U.S. patent number 3,703,174 [Application Number 05/054,732] was granted by the patent office on 1972-11-21 for method and apparatus for catheter injection.
This patent grant is currently assigned to Medidyne Corporation. Invention is credited to Gordon E. Smith.
United States Patent |
3,703,174 |
Smith |
November 21, 1972 |
METHOD AND APPARATUS FOR CATHETER INJECTION
Abstract
A device for injecting an elongated member, like a catheter,
into a passageway like a blood vessel, including a body from which
a feeding means like a needle extends and which contains the
elongated member extending into the feeding means. The space in the
body including the elongated member is sealed except for its
communication to the outside of the device through the feeding
means. There is provided a source of fluid for said space and a
means for applying pressure to the space. The elongated member is
of a smaller size then the needle passageway so the fluid placed
under pressure forms a cushion around the member which is impelled
by the pressure from the outer end of the feeding means.
Inventors: |
Smith; Gordon E. (Madison,
WI) |
Assignee: |
Medidyne Corporation (Chicago,
IL)
|
Family
ID: |
21993146 |
Appl.
No.: |
05/054,732 |
Filed: |
July 14, 1970 |
Current U.S.
Class: |
604/159; 221/64;
221/278; 226/97.1 |
Current CPC
Class: |
A61M
25/0122 (20130101) |
Current International
Class: |
A61M
25/01 (20060101); A61m 005/00 () |
Field of
Search: |
;128/214.4,221,348-351,262,218R ;221/64,278 ;226/97 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1,457,344 |
|
Sep 1966 |
|
FR |
|
1,243,331 |
|
Jun 1967 |
|
DT |
|
Primary Examiner: Truluck; Dalton L.
Claims
I claim:
1. A medical injection device for injecting an elongated member
into a passageway of the body of an animal or human, the device
including a housing having a feeding nose portion with means for
emplacing the feeding nose portion in said passageway and from
which feeding nose portion said elongated member is to be ejected
into said passageway after the feeding nose portion has been
inserted therein, said feeding nose portion having an open-ended
lumen communicating with a fluid-holding space within said housing,
a limp elongated member to be injected into said passageway located
in said space and having its front end extending into or in close
proximity to said feeding nose portion lumen where at least when
pressure is applied to said space there is a clearance between said
elongated member and the defining walls of said feeding nose
portion lumen and so the entire front end of the elongated member
and the portion behind the same except for the rear end portion
thereof can be impelled through said feeding nose portion lumen and
be guided thereby into said body passageway said elongated member
having a gum rubber-like limp consistency, means for preventing the
ejection of the rear end portion of said elongated member from said
feeding nose portion lumen, and means for selectively applying
pressure to fluid in said space to provide a cushion of fluid
flowing around said elongated member and out of said feeding nose
portion which fluid cushion impels the elongated member through the
outer end of the feeding nose portion lumen where it is ejected
from the device.
2. The injection device of claim 1 wherein said feeding nose
portion is a cannulated needle whose front end can pierce skin and
tissue, and said injection device includes means for preventing the
reverse movement of said catheter after termination of said
application of fluid pressure.
3. The injection device of claim 1 wherein said elongated member
has a permanently unset conformation so it has a substantially
straight conformation when guided into such a conformation, said
elongated member having a portion coiled a number of times in said
housing so it has a length much greater than the length of said
barrel-like member and held in a coiled condition where the
catheter readily uncoils.
4. The injection device of claim 1 wherein said feeding nose
portion is a cannulated needle adapted to be extended into a blood
vessel into which the member is to be injected.
5. The injection device of claim 1 wherein said elongated member is
beveled at the front tip thereof.
6. The injection device of claim 4 wherein said fluid is a sterile
liquid, said housing is initially completely separate from said
liquid, the assembly of said housing and feeding nose portion and
elongated member being packaged dry in a sterile condition and
sealed within an enclosure, and said housing includes
liquid-passing connecting means for externally connecting the same
to a source of said liquid when said enclosure is opened to permit
such connection.
7. The injection device of claim 6 wherein said is a barrel-like
member, and said fluid forcing means is a syringe-like unit
containing said sterile liquid.
8. The injection device of claim 1 wherein the elongated member is
resilient and has a permanently unset conformation so it has a
substantially straight conformation when guided into such a
conformation, said elongated member having a portion coiled a
number of times within the housing so it has an overall length much
greater than the length of the housing, and said coiled portion of
said elongated member resiliently engaging a portion of said
housing which holds the coils in position readily to unwind one
coil at a time.
9. A medical injection device for injecting an elongated member
into a passageway of an animal or human, the device in-cluding a
housing having a feeding nose portion from which nose portion said
elongated member is to be ejected into said passage-way, and
includes means for emplacing the feeding nose portion in said
passageway, said feeding nose portion having an open-ended lumen
communicating with a space for holding liquid within said housing,
a elongated member to be injected into said passageway and located
in said housing space and having its front end extending into or in
close proximity to said feeding nose portion lumen where at least
when pressure is applied to said space there is a clearance between
said elongated member and the defining walls of said feeding nose
portion lumen and so the entire front end of the elongated member
and the portion behind the same except for the rear end portion
thereof can be impelled through said feeding nose portion lumen,
said elongated member having a gum rubber-like consistency, means
for preventing the ejection of the rear end portion of said
elongated member from said feeding nose portion lumen, and means
for selectively applying pressure to liquid in said space for
pressurizing said liquid around said elongated member to provide a
cushion of liquid flowing around said elongated member and out of
said feeding nose portion which impels the elongated member through
the outer end of the feeding nose portion lumen where it is ejected
from the device, and the clearance space between the elongated
member and the walls of the nose portion lumen being so small
during application of said pressure that a relatively small volume
of liquid relative to the volume of liquid required to fill said
space is required to impel the entire length of the elongated
member into said passageway.
10. The injection device of claim 9 wherein said elongated member
is a catheter where both ends thereof are initially open so flow of
said liquid through said catheter is theoretically possible, but
the relative size of the catheter interior and exterior dimensions
and that of said clearance between the catheter and the feeding
nose portion lumen are such that the relative friction and pressure
condition inside and around the catheter result in little or no
liquid passing through the catheter during the ejection thereof
from said feeding nose portion of the device.
11. The injection device of claim 1 wherein the elongated member is
a catheter open at both ends and which can expand outwardly when
there is a positive pressure inside the catheter, and the clearance
space between the catheter and the wall of the surrounding nose
portion passageway during catheter injection is such that the
pressure conditions around the catheter will be greater than the
pressure conditions within the catheter so that the catheter will
not expand outwardly against the walls of the feeding nose portion
lumen to jam therein during catheter injection.
12. The injection device of claim 11 wherein the elongated member
is a catheter open at both ends and is made of a relatively
flexible material which can expand outwardly when there is a
positive pressure inside the catheter, and the rear end of the
catheter has an enlargement which, when the end of the catheter
reaches the feeding nose portion lumen, leaves little or no
clearance space between the catheter and the walls of the feeding
nose portion lumen, so that suddenly pressure in the catheter
expands the catheter outwardly positively to lock the same against
the walls of the feeding nose portion lumen to prevent the end of
the catheter from leaving the same.
13. The injection device of claim 1 wherein said fluid is a sterile
liquid and said housing has relatively deep annular pockets at the
periphery thereof which catch and hold gas bubbles.
14. The injection device of claim 13 wherein said pockets are
formed by semi-rigid but flexible longitudinally spaced pleats
formed in the walls of said housing to form accordian pleated-like
fluid forcing means, the housing being longitudinally collapsible
by collapsing said pleats, to provide the pressure therein for
ejecting the elongated member from the device into said
passageway.
15. The injection device of claim 1 wherein said pressure applying
means comprise pleats formed in said housing enabling the housing
to expand or contract at least about 10% of its normal extent and
said housing is initially completely filled with a sterile liquid
constituting said fluid.
16. A device for feeding a catheter through a hollow feeding nose
portion into a blood vessel or other passageway, the device
comprising: a body from which the feeding nose portion extends, the
body and feeding nose portion defining a space, a catheter in said
space to be fed through the feeding nose portion into the
passageway involved, the catheter being made of a resilient readily
manually stretchable material and having an enlarged portion at the
rear end portion thereof which prevents the passage thereof from
said space so the rear end portion of the catheter cannot be
ejected from the device, said enlarged portion at the rear end of
the catheter being such that, by manually pulling on the portion of
the catheter projecting from the feeding nose portion, the enlarged
portion will distend to a point where the catheter slips from said
space through said feeding nose portion.
17. The device of claim 16 wherein the device is provided with a
liquid-passing connector adapted to fit a complimentary
liquid-passing connector communicating with a liquid-holding
container, said liquid-passing connector and catheter, on the one
hand, and at least said feeding nose portion of said body on the
other hand being manually separable after the catheter has been
injected into said passageway, and said connector having a
passageway initially in spaced surrounding relationship with said
catheter and with a passageway portion within which the rear end
portion of the catheter sealingly fits at least after the catheter
has been injected into said passageway and at least said feeding
nose portion of said body has been separated from said catheter and
connector.
18. The device of claim 17 wherein said enlarged portion at the end
of the catheter includes an inner section of intermediate
enlargement which sealingly fits within said connector passageway,
functionally to hold the same in place thereon, and an outer
section of maximum enlargement which acts as a stop preventing the
pulling of the catheter through said connector unit passageway.
19. The device of claim 17 wherein there is provided means forming
an enclosure for said catheter which supports the rear end portion
of the catheter when the catheter is separated from said feeding
nose portion and is pulled toward the front of the connector
sealingly to seat the enlarged rear end portion of the catheter in
said passageway portion.
20. The injection device of claim 6 in combination with a sterile
liquid containing means having connecting means interfitted with
said connecting means of said device, said sterile liquid
containing means being a syringe unit with a plunger which can
force sterile liquid through said connecting means into said
housing to eject said elongated member therefrom.
21. A device for injecting an elongated member into a passageway of
an animal or human, the device comprising an initially liquid-free
housing having a feeding nose portion projecting therefrom and from
which feeding nose portion said elongated member is to be ejected
into said passage-way, said feeding nose portion having an
open-ended lumen communicating with a space within said housing, an
elongated member to be injected into said passageway and located in
said space and having its front end portion extending or extendable
into said feeding nose portion where the entire front end of the
elongated member and the portion behind the same except for the
rear end portion thereof can be impelled through said feeding nose
portion when liquid pressure is built up in said space, said
housing including a liquid-passing connector for externally
connecting the same to a complimentary connector of an initially
separate sterile liquid containing unit and a removable member
retaining means attached to the feeding nose portion for holding
the elongated member against movement from the feeding nose
portion, so air can first be removed from the device by forcing
liquid around the member from said liquid containing unit without
feeding the member from the device, said member retaining means
including an outer sleeve portion removably secured around said
feeding nose portion and a portion projecting into said feeding
nose portion to act as an obstruction to the movement of said
member, the assembly of said housing, member retaining means,
liquid-passing connector and elongated member being packaged dry in
a sterile condition in a surrounding sealed container.
22. The device of claim 22 wherein said projecting portion of said
member retaining means longitudinally projects into the front of
the feeding nose portion and has an open-ended passageway through
which liquid and air can pass to the outside of the device even
when the elongated member is in abutment with the rear end
thereof.
23. The injection device of claim 6 wherein said elongated member
is a catheter, and said device is combined with a bedside infusion
bottle assembly which con-stitutes said source of liquid, the
infusion bottle assembly having a connector which connects with and
forms a liquid passing joint with said connecting means of said
housing.
24. The injection device of claim 6 wherein said elongated member
is a catheter and said housing is an elongated tube with said
liquid-passing connecting means thereof on the rear end
thereof.
25. The injection device of claim 24 wherein said tube includes an
enlarged manually compressible section, the compression of which
forces the infusion liquid through the assembly to impel the
catheter through the feeding nose portion.
26. A device for injecting a catheter into a passageway of an
animal or human, the device comprising an initially liquid-free
housing including a body having a needle projecting from the front
thereof and from which needle said catheter is to be ejected into
said passageway, said needle having an open-ended lumen
communicating with a space within said body, a catheter to be
injected into said passageway located in said space in said body
and having its front end portion extending or extendable into said
needle where said entire front end portion of the catheter and the
portion behind the same can be impelled through said needle when
liquid pressure is built up in said space, said body including a
liquid-passing connector for externally connecting said space
therein to a complimentary connecting means of an initially
separate sterile liquid containing unit from which liquid is to be
drawn into said space and pressurized for catheter ejection, an
open-ended sleeve into which the assembly of said body and needle
extend, and a second liquid-passing connector removably secured to
the front end of said sleeve and to which the rear end of said
catheter is to be connected after catheter injection, said second
liquid-passing connector being adapted when separated from said
sleeve to make connection with a complimentary connector of an
external liquid-holding unit, and said catheter having an enlarged
rear end portion which cannot pass through said needle during
catheter ejection but is separable from said needle after catheter
injection to bring the same into sealed communicating relation with
said second liquid-passing connector.
27. The device of claim 6 wherein said elongated member is a
catheter, said feeding nose portion is a cannulated needle and the
catheter has means pre-venting the rear end of the same normally
from passing through the needle and there is provided a needle
cover positionable around at least the front end of the needle
after the desired length of catheter has been injected into said
passageway and the needle withdrawn therefrom.
28. A method of injecting an elongated member a substantial
distance into an artery against the flow of blood therein
comprising providing a limp elongated member of the required length
in a space in a body including a hollow feeding nose portion
through which the elongated member is to pass into the artery from
said space, said elongated member being free to bodily move
forwardly through the needle solely under the force applied by a
fluid in said space and having gum rubber-like limp consistency;
placing the end of said feeding nose portion in said artery so the
feeding nose faces in a direction opposite to the direction of the
flow of blood in the artery; applying fluid pressure to said space
to impel the elongated member out of said feeding nose portion into
the artery and removing the feeding nose from the artery.
29. A method of injecting a catheter a substantial distance into a
blood vessel having bends or constrictions therein, the method
comprising providing a catheter of the required length which is so
limp it has the consistency of gum rubber, placing the catheter
into a space in a body of an injection device including a hollow
needle through which the catheter is to pass into the blood vessel
from said space, said space being sealed except for its
communication with the outside of the body through the needle, the
catheter having an enlarged portion which becomes frictionally
locked in place in a portion of the device when the main portion of
the catheter has been ejected from said needle and being of a size
such that there will be a small clearance between it and the walls
of the needle at least when external pressure is applied thereto,
and then continuously applying a pressure to said space in said
body to impel the catheter into the blood vessel to a point where
said enlargement becomes frictionally locked in place so a back
pressure will not release the same.
30. A device for injecting a catheter into a blood vessel of an
animal or human, the device including a body having a feeding nose
portion extending therefrom to be inserted into a blood vessel,
said feeding nose portion having an open-ended passageway
communicating with a space within said body which is sealed except
for its communication with the outside of the body through said
feeding nose portion, a catheter to be injected located in said
space and having a front portion extending or extendable into said
feeding nose portion, said catheter being of a size to be bodily
fed forwardly through said feeding nose portion into said blood
vessel when force is applied thereto, a source of sterile liquid
attached to said body to be fed through said catheter into said
blood vessel while at least the rear end of the catheter remains in
said device, and means for forcing said liquid through said feeding
nose portion to aid in injecting said member into said blood vessel
by reducing the volume of said space to build up pressure therein,
said liquid forcing means being a substantially unidirectionally
manually movable means which when moved to a pressure build-up
liquid feeding position is substantially irreversible in position
until pressure is externally applied to said body.
31. The device of claim 30 wherein said liquid forcing means is a
compressible bulb-like portion on said body, the bulb-like portion
having a collapsible wall portion secured to the rest of the
bulb-like portion through a snap-action-forming joint, said
collapsible wall portion when depressed inwardly snapping into a
stable collapsed position.
32. A device for injecting a catheter into a passageway, the device
including a catheter containing body having a feeding nose portion
extending therefrom from which feeding nose portion said catheter
is to be ejected into said passageway, said feeding nose portion
having an open-ended lumen communicating with a space within said
catheter containing body, a catheter to be injected located in said
space and extending into said feeding nose portion lumen with a
clearance between it and the walls of the feeding nose portion
lumen, said catheter being resilient and readily manually
stretchable and having an enlargement at the rear end portion
thereof which effects a blocking action against the walls of the
feeding nose portion so the catheter cannot be ejected therefrom,
said enlargement at the rear end of the catheter being of such a
size that, by manually pulling on the portion of the catheter
projecting from the feeding nose portion, the enlargement will
distend to a point where the catheter slips through said feeding
nose portion, a liquid-passing connector carried by said device to
fit a complimentary connector of a liquid holding container, said
liquid-passing connector surrounding an ejected portion of the
catheter, said liquid-passing connector having a passageway within
which the rear end portion of the catheter sealingly fits at least
when the rear end of the catheter is pulled through the needle into
the connector, a sterile fluid, and means for forcing said fluid
under pressure into the feeding nose portion lumen in the clearance
space between said catheter and feeding nose portion lumen to
provide a cushion of moving fluid around the catheter which
frictionally impels the catheter through the outer end of the
feeding nose portion lumen where it is ejected from the device.
33. The injection device of claim 32 wherein said feeding nose
portion and catheter are adapted to be injected into a human blood
vessel, said catheter is coiled a number of times within the body
so it has an overall length much greater than the length of the
body and uncoils without any significant curvature so the flow of
said fluid around the catheter in said feeding nose portion readily
keeps the catheter spaced from the walls of the feeding nose
portion lumen, and said catheter is made of a material which can
remain for months in said uncoiled condition and then be uncoiled
without any significant curvature set therein.
34. The injection device of claim 32 where there is provided an
open-ended sleeve into which said body and feeding nose portion
thereof extend with the feeding nose portion projecting therefrom,
said liquid-passing connector being removably secured to the front
end of said sleeve, and said body and feeding nose portion being
bodily removable from the rear of said sleeve.
35. A method of injecting an elongated member into a blood vessel,
the method comprising providing a limp resilient elongated member
of the required length, said elongated member having a gum
rubber-like limp consistency, placing the member into a space in a
body of an injection device including a hollow feeding nose through
which the member is to pass into the passageway from said space,
said space being sealed except for its communication with the
outside of the body through the feeding nose, the elongated member
at least being of a size such that there will be a small clearance
between it and the walls of the feeding nose at least when external
pressure is applied thereto except for the end portion thereof
which cannot pass through the feeding nose, and so fluid in said
space will pass easily and swiftly around the elongated member when
the fluid is pressurized to a given extent to impel the member, and
then applying a pressure to fluid in said space in said body to
cause the fluid to flow around the elongated member and impel the
elongated member into the blood vessel.
Description
This invention relates to devices for injecting elongated members
like catheters or other hollow or non-hollow members into various
human and animal passageways. One of the most important
applications of the invention is in injecting catheters into blood
vessels for use in infusion of liquid into the vessels.
The insertion of elongated members, such as tubing or catheters of
low reactivity and long length, is frequently required in the
practice of medicine. The current method of catheter insertion into
closed vessels (as well as other closed tubes, ducts, lumina,
hollow organs, etc.) requires the manual grasping and feeding of a
relatively stiff catheter (initially carried in containers of the
same or greater length) into the vessel or other passageway
involved. This technique has numerous disadvantages, among them
being the increased risk of penetration of the vessels or other
passageways, the difficulty and sometimes the impossibility of
passing through very small vessels or relatively sharp bends or
angles in the vessels or other passageways of the body, and the
need for long housings for holding long straight lengths of the
rigid catheter or other elongated member.
Where a catheter or other elongated member is passed into a blood
vessel by this technique, it is manually pushed through the lumen
of a needle or over the needle extending into the blood vessel. If
the user should withdraw the catheter or other elongated member
before the needle is withdrawn, the elongated member can be pulled
against the sharp end of the needle where it is severed within the
blood vessel. A piece of the catheter is then left to float through
the vascular system where it poses a risk of vessel blockage. Also,
the commonly used stiff catheter for infusion of fluids into a
blood vessel often causes, for reasons to be explained, blood
vessel irritation and infection and blood leakage at the point the
catheter enters the skin.
Where the vessel or passageway involved is slit to expose the same
for passing a catheter directly into the vessel, it is possible by
present techniques to use longer and more pliable catheters which
practically eliminates the aforesaid problems of blood vessel
irritation, infection or damage, but such a placement technique
requires incision of the patient's skin with attendant discomfort
and increased operative time by the physician. The difficulty of
insertion of a very pliable catheter into a blood vessel through a
needle by manually pushing it through the needle is so great that
only relatively stiff catheters have been used for catheter
insertion by the simpler needle guiding technique.
Where a catheter is pushed through a needle into a blood vessel,
the catheter is usually provided with an enlargement on the end
which prevents the catheter from being pulled completely from the
needle. After catheter insertion, if it is desired to infuse fluid
through the catheter with the needle separated from the catheter,
the catheter must be severed at a point outside of the needle and
the end of the catheter connected to an infusion bottle assembly.
The technique and means for severing and connecting the catheter to
an infusion bottle assembly have been tedious, cumbersome and
difficult to accomplish under sterile conditions.
Accordingly, one of the objects of the present invention is to
provide an improved method and apparatus for inserting elongated
members like catheters into various human and animal passageways,
particularly blood vessels, which method and apparatus avoids the
difficulties and dangers of the methods and apparatus heretofore
utilized for this purpose.
More specifically, one of the objects of the present invention is
to provide a method of and apparatus for inserting elongated
members like catheters or the like, whether stiff or pliable,
appreciable distances into passageways with little or no effort in
contrast to the tedious effort and/or patient discomfort resulting
from the prior catheter insertion techniques and catheter insertion
apparatus. A related object of the invention is to provide a method
and apparatus as just described wherein such catheters or other
elongated member can be injected through needles long distances
into veins or arteries with a single squeeze of a bulb or movement
of a plunger or pleated body a short distance.
Another specific object of the invention is to provide a method and
apparatus as just described which is effective and poses no danger
of passageway damage even when the passageway is of very limited
size and has obstructions and sharp angles therein.
A further object of the invention is to provide apparatus for
injecting thin elongated members like catheters into blood vessels
or other passageways as described, which catheters can be made at
such a small cost that it can be a single use, disposable
device.
Still another object of the invention is to provide apparatus for
injecting catheters or the like through a needle into a blood
vessel without the danger of catheter severance within the blood
vessel. A further object of the invention is to provide apparatus
for injecting catheters or the like through a needle into a blood
vessel with an enlargement provided on the end of the catheter to
keep the end of the catheter from leaving the apparatus during
catheter injection and wherein the catheter can be easily removed
from the needle and securely interconnected with a fitting
attachable to an infusion bottle assembly or the like under sterile
conditions. A related object of the invention is providing a
catheter injection apparatus as just described which enables the
user to connect the catheter to an infusion bottle assembly
selectively with the catheter connected to the needle or
disconnected therefrom with ease and under sterile conditions.
The various aspects of the present invention satisfy one or more,
and in some cases, all of the aforesaid objectives. In accordance
with one of the aspects of the invention, it has been discovered
that an elongated member like a catheter can be most effectively
bodily impelled without affecting the basic dimensional integrity
thereof through a needle or other open ended feeding means by
securing the latter to a housing containing the elongated member
with the front end of the elongated member extending into the
feeding means so as to be readily bodily impellable therethrough.
In the most advantageous, preferred forms of the invention, the
space within the housing is sealed except for its communication
with the outside of the assembly through the front end of the open
ended feeding means. The housing contains a fluid which may be a
liquid or a gas like air which, when placed under pressure causes
first the front end of the elongated member and then the portions
thereof behind the same to be bodily impelled forwardly through the
open ended feeding means. In the injection of a catheter into a
blood vessel, the fluid used is most effectively a sterile liquid
like saline solution or the very liquid to be infused into the
blood vessel through the catheter (such as blood plasma, etc.),
and, in such case, the sterile liquid passes around the catheter in
the needle and flows out of the needle where the movement of the
fluid around the catheter aids in impelling the catheter into the
blood vessel. The present invention is so amazingly effective that
a single squeeze of a bulb or the movement of a plunger or pleated
housing body over only a small fraction of an inch can propel
almost the entire length of a catheter over 20 inches long through
a needle into a blood vessel. Since the catheter is enclosed by the
housing and needle and is not grasped in the catheter injection
process, it cannot be manually pulled back against the pointed end
of the needle extending into the blood vessel which could cut-off a
portion of the catheter which could then float free in the blood
stream.
To prevent severance of the catheter it is also advantageous to
provide an enlargement on the rear end of the catheter which
becomes frictionally locked in place in the needle or other portion
of the device at the termination of the catheter injection
operation so the development of pressure conditions causing blood
to flow backwards into the needle from a blood vessel will not move
the catheter rearwardly in the device to bring the same against the
needle, which could sever the same.
The momentum of the catheter ejected from the needle is sometimes
an important factor in ejecting long catheter lengths into blood
vessels, and where one has such control over the pressure applying
means that less than the entire length of the catheter can be
ejected each time a bulb is squeezed or a pleated housing body or
plunger is moved, the pressure should be continuously applied until
the desired length of catheter is ejected where the momentum effect
is of importance. Otherwise, the catheter may not be again
impellable from the needle once a given length has already been
injected into the blood vessel.
Although a number of aspects of the present invention are
applicable to the injection of relatively stiff catheters or other
elongated members, one of the aspects of the invention is the use
of a catheter in the catheter injection device just described which
is so pliable it has the consistency of gum rubber or a wet noodle
(i.e. it has substantial limpness with a rubber-like resilience).
Silicone elastomer is the material most advantageously used in the
present invention since, unlike gum rubber, in addition to its
limp, resilient quality, it is inert to all body fluids and tissue.
Gum rubber, wet noodles and silicone elastomer all have a high
degree of limpness with substantial resilience or elasticity; It
was found that the use of such a catheter (or other elongated
member to be injected) can have a marked effect on the size and
simplicity of the catheter injection device and on the
effectiveness of a catheter injection operation into a blood
vessel, especially when a long length of catheter is to be
injected. In the first place, such a catheter or elongated member
having a relatively long length for insertion far into a blood
vessel can be stored indefinitely in a permanently neatly coiled up
condition in a short housing only a fraction of the catheter length
where the coils will expand outwardly against the coil-confining
walls of a part of the housing. Such a limp elongated member will
unwind easily and move swiftly without any jamming in the needle or
the blood vessel. In contrast to this, an elongated member with a
modest but significant degree of rigidity will uncoil with
difficulty, so it cannot be easily and swiftly injected, if at all,
by the pressurizing of fluid around the catheter. Also, an
elongated member which is not made of such a limp material will
usually set into a curved shape when left in a sharply bent or
coiled condition for only a few hours, and will jam inside the
needle or housing, making injection there of unsatisfactory or even
impossible.
Another important advantage of a catheter or the like used in a
vascular application and having a wet noodle like consistency is
that, unlike rigid and semi-rigid catheters or the like, a
difficult to break liquid and bacteria tight seal is formed around
the catheter at the point it enters the skin. (After insertion of a
catheter or other elongated member into a blood vessel through a
needle, the needle is pulled from the patient and discarded or
positioned in a way not to damage the user's skin.) With semi-rigid
or rigid catheters, patient or catheter movement causes the skin to
pull away from the catheter or the catheter to pull away from the
skin, causing openings for leakage of blood and passage of bacteria
and contaminants. Where the catheter has a wet noodle like
consistency, patient and catheter movement is not readily
transmitted to the point where the catheter passes through the skin
so the skin is not readily separated from the catheter and the skin
can readily form a seal around the soft pliable catheter
material.
Furthermore, a straight stiff catheter will not readily pass
through a blood vessel having an obstruction to easy passage of a
conventional rigid or semi-rigid catheter, as where the vessel
bends or is constricted, because such a catheter will catch on such
obstruction and can easily penetrate the vessel if an attempt is
made to force the catheter. Also, a stiff catheter will sometimes
catch on the walls of even a straight blood vessel, thus precluding
satisfactory advancement. When the catheter is made of a material
with a wet noodle consistency, if the catheter should hit an
obstruction in the blood vessel it is so flexible that it will not
cause any injury to the vessel and will not usually jam within the
vessel because such a catheter will readily pass around the
obstruction and will tend to keep a centered position in the blood
vessel.
A further aspect of the invention is the provision of a bevel at
the front end of the limp catheter (which would be unthinkable in a
stiff catheter since the stiff catheter would then form a needle
capable of readily piercing the blood vessel involved). The bevel
on the front end of such a catheter enlarges the area of the
catheter entryway to prevent formation of blood clots thereat,
eliminates a collapsible body at the point where the tubular
catheter is most prone to collapse to obstruct the withdrawal of
blood from the vessel and makes the catheter tip so flexible that
the catching of the catheter tip on an obstruction will not jam the
catheter since the catheter tip can readily fold upon itself
permitting the portion of the catheter behind the tip to pass by
the same and then pull the folded back tip from the
obstruction.
Another aspect of the application of the invention where a catheter
is injected into a blood vessel is the provision of an enlargement,
preferably a two-stepped enlargement, at the rear end of the
catheter for preventing the rear end of the catheter from leaving
the needle during the catheter injection operation. The first
enlargement at the end of the catheter reaching the needle provides
the aforesaid friction lock in the needle which prevents subsequent
reversal of movement of the catheter. More importantly it reduces
this clearance space to zero whereupon the pressure inside of the
catheter causes the catheter to expand against the needle walls
securely holding the catheter against further movement which the
friction fit between the catheter and needle could not normally by
itself achieve. The second enlargement at the very end of the
catheter, among other things, acts as a further insurance against
the catheter leaving the needle during catheter injection. After
withdrawal of the needle from the patient, the extremely flexible
catheter can be removed from the needle by simply pulling on the
catheter to elongate and contract the diameter of the enlargements
on the end of the catheter which then slips through the needle as
it is so elongated and contracted.
The various above described features of the invention are, in
accordance with more specific aspects thereof, utilized in
different types of catheter injecting devices. Thus, in one form of
the invention used for injection of catheters or the like into
blood vessels, the device is a completely self-contained unit
packaged and sterilized at the point of manufacture with saline
solution or the like in the unit. Where the application of the
invention is one where the catheter injection device need not
incorporate a sterile liquid at the point of manufacture, the
device may include a very small inexpensive, easy-to-sterilize,
liquid-free, catheter containing barrel-like body which does not
have any means for applying pressure to the barrel. The barrel-like
body is readily supplied with the sterile liquid at the point of
use by attaching it through a connector to the front end of a
conventional syringe unit (with its needle removed) which is
regularly stocked at hospitals and doctor's offices. The syringe
unit to which the catheter injection device is connected is already
filled with a sterile saline solution or the like in the
conventional way used to fill syringe units with liquid. The
plunger of the syringe unit then becomes the instrumentality for
forcing liquid through the barrel-like body and needle of the
catheter injection device. Before using the device, air must first
be expunged therefrom. This is accomplished by orienting the
assembly so the needle of the catheter injection device points up,
and then pushing the plunger of the syringe unit until liquid flows
out the end of the needle. A removable liquid-passing catheter
retaining means is provided on the needle to prevent the movement
of the catheter from the needle while the air is removed in the
manner explained.
In the specific forms of the invention described above, the
catheter, after being injected into a blood vessel, can be removed
from the needle and attached to an infusion bottle assembly by a
connector carried by the catheter injection device which connector
slides over the catheter which is pulled into a locked sealed
position in the connector. The various forms of the invention can
and preferably are designed to provide the user the option of
connecting the catheter to an infusion bottle assembly in a manner
which does not require removal of the catheter from the needle.
In another form of the invention, the catheter injection device is
designed to be connected to an infusion bottle assembly before the
catheter is injected and a small quantity of the infusion liquid is
drained from the infusion bottle into the initially dry catheter
injection device to become the catheter infusion liquid. When the
user desires to give a transfusion of blood or start an intravenous
feeding operation, the needle at the front end of the device is
inserted into the blood vessel involved and the catheter is
injected into the vessel by squeezing a bulb-like member or the
like. The needle is then withdrawn from the patient and, if
desired, the catheter is pulled from the needle and separated from
the entire catheter injection device and reconnected to the
infusion bottle assembly, or the catheter left attached to the
device. In the latter case, a needle cover is applied over the
needle to protect the patient and the catheter from the needle.
Although it is preferable and most advantageous to use manually
applied pressure to cause the liquid to inject a catheter into the
blood stream, in the example of the invention just described, it is
within the purview of some of the aspects of the invention to use
the gravity forced flow of liquid to force the catheter from the
needle into a blood vessel in the direction of blood flow
therein.
Where manual force is used to create a flow of liquid which impels
the catheter into a blood vessel, where the catheter remains
attached to the catheter injection device it is important that the
portion thereof squeezed or otherwise moved to decrease the volume
of the liquid-filled system involved be a unidirectionally movable
member to avoid the creation of a negative pressure which could
draw air into the device when the needle is withdrawn from the
patient and before infusion of liquid through the catheter begins.
Accordingly, where a squeeze bulb is provided, the bulb is designed
so it snaps into a permanently collapsed condition when squeezed
until infusion of fluid through the device is again initiated which
then creates a pressure which expands the bulb into its original
shape.
It should be understood that some of the aspects of the invention
are useful in applications where it is not desirable or necessary
to use a liquid as the impelling medium. Thus, for some
applications, the catheter impelling fluid may be air. Such
applications would be the injection of a catheter or other
elongated member into the urethra, rectum, ear, throat, lungs,
etc.
The above described and other objects, advantages, and features of
the invention will become more clear and apparent upon making
reference to the specification to follow, the claims and the
drawings wherein:
FIG. 1 is a view of one form of the invention comprising a
self-contained, sterile liquid containing catheter injection device
resembling a syringe unit with an enclosure applied to the needle
containing end thereof;
FIG. 2 is an enlarged longitudinal sectional view through the
catheter injection device shown in FIG. 1 and enclosure
thereof;
FIG. 3 is an enlarged fragmentary sectional view of the needle end
of the catheter injection device shown in FIG. 2 after removal of
the enclosure and needle cover, the device shown being used to
inject a catheter into a blood vessel;
FIG. 4 is a greatly enlarged transverse sectional view through the
needle shown in FIG. 3;
FIG. 5 is a greatly enlarged fragmentary longitudinally sectional
view of the base or inner end of the needle of the catheter
injection device shown in FIG. 3, as the enlarged rear end of the
catheter reaches the rear end of the needle;
FIG. 5A is a perspective view of the rear end of the catheter
showing the enlargement on the end thereof;
FIG. 6 illustrates the withdrawl of the needle from the blood
vessel shown in FIG. 3 as a first step in removing the catheter
from the catheter injection device involved;
FIG. 7 is a view corresponding to FIG. 6 showing the infusion
liquid-receiving connector unit initially surrounding the needle
shifted into a position immediately beyond the tip of the needle
where it is positioned around the catheter;
FIG. 8 is an enlarged fragmentary sectional view of the rear end of
the needle showing the elongation and contraction of the enlarged
end of the catheter caused by a pulling force applied to the
catheter, permitting the same to pass through the needle;
FIG. 9 is a view of the front end of the needle as the end of the
catheter is being pulled therefrom;
FIG. 10 is a view of the infusion liquid-receiving connector unit
when the enlarged end of the catheter of FIG. 9 has been pulled
into its final snugly fitting position within the infusion
liquid-receiving connector unit;
FIG. 11 is a view corresponding to FIG. 10 when the end connector
of an infusion bottle assembly has been secured within the
connector unit of FIG. 10;
FIG. 12 is a perspective view of an infusion bottle assembly
showing the end connector thereof adjacent the infusion
liquid-receiving connector unit of the catheter injection device
shown in FIG. 11;
FIG. 13 illustrates a second form of the invention comprising a
self-contained, sterile liquid containing catheter injection device
and with an enclosure applied around the needle containing end
thereof;
FIG. 14 is an enlarged longitudinally sectional view through the
catheter injection device and enclosure of FIG. 13;
FIG. 15 is a greatly enlarged side elevational view of the needle
and its mounting hub used in the catheter injection device of FIGS.
13 and 14, before the needle assembly has been assembled with other
parts of the device;
FIG. 16 is a substantially enlarged fragmentary longitudinal
sectional view of the rear end of the needle assembly of FIG. 16,
taken along section 16-16 thereof;
FIG. 17 shows a third and preferred form of the invention
comprising a self-contained sterile liquid containing catheter
injection device and with an enclosure applied thereto encompassing
most of the length thereof;
FIG. 18 is an enlarged longitudinal sectional view through the
catheter injection device and the enclosure thereof of FIG. 17;
FIG. 19 is a longitudinal sectional view of the catheter injection
device of FIG. 18 after the enclosure and needle cover have been
removed therefrom;
FIG. 20 is a greatly enlarged fragmentary longitudinal sectional
view of the inner end portion of the needle assembly of the
catheter injection device of FIG. 17 through 19, showing the manner
in which the needle assembly is mounted within the device;
FIG. 21 is a greatly enlarged fragmentary longitudinal sectional
view through the pleated portion of the catheter containing body of
the catheter injection device of FIGS. 17 through 20, showing the
manner in which air bubbles are trapped therein;
FIG. 22 is a fragmentary longitudinal sectional view of the rear
end portion of a catheter injection device constituting a variation
of the form of catheter injection device shown in FIGS. 18 through
21;
FIG. 23 is a plan view of a non-self-contained liquid-free form of
the present invention packaged in a flexible, transparent sealed
bag, which device must be connected to a conventional liquid
containing syringe unit or the like to form an overall assembly
capable of injecting a catheter into a blood vessel or the
like;
FIG. 24 is an enlarged longitudinal sectional view of the catheter
injection device of FIG. 23;
FIG. 25 is an enlarged fragmentary sectional view of the catheter
injection device of FIG. 24 assembled with a conventional syringe
unit;
FIG. 26 is a greatly enlarged longitudinal sectional view of the
front end portion of the assembly of FIG. 24, showing the manner in
which air is ejected from the assembly;
FIG. 27 is another form of the invention comprising a
non-self-contained, liquid-free catheter injection device which
forms a complete catheter injection device when connected to a
conventional infusion bottle assembly;
FIG. 28 shows the connection of the catheter injection device of
FIG. 27 to an infusion bottle assembly;
FIG. 29 is an enlarged longitudinal sectional view of the catheter
injection device shown in FIG. 28;
FIG. 30 is a fragmentary longitudinal sectional view of the front
end portion of the catheter injection device of FIG. 29 after a
needle cover has been removed therefrom;
FIG. 31 is a fragmentary longitudinal sectional view of the
squeeze-bulb portion of the catheter injection device of FIGS. 27
through 30 after the same has been operated to inject a catheter
into a blood vessel and before re-establishment of infusion;
FIG. 32 is a fragmentary longitudinal sectional view of the front
end portion of the catheter injection device of FIG. 30 after a
catheter has been injected into a blood vessel and the needle
withdrawn within a needle retraction sleeve, where infusion of
liquid through the catheter is to be effected through the catheter
injection device;
FIG. 33 is a view showing the separation of the catheter and
infusion liquid-receiving connector from the rest of the catheter
injection device when it is desired to feed an infusion liquid
through the catheter separately from the catheter injection device;
and
FIG. 34 is a longitudinal sectional view of the catheter and
infusion liquid-receiving connector of FIG. 33 attached to the
complementary connector of the infusion bottle assembly of FIG.
28.
EMBODIMENT OF THE INVENTION SHOWN IN FIGS. 1-12
The embodiment of the invention shown in FIGS. 1-12 is a catheter
injection device 2 which is a self-contained, sterile
liquid-containing device resembling a needle syringe unit. It
includes a catheter-containing body assembly 6 comprising a
cylindrical barrel 6a, which may be made of a suitable synthetic
plastic material such as polyethylene and the like, from the front
end of which extends a catheter feeding needle 6b. The needle has
attached thereto a conventional hub 7 preferably made of a
synthetic plastic material which hub interfits in a conventional
way with the reduced nose portion 8 at the front end of the barrel
6a. The rear end of the barrel 6a terminates in a pair of laterally
extending finger-receiving wings 10--10 and is open slidably to
receive the body portion of a plunger stem 6c which may be made of
the same synthetic plastic material as the barrel 6a. The plunger
stem 6c has at the front end thereof a head portion 12 which makes
a sealing and sliding engagement with the inner surface of the
cylindrical chamber 14 of the barrel 6a. A catheter 12 is coiled
within the cylindrical barrel chamber 14 which retains the same in
a neatly coiled condition so the coils will easily uncoil under the
force of the forwardly moving catheter ahead of the same front end
portion of the catheter extends substantially into the lumen 16 of
the needle 6b. The catheter 12 is shown provided with equally
spaced index marks 13 thereon to provide an indication of the
distance between the front end of the catheter and any given
position thereon in a manner to be described. The tip 12' of the
catheter is beveled for reasons previously explained and marked
with a wide marker 13' so that upon withdrawal of the catheter from
a blood vessel the user can identify the end of the catheter to be
certain that no catheter breakage has taken place. The barrel
chamber 14 is filled with a suitable sterile liquid 18 such as a
saline solution which also fills the needle lumen 16 and a space in
front of a needle cover 20 whose closed front end snugly surrounds
the needle 6b and forms a tight liquid seal therewith at a point
just rearward of the beveled front end of the needle. The rear open
end of the needle cover 20 flares outwardly and snugly engages
around the beveled front end portion of an infusion
liquid-receiving connector 22 snugly but slidably disposed around
the base portion of the needle just in front of the needle hub 7.
The needle cover maintains a seal even during the sterilizing
process preferably used, which is an autoclaving process. The
needle cover 20, connector 22 and the needle hub 7 are enclosed by
an outer dust cover-forming enclosure 24 which is closed at its
front end and open at its rear end where it telescopes snugly
around the front of the main body portion of the barrel 6a. The
outer enclosure 24 and the needle cover 20 may be made of a
suitable synthetic plastic material, such as polyethylene and the
like.
Although, in accordance with the broadest aspects of the invention,
the catheter 12 could be made of an uncoiled rigid or semi-rigid
material, it is most advantageous that the catheter be made of a
material which is so limp that it was not heretofore thought
possible to inject the same into a blood vessel, manually or
otherwise. The catheter 12, which is most desirable made of a
silicone elastomer or other similar inert limp, resilient material,
is so limp and pliable that it has the consistency of gum rubber or
a wet noodle. Silicone elastomer materials are in solid form
incompressible but when hollow like a catheter can be compressed
inwardly. It is also of significance that the catheter 12 be made
of a material which can remain in a fairly tightly coiled condition
as illustrated indefinitely without any significant curvature
setting therein, so that the catheter will at all times uncoil in a
straight condition when it is fed through the needle. If the
catheter had any substantial curvature set therein, the catheter
could readily catch on the walls of the needle or housing making it
impossible to feed the catheter from the needle.
The catheter 12 must be of a size during a catheter ejection
operation to pass freely but preferably with a small clearance
through the needle lumen 16. In one exemplary form of the
invention, the diameter of the needle lumen was 0.052 inch, the
outer diameter of the catheter was 0.047 inches and the inner
diameter of the passageway within the catheter was 0.025 inches.
(It should be understood that the various dimensions are given by
way of example only since the dimensions obviously vary widely with
the desired catheter size and other factors.) A small clearance
space is preferred between the needle lumen and the catheter so
that a small movement of the plunger stem 6c will result preferably
in a high velocity flow of liquid around the catheter to provide a
moving fluid cushion around the catheter which will impel the same
from the needle and uncoil the catheter. The limpness of the
catheter allows the catheter to uncoil with ease and to readily
enable the catheter to be centered in the blood stream and to
readily allow the same to pass around obstructions and sharp bends
in the blood vessel. Also the momentum of the extremely limp
catheter material adds much to the amazing easy injection of the
catheter substantial distances into the blood vessels involved.
Thus, it was found that the velocity of ejection of the catheter is
substantially greater for a long catheter. It was found, for
example, that a movement of the plunger stem 6c to effect delivery
of 1 cc. of fluid was sufficient to uncoil and eject a limp
catheter having lengths of from 12 or more inches into a vessel.
This generally means that the syringe plunger 6c need be advanced
only a small fraction of an inch to impel a catheter of 12 to 26
inches and more.
It would be especially undesirable to have liquid flowing through
the catheter under such pressure conditions that the catheter would
expand outwardly against the lumen-defining walls of the needle 6b,
which would prevent the free movement of the catheter through the
needle. To this end, it would appear desirable to make the
cross-sectional area of the passageway within the catheter
substantially less than that of the clearance space between the
catheter and the lumen-forming wall of the needle 6. However, with
the exemplary dimensions given above, the cross-sectional area of
the catheter passageway is actually larger than that of the
clearance space for the catheter. This curious result is due
probably to the fact that because of the length of the catheter
behind the needle there is a much greater frictional opposition to
the flow of liquid at the interface between the liquid and the
inner walls of the catheter than there is at the interface between
the liquid and the inner walls of the needle passageway which
results in a lower pressure inside the catheter where it enters the
needle. Although there is liquid within the catheter before the
same is impelled, the application of the pressure results only in
the forward flow of catheter impelling liquid around the catheter,
the liquid within the catheter having no appreciable forward
component of flow relative to the forward moving catheter.
Consequently, no liquid flows from inside the catheter during
catheter ejection.
To inject the catheter into a vessel, it is obviously necessary
first to remove the outer enclosure 24 and the needle cover 20. A
tourniquet is placed on the limb involved, and after insertion of
the end of the needle 6b through the skin 25 into the vein 27 as
shown in FIG. 3, a small depression imparted to the plunger stem 6c
will place pressure on the saline solution 18 to force the liquid
around the catheter in the needle 6b which will surprisingly eject
the entire length of the catheter 12 from the barrel 6a except for
the rear end thereof. As best shown in FIG. 5A, the rear end of the
catheter 12 preferably has a two-step enlargement, the first step
of the enlargement being identified by reference numeral 12a and
the second step thereof being identified by reference numeral 12b.
The inner end of the first enlargement 12a joins the catheter body
in front of the same through a forwardly tapered or beveled portion
12a' (FIGS. 5, 5A and 8). The wall thickness of the first and
second enlargements are progressively greater than that of the rest
of the catheter to provide an increase rigidity with diameter. As
shown in FIG. 5, the outer diameter of the first enlargement 12a is
somewhat greater then the inner diameter of the needle 6b so that
when the taper 12a' at the enlargement 12a reaches the needle 6b
the clearance space between the catheter and the needle lumen is
reduced to zero and the catheter stops. Also, as shown in FIG. 5,
the tapered front end portion 12a' of the first enlargement 12a
enters the needle lumen; At that time, the pressure of liquid in
the passageway of the catheter, will expand the expandable catheter
outwardly to force the same snugly against the needle wall which
maintains the stoppage of movement of the catheter through the
needle.
As previously indicated, the fact that the size of the enlargement
12a is greater than the inner diameter of the needle also
frictionally keeps the catheter in the needle and prevents any
passable backward movement of the catheter which could bring the
catheter against the sharp end of the needle to sever the catheter.
Such backward movement without a friction fit could occur if the
user withdrew the plunger stem 6c.
Referring now to FIG. 6, after the catheter has been injected to
its maximum degree into the blood vessel involved, the tourniquet
applied to the patient's arm may be removed. Blood may back flow
into the catheter to fill at least in part the same with blood. The
needle 6b is then withdrawn from the patient and, in a manner to be
described, the catheter 12 is removed from the needle to permit the
catheter to be attached to a source of infusion liquid by means of
the infusion liquid-receiving connector 22. After the needle 6b has
been removed from the patient, if the doctor desires less than the
full length of the catheter to extend into the blood vessel
involved, he withdraws the catheter the proper distance by counting
the number of index marks 13 of the catheter 12 which are removed
from the patient during the withdrawal of the catheter.
The infusion liquid-receiving connector 22 has a front cylindrical
portion 22a and a rear outwardly flaring portion 22b. The front
portion 22a of the connector 22 has a passageway 30 therein
interrupted preferably by one or more grooves 32 to minimize the
area of the defined walls of the passageway 30 which frictionally
engages the needle 6b, so that the connector can be easily pulled
from the needle by pulling the same down along the needle 6b to a
point where it slides off the needle and surrounds the catheter 12
as shown in FIG. 7. The connector passageway 30 merges with a
relatively short opening 34 of greater diameter which opening is of
a size to accommodate the outermost enlargement 12b of the
catheter. The first enlargement 12a of the catheter is of a size
which snugly fits within the connector passageway 30. The opening
34 within the front portion 22a of the connector 22 joins a still
larger cylindrical space 36 which is of a size frictionally to
receive the nose portion 38 of a connector 40 (see FIG. 11) at the
end of an infusion bottle assembly 39 to be described.
The enlargements 12a and 12b at the end of the catheter 12 are made
of such a size and thickness as illustrated so that by pulling on
the catheter 12 the enlargements will distend in length and
contract in diameter so the catheter can be readily pulled through
the needle 6b, as shown in FIGS. 8 and 9. When the catheter is
removed from the needle 6b, the catheter is pulled to the front of
the connector 18 where the innermost enlargement 12a snugly fits
within the aforementioned connector passageway 30 and the outermost
enlargement 12b fits within the aforementioned connector opening
34, as shown in FIG. 10 where, because of the relative thickness
and size thereof, it acts as a stop abutment preventing the
catheter from being pulled through the connector passageway 30. The
outwardly flaring rear portion 22b of the connector 22 defines a
skirt which prevents the end of the catheter from dropping upon an
unsterile surface when the end of the catheter leaves the needle
6b. It is, of course, important to keep sterile those outer
surfaces of the catheter which engage that part of the connector 22
which can be contacted by the infusion liquid to be directed
through the catheter 12.
The separation of the catheter from the needle is desirable for a
number of reasons including the fact that after catheter injection
the needle can be disposed of so that there is no problem of
keeping the needle from scratching the patient's skin or puncturing
the catheter. However, the catheter need not be separated from the
needle. The needle hub 7 is of a standard shape so after catheter
injection where the enlarged end 12a of the catheter is sealed
within the rear end of the needle, the needle can be removed from
the barrel 6a and connected to the connector 40 of the infusion
bottle assembly. In such case, the infusion liquid-receiving
connector 22 is pulled down to a point where it covers the sharp
beveled end of the needle 6b as shown in dashed lines in FIG.
6.
The conventional infusion bottle assembly 39 illustrated in FIG. 12
includes a relatively long flexible tube 43 extending from an
inverted bottle 44 containing the infusion fluid. The bottle 44
includes a strap 47 extending around the bent portion 48 of a
horizontally extending arm 50 of a support stand 51. The arm 50
extends from a vertical rod section 52 vertically adjustable within
a tubular base 54. The flow of fluid from the bottle 44 is
controlled by a pinch clamp 46 applied around a portion of the tube
43. Before the connector 22 to which the catheter 12 is attached is
connected to the infusion bottle assembly connector 40, the clamp
46 is released so that the entire length of the tube 43 and the
connector 40 is filled with the infusion fluid involved, so that
there is no air which passes along with the infusion fluid. As
previously indicated, the catheter 12 extending from the patient is
filled with blood and/or a portion of the injecting fluid so that
it too is free of air.
It should be noted that in the embodiment of the invention just
described the saline solution 18 within the barrel 6a makes contact
with the needle hub 7. If the needle hub 7 were made of a metal
like aluminum, the saline solution will corrode the same if the hub
is subjected thereto for prolonged periods of time. The use of a
needle with a synthetic plastic hub as described, although
desirable, is presently unsatisfactory because, the manner in which
commercially available needles with plastic hubs are made, the
connection between the plastic hub and metal needle cannot
withstand the conditions of the sterilizing process required to
sterilize the saline solution-filled catheter injection device
2.
EMBODIMENT OF THE INVENTION OF FIGS. 13-16
The catheter injection device shown in FIGS. 13-16 and identified
by reference numeral 56 comprises a catheter containing body
assembly 58 including a tapered barrel 58a preferably made of
polyethylene or other suitable synthetic plastic material, a
stainless steel needle 58b secured to the front end of the barrel
58a, and a depressible end cap 58c at the rear end of the barrel
58a preferably made of a suitable synthetic plastic material like
polyethylene. The barrel 58a defines a forwardly tapering chamber
60 which opens onto the front and rear of the barrel 58a. The outer
surface of the barrel 58a terminates at the rear thereof in a
cylindrical rear end portion 62 which sealingly receives the end
cap 58c. The catheter containing body assembly 58 is filled with
saline solution 18' and the catheter is coiled within the end cap
58c and extends through the barrel 58a into the needle 58b. The end
cap 58c is sufficiently snugly mounted around the barrel 58a that
it forms a liquid seal and remains in the position illustrated
until the user depresses the same inwardly to reduce the volume of
the space within the catheter containing body assembly 58, to
effect ejection of the catheter 12 in the same manner as explained
in connection with the catheter injection device of FIGS. 1-12.
The defining walls of the barrel chamber 60 taper gradually to a
reduced point at the front end of the barrel where the barrel
terminates in a cylindrical nose portion 63. The needle 58b is
anchored in place at the front end of the nose portion 63 of the
barrel 58a by means including a needle holder member 64 having a
skirt 64 (FIG. 14) which extends securely around and is anchored to
the nose portion 63 of the barrel 58a. The needle holder member 64
has a cylindrical bore 66 therein which receives a deformable but
not too compressible sleeve 70 surrounding the rear end of the
needle. As best shown in FIG. 16, the rear end of the needle 58b
terminates in a flared end position 58b' on the inner side of which
the sleeve 70 is mounted. The flared end 58b' of the needle abuts
against a correspondingly shaped end surface of the nose portion 63
of the barrel 58a. The forward end of the bore 66 of the needle
holder member 64 is defined by a wall or shoulder which presses
longitudinally rearwardly on the sleeve 70 to cause the same to
deform outwardly so the sleeve becomes tightly sandwiched between
the needle 58b and the defining wall of the bore 66 of the needle
holder member 64. The manner in which the needle 58b is anchored as
just described is an inexpensive and effective means for mounting
hubless needle bodies, overcoming the problem of corrosion present
when using needle bodies secured to metal hubs and the problem of
withstanding sterilization conditions when needle bodies using
conventional plastic hubs are utilized. It should be understood,
however, that the form of the invention shown in this application
using the unique needle anchoring technique just described could be
modified to use needle bodies with plastic hubs as shown in the
embodiment of FIG. 2 if the manufacturing techniquesused thereon
are improved to permit them to be used in the sterilization process
required for the saline solution-filled embodiments of the
invention.
An infusion liquid-receiving connector 68 substantially identical
to the previously described connector 22 closely surrounds the
inner end of the needle 58b, with the outwardly flaring rear end
portion 68b thereof engaging the front outer surface of the needle
holder member 64. A liquid sealing needle cover 69 like the needle
cover 20 previously described sealingly engages the needle behind
the bevel at the front end thereof and engages the forward end of
the connector 68. A cylindrical closure member 71 forms a dust
cover around the needle 58b, the connector 68 and the holder member
64. The closure member 71 which is open at its rear end,
frictionally engages and is anchored around the needle holder
member 64.
THE EMBODIMENTS OF FIGS. 17-22
Refer now more particularly to FIGS. 17-19 which shows the most
preferred form of a self-contained, catheter injection device
identified by reference numeral 72. This form of the invention has
a housing 74 which encloses the catheter injection device 72 (FIGS.
18-19) substantially its entire length, unlike the enclosure 24 of
the embodiment of FIG. 1 and the enclosure 70 of the embodiment of
FIG. 13 which encloses only the front end portion of the device
including the needle, needle cover and infusion liquid-receiving
connector. The catheter injection device 72 has a catheter
containing body assembly 76 comprising a barrel 76a made of a
suitable synthetic plastic material and opened at the front
thereof. The barrel 76a is shown cylindrical in shape for most of
its length and is interrupted by longitudinally spaced,
accordion-like pleats 78 forming deep peripheral pockets 80 on the
interior of the barrel. The pleats 78, which are shown as having
generally triangularly shaped cross sections, enables the barrel to
be expanded or contracted preferably at least about 10 percent of
its initial length. The rear end of the barrel 76a has a rearwardly
flaring portion 82 terminating in an enlarged cylindrical end
portion 84 which is closed off at the end thereof by a concave wall
86. The housing 74 has a closed front end 74a and an open rear end
74b which is snugly applied over the enlarged end portion 84 of the
barrel 76a. The catheter 12 is coiled up within the enlarged end
portion 84 of the barrel 76a, the catheter extending the length of
the barrel and passing into the needle 76b.
The front end of the barrel 76a is provided with an internal
annular locking rib 88 and external annular locking ribs 92 (FIG.
20). Where, as illustrated, the pleats 78 imparts such flexibility
to the barrel 76a that the barrel cannot support itself in a
straight condition, the pleated portion of the barrel is given
support by a sleeve 92 extending in close proximity to the barrel
76a within the barrel chamber 90. The sleeve 92, which like the
other parts may be a synthetic plastic molded part, has a thick
front end portion 94 with a shoulder 93 therein behind which
extends the aforementioned internal locking rib 88.
The catheter containing housing assembly 76 further includes the
needle 76b carrying on the inner outwardly flaring end thereof a
needle mounting sleeve 95 like the sleeve 70 in FIGS. 15 and 16.
The thick front end portion 94 of the pleat support sleeve 92
presents a forwardly facing inwardly tapering conical surface 98
which forms an abutment for the outwardly flared rear end of the
needle 76b. The flared ends of needles of various sizes can be
accommodated by the forwardly facing conical sleeve surface 98. The
needle 76b is anchored in place by a needle holder member 100
having a cavity 102 therein which opens rearwardly of the member.
The cavity 102 has recesses 104 corresponding to the external
locking ribs 93 of the barrel 76a, permitting the needle holder
member 100 to be snapped into place around the front end of the
barrel 76a. The needle holder member 100 has an internal hub 105
with a longitudinal bore 107 therein through which extends the
needle 76b. When the needle holder member 100 is snapped into place
on the front end of the barrel 76a, the rearwardly facing end of
the internal hub 105 of the needle holder member 100 deforms the
needle mounting sleeve 95 so it conforms to the irregular shape of
the conical surface 98 at the front end of the sleeve 92, thereby
securely to anchor the needle 76b in place, as best shown in FIG.
20.
The needle 76b carries a needle cover 110 which snugly is applied
around the needle to cover and seal the same in the same manner as
the other needle covers previously described, and an infusion
liquid-receiving connector 112 positioned at the rear end of the
needle cover 110. The connector 112 is identical to the infusion
liquid-receiving connectors previously described in connection with
the other embodiments of the invention.
The various interconnecting spaces within the catheter injection
device 72 are filled with a sterilized saline solution 113 as in
the case of the other embodiments of the invention. The catheter
injection device 72 is used in a manner similar to the other
catheter injection devices previously described except that the
saline solution is ejected around the catheter by placing the thumb
against the concave rear wall 86 of the barrel 76a and the other
fingers in front of the pleats 78 and pulling the thumb toward the
fingers so the volume of the chamber 90 within the barrel is
reduced, so the catheter impelling liquid is forced through the
needle 76b and around the catheter 12 to eject the same in the
manner described previously. If there should be any air bubbles
within the barrel chamber, the deep pockets 80 formed by the pleats
78 in the embodiment of the invention shown in FIGS. 18 and 19 will
catch any air bubbles moving toward the needle and entrap the same
as shown in FIG. 21 if the catheter injection device is operated in
a position where the needle end points in a downward direction
during catheter injection.
FIG. 22 illustrates a modification of the form of the invention
shown in FIGS. 17 through 19 in that the pleats 78' are formed at
the end of the barrel beyond the enlarged rear end 84' thereof
which houses the coiled up portion of the catheter 12.
EMBODIMENT OF THE INVENTION OF FIGS. 23-25
As previously indicated, it is desirable to manufacture and package
a catheter injection device in a dry state (i.e. without the
presence of any sterile catheter impelling liquid) when a source of
such a liquid is available at the point of use of the catheter
injection device. To this end, the embodiment of the invention
shown in FIGS. 23-25 was developed.
The catheter injection device 112 shown in FIGS. 23-25 is
preferably packaged in a transparent synthetic plastic bag 114 in
which it can be sterilized in accordance with well-known gas
sterilizing techniques. The catheter injection device 112 includes
a catheter containing body assembly 115 including a short barrel
115a having a relatively large cylindrical portion 117 closed by a
cap 119 having a hollow neck 121 projecting rearwardly therefrom
with an open-ended passageway 123 communicating with a catheter
containing chamber 125 in the barrel 115a. The neck 121 is adapted
to interfit with the nose portion 127 of a conventional syringe
unit barrel 129 shown in FIG. 25 or with the connector 40 of an
infusion bottle assembly where infusion of liquid is to be made
through the catheter injection device 112. In the exemplary barrel
115a, the barrel has a forwardly tapering wall portion 131
extending from the front end of the cylindrical barrel portion 117,
wall portion 131 terminating in a cylindrical neck 133 having an
apertured end wall 135. Extending forwardly from the apertured end
wall 135 is a hollow cylindrical sleeve 137 in which is mounted a
needle 115b carrying at the rear end thereof a deformable sleeve
139. The sleeve 139 on the needle 115b serves the same purpose as
the sleeve 95 on the needle 76b described in connection with the
embodiment of the invention as shown in FIG. 18. The needle 115b
has a flared end 140 which engages the end wall 135 of the neck 133
of the barrel 115a around an aperture 142 therein. The needle
sleeve 139 is expanded tightly into engagement with the defining
walls of the needle-receiving chamber 144 within the sleeve 137 by
an internal hub 146 of a needle holder member 148 which is snapped
into a position around the sleeve 137. An interfitting projection
137a and recess 148a are provided on the sleeve 137 and the needle
holder member 148. An infusion liquid-receiving connector 150
surrounds the needle 115b immediately behind the needle holder
member 148. The connector 150 is of the same construction and
serves the same function as the previously described infusion
liquid-receiving connectors. The barrel 115a contains a coiled up
catheter 12 which has a portion extending into the needle 115b.
The front end of the needle 115b is initially covered by an
open-ended needle cover generally indicated by reference numeral
152. As best shown in FIG. 26, the needle cover 152 has a main
cylindrical portion 152a defining a corresponding cylindrically
shaped passageway 154 therein, the defining walls of which snugly
engage the needle 115b. The needle cover member 152 has a
rearwardly outwardly flaring portion 152b which engages around the
front end portion of the infusion liquid-receiving connector 150
(FIG. 24).
The needle cover 152 has a nose portion 152c which has a generally
spherically shaped cavity 156 therein in which is located the
spherically shaped protuberance 158 of a catheter holding member
160. The catheter holding member 160 is a tubular member having an
open-ended passageway 162 therein extending the full length of the
catheter holding member 160. The catheter holding member 160 has a
portion 160a projecting forwardly of the protuberance 158 and the
nose portion 152c of the needle cover member 152, and a portion
160b extending rearwardly from the protuberance 158 within the
cylindrical chamber 154 of the needle holding member 152. The rear
portion 160b of the catheter holding member 160 passes within the
needle 115b and forms an abutment which prevents the expulsion of
the catheter 12 from the needle when liquid is forced in and
through the barrel 115a when the same is connected to the syringe
unit 129. The beveled tip 12' of the catheter forms a clearance
space 161 between the tip of the catheter 12 and the confronting
open end of the rear portion 160b of the catheter holding member
160 through which air and liquid can pass into the open-ended
passageway 162 in the catheter holding member. The catheter holding
member 160 and the needle cover member 152 are removed as a unit
from the needle after air has been expunged from the barrel 115a
and catheter injection is to be initiated.
The manner in which the initially dry catheter injection device 112
is used can be best explained as follows. At the point of use, the
package 114 is opened so that the catheter injection device 112 can
be removed therefrom. The syringe unit 129, which is initially
provided with a needle (not shown) attached to the nose portion 127
thereof, is filled with a saline solution (or other suitable
sterile injection fluid) by puncturing the soft cap of a saline
solution containing a bottle or the like (not shown) with the
syringe needle and drawing the saline solution into the chamber
129' of the syringe unit by withdrawing the plunger stem 129b from
the chamber. Air is then expunged from the syringe unit in the
usual way by pointing the needle upwards so all of the air rises to
the top of the chamber and then depressing the plunger stem to
drive air and some saline solution from the needle. The needle is
then withdrawn from the nose portion 127 of the syringe unit and
the neck 121 of the catheter injection device 112 is inserted in
place within the nose portion 127 of the syringe unit 129 to
replace the needle removed therefrom. The plunger stem 129b of the
syringe unit 129 is then again depressed to force saline solution
through the barrel 115a and the needle 115b of the catheter
injection device 112 while the needle is pointed upwards to drive
the air from the catheter injection device. The catheter holding
member 160 then acts to prevent ejection of the catheter 12 from
the needle 115b as previously indicated. The assembly of the
catheter holding member 160 and the needle cover member 152 may
then be removed so that further depression of the plunger stem 129b
of the syringe unit 129 will impel the catheter 12 through the
needle into the blood vessel involved. After the catheter 12 is
fully injected into the blood vessel and withdrawn the desired
distance, the catheter 12 may be removed from the needle 115b and
securely anchored within the infusion liquid-receiving connector
150 which is then attached to the connector 40 (FIG. 13) at the end
of an infusion bottle assembly in the same manner previously
described in connection with the other embodiments of the
invention. Alternatively, as previously indicated, the rear end of
the catheter 12 can be left in its sealed position within the rear
end of the needle 115b and the neck 121 of the barrel 115a attached
to the infusion bottle assembly connector 40.
The next embodiment of the invention to be described is a catheter
injection device secured to an infusion bottle assembly before
injection of the catheter, and wherein the liquid from the infusion
bottle assembly is used as the catheter impelling fluid and
infusion of the liquid into the blood vessel may begin immediately
after injection of the catheter into the patient without any
additional operations except for the adjustment of the pinch clamp
of the infusion bottle assembly to control the rate of flow of the
infusion liquid.
THE EMBODIMENT OF THE INVENTION OF FIGS. 27-34
A catheter injection device 164 is shown in FIGS. 27-34 initially
packaged in a sterilized state in a suitable transparent container
or bag 165 made of a transparent synthetic plastic sheet material
in which the device may be gas sterilized in a conventional way.
The catheter injection device 164 includes a catheter containing
body assembly 166 comprising a main tubular body portion 166a which
may be made of a suitable synthetic plastic tubing. The rear end of
the tubing terminates in a bulb-like portion 166b, also made of a
synthetic plastic material, which is the fluid pressure applying
means of the catheter injection device 164. The catheter containing
body assembly further includes a hollow needle hub 168 which is
somewhat larger than the tubing 166a and over which hub the tubing
is securely anchored. A needle 166c is anchored within the hub 168.
The needle lumen 170 forms a continuation of an open-ended
passageway 174 within the tubing 166a. The catheter 12 extends
through the passageway 174 and part of the length of the needle
166c. Where the length of catheter desired is longer than the
distance between the bulb-like portion 166b of the catheter
containing body assembly 166 and a point near the forward end of
the needle 166c, the catheter 12 is coiled up within the bulb-like
portion 166b.
The bulb-like portion 166b is most advantageously a member having a
dome-shaped depressible wall 175 joining a generally cylindrical
side wall 177 through a thickened annular portion 179. The tubing
166a extends within an extension 180 of the cylindrical wall 177
where the tubing communicates with a chamber 182 within the
bulb-like portion 166b. A short tubular section 184 communicates
with the chamber 182 and forms a nose portion for snugly receiving
the connector 40 at the end of the infusion bottle assembly 39.
The depressible dome-shaped wall 175 when depressed snaps into an
inverted shape as shown in FIG. 31, so that once the bulb is
compressed, the depressed wall 175 remains collapsed to avoid the
possibility of creating a negative pressure in the catheter
injection device which could draw air into the device after the
catheter 12 has been injected into the patient by depression of the
wall 175 and the needle 166c is withdrawn from the blood vessel
involved.
The end of the needle 166c carries a needle cover 185 to which is
attached a tubular catheter holding member 187 which has the same
construction and function as the aforesaid described catheter
holding member 160 referred to in connection with the description
of the embodiment of the invention shown in FIGS. 23-26. The base
portion of the needle 166c is initially tightly enveloped by the
nose portion 190 of an infusion liquid-receiving connector 189
which has a hollow cylindrical rear portion 191 which fits within
the front end of a needle retraction sleeve 194. The rear end of
the needle retraction sleeve 194 has a tapered portion 194a which
defines an opening 196 into a cylindrical space 199 within the
sleeve 194. The tubing 166a fits with a slide friction fit into the
opening 196. The needle hub 168 with the tubing 166a thereover
makes a slide friction fit within the sleeve 194. When the catheter
injection device is packaged, however, the needle hub 168 is
positioned from the infusion liquid-receiving connector 189, as
best shown in FIGS. 27 and 29.
As best shown in FIG. 34, the internal construction of the
connector 189 resembles that of the front portion of the infusion
liquid-receiving connector utilized in the other embodiments of the
invention. Thus, the cylindrical rear portion 191 of the connector
189 has a cylindrical opening 200 for snugly receiving the end of
the connector 40 of the infusion bottle assembly 39. Connector 189
is also provided with a recess 202 for receiving the outermost
enlarged portion 12b of the rear end of the catheter 12. The nose
portion 190 of the connector 189 has a passageway 206 therein which
is somewhat smaller in size then the first enlargement 12a at the
end of the catheter 12 and of the needle 166c.
To connect the catheter injection device to an infusion bottle
assembly, the package 165 is opened and the end portion thereof
including the bulb-like portion 166b is removed from the package
and the projecting nose portion 184 thereof is connected to the
connector 40 at the end of the infusion bottle assembly 39 as best
shown in FIG. 28. To prepare the catheter injection device for use,
while the rest of the catheter injection device is left in the
package 165, the package with the device therein is picked up and
held so that the tip of the needle points upwardly, and the pinch
clamp 46 of the infusion bottle assembly is released to permit
infusion liquid to pass entirely through the catheter injection
device and drain into the package to expunge air from the device.
The pinch clamp is then tightened to stop the flow of infusion
liquid.
When the catheter injection device is ready to be used for catheter
injection, the needle cover 185 and the catheter holding member 187
carried thereby are removed by pulling the same from the end of the
needle. The needle 166c is then inserted into the blood vessel
involved after a tourniquet has been applied in the usual manner
for catheter injection and the depressible wall 175 of the
bulb-like portion 166b is depressed to inject the catheter 12 into
the blood vessel involved.
There are two ways in which the catheter injection device now can
be utilized for feeding of infusion liquids. In the more commonly
used application of the invention, such as intravenous feeding and
blood transfusions it is desired to have infusion feeding through
the entire assembly of the catheter injection device described.
This use requires a full ejection of the catheter so a liquid tight
seal is formed between the enlarged end of the catheter and the
connector 189. After withdrawal of the needle from the patient, the
user grasps the needle retraction sleeve 194 in one hand and pulls
on the tubing 166a to bring the needle hub portion 168 closer to
the rear of the sleeve 194 where the tip of the needle is retracted
within the connector 189. The assembly of the connector 189 and the
sleeve 194 may then be taped to the patient's arm or other portion
of the body where catheter injection has occurred, and infusion
feeding proceeds by once again releasing the pinch clamp to the
extent necessary to provide the proper feeding rate. The resumption
of flow of infusion fluid through the bulb-like portion 166b will
generally cause the depressed wall 175 thereof to return to its
initial convex shape if it has not already been pushed into this
shape in the manner described.
The second application of the catheter injection device illustrated
is one wherein all the components making up this device except the
catheter 12 and the infusion liquid-receiving connector 189 are to
be disposed of after injection of the catheter 12. In such case,
the connection to the infusion bottle assembly is made through the
connector 189. In such case, the needle 166c is withdrawn from the
blood vessel involved and the needle tip is retracted within the
connector 189 in the same manner previously described. The
connector 189 and the sleeve 194 are then grasped and squeezed so
that the assembly of the catheter, connector and sleeve are held
together as a unit. Then, the tubular body portion 166a is pulled
so the needle 166c attached thereto is pulled over the enlarged end
of the catheter as shown in FIG. 33 and is removed from the sleeve
194. The sleeve 194 then acts like the catheter holding skirt of
the infusion liquid-receiving connectors of the previously
described embodiments of the invention by preventing the catheter
from dropping upon contaminating surfaces. The catheter is then
pulled fully into the connector 189 where it is drawn into its
extreme position therein, as shown in FIG. 34, and the sleeve 194
is pulled from the connector 189 and thrown away. The rear
cylindrical portion 191 of the connector 189 is then connected to
the connector 40 of the infusion bottle assembly also shown in FIG.
34.
The catheter injection device 164 could be modified so the
bulb-like portion 166b is eliminated and the device integrated with
the infusion bottle assembly tube 43 so the tubular body portion
166a forms a continuation of the tube 43. The bulb-like portion
166b can be merely a collapsible portion of the tube 43 or a
collapsible drip chamber 43' for the infusion bottle (see FIG. 28)
with a shut-off valve provided above the same (not shown).
It is apparent that the various embodiments of the present
invention provide an exceedingly effective, easy to use, and
relatively inexpensive means for injecting catheters into blood
vessels. As previously indicated, the same principles of the
invention utilized in the injection of catheters by liquid into
blood vessels can be applied in injecting catheters or other slim
elongated members into other passageways of the body with liquid or
air.
It should be understood that numerous modifications may be made in
the most preferred forms of the invention described without
deviating from the broader aspects of the invention.
* * * * *