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United States Patent |
5,766,154
|
Wilson
,   et al.
|
June 16, 1998
|
Vascular access device
Abstract
The present invention is directed to a vascular access device for
introducing a catheter in a blood vessel using a guide advancing
mechanism. The device generally comprises a housing, an introducer needle,
a catheter, a guide wire and an actuating means. The introducer needle of
the vascular access device is used to penetrate the blood vessel. The
actuating means is then initiated and the guide wire is steadily propelled
into the blood vessel. Once the guide wire is in place, the catheter,
which is concentrically placed over the introducer needle and guide wire,
is uncoupled from the vascular access device and guided into the blood
vessel by the guide wire.
Inventors:
|
Wilson; Jay (Portola Valley, CA);
Hanna; Shawn (Woodside, CA);
Chen; Jeff (Mountain View, CA);
Hall; Robert C. (Palo Alto, CA);
Bryant; Teddy (San Francisco, CA)
|
Assignee:
|
Becton Dickinson and Company (Franklin Lakes, NJ)
|
Appl. No.:
|
722788 |
Filed:
|
September 27, 1996 |
Intern'l Class: |
A61M 005/178 |
Field of Search: |
128/657,772
604/164,165,95,157,156
|
References Cited
U.S. Patent Documents
4068659 | Jan., 1978 | Moorehead | 128/214.
|
4417886 | Nov., 1983 | Frankhouser et al. | 604/53.
|
4747831 | May., 1988 | Kulli | 604/110.
|
4894052 | Jan., 1990 | Crawford | 604/63.
|
5312361 | May., 1994 | Zadini et al. | 604/165.
|
5415177 | May., 1995 | Zadini et al. | 128/772.
|
5425718 | Jun., 1995 | Tay et al. | 604/165.
|
5480388 | Jan., 1996 | Zadini et al. | 604/165.
|
5527290 | Jun., 1996 | Zadini et al. | 604/165.
|
5527291 | Jun., 1996 | Zadini et al. | 604/165.
|
Primary Examiner: Rimell; Sam
Assistant Examiner: Yeh; Luke J.
Attorney, Agent or Firm: Lee; Eric M.
Claims
What is claimed and desired to be secured by a United States Letters Patent
is:
1. A vascular access device for introducing a catheter into a blood vessel
of a patient comprising:
a housing having a proximal end and a distal end;
an introducer needle having a proximal end and a distal end, the proximal
end of the introducer needle being attached to the distal end of said
housing, the introducer needle being substantially hollow and having a tip
at its distal end;
a flexible wire having a proximal end and a distal end, the proximal end
secured within said housing and the distal end extending within the
introducer needle;
actuating means disposed within said housing for advancing the flexible
wire beyond the tip of the introducer needle and into the blood vessel,
wherein the actuating means comprises a spring, a disk and a trigger, and
wherein the spring is attached to the disk and the disk is attached to the
flexible wire, wherein the expansion of the spring is capable of being
prevented by the force of the trigger against the disk; and
means for receiving a catheter such that said catheter is concentrically
fitted over the introducer needle and secured to said housing.
2. A vascular access device as defined in claim 1 wherein said means for
receiving a catheter comprises a nose secured to the distal end of said
housing.
3. A vascular access device as defined in claim 1 wherein said housing is
substantially cylindrical in shape.
4. A vascular access device as defined in claim 1 wherein the trigger
further comprises a trigger arm, a trigger pin, and a trigger shaft, and
wherein the trigger shaft engages the disk selectively preventing the
expansion of the spring, the actuating means being initiated by depressing
the trigger arm wherein the trigger pivots about the trigger pin thus
disengaging the trigger shaft from the disk permitting the spring to
expand and advancing the wire.
5. A vascular access device for introducing a catheter into a blood vessel
of a patient comprising:
a housing having a proximal end and a distal end;
an introducer needle connected to the housing;
a wire movably secured within the housing;
a plunger disposed within the housing connected to the wire;
a resilient member disposed within the housing and engaging the plunger;
and
a pivotable lever which engages the plunger and prevents the resilient
member from advancing the plunger axially in a first position and which
pivots to a second position to disengage from the plunger to propel the
wire past the beveled tip of the introducer needle and into the blood
vessel.
6. A vascular access device as-defined in claim 5 wherein the plunger
further comprises a hub and a plurality of spokes converging on the hub,
and wherein the wire is attached to the hub, the spokes causing the
plunger and the wire to spiral as the plunger advances axially within the
housing.
7. A vascular access device for introducing a catheter into a blood vessel
comprising:
a housing having a proximal end and a distal end, a nose connected to the
distal end of the housing;
a hollow introducer needle having a tip and being attached to the nose;
a catheter concentrically fitted over the introducer needle and engaged
with the nose; and
a guide wire actuating mechanism comprising:
a resilient member;
a disk attached to the resilient member;
a guide wire attached to the disk and extending into the hollow introducer
needle; and
trigger means for selectively releasing said resilient member such that
such guide wire is advanced past the tip of said needle.
8. A vascular access device as defined in claim 7 said trigger means
comprising a shaft wherein the shaft engages the disk and selectively
prevents the resilient member from expanding and propelling the guide wire
past the beveled tip of the introducer needle and into the blood vessel.
9. A vascular access device as defined in claim 7 wherein the resilient
member is a spring.
10. A vascular access device for introducing a catheter into a blood vessel
comprising: a housing with a proximal end and a distal end, a nose
connected to the distal end of the housing, a hollow introducer needle
with a beveled tip attached to the nose, a catheter concentrically fitted
over the introducer needle and engaged with the nose, and a guide wire
actuating mechanism having
a plunger having a face disposed within the housing;
a resilient member disposed within the plunger;
a guide wire attached to the face of the plunger; and
a beam attached to the housing, the beam engaging the plunger face thus
preventing the resilient member from advancing the plunger distally within
the housing and propelling the guide wire past the beveled tip of the
introducer needle and into the blood vessel.
11. A vascular access device as defined in claim 10 wherein the beam
further comprises a pawl and the plunger face further comprises a rim, the
pawl engaging the rim and preventing the resilient member from advancing
the plunger distally within the housing.
12. A vascular access device as defined in claim 11 wherein the actuating
mechanism further comprises a release button attached to the beam,
downward force on the release button causing the beam to bend forcing the
release pawl to move away from the rim and allowing the plunger to
distally advance within the housing.
13. The vascular access device for introducing a catheter into a blood
vessel of claim 12 wherein the actuating mechanism comprises a track on
which the plunger advances distally within the housing.
14. The vascular access device for introducing a catheter into a blood
vessel of claim 12 wherein the housing further comprises a slit and a
elastomeric band, the release button positioned on the beam such that it
protrudes the housing through the slit and pushes against the elastomeric
band.
15. The vascular access device for introducing a catheter into a blood
vessel of claim 14 wherein the plunger face further comprises a tab to
which guide wire is attached and the beam further comprises an opening,
the tab of the plunger passing through the opening in the beam as the
plunger advances distally on the track.
16. The vascular access device for introducing a catheter into a blood
vessel of claim 15 wherein the plunger face further comprises a blood
bypass hole which allows flash back blood to pass through the plunger as
it advances distally on the track.
17. The vascular access device for introducing a catheter into a blood
vessel of claim 10 where the housing has a cap, the resilient member
attached to the cap thus permitting the actuating mechanism to be set or
reset in a locked position.
18. The vascular access device for introducing a catheter into a blood
vessel of claim 10 wherein the resilient member is a spring.
Description
1. THE FIELD OF THE INVENTION
The present invention is related to a device for facilitating the insertion
of vascular catheters. More particularly, the present invention relates to
an automatic mechanism for advancing a flexible wire into a blood vessel
thus facilitating the proper placement of an associated catheter.
2. BACKGROUND
During medical treatment, patients often require medication, blood, or
fluids. The most efficient way of administering these substances is by
depositing them directly into the patient's blood stream where the
circulatory system quickly directs the substance to the target tissue or
organ. Administering a substance directly into a patient's blood stream is
most commonly accomplished by injection with a conventional needle and
syringe. During the course of treatment, however, a patient will often
require repeated or continuous doses of medications. It will be
appreciated that repeated injections with a conventional needle can damage
veins or arteries and cause significant discomfort to the patient.
When a patient requires repeated doses of medication or other substances,
catheters are commonly employed. A catheter is a device that permits
repeated and continuous administration of medication directly into a
patient's blood stream, or other region of the body, without repeated
injections. In one common configuration, catheters have a hollow tubular
cannula and an adapter at the proximal end. The cannula of the catheter is
inserted into the vein or artery of a patient while the catheter adapter
remains outside the patient. The adapter permits repeated and continuous
access to the patient's vascular system thus obviating the need for repeat
injections.
In certain situations it is necessary to have access to the arteries of a
patient. Generally this is necessary in order to monitor blood pressure
and to take samples of arterial blood. In any event, in certain situations
it is desirable to have the ability to repeatedly access an artery without
making multiple needle punctures of the artery. In these situations it is
often desirable to inert an arterial catheter.
There are many known devices and methods for introducing a catheter into a
blood vessel. One such device uses an "inside-the-needle" configuration.
As its name implies, this device has a catheter coaxially located within a
hollow introducer needle. The patient's blood vessel is pierced with an
introducer needle. Once the needle is within the patient's blood vessel,
the catheter is manually advanced into the patient's blood vessel so that
the desired length of the catheter has been inserted. The needle is then
removed leaving the catheter in place. Thereafter, an adapter is attached
to the proximal end of the catheter so that medication or other substances
may be administered.
Another device used to introduce a catheter into a patient's blood vessel
also uses an introducer needle to penetrate the blood vessel but in an
"over-the-needle" configuration. In this arrangement, the catheter is
coaxially placed over the needle. Once the needle is within the patient's
blood vessel, the catheter is advanced over the introducer needle until
the desired length of the catheter has been inserted. The needle is
simultaneously withdrawn and discarded leaving the catheter in place.
Because the catheter is located over the needle, an adapter need not be
attached to the catheter after placement of the catheter in the blood
vessel, but can be attached to the catheter prior to placement.
It will be appreciated that for maximum comfort to the patient, catheters
should be constructed of a flexible pliable material. The more pliable the
material, however, the more difficult it is to insert the catheter into
the blood vessel. The catheter has a tendency to kink making its insertion
difficult, and in many cases impossible. This is especially true for
catheters that will be placed in an artery. As a result, vascular
catheters typically employ a thin wire called a guide wire which can be
advanced into the artery to provide a path for the catheter to follow
while the catheter is positioned within the blood vessel.
One such catheter uses an introducer needle to penetrate the patient's
artery. Once in place, a guide wire which is disposed within the
introducer needle is manually advanced into the artery. The catheter is
then detached and advanced from the introducer needle along the guide wire
which guides the catheter within the artery. The introducer needle and the
guide wire are then removed leaving the catheter in place.
Unfortunately, this device and method compromise stability by requiring the
clinician to hold the catheter unit with one hand while the guide wire is
manually advanced with the other. While the guide wire is being manually
advanced, the needle within the artery is subject to movement making it
difficult to steadily insert the guide wire.
Several automatic and semiautomatic devices and methods for advancing the
guide wire are known in the art. One such device requires the clinician to
carefully pierce the patient's skin with the introducer needle. Once the
skin is punctured, but before the introducer needle pierces the blood
vessel, a vacuum is created by manually extending a plunger or similar
apparatus. Subsequently, the introducer needle is advanced further until
the blood vessel is penetrated. Upon penetration, the vacuum in the
chamber is broken and the guide wire is advanced by one of several
different mechanisms. Alternatively, once the vacuum is broken and blood
is visible in the chamber, the operator can manually initiate the guide
wire advance mechanism.
Like the manual devices, these automatic and semiautomatic devices require
the clinician to steadily hold the catheter unit with one hand while the
plunger is extended to create a vacuum. In addition, these devices require
great skill on the part of the clinician. If the blood vessel is
penetrated before a vacuum is created, the guide wire will not
automatically advance. Moreover, if the guide wire fails to properly
advance neither the automatic nor the semiautomatic mechanisms permit the
guide wire advance mechanism to be reset and reinitiated.
It will be appreciated that it would be an advancement in the art to
provide a vascular access device that automatically advances a guide wire
into a blood vessel. It would be a further advancement in the art if the
guide wire could be advanced at a steady and a consistent rate and the
device reset if necessary. It would be yet another advancement in the art
if the flexible wire could be advanced with one hand without requiring the
operator to remove one hand from the device.
Such a vascular access device is disclosed and claimed herein.
3. BRIEF SUMMARY AND OBJECTS OF THE INVENTION
The present invention is directed to a vascular access device for
introducing a catheter into a blood vessel. The present invention uses an
introducer needle to penetrate the patient's skin and blood vessel. Once
in place, the operator can manually trigger an activating means located
within the device. A guide wire is then propelled past the tip of the
needle and into the blood vessel. A catheter concentrically located over
the introducer needle can then be advanced along the introducer needle and
guided into the blood vessel by the guide wire. Once secure in the blood
vessel, the introducer needle and the guide wire are removed leaving the
catheter in place in the patient.
In one preferred embodiment, the vascular access device comprises a
housing, an introducer needle, a guide wire, and an actuating mechanism,
together with an associated catheter. The housing is generally cylindrical
and accommodates the actuating mechanism disposed within its hollow
center. The proximal end of the housing is sealed by a cap. The cap may be
attached to the housing by a variety of means including threads or
resilient means. The distal end of the housing defines a nose which may be
constructed as a single piece integral with the housing, or alternatively
may be constructed separately and attached. The proximal end of the
introducer needle is secured within the nose with the distal end of the
introducer needle having a beveled tip for penetrating a blood vessel.
The typical catheter used in connection with the device is comprised of a
hollow cannula that fits concentrically over the introducer needle. The
proximal end of the cannula is connected to an adapter that fits over the
nose of the housing and is attached by friction engagement. It will be
appreciated that the specific shape of the catheter adapter and housing
nose are not critical to the invention. The catheter adapter, for example,
may be compatible with an IV administration set that provides the fluid to
be administered to the patient.
The guide wire is disposed within the hollow introducer needle and extends
through the nose and into the cavity of the housing. As will be explained
in greater detail below, the proximal end of the guide wire is in
communication with the actuating mechanism at the rear of the housing. The
guide wire is longer than the introducer needle. However, when the
vascular access device is in a locked position (i.e., before the
advancement of the guide wire) the distal tip of the guide wire preferably
does not extend beyond the beveled tip of the introducer needle. In the
presently preferred embodiments of the device, the guide wire is flexible
but also sufficiently rigid to prevent kinking as it is inserted into the
blood vessel. It will be appreciated by one skilled in the art that the
exact flexibility and rigidity will depend on the particular use and
location where the catheter is to be inserted.
The actuating mechanism is generally disposed within the rear of the
housing and generally comprises a resilient member, a disk, and a trigger.
The proximal end of the resilient member is attached to the housing cap
and the distal end of the resilient member is attached to the disk. Also
attached to the disk is the proximal end of the guide wire. When the
vascular access device is in a first locked position, the resilient member
and disk are compressed toward the rear of the housing. The trigger
engages the disk preventing the resilient member from expanding and the
guide wire from advancing.
In use, a clinician first pierces the skin and penetrates the patient's
blood vessel with the introducer needle. Once the introducer needle is in
the lumen of the blood vessel, the trigger of the actuating mechanism is
manually depressed. Depressing the trigger causes the end of the trigger
to disengage from the disk permitting the resilient member and disk to
expand axially through the interior of the housing. The expansion of the
resilient member and disk propels the distal end of the guide wire beyond
the beveled tip of the introducer needle and into the blood vessel.
Thereafter, the catheter adapter is removed from the housing nose and the
catheter is slid along the introducer needle and guide wire. The guide
wire guides the catheter until the catheter is secured within the blood
vessel. Once the catheter is in place, the introducer needle and guide
wire are removed. The catheter cannula remains within the lumen of the
patient's blood vessel while the catheter adapter remains outside the
patient, facilitating the introduction of medication, fluids, blood and
other substances.
These and other objects and advantages of the present invention will become
more fully apparent by examination of the following description of the
preferred embodiments and the accompanying drawings.
4. BRIEF DESCRIPTION OF THE DRAWINGS
A more particular description of the invention briefly described above will
be rendered by reference to the appended drawings. Understanding that
these drawings only provide information concerning typical embodiments of
the invention and are not therefore to be considered limiting of its
scope, the invention will be described and explained with additional
specificity and detail through the use of the accompanying drawings, in
which:
FIG. 1 is a cross sectional view of the vascular access device of the
present invention in the locked position before the advancement of the
guide wire.
FIG. 2 is a partially cut-away perspective view of the locking mechanism
before the advancement of the guide wire.
FIG. 3 is a cross sectional view of the vascular access device of the
present invention in the unlocked position with the spring expanded and
the guide wire fully advanced.
FIG. 4 is a partially cut-away perspective view of the locking mechanism
following advancement of the guide wire.
FIG. 5 is a cross sectional view of an alternative embodiment of the
vascular access device of the present invention in the locked position
before the advancement of the guide wire.
FIG. 6 is a cross sectional view taken along line 6--6 illustrated in FIG.
5.
FIG. 7 is a cross sectional view of an alternative embodiment of the
vascular access device of the present invention in the locked position
before the advancement of the guide wire.
FIG. 8 is a cross sectional view of an alternative embodiment of the
vascular access device of the present invention in the locked position
before the advancement of the guide wire.
FIG. 9 is a cross sectional view taken along line 9--9 illustrated in FIG.
8.
5. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention is a vascular access device for inserting a catheter
into a blood vessel. Generally, the vascular access device comprises a
hollow introducer needle, a catheter concentrically placed over the
introducer needle, an actuating means, and a guide wire running from the
actuating means to the introducer needle. A catheter is positioned over
the needle prior to operation of the device. In practice, the introducer
needle is inserted into a blood vessel. Once in place, the actuating means
is manually initiated and the guide wire is advanced beyond the end of the
introducer needle and into the blood vessel. Thereafter, the catheter is
uncoupled from the introducer needle and slid along the introducer needle
and guide wire until the catheter is secured within the blood vessel.
Finally, the introducer needle and guide wire are removed leaving the
catheter in the blood vessel. Accordingly, the vascular access device of
the present invention permits the operator to easily and steadily advance
the guide wire into the patient's blood vessel using only one hand.
Reference is now made to the figures wherein like parts are designated by
like numerals throughout. One embodiment of the vascular access device of
the present invention is designated 10 in FIG. 1. The vascular access
device 10 generally comprises a generally cylindrical housing 26, an
introducer needle 12, a catheter 16, an actuating mechanism 40, and a
guide wire 22. The basic components of the device housed within housing 26
include spring 56 which is held in place by disk 50, the operation of
which will be discussed in additional detail below. Also contained within
housing 26 is the actuating mechanism 40 which allows for selective
release of spring 56. Running from disk 50 through the interior of housing
26 and out into the interior of needle 12 is guide wire 22. The primary
purpose of device 10 is to aid in the placement of guide wire 22 within a
blood vessel, and the subsequent placement of catheter 16.
As illustrated in FIG. 1, housing 26 is generally cylindrical and has a
cylindrical cavity 36. The rear end of housing 26 has a cap 34 that seals
cavity 36. Cap 34 may be attached by a variety of means including molding
in place, friction engagement, or threaded attachment. Housing 26 is
preferably constructed of a rigid plastic. One skilled in the art will
appreciate, however, that housing 26 may be constructed of other rigid
materials. Similarly, the shape of housing 26 may be varied to meet
specific needs. Any shape that allows the operator firmly and comfortably
to grip the vascular access device 10 is within the scope of the
invention.
Housing 26 also has a slit 58 that, as will be explained in more detail
below, accommodates trigger 42 of actuating mechanism 40. Slit 58 is
covered by a plastic or rubber jacket 30 which wraps around the outer
circumference of housing 26. Jacket 30 also facilitates the gripping of
vascular access device 10 by the operator.
The distal portion of housing 26 includes a nose portion 28. In a preferred
embodiment, nose 28 and housing 26 are molded from a single piece of
material. However, nose 28 and housing 26 may be constructed as separate
segments and attached by a variety of means, including adhesive or
threaded engagement. Moreover, nose 28 and housing 26 may be constructed
of the same or different materials.
Attached to nose 28 is introducer needle 12. As illustrated in FIG. 1,
introducer needle 12 is hollow or cannulated throughout its entire length
and has a beveled tip 18 at its distal end used to penetrate the skin and
blood vessel. In FIG. 1, the proximal end of introducer needle 12 runs
through the center of nose 28 and spans its entire length from cavity 36.
It is not critical, however, that introducer needle 12 span the entire
length of nose 28. The proximal end of introducer needle 12 may, for
example, be attached only to the distal end 29 of nose 28. In that case, a
hole must be bored through the proximal end 27 of nose 28 providing an
opening from cavity 36 of housing 26 to introducer needle 12 so that the
guide wire 22 can travel through the nose 28.
FIG. 1 also illustrates catheter 16 attached to nose 28 by means of
friction engagement between nose 28 and catheter adapter 38. Catheter 16
has a tip 14, a cylindrical hollow cannula 62, and an adapter 38. Catheter
16 fits concentrically over introducer needle 12 and nose 28. Adapter 38
is configured such that it couples with nose 28 by friction engagement.
However, other engagement methods, including threads and Luer lock
mechanisms, may be employed to secure catheter 16 to nose 28. The overall
length of catheter 16 is such that when catheter 16 is fastened to nose
28, beveled tip 18 of introducer needle 12 extends beyond tip 14 of
catheter 16.
With continued reference to FIG. 1, vascular access device 10 has an
actuating mechanism 40. Actuating mechanism 40 is disposed within cavity
36 toward the proximal end of housing 26. Actuating mechanism 40 generally
comprises a trigger 42, a disk 50, and a spring 56. In the illustrated
embodiment, spring 56 is a coil spring with a diameter less than the
diameter of cavity 36. At the proximal end of housing 26, spring 56 is
attached to cap 34. At the opposite end of cap 34, spring 56 is attached
to disk 50. Spring 56 may be attached to or rest against cap 34 and disk
50. The diameter of disk 50 is preferably greater than the diameter of
spring 56, but less than the diameter of cavity 36 such that disk 50 can
move freely through the interior of cavity 36. As best illustrated in FIG.
2, disk 50 has a U-shaped aperture 54 that carves out a disk tab 52. As
will explained below, disk tab 52 serves to hold spring 56 in abeyance
when the actuating mechanism is in a locked position prior to the
advancement of guide wire 22 into the patient's blood vessel.
Attached to disk 50 is a guide wire 22. As shown in FIG. 1, the proximal
end of guide wire 22 penetrates disk 50 and is affixed by friction
engagement, adhesive, or other engagement mechanism. From disk 50, guide
wire 22 extends forwardly through cavity 36, nose 28, and introducer
needle 12. Before initiating the actuating mechanism, the distal tip of
guide wire 22 is disposed within introducer needle 12 but does not extend
beyond beveled tip 18.
Trigger 42 engages disk 50 and spring 56. In the illustrated embodiment,
trigger 42 is a sickle-shaped element with a trigger shaft 60 at its
proximal end and a trigger arm 44 at its distal end. Near the center of
trigger 42, between trigger shaft 60 and trigger arm 44, is a bell-shaped
boss 43 with a bore 45 running perpendicular to trigger 42. Trigger 42 may
be constructed of any material known in the art, such as plastic or metal,
and may be flexible as illustrated in FIG. 3, or rigid.
As illustrated in FIG. 1, trigger 42 is pivotally attached to housing 26 by
a trigger pin 46. Trigger pin 46 traverses the width of cavity 36, passes
though bore 45 of boss 43 and is affixed at either end to housing 26. As
such, trigger pin 46 secures trigger 42 to housing 26. The diameter of
bore 45, however, is larger that the diameter of pin 46. Trigger pin 42,
therefore, can freely pivot about trigger pin 46.
As depicted in FIG. 1 and FIG. 2, trigger shaft 60 extends proximally from
trigger pin 46. The proximal end of trigger shaft 60 has a notch 64 that
forms a seat 68. In the locked position, spring 56 is compressed toward
the rear of cavity 36 and notch 64 extends through aperture 54 of disk 50.
Spring 56 is kept from expanding and advancing axially along cavity 36 by
disk tab 52 which overlaps and is biased against seat 68 of trigger 42.
The relative position of disk tab 52 and seat 68 is maintained by a trigger
spring 48 near the distal end of trigger 42. Trigger spring 48 is in
communication with trigger 42 and provides resistance against trigger arm
44. The resistance may be provided by means of a spring or any other
resilience means well known in the art. The action of trigger spring 48
forces trigger arm 44 to extend through slit 58 of housing 26 and against
plastic cover 30. The force of trigger arm 44 causes cover 30 to expand,
allowing trigger arm 44 to protrude through slit 58 of housing 26.
Simultaneously, the action of trigger spring 48 causes trigger 42 to pivot
about trigger pin 46 and boss 43, urging seat 68 to overlap disk tab 52.
Additionally, the resistance of spring 56 against disk 50 causes
significant friction between disk tab 52 and seat 68 further ensuring that
the two remain in an overlapped position.
While disk tab 52 and seat 68 of trigger 60 are overlapped, spring 56
cannot advance axially along cavity 36 and guide wire 22 remains within
introducer needle 12. To advance guide wire 22 beyond beveled tip 18, the
clinician depresses the portion of trigger arm 44 that protrudes through
slit 58 of housing 26. This causes trigger 42 to pivot about trigger pin
48 and forces trigger shaft 60 away from disk tab 52 of disk 50. As
trigger shaft 60 moves away from disk tab 52, seat 68 of trigger shaft 60
slides off disk tab 52.
As best illustrated in FIG. 3 and 4, when seat 68 no longer overlaps disk
tab 52, spring 56 can expand and advance disk 50 through cavity 36. As
spring 56 expands, trigger shaft 60 passes through aperture 54 of disk 50.
As a result of the expansion of spring 56 and the advancement of disk 50,
guide wire 22 is propelled past the beveled tip 18 of introducer needle
12. Disk 50 and guide wire 22 come to rest when spring 56 is fully
extended or disk 50 is delimited by boss 43. It will be appreciated by one
skilled in the art that the speed and force at which guide wire 22 is
advanced is directly proportional to the force exerted by spring 56. Thus,
depending on the precise location where catheter 16 is being inserted, the
force at which guide wire 22 is extended may be tailored by choosing the
size and resilient force of spring 56.
In practice, while in the locked position, introducer needle 12 is used to
pierce the skin and penetrate the blood vessel. Once in the blood vessel,
actuating mechanism 40 is initiated by depressing trigger arm 44 through
plastic cover 30. The force against the trigger arm 44 causes trigger 42
to pivot about trigger pin 46 disengaging seat 68 from disk tab 52. This
permits spring 56 to expand thus propelling disk 50 axially along cavity
36 toward introducer needle 12. As a result, guide wire 22 which is
attached to disk 50 advances beyond beveled tip 18 of introducer needle 12
and into the blood vessel. Guide wire 22 also substantially prevents back
bleeding through introducer needle 12. Should guide wire 22 fail to fully
advance for any reason, the clinician can reset actuating mechanism 40 by
disengaging cap 34 from housing 26 and pulling cap 34 proximally until
disk 50 reengages seat 68 of trigger 42. Cap 34 can then be reattached to
housing 26 and actuating mechanism 40 can be reinitiated.
While holding housing 26, the operator uncouples catheter 16 from nose 28
and slides it along introducer needle 12 and guide wire 22 until the
desired length of cannula 62 of catheter 16 is within the blood vessel.
Once in place, the operator holds catheter 16 in place while slowly
retracting housing 26, introducer needle 12, and guide wire 22. Catheter
16 can then be used to administer, medication, or other fluids.
FIG. 5 illustrates an alternative embodiment of the present invention
employing an alternative activating means. In FIG. 5, vascular access
device 110 has an actuating mechanism 70 generally comprising a plunger
72, a spring 78 and a lever 84. When actuating mechanism 70 is in a locked
position before the advancement of guide wire 122 into the blood vessel,
plunger 72 is disposed toward the proximal end of cavity 136 of housing
126. Plunger 72 is cylindrical with a diameter smaller than the diameter
of housing 126 thus permitting it to move axially within cavity 136.
As best illustrated in FIG. 6, the distal face of plunger 72 has a
plurality of spokes 74 and a hub 76. Spokes 74 are evenly spaced and
converge on hub 76 in the center of the plunger face. Plunger 72, spokes
74 and hub 76 may be molded from a single material or molded separately
and assembled, for example, using adhesive, threaded or friction
engagement. Guide wire 122 is attached to the center of hub 76 by
adhesive, threaded or friction engagement and extends distally from hub 76
through cavity 136 and into introducer needle 112. Spokes 74 may be
configured such that as plunger 72 advances distally through cavity 136,
spokes 74 cause plunger 72 and guide wire 122 to spiral. The spiral motion
of guide wire 122 assisting its entry into the blood vessel.
Disposed with plunger 72 is coiled spiral spring 78. As will be explained
further below, in its fully extended state, spring 78 is longer than
plunger 72 so that it is capable of propelling plunger 72 distally when
actuating mechanism 70 is initiated. The proximal face of plunger 76 is
open allowing spring 78 to contact cap 134 of housing 126. When the
vascular access device is in a locked position, spring 78 is compressed
toward the rear of housing 126 delimited proximally by cap 134 and
distally by spokes 74 of plunger 72. Moreover, it will be appreciated by
one skilled in the art that the maximum compressed state of spring 78 is
dictated by the length of plunger 72. Thus, depending on the precise
location where catheter 116 is to be inserted, the length and force with
which guide wire 122 is extended into the blood vessel may be tailored by
choosing, not only the size and resilience of spring 78, but also the
length of plunger 72. For example, the combination of a short plunger and
a highly resilient spring will cause guide wire 122 to be advanced a
greater distance and with greater force into the blood vessel.
With continued reference to FIGS. 5 and 6, housing 126 has a recess 80 and
a channel 82. Together, recess 80 and channel 82 create an opening through
housing 126 into cavity 136. As illustrated in FIG. 5, channel 82 extends
the entire length of recess 80. It will be appreciated by one skilled in
the art, however, that channel 82 need only be large enough to accommodate
pawl 90. When actuating mechanism 70 is in a locked position, recess 80
and channel 82 extend from the distal end of housing 126 near nose 128
proximally beyond the distal face of plunger 72. Lever 84 rests on top and
extends the entire length of housing 126. Toward the proximal end of
housing 126, from the proximal end of recess 80 to cap 134, lever 84 is
attached to housing 126 by adhesive engagement or other means well known
in the art. At the distal end of housing 126, lever 84 rests within, but
is not attached to, recess 80.
Lever 84 is made of a resilient material such as plastic or metal and has a
notch 85 and a tab 88. Notch 85 is adjacent to where lever 84 is attached
to housing 126. As will explained below, notch 85 facilitates the bending
of lever 84 during actuation of the vascular access device 110. Tab 88 is
at the distal end of lever 84. The width of tab 88 is less than recess 80
but greater than channel 82, thus preventing the distal end of lever 84
from passing through channel 82 into cavity 136 of housing 126. The height
of tab 88 is such that when tab 88 is resting over channel 82, lever 84 is
flush with housing 126 and level with the proximal end of lever 84.
Lever 84 also has a wire release button 86 at its distal end and a release
pawl 90 near the proximal end of recess 80. Wire release button 86 extends
above recess 80 of housing 126 for easy access and gripping by the
clinician. Release pawl 90 of lever 84 projects below recess 80 and
channel 82 and into cavity 136 of housing 126. When actuating mechanism 70
is in a locked position, release pawl 90 overlaps the distal face of
plunger 72. The resilient force of spring 78 drives plunger 72 against
release pawl 90 which urges wire release button 86 against abutment 92
thus preventing spring 78 from expanding and plunger 72 from advancing
distally along cavity 136.
In practice, while in the locked position, introducer needle 112 is
inserted into the blood vessel. Once in the blood vessel, the clinician
initiates actuating mechanism 70 by gripping wire release button 86 and
applying force proximally against the resilient force of spring 78 and
away from abutment 92. When wire release button 86 is no longer in contact
with abutment 92, and with continued pressure against spring 78, the
clinician pulls the wire release button 86 up and away from housing 26.
The upward force causes the distal end of lever 84 to bend about notch 85.
As lever 84 bends upward away from housing 126, release pawl 90 moves out
of cavity 136 and away from plunger 72. When release pawl 90 and plunger
72 no longer overlap, the resilient force of spring 78 against cap 134
advances plunger 72 distally along cavity 136, propelling guide wire 122
past beveled tip 118 of introducer needle 112 and into the patient's blood
vessel. As plunger 72 advances, spokes 74 cause plunger 72 and guide wire
122 to spiral facilitating the entry of guide wire 122 into the blood
vessel. The openings between spokes 74 in the distal face of plunger 72
allow blood to pass through plunger 72 as it advances preventing the blood
from being reintroduced into the patient's blood vessel. Plunger 72 comes
to rest when the distal face of plunger 72 contacts the distal end of
housing 126. Once guide wire 122 is in position within the patient's blood
vessel, catheter 116 is inserted and guide wire 122 and introducer needle
112 are removed as explained above.
FIG. 7 illustrates an alternative guide wire advancement mechanism for
vascular access device 210 of the present invention. In FIG. 7, vascular
access device 210 has an actuating mechanism 200 generally comprising a
plunger 202, a spring 204, a lever 208 and optionally a handle 206.
Plunger 202, spring 204 and guide wire 222 are configured as in FIG. 6
except that a handle 206 is attached to the distal face of plunger 202.
Handle 206 can be attached to the distal face of plunger 202 by a variety
of means, included adhesive, threaded, or friction engagement. From the
distal face of plunger 202, handle 206 extends through the center of
spring 204 and opening 207 in cap 234. Guide wire 222 is attached to the
distal face of plunger 202 and extends distally through cavity 236 and
introducer needle 212.
The top of housing 226 has a recess 210. When actuating mechanism 200 is in
a locked position prior to the advancement of guide wire 222, recess 210
extends from the distal end of housing 226 near nose 228 proximately to
the distal face of plunger 202. Inset in recess 210 is lever 208
comprising a wire release button 214, release pawl 216, return spring 218
and fulcrum 220. Lever 208 is attached to housing 226 by fulcrum 220. The
exact means by which fulcrum 220 attaches lever 208 to housing 226 is not
critical to the invention. Threaded, adhesive or friction engagement, or
any combination thereof, may be employed provided the engagement permits
lever 208 to pivot about fulcrum 220.
With continued reference to FIG. 7, lever 208 is flush with housing 226
except for wire release button 214 which, for reasons that will be
explained in further detail below, extends above recess 210. Release pawl
216 projects below recess 210 into cavity 236 through release pawl hole
212 in housing 226. When actuating mechanism 200 is in a locked position,
release pawl 216 overlaps plunger 202 preventing it from advancing
distally through cavity 236. The resilient force of return spring 218
against housing 226 causes lever 208 to pivot about fulcrum 220 ensuring
that release pawl 216 remains engaged with plunger 202.
In practice, if vascular access device 210 is not in a locked position, the
clinician first pulls handle 206 proximately until the distal face of
plunger 202 is beyond release pawl hole 212 and engages release pawl 216.
Once in a locked position, introducer needle 212 is inserted into the
blood vessel. The clinician then initiates actuating mechanism 200 by
depressing the portion of wire release button 214 which extends above
recess 210 of housing 226. The downward force on wire release button 214
against return spring 218 causes lever 208 to pivot about fulcrum 220
driving release pawl 216 out of cavity 236 through release pawl hole 212
and away from the distal face of plunger 202. When release pawl 216 is
completely out of cavity 236 and no longer overlapping the distal face of
plunger 202, the resilient force of spring 204 against cap 234 advances
plunger 202 distally along cavity 236. As plunger 202 advances guide wire
222 is propelled past beveled tip 218 of introducer needle 212 and into
the patient's blood vessel. Once guide wire 222 is in position within the
patient's blood vessel, catheter 216 is inserted and guide wire 222 and
introducer needle 212 are removed as explained above.
FIGS. 8 and 9 illustrate yet another embodiment of the present invention
which employs an alternative means of advancing guide wire 322 into a
patient's blood vessel. In FIG. 8, vascular access device 310 has an
actuating mechanism 330 generally comprising a plunger 332, a spring 334,
a wire release mechanism 336 and a plunger track 338. Track 338 is a thin
cylindrical tube attached to the inner wall of housing 326 by adhesive
engagement, or other engagement well known in the art. One skilled in the
art will appreciate, however, that track 338 and housing 326 can be molded
from a single material. Track 338 extends from the proximal end of housing
326 near cap 334 distally up to or near release button 342 of wire release
mechanism 336. It will be appreciated by one skilled in the art that the
exact length of track 338 and housing 326 may be varied depending on the
distance that guide wire 322 is to be inserted into the patient's blood
vessel.
Plunger 332 is disposed within and capable of moving axially along track
338. The relative configuration of plunger 302 and spring 334 is as in
FIG. 6 except that the distal face of plunger 332 has a rim 340, a tab
342, and a blood bypass hole 335. Spring 334, disposed within plunger 332,
is delimited proximately by cap 334 and distally by rim 340 of plunger
332.
As best illustrated in FIG. 9, blood bypass-hole 335 forms tab 342 and
prevents flashback blood from being reintroduced into the artery by
plunger 372 as it advances distally through cavity 336. In addition, as
will explained below, blood bypass hole 335 accommodates beam 344 as
plunger 332 advances distally along track 338. Guide wire 322 is attached
by adhesive, threaded or friction engagement to tab 342. From tab 342,
guide wire 322 extends distally through cavity 336, socket 348 and
introducer needle 312.
When actuating mechanism 330 is in a locked position, plunger 332 and
spring 334 are held in abeyance by guide wire release mechanism 336
disposed with cavity 336 of housing 326. Guide wire release mechanism 336
comprises a release button 342, a beam 344 and a release pawl 346. Beam
344 is attached to the distal end of housing 326 near nose 328 by threaded
friction or adhesive engagement with socket 348 which is attached to and
centered over the proximal end of nose 328. For reasons explained below,
beam 344 has an opening 345 and is made of plastic, metal or other
resilient material. From socket 348, beam 344 extends proximally to the
distal face of plunger 332. Prior to initiation, release pawl 346 at the
proximal end of beam 344 overlaps rim 340 on the distal face of plunger
332 preventing plunger 332 from advancing distally on track 338. At the
distal end of beam 344, and in the same orientation as release pawl 346,
is attached a release button 342. Release button 342 is positioned such
that it protrudes from housing 326 through slit 350 and pushes against
elastomeric band 352. The resilient force of beam 344 ensures that release
button 342 remains biased against elastomeric band 352.
In practice, introducer needle 312 is first inserted into the blood vessel.
Once in the blood vessel, the clinician initiates actuating mechanism 330
by depressing release button 342 through elastomeric band 352. The
downward force on release button 342 causes beam 344 to bend, forcing
release pawl 346 downward and away from rim 340 of plunger 332. When
release pawl 346 no longer overlaps rim 340, the resilient force of spring
334 against cap 334 advances plunger 332 and guide wire 322 distally on
track 338. As plunger 332 advances distally, beam 344 and release pawl 346
pass through blood bypass hole 335 on the distal face of plunger 332 and
the center of spring 334. Tab 342 advances down the center of beam 344
through opening 345. Should guide wire 322 fail to fully advance for any
reason, the clinician can reset actuating mechanism 330 by disengaging cap
334 from housing 326 and pulling cap 334 proximally until pawl 346 engages
rim 340 on the face of plunger 332.
Blood bypass hole 335 in the distal face of plunger 332 allows flash back
blood to pass through plunger 332 as it advances distally on track 338.
Thus, the flash back blood is not reintroduced back into the patient's
blood vessel. Plunger 332 comes to rest and guide wire 322 ceases to
advance when rim 340 reaches abutment 354 of track 338. Once guide wire
322 has ceased to advance and is in position within the patient's blood
vessel, catheter 316 is inserted and guide wire 322 and introducer needle
312 is removed as explained above.
Thus, the present invention overcomes some significant limitations of the
existing art. The present invention provides a vascular access device
which automatically advances a guide wire into a blood vessel to
facilitate that placement of a vascular catheter. The guide wire is
advanced at a steady and consistent rate, and can be reset if necessary.
The present invention allows for the insertion of the guide wire by use of
one hand. This allows the operator to carefully and accurately place the
catheter in the subject blood vessel. Thus, the present invention
represents an advancement in the art of catheter placement.
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