U.S. patent application number 17/473230 was filed with the patent office on 2021-12-30 for adhesive cover occluding device for aneurysm treatment.
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 Daniel SOLAUN.
Application Number | 20210401441 17/473230 |
Document ID | / |
Family ID | 1000005836498 |
Filed Date | 2021-12-30 |
United States Patent
Application |
20210401441 |
Kind Code |
A1 |
SOLAUN; Daniel |
December 30, 2021 |
ADHESIVE COVER OCCLUDING DEVICE FOR ANEURYSM TREATMENT
Abstract
The device includes a net portion for occluding an aneurysm neck
and an adhesive to secure the net portion. The device can further
include a channel orifice opening in the net portion, and an agent
channel for delivering a rapid-curing agent through the orifice
into the aneurysm. Devices can be delivered through a catheter to
the aneurysm, the net can expand to occlude the aneurysm neck, and
the net can be adhered to the aneurysm neck. In devices including a
channel orifice and agent channel, the rapid-curing agent can be
injected into the aneurysm. During injection of the rapid-curing
agent, the net portion can create a barrier to inhibit the
rapid-curing agent from exiting the aneurysm. After injection of
the coagulation agent, portions of the treatment device, excluding
the net portion, can be extracted from the patient.
Inventors: |
SOLAUN; Daniel; (Miami,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DePuy Synthes Products, Inc. |
Raynham |
MA |
US |
|
|
Assignee: |
DePuy Synthes Products,
Inc.
Raynham
MA
|
Family ID: |
1000005836498 |
Appl. No.: |
17/473230 |
Filed: |
September 13, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
16269209 |
Feb 6, 2019 |
11134953 |
|
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17473230 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/12113 20130101;
A61B 17/12186 20130101; A61F 2250/0067 20130101; A61B 17/1214
20130101; A61B 2017/1205 20130101; A61B 17/1219 20130101; A61F
2002/823 20130101; A61B 17/12168 20130101 |
International
Class: |
A61B 17/12 20060101
A61B017/12 |
Claims
1. A treatment device for treating an aneurysm comprising: a net
portion expandable from a collapsed configuration to an occluding
configuration, the occluding configuration sized to extend across
and occlude at least a portion of a neck of the aneurysm to create
a barrier between a blood vessel and the aneurysm; and an adhesive
circumscribing at least a portion of a perimeter of the net portion
when the net portion is in the occluding configuration, the
adhesive being positioned to contact with tissue approximate the
aneurysm neck thereby securing the net portion in a position
approximate the aneurysm neck; and an adhesive barrier configured
to be removed to expose the adhesive agent.
2. The treatment device of claim 1, wherein the net portion in the
collapsed configuration is sized to traverse through a lumen of a
delivery catheter.
3. The treatment device of claim 1, wherein the adhesive barrier is
removed to expose the adhesive agent located on at least a portion
of the perimeter of the net portion subsequent to the net portion
reaching the occluding configuration.
4. The treatment device of claim 1, wherein the adhesive barrier is
removed to expose the adhesive agent located on at least a portion
of the perimeter of the net portion prior to the net portion
reaching the occluding configuration.
5. The treatment device of claim 1, wherein the adhesive barrier is
removed to expose the adhesive agent located on at least a portion
of the perimeter of the net portion upon delivery of the net
portion to the aneurysm.
6. The treatment device of claim 2, wherein the adhesive barrier is
removed to expose the adhesive agent located on at least a portion
of the perimeter of the net portion upon exiting the delivery
catheter.
7. The treatment device of claim 1 further comprising: a channel
orifice defining an opening in the net portion, wherein in the
occluding configuration the channel orifice is open to the
aneurysm; and an agent channel in communication with the channel
orifice delivering a rapid-curing agent to an aneurysm sac through
the channel orifice.
8. The treatment device of claim 7 further comprising: a trigger
mechanism for introducing the rapid-curing agent into the agent
channel; wherein the agent channel comprises a proximal end in
communication with the trigger mechanism to receive the
rapid-curing agent into the agent channel and a distal end in
communication with the channel orifice; and wherein the agent
channel delivers the rapid-curing agent from the proximal end to
the distal end and through the channel orifice into the sac of the
aneurysm.
9. A method for treating an aneurysm comprising: providing a
treatment device comprising a net portion, an adhesive
circumscribing at least a portion of a perimeter of the net
portion, and a removable adhesive barrier covering at least a
portion of the adhesive; delivering the treatment device to an
aneurysm treatment site; expanding the net portion to an occluding
configuration approximate a center of an aneurysm neck, wherein the
expanded net portion occludes at least a portion of the aneurysm
neck to create a barrier between a blood vessel and the aneurysm;
removing the adhesive barrier to expose a portion of the adhesive
to tissue approximate the aneurysm neck prior to, during, or after
the expansion step; and adhering the net portion approximate to the
aneurysm neck by the adhesive.
10. The method of claim 9, wherein the net portion in the collapsed
configuration is sized to traverse through a lumen of a delivery
catheter.
11. The method of claim 9, wherein the adhesive barrier is removed
to expose the adhesive agent located on at least a portion of the
perimeter of the net portion subsequent to the net portion reaching
the occluding configuration.
12. The method of claim 9, wherein the adhesive barrier is removed
to expose the adhesive agent located on at least a portion of the
perimeter of the net portion prior to the net portion reaching the
occluding configuration.
13. The method of claim 9, wherein the adhesive barrier is removed
to expose the adhesive agent located on at least a portion of the
perimeter of the net portion upon delivery of the net portion to
the aneurysm.
14. The method of claim 10, wherein the adhesive barrier is removed
to expose the adhesive agent located on at least a portion of the
perimeter of the net portion upon exiting the delivery
catheter.
15. The method of claim 10 further comprising: introducing a
rapid-curing agent through an agent channel to the aneurysm sac,
the agent channel in communication with a channel orifice defining
an opening in the net portion, wherein in the occluding
configuration the channel orifice is open to the aneurysm.
16. The method of claim 15, wherein the treatment device further
comprises: a trigger mechanism for introducing the rapid-curing
agent into the agent channel; wherein the agent channel comprises a
proximal end in communication with the trigger mechanism to receive
the rapid-curing agent into the agent channel and a distal end in
communication with the channel orifice; and wherein the agent
channel delivers the rapid-curing agent from the proximal end to
the distal end and through the channel orifice into the sac of the
aneurysm.
17. A method for treating an aneurysm comprising: providing a
treatment device comprising a net portion, an adhesive
circumscribing at least a portion of a perimeter of the net portion
when the net portion is in an occluding configuration, a removable
adhesive barrier covering at least a portion of the adhesive, a
channel orifice defining an opening in the net portion, and an
agent channel; joining the agent channel with the channel orifice;
delivering the treatment device to an aneurysm treatment site via a
delivery catheter; expanding the net portion to the occluding
configuration approximate a center of an aneurysm neck, wherein the
expanded net portion occludes at least a portion of the aneurysm
neck to create a barrier between a blood vessel and the aneurysm to
prevent a rapid-curing agent from entering the blood vessel;
adhering the net portion approximate to the aneurysm neck by
removing the adhesive barrier such that the adhesive contacts
tissue approximate the aneurysm neck prior to, during, or after the
expansion step; and delivering the rapid-curing agent through the
agent channel and the channel orifice into the aneurysm sac to
coagulate the blood present in the aneurysm.
18. The method of claim 17, wherein the adhesive barrier is removed
to expose the adhesive agent located on at least a portion of the
perimeter of the net portion subsequent to the net portion reaching
the occluding configuration.
19. The method of claim 17, wherein the adhesive barrier is removed
to expose the adhesive agent located on at least a portion of the
perimeter of the net portion prior to the net portion reaching the
occluding configuration.
20. The method of claim 17, wherein the adhesive barrier is removed
to expose the adhesive agent located on at least a portion of the
perimeter of the net portion upon exiting the delivery catheter.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation application of
U.S. patent application Ser. No. 16/269,209 filed Feb. 6, 2019, the
entire contents of which are hereby incorporated by reference.
FIELD OF INVENTION
[0002] The present invention generally relates to medical
instruments, and more particularly, to treatment devices for
aneurysm therapy.
BACKGROUND
[0003] Aneurysms can be complicated and difficult to treat. For
example, treatment access can be limited or unavailable when an
aneurysm is located proximate critical tissues. Such factors are of
particular concern with cranial aneurysms due to the brain tissue
surrounding cranial vessels and the corresponding limited treatment
access.
[0004] Prior solutions have included endovascular treatment access
whereby an internal volume of the aneurysm sac is removed or
excluded from arterial blood pressure and flow. In this respect,
because the interior walls of the aneurysm can continue being
subjected to flow of blood and related pressure, aneurysm rupture
remains possible.
[0005] Alternative to endovascular or other surgical approaches can
include occlusive devices. Such devices have typically incorporated
multiple embolic coils that are delivered to the vasculature using
microcatheter delivery systems. For example, when treating cranial
aneurysms, a delivery catheter with embolic coils is typically
first inserted into non-cranial vasculature through a femoral
artery in the hip or groin area. Thereafter, the catheter is guided
to a location of interest within the cranium. The sac of the
aneurysm can then be filled with the embolic material to create a
thrombotic mass that protects the arterial walls from blood flow
and related pressure. However, such occlusive devices do have
certain shortcomings, including mass effect, which can cause
compression on the brain and its nerves. Obtaining an embolic coil
packing density sufficient to either occlude the aneurysm neck or
fill the aneurysm sac is difficult and time consuming. Further,
aneurysm morphology (e.g. wide neck, bifurcation, etc.) can require
ancillary devices such a stents or balloons to support the coil
mass and obtain the desired packing density. The coils and
accompanying ancillary devices can remain in patients for their
entire lives, and can apply damaging stressing forces to the
aneurysm. Current embolic coil approaches can also involve the
delivery of various coils into a coil mass. With each coil
inserted, there is an increased risk for an adverse event.
Therefore, there is an advantage to creating a system that does not
require multiple products or coils to be inserted during one
procedure. Additionally, embolic coils do not always effectively
treat aneurysms as re-canalization of the aneurysm and/or coil
compaction can occur over time.
[0006] One particular type of occlusive approach endeavors to
deliver and treat the entrance or "neck" of the aneurysm as opposed
to the volume of the aneurysm by implanting a device in the parent
vessel of the aneurysm. In such "neck" approaches, by minimizing
blood flow across the neck, a cessation of flow into the aneurysm
can be achieved. In turn, a thrombotic mass can naturally form
without having to deliver embolic materials into the aneurysm sac,
as previously described. However, neck-occlusive approaches, such
as implanting a flow impeding device in the parent vessel, are not
without drawbacks. This type of approach can impede blood flow into
peripheral blood vessels while blocking the aneurysm neck in the
parent vessel. Impeding flow to the peripheral blood vessel can
unintentionally lead to severe damage if the openings of the
vessels are blocked.
[0007] Another type of occlusive approach is to use glues,
adhesives, or other similar products (e.g., NBCA (N-butyl
cyanoacrylate)) to obstruct blood flow to areas of the brain.
However, these products, when inserted into cranial vessels alone,
can move downstream and cause embolization in areas that are not
desirable. It is therefore desirable to have a device which easily,
accurately, and safely occludes a neck of an aneurysm or other
arterio-venous malformation in a parent vessel and can maintain the
placement of any glues or adhesives used without requiring the
insertion of multiple products or blocking flow into peripheral
vessels communicating with the parent vessel while minimizing
applied forces to the aneurysm.
[0008] It is an aim of this invention to resolve these and other
issues of the art.
SUMMARY
[0009] Disclosed herein are various exemplary devices for treating
an aneurysm with an adhesive cover treatment device. The devices
can generally include a net portion for occluding an aneurysm neck
and an adhesive to secure the net portion. The devices can further
include a channel orifice opening in the net portion, and an agent
channel for delivering a rapid-curing agent through the orifice
into the aneurysm. Devices can be delivered through a catheter to
the aneurysm, the net can expand to occlude the aneurysm neck, the
net can be adhered to the aneurysm neck. In devices including a
channel orifice and agent channel, the rapid-curing agent can be
injected into the aneurysm. During injection of the rapid-curing
agent, the net portion can create a barrier to inhibit the
rapid-curing agent from exiting the aneurysm. After injection of
the coagulation agent, portions of the treatment device, excluding
the net portion, can be extracted from the patient.
[0010] An example treatment device for occluding an aneurysm can
include a net portion that is expandable from a collapsed
configuration to an occluding configuration and an adhesive for
securing the net portion. The net portion in the occluding
configuration can occlude an aneurysm neck to create a barrier
between the aneurysm and a blood vessel. The adhesive can secure
the net portion in its position in the occluding configuration near
the aneurysm neck to prevent the net portion from dislodging and
disrupting the barrier between the aneurysm and the blood vessel.
When the barrier formed by the net portion is adhered in place, the
aneurysm can self-embolize. The example device can be delivered to
the aneurysm using a microcatheter.
[0011] The adhesive can be activated prior to or subsequent to the
net portion reaching the occluding configuration, such as prior to
delivery of the net portion to the aneurysm, upon delivery of the
net portion to the aneurysm, when the net portion reaches the
occluding configuration, or after the net portion reaches the
occluding configuration.
[0012] An example device for occluding an aneurysm can further
include a hypotube spanning at least a portion of the perimeter of
the net portion that contains the adhesive in an uncured state. The
hypotube can contain at least one hypotube orifice that exposes at
least some of the adhesive in the uncured state to an environment
outside the net portion. A curing channel can deliver a curing
agent to the net portion to activate the adhesive from the uncured
state. The adhesive can then adhere the net portion in the
occluding configuration in its position occluding the aneurysm
neck.
[0013] An example device can further include a delivery channel for
delivering the adhesive to the net portion. The delivery channel
can have a distal end connected to the net portion. The adhesive
can be delivered to the net portion prior to or subsequent to the
net portion reaching the occluding configuration, such as prior to
delivery of the net portion to the aneurysm, upon delivery of the
net portion to the aneurysm, when the net portion reaches the
occluding configuration, or after the net portion reaches the
occluding configuration.
[0014] An example device for occluding an aneurysm can further
include a channel orifice and an agent channel. The channel orifice
can define an opening in the net portion through which the
rapid-curing agent can be injected. The channel orifice can open
towards the aneurysm when the net portion is in the occluding
configuration. The agent channel can be in communication with the
channel orifice and can deliver the rapid-curing agent through the
channel orifice into the aneurysm sac.
[0015] The agent channel can have a proximal end and a distal end.
The distal end of the agent channel can communicate with the
channel orifice to transfer the rapid-curing agent into the
aneurysm sac. The proximal end of the agent channel can receive the
rapid-curing agent. The channel orifice can also be an opening in
the distal end of the agent channel, whereby a single opening
functions as both the channel orifice and the distal end of the
agent channel.
[0016] The example device can further include a trigger mechanism
in communication with the proximal end of the agent channel. The
trigger mechanism can communicate with the proximal end of the
agent channel to receive the rapid-curing agent or introduce the
rapid-curing agent into the agent channel. The trigger mechanism
can facilitate delivery of the rapid-curing agent from the proximal
end to the distal end of the agent channel, and then through the
channel orifice into the aneurysm sac.
[0017] An example method for treating an aneurysm can include
providing an exemplary treatment device which can include a net
portion and an adhesive; delivering the exemplary treatment device
to an aneurysm treatment site; expanding the net portion to an
occluding configuration at an aneurysm neck to occlude at least a
portion of the aneurysm neck to create a barrier between a blood
vessel and the aneurysm; and adhering the net portion approximate
to the aneurysm neck.
[0018] The method can further include inserting the adhesive in an
uncured state into a hypotube spanning at least a portion of the
perimeter of the net portion, where the hypotube contains at least
one hypotube orifice exposing at least some of adhesive the
environment outside the net portion; and delivering a curing agent
to the net portion via a curing channel to activate the
adhesive.
[0019] Another example method for treating an aneurysm can include
providing an exemplary treatment device which can include a net
portion, an adhesive, a channel orifice defining an opening in the
net portion, and an agent channel; joining the agent channel to the
channel orifice; delivering the exemplary treatment device to an
aneurysm treatment site; expanding the net portion to an occluding
configuration at an aneurysm neck to occlude at least a portion of
the aneurysm neck to create a barrier between a blood vessel and
the aneurysm to prevent a rapid-curing agent from entering the
blood vessel; adhering the net portion approximate to the aneurysm
neck; and delivering the rapid-curing agent through the agent
channel, through the channel orifice, and into the aneurysm sac to
coagulate the blood present in the aneurysm.
[0020] The method can further include providing a trigger
mechanism; triggering the delivery of the agent by activating the
trigger mechanism at a proximal end of the agent channel; and
delivering the agent from the proximal end of the agent channel to
a distal end of the agent channel.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The above and further aspects of this invention are further
discussed with reference to the
[0022] 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.
[0023] FIGS. 1a to 1c are illustrations of a treatment sequence of
an exemplary treatment device to occlude an aneurysm according to
aspects of the present invention;
[0024] FIGS. 2a to 2b are illustrations of a treatment sequence of
an exemplary treatment device to occlude an aneurysm according to
aspects of the present invention;
[0025] FIGS. 3a to 3d are illustrations of a treatment sequence of
an exemplary treatment device to occlude an aneurysm and deliver a
rapid-curing agent to an aneurysm according to aspects of the
present invention;
[0026] FIGS. 4a to 4d are illustrations of a treatment sequence of
an exemplary treatment device to occlude an aneurysm, and deliver
an adhesive to a net portion and a rapid-curing agent to an
aneurysm according to aspects of the present invention;
[0027] FIGS. 5a to 5g are illustrations of a treatment sequence of
an exemplary treatment device to occlude an aneurysm, and deliver a
curing agent to a net portion and a rapid-curing agent to an
aneurysm according to aspects of the present invention;
[0028] FIGS. 6a to 6d are illustrations of a treatment sequence of
an exemplary treatment device in connection with a trigger
mechanism to occlude an aneurysm and deliver a rapid-curing agent
to an aneurysm according to aspects of the present invention;
[0029] FIG. 7 is a flow diagram outlining example method steps that
can be carried out during delivery and use of a treatment device
according to aspects of the present invention; and
[0030] FIG. 8 is a flow diagram outlining example method steps that
can be carried out during delivery and use of a treatment device
according to aspects of the present invention.
DETAILED DESCRIPTION
[0031] The descriptions contained herein are examples of the
invention and are not intended in any way to limit the scope of the
invention. In general, example devices described herein describe a
treatment device that can be placed and adhered over the neck of an
aneurysm to create a barrier between the vessel and the aneurysm.
At least one rapid-curing agent can then be delivered into the
aneurysm sac. The rapid-curing agent can coagulate the blood in the
aneurysm instantly.
[0032] The example devices can include a net portion that can
expand from a collapsed configuration to an occluding configuration
in which the net portion in the occluding configuration is shaped
to occlude an aneurysm neck. The net portion can be adhered in
position to occlude the aneurysm neck. In the occluding
configuration, the net portion can generally have a channel orifice
working in connection with an agent channel that delivers a
rapid-curing agent through the channel orifice and into the
aneurysm sac.
[0033] It must be noted that, as used in the specification and the
appended claims, the singular forms "a," "an" and "the" include
plural referents unless the context clearly dictates otherwise. By
"comprising" or "containing" or "including" it is meant that at
least the named compound, element, particle, or method step is
present in the composition or article or method, but does not
exclude the presence of other compounds, materials, particles,
method steps, even if the other such compounds, material,
particles, method steps have the same function as what is
named.
[0034] In describing examples, terminology will be resorted to for
the sake of clarity. It is intended that each term contemplates its
broadest meaning as understood by those skilled in the art and
includes all technical equivalents that operate in a similar manner
to accomplish a similar purpose. It is also to be understood that
the mention of one or more steps of a method does not preclude the
presence of additional method steps or intervening method steps
between those steps expressly identified. Steps of a method can be
performed in a different order than those described herein without
departing from the scope of the disclosed technology. Similarly, it
is also to be understood that the mention of one or more components
in a device or system does not preclude the presence of additional
components or intervening components between those components
expressly identified.
[0035] FIGS. 1a through 1c are illustrations of stages or steps
that can occur during a treatment sequence of an exemplary
treatment device 100 delivered to an aneurysm 10. FIG. 1a is an
illustration of an example treatment device 100 wherein a net
portion 102 is shown in a collapsed delivery configuration inside a
delivery catheter 400. The net portion 102 can have an adhesive
agent 108 located on at least a portion of the outer perimeter of
the net portion 102, and an adhesive barrier 110 covering the
adhesive agent 108. The net portion 102 can be sized to fit within
the lumen of a delivery catheter 400 when the net portion 102 is in
the collapsed configuration. When the net portion 102 is in the
collapsed configuration, the net portion 102 can have sufficient
flexibility to be delivered through the delivery catheter 400,
navigating torturous anatomical geometries, to be delivered to an
aneurysm 10. The net portion 102 in the collapsed configuration can
have a substantially tubular shape.
[0036] Moving on to FIG. 1b, the treatment device 100 can be
delivered to an aneurysm 10 by sliding the device 100 distally when
the net portion 102 is in a collapsed configuration through a
delivery catheter 400. The treatment device 100 can be delivered to
a treatment site through a blood vessel 106. FIG. 1b illustrates
the treatment device 100 inside the delivery catheter 400 located
near an aneurysm neck 12. FIG. 1b further shows the net portion 102
pushed partially out of the delivery catheter 400 for deployment
inside the aneurysm sac 16. The net portion 102 can expand as it
exits the delivery catheter 400. The net portion 102 can include a
memory shape material such as Nitinol, a Nitinol alloy, a polymer
memory shape material, or other memory shape material having
properties for reshaping as described herein. The net portion 102
can be in a deformed shape in the collapsed configuration and
reshape based on a predetermined shape after exiting the delivery
catheter 400. As shown here, upon the net portion 102 exiting the
delivery catheter 400, the adhesive barrier 110 can be removed to
expose the adhesive agent 108 located on at least a portion of the
perimeter of the net portion. Alternatively, the adhesive barrier
110 can be removed at other times prior to or subsequent to the net
portion 102 reaching the occluding configuration, such as prior to
delivery of the net portion 102 to the aneurysm 10, upon delivery
of the net portion 102 to the aneurysm 10, when the net portion 102
reaches the occluding configuration, or after the net portion 102
reaches the occluding configuration. The adhesive agent 108 can
include medical grade silicone-based adhesives as well as
light-curable adhesives. The adhesive agent 108 can include
adhesives such as N-butyl cyanoacrylate (NBCA), Poly(methyl
methacrylate) (PMMA996), N-Methyl-2-Pyrrolidone (NMP), Carbonic
anhydrase-related protein 10 (CA10), EA/MMA, and DME.
[0037] FIG. 1c illustrates the example treatment device 100 wherein
the net portion 102 is in an occluding configuration in the
aneurysm 10. The net portion 102 in the occluding configuration can
be sized to occlude at least a portion of an aneurysm neck 12. The
net portion 102 in the occluding configuration can completely
occlude the aneurysm neck 12 as depicted in FIG. 1c. The net
portion 102 in the occluding configuration can occlude the neck 12
to create a barrier between a blood vessel 106 and the aneurysm 10.
The net portion 102 can occlude the aneurysm 10 from inside the
aneurysm sac 16. As illustrated in FIG. 1c, the exposed adhesive
agent 108 can be in contact with the aneurysm wall 14 when the net
portion 102 is in the occluding configuration. In occluding
configuration, the net portion 102 can be capable of deflecting a
blood flow from the aneurysm 10, diverting a blood flow from the
aneurysm 10, slowing a blood flow into the aneurysm 10, or any
combination thereof.
[0038] In the occluding configuration, the net portion 102 can
extend to the aneurysm wall 14, and the adhesive agent 108 can hold
the net portion 102 in its position relative to the aneurysm wall
14 and aneurysm neck 12 such that the treatment device 100 doesn't
become dislodged and therefore ineffective at inhibiting blood flow
into the aneurysm 10. The net portion 102 can also provide a force
against the aneurysm wall 14 to help maintain the occluding
configuration of the net portion 102 and assist the adhesive agent
108 in adhering to the aneurysm wall 14. For example, the net
portion 102 can be made of a memory shape material having a first,
predetermined shape and a second, collapsed shape in the collapsed
configuration. When the net portion 102 is in an occluding
configuration within the aneurysm 10, the net portion 102 can move
to a third, deployed shape that is based at least in part on the
first, predetermined shape and the anatomical geometry of the
aneurysm 10. In the example, the first, predetermined shape can be
sized larger than the wall 14 within the aneurysm sac 16; the net
portion 102 can move to extend to the wall 14; and the net portion
102 can provide a force against the wall 14 as the properties of
the memory shape material cause the net portion 102 to attempt to
open to the predetermined shape. This force can help the adhesive
agent 108 adhere to the wall to maintain the position of the net
portion 102. The net portion 102 in the occluding configuration can
take the shape of the aneurysm neck 12 and/or interior walls 14 of
the aneurysm near the aneurysm neck 12.
[0039] FIG. 2a illustrates the deployment of the net portion 102 in
the same manner described in FIG. 1b. FIG. 2a, however, shows the
net portion 102 pushed partially out of the delivery catheter 400
for deployment outside the aneurysm sac 16 across the aneurysm neck
12. FIG. 2b illustrates the example treatment device 100 wherein
the net portion 102 is in an occluding configuration outside of the
aneurysm 10. In this example, the adhesive agent 108 can adhere the
net portion 102 to the walls of the blood vessel 106 and over the
aneurysm neck 12 to deflect a blood flow from the aneurysm 10,
divert a blood flow from the aneurysm 10, slow a blood flow into
the aneurysm 10, or any combination thereof. The adhesive agent 108
can hold the net portion 102 in its position over the aneurysm neck
12 such that the treatment device 100 doesn't become dislodged and
therefore ineffective at inhibiting blood flow into the aneurysm 10
and becoming a potential blockage elsewhere in the vascular.
[0040] FIGS. 3a through 3c are illustrations of stages or steps
that can occur during a treatment sequence of an exemplary
treatment device 100 to occlude an aneurysm and deliver a
rapid-curing agent 114 to an aneurysm 10. FIG. 3a is an
illustration of an example treatment device 100 wherein the net
portion 102 with an adhesive agent 108 covered by an adhesive
barrier 110 is shown in a collapsed delivery configuration inside a
delivery catheter 400, similar to FIG. 1a. The net portion 102 can
contain a channel orifice 104 positioned on a proximal end of the
collapsed net portion 102. The channel orifice 104 can work in
connection with an agent channel 112. The channel orifice 104 can
be connected to the distal end 112a of the agent channel 112. The
treatment device 100 can be sized to fit within the lumen of a
delivery catheter 400 when the net portion 102 is in the collapsed
configuration. The agent channel 112 can have sufficient length to
be accessible outside of the patient when the net portion 102
reaches a treatment site. The net portion 102 is shown in a
collapsed delivery configuration inside a delivery catheter
400.
[0041] FIG. 3b illustrates the treatment device 100 inside the
delivery catheter 400 with the net portion 102 exiting the delivery
catheter 400 for deployment outside a sac 16 of an aneurysm 10,
similar to the manner described in FIG. 1b. Alternatively, the net
portion 102 can deploy inside the sac 16 of the aneurysm 10. As the
device 100 exits the delivery catheter 400, the adhesive agent 108
is exposed in the manner described in FIG. 1b.
[0042] FIG. 3c illustrates the treatment device 100 wherein the net
portion 102 is in the occluding configuration outside the aneurysm
sac 16 similar to FIG. 2b. As illustrated, the channel orifice 104
can be located in the net portion 102 such that the channel orifice
104 opens up to the aneurysm 10. The channel orifice 104 can be
centrally located in the net portion 102. The channel orifice 104
in the net portion 102 can work in connection with an agent channel
112. The agent channel 112 can allow for the transfer of one or
more rapid-curing agents 114 through the channel 112 to the channel
orifice 104. The rapid-curing agent 114 can include agents such as
collagen, chitosan, kaolin, zeolite, organic or biocompatible
solvents, or other agents having properties for rapid-curing as
described herein. The agent channel 112 can have a distal end 112a
and a proximal end 112b (see FIG. 6). The distal end 112a of the
agent channel 112 can connect to the channel orifice 104. The
proximal end 112b can receive the rapid-curing agent 114 into the
agent channel 112 and deliver the rapid-curing agent 114 from the
proximal end to the distal end 112a connected to the channel
orifice 104. The proximal end 112b can be accessible outside of the
patient for injection of the rapid-curing agent 114 into the
patient. Rapid-curing agent 114 passing through the lumen of the
agent channel 112 to the distal end 112a can subsequently pass
through the channel orifice 104 and into the aneurysm sac 16 upon
reaching the distal end 112a of the agent channel 112. The distal
end 112a of the agent channel 112 can also be the channel orifice
104 of the net portion 102. The rapid-curing agent 114 can
coagulate the blood inside the aneurysm 10. The rapid-curing agent
114 can coagulate the blood inside the aneurysm 10 virtually
instantaneously upon contacting the blood inside the aneurysm 10
according to the coagulation properties of the rapid-curing agent
114.
[0043] As shown in FIG. 3d, once the rapid-curing agent 114 has
been pumped into the aneurysm sac 16, the components of the
treatment device 100 (not shown) aside from the net portion 102 can
be removed from the aneurysm 10. The components of the treatment
device 100 aside from the net portion 102 can be removed once the
rapid-curing agent 114 has coagulated the blood in the aneurysm 10.
The components of the treatment device 100 aside from the net
portion 102 can be sized to traverse through a lumen of a retrieval
catheter (not shown).
[0044] FIGS. 4a to 4d are illustrations of stages or steps that can
occur during a treatment sequence of an exemplary treatment device
100 to occlude an aneurysm 10, deliver an adhesive 108 to the net
portion 102, and deliver a rapid-curing agent 114 to an aneurysm
10. FIG. 4a is an illustration of an example treatment device 100
wherein the net portion 102 is shown in a collapsed delivery
configuration inside a delivery catheter 400. The device 100 can
have a channel orifice 104 and agent channel 112 as described in
FIG. 3a. The device 100 can also have a delivery channel 118 that
can work in communication with the net portion 102. The delivery
channel 118 can have a distal end 118a in communication with the
net portion 102. The delivery channel 108 can deliver adhesive 108
the net portion 102 to adhere the net portion 102 approximate the
neck 12. The treatment device 100 can be sized to fit within the
lumen of a delivery catheter 400 when the net portion 102 is in the
collapsed configuration.
[0045] FIG. 4b illustrates the deployment of the net portion 102
inside the sac 16 of an aneurysm 10. As illustrated in FIG. 4b, the
treatment device 100 can be delivered to an aneurysm 10 by sliding
the device 100 distally when the net portion 102 is in a collapsed
configuration through a delivery catheter 400. The treatment device
100 can be delivered to a treatment site through a blood vessel
106. FIG. 4b illustrates the treatment device 100 inside the
delivery catheter 400 located near an aneurysm neck 12. FIG. 4b
further shows the net portion 102 pushed partially out of the
delivery catheter 400 for deployment inside the aneurysm sac 16.
The net portion 102 can expand as it exits the delivery catheter
400. Alternatively, the net portion 102 can deploy outside the sac
16 of the aneurysm 10.
[0046] FIG. 4c illustrates the treatment device 100 wherein the net
portion 102 is in the occluding configuration inside the aneurysm
sac 16. As shown in FIG. 4c, after the net portion 102 reaches the
occluding configuration, the adhesive agent 108 can be delivered to
the net portion 102 through the delivery channel 118 to adhere the
net portion 102 over the aneurysm neck 12 inside the aneurysm sac
16. Alternatively, delivery channel 118 can deliver adhesive 108 to
the net portion 102 to adhere the net portion 102 in the occluding
configuration over the aneurysm neck 12 outside the aneurysm sac
16. The adhesive 108 can also be delivered prior to or subsequent
to the net portion 102 reaching the occluding configuration, such
as prior to delivery of the net portion 102 to the aneurysm 10,
upon delivery of the net portion 102 to the aneurysm 10, or when
the net portion 102 reaches the occluding configuration. After the
net portion 102 is adhered over the neck 12, the rapid-curing agent
114 can be delivered to the aneurysm sac 16 in the manner described
in FIG. 3c.
[0047] As in FIG. 3d, FIG. 4d illustrates the aneurysm 10 once the
rapid-curing agent 114 has been pumped into the aneurysm sac 16,
after which the components of the treatment device 100 (not shown)
aside from the net portion 102 can be removed from the aneurysm
10.
[0048] FIGS. 5a to 5f are illustrations of stages or steps that can
occur during a treatment sequence of an exemplary treatment device
100 to occlude an aneurysm 10, deliver a curing agent 124 to the
net portion 102, and deliver a rapid-curing agent 114 to an
aneurysm 10. FIG. 5a is an illustration of an example treatment
device 100 wherein the net portion 102 is shown in a collapsed
delivery configuration inside a delivery catheter 400. The device
100 can have a channel orifice 104 and agent channel 112 as
described in FIG. 3a. The device 100 can also have a hypotube 120
spanning at least a portion of the perimeter of the net portion
102. The hypotube 120 can span the entire perimeter of the net
portion 102. The hypotube 120 can contain an adhesive 108 in an
uncured state. The hypotube 120 can contain one or more hypotube
orifices 122 (see FIG. 5d) that expose the uncured adhesive 108 to
the environment outside the hypotube 120.
[0049] The device 100 can further have a curing channel 126 that
can work in communication with the net portion 102. The curing
channel 126 can have a distal end 126a in connection with net
portion 102. The curing channel 126 can deliver a curing agent (as
discussed above) to the net portion 102 of the device 100. The
curing agent 126 can activate the uncured adhesive 108 in the net
portion 102. The treatment device 100 in its entirety can be sized
to fit within the lumen of a delivery catheter 400 when the net
portion 102 is in the collapsed configuration.
[0050] FIG. 5b illustrates the deployment of the net portion 102
inside the sac 16 of an aneurysm 10 similar to FIG. 4b. FIG. 5c
illustrates the treatment device 100 wherein the net portion 102 is
in the occluding configuration inside the aneurysm sac 16 in the
manner shown in FIG. 4c. As shown here, after the net portion 102
reaches the occluding configuration, the curing agent 124 can be
delivered to the net portion 102 through the curing channel 126 to
activate the adhesive agent 108 and adhere the net portion 102 over
the aneurysm neck 12 inside the aneurysm sac 16. Alternatively, the
curing agent 124 can be delivered to the net portion 102 through
the curing channel 126 to activate the adhesive agent 108 and
adhere the net portion 102 over the aneurysm neck 12 outside the
aneurysm sac 16. The curing agent 124 can be delivered prior to or
subsequent to the net portion 102 reaching the occluding
configuration, such as prior to delivery of the net portion 102 to
the aneurysm 10, upon delivery of the net portion 102 to the
aneurysm 10, or when the net portion 102 reaches the occluding
configuration.
[0051] FIG. 5d shows a blown-up and cross-sectional view of the
hypotube 120. The hypotube 120 can contain at least one hypotube
orifice 122 as well as the adhesive 108 in an uncured state. The
hypotube orifices 122 can expose the uncured adhesive 108 to the
environment outside the hypotube 120. FIG. 5e is a cross section of
net portion 102 loaded with adhesive 108. For example, in FIGS. 5d
and 5e, the uncured adhesive 108 can be delivered by first being
mechanically held within the net portion 102. The net portion 102
can contain a lumen along the circumference (a hypotube 122) with
orifices that allow the uncured adhesive to be exposed. The
viscosity of the adhesive 108 can be characterized such that it
could be injected into a lumen of the net portion 102 but viscous
enough that it will not relocate or disperse during delivery. Upon
placing the net portion 102 and later delivering a curing agent,
the adhesive within the net will be activated. The net would have
orifices that expose some of the adhesive to the aneurysm, allowing
it to adhere the edges of the net to the aneurysm wall. In this
case, the net would act as the device blocking flow into the
aneurysm
[0052] FIG. 5f illustrates the treatment device 100 wherein the net
portion 102 is in the occluding configuration inside the aneurysm
sac 16 in the manner shown in FIG. 4c. When the curing agent 124 is
delivered to the net portion 102, the adhesive 108 can cure and
adhere the net portion 102 in the occluding configuration over the
aneurysm neck 12 to occlude the aneurysm 10. Once the net portion
102 has been adhered in position, the rapid curing agent 114 can be
delivered to the aneurysm 10 as illustrated in FIG. 3c
[0053] Similar to FIG. 3d, FIG. 5g illustrates the aneurysm 10 once
the rapid-curing agent 114 has been pumped into the aneurysm sac
16, after which the components of the treatment device 100 aside
from the net portion 102 are removed from the aneurysm 10.
[0054] FIGS. 6a to 6e are illustrations of stages or steps that can
occur during another example implementation sequence of an
exemplary treatment device 100 to occlude an aneurysm 10 and
deliver a rapid-curing agent 114 to an aneurysm 10.
[0055] FIG. 6a is an illustration of an example treatment device
100 including a net portion 102, a channel orifice 104, an agent
channel 112, and a trigger mechanism 116. The net portion 102 is
shown in a collapsed delivery configuration inside a delivery
catheter 400. The net portion 102 can contain the channel orifice
104 that can be in communication with an agent channel 112. The
agent channel 112 can have a proximal end 112b in communication
with the trigger mechanism 116. The proximal end 112b of the agent
channel 112 can receive the rapid-curing agent 114 into the agent
channel 112 for delivery. The trigger mechanism 116 can facilitate
the delivery of the rapid-curing agent 114 to an aneurysm sac 16.
The components of the treatment device 100 excluding the trigger
mechanism 116 can be sized to fit within the lumen of a delivery
catheter 400 when the net portion 102 is in the collapsed
configuration.
[0056] FIG. 6b illustrates the treatment device 100 inside the
delivery catheter 400 with the net portion 102 exiting the delivery
catheter 400 for deployment outside the aneurysm sac 16 in a manner
similar to FIG. 4b. As illustrated in FIGS. 6b to 6d, the treatment
site can include an aneurysm 10 positioned adjacent bifurcated
blood vessel branches and the treatment device 100 can be delivered
to the aneurysm 10 through a stem branch 106 feeding the bifurcated
blood vessel branches.
[0057] FIG. 6c illustrates the treatment device 100 wherein the net
portion 102 is in an occluding configuration in the aneurysm 10.
Upon the net portion 102 reaching the occluding configuration, the
trigger mechanism 116 can facilitate the delivery of the
rapid-curing agent 114 through the agent channel 112 to the
aneurysm sac 16.
[0058] As in FIG. 3d, FIG. 6d illustrates the aneurysm 10 once the
rapid-curing agent 114 has been pumped into the aneurysm sac 16,
after which the components of the treatment device 100 aside from
the net portion 102 can be removed from the aneurysm 10.
[0059] FIG. 7 is a flow diagram outlining example method steps that
can be carried out during the administration of a treatment device
100. The method steps can be implemented by any of the example
means described herein or by any means that would be known to one
of ordinary skill in the art.
[0060] Referring to a method 700 outlined in FIG. 7, in step 710 a
treatment device comprising a net portion and an adhesive can be
provided for administration to a patient. In step 720, the
treatment device can be delivered to the aneurysm treatment site.
In step 730, the net portion can be expanded to an occluding
configuration approximate a center of an aneurysm neck, wherein the
expanded net portion occludes at least a portion of the aneurysm
neck to create a barrier between a blood vessel and the aneurysm.
In step 740, the net portion can be adhered approximate to the
aneurysm neck.
[0061] Method 700 can further comprise the steps of inserting the
adhesive in an uncured state into a hypotube spanning at least a
portion of the perimeter of the net portion, wherein the hypotube
comprises at least one hypotube orifice exposing a portion of the
adhesive in the uncured state to the environment outside the net
portion, and delivering a curing agent to the net portion via a
curing channel to activate the adhesive.
[0062] FIG. 8 is a flow diagram outlining example method steps that
can be carried out during the administration of a treatment device
100. The method steps can be implemented by any of the example
means described herein or by any means that would be known to one
of ordinary skill in the art.
[0063] Referring to a method 800 outlined in FIG. 8, in step 810
the treatment device comprising a net portion, an adhesive, a
channel orifice defining an opening in the net portion, and an
agent channel can be provided for administration to a patient. In
step 820, the agent channel can be joined to communicate with the
channel orifice. In step 830, the treatment device can be delivered
to an aneurysm treatment site. In step 840, the net portion can be
expanded to the occluding configuration approximate a center of an
aneurysm neck. When the net portion is expanded to the occluding
configuration in step 840, the net portion can occlude at least a
portion of an aneurysm neck. Step 840 can also create a barrier
between a blood vessel 106 and the aneurysm to prevent the
rapid-curing agent from entering the blood vessel. In step 850, net
portion can be adhered approximate to the aneurysm neck. In step
860, the rapid-curing agent can be delivered through the agent
channel and the channel orifice into the aneurysm sac to coagulate
the blood present in the aneurysm.
[0064] Method 800 can further comprise the steps of providing a
trigger mechanism and triggering the delivery of the agent by
activating the trigger mechanism at a proximal end of the agent
channel to deliver the agent from the proximal end of the agent
channel to a distal end of the agent channel.
[0065] It should be apparent to those skilled in the art that the
present teachings cover devices with any possible combination of a
net portion, adhesive, channel orifice, agent channel, hypotube,
delivery channel, curing channel, and/or trigger mechanism. The
descriptions contained herein are examples 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 device for occluding an aneurysm, including
alternative geometries of elements and components described herein,
utilizing any number of known means for braiding, knitting,
weaving, or otherwise forming the net portion as is known in the
art, utilizing any of numerous materials for each component or
element (e.g. radiopaque materials, memory shape materials, etc.),
utilizing additional components including components to deliver a
treatment device to an aneurysm or eject an treatment device from a
delivery catheter, or utilizing additional components to perform
functions not described herein, for example. 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.
* * * * *