Note: Descriptions are shown in the official language in which they were submitted.
i
CA 02054396 2002-04-29
64407-102
ADAPTER FOR CATHETER INTRODUCER, AND RELATED METHOD
BACKGROUND OF THE INVENTION
1. FIELD OF THE INVENTION
The field of the invention is to an adapter for a
catheter introducer, and related method, wherein a catheter
is passed into the body in order to transmit a medium either
into or from the body through a lumen in the catheter. Of
particular interest are heart catheters which are introduced
into the heart for monitoring the heart by having its
waveforms transmitted from the heart through a lumen in the
catheter. The invention will accordingly be described in
detail hereinafter by reference to heart catheters wherein
the medium transmitted is the waveform for heart monitoring.
2. DESCRIPTION OF THE RELATED ART
The problems involved in the prior art occur when
the catheter contains a lumen for transmitting waveforms for
monitoring a heart, which lumen can easily be crushed and/or
1
~Q~4396
have any of its transmitted waveforms distorted.
The related prior art has two types of potential
problemse Type A problems, Type B problems, and Tvpe C
problems.
Type A problems are illustrated by: (1) the Prior Art
Tuohy-Borst adapter in Fig. 1 of the Prior Art drawing in the
present application; and (2) the related Steigerwald U.S.
Patent '346 mentioned first herein.
Type A problems are illustrated by Tuohy-Borst
adapter 15 in Fig. 1 for a catheter introducer. It includes
adjustable compression cap 17; latex washer 18 forming a seal
around catheter 26 to prevent air leaks toward the patient and
fluid leaks away from the patients silicone compression sleeve
19 squeezing around catheter 26 when top cap 17 is tightened to
hold catheter 26 in place: hemostasis valve 23 utilizing a
duckbill, one-silt design to reduce the potential of air entry
and blood loss when catheter 26 is not in place; and nylon
washer 20 used to transmit an even force on valve 23, so that
valve 23 is positioned correctly in body 21 housing hemostatic
valve 23 and compression sleeve 19.
Tuohy-Borst adapter 15 is currently used to secure in
place a pulmonary catheter having a lumen, after the catheter
has been properly positioned. Problems occur because of the
inability of its user to control automatically how much
compression cap 17 is tightened, so that the lumen is not
crushed or any of its transmitted waveforms distorted.
- 2 -
2054396
Adjustable cap 17 is tightened to secure its catheter
26 in place after catheter 26 has been properly axially
positioned. However, if compression cap 17 is tightened too
much, catheter 26 may become crushed and its transmitted
waveforms distorted; but if cap 17 is not tightened enough,
catheter 26 will not be properly secured in the position
desired against movement relative to adapter 16.
Consider the uncontrolled tightening action: (1) by
compression cap 17 on silicone sleeve 19 in adapter 15 in Fig.
1 of the Prior Art drawing in the present application; and (2)
on elastic sleeve 112 in Patent '346 (see lines 33-45, column
7). This uncontrolled tightening is likely to crush any lumen
carried by catheter 26, and distort its transmitted waveforms.
Tvpe B problems are illustrated by U.S. Patent No.
4,000,739 (hereinafter called "Patent '739), patented January
4, 1977 by Robert C. Stevens and entitled HEMOSTASIS CANNULA.
In Type B: Patent '739 operates in a different manner
than gland 48 in the present application, since cannula 10, 12
in patent '739: (1) relies on the support of gasket 22 to
close slit 28 to resist the force exerted by the patient's
blood pressure and prevents any blood loss (see lines 40-45,
column 3); (2) does not have a mechanism for adjusting the
compression, i.e., tightening down around its catheter 46 to
immobilize it in place for preventing it from migrating from
the desired fixed position; and (3) in its commercially sold
form has its cap 12 and body portion 10 welded together, so its
disc 22 or 24 cannot be replaced.
- 3 -
205439fi
Type C problems are illustrated by U.S. Patent No.
4,177,814 (hereinafter called "Patent '814), patented December
11, 1979 by William R. Knepshield and entitled SELF-SEALING
' CANNULA.
In Ty~C: Patent '814 has a trocar, which is a
surgical instrument with a rigid metal shaft 18; and is not
relevant to the catheter (and to its adapter, art and problems)
disclosed in this application. When its rigid metal shaft 18
is removed, air entry and blood loss is prevented by
automatically closing sealing slot 30 in valve 26 due to the
compressive force (see lines 39-41, column 3). The force
required to automatically close its central sealing slot 30 is
likely to be sufficient force to crush any lumen carried by any
catheter, and to distort its transmitted waveforms.
Adapter 32 of the present'invention is an improvement
on, and solves and eliminated the aforementioned defects and
problems in, the prior arts takes the "guess work" out of the
operations and is designed: (1) to provide maximum resistance
to any catheter 34 pull-out force, and (2) not to crush lumen
35 carried by catheter 34, or to distort any catheter
monitoring wave forms transmitted by its lumen 35.
SIJr~MARY OF THE INVENTION
The invention relates to any adapter 32 for a
catheter introducer 31 wherein catheter 34 is passed into the
heart for monitoring the heart by having its waveforms
transmitted from the heart through lumen 35 in catheter 34.
Coupling means 95 is provided for compressing compression gland
48 against catheter 34 in a controlled manner in a catheter
- 4 -
2U5439G
gripping position in Fig. 13, when compression member 46 is
positively stopped by engagement of stop shoulders 78 and 94,
so that maximum resistance to catheter 34 pull-out is provided
without distorting any waveform transmitted by lumen 35. A
related method is provided for sizing and using compression
glands) 48.
One object of the invention is to provide an adapter
for a catheter introducer, and related method, designed: (1)
to provide maximum resistance to any catheter 34 pull-out
force, and (2) not to distort any catheter monitoring waveform
transmitted by its lumen 35.
A further object of the present invention is to
provide for an adapter fox a catheter introducer, a method for
sizing and using interchangeable glands in the adapter.
A further object of the present invention is to
provide an adapter for a catheter introducer, and related
method, characterized by its ease of assembly of its component
parts and ease of use of its method steps, structural and
method simplicity, many desirable operating and use features,
multiplicity of functional advantages for some of its component
structural parts and method steps, attractive exterior
appearance, and safe, reliable and precise operating
characteristics.
These and other objects, novel features and
additional advantages of the present invention will become more
clearly apparent to one skilled in the pertinent art by
reference to the appended claims as the following detailed
description of the preferred embodiments(s) of the invention
- 5 -
CA 02054396 2003-O1-20
64407-102
and discussion proceeds in conjunction with the accompanying
drawing, wherein like elements are given like reference
numerals throughout. The drawing is not necessarily to
scale; emphasis instead is being placed upon illustrating
the principles of the invention.
The invention may be summarized according to one
aspect as an adapter kit for a catheter introduces for. a
catheter, comprising: a body member having a cavity; an
elastomeric means in said cavity; a campression member
aligned with said cavity, said compression member having a
tubular plunger aligned with said cavity; said body member
having a mouth in said cavity far receiving said tubular
plunger, said mouth having a bore lip having an internal
dimension less than the internal dimensions of said cavity;
said elastomeric means being selected from two silicone
elastomeric glands with approximately a 40 Shore A durometer
hardness, each oi= different. length, having approximately the
same outside dimension for fitting interchangeably in said
cavity, so that the glands can be used interchangeably, each
with a different outside dimensioned catheter gripped by the
compression of a different length glax~.d; said elastomeric
glands each being cut in a different length from the same
extrusion and having a bore of approximately the same cross
sectional dimensions, said elast.omeric gland being
telescoped over the catheter; said elastomeric glands having
outside diameters greater than the internal dimension of
said bore lip and fitting into the internal dimension of
said cavity, so that said glands can be telescoped through
said mouth into said cavity arid detachably held in said
cavity by said bare lip; and a coupling means responsive to
bringing together and connecting said members for
6
CA 02054396 2003-O1-20
64407-102.
compressing said elastomeric means against the catheter by
said compression member in a controlled ~~anner in a catheter
gripping position, said gripping position being the same in
use with either elastomera_c gland so that the catheter. is
not adversely crushed.
According to anather aspect the invention provides
an adapter kit for a catheter :~.ntroducer for a catheter, the
catheter having a specific~ outside dimension and at least
one lumen containing a medium for transmitting a waveform,
the wavef.orm being responsive to a compression of the
catheter, said adapter kit. comprising; a body member having
a cavity; an elastomeri_c means within said cavity, said
elastomeric means being an elastomeric gland having a
preselected length for use with the specific outside
diameter of the catheter, said gland having above and being
telescoped over the cat:het.er, the elastomeric gland being
selected from a plurality of interchangeable annular
cylindrical elastomeric glands cut from the same extrusion,
each having the same inside diameter and the same outside
diameter, said glands having d:ifferent lengths, each f:or use
with a different size catheter having a different outside
diameter; a compression member aligned with said cavity,
said compression membex° having a plunger aligned with said
cavity; a coupling means for bringing together said body
member and said compressian member into a catheter gripping
position, said gripping position being the same in use with
each elastomeric gland, resulting in the compression of said
bore of said gland and the outside diameter of the catheter,
so that the catheter is gripped by said gland without
distorting the tr_ansmit:ted waveform.
According to yet, another aspect the invention
provides a method of sizing an elastomeri.c gland located in
6a
CA 02054396 2003-O1-20
64407-102
a cavity of a body member and compressed against a catheter
by a compression membe.r_ moving toward said gland, comprising
the steps of inserting the gland. into the cavity, moving the
compression member toward said cavity, gland and body member
to a catheter gripping force on the catheter, measuring the
compressive force on the catheter, and correcting the size
of said gland, so that a ~>reselected compressive force is
not exceeded.
BRIEF DESCRIPTION OF THE DRAWING
In the drawings,
Fig. 1 is longitudinal, exploded view of a prior
adapter for a catheter int.roducer;
Fig. 2 is a side elevational. view of the catheter
introducer with its component adapter of the present
invention, and of portions of its associated catheter and
sidearm;
Fig. 3 is a side elevational view of the catheter
introducer of Fig. 2 w~.th its component adapter shown in
longitudinally exploded view;
Fig. 4 is a transverse, sectional view taken
generally along line 4--4 i.n Fig. 3;
Fig. 5 is a transverse, section".a1 view taken
generally along line 5--5 in Fig. 3;
Fig. 6 is a transverse, sectional view taken
generally along line 6-6 in Fig. 3;
Fig. 7 is an enlarged, l.ongi.tudinally expanded or
exploded, longitudinal, sectional view of component parts of
6b
20543~G
the adapter taken generally along line 7-7 in Fig. 3 with the
component parts in the disassembled position, which component
parts are movable axially in a step-by-step action from the
disassembled position in Fig. 7, through the "Free Spin"
position (or intermediate position) in Fig. 12, to the
assembled, and catheter gripping position in Fig. 13:
Fig. 8 is an enlarged, fragmentary, cross-sectional
view (within the dashed line circles, as connected by the line
and arrow) of a portion of the compression member in the upper
portion of the adapter in Fig. 7;
Fig. 9 is a longitudinal, sectional view of an
axially shorter compression gland interchangeable with the
axially longer, corresponding compression gland shown in the
mid-portion of Fig. 7
Fig. 10 is an enlarged, fragmentary, cross-sectional
view (within the dashed line circles, as connected by the line
and arrow) of a portion of the body member in the lower portion
of the adapter in Fig. 7;
Fig. 11 is a top, plan view of the adapter for a
catheter introducer in Fig. 7, and especially of its
compression member in the upper portion of the adapter in Fig.
7;
Fig. 12 is a longitudinal, sectional view taken
generally along line 12-12 in Fig. 11 of the adapter for a
catheter introducer with its component parts in the "Free Spin"
position, or intermediate position;
_
2054396
Fig. 13 is a longitudinal, sectional view taken
generally along line 13-13 in Fig. 11, and taken in the plane
of the drawing in Fig. 2, of the catheter introduces, and its
adapter, with its component parts in the assembled, and
catheter gripping, position; and
Fig. 14 is a transverse, sectional view taken
generally along line 14-14 in Fig. 13 of the catheter showing a
lumen therein for transmitting waveforms.
DESCRIPTION OF THE PREFERRED EMBODIMENTS)
Figs. 2-14 disclose catheter introduces 31, and its
component adapter 32, of the present invention for catheter 34
having at least one lumen 35.
In Fig. 7, adapter 32 comprises the following three
mating parts, which have been shown assembled in Figs. 2 and
13:
(1) hemostasis valve assembly 38 in the lower part
of Fig. 7, including body member 40, sealing washer 42 and
duckbill valve 44;
(2) compression member 46 in the upper part of Fig.
7; and
(3) campression gland 48 in the central part of Fig.
7.
Introduces 31 in Figs. 2, 3 and 13 comprises not only
aforementioned adapter 32 but also: (1) transition member 52
with sheath 54; and (2) side arm 56, female luer adapter 58,
and male luer cap 60.
_ g -
2054396
Body member 40 (sometimes called hemovalve body or
hemovalve body member 40) in Figs. 7 and 10 includes separate
upper body member element 62and lower body member element 64 to
facilitate assembly of body member 40. After assembly, the
two, spaced apart, separate body member elements 62, 64 are
welded and secured together all around by circumferential,
sonic weld 66. Body member 40: (1) has in its lower element
64, annular shoulders 68 and 70; and (2) has in its upper
element 62: (a) annular flange 72 in its lower portions and
(b) in its upper portion, external threads 74, annular bore lip
76, stop shoulder 78, and internal cavity 80 having opening 82,
so body member 40 is sometimes called a hollow member.
During assembly of body member 40 and compression
member 46, these members sequentially move axially toward each
other from the expanded, disassembled position in Fig. 7,
through the intermediate position in Fig. 12, into the
assembled, or catheter gripping, position in Fig. 13.
During this assembly, compression member 46
(sometimes called cap, compression nut, or compression nut or
cap member 46) in the upper part of Fig. 7 has: (1) its
external annular rim or sleeve 84 over threads 74 and over
outer surface of body member 40; (2) its internal annular
flange or tubular plunger 86 having port 88, encircling
catheter 34, being aligned with cavity 80 of body member 40 for
a purpose to be described in more detail hereinafter, and
having its annular outer lip 90 snapping with a detent type
action axially past annular bore lip 76 of body member 40 into
the Fig 12 position; and (3) its internal threads 92 engaging
with external threads 74 on body member 40 in order to adjust
compression member 46 relative to body member 40 from the Fig.
_ g _
2o~~3oG
12 position into the Fig. 13 position, determined by its stop
shoulder 94 engaging against stop shoulder 78 on body member
40.
Body member 40 in the lower part of Fig. 7 has: (1)
a hemostasis valve, here elastic duckbill valve 44, in
communication with cavity 80 and having its outer annular
flange 96 resting on annular shoulder 70 of body member 40;
(2) sealing washer 42, preferably a latex washer, located in
flow communication with cavity 80 and against valve 44, and
having its central opening 98: located intermediate valve 44
and annular flange 72, receiving catheter 34, and sealing
against the outer surface of catheter 34, since opening 98 is
smaller than the outside diameter of catheter 34; and (3)
shelves or annular flanges 70 and 72, and two annular
projections 73 on the bottom of flange 72 (each triangular in
cross section) for engaging washer 42, for retaining valve 44
and washer 42 in place between body elements 62 and 64.
Duckbill valve 44 has single slit 100: (1) adjacent the lower,
distal, end of cavity 80 in Fig. 7 in fluid communication with
cavity 80; (2) permitting passage of catheter 34 therethrough
and sealing against the outer surface of catheter 34; and (3)
if catheter 34 has been removed, preventing passage of blood or
air through closed valve 44.
In Figs. 7, 9 and 13, elastic, cylindrical,
compression gland 48, an elastomeric means or gland, operates
in conjunction with, and between, body member 40 and
compression member 46; is located in cavity 80; rests on top of
annular flange 72, serving as a floor for gland 48: and may be
made of any suitable elastic material, such as silicone,
natural rubber or a thermoplastic elastomer, but has been made
-10 -
2054396
herein as a silicone elastomeric gland 48 with a 40 shore A
(durometer hardness). Two different sized glands 48 are shown
in Figs. 7 and 9 as glands 48a and 48b, each usable in adapter
32; but with only gland 48a shown as aligned for assembly in
Fig. 7.
In use, catheter 34 passes through bore 49 of gland
48, opening 98 of washer 42, and slit 100 of valve 44, with
washer 42 sealing against the outer surface of catheter 34.
Transition member 52 in Fig. 13 has: (1) its upper
end 102 fixedly secured at annular shoulder 68 to the lower end
of body member 40; (2) flow passageway 104 extending
therethrough; (3) elongated sheath 54 fixedly secured in its
lower end by tapered portion 105 at its upper end; (4) suture
eye 108 for detachably securing introducer 31 to the patient;
and (5) downwardly extending in Fig. 13 tapered portion 106,
flange 107, and lower distal portion 110, having helical grove
114 in its outer surface surrounding sheath 54, to provide
strain relief for sheath 54 and to reduce the possibility of
kinking of sheath 54 during use, and especially if bending
occurs when there is no catheter extending through sheath 54.
Introducer 31 in Figs. 2, 3 and 13 has elongated
sidearm or conduit 56 secured to side port 116 of transition
member 52 with its lumen 118: (1) at one end being in fluid
communication with bore 104 of transition member 52, and (2) at
its other end with any desirable components, such as female
luer adapter 58 having opposite ends telescoped into male luer
cap 60 and lumen 118.
-11 -
~05439~
In the upper part of Fig. 13, covering member 12o for
catheter 34 has elongated, flexible sleeve 122 attached by
O-ring 125 to annular flange 126 of connection member 128.
Connection member 128 has internal threads 130 screwing onto
thread segments 132 on compression member 46 in Fig. 11 for
releasably locking connection member 128 onto the upper end of
compression member 46 for preventing sleeve 122 from being
inadvertently removed form compression member 46.
Using introducer 31 involves these steps. First, an
intravenous catheter and needle assembly, with the needle
located inside the catheter, is inserted into a suitable vein,
usually located in the patient's neck area and going directly
to the heart, such as the internal or externaljugular vein,
subclavin vein, etc. After insertion into the vein, the needle
is removed from the catheter. Next, a guide wire is inserted
through the catheter until it is located in the vein, and the
catheter is removed over the guide wire. Next, a dilator,
having a channel extending therethrough, is passed through
introducer 31t into its sheath 54: and over the guide wire
until sheath 54 is located in the vein. At this time, the
dilator and guide wire are removed from introducer 31, with
sheath 54 in place in the vein. Sidearm 56 and sheath 54 may
be flushed, either at this time or before placing sheath 54 in
the vein.
Catheter 34 may be passed through introducer 31 and
sheath 54, either before or after attachment of covering member
120 to compression member 46. Inserted catheter 34 extends
through compression member 46, bore 49 of gland 48, body member
40 and sheath 54 into the vein. After covering member 120 is
telescoped over catheter 34 and is locked in place, flexible
-12 -
2054396
sleeve 122 extends over, and protects, catheter 34 during use
of introduces 31.
Catheter introduces 31 and catheter 34 may be of may
different types, but here are preferred types for this usage.
Introduces 31 is a percutaneous catheter introduces, here a
pulmonary catheter introduces. Catheter 34, here a pulmonary
arterial catheter 34 (for example, a PAC catheter, or a
Swan-Ganz catheter) is passed through introduces 31.
Catheter 34 may be used to infuse drugs into the
venous system during use of introduces 31. Drugs may be
infused from luer fitting 58 in Fig. 2 through lumen 118 in
Fig. 13 of sidearm 56, channel 104, slight clearance 134
between the outside of catheter 34 and the bore of sheath 54,
past catheter 34, and through sheath 54 into the patient's vein
in order to feed a solution, such as heparin, into the vein to
prevent blood clotting.
In Fig. 13, catheter 34 passes through central
opening 98 in washer 42 and through duckbill type, hemostasis
valve 44, where washer 42 seals against catheter 34 for
preventing passage of air into sheath 54, and preventing
passage of blood out through valve 44. With catheter 34 in
place in introduces 31, compression member 46 may be adjusted
relative to body member 40 (by having threads 74, 92 moving
members 40, 46 axially closer together from the Fig. 12 to Fig.
13 positions upon relative rotation of members 40, 46) for
applying pressure by internal tubular plunger 86 against gland
48 to bulge bore 49 of gland 48 inwardly for immobilizing and
holding catheters 34 in place in introduces 31, as shown in
Fig. 13.
-13 -
20~439G
Now, as to the mode of operation, introduces 31 has
been inserted into the patient; and catheter 34 has been
inserted into introduces 31, and slid through the vein, usually
into the right atrium or right ventricle of the heart. Then, a
balloon on catheter 34 is blown up, after it has been put into
the pulmonary artery of the patient. The balloon wedges into
the pulmonary artery; occludes the blood flow from the right
side to the left side of the heart; and during this seclusion,
allows medical personnel to monitor the heart, such as getting
a feeling for what the left side of the heart is doing, such as
measuring the pressures in the left side of the heart through
lumen 35 in Figs. 13 and 14.
Although five lumens are shown in catheter 34 in Fig.
14, and could be used and discussed, only one lumen 35 is
described herein for purposes of illustration and explanation.
The hydraulic pressure through lumen 35 from the heart can be
measured by a transducer, located outside the patient, to
monitor the heart waveforms. Catheter 34 may contain
additional lumens, as shown in Fig. 14, for other purposes.
For example, some of these lumens may be used for blowing up
the aforementioned balloon on catheter 34. Also, some of these
other lumens may be used for a purpose wherein overly
compressing the lumen prevents it from functioning properly, so
the advantages of coupling 35 may also be used for it. The
description hereafter herein will be restricted to only one
lumen 35.
When catheter 34 is sitting in the heart, it is used
to monitor the waveforms for the heart. Different conditions
of different heart portions have different waveforms.
Squeezing catheters 34 can distort: (1) lumen 35, (2) the
-14 -
2054396
waveforms received from the heart and transmitted through lumen
35, and (3) the medical data received and to be relied upon for
diagnosis and treatment.
Adapter 32 for catheter introducer 31 includes
coupling means 95 for carefully handling catheter 34 when
catheter 34 has at least one lumen 35 in Fig. 14 for
transmitting any waveform from the heart. Coupling means 95
[responsive to bringing together (by relative approach
movement) members 40 and 46, and connecting members 40 and 46
together] compresses compression gland 48, and closes its gland
bore 49, inwardly against catheter 34 by plunger 86 in a
cantrolled manner in the catheter gripping position in Fig. 13
by the relative approach movement of tubular plunger 86 into
cavity 80, so that: (1) maximum resistance to catheter 34
pull-out is provided without distorting any waveform
transmitted by lumen 35, and (2) neither catheter 34 nor any
lumen 35 is adversely crushed. Coupling means 95 includes:
(1) adjusting means for adjusting the relative position of the
members into said gripping position, comprising cooperating
threads 74, 92 respectively on body member 40 and compression
member 46: and (2) abutting stops 39 in Figs. 7 and 13 on
members 40, 46 determining said gripping position, with
abutting stops 39 including engaging or abutting: (a) stop
shoulders 78, 94 respectively on members 40, 46 determining
said gripping position, and (b) threads 74, 92 ending in thread
run out determining said gripping position. These abutting
stops 39 not only determine said gripping position but also
coact together to provide a double positive stop.
As to threads 74 and 92 ending in thread run out,
thread run out is defined as one or both threads coming to an
-15 -
2054396
end, so that members 40 and 46 will be abruptly stopped thereby
and cannot be screwed, relatively rotated, or axially advanced
any farther in the thread advancing direction.
Once catheter 34 has been placed into the patient, it
needs to be stabilized, so it doesn't become pulled out. This
is done by tightening down on compression nut member 46 of
adapter 32 until stop shoulders 78, 94 engage or abut, as shown
in Fig. 13. Engaging stop shoulders 78, 94 insure not only
that maximum resistance prevents catheter 34 being pulled out
of the patient but also that catheter 34 is not crushed to
adversely effect measurement through its lumen 35 of the
pressures for the left side of the heart.
Catheter 34 is able not only to be passed into the
heart into a monitoring position for heart monitoring purposes
but also to be pulled out of the heart into a retracted
position, such as at a time when heart monitoring is not
required or desired. When catheter 34 is to be repositioned,
compression member 46 is unscrewed by threads 74 and 92; bore
49 of gland 48 loosens its hold on catheter 34, so that gland
48 and sealing washer 42, located inside adapter 32, then allow
axial movement of catheter 34 inside body member 40 into the
retracted position without letting air enter or blood escape
out; catheter 34 is repositioned axially in body member 40; and
compression member 46 is tightened until stop shoulders 78, 94
reengage, so as to hold catheter 34 in the retracted position.
After monitoring the heart is finished, the balloon is
deflated. Thereafter, the deflated balloon and catheter 34 are
pulled back from this monitoring or active position into this
retracted or inactive position.
-16 -
205496
Now, passage of blood or air through valve 44 is
still prevented, because sealing washer 42 opening 98 seals
against the outer surface of catheter 34.
Catheter 34 may be removed from adapter 32 by
following the catheter repositioning steps given above. If
catheter 34 has been removed, passage of blood or air is
prevented by the automatic closing of valve 44 after catheter
34 was removed.
Here is one suitable method of manufacturing
introducer 31. Compression member 46 is formed of a rigid
material, such as nylon. Body member 40 and preformed sheath
54 (each formed of a suitable material, such as urethane) are
placed in a spaced relationship in a mold. Next, transition
member 52 is injection molded in the mold from a suitable
material, such as urethane, in order to form an integral,
sealed construction of sheath 54 and body member 40, as shown
in Figs. 3 and 13, such that body member 40, transition member
52 and sheath 54 are integrally formed into one piece in a
manner preventing leakage of air or blood through the bonds of
the various component pieces, and are interlocked against
separation by shoulder 68 on body member 40 and tapered portion
105 on the upper end of sheath 54.
Compression gland 48 is precisely dimensioned, and
its sizing and use are carefully controlled.
Here is a method used for sizing gland 48, while
gland 48 is located in cavity 80 and compressed against
catheter 34 by compression member 46 moved toward gland 48.
This method includes the steps of: (1) inserting gland 48 into
-17 -
~0~4396
cavity 80; (2) moving compression member 46 toward cavity 80,
gland 48 and body member 40 to the catheter 34 gripping and
member stopping position in Fig. 13 with stop shoulders 78, 94
engaged; (3) measuring the compressive force on catheter 34:
and (4) correcting the size of gland 48, so that a preselected
compressive force is not exceeded.
In this method, this measuring may take either of
these two different methods: (1) if catheter 34 has at least
one lumen 35, this measuring involves measuring the distortion
of the waveforms transmitted by lumen 35, so as not to exceed
the compressive force giving the preselected maximum waveform
distortion: or (2) this measuring involves measuring the
pull-out force on catheter 34, so that the compressive force is
sufficient to prevent catheter 34 pull-out but not large enough
to distort any waveform transmitted by lumen 35. Since the
goal is to eliminate, or at least to minimize, any distortion
of any waveform transmitted by lumen 35, measuring the
distortion of the waveforms transmitted by lumen 35 in (1) is
the preferred measurement here of the compressive force exerted
on catheter 34 by gland 48. This pull-out force measurement in
(2) could also be used to substantiate the measurement in (1)
obtained by the distortion of any waveform transmitted by lumen
35.
If two, different sized, interchangeable glands 48,
shown in Figs. 7 and 9 as glands 48a and 48b respectively, were
sized and used for corresponding catheters 34 having at least
two different sized outside dimensions, the sizing and use of
glands 48 would involve further the method steps of : (1)
separately sizing these two different sized glands 48a and 48b,
each by one of the methods in the preceding paragraph for its
-18 -
2054396
corresponding catheter 34; and (2) for the different sized
catheters 34, interchanging glands 48a and 48b being used with
the corresponding sized catheter 34.
Each compression gland 48 is precisely dimensioned to
ensure that when compression member 46 is positively stopped by
engagement of stop shoulders 78 and 94, the maximum resistance
to catheter 34 pull-out in the catheter gripping position is
achieved without distortion of any waveform transmitted by
lumen 35 in catheter 34.
Consider this method by a different approach. Then,
the volume for compressing any gland 48 in the catheter
gripping position in Fig. 13 is a function of the location of
stop shoulders 78, 94; the inside dimensions of cavity 80 (as
bounded by flanges 72 and 86), and the following volumetric
ration defined by the ratio of:
the volume of the compressed gland 48
in the catheter gripping position in Fig 13
to
the volume around catheter 34 in its
surrounding cavity 80 (bounded by annular
flanges72 and 86, and determined by engaged
stop shoulders 78 and 94) in the catheter
gripping position
defines a volumetric ratio, providing maximum resistance to
catheter pull-out without adversely crushing catheter 34 or
distoritng any waveform transmitted by lumen 35 in catheter 34.
For two, different sized, interchangeable glands 48a and 48b
usable with catheters 34 having at least two different sized
outside dimensions, the volumetric ration for a compressed
gland in the catheter gripping position being substantially the
-19 -
~o5~~9s
same for both glands 48a and 48b as long as the following
factors remain constant, and do not vary or change: (1) lumen
35, or any other effected lumen(s), in catheter 34, and (2) the
characteristics of the gland material, such as its durometer
hardness.
Here are some examples. Since different size (in
outside diameter) catheters) may be used in an adapter, such
as adapter 32, different size compression glands 48, such as
gland 48a and 48b in Figs. 7 and 9 respectively, are used
interchangeably in cavity 80 of body member 40. Four different
sized catheters 34 are commonly used, i.e., catheters Nos. 7.5,
7, 6 and 5 French respectively having outside diameters
approximately 0.099, 0.092, 0.079 and 0.066 inch and using
sheaths 8 1/2, 8, 7 and 6 French. There is an advantage in
having each gland 48 use the same inside diameter bore 49 and
outside diameter periphery 50; and being cylindrical, or
annular, with the same cross sectional shape in Figs. 7 and 9,
since glands 48 can then be made by an extrusion process and
can be easily cut into different lengths from the same
extrusion. Two annular, elastomeric, compression glands 48a
and 48b, having the same outside diameters and inside diameters
(each having bore 49 of approximately the same cross sectional
dimension telescoped over its catheter 34), may be used for all
four sizes of catheters 34 if each compression gland 48 is
formed, or cut, in two different axial lengths, such as axially
shorter gland 48b in Fig. 9 for the two larger outside diameter
catheters, and axially longer gland 48a in Fig. 7 for the two
smaller outside diameter catheters. The proper length of each
gland 48 has been determined experimentally by some of the
aforementioned methods, and this experiment: inserting a gland
48 (over catheter 34 of desired outside diameter size) into
-20 -
2o~43ss
cavity 80 of body member 40, moving members 40 and 46 to the
Fig. 13 assembled, or catheter gripping, position with engaged
abutting stops 39 (including stop. shoulders 78 and 94 fully
engaged and threads 74, 92 ending in thread run out), and
measuring the distortion of the waveforms transmitted by lumen
35. Repeating this experiment with different (outside
diameter) sized catheters 34 and different length glands 48,
measuring the distortion of the waveforms transmitted by lumen
35, and graphing the results will reveal the proper length
glands 48 to use for each size catheter 34. Wave distortion
should be reduced by cutting down the length of its gland 48.
If each cylindrical compression gland 48 has an inside diameter
of approximately 0.127 inch and an outside diameter of
approximately 0.285 inch, the, shorter gland should be
approximately 0.179 inch long and the longer gland should be
approximately 0.191 inch long when the inside diameter of
cavity 80 is approximately 0.299 inch for handling the four
different sized catheters mentioned above.
The mode of operation is further described hereafter
in detail. Numerous advantages are disclosed hereafter by
slowly and carefully considering: (1) the step-by-step action
of moving the component parts from the disassembled position in
Fig. 7, through the "Free Spin" position in Fig. 12, to the
assembled (or catheter gripping) position in Fig. 131 and (2)
the structure and coaction of the component parts, and the use
advantages obtained:
-21 -
2U54396
STEP NO. 1' PUSHING GLAND 48a OR 48b RESPECTIVELY IN
FIG 7 OR FIG 9 AXIALLY INTO OPENING 82. PAST ANNULAR BORE LIP
76 AND INTO CAVITY 80 OF BODY MEMBER 40: The same snap past,
or detent, action is provided for detachably holding any gland
48 in cavity 80 by bore lip 76, because each elastomeric gland
48 has an outside diameter dimension of its periphery 50
greater than the internal diameter dimension of bore lip 76 and
fitting into the internal diameter dimension of cavity 80, so
that gland 48 can be pushed and telescoped through mouth 82
into cavity 80 and detachably held in cavity 80 by bore lip 76,
unless a significant axial, separating, pulling apart or
disassembling force is exerted.
If different sized glands 48 are to be used
interchangeably (as described in the preceding paragraph for
different sized catheters and as illustrated in Figs. 7 and 9),
each of the different sized glands 48 will be detachably held
in the same manner in cavity 80 by bore lip 76. Then, two
elastomeric glands 48, each gland 48a and 48b of a different
length, has approximately the same outside diameter dimension
for fitting interchangeably in cavity 80 and for being held by
same bore lip 76, so that gland 48a and 48b can be used
interchangeably, each with a different outside dimensioned
catheter 34 gripped by the compression of a different length
gland 48.
STEP NO. 2' ANNULAR SLEEVE 84 ON COMPRESSION MEMBER
46 KEEPS THE PARTS COAXIALLY ALIGNED: Annular sleeve 84 of
compression member 46 is coaxial with, and closely surrounds
the periphery of, body member 40 and its threads 74, so helps
keep members 40 and 46 coaxially aligned, and easily rotatable:
-22 -
2054396
(1) in all positions, between and including Figs. 7,
12 and 13 positions, and
(2) in step Nos. 3, 4 and 5 described hereinafter,
since this coaxial alignment prevents cocking, binding and
misalignment of members 40 and 46, etc. The bore of sleeve
portion 84 on one member 46 coaxially extends in close
transverse alignment with, and surrounding, portions of a
cylindrical surface on other member 40 (with these portions of
a cylindrical surface being formed by crests of external
threads 74 on other member 40 before engagement of threads 74,
92) for guiding members 40, 46 into coaxial alignment: (1)
with threads 74, 92 aligned for engagement; (2) with no cocking
of the component parts; and (3) for promoting free spin and
rotational actions, as well as axial pushing, pulling and
movement actions.
STEP NO. 3' PUSHING ANNULAR OUTER LIP 90 ON
COMPRESSION MEMBER 46 AXIALLY INTO OPENING 82 PAST ANNULAR_
BORE LIP 76 AND INTO CAVITY 80 OF BODY MEMBER 40 INTO THE FIG.
12 POSITION "SNAPS" MEMBERS 40,_46 TOGETHER: Body member 40
has its cavity 80, and its mouth 82, aligned with, and to
receive, tubular plunger 86 on compression member 46. Bore lip
76 at mouth 82 has an internal diameter dimension less than the
internal diameter dimension of cavity 80, and of outer lip 90
on the periphery of tubular plunger 86 on its end closest to
cavity 80. As outer lip 90 moves axially past bore lip 76 into
cavity 80, members 40 and 46 are detachably connected together
by a "snap action".
During packaging, shipping and use of adapter 32,
engaged annular lips 76, 90 help: (a) retain the component
parts in properly assembled relationship, (b) prevent
-23 -
X054396
disassembly and loss of component parts, and (c) maintain
sterilization of some component parts and surfaces, especially
those within adapter 32 close to catheter 34. The component
parts will disassemble only if a substantial axial, separating
force is exerted to pull apart members 40, 46 and annular lips
76, 90 by a "snap action".
STEP NO. 4' RELATIVELY ROTATING COMPRESSION MEMBER
46 ON BODY MEMBER 40 BY A "FREE SPIN" ACTION IN THE FIG. 12
POSITION: Each of lips 76 and 90, and cavity 80, are coaxial
and annular in shape, so that members 40, 46 have a free spin,
coaxial, rotational action without cocking or binding the
component parts, even though the members are only detachably
connected.
During packaging, shipping and use of adapter 32,
accidental or unauthorized disassembly of adapter 32 is
resisted in the Fig. 12 position, since this Fig. 12 position
provides a "free-spin" relative rotational action between
members 40 and 46; since neither threads 74, 92 nor stop
shoulders 78, 94 are engaged: and since annular sleeve 84 of
compression member 46 is coaxial with, and closely surround the
periphery of, body member 40 and its threads 74 to help keep
members 40 and 46 coaxially aligned during this "free-spin"
action.
Since this free spin, coaxial, rotational action
occurs before engagement of threads 74 and 92, this action
guides members 40 and 46 into coaxial alignment with the
threads aligned for engagement thereafter in the next step No.
5, and without cocking or binding of the component parts.
-24 -
~05439G
STEP NO. 5: AXIALLY PUSHING TOGETHER MEMBERS 40 AND
46 TOWARD EACH OTHER AND RELATIVELY ROTATING MEMBERS 40 AND 46
IN THE THREAD ADVANCING DIRECTION' ~A) UNTIL THREADS 74 AND 92
ENGAGE ON RESPECTIVE MEMBERS 40 AND 46 AND (B) ADVANCING
MEMBERS 40 AND 46 TOWARD EACH OTHER iLTOWARD THE FIG. 13
POSITION) BY THE THREAD ADVANCING ACTION OF COMPATIBLE THREADS
74 AND 92: Although threads 74 and 92, and stop shoulders 78
and 94 may take any suitable form or location, each of the
threads 74 and 92 herein uses a 3/4 turn, 20 pitch, single lead
threads 74, 92 ending in thread run out as, and when, stop
shoulders 78 and 94 engage or abut providing not only four
abutting stops 39 but also a double positive stop determining
catheter 34 gripping position. This 3/4 thread turn makes for
a very fast movement from Fig. 12 to Fig. 13 positions,
requiring only a 3/4 relative turn by members 40 and 46, and
having a 3/4 pitch axial thread length of about 0.0375 inch
X3/4 x 1/29).
STEP NO. 6' ENGAGING STOP SHOULDERS 78 AND 94 ON
RESPECTIVE MEMBER 40 AND 46: Gland 48 is compressed inwardly
to grip, and hold, catheter 34 by its gland bore 49 in the Fig.
13 position, after which stop shoulders 78 and 94 engage to
stop further rotation of members 40 and 46, and further
compression of gland 48, so as to prevent adversely crushing
catheter 34, and its lumen 35.
When the Fig. 13 position is reached as stop
shoulders 78 and 94 abut, a jamming, or lock-up, action occurs
to lock members 40, 46 more firmly together in the Fig. 13
position then would have been otherwise expected, since threads
74, 92 end in thread run out as stop shoulders 78, 94 engage,
and threads 74, 92 jam and lock up for securing members 40, 46
-25 -
205396
together in the catheter 34 gripping position in Fig. 13. This
action is similar to a lock washer action on a tightened screw
and nut. It provides the advantages of the lock washer without
the disadvantages of a separate lock washer part, which would
have surface difficult to keep clean.
All of the advantages described herein, and in these
Steps No. 1-6 inclusive, are obtained efficiently with minimum
effort and mavement, because: (1) only a minimum compression
of gland 48 is required since the outside diameter of gland 48
is only slightly smaller than the diameter of the bore of
cavity 80 behind its bore lip 76; (2) only a minimum difference
exists between the internal, diametrical dimensions of bore lip
76 and cavity 80, so that only minimum relative approach
movement of members 40, 46 is required for compressing gland 48
and for movement into the catheter gripping position; and (3)
since only minimum relative approach movement of member 40, 46
is required, each of the threads 74 arid 92 need not be
substantially mope than a 3/4 pitch axial thread length.
It should now be apparent that: (1) Adapter 32 is
easy to use, in view of its many features described herein; (2)
Each compression gland 48 is precisely dimensioned to ensure
that when compression member 46 is positively stopped by
engagement of stop shoulders 78 and 94, the maximum resistance
to catheter 34 pull out in the catheter gripping position is
achieved without distortion of any wave form transmitted by
lumen 35 in catheter 34; (3) Glands 48 are interchangeable, and
are easily made by cutting an extrusion into proper length(s);
and (4) Using adapter 32 eliminates the problems encountered in
the prior art, and takes the "guess work" out of this operation
of providing maximum resistance to catheter 34 pull-out in the
-26 -
2054396
catheter gripping position without distortion of any waveform
transmitted by lumen 35 in catheter 34.
This invention may be: embodied in other specific
forms without departing from the spirit or essential
characteristics thereof. It is understood that: the present
embodiments) are therefore to be considered in all respect as
illustrative and to restrictive, the words which have been used
are words of description rather than words of limitation, the
scope of the invention is indicated by the appended claims(s)
rather than by the foregoing description, and all changes which
come within the meaning and range of equivalency of the
claims) are therefore intended to be embraced therein.
While the foregoing detailed description has been
directed to the use of heart catheters for monitoring the heart
function by transmitting its waveforms, it will be appreciated
that the invention is not restricted thereto and that the
transmission of other mediums are also contemplated.
For example, a heart catheter may be employed for
transmitting such mediums as diastolic and systolic pressure
readings, taking blood samples, introducing medicaments such as
antibiotics, anticoagulants, monoclonal antibodies for
bioassays, and the like.
It is also visualized that the invention may be
utilized with catheters other than heart catheters, e.g. for
such healthcare functions as IV therapy, parenteral feeding and
the like.
-27 -
Since certain changes may be made without departing
from the scope of the invention herein contemplated, it is
intended that all matter in the foregoing specification and
drawings shall be taken as illustrative and not in a limiting
sense.
-28 -
