CN117580556A - Apparatus and method for removing tissue - Google Patents

Abstract

Devices and methods for selectively dissecting epithelial tissue layers are disclosed. The device comprises: an elongated head and a flexible handle. The flexible handle includes at least one component configured to bend the flexible handle upon application of external pressure and return the flexible handle to its original position upon release of the external pressure.

Description

Apparatus and method for removing tissue

Cross Reference to Related Applications

The present application claims priority benefits from U.S. provisional patent application No. 63/181,532 filed on 29 a month 2021 and U.S. provisional patent application No. 63/296,194 filed on 4 a month 2022, both entitled "apparatus and method for removing tissue," the contents of both of which are incorporated herein by reference in their entirety.

Technical Field

The present invention relates to the field of tissue removal, and more particularly, to an apparatus and method for tissue removal.

Background

Removal of thin tissue layers is often performed during various medical procedures and operations, such as ophthalmic procedures, vaginal procedures, oral procedures, cosmetic procedures (e.g., facial peeling, etc.), and the like. In medical procedures, a doctor carefully moves the blade over the surface of body tissue during the removal action. The success or failure of such procedures depends in large part on whether the physician can control the amount of pressure applied to the blade and the angle at which the blade meets the tissue. Too much pressure or misalignment of the angle can damage the tissue or result in insufficient tissue ablation.

In cosmetic procedures, peeling off the epithelial layer (also known as skin resurfacing, micro-grinding, laser resurfacing, debridement, etc.) can rejuvenate and rejuvenate the skin. To peel off the epithelium, professionals or users scrape the face with abrasive paste, apply an acidic paste to the face, or use cosmetic lasers to cause superficial burns. All of the listed techniques may cause damage to the deep layers of the skin because these methods have limited control over the depth of exfoliation. The success or failure of cosmetic peeling procedures depends to a large extent on the level of expertise of the user performing the procedure and its ability to evaluate the sensitivity of the skin being treated.

Thus, there is a need for a device that performs accurate and controlled tissue removal for any purpose. Such devices may include blades that enable thin tissue layer removal while being less sensitive to the skill level of the user operating the device.

Disclosure of Invention

The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope.

Some aspects of the invention relate to an apparatus comprising: an elongated head and a flexible handle, wherein the flexible handle comprises at least one component configured to bend the flexible handle upon application of external pressure and return the flexible handle to its original position upon release of the external pressure.

In some embodiments, at least one component is selected from: at least a portion of a flexible handle made of an elastomeric material, a spring, and a connector. In some embodiments, the flexible handle is a replaceable handle. In some embodiments, the flexible handle includes a connector for detachably connecting the flexible handle to the elongated head.

In some embodiments, the head is provided with one or more recesses configured to engage with the flexible handle, and wherein the recesses are provided at a proximal end of the head, the engaging with the flexible handle comprising not contacting a distal edge of a blade included in the elongated head.

In some embodiments, the elongate head comprises one or more blades positioned substantially parallel to the at least one guide clip strip, and wherein the length of the elongate head ranges between 1-100 millimeters, and the distal end of the elongate head has a length formed by the elongate edges of the one or more blades ranging between 1-50 millimeters. In some embodiments, at least one of the elongated edges is covered with a functional coating selected from the group consisting of: lubricating materials, pharmaceuticals, nutritional materials, moisturizing materials, and preservative materials. In some embodiments, the device further comprises another guide clip strip, wherein the blade is a double sided blade, and wherein two guide clip strips are disposed on either side of the one or more blades.

Still other aspects of the invention relate to methods of remodelling tissue comprising: applying external pressure to a flexible handle connected to the elongate head, wherein the flexible handle comprises at least one component configured to flex the flexible handle upon application of the external pressure and return the flexible handle to its original position upon release of the external pressure.

In some embodiments, the external pressure is applied while moving the elongate head over the tissue. In some embodiments, the at least one component is selected from at least a portion of a flexible handle made of an elastic material, a spring, and a joint.

In some embodiments, the exfoliated portion of tissue is a corneal epithelium that does not include bowman's layer. In some embodiments, the dissected portion of tissue is a portion of one of vaginal tissue, oral and nasal tissue.

In some embodiments, the method further comprises collecting any exfoliated tissue and released residue in the head hopper. In some embodiments, the released residue is a liquid. In some embodiments, collecting comprises absorbing with an absorbent material at least partially coated on the funnel.

In some embodiments, the method further comprises orienting the elongate head with respect to the tissue to define a penetration depth of the elongate edge of the one or more blades into the tissue.

In some embodiments, the elongate head comprises one or more blades positioned substantially parallel to the one or more guide clips, and wherein the length of the elongate head is between 1-100 millimeters and the distal end of the elongate head has a length in the range of 1-50 millimeters formed by the elongate edges of the one or more blades. In some embodiments, the method further comprises orienting the one or more guide clips and the one or more blades substantially parallel to a tangent to the tissue such that the one or more blades penetrate to a relatively shallow depth and remove a thin layer of tissue. In some embodiments, the method further comprises orienting the elongated one or more guide clips and the one or more blades substantially perpendicular to a tangent to the tissue such that the elongated blade penetrates to a depth corresponding to a difference in height between the one or more guide clips and the one or more blades and removes a layer of tissue corresponding to the penetration depth.

In some embodiments, applying external pressure includes pressing an elongated edge of one or more guide clips onto the tissue to flatten a surface of the tissue and enclose a portion of the flattened tissue within the gap to peel the tissue at a uniform thickness.

In some embodiments, the method further comprises performing any one of the following after the peeling step: ophthalmic refractive surgery, treatment of myopia disorders, treatment of hyperopia disorders, treatment of astigmatism disorders, and treatment of keratoconus disorders.

Some other aspects of the invention relate to an apparatus comprising: an elongated head and a curved handle bent at a predetermined angle between a central axis of a portion of the handle configured to be gripped by a user and a connection surface of a connector connecting the elongated head, wherein the predetermined angle is 90 to 150 degrees with respect to the head and the blade.

In some embodiments, the handle is a replaceable handle. In some embodiments, the connector is configured to detachably connect the flexible handle to the elongate head.

Some additional aspects of the invention relate to methods for remodelling tissue, comprising: an external pressure is applied to a curved handle connected to the elongated head, wherein the curved handle is curved at a predetermined angle between a central axis of a portion of the handle configured to be gripped by a user and a connection surface of a connector connecting the elongated head, and wherein the predetermined angle is 90-150 degrees with respect to the head and the blade.

Some other aspects of the invention relate to a method for selectively dissecting an epithelial tissue layer, the method comprising: providing an apparatus, the apparatus comprising: an elongated head and a handle, wherein the elongated head comprises one or more blades positioned substantially parallel to the one or more guide clips, and wherein the length of the elongated head ranges between 1-100 millimeters, and the distal end of the elongated head has a length formed by the elongated edges of the one or more blades ranging between 1-50 millimeters; and removing the epithelial tissue layer by moving one or more blades over the designated tissue using the handle.

In some embodiments, the epithelial tissue is a portion of facial skin. In some embodiments, removing the skin layer further comprises at least one of: removing senile plaque, removing shallow lesions, and removing postoperative scar.

In some embodiments, removing the skin layer further comprises at least one of: the collection removal layer was used for pathology sampling and the collection removal layer was used for smear squamous cell sampling. In some embodiments, collecting includes accumulating the layer in a cavity between the one or more guide clips and the one or more blades. In some embodiments, at least one of the elongated edges is covered with a functional coating selected from the group consisting of a lubricating material, a pharmaceutical, a nutritional material, a moisturizing material, and a preservative material.

In some embodiments, the device further comprises one or more guide clips, wherein the one or more blades are single-sided or double-sided blades, and wherein the one or more guide clips are disposed on either side of the double-sided blades. In some embodiments, the device is a disposable device, and wherein the one or more blades are made of a polymeric material having a shore hardness of between 20 and 90 SHD.

Some other aspects of the invention relate to an apparatus comprising: an elongated head and a handle, wherein the elongated head comprises one or more blades positioned substantially parallel to the one or more guide clips, and wherein the length of the elongated head ranges between 1-100 millimeters, and the distal end of the elongated head has a length ranging between 1-50 millimeters formed by the elongated edges of the one or more blades, and wherein the one or more blades are made of a polymeric material having a shore hardness between 20 and 90 SHD.

In some embodiments, the handle is a flexible handle. In some embodiments, the device further comprises two or more guide clips, wherein the one or more blades are double-sided blades, and wherein the two guide clips are disposed on either side of the double-sided scraping blade.

In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed description.

Drawings

Exemplary embodiments are shown with reference to the accompanying drawings. The dimensions of the components and features shown in the figures are generally chosen for convenient and clear illustration, and so the dimensions are not necessarily shown to scale. These figures are listed below.

FIGS. 1A-1C illustrate an apparatus for removing a surface layer of tissue according to an embodiment;

FIGS. 2A-2I illustrate various views of the device of FIGS. 1A-C, wherein FIGS. 2A-D and 2F-I illustrate cross-sections corresponding to those shown in FIG. 2E, in accordance with an embodiment;

3A-3D collectively illustrate the device of FIGS. 1A-C coupled with a handle according to an embodiment;

FIG. 3E is an illustration of a handle according to some embodiments of the invention;

FIG. 3F is an enlarged illustration of a connector for connecting a handle to an elongated head according to some embodiments of the invention;

FIGS. 4A-4C illustrate three additional cross-sectional views of the device of FIGS. 1A-C in accordance with embodiments of the present invention;

FIG. 5 illustrates a three-bladed device for removing a tissue surface layer according to an embodiment of the present invention; and

FIG. 6 is a flow chart of a method of selectively peeling an epithelial layer according to some embodiments of the invention.

Detailed Description

Disclosed herein are devices for removing a surface layer of tissue, such as corneal epithelium ("epithelial tissue"), vaginal tissue, oral tissue, nasal tissue, and the like, and methods of operating the devices. In some embodiments, the device may include a flexible handle configured to provide safe operation to the device. The flexible handle may reduce the sensitivity of the removal operation to the pressure and angle exerted by the physician performing the operation on the blade that removes the surface layer of tissue.

In some embodiments, the device may further comprise a head formed by at least one blade disposed substantially parallel to the guide clip strip. Such heads are provided for controllably peeling or scraping tissue. The blade forms the distal end of the device and is configured to strip tissue, while the guide clip strips limit penetration of the blade to control the thickness of the stripped tissue, thereby preventing damage to deeper tissue layers. The two blades enclose a funnel that collects the removed tissue or fluid. The head may be coupled to a flexible handle, enabling a user or an automated robot to manipulate the blade on the tissue.

Referring now to fig. 1A, 1B and 1C, an apparatus for removing a surface layer of tissue (e.g., corneal epithelium) is shown in accordance with an embodiment. An elongated head 100 is shown having sides that are substantially trapezoidal with the longer distal end forming the top of the trapezoid being parallel to the shorter proximal end forming the bottom of the trapezoid. For ease of description of the head 100, three orthogonal axes are labeled in fig. 1C. An axis labeled "vertical axis" extends from the proximal end to the distal end of the head 100. An axis labeled "longitudinal axis" extends from the front end to the rear end of the head 100. The axis labeled "lateral axis" represents the depth or thickness of the head 100 and is perpendicular to the vertical and longitudinal axes.

The front side of the head 100 tapers from a longer distal end to a shorter proximal end forming a rounded acute angle at the front distal corner of the trapezoid and an obtuse angle at the front proximal corner of the trapezoid. The acute angle may range from 25 ° to 75 °. In one embodiment, the acute angle is 40 °, 45 °, or 50 °. The rounded corners at the front distal corners of the trapezoids may bulge outwardly such that the front end is lower than the distal end of the trapezoids, forming a rounded protruding tip at the front face of the head 100. In some embodiments, the rounded protruding tip protrudes along the longitudinal axis to a distance of 0.2 millimeters (mm), or 0.15-2.5mm, or 0.1-0.3mm from the front edge of the distal face of the head 100. In some embodiments, the distance along the longitudinal axis between the forward end of the rounded protruding tip and the distal end of the head 100 is 0.2mm, or 0.15-2.5mm, or 0.1-0.3mm. The rear side of the head 100 is substantially perpendicular to the distal end of the head 100, forming a rear wall that is substantially orthogonal to the parallel top and bottom of the trapezoid. The rear distal corners of the trapezoids may be rounded along a plane defined by the longitudinal vertical axis, forming a convex surface on the rear face of the head 100.

In some embodiments, the head 100 has a width or thickness in the range of 1-100 millimeters (mm), such as 2-5mm, or 2.5-4.5mm, or 2.7-4mm, or 2.8-3.5mm, about 3mm. In some embodiments, the height of the head 100 from the proximal end to the distal end is between 1-50mm, such as 4-10mm, or 5-8mm, or 6-7mm, or 6.2-6.7mm.

In some embodiments, the elongate head 100 includes one or more blades 104 disposed substantially parallel to the one or more guide clips 102, and wherein the elongate head 100 has a length ranging between 1-100 millimeters and the distal end of the elongate head has a length ranging between 1-50 millimeters formed by the elongate edges of the one or more blades 104.

The distal end of the elongate head 100 is formed by a guide clip strip 102 positioned substantially parallel to at least one elongate blade 104 along a longitudinal axis. In some embodiments, blade 104 is made of a polymeric material having a shore hardness between 20 and 90SHD (shore D).

In some embodiments, blade 104 is made of a polymeric material having a shore hardness between 30 and 80 SHD. In some embodiments, blade 104 is made of a polymeric material having a shore hardness between 20 and 80 SHD. In some embodiments, blade 104 is made of a polymeric material having a shore hardness between 40 and 90 SHD. In some embodiments, blade 104 is made of a polymeric material having a shore hardness between 40 and 80 SHD. In some embodiments, blade 104 is made of a polymeric material having a shore hardness between 50 and 90 SHD.

In one embodiment, the angle between the control member and the blade along the longitudinal axis may range between 5-75 °, or alternatively between 15-30 °. Clip strip 102 and blade 104 each include an elongated wedge portion that spans from the front side to the rear side of head 100 and has a substantially triangular cross-section with a narrow, distally disposed edge corresponding to the "tip" of the triangle and a wide, thin, proximally disposed base corresponding to the "base" of the triangle. The outer walls of each of elongate guide clip strip 102 and blade 104 along the longitudinal axis are convex, forming the arcuate sides of the triangle. The front distal corners of control and clip strip 102 and blade 104 may taper to form rounded front distal corners of the trapezoidal face of head 100. Similarly, the rear distal corners of control and clip strip 102 and blade 104 may taper to form rounded rear distal corners of the trapezoidal face of head 100.

The elongated edge of blade 104 extends distally beyond the elongated edge of guide clip strip 102 and is a sharp edge configured to cut, strip or shave epithelial tissue, thereby forming a distal tip of head 100. In some embodiments, the outer edge of blade 104 forms an acute angle of about 5 ° -75 °, such as 10 ° -50 °, or 15 ° -45 °, or 20 ° -40 °, or 25 ° -35 °, or about 30 °. The elongated edge of blade 104 may extend over a rounded front distal corner of head 100, providing a convex surface comprising the distal and front ends of head 100.

In some embodiments, at least one of the elongate edges of clip strip 102 and blade 104 may be covered with a functional coating that may be selected from the group consisting of a lubricating material, a pharmaceutical, and a corrosion resistant material.

The elongated edge of guide clip strip 102 is disposed below the elongated edge of blade 104 and is configured to press against tissue without the blade, thereby forming a barrier that limits the depth of penetration of the sharp edge of blade 104. The outer edges of the guide clip strips 102 may form rounded corners having a radius ranging from 0.05mm to 0.1mm, or one or more flat bands. The elongated edge of guide clip strip 102 may extend over the rounded front distal corner of head 100 to provide a continuous barrier to the elongated edge of blade 104. In one non-limiting embodiment, the elongated edge of guide clip strip 102 is disposed 0.01-1mm, such as 0.05-0.1mm, or 0.1-0.15mm, or 0.15-0.2mm, or 0.2-0.25mm, or 0.25-0.3mm, or 0.3-0.5mm, or 0.05-0.5mm, below the elongated edge of blade 104. The elongate distal edges of clip strip 102 and blade 104 are separated by a substantially uniform gap aligned with the transverse axis (e.g., which may vary between + -15% along its length) that extends from the front end to the rear end of head 100 and to the front distal rounded corner of head 100, thereby forming a distal front opening of elongate funnel 106 that extends from the front end to the rear end of head 100. The width of the gap may range from 0.01 to 1mm, for example from 0.1 to 1.0mm, or from 0.8 to 0.2mm, or from 0.7 to 0.3mm, or from 0.6 to 0.3mm, or from 0.5 to 0.3mm. In some embodiments, the width of the gap is 0.4mm.

The distal edge 102a of the guide clip strip 102 may include a blunt strip or band extending along the distal surface of the guide clip strip 102. The possible width of the cuff ranges from 0.01-1mm, for example 0.05 to 0.25mm. The band may be warped having a non-uniform height differential relative to the sharp edge of blade 104 and resulting in a non-uniform height differential between elongate clip strip 104 and blade 102. In one non-limiting embodiment, distal edge 102a is raised higher in a middle portion of the elongated edge leading to clip strip 102, resulting in a smaller difference in height between clip strip 102 and a middle portion of blade 104, and a larger difference in height between clip strip 102 and a peripheral portion of blade 104. In some embodiments, the difference in height between the distal edge of guide clip strip 102a and the distal edge of blade 104 at the ridge is 10% or 20% or 30% or 40% or 50% less than the difference in height at the peripheral portions of guide clip strip 102 and blade 104. The cuff may be parallel to the proximal base of the head 100 or may be gently sloped along the outer convex surface of the guide clip strip 102. In some embodiments, the range of tilt is 5 ° -75 °, such as 10 ° -15 °, or 15 ° -20 °, or 20 ° -25 °, or 25 ° -30 °, or 30 ° -35 °.

The penetration depth of the blade 104 may be determined by a combination of: the angular orientation of head 100 relative to the corneal surface, the width of the gap between clip strip 102 and blade 104, and their respective height differences. Thus, the penetration depth of blade 104 may be controlled by adjusting the controls and the angle of clip strip 102 and blade 104 relative to the cornea, wherein orienting clip strip 102 and blade 104 substantially parallel to a tangent to the cornea causes blade 104 to penetrate to a relatively shallow depth, thereby allowing removal of thin layers of epithelial tissue, and orienting clip strip 102 and blade 104 perpendicular to the tangent to the cornea causes blade 104 to penetrate to the height differential between clip strip 102 and blade 104, thereby removing thicker layers of epithelial tissue corresponding to the penetration depth. Similarly, a non-uniform height differential between guide clip strip 102 and blade 104 may be utilized to peel a wider or narrower layer from the cornea (or any other tissue), with a smaller differential between the central portion of blade 104 and guide clip strip 102 resulting in a thinner peel slice and a larger differential between the peripheral portion of blade 104 and guide clip strip 102 resulting in a thicker peel slice.

In some embodiments, the distal end of the head 100 forms the top of a trapezoid, and the length of the distal end may range from 1-50mm, such as 4-10mm, or 5-9mm, 6-8mm, or about 7mm. In some embodiments, the length of the head 100 ranges between 1-100mm, e.g., 5-13mm, or 6-12mm, or 7-11mm, or about 10mm, with an outwardly protruding rounded front tip. In some embodiments, the rear side of the head 100 forms an orthogonal side of a trapezoid, which may have a height along the longitudinal axis in the range of 2-8mm, or 4-6 mm. In some embodiments, guide clip strip 102 prevents blade 104 from penetrating beyond the corneal epithelium by a thickness in the range of between 50-70 micrometers (μm). In some embodiments, the axis of the height differential between guide clip strip 102 and blade 104 is substantially perpendicular to the axis of the gap between the blades, with the respective beveled edges being angled 20 ° or 25 ° or 30 ° or 35 ° or 40 ° or 45 ° or 50 ° or 55 ° or 60 ° or 65 ° relative to the axis of the gap or the axis of the height differential.

Additionally or alternatively, guide clip strip 104 may be manipulated to press against tissue to flatten the surface of the tissue to a degree that allows blade 102 to strip the epithelial tissue at a uniform thickness. The gap between clip strip 102 and blade 104 may enclose a portion of flattened tissue and may be small enough to prevent the pliable tissue enclosed therein from bouncing back to its natural shape.

The opposing facing inner walls of the elongated wedge-shaped portions of clip strip 102 and blade 104 enclose a funnel 106 for collecting any exfoliated epithelial tissue and/or other released or secreted residue. Funnel 106 may be gunny-shaped in cross-section with a narrow elongate distal opening spanning from the front end to the rear end of head 100 and being formed by the elongate distal edges of clip strip 102 and blade 104, corresponding to the gap between the clip strip and blade, while a wider elongate proximal base is formed by the concave inner walls of the wedge-shaped portions of clip strip 102 and blade 104. The gunny bag shape allows severed tissue and/or released fluid to flow proximally from the corneal surface. Funnel 106 may have one or more parallel elongated grooves 108 embedded in the interior wall of the funnel and extending substantially parallel to the edges of clip strip 102 and blade 104 throughout the length of head 100. Grooves 108 may be provided at different heights on the inner wall of funnel 106 and may increase the surface area of the wall of funnel 106 to enhance the capillary action of funnel 106. In one embodiment, the funnel 106 has one, two, three or more grooves 108.

In some embodiments, the base of the funnel 106 is 300%, or 400%, or 500%, or 600%, or 700%, or 800%, or 900%, or 1000% wider than the gap forming the distal opening of the funnel 106. In some embodiments, the depth or height of funnel 106 from the distal opening to the base is 0.1-0.8mm, or 0.2-0.7mm, or 0.3-0.6mm, or 0.4-0.5mm.

Funnel 106 may be at least partially coated with an absorbent substance, such as a sponge-like material, suitable for absorbing fluids, such as tears, water, pharmaceutical fluids that may be released from tissue during cutting, peeling, removal or reconstruction, and/or any peeled tissue. The absorbent material may increase the rate of fluid evacuation from the tissue surface during the procedure, thereby relatively drying the tissue surface, which may reduce the chance of uncontrolled sliding of blade 104 on the tissue during the cutting/stripping procedure. In one embodiment, the absorbent material is disposed within the recess 108 as an elongated absorption funnel. Additionally or alternatively, the elongate base of the funnel 106 may be fully or partially coated with an absorbent material to provide an absorbent pocket for any cut tissue and/or released fluid.

Fig. 1A shows a substantially flat rear end of head 100. The rear opening of funnel 106 has a gunny-like shape as described above, with a narrow distal opening defined by the distal edges of clip strip 102 and blade 104 and a wider base defined by the inwardly projecting walls of the proximal wedge-shaped portions of clip strip 102 and blade 104. The rear end of the head 100 may be provided with a window 110 positioned proximally relative to the funnel 106. The window 110 may be square or rectangular in shape with straight sides and rounded corners.

Referring to fig. 1B, a tapered front end 112 of head 100 is shown, formed by an outwardly convex front wall and rounded front distal corners of clip strip 102 and blade 104. A portion of the front distal rounded corner of blade 104 may be hollowed out to form a narrow recess that includes the front opening of funnel 106. The narrow front opening of the funnel 106 may prevent any exfoliated epithelial tissue collected therein from falling off the front end of the head 100, allowing the user to manipulate the head 100 accordingly while performing a procedure. Similarly, the rounded tapered front distal corner of head 100 may allow a user to maneuver head 100 over tissue during a procedure to accurately position controls and clip strip 102 and blade 104 over the surface of the tissue.

Referring now to fig. 1C, there is shown a non-limiting example of the bottom proximal side of head 100 having recess 114 configured to engage a flexible handle and described in more detail below. Recess 114 may have any suitable shape that engages the flexible handle. In one embodiment, recess 114 forms a cross on the proximal face of head 100, with the longer rectangular portion of the cross being longitudinally disposed along the length and surrounded by the proximal face of head 100, and the shorter rectangular portion of the cross being laterally disposed and dividing the proximal face of head 100 into two portions, thereby forming two gaps 114a. The gap 114a may extend to the sides of the head 100 to form two hollowed-out lips 114b on each trapezoidal face of the head 100. Gap 114a with lip 114b may penetrate head 100 along a lateral axis, thereby forming a hollowed-out window. The head 100 may also be equipped with additional recesses, such as recesses 116 disposed on either side of the head 100 at the proximal rear corners of the head 100 and recesses 118 disposed on either side of the head 100 at the proximal front corners of the head 100. The recess 116 may be parallelogram shaped and may be positioned on a flat surface of the head 100, while the recess 118 may be trapezoidal shaped and may be positioned on a contoured tapered front surface of the head 100 that surrounds the outer surface of the head 100 toward the tapered front edge of the head. Recesses 116 and/or 118 may extend through head 100 along a lateral axis, thereby forming one or more hollowed-out windows.

Clip strip 102 and blade 104 may comprise biocompatible polymers or metals and may be coated with a hydrophilic material to enhance the collection of any released fluid within chamber 106. Metal blades may be manufactured with a high surface finish to reduce inflammation and/or sculpting effects on tissue.

The header 100 may be configured for a limited number of procedures, such as one, two, or more procedures, and then discarded. Alternatively, the head 100 may be adapted for sterilization and may be used any number of times.

In one embodiment, the head 100 has three or more distally disposed blades: two guide clips 102 are positioned on either side of one or more center blades 104. The blade is substantially similar to the blades described above, with the obvious difference that one or more of the blades 104 are double sided blades, allowing for controlled bi-directional peeling/removal of the epithelium. The guide clip strip 102 may be symmetrically disposed about the central one or more blades 104, having the same features as described above. Alternatively, the guide clip strip 102 may have different gaps and different height differences relative to the center blade 104, thereby achieving greater variability in controlling the thickness of the stripped tissue.

Optionally, the contact surface area of the multi-bladed head is smaller than the contact surface area of the dual-bladed head. The number of blades and their respective positions relative to each other may be selected to achieve a desired contact surface area with the cornea.

Referring now to fig. 2A-2I, there are shown a plurality of cross-sectional views of the head 100 corresponding to the slices shown in fig. 2E. Fig. 2A-D show a narrow front opening of the funnel 106, while fig. 2F-2I show a wider gunny-like rear opening of the funnel 106. The difference in height and the gap between guide clip strip 102 and blade 104 are clearly shown. Fig. 2F-I show grooves 108 disposed at different heights along the inner wall of funnel 106.

Fig. 2B-2D illustrate various cross-sectional views of recess 114. Specifically, fig. 2D shows engagement with a handle coupled to the head 100.

Referring now to fig. 3A-3D, collectively, there is shown an elongated head 100 coupled with a handle 200, which may be a flexible handle, disposable handle, and/or replaceable handle that allows a user to manipulate the head 100 over tissue, according to an embodiment. Alternatively, as shown in fig. 3D, the handle 200 may be a curved handle having two portions 200A and 200B.

In some embodiments, the length of the elongate head 100 ranges between 1-100 millimeters, and the distal end of the head has a length ranging between 1-50 millimeters formed by the elongate edge of the blade 104 positioned substantially parallel to the elongate edge of the guide clip strip 102. In some embodiments, blade 104 is made of a polymeric material having a shore hardness between 30 and 80 SHD.

Fig. 3A shows the handle 200 disengaged from the head 100, the handle 200 may be a disposable handle and/or a replaceable handle. Fig. 3B shows the handle 200 engaged with the head 100, while fig. 3C shows a close-up 204 of the handle 200 engaged with the head 100. The handle 200 may include at least one component (not shown) configured to bend the flexible handle 200 when external pressure is applied and to return the flexible handle to its original position when external pressure is released. In some embodiments, the at least one component may be selected from: at least a portion of a flexible handle made of an elastomeric material, a spring, and a connector. For example, the flexible handle 200 may be made of an elastomer or any other polymer that can flex the flexible handle 200 when external pressure is applied and return the flexible handle 200 to an original position when external pressure is released. In another example, the mechanism includes a joint connecting two portions of the flexible handle 200 that can pivotally move the two portions relative to one another when external pressure is applied to the flexible handle 200. The mechanism may further comprise a return spring for returning the two parts to their original positions when the external pressure is released.

The handle 200 may taper toward its distal end and may be provided with a clip-like connector 202 comprising, for example, two flat disc-like tips having a width that is greater than the tapered portion of the handle 200. In some embodiments, the connector 202 may detachably connect the handle 200 to the head 100. The tip 202 may be used to couple the handle 200 with the head 100 by inserting the tip 202 with a longitudinally oriented flat side into a longer rectangular portion of a cross shape, such as the recess 114, with the head 100. The handle 200 may be rotated 90 ° so that the flat side with the tip 202 is oriented to align with the cross-shaped shorter rectangular portion of the recess 114. The tip 202 may be split and coupled to the head 100 by locking into either end of the longer rectangular portion. Alternatively, the head 100 and the flexible/curved handle 200 are integrally formed. Alternatively, the recesses 116 and 118 may be used to engage the flexible/curved handle 200 with the head 100 and/or release the flexible/curved handle 200 from the head.

Alternatively, the head 100 may be engaged with the handle 200 using any other suitable connector 202 (e.g., by a threaded connection, a mounting element, a joint, and/or any other type of coupling). The coupling between the head 100 and the handle 200 may fix the orientation of the head 100 relative to the handle 200 such that movement of the head 100 is actuated only by a user manipulating the handle 200. In some embodiments, the head 100 may be at least partially rotatable about the handle 200.

Alternatively, the handle 200 may be reusable or disposable and suitable for sterilization.

Reference is now made to fig. 3E, which is an illustration of the handle 200 of the device of fig. 3D, according to some embodiments of the invention. The handle 200 may include two portions 200A and 200B and a connector 202. In some embodiments, the handle 200 may be a flexible handle made of a flexible material. In some embodiments, flexibility may be achieved by forming a return bend between portions 200A and 200B and/or between portion 200B and connector 202. For example, a spring-like element may connect portion 200A to 200B and/or portion 200B to connector 202.

In some embodiments, the handle 200 may be a curved handle having a fixed predetermined angle between the portion 200B and the connector 202. An enlarged view of the connector 202 connected to the portion 200B at a fixed angle is shown in fig. 3F. In some embodiments, the angle α is defined as the angle between the central axis x of the handle 200 and the connecting surface 'S' of the connector 202. In some embodiments, the angle α is between 90 ° and 150 °. In some embodiments, the angle α is between 100 ° and 150 °, between 110 ° and 150 °, between 115 ° and 150 °, and between 120 ° and 150 °.

Referring now to fig. 4A-4C, which illustrate three cross-sectional views of head 100, and detailed views of recesses 114, 116 and 118, 118a, 118b and 118C, recesses 114, 116 and 118a, 118b and 118C are configured to engage and/or release flexible/curved handle 200 from head 100. The recess 118 may include one or more ratchet-like features that may alternately lock and unlock the flexible/curved handle 200 with the head 100.

The following is a method of modifying tissue according to an embodiment.

Alternatively, the method may be used to remodel corneal epithelium. Alternatively, the method may be performed prior to an ophthalmic refractive procedure for treating myopia, hyperopia, astigmatism, keratoconus, or other disorders. For example, refractive surgery may include procedures for reshaping corneal curvature, for example using surface ablation methods such as photorefractive keratectomy (PRK), phototherapy keratectomy (PTK), laser assisted epithelial keratomileusis (LASEK), EPI-LASEK, advanced surface grinding (ASA) techniques.

Alternatively, the method may be used to remodel vaginal tissue, nasal tissue, oral tissue, and the like.

Alternatively, the method may include positioning a plurality of blades, such as two, three, or more blades, at the tissue surface. Optionally, as described above, the blade is configured on the head of the device. Optionally, the head is coupled with a flexible handle that is manually manipulated by a user. Optionally, the method may comprise: external pressure is applied to a flexible handle attached to the elongated head, such as flexible/curved handle 200 attached to either of elongated heads 100 and 401.

Optionally, the method comprises remodelling the tissue. Optionally, remodelling refers to altering tissue by peeling/removing the tissue. Optionally, the modifying comprises reducing the thickness of the tissue. For example, the thickness of the removed layer may vary between different portions of the corneal surface, e.g., thicker layers may be removed from the center of the cornea while thinner layers may be removed from the periphery. Alternatively, the thickness of the removed layer is constant and substantially uniform for different treated portions of the corneal surface. In some embodiments, the engineering includes remodelling the epithelium. Optionally, the modification does not affect the bowman's layer under the epithelium. For example, retrofitting includes removing at least a portion of the bowman's layer. In some embodiments, the modification does not damage the substrate.

Optionally, other epithelial tissue is modified, e.g., facial skin, any other skin tissue, vaginal tissue, oral tissue, etc.

Optionally, the modification is performed by harvesting tissue. In some embodiments, the remodeling is obtained by dissecting tissue. Optionally, the stripping is performed by moving a blade over the surface of the tissue. Optionally, the movement comprises a streaking movement, a glancing movement, a unidirectional movement, a bi-directional movement. In some embodiments, the blade slides over the tissue.

In some embodiments, the blade is configured to form a ramp in tissue during movement thereof, such as a ramp between the center of the cornea and the circular periphery of the cornea. Alternatively, the ramp angle ranges between 10-30 degrees, such as 12 degrees, 18 degrees, 25 degrees, or an intermediate, larger, or smaller angle. Potential advantages of creating a ramp by movement of the blade over the corneal surface may include inducing cell growth, which may, for example, increase the rate of healing of tissue after refractive surgery. Effects of the ramp may include a faster cell regeneration rate at the bottom of the ramp, e.g., at the center of the cornea, which increases the rate of healing.

Optionally, the removed tissue and/or fluid is collected, for example, into a funnel between the blades.

Optionally, the tissue surface is dried. In some embodiments, for example, as further described herein, drying is performed by: the fluid is collected during movement of the device over the tissue, for example, by use of one or more absorbent elements. Optionally, drying is achieved by draining the fluid by capillary action using a funnel defined between the blades.

Optionally, refractive surgery is performed after removal and/or other modification of the tissue, and/or once the tissue has dried (e.g., relative to the natural state of the cornea).

Fig. 5 is a front view of an exemplary head of a device for remodelling tissue, the device including or consisting of three blades, according to some embodiments of the invention.

In some embodiments, the head 401 includes a plurality of blade clips, such as clips 405 and 409, and at least one blade 407 as shown herein, disposed at the distal end of the head 401. In some embodiments, at least one blade 407 includes a distal contact surface or edge, such as contact surface 423. In some embodiments, two funnels are defined between adjacent blades and the wall of the base portion of clip strip, a first funnel 411 is defined between clip strip 409 and the base portion of blade 407, and a second funnel 413 is defined between clip strip 405 and the base portion of blade 407.

In some embodiments, funnels 411 and 413 extend in a proximal direction, for example, extending 1/8 to 1/2 of the height 415 of head 401, measured between the proximal and distal ends of the head.

In some embodiments, the clip strips 405 and 409 and at least one blade 407 are formed at different heights from each other (e.g., the heights are measured from the proximal end of the funnel formed between the blades to the contact surface of each blade/clip strip that engages the tissue). Optionally, the difference in height between the blade/clip strip determines the penetration depth of the blade relative to the tissue surface. In some embodiments, the blade and the clip strip are configured such that the clip strip limits the penetration depth of the at least one blade relative to the tissue surface. For example, as shown in this figure, the two outermost clip strips 405 and 409 respectively act as locating (also referred to as "control") clip strips for the intermediate blade 407 (which is a double edge). In some embodiments, the clip strip is formed to have a height 417 that is less than the height 419 of the middle blade 407, such as 10%, 20%, 30%, 40% less or a middle, greater or lesser percentage. Alternatively, the height 419 of intermediate blade 407 is in the range of, for example, between 2-3mm, such as 2mm, 2.2mm, 2.7mm, or an intermediate, longer or shorter height, while the height 417 of clip strip 405 is less than height 419, for example, 0.15-0.2mm less. In some embodiments, the height difference between the blade and the clip strip maintains a fixed positioning of the blade relative to the curved surface of the tissue. Potential advantages of one or more blades configured to limit the penetration depth of another blade may include preventing the blade from damaging deeper layers of tissue, such as the subcutaneous layer of tissue. Damage to deeper tissue layers may be caused by excessive pressure applied by the user while manipulating the device on the tissue, while a fixed location may provide additional safety, for example, by reducing such damage. Potential advantages of the blade arrangement also include reducing the effect of the force applied by the user on the depth of the blade within the epithelial fluid layer. Clip strip 405 and/or clip strip 409 function to stabilize blade 407 on the tissue surface. Alternatively, clip strip 405 acts to stabilize blade 407 when peeling is performed in a first direction, and clip strip 407 acts to stabilize blade 407 when peeling is performed in the opposite direction. Potentially, even uncontrolled movement of the device over the tissue does not cause substantial damage to deeper tissue layers and can reduce the risk of tearing corneal tissue during dissection.

In some embodiments, a guide clip strip, such as clip strip 405, defines an entry angle α of intermediate blade 407 relative to tissue. For example, the entry angle α is defined relative to a horizontal axis through a point or line formed by one of the edges of the contact surface 423 of the blade 407 (the edges being the left and right corners of the contact surface 423 as shown in the figures). Alternatively, the opening of the angle α is set by positioning the contact surface of the clip strip 505 relative to the horizontal axis. Alternatively, the angle α may range between 38-55 degrees, such as 40 degrees, 47 degrees, 52 degrees, or intermediate, larger, or smaller angles, for example.

In some embodiments, guide clip strips 405 and 409 are identical, forming a symmetrical head. Alternatively, guide clip strip 405 differs from guide clip strip 409 in the following respects: height and/or size of the contact surface or edge, and/or distance of the contact surface of the clip strip from the contact surface of intermediate blade 407. Alternatively, the asymmetric configuration of the head allows for a different treatment in one direction than in another, e.g., thicker layers of tissue are stripped when the head is moved in a first direction and thinner layers of tissue are stripped when the head is moved in a second direction. Optionally, the arrangement of the blades/strips and their respective heights, contact surfaces, distance between blades and/or other parameters are selected according to the morphology of the tissue surface.

In some embodiments, the device is moved over the cornea or any other tissue surface such as facial skin, cervix, throat, etc., to strip epithelial tissue. Alternatively, movement is performed in a plane tangential to the curvature of the cornea, for example in one or both directions (left and/or right) substantially transverse to the height 415 of the head 401. For the exemplary head shown in this figure, movement to the right will cause the right edge of contact surface 423 of blade 407 to strip off the epithelial tissue that will be collected within funnel 413, while movement to the left will cause the left edge to strip off the epithelial tissue that will be collected in funnel 411. The rightward movement is defined by: clip strip 405 is positioned relative to clip strip 407 and relative to the cornea or any other tissue surface, while movement to the left is defined by: clip strip 409 is positioned relative to blade 407 and relative to the cornea or any other tissue surface. Optionally, the stripped tissue is collected on the side walls of blade 407 as the device advances over the corneal surface, optionally accumulating within drainage funnels 411 and 413.

In some embodiments, the epithelial layer may be removed from a surface such as facial skin, cervix, throat, and the like. Thus, epithelial tissue stripped/removed from these surfaces may accumulate within drainage funnels 411 and 413.

In some embodiments, the blade walls defining funnels 411 and 413 include one or more slits (not shown in this figure). The effect of the slit is to increase the total surface area of the walls defining the funnel and may increase the capillary force of the funnel, thereby allowing fluid and/or removed tissue to adhere to the funnel and be sucked away from the corneal surface in a proximal direction. In some embodiments, the funnel is conical, including an opening that widens in the proximal direction. Potential advantages of the conical structure may include having the fluid and/or tissue adhere to the funnel wall and be sucked into the funnel at the contact area of the cornea with the funnel, wherein the diameter of the opening is relatively small. As the funnel widens in the proximal direction, capillary action may decrease.

In some embodiments, clip strips 405, 409 and/or blade 407 may comprise a biocompatible polymer. Alternatively, in some embodiments, the blade is composed of metal. Optionally, a high surface finish is used to make the metal blade to reduce inflammation and/or sculpting effects on the cornea. In some embodiments, the constituent material of the blade or the coating material has a hydrophilic nature, for example, in order to enhance the effect of collecting the fluid. In some embodiments, clip strips 405, 409 and/or blade 407 may comprise a polymer having a shore hardness between 20 and 90 SHD.

The terms "include" and "comprise" as well as "having" and their cognate words mean "including but not limited to".

The term "consisting of" means "including and limited to.

The term "consisting essentially of means that the composition, method, or structure may include additional ingredients, steps, and/or portions, provided that the additional ingredients, steps, and/or portions do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, the term "compound" or "at least one compound" may include a variety of compounds, including mixtures thereof.

Various embodiments of the invention may be presented throughout this application in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as a inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered as having specifically disclosed all possible subranges and individual values within the range. For example, a description of a range such as from 1 to 6 should be taken as a specific disclosure of a subrange such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual values within the range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the extent.

Reference is now made to fig. 6, which is a flow chart of a method for selectively dissecting epithelial tissue layers. In step 610, a device configured to selectively peel the layer (e.g., epithelial layer) may be provided. In some embodiments, the device may include an elongated head 100/401 and a handle 200.

In step 620, the designated epithelial tissue layer may be removed by moving a blade over the designated tissue using a handle.

In some embodiments, the epithelial tissue is a portion of facial skin. In this case, removing the layer may further include at least one of: removing senile plaque, removing shallow lesion, removing postoperative scar, etc.

In some embodiments, the epithelial tissue is the cervix. In some embodiments, the epithelial tissue is the esophagus (throat). In some embodiments, removing the layer further comprises at least one of: the removed layer is collected for pathological sampling and the removed layer is collected for smear squamous cell sampling, such as cervical smears, pharyngeal swabs, and the like. In some embodiments, the epithelial layer is collected by accumulating it in the cavity between guide clip strip 102/405 and blade 104/407, as described above with respect to FIG. 6. Thus, tissue stripped/removed from these surfaces may accumulate within cavities such as drainage funnels 411 and 413. In this case, the device 100/401 further comprises a second guiding strip 409 and the blade 407 is a double-sided blade, and two guiding strips 405 and 409 are provided on either side of the double-sided blade 407.

In some embodiments, at least one of the elongated edges is covered with a functional coating selected from the group consisting of: lubricating materials, pharmaceuticals, nutritional materials, moisturizing materials, and preservative materials. In some embodiments, the device is a disposable device, and as described above, wherein the scraping blade is made of a polymeric material having a shore hardness of between 20 and 90 SHD.

Some other embodiments of the invention may relate to a "kit" that may include a device (e.g., a device comprising an elongated head 100/401 and a handle 200) and at least one formulation according to any of the embodiments disclosed herein above. In some embodiments, the formulation may include active and inactive materials provided to the release surface. For example, if the peeling surface is facial skin, the formulation may include at least one of: a moisturizing ingredient selected from the group consisting of E, B1 vitamins, hyaluronic acid, retinol, perfume oil, plant extracts, and the like. In another example, if the peeled surface is a cervix, the formulation may include at least one of: moisture-keeping component, antibacterial component, antifungal component, etc.

Whenever a range of numbers is referred to herein, it is intended to include any reference number (fractional or integer) within the indicated range. In this document, the phrase "a range between/between a first indicator number and a second indicator number" and "a range from/between a first indicator number to a second indicator number" may be used interchangeably, the meaning of which includes the first indicator number and the second indicator number and all decimal and integer numbers therebetween.

As used herein, the term "method" refers to means, techniques, and procedures for accomplishing a given task including, but not limited to, means, techniques, and procedures known to, or readily developed from, those skilled in the art of chemistry, pharmacology, biology, biochemistry, and medicine.

As used herein, the term "treating" includes eliminating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating a clinical or aesthetic symptom of a condition, or substantially preventing the appearance of a clinical or aesthetic symptom of a condition.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or in any other described embodiment of the invention. Certain features described in the context of various embodiments should not be considered as essential features of these embodiments except in the following cases: embodiments are not effective in missing these elements. Aspects of the present invention are described herein with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer readable program instructions.

The flowcharts and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods and computer program products according to various embodiments of the present invention. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of instructions, which comprises one or more executable instructions for implementing the specified logical function(s). In some alternative embodiments, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may in fact be executed substantially concurrently or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems which perform the specified functions or acts, or combinations of special purpose hardware and computer instructions.

The description of the various embodiments of the present invention has been presented for purposes of illustration, but is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application, or the technical improvement over the prior art in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

Claims (37)

1. An apparatus, comprising:

an elongated head and a flexible handle,

wherein the flexible handle comprises at least one component configured to bend the flexible handle upon application of an external pressure and return the flexible handle to an initial position upon release of the external pressure.

2. The apparatus of claim 1, wherein the at least one component is selected from the group consisting of: at least a portion of the flexible handle, a spring and a connector made of an elastomeric material.

3. The device of claim 1 or 2, wherein the flexible handle is a replaceable handle.

4. A device according to any one of claims 1 to 3, wherein the flexible handle comprises a connector for detachably connecting the flexible handle to the elongate head.

5. The device of any one of claims 1-4, wherein the head is provided with one or more recesses configured to engage with the flexible handle, and wherein the recesses are provided at a proximal end of the head, while engaging with the flexible handle comprises not contacting a distal edge of a blade included in the elongate head.

6. The device of any one of claims 1 to 5, wherein the elongate head comprises one or more blades positioned substantially parallel to at least one guide clip strip, and wherein the elongate head has a length ranging between 1-100 millimeters and the distal end of the elongate head has a length ranging between 1-50 millimeters formed by the elongate edges of the one or more blades.

7. The device of claim 6, wherein the elongated edge of at least one blade is covered with a functional coating selected from the group consisting of: lubricating materials, pharmaceuticals, nutritional materials, moisturizing materials, and preservative materials.

8. The apparatus of claim 6, further comprising another guide clip strip, wherein the blade is a double sided blade, and wherein the guide clip strip is disposed on either side of the one or more blades.

9. A method for remodelling tissue, comprising:

applying external pressure to a flexible handle connected to an elongated head, wherein the flexible handle comprises at least one component configured to flex the flexible handle upon application of external pressure and return the flexible handle to its original position upon release of the external pressure.

10. The method of claim 9, wherein applying the external pressure is performed in motion while moving the elongate head over the tissue.

11. The method of claim 9 or 10, wherein the at least one component is selected from: at least a portion of the flexible handle, a spring and a connector made of an elastomeric material.

12. The method of claim 9 or 10, wherein the exfoliated portion of tissue is a corneal epithelium that does not include bowman's layer.

13. The method of claim 9 or 10, wherein the stripped portion of tissue is part of one of: vaginal tissue, oral tissue, and nasal tissue.

14. The method of any one of claims 9 to 13, further comprising collecting any exfoliated tissue and released residue in a funnel of the head.

15. The method of claim 14, wherein the released residue is a liquid.

16. The method of claim 14, wherein collecting comprises absorbing with an absorbent material at least partially coated on the funnel.

17. The method of any one of claims 9 to 16, further comprising orienting the elongate head relative to the tissue to define a penetration depth of an elongate edge of one or more blades of the elongate head into the tissue.

18. The method of any one of claims 9 to 17, wherein the one or more blades are positioned substantially parallel to one or more guide clips, and wherein the length of the elongate head ranges between 1-100 millimeters and the distal end of the elongate head has a length formed by the elongate edges of the one or more blades ranging between 1-50 millimeters.

19. The method of claim 17, further comprising: orienting the one or more guide clips and the one or more blades substantially parallel to a tangent to the tissue allows the one or more blades to penetrate to a relatively shallow depth and remove a thin layer of the tissue.

20. The method of claim 17, further comprising: the elongated one or more guide clips and one or more blades are oriented substantially perpendicular to the tangent to the tissue such that the elongated blade penetrates to a depth corresponding to a difference in height between the one or more guide clips and one or more blades and removes a layer of tissue corresponding to the penetration depth.

21. The method of any one of claims 17 to 20, wherein applying the external pressure comprises pressing the elongate edge of the one or more guide clips onto the tissue to flatten a surface of the tissue and enclose a portion of the flattened tissue within a gap to peel the tissue at a uniform thickness.

22. The method of any one of claims 9 to 11, further performing any one of the following after the peeling step: ophthalmic refractive surgery, treatment of myopia disorders, treatment of hyperopia disorders, treatment of astigmatism disorders, and treatment of keratoconus disorders.

23. An apparatus, comprising:

an elongated head and a curved handle bent at a predetermined angle between a central axis of a portion of the handle configured to be held by a user and a connection surface of a connector connecting the elongated head,

wherein the predetermined angle is 90-150 degrees relative to the head and the blade.

24. The device of claim 23, wherein the handle is a replaceable handle.

25. The device of claim 23 or 24, wherein the connector is configured to detachably connect the flexible handle to the elongate head.

26. A method of remodelling tissue, comprising:

an external pressure is applied to a curved handle connected to an elongated head, wherein the curved handle is curved at a predetermined angle between a central axis of a portion of the handle configured to be held by a user and a connection surface of a connector connecting the elongated head, and wherein the predetermined angle is 90-150 degrees relative to the head and the blade.

27. A method for selectively dissecting an epithelial tissue layer, comprising:

providing an apparatus, the apparatus comprising: an elongated head and a handle, wherein the elongated head comprises one or more blades positioned substantially parallel to at least one guide clip strip, and wherein the elongated head has a length ranging between 1-100 millimeters and a distal end of the elongated head has a length ranging between 1-50 millimeters formed by an elongated edge of the one or more blades; and

the epithelial tissue layer is removed by moving the one or more blades over the epithelial tissue using the handle.

28. The method of claim 27, wherein the epithelial tissue is a portion of facial skin.

29. The method of any of claims 27 to 28, wherein removing the layer further comprises at least one of: removing senile plaque, removing shallow lesions, and removing postoperative scar.

30. The method of any of claims 27 to 29, wherein removing the layer further comprises at least one of: the removed epithelium is collected for pathological sampling and the removed epithelium is collected for smear squamous cell sampling.

31. The method of claim 30, wherein at least one or more guide clips and the one or more blades.

32. The method of any one of claims 27 to 31, wherein the elongated edge of at least one blade is covered with a functional coating selected from the group consisting of: lubricating materials, pharmaceuticals, nutritional materials, moisturizing materials, and preservative materials.

33. The method of any one of claims 27 to 32, wherein the device further comprises one or more guide clips, wherein the one or more blades are single-sided or double-sided blades, and wherein the one or more guide clips are disposed on either side of the double-sided blades.

34. The method of any of claims 27-33, wherein the device is a disposable device, and wherein the one or more blades are made of a polymeric material having a shore hardness between 20 and 90 SHD.

35. An apparatus, comprising:

an elongated head and a handle,

wherein the elongate head comprises one or more blades positioned substantially parallel to at least one guide clip strip, and wherein the elongate head has a length in the range of 1-100 mm and the distal end of the elongate head has a length in the range of 1-50 mm formed by the elongate edges of the one or more blades, and

Wherein the one or more blades are made of a polymeric material having a shore hardness of between 20 and 90 SHD.

36. The device of claim 35, wherein the handle is a flexible handle.

37. The device of any one of claims 35 or 36, further comprising one or more guide clips, wherein at least one of the one or more blades is a double-sided blade, and wherein two guide clips are disposed on either side of the double-sided blade.