U.S. patent application number 17/841926 was filed with the patent office on 2022-09-29 for implant delivery system with braid cup formation.
This patent application is currently assigned to DePuy Synthes Products, Inc.. The applicant listed for this patent is DePuy Synthes Products, Inc.. Invention is credited to Lacey GOROCHOW.
Application Number | 20220304699 17/841926 |
Document ID | / |
Family ID | 1000006402518 |
Filed Date | 2022-09-29 |
United States Patent
Application |
20220304699 |
Kind Code |
A1 |
GOROCHOW; Lacey |
September 29, 2022 |
IMPLANT DELIVERY SYSTEM WITH BRAID CUP FORMATION
Abstract
An implant system presented herein includes an engagement wire,
a pull wire, and a braided implant having a distal ring thereon.
The engagement wire has an elongated member with a radially
extending engagement feature at its distal end. The braid can be
moved from a delivery shape sized to traverse a catheter to an
implanted shape sized to occlude an aneurysm neck. When the braid
is in the delivery shape, the pull wire and the elongated member
extend through the distal ring and the engagement feature is in a
distal direction in relation to the distal ring. Once at least a
portion of the braid is positioned in the aneurysm, the pull wire
and the elongated member can be moved in a proximal direction to
engage the engagement feature to the distal ring and move the
distal ring proximally, thereby reshaping the braid within the
aneurysm.
Inventors: |
GOROCHOW; Lacey; (Miami,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DePuy Synthes Products, Inc. |
Raynham |
MA |
US |
|
|
Assignee: |
DePuy Synthes Products,
Inc.
Raynham
MA
|
Family ID: |
1000006402518 |
Appl. No.: |
17/841926 |
Filed: |
June 16, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
16686361 |
Nov 18, 2019 |
11376013 |
|
|
17841926 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00323
20130101; A61B 2017/00867 20130101; A61B 17/12172 20130101; A61B
17/12113 20130101; A61B 2017/12054 20130101; A61B 2090/3966
20160201 |
International
Class: |
A61B 17/12 20060101
A61B017/12 |
Claims
1. A method for configuring an implant comprising a distal ring and
a tubular braid for delivery, the method comprising: positioning
the distal ring of approximate a distal end of the tubular braid;
positioning an engagement feature to extend radially from a distal
end of an elongated member; extending the elongated member though a
lumen of the tubular braid and a lumen of the distal ring;
extending a pull wire through the lumen of the tubular braid and
the lumen of the distal ring such that the pull wire inhibits the
engagement feature from passing through the lumen of the distal
ring; retracting the engagement feature in a proximal direction to
secure the implant within an aneurysm; retracting the pull wire in
a proximal direction from the implant; retracting the engagement
feature in a proximal direction from the implant such that the
implant is disengaged from at least the pull wire and the
engagement feature; and disengaging the implant from a delivery
tube.
2. The method of claim 1, further comprising: positioning the
implant with the elongated member and the pull wire therethrough
within a delivery catheter such that the engagement feature is
positioned in a distal direction in relation to the distal
ring.
3. The method of claim 1, further comprising: attaching a proximal
ring to a proximal end of the tubular braid; and extending the
elongated member and the pull wire through a lumen of the proximal
ring.
4. The method of claim 3, further comprising: attaching a
detachment feature to the proximal ring; and detachably attaching
the detachment feature to a delivery tube.
5. The method of claim 4, further comprising: positioning the
detachment feature in a notch at a distal end of the delivery
tube.
6. The method of claim 4, the method further comprising: attaching
a loop wire to the delivery tube; extending the loop wire through
an opening of the detachment feature; and extending at least the
pull wire or an elongated member through an aperture of the loop
wire.
7. The method of claim 3, further comprising: engaging a distal end
of a hollow push rod to the proximal ring such that the hollow push
rod is configured to disengage the proximal ring during
treatment.
8. A method for positioning an implant, the method comprising:
positioning the implant comprising a distal ring thereon within a
delivery catheter; positioning a pull wire and an elongated member
with an engagement feature thereon through a lumen of the distal
ring such that the engagement feature is positioned in a distal
direction in relation to the distal ring and such that the pull
wire inhibits the engagement feature from passing through the lumen
of the distal ring; extending the implant through a neck of an
aneurysm; reshaping the implant within the aneurysm by retracting
the elongated member while the pull wire is extended through the
distal ring, causing the engagement feature to engage the distal
ring and move the distal ring proximally; retracting the pull wire
in a proximal direction from the implant; retracting the engagement
feature in a proximal direction from the implant such that the
implant is disengaged from at least the pull wire and the
engagement feature; and disengaging the implant from a delivery
tube.
9. The method of claim 8, further comprising: securing the implant
within the aneurysm.
10. The method of claim 8, further comprising: engaging the
delivery tube to the implant; positioning the delivery tube, the
implant, the pull wire, and the elongated member within the
delivery catheter; and moving the implant distally through the
delivery catheter by pushing the delivery tube distally.
11. The method of claim 10, further comprising: disengaging the
delivery tube from the implant by first retracting the pull wire
and then the elongated member from an opening in a loop wire
attached to the delivery tube thereby allowing the loop wire to
disengage the implant.
12. The method of claim 8, further comprising: positioning the
delivery tube in a proximal direction in relation to a proximal
ring, the proximal ring disposed approximate a proximal end of the
implant, wherein the delivery tube is a hollow push rod;
positioning the pull wire and the elongated member within a lumen
of the hollow push rod and within a lumen of the proximal ring;
pushing the hollow push rod in a distal direction against the
proximal ring, thereby moving the implant distally through the
delivery catheter; maintaining the proximal ring within the
delivery catheter while the implant is extended through the neck of
the aneurysm and while the implant is reshaped by retracting the
elongated member while the pull wire is extended through the distal
ring; engaging the hollow push rod to the proximal ring while the
implant is reshaped by retracting the elongated member while the
pull wire is extended through the distal ring; retracting the pull
wire in the proximal direction from the distal ring to remove the
pull wire from the lumen of the distal ring; retracting the
engagement feature in the proximal direction through the distal
ring while the pull wire is removed from the distal ring;
retracting the pull wire in the proximal direction through the
proximal ring; retracting the engagement feature in the proximal
direction through the proximal ring; and retracting the hollow push
rod in the proximal direction, thereby disengaging the hollow push
rod from the proximal ring.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional application claiming
priority under 35 U.S.C. .sctn. 121 to U.S. patent application Ser.
No. 16/686,361, filed 18 Nov. 2019, and published as U.S. Patent
Application No. US2021/0145449 on 20 May 2021, the contents of
which are incorporated herein by reference as if fully set
forth.
FIELD OF INVENTION
[0002] The present invention generally relates to medical
instruments, and more particularly, to implant system for aneurysm
therapy.
BACKGROUND
[0003] The invention relates generally to medical devices and more
particularly to implant systems and methods for treating vascular
defects. For example, the invention can relate to implant systems
and methods for treating an aneurysm. Aneurysms are dilations in a
blood vessel caused from weakening of a blood vessel wall. The
dilation is produced by the pressure exerted by normal blood flow,
which can cause the weakened segment of the blood vessel to swell.
In some cases, this swelling results in a sac, or balloon-like
polyp protruding from the main or parent vessel. Continued growth
and/or eventual rupture of the ballooned arterial wall can have
devastating results for a patient. As such, unruptured aneurysms
should be treated to prevent hemorrhage. Additionally, ruptured
aneurysms can be treated to avert a subsequent rupture and/or
additional damage.
[0004] Some known medical devices and treatment methods used for
treating an aneurysm include packing one or more embolic coils into
the sac of the aneurysm. In some treatments, a platinum embolic
coil is electrolytically separated from a delivery wire, thus
inducing a charge in the coil which can cause a thrombotic effect
in the aneurysm. However, the use of electricity for separating the
coil from the delivery system is not desirable for patients with
pacemakers or similar devices. In other treatments, embolic coils
are mechanically separated from a delivery tube. Unfortunately,
recanalization is a common problem in known procedures, meaning
blood flow returns to the aneurysm and can cause the coil-packed
aneurysm to swell further. Additionally, such known devices and
methods require prolonged procedure times for the patient and
correspondingly increased exposure to radiation for the patient.
Moreover, such devices and methods do not treat the neck of the
aneurysm, which is the area between the stem blood vessel and the
sac of the aneurysm.
[0005] Another known treatment method includes the use of both
embolic coils and a stent. The coils are delivered to the sac of
the aneurysm as described above, and the stent is positioned within
the parent blood vessel such that a portion of the stent is
disposed over the neck of the aneurysm. A stent is often required
for treating wide-neck aneurysms to inhibit the embolic coils from
protruding into the parent blood vessel. Such procedures have
several drawbacks. For one, delivery of two separate types of
devices (i.e., coils and a stent) is a more complex procedure,
often resulting in a longer procedure time for the patient. The
stent may lead to intra-stent stenosis of the blood vessel.
Additionally, a patient would likely be required to take a blood
thinner indefinitely following the procedure. Moreover, such
devices and methods are not suitable for treatment of aneurysms
positioned at a bifurcation of the blood vessel (i.e., between
adjacent branches of a vessel).
[0006] Another known device and treatment method includes the use
of a flow diverter delivered to the stem blood vessel adjacent the
neck of the aneurysm. Most commonly, the flow diverter is
positioned within the parent blood vessel over the neck of the
aneurysm to prevent additional blood flow into the aneurysm from
the vessel. In current procedures, typically, more than one flow
diverter is required per aneurysm to ensure blood flow is
appropriately diverted from the aneurysm. Such a device and
treatment method has similar drawbacks to the use of a stent,
described above. Specifically, the flow diverter may lead to
stenosis of the blood vessel and the patient would likely be
required to take a blood thinner indefinitely following the
procedure. Additionally, many known flow diverters are not suitable
for treating an aneurysm positioned at a bifurcation of the blood
vessel. Moreover, long term follow-up of patients treated using a
flow diverter is showing an increased rate of recanalization to the
aneurysm.
[0007] Thus, there is a need for improved systems, devices, and
methods for treating vascular defects, such as balloon-type
aneurysms, as described herein.
SUMMARY
[0008] It is an object of the present invention to provide systems,
devices, and methods to meet the above-stated needs.
[0009] An example implant system can have an engagement wire, a
pull wire, and an implant having a distal ring thereon such that
the engagement wire and pull wire are configured to engage the
distal ring to reshape the implant and disengage the distal ring
after the implant is reshaped. The engagement wire can have an
elongated member and an engagement feature disposed at a distal end
of the elongated member. The implant can have a braid movable from
a delivery shape sized to traverse a catheter to an implanted shape
sized to occlude an aneurysm neck. The distal ring can be affixed
to the braid. When the braid is in the delivery shape, the pull
wire and the elongated member can extend through the distal ring
and the engagement feature can be in a distal direction in relation
to the distal ring. The pull wire and the elongated member can be
movable in a proximal direction to thereby engage the engagement
feature to the distal ring and move the distal ring proximally. The
braid can be movable from the delivery shape to the implanted shape
upon a proximal movement of the distal ring.
[0010] In some examples, the implant can also include a proximal
ring affixed to the braid. When the braid is in the delivery shape,
the pull wire and the elongated member can extend through the
proximal ring and the proximal ring can be positioned in the
proximal direction in relation to the distal ring.
[0011] In some examples, the implant system can include a delivery
tube detachably attached to the implant. The system can include a
loop wire affixed to the delivery tube. The implant can include a
detachment feature having an opening therethrough. The loop wire
can be extended through the opening in the detachment feature. One
or both of the pull wire and the elongated member can extend
through the loop wire to inhibit the loop wire from exiting the
opening in the detachment feature. In examples wherein the pull
wire extends through the loop wire, the pull wire can be movable to
exit the loop wire. Additionally, or alternatively, in examples
wherein the elongated member extends through the loop wire, the
elongated member and the engagement feature can be moveable to exit
the loop wire. The loop wire can be movable to exit the opening in
the detachment feature when both of the pull wire and the elongated
member are free from the loop wire.
[0012] In some examples, the delivery tube can include a notch near
its distal end. The detachment feature can be positioned within the
notch. The detachment feature can be asymmetric about one or more
axis.
[0013] In some examples, the implant system can include a hollow
push rod configured to engage the proximal ring of the implant. The
hollow push rod can be used to translate the implant distally, in
place of, or in addition to the delivery tube and detachment
feature. The hollow push rod can have an inner diameter that is
greater than a sum of a diameter of the pull wire and a diameter of
the elongated member. The engagement feature can have a diameter
that is less than an inner diameter of the distal ring to allow the
engagement feature to pass through the distal ring. The inner
diameter of the distal ring can be greater than a sum of a diameter
of the pull wire and a diameter of the elongated member so that
both the pull wire and the elongated member portion of the
engagement wire can pass through the distal ring. The inner
diameter of the distal ring can be less than the sum of the
diameter of the pull wire and the diameter of the engagement
feature such that the engagement feature is inhibited from passing
through the distal ring when both the pull wire and the elongated
member are extended through the distal ring.
[0014] An example method for configuring an implant having a distal
ring and a tubular braid for delivery can include one or more of
the following steps presented in no particular order, and the
method can include additional steps not included here. The method
can include positioning the distal ring of the implant on a distal
end of the tubular braid. Further, an engagement feature can be
positioned to extend radially from a distal end of an elongated
member. The elongated member can be extended though a lumen of the
tubular braid and a lumen of the distal ring. Further, a pull wire
can be extended through the lumen of the tubular braid and the
lumen of the distal ring such that the pull wire inhibits the
engagement feature from passing through the lumen of the distal
ring. The method can further include retracting the engagement
feature in a proximal direction to secure the implant within an
aneurysm. The pull wire can be retracted in a proximal direction
from the implant. Further, the engagement feature can be retracted
in a proximal direction from the implant such that the implant is
disengaged from at least the pull wire and the engagement feature,
and disengaging the implant from a delivery tube. The method can
further include positioning the implant with the elongated member
and the pull wire therethrough within a delivery catheter such that
the engagement feature is positioned in a distal direction in
relation to the distal ring. A proximal ring can be attached to a
proximal end of the tubular braid, and the elongated member and the
pull wire can be extended through a lumen of the proximal ring.
[0015] In some examples, the method can further include attaching a
detachment feature to the proximal ring, detachably attaching the
detachment feature to a delivery tube, and positioning the
detachment feature in a notch at a distal end of the delivery tube.
The method can also further include attaching a loop wire to the
delivery tube, extending the loop wire through an opening of the
detachment feature, and extending at least the pull wire or an
elongated member through an aperture of the loop wire.
Additionally, or alternatively, the method can include engaging a
distal end of a hollow push rod to the proximal ring such that the
hollow push rod is configured to disengage the proximal ring during
treatment.
[0016] An example method for positioning an implant can include one
or more of the following steps presented in no particular order,
and the method can include additional steps not included here. The
method can include positioning the implant comprising a distal ring
thereon within a delivery catheter. Further, a pull wire and an
elongated member with an engagement feature thereon can be
positioned through a lumen of the distal ring such that the
engagement feature is positioned in a distal direction in relation
to the distal ring and such that the pull wire inhibits the
engagement feature from passing through the lumen of the distal
ring. Further, the implant can extend through a neck of an
aneurysm. The method can further include reshaping the implant
within the aneurysm by retracting the elongated member while the
pull wire is extended through the distal ring. This causes the
engagement feature to engage the distal ring and move the distal
ring proximally. Further, the pull wire can be retracted in a
proximal direction from the implant. The method can further include
retracting the engagement feature in a proximal direction from the
implant such that the implant is disengaged from at least the pull
wire and the engagement feature, and disengaging the implant from a
delivery tube.
[0017] In some examples, the method can further include engaging
the delivery tube to the implant, positioning the delivery tube,
the implant, the pull wire, and the elongated member within the
delivery catheter, and moving the implant distally through the
delivery catheter by pushing the delivery tube distally. The method
can further include disengaging the delivery tube from the implant
by first retracting the pull wire and then the elongated member
from an opening in a loop wire attached to the delivery tube
thereby allowing the loop wire to disengage the implant.
Additionally, or alternatively, the method can further include
positioning the delivery tube in a proximal direction in relation
to a proximal ring, the proximal ring disposed approximate a
proximal end of the implant, wherein the delivery tube is a hollow
push rod. Further, the pull wire and the elongated member can be
positioned within a lumen of the hollow push rod and within a lumen
of the proximal ring. The method can further include, pushing the
hollow push rod in a distal direction against the proximal ring,
thereby moving the implant distally through the delivery catheter.
Further, the proximal ring can be maintained within the delivery
catheter while the implant is extended through the neck of the
aneurysm and while the implant is reshaped by retracting the
elongated member. Further, the elongated member can be retracted
while the pull wire is extended through the distal ring. The method
can further include engaging the hollow push rod to the proximal
ring while the implant is reshaped by retracting the elongated
member while the pull wire is extended through the distal ring.
Further, the pull wire can be retracted in the proximal direction
from the distal ring to remove the pull wire from the lumen of the
distal ring. The method can further include retracting the
engagement feature in the proximal direction through the distal
ring while the pull wire is removed from the distal ring. Further,
the pull wire can be retracted in the proximal direction through
the proximal ring. The method can further include retracting the
engagement feature in the proximal direction through the proximal
ring, and retracting the hollow push rod in the proximal direction,
thereby disengaging the hollow push rod from the proximal ring.
[0018] In some examples, the method can further include securing
the implant within the aneurysm.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The above and further aspects of this invention are further
discussed with reference to the following description in
conjunction with the accompanying drawings, in which like numerals
indicate like structural elements and features in various figures.
The drawings are not necessarily to scale, emphasis instead being
placed upon illustrating principles of the invention. The figures
depict one or more implementations of the inventive devices, by way
of example only, not by way of limitation.
[0020] FIG. 1 is an illustration of a system deploying within a
cross-section of an aneurysm according to aspects of the present
invention;
[0021] FIGS. 2A to 2C are illustrations of an exemplary distal end
of an implant and delivery system according to aspects of the
present invention;
[0022] FIGS. 3A and 3B are illustrations of a cut-away views of a
delivery system detaching from an implant in an exemplary system
according to aspects of the present invention;
[0023] FIG. 4 is an illustration of a cut-away view of an exemplary
system according to aspects of the present invention;
[0024] FIGS. 5A to 5C are illustrations of an exemplary implant in
a pre-determined state outside the aneurysm, an exemplary implant
in a deployed state within a cross-section of the aneurysm, and in
a deformed/delivery configuration, respectively, according to
aspects of the present invention;
[0025] FIGS. 6A to 6D are an illustration of a deployment sequence
of an exemplary system according to aspects of the present
invention;
[0026] FIGS. 7A and 7B are illustrations of a cross-section of an
exemplary system for deploying an exemplary implant into the
aneurysm according to aspects of the present invention;
[0027] FIG. 8 is a flow diagram outlining example method steps that
can be carried out during deployment of an exemplary implant
according to aspects of the present invention; and
[0028] FIG. 9 is a flow diagram outlining example method steps for
constructing an exemplary system according to aspects of the
present invention.
DETAILED DESCRIPTION
[0029] In general, example systems described herein can include an
implant having an expandable body with a distal ring thereon and a
delivery system configured to position and shape the implant in an
aneurysm. The implant can be a braid expandable from a deformed
configuration in which the implant is shaped to be delivered
through a microcatheter to an aneurysm treatment site to a deployed
configuration in which the implant is shaped to occlude an aneurysm
from within an aneurysm sac. The delivery system can include a pull
wire and an engagement wire configured to pass though the lumen of
the distal ring and the lumen of the braid. The pull wire and the
engagement wire can be retracted in tandem to move the braid to a
cup-shaped deployed configuration, thereby providing a mechanical
means to adjust the implant within the sac. The engagement wire can
have a bead or other such engagement feature at its distal end
sized to pass through the collar, and the pull wire can be sized
such that when both the pull wire and engagement wire are
positioned through the lumen of the distal ring, the engagement
feature is inhibited from passing through the distal ring. The
system can also be configured such that the pull wire and/or
engagement wire functions to mechanically release the implant from
the delivery system.
[0030] FIG. 1 depicts a cross-sectional view of an exemplary
system. As illustrated, the system can have an implant 100
detachably attached to a delivery system 200. The implant 100 can
have a braid 110, a proximal ring 122, and a distal ring 124. Each
of the proximal and distal rings 122, 124 can include radiopaque
material to aid in positioning of the implant during treatment.
Each ring 122, 124 can be welded, glued, or otherwise affixed to
the braid 110.
[0031] The braid 110 can be constructed from a shape memory alloy,
for example, Nitinol or other suitable memory shape material. The
braid 110 can have a pre-determined configuration, a deformed
configuration, and a deployed configuration. The pre-determined
configuration of the braid 110 is the configuration the braid 110
is trained to remember using, for example, via heat treatment. The
pre-determined configuration can be a cup-like or a bowl-like
shape. The deformed configuration of the braid 110 is the
configuration the of the braid 110 while the braid 110 is within
the guide catheter 310. In the deformed configuration, the braid
110 can be stretched into an elongated tube-like shape. The braid
110 can be moved from the pre-determined configuration to the
deformed configuration so that the braid 110 is sized to traverse
the catheter 310 to the aneurysm 10. The deployed configuration of
the braid 110 can be based on the pre-determined configuration or a
variant of the pre-determined configuration, for example, an
asymmetric cup-like configuration. The deployed configuration can
be a mutation of the pre-determined configuration, meaning as the
braid 110 moves to return to the pre-determined configuration while
within an aneurysm 10, it can contact and be constrained by a wall
14 of the aneurysm 10, thereby causing deviations in the
pre-determined configuration and yielding the deployed
configuration.
[0032] The delivery system 200, can have a delivery tube 210, a
pull wire 220, and an engagement wire 230. The delivery system 200
can be used to position and deploy the implant 100 within an
aneurysm 10. A guide catheter 310 can be used to provide a means to
deliver the implant 100 to the aneurysm 10 and/or to assist in the
positioning and deployment of the implant 100 within the aneurysm
10.
[0033] FIGS. 2A to 2C are illustrations of a distal end of an
exemplary system for assisting the reshaping the implant 100 from
the deformed configuration to the deployed configuration. As
illustrated, in FIG. 2A, the engagement wire 230 can have an
elongated member 236 with an engagement feature 238 attached to the
distal end of the elongated member 236. As illustrated, the pull
wire 220 and the elongated member 236 are configured to pass
through the lumen 128 of the distal ring 124 in a parallel
configuration. However, the engagement wire 230 can only pass so
far, as the engagement feature 238 cannot pass through the lumen
128 while the pull wire 220 also occupies the lumen 128. Note that
the pull wire 220 and engagement wire 230 can either be solid or
hollow and made of a material with properties sufficient to permit
the interference fit.
[0034] FIG. 2B is an illustration of the pull wire 220 retracted
from the lumen 128 of the distal ring 124. This position is the
beginning of releasing the braid 110, and a proximal force on the
engagement wire 230 will release the implant 100. However, even
though the interference fit has been released, it can still be
reengaged by moving the pull wire 220 back through the lumen 128.
This allows the physician to verify placement of the implant 100 in
the aneurysm 10 before losing all ability to further move or deform
the braid 110.
[0035] FIG. 2C is a cross-section view of FIG. 2A. The elongated
member 236 can have an elongated member diameter D5. The engagement
feature 238 can have an engagement feature diameter D1. The pull
wire 220 can have a pull wire diameter D2. A sum of the pull wire
diameter D2, and the engagement feature diameter D1 can be a total
diameter D12. The distal ring 124 having a ring inner diameter D4.
It will be noted that the total diameter D12 is greater than the
ring inner diameter D4 resulting in the interference fit, not
allowing the engagement feature 238 to retract through the lumen
128 of the distal ring 124 until the pull wire 220 is retracted
first. In this configuration, it is clear to see that the
engagement feature diameter D1, is less than the ring inner
diameter D4, allowing the engagement wire 230 to be retracted from
the lumen 128 of the distal ring 124. Different relationships bear
out from the above, in that D2+D5<D4 and D1+D2=D12>D4.
[0036] FIGS. 3A and 3B are illustrations of a delivery system 200
detaching from an implant 100, where FIG. 3A illustrates the
implant 100 detachably attached to the delivery system 200 and FIG.
3B illustrates the implant 100 and delivery system 200 shortly
after detachment of the implant 100.
[0037] Referring collectively to FIGS. 3A and 3B, the implant can
include a detachment feature 123 affixed thereto that is shaped and
otherwise configured to detachably engage the delivery system 200.
The implant 100 can further include a proximal ring 122. The
detachment feature 123 and/or the proximal ring 122 can be
constructed of radiopaque material to aid visualization of
placement of the implant 100. The proximal ring 122 can serve to
constrict the proximal end of the braid 110 and/or the proximal
ring 122 can provide a structure to aid in securing the braid 110
to the detachment feature 123.
[0038] As illustrated in FIG. 3A, when the implant 100 is attached
to the delivery system 200, the pull wire 220 and the engagement
wire 230 can be configured parallel to each other and configured to
pass through an aperture 218a of a loop wire 218, the lumen 126 of
the proximal ring 122 and the lumen 125 of the braid 110. The loop
wire 218 can be attached to a delivery tube 210 and can pass
through an opening 123a of a detachment feature 123. In this
configuration, the loop wire 218 detachably secures the detachment
feature 123 to the delivery tube 210. The detachment feature 123
can be attached to the proximal ring 122 of the implant 100 and
detachably attached to a notch 216 (See FIG. 4) in the delivery
tube 210. The notch 216 can be disposed on a distal end 214 of a
delivery tube 210.
[0039] The delivery tube 210 can be made of a biocompatible
material, such as stainless steel. The tube 210 can be suitably
sized for delivering and deploying the implant 100 to an aneurysm
10 as described herein.
[0040] As illustrated in FIG. 3B, the pull wire 220 and the
engagement wire 230 can be retracted proximally from the aperture
218a of the loop wire 218 and into the delivery tube 210. Upon the
pull wire 220 and the engagement wire 230 being retracted into the
delivery tube 210, the loop wire 218 falls out of the opening 123a
of the detachment feature 123 and no longer secures the detachment
feature 123 to the delivery tube 210, thereby enabling the
detachment feature 123 to detach from the delivery tube 210.
[0041] The loop wire 218 can be relatively small, having the
thickness of a hair in some examples, so it can be preferred for
the loop wire to be entirely shielded within the delivery tube 210
to prevent damage from accidental contact. The loop wire 218 can be
an elongated wire that is bent to form an opening. Alternatively,
the loop wire 218 can be a single elongated wire with an opening.
The loop wire 218 can be formed from any number of materials,
including nitinol and stainless steel.
[0042] FIG. 4 is a side cross-sectional view of FIG. 3A. As
illustrated, the detachment feature 123 can be seen detachable
attached to the notch 216 located at the distal end 214 of the
delivery tube 210. Further, the detachment feature 123 can be seen
attached to the proximal ring 122. The pull wire 220 and the
engagement wire 230 can be seen passing though the aperture 218a of
the loop wire 218. The loop wire 218 can be seen passing through an
opening 123a of the detachment feature 123 and securing the
detachment feature 123 to the notch 216.
[0043] FIGS. 5A to 5C are illustrations of an exemplary implant 100
in the pre-determined configuration outside the aneurysm 10 in the
deployed configuration within a cross-section of the aneurysm 10
respectively. The exemplary implant 100 can have a braid 110, a
proximal ring 122, a distal ring 124 and a detachment feature 123
such as illustrated and/or described herein or otherwise known by a
person of ordinary skill in the art. The proximal ring 122 can be
disposed on a proximal end 112 of the braid 110 and the distal ring
124 can be disposed on a distal end 114 of the braid 110. As
disclosed above, the detachment feature 123 can have an opening
123a.
[0044] As illustrated in FIG. 5A, in the predetermined shape, the
braid 110 can have a bowl, or cup shape. The distal and proximal
rings 124, 122 can be positioned along a central axis of the braid
110. The braid 110 can be folded such that the bowl defines two
nested bowls. The distal and proximal rings 124, 122 can be
respectively positioned at the trough of each nested bowl
shape.
[0045] As illustrated in FIG. 5B, the braid 110 of implant 100,
once in the deployed configuration, can have a fold 117, an inner
sack 116, an outer sack 118. The fold 117 can be a curvature of the
braid 110 that delineates the inner sack 116 from the outer sack
118. The outer sack 118 can contact the wall 14 of the aneurysm
10.
[0046] The braid 110 can be include a memory shape material and can
be heat-set or otherwise set to form the pre-determined shape. When
deformed, the braid 110 can be activated to move to the
pre-determined shape due to heat from contact blood or other bodily
fluid. Alternatively, the braid 110 need not include memory shape
material, and a delivery system 200 such as illustrated and
described herein can be sufficient to move the braid 110 from the
deformed shape as illustrated in FIG. 5C to the deployed
configuration illustrated in FIG. 5B.
[0047] As illustrated in FIG. 5C, in the deformed configuration,
the implant 100 can be collapsed and/or elongated to fit within a
guide catheter 310.
[0048] FIGS. 6A to 6D are an illustration of a deployment sequence
of an exemplary delivery system 200 and implant 100. As illustrated
in FIG. 6A, the implant 100 begins to expand from the deformed
configuration within the aneurysm 10 as it exits the catheter 310.
In FIG. 6A, the pull wire 220 and the engagement wire 230 are both
positioned to pass though the lumen 126 of the proximal ring 122,
the lumen 125 of the braid 110 and the lumen 128 of the distal ring
124. The pull wire 220 and the engagement wire 230 can be in the
parallel configuration discussed earlier in relation to FIG. 2A or
otherwise positioned as described herein. As illustrated in FIG.
6B, the engagement wire 230 and the pull wire 220 can be retracted
in a proximal direction such that the distal ring 124 is moved in a
proximal direction closer to the proximal ring 122. While the
engagement wire 230 and pull wire 220 are being retracted, the
braid 110 is reconfigured from the deformed configuration to the
deployed configuration such that the outer sack 118 contacts the
wall 14 of the aneurysm 10. The implant 100 can include memory
shape material, and the implant 100 can reshape based at least in
part on the pre-determined shape of the implant 100. Alternatively,
in some examples, the braid 110 need not include memory shape
material, and in such cases, the movement of the engagement wire
230 and pull wire 220 can be sufficient to reshape the braid 110 to
the deployed shape.
[0049] As illustrated in FIG. 6C, the pull wire 220 can be
retracted in a proximal direction into the delivery tube 210. A
slight adjustment of the engagement wire 230 in the distal
direction can be made to allow for the pull wire 220 to be
retracted. The pull wire 220 can be configured to pass though the
lumen 128 of the distal ring 124, the lumen 125 of the braid 110,
the lumen 126 of the proximal ring 122 and the aperture 218a of the
loop wire 218. Further details regarding retraction are discussed
earlier in FIGS. 2A to 2C.
[0050] As illustrated in FIG. 6D, the engagement wire 230 can be
retracted in a proximal direction into the delivery tube 210. The
engagement wire 230 is configured to pass though the lumen 128 of
the distal ring 124, the lumen 125 of the braid 110, the lumen 126
of the proximal ring 122 and the aperture 218a of the loop wire
218. Further details regarding retraction are discussed earlier in
FIGS. 2A to 2C.
[0051] FIGS. 7A and 7B are an illustration of a cross-section of an
alternative exemplary delivery system 200 for deploying an
exemplary implant 100 into the aneurysm 10.
[0052] As illustrated in FIG. 7A, a distal end 324 of a hollow push
rod 320, can engage the proximal ring 122 of the implant 100. The
lumen 326 of the hollow push rod 320 can be sized to permit the
engagement wire 230 and the pull wire 220 to pass though the hollow
push rod 320. The hollow push rod 320 can be pushed in a distal
direction causing the engaged implant 100 to also be pushed
distally towards, and exit out of, a distal end 314 of the guide
catheter 310. The implant 100 can be in the deformed configuration,
such as illustrated in FIG. 5C. A guide catheter inner diameter D7
can be sized to permit the hollow push rod 320 and the implant 100
to pass though the lumen 316 of the guide catheter 310. A push rod
inner diameter D6, is configured such that it is greater than or
equal to the total diameter D12.
[0053] As illustrated in FIG. 7B, the distal end 324 hollow push
rod 320 can remain engaged to the proximal ring 122 as the
engagement wire 230 and pull wire 220 are retracted in a proximal
direction into the hollow push rod 320. As a result of the
reaction, the implant 100 can be moved from the deformed
configuration, illustrated in FIG. 7A, to the deployed
configuration shown here. The proximal end of the braid 110 can be
retained within the guide catheter 310 until after the braid 110 is
fully deployed within the aneurysm. After the braid 110 is
deployed, the pull wire 220, then the engagement wire 230 can be
retracted. Once the pull wire 220 and engagement wire 230 are
disengaged from the implant 100, the catheter 310 can be retracted,
thereby completing implantation.
[0054] Illustrations in the above-described figures depict
generally hollow or delivery tubes 210 according to the present
invention. When used herein, the terms "tubular" and "tube" are to
be construed broadly and are not limited to a structure that is a
right cylinder or strictly circumferential in cross-section or of a
uniform cross-section throughout its length. For example, the
tubular structure or system is generally illustrated as a
substantially right cylindrical structure. However, the tubular
system may have a tapered or curved outer surface without departing
from the scope of the present invention.
[0055] FIG. 8 illustrates an example method 800 for constructing or
configuring an implant and a delivery system such as an exemplary
implant 100 and/or an exemplary delivery system 200 as presented
herein, variations thereof, or alternatives thereof as would be
appreciated and understood by a person of ordinary skill in the
art.
[0056] At block 802, an implant having a distal band can be
positioned within a guide catheter. The distal band and guide
catheter can be a distal band 124 and guide catheter 310 as
presented herein, a variation thereof, or an alternative thereof as
would otherwise be appreciated and understood by a person of
ordinary skill in the art. In some examples, a delivery tube can
also be positioned within the guide catheter, proximal to the
implant. The delivery tube can be a delivery tube 210 as presented
herein, a variation thereof, or alternative thereof as would be
appreciated and understood by a person of ordinary skill in the
art. The delivery tube, guide catheter, and implant can be
positioned as presented herein or as otherwise would be appreciated
and understood by a person of ordinary skill in the art.
Additionally, or alternatively, the delivery tube can be a hollow
push rod 320 as presented herein, a variation thereof, or an
alternative as would be appreciated and understood by a person of
ordinary skill in the art. In such an example, the hollow push rod
can be positioned within the guide catheter, proximal to the
implant as presented herein or otherwise positioned as would be
appreciated and understood by a person of ordinary skill in the
art.
[0057] At block 804 a pull wire and an engagement wire are extended
through the aperture of the loop wire and the lumen of the proximal
ring. The pull wire, engagement wire, loop wire, and proximal ring
can each respectively be a pull wire 220, engagement wire 230, loop
wire 218, and proximal ring 122 as presented herein, a variation
thereof, or an alternative thereof as would be appreciated and
understood by a person of ordinary skill in the art. In some
examples, the engagement wire 230 can be extended through the
aperture 218a of the loop wire 218 before the pull wire 220 can be
extended through the aperture 218a of the loop wire 218.
Alternatively, the engagement wire 230 can be extended through the
lumen 126 of the proximal ring 122 before the pull wire 220 can be
extended through the lumen 126 of the proximal ring 122. In some
examples, the engagement wire 230 need not be extended through the
aperture 218a of the loop wire 218. In some examples, the pull wire
220 need not be extended though the aperture 218a of the loop wire
218. In some examples, neither the pull wire 220 nor the engagement
wire 230 is extended through aperture 218a of the loop wire 218 and
the detachment feature 123 need not be present. The pull wire 220
and the engagement wire 230 can be extended through the lumen 125
of the braid 110. In some examples, the engagement wire 230 can be
extended though the lumen 125 of the braid 110 before the pull wire
220 can be extended through the lumen 125 of the braid 110. The
pull wire 220 and the engagement wire 230 are extended through the
lumen 128 of the distal band 124. In some examples, the engagement
wire 230 can be extended though the lumen 128 of the distal band
124 before the pull wire 220 can be extended through the lumen 128
of the distal band 124. The implant 100 with the pull wire 220 and
the engagement wire 230 therethrough can be positioned within a
delivery catheter 310 such that the engagement feature 238 can be
positioned in the distal direction in relation to the distal band
124.
[0058] At block 806, the implant 100 can pass though the neck 16 of
the aneurysm 10, to enter the aneurysm's sac 12 by pushing the
implant 100 using either a hollow push rod 320 or a delivery tube
210. In some examples, the distal end of the hollow push rod 320
can engage the proximal band 122 of the implant 100 permitting the
hollow push rod 320 to push the implant 100 into the sac 12 of the
aneurysm 10. In some examples, the detachment feature 123 can be
secured to the notch 216 of the delivery tube 210 via the loop wire
218, allowing the delivery tube 210 to push the implant 100 into
the sac 12 of the aneurysm 10.
[0059] At block 808, the implant 100 can be reshaped within the sac
12 by retracting the engagement wire 230 in a proximal direction
while the pull wire 220 remains extended though the lumen 128 of
the distal band 124. This causes the distal band 124 to move in a
proximal direction, thereby reshaping the braid 110.
[0060] At block 810, the pull wire 220 can be retracted through the
lumen 128 of the distal ring 124, the lumen 125 of the braid 110,
and the lumen 126 of the proximal band 122 in a proximal direction.
In some examples the pull wire 220 can be retracted through the
aperture 218a of the loop wire 218.
[0061] At block 812, the engagement wire 230 can be retracted
through the lumen 128 of the distal band 124, the lumen 125 of the
braid 110, and the lumen 126 of the proximal band 122 in a proximal
direction. In some examples the engagement wire 230 can be
retracted through the aperture 218a of the loop wire 218.
[0062] At block 814, the implant 100 can be disengaged from the
delivery system 200 via the retraction of the delivery tube 210,
resulting in loop wire 218 to fall out of the opening 123a of the
detachment feature 123, and thus allowing the detachment feature
123 to detach from the notch 216 of the delivery tube 210.
Alternatively, the hollow push rod 320 pushes the implant 100 out
of the guide catheter 310 and into the sac 12 without the use of
the detachment feature 123 or the loop wire 218.
[0063] FIG. 9 illustrates an example method 900 for deploying an
implant using a delivery system such as an exemplary implant 100
and/or an exemplary delivery system 200 as presented herein,
variations thereof, or alternatives thereof as would be appreciated
and understood by a person of ordinary skill in the art.
[0064] At block 902, a distal ring can be positioned along a
central axis approximate the distal end of a tubular braid. The
distal ring and tubular braid can each respectively be a distal
ring 124 and tubular braid 110 as presented herein, a variation
thereof, or an alternative thereof as would be appreciated and
understood by a person of ordinary skill in the art. The distal
ring 124 can be attached to the distal end 114 of the tubular braid
110.
[0065] At block 904, the delivery system can include an engagement
wire comprising an engagement feature and elongated member, and the
engagement feature can be positioned at the distal end of the
elongated member. The engagement wire can be an engagement wire 230
as presented herein, a variation thereof, or an alternative thereof
as would be appreciated and understood by a person of ordinary
skill in the art. The engagement feature 238 can extend radially
from a distal end 234 of the elongated member 236. The engagement
feature can be formed by grinding, welding, gluing, or other means
as would be appreciated and understood by a person of ordinary
skill in the art. For instance, polymer or metal sleeves can be
affixed to a portion of the core wire, the core wire can form the
elongated member of the engagement wire, and the sleeves can be
ground down to the desired shape to form the engagement feature.
Alternatively, the engagement feature can be formed by creating a
weld bead on the end of a core wire, the core wire forming the
elongated member of the engagement wire.
[0066] At block 906, a proximal ring can be positioned at the
proximal end of the braid. The proximal ring can be a proximal ring
122 as presented herein, a variation thereof, or an alternative
thereof as would be appreciated and understood by a person of
ordinary skill in the art. The proximal ring 122 can be attached to
the proximal end 112 of the tubular braid 110. In some examples, a
detachment feature such as a detachment feature 123 presented
herein, variation thereof, or alternative thereof can be attached
to the proximal ring 122.
[0067] At block 908, a pull wire 220 and the engagement wire 230
are extended through the aperture 218a of a loop wire 218 and the
lumen 126 of the proximal ring 122. The pull wire and loop wire can
each respectively be a pull wire 220 and loop wire 218 as presented
herein, a variation thereof, or an alternative thereof as would be
appreciated and understood by a person of ordinary skill in the
art. The loop wire 218 can be affixed to a delivery tube such as a
delivery tube 210 presented herein, variation thereof, or
alternative thereof as would be appreciated and understood by a
person of ordinary skill in the art. Extension of the loop wire 218
and/or pull wire 220 through the aperture 218a of the loop wire 218
can serve to releasably secure the implant 100 to the delivery tube
210. In an exemplary system, the engagement wire 230 can be
extended through the aperture 218a of the loop wire 218 before the
pull wire 220 can be extended through the aperture 218a of the loop
wire 218. In another exemplary system, the engagement wire 230 can
be extended through the lumen 126 of the proximal ring 122 before
the pull wire 220 can be extended through the lumen 126 of the
proximal ring 122. In yet another exemplary system, the engagement
wire 230 need not extend through the aperture 218a of the loop wire
218. In still another exemplary system, the pull wire 220 need not
extend though the aperture 218a of the loop wire 218. In still yet
another exemplary system, neither the pull wire 220 nor the
engagement wire 230 extend through aperture 218a of the loop wire
218 and the detachment feature 123 need not be present.
[0068] At block 910, the pull wire 220 and the engagement wire 230
are extended through the lumen 125 of the tubular braid 110. In an
exemplary system, the engagement wire 230 can be extended though
the lumen 125 of the tubular braid 110 before the pull wire 220 can
be extended through the lumen 125 of the tubular braid 110.
[0069] At block 912, the pull wire 220 and the engagement wire 230
are extended through the lumen 128 of the distal ring 124. In an
exemplary system, the engagement wire 230 can be extended though
the lumen 128 of the distal ring 124 before the pull wire 220 can
be extended through the lumen 128 of the distal ring 124.
[0070] At block 914, the implant 100 with the pull wire 220 and the
engagement wire 230 therethrough can be positioned within a
delivery catheter 310 such that the engagement feature 238 is
positioned in the distal direction in relation to the distal ring
124.
[0071] At block 916, the implant 100 can be disengaged from the
delivery system 200 via the retraction of the pull wire 220 and the
engagement wire 230 from the lumen 128 of the distal ring 124, the
lumen 125 of the tubular braid 110, and the lumen 126 of the
proximal ring 122. In an exemplary system, at least one of the pull
wire 220 or the engagement wire 230 can be retracted from the
aperture 218a of the loop wire 218.
[0072] The descriptions contained herein are examples of
embodiments of the invention and are not intended in any way to
limit the scope of the invention. As described herein, the
invention contemplates many variations and modifications of the
implant system, including alternative geometries of elements and
components described herein, alternative braid shapes, utilizing
one or more of several means for braiding, knitting, weaving, or
otherwise forming the braid, utilizing alternative materials for
each component or element (e.g. radiopaque materials, memory shape
materials, polymers, metals, etc.), utilizing additional components
to perform functions described herein or not described herein.
These modifications would be apparent to those having ordinary
skill in the art to which this invention relates and are intended
to be within the scope of the claims which follow.
* * * * *