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BACKGROUND OF THE INVENTION
The present invention relates to intravenous catheter placement assemblies
and, more particularly, to needle-inside, catheter placement assemblies
having axial and rotational alignment means.
Catheter placement assemblies of the needle-inside type are well known in
the prior art. U.S. Pat. No. 3,312,200 granted to M. Eisenberg on Apr. 4,
1967 discloses such a catheter placement assembly. U.S. Pat. No. 3,809,081
granted to J. Loveless on May 7, 1974 discloses such a catheter placement
assembly having an obturator threadably connected to the catheter hub.
U.S. Pat. No. 3,589,361 granted to D. Loper on June 10, 1968 discloses
such a catheter placement assembly having axially movable winged insertion
means disposed on the catheter. U.S. Pat. No. 3,769,975 granted to M.
Nimoy, et al. on Nov. 6, 1973 discloses such a catheter placement assembly
having a catheter unit comprising a catheter, winged catheter insertion
means, flexible tubing and a tube hub.
An advantage of the Nimoy catheter placement assembly is that its tube hub
is substantially spaced from the venipuncture site, thereby allowing the
catheter to be securely attached to the patient at that site and allowing
possible infection causing connections to an intravenous solution set to
be made remote from the wound.
A major disadvantage of the Nimoy assembly is that axial and rotational
alignment of the needle and catheter unit is difficult to maintain both
prior to and during placement of the catheter into a patient. Nimoy
attempts to solve this problem by the use of a removable plastic sleeve
removably mounted on the flexible tubing. Loper discloses that flexing of
his winged insertion means grasps both the catheter and needle during
venipuncture. U.S. Pat. No. 3,537,451 granted to D. Beck, et al. on Nov.
3, 1970 discloses still another winged catheter insertion means which
grasps both the catheter and their two-diametered needle during
venipuncture.
Unfortunately, these prior art assemblies do not maintain axial or
rotational alignment of the needle and catheter unit prior to placement of
the catheter into the patient. Thus, proper axial or rotational alignment
of the needle and catheter must be made by the user of the assembly just
prior to venipuncture. Accordingly, it will be apparent that such a
catheter placement assembly providing axial and rotational alignment of
the needle and catheter unit thereof at all times would be advantageous
and desirable.
SUMMARY OF THE INVENTION
Therefore, it is the primary object of this invention to provide a
needle-inside, catheter placement assembly wherein the needle and catheter
unit thereof are maintained in axial and rotational alignment at all times
during their assembling.
In accordance with these and other objects, there is provided by the
present invention a needle-inside, catheter placement assembly having a
spliced, two-part needle mechanically interlocked with complementary
portions of the catheter unit thereof to maintain their axial and
rotational alignment at all times during their assemblage.
BRIEF DESCRIPTION OF THE INVENTION
Other objects and attendant advantages will be obvious to those skilled in
the art by reading the following detailed description in connection with
the accompanying drawing wherein like reference characters designate like
or corresponding parts throughout the several figures thereof and wherein:
FIG. 1 is a perspective view of a preferred embodiment of the
needle-inside, catheter placement assembly of the present invention.
FIG. 2 is an exploded view of the assembly of FIG. 1 showing the catheter
unit and the needle thereof,
FIG. 3 is a cross-sectional view of a portion of the assembly of FIG. 1,
FIG. 4 is a cross-sectional view along the line 4--4 in FIG. 3 of the
assembly thereof,
FIG. 5 is an enlargement of a portion of FIG. 3,
FIG. 6 is another embodiment of the needle of the present invention,
FIG. 7 is a cross-sectional view of the needle of FIG. 6 incorporated into
a catheter placement assembly viewed similarly as in FIG. 4,
FIG. 8 is a cross-sectional view along the line 8--8 in FIG. 7 of the
assembly thereof,
FIGS. 9-11 are further embodiments of the needle of the present invention,
and
FIG. 12 is a cross-sectional view of the needle of FIG. 9 incorporated into
a catheter assembly viewed similarly as in FIG. 8.
DETAILED DESCRIPTION OF THE INVENTION
Referring to the drawing, there is shown in FIG. 1 a preferred embodiment
of the needle-inside, catheter placement assembly 9 of this invention.
Catheter placement assembly 9 comprises a needle 11 having its proximal
end attached to a needle hub 12 and a beveled, sharpened distal end 13.
As shown in FIG. 2, needle 11 has a first portion 14 extending a
predetermined distance from distal end 13 towards and joined to a second
portion 15 which extends to the proximal end of needle 11. The distal
portion of second portion 15 is in juxtaposition with the proximal portion
of first portion 14. Preferably, first portion 14 is made of hollow,
open-ended, stainless steel tubing, while second portion 15 can be a rod
or tube of any material that will allow first portion 14 to be suitably
attached thereto, e.g., by bonding, soldering, or welding. Advantageously,
juxtaposed first and second portions 14, 15 provide a nonsymmetrical
feature by which needle 11 can be mechanically locked in catheter
placement assembly 9.
As seen in FIG. 6, needle 11 can also have its first and second portions
joined or captured in juxtaposition by a joint 16. The distal end of
second portion 15 can be encapsulated within joint 16 as shown, or it may
extend from the distal end of joint 16, if so desired. Optionally, as
shown in FIGS. 9-11, joint 16 can have projections 17, 18, 19 of various
configurations projecting from its distal end. Joint 16 can be made of
metal or plastics such as polyvinylchloride, polypropylene, or
polyurethane.
Joint 16 can mechanically capture first and second portions 14, 15 or they
can be bonded to joint 16. Alternatively, joint 16 can be insert molded
around first and second portions 14, 15. Likewise, second portion 15 can
be molded as a unitary extension of a molded joint 16, if so desired.
Catheter placement assembly 9 further comprises a catheter unit 21 having a
flexible plastic catheter 23, winged catheter insertion means 25, flexible
tubing 27 and tube hub 29. Catheter 23 is distally tapered at its distal
end and can be made of any biocompatible flexible plastic material such as
polyethylene, polypropylene, polytetrafluoroethylene or polyvinylchloride.
The inner diameter of catheter 23 is substantially identical to the outer
diameter of first portion 14 of needle 11.
Winged catheter insertion means 25 has a pair of flexible wings 31, 32
which, preferably, have a weakened portion or groove 33 adjacent a tubular
portion 34 which has a lumen therethrough. Preferably, winged catheter
insertion means 25 can be made of polyvinylchloride, but any other
material that will enable wings 31, 32 to be flexed outwardly for aiding
in the insertion of catheter 23 into the patient and subsequently
downwardly, if necessary, for taping to the patient's body can be used.
As best seen in FIG. 3, flexible wing members 31 and 32 are reduced in
width proximate their connection with tubular portion 34. In addition wing
members 31 and 32 have a cut out portion proximate the proximal end of
tubular portion 34. This reduction in width and these cut out portions
facilitate folding or bending upward of wing members 31 and 32, and also
make it much easier to attach flexible tubing 27 to tubular portion 34.
The proximal end of catheter 23 is in fluid communication with the distal
end of the lumen of tubular portion 34. As shown in FIG. 1, catheter 23
has an outer diameter substantially equal to the inner diameter of the
lumen of tubular portion 34 and is inserted therein. However, it will be
readily apparent that tubular portion 34 can be designed to receive
catheter 23 on its outer diameter, if so desired.
The distal end of flexible tubing 27 is in fluid communication with the
lumen of tubular portion 34 at its proximal end. As shown in FIG. 1,
tubular portion 34 is inserted into flexible tubing 27, but it will be
readily apparent that flexible tubing 27 can be inserted into tubular
portion 34, if so desired. Preferably, flexible tubing 27 can be made of
clear polyvinylchloride or polyurethane and has an inner diameter greater
than the inner diameter of catheter 23.
The proximal end of flexible tubing 27 is connected in fluid communication
to tube hub 29 which has a lumen 37 therethrough. Tube hub 29 is,
preferably, made of polyvinylchloride, ABS copolymers or polycarbonate
and, preferably, has a recess or female luer adapter at its proximal end.
A collar 39 having ears 40, 41 extends outwardly from the proximal endwall
of tube hub 29.
As best seen in FIGS. 5, 8 and 12, the lumen of tubular portion 34 of
winged catheter insertion means 25 provides means complementary to the
juxtaposed first and second portions 14, 15 of needle 11 by which catheter
unit 21 and needle 11 can be mechanically interlocked in axial and
rotational alignment at all times while assembled. As seen in FIG. 5, the
lumen of tubular portion 34 is enlarged to a FIG. 8 at its proximal end to
form a recess complementary to the distal end of second portion 15 of
needle 11. Alternatively, as seen in FIG. 8, the proximal end of the lumen
of tubular portion 34 can enlarged to receive the entire joint 16, where
needle 11 has such a joint, or as seen in FIG. 12, the lumen of tubular
portion 34 can receive first portion 14 of needle 11, while an associated
aperture at the proximal end of tubular portion 14 receives a projection
17 of joint 16.
On assembly, needle 11 is inserted into catheter unit 21 until the
complementary means associated with the lumen of tubular portion 34 and
the juxtaposed first and second portions 14, 15 of needle 11 meet and
mechanically interlock. When that mechanical interlock has been achieved,
the bevel at distal end 13 of needle 11 will be facing upwardly and
projecting from the distal end of catheter 23 a chosen predetermined
distance and the distal end of needle hub 12 will be situated within the
lumen of tube hub 29. Preferably, the proximal end of first portion 14 of
needle 11 will be situated within flexible tubing 27. The mechanical
interlock will also prevent further distal movement of needle 11 with
respect to catheter unit 21. Rotational misalignment or rotational
movement of needle 11 with respect to catheter unit 21 is likewise
prevented.
In use, it is anticipated that the catheter placement assembly 9 will be
inserted into a patient by pinching flexible wings 31, 32 together to
provide a finger grip and inserting the distal end of needle 11 and
catheter 23 into the patient's vein in accordance with conventional
venipuncture techniques well known in the medical practice. After the vein
has been entered, if first portion 14 of needle 11 is hollow, it will
allow blood to flow, or flashback, to flexible tubing 27 where it will
readily be visible to indicate that the vein has been entered.
After the venipuncture has been achieved, the person inserting the assembly
into the patient continues to grip wings 31, 32 in one hand and uses the
other hand to disconnect needle hub 12 from the tube hub 29. Needle 11 is
then withdrawn from catheter unit 21 and discarded. Catheter 23 is fully
inserted into the vein, wings 31, 32 are then taped to the patient, a
safety loop formed with flexible tubing 27 and an intravenous solution set
attached to tube hub 29 in accordance with conventional techniques of the
medical practice.
Having described the invention in specific detail and exemplified the
manner in which it may be carried into practice, it will now be readily
apparent to those skilled in the art that innumerable variations,
applications, modifications and extensions of the basic principles
involved may be made without departing from its sphere or scope.
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