U.S. patent number 3,769,984 [Application Number 05/123,242] was granted by the patent office on 1973-11-06 for pacing catheter with frictional fit lead attachment.
This patent grant is currently assigned to Sherwood Medical Industries Inc.. Invention is credited to Lloyd D. Muench.
United States Patent |
3,769,984 |
Muench |
November 6, 1973 |
PACING CATHETER WITH FRICTIONAL FIT LEAD ATTACHMENT
Abstract
A device for transvenous insertion such as for use in connection
with transmitting electrical pulses in a heart pacer. The device
comprises a catheter having highly flexible electrical conductors
spaced apart therein connected to a pair of spaced electrodes at
the distal end for delivering a pacing signal. The conductors are
formed of stranded tantalum filaments of extremely small
cross-section. The catheter may include an axial lumen through
which blood pressure measurements may be taken as well as
permitting extension of guide wires therethrough for guiding the
catheter as during venous insertion. The device may comprise an
extruded plastic element with the conductor wires being coextruded
therein for facilitated manufacture.
Inventors: |
Muench; Lloyd D. (Berea,
OH) |
Assignee: |
Sherwood Medical Industries
Inc. (St. Louis, MO)
|
Family
ID: |
22407515 |
Appl.
No.: |
05/123,242 |
Filed: |
March 11, 1971 |
Current U.S.
Class: |
607/122 |
Current CPC
Class: |
A61N
1/056 (20130101); A61N 1/36564 (20130101) |
Current International
Class: |
A61N
1/375 (20060101); A61N 1/05 (20060101); A61N
1/372 (20060101); A61N 1/365 (20060101); A61n
001/04 () |
Field of
Search: |
;128/404,418,419P,2.7S |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Lillehei et al., "Journal of American Medical Association," Vol.
172, No. 18, Apr. 30, 1960, pp. 2,006-2,010.
|
Primary Examiner: Kamm; William E.
Claims
I claim:
1. A transvenous pacing catheter comprising an elongate element
formed of a flexible, electrically insulating material suitable for
transvenous insertion, a tubular metal member surrounding a distal
end portion of said element in tight frictional engagement, a
tubular electrode surrounding said metal member in generally
concentric relation therewith, and a stranded bundle of metal
filaments each having a diameter under approximately 50 microns and
defining an electrical conductor embedded in said element and
extending from a proximal end portion toward the distal end portion
thereof, said conductor having a distal end portion emerging from
said element and extending between said metal member and said
electrode in tight frictional engagement therebetween to provide a
current conductive connection between said electrode and the
proximal end portion of said conductor.
2. The transvenous pacing catheter of claim 1 wherein said metal
member has a radially inwardly deformed portion receiving the
distal end portion of said conductor.
3. The transvenous pacing catheter according to claim 1 wherein the
distal end portion of said conductor emerges from said element at a
location distally of said metal member and extends toward the
proximal end portion of said element.
4. The transvenous pacing catheter of claim 1 further including a
second tubular metal member surrounding the distal end portion of
said element in tight frictional engagement and in axially spaced
relation from said electrode, a second electrode having a tubular
portion surrounding said second metal member in generally
concentric relation therewith, and a second stranded bundle of
metal filaments each having a diameter under approximately 50
microns and defining a second electrical conductor embedded in said
element and extending from the proximal end portion toward the
distal end portion thereof, said second conductor emerging from
said element and extending between said second metal member and
said tubular portion of said second electrode in tight frictional
engagement therebetween to provide a current conductive connection
between said second electrode and the proximal end portion of said
second conductor.
5. The transvenous pacing catheter of claim 4 wherein the distal
end portion of said second conductor emerges from said element at a
location distally of said second metal member and extends toward
the proximal end of said element.
6. The transvenous pacing catheter of claim 5 wherein said second
electrode is generally cup-shaped with an outer substantially
rounded distal end defining the distal tip of the catheter.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to transvenous insertion devices and in
particular to insertion devices suitable for use in connection with
transmitting electrical pulses in heart pacers.
2. Description of the Prior Art
In the conventional heart pacer means, a pulse conducting element
is provided in the form of an elongated flexible device which may
be guided through a vein of the patient to dispose the distal end
thereof in electrical connection association with the heart muscle.
The proximal end of the device is connected to a voltage source,
such as a battery, which may also be implanted in the patient's
body. The voltage source includes means delivering time-spaced
pulses to the heart muscle for suitably regulating, or pacing, the
heart pumping action.
It is extremely important that the electrical conductors of the
device remain unbroken notwithstanding the flexing thereof
occurring in the use of the device. The device must be extremely
small and flexible for transvenous insertion into the heart and for
limited interference with the normal body functions. Further, the
device must be resistant to effect by body fluids, and reversely,
must be physiologically inert so as to not adversely affect the
patient when implanted therein.
SUMMARY OF THE INVENTION
The present invention comprehends an improved electrical conductor
device suitable for use as a pervenous heart pacing electrode,
particularly for use in acute or emergency situations. The device
comprises an elongated plastic catheter having a pair of electrical
conductors extending from suitable leads at the proximal end to
suitable spaced electrodes at the distal end. The conductors may
comprise wires formed of stranded tantalum filaments having
extremely small cross-section providing high flexibility. The
catheter may be formed as a plastic extrusion with the wires being
coextruded therein.
Since the catheter of this invention is intended for use primarily
as an acute transvenous pacing catheter, as in an emergency wherein
the catheter is fed to the heart through a vein and is used for
only a relatively short period of time (e.g., 1 day to 3 weeks),
extreme flexibility is essential so that the catheter may be fed
into the vein and "floated" by the normal blood flow in the vein to
the right vertical or atrium of the heart. It should also be noted,
however, that this extreme flexibility also permits prolonged
implantation in other than emergency situations providing a highly
durable and break-resistant structure.
The catheter may be provided with an axial lumen for providing
functioning in addition to the pacing function, as desired.
The distal electrode may comprise a cup-shaped element defining the
leading tip of the catheter. Alternatively, the distal electrode
may comprise a cylindrical electrode spaced rearwardly of a rounded
tip of the plastic element.
The catheter may have a circular cross-section for facilitated
transvenous insertion.
BRIEF DESCRIPTION OF THE DRAWING
Other features and advantages of the invention will be apparent
from the following description taken in connection with the
accompanying drawing wherein:
FIG. 1 is a side elevation of a pacing catheter embodying the
invention;
FIG. 2 is a fragmentary enlarged side elevation thereof
illustrating more clearly the electrical connections therein;
FIG. 3 is a fragmentary further enlarged diametric section of the
distal end thereof;
FIG. 4 is a further enlarged transverse cross-section taken
substantially along the line 4--4 of FIG. 3;
FIG. 5 is a further enlarged transverse cross-section taken
substantially along the line 5--5 of FIG. 3;
FIG. 6 is a fragmentary diametric section of the distal end of a
modified form of pacing catheter embodying the invention; and
FIG. 7 is a fragmentary diametric section of still another form of
pacing catheter embodying the invention provided with an axial
lumen.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
In the exemplary embodiment of the invention as disclosed in FIGS.
1-5 of the drawing, a bipolar transvenous pacing catheter generally
designated 10 is shown to comprise an elongated element 11 formed
of a flexible, electrically insulating material suitable for
transvenous insertion. A first electrode 12 is provided at the
distal end 13 of the elongated element, and a second electrode 14
is provided spaced rearwardly from electrode 12. A first electrical
conductor 15 is extended longitudinally through elongated element
11 to have the distal end 16 thereof electrically connected to
electrode 12. A second electrical conductor 17 is extended
longitudinally through elongated element 11 to have the distal end
18 thereof electrically connected to electrode 14. Conductor 15
includes an input lead portion 19 and conductor 17 includes an
input lead portion 20 brought out from the element 11 at the
proximal end 21 thereof. Suitable electrical connecting means may
be provided at leads 19 and 20 and may be suitably color-coded for
identification of the respective conductors 15 and 17. Any suitable
method of effecting the electrical connection may be employed as
will be obvious to those skilled in the art.
Catheter 10 may have a suitable length for use in conducting
electrical pulses from an external or implanted battery power
source to the heart muscle of the patient. Thus, illustratively,
the catheter may have a length of approximately 100 centimeters.
Element 11 is preferably circular in outer cross-section and may
have a diameter of approximately 0.05 inch for facilitated
transvenous insertion. Element 11 is preferably formed of a
physiologically inert material, such as silicone rubber. Other
suitable flexible plastic materials, such as polyvinyl chloride,
may be used, as will be obvious to those skilled in the art.
Element 11 may be formed by extrusion and conductors 15 and 17 may
be coextruded therewith for facilitated manufacture. Electrodes 12
and 14 may have axial lengths of approximately 3 mm. and may be
spaced apart approximately 1 cm. at distal end 13 of element
11.
Electrical conductors 15 and 17 comprise stranded wires of highly
flexible, small diameter metal filaments. The invention comprehends
the provision of such wires formed of filaments having a diameter
of under approximately 50 microns. Preferably, the filaments are
twisted such as with a conventional twist of approximately 5 turns
per inch. Illustratively, the electrical conductors may comprise
270 strands each of 12 micron filaments. An excellent filamentary
material for such use comprises tantalum, although metals such as
platinum, silver or stainless steel may also be used. The tantalum
wires may be anodized such as with a 20 to 25 volt film.
As best seen in FIG. 3, the conductors 15 and 17 comprise stranded
filament bundles, or wires, electrically connected to the
respective electrodes 12 and 14 by means of crimp rings 22 and 23,
respectively. The crimp rings are preferably similarly formed of
tantalum and have a length approximately one-half the axial length
of the electrodes. In effecting the connection of the wires to the
electrodes, the ends 16 and 18 of the conductors are brought out
from the element 11 at a point adjacent the distal end of the crimp
ring. The conductor is then folded back toward the proximal end of
the device. The electrode is then slipped over the lead and crimp
ring to clamp the end of the conductor therebetween. For
facilitated installation of the crimp ring on the element 11, the
element may be axially stretched to reduce its cross-section
permitting the crimp ring to be moved thereover to the desired
position. Upon release of the element 11, the expansion thereof
provides a snug arrangement of the crimp ring at the desired
location. The electrode elements may be crimped about the crimp
rings to provide maintained association thereof. Upon installation
of the electrodes, the assembly may be dipped in a suitable
adhesive material to fill the bores from which the conductors may
be removed in bringing the ends 16 and 18 outwardly from element
11. As will be obvious to those skilled in the art, other suitable
methods of connecting the electrodes to the conductors may be
employed, such as welding, soldering, etc.
As best seen in FIG. 3, electrode 14 may comprise a tubular
electrode. Electrode 12 may comprise a cup-shaped electrode
defining a rounded distal tip 24.
As shown in FIG. 6, a modified form of distal electrode generally
designated 112 is shown to comprise a tubular electrode similar to
electrode 14 with the distal tip 124 of element 111 extending
forwardly beyond the electrode 112 to define the leading end of the
device. Thus, in the arrangement of FIG. 6, connection of conductor
115 to electrode 112 may be similar to the connection described
above relative to electrode 14.
As indicated briefly above, the invention comprehends the provision
of a tubular element in lieu of the solid cross-section element 11
when desired. Thus, as shown in FIG. 7, a pacing cathode generally
designated 210 is shown to comprise a tubular elongated element 211
having embedded in the wall thereof electrical conductors 215 and
217 connected to electrodes 212 and 214 similarly as the connection
of conductors 15 and 17 to electrodes 12 and 14 in catheter 10.
Catheter 210 differs from catheter 10 solely in the provision of
the axial lumen 225. In illustrating catheter 210, a cup-shaped
distal electrode 212 is shown which effectively closes lumen 225,
with a suitable opening or port being provided as desired along the
length of the catheter. If desired, however, a cylindrical
electrode, such as electrode 112 of FIG. 6, may be provided,
permitting the lumen to be used for additional functions such as
for use in making blood pressure measurements. Further, the lumen
is adapted to accept guide wires and the like for guiding the
catheter during the insertion process. Illustratively, where the
lumen has a diameter of approximately 0.016 inch a 0.015 inch
stainless steel stylet may be used therewith.
Thus, the disclosed catheters are extremely simple and economical
of construction while yet providing a highly reliable pervenous or
transvenous structure such as for use in electrically pacing a
heart muscle. The catheters utilize extremely small diamater
stranded filament tantalum wires permitting "floating" insertion
into the heart and long trouble-free life notwithstanding the
substantial flexing thereof occurring in such heart pacer use.
It should be understood that the present invention may also be used
in those heart pacing procedures wherein a single electrode or
unipolar device is inserted into the heart with the patient's body
serving as a common electrical ground return between the heart and
the power source. For use in applications such as this, only a
single conductor would be extruded in the catheter and only a
single distal electrode would be provided.
The foregoing disclosure of specific embodiments is illustrative of
the broad inventive concepts comprehended by the invention.
* * * * *