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The present invention relates generally to infusion needle assemblies of
the type using a needle-attached member for guiding and holding an
infusion needle at its injection site, as exemplified by the needle
assemblies of prior U.S. Pat. Nos. 3,064,648 and 3,856,020, and more
particularly to improvements for the needle-attached member of such an
assembly which does not inhibit the proper and accurate placement of the
needle, and yet in use after such placement affords little or no
visualization of the needle beneath the patient's skin, with significant
beneficial pyschological effect on the patient. Said improvements are
noteworthy in other respects, as will be described in greater detail
subsequently.
It is already well known, as exemplified by prior U.S. Pat. No. 3,856,020,
that an injection or infusion needle can be effectively guided into
position by using as a finger grip a suitable member attached to the
needle. The prior art needle-attached member typically has wings or
lateral portions that are folded together and provide a convenient finger
grip by which the needle is readily manipulated preparatory to being
inserted into the patient. While generally effective, these prior art
grips rely on visualization of the needle protruding therefrom to assist
in the positioning thereof. Consequently, at the injection site there
continues to be visualization of the needle beneath the patient's skin,
which to some is psychologically upsetting, requiring the use of an
appropriate bandage covering or the like.
Broadly, it is an object of the present invention to provide an improved
infusion needle attachment overcoming the foregoing and other shortcomings
of the prior art. Specifically, it is an object to provide a
needle-attached member, by which an unseen needle, both during placement
and thus also when in its injected position, is nevertheless accurately
guided into said injected position.
As already noted, what is proposed herein is intended for use in
combination with an infusion needle for achieving subcutaneous placement
thereof incident to the dispensing therethrough of a medicament to a
patient. Said improvement is an infusion needle attachment, and the
embodiment thereof demonstrating objects and advantages of the present
invention includes a disk-like body of a selected size adequate for
delineating an operative area for making provision for the handling and
for the positioning of the infusion needle. A hollow tubular member
bounding a compartment for receiving said infusion needle is disposed in a
peripheral location in said operative area and at an angular orientation
in relation thereto so as to cause an infusion needle seated in said
compartment to project at said angular orientation in depending relation
from beneath the body. Further, in a medial location in said operative
area there is provided an upstanding finger grip means foldably attached
to the body along a line coincident with the center of the body and in
aligned relation to the projecting infusion needle. As a result of the
aligning orientations of the finger grip means and of the infusion needle,
it has been found to be a relatively easy task to effectively guide the
infusion needle into its required subcutaneous position even though the
body is in covering relation thereover masking the presence of the needle
during positioning. Said body also masks the needle after it has been
positioned.
The above brief description, as well as further objects, features and
advantages of the present invention, will be more fully appreciated by
reference to the following detailed description of a presently preferred,
but nonetheless illustrative embodiment in accordance with the present
invention, when taken in conjunction with the accompanying drawings,
wherein:
FIG. 1 is a perspective view of a prior art assembly of an infusion needle
and a cooperating attachment thereto intended to facilitate the
positioning of said needle;
FIGS. 2-5 illustrate the within improved attachment for facilitating the
positioning and handling of an infusion needle. More particularly, FIG. 2
is a perspective view illustrating an infusion needle with tubing in its
assembled condition to the within improved attachment for same;
FIG. 3 is a side elevational view of the assembly illustrating further
structural details; and
FIGS. 4 and 5 are front elevational views illustrating the infusion needle
and attachment in typical subcutaneous injected position within a patient,
FIG. 4 illustrating the grip of the attachment in its initial upstanding
condition, while FIG. 5 illustrates the said grip, as well as the
attachment per se, in its subsequent condition adhesively secured to the
patient.
It is already well known, as illustrated in FIG. 1 depicting the prior art,
that it is advantageous in placing an infusion needle 10 in a selected
injection site on a patient to use a needle-attached member 12 to more
conveniently handle and guide the needle into place. Prior art member 12
is typically of elastomeric construction material so that, as illustrated
in FIG. 1, lateral portions 14 and 16 thereof can be folded together and
gripped between the fingers, as illustrated, to contribute to facilitated
positioning of the needle. The assembly of needle 10 and attachment 12, as
just generally described, is more particularly described and illustrated
in prior U.S. Pat. No. 3,856,020, and is but one of many different types
of needle-attached members which are provided to facilitate the handling
and placement of infusion needles. Another prior patented assembly that is
worth mentioning, because it is believed to have been the first, is that
described and illustrated in prior U.S. Pat. No. 3,064,648.
Intended primarily as an improvement over the above referred to prior art
needle-attached members, there is described and illustrated herein a
member, also used in practice by being attached to an infusion needle,
that is capable, in a unique manner, of assuring the correct angle and
depth of penetration of the infusion needle in subcutaneous tissue.
Equally important, and as will be described in detail subsequently, the
within improved attachment for the infusion needle also effectively, at
the injection site, masks the needle from view and this, in practice, has
been found to provide a significant psychological advantage in obtaining
the patient's compliance with requirements which enhance the use of the
infusion needle for delivery of a medicament. That is, one of the
significant advantages of the within attachment is that in use there is
little or no visualization of the needle beneath the patient's skin, and
this has proven to have a significant beneficial psychological effect on
the patient.
To achieve the aforesaid and other benefits, there is provided according to
the present invention a member, generally designated 20, intended in its
contemplated use to be in attached relation to an infusion needle 22 which
itself is attached in an appropriate manner to tubing 24 which, in a well
understood manner, is connected to a reservoir, such as a syringe or
pouch, containing a source of medicament or fluid for subcutaneous
administration to a patient. Member 20, in a preferred embodiment, has a
disk-like body 24 which delineates an operative area on the upper surface
thereof, which area in terms of size and accessibility is both appropriate
and adequate for components, as will now be described, which facilitate
the referred to handling and placement of the infusion needle 22.
More particularly, one of the components is a tubular member 26 which,
critical to the within invention, is advantageously located at the
periphery of disk 24, as at 28, and is set at a selected angular
orientation, which is typically approximately 30 degrees, as illustrated.
The significance of the location 28 for the tubular member 28 is perhaps
best appreciated by reference to FIG. 3. More particularly, said
peripheral location 28 effectively locates the entire extent of disk 24
forward of the needle-receiving tube 26, and thus in an advantageous
position to mask the presence of the needle 22 which projects in depending
relation from beneath the disk 24. This is to be contrasted with what
exists in the prior art as illustrated in FIG. 1 wherein the prior art
needle 10 projects beyond the positioning member 12 and thus is visible at
the injection site unless, of course, it is otherwise masked from view by
a tape or bandage. In this connection, the presence of the injection end
of needle 10 in the patient is due primarily to the assembly of needle 10
in a central location of attachement 12, a location undoubtedly believed
necessary to use in order to enable the lateral portions or wings 14 and
16 to be gripped as in the manner illustrated in FIG. 1. It should be
noted that it is not an acceptable solution to merely enlarge the size of
member 12 so that it extends in covering relation over the prior art
needle 10, since this will produce an unwieldy and difficult-to-handle
size in the member 12.
As may perhaps best be appreciated from FIG. 2, the internal construction
for the tubular member 26 will be understood to consist of a through bore
30 sized to accommodate the cylindrical infusion needle 22 and a
larger-diameter counter bore 32 sized to accommodate a cylindrical tube
25. At the intersection of counter bore 32 with the through bore 30 there
is of course presented a shoulder 34 which, in a well understood manner,
during the injection of the assembly of needle and tube 22, 25 in the
internal compartment 30, 32 formed within the tubular member 26
effectively serves as a stop or seat 34 for the larger diameter tube 25.
Thus, shoulder 34 effectively limits the extent to which the infusion
needle 22 per se projects beyond the undersurface of the disk 24. As a
result, shoulder 34 thus effectively correspondingly limits the depth of
penetration of the infusion needle during its placement in subcutaneous
tissue 38.
Still referring to FIG. 3, it should also be readily appreciated that the
angular orientation of tubular member 26 is correspondingly imparted to
infusion needle 22, said angle, herein denoted by the reference numeral
36, being typically approximately 30 degrees.
Unlike the prior art attachment member used in the manner illustrated in
FIG. 1, member 20 hereof does not require the folding together of lateral
portions, an operational requirement which, in any event, would not be
particularly desirable since it might modify the angle of entry 36 of the
needle 22. Rather, and in accordance with the present invention, it is
more desirable that the angle 36 be maintained between the needle 22 and
the flat disk 24 so that the needle 22 is properly guided into its
injection position at said angle 36. Thus, in accordance with the present
invention, member 20 is provided with other gripping means. More
particularly, said means, designated 40, consists of a flap 40
advantageously located, as is perhaps best illustrated in FIG. 4, along a
line which is coincident with the diameter of the disk 24. Also as best
illustrated in FIG. 4, flap 40 and needle 22 are in aligned relation, and
this contributes to effective placement or guiding of the needle into an
infusion site, even though needle 22 is essentially hidden below the disk
24. That is, the plane of flap 40 is the same as that of needle 22 and
this the user is well cognizant of during placement of the needle, and is
thereby readily able to judge the exact location at which the point of the
needle 22 will make physical contact with the tissue 38.
After placement of the assembly 20 of the needle and its cooperating
attachment 22, 24, an adhesive strip 42 is advantageously placed
thereover, as in the manner illustrated in FIG. 5, to cause the folding of
flap 40 flat against the disk 24, and the disk 24 to take on or conform in
shape to the patient's anatomy at the injection site 38.
While the embodiment above described in connection with FIGS. 2-5 is
preferred, there are of course modifications that can be made thereto,
that are within the contemplation of the present invention. As an example,
disk 24 may be constructed to contain a pocket which should be filled with
a topical antiseptic which would come into direct contact with the user's
skin, and/or the construction material of the disk and flap 24, 40 could
be a suitable flexible plastic, rather than an elastomeric, and still
allow the folded and shape-conforming condition depicted in FIG. 5. Also,
to assist the adhesive strip 42 in holding disk 24 against the patient,
the bottom surface of the disk 24 can advantageously be provided with an
adhesive coat that is exposed, when needed during positioning, upon
removal of a backing strip. In other respects as well, a latitude of
modification, change and substitution is intended in the foregoing
disclosure and in some instances some features of the invention will be
employed without a corresponding use of other features. Accordingly, it is
appropriate that the appended claims be construed broadly and in a manner
consistent with the spirit and scope of the invention herein.
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