Method for connecting two objects using a polymer composition and a system, for use in a cosmetic procedure

Abstract

The invention is directed to a method for using a polymer composition for connecting a first object to a second object, wherein the method comprises, the step of applying a polymer composition to at least part of the surface of at least one of the first object or second object; connecting the first object and the second object at the surface where the polymer composition is applied and irradiating the polymer composition using UV-radiation over a first time period, obtaining a UV radiated polymer composition; irradiating the UV radiated polymer composition with gamma-radiation over a second time period obtaining a gamma radiated polymer. The invention also relates to a system of a plastic object and a metal object connected by the method of the invention. In addition, the invention relates to a cosmetic method for anti-aging skin treatment wherein the method comprises the steps of: subcutaneously administering of an effective amount a of a dermal filler or Botulinum toxin to an area of skin, preferably the face and/or neck area, wherein the administering is performed by a syringe and a hypodermic needle or cannula of the invention.

Claims

1. A method for using a polymer composition for connecting a first object to a second object, wherein the method comprises: applying a polymer composition to at least part of a surface of at least one of the first object or second object; connecting the first object and the second object at the surface where the polymer composition is applied and irradiating the polymer composition using UV-radiation over a first time period, obtaining a UV radiated polymer composition, wherein the first time period is sufficient to cure 10-90% of the polymer in the polymer composition; irradiating the UV radiated polymer composition with gamma-radiation over a second time period obtaining a gamma radiated polymer, wherein the second time period provides a gamma-radiation dosage of between 5 and 80 kGy, and wherein the gamma-radiation dosage corresponds to a sterility assurance level of at least 2 log reduction for micro-organisms for the first object and the second object.

2. Method according to claim 1 wherein the first object and second object comprise plastic or metal, wherein the first object is substantially in its entirety made of plastic or metal, wherein the first and second object are of a different material.

3. Method according to claim 1, wherein the first time period is sufficient to cure 20-80% of the polymer.

4. The method according to claim 1, wherein the polymer composition is curable under the influence of visible light or UV light, or both.

5. The method according to claim 1, wherein the polymer comprises at least one monomer selected from the group consisting of isobornyl acrylate, urethane acrylate, urethane methacrylate, acrylamide, and N,N-dimethylacrylamide.

6. The method according to claim 1, wherein the polymer composition is substantially free of bisphenol-A.

7. The method according to claim 1, wherein the first and second object comprise plastic, wherein the plastic is a copolyester and the plastic is permeable for UV and/or gamma radiation.

8. The method according to claim 1, wherein the first and second object comprise metal, wherein the metal is stainless steel.

9. The method according to claim 1, wherein one of the objects is plastic and one of the objects is metal and wherein the plastic object is a hub and the metal object is a needle or cannula.

Description

(1) In the drawings:

(2) FIG. 1 schematically shows a needle system during UV-irradiation;

(3) FIG. 2 schematically shows the curing progress over time for needle systems G21 and G27.

(4) In FIG. 1 a hypodermic needle 1 can be seen containing a needle 3, a needle-hub 5 joined by a UV-curable resin 7. The needle 3 is made out of stainless steel. The needle-hub 5 is made out of copolyester Tritan MX711. The resin 7 is DYMAX 1161-M as produced by DYMAX Europe GmbH, Frankfurt am main, Germany. This figure captures a moment during the UV-irradiation step 19 of the hypodermic needle 1. Here the hypodermic needle 1 is placed in an upright position with respect to the direction of gravity 17. As a result the interfaces 9, 11 of the resin with the hub 5 and needle 3 respectively are parallel to the direction of gravity 17. Prior to UV-irradiation the resin 7 was applied to area 13, where the resin 7 was able to spread in the direction of gravity along the outer surface of the needle 3 and along the inner surface of the hub. This extended the interfaces 9, 11 along the direction of spread. UV-irradiation occurs using a UV-source 14 overhead. The hypodermic needle 1 is thereby irradiated from a certain UV-irradiation direction 15.

(5) In FIG. 2 the curing progress of two hypodermic needles is given, one of a G21 and another of a G27 hypodermic needle. The diameter of the G27 type hypodermic needle is smaller than the diameter of the G21 type hypodermic needle. The curing progress is expressed as a percentage of pulling force which any of the needles G21 and G27 can resist at any of the respective is able to resist at a given moment in time. It can be seen from FIG. 2 that needles of a diameter differing to another can be fully cured simultaneously in the same process.

(6) It is thus believed that the operation and construction of the present invention will be apparent from the foregoing description and drawings appended thereto. For the purpose of clarity and a concise description features are described herein as part of the same or separate embodiments, however, it will be appreciated that the scope of the invention may include embodiments having combinations of all or some of the features described. It will be clear to the skilled person that the invention is not limited to any embodiment herein described and that modifications are possible which may be considered within the scope of the appended claims. Also kinematic inversions are considered inherently disclosed and can be within the scope of the invention. In the claims, any reference signs shall not be construed as limiting the claim. The terms ‘comprising’ and ‘including’ when used in this description or the appended claims should not be construed in an exclusive or exhaustive sense but rather in an inclusive sense. Thus expression as ‘including’ or ‘comprising’ as used herein does not exclude the presence of other elements, additional structure or additional acts or steps in addition to those listed. Furthermore, the words ‘a’ and ‘an’ shall not be construed as limited to ‘only one’, but instead are used to mean ‘at least one’, and do not exclude a plurality. Features that are not specifically or explicitly described or claimed may additionally be included in the structure of the invention without departing from its scope. Expressions such as: “means for . . . ” should be read as: “component configured for . . . ” or “member constructed to . . . ” and should be construed to include equivalents for the structures disclosed. The use of expressions like: “critical”, “preferred”, “especially preferred” etc. is not intended to limit the invention. To the extend that structure, material, or acts are considered to be essential they are inexpressively indicated as such. Additions, deletions, and modifications within the purview of the skilled person may generally be made without departing from the scope of the invention, as determined by the claims.

EXAMPLES

(7) A pull out test is performed to compare bonding strength of polymer for metal needle and plastic hub.

(8) Glue is DYMAX 1161-M;

(9) UV irradiator: Blue wave LED Prime UVA spot-Curing system and φ3 liquid light guide, 4 branched (2 out of 4 were used) 1.5 m. UV curing time is 2 seconds or as indicated, from both sides at an angle of 45° at 2 mm distance.

(10) Needle size is as indicated.

(11) Hubs used: A8 hub Tritan resin MX711 and Hypodermic Hub from polypropylene resin (PP).

(12) Pull out test is performed after UV curing and with and without additional radiation with gamma radiation (25-50 kGy).

(13) The pull out test measures the force (N) needed to pull out the needle from the hub. The force is applied as push or pull in the direction of the needle axis. The following criteria are used: at a power of 22 N the needle must not be pulled out (ISO 7864 1993). Only 1 bubble is allowed in the glue and the bubble cannot be larger than 0.05 mm.sup.2. For each test 20 needles were tested.

Example 1

(14) UV curing was performed for 1, 1.2, and 1.4 seconds with a 27 G needle, A8 Hub Tritan MX711 and DYMAX 1161-M.

(15) TABLE-US-00002 TABLE 2 Results 1 s UV 1 s UV 1.2 s UV 1.2 s UV 1.4 s UV 1.4 s UV no with no with no with gamma gamma gamma gamma gamma gamma MAX 90.5 89.5 88.0 87.0 87.0 88.5 MIN 69.5 79.0 67.5 79.5 74.5 74.0 aver- 78.43 84.95 81.75 83.28 81.78 81.78 age σ 5.56 2.87 4.28 2.46 3.11 3.87

(16) As can be seen for 1 and 1.2 seconds curing, the gamma radiation significantly increases the strength of the bond between hub and needle. This enable a shorter UV radiation time.

Example 2

(17) The test was repeated for 21 G and 27 G needles. Hub was A8 Tritan MX711, 20 needles before gamma radiation and 20 needles after gamma radiation were used. UV radiation 2 seconds, Gamma radiation 25-50 kGy. Polymer was DYMAX 1161-M.

(18) TABLE-US-00003 21 G no 21 G with 27 G no 27 G with gamma gamma gamma gamma MAX 191.5 245.0 92.0 90.5 MIN 113.0 160.5 81.5 76.5 average 160.68 206.83 86.03 84.13 σ 24.39 25.02 2.49 3.51

(19) As can be seen, for larger needles, the effect is present also at 2 second of UV radiation.

Example 3

Acceleration Test

(20) Acceleration conditions: needles were kept at 54° C. at 75% humidity for 29 days. Needles 21 G, 27 G, 30 G, 32 G. Hub was made of Tritan MX711, adhesive was DYMAX 1161-M. UV radiation was 2 seconds. Gamma radiation was 50 kGy.

(21) TABLE-US-00004 21 G 21 G 21 G with 27 G 27 G 27 G with no with gamma and no with gamma and gamma gamma acceleration gamma gamma acceleration MAX 179.5 247.0 243.5 85.5 90.5 91.5 MIN 77.0 211.0 204.5 66.0 78.5 79.0 aver- 108.38 228.10 225.13 77.50 85.08 85.30 age σ 26.57 9.18 8.91 6.09 2.74 3.03 30 G 30 G 30 G with 32 G 32 G 32 G with no with gamma and no with gamma and gamma gamma acceleration gamma gamma acceleration MAX 68.5 71.5 73.0 54.0 57.5 58.5 MIN 52.0 54.5 56.0 39.5 50.0 50.0 aver- 61.25 66.2 66.88 48.90 53.93 53.90 age σ 4.16 3.79 4.49 3.59 2.38 2.35

(22) As can be seen after gamma radiation, the bonding of the hub and needle is stronger than before gamma radiation, especially for larger needles. The method of combining UV radiation and gamma radiation does not deteriorate over time as the acceleration method shows.

Example 4

(23) Test was repeated with DYMAX1193-M-SV04 and Henkel 3301 as adhesive and 27 G needle A7 hub Zeonex 690R:

(24) TABLE-US-00005 DYMAX1193- DYMAX1193- DYMAX1193- Henkel Henkel Henkel M-SV04 M-SV04 M-SV04 with 3301 3301 3301 with no with gamma and no with gamma and gamma gamma acceleration gamma gamma acceleration MAX 92.5 93.5 89.0 92.5 93.5 85.0 MIN 42.0 65.0 47.0 38.0 47.0 22.0 average 77.0 84.3 66.6 77.4 76.4 50.4