U.S. patent application number 12/643365 was filed with the patent office on 2010-04-22 for container for disposable needle or cannula.
This patent application is currently assigned to Unomedical A/S. Invention is credited to Mario Cane.
Application Number | 20100100050 12/643365 |
Document ID | / |
Family ID | 11459357 |
Filed Date | 2010-04-22 |
United States Patent
Application |
20100100050 |
Kind Code |
A1 |
Cane; Mario |
April 22, 2010 |
CONTAINER FOR DISPOSABLE NEEDLE OR CANNULA
Abstract
The present invention relates to a container for a disposable
needle or cannula, intended to facilitate needle or cannula
placement for the infusion of a liquid drug under a patient's skin,
the container comprising: a cylindrical housing (1; 101) in which
there are defined a cap (1a; 101a) and a sleeve (1b; 101b) provided
with a resting base (1c; 101c), said cap (1a; 101a) being axially
slidable relative to said sleeve (1b; 101b) when a sufficient
pressure is exerted on said cap (1a; 101a); a needle (21; 121) or
cannula, which is located inside said housing so as to be directed
towards said resting base (1c; 101c) for the infusion of the drug;
a retaining member (9; 109), which is located within said housing
(1; 101) between said cap (1a; 101a) and said sleeve (1b; 101b) and
to which said needle (21; 121) or cannula is secured; said
container being equipped with a releasing member for releasing said
needle (21; 121) or cannula when said cap (1a; 101a) is made to
slide on said sleeve (1b; 101b).
Inventors: |
Cane; Mario; (Collegno (To),
IT) |
Correspondence
Address: |
BRINKS HOFER GILSON & LIONE
P.O. BOX 10395
CHICAGO
IL
60610
US
|
Assignee: |
Unomedical A/S
Birkeroed
DE
|
Family ID: |
11459357 |
Appl. No.: |
12/643365 |
Filed: |
December 21, 2009 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
12166693 |
Jul 2, 2008 |
|
|
|
12643365 |
|
|
|
|
10872423 |
Jun 22, 2004 |
7407493 |
|
|
12166693 |
|
|
|
|
Current U.S.
Class: |
604/180 ;
604/182 |
Current CPC
Class: |
A61M 5/3243 20130101;
A61M 2005/1585 20130101; A61M 2005/1581 20130101; A61M 5/158
20130101 |
Class at
Publication: |
604/180 ;
604/182 |
International
Class: |
A61M 5/32 20060101
A61M005/32 |
Claims
1-22. (canceled)
23. A container for facilitating insertion of a piercing member
through a patient's skin, the container comprising: a housing
comprising a cap and a sleeve, the cap being axially slidable
relative to the sleeve to substantially encase an axial length of
the sleeve when sufficient pressure is exerted on an exterior
surface of the cap; the sleeve defining a base for placement
against the patient's skin; a retaining member connected to the
cap; the piercing member connected to the retaining member; wherein
the piercing member is concealed within the sleeve in a first
housing position wherein a portion of the axial length of the
sleeve is unencased by the cap and the piercing member exposed from
the sleeve in a second housing position wherein the cap
substantially encases the axial length of the sleeve; and a
releasing member for releasing the piercing member from the
retaining member; wherein upon exertion of the pressure on the cap,
the cap slides axially toward the patient's skin along said sleeve
so that the piercing member is placed through said patient's skin
and the piercing member is released from the retaining member.
24. The container of claim 23, wherein the sleeve further comprises
a pair of guiding members to guide the cap relative to the sleeve
when the cap is depressed.
25. The container of claim 23, further comprising a projecting
structure defining the retaining member and extending generally
axially from an end portion of the cap within said sleeve.
26. The container of claim 25, wherein the piercing member is
attached to the projecting structure.
27. The container of claim 23, wherein the releasing member
comprises a pair of projections configured to contact the sleeve to
release the piercing member when the cap is depressed.
28. The container of claim 27, wherein the pair of projections
comprises a first configuration when the cap is in the first
position and the pair of projections comprises a second
configuration when the cap is in the second position, wherein the
pair of projections are moved inward in the second
configuration.
29. The container of claim 23, further comprising a releasable
annular protector surrounding at least a portion of the sleeve to
prevent the cap from sliding relative to the sleeve.
30. The container of claim 23, wherein the container is
cylindrically shaped.
31. The container of claim 30, wherein the adhesive layer is
releasably attached to the base and configured to adhere to and
remain on the patient's skin after the container is removed.
32. The container of claim 30, wherein the adhesive layer comprises
an opening for extension of at least a portion of the piercing
member therethrough.
33. The container of claim 23, wherein the piercing member is
adapted to administer a drug.
34. A container for facilitating placement of a medical device
through a patient's skin, the container comprising: a housing
comprising a cap telescopically sildable over a sleeve, the sleeve
including a base configured for placement against the patient's
skin; at least one guiding member to guide the movement of the cap
relative to the sleeve between a first position to a second
position along the sleeve; a piercing member secured to a retaining
member within the housing, the piercing member and the retaining
member movable together with the cap toward the second position
wherein at least a portion of the piercing member is exposed from
the sleeve and the cap substantially encases an axial length of the
sleeve; and a releasing member for releasing the piercing member
from the retaining member, the releasing member being activatable
to release the piercing member from the retaining member by
movement of the cap from the first position to the second position;
wherein upon exertion of pressure on the cap, the cap slides
axially toward the patient's skin along the sleeve to the second
position so that the piercing member is placed through the
patient's skin.
35. The container of claim 34, wherein an adhesive layer is
releasably attached to the base and configured to adhere to and
remain on the patient's skin after the container is removed.
36. The container of claim 34, further comprising a releasable
annular protector surrounding at least a portion of the sleeve to
prevent the cap from sliding relative to the sleeve.
37. The container of claim 34, further comprising a plurality of
guiding members to guide the cap relative to the sleeve when the
cap is depressed.
38. The container of claim 37, wherein the plurality of guiding
members project inward into an interior cavity defined within the
sleeve.
39. The container of claim 34, wherein the releasing member
comprises a plurality of flexible members configured to deform
inwardly into an interior of the container when the cap is made to
slide on the sleeve.
40. The container of claim 34, wherein the sleeve further comprises
an axial slit.
41. The container of claim 35, further comprising a protective film
for covering a face of the adhesive layer prior to adhering the
adhesive layer to the patient's skin.
42. The container of claim 34, wherein the retaining member is
connected to the cap.
Description
[0001] The present invention relates to a container for a
disposable needle. More particularly, the invention refers to a
container for a disposable needle for drug infusion, which
container makes needle placement through a patient's skin
easier.
[0002] As known, several medical treatments exploit subcutaneous
infusion of liquid drugs: the drug flows through a hose connected
to a needle placed through the patient's skin and it is directly
delivered under the skin through said needle. Alternatively,
insertion needles are employed for placement through the patient's
skin of a soft and relatively flexible tubular cannula, followed by
insertion needle removal and subsequent infusion of medical fluid
to the patient directly through the cannula. In some cases, the
patient himself/herself is to administer the drug. For instance,
many diabetic patients self-administer insulin, in the form of
controlled and prolonged infusion.
[0003] Clearly, many patients have no medical knowledge and
therefore they may be reluctant to place the needle or cannula
through their skin or inexpert in doing so. Thus, it is necessary
to provide means allowing automatic placement, so as to prevent the
patient's lack of skill or hesitation from resulting in an
incorrect needle or cannula placement, with possible dangerous
consequences.
[0004] Devices of this kind, which can be employed for the
subcutaneous infusion of a liquid drug either through a needle or
through a soft cannula, already exist and one of them is disclosed
in patent U.S. Pat. No. 6,093,172.
[0005] According to the teaching of the above mentioned patent, a
device for needle placement comprises a cylinder, the lower portion
of which can receive the outward-directed needle and related hose,
ready for placement through the patient's skin. Said cylinder
internally includes a spring that can be brought into a loaded
condition and, on its upper portion, a trigger that is to release
said spring. By depressing the trigger, the spring is released so
as to outward project, more particularly through the patient's
skin, the needle located in the lower portion of the device. Once
the needle is placed through the skin, a slight traction is
sufficient to retract the device and leave the needle in place, in
the correct position.
[0006] A problem with such kind of devices is that the patient is
to provide for the correct introduction of the infusion set into
the lower portion of the cylinder, to ensure a correct needle
positioning.
[0007] It is a main object of the present invention to provide a
container within which a needle and the related hose or,
alternatively, a cannula, are already correctly positioned, so that
the patient only has to place said container against his/her skin
and to release the needle or cannula through a simple movement.
[0008] Another drawback of such known devices is that, while the
needle is being placed inside the device, the user risks to prickle
himself/herself while handling the needle. Moreover, at such step,
the needle is exposed to the outside environment and in particular
to germs and bacteria.
[0009] Thus, it is another object of the present invention to
provide a container for a disposable needle or cannula that does
not result in the risk for the user to prickle himself/herself
during use and that allows maintaining hygiene and safety in
respect of possible contamination by external agents.
[0010] A container for a disposable needle according to the
preamble of claim 1 is disclosed in U.S. Pat. No. 6,093,172.
[0011] The above and other objects of the invention are achieved by
a container as defined in the appended claims.
[0012] The container according to the invention has the appearance
of a small housing of plastic material, already containing the
needle connected with the related hose or, alternatively, the end
of the cannula connected with the related insertion needle, and
protected from the surrounding environment by means of a protecting
film.
[0013] After said film has been removed and the container base has
been placed against the skin, a simple push is sufficient to
release the needle and pierce the skin.
[0014] Once the needle has been placed through the skin, the
container can be removed by slightly pulling it, without risks of
to displacing the needle from the correct position.
[0015] If the drug is to be delivered to the patient directly
through a soft cannula, the insertion needle of said cannula can be
removed together with the container, without displacing the
cannula.
[0016] Advantageously, the construction of a disposable device
affords maximum simplicity of use and maximum hygiene.
[0017] A number of embodiments of the invention will be disclosed
in greater detail with reference to the accompanying drawings,
wherein the container according to the invention is employed for
the insertion of a needle through a patient's skin. However, as
already mentioned, the container according to the invention can be
similarly used for the insertion of a soft cannula through a
patient's skin.
[0018] In the accompanying drawings:
[0019] FIG. 1 is a side view of the container according to a first
embodiment of the invention, shown before use;
[0020] FIG. 2 is a cross-sectional view taken along line A-A in
FIG. 1;
[0021] FIG. 3 is a cross-sectional view taken along line A-A in
FIG. 1, after needle insertion;
[0022] FIG. 4 is a cross-sectional view taken along line B-B in
FIG. 2;
[0023] FIG. 5 is a cross-sectional view taken along line C-C in
FIG. 2;
[0024] FIG. 6 is a top view of the container according to said
first embodiment of the invention;
[0025] FIG. 7 is an overall perspective view of the container
according to a second embodiment of the invention, shown before
use;
[0026] FIG. 8 is an exploded view of the container shown in FIG.
7;
[0027] FIG. 9 is a plan view of the needle-retaining member in the
container shown in FIG. 7, shown before assembling;
[0028] FIG. 10 is a side view of the needle-retaining member shown
in FIG. 9; and
[0029] FIG. 11 is a cross-sectional view, taken along line D-D, of
the needle-retaining member shown in FIG. 9.
[0030] Referring to FIG. 1, the container according to a first
embodiment of the present invention comprises a cylindrical housing
1, in which there is defined a cap 1a axially slidable relative to
a sleeve 1b when a sufficient pressure is exerted on said cap
1a.
[0031] Said cap 1a moreover has an inner diameter slightly
exceeding the outer diameter of sleeve 1b, so as to allow sleeve 1b
to be received within cap 1a when the latter has been wholly
depressed.
[0032] Sleeve 1b is integral with a base 1c intended for placing
the container against the patient's skin, in the area where a
L-shaped needle is to be inserted.
[0033] A hose 11, intended to supply the needle located within
housing 1 with the drug, as it will be better disclosed
hereinafter, radially comes out from sleeve 1b through an axial
slit 63.
[0034] It is to be noted that said L-shaped needle with its related
hose can be replaced by a soft cannula provided with an insertion
needle of the type shown above captioned patent U.S. Pat. No.
6,093,172. Said cannula is a hollow tube made from a soft and
flexible material, which can be bent into a desired configuration.
In order to insert the cannula through a patient's skin, an
insertion needle is introduced in the free end of the cannula and
used for piercing the patient's skin and driving through the
patient's skin said end of said cannula. The insertion needle is
then removed, the cannula is bent into a L-shaped configuration for
purpose of practicalness so as to adhere to the patient's skin and
the drug is infused through the cannula. It is evident that, within
the scope of the invention, the above disclosed cannula, together
with the associated insertion needle, is equivalent to the
aforesaid L-shaped needle and, for this reason, it will not be
further described.
[0035] Outside housing 1, a removable film 3 is applied onto base
1c, to protect an adhesive gauze 5 placed between said film and
base 1c and weakly adhering to base 1c in correspondence of a set
of circular portions 7.
[0036] Referring now to FIG. 2, the container according to said
first embodiment of the invention comprises, within said housing 1,
a retaining member 9 comprising a securing portion 9a directed
towards cap 1a and a retaining portion 9b directed towards sleeve
1b.
[0037] Securing portion 9a is firmly held inside an axial
cylindrical hub 10 extending within cap 1a and integral therewith.
Retaining portion 9b axially extends inside the container and ends,
at its end remote from said securing portion 9a, with a plate 13
transversally arranged relative to the axis of retaining member
9.
[0038] As better shown in FIG. 4, said plate 13 has a substantially
circular shape and has a pair of diametrically opposite radial
grooves 15, through which corresponding axial projections 17 formed
within sleeve 1b pass. Said projections are arranged to guide the
axial sliding of plate 13, and consequently of member 9, when cap
1a is pressed against sleeve 1b.
[0039] Still with reference to FIG. 4, said plate 13 further
comprises a groove 19, diametrically crossing the whole plane of
plate 13, perpendicularly to radial grooves 15. Groove 19 retains
inlet branch 21a of an L-shaped needle 21 for the infusion of the
drug, housed inside the container.
[0040] Turning back to FIG. 2, said groove 19 axially extends
inside plate 13 and retaining element 9b and widens, at its end,
into a radial hollow 23, thereby to define two diametrically
opposite portions of said plate 13. As it will be explained
thereinafter, said portions can be deformed to release needle 21
once cap 1a has been depressed.
[0041] Two circumferential rims 25 and 27, respectively, are formed
on the internal wall of sleeve 1b to keep plate 13 in engagement
against sleeve 1b, thereby preventing cap 1a from sliding until a
force sufficient to overcome the resistance of outermost rim 25
relative to said cap 1a is exerted against said cap.
[0042] With reference to FIG. 5, the internal wall of sleeve 1b
comprises an axial groove 31 housing outlet branch 21b of L-shaped
needle 21.
[0043] Said sleeve 1b further has, at the end of said axial groove
31, a widened portion 41 in correspondence of base 1c, to prevent
branch 21b of needle 21 from sticking into the wall of sleeve 1b
while advancing towards the outside through opening 37 provided in
gauze 5. Cap 1a has a corresponding widening 43 to receive the
outer projection defined by said widened portion 41 when sleeve 1b
is completely received within cap 1a.
[0044] Turning back to FIG. 2, retaining portion 9b further
comprises a pair of diametrically opposite fins 33 upward
projecting from plate 13 and diverging towards cap 1a. Said fins 33
end with a convex portion 35, interfering with axial projections 17
when cap la is depressed and retaining member 9 is made to slide
along sleeve 1b, thereby disengaging plate 13 from rim 25 and
bringing the container to the position shown in FIG. 3.
[0045] Referring now to FIG. 3, when cap 1a is completely lowered
against sleeve 1b, retaining member 9 is arranged with plate 13
against the inner face of gauze 5, and branch 2 1b of L-shaped
needle 21 will be completely placed through the patient's skin
after having passed through opening 37 in gauze 5.
[0046] Referring now to FIG. 6, gauze 5 is joined to a second
adhesive gauze 39, which in turn is protected by a respective
removable adhesive film. The border of second gauze 39 can be
folded on gauze 5 when needle 21 has been inserted and the
container has been removed. Thus, the patient can advantageously
cover the area of gauze 5 and branch 21a of L-shaped needle 21 by
said second gauze 39, whereby only the border of gauze 39 is
externally visible and the area occupied by the needle is thus
protected.
[0047] The operation of the container according to said first to
embodiment is as follows: starting from the configuration shown
in
[0048] FIG. 2, protecting film 3 is removed and adhesive gauze 5 is
made to adhere to the patient's skin in the area where needle 21 is
to be inserted. Pushing cap 1a towards base 1c results, once the
resistance of rim 25 has been overcome, in the release of plate 13
and the sliding of cap 1a on sleeve 1b. During this step, needle 21
is placed through the patient's skin and, at the same time, is
released from retaining member 9 because of the deformation of
plate 13 due to the pressure radially exerted by projections 17
onto fins 33. The container has thus taken the configuration shown
in 20' FIG. 3 and it can be removed, while leaving the needle in
place thanks to the weak adhesion between base 1c and gauze 5 if
compared with the adhesion between gauze 5 and the patient's skin.
Subsequently, the protecting film of second gauze 39 can be removed
therefrom and gauze 39 can be folded on and made to adhere to gauze
5.
[0049] Referring now to FIGS. 7 to 11, a second embodiment of the
invention is shown, which differs from the first embodiment in
particular in respect of the structure of the needle-retaining
member.
[0050] In this second embodiment, the container comprises a
cylindrical housing 101, in which a cap 101a and a sleeve 101b are
defined. The sleeve has a slightly smaller diameter, so that, when
a sufficient pressure is exerted on cap 101a, the latter is axially
slidable relative to sleeve 101b and can internally receive the
sleeve. Said sleeve 101b is integral with a base 101c intended for
placing the container against the patient's skin.
[0051] Slightly projecting circumferential rims could be provided
on the inner surface of the base of cap 101a and on the outer
surface of the edge of sleeve 10 1b remote from base 101c,
respectively. Thanks to the co-operation between said
circumferential rims, when housing 101 is assembled, said cap 101a
is axially slidable to on sleeve 101b but it cannot be accidentally
separated therefrom.
[0052] Moreover, an annular band, e. g. of plastic material, could
be applied around sleeve 101b to prevent cap 101a from accidentally
sliding relative to sleeve 101b. Said band can be easily removed by
the user before use.
[0053] A hose 111 radially comes out from sleeve 101b through an
axial slit 163. Said hose is intended to deliver the drug to an
L-shaped needle 121, located within housing 101 and comprising an
inlet branch 121a, onto which the hose is fitted, and an outlet
branch 121b, intended to be at least partly placed through the
patient's skin. Said L-shaped needle 121 is housed within a
retaining member 109, contained within housing 101.
[0054] Said retaining member 109 comprises a securing portion 109a
and a retaining portion 109b and consists of two coupled
half-shells 109c, shaped so as to define therebetween a cavity 161
capable of receiving said needle 121.
[0055] Securing portion 109a comprises two shoulders 157, 159,
which are received into corresponding recesses 165, 167 formed in
the edge of sleeve 101b remote from base 101c.
[0056] More particularly, recess 165 formed in correspondence with
slit 163 is so sized that its edges resiliently press against
shoulder 157 of retaining member 109, whereas the opposite recess
167 is oversized with respect to the corresponding shoulder 159 in
said member 109, so that a clearance is left.
[0057] In the alternative, a pair of facing resilient members could
be formed on the internal surface of said sleeve 101b, which
members radially project towards the centre of said sleeve to such
an extent that they press against half-shells 109c of said member
109.
[0058] Advantageously, radial projections 166, 168 are provided on
the inner surface of sleeve 101b in correspondence with recesses
165, 167 and are firmly held between said shoulders 157, 159 and
corresponding teeth 158, 160 formed in securing portion 109a of
said retaining member 109. In such manner, retaining member 109 is
axially joined to sleeve 101b.
[0059] Furthermore, a recess 155, extending up to cavity 161, is
defined in securing portion 109a, to receive a projection 151
centrally provided inside cap 101a. Preferably, end 153 of said
projection 151 is so shaped that it conforms to the curved profile
of hose 111.
[0060] Two facing L-shaped axial projections 169, diametrically
opposed and parallel to slit 163, are provided inside sleeve 101b
and they form a seat for the portion of said retaining member 109
receiving outlet branch 12 1b of needle 121.
[0061] FIGS. 9 to 11 show in detail retaining member 109.
Advantageously, said retaining member 109 consists of two facing
half-shells 109c, whereby positioning of needle 121 is particularly
easy: indeed, it will be sufficient to place said needle between
said half-shells 109c and then to join them, thereby blocking the
needle therebetween. Said half-shells 109c are preferably formed by
moulding into a single element, and therefore they are
advantageously joined by a flexible member 171 making their
assembling easier.
[0062] One of said half-shells 109c comprises three pins 173
engaging corresponding holes 175 in the other half-shell 109c,
thereby assisting in correctly aligning both half-shells 109c at
the assembling and, subsequently, in keeping them joined.
[0063] Both half-shells 109c have a groove 161a, 161b defining
cavity 161 when half-shells 109c are joined.
[0064] Inlet branch 121a of needle 121, on which hose 111 is
fitted, is retained inside cavity 161 thanks to the co-operation
between a pair of support projections 177, 178 and a pair of rigid
tongues 181 provided on one of half-shells 109c and housed in
respective seats 179 in the other half-shell.
[0065] One of said support projections, 178, is suitably arranged
on one half-shell 109c in correspondence of the bend between inlet
and outlet branches 121a, 12 1b of needle 121. When the retaining
member 109 is assembled, said projection 178 prevents, by
co-operating with the surface of the facing half-shell 109, needle
removal from housing 101.
[0066] As shown in FIG. 11, retaining portion 109b of each
half-shell 109c is divided into two sections 109d, 109e connected
by a flexible connecting member 183 allowing limited relative
displacements of said sections.
[0067] When half-shells 109c are joined together, sections 109e in
the respective half-shells adhere to each other, whereas a passage
for outlet branch 121b of needle 121 is defined between sections
109d.
[0068] In this second embodiment, insertion and release of the
needle take place as follows. When pushing cap 101a with sufficient
force towards container base 101c, projection 151 presses against
hose 111 and, by overcoming the resistance of pins 173 and the
elastic resistance of sleeve 101b, said projection forces
half-shells 109c apart. Sections 109d of said half-shells 109c
cannot be separated, since they are rigidly retained by L-shaped
projections of sleeve 101b, so that the passage for outlet branch
121b of needle 121 defined therebetween keeps unchanged. On the
contrary, sections 109e of said half-shells can be spaced apart, by
overcoming the elastic resistance of the edges of recess 165 in
sleeve 101b. In such manner, hose 111 can pass through half-shells
109c along slit 163, while needle 121 is guided between facing
sections 109d of half-shells 109c, until its outlet branch 121b
becomes completely placed through the patient's skin.
[0069] Similarly to what described in connection with the first
embodiment of the invention, also in this second embodiment the
container can comprise, outside housing 101 and against base 101c,
an adhesive gauze 5 weakly adhering to base 101c in correspondence
of a set of circular portions. Thus, gauze 5 can remain adhering to
the patient's skin after needle 121 has been placed through the
patient's skin and the container has been removed. Said adhesive
gauze 5 could be possibly joined with a second, protecting adhesive
gauze which could be folded onto said first gauze after container
removal.
[0070] It is clear that the above description has been given only
by way of non-limiting example and that changes and modifications
are possible without departing from the scope of the invention.
[0071] In particular, as already mentioned, even if the above
description has been given with reference to the insertion of a
needle through which the drug coming from a related hose is
delivered to a patient, the container according to the invention
can also be used for the insertion through a patient's skin of a
cannula provided with an insertion needle when the drug is to be
delivered to the patient directly through said cannula.
* * * * *