RU2812035C2 - Hair implants providing improved attachment and enhanced medical safety measures - Google Patents

Abstract

FIELD: hair implants.

SUBSTANCE: group of inventions relates to implantation of artificial hair. A hair implant for subcutaneous implantation comprises an anchor with an anchor body comprising a bulbous, convex base portion, the upper portion of the base portion and the lower portion of said base portion having the same diameter; and at least one collagen housing structure that includes an open channel or a continuous channel extending through the anchor body. At least one strand of hair protrudes from the distal end of the anchor body. The collagen housing structure is configured to allow the collagen junction to germinate after subcutaneous implantation of a hair implant so as to attach an anchor to a hair implant recipient, and the collagen housing structure does not contain hair. Options for a hair implant for subcutaneous implantation are disclosed.

EFFECT: reduction of complications after implantation.

14 cl, 38 dwg

Description

CROSS-REFERENCES TO RELATED PATENT APPLICATIONS

[0001] This PCT patent application claims priority under 35 USC §120 under US Patent Application Serial No. 16/293171, filed March 5, 2019, which is a continuation-in-part patent application and claims priority under 35 USC US Laws §120 under patent application PCT/US2018/044298, filed on July 30, 2018, which in turn is a partial continuation of the patent application and claims priority under section 35 US Code §120 under US patent application registration number No. 15/665369, filed July 31, 2017 (currently U.S. Patent No. 9993334) and U.S. Patent Application Serial No. 15/718637 filed Sept. 28, 2017 (currently U.S. Patent No. 10105212), and U.S. Patent Application Serial No. no. 15/718637 is a continuation-in-part patent application and claims priority under 35 USC §120 patent application registration number 15/665369. This PCT patent application also claims priority under 35 USC §120 under US Patent Application Serial No. 16/552740, filed August 27, 2019 (currently US Patent No. 10561490), which itself is a continuation-in-part patent application and claims priority under 35 USC §120 under US Patent Application Serial No. 16/293171. All prior patent applications are entitled "HAIR IMPLANTS COMPRISING ENHANCED ANCHORING AND MEDICAL SAFETY FEATURES" and the full description of each is incorporated in its entirety into this specification by reference.

BACKGROUND OF THE ART

1. FIELD OF TECHNICAL

[0002] The present invention relates to the field of hair replacement and, more particularly, to artificial hair implantation and implants.

2. DESCRIPTION OF THE BACKGROUND ART

[0003] For thousands of years, men and women have been concerned, ridiculed, and even suicidal by hair loss and the physical and cosmetic effects it has on their appearance, especially hair loss. on the scalp or face (2-6). The causes of hair loss are numerous and include: genetic disorders, genetic inheritance, stress caused by illness, fever or physical activity, chemotherapy, pulling on the hair, use of curling irons, chemical treatment of hair to shape or color it, etc. etc., aging, poor diet, thyroid disease, dermatomycosis and many other skin and non-skin diseases, the list of which is too large to be listed here (1, 7, 52, 90, 91, 114). Treatments for hair loss, including both medical and non-medical treatments, have generally produced unsatisfactory results (9-14, 51, 53, 59, 92, 93).

[0004] Hair loss treatment with currently available options does not fully meet the expectations of the vast majority of patients, regardless of whether the treatment is surgical, drug or non-drug. Other factors indirectly related not only to hair loss, but also to what hair loss treatments look like have a much greater impact on a person's mental and physical health. These factors include psychological, social and emotional trauma caused by the way a person looks and feels after hair loss, as well as the inadequate technical solutions available. The extent of psychological, social and emotional trauma does not end there. Prolonged anxiety and stress can also affect a person’s physical well-being (2-6).

[0005] A hair restoration treatment that meets most if not all of the patient's key expectations, such as natural looking and feeling hair, providing adequate hair thickness, low risk of complications, affordability and ease of use, will not only be in great demand, but will also reduce stress, anxiety, social and physical impacts on a person's life. Additionally, a solution to hair loss that provides more natural-looking hair would bring a very happy, confident, positive attitude and sense of well-being which, if it could be quantified, would eliminate many of the financial, social and emotional burdens that people carry affected by this problem (2-6).

[0006] Currently, there are many hair replacement technologies and methods, such as hair extensions and toupees, hair attached by weaving into a person's own hair and hair extension strands, hair implants, hair transplant surgeries and certain drug treatments that claim to promote hair growth, such as minoxidil, finasteride, etc. All of these tools provide limited success in one aspect or another, and these limitations not only prevent the optimization of expectations, but also lead to emotional breakdowns.

[0007] Hair extensions, hair attached by weaving into a person's own hair, and hair extensions often look and feel unnatural, leading not only to ridicule, but also to feelings of embarrassment or actual awareness of how unnatural the replacement system can look hair. Additionally, hair extensions, or hair attached by weaving into a person's own hair, can cause chronic skin irritation, leading to damage and permanent loss of remaining natural healthy hair.

[0008] Hair transplant surgery, another treatment for hair loss (51, 53), is not only very expensive, but also a very invasive surgical procedure associated with numerous medical risks, including infection and scarring of the scalp, impaired hair growth and unnatural appearance (26-30, 51, 54, 55, 57, 104, 108, 109, 113, 114).

Even if the hair transplant surgery is considered successful - without scarring, infection or impaired hair growth, in most cases the result will still be a very thin appearance of hair with reduced density (due to limitations in the healing ability of the skin), an unnatural looking line area hair growth due to pitted skin defects (as a result of surgical trauma to the skin at the recipient site) and inappropriate diameter of hair fibers placed (fibers should be very fine, small diameter hair fibers placed in the hairline area to ensure a natural transition, collection which is difficult) - all this leads to an unnatural appearance.

[0009] Drug therapy for diseases that are the root cause of hair loss can cure the pathological condition, but it usually does not lead to hair restoration due to injury and death of the hair follicular apparatus, and therefore patients are looking for a solution for hair restoration (1, 7 ). There are some medical conditions that cannot be treated with non-drug medications or surgery, such as certain types of alopecia (9).

[0010] Drug pharmacological therapies can prevent or directly stimulate hair growth - for example, finasteride and minoxidil (10-14, 59). Not only are these medications ineffective in reducing hair regrowth, but they are also not harmless medications with no risks or side effects. For example, finasteride may not only cause loss of libido, but it may increase the risk of developing a more aggressive type of prostate cancer. Minoxidil, a topical drug, is problematic because it can cause hair growth on other parts of the body such as the face, arms, legs and chest, a side effect that bothers many men and especially women. In addition, minoxidil may lower a person's blood pressure and cause fainting or loss of consciousness.

[0012] Hair implants are currently illegal in the United States; The US Food and Drug Administration (FDA) regulation on this issue has been in effect for many decades (15). Although some anecdotal reports claim some success associated with the use of artificial hair implants (21, 61-65, 87, 116, 117), the FDA has banned the use of this method using artificial hair implants due to numerous patient complaints and complications such as infection, scarring, chronic inflammation, and other problems (15–19, 60). Although artificial hair implantation is illegal in the United States, it appears to be legal in many areas of the world, including Asia and Europe. There are currently two companies that produce artificial hair for implantation, Nido (Japan) (20) and Biofibre (Italy) (21), and have been selling and marketing these artificial hair implants for decades.

[0013] An example of a hair implant is described in US Pat. No. 5,061,284 (Laghi) (117), in which the hair implant consists primarily of human hair on which artificial follicles are formed. And also, US patent No. 3596292 (Erb) (116) describes a hair implant design having an anchoring part extending under the surface of the skin and into the subcutaneous tissues, containing tissue-impermeable structures in the form of microfibers, microporous polymers, mesh foam polymers or hydrated hydrogels (see Fig. 14).

[0014] Another example of a hair implant is disclosed in US Pat. No. 9,492,196 (Keren) (87), which describes an anchor formed with a rough surface and a slot or hole through which hair is inserted such that the bulbous end of the root is implanted into the target textile. The size of the slot is such as to prevent the bulbous end of the hair from passing through it.

[0015] The three most well-known complications resulting from the use of commercially available hair implantation products are infection, inflammation, and scarring. The reasons why these complications occur are related to the type of materials used, the specific design of the materials, and the manner in which they are attached to the skin (surgical method). If the materials, design and techniques were improved, the risks and complications would be greatly reduced, making artificial hair implantation a viable alternative hair restoration solution for hundreds of thousands of hair loss patients worldwide.

[0016] Materials currently used in the manufacture of artificial hair implants generally include natural or artificial hair. Hair, whether natural or artificial, is a highly antigenic substance when it encounters and is detected by the immune system (22, 23). Given the hyper-reactivity and immune response to materials currently used, there appears to be little to no medical considerations regarding the choice of materials and how to minimize this negative interaction with the body. When this hair implant is placed deep into the scalp, an extended area of hair is in direct contact with the blood or immune system and is not completely protected from them. This deep placement and direct contact of hair with the body will significantly increase the likelihood of causing an increased and chronic inflammatory response, which is the source of chronic inflammation, pain, infection, granuloma formation and other serious problems.

[0017] The design of current hair implants is quite crude, again not reflecting any medical considerations regarding the natural anatomy, physiology, immunology or microbiological factors involved. This design, when interacting with the body, promotes inflammatory reactions and does not provide an adequate barrier to microbiological (bacterial) protection. In addition, there is no element in the hair implant design that even attempts to stop foreign invaders (bacteria) from entering the body, which, due to the lack of a barrier as part of the hair implant design, can cause serious acute and long-term chronic infections.

[0018] The current method of hair implantation involves placing artificial hair deep into and under the skin. This deep placement involves passing artificial hair under the skin and then attaching it to the deep fascia that lies just above the skull, called the scalp tendon (Galea Aponeurotica). Forming a loop and installing artificial hair into the tendon covering of the skull is an attachment mechanism that protects the hair from falling out. Although this is a very reliable method of placement, it again does not take into account medical considerations regarding adverse interactions with the immune system or an adequate bacterial barrier to prevent infection, and thus inflammation and complications associated with infection will often occur. It is necessary to take into account that this method, with the implementation of a very deep and specific placement in tissues of the fascial type, is limited to the area of the scalp and does not allow placement of hair in any other part of the body. In addition, there are serious problems inherent in this type of installation method which include a high risk of chronic inflammation, abscess formation, severe scarring and granuloma formation, etc. These complications can occur because the implanted artificial (or natural) hair is not protected or in direct contact with the immune system, and there is no barrier mechanism to prevent bacteria from entering the body. In addition, the implanted hair fiber may break down or fragment, leaving areas of highly antigenic hair fragments deep in and under the skin, leading to acute and chronic inflammation, potential formation of cysts and granulomas, chronic pain, and scarring.

[0019] Thus, it is desirable to provide improved artificial hair implants and hair restoration methods using them. In addition, it is desirable to create artificial hair implants that provide a natural appearance, are designed to be reliably implanted into the skin, do not cause an antigenic or inflammatory reaction, and can be implanted in a variety of densities and geometries.

[0020] All references cited herein are incorporated herein by reference in their entirety.

DISCLOSURE OF THE INVENTION

[0021] The first aspect of the present invention is a hair implant comprising: at least two strands containing at least any of the following: either mammalian hair or artificial hair; and an anchor that: (a) contains silicone, (b) is configured to be implanted subcutaneously, (c) contains a break line configured to facilitate breaking of the anchor along the break line for ease of removal of the implant after subcutaneous implantation, and (d) is configured to the ability to provide a scaffold for collagen sprouting after subcutaneous implantation, wherein at least one of the at least two strands is attached to an anchor on one side of the fracture line, and at least one of the at least two strands is attached to an anchor on the opposite side of the line fracture, such that each fragment formed as a result of fracture of the implant contains at least one of at least two strands.

[0022] In some embodiments, at least two strands are synthetic hair containing a polymer fiber selected from the group consisting of polypropylene, polyvinyl chloride, polyamide, polyethylene, polyacrylonitrile, polyvinylidene chloride, polyurethane, polyester, and copolymers thereof.

[0023] In some embodiments, the at least two strands have a diameter of 0.01 to 3 mm or 0.02 to 0.2 mm.

[0024] In some embodiments, the at least two strands have a length of from 1 mm to 500 cm, or from 1 cm to 50 cm.

[0025] In some embodiments, the armature has a maximum diameter of 0.1 mm to 2.5 mm or 0.1 to 5 mm.

[0026] In some embodiments, the anchor has a diameter that decreases from its proximal end to its distal end.

[0027] In some embodiments, the anchor has a diameter that increases from its proximal end to its distal end.

[0028] In some embodiments, the anchor has a diameter that is substantially constant from its proximal end to its distal end.

[0029] In some embodiments, the anchor has a depression in its middle portion that is approximately equidistant from the proximal end to the distal end of the hair implant.

[0030] In some embodiments, the anchor has an open channel at at least either the distal end or the proximal end of the anchor.

[0031] In some embodiments, the armature has at least one open channel, at least one solid channel, and at least one bridge between two vertical components.

[0032] In some embodiments, the anchor has a depression on its distal lateral side, which depression is effective in inhibiting bacterial infection.

[0033] In some embodiments, the anchor has at least one channel configured to accommodate and retain collagen connections so as to attach the anchor to a hair implant recipient.

[0034] In some embodiments, the anchor is composed of silicone.

[0035] In some embodiments, the armature does not include hinged flaps.

[0036] In some embodiments, the hair implant does not contain metal components.

[0037] A second aspect of the invention is a method of hair restoration, comprising: inserting a needle into the skin to form an incision; inserting an implant in accordance with the present invention into the incision such that 0.1-2 mm of silicone coating at the proximal end of each of the at least two strands remains: (a) outside the skin, (b) above the epidermis, (c) under the skin or (d) under the epidermis; and applying adhesive to the cut.

[0038] In some embodiments of the method, the incision is made to a depth of 2-8 mm.

[0039] In some embodiments of the method, the adhesive is cyanoacrylate.

[0040] In some embodiments of the method, collagen infiltrates the anchor channels to form connections that attach the implant.

[0041] In some 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.

[0042] In some embodiments of the method, the implant is inserted into the incision such that 0.1-2 mm of silicone coating at the proximal end of each of the at least two strands remains under the skin or under the epidermis.

[0043] The third aspect of the invention is a method of manufacturing an implant in accordance with the present invention, the method includes: providing a casting mold containing at least one cavity for forming an anchor; filling at least one cavity with liquid silicone; coating 2-10 mm of the proximal end of at least one strand with a silicone coating; immersing the proximal end of at least one strand in liquid silicone to such a depth that 0.1-2 mm of the silicone coating remains outside the liquid silicone in the cavity; curing liquid silicone to obtain a solid product; removing the solid product from the casting mold; and sterilizing the solid article so as to obtain an implant.

[0044] A fourth aspect of the invention is a hair implant comprising: at least one strand comprising at least any of the following: either mammalian hair or artificial hair; and an anchor that: (a) contains silicone, (b) is configured to be implanted subcutaneously, (c) contains a break line configured to facilitate breaking of the anchor along the break line for ease of removal of the implant after subcutaneous implantation, and (d) is configured to the ability to provide a scaffold for collagen sprouting after subcutaneous implantation, the at least one strand being contained in an internal hair housing chamber extending from the first distal opening to the second distal opening such that each end of the at least one strand remains outside the anchor.

[0045] A fifth aspect of the invention is a hair implant suitable for subcutaneous implantation, comprising:

a. a hair strand anchor containing:

i. anchor body;

ii. a first hair housing chamber located within said armature body;

iii. a second hair housing chamber located within said armature body; And

iv. at least one channel passing through said armature body, wherein said channel is located between said first hair chamber and said second hair chamber, and wherein the channel does not contain hair; And

b. at least one strand of hair, a portion of which is secured in at least one of the hair accommodating chambers, said secured portion of the hair strand also being enclosed in said hair accommodating chamber;

wherein said channel is configured to allow for the growth of a collagen connection following subcutaneous implantation of a hair implant, and wherein said channel is configured to accommodate and hold collagen connections capable of attaching said hair strand anchor to a hair implant recipient.

[0046] In some embodiments of the hair implant, said strand of hair is a strand of human hair or a strand of artificial hair.

[0047] In some embodiments of the hair implant, said anchor body is made of a biocompatible polymer, silicone, silicone polymer, metal, or metal alloy.

[0048] In some embodiments of the hair implant, at least one end of the hair strand protrudes from the distal end of the anchor body.

[0049] In some embodiments of a hair implant, said first hair housing chamber is in fluid communication with said second hair housing chamber to form a U-shaped hair housing chamber, wherein said strand of hair is secured in said U-shaped hair housing chamber. hair in such a way that both ends of said strand of hair protrude from the distal end of the anchor body.

[0050] In some embodiments, the hair implant comprises at least two strands of hair, with the proximal end of each strand of hair located and enclosed within one of said hair housing chambers.

[0051] In some embodiments of the hair implant, the channel is an open channel extending through the anchor body at its distal end or at its proximal end.

[0052] In some embodiments of the hair implant, the channel is a continuous channel extending through the armature body.

[0053] In some embodiments of the hair implant, the anchor body has at least two channels passing through it.

[0054] In some embodiments of the hair implant, the at least two channels are parallel open channels located at opposite ends of the anchor body.

[0055] In some embodiments of the hair implant, the at least two channels are parallel continuous channels extending through the armature body.

[0056] In some embodiments of the hair implant, 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 continuous channel extending through the anchor body.

[0057] In some embodiments of the hair implant, a channel extending through the anchor body effectively defines a longitudinal fracture line through said anchor body that intersects the channel.

[0058] A sixth aspect of the invention is a hair implant suitable for subcutaneous implantation, comprising:

a. a hair strand anchor containing:

i. first anchor body;

ii. second anchor body and

iii. at least one bridge connecting said first armature body to said second armature body so as to connect at least one free space between said armature bodies, said free space being free of hair; And

b. at least one strand of hair, a portion of which is secured in at least one of the anchor bodies, said secured portion of the hair strand being enclosed in said anchor body;

wherein said bridge connecting said anchor bodies is configured to allow the collagen connection to grow and retain after subcutaneous implantation of the hair implant, wherein said collagen connections are formed so as to attach said hair strand anchor to the recipient of the hair implant.

[0059] In some embodiments of the hair implant, said strand of hair is a strand of human hair or a strand of artificial hair.

[0060] In some embodiments of the hair implant, said hair strand anchor is made of a biocompatible polymer, silicone, silicone polymer, metal, or metal alloy.

[0061] In some embodiments of the hair implant, each of these anchor bodies has a chamber located therein for housing the hair.

[0062] In some embodiments of the hair implant, the hair implant comprises at least two strands of hair, with the proximal end of each strand of hair located and enclosed within one of said hair housing chambers.

[0063] In some embodiments of a hair implant, said hair receiving chamber of the first anchor body is in fluid communication with said hair receiving chamber of the first anchor body to form a U-shaped hair receiving chamber, wherein said portion of the hair strand is secured in said U -shaped chamber for housing hair such that both ends of said hair strand project from the distal end of the hair strand anchor.

[0064] In some embodiments of the hair implant, a portion of said U-shaped hair housing chamber is located in said bridge.

[0065] A seventh aspect of the invention includes a method of subcutaneously implanting a hair implant into a hair implant recipient. The method includes:

a. providing any of the hair strand anchors described in the present specification;

b. applying adhesive to part of the first strand of hair;

c. introducing said portion of a first strand of hair into a first hair receiving chamber;

d. applying adhesive to part of the second strand of hair;

e. introducing said portion of a second strand of hair into a second hair receiving chamber; And

f. placing the hair strand anchor in the subcutaneous tissues of the recipient, thereby causing a foreign body response such that the anchor becomes encapsulated collagen, and the sprouting of the collagen junction passes through the channel of the anchor, thereby attaching said hair strand anchor to the hair implant recipient.

[0066] In a first preferred embodiment of the proximo-distal hair guidance method, no adhesive will be applied to the hair initially, but it will first be introduced into the proximal opening of the hair placement chamber of the vertical component, and then the hair will be pushed through until Only 6 mm of its proximal end is visible, then glue is added to this 6 mm end, and finally, the hair continues to be pulled until it is completely in the hair placement chamber.

[0067] In a second preferred embodiment of the proximal-to-distal hair management method, the hair will not initially have any adhesive applied to it, but will first be knotted at its proximal end or otherwise processed or otherwise manipulated (e.g., melted or built up). via a bolus of adhesive such as glue) to make the bulbous end smaller in size than the larger opening of the nodule chamber and larger in size than the smaller opening of the nodule chamber, and then fed into the proximal opening of the nodule chamber until only approximately 6 mm of the proximal end of the hair is visible. Glue is then applied to this 6mm end (which will contain the nodules) and finally, the hair continues to be pulled through the hair chamber until it reaches the most distal end of the nodule chamber.

[0068] In some embodiments of the hair implant, said at least one free space effectively defines a longitudinal fracture line passing through said anchor of the hair strand that intersects said bridge.

[0069] In some embodiments, the hair implant further comprises at least a second bridge connecting said first armature body to said second armature body and bridging at least one free space between said armature bodies.

[0070] In some embodiments of the hair implant, said second bridge is parallel to the first bridge.

[0071] An eighth aspect of the invention is an anchor comprising: (a) a first hair receiving chamber configured to receive at least one strand of hair; (b) a second hair receiving chamber configured to receive at least one strand of hair; and (c) at least one channel extending through said anchor between the first hair receiving chamber and the second hair receiving chamber, wherein: (i) the anchor is configured to be implanted subcutaneously with at least one strand of hair secured by at least one at least in one of the hair receiving chambers - either in the first hair receiving chamber or in the second hair receiving chamber; (ii) the channel is configured to allow the growth of the collagen junction after subcutaneous implantation by placing and retaining collagen junctions capable of attaching an anchor to the recipient of the hair implant.

[0072] In some embodiments of the anchor, the at least one channel defines a longitudinal fracture line through the anchor that intersects the channel such that the anchor is configured to break along the fracture line when sufficient force is applied to facilitate removal of the anchor.

[0073] One of the unique and original technical features of the present invention is a channel or free space located within (for example, in the middle) of the armature between the hair chambers, which allows the armature body surrounding the channel around to protect the channel from breaking into many fragments, in in contrast to the porous Erb mesh (116). For example, a porous Erb mesh has holes that are not surrounded by a significant portion of the armature body, and the thin walls between the pores will be vulnerable to fragmentation into many pieces. Moreover, if the canal fragments despite the thick armature body surrounding it, the canal will fragment in a specific way so that it occurs exactly halfway between these two hair chambers.

[0074] A ninth aspect of the invention is an anchor comprising (a) a hair strand anchor comprising: (i) an anchor body; (ii) a hair housing chamber located within the armature body; and (iii) at least one channel extending through the armature body; and (b) at least one strand of hair, a portion of which is secured within and enclosed within the hair receiving chamber; wherein the at least one channel is configured to allow the growth of a collagen connection after subcutaneous implantation of the hair implant, and wherein the at least one channel is configured to accommodate and hold collagen connections capable of attaching a hair strand anchor to a hair implant recipient.

[0075] In some embodiments of the anchor, a single continuous channel extends through the body of the anchor and near its proximal end; and a single hair housing chamber is located along the central longitudinal axis of the hair implant.

[0076] In some embodiments of the anchor, a single open channel extends through the body of the anchor in the region of its proximal end; and a plurality of continuous channels also pass through the armature body.

[0077] In some embodiments of the armature, the plurality of solid channels are two parallel solid channels.

[0078] In some armature embodiments, a single open channel is located between parallel solid channels.

[0079] A tenth aspect of the invention is a hair implant suitable for subcutaneous implantation, comprising: (a) an anchor comprising: (i) an anchor body and (ii) at least one collagen housing structure selected from the group consisting of the channel passing through the armature body, and the design features of the outer surface of the armature body; and (b) at least one strand of hair protruding from a distal end of the anchor body, wherein the at least one collagen housing structure is configured to allow the collagen junction to germinate upon subcutaneous implantation of the hair implant so as to attach the anchor to a recipient of the hair implant. .

[0080] In some embodiments of the hair implant, the at least one strand of hair has a diameter of 0.02 to 0.2 mm.

[0081] In some embodiments of the hair implant, the at least one strand of hair has a length of from 1 cm to 50 cm.

[0082] In some embodiments of the hair implant, the at least one strand of hair is a strand of human hair or a strand of artificial hair.

[0083] In some embodiments of the hair implant, at least one strand of hair is artificial hair containing polymer fibers selected from the group consisting of polypropylene, polyvinyl chloride, polyamide, polyethylene, polyacrylonitrile, polyvinylidene chloride, polyurethane, polyester, and copolymers thereof .

[0084] In some embodiments of the hair implant, the anchor has a largest diameter ranging from 0.1 to 2.5 mm.

[0085] In some embodiments of the hair implant, the anchor body comprises a biocompatible polymer, silicone, silicone polymer, metal, or metal alloy.

[0086] In some embodiments of the hair implant, the anchor consists of silicone.

[0087] In some embodiments of the hair implant, the anchor does not include hinged flaps.

[0088] In some embodiments of the hair implant, the hair implant does not contain metal elements.

[0089] In some embodiments of the hair implant, the anchor portion of at least one strand of hair is secured in the internal hair housing chamber of the anchor body.

[0090] In some embodiments of the hair implant, an internal hair housing chamber extends from the first distal opening to the second distal opening such that both ends of at least one strand of hair protrude from the distal end of the anchor body.

[0091] In some embodiments of the hair implant, the proximal end of the at least one hair strand is located and enclosed in an internal hair housing chamber, and the distal end of the at least one hair strand projects from the distal end of the anchor body.

[0092] In some embodiments, the hair implant is an integral structure.

[0093] In some embodiments of the hair implant, the at least one collagen housing structure includes at least one channel.

[0094] In some embodiments of the hair implant, the at least one channel is an open channel extending through the anchor body in the region of its distal end or in the region of its proximal end.

[0095] In some embodiments of the hair implant, the at least one channel is a continuous channel extending through the anchor body.

[0096] In some embodiments of the hair implant, the anchor body has at least two channels passing through it.

[0097] In some embodiments of the hair implant, the at least two channels are parallel open channels located at opposite ends of the anchor body.

[0098] In some embodiments of the hair implant, the at least two channels are parallel continuous channels extending through the armature body.

[0099] In some embodiments of the hair implant, 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 continuous channel extending through the anchor body.

[00100] In some embodiments of the hair implant, the at least one channel defines a longitudinal fracture line through the armature body that intersects the at least one channel.

[00101] In some embodiments of the hair implant, the anchor has a depression on its distal lateral side, which depression is effective in inhibiting bacterial infection.

[00102] In some embodiments of the hair implant, the anchor has a diameter that decreases from its proximal end to its distal end.

[00103] In some embodiments of the hair implant, the anchor has a diameter that increases from its proximal end to its distal end.

[00104] In some embodiments of the hair implant, the anchor has a diameter that is substantially constant from its proximal end to its distal end.

[00105] In some embodiments of the hair implant, the anchor has a depression in its middle portion that is approximately equidistant from the proximal end to the distal end of the hair implant.

[00106] In some embodiments of the hair implant: (a) the anchor contains silicone; (b) the anchor is configured to be implanted subcutaneously; (c) the anchor includes a fracture line configured to facilitate breaking of the anchor along the fracture line for ease of removal of the implant after subcutaneous implantation; (d) the anchor is configured to provide a scaffold for collagen sprouting after subcutaneous implantation; (e) the hair implant contains at least two strands of hair; and (f) at least one of the at least two strands of hair is attached to the anchor on one side of the fault line, and at least one of the at least two strands of hair is attached to the anchor on the opposite side of the fault line such that each fragment formed by breaking the implant contains at least one of at least two strands of hair.

[00107] In some embodiments of a hair implant, the anchor body includes a first internal chamber for accommodating hair and a second internal chamber for accommodating hair, at least one structural member for accommodating collagen includes at least one channel located between the first internal chamber for accommodating hair hair and a second internal chamber for accommodating hair, at least one channel does not contain hair, the hair implant contains a plurality of hair strands, the first internal chamber for accommodating hair encloses a fastening portion of at least the first of the hair strands, and the second internal chamber for accommodating hair the hair comprises a fastening portion of at least a second of the hair strands.

[00108] In some embodiments of a hair implant, the at least one collagen housing 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 defines at least one channel, at least one channel does not contain hair, the first armature body contains a first internal chamber for accommodating hair, the second armature body contains a second internal chamber for accommodating hair, the hair implant contains a plurality of hair strands, the first internal chamber for accommodating hair encloses a fastening portion of at least the first of the hair strands, and the second inner hair housing chamber encloses a fastening portion of at least the second of the hair strands.

[00109] In some embodiments of the hair implant: (a) at least one collagen housing structure includes at least one channel; (b) at least one channel does not contain hair; and (c) the anchor body includes a first tapered side, a second tapered side, a first internal hair housing chamber located within the anchor body parallel to the first tapered side and enclosing a fastening portion of at least one first strand of hair, a second internal a hair receiving chamber located within the anchor body parallel to the second tapered side and enclosing a fastening portion of at least one second strand of hair.

[00110] In some embodiments of the hair implant: (a) at least one collagen housing structure includes at least one channel; (b) at least one channel does not contain hair; and (c) the anchor body includes a first vertical side, a second vertical side, a first internal chamber for accommodating hair located within the anchor body parallel to the first vertical side and enclosing a fastening portion of at least one first strand of hair, a second internal chamber for accommodating hair located within the anchor body parallel to the second vertical side and enclosing the fastened portion of at least one second strand of hair.

[00111] In some embodiments of the hair implant, the anchor portion of at least one hair strand is secured in a single internal hair housing chamber located along the central longitudinal axis of the hair implant, and at least one collagen housing structure includes two parallel continuous channels in area of the distal end of the hair implant.

[00112] In some embodiments of the hair implant, the anchor portion of at least one hair strand is secured in a single internal hair housing chamber located along the central longitudinal axis of the hair implant, and wherein the at least one collagen housing structure comprises a single continuous channel. in the area of the distal end of the hair implant.

[00113] In some embodiments of the hair implant, the at least one bridge comprises four parallel bridges that are oval in cross section and define three solid channels and two open channels.

[00114] In some embodiments, the hair implant comprises five parallel continuous channels extending through the armature body along a central longitudinal axis, wherein: (a) the channels are flanked by a first internal hair housing chamber and a second internal hair housing chamber; (b) the three uppermost channels are substantially identical in size; (c) the two lowest channels are larger in size than the three highest channels; (d) the lowest channel is the largest channel; and (e) the anchor has a diameter that decreases from its proximal end to its distal end.

[00115] In some embodiments of a hair implant, the anchor body includes a first internal chamber for accommodating hair and a second internal chamber for accommodating hair, at least one collagen accommodating feature comprises an outer surface feature of the anchor body comprising three protruding portions on each of two opposing sides of the hair implant, the hair implant includes a plurality of hair strands, a first inner hair receiving chamber encloses an anchoring portion of at least a first of the hair strands, and a second inner hair receiving chamber encloses an anchoring portion of at least a second of strands of hair.

[00116] In some embodiments of a hair implant, the anchor body has a cruciform configuration comprising two hair receiving sleeves and two anchor sleeves, the first hair receiving sleeve includes a first internal hair housing chamber, the second hair receiving sleeve contains a second an internal hair receiving chamber, the hair implant includes a plurality of hair strands, the first internal hair receiving chamber encloses an anchorable portion of at least a first of the hair strands, and the second internal hair accommodating chamber encloses an anchoring portion of at least a second of the hair strands hair.

[00117] In some embodiments of the hair implant, the anchor body has an inverted Y-shaped configuration comprising one hair element accommodating sleeve and two anchor sleeves, a first internal hair accommodating chamber within the hair accommodating sleeve, a second internal hair accommodating chamber in a sleeve for accommodating hair elements, the hair implant contains a plurality of hair strands, a first internal hair accommodating chamber encloses an attachment portion of at least a first of the hair strands, and a second internal hair accommodating chamber encloses an attachment portion of at least a second of strands of hair.

[00118] In some embodiments of a hair implant, the anchor body includes a first internal chamber for accommodating hair and a second internal chamber for accommodating hair, at least one collagen accommodating feature comprises an outer surface feature of the anchor body comprising a plurality of protruding portions at a proximal end of the anchor body that curve upward toward the distal end of the anchor body, the hair implant comprises a plurality of hair strands, a first inner hair receiving chamber encloses an anchorable portion of at least the first of the hair strands, and a second inner hair accommodating chamber encloses an anchoring portion. a portion of at least a second of the hair strands.

[00119] In some embodiments of a hair implant, the anchor body includes a first internal chamber for accommodating hair and a second internal chamber for accommodating hair, at least one structural element for accommodating collagen comprises a design feature of the outer surface of the anchor body comprising a plurality of cup-shaped projections encircling an anchor body, with recesses facing a distal end of the anchor body, the hair implant contains a plurality of hair strands, a first internal hair housing chamber encloses an anchorable portion of at least a first of the hair strands, and a second internal hair accommodating chamber encloses an anchorable portion a portion of at least a second of the hair strands.

[00120] In some embodiments of a hair implant, the anchor body includes a first internal chamber for accommodating hair and a second internal chamber for accommodating hair, at least one structural element for accommodating collagen includes a design feature of the outer surface of the anchor body containing a helical protrusion in a helical manner encircling the anchor body, the hair implant contains a plurality of hair strands, a first internal hair housing chamber encloses an anchoring portion of at least a first of the hair strands, and a second internal hair accommodating chamber encloses an anchoring portion of at least a second of the hair strands.

[00121] In some embodiments of the hair implant, the anchor body has a cuboid configuration, the anchor body contains at least four internal chambers for housing hair, each of which contains an anchored portion of at least one hair, at least one structural element for The collagen housing comprises at least one channel extending in the longitudinal direction between the chambers for accommodating hair, and at least one channel extending in the transverse direction between the chambers for accommodating hair, and the channels do not contain hair.

[00122] In some embodiments of the hair implant, the anchor body has an ovoid configuration, the anchor body contains more than two internal chambers for housing hair, at least one collagen housing structure includes at least one channel located in the proximal end of the anchor body, at least one channel does not contain hair, and the hair implant contains a plurality of hair strands, their attachment portions being enclosed in hair accommodating chambers.

[00123] In some embodiments of the hair implant, the at least one collagen housing structure comprises at least one solid channel and at least one open channel that extend parallel to each other through the anchor body along a central longitudinal axis, and wherein 1 -5 strands of hair are located at the distal end of the hair implant.

[00124] In some embodiments of the hair implant, the anchor body has a generally cylindrical shape, with the top portion tapering from a larger diameter to a smaller diameter. The armature body may contain two vertical columns of solid channels and a pair of open channels in the lower part of the armature body.

[00125] In some embodiments of the hair implant, the anchor body has a generally cylindrical shape, with an upper portion tapering from a larger diameter to a smaller diameter and comprising a bulbous, convex base portion, wherein the upper portion of the base portion and the lower portion of the base portion are substantially same diameter. The armature body may contain two vertical columns of solid channels and a pair of open channels in the lower part of the armature body.

[00126] In a particular embodiment of the hair implant, the anchor body is a generally rectangular body, and may include a bulbous base portion having flat sides and edges having smooth radii of curvature. The armature body may contain two vertical columns of solid channels and a pair of open channels in the lower part of the armature body.

[00127] In a certain embodiment of the hair implant, the body of the anchor is a body that is generally cylindrical in shape, but has a tapered distal portion. The armature body may contain a vertical column of solid channels and an open channel in the lower part of the armature body. The fault line runs vertically between the continuous channels, from the proximal end to the distal end of the anchor body. In addition, the main hair elements project outwardly upward from the distal end of the anchor body, and each main hair element may include ascending hair elements that originate at a predetermined height on the main hair element and end at the same height as the main hair element , to make it possible to obtain more hair per unit area to increase hair volume/density.

[00128] An eleventh aspect of the invention is a method of hair restoration, comprising: (1) forming an incision in the skin; (2) inserting an implant in accordance with the present invention into the incision such that 0.1-2 mm of silicone coating on the proximal end of each of the 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 adhesive to the incision.

[00129] In some embodiments of the hair restoration method, the incision is made to a depth of 2-8 mm.

[00130] In some embodiments of the hair restoration method, the adhesive is cyanoacrylate.

[00131] In some embodiments of the hair restoration method, collagen infiltrates the anchor channels to form connections that attach the implant.

[00132] In some embodiments of the hair restoration method, the implant is inserted into the incision such that 0.1-2 mm of the silicone coating on the proximal end of each of the at least two hair strands remains outside the skin or above the epidermis.

[00133] In some embodiments of the hair restoration method, the implant is inserted into the incision such that 0.1-2 mm of silicone coating at the proximal end of each of the at least two strands of hair remains under the skin or under the epidermis.

[00134] A twelfth aspect of the invention is a hair implant suitable for subcutaneous implantation, comprising: (a) an anchor comprising: (i) an anchor body having a cylindrical portion and a tapered portion, wherein one end of said cylindrical portion forms a proximal end of said anchor body and one end of said tapered portion forms a distal end of said anchor body; and (ii) at least one collagen housing structure selected from the group consisting of at least one channel extending through the anchor body; and (b) at least one strand of hair protruding from said distal end of the anchor body, wherein the at least one collagen receiving structural member is configured to allow the collagen junction to germinate upon subcutaneous implantation of the hair implant so as to attach the anchor to the hair recipient. implant, and the structural element for placing collagen does not contain hair.

[00135] In some embodiments of a hair implant, at least one strand of hair includes a main hair element having a first end formed at said distal end and having a free end opposite said first end, and wherein the main hair element further comprises at least one ascending hair element that originates from said main hair element at a predetermined distance above the distal end.

[00136] A thirteenth aspect of the invention is a hair implant suitable for subcutaneous implantation, comprising: (a) an anchor comprising: (i) an anchor body having a proximal end and a distal end; (ii) at least one collagen housing structure selected from the group consisting of at least one channel extending through the anchor body; and (b) at least one strand of hair protruding from the distal end of the anchor body, and wherein the at least one strand of hair comprises a main hair element having a first end formed at the distal end and having a free end opposite the first end, and wherein the main hair element comprises at least one additional hair element extending from the main hair element.

[00137] In some embodiments of a hair implant, the hair implant includes at least one hair extension that extends from a main hair element or at least one additional hair element, and wherein the at least one hair extension is configured to serve as an attachment point to which additional hair elements can be attached.

[00138] A fourteenth aspect of the invention is a hair implant suitable for subcutaneous implantation, comprising: (a) an anchor comprising: (i) an anchor body having a proximal end and a distal end; (ii) at least one collagen housing structure selected from the group consisting of at least one channel extending through the anchor body; and (b) at least one strand of hair protruding from the distal end of the anchor body, and wherein said at least one strand of hair comprises a main hair element having a first end formed at the distal end and having a free end opposite the first end and wherein the main hair element comprises at least one ascending hair element that originates from the main hair element at a predetermined distance above the distal end.

[00139] In some embodiments of the hair implant, the at least one ascending hair element includes a free end that is located at a distance from the distal end that is the same distance as the distance at which the free end of the main hair element is located from the distal end .

BRIEF DESCRIPTION OF THE DIFFERENT TYPES SHOWN IN THE DRAWINGS

[00140] The invention will be described with reference to the following drawings, in which like reference numerals denote like elements and wherein:

[00141] FIG. 1 is a front perspective view of an embodiment of an implant in accordance with the present invention;

[00142] FIG. 2A, 2B and 2C are front views of three other embodiments of an implant in accordance with the present invention;

[00143] In FIG. 3A, 3B, 3C and 3D show front views of four embodiments of anchors in accordance with the present invention;

[00144 ] In FIG. 4A, 4B and 4C show front views of three other embodiments of anchors in accordance with the present invention;

[00145] In FIG. 5A, 5B, 5C and 5D show front views of four other embodiments of anchors in accordance with the present invention;

[00146] In FIG. 6A, 6B, 6C and 6D show front views of four other embodiments of implants in accordance with the present invention;

[00147] FIG. 7 is a front view of another embodiment of an armature in accordance with the present invention;

[00148] FIG. 8 is a schematic top view of an embodiment of the invention in which the implants are placed in the patient's scalp at a distance from each other in an ordered pattern defined by a grid;

[00149] FIG. 9 is a front perspective view of another embodiment of an armature in accordance with the present invention;

[00150] FIG. 10A and 10B are front elevation views of additional embodiments of an implant in accordance with the present invention;

[00151] FIG. 11 is a front perspective view of another embodiment of an implant in accordance with the present invention;

[00152] FIG. 12 is a schematic view of a scalp that does not require hair implantation;

[00153] FIG. 13 is a schematic cutaway view of the skin showing the natural anatomy of hair follicles and follicular unit;

[00154] FIG. 14 is a table showing a summary of an embodiment of the present invention compared with the prior art;

[00155] FIG. 15A is a perspective view of yet another embodiment of an implant anchor that utilizes a single centrally located inner hair housing chamber and two proximal ends;

[00156] FIG. 15B is a top view of the embodiment shown in FIG. 15A;

[00157] FIG. 15C is a cross-sectional view of the implant anchor shown in FIG. 15A, made along the line 15C-15C shown in FIG. 15B;

[00158] FIG. 15D is a bottom view of the implant anchor shown in FIG. 15A, taken along line 15D-15D shown in FIG. 15A;

[00159] FIG. 15E is a side view of the implant anchor of FIG. 15A with a strand of hair that is shown located in the inner channel;

[00160] FIG. 16A is a perspective view of yet another embodiment of an implant anchor that utilizes a single centrally located inner hair housing chamber and a single proximal end;

[00161] FIG. 16B is a top view of the embodiment of FIG. 16A;

[00162] FIG. 16C is a cross-sectional view of the implant anchor of FIG. 16A, made along the line 16C-16C shown in FIG. 16B;

[00163] FIG. 16D is a side view of the implant anchor shown in FIG. 16A;

[00164] FIG. 17A is a perspective view of another embodiment of an implant anchor having three solid channels and corresponding open channels at its proximal and distal ends;

[00165] FIG. 17B is a top view of the implant of FIG. 17A;

[00166] FIG. 17C is a cross-sectional view of the implant taken along line 17C-17C shown in FIG. 17B;

[00167] FIG. 17D is a cross-sectional view of the implant taken along line 17D-17D shown in FIG. 17B;

[00168] FIG. 18 is a perspective view of another embodiment of an implant anchor in accordance with the present invention having two hair chambers and having a plurality of solid channels but no open channels;

[00169] FIG. 19 is a three-dimensional view of another embodiment of an implant anchor in accordance with the present invention, having a “tree-like” design with protruding parts deflected upward;

[00170] FIG. 20 is a perspective view of another embodiment of the anchor in accordance with the present invention, having a “tree-like” structure with lateral protruding parts;

[00171] FIG. 21 is a three-dimensional view of another embodiment of the anchor in accordance with the present invention, having a “tree-like” structure with protruding parts deflected downwards;

[00172] FIG. 22A is a front view of another embodiment of an implant anchor in accordance with the present invention having a cruciform configuration;

[00173] FIG. 22B is a partial perspective view of the implant anchor of FIG. 22A truncated along line 22B-22B shown in FIG. 22A;

[00174] FIG. 23 is a front view of another embodiment of the armature in accordance with the present invention having an inverted "Y" configuration;

[00175] FIG. 24 is a perspective view of another embodiment of an implant anchor in accordance with the present invention having a "meshing" configuration;

[00176] FIG. 25 is a perspective view of yet another embodiment of an implant anchor in accordance with the present invention having a plurality of "cup" structures along the anchor body;

[00177] FIG. 26 is a perspective view of yet another embodiment of an implant anchor in accordance with the present invention having a helical or “helical” design around the anchor body;

[00178] FIG. 27 is a perspective view of another embodiment of an implant anchor in accordance with the present invention having a racket-shaped configuration;

[00179] FIG. 28 is a perspective view of another embodiment of an implant anchor in accordance with the present invention having a "bar" configuration;

[00180] FIG. 29 is a front view of another embodiment of an implant anchor in accordance with the present invention having an ovoid or egg-shaped configuration;

[00181] FIG. 30 is a front view of an embodiment of an integral implant in accordance with the present invention, in which the hair element and the anchor body are formed from the same material;

[00182] FIG. 31 is a front view of another embodiment of an integral implant in accordance with the present invention, in which the hair elements and the anchor body are formed from the same material;

[00183] FIG. 32 is a front view of another embodiment of an implant in accordance with the present invention, in which a plurality of hair elements form or are attached to a stylized tuft of hair structure;

[00184] FIG. 33 is a front view of yet another embodiment of an integral implant according to the present invention, in which additional hair elements and additional structural elements are hair extensions from the side walls of the main hair elements;

[00185] FIG. 34A is an isometric view of yet another embodiment of the implant in accordance with the present invention, which utilizes a plurality of internal chambers to accommodate hair, the armature body having a generally cylindrical structure;

[00186] FIG. 34B is a sectional view of the implant shown in FIG. 34A along line 34B - 34B shown in FIG. 34A;

[00187] FIG. 35A is an isometric view of yet another embodiment of the implant in accordance with the present invention, which utilizes a plurality of internal chambers to accommodate hair, the anchor body having a generally cylindrical structure and a bulbous barrel-shaped design feature at the base of the anchor body;

[00188] FIG. 35B is a planar plan view of the implant shown in FIG. 35A;

[00189] FIG. 36 is a partial, isometric view of yet another embodiment of the implant in accordance with the present invention, which utilizes multiple internal chambers to accommodate hair, with the armature body having a generally cylindrical design similar to the embodiment of FIG. 34A and 34B, but containing fewer chambers for accommodating hair and hair elements;

[00190] FIG. 37A is an isometric top and front view of yet another embodiment of an implant in accordance with the present invention, in which the anchor body has a generally rectangular body structure and a bulbous anchor body base;

[00191] FIG. 37B is an isometric view from below the implant of FIG. 37A;

[00192] FIG. 37C is a top view of the implant plane of FIG. 37A; And

[00193] FIG. 38 is an isometric view of yet another embodiment of an implant in accordance with the present invention, in which the anchor body has a tapering upper portion and a column of vertically aligned solid channels through which a fracture line extends, and in which the distal end contains major hair elements having ascending hair elements originating at a given distance above the distal end and which terminate at the same height as the main hair elements.

DETAILED DESCRIPTION OF THE PREFERRED OPTIONS FOR CARRYING OUT THE INVENTION

[00194] The goal of implanting artificial hair into the body is to achieve a natural appearance with minimal or no side effects. Artificial hair implantation, in accordance with the present invention, achieves this goal by providing the patient with a feasible and safe hair restoration option for baldness that will meet and exceed the expectations of patients who desire not only additional hair on the scalp, but also hair on any part of the body, including also the facial area, limbs, torso and pubic area, without the undesirable effects inherent in previous and current methods.

[00195] Observation of the natural shape of existing living hair follicles and their anatomy has provided valuable information regarding the desired structural and functional elements of artificial hair implant materials, their design and installation techniques.

[00196] Natural hair appears to emerge from the deeper dermal layer of the skin. This is a very important observation (57, 86). When examining hair that is attached by weaving into a person's own hair, hair extensions or similar hair replacement systems, the hair extends above the level of the skin and often appears not only unnatural, but also does not match the natural hair color or hair density characteristics that are observed with natural hair growth on the sides and back of the scalp. When looking closely at these hair reconstruction systems, you can see the artificial substrate to which the hair is attached. In addition, the hair reconstruction system requires certain types of devices to attach the support to the skin, such as tape, glue, or certain types of clips. These types of systems are similar to wearing a thick woolen hat, which can be uncomfortable at times due to heat, sweating and irritation.

[00197] The natural anatomical density and structure of hair will vary depending on the age, gender and genetics of the individual. Very natural looking and thick hair can be achieved through hair implantation because, unlike hair transplant surgery, there is an unlimited amount of hair available for implantation. It is possible to mass produce hair implants as opposed to natural living hair follicles. Achieving results in obtaining appropriate hair density is also achieved through the use of a smooth and narrow implant design, which will allow each of the hair implants to be closely placed or brought closer to each other in addition to the available possibility of adding ascending hairs (additional hairs and elements that are processes described below ) to increase volume. The design of the hair implant preferably mimics the overall size and shape of the natural hair follicle (88, 89). This problem of achieving high hair density becomes critical for women and young men, because in the vast majority of cases they have very dense and thick hair, without signs of hair loss, thinning hair or any signs of baldness at all. Any type of hair restoration, be it medical, surgical or non-medical, that results in hair appearing sparse will result in a less than acceptable appearance for these patients, leading to frustration and low self-esteem.

[00198] Drug treatments such as minoxidil or finasteride cannot provide such success. Hair transplant surgery cannot achieve the goals of hair thickness due to the limited amount of "live" hair to transplant from the donor area, and placing living hair grafts too close to each other results in injury and death of hair follicles. Even with the most effective medical and surgical treatment, it is impossible to achieve 80 to 90 follicular units per square centimeter, which is the natural density of hair on the scalp (55). Artificial hair such as hair extensions, hair attached by weaving into a person's own hair, wigs, etc. can achieve the desired hair thickness and texture, but these systems look too unnatural and are very uncomfortable, causing heat generation, sweating and, in addition, skin irritation, inflammation and traction alopecia, leading to further natural hair loss (90-93).

[00199] Cells in the body, including skin cells, have natural connections with each other. These connections not only provide communication channels, but also protect the body from the penetration of bacteria. These junction mechanisms, also called tight junctions or desmosomes (33–38), provide anchorage to the hair follicle, protection from invading bacteria, and protection from immune cells approaching or contacting the hair fiber itself.

[00200] The natural flora or microbiological organisms of the skin are numerous. These microorganisms are largely harmless and provide benefits by interacting and cooperating with the immune system to help protect the body. However, these inhabited spaces are limited by the natural physical barriers present in the skin. Structural anchoring mechanisms and physical barrier mechanisms of the skin, including the hair follicle and its close relationship with the surrounding skin, glandular structures and desmosomal cellular junctions between cells, and the natural collagen layer surrounding the follicles, limit the penetration of natural skin flora into the deeper layers of the skin and the bloodstream. (39, 40, 41). The natural flora will change under certain circumstances, such as hair loss. If loss of a hair follicle occurs and its anatomical structure penetrating deep into the skin is no longer present, normal flora will no longer live there. When the hair implant is placed, this follicle anatomy will be recreated and bacteria will again be present in the superficial areas of the skin surface. When a hair implant forms an outer collagen cap or collagen sheath as a result of a foreign body reaction, a channel (or short distance) between the implant and the collagen will exist at a certain distance in the distal direction, which will somewhat mimic the anatomy of a natural follicle with its natural flora. When the collagen membrane is formed, there will be a strong physical barrier that prevents bacteria from penetrating into the deeper layers of the skin and into the blood or lymph flow. This type of collagen barrier is the same barrier that is found in the normal anatomy and histology of the natural hair follicle (89).

[00201] 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 destroying the organ that is the living hair follicle (30, 42, 43, 44). When a hair or hair follicle is out of place and outside its natural sheath, such as when there is an ingrown hair, the hair encounters the immune system. Ingrown hairs trigger a foreign body giant cell response (cells involved in the foreign body response), causing the immune system to try to encapsulate the hair or hair particles with collagen (45, 46). This is the same reaction that will be used in a positive manner to guide and form the collagen sheath around the hair implant of the present invention.

[00202] There are about 100,000 hairs on the human scalp and about 5 million on the human body. The scalp has about 120 square inches of skin containing hair. Each square inch, or 6.4 square centimeters, contains about 833 hairs, or about 130 hairs per square centimeter. See FIG. 12.

[00203] Hair loss is not felt or noticed until about 50% is lost. The ultimate goal of hair restoration is to achieve the appearance of a head full of hair, which can be achieved by providing only 50% of the normal amount of hair per unit area. The present invention allows for the appearance of a head full of hair, or a slightly lesser result for those individuals whose hair restoration goals are more modest.

[00204] In case of complete hair loss on the scalp, replacing 50% of the original amount will 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 rising hair, hair density can reach up to about 200 hairs per square centimeter. This is more than the required 65 hairs, but allows for the possibility of hair loss over time. The increased density will maintain the appearance of a head full of hair for a longer period of time between hair implantation sessions.

[00205] When examining the scalp, it will be noted that most hair follicles naturally cluster close together in clusters and are not typically identified as individual hair follicles. These natural groups are called "follicular units" or FUs. As shown in FIG. 13, follicular units 60 usually include 1, 2, 3 or 4 hairs 28, see (52). The hair 28 grows from a follicle 62 within the dermis 58 and emerges from the epidermis 56. This aspect of natural anatomy has been taken into account in the design and manufacture of artificial hair implants.

[00206] Hair follicle density and depth within the skin were also examined. Photos taken during surgery demonstrate the depth and density of hair follicles (51, 54, 55).

[00207] In addition to these key anatomical observations of the natural hair follicle, there are other functional elements such as sensory nerves, blood vessels supplying the hair follicle, sebaceous glands and other glandular structures involved in the production of certain fluid secretions associated with the functioning of the natural hair follicle. living hair follicles. The absence of such functional elements in artificial hair implants does not prevent the hair from achieving a very natural feel and appearance.

[00208] Thus, there are several features of the natural anatomical design that can be replicated in an artificial design to achieve the patient's goals of achieving a full or nearly complete set of natural-feeling and natural-looking hair. The artificial implants of the present invention preferably provide one or more of the following characteristics: (1) a natural appearance of hair emerging from the scalp, (2) natural hair thickness and texture, (3) adequate anchorage of the hair implant to prevent unwanted hair loss, and (4 ) protecting the artificial hair implant from the immune system and preventing short-term and long-term inflammation.

Hair implantation: design, function, and new innovative solutions

MATERIALS

Introduction

[00209] Medical grade silicone rubber and similar materials have been used for decades in cosmetic and medical applications as major components of implantable medical devices. Over the past few decades, these materials have been used by millions of people to enhance their faces, breasts, and other body parts. 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. Implant replacement is indicated, for example, in the case of long-standing, deformed or damaged silicone breast implants (and other cosmetic implants), when severe contracture, pain, psychological problems or an aggressive reaction to a foreign body occurs with the occurrence of collagen encapsulation of the medical device. (66-70, 73-75).

[00210] The anchor portion of the implant, with or without any adjuvant or need for additional chemical coating to ensure durability, will be in direct contact with the body and immune system. This material will cause a foreign body reaction. A foreign body reaction will result in the implant being walled off or encapsulated by collagen. This reaction will continue until the entire implant is surrounded by collagen. This enveloping of the implant around collagen is beneficial for many reasons. First, a collagen sheath completely surrounding the implant will shield the immune system from the implant itself, which is the purpose of the foreign body response to any foreign body. Second, collagen forms a chemical bond directly to the implant material, resulting in attachment or formation of an implant anchoring structure. Third, the collagen structure will contract over time, adding additional reinforcement and anchorage to the implant along the concave portions of the implant surface. Finally, and most importantly, this collagen sheath is naturally present in the normal anatomy of the hair follicle, which provides the highly antigenic hair follicle with a natural collagen barrier from the immune system and thus will provide the same function for the hair implant.

[00211] A foreign body response is the body's response to a foreign body entering or entering the body, such as a piece of metal, plastic, or foreign substance. The main purpose of this reaction is to protect the body by sequestering or encapsulating the foreign substance with collagen, thereby enclosing it and subsequently rendering the substance harmless to the body. Once this immune system response is complete, this encapsulation reaction will cease.

[00212] Based on the fact that the immune system's reaction to a foreign body leads to encapsulation by collagen, this mechanism can be practically used and used in a special way with respect to the process of engraftment and anchoring of the hair implant. This reaction can promote collagen production in a controlled and precise manner. The desired goals are to surround the hair implant and form a collagen sheath around it, provide antibacterial protection, provide significant anchoring structural elements necessary for implant fixation and successful hair implantation, and protect the implant from further immune system reactions such as chronic inflammation, etc. Foreign body reaction and sequence of events will be discussed below.

[00213] After the installation of hair implants, the body will detect that a foreign substance has been introduced into the body. The hair implant itself, with the silicone part or anchor, will be open or in direct contact with the body. This direct contact initiates a very special biochemical reaction of the immune system - a foreign body reaction.

[00214] This foreign body reaction is generally considered to be a late stage reaction in the inflammatory and wound healing process following implantation of a medical device or prosthesis. The purpose of this special type of reaction is to wall off or isolate this foreign substance in an effort to protect the body. This response, which is very different from the white blood cell response to a bacterial infection, consists of very special cells called macrophages and foreign body giant cells. These cells initiate an inflammatory response resulting in the formation of collagen, which ultimately completely surrounds and seals off the foreign body if possible, essentially encasing it in the collagen and making it safe or harmless while remaining in the body. It also leads to an inactive state of the immune system.

[00215] This resulting shell of collagen structure around the implant will prevent a chronic inflammatory response by completely shielding it from the immune system. Such a reaction in relation to the hair hair implant is desirable.

[00216] In addition, the collagen structure will help anchor the hair implant into the skin through a combination of biochemical reactions and physical interactions. The biochemical reaction involves the direct attachment of collagen to the silicone material.

[00217] Physical interaction between the newly formed collagen and the hair implant anchor will also occur. Given that in some embodiments the shape of the anchor is concave, the collagen will tightly wrap around the anchor or tighten around the anchor, preventing the anchor from being released from the skin. Another physical feature of the anchor is the channels. These channels will allow collagen to infiltrate the anchor, forming a loop of collagen that will help bind the implant with a natural biological connection. Biological collagen compounds will be one of the main mechanisms by which the anchor is fixed. If the anchor breaks along a fault line, which it is designed to do, if the anchor is subject to fracture or stress, the collagen connections will separate, causing instability in the resulting two pieces of anchor. This destabilization will allow the anchor to be easily released, thus preventing fragments from being retained within the body.

[00218] Finally, the combination of the effects of collagen envelopment and direct physical anchoring results in a tightening effect around the anchor around the collagen, which adds additional protective properties by preventing bacteria from entering between the anchor and the collagen shell due to the formation of a confined space there. Now that the foreign body (anchor) is embedded in collagen, the body's immune system has completed its protective function and will allow the embedded substance to remain in the body without further acute or chronic inflammatory reactions for the rest of its life.

[00219] It is very important to note that natural hair follicles also have a collagen sheath or sheath, which is a very important and interesting parallel that should not only be mentioned, but also emulated. As natural hair fibers develop during the embryonic period, this protective collagen sheath forms around the hair follicle. This does not happen by accident, but on purpose, because without this outer collagen covering, the body will attack the hair follicle, thinking it is a foreign body, and destroy it.

[00220] Thus, the foreign body response is put into practice to perform many of the above-mentioned functions by the hair implant and achieve goals such as securing and fixing the hair implant, preventing infection, ensuring a state of non-stimulation of immunological reactions to eliminate chronic inflammatory pathological conditions and prevent subsequent occurrence pain, discomfort and scarring.

Natural appearance

[00221] Achieving a natural appearance of hair emerging from the skin at the epidermal level can be achieved by using natural (or synthetic) strands of hair fibers and implanting these fibers in a manner that mimics the normal anatomy of the hair fiber-to-epidermis junction (without skin defects in pitting or unusual anatomical abnormalities). The materials needed for this are natural looking hair strands, whether natural or synthetic, and, for ease of discussion, silicone rubber to coat the ends of the hair. The tip of the hair, coated with silicone rubber, will be in direct contact with the skin or will be implanted into the skin itself. The key to natural-looking hair coming out of the scalp, or any area of skin containing hair, is closely related to the type of incision made (discussed in the section on implantation technique) and the shape of the silicone implant at the epidermal level (discussed in the section on design ).

[00222] The hair strand(s), natural or synthetic, can be selected by color, shape, length, etc. according to the anatomical location and cosmetic wishes and needs of the patient. For example, scalp hair implants can be customized to be long, short, straight, curly, black or blonde, etc. Hair implants can also be custom-made for the eyebrows, pubic area, and other areas of the body. See, for example, Otberg et al. (58).

[00223] In embodiments in which 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 since 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 optional coating material, such as medical grade silicone (or another substance or combination of materials, such as an additional outer layer of polycarbonate), will be in direct contact with the skin and immune system and thus play a role in more than just biochemical binding , physical retention, securing the anchor by forming a joint, to secure the implant, but also to reduce the oxidation reaction in an effort to preserve the integrity of the implant for a long time from breaking or destruction.

[00224] Materials suitable for the hair component of the implant of the present 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 the following polymers: polypropylene, polyvinyl chloride, polyamide, polyethylene, polyacrylonitrile, polyvinylidene chloride, polyurethane and polyester.

[00225] Hair suitable for use in the present invention can be straight, tightly curled, or loosely curled. Suitable hair can be dyed, partially dyed or undyed. The length of the hair fibers is not particularly limited, but suitable hair fibers preferably have a length of at least 5 cm, or at least 10 cm, or at least 15 cm to facilitate styling after implantation. Hair materials suitable for use in the present invention preferably have a diameter similar to that of 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 circular, as in natural hair.

Hair density and geometry and location geometry

[00226] The anchor preferably has a very narrow design that mimics the actual size of a natural hair follicle, allowing hair implants to be placed closely or closely together, providing greater density of hair per unit area. The anchor preferably has significant material strength and durability to withstand traction forces and oxidation reactions from the immune system.

Attaching a hair implant

[00227] The structure of the implant in accordance with the present invention plays a major role in securing 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 implant material makes it possible to reproduce the reaction to a foreign body, as a result of which a collagen shell is formed directly around the implant. This close bond will then lead to the formation of a biochemical bond between the collagen and the scaffold (i.e. the anchor). This bond, covalent and/or non-covalent, will provide the anchoring force. Another factor is that this material promotes the formation of collagen on the outside and inside the implant. The anchor preferably contains channels (defined here as free spaces of varying sizes, configured to be infiltrated by host tissue, and which include, but are not limited to: pores, grooves and channels), such that the foreign body response and subsequent collagen structure can infiltrate the anchor and act as a connection to hold the implant in place. The anchor material is preferably a collagen growth stimulator or collagen growth promoter to promote this.

[00228] According to the prior art of hair implantation, foreign body reaction is unfavorable for implantation and should be avoided. The present invention goes against the prior art by promoting a foreign body response and the resulting formation of a collagen cap or sheath and collagen bonding through the channels of the implants of the present invention to attach them to the scalp or other tissue.

[00229] For example, Erb et al. (116) argue that the goal is to avoid foreign body and rejection reactions, and Laghi (117) argues that foreign body reactions are destructive. Moreover, Erb et al. provided information on tissue growth resulting from a non-foreign body response that is cellular rather than collagenous in nature.

Protecting the hair implant from the immune system

[00230] The anchor material helps protect the hair implant from immune system attacks and oxidation, causing a foreign body reaction. The foreign body response will allow the body to surround the hair implant with a collagen barrier and thus “turn off” the immune system, since the goal and ultimate response of the foreign body response is to isolate the foreign body, which in this case is the hair implant itself. In addition, a more durable material will resist oxidation from the interaction between the implant material and the body. This oxidative process may come from the immune system or from local cells releasing certain chemicals that cause this reaction. Finally, the material preferably allows for a straight fracture (or fracture) line and eliminates fragmentation. The material preferably allows for a limited risk of breaking into small pieces. Information sources that provide information on other implantation methods, such as those presented by Erb et al. (116), Laghi (117) and Keren (87), do not take into account the potential problem of fragmentation, which can lead to retention of device fragments in the body and chronic inflammation, and do not propose a solution to this very important problem.

Measures to ensure the safety of hair implants

[00231] The materials used for implantable medical devices for human use have been studied and proven to be safe, and have subsequently been used for over 50 years. They have, of course, proven to be safe, but with limitations. For example, breast implants typically last about 10 years. Although they are not permanent, it is possible that they can be removed and then replaced. Based on this, hair implants can also last 10 years or more, possibly fall out naturally or simply stretch out, etc. In this case, hair implants can also be replaced.

CONSTRUCTION

Introduction

[00232] The design used for the hair implant in accordance with the present invention includes a specific size, shape and internal structure to ensure optimal achievement of certain goals, such as providing secure attachment, bacterial barrier, natural and desired hair density and placement geometry, as well as the structural integrity of the hair implant to prevent oxidation and destruction.

Natural appearance of hair as it emerges from the scalp

[00233] One of the key design factors for making hair implants as natural as possible is careful consideration of how natural hair exits the skin at the epidermal level. The standard or goal in developing a hair implant is that the hair implant emerges from the scalp with the same or similar epidermal-dermal anatomy as natural existing hair. Natural hair coming from the scalp (with all its natural anatomical features) is the ultimate goal to pursue.

[00234] Natural hair emerging from the epidermis has certain anatomical features, such as a narrow diameter of the exit pore and a certain angle of inclination to the surface of the epidermis, as well as its depth. These natural anatomical characteristics can be imitated through the use of certain design features in the hair implantation device. For example, by designing the distal end of a hair implant to be tubular in shape, having a minimum diameter and a corresponding distal to proximal extension slope, the hair implant will allow the diameter of the epidermal opening and the internal slope to be the same or similar to natural hair. Of course, this transformation in the epidermal region associated with shaping will occur during the healing process, which will include foreign body reaction and migration of the epidermis.

[00235] This natural appearance of hair emerging from the skin is a rare characteristic of most, if not all, hair restoration solutions. Wigs and toupees have hair coming out above the skin; completely unnatural. Hair transplant surgery will result in hair coming out from under the skin; however, in most cases, the techniques used usually result in damage to the skin, causing the skin pores to widen and increase in size and depth, often referred to as pitted skin.

Hair density and location geometry

[00236] The design of the anchor will also influence the density and geometry of the placement, and the shape of the anchor, having 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 given area, will allow more hair implants to be placed per unit area to achieve the hair density that is naturally noted in any area where hair is present. In some versions, the anchor fits into a cube measuring 10 mm x 10 mm x 10 mm.

[00237] Hair density and texture differ between men and women, young and old people, and people of different races and religions. Natural-looking hair, whether the implants are sparsely or closely spaced, can provide the desired hair density and desired pattern for each patient. A high density or "super thick look" for young men and women can be achieved with this sleek, narrow hair implant design allowing each hair implant to be closely aligned with each other, resulting in the appearance of a thick, natural hair arrangement. Conversely, in older men, a less dense arrangement can be used if desired.

[00238] The geometry of the hair arrangement is closely related to hair density. It includes the hair placement location and exit angle. For example, if an older man not only wants his hair to appear thinning, but also wants a receding hairline with a very thin crown area, this is easily achieved by physically placing implants on the desired areas of the skin. The exit angle is a more important characteristic on the temporal scalp and eyebrow area. In these places, the implant must be tilted at a sharper angle than is possible surgically when forming the recipient site. For example, when shaping a recipient site, the physician may only insert the needle/cutting device at a certain angle that is not sharp enough. The need for this sharp angle is crucial because if the eyebrow hair grows upward and outward instead of parallel to the skin, it will look very unnatural. To achieve this acute angle, the hair component itself will be tilted or twisted. Inserting these non-straight-shaped hairs into the silicone portion of the implant will provide that extra slope of hair output needed to give the hair a natural appearance.

Attaching a hair implant

[00239] Design, including external and internal shape, will be the most significant aspect regarding the fixation of the hair implant.

[00240] The internal structure consists of one or more channels. The foreign body reaction will result in collagen production throughout the entire surface of the silicone portion, including the inner surfaces of the channels. As collagen forms in the silicone-lined tunnels, it will form a natural loop of collagen, much like a natural anchoring suture or connection, helping to secure the implant to prevent it from being pulled out.

[00241] The outer structure, which preferably has defined concave portions, will provide gripping points after collagen has formed around the implant. Once the implant is surrounded by collagen, and since there are concave and convex parts, more physical force will be required to pull the implant out of the skin due to the additional resistance exerted on the implant by the collagen.

[00242] Another factor to consider is the contraction of collagen that occurs over time. For example, with silicone breast implants, a foreign body reaction causes a collagen sheath to form around the implant. This collagen shell will contract or exert force on the breast implants over time. This is not beneficial for breast implants as it results in discomfort and pain for the patient; however, this is advantageous for the device being a hair implant. This collagen formation and contraction force will help secure the hair implant. Additionally, this contraction force will provide a more secure, tight barrier between the implant and the skin/subcutaneous area, which will prevent bacterial migration.

Protecting the hair implant from the immune system

[00243] With reference to FIG. 1, the anchor 22 of the implant 20 includes two vertical components (or anchor bodies) 24 connected by a bridge 26, with a closed channel 42 (or free space) located above the bridge and an open channel 44 located below the bridge. In this embodiment of the invention, which simulates a natural follicular unit having two hairs and two hair follicles, each hair 28 is contained within an internal hair housing chamber 30 that has a distal opening 32 and a proximal blind-terminating portion 38 near the proximal end of the implant 20. Hair 28 exits distal end 34 of implant 20 through distal opening 32. In accordance with a preferred embodiment of the invention, at least one hair 28 is located on each side of fracture line 46 (discussed in more detail below), such that there is at least one hair in each of these two fragments resulting from the breaking of the implant 20.

[00244] The anchor 22 is preferably about 2-8 mm or 3-6 mm in length (i.e., along the longitudinal axis defined by the strand(s) of hair within the anchor; from top to bottom in the perspective view shown in FIG. 1) , preferably from about 500 μm to 2.5 mm in width (i.e., along an axis transverse to the longitudinal axis; from left to right in the perspective view shown in Fig. 1) and preferably from about 500 μm to 2.5 mm in width depth (i.e. towards and away from the observer in the perspective view shown in Figure 1). The dimensions of the anchor are preferably variable depending on the location of the hair placement.

[00245] For example, scalp hair penetrates the skin to a depth of approximately 6 mm, while eyebrow hair is typically shorter, approximately 3-4 mm in length. This depth design not only matches the natural penetration depth of the natural hair follicle, but also provides additional favorable safety measures. This minimal depth design allows the body to encapsulate or coat with collagen and hide the implant from the immune system, unlike prior art hair implant systems. Additionally, once the immune system has completed the formation of collagen as a result of the foreign body reaction, the interaction between the silicone implant and the immune system will cease. This is not the case with prior art hair implantation techniques, in which a relatively very long section of highly immunogenic hair (natural or synthetic) is exposed to the immune system due to the hair being placed deep into the scalp and loops being created or the hair being connected to the deep fascia pilaris. parts of the head, the tendon covering of the skull (galea aponeurotica). This prior art system results in a state of chronic inflammation with further complications such as infection, scarring, granuloma formation and pain. Coating such an implant of long hair with collagen, with a knot at the end and the hair passing through several layers of tissue, turned out to be difficult from the point of view of complete collagen encapsulation. Without complete collagen encapsulation of the hair implant, the foreign body reaction will continue indefinitely, preventing the immune system from shutting down or remaining inactive.

Measures to ensure the safety of hair implants

[00246] There are two main problems associated with the safety of a hair implant - infection and inflammation.

[00247] Infection is caused by living organisms such as bacteria, fungi and viruses. Living organisms naturally live on the surface of the skin in a symbiotic manner (in most cases). When the anatomy of the skin changes, such as when the skin is cut, these bacteria can then enter the body and cause infection. Hair implantation will involve a temporary small puncture with a needle, then the hair implant is placed into this puncture and healing occurs. It is important that healing occurs without infection or inflammation.

[00248] Hair implants should be designed to prevent the downward movement of microorganisms around the hair implant, thereby preventing the occurrence of infection. Prevention of infection is achieved through the internal and external shape of the hair implant, foreign body reaction and formation of the collagen sheath, contracture formation of the collagen sheath over time, biochemical binding reaction at the interface between collagen and silicone material, distal design and cleanliness of the patient's hair and scalp . Such design features are observed in the natural anatomy of the hair follicle, such as the collagen sheath, biochemical connections at cell contacts and tight junctions, and tapering distally.

[00249] The external shape, in particular the tapering of the distal end, will result in a minimal epidermal opening, thereby limiting the size of the portal of entry to infection and contact with bacteria in the hair implant-skin contact areas. In some embodiments, there will be an upward and then downward angulation of the device in the distal direction, tilted upward 30-45 degrees, which will prevent an easy downward path for bacteria to travel. The growth of epithelial cells that will form along the distal end of the implant and attach to the newly formed collagen sheath will provide additional cellular contact and proximity to the implant, thereby limiting bacterial access.

[00250] Attachment-related general aspects, which include the external and internal shape of the hair implant, also contribute to the safety elements associated with preventing the entry of bacteria by forming a tight apposition between the implant and living tissue, which prevents the formation of an entry gate for bacterial entry.

[00251] The cross-sectional shape of the armature and its constituent elements is round or oval in some embodiments of the invention.

[00252] In some embodiments, the anchors have an external shape that resembles the letters of the alphabet. These embodiments (collectively referred to as “Alphabet Anchors”) are identified in this specification by the term “Anchor” followed by the letter that the anchor most closely resembles (e.g., A-Anchor, H-Anchor, W-Anchor, and V -shaped anchor). There will be some variations of anchors corresponding to the designated letter, but the general shape corresponding to the designated letter will continue to be apparent. Each Alphabet Anchor contains at least one channel and at least one jumper.

[00253] Preferred A-armature embodiments are shown in FIG. 3A, 3B, 3C and 3D. Each embodiment includes two vertical components 24 (or armature bodies) connected by at least one bridge 26 and further includes one open channel 44 (or free space). Embodiments differ in the number of solid channels they have. The embodiment shown in FIG. 3A has one continuous channel 42, the embodiment shown in FIG. 3B does not have a continuous channel, the embodiment shown in FIG. 3C has two solid channels 42, and the embodiment shown in FIG. The 3D has three continuous channels 42. The channels are essentially concentrated along the fault line of the anchors.

[00254] Preferred H-armature embodiments are shown in FIG. 4A, 4B and 4C. Each embodiment includes two vertical components 24 connected by at least one bridge 26 and further includes two open channels 44 of substantially similar size. Design options differ in the number of solid channels they have. The embodiment shown in FIG. 4A does not have a continuous channel, the embodiment shown in FIG. 4B has one continuous channel 42, and the embodiment shown in FIG. 4C has two continuous channels 42. The channels are substantially centered along the fault line of the anchors.

[00255] Preferred embodiments of the W-shaped armature are shown in FIG. 5A, 5B, 5C and 5D. Each embodiment includes two vertical components 24 that diverge distally from each other, are connected by at least one bridge 26, and further includes at least one open channel 44. The embodiment shown in FIG. 5A has no solid channels and has two open channels 44, the embodiment shown in FIG. 5B has one solid channel 42 and two open channels 44, the embodiment shown in FIG. 5C has two solid channels 42 and two open channels 44, and the embodiment shown in FIG. 5D, has one open channel 44 and does not have any solid channels. The channels are essentially concentrated along the anchor fault line.

[00256] Each anchor (alphabetic or other configuration) preferably has two vertical components, at least one horizontal component, and at least one channel.

[00257] The vertical component is a portion of the anchor that is designed to receive hair.

[00258] The horizontal component, also referred to as a “bridge,” is an attachment region that connects adjacent vertical components. The bridges preferably have a length of from 100 μm to 4 mm and are from 100 μm to 4 mm in diameter. The number of bridges present that hold the vertical components together correlates with the number and types of channels formed.

[00259] Channel sizes preferably range from 100 μm to 6 mm in length and from 100 μm to 2 mm in diameter.

[00260] With reference to the embodiments shown in FIG. 2A and 2B, each of the vertical components 24 includes an internal hair housing chamber 30 having a distal opening 32 at the distal end 34 of the armature 22. The internal hair housing chamber 30 preferably has a diameter of 25-50 μm.

[00261] The embodiment shown in FIG. 2A has a nodule receiving chamber 48 in the region of the proximal end of each inner hair receiving chamber 30. Each knot receiving chamber 48 has a diameter larger than the diameter of the corresponding inner hair receiving chamber 30, such that a knot 50 having a diameter larger than the diameter of the inner hair receiving chamber 30 is held within the knot receiving chamber, and thus thus attaches the hair 28 to the anchor 22. The size of the nodule housing chamber is preferably in the range of 500 μm to 6 mm in length and 100-750 μm or 100-500 μm in diameter.

[00262] The embodiment shown in FIG. 2B has a proximal opening 36 in the region of the proximal end 40 of each inner chamber 30 for receiving hair.

[00263] Within the scope of the invention, each proximal end of each internal hair chamber within the anchor has an end portion independently selected from the group consisting of: a nodule chamber, a proximal opening, and a proximal blind termination portion. Preferably, each proximal end of each internal hair chamber within the anchor has the same type of end portion (eg, two nodule chambers, two proximal openings, or two proximal blind termination portions). In some embodiments, at least one distal opening 32 and/or at least one proximal opening 36 is conical in shape and the extensions open outward.

[00264] In FIG. 2C shows an embodiment with a "loop-shaped" internal hair housing chamber 30 that extends from one vertical component 24 through a bridge 26 to another vertical component 24. A single hair 28 enters the internal hair housing chamber 30 through one distal opening 32 and exits chamber through another distal opening 32. Placing hair 28 will preferably involve inserting one strand into one distal opening 32 and passing it through a loop-shaped internal hair placement chamber to then exit through another distal opening 32 until those outside sections of hair will not differ in length by approximately 12 mm. A small amount of adhesive is then placed on the longer outer portion of hair just above the distal opening, and the adhesive portion of hair is pulled into the inner hair chamber (approximately 12 mm) so that substantially equal lengths of hair remain on the outside. The adhesive is allowed to set, which helps secure or secure the hair within the internal hair housing chamber.

[00265] Each vertical component preferably has a circular or oval cross-sectional shape. Adjacent vertical components may combine with the bridges to form a variety of corresponding configurations, including the alphabetical configurations discussed above. Thus, for example, nearby vertical components can be parallel to each other, and in combination with a bridge can form an "H" shape. Alternatively, adjacent vertical components may be angled relative to each other such that they diverge distally to produce a "W" or "V" shape. An "A"-shaped anchor can be achieved when adjacent vertical components are angled relative to each other such that they diverge proximally.

[00266] The vertical components and their bridges form channels. A canal is called "open" if it is not completely demarcated along its entire length, and is called "closed" if it is open only at the ends.

[00267] The outer surface of the armature does not need to be completely smooth or straight. Non-limiting examples of external surface variations within the scope of the invention are illustrated by means of FIGS. 6A-6D in the context of the "A" shaped armature embodiment. Variations of the outer surface within the scope of the invention include, but are not limited to, sloping the vertical component distally, first upward, then downward or only downward sloping (groove 66), a depression 52 in the middle portion of the vertical component, a widening of the vertical component distally. proximally (most clearly seen in FIG. 6A), a bulbous shape 54 of the proximal portion of the vertical component, and rounded edges on all portions of the anchor surface.

[00268] Open channels 44 are further examples of outer surface design features. Open and continuous channels promote a clear fracture of the implant, resulting in the formation of 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.

[00269] In some embodiments, the anchor may have an outer recess 52 located in the mid-longitudinal region on both lateral sides (Fig. 6B).

[00270] In FIG. 7 shows an embodiment comprising a recess 52 and a recess 66. The recess 52 and recess 66 may be described by the diameter of a circle and the central angle of the circular arc. The diameter of the circle is preferably in the range of 100 µm to 75 mm or 1 mm to 50 mm, and the central angle of the circular arc is preferably in the range of 1 degree to 180 degrees.

[00271] In FIG. 10A and 10B show alternative embodiments of the implant 20 having dimples 52 located in the mid-longitudinal region on both lateral sides, dimples 66 in the region of the distal end of the anchor 22, and three or four hairs 28. Preferably, each vertical component 24 includes only one internal hair housing chamber 30, regardless of the amount of hair contained therein, such that the implant 20 has two internal hair housing chambers 30, one on each side of the break line (except for the loop-shaped internal chamber embodiment). hair placement described above and shown in Figure 2C).

[00272] In FIG. 9 shows another design feature of the outer surface in that 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, midline U-shaped recess, for which description Concepts such as arc and circle are not applicable.

[00273] In FIG. 11 shows another embodiment of the implant in accordance with the present invention, which contains two vertical components 24 connected by a jumper 26, and one continuous channel 42.

[00274] In FIG. 15A - 15E and 16A - 16D show additional embodiments of an implant anchor 20 that includes a single internal hair housing chamber 30, and either two proximal ends 40A/40B (FIGS. 15A - 15E) or one proximal end 40 (FIGS. 16A - 16D).

[00275] As most clearly shown in FIG. 15A and 15C, the implant anchor 20 includes a single anchor body 24 having a centrally located inner chamber 30 for housing hair. The lower end of the anchor body 24 contains an open channel 44, thereby forming two proximal ends 40A and 40B of the anchor body 24. In the vicinity of the bridge 26 connecting these two proximal ends 40A/40B in the region of the blind end of the open channel 44, there are corresponding parallel continuous channels 42A and 42B. As can be most clearly seen in Fig. 15B, the outer front and rear surfaces of the armature 20 include corresponding connecting surfaces 27A and 27B between the sides of the armature body 24. In FIG. 15D shows two rounded proximal ends 40A and 40B and, FIG. 15E shows one strand of hair 28 located within the centrally located inner hair housing chamber 30 and protruding from a distal opening 32 at the distal end 34.

[00276] In FIG. 16A - 16D depict an implant anchor 20 that also utilizes a single inner chamber 30 to accommodate hair, but which includes a single proximal end 40. As most clearly shown in FIG. 16A and 16C, the proximal end 40 contains a single closed channel 42. In FIG. 16C illustrates one strand of hair 28 located within the centrally located inner hair housing chamber 30 and protruding from a distal opening 32 at the distal end 34.

[00277] Consistent with all other implant anchor embodiments, the anchor varieties described in FIG. 15A - 15E and 16A - 16D contain similar materials and utilize open and continuous channels to allow the collagen junction to grow after subcutaneous implantation, to accommodate and retain collagen junctions capable of anchoring a hair strand to a hair implant recipient. As is the case with all other implant anchor options that have channels, open and/or solid channels can also define a fault line, as discussed above.

[00278] In FIG. 17A - 17D show another variation of an implant anchor 20 that utilizes a pair of internal hair housing chambers 30 and a plurality of parallel solid channels 42 with parallel open channels at a distal end 34 and a proximal end 40. Specifically, the implant anchor 20 shown in FIG. . 17A and 17C, comprises a plurality of solid channels 42 (eg, three solid channels), each of which is separated by a bridge 26 and vertically aligned along the central portion of the armature housing 24. An open channel 44 is present at the distal end 34 and at the proximal end 40. The bridges 26 are oval in shape, as most clearly shown in FIG. 17D. As most clearly shown in FIG. 17C, on each side of the longitudinal axis of the anchor body there is a hair housing chamber 30 that is oriented vertically, and each chamber 30 has a distal opening 32 at one end as well as a proximal blind-terminating portion 38 at the other end; these vertically oriented chambers 30 are parallel to the vertical side walls shown in FIG. 17C. These vertically oriented hair chambers 30 are also referred to as "straight" chambers because if their center lines are extended, they will not intersect.

[00279] Consistent with all other implant anchor embodiments, the anchor embodiments described in FIG. 17A - 17D contain similar materials and utilize continuous channels to allow the collagen junction to grow after subcutaneous implantation, to accommodate and retain collagen junctions capable of anchoring a hair strand to a hair implant recipient. As is the case with all other implant anchor options that have channels, open and/or solid channels can also define a fault line, as discussed above.

[00280] In FIG. 18 shows another variation of an implant anchor 20 that utilizes a pair of internal hair housing chambers 30 and a plurality of parallel solid channels 42, but does not have parallel open channels at the distal end 34 and proximal end 40. Specifically, the implant anchor 20 shown in Fig. 18 contains a plurality of solid channels 42 (eg, five solid channels), each of which is separated by a bridge 26 and vertically aligned along the central portion of the armature housing 24. On each side of the longitudinal axis of the anchor body there is a hair housing chamber 30 that is parallel to the side of the hair implant 20, and each channel 30 has a distal opening 32 at one end as well as a proximal blind terminating portion 38 at the other end. These hair housing chambers 30 are also called "intersecting" chambers because if their center lines are extended, they will intersect. By way of example only, the top three continuous channels may be identical in size (e.g., 100 μm in width and 200 μm in length), while the two channels below are larger in size, for example, the fourth continuous channel 42 from the top may be larger in size ( for example, 200 μm in width and 400 μm in length), while the lowermost solid channel 42 may have an even larger size, for example, 300 μm in width and 500 μm in length.

[00281] Because the distal end 34 of the implant anchor is smaller in size than the proximal end 40 of the implant, the sides of the anchor body 24 are not vertical, but rather slope or taper in an outward direction from the top (i.e., distal end 34) to the bottom parts (i.e. to the proximal end 40). Essentially, the sides of the anchor body are "sloping" or "tapering". The hair housing chambers 30 are parallel to these sides, thus "intersecting" as described above.

[00282] Consistent with all other implant anchor embodiments, the anchor embodiment described in FIG. 18 contains similar materials and utilizes solid channels to allow the collagen junction to grow after subcutaneous implantation, to accommodate and retain collagen junctions capable of anchoring a hair strand to a hair implant recipient. As is the case with all other implant anchor options that have channels, open and/or solid channels can also define a fault line, as discussed above.

[00283] In FIG. 19 shows another variation of an implant anchor 20 that utilizes a pair of internal hair housing chambers 30 and a plurality of upwardly angled anchor projections 70. In particular, the projections 70 extend from the vertical armature body 24 along its entire length and project upward at an angle to the distal end 34 in a "tree-like" manner. The projections 70 assist in anchoring the hair strand into the scalp of the hair implant recipient. The anchor has a continuous channel 42, but does not have open channels at the distal end 34 and at the proximal end 40. As with all other embodiments of the invention shown in the drawings, channels, projections, channels in projections and other design features may be added or removed from those shown (or not shown) in the drawings to provide modified versions of the embodiments shown.

[00284] In FIG. 20 shows another variation of an implant anchor 20 that utilizes a pair of internal hair housing chambers 30 and a plurality of lateral anchor projections 70 and a solid channel 42, but lacks open channels at the distal end 34 and proximal end 40. In particular, this embodiment has as a design feature, projections 70 that protrude perpendicularly from the armature housing 24. The protrusions 70 form a "cross" configuration due to the manner in which the protrusions 70 intersect with the armature body 24.

[00285] In FIG. 21 shows another variation of an implant anchor 20 that utilizes a pair of internal hair housing chambers 30, a plurality of downwardly angled anchor projections 70, and no open or closed channels. In particular, the projections 70 extend from the armature body 24 along its entire length and project downwardly at an angle from the proximal end 40 in such a way as to resemble a rocket stabilizer.

[00286] Consistent with all other armature embodiments, the armature embodiments described in FIG. 19-21 contain similar materials and utilize solid channels (shown in FIGS. 19-20) and projections to allow the collagen junction to grow after subcutaneous implantation to accommodate and retain collagen junctions capable of anchoring a hair strand to a hair implant recipient. As is the case with all other implant anchor options that have channels, open and/or solid channels can also define a fault line, as discussed above.

[00287] In FIG. 22A and 22B show another embodiment of the implant anchor 20. In particular, in FIG. 22A shows an implant having a cruciform configuration 22A with two hair element placement arms 24A and two anchor arms 24B. The hair receiving sleeves 24A include respective distal ends 34, and the anchor sleeves 24B include corresponding proximal ends 40. Each hair receiving sleeve 24A includes internal hair receiving chambers 30 with proximal blind ending portions 38, distal openings 32, and wherein each chamber 30 contains one hair 28. In addition, the implant anchor contains one continuous channel 42, which is located at the central point 43.

[00288] In FIG. 22B is a partial perspective view of the distal end 34 of one of the hair element receiving arms shown in FIG. 22A. The cross-section illustrates two hairs 28 protruding from two distal openings 32.

[00289] Consistent with all other armature embodiments, the armature embodiment described in FIG. 22A and 22B, comprises similar materials and employs solid channels to allow the growth of a collagen bond after subcutaneous implantation to accommodate and retain collagen bonds capable of anchoring a hair strand to a hair implant recipient. As is the case with all other implant anchor options that have channels, open and/or solid channels can also define a fault line, as discussed above.

[00290] In FIG. 23 shows another embodiment of an implant anchor 20 that utilizes an inverted Y-shape configuration 22B having a single hair element placement sleeve 24A and two anchor sleeves 24B. The hair receiving sleeve 24A includes internal hair receiving chambers 30 with proximal blind-terminating portions 38 and openings at the distal end 34 of the hair receiving sleeve 24A. More specifically, the implant anchor 22B is shaped like an inverted "Y". The continuous channel 42 is located at the central point where the sleeves 24A and 24B are connected.

[00291] In FIG. 24 is a perspective view of yet another embodiment of the invention of an implant anchor 20 that utilizes two internal hair housing chambers 30 with proximal blind termination portions 38 and distal openings 32 of the vertical anchor body 24. Below the internal hair chambers on the vertical component there is a solid channel 42, which is surrounded on all sides by two bridges 26 above and below the solid channel. Projecting from the proximal end 40 are four curved projections 70 that curve upward toward the distal end of the anchor. The anchor 22 generally resembles a "fishhook" or engaging structure of the anchor body 22 C, with each of the curved projections 70 spaced radially 90 degrees from the other projections.

[00292] In FIG. 25 shows yet another embodiment of an implant anchor 20 that utilizes a plurality of equally spaced "cup" structures 71 surrounding the anchor body, with recesses 52 facing the distal end 34 of the anchor body and bulges 72 extending downward toward the proximal end 40 of the anchor body. In particular, the armature body has as a design feature two continuous channels 42 aligned vertically along the central axis of the armature body 24. This embodiment also has as a design feature two internal chambers 30 for accommodating hair with proximal blind ending sections 38 and distal openings 32.

[00293] In FIG. 26 shows another embodiment of an implant anchor 20 that utilizes a vertical anchor body 24 with a “helical” anchor configuration 22G, the anchor body being helically encircled by threads 76. The pitch ratio of the threads 76 is preferably from 1 to 5, with the pitch ratio in the context of this specification is defined as the diameter of the armature body (not including threads) divided by the distance along the longitudinal axis of the armature body between adjacent thread profile vertices (i.e., the height of one complete rotation of the helical thread). Two internal hair housing chambers 30 having proximal blind ending portions 38 are exposed to the outside by two distal anchor openings 32. Near the proximal end of the anchor, two bridges 26 are vertically aligned with the solid channel 42.

[00294] In FIG. 27 shows another embodiment of an implant anchor 20 that utilizes two internal chambers 30 to accommodate hair that extend from distal openings 32 and have proximal blind ends 38. The anchor 22D resembles a racket and has a plurality of projections 70 extending laterally from the most distal "head" part of the anchor body, without such projections on the "handle" part proximal to the "head" part. A solid channel 42 is located proximal to the internal hair housing chambers, and is centrally aligned on the anchor body 24.

[00295] Consistent with all other armature embodiments, the armature embodiments described in FIG. 23-27 contain similar materials and utilize continuous channels and protrusions (i.e., projections, depressions, etc.) to allow the collagen junction to germinate after subcutaneous implantation, to accommodate and retain the collagen junctions capable of anchoring strands of hair to the hair implant recipient. As is the case with all other implant anchor options that have channels, open and/or solid channels can also define a fault line, as discussed above.

[00296] In FIG. 28 shows another embodiment of an implant anchor 20 that utilizes a horizontal anchor body 74 having a bar-shaped anchor configuration 22E with a plurality of distal holes 32 arranged in a grid pattern on the top surface 34A of the bar-shaped pattern that defines the distal end of the implant anchor. Specifically, each distal opening is an opening into an internal hair chamber 30 that contains hair 28. Four continuous channels 42 are located between each pair of adjacent hair chambers 30. Thus, twelve parallel solid channels 42 extend across the entire width of the armature between the hair receiving chambers 30, and four parallel continuous channels 42 extend across the entire length of the armature between the hair receiving chambers 30.

[00297] In FIG. 29 shows yet another embodiment of an implant anchor 20 having an irregular spherical or ovoid configuration 22F and which utilizes a plurality of internal hair housing chambers 30, each containing one hair 28 that protrudes from a distal opening 32 on a curved distal surface 34B of the anchor 22. More specifically, the anchor body 24C is ovoid or egg-shaped, with the curved distal surface 34B of the anchor being wider in width than the proximal bulbous shape 54. A solid channel 42 is located below the proximal blind-terminating portions 38 of the inner chambers 30 for accommodating hair and aligned with the central axis on the armature body.

[00298] Consistent with all other armature embodiments, the armature embodiments described in FIG. 28-29 contain similar materials and utilize channels to allow collagen junctions to grow after subcutaneous implantation to accommodate and retain collagen junctions capable of anchoring a hair strand to a hair implant recipient. As is the case with all other implant anchor options that have channels, open and/or solid channels can also define a fault line, as discussed above.

[00299] In FIG. 30 shows an embodiment of a completely monolithic hair implant product in which hair 28 forms the distal end 34 of the product. More specifically, the hair element 28 is made of the same material as the armature body 24 itself. The anchor body 24 includes a distal end 34 and a proximal end 40. The anchor has a plurality of parallel continuous channels 42, each of which is separated by a web 26 and vertically aligned along the central portion of the anchor body 24. The open channel 44 is aligned with a central axis at the proximal end.

[00300] In FIG. 31 shows yet another embodiment of the invention as a fully monolithic hair implant article in which a plurality of hairs 28 are formed at the distal end 34 of the anchor 22 from the body 24 itself. The open channel 44 is aligned with a central axis at both the distal end and the proximal end. end 40. In addition, a plurality of parallel continuous channels 42, each separated by a bridge 26, are vertically aligned along the central portion of the armature housing 24.

[00301] In FIG. 32 shows an embodiment of an implant in accordance with the present invention in which the anchor 20 includes a plurality of distal openings 32 with open channels 44 between each distal opening. Each distal opening includes a hair element 28 that projects from the anchor. In some embodiments, the hair elements are arranged into a structure 78 that is a tuft of hair. In other embodiments, the hair elements are independently attached to one or more hairs arranged in a weave, braid, twist, roll, curl, or otherwise arranged by mechanical devices or chemical means. The hair bun structure may take a form that includes, but is not limited to, a dreadlock, braid, twist, roll, or interlocking hair structure.

[00302] Consistent with all other armature embodiments, the armature embodiment described in FIG. 32 contains similar materials and utilizes channels to allow the collagen junction to grow after subcutaneous implantation to accommodate and retain collagen junctions capable of anchoring a hair strand to a hair implant recipient. As is the case with all other implant anchor options that have channels, open and/or solid channels can also define a fault line, as discussed above.

[00303] In FIG. 33 shows another embodiment of the monolithic (or integral) hair implant of the present invention, in which the anchor 20 includes a plurality of main hair elements 28 protruding from the distal end 34 of the implant. Each main hair element is a branched hair containing at least one additional hair element 80. The additional hair element extends from the side wall or shaft of the main hair element and is permanently attached, allowing the main and additional hair elements to be molded together as one unit. In some embodiments, each main hair element, in addition to containing at least one permanent additional hair element, may also include a structure of at least one structural element 82 that is a hair extension. The pilus structures extend from the side walls or shafts of the primary and/or secondary (i.e., "branching") hair elements and serve as attachment points at which additional accessory hairs can be added and optionally removed. elements.

[00304] In FIG. 34A and 34B show yet another embodiment of the invention of an implant anchor 84 having an overall cylindrical shape 86, with the upper portion 88 tapering from a larger diameter 90 to a smaller diameter 92. A plurality of internal chambers 24 are provided to accommodate hair, each containing a single hair 96 that protrudes from a distal opening 98 on the distal surface 100 of the armature 84. A plurality of solid channels 102 and open channels 104 in columns 105 are located in the body of the anchor 84. For example, the solid channels 102 may be arranged as two vertical columns 105. A pair open channels 104 may be located at the bottom of the implant anchor 84.

[00305] In FIG. 35A and 35B show another embodiment of an implant anchor 106 similar to the embodiment shown in FIG. 34A and FIG. 34B having an overall cylindrical shape 108, with the top portion 110 tapering from a larger diameter 112 to a smaller diameter 114. Again, a plurality of internal hair chambers 116 are provided, each containing one hair 118 protruding from distal opening 120 on the distal surface 122 of the armature 106. A plurality of solid channels 124 and open channels 126 in columns 128 are located in the body of the anchor 106. For example, solid channels 124 may be arranged in two vertical columns 128. A pair of open channels 126 may be located in the lower part of the anchor 106 of the implant. In addition, a bulbous convex base portion 130 is provided, with an upper portion 132 of the base portion 130 and a lower portion 134 of the base portion 130 having substantially the same diameter. At least some of the open channels 126 and solid channels 124 may be located, or partially located, on the convex base portion 130.

[00306] In FIG. 36 shows another embodiment of the invention of an implant anchor 136, similar to the implant anchor of the embodiments shown in FIG. 34A-34B and Figs. 35A - 35B (and which may be replaced by any of them), showing a smaller number of internal chambers 138 for accommodating hair.

[00307] In FIG. 37A - 37C show another embodiment of the invention of an implant anchor 140 having a shape that corresponds to a generally rectangular body 142. This embodiment is a completely monolithic hair implant product in which a plurality of hairs 144 are formed on the distal end 146 of the anchor 144 from the body itself. Solid channels 148 are located on the sides of the rectangular body 142, and open channels 150 are located on the base part 140. The base part 140 is convex, has flat sides 156 and edges 158 having smooth radii of curvature. By way of example only, FIG. 37C shows five hair housing chambers 138 with no hair elements shown.

[00308] In FIG. 38 shows another embodiment of an implant anchor 160 comprising a cylindrical body portion 162 with a tapered top portion (also referred to as a "transition top") 164, with one end 166 of the top portion 164 having a diameter (by way of example only, 1.5 mm) , similar to the diameter of the cylindrical body portion 162 and has an opposite end (forming a distal end 168) that has a smaller diameter than one end 166. The implant anchor 160 includes a plurality of solid channels 170 that are arranged in a vertical column and spaced equally apart. from friend. An open channel 174 may be present at the base 172 of the cylindrical body portion 162. A fracture line 176 extends vertically (on either side of the implant anchor 160) between the solid channels 170, from the very top of the open channel 174 all the way to the distal end 168, and serves the purpose as previously described. namely, such that if the anchor 160 "breaks" or "fragments", the anchor 160 will likely fragment along the fracture line 176, thereby releasing the collagen connections and allowing fragments of the implant 160 to "break free" and fall out of the skin, instead of being held in it. By way of example only, the length of the cylindrical body portion 162 may be 3.5 mm, while the length of the transition top 164 may be 1 mm; The total length of the anchor 160, from the distal end 168 to the proximal end 168A, may be in the range of 4 to 5 mm. The main hair elements 178 (indicated by dark lines) extend upward from the distal end 168 in a similar manner as described in relation to FIG. 31 regarding a completely monolithic hair implant article whereby a plurality of hairs are formed at the distal end of the anchor body. The "rising" hair elements 180 originate from the main hair elements 178 at a predetermined distance 182 (for example, 1 to 3 mm) above the distal end 168, and these rising hair elements terminate at the same distance as the main hair elements 178 , as indicated by reference numeral 184. The presence of ascending hair elements makes it possible to obtain more hair per unit area to increase hair volume/density. It should be noted that the solid channels 170 are shown as rectangular channels, but in the broadest scope of the present invention, the solid channels 170 may be circular channels and have a diameter, by way of example only, of 400 μm, with the solid channel 170 having a transition vertex 164 has a diameter of only 200 microns.

[00309] Consistent with all other armature embodiments, the armature embodiments described in FIG. 30-38 contain similar materials and utilize channels to allow collagen junctions to grow after subcutaneous implantation, to accommodate and retain collagen junctions capable of anchoring a hair strand to a hair implant recipient. As is the case with all other implant anchor options that have channels, open and/or solid channels can also define a fault line, as discussed above.

[00310] Such integral hair implants are preferably formed from materials that mimic human hair. Such materials are preferably capable of producing synthetic hair having a texture, flexibility, color and dimensions that are the same or substantially similar to human hair.

[00311] Although the hair portion and the anchor portion of integral hair implants are preferably formed from the same material(s), it is within the scope of the invention to modify different portions of integral hair implants differently to provide different properties to different parts of the implant. For example, dyes and/or pigments can be selectively applied to change the color of the hair portion of the implant, and cross-linking agents can be used to selectively change the mechanical properties of desired portions of the implant.

[00312] It is also within the scope of the invention to form various portions of integral hair implants from various materials, the materials being joined to provide a substantially continuous connection between the hair portion of the implant and the anchor portion of the implant.

[00313] Preferred materials for use in the manufacture of integral hair implant embodiments of the present invention include those materials that are suitable for use in other hair and anchor embodiments discussed herein.

[00314] Non-integral embodiments of the invention described and shown in the drawings may also be provided in alternative integral embodiments.

[00315] As noted previously, the channels and protrusions of the anchor help secure the implant in the patient's body by promoting the sprouting of the collagen junction associated with the foreign body response. The protruding parts also provide mechanical resistance to removal.

[00316] The foreign body response described above also provides protection against bacteria. This collagen shell or collagen barrier will prevent bacteria that may have migrated beyond the distal area of the implant from entering the dermal or subcutaneous space of the skin.

[00317] Once the foreign body reaction has completed the formation of the collagen sheath, a tightening effect will be observed over time. This tightening is beneficial because it will enhance the grip of the collagen membrane on the implant and will also limit any gap formation between the implant and the living skin tissue and thus prevent the penetration of bacteria.

[00318] The direct contact between the implant and living skin tissue, called the interface, is a connection created through a biochemical reaction. This adhesive force will also help to attach the implant to the surrounding skin tissue, and thus help prevent the formation of entry points for bacteria to enter.

[00319] The cleanliness of the patient's scalp is also an important aspect. Maintaining a low bacterial load or number of bacteria on the scalp or anywhere where implants will be placed will be beneficial in preventing infection.

[00320] Another important aspect is the prevention of not only infection, but also inflammation not caused by microorganisms. Inflammation is a reaction to foreign materials placed in the skin, such as hair and the hair implant component silica organic rubber. This inflammatory response will naturally occur when a hair implant is placed, but it is important to design the implant to ensure that the inflammatory and immune system responses are self-limiting, resulting in chemical and physical changes, and this also applies to hair implants. Hair implant oxidation, degradation, fracture and, more importantly, subsequent tissue retention of implant fragments should be considered as potential hazards of implantation, and thus it is preferable to include safety measures in the hair implant invention to address these hazards. If oxidation and degradation of the implant occurs to a significant extent, fragmentation of the implant may occur. It is preferable to accommodate this phenomenon by including a fracture line in integral and non-integral embodiments of the hair implant of the present invention to facilitate safe completion of potential fragmentation and retention of the fragment in tissue. A fault line is a structural element of an implant that has a reduced resistance to fracture relative to the balance of the implant, so that if fragmentation occurs, it occurs along the fault line. Figure 1 shows an example of a fracture line 24, collinear with the placement of the channels 26. This vertical (or longitudinal) fracture line provided for in the design can facilitate the release of the implant from the collagen connections through the channels 26, which makes it possible to facilitate the release in this case of already two vertical fragments of the broken implant. Each fragment will contain at least one hair and a silicone structure. The break line prevents, or at least minimizes, the possibility of creating random fragments that cannot be removed from the scalp by pulling the hair. The fracture line predisposes the implant to split into two fragments. If fracture occurs, it will be easier for the hair implant to fall out since it has lost one of its key attachment mechanisms. Minimal pulling forces will allow the broken implant to be completely removed. This safety measure will significantly reduce or eliminate any remaining hair fragments or implant parts, which in turn will reduce or eliminate any acute or chronic inflammatory reactions. If the implant has been completely released or removed, the subsequent collagen sheath will disintegrate over time and the subcutaneous tissue structure will be remodeled. Additionally, once the implant is in place and the foreign body reaction is complete to form a collagen sheath around the structure, if the fragment is to be retained, the collagen sheath structure will provide ongoing protection and perform its function by surrounding the foreign body and protecting it from immune system. If an inflammatory response occurs, the body will try to release this retained fragment. This reaction will be limited to the most superficial layers of the skin (unlike the deeply implanted designs of modern hair implants deep into the tendon covering of the skull (galea aponeurotica), without a mechanism for leaving the body or releasing), covering the epidermal and dermal layers. More superficial inflammation is more likely to result in the formation of a pustule-type structure followed by the release of pus and fragments, not unlike the typical pustule formation seen in certain diseases such as acne.

IMPLANTATION TECHNIQUE

Introduction

[00321] The preferred implantation technique involves several steps, including pretreatment with antibiotics and anti-inflammatory agents, preparation of the recipient skin site, anesthesia, shaping of the recipient site, selection and placement of the hair implant, temporary fixation of the hair implant and closure of the skin with medical adhesive, aesthetic considerations, and post-procedure care with antibiotics, corticosteroids, and instructions regarding proper scalp cleansing.

Natural appearance of hair as it emerges from the scalp

[00322] Administration of antibiotics and anti-inflammatory drugs and antibacterial preparation of the recipient site are very important first steps in this process. Given that potentially thousands of hair implants will be placed with corresponding thousands of needle punctures into the skin, it is prudent to initiate drug therapy to prevent infection and hyperinflammatory response. Infection or a hyperinflammatory reaction can lead to damage to the surface of the skin or damage to the skin at the epidermal and/or dermal level. This damage can result in pitting or visible indentations at the site of the recipient site and subsequent placement of the hair implant. This type of imperfection will draw attention to the scalp, especially in certain lighting, which will highlight this pitted appearance.

[00323] Preparation of the recipient skin site involves washing the target skin site with soap and water, then applying Betadine or an acceptable surgical cleansing solution, then, after the cleansing solution has dried, wiping it with sterile alcohol. This sequence of skin cleansing with appropriate staff attire, in addition to maintaining ISO Class 4 or 5 air cleanliness in the treatment room, will eliminate or significantly reduce the number of bacteria or spores in the surgical field.

[00324] Formation of the recipient site is another important step in not only forming the opening for the hair implant, but also in minimizing the actual puncture (eg, with an appropriately sized needle) or the size of the incision (eg, with an appropriately sized scalpel), which will reduce minimize the necessary healing and possible visible signs of pitting defects in the skin. In addition, the shaped section should match the natural angle at which the hair usually emerges. This will allow the hair to naturally fall forward, to the side, or back in accordance with the patient's natural angle and thus achieve a natural-looking hairstyle. The actual process of shaping the recipient site involves a technique very similar to that currently used in hair transplant surgeries. The technique for creating the recipient site involves the use of a sterile 22-32 gauge needle, 11 or 15 gauge surgical blades, or similar instruments. The needle is used to pierce the scalp at a very specific angle and to a very specific depth, depending on the desired hair geometry and density. For example, if a patient wishes to fill the crown area of the scalp with hair implants, you may notice that there is a natural “whirlpool” pattern there. With this in mind, the needle used to pierce the skin in this area of the scalp should mimic this type of "swirling" pattern of placement. This is achieved by making needle injections at an acute angle to the surface of the skin of the scalp, located along a twisting trajectory. Then, once the hair implants are in place, they will stick out from the scalp in a swirl-like pattern. The needle insertion depth should approximately correspond to the normal follicle depth of 6 mm (in this case, to place hair on the scalp). If the hair will be placed in the eyebrow area, then the needle injections should be more superficial, approximately 3-4 mm deep, etc. Finally, the cuts made by the needle should be spaced 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 hair implant with a silicone tip, it is recommended to place implants at intervals of 3-4 mm from each other and continue placing subsequent implants in the same way for 3-4 procedures to ultimately fill the area of skin until the desired thickness is achieved.

[00325] The choice of hair implant is very important to maintain a natural appearance. For example, the hairline on the scalp has a finer diameter of hair fibers than the hair just 1.25 cm behind it. This transition from finer hair to hair with a larger diameter is common and natural. Hair with a finer fiber diameter should be selected for areas following hairlines to mimic natural hair.

[00326] The silicone-containing portion of the hair implant is surgically placed approximately 3-6 mm beneath the skin, depending on whether the hair to be restored is on the scalp, pubic region, or other parts of the body. This section of silicone-applied hair will not detract from the natural appearance of the hair implant, since the clear silicone used will be invisible to the eye and will remain mostly under the skin, while a small segment, 0.1 to 0.5 mm, will remain above the skin (or below in certain cases). embodiments) without coming into view.

Installation of hair implants

[00327] Appropriate anesthesia allows the hair implants to be correctly placed at the proper depth of placement. Anesthesia involves applying a local anesthetic such as lidocaine in a cream to the recipient site or area of skin where the hair implants will be placed. 30 minutes after the local anesthetic is applied, the area is cleaned and then an injectable form of lidocaine tumescent anesthetic solution is administered to provide local anesthesia. The anesthetic cream is applied after the area is washed with soap and water, then the anesthetic is removed, wiped with sterile alcohol, then an injectable tumescent lidocaine solution is injected into the area, followed by betadine or another type of solution, etc.

[00328] In those embodiments in which the hair is attached to the anchor in a doctor's office, hair implant clinic, or manufacturer with or without an automated process, installation of the hair implant first involves opening a sterile package with only a portion of the implant, an anchor that would require subsequent attachment of a hair component, or an anchor portion with hair already attached. If the sterile package contains only the anchor component, the package will be opened in a doctor's office or clinic and the anchors will be placed in a sterile tray. Hair related components are then added to the anchors. There are several ways to attach hair to an anchor, several exemplary embodiments of which are discussed below.

[00329] Once the hair is attached to the anchor, it is ready to be placed into the skin. You can use fine, sterile jewelry-type tweezers to grasp the hair implant by the silicone-coated area and insert it into the hole in the recipient site made by the needle. Once all of the hair implants are in place, the technician will apply a tiny drop of medical adhesive (such as cyanoacrylate or other fast-drying medical adhesive) to quickly secure the hair implant in place. This technique, using fine instruments, will minimize trauma, improve healing, and result in a more natural-looking skin surface.

Hair density and location geometry

[00330] Hair implantation techniques using very close placement of recipient sites, the recipient site with an appropriate angle of inclination, the use of thin jewelry pliers and gluing techniques to fix the hair implant will provide high density styling and appropriate geometry of the hair location.

[00331] Ensuring close approximation of the recipient sites by making very small incisions with a needle to pierce the skin of the scalp will allow for greater density of placement per hair implantation session. The angle at which the recipient area is made is critical to shaping the geometry of the hair. For example, if one wants to have a natural swirl hair pattern at the top of the scalp, a very well designed swirl pattern needs to be created to mimic the natural hair geometry.

[00332] The use of thin and delicate jewelry pliers is important when handling the hair implant itself and its correct installation. Jewelry forceps allow you to gently hold the implant, preventing damage to it, and allow you to provide an unobstructed view of the placement of the implant in the scalp, due to the fact that the forceps hold only a small part of the distal part of the implant, without interfering with a direct view of the proximal end of the implant for ease of placement in the recipient plot.

[00333] Finally, gluing the hair implant will quickly secure and temporarily secure the implant and prevent it from being pulled out prematurely. Since foreign body reaction and hair implant consolidation take 14-21 days, this temporary consolidation mechanism will prevent hair loss and loss of hair density.

[00334] FIG. 8 is a schematic top view of the scalp placement of implants 20 comprising vertical components 24, distal ends 34, distal openings 32, and hair 28. A 10 x 10 mesh is applied to the scalp skin, in which each mesh cell is a section of scalp skin measuring 1 mm x 1 mm. Each implant 20 occupies two cells in the embodiment shown in FIG. 8. Completion of this placement pattern will result in fifty implants (or follicular units) per cm2 or one hundred hairs per cm2 when the follicular units have two hairs each.

Attaching a hair implant

[00335] Recipient site formation, which is a surgical step performed by inserting a needle into the skin, is a key method to ensure that the hair implant has access and affinity with living tissue, as well as the all-important immune system response. The specified hair implant and proximity to the skin tissue will ensure the occurrence of a foreign body reaction and all the effects of anchoring (see the section related to anchoring above).

[00336] Finally, gluing the hair implant will quickly secure and temporarily secure the implant and prevent premature pullout. Since the foreign body reaction and fixation of the hair implant takes 14-21 days, this temporary fixation mechanism will prevent hair loss.

Protecting the hair implant from the immune system

[00337] Recipient site formation, which is a surgical step performed by inserting a needle into the skin, is a key method to ensure that the hair implant has access and affinity with living tissue, as well as a very important immune system response. The specified hair implant and proximity to skin tissues will ensure the occurrence of a reaction to a foreign body and the formation of a collagen membrane. Once the collagen sheath is fully formed, the foreign body response will complete its task of protecting the body by enclosing the “foreign body” with this thick collagen sheath and then shutting down the immune system response. This collagen cover provides double protection, protecting the implant from further reactions from the immune system, and protecting the body from damage by the implant (a foreign body reaction assumes that the foreign body is dangerous and thus seals it off to protect the body).

Measures to ensure the safety of hair implants

[00338] With proper antiseptic cleansing of the skin, using sterile instruments for anesthesia, shaping the recipient site and installing the hair implant, fixing the hair implant and quickly sealing the epidermal incision site with adhesive will limit bacterial penetration in the short term. Long-term safety measures related to bacterial barrier formation, adherence, and problems with breakage and retention of fragments in the body are discussed above.

[00339] This implantation method will optionally allow complete removal of the implant in some embodiments. The hair implant is placed into the scalp at the same depth as the natural hair fibers, approximately 5-6 millimeters deep (only in the subcutaneous/dermal areas where natural living hair is found). As used herein, the term "subcutaneous" is defined in its broadest sense to include the epidermal, intradermal and subcutaneous spaces, including subcutaneous fat. If it is necessary to remove a hair implant, this can be done by simple plucking (such as plucking natural hair). Thus, hair removal is a safety factor in case there is a follicle that becomes infected. It is normal for natural hair follicles to occasionally become infected, and it follows that the same risk applies to the hair implant of the present invention.

[00340] Infection and inflammation of the skin containing hair is not uncommon. Many people naturally develop inactive folliculitis, or inflammation of the hair follicles. It 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 are due to routine shaving, others due to hormonal issues or even naturally occurring bacteria, present in hair follicles and various areas of the skin. Although infection and inflammation occur naturally, and usually at a low level, the goal of hair implantation is to improve the situation compared to the observed natural occurrence of infection and inflammation in the skin containing hair.

[00341] It is expected that the incidence of skin infection and inflammation associated with implants in accordance with the present invention will be less than that observed in natural conditions. The absence of glandular organs and their secretion products will make the implant area less favorable for bacterial growth. In addition, the anchor in accordance with the present invention does not have hormonal receptors that trigger inflammatory reactions, unlike natural hair follicles.

MANUFACTURING OF IMPLANTS

[00342] The implant anchor of the present invention can be formed through a variety of different processes, including injection molding and three-dimensional printing. The anchor preferably comprises a material selected for certain characteristics such as appropriate hardness, molecular weight, cross-linking and strength. These characteristics will not only provide adequate strength to resist oxidation and fragmentation, but will also help to easily withstand the pressure forces associated with forceps-based implantation techniques. This aspect of the use of tweezers when positioning the implanted object is of significant importance mainly in hair transplant surgeries when working with living hair follicular units. Placement using tweezers can injure and crush living hair follicles, but in the case of hair implants, this risk, of course, does not exist.

[00343] Materials that are highly resistant to prolonged chemical exposure to the immune system are preferred. High strength and durability of the implant is desirable. If the hair is physically pulled out, the goal is to ensure that the entire implant is removed in one or two pieces, which will prevent it from breaking (other than at a break line) and leaving implant remnants under the skin.

[00344] Medical grade silicone is the most preferred material for forming the anchor. Other materials suitable for use in forming the 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 silicone, silicone elastomers, acrylic and other resins, plastics , polyethylene, PTFE (polytetrafluoroethylene), polyesters, polyvinyl chloride (PVC), polymethyl methacrylate (PMMA), hydrogels, etc.), ceramics (including but not limited to silicates, glass, porcelain, carbon, etc.), natural biomaterials (including bone, calcium phosphate materials, etc.) and any combinations thereof (defined herein as composite materials).

[00345] In a preferred embodiment, medical grade implantable silicone is used to manufacture the implant. The silicone material is usually in liquid form and comes in two parts. When these two parts, Part A and Part B, are mixed, a chemical reaction will occur resulting in the formation of silicone rubber. This liquid-to-solid reaction can be controlled by keeping the mixture cold to slow down the liquid-to-solid reaction and allow time for the liquid silicone to be injected into the mold. After injection into the mold, heat is applied to complete the liquid-to-solid reaction.

[00346] The casting mold preferably includes a plurality of cavities for receiving liquid to be solidified to form implant anchors. The number of cavities is not particularly limited, and in some 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 casting mold .

[00347] The dimensions of the cavity are determined by the desired dimensions of the resulting implant. In some 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.

[00348] The fluid in the cavities should preferably be free of air bubbles, voids, or the like. In certain embodiments, the armature mold comprises two plates that are used in a process that minimizes or prevents the formation of air bubbles, a first plate having a plurality of holes extending therethrough, and a second plate that spans the holes in the first plate. These two wafers are dipped into liquid silicone, with the second wafer being used to push the liquid silicone through the holes in the first wafer (like a plunger in a syringe) until both wafers come into contact with each other. Excess liquid silicone is then scraped off the surface of the first wafer to produce a casting mold having a plurality of cavities filled with substantially bubble-free liquid silicone.

[00349] In the integral hair implants of the present invention, the hair strands are formed with or as part of the anchor body using, for example, casting molds including the anchor body and hair, and/or by drawing the strands from the body anchors while it is still in an uncured state.

[00350] In non-solid embodiments, the hair strands to be inserted into the anchors are preferably pre-coated with silicone (or other binder or primary coating agent compatible with silicone, such as alkoxysilane monomers or polymers, as described in US 5,061,284 (117)) to a length of, for example, 2-10 mm, 6-8 mm or 7 mm, and allow the substance to harden. 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 projects 1 mm above the anchor and remains external to the epidermal surface after implantation. In other embodiments, the length of the coating is greater than the depth of the anchor by an amount from 0.1 or 0.5 mm to 1.5 or 2 mm.

[00351] After the coating applied to the hair strands has dried to a solid, the hair strands are placed into the liquid silicone-filled cavities of the casting mold. Each mold cavity can accommodate 1, 2, 3, 4 or more strands of hair. The mold is then heated to cure the silicone to form the implants, each containing one or more hairs. The implants are then removed from the casting mold, sterilized, and packaged for distribution and use.

[00352] In some embodiments, hair is introduced and then secured through several potential mechanisms.

[00353] In a preferred embodiment of the distal-proximal hair insertion method, adhesive is applied to approximately 6 mm of the proximal end of the hair, and the hair is then fed into the distal opening of the inner hair chamber until it reaches the proximal blind end portion of the inner hair chamber. hair placement

[00354] In a first preferred embodiment of the proximal-to-distal hair guidance method, no adhesive will be applied to the hair initially, but it will first be introduced into the proximal opening of the hair placement chamber of the vertical component, and then the hair will be pushed through until Only 6 mm of its proximal end is visible, then glue is added to this 6 mm end, and finally, the hair continues to be pulled until it is completely in the hair placement chamber.

[00355] In a second preferred embodiment of the proximal-to-distal hair guidance method, no adhesive will be initially applied to the hair, but it will first be knotted at its proximal end and then fed into the proximal opening of the knot placement chamber until until only approximately 6 mm of the proximal end of the hair is visible. Glue is then applied to this 6mm end (which will contain the nodules) and finally, the hair continues to be pulled through the hair chamber until it reaches the most distal end of the nodule chamber.

[00356] It is preferable that the opening of the hair placement chamber through which the hair will be inserted be conical in shape to make it easier for the technician to insert the hair (or, if the process is automated, then by machine) and to allow more adhesive to remain in that location for increased adhesion.

[00357] The knot chamber is an enlarged proximal end of the hair chamber configured to receive a knotted portion of hair having a larger diameter than the unknotted portion of the hair shaft. The hair placement chamber located distal to the knot placement chamber has a smaller diameter than the knot placement chamber such that the knotted portion of hair is too wide to leave the knot placement chamber and enter the hair placement chamber. The diameter of the nodule accommodation chamber is preferably 500-600 µm, and the length of the nodule accommodation chamber is preferably 500 µm to 6 mm.

[00358] In some embodiments, the vertical component has a proximal end of the outer surface having a rounded shape. The arc size is 180 degrees and the circle diameter is from 500 µm to 2 mm. If the shape is oval, then the largest dimensions of the oval will be the same.

[00359] Preferably, at least some and more preferably all of the edges of the armature are rounded. This also applies to the versions shown in the drawings.

[00360] There are many types of hair on the body, including the scalp, facial area, eyebrow area, arms and legs area, pubic area, eyelash area, etc., and the manufacturing process can be modified to produce appropriate hair implants for the area of skin in question. Thus, for example, hair implants for the eyebrow area will be smaller in size than hair implants for the scalp.

[00361] In an alternative embodiment, the final assembly of the hair implants is performed by the end user (physician, physician assistant, hair stylist, etc.). Sterile anchors are supplied to the user, who selects the appropriate hair for a given patient and procedure and attaches the hair to the anchors prior to implantation, using, for example, an adhesive suitable for bonding the hair (or artificial hair) to the anchor material. Suitable adhesives include, but are not limited to, cyanoacrylate-based adhesives.

[00362] As discussed above, the angle at which the hair strands emerge from the anchor preferably varies between implantation sites. Thus, the placement of hair strands in the cavities of the casting mold can be varied to produce implants with hair exit angles ranging from 1 to 90°. Curved, slanted, or otherwise non-straight strands of hair may also be used during the manufacturing process to achieve the same or similar effect. Thus, for example, for a strand of hair positioned at an angle of 100°, 5 mm from its proximal end could be placed in a 6 mm deep casting mold cavity such that the strand of hair emerges from the resulting anchor at an angle of 10° to the surface .

[00363] Although the present invention has been described in detail and with reference to specific examples of its implementation, it will be obvious to one skilled in the art that various changes and modifications can be made without departing from the spirit of the invention and its scope.

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List of reference items

20. Implant

22. Anchor

22A. Cross anchor

22B. Anchor in an inverted "Y" shape

22C. Meshing anchor

22D. Racket Anchor

22E. Bar-shaped anchor

22F. Ovoid Anchor

22G. Helical anchor

24. Vertical Component or Anchor Body

24A. Sleeve for placing hair elements

24B. Anchor sleeve

24C. Ovoid Anchor Corps

26. Jumper

27. Connecting surface 27A and 27B

28. Hair or hair element

30. Inner chamber for placing hair

32. Distal Hole

34. Distal End

34A. Top Surface

34B. Curved Distal Surface

36. Proximal Foramen

38. Proximal blind ending section of the Inner Chamber for placing Hair

40. Proximal End

40A. Proximal End

40B. Proximal End

42. Solid Channel (or Demarcated Free Space)

42A. Solid Channel (or Bounded Free Space)

42B. Solid Channel (or Bounded Free Space)

43. Central Point

44. Open Channel (or Open Free Space)

46. Fault Line

48. Chamber for placing Nodules

50. Knot

52. Deepening

54. Bulbous Shape of the Proximal Part

56. Epidermis

58. Dermis

60. Follicular unit

62. Follicle

64. Scalp

66. Depression

68. Round notch

70. Protruding part

71. Bowl-shaped design

72. Bulge

74. Horizontal component or armature body

76. Carving

78. Hair bun

80. Additional Hair Element

82. Structural element, which is the Hairline

84. Implant Anchor

86. Cylindrical Shape

88. Upper Part

90. Larger Diameter

92. Smaller Diameter

94. Cameras for placing Hair

96. Hair

98. Distal Hole

100. Distal Surface

102. Solid channel

104. Open channel

106. Implant Anchor

108. Cylindrical Shape

110. Upper Part

112. Larger diameter

114. Smaller Diameter

116. Hair chamber

118. Hair

120. Distal Hole

122. Distal Surface

124. Solid Channel

126. Open Channel

128. Column

130. Basic Part

132. Upper part of the Base part

134. Bottom of the Base Part

136. Implant Anchor

138. Chamber for placing Hair

140. Implant Anchor

142. Rectangular Body

144. Hair

146. Distal end

148. Solid channel

150. Open channel

152. Column

154. Basic part

156. Flat sides

158. Edges

160. Implant anchor

162. length of the cylindrical part of the body

164. transition vertex length

166. one end of the transition top

168. distal end (other end of the transition apex) of the implant anchor

168A. proximal end of the implant anchor

170. solid channel

172. implant anchor base

174. open channel

176. fault line

178. main hair element

180. ascending hair element

182. a specified distance above the distal end at which the ascending hair originates

184. length at which the main hair element and the ascending hair element end

Claims (34)

1. A hair implant suitable for subcutaneous implantation, containing: (a) an anchor containing: (i) an armature body comprising a bulbous, convex base portion, the top portion of the base portion and the bottom portion of said base portion having the same diameter; And (ii) at least one collagen housing structure that includes an open channel or a continuous channel extending through the anchor body; And (b) at least one strand of hair protruding from the distal end of the anchor body, wherein the at least one collagen housing structure is configured to allow the collagen junction to germinate after subcutaneous implantation of the hair implant so as to attach the anchor to a recipient of the hair implant, and the collagen housing structure does not contain hair. 2. A hair implant suitable for subcutaneous implantation, containing: (a) an anchor containing: (i) an armature body, the armature body being a rectangular body; And (ii) at least one collagen housing structure that includes an open channel or a continuous channel extending through the anchor body, and (b) at least one strand of hair protruding from the distal end of the anchor body, wherein the at least one collagen housing structure is configured to allow the collagen junction to germinate after subcutaneous implantation of the hair implant so as to attach the anchor to a recipient of the hair implant, and the collagen housing structure does not contain hair. 3. The hair implant according to claim 2, containing a bulbous base part having flat sides and edges having smooth radii of curvature. 4. The hair implant of claim 2, further comprising a fracture line that extends vertically between a proximal end of said anchor body to said distal end of said anchor body. 5. A hair implant suitable for subcutaneous implantation, containing: (a) an anchor containing: (i) an anchor body having a cylindrical portion and a tapered portion, wherein one end of said cylindrical portion forms a proximal end of said anchor body and one end of said tapered portion forms a distal end of said anchor body; And (ii) at least one collagen housing structure that includes an open channel or a continuous channel extending through 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 placement structure is configured to allow the collagen junction to germinate after subcutaneous implantation of the hair implant, so as to attach the anchor to the hair implant recipient, and the structure for collagen placement does not contain hair. 6. The hair implant of claim 5, wherein said at least one hair strand comprises a main hair element having a first end formed at said distal end and having a free end opposite said first end. 7. The hair implant of claim 6, wherein said main hair element further comprises at least one ascending hair element that originates from said main hair element at a distance above said distal end. 8. The hair implant of claim 7, wherein said at least one ascending hair element comprises a free end that is positioned at a distance from said distal end that is the same distance as the removal at which said free end of said main hair element element is located from the distal end. 9. The hair implant according to claim 7, wherein said distance is 1 – 3 mm above said distal end. 10. A hair implant suitable for subcutaneous implantation, containing: (a) an anchor containing: (i) an anchor body having a proximal end and a distal end; And (ii) at least one collagen housing structure that includes an open channel or a continuous channel extending through the anchor body; And (b) at least one strand of hair protruding from said distal end of the anchor body, and wherein said at least one strand of hair comprises a main hair element having a first end formed at said distal end and having a free end opposite said the first end, and wherein said main hair element comprises at least one ascending hair element which originates from said main hair element at a distance above said distal end. 11. The hair implant of claim 10, wherein said at least one ascending hair element comprises a free end that is positioned at a distance from said distal end that is the same distance as the removal at which said free end of said main hair element element is located from the distal end. 12. The hair implant of claim 10, wherein the solid channels are aligned vertically in said anchor body. 13. The hair implant of claim 12, further comprising a fracture line that extends vertically between said solid channels, from said proximal end to said distal end of said anchor body. 14. The hair implant of claim 1 or 5, further comprising a fracture line that extends vertically between a proximal end of said anchor body to said distal end of said anchor body.