U.S. patent application number 14/448686 was filed with the patent office on 2014-11-20 for endoluminal drug delivery devices and methods.
The applicant listed for this patent is ETD-VDP LLC. Invention is credited to Jose Almeida, Julian Javier, Edward Mackay, Jihad Mustapha.
Application Number | 20140343482 14/448686 |
Document ID | / |
Family ID | 47354261 |
Filed Date | 2014-11-20 |
United States Patent
Application |
20140343482 |
Kind Code |
A1 |
Mackay; Edward ; et
al. |
November 20, 2014 |
ENDOLUMINAL DRUG DELIVERY DEVICES AND METHODS
Abstract
A device and method for delivering a drug from inside a body
lumen to tissue surrounding the body lumen. An endoluminal drug
delivery device includes a dual-lumen catheter for housing a
guidewire and a needle connectable to a drug source. The guidewire
exits the catheter through an opening at the distal end, and the
needle exits the catheter through an exit port in the outer wall of
the catheter. A distal portion of the catheter has a single lumen
and includes a taper, allowing the distal tip to act as a dilator.
The device optionally includes a catheter lumen splitter and/or a
handpiece assembly. A method of delivering fluid to tissue
surrounding a body lumen includes inserting a guidewire into the
body lumen, tracking the device over the guidewire, deploying the
needle through the exit port to the tissue, delivering fluid, and
retracting the needle into the catheter.
Inventors: |
Mackay; Edward; (Largo,
FL) ; Almeida; Jose; (Miami, FL) ; Javier;
Julian; (Naples, FL) ; Mustapha; Jihad; (Ada,
MI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ETD-VDP LLC |
Miami |
FL |
US |
|
|
Family ID: |
47354261 |
Appl. No.: |
14/448686 |
Filed: |
July 31, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13162426 |
Jun 16, 2011 |
8852165 |
|
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14448686 |
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Current U.S.
Class: |
604/21 ; 604/151;
604/164.03; 604/506 |
Current CPC
Class: |
A61M 2025/0092 20130101;
A61M 2025/0183 20130101; A61B 18/12 20130101; A61M 25/0097
20130101; A61M 25/0084 20130101; A61M 2025/0037 20130101; A61M
25/0009 20130101; A61M 25/003 20130101; A61M 25/0074 20130101; A61B
18/20 20130101; A61M 5/142 20130101; A61M 29/00 20130101 |
Class at
Publication: |
604/21 ; 604/506;
604/164.03; 604/151 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61B 18/12 20060101 A61B018/12; A61B 18/20 20060101
A61B018/20; A61M 5/142 20060101 A61M005/142 |
Claims
1. A method of delivering a fluid to tissue surrounding a body
lumen having a wall, the method comprising: percutaneously
inserting a guidewire into the body lumen through the wall;
inserting a distal end of an endoluminal drug delivery device into
the body lumen by tracking a first lumen of the device over the
guidewire, the device comprising: a catheter having a proximal end
and a distal end; the first lumen extending from the proximal end
to the distal end; a second lumen extending between the proximal
end and an exit port, a section of the catheter distal to the exit
port being self-dilating during tracking; and a needle configured
to bias away from the second lumen and out of the exit port when
the needle is longitudinally distally advanced; when the exit port
is in a first position advancing the needle out of the second lumen
through the exit port; advancing the needle through the wall to the
tissue; delivering the fluid to the tissue through the needle; and
retracting the needle into the catheter.
2. The method of claim 1, further comprising: tracking the device
over the guidewire within the body lumen; when the exit port is in
a second position advancing the needle out of the second lumen
through the exit port; advancing the needle through the wall to the
tissue; delivering the fluid to the tissue through the needle; and
retracting the needle into the catheter.
3. The method of claim 1, wherein the fluid comprises
tumescent.
4. The method of claim 1, wherein the body lumen is an insufficient
vein.
5. The method of claim 1, further comprising treating the body
lumen with laser or radio frequency ablation.
6. An endoluminal drug delivery device comprising: a flexible
catheter having a proximal end and a distal end; a first lumen
extending from the proximal end to the distal end and configured to
house a guidewire; a second lumen extending between the proximal
end and an exit port, a section of the catheter distal to the exit
port being self-dilating; and a needle configured to bias out of
the exit port and away from the second lumen when the needle is
longitudinally distally advanced, the needle including a needle
lumen configured to be in fluid communication with a drug delivery
system.
7. The device of claim 6, wherein the exit port is proximate to the
distal end.
8. The device of claim 6, wherein a distal portion of the catheter
comprises a taper at least partially defined by a decrease in an
outer diameter of the catheter from a proximal end of the taper to
the distal end of the catheter.
9. The device of claim 6, wherein the catheter comprises a
deflection surface.
10. The device of claim 6, further comprising a lumen splitter
coupled to the catheter proximate to the proximal end of the
catheter.
11. The device of claim 6, further comprising a handpiece assembly
coupled to a proximal end of the device, the handpiece assembly
comprising a button coupled to the needle, wherein actuation of the
button causes relative longitudinal movement between the needle and
the catheter.
12. The device of claim 11, wherein longitudinal movement of the
button causes 1:1 longitudinal movement of the needle in the second
lumen.
13. The device of claim 6, wherein the needle is rotationally fixed
relative to the catheter.
14. The device of claim 6, wherein the catheter comprises
polyethylene.
15. The device of claim 6, wherein the catheter has a length
between about 45 cm and about 55 cm.
16. The device of claim 6, wherein a portion of the second lumen
proximate to the exit port comprises a rigid lining.
17. The device of claim 6, wherein the needle comprises a shape
memory material.
18. The device of claim 17, wherein the needle comprises
nitinol.
19. The device of claim 6, wherein a distal portion of the needle
is curved when at least partially outside the second lumen.
20. The device of claim 6, wherein the needle comprises a beveled
distal tip.
21. An endoluminal drug delivery system comprising: the device of
claim 6; and tubing configured to couple the needle lumen to a drug
delivery system.
22. The system of claim 21, wherein the drug delivery system
comprises a dual check valve configured to be connected to a fluid
source and a syringe.
23. The system of claim 21, wherein the drug delivery system
comprises a pump configured to be connected to a fluid source.
24. A method of manufacturing an endoluminal drug delivery device,
the method comprising: inserting a needle into a second lumen of a
catheter comprising: a first lumen extending from a proximal end to
a distal end and configured to house a guidewire; and the second
lumen extending between the proximal end and an exit port, a
section of the catheter distal to the exit port being
self-dilating; the needle configured to bias out of the exit port
and away from the second lumen when the needle is longitudinally
distally advanced, the needle including a needle lumen configured
to be in fluid communication with a drug delivery system.
25. The method of claim 24, further comprising inserting a guide
tube into the second lumen, the guide tube surrounding the
needle.
26. The method of claim 24, further comprising coupling a lumen
splitter to the catheter proximate to the proximal end of the
catheter.
27. The method of claim 24, further comprising connecting a
handpiece assembly to a proximal end of the device.
28. The method of claim 27, wherein the handpiece assembly
comprises a driver and wherein connecting the handpiece assembly to
the proximal end of the device comprises connecting a proximal end
of the needle to a distal end of the driver.
29. The method of claim 24, further comprising forming a distal end
of the needle into a beveled tip.
30. The method of claim 24, further comprising shape setting a
distal portion of the needle into a curved configuration.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/162,426, filed Jun. 16, 2011, which is
incorporated by reference herein in its entirety.
BACKGROUND
[0002] 2. Field
[0003] The present application generally relates to devices and
methods for delivering medicinal substances to an area surrounding
a vein.
[0004] 2. Description of the Related Art
[0005] Normally, valves in veins keep blood moving toward the heart
and prevent backflow. In patients with varicose veins, the valves
do not function properly, so blood flows back toward the patient's
extremities and pools in the veins. This can lead to skin necrosis.
Laser or RF ablation treatment creates hypercoagulability to close
the abnormal vein, which is subsequently absorbed by the body. The
current commonly-used method of delivering numbing medication to
the treatment area prior to the ablation procedure requires
multiple injections in the patient's thigh, each through the skin.
Disadvantages of this method can include pain for the patient and
inefficiency.
SUMMARY
[0006] The devices and methods described herein can use only a
single puncture through the patient's skin to deliver multiple
injections of a drug from inside a body lumen, such as a vein, to
the tissue surrounding the body lumen. The endoluminal drug
delivery device includes a flexible catheter with two lumens--a
first lumen for a guidewire and a second lumen for a needle. The
guidewire exits the catheter through an opening at the distal end,
and the needle exits the catheter through an exit port in the
catheter wall. The first lumen and guidewire can span the length of
the catheter or only a distal portion of the catheter. The second
lumen ends at the exit port, so the section of the catheter distal
to the exit port has only one lumen and serves as a dilator. The
catheter can have multiple exit ports along its length. A distal
portion of the catheter can be tapered, and the exit port can be on
the straight portion of the catheter or on the tapered portion. The
second lumen houses a needle including a shape-memory material,
such as nitinol, that is shape-set to have a curved distal portion.
The needle straightens when inside the catheter, but when pushed
forward in the catheter, the needle is configured to bias away from
the second lumen and out of the exit port and assumes its curved
shape. The catheter can split into two single-lumen portions at the
proximal end of the catheter, and the device can have an optional
lumen splitter to provide strength at the joint where the catheter
splits. The device can also have an optional handpiece assembly
with a button used to move the needle. The needle can be connected
to a drug delivery system having a drug source. To use the device,
the guidewire is inserted into a body lumen, such as a vein,
through the patient's skin and the device is tracked over the
guidewire by using the section of the catheter distal to the needle
exit port as a dilator. Once the catheter is in position, the
needle is pushed forward so that it exits the catheter through the
exit port, pierces the body lumen wall, and enters the tissue
surrounding the body lumen. The drug is delivered to the tissue
from the drug source and delivery system, and then the needle is
retracted back into the catheter. The device can then be further
tracked over the guidewire to a different position, and the process
can be repeated as desired.
[0007] In some embodiments, an endoluminal drug delivery device
comprises a flexible catheter. The flexible catheter has a proximal
end and a distal end. The device further comprises a first lumen
extending from the proximal end to the distal end, a second lumen
extending between the proximal end and an exit port, and a needle.
The first lumen is adapted to house a guidewire. A section of the
catheter distal to the exit port is self-dilating. The needle is
configured to bias out of the exit port and away from the second
lumen when the needle is longitudinally distally advanced. The
needle includes a needle lumen configured to be in fluid
communication with a drug delivery system.
[0008] In some embodiments, a method of delivering a fluid to
tissue surrounding a body lumen having a wall comprises
percutaneously inserting a guidewire into the body lumen through
the wall and inserting a distal end of an endoluminal drug delivery
device into the body lumen by tracking a first lumen of the device
over the guidewire. The device includes a catheter having a
proximal and a distal end. The first lumen extends from the
proximal end to the distal end. The device further includes a
second lumen extending between the proximal end and an exit port
and a needle. A section of the catheter distal to the exit port is
self-dilating during tracking The needle is configured to bias away
from the second lumen and out of the exit port when the needle is
longitudinally distally advanced. When the exit port is in a first
position, the needle is advanced out of the second lumen through
the exit port. The method further comprises advancing the needle
through the wall to the tissue, delivering fluid to the tissue
through the needle, and retracting the needle into the
catheter.
[0009] In some embodiments, a method of manufacturing an
endoluminal drug delivery device comprises inserting a needle into
a second lumen of a catheter. The catheter includes a first lumen
extending from a proximal end to a distal end and is configured to
house a guidewire and the second lumen extending between the
proximal end and an exit port. A section of the catheter distal to
the exit port is self-dilating. The needle is configured to bias
out of the exit port and away from the second lumen when the needle
is longitudinally distally advanced. The needle includes a needle
lumen configured to be in fluid communication with a drug delivery
system.
[0010] For purposes of summarizing the disclosure and the
advantages achieved over the prior art, certain objects and
advantages are described herein. Of course, it is to be understood
that not necessarily all such objects or advantages need to be
achieved in accordance with any particular embodiment. Thus, for
example, those skilled in the art will recognize that the
disclosure may be embodied or carried out in a manner that achieves
or optimizes one advantage or group of advantages as taught or
suggested herein without necessarily achieving other objects or
advantages as may be taught or suggested herein.
[0011] All of these embodiments are intended to be within the scope
of the disclosure herein. These and other embodiments will become
readily apparent to those skilled in the art from the following
detailed description having reference to the attached figures, the
disclosure not being limited to any particular disclosed
embodiment(s).
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] These and other features, aspects, and advantages of the
present disclosure are described with reference to the drawings of
certain embodiments, which are intended to schematically illustrate
certain embodiments and not to limit the invention.
[0013] FIG. 1 is a top and side perspective view of an example
embodiment of an endoluminal drug delivery device;
[0014] FIG. 2 is an example embodiment of a transverse
cross-sectional view of the endoluminal drug delivery device of
FIG. 1 along the line 2-2 in FIG. 1;
[0015] FIG. 3A is a top and side perspective view of an example
embodiment of a distal portion of an endoluminal drug delivery
device;
[0016] FIG. 3B is a longitudinal cross-sectional view of the distal
portion of the endoluminal drug delivery device of FIG. 3A;
[0017] FIG. 3C is a longitudinal cross-sectional view of another
example embodiment of a distal portion of an endoluminal drug
delivery device;
[0018] FIG. 3D is an a longitudinal cross-sectional view of another
example embodiment of a distal portion of an endoluminal drug
delivery device;
[0019] FIG. 4 is a side elevational view of an example embodiment
of the distal portion of a needle;
[0020] FIG. 5A is a longitudinal cross-sectional view of an example
embodiment of a catheter lumen splitter including a portion
enlarged for clarity;
[0021] FIG. 5B is a longitudinal cross-sectional view of another
example embodiment of a catheter lumen splitter including two
portions enlarged for clarity;
[0022] FIG. 6A is an exploded top and side perspective view an
example embodiment of a handpiece assembly;
[0023] FIG. 6B is a longitudinal cross-sectional view of the
assembled handpiece assembly of FIG. 6A;
[0024] FIGS. 7A and 7B show an example embodiment of a drug
delivery system;
[0025] FIG. 8 shows an example embodiment of a method of delivering
a fluid to tissue surrounding a body lumen using an endoluminal
drug delivery device.
DETAILED DESCRIPTION
[0026] Although certain embodiments and examples are described
below, those of skill in the art will appreciate that the
disclosure extends beyond the specifically disclosed embodiments
and/or uses and obvious modifications and equivalents thereof.
Thus, it is intended that the scope of the disclosure herein
disclosed should not be limited by any particular embodiments
described below.
[0027] FIG. 1 illustrates an example embodiment of an endoluminal
drug delivery device 100. FIG. 2 is an example embodiment of a
transverse cross-sectional view of the device 100 of FIG. 1 along
the line 2-2 in FIG. 1. The device 100 comprises a flexible
catheter 102, a first lumen 316, a second lumen 318, and a needle
104. The flexible catheter 102 has a proximal end 115 and a distal
end 116. The first lumen 316 extends from the proximal end 115 to
the distal end 116. The first lumen 316 is configured to house a
guidewire. The second lumen 318 extends between the proximal end
115 and an exit port 106. A section of the catheter 102 distal to
the exit port 106 is self-dilating. The needle 104 is configured to
bias out of the exit port 106 and away from the second lumen 318
when the needle 104 is longitudinally distally advanced. The needle
104 includes a needle lumen 320 configured to be in fluid
communication with a drug delivery system. The guidewire exits the
catheter 102 through an opening 112 at the distal end 116. In some
embodiments, the device 100 comprises an optional catheter lumen
splitter 108 and/or an optional handpiece assembly 120. The device
100 can be used, for example, to deliver a fluid such as a drug to
tissue surrounding a blood vessel as described in greater detail
herein.
[0028] In some embodiments, the catheter 102 has a length between
about 45 cm and about 55 cm. Other lengths are also possible, for
example based on needle size, guidewire size, intended use in
different vasculature, for different patient sizes, etc. In some
embodiments, the cross-sectional diameter of the catheter 102 is
between about 0.090 inches (in.) and about 0.105 in. (approx.
between about 0.23 centimeters (cm) and about 0.27 cm). Other
diameters are also possible, for example based on needle size,
guidewire size, intended use in different vasculature, for
different patient sizes, etc. Other transverse cross-sectional
profiles of the catheter are also possible (e.g., oblong, oval,
egg-shaped, polygonal, etc.). The catheter 102 may comprise a
flexible material so as to be maneuverable within a body lumen as
described herein. For example, in some embodiments, the catheter
102 comprises a polymer (e.g., polyethylene). Other materials are
also possible. The catheter 102 can be manufactured, for example,
by extrusion, injection molding, or another suitable process.
[0029] FIG. 2 illustrates an embodiment in which the two lumens
316, 318 within the catheter 102 are in a parallel configuration.
As described herein, the first lumen 316 is configured to house a
guidewire, and the second lumen 318 is configured to house a needle
104. In some embodiments, the second lumen 318 houses a guide tube
314 between the lumen 318 wall and the needle 104, as shown in FIG.
2 and described in greater detail herein. In some embodiments, the
first lumen 316 and the second lumen 318 have approximately the
same diameter. In some embodiments, the first and second lumens
have different diameters. The diameter of each lumen 316, 318 can
be, for example, between about 0.025 in. and about 0.05 in.
(approx. between about 0.064 cm and about 0.13 cm), between about
0.035 in. and about 0.045 in. (approx. between about 0.089 cm and
about 0.11 cm) (e.g., about 0.039 in. (approx. about 0.099 cm)),
combinations thereof, and the like. In some embodiments, the two
lumens 316, 318 within the catheter 102 are in a different
configuration. For example, the second lumen 318 can be oval or
oblong to allow the needle 104 to flex within the lumen 318. For
another example, the first lumen 316 and the second lumen 318 can
both be oblong. For another example, at least one of the first
lumen 316 and the second lumen 318 can be crescent-shaped. For
still another example, the first lumen 316 and the second lumen 318
can be spaced semicircles. A wide variety of lumen configurations
and shapes are possible, and the shapes of the lumens need not
correspond to the shapes of the elements that the lumens are
configured to contain.
[0030] FIG. 3A illustrates an example embodiment of a distal
portion 200 of the catheter 102 of the device 100. In some
embodiments, the exit port 106 is proximate to the distal end 116
of the catheter 102. For example, the exit port 106 can be between
about 0.6 in. and about 0.7 in. (approx. between about 1.5 cm and
about 1.8 cm) from the distal end 116 of the catheter 102. Other
distances of the exit port 106 from the distal end 116 are also
possible, for example based on dilator length, taper portion angle
if applicable, etc. In some embodiments, the exit port 106 has a
length between about 0.20 in. and about 0.25 in. (approx. between
about 0.51 cm and about 0.64 cm) and a width between about 0.029
in. and about 0.39 in. (approx. between about 0.073 cm and about
0.099 cm). Other exit port 106 dimensions are also possible, for
example based on catheter size, needle size, etc.
[0031] FIG. 3B is a longitudinal cross-sectional view of the distal
portion 200 of the catheter 102 of FIG. 3A. Because the second
lumen 318 of the catheter 102 terminates at the exit port 106
proximal to the distal end 116 of the catheter 102, a single-lumen
section 218 of the catheter 102 distal to the exit port 106 only
contains the first lumen 316. In some embodiments, the single-lumen
section 218 of the catheter 102 has a length from the distal edge
of the exit port 106 to the distal end 116 of the catheter 102 of
between about 0.5 in. and about 0.675 in. (between approx. 1.27 cm
and about 1.72 cm). Other single-lumen section 218 lengths are also
possible, for example based on dilator length, taper portion angle
if applicable, etc. In some embodiments, the distal portion 200 of
the catheter 102 includes a taper toward the distal end 116 (e.g.,
the outer diameter of the catheter 102 decreases from proximal to
distal). In some embodiments, as illustrated in FIGS. 3A and 3B, a
tapered portion 214 of the catheter 102 begins distal to the exit
port 106, so the exit port 106 is on a straight side of the
catheter 102. In some embodiments, the tapered portion 214 begins
proximal to the exit port 106, so the exit port 106 is on the
tapered portion 214 of the catheter 102, for example as illustrated
in FIG. 3D. The single-lumen 316 housing a guidewire makes the
section 218 of the catheter 102 distal to the exit port 106
sufficiently stiff so as to be pushable and allows the catheter 102
to follow the guidewire. The section 218 of the catheter 102 distal
to the exit port 106 effectively serves as a dilator, making the
catheter 102 self-dilating. In some embodiments, tapered features
help guide the catheter 102 as the catheter 102 is tracked over the
guidewire, contributing to the self-dilating nature of the catheter
102. Other shapes may also make the section 218 of the catheter 102
distal to the exit port 106 self-dilating.
[0032] FIG. 3C illustrates an embodiment of a distal portion 202 of
the endoluminal drug delivery device 100 in which the catheter 102
includes a plurality of exit ports 106a, 106b. The needle 104 can
be deployed from any of the exit ports 106a, 106b, depending on the
position of the needle 104 within the catheter 102. In the
embodiment illustrated in FIG. 3C, the exit port 106a is proximate
to the distal end 116 of the catheter 102. In some embodiments, the
distal tip of the needle 104 is initially between the most distal
exit port 106a and the second exit port 106b proximal to the distal
end 116 of the catheter 102. In some embodiments, the needle 104
can be longitudinally distally advanced to exit the most distal
exit port 106a, after which the needle 104 can be longitudinally
proximally advanced proximal to the exit port 106b, and then
longitudinally distally advanced to exit the exit port 106b, and so
on for any number of exit ports 106n (not shown) consecutively from
distal to proximal. In certain such embodiments, the needle 104 can
be used to make a plurality of injections at different longitudinal
positions without movement of the guidewire 102. In some
embodiments, the guidewire 102 is anchored in the vessel during
movement of the needle 104. In some embodiments in which the needle
104 is rotatable within the catheter 102, the needle 104 can be
rotated to bias away from the exit ports 106a, 106b (e.g.,
180.degree. or at least enough to not bias out of the exit ports
106a, 106b) during longitudinal movement when the needle 104 is not
to exit the exit ports 106a, 106b, and can be rotated towards the
exit ports 106a, 106b, and so on to exit port 106n (not shown).
Combinations of the methods described herein are also possible.
Although the exit ports 106a, 106b are illustrated in FIG. 3C as
being circumferentially aligned, other circumferential arrangements
are also possible.
[0033] FIG. 3D schematically illustrates an embodiment of a distal
portion 204 of the endoluminal drug delivery device 100 in which
the first lumen 316 extends from an opening 322 in the outer wall
of the catheter 102 at a position proximal to the distal end 116 of
the catheter 102 (e.g., from about 8 cm proximal to the distal end
116) to the distal end 116 of the catheter 102 in a so-called
"rapid-exchange" configuration. In some embodiments, for example as
illustrated in FIG. 3D, the first lumen 316 and second lumen 318
overlap so that a portion of the catheter 102 comprises both of the
lumens 316, 318. The length of the overlapping portion can vary. In
some embodiments, the first lumen 316 and second lumen 318 do not
overlap within the catheter 102. In certain such embodiments, the
catheter 102 has a smaller cross-sectional profile. The first lumen
316 has an opening 112 at the distal end 116 of the catheter 102. A
guidewire 950 enters the first lumen 316 through the opening 112 at
the distal end 116 of the catheter 102 and exits the catheter 102
through the opening 322 in the catheter 102. The guidewire 950
extends exterior to and alongside the catheter 102 proximal to the
opening 322 in the catheter 102. In some embodiments, for example
as illustrated in FIG. 3D, the opening 322 is along a straight
portion of the catheter 102 proximal to the tapered portion 214. In
some embodiments, the opening 322 is along the tapered portion 214
or the taper-straight junction.
[0034] FIG. 3D also schematically illustrates an embodiment of a
distal portion 204 of the endoluminal drug delivery device 100 in
which the exit port 106 is along the tapered portion 214. The
second lumen 318 and the optional guide tube 314 are straight, and
the needle 104 only curves once the distal portion has exited the
exit port 106. Certain such embodiments may advantageously simplify
manufacturing, for example because the guide tube 314 does not
include a Tuohy-style tip and/or because the second lumen 318 is a
bore. The needle 104 may bias when extended out of the exit port
106 without a deflection surface. In some embodiments, a distal
portion 204 in which the exit port 106 is on the tapered portion
does not include a guide tube, for example because the needle 104
does not distally extend towards a portion of the catheter 102.
[0035] In some embodiments (e.g., as described with respect to
FIGS. 3B and 3C), the tapered portion 214 of the catheter 102
terminates distal to the exit port 106, so the exit port 106 is on
a straight side of the catheter 102 in combination with a
rapid-exchange guidewire configuration. FIG. 3D is schematic, and
the relative dimensions, positions, angles, etc. therein may be
modified to suit a desired configuration. For example, the length
and angle of the tapered portion 214 can vary, the shape of the
first lumen 316 can vary, etc. Other distal sections of the
catheter 102 are also possible, including combinations of
embodiments described herein and otherwise.
[0036] FIG. 4 shows an example embodiment of a distal portion of
the needle 104. In some embodiments, the needle 104 comprises
(e.g., is made of) a shape-memory material, for example, nitinol.
In certain embodiments, the needle 104 is shape-set so that the
distal portion is curved when the needle 104 is not restrained
(e.g., within the second lumen 318 of the catheter 102, within the
guide tube 314, etc.). The distal portion of the needle 104 may be
substantially straight when the needle 104 is confined in the
second lumen 318 of the catheter 102. When unrestrained, the curve
of the distal portion of the needle 104 can have a radius of
curvature between about 0.45 in. and about 0.55 in. (approx.
between about 1.14 cm to about 1.40 cm). Other radii of curvature
and distal portion shapes of the needle 104 are also possible, for
example based on dimensions of the catheter 102, the vasculature,
the patient, etc. The needle 104 can have an inner cross-sectional
diameter between about 0.015 in. and about 0.025 in. (approx.
between about 0.038 cm and about 0.064 cm) and an outer
cross-sectional diameter between about 0.02 in. and about 0.03 in.
(approx. between about 0.05 cm and about 0.08 cm), and can have a
length between about 20 in. and about 30 in. (approx. between about
50 cm and about 76 cm). Other dimensions of the needle 104 are also
possible, for example based on dimensions of the catheter 102, the
vasculature, the patient, etc.
[0037] When the distal end of the needle 104 exits the exit port
106 of the catheter 102, for example as shown in FIG. 3A, the
distal end of the needle 104 self-assumes a curved shape without
requiring influence, for example, from a deflection surface in the
second lumen 318. The needle 104 is thereby configured to bias out
of the exit port 106 and away from the catheter 102 when the needle
104 is longitudinally distally advanced within the second lumen
318. In some embodiments, the catheter 102 comprises a deflection
surface (e.g., a surface of the guide tube 314 or other surface).
In certain such embodiments, the deflection surface comprises a
planar surface, a curved surface, combinations thereof, and the
like. Although the needle 104 is configured to bias out of the exit
port 106 without a deflection surface, a deflection surface may
help to protect interior surfaces of the catheter 102 from the tip
of the needle 104, may help guide a rotatable needle 104 to the
exit port 106, etc. Referring again to FIG. 4, in some embodiments,
in an unrestrained state, the distal tip of the needle 104 is
spaced from a longitudinal axis defined by a straight portion of
the needle 104 on the side of the needle 104 opposite the curve by
a distance x of between about 0.35 in. and about 0.40 in. (approx.
between about 0.89 cm and about 1.02 cm). Other distances x are
also possible, for example depending on the size of the needle 104,
the relative sizes of the vasculature and the catheter 102,
etc.
[0038] The distal tip of the needle 104 is configured to pierce the
vein wall and surrounding tissue. In some embodiments, the distal
tip of the needle 104 has a bevel angle .alpha. between about
10.degree. and about 30.degree., between about 15.degree. and about
25.degree. (e.g., about 20.degree.), combinations thereof, and the
like. Other bevel angles .alpha. are also possible. In some
embodiments, the distal tip of the needle 104 has a conical or
pencil point tip. In certain such embodiments, the distal tip of
the needle 104 has a cone angle between about 10.degree. and about
30.degree., between about 15.degree. and about 25.degree. (e.g.,
about 20.degree.), combinations thereof, and the like. Other cone
angles are also possible. Other configurations of the distal tip of
the needle 104 are also possible. For example, the needle 104 may
include sidewall apertures, apertures configured to spray fluid,
etc. The needle 104 comprises a needle lumen 320 configured to be
in fluid communication with a drug delivery system, and fluid can
be delivered out of the tip of the needle 104.
[0039] In some embodiments, a method of manufacturing the
endoluminal drug delivery device 100 comprises inserting the needle
104 into the second lumen 318 of the catheter 102. In some
embodiments, the method of manufacturing comprises shape setting
(e.g., heat setting) the distal portion of the needle 104 into a
curved or other configuration. In some embodiments, the method of
manufacturing comprises shaping the distal tip of the needle 104
into a beveled or pencil point tip (e.g., by laser cutting,
grinding, chemical etching, etc.).
[0040] In some embodiments, for example as shown in FIG. 2, the
second lumen 318 optionally comprises (e.g., is at least partially
lined with) a guide tube 314. The guide tube 314 can comprise
(e.g., be made of), for example, 304 stainless steel hypodermic
tubing. Other materials are also possible. The distal end of the
guide tube 314 can comprise a modified Tuohy-style tip with a
radius between about 0.47 in. and about 0.53 in. (approx. between
about 1.19 cm and about 1.35 cm). Other radii of Tuohy-style tips
of the guide tube 314 are also possible, for example based on the
shape of the distal portion of the needle 104, catheter dimensions,
etc. A Tuohy-style distal tip of the guide tube 314 can be
substantially aligned with the exit port 106 so that the needle 104
can exit the guide tube 314 and the catheter 102 through the exit
port 106 as described in greater detail herein. The Tuohy-style tip
of the guide tube 314 can serve as a deflection surface (e.g., as
described herein) for the needle 104 to protect the interior of the
catheter 102 as the needle 104 exits the catheter 102 through the
exit port 106. In some embodiments, the guide tube 314 can be 20
gauge and have an outside cross-sectional diameter between about
0.03 in. and about 0.4 in. (approx. between about 0.076 cm and
about 0.102 cm) and an inside cross-sectional diameter between
about 0.025 in. and about 0.035 in. (approx. between about 0.064 cm
and about 0.089 cm). Other dimensions of the guide tube 314 are
also possible, for example based on dimensions of the needle 104,
dimensions of the catheter 102, etc. In some embodiments, the guide
tube 314 is adhered to the interior wall of the second lumen 318.
In some embodiments, the guide tube 314 is inserted into the second
lumen 318. In certain such embodiments, the shape of the guide tube
314 causes the guide tube 314 to remain properly positioned within
the lumen 318. In some embodiments, the guide tube 314 extends from
the proximal end 115 to the exit port 106. In certain such
embodiments, the guide tube 314 can have a length of about 22
in..+-.about 0.03 in. (approx. about 56 cm.+-.about 0.076 cm). In
some embodiments, only a portion, for example, about 0.5 in. to
about 1.5 in. (approx. about 1.3 cm to about 3.8 cm) of the second
lumen 318 proximate to the exit port 106 comprises a guide tube
314. Other lengths of the guide tube 314 are also possible (e.g.,
corresponding to the length of a straightened distal portion of the
needle 104).
[0041] In some embodiments, the guide tube 314 is cut (e.g., laser
cut) to maintain the flexibility of the catheter 102. The guide
tube 314 can advantageously add strength to the catheter 102,
inhibiting (e.g., preventing) torque, deformation of the distal
portion 200 that may be caused by the curved shape of the distal
portion of the needle 104, and/or skiving or other damage near the
exit port 106 caused by the needle 104. The guide tube 314 may also
beneficially keep the curved distal portion of the needle 104
straight while the distal portion of the needle 104 is inside the
catheter 102 and/or allow the needle 104 to move more freely within
the catheter 102 as compared to movement of a needle 104 in a
plastic, which may for example soften if heated to body
temperature. In some embodiments, a method of manufacturing an
endoluminal drug delivery device 100 comprises inserting the guide
tube 314 into the second lumen 318. In some embodiments, a method
of manufacturing the device 100 comprises cutting (e.g., laser
cutting) and/or shaping the guide tube 314. Other support
structures (e.g., a coil, a braid) are also possible to have some
of the advantages described herein.
[0042] In some embodiments, the device 100 optionally includes a
catheter lumen splitter or Y-connector 108 coupled to the catheter
102 proximate to the proximal end 115 of the catheter 102. In some
embodiments, a method of manufacturing an endoluminal drug delivery
device 100 comprises coupling a lumen splitter 108 to the catheter
102. In some embodiments, the splitter 108 has a length between
about 1 in. and about 2 in. (approx. between about 2.5 cm and about
5.0 cm). Other lengths are also possible (e.g., depending on the
dimensions of the catheter 102, the amount of split desired, etc.).
In some embodiments, the splitter 108 comprises high density
polyethylene (HDPE). Other materials are also possible. In some
embodiments, the splitter 108 comprises a first lumen 516 and a
second lumen 518. In some embodiments, the first and second lumens
516, 518 of the splitter 108 converge toward the distal end of the
splitter 108 to form a single lumen. In some embodiments, for
example as shown in FIG. 5A, as the catheter 102 passes through the
lumen splitter 108 from a distal end of the lumen splitter 108 to a
proximal end of the lumen splitter 108, the catheter 102 separates
into two single lumen components. The splitter 108 may
advantageously provide strength at the joint where the catheter 102
separates. In some embodiments, a portion of the catheter 102
comprising the first lumen 316 passes through the first lumen 516
of the splitter 108 and extends beyond the proximal end of the
lumen splitter 108 by about 4.5 in. to about 5.5 in. (approx. about
11.4 cm to about 14 cm). In some embodiments, a proximal end of the
portion of the catheter 102 comprising the first lumen 316
comprises a fitting, for example a Luer fitting (e.g., as
illustrated in FIG. 1). In some embodiments, the portion of the
catheter 102 comprising the first lumen 316 does not extend beyond
the proximal end of the lumen splitter 108, and the proximal end of
the splitter 108 comprises a fitting, for example a Luer
fitting.
[0043] In some embodiments, the needle 104 and a portion of the
catheter 102 comprising the second lumen 318 pass through the
second lumen 518 of the splitter 108 and extend about 3 in.
(approx. about 7.6 cm) beyond the proximal end of the splitter 108,
for example for coupling to a handpiece assembly 120. In some
embodiments, the guide tube 314 can also pass through the second
lumen 518 of the splitter 108 and extend beyond the proximal end of
the splitter 108, for example for coupling to a handpiece assembly
120. In some embodiments, for example as shown in FIG. 5B, the
guide tube 314 terminates within the splitter 108 and does not
extend beyond the proximal end of the splitter 108. In some
embodiments, for example as shown in FIG. 5B, the portion of the
catheter 102 comprising the second lumen 318 terminates within the
splitter 108. In certain embodiments, a separate piece of catheter
tubing 520 may optionally be attached (e.g., welded, glued,
adhered, mechanically crimped, mechanically swaged, combinations
thereof, and the like) to the proximal end of the splitter 108 in
fluid communication with the second lumen 518 of the splitter 108
and surrounding the needle 104. In some embodiments, a method of
manufacturing comprises attaching (e.g., welding, gluing, adhering,
mechanically crimping, mechanically swaging, combinations thereof,
and the like) a separate piece of catheter tubing 520 to the
proximal end of the splitter 108 in fluid communication with the
second lumen 518 of the splitter 108 and surrounding the needle
104.
[0044] The lumens 516, 518 of the splitter 108 and/or proximal
sections of the needle 104, guide tube 314, and/or catheter 102 can
be configured to angle away from the longitudinal axis of the
catheter 102. For example, a proximal portion of the portion of the
catheter 102 comprising the first lumen 316 can angle away from the
longitudinal axis of the catheter 102 in a first direction at an
angle .beta. to spatially separate the first lumen 316 of the
catheter 102 from the second lumen 318 of the catheter 102 and/or
to allow easier manipulation of a guidewire in the first lumen 316
of the catheter 102. In some embodiments, the angle .beta. is
between about 10.degree. and about 30.degree., between about
15.degree. and about 25.degree. (e.g., about 20.degree.),
combinations thereof, and the like. Other angles .beta. are also
possible, for example depending on the guidewire to be used (e.g.,
amount of manipulation room preferred for a guidewire, maximum
bending angle for a guidewire, etc.). For another example, proximal
portions of the second lumen 518 of the splitter 108, needle 104,
guide tube 314, and/or portion of the catheter 102 comprising the
second lumen 318 can angle away from the longitudinal axis of the
catheter 102 in a second direction (e.g., opposite to the first
direction) at an angle .gamma. to spatially separate the first
lumen 316 of the catheter 102 from the second lumen 318 of the
catheter 102 and/or to allow easier manipulation of a handpiece
assembly 120. In some embodiments, the angle .gamma. is between
about 10.degree. and about 30.degree., between about 15.degree. and
about 25.degree. (e.g., about 20.degree.), combinations thereof,
and the like. Other angles .gamma. are also possible, for example
depending on the handpiece assembly 120 to be used (e.g., amount of
manipulation room preferred for the handpiece assembly 120), the
needle 104 (e.g., maximum bending angle for the needle 104), etc.
Separation of the first and second lumens 316, 318 of the catheter
102 may advantageously allow for improved maneuverability of the
various components of the device 100 during use.
[0045] In some embodiments, the endoluminal drug delivery device
100 optionally includes a handpiece assembly 120. FIG. 6A shows an
exploded view of the handpiece assembly 120, and FIG. 6B shows a
longitudinal cross-sectional view of the assembled handpiece
assembly 120. The handpiece assembly 120 comprises a handle 110, a
driver 630, and a button 620. The handle 110 can be coupled to the
proximal end of the portion of the catheter 102 comprising the
second lumen 318, for example extending proximal to a lumen
splitter 108 as shown in FIG. 5A or otherwise. In some embodiments,
the handle 110 is coupled to a separate piece of catheter tubing
520 attached to the proximal end of a splitter 108 in fluid
communication with the second lumen 518 of the splitter 108 as
shown in FIG. 5B. Other connections are also possible (e.g.,
embodiments in which the device 100 does not comprise a lumen
splitter 108). In some embodiments, the handle 110 is coupled to
the guide tube 314. In some embodiments, the handle 110 is coupled
to or integrated with a splitter 108. The handle 110 may optionally
comprise a separate distal piece or nose 640 that is attached
(e.g., welded, glued, adhered, mechanically crimped, mechanically
swaged, combinations thereof, and the like) to the main body 642 of
the handle 110. In some embodiments, the nose 640 is integral with
the main body 642 of the handle 110 and is not a separate
component. Constructing the handle 110 with a separate nose 640 may
advantageously allow for easier manufacturing and/or assembly of
the handpiece assembly 120, allow rotation (e.g., ratcheting) of
the needle 104 relative to the catheter 102, etc. Constructing the
handle 110 with the nose 640 integral to the main body 642 may
advantageously reduce the number of pieces, reduce assembly
complexity, and/or reduce the likelihood of the pieces separating
during use.
[0046] When assembled, the driver 630 of the handpiece assembly 120
is inside the handle 110. The button 620 is inserted into a cutout
650 in the top of the handle 110 and snaps into a notch 652 in the
top of the driver 630. Other connections between the button 620 and
the driver 630 are also possible (e.g., adhering). The proximal end
of the needle 104 is attached to the distal end of the driver 630,
for example with adhesive (e.g., Class VI epoxy), over molding,
and/or other coupling techniques. The driver 630 translates
movement of the button 620 into movement of the needle 104. The
button 620 is used to distally longitudinally extend and proximally
longitudinally retract the needle 104 within the catheter 102, and
to cause the needle 104 to extend out of the exit port 106 and to
retract into the exit port 106. In some embodiments, the needle 104
is rotationally fixed relative to the catheter 102, for example due
to the catheter 102 being fixed to the lumen splitter 108 and
handle 110. In some embodiments, the button 620 slides in a track
660 and longitudinal movement of the button 620 causes 1:1
longitudinal movement of the needle 104 within the second lumen 318
of the catheter 102. In some embodiments, no handpiece assembly 120
is used, and instead the proximal end of the needle 104 is directly
manipulated.
[0047] In some embodiments, a method of manufacturing the device
100 includes assembling the handpiece assembly 120 and coupling the
handpiece assembly 120 to the device 100. For example, the driver
630 may be placed in the distal end of the handle 110 and rotated
until the notch is aligned with the cutout 650. The driver 630 may
then be coupled to the button 620 and the needle 104. In some
embodiments, a method of manufacturing comprises coupling the
handpiece assembly 120 (e.g., the handle 110 or the nose 640 of the
handle 110) to the catheter 102, the lumen splitter 108, a tube
520, etc.
[0048] In some embodiments, an endoluminal drug delivery system
comprises the endoluminal drug delivery device 100 and tubing 644
configured to fluidly couple the needle lumen to a drug delivery
system. The distal end of the tubing 644 can be coupled to the
proximal end of the driver 630 in the handle 110, for example via a
Luer fitting, a barb setting (e.g., as illustrated in FIG. 6B),
etc., and the proximal end of the tubing 644 can be coupled to the
drug delivery system. The tubing can comprise, for example, PVC
tubing. The tubing may comprise a flexible material so that the
movement of the needle 104 does not necessarily cause movement of
the drug delivery system.
[0049] FIGS. 7A and 7B illustrate an example embodiment of a drug
delivery system 700 comprising a bi-directional valve 740 coupled
to the proximal end of the tubing 644 via a barb (other coupling
techniques (e.g., a Luer fitting) are also possible), a syringe
742, and a drug source 744. In some embodiments, the valve 740
comprises a DCV Series double check valve available from Value
Plastics.RTM., Inc. of Fort Collins, Colo. The valve 740 can
comprise three ports: a chimney port 746 configured to be connected
to the fluid supply vessel or drug source 744, an aspiration port
748 configured to be connected to the syringe 742, and a fluid exit
port 750 configured to be connected to the tubing 644. The tubing
644 connects the fluid exit port 750 of the valve 740 to the needle
104 or driver 630.
[0050] To deliver fluid to the needle lumen and thus to the target
tissue, first the plunger of the syringe 742 is pulled back,
causing fluid to be drawn from the fluid supply 744 through the
chimney port 746, through the aspiration port 748, and then into
the syringe 742, as shown in FIG. 7A. The valve to the fluid exit
port 750 is pressurized so that fluid (e.g., blood) does not flow
from the tubing 644 into the syringe 742. When the plunger of the
syringe 742 is then pushed forward, the valve to the chimney port
746 is pressurized so that the fluid cannot travel back through the
chimney port 746, and fluid is expelled through the fluid exit port
750 as shown in FIG. 7B.
[0051] In some embodiments, the drug delivery system comprises a
pump connected to a drug source. In certain such embodiments, the
pump is configured to apply positive pressure or zero pressure so
that fluid (e.g., blood) does not flow from the needle 104 into the
drug source. Other drug supply systems are also possible. The
various components of the drug supply system can be connected to
each other and the needle or driver via Luer fittings or other
appropriate fittings.
Method of Delivering Fluid to Tissue
[0052] FIG. 8 shows an example embodiment of a method of delivering
a fluid to tissue 960 surrounding a body lumen 970. The method can
be performed using an endoluminal drug delivery device 100 and a
drug delivery system 700 as described herein. According to some
embodiments of the method, a guidewire 950 is percutaneously
inserted into the body lumen 970 through the body lumen wall 972,
for example, into a varicose or insufficient vein just below the
knee. The proximal end of the guidewire 950 is inserted into the
opening 112 of the catheter 102, and the distal end 116 of the
device 100 is inserted into the body lumen 970 by tracking the
first lumen 316 of the catheter 102 over the guidewire 950. When
the exit port 106 of the catheter 102 is in a first position, the
button 620 on the handpiece assembly 120 outside the body is
actuated to cause the distal portion of the needle 104 to exit the
catheter 102 through the exit port 106. The needle 104 continues
through the body lumen wall 972 and into the target tissue 960. If
there is no handpiece assembly 120, the needle 104 is directly
manipulated to cause the distal portion of the needle 104 to exit
the catheter 102 through the exit port 106 and continue through the
body lumen wall 972 into the target tissue 960. A syringe 742 or
pump is operated to deliver the drug to the tissue 960. The button
620 on the handpiece assembly 120 is actuated or the needle 104 is
directly manipulated to retract the needle 104 back into the
catheter 102.
[0053] In some embodiments of the method, the device 100 is then
again tracked over the guidewire 950 until the exit port 106 is in
a second position. The button 620 on the handpiece assembly 120 is
again actuated or the needle 104 is directly manipulated to cause
the distal portion of the needle 104 to exit the catheter 102
through the exit port 106 and continue through the body lumen wall
972 and into the target tissue 960. The syringe 742 or pump is
again operated to deliver the drug to the tissue 960, and the
needle 104 is retracted back into the catheter 102. The foregoing
process can be repeated for a desired number of positions.
[0054] In some embodiments, a method of delivering fluid to tissue
can be performed using an endoluminal drug delivery device 100 with
multiple exit ports 106a-106n, as described herein and illustrated
in FIG. 3C. Similarly to the method using a single exit port
device, a guidewire 950 is percutaneously inserted into the body
lumen 970, and the device 100 is inserted into the body lumen 970
by tracking the first lumen 316 of the catheter 102 over the
guidewire 950. When the device is inserted into the body lumen 970,
the needle 104 is positioned within the catheter such that the
distal end of the needle 104 is between the most distal exit port
106a and the second exit port 106b from the distal end 116 of the
catheter 102.
[0055] Once the catheter 102 is positioned within the body lumen
970, the button 620 on the handpiece assembly 120 outside the body
is actuated to cause the distal end of the needle 104 to exit the
catheter 102 through the most distal exit port 106a. The needle 104
continues through the body lumen wall 972 and into the target
tissue 960. Alternatively, if there is no handpiece assembly 120,
the needle 104 is directly manipulated to cause the distal end to
exit through the most distal exit port 106a and continue through
the body lumen wall 972 into the target tissue 960. A syringe 742
or pump is operated to deliver the drug to the tissue 960. The
button 620 on the handpiece assembly 120 is actuated or the needle
104 is directly manipulated to retract the needle 104 back into the
catheter 102. The catheter 102 is then held stationary within the
body lumen, and the needle 104 is moved proximally within the
second lumen 318 until the needle 104 exits the second exit port
106b from the distal end 116 of the catheter 102. If the device 100
comprises additional exit ports 106, this process can be
repeated.
[0056] The method of delivering a fluid to tissue surrounding a
body lumen 970 can be used, for example, to deliver numbing
medication to an area of tissue surrounding a target vein prior to
laser or RF ablation treatment for varicose or insufficient veins.
In some embodiments, the method of treatment further comprises
performing the ablation. The fluid may comprise a drug or
anesthetic such as tumescent, which can be, for example, lidocaine
possibly in combination with epinephrine, although the exact drug
and composition can vary by hospital, provider, patient, and/or
treatment.
[0057] Although this disclosure has been described in the context
of certain embodiments and examples, it will be understood by those
skilled in the art that the disclosure extends beyond the
specifically disclosed embodiments to other alternative embodiments
and/or uses and obvious modifications and equivalents thereof. In
addition, while several variations of the embodiments of the
disclosure have been shown and described in detail, other
modifications, which are within the scope of this disclosure, will
be readily apparent to those of skill in the art. It is also
contemplated that various combinations or sub-combinations of the
specific features and aspects of the embodiments may be made and
still fall within the scope of the disclosure. It should be
understood that various features and aspects of the disclosed
embodiments can be combined with, or substituted for, one another
in order to form varying modes of the embodiments of the
disclosure. Furthermore, dimensions of various components provided
herein are exemplary, and other dimensions may be used. Thus, it is
intended that the scope of the disclosure herein should not be
limited by the particular embodiments described above.
* * * * *