COATED HAIR AND USES THEREOF

Abstract

The present invention relates to implantable hair which is characterized in that it is coated at least in an implantable section with a composition that comes into direct or indirect contact with the hair and contains at least one silk protein. The present invention is further concerned with methods of producing such an implantable hair and the cosmetic use thereof.

Claims

1-25. (canceled)

26. An implantable hair comprising at least one implantable section, wherein the at least one implantable section is coated with a composition comprising at least one silk protein, wherein the composition comprising at least one silk protein comes into direct contact with the implantable hair.

27. The implantable hair according to claim 26, wherein the at least one silk protein has at least 90% amino acid sequence homology to a spider silk protein or an insect silk protein.

28. The implantable hair according to claim 26, wherein the at least one silk protein is: (a) selected from the group consisting of fibroin, sericin, spidroin 1 and spidroin 2; or (b) comprises at least two sequence sections each having one of the following sequences SEQ ID NO: 1 to 6: TABLE-US-00009 (SEQ ID NO: 1) GPGXX, (SEQ ID NO: 2) GVPGX, (SEQ ID NO: 3) GSGXX, (SEQ ID NO: 4) GGYXX, (SEQ ID NO: 5) PQQXX, (SEQ ID NO: 6) GYGXX, wherein X is a natural amino acid.

29. The implantable hair according to claim 26, wherein the at least one implantable section is an implantable terminal end of the hair, an implantable kink that is not located at a terminal end of the hair, or a kinkable portion that is not located at a terminal end of the hair.

30. The implantable hair according to claim 26, wherein the implantable hair is a human hair.

31. The implantable hair according to claim 26, wherein the implantable hair comprises a human hair, wherein the human hair was removed from its follicle, root, and bulb.

32. The implantable hair according to claim 26, wherein the implantable hair comprises a synthetic hair or an animal hair.

33. The implantable hair according to claim 26, wherein the implantable hair, over its entire length, has an average diameter of 0.02 to 0.15 mm.

34. The implantable hair according to claim 26, wherein the implantable hair comprises at least one of the following features: (1) an implantable section with a circumference of no more than twice the average circumference of the hair; (2) an implantable section, wherein the coating composition thickens the implantable section to a maximum circumference of at least twice the average circumference of the uncoated section of the hair; (3) an implantable section comprising an artificial anchoring structure, wherein the structure is, optionally, selected from the group consisting of the form of a cone, a frustocone, a thickened cylinder, a mushroom-shaped, a droplet form, an ellipsoid, a cuboid, a spiral form, a screw form, a ring form, a sphere, a honeycomb structure, a partial wrapping of the hair with a fiber or a tape, and a combination of two or more of the foregoing option, and may optionally, comprise appendages that project from the hair structure and/or the anchoring structure; (4) an implantable section comprising at least one notch; (5) an implantable section comprising a hair follicle, a hair root, and/or a hair bulb coated with the composition; (6) an implantable section comprising zones, wherein the coating imparts different strength and/or biological stability in comparison to uncoated sections of the implantable hair, optionally wherein the different strength and/or biological stability is higher in the interior of the hair than it is on the outside of the hair; and (7) the composition comprising at least one silk protein or degradation product thereof which, after implantation, is transported onto the hair outside the body and/or the scalp, where it nourishes the hair and/or the skin.

35. The implantable hair according to claim 26, wherein the composition comprising at least one silk protein is coated onto the hair using 3D shaping, optionally 3D printing.

36. The implantable hair according to claim 35, wherein the composition comprising at least one silk protein is at least partially melted when coated on the implantable section, optionally wherein a femtosecond laser is used to melt the at least one silk protein.

37. The implantable hair according to claim 26, wherein the silk protein was partially removed, optionally by using plasma ablation or a femtosecond laser.

38. The implantable hair according to claim 26, wherein the composition comprising at least one silk protein is pasty or solid, and wherein the implantable hair has a 3D surface structure in the nano- or micrometer range that differs from a largely cylindrical form.

39. A method of producing the implantable hair of claim 26, wherein the method comprises the following steps: (i) providing: (A) a hair that is not on a human or animal body, and (B) a composition comprising at least one silk protein; and (ii) contacting the at least an implantable section of the hair with the composition comprising at least one silk protein.

40. The method according to claim 39, wherein the composition is a liquid or pasty or a solid composition, and the method further comprises the step of: (iii) drying the implantable hair obtained from step (ii).

41. The method according to either of claim 39, wherein the composition comprising at least one silk protein is pasty or liquid, and wherein the contacting step (ii) comprises dipping the hair or a section thereof into the liquid or pasty composition comprising at least one silk protein.

42. The method according to claim 39, wherein the contacting step (ii) comprises coating or spraying of the hair or a section thereof with the composition comprising at least one silk protein.

43. The method according to claim 39, wherein the contacting step (ii) comprises sticking the composition to the hair or a section thereof by means of a 3D shaping method, thereby resulting in a 3D surface structure in the nano- or micrometer range that differs from a largely cylindrical form.

44. The method according to claim 39, wherein the contacting step (ii) comprises sticking the composition to the hair or a section thereof by partially melting the composition comprising at least one silk protein.

45. The method according to claim 39, wherein the method further comprises a step of partly removing silk protein that has been applied to the hair.

46. The method according to claim 39, wherein the method comprises the following steps: (i) providing: (A) hair that is not on the human or animal body, and (B) a largely solid or pasty composition comprising at least one silk protein that may optionally constitute one or more fibers or an at least partly dried composition comprising at least one silk protein; (ii) contacting or maintaining contact of at least an implantable section of the hair with the composition, where steps (i) and (ii) may optionally also take place simultaneously, (iii) sticking the composition to the hair or a section thereof by partially melting the composition, optionally by using a pulse of light, optionally a pulse of light from a femtosecond laser, preferably forming a 3D surface structure in the nano- or micrometer range that differs from a cylindrical form.

47. A cosmetic use of the implantable hair of claim 26 for implanting into human or animal skin.

48. A cosmetic method of implanting the implantable hair of claim 26 into human or animal skin comprising implanting the implantable hair of claim 26 into the human or animal skin by means of a needle.

49. A method of cosmetic haircare, comprising a step of applying a liquid or pasty or solid composition comprising at least on silk protein to hair, wherein the hair is selected from the group consisting of: (a) implanted implantable hair according to claim 26 on the head or body; (b) hair extensions; (c) stickable eyelashes; (d) eyelash extensions; (e) wigs; and (f) toupees, wherein the method comprises the step of applying a liquid or pasty or solid composition containing at least one silk protein to the hair.

50. A method of cosmetic haircare, comprising a step of applying a liquid or pasty or solid composition comprising at least one silk protein to the hair, wherein the hair: (a) has been lightened and/or colored prior to the step of applying the composition containing at least one silk protein; (b) is lightened and/or coloured during the step of applying the composition containing at least one silk protein; or (c) is lightened and/or coloured after the step of applying the composition containing at least one silk protein.

Description

DESCRIPTION OF THE FIGURES

[0243] FIG. 1 shows a schematic of the hair implantation of one or more hairs (2) into the human scalp (1). It is additionally shown that the implantation of hair can also be effected in the region of the eyebrow (3), of the eyelashes (4), of the moustache (5) or of the beard (6) (for example the chin or cheek area of the beard or sideburns). It is likewise possible to conduct the implantation of hair at other places on the body as well. For better illustration, the transplantation of hair is shown viewed through a magnifying glass (7), with the coating of the implantable section (here by way of example of the implantable terminal end) of a hair (2) in FIG. 1 represented by way of example as a simulation of a hair root or a hair follicle or a hair bulb (8) comprising silk protein (e.g. spider silk and/or caterpillar silk).

[0244] FIGS. 2 to 27 show examples of structures that can serve for anchoring of the implantable hair (2) according to the invention. For instance, it is possible to use a structure in the form of a simulation of a hair root or a hair follicle or a hair bulb (8) and comprising silk protein (e.g. spider silk and/or caterpillar silk) that optionally comprises an additional anchor structure (9). It is also possible for a structure that can serve for anchoring of the implantable hair (2) according to the invention to have one or more incisions (10) and hence to achieve improved anchoring. As can be seen in the figures, an anchoring may optionally contain an additional anchor structure (9) composed of a composition comprising silk protein (e.g. spider silk and/or caterpillar silk) or coated therewith, which has the function of barbs, a spiral form as in the case of a screw or protuberances (9) in order to enable or to improve the securing of the hair implant. It is also possible for the coating, the optional anchoring and/or the optional structures of the anchoring to have different strengths. In addition, the anchoring (9) may be annular, which can improve the ingrowing of the surrounding tissue. It is also possible for the anchoring (9) optionally to have one or more appendages with a composition containing silk protein (e.g. spider silk and/or caterpillar silk) that are connected to the anchoring by a kind of bridge or any other form of connection. The anchoring may also have a structure, for example in honeycomb form, that may have a higher hardness than the surrounding anchoring. The implanted hair (2) may optionally have a complete or partial sheath (11), preferably in the implantable section thereof, consisting of a composition comprising silk protein (e.g. spider silk and/or caterpillar silk). It is also possible for an implantable hair (2) to comprise a natural/real hair root (12) and/or hair follicle and/or hair bulb that may be surrounded by a coating (13) with a composition comprising silk protein (e.g. spider silk and/or caterpillar silk).

EXAMPLE

[0245] The spider silk may be obtained in various ways. By way of example, a silk protein as described in WO 2007/025719 and WO 2006/008163 is used, i.e. a fibroin-3 and/or -4 from the European garden spider (Araneus diadematus). This is also referred to as “Araneus diadematus fibroin 3” (ADF-3) or “Araneus diadematus fibroin 4” (ADF-4) or else as (“Major Ampullate Spidroin II” or “Spidroin 2”). The ADF-3 and/or ADF-4 spider silk protein which is described here by way of example can be obtained commercially. It was produced as described in WO 2006 008163. Hence, in a bacterial fermentation process, bacteria were produced by Escherichia coli (also called E. coli or colibacterium). Spider silk protein-encoding DNA from the European garden spider (Araneus diadematus) was inserted into the E. coli bacteria by gene transfer. This created genetically modified E. coli bacteria that express spider silk protein by fermenting beets or sugarcane, for example.

[0246] The implantable hair for implantation comes mainly from India. It is customary for Hindu pilgrims to sacrifice their hair after taking a vow or when starting a new stage in their life. This takes place predominantly at Indian temples, and therefore the hair is also referred to as temple hair. In order to prepare the hair for the European market, for example, they are sorted according to their properties, for example according to the length, bundled, bleached and coloured.

[0247] For the implantation of the implantable hair, however, it is also possible to cut off endogenous hair. In order to assure good quality, it should if at all possible be unbleached and uncoloured. For coating of the implantable hair, it is sorted and fixed by bundling in narrow strips. At the terminal end of the hair, the hairs are cut off with a very sharp blade in order that they all end in the same place. This ensures that every single hair is coated with silk. This is followed by the coating with silk by immersing the implantable section of the hair into liquid or pasty composition or rubbing on the solid composition. For better distribution of the silk, the bundle of hair is rotated while being immersed into the liquid or pasty composition.

[0248] Thereafter, the hair is subjected to drying. For acceleration of drying, it is subjected to gentle air ventilation. For formation of further silk coatings, the hair, after the silk layer has dried, is immersed again into the liquid or pasty composition by the same principle.

[0249] These process steps are repeated until the desired thickness of the protective layer around the implantable hair and the anchoring has been attained. In order additionally to establish a mushroom-shaped anchoring, for example, the end of the hair to be implanted, starting from a certain process repetition, is immersed into the liquid or pasty composition only up to the place where the mushroom cap-shaped broadening is to form.

[0250] Prior to implantation, the scalp is first locally anaesthetized. This is done with a plunger filled with a local anaesthetic, for instance by means of the “Comfort-in” injection device (Mika Medical Co. 93, Noksansaneopjung-ro, Gangseo-gu, Busan, Republic of Korea). This plunger has, at the lower end, a nozzle having an opening of about 0.15 mm. As soon as the trigger is pressed, the plunger is in contact with the skin for about 0.3 seconds, and within this short space of time applies the anaesthetic at high pressure beneath the skin, which leaves it undamaged. This anaesthetizes all layers of the skin.

[0251] In order to implant the implantable hair into the skin, especially the scalp, a specific device known for this purpose in the art is used, which is similar to a propelling pencil. For this purpose, it is possible, for instance, to use conventional CII hollow needles (punches) from Cole Instruments Inc. (1070 Powers Place, Alpharetta GA 30009 USA) with appropriate commercially available additional equipment. Such a device comprises an outer hollow needle with which the skin is penetrated and an inner hollow needle into which the implantation hair is introduced and in which it is held by a clamping mechanism. At the hold point is an advance mechanism (likewise similar to a propelling pencil), with the aid of which the implantation hair is pushed about 1 mm out of the tip of the inner hollow needle at its terminal end. The electrical trigger mechanism for advancing the inner hollow needle and releasing the hold is controlled by actuating a foot pedal.

[0252] The internal diameter of the inner hollow needle may be about 0.05 to 0.6 mm broader than the anchoring of the hair implant. The inner diameter of the outer hollow needle is only broader to the extent required for the inner hollow needle to be able to slide through. The outer diameter of the outer hollow needle is about 0.2 to 0.9 mm wide.

[0253] The implantation device, in the direction of hair growth, is leant against the skin at an angle corresponding to the natural exit angle of the hair, at about 45 degrees. The outer hollow needle is introduced into the skin. Then the trigger pedal is pressed, as a result of which the inner hollow needle is pushed forward automatically through the outer hollow needle. As soon as the inner hollow needle reaches the tip of the outer hollow needle, the hair is pushed forward by the advance mechanism. As soon as the hair has advanced as described, the clamp mechanism is released automatically and the hair is released. Then the implantation device is removed again from the skin and prepared for the implantation of the next hair.

[0254] An alternative method is the implantation of the hair with a device as already used in the transplantation of endogenous hair. For this purpose, for example, it is possible to use the “OKT Implanter” manufactured by Cole Instruments Inc. (1070 Powers Place, Alpharetta GA 30009 USA), the needle of which may have a diameter of 0.6 to 1.14 mm. In the transplantation of endogenous hair, the hair removed, together with its hair root, is placed into a needle having an incision on one side or a passage opening. Then the hair is pushed into the scalp and implanted. Also in the case of implantation of implantable hair according to the invention with a coating containing at least one silk protein and optionally having an anchoring structure, the hair together with the anchoring can be placed into the needle of the OKT Implanter, pushed into the skin and implanted. It is possible here for the hair to hang out at the needle opening, which makes it possible to implant long hair has well.

[0255] Depending on the number of implantable hairs to be implanted, a treatment may take a few hours to a few days.