U.S. patent number 3,885,560 [Application Number 05/298,282] was granted by the patent office on 1975-05-27 for needle assembly having a folded bandage handle.
This patent grant is currently assigned to Affiliated Hospital Products, Inc.. Invention is credited to Brian E. Baldwin.
United States Patent |
3,885,560 |
Baldwin |
May 27, 1975 |
Needle assembly having a folded bandage handle
Abstract
A needle assembly including a needle having a pointed end, the
needle being removably secured to a flexible air breathable bandage
which is folded, the needle extending from one corner thereof in
the cross-folded form. The needle is provided with a flexible
connecting tube and a connector for attachment to a user device.
The flexible bandage forms a manipulable winged handle in the
initial folded form, and serves to enable the insertion of the
needle into a patient's body, after which the bandage is unfolded
and is adhered to the skin of the patient's body, preferably by
adhesion of a pressure sensitive adhesive surface on one face of
the bandage. In the unfolded form the bandage covers the puncture
site, and after needle use the needle may be removed while leaving
the bandage in place, leaving the puncture site covered by the
bandage.
Inventors: |
Baldwin; Brian E. (Wilmette,
IL) |
Assignee: |
Affiliated Hospital Products,
Inc. (St. Louis, MO)
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Family
ID: |
26719539 |
Appl.
No.: |
05/298,282 |
Filed: |
October 17, 1972 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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42713 |
Jun 2, 1970 |
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Current U.S.
Class: |
604/177; 604/305;
128/DIG.26 |
Current CPC
Class: |
A61M
25/02 (20130101); Y10S 128/26 (20130101); A61M
2025/0266 (20130101) |
Current International
Class: |
A61M
25/02 (20060101); A61m 005/00 (); A61m
025/02 () |
Field of
Search: |
;128/82,82.1,155,133,172,214,214.4,221,314,347-351,2.1R,2.06,DIG.4 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: McGowan; J. C.
Attorney, Agent or Firm: Pippin, Jr.; Reginald F.
Parent Case Text
This is a continuation, of application Ser. No. 42,713 filed June
2, 1970, now abandoned.
Claims
What is claimed is: That which
1. An attachable needle assembly for removable attachment to a body
member of a human or animal, comprising
a needle having a pointed end for insertion into a body member,
a flexible bandage including a multipurpose flexible securing sheet
having a pressure-sensitive adhesive securing surface adapted to
adhere to the skin surface of a needle-penetrable body,
said bandage, including its said securing sheet, being cross-folded
to form a folded winged handle for said needle, with four
fold-interconnected sections,
and means securing said needle to said flexible bandage-securing
sheet along a fold of said sheet, said needle extending beyond said
winged handle,
said securing sheet fold-interconnected sections each having an
adhesive securing surface with removable protective backing
thereon, the adhesive securing surface backing of two of said
sections facing outwardly away from one another, and the adhesive
securing surface backing of two other of said sections facing
inwardly toward one another in the cross-folded condition, and
being internal sections of said winged handle,
said two sections of said winged handle facing outwardly away from
one another being external sections, and their respective removable
protective backing forming manual engagement and gripping
surfaces.
2. An attachable needle assembly according to claim 1,
said winged handle comprising two wings folded about two lines
transverse to one another, one of said lines extending
substantially longitudinally of the lengthwise extent of said
hollow needle and the other of said lines extending substantially
transversely of the length of said needle.
3. An attachable needle assembly according to claim 2,
said fold lines intersecting substantially in the zone of a portion
of said needle.
4. An attachable needle assembly according to claim 3,
said fold lines including two adjacent folded layers of said
bandage having similar extending fold lines extending
longitudinally of said needle and having a fold line transverse to
both of said similarly extending fold lines and having a reverse
bend in a zone of intersection with said similarly extending
lines.
5. An attachable needle assembly according to claim 2,
said removable protective backing comprising a removable protective
cover sheet over the pressure-sensitive adhesive securing surfaces
of said wings surfaces to enable grasping and handling of said
wings as handles for insertion of said needle, and to prevent
bandage section inter-surface self-adherence between interfacing
section surfaces.
6. An attachable needle assembly according to claim 5,
said removable protective cover sheets being more stiff than said
flexible securing sheet to provide a stiff handle while enabling
relative ease of conformity of the securing sheet to a patient's
body, and to enable ease of removal of said cover sheets prior to
or during adhesive securing of said securing sheet to a body.
7. An attachable needle assembly according to claim 2,
said removable protective backing comprising removable protective
cover sheets over the pressure-sensitive adhesive securing surfaces
of said wings to enable grasping and handling of said wings as
handles for insertion of said needle.
8. An attachable needle assembly according to claim 1,
said needle being connected to a flexible connecting tube at its
end opposite said pointed end,
said needle being secured to said bandage by an overlay strip
encompassing a section of said flexible tube and secured to a
surface of said bandage.
9. An attachable needle assembly according to claim 8,
said overlay strip encompassing the zone of connection of said
needle with said flexible tube.
10. An attachable needle assembly according to claim 9,
said overlay strip being secured to said flexible securing sheet on
its surface opposite to said pressure-sensitive surface.
11. An attachable needle assembly according to claim 10,
said overlay strip being a tape removable from said flexible
securing sheet without destruction of said flexible securing
sheet.
12. An attachable needle assembly according to claim 8,
said overlay strip being secured to the surface of said flexible
securing sheet opposite to said pressure sensitive adhesive
securing surface,
said needle extending through an opening formed in a central zone
of said flexible securing sheet,
said central zone opening being formed at a fold corner of said
folded bandage.
13. An attachable needle assembly according to claim 1,
said needle extending through an opening formed in a central zone
of said bandage in unfolded form and lying at a fold corner of said
cross-folded bandage.
14. An attachable needle assembly according to claim 1,
said bandage having transverse quadrant-forming folds forming said
folded winged handle,
said needle extending from a fold corner of said bandage and
extending substantially longitudinal of one of said folds.
15. An attachable needle assembly according to claim 14,
said needle being secured to a face of said bandage.
16. An attachable needle assembly according to claim 15,
said needle being secured to a face of said bandage opposite said
pressure-sensitive adhesive securing surface,
and said needle extending through an opening formed at said fold
corner of said bandage.
17. An attachable needle assembly according to claim 15,
and a cover strip securing said needle to said pressure sensitive
adhesive securing surface of said bandages.
18. An attachable needle assembly according to claim 14,
said transverse folds forming two double-fold wings.
19. An attachable needle assembly according to claim 18,
said double-fold wings having a common fold line zone longitudinal
of said needle.
20. An attachable needle assembly according to claim 18,
said double fold wings having a common fold line zone transverse to
said needle.
21. An attachable needle assembly according to claim 1,
said needle being hollow,
a hollow tube secured to said needle at a central zone of the
unfolded form of said bandage,
and means for securing said tube to a fluid-use device.
22. An attachable needle assembly according to claim 1, said needle
forming an electrode for transmission of electrical signals to or
from a body into which it may be inserted.
23. A portable and manually manipulable needle and bandage assembly
unit for insertion in and adhering connection to a body member as a
unit, comprising
a folded flexible securing sheet forming a manually graspable
handle in its folded form and having intersecting cross-fold lines
formed by a first fold along one line and a second fold along a
line transverse to and intersecting said first fold forming at
least four fold-interconnected sections,
a pointed needle secured to said sheet and extending through an
opening formed in a central zone of said sheet at the intersection
of said fold lines and beyond its folded periphery,
said securing sheet having an adhesive surface on one face thereof
and a removable protective backing thereon,
said needle being removably secured to said foldable flexible
securing sheet on the face thereof opposite said adhesive surfaced
face.
24. A needle and bandage assembly according to claim 23,
said removable protective backing comprising plural protective
cover backing sheets removably adhered to said adhesive surfaced
face of said flexible securing sheet,
said protective cover backing sheets extending to and along and
adjacent at least one of said fold lines.
25. An assembly according to claim 23,
said flexible securing sheet being of air-breathing form.
26. An assembly according to claim 23,
and a removable securing strip removably securing said needle to
said flexible securing sheet,
said flexible securing sheet with its said adhesive surface and
said removable securing strip being air breathable to enable
breathing of a body surface onto which such securing sheet may be
attached.
27. An attachable freely manually manipulable and portable needle
assembly unit for removable attachment to a body, comprising
a needle having a pointed end,
a multifunction flexible bandage secured to said needle,
said flexible bandage including a flexible body-surface-conformable
cover sheet cross-folded transversely of and in the general
direction of the longitudinal extent of said needle to form at
least four fold-interconnected sections to enable ease of insertion
of said needle into a body, and for unfolded covering of a puncture
site formed upon insertion of said needle into a body member, as
well as for aid in securing of said needle to said body said needle
extending beyond said cross-folded sheet.
28. An attachable needle assembly according to claim 27,
said bandage having two wings folded about two lines transverse to
and intersecting one another, one of said lines extending
substantially longitudinally of and adjoining the lengthwise extent
of said hollow needle and the other of said lines extending
substantially transversely of and intersecting the effective
lengthwise extent of said needle.
29. An attachable needle assembly according to claim 27,
said bandage including two adjacent fold-interconnecting panels
each having fold lines extending longitudinally of said needle, and
having a further fold line transverse to both of said
longitudinally extending fold lines, said further fold line having
a rearward bend in a zone of intersection with said longitudinally
extending lines.
30. An attachable needle assembly according to claim 27,
said flexible bandage cover sheet having a surface with
pressure-sensitive adhesive material thereon,
and releasable protective sheets covering a major portion of said
pressure-sensitive adhesive material and being readily releasably
adhesively secured thereto.
31. An attachable needle assembly according to claim 30,
said flexible bandage cover sheet being formed of air breathable
porous material.
32. An attachable needle assembly according to claim 27,
said needle extending from a corner folded portion of said bandage
while said bandage is in the cross-folded form.
33. An attachable needle assembly according to claim 32,
said corner being the intersecting corner for two cross-folds of
said bandage.
34. An attachable needle assembly according to claim 30,
said releasable protective sheets being relatively stiffer than
said bandage cover sheet to provide a combined stiff manual handle
and a separated relatively more flexible and conformable said
bandage cover sheet.
35. An attachable needle assembly for removable attachment to a
body member of a human or animal, comprising
a needle having a pointed end for insertion into a body member,
a flexible bandage including a multipurpose flexible securing sheet
having a pressure-sensitive adhesive surface adapted to adhere to
the skin surface of a needle-penetrable body,
and means securing said needle to said flexible bandage securing
sheet,
said bandage, including its said securing sheet, being cross-folded
in at least four panels to form a folded winged handle for said
needle,
said securing sheet folded panels each having an adhesive securing
surface with removable protective backing thereon, the adhesive
surface backing of two of said folded panels facing outwardly away
from one another, and the adhesive backing surface of two other of
said folded panels facing inwardly toward one another in the
cross-folded condition,
said needle adjoining a fold zone of said bandage in the folded
condition of said bandage.
Description
This invention relates to an attachable needle assembly for
removable attachment to a body member, and more particularly to a
manually manipulable needle assembly for insertion into and
attachment to a patient's body, such as for intravenous therapy or
testing (using a hollow needle and fluid connection thereto), or
for electrical signal.
In the art of intravenous therapy it is necessary to insert a
needle into the vein of a patient, and to retain the needle in
place for an extended period of time, the time varying with the
particular intravenous therapy or testing involved. It has been
previously proposed and practiced to insert such intravenous
needles manually into the vein, as by holding the needle or needle
holder and puncturing the body, after which a strip of adhesive may
be applied to the needle to hold such in place. This method
requires the operator to have ready a strip of adhesive, and to
thereupon apply the adhesive while holding the needle in place.
While such is to some degree satisfactory, it has been found
desirable to provide better methods and arrangements for needle
insertion and attachment to the body.
One such prior arrangement is shown in U.S. Pat. No. 3,064,648,
which includes a needle with a semi-flexible plastic wing section
permanently connected to the needle and having weakened portions
which enable the plastic wing sections to be elastically folded to
form a manual handle. This device readily enables the manual
insertion of the needle. The subsequent securing of the needle to
the patient's body is accomplished by the employment of a strip of
adhesive tape which appears to be placed directly over the
down-folded wings to cover the wings and adhere to a portion of the
body adjacent the wings. This device does have the advantage of
providing a handle for the hand of the operator, but has a number
of distinct disadvantages, including the requirement for the
additional securing tape to be added thereto to secure the needle
assembly to the patient's body. In addition, this needle assembly
provides no self-contained portion for covering the puncture site,
and this leaves it to the operator to decide whether to cover this
site, although such in fact is desirable as an aid to prevention of
contamination. The device also tends to prevent skin breathing in
the zone over which the down-folded wings lie, as the wings are
formed of solid or continuous plastic material. There are also
distinct pressure points or zones at the edge junction of the wings
with the secure surface, and this edge junction also forms a
bacteria collection point inasmuch as the skin is depressed along
this zone by the tape-down of the plastic wings to the patient's
skin. The device also requires the removal or release of the
adhesive tape securing strip and the removal of the entire
attachable needle assembly, including the needle and plastic wings,
in order to remove the needle from the patient.
It is an object and feature of the present invention to provide an
attachable needle assembly which enables an operator to manually
manipulate, insert and secure the needle in place without touching
the needle, and which incorporates a multi-use bandage which serves
both as a manually manipulable handle for needle insertion and as a
needle securing bandage and site-covering bandage after insertion
of the needle.
It is still a further object and feature of the invention to
provide a manually manipulable needle and bandage assembly which
enables the ready manual insertion of the needle, the
self-contained securing of the needle to the body and the covering
of the puncture site by the bandage which initially enables manual
manipulation and insertion of the needle.
It is a further object and feature of the invention to provide a
manually manipulable wing-forming self-adhering bandage and needle
assembly which enables covering of the needle puncture site and
subsequent removal of the needle without removal of the bandage
from its covering of the needle puncture site, whereby the bandage
can be left in place and continue to provide effective cover for
the puncture site.
It is an additional object and feature of the invention to provide
a needle and bandage assembly, in which the bandage serves as a
manual handle in a folded form thereof, and subsequently serves as
a self-contained needle securing means in unfolded condition, and
in which the bandage has a pressure sensitive adhesive thereon for
ease of self-adhering attachment to a patient's body, the bandage
being formed of air breathable material for patient comfort and
minimization of skin irritation.
Still a further feature of the invention is the provision of a
combined needle and bandage arrangement which enables the bandage
to be adhered to a body to hold the needle in place after puncture
of the body by the needle with the aid of the bandage as a manual
handle, and which enables the needle to be easily removed from the
puncture site without requiring the bandage to be removed, either
simultaneously or prior to the removal of the needle, thereby
materially reducing the likelihood of vein damage which might
otherwise result from bandage arrangements where removal of the
needle requires removal of the adhered bandage.
Still other objects, features and attendant advantages will become
apparent to one skilled in the art from a reading of the following
detailed description of a preferred embodiment constructed in
accordance with the invention, taken in conjunction with the
accompanying drawings wherein:
FIG. 1 is a perspective view of one physical embodiment constructed
in accordance with the invention.
FIG. 2 is a view similar to that of FIG. 1, illustrating the device
in an upsidedown position for clarity of illustration of certain
parts.
FIG. 3 is a fragmentary longitudinal section view of FIG. 1 with a
cover sheath added.
FIG. 4 is a partially exploded view of the unfolded arrangement of
FIG. 1.
FIGS. 5 and 9-13 illustrate steps in the insertion and securing of
the needle assembly to a patient's arm.
FIGS. 6-8 illustrate optional pre-insertion manipulative steps.
FIGS. 14 and 15 illustrate steps in removal of the needle from the
patient's arm while leaving the bandage in place.
FIGS. 16 and 17 are perspective views of a modification of the
arrangement of FIG. 1.
FIGS. 18-20 illustrate steps in the securing of the modified
arrangement of FIGS. 16 and 17 to a patient's arm.
FIG. 21 is a perspective view of a further embodiment according to
the invention.
FIG. 22 is a partially exploded view of further embodiment
according to the invention.
Referring now in detail to the figures of the drawing, in the
embodiment of FIG. 1, a bandage and needle assembly 11 is provided
according to the invention, including a tubular needle 13 having a
point 13a which may have a beveled point configuration or otherwise
as may be desired, the needle being suitably connected at its rear
end to a length of flexible tubing 15 to which is also attached a
suitable connector 17 which may be employed for effectively
connecting the needle 13 and flexible tubing 15 to a desired user
device, such as a syringe, bottle, etc.
Needle 13 may be connected to flexible tubing 15 in any suitable
manner, as by frictional retention within the end of the tubing at
the junction therebetween, as indicated more particularly in FIG.
3. The exposed portion of the needle 13 may be suitably protected
against damage or premature contact, as by a tubular sheath cover C
slidably removably fitted thereover as indicated in FIG. 3.
Secured to the needle 13 and flexible tubing 15 is a multi-folded
bandage generally indicated at 21, which in its multi-folded form
serves as a handle for manual manipulation and insertion of the
needle 13 into a patient's body as may be desired. The bandage 21
includes a flexible securing sheet 23 which in its initial
multi-folded configuration has four quadrant portions 23a-23d
forming a winged handle.
The securing sheet 23 is preferably formed of air breathable sheet
material, which also preferably has a pressure sensitive air
breathable adhesive coating thereon, such as the pressure
sensitively adhering air breathable adhesive tape manufactured by
3M Company and sold under the brand name Micropore.
The four quadrant sections of the bandage securing sheet 23 are
indicated at 23a, 23b, 23c and 23d, the pressure sensitive adhesive
surface thereof being indicated by the reference character PSA.
In the embodiment and configuration of FIG. 1 the multi-folded
bandage 21 is cross-folded, first along a line transverse to the
needle 13, and thereupon along a line extending longitudinal of the
needle 13, the resulting multi-fold construction providing two
major wings which are themselves hinged at their forward ends to
form two sub-wings. The folds forming the sub-wings are indicated
at 23ab and 23cd, connecting respectively the quadrants 23a and 23b
and the quadrants 23c and 23d of the securing sheet 23.
Removably adhered to the adhesive face of each of the quadrant
sections 23a, 23b, 23c and 23d of the bandage securing sheet 23 are
protective release sheets 25a, 25b, 25c and 25d respectively. These
protective release sheets may take any suitable form, but are
preferably formed of material which is relatively rigid as compared
to the highly flexible securing sheet 23. This difference in
flexibility enables the securing sheet 23 to readily conform to the
varying external configuration of the body portion of the person,
without causing discomfort, whereas the more rigid protective
release sheet construction 25a -25d enables the multi-folded
bandage 21 to be employed as a relatively rigid handle for
manipulation of the needle 13 prior to and during insertion into
the body of the patient. In addition, in certain of the embodiments
the more rigid construction of the protective release sheets aids
in the removal thereof from the securing sheet 23 while
simultaneously adhering the securing sheet to the body of the
patient.
To this end, the protective release sheets 25a -25d may be suitably
formed of stiff paper preferably having a surface which will enable
light securing thereof to the pressure sensitive adhesive surface
PSA, but which will enable ease of release therefrom as by peeling
action. For example, the paper may be suitably coated with a
polyethylene, wax, or other suitable surface coating which will
enable ease of removal. Obviously, however, various protective
release sheet materials, other than these particular materials, may
be employed within the general ambit of the invention.
The protective release sheets 25a -25d may be provided with manual
gripping flaps 25a'-25d', respectively, if so desired, in order to
aid in direct manual removal of the releasable protective cover
sheets from the securing sheet 23.
Needle 13 extends outwardly from the cross-folded bandage 21
through a hole 23h formed at the corner of the bandage securing
sheet 23 formed by the intersecting cross-folds 23ab, 23cd, 23bc,
and 23ad. The point 13a of the needle 13 extends out a substantial
distance beyond the hole 23h, and the needle 13 and flexible
connecting tube 15 are removably secured to the bandage 21 through
the medium of a removable pressure sensitive tape 31, which is
likewise preferably formed of air breathable tape, such as
Micropore tape. Removable securing tape 31 is placed over the tube
15 and is in adhesive engagement with the upper surface of the
securing sheet 23 on both lateral sides of the tube 15, this upper
surface being the non-adhesive face of the sheet 23 opposite the
adhesive securing surface PSA. The hole 23h, preferably only a
small slit, may be pre-formed, or may be formed by direct insertion
of the needle 13 therethrough, with or without the protective
needle cover sheath C thereon, as may be desired.
In operation the operator will grasp the handle formed by the
cross-folded bandage 21, as indicated in FIG. 5, and will
manipulate the needle 13 to effect insertion of the needle into the
body of the patient, which in this illustration is an arm as
indicated at A. The needle will normally be inserted at a shallow
angle through a puncture hole, indicated at P, formed by pressing
the point 13a against the skin surface of the body portion
involved.
It is normally desirable that the needle be oriented to dispose the
bevel forming the point 13a in a direction away from the skin
surface, thereby presenting the sharp point directly adjacent the
skin surface. The present invention enables the operator to effect
this orientation of the needle 13 easily, without requiring manual
contact with the needle. This orientation manipulation of the
needle is illustrated in FIGS. 6-8, in which it will be noted that
the needle may be rotated clockwise or counterclockwise by manually
sliding the two major wing sections of the bandage 21 in opposite
directions respectively toward and away from the needle 13 axis,
the clockwise rotation being illustrated in FIG. 7 and the
counter-clockwise rotation being illustrated in FIG. 8. Thus, the
desired rotational orientation of the needle may be obtained for a
given geometrical insertion requirement.
Upon insertion of the needle 13 into the desired section of the
patient's body, as for instance into a vein, the needle may be
anchored in place through the succeeding bandage unfolding and
securing steps shown in FIGS. 9-12 to adhere the bandage securing
sheet 23 to the skin surface surrounding and overlying the wound
puncture site P. As shown in FIG. 9, after insertion of the needle
13 into the patient's body to a desired extent, the protective
release sheets are sequentially removed, as by grasping each with
the fingers of one hand and peeling such from the pressure
sensitive adhesive surface of its respective quadrant fold, the
first removal of such release sheet being effected while holding
down the opposite major wing section of the bandage with the
fingers of the other hand H1. Thus, the protective release sheet
23a is peeled off with one hand H2 while holding the needle and
bandage securely in place, with the other hand H1 and thereupon
quadrant 23a is smoothed into self-adhering contact with the skin
of the arm as by smoothing with the fingers of the hand H2 in
contact with the remaining protective release sheet 25b on the
overlying quadrant section 23b.
Thereupon, the operator may grasp the protective release sheet 25d
and peel such back from the quadrant segment 23d of the securing
sheet, and smooth this quadrant 23d into self-adhering contact with
the skin on the opposite side of the needle 13 and tube 15, as
illustrated in FIG. 10. The remaining two quadrant segments 23b and
23c of the securing sheet may now be secured to the skin surface,
by removal of the protective release sheets 25b, 25c as indicated
in FIG. 11, and thereupon incrementally rolling the two quadrant
segments 23b and 23c simultaneously forwardly into contact with the
skin on both sides of the needle puncture zone and the zone of
disposition of needle beneath the skin, as indicated in FIG. 12. It
will be noted that the puncture site P is thereby covered by the
bandage cover sheet 23, as illustrated in FIG. 13, and that the
needle 13 and tube 15 are secured in place, the needle being
retained at a relatively shallow angle, and the connecting tube 15
being substantially parallel with respect to the skin surface of
the arm A in the zone of securement. In this respect, it will be
noted that the tube 15 is retained in place in this condition by
the removable tape 31, and as this tape 31 is overlying a part of
the securing sheet 23a it is preferable that the tape 31 be
likewise formed of pressure sensitive material which is air
breathable, and which may be similar to that material forming the
adhesive cover sheet 23.
Upon anchoring of the needle and bandage assembly 13, 15, 23, the
operator may thereupon connect the needle 13 and tubing 15 to a
user device, such as a syringe S, by mating connection with the
connector 17. Insertion or withdrawal of fluid or other materials
may be thereupon accomplished over such period of time as may be
desired.
After accomplishment of the desired operation with the needle 13 in
place, the needle assembly may be removed in its entirety without
necessatating removal of the bandage cover sheet 23. It is only
necessary for the operator to pull the pressure sensitive tape 31
from its anchoring contact with the outer surface of the cover
sheet 23, as shown in FIG. 14, thereby releasing the needle 13 and
tube 15 from its anchored relation with the cover sheet 23. The
needle may thereupon be withdrawn as indicated in FIG. 15, by
grasping the tube 15 at the zone of connection thereof with the
needle 13 and pulling on the needle along its longitudinal axis,
thereupon removing the needle from the puncture site P and through
the hole 23h. The operator may thereupon smooth down the
needle-outline ripple remaining in the bandage surface between the
zone of the puncture P and the hole 23h, thus adhesively securing
the cover sheet 23 around the total periphery of the puncture P and
providing continuing bandaged protection for the puncture wound,
for such time as may be desirable. At any time as may be desired,
the bandage cover sheet 23 may be removed by peeling such from the
skin surface.
A modified arrangement 111, without pickup flaps 25a' - 25d', is
shown in FIGS. 16 and 17, which provides less bulkiness to the
bandage handle in the cross-folded initial form and which enables
simpler manufacture of the bandage portion of the unit, thus
providing some advantages over the first embodiment, although the
advantages of pickup flaps 25a' - 25d' are to some extent
sacrificed and must be compensated for during application. In this
embodiment, the cover sheet 23, needle 13, tube 15, connector 17
and removable securing strip 31 may be identical to the
counterparts illustrated and described in the foregoing embodiment
of FIG. 1. The protective release sheets 125a-125d are, however,
modified so as not to include a folded flap thereon as indicated at
25a' - 25d' in the first embodiment. This elimination of these
flaps provides substantially less bulkiness in the fold zone along
the enfolded longitudinal extent of the needle and tube, to some
extent renders the accomplishment of the needle orientation
manipulation of FIGS. 6-8 easier, renders manufacture of the
bandage 121 easier, as the extra fold flaps need not be formed and
permits the protective release sheets 125a-125d to be of thicker
and/or more stiff material.
In this embodiment, after insertion of the needle 13 into the
patient's body, one of the two major dual quadrant wing sections of
the handle formed by the bandage 121 is unfolded down against the
skin and held in place by one hand, while the other hand is used to
incrementally roll the opposite major dual quadrant wing of the
bandage away from the line of the needle and tube. In this respect,
it is to be remembered that the protective release sheets 125a-125d
are formed of readily releasable material, such as polyethylene
coated or other suitably coated paper or other material which
enables ease of release from the pressure sensitive adhesive
surface, and in addition the protective release sheets 125a -125d
are relatively stiff as compared to the highly flexible adhesive
securing sheet 123. In view of this differential stiffness of the
bandage securing sheet 123 and the protective release sheets
125a-125d, flexing of the bandage near the edge of the release
sheet will tend to separate the protective release sheet from the
securing sheet adhesive surface. Accordingly, by initially flexing
the free end of the combined dual quadrant wing made up of securing
sheet quadrants 123a, 123b and protective release sheets 125a,
125b, laterally toward the opposite held-down wing section, the
protective release sheet 125a will be separated from the adhesive
surface of the cover sheet quadrant 123a in the zone adjacent the
tube and needle. Thereupon the operator may incrementally roll-bend
the wing section laterally away from the needle and tube, to
incrementally remove the protective release sheet 125a from the
respective quadrant 123a pressure sensitive adhesive surface. The
protective release sheet 125a is thereby effectively removed while
at the same time the operator is smoothing the cover sheet quadrant
123a into adhesive contact with the skin. Next, the opposite
securing sheet quadrant 123d is adhered to the skin in the same
manner, while incrementally removing the protective release sheet
125d during the smoothing and adhering action of the securing sheet
quadrant 123d to the skin surface, as shown in FIG. 19. Thereupon,
as shown in FIG. 20, the protective release sheets 125b and 125c
are removed while incrementally rolling and smoothing of the
respective quadrants 123b and 123c into adhesive contact with the
skin, around, over and beyond the puncture site P. It will in this
respect be appreciated that inasmuch as these two quadrant-covering
protective release sheets 125b and 125c are simultaneously removed
in the step of FIG. 20, such may be formed as a single sheet,
instead of as two sheets as shown. After completion of removal of
the protective release sheets 125b, 125c, and adhering of the
corresponding bandage cover sheet quadrants 123b, 123c to the skin
surface, the needle and bandage assembly is in the secured
condition as previously shown at FIG. 13.
A further modification is illustrated in FIG. 21, in which the
initial folded condition of the first embodiment is modified. In
this modified folded arrangement, the two major wing sections of
the bandage 221 forming the handle for the needle and bandage
assembly are folded about an axis which is transverse to the length
of the needle, whereas in the first and second embodiments the fold
axis of the two major wings of the bandage handle extends
longitudinally with the needle. Thus, in this embodiment the
quadrants are first folded about a fold line extending longitudinal
of the needle, and are thereupon folded about a fold line normal to
the needle, to assume the configuration shown in FIG. 21. While
this embodiment is satisfactory from the standpoint of enabling the
bandage 221 to serve as a handle for insertion of the needle into
the patient's body, it will be appreciated that this embodiment is
materially less advantageous than the prior embodiment in rendering
it substantially more difficult to rotate the needle about its
longitudinal axis by manipulation of the folded bandage wings.
After insertion of the needle of this embodiment, the quadrants are
secured to the skin of the patient by first unfolding the wing
sections 23b, 23c in a counter-clockwise direction as shown in FIG.
21 to bring such into substantial parallelism with the needle and
the other two quadrants 23a, 23d. Thereupon, the quadrants may be
sequentially secured to the skin in paired relation 23c, 23d and
23a, 23b.
FIG. 22 illustrates a further modification which may be employed in
some instances, although such is materially less preferred and less
advantageous than the other described embodiments. In this
embodiment, the needle 13 and tube 15 are secured to the bandage
cover sheet 323 by a securing strip 331 adhered to the pressure
sensitive surface PSA of the cover sheet 323. Thus, the needle does
not pass through a hole in the cover sheet 323, as in the
preceeding embodiments of FIGS. 1 and 16. This gives the advantage
of providing a continuous bandage over the entire needle and
adjoining tube section. However, this arrangement is materially
less advantageous than the previously described arrangements of
FIGS. 1 and 16, which incorporate a tiny needle-entrant hole in the
adhesively secured cover sheet, with a removable securing strip on
the upper surface thereof, for with the present embodiment of FIG.
22 the placement of the securing strip 331 on the lower adhesive
surfaced face of the cover sheet 323 effectively prevents removal
of the needle and tube from the puncture site without substantially
simultaneous removal of the adhesively secured cover sheet 323.
This is a material disadvantage common to the prior art, and will
in most instances render the embodiment of FIG. 22 undesirable,
particularly in view of the difficulty in preventing vein damage in
removal of the needle of this embodiment.
While the invention has been illustrated and described with respect
to several illustrative embodiments, it will be appreciated that
various modifications and improvements may be made by those skilled
in the art without departing from the scope and spirit of the
invention. For instance, the invention may be employed as an
adjunct to the application and/or sensing of electrical signals to
or from a patient's body, in which instance the needle may be a
pointed metal electrode needle, and the flexible tube 15 may be or
contain a flexible connecting wire which is capable of conducting
electrical signals to or from the needle, and which may be
connected to a suitable electrical signal supply and/or sensing
apparatus. Also, while the folded bandage is shown and preferred to
be cross-folded, and has four relatively equal folds, such is not
restricted to cross-folding, four folds, or to equality of the
folded segments of the securing sheet. Also, the protective release
sheets may take various shapes forms and constructions. In
addition, the general method of bandage application for the
embodiment of FIG. 16 may also be used with other embodiments, such
as with the embodiments of FIGS. 1, 21 and 22 if so desired.
Further, while definitely less advantageous and not preferred, the
cross-folded bandage and needle arrangement may be employed without
self-adhesive thereon, using extra adhesive tape or tapes for
securing in place while still providing the material advantage of
an initial folded winged handle and the self-coverage of the
puncture site after needle insertion and wing unfolding of the
bandage. Accordingly, the invention is not to be limited by the
particular illustrative embodiments, but only by the scope of the
appended claims.
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