RU2776439C2 - Hair implants with enhanced fixation and medical safety characteristics - Google Patents

Abstract

FIELD: medicine; cosmetology.

SUBSTANCE: invention relates to the field of hair replacement and, in particular, to the implantation of artificial hair and implants. A hair implant is designed for subcutaneous implantation, includes an anchor and at least one strand of hair. The anchor contains an anchor body and at least one collagen-receiving structure selected from a group consisting of at least one channel passing through the anchor body and an element of the outer surface of the anchor body. At least one strand of hair protrudes from the distal end of the anchor body. At least one collagen-receiving structure is made with the possibility of supporting the growth of the collagen ligature after subcutaneous implantation of the hair implant in such a way that to fix the anchor on a recipient of the hair implant, and there is no hair in the collagen-receiving structure. A method for hair restoration includes the formation of an incision on the skin; the introduction of the above-mentioned implant into the incision so that 0.1-2 mm of silicone coating at the proximal end of each of at least two strands of hair remains: a) outside the skin, b) above the epidermis, c) under the skin or d) under the epidermis; as well as application of adhesive to the incision. A method for the manufacture of the above-mentioned implant includes provision of a mold containing at least one cavity for forming an anchor; filling at least one cavity with silicone liquid; coating 2-10 mm of the proximal end of each of at least two strands of hair with silicone coating; immersion in silicone liquid of the proximal end of each of at least two strands of hair to such a depth so that 0.1-2 mm of silicone coating remains outside silicone liquid in the cavity; solidification of silicone liquid to produce a solid product; extraction of the solid product from the mold; and sterilization of the solid product in such a way that to prepare the implant.

EFFECT: use of inventions makes it possible to fix a hair implant to prevent unwanted hair loss, protect the artificial hair implant from the immune system and prevent inflammation in the short and long term.

54 cl, 33 dwg

Description

This application claims benefits under 35 U.S.C. §120 of Application #15/665369, filed July 31, 2017 (currently U.S. Patent #9,993,334) and also claims benefit under 35 U.S.C. §120 of Application No. 15/718637, filed September 28, 2017, both of which are HAIR IMPLANTS WITH REINFORCED FIXATION AND MEDICAL SAFETY FEATURES, and the full disclosure of which is incorporated herein by reference. Application No. 15/718637 is also a continuation in part and claims benefit under 35 U.S.C. §120 application no. 15/665369.

BACKGROUND TO THE INVENTION

1. FIELD OF THE INVENTION

[0001] The present invention relates to the field of hair replacement and, in particular, to the implantation of artificial hair and implants.

2. DESCRIPTION OF THE PRIOR ART

[0002] For millennia, men and women have been harassed, ridiculed, and even suicidal due to hair loss and the physical and cosmetic impact that hair loss has on their appearance, especially hair loss on the scalp or face (2- 6). The causes of hair loss are numerous, including genetic disorders, genetic inheritance, stress due to illness, fever or physical activity, chemotherapy, hair pulling, curling with a curling iron, chemical treatment of the hair to shape or color it, etc. ., aging, poor nutrition, thyroid disease, ringworm, and many other skin and non-skin diseases that can be listed at length (1, 7, 30, 52, 90, 91). Treatments for hair loss, including medical and non-medical treatments, have produced poor to satisfactory results in most cases (9–14, 26, 27, 59, 92, 93).

[0003] Treatment of hair loss with currently available options does not meet the vast majority of patient expectations, regardless of whether the treatment is surgical, medical or non-pharmacological. Other factors, indirectly related not only to hair loss, but also to the way hair care procedures look, have a much greater impact on a person's mental and physical health. These factors include the psychological, social and emotional trauma caused by how a person looks and feels after hair loss, as well as existing inadequate solutions. The degree of psychological, social and emotional trauma does not end there. Long-term anxiety and stress can also affect a person's physical well-being (2-6).

[0004] Hair restoration that meets many if not all of the key patient expectations, such as hair appearance and natural feel, providing good hair density, low risk of complications with affordability, and very low maintenance, will not only be in high demand, but will reduce stress, anxiety, social and physical impacts on a person's life. In addition, a more natural solution to hair loss will result in a very happy, confident, positive attitude and sense of well-being that, if calculated, will eliminate many of the financial, social, and emotional problems faced by those affected by hair loss (2 -6).

[0005] Currently, there are many hair replacement techniques and methods, including wigs, hair extensions, braiding and hair extensions, hair implantation, hair transplantation, and some drug treatments with minoxidil, finasteride, etc., which promise hair growth . All of these tools provide limited success in one way or another, and these limitations not only prevent the optimization of expectations, but also lead to emotional failure.

[0006] Wigs, braids, and hair extensions often do not look or feel natural, leading not only to ridicule, but to feelings of embarrassment or real awareness of how unnatural the hair system can look. In addition, these wigs, extensions or weaves can cause chronic skin irritation leading to damage and complete loss of the remaining natural healthy hair.

[0007] Hair transplant surgery, another solution for hair loss (26, 27), is not only a very expensive, but also a very invasive surgical procedure with numerous medical risks, including infection and scarring of the scalp, dysplasia, and unnatural appearance. (26-30, 54, 55, 57, 95, 96, 99). Even if the hair transplant operation is successful, without scarring, infection or failure of hair growth, in most cases, the resulting hair density will still be insufficient (due to the limited ability of the skin to heal), the appearance in the hairline will be unnatural due to ulceration of the skin (as a result of a surgical trauma to the skin of the recipient), and the transplanted hair fibers will have an inappropriate diameter (very thin hair fibers that are difficult to collect must be placed on the hairline for a natural transition) - all this leads to an unnatural appearance.

[0008] Medical treatment of the underlying disease that caused hair loss may cure the disease itself, but usually does not lead to hair restoration due to injury and death of the hair follicle. And so patients are looking for a hair restoration solution (1, 7). There are some diseases that do not have medical, non-pharmacological or surgical treatment, such as some types of alopecia (9).

[0009] Medical pharmacological therapies can directly prevent or stimulate hair growth, such as finasteride and minoxidil (10-14, 59). Not only do these medications work poorly for hair growth, but they are not harmless treatments with no risks or side effects. Finasteride, for example, can not only lead to loss of libido, but also increase the risk of developing a more aggressive type of prostate cancer. Minoxidil, a topical drug, is problematic because it can lead to hair growth on other parts of the body, such as the face, arms, legs, and chest, a side effect that many men and especially women find frightening. In addition, minoxidil can lower blood pressure and the person may faint or lose consciousness.

[0010] Artificial hair implantation, another method of hair restoration, is currently banned in the United States, but allowed in Europe and other countries (15). Hair implantation is associated with many risk factors such as pain, scarring, scalp infections, chronic inflammation, as well as deep scalp abscesses and granuloma formation. Numerous medical articles have been published advising against hair implantation due to these complications (16–19, 60, 98).

[0011] Hair implantation is currently banned in the United States, and the US Food and Drug Administration's ruling on this issue has been in place for many decades (15). Even though some individual reports claim some success with artificial hair implants (21, 61-65, 87, 100, 101), the US Food and Drug Administration has banned this method of artificial hair implantation due to numerous patient complaints and complications, including infections, scarring, chronic inflammation, and other problems (15–19, 60). Although artificial hair implantation is banned in the United States, it appears to be legal in many parts of the world, including Asia and Europe. There are currently two companies that manufacture artificial hair for implants, Nido (Japan) (20) and Biofibre (Italy) (21), and have been selling these artificial hair implants for decades.

[0012] US Pat. No. 5,061,284 Laghi (101) describes a hair implant sample in which the implanted hair consists essentially of a human hair on which an artificial follicle is formed. The silicone follicle encapsulates the end of the hair shaft. Laghi claims to place the hair shaft directly in the middle of the anchor. Thus, in the prior art of Laghi there is no information from the present invention (see Fig. 14 d). In addition, US Pat. No. 3,596,292 Erb (100) describes a hair implant structure having an anchor portion below the skin surface and in the subcutaneous fascia containing tissue-permeable structures in the form of microfibers, microporous polymers, reticulated foam polymers or hydrated hydrogels. A network of polymeric material surrounds the hair fiber. Erb claims to place the hair shaft directly in the center of the anchor. Thus, in the prior art of Erb, there is no information from the present invention, (see Fig. 146).

[0013] Another example of a hair implant is disclosed in US Pat. No. 9,492,196 to Keren (87), which describes an anchor formed with a rough surface and a slit or hole through which the hair is inserted so that the bulbous end of the root is implanted into the target tissue. The open slit is sized to keep the bulbous end of the hair from passing through. Two open flaps are located above the non-closable hair slot. Keren claims to place the hair shaft directly in the center of the anchor. Thus, in the prior art of Keren, there is no information from the present invention (see Fig. 14c). In this case, in the present invention, the channel is located between the first hair chamber and the second hair chamber. Part of the hair strand is placed in the corresponding hair chamber on the side of the channel and away from the anchor axis (see Fig. 14a).

[0014] The three most commonly reported complications resulting from the use of commercially available hair implant products are infection, inflammation, and scarring. The cause of these complications is related to the type of materials used, the specific design of the materials, and how (using which surgical method) they are attached to the skin. If materials, designs and techniques were improved, the risks and complications would be greatly reduced, making artificial hair implantation an acceptable alternative hair restoration solution for hundreds of thousands of hair loss patients worldwide.

[0015] The materials used in the current production of artificial hair implants include, in general, natural or artificial hair. Hair, whether natural or artificial, is a highly antigenic reactive substance when encountered or evaluated by the immune system (22, 23). Given the hyper-reactivity and immune response to currently used materials, there appears to be little or no medical consideration regarding the choice of material and how to minimize this negative interaction with the body. When this hair implant is placed deep into the scalp, the longest part of the hair is in direct contact and is completely unprotected from the blood or the immune system. This deep location and direct contact of the hair with the body will greatly increase the potential for triggering an intense and chronic inflammatory response leading to chronic inflammation, pain, infection, granuloma formation and other serious problems.

[0016] The current hair implant design is rather rudimentary, again not reflecting any medical considerations regarding the associated natural anatomy, physiology, immunology, or microbiological factors. This design develops inflammatory interactions with the body and does not provide a proper barrier for microbiological (bacterial) protection. In addition, there is no element in the design of the hair implant that even tries to stop the entry of foreign invaders (bacteria) into the body, which, in the absence of a barrier in the composition of the hair implant design, can cause serious acute and long-term chronic infections.

[0017] Current hair implantation techniques involve placing artificial hair deep into and under the skin. This deep placement involves tunneling artificial hair under the skin and then attaching it to a deep fascia called the Galea Aponeurotica that lies just above the skull. The formation of a loop and fixation of the artificial hair in the deep fascia is an anchoring mechanism that protects the hair from falling out. While this is a very safe attachment technique, it does not, again, allow for medical considerations regarding adverse immune system interactions or an appropriate bacterial barrier to prevent infection, and thus inflammation and infectious complications follow. It must be taken into account that this technique, with a very deep and specific placement in the fascial tissue type, is limited to the scalp area and does not allow the placement of hair in any other part of the body. In addition, there are serious problems inherent in this attachment technique, which include a high risk of chronic inflammation, abscess formation, severe scarring and granulomas, etc. These complications may arise because the implanted artificial (or natural) hair is not protected or is in direct contact with the immune system, and there is no barrier mechanism to prevent bacteria from entering. In addition, the implanted hair fiber can break down or fragment, leaving highly antigenic pieces of hair deep in and under the skin, leading to acute and chronic inflammation, potential cyst and granuloma formation, chronic pain, and scarring.

[0018] Accordingly, it is desirable to provide improved artificial hair implants and hair restoration methods using them. In addition, it is desirable to provide artificial hair implants that provide a natural appearance, are designed to be safely implanted into the skin, do not cause an antigenic or inflammatory response, and can be implanted to create a variety of hair density and contour.

[0019] All references herein are incorporated by reference in their entirety.

SUMMARY OF THE INVENTION

[0020] A first aspect of the invention is a hair implant comprising: at least two tufts of at least one mammalian hair and a synthetic hair; and an anchor that: (a) is composed of silicone, (b) is shaped for subcutaneous implantation, (c) has a fracture line shaped to facilitate breaking of the anchor along the fracture line for easy removal of the implant after subcutaneous implantation, and (d) is shaped to provide scaffold for collagen growth after subcutaneous implantation, where at least one of at least two strands is connected to an anchor on one side of the fracture line and at least one of at least two strands is connected to an anchor on opposite side of the fracture line such that each fragment formed by the implant fracture contains at least one of the at least two strands.

[0021] In certain embodiments, at least two strands are synthetic hairs containing a fiber of a polymer selected from the group consisting of polypropylene, polyvinyl chloride, polyamide, polyethylene, polyacrylonitrile, polyvinylidene chloride, polyurethane, polyester, and their copolymers.

[0022] In certain embodiments, at least two of the strands have a diameter of 0.01 to 3 mm, or 0.02 to 0.2 mm.

[0023] In certain embodiments, at least two strands are 1 mm to 500 cm long, or 1 cm to 50 cm long.

[0024] In certain embodiments, the largest anchor size is 0.1 mm to 2.5 mm, or 0.1 to 5 mm.

[0025] In certain embodiments, the diameter of the anchor decreases from the proximal end to the distal end.

[0026] In certain embodiments, the diameter of the anchor increases from the proximal end to the distal end.

[0027] In certain embodiments, the diameter of the anchor is substantially constant from the proximal to the distal end.

[0028] In certain embodiments, the anchor has a midsection concavity that is approximately equidistant from the proximal to the distal end of the hair implant.

[0029] In certain embodiments, the anchor has an open channel at at least one of the distal ends and proximal ends of the anchor.

[0030] In certain embodiments, the anchor has at least one open channel, at least one closed channel, and at least one bridge between two vertical components.

[0031] In certain embodiments, the implementation of the anchor has a bump on its distal side, and the specified bump effectively prevents the penetration of bacterial infection.

[0032] In certain embodiments, the anchor has at least one channel formed to receive and hold collagen ligatures so as to attach the anchor to a hair implant recipient.

[0033] In certain embodiments, the implementation of the anchor consists of silicone.

[0034] In some embodiments, the anchor does not have hinged flaps.

[0035] In certain embodiments, the implementation of the hair implant does not contain metal components.

[0036] A second aspect of the invention is a method for restoring hair, comprising: inserting a needle into the skin to form an incision; introduction of the implant of the invention into the incision so that 0.1-2 mm of silicone coating at the proximal end of each of at least two strands

[0037] In certain embodiments of the method, the incision is made to a depth of 2-8 mm.

[0038] In certain embodiments of the method, the adhesive is cyanoacrylate.

[0039] In certain embodiments of the method, the collagen penetrates the channels of the anchor, forming ligatures that bind the implant.

[0040] In certain embodiments of the method, the implant is inserted into the incision such that 0.1-2 mm of the silicone coating at the proximal end of each of the at least two strands remains outside the skin or above the epidermis.

[0041] In certain embodiments of the method, the implant is inserted into the incision such that 0.1-2 mm of the silicone coating at the proximal end of each of the at least two strands remains under the skin or under the epidermis.

[0042] A third aspect of the invention is a method for manufacturing an implant of the invention, comprising: providing a mold containing at least one cavity for forming an anchor; filling at least one cavity with silicone fluid; coating 2-10 mm of the proximal end of at least one strand with a silicone coating; immersing at least one strand in the silicone fluid of the proximal end to such a depth that 0.1-2 mm of the silicone coating remains outside the silicone fluid in the cavity; solidifying the silicone fluid to obtain a solid product; removing the solid product from the mold; and sterilizing the solid product so as to prepare an implant.

[0043] A fourth aspect of the invention is a hair implant, comprising: at least one strand containing at least one mammalian hair and synthetic hair; and an anchor that: (a) contains silicone, (b) is formed for subcutaneous implantation, (c) contains a fracture line designed to facilitate breaking of the anchor along the fracture line for easy removal of the implant after subcutaneous implantation, and (d) is formed to provide a scaffold for collagen growth after subcutaneous implantation, wherein at least one strand is located in the inner hair capsule leading from the first distal hole to the second distal hole in such a way that each end of at least one strand remains outside the anchor.

[0044] A fifth aspect of the invention is a hair implant suitable for subcutaneous implantation, which includes:

a. hair strand anchor, comprising:

i. anchor body;

ii. a first hair capsule located inside said anchor body;

iii. a second hair capsule located inside said anchor body; and

iv. at least one channel passing through said body of the anchor, said channel is located further between said first hair capsule and said second hair capsule, while there is no hair in the channel; and

b. at least one strand of hair, part of which is held in at least one of the hair capsules, moreover, this retained part of the hair strand is additionally enclosed in the specified hair capsule;

wherein said channel is formed to support the growth of a collagen ligature after subcutaneous implantation of a hair implant, wherein said channel is formed to receive and hold collagen ligatures capable of attaching said hair strand anchor to a hair implant recipient.

[0045] In certain embodiments of the hair implant, said strand of hair is a strand of human hair or a strand of synthetic hair.

[0046] In certain embodiments of the hair implant, said anchor body is made from a biocompatible polymer, silicone, silicone polymer, metal, or metal alloy.

[0047] In certain embodiments of the hair implant, at least one end of the hair strand protrudes from the distal end of the anchor body.

[0048] In certain embodiments of the hair implant, said first hair capsule is smoothly connected to said second hair capsule to form a U-shaped hair capsule in which said hair strand is held in said U-shaped hair capsule such that both ends of said hair strand protrude from the distal end of the anchor body.

[0049] In certain embodiments, the implementation of the hair implant contains at least two strands of hair, and, the proximal end of each strand of hair is located and enclosed in one of these hair capsules.

[0050] In certain embodiments of the hair implant, the channel is an open channel passing through the body of the anchor at its distal or proximal end.

[0051] In certain embodiments of the hair implant, the channel is a closed channel passing through the body of the anchor.

[0052] In certain embodiments of the hair implant, the anchor body has at least two channels extending through it.

[0053] In certain embodiments of the hair implant, the at least two channels are parallel open channels located at opposite ends of the anchor body.

[0054] In certain embodiments of the hair implant, the at least two channels are parallel closed channels extending through the body of the anchor.

[0055] In certain embodiments of the hair implant, at least one of the channels is an open channel located at the distal or proximal end of the anchor body, and at least one of the channels is a closed channel passing through the anchor body.

[0056] In certain embodiments of the hair implant, a channel through the anchor body substantially creates a longitudinal fracture line through said anchor body that intersects the channel.

[0057] A sixth aspect of the invention is a subcutaneous implantable hair implant, comprising:

a. hair strand anchor, comprising:

i. body of the first anchor;

ii. body of the second anchor; and

iii. at least one bridge connecting said body of the first anchor with said body of the second anchor so as to connect at least

one cavity between said anchor bodies, moreover, there is no hair in said cavity; and

b. at least one strand of hair, a portion of which is located in at least one of the anchor bodies, wherein said retained portion of the hair strand is additionally enclosed in said anchor body;

wherein said bridge connecting said anchor bodies is formed to support and retain the growth of collagen ligature after subcutaneous implantation of the hair implant, where said collagen ligatures are formed to secure said hair strand anchor to the hair implant recipient.

[0058] In certain embodiments of the hair implant, said strand of hair is a strand of human hair or a strand of synthetic hair.

[0059] In certain embodiments of the hair implant, said hair strand anchor is made from a biocompatible polymer, silicone, silicone polymer, metal, or metal alloy.

[0060] In certain embodiments of the hair implant, each of said anchor bodies has a hair capsule located therein.

[0061] In certain embodiments, the implementation of the hair implant contains at least two strands of hair, and the proximal end of each strand of hair is located and enclosed in one of these hair capsules.

[0062] In certain embodiments of the hair implant, said first anchor body hair capsule is smoothly connected to said first anchor body hair capsule to form a U-shaped hair capsule, wherein said portion of the hair strand is located in said U-shaped hair capsule such that both ends of said hair strand protrude from the distal end of the hair strand anchor.

[0063] In certain embodiments of the hair implant, a portion of said U-shaped hair capsule is located in said bridge.

[0064] A seventh aspect of the invention includes a method for subcutaneously implanting a hair implant into a hair implant recipient. The method includes:

a. providing any of the hair strand anchors described herein;

b. applying an adhesive to a portion of the first strand of hair;

in. introducing said portion of the first hair strand into the first hair capsule;

d. applying an adhesive to a portion of the second strand of hair;

e. inserting said portion of the second hair strand into a second hair capsule;

and

e. inserting the hair strand anchor into the subcutaneous fascia of the recipient, thereby causing a foreign body reaction whereby the anchor is encapsulated by collagen and the growth of the collagen ligature passes through the channel of the anchor, thereby attaching said hair strand anchor to the hair implant recipient.

[0065] In the first preferred embodiment of the method of insertion from the proximal and distal hair, first not glued, but inserted into the proximal opening of the vertical component of the hair capsule, then the hair is pushed until only 6 mm of the proximal end is visible, then to this 6 The adhesive is added to the end, and finally the hair continues to be pushed until it is completely in the hair capsule.

[0066] In a second preferred embodiment of the method of administration from proximal to distal, the hair is not first glued, but knotted at its proximal end, or otherwise processed (e.g., by melting or enlarging the knot of a binder, such as an adhesive) to provide a bulbous end, smaller than the larger opening of the nodal capsule and larger than the smaller opening of the nodal capsule, and then fed into the proximal opening of the nodal capsule until only about 6 mm of the proximal end of the hair is visible. Adhesive is then applied to this 6 mm end (which will contain the knots) and then the hair continues to be fed through the hair capsule until it reaches the most distal end of the capsule knot.

[0067] In certain embodiments of the hair implant, said at least one cavity effectively creates a longitudinal fracture line through said hair strand anchor that intersects said bridge.

[0068] In certain embodiments, the hair implant further comprises at least a second bridge connecting said first anchor body to said second anchor body and connecting at least one cavity between said anchor bodies.

[0069] In certain embodiments of the hair implant, said second bridge is parallel to the first bridge.

[0070] An eighth aspect of the invention is an anchor comprising: (a) a first hair capsule formed to receive at least one strand of hair; (b) a second hair capsule formed to receive at least one strand of hair; and (c) at least one channel passing through said anchor between the first hair capsule and the second hair capsule, wherein: (i) the anchor is formed for subcutaneous implantation of at least one strand of hair secured in at least one of the first hair capsule and the second hair capsule; (ii) the channel is formed to support the growth of the collagen ligature after subcutaneous implantation by obtaining and retaining collagen ligatures capable of attaching the anchor to the hair implant recipient.

[0071] In certain embodiments of the anchor, at least one channel defines a longitudinal fracture line through the anchor that intersects the channel such that the anchor is formed to break along the fracture line when sufficient force is applied to facilitate removal of the anchor.

[0072] One of the unique and innovative technical features of the present invention is a channel (or cavity) located inside (for example, in the middle) of the anchor between the hair capsules, which allows the casing surrounding the anchor around the channel to protect this channel from tearing into many parts, unlike porous mesh Erb (100). For example, the porous Erb mesh has holes that are not surrounded by the substantial body of the anchor, and the thin walls between the pores may be prone to breaking into several pieces. Moreover, if the channel is destroyed, despite the thickness of the body surrounding the anchor, the channel will be fragmented in a certain way - right in the middle between two hair capsules.

[0073] A ninth aspect of the invention is an anchor that comprises (a) a hair strand anchor, comprising: (i) an anchor body; (ii) a hair capsule located inside the body of the anchor; and (iii) at least one channel through the body of the anchor; and (b) at least one strand of hair, part of which is located and held in the hair capsule; where at least one channel supports the growth of a collagen ligature after subcutaneous implantation of the hair implant, and at least one channel is formed to receive and hold collagen ligatures that are able to anchor the anchor of the hair strand to the recipient of the hair implant.

[0074] In certain embodiments of the anchor, one closed channel extends through the body of the anchor and its adjacent proximal end, and one hair capsule is located along the central longitudinal axis of the hair implant.

[0075] In certain embodiments of the anchor, one open channel extends through the body of the anchor at its proximal end; and a plurality of closed channels also extend through the body of the anchor.

[0076] In certain embodiments of the anchor, the plurality of closed channels are two parallel closed channels.

[0077] In certain embodiments of the anchor, a single open channel is located between parallel closed channels.

[0078] A tenth aspect of the invention is a hair implant suitable for subcutaneous implantation, which contains: (a) an anchor, consisting of: (i) an anchor body; and (ii) at least one receiving collagen structures selected from the group and consisting of a channel passing through the body of the anchor, and the outer surface of the body of the anchor; and (b) at least one strand of hair protruding from the distal end of the body of the anchor, wherein the at least one collagen receiving structure supports the growth of a collagen ligature after subcutaneous implantation of the hair implant so as to secure the anchor to the recipient of the hair implant.

[0079] In certain embodiments of the hair implant, at least one strand of hair has a diameter of 0.02 to 0.2 mm.

[0080] In certain embodiments of the hair implant, at least one strand of hair is between 1 cm and 50 cm in length.

[0081] In certain embodiments of the hair implant, at least one strand of hair is a strand of human hair or a strand of synthetic hair.

[0082] In certain embodiments of the hair implant, at least one strand of hair is a synthetic hair containing polymeric fibers selected from the group consisting of polypropylene, polyvinyl chloride, polyamide, polyethylene, polyacrylonitrile, polyvinylidene chloride, polyurethane, polyester, and their copolymers.

[0083] In certain embodiments of the hair implant, the largest size of the anchor is 0.1-2.5 mm.

[0084] In certain embodiments of the hair implant, the anchor body comprises a biocompatible polymer, silicone, silicone polymer, metal, or metal alloy.

[0085] In certain embodiments of the hair implant, the anchor is made of silicone.

[0086] In certain embodiments of the hair implant, the anchor does not have hinged flaps.

[0087] In certain embodiments of the hair implant, there are no metal components.

[0088] In certain embodiments of the hair implant, the retained portion of at least one strand of hair is retained in the inner hair capsule of the anchor body.

[0089] In certain embodiments of the hair implant, the inner hair capsule extends from the first distal opening to the second distal opening such that both ends of the at least one hair strand protrude from the distal end of the anchor body.

[0090] In certain embodiments of the hair implant, the proximal end of at least one hair strand is located and enclosed in an inner hair capsule, and the distal end of the at least one hair strand protrudes from the distal end of the anchor body.

[0091] In certain embodiments, the implementation of the hair implant is integral in structure.

[0092] In certain embodiments of the hair implant, at least one collagen receiving structure contains at least one channel.

[0093] In certain embodiments of the hair implant, at least one channel consists of an open channel passing through the body of the anchor through its distal or proximal end.

[0094] In certain embodiments of the hair implant, at least one channel consists of a closed channel passing through the body of the anchor.

[0095] In certain embodiments of the hair implant, the anchor body has at least two channels extending through it.

[0096] In certain embodiments of the hair implant, at least two channels consist of parallel open channels located at opposite ends of the anchor body.

[0097] In certain embodiments of the hair implant, at least two of the channels consist of parallel closed channels extending through the body of the anchor.

[0098] In certain embodiments of the hair implant, at least one of the channels is an open channel located at the distal or proximal end of the anchor body, and at least one of the channels is a closed channel passing through the anchor body.

[0099] In certain embodiments of the hair implant, at least one channel defines a longitudinal fracture line through the body of the anchor that intersects at least one channel.

[00100] In certain embodiments of the hair implant, the anchor has an unevenness on its distal lateral side, whereby said unevenness effectively prevents the penetration of a bacterial infection.

[00101] In certain embodiments of the hair implant, the diameter of the anchor decreases from the proximal end to the distal end.

[00102] In certain embodiments of the hair implant, the diameter of the anchor increases from the proximal end to the distal end.

[00103] In certain embodiments of the hair implant, the diameter of the anchor from the proximal end to the distal end is substantially unchanged.

[00104] In certain embodiments of the hair implant, the anchor has a median concavity that is approximately equidistant from the proximal and distal ends of the hair implant.

[00105] In certain embodiments of the hair implant: (a) the anchor contains silicone; (b) the anchor is made with the possibility of subcutaneous implantation; (c) the anchor contains a fracture line, designed to facilitate the destruction of the anchor along the fracture line for ease of removal of the implant after subcutaneous implantation; (d) the anchor is shaped to provide a platform for collagen growth after subcutaneous implantation; (e) the hair implant contains at least two strands of hair; and (e) at least one of the at least two strands of hair is attached to an anchor on one side of the fracture line, and at least one of the at least two strands of hair is attached to an anchor on the opposite side of the line fracture in such a way that each fragment resulting from the destruction of the implant contains at least one of at least two strands of hair.

[00106] In certain embodiments of the hair implant, the anchor body is comprised of a first inner hair capsule and a second inner hair capsule; at least one receiving collagen structure consists of at least one channel located between the first inner hair capsule and the second inner hair capsule; at least one canal is free of hair; the hair implant contains a plurality of strands of hair; the first inner hair capsule contains a retained portion of at least the first of the hair strands, and the second inner hair capsule contains a retained portion of at least the second of the hair strands.

[00107] In certain embodiments of the hair implant, at least one collagen receiving structure contains at least one channel; the anchor contains the body of the first anchor and the second body of the anchor, connected by at least one jumper, which covers at least one channel; at least one canal is free of hair; the body of the first anchor contains the first inner hair capsule, the second body of the anchor contains the second inner hair capsule, the hair implant contains a plurality of hair strands, the first inner hair capsule encloses the remainder of at least the first of the hair strands, and the second internal hair capsule encloses in itself the remainder of at least the second of the strands of hair.

[00108] In certain embodiments of the hair implant: (a) at least one collagen receiving structure contains at least one channel; (b) at least one canal is free of hair; and (c) the anchor body comprises a first tapered side, a second tapered side, a first inner hair capsule located inside the anchor body parallel to the first tapered side and enclosing the retained portion of at least one first hair strand, a second inner hair capsule located inside the body anchor parallel to the second tapered side and enclosing the retained portion of at least one second strand of hair.

[00109] In certain embodiments of the hair implant: (a) at least one collagen receiving structure contains at least one channel; (b) at least one canal is free of hair; and (c) the anchor body comprises a first vertical side, a second vertical side, a first inner hair capsule located inside the anchor body parallel to the first vertical side and enclosing the retained portion of at least one first hair strand, a second inner hair capsule located inside the body anchor parallel to the second vertical side and enclosing the retained portion of at least one second strand of hair.

[00110] In certain embodiments of the hair implant, the retained portion of at least one strand of hair is retained in one inner hair capsule located along the central longitudinal axis of the hair implant, and at least one collagen receiving structure includes two parallel closed channels on distal end of the hair implant.

[00111] In certain embodiments of the hair implant, the retained portion of at least one strand of hair is retained in one inner hair capsule located along the central longitudinal axis of the hair implant, and at the same time, at least one collagen receiving structure includes one closed channel at the distal end of the hair implant.

[00112] In certain embodiments of the hair implant, at least one web contains four parallel webs that are oval in cross section and enclose three closed channels and two open channels.

[00113] In certain embodiments, the hair implant comprises five parallel closed channels extending through the body of the anchor along a central longitudinal axis, wherein: a) the channels are surrounded by a first inner hair capsule and a second inner hair capsule; b) the top three channels are essentially identical in size; c) the two lower channels are greater than the three upper channels; d) the lower channel is the largest channel; and e) the diameter of the anchor decreases from proximal to distal.

[00114] In certain embodiments of the hair implant, the anchor body comprises a first inner hair capsule and a second inner hair capsule, at least one collagen-receiving structure comprises an outer surface of the anchor body comprising three protrusions on each of two opposite sides of the hair implant, the hair implant contains a plurality of hair strands, the first inner hair capsule encloses a retained portion of at least the first of the hair strands, and the second inner hair capsule encloses a retained portion of at least the second of the hair strands.

[00115] In certain embodiments of the hair implant, the anchor body is cruciform with two hair element arms and two anchor arms, the first hair element arm comprises a first internal hair capsule, the second hair element arm comprises a second internal hair capsule, the hair implant comprises a plurality of hair strands, the first inner hair capsule includes a retained portion of at least the first of the hair strands, and the second inner hair capsule comprises a retained portion of at least the second of the hair strands.

[00116] In certain embodiments of the hair implant, the body of the anchor is in the shape of an inverted Y, including one branch with hair elements and two branches with anchors, the first inner hair capsule in the branch with hair elements, the second inner hair capsule in the branch with hair elements, the hair the implant comprises a plurality of hair strands, the first inner hair capsule encloses the retained portion of at least the first of the hair strands, and the second inner hair capsule encloses the retained portion of at least the second of the hair strands.

[00117] In certain embodiments of the hair implant, the anchor body comprises a first inner hair capsule and a second inner hair capsule, at least one collagen-receiving structure includes an external surface of the anchor body having a plurality of protrusions at the proximal end of the anchor body that curve upward toward the distal at the end of the anchor body, the hair implant contains a plurality of hair strands, the first inner hair capsule encloses a retained portion of at least the first of the hair strands, and the second inner hair capsule encloses the retained portion of at least the second of the hair strands.

[00118] In certain embodiments of the hair implant, the anchor body includes a first inner hair capsule and a second inner hair capsule, at least one collagen-receiving structure comprises an outer surface of the anchor body having a plurality of cup-shaped protrusions surrounding the anchor body with recesses open to to the distal end of the anchor body, the hair implant comprises a plurality of hair strands, the first inner hair capsule includes a retained portion of at least the first of the hair strands, and the second inner hair capsule comprises the retained portion of at least the second of the hair strands .

[00119] In certain embodiments of the hair implant, the anchor body comprises a first inner hair capsule and a second inner hair capsule, at least one collagen-receiving structure includes an outer surface of the anchor body having a thread spirally enclosing the anchor body, the hair implant comprises a plurality of strands of hair , the first inner hair capsule encloses the retained portion of at least the first of the hair strands, and the second inner hair capsule encloses the retained portion of at least the second of the hair strands.

[00120] In certain embodiments of the hair implant, the anchor body is cuboid, the anchor body includes at least four internal hair capsules, each containing a retained portion of at least one hair, at least one collagen-receiving structure includes at least one channel extending lengthwise between the hair capsules and at least one channel extending widthwise between the hair capsules, and there are no hairs in the channels.

[00121] In certain embodiments of the hair implant, the anchor body is egg-shaped, the anchor body comprises more than two internal hair capsules, at least one collagen-receiving structure comprises at least one channel located at the proximal end of the anchor body, at least At least one canal is free of hair and the hair implant contains a plurality of strands of hair with their preserved parts enclosed in hair capsules.

[00122] In certain embodiments of a hair implant, at least one collagen-receiving structure comprises at least one closed channel and at least one open channel that extend parallel through the anchor body along a central longitudinal axis, and in which 1-5 strands of hair are located at the distal end of the hair implant.

[00123] An eleventh aspect of the invention is a method for restoring hair, comprising: (1) forming an incision in the skin; (2) inserting the implant of the invention into the incision so that 0.1-2 mm of silicone coating at the proximal end of each of at least two strands of hair remains: (a) outside the skin, (b) above the epidermis, (c ) under the skin or (d) under the epidermis; and (3) applying an adhesive to the incision.

[00124] In certain embodiments of the hair restoration method, the incision is made to a depth of 2-8 mm.

[00125] In certain embodiments of the hair restoration method, the adhesive is cyanoacrylate.

[00126] In certain embodiments of the hair restoration method, collagen penetrates the channels of the anchor to form ligatures that bind the implant.

[00127] In certain embodiments of the hair restoration method, the implant is inserted into the incision such that 0.1-2 mm of the silicone coating at the proximal end of each of the at least two strands of hair remains outside the skin or above the epidermis.

[00128] In certain embodiments of the hair restoration method, the implant is inserted into the incision such that 0.1-2 mm of the silicone coating at the proximal end of each of the at least two strands of hair remains under the skin or under the epidermis.

BRIEF DESCRIPTION OF MULTIPLE DRAWING TYPES

[00129] The invention will be described in conjunction with the following drawings, in which like reference numerals denote like elements and where:

[00130] Fig. 1 is a front perspective view of an embodiment of an implant of the invention;

[00131] Fig. 2a, 2b and 2c are front views of three other embodiments of an implant of the invention;

[00132] Fig. 3a, 3b, 3c and 3d are front views of four embodiments of the anchors of the invention;

[00133] Fig. 4a, 4b and 4c are front views of three other embodiments of the anchors of the invention;

[00134] Fig. 5a, 5b, 5c and 5d are front views of four other embodiments of the anchors of the invention;

[00135] Fig. 6a, 6b, 6c and 6d are front views of four other embodiments of the implants of the invention;

[00136] Fig. 7 is a front view of another embodiment of the anchor of the invention;

[00137] Fig. 8 is a schematic top view of an embodiment of the invention in which the implants are inserted into the scalp of a patient at a constant distance from each other defined by a grid;

[00138] Fig. 9 is a front perspective view of another embodiment of the anchor of the invention;

[00139] Fig. 10a and 10b are front perspective views of further embodiments of an implant of the invention;

[00140] Fig. 11 is a front perspective view of another embodiment of an implant of the invention;

[00141] Fig. 12 is a schematic view of a scalp not in need of hair implantation;

[00142] Fig. 13 is a schematic cross-section of the skin showing the natural anatomy of the hair follicles and follicular junctions;

[00143] Fig. 14a, 14b, 14c, 14d - views of the present invention and prior art inventions for comparison;

[00144] Fig. 15a is a perspective view of another embodiment of an implant anchor using a single central inner hair capsule and two proximal ends;

[00145] Fig. 15b is a top view of the implementation in fig. 15a;

[00146] Fig. 15c is a cross section of the implant anchor in fig. 15a taken along the line 15c-15c in fig. 15b;

[00147] Fig. 15d is a bottom view of the implant anchor in fig. 15a taken along the line 15d - 15d in Fig. 15a;

[00148] Fig. 15e is a side view of the implant anchor in fig. 15a showing a strand of hair located in the inner channel;

[00149] Fig. 16a is a perspective view of another embodiment of an implant anchor using a single central inner hair capsule and a single proximal end;

[00150] Fig. 16b is a top view of the implementation in fig. 16a;

[00151] Fig. 16c is a cross-sectional view of the implant anchor in fig. 16a taken along the line 16c-16c in fig. 16b;

[00152] Fig. 16d is a side view of the implant anchor in fig. 16a;

[00153] Fig. 17a is a perspective view of another embodiment of an implant anchor having three closed channels and corresponding open channels at its proximal and distal ends;

[00154] Fig. 17b is a top view of the implant in fig. 17a;

[00155] Fig. 17c is a cross-sectional view of the implant taken along line 17c - 17c in fig. 17b;

[00156] Fig. 17d is a cross-sectional view of the implant taken along the line 17d - 17d in fig. 17b;

[00157] Fig. 18 is a perspective view of a further embodiment of an implant anchor of the invention having two hair capsules and a plurality of closed channels, but no open channels;

[00158] Fig. 19 is a perspective view of another embodiment of the implant anchor of the invention having a tree shape with upward projections;

[00159] Fig. 20 is a perspective view of another embodiment of the anchor of the invention having a tree shape with transverse projections;

[00160] Fig. 21 is a perspective view of another embodiment of the anchor of the invention having a tree shape with projections pointing downwards;

[00161] Fig. 22a is a front view of another embodiment of the cruciform implant anchor of the invention;

[00162] Fig. 226 is a partial perspective view of the implant anchor of FIG. 22a, taken along the line 22b - 22b in Fig. 22a;

[00163] Fig. 23 is a front view of another embodiment of an inverted Y-shaped anchor of the invention;

[00164] Fig. 24 is a perspective view of another embodiment of an anchor of the present invention having a toothed shape;

[00165] Fig. 25 is a perspective view of another embodiment of an anchor of the present invention having a plurality of cup structures along the anchor body;

[00166] Fig. 26 is a perspective view of another embodiment of an anchor of the present invention having a helical or helical structure around the anchor body;

[00167] Fig. 27 is a perspective view of another embodiment of the racket-shaped anchor of the invention;

[00168] Fig. 28 is a perspective view of another embodiment of the bar-shaped anchor of the invention;

[00169] Fig. 29 is a front view of another embodiment of an egg-shaped anchor of the present invention;

[00170] Fig. 30 is a front view of an embodiment of a one-piece implant of the invention in which the hair element and the anchor body are made of the same material;

[00171] Fig. 31 is a front view of another embodiment of a one-piece implant of the invention, in which the hair elements and the anchor body are made of the same material.

[00172] Fig. 32 is a front view of another embodiment of an implant of the invention in which a plurality of hair elements form or are attached to a styled hair tuft structure.

[00173] Fig. 33 is a front view of another embodiment of a one-piece implant of the invention, in which accessory hair elements and additional hair growth structures protrude from the sides of the main hair elements.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[00174] The goal of implanting artificial hair into the human body is to achieve a natural appearance with minimal or no side effects. The implantation of artificial hair according to the invention achieves this goal by providing a practical and safe option for the patient to restore hair loss, which will meet and exceed the expectations of patients who want additional hair not only on the head, but on any part of the body, including . on the face, limbs, trunk and pubic region, without adverse effects from previous and existing methods.

[00175] Observation of the natural shape of existing living hair follicles and their anatomy has provided valuable information regarding preferred structural and functional elements for artificial hair implant materials, design and placement techniques.

[00176] Natural hair appears prominently at the exit of the skin from the deeper layer of the skin. This is a very important observation (57, 86). If you study hair braiding, hair extensions or similar hair systems, there hair comes out from under the skin and often looks not only unnatural, but also does not correspond to the natural color or density of hair that occurs with natural hair growth on the sides and back of the head. Upon closer examination of these hair systems, one can see the artificial framework to which the hair is attached. In addition, the hair system requires some type of fixation of this base to the skin, such as tape, adhesive or some kind of clip. Such a system is like wearing a thick woolen hat, which can sometimes be uncomfortable due to heat, sweat, and irritation.

[00177] The natural anatomical thickness and structure of the hair will vary depending on the age and sex of the individual, as well as their genetics. A very natural and thick hair look can be achieved with hair implantation because, unlike hair transplant surgery, there is an unlimited amount of hair available for implantation. Hair implants can be mass-produced as opposed to limited access to natural living hair follicles. Desired hair density results are also achieved through the use of a smooth and narrow implant design that will allow hair implants to be placed close or closer to each other in addition to the ability to add nascent hairs (auxiliary hair and hair growth elements described below) to increase volume. The design of a hair implant preferably mimics the overall size and shape of a natural hair follicle (31, 32). This issue of hair density becomes critical for women and young men, because in the vast majority of cases, the density in the scalp area is very dense, with no signs of shedding or bald patches along the hairline. Any type of hair restoration, whether medical, surgical or non-pharmacological, that results in low hair density will result in a sub-optimal appearance for such patients and, as a result, disappointment and low self-esteem.

[00178] Drug treatment, including minoxidil or finasteride, is not capable of such success. The hair transplant operation cannot achieve the target density due to the limited amount of "live" hair to be transplanted from the donor area, and the planting of live hair grafts too close together leads to damage and death of the hair follicles. Even with the best medical and surgical efforts, a natural head hair density of 80–90 follicular units per square centimeter cannot be achieved (55). Artificial hair such as wigs, weaves, extensions, etc. can achieve the desired hair density and pattern, but these systems are too unnatural looking and very uncomfortable because lead to heat, sweating, as well as irritation and inflammation of the skin, traction alopecia, leading to further natural hair loss (90-93).

[00179] Cells in the body, including skin cells, have natural attachments to each other. These attachments provide not only communication channels, but also protect the body from the penetration of bacteria. These attachment mechanisms, also called tight junctions or desmosomes (33-37), provide anchorage to the hair follicle, protection from invading bacteria, and protection from immune system cells approaching or making contact with the hair fiber itself.

[00180] The natural flora or microbiological organisms of the skin are numerous. These microorganisms are mostly harmless and provide the immune system with the benefits of interacting and helping to help protect the body. However, these "living spaces" are limited by the natural physical barriers present in the skin. Structural anchoring and physical barrier mechanisms of the skin, including the hair follicle and its close connection to the surrounding skin, glandular elements and desmosomal cellular junctions between cells and the natural collagen layer surrounding the follicles, restrict the natural skin flora from penetrating into the deeper layers of the skin and circulation (39 , 40, 41). The natural flora changes under certain circumstances, such as when hair loss occurs. If there is a loss of the hair follicle, and there is no longer its anatomical structure penetrating deep into the skin, then the normal flora will no longer live there. When a hair implant is placed, this follicular anatomy will be recreated and the bacteria will again live in the skin surface. When a hair implant forms an outer collagen sheath (or a collagen sheath from a foreign body reaction), then a channel (or small distance) between the implant and the collagen will exist at a certain distance on the distal side, which to some extent will mimic the natural follicular anatomy with its natural flora. . With the formation of the collagen sheath, there will be a strong physical barrier to prevent bacterial penetration into the deeper layers of the skin and into the blood or lymphatic circulation. This type of collagen barrier is the same barrier that occurs in the normal anatomy and histology of the natural hair follicle (32).

[00181] Natural hair fibers are known to be antigenic, highly reactive, and highly inflammatory when exposed to the immune system. The collagen sheath surrounding the natural hair follicle prevents the immune system from “seeing” and attacking or killing the living organ of the hair follicle (30, 42, 43, 44). When a hair or hair follicle is out of place, but outside of its natural shell, such as in the case of ingrown hairs, the hair interferes with the immune system. Ingrown hairs cause a giant cell foreign body reaction (cells involved in the foreign body reaction), causing the immune system to attempt to encapsulate the hair or hair particles with collagen (45, 46). This is the same reaction that will be used positively to guide and form the collagen sheath around the hair implant of the present invention.

[00182] In humans, there are about 100 thousand hairs on the scalp, and about 5 million on the body. About 120 square inches on the scalp 64 is skin with hair 28. Each square inch (or 6.4 square centimeters) is made up of 833 hairs, i.e. There are about 130 hairs per square centimeter. See fig. 12.

[00183] Hair loss is not perceived or observed until about 50% is lost. The ultimate goal in hair restoration is to achieve the appearance of a full head of hair, which can be achieved by providing only 50% of the normal amount of hair per unit area. The present invention can provide a full head of hair, or a somewhat smaller head of hair for those whose hair restoration goals are more moderate.

[00184] Assuming complete hair loss from the human head, replacing 50% of the original amount would require implantation of 65 hairs per square centimeter. The present invention preferably allows up to 65 or up to 100 hairs per square centimeter to be implanted. In embodiments of the invention containing nascent hairs, the density of the hairline can vary up to about 200 hairs per square centimeter. This is more than the required 65 hairs, but allows for hair loss over time. The added density will maintain the appearance of a thick head of hair for a longer period of time between hair implantation sessions.

[00185] When examining the scalp, it will be noted that most hair follicles naturally cluster close together and generally do not separate into individual hair follicles. These natural groups are called "follicular junctions". As shown in fig. 13, follicular connections 60 typically include 1, 2, 3, or 4 hairs 28. See (52). Hair 28 grows from follicle 62 into dermis 58 and exits into epidermis 56. This aspect of the natural anatomy was taken into account in the design and manufacture of artificial hair implants.

[00186] The density and depth of hair follicles in the skin is also observed. Surgical photographs demonstrate the depth and density of hair follicles (26, 54, 55).

[00187] In addition to these key anatomical observations of the natural hair follicle, there are other functional elements such as sensory nerves, blood vessels that nourish the hair follicle, sebaceous and other glandular elements involved in certain fluid secretions that are associated with the natural living hair follicle. . The absence of such functional elements in artificial hair implants does not preclude the achievement of the goals of a very natural feel and appearance of the hair.

[00188] Thus, in a natural anatomical design, there are several features that can be replicated in an artificial design to achieve the patient's goals of obtaining a complete or near complete complement of hair that feels and looks natural. The artificial implants of the present invention preferably provide one or more of the following: (1) a natural appearance of the hair emerging from the scalp, (2) the natural thickness and texture of the hair, (3) a suitable anchorage of the hair implant to prevent unwanted hair loss, and (4) protecting the artificial hair implant from the immune system and preventing inflammation in the short and long term.

[00189] Hair Implantation: Structure, Function and New Innovative Considerations

[00190] MATERIALS

[00191] Introduction

[00192] Medical grade silicone rubber and similar materials have been used in cosmetic and medical applications for decades as key components of implantable medical devices. Over the past few decades, these materials have been used by millions of people to improve the face, chest, and other parts of the body. These implants have proven to be safe for permanent implantation in the body. Although safe, it is recognized that there is a possibility that such implants may need to be replaced in the future over time. Replacement of implants is indicated, for example, in the case of long-standing, deformed or ruptured silicone breast implants (and other cosmetic implants) when severe contractures, pain, psychological problems or an aggressive foreign body reaction with a collagen encapsulated medical device occur. (66-70, 73-75).

[00193] The anchor portion of the implant, with or without any assistance or the need for additional chemical coating to ensure durability, will be in direct contact with the body and the immune system. This material will cause a foreign body reaction. A foreign body reaction will cause the implant to become occluded or encapsulated by collagen. This reaction will continue until the entire implant is surrounded by collagen. This enveloping of collagen around the implant is advantageous for many reasons. First, a full collagen sheath around the implant will protect the immune system from the implant itself, which is the goal of a foreign body reaction to any foreign body. Second, the collagen will form a chemical bond directly with the implant material, resulting in anchoring or fixation of the implant. Thirdly, the formation of collagen will decrease over time, which will give additional fixation and stabilization of the implant along the concave sides of the implant. Lastly, and most importantly, this collagen sheath is naturally present in the normal anatomy of the hair follicle, which provides a natural collagen barrier to the highly antigenic hair follicle from the immune system, and thus would provide the same function for a hair implant.

[00194] A foreign body reaction is the body's reaction to an invading or entering foreign body, such as a piece of metal, plastic, or a foreign substance. The ultimate goal of this reaction is to protect the body by quarantining or encapsulating the foreign substance with collagen, and thereby harboring and subsequently making this substance harmless to the body. Once this immune system reaction is completed, this encapsulation reaction will also stop.

[00195] Considering that the reaction of the immune system to a foreign body leads to collagen encapsulation, this mechanism can be used in a special way in relation to the healing process and fixation of the hair implant. This reaction can help produce collagen in a controlled and precise way. The desired goals are to surround and form a collagen sheath around the hair implant, to provide antibacterial protection, to provide the essential anchoring properties necessary for the stability and success of hair implantation, and to protect the implant from further immune system responses such as chronic inflammation, etc. .d. Foreign body response and sequence of events will be discussed below.

[00196] After the installation of hair implants, the body will see that a foreign body has been introduced into it. The silicone-tipped or anchored hair implant itself will be in open or direct contact with the body. This direct contact will trigger a very special biochemical reaction of the immune system, the foreign body reaction.

[00197] This reaction of a foreign body is usually considered as a reaction of the final stage of the inflammatory and wound healing process after the implantation of a medical device or prosthesis. The purpose of this particular type of reaction is to shield or isolate this foreign substance in an attempt to protect the body. This reaction, which is very different from the reaction of white blood cells to a bacterial infection, consists of very special cells called macrophages and foreign body giant cells. These cells set off an inflammatory response leading to the formation of collagen, which will eventually completely surround or wall off the foreign body if possible, essentially enclosing it in collagen and making it safe or harmless to the body in the body. It also brings the immune system to a dormant state.

[00198] This collagen sheath formed around the implant will prevent a chronic inflammatory response by completely protecting it from the immune system. Such a reaction to a hair implant is highly desirable.

[00199] In addition, the formation of collagen will help to attach the hair implant to the skin through a combination of biochemical reactions and physical interactions. The biochemical reaction is the direct attachment of collagen to the silicone material.

[00200] There is also a physical interaction between the newly formed collagen and the hair implant anchor. Given that, in certain embodiments, the anchor has a concave shape, the collagen will hug or tighten around the anchor, preventing it from being released from the skin. Channels are another physical characteristic of the anchor. These channels will allow collagen to enter the anchor, forming a collagen loop that will help bind the implant to the living biological ligature. Biological collagen ligatures will be one of the main mechanisms by which the anchor is held. If the anchor were to break along the fracture line, which is what it is intended for, if the anchor is heavily worn or overstressed, the collagen ligatures will come loose, causing the two parts of the anchor to become unstable. This destabilization allows the anchor to be easily released, thereby preventing the anchor fragment from becoming stuck in the body.

[00201] Finally, the combination of the progressively enveloping collagen and the direct physical attachment action results in the anchoring of the collagen around the anchor, which provides an additional protective function by preventing bacteria from penetrating between the anchor and the collagen sheath due to the space restriction formed there. Now that the foreign body (anchor) is sealed with collagen, the body's immune system has fulfilled its protective function and will allow this sealed substance to remain in the body for the rest of life without subsequent acute or chronic inflammatory reactions.

[00202] It is important to note that natural hair follicles also have a collagen sheath, which is a very important and interesting parallel not only to mention but also to mimic. The protective collagen sheath that forms around the hair follicle can be seen as the natural hair fibers develop embryologically. And this is not accidental, but by design, because without this outer collagen shell, the body would attack the hair follicle, considering it a foreign body, and would destroy it.

[00203] Thus, the foreign body response is exploited to fulfill many of the aforementioned functions and purposes in hair implantation, including fixation and strength of the hair implant, prevention of infection, lack of immune response, elimination of chronic inflammatory conditions, and prevention of subsequent pain, discomfort and scarring.

[00204] Natural look

[00205] Obtaining a natural appearance of hair emerging from the skin at the epidermal level can be achieved by using natural (or synthetic) hair fibers and implanting these fibers in such a way that the anatomy of the epidermal junction of a normal hair fiber is imitated (without ulceration or unusual anatomical deviations). The materials needed to achieve this goal are natural looking strands of hair, natural or synthetic, and, for ease of discussion, silicone rubber to cover the tip of the hair. The part of the hair tip covered with silicone rubber will be in direct contact with the skin or will be implanted into it. The main condition for the natural appearance of hair emerging from the scalp or any areas of skin with hair is closely related to the type of incision made (discussed in the Implant Technique section) and the shape of the silicone implant at the epidermal level (discussed in the design section).

[00206] A strand of hair, whether natural or artificial, can be matched in color, shape, length, and so on. depending on the anatomical location and cosmetic wishes and needs of the patient. For example, scalp hair implants can be custom made long, short, straight, curly, dark or light, etc. Hair implants can also be adapted to the eyebrows, pubis and other areas. See, for example, Otberg et al. (58).

[00207] In embodiments where the hair component, whether natural or synthetic, will be coated with another material and then implanted into the skin, the type of hair used is not critical as the hair is not visible to the body or immune system. Only the coating on the hair will be in direct contact with the skin and subcutaneous tissues or the immune system. This cover material of choice, such as medical grade silicone (or other or combined materials such as an optional outer layer of polycarbonate), will be in direct contact with the skin and the immune system and thus not only biochemically bind, physically hold, play a role ligature anchor, stabilize the implant, but also reduce the oxidation reaction when trying to maintain the integrity of the implant in the long term in the event of failure.

[00208] Suitable materials for the hair component of the implant of the invention include, but are not limited to, human hair, animal hair, and synthetic polymers. Non-limiting examples of polymers suitable for synthetic hair include one or more of polypropylene, polyvinyl chloride, polyamide, polyethylene, polyacrylonitrile, polyvinylidene chloride, polyurethane, and polyester.

[00209] Hair suitable for use in the present invention may be straight, tightly curled, or lightly curled. Suitable hair can be dyed, partly dyed or undyed. The length of the hair fibers is not particularly limited, but suitable hair fibers are preferably at least 5 cm or at least 10 cm or at least 15 cm in length for ease of styling after implantation. Hair materials suitable for use in the present invention preferably have a diameter similar to natural hair, for example in the range of 0.02 to 0.2 mm. The cross-sectional shape of the hair is preferably elliptical or round, as in natural hair.

[00210] Density and pattern of hair

[00211] The anchor preferably has a very narrow design that mimics the actual size of a natural hair follicle, which allows close placement or approximation of hair implants, providing a high density of hair per unit area. The anchor preferably has significant material strength and durability to withstand pulling forces and oxidation reactions from the immune system.

[00212] Fixing the hair implant

[00213] The implant anchor composition of the present invention plays an important role in anchoring the hair implant; however, there are other important factors associated with anchorage, such as the shape and internal structure of the implant, which will be discussed in the design section. The material of the implant makes it possible to stimulate the appearance of a reaction of a foreign body, as a result of which a collagen shell is formed directly around the implant. This tight bond will then lead to a biochemical bond between the collagen and the base (i.e. the anchor). This bond, whether covalent and/or non-covalent, will provide anchor strength. Another factor is that the material promotes the formation of collagen inside and outside the implant. The anchor preferably contains channels (defined here as cavities of various sizes formed to be infiltrated by the tissues of the wearer, which include, but are not limited to, pores, grooves, and channels) so that the reaction of the foreign body and the subsequent formation of collagen can penetrate the anchor and act as a ligature for retention implant in place. The anchor material is preferably a collagen growth promoter to promote this.

[00214] The state of the art in hair implantation states that foreign body reaction is detrimental to implantation and should be prevented. The present invention goes against the prior art by stimulating the appearance of a foreign body reaction and the subsequent formation of a collagen sheath, as well as collagen ligatures through the channels of the implants of the present invention to secure them to the scalp or other tissues.

[00215] For example, Erb et al. (100) states that the goal is to avoid foreign body reactions and rejection reactions, and Laghi (101) states that foreign body reactions are destructive. Moreover, Erb et al. claim tissue growth as a result of a foreign body reaction that is cellular in nature and not collagenous.

[00216] Protection of the hair implant from the immune system

[00217] The anchor material helps protect the hair implant from immune system attack and oxidation by causing a foreign body reaction. The foreign body reaction will allow the body to surround the hair implant with a collagen wall and thus “turn off” the immune system, since the goal and end reaction of the foreign body is to isolate the foreign body, which in this case is the hair implant itself. In addition, a stronger material will resist oxidation from the interaction between the implant material and the body. This oxidative process may come from the immune system or local cells releasing certain chemicals that cause this reaction. Finally, the material preferably allows a linear fracture (or tear) and avoids fragmentation. The material preferably allows a limited risk of breakage into small pieces. References covering other implantation methods, such as Erb (100), Laghi (101) and Keren (87), do not recognize the potential problem of fragmentation, which can lead to fragments stuck in the body and chronic inflammation, and do not offer a solution to this very important problem. Problems.

[00218] Safety Features of Hair Implants

[00219] The materials used in implantable medical devices for medical use have been studied, proven to be safe, and have been used for over 50 years. Of course, their safety has been proven with certain limitations. For example, breast implants typically have a lifespan of about 10 years. Although they are not permanent, they can be removed and then replaced. In a similar vein, hair implants can also last 10 years or more, after which they may fall out naturally or be deliberately removed, i.e. hair implants can also be replaced.

[00220] CONSTRUCTION

[00221] Representation

[00222] The design used for the hair implant of the present invention lies in a certain size, shape and internal structure to optimize certain goals, including to provide secure attachment, bacterial barrier, natural and appropriate hair density and pattern placement, as well as structural the integrity of the implant to prevent its oxidation and destruction.

[00223] Natural looking hair coming out of the scalp

[00224] One of the key design factors for hair implants to look as natural as possible is to carefully study how natural hair exits the skin at the epidermal level. A criterion or goal for hair implant design is that the hair implant emerges from the scalp with a similar or similar epidermal-dermal anatomy to existing hair. Natural hair emerging from the scalp (with all its natural anatomical features) is the ultimate goal for the analogy.

[00225] Natural hair emerging from the epidermis has certain anatomical features, such as a small diameter and a certain angle and depth of the epidermis. These natural anatomical characteristics can be mimicked by applying certain design features to hair implants. For example, by creating the distal end of a hair implant in a tubular shape, with a minimum diameter and an appropriate expansion slope from distal to proximal, the hair implant will allow the epidermal opening diameter and internal slope to be the same or similar to natural hair. Of course, this epidermal development relative to formation will occur during the healing process, which will include foreign body reaction and epidermal migration.

[00226] This natural appearance of hair emerging from the skin is a rare characteristic of most if not all hair restoration solutions. Hair coming out from above the skin in wigs and overlays does not look very natural at all. Hair transplant surgery will cause the hair to come out from under the skin; however, in most cases, the methods used result in damage to the skin, as a result of which the pores of the skin expand and deepen in size, which is often referred to as skin ulceration.

[00227] Density and pattern of hair

[00228] The design of the anchor also has an impact on hair density and pattern, and the shape of the anchor with an overall smooth, narrow design and an angled proximal hair strand will help achieve these goals. A smooth or narrow design, preferably no wider than 300-2500 microns in any particular area, will allow better placement of hair implants per unit area to achieve natural hair density in any hair-bearing zone. In certain embodiments, the anchor is sized to fit a 10 x 10 x 10 mm cube.

[00229] The density and structure of hair differs between men and women, young and old, different races and religions. Hair that looks natural, whether the implants are sparse or close together, can help each patient achieve the desired hair density and pattern. Very thick hair in youth and women can be achieved with a smooth, narrow hair implant design that allows any hair implant to be closely spaced, resulting in natural hair density. Conversely, a less dense hair pattern, if desired, can be reproduced on the scalp in older men.

[00230] Hair pattern is closely related to hair density. The pattern refers to the location of the hair and the angle of their exit from the skin. For example, if an elderly person not only wants to have the appearance of thinning hair, but also wants to have a thinning hairline with a sparse area at the crown, then this can be easily achieved by physically placing hair implants on the desired areas of the skin. The exit angle of the hair is a more important characteristic for the temporal part of the head and the eyebrow area. It is necessary that in these places the implant come out at an angle sharper than that allowed surgically when creating the recipient site. For example, when creating a recipient site, the clinician may only insert the needle/cutting instrument at a certain angle that is not sharp enough. The need for a sharp angle is critical, because if the hair on the eyebrows does not grow parallel to the skin, but up and out, it will look very unnatural. To achieve this sharp angle, the hair component itself will be tilted or curled. The introduction of such a non-linear hair into the silicone part of the implant will provide the additional hair exit angle needed to give the hair a natural look.

[00231] Fixing the hair implant

[00232] Designs, including external and internal forms, will be the most important aspects regarding the anchoring of the hair implant.

[00233] The internal structure consists of one or more channels. The foreign body reaction will produce collagen along all silicone surfaces, including the inner surfaces of the canal. When collagen is formed at channels with silicone surfaces, it will form a natural collagen loop much like a natural anchor suture or ligature to help secure the implant from pulling out.

[00234] The outer structure, which is preferably provided with certain concave areas, will provide anchoring points after collagen has developed around the implant. When the implant is surrounded by collagen, and because there are concave and convex parts, it will take a lot of physical force to pull the hair implant out of the skin due to the additional resistance exerted on the implant by the collagen.

[00235] Another factor to consider is the reduction in collagen that occurs over time. For example, when installing silicone breast implants, the reaction of the foreign body leads to the formation of a collagen sheath around the implant. Over time, this collagen shell will shrink, putting pressure on the breast implants. For breast implants, this is unfavorable as it results in discomfort and pain for the patient; however, it is favorable for hair implants. This force of collagen formation and contracture will help anchor the hair implant. In addition, this contracture force will provide a stronger and stronger barrier between the implant and the skin/subcutaneous area, which will prevent bacteria from entering.

[00236] Protection of the hair implant from the immune system

[00237] Referring to Fig. 1, the anchor 22 of the implant 20 comprises two vertical components (or anchor bodies) 24 connected by a bridge 26 with a closed channel (or cavity) 42 above the bridge and an open channel 44 below the bridge. In this embodiment, which mimics the natural follicular connection with two hairs and two hair follicles, each hair 28 is within an inner hair capsule 30 that has a distal opening 32 and a proximal end wall 38 near the proximal end of the implant 20. The hair 28 emerges from the distal end 34 of the implant 20 through the distal opening 32. In accordance with the preferred embodiment of the invention, at least one hair 28 is located on each side of the fracture line 46 (discussed in more detail below), so that in each of the two fragments resulting from the fracture implant 20, there is at least one hair.

[00238] Anchor 22 measures preferably 2-8 mm or 3-6 mm in length (i.e. along the longitudinal axis defined by the strand or strands of hair within the anchor; from top to bottom in perspective as shown in Figure 1), preferably from 500 µm to 2.5 mm wide (i.e. along an axis transverse to the longitudinal axis; from left to right in perspective as shown in Figure 1) and preferably 500 µm to 2.5 mm deep (i.e. towards the viewer and from the viewer in perspective, as shown in Fig. 1). The dimensions of the anchor are preferably adjusted depending on the location of the hair.

[00239] For example, scalp hair penetrates the skin to a depth of about 6 mm, and eyebrow hair is typically shorter, about 3-4 mm in length. This depth of construction is not only similar to the penetration depth of a natural hair follicle, but provides additional positive safety features. This minimal depth design will allow the body to encapsulate or seal the implant with collagen, hiding it from the immune system, unlike known hair implant systems. In addition, after the immune system completes the formation of collagen through the foreign body reaction, the interaction between the silicone implant and the immune system will cease. This is not the case with the known hair implantation technique, which exposes a relatively long piece of highly antigenic hair (whether natural or synthetic) to the immune system by placing the hair deep into the scalp and tying or connecting the hair to the deep scalp fascia, the supracranial aponeurosis. This prior art system leads to a state of chronic inflammation with further consequences such as infection, scarring, granuloma formation and pain. It has been proven that collagen enveloping such a long hair implant, with a knot at the end, and hair passing through several levels of tissue, cannot cope with complete encapsulation by collagen. Without complete collagen encapsulation of the hair implant, the foreign body reaction will continue indefinitely, preventing the immune system from shutting down or remaining dormant.

[00240] Safety Features of Hair Implants

[00241] There are two main problems associated with the safety of hair implantation, infection and inflammation.

[00242] Infection is caused by living organisms such as bacteria, fungi and viruses. Living organisms naturally live on the surface of the skin and in symbiosis (in most cases). If the anatomy of the skin changes, such as in a cut of the skin, then these bacteria can now enter the body and cause an infection. Hair implantation will involve a temporary small puncture with a needle, then a hair implant is placed in this puncture, after which healing will occur. It is important that healing occurs, and infection and inflammation do not occur.

[00243] Hair implants should be shaped to prevent the downward flow of microorganisms around the hair implant, thereby preventing infection. Prevention of infection is carried out through the internal and external shape of the hair implant, the reaction of the foreign body and the production of the collagen sheath, the contraction of the collagen sheath over time, the biochemical binding reaction between the collagen-silicone rubber surface, the distal structure and the cleanliness of the patient's hair and scalp. Such design features may be present in the natural anatomy of the hair follicle: collagen sheath, biochemical bonds at cell junctions and tight junctions, and distal constriction.

[00244] The external shape, in particular the narrowing of the distal end, will result in a minimal epidermal opening, thus limiting the size of the passage and exposure to bacteria at the points of contact of the hair implant with the skin. In certain embodiments, there will be a distal initial upward and then downward oblique angulation of the article, tilted upwards by 30-45 degrees, which will prevent an easy downward flow path for bacteria. Growth of epithelial cells that will form along the distal end of the implant and adhere to the newly formed collagen sheath will provide additional cell contact and proximity to the implant, thus limiting access to bacteria.

[00245] The general attachment aspects, which include the outer and inner shape of the hair implant, also support the bacterial entry barrier by forming a tight fit between the implant and living tissue that prevents bacterial entry.

[00246] The cross-sectional shape of the anchor and its subcomponents is round or oval in certain embodiments of the invention.

[00247] In certain embodiments, the anchors are in the general shape of the letters of the alphabet. These embodiments (collectively referred to as "alphabetic anchors") are identified here with the term "anchor" and the letter most similar in shape to the anchor (eg, anchor A, anchor H, anchor W, and anchor V). There will be some changes in the anchors corresponding to the designated letter, but the overall shape of the designated letter will still be apparent. Each alphabetic anchor contains at least one channel and at least one jumper.

[00248] Preferred anchor A options are shown in Fig. 3a, 3b, 3c, and 3d. Each option includes two vertical components (or anchor bodies) 24 connected by at least one web 26 and additionally includes one open channel (or cavity) 44. Embodiments differ depending on the number of closed channels available. The embodiment in fig. 3a has one closed channel 42, the embodiment in fig. 36 does not have a closed channel, the embodiment in fig. 3c has two closed channels 42, and the embodiment in fig. 3d has three closed channels 42. The channels are mainly located in the center along the fracture line of the anchors.

[00249] Preferred embodiments of anchor H are shown in FIG. 4a, 4b, and 4c. Each option includes two vertical components 24 connected by at least one jumper 26, and additionally includes two open channels 44 of substantially the same size. Embodiments differ depending on the number of closed channels available. The embodiment in fig. 4a does not have a closed channel, the embodiment in fig. 46 has one closed channel 42, and the embodiment in fig. 4c has two closed channels 42. The channels are generally centrally located along the fracture line of the anchors.

[00250] Preferred embodiments of the W anchor are shown in FIG. 5a, 5b, 5c, and 5d. Each option includes two vertical components 24 diverging from each other in the distal direction, which are connected by at least one bridge 26 and additionally include at least one open channel 44. The embodiment in Fig. 5a has no closed channels and two open channels 44, the embodiment in fig. 5b has one closed channel 42 and two open channels 44, the embodiment in fig. 5c has two closed channels 42 and two open channels 44, and the embodiment in fig. 5g has one open channel 44 and no closed channel. The channels are substantially centrally located along the anchor's fracture line.

[00251] Each anchor (alphabetic or otherwise) preferably has two vertical components, at least one horizontal component, and at least one channel.

[00252] The vertical component is the part of the anchor that will contain the hair. [00253] A horizontal component, also referred to as a "bridge", will be the attachment point connecting adjacent vertical components. The webs preferably have a length of 100 µm to 4 mm and a diameter of 100 µm to 4 mm. The number of bridges that exist that connect the vertical components is related to the number and type of channels formed.

[00254] The dimensions of the channels preferably range from 100 µm to 6 mm in length and from 100 µm to 2 mm in diameter.

[00255] Referring to the embodiments of FIG. 2a and 2b, each vertical component 24 comprises an inner hair capsule 30 having a distal opening 32 at the distal end 34 of the anchor 22. The inner hair capsule 30 preferably has a diameter of 25-250 microns.

[00256] The embodiment in FIG. 2a has a knot capsule 48 at the proximal end of each inner hair capsule 30. Each knot capsule 48 has a larger diameter than the corresponding inner hair capsule 30 such that a knot 50 having a larger diameter than that of the inner hair capsule 30 is held within the knot capsule and thereby anchoring the hair 28 to the anchor 22. The size of the knot capsule is preferably 500 µm to 6 mm in length and 100-750 or 100-500 µm in diameter.

[00257] The embodiment in FIG. 2b has a proximal opening 36 at the proximal end 40 of each inner hair capsule 30.

[00258] Within the scope of the present invention, for each proximal end of each inner hair capsule within the anchor, there is an independently selected end from the group consisting of a nodal capsule, a proximal opening, and a proximal end wall. Preferably, each proximal end of each inner hair capsule within the anchor has the same type of end (eg, two knot capsules, two proximal holes, or two proximal end walls). In certain embodiments, at least one distal opening 32 and/or at least one proximal opening 36 is tapered and flares outwards.

[00259] In Fig. 2c shows a "loop" inner hair capsule 30 that extends from one vertical component 24 through a web 26 to another vertical component 24. One hair 28 enters the inner hair capsule 30 at one distal opening 32 and exits the capsule at the other distal opening. 32. Placement of the hair 28 preferably includes inserting one strand into one distal opening 32 and pushing it through the loop of the inner hair capsule and then withdrawing from the other distal opening 32 until the visible portions of the hair differ in length by more than 12 mm. A small amount of adhesive is then applied to the longer visible section of hair just above the distal opening and the adhesive-bearing hair segment is pulled into the inner hair capsule (about 12 mm) such that hairs of substantially equal length are visible. The glue is allowed to cure, which helps to stabilize or anchor the hair in the inner hair capsule.

[00260] Each vertical component preferably has a round or oval cross-sectional shape. Adjacent vertical components may combine with webs to form a variety of suitable shapes, including the alphabetic characters discussed above. Thus, for example, adjacent vertical components may be parallel to each other and, in combination with the web, form an "H" shape. Alternatively, adjacent vertical components may be tilted relative to each other such that they diverge distally to create a "W" or "V" shape. An "A" shaped anchor can be formed when adjacent vertical components are tilted relative to each other so that they diverge in the proximal direction.

[00261] The vertical components and their bridges form channels. A channel is said to be "open" if it is not completely closed along its length, and "closed" if it is only open at its ends.

[00262] The outer surface of the anchor need not be perfectly smooth or linear. Non-limiting examples of external surface variations within the scope of the invention are illustrated in FIG. 6a - 6d in the implementation of the anchor option A. External surface options within the scope of the invention include, but are not limited to, a vertical component, a distal ascending and then a downward slope or only a downward slope (bump 66), a vertical component, a concavity of the average section 52, a vertical component, flaring from distal to proximal (most evident in Fig. 6a), the vertical component of the proximal bulbous shape 54, and rounded corners on all sides of the anchor.

[00263] Open channels 44 are further examples of the outer surface. Open and closed channels facilitate evenness of the fracture of the implant, resulting in two parts, each of which includes at least one hair. The open channels preferably have a length of 0.5-7.5 mm or 1-5 mm and a depth of 50 µm to 5 mm or 100 µm to 2 mm.

[00264] In certain embodiments, the implementation of the anchor may have an external concavity 52, located in the middle longitudinal region on both sides (Fig. 66).

[00265] In Fig. 7 shows an embodiment including concavity 52 and roughness 66. Concavity 52 and roughness 66 may be described by a circle diameter and arc degrees. The circle diameter preferably ranges from 100 μm to 75 mm or from 1 mm to 50 mm, and the arc size preferably ranges from 1 degree to 180 degrees.

[00266] In Fig. 10a and 106 show alternative embodiments of an implant 20 having concavities 52 located in the medial longitudinal region on both sides, undulations 66 at the distal end of the anchor 22, and three or four hairs 28. Preferably, each vertical component 24 contains only one inner hairline. capsule 30 regardless of the amount of hair in it, so that the implant 20 has two internal hair capsules 30, one on each side of the fracture line (excluding the curled hair embodiment described above and shown in Fig. 2c).

[00267] In Fig. 9 depicts yet another external surface in which a circular recess 68 is formed at the distal end 34 of the anchor 22 between the distal holes 32. The circular recess 68 is preferably a distal sagittal median U-shaped recess that will not follow a circle and arc pattern.

[00268] In Fig. 11 shows another embodiment of the implant of the invention, which includes two vertical components 24 connected by bridges 26 and one closed channel 42.

[00269] In Fig. 15a - 15e and 16a - 16d depict additional embodiments of the implant anchor 20, which includes one inner hair capsule 30 and two proximal ends 40a/40b (Fig. 15a - 15e) or one proximal end 40 (Fig. 16a - 16d) .

[00270] As shown most clearly in FIG. 15a and 15c, the implant anchor 20 comprises a single anchor body 24 having a central inner hair capsule 30. The lower end of the anchor body 24 has an open channel 44, thus forming two proximal ends 40a and 40b on the anchor body 24. Near the bridge 26 connecting the two proximal ends 40a/40b at the closed end of the open channel 44, are the corresponding closed parallel channels 42a and 42b. As can be seen most clearly in Fig. 15b, the outer front and rear surfaces of the anchor 20 contain the corresponding connecting surfaces 27a and 27b between the sides of the anchor body 24. In fig. 15d shows two rounded proximal ends 40a and 40b, and in Fig. 15e shows a single hair strand 28 located within the central inner hair capsule 30 and protruding from the distal opening 32 at the distal end 34.

[00271] Fig. 16a-16d show an implant anchor 20 which also uses a single inner hair capsule 30 but which contains a single proximal end 40. As most clearly illustrated in FIG. 16a and 16c, the proximal end 40 contains one closed channel 42. In fig. 16c shows a single strand of hair 28 located in a central inner hair capsule 30 and projecting from a distal opening 32 at the distal end 34.

[00272] Consistent with all other implementations of the implant anchor, the anchor options described in FIG. 15a-15e and 16a-16d contain similar materials and use open and closed channels to support collagen ligature growth after subcutaneous implantation to obtain and retain collagen ligatures capable of anchoring a hair strand anchor to a hair implant recipient. As with all other channeled implant attachment options, open and/or closed channels can also define a fracture line, as described above.

[00273] In Fig. 17a-17d depict a further embodiment of the implant anchor 20 which uses a pair of inner hair capsules 30 and a plurality of closed parallel channels 42 with open parallel channels at the distal end 34 and proximal end 40. In particular, the implant anchor 20 in FIG. 17a and 17b contains a plurality of closed channels 42 (for example, three closed channels), each of which is separated by a bridge 26 and vertically aligned along the central part of the anchor body 24. An open channel 44 is provided at the distal end 34 and at the proximal end 40. The bridges 26 have an oval shape, as shown most clearly in Fig. 17y. As seen in fig. 17c, on each side of the longitudinal axis of the anchor body is a hair capsule 30 oriented vertically, and each capsule 30 has a distal opening 32 at one end and a proximal end wall 38 at the other end; these vertically oriented capsules 30 are parallel to the vertical side walls shown in fig. 17th century These vertically oriented hair capsules 30 are also referred to as "straight" capsules because if their centerlines are lengthened, they will not cross.

[00274] In accordance with all other embodiments of the implant anchor, the anchor embodiment described in FIG. 17a-17d contains similar materials and uses closed channels to support collagen ligature growth after subcutaneous implantation to obtain and retain collagen ligatures that are capable of anchoring a hair strand anchor to a hair implant recipient. As with all other channeled implant anchor embodiments, open and/or closed channels can also define a fracture line, as described above.

[00275] In Fig. 18 depicts a further embodiment of an implant anchor 20 that uses a pair of inner hair capsules 30 and a plurality of closed parallel channels 42, but no open channels at either the distal end 34 or the proximal end 40. In particular, the implant anchor 20 in FIG. 18 contains a plurality of closed channels 42 (for example, five closed channels), each of which is separated by a bridge 26 and vertically aligned along the central part of the anchor body 24. On each side of the longitudinal axis of the anchor body is a hair capsule 30, which is parallel to the side of the hair implant 20, and each channel 30 has a distal opening 32 at one end and a proximal end wall 38 at the other end. These hair capsules 30 are also referred to as "crossover" capsules, since if their centerlines were extended, they would cross. By way of example only, the top three closed channels may be identical in size (e.g., 100 µm wide and 200 µm long), while the bottom two channels are larger, for example, the fourth closed channel 42 from the top may be larger. (eg 200 µm wide and 400 µm long), while the bottommost closed channel 42 may be even larger (eg 300 µm wide and 500 µm long).

[00276] Because the distal end 34 of the implant anchor is smaller than the proximal end 40 of the implant, the sides of the body of the anchor 24 are not vertical, but rather diverge or taper outward from the top (i.e., the distal end 34) to the bottom (t .e. to the proximal end 40). Thus, the sides of the anchor body are "slanted" or "tapered". The hair capsules 30 are parallel to these sides and therefore "intersect" as described above.

[00277] In accordance with all other embodiments of the implant anchor, the anchor embodiment described in FIG. 18 contains similar materials and uses closed channels to support collagen ligature growth after subcutaneous implantation to obtain and retain collagen ligatures that are capable of anchoring a hair strand anchor to a hair implant recipient. As with all other channeled implant anchor embodiments, open and/or closed channels can also define a fracture line, as described above.

[00278] In Fig. 19 shows another embodiment of an implant anchor 20 that uses a pair of inner hair capsules 30 and a plurality of anchor lugs 70 pointing upwards. In particular, the protrusions 70 protrude along the entire length of the vertical body of the anchor 24 and protrude upward at an angle to the distal end 34, like branches on a tree. The protrusions 70 assist in anchoring the hair strand anchor in the scalp of the hair implant recipient. The anchor has a closed channel 42, but no open channels at the distal end 34 and proximal end 40. As in all other embodiments of the invention shown in the drawings, channels, ledges, channels in the ledges and other elements can be added or removed from those that are shown (or not shown) in the drawings to enable modification of the depicted embodiments.

[00279] In Fig. 20 shows an alternate implant anchor 20 that also uses a pair of internal hair capsules 30, a plurality of lateral anchor protrusions 70, and a closed channel 42, but no open channels at the distal end 34 and proximal end 40. In particular, this embodiment has protrusions 70 that protrude perpendicularly from the body of the anchor 24. The projections 70 form a cruciform shape due to the way the projections 70 intersect with the body 24 of the anchor 22.

[00280] In Fig. 21 shows an alternate version of the implant anchor 20 that uses a pair of inner hair capsules 30, a plurality of downward projections of the anchor 70, and no open or closed channels. In particular, the protrusions 70 protrude the entire length of the anchor body 24 and protrude downward at an angle to the proximal end 40 in a manner reminiscent of the stabilizers on a rocket.

[00281] Consistent with all other anchor options, the anchor options described in FIG. 19-21 contain similar materials and use closed channels (Figs. 19-20) and protrusions to support collagen ligature growth after subcutaneous implantation to obtain and retain collagen ligatures capable of anchoring a hair strand anchor to a hair implant recipient. As with all other channeled implant anchor embodiments, open and/or closed channels can also define a fracture line, as described above.

[00282] In Fig. 22a and 22b show a further implementation of the implant anchor 20. In particular, in fig. 22a shows a cruciform implant 22a with two branches with hair elements 24a and two branches with anchors 24b. Branches with hair elements 24a have corresponding distal ends 34, and branches with anchors 24b have corresponding proximal ends 40. Each branch with hair elements 24a contains internal hair capsules 30 with proximal end walls 38, distal openings 32, and each capsule 30 contains one hair 28. In addition, the implant anchor contains one closed channel 42, which is located at the center point 43.

[00283] In Fig. 22b is a partial perspective view of the distal end 34 of one of the hair feature branches shown in FIG. 22a. The cross section illustrates two hairs 28 emerging from two distal openings 32.

[00284] Consistent with all other anchor embodiments, the anchor embodiment described in FIG. 22a and 22b contains similar materials and uses closed channels to support collagen ligature growth after subcutaneous implantation to obtain and retain collagen ligatures that are capable of anchoring a hair strand anchor to a hair implant recipient. As with all other channeled implant anchor embodiments, open and/or closed channels can also define a fracture line, as described above.

[00285] In Fig. 23 shows another embodiment of an inverted Y-shaped implant anchor 20 226 having one branch with hairs 24a and two branches with anchors 24b. Hair branch 24a comprises internal hair capsules 30 with proximal end walls 38 and openings at the distal end 34 of branch 24a. More specifically, the implant anchor 22b is shaped like an inverted Y. The closed channel 42 is located at the central point where the branches 24a and 24b join.

[00286] In Fig. 24 is a perspective view of a further embodiment of the implant anchor 20 using two inner hair capsules 30 with proximal end walls 38 and distal holes 32 of the vertical body of the anchor 24. Below the inner hair capsules on the vertical component is a closed channel 42 flanked by two bridges. 26 above and below the closed channel. Extending from the proximal end 40 are four curved projections 70 which curve upward towards the distal end of the anchor. The entire anchor 22 resembles a fishhook or barbed anchor body 22b, with each of the curved projections 70 located radially, 90 degrees apart.

[00287] In Fig. 25 depicts yet another embodiment of an implant anchor 20 using a plurality of equidistant cup structures 71 surrounding the anchor body with concavities 52 open towards the distal end 34 of the anchor body and bulges 72 pointing downward towards the proximal end 40 of the anchor body. In particular, the anchor body has two closed channels 42 that are vertically aligned along the center position of the anchor body 24. In an embodiment, there are also two inner hair capsules 30 with proximal end walls 38 and distal openings 32.

[00288] In Fig. 26 shows another embodiment of an implant anchor 20 using a vertical anchor body 24 with a helical anchor shape 22e, in which the anchor body is helically surrounded by threads 76. The pitch ratio of the threads 76 is preferably 1 to 5, with the pitch ratio used here being defined as the diameter anchor body (excluding threads) separated by a distance along the longitudinal axis of the anchor body between adjacent thread ridges (i.e. the height of one full turn of the screw thread). Two inner hair capsules 30 having proximal end walls 38 emerge from two distal holes 32 on the anchor. Adjacent to the proximal end of the anchor, two bridges 26 are vertically aligned with the closed channel 42.

[00289] In Fig. 27 shows another embodiment of an implant anchor 20 using two inner hair capsules 30 that emerge from distal holes 32 and have proximal end walls 38. Anchor 22d is racquet-shaped and has a plurality of protrusions 70 extending laterally from the farthest head of the body. anchor, without such protrusions on the "handle" of the proximal part to the "racquet head". The closed channel 42 is located proximal to the inner hair capsules and in the center of the anchor body 24.

[00290] Consistent with all other anchor embodiments, the anchor embodiments described in FIG. 23-27 contain similar materials and use closed channels and protrusions (e.g., protrusions, bumps, etc.) to support the growth of a collagen ligature after subcutaneous implantation in order to obtain and retain collagen ligatures capable of anchoring a hair strand anchor to a hair implant recipient. . As with all other channeled implant anchor embodiments, open and/or closed channels can also define a fracture line, as described above.

[00291] In Fig. 28 shows another embodiment of an implant anchor 20 using a horizontal bar-shaped anchor body 74 22e with a plurality of distal holes 32 arranged in a grid pattern on the top surface 34a of the bar shape that forms the distal end of the implant anchor. In particular, each distal opening is an opening for an inner hair capsule 30 which contains a hair capsule 28. Four closed channels 42 are located between each pair of adjacent hair capsules 30. Thus, twelve parallel closed channels 42 extend across the entire width of the anchor between the hair capsules 30 and four parallel closed channels 42 run the entire length of the anchor between the hair capsules 30.

[00292] In Fig. 29 shows another embodiment of an implant anchor 20 having an irregular spherical or ovoid shape 22e and using a plurality of internal hair capsules 30 each containing a single hair 28 emerging from a distal opening 32 on the curved distal surface 34b of the anchor 22. In particular, the body of the anchor 24c is egg-shaped, with the curved distal surface 34b of the anchor being wider than the proximal bulbous shape 54. The closed channel 42 is located below the proximal end walls 38 of the inner hair capsules 30 and is centrally located in the body of the anchor.

[00293] Consistent with all other anchor options, the anchor options described in FIG. 28-29 contain similar materials and use channels to support the growth of a collagen ligature after subcutaneous implantation in order to obtain and retain collagen ligatures capable of anchoring a hair strand anchor to a hair implant recipient. As with all other channeled implant anchor embodiments, open and/or closed channels can also define a fracture line, as described above.

[00294] In Fig. 30 depicts an embodiment of a complete one-piece hair implant in which hair 28 forms the distal end 34 of the block. In particular, the hair element 28 is made of the same material as the body of the anchor 24 itself. The body of the anchor 24 includes a distal end 34 and a proximal end 40. The anchor has a plurality of parallel closed channels 42, each of which is separated by a bridge 26 and vertically aligned along the part of the anchor body 24. The open channel 44 is centrally located at the proximal end.

[00295] In Fig. 31 depicts a further embodiment of a complete one-piece hair implant in which a plurality of hairs 28 are formed at the distal end 34 of the anchor 22 from the body 24 itself. 42, each separated by a web 26, are vertically aligned along the central portion of the anchor body 24.

[00296] In Fig. 32 shows an embodiment of the implant of the invention in which the anchor 20 comprises a plurality of distal holes 32 with open channels 44 between each distal hole. Each distal opening contains a hair element 28 that emerges from the anchor. In certain embodiments, the hair elements are arranged as a hair tuft 78. In other embodiments, the hair elements are attached to one or more hair, braided, braided, twisted, coiled, wrapped, or otherwise shaped by mechanical or chemical means. The hair bun design may take a form that includes, but is not limited to, dreadlocks, braids, twists, or weaves.

[00297] Consistent with all other anchor options, the anchor option described in FIG. 32 contains similar materials and uses channels to support the growth of a collagen ligature after subcutaneous implantation in order to obtain and retain collagen ligatures capable of anchoring a hair strand anchor to a hair implant recipient. As with all other channeled implant anchor embodiments, open and/or closed channels can also define a fracture line, as described above.

[00298] In Fig. 33 shows a further embodiment of a one-piece (or one-piece) hair implant of the invention, wherein the anchor 20 comprises a plurality of main hair elements 28 extending from the distal end 34 of the implant. Each main hair element is a branched hair containing at least one accessory hair element 80. The accessory hair element is separated from the side or shaft of the main hair element and attached permanently, allowing the main and accessory hair elements to form together as a unit. . In certain embodiments, each main hair element, in addition to containing at least one permanent accessory hair element, may also contain at least one hair sprout structure 82. The hair sprout structures extend from the sides or trunks of the main and/or secondary hair elements and serve as attachment points at which additional accessory hair elements can be added and removed as desired.

[00299] Consistent with all other anchor embodiments, the anchor options described in FIG. 30-31 and 33 contain similar materials and use channels to support the growth of a collagen ligature after subcutaneous implantation in order to obtain and retain collagen ligatures capable of anchoring a hair strand anchor to a hair implant recipient. As with all other channeled implant anchor options, open and/or closed channels can also define a fracture line, as described above.

[00300] Preferably, such one-piece hair implants are formed from materials that mimic human hair. Such materials are better able to form synthetic hair having texture, flexibility, color and dimensions similar to or substantially similar to human hair.

[00301] Although the hair portion and the anchor portion of one-piece hair implants are preferably formed from the same material(s), within the scope of the present invention, different parts of one-piece hair implants are modified differently to provide different properties to different parts of the implant. For example, dyes and/or pigments can be selectively used to change the color of the hairline of the implant, and cross-linking agents can be used to selectively change the mechanical properties of desired parts of the implant.

[00302] It is also within the scope of the invention to form different parts of one-piece hair implants from various materials, where the materials are joined together to provide a substantially seamless connection between the hair and anchor parts of the implant.

[00303] Preferred materials for use in the preparation of one-piece embodiments of the hair implants of the invention are materials suitable for use in other embodiments of the anchors and hair implants discussed here.

[00304] Non-integral embodiments of the invention described and shown in the drawings may also be presented in alternative integral embodiments.

[00305] As noted above, the channels and protrusions of the anchor help secure the implant within the recipient by supporting the growth of the collagen ligature associated with the reaction of the foreign body. The projections also provide mechanical resistance to removal.

[00306] The foreign body reaction discussed above also provides protection against bacteria. This collagen sheath or wall will prevent bacteria that may have migrated beyond the distal area of the implant from entering the dermal or subcutaneous space.

[00307] When the reaction of the foreign body completes the creation of the collagen sheath, a contraction effect will begin to be observed over time. This contraction is beneficial because it will tighten the grip of the collagen sheath on the implant and further limit any gap formation between the implant and the living skin and thereby prevent bacterial entry.

[00308] Direct contact between the implant and living skin tissue is a bond created by a biochemical reaction. This binding force will also help with the attachment of the implant to the surrounding skin and thus will not allow a passageway for bacteria to enter.

[00309] The cleanliness of the patient's scalp is also an important aspect. Maintaining a bacterial load or low amount on the scalp or the area where the implants are placed will be helpful in preventing infection.

[00310] Another important aspect is to prevent not only infection but also inflammation caused by non-microorganisms. Inflammation is a reaction to foreign materials placed under the skin, such as hair and the silicone rubber component of a hair implant. This inflammatory response naturally occurs when a hair implant is placed. However, it is important to design the implant to induce a self-limiting inflammatory process in the immune system that will lead to chemical and physical changes, and this also applies to hair implants. Oxidation of the hair implant, its erosion, fracture and, more importantly, the subsequent jamming of part of the implant must be considered as a potential hazard in implantation, and therefore it is preferable to include in the invention the protective characteristics of the hair implant, designed to combat these hazards. If the oxidation and erosion of the implant were to occur to a significant extent, fragmentation of the implant cannot be ruled out. It is preferable to anticipate this by incorporating a fracture line into solid and non-solid embodiments of the hair implant invention to facilitate safe extraction and containment of the implant fragment in case of potential breakage. A fracture line is an element of an implant that has a reduced resistance to fracture relative to the balance of the implant, so that in the event of fragmentation, it occurs along the fracture line. On fig. 1 shows an example of a fracture line 46 co-linear with the canal line 42, 44. This planned vertical (or longitudinal) fracture line will make it easier to release the implant from the collagen ligatures through the canals 42, 44, thus facilitating the release of the already two vertical fragments of the fractured implant. Each fragment will contain at least one hair and a silicone structure. The fracture line prevents or at least minimizes the chance of creating random fragments that cannot be removed from the scalp when the hair is pulled. The fracture line predisposes the implant to fracture into two fragments. If a fracture occurs, the hair implant will fall out more easily because it has lost one of its key attachment mechanisms. With minimal force, the broken implant can be completely removed. This safety feature greatly reduces or eliminates any remaining hair fragments or implant parts, which in turn reduces or eliminates any acute or chronic inflammatory reactions. If the implant has been fully pulled out, then the subsequent collagen sheath will eventually dissolve and the subcutaneous architecture will change. In addition, after the implant has been placed in the desired position and the reaction of the foreign body has ended with the formation of a collagen sheath around the structure, if the implant fragment remains inside the body, then the collagen sheath structure will provide continuous protection and perform its function, surrounding the foreign body and protecting it from the immune system. If an inflammatory reaction were to occur, the body would try to get rid of this remaining fragment. This response would be limited to the skin surface (unlike the deep-seated designs of modern hair implants in the supracranial aponeurosis, with no withdrawal or retrieval mechanism), including the epidermal and dermal layers. More superficial inflammation is more likely to result in a pimple-like formation followed by a discharge of pus and fragments not dissimilar to the typical pimple formation found in certain conditions such as acne.

[00311] IMPLANTATION TECHNIQUE

[00312] Introduction

[00313] The preferred implantation technique includes several steps, including prior use of antibiotics and anti-inflammatory drugs, preparation of the recipient skin site, anesthesia, shaping of the recipient site, selection and placement of the hair implant, temporary stabilization of the hair implant, and skin closure with medical adhesive, aesthetic questions and postoperative use of antibiotics and corticosteroids, as well as instructions for proper scalp cleansing.

[00314] Natural appearance of hair emerging from the scalp

[00315] The use of antibiotics, as well as anti-inflammatory and antibacterial drugs at the site of the skin of the recipient are very important first steps in this process. Considering that there may be thousands of hair implants with corresponding thousands of needles piercing the skin, it is wise to start medical therapy to prevent infection and hyper-inflammatory response. An infection or hyperinflammatory reaction can lead to damage to the skin surface, epidermis and/or skin. This damage can result in visible dents in the recipient's skin area. This flaw will draw attention to the scalp, especially under certain lighting conditions, which will accentuate the ulcerated area.

[00316] Preparing the recipient skin site includes washing said skin site with soap and water, then applying Betadine or an acceptable surgical cleansing solution, then after the cleansing solution has dried, wiping with sterile alcohol. This skin cleansing sequence, with appropriate dressing of staff in addition to clean air in the treatment room at ISO 4 or 5, will eliminate or significantly reduce any bacteria or spores on the surgical site.

[00317] Formation of the recipient site is another critical step not only to form the hole for the hair implant, but also to minimize the actual puncture (eg, with an appropriately sized needle) or incision size (eg, with an appropriately sized scalpel) that minimizes the required healing and potential visible signs of skin ulceration. In addition, the resulting area should be parallel to the natural angle under which the hair usually comes out. This will allow the hair to naturally fall forward, sideways or back according to the patient's natural angle and natural hair style. The process of forming the recipient site itself involves a very similar technique currently used in hair transplant surgical procedures. The recipient site shaping method involves the use of a sterile 22-32 gauge needle, 11 or 15 gauge blade, or similar instrument. The needle is used to pierce the scalp at a very specific angle to a depth that depends on the desired pattern and thickness of the hair. For example, if a patient wishes to fill the occipital region of the scalp with hair implants, it will be observed that a "vortex" pattern naturally exists there. Given this, the needle used to pierce the skin in this area of the head will need to mimic this type of "whirlwind" pattern. This is achieved by piercing the needle at an acute angle to the scalp of the rotating type pattern. Then, when the hair implants are placed inside, they will come out of the scalp in a vortex. The depth of the needle injection should approach the normal follicular depth of 6 mm (in this case, to accommodate the hair in the scalp). If eyebrow hair is to be placed, then the needle pricks should be more superficial, about 3-4 mm deep, etc. Finally, the needle prick incisions will be as close together as possible. Considering that the inflammatory reaction is a normal reaction to a needle prick and a foreign body reaction to a silicone-tipped hair implant, it is recommended to place the implants 3-4 mm apart and then continue with subsequent implants in the same way for 3-4 treatments to eventually fill in the skin area to the desired density.

[00318] The choice of hair implant is very important for maintaining a natural appearance. For example, the fibers at the hairline on the head have smaller diameters than hair growing just 1.25 cm behind the hairline. This transition from thinner to thicker hair is normal and natural. The choice of smaller diameter fibers should be made for the hairline to mimic the natural look.

[00319] The silicone end of the hair implant is surgically inserted under the skin to a depth of approximately 3-6 mm, depending on whether the hair is being restored in the head, pubis, or other parts of the body. This silicone end will not detract from the natural look of the hair implant because the clear silicone used will be invisible to the eye and will remain mostly under the skin, with a small segment of 0.1 to 0.5 mm remaining above the skin (or below in some variations) leaving it out of sight.

[00320] Placement of hair implants

[00321] Appropriate anesthesia allows for correct placement of hair implants to the desired depth. Anesthesia involves applying a topical anesthetic cream such as lidocaine to the recipient site or area of the skin where the hair implants will be placed. 30 minutes after the application of local anesthetic, the area is cleaned and then an injectable form of tumescent lidocaine solution for surface anesthesia is administered. An anesthetic cream is applied after the area is cleaned with soap and water, then the anesthetic is removed, the area is wiped with sterile alcohol, then a tumescent solution of lidocaine is injected into the area, then betadine or another solution is injected.

[00322] In those embodiments where the hair is added to the anchor at a doctor's office, hair implant clinic, or manufacturer with or without an automated process, placement of the hair implant first involves opening a sterile package or just the anchor portion of the implant to be will then attach to a hair component, or an anchor part with hair already attached. If the sterile package contains only the anchor component, then the package will be opened in the doctor's office or clinic and the anchors will be placed in a sterile tray. The hair components are then added to the anchors. There are several ways to attach hair to an anchor, with a few examples discussed below.

[00323] Once the hair is attached to the anchor, it is ready to be injected under the skin. Fine jewelry sterile tweezers can be used to lift the hair implant by the silicone end and insert it into the hole in the recipient site made by the needle. After all hair implants are placed, the specialist applies a tiny drop of medical adhesive (such as cyanoacrylate or other quick-drying medical adhesive) to immediately stabilize the hair implant. This technique, using fine instruments, will minimize trauma, heal better, and result in a more natural-looking skin surface.

[00324] Density and pattern of hair

[00325] A hair implantation technique using very close placement of hair implants, an appropriately angled recipient site, and the use of fine jewelry tweezers and the use of a bonding technique to stabilize the hair implant will provide the desired hair density and a suitable hair pattern.

[00326] Close placement of hair implants on recipient sites with very small incisions by a needle piercing the scalp will increase the density per hair implantation session. The angle at which manipulations are performed on the recipient site is important for the formed hair pattern. For example, if one wants to have a natural swirl pattern on the top of their head, then it would be necessary to prepare a similar swirl pattern to mimic the natural hair pattern.

[00327] The use of thin and delicate jeweler's tweezers is essential in holding and properly placing the hair implant itself. The jeweler's tweezers allow the implant to be gently held to prevent damage and the placement of the implant in the scalp can be seen unhindered by the fact that the tweezers hold only a small portion of the distal portion of the implant without obstructing a direct view of the proximal end of the implant for easy placement at the recipient site.

[00328] The final application of the adhesive at the bottom of the hair implant will immediately stabilize and temporarily secure the implant, preventing it from being pulled out prematurely. Since the reaction of the foreign body and fixation of the hair implant takes 14-21 days, this temporary fixation mechanism will prevent hair loss and reduce hair density.

[00329] In Fig. 8 is a schematic top plan view of the scalp placement plan of implants 20 comprising vertical components 24, distal ends 34, distal holes 32 and hairs 28. The scalp overlay is a 10x10 grid in which each grid cell represents area of the scalp measuring 1×1 mm. Each implant 20 occupies two cells in the embodiment in FIG. 8. This placement would result in 50 implants (or follicular junctions) per cm ² , or 100 hairs per 1 cm ² when each follicular junction has two hairs.

[00330] Fixing the hair implant

[00331] The recipient site, being a surgical step by inserting a needle into the skin, is a key method of allowing access for the hair implant and approaching living tissue and a very important response of the immune system. This convergence of the hair implant and skin tissue will allow for the foreign body reaction and all subsequent anchoring (see the anchoring section above).

[00332] The final application of the adhesive at the bottom of the hair implant will immediately stabilize and temporarily secure the implant, preventing it from being pulled out prematurely. Because it takes 14-21 days for the foreign body to react and fix the hair implant, this temporary fixation mechanism will prevent hair loss.

[00333] Protection of the hair implant from the immune system

[00334] The recipient site, being a surgical step by inserting a needle into the skin, is a key method of allowing access for the hair implant and approaching living tissue and a very important response of the immune system. This convergence of the hair implant and the skin tissue will allow the foreign body reaction to proceed and form the collagen sheath. After the collagen sheath is fully formed, the foreign body reaction has completed its task of protecting the body by trapping the "foreign body" in this thick collagen sheath, and then the immune system reaction will stop. This collagen shell provides a double protection, protecting the implant from further reactions of the immune system and protecting the body from an implant that harms the body (foreign body reaction suggests that the foreign body is dangerous and thus shields it, protecting the body).

[00335] Safety Features of Hair Implants

[00336] With proper antiseptic cleansing of the skin, use of sterile anesthesia instruments, shaping of the recipient site and placement of the hair implant, stabilization of the hair implant, and immediate sealing of the epidermal incision site with adhesive will limit bacterial entry in the short term. The long-term features of bacterial barrier formation, fixation, and fixation of cracks and fragments are discussed above.

[00337] This method of implantation will allow, if desired, and complete removal of the implant in certain cases. The hair implant is inserted into the scalp as deep as the natural hair fibers are in the scalp - about 5-6 mm deep (only in the subcutaneous/skin areas where normal natural hair is found). The term "subcutaneous" as used herein is defined in its broadest sense to include epidermal, intradermal, and subcutaneous spaces, including subcutaneous fat. If the hair implant needs to be removed, this can be done by simple pulling (eg, plucking or pulling out normal hair). Thus, hair removal is a safety factor in case a follicle becomes infected. It is normal for natural hair follicles to occasionally become infected, so it follows that the same risk applies to the hair implant of the invention.

[00338] Infection and inflammation of the skin with hair is not uncommon. Many people naturally develop folliculitis, or inflammation of the hair follicles. This can be caused by a variety of reasons, including bacterial and non-bacterial sources, ingrown hairs, poor hygiene, hair loss and regrowth, etc. Some other causes of infection and inflammation come from simply shaving, others from hormonal problems, or even naturally occurring bacteria found in hair follicles and on the skin. Although infection and inflammation are found naturally and usually at low levels, the goal of hair implantation is to improve what is considered to be the natural occurrence of infection and inflammation in the skin that bears the hair.

[00339] It is predicted that the incidence of skin infections and inflammation associated with the invented implants will be less than in natural conditions. The absence of glandular organs and their secretion will make the area of the implant less favorable for bacterial growth. In addition, the anchor of the present invention does not have hormone receptors to trigger an inflammatory response, unlike natural hair follicles.

[00340] MANUFACTURE OF IMPLANTS

[00341] The implant anchor of the invention can be formed by a variety of different processes, including injection molding and 3D printing. The anchor preferably contains a material selected for certain characteristics such as appropriate hardness, molecular weight, crosslinking and strength. These characteristics will not only help provide the necessary strength to resist oxidation and degradation, but will also easily withstand the force of tweezer pressure during the implant technique. This aspect of tweezer placement is mainly important for hair transplantation when working with live follicular junctions. The placement of the tweezers can injure and crush living hair follicles, but in the case of hair implants, this is of course not a risk.

[00342] Materials that are highly resistant to prolonged chemical interaction with the immune system are preferred. Longevity of implants with high strength is desirable. If the hair is physically pulled out, the goal is to remove the entire implant in one or two pieces, thereby preventing it from breaking apart (except for the fracture line) and leaving parts of the implant under the skin.

[00343] Medical silicone is the most preferred material for forming the anchor. Other materials suitable for use in forming an anchor include, but are not limited to, metals (including, but not limited to, precious metals, metalloids, and other metals), biocompatible polymers (including, but not limited to, silicones, silicone elastomers, acrylics, and others). resins, plastics, polyethylene, PTFE, polyesters, PVC, PMMA, hydrogels, etc.), ceramics (including but not limited to silicates, glass, porcelain, carbon, etc.), natural biomaterials (including bone, based on calcium phosphate, etc.) and any combination thereof (defined here as composites).

[00344] In a preferred embodiment, implantable medical silicone is used to manufacture the implants. Silicone material is usually in liquid form and consists of two parts. When two parts, part A and part B, are mixed, a chemical reaction will occur, resulting in the formation of silicone rubber. This liquid-solid reaction can be controlled by keeping the mixture cold to slow down the liquid-solid reaction and allow time for the liquid silicone to enter the mold. After injection into the mold, heat is applied to complete the liquid-to-solid formation reaction.

[00345] The mold preferably contains a plurality of cavities to be filled with a liquid that is to solidify to form the anchors of the implants. The number of cavities is not particularly limited, and in certain embodiments may vary from 1 or 10 or 100 or 1000 or 10,000 cavities to 10 or 100 or 1000 or 10,000 or 100,000 cavities per mold.

[00346] The dimensions of the cavity are determined by the desired dimensions of the resulting implant. In certain embodiments, the cavities have a depth of 1-10 mm or 3-9 mm or 5-7 mm or 6 mm with a maximum diameter of 0.2-1.2 mm or 0.4-1.0 mm or 0.6-0 .8 mm or 7.0 mm.

[00347] The fluid in the cavities should preferably be free of air bubbles, voids, and the like. In certain embodiments, the shape of the anchor includes two plates that are used in a process that minimizes or prevents the formation of air bubbles, the first plate has a plurality of through holes and the second plate covers the holes in the first plate. Two plates are immersed in silicone fluid, with the second plate being used to push the silicone fluid through holes in the first plate (like a plunger on a syringe) until the two plates touch each other. The excess silicone fluid is then scraped off the surface of the first plate to provide a mold having a plurality of cavities filled with substantially bubble-free silicone fluid.

[00348] In the one-piece hair implants of the invention, strands of hair are formed together or as part of the anchor body using, for example, molds including the anchor body and hair, and/or pulling the strands out of the anchor body while it is still in its uncured state.

[00349] In non-solid embodiments, the hair strands to be inserted into the anchor are preferably pre-coated with silicone (or other silicone-compatible binder or primer, such as alkoxysilane monomers or polymers, as described in US Pat. No. 5,061,284 (101)) to a length for example, 2-10mm or 6-8mm or 7mm and then allowed to form a solid body. The length of this coating applied to the hair strands is preferably chosen to be 1 mm greater than the depth of the anchors into which the hair strands will be placed, so that the coating extends 1 mm above the anchor and remains external to the epidermal surface after implantation. In other embodiments, the implementation of the length of the coating is from 0.1 or 0.5 mm to 1.5 or 2 mm more than the depth of the anchor.

[00350] After the coating of the hair strands has dried to form a solid, the hair strands are placed in mold cavities filled with silicone fluid. Each mold cavity can accept 1, 2, 3, 4 or more strands of hair. The mold is then heated to solidify the silicone and form implants with one or more hairs each. The implants are then demoulded, sterilized and packaged for distribution and use.

[00351] In certain embodiments, the hair will be inserted and then secured by several possible mechanisms.

[00352] In a preferred distal-to-proximal embodiment, the adhesive is applied approximately 6 mm from the proximal end of the hair and then fed into the distal opening of the inner hair capsule until it reaches the proximal end wall of the hair capsule.

[00353] In the first preferred embodiment of the method of proximal and distal introduction, the hair is not first glued, but inserted into the proximal opening of the vertical component hair capsule, then the hair is pushed until only 6 mm of the proximal end is visible, then to this end by 6 mm, the adhesive is added, and finally, the hair continues to be pulled until it is completely in the hair capsule.

[00354] In a second preferred embodiment of the proximal and distal insertion method, the hair is not first glued, but first knotted at its proximal end and then fed into the proximal opening of the knot capsule until only about 6 mm of the proximal end of the hair is visible. . Adhesive is then applied to this 6 mm end (which will contain knots) and the hair continues to be fed through the hair capsule until it reaches the most distal end of the capsule node.

[00355] Preferably, the opening of the hair capsule through which the hair will be inserted is tapered to facilitate insertion of the hair by the technician (or machine if automated) and to allow more adhesive to remain in place to increase adhesion.

[00356] The knot capsule is an enlarged proximal end of the hair capsule shaped to provide a knotted hair portion that has a larger diameter than the untied portion of the hair shaft. The hair capsule distal to the nodular capsule has a narrower diameter than the nodal capsule so that the knotted hair is too wide to exit the nodal capsule and enter the hair capsule. The diameter of the nodular capsule is preferably 500-600 µm, and the length of the nodal capsule is preferably 500 µm to 6 mm.

[00357] In certain embodiments, the implementation of the vertical component will have a proximal end of the outer surface, which will be rounded. The arc will be 180 degrees, and the diameter of the circle will be from 500 microns to 2 mm. If there is an oval shape, then the largest dimensions of the oval will be the same.

[00358] Preferably, at least some and more preferably all of the anchor's edges are rounded. This includes the embodiments depicted in the drawings.

[00359] There are many types of body hair, including the scalp, face, eyelashes, eyebrows, arms and legs, pubis, etc., so the manufacturing process can be adjusted to create hair implants for the skin area in question. For example, eyebrow hair implants will be shorter than head hair implants.

[00360] In an alternative embodiment, the final assembly of the hair implants is performed by the end user (physician, physician assistant, hair specialist, etc.). Sterile anchors are supplied to the user, who selects the treatments and hair that are appropriate for the particular patient, and then, prior to implantation, bonds the hair to the anchors using an adhesive, for example, suitable for bonding the hair (or synthetic hair) to the anchor material. Suitable adhesives include, but are not limited to, cyanoacrylates.

[00361] As discussed above, the angle of exit of the hair strands from the anchor is best varied depending on the site of implantation. Thus, the placement of the hair strands in the mold cavities can be varied to give the implants a hair exit angle ranging from 1° to 90°. Also, to achieve a similar or similar effect, it is possible to use strands of hair in the production process that are curved, at an angle or other non-linear. Thus, for example, a strand of hair having an angle of 100° 5 mm from its proximal end may be inserted into a mold cavity 6 mm deep such that the strand of hair will emerge from the resulting anchor at an angle of 10° to the surface.

[00362] Although the invention has been described in detail and with reference to specific examples, it will be obvious to a person skilled in the art that various changes and embodiments can be made to it, within the scope of the invention.

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Reference numbers

20. Implant

22. Anker

22a. Cross anchor

22b. Inverted Y Anchor

22c. Anchor in the form of teeth

22y. Anchor in the shape of a racket

22d. Anchor in the form of a bar

22nd. egg anchor

22nd. screw anchor

24. Vertical component or anchor body

24a. Branch with hair element

24b. Branch with anchor

24th century Egg-shaped anchor body

26. Jumper

27. Connecting surface 27a and 27b

28. Hair or hair element

30. Inner hair capsule

32. Distal foramen

34. Distal end

34a. Top surface

346. Curved distal surface

36. Proximal opening

38. Proximal end wall of the inner hair capsule

40. Proximal end

40a. proximal end

40b. proximal end

42. Closed channel (or closed cavity)

42a. Closed channel (or closed cavity)

42b. Closed channel (or closed cavity)

43. Center point

44. Open channel (or open cavity)

46. Fracture line

48. Nodular capsule

50. Knot

52. Concavity

54. Proximal bulbous form

56. Epidermis

58. Dermis

60. Follicular union

62. Follicle

64. Scalp

66. Roughness

68. Round indent

70. Ledge

71. Cup design

72. Bulge

74. Horizontal component or anchor body

76. Thread

78. Hair bun

80. Auxiliary hair element

82. Structure of a hair sprout

Claims (77)

1. Hair implant intended for subcutaneous implantation, which includes: a) an anchor containing anchor body and at least one collagen receiving structure selected from the group consisting of at least one channel passing through the anchor body and an element of the outer surface of the anchor body; and b) at least one strand of hair protruding from the distal end of the anchor body; wherein at least one collagen receiving structure is configured to support the growth of the collagen ligature after subcutaneous implantation of the hair implant so as to fix the anchor on the hair implant recipient, and there is no hair in the collagen receiving structure. 2. Hair implant according to claim 1, in which: the anchor contains silicone; the anchor is shaped for subcutaneous implantation; the anchor contains a fracture line designed to facilitate breaking of the anchor along the fracture line for easy removal of the implant after subcutaneous implantation; the anchor is configured to provide a scaffold for collagen growth after subcutaneous implantation; the hair implant contains at least two strands of hair; and at least one of the at least two strands of hair is attached to the anchor on one side of the fracture line, and at least one of the at least two strands of hair is attached to the anchor on the opposite side of the fracture line in such a way that each fragment formed during rupture of the implant, contains at least one of at least two strands of hair. 3. The hair implant according to claim 1, wherein the anchor body comprises a first inner hair capsule and a second inner hair capsule, at least one collagen-receiving structure comprises at least one channel located between the first inner hair capsule and the second inner hair capsule, there is no hair in at least one channel, the hair implant contains at least two hair strands, the first inner hair capsule encloses the retained portion of at least the first of the hair strands, and the second inner hair capsule encloses the retained portion of at least the second from strands of hair. 4. The hair implant according to claim 1, wherein at least one collagen-receiving structure comprises at least one channel, the anchor comprises a first anchor body and a second anchor body connected by at least one bridge that spans at least one channel, at least one channel is free of hair, the first body of the anchor contains the first inner hair capsule, the second body of the anchor contains the second inner hair capsule, the hair implant contains at least two strands of hair, the first inner hair capsule contains a retained part of at least the first of the hair strands, and the second inner hair capsule encloses the retained portion of at least the second of the hair strands. 5. Hair implant according to claim 1, 2, 3 or 4, wherein at least one strand of hair has a diameter of 0.02 to 0.2 mm. 6. Hair implant according to claim 1, 2, 3 or 4, wherein at least one strand of hair has a length of 1 to 50 cm. 7. A hair implant according to claim 1, 2, 3 or 4, wherein at least one strand of hair is a strand of human hair or a strand of synthetic hair. 8. Hair implant according to claim. 1, 2, 3 or 4, in which at least one strand of hair is a synthetic hair containing polymer threads selected from the group consisting of polypropylene, polyvinyl chloride, polyamide, polyethylene, polyacrylonitrile, polyvinylidene chloride, polyurethane, polyester and their copolymers. 9. Hair implant according to claim 1, 2, 3 or 4, in which the largest size of the anchor is 0.1-2.5 mm. 10. Hair implant according to claim 1, 3 or 4, wherein the anchor body contains a biocompatible polymer, silicone, silicone polymer, metal or metal alloy. 11. Hair implant according to claim 1, 2, 3 or 4, in which the anchor consists of silicone. 12. Hair implant according to claim 1, 2, 3 or 4, in which the anchor does not have hinged flaps. 13. The hair implant according to claim 1, 2, 3 or 4, wherein the hair implant does not contain metal components. 14. A hair implant according to claim 1 or 2, wherein the retained portion of at least one strand of hair is retained in the inner hair capsule of the anchor body. 15. The hair implant of claim 14, wherein the inner hair capsule extends from the first distal opening to the second distal opening such that both ends of the at least one hair strand protrude from the distal end of the anchor body. 16. The hair implant according to claim 14, wherein the proximal end of at least one hair strand is located and enclosed in an inner hair capsule, and the distal end of at least one hair strand protrudes from the distal end of the anchor body. 17. Hair implant according to claim 1, 2, 3 or 4, which is integral in structure. 18. A hair implant according to claim 1, 2, 3 or 4, wherein at least one collagen-receiving structure contains at least one channel. 19. Hair implant according to claim 1, 2, 3 or 4, wherein at least one channel contains an open channel passing through the body of the anchor at its distal or proximal end. 20. Hair implant according to claim 1, 2, 3 or 4, wherein at least one channel contains a closed channel passing through the body of the anchor. 21. A hair implant according to claim 1, 2, 3 or 4, wherein the anchor body has at least two channels passing through it. 22. The hair implant of claim 21, wherein the at least two channels comprise parallel open channels located at opposite ends of the anchor body. 23. The hair implant of claim 21, wherein the at least two channels comprise parallel closed channels extending through the body of the anchor. 24. The hair implant of claim. 21, wherein at least one of the channels is an open channel located at the distal end or proximal end of the anchor body, and at least one of the channels is a closed channel passing through the anchor body. 25. A hair implant according to claim 1, 2, 3 or 4, wherein at least one channel defines a longitudinal fracture line through the body of the anchor that intersects at least one channel. 26. A hair implant according to claim 1, 2, 3 or 4, wherein the anchor has an irregularity on its distal lateral side, said irregularity effectively preventing the penetration of a bacterial infection. 27. Hair implant according to claim. 1, 2, 3 or 4, in which the anchor has a diameter decreasing from the proximal end to the distal. 28. Hair implant according to claim. 1, 2, 3 or 4, in which the anchor has a diameter that increases from the proximal end to the distal. 29. A hair implant according to claim 1, 2, 3, or 4, wherein the anchor has a diameter that is substantially constant from proximal to distal. 30. A hair implant according to claim 1, 2, 3 or 4, wherein the anchor has a mean section concavity equidistant from the proximal to the distal end of the hair implant. 31. Hair implant according to claim 1 or 2, in which: at least one receiving collagen structure contains at least one channel; at least one canal is free of hair; and the anchor body contains the first conical side, the second conical side, the first inner hair capsule located inside the anchor body parallel to the first conical side and covering the retained part of at least one first hair strand, the second inner hair capsule located inside the anchor body parallel to the second conical side and enclosing the retained portion of at least one second strand of hair. 32. Hair implant according to claim 1 or 2, in which: at least one receiving collagen structure includes at least one channel; at least one channel is free of hair; and the anchor body contains the first vertical side, the second vertical side, the first inner hair capsule located inside the anchor body parallel to the first vertical side and covering the retained part of at least one first hair strand, the second inner hair capsule located inside the anchor body parallel to the second vertical side and enclosing the retained portion of at least one second strand of hair. 33. The hair implant according to claim 1, wherein the retained portion of at least one strand of hair is retained in one inner hair capsule located along the central longitudinal axis of the hair implant, and at least one collagen receiving structure contains two parallel closed channels at the proximal end hair implant. 34. The hair implant of claim. 1, in which the retained part of at least one hair strand is retained in one inner hair capsule located along the central longitudinal axis of the hair implant, and in which at least one collagen-receiving structure contains one closed channel at the proximal end of the hair implant. 35. The hair implant of claim 4, wherein the at least one web comprises four parallel webs that are oval in cross section and enclose three closed channels and two open channels. 36. Hair implant according to claim 3, containing five parallel closed channels passing through the anchor body along the central longitudinal axis, and: on the sides of the channels are the first inner hair capsule and the second inner hair capsule; the top three channels are essentially identical in size; the two lower channels are greater than the three upper channels; the lower channel is the largest channel; and the diameter of the anchor decreases from the proximal end to the distal one. 37. The hair implant according to claim 1, in which the anchor body contains the first inner hair capsule and the second inner hair capsule, at least one collagen-receiving structure contains an element of the outer surface of the anchor body, containing three protrusions on each of two opposite sides of the hair implant, the hair implant comprises at least two hair strands, the first inner hair capsule encloses the retained portion of at least the first of the hair strands, and the second inner hair capsule encloses the retained portion of at least the second of the hair strands. 38. Hair implant according to claim 1, in which the body of the anchor has a cruciform shape with two branches with hair elements and two branches with anchors, the first branch with the hair element contains the first internal hair capsule, the second branch with the hair element contains the second internal hair capsule, the hair implant comprises at least two hair strands, the first inner hair capsule encloses the retained portion of at least the first of the hair strands, and the second inner hair capsule encloses the retained portion of at least the second of the hair strands. 39. Hair implant according to claim. 1, in which the body of the anchor has the shape of an inverted letter Y, including one branch with a hair element and two branches with anchors, the first inner hair capsule in the branch with a hair element, the second inner hair capsule in the branch with a hair element , the hair implant comprises at least two hair strands, the first inner hair capsule encloses the retained portion of at least the first of the hair strands, and the second inner hair capsule encloses the retained portion of at least the second of the hair strands. 40. The hair implant according to claim 1, in which the anchor body comprises a first inner hair capsule and a second inner hair capsule, at least one collagen-receiving structure contains an element of the outer surface of the anchor body, containing at least two protrusions at the proximal end of the anchor body, which curve upward towards the distal end of the anchor body, the hair implant comprises at least two strands of hair, the first inner hair capsule encloses the retained portion of at least the first of the hair strands, and the second inner hair capsule encloses the retained portion of at least at least the second of the strands of hair. 41. The hair implant of claim 1, wherein the anchor body comprises a first inner hair capsule and a second inner hair capsule, at least one collagen-receiving structure comprises an outer surface element of the anchor body comprising at least two cup-shaped protrusions surrounding the anchor body with recesses open to the distal end of the anchor body, the hair implant comprises at least two hair strands, the first inner hair capsule encloses the retained portion of at least the first of the hair strands, and the second inner hair capsule encloses the retained portion of at least the second from strands of hair. 42. The hair implant according to claim. 1, in which the anchor body contains the first inner hair capsule and the second inner hair capsule, at least one collagen-receiving structure contains an element of the outer surface of the anchor body having a thread spirally surrounding the anchor body, the hair implant contains at least two hair strands, the first inner hair capsule enclosing the retained portion of at least the first of the hair strands, and the second inner hair capsule enclosing the retained portion of at least the second of the hair strands. 43. The hair implant of claim. 1, in which the body of the anchor has a cuboid shape, the body of the anchor contains at least four internal hair capsules, each of which contains a retained part of at least one hair, at least one collagen-receiving structure contains at least at least one channel extending lengthwise between the hair capsules, and at least one channel extending widthwise between the hair capsules, wherein there are no hairs in the channels. 44. The hair implant of claim. 1, in which the body of the anchor has an ovoid shape, the body of the anchor contains more than two internal hair capsules, at least one collagen-receiving structure contains at least one channel located at the proximal end of the anchor body, at least there is no hair in one channel, and the hair implant includes at least two strands of hair with their retained parts enclosed in hair capsules. 45. Hair implant according to claim. 1 or 2, in which at least one receiving collagen structure contains at least one closed channel and at least one open channel, which run parallel through the body of the anchor along the Central longitudinal axis, and in which 1 -5 strands of hair are located at the distal end of the hair implant. 46. A hair implant according to claim 1, 2, 3 or 4, wherein at least one hair strand is a branched hair containing at least one accessory hair element and a hair sprout. 47. The hair implant according to claim 1, which is integral in structure, wherein at least one collagen receiving structure includes an element of the outer surface of the anchor body and the hair implant does not contain channels. 48. Method for hair restoration, including: formation of an incision on the skin; the introduction of an implant according to any one of paragraphs. 1-4, 33-44 or 47 in a section so that 0.1-2 mm of silicone coating at the proximal end of each of at least two strands of hair remains: a) outside the skin, b) above the epidermis, c) under the skin or d) under the epidermis; and applying an adhesive to the incision. 49. The method of hair restoration according to claim 48, in which the incision is made to a depth of 2-8 mm. 50. The method of hair restoration according to claim 48, in which the adhesive is cyanoacrylate. 51. The method of hair restoration according to claim 48, in which the collagen penetrates the channels of the anchor to form ligatures that bind the implant. 52. The method of hair restoration according to claim 48, in which the implant is inserted into the incision so that 0.1-2 mm of silicone coating at the proximal end of each of at least two strands of hair remains outside the skin or above the epidermis. 53. The method of hair restoration according to claim 48, wherein the implant is inserted into the incision so that 0.1-2 mm of silicone coating at the proximal end of each of at least two strands of hair remains under the skin or under the epidermis. 54. A method of manufacturing an implant according to any one of paragraphs. 1-4 or 33-44, including: providing a mold containing at least one cavity for forming the anchor; filling at least one cavity with silicone fluid; coating 2-10 mm of the proximal end of each of at least two strands of hair with a silicone coating; dipping the proximal end of each of the at least two strands of hair into the silicone fluid to such a depth that 0.1-2 mm of the silicone coating remains outside the silicone fluid in the cavity; solidifying the silicone fluid to obtain a solid product; removing the solid product from the mold; and sterilizing the solid product so as to prepare an implant.

Images