U.S. patent application number 10/400185 was filed with the patent office on 2004-05-20 for containers and methods for delivering vaso-occluding filaments and particles.
This patent application is currently assigned to CONCENTRIC MEDICAL, INC.. Invention is credited to Dieck, Martin S., French, Ron, Helkowski, Richard A., Miller, John, Pierce, Ryan K., Sepetka, Ivan, Valley, Kristen.
Application Number | 20040098024 10/400185 |
Document ID | / |
Family ID | 28040930 |
Filed Date | 2004-05-20 |
United States Patent
Application |
20040098024 |
Kind Code |
A1 |
Dieck, Martin S. ; et
al. |
May 20, 2004 |
Containers and methods for delivering vaso-occluding filaments and
particles
Abstract
Containers for holding and delivering vaso-occluding materials,
such as hydrogel particles and filaments include a fluid inlet port
and a fluid outlet port that are respectively fluidly connectable
with a fluid source and a delivery catheter. The vaso-occlusive
materials may be held in the container in a hydrated or unhydrated
state. The container further includes at least one chamber or
passageway extending therebetween. The passageway may be straight,
curved, spiral, helical, narrow or otherwise shaped. The chamber
may also have sections of varying cross section such as a ramped
section. The shapes of the passageways of the container help
organize ejection of the vaso-occluding materials minimizing
contamination and clumping.
Inventors: |
Dieck, Martin S.;
(Cupertino, CA) ; Pierce, Ryan K.; (Mountain View,
CA) ; Helkowski, Richard A.; (Redwood City, CA)
; Miller, John; (Redwood City, CA) ; Sepetka,
Ivan; (Los Altos, CA) ; French, Ron; (Santa
Clara, CA) ; Valley, Kristen; (Mountain View,
CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Assignee: |
CONCENTRIC MEDICAL, INC.
Mountain View
CA
94043
|
Family ID: |
28040930 |
Appl. No.: |
10/400185 |
Filed: |
March 25, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10400185 |
Mar 25, 2003 |
|
|
|
10106483 |
Mar 25, 2002 |
|
|
|
Current U.S.
Class: |
606/200 |
Current CPC
Class: |
A61B 17/12113 20130101;
A61B 17/12022 20130101; A61B 17/12186 20130101; A61B 50/30
20160201; A61B 2017/1205 20130101; A61B 17/1219 20130101 |
Class at
Publication: |
606/200 |
International
Class: |
A61M 029/00 |
Claims
What is claimed is:
1. A kit for holding vaso-occluding elements comprising: a
plurality of hydratable vaso-occluding elements; and a container
adapted to hold the hydratable vaso-occluding elements, said
container having an inlet port and an outlet port, wherein at least
one of the fluid inlet and outlet ports is adapted for fluid
connection with a fluid source.
2. The kit of claim 1 wherein the container comprises a chamber to
hold said elements, said chamber having a varying cross sectional
area.
3. The kit of claim 2 wherein said varying cross sectional area
decreases in a direction from the inlet port to the outlet
port.
4. The kit of claim 2 wherein said chamber has a first section and
a second section and wherein said first section has a first cross
sectional area and said second section has a second cross sectional
area different than said first cross sectional area.
5. The kit of claim 4 wherein said second cross sectional area
decreases in a direction towards the fluid output port.
6. The kit of claim 5 wherein said first cross sectional area is
constant.
7. The kit of claim 1 comprising at least one passageway, said
passageway being adapted to allow a controlled number of elements
to pass therethrough at a time.
8. The kit of claim 7 wherein said passageway is straight.
9. The kit of claim 7 wherein said passageway is curved.
10. The kit of claim 9 wherein said passageway has one of a spiral
or helical shape.
11. The kit of claim 1 wherein said elements are particles and the
container further comprises a mixing member, said mixing member
being elongate and having a first section outside of said container
and a second section within said container for stirring said
particles.
12. The kit of claim 11 wherein said second section of said mixing
member includes fingers and wherein said mixing member is
rotatable.
13. The kit of claim 1 wherein said container comprises a conical
distal section, said conical distal section decreasing in diameter
and terminating at said fluid output port.
14. The kit of claim 13 wherein said conical distal section is
adapted to fit within a proximal end of a delivery catheter.
15. The kit of claim 1 further comprising a one-way valve
positioned at at least one of said fluid inlet port and fluid
output port wherein when said one-way valve is disposed at said
fluid inlet port the valve permits flow only into said container
and when said valve is positioned at said fluid output port said
valve permits flow only out of said container.
16. The kit of claim 1 wherein said elements are particles and said
container further comprises first chamber in fluid communication
with said inlet port and a second chamber in fluid communication
with said outlet port, said first chamber and said second chamber
separated by a support member having at least one opening and said
at least one opening being larger than said particles such that
when said at least one opening is not covered, fluid and said
particles may pass through, said container further comprising a
movable screen positioned across said support, said screen having
at least one particle-blocking section and at least one
particle-passing section, said particle-blocking section having a
plurality of apertures smaller than said particles and said
particle-passing section having at least one aperture larger than
said particles, said screen being movable such that when said
particle-passing section of said movable screen is aligned with
said opening of said support said particles may enter said second
chamber and when said particle-passing section of said movable
screen member is not aligned with said at least one opening of said
support said particles may not enter said second chamber.
17. The kit of claim 1 wherein said container further comprises a
screen member disposed across said outlet, said screen member
having a plurality of apertures and each of said apertures being
smaller than said elements such that said elements may not pass
through said outlet.
18. The kit of claim 1 wherein said elements comprise
polyacrylonitrile.
19. The kit of claim 18 wherein said elements comprise spherical
particles.
20. The kit of claim 19 wherein said particles have an outer
diameter in the range of 40 .mu.m to 2 mm.
21. The kit of claim 1 further comprising a liquid in said
container and wherein said elements are hydrated.
22. The kit of claim 1 further comprising at least one cap covering
one of said fluid inlet port and fluid outlet port.
23. The kit of claim 1 further comprising a Luer fitting for
connecting said fluid source to said fluid inlet port.
24. The kit of claim 1 further comprising a Luer fitting for
connecting said outlet port with a delivery catheter.
25. The kit of claim 1 wherein said container further comprises at
least one fluid relief port and at least one fluid relief
passageway connected to said fluid relief port wherein said at
least one fluid relief port has a diameter less than the diameter
of said elements and wherein liquid driven through said container
flows through said chamber and said fluid relief passageway while
said elements flow only through said chamber to said fluid outlet
port.
26. A kit comprising: at least one hydratable vaso-occluding
filament; and a container hold adapted to hold the filament and
having an inlet and an outlet wherein at least one of the inlet and
outlet is adapted for connection to a fluid source.
27. The kit of claim 26 wherein the inlet is adapted to receive a
fluid source and the outlet is adapted for connection to a delivery
catheter.
28. The kit of claim 27 wherein said fluid source is a syringe.
29. The kit of claim 26 wherein said filament comprises
polyacrylonitrile.
30. The kit of claim 26 wherein said container comprises a
passageway having a cross-sectional geometry which allows only one
filament of occluding material to pass through at a time.
31. The kit of claim 30 wherein said filament has a diameter in the
range of 100 .mu.m to 5 mm.
32. The kit of claim 30 wherein said passageway is at least partly
straight.
33. The kit of claim 30 wherein said passageway is at least partly
curved.
34. The kit of claim 33 wherein said passageway is spiral or
helical over at least a portion of its length.
35. The kit of claim 26 wherein said container has a shape selected
from the group consisting of disk-, card-, cylindrical-, and
turnip-shape.
36. The kit of claim 26 wherein said container further comprises a
membrane, said membrane having openings sized to prevent said
filament material from passing therethrough but allowing liquid to
pass therethrough.
37. The kit of claim 26 wherein the container comprises a rotatable
barrel having multiple passageways for holding filaments, and a
body having a single ejection channel wherein when one of the
multiple passageways is aligned with said single channel a fluid
pathway is formed connecting the fluid source to the outlet port of
the container.
38. The kit of claim 26 further comprising a displacement member
for pushing the filament material out the container.
39. A method for introducing vaso-occluding elements into a
delivery catheter comprising: hydrating the elements in a
container, said container having another end adapted for fluid
connection with a delivery catheter; and pushing at least a portion
of the material from the container through the catheter and to a
target site.
40. The method of claim 39 wherein said pushing comprises attaching
a fluid source to an inlet end of the container and applying fluid
pressure from the fluid source.
41. The method of claim 39 wherein said elements comprise at least
one filament.
42. The method of claim 41 wherein said pushing is performed with
an elongated displacement member.
43. The method of claim 41 further comprising the step of severing
the filament at a selected location along the length of the
filament.
44. The method of claim 43 wherein said severing is performed by
pinching the filament at said location between two surfaces.
45. The method of claim 44 wherein said pinching is performed using
an expandable balloon.
46. The method of claim 43 wherein said breaking is performed using
a noose.
47. The method of claim 41 wherein said filament includes discrete
sections having an enlarged diameter.
48. The method of claim 47 further comprising detecting the
sections of enlarged diameter and breaking the filament in response
to the detecting.
49. The method of claim 43 wherein the breaking is distal to the
distal end of the delivery catheter.
50. The method of claim 43 wherein the breaking is performed in the
container.
51. The method of claim 39 further comprising purging the container
with a therapeutic liquid and using said therapeutic liquid for
pushing.
52. A container for holding hydratable vaso-occluding elements,
said container comprising: a delivery tube having an inlet end, a
delivery end, a lumen extending from the inlet end to the delivery
end, a length from inlet end to delivery end of at least 5 cm and a
maximum lumen width along its length in the range from 0.4 mm to 5
mm; and an inlet coupling disposed on the inlet end of the delivery
tube, said inlet coupling being adapted to fluidly couple to a
fluid source; wherein the delivery tube is configured to reduce the
length of the container.
53. A container as in claim 52, wherein the inlet coupling is a
Luer connector adapted to connect to a syringe.
54. A container as in claim 52, wherein the delivery tube is
configured as a helix over at least a portion of its length.
55. A container as in claim 54, wherein the helix is wound over a
cylindrical barrel.
56. A container as in claim 54, wherein the helix is wound inside
of a cylindrical barrel.
57. A container as in claim 52, wherein the delivery tube is
configured as a planar spiral over at least a portion of its
length.
58. A container as in claim 57, wherein the planar spiral is formed
over a planar card.
59. A container as in claim 52, wherein the delivery tube is
configured in a serpentine pattern over at least a portion of its
length.
60. A container as in claim 52, further comprising a plurality of
hydratable vaso-occluding particles contained in the lumen of the
delivery tube.
61. A container as in claim 60, wherein the particles have an
average diameter of 75 .mu.m to 1.5 mm.
62. A container as in claim 60, wherein the particles are not
hydrated.
63. A container as in claim 60, wherein the particles are hydrated
in a hydrating medium in the lumen.
64. A container as in claim 52, further comprising at least one
hydratable vaso-occluding filament contained in the lumen of the
delivery tube.
65. A container as in claim 64, wherein the filament has a length
in the range from 1 cm to 2000 cm and a width in the range from 75
.mu.m to 5 mm.
66. A container as in claim 65, wherein the filament is not
hydrated.
67. A container as in claim 65, wherein the filament is hydrated in
a hydrating fluid in the lumen.
68. A container as in claim 52, wherein the delivery end of the
delivery tube is straight over a length of at least 1 cm and
adapted to be received in a hub of a delivery catheter.
69. A container as in claim 68, wherein the straight delivery end
of the delivery tube is tapered to form a seal with a tapered
passage in the hub of the delivery catheter.
70. A container as in claim 68, wherein a spherical seal is formed
over the straight delivery end of the delivery tube to form a seal
with a tapered passage in the hub of the delivery catheter.
71. A method for introducing vaso-occluding elements into an
implanted catheter, said method comprising: providing said elements
in a hydration liquid in a delivery tube having a lumen with a
length of at least 2 cm and a maximum width along its length in the
range from 0.4 mm to 5 mm; mating a delivery end of the tube with a
hub of the implanted catheter; and transferring said element(s) in
the hydration liquid from the lumen and through the delivery end of
the delivery tube into a lumen of the implanted catheter.
72. A method as in claim 71, wherein the delivery tube is
configured as a helix over at least a portion of its length.
73. A method as in claim 72, wherein the helix is wound over a
cylindrical barrel.
74. A method as in claim 72, wherein the helix is wound inside of a
cylindrical barrel.
75. A method as in claim 71, wherein the delivery tube is
configured as a planar spiral over at least a portion of its
length.
76. A method as in claim 75, wherein the planar spiral is formed
over a planar card.
77. A method as in claim 72, wherein the delivery tube is
configured in a serpentine pattern over at least a portion of its
length.
78. A method as in claim 71, wherein providing comprises drawing
said elements from a pool of hydrated elements into the lumen of
the delivery tube.
79. A method as in claim 78, wherein the elements comprise a
filament and drawing comprises applying a vacuum on an inlet end of
the delivery tube to capture an end of the filament and draw the
length of the filament into the lumen.
80. A method as in claim 79, further comprising priming the
delivery tube lumen with the hydration liquid from a syringe and
then using the syringe to apply the vacuum.
81. A method as in claim 79, wherein the filament has a length in
the range from 1 cm to 2000 cm and a width along their length in
the range from 75 .mu.m to 5 mm.
82. A method as in claim 71, wherein the delivery tube is provided
as a sterile package with the elements in the lumen.
83. A method as in claim 82, wherein the elements are not hydrated
in the sterile package, and providing comprises drawing the
hydration liquid into the delivery tube.
84. A method as in claim 83, wherein the elements are present in
the hydration liquid in the sterile package.
85. A method as in claim 71, wherein mating comprises forming a
seal between the delivery end of the delivery tube and a passage of
the catheter hub.
86. A method as in claim 85, wherein mating comprises engaging a
tapered region of the delivery end in a tapered passage of the
catheter hub to form a seal between the delivery tube lumen and the
catheter lumen.
87. A method as in claim 85, wherein mating comprises engaging a
plug element on the delivery end in a tapered passage of the
catheter hub.
88. A method as in claim 85, wherein mating comprises forming a
hemostatic seal over the exterior of the delivery end of the
delivery tube and extending to the catheter hub.
89. A method as in claim 71, wherein transferring comprises
applying pressure at an inlet end of the delivery tube lumen.
90. A method as in claim 71, wherein transferring comprises passing
a push rod through an inlet end of the delivery tube lumen and
pushing the elements with the rod.
91. A system for delivering vaso-occluding elements, said system
comprising: at least one hydratable vaso-occluding element having a
width when hydrated; and a delivery tube having an inlet end, a
delivery end, and a lumen extending from the inlet end to the
delivery end; wherein the lumen of the delivery tube is adapted to
hold said hydratable vaso-occluding element and has a width along
its length which is at least as large as the width of the
vaso-occluding element and less than twice the width of the
vaso-occluding element.
92. A system as in claim 91, wherein the hydratable vaso-occluding
element comprises at least one filament.
93. A system as in claim 91, wherein the hydratable vaso-occluding
element comprises a plurality of particles.
94. A method for delivering hydratable vaso-occluding elements to a
target body location, said method comprising singly dispensing one
or more vaso-occluding elements through a delivery tube to a
catheter lumen, wherein the lumen of the delivery tube is adapted
to pass only a single vaso-occluding element at a time.
95. A method as in claim 94, wherein the vaso-occluding elements
are dispensed with a hydrating fluid into the catheter lumen.
96. A method as in claim 95, wherein the hydratable vaso-occluding
elements are filaments.
97. A method as in claim 95, wherein the hydratable vaso-occluding
elements are particles.
Description
CROSS REFERENCE
[0001] This application is a continuation-in-part of application
Ser. No. 10/106,483 (atty. docket no. 21186-000400US), filed on
Mar. 25, 2002, the full disclosure of which is incorporated herein
by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention.
[0003] The present application is directed generally at medical
devices and methods and, more particularly, containers and methods
for holding and delivering vaso-occluding filaments and
particles.
[0004] Numerous persons experience some form of hemorrhagic stroke
or blood vessel rupture in the brain. Ruptures can occur with a
number of abnormalities including arterio venous malformations
(AVM), aneurysms (a ballooning of the arterial wall), fistulas, or
a burst blood vessel. Additionally, abnormal vasculature is
generated in the process of tumor growth requiring larger than
normal blood flow to sustain the tumor.
[0005] Endovascular therapies for treating vessel ruptures and
blood flow abnormalities include implanting vaso-occlusive agents,
coils and other devices such as that described in U.S. Pat. No.
4,994,069, and injecting hydrogel vaso-occluding particles and
filaments into the vessels to be treated, as described in U.S.
Patent Application Publication Nos. 2002/0193813A1; 2003/004533A1;
2003/0004568A1; and 2002/0193812A1, each of which are assigned to
the assignee of the present application and are hereby incorporated
by reference in their entirety.
[0006] Injecting vaso-occluding materials, however, requires
careful handling in order to avoid various problems. For example,
the particles and filaments may clump and clog the lumens and
openings of the dispensing containers and instruments. The small
size of the particles and filaments makes them inconvenient for a
doctor to handle. In particular, capturing/collecting a filament in
a solution is difficult due to their small size. The vaso-occluding
material may be contaminated during the mixing or transporting
step. The vaso-occluding materials may become damaged during
shipping and storing. For example, when hydrogel filaments are
shipped in an unhydrated state, they tend to be brittle. Such
filaments are particularly vulnerable to breaking during
shipping.
[0007] For these reasons, it would be desirable to provide improved
apparatus and methods for delivering vaso-occluding elements,
particularly hydratable particles and filaments. The apparatus and
methods should avoid clumping and tangling of the vaso-occluding
elements prior to and during delivery and should further avoid
clogging of the delivery apparatus during delivery. In particular,
the methods and apparatus should in at least some instances permit
delivery of individual vaso-occluding elements singly, i.e. one at
a time. The apparatus and methods should also facilitate and
improve the collection and storage of the vaso-occluding elements
prior to use. It would be further desirable to provide for storage
of the vaso-occluding elements in either a hydrated or non-hydrated
condition and, in the latter case, permit convenient hydration in
the storage container prior to use. In all cases, it would be
desirable that the stored vaso-occluding elements be protected
during storage and shipment. At least some of these objectives will
be met by the invention described hereinafter.
BRIEF SUMMARY OF THE INVENTION
[0008] Described herein are kits, containers and methods for
holding and delivering vaso-occluding elements, including both
filaments and particles. In one variation, the kit comprises a
plurality of hydratable vaso-occluding elements and a container
holding the hydratable vaso-occluding elements. The container has
an inlet port and an outlet port. At least one of the fluid inlet
and outlet ports is adapted to fluidly connect with a fluid source,
typically a pressurized fluid source such as a syringe. The fluid
inlet port may be configured for receiving liquid to hydrate the
vaso-occluding particles and the fluid output port may be
configured for dispensing the liquid and the vaso-occluding
particles, typically into an implanted catheter having delivery to
a target location in a patient's body.
[0009] The container will usually include at least one chamber or
passageway to hold the particles. The passageway or chamber may
have various shapes. For example, the passageway may be straight,
curved, conical, narrow, spiral, helical and otherwise shaped. The
container and/or chamber(s) and passageway(s) may have multiple
sections and the sections may have varying cross sectional areas.
The various constructs of the chamber facilitate introduction of
the particles into the delivery catheter.
[0010] The characteristics of the elements may vary. In one
variation, the elements are particles having an outer width or
diameter in the range of 40 .mu.m to 2 mm, usually 100 .mu.m to
1400 .mu.m. In another variation, the elements are filaments,
typically having a length in the range from 0.5 mm to 1000 mm,
usually from 10 mm to 1000 mm, and often from 10 mm to 100 mm, and
a width or diameter in the range from 75 .mu.m to 5 mm, usually
from 100 .mu.m to 2 mm, and often from 100 .mu.m to 1 mm. The
elements will be hydratable, i.e. capable of absorbing saline or
other aqueous medium (referred to hereinafter as a hydration or
hydrating medium), typically being formed from a polymeric hydrogel
material, more typically being formed from a natural or synthetic
polymer. A particularly preferred polymer is polyacrylonitrile, but
a variety of other suitable polymers are listed hereinbelow.
[0011] In another variation, the elements are particles and the
container includes a mixing member. The mixing member may be
elongate and have a first section outside of the container and a
second section with, for example, a stirrer that contacts and moves
the particles when the stirrer is rotated.
[0012] Another container includes a conical distal end section. The
conical distal end section decreases in diameter towards the fluid
outlet port. The conical portion may be sized to fit within the
proximal end of a delivery catheter.
[0013] Another container includes at least one fluid relief port
and at least one fluid relief passageway fluidly connected with the
fluid relief port. The fluid relief port may have a size smaller
than that of the particles such that the particles cannot pass
therethrough. The fluid relief passageways may extend to the fluid
outlet port such that liquid driven through the container flows
through the chamber and the fluid relief passageway while the
particles are permitted only to flow through the chamber.
[0014] In another variation, the container may include at least one
one-way valve.
[0015] In another variation, the container includes a membrane or
screen. For example, the container may comprise a first chamber in
fluid communication with an inlet port and a second chamber in
fluid communication with an outlet port. The first chamber and the
second chamber may be separated by a support member having at least
one opening larger than the vaso-occluding particles or filaments.
When the opening is not covered, fluid and the occluding materials
may pass through. The container may further comprise a movable
screen positioned across the support and the screen may include at
least one particle-blocking section and at least one
particle-passing section. The particle-blocking section has a
plurality of apertures smaller than the particles and the
particle-passing section has at least one aperture larger than the
particles. The screen is movable such that when the
particle-passing section of the movable screen is aligned with the
opening of the support the particles may enter the second chamber.
Also, when the particle-passing section of the movable screen
member is not aligned with the opening of the support the particles
may not enter the second chamber.
[0016] In another variation, the container may include a fluid
outlet and a screen member disposed across the outlet. The screen
member may be fixed and the outlet may be coverable. The screen
member may have a plurality of apertures and each of the apertures
is smaller than the particles or filaments such that the particles
may not pass through the outlet.
[0017] A kit may also include a cap to cover one or both of the
fluid inlet and fluid outlet ports. Additionally, the fluid inlet
and fluid outlet ports may have Luer-type or other threaded fitting
to fluidly connect the syringe and delivery catheter to the
container.
[0018] Another kit comprises a hydratable filamentary occluding
material and a container holding the material. The material may
comprise polyacrylonitrile. The container may have a first opening
for fluid flow and a second opening for fluid flow and exit of the
filamentary occluding material. At least one of the openings may be
adapted for connection to a fluid source such as a syringe.
[0019] Also, one of the first and second openings may be adapted
for connection with a delivery catheter. The container may further
include at least one chamber or passageway to hold the fluid and
the filaments.
[0020] The passageway or chamber may be variously shaped. For
example, the passageway may be straight, curved, conical, narrow,
spiral, helical and otherwise shaped. The container may have
multiple sections and the sections may have varying cross sectional
areas. The various constructs of the chamber facilitate
introduction of the particles into a delivery catheter.
[0021] In another variation, the passageway of the container is
configured to allow only one filament of occluding material pass
therethrough at a time. The diameter of the passageway may be in
the range of 100 .mu.m to 5 mm.
[0022] Also, the shape of the container itself may vary. The
container may have, for example, a disk-, card-, cylindrical-, or
turnip-shape. The container may also include a screen or membrane.
The membrane may have openings sized to prevent the filament
material from passing therethrough but allow liquid to pass
therethrough.
[0023] Another container includes a rotatable barrel. The barrel
may have multiple passageways for holding filaments and a body
having a single ejection channel. To deliver a selected filament,
one of the multiple passageways is aligned with the channel such
that a fluid pathway is formed from the fluid source to the outlet
port of the container.
[0024] A method for holding and introducing vaso-occluding
materials into a delivery catheter is also provided herein. The
method may include the steps of hydrating the material in a
container and pushing at least a portion of the material from the
container, to a target site. The pushing step may be performed
using fluid pressure or a displacing member. The occluding
materials may be a filament.
[0025] The method may also include the additional step of severing
the filament at a selected location along the length of the
filament. The severing may be performed e.g., by pinching, cutting,
ablating, twisting, pulling, or similarly detaching the filament.
The pinching may be performed using an expandable balloon. Also,
the breaking may be performed using a noose or snare. The point of
severing may be distal or proximal to the distal end of the
catheter and perhaps, within the container.
[0026] Yet another method includes an additional step of detecting
discrete sections of the filament along its length. The sections
may be marked or enlarged to provide information or feedback to a
doctor or physician. The filament may then be broken at a selected
point upon detecting a certain number of segments. The point of
severing may be distal or proximal to the distal end of the
catheter and perhaps, within the container.
[0027] A preferred container for holding hydratable vaso-occluding
elements comprises a delivery tube having an inlet end, a delivery
end, and a lumen extending from the inlet end to the delivery end.
The delivery tube has a length of at least 5 cm, typically being
from 10 cm to 10 m, usually from 20 cm to 1 m, and often from 100
cm to 500 cm, and the lumen has a maximum width along the length in
the range from 75 .mu.m to 5 mm, typically from 250 .mu.m to 2 mm.
The lumen of the delivery tube provides the passageway or chamber
for holding the hydratable elements, and its narrow, elongated
configuration is particularly useful since it permits the
controlled delivery and dispensing of the elements. In particular,
the length and width of the lumen may be selected to receive single
filaments in a manner where the filaments do not fold on themselves
or otherwise become clogged or restricted within the lumen.
Similarly, the luminal dimensions can be selected to permit
arrangement and dispensing of particles in a single file, i.e.
where the width of the lumen is equal or greater than the particle
width but limited to permit passage of only a single element at a
time, e.g., being less than twice the particle width, so that
particles may not pass each other in the lumen.
[0028] The delivery tube will further include an inlet coupling
disposed on the inlet end, where the inlet coupling is adapted to
be fluidly coupled to a syringe or other fluid source, typically
being a Luer fitting. As the delivery tube is typically lengthy, it
will usually be configured to reduce its length, typically having
at least a portion configured as a helix, spiral, serpentine
structure, or other folded or meandering path which will reduce the
container length while maintaining the length of the delivery tube
lumen. Depending on the pattern in which the delivery tube is
configured, the delivery tube may be mounted on various substrates
or matrices. For example, helical delivery tubes may be wound over
a cylindrical barrel, be wound inside of a cylindrical barrel, or
the like. Spiral and serpentine delivery tubes may be mounted on
planar cards. The containers and the hydratable elements may be
supplied to the user separately, but will more usually be supplied
in combination. For example, the hydratable vaso-occluding elements
may be stored or maintained within the delivery tube lumen in a
hydrated state, a partially hydrated state, or a non-hydrated
state. In all cases, both the container and the hydratable elements
will be sterile and maintained in a sterile package, such as a
pouch, tube, box, blister card, or the like. Alternatively, the
container and the vaso-occluding elements may be packaged in
separate sterile containers, where the vaso-occluding elements
again may be maintained in a hydrated, partially hydrated, or
non-hydrated state. In all cases, when the vaso-occluding elements
are provided in a non-hydrated or partially-hydrated state, it will
be necessary to combine and mix the particles with a suitable
hydrating medium, which medium may also be provided as part of the
kit or system.
[0029] In preferred constructions, the delivery tube of the
container will have a generally straight end formed over a length
of at least 1 cm, where the straight end is adapted to be received
in a hub of a delivery catheter, such as a micro catheter having a
hub passage with a diameter in the range from 0.4 mm to 5 mm,
typically from 0.5 mm to 1.5 mm. Usually, the hub passage which
receives the end of the delivery tube will be tapered. In some
instances, the straight delivery end of the delivery tube will also
be tapered in order to mate with and form a seal with the tapered
passage of the hub. Alternatively, a spherical or other seal may be
provided over the straight end of the delivery tube in order to
provide a seal with the passage in the hub of the delivery
catheter.
[0030] In another preferred aspect of the present invention, a
method for introducing vaso-occluding elements into an implanted
catheter comprises providing said elements in a hydration liquid in
a delivery tube having the dimensions set forth above. The delivery
end of the delivery tube is mated with the hub of an implanted
catheter, and the elements in the hydration liquid are transferred
from the lumen and through the delivery end of the delivery tube
into a lumen of the implanted catheter. The elements may thus be
delivered to any target site in the body to which the implanted
catheter is directed. The methods of the present invention may
employ delivery tubes configured in any of the geometries described
above in connection with the apparatus of the present
invention.
[0031] In preferred aspects of the method, providing may comprise
drawing said elements from a pool of hydrated elements into the
lumen of the delivery tube. For example, when the elements comprise
filament(s), drawing may comprise applying a vacuum on an inlet end
of the delivery tube to capture an end of the filament and draw the
length of the filament into the lumen of the delivery tube.
Usually, the lumen will have been primed with the hydration liquid
using a syringe, where the syringe is the used to apply the vacuum
to capture the filament. Alternatively, the delivery tube may be
provided as a sterile package with the elements in the lumen,
either in a hydrated, partially hydrated, or non-hydrated form.
[0032] Mating of the delivery end of the delivery tube with the hub
passage usually comprises forming a seal between the delivery end
of the delivery tube and the passage of the catheter hub. The seal
may be formed by engaging a tapered region of the delivery end in a
tapered passage of the catheter hub. Alternatively, sealing may be
performed by mating a spherical seal, plug element typically on the
delivery end of the delivery tube in a tapered passage of the
catheter hub. Still further alternatively, mating may comprise
forming a hemostatic seal over an exterior of the distal end of the
delivery tube, where the seal extends to the passage of the
catheter hub.
[0033] After the delivery end of the delivery tube has been mated
and sealed with the catheter hub, the vaso-occluding elements are
transferred to a catheter lumen, typically by applying pressure at
an inlet end of the delivery tube lumen. Pressure causes the fluid
and vaso-occluding elements to flow into the lumen of the delivery
catheter. Alternatively, transfer may be achieved by passing a
pushrod through an inlet end of the delivery tube lumen and pushing
the elements with the rod. The latter approach provides for precise
transfer of the vaso-occluding elements, particularly for filaments
where the length delivered from the delivery end of the catheter
may be carefully monitored and controlled.
[0034] In yet another aspect of the present invention, a system for
delivering vaso-occluding elements comprises at least one
hydratable vaso-occluding element having a width when hydrated. A
delivery tube having an inlet end, a delivery end, and a lumen
extending from the inlet end to the delivery end is adapted to hold
the hydratable vaso-occluding element(s). In order to avoid
tangling of individual filaments and to assure single-file delivery
of multiple particles and filaments, the lumen of the delivery tube
has a width along its length which is at least as large as the
width of the vaso-occluding element and typically (although not
necessarily) less than twice the width of the vaso-occluding
element.
[0035] In yet another aspect, methods according to the present
invention for delivering hydratable vaso-occluding elements to a
target body location comprise singly dispensing one or more
vaso-occluding elements through a delivery tube to a catheter
lumen. The lumen of the delivery tube is adapted to pass only a
single vaso-occluding element at a time past any point in the
lumen. Thus, the vaso-occluding elements may be dispensed with a
hydrating fluid into the catheter lumen one at a time. The method
can be employed with both filaments and particles.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] FIG. 1 is a perspective view of a container.
[0037] FIG. 2 is an illustration of a catheter assembly.
[0038] FIG. 3a is an illustration of an application showing
vaso-occluding particles being delivered to a plurality of blood
vessels for treatment of a tumor.
[0039] FIG. 3b is an illustration of another application showing
vaso-occluding particles being delivered to an aneurysm.
[0040] FIG. 4 is an exploded view of a catheter assembly.
[0041] FIGS. 5a-5n are partial cross sectional views of various
containers for holding vaso-occluding particles.
[0042] FIGS. 6a-6k are partial cross sectional views of various
containers for holding vaso-occluding elements.
[0043] FIG. 7a is a partial cross sectional view of another
catheter assembly having a rotatable multi-passageway
container.
[0044] FIG. 7b is a cross sectional view of the container shown in
FIG. 7a taken along line 7B-7B.
[0045] FIG. 7c is a cross sectional view of the container shown in
FIG. 7a taken along line 7C-7C.
[0046] FIG. 7d is a cross sectional view of yet another catheter
assembly having a planar-shaped multi-passageway container.
[0047] FIGS. 8a-8d are illustrations of various techniques for
breaking or severing a filament.
[0048] FIGS. 9 and 10 illustrate a preferred embodiment of a
container system constructed in accordance with the principles of
the present invention. FIG. 9 shows system components in an
exploded view, while FIG. 10 shows the system in an assembled
view.
[0049] FIGS. 11A and 11B illustrate alternative delivery
tube-catheter hub interface configurations taken along line 11-11
of FIG. 10.
[0050] FIGS. 12A and 12B illustrate an exemplary method according
to the present invention for capturing and loading a filament into
the container system of FIGS. 10 and 11.
[0051] FIGS. 13 and 14 illustrate alternative delivery tube
configurations which could be used with the container system of
FIGS. 10 and 11.
DETAILED DESCRIPTION OF THE INVENTION
[0052] Described below are containers and methods for holding and
delivering vaso-occluding materials to a target site.
[0053] FIGS. 1-2 illustrate one variation of a container. In
particular, a barrel-shaped container (10) is shown holding
vaso-occluding materials (12) described further below. The
container (10) includes a fluid inlet port (14), which can be
removably connected to a fluid source such as a syringe (18). The
container (10) further includes a fluid outlet port (16) which can
be removably connected with a vaso-occlusive delivery device such
as delivery catheter (20).
[0054] During operation, fluid pressure from the syringe drives the
vaso-occluding materials from the container (10) into the delivery
catheter (22). Fluid pressure is further supplied to urge the
vaso-occluding materials through the delivery catheter and out its
distal end (22). In this manner, vaso-occluding materials are
delivered to a target site. Target sites include, but are not
limited to, the abnormal vasculature of a tumor, aneurysms and
other sites of abnormal blood flow as well as vessels, ducts and
cavities that are not part of the blood vascular system.
Vaso-Occluding Elements and Materials
[0055] The containers described herein may hold and introduce
vaso-occluding elements and materials into a delivery catheter. The
vaso-occluding elements include but are not limited to
vaso-occluding particles (e.g. biocompatible polymeric
microspheres) and vaso-occlusive filaments and filamentary
materials (e.g., hydrophilic polyacrylonitrile or HYPAN). The
vaso-occluding elements may be made from a variety of substances
including hydrogel polymers and other polymers. Examples of
hydrogel polymers and polymers include: polyacrylamide (PAAM), poly
(N-isopropylacrylamine) (PNIPAM), poly (vinylmethylether), poly
(ethylene oxide), poly (vinylalcohol), poly (ethyl (hydroxyethyl)
cellulose), poly(2-ethyl oxazoline), Polylactide (PLA),
Polyglycolide (PGA), Poly(lactide-co-glycolide) PLGA,
Poly(e-caprolactone), Polydiaoxanone, Polyanhydride, Trimethylene
carbonate, Poly(.beta.-hydroxybutyrate), Poly(g-ethyl glutamate),
Poly(DTH-iminocarbonate), Poly(bisphenol A iminocarbonate),
Poly(orthoester) (POE), Polycyanoacrylate (PCA), Polyphosphazene,
Polyethylenoxide (PEO), Polyethlglycol (PEG), Polyacrylacid (PAA),
Polyacrylonitrile (PAN), Polyvinylacrylate (PVA),
Polyvinylpyrrolidone (PVP), a co-polymer of two or more polymers,
and a blend of two or more polymers.
[0056] The hydrogel polymer or polymers may also comprise a natural
polymer. Examples of natural polymer include collagen, silk,
fibrin, gelatin, hyaluron, cellulose, chitin, dextran, casein,
albumin, ovalbumin, heparin sulfate, starch, agar, heparin,
alginate, fibronectin, fibrin, keratin, pectin, elastin, and
copolymers and blends of the polymers.
[0057] Alternatively, the materials may comprise a bioactive agent
and or a radio-pacifier to facilitate visualization of the
vaso-occluding materials at a target site.
[0058] A particular element which may be used in conjunction with
the containers described herein is a hydrogel filament. In one
variation, the filament is comprised of an extruded
polyacrylonitrile. One way of fabricating such a filament is by the
process of dissolving the polyacrylonitrile in DMSO and extruding
it into an alcohol bath, whereupon the polyacrylonitrile solution
forms a filament. The filament is then removed from the alcohol
(e.g. isopropyl or like alcohol) and allowed to dry. Prior to
implantation in a patient the filament may be hydrated.
Alternatively, the filament may be stored in a hydrated state. The
filament can then be injected or delivered in a delivery tool to a
chosen site in the patient. The hydrated filament forms a
vaso-occlusive filamentous mass and occludes normal flow.
[0059] Dimensions for the vaso-occlusive devices may be as desired
for a specific purpose, but generally would be in a range from
about 0.005 inches (0.125 mm) to about 0.50 inches (12.5 mm). The
diameter of the occluding particles will typically be in the range
of 40 .mu.m to 2 mm, usually from 100 .mu.m to 1400 .mu.m. The
filaments and other occluding filamentary materials may have a
diameter in the range of 75 .mu.m to 5 mm, usually 100 .mu.m to 2
mm, more usually from 100 .mu.m to 1 mm. Also, the diameter of the
vaso-occlusive materials may be selected such that they may pass
through a delivery device such as a delivery catheter. The lengths
of the vaso-occlusive filaments as delivered may be generally in
the range from about 0.5 mm to about 5 meters, usually being from
0.5 mm to 1 meter, typically being from 10 cm to 100 cm. The width
or diameter of the vaso-occlusive element once it is delivered and
after it has assumed its vaso-occluding shape (i.e., the deployed
filament) may be in a range from about 75 .mu.m to about 5 cm.
[0060] A description of particular hydrogel materials may be found
in U.S. Patent Application Publication Nos. 2002/0193813A1;
2003/004533A1; 2003/004568A1; and 2002/0193812A1, each of which are
assigned to the assignee of the present application and hereby
incorporated by reference in their entirety.
Procedural Overview of Vaso-Occluding Treatments
[0061] FIGS. 3a-3b show examples of deploying vaso-occlusive
particles. Referring to FIG. 3a, a tumor (50) is shown being
treated with vaso-occluding particles (60). In particular,
vaso-occluding particles such as the hydrogel particles discussed
above are shown being delivered from a delivery catheter (62) to
various blood vessels (64) supplying blood to the tumor (50). The
vaso-occluding particles form blockages in the vessels (64) leading
to the tumor. Accordingly, the blood to the tumor is cut off,
inhibiting tumor growth.
[0062] FIG. 3b illustrates treatment of an aneurysm (70). In FIG.
3b, vaso-occluding particles (72) are delivered into the aneurysm
(70). The vaso-occluding particles form an occlusive mass in the
aneurysm, minimizing its undesirable effects on the artery.
[0063] Also, instead of (or in addition to) vaso-occluding
particles, occluding filaments may be supplied to form blockages in
the vessels or an occlusive mass in the aneurysm.
[0064] It is to be understood, however, that the containers and
occluding materials described herein are not limited to occluding
blood vessels or aneurysms. Rather, the containers and occluding
materials described herein may be used to form occlusions in any of
the vessels, ducts, and cavities found in the body including but
not limited to vessels found in the blood vasculature.
[0065] In both FIGS. 3a and 3b, the distal tip of a delivery
catheter (62, 74) is positioned near the target site via a
catheterization procedure. One catheterization procedure for
treatment of various vascular defects includes inserting a sheath
into an artery such as the femoral artery. Inserting a guidewire
into the sheath and advancing the guidewire to the desired site
such as a tumor or aneurysm. Next, a catheter assembly including an
elongate introducer catheter is inserted into the sheath and the
catheter assembly is advanced over the guidewire to the target
site. Once the catheter assembly is properly positioned at the
target site, the guidewire is removed from the introducer catheter.
A delivery catheter is then inserted within the introducer catheter
until the distal end of the delivery catheter is positioned at the
site to be embolized. Vaso-occluding materials are fed into the
delivery catheter and delivered to the treatment site.
[0066] Additional examples of catheter assemblies are discussed in,
for example, U.S. Pat. Nos. 5,382,260 and 5,476,472. Also, other
catheter assemblies known to those of skill in the art may be used
in conjunction with the delivery devices and occluding materials
described herein. Devices and methods for treating aneurysms and
the like are also described in U.S. application Ser. No. 10/106,870
filed Mar. 25, 2002 entitled "Devices And Methods For Treating
Vascular Malformations" by Sepetka et al. which is a continuation
in part application of U.S. application Ser. No. 09/695,637, filed
Oct. 24, 2000, which is a continuation in part of U.S. application
Ser. No. 09/324,359 filed Jun. 2, 1999, each of which is
incorporated by reference in its entirety.
[0067] Vaso-occluding materials may be delivered to a treatment
site through a delivery catheter. An example of a particular
delivery catheter assembly (400) for use with the present invention
is shown in FIG. 4 and includes a syringe (410), a cartridge or
container (420) and a delivery catheter (430). The delivery
catheter assembly shown in FIG. 4 shows the cartridge separated
from the syringe. However, the invention is not so limited and the
cartridge may be integrally connected with the syringe. In yet
another variation, the cartridge is integral with the delivery
catheter (430). Kits may also be provided having a cartridge with a
plurality of vaso-occluding particles and or a hydrating liquid
contained therein.
[0068] To reiterate, these various containers and cartridges may be
connectable with a delivery catheter. As described, vaso-occluding
materials held in the containers may be hydrated, washed, or mixed
in the container. The vaso-occluding materials may then be injected
into the delivery catheter by fluid pressure or some other way such
as by use of a displacement wire for implantation in a target
treatment site. The containers may have fluid inlet and outlet
ports and at least one passageway connecting the fluid inlet port
to the fluid outlet port. The shapes, number of passageways, and
other features of the containers may take various configurations,
discussed below.
Containers for Holding Vaso-Occluding Particles
[0069] FIG. 5a illustrates a container (510) having a cylindrical
shape for holding vaso-occlusive materials. The container includes
a fluid inlet port (512) and fluid outlet port (514). The fluid
inlet port and the fluid outlet port are adapted to fluidly connect
the container to a syringe and delivery catheter respectively. The
ends of the container may have Luer-type fittings for convenient
assembly with the syringe and delivery tool.
[0070] In this variation, the container includes a chamber or
passageway (516) fluidly connecting the fluid inlet port and the
fluid outlet port. A liquid (518) and vaso-occluding particles
(520) are held in the chamber (516). The particles are urged
towards the fluid outlet port (514) by fluid pressure and flow. The
vaso-occluding particles are injected into, for example, a delivery
catheter (not shown) through the fluid outlet port.
[0071] The container may be made of various materials such as but
not limited to polymers, copolymers, glass, metals or alloys. For
example, the container may be made of a transparent polymer
material such as clear polycarbonate. The container may be
fabricated in components or sections and bonded together using heat
treatment, adhesives and ultrasonic welding, for example. The
container and its components may be, for instance, injection
molded, machined and micromachined. Other techniques for forming
the container and or its components may be used as is known to
those of skill in the art. The container may also comprise a
variety of coatings or treatments such as a hydrophilic
coating.
[0072] The dimensions of the container should be sufficient such
that the containers can fluidly connect with various conventional
syringes and delivery catheters. However, the dimensions may vary
such that the container may be adapted to connect with other types
of liquid sources (e.g., a gas line) and delivery devices.
[0073] FIG. 5b illustrates another container (530). The container
(530) shown in FIG. 5b differs from that shown in FIG. 5a in that
the chamber includes a ramped portion 532. Ramp portion (532)
focuses the vaso-occluding particles (534) at the outlet port. This
generally serves to "meter" the particles as they are ejected from
the container, preventing clumping.
[0074] FIG. 5c illustrates another container (534) also having a
ramped portion (536). However, in this variation, a fluid relief
lumen (538) is provided along the ramped portion. A plurality of
relief openings (539) fluidly connect the chamber to the fluid
relief lumen. The relief openings are sized to permit only liquid
(not the vaso-occluding particles) into the fluid relief lumen.
[0075] Accordingly, liquid may be driven through the container and
into the delivery catheter regardless of the degree of particle
clogging at the container outlet. In this variation, therefore,
vaso-occluding particles in the catheter may be pushed through the
catheter by fluid pressure regardless of the degree of particle
clogging in the container.
[0076] FIG. 5d illustrates another container (540) having a first
chamber (542) for holding a plurality of vaso-occluding materials
(544) and a passageway (546). The diameter of the passageway (546)
may be adjusted to provide an optimal particle throughput. In this
variation the passageway has a diameter equal to that of a particle
(548). The narrow passageway (546) is to help organize the
particles as they enter a delivery catheter (not shown).
[0077] FIG. 5e illustrates yet another container (554). The
container shown in FIG. 5e differs from that shown in FIG. 5d in
that the container (554) of FIG. 5e includes a spiral passageway
(556). Like the container shown in FIG. 5d, the container shown in
FIG. 5e provides for organized particle transport and ejection.
[0078] FIG. 5f illustrates yet another container. The container
shown in FIG. 5f includes a mixing member (560) for displacing the
vaso-occluding materials. Mixing the particles prevents the
particles from clumping. Mixing member (560) includes a handle
portion that is outside the container and a working portion that is
inside the chamber. The mixing member may also include fingers
(562). The fingers (562) contact and move the vaso-occluding
materials when the mixing member is moved (or rotated). The mixing
member may be movable linearly and or angularly. Accordingly, the
variation shown in FIG. 5f provides a container which actively
prevents clumping of vaso-occluding particles near the outlet.
[0079] FIG. 5g illustrates a container having a constant diameter
passageway (572) and a tapered distal end (570). When the container
is connected with a delivery catheter, the tapered distal end (570)
extends into the proximal end of the catheter. This extends the
constant diameter passageway into the delivery catheter and
alleviates problematic flow effects arising from the entrance of
the delivery catheter.
[0080] FIG. 5h illustrates another container having a one-way valve
(578). The valve (578) may be a duckbill valve made of an
elastomeric material which remains closed in its relaxed state.
Upon applying fluid pressure from the fluid inlet port (580), the
valve opens allowing fluid to pass. However, fluid and particles
cannot pass the other direction. The valve may be positioned at the
outlet end or at another location of the container. Also, multiple
valves may be used to provide particular flow control schemes.
[0081] The vaso-occluding particles may be hydrated with a
hydration liquid and the hydration liquid may be pushed through,
for example, a screen or membrane or the like. A second liquid may
be supplied to the container to purge the first liquid and to drive
the vaso-occluding particles to a desired site. The second liquid
may be a therapeutic liquid. Examples of therapeutic liquids
include but are not limited to analgesics, anesthetics,
antibiotics, thrombotic agents, chemotherapeutic drugs, and
thrombolytic agents. A particular example is doxorubicin, which is
used to treat tumors. Also, a contrast agent for visualization can
be used. Accordingly, the target site can be simultaneously treated
with embolizing particles and a therapeutic liquid.
[0082] FIG. 5i illustrates a variation using a movable screen
(582). The screen has openings, which allow liquid, but not
particles, to pass. The screen (582) may be pie shaped as shown in
FIG. 5l and it may have at least one open region (583) (or open
"slice"). Also, the open region may include apertures so long as at
least one of the apertures is larger than the vaso-occluding
particles. When this particle-passing region (583) is aligned with
an opening on a screen support such as support (585),
vaso-occluding particles may pass therethrough. When the regions
are not aligned, only fluid (and not the particles) may pass.
[0083] FIG. 5j illustrates a container having a fixed screen (584)
and a cap (588) covering the outlet (586). The screen has openings
that permit fluid, but not particles, to pass. The container shown
in FIGS. 5i-5j may be used to hydrate vaso-occluding particles and
provide a way to replace the hydrating fluid with a second, perhaps
therapeutic fluid.
[0084] FIG. 5k illustrates another container (590). In this
example, the container (590) includes a spiral passageway (592)
leading to a ramped chamber (594). The ramped chamber further leads
to a straight passageway (596).
[0085] The spiral passageway (592) includes at least one particle
aperture (598) through which vaso-occluding particles moving along
the passageway may pass. Thus, some particles fall through the
apertures (598) and other particles continue down the spiral
passageway (592). The particles that fall through the apertures
bypass one or more turns in the spiral passageway and directly
enter the ramped section (594). The ramped chamber shown in this
variation is tapered and focuses the particles into a straight
passageway (596) which accepts only one particle at a time.
Accordingly, the container (590) focuses vaso-occluding particles
into an attached delivery catheter (not shown).
[0086] FIG. 5m shows a container (1500) having a helical passageway
(1502) extending from a fluid inlet (1504) to a fluid outlet
(1506). The helical passageway of FIG. 5m, however, does not
include apertures along its path so that particles (and/or
filaments) stay in line along the helical path before reaching the
fluid outlet. In still another variation, as shown in FIG. 5n, a
container (1510) has a helical path (1512) extending from an inlet
(1514) to a ramped section (1516) which focuses or funnels the
occluding materials to a fluid outlet (1518). Accordingly,
containers described herein may have helical passageways which do
include apertures along their paths and helical passageways which
do not include apertures along their paths. The helical passageways
may extend to fluid outlets or the passageways may lead to another
focusing chamber such as a ramped section, which focuses the
occluding materials to a fluid outlet.
Containers for Holding Vaso-Occluding Filaments
[0087] The containers described herein may also hold and deliver
vaso-occluding filaments, such as those described in the co-pending
applications incorporated herein by reference above, the full
disclosures of which are incorporated herein by reference.
[0088] FIG. 6a illustrates a particular container (600) suitable
for delivering a filament (602). Similar to the above described
containers, the container (600) shown in FIG. 6a includes an inlet
(604) for receiving liquids, a passageway or chamber (606) for
holding the filament and liquids (607), and an outlet (608) for
ejecting the filament and or liquid. The inlet end and outlet end
can be designed to fluidly connect with a fluid source (e.g., a
syringe) and a delivery catheter respectively. In operation, the
filament is hydrated and ejected from the outlet (608) into, for
example, a delivery catheter. The chamber shown in FIG. 6a may be
cylindrical and substantially larger in diameter than the filament
(602). However, the invention is not so limited and other shapes of
chambers are contemplated.
[0089] FIG. 6b illustrates another container (610) having a spiral
passageway (612). The spiral passageway (612) is very space
efficient and holds very long filaments in short containers. A
displacement member or wire may be provided to push the filament
through the passageway. The displacement wire may be a flexible
metal or alloy. The displacement wire may be made of, for example,
NITINOL. Such a displacement member may include markings along its
length. The marks may be equally spaced to provide an idea or
measure of the length of filament ejected from the distal end of
the catheter. Alternatively, syringes connected at distal end (611)
of the container (610) may be used to draw in and eject individual
or multiple filaments.
[0090] FIG. 6c shows yet another container (620) having a set of
ganged passageways (622) for holding and delivering multiple
filaments (624) in parallel. The container (620) shown in FIG. 6c
also includes a ramped portion (626) to focus the filaments towards
the delivery end. FIG. 6d shows a cross sectional view of the
container along 6d-6d. This container provides for multiplexed
filament delivery.
[0091] FIGS. 6e-6f illustrate another container (630) for holding
filaments (632). The container (630) shown in FIGS. 6e and 6f is
shaped like a disk. The container (630) includes a passageway (634)
for holding and delivering a filament (632) from an inlet (636) to
an outlet port (638). The passageway may be a spiral, serpentine,
or other curved shape to connect the inlet (636) to the outlet
(638). Also, it is to be understood that the shape of the container
may vary greatly and include, for example, cylindrical, disk,
rectangular, oval, turnip, and other shapes.
[0092] FIGS. 6g and 6h illustrate another container (640) similar
in function to those shown in FIGS. 6e-6f. These figures depict a
centerline of inlet (642) and the centerline of outlet (644)
separated by a distance (D).
[0093] FIG. 6i illustrates yet another container (650) including a
membrane (652) between a base (654) and a cover (656). The base,
membrane and cover are detachably connected such that pre-selected
membranes may be added or removed for various applications. Also,
the components should be fluidly sealed to prevent leaks.
[0094] One application for container (650) is filament hydration. A
hydrating liquid is supplied to the passageway (662) via inlet
(658), hydrating the contents therein. The liquid may then be
driven through membrane (652) and ejected from outlet (660). The
membrane includes openings that prevent the filament from passing
therethrough yet allow the hydrating liquid to pass therethrough. A
variety of membranes and filters may be used to selectively allow
certain substances to pass. Once the filament is hydrated, the
membrane is removed and the container is connected with a delivery
tool to deliver the filament to a target site.
[0095] FIGS. 6j-6k illustrate yet another container (670) having a
conical end section (674). The conical end section (674) has a
fluid outlet port allowing liquids and vaso-occluding materials to
flow therethrough. The conical end section (674) is adapted to
extend into (and mate) with the proximal end of a delivery
catheter.
[0096] The conical distal end section (674) also includes rinse
ports (676) as shown of FIG. 6k. The rinse ports (676) are sized to
prevent vaso-occluding materials such as filaments and particles
from flowing therethrough but allow liquid to pass
therethrough.
[0097] An application for container (670) is filament hydration and
delivery. A hydrating liquid is injected into the container. The
hydrating liquid hydrates the filament, and exits through the rinse
ports (676). The vaso-occluding materials, however, are prevented
from passing through the rinse ports due to their size and are
prevented from passing through the outlet port (680) due to the cap
(678). Once the filaments are hydrated, a second liquid can be
supplied to the container purging the hydrating liquid from the
system. The cap may then be removed and the container may be
connected with a catheter assembly.
[0098] The distal end section (674) may be designed such that the
rinse ports (676) are covered by the delivery catheter entrance
(not shown) when the catheter is connected with the container. In
particular, the conical section (674) extends into the catheter hub
such that the rinse ports (676) are covered. Accordingly,
vaso-occluding materials and or liquids are forced to pass through
the fluid outlet port (680) and into the delivery catheter.
Rotatable Multi-Passageway Container
[0099] FIGS. 7a-7c show several views of a delivery catheter
assembly having a rotatable multi-passageway container (710). In
this variation, a catheter assembly (700) includes a container
(710) having a plurality of passageways (712) for holding filaments
(714), a syringe (720) for supplying fluid to the container to
hydrate and drive the filaments, and a delivery catheter (730) for
delivering the filaments to a target site.
[0100] The container shown in FIG. 7a includes a revolving barrel
(740). The barrel revolves about a central axis. The revolving
barrel includes a plurality of passageways (714). The passageways
are circumferentially positioned along a circle. See, for example,
FIG. 7b. Each passageway (714) is configured to hold vaso-occluding
filament. The passageways may take various shapes and be, for
example, straight or curved.
[0101] The revolving barrel also has a fluid inlet port that is
fluidly connected with a syringe. The barrel further has a distal
end and the passageways extend to the distal end, defining an equal
number of filament exit ports. There are four passageways shown in
this figure but the invention is not so limited and the barrel may
have more or less passageways.
[0102] The container also includes a body (750), which fluidly
connects one of the passageways (714) with the proximal end of the
delivery catheter (730). The body includes one channel (752) which
can align (or register) with a selected passageway of the plurality
of passageways (714). See also FIG. 7c. Once a passageway is
aligned with the channel a complete fluid pathway is formed from
the syringe to the delivery catheter. Accordingly, a selected
filament may be ejected from the container into the delivery
catheter.
[0103] It is to be understood that while the above described
variation shows the barrel and syringe being rotatable, the
invention is not so limited. Other members may be rotated to
achieve a complete fluid pathway for filament delivery. Also, the
container may be "closed" by adjusting the barrel such that no
passageways are aligned with the channel, fluidly sealing each
passageway.
[0104] FIG. 7d shows another catheter assembly (760) having a
movable multi-chamber container (770). This variation is different
than the above barrel shaped variation in that it is card-shaped.
Also, the container moves in a plane such as the XY plane. The
passageways from the movable device are aligned with a channel of
the body component (780) to create a fluid path connecting the
syringe to the delivery catheter. Accordingly, filaments may be
pushed through the container and to the target site.
Filament Length Control
[0105] When delivering vaso-occluding filaments to a target site,
it is sometimes desirable to break or sever the filament. For
example, in selecting a specific size filament for filling an
aneurysm it is desirable to break the filament at a certain
location along the length of the filament. Various techniques for
breaking the filaments are described herein.
[0106] One technique for severing a filament is shown in FIGS. 8a
and 8b. These figures depict inflating a balloon member (810) to
pinch a filament (812) between the balloon and the inner wall (816)
of a delivery catheter. As the balloon member expands it continues
to pinch the filament until the filament severs.
[0107] Another "pinching" technique is shown in FIG. 8c. In FIG.
8c, an enlarged member (820) is provided. When the enlarged member
(820) is moved proximally, it pinches the filament (822) against
the delivery catheter wall, breaking the filament. The enlarged
member may have a ball shape. The enlarged member may also be, for
example, a knot.
[0108] Another technique for breaking a length of filament is shown
in FIG. 8d. In particular, a noose (832) surrounds the filament
(834) at a selected location. The noose (832) is tightened by
pulling the member (830) thereby breaking the filament. An
exemplary snare device is shown in U.S. Pat. No. 6,312,421 to
Boock.
[0109] Still other techniques for breaking the filament include
providing the filament with a detachable joint. The detachable
joint may be activatable or dissolvable upon receiving various
stimuli such as, for example, blood, pH, electricity, heat, and
other stimuli. The detachable region may be scored or otherwise
designed to incorporate a localized weak region in the filament.
The filament may be stretched across a localized region and the
filament will break at the weakened point.
[0110] It is to be understood that the filament may be broken or
severed at a point distal to the catheter end, within the catheter,
and perhaps within the container.
[0111] The filament may also contain discrete sections along its
length to provide information to the doctor or physician. This
information or feedback may be provided by incorporating bulges,
knots, radio-opaque markers, or other types of discrete sections
(or features) along the length of the filament. The discrete
sections may be separated by segments of known length. A sensor may
be positioned on the distal end of the delivery catheter to monitor
the number of segments exiting the delivery catheter. Given the
length of each segment, and the number of segments ejected, the
total length of filament dispensed from the catheter may be
determined. Once a desirable length of filament has been ejected,
the filament is cut. The bulges, knots, etc. may also be used to
trigger a mechanism that severs the filament.
Applications
[0112] As indicated above, containers may hold and introduce
vaso-occluding materials to a delivery catheter. The containers may
be shipped or delivered to a doctor in a kit form that is ready to
be used. Such kits may be designed to include both or either
hydrated or unhydrated particles and filaments. Shipping the
filaments in a ready-to-use kit minimizes compression of filaments.
For example, shipping the filament in a ready-to-use hydrated state
minimizes the chance that a filament will break during shipping.
Some types of filaments are brittle in their unhydrated state.
[0113] Also, the vaso-occluding materials may be packed in
particular configurations to optimize packing (e.g., increase
packing density). Particles and filaments may be formed in certain
shapes (having certain cross sections) such as cubic, hexagonal and
triangular so that the particles or filaments interlock and
minimize dead space. Spherical and cylindrical shapes may have more
dead space when the particles are packed together.
[0114] These devices may be used in a wide variety of ways. For
example, the vaso-occluding materials may be designed for
implantation into the vasculature of a patient. The implantation
site may be any site of abnormal blood flow in the patient such as
the brain. The abnormal blood flow may be caused by an aneurysm, a
ruptured blood vessel, an AVM, a fistula, or a benign or malignant
tumor (e.g., cancer or fibroid or the like). Otherwise untreatable
tumors are particularly contemplated for treatment by implantation
of the vaso-occlusive devices of the invention, as are uterine
fibroids and the like. Additionally, the vaso-occlusive devices may
be designed for implantation into vessels, ducts and cavities found
in the body which are not part of the blood vascular system.
[0115] The containers and kits also provide for conveniently
hydrating and dispensing particles in a single step. That is, in a
single step liquids can be supplied to the container to hydrate the
vaso-occluding materials and push them into the delivery catheter.
Consequently, there is less likelihood of contamination.
[0116] Additionally, various therapeutic liquids may be used with
the present invention. The therapeutic liquids are added to the
container, purging the first liquid if necessary. Also, the present
invention provides for breaking the filaments at certain locations
along their lengths. The length of filament ejected may thusly be
controlled. Also, graduated lengths of containers may be provided.
Each container can include a length of filament corresponding to
the size of container.
[0117] Referring to FIGS. 9 and 10, an exemplary system (900) for
holding and delivering vaso-occluding elements to target body
locations, typically in the vasculature, will be described. While
the system comprises up to four components, a container (902)
comprising a delivery tube (904) is the principal novel component
of the system. The system (900) may also include a syringe (906) or
other conventional device for delivering a hydrating liquid or
other fluid under pressure, and implanted catheter (908) comprising
a catheter body (910) and a proximal catheter hub (912) (shown in
section), and a hemostasis valve (914). The delivery tube (904) has
the dimensions generally set forth above, and is typically composed
of a polymer, such as polyethylene, although in certain
circumstances it could be formed from a metal, glass, or other
material. Delivery tube (904) has an inlet end (920) and an outlet
end (922), with a Luer or other inlet coupling (924) attached to
the inlet end. The outlet end (922) is typically configured as a
straight section of the tube (904), although it would be possible
to provide connection interfaces or otherwise configure the
straight end, as described below in connection with FIGS. 11A and
11B.
[0118] Because of its length, it is usually desirable to configure
or structure the delivery tube (904) so that it occupies a
considerably lesser length in the container (902). As illustrated
in FIG. 9, the delivery tube (904) may be helically coiled over a
portion of its length, thus shortening the overall effective length
of the container. For example, delivery tubes having lengths in the
range from 5 cm to 10 meters, usually from 5 cm to 5 meters, may
have coils with a diameter in the range from 5 mm to 20 mm, with
from 2 turns to 1000 turns, usually from 5 to 100 turns. Other
configurations for shortening the effective length of the delivery
tube (904) include planar coils (FIG. 13), planar serpentine
configurations (FIG. 14), and the like. As shown in FIG. 9, the
coiled section (930) of the delivery tube (904) is mounted over a
barrel (932) and/or within an outer tube (934).
[0119] The hydratable elements to be delivered by system (900) will
be contained in a lumen of delivery tube (904). The hydratable
elements may be stored in a hydrated, partially hydrated, or
non-hydrated form, but will in at least most cases be fully
hydrated before delivery. The syringe (906) may be utilized for
delivering the hydrated vaso-occluding particles from the delivery
tube (904) of container (902). In particular, the syringe may be
attached to the Luer fitting (924), as illustrated in FIG. 10. The
syringe will be filled with a hydrating medium or other suitable
liquid for delivery through the delivery tube (904), thus
permitting delivery of the hydrated elements by pressurized
introduction of the hydrating medium or other liquid.
[0120] Referring now to FIGS. 11A and 11B, the outlet end (922) of
delivery tube (904) is received in a passageway (940) of the
catheter hub (912). Preferably, a pressure-type seal (i.e., a seal
which prevents leakage under the expected infusion pressures) will
be formed between the outlet end (922) and the interior wall of the
hub passage (940). For example, a spherical seal (942) may be
formed at the distal tip of the delivery tube (904), where the
spherical seal engages and seals against a tapered region of the
passageway in the catheter hub. Alternatively, the distal end of
the delivery tube (904) may itself be tapered so that it seats in
and seals against the passageway (940), as shown in FIG. 11B.
Optionally, as shown in FIG. 11C, the outlet end (922) may be held
in a spring (923) which allows the spherical seal (942) to
compressibly engage the interior (940) of the hub (912). The hub
(912) will be directly connected to a Luer or other fitting (925)
in the container (902). It would also be possible to substitute a
screw mechanism for the spring, although that option is not
illustrated. In either case, any extension or compression of the
tube (904) can be accommodated by compression or extension of the
helical portion of the tube, i.e., the helix will simply act like a
spring. In some cases, by properly controlling the elasticity of
the tube material, the helical section of the delivery tube (904)
could provide the necessary spring force and no separate spring
(923) would be necessary.
[0121] While it is generally preferred to form a seal within the
catheter hub, a separate hemostatic valve (914) may be provided for
sealing against the exterior of the delivery tube (904) at a
location immediately proximal to the hub (940), as illustrated in
FIG. 10. A hemostatic seal (914) includes Luer fittings at each end
so that it may be positioned between the proximal end of hub (912)
and distal end of container (902), as illustrated in FIG. 10. By
sealing over the exterior of the straight portion of delivery tube
(904), a relatively small, enclosed volume is created between the
hemostasis valve and the proximal end of catheter body (910). While
this volume will receive some flow and pressure from the hydrating
medium being introduced through the lumen of the delivery tube
(904), the pressure will quickly equalize and the passage of
vaso-occluding element(s) and hydrating medium into the lumen of
the catheter body (910) will quickly be accomplished.
[0122] The container system (900) may be sterilely packaged and
distributed either with or without pre-loaded vaso-occluding
element(s). When pre-loaded, the vaso-occluding elements may be
hydrated, partially hydrated, or non-hydrated, and at least the
container (902) holding the vaso-occluding element(s) will be
sterilely packaged. Optionally, other system components may be
combined in the same or a separate sterile package.
[0123] Alternatively, the container (902) and/or other system
components may be sterilely packaged and distributed separately
from the vaso-occluding element(s). In that case, it will be
necessary to load the vaso-occluding element(s) into the delivery
tube (904) prior to use. As illustrated in FIGS. 12A and 12B, a
filament F may be loaded into the delivery tube by first hydrating
the filament in a suitable hydrating medium H in a bowl, dish, or
the like. After the filament has been hydrated, the outlet end
(922) of the delivery tube (904) may be immersed in the hydrating
medium H and located next to one end of a filament F. By then
pulling on the plunger in syringe (906), hydrating medium and the
filament is drawn into the delivery tube, as shown in FIG. 12B.
Usually, the delivery tube (904) will be primed with hydrating
medium H prior to drawing in the filament F.
[0124] While the container (902) having a helical delivery tube
(904) is illustrated in FIGS. 9 and 10, other delivery tube
configurations are also possible. As shown in FIG. 13, a delivery
tube (980) may be configured as a spiral on one side of a card
(982). On the center of the card, the tube may be drawn through to
the other side and brought out so that an inlet (984) is available
for connection to a syringe, typically with a Luer (986). The
delivery or outlet end (988) of tube (980) may be provided with any
of the configurations discussed with prior embodiments.
[0125] As a further alternative, a delivery tube (990) may be
formed in a serpentine pattern on a support card (992). An outlet
or delivery end (994) can extend from one side of the card, while
an inlet end (996) having a Luer fitting (998) extends from the
other side of the card. In general, both delivery tubes (990) and
(980) can be used in place of container (902) and delivery tube
(904) in the container system of FIGS. 10 and 11.
[0126] Other features that may be incorporated into the apparatus
of the present invention include mixing mechanisms in the delivery
chamber or delivery tube, e.g., fluid flow or a mixing member
coupled to the syringe plunger which is advanced with depression of
the plunger to mix the elements, particularly particles, to assist
in advancement from the delivery chamber to the catheter. It may
also be useful to graduate or otherwise mark the delivery tube to
indicate filament length, particularly where the marking instructs
the user where to cut the tube to ensure compatibility with the
catheter hub.
[0127] All publications, patent applications, patents, and other
references mentioned herein are incorporated by reference in their
entirety. To the extent there is a conflict in a meaning of a term,
or otherwise, the present application will control.
[0128] Although the foregoing invention has been described in some
detail by way of illustration and example for purposes of clarity
of understanding, it will be readily apparent to those of ordinary
skill in the art in light of the teachings of this invention that
certain changes and modifications may be made thereto without
departing from the spirit or scope of the appended claims.
* * * * *