WO1996006566A1

WO1996006566A1 - Hair transplantation apparatus and methods

Info

Publication number: WO1996006566A1
Application number: PCT/US1995/010678
Authority: WO
Inventors: James E. Arnold; Douglas B. Dority
Original assignee: Arnold James E; Dority Douglas B
Priority date: 1994-08-31
Filing date: 1995-08-22
Publication date: 1996-03-07
Also published as: AU3539095A

Abstract

The invention provides methods and apparatus for the surgical transplantation of hair. According to one particular aspect of the invention, a method is provided for transplanting a single hair micrograft in a patient's scalp. According to the method, a spear-shaped blade (12) is pressed into the scalp to form an incision (42) having a length that is less than 2 mm, and a width that is less than 0.7 mm. A single hair micrograft is then placed in the incision.

Description

HAIR TRANSPLANTATION APPARATUS AND METHODS

BACKGROUND OF THE INVENTION The invention provides apparatus and methods for hair transplantation, and in particular to the formation of incisions for receiving small grafts of hair. For many individuals, hair loss can be undesirable or even traumatic. For such individuals, many hair replacement alternatives have been proposed including wigs, hair pieces, and more recently hair transplants. To some individuals, the hair transplant alternative is particularly desirable because living hair can be used to cover bald areas. As methods for hair transplantation continue to improve, this hair replacement alternative is becoming more widely accepted. In a typical hair transplantation procedure, grafts of skin containing hair are removed from the individual and are transplanted to other areas. To place the grafts into these areas, a number of incisions are made in the scalp. The incisions are then cleaned and a graft is inserted into each incision. When placing the grafts into the incisions, the surgeon attempts to arrange the grafts so that the resulting transplant resembles a normal hairline. To accomplish such a task, it is desirable in some cases to place only a small number of hairs, i.e. 2 to 6, often referred to as a minigraft (or even a single hair, referred to as a micrograft) into the incisions. Over the years, a variety of techniques have been employed to transplant minigrafts. In one attempt, the use of a dilator has been proposed. According to this method, an 18 or 20 gauge hypodermic needle is employed to form an incision. A dilator is then placed in the incision to dilate the incision. After removal of the dilator, the minigraft is inserted. Over time, the incision shrinks so that the skin will support the graft. However, until the incision shrinks, the graft is unstable and can be displaced. In other proposed methods, punches have been employed to punch a small diameter hole in the scalp. The graft is then placed in the cylindrical opening left by th punch. In yet another proposed method, a #11 blade (a Lan blade) has been employed to form an incision for receiving minigraft. Since the Lancet blade is angled, this method includes the additional step of translating the blade down at an angle of 45^* after the initial insertion so that the bottom of the incision has a constant depth. Having a constant depth is desirable so that the hair follicles in graft will all be transplanted at the same depth. In a similar procedure, the use of a No-Kor vented needle (Bect Dickinson and Co, Rutherford, New Jersey) has been propose for creating incisions for receiving 1 to 3 haired minigra Such a method is described in, Dominic A. Brandy and Micha

Meshkin, Utilization of No-Kor Needles For Slit-micrograft J Der atol Surg Oncol, 20:336-339 (1994).

One problem associated with the above procedures how to control the depth of the incisions. Usually, this done visually by the surgeon when inserting the blade or punch. However, such constant visual inspection is both t consuming and tedious to the surgeon. Although the Lancet blade is angled to allow easier visual identification of t depth of the cut, use of such a blade still requires the b to be angled downward so that the incision has a uniform depth. Such a procedure is both time consuming and inconvenient. One particular problem experienced with the of punches is that the central lumen of the punch often becomes clogged with tissue. The punch then loses its effectiveness until the tissue is removed.

It would therefore be desirable to provide a devi and method that could substantially reduce or eliminate suc problems. Such a device and method should allow the depth the incision to be easily and conveniently controlled and should not require substantial manipulation of the blade to form an incision having a constant depth. In the case of punches, the device and method should additionally allow fo the creation of a plurality of incisions without having the punch becoming clogged with tissue.

In another proposed method, a dermal punch has been employed to punch a small diameter hole in the scalp. The graft is then placed in the cylindrical opening left by the punch. Dermal punches are usually formed from a solid piece of stainless steel. The steel is machined to form a cylindrically shaped outer surface, and the distal end is bored to form a cylindrical opening in the punch. The concentric wall of the punch is then sharped at the distal end to provide a blade.

Forming the dermal punch in this manner presents a variety of drawbacks. For instance, machining the punch from a solid piece of stainless steel can be expensive. For this reason, it is often desirable to reuse the punch. However, since hundreds of incisions are formed in a single procedure, the blade can quickly dull requiring the punch to continually be sent to a machinist for resharpening. After a few sharpenings, the punch becomes too short for its intended use requiring disposal of the punch. One particular problem experienced when the blade dulls is that the punch becomes difficult to insert. To overcome this drawback, the punch is often rotated during incision to make penetration of the blade easier. However, the additional step of rotating the punch adds time to the procedure and can therefore be undesirable.

Another drawback to machining the punch in this manner is that it usually leaves the walls of the punch thicker than is desirable. A further drawback is that the cylindrical opening is only formed at the distal end. To allow air to be released when forming an incision, a small air hole is usually drilled through the wall of the punch and into the cylindrical opening. This can be problematic in that the cylindrical opening of the punch often fills with tissue and clogs the air hole. The punch then loses its effectiveness until the tissue is removed.

It would therefore be desirable to provide a dermal punch and methods for its manufacture and use that could substantially reduce or eliminate such problems. Such a punch should be relatively inexpensive to manufacture so that it be disposable if desired. In one aspect, the punch should have a small wall thickness, have a sharp blade, and shoul formed so that the distal end near the blade will not easi become clogged with tissue.

When performing a hair transplantation procedure, is common to transplant a large number of grafts, usually about 500 to 600, in one operation. To obtain such a larg number of grafts, it is desirable to remove the grafts fro the scalp in elongate strips (referred to as donor strips) .

The donor strips are then separated into smaller grafts ha about 1 to 6 hairs and used as transplants.

A prior art apparatus for producing donor strips shown in Fig. 36. The apparatus includes a multiple blade holder 410. The holder 10 includes a knurled cylindrical handle 412 having a distal end 14 for holding a plurality blades 424 (see Fig. 37) . The blades 424 have a planar geometry and have a sharpened edge. The blades 424 are provided with holes which are received over a pair of pins 416, 418 at the 4distal end 414. The pin 418 is thre for receiving a nut 420 which is used to secure the blades to the holder 410. From the top view, the nut 420 is rece on the right-hand side of the holder 410. Spacers 426 (se Fig. 37) are provided between the blades so that the blade are held spaced-apart from each other. In this way, a plurality of parallel blades can be held at the distal end 414. To load the blades 424 on the holder 410, the hol 410 is held in the left hand and the blades 424 and spacers 426 are placed over the pins 416, 418 with the right hand. The right hand is then used to apply and tighten the nut 42 The handle 412 includes a groove 422 for receiving the thu of the surgeon when the handle 412 is grasped.

A prior art method for using the holder 410 of Fig. 36 to produce donor strips is illustrated in Fig. 37. The holder 410 includes three blades 424 that are spaced-ap by spacers 426. Initially, a portion of a patient's head 4 is shaved to produce a uniform hair length of about 3 mm fr which the strips will be taken. The holder 410 is then grasped by a hand 430 with the thumb 432 resting in the groove 422. In this way, the hand 430 is held over the holder 410. The blades 24 are then pressed in to the patient's scalp, and the holder 10 is translated, usually in a single and continuous stroke, the length of the shaved area. This produces three parallel incisions along the patient's scalp. The skin lying within the incisions is then removed from the patient's scalp to produce two donor strips.

A serious drawback to the method illustrated in Fig. 37 is that the incisions are usually made without taking into consideration the direction of hair growth in the patient's scalp. Hair grows from the scalp in a variety of directions and varies both from patient to patient and from one area on the scalp to another. In the prior art method, the blades 424 are translated through the scalp in one continuous stroke, which severs some of the hair follicles from the hair. The grafts having these hairs cannot be used for transplantation. When making a single long sweep across the patient's scalp, a significant amount of the viable donor strip can be destroyed. In some cases it is possible to destroy up to about 80% of the viable strip. Grasping of the holder 410 in the manner shown in Fig. 37 contributes to the amount of destruction of the viable strip since such a grip requires translation of both the arm and hand and therefore makes it difficult to control the orientation of the blades when making the incisions.

It would therefore be desirable to provide methods and apparatus for producing hair transplantation donor strips with minimal or no loss of hairs in the strip when the strip is cut and removed from the scalp. Such methods and apparatus should be both efficient and easy to use. The methods and apparatus should further be able to compensate for the varied direction of hair growth in the patient's scalp when forming incisions to produce the donor strips.

SUMMARY OF THE INVENTION The invention provides a method for transplanting hair. According to the method, an instrument is provided having a shaft and a blade that is attached to the shaft so that the blade is normal to the axis of the shaft. The bla is inserted into the skin to a preselected depth that is determined by a stop disposed along the shaft. After the incision has been formed, the instrument is removed from th skin and a graft of skin having at least one hair is placed into the incision.

The invention further provides an exemplary metho for transplanting hair into a linear incision having a unif depth. According to the method, an instrument is provided with a shaft, a linear blade that is attached to the shaft normal to the axis of the shaft, and a stop disposed along shaft. The blade is attached to the shaft to form a sharpe distal edge on the shaft. The blade is inserted into the s to a preselected depth that is determined by the stop. In this way, a linear incision is formed having a length defin by the length of the blade and a uniform depth along the entire length of the incision. After forming the incision, the instrument is removed from the skin and a graft of skin having at least one hair is placed into the linear incision. Preferably, the preselected depth is less than about 6 mm.

In one particular aspect of the method, the shaft provided with two substantially parallel sides. This dista between the sides defines a thickness of the shaft. Accord to the method, the thickness of the shaft is varied to vary the thickness of the incision. Preferably, the thickness is varied in the range from about 0.6 mm to 0.65 mm. In anothe aspect, the length of the blade is varied to vary the length of the incision. Preferably, the length is varied in the range from about 1.5 mm to 2.7 mm. In yet another aspect, t preselected depth is variable and is varied by moving the st relative to the blade.

In a further step of the method, a plurality of hairs are placed into the incision. In another aspect, a plurality of incisions are formed in the skin. By keeping t stop at a constant distance between the blade, each incision will have the same depth. Alternatively, the distance betwe the stop and the blade can be varied to vary the depths of the incisions.

In a preferable aspect, engagement of the stop with the skin prevents further penetration of the blade. This is accomplished by providing the instrument with an elongate handle connected to the shaft. In this way, engagement of the handle with the skin prevents further penetration of the blade.

In an alternative method for transplanting hair, an instrument having a cylindrical shaft and a concentric blade that is attached to the shaft normal to the axis of the shaft is inserted into the skin to a preselected depth as determined by a stop disposed along the shaft to form a circular incision. Preferably, the preselected depth is less than about 6 mm. The blade is attached to the shaft to form a sharpened distal edge on the shaft. Since the blade is normal to the shaft, the resulting incision is provided with a uniform depth. The instrument is then removed from the skin, and tissue from the circular incision is removed from the patient. A graft of skin having at least one hair is then placed into the incision.

In a preferable aspect, the preselected depth is variable and is varied by moving the stop relative to the blade. In yet another aspect, a plurality of hairs are placed into the incision. In another aspect, a plurality of incisions are formed in the skin. If the stop is maintained at a constant distance from the blade, each of the incisions will have substantially the same depth.

In one particular preferable aspect, engagement of the stop with the skin prevents further penetration of the blade. Engagement of the stop with the skin can be accomplished by providing the instrument with an elongate handle connected to the shaft so that engagement of the handle with the skin prevents further penetration of the blade. In another particular aspect, a central lumen extending entirely through the shaft is provided for receiving tissue removed by the blade. Such a configuration allows for a plurality of incisions to be formed by the same instrument without having tissue accumulating near the blade to hinder the blade from forming additional incisions.

The invention provides a surgical device for form incisions that are to receive grafts of skin having hair. surgical device includes a elongate shaft having a proximal end and a distal end. A blade is attached to the distal en of the shaft normal to the axis of the shaft. The blade is attached to the shaft to form a sharpened distal edge on th shaft. A stop is disposed at a preselected distance from t blade for preventing penetration of the blade beyond the preselected distance. Preferably, the stop is disposed at distance that is less than about 6 mm from the blade.

In a preferable aspect, the stop comprises a hand that is attached to the shaft. In one particular aspect, t stop is adjustable relative to the blade so that the preselected distance can be adjusted. Adjustment of the st can be accomplished by providing an axially translatable member on the handle so that translation of the member adju the distance between the stop and the blade. In one exempl aspect, the handle can be threaded so that axial translatio of the member is accomplished by rotating the member around the handle.

In another preferable aspect, the blade is straig or linear and has a length in the range of about 1.5 mm to mm. In another aspect, the shaft is rectangular in cross section and includes at least two parallel sides to define thickness of the shaft. Preferably, the thickness in the range from about 0.6 mm to 0.65 mm.

In still another aspect, the shaft is cylindrical geometry and has an outer diameter and an inner diameter forming a central lumen. The blade is concentric in geomet is flush with the shaft to provide a sharpened distal edge the shaft. In this way, the central lumen can be used to receive accumulated tissue so that the surgical device can used to form a plurality of incisions without being hindere by the accumulated tissue. Preferably, the shaft has an op proximal end which also serves as an air hole to release ai when the blade is inserted into the skin. The invention further provides a method for transplanting a single hair micrograft in a patient's scalp. According to the method, a spear-shaped blade is pressed into the scalp to form an incision having a length that is less than 2 mm and a width that is less than 0.7 mm. A single hair micrograft is then placed in the incision. In an exemplary aspect, the incision has a length of less than 1.6 mm. In a further aspect, at least a second incision is formed within about 0.5 mm to 1.0 mm from the first incision and a single hair micrograft is placed in the second incision. Use of the spear-shaped blade is advantageous in forming the second incision in such close proximity to the first incision because the spear shape of the blade provides a convenient centering point which can be visualized by the surgeon when forming the incision.

The invention provides a surgical instrument for forming a single hair micrograft incision in the skin. The instrument includes an elongate shaft having a proximal end and a distal end. A spear-shaped blade is included on the distal end of the shaft, with the blade having a length that is less than about 1.8 mm.

The invention still further provides a surgical handle assembly that includes an elongate cylindrical sheath having a proximal end, a distal end, and a central lumen therebetween. A chuck member is slidable within the sheath lumen, with the chuck member having a proximal end and a distal end. The proximal end of the chuck is threaded, and a set of at least two prongs are disposed at the distal end of the chuck. A threaded end element is provided for mating with the proximal threaded end of the chuck member and for engaging with the proximal end of the sheath. In this way, rotation of the end element relative to the chuck member proximally translates the chuck member within the lumen to translate the prongs toward each other as the prongs engage the distal end of the cylindrical sheath.

In one aspect, the central lumen has a diameter of less than 3 mm. In another aspect, an elongate shaft is provided having a proximal end and a distal end. A spear- shaped blade is on the distal end of the shaft, with the bl having a length that is less than 1.8 mm. The proximal end the shaft is received in the prongs of the chuck member. I another aspect, an elongate cylindrical shaft is provided having a proximal end, a distal end, and an axial lumen. T shaft has a blade on its distal end, with the blade having diameter that is less than 2 mm. The proximal end of the shaft is received in the prongs of the chuck member.

In one particular aspect, at least a portion of t sheath and the end element is knurled. In this way, the prongs can be translated toward each other by grasping the sheath with one hand and the end element with the other han and rotating the end element.

The invention provides a method for forming a der punch. According to the method a hypodermic needle is provided having a concentric cylindrical shaft and a sharpe angled distal portion at a distal end of the shaft. The angled distal portion is removed from the shaft to produce rim at the distal end which is normal to the axis of the shaft. Preferably, a grinding head is rotated and position against the shaft to remove the angled distal portion. The rim is then sharpened to provide a concentric blade on the distal end of the shaft.

In an exemplary aspect, the cylindrical shaft includes an inner wall, and the rim is sharpened by reaming the inner wall adjacent the distal end. Alternatively, the rim can be sharpened by grinding an outer wall of the cylindrical shaft. In another aspect, a luer lock is mount on a proximal end of the shaft. In this way, a handle havi a male fitting can be placed into the luer lock. In yet anther aspect, the hypodermic needle is sized to have a gau in the range from 14 gauge to 22 gauge, usually having an outer diameter in the range from about 0.75mm to 3 mm, and more preferably having a diameter in the range from about 1 to 2.5 mm.

The invention further provides a method for transplanting hair. According to the method, an instrument having a thin-walled concentric cylindrical shaft and a bla on a distal end of the shaft normal to the axis of the shaft is inserted into the skin to a preselected depth. In this way, a cylindrical incision is formed in the skin. Preferably, the thickness of the wall of the shaft will be such that a clean cut can be provided when the blade is inserted into the skin, usually in the range from about 0.2 mm to 0.5 mm. The instrument is then removed from the skin, and a graft of skin having at least one hair is placed into the cylindrical incision. In one particular aspect, the instrument further includes a luer lock disposed at a proximal end of the shaft. A handle having a male fitting is then inserted into the luer lock prior to inserting the instrument into the skin.

In a particular preferred aspect, the instrument is inserted into the skin without substantial rotation of the shaft. This is accomplished by having the blade sharpened sufficiently such that the punch can be directed into the skin without requiring rotation.

In another aspect, the outer diameter of the blade is varied to vary the diameter of the incision. In still another aspect, a graft of skin having a plurality of hairs is placed into the incision, and in still a further aspect a plurality of incisions are formed in the skin.

In the method, a step is provided for removing tissue from the cylindrical incision formed by the instrument. In another step, the instrument is inserted into the skin with the shaft being substantially perpendicular to the skin at the point of incision.

In still another aspect, the method includes the step of providing suction through the concentric shaft while the shaft is inserted in the skin. Such a step is particularly advantageous in attempting to prevent tissue from being pressed or pushed under the dermis layer when the shaft is inserted into the skin. The invention provides a dermal punch which includes an elongate concentric cylindrical shaft having a proximal end and a distal end, with the wall of the shaft preferably having a thickness in the range from about 0.2 mm to 0.5 mm. A concentric blade is disposed on the distal end of shaft nor to the axis of the shaft, and a luer lock is attached to th proximal end of the shaft.

Preferably, the shaft is constructed of stainless steel. In another preferable aspect, the proximal end of t shaft is an open. This provides an air hole for relieving pressure when the punch is inserted into the skin. In stil another aspect, a handle is provided having a male fitting disposed in the luer lock. In yet another aspect, the derm punch includes means for providing suction through the concentric shaft.

A further method is provided for transplanting ha According to this method, an instrument is provided having concentric cylindrical shaft having a proximal end, a dista end, and an axis extending therebetween. A blade is on the distal end of the shaft normal to the axis of the shaft, an an escape port is provided in the wall of the shaft near th distal end. The instrument is inserted into the skin to a preselected depth where the skin is below the escape port t form a cylindrical incision. The instrument is then remove from the skin. The step of inserting the instrument into t skin is repeated, with any accumulated skin in the shaft be forced through the escape port. In this way, the shaft doe not become clogged with tissue after repeated use. A graft skin having at least one hair is then placed into at least of the cylindrical incisions.

In one aspect, the escape port is within about 5 to 10 mm of the distal end so that the port will remain abo the skin when the shaft is inserted into the scalp. In another aspect, the instrument is grasped between the thumb and at least two fingers.

An alternative embodiment of a dermal punch is provided. The punch includes an elongate concentric cylindrical shaft having a proximal end and a distal end. blade is provided on the distal end of shaft normal to the axis of the shaft. The shaft includes an aperture near the distal end having a periphery sufficiently large to allow accumulated tissue in the shaft to escape through the aperture when the distal end of the shaft is pressed into the scalp. In one aspect, the shaft is constructed of carbon steel or stainless steel, and the aperture is positioned about 5 mm or greater from the distal end. In another aspect, the aperture is elliptical in geometry, with a first axis of the ellipse having a length equal to about ninety percent of the inner diameter of the shaft, and a second axis of the ellipse having a length about five times the length of the first axis or greater. In still another aspect, a handle is provided on the proximal end of the shaft, with the handle having a length that is greater than about 3.5 cm, and preferably greater than about 4 cm. Such a length allows the surgeon to grasp the handle between the thumb and at least two fingers. In one particular aspect, an inwardly extending protrusion is provided on the shaft for engaging tissue directed into the shaft. In this way, tissue directed into the shaft during insertion passes the protrusion. When the shaft is removed from the scalp, the protrusion engages the tissue in the shaft to remove a core of tissue from the scalp. In this way, a cylindrical hole in provided in the scalp which is ready to receive a graft each time the punch is inserted.

The invention provides a further method for forming a dermal punch. According to the method, a length of steel tubing is provided. One end of the tubing is ground or reamed to produce a blade on the tubing. A hole is formed in a wall of the tubing near the blade, and the tubing is inserted into a lumen of a handle.

The invention provides methods and apparatus for transplanting hair, and in particular to the production of hair transplantation donor strips with little or no destruction of hair follicles in the strips when the strips are cut and removed from the scalp. According to one exemplary method, a surgical instrument is provided having at least two planar blades that are substantially parallel, with each blade having a sharpened edge. In one step of the method, the blades are translated along and through an area of the scalp having hair to form at least two parallel incisions in the scalp. When making the incisions, the orientation o the blades relative to the hair is adjusted such that the blades are generally aligned, i.e. substantially parallel, all times with the direction of hair growth for the hair between the blades. In this way, the incisions are made parallel to the hairs growing between the incisions so that the hair follicles are not severed from the hair when formi the incisions. A strip of skin having hair is then removed from between the incisions. At least a portion of the stri of skin having at least one hair is then placed into anothe area of the scalp.

Preferably, the entire length of skin between the incisions is removed in an elongate strip, referred to as a donor strip. If three or more blades are used to form the incisions, a plurality of donor strips are formed with a single cutting operation.

In an exemplary aspect, the instrument is grasped between the thumb and at least one finger and the finger is translated toward the wrist. While translating the finger towards the wrist, the wrist is maintained in a fixed posit relative to the scalp. In this way, the blades are transla by movement of the finger, rather than by axial translation the wrist or arm. Such a step provides improved control ov the orientation of the blades to ensure that the blades rem parallel to the direction of hair growth at all times.

In another aspect, translation of the blades is ceased after the finger has been translated toward the wris The wrist is then repositioned axially away from the incisi and the step of translating the finger toward the wrist is repeated to increase the length of the incisions formed by blades. In still a further aspect, the surgical instrument includes a groove near and generally parallel to the plane the blades. A finger is held in the groove while translati the blades. The groove serves as a reference point for the surgeon when orienting the blades relative to the scalp. T groove also provides for a constant spatial relationship between the tips of the blades and the fingers. Such a relationship is advantageous when forming incisions since t tips of the blades are hidden beneath the scalp. By knowing the location of the blade tips relative to the surgeon's fingers, the depth of the resulting incision can more precisely be controlled. In a further aspect, the groove also provides for easier gripping of the instrument.

The invention provides an exemplary surgical apparatus for forming parallel incisions in the skin. The apparatus includes an elongate shaft having a proximal end and a distal end. A plurality of parallel spaced-apart planar blades are included at the distal end of the shaft. The shaft is tapered from the distal end to the proximal end such that the center of mass of the device is near the distal end of the shaft. Centering of the mass near the distal end is advantageous in improving the control of the blades when forming an incision.

In one aspect, a groove is included at the distal end of the shaft. The groove is provided for receiving a finger when the shaft is grasped by a surgeon. Preferably, the groove is aligned in a plane that is parallel with the plane of the blades. In another aspect, the shaft is constructed of stainless steel. In still a further aspect, the shaft has a smooth exterior surface.

The invention provides an improved surgical apparatus for forming parallel incisions in the skin. The apparatus is of the type that includes an elongate shaft having a proximal end and a distal end. A plurality of parallel spaced-apart blades are held at the distal end of the shaft, with the blades being held by a threaded pin and a nut. The apparatus is improved by tapering the shaft from the distal end to the proximal end such that the center of mass of the apparatus is near the distal end, and by forming a groove in the shaft opposite the side of the shaft having the nut. In this way, a right-handed surgeon can load the blades onto the apparatus from the left hand side of the apparatus. When loading the apparatus from the left hand side, the nut will be located on the left side of the apparatus so that it will not interfere with the right handed grip of the surgeon during an operation. In one particular aspect, the groove is formed in the shape of an hourglass. Alternatively, the groove has a half round geometry, i.e. semi-cylindrical.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 illustrates a side view of a surgical devi having a linear blade according to the present invention.

Fig. 1A illustrates a front view of an spear-shap blade for forming micrograft incisions according to the present invention. Fig. IB illustrates a side view of the blade of F

1A.

Fig. 2 illustrates the surgical device of Fig. 1 rotated at an angle of 90".

Fig. 3 is a bottom view of the surgical device of Fig. 2.

Fig. 3A illustrates an alternative handle assembl for the surgical device of Fig. 1.

Fig. 4 is a side view of an alternative embodimen of a surgical device having a concentric blade according to the present invention.

Fig. 4A is a view of the surgical device of Fig. taken along lines A-A.

Fig. 4B is a view of the surgical device of Fig. 4 taken along lines B-B. Fig. 5 is a side view of a surgical device having variable stopping mechanism according to the present invention.

Figs. 6-9 illustrate an exemplary method for transplanting a graft of skin having hair using a linear incision according to the present invention.

Figs. 10-12 illustrate in greater detail the meth of Figs. 6-9 showing placement of the blade and the hair gr into the scalp.

Figs. 13-17 illustrate an alternative method for transplanting a graft of hair using a surgical device havin concentric blade. Fig. 18 illustrates a perspective view of an exemplary embodiment of a dermal punch according to the present invention.

Fig. 19 is a bottom view of the dermal punch of Fig. 18.

Fig. 20 is a perspective view of the dermal punch of Fig. 18 with a handle attached to a luer lock on the punch.

Figs. 21 and 22 illustrate an exemplary method for forming the dermal punch of Fig. 18. Figs. 23-26 illustrate an exemplary method for transplanting hair using the dermal punch of Fig. 18.

Fig. 27A illustrates a cross-sectional view of the skin showing an exemplary cut using a dermal punch.

Fig. 27B illustrates the undesirable displacement of tissue into the fatty layer when inserting a dermal punch into the skin.

Fig. 28 illustrates an alternative method for inserting the dermal punch of the present invention to help prevent the displacement of tissue into the fatty layer as shown in Fig. 27B.

Fig. 29 illustrates an alternative embodiment of a dermal punch according to the present invention.

Fig. 30 illustrates an exemplary method for grasping the punch of Fig. 29. Fig. 31 illustrates an exemplary method for using the punch of Fig. 29 in a hair transplantation procedure.

Fig. 32 illustrates a concentric cylindrical shaft of a dermal punch having an inwardly extending protrusion for engaging tissue in the shaft. Fig. 33 is a bottom view of the shaft of Fig. 32.

Fig. 34 illustrates an alternative embodiment of a concentric cylindrical shaft of a dermal punch having an inwardly extending protrusion for engaging tissue in the shaft. Fig. 35 is a bottom view of the shaft of Fig. 34.

Fig. 36 illustrates a top view of a prior art multiple blade holder. Fig. 37 illustrates a prior art method for produc hair transplantation donor strips using the apparatus of Fig. 36.

Fig. 38 illustrates a top view of an exemplary multiple blade holder according to the present invention.

Fig. 39 illustrates a side view of the holder of Fig. 38.

Figs. 40 and 41 illustrate the holder of Figs. 38 and 39, respectively, having a plurality of spaced-apart planar blades.

Fig. 42 illustrates an exemplary method for producing hair transplantation donor strips using the apparatus of Figs. 40 and 41.

Fig. 43 illustrates a cross-sectional view of hai obtained from a hair transplantation donor strip produced i accordance with the principles of the present invention.

Fig. 44 illustrates a cross-sectional view of a h transplantation donor strip produced when the incisions in scalp were not parallel with the hairs in the graft. Fig. 45 illustrates an exemplary method for formi incisions in the scalp to produce an exemplary hair transplantation donor strip according to the principles of present invention.

Fig. 46 illustrates a top view of an alternative multiple blade holder according to the present invention.

Fig. 47 illustrate the holder of Fig. 46 having a plurality of spaced-apart planar blades.

Fig. 48 illustrates an exemplary method for producing hair transplantation donor strips using the apparatus of Figs. 46 and 47.

DETAILED DESCRIPTION OF THE SPECIFIC EMBODIMENTS

Referring to Figs. 1-3, an exemplary embodiment o surgical device 10 for forming linear incisions in the skin will be described. The device 10 includes a shaft 12 and a blade 14 attached to the shaft 12. The blade 14 is a "chis type blade and is straight, i.e. is linear, along its lengt The blade 14 is "V shaped" in cross section and is attached at a distal end 13 of the shaft 12 to form a sharpened distal edge on the shaft 12. The shaft 12 is attached to an elongate handle 16 which can conveniently be provided with a gripping surface 18. Preferably, the handle 16 will have a length in the range from about 5 cm to 15 cm, more preferably at about 10 cm.

The shaft 12 and blade 14 are preferably constructed stainless steel. The shaft 12 will preferably be rectangular in cross section (see Fig. 3) and will include at least two substantially parallel walls 15, 17. The distance between the walls 15, 17 defines a thickness of the shaft 12 which will preferably be in the range from about 0.6 mm to 0.65 mm. Such a thickness is useful in forming an incision that is wide enough to receive a graft of hair. As described in more detail hereinafter, a preferable way to vary the thickness of the shaft is simply to replace the shaft. Varying the thickness of the shaft can be desirable when using the shaft to partially dilate the incision to allow easier and faster placement of the grafts.

The length of the blade 14 will preferably be in the range from about 1.5 mm to 2.7 mm. More specifically, a length in the range from about 1.5 mm to 1.6 mm is preferable for forming incisions intended to receive a single hair micrograft. Blades having a length in the range from about 1.8 mm to 1.9 mm are preferable for forming incisions for receiving minigrafts of 2 to 3 hairs, and blade lengths in the range from about 2.5 mm to 2.7 mm are preferred for forming incisions for receiving minigrafts of 3 to 5 hairs. Blades having a length of about 1.5 mm to 1.6 mm can conveniently be formed by removing the distal end of a #61 miniblade, and blades having a length in the range from about 2.5 mm to 2.7 mm can conveniently be formed by removing the distal end of a #62 miniblade. Shown in Figs. 1A and IB, is an alternative blade 19 for the shaft 12. The blade 19 will find its greatest use in the formation of incisions intended to receive single hair micrografts. The blade 19 has a length L that is less than about 2 mm, and will usually be substantially equivalent to that of a #61 miniblade, i.e. about 1.5 mm to 1.6 mm. Insertion of such a blade into the skin will form an incisi having a length of less than about 2 mm and a width of less than about 0.7 mm. The blade 19 is spear-shaped to provide sharp point 21 at its midpoint. The blade 19 is significan smaller than spear point myringotomy blades, such as those commercially available from Swan Morton, which are too larg to form acceptable micrograft incisions. Use of the spear-shaped blade 19 is advantageous in forming incisions single hair micrografts because point 21 provides for ease penetration into the skin. This allows for more rapid formation of incision and can also eliminate undesirable rotation of the blade that can sometimes occur when using a chisel type blade. The point 21 also acts as a convenient reference to allow for precise positioning of the blade pri to penetration. Such a reference is advantageous when form incisions between two previously informed incisions that ar spaced close together. For instance, the blade 19 can be u to form incisions that are within about 0.5 mm to 1.0 mm to other incisions.

Referring back to Fig. 1, the handle 16 will preferably be a conventional miniblade handle having a pair grips 20 for receiving various sized shafts. The shaft 12 inserted into the grips 20, and the handle is adjusted to clamp the shaft 12 within the grips 20. In this way, the distance between the blade 14 and the handle 16 can be adjusted. Preferably, the distance between the blade 14 an the handle 16 will be less than about 6 mm, and more preferably at about 5 mm. The grips 20 also allow for convenient use of various different sized blades so that a surgeon can tailor the size of the incision to the size of intended graft.

The diameter of the handle 16 at the grips 20 is greater than the length of the blade 14. With this configuration, the handle 16 acts as a stop when the blade and shaft 12 are inserted into the skin. The blade 14 and shaft 12 will penetrate into the skin until the handle 16 engages the skin. At this point, the handle 16 prevents further penetration of the blade 14 into the skin.

By configuring the surgical device 10 as previously described, a surgeon is able to preselect the depth of any incision. Once a depth is selected, a plurality of incisions that each have the same depth can rapidly and conveniently be formed in a patient without visually inspecting the depth of penetration when making each incision. By having the blade 14 being straight and normal to the axis of the shaft 12, each incision can be formed with a uniform depth along its length, i.e. the bottom of the incision is substantially parallel to the scalp at the point of incision. The blade 14 is able to create the incision having the desired depth that is uniform along its length in a single step. In contrast. Lancet blades require at least two steps to create an incision having both a desired depth and one that is uniform along its length as previously described.

An alternative handle 116 for the surgical device 10 is shown in Fig. 3A. The handle includes an elongate cylindrical sheath 118 having a proximal end 120 and a distal end 122. A central lumen 124 extends between the ends 120, 122. Slidable within the lumen 124 is a chuck member 126 having a proximal end 128 and a distal end 130. At the distal end 130 are at least two prongs 132. The prongs have a perimeter that is greater than the diameter of the lumen 124. In this way, when the chuck 126 is proxi ally translated within the lumen 124, the distal end 122 of the sheath 118 forces the prongs toward each other. When a shaft 134 having a blade at its distal end (not shown) is placed between the prongs 132, the shaft 134 becomes securely clamped between the prongs as the chuck 126 is drawn proximally through the lumen 124. As with the embodiment of Fig. 1, the distal end 130 of the chuck 126 functions as a stop to control the depth of blade penetration when forming an incision. To proximally translate the chuck 126, a threaded end element 136 is provided to receive the proximal end 128 of the chuck 126 which is also threaded. The end element 136 has a distal end 138 with a perimeter that is greater than the perimeter of the lumen 124. As the end element 136 is rota as shown by the arrow, the distal end 138 of the end elemen 136 engages the distal end 120 of the shaft 118. At this point, further rotation of the end element 136 proximally translates the prongs 132 relative to the shaft 118. This turn causes the prongs 132 to be translated toward each oth to clamp the shaft 134. Conveniently, portions of both the shaft 118 and the end element 136 can be knurled. This all a better gripping surface so that the shaft 118 can be gras with one hand while the end element 136 is grasped with the other.

An advantage of the handle assembly 116 is that t prongs 132 can be made long enough to hold commercially available miniblades without alteration or modification of miniblades. Most miniblades have relatively long shafts, a placement of a long shaft in the prongs 132 is desirable because it provides a more stable connection between the handle 116 and the miniblade. Prior art chucks include pro that are not long enough to receive most miniblades without modifying the miniblades by removing a proximal portion of blades, thereby reducing the stability of the blades when i the chuck.

Another advantage of the handle assembly 116 is t the end element 136 is rotated (rather than the chuck 126) clamp the shaft 134. The end element 136 provides a convenient gripping surface so that a sufficient amount of torque can be applied. Improved torque results in greater proximal translation of the chuck, and hence a tighter grip the prongs 132. A further advantage of the handle assembly 116 is that it can be fashioned to have a relatively small diameter. This is advantageous in allowing the surgeon to around the handle assembly 116 when attempting to make an incision. The smaller the handle assembly, the easier a surgeon can view both the blade tip and the target location the patient's scalp. Preferably, the central lumen will ha a diameter that is less than about 3 mm. The walls of the sheath 118 will preferably be less than about 0.3 mm. Such size provides a handle assembly 116 that is large enough to receive miniblades capable of producing incisions for receiving hair transplants having about 5 hairs or less, but small enough for a surgeon to still view the blade when performing surgery. The prongs 132 can be fashioned so that they can receive blades having different sizes and geometries. For instance, the prongs 132 can be configured to receive cylindrical blades as described hereinafter. In this manner, the handle assembly 116 can be used for a variety of surgical applications in addition to hair transplantation, including plastic and cosmetic surgery, general surgery, and the like.

Referring to Figs. 4, 4A and 4B, an alternative embodiment of a surgical device 22 will be described. The device 22 includes a cylindrical shaft 24 and a concentric blade 26 attached to the shaft 24. The shaft 24 and blade 26 form what is commonly referred to as a dermal punch. The blade 26 is attached to a distal end 32 of the shaft 24 to form a sharpened distal edge on the shaft. The cylindrical shaft 24 includes a central lumen 28 and is open both at a proximal end 30 and at the distal end 32 where the blade 26 is attached. The shaft 24 is held within a handle 34 which functions as a stop similar to the handle 16 as previously described. Preferably, the blade 26 will be distanced from the handle 34 by a distance that is less than about 6 mm, and preferably at about 5 mm. The blade 26 preferably has an outer diameter in the range from about 1.0 mm to 2.0 mm to form incisions for receiving grafts having 1 to 8 hairs. The lumen 28 in the shaft 24 is for receiving accumulated tissue from multiple insertions of the blade 26 into the skin. When forming a plurality of incisions, tissue will often build up in the distal end 32 of the shaft 24. By extending the lumen 28 through the entire length of the shaft 24, accumulated tissue can be directed through the lumen 28 upon each additional insertion of the blade 26 to the skin. This prevents the distal end 32 from clogging and increases the effectiveness of the blade 26. The shaft 24 is open at the proximal end 30 so that an air hole can be provided in the shaft 24. This provides for easier travel of the accumulated tissue through the lumen 28. Although the shaft 24 is show extending entirely through the handle 34, the shaft 24 can terminate anywhere within the handle 24. In such a case, t lumen 28 can be extended through the handle 34 so that an a hole will still be provided. For convenience, the handle 3 can be constructed of plastic or other disposable material that the device can be discarded after use.

Referring to Fig. 5, an alternative embodiment of surgical device 36 is shown. The surgical device 36 is essentially identical to the surgical device 22 of Fig. 4 except for the stopping mechanism. For convenience of discussion, the same reference numerals shown in Fig. 4 wil be used to describe Fig. 5. The surgical device 36 include an adjustable stopping mechanism that includes a rotating collar 38 that can be rotated about a plurality threads 40 provided on the handle 34. Rotation of the collar 38 translates the collar 38 axially along the handle 34 and varies the distance between the collar 38 and the blade 26. In this way, the depth of the incision can easily and conveniently be varied by simply rotating the collar 38. T collar 38 engages the skin and prevents further penetration the blade 26. Although not shown, a variety of different mechanisms can be employed to vary the depth of the incisio including adjustable clamps, slidable collars, and the like An adjustable collar similar to collar 38 can als be provided on the shaft 12 of the surgical device 10. Suc collar allows the depth of blade penetration to be varied a previously described.

The surgical device 36 is particularly advantageo when forming incisions over a variety of different areas on the scalp. Since the thickness of the scalp varies dependi on location, the depth of blade penetration can convenientl be adjusted depending on where the incision is to be made.

Referring now to Figs. 6-9, an exemplary method f hair transplantation using the surgical device 10 will be described. As shown in Fig. 6, a surgeon's hand H grasps t device 10 along the handle 16 and positions the blade 14 to desired location over the patient's scalp. As shown in Fig. 7, the blade 14 is depressed into the patient's scalp by pressing on the handle 16. When pressing the blade 14 into the skin, the handle 16 will preferably be oriented perpendicularly to the patient's scalp at the point of the incision. This allows the blade 14 (that is normal to the shaft 12 and handle 16) to produce an incision having a uniform depth along its length. Penetration of the blade 14 into the scalp is stopped when the handle 16 engages the skin. At that point, the blade 14 has reached the appropriate depth. The device 10 is then lifted from the scalp to remove the blade 14 leaving an incision 42 as shown in Fig. 8. Since the blade 14 is straight, the resulting incision 42 is linear. Having a linear incision is desirable in that it heals quickly and leaves minimal or no scarring. The incision 42 is then cleaned and a micrograft of hair 44 placed therein (see Fig. 9). Alternatively, depending on the size of the incision 42, a minigraft can be placed therein.

The process of forming the incision 42 can be rapidly repeated along the patient's hairline to form a plurality of incisions that each have substantially the same depth, and with each incision having a uniform depth along the lengths of the incisions. Each of these incisions can then have a graft of skin having hair placed therein as previously described. Referring to Figs. 10-12, formation of the incision

42 will be described in greater detail. As shown in Fig. 10, the patient's scalp includes a dermis layer 46, a fat layer 48 and a galea layer 50. The patient's existing hairs 52 are disposed in the dermis layer 46 with the follicles 54 disposed at the base of the dermis layer 46, with some extending into the fat layer 48. The blade 14 is inserted through the dermis layer 46 until it reaches or slightly penetrates the fat layer 48. At this point, the handle 16 engages the dermis layer 46 and prevents further travel of the blade 14. When the device 10 is lifted from the patient's scalp as shown in Fig. 11, the formation of the incision 42 is complete. The incision has a depth that is uniform along its entire length as previously described. As shown in Fig. 12, a graft of skin having a hair 54 is placed into the incision 42 with the follicle resting near the bottom of the incision 42. As previously describe the depth of the shaft 12 can be adjusted so that the blade will reach an appropriate depth which is preferably near wh the dermis layer 46 and the fat layer 48 meet.

Referring to Figs. 13-17, a method for transplant hair using the surgical device 22 will be described. Initially, as shown in Fig. 13, the device 22 is positioned over a patient's scalp with the blade 26 near the patient's hairline. As shown in Fig. 14, the device 22 is depressed force the blade 26 into the scalp. The device 22 is then lifted from the patient's scalp as shown in Fig. 15. In th way, a circular incision 56 is formed. Sometimes, tissue within the incision 56 will be removed by the shaft 24 when lifting the device 22 from the scalp. If not, a pair of tweezers 58 or other grasping device can be employed to rem the remaining tissue from the scalp as shown in Fig. 16. W the tissue is removed, a cylindrical hole is formed in the patient's scalp. A hair graft 60 can then be placed in incision 56 as shown in Fig. 17.

Referring to Figs. 18 and 19, an exemplary embodiment of a dermal punch 210 for forming cylindrical incisions in the skin will be described. The dermal punch includes an elongate concentric cylindrical shaft 212 havin proximal end 214 and a distal end 216. Preferably, the sha 212 is constructed of stainless steel. At the distal end 2 is a rim. A concentric blade 218 is formed at the rim and normal to the axis of the shaft. Preferably, the blade 216 formed on the inner wall of the shaft (i.e. the wall adjace the cylindrical opening in the shaft) , but can alteratively formed on the outer wall (i.e. the wall exposed to the environment) , or on both the outer wall and the inner wall. The thickness of the wall of the shaft 212 is such that the shaft 212 can easily be depressed into the scalp to provide clean cut, the thickness preferably being in the range from about 0.2 mm to 0.5 mm. Shafts having such a thickness are found in most commercially available hypodermic needles hav gauges in the range from about 14 gauge to 22 gauge. Attached to the proximal end 214 is a luer lock 220. The luer lock 220 has an open region 222 for receiving a male fitting. The luer lock 220 is preferably attached to the shaft 212 in such a manner so that the proximal end 214 of the shaft 212 is open (similar to luer locks on conventional hypodermic needles) . In this way, the entire interior portion of the shaft 212 is in communication with the air from the environment. The luer lock 220 is preferably constructed of a medical grade plastic or polymer. In one particular aspect, the luer lock 220 is used as a stop to control the depth of blade penetration into the scalp. When configured in such a manner, the length of the shaft 212 will usually be in the range from about 4 mm to 6 mm, and preferably at about 5mm. Such a length allows the shaft to penetrate through the dermis layer and to the fatty layer of the skin. Alternatively, the depth of blade penetration can be manually controlled. In such a case, the length of the shaft 212 can be much longer and can be varied to the liking of the surgeon. Referring to Fig. 20, the dermal punch 210 can be provided with a handle 224. The handle 224 includes a male fitting 226 that is received in the open portion 222 of the luer lock 220, usually by a press fit. Alternatively, the male fitting 226 and the open portion 222 can be threaded so that the handle 224 can be screwed into the luer lock 220. In one particular aspect, the handle 224 can be the body of a conventional syringe (approximately 1 cc in size) . The handle 224 provides a convenient extension on the punch 210 for easier manipulation of the punch. Preferably, both the male fitting 226 and a proximal end 225 of the handle 224 will be open to the atmosphere so as to provide a vent when the handle 224 is attached to the luer lock 220 and the blade 218 is inserted into skin. Such a configuration helps prevent skin from becoming clogged near the blade 218 during multiple uses. As described in greater detail hereinafter, the open proximal end 225 conveniently allows for suctioning of the surgical site through both the handle 224 and the shaft 212. Referring to Figs. 21-23, an exemplary method for forming the dermal punch 210 illustrated in Figs. 18 and 19 will be described. The dermal punch 210 will preferably be constructed from a conventional hypodermic needle 228 (see Fig. 21) that is sized to have a gauge in the range from ab 14 gauge to 22 gauge. Such needles usually have an outer diameter in the range from about 0.75 mm to 3 mm, and will preferably have an outer diameter in the range from about 1 to 2.5 mm. Such needles are available from a variety of commercial suppliers including Beckton Dickinson and Co. , Rutherford, New Jersey. The use of a hypodermic needle in forming the punch is preferable because such needles are relatively inexpensive as compared to punches that are machined from a solid piece of steel. Also, the wall thickness in hypodermic needles is substantially smaller th in machined punches and can provide a cleaner cut into the skin.

The hypodermic needle 228 includes an angled dist portion 230 that is removed to form the rim at the distal e 218. As shown in Fig. 21, a preferred method for removing angled distal portion is with a powered grinder 232. The grinder 232 has a rotating grinding head 234 that is direct against the shaft 212 at a 90 degree angle relative to the axis of the shaft 212 until the grinding head 234 cuts thro the shaft 212. In this way, the grinding head 234 is able remove the angle distal portion 230 without substantially disfiguring the shaft 212. Alternatively, the angled dista portion 230 can be removed by a variety of other tools and methods, a requirement being that the shaft 212 is not disfigured in the process. Such tools include saws, lathes, pipe cutters, and the like.

To form the concentric blade 218, the inner wall the shaft 212 is reamed at the distal end 218 as shown in F 23. An exemplary tool for reaming the inner walls of the shaft is a dental burr 236. The dental burr 236 is directe into the interior portion of the shaft 212 and is rotated, preferably by hand, to remove material from the inner wall form the concentric blade 218. The burr 236 is rotated unt the blade 218 is sufficiently sharp so that the blade 218 can penetrate the scalp without rotation. In the event that the blade 218 becomes dull after use, the blade 218 can be resharpened as previously described. Alternatively, since the punch 210 is relatively inexpensive to manufacture, the entire punch 210 can be disposed and a new punch employed.

Alternatively, the blade 218 can be formed on the outer wall by removing material from the outer wall. This is preferably accomplished by placing a grinding head against the outside wall of the shaft 212 at its distal end 218 and rotating the grinding head.

Referring to Figs. 23-26, an exemplary method for transplanting hair using the dermal punch 210 will next be described. Initially, the handle 224 on the punch 210 is grasped by a hand H and positioned over a patient's scalp as shown in Fig. 23. The shaft 212 is manipulated until the shaft 212 is substantially perpendicular to the patient's scalp at the point of intended incision. The blade 218 is then depressed into the scalp as shown in Fig. 24. Preferably, the blade 218 will be depressed into the scalp without rotation. This allows a plurality of incisions to be formed in a rapid manner. The blade 218 is depressed until penetrating the scalp to a depth of about 5 mm. The blade 218 is then lifted from the scalp to form a cylindrical incision 238 as shown in Fig. 25. If required, any remaining tissue in the cylindrical incision 238 can be removed by tweezers. After the incision 238 is formed, a graft of skin 240 having hair is placed into the incision as shown in Fig. 26.

As shown in Fig. 27A, the cylindrical incision 238 will preferably extend through the dermis layer 250 and into the fatty layer 252, leaving a cylindrical piece of skin 254. Usually, the piece of skin 254 will separate from the fatty layer 252 when the punch 210 is removed from the skin. Sometimes, however, the piece of skin 254 will either remain attached (as shown in Fig. 27A) or it can become lodged under the dermis layer 250 as shown in Fig. 27B. If the piece 254 becomes lodged under the skin, a variety of complications can occur including the formation of a post transplant epidermoi cyst.

To help prevent such complications, an alternative method for forming the incision 38 is provided as shown in Fig. 281. According to this alternative method, a suction source (not shown) is provided to the punch 210 via a tube 258. The tube 258 is inserted into or attached to the open proximal end 225 of the handle 224. At its other end, the tube 258 is attached to a suction machine or a house vacuum. In this way, suction is provided through both the handle 24 and the concentric shaft 212. When the shaft 212 is inserte into the scalp, the suction tends to draw the piece of skin 254 into the shaft 212 to help prevent the piece of skin 254 from lodging under the dermis layer. Appropriate filters an collecting apparatus can also be provided to trap and collec any removed skin.

An alternative embodiment of a dermal punch 300 is illustrated in Fig. 29. The punch 300 includes a concentric cylindrical shaft 102 having a proximal end 304 and a distal end 306. A blade 108 is formed on the distal end 306 and is normal to an axis of the shaft 302 extending between the proximal and distal ends 304, 306. The shaft 302 includes a aperture or escape port 310. As described in greater detail hereinafter, the port 310 in one aspect serves to allow accumulated tissue in the shaft 302 to escape so that the shaft 302 does not become clogged with tissue. In another aspect, the port 310 serves as an air hole to allow air to escape from the shaft 302 when making incisions. The port 3 is provided at a location on the shaft 302 that is sufficiently proximal from the blade 308 so that the port 30 will remain above the skin when the blade 308 is inserted in the scalp. Preferably, the port 310 is located about 5 mm o greater from the blade 308. The port 310 can be provided wi a variety of geometries, but needs to be sufficiently large that accumulated tissue can escape from the shaft 302. The port 310 will preferably be elliptical. In an exemplary configuration, a first axis of the ellipse will have a lengt that is about ninety percent of the inner diameter of the shaft 302 and a second axis will have a length that is about five times the length of the first axis or greater. Such a configuration is advantageous in allowing accumulated tissue to easily escape from the shaft 102 when forming numerous incisions in the scalp.

The shaft 302 will preferably be constructed from a length of stainless steel tubing that is cut to the proper length. Use of stainless steel tubing is advantageous because of its low cost. Alternatively, the shaft 302 can be constructed of carbon steel tubing. Use of carbon steel is advantageous in that it can easily be sharpened to a degree sufficient so that it can be punched through the skin without rotation when forming incisions.

To form the blade 308, the distal end 306 can be ground, milled, reamed, or the like. In this way, the shaft 302 can easily be resharpened and reused. Reuse of the shaft is desirable in reducing costs of the surgery. To form the port 310 in the shaft 302, the side of the tubing can be milled, ground, or the like. The punch 300 further includes a handle 312 that is preferably constructed of stainless steel and has a knurled surface. The handle 312 includes a central lumen 314 for receiving the shaft 302. The shaft 302 can be attached to the handle 312 in a variety of way such as by a press fit. In one particularly preferable aspect, the shaft 302 is removably attached to the handle 312 so that the shaft 302 can be replaced. Replacement of the shaft 302 is often necessary after several sharpenings which reduce the length of the shaft 302. By having a reusable handle, the shaft 302 can be sold as a deposable item. An exemplary handle that is reusable with different shafts as previously described.

The handle 312 preferably has a length sufficiently long so that the handle 312 can be grasped between the thumb and at least two fingers as shown in Fig. 30. Preferably, the handle 312 will have a length that is greater than or equal to about 4 cm. Such a length is longer than existing dermal punches which are designed to be grasped between the thumb and the index finger only so that the punches can be rolled between the thumb and the index finger during insertion. However, such a grip easily fatigues the surgeon's hand whe making multiple incisions. The handle 312 of this inventio allows for the punch 300 to be grasped between the thumb an at least two fingers to reduce the problems of fatigue. Th blade 308 on the punch 300 is made sufficiently sharp so th rotation of the blade 308 is not needed when making incisio thereby further reducing fatigue and operation time. Graspi of the handle 312 in this way is further advantageous in providing stability to the punch 300 and allows for easier orientation when pressing the blade 308 into the scalp. The handle 312 preferably has a diameter that is equal to or greater than about 3/16 inch to provide for a more comforta grip. An exemplary method for using the punch 100 in a transplantation procedure is shown in Fig. 31. The handle 3 of the punch 300 is grasped as previous described in Fig. 30 The blade 308 is then pressed into the scalp with the blade 308 being normal to the scalp. The blade 308 is preferably inserted without rotation. The blade 308 is then removed fr the scalp to form a cylindrical incision. Another incision then formed in the same manner. As more incisions are made, cylindrical plugs of tissue 314 from the scalp usually separate from the scalp and accumulate in the shaft 302. In typical procedure, scores of incisions are made. If the accumulate tissue is not removed, the punch 300 can become clogged and will be inoperable. In the method of the invention, such tissue is removed from the shaft during use the punch 300. As the shaft 302 is pressed into the scalp, the accumulated tissue is forced through the shaft 302 where it escapes through the port 310. In this way, a number of incisions can be made without having the shaft 302 becoming clogged with tissue. This saves time for the surgeon who ca continuously form incisions without having to slop and clear any tissue from the shaft 302 or obtain a new punch.

The dermal punch of the invention can be provided with a protrusion that extends into the interior of the shaf The protrusion is fashioned such that tissue can pass the protrusion when the punch is inserted into the scalp, but is prevented from passing back past the protrusion when the punch is removed. In this way, the cylindrical core of tissue formed by the punch is removed each time the punch is inserted. This eliminates the step of separately removing the core of tissue from the scalp after removing the punch. The protrusion is provided at or below the tissue escape port so that the removed tissue is still able to be removed from the shaft as previously described. An exemplary shaft 320 having a protrusion 322 is shown in Figs. 32 and 33. The protrusion 322 is formed by crimping the shaft 320 at a lower edge 324 of an escape port 126. An alternative shaft 328 is shown in Figs. 34 and 35. The shaft 328 has a lip or protrusion 330 that is formed at a lower edge 332 of an escape port 334. The protrusions 322 and 330 are formed such that tissue can pass by them only in the direction of the escape ports 326, 334. In this way, tissue which has passed the protrusions 322, 330 becomes engaged with the protrusions 322, 330 when the shafts 320, 328 are removed from the scalp. Further removal of the shafts 320, 328 separates the tissue from the scalp.

The invention provides methods and apparatus for transplanting hair, and in particular for producing hair transplantation donor strips from which minigrafts or micrografts can be selected. The methods and apparatus of the invention allow for the production of hair transplantation donor strips without substantial destruction of the hairs in the strip as the strip is cut and removed from the scalp. An exemplary apparatus 434 for providing such a donor strip is shown in Figs. 38 and 39. The apparatus 434 includes an elongate shaft 436 having a proximal end 438 and a distal end 440. The shaft 436 can be constructed of any rigid material, but will preferably be constructed of stainless steel. The exterior surface of the shaft 436 is preferably smooth so that the apparatus 434 can easily be cleaned. The proximal end 438 of the shaft 436 is tapered, with the proximal end 438 being smaller than the distal end 440. Tapering of the shaft 436 in this manner is advantageous in that the center of mass of the apparatus 434 is located nea the distal end 440 of the apparatus 434. Centering of the mass near the distal end 440 is advantageous when the apparatus 434 is grasped and manipulated in an upright position as described in greater detail hereinafter. Use o stainless steel to construct the shaft 436 is desirable because the density of stainless steel accents the "feel" o the apparatus 434 in the surgeon's hand when the mass is centered near the distal end 440. A groove 442 is provided the distal end 440 and is for receiving a finger of the surgeon when the apparatus 434 is grasped. The groove 442 allows for easier grasping and manipulation of the apparatus 434, and also serves as a reference point for the surgeon as described in greater detail hereinafter. Two pins 444, 446 are provided at the distal end 440. The pin 446 is preferably threaded. As shown in Figs. 40 and 41, a plurality of blades 448 are received ove the pins 444, 446. Each of the blades has a sharpened edge 450 for forming incisions. The blades 448 are provide with apertures (not shown) so that they can be received ove the pins 444, 446. The pins 444, 446 stabilize the blades 4 while a nut 452 is provided to secure the blades 448 to the distal end 440 of the shaft 436. A plurality of spacers 454 are provided for holding the blades 448 spaced-apart and parallel to each other. The blades 448 are available from variety of suppliers including Persona Corporation.

The groove 442 is located on a side of the shaft 4 that is opposite the nut 452. As shown in the top view of Fig. 40, the groove 442 is on the right-hand side of the shaft 436 and the nut 452 is on the left-hand side. Such a configuration is designed for right-handed surgeons. A mir image of the apparatus 434 can be provided for a left-handed surgeon.

The surgeon preferably grasps the apparatus 434 wi the right hand and places the index finger on top of the blades 448 just left of the groove 442. The middle finger i received into the groove 442, while the thumb is positioned the left side of the shaft 436. In this way, the apparatus 434 is held upright in a manner similar to holding a pencil or a pen. The groove 442 is preferably shaped in the form of an hourglass. Alternatively, the groove can be half round, i.e. semi-cylindrical, in geometry. As previously described, the groove 442 acts as a reference point so that the surgeon can hold the apparatus 434 the same each time. As the surgeon becomes more familiar with the apparatus 434, the groove 442 makes it easier for the surgeon to determine the location of the blades 448, and particularly the tips of the blades 448, relative to the patient's scalp. Providing the nut 452 on the left-hand side of the shaft 436 is advantageous in that the nut 452 does not interfere with the surgeons grasp when the apparatus 434 is held as just described.

A further advantage of tapering of the shaft 436 as previously described is that it allows the edges 450 of the blade 448 to face a table surface when the apparatus 434 is not in use. Optionally, the distal end 48 can have a flat bottom surface to provide stability when the apparatus 434 is set down and is not in use. This provides safety to the operating personnel by helping to ensure that the blades 448 will not accidently injure a person when the apparatus 434 is not in use.

Referring to Fig. 42, an exemplary method for using the apparatus 434 to produce a hair transplantation donor strip will be described. When forming incisions, the blades 448 of the apparatus 434 are pressed into the scalp 458 so that the blades 448 are aligned parallel to the hairs 456 growing in the scalp 458. The blades 448 are then translated along and through the scalp while the orientation blades 448 relative to the hairs 456 are adjusted so that they remain generally parallel to the hairs 456 at all times. If the blades 448 are maintained generally parallel to the hairs 456, an elongate strip of skin 460 is produced as shown in cross- sectional view in Fig. 43. The hairs 456 in the strip 460 each contain a follicle 462 and can be used for subsequent transplantation.

Referring back to Fig. 42, a portion of hairs 464 extend from the scalp at an angle that is different than the rest of the hairs 456. If the apparatus 434 were translate through the scalp 458 at the location of the hairs 464 and the same orientation shown in Fig. 42, a strip of skin 466 would be produced as shown in cross-sectional view in Fig. Since the blades 448 would not be parallel with the hairs 4 some of the follicles 462 would be severed from the hairs 4 and would not be suitable for subsequent transplantation. This reduces the amount of viable hairs in the strip 66 tha are available for transplantation. The invention provides a method for maintaining t blades 448 in an orientation that is generally aligned with the direction of hair growth in the scalp to produce donor strips as shown in Fig. 43. To produce such a strip, the apparatus 434 is grasped with the hand 468 as illustrated i Fig. 45. The apparatus 434 is held in a manner similar to holding a pen or pencil. In this way, the apparatus 34 is held generally upright, with the proximal end 438 being hel above the hand 468. In contrast, the prior art method as illustrated in Fig. 37 orients the proximal end of the handle 412 beneath the hand 430. As previously described, nut 452 is positioned away from the surgeon's fingers so th the apparatus 434 can more easily be grasped in such a mann The groove 442 serves as a convenient resting place for one the surgeon's fingers. The groove 42 also serves as a reference point for the surgeon.

After the apparatus 434 has been grasped as shown Fig. 35, the blades 448 are positioned above the scalp 470 a a position where the incisions will be initiated. At this point, the surgeon rests the fourth finger, the side of the hand, and/or the wrist against the patient's scalp 470 so t orientation of the blades 448 can be accomplished by movemen of the fingers and thumb and/or by rolling the hand and wris Before making any incisions, the surgeon evaluates the direction of hair growth at the position where the incisions are to be initially started. The surgeon then orients the position of the blades 448 so that they are aligned, i.e., generally parallel, with the hairs at that point. The blades 448 are then pressed into the scalp while maintaining the parallel orientation with the hairs. Once the blades 48 are within the scalp, the surgeon translates the fingers and the thumb toward the wrist to translate the blades 448 along and through the scalp 470. While translating the blades 448 through the scalp 470, the wrist or the side of the hand is maintained against the scalp 470 and is not axially translated. In this way, axial translation of the blades 448 is accomplished solely by movement of the fingers and thumb and not by axial translation of the arm. Translation of the fingers and thumb in this manner is advantageous because the orientation of the blades 448 relative to the scalp 470 can be precisely controlled. As the blades 48 are being translated through the scalp 470, the surgeon continually evaluates the orientation of the hairs growing in the scalp. As the direction of the hairs changes, the surgeon readjusts the orientation of the blades 448 relative to the hairs so that the blades 448 remain parallel to the hairs between the blades at all times during translation. This can be accomplished by movement of the fingers and thumb and/or by rolling the hand while it rests on the scalp 470.

Since the hand 468 remains fixed relative to the scalp 470, the length of the incisions formed by the blades 448 is limited. Usually, an incision having a length of about 2 cm to 3 cm can be made with one stroke of the fingers and thumb while the wrist remains fixed. To increase the length of the incisions, the surgeon ceases translation of the blades 448 and moves the hand 68 further back on the patient's scalp 470 and axially way from the incisions. While maintaining the hand 468 in the new position, the fingers and thumb are again translated to continue translation of the blades 448 along and through the scalp 470. While continuing to pass the blades 48 through the scalp 470, the surgeon continually readjusts the orientation of the blades 448 relative to the direction of hair growth in the scalp 470 so that the hairs between the blades 448 are not destroyed. This process is repeated as many times as necessary until the incisions reach the desired length. For most procedures, the length of the incisions will be in the range from about 5 cm to 20 cm. The apparatus 434 is then removed from the scalp 470 and the skin between the incisions is removed from the scalp 470 in elongate strips. The skin is removed from the scalp by grasping and lift the skin with forceps while separating the skin from the scalp 470 with a scalpel blade scissors. The hair transplantation donor strips can then be cut into smaller skin grafts, usually having about 1 to 6 hairs, which are then transplanted into another area of the scalp 470. By providing a series of precisely controlled movements without axial translation of the hand and arm, the present invention produces hair transplantation donor strips having little or no hairs destroyed. The short, concise strokes are advantageous over the prior art method where a single rapid stroke is made along the length of the scalp an which does not take into consideration the direction of hair growth in the scalp. The invention therefore prevents the destruction of hairs that could otherwise be used in the transplantation procedure. An alternative embodiment of an apparatus 480 for producing donor strips is illustrated in Figs. 46 and 47. T apparatus 480 is essentially identical to the apparatus 434 except that blades 448' are staggered at an angle, θ , with respect to the shaft 436'. Preferably, the blades will be staggered at an angle θ in the range from about 10° to 45°, and more preferably from about 20° to 25°. Such staggering i preferably accomplished angling pins 444' and 446' at the angle θ , as shown.

As illustrated in Fig. 48, hair often grows at an angle which is not orthogonal to the scalp. By providing the apparatus 480 with the staggered blades 448', incisions may made which are tailored according to the angle of hair growth The staggering of the blades 448' allows the blades 448' to b introduced into the scalp at a generally constant angle so that each donor strip is generally uniform in depth and so that fewer hairs are destroyed when producing the donor strip Although the foregoing invention has been described in detail by way of illustration and example, for purposes of clarity of understanding, it will be obvious that certain changes and modifications may be practiced within the scope of the appended claims.

Claims

WHAT IS CLAIMED 18:

1. A method for transplanting hair, comprising: inserting an instrument having a shaft and a line blade that is attached to the shaft normal to the axis of t shaft into the skin to a preselected depth as determined by stop disposed along the shaft to form a linear incision; removing the instrument from the skin; and placing a graft of skin having at least one hair into the linear incision.

2. The method of claim 1, wherein the preselect depth is less than 6 mm, and wherein the instrument is inserted into the skin with the shaft being substantially perpendicular to the skin at the point of incision.

3. A method for transplanting hair, comprising: inserting an instrument having a shaft and a concentric blade that is attached to the shaft normal to th axis of the shaft into the skin to a preselected depth as determined by a stop disposed along the shaft to form a circular incision; removing the instrument from the skin; removing tissue from the circular incision formed the instrument; and placing a graft of skin having at least one hair into the incision.

4. The method of claim 3, wherein the preselect depth is less than 6 mm, wherein the instrument is inserted into the skin with the shaft being substantially perpendicu to the skin at the point of incision, and wherein the preselected depth is variable and is varied by moving the s relative to the blade.

5. A surgical device, comprising: an elongate shaft having a proximal end and a distal end; a blade attached to the distal end of shaft normal to the axis of the shaft; and a stop disposed at a preselected distance from the blade for preventing penetration of the blade beyond the preselected distance.

6. The surgical device of claim 5, wherein the stop is disposed at a distance that is less than about 6 mm from the blade.

7. The surgical device of claim 5, wherein the stop is adjustable relative to the blade to adjust the preselected distance, and wherein the shaft is cylindrical in geometry and has an outer diameter and an inner diameter forming a central lumen, and wherein the blade is concentric in geometry and is flush with the shaft.

8. A method for transplanting a single hair micrograft in a patient's scalp, said method comprising: pressing a spear-shaped blade into the scalp to form an incision having a length that is less than 2 mm, and a width that is less than 0.7 mm; and placing a single hair micrograft in the incision.

9. The method of claim 8, wherein the incision has a length of less than 1.6 mm and further comprising forming at least a second incision within about 0.5 mm to 1.0 mm from the first incision and placing a single hair micrograft in the second incision.

10. A surgical instrument for forming a single ha micrograft incision in the skin, comprising: an elongate shaft having a proximal end and a dist end; and a spear-shaped blade on the distal end of the shaf and wherein the blade has a length that is less than 1.8 mm.

11. A surgical handle assembly, comprising: an elongate cylindrical sheath having a proximal end, a distal end, and a central lumen therebetween; a chuck member slidable within the sheath lumen, t chuck member having a proximal end and a distal end, wherein the proximal end is threaded, and wherein a set of at least two prongs are disposed at the distal end; and a threaded end element for mating with the proxima threaded end of the chuck member, wherein rotation of the en element relative to the chuck member proximally translates t chuck member within the lumen to translate the prongs toward each other as the prongs engage the distal end of the cylindrical shaft.

12. The device of claim 11, further comprising an elongate shaft having a proximal end and a distal end, where a spear-shaped blade is on the distal end of the shaft, wherein the blade has a length that is less than 1.8 mm, and wherein the proximal end of the shaft is received in the prongs of the chuck member.

13. The device of claim 11, further comprising elongate cylindrical shaft having a proximal end, a distal end, and an axial lumen, the shaft having blade on its dista end, wherein the blade has a diameter that is less than 2 mm and wherein the proximal end of the shaft is received in the prongs of the chuck member.

14. A method for forming a dermal punch comprising: providing a hypodermic needle having a concentric cylindrical shaft and a sharpened angled distal portion at a distal end of the shaft; removing the angled distal portion from the shaft to produce a rim at the distal end which is normal to the axis of the shaft; and sharpening the rim to provide a concentric blade on the distal end of the shaft.

15. The method of claim 14, wherein the cylindrical shaft includes an inner wall and an outer wall, and wherein the sharpening step comprises reaming the inner wall or outer wall adjacent the distal end.

16. The method of claim 14, further comprising mounting a luer lock on a proximal end of the shaft and placing a handle having a male fitting into the luer lock, and further comprising attaching a suction source to the handle, the suction source providing suction though the handle and the concentric shaft.

17. A method for transplanting hair, comprising: inserting an instrument having a concentric cylindrical shaft and a blade on a distal end of the shaft normal to the axis of the shaft into the skin to a preselected depth to form a cylindrical incision, wherein the thickness of the wall of the shaft is in the range from about 0.2 mm to 0.5 mm; removing the instrument from the skin; and placing a graft of skin having at least one hair into the cylindrical incision.

18. A dermal punch, comprising: an elongate concentric cylindrical shaft having a proximal end and a distal end; a blade on the distal end of shaft normal to the axis of the shaft; and a luer lock attached to the proximal end of the shaft.

19. The dermal punch of claim 18, wherein the sha is constructed of stainless steel, and wherein the proximal end of the shaft is an open, and wherein the wall of the sha has a thickness in the range from about 0.2 mm to 0.5 mm, an further comprising a handle having a male fitting disposed i the luer lock, and further comprising means for providing suction through the concentric shaft.

20. A method for transplanting hair, comprising: providing an instrument having a concentric cylindrical shaft having a proximal end, a distal end, and a axis extending therebetween, wherein a blade is on a distal end of the shaft normal to the axis of the shaft, and wherei an escape port is the wall of the shaft near the distal end; inserting the instrument into the skin to a preselected depth where the skin is below the escape port to form a cylindrical incision; removing the instrument from the skin; repeating the step of inserting the instrument int the skin while allowing accumulated skin in the shaft to be forced through the escape port; and placing a graft of skin having at least one hair into at least one of the cylindrical incisions.

21. A dermal punch, comprising: an elongate concentric cylindrical shaft having a proximal end and a distal end; a blade on the distal end of shaft normal to the axis of the shaft; and wherein the shaft defines an aperture near the distal end having a periphery sufficiently large to allow accumulated tissue in the shaft to escape through the aperture when the distal end of the shaft is pressed into the scalp.

22. The punch of claim 21, wherein the shaft is constructed of carbon steel, wherein the aperture is positioned about 5 mm or greater from the distal end, wherein the aperture is elliptical in geometry, wherein a first axis of the ellipse has a length equal to about ninety percent of the inner diameter of the shaft, and wherein a second axis of the ellipse has a length about five times the length of the first axis or greater.

23. The punch of claim 21, further comprising an inwardly extending protrusion on the shaft for engaging tissue directed into the shaft.

24. A method for forming a dermal punch, comprising: providing a length of steel tubing; grinding or reaming one end of the tubing to produce a blade on the tubing; forming a hole in a wall of the tubing near the blade; and inserting the tubing into a lumen of a handle.

25. A method for transplanting hair from one area of the scalp to another, the method comprising: providing a surgical instrument having at least two planar blades, with each blade having a sharpened edge, and wherein the blades are substantially parallel to each other; translating the blades along and through an area o the scalp having hair to form at least two parallel incision in the scalp; adjusting the orientation of the blades relative t the hair such the blades are generally aligned at all times with the direction of hair growth for the hair between the blades when making the incisions; removing a graft of skin having hair from between the incisions formed by the blades; and placing at least a portion of the graft of skin having at least one hair into another area of the scalp.

26. The method of claim 25, further comprising grasping the instrument between the thumb and at least one finger and maintaining the wrist in a fixed position relative to the scalp while translating the finger towards the wrist t translate the blades along and through the scalp, and further comprising ceasing translation of the blades; repositioning the wrist relative to the scalp; and repeating the step of translating the finger toward the wrist to increase the lengt of the incisions formed by the blades.

27. A surgical apparatus for forming parallel incisions in the skin, comprising: an elongate shaft having a proximal end and a dista end; a plurality of parallel spaced-apart planar blades at the distal end of the shaft; and wherein the shaft is tapered from the distal end to the proximal end such that the center of mass of the apparatu is near the distal end of the shaft.

28. The apparatus of claim 27, wherein the distal end defines a groove for receiving a finger when the shaft is grasped by a surgeon, and wherein the groove is aligned in a plane that is parallel with the plane of the blades.

29. An improved surgical apparatus for forming parallel incisions in the skin of the type including an elongate shaft having a proximal end and a distal end, and a plurality of parallel spaced-apart blades held at the distal end of the shaft, wherein the blades are held at the distal end by a threaded pin and a nut on a left hand side of the apparatus, wherein the improvement comprises tapering the shaft from the distal end to the proximal end such that the center of mass of the apparatus is near the distal end of the apparatus and forming a groove in the shaft opposite the side of the shaft having the nut.

30. The improved apparatus of claim 29, wherein the blades are staggered at an angle in the range from 10 degrees to 45 degrees relative to the shaft.