparison
to deploying a collet by withdrawing a sheath over two or more
latches. As the number of latches in a collet coupling region
increases, the length of the collet coupling region may also
increase, in order to accommodate a greater outward expansion of
the latches that may be required to effect collet release. While
certain variations of interlocking collet features have been
described, other variations of interlocking collet features may
have other suitable configurations for releasably engaging a
collet.
[0235] Other modifications to the collet geometry and/or
interlocking collet feature may be made to reduce the length of the
distal portion of the locking device. For example, some variations
of collets may not have a distal cap (the dome-shaped structure in
FIGS. 44A and 44B).
[0236] Modifications to various collet and/or sheath dimensions may
also be made to adjust the compressive force on a tether threaded
through the collet. As an example, FIG. 44E shows a collet with a
body (4423) restrained by a sheath (4421). Collet body (4423) has a
slit (4425) having a dimension (4424), while collet body (4423) has
a dimension (4422). Additionally, sheath (4421) has an inner
diameter (4420). Modifying inner diameter (4420) of sheath (4421)
with respect to dimension (4422) of collet body (4423) may alter
the compressive force on a tether threaded through slit (4425) of
collet (4423). In some variations, inner diameter (4420) and
dimension (4422) may both be 0.085 inch, or dimension (4422) may be
smaller than inner diameter (4420), which may reduce the
compressive force on the tether. In certain variations, sheath
(4421) may have first and second inner diameters, where the first
inner diameter is a suitable size for receiving a collet, and the
second inner diameter is a suitable size for retaining the collet
with a desired compressive force. In some variations, the sheath
may comprise one or more elastic materials. Modifying slit
dimension (4424) may also alter the compressive force on the
tether. Slit dimension (4424) may have any appropriate value (e.g.,
0.006 inch), where a smaller width may result in a greater
compressive force, while a larger width may result in a lesser
compressive force.
[0237] Other features of the collet may alternatively or
additionally be modified to effect different levels of compressive
force on a tether threaded through the collet via slit (4425).
Moreover, certain modifications may help to secure and lock a
tether within slit (4425) of the collet. For example, a material
with increased surface friction may be used to form the collet, the
surface friction in the slit may be increased, the tether may be
coated or otherwise modified to increase the surface friction on
the tether, and/or the tether may have a relatively large diameter.
Modifications such as these or other appropriate modifications may
be made to the collet, sheath, and/or tether to ensure that the
compressive force of the collet on the tether (or other force(s)
relevant for retaining a tether in the collet) is sufficient to
withstand the forces sustained during use, which may be, for
example, approximately 2 lbs.
[0238] Collets that are used to clamp a tether may have any
appropriate configuration. As shown above, in some variations, a
sleeve may be used to essentially clamp a collet over a tether. For
example, FIGS. 45A-45F depict a device (4500) comprising a collet
(4502) comprising a pronged protrusion (4503) and a lumen (4507)
therethrough. Lumen (4507) may be oriented along a longitudinal
access of collet (4502) as illustrated, or may be oriented in any
other suitable fashion. FIG. 45A depicts lumen (4507) extending
through the entire length of collet (4502), however, in other
variations, a lumen may extend through only a portion of the
collet, and/or a collet may have multiple (e.g., two, three, four,
five) lumens. Locking device (4500) also comprises a sleeve (4504)
including an aperture (4505) sized and shaped to retain pronged
protrusion (4503). As shown in FIGS. 45A and 45C, during use, a
tether (4510) may be routed through aperture (4505) of sleeve
(4504), and through lumen (4507) of collet (4502).
[0239] In some variations, locking device (4500) may also comprise
an elongated tubular member (4506), and both collet (4502) and
sleeve (4504) may be contained within the elongated tubular member,
as shown in FIGS. 45B and 45C. FIGS. 45B and 45C depict a potential
arrangement of collet (4502), sleeve (4504), and elongated tubular
member (4506) prior to the deployment of collet (4502). Referring
now to FIG. 45D, according to one method of deployment, collet
(4502), sleeve (4504), and a rod (4508) may be arranged at least
partially within elongated tubular member (4506). Tether (4510) may
be threaded through sleeve (4504) and collet (4502), such that a
portion of the tether passes through pronged protrusion (4503). The
tether may be tensioned before it is threaded through the sleeve
and collet, and/or may be tensioned after such threading. To secure
tether (4510), rod (4508) may be actuated in the distal direction
to push collet (4502) toward sleeve (4504), thereby engaging
pronged protrusion (4503) with aperture (4505) of sleeve (4504). As
a result, tether (4510) may become clamped, as shown in FIG. 45E.
Pronged protrusion (4503) may be secured within aperture (4505) of
sleeve (4504) by any suitable mechanism. For example, pronged
protrusion (4503) may form a snap-fit or a friction fit with
aperture (4505). As depicted in FIG. 45F, once the resulting
collet-sleeve assembly (4520) has fixedly secured tether (4510),
elongated tubular member (4506) may be withdrawn, and/or
collet-sleeve assembly (4520) may be pushed out of elongated
tubular member (4506) by advancing rod (4508) further distally.
[0240] As shown in FIG. 45G, in some variations, a locking device
comprising a collet may also comprise a collet coupler that may
facilitate the interaction between the collet and a collet sleeve
of the locking device. FIG. 45G shows a locking device (4550)
comprising a collet coupler (4556) (as shown, comprising a
protrusion (4559), although other appropriate configurations may be
used). Collet (4552) comprises curved grooves (4551) shaped to
mechanically interlock with a protrusion (4559) of collet coupler
(4556). Collet coupler (4556) further comprises a slit (4564) and a
spring (4558) that may function to engage protrusion (4559) and
grooves (4551), thereby causing collet (4552) to be retained by the
collet coupler (4556). Spring (4558) may help to engage collet
(4552) onto collet coupler (4556) by applying a force that wedges
protrusion (4559) within curved grooves (4551) (e.g., a
spring-loaded compressive force may retain protrusion (4559) within
curved grooves (4551)).
[0241] During use, a tether (4560) may be threaded through collet
(4552), into collet coupler (4556), and through slit (4564). After
the tether has been threaded through the collet and the collet
coupler, the collet and collet coupler may be slid distally (e.g.,
toward a terminal anchor in a mitral valve repair procedure).
Locking device (4550) also comprises a pushing member (4562) and a
sleeve (4554). Pushing member (4562) may be used to push sleeve
(4554) distally so that collet (4552) is seated in aperture (4555).
In some variations, the diameter of collet (4552) may be slightly
larger than the diameter of aperture (4555), such that when collet
(4552) is retained in sleeve (4554), it is compressed. The
compression of the collet may act to pinch tether (4560) and
thereby secure it in the collet. During and/or after securement of
the tether, pushing member (4562) may be retracted proximally.
Collet (4552) may then be disengaged from collet coupler (4556) by,
for example, compressing spring (4558) while sliding protrusion
(4559) out from curved grooves (4551). This may allow for
controlled and reversible engagement between collet (4552) and
collet coupler (4556). For example, when the spring is compressed,
collet (4552) may be moved with respect to collet coupler (4556)
and when the spring is expanded, collet (4552) may be retained by
collet coupler (4556) via protrusion (4559). While one variation of
a retractable spring system is shown, in some cases, other suitable
variations of retractable spring systems may be used to control the
engagement between collet (4552) and collet coupler (4556).
[0242] While sleeves have been shown and described, in some
variations, a collet may be used to lock a tether without the use
of a sleeve. Such a collet may, for example, be temporarily
expanded to receive a tether, and then allowed to collapse back
onto the tether to lock the tether. As an example, FIGS. 46A and
46B show a locking device (4600) comprising an elongated tubular
member (4606), a mandrel (4604), and a collet (4602). Mandrel
(4604) is disposed within elongated tubular member (4606), and also
is inserted between protrusions (4605) of collet (4602). As shown,
mandrel (4604) may have a longitudinal lumen (4607) therethrough
that is sized and shaped for the passage of a tether. Mandrel may
be generally cylindrical as shown in FIG. 46A (in which the mandrel
actually comprises two cylindrical portions), or may have any other
suitable geometry (e.g., rectangular, triangular, or the like).
[0243] Collet (4602) has an open configuration (FIG. 46A), and a
closed configuration (FIG. 46B). In the open configuration,
protrusions (4605) are not in contact with each other, and tether
(4610) may slide through collet (4602). By contrast, in the closed
configuration, protrusions (4605) contact each other, thereby
locking tether (4610) in place. Any suitable mechanism may be used
to convert collet (4602) from its open configuration to its closed
configuration. According to one mechanism, collet (4602) may be
formed of an elastic or shape-memory material, e.g., nickel
titanium alloys, such as Nitinol, such that collet (4602) has a
relaxed state in which protrusions (4605) fully contact each other
(i.e., a closed configuration), as shown in FIG. 46B. The collet
may be converted to an open configuration, as shown in FIG. 46A, by
wedging mandrel (4604) between protrusions (4605). In the open
configuration, tether (4610) may be slidable through collet (4602).
To secure tether (4610) within collet (4602), mandrel (4604) may be
withdrawn proximally, so that it is no longer located between
protrusions (4605). During such withdrawal, the tether may, for
example, be held in place (e.g., clamped), so that it is not also
withdrawn. As depicted in FIG. 46B, in the absence of the mandrel,
the protrusions (4605) may close so that they contact each other
and thereby clamp tether (4610).
[0244] FIGS. 46C and 46D each show additional variations of
sleeveless collets (4650) and (4680), respectively. Sleeveless
collet (4650) has a horizontal slot (4654) and a vertical slot
(4656) sized and shaped for the passage of a tether (4652)
therethrough, and sleeveless collet (4680) has a horizontal slot
(4684) sized and shaped for the passage of a tether (4682)
therethrough. The collets may be temporarily expanded by, for
example, pushing a spreading mandrel into their horizontal slots,
and/or by loading the collets over a spreading mandrel. Sleeveless
collets may, for example, be formed of spring steel and/or one or
more other suitable materials.
[0245] Still other variations of tether locking devices may be
used. In some variations, a locking device may comprise a one-piece
locking component that is slid over a tether and then crimped into
place with the tether trapped inside. The locking component may be
formed of, for example, a malleable metal, such that the locking
component may be collapsed by drawing the locking component into a
catheter with a smaller inner diameter. As another example, a
polymer locking component may be configured to snap together and
lock when it is drawn into a catheter. In certain variations, a
locking component may be formed of a shape-memory alloy (e.g.,
Nitinol), such that the locking component may be held open during
delivery and then allowed to collapse onto a tether to lock the
tether.
[0246] In some variations, a locking component may be in the form
of a self-collapsing tube that is propped open by a catheter shaft.
In use, the tube may be pushed off the catheter shaft to allow the
tube to collapse and clamp on a tether. The tube may be made of,
for example, a spring-like material (e.g., Nitinol) or any other
suitable material. In some variations, the tube may initially have
an elliptical cross-section. In certain variations, the tube may
comprise a liner made of one or more polymers (e.g., polyurethane)
that fill up any gaps inside the tube. The tube may be propped open
into a more circular shape by the catheter shaft. A tether may run
through the inner lumen of the catheter shaft freely so that the
tube may be advanced over the tether to the target locking site by
advancing the catheter shaft over the tether. At the target locking
site, tension may be applied to the tether to provide a cinching
effect, and the tube may then be pushed off the delivery catheter
shaft, leading to its collapse onto the tether.
[0247] In some variations, a tether-locking effect may be achieved
by deploying a spring element that expands outward to clamp a
tether against an outer tube. For example, a locking device may
comprise an inner spring element disposed within an outer tube,
with a catheter shaft propping up a space between the inner spring
element and the outer tube. During use, a tether may be routed
through the inner lumen of the catheter shaft, and the tube-spring
combination may be pushed off the end of the catheter shaft to
remove the compressive effect of the catheter shaft and allow the
spring to expand outward, thereby clamping the tether against the
outer tube.
[0248] While certain variations of tether-locking tubular members
have been shown, additional variations of tubular members may be
used to lock a tether. As an example, FIGS. 47A and 47B show a
locking tube (4700). Locking tube (4700) comprises a wall portion
(4702) and a lumen (4704). Four apertures (4706), (4708), (4710),
and (4712) are formed in wall portion (4702). Two of the apertures
(4706) and (4710) are generally circular, while the other two
apertures (4708) and (4712) are horseshoe-shaped. In use, a tether
may be threaded through at least one of the apertures. Threading
the tether through one or more of the horseshoe-shaped apertures
may help to secure the tether, at least because the tether may
become somewhat compressed by the walls of the aperture or
apertures. Additionally, in some variations, a locking effect may
be enhanced by, for example, threading a tether through one of the
horseshoe-shaped apertures in one direction (e.g., the direction of
arrow (4703) in FIG. 47A), and then pulling the tether in the
opposite direction to cause the horseshoe shape to effectively dig
into the tether and secure it. While not shown, in certain
variations, a plug may be advanced into the lumen of the locking
tube to provide an additional locking effect on the tether.
[0249] While FIGS. 47A and 47B show one variation of a locking
tube, other variations may be used. For example, FIG. 48 shows a
locking tube (4800) having only horseshoe-shaped apertures (4802)
and (4804), while FIG. 49 shows a locking tube (4900) having only
elongated slits (4902), (4904), (4906), and (4908). A locking tube
may have any suitable number, combination, size, shape, and
configuration of apertures (e.g., holes, slits, etc.).
[0250] FIGS. 50A and 50B show an additional variation of a locking
device. As shown there, a locking device (5000) has a buckle
configuration comprising a strip (5002) having a first end (5004)
and a second end (5006), and a strap (5008) therebetween. A tether
(5010) has been routed over surfaces (5020) and (5022) of strip
(5002), and underneath strap (5008). Second end (5006) is
preferentially sprung to move in the direction of arrow (A3) toward
first end (5004) (FIG. 50A), to close the strip on itself and
thereby secure tether (5010) (FIG. 50B). The tether may be secured
because as the strip closes on itself, it converts the tether from
a linear configuration to a convoluted configuration that is less
likely to slide freely. In some variations, first end (5004) and/or
second end (5006) may comprise one or more features that help to
secure the first end to the second end, and thereby enhance the
locking of the tether. In certain variations, second end (5006) may
be configured to move toward first end (5004) when locking device
(5000) is deployed from a delivery device, such as a catheter.
[0251] Other variations of locking devices comprising different
portions that close toward each other to lock a tether may be used.
For example, FIGS. 50C-50F depict a locking device (5040)
comprising a body (5051) having grooves (5052), teeth (5054), a
hinge (5058) including an aperture (5056), and a tether-receiving
area (5055). As shown, grooves (5052) and teeth (5054) are sized
and shaped to form a snap-fit. However, in other variations,
different portions of a locking device may interlock by
friction-fit or any other suitable mechanism. Referring to both
FIGS. 50C and 50D, a tether (5060) may be threaded such that it
passes through tether-receiving area (5055), through the length of
locking device (5040), and through aperture (5056). When in an open
configuration, teeth (5054) may not be fully engaged in grooves
(5052), or may not be in grooves (5052) at all, and the locking
device may be slidable over the tether. In a closed configuration,
tether (5060) may be secured by moving portions (5050) and (5062)
toward each other, and positioning protrusion (5053) in
tether-receiving area (5055), thereby clamping the tether. Locking
device (5040) may assume a closed configuration by a variety of
mechanisms. For example, in some variations, locking device (5040)
may be disposed within a tubular member, and may be advanced
against a wedge in the tubular member to close the device. The
locking device may be retained in its closed configuration when
teeth (5054) are inserted into grooves (5052) to form, for example,
a snap-fit. Locking device (5040) may be manufactured using any
appropriate method. For example, in some variations, locking device
(5040) may be formed out of a single molded plastic or metal part,
as shown in the flattened configuration in FIG. 50E. Hinge (5058)
may be formed, for example, by bending the part along dotted lines
(5061).
[0252] FIG. 50F depicts one variation of a method of using locking
device (5040) to secure a tether (5060). As shown there, locking
device (5040) may be at least partially disposed within a tubular
member (5065) having angled walls (5064), such that the inner
diameter of tubular member (5065) decreases in the direction of
arrow (5067). A pulling feature (5070) may be releasably coupled to
locking feature (5040). As pulling feature (5070) is withdrawn in
the direction of arrow (5067) (e.g., proximally), locking device
(5040) may be advanced along angled walls (5064) from a region of
the tubular member with a larger diameter to a region with a
smaller diameter. As the locking device is pushed into the region
with a smaller diameter, the locking device becomes compressed,
such that teeth (5054) and grooves (5052) become secured to each
other. The engagement between the teeth and the grooves may fixedly
secure the locking device on tether (5060). In some variations,
actuating pulling feature (5070) in the direction of arrow (5067)
(e.g., by pulling on the pulling feature) may then cause locking
device (5040) to become decoupled from the pulling feature.
However, other suitable mechanisms may alternatively or
additionally be used to de-couple the locking device from the
pulling feature and/or tubular member. As an example, in some
variations, the pulling feature may be attached to the locking
device by a frangible or perforated region which may break when
sufficient force is applied. As another example, in certain
variations, a cutting element may be used to sever the connection
between the pulling feature and the locking device.
[0253] In some variations, and as shown schematically in FIGS. 51A
and 51B, a locking device (5100) may comprise two or more members
(here, plates (5102) and (5104)) that are capable of moving
relative to each other to secure a tether routed through apertures
in the members (here, apertures (5106) and (5108), respectively).
When locking device (5100) is in its locked configuration (FIG.
51A), the plates are positioned such that their apertures are not
directly aligned. As a result, a tether (5110) routed through the
apertures may effectively become locked by the device. Locking
device (5100) also has an open configuration (FIG. 51B) in which
apertures (5106) and (5108) are directly aligned. This direct
alignment may allow the tether to pass more freely through the
apertures, thereby effectively unlocking the tether. Different
configurations of devices may be used that incorporate this concept
of aligning apertures and moving apertures out of alignment to lock
and unlock a tether. The tether may function somewhat like a
drawstring in such cases.
[0254] In certain cases, multiple (i.e., at least two) tethers may
be wound together and effectively tangled to provide a locking
effect. This may be achieved, for example, by temporarily coupling
the tethers to a winding feature on a catheter, such as a Y-shaped
rod with each tether coupled to a leg. The rod may then be rotated
(e.g., on multiple axes) to wind the tethers together.
[0255] In some variations, a tether may have a feature that
effectively locks the tether in place. As an example, FIG. 52 shows
a tether (5200) having a bulbous member (5202) at one of its ends
(5204). The bulbous member may, for example, prevent the tether
from passing through one or more eyelets of an anchor to which the
tether is coupled. In certain variations, the bulbous member may
prevent the tether from becoming completely unlocked if, for
example, a locking device locking the tether fails. Bulbous member
(5202) may be formed, for example, by applying glue (e.g., fibrin,
a hydrogel, etc.) to the end of tether (5200) (e.g., in vivo).
While a bulbous member is shown, other appropriate configurations
may alternatively or additionally be used. Moreover, in some
variations, a tether may be frayed (e.g., using a cutting element
in vivo) to help increase the friction between the tether and one
or more of the locking device components, thereby enhancing the
securing of the tether.
[0256] FIGS. 53A and 53B illustrate a cam-based locking mechanism
that may be used to lock a tether. As shown there, a cam-based
locking mechanism (5300) comprises a first component (5302) and a
second component (5304). FIG. 53A shows the mechanism in its
unlocked state, when a tether (5306) disposed between first
component (5302) and second component (5304) can move freely
between the components. However, when second component (5304) is
rotated in the direction of arrow (A4), it engages tether (5306),
and locks the tether against first component (5302), as shown in
FIG. 53B. In some variations, second component (5304) may first be
rotated in a direction opposite that of arrow (A4), and may then be
released to secure the tether. While one cam-based locking
mechanism is shown, in certain variations, a locking device may
comprise two or more cam-based locking mechanisms, or at least one
cam-based locking mechanism in combination with one or more other
types of locking mechanisms.
[0257] FIG. 54 shows another variation of a locking device (5400).
Locking device (5400) comprises a first tubular member (5402)
connected to a second tubular member (5404) by a flexible strip
(5406). When one of the tubular members is rotated clockwise, while
the other tubular member is rotated counter-clockwise (as indicated
by the arrows), a tether (5408) that is threaded through the
tubular members may become locked. The rotation of the tubular
members may cause the tubular members to become off-axis with
respect to each other. In some variations, flexible strip (5406)
may be made of, for example, Nitinol, and may be shape-set to
create the rotation. Initially, locking device (5400) may be
constrained within a catheter, with the axes of tubular members
(5402) and (5404) aligned. This may be achieved, for example, by
using an alignment rod internal to the tubular members, an
alignment sleeve external to the tubular members, and/or one or
more alignment features within the catheter that maintain the ends
of the tubular members in an aligned configuration. After locking
device (5400) has been released from the catheter, flexible strip
(5406) may spring to its unconstrained position, such that tubular
members (5402) and (5404) are off-axis with respect to each other.
The same effect could be achieved by using a polymer flexible
strip. The polymer flexible strip may be molded or shape-set such
that in the unconstrained state, the tubular members are off-axis
with respect to each other.
[0258] Some methods may include clamping a tether to lock the
tether. As an example, FIG. 55 shows a locking device (5500)
comprising a clamping member (5502) and a tubular member (5504)
configured to receive the clamping member in a lumen (5506).
Clamping member (5502) comprises jaws (5508) and (5510) connected
to an elongated manipulating member (5511). Jaws (5508) and (5510)
have portions (5512) and (5514) comprising teeth (5516) and (5518).
While jaws (5508) and (5510) each have teeth in only one portion,
in some variations, jaws may have teeth along their entire length,
or may have teeth in multiple different portions. The elongated
manipulating member may be pushed to push the jaws out of the lumen
of the tubular member, or pulled to pull the clamping arms into the
lumen of the tubular member. The jaws may be used to clamp down on
a tether (not shown) outside of the tubular member, and then may be
retracted into the lumen of the tubular member to maintain the
clamp on the tether. More specifically, the tubular member may help
maintain the tether in a locked position by pushing down on the
jaws and keeping them clamped toward each other. Locking device
(5500) may, for example, provide relatively easily controlled
locking of one or more tethers.
[0259] Still other locking devices may be employed. For example,
FIG. 56A shows a locking device (5600) comprising a tubular member
(5602) comprising a lumen (5604), and a coil (5606) disposed within
the lumen of the tubular member. The coil itself has a lumen (not
shown), through which a tether (5608) has been threaded. The coil
is in its primary configuration when it is disposed within the
lumen of the tubular member (FIG. 56A). As shown in FIG. 56B, the
coil assumes a secondary configuration when it is no longer
disposed within the lumen of the tubular member (e.g., after the
tubular member has been withdrawn from the coil and/or the coil has
been pushed out of the lumen of the tubular member). Coils having
primary and secondary configurations may be formed, for example, by
heat-shaping the coils first on a primary mandrel, and then on a
secondary mandrel or shaping block. The secondary configuration
shown in FIG. 56B is helical, and it causes the tether to wind up
such that movement of the tether may be limited. Accordingly, the
tether may become locked by the coil. Coils may have different
secondary configurations. For example, FIG. 57 shows a coil (5700)
having a conical secondary configuration that locks a tether (5702)
routed through a lumen (not shown) of the coil. In some variations,
a tether may be configured to coil on its own. For example, the
tether may be pre-formed using heat-forming, and a mandrel may be
routed through the center of the tether to temporarily keep the
tether straight. The mandrel may later be removed when it is
desired for the tether to coil.
[0260] In some methods, it may be necessary to load a tether into a
device, such as a locking device, a cutting device, or a
combination locking and cutting device. Various methods and/or
devices may be used to accomplish this loading.
[0261] As an example, and referring now to FIGS. 58A and 58B, in
some variations, a tether (5834) may be loaded into a device (5800)
using a lasso (5804) which comprises a loop (5806) at one end. One
end of tether (5834) is threaded through loop (5806) of lasso
(5804). Lasso (5804) may then be pulled along the longitudinal axis
of device (5800) (FIG. 58A), to load tether (5834) into device
(5800). In alternative implementations, shown in FIG. 58B, a lasso
(5854) having a loop (5855) may be pulled through a side hole
(5858) in a device (5850) to load a tether (5880) into the device.
Device (5800) or device (5850) may be used to perform one or more
functions, such as locking and/or cutting (described in further
detail below). Lassos may be made from, for example, conventional
materials such as wire, suture, cable, string, or a monofilament. A
lasso may comprise a loop (as show in FIGS. 58A and 58B), a hook, a
coil, a tube, an elongate element with a hole, or any other
structure or material that can "grab" a tether.
[0262] While the use of tether-loading devices to load tethers into
locking devices has been described, such tether-loading devices may
have other uses, such as to load tethers into cutting devices or
combination locking and cutting devices (described in further
detail below). Other uses may also apply. Moreover, any of the
features described herein with respect to a locking device may also
be used, as appropriate, in a cutting device, or in a combined
locking and cutting device.
[0263] Additionally, while certain variations of tether-loading
devices have been described, other variations of devices may be
used to load tethers into locking devices and/or other types of
devices. For example, in some variations, a tether may be loaded
into a device, such as locking device or a cutting device, using
magnetic components. As an example, FIG. 58C shows one variation of
a locking device (5826) including two apertures (5827) and (5828)
sized and shaped for passage of a tether (5824) therethrough.
Tether (5824) comprises a first magnetic component (5822) at its
tip. First magnetic component (5822) may comprise a magnet (of a
first polarity), or one or more magnetic materials (e.g., metals
such as nickel or cobalt, metallic alloys, combinations thereof, or
the like). A second magnetic component may be located in the
proximity of an aperture in the locking device. For example, in
FIG. 58C, a second magnetic component (5821) is located on the
external surface of locking device (5826), near aperture (5828).
Second magnetic component (5821) may, for example, be a magnet of
the opposite polarity of first magnetic component (5822), or may
comprise any magnetic material or materials that substantially
attract first magnetic component (5822). In some variations, second
magnetic component (5821) may be directly attached to locking
device (5826), as shown in FIG. 58C. Magnetic components (5822) and
(5821) may be radiopaque, which may allow the location of locking
device (5826) to be tracked using X-ray fluoroscopy. Other
appropriate imaging modalities may alternatively or additionally be
used.
[0264] During use, tether (5824) may, for example, be threaded
through locking device (5826) by inserting the tether through
aperture (5827) and advancing the tether, which may be guided by
the attraction between first and second magnetic components (5822)
and (5821). While tether (5824) and locking device (5826) are shown
as each having one magnetic component in a particular position,
other variations of locking devices and tethers may have different
numbers and/or arrangements of magnetic components. In some
variations, the magnetic components and their configurations may be
selected based on the desired routing of a tether through a locking
device. Moreover, the path of a tether through a locking device may
be determined using both attractive and repulsive magnetic
forces.
[0265] In some circumstances, it may be inappropriate or
undesirable to introduce a magnetic material into a patient. In
some such cases, and as shown in FIG. 58D, a locking device (5836)
may comprise a removable magnetic component (5823) that is only
intended to be a part of the locking device when the locking device
is outside of the body of the subject (i.e., such that the
removable magnetic component is not implanted into the body of the
subject). Prior to locking device (5836) being inserted into a
patient, removable magnetic component (5823) may be used to thread
a tether (5824) from aperture (5837) to aperture (5838). Once the
desired tether path has been attained, removable magnetic component
(5823) may be removed from locking device (5836), and the locking
device may then be used in a body of a subject. While one variation
of a locking device with a removable magnetic component has been
described, it should be understood that other suitable variations
may also be used. In some variations, a magnetic "wand" (e.g.,
comprising an elongated member with a magnet at its distal end) may
be used to thread a tether through a locking device, when the
tether also comprises one or more magnets.
[0266] Tethers may be routed through a device, such as a locking
device or a cutting device, in any of a number of different
configurations. For example, FIGS. 59A and 59B show a variation of
a locking device (as shown, a locking catheter (5900)). Locking
catheter (5900) includes a tubular member (5902) having a wall
(5912) with four apertures (5904), (5906), (5908), and (5910)
formed in it. A locking catheter such as locking catheter (5900)
may be used, for example, to maintain tension in a tether, and to
stabilize the tether for cutting. In FIGS. 59A and 59B, a tether
(5914) has been threaded into locking catheter (5900), through
apertures (5904), (5906), (5908), and (5910). The tether may be
threaded into the locking catheter using, for example, a lasso,
such as one of the lassos described above. The lasso may have a
relatively flexible loop which may enhance the maneuverability of
the lasso through the apertures in the locking catheter.
[0267] While locking catheter (5900) is shown as including four
apertures through which tether (5914) is threaded, locking
catheters can include other numbers of apertures. For example, some
variations of locking catheters may include fewer apertures (e.g.,
two apertures), while other variations of locking catheters may
include more apertures (e.g., six apertures, eight apertures,
etc.). As the number of apertures in a locking catheter increases,
the likelihood of movement by a tether that is threaded through the
apertures may decrease.
[0268] As noted above, tethers may be routed through tubular
members or other elongated members in any appropriate tether
routing configuration. Different non-limiting examples of
tether-routing configurations are shown, for example, in FIGS.
60A-60R. As shown there, the proximal end of each tether is located
at the left-hand side of the figures, with the exception of FIG.
60R, in which the proximal end of the tether is located at the
right-hand side of the figure.
[0269] FIG. 60A shows a tether (6000) routed through two apertures
(6002) and (6004) in a wall portion (6006) of a tubular member
(6008) to form a loop (6005). Tether (6010) in FIG. 60B also forms
a loop (6011), but is routed through three apertures (6012),
(6014), and (6016) in a wall portion (6018) of a tubular member
(6020). FIG. 60C similarly shows a tether (6022) that forms a loop
(6023), and that also is routed through three apertures (6024),
(6026), and (6028) in a wall portion (6030) of a tubular member
(6032).
[0270] FIG. 60D shows a tether (6034) that is routed through two
apertures (6036) and (6038) in a wall portion (6040) of a tubular
member (6041), and also through a third aperture (6042) across from
apertures (6036) and (6038). In FIG. 60E, a tether (6044) is routed
through four apertures (6046), (6047), (6048), and (6049) in a wall
portion (6050) of a tubular member (6052). Tethers may be routed
through any number of apertures having any suitable size and/or
shape. The number, size, and/or shape of the aperture or apertures
through which a tether is routed may be selected, for example,
based on the desired level of security of the tether lock.
[0271] In some cases, a tether may be routed into and out of a
lumen of a tubular member multiple times. For example, FIG. 60F
shows a tether (6054) routed through a first aperture (6055) in a
wall portion (6056) of a tubular member (6057), such that the
tether enters a lumen (6058) of the tubular member. Tether (6054)
then exits the lumen via a second aperture (6059) in wall portion
(6056), and loops back around to re-enter the lumen via the distal
end (6053) of the tubular member. The tether then exits the lumen
once again via a third aperture (6060) in wall portion (6056).
[0272] Still further tether routing configurations are possible.
For example,
[0273] FIG. 60G shows a tether (6062) routed through a tubular
member (6064), FIG. 60H shows a tether (6065) routed through a
tubular member (6068), FIG. 60I shows a tether (6070) routed
through a tubular member (6072) such that the tether forms a loop
(6074) with an anchor (6076) slidably engaged along its center
portion, FIG. 60J shows a tether (6078) routed through a tubular
member (6080), and FIG. 60K shows a tether (6081) routed through a
tubular member (6082).
[0274] Additional tether routing configurations through various
different locking device components may be employed. For example,
FIG. 60L shows a tether (6083) routed through a locking tube (6084)
and through a sheath (6085) engaged with the locking tube, FIG. 60M
shows a tether (6086) routed through a locking tube (6087), and
FIG. 60N shows a tether (6088) routed through a locking tube
(6089). FIG. 60O shows a tether (6096) routed through a locking
tube (6097) such that the tether path forms an angle (.alpha.) with
respect to the longitudinal axis of the locking tube. Angle
(.alpha.) may be, for example, from about 5.degree. to about
70.degree. (e.g., from about 10.degree. to about 45.degree., or
about 45.degree.). This routing configuration may, for example,
allow for a relatively low passing force, and/or may allow for
tension in the tether to be released relatively easily. FIG. 60P
shows a tether (6090) routed through and around a locking tube
(6091), FIG. 60Q similarly shows a tether (6092) routed through and
around a locking tube (6093), and FIG. 60R shows a tether (6094)
routed through and around a locking tube (6095).
[0275] Tethers may be routed through the center of a lumen or
hollow portion of a locking tube or other locking member, or may be
routed so that they do not cross the center of the lumen or hollow
portion (e.g., to limit the likelihood of being pierced by a plug
tip).
[0276] In some variations, a tether may be routed along an outer
surface of a locking member (e.g., a locking tube). The tether may,
for example, be routed into or through one or more apertures and/or
grooves on the outer surface. In certain variations, a tether may
be wound around an outer surface of a locking member (e.g., a
locking tube). An outer surface of a locking member may include one
or more features (e.g., barbs, texturing, etc.) that help to retain
the tether. For example, the outer surface may be bead-blasted. In
some variations, a tether may be melted to an outer surface of a
locking member (e.g., by applying RF energy to the tether).
Alternatively, if it is desired for the tether not to engage with
the outer surface of a locking member, the outer surface may, for
example, be super polished.
[0277] In some cases, one or more components of a locking device
may be configured to couple with a tethered anchor. As an example,
a locking tube may comprise a slot configured to receive and couple
to an anchor. This may, for example, help to securely situate the
locking device component at a target site.
[0278] While methods using one locking device have been described,
it should be understood that multiple locking devices may be
employed to lock one or more tethers. The locking devices may be
the same as each other, or different from each other.
[0279] As described above, in operation, a locking device may be
used to secure a tether to fix the length of the tether and/or to
prevent the tether from moving. After the tether has been locked,
any excess length of the tether may be cut and removed. In some
variations in which a detachable locking member is used, a tether
may be cut to remove excess material either before or after
detaching the locking member from the rest of the device.
Generally, the tether may be cut proximal to the locking mechanism.
In many cases, it may be desirable to cut the tether as closely as
possible to the locking mechanism, while leaving enough excess
length to allow for any slippage that may occur. Examples of
various methods and devices that may be used to cut tethers are
described in more detail below.
[0280] FIG. 61A shows a cutting device (6101) that may be used to
cut a tether (6100) extending through anchors (6126). Cutting
device (6101) comprises a catheter (6105) and a tubular cutter
(6107) disposed within catheter (6105). As shown in FIG. 61A,
tether (6100) has been fixed by a locking element (6104), and has
been threaded into catheter (6105) such that it exits through a
side aperture (6106) in the catheter. Tether (6100) may be threaded
into catheter (6105) by any suitable method including, for example,
one or more of the methods described above. Tubular cutter (6107)
has an edge (6108) that is sufficiently sharp to cut a tether. For
example, tubular cutter (6107) may be in the form of a metal tube
having a sharpened edge. During use, tubular cutter (6107), which
may be attached to a flexible tube or a rod, may be advanced within
catheter (6105) such that the tubular cutter passes over side
aperture (6106). As tubular cutter (6107) is advanced over tether
(6100), tubular cutter (6107) shears off the excess portion of the
tether. While tubular cutter (6107) is tubular in shape, other
configurations of cutters may be used. For example, a cutter may be
semitubular (e.g., having a shape similar to a half-pipe), or may
have any other suitable configuration. In some variations, a cutter
may not be tubular or semitubular. As an example, a cutter may be
in the form of a flat blade.
[0281] In some variations, and as shown in FIG. 61B, a cutting
device (6143) comprises a catheter (6145), a base (6149) positioned
on an interior surface of the catheter, and a tubular cutter (6147)
concentrically disposed within the catheter. Tubular cutter (6147)
has an edge (6148) that is sufficiently sharp to cut a tether.
While cutter (6147) is tubular, other configurations of cutters may
be used. Base (6149) may, for example, be in the form of a block
that is attached to the interior surface of catheter (6145), or
that is integral with the interior surface of catheter (6145). Base
(6149) may be formed of any suitable material or materials, such as
any elastomeric or rigid material. FIG. 61B shows cutting device
(6143) being used to cut a tether (6134) extending through anchors
(6190), into catheter (6145), and through a side aperture (6146) in
catheter (6145). Prior to being cut, tether (6134) is fixed in
place by a locking element (6144). Then, tubular cutter (6147) is
advanced to cut tether (6134). Tubular cutter (6147) is advanced
against base (6149), which assists tubular cutter (6147) in cutting
tether (6134). In some variations, tubular cutter (6147) may be
spun or rotated to improve cutting.
[0282] Tubular cutters may have any suitable cutting edge
configuration. For example, a tubular cutter may have a beveled
cutting edge, as exemplified by tubular cutter (6155) of FIG. 61C,
a sharpened outer cutting edge, as exemplified by tubular cutter
(6156) of FIG. 61D, or a sharpened inner cutting edge, as
exemplified by tubular cutter (6157) of FIG. 61E. In addition, a
tubular cutter may have a serrated or saw-tooth pattern of sharp
protrusions around its perimeter to aid in cutting. Such variations
may be used, for example, when the tubular cutter is spun or
rotated during the cutting process.
[0283] In some variations, and as shown in FIG. 61F, a tubular
cutter (6160) may be positioned distal to a side aperture (6162) in
a catheter (6164). Tubular cutter (6160) may then be pulled in a
proximal direction toward side aperture (6162) (indicated by solid
arrow) to cut a tether (6170) extending through side aperture
(6162), which has been fixed by a locking element (6174). Pulling a
cutter proximally may provide for a relatively easy and/or
efficient way of cutting a tether, and/or for relatively controlled
tether-cutting.
[0284] FIG. 62 shows another variation of a cutting device. As
shown there, a cutting device (6200) comprises a tubular elongated
member (6202) having a lumen (6203), and a cutter (6204) disposed
within the lumen of the elongated member. Cutter (6204) has a
cutting blade (6206) that faces in a proximal direction. Elongated
member (6202) comprises a side wall (6208) having two apertures
(6210) and (6212) through which a tether (6214) may be threaded,
such that the tether crosses the lumen of the elongated member.
While two side wall apertures are shown, other variations of
devices may include a different number of side wall apertures, such
as three or four side wall apertures. When it is desired to sever
tether (6214), cutter (6204) may be pulled proximally using a
pulling member (6216) that is attached to cutter (6204). This
causes cutting blade (6206) to contact and sever tether (6214).
While cutter (6204) may be pulled proximally using pulling member
(6216), in some variations, a cutter disposed within the lumen of
an elongated member may alternatively or additionally be pushed in
a proximal direction. For example, a pushing member may be placed
into the elongated member at its distal end, and used to push the
cutter toward the proximal end of the elongated member.
[0285] The cutting devices shown above in FIGS. 61A-61F and 62
comprise cutters that are located internally of their catheters.
However, some variations of cutting devices include a catheter and
one or more cutters that are located externally of the catheter.
For example, as shown in FIG. 63A, a cutting device (6320) includes
a catheter (6345) and a tubular cutter (6350) that is configured to
slide along the exterior of catheter (6345). Tubular cutter (6350)
can, for example, be in the form of a sharpened metal tube (e.g.,
having a beveled edge). In some variations, and as shown, tubular
cutter (6350) is attached to a second tube (6351) which also is
configured to slide along the exterior of catheter (6345). In
certain variations, second tube (6351) can be flexible.
[0286] During use of cutting device (6320), a tether (6300) may be
threaded into catheter (6345), and may exit catheter (6345) through
a side aperture (6346). Tether (6300) may be threaded into catheter
(6345) using any suitable method, including methods described
herein. As tubular cutter (6350) is advanced in a distal direction
toward side aperture (6346), end (6353) of tubular cutter (6350)
severs tether (6300).
[0287] As shown in FIG. 63B, in some variations, a base (6354) may
be positioned along catheter (6345), to assist in the
tether-cutting process. During use, tether (6300) may be pushed
against base (6354) as tubular cutter (6350) is advanced toward
side aperture (6346). In certain variations, and as also shown in
FIG. 63B, a cover or shroud (6390) may be provided around tubular
cutter (6350) to limit the likelihood of sharpened end (6353)
catching on tissue or the like. In some variations, cover (6390) is
attached to second tube (6351).
[0288] While tubular cutters having certain configurations have
been shown, a tubular cutter may have any suitable configuration.
For example, as shown in FIG. 64A, a tubular cutter (6410) may have
a V-shaped cutting edge designed to channel a tether, such as
tether (6400). Tubular cutter (6410) is externally disposed
relative to a catheter (6412) having a side aperture (6414). During
use of tubular cutter (6410), tether (6400) is threaded through
side aperture (6414), so that it is positioned to be cut by tubular
cutter (6410).
[0289] While tubular cutter (6410) has a V-shaped cutting edge, any
other appropriate notched feature may be used on a cutter, and
other cutting edge configurations may also be used. As an example,
FIG. 64B shows a tubular cutter (6420) having a curved cutting
edge. Tubular cutter (6420) is externally disposed relative to a
catheter (6422) having a side aperture (6424). During use, a tether
(6426) may be threaded through side aperture (6424), so that it may
be severed by tubular cutter (6420). As another example, FIG. 64C
shows a tubular cutter (6430) having an angled cutting edge.
Tubular cutter (6430) is external to a catheter (6432) having a
side aperture (6434) through which a tether (6436) is threaded. As
an additional example, FIG. 64D shows a tubular cutter (6440)
having a serrated cutting edge. Tubular cutter (6440) is external
to a catheter (6442) having a side aperture (6444) through which a
tether (6446) is threaded. Additional cutting edge configurations
may be used, such as a saw-tooth cutting edge (not shown). The
latter two variations may be useful, for example, when the tubular
cutter is rotated or spun during the cutting process. In some
variations, the perimeter of a side aperture in a cutting catheter
may be sharpened to help cut the tether. Tubular cutters, as well
as other types of cutters, may be configured such that they operate
either externally or internally to a catheter.
[0290] In some variations, tubular cutters may be used to sever a
tether by cutting in a direction roughly perpendicular to the
longitudinal axis of a catheter. For example, one concentric tube
may be rotated relative to a second concentric tube to cut a
tether. As an example, in FIG. 65A, a tether (6500) enters a
catheter (6502) and exits through a side aperture (6504) in the
catheter. A tubular cutter (6506) is configured such that when it
is rotated about the longitudinal axis A-A' of catheter (6502), it
can slice tether (6500). For example, tubular cutter (6506) may
have an angled shape such that when it rotates about longitudinal
axis A-A', it cuts tether (6500). In some variations, tubular
cutter (6506) may be attached to a flexible tube (6508), as shown
in FIG. 65A. In certain variations (also shown in FIG. 65A), a
blocking structure (6510) may be disposed on catheter (6502).
Blocking structure (6510) may have any suitable shape, and may
serve as a base against which tether (6500) may be pushed during
the cutting process. Blocking structure (6510) may be attached to,
part of, or integral with, catheter (6502).
[0291] Other variations may also be used. As an example, FIG. 65B
shows a tether (6520) that is threaded through a catheter (6522)
and that exits through a side aperture (6524) in the catheter. A
tubular cutter (6526) is disposed around catheter (6522). Tubular
cutter (6526) has a cutting edge that is shaped to cut tether
(6520) in a direction generally orthogonal to longitudinal axis
A-A' of catheter (6522) as it is rotated around longitudinal axis
A-A'. Optionally, a blocking structure (6528) can be provided on
catheter (6522) such that tether (6520) is pushed against blocking
structure (6528) during the cutting process. Blocking structure
(6528) may be any suitable shape or have any suitable configuration
and may be attached to, part of, or integral with, catheter (6522).
While not shown, in some variations, tubular cutters such as those
illustrated in FIGS. 65A and 65B may be configured such that they
are internal to the catheter.
[0292] In some variations, a pair of concentric tubular cutters may
be used to cut a tether. The concentric tubular cutters may be
either internal or external to a catheter. For example, as
illustrated in FIG. 65C, two concentric tubular cutters (6550) and
(6552) are externally disposed relative to a catheter (6554).
Tubular cutters (6550) and (6552) may be rotated about the
longitudinal axis of catheter (6554) in opposite directions
(indicated by solid arrows). Thus, the cutting edges (6556) and
(6558) of the tubular cutters may cut a tether (6560) that is
routed through a side aperture (6562) in catheter (6554) in a
scissor-like fashion. Cutting edges (6556) and (6558) may be
sharpened in such a way to enable cutting edges (6556) and (6558)
to pass each other as closely as possible.
[0293] Tubular tether cutters have been described. However, in some
variations, a tether-cutting device may alternatively or
additionally comprise one or more non-tubular tether cutters. For
example, FIGS. 66A and 66B show a tether-cutting device (6600)
comprising a housing (6604), an aperture (6602) in the housing, a
mandrel (6601), and a blade (6603) having an aperture (6610). The
inner perimeter (6605) of blade aperture (6610) may serve as a
cutting edge. Housing (6604) may shield and/or stabilize blade
(6603). In the variation shown, blade (6603) is ring-shaped;
however, in other variations, a blade may have any other suitable
shape or size. Mandrel (6601) is coupled to blade (6603), and is
slidable within housing (6604).
[0294] Tether-cutting device (6600) may have at least two
configurations. The first configuration is shown in FIG. 66A. In
this configuration, inner perimeter (6605) of blade (6603) is
positioned so that it is substantially aligned with housing
aperture (6602). A tether may be threaded through aperture (6602),
as well as through inner perimeter (6605) of blade (6603). To cut
the tether, tether-cutting device (6600) may be converted into the
second configuration, shown in FIG. 66B, where mandrel (6601) may
be actuated in the direction of arrow (6608), which in turn may
actuate blade (6603) in the direction of arrow (6608). The tether
may be cut when inner perimeter (6605) of blade (6603) contacts or
crosses the edge of aperture (6602).
[0295] Alternate blade geometries may be used in other variations
of tether-cutting devices. For example, FIG. 66C shows a
tether-cutting device (6650) comprising blades (6651) and (6652),
which are angled such that they may substantially contact each
other to cut a tether therebetween. Tether-cutting device (6650)
comprises a housing (6656) that may stabilize blades (6651) and
(6652) and/or prevent the blades from inadvertently cutting tissue
during use, as well as a mandrel (6654) coupled to blade (6651).
While a mandrel is shown, any other appropriate actuating
mechanisms may alternatively or additionally be used. As shown,
during use a tether (6670) may be positioned between blades (6651)
and (6652), and mandrel (6654) may be used to actuate blade (6651),
such that blade (6651) contacts blade (6652) to cut tether
(6670).
[0296] Another variation of a tether-cutting device (6680) is shown
in FIG. 66D. As shown there, tether-cutting device (6680) comprises
blades (6681) and (6682), as well as a pair of mandrels (6684) that
actuate blade (6682) so that it contacts blade (6681), and thereby
cuts tether (6670). Other arrangements of dual-blade tether-cutting
devices, with different blade geometries, angles, and/or
configurations, may also be used to cut a tether. Moreover, while
single- and dual-blade tether-cutting devices have been described,
some variations of tether-cutting devices may comprise more than
two blades, such as three, four, or five blades.
[0297] As described above, a tether-cutting device may comprise any
appropriate structure or material. Additionally, tether-cutting
devices may comprise one or more tubular cutters, as described
above, and/or one or more tether cutters that cut by heat,
electricity, chemical reaction, or the like. For example, in some
variations, a tether-cutting device may comprise an electrode or
filament through which electrical energy is applied to cut a
tether.
[0298] In some variations, multiple cutting devices may be used
together to cut one or more tethers. The cutting devices may be the
same as each other or different from each other. Moreover, while
tether cutting has been described, in some variations, a tether may
not be cut, or the tether may be cut, but may still maintain some
length. The extra tether length may, for example, help to maintain
the tether in a locked state.
[0299] While locking devices and cutting devices have been
described, in some variations, a single device may provide both
locking and cutting functions.
[0300] For example, FIG. 67A shows a device (6701) that is in the
form of a catheter and that comprises a detachable locking element.
The device also includes a tubular tether cutter (6702) having a
sharpened outer edge (6704), and a pushing member (6715) that
passes through cutter (6702). Device (6701) further includes guides
which may guide a tether (6700) through the device and position the
tether for cutting. As shown in FIG. 67A, tether (6700) is
positioned through the device so that it can be readily cut by
cutter (6702) when the cutter is brought forward (e.g., by moving
the cutter distally). In FIG. 67A, cutter (6702) has at least one
edge (e.g., over half of the cutter's circumference) so that at
least one end of the tether (e.g., the end contacting the more
proximal end of the tether) is cut by the cutter.
[0301] As described above, other types of tether cutters may be
used as well. For example, FIG. 67B shows a device (6721)
comprising a similar tubular tether cutter (6710) that is
configured to cut the tether when the cutter is retracted
proximally. In FIG. 67B, cutter (6710) has a passage (6712) through
which a tether (6720) passes, and where at least a portion (6714)
of the cutter is sharp. Tether (6720) also passes through the wall
of the device (configured as a catheter in FIG. 67B, although other
suitable configurations may be used). The end of the tether may be
cut by drawing the tether taut after securing the locking element
of the device and then moving the cutter against the tether so that
it is cut.
[0302] In some variations, a locking and cutting device may
comprise a tether cutter located on the outer surface of a plug.
For example, FIGS. 68A-68J show an exemplary combined
tether-locking and -cutting device (6800). As shown there, device
(6800) comprises a tubular locking member (6801) and a plug (6803)
configured to fit within locking member (6801). Tubular locking
member (6801) includes several apertures (6802a) and (6802b) that
are sized and shaped for the passage of a tether (6820)
therethrough. In some variations, aperture (6802c) may also be
sized and shaped for the passage of a tether therethrough. However,
any number of apertures positioned in any way may be used, as
previously described (see, e.g., FIGS. 59A, 59B, and 60A-60R). Plug
(6803) comprises a plug body (6804) and a blade (6805) in a distal
portion (6806) of plug body (6804). It should be noted, though,
that other appropriate variations of plugs may alternatively or
additionally be used. During use, plug (6803) may be advanced into
locking member (6801) to secure tether (6820) between plug (6803)
and an inner wall of locking member (6801). Plug (6803) may be
advanced by pushing at the proximal portion (6807) using any
suitable mechanism. Additionally, as plug (6803) is advanced into
locking member (6801), blade (6805) may come into contact with
tether (6820), and may thereby cut the tether. Plug (6803) may be
advanced into locking member (6801) using any of the mechanisms and
methods previously described, or any other suitable mechanisms and
methods.
[0303] A tether cutter may be situated in any location on a plug.
Several non-limiting examples of tether cutters are illustrated in
FIGS. 68B-68J. First, FIG. 68B shows a plug (6822) comprising a
cutting member (6824) that outlines an outer perimeter of the plug.
While cutting member (6824) is located at one end of plug (6822), a
plug may optionally have a cutting member in either or both of its
proximal and distal portions. FIGS. 68C and 68J depict plugs (6826)
and (6854) having tether cutting members (6828) and (6856),
respectively, that are angled toward the distal portions (6827) and
(6855), respectively, of the plugs. FIGS. 68H and 68I depict plugs
(6846) and (6850) having tether cutting members (6848) and (6852),
respectively, that are angled toward the proximal portions (6847)
and (6851), respectively, of the plugs. FIGS. 68D-68G illustrate
variations of plugs having cutting members of different shapes and
locations. For example, cutting members may comprise sharp angles,
such as cutting members (6832) and (6836) in FIGS. 68D and 68E, or
may comprise rounded edges, such as cutting members (6840) and
(6844) in FIGS. 68F and 68G. Cutting members may also be located
toward one end of a plug, such as shown for plugs (6830) and (6838)
in FIGS. 68D and 68F, or located toward the opposite end of the
plug, such as shown for plugs (6834) and (6842) in FIGS. 68E and
68G. The above-described figures simply provide examples of plugs
that comprise a cutting member, and other appropriate variations
and configurations may also be used.
[0304] In some variations in which a plug comprises one or more
cutting members, the cutting members may be formed into the body of
the plug, and/or may be integral with the body of the plug. For
example, FIG. 69A shows a device (6999) comprising a plug (6900)
and a locking member (6910) configured to receive the plug. Plug
(6900) comprises a body (6902) having an edge (6904) with a
sharpened portion (6906). When plug (6900) is advanced into lumen
(6912) of locking member (6910), a tether (6914) may be secured
between plug (6900) and the wall of lumen (6912). When plug (6900)
is advanced further, sharpened portion (6906) of edge (6904) may
contact and cut tether (6914). The location of sharpened portion
(6906) within plug body (6902) may provide for a relatively
streamlined plug body. This, in turn, may provide for good surface
contact between the plug and the lumen, which may further secure a
tether passing therebetween.
[0305] While device (6999) has been described, other variations of
locking and cutting devices may be used, as appropriate. As an
example, FIG. 69B shows a plug (6920) comprising a plug body (6922)
having an edge (6924) with an angled sharpened portion (6926). The
angle of sharpened portion (6926) may be any suitable angle, for
example, from about 1.degree. to about 180.degree. (e.g., from
about 30.degree. to about 150.degree., from about 45.degree. to
about 135.degree., from about 60.degree. to about 120.degree., from
about 75.degree. to about 105.degree., etc.). As another example,
FIG. 69C shows a plug (6930) comprising a plug body (6932)
including a notch (6934) with a sharpened portion (6936). Other
variations of plugs may have notches of different shapes and/or
positions, where the sharpened portion may be located anywhere
along or in the notch. Moreover, some variations of plugs may have
multiple different sharpened portions. Both plug (6920) and (6930)
may be advanced into a locking member to first secure a tether, and
to then contact and cut the tether with the cutting member.
[0306] Other variations of plugs may comprise a cutting member that
encircles the perimeter of a plug. For example, FIG. 70A shows a
locking device (7099) comprising a plug (7000) and a locking member
(7004) configured to received the plug. As shown in FIG. 70A, plug
(7000) comprises a plug body (7001) and a cutting member (7002)
circumscribing the perimeter of plug body (7001). Plug (7000) may
be advanced into locking member (7004) by a pushing element (7006)
to first secure, and then cut, a tether (7008). While plug (7000)
is cylindrical, other variations of plugs with cutting members may
have any of a variety of different shapes, such as square,
polyhedral, etc., and the cutting members may be sized and shaped
to surround the outer perimeters of the plugs. Another variation of
a plug comprising a cutting member that traces the perimeter of the
plug is shown in FIG. 70B. As shown there, plug (7039) comprises a
cutting member (7021) located in a proximal portion (7038) of the
plug. A cutting member may have any sharpened edge that may be
suitable for cutting a tether. For example, a cutting member may
have angled sharpened edges as depicted in FIG. 70B, and/or may
have beveled, straight, or serrated sharpened edges, or the
like.
[0307] In some variations, a plug may comprise a cutting element
comprising a sharpened edge, where the cutting element is coupled
to the plug, but is actuated separately from the plug. An example
of such a plug is shown in FIG. 71. As shown there, a
tether-cutting and -locking device (7100) comprises a plug (7103)
and a locking member (7101) configured to receive plug (7103).
Locking member (7101) comprises two apertures (7104) and (7105)
through which a tether (7111) may be threaded. A lumen of locking
member (7101) may also comprise a notch (7113). Plug (7103) is
coupled to a cutting element (7107), such that a sharpened edge
(7115) of cutting element (7107) may be moved toward or away from
the plug. For example, cutting element (7107) may be slidable
within a channel in plug (7103), as shown in FIG. 71.
[0308] In some variations, plug (7103) may be actuated by a first
pushing member (7109), and cutting element (7107) may be actuated
by a second pushing member (7108). To lock and cut tether (7111)
that is threaded through locking member (7101), plug (7103) may
first be advanced into locking member (7101) by pushing on plug
(7103) with pushing member (7109). Cutting element (7107) may be
advanced in the direction of the plug (7103), but in some cases,
may not be advanced as far into locking member (7101) as the plug
is. Once tether (7111) has been secured between the plug and the
wall of the locking member, the tether, which is threaded such that
it crosses notch (7113), may be cut by pushing cutting element
(7107) further into locking member (7101), so that sharpened edge
(7115) contacts and cuts the tether against the notch. After tether
(7111) has been locked and cut, both pushing members (7108) and
(7109) may be withdrawn. In some variations, cutting element (7107)
may also be withdrawn. Such a variation of a locking and cutting
device may, for example, permit specific control of each of the
lock and cut functions, thereby limiting the likelihood of a tether
being cut prior to being fully secured.
[0309] In some combination locking and cutting devices, a locking
member may comprise a cutting member. One example of such a device
is depicted in FIGS. 72A and 72B. As shown there, a combination
locking and cutting device (7299) comprises a plug (7206) and a
locking member (7200) configured to receive the plug. Locking
member (7200) comprises a lumen (7208), an aperture (7214), and a
cutting member (7202). As shown, cutting member (7202) is located
within lumen (7208), at its distal end (7212). Cutting member
(7202) has an aperture (7204) sized and shaped for the passage of
at least one tether therethrough, as shown with reference to tether
(7210) in FIG. 72A. During use, plug (7206) may be advanced into
lumen (7208) to secure a tether (7210) between the walls of the
plug and the locking member. Advancing plug (7206) into locking
member (7200) may first secure the tether, and may then cut it by
causing the tether to contact cutting member (7202). As shown in
FIG. 72A, cutting member (7202) occupies a substantial portion of
lumen (7208); however, other variations of cutting members may
occupy a smaller portion of a lumen.
[0310] Referring now to FIG. 72B, another variation of a locking
member (7220) comprises a lumen (7224) and a cutting member (7222)
disposed within lumen (7224), where the cutting member only
occupies an upper portion of the lumen. This may, for example,
provide for enhanced contact between the plug, the tether, and the
locking member lumen wall, so that the tether may be secured more
readily. Of course, other shapes, locations, and configurations of
a cutting member within a locking member may also be used.
[0311] In some variations of combined locking and cutting devices
comprising a locking member and a plug, the locking member and the
plug may each comprise a cutting member. For example, FIGS. 73A and
73B show a combination locking and cutting device (7398) comprising
a plug (7314) and a locking member (7300) configured to receive
plug (7314). Locking member (7300) comprises a lumen (7306), two
apertures (7308) and (7310), and a first cutting member (7302).
Plug (7314) comprises a second cutting member (7304), in the form
of a sharpened edge. First and second cutting members (7302) and
(7304) are sized and shaped such that the sharpened portions of
each cutting member may substantially contact each other when plug
(7314) has been advanced into locking member (7300) (i.e., the plug
and locking member may have complementary shapes that interfit
together). For example, the angles of first and second cutting
members (7302) and (7304) may align with each other, as depicted in
FIGS. 73A and 73B. A tether (7312) may be threaded through locking
member (7300) in any suitable manner (such as described
previously), for example, from aperture (7310), through lumen
(7306), and out of aperture (7308). During use, plug (7314) may be
pushed into lumen (7306) to secure the tether against the wall of
the lumen (see the hatched portions shown in FIG. 73B).
Additionally, as plug (7314) is advanced, first and second cutting
members (7302) and (7304) may be brought together with tether
(7312) therebetween, and tether (7312) may be severed (e.g., when
the first and second cutting members contact each other as shown in
FIG. 73B, the tether may be cut).
[0312] Another variation of a combined locking and cutting device
comprising a locking member and a plug that each comprise a cutting
member is shown in FIGS. 73C and 73D. As depicted there, a combined
locking and cutting device (7399) comprises a plug (7334) and a
locking member (7320) configured to receive the plug. Locking
member (7320) comprises a lumen (7326), two apertures (7328) and
(7330), and a first cutting member (7322). In this variation, first
cutting member (7322) occupies a substantial portion of the
cross-section of lumen (7326), for example, cutting member (7322)
may be sized such that its cross-section is one-third or more of
the cross-section of lumen (7326). A cutting member with a
relatively large cross-section may, for example, help to ensure
that a tether secured between plug (7334) and locking member (7320)
is cut. Plug (7334) comprises a second cutting member (7324) that
is angled similarly to first cutting member (7322). This
arrangement of cutting members (7322) and (7324) may provide
increased contact with a tether (7312), so that the tether may be
fully severed. Other variations of combined locking and cutting
devices may comprise other cutting members having any suitable
configuration.
[0313] As described above, in some variations of combined locking
and cutting devices, a plug may be advanced by a pushing member
into the lumen of a locking member to secure a tether that is
threaded through the locking member. In certain variations, the
pushing member may comprise a cutting member that may cut the
tether (e.g., after it has been locked). Some variations of pushing
members comprising a cutting member are shown in FIGS. 74A and 74B.
First, FIG. 74A shows a combined locking and cutting device (7400)
comprising a plug (7407) and a locking member (7401) configured to
receive plug (7407). Locking member (7401) comprises two apertures
(7405) and (7406), which may be sized and shaped for threading a
tether (7403) therethrough, as depicted in FIG. 74A. Plug (7407)
may be engaged with locking member (7401), and advanced into the
locking member using a pushing member (7409). Pushing member
(7409), in turn, may comprise a rod (7413) and a cutting member
(7411). As plug (7407) is pushed into the locking member, the plug
may trap/wedge a tether (7403) against the wall of the locking
member lumen. As the plug continues to be advanced, cutting member
(7411) may contact and cut the portion of tether (7403) exiting
side aperture (7405). The length of rod (7413) may be adjusted, for
example, according to the location of side aperture (7405), so that
the tether may be sufficiently wedged/trapped before it is cut.
After tether (7403) has been secured in locking member (7401), and
cut by element (7411), pushing member (7409) may be withdrawn from
locking member (7401).
[0314] FIG. 74B shows another variation of a combined locking and
cutting device (7498) comprising a plug (7417) and a locking member
(7420) configured to receive the plug. As shown there, locking
member (7420) has a lumen therethrough, but no side aperture. Plug
(7417) may be pushed into the lumen of locking member (7420) by a
pushing member (7419) comprising a cutting element (7421). Pushing
the plug into the locking member may wedge and secure tether (7403)
along the entire length of plug (7417). After the tether has been
secured in the locking member, the portion of the tether exiting
the locking member (7420) may be contacted and cut by cutting
element (7421). Cutting element (7421) may be situated in any
appropriate location along pushing member (7419). As illustrated in
FIG. 74B, cutting element (7421) is located on the body of pushing
member (7419). However, in some variations, it may be located on
the proximal portion of pushing member (7419). This arrangement
may, for example, permit a longer length of the tether to be
secured to the locking member prior to cutting, thereby securing
the tether relatively tightly, while also allowing for tether
(7403) to be cut against pushing member (7419). In some variations,
such as some variations described previously, the locking member
and plug may be arranged so that tether (7403) is sheared.
[0315] Another variation of a pushing member comprising a cutting
element is shown in FIGS. 75A and 75B. As shown there, a combined
locking and cutting device (7500) comprises a plug (7507), a
locking member (7501) configured to receive plug (7507), and a
pushing member (7509). Pushing member (7509) comprises flexible
flaps (7511) in its distal portion (7505) that may cover cutting
elements (7513). Cutting elements (7513) may be covered by flaps
(7511) until pushing member (7509) has been advanced to the point
at which flaps (7511) contact a notch (7502) in locking member
(7501). This may cause flaps (7511) to peel back, thereby exposing
cutting elements (7513). Tether (7503) may also exit locking member
(7501) at notch (7502). Exposed cutting elements (7513) may contact
and cut the tether at notch (7502). Flaps (7511) may, for example,
function to prevent accidental contact with cutting elements
(7513), as well as to preserve the sharpness of the cutting
elements. The flaps may be made of any appropriate material, such
as silicone, rubber, polymers, and the like. While certain
variations of flaps have been shown, other variations of flaps may
alternatively or additionally be used. For example, in some
variations, flaps may be retracted to expose cutting elements by
actuating a flap-retracting mechanism (e.g., using a proximal
controller). This may relatively reliably ensure that cutting
elements (7513) will be fully exposed and ready to cut a
tether.
[0316] Yet another variation of a pushing member comprising a
cutting element is shown in FIG. 76. As shown there, a combined
locking and cutting device (7600) comprises a plug (7607), a
locking member (7601) configured to receive the plug, and a pushing
member (7609). Pushing member (7609) comprises a distal portion
(7605) comprising cutting members (7611) that may be sized and
shaped to fit within a notch (7602) on locking member (7601). As
pushing member (7609) urges plug (7607) into the lumen of locking
member (7601), a tether (7603) that has been routed through the
lumen may be wedged and secured between the plug and the lumen
wall. Tether (7603) exits the locking member at notch (7602). As
the pushing member is advanced, cutting elements (7611) may be
inserted into notch (7602), where the cutting elements contact and
cut the tether (7603). After the tether has been cut, pushing
member (7609) may be withdrawn. Of course, while locking members
with notches have been described, as shown previously, some
variations of locking members may not have a notch (e.g., FIG.
74A), while other variations of locking members may have multiple
notches.
[0317] Additional variations of devices that serve both a
tether-locking function and a tether-cutting function may be used,
as appropriate.
[0318] While certain variations of locking and/or cutting devices
and methods have been described above, other variations may be
used. As an example, in some variations, one or more locking and/or
cutting device components may include one or more radiopaque
markers (e.g., platinum markers). The markers may enhance
visualization of the components and identification of their
location during a procedure (e.g., under X-ray fluoroscopy). As
another example, in certain variations, a locking device may
comprise a tubular locking member and a plug, where the plug may be
advanced within the tubular locking member by a wedge underneath
the plug. A tether may be routed between the plug and an inner wall
of the tubular locking member, and the wedge may be used to move
the plug to secure the tether between the plug and the inner wall.
As an additional example, in some variations, a cutting device may
be used to cut a tether that is not under tension. In such
variations, the tether may be cut, for example, by forcing the
tether against a wall of the cutting device and using the wall as a
backing for cutting the tether. Moreover, some variations of
devices may be used to provide a cinching effect with a tether.
These devices may be used for any procedure where these functions
(or combinations thereof) are desired. Locking, cutting, and
cinching devices are described, for example, in U.S. Patent
Application Publication Nos. US 2006/0190030 A1 and US 2006/0122633
A1, and US 2008/0172035 A1, all of which were previously
incorporated by reference in their entirety.
[0319] While methods and devices have been described in some detail
here by way of illustration and example, such illustration and
example is for purposes of clarity of understanding only. It will
be readily apparent to those of ordinary skill in the art in light
of the teachings herein that certain changes and modifications may
be made thereto without departing from the spirit and scope of the
appended claims.
* * * * *