U.S. patent number RE36,857 [Application Number 08/355,141] was granted by the patent office on 2000-09-05 for interlocking peel-away dilation catheter.
This patent grant is currently assigned to SciMed Life Systems, Inc.. Invention is credited to Daniel O. Adams, Charles L. Euteneuer.
United States Patent |
RE36,857 |
Euteneuer , et al. |
September 5, 2000 |
Interlocking peel-away dilation catheter
Abstract
A dilatation balloon catheter which is capable of being removed
from a patient while leaving a guide wire in place has a
longitudinal slit extending from its proximal end to a position
near its inflatable balloon. The catheter has an inflation lumen
for applying fluid to inflate the balloon, and an insertion lumen
through which the guide wire passes. The slit communicates with the
insertion lumen so that the catheter can be peeled off of the guide
wire as the catheter is withdrawn from the patient and the guide
wire remains in place in the patient.
Inventors: |
Euteneuer; Charles L. (St.
Michael, MN), Adams; Daniel O. (Blaine, MN) |
Assignee: |
SciMed Life Systems, Inc.
(Maple Grove, MN)
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Family
ID: |
26862738 |
Appl.
No.: |
08/355,141 |
Filed: |
December 13, 1994 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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166976 |
Mar 10, 1988 |
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Reissue of: |
554182 |
Jul 18, 1990 |
05171222 |
Dec 15, 1992 |
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Current U.S.
Class: |
604/103.1;
604/160; 606/194 |
Current CPC
Class: |
A61M
25/104 (20130101); A61M 2025/1079 (20130101) |
Current International
Class: |
A61M
29/02 (20060101); A61M 029/00 (); A61M
005/178 () |
Field of
Search: |
;604/96-102,160,161
;606/192,194,198 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: McDermott; Corrine M.
Attorney, Agent or Firm: Crompton, Seager & Tufte
LLC.
Parent Case Text
This is a continuation of application Ser. No. 166,976 filed on
Mar. 10, 1988, abandoned as of the date of this application.
Claims
What is claimed is:
1. A catheter which is insertable and removable over a guide wire
which has one end adapted for insertion into a vessel of a patient
and an opposite end which extends outside of the patient, the
catheter comprising:
a tubular member having a proximal end, a distal end, a first lumen
for transmitting fluid, and a second lumen through which the guide
wire passes;
an inflatable balloon carried by the tubular member adjacent the
distal end and in communication with the first lumen;
wherein the tubular member includes a longitudinal opening through
a side wall of the tubular member and connected to the second
lumen, the longitudinal opening extending from adjacent the
proximal end of the tubular member to a position spaced from a
proximal end of the inflatable balloon and dividing the side wall
into first and second wall portions on opposite sides of the
longitudinal opening, with the longitudinal opening permitting
movement of the guide wire through the longitudinal opening as the
tubular member is removed from the patient while the guide wire
remains in the patient; interlocking means carried adjacent
longitudinal free edge portions of the first and second wall
portions, and including first interlocking means carried at a
longitudinal free edge of the first wall portion and second
interlocking means carried at a longitudinal free edge of the
second wall portion, the first and second interlocking means being
selectively interlockable to close the longitudinal opening;
and
a generally cylindrical sleeve member slidably mounted about the
tubular member, the sleeve member having a tubular section through
which the guide wire extends and which disengages the interlocking
means and locally spreads apart the longitudinal opening to permit
passage of the tubular section and guide wire therethrough.
2. The catheter of claim 1 wherein the interlocking means includes
a pair of cooperable resilient flaps which resiliently closes the
longitudinal opening to prevent passage of the guide wire
therethrough with a first flap extending along the longitudinal
free edge portion of the first wall portion and overlapping a
second flap extending along the longitudinal free edge portion of
the second wall portion.
3. The catheter of claim 2 wherein the flaps have thinner wall
sections adjacent the longitudinal opening and thicker wall
sections away from the opening.
4. The catheter of claim 1 wherein the tubular section of the
sleeve member includes an insertion hub having:
a first tubular portion generally axially aligned with the tubular
member and positioned within the second lumen;
a second tubular portion extending at an angle from the first
tubular section outward through the longitudinal opening; and
wherein the guide wire passes through the first and second portions
of the insertion hub.
5. The catheter of claim 4 wherein the second tubular portion of
the insertion hub includes a luer fitting through which the guide
wire passes.
6. The catheter of claim 4 wherein the sleeve member includes:
a side port therethrough for the second tubular portion; and
wherein the sleeve member is slidable on the tubular member of the
catheter over a span of the longitudinal opening.
7. The catheter of claim 1 wherein the sleeve member includes at
least one exterior rib which extends circumferentially about the
sleeve member for facilitating gripping of the sleeve member.
8. The catheter of claim 1 wherein the tubular member includes a
stop collar adjacent the proximal end for limiting the motion of
the sleeve member in a proximal direction.
9. The catheter of claim 1 wherein a distance from the position
spaced from the proximal end of the inflatable balloon to the
distal tip of the catheter is approximately ten inches.
10. The catheter of claim 1 wherein the first and second
interlocking means further comprise:
a first C-shaped hook and a second C-shaped hook, the first
C-shaped hook extending along the longitudinal free edge of the
first wall portion and being cooperable with the second C-shaped
hook extending along the longitudinal free edge of the second wall
portion.
11. The catheter of claim 1 wherein the first and second
interlocking means further comprise:
a first ramp-shaped hook and a second ramp-shaped hook, the first
hook extending along the longitudinal free edge of the first wall
portion and being cooperable with the second hook extending along
the longitudinal free edge of the second wall portion.
12. The catheter of claim 1 wherein the first and second
interlocking means further comprise:
a first barb-shaped hook and a second barb-shaped hook, the first
hook extending along the longitudinal free edge of the first wall
portion and being cooperable with the second hook extending along
the longitudinal free edge of the second wall portion.
13. The catheter of claim 1 wherein the first and second
interlocking means further comprise:
a rib portion and a groove portion, the rib portion extending along
the longitudinal free edge of the first wall portion and being
cooperable with the groove portion extending along the longitudinal
free edge of the second wall portion.
14. A method of removing a balloon catheter from a patient while
leaving a guide wire in place with a proximal end of the guide wire
outside the patient and a distal end of the guide wire within the
patient, the method comprising:
providing a generally cylindrical stripper hub about a proximal end
of the balloon catheter which extends outside of the patient;
applying force to the balloon catheter at its proximal end in a
direction which causes the balloon catheter to be withdrawn
proximally through the stripper hub and out of the patient;
maintaining the guide wire in an essentially stationary position,
by grasping the stripper hub and maintaining the stripper hub in an
essentially stationary position relative to the patient to cause a
longitudinal slit in a side wall of the balloon catheter to open by
separating interlocked interlocking means carried on opposing wall
portions of the side wall defining the slit, as the balloon
catheter passes proximally through the stationary stripper hub and
to permit the guide wire to pass generally laterally out through
the longitudinal slit in the side wall of the balloon catheter
until a remaining length of the catheter positioned over the guide
wire is shorter than a length of the guide wire extending outside
the patient; and
removing the remaining length of balloon catheter proximally off of
the guide wire.
15. The method of claim 14 wherein the applying force step and the
maintaining the guide wire position step are performed
simultaneously.
16. The method of claim 14 and further comprising:
grasping a portion of the guide wire located distally of a distal
tip of the balloon catheter when that portion of the balloon
catheter becomes exposed outside of the patient.
17. The method of claim 16 wherein the grasping step and the
removing step are performed essentially simultaneously.
18. A method of exchanging a first angioplasty dilation catheter in
a patient with a second angioplasty dilation catheter while leaving
a guide wire in place with a proximal end of the guide wire outside
the patient and a distal end of the guide wire within the patient,
the method comprising:
providing a generally cylindrical stripper hub about a proximal end
of the first angioplasty dilation catheter which extends outside of
the patient;
applying force to the first catheter at its proximal end in a
direction which causes the first catheter to be withdrawn
proximally through the stripper hub and out of the patient;
maintaining the guide wire in an essentially stationary position,
by grasping the stripper hub and maintaining the stripper hub in an
essentially stationary position relative to the patient to cause a
longitudinal slit in a side wall of the first catheter to open by
separating interlocked interlocking means carried on opposing wall
portions of the side wall defining the slit as the first balloon
catheter passes proximally through the stationary stripper hub and
to permit the guide wire to pass laterally out through the
longitudinal slit in the side wall of the first catheter and
through a side port in the stripper hub until a remaining length of
the first catheter positioned over the guide wire is shorter than
length of the guide wire extending outside the patient;
removing a remaining length of the first catheter proximally off of
the guide wire;
threading the second angioplasty dilation catheter onto the
proximal end of the guide wire; and
inserting the second angioplasty dilation catheter into the patient
and over the guide wire within the patient.
19. A catheter which is insertable and removable over a guide wire,
the catheter comprising:
an inflatable balloon;
a shaft supporting the balloon at a distal end thereof, and having
an inflation port at a proximal end thereof, the shaft having an
inflation lumen extending from the inflation port to an interior of
the balloon and a guide wire lumen extending through the interior
of the balloon, with the guide wire lumen comprising means for
releasably holding a guide wire adjacent to the inflation lumen
along substantially an entire length of the shaft and said guide
wire lumen including interlocking parting means for permitting the
shaft and the guide wire to be peeled away from one another along
substantially the entire length of the shaft; and
a generally cylindrical sleeve member mounted about the shaft which
is capable of relative longitudinal movement with respect to the
shaft for causing the parting means to unlock and be parted,
thereby permitting the shaft and guide wire to be peeled apart.
.Iadd.
20. A balloon catheter, comprising:
a. an elongate shaft having a proximal end, a distal end, an
exterior and a guide wire lumen extending therethrough, the distal
end of the shaft including an inner tube disposed in an outer tube,
the elongate shaft also having a longitudinal slit extending
distally from the proximal end of the shaft to provide access to
the guidewire lumen from the exterior of the shaft, wherein the
slit is defined between adjacent flaps when the slit is open, and
wherein the flaps provide structural strength to the shaft when the
slit is closed;
b. an inflatable balloon having a proximal end and a distal end,
the proximal end of the balloon connected to the distal end of the
shaft;
c. a guide wire having a proximal end and a distal end, the distal
end being disposed in the guide wire lumen and the proximal end
being laterally displaced from the elongate shaft; and
d. a sliding member disposed on the elongate shaft and extending at
least partially into the longitudinal slit, the sliding member
engaging the guide wire disposed in the guide wire lumen.
.Iaddend..Iadd.21. A balloon catheter as in claim 20, wherein a
distal end of the inner tube is connected to the distal end of the
balloon and a distal end of the outer tube is connected to the
proximal end of the balloon. .Iaddend..Iadd.22. A balloon catheter
as in claim 21, wherein the inner tube is about 10 inches long.
.Iaddend..Iadd.23. A balloon catheter, comprising:
a. a proximal shaft having a proximal end, a distal end, an
exterior and a proximal guide wire lumen extending therethrough,
the proximal shaft also having a longitudinal slit to provide
access to the proximal guide wire lumen from the exterior of the
shaft, wherein the slit is defined between adjacent flaps when the
slit is open and wherein the flaps provide structural strength to
the proximal shaft when the slit is closed;
b. an outer tube having a proximal end and a distal end, the
proximal end of the outer tube connected to the distal end of the
proximal shaft;
c. an inner tube having a proximal end, a distal end and a distal
guide wire lumen extending therethrough, the inner tube disposed in
the outer tube to define an annular lumen therebetween; and
d. a balloon having a proximal end and a distal end, the proximal
end of the balloon connected to the distal end of the outer tube,
the distal end of the balloon connected to the distal end of the
inner tube. .Iaddend..Iadd.24. A balloon catheter as in claim 23,
further comprising:
e. a sliding member disposed on the proximal shaft and extending at
least
partially into the longitudinal slit. .Iaddend..Iadd.25. A balloon
catheter as in claim 24, further including a guide wire disposed in
the proximal guide wire lumen, wherein the sliding member engages
the guide wire. .Iaddend..Iadd.26. A balloon catheter as in claim
25, wherein the inner tube is about 10 inches long.
.Iaddend..Iadd.27. A balloon catheter, comprising:
a. a first shaft having a proximal end, a distal end, a first
inflation lumen extending therethrough, and a first guide wire
lumen extending therethrough, the first shaft also having a slit
extending therealong to provide access to the first guide wire
lumen, wherein the slit is defined between adjacent flaps when the
slit is open, and wherein the flaps provide structural strength to
the first shaft when the slit is closed;
b. a second shaft having a proximal end, a distal end, a second
inflation lumen extending therethrough, and a second guide wire
lumen extending therethrough, the proximal end of the second shaft
connected to the distal end of the first shaft, the second shaft
having a length of about 10 inches; and
c. a balloon connected to the distal end of the second shaft.
.Iaddend..Iadd.28. A balloon catheter as in claim 27, wherein the
slit terminates at the distal end of the first shaft.
.Iaddend..Iadd.29. A balloon catheter as in claim 27, further
comprising:
d. a sliding member disposed in the slit. .Iaddend..Iadd.30. A
balloon catheter as in claim 29, further including a guide wire
disposed in the proximal guide wire lumen, wherein the sliding
member engages the guide wire. .Iaddend..Iadd.31. A balloon
catheter as in claim 30, wherein the slit terminates at the distal
end of the first shaft. .Iaddend..Iadd.32. A balloon catheter,
comprising:
a. an elongate shaft having a proximal end, a distal end, an
exterior, a guide wire lumen, an inflation lumen, and a
longitudinally-extending lateral opening which provides access to
the guide wire lumen from the exterior of the shaft, wherein the
lateral opening is defined between adjacent flaps when the lateral
opening is open, and wherein the flaps provide structural strength
to the shaft when the lateral opening is closed;
b. an inflatable balloon connected to the distal end of the
elongate shaft, the inflatable balloon being in fluid communication
with the inflation lumen;
c. a guide wire disposed in the guide wire lumen; and
d. a sleeve member slidably disposed on the shaft, the sleeve
member including a portion which penetrates the lateral opening
into the guide wire lumen and at least partially surrounds the
guide wire disposed in the guide wire lumen, the portion of the
shaft proximal of the sleeve member remaining substantially
coaxially aligned with the portion of the shaft distal of the
sleeve member. .Iaddend..Iadd.33. A balloon catheter as in claim
32, wherein the longitudinally extending lateral opening extends to
a point about 10 inches proximal of the balloon. .Iaddend..Iadd.34.
A balloon catheter as in claim 32, wherein the distal end of the
elongate shaft includes an inner tube disposed in an outer
tube.
.Iaddend..Iadd. A balloon catheter as in claim 34, wherein a distal
end of the inner tube is connected to a distal end of the balloon
and a distal end of the outer tube is connected to a proximal end
of the balloon. .Iaddend..Iadd.36. A balloon catheter as in claim
35, wherein the inner tube is about 10 inches long. .Iaddend.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention.
The present invention relates to the field of angioplasty. In
particular, the present invention relates to dilatation balloon
catheters which are insertable into a patient over a guide
wire.
2. Description of the Prior Art.
Angioplasty has gained wide acceptance in recent years as an
efficient and effective method for treating certain types of
vascular diseases. In particular, angioplasty is widely used for
opening of stenosis in the coronary arteries, although it is also
used for treatment of stenoses in other parts of the vascular
system.
The most widely used form of angioplasty makes use of a balloon
catheter which has an inflatable balloon at its distal end. Using
fluoroscopy, the physician guides the catheter through the vascular
system until the balloon is positioned across the stenosis. The
balloon is then inflated by supplying fluid under pressure through
an inflation lumen to the balloon. The inflation of the balloon
causes stretching of the artery and pressing of the lesion into the
artery wall to reestablish acceptable blood flow through the
artery.
Guide wires are often used for establishing the path to the
stenoses so that the balloon catheter can subsequently be
positioned. The guide wire normally is advanced through the
stenosis, and commonly is left in place during the inflation of the
balloon.
Balloon catheters used for angioplasty are available in different
balloon diameters. There are instances in which it becomes
necessary to exchange one size of balloon catheter for another
during an angioplasty procedure. When this happens, it is very
advantageous to leave the guide wire in place while the first
balloon catheter is removed. This allows the second balloon
catheter to be reinserted without having to first reestablish the
path by inserting a new guide wire.
In the past, however, the removal of the balloon catheter without
removing the guide wire has been complicated because the balloon
catheter is inserted over the guide wire. To remove the balloon
catheter, while leaving the guide wire in place, there must be a
portion of the guide wire extending out of the balloon catheter at
the proximal end so that the guide wire can be gripped and held in
place as the balloon catheter is removed.
One solution is to remove the initial guide wire while leaving the
catheter in place and then inserting an "exchange wire" in its
place. The exchange wire is long enough so that the portion of its
length extending outside of the patient is longer than the length
of the catheter. This allows a portion of the exchange wire to be
available for gripping at all times regardless of the position of
the catheter. There are, however, several problems with this
approach. The use of an exchange wire essentially doubles the
normal length of the guide wire, which makes the exchange wire
difficult to handle and manipulate. This extra length is normally
of no use to the physician during angioplasty, since exchanging
catheters is
required only in a fraction of the total number of angioplasty
procedures. The extra steps of exchanging the guide wire for an
exchange wire and the increased difficulty of handling a wire of
much greater length have been required in the past in order to
exchange balloon catheters. A more convenient and easier to use
system would be desirable.
SUMMARY OF THE INVENTION
The present invention is a balloon catheter which can be removed
from a patient over a standard length guide wire (typically about
150 cm) without removing the guide wire from the patient. The
catheter of the present invention includes means for opening a
longitudinal slit which communicates with the insertion lumen
through which the guide wire passes. The slit extends from near the
proximal end of the catheter to a position near the inflatable
balloon, so that the length of the catheter which does not contain
a slit is shorter than the length of guide wire normally located
outside of the patient and extending beyond the proximal end of the
catheter.
To remove the catheter from the patient, the guide wire is held in
place while the catheter is removed from the patient. The guide
wire exits the catheter through the slit, so that as the catheter
is withdrawn from the patient, the distance between the exit of the
guide wire from the catheter and the distal end of the catheter
becomes progressively shorter. In other words, the catheter tube is
"peeled away" from the guide wire as the catheter is withdrawn from
the patient. When the catheter has reached a position in which the
distal end of the catheter is outside of the patient and the guide
wire can be grasped beyond the distal end of the catheter, the
remainder of the catheter can be pulled off of the proximal end of
the guide wire.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a sectional view of the peel-away dilatation balloon
catheter of the present invention, with the balloon shown in an
inflated condition.
FIG. 2 is a sectional view along section 2--2 of FIG. 1 showing the
dual lumen catheter tube of the peel-away catheter of FIG. 1.
FIGS. 3A and 3B show sectional views of the proximal end portion of
the peel-away dilatation catheter of FIG. 1 illustrating movement
of the catheter tube with respect to the stripper hub as the
catheter is withdrawn from the patient while the guide wire stays
in place.
FIGS. 4A and 4B are sectional views illustrating a method of
forming an alternate construction of the dual lumen catheter
tube.
FIGS. 5A and 5B, 6A and 6B, 7A and 7B and 8A and 8B are sectional
views illustrating other embodiments of the dual lumen catheter
tube with resealable slits.
FIG. 9 is a sectional view of the proximal end of another
embodiment of the peel-away catheter of the present invention.
FIG. 10 is a sectional view of the distal end of still another
embodiment of the peel-away catheter.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Peel-away dilatation balloon catheter 10 of the present invention
shown in FIG. 1 includes a dual lumen catheter tube 12 which has an
inflation lumen 14 and a through lumen or insertion lumen 16.
Mounted at distal end 18 of tube 12 is inflatable balloon 20.
Inflation lumen 14 opens into the interior of balloon 20. Also
shown within the interior of balloon 20 is a mid-balloon radiopaque
marker 22, which is useful for identifying the location of balloon
20 by fluoroscopy.
In a preferred embodiment of the present invention, tube 12 is an
extruded dual lumen tube made from polyethylene. Balloon 20 is
formed from a polymer material such as polyolefin, and is bonded to
tube 12 at the proximal and distal ends of balloon 20 by a suitable
adhesive, such as an epoxy.
At proximal end 24 of catheter tube 12, inflation port 26 is
connected through strain relief sleeve 28 to inflation lumen 14.
Inflation port 26 is preferably a luer fitting which is attached to
an inflation device (not shown).
As shown in FIGS. 1 and 2, tube 12 has a longitudinally extending
opening or slit 30 which communicates with insertion lumen 16. Slit
30 extends from proximal end 24 of tube 12 to end point 32, which
is located near the proximal portion of inflation balloon 20. The
slit 30 is resiliently closed under normal conditions, however, it
may be forcibly opened. In a preferred embodiment, the distance D
between distal tip 34 of catheter 10 and end point 32 of slit 30 is
approximately ten inches. This distance D is selected to be less
than a normal length of catheter guide wire which extends outside
beyond the proximal end of the catheter during an angioplasty
procedure.
In FIG. 1, peel-away catheter 10 is shown in place on guide wire
36, which may be of any conventional design (including a "dilating
guide wire" which has a small diameter balloon at its distal end).
The distal end of guide wire 36 extends out through distal tip 34
of catheter 10. Guide wire 36 extends all the way through insertion
lumen 16 and out insertion lumen hub 38 at the proximal end 24 of
catheter 10. .Iadd.As illustrated in FIG. 1, the guide wire 36 is
laterally displaced from the proximal end 24 of the catheter 10.
.Iaddend.Insertion lumen hub 38 includes a first tubular section 40
which is generally axially aligned with catheter tube 12 and is
positioned within insertion lumen 16. Hub 38 also has a second
tubular portion 42 which extends at an angle outward through slit
30. The outer end of tubular section 42 carries a luer fitting 44.
Insertion lumen hub 38 is carried by and is movable with stripper
hub 46.
Stripper hub 46 is a generally cylindrical sleeve having a pair of
ribs 48 for gripping and having a side port 50 through which tube
section 42 of insertion lumen hub 38 extends. Stripper hub 46 is
slidable in an axial direction along the length of catheter tube 12
between the position shown in FIG. 1 and a position which is
limited by the end point 32 of slit 30. Stop collar 52 is attached
to the proximal end of catheter tube 12 to stop the proximal motion
of stripper hub 46 and prevent it from being removed off the
proximal end of catheter tube 12.
Catheter 10 of the present invention has the advantage of being
able to be removed from the patient while leaving guide wire 36 in
place. FIGS. 3A and 3B, together with FIG. 1, illustrate the
"peel-away" removal of catheter 10 over guide wire 36. .Iadd.As
illustrated in FIGS. 3A and 3B, the guide wire 36 is laterally
displaced from the catheter tube 12. .Iaddend.
In FIG. 3A, the withdrawal of catheter 10 from the patient has
begun. By comparing FIG. 3A with FIG. 1, it can be seen that
stripper hub 46 is no longer adjacent proximal end 24 of tube 12.
This is accomplished by the physician by holding stripper hub 46 in
place, while applying force to the proximal end of cathether 10 so
that relative movement of catheter tube 12 with respect to stripper
hub 46 is taking place. FIG. 3B shows catheter 10 at a position
where end point 32 has reached stripper hub 46. At this point
distal tip 34 is either outside of the guide catheter (not shown)
or can be pulled outside the guide catheter by proximal movement of
catheter 10, so that it is possible for the physician to grasp a
portion of guide wire 36 distally of tip 34. The remaining distance
D of catheter 10 can be pulled off of the guide wire 36 without
disturbing guide wire 36, because it is possible to grasp guide
wire 36 at a position between distal tip 34 and the guide
catheter.
Once catheter 10 has been removed from guide wire 36, a different
dilatation catheter of either the same, or different construction
can be threaded over guide 36 and into the patient. Through the
entire procedure, the distal end of guide wire 36 has remained in
place within the patient. This is advantageous because it avoids
the time required to reinsert the guide wire; it avoids the cost of
an exchange wire and the handling problems associated with an
exchange wire; and it reduces the danger involved in recrossing a
freshly crossed lesion.
FIGS. 4A and 4B illustrate an alternative embodiment of the present
invention. As shown in FIG. 4A, catheter tube 60 is a dual lumen
tube having an inflation lumen 62 and a through lumen or insertion
lumen 64. Slit 66 extends through the wall of tube 60 in an area of
reduced wall thickness to divide the outer wall of tube 60 into two
flaps 68 and 70.
As shown in FIG. 4B, tube 60 is then compressed or heat formed so
that flap 70 overlaps flap 68 (or vice versa). This overlapping
provides greater structural strength for tube 60, while still
allowing flaps 68 and 70 to be parted as there is relative movement
between stripper hub 46 and tube 60.
FIGS. 5A and 5B, 6A and 6B, 7A and 7B, and 8A and 8B illustrate
other embodiments which feature extruded dual lumen tubing with
resealable slits. The advantages of a resealable slit are that no
blood leakage occurs, and that the through lumen can also be used
for blood pressure measurement and distal dye delivery.
In FIGS. 5A and 5B, catheter tube 80 is a dual lumen tube having an
inflation lumen 82 and a through lumen 84. Slit 86 (which is open
in FIG. 5A and closed in FIG. 5B) divides the outer wall of tube 80
into flaps 88 and 90. C-shaped hooks 92 and 94 at the edges flaps
88 and 90 respectively, run longitudinally the length of slit 86,
and engage one another to seal slit 86 as shown in FIG. 5B. The
seal provided by hooks 92 and 94 can be broken to open slit 86 by
relative movement of stripper hub 46.
The embodiments shown in FIGS. 6A and 6B, 7A and 7B, and 8A and 8B
are generally similar to FIGS. 5A and 5B (and similar reference
numerals are used). In FIGS. 6A and 6B, ramp hooks 96 and 98
replace C-shaped hooks 92 and 94. In FIGS. 7A and 7B, barbs 100 and
102 replace hooks 92 and 94. In FIGS. 8A and 8B, ball 104 and
socket 106 replace hooks 92 and 94.
FIG. 9 shows the distal portion of another embodiment of the
peel-away catheter which is generally similar to the embodiment of
FIGS. 1-3, and similar reference characters are used. The
embodiment of FIG. 9 include knife blade 110 which is carried by
stripper hub 46. Relative movement of stripper hub 46 toward the
distal end of catheter 10 cause knife blade 110 to cut a slit in
tubing 12 (which was extruded without a slit). The advantage of
this embodiment is that until the time of slitting no blood leakage
can occur and blood pressure measurements and distal dye delivery
can be accomplished by using through lumen 16.
FIG. 10 shows the distal portion of still another embodiment of the
peel-away catheter. In this embodiment, dual lumen tubing 120 can
take any one of several forms, including the forms shown and
discussed previously. Tubing 120 has an inflation lumen 122 and a
through lumen 124. At its distal end, tubing 120 has a reduced
diameter bonding region 126 to which balloon waist 128 is bonded.
Through lumen 124 extends distally slightly beyond inflation lumen
122 and has an extension inner lumen 130 connected at its distal
end. Connected to balloon waist 128 is inflatable balloon segment
132 (shown inflated). Balloon waist 128, inflatable balloon segment
132 and distal bond segment 134 may be a one-piece (integral)
construction or may be formed of different materials. Distal bond
segment 134 is bonded to the distal end of inner lumen 130.
In FIG. 10, the longitudinal slit in tubing 120 extends to point
136, which is near bonding region 126. The distance from point 136
to the distal tip of the catheter is approximately ten inches.
In conclusion, the peel-away catheter of the present invention
provides a simple yet very effective way of performing an
angioplasty dilatation catheter exchange without having to remove
the guide wire from the patient. With the present invention, it is
not necessary to provide a guide wire of excessive length for those
occasions where a catheter exchange is required, and yet the
physician can make an exchange quickly and simply in those cases
where it becomes apparent that catheter exchange is necessary.
Another important advantage of the present invention is that it
provides maximum pushability through the patient because the guide
wire 36 supports catheter 10 along its entire length.
During insertion of a catheter 10 of this design, the tripper hub
46 may be located at the proximal end 24 of slit 30 and insertion
made by a traditional threading onto guide wire 36.
Alternatively, stripper hub 46 and insertion hub 38 may be located
near the patient. In this arrangement, the catheter tubing 12 is
pushed through the stripper hub 46, resiliently closes over the
guide wire 36 and enters the patient.
Although the present invention has been described with reference to
preferred embodiments, workers skilled in the art will recognize
that changes may be made in form and detail without departing from
the spirit and scope of the invention.
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