U.S. patent application number 10/411790 was filed with the patent office on 2004-01-01 for catheter hub with detachable push device.
Invention is credited to Chi, David.
Application Number | 20040002678 10/411790 |
Document ID | / |
Family ID | 27766416 |
Filed Date | 2004-01-01 |
United States Patent
Application |
20040002678 |
Kind Code |
A1 |
Chi, David |
January 1, 2004 |
Catheter hub with detachable push device
Abstract
A handle member for gripping a catheter shaft to facilitate
advancement in a patient's body lumen. The handle member is
configured to be releasably secured to the catheter shaft. Further,
the handle is longitudinally displaceable along at least a length
of the catheter shaft, so as to be slidably positional along the
shaft. The handle member may be detachably connected to an adapter
on the proximal end of the catheter shaft. Additionally, one
embodiment of the handle member has internal grooves on the outer
wall of the handle member, so that the user would have finger
placement holds. The handle member may be made of a softer material
than the catheter shaft, and have a tapered outer surface for
comfort of the user.
Inventors: |
Chi, David; (Cerritos,
CA) |
Correspondence
Address: |
FULWIDER PATTON LEE & UTECHT, LLP
HOWARD HUGHES CENTER
6060 CENTER DRIVE
TENTH FLOOR
LOS ANGELES
CA
90045
US
|
Family ID: |
27766416 |
Appl. No.: |
10/411790 |
Filed: |
April 11, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10411790 |
Apr 11, 2003 |
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09590946 |
Jun 9, 2000 |
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6613014 |
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Current U.S.
Class: |
604/93.01 ;
604/57 |
Current CPC
Class: |
A61M 2025/0063 20130101;
A61M 25/0097 20130101; A61M 2025/09116 20130101; A61F 2/9517
20200501 |
Class at
Publication: |
604/93.01 ;
604/57 |
International
Class: |
A61M 031/00 |
Claims
What is claimed is:
1. A handle member for gripping a catheter shaft to facilitate
advancement in a patient's body lumen comprising a body having a
proximal end, a distal end, at least one lumen and a connecting
member, configured to be releasably secured to the catheter shaft
and when released to be longitudinally displaceable along at least
a length of the catheter shaft so as to be slidably positional
along the shaft.
2. The handle member of claim 1, wherein the connecting member
frictionally engages the catheter shaft when secured thereto.
3. The handle member of claim 1, wherein the connecting member is
chosen from a group consisting of clips, clamps, clasps, vises,
locks, snaps, o-ring valves and rotational hemostatic valves.
4. The handle member of claim 1, wherein the connecting member
comprises a) a cap having a head and a body with threads, the body
extending within the handle member lumen; b) threads on the handle
member lumen complimentary to the threads on the cap body; and c) a
compressible member within the handle member lumen.
5. The handle member of claim 1, wherein the handle member lumen
has an inner diameter of no less than 0.040 inches (1.016
millimeters).
6. The handle member of claim 1, wherein the handle member has an
outer diameter of about 0.5 inches (12.7 millimeters) to about 2.0
inches (50.8 millimeters).
7. The handle member of claim 6 wherein the body has a center
section, and the handle member outer diameter at the center section
is smaller than the outer diameter at the proximal end, and the
handle member outer diameter at the center section is smaller than
the outer diameter at the distal end.
8. The handle member of claim 7, having a proximal tapered portion
between the center section and the proximal end and a distal
tapered section between the center section and the distal end.
9. The handle member of claim 1 wherein the body has a deformation
configured to enhanced a user's grip.
10. The handle member of claim 1 wherein the body has an outer wall
with internal grooves.
11. The handle member of claim 10 wherein the grooves are
configured in the shape of at least 2 ovals.
12. The handle member of claim 11 wherein the oval shapes are
configured to receive a user's fingers.
13. The handle member of claim 1, wherein the handle member lumen
has an inner diameter of no less than 0.040 inches (1.016
millimeters).
14. The handle member of claim 1, wherein the handle member has an
outer diameter of about 0.5 inches (12.7 millimeters) to about 2.0
inches (50.8 millimeters).
15. The catheter assembly of claim 14 wherein the handle member has
a center section, and the handle member outer diameter at the
center section is smaller than the outer diameter at the proximal
end.
16. The catheter assembly of claim 15, having a proximal tapered
portion between the center section and the proximal end and a
distal tapered section between the center section and the distal
end.
17. A catheter assembly comprising a) a catheter shaft having a
proximal end, a distal end and at least one lumen; and b) A handle
member for gripping a catheter shaft to facilitate advancement in a
patient's body lumen comprising a body having a proximal end, a
distal end, at least one lumen and a connecting member, configured
to be releasably secured to the catheter shaft and when released to
be longitudinally displaceable along at least a length of the
catheter shaft so as to be slidably positional along the shaft.
18. The handle member of claim 17, wherein the connecting member
frictionally engages the catheter shaft when secured thereto.
19. The catheter assembly of claim 17 wherein the handle member is
a softer material than the catheter shaft.
20. The catheter assembly of claim 17, further comprising an
adapter attached to the catheter shaft proximal to the handle
member.
21. The handle member of claim 17 wherein the body has a
deformation configured to enhanced a user's grip.
22. The catheter assembly of claim 17 wherein the body has an outer
wall with internal grooves.
23. The catheter assembly of claim 22 wherein the grooves are
configured in the shape of at least 2 ovals.
24. The catheter assembly of claim 23 wherein the oval shapes are
configured to receive a user's fingers.
25. A catheter assembly comprising a) a catheter shaft having a
proximal end, a distal end and at least one lumen; b) an adapter
attached to the proximal end of the catheter shaft; and c) a handle
member for gripping a catheter shaft comprising a body having a
proximal end, a distal end, at least one lumen and a connecting
member, configured to be releasably secured to the catheter shaft
and when released to be longitudinally displaceable along at least
a length of the catheter shaft so as to be slidably positional
along the shaft.
26. The catheter assembly of claim 25 wherein the adapter has
threads on a distal portion, and the handle member has
complimentary threads on the handle member proximal end.
Description
BACKGROUND OF THE INVENTION
[0001] This invention generally relates to intravascular catheters,
such as balloon catheters used in percutaneous transluminal
coronary angioplasty (PTCA) and stent delivery.
[0002] PTCA is a widely used procedure for the treatment of
coronary heart disease. In this procedure, a balloon dilatation
catheter is advanced into the patient's coronary artery and the
balloon on the catheter is inflated within the stenotic region of
the patient's artery to open up the arterial passageway and thereby
increase the blood flow there through. To facilitate the
advancement of the dilatation catheter into the patient's coronary
artery, a guiding catheter having a preshaped distal tip is first
percutaneously introduced into the cardiovascular system of a
patient by the Seldinger technique through the brachial or femoral
arteries. The catheter is advanced until the preshaped distal tip
of the guiding catheter is disposed within the aorta adjacent the
ostium of the desired coronary artery, and the distal tip of the
guiding catheter is then maneuvered into the ostium. A balloon
dilatation catheter may then be advanced through the guiding
catheter into the patient's coronary artery over a guidewire until
the balloon on the catheter is disposed within the stenotic region
of the patient's artery.
[0003] The balloon is inflated to open up the arterial passageway
and increase the blood flow through the artery. Generally, the
inflated diameter of the balloon is approximately the same diameter
as the native diameter of the body lumen being dilated so as to
complete the dilatation but not over expand the artery wall. After
the balloon is finally deflated, blood flow resumes through the
dilated artery and the dilatation catheter can be removed
therefrom.
[0004] In a large number of angioplasty procedures, there may be a
restenosis, i.e. reformation of the arterial plaque. To reduce the
restenosis rate and to strengthen the dilated area, physicians now
frequently implant an intravascular prosthesis called a stent
inside the artery at the site of the lesion. Stents may also be
used to repair vessels having an intimal flap or dissection or to
generally strengthen a weakened section of a vessel. Stents are
usually delivered to a desired location within a coronary artery in
a contracted condition on a balloon of a catheter which is similar
in many respects to a balloon angioplasty catheter, and expanded to
a larger diameter by expansion of the balloon. The balloon is
deflated to remove the catheter and the stent is left in place
within the artery at the site of the dilated lesion.
[0005] In both applications, the catheter must be advanced through
the body to the heart. Control and advancement of catheters is
difficult because of their construction. The body of conventional
catheters is long and tubular. The user must frequently manipulate,
or torque, the catheter shaft on the proximal end to facilitate
advancement of the catheter with a desired orientation on the
distal end. To provide the needed control over the movement of the
catheter, it is necessary that these tubular catheters be made
somewhat rigid. However, catheters must be flexible enough to
navigate through the body lumen to arrive at the desired location
within the body where the medical procedures will be performed. An
overly rigid catheter shaft will not track, or follow, the
guidewire. Therefore, reaching the desired location with the rigid
catheter is more difficult. In addition, the catheter shaft is
lubricious and smooth. A lubricious shaft is necessary to
facilitate advancement within the body lumen. A user may have
difficulty creating a sufficient grip on the catheter shaft.
[0006] Therefore, what has been needed is a device that improves
torquability of the catheter without interfering with the tracking
and advancing of the catheter. The present invention satisfies
these and other needs.
SUMMARY OF THE INVENTION
[0007] The present invention is directed to a handle member for
gripping a catheter shaft to facilitate advancement on a patient's
body lumen. The handle member is configured to be releasably
secured to the catheter shaft. Further, the handle is
longitudinally displaceable along at least a length of the catheter
shaft, so as to be slidably positional along the shaft. The handle
member is comprised of a proximal end, a distal end, at least one
lumen extending therethrough, and a connecting member.
[0008] The proximal end and the distal end of the handle member
each have ports. The ports are completely surrounded by the handle
member material. The catheter shaft passes through the proximal end
port, advances through the lumen and passes through the distal end
port. The handle member may be slidably positional on the catheter
shaft. In such an embodiment, the connecting member in the handle
member can be engaged to connect with the catheter shaft upon
reaching a desired position. The connecting member frictionally
engages the catheter shaft. The connection allows the handle member
to secure to the catheter shaft, so the handle member will not
move.
[0009] In one embodiment of the invention, the handle member is
disposed about a catheter shaft having an adapter attached to the
proximal end of the catheter shaft. The handle member is disposed
about the catheter shaft at a location distal to the adapter. In
yet another embodiment, the handle member is detachably connected
to the adapter.
[0010] The handle member may have a connecting member of any type
that would adequately grip the catheter shaft. Such connecting
members include, but are not limited to clips, clamps, clasps,
vises, locks and valves. Specifically, a rotational hemostatic
valve is an adequate connecting member. A rotational hemostatic
valve ("RHV") generally utilizes a three-piece assembly. First, the
RHV has a sleeve. The interior of the sleeve had threads. For this
invention, the sleeve may be the distal end of the handle member.
The RHV also has a cap that extends partially within the sleeve.
The cap has threads corresponding to the sleeve internal threads.
The third piece is an O-ring, or other compressible member. The cap
will compress the compressible member when it is turned within the
sleeve. The compressible member then grips the catheter shaft,
anchoring the RHV.
[0011] An important aspect of this invention is not only the
additional control it would grant the user, but the added comfort
the user would experience. This is especially true for long
procedures. An embodiment of the invention has outer walls, and a
taper between the proximal and distal ends and the center of the
handle member on the outer wall. This embodiment allows for more
comfortable prolonged gripping. Another embodiment includes a
deformation of the outer walls in such a way as to enhance user
comfort. A specific embodiment defines internal grooves on the
outer wall of the handle member. A user may prefer to use such
internal grooves as finger holds, allowing the user to have a
secure hold on the handle member without an uncomfortable grip. The
user is thereby able to work with more control for a long period of
time.
[0012] Additionally, the handle may be manufactured from a material
that is softer than the catheter shaft. Therefore, a wide variety
of soft polymeric materials allow for a comfortable grip.
Specifically, a thermoplastic rubber such as Santoprene.RTM.
thermoplastic rubber from Advanced Elastomer Systems, a soft and
sticky material, is a successful material. Alternatively, a
polycarbonate may form the push device to provide support and
strength, with a layer of Santoprene.RTM. added to provide a better
grip.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is an elevational view of the catheter system
embodying features of the invention, with a handle member attached
to an adapter.
[0014] FIG. 2 is an elevational view of the proximal portion of the
catheter system of FIG. 1, with the handle member attached to an
adapter.
[0015] FIG. 3 is a transverse cross sectional view of the catheter
system of FIG. 2 taken along the line 3-3.
[0016] FIG. 4 is a longitudinal cross sectional view of the
catheter system of FIG. 2 taken along the line 4-4 with the
connecting member engaged.
[0017] FIG. 5 is a transverse cross sectional view of the catheter
system of FIG. 4 taken along the line 5-5.
[0018] FIG. 6 is a longitudinal cross sectional view of the
catheter system of FIG. 2 taken along the line 44 with the
connecting member disengaged.
[0019] FIG. 7 is a transverse cross sectional view of the catheter
system of FIG. 6 taken along the line 7-7.
DETAILED DESCRIPTION OF THE INVENTION
[0020] As shown in FIG. 1, the catheter 10 embodying features of
the invention generally includes a catheter shaft 11 having a
proximal end 12, a distal end 13, an adapter 14, and a handle
member 22 slidably disposed about and capable of being releasably
secured to the catheter shaft 11 at a location distal to an adapter
14. In the embodiment shown in FIG. 1, the handle member 22 is
detachably connected to the adapter 14.
[0021] As shown in detail in FIGS. 2-7, the handle member 22 has a
proximal end 23 and a distal end 24. The proximal end 23 has a
proximal port 25 for receiving the catheter shaft 11. The distal
end 24 has a distal port 26 for receiving the catheter shaft 11.
The handle member 22 has at least one lumen 27 between the proximal
port 25 and the distal port 26, which receives the catheter shaft
11. The handle member 22 is about 1 to about 2 inches long. The
lumen 27 defines an inner diameter. The inner diameter of the lumen
27 is generally no less than about 0.040 inches (1.016
millimeters).
[0022] The handle member 22 has an outer diameter. In one
embodiment, the outer diameter is not constant. Specifically, the
outer diameter is larger at the handle member proximal end 23 and
distal end 24 than the outer diameter at any point between the
proximal end 23 and distal end 24. The outer diameter will range
from about 0.5 inches (12.7 millimeters) to about 2.0 inches (50.8
millimeters). In certain embodiments, the outer diameter tapers
from a larger to a smaller transverse dimension from the proximal
end 23 to the center 28 of the handle member 22, and from a smaller
to a larger transverse dimension from the center 28 to the distal
end 24.
[0023] The handle member preferably has a deformation on the outer
surface to enhance comfort of the grip for the user. This
deformation may be a texture on the outer surface, for example a
sandpaper texture (not shown). The deformation may also include a
design in the outer surface to conform to the user's hand (not
shown). The deformation may also be a specific removal of material
from the outer surface to enhance finger placement, such as a
dimple or a slot (not shown). In one embodiment of the invention
illustrated in FIG. 3, the handle member 22 may have internal
grooves 37 in the sides. These grooves 37 will allow for
comfortable finger placement during long procedures and a generally
more ergonomic grip. Certain embodiments may have at least two
internal grooves 37. Another embodiment may have the internal
grooves 37 shaped as ovals. Specifically, these internal grooves 37
are configured to receive a physician's fingers. In such an
embodiment, the circle created before forming the internal grooves
37 defines the outer diameter. The embodiment illustrated in FIG. 3
has four oval shaped grooves 37. However, any number of internal
grooves would be adequate for this invention.
[0024] The handle member 22 has a connecting member 29 to connect
the handle member 22 to the catheter shaft 11. The connecting
member 29 may be, but is not limited to, any available clip, clamp,
clasp, vise, lock or snap. Specifically, the system used in a
rotational hemostatic valve would be an adequate connecting member
29. In the embodiment shown in FIG. 4, the connecting member 29
consists of a cap 30 and a compressible ring 31 within a distal
portion of the handle member lumen 27. In that embodiment, the
connecting member 29 frictionally engages the catheter shaft 11
when secured thereto.
[0025] The cap 30 has a lumen 32 for receiving the catheter shaft
11. Similarly, the compressible ring 31 has a lumen 38 for
receiving the catheter shaft 11. The cap 30 has a head 33 and a
body 34. The body 34 extends within the handle member lumen 27. The
body 34 has external threads 35 at least partially along the body's
34 longitudinal axis. The handle member 22 has internal threads 36,
which compliment the external threads 35 on the body 34, on the
distal end of the lumen 27. For the purposes of this patent,
complimenting threads are threads that can receive each other. When
the physician turns the head 33, the external threads 35 follow the
internal threads 36 and rotate, moving the cap 30 toward the handle
member proximal end 23.
[0026] The proximal movement will compress the compressible ring
31. The compressible ring 31 has a lumen 38, which disappears as
the compressible ring 31 contacts the catheter shaft 11. The
further the physician turns the head 33, the more proximal the body
34 will travel and the compressible ring 31 will compress to form a
firm grip on the catheter shaft 11. FIG. 5 shows the connecting
member 29 engaged to grip the catheter shaft 11. FIG. 6 shows the
cap 30 open so the compressible ring 31 does not engage the
catheter shaft 11. Compressible ring lumen 38 is clearly visible in
FIG. 7.
[0027] Referring back to the embodiment illustrated in FIG. 1, the
catheter 10 is an over-the-wire catheter. The catheter shaft 1 1
has an outer tubular member 17 and an inner tubular 16 disposed
within the outer tubular member 17 and defining, with the outer
tubular member 17, an annular inflation lumen 18. Inflation lumen
18 is in fluid communication with an inflatable balloon 15.
Inflation fluid is introduced into the inflation port 19 on the
adapter 14, travels through the inflation lumen 18, and inflates
the balloon 15. The inner tubular member 16 has an inner lumen 21
extending therein, which is configured to slidably receive a
guidewire 20 suitable for advancement through a patient's coronary
arteries. The distal extremity of the balloon 15 is sealingly
secured to the distal extremity of the inner tubular member 16, and
the proximal extremity of the balloon 15 is sealingly secured to
the distal extremity of the outer tubular member 17.
[0028] Although individual features of embodiments of the invention
may be shown in some of the drawings and not in others, those
skilled in the art will recognize that individual features of one
embodiment of the invention can be combined with any or all the
features of another embodiment.
* * * * *