NZ626278B2 - Bruiseless cannula - Google Patents
Bruiseless cannula Download PDFInfo
- Publication number
- NZ626278B2 NZ626278B2 NZ626278A NZ62627812A NZ626278B2 NZ 626278 B2 NZ626278 B2 NZ 626278B2 NZ 626278 A NZ626278 A NZ 626278A NZ 62627812 A NZ62627812 A NZ 62627812A NZ 626278 B2 NZ626278 B2 NZ 626278B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- housing
- cannula
- proximal end
- needle device
- housing element
- Prior art date
Links
- 238000002347 injection Methods 0.000 claims abstract description 61
- 239000007924 injection Substances 0.000 claims abstract description 61
- 239000000203 mixture Substances 0.000 claims description 29
- 239000007788 liquid Substances 0.000 claims description 26
- 239000002537 cosmetic Substances 0.000 claims description 9
- 208000034656 Contusions Diseases 0.000 abstract description 16
- 208000014674 injury Diseases 0.000 abstract description 9
- 230000008733 trauma Effects 0.000 abstract description 9
- 238000010276 construction Methods 0.000 abstract 2
- 210000003491 skin Anatomy 0.000 description 44
- 239000000499 gel Substances 0.000 description 29
- 210000002615 epidermis Anatomy 0.000 description 22
- 210000001519 tissue Anatomy 0.000 description 22
- 150000002500 ions Chemical class 0.000 description 11
- 238000000034 method Methods 0.000 description 9
- 210000004204 blood vessel Anatomy 0.000 description 7
- 210000004207 dermis Anatomy 0.000 description 7
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 description 6
- 229920002674 hyaluronan Polymers 0.000 description 6
- 229960003160 hyaluronic acid Drugs 0.000 description 6
- 230000002500 effect on skin Effects 0.000 description 3
- 239000000945 filler Substances 0.000 description 3
- 230000000149 penetrating effect Effects 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 241001631457 Cannula Species 0.000 description 2
- 230000002349 favourable effect Effects 0.000 description 2
- 206010033675 panniculitis Diseases 0.000 description 2
- 230000037368 penetrate the skin Effects 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- 229920001432 poly(L-lactide) Polymers 0.000 description 2
- 229920003229 poly(methyl methacrylate) Polymers 0.000 description 2
- 239000004926 polymethyl methacrylate Substances 0.000 description 2
- OGNVQLDIPUXYDH-ZPKKHLQPSA-N (2R,3R,4S)-3-(2-methylpropanoylamino)-4-(4-phenyltriazol-1-yl)-2-[(1R,2R)-1,2,3-trihydroxypropyl]-3,4-dihydro-2H-pyran-6-carboxylic acid Chemical compound CC(C)C(=O)N[C@H]1[C@H]([C@H](O)[C@H](O)CO)OC(C(O)=O)=C[C@@H]1N1N=NC(C=2C=CC=CC=2)=C1 OGNVQLDIPUXYDH-ZPKKHLQPSA-N 0.000 description 1
- 108030001720 Bontoxilysin Proteins 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- 229920001605 Dextranomer Polymers 0.000 description 1
- 208000012659 Joint disease Diseases 0.000 description 1
- JVTAAEKCZFNVCJ-REOHCLBHSA-N L-lactic acid Chemical compound C[C@H](O)C(O)=O JVTAAEKCZFNVCJ-REOHCLBHSA-N 0.000 description 1
- 229920001954 Restylane Polymers 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 230000003466 anti-cipated effect Effects 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 239000011324 bead Substances 0.000 description 1
- 239000012867 bioactive agent Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229940053031 botulinum toxin Drugs 0.000 description 1
- 229940110716 cicatrizants Drugs 0.000 description 1
- -1 cicatrizants Substances 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 238000002316 cosmetic surgery Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 229960002864 dextranomer Drugs 0.000 description 1
- 238000009792 diffusion process Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000005530 etching Methods 0.000 description 1
- 210000000744 eyelid Anatomy 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 239000000017 hydrogel Substances 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 239000003589 local anesthetic agent Substances 0.000 description 1
- 229960005015 local anesthetics Drugs 0.000 description 1
- 238000001053 micromoulding Methods 0.000 description 1
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 1
- 229920002401 polyacrylamide Polymers 0.000 description 1
- 229920001610 polycaprolactone Polymers 0.000 description 1
- 239000004632 polycaprolactone Substances 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 231100000241 scar Toxicity 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
- 238000004513 sizing Methods 0.000 description 1
- 229910000811 surgical stainless steel Inorganic materials 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
- A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
- A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3286—Needle tip design, e.g. for improved penetration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
- A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
Abstract
needle device (6) comprising a housing which can be mounted to an injection device (1) is disclosed. The housing comprises a first housing element (13) provided towards a proximal end of the needle device (6) and a second housing element (15) provided towards a distal end of the needle device (6). A cutting element (14) having a sharp proximal end is arranged at a proximal end of the first housing element (13). A cannula having a blunt proximal end (11) is fitted to the second housing element (15) and an opening for the cannula (11) is provided at the proximal end of the first housing element (13). The first housing element (13) and the second housing (15) element are moveable relative to each other between an extended position where the proximal end of the cannula (11) does not extend beyond the proximal end of the cutting element (14) and a compressed position where the cannula (11) extends through the opening of the first housing element (13) and past the proximal end of the cutting element (14). This construction greatly reduces the risk of post-treatment bruising and tissue trauma. A cutting element (14) having a sharp proximal end is arranged at a proximal end of the first housing element (13). A cannula having a blunt proximal end (11) is fitted to the second housing element (15) and an opening for the cannula (11) is provided at the proximal end of the first housing element (13). The first housing element (13) and the second housing (15) element are moveable relative to each other between an extended position where the proximal end of the cannula (11) does not extend beyond the proximal end of the cutting element (14) and a compressed position where the cannula (11) extends through the opening of the first housing element (13) and past the proximal end of the cutting element (14). This construction greatly reduces the risk of post-treatment bruising and tissue trauma.
Description
BRUISELESS CANNULA
FIELD OF THE INVENTION
The present invention relates to a needle device for an injection
tus for delivering liquid or gel compositions, such as viscous gels of
e.g. hyaluronic acid. It also relates to an ion apparatus using such
needle device, the use of such needle device or ion apparatus and a
method for administration of a liquid or gel composition.
BACKGROUND OF THE INVENTION
In certain fields of application, large numbers of injections have to be
made within a region of skin of a patient. One example of such field of
ation is cosmetic treatment where e.g. dermal fillers in the form of gels
of hyaluronic acid are ed into the tissue of a t in order to fill out
undesirable wrinkles and similar. In the prior art, ion is typically done by
using a syringe fitted with a hypodermic needle having a sharp, beveled tip.
One challenge during such injection is to avoid bruising of the skin tissue or
tissue trauma. This is especially relevant when visible skin regions such as
the face, hands or décolletage of a patient is treated. Another drawback with
the use of a traditional syringe in that type of treatment is that it can be time
consuming considering the large number of injections sometimes required. In
another prior art method, a number of incisions are made over a surface to be
treated with a first instrument, e.g. a scalpel or a sharp hypodermic needle.
Then, in a following stage, a blunt cannula is introduced h these
openings and a liquid or gel composition is injected. That prior art method
does however e a number of drawbacks. It is inexpedient and
inconvenient to have to use two different instruments during the work and if a
large number of injections are necessary, that method is very time
consuming. Further, the risk of cutting too deep in the first stage is rather high
which increases the risk of post-treatment bruising and tissue trauma.
Another non-negligible disadvantage with that method is the fact that it can be
quite hard to find the insicions when the blunt cannula is to be inserted since
the opening is rather small. Prior art document US 5098389 discloses a
needle assembly having a handle with a short introduce needle mounted to
the handle, and a blunt cannula mounted within the handle and slidable within
the handle. The needle assembly is held at the handle with one hand, and
pushed against the skin. The introducer needle thereby cuts an incision.
Then the cannula is inserted with the other hand. Such a two-hand operation
is rable. Additionally, the needle ly is not ucted for
multiple injections. Prior art nt US 3840008 ses a needle
having a pointed hollow piercing member slidably mounted about a blunt
cannula. The piercing member has a callopsible bar, which is finger
operated. After having introduced the piercing member while holding the
finger on the bar, the user removes the finger and inserts the cannula. During
the last ned part of the operation the bar ses. The needle is
difficult to use and is not ucted for multiple injections. Another example
is disclosed in GB 624269, where an injection needle has an outer sharp
needle and an inner blunt cannula. The injection needle is a typical single
injection device.
SUMMARY OF THE INVENTION
It is an object of the t invention to reduce or eliminate the above
mentioned and other drawbacks. Alternatively, it is an object of the invention
to at least provide the public with a useful choice. At least one of these
objects or another object is achieved by a needle device according to the
present invention as defined in claim 1 of the appended claims, or by an
injection apparatus as defined in claim 9. Preferred embodiments of the
present invention are defined in the dependent claims.
Thus, in accordance with a first aspect of the present invention there is
provided a needle device for an injection apparatus, n said needle
device comprises a housing which can be mounted to an injection device,
said housing sing a first housing element provided towards a proximal
end of said needle device and a second housing element provided towards a
distal end of said needle . A cutting element having a sharp proximal
end is arranged at a proximal end of said first housing element. A cannula
having a blunt proximal end is fitted to the second housing element and an
opening for said cannula is provided at the al end of the first housing
element. The first housing element and the second housing element are
moveable relative to each other between an extended position and a
ssed position where the proximal end of the cannula does not extend
beyond the proximal end of the g element when the first and second
housing elements are in the extended position and wherein the cannula
extends through the opening of the first housing element and past the
1O al end of the cutting element when the first and second housing
elements are in the compressed position. This arrangement entails a number
of advantages, the avoiding of bruising of the skin being one. Since the
cutting element only is required for the initial creating of an opening in the skin
and not for the injection itself, it’s length can be reduced to only reach through
the uppermost layer of the skin, the epidermis. In comparison with other skin
layers, such as the dermis, the epidermis is rather tough and leathery and
forms the outermost layer of the skin acting as a waterproof protective wrap
over the body. The thickness of the epidermis varies over different s of
the body, between imately 0,05mm on the eyelids to approximately
1,5mm on the palms and soles. The epidermis ns no blood vessels but
is instead nourished by diffusion from blood capillaries ing to the upper
layers of the underlying dermis. The absence of blood vessels in the
epidermis means that bruising of the skin does not occur in this layer but
rather in subjacent skin layers containing blood vessels. As soon as an
opening is created in the epidermis the continued penetration into deeper skin
layers is done with the blunt cannula while the cutting element remains in the
epidermis penetrating position. The blunt cannula can ate through the
underlying dermis and subcutis without performing any cutting of the tissue.
Instead, the tissue is pushed aside as the blunt cannula penetrates it and the
blood vessels can remain intact. As soon as the blunt cannula has reached
the anticipated depth, ion of the liquid or gel composition can be
med. This oration n the cutting element and the blunt
cannula ensures an easily worked device with which skin bruising and tissue
trauma can be substantially avoided.
rmore, a resilient member is provided within the housing and
ed to bias the first housing element and the second housing element
towards the ed position. The biasing force of the spring can be chosen
to substantially correspond to the force necessary for the cutting element to
penetrate the epidermis. A user then only has to force the needle device
against a desirable skin region and the cutting element will penetrate the skin
and the cannula will penetrate deeper to the desirable depth in one
uous motion.
In accordance with an embodiment of the injection device of the
invention, the second housing element ses an adaptor arranged to
mount the needle device to an injection device and wherein said cannula is
fitted to said adaptor and said adaptor being adjustably mounted to the
second housing element such that it is possible to adjust how far beyond the
proximal end of the cutting element the cannula extends when the first and
the second housing elements are in the compressed position. By adjusting
the relative position between the r, and thus the cannula, and the
second housing element, it is le to adjust how deep the cannula
penetrates into the tissue.
In accordance with an embodiment of the injection device of the
invention, the adaptor is mounted to the second housing element by a
threaded connection. A ed connection provides for a simple, reliable
and finely adjustable connection.
In accordance with an ment of the injection device of the
invention, the cutting t comprises a beveled needle provided with a
sharp tip, wherein the cannula and the beveled needle are coaxially mounted
such that the cannula extends through the interior of the beveled needle when
the first housing element is in the compressed on. The use of a beveled
needle provides for a simple and cost effective on. The beveled needle
is d within the opening of the first g element such that the blunt
cannula can pass through its opening.
In accordance with an embodiment of the injection device of the
invention, the cutting element s partly around a perimeter of the
opening in the first housing element. By providing the cutting element
adjacent the opening of the first housing element but extending only around a
part of the perimeter of said opening, the problem of coring can be avoided.
Coring is a designation of the hole cutout of the skin that may occur when a
hollow needle is used as a cutting element. This is highly undesirable as it will
have a ve impact in appearance. If coring occurs, there is a risk that the
cut out skin piece will be pushed into and left within the skin of the patient. By
using a cutting element which extends only partly around a perimeter of the
opening, an opening can be created which is more or less c—shaped, or even
l-shaped, which is more favorable. Generally, the smaller the opening in the
skin, the better since this will favour the healing process and lessens the risk
of bruising and other post-treatment problems. However, the opening of
course has to be large enough to allow the blunt cannula to enter.
In accordance with an embodiment of the injection device of the
invention, the cutting element comprises a micro needle. Micro needles can
for example be produced by silicon etching or micro molding and can be
made extremely sharp producing a very clean incision which is favourable
from a g point of view.
In accordance with an embodiment of the injection device of the
invention, the a having a blunt al end comprises a lateral orifice
through which a liquid or gel composition can be red. The needle can
be made of ed surgical steel and the lateral opening has a smooth
design to avoid damage to the tissue while allowing the liquid or gel
composition to flow easily through and out of the cannula.
In accordance with an embodiment of the injection device of the
invention, the g element has a length between 0,05mm to 1,5mm. By
using a cutting element with a length specifically adapted to the thickness of
the mis of the designated skin area, the risk of skin bruising or tissue
trauma can be even further reduced.
In accordance with a second aspect of the ion, an ion
apparatus is provided comprising an injector and a needle device according
to any of the preceding claims 1-9.
In accordance with an embodiment of the injection apparatus of the
invention, the injector comprises a container filled with a liquid or gel
composition for cosmetic treatment.
There is further provided use of a needle device according to any one
of claims 1-9 or an injection apparatus according to claim 10 or 11 for
ng bruising during percutaneous administration of a liquid or gel
composition.
In accordance with the use of a needle device, the liquid or gel
composition may be for cosmetic treatment.
A method for percutaneous administration of a liquid or gel composition
is disclosed, said method sing the following steps:
- penetrating the mis at a desirable skin reg ion by pressing a
cutting element having a sharp proximal end against the skin to create
an opening in the epidermis;
- ing a cannula having a blunt proximal end t hrough the opening
created in the epidermis by moving the cannula relative to the cutting
element, while maintaining the g element in an epidermispenetrating
position;
- wherein the proximal end of the cannula is insert ed to a greater depth
in the skin than the proximal end of the cutting element; and
- administrating the liquid or gel composition thro ugh the cannula.
The liquid or gel composition may be for cosmetic treatment.
For implementing the method for percutaneous administration of a
liquid or gel composition of the ion, a needle device according to the
first aspect or an injection apparatus according to the second aspect may
be used.
Further objects and advantages of the present invention will be
discussed below by means of ifying embodiments. These and other
features, aspects and advantages of the invention will be more fully
understood when considered with respect to the following detailed
description, appended claims and anying drawings.
Unless the context clearly requires otherwise, throughout the ption and
claims the terms “comprise”, “comprising” and the like are to be construed in
an inclusive sense, as opposed to an exclusive or tive sense. That is,
in the sense of “including, but not limited to”.
BRIEF PTION OF THE DRAWINGS
The invention will now be described in more detail and with reference to
the appended drawings in which:
Fig. 1 is an exploded schematic perspective view of a first embodiment of
the injection apparatus according to the invention.
Fig. 2 is a schematic ctive view of a first embodiment of the
injection apparatus according to the invention.
Figs. 3a-3c show schematic cross-sectional side views of different stages
of operation of an injection apparatus according to the invention.
Fig. 4 shows a schematic cross-sectional side view of a second
embodiment of the injection apparatus according to the invention.
Fig. 5 shows a schematic sectional side view of a third embodiment
of the injection apparatus according to the ion as well as an
ement of the proximal end f.
DESCRIPTION OF PREFERRED EMBODIMENTS
In this description as well as the claims, a proximal end, or similar, is to be
understood as the part of a component which, when the needle device or
injection apparatus is in use, will be closer to the injection site, i.e. the skin of
a patient. A distal end, or similar, on the other hand, should be understood as
the part of a component which, when the needle device or injection apparatus
is in use, will be further away from the injection site.
A first embodiment of the ion apparatus 100 according to the
invention is shown in figures 1 and 2 where figure 1 shows an exploded view
where each separate component and its on relative to the other
components can be seen and figure 2 shows the injection apparatus 100 in
an assembled state. The injection apparatus 100 comprises an injector in the
form of a syringe 1 comprising a barrel 2, a plunger rod 3, a plunger 4 and a
locking device 5. In this embodiment the locking device comprises a male
Luer Lock connection fitting. Of course, many other locking devices are
conceivable, such as Luer or other press-fit connections, threaded
connections and others, all obvious to the skilled person. d to the
injector 1 is a needle device 6. The needle device 6 in its turn comprises an
adaptor 7 having a female Luer Lock connection fitting 8 which fits into the
male fitting 5 of the syringe 1 such that the syringe 1 and the needle device 6
can be connected to each other. The r 7 further comprises an adjusting
collar 9, the function of which will be described later on, and a threaded part
. A cannula 11 having a blunt proximal end is fitted to the adaptor 7. The
cannula 11 comprises a lateral orifice, not shown in the figures, near the blunt
end thereof through which orifice a liquid or gel composition can be expelled.
The l orifice has a smooth design which avoids damage to the tissue
and allows the liquid or gel composition to flow easily through and out of the
a. A second housing element 15 is connected to the adaptor 7 by
means of an al thread at a distal end of said second housing element 15
and an external thread 10 provided at a proximal end of the adaptor 7. An
adjusting collar 16 is provided on the second housing element 15 with which
the adjustment of the relative position between the second housing element
and the r 7 is simplified. Fitted within said second housing t
is a first housing element 13 and the first and the second housing
elements 13, 15 are moveable relative to each other between a compressed
and an ed position, this will be described thoroughly with respect to
s 3a—3b. A resilient member in the form of a spring 12 is provided
between the adaptor 7 and the first housing element 13 biasing the housing
elements 13, 15 towards their extended position. A cutting element 14 is
ed at a proximal end of the first housing element.
Referring now to figures 3a—3b as well as to previously described figures 1
and 2, the oning of an injection apparatus 100 when used for e.g.
cosmetic treatment will be described. A user, such as a doctor, a nurse or any
other person capable of performing the ic treatment positions the
injection apparatus 100 near a skin region 200 to be treated. Then the user,
holding the injector 1, penetrates the upper skin layer, the epidermis, of the
skin region to be d 200 by g the cutting element 14 towards the
skin. The cutting element 14 is disclosed in this embodiment in the form of a
beveled needle mounted within the proximal opening in the first housing
element 13. Another solution for the cutting element 14 will described later on
with reference to figure 5. The axial position of the beveled needle within the
first housing element 13 will vary depending on the intended g depth. It
is also possible to reduce the risk of coring by arranging the beveled needle
at such a position in the opening of the first housing t 13 that a part of
the cutting edge of the beveled needle is hidden within the opening in the first
housing element 13. The actual cutting edge of the cutting element 14 will
then only extend around a part of the perimeter of the opening in the first
housing element 13, thus reducing the risk for coring of skin tissue to occur.
Spring 12 has a spring rate stiff enough to ensure that the cutting element 14
creates an opening in the skin before the spring yields. This first stage can be
seen in figure 3a. As the user continues to push, see figure 3b, the spring will
yield and the first and second housing elements 13, 15 will start to move
relative to each other towards a compressed position. As this takes place,
cannula 11 will move relative to g element 14 and eventually the
cannula 11 will extend beyond g element 14 and penetrate deeper into
the skin of the patient. This relative movement occurs since the cannula 11 is
fixedly mounted to the adaptor 7 which in turn is mounted to the second
housing 15. A continued g of the user will move the syringe 1, adaptor
7, cannula 11 and second housing element 15 closer to the skin region 200 of
the patient while first g element 13 and cutting element 14 remains
stationary relative to the skin region 200. When the position shown in figure
is d, no r relative movement between the first and second
housing element can take place. This since a proximal end of the second
housing element 15 has reached the surface of skin region 200. At this point,
cannula 11 has reached its injection depth and the user manipulates the
injector in order to expel a suitable amount of liquid or gel composition into
the tissue surrounding the cannula 11. The spring rate of the helical spring 12
is preferably chosen to be stiff enough such that the cutting element 14 can
penetrate the skin of the patient without any relative movement between the
first and the second housing element taking place. It should however not be
so stiff that an unnecessary high force has to be used in order to initiate the
relative movement between the first and second housing element and y
the introduction of the cannula 11 into the tissue of the patient. This since an
unnecessary high spring rate can be uncomfortable for the patient. The force
ary to penetrate the epidermis of the skin with the cutting t 14
depends on the size and the shape of the cutting element and can vary from
a few tenths of a Newton when using a very small and sharp micro needle as
g element 14 up to 2-4 Newton when a beveled needle is used as
cutting element 14. The spring rate of the helical spring 12 should therefore
be chosen considering the properties of the cutting element 14 and probably
also the properties of the skin region 200 to be treated since the properties of
different skin regions differs from each other. The spring rate of the spring 12
should be chosen such that at least the force necessary to penetrate the
epidermis is ed to compress the spring to avoid that the blunt cannula
11 s beyond the cutting element 14 at a too early stage. That would
result in the blunt end of the cannula taking the lead during penetration of the
epidermis which can be perceived as a discomfort to the patient since a
rather high force will be necessary.
The main advantage with the injection apparatus according to the present
invention is that bruising of the skin and tissue trauma can be avoided. This is
due to the collaboration between the sharp cutting element 14 and the blunt
cannula. The cutting element 14 is designed to cut through the tissue
epidermis but not into the subjacent dermis. Since the mis does not
contain any blood vessels and the cutting element does not reach below the
epidermis, bruising is very unlikely to occur due to the cutting element. The
length of the cutting element 14 should be chosen such that the cutting
element 14 creates an opening h the epidermis but does not penetrate
into the subjacent dermis in order to avoid rupturing of blood vessels therein.
Of course, it would also be le to provide a needle device 6 having an
adjustable cutting element 14. Alternatively, needle devices 6 having cutting
elements with different lengths can be provided for ent skin regions. In a
following step, when an g in the epidermis has been created, the blunt
cannula is inserted into the dermis, and possibly also into the hypodermis, or
subcutis, where the liquid or gel composition is injected. Examples of
compositions that can by injected with the injection apparatus of the present
invention is gels of hyaluronic acid, such as ane Vital TM or Restylane
Vital Light TM. The blunt cannula does not perform any cutting action as it
penetrates the tissue. Instead, the tissue of the layers h the epidermis
is pushed aside by the blunt al end of the cannula 11 and the blood
vessels can remain intact thus preventing bruising and tissue trauma. The
final depth of the cannula 11 can be adjusted by means of the threaded
3O connection 10 between the adaptor 7 and the second housing element 15,
the adjusting collars 9, 16 are convenient to use for this purpose. The r
into the second housing t 15 the adaptor 7 is screwed, the deeper the
cannula 11 will reach into the tissue of the patient. With the needle device 6 of
the present invention, it is thus possible to finely adjust the depth where
injection takes place. And since the injection apparatus of the present
ion will come to a stop when the proximal surface of the second
housing t 15 s the skin of the patient, it is very easy for a user
to edly perform injection at exactly the same depth. All that has to be
done is pushing the injector 1 with the needle device 6 against the skin of the
patient until the second g element 15 reaches the skin of the t
and thereafter actuate the injector in order to inject a suitable amount of liquid
or gel composition. The handling will be even easier for a user if the injector
1O comprises an automatic or semi-automatic injector, for example electronic
injectors or spring loaded injectors, which are capable of expelling any
desired amount of liquid or gel composition with a high accuracy and
repeatability. r advantage with the present invention is the fact that a
user does not have to keep track of the location of the opening in the dermis.
In prior art injection s, where the g in the skin is created in a
first stage using a first instrument which is then put aside and the blunt
cannula is inserted in a second stage it can sometimes actually be hard to
retrieve the opening again. With the present invention, the creation of the
opening and the insertion of the blunt cannula into the tissue takes place in
one continuous motion and since the cutting element 14 remains in its
epidermis penetrating position and acts as a guiding element for the blunt
cannula 11 towards the opening created by the cutting element 14. When it
comes to the diameters of the g element 14 and the cannula 11, these
varies with the intended use. Concerning the cannula 11, common sizes are
21G-30G. Since the cutting element in the embodiment described in figures
1-4 ses a d needle through which the cannula shall pass, the
size of the needle has to be chosen to allow this. This would correspond to
needle sizes of 18G-23G for regular—wall needles. For needles having thicker
or thinner walls, the sizing is adapted correspondingly. However, cannulas
and needles of other sizes are also possible, for example 31G and 32G
cannulas are very well imaginable for the needle device according to the
present invention.
The needle device of the present invention is especially convenient when
performing cosmetic treatment of e.g. the face where ng is particularly
inconvenient. Cosmetic treatment such as skin boosting requires regular
treatment, typically at three occasions initially with one week between each
treatment. Thereafter, re-treatment is necessary once or twice every year.
The traditional method using a hypodermic needle will probably not cause
post-treatment bruising at each injection site but since each treatment
includes a high number of injections, it is very likely that bruising will occur to
some extent. With the present invention on the other hand, bruising and
tissue trauma can be avoided.
Figure 4 shows in a schematic way an alternative embodiment of the
needle device of the present invention. In this ment, the adaptor has
been d and the second housing element 15 of the needle device 6 is
mounted directly to the locking device 5. This means that the length with
which the cannula 11 s beyond the cutting element 14 cannot be
adjusted but for most ations a fixed length will be sufficient. In order to
assemble the needle device of this embodiment, the second housing element
could be made to comprise two hells which are interconnectable.
Other assembly solutions are also conceivable to the skilled .
Figure 5 shows in a tic way a second alternative embodiment of
the needle device of the present invention. In this embodiment, the cutting
element 14 does not comprise a beveled needle. Instead, a jag is arranged
near the g in the first housing element. This is perfectly sufficient to
create an g in epidermis and if the jag is made up from a micro needle
it can be made extremely sharp resulting in fine incisions which heal good,
leaving no or at least almost no scar tissue. The sharpness of such jags
further reduces the force necessary to penetrate epidermis which facilitate
handling and reduces discomfort of the patient.
Finally, it is realized, that even though ors in the form of traditional
syringes have been disclosed in this application it should be noted that a
many other types of injectors could be used without deviating from the scope
of the ation as defined by the appended claims. For example syringes
for use with exchangeable cartridges containing liquid or gel compositions
could be used. Further, re—chargeable electronic injectors for use with
exchangeable cartridges containing liquid or gel compositions would also be
suitable as well as injectors having other means than batteries for
accumulating energy such as d springs or pneumatic injectors.
Further, instead of using a helical spring as a resilient element within the
housing, many ative solutions are possible as well, such as elastomeric
elements or air springs. The injection of crosslinked or non-crosslinked
hyaluronic acid gels has been mentioned as a possible area of use for the
device according to the invention. The hyaluronic acid gel is useful as a
medical device, e.g. a dermal filler, for cosmetic use. It may also be useful in
medical surgery, e.g. in eye surgery, joint surgery and medical cosmetic
surgery or as a medicament, e.g. for ent of joint disease. Naturally, it is
possible to use the device ing to the present invention with other liquid
compositions, and preferably gel compositions, such as hydrogels. The
device is also useful for injecting other types of dermal fillers than onic
acid, e.g. collagen, calcium hydroxyl apatite, poly-L-lactic acid (PLLA),
polymethylmethacrylate (PMMA), polycaprolactone and polyacrylamide.
Furthermore, the device is useful for injecting liquid compositions comprising
active nces, e.g. bioactive agents, local anesthetics, cicatrizants,
antioxidants or botulinum toxin. A red liquid composition of this type is a
gel composition with a hyaluronic acid gel carrier and an active substance,
e.g. a local etic or a cictrizant, such as dextranomer beads.
Claims (12)
1) Needle device for an injection apparatus, wherein said needle device comprises: 5 - a housing which can be mounted to an injection de vice, said housing comprising a first housing element provided s a proximal end of said needle device and a second housing element (15) provided towards a distal end of said needle device; - a cutting element ed at a proximal end of s aid first housing 10 element, said cutting element having a sharp al end; - a a fitted to the second housing element, s aid cannula having a blunt proximal end; and - an opening for said cannula provided at the proxi mal end of the first housing t; 15 wherein the first housing element and the second g element are moveable relative to each other between an extended position and a compressed position; wherein the proximal end of the cannula does not extend beyond the proximal end of the cutting t when the first and second housing elements are in the extended 20 position and wherein the cannula extends through the opening of the first housing element and past the proximal end of the cutting element when the first and second housing element are in the compressed position, wherein: 25 the first housing element is fitted within the second housing element, and a resilient member is provided within the housing and arranged to bias the first housing element and the second housing element s the extended position.
2) Needle device for an injection apparatus according to claim 1, 30 wherein the second housing element comprises an adaptor arranged to mount the needle device to an injection device and wherein said cannula is fitted to said adaptor and said adaptor being ably mounted to the second g element such that it is possible to te how far beyond the proximal end of the cutting element the cannula extends when the first housing element and second housing element is in the compressed position.
3) Needle device for an injection apparatus according to claim 2, 5 wherein the adaptor is d to the second housing t by a threaded connection.
4) Needle device for an injection apparatus according to any of claims 1 to 3, wherein the cutting element comprises a d needle provided with a sharp tip, wherein the cannula and the beveled 10 needle are coaxially mounted such that the cannula extends through the interior of the beveled needle when the first housing element and the second housing element is in the compressed position.
5) Needle device for an injection apparatus according to any one of the ing claims, n the cutting element extends partly around 15 a perimeter of the opening in the first g element.
6) Needle device for an injection apparatus according to any one of the preceding claims, wherein the cutting element comprises a micro
7) Needle device for an injection apparatus according to any one of the 20 preceding claims, wherein the cannula having a blunt proximal end comprises a lateral orifice through which a liquid composition can be delivered.
8) Needle device for an injection apparatus according to any one of the preceding claims, wherein the cutting t has a length between 25 0,05mm to 1,5mm.
9) Injection apparatus comprising an injector and a needle device according to any one of the preceding claims 1 to 8.
10) ion apparatus according to claim 9, wherein the injector comprises a ner filled with a liquid or gel composition for 30 cosmetic treatment.
11) A needle device for an injection apparatus substantially as herein described with reference to any one of the embodiments illustrated in the accompanying drawings.
12) An ion apparatus substantially as herein described with reference to any one of the embodiments illustrated in the accompanying drawings. WO 98166
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP11196145.4 | 2011-12-30 | ||
| EP11196145.4A EP2609952B1 (en) | 2011-12-30 | 2011-12-30 | Bruiseless cannula |
| PCT/EP2012/076200 WO2013098166A1 (en) | 2011-12-30 | 2012-12-19 | Bruiseless cannula |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| NZ626278A NZ626278A (en) | 2015-10-30 |
| NZ626278B2 true NZ626278B2 (en) | 2016-02-02 |
Family
ID=
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