Note: Descriptions are shown in the official language in which they were submitted.
10'~
This invention relates to a device for the insertion
of a catheter into the vascular system of a patient, and more
particularly to such devices of the type which employ a needle
secured to a dispenser having a rotatable catheter receptacle to
forward the catheter through the needle.
Although dispensing devices employing a rotating recep-
tacle action similar to that disclosed in this application have
been known in the prior art (e.g., U.S. Patents 2,685,097 and
3,561,445), no device known to applicants has achieved the superior
results flowing from the novel combination disclosed herein.
The advantages of the device disclosed herein are most
marked with regard to applications in which relatively long catheters
are required. An example of such a situation is the introduction of
a catheter to forward the distal end thereof to the central veins
of the chest. Through an entry made in the peripheral vessels,
such as those in the arm. Such an application may require as much
as twenty-four inch catheter length. The utilization of the device
disclosed~herein represents a significant stride forward in the
emplacing of such catheters. The device may also be used with
medium length and long catheters smaller than twenty-four inches,
particularly those over about eight inches.
The device disclosed herein is particularly advantageous
in connection with the incorporation of catheters formed from sili-
cone elastomer tubing, although the invention is not limited to the
use of such tubing. The desirable properties of silicone elastomer
tubing for use in catheters for intravenous infusion of fluids or
other medical applications have been known for over twenty-five
years. The materials from which tubing of this type are fabricated,
for example, a silicone elastomer marketed under the trademark
"SILASTIC", are marked by a high degree of body compatibility
compared to other materials from which catheters have been and are
~ormed, such as polyethylene, "Teflon*", and vinyl. The silicone
- 2 - ~
9~ ~
elastomers are relatively inert to organic tissues and fluids,
non-clotting as to the blood and are highly flexible so as to
reduce the trauma involved in their insertion and maintenance in
the body. It is possible to maintain a silicone elastomer catheter
implanted in the body for a longer period of time than with other
types of tubing. The necessity for frequent removal reintroduction
of catheters is a marked disadvantage in almost any medical applica-
tion.
One particular difficulty experienced in the past with
respect to inserting and forwarding relatively long silicone
elastomer catheters has been the difficulty in providing sufficient
stiffness and control over the catheter during forwarding while
avoiding the dangers of piercing the catheter or causing undue
trauma to thepatient's system. The device disclosed herein incor-
porates a stiffening mechanism ana a feed guide which cooperate
with the catheter and the dispensing apparatus to give good control
over forwarding of the silicone elastomer catheter while minimizing
the dangers of piercing and trauma. It is particularly advantageous
in exceptionally long catheter applications, since the stiffener
and controlled dispensing apparatus cooperate to effectively forward
the catheter, even in instances where the path for the catheter
provides resistance. The forwarding action of
* denotes trade mark
10'~914~ I
B2883 the dispenser appears to cause the stiffener to slide out
through the distal end of the silicone elastomer catheter and
gulde the catheter forward. The stiffener may be wlthdrawn
smoothly after insertion because of the cooperation between the
helical stiffener employed and the silicone elastomer catheter.
One dan~er which is present in-some needle devices
, for inserting a delicate silicone elastomer catheter is that
of shearing of the catheter by the beveled end of the needle.
. This danger is marked when a silicone elastomer catheter is
1 implaced by being wholly contained within and surrounded by a
full hollow needle.
1 With respect to devices which have utilized slotted
i needles for the insertion of catheters~ it has in the past
I frequently been felt necessary to make provision for locking
of the catheter assembly with respect to the slotted needle
' so that the catheter does not move in the slotted needle
¦ after venous puncture,since movement could result in excessive
¦~ loss of blood. The utilization of the device disclosed herein
I obviates the need for distinct mechanisms which must be
2~ ~ locked or unlocked, since the dispenser associated with the
I slotted needle in the present device automatically acts to
,.
I frictionally resist such movement.
!' Experimental use of devices in accordance with
j disclosures of this application has indicated that it is
, possible to implant catheters up to twenty-four inches in
¦ length and perhaps more, and leave them in place for relatively
~. , .
I -4-
I'
1,1 10'791~ 1
2883 I long periods of time, six weeks for example. The catheter
and slotted needle maintain their proper position prior to
! and during insertion without the necessity of additional
Il locking and unlocking mechanisms. The forwarding mechanism
¦1 in cooperation with the stiffener and elastomeric catheter
¦¦ gives excellent control to optimize the insertion and
¦ forwarding process. The dangers of catheter shearing or
¦ puncture and patient trauma are reduced.
¦ The guide provided inside the dispenser permits
! even forwarding of the catheter and reduces the chance of
¦ binding or kinking of the catheter or stiffener. The guide
cooperates with a stop on the dispenser to prevent deforma-
tion of the catheter by preventing rotation of ~he dispenser
¦~ past the point at which the end of the catheter is adjacent
I the outlet on the last turn of the catheter.
I The dispenser may be guickly and easily disassembled
¦ to remove the needle from the patient after catheter insertion.
The catheter insertion device disclosed herein
! includes a catheter dispenser which has a catheter receptacle
¦¦ formed by an inwardly-facing wall for receiving a catheter
1~ therewithin. The dispenser has a catheter outlet and means
¦¦ for rotating the circumferential wall with respect to the
li outlet. A needle having a pointed distal ena and proximal
¦l end secured to the dispenser outlet is provided. A catheter
~ is wound in the receptacle inside the inwardly-~acing wall
!~ Of the dispenser, the catheter extending through the dispenser
outlet with its distal portion lying in the needle. A
!1 -
I -5- '
I
i,
il .
'' ' Ij . .
1 1~'7~
~ '
."
B2883 j stiffener extends through the catheter urging the catheter
Ij against the inwardly-facing wall of the catheter dispenser.
¦, Guide means are provided in the dispenser engaging a portion
j of the catheter near the dispenser outlet to guide the
~ catheter towards the outlet as the receptacle is rotated.
¦ The catheter dispenser may include a base having a
I slotted catheter outlet and a second member which forms the
¦ catheter receptacle, the dispenser including means which releas-
' ably engage these first and second members in rotating relation-
ll ship for movement of the catheter through the outlet.
In a preferred embodiment of the device, the dispenser
has a ~ase and receptacle which are rotatably secured by a
spindie extending upwardly from the base through an aperture in
I the top wall of the receptacle. The spindle is split into a
1i plurality of yieldable fingers having a circumferential detent
li bead to engage the receptacle. A release button rides atop the
j fingers, and may be depressed to urge the fingers together
¦ assisting in release of the receptacle. The utilization of such
i structure permits ready and smooth release of the receptacle from
I above the dispenser, without the necessity for manipulations
under the dispenser which might cause the needle in place to be
painfully raised during release.
i The guide means may be a flexible elongate mem~er ex-
tending along the walls of the receptacle between the portion of
~5 I the catheter closest to the dispenser outlet and successive turns
of the catheter. A shoulder stop may be provided to engage the
member to positively stop rotation of the receptacle at a
-6-
1 . .
., .
11)'7~ ~ff
'i
B2883 I predetermined point in the dispensing of the last turn of
!- the catheter.
il For a more complete understanding of the present
i! invention and for further objects and advantages thereof,
j reference may now be had to the following description taken
I in conjunct~on with the accompanying drawings, in which:
I
' ' ' -' ,.
, .
Il -7- -
,
,
10'791~ 1
.1, ' ' .
B2883 ~ FIGURE 1 is a perspective view of the catheter
insertion device constructed in accordance with the present
invention;
I FIGURE 2 is a vertical cross section taken along
5 i the line 2-2 in Figure 1 (with the proximal portion of the
ca~heter removed for simplicity~,
FIGURE 3 is a vertical cross section taken along
the line 3-3 in Figure 1 ~with the proximal portion of the
catheter removed for simplicity~;
I FIGVRE 4 is a top view of the base member of the
device shown in Figure 1 ~with the proximal portion of the
¦ catheter and release button removed for simplicity);
, F~GURE 5 is a perspective view of the bottom of
. , the base member shown in Figure 4;
j FIGURE 6 is a view similar to Figure 5, with the
base member shown prior to mounting of the flexible guide
¦ thereon;
¦ FIGURE 7 is a view similar to Figure 6, illustrating
an a~ternate embodiment of the means for securing ~he guide
to the base member;
FIGURE 8 is a perspective YieW of the top member
or receptacle of the device shown in Figure l;
I FIGURE 9 is a plan view of the receptacle shown in
¦i Figure 8;
' FIGURE 10 is a frasmented, partially cut-away vies~
' of the catheter, stiffener and catheter hub and plug used in
~ .
--8--
1~, . ',` .
1l 1079~4~3
B2883 ', the device illustrated in Figure 1, with those portions
j straightened out for ease of illustration;
FIGURE 11 is a partially cut-away plan view of
I the distal portion of the stiffener illustrated in Figure 10;
I FIGURE 12 is a sectional view of the proximal
portion of the stiffener with catheter plug illustrated in
Figure 10;
FIGURE 13 is a perspective view of the device of
Figure 1 with the wall of the receptacle partially cut away,
illustrating the device prior to utilization;
¦ FIGURE 14 is a perspective view similar to that of
¦ Figure 13, illustrating the device after the receptacle has
¦ been rotated to insert the catheter into the body of a patient;
I . FIGURE 15 is a perspective view illustrating the
step of removing the catheter receptacle after insertion has
. reached the stage illustrated in Figure 14; and
FIGURE 16 is a view showing the step of completing
the catheter insertion prior to removal of the needle.
The catheter insertion device illustrated includes
a catheter dispenser generally indicated by the reference
. numeral 10 secured to a slotted needle 12. Dispenser 10
. is formed by the releasable engagement of a catheter receptacle
14 and a base 16.
The catheter receptacle 14, which may be fabricated
~ as an integrally molded plastic member, comprises a cylinder
Il defined by a circumferential outer wall 18. A flat top wall 20
11,
1, _ 9 _
Il
. .. !l
791~8
,
.
B2883 , extends across one end of cylindrical wall 18. A central
, mounting aperture 22 is formed in top wall 20. In addition,
a pair of offset apertures 24 and 26 are provided in top
il wall 20. Receptacle 14 is provided with an inner cylindrical
~l wall 28 extending' axially from top wall 20, defining an
¦ annular space 30 between outer receptacle wall 18 and the .
! inner wall 2~. The thickness of wall 28 is increased at the top
¦ of space 30 to reduce the width of space 30 at its juncture
Il with top wall 20. The cylinder formed by wall 28 is not
jl complete, but is provided with a gap 32 which provides a means
for passage between the central area of receptacle 14
I encompassed by inner wall 28 and the annular space 30 through
.¦ which a catheter may be passed. A catheter hub restraining .
l! wall 34 extends raaially inwardly from inner wall 28 near
¦I the gap 32. A catheter hub restraining post 36, complementing
¦ wall 34, is spaced from wall 34 so that a catheter hub may
~ be placed between restraining wall 34 and post 36.
¦ At the lower end of receptacle 14, outer wall 18
! is provided with an outwardly turned bearing lip or flange -
2Q 1 38 for engagement with the base 16.
Base 16, which may likewise be fabricated as an
integrally molded plastic article, has as its major portion
!¦ a flat plate 40 in the shape of a circle. Plate 40 is
¦I provided with a circumferential,upper flange 42 and lower
!¦ flange 44 at the intersection of a cylinder 46 with the
1~ periphery of base plate 40.
il ~
Ii -10- ~ .
Ii ,
.
.. ,. ~ I
914~ !
i
I
B2~83 , Needle hub 50 is formed integrally on the outside
'', of cylinder 46, and is provided with a longitudinal slot 52
;; running the entire length of needle hub 50. Cylinder 46 has
., a catheter outlet slot 53 which communicates with the
longitudinal slot 52 of needle hub 50. In combination, the .
¦ needle hub slot 52 and outlet slot 53 provide a channel
communicating from the interior o~ base 16 encompassed by
cylinder 46 with the outer end of needle hub 50. Base plate
I¦ 40 is provided with a channel or guide depression 54 formPd
li circumferentially in its surface leading into outlet slot 53~
il Hollow slotted needle 12 is provided with a pointed
¦¦ distal tip 56 suitable for piercing and a longitudinal slot
~! 58 running its entire length. Needle 12 is secured to
¦I needle hub 50 so that needle slot 58 is registered with the
~5 I slot 52 of needle hub 50. Needle 12 may be secured to hub
1 50 by any convenient means; such as by molding or a tab-in-
¦l groove lock. There is thus provided a channel for moving a
¦ catheter from the interior of base 16 to the distal point 56
of needle 12, with a continuous slot providing access to that
~0 ll channel ~y the catheter outlet slot 53, needle hu~ slot 52
! and needle slot 58.
A mounting spindle 60 is formed integrally on the
'li central portion of base plate 40. Mounti~g spindle 60 extends
¦! axially up~ard from base plate 40 and its upper portion is
,~ trifurcated by longitudinally extending slots 62 to form
'' three yieldable spindle fingers 64 as the upper portion of
ij ` i
' ' . I
1, -11- 1
1~)'79~4~
spindle 60. A detent bead 65 is formed on spindle 60 circumferen-
tially around the fingers 64 near the top of spindle 60.
Spindle 60 cooperates with mounting aperture 22 on re-
ceptacle 18 to secure receptacle 18 to base 16 in rotating engage-
ment. Spindle 60 extends upwardly through the aperture 22 in top
wall 20 of receptacle 18 so that the detent bead 65 restrains top
wall 20 and the top end 68 of spindle 60 extends above the
receptacle 18. In this position, the receptacle mounting flange
38 slidingly confronts the periphery of plate 40 on base 16. So
mounted, the base 16 and receptacle 18 form the dispenser 10 and
the receptacle 18 may be rotated with respect to base 16.
Spindle 60 is hollow throughout its length and receives
a release button shaft 66 having a release button 67 formed
integrally at the top thereof. Release button 67 is secured in
position over the top of fingers 64, as illustrated in Figures 2
and 3. A mounting stop 68 formed on the bottom of shaft 66 as it
extends through base plate 40 prevents upward movement of shaft 66
within the spindle 60. Release button 67 has an inner frustoconical
surface 69. On depression of button 67, the surface 69 acts to
press the fingers 64 inwardly together to assist in disengaging
head 65 from receptacle 18.
Base 16 is provided with a guide mounting aperture 70
through the periphery of plate 40 near the catheter outlet slot 53.
Catheter guide means in the form of an elongate flexible guide rod
72 extends upwardly from plate 40 through aperture 70. Guide rod
or finger 72 may be in the form of a thin solid rod formed from
some relatively s~iff but still yieldable and
12 -
!
91~
!
B2883 flexible material such as polyethylene or nylon. The lower end
3 of guide 72 is flat so as to provide a convenient mounting plate !
1 74. As illustrated in Figures 5 and 6, the guide 72 may be
i~ secured to base 40 on the underside of base 40 by means of pegs
S l 76 integrally formed on the underside of base 40 adjacent the .
" aperture 70. Corresponding holes on the mounting plate 74 of
Il guide 72 are fitted over the mounting pegs 76 in assembly of
¦¦ the device, and then the pegs are subjected to melting action, as
' by ultrasonic means, to bond the mounting plate 74 in position on
¦~ the pegs 76. Alternatively, as illustrated in Figure 7, plastic
I! mounting ribs 78 may be formed on the underside of plate 40
¦i, forming a raised "U" which is open in the direction of aperture
' 70 In this embodiment, the guide mounting base 74 may be
,i placed against plate 40 surrounded by ribs 78, and the ribs sub- .
li ~ected to similar melting action to bond the base 74 and thus the
, guide 72 into position extending through aperture 70. The end of
¦ guide rod 72 opposite the mounting base 74 is a free end 7~.
¦ No special preset curvature is formed in rod 72, so
~ that prior to assembly in the device, it may extend linearly up
I and out from the aperture 70. The free end 79,when unrestrained,
jJ extends to ab~ut the height of the receptacle 14 and extends out-
!~ wardly of flange 46. When loaded into the assembled dispensert
¦~ with the receptacle lg in position on base 16, the guide 72 is
!` restrained in a circumferential path as shown in ~igure 4~
defined by the annular space 30 in receptacle 18. If desired,
t~ the guide could be precast to conform to such circumferential
path.
-13-
~, . I
~. I
` 1~'7~148
B2883 . A catheter 80 with interiorly disposed stiffener 82 is
wound inside receptacle 18 and extends outwardly througL outlet
slot 53 so that it lies in needle 12. The structure and arrange-
ment of the catheter 80 and stiffener 82 are illustrated in
- Figures 10-12. Catheter 80 is secured at its proximal end in a .
catheter hub 84 having wings 86 and providing a conventional
female Luer fitting 88 for connection of a fluid source to the
' catheter 80 through catheter hub 84. A Luer plug 90 is secured
. in fitting 88 to b~ock off the proximal end of th2 catheter hub 84
- Catheter 80 if formed from a silicone elastomer tubing such as
that marketed under the trademark "SILASTIC". The proximal end
of stiffener 82 is carried by plug ~0, and is secured thereto by
the wedging of expanded end 92 on stiffener 82 into the central
channel 94 provided in plug 90.
. Stiffener 82 is comprised of a closely-wound wire
helix 96 which surrounds a central strip of wire 98. The central
. strip 98 extends the entire length of stiffener 82. The central
stiffening strip 98 and helix 96 are secured at their distal end
l~ by welding ~t rounded distal tip 100. In addition to strip 98,
i a stiffer central core wire ~not shown~ may be utilized to gi~e
j additional stiffness, and typically would be extended from the
¦ proximal end of stiffener 82 at 92 to within about two inches
~ of the distal tip 100. The stif~ener 82 is one which has been
J used in the prior art as a ~uide in certain caraiovascular
j diagnostic procedures and in forwarding of subclavian silicone
j elastomer catheters. Its use in the envirol~ent of this
invention is not believed to have been previously known.
- -14-
i, l~'~gl~
I! . .
!~
B2~R3 Ij In the assembled device 10, the catheter 80,
! assembled with stiffener 82 as indicated in Figure 10, are
loaded inside the receptacle 14 of dispenser 10, with the
1. distal end of the catheter 80 and stiffener 82 extending
¦1 outwardly into needle 12. Catheter hub 84 is positioned in
l! the portion of receptacle 18 enclosed by inner wall 28, with
!I the hub 84 positioned between the wall 34 and post 36 as
Il indicated in Figure 9. Catheter 80 éxtehds from hub 84
¦, through the gap 32 in wall 28 into the annular space 30
, between inner wall 28 and outer wall 18. The catheter 80
j with its interiorly disposed stiffener 82 is wound in the
j annular space 30, with each successive turn coming closer to
¦ the base 16. Stiffener 82 causes the stiffened catheter to
! be urged outwardly against the inwardly-facing wall provided
lX 'i by outer cylinder 18~ The distal portion of catheter 80 is
¦I thre~ded out through guide depression 54 and slot 53 on base
16 so that it lies in the needle hub 52 and needle 12. The
¦ distal tip of catheter 80 preferably is located just at the
¦ beveled end of needle 12, and is maintained in that position
! hy the frictional engagement of receptacle wall 18 with the
catheter 80. The free end 79 of guide 72 is disposed in the
¦~ annular space 30 so that it separates the lowermost turn 110
¦l of c~theter 80 from the other turns of catheter 80 located
above it in receptacle 18. In the ready-for-use condition
~5 ~, illustrated in Figure 13, the turns of the catheter 80
located above guide 72 in the annular space 30 act upon
j~ .
--1 5--
Il .
91~ j
B2883 ~ guide 72 to press it downwardly toward base 16. With the
. catheter and guide so loaded, the dispenser 10 is assembled
and ready for utilization.
j In use, the dispenser 10 is held so that the
S ~¦ receptacle 14 and needle slot 58 are oriented away from the
¦, skin of the patient at the injection site. The needle 12
is inserted through the skin into a vein at the desired
~¦ point of entry, as indicated by the orientation of the
dispenser 10 in Figure 15. With the needle 12 in position
j in the vein, the catheter 80 and stiffener 82 are forwarded
I into the vein together by rotation of the receptacle 14 in
the clockwise direction, indicated by the arrow shown on
¦, receptacle 14 in Figure 13. The forwarding action is best
1¦ appreciated by reference to Figures 13 and 14, by which it
i will be seen that the action of guide 72 serves to continually
guide the portion of the catheter 80 coming towards outlet 53
¦ downwardly so that it lines up with such outlet. As the
¦ forwarding operation proceeds by continuing rotation of
I receptacle 18, progressively less of the catheter 80 remains
I above the guide 72. When only one turn of catheter 80
remains in receptacle 14, no portion of catheter 80 remains
abo~e the guide 72 to restrain the free end 79 of the guide
72 from its natural bias upwards~ Since ~he guide ~2 extenas
I upward from base 16 at an angle which would cause the free
1 end 79 when unrestrained to stand as high as the receptacle,
free end 79 rides directly to.the top of annular space 30
Il .
B2883 adjacent top wall 20. In such position, an automatic
stop 112 is provided by the wall 28 at i~s edge forming
the gap 32. Stop 112 is provided at that edge by the
,' thickened portion at the top of wall 28. Once only the
r~ Il, last turn of the catheter remains on the receptacle 14, and
¦I the receptacle 14 is rotated to the position illustrated in
~I Figure 14, stop 112 engages guide 72 to positively stop
¦i rotation of the receptacle 14 with respect to base 16. This
!¦ prevents over-running of the end of catheter 80 past outlet
ln ll 50, which could deform the catheter 80 and stiffener 82 by
!' kinking them at the outlet 50.
¦~ During the forwarding operation, combination of
~' the helical stiffener and silicone elastomer catheter together
¦l with the rotatin~ dispenser forwarding mechanism and slotted ¦
.15 'j needle cooperates to maximize the opportunity for successful
¦¦ catheter placement. The guide assists in the smooth control
of the catheter.
l The rotating dispenser enables the user to exercise
¦ careful control over the forwarding process. The use of the
~0 helical stiffener and elastomeric tubing with such well-
¦' controlled forwarding improves the negotiation of long and
l~ sometimes tortuous vessels with the delicate catheter whiie
Il reducing the risk of trauma. It appears that the helical
1~ stiffener leads the silicone elastomer catheter through the
1 vein as the dispenser is reeled forward.
l; . ~
!, . I
17- t
10'791
B2883 j; While reversal of the dispenser rotation might
`' otherwise risk grave danger of catheter shearing, the use of
! the slotted needle in the combination reduces the risk from
¦' the level which it otherwise might reach with the use of a
1 delicate silicone elastomer catheter.
il Once the receptacle has been rotated to the position
illustrated in Figure 14, receptacle 14 may be snapped off
, base 16 as illustrated in Figure 15. The arrangement of the
~ spindle 60 which holds dlspenser 10 together permits this
¦~ removal operation by engagement of the side walls 18 of
¦ receptacle 14 with the thumb and middle finger to pul} upward
! on receptacle 14 while the forefinger presses down on the -
¦~ button 67 to assist release of the receptacle 18 from the detent
1 bead 6~. This separation operation is thus performed without
~I need to reach a hand or any part thereof underneath base 16,
I a movement which could cause the base to be tipped up from
i the skin of the patient possibly causing addltional trauma and
b~eeding. The receptacle 14 may thereafter be discarded.
, If desired, the additional length of catheter
~ remaining outside the body may be forwarde~ into the body in
the manner illustrated in Figure 16, by gripping the catheter
hub 84 and forwarding the catheter guided by needle 12.
Needle 12 can thereaftex be removed and the needle 12 with
i attached base 16 discarded, leaving the catheter in position
~ with the hub ready to be taped or sutured down to the skin
~ of the patient in the conventional manner.
I .
1~ -18~
ii
` 10'791D~8
B2883 ;, The dispenser 10 disclosed in this application
¦ may also be used without attachment of needle 12. In such
jj form, the hub 50 can be mated with any suitable fitting to
1, forward a catheter 80 from the dispenser 10 through such
I fitting. For example~ such use could be made of dispenser
1, 10 with needle 12 omitted in a catheter-through-catheter ~CTC~
¦~ insertion. In such a procedure, an initial insertion using
l! conventional techniques is made to introduce a guide catheter.
¦~ The proximal end of the guide catheter may be provided with a
j~ suitable Luer fitting to receive hub 50 of dispenser 10,
whereupon a smaller principal catheter 80 may be introduced
from dispenser 10 through the guide catheter.
~ Having described the invention in connection with
J certain specific embodiments thereof, it is to be understood
that further modifications may now suggest themselves to
, those s~illed in the art and it is intended to cover such
¦I modifications as fall within the scope of the appended claims.
¦I This application is a division of Canadian Application
~j Serial No. 244,989, filed February 2, 1976.
"
~i . ' I
il , .
Ii , .
