WO2010131270A1

WO2010131270A1 - Manual instrument for puncturing the skin, in particular the scalp for hair transplant

Info

Publication number: WO2010131270A1
Application number: PCT/IT2009/000206
Authority: WO
Inventors: Gianpiero Nobbio
Original assignee: Gianpiero Nobbio
Priority date: 2009-05-11
Filing date: 2009-05-11
Publication date: 2010-11-18

Abstract

Described herein is a manual instrument (1) for puncturing the skin, in particular for hair transplant applications, provided with: a handle element (2) designed to be handled by a user; a supporting element (4) coupled to the handle element (2); and a cutting assembly (8, 14, 15), which is coupled to the supporting element (4) so as to be free to perform a rotation about an axis of rotation (B) and bears a plurality of tips (16) arranged according to a desired puncturing pattern about the axis of rotation (B).

Description

MANUAL INSTRUMENT FOR PUNCTURING THE SKIN, IN PARTICULAR THE SCALP FOR HAIR TRANSPLANT

TECHNICAL FIELD

The present invention relates to a manual instrument for puncturing the skin, in particular the scalp for hair transplant, an application to which the following description will make particular reference without this implying any loss of generality.

BACKGROUND ART

Techniques are known for autologous hair transplant, which envisage transplantation of hair taken from the same individual undergoing treatment .

For autologous hair transplant, a surgical method is commonly used that envisages removing from non-bald areas of the scalp, generally located in the occipital region, a certain number of hair bulbs, and then implanting the hair bulbs, thus taken, in a bald region of the scalp, according to a desired pattern. For this purpose, the region that is to undergo the implantation is previously treated so as to create a series of incisions (or holes) to obtain sites that are each to house a respective hair bulb or a certain number of bulbs, according to the techniques used.

In greater detail, common techniques for taking hair bulbs envisage cutting using a bistoury (or similar instruments of incision) of strips of scalp in regions in which hair is still present (for example, from the aforesaid occipital region) , and then cutting up of said strips manually in order to obtain a plurality of micrografts, each containing one or more hair bulbs; the micrografts are then re-inserted in the sites previously obtained by incision in the region of the scalp undergoing transplantation. An alternative technique, less invasive for the subject, envisages the use of microsurgery techniques for the extraction of single follicular units; for this purpose, a bistoury with cannula is used, configured so as to cut a small portion of tissue around the hair bulb to be extracted. This portion of tissue, together with the bulb contained therein, is then re-inserted in a desired position into the bald region of the scalp, within a site that was previously made, once again by incision.

In any case, whatever the technique used, the implant operations of hair bulbs envisage preventive execution of a plurality of incisions in the scalp in order to obtain the sites for their re-insertion. The incisions are currently made manually one at a time so that the operation of preparation of the region of skin to undergo transplant leads to a considerable expenditure of time (considering that in a single transplant session hundreds of grafts and hair bulbs can be inserted) and is extremely laborious and painful for the patient. Consequently, even high doses of anaesthetic and analgesic are usually required, and moreover the aforesaid operations can cause even considerable losses of blood.

Furthermore, it is evident that current techniques for making incisions for re-insertion of the hair bulbs cannot guarantee accurate and uniform arrangement thereof, with a consequent possible lack of uniformity in thickening of the hair during subsequent re-growth.

DISCLOSURE OF INVENTION

The aim of the present invention is to solve, either totally or partially, the problems highlighted above, and in particular to provide an instrument that will enable the aforesaid skin treatment operation preceding the step of re- insertion of the hair bulbs to be made more rapid, convenient, and accurate.

According to the present invention, a manual instrument for puncturing the skin is consequently provided, substantially as defined in claim 1.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the present invention, a preferred embodiment thereof is now described purely by way of non-limiting example, with reference to the attached drawings, wherein:

- Figure 1 is a perspective view of a manual instrument for puncturing the skin, according to an embodiment of the present invention;

- Figure 2 is a lateral cross section of the instrument of Figure 1 ;

- Figure 3 is a front view of the instrument of Figure 1;

Figure 4 is a perspective view of a spacer disk of the instrument of Figure 1;

- Figure 5 is a perspective view of a puncturing disk of the instrument of Figure 1;

- Figure 6 is a front view of the puncturing disk of Figure 5 ; and

- Figure 7 is a plan view of the puncturing disk of Figure 5.

BEST MODE FOR CARRYING OUT THE INVENTION

As will be clarified hereinafter, a particular aspect of the present invention envisages providing a manual instrument for puncturing the skin that will enable an operator to make a plurality of incisions simultaneously, the incisions being arranged in a uniform way according to a desired, repeatable, and easily configurable pattern.

In detail, and as shown in Figures 1 to 3 , a manual instrument for puncturing the skin, designated as a whole by 1, comprises a handle element 2, having a substantially cylindrical tubular shape elongated along a longitudinal axis A (which also represents a central axis of symmetry thereof) , and having a gripping portion 2a, designed to be gripped by a user, and a head portion 2b, set as a prolongation of the gripping portion 2a along the longitudinal axis A. The coupling between the head portion 2b and the gripping portion 2a may be rigid or, alternatively, telescopic (in a way in itself known and hence not described in detail herein) in order to enable a useful adjustment in length (considered along the longitudinal axis A) of the handle element 2.

The instrument 1 further comprises a supporting element 4, mechanically coupled to the head portion 2b of the handle element 2 by means of suitable retention means, for example via the use of a screw 5, and/or of an elastic pin 6, for example, made of stainless steel (see in particular Figure 2) . Alternatively, also the coupling between the head portion 2a of the handle element 2 and the supporting element 4 can be of a telescopic type (in a way in itself known and hence not illustrated herein) .

The supporting element 4 has a generically L-shaped conformation along the longitudinal axis A, with a base portion 4a in contact with the handle element 2, and a body portion 4b extending parallel to the longitudinal axis A and provided with a through hole 7 (see Figure 2) at an end thereof, opposite to the base portion 4a.

The instrument 1 further comprises a pin (or hub) 8, which engages the through hole 7 and is fixed to the supporting element 4 in such a way as to be free to rotate about an axis of rotation B, transverse (in particular perpendicular) to the longitudinal axis A. The pin 8 has a substantially cylindrical conformation extending along the axis of rotation B, on the same side with respect to the base portion 4a of the supporting element 4, and is coupled to said supporting element 4 within the through hole 7 via a bushing 9, for rotation thereof; the pin 8 is also constrained to the supporting element 4 in such a way that translation movement along the axis of rotation B is prevented. In particular, provided for this purpose is a blocking ring nut 10, which blocks the portion of the pin 8 within the through hole 7 and comes to bear upon the supporting element 4 via interposition of a spacer 11, on the opposite side along the axis of rotation B with respect to the base portion 4a. The pin 8 also has a longitudinal projection (or spline) 12, integral thereto and extending along the axis of rotation B substantially for the entire length of the same pin.

The instrument 1 further comprises a plurality of puncturing disks 14 (in Figures 1-3 six disks are illustrated, by way of example), made of metal material, for example steel, and a plurality of spacer disks 15 (seven are illustrated in Figures 1-3) , which are also made of metal material or, alternatively, of Teflon or nylon. As will be described in detail hereinafter, the puncturing disks 14 are provided with a plurality of sharp tips 16, uniformly distributed along their outer perimeter and extending radially outwards, whilst the spacer disks 15 have a flat perimetral edge, without tips. The set of the puncturing disks 14 (with the corresponding tips 16) , of the spacer disks 15, and of the pin 8 can hence be defined as a cutting assembly of the instrument 1, having the function of making the incisions in the skin.

Both the puncturing disks 14 and the spacer disks 15 are mounted on the pin 8, coaxially thereto with respect to the axis of rotation B so as to be fixed to the pin 8 during its movement of rotation; the tips 16 of the puncturing disks 14 are thus distributed about said axis of rotation B.

In particular, the puncturing disks 14 and the spacer disks 15 have a respective central opening 17 (see also the subsequent Figures 4 and 5), that is to be engaged by the pin 8, and moreover a respective first recess 18 made internally starting from the central opening 17 (and communicating therewith) , which is to be engaged by the longitudinal projection 12 of the same pin 8. In this way, the puncturing disks 14 and the spacer disks 15 cannot rotate freely, but are rendered fixed to the movement of rotation of the pin 8 about the axis of rotation B.

Furthermore, a tightening ring nut 19 secures the puncturing disks 14 and the spacer disks 15 to the pin 8, preventing their translation along the axis of rotation B and bringing the puncturing disks 14 to bear upon respective spacer disks 15; the spacer disks 15 longitudinally more external with respect to the axis of rotation B come moreover to bear one upon the supporting element 4 and the other upon the same tightening ring nut 19 so that there will be no play in the direction of the axis of rotation B between the puncturing disks 14 and the spacer disks 15.

As is shown in greater detail in Figures 5 to 7, each puncturing disk 14 has a circular perimeter, a given thickness di (for example less than a respective thickness of the spacer disks 15 and, for example, of between 0.6 mm and 1.2 mm), and an outer lateral surface, integrally extending from which are the tips 16. In the example represented in Figures 5 to 7, the tips 16 are ten in number, angularly spaced at equal distances apart about the axis of rotation B by an angle of 36°.

In greater detail, each tip 16 is constituted by a pyramid with polygonal base, in particular hexagonal base, and has two sharp edges, forming between them a cutting angle a of, for example, 24°, arranged on opposite sides along the advancing direction of the puncturing disk 14 during rotation of the pin 8.

The central opening 17 also has a circular perimeter, whilst the first recess 18 has a squared, rectangular, profile. The first recess 18 is moreover aligned to a pair of tips 16 along its longitudinal axis of symmetry, for example in a direction parallel to the longitudinal axis A.

Each puncturing disk 14 also has a second recess 20, having a shape substantially corresponding to that of the first recess 18, and angularly offset with respect to the longitudinal axis of the same first recess 18 by an angle β, of for example 18° (considering a rotation about the axis of rotation B) .

Advantageously, the puncturing disks 14 are fitted on the pin 8 in --such a way that the longitudinal projection 12 engages alternatively the first recess 18 or the second recess 20 of successive puncturing disks so that the tips 16 and the resulting incisions made in the skin are not all aligned parallel to the axis of rotation B, but arranged in twos staggered (in particular by the angle β) along the same axis. In this way, it is possible to obtain a denser and more uniform distribution of the holes for subsequent implantation, for aesthetic reasons and to obtain a closer resemblance to the natural arrangement of the hair.

In use, the instrument 1 is gripped by the user, and the supporting element 4 and the associated puncturing disks 14 and corresponding tips 16 are pressed against a portion of skin to be treated, with the longitudinal axis A of the instrument 1 set transverse to the surface of the skin (for example, substantially perpendicular to this surface) . The instrument 1 is then made to advance slowly over the portion of skin, in a transverse advancing direction with respect to the axis of rotation B (in particular orthogonal to this axis) , causing rotation of the pin 8 and of the puncturing disks 14 fixed thereto. During advance by rotation of the puncturing disks 14, the tips 16 make incisions, in turn, in the skin causing formation of corresponding incisions. Preferably, the treatment is performed by displacing the instrument 1 each time over strips of skin, which extend parallel and adjacent to each other in the aforesaid advancing direction, in the sense that, once the movement of the instrument has terminated over a first strip of skin, the instrument is shifted onto an adjacent strip and moved parallel to the path previously made over the immediately adjacent strip of skin.

The arrangement of the resulting incisions is hence uniform and depends only on the geometry and the mutual arrangement of the puncturing disks 14 and of the spacer disks 15 on the pin 8. In particular, the number of tips 16 determines the spacing between the incisions in the advancing direction of the instrument 1 over the skin, whilst the thickness of the puncturing disks 14 and of the spacer disks 15 determines the distance of separation between the incisions in a direction transverse to the advancing direction. Furthermore, the number of puncturing disks 14 evidently determines the number of incisions that are made simultaneously on the skin and the size of the strip of skin that is treated in a single "pass" of the instrument 1. In other words, the pattern of the incisions resulting from advance of the instrument 1 over the skin is altogether uniform and depends only upon the arrangement and number of the constitutive elements (amongst which puncturing disks 14, spacer disks 15, and tips 16), and hence not upon the manual skill of the user. After use, the puncturing disks 14 and the spacer disks 15 can be easily removed from the pin 8 (by release of the tightening ring nut 19) so that that they can undergo cleaning, washing, sterilization, and/or be replaced. In particular, it is advisable to provide for the periodic replacement of the puncturing disks 14 after a certain number of treatments to guarantee maintenance of a good perforation capability and cutting of the tips 16 (which with use tend to deteriorate) , and moreover it is advisable to provide for sterilization of all the parts of the instrument 1 before carrying out a new treatment with a different subject.

Furthermore, it is easy for the user to modify the area undergoing treatment, for example by removing, adding, or replacing (in the case where there are advantageously available different types of disks having different geometrical characteristics) one or more of the puncturing disks 14 and spacer disks 15.

The advantages that the instrument described affords emerge clearly from the foregoing discussion.

In particular, it enables puncturing of the skin to be performed manually with a good ease of use, with an optimal result, and in an extremely short time as compared to traditional techniques. In fact, the instrument described enables a plurality of holes to be made simultaneously on a given portion of skin, and moreover the rotation of the puncturing disks enables fast displacement of the instrument, thus obtaining in very short times an altogether uniform distribution of incisions.

The entire instrument can be washed and sterilized; in particular, the modes of assembly described of the puncturing disks on the rotation pin enables a fast and convenient disassembly thereof for the purposes of cleaning or replacement .

Furthermore, the instrument 1 can undergo a wide range of configurations and can be adapted to a wide range of uses and types of areas to be treated, it being in fact sufficient to modify for this purpose the number or conformation of puncturing disks and spacer disks.

Finally, it is clear that modifications and variations may be made to what has been described and illustrated herein, without thereby departing from the scope of the present invention, as defined in the annexed claims.

In particular, it is evident that the instrument 1 may comprise a different number of puncturing disks 14 or spacer disks 15, as likewise a different number of tips 16 may be envisaged for each puncturing disk 14 or a different geometrical conformation thereof, in any case having sharp cutting edges in the advancing direction of the instrument on the skin. For example, the tips could have a generically rectangular shape (for example, similar to that of a flat screwdriver) ; the pyramidal shape described previously is in any case advantageous in so far as, thanks to the presence of the two cutting edges, it ensures the best operation of cutting of the scalp.

From experimental tests made by the present applicant it has been verified that for hair transplant application an advantageous number of puncturing disks 14 (which can in any case be in any number greater than one) is comprised between four and ten; an advantageous number of spacer disks 15 (which can possibly be provided in a number greater than one between two adjacent puncturing disks, or else be at times omitted) is comprised between six and fifteen; an advantageous cutting angle is comprised between 24° and 55°; an advantageous number of tips associated to each puncturing disk is comprised between ten and twenty-five, in particular equal to twenty.

A different embodiment of the present invention (not illustrated) can envisage the use of a cutting cylinder coupled to the supporting element 4 and free to rotate about a hub (rotatably fixed to the same supporting element) . In this case, the cutting cylinder could present, on its outer lateral surface, a desired arrangement of tips 16 for making incisions in the skin. Basically, in this case, a single removable element would be provided (i.e., the cutting cylinder), instead of the plurality of puncturing disks 14 and spacer disks 15, with the consequence, however, of a reduction in the configurability of the puncturing instrument.

The instrument described can be used for making incisions in the skin also in other regions of the body other than the scalp, and for other applications, different from hair transplant; in particular, the instrument described, with obvious geometrical modifications can find advantageous use in any area of the body that is to be subjected to hair transplant (for example, it can be used in the region of the eyebrow) .

Claims

CIiAIMS

1. A manual instrument (1) for puncturing the skin, characterized by comprising:

- a handle element (2) designed to be handled by a user;

- a supporting element (4) coupled to said handle element (2) ; and

- a cutting assembly (8, 14, 15) coupled to said supporting element (4) so as to be free to perform a rotation about an axis of rotation (B) , and bearing a plurality of tips (16) arranged according to a desired puncturing pattern about said axis of rotation (B) .

2. The instrument according to claim 1, wherein said cutting assembly (8, 14, 15) is configured to be placed in contact with a portion of said skin and to generate, following upon said rotation, said puncturing pattern on said portion of said skin when displaced in an advancing direction transverse to said axis of rotation (B) .

3. The instrument according to claim 1 or 2, wherein said cutting assembly (8, 14, 15) comprises a plurality of puncturing elements (14) arranged side by side along said axis of rotation (B) , each bearing a plurality of said tips (16) arranged along an external perimeter thereof about said axis of rotation (B) .

4. The instrument according to claim 3, for use in hair transplant, wherein the number of said tips (16) associated to each of said puncturing elements (14) is comprised between ten and twenty-five.

5. The instrument according to claim 3 or 4 , wherein said cutting assembly (8, 14, 15) further comprises a plurality of spacer elements (15) arranged between adjacent puncturing elements (14) along said axis of rotation (B) ; said puncturing pattern being further determined by the number and dimensions of said puncturing elements (14) and spacer elements (15) .

6. The instrument according to claim 5, for use in hair transplant, wherein the number of said puncturing elements (14) is comprised between one and ten, and the number of said spacer elements (15) is comprised between six and fifteen.

7. The instrument according to any one of claims 3 to 6, wherein said handle element (2) has a longitudinal axis (A) , and said supporting element (4) has, at one end thereof opposite to said handle element (2) along said longitudinal axis (A), a through opening (7); said cutting assembly (8, 14, 15) further comprising a pin element (8) that engages said through opening (7) and is free of to rotate in said through opening (7) about said axis of rotation (B) , and moreover extends in a transverse direction with respect to said longitudinal axis (A) ; said puncturing elements (14) being coupled fixedly and coaxially to said pin element (8) during said rotation.

8. The instrument according to claim 7, wherein each of said puncturing elements (14) has a disk-like conformation and is provided with a central opening (17) for insertion of said pin element (8) , and at least one first recess (18) ; said pin element (8) being provided with a longitudinal projection

(12) , configured so as to engage said first recess (18) and constrain said puncturing elements (14) to said pin element

(8) during said rotation.

9. The instrument according to claim 8 , wherein each of said puncturing elements (14) moreover has an axis of symmetry passing through said first recess, and a second recess (20) offset by a given angle (β) with respect to said axis of symmetry; and wherein said puncturing elements (14) are mounted on said pin element (8) so that said longitudinal projection (12) engages alternatively said first recess (18) or said second recess (20) , so that tips (16) of adjacent puncturing disks (14) are not aligned along said axis of rotation (B) , but staggered according to said given angle (B) .

10. The instrument according to any one of claims 7 to 9, further comprising blocking means (10, 19) for blocking said pin element (8) with respect to said supporting element (4) , and said puncturing elements (14) with respect to said pin element (8) , designed to prevent displacements of said pin element (8) and of said puncturing elements (14) along said axis of rotation (B) .

11. The instrument according to claim 10, wherein said blocking means (10, 19) are configured to enable release of said puncturing elements (14) from said pin element (8) , and hence enable replacement, and/or washing, and/or sterilization thereof .

12. The instrument according to any one of the preceding claims, wherein said cutting assembly (8, 14, 15) is designed to be displaced on said skin in an advancing direction transverse to said axis of rotation (B) ; and wherein said tips (16) are shaped like a polygonal pyramid, and have cutting edges arranged on opposite sides of said advancing direction.

13. The instrument according to claim 12, for use in hair transplant, wherein said cutting edges are constituted by sharp edges defining between them a cutting angle (a) comprised between 24° and 55°.

14. The instrument according to any one of the preceding claims, operable for carrying out perforations of the scalp in hair transplant .

15. A method of using a manual instrument (1) for puncturing the skin according to any one of the preceding claims, comprising:

- positioning said cutting assembly (8, 14, 15) in contact with a portion of said skin to be treated; and executing a translation displacement of said cutting assembly (8, 14, 15) on said portion of skin in an advancing direction transverse to said axis of rotation (B) ; said translation displacement causing rotation of said cutting assembly (8, 14, 15) and generation of said desired puncturing pattern in said portion of skin.

16. The method according to claim 15, wherein said step of positioning comprises positioning said handle element (2) transverse to said portion of skin to be treated so that said cutting assembly (8, 14, 15) rests on said portion of skin.