IV catheter abstract
A device for delivering an IV catheter to an IV infusion site is
disclosed. The device includes a cylindrical housing adapted to
fit into the hand of the clinician. A catheter assembly is disposed
in the housing and can be advanced to an extended position and retracted.
The catheter assembly includes a needle adapted to be inserted into
the vein and the catheter is mounted on the needle to allow the
catheter to be removed at will. The catheter assembly is rotated
as the needle is inserted into the vein. Preferably the catheter
assembly is rotated during the insertion of the needle and catheter.
After the needle and catheter are inserted into the vein, the needle
is retracted into the housing leaving the catheter in place. The
housing and the needle can now be discarded.
IV catheter claims
I claim:
1. A device for establishing an IV catheter by a clinician comprising:
a housing sized and shaped to fit in the hand of the clinician;
a catheter assembly including a catheter member with a front portion
adapted to be inserted into the vein of a patient; and a control
member adapted to reciprocate said catheter assembly within said
housing between a retracted position in which said catheter assembly
is completely contained in said housing and an extended position
in which said catheter member extends outwardly of said housing.
2. The device of claim 1 wherein said catheter member is removably
attached to said catheter assembly so that it can be removed in
said extended position.
3. The device of claim 1 wherein said catheter assembly includes
a needle member including a needle which extends outwardly of said
housing when said catheter member is in the extended position, said
needle being arranged and constructed for insertion in the vein,
said catheter member being telescopically associated with said needle
member.
4. The device of claim 3 wherein said catheter member is removably
attached to said needle member.
5. The device of claim 1 wherein said catheter member and said
housing cooperate to rotate said about a longitudinal axis as said
catheter assembly is reciprocated by said control member.
6. The device of claim 1 further comprising locking means for locking
said catheter assembly with respect to said housing.
7. The device of claim 6 wherein said locking means is adapted
to lock said catheter assembly in said retracted position.
8. The device of claim 6 wherein said locking means is adapted
to lock said catheter assembly in said extended position.
9. The device of claim 1 further comprising disabling adapted to
selectively disable said catheter assembly within said housing to
prevent said catheter assembly for being moved extend outside said
housing.
10. A device adapted to establish a catheter for providing IV infusions
to a patient through a vein, said device comprising: a cylindrical
housing having a front end, a rear end and a cylindrical surface
extending therebetween; a catheter assembly including a needle member
with a needle and a catheter member removably attached to said needle
member and telescopically arranged on said needle; and control means
for reciprocating said catheter assembly between a retracted position
wherein said catheter assembly is completely disposed within said
cylindrical and an extended position wherein said needle and said
catheter member are operative to be inserted in the vein.
11. The device of claim 10 wherein said catheter assembly further
comprises a piston, said needle member and said catheter member
being connected to said piston.
12. The device of claim 10 further comprising rotating means adapted
to rotate said catheter assembly about an axis as said catheter
assembly is reciprocated by said control means.
13. The device of claim 10 further comprising a first locking means
for locking said catheter assembly in said retracted position.
14. The device of claim 10 further comprising a second locking
means for locking said catheter assembly in said extended position.
15. The device of claim 10 further comprising control disabling
means adapted to disable said control means to prevent said catheter
assembly from being moved to extend outside said cylindrical housing.
16. The device of claim 10 further comprising biasing means for
biasing said catheter assembly toward said retracted position.
17. An IV catheter delivery device comprising: a cylindrical housing
with a housing front end, a housing rear end and a cylindrical housing
extending therebetween; a catheter assembly disposed in said barrel
and including a catheter member with a catheter front end adapted
to be inserted in the vein of a patient; a control member adapted
to selectively move said catheter assembly from a retracted position
wherein said catheter front end is disposed completely within said
cylindrical housing and an extended position wherein said catheter
front end extends outwardly of said housing front end; and biasing
means for biasing said catheter assembly toward said retracted position.
18. The device of claim 17 further comprising means for rotating
said catheter assembly as said cardiac assembly is advanced toward
said extended position.
19. The device of claim 17 further comprising a needle member having
a needle adapted to be inserted into a vein, said catheter member
being telescopically mounted on said needle.
20. The device of claim 17 wherein said catheter front end is flexible.
IV catheter description
BACKGROUND OF THE INVENTION
[0001] a. Field of Invention
[0002] This invention pertains to a device used to establish an
IV catheter in a patient. More particularly, the invention pertains
to a safety infusion device that includes a handpiece used to store
and to selectively extend the IV catheter so that it can be introduced
into the patient, the handpiece being constructed and arranged to
insure that the IV catheter and the so-called underlying needle
can be retracted into the barrel at will to protect clinicians from
accidental needlesticks.
[0003] b. Description of the Prior Art
[0004] IV infusion is one of the most widely used procedures performed
in hospitals and other healthcare provider sites. These infusions
involve continuously injecting one or more liquids into the veins
of a patient to achieve various results. Simple infusion systems
may consist of a catheter inserted into the vein and secured to
the patient, a pole holding a bottle or bag used as the source of
the liquid, a flexible tube feeding the liquid to the catheter either
directly, or though some kind of fluid control device. More complex
devices include fusion pumps that can deliver fluids to the patient
at carefully metered rates using specific profiles.
[0005] However, independent of which infusion system is used, the
IV catheter must first be established. Many different devices are
used to perform this step. A popular system consists of a cylindrical
receptacle. A hollow steel needle is attached co-axially to one
end of the receptacle. A hollow catheter is mounted on the steel
needle in a coaxial arrangement. The hollow catheter has a shaft,
preferably made of a plastic material and terminating in a standard
connector, such as a male Luer lock. A spring is disposed in the
receptacle so that when a latch mounted on the receptacle is activated,
the steel needle separates from the catheter and is snapped into
the receptacle. Once the steel needle is snapped into the receptacle,
it is locked in place so that it cannot be extended and reused.
Since the needle and the catheter are normally exposed, a protective
cap is generally provided over the needle.
[0006] Using this type of system a catheter is established as follows.
First, the clinician finds and preps a proper site on the skin.
Next, the system is removed from a sealed enclosure, and its protective
cap is removed. The needle and the catheter mounted thereon are
inserted through the skin until the tip of the needle and the catheter
reaches a predetermined site. The catheter is then secured with
the forefinger of one hand and the latch is activated to cause the
needle to snap into the receptacle before a needlestick. The receptacle
with the captured needle is then disposed. Systems of this kind
are available from Becton Dickinson of Franklin Lakes, N.J.; Johnson
& Johnson Medical, Inc. of Arlington, Tex., and described in
the following patents, incorporated herein by reference:
1 5688249 5520654 5304136 5700250 5141497 5683365 5755709
.sup. D378405 5348544 5749857 5755709 5411486 5792122
5795339 5676658 .sup. D381418 5690619
[0007] However, these systems are not satisfactory for several
reasons. As is well known in the art, the catheter has to extend
into a vein and must be oriented properly in order for it to be
effective. However, very often clinicians cannot find the proper
vein or the proper infusion site on their first try. Therefore,
after the needle and catheter have been inserted, the whole system
becomes contaminated. Often, before the system can be reinserted,
a new site has to be found and prepared.
[0008] The clinician, especially if she is alone, cannot select
and prepare a new site while holding the contaminated system and
therefore must make a decision on what to do with it. At least one
manufacturer suggests that the system should be discarded. However,
obviously, this is a wasteful step.
[0009] The clinician can also decide to recap the needle and then
place it on a horizontal position. However, this process requires
two hands and is exactly the situation that subjects people to inadvertent
needlesticks.
[0010] Another disadvantage of existing systems is that they normally
require a linear or translational motion of the needle during insertion.
This is disadvantageous because it causes the needle to bend thereby
causing pain to the patient. Moreover, if the needle bends during
insertion, it will miss the vein and the process has to be repeated.
[0011] Commonly assigned application Ser. No. 09/506484 filed
Feb. 17 2000 entitled HAND-PIECE FOR INJECTION DEVICE WITH A RETRACTABLE
AND ROTATING NEEDLE, now ______ and incorporated herein by reference,
discloses an injection device with a barrel from which a needle
is selectively extended and retracted using a translational and
rotational motion for dispensing an anesthetic to a patient.
[0012] Commonly assigned patent application Ser. No. 09/745751
filed Dec. 21 2000 entitled METHOD OF PERFORMING AN INJECTION
USING A BI-DIRECTIONAL ROTATIONAL INSERTION TECHNIQUE, now ______
and incorporated herein by reference discloses the advantages of
using a bi-directional rotational technique for dispensing anesthetics.
OBJECTIVES AND SUMMARY OF THE INVENTION
[0013] An objective of the present invention is to provide a system
for establishing a catheter which overcomes the above-mentioned
disadvantages.
[0014] A further objective is to provide a system that can be used
easily by clinicians.
[0015] Other objectives and advantages will become apparent from
the following description.
[0016] Briefly, the subject application pertains to a device for
establishing an IV catheter by a clinician. The device includes
a housing sized and shaped to fit in the hand of the clinician;
a catheter assembly including a catheter member with a front portion
adapted to be inserted into the vein of a patient; and a control
member adapted to reciprocate the catheter assembly within said
housing between a retracted position in which said catheter assembly
is completely contained in said housing and an extended position
in which said catheter member extends outwardly of said housing.
A catheter member can be removably attached to the catheter assembly
so that it can be removed in the extended position.
[0017] The catheter assembly includes a needle member with a needle
extending outwardly of the housing when the catheter member is in
the extended position. The needle is arranged and constructed for
insertion in the vein with the catheter member being telescopically
associated with the needle member. The catheter member is removably
attached to the needle member.
[0018] In one embodiment the catheter member and the housing cooperate
to rotate the catheter assembly about a longitudinal axis as the
catheter assembly is reciprocated by said control member.
[0019] The device also can include locking means for locking the
catheter assembly or the needle after the catheter replacement with
respect to the housing. These locking means can be adapted to lock
the catheter assembly in either the retracted position or the extended
position. In addition, the control member can be disabled by the
use of the same, or a different locking means so that after the
catheter element is properly established, the needle used to establish
the catheter cannot be reused.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 shows a sectional side view of a device in a retracted
position constructed in accordance with this invention;
[0021] FIG. 2 shows a sectional side view of the device of FIG.
1 in the extended position;
[0022] FIG. 3 shows a sectional side view of the device of FIG.
1 in the extended position with the catheter partly removed;
[0023] FIG. 4 shows a sectional side view of the device of FIG.
1 in the extended position with the catheter completely removed;
[0024] FIG. 5 shows a sectional side view of the device of FIG.
1 with the needle retracted and the catheter removed;
[0025] FIG. 6 shows an orthogonal view of a barrel for the device
of FIG. 1;
[0026] FIG. 7 shows an orthogonal view of a control button;
[0027] FIG. 8 shows an orthogonal view of the piston for the device
of FIG. 1;
[0028] FIG. 9 shows a side view of the needle member for the device
of FIG. 1; and
[0029] FIG. 10 shows a side view of the catheter for the device
of FIG. 1.
DETAILED DESCRIPTION OF THE INVENTION
[0030] Referring now to the Figures, a device 10 constructed in
accordance with this invention consists of a cylindrical housing
or barrel 12 having an outer surface 14 an inner surface 16 a
front end 18 and a rear end 20. An end piece 22 is attached to the
rear end 20 of the barrel. The barrel 12 defines a cylindrical housing.
[0031] As shown in FIG. 1 a catheter assembly 21 is provided in
the barrel 12. This catheter assembly is biased toward a retracted
position by a coil spring 23.
[0032] FIGS. 6 and 6A show more details of the barrel 12. It includes
a longitudinal slot 24. The slot 24 is formed with two ledges 26
extending along the sides of the slot 24. These ledges terminate
at a gap near the front end 18 to define a front key 28. In addition,
gaps in the ledges 26 near the rear end 20 define a rear key 30.
Two radial ribs 32 form an outer surface 14 of the barrel 12 to
provide a better grip. At the rear end of the slot 24 a portion
of the barrel is cut to form an arcuate tongue 34. The purpose of
this tongue 34 is described in more detail below. The barrel is
preferably made of a plastic material and is preferably transparent
so that the clinician can see its contents. For example, the barrel
could be made of an acrylic-based multipolymer such as Cyrolite
#GS-90.
[0033] As seen in FIG. 1 the inside surface 16 of the barrel 12
is formed with a helical groove 36. The rear end 20 is threaded.
The front end 18 is formed with an annular end wall 38 with an orifice
40.
[0034] The catheter assembly 21 consists of a piston 50 shown in
detail in FIG. 8 a catheter member 52 and a needle member 54. The
piston is formed of an axle 56 supporting a rear hub 58 a center
hub 60 and a front hub 62. The rear and front hubs 58 62 have approximately
the same radial dimension and they are sized to allow the piston
50 to fit into the barrel 12 with the hubs 58 62 slidingly engaging
the inner surface 16. The axial spacing between the two hubs is
sufficient to stabilize the piston 50 and the elements attached
thereto (and described below) as they reciprocate through the barrel
12. The center hub 60 has a smaller diameter and a somewhat curved
cross section. The circumferential surface of hub 62 is optionally
provided with a knob 64 which is sized and shaped to fit into helical
groove 36. Therefore, as the piston 50 is reciprocated through the
barrel, it is also rotated about its longitudinal axis by the caming
action on the knob 64 as it travels through groove 36.
[0035] Hub 62 also includes a tubular wall 66 disposed about an
end portion 68 of axle 56. The inner surface of the tubular wall
66 is formed with a helical groove 70. The wall 66 and the end portion
68 cooperate to define a female Luer lock 72.
[0036] Details of the needle member 54 are shown in FIG. 9. It
includes a disk 80 a cylindrical body 82 a frustoconical extension
84 and a hollow steel needle 86. These elements are attached to
each other as shown. The disk 80 is sized and shaped so that it
can be introduced into the Luer lock 72. In this manner, the needle
member 54 is firmly attached to the piston 50. The needle member
54 can be secured to the piston 50 by other means as well, for example,
by using an adhesive.
[0037] As best seen in FIGS. 3 and 10 the catheter member 52 is
formed with a hollow substantially cylindrical body 90 with a rear
portion 92 which has a relatively large diameter. The body 90 also
has a front portion 94 which is much thinner than the rest of the
body 90. The body 90 also includes several circumferential ribs
96 forming a grip for the catheter. A portion of one of the ribs
is extended radially to form a tab 98.
[0038] The catheter member 52 is made of a flexible plastic material.
Preferably catheter member 52 is somewhat translucent.
[0039] The catheter member 52 and the needle member 54 are sized
and shaped so that the catheter member 52 fits over the needle member
54 as shown in FIG. 2 with the steel needle 86 extending through
and beyond the front portion 94. Moreover, the rear portion 92 is
sized to form an interference fit with the extension 84. The catheter
member 52 is freely removable by a clinician from the needle member
54. Of course, there is sufficient interference fit provided to
insure that the catheter member 54 does not separate easily from
the needle member without substantial force applied thereto. This
force may be applied to tab 98 as explained in more detail below.
[0040] Finally, the device 10 includes a control member 100 shown
in more detail in FIG. 7. The control member 100 is formed of an
upper body 102 a lower body 104 and an intermediate portion 106.
The lower body 102 is formed with an arcuate surface 108 designed
to conform to the shape of the hub 60 on piston 50. The upper body
102 is formed with two wings 110 112 and a depression 114 defined
therebetween. The depression 114 is sized and shaped to accommodate
the finger of a clinician. The wing 112 is formed with a tab 116
extending downwardly and is sized and shaped to fit into the keys
30 and 32 on barrel 12. The control member 100 is made of a plastic
material.
[0041] The control member 100 is sized and shaped to fit into the
slot 24 with the upper body 102 disposed outside the barrel 12 and
riding on the ledges 26 and the lower body 104 being disposed inside
the barrel with the hub 60 being captured by curved surface 108.
[0042] The device 10 is assembled by attaching the catheter member
52 to the needle element 54 and attaching the needle element to
the piston 50 thereby completing the catheter assembly 21. The
spring 23 and catheter assembly 21 are then inserted through a hole
(not shown) in the rear end 20 of barrel 12. The control member
100 is also mounted on the barrel 12. Next, the end piece 22 thereto
by screwing the same over the threads of the rear end. Preferably
and adhesive is also used to insure that the end piece 22 does not
separate from the barrel. Alternatively, the end piece 22 is attached
to the barrel 12 without any threading action. Once the end piece
is installed, the elements described above are captured by the barrel
(except for the catheter member 52) and cannot be removed without
breakage.
[0043] Initially the elements of the device 10 are arranged in
a closed or retracted position as shown in FIG. 1. Spring 23 has
a diameter which is slightly larger than the diameter of wall 66.
In this retracted position, the spring 23 is expanded and applies
a biasing force between the end wall 38 of the barrel 12 and the
wall 66 on piston 50. The control member 100 is positioned over
the piston 50 with the hub 60 being captured by the curved surface
108.
[0044] The control member 100 is formed so that its tab 116 extends
downwardly in the rear key 32 of slot 26. Moreover the control member
100 is formed and arranged so that as the control member 100 is
shifted to the right to the retracted position, a bottom wall 118
of wing 110 (shown in FIG. 7) comes into contact with the end of
finger 128. The finger 128 being slightly higher, and in effect
pushes the wind 110 slightly upward as well. As a result, the opposite
wind 112 with the tab 116 is pushed downward into the key 30. In
this manner the control member 100 and the catheter assembly 21
is locked into the retracted position. The device 10 is sealed in
a suitable package (not shown) and stored in this position.
[0045] The device 10 is used to establish the catheter member 52
as follows. Typically, an infusion procedure is initiated by a clinician
by selecting and prepping the infusion site. The clinician then
removes the device 10 from its package and holds it in a pinching
grip. In this grip the thumb is positioned on the control member
100 and the remaining fingers being wrapped around the barrel to
stabilize it. The device 10 is sized and shaped so that in this
pinching grip, the pinky finger wraps around the end piece 22.
[0046] The clinician then pushes on the wing 110 axially inward
causing the top body to twist slightly radially inward, and lift
the tab 116 out of rear key 32. This action unlocks the control
member 100. Next, the clinician advances the control member 100
slightly forward. Because the surface 108 captures the hub 60 this
movement forces the whole catheter assembly 21 to move forward as
well. The clinician continues the translation of the control member
100 forward until a portion of the needle 96 extends through the
hole 40 (FIG. 6).
[0047] Next, the clinician positions the device 10 next to the
infusion site with the tip of the needle 86 resting against the
skin. The clinician then continues to advance the control member
100 until it reaches the front key 30. The clinician can lock the
control member 100 and the catheter 21 by pushing the wind 112 inwardly
thereby causing the tab 112 to pivot counterclockwise and engage
front key 30. In this position, a portion of needle member 54 and
most of the catheter member 52 extend out of the barrel 12 as shown
in FIG. 2. This position is the extended position of the device.
[0048] It should be appreciated that as the control member 100
is advanced from the rear key 30 to the front key 30 in a translational
motion through the slot 26 because of the caming action between
the knob 64 and spiral groove 36 the catheter assembly 21 is translated
forward as well from the retracted to the extended position, and
is simultaneously rotated about its longitudinal axis and the longitudinal
axis of the barrel 12. As explained in the above-identified application
Ser. No. 09/506484 filed Feb. 17 2000 and in application Ser.
No. 09/745751 filed Dec. 21 2000 this combined or bidirectional
motion is very advantageous because as the needle 86 penetrates
the skin and the tissues and advances to the vein, its simultaneous
rotation insures that the patient suffers less pain. In addition,
it prevents the needle 86 from bending and insures that the needle
advances precisely in the direction and to the location desired
by the clinician.
[0049] The needle 86 must be advanced sufficiently so that the
front portion 94 is in fluid communication with the vein as well.
The front portion 94 is thin enough so that it slips easily through
the sidewalls of the vein. As discussed above, needle 86 is hollow
and has an opening at its tip. A second opening may be provided
on the needle 86 under the front end 94. When the needle 86 and
front end 84 are inserted into the vein, blood from the vein flows
into the needle 86 and oozes out of this second opening, under the
front end 94. Since the catheter 52 is translucent, this blood is
easily visible to the clinician. Moreover, since the needle 86 is
hollow, some of the blood also flows back in the housing where it
becomes visible as well. This provides confirmation that the needle
86 and the catheter member 52 are properly positioned in the vein.
[0050] If for any reason the clinician has to move to a different
infusion site, he can withdraw the needle from the patient. If this
motion occurs before the control member 100 reached front key 30
then the clinician can merely release the control member 100 and
the catheter assembly 21 is then automatically returned to the retracted
position by the spring 23. If this motion is desired after the front
key 30 is reached, then the clinician must first unlock the control
member from the front key by pressing inwardly on wing 110.
[0051] Once the catheter assembly 21 is returned to its retrieved
position, the device 10 can be rested on a flat surface and the
clinician can go on with other tasks (such as prepping the new site)
without fear of needlesticks even if the needle 86 has been contaminated.
[0052] After the needle 86 and the catheter member 52 are properly
positioned in the vein, the needle 86 is withdrawn as follows. The
clinician shifts his forefinger to rest on the front end 94 of the
catheter member 52. The rest of his fingers are still wrapped around
the barrel 12. In this position, the clinician unlocks the control
member 100 as discussed above and releases it. The spring 23 forces
the needle member 54 to withdraw telescopically and separate from
the catheter 52. The needle member 54 and the piston 50 are then
snapped back to the retracted position. During this motion, the
clinician holds the catheter member 52 in place (i.e., inserted
in the vein). Thus, the clinician needs to use only a single hand
from the beginning of the process until the catheter member 54 is
established in the vein and is separated from device 10. As explained
above, in prior art devices this same operation requires the use
of two hands.
[0053] FIG. 3 shows the catheter member 52 being removed from the
needle member 54.
[0054] FIG. 4 shows the catheter member 52 being separated from
the rest of the device 10.
[0055] FIG. 5 shows the catheter assembly 21 without the catheter
member 52 in the retracted position.
[0056] Once the device 10 is in the retracted position of FIG.
5 it can be disposed. The catheter member 52 can be connected to
a standard IV tube by attaching to a standard Luer lock, or by using
other well known means.
[0057] Importantly, in many instances the clinician may want to
insure that once its catheter member 54 has been properly established,
the device 10 is not reused in any way and that the needle member
54 stays in the retracted position. This is accomplished by providing
a disabled condition for the device in which the control member
100 is inoperative and cannot be used to advance the needle. One
manner in which this feature can be implemented is to make the intermediate
portion 106 of the control member 100 frangible. Then, once the
catheter member 52 is properly established in the vein, the top
body 102 is broken off from the bottom body 104. Once this step
is completed, the piston 50 and the needle member 54 are trapped
inside the barrel 12 and cannot be removed without breaking the
barrel.
[0058] The device may be used in a different manner as well. For
example, if the clinician does not want to take advantage of the
simultaneous translation and rotation of the needle member 54 he
can advance the catheter assembly 21 from the retracted to the extended
position first, and then with the needle member being fully extended,
he can start inserting the needle 86 through the skin toward the
selected vein. For this type of operation, since the rotation of
the needle 86 is not required, the knob 64 and the groove 26 may
be omitted.
[0059] Other modifications may be made to the device 10 as well.
For example, the means for locking the control member 100 either
in the retracted position, the extended position, or both, may be
omitted.
[0060] While the invention has been described with reference to
several particular embodiments, it is to be understood that these
embodiments are merely illustrative of the principles of the invention.
Accordingly, the embodiments described in particular should be considered
as exemplary, not limiting, with respect to the following claims.
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