U.S. patent application number 10/824033 was filed with the patent office on 2005-01-27 for variable speed self-expanding stent delivery system and luer locking connector.
Invention is credited to Dorn, Jurgen, Vogel, Michael.
Application Number | 20050021123 10/824033 |
Document ID | / |
Family ID | 49753717 |
Filed Date | 2005-01-27 |
United States Patent
Application |
20050021123 |
Kind Code |
A1 |
Dorn, Jurgen ; et
al. |
January 27, 2005 |
Variable speed self-expanding stent delivery system and luer
locking connector
Abstract
A stent delivery system that includes an inner member and an
outer retractable sheath is operated by a handle that permits
retraction of the sheath at more than one speed. The sheath may be
retracted in small, incremental steps or in a single, more rapid
stroke. Means also are provided for releasably locking the inner
member and outer sheath in a fixed position as well as to
facilitate admission of liquid into the device.
Inventors: |
Dorn, Jurgen; (Neulussheim,
DE) ; Vogel, Michael; (Karlsruhe, DE) |
Correspondence
Address: |
KIRKPATRICK & LOCKHART LLP
75 STATE STREET
BOSTON
MA
02109-1808
US
|
Family ID: |
49753717 |
Appl. No.: |
10/824033 |
Filed: |
April 14, 2004 |
Current U.S.
Class: |
623/1.11 |
Current CPC
Class: |
A61M 39/1011 20130101;
A61F 2/966 20130101; A61F 2/9517 20200501; A61F 2/95 20130101 |
Class at
Publication: |
623/001.11 |
International
Class: |
A61F 002/06 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 30, 2001 |
GB |
0110551.9 |
Jun 19, 2001 |
GB |
0114939.2 |
Apr 29, 2002 |
WO |
PCT/EP02/04727 |
Jun 19, 2002 |
WO |
PCT/EP02/06784 |
Claims
1. A connector which comprises the male portion of a luer
connector, characterized in that the male portion 132 is extended
axially into a pressure paid (8) having a pressure surface.
2. A device for passing fluid into an annular cavity between an
inner elongate body (126) and an outer elongate tubular body (128),
the device having a housing (2) with a distal end (24), a proximal
end (112) and an off-axis end (136), the housing providing a
seating at the distal end thereof for the outer elongate tubular
body along an axis of the housing extending between the proximal
and the distal end, the distal and off-axis ends defining
respective openings (130, 131) which are in fluid communication
with each other, and the proximal end having a lumen (123) to
enable the inner elongate body to extend from the housing both
distally and proximally, along the axis thereof: characterized by:
a pressure pad (8) mounted to the housing and extending into the
cavity from the off-axis opening of the housing and movable between
a locking disposition, in which the pad (8) bears on the locus of
the inner elongate body (126) for preventing axial movement thereof
with respect to the outer body (128), and simultaneously allows
injection of fluid into the annular cavity (130), and a release
disposition in which the pad is spaced from the locus of the inner
elongate body for permitting axial movement of the inner body with
respect to the outer body.
3. Stent delivery system comprising an inner elongate body (126)
and an outer elongate tubular body (128) which are coaxially
arranged, a pull-back device (170) enabling proximal displacement
of the outer body with respect to the inner body for releasing a
stent contained within an annular cavity formed between the inner
and outer body, into a body lumen, a device (1) for passing fluid
into the annular cavity having a housing (2) with a distal end
(124), a proximal end (112) and an off-axis end (136), the housing
provides a seating at the distal end thereof for the outer elongate
tubular body along an axis of the housing extending between the
proximal and the distal end, the distal and off-axis ends defining
respective openings (30, 31) which are in fluid communication with
each other, and the proximal end having a lumen (23) to enable the
inner elongate body to extend from the housing both distally and
proximally, along the axis thereof, the stent delivery system being
characterized by a locking and release device (1) mounted to the
housing (2) and extending into the off-axis opening of the housing
to bear, in a locking disposition, against the inner body to
prevent axial movement thereof with respect to the outer body, and
to simultaneously allow injection of fluid into the annular cavity
and, in a released disposition, to be spaced from the inner body to
permit axial movement of the inner body with respect to the outer
body.
4. A device (1) for releasing into the body from a delivery system
a medical prosthesis mounted on the delivery system and held by a
constraint (16) in a constrained delivery disposition, the device
comprising: a first abutment (28) for the delivery system; a second
abutment (18) for an elongate element (30) to connect the device to
the prosthesis constraint; a track (14) for the second abutment
(18) to advance along, from a starting point corresponding to
constraint of the prosthesis, to a finishing point corresponding to
separation of the prosthesis and constraint (16); ratchet means
(38) to advance the second abutment (18) progressively, from the
starting point to the finishing point, in a plurality of actuation
strokes; and characterized by: a full stroke actuator (24), to
advance the second abutment (18) all the way from an intermediate
point on said track (14) to said finishing point in one single
stroke of the said actuator (24), the intermediate point being
selectable by the user within a portion of the track (14) which
extends over at least half the length of the track.
5. A method for releasing into the body from a delivery system a
medical prosthesis mounted on the delivery system and held by a
constraint in a constrained delivery system, the method comprising
a first release phase characterized by stepwise release of a first
portion of the prosthesis, by successive actuation strokes of a
ratchet means, followed by a second phase of release of the
prosthesis, characterised by a single stroke of a full stroke
prosthesis release actuator.
6. A medical device delivery system for therapeutically treating a
patient, comprising: an inner shaft, having proximal and distal
ends; a tubular outer sheath, at least a portion of which surrounds
a portion of the inner shaft member; a medical device within the
outer sheath in an initial configuration; a handle operatively
coupled with the inner shaft and the outer sheath; the handle
having a first and second actuator for adjusting the relative
positions of the inner shaft and the outer sheath, each of the
first and second actuators providing a different amount of
mechanical advantage between an input to one of the first and
second actuators by a physician and a resulting relative position
of the inner shaft and the outer sheath respectively.
7. The medical device delivery system of claim 6, wherein one of
the first and second actuators provides a mechanical advantage of
1:1.
8 The medical device delivery system of claim 6, wherein the second
actuator is adapted to slide along a longitudinal slot defined by
the handle.
9. The medical device delivery system of claim 6, wherein one of
the first and second actuators is formed as a lever.
10. The medical device delivery system of claim 6, wherein the
first actuator provides a mechanical advantage greater than 1:1, to
facilitate an operator to overcome initial resistance to changing
the initial relative position of the inner shaft and the outer
sheath.
11. A handle for manipulating a medical device delivery system for
therapeutically treating a patient, comprising: a housing; inner
and outer shaft members; the inner shaft member being affixed to
the housing; the outer shaft member being movably coupled to the
inner shaft member, such that the outer shaft member can be moved
longitudinally with respect to the inner shaft member; first and
second means for selectively moving the outer shaft member with
respect to the inner shaft member; the first means being adapted
for precise and sensitive adjustment of the position of the outer
shaft member, and the second means being adapted for rapid and
relatively large-scale movement of the outer shaft member.
12. A medical device delivery system for therapeutically treating a
patient, comprising: an inner shaft, having proximal and distal
ends; a tubular outer sheath, at least a portion of which surrounds
a portion of the inner shaft member; a medical device within the
outer sheath in an initial configuration; a handle operatively
coupled with the inner shaft and the outer sheath; the handle
having a first and second actuator for adjusting the relative
positions of the inner shaft and the outer sheath, each of the
first and second actuators providing a different amount of
mechanical advantage between an input to one of the first and
second actuators by a physician and a resulting relative position
of the inner shaft and the outer sheath respectively; and a locking
member that releasably holds the outer sheath relative to the inner
shaft in an initial configuration, thereby holding the outer sheath
in the initial configuration and tending to resist inadvertently
uncovering the medical device.
13. The medical device delivery system of claim 12, wherein the
first actuator provides a mechanical advantage of 1:1.
14. The medical device delivery system of claim 12, wherein the
first actuator is adapted to slide along a longitudinal slot
defined by the handle.
15. The medical device delivery system of claim 12, wherein the
second actuator provides a mechanical advantage greater than 1:1,
to facilitate an operator to overcome initial resistance to
changing the initial relative position of the inner shaft and the
outer sheath.
16. The medical device delivery system of claim 12, wherein one of
the first and second actuators is formed as a lever.
17. The medical device delivery system of claim 12, further
comprising a guidewire lumen for slidably receiving a flexible
guidewire.
18. The medical device delivery system of claim 12, wherein the
medical device is a stent.
19. The medical device delivery system of claim 18, wherein the
stent is of the self-expanding type.
20. A handle for manipulating a medical device delivery system for
therapeutically treating a patient, comprising: a housing; first
and second shaft members; the first shaft member being affixed to
the housing; the second shaft member being movably coupled to the
first shaft member, such that the second shaft member can be moved
longitudinally with respect to the first shaft member; first and
second means for selectively moving the second shaft member with
respect to the first shaft member; the first means being adapted
for precise and sensitive adjustment of the position of the second
shaft member, and the second means being adapted for rapid and
relatively large-scale movement of the second shaft member; and a
locking member that releasably holds the first and second shafts in
a constant initial relative position.
21. A method for therapeutically treating a patient, comprising the
steps of: (a) providing a medical device delivery system having
proximal and distal ends; a handle near the proximal end; a medical
device for delivery by the delivery system and for performing a
therapeutic procedure at a desired site for treatment; a delivery
mechanism for selectively and progressively releasing the medical
device; and a locking member that holds the delivery mechanism in
an initial configuration, the locking member tending to releasably
resist inadvertent release of the medical device by the delivery
mechanism; wherein the medical device is positioned within the
delivery mechanism; wherein the handle has a first and second
actuator coupled to the delivery mechanism; (b) inserting the
medical device delivery system along a body passage until the
distal end of the delivery system is positioned at or near the
desired site for treatment; (c) unlocking the locking member; (d)
moving the first actuator on the handle a first selected amount;
such movement of the first actuator causing the delivery mechanism
to move an amount at a first proportional rate in a precise manner,
and causing the delivery mechanism to partially release the medical
device; (e) moving the second actuator on the handle, causing the
delivery mechanism to move at a second greater proportional rate in
a rapid manner, to fully release the medical device; and (f)
withdrawing and removing the medical device delivery system from
the body passage, and allowing the medical device to remain at the
desired site for treatment.
22. The method as set forth in claim 21, further comprising,
between steps (d) and (e), the additional steps of: evaluating in
greater detail the position of the medical device compared to the
position of the desired site to be treated; and adjusting the
position of the medical device delivery system based on the
evaluation.
23. A method for therapeutically treating a patient, comprising the
steps of: (a) providing a medical device delivery system having
proximal and distal ends; a handle near the proximal end; a medical
device for delivery by the delivery system and for performing a
therapeutic procedure at a desired site for treatment; a delivery
mechanism for selectively and progressively releasing the medical
device; and a locking member that holds the delivery mechanism in
an initial configuration, the locking member tending to releasably
resist inadvertent release of the medical device by the delivery
mechanism; wherein the medical device is positioned within the
delivery mechanism; the handle has a first and second actuator
coupled to the delivery mechanism; the first actuator is a
rotatable knob; and the second actuator is a longitudinal slider;
(b) inserting the medical device delivery system along a body
passage until the distal end of the delivery system is positioned
at or near the desired site for treatment; (c) unlocking the
locking member; (d) rotating the first actuator on the handle a
selected amount; such rotation of the first actuator causing the
delivery mechanism to move an amount in a precise manner, and
causing the delivery mechanism to partially release the medical
device; (e) sliding the second actuator on the handle
longitudinally, causing the delivery mechanism to move in a rapid
manner, to fully release the medical device; and (f) withdrawing
and removing the medical device delivery system from the body
passage, and allowing the medical device to remain at the desired
site for treatment.
24. The method as set forth in claim 23, further comprising,
between steps (d) and (e), the additional steps of: evaluating in
greater detail the position of the medical device compared to the
position of the desired site to be treated; and adjusting the
position of the medical device delivery system based on the
evaluation.
Description
FIELD OF THE INVENTION
[0001] This invention relates to stent delivery systems.
BACKGROUND
[0002] The deployment of stents at a stenting site within a human
or animal body requires careful handling of the stent delivery
system to be used for deploying the stent. Exact positioning of the
stent at the site of the stenosis prior to and during deployment is
essential. The accuracy with which the stent can be deployed with
respect to the occlusion inside the body lumen, as well as the
skills of the surgeon in controlling the stent delivery system,
will having an impact on the outcome of the operation.
[0003] Normally, a guidewire is used, to advance a stent delivery
system containing the stent to be deployed into the body to the
site of the stenosis. Once the distal end of the delivery system
has reached the stenting site and the stent to be released is
correctly located, the stent is released. To deploy a
self-expanding stent it is known to gradually withdraw an outer
sheath (otherwise called sleeve) holding the stent in a radially
compressed configuration and thereby allow the stent to radially
expand and to anchor itself inside the body lumen. In commercially
available delivery systems, the stent is prevented by an inner
catheter from moving proximally with the sleeve as it retreats
proximally, and is held in a radially compressed state by a
co-axially disposed outer sheath or sleeve enclosing the stent and
the inner catheter. The relative axial positions of the inner
catheter and the outer sleeve are varied by manipulation of the
delivery system.
[0004] Since the stent as well as the stenosis are not directly
visible to the surgeon performing the operation, the stent
deployment procedure requires a visualization procedure, usually
the injection of a radiopaque fluid, in order to visualize the
location of the stent inside the body lumen. The fluid is injected
into an annular cavity between the inner catheter and the outer
sheath. The position of the stent as well as the location of the
stenosis itself can then be monitored from outside the patient's
body by using X-ray imaging machines showing the images of
radiopaque marker rings on the distal end of the delivery system
and a reduced intensity image corresponding to the constricted
volume of radiopaque fluid through the occluded site. This allows
the surgeon/radiologist to find the location of the stenosis and
place the stent with sufficient accuracy.
[0005] During the course of the delivery procedure, the radially
compressed stent is held axially at a fixed position by a pusher
surface of the inner catheter, which typically abuts the proximal
end of the stent inside the outer sheath of the delivery system.
The proximal, movement of the outer sheath to release the stent
exerts a proximally directed force onto the stent which urges the
stent to move in the same way. The surgeon has to counteract this
tendency of the stent to move proximally by applying an adequate,
distally-directed force onto the pusher element in order to off-set
the opposing forces and to thereby keep the position of the stent
fixed.
[0006] Typically, the stent is mounted into the delivery system at
a manufacturing site. Then, the entire assembly is sterilized and
air-tightly packed in a specially designed sealed enclosure. During
sterilization and packaging, there is always the risk that the
co-axial components of the assembly might move so that the outer
sheath may be displaced with respect to the inner catheter.
Consequently, the position of the stent might be changed during
these steps prior to its placement.
[0007] Therefore, it would be desirable to have a delivery system
with a fluid injection port which is protected against inadvertent
or premature movement of the outer sheath relative to the stent but
is still simple to use and economical to manufacture.
[0008] Some delivery devices are particularly applicable to the
release into the body of a self-expanding stent, such as one made
from nickel-titanium shape memory alloy. Self-expanding stents
usually have a basically cylindrical form prior to deployment and
it is conventional to deploy these stents with a system having two
components. One of these components is a sleeve or sheath which
surrounds the stent and constrains it to a radially compact
disposition. The other component is a so-called "pusher" which is
located inside the constraining sleeve and bears against a surface
of the stent. Deployment of the stent is then accomplished by
proximal withdrawal of the sleeve relative to the pusher. The
pusher maintains the stent in a location relative to the target
site of surgery. The proximal withdrawal of the sleeve
progressively releases the stent, first at its distal end and then
progressively proximally along the length of the stent until, when
the distal end of the sleeve is proximal of the proximal end of the
stent cylinder, the stent is fully deployed. At this point, the
sleeve and pusher delivery system can be withdrawn proximally out
of the body, leaving the stent, expanded, in the desired location.
An early disclosure of such a system can be found in Gianturco U.S.
Pat. No. 4,580,568.
[0009] Radiopaque markers on the stent delivery system (sometimes
supplemented by markers on the stent itself) are used to enable
radiologists to visualize the location of the stent in the body.
Furthermore, the stent delivery system is used as a conduit for
filling the bodily lumen to be stented with radiopaque fluid, to
enable the radiologist to pinpoint the location of the stenosis or
other surgical site where the stent is to be placed. It is then the
task of the medical practitioner performing the stenting procedure
to bring the radiopaque stent markers into the desired relationship
wit the site of surgery as indicated by the radiopaque fluid.
[0010] There continue to be difficulties for medical practitioners
in placing the stent exactly as required. What has been needed now
for many years is a delivery system which a medical practitioner
can manipulate manually with enough precision to bring the stent
reliably into the desired location relative to the surgical site.
It will be appreciated that stent delivery systems are commonly of
a length around 130 cm--such as when delivered by a Seldinger
technique--so the medical practitioner is to some extent
handicapped by having to work at considerable distance from the
stent itself.
[0011] Stents come in many different lengths. However, for all but
the shortest stent length, there are, to the knowledge of the
present inventor, two phases in any self-expanding stent deployment
sequence.
[0012] In a first phase, initial proximal withdrawal of the
surrounding sleeve releases the distal end of the stent so that
this part of the stent length begins to make contact with the
bodily lumen which defines the site of surgery. This first phase is
characterized in that the stent is still bound to the delivery
system and not to the bodily lumen. However, at the end of the
first phase, enough of the length of the stent has expanded into
contact with the lumen wall to fix the position of the stent
relative to the lumen wall. At this point, the stent is bound to
both the delivery system and the bodily lumen wall, so that any
axial movement of the delivery system relative to the bodily lumen
is liable to cause injury to the lumen wall.
[0013] The second phase of stent deployment is what follows
thereafter, namely, the remainder of the proximal movement of the
sheath to release the remaining length of the stent into the bodily
lumen. It will be appreciated that any axial stress on the deployed
portion of the length of the stent during deployment will transmit
to axial stress on that part of the bodily lumen which is in
binding engagement with the stent, with the consequence that lumen
wall supported by the stent remains in tension and under stress
after the stent has been fully deployed. This unwanted axial stress
in the bodily tissue could be severely deleterious to the patient
in one way or another and is normally to be avoided.
[0014] There are proposals in the patent literature for placement
of self-expanding stents by progressive distal advancement of a
surrounding sheath, to release the stent, proximal end first,
terminating at the distal end of the stent. It will be appreciated
that this is possible because the radial expansion of the stent
opens up a lumen big enough for proximal withdrawal of the sheath
from a position distal of the expanded stent. The discussion of
axial stresses can be applied, mutatis mutandis, to these
configurations proposed in the patent literature, in which the
proximal end of the stent is deployed first.
[0015] Also previously proposed are combinations of constraining
sheaths which withdraw from the stent simultaneously proximally and
distally, from a starting point intermediate the ends of the stent,
in order to deploy the stent first from a mid part of its length,
and terminating with deployment of both the proximal and distal
ends of the stent. Even in such systems, the concerns about axial
stresses still apply.
[0016] For a disclosure within the state of the art of a system
which distinguishes between the initial phase of stent deployment
and the subsequent phase in which the remainder of the length is
deployed, reference is made to WO 99/04728. In this disclosure, it
is proposed to use a stent delivery system which is characterized
by an initial mechanical advantage for the initial stages of stent
deployment, which is large enough to overcome static frictional
forces between the stent and the surrounding sheath and to allow
the initial part of the length of the stent to be deployed slowly
and precisely. Once the sheath has begun sliding over the stent
length, and an end of the stent has expanded to engage the
surrounding luminal wall, a different and lower mechanical
advantage is activated, to withdraw the sheath proximally at a rate
more rapid than that characteristic of the initial phase of stent
deployment.
[0017] It is the experience of the present inventor that individual
medical practitioners have developed their own preferred techniques
for precise deployment of stents. Looking at the proximal end of
the stent delivery system, with the actuator which the practitioner
actually handles during the stent deployment procedure, the state
of the art offers various configurations and the individual
practitioners select from these possibilities the actuators which
fit their particular manual skills best.
[0018] WO 99/04728, mentioned above, offers the practitioner a
knurled rotary actuation element whereas WO 00/18330, DE-A-44 20142
and WO 98/23241 are examples of pistol grip devices in which
deployment is accomplished by a form of squeeze handle or trigger.
See EP-A-747 021 and U.S. Pat. No. 5,433,723 for other examples of
rotary stent release devices.
[0019] Another approach to the accomplishment of a controlled
release of a self-expanding stent can be found in U.S. Pat. No.
5,683,451, the approach relying on so-called runners which lie
between the stent and a surrounding sheath. At the proximal end of
the delivery system, a follower receives a hub at the proximal end
of the surrounding sheath and rotation of a handle causes rotation
of a threaded shaft, along which the follower advances, to carry
the proximal hub of the sheath in a proximal direction to release
the stent.
SUMMARY OF THE INVENTION
[0020] One aspect of this invention relates to a device for
releasing into the body from a delivery system a medical prosthesis
mounted on the delivery system and held by a constraint in a
constrained delivery disposition. The device comprises a first
abutment for the delivery system, a second abutment for an elongate
element to connect the device to the prosthesis constraint, a track
for the second abutment to advance along, from a starting point
corresponding to constraint of the prosthesis, to a finishing point
corresponding to separation of the prosthesis and constraint, and
ratchet means to advance the second abutment progressively, from
the starting point to the finishing point, in a plurality of
actuation strokes.
[0021] According to one aspect of the present invention there is
provided a device for releasing into the body from a delivery
system a medical prosthesis mounted on the delivery system, of the
form discussed above, and characterized by a full stroke actuator,
to advance the second abutment all the way from an intermediate
point on said track to said finishing point in one single stroke of
the said actuator, the intermediate point being selectable by the
user within a portion of the track which extends over at least half
the length of the track.
[0022] In short, what the present inventor has found is that a
release device which embodies both a ratchet means and a full
stroke actuator is one which allows a range of individual medical
practitioners, all of whom have their own preferred techniques for
precise stent deployment, to practice their skilled techniques in
the way that suits them best, to lay down an initial part of the
length of a stent in a precise location in a bodily lumen, and then
to complete the deployment of the length of the stent in a way
which is so accurately and precisely controlled that the
practitioner can satisfactorily avoid imposing unacceptable axial
stresses on the tissue being stented.
[0023] In presently preferred embodiment, the device of the
invention is realized in a device which offers the medical
practitioner a trigger for successive pumping to withdraw the
stent-surrounding sheath proximally stepwise, together with a
slider which allows the operator to withdraw the sleeve in one
stroke. Thus, the trigger provides the ratchet means of the
invention and the slider provides the full stroke actuator of the
invention. The inventor envisages that it will be convenient for
many practitioners to utilize the trigger during the first phase of
stent deployment and then, when satisfied that the stent is placed
within the bodily lumen as desired, switch from the trigger to the
slider in order to deploy the remaining length of the stent with as
much fingertip sensitivity as possible, thereby to minimize the
imposition of unwanted stresses on the bodily tissue.
[0024] Accordingly, in another aspect of the invention, there is
provided a method for releasing into the body from a delivery
system a medical prosthesis mounted on the delivery system and held
by a constraint in a constrained delivery system, the method
comprising
[0025] a first release phase characterized by stepwise release of a
first portion of the prosthesis, by successive actuation strokes of
a ratchet means, followed by
[0026] a second phase of release of the prosthesis, characterized
by a single stroke of a full stroke prosthesis release
actuator.
[0027] The presently preferred embodiment of the invention features
a connection between the trigger and the slider which is
collapsible, to allow the slider to approach the trigger from any
position along its sliding length, without the need to actuate the
trigger at any point during withdrawal of the stent sheath. This is
conveniently accomplished by the provision of a collapsible line
having one end connected to the shaft of a windlass, and the other
end pulling on the sheath, the windlass reeling in the line, this
reeling in being accomplished by successive passes of a toothed
ratchet segment over the toothed circumference of a windlass drive
gear, each pass being achieved by a squeeze of the trigger.
Conveniently, the end of the line is connected to the slider. If
the slider itself is gripped by the medical practitioner, and urged
towards the windlass shaft, the line can collapse as the slider
approaches the windlass.
[0028] This invention relates to a connector portion useful
particularly, but not exclusively, as part of a device for passing
fluid into an annular cavity between an inner elongate body and an
outer elongate tubular body of a stent delivery system, and also
relates to a stent delivery system making use of the same
connector. In particular, but not exclusively, this invention
relates to a connector which comprises the male portion of a luer
connector. Furthermore, it relates to a device having a housing
with a distal end, a proximal end and an off-axis end, wherein the
housing provides a seating at the distal end thereof for the
proximal end of an outer elongate tubular body which extends
distally from the housing along an axis of the housing extending
between the proximal and the distal ends, and wherein the distal
and off-axis ends define respective openings which are in fluid
communication with each other, and wherein the proximal end has a
lumen which enables an inner elongate body co-axially within the
outer tubular body to extend from the housing both distally and
proximally along the axis thereof. It relates as well to a stent
delivery system using the above-mentioned connector and device.
[0029] Another aspect of the invention relates to a stent delivery
system such as that described above and that enables the surgeon
both to lock the position of the inner catheter with respect to the
outer sleeve and to inject fluid into the annular cavity between
the inner catheter and the outer sleeve.
[0030] This object has been achieved by a simplified delivery
system using the same component both for locking the position of
the inner catheter with respect to the outer sleeve and for
injecting fluid such as radiopaque fluid into the cavity between
the inner catheter and the outer sleeve.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] The accompanying figures, referred to herein and
constituting a part hereof, illustrate preferred embodiments of the
present invention, and together with the description serve to
explain the principles of the invention.
[0032] FIG. 1 is a longitudinal mid-section through a hand-held
device in accordance with the present invention;
[0033] FIG. 2 is a schematic representation, seen from above, of
the core components of the FIG. 1 device, enabling the interaction
of the different components to be appreciated further;
[0034] FIG. 3 shows in cross-section a device having a locking and
release device attached thereto;
[0035] FIG. 4 is a longitudinal section through a stent delivery
system using the locking and release device of FIG. 3; and
[0036] FIG. 5 shows in cross-section another embodiment of the
locking and release device.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0037] The drawings are of a preferred embodiment of the invention
and FIG. 1 shows one half 12 of a molded housing of which the other
half lies above the plane of the drawing.
[0038] The two housing halves define, in an assembled state, a
track 14 in which can be laid the proximal end of a co-axial stent
delivery device having an outer tube 6. Track 14 is formed by
mating axial recesses in the two housing halves, resulting in a
semi-circular channel open to the upper end in FIG. 1 of the
housing.
[0039] The proximal end of the outer tube 16 carries a hub 18 which
is received within a yoke 20 of a slider 24 which itself runs on a
pair of rails 22. The rails 22 are not integral molded parts of the
housing and are held in place by advancing a first one of the rails
through a hole (not show in FIG. 1) and through fixing part 52 and
feed hole in slider 24 at the distal end of the housing and into
blind hole at fixing point 54 distal from the proximal end of the
housing. The distal end of the rail is then bonded to the housing
or fixing part 52 using an ultrasonic fusion technique. The two
housing halves are then assembled and the other one of the rails is
fed through another hole in the distal end of the other housing
half, inserted through a feed hole in the slider 24 and pushed into
another blind hole at fixing point 54. The distal end of the second
rail is also bonded to the housing using an ultrasonic fusion
technique. Instead of ultrasonically bonding the distal ends of the
rails 22 to the housing, they may equally well be adhesively bonded
thereto. Although not shown in FIG. 1, rails 22 may also be an
integral part of the housing 12. The length of the rails 22 may
extend along the entire length of the housing 12, but is at least
equal the axial length of the stent to be deployed.
[0040] The present inventors also contemplate to provide markers on
the rails, provided the housing is made of a transparent material,
and on the slider to indicate the length of proximal withdrawal of
the outer tube 16 with respect to the position of the stent. If,
for example, a marker on the slider 24 lines up with a
proximal-most marker provided on one of the rails 22, this gives
the medical practitioner an indication that the stent has been
fully released. The slider 24 protrudes to the outside of the
housing 12 at the lower end thereof in FIG. 1, enabling a person to
manually urge the slider 24 along the length of the rails 22, when
appropriate. The protrusion length of the slider 24 may
conveniently be sufficient to be grasped by the thumb and the index
finger for optimum handling of the slider.
[0041] The inner element 26 of the co-axial delivery device is a
rod, or hypo-tube, or like element which extends proximally along
the track 14 to a proximal hub 28 which is captivated within the
proximal end of the housing 12 and so cannot move proximally or
distally once the co-axial delivery device is set within the track
14. Since the opposite end of the rod 26, that is, its distal end,
is normally defining the proximal end of the stent to be delivered,
the length of the rod 26 defines the distance separating the
proximal end of the housing 12, where the hub 28 is captivated, and
the proximal end of the stent being delivered. Hub 28 is clipped
into engagement with the housing at fixing point 29. Other ways of
attaching hub 28 to the proximal end of housing 12 are contemplated
and are obvious to those skilled in the art, such as a yoke.
[0042] The body 12 contains actuating elements to draw the slider
24 in a controlled way from the distal end of the rails 22 towards
their proximal ends. This proximal sliding movement draws hub 18
proximally, and so draws outer tube 16 of the delivery device
proximally. Such a movement would be useful, for example, to
release a self-expanding stent from within the distal portion of
the tube 16.
[0043] To effect a controlled proximal movement of the slider 24, a
collapsible line in the form of a pull wire 30 runs from the slider
24 to a windlass or take-up reel shaft 32 which is adjacent a
trigger 34 mounted to the housing 12. The reel shaft 32 carries a
toothed gear 35, and the teeth engage with complementary teeth 36
on an elongate ratchet element 38 itself pivotably mounted at an
axis 40 to the trigger 34. The trigger 34 is mounted in a recess
within the housing 12 and is held in place as soon as the two
housing halves are assembled.
[0044] Trigger 34 is biased to a rest position as shown in FIG. 1
by a leaf spring 46 which is pivotally mounted to the housing 12 at
a mounting pin 48. One end 47 of the leaf spring 48 cooperates with
the elongate ratchet means 38 and is movable thereon. The other
end, beyond mounting point 48 bears against support 49 and is free
to move thereon. Between the pivot 48 and the distal end of leaf
spring 46 making contact with the ratchet element 38, the wire used
for the leaf spring is turned into a helical spring 56. The helical
spring serves for optimizing the spring-characteristic forces
bearing on the ratchet element 38. From portion 56 which
establishes the helical spring, the leaf spring essentially follows
the contour of the interior of the trigger until another helically
turned portion follows, wrapping around the mounting pin 48. At
this point, the leaf spring is pivotally mounted to the housing.
Thus, when pushing the trigger 34 upwards, the support 49 resists
pressure from one end of the spring 46, while the other end of leaf
spring 46 making contact with ratchet element 38 is free to follow
the movement of the trigger 34. Subsequent to actuation of the
trigger, leaf spring reaction on support 49 urges trigger 34 to its
rest position while maintaining contact with the ratchet element
38.
[0045] Successive pumps on the trigger 34 to move the trigger
upwards in FIG. 1, against the bias of leaf spring 46, cause
successive corresponding passes of the ratchet element 38 across
the rotational axis 42 of the take-up reel shaft 32, causing the
shaft 32 to rotate clockwise, as shown in FIG. 1. Movement of the
trigger 34 upwards cause distal end 47 of leaf spring 46 to slide
along the surface of ratchet means 38, never losing contact
therewith. Thus, a force constantly applied on the ratchet element
38 by the leaf spring 46 urges ratchet element into engagement with
the toothed gear 35, so that controlled proximal withdrawal of
outer tube 16 if achieved without the risk of no-load operation of
the trigger 34. Note how the end 47 of leaf spring 46 remote from
its mounting point 48 urges the ratchet element 38 into contact
with windlass gear wheel 35, but nevertheless allows the ratchet
element 38 to return to its start position with the downward
movement of the trigger 34. The trigger 34 and ratchet element 38
are helped to return to their original dispositions by the bias
spring 46 acting on the trigger 34. Helical spring portion 56 of
leaf spring 46 rests on the interior surface of trigger 34, as
shown in FIG. 1.
[0046] FIG. 1 also shows pivot axis of trigger 34 at pivot point
41. By pushing trigger upwards, trigger slightly rotates around
axis 41, thereby moving ratchet element 38 connected with trigger
34 at mounting point 40 upwards and causing windlass gear 35 to
rotate clockwise. This clockwise rotation of windlass gear 35
causes pulling on line 30 moving hub 18 and therewith outer tube 16
proximally, resulting in deployment of the stent at the distal end
of the coaxial stent delivery device.
[0047] A pawl 44 is mounted to the housing 12, and engages
successive teeth of the take-up gear 35, to prevent any
anti-clockwise return movement of the reel 32 as the ratchet
element 38 returns to its initial position.
[0048] However, pumps on the trigger 34 are not the only way to
bring the slider 24 proximally along the rails 22. As mentioned
earlier, one can manually grip the slider 24 and urge it proximally
along the rails 22, without any contact at all with the trigger 34.
In this case, either the pull wire 30 becomes loose and meanders
within the housing 12 (that is to say, it collapses), or else, by
the provision of a suitable wind-up mechanism or spring (not shown)
on the take-up reel 32, any relief of tension in the wire 30 is met
with a corresponding clockwise rotation of the reel 32, to take up
any slack in the wire 30. Either way, the person delivering the
stent has the option of pumping on the trigger 34, or pulling on
the slider 24.
[0049] The hub 18 is provided with a fluid inlet port 50 in the
form of a luer lock. This is useful for injecting radiopaque fluid
into the bodily lumen which is to be stented for the reason
explained above. The luer lock, modified accordingly, is also used
to fix the axial position of outer tube 16 in the event the medical
practitioner needs to interrupt the release operation of the
stent.
[0050] FIG. 2 is a schematic representation in plan of the device
shown in FIG. 1. FIG. 2 shows how line 30 is wound around the
windlass gear shaft 32. The winding of line 30 may be achieved by a
spring-biased (not shown) reel which reels in any slack in line 30
automatically upon proximal movement of slider 24. According to
FIG. 2, the shaft 32 can be formed as a drum flanked at each end by
a gear wheel 35, each wheel having its own ratchet element 38, both
pivotally mounted to the trigger 34. This assists management of the
reeling in of the pull wire 30.
[0051] The above description is of a device to fit at the proximal
end of a coaxial catheter device for percutaneous transluminal
stent delivery. In such systems, it is customary to provide a hub
at the proximal end of the two coaxial elements of the system. What
is contemplated is that the present device will engage with these
two hubs, and allow the usual range of connections to be made to
each of the hubs. Thus, for example, it is to be expected that a
guide wire will extend proximally from the hub at the proximal end
of the inner element of the coaxial system, that the hub of the
outer sheath will seal with the inner coaxial element and that it
will also have a port arrangement for the admission or withdrawal
of liquids from the annular space between the two coaxial elements
of the system.
[0052] It is the intention that the above described system should
have wide application to different stent delivery systems, this
being facilitated by provision of easily exchangeable engagement
formations in the housing for the respective hubs.
[0053] For ease of use, it is contemplated that the housing would
display identical left and right sides, a lower edge with the
trigger in it, and an upper edge in which the track for receipt of
the coaxial stent delivery element is open-topped, so that the
stent delivery system can be laid into a recess in the top edge of
the housing which extends all the way from one end of the housing
to the other. Those skilled in this art will be able to envisage
other arrangements.
[0054] By providing the trigger 34 with different bores, to mount
it on the housing at several different locations relative to the
ratchet element 38, a choice of different strokes can be offered,
to achieve a desired length of withdrawal of outer sleeve 16 for
each stroke of the trigger.
[0055] The formation which receive hubs 18 and 28 can be made in
the form of resilient clips, so that a variety of different
delivery systems can be laid into the track 14.
[0056] In fact, the device is designed with flexibility in mind, to
enable its use with a range of delivery devices and a range of user
characteristics. The housing is deliberately designed symmetrical,
that is, not "handed", so it is equally suitable for left-handed
and right-handed use.
[0057] A stopper may be provided on rails 22 as an indicator or
reminder for the medical practitioner that a certain stent length
has been deployed and to continue the deployment procedure by
manually moving the slider 24 proximally on the rails 22. The
stopper may be removed or it may be in the form of a discontinuity
on the surface of the rails 22, offering a resistance to slider
travel that may easily be overcome manually when continuing the
deployment procedure by moving the slider 24 proximally. This
provides tactile feedback to the surgeon giving him/her assurance
that the stent has been fully deployed.
[0058] The materials used for the manufacture of the stent delivery
device are, but not limited to, polyoxymethylene (POM),
polycarbonate (PC) and other polymer compositions conventionally
used for molding medical devices. Other components, such as the
rails and the leaf spring, are made from metal suitable for medical
instruments, such as stainless steel with designation 1.4310 or
1.4301. Other materials will be known and readily available to
those skilled in the art.
[0059] Line 30 is a multifilament polymer-based fiber which gives
line 30 greater flexibility than a monofilament line is likely to
deliver. This flexibility is important when slider is moved
proximally releasing tension in the line which then meanders within
the housing.
[0060] FIG. 3 shows a cross-sectional view of a device for passing
fluid into an annular cavity 130 of a housing of the device (which
takes the form of a T-piece 2) and also between an inner catheter
126 and an outer sleeve 128.
[0061] The device has a housing in the shape of a T-piece 2
comprising a distal end 124, a proximal end 112 and an off-axis end
136. A lumen 123 extends between the proximal and distal ends, and
is in fluid communication with a lumen 131 in the side branch of
the T-piece which leads to the off-axis end 136. It is the distal
124 and the proximal 112 which define the axis of the device. The
outer sleeve 128 of a stent delivery system is attached to the
threaded distal end 124 of the device via a threaded female collar
122. The female collar 122 comprises a central through-hole through
which the outer sleeve 128 is inserted and thermally clamped to the
female collar 122. By "thermal clamping" is meant that the material
of the proximal end of the outer sleeve 128 expands upon
thermo-forming heat treatment and retains its expanded shape when
it returns back to ambient temperature. Hence, the
radially-expanded proximal end of the outer sleeve 128 resists
distal movement of the outer sleeve relative to the collar 122 when
the process of thermal treatment is completed. It is also
conceivable to use other means to attach the outer sleeve 128 to
the distal end of the device, such as a press-fitting using
re-entrant surfaces, or suitable adhesives. A seating 125 of the
housing seals with a complementary seating 127 of the threaded
collar 122.
[0062] The proximal end 112 of the device, as shown in FIG. 3
exhibits a recess having two different diameters whereby the
innermost recess 114 in an axial direction accommodates an O-ring
118 for providing a fluid-tight seal with an inner catheter 126 and
a plug 120 press-fitted into the larger diameter recess 116 in
order to prevent the O-ring from slipping out of the smaller recess
upon proximal movement of the inner catheter 126. It is also
conceivable to screw the plug into the larger diameter recess or
use an appropriate adhesive. Differently sized O-rings can be used
to accommodate differently sized inner catheters for differently
sized stents. This further enhances the versatility of the
device.
[0063] The off-axis end 36 of the device shows a female luer-lock
element 133 which connects to a male luer-lock assembly 132 thereby
to serve as the locking and release device 11. Thus, the locking
and release device 11 may also be recognized to be based on a
luer-lock connector. It comprises a passage 138 therethrough for
passing fluid down the inner bore of the luer connector. The inner
end of the male luer connector 132, which extends into the off-axis
end of the T-piece 2, comprises a spigot 6 which is coaxial with,
and located within, the internal bore 138 of the luer connector.
The spigot 6 is fixed inside the bore 138 of the luer connector.
The spigot 6 is fixed inside the bore 138 of the luer connector by
means of an annular cutting edge which cuts itself into the
material of the luer connector (in the manner of a self-tapping
screw) and thereby fixedly fastens the spigot 6 to the luer
connector 1. It is also conceivable to screw or press-fit the
spigot into the luer connector. The spigot 6 comprises a cut-out
portion 140 at the end extending into the T-piece for providing a
continuous passage for the fluid to be injected that is to say,
fluid communication between the bore 138 and the lumen 123. The
lower (in FIG. 3) end of the spigot 6 comprises a re-entrant
surfaces onto which an elastically deformable elongate locking
member 8 is attached. The locking member 8 is made out of silicone
rubber but other materials can be used. The end surface of the
locking member 8, remote from the spigot 6, constitutes a pressure
pad which bears on the inner catheter 126 when the locking member
is in its locking disposition, as explained below.
[0064] A distinct feature of the luer connector is its quick and
easy installation, since it requires only less than half a turn to
fully engage the male luer-lock connector 132 with the female
portion 133 of the mating luer-lock on the off-axis side branch of
the T-piece. The dimensions of the spigot 6 and the pressure pad 8
are such that, when bringing the male luer-lock connector 132 into
full engagement with the female element 133, the deformable locking
member 8 extends sufficiently far enough beyond the end of the
luer-lock connector so that it experiences a compressive force due
to pressing down onto the inner catheter 126. This means that, in
the absence of the inner catheter 126, the elastic member
intersects the locus or line of presence of the inner catheter, so
that it undergoes deformation when such inner body is present. It
is this compression of the locking member which prevents axial
sliding movement of the inner catheter within the device. In this
locking disposition, fluid can still be injected through the
luer-lock connector down into the T-piece lumen 123 and thereafter
the annular cavity 130 between the inner catheter 126 and the outer
sleeve 128. For ease of use, a syringe can easily be attached to
the upper end 139 of the male luer-lock element 132, that is, the
end opposite the one being connected to the T-piece of the luer
connector via a luer-lock connection, which upper ends 139 for this
purpose can exhibit the characteristic cone angle of a female
luer-lock portion.
[0065] The luer connector optionally comprises a safety catch which
prevents inadvertent release of the male luer connector 132 from
the T-piece 2. The safety catch illustrated comprises two portions,
namely a portion 134 located on the male luer connector 132 and
preferably glued thereon and a portion 135 on the female luer
portion 133 and preferably glued to it. Between the portions 134,
135 is a frangible neck 137, which prevents rotation of the luer
connector until it is broken by relative rotation of the male and
female luer-lock portions. To release the safety catch, the luer
connector is rotated counter-clockwise thereby breaking the
frangible neck 137. The safety catch is conveniently made of
polymeric material. It is also conceivable to bring a pawl into
engagement with a spring-biased toothed annulus on the housing 2
close to the off-axis end of the T-piece. To disengage the safety
catch, the spring-biased toothed annulus is pushed towards the
T-piece, thereby releasing the pawl and disengaging the luer
connector. Also, a shear pin for blocking the rotation of the luer
connector until it is broken in shear, or any other conventional
locking mechanism that is suitable in size and weight can be
used.
[0066] The entire structure is conveniently made out of synthetic
polymeric materials.
[0067] FIG. 4 shows a perspective view of the stent delivery system
as described in connection with FIGS. 1 and 2 using the locking and
release device as well as the T-piece of FIG. 3 in an assembled
state. The delivery system 170 is based on a trigger-principle for
the proximal withdrawal of the outer sleeve with respect to the
inner catheter. The proximal and distal end of the T-piece
connector are engaged with mating parts of the delivery system,
whereby the proximal ends 150 of the inner catheter 126 is fixed in
position by a mount 152 at the rear side of the trigger device.
Upon actuation of the delivery system the T-piece is drawn
rearwardly by a tension wire 172 and carriage 174, with successive
squeezes of a trigger 154, that reel in the wire 172 on a capstan
drum 176 which the trigger rotates through a rack 178. The carriage
174 carries the luer-lock housing 2 towards the rear mount 152
step-wise, with each squeeze of the trigger 154, and thereby
withdraws the outer sheath 128 to gradually release the stent.
[0068] During insertion of the stent into the delivery system,
sterilization and transport, the luer-lock connector remains in its
locking disposition, thereby preventing inadvertent sliding
movement of the inner catheter with respect to the outer sleeve. It
is only shortly before deploying the stent into the body lumen,
that the luer-lock connector 1 is disengaged from the T-piece 2.
Once the stent has been properly placed at the site of the
stenosis, the surgeon uses the trigger mechanism in order to
proximally withdraw the outer sleeve and to release the stent. In
case the surgeon has to temporarily interrupt the procedure of
stent placement, the luer-lock connector ca be inserted back into
the T-piece in order to fix the position of the inner catheter with
respect to the outer sleeve.
[0069] FIG. 5 shows in cross-section another embodiment of the
locking and release device 1 in FIG. 3. It connects to the female
luer-lock element 133 at the off-axis end 136 of the device shown
in FIG. 1 and comprises a passage therethrough (not shown) for
passing fluid down the inner bore of the luer connector 1, into
lumen 123 of the T-piece connector 2.
[0070] The inner end of the locking and release device 1 which
extends into the off-axis end of the T-piece 2 comprises a metal
pin 180 which is coaxial with, and located within, the internal
bore (not shown) of the luer connector. The metal pin 180 is fixed
inside the bore of the luer connector by means of a press-fit. The
end of the metal pin extending into the off-axis end of the T-piece
is domed. The end surface of metal pin curves radially inwardly,
uniformly from all radial directions. This dome-shape of the axial
end of metal pin 180 effects line contact the annular edge 182 of
metal pin 180 with the inner catheter 126. The dome-shaped end of
metal pin 180 is also more clearly shown in the blown-up part of
FIG. 5.
[0071] For providing fluid communication between the inner bore of
the luer connector 1 and lumen 123 of T-piece 2, the upper portion
of metal pin in FIG. 5 to be inserted into the off-axis end of
T-piece is oblate. When the metal pin is inserted into the male
Luer connector, a gap remains between the oblated portion 185 of
metal pin and the end portion of the luer connector defining the
inner bore. This way, fluid connection between inner bore 138 of
luer connector 1 and inner lumen 123 of T-piece is established.
[0072] The press-fit of metal pin into male luer connector is
ensured by the chamfered portion 184 of metal pin. A flange 186
serving as a stopper is provided on the metal pin. The flange also
takes up any compressive stresses caused by the pushing of the pin
onto the inner catheter.
[0073] To prevent inadvertent rotation of the male luer-lock
connector 1 with respect to the T-piece, an integrally molded
element is both attached to the luer connector and the off-axis end
of the T-piece. This element comprises portion 134, which
circumferentially surrounds the near end of the luer connector to
the off-axis end of the T-piece, a frangible portion 137 and
portion 135 circumferentially surrounding a section of the off-axis
end of the T-piece. Arrows are provided on portion 134 indicating
the medical practitioner what direction to turn the luer connector
in order to release it from the T-piece.
[0074] Upon rotation of the luer male connector 1, frangible
portion 137 breaks off portion 135, thereby allowing the luer
connector to be detached from the T-piece. The frangible portion
137 is designed such that it resists inadvertent rotation of the
luer connector prior to use of the luer connector/T-piece assembly.
It also serves as an indicator for the surgeon to indicate that the
device shown in FIG. 3 has not been previously used in a surgical
procedure, and sterility is still maintained.
[0075] The circular edge 182 of dome-shaped end of metal pin 180,
in an assembled state of the device shown in FIG. 1, bites on the
inner catheter 126 and prevents distal or proximal movement of the
inner catheter with respect to the T-piece. The inventor of the
present application have found that it is the sharp edge of metal
pin 180 that effectively prevents this movement of the inner
catheter. Preferably, the diameter of the 360.degree. circular edge
equals the diameter of the inner catheter 126. It is also
contemplated that the material used for the metal pin should be
harder than the material used for the inner catheter.
[0076] Although the illustrated embodiment shows a single T-piece
being used for both introduction of radiopaque marker fluid and for
clamping the inner catheter relative to the outer sheath, and
although this is a useful advantage of the invention, nevertheless,
it will be appreciated that separate T-pieces could be used for
these two separate functions. The advantage delivered by this
invention, namely reliable and economical inner catheter clamping
remains, even if radiopaque fluid is delivered elsewhere.
* * * * *