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Description  |
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This invention relates to a vascular access implant needle patch.
In the past, it has been known to implant a vascular access device within
the body of a patient in order to provide a convenient technique for
administering drugs and fluids over a prolonged period of time. Generally,
these devices include a self-sealing silicone septum encased in a port
made of metal or plastic and attached to a silicone catheter. Usually, the
catheter is placed in a vein for the delivery of a drug or fluid.
In order to enter the port of the vascular access device, use has been made
of various types of devices, for example a Huber needle. Usually, the
Huber needle is bent and deflected in order to prevent coring of the
septum. In this resoect, regular hypodermic needles have not been used on
the basis that such would damage the septum. In addition, a luer lock
extension set has usually been provided with the Huber needle.
However, the techniques used for inserting a Huber needle have been rather
cumbersome. For example, once the Huber needle has been inserted through
the septum of a vascular access device, it has been necessary to use one
piece of tape to support the needle and a second piece of tape to secure
the luer lock extension. In addition, it has been necessary to apply an
antiseptic, such as a povidone-iodine ointment, at the needle-to-skin
junction. Still further, it has been necessarv to apply a dressing from a
separate dressing kit to cover the injection site and to use a tape
dressing to secure the gauze dressing.
Since the dressings have usually been made of opaque materials, it has been
necessary to remove the dressings from time to time, for example every 24
or 48 hours, in order to inspect the injection site for possible sepsis.
Additional problems which are associated with the above procedure include
the possibility of significant movement and "pistoning" of the Huber
needle since the needle is not securely fixed in place at the injection
site. Further, excessive antispetic ointment may be applied to the
injection site with a result that there is a risk of a skin burn
occurring. Still further, the insertion procedure requires the
practitioner to use gloves since the practitioner's finger must push right
up against the shank of the Huber needle.
Infusion needle attachments are also known, for example as described in
U.S. Pat. No. 4,380,234, wherein an elastomeric member is attached to an
infusion needle in order to conveniently handle and guide the needle into
place. In particular, it has been known to provide a disc-like body with a
tubular member at the periphery of the of the body and at a selected
angular orientation in order to position a needle so that the presence of
the needle can be masked by the disc-like body when implanted. However,
such infusion needle attachments are generally not suitable for use with
an implanted vascular access device.
Accordingly, it is an object of the invention to provide a simple needle
patch which can be readily used with an implanted vascular access device.
It is another object of the invention to provide a needle patch which
permits ready inspection of an injection site.
It is another object of the invention to deliver a controlled amount of
antiseptic to an injection site.
It is another object of the invention to provide a needle patch which can
be readily inserted into an implanted vascular access device.
It is another object of the invention to provide a needle patch which can
be securely held in place on a patient after being inserted into an
implanted vascular access device.
Briefly, the invention provides a needle patch which is comprised of a
flexible patch for mounting on a patient, a rigid housing which is secured
to the patch to define a finger grip and a hollow needle having an angled
portion extending perpendicularly from the patch.
The flexible patch is made of transparent material and may include a pair
of discs which are integrally secured together. In order to secure the
patch in place, an adhesive layer may be formed on a lower surface of the
oatch and may be covered over by a removable sheet which can be removed
for application of the needle patch to a patient.
The needle is positioned between the discs of the patch so that the angled
portion passes through a central aperture in one disc while a main portion
of the needle is disposed between the two discs and extends into the rigid
housing. In addition, a flexible tube is connected to the main portion of
the needle within the rigid housing and may carry a luer connection at the
opposite end.
The upper disc of the patch is also provided with a means to define a
reservoir above the aperture in the lower disc for receiving an
antiseptic, such as an antiseptic ointment. In addition, an annular wall
may extend from the upper disc through the aperture in the lower disc in
order to define a dam for retaining the antiseptic ointment.
In order to use the needle patch, the finger grip provided by the rigid
housing is first grasped with the middle finger and thumb. Next, with the
fore finger positioned over the needle, that is on the upper surface of
the transparent patch, the releasable sheet is removed to expose the
adhesive layer and the needle inserted into a septum of a vascular access
device implant within a patient. With this technique, there is no need to
touch the injection site or the needle. As such, a sterile insertion
technique can be obtained without need for the practitioner to be gloved.
If an antispetic ointment has been placed in the reservoir prior to needle
placement, the ointment may be expelled from the reservoir after insertion
of the needle so as to deposit a small quantity of the ointment at the
injection site. At this time, the dam prevents a migration of the ointment
which might otherwise cause a lift-off between the adhesive layer and the
skin of the patient.
Once the needle has been inserted, it is possible to inspect the injection
site for contamination by viewing directly through the transparent discs.
Thus, there is no need to remove the patch in order to evaluate the site.
Of note, the adhesive layer on the patch serves to securely fix the needle
patch in place. The strength of this adhesive should be such that the
lateral tugging of the tube attached to the patch causes the tube to "neck
down" before the patch would separate from the skin of the patient.
Further, the tube permits various types of drugs and fluids to be
administered to a patient from a remote hook-up position away from the
injection site.
In another embodiment, the Huber needle may be formed with a main portion
which extends at an angle to the lower disc of the needle patch. In this
case, the upper disc would be provided with a cavity to receive the needle
When such a needle is inserted into a vascular access device, a slight
rotation of the needle occurs. In the case of a Huber needle, this
facilitates entry of the tip of the needle through a septum. Further,
since the upper disc is flexible, rotation of the needle can be readily
accomplished.
These and other objects and advantages of the invention will become more
apparent from the following detailed description taken in conjunction with
the accompanying drawings wherein:
FIG. 1 illustrates a needle patch according to the invention mounted in
place;
FIG. 2 illustrates the needle patch of FIG. 1 immediately prior to
insertion into an implanted vascular access device;
FIG. 3 illustrates a partial cross sectional view of the needle patch of
FIG. 1;
FIG. 4 illustrates an exploded view of the needle patch of FIG. 1;
FIG. 5 illustrates a bottom view of the needle patch of FIG. 1;
FIG. 6 illustrates a top view of the needle patch of FIG. 1;
FIG. 7 illustrates an exploded view of a modified needle patch according to
the invention;
FIG. 8 illustrates a bottom view of the needle patch of FIG. 7;
FIG. 9 illustrates a top view of the needle patch of FIG. 7; and
FIG. 10 illustrates an enlarged view of the needle of the needle patch of
FIG. 7.
Referring to FIG. 1, the needle patch 10 is constructed for use with a
vascular access device 11 which is implanted under the skin 12 of a
patent. In this respect, the vascular access device is of known
construction and includes a catheter 13 for connection with a vein or
artery of the patient.
Referring to FIGS. 2 and 4, the needle patch 10 includes a pair of flexible
transparent discs 14, 15 which are integrally secured together so as to
form a flexible patch for mounting on the patient. In addition, a rigid
housing 16 is integrally molded to the upper disc 15 and is shaped to
define a finger grip. Still further, a hollow needle 17, such as a Huber
needle, is sandwiched between the discs 14, 15 and is connected to a
flexible tube 18 which extends from the housing 16.
Referring to FIG. 4, the lower disc 14 is in the form of a carrier film
which is provided on the topside with a layer of adhesive 19 in order to
secure the carrier film to the upper disc 15. In addition, the carrier
film is provided on the underside with a layer of adhesive 20 as well as
with a removable sheet 21 which is disposed over the adhesive layer 20 in
order to protect the adhesive. In addition, as indicated in FIG. 5, the
lower disc 14 has a central aperture 22 for passage of the needle 17.
The upper disc 15 is of the same diametric size as the lower disc 14 and
may be provided with a tapered rim 23 (see FIG. 6) to impart flexibility
at the edge of the path 10 for securement to the skin 12. In addition, the
upper disc 15 is provided with a means such as a dome-shaped projection 24
for defining a reservoir about the aperture 22 in the lower disc 14 in
order to receive an antiseptic, such as an antiseptic ointment 25 (see
FIG. 3). Still further, the upper disc 15 is provided with an annular wall
26 which extends from the disc 15 through the aperture 22 in the lower
disc 14 in order to define a dam for retaining the ointment 25 which is
expelled from the reservoir defined by the projection 24. This wall 26 is
provided with a small slit (not shown) to accommodate passage of the
passage of the needle 17 without leakage of ointment.
The needle 17 is secured to the flexible tube 18 via a suitable cement so
as to form a fixed connection. In addition, the needle 17 has a main
portion 27 which extends in parallel between the discs 14, 15 and a
downwardly angled portion 28 which extends perpendicularly through the
aperture 22 in the lower disc 14. As indicated in FIG. 4, the free end 29
of the needle 17 is slightly angled relative to the angled portion 28 as
is known. By being connected to the housing 16, the hollow needle 17
rigidifies the housing 16 and provides a finger grip carrier to hold the
needle 17 during septum puncture.
The housing 16 is integrally molded with the upper disc 15 to form a one
piece construction. As indicated in FIG. 6, the side walls 30 of the
housing 16 are slightly indented so as to provide a finger grip, for
example for the thumb and middle finger. The transparency of the housing
also permits a clear view of the needle 17 and tube 18. In this respect,
the main portion 27 of the needle 17 extends substantially through the
housing 17 while the tube is inserted a short distance into the housing.
The housing 16 is also provided with a shaped surface 31 located over the
main portion of the needle 17 to provide a further finger grip, for
example for the index finger.
Referring to FIG. 2, the tube 18 may have a luer connection 32 at the free
end as well as a clamp 33 at an intermediate point.
In order to use the needle patch 10, the usual procedures would be followed
in order to connect the luer connection 32 to an administration set and to
clear the tube 18 and needle 17 of air. Thereafter, the needle patch 10 is
grasped, for example by gripping the surfaces 30 between the thumb and
middle finger. Next, the removable sheet 21 is stripped from the lower
disc 14 and the needle 17 inserted through the skin 12 of the patient into
and through a septum (see FIG. 1) in the implanted vascular access device
11. At this time, pressure can be applied by an index finger on the shaped
surface 31 as well as on the upper disc 15 over the main portion 27 of the
needle 17 in order to provide sufficient force to insert the angled
portion 28 of the needle. Once inserted, the adhesive layer 20 on the
underside of the bottom disc 14 securely fixes the needle patch 10 to the
skin 12 of the patient (see FIG. 3). Thereafter, the projection 24 may be
depressed manually so as to dispense the ointment 25 into the dam defined
by the annular wall 26 at the injection site.
Because of the transparency of the discs 14, 15, the injection site can be
readily viewed from time to time to check for sepsis. As a result, there
is no need to remove the patch 10 from a patient nor is there any need to
change any dressings from time to time.
Because adhesive layer 20 surrounds the injection site, the adjesive layer
20 serves as a barrier against contamination from the outside environment.
Hence, the injection site can be kept clean.
As indicated in FIGS. 3 and 4, the lower disc 14 is of a smaller thickness
than the upper disc 15. For example, the thickness of the lower disc may
be 0.005 inches while the thickness of the upper disc 15 is 0.060 inches.
The overall diameter of the discs 14, 15 may be about 1.750 inches.
The adhesive 20 should also be of such a nature as to form a relatively
fixed connection between the oatch 10 and the skin 12 of the patient so
that any lateral tugging of the tube 18 causes the tube 18 to neck down
before the patch 10 separates from the skin 12.
Of note, the needle 17 contains a continuous passage for the flow of a
fluid therethrough.
Referring to FIGS. 7 to 10, wherein like reference characters indicate like
parts as above, the needle patch 10' may be constructed to accommodate
different thicknesses of skin and different thicknesses of imolanted
access devices. In this respect, it is known that the combined thickness
of an implanted access device and the skin of a patient may vary
significantly from patient to patient. Hence, the upper disc 15 is
provided with an integral guide channel 34 to receive the main portion 27'
of the needle 17. As indicated in FIG. 7, the main portion 27' of the
needle 17 is initially horizontally disposed. Should the needle 17 bottom
within an access device 11 prior to securement of the patch 10' to the
skin of the patient, the needle 17 may pivot upwardly into a position as
illustrated in FIG. 10. The guide channel 34 is thus able to accommodate
the pivoting movement of the main needle portion 27'.
Of note, the guide channel 34 is disposed in spaced relation above the
needle 17 so as to avoid restraining upward movement of the needle 17. In
this respect, the total available travel for the needle may be just under
one quarter inch.
Alternatively, the needle 17' may be initially formed with an upwardly
angled needle portion with a depending portion 28' passing through the
aperture 22 in the lower disc 14 at a slight angle from a perpendicular
while the free end 29' is perpendicular to the plane of the disc 14. When
put to use, the finger pressure exerted on the needle 17' for insertion
causes the free end 29' of the needle 17 to first pierce the skin and the
underlying septum (not shown) of a vascular access device with a slight
pivoting or rotation movement.
While the transparent discs 14, 15 have been described as being flexible,
these discs may also be made of a relatively rigid material where such can
be applied to the skin of a patient.
The invention thus provides a needle patch which can be conveniently
inserted into a vascular access device implanted in a patient.
Further, the needle patch can be manufactured of relatively simple
materials in a relatively simple and inexpensive manner.
Further, the invention provides a needle patch which permits viewing of the
injection site and which does not require frequent changes of dressings.
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