This invention relates to surgical instruments and, more particularly, to a punch for extracting hair follicles from the skin.
Hair transplantation is a surgical technique that involves moving skin containing hair follicles from one part of the body (the donor site) to bald or balding parts (the recipient site).
Hair naturally grows in follicles that contain groupings of 1 to 4 hairs, and transplant techniques typically move the 1-4 hair “follicular units” from the donor site to the recipient site.
The follicles of hair are typically removed from the donor site using punches of between 0.7 mm and 1.25 mm in diameter. The punches are tubular bodies having a skin-contacting cutting edge, and are typically mounted in a tool that causes the punch to rotate as the punch is brought into contact with the donor site. Hair follicles are very easily damage during the removal process, and damaged follicles are unlikely to be successfully transplanted.
Curled follicles are extremely susceptible to damage by follicle punches and are therefore particularly difficult to extract for successful transplantation. Such follicles are curled beneath the skin and are easily cut and/or damaged by the advancing cutting edge of conventional punches as the punch penetrates the donor site's tissue.
A punch that is particularly useful for removing curled hair follicles from a donor site comprises a generally tubular body disposed about a generally longitudinal axis and having a distal cutting end region terminating distally in a plurality of distally-extending circumferentially disposed, generally prong-like members carrying distally diverging cutting edges and separated by follicle-accommodating slits. In practice, the punch is oriented during the extraction process at the donor site so that the curled hair root passes into, and is spared from the advancing cutting edge by, a slit as the punch is inserted into and penetrates the tissue. The punch may then rotated slightly so that the cutting edges cut most of the tissue surrounding the follicle without making damaging contact with the follicle. It may be noted that a rotary motion may not be necessary and, if rotation is desired, it may be in one direction or be in the form of an oscillatory rotary movement, depending on characteristics of the donor site and targeted follicle.
The foregoing insertion process may be performed manually or under machine or computer control, and with or without the aid of an ultrasonic transducer coupled to punch to impart a vibratory cutting force against the tissue. In addition, a mechanism for automatically rotating the punch may be employed, and may accordingly be coupled to the ultrasonic transducer if one is used.
These and further details of the invention will be apparent to those of ordinary skill in the art from reading a description of the currently preferred embodiment of the invention described below, of which the drawing forms a part.
The detailed description of some embodiments of the invention is made below with reference to the accompanying figures, wherein like numerals represent corresponding parts of the figures.
Referring to
The punch's generally tubular body 12 has a distal cutting end region terminating distally in a plurality of distally-extending circumferentially disposed, generally prong-like members 13 carrying distally diverging cutting edges 15 and separated follicle-accommodating slits 22. The currently preferred number of members 13 is two because a pair of such members currently appears to provide the appropriate amount of cutting around the follicle together with sufficient slit width to safely accommodate entry and protection of the follicle during the extraction process.
As illustrated in the Figures, each of the preferred prong-like members 13 has a generally convex outer surface and a generally concave inner surface substantially the same as that of the tubular body. As also illustrated in the Figures, each of the prong-like members also has a beveled cutting surface 24, 26 terminating at a cutting edge, with the bevel preferably being on the inside of the punch so that it terminates at a cutting edge on the punch's outer diameter. However, the formation of bevels on the outer surface of the punch is also possible, although not preferred, and is within the scope of the invention. It may be noted that it is currently believed that the cutting edge portion illustrated in
The bevels 24, 26 are preferably created by grinding cutting edges outwardly from the interiors of the members 13 to produce sharp cutting edges. However, the bevels can also be formed by laser cutting, waterjet or abrasivejet cutting, chemical molding, and/or other manufacturing processes without departing from the scope of the invention.
The bevels 24, 26 preferably interface at an apex of the prong-like member to provide a sharp, point-like, leading tip 25 which makes the initial penetration into the tissue that surrounds the targeted follicle, while the widening, generally semi-elliptical profiles of the prong-like members 13 cut more of the surrounding tissue as the punch is urged distally into the site. The leading tip can alternatively be a sharp rounded tip without departing from the scope of the invention.
The distal end region of the punch may be further provided with generally circumferentially-extending notch having a generally concave shape that generally circumscribes the punch's outer surface. The notch preferably extends 1-2 mm proximally from a location closely adjacent the tip of the punch. The generally concave shape serves two purposes. First, its preferred size and shape results in a wound with everted edges; as the punch enters the tissue surrounding the targeted follicle, the tissue outward of the cut expands against the concavity as it is passed by the cutting edge. When the punch is subsequently withdrawn, the tissue resumes its consequently everted shape. Second, the generally concave shape and preferred sharpening from the inside of the punch results in a cutting force that is outwardly directed away from the follicle and tissue to be extracted, deceasing the risk of damage to the follicle.
Alternatively, the punch can be provided with a flared distal end having a diameter that has a diverging inner diameter and diverging outer diameter along the last 1 mm or so, with the flared end region resulting in a preferred gap of approximately 1.25 mm between opposing tips. Gaps of great or lesser spacing may be utilized as well, depending on the subject's hair and follicle dimensions without departing from the scope of the invention.
In one preferred configuration, the shape and dimensions of the slit 22 are, as best illustrated in
The cutting edge of the punch, which preferably extends from its leading tip to the beginning of the steeply tapered portion of the slit (i.e., the interface of the proximal and distal slit segments), may be smooth or include one or more serrations. If serrations are included, it is currently preferable that there be one or two serrations, with rounded edges, although the use of sharply angled edges would not depart from the scope of the invention.
As next schematically illustrated with greater magnification at “C”, the preferred punch is inserted into the skin at the donor site in such a way that the hair enters the punch's interior while the follicle 106 passes uncut through the slit 22. As further illustrated at “D”, the punch is advanced past the follicle, which remains undamaged by the cutting edges of the punch by passing through the slit. Once the punch has penetrated sufficiently, it can be partially rotated back and forth if desired, as schematically illustrated by the arrows, resulting in an arcuate cut in the tissue substantially circumscribing the curled follicle, while the follicle itself is spared by its clearance within the slit and isolation from the cutting edges. The intact hair follicle is then removed from the donor site for subsequent transfer to the recipient site.
To penetrate the skin, the punch could be manually pressed proximally by hand. Currently, it is believed that the use of an ultrasonic transducer to apply rapid, incremental, proximally-directed cutting force pulses to the tissue via the punch offers a more precisely controllable methodology for penetrating the tissue while the punch is positioned at the donor site and oriented so as to accommodate the follicle within the slit.
Turning to
The punch illustrated in
To minimize the risk of the follicle being cut during the extraction process, the formation of the cutting edges may be limited to the first 0.060 inches (1.52 mm) or so from the distal tip 125 of the punch, so that the cutting edges pass the follicle during insertion of the punch at the donor site and any subsequent contact between the punch and follicle is not with a cutting edge. The cutting edge may however extend the entire length, or a different length, of the slits.
The gap between the prong-like members of the punch illustrated in
Turning to
The gap between the prong-like members of the punch illustrated in
As with
In some embodiments, as shown in
In some embodiments, as shown in
As shown in
As shown in
As shown in
Finally, as shown in
In some embodiments, a suction device could be either in front of, within or behind the distal end region 16 of the punch 12, up to or including prong members 13. The suction effect could be increased by increasing an internal diameter of the general tubular body of the punch 12 to achieve a Bernoulli effect either in front, within or behind the distal segment of the punch up to or including prong segments. Mechanical movement of the punch 12 to drive the into the tissue in some embodiments can be adjusted by a driver that could be rotary, oscillatory, vibratory, ultrasonic, pneumatic means. Friction between tissue and distal end region 16 of the punch 12, up to or including prong members 13, could be manipulated by polishing, lubrication, manipulation of electrostatic properties, and temperature control of the generally tubular member of punch 12.
In some embodiments, the process can be enhanced by the effect of a fluid egressing mechanism which creates a fluid plane interface between punch cutting edges 15 and the skin or tissue of the patient. The purpose of the fluid egressing mechanism is to wet the grafts during scoring as well as to flush out grafts or debris impacted inside the punch or generally tubular body.
As shown in
Regardless of the specific version of follicle punch utilized, the inclusion of an ultrasonic transducer coupled to the punch and selectively operable to enhance the cutting operation is desirable. The transducer is mounted within a handpiece to which the punch is attached in a manner analogous to the transducer, handpiece and scaler tip of an ultrasonic dental scaler. The punch may be further mounted for reciprocating pivoting movement within the handpiece so as to move in such manner with or without ultrasonic vibratory movement. Likewise, the configuration may be such that ultrasonic vibratory movement can be generated with or without the pivoting movement.
In practice, it has been found that an adjustable degree of longitudinally reciprocating ultrasonic movement is desirable in that the appropriate degree of movement is a function of the subject's skin thickness and tissue, with higher settings being suitable when cutting through thicker skin or scar tissue for example. The use of the ultrasonic movement permits the surgeon or other operator of the equipment to better use his/her “fine motor” muscle movement to more precisely make the required incisions with greater sensitivity and finesse.
Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as will be defined by appended claims.
This application is a continuation-in-part of U.S. non-provisional patent application Ser. No. 15/949,357 filed on Apr. 10, 2018 (“the '357 Application”). The '357 application is a continuation of U.S. non-provisional patent application Ser. No. 14/387,984 filed on Sep. 25, 2014 which issued as U.S. Pat. No. 9,987,038 (“the '038 patent”). The '038 patent is a nation stage entry of PCT Application US2013/071991 filed on Nov. 26, 2013 (“the '991 application”). The '991 application claims priority to provisional patent application U.S. Ser. No. 61/874,664 filed on Sep. 6, 2013 and to provisional patent application U.S. Ser. No. 61/729,733 filed on Nov. 26, 2012. The entire contents of all applications listed in paragraphs 0001-0004 is herein incorporated by reference.