U.S. patent application number 16/216475 was filed with the patent office on 2019-05-02 for methods and systems for delivering an implant using a planetary gear actuation assembly.
This patent application is currently assigned to ABBOTT CARDIOVASCULAR SYSTEMS INC.. The applicant listed for this patent is ABBOTT CARDIOVASCULAR SYSTEMS INC.. Invention is credited to Matthew J. Gillick, Michael L. Green.
Application Number | 20190125565 16/216475 |
Document ID | / |
Family ID | 54542589 |
Filed Date | 2019-05-02 |
View All Diagrams
United States Patent
Application |
20190125565 |
Kind Code |
A1 |
Gillick; Matthew J. ; et
al. |
May 2, 2019 |
METHODS AND SYSTEMS FOR DELIVERING AN IMPLANT USING A PLANETARY
GEAR ACTUATION ASSEMBLY
Abstract
A system for delivering an implant including a handle, a
trigger, and an actuation assembly. The actuation assembly can be
configured to displace the outer tubular member in the proximal
direction a distance (d) relative to the handle and to separately
move the inner shaft member distally a distance (x) relative to the
handle upon deployment of the trigger from a first position to a
second position, and move the inner shaft member proximally a
distance (y) relative to the handle with no displacement of the
outer tubular member upon return of the trigger from the second
position to the first position.
Inventors: |
Gillick; Matthew J.;
(Murrieta, CA) ; Green; Michael L.; (Pleasanton,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ABBOTT CARDIOVASCULAR SYSTEMS INC. |
Santa Clara |
CA |
US |
|
|
Assignee: |
ABBOTT CARDIOVASCULAR SYSTEMS
INC.
SANTA CLARA
CA
|
Family ID: |
54542589 |
Appl. No.: |
16/216475 |
Filed: |
December 11, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14932900 |
Nov 4, 2015 |
10154920 |
|
|
16216475 |
|
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|
62075059 |
Nov 4, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
F16H 19/04 20130101;
A61F 2/9517 20200501; A61F 2/966 20130101; F16H 2057/02039
20130101; F16H 57/02 20130101; F16H 57/023 20130101 |
International
Class: |
A61F 2/966 20130101
A61F002/966; F16H 57/02 20120101 F16H057/02; F16H 19/04 20060101
F16H019/04 |
Claims
1. A system for delivering an implant, the implant to be disposed
within a distal end portion of an outer tubular member and
positioned to be engaged by a distal end portion of an inner shaft
member when the inner shaft member is moved distally relative to
the outer tubular member, the inner shaft member being disposed
within the outer tubular member and movable distally and proximally
relative to the outer tubular member, comprising: a handle; a
trigger operatively coupled to the handle; and an actuation
assembly operatively coupled to the trigger, the inner shaft
member, and the outer tubular member, wherein the actuation
assembly is configured to displace the outer tubular member in the
proximal direction a distance (d) relative to the handle and to
separately move the inner shaft member distally a distance (x)
relative to the handle upon deployment of the trigger from a first
position to a second position, and further wherein the actuation
assembly is configured to move the inner shaft member proximally a
distance (y) relative to the handle with no displacement of the
outer tubular member relative to the handle upon return of the
trigger from the second position to the first position.
2. The system claim 1, wherein the actuation assembly further
includes: a planet carrier, at least one planet gear operatively
coupled to the planet carrier, a sun gear shaft operatively engaged
with the planet gear, a ring gear operatively engaged with the
planet gear, a first clutch driver configured to limit the sun gear
shaft to uni-directional rotational motion, and a second clutch
driver configured to uni-directionally lock the sun gear shaft and
the planet carrier.
3. The system of claim 2, further comprising a gear train
functionally disposed between the trigger and the actuation
assembly, the gear train having: a trigger gear sector, a trigger
pinion operatively meshed with the trigger gear sector, a slide
pinion operatively coupled to the trigger pinion, and a slide rack
disposed on a slide and operatively meshed with the slide
pinion.
4. The system of claim 3, wherein the second clutch driver is
configured to uni-directionally lock the sun gear shaft and the
planet carrier such that the sun gear shaft, planet carrier and the
ring gear have a 1:1 ratio of rotation during deployment of the
trigger from the first position to the second position.
5. The system of claim 4, wherein the actuation assembly further
comprises a clutch release operatively coupled to the second clutch
driver and configured to prevent the second clutch driver from
uni-directionally locking the sun gear shaft and the planet carrier
when the clutch release is engaged by a stop.
6. The system of claim 5, wherein the stop is disposed on the
handle, and the stop engages the clutch release when the actuation
assembly has moved proximally a distance (z) along the handle.
7. The system of claim 5, wherein the clutch release comprises a
saw-tooth portion and wherein the stop comprises a resilient
abutment portion, and wherein the resilient abutment portion of the
stop engages the saw-tooth portion of the clutch release when the
actuation assembly has moved proximally a distance (z) along the
handle.
8. The system of claim 3, wherein the first clutch driver is
configured to limit the sun gear shaft to uni-directional motion
such that the sun gear shaft does not rotate during return of the
trigger from the second position to the first position and the
planetary gear rotates about the sun gear shaft.
9. The system of claim 8, wherein the sun gear shaft is
functionally coupled to the outer tubular member such that upon
deployment of the trigger from the first position to the second
position the sun gear shaft rotates and thereby causes the outer
tubular member to move proximally.
10. The system of claim 8, wherein the actuation assembly further
comprises a shuttle frame having the planet carrier, the planet
gear, the sun gear shaft, the ring gear, the first clutch driver
and the second clutch driver disposed thereon.
11. The system of claim 10, wherein the shuttle frame is fixedly
coupled to the outer tubular member.
12. The system of claim 11, wherein the sun gear shaft is
functionally coupled to the handle such that upon deployment of the
trigger from the first position to the second position the sun gear
shaft rotates and the shuttle frame moves proximally a distance
relative to the handle.
13. The system of claim 12, wherein the actuation assembly further
comprises an intermediate gear functionally disposed on the shuttle
frame between the sun gear shaft and the handle, and operatively
engaged with the sun gear shaft.
14. The system of claim 10, wherein the actuation assembly further
comprises a ratchet rack fixedly coupled to the inner shaft member
and disposed on the shuttle frame.
15. The system of claim 14, wherein the ratchet rack is operatively
meshed with the ring gear.
16. The system of claim 10, wherein the actuation assembly further
comprises at least one pin configured to engage at least one pin
track disposed within the handle to thereby guide the shuttle frame
along the handle.
17. The system of claim 16, wherein the at least one pin comprises
a first pin disposed through an axis of an intermediate gear
functionally disposed on the shuttle frame between the sun gear
shaft and the handle, and operatively engaged with the sun gear
shaft.
18. The system of claim 17, wherein the at least one pin comprises
a second and third pin, each of the second and third pin disposed
through the shuttle frame.
19. The system of claim 118, wherein the at least one pin comprises
a fourth pin disposed through an axis of the sun gear shaft.
20. The system of claim 10, wherein the actuation assembly further
comprises a plate disposed on the shuttle frame.
21. The system of claim 3, where the slide is coupled to a driving
rack.
22. The system of claim 21, wherein the driving rack is operatively
engaged with the planet carrier and the driving rack is supported
by the shuttle frame.
23. The system of claim 21, wherein the driving rack is fixedly
coupled to the slide.
24. The system of claim 21, wherein the driving rack is detachably
coupled to the slide.
25. The system of claim 3, wherein the sun gear shaft comprises a
sun gear portion, a sheath pinion, and a clutch engagement
portion.
26. The system of claim 3, wherein the planet carrier comprises a
circumferential pinion, a clutch component, and at least one
pin.
27. The system of claim 3, wherein the ring gear comprises a
circumferential pinion and a ring gear portion.
28. The system of claim 3, wherein the first clutch driver and the
second clutch driver each comprises a sun gear shaft engagement
portion and a clutch portion.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 14/932,900, filed on Nov. 4, 2015, now U.S.
Pat. No. 10,154,920, which claims priority to U.S. Provisional
Application No. 62/075,059, filed on Nov. 4, 2014, the entire
contents of which is incorporated herein by reference.
BACKGROUND
Field of Disclosed Subject Matter
[0002] The disclosed subject matter is directed to systems and
methods for delivering one or more medical devices, for example an
implant, and more specifically, a braided implant. The braided
implant, for example a stent or scaffold, can be disposed within a
delivery system having an actuation assembly configured to deliver
the braided implant using a reciprocating motion.
Description of Related Art
[0003] Conventional self-expanding stent delivery systems can
include a handle housing portion and an elongated shaft, wherein
the stent is disposed within a delivery portion at the distal end
of the shaft. To deploy the stent, an outer sheath is retracted
relative to the stent, whereby the stent is released from its
delivery configuration. In certain systems, an inner member having
a pushing mechanism disposed proximate to its distal end can be
used to push the stent from the outer sheath, while the outer
sheath is retracted.
[0004] However, there remains a need for a system and method for
more accurately delivering an implant using a relatively simple
motion and ease of use.
SUMMARY
[0005] The purpose and advantages of the disclosed subject matter
will be set forth in and apparent from the description that
follows, as well as will be learned by practice of the disclosed
subject matter. Additional advantages of the disclosed subject
matter will be realized and attained by the methods and systems
particularly pointed out in the written description and claims
hereof, as well as from the appended drawings.
[0006] To achieve these and other advantages and in accordance with
the purpose of the disclosed subject matter, as embodied and
broadly described, the disclosed subject matter is directed to
systems and methods for delivering an implant. For example, an
implant can be disposed within a distal end portion of an outer
tubular member of the system and positioned to be engaged by a
distal end portion of an inner shaft member of the system when the
inner shaft member is moved distally relative to the outer tubular
member. The inner shaft member can be disposed within the outer
tubular member and movable distally and proximally relative to the
outer tubular member. The system for delivering an implant can
include a handle, a trigger, operatively coupled to the handle, and
an actuation assembly operatively coupled to the trigger, the inner
shaft member, and the outer tubular member.
[0007] The actuation assembly as disclosed herein is a planetary
gear type assembly. Particularly, the actuation assembly can
include a planet carrier, at least one planet gear operatively
coupled to the planet carrier, a sun gear shaft operatively engaged
with the planet gear, a ring gear operatively engaged with the
planet gear, a first clutch driver configured to limit the sun gear
shaft to uni-directional rotational motion, and a second clutch
driver configured to uni-directionally lock the sun gear shaft and
the planet carrier. The actuation assembly disclosed herein is
configured to displace the outer tubular member in the proximal
direction a distance (d) relative to the handle and to separately
move the inner shaft member distally a distance (x) relative to the
handle upon deployment of the trigger from a first position to a
second position, and further the actuation assembly is configured
to move the inner shaft member proximally a distance (y) relative
to the handle with no displacement of the outer tubular member
relative to the handle upon return of the trigger from the second
position to the first position.
[0008] The second clutch driver can be configured to
uni-directionally lock the sun gear shaft and the planet carrier
such that the sun gear shaft, planet carrier and the ring gear have
a 1:1 ratio of rotation during deployment of the trigger from the
first position to the second position. The actuation assembly can
also include a clutch release operatively coupled to the second
clutch driver and configured to prevent the second clutch driver
from uni-directionally locking the sun gear shaft and the planet
carrier when the clutch release is engaged by a stop. The stop can
be disposed on the handle, and the stop can engage the clutch
release when the actuation assembly has moved proximally a distance
(z) along the handle. For example, the clutch release can include a
saw-tooth portion and the stop can include a resilient abutment
portion, the resilient abutment portion of the stop can engage the
saw-tooth portion of the clutch release when the actuation assembly
has moved proximally a distance (z) along the handle.
[0009] The first clutch driver can be configured to limit the sun
gear shaft to uni-directional motion such that the sun gear shaft
does not rotate during return of the trigger from the second
position to the first position and the planetary gear rotates about
the sun gear shaft. The sun gear shaft can be functionally coupled
to the outer tubular member such that upon deployment of the
trigger from the first position to the second position the sun gear
shaft rotates and thereby causes the outer tubular member to move
proximally relative to the handle.
[0010] As embodied herein, the actuation assembly can include a
shuttle frame having the planet carrier, planet gear, sun gear
shaft, ring gear, first clutch driver and second clutch driver
disposed thereon. The shuttle frame can be fixedly coupled to the
outer tubular member. The sun gear shaft can be functionally
coupled to the handle such that upon deployment of the trigger from
the first position to the second position the sun gear shaft
rotates and the shuttle frame moves proximally a distance relative
to the handle. Additionally, the actuation assembly can include an
intermediate gear functionally disposed on the shuttle frame
between the sun gear shaft and the handle, and operatively engaged
with the sun gear shaft.
[0011] Furthermore, the actuation assembly can include a ratchet
rack fixedly coupled to the inner shaft member and disposed on the
shuttle frame. The ratchet rack can be operatively engaged with the
planet carrier. The ratchet rack can be operatively engaged with
the ring gear.
[0012] The actuation assembly can be functionally coupled to the
trigger by a driving rack. The driving rack can be operatively
engaged with the ring gear and the driving rack can be supported by
the handle. The driving rack can be operatively engaged with the
planet carrier and the driving rack can be supported by the shuttle
frame.
[0013] As further embodied herein, the actuation assembly can
include at least one pin configured to engage at least one pin
track disposed within the handle to thereby guide the shuttle frame
along the handle. The at least one pin can include a first pin
disposed through an axis of an intermediate gear functionally
disposed on the shuttle frame between the sun gear shaft and the
handle. The at least one pin can include a second and third pin,
each of the second and third pin disposed through the shuttle
frame. The at least one pin can include a fourth pin disposed
through an axis of the sun gear shaft. The actuation assembly
further can include a plate disposed on the shuttle frame.
[0014] A sheath gondola can also be provided, disposed between the
outer tubular member and the sun gear shaft, wherein the sheath
gondola is functionally coupled to the sun gear shaft by a first
tension element. The actuation assembly can include a ratchet
gondola disposed between the inner tubular member and the ring
gear, wherein the ratchet gondola is functionally coupled to the
ring gear by a second tension element.
[0015] The sun gear shaft can include a sun gear portion, a sheath
pinion, and a clutch engagement portion. The planet carrier can
include a circumferential pinion, a clutch component, and at least
one pin. The ring gear can include a circumferential pinion and a
ring gear portion. The first clutch driver and the second clutch
driver can each include a sun gear shaft engagement portion and a
clutch portion.
[0016] As embodied herein, the actuation assembly can be
functionally coupled to the trigger by a driving rack. The trigger
can include a slide having an engagement surface to be engaged by
the user. The slide can be fixedly coupled to the driving rack.
[0017] The trigger of the disclosed subject matter can be
functionally connected to the driving rack by a gear train. The
gear train can include a trigger gear sector, a trigger pinion
operatively meshed with the trigger gear sector, a slide pinion
operatively coupled to the trigger pinion, and a slid rack disposed
on a slide coupled to the driving rack and operatively meshed with
the trigger pinion. The driving rack can be fixedly coupled to the
slide. The driving rack can be detachably coupled to the slide.
[0018] Alternatively, or additionally, the trigger can be
functionally connected to the driving rack by one or more link
elements. For example, a plurality of link elements can be
provided. The plurality of link elements can include a first linear
link coupled to the trigger at a first joint, a second linear link
coupled to the slide at a second joint, and a triangle link coupled
to the first linear link at a third joint and the second linear
link at a fourth joint. The triangle link can be coupled to the
handle at a fifth joint, and the trigger can be coupled to the
handle at a sixth joint. Each of the first, second, third, fourth,
fifth, and sixth joints can be pivot joints. The third joint,
fourth joint, and fifth joint thus can define a triangle. Upon
deployment of the trigger from the first position to the second
position and return of the trigger from the second position to the
first position, the third joint can trace a non-linear path.
Alternatively, the trigger can be functionally connected to the
driving rack by a trigger pulley system.
[0019] Furthermore, the system can include a ratchet mechanism
functionally coupled to the trigger. The ratchet mechanism can
include a first state configured to allow the trigger to move
toward the second position and prohibit motion toward the first
position. The ratchet mechanism can include a second state
configured to allow the trigger to move toward the first position
and prohibit motion toward the second position. As embodied herein,
the ratchet mechanism can include a first pawl and a trigger
ratchet rack configured to engage the pawl to permit unidirectional
motion of the slide. The pawl can include a first state wherein the
pawl engages the trigger ratchet rack to permit unidirectional
motion of the slide in a first direction. The pawl can include a
second state wherein the pawl engages the trigger ratchet rack to
permit unidirectional motion of the slide in a second direction.
The pawl can be configured to switch from the first state to the
second state as the trigger approaches the second position from the
first position. The pawl can be configured to switch from the
second state to the first state as the trigger approaches the first
position from the second position. The pawl can be configured to be
disengaged with the trigger ratchet rack by urging the pawl away
from the trigger ratchet rack. The pawl can be biased toward
engagement with the trigger ratchet rack.
[0020] Additionally, the ratchet mechanism can include a second
pawl having a first state wherein the second pawl engages the
ratchet rack to permit unidirectional motion of the slide in a
second direction. The first and second pawl can each have a second
state wherein the first and second pawl do not engage the trigger
ratchet rack, particularly when the other pawl is in engagement. In
this manner when the first pawl is in the first state the second
pawl can be in the second state and when the second pawl is in the
first state the first pawl can be in the second state. The ratchet
mechanism can also include a ratchet trip coupled to the first and
second pawls. As the trigger approaches the second position from
the first position the ratchet trip can cause the first pawl to
switch from the first state to the second state and the ratchet
trip can cause the second pawl to switch from the second state to
the first state. As the trigger approaches the first position from
the second position the ratchet trip can cause the first pawl to
switch from the second state to the first state and the ratchet
trip can cause the second pawl to switch from the first state to
the second state.
[0021] As disclosed herein, the trigger can be coupled to a spring
such that energy is stored in the spring upon deployment of the
trigger from the first position to the second position, and the
energy stored in the spring causes the trigger to return from the
second position to the first position. The system can include a
spring support coupled to the trigger and a base and configured to
engage the spring such that energy is stored in the spring when the
trigger is in the first position.
[0022] As further disclosed herein, a system for delivering an
implant is provided. The system can include a handle, as well as a
trigger, an outer tubular member, and an inner shaft member, each
operatively coupled to the handle. An implant can be provided with
the system as a kit or separately. The trigger can be movable
between a first position and a second position. The handle can
further have an actuation assembly operatively coupled to the
trigger. The outer tubular member can include a proximal end
portion and a distal end portion, wherein the outer member is
operatively coupled to the actuation assembly and movable in a
proximal direction relative to the handle. The inner shaft member
can include a proximal end portion and a distal end portion. The
inner shaft member is disposed within the outer tubular member and
operatively coupled to the actuation assembly. The inner shaft
member can be movable distally and proximally relative to the outer
tubular member. The implant can be disposed within the distal end
portion of the outer tubular member and positioned to be engaged by
the distal end portion of the inner shaft member when the inner
shaft member is moved distally relative to the outer tubular
member. The actuation assembly disclosed herein is configured to
displace the outer tubular member in the proximal direction a
distance (d) relative to the handle and to separately move the
inner shaft member distally a distance (x) relative to the handle
upon deployment of the trigger from the first position to the
second position, and further wherein the actuation assembly is
configured to move the inner shaft member proximally a distance (y)
relative to the handle with no displacement of the outer tubular
member relative to the handle upon return of the trigger from the
second position to the first position.
[0023] The distance (y) minus the distance (x) can substantially
equal the distance (d). Upon deployment of the trigger from the
first position to the second position and return of the trigger
from the second position to the first position, a net displacement
of the inner shaft member relative to the outer tubular member can
be zero. The braided implant can have a length, the length of the
braided implant can be less than the distance (x). Repeatedly
deploying the trigger from the first position to the second
position and returning the trigger from the second position to the
first position can cause the inner shaft member to urge the braided
implant from the outer tubular member. The actuation assembly can
be configured to displace the outer tubular member a distance (d)
in the proximal direction relative to the handle upon deployment of
the trigger from the first position to the second position. The
handle can be configured to fit within a hand of a user and upon
repeated deployment of the trigger from the first position to the
second position and return of the trigger from the second position
to the first position the actuation assembly can be configured to
move from a position within the handle distal of the user's hand to
a position within the handle proximal of the user's hand. The
actuation assembly can include a planetary gear system.
[0024] According to another embodiment of the disclosed subject
matter, a system for delivering an implant is provided. The system
can include a handle, a trigger operatively coupled to the handle,
and an actuation means configured to displace the outer tubular
member in the proximal direction a distance (d) relative to the
handle and to separately move the inner shaft member distally a
distance (x) relative to the handle upon deployment of the trigger
from a first position to a second position, and further wherein the
actuation assembly is configured to move the inner shaft member
proximally a distance (y) relative to the handle with no
displacement of the outer tubular member relative to the handle
upon return of the trigger from the second position to the first
position.
[0025] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and are intended to provide further explanation of the disclosed
subject matter claimed.
[0026] The accompanying drawings, which are incorporated in and
constitute part of this specification, are included to illustrate
and provide a further understanding of the disclosed subject
matter. Together with the description, the drawings serve to
explain the principles of the disclosed subject matter.
BRIEF DESCRIPTION OF THE FIGURES
[0027] FIG. 1 is a perspective view of an exemplary embodiment of a
delivery system in accordance with the disclosed subject
matter.
[0028] FIG. 2 is a right side view, with a portion of the handle
housing removed, of the delivery system of FIG. 1.
[0029] FIG. 3 is a left side view, with a portion of the handle
housing removed, of the delivery system of FIG. 1.
[0030] FIG. 4 provides a top perspective view of selected elements
of the actuation assembly of the delivery system of FIG. 1.
[0031] FIGS. 5A-5D provide perspective FIG. 5A, right--FIG. 5B,
left FIG. 5C, and front FIG. 5D views of the sun gear shaft of the
delivery system of FIG. 1.
[0032] FIGS. 6A-6D provide perspective FIG. 6A, right FIG. 6B, left
FIG. 6C, and front FIG. 6D views of the planet carrier of the
delivery system of FIG. 1.
[0033] FIGS. 7A-7D provide perspective FIG. 7A, right FIG. 7B, left
FIG. 7C, and front FIG. 7D views of the ring gear of the delivery
system of FIG. 1.
[0034] FIGS. 8A-8D provide perspective FIG. 8A, right FIG. 8B, left
FIG. 8C, and front FIG. 8D views of the first clutch driver of the
delivery system of FIG. 1.
[0035] FIGS. 9A-9D provide perspective FIG. 9A, right FIG. 9B, left
FIG. 9C, and front FIG. 9D views of the shuttle frame of the
delivery system of FIG. 1.
[0036] FIGS. 10A-10D provide perspective FIG. 10A, right FIG. 10B,
left FIG. 10C, and front FIG. 10D views of the intermediate gear of
the delivery system of FIG. 1.
[0037] FIGS. 11A-11D provide perspective FIG. 11A, right FIG. 11B,
left FIG. 11C, and front FIG. 11D views of the clutch release of
the delivery system of FIG. 1.
[0038] FIG. 12 is a perspective view illustrating the relationship
between the planet carrier and the planet gears of the delivery
system of FIG. 1.
[0039] FIGS. 13A-13D are various views depicting the relationship
between the sun gear shaft and the planet gears of the delivery
system of FIG. 1.
[0040] FIGS. 14A-14D are various views depicting the relationship
between the ring gear and the planet gears of the delivery system
of FIG. 1.
[0041] FIGS. 15A-15D are various views depicting relationship
between the sun gear shaft and the first and second clutch drivers
of the delivery system of FIG. 1.
[0042] FIG. 16 is a perspective view illustrating the relationship
between the sun gear shaft, the planet carrier, and the second
clutch driver of the delivery system of FIG. 1.
[0043] FIG. 17 is a perspective view illustrating the relationship
between the sun gear shaft, the first clutch driver, and the
shuttle frame of the delivery system of FIG. 1.
[0044] FIG. 18 is a side view illustrating the relationship between
the sun gear shaft, intermediate gear, and handle of the delivery
system of FIG. 1.
[0045] FIG. 19 is a perspective view illustrating the relationship
between the shuttle frame and the ratchet member of the delivery
system of FIG. 1.
[0046] FIG. 20 is a perspective view illustrating the relationship
between the ring gear and the ratchet member of the delivery system
of FIG. 1.
[0047] FIG. 21 is an enlarged view showing the relationship between
the handle, pins, and plate of the delivery system of FIG. 1.
[0048] FIGS. 22A-22C are various views showing the relationship
between the shuttle frame, driving rack, and planet carrier of the
delivery system of FIG. 1.
[0049] FIG. 23 is a side view showing the relationship between the
clutch release and the second clutch driver of the delivery system
of FIG. 1.
[0050] FIG. 24 is a perspective view of another exemplary
embodiment of a delivery system in accordance with the disclosed
subject matter.
[0051] FIG. 25 is a right side view, with a portion of the handle
housing removed, of the delivery system of FIG. 24.
[0052] FIG. 26 is a left side view, with a portion of the handle
housing removed, of the delivery system of FIG. 24.
[0053] FIGS. 27A-27D provide perspective FIG. 27A, right FIG. 27B,
left FIG. 27C, and front FIG. 27D views of the sun gear shaft of
the delivery system of FIG. 24.
[0054] FIGS. 28A-28D provide perspective FIG. 28A, right FIG. 28B,
left FIG. 28C, and front FIG. 28D views of the planet carrier of
the delivery system of FIG. 24.
[0055] FIGS. 29A-29D provide perspective FIG. 29A, right FIG. 29B,
left FIG. 29C, and front FIG. 29D views of the ring gear of the
delivery system of FIG. 24.
[0056] FIGS. 30A-30D provide perspective FIG. 30A, right FIG. 30B,
left FIG. 30C, and front FIG. 30D views of the first clutch driver
of the delivery system of FIG. 24.
[0057] FIGS. 31A-31D provide perspective FIG. 31A, right FIG. 31B,
left FIG. 31C, and front FIG. 31D views of the shuttle frame of the
delivery system of FIG. 24.
[0058] FIGS. 32A-32D provide perspective FIG. 32A, right FIG. 32B,
left FIG. 32C, and front FIG. 32D views of the intermediate gear of
the delivery system of FIG. 24.
[0059] FIGS. 33A-33D provide perspective FIG. 33A, right FIG. 33B,
left FIG. 33C, and front FIG. 33D views of the clutch release of
the delivery system of FIG. 24.
[0060] FIGS. 34A-34C are various views showing the relationship
between the shuttle frame, driving rack, and ring gear of the
delivery system of FIG. 24.
[0061] FIG. 35 is a perspective view showing the relationship
between the planet carrier and the ratchet member of the delivery
system of FIG. 24.
[0062] FIG. 36 is a perspective view of a yet another exemplary
embodiment of delivery system in accordance with the disclosed
subject matter.
[0063] FIG. 37 is a right side view, with a portion of the handle
housing removed, of the delivery system of FIG. 36.
[0064] FIG. 38 is a left side view, with a portion of the handle
housing removed, of the delivery system of FIG. 36.
[0065] FIGS. 39A-39D provide perspective FIG. 39A, right FIG. 39B,
left FIG. 39C, and front FIG. 39D views of the sun gear shaft of
the delivery system of FIG. 36.
[0066] FIGS. 40A-40D provide perspective FIG. 40A, right FIG. 40B,
left FIG. 40C, and front FIG. 40D views of the planet carrier of
the delivery system of FIG. 36.
[0067] FIGS. 41A-41D provide perspective FIG. 41A, right FIG. 41B,
left FIG. 41C, and front FIG. 41D views of the ring gear of the
delivery system of FIG. 36.
[0068] FIGS. 42A-42D provide perspective FIG. 42A, right FIG. 42B,
left FIG. 42C, and front FIG. 42D views of the first clutch driver
of the delivery system of FIG. 36.
[0069] FIGS. 43A-43D provide perspective FIG. 43A, right FIG. 43B,
left FIG. 43C, and front FIG. 43D views of the shuttle frame of the
delivery system of FIG. 36.
[0070] FIGS. 44A-44D provide perspective FIG. 44A, right FIG. 44B,
left FIG. 44C, and front FIG. 44D views of the intermediate gear of
the delivery system of FIG. 36.
[0071] FIGS. 45A-45D provide perspective FIG. 45A, right FIG. 45B,
left FIG. 45C, and front FIG. 45D views of the clutch release of
the delivery system of FIG. 36.
[0072] FIG. 46 is an exploded view of a further exemplary
embodiment of a delivery system in accordance with the disclosed
subject matter.
[0073] FIGS. 47A-47D provide perspective FIG. 47A, right FIG. 47B,
left FIG. 47C, and front FIG. 47D views of the sun gear shaft of
the delivery system of FIG. 46.
[0074] FIGS. 48A-48D provide perspective FIG. 48A, right FIG. 48B,
left FIG. 48C, and front FIG. 48D views of the planet carrier of
the delivery system of FIG. 46.
[0075] FIGS. 49A-49D provide perspective FIG. 49A, right FIG. 49B,
left FIG. 49C, and front FIG. 49D views of the ring gear of the
delivery system of FIG. 46.
[0076] FIGS. 50A-50D provide perspective FIG. 50A, right FIG. 50B,
left FIG. 50C, and front FIG. 50D views of the first clutch driver
of the delivery system of FIG. 46.
[0077] FIGS. 51A-51D provide perspective FIG. 51A, right FIG. 51B,
left FIG. 51C, and front FIG. 51D views of the shuttle frame of the
delivery system of FIG. 46.
[0078] FIG. 52 is a perspective view of another exemplary
embodiment of a delivery system in accordance with the disclosed
subject matter.
[0079] FIG. 53 is a right side view, with a portion of the handle
housing removed, of the delivery system of FIG. 52.
[0080] FIG. 54 is a left side view, with a portion of the handle
housing removed, of the delivery system of FIG. 52.
[0081] FIGS. 55A-55D provide perspective FIG. 55A, right FIG. 55B,
left FIG. 55C, and front FIG. 55D views of the sun gear shaft of
the delivery system of FIG. 52.
[0082] FIGS. 56A-56D provide perspective FIG. 56A, right FIG. 56B,
left FIG. 56C, and front FIG. 56D views of the planet carrier of
the delivery system of FIG. 52.
[0083] FIGS. 57A-57D provide perspective FIG. 57A, right FIG. 57B,
left FIG. 57C, and front FIG. 57D views of the ring gear of the
delivery system of FIG. 52.
[0084] FIGS. 58A-58D provide perspective FIG. 58A, right FIG. 58B,
left FIG. 58C, and front FIG. 58D views of the first clutch driver
of the delivery system of FIG. 52.
[0085] FIGS. 59A-59D provide perspective FIG. 59A, right FIG. 59B,
left FIG. 59C, and front FIG. 59D views of the shuttle frame of the
delivery system of FIG. 52.
[0086] FIGS. 60A-60D provide perspective FIG. 60A, right FIG. 60B,
left FIG. 60C, and front FIG. 60D views of the intermediate gear of
the delivery system of FIG. 52.
[0087] FIGS. 61A-61D provide perspective FIG. 61A, right FIG. 61B,
left FIG. 61C, and front FIG. 61D views of the clutch release of
the delivery system of FIG. 52.
[0088] FIG. 62 is a perspective view of a further exemplary
embodiment of a delivery system in accordance with the disclosed
subject matter.
[0089] FIG. 63 is a right side view, with a portion of the handle
housing removed, of the delivery system of FIG. 62.
[0090] FIG. 64 is a left side view, with a portion of the handle
housing removed, of the delivery system of FIG. 62.
[0091] FIGS. 65A-65D provide perspective FIG. 65A, right FIG. 65B,
left FIG. 65C, and front FIG. 65D views of the sun gear shaft of
the delivery system of FIG. 62.
[0092] FIGS. 66A-66D provide perspective FIG. 66A, right FIG. 66B,
left FIG. 66C, and front FIG. 66D views of the planet carrier of
the delivery system of FIG. 62.
[0093] FIGS. 67A-67D provide perspective FIG. 67A, right FIG. 67B,
left FIG. 67C, and front FIG. 67D views of the ring gear of the
delivery system of FIG. 62.
[0094] FIGS. 68A-68D provide perspective FIG. 68A, right FIG. 68B,
left FIG. 68C, and front FIG. 68D views of the first clutch driver
of the delivery system of FIG. 62.
[0095] FIGS. 69A-69D provide perspective FIG. 69A, right FIG. 69B,
left FIG. 69C, and front FIG. 69D views of the clutch release of
the delivery system of FIG. 62.
[0096] FIGS. 70A-70D provide perspective FIG. 70A, right FIG. 70B,
left FIG. 70C, and front FIG. 70D views of the ratchet gear of the
delivery system of FIG. 62.
[0097] FIGS. 71A-71D provide perspective FIG. 71A, right FIG. 71B,
left FIG. 71C, and front FIG. 71D views of the sheath gondola of
the delivery system of FIG. 62.
[0098] FIGS. 72A-72D provide perspective FIG. 72A, right FIG. 72B,
left FIG. 72C, and front FIG. 72D views of the ratchet gondola of
the delivery system of FIG. 62.
[0099] FIGS. 73A-73D provide perspective FIG. 73A, right FIG. 73B,
left FIG. 73C, and front FIG. 73D views of the clutch ring of the
delivery system of FIG. 62.
[0100] FIG. 74 is a left side view, with a portion of the handle
housing removed, of the delivery system of FIG. 62.
[0101] FIG. 75 is an enlarged in view of a portion of the delivery
system of FIG. 63.
[0102] FIG. 76 provides a top perspective view of selected elements
of the trigger assembly of the delivery system of FIG. 1.
[0103] FIGS. 77A-77D provide perspective FIG. 77A, right FIG. 77B,
left FIG. 77C, and front FIG. 77D views of the trigger of the
delivery system of FIG. 1.
[0104] FIGS. 78A-78D provide perspective FIG. 78A, right FIG. 78B,
left FIG. 78C, and front FIG. 78D views of the trigger pinion of
the delivery system of FIG. 1.
[0105] FIGS. 79A-79D provide perspective FIG. 79A, right FIG. 79B,
left FIG. 79C, and front FIG. 79D views of the slide pinion of the
delivery system of FIG. 1.
[0106] FIGS. 80A-80D provide perspective FIG. 80A, right FIG. 80B,
left FIG. 80C, and front FIG. 80D views of the slide of the
delivery system of FIG. 1.
[0107] FIGS. 81A-81D provide perspective FIG. 81A, right FIG. 81B,
left FIG. 81C, and front FIG. 81D views of the base of the delivery
system of FIG. 1.
[0108] FIG. 82 is a perspective view illustrating the relationship
between selected elements of the delivery system of FIG. 1.
[0109] FIG. 83 provides a perspective view of the spring of the
delivery system of FIG. 1.
[0110] FIGS. 84A-84C are various views depicting the spring support
of the delivery system of FIG. 1.
[0111] FIGS. 85A-85D are various views depicting selected elements
and the relationship between selected elements of the ratchet
mechanism of the delivery system of FIG. 1.
[0112] FIG. 86 is a right side view, with a portion of the handle
housing removed, of the delivery system of FIG. 24.
[0113] FIG. 87 is a left side view, with a portion of the handle
housing removed, of the delivery system of FIG. 24.
[0114] FIGS. 88A-88D provide various views of selected elements and
the relationship between selected elements of the ratchet mechanism
of the delivery system of FIG. 24.
[0115] FIG. 89 is a perspective view of the delivery system of FIG.
36.
[0116] FIG. 90 is a right side view, with a portion of the handle
housing removed, of the delivery system of FIG. 36.
[0117] FIG. 91 is a left side view, with a portion of the handle
housing removed, of the delivery system of FIG. 36.
[0118] FIG. 92 is an exploded view of the delivery system of FIG.
46.
[0119] FIG. 93 is a right side view, with a portion of the handle
housing removed, of the delivery system of FIG. 52.
[0120] FIG. 94 is a left side view, with a portion of the handle
housing removed, of the delivery system of FIG. 52.
[0121] FIG. 95 is a right side view, with a portion of the handle
housing removed, of the delivery system of FIG. 62.
[0122] FIG. 96 is a left side view, with a portion of the handle
housing removed, of the delivery system of FIG. 62.
DETAILED DESCRIPTION
[0123] Reference will now be made in detail to the various
exemplary embodiments of the disclosed subject matter, exemplary
embodiments of which are illustrated in the accompanying drawings.
The structure and corresponding method of making and using the
disclosed subject matter will be described in conjunction with the
detailed description of the delivery system. The methods and
systems described herein can be used for delivering a medical
device, such as a stent, scaffold stent graft, valve, filter, or
other suitable implant to a desired location in a patient.
[0124] Generally, and as set forth in greater detail, the disclosed
subject matter provided herein includes a delivery system having a
handle, a trigger, and an actuation assembly. The trigger is
operatively coupled to the handle. The actuation assembly is
operatively coupled to the trigger, the inner shaft member, and the
outer tubular member. As used herein the terms "functionally" and
"operatively" as used with "coupled," "engaged," or "connected,"
are interchangeable and understood by one of skill in the art. The
actuation assembly includes a planet carrier, at least one planet
gear operatively coupled to the planet carrier, a sun gear shaft
operatively engaged with the planet gear, a ring gear operatively
engaged with the planet gear, a first clutch driver configured to
limit the sun gear shaft to uni-directional rotational motion, and
a second clutch driver configured to uni-directionally lock the sun
gear shaft and the planet carrier. The actuation assembly is
configured to displace the outer tubular member in the proximal
direction a distance (d) relative to the handle and to separately
move the inner shaft member distally a distance (x) relative to the
handle upon deployment of the trigger from a first position to a
second position, and further wherein the actuation assembly is
configured to move the inner shaft member proximally a distance (y)
relative to the handle with no displacement of the outer tubular
member relative to the handle upon return of the trigger from the
second position to the first position.
[0125] In accordance with the described subject matter, a trigger
assembly for a delivery system is also provided. The trigger
assembly includes a trigger functionally connected to the actuation
assembly by a driving rack, a gear train functionally disposed
between the trigger and the driving rack. The gear train includes a
trigger gear sector, a trigger pinion operatively meshed with the
trigger gear sector, a slide pinion operatively coupled to the
trigger pinion, and a slide rack disposed on a slide coupled to the
driving rack and operatively meshed with the trigger pinion.
[0126] A variety of types of medical devices are suitable for
delivery by the delivery system of the present invention. For
purpose of illustration and not limitation, the delivery system is
described herein with a medical device depicted as a self-expanding
stent. Particularly, although not by limitation, reference is made
herein to the implant being a braided stent or scaffold for purpose
of illustration only. However, the delivery system presently
disclosed is not limited to the delivery of self-expanding stents.
Other devices can also be used. For example, scaffolds, coils,
filters, stent grafts, embolic protection devices, and artificial
valves can be delivered within a patient's vasculature, heart, or
other organs and body lumens using the disclosed delivery system.
Other devices such as a prosthesis retrieval mechanism can also be
delivered with the delivery system to a predetermined location in a
patient's luminal system. Moreover, a combination of medical
devices and/or beneficial agents can also be delivered using the
disclosed subject matter. For example, multiple stents and/or a
combination of stents and embolic protection devices and/or
beneficial agents can be delivered by the disclosed subject matter,
as described below. Additional information related to delivery of
implants can be found in U.S. application Ser. No. 11/876,764,
filed on Oct. 22, 2007, and U.S. application Ser. No. 13/118,325,
filed on May 27, 2011, each of which is incorporated by reference
in its entirety herein.
[0127] Referring to FIG. 1 for the purpose of illustration and not
limitation, various embodiments of the delivery systems disclosed
herein generally can include a handle 1, an outer tubular member
22, and an inner shaft member 21. An implant 23, for example, a
braided implant can be provided with the system or independently.
The handle can include a trigger assembly including a trigger 60
movable between and first position and a second position, and an
actuation assembly 2 (see e.g., FIG. 3) operatively coupled to the
trigger 60. The outer tubular member 22 can include a proximal end
portion and a distal end portion. The outer tubular member 22 can
be operatively coupled to the actuation assembly 2 and can be
movable in a proximal direction relative to the handle 1. A
stabilizer tube (not shown) can be disposed over at least the
proximal end portion of the outer tubular member 22, and a strain
relief 15 can be used to couple the stabilizer tube and the handle
1. The inner shaft member 21 can include a proximal end portion and
a distal end portion. The inner shaft member 21 can be disposed
within the outer tubular member 22 and can be operatively coupled
to the actuation assembly 2. The inner shaft member 21 of the
disclosed delivery system is movable distally and proximally
relative to the outer tubular member 22. The implant 23 can be
disposed within the distal end portion of the outer tubular member
22 and can be positioned to be engaged by the distal end portion of
the inner shaft member 21 when the inner shaft member is moved
distally relative to the outer tubular member 22. The distal end
portion of the inner shaft member 21 can have a pushing mechanism
disposed thereon. For example, U.S. application Ser. No.
13/118,325, filed on May 27, 2011, which is incorporated by
reference in its entirety herein, discloses suitable pusher
elements for the delivery system. The outer tubular member 22 is
depicted with a break in FIG. 1 to indicate that the length shown
is only exemplary and the outer tubular member 22 and inner shaft
member 21 can be longer than shown. Indeed, any suitable length can
be used. As an example and not by way of limitation, the outer
tubular member 22 and inner shaft member 21 can be long enough to
extend from outside the body of a patient through a tortuous path
to a treatment location within the body of a patient. The handle 1
can further include a luer lock at the proximal end of the handle
to receive a guidewire therethrough which can extend through the
inner shaft member and/or a flushing device as desired.
[0128] The actuation assembly 2 of the disclosed subject matter is
configured to displace the outer tubular member 22 in the proximal
direction a distance (d) relative to the handle 1 and to separately
move the inner shaft member 21 distally a distance (x) relative to
the handle 1 upon deployment of the trigger 60 from the first
position to the second position. Furthermore, the actuation
assembly 2 is configured to move the inner shaft member 21
proximally a distance (y) relative to the handle 1 with no
displacement of the outer tubular member 22 relative to the handle
1 upon return of the trigger 60 from the second position to the
first position. Put another way, the actuation assembly 2 can be
configured to move the outer tubular member 22 in a proximal
direction relative to the handle 1 and to separately move the inner
shaft member 21 distally relative to the outer tubular member 22
upon deployment of the trigger 60 form the first position to the
second position. The actuation assembly 2 can further be configured
to move the inner shaft member 21 proximally relative to the outer
tubular member 22 with no displacement of the outer tubular member
22 relative to the handle 1 upon return of the trigger 60 from the
second position to the first position. Repeatedly deploying the
trigger 60 from the first position to the second position and
returning the trigger from the second position to the first
position can cause the inner shaft member 21 to urge the implant 23
from the outer tubular member 22.
[0129] The distance (y) minus the distance (x) can be substantially
equal to the distance (d). Upon deployment of the trigger 60 from
the first position to the second position and return of the trigger
60 from the second position to the first position a net
displacement of the inner shaft member 21 relative to the outer
tubular member 22 thus can be zero. The implant 23 can have a
length, and the length of the implant 23 can be less than the
distance (x). Example lengths of the implant 23, for purpose of
illustration and not limitation, can be 20 mm, 30 mm, 40 mm, 60 mm,
80 mm, 100 mm, 120 mm, and 150 mm.
[0130] The distances (d), (x) and (y) can be selected based at
least in part on the diameter of the implant to be delivered, the
desired compression of the implant to be delivered, the path
between the insertion point and the location of implant delivery,
and/or other variables. As an example, and not by way of
limitation, for a stent having a diameter of 4.5 mm when delivered
to the vasculature, (d) can be about 12 mm, (x) can be about 28 mm,
and (y) can be about 40 mm. As another example and not by way of
limitation, the ratio (referred to herein as the "gear ratio")
between the net distal motion of the inner shaft member 21 relative
to the outer shaft member 22 (i.e., the distance (d) plus the
distance (x)) to the distance (d) can be greater than 3. As an
example, the gear ratio of (12+28):(12) is about 3.3. The actuation
assembly disclosed herein having such a gear ratio can be used to
properly deploy a braided stent from an extended delivery
configuration to an expanded deployed configuration and address a
3:1 change in length of the stent from the delivery length to the
deployment length. Exemplary diameters for stents when delivered to
the vasculature can range from 4 mm to 12 mm or greater, such as,
exemplary diameters can be 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm,
7.5 mm, or 8 mm, or suitable increments therebetween.
[0131] For the purpose of illustration, and not limitation, an
exemplary embodiment of a system for delivering an implant is shown
in FIG. 1 and is designated generally by reference character 1000.
Portions of this exemplary embodiment are depicted in FIGS. 2-23.
The handle 1 can include a first handle housing portion 1a and a
second handle housing portion 1b. The system can also include a
trigger 60. The trigger 60 can be operatively coupled to the
handle, such that the trigger 60 can be moveable between a first
position and a second position. As embodied herein, the trigger can
be biased towards the first or second position, for example, by a
spring. A ratchet mechanism 80 can be provided to prevent moving
the trigger between the first and second positions, such as to
require a full stroke in one or both directions as desired.
Additionally, a trigger stop 67 (FIG. 2) can be provided. The
trigger stop 67 can be disposed between the trigger 60 and the
handle 1, and can limit how far the trigger 60 can be actuated. The
size of trigger stop 67 can be selected based at least in part on
the diameter of the stent to be delivered, the desired compression
of the stent to be delivered, the path between the insertion point
and the location of stent delivery, and/or other variables. Indeed,
the system can include a trigger lock 1e, which can prevent any
motion of the trigger. For example, the trigger lock 1e can be
engaged prior to use (e.g., during shipping) and can be disengaged
in anticipation of use of the system.
[0132] The system 1000 also includes an actuation assembly 2. The
actuation assembly 2 is operatively coupled to the trigger 60, the
inner shaft member 21 and the outer tubular member 22 to provide
the desired relative movement as set for in detail above.
[0133] FIG. 4 shows for the purpose of illustration and not
limitation, selected elements or components of the actuation
assembly of the delivery system 1000. That is, FIGS. 5-11 show for
the purpose of illustration and not limitation, selected components
of an actuation assembly 2. FIGS. 12-23 show for the purpose of
illustration and not limitation, the relationship between selected
components of an actuation assembly 2. As noted above, the
actuation assembly 2 can be configured to displace the outer
tubular member 22 in the proximal direction a distance (d) relative
to the handle 1 and to separately move the inner shaft member 21
distally a distance (x) relative to the handle 1 upon deployment of
the trigger 60 from the first position to the second position. The
actuation assembly 2 can be configured to move the inner shaft
member 21 proximally a distance (y) relative to the handle 1 with
no displacement of the outer tubular member 22 relative to the
handle 1 upon return of the trigger 60 from the second position to
the first position.
[0134] As depicted herein, the actuation assembly 2 can include a
planetary gear system. For example, the actuation assembly can
include a planet carrier 5, at least one planet gear 6, a sun gear
shaft 3, a ring gear 7, a first clutch driver 4a and a second
clutch driver 4b. The actuation assembly can include a shuttle
frame 9. The shuttle frame can have the planet carrier 5, the
planet gears 6, the sun gear shaft 3, the ring gear 7, and the
first and second clutch drivers 4a, 4b disposed thereon. Shuttle
frame 9 can be disposed within the handle 1 and can be moveable
relative to the handle 1 along the length of the handle 1.
[0135] The sun gear shaft 3 (FIG. 5) can include a sun gear portion
3a, a sheath pinion 3b, a clutch engagement portion 3c, and a step
portion 3d. As depicted herein, the clutch engagement portion 3c
can be saw-toothed, although other suitable configurations can be
used. The planet carrier 5 (FIG. 6) can include a circumferential
pinion 5a, a clutch component 5b, and at least one pin 5c. The
planet carrier 5 will include one pin 5c for each planet gear 6.
For example, as shown at least in FIG. 6, the planet carrier 5
includes three pins 5c. The ring gear 7 (FIG. 7) can include a
circumferential pinion 7a and a ring gear portion 7b. Each clutch
driver 4a, 4b (FIG. 8) can be identical in shape, and can include a
sun gear shaft engagement portion 4c and a clutch portion 4d. The
sun gear shaft engagement portion 4c can be saw-toothed, although
other suitable configurations can be used.
[0136] The planet carrier 5 thus operates as the "planet carrier"
of the planetary gear system. As such, the at least one planet gear
6 can be operatively coupled to the planet carrier 5. Each planet
gear 6 can be operatively coupled to a pin 5c of the planet carrier
5, as shown in FIG. 12 for the purpose of illustration and not
limitation. In the exemplary embodiment, the system includes three
planet gears 6 operating as the "planet gears" of the planetary
gear system; however, one, two, four or more planet gears 6 can be
provided. The sun gear shaft 3 can operate as the "sun gear" of the
planetary system. The sun gear portion 3a of the sun gear 3 can be
operatively engaged with the planet gears 6 such that the planet
gears 6 are operatively meshed with the sun gear portion 3a, as
shown in FIG. 13 for the purpose of illustration and not
limitation. The ring gear 7 can operate as the "ring gear" of the
planetary system. The ring gear portion 7b can be operatively
engaged with the planet gears 6 such that the planet gears 6 are
operatively meshed with the ring gear portion 7b of the ring gear
7, as shown in FIG. 14 for the purpose of illustration and not
limitation. The step portion 3d of the sun gear shaft 3 can be
configured to maintain the position of the remaining portion the
planetary gear system. For example, the step portion 3d can engage
the ring gear 7 and reduce undesired movement of the ring gear 7,
which can reduce undesired movement of the planet gears 6.
[0137] As further depicted, the shuttle frame 9 (FIG. 9) can
include a clutch engagement portion 9a, a cavity 9b which can be
configured to receive a ferrule coupled to the proximal end of the
outer tubular member 22, and a guide 9c.
[0138] The second clutch driver 4b can be configured to
uni-directionally lock the sun gear shaft 3 and the planet carrier
5. As such, the sun gear shaft 3, planet carrier 5, and ring gear 7
have a 1:1 ratio of rotation during deployment of the trigger 60
from the first position to the second position. For example, the
sun gear engagement portion 4c of the second clutch driver 4b can
engage the clutch engagement portion 3c of the sun gear shaft 3,
such that the sun gear shaft 3 and the second clutch driver 4b
rotate together, as shown in FIG. 15, for the purpose of
illustration and not limitation. Additionally, the clutch portion
4d of the second clutch driver 4b can have a ratchet-like
engagement with the clutch component 5b of the planet carrier 5, as
shown in FIG. 16, for the purpose of illustration and not
limitation. Such a configuration can allow the sun gear shaft 3 and
planet carrier 5 to rotate independently of one another in a first
direction (e.g., when the planet carrier 5 rotates in the counter
clockwise direction in FIG. 16), and locked together in a second
direction (e.g., when the planet carrier 5 rotates in the clockwise
direction in FIG. 16).
[0139] The first clutch driver 4a can be configured to limit the
sun gear shaft 3 to uni-direction rotational motion. The first
clutch driver 4a and sun gear shaft 3 can be configured such that
the sun gear shaft 3 does not rotate during return of the trigger
from the second position to the first position. For example, the
sun gear engagement portion 4c of the first clutch driver 4a can be
fixedly engaged with the clutch engagement portion 3c of the sun
gear shaft 3, such that the sun gear shaft 3 and the first clutch
driver 4a rotate together, as shown in FIG. 15, for the purpose of
illustration and not limitation. Additionally, the first clutch
driver 4a can have a ratchet-type engagement with a separate
element, for example and as shown in FIG. 17 for the purpose of
illustration and not limitation, a clutch engagement portion 9a on
the shuttle frame 9. As such, the first clutch driver 4a can be
limited to uni-direction motion by the clutch engagement portion
9a, and thereby limit the sun gear shaft 3 to uni-directional
motion (e.g., the sun gear shaft 3 can only rotate in the
counterclockwise direct in FIG. 17).
[0140] The sun gear shaft 3 can be functionally coupled to the
outer tubular member 22 such that upon deployment of the trigger
from the first position to the second position, the sun gear shaft
3 rotates and thereby causes the outer tubular member 22 to move
proximally. For example, the shuttle frame 9 can be fixedly coupled
to the outer tubular member 22 at the cavity 9b. As depicted herein
for illustration, the shuttle frame 9 and outer tubular member 22
can be coupled by a ferrule. The sheath pinion portion 3b of the
sun gear shaft 3 can be functionally coupled to the handle 1 such
that upon deployment of the trigger 60 from the first position to
the second position the sun gear shaft 3 rotates, engages the
handle 1, and moves the shuttle frame 9 proximally a distance
relative to the handle 1. As such and as embodied herein the outer
tubular member 22 also moves proximally relative to the handle 1
because it is fixedly coupled to the shuttle frame 9. Additionally,
intermediate gear 10 can be functionally meshed between the sheath
pinion potion 3b and a sheath rack 1c disposed on the handle 1, as
shown in FIG. 18, for the purpose of illustration and not
limitation. Additionally or alternatively, the sheath pinion
portion 3b can directly mesh the sheath rack 1c. As noted herein
above, the first clutch driver 4b can prevent the sun gear shaft 3
from rotating during return of the trigger 60 from the second
position to the first position. Accordingly, the shuttle frame 9,
the outer tubular member 22 fixedly coupled thereto, and all other
components carried by the shuttle frame 9, will move proximally
when the trigger 60 is deployed from the first position to the
second position, but remain stationary when the trigger 60 is
returned from the second position to the first position as embodied
herein. The gears of the small spur gear 10b of the intermediate
gear 10 (or the gears of the sheath pinion portion 3b) and the
gears of the sheath rack 1c can utilize a non-standard pitch as
desired or needed. As an example and not by way of limitation, a
standard 48 pitch can be slightly enlarged. Such a change can allow
the actuation assembly to achieve the desired value of (d) when the
trigger 60 is deployed from the first position to the second
position.
[0141] The actuation assembly 2 can also include a ratchet rack 8.
The ratchet rack 8 can be fixedly coupled to the inner shaft member
21 and can be disposed on the shuttle frame 9, as shown in FIG. 19
for the purpose of illustration and not limitation. The ratchet
rack 8 can be operatively engaged with the ring gear 7. For
example, the ratchet rack 8 can be operatively meshed with the
circumferential pinion 7a of the ring gear 7, as shown in FIG. 20,
for the purpose of illustration and not limitation. Upon deployment
of the trigger 60 from the first position to the second position,
the ring gear 7 can rotate and cause the ratchet rack 8, and
therefore the inner shaft member 21, to move distally relative to
the handle. Upon return of the trigger 60 from the second position
to the first position, the ring gear 7 can rotate in the opposite
direction and cause the ratchet rack 8, and therefore the inner
shaft member 21, to move proximally relative to the handle.
[0142] The actuation assembly 2 can further include a plate 14
disposed on the shuttle assembly 9. The plate 14 can hold portions
of the actuation assembly 2 in place and can protect the actuation
assembly 2. The actuation assembly 2 can also include at least one
pin 13 configured to engage at least one pin track disposed within
the handle 1 to thereby guide the shuttle frame 9 along the handle,
as shown in FIG. 21 for the purpose of illustration and not
limitation. A pin track can be on the first side of the handle
housing 1a, the second side of the handle housing 1b, or on both
sides of handle 1. The at least one pin can include a first pin 13a
disposed through an axis of the sun gear shaft 3. The actuation
assembly can include additional pins, such as a second pin 13b and
a third pin 13c (FIG. 2), each disposed through the plate 14 and
the shuttle frame 9. The second pin 13b and third pin 13c can hold
the plate 14 in place on the shuttle frame 9. The actuation
assembly 2 can include a fourth pin 13d disposed through an axis of
the intermediate gear 10. The fourth pin 13d can engage the handle
and act as a guide as the shuttle frame 9 moves relative to the
handle 1.
[0143] In accordance with another aspect of the disclosed subject
matter, the actuation assembly 2 can be functionally coupled to the
trigger 60 by a driving rack 12. For example, the driving rack 12
can be fixedly coupled or releasably coupled to an intermediate
element functionally disposed between the driving rack 12 and the
trigger 60. As an example and not by way of limitation, the driving
rack 12 can have a bayonet-type engagement with the intermediate
element. The driving rack 12 can be operatively engaged with the
planet carrier 5. For example, the driving rack 12 can be
operatively meshed with the circumferential pinion 5a of the planet
carrier 5, as shown in FIG. 22 for the purpose of illustration and
not limitation. The driving rack 12 can be supported in a guide 9c
disposed on the shuttle 9, as shown in FIG. 22 for the purpose of
illustration and not limitation. Such a configuration can allow a
limited region of contact between the driving rack 12 and the
corresponding support surface, thereby reducing friction.
Additionally, such a configuration can provide support proximal to
the point of contact between the driving rack 12 and the planet
carrier 5, even as that point moves along the length of the driving
rack 12. In operation, upon deployment of the trigger 60 from the
first position to the second position, the driving rack 12 can move
distally, relative to the handle 1, and cause the planet carrier 5
to rotate in a first direction. Upon return of the trigger 60 from
the second position to the first position, the driving rack 12 can
move proximally relative to the handle, and cause the planet
carrier 5 to rotate in an opposite direction.
[0144] In view of the disclosed subject matter, the dimensions and
features of the trigger stop 67, shuttle 9 and elements disposed
thereon, sheath rack 1c, and the handle guide can be designed based
on the specifics of the implant 23, for example, the diameter of
the implant 23. As an example and not by way of limitation, for a
given radius of the intermediate gear 10, the sheath rack 1c and
the handle guide, can be a specific distance apart to properly
engage the small spur gear 10b of the intermediate gear 10 and the
pin 13d disposed through the axis of the intermediate gear 10. If
the radius of the intermediate gear is changed, the distance
between the sheath rack 1c and the handle guide can also be
adjusted accordingly.
[0145] For purpose of illustration, reference is now made to the
operation of the system with the actuation assembly disclosed
herein. During operation, the user can deploy the trigger 60 from
the first position to the second position (referred to herein as
the "first action"). The trigger 60 thus can cause the driving rack
12 to move in the distal direction. The driving rack 12,
functionally meshed with the circumferential pinion 5a of the
planet carrier 5, can impart rotational motion on the planet
carrier 5. The planet carrier 5 can impart rotational motion on the
three planet gears 6. The planet gears 6 can be constrained from
rotating freely because they are meshed with the sun gear portion
3a of the sun gear shaft 3. The three planet gears 6 can be meshed
with the ring gear portion 7b of the ring gear 7, and can impart
rotational motion on the ring gear 7. The ring gear 7, can be
operatively meshed with the ratchet rack 8, and can drive the
ratchet rack 8 distally. The inner shaft member 21, which can be
fixedly coupled to the ratchet rack 8, moves distally. The planet
carrier 5 can be rotationally coupled to the sun gear shaft 3 by
the second clutch driver 4b when rotating in the first action;
thus, rotation can be transmitted to the sun gear shaft 3 in a 1:1
ratio. The first clutch driver 4a allows the sun gear shaft 3 to
rotate freely relative to the shuttle frame 9 during the first
action. The sheath pinion 3b of the sun gear shaft 3 can be meshed
with the large spur gear 10a of the intermediate gear 10, and can
impart rotational motion on the intermediate gear 10. The small
spur gear 10b of the intermediate gear 10 can be operatively meshed
with a rack 1c disposed on the second handle housing portion 1b;
thus, the rotational motion of the intermediate gear 10 can impart
linear motion on the shuttle frame 9 in the proximal direction. The
outer tubular member 22, which can be fixedly coupled to the
shuttle frame 9 can move proximally relative to the handle. Thus,
during the first action, the inner shaft member 21 can move
distally relative to the handle 1 and the outer tubular member 22
can move proximally relative to the handle 1.
[0146] Upon return of the trigger 60 from the second position to
the first position (herein referred to as the "second action"), the
driving rack 12 can move proximally relative to the handle 1. The
driving rack 12 can impart rotational motion to the planet carrier
5. The planet carrier 5 can transmit rotational motion to the three
planet gears 6. The planet gears 6 can rotate about the sun gear
shaft 3, which can be held stationary relative the shuttle frame 9
via the first clutch driver 4a. The planet gears 6 can impart
rotary motion to the ring gear 7. The ratio of motion between the
planet carrier 5 and the ring gear 7 can be determined by the ratio
of ring gear portion 7b teeth to sun gear portion 3a teeth
(ratio=R/(R+S)). Linear motion can be transmitted to the ratchet
rack 8 in the proximal direction by the ring gear 7. The inner
shaft member 21 can move proximally relative to the handle 1. Thus,
during the second action, the inner shaft member moves proximally
relative to the handle 1 and the outer tubular member 22 is
stationary relative to the handle.
[0147] As further embodied herein, the actuation assembly 2 can
include a clutch release 11. The clutch release 11 can be
operatively coupled to the second clutch driver 4b and can be
configured to prevent the second clutch driver 4b from
uni-directionally locking the sun gear shaft 3 and the planet
carrier 5 when the clutch release 11 is engaged by a stop 1d. For
example, the clutch release 11 can prevent the clutch portion of
the second clutch driver 4b from engaging with the clutch component
5b of the planet carrier 5 by urging elements of the clutch portion
away from the clutch component 5b, as shown in FIG. 23, for the
purpose of illustration and not limitation. Thus, the clutch
release 11 can prevent the sun gear shaft 3, planet carrier 5 and
ring gear 7 rotating with a 1:1 ratio during the first motion.
Rather, when the clutch release 11 is engaged by the stop 1d, the
ratio of motion between planet carrier 5 and the ring gear 7 is the
same for the first motion and the second motion. The stop 1d can be
disposed on the handle 1, for example on the second handle housing
portion 1b. The stop 1d can be configured to engage the clutch
release 11 when the actuation assembly 2 has moved proximally a
distance (z) along the handle 1. Any suitable distances for (z) can
be used. The stop 1d can be inserted into a receiving pocket
disposed on the handle or otherwise secured with known techniques.
The clutch release 11 can include a saw-tooth portion 11a or other
suitable configuration, and the stop 1d can include a resilient
abutment portion. The saw-tooth portion of the clutch 11 thus can
be configured to engage the resilient abutment portion of the stop
1d. As an example, the stop can be P-shaped stop that can provide
compliance and opposing bias when the resilient abutment portion of
the stop 1d engages the saw-tooth portion of the clutch 11. Such a
configuration can prevent or inhibit disengagement of the clutch
release 11 and the clutch component 5b of the planet carrier 5.
[0148] Referring now to FIG. 24 for the purpose of illustration and
not limitation, another exemplary embodiment of a system for
delivering an implant is provided and designated generally by
reference character 1001. Portions of this exemplary embodiment are
depicted in FIGS. 25-35. Elements that are similar to the
previously described embodiment have been given like numbers. The
delivery system 1001 can be configured to deliver an implant in a
similar manner as described herein above.
[0149] The delivery system 1001 can include a handle 101, an outer
tubular member 122, an inner shaft member 121, and an implant 123,
for example, a braided implant. The handle 101 can include a
trigger 160 and an actuation assembly 102, which can be configured
to move the inner shaft member 121 and the outer tubular member 122
relative to the handle 101 as described above upon deployment of
the trigger 160 from the first position to the second position and
return from the second position to the first position. The trigger
160 can include a lock as described herein above.
[0150] Referring now to FIGS. 25-35 for the purpose of illustration
and not limitation, the actuation assembly 102 can include a
planetary gear system. For purpose of illustration and not
limitation, the actuation assembly 102 can be suitably similar to
that of the previous embodiment. However, as an alternative to the
actuation assembly of the previous embodiment, certain
modifications can be incorporated. For example, the ratchet rack
108 can be operatively meshed with the planet carrier 105, and the
driving rack 112 can be operatively meshed with the ring gear
107.
[0151] The actuation assembly 102 can include a sun gear shaft 103
(which can include a sun gear portion 103a, a sheath pinion 103b,
and a clutch engagement portion 103c; FIG. 27), a planet carrier
105 (which can include a circumferential pinion 105a, a clutch
component 105b, and at least one pin 105c; FIG. 28), at least one
planet gear 106, a ring gear 107 (which can include a
circumferential pinion 107a and a ring gear portion 107b; FIG. 29),
a first clutch driver 104a and a second clutch driver 104b, both
identical in shape (each can include a sun gear shaft engagement
portion 104c and a clutch portion 104d; FIG. 30). The actuation
assembly 102 can include a shuttle frame 109. The shuttle frame 109
can have the planet carrier 105, planet gears 106, sun gear shaft
103, ring gear 107, and first and second clutch drivers (104a and
104b) disposed thereon. The shuttle frame 109 can be disposed
within the handle 101 and can be moveable relative to the handle
101 along the length of the handle 101. The shuttle frame 109 can
include a clutch engagement portion 109a, a cavity 109b which can
receive a ferrule coupled to the proximal end of the outer tubular
member 122, and clips 109d and 109e, which can hold the planetary
gear system in place on the shuttle frame 109. The planet carrier
105, planet gears 106, sun gear shaft 103 and ring gear 107 can
perform as the respective elements of the planetary gear system as
described above. The actuation assembly can also include a ratchet
rack 108. The actuation assembly can be functionally coupled to the
trigger 160 by a driving rack 112, which can be supported by the
handle 101. The actuation assembly can include a clutch release 111
which can engage a stop 101d disposed on the handle, as described
herein above with regard to system 1000.
[0152] During operation, the user can deploy the trigger 160 from
the first position to the second position (referred to herein as
the "first action"). The trigger 160 can cause the driving rack 112
to move in a proximal direction. The driving rack 112, functionally
meshed with the circumferential pinion 107a of the ring gear 107,
can impart rotational motion on the ring gear 107 (FIG. 34). The
ring gear portion 107b of the ring gear 107 can be operatively
meshed with the planet gears 106, and can impart rotational motion
on the planet gears 106. The planet gears 106 are operatively
meshed with the sun gear portion 103a of the sun gear shaft 103 and
thus can be constrained from rotating freely because they. The
movement of the planet gears 106, which are disposed on the pins
105c of the planet carrier 105, can impart rotational motion on the
planet carrier 105. The planet carrier 105 and the sun gear shaft
103 can be rotationally coupled by the second clutch driver 104b
when rotating in the first action; thus, rotation can be
transmitted to the sun gear shaft 103 in a 1:1 ratio. The first
clutch driver 104a can allow the sun gear shaft 103 to rotate
freely relative to the shuttle frame 109 during the first action.
The sheath pinion 103b of the sun gear shaft 103 can be meshed with
the large spur gear 110a of an intermediate gear 110, and can
impart rotational motion on the intermediate gear 110. The small
spur gear 110b of the intermediate gear 110 can be operatively
meshed with a rack 101c disposed on the second handle housing
portion 101b; thus, the rotational motion of the intermediate gear
110 can impart linear motion on the shuttle frame 109 in the
proximal direction. The outer tubular member 122, which can be
fixedly coupled to the shuttle frame 109, can move proximally
relative to the handle 101. The circumferential pinion 105a of the
planet carrier 105 can be operatively meshed with a ratchet rack
108, and rotation of the planet carrier 105 can move the ratchet
rack 108 distally (FIG. 35). The inner shaft member 121, which can
be fixedly coupled to the ratchet rack 108, moves distally. Thus,
during the first action, the inner shaft member 121 can move
distally relative to the handle 101 and the outer tubular member
122 can move proximally relative to the handle 101.
[0153] Upon return of the trigger 160 from the second position to
the first position (herein referred to as the "second action"), the
driving rack 112 can move distally relative to the handle 101. The
driving rack 112 can impart rotational motion on the ring gear 107.
The ring gear 107 can impart rotational motion on the three planet
gears 106. The planet gears 106 can rotate about the sun gear shaft
103, which can be held stationary relative the shuttle frame 109
via the first clutch driver 104a. The planet gears 106 can impart
rotational motion on the planet carrier 105. Linear motion in the
proximal direction can be transmitted to the ratchet rack 108 by
the planet carrier 105. The inner shaft member 121, fixedly coupled
to the ratchet rack 108, can move proximally relative to the handle
101. Thus, during the second action, the inner shaft member 121 can
move proximally relative to the handle 101 and the outer tubular
member 122 can be stationary relative to the handle 101.
[0154] Referring to FIG. 36 for the purpose of illustration and not
limitation, an exemplary embodiment of a system for delivering an
implant is provided and designated generally by reference character
1002. Portions of this exemplary embodiment are depicted in FIGS.
37-45. Elements that are similar to the previously described
embodiments have been given like numbers, and unless described
otherwise, the element can include the same features as described
above. The delivery system 1002 can be configured to deliver an
implant in a similar manner as described hereinabove.
[0155] The delivery system 1002 can include a handle 201, an outer
tubular member 222, an inner shaft member 221, and an implant 223,
for example, a braided implant. The handle 201 can include a
trigger 260 and an actuation assembly 202, which can be configured
to move the inner shaft member 221 and the outer tubular member 222
relative to the handle 201 as described above upon deployment of
the trigger 260 from the first position to the second position and
return from the second position to the first position. The trigger
260 can include a lock as described herein above.
[0156] Referring now to FIGS. 37-45 for the purpose of illustration
and not limitation, the actuation assembly 202 can include a
planetary gear system as embodied in delivery system 1001. For
example, the actuation assembly 202 can include a sun gear shaft
203 (which can include a sun gear portion 203a, a sheath pinion
203b, and a clutch engagement portion 203c; FIG. 39), a planet
carrier 205 (which can include a circumferential pinion 205a, a
clutch component 205b, and at least one pin 205c; FIG. 40), at
least one planet gear 206, a ring gear 207 (which can include a
circumferential pinion 207a and a ring gear portion 207b; FIG. 41),
a first clutch driver 204a and a second clutch driver 204b, both
identical in shape (each can include sun gear shaft engagement
portion 204c and a clutch portion 204d; FIG. 42). The actuation
assembly 202 can include a shuttle frame 209. The shuttle frame 209
can have the planet carrier 205, planet gears 206, sun gear shaft
203, ring gear 207, and first and second clutch drivers (204a and
204b) disposed thereon. The shuttle frame 209 can be disposed
within the handle 201 and can be moveable relative to the handle
201 along the length of the handle 201. The shuttle frame 209 can
include a clutch engagement portion 209a, a cavity 209b which can
receive a ferrule coupled to the proximal end of the outer tubular
member 222, and clips 209d and 209e, which can hold the planetary
gear system in place on the shuttle frame 209. The planet carrier
205, planet gears 206, sun gear shaft 203 and ring gear 207 can
perform as the respective elements of the planetary gear system as
described above. The actuation assembly can also include a ratchet
rack 208. The actuation assembly can be functionally coupled to the
trigger 260 by a driving rack 212, which can be supported by the
handle 201. The actuation assembly can include a clutch release 211
which can engage a stop 201d disposed on the handle, as described
herein above with regard to system 1000.
[0157] During operation, the user can deploy the trigger 260 from
the first position to the second position (referred to herein as
the "first action"). The trigger 260 can cause the driving rack 212
to move in a proximal direction. The driving rack 212, functionally
meshed with the circumferential pinion 207a of the ring gear 207,
can impart rotational motion on the ring gear 207. The ring gear
portion 207b of the ring gear 207 can be operatively meshed with
the planet gears 106, and can impart rotational motion on the
planet gears 206. The planet gears 206 can be constrained from
rotating freely because they are operatively meshed with the sun
gear portion 203a of the sun gear shaft 203. The movement of the
planet gears 206, which are disposed on the pins 205c of the planet
carrier 205, can impart rotational motion on the planet carrier
205. The planet carrier 205 and the sun gear shaft 203 can be
rotationally coupled by the second clutch driver 204b when rotating
in the first action; thus, rotation can be transmitted to the sun
gear shaft 203 in a 1:1 ratio. The first clutch driver 204a can
allow the sun gear shaft 203 to rotate freely relative to the
shuttle frame 209 during the first action. The sheath pinion 203b
of the sun gear shaft 203 can be meshed with the large spur gear
210a of an intermediate gear 210, and can impart rotational motion
on the intermediate gear 210. The small spur gear 210b of the
intermediate gear 210 can be operatively meshed with a rack 201c
disposed on the second handle housing portion 201b; thus, the
rotational motion of the intermediate gear 210 can impart linear
motion on the shuttle frame 209 in the proximal direction. The
outer tubular member 222, which can be fixedly coupled to the
shuttle frame 209 can move proximally relative to the handle 201.
The circumferential pinion 205a of the planet carrier 205 can be
operatively meshed with a ratchet rack 208, and rotation of the
planet carrier 205 can move the ratchet rack 208 distally. The
inner shaft member 221, which can be fixedly coupled to the ratchet
rack 208, moves distally. Thus, during the first action, the inner
shaft member 221 can move distally relative to the handle 201 and
the outer tubular member 222 can move proximally relative to the
handle 101.
[0158] Upon return of the trigger 260 from the second position to
the first position (herein referred to as the "second action"), the
driving rack 212 can move distally relative to the handle 201. The
driving rack 212 can impart rotational motion on the ring gear 207.
The ring gear 207 can impart rotational motion on the three planet
gears 206. The planet gears 206 can rotate about the sun gear shaft
203, which can be held stationary relative the shuttle frame 209
via the first clutch driver 204a. The planet gears 106 can impart
rotational motion on the planet carrier 205. Linear motion in the
proximal direction can be transmitted to the ratchet rack 208 by
the planet carrier 205. The inner shaft member 221, fixedly coupled
to the ratchet rack 208, can move proximally relative to the handle
201. Thus, during the second action, the inner shaft member 221 can
move proximally relative to the handle 201 and the outer tubular
member 222 can be stationary relative to the handle 201.
[0159] Referring to FIG. 46 for the purpose of illustration and not
limitation, an exemplary embodiment of a system for delivering an
implant is provided and designated generally by reference character
1003. Portion of this exemplary embodiment are depicted in FIGS.
47-51. Elements that are similar to the previously described
embodiments have been given like number, and unless described
otherwise, the elements can include the same features as described
above.
[0160] The delivery system 1003 can include a handle 301, an outer
tubular member 322, an inner shaft member 321, and an implant 323,
for example, a braided implant. The handle 301 can include a
trigger 360 and an actuation assembly 302, which can be configured
to move the inner shaft member 321 and the outer tubular member 322
relative to the handle 301 as described above upon deployment of
the trigger 360 from the first position to the second position and
return from the second position to the first position. The trigger
360 can include a lock as described herein above.
[0161] Referring now to FIGS. 47-51 for the purpose of illustration
and not limitation, the actuation assembly 302 can include a
planetary gear system as embodied in delivery system 1001. For
example, the actuation assembly 302 can include a sun gear shaft
303 (which can include a sun gear portion 303a, a sheath pinion
303b, and a clutch engagement portion 303c; FIG. 47), a planet
carrier 305 (which can include a circumferential pinion 305a, a
clutch component 305b, and a least one pin 305c; FIG. 48), at least
one planet gear 306, a ring gear 307 (which can include a
circumferential pinion 307a and a ring gear portion 307b; FIG. 49),
a first clutch driver 304a and a second clutch driver 304b, both
identical in shape (each can include including a sun gear shaft
engagement portion 304c and a clutch portion 304d; FIG. 50). The
actuation assembly 302 can include a shuttle frame 309. The shuttle
frame 309 can have the planet carrier 305, planet gears 306, sun
gear shaft 303, ring gear 307, and first and second clutch drivers
304a, 304b disposed thereon. The shuttle frame 309 can be disposed
within the handle 301 and can be moveable relative to the handle
301 along the length of the handle 301. The shuttle frame 309 can
include clips 309d and 309e, which can hold the planetary gear
system in place on the shuttle frame 309. The planet carrier 305,
planet gears 306, sun gear shaft 303, and ring gear 307 can perform
as the respective elements of the planetary gear system as
described above. The actuation assembly can also include a ratchet
rack 308. The actuation assembly can be functionally coupled to the
trigger 360 by a driving rack 312, which can be supported by the
handle 301.
[0162] During operation, the user can deploy the trigger 360 from
the first position to the second position (referred to herein as
the "first action"). The trigger 360 can cause the driving rack 312
to move in a proximal direction. The driving rack 312, functionally
meshed with the circumferential pinion 307a of the ring gear 307,
can impart rotational motion on the ring gear 307. The ring gear
portion 307b of the ring gear 307 can be operatively meshed with
the planet gears 306, and can impart rotational motion on the
planet gears 306. The planet gears 306 can be constrained from
rotating freely because they are operatively meshed with the sun
gear portion 303a of the sun gear shaft 303. The movement of the
planet gears 306, which are disposed on the pins 305c of the planet
carrier 305, can impart rotational motion on the planet carrier
305. The planet carrier 305 and the sun gear shaft 303 are
rotationally coupled by the second clutch driver 304b when rotating
in the first action; thus, rotation can be transmitted to the sun
gear shaft 303 in a 1:1 ratio. The first clutch driver 304a allows
the sun gear shaft 303 to rotate freely relative to the shuttle
frame 309 during the first action. The sheath pinion 303b of the
sun gear shaft 303 can be meshed a rack 301c disposed on the second
handle housing portion 301b; thus, the rotational motion of the sun
gear shaft 303 can impart linear motion on the shuttle frame 309 in
the proximal direction. The outer tubular member 322, which can be
fixedly coupled to the shuttle frame 309 can move proximally
relative to the handle 301. The circumferential pinion 305a of the
planet carrier 305 can be operatively meshed with a ratchet rack
308, and rotation of the planet carrier 305 can move the ratchet
rack 308 distally. The inner shaft member 321, which can be fixedly
coupled to the ratchet rack 308, moves distally. Thus, during the
first action, the inner shaft member 321 can move distally relative
to the handle 301 and the outer tubular member 322 can move
proximally relative to the handle 301.
[0163] Upon return of the trigger 360 from the second position to
the first position (herein referred to as the "second action"), the
driving rack 312 can move distally relative to the handle 301. The
driving rack 312 can impart rotational motion on the ring gear 307.
The ring gear 307 can impart rotational motion on the three planet
gears 306. The planet gears 306 can rotate about the sun gear shaft
303, which can be held stationary relative the shuttle frame 309
via the first clutch driver 304a. The planet gears 306 can impart
rotational motion on the planet carrier 305. Linear motion can be
transmitted to the ratchet rack 308 by the planet carrier 305. The
inner shaft member 321 can move proximally relative to the handle
301. Thus, during the second action, the inner shaft member 321 can
move proximally relative to the handle 301 and the outer tubular
member 322 can be stationary relative to the handle 301.
[0164] Referring now to FIG. 52 for the purpose of illustration and
not limitation, an exemplary embodiment of a system for delivering
an implant is provided and designated generally by reference
character 1004. Portions of this exemplary embodiment are depicted
in FIGS. 53-61. Elements that are similar to the previously
described embodiment have been given like numbers. The delivery
system 1004 can be configured to deliver an implant in a similar
manner as described herein above.
[0165] The delivery system 1004 can include a handle 401, an outer
tubular member 422, an inner shaft member 421, and an implant 423,
for example, a braided implant. The handle 401 can include a
trigger 460 and an actuation assembly 402, which can be configured
to move the inner shaft member 421 and the outer tubular member 422
relative to the handle 401 as described above upon deployment of
the trigger 460 from the first position to the second position and
return from the second position to the first position. The trigger
460 can include a lock as described herein above.
[0166] Referring now to FIGS. 53-61 for the purpose of illustration
and not limitation, the actuation assembly 402 can include a
planetary gear system as embodied in delivery system 1000. For
example, the actuation assembly 402 can include a sun gear shaft
403 (which can include a sun gear portion 403a, a sheath pinion
403b, and a clutch engagement portion 403c; FIG. 55), a planet
carrier 405 (which can include a circumferential pinion 405a, a
clutch component 405b, and at least one pin 405c; FIG. 56), at
least one planet gear 406, a ring gear 407 (which can include a
circumferential pinion 407a and a ring gear portion 407b; FIG. 57),
a first clutch driver 404a and a second clutch driver 404b, both
identical in shape (each can include including a sun gear shaft
engagement portion 404c and a clutch portion 404d; FIG. 58). The
actuation assembly 402 can include a shuttle frame 409. The shuttle
frame 409 can have the planet carrier 405, planet gears 406, sun
gear shaft 403, ring gear 407, and first and second clutch drivers
(404a and 404b) disposed thereon. The shuttle frame 409 can be
disposed within the handle 401 and can be moveable relative to the
handle 401 along the length of the handle 401. The shuttle frame
409 can include a clutch engagement portion 409a, a cavity 409b
which can receive a ferrule coupled to the proximal end of the
outer tubular member 422, and a guide 409c. The actuation assembly
402, can include a plate 414 disposed on the shuttle assembly 409.
The plate 414 can hold portions of the actuation assembly 402 in
place and can protect the actuation assembly 402. The actuation
assembly 402 can include at least one pin 413 configured to engage
at least one pin track disposed within the handle 401 to thereby
guide the shuttle frame 409 along the handle. The at least one pin
can include a first pin 413a disposed through an axis of the sun
gear shaft 403. The actuation assembly can include a second pin
413b and a third pin 413c, each disposed through the plate 414 and
the shuttle frame 409. The second pin 413b and third pin 413c can
hold the plate 414 in place on the shuttle frame 409. The actuation
assembly 402 can include a fourth pin 413d disposed through an axis
of the intermediate gear 410. The fourth pin 413d can engage the
handle to guide the actuation assembly 402 as it moves relative to
the handle 401. The actuation assembly can be functionally coupled
to the trigger 460 by a driving rack 412, which can be supported in
the guide 409c. The actuation assembly can include a clutch release
411 which can engage a stop 401d disposed on the handle, as
described herein above with regard to system 1000.
[0167] During operation, the user can deploy the trigger 460 from
the first position to the second position (referred to herein as
the "first action"). The trigger 640 can cause the driving rack 412
to move in the distal direction. The driving rack 412, functionally
meshed with the circumferential pinion 405a of the planet carrier
405, can impart rotational motion on the planet carrier 405. The
planet carrier 405 can impart rotational motion on the three planet
gears 406. The planet gears 406 can be constrained from rotating
freely because they can be meshed with the sun gear portion 403a of
the sun gear shaft 403. The three planet gears 406 can be meshed
with the ring gear portion 407b of the ring gear 407, and can
impart rotational motion on the ring gear 407. The ring gear 407,
which can be meshed with the ratchet rack 408, and can drive the
ratchet rack 408 distally. The inner shaft member 421, which can be
fixedly coupled to the ratchet rack 408, moves distally. The planet
carrier 405 can be rotationally coupled to the sun gear shaft 403
by the second clutch driver 404b when rotating in the first action;
thus, rotation can be transmitted to the sun gear shaft 403 in a
1:1 ratio. The first clutch driver 404a can allow the sun gear
shaft 403 to rotate freely relative to the shuttle frame 409 during
the first action. The sheath pinion 403b of the sun gear shaft 403
can be meshed with the large spur gear 410a of the intermediate
gear 410, and can impart rotational motion on the intermediate gear
410. The small spur gear 410b of the intermediate gear 410 can be
operatively meshed with a rack 401c disposed on the second handle
housing portion 401b; thus, the rotational motion of the
intermediate gear 410 can impart linear motion on the shuttle frame
409 in the proximal direction. The outer tubular member 422, which
can be fixedly coupled to the shuttle frame 409, can move
proximally relative to the handle. Thus, during the first action,
the inner shaft member 421 can move distally relative to the handle
401 and the outer tubular member 422 can move proximally relative
to the handle 401.
[0168] Upon return of the trigger 460 from the second position to
the first position (herein referred to as the "second action"), the
driving rack 412 can move proximally relative to the handle 401.
The driving rack 412 can impart rotational motion to the planet
carrier 405. The planet carrier 405 can transmit rotational motion
to the three planet gears 406. The planet gears 406 can rotate
about the sun gear shaft 403, which can be held stationary relative
the shuttle frame 409 via the first clutch driver 404a. The planet
gears 406 can impart rotary motion to the ring gear 407. Linear
motion can be transmitted to the ratchet rack 408 in the proximal
direction by the ring gear 407. The inner shaft member 421, which
can be fixedly coupled to the ratchet rack 408, can move proximally
relative to the handle 401. Thus, during the second action, the
inner shaft member moves proximally relative to the handle 401 and
the outer tubular member 422 can be stationary relative to the
handle.
[0169] Referring to FIG. 62 for the purpose of illustration and not
limitation, an exemplary embodiment of a system for delivering an
implant is provided and designated generally by reference character
1005. Portions of this exemplary embodiment are depicted in FIGS.
63-75. Elements that are similar to the previously described
embodiment have been given like numbers. The delivery system 1005
can be configured to deliver an implant in a similar manner as
described herein above.
[0170] The delivery system 1005 can include a handle 501, an outer
tubular member 522, an inner shaft member 521, and an implant 523,
for example, a braided implant. The handle 501 can include a
trigger 560 and an actuation assembly 502, which can be configured
to move the inner shaft member 521 and the outer tubular member 522
relative to the handle 501 as described above upon deployment of
the trigger 560 from the first position to the second position and
return from the second position to the first position. The trigger
560 can include a lock as described herein above.
[0171] Referring now to FIGS. 63-75 for the purpose of illustration
and not limitation, the actuation assembly 502 can include a
planetary gear system similar to the planetary gear system
disclosed in system 1000. In lieu of a shuttle frame and a ratchet
rack coupled to the outer tubular member and inner shaft member,
respectively, the system 1005 can include gondolas disposed on
tension elements, as described further below.
[0172] For example, the actuation assembly 502 can include a sun
gear shaft 503 (which can include a sun gear portion 503a, a clutch
engagement portion 503c, and a sheath gear engagement portion 503d;
FIG. 65), a planet carrier 505 (which can include a circumferential
pinion 505a, a clutch component 505b, and at least one pin 505c;
FIG. 66), at least one planet gear 456, a ring gear 507 (which can
include a circumferential pinion 507a and a ring gear portion 507b;
FIG. 67), a first clutch driver 404a and a second clutch driver
404b, both identical in shape (each can include including a sun
gear shaft engagement portion 504c and a clutch portion 504d; FIG.
68). The actuation assembly can include a sheath gear 524, which
can engage the sheath gear engagement portion 503d of the sun gear
shaft 503. The actuation assembly can include a first tension
element 525, and a sheath gondola 526 disposed on the first tension
element. The first tension element can be functionally coupled to
the sheath gear 524. The sheath gondola 526 can be fixedly coupled
to the outer tubular member 522. The actuation assembly can include
a second tension element 527, and a ratchet gondola 528 disposed on
the second tension element. The second tension element 527 can be
functionally coupled to the circumferential pinion 507a of the ring
gear 507. The ratchet gondola 528 can be fixedly attached the inner
shaft member 521. The actuation assembly can include a clutch ring
531, which can be fixedly placed within the handle 501 and can
provide a clutch engagement portion for the first clutch driver
501a. Alternatively, the handle 501 can include a clutch engagement
portion to engage the first clutch driver 501a. The system can
further include a plurality of pulley elements 529, which can be
used to guide the first and second tension elements, and at least
two tensioners 530a, 530b, which can be used to achieve the desired
tension in the first and second tension elements. The actuation
assembly can be functionally coupled to the trigger 560 by a
driving rack 512. The actuation assembly can include a clutch
release 511 which can engage a stop 501e disposed within the
handle, and configured to engage the clutch release 511 when the
sheath gondola has moved the stop 501e into place.
[0173] During operation, the user can deploy the trigger 560 from
the first position to the second position (referred to herein as
the "first action"). The trigger 540 can cause the driving rack 512
to move in the distal direction. The driving rack 512, functionally
meshed with the circumferential pinion 505a of the planet carrier
505, can impart rotational motion on the planet carrier 505. The
planet carrier 505 can impart rotational motion on the three planet
gears 506. The planet gears 506 can be constrained from rotating
freely because they can be meshed with the sun gear portion 503a of
the sun gear shaft 503. The three planet gears 506 can be meshed
with the ring gear portion 507b of the ring gear 507, and can
impart rotational motion on the ring gear 407. The ring gear 507,
which can be functionally coupled to the ratchet gondola 528 by the
second tension element 527, can cause the ratchet gondola 528 to
move distally. The inner shaft member 521, which can be fixedly
coupled to the ratchet gondola 528, can move distally. The planet
carrier 505 can be rotationally coupled to the sun gear shaft 503
by the second clutch driver 504b when rotating in the first action;
thus, rotation can be transmitted to the sun gear shaft 503 in a
1:1 ratio. The first clutch driver 504a can allow the sun gear
shaft 503 to rotate freely relative to the clutch ring 531 during
the first action. The sheath gear engagement portion 503d of the
sun gear shaft 503 can functionally engage the sheath gear 524, and
can impart rotational motion on sheath gear 524. The sheath gear
524, which can be functionally coupled to the sheath gondola 526 by
the first tension element 525, can cause the sheath gondola 526 to
move proximally. The outer tubular member 522, which can be fixedly
coupled to the sheath gondola 526, can move proximally relative to
the handle. Thus, during the first action, the inner shaft member
521 can move distally relative to the handle 501 and the outer
tubular member 522 can move proximally relative to the handle
501.
[0174] Upon return of the trigger 560 from the second position to
the first position (herein referred to as the "second action"), the
driving rack 512 can move proximally relative to the handle 501.
The driving rack 512 can impart rotational motion to the planet
carrier 505. The planet carrier 505 can transmit rotational motion
to the three planet gears 506. The planet gears 506 can rotate
about the sun gear shaft 503, which can be held stationary relative
the clutch ring 531 via the first clutch driver 504a. The planet
gears 506 can impart rotary motion to the ring gear 507. The ring
gear 507 can drive the ratchet gondola 528 proximally via the
second tension element 527. The inner shaft member 521, which can
be fixedly coupled to the ratchet gondola 528, can move proximally
relative to the handle 501. Thus, during the second action, the
inner shaft member can move proximally relative to the handle 501
and the outer tubular member 422 can be stationary relative to the
handle.
[0175] In accordance with the described subject matter, and as
noted above, a trigger assembly for a delivery system is also
provided. The trigger assembly includes a trigger functionally
connected to the actuation assembly by a driving rack, a gear train
functionally disposed between the trigger and the driving rack. The
gear train includes a trigger gear sector, a trigger pinion
operatively meshed with the trigger gear sector, a slide pinion
operatively coupled to the trigger pinion, and a slide rack
disposed on a slide coupled to the driving rack and operatively
meshed with the trigger pinion.
[0176] With regard to the trigger assembly, FIGS. 76-85 depict
portions of the delivery system 1000 described herein above. The
trigger 60 is operatively coupled to the handle and moveable
between a first position and a second position. Furthermore the
trigger can be biased towards the first and/or second position, for
example, by a spring 91 (FIG. 83). As described in further detail
below, the trigger assembly can further include a ratchet mechanism
80 which can prevent moving the trigger between the first and
second positions. Particularly, the ratchet can be configured to
require a full stroke of the trigger in one direction to allow
motion of the trigger in the opposite direction.
[0177] As embodied herein, and with reference to FIG. 2, the
trigger 60 can be coupled to the actuation assembly 2 by a driving
rack 12. For example, the trigger 60 can be functionally coupled to
the driving rack by gear train. The gear train can include a
trigger gear sector 63 (FIG. 77), a trigger pinion 64 (FIG. 78), a
slide pinion 65 (FIG. 79), a slide 61 (FIG. 80; sometimes referred
to as an intermediate element) having a slide rack 66, and a base
81 that can support certain elements of the gear train (FIG. 81).
The trigger 63 can be pivotally coupled to the base 81. The trigger
gear sector 63 can be coupled to the trigger 60, for example, the
trigger gear sector 63 can be unitary with the trigger 60, and can
be operatively meshed with the trigger pinion 64. The trigger
pinion 64 can be operatively coupled to the slide pinion 65. For
example, the trigger pinion 64 and the slide pinion 65 can be
coupled by splines and grooves, such as, four splines on the
trigger pinion 64 configured to be received by four grooves in the
slide pinion 65 as depicted in FIGS. 78 and 79. The slide pinion 65
can be operatively meshed with the slide rack 66 disposed on the
slide 61. The driving rack 12 can be coupled to the slide 61. The
driving rack 12 can be fixedly coupled or releasably coupled to the
slide 61. As an example and not by way of limitation, the driving
rack 12 can have a bayonet-type engagement with the slide 61.
Furthermore, more than one trigger gear sector and/or trigger
pinion can be provided, as shown, for example, in FIGS. 1-3, and
76, the gear train can include two trigger gear sectors 63 and two
trigger pinions 64. Each of the trigger pinions 64 can be coupled
to the slide pinion 65 as described above.
[0178] As embodied herein, the slide pinion 65 can be quad
symmetrical. For example, the slide pinion 65 can have 28 teeth
evenly distributed in sets of 7. The number of grooves can be a
factor of the number of teeth, for example, 4 grooves and 28 teeth.
Such a configuration can allow for symmetry between the teeth and
the grooves of the slide pinion 65, and thus ease of assembly
and/or use. Accordingly, when the slide pinion 65 is coupled the
trigger pinion 64, the teeth are in proper alignment. Additionally
or alternatively, the slide pinion 65 can include teeth around only
a portion of the circumference. For example, rather than including
teeth about the entire circumference, a number of teeth (e.g., 10
teeth) can be removed or omitted. This arrangement can accommodate
other elements, for example, the movement of spring 90 (described
in greater detail below) toward the slide pinion 65 during movement
of the trigger 60 when space is restricted. Furthermore, at least
one spline can be configured to align radially a selected location,
e.g., a missing tooth, so as to allow for self-alignment.
[0179] With reference to FIGS. 83 and 84, for the purpose of
illustration and limitation, a spring 90 can be provided. The
spring can be, for example, a torsion spring 90. Additional springs
can likewise be provided, e.g., two springs 90, as depicted in FIG.
76. The spring 90 can be coupled to the trigger such that energy is
stored in the spring 90 upon deployment of the trigger 60 from the
first position to the second position. The energy stored in the
spring 90 thus can be configured to bias the trigger 60 to return
from the second position to the first position. The spring 90 can
be housed within a spring support 91 (FIG. 84). The spring support
can be coupled to the trigger 60 and the base 81. The spring
support 91 can house the spring 90 such that energy is stored in
the spring 90 when the trigger 60 is in the first position, e.g.,
the spring support 91 can hold the spring 90 in a pre-loaded
position. Such a configuration can cause a force to be felt as the
user initially begins to move the trigger 60 from the first
position to the second position. Additionally, by providing such a
configuration, the spring can provide additional force or bias to
assist in returning the trigger 60 from the second position to the
first position, and thus ensure that the trigger 60 returns from
the second position to the first position.
[0180] The spring support 90 can be configured to house and/or
strengthen the spring, such as an exoskeleton arrangement. For
example, the spring support 90 can have legs configured to engage
the legs of the torsion spring 90, as depicted in FIG. 84. The legs
of the spring support 91 can be configured to move with the legs of
the torsion spring 90. If the spring includes a barrel portion, the
spring support 91 can also include a barrel portion to accommodate
the barrel portion of the spring 90. The spring support 91 can be a
single piece element, or can include several elements coupled
together to form the spring support (FIG. 84C). The elements when
assembled thus can be configured to allow the spring support to
move with the spring 90, but prevent the spring from fully
relaxing. The spring support 91 thus can reduce or prevent loads on
other elements of the delivery system, for example, the trigger 60
and the base 81, which can be plastic. That is, the spring support
91 can be made from metal or other suitably strong materials,
preferably such materials that are not susceptible to creep under
stress.
[0181] In accordance with another aspect of the disclosed subject
matter, the delivery system can include a ratchet mechanism. With
reference to FIG. 85, for the purpose of illustration and not
limitation, the system can include ratchet mechanism 80. The
ratchet mechanism 80 can include a first state and a second state.
The first state can be configured to allow the trigger 60 to move
toward the second position and prohibit motion toward the first
position. The second state can be configured to allow the trigger
60 to move toward the first position and prohibit motion toward the
second position. Such a system thus can be configured to require
the user to perform a full stroke of the trigger 60 between the
first and second position before allowing return movement in the
opposite direction.
[0182] The ratchet mechanism 80 can include a first pawl 82. The
first pawl 82 can be supported by a peg 86 coupled to the base 81.
The first pawl 82 can pivot relative the peg, and thus relative the
base 81. The first pawl 82 can also be coupled to one end of a
ratchet spring 87 (not shown for purpose of clarity), which can be
coupled to the base 81 at its opposite end. The ratchet mechanism
80 also can include a trigger ratchet rack 83 and the like. The
trigger ratchet rack 83 can be disposed on the slide 61. The
trigger ratchet rack 83 can be configured to engage the first pawl
82 to permit unidirectional motion of the slide 61. By limiting the
slide 61 to unidirectional motion, the trigger can likewise be
limited to unidirectional motion (i.e., toward the first state or
toward the second state). The first pawl 82 can have a first state
configured to allow the trigger 60 to move toward the second
position and prohibit motion toward the first position and a second
state configured to allow the trigger 60 to move toward the first
position and prohibit motion toward the second position. The
ratchet spring 87 can keep the pawl 82 biased toward the first
position or the second position, selectively. That is, the pawl 82
can be configured to switch from the first state to the second
state as the trigger approaches the second position from the first
position. Likewise, the pawl 82 can be configured to switch from
the second state to the first state as the trigger approaches the
first position from the second position. For example and not by way
of limitation, the trigger ratchet rack 83 can be configured to
move past the first pawl 83, as the trigger approaches either the
first position or the second position, respectively, and thus allow
the first pawl 82 to move freely to the alternate state due to the
bias of ratchet spring 87. As described herein, the pawl 83 can
engage the ratchet rack 83 in both the first position and the
second position. Additionally or alternatively, the ratchet
mechanism can be configured with more than one rack, for example a
dual rack, and the pawl 83 can engage a different rack in each
state. The pawl 82 can be moved out of the first or second position
to a third position (e.g., a defeated position) in which the pawl
82 does not engage the trigger ratchet rack 83. As an example, the
pawl 82 can be moved to the defeated position by moving the pawl 83
perpendicular to the trigger ratchet rack 83 along peg 86. The base
81 can include a defeat hole 81a (FIG. 81C), which can be aligned
with the pawl 82 and can be aligned with a similar defeat hole in
the handle 1, such that the pawl 82 can be defeated by pushing an
instrument through the defeat holes and urging the pawl 82 along
the peg 86. Peg 86 can be configured to prevent the pawl 82 from
returning to the first or second positions once the pawl has been
moved to the defeated position. For example and as shown in FIG.
85D, the peg 86 can have a variable diameter. The pawl 82 can be
disposed on the larger diameter in the first or second position,
and can be disposed on the smaller diameter in the defeated
position. Furthermore, a damper can be disposed on the pawl 82, for
example rubber, for reduced noise. The ratchet spring 87 can also
be dampened.
[0183] For purpose of illustration, reference is now made to the
operation of the system with the actuation assembly disclosed
herein. In operation, the user can deploy the trigger 60 from the
first position to the second position (referred to herein as the
"first action"). The trigger can cause movement of the trigger gear
sector 63. The trigger gear sector 63 can be functionally meshed
with the trigger pinion 64 and can cause rotation of the trigger
pinion 64. The trigger pinion 64 can be operatively coupled to the
slide pinion 65, and can cause rotation of the slide pinion 65. The
slide pinion 65 can be functionally engaged with the slide rack 66
and can cause the slide rack 66 to move distally. The slide rack 66
can be coupled to the driving rack 12, and the driving rack 12 can
also move distally. The driving rack 12 can be functionally coupled
to the actuation assembly, and can cause the inner shaft member 21
to move distally relative to the handle, and the outer tubular
member to move proximally relative to the handle, as described
herein above. Thus and as noted above, during the first action, the
inner shaft member 21 can move distally relative to the handle 1
and the outer tubular member 22 can move proximally relative to the
handle 1. During the first action, the pawl 82 can be in the first
state and can be configured to allow the trigger 60 to move toward
the second position and prohibit motion toward the first position.
The pawl 82 can be configured to switch from the first state to the
second state as the trigger approaches the second position from the
first position.
[0184] Upon return of the trigger 60 from the second position to
the first position (herein referred to as the "second action"),
which can be caused, for example, by the energy stored in the
spring 90, the trigger can cause movement of the trigger gear
sector 63 in the opposition direction as the first action. The
trigger gear sector 63 can cause rotation of the trigger pinion 64.
The trigger pinion 64 can cause rotation of the slide pinion 65.
The slide pinion 65 can cause the slide rack 66 to move proximally.
The driving rack 12 can be functionally coupled to the actuation
assembly, and can cause the inner shaft member 21 to move
proximally relative to the handle, and the outer tubular member 22
remain stationary relative to the handle, as described herein
above. Thus and as noted above, during the second action, the inner
shaft member 21 moves proximally relative to the handle 1 and the
outer tubular member 22 is stationary relative to the handle.
During the second action, the pawl 82 can be in the second state
and can be configured to allow the trigger 60 to move toward the
first position and prohibit motion toward the second position. The
pawl 82 can be configured to switch from the second state to the
first state as the trigger approaches the first position from the
second position.
[0185] In accordance with an alternative embodiment of the
disclosed subject matter, a delivery system is provided wherein the
trigger is coupled to the driving rack by a plurality of link
elements. FIGS. 86-88 depict for the purpose of illustration and
not limitation, portions of the delivery system 1001 described
herein above. Elements that are similar to the previously described
embodiment have been given like numbers. The delivery system 1001
can be configured to deliver an implant in a similar manner as
described herein above.
[0186] With reference to the exemplary embodiment herein, the
trigger 160 can be coupled to the driving rack 112 by a plurality
of link elements. The link elements can include a first and second
linear links 171 and 172, a triangle link 173, and a slide 161. A
base 181 can support the slide 161 and can have a trigger ratchet
rack 183 disposed thereon. The first linear link 171 can be coupled
to the trigger 160 at a first joint 174. The second linear link can
be coupled to the slide 161 at a second joint 175. The triangle
link 173 can be coupled to the first linear link 171 at a third
joint 176 and the second linear link 172 at a fourth joint 177. The
triangle link 173 can be coupled to the handle at a fifth joint 178
and the trigger 160 can be coupled to the handle at a sixth joint
179. Each of the first, second, third, fourth, fifth, and sixth
joints (174-179) can be pivot joints. The third joint 176, fourth
joint 177, and fifth joint 178 can define a triangle. The slide 161
can be coupled to the driving rack 112. The driving rack 112 can be
fixedly coupled or releasably coupled to the slide 161. As an
example and not by way of limitation, the driving rack 112 can have
a bayonet-type engagement with the slide 161 (sometimes referred to
herein as an intermediate element). A spring (not shown), such as a
constant force spring or tape measure spring, can be coupled to the
slide 161 and configured to bias the trigger 160 toward the first
position. The spring can be supported in base 181. In particular
embodiments, the spring can be coupled to any suitable link of the
plurality of links to bias the trigger 160 toward the first
position.
[0187] With reference to FIG. 88, for the purpose of illustration
and not limitation, the system can also include a ratchet mechanism
180. The ratchet mechanism 180 can include a first state and a
second state. The first state can be configured to allow the
trigger 160 to move toward the second position and prohibit motion
toward the first position. The second state can be configured to
allow the trigger 160 to move toward the first position and
prohibit motion toward the second position. Such a system can be
configured to require the user to perform a full stroke of the
trigger 160 between the first and second position, such as
described above.
[0188] As embodied herein, for illustration and not limitation, the
ratchet mechanism 180 can include a first pawl 182 as well as a
second pawl 184. The first and second pawls 182 and 184 can be
supported on the slide 161 and can include a ratchet trip 185
disposed between the first and second pawls 182 and 184. The first
and second pawls 182 and 184 can each have a first state in which
the pawls engage the trigger ratchet rack 183 to permit
unidirectional motion of the slide. The first pawl 182 can allow
motion in a first direction and the second pawl 182 can allow
motion in a second direction. The first and second pawls 182 and
184 can each have a second state wherein the first and second pawls
182 and 184 do not engage the trigger ratchet rack 183. That is,
when the first pawl 182 is in the first state the second pawl 184
can be in the second state, and when the second pawl 184 is in the
first state the first pawl 182 can be in the second state. As the
trigger 160 approaches the second position from the first position,
the ratchet trip 185 can cause the first pawl 182 to switch (or
disengage) to from the first state to the second state and the
ratchet trip 185 can cause the second pawl 184 to switch (or
engage) from the second state to the first state. Likewise, as the
trigger 160 approaches the first position from the second position,
the ratchet trip 185 can cause the first pawl 182 to switch (or
engage) from the second state to the first state and the ratchet
trip 185 can cause the second pawl 184 to switch (or disengage)
from the first state to the second state. The system can be
configured to ensure that the pawls are not simultaneous in the
first state. The first pawl 182 and the second pawl 184 can each be
in the second position at the same time to defeat the ratchet
mechanism 180. Furthermore, the pawls and springs can be damped as
described hereinabove.
[0189] In operation of this exemplary embodiment, the user can
deploy the trigger 160 from the first position to the second
position (referred to herein as the "first action"). The trigger
160 can pivot at the sixth joint 179 (clockwise in FIG. 86). The
trigger 160 can pull on the first linear link 171, which can cause
the triangle link 173 to pivot at fifth joint 178 (counter
clockwise in FIG. 86). The triangle link 173 can pull second linear
link 172 proximally, which can pull slide 161, and therefore
driving rack 112, proximally. The driving rack 112 can be
functionally coupled to the actuation assembly, and can cause the
inner shaft member 121 to move distally relative to the handle, and
the outer tubular member 222 to move proximally relative to the
handle, as described above. Thus and as noted above, during the
first action, the inner shaft member 121 can move distally relative
to the handle 101 and the outer tubular member 122 can move
proximally relative to the handle 101. During the first action, the
first pawl 182 can be in the first state and can be configured to
allow the trigger 160 to move toward the second position and
prohibit motion toward the first position. The second pawl 184 can
be in the second position, and thus not engaged with the trigger
ratchet rack 183. First and second pawls 182 and 184 can be
configured to switch from the first state to the second state and
from the second state to the first state, respectively, as the
trigger approaches the second position from the first position. The
transition of each pawl can be timed such that each pawl 182 and
184 is in the second state for a period of time before the second
pawl 184 switches to the first state.
[0190] Upon return of the trigger 160 from the second position to
the first position (herein referred to as the "second action"),
which can be caused, for example, by the energy stored in the
spring 190, the trigger 160 can pivot at the sixth joint 179
(counter clockwise in FIG. 86). The trigger can push on the first
linear link 171, which can cause the triangle link 173 to pivot at
fifth joint 178 (clockwise in FIG. 86). The triangle link 173 can
push the second linear link 172 distally, which can push slide 161,
and therefore driving rack 112, distally. The driving rack 112 can
be functionally coupled to the actuation assembly, and can cause
the inner shaft member 121 to move proximally relative to the
handle, and the outer tubular member 122 remain stationary relative
to the handle, as described above. Thus and as noted above, during
the second action, the inner shaft member 121 moves proximally
relative to the handle 101 and the outer tubular member 122 is
stationary relative to the handle. During the second action, the
second pawl 184 can be in the first state and can be configured to
allow the trigger 160 to move toward the first position and
prohibit motion toward the second position. The first pawl 182 can
be in the second position and thus not engaged with the trigger
ratchet rack 183. First and second pawls 182 and 184 thus can be
configured to switch from the second state to the first state and
from the first state to the second state, respectively, as the
trigger approaches the first position from the second position.
Additionally or alternatively, the transition of each pawl can be
timed such that each pawl 182 and 184 is in the second state for a
desired period of time before the first pawl 182 switches to the
first state.
[0191] As embodied herein, upon deployment of the trigger 160 from
the first position to the second position and return of the trigger
160 from the second position to the first position, the third joint
176 can trace a non-linear path. Such non-linear motion can result
in a variable force required to move the trigger 160 between
positions along the path of the trigger 160.
[0192] In accordance with an alternative embodiment of the
disclosed subject matter, a delivery system is provided wherein the
trigger is coupled to the driving rack by a trigger pulley system.
Referring now to FIG. 88 for the purpose of illustration and not
limitation, a perspective view of delivery system 1002 is provided.
Portions of this exemplary embodiment are depicted in FIGS. 90 and
91. Elements that are similar to the previously described
embodiment have been given like numbers. The delivery system 1002
can be configured to deliver an implant in a similar manner as
described herein above.
[0193] The trigger 260 can be coupled to the driving rack 212 by a
trigger pulley system. For example, the trigger 260 can be coupled
to the handle at joint 279, which can be a pivot joint. The trigger
260 can be coupled to the slide 261 by a tether 288. The slide 261
can be coupled to the driving rack 212. The driving rack 212 can be
fixedly coupled or releasably coupled to the slide 261. As an
example and not by way of limitation, the driving rack 212 can have
a bayonet-type engagement with the slide 261 (sometimes referred to
herein as an intermediate element). Additionally, the slide can be
coupled to a spring 290, for example, a constant force spring. The
spring 290 can bias the slide toward a distal position and the
trigger 260 in the first position. The spring can be supported in
base 281. Additionally, the handle 201 can include a window 289
(FIG. 89), which can be used to manually move the slide.
[0194] In operation, the user can deploy the trigger 260 from the
first position to the second position (referred to herein as the
"first action"). The trigger 260 can pivot at the joint 279
(clockwise in FIG. 90). The tether 288 coupled to the trigger 260
and the slide 261 can pull the slide 261, and therefore the driving
rack 212, proximally. The driving rack 212 can be functionally
coupled to the actuation assembly, and can cause the inner shaft
member 221 to move distally relative to the handle, and the outer
tubular member 222 to move proximally relative to the handle, as
described hereinabove. Thus and as noted above, during the first
action, the inner shaft member 221 can move distally relative to
the handle 201 and the outer tubular member 222 can move proximally
relative to the handle 201.
[0195] Upon return of the trigger 260 from the second position to
the first position (herein referred to as the "second action"),
which can be caused, for example, by the energy stored in the
spring 290 pulling the slide 261 distally, the driving rack 212 can
be moved distally. The driving rack 212 can be functionally coupled
to the actuation assembly, and can cause the inner shaft member 221
to move proximally relative to the handle, and the outer tubular
member 222 remain stationary relative to the handle, as described
hereinabove. Thus and as noted above, during the second action, the
inner shaft member 221 moves proximally relative to the handle 201
and the outer tubular member 222 is stationary relative to the
handle.
[0196] Referring now to FIG. 92 for the purpose of illustration and
not limitation, an exploded view of delivery system 1003 is
provided. Elements that are similar to the previously described
embodiment have been given like numbers. The delivery system 1003
can be configured to deliver an implant in a similar manner as
described herein above.
[0197] The trigger 360 can include a slide 361 that can include an
engagement surface 362 to be engaged by the user. The driving rack
312 can be fixedly coupled or releasably coupled to the slide 361.
As an example and not by way of limitation, the driving rack 312
and the slide 361 can be a unitary member. The trigger 360 can be
coupled to a spring, which can bias the trigger 360 toward the
first position.
[0198] During operation, the user can deploy the trigger 360 from
the first position to the second position (referred to herein as
the "first action"). The trigger, and therefore the slide 361 and
the driving rack 312, can move in a proximal direction. The driving
rack 312 can be functionally coupled to the actuation assembly, and
can cause the inner shaft member 321 to move distally relative to
the handle, and the outer tubular member 322 to move proximally
relative to the handle, as described above. Thus and as noted
above, during the first action, the inner shaft member 321 can move
distally relative to the handle 301 and the outer tubular member
322 can move proximally relative to the handle 301.
[0199] Upon return of the trigger 360 from the second position to
the first position (hereinafter referred to as the "second
action"), the trigger 360, and therefore the slide 361 and the
driving rack 312 can move in a distally relative to the handle 301.
The driving rack 312 can be functionally coupled to the actuation
assembly, and can cause the inner shaft member 321 to move
proximally relative to the handle, and the outer tubular member 322
remain stationary relative to the handle, as described above. Thus
and as noted above, during the second action, the inner shaft
member 321 moves proximally relative to the handle 301 and the
outer tubular member 322 is stationary relative to the handle.
[0200] FIGS. 93 and 94 provide, for the purpose of illustration and
not limitation, portion of delivery system 1004. Elements that are
similar to the previously described embodiment have been given like
numbers. The delivery system 1004 can be configured to deliver an
implant in a similar manner as described herein above.
[0201] The trigger 460 can include a slide 461 that can include an
engagement surface 462 to be engaged by the user. The driving rack
412 can be fixedly coupled or releasably coupled to the slide 461.
As an example and not by way of limitation, the driving rack 412
and the slide 461 can be a unitary member. The trigger 460 can be
coupled to a spring, which can bias the trigger 460 toward the
first position.
[0202] During operation, the user can deploy the trigger 460 from
the first position to the second position (referred to herein as
the "first action"). The trigger, and therefore the slide 461 and
the driving rack 412, can move in a distal direction. The driving
rack 412 can be functionally coupled to the actuation assembly, and
can cause the inner shaft member 421 to move distally relative to
the handle, and the outer tubular member 422 to move proximally
relative to the handle, as described above. Thus and as noted
above, during the first action, the inner shaft member 421 can move
distally relative to the handle 301 and the outer tubular member
422 can move proximally relative to the handle 401.
[0203] Upon return of the trigger 460 from the second position to
the first position (herein referred to as the "second action"), the
trigger 460, and therefore the slide 461 and the driving rack 412
can move in a proximal relative to the handle 401. The driving rack
412 can be functionally coupled to the actuation assembly, and can
cause the inner shaft member 421 to move proximally relative to the
handle, and the outer tubular member 422 remain stationary relative
to the handle, as described above. Thus and as noted above, during
the second action, the inner shaft member 421 moves proximally
relative to the handle 401 and the outer tubular member 422 is
stationary relative to the handle.
[0204] FIGS. 95 and 96 provide, for the purpose of illustration and
not limitation, portion of delivery system 1005. Elements that are
similar to the previously described embodiment have been given like
numbers. The delivery system 1005 can be configured to deliver an
implant in a similar manner as described herein above.
[0205] The trigger 560 can include a slide 561 that can include an
engagement surface 562 to be engaged by the user. The driving rack
512 can be fixedly coupled or releasably coupled to the slide 561.
As an example and not by way of limitation, the driving rack 512
and the slide 561 can be a unitary member. The trigger 560 can be
coupled to a spring, which can bias the trigger 560 toward the
first position.
[0206] During operation, the user can deploy the trigger 560 from
the first position to the second position (referred to herein as
the "first action"). The trigger, and therefore the slide 561 and
the driving rack 512, can move in a distal direction. The driving
rack 512 can be functionally coupled to the actuation assembly, and
can cause the inner shaft member 521 to move distally relative to
the handle, and the outer tubular member 522 to move proximally
relative to the handle, as described above. Thus and as noted
above, during the first action, the inner shaft member 521 can move
distally relative to the handle 501 and the outer tubular member
522 can move proximally relative to the handle 501.
[0207] Upon return of the trigger 560 from the second position to
the first position (herein referred to as the "second action"), the
trigger 560, and therefore the slide 561 and the driving rack 512
can move in a proximal relative to the handle 501. The driving rack
512 can be functionally coupled to the actuation assembly, and can
cause the inner shaft member 521 to move proximally relative to the
handle, and the outer tubular member 522 remain stationary relative
to the handle, as described above. Thus and as noted above, during
the second action, the inner shaft member 521 moves proximally
relative to the handle 501 and the outer tubular member 522 is
stationary relative to the handle.
[0208] The embodiments described above can be formed of any
suitable materials, for example, the handle and actuation assembly
elements can be made from plastic, composites, or metal. As an
example, and not by way of limitation, the gears, (for example, the
sun gear shaft, planet carrier, planet gears, intermediate gear and
ring gear), clutch drivers, shuttle frame, driving rack, and clutch
release can be formed by silicon impregnated poly oxymethylene or
acetal (e.g., DelRin.RTM. sold by DuPont). The ratchet rack can be
made of TOPAS. The various pins and springs can be formed from
plastic, metal (e.g., stainless steel or aluminum), or music wire.
The plate can be formed from plastic or metal. The handle housing
portion can be made from glass filled plastics or other plastic
resins, for example ADS, polycarbonate, or an ADS polycarbonate
blend. A rubber overmold can be used for grip and aesthetics, for
example, on the trigger and the handle body. The strain relief can
be a soft plastic, for example, polyethylene. The trigger and
related elements can be formed by silicon impregnated poly
oxymethylene or acetal (e.g., DelRin.RTM. sold by DuPont). The
various pins and springs can be formed from plastic, metal (e.g.,
stainless steel or aluminum), or music wire. Spring dampers can be
made of UNA, EPVM, Silicon, Eurothane, or Santoprene.
[0209] As disclosed herein, a delivery system can be provided with
one or more of the described actuations assemblies, trigger
assemblies or ratchet mechanisms. For example, a delivery system
can be provided including a handle; a trigger operatively coupled
to the handle; an actuation assembly operatively coupled to the
trigger, the inner shaft member, and the outer tubular member, the
actuation assembly having a planet carrier; at least one planet
gear operatively coupled to the planet carrier; a sun gear shaft
operatively engaged with the planet gear; a ring gear operatively
engaged with the planet gear; a first clutch driver configured to
limit the sun gear shaft to uni-directional rotational motion; and
a second clutch driver configured to uni-directionally lock the sun
gear shaft and the planet carrier; and a gear train functionally
disposed between the trigger and the actuation assembly, the
trigger having a trigger gear sector, a trigger pinion operatively
meshed with the trigger gear sector, a slide pinion operatively
coupled to the trigger pinion, and a slid rack disposed on a slide
and operatively meshed with the trigger pinion. The actuation
assembly is configured to displace the outer tubular member in the
proximal direction a distance (d) relative to the handle and to
separately move the inner shaft member distally a distance (x)
relative to the handle upon deployment of the trigger from a first
position to a second position, and further wherein the actuation
assembly is configured to move the inner shaft member proximally a
distance (y) relative to the handle with no displacement of the
outer tubular member relative to the handle upon return of the
trigger from the second position to the first position.
[0210] Additionally, and in accordance with the disclosed subject
matter, a delivery system can be provided including a handle; a
trigger operatively coupled to the handle; an actuation assembly
including a planetary gear system; and a ratchet mechanism
functionally coupled to the trigger. The actuation assembly is
configured to displace the outer tubular member in the proximal
direction a distance (d) relative to the handle and to separately
move the inner shaft member distally a distance (x) relative to the
handle upon deployment of the trigger from a first position to a
second position, and further wherein the actuation assembly is
configured to move the inner shaft member proximally a distance (y)
relative to the handle with no displacement of the outer tubular
member relative to the handle upon return of the trigger from the
second position to the first position
[0211] Furthermore, and in accordance with the disclosed subject
matter, a delivery system can be provided including a handle; a
trigger operatively coupled to the handle; an actuation assembly
operatively coupled to the trigger, the inner shaft member, and the
outer tubular member, the actuation assembly having a planet
carrier; at least one planet gear operatively coupled to the planet
carrier; a sun gear shaft operatively engaged with the planet gear;
a ring gear operatively engaged with the planet gear; a first
clutch driver configured to limit the sun gear shaft to
uni-directional rotational motion; and a second clutch driver
configured to uni-directionally lock the sun gear shaft and the
planet carrier; a gear train functionally disposed between the
trigger and the actuation assembly, the trigger having a trigger
gear sector, a trigger pinion operatively meshed with the trigger
gear sector, a slide pinion operatively coupled to the trigger
pinion, and a slid rack disposed on a slide and operatively meshed
with the trigger pinion. The actuation assembly is configured to
displace the outer tubular member in the proximal direction a
distance (d) relative to the handle and to separately move the
inner shaft member distally a distance (x) relative to the handle
upon deployment of the trigger from a first position to a second
position, and further wherein the actuation assembly is configured
to move the inner shaft member proximally a distance (y) relative
to the handle with no displacement of the outer tubular member
relative to the handle upon return of the trigger from the second
position to the first position.
[0212] While the disclosed subject matter is described herein in
terms of certain preferred embodiments for purpose of illustration
and not limitation, those skilled in the art will recognize that
various modifications and improvements can be made to the disclosed
subject matter without departing from the scope thereof. Moreover,
although individual features of one embodiment of the disclosed
subject matter can be discussed herein or shown in the drawings of
one embodiment and not in other embodiments, it should be readily
apparent that individual features of one embodiment can be combined
with one or more features of another embodiment or features from a
plurality of embodiments.
[0213] In addition to the specific embodiments claimed below, the
disclosed subject matter is also directed to other embodiments
having any other possible combination of the dependent features
claimed below and those disclosed above. As such, the particular
features presented in the dependent claims and disclosed above can
be combined with each other in other possible combinations. Thus,
the foregoing description of specific embodiments of the disclosed
subject matter has been presented for purposes of illustration and
description. It is not intended to be exhaustive or to limit the
disclosed subject matter to those embodiments disclosed.
[0214] The following applications, which are filed on the same day
as this application, are incorporated by reference in their
entirety: U.S. patent application Ser. No. 14/932,848; U.S. patent
application Ser. No. 14/932,875; U.S. patent application Ser. No.
14/932,862; U.S. patent application Ser. No. 14/932,884; U.S.
patent application Ser. No. 14/932,795; U.S. patent application
Ser. No. 14/932,805; U.S. patent application Ser. No. 14/932,830;
PCT Application No. PCT/US2015/059070; PCT Application No.
PCT/US2015/059074; and PCT Application No. PCT/US2015/059084.
[0215] Furthermore, it is recognized that the actuation assembly
and delivery system as disclosed herein can be used in a method of
delivering an implant. That is, for purpose of illustration, such
method would include providing a delivery system as disclosed
herein, positioning the distal end portion of the outer tubular
member proximate a desired site, and deploying the delivery system
to push the implant from the outer tubular member to the desired
site.
[0216] It will be apparent to those skilled in the art that various
modifications and variations can be made in the method and system
of the disclosed subject matter without departing from the spirit
or scope of the disclosed subject matter. Thus, it is intended that
the disclosed subject matter include modifications and variations
that are within the scope of the appended claims and their
equivalents.
* * * * *