Patent Grant
11166743
In aesthetic medicine, elimination of excess tissue and/or skin laxity is an important concern that affects more than 25% of the U.S. population. Conventional surgical therapies (e.g., a face lift, brow lift, or breast lift) can be effective but are invasive, inconvenient, and expensive, while scarring limits the applicability of surgery to certain treatment sites.
Although minimally invasive methods are available, such methods are generally less effective than surgical methods. For example, methods using energy sources (e.g., laser, non-coherent light, radiofrequency, and ultrasound) can be effective at improving the architecture and texture of the skin but are less effective at tightening the skin or reducing skin laxity. In addition, tissue ablative methods that create micro-ablations with photo-thermal energy can generate a coagulation zone in tissue that interferes with closure of the ablation zones, thereby inhibiting tissue tightening. These methods also require longer patient healing times due to the biological reparative response to coagulated and dead tissue during the remodeling process. Also, laser ablation depth is typically limited by the depth of the laser beam focus. Ablation of deeper tissue layers than is possible with available laser systems is desirable for the treatment of scars, for example.
Other methods, such as the use of neurotoxins, for example, botulinum toxin, reduce the formation of dynamic wrinkles by paralysis of the injected muscles, but such toxins have minimal or no direct effect on skin tightness or laxity. Finally, dermal fillers, such as hyaluronic acid, can be injected in the dermal layer to smooth out wrinkles and improve contours, but such fillers do not directly tighten or reduce laxity of the skin. Thus, surgical therapies remain the gold standard for lifting and/or tightening skin, as compared to energy-based techniques (e.g., laser, radiofrequency, and ultrasound) and injection-based techniques (e.g., botulinum toxin and fillers such as hyaluronic acid- and collagen-based fillers).
Accordingly, there is a need for improved methods and devices that provide increased effectiveness over currently available minimally-invasive techniques while maintaining convenience, affordability, and accessibility to patients desiring tissue restoration.
This invention relates to hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods for cosmetic resurfacing of skin tissue by removing portions of the skin tissue. The invention features an apparatus for generating a cosmetic effect in the skin tissue that includes one or more hollow needles each having at least one prong. The apparatus may also include a mechanism for removing tissue portion(s) from the hollow needle(s).
In a first aspect, the invention features an apparatus for producing a cosmetic effect in a skin tissue that includes at least one hollow needle including at least a first prong provided at a distal end of the hollow needle, wherein an angle between a lateral side of the first prong and a longitudinal axis of the hollow needle is at least about 20 degrees, and wherein the hollow needle is configured to remove a portion of the skin tissue when the hollow needle is inserted into and withdrawn from the skin tissue.
In some embodiments of the first aspect of the invention, the angle between the lateral side of the first prong and the longitudinal axis of the hollow needle is between about 20 and about 40 degrees. In some embodiments, the angle between the lateral side of the first prong and the longitudinal axis of the hollow needle is about 30 degrees.
In some embodiments of the first aspect of the invention, the hollow needle further includes a second prong at the distal end of the hollow needle. In some embodiments, an angle between the lateral side of the second prong and the longitudinal axis of the hollow needle is at least about 20 degrees. In some embodiments, the angle between the lateral side of the second prong and the longitudinal axis of the hollow needle is between about 20 and about 40 degrees. In some embodiments, the lateral side of the second prong and the longitudinal axis of the hollow needle is about 30 degrees. In some embodiments, the angle between a lateral side of the second prong and a longitudinal axis of the hollow needle is less than about 20 degrees. In some embodiments, the angle between the lateral side of the second prong and the longitudinal axis of the hollow needle is between about 5 degrees and about 20 degrees.
In some embodiments, the first prong includes an edge. In some embodiments, each of the first and second prongs includes an edge.
In some embodiments, the first prong includes a flat tip. In some embodiments, each of the first and second prongs includes a flat tip. In some embodiments, the flat tip has a length and a width. In some embodiments, the length and/or the width is at an angle relative to the longitudinal axis of the hollow needle. In some embodiments, the length and/or the width is perpendicular to the longitudinal axis of the hollow needle.
In a second aspect, the invention features an apparatus for producing a cosmetic effect in a skin tissue that includes at least one hollow needle including at least a first prong provided at a distal end of the hollow needle, wherein the first prong includes a flat tip having at least two dimensions, and wherein the hollow needle is configured to remove a portion of the skin tissue when the hollow needle is inserted into and withdrawn from the skin tissue.
In some embodiments of the second aspect of the invention, the hollow needle further includes a second prong at the distal end of the hollow needle. In some embodiments, the second prong includes a flat tip.
In some embodiments, the flat tip has a length and a width. In some embodiments, the length and/or the width is at an angle relative to the longitudinal axis of the hollow needle. In some embodiments, the length and/or the width is perpendicular to the longitudinal axis of the hollow needle.
In some embodiments of the second aspect of the invention, an angle between a lateral side of the first prong and a longitudinal axis of the hollow needle is at least about 20 degrees. In some embodiments, the angle between the lateral side of the first prong and the longitudinal axis of the hollow needle is between about 20 and about 40 degrees. In some embodiments, the angle between the lateral side of the first prong and the longitudinal axis of the hollow needle is about 30 degrees. In some embodiments of the second aspect of the invention, an angle between a lateral side of the first prong and a longitudinal axis of the hollow needle is less than about 20 degrees. In some embodiments, the angle between the lateral side of the first prong and the longitudinal axis of the hollow needle is between about 5 degrees and about 20 degrees.
In some embodiments of the second aspect of the invention, an angle between the lateral side of the second prong and the longitudinal axis of the hollow needle is at least about 20 degrees. In some embodiments, the angle between the lateral side of the second prong and the longitudinal axis of the hollow needle is between about 20 and about 40 degrees. In some embodiments, the angle between the lateral side of the second prong and the longitudinal axis of the hollow needle is about 30 degrees. In some embodiments of the second aspect of the invention, an angle between a lateral side of the second prong and a longitudinal axis of the hollow needle is less than about 20 degrees. In some embodiments, the angle between the lateral side of the second prong and the longitudinal axis of the hollow needle is between about 5 degrees and about 20 degrees.
In some embodiments of the first and second aspects of the invention, the first prong of the hollow needle includes a tip micro-feature. In some embodiments, each of the first and second prongs of the hollow needle includes a tip micro-feature. In some embodiments, the tip micro-feature is a hole or a slit. In some embodiments, the slit is a rectangular-shaped slit, a square-shaped slit, a U-shaped slit, or a T-shaped slit. In some embodiments, the tip micro-feature intersects the inner wall of the hollow needle at a non-perpendicular angle.
In some embodiments of the first and second aspects of the invention, the apparatus includes a plurality of hollow needles. In some embodiments, the distance between adjacent hollow needles is about 15 mm or less.
In some embodiments of the first and second aspects of the invention, the hollow needle is treated with a coating. In some embodiments, the coating is selected from the group consisting of TiN, TiCN, TiAlN, ZrN, and a diamond-like carbon.
In some embodiments of the first and second aspects of the invention, the inner diameter of the hollow needle is between about 0.14 mm and 0.84 mm. In some embodiments, the inner diameter of the hollow needle is between about 0.24 mm and 0.40 mm.
In some embodiments of the first and second aspects of the invention, the gauge size of the hollow needle is between 18 and 30 gauge. In some embodiments, the gauge size of the hollow needle is between 22 and 25 gauge.
In some embodiments of the first and second aspects of the invention, the length of the hollow needle is between about 2 mm and about 5 mm.
In some embodiments of the first and second aspects of the invention, the hollow needle is configured to extend (i) into the dermal layer, (ii) through the entire dermal layer to the junction of the dermal layer and the subcutaneous fat layer, or (iii) into the subcutaneous fat layer.
In some embodiments of the first and second aspects of the invention, the apparatus is configured to remove an areal fraction of the skin tissue that is between about 0.01 to about 0.65. In some embodiments, the apparatus is configured to remove an areal fraction of the skin tissue that is between about 0.01 to about 0.05. In some embodiments, the apparatus is configured to remove an areal fraction of the skin tissue that is between about 0.02 to about 0.03 (e.g., about 0.025).
In some embodiments of the first and second aspects of the invention, the inner wall of the hollow needle has a surface roughness between about 150 and about 300 Rz.
In some embodiments of the first and second aspects of the invention, the hollow needle includes a lumen, wherein the apparatus further includes a tissue removal tool within the lumen of the hollow needle and wherein the tissue removal tool is configured to facilitate removal of portions of the skin tissue from the hollow needle. In some embodiments, the tissue removal tool is controllably translatable along the longitudinal axis of the hollow needle. In some embodiments, the tissue removal tool is a piston. In some embodiments, the piston includes a round tip at a distal end of the piston. In some embodiments, the portions of the skin tissue removed by the tissue removal tool from the lumen of the hollow needle are substantially intact tissue portions.
In some embodiments of the first and second aspects of the invention, the apparatus further includes an aspiration tube, wherein the aspiration tube is coupled to a low pressure source and a trap. In some embodiments, the aspiration tube is placed in close proximity to the distal end of the hollow needle and wherein the trap is configured to capture the portions of the skin tissue to be discarded. In some embodiments, the low pressure source is a vacuum pump.
In some embodiments of the first and second aspects of the invention, the apparatus further includes a low-pressure conduit coupled to the hollow needle, wherein the low-pressure conduit is connected to a low pressure source to generate suction in the hollow needle. In some embodiments, the low pressure source is a vacuum pump.
In some embodiments of the first and second aspects of the invention, the apparatus further includes at least one actuator. In some embodiments, the actuator: 1) is configured to displace the hollow needle back and forth along a direction substantially parallel to the axis of the hollow needle; and/or 2) is configured to translate the hollow needle over the skin tissue in one direction or two orthogonal directions. In some embodiments, the actuator is configured to displace the hollow needle back and forth along a direction substantially parallel to the axis of the hollow needle and to translate the hollow needle over the skin tissue in one direction or two orthogonal directions. In some embodiments, the actuator is coupled to the apparatus by a locking or connecting mechanism. In some embodiments, the locking or connecting mechanism is selected from the group consisting of a magnetic latch, a compression clamp, a sliding clamp, a rotating lock, a clasp latch, and a sliding-rotating lock.
In some embodiments of the first and second aspects of the invention, the apparatus further includes a cover. In some embodiments, the cover is coupled to the actuator by a locking or connecting mechanism. In some embodiments, the locking or connecting mechanism is selected from the group consisting of a magnetic latch, a compression clamp, a sliding clamp, a rotating lock, a clasp latch, and a sliding-rotating lock.
In some embodiments of the first and second aspects of the invention, the apparatus further includes a spacer. In some embodiments, the spacer is attached to the cover, positioned between the cover and the skin tissue, and/or configured to control the depth of insertion of the hollow needle.
In some embodiments of the first and second aspects of the invention, the apparatus is configured to produce an array pattern upon removal of the portions of the skin tissue. In some embodiments, the array pattern includes one or more rows or a semi-random spatial distribution.
In some embodiments of the first and second aspects of the invention, the hollow needle is repeatedly inserted into and withdrawn from the skin tissue.
In some embodiments of the first and second aspects of the invention, the first and/or second prong as described herein is resistant to curling.
In a third aspect, the invention features a method for producing a cosmetic effect in a skin tissue. The method includes producing a plurality of holes in the skin tissue using an apparatus described herein, wherein each hole is produced by removing a portion of the skin tissue.
In some embodiments of the third aspect of the invention, the diameter of each hole is between about 0.14 mm and 0.84 mm. In some embodiments, the diameter of each hole is between about 0.24 mm and 0.40 mm.
In some embodiments of the third aspect of the invention, a surface area fraction of the removed portions of the skin tissue is between about 0.01 to about 0.65. In some embodiments, the surface area fraction of the removed portions of the skin tissue is less than about 0.1, such as between about 0.01 to about 0.05. In some embodiments, the surface area fraction of the removed portions of the skin tissue is between about 0.02 to about 0.03 (e.g., 0.025).
In some embodiments of the third aspect of the invention, at least one of the holes extends (i) into the dermal layer, (ii) through the entire dermal layer to the junction of the dermal layer and the subcutaneous fat layer, or (iii) into the subcutaneous fat layer. In some embodiments, at least one of the holes extends to a depth of between about 2 mm and about 5 mm.
In some embodiments of the third aspect of the invention, an array pattern including one or more rows or a semi-random spatial distribution is generated by the plurality of holes.
In a fourth aspect, the invention provides a hollow needle including at least a first prong provided at a distal end of the hollow needle, wherein an angle (α) between a lateral side of the first prong and a longitudinal axis of the hollow needle is at least about 20 degrees, and wherein the hollow needle is configured to remove a portion of skin tissue when the hollow needle is inserted into and withdrawn from skin tissue.
In some embodiments of the fourth aspect of the invention, the angle (α) between the lateral side of the first prong and the longitudinal axis of the hollow needle is between about 20 and about 40 degrees. In some embodiments, the angle (α) between the lateral side of the first prong and the longitudinal axis of the hollow needle is about 30 degrees.
In some embodiments of the fourth aspect of the invention, the hollow needle further includes a second prong. In some embodiments, an angle (α) between a lateral side of the second prong and a longitudinal axis of the hollow needle is at least about 20 degrees. In some embodiments, the angle (α) between the lateral side of the second prong and the longitudinal axis of the hollow needle is between about 20 and about 40 degrees. In some embodiments, the angle (α) between the lateral side of the second prong and the longitudinal axis of the hollow needle is about 30 degrees. In some embodiments of the fourth aspect of the invention, an angle (α) between a lateral side of the second prong and a longitudinal axis of the hollow needle is less than about 20 degrees. In some embodiments, the angle (α) between the lateral side of the second prong and the longitudinal axis of the hollow needle is between about 5 degrees and about 20 degrees.
In some embodiments of the fourth aspect of the invention, the first prong includes an edge. In some embodiments, each of the first and second prongs includes an edge.
In some embodiments of the fourth aspect of the invention, the first prong includes a flat tip. In some embodiments, each of the first and second prongs includes a flat tip. In some embodiments, the flat tip has a length and a width. In some embodiments, the length and/or the width is at an angle relative to the longitudinal axis of the hollow needle. In some embodiments, the length and/or the width is perpendicular to the longitudinal axis of the hollow needle.
In a fifth aspect, the invention provides a hollow needle including at least a first prong provided at a distal end of the hollow needle, wherein the first prong includes a flat tip having at least two dimensions, and wherein the hollow needle is configured to remove a portion of skin tissue when the hollow needle is inserted into and withdrawn from skin tissue.
In some embodiments of the fifth aspect of the invention, the hollow needle further includes a second prong. In some embodiments, the second prong includes a flat tip. In some embodiments, the flat tip has a length and a width. In some embodiments, the length and/or the width is at an angle relative to the longitudinal axis of the hollow needle. In some embodiments, the length and/or the width is perpendicular to the longitudinal axis of the hollow needle.
In some embodiments of the fifth aspect of the invention, an angle (α) between a lateral side of the first prong and a longitudinal axis of the hollow needle is at least about 20 degrees. In some embodiments, the angle (α) between the lateral side of the first prong and the longitudinal axis of the hollow needle is between about 20 and about 40 degrees. In some embodiments, the angle (α) between the lateral side of the first prong and the longitudinal axis of the hollow needle is about 30 degrees. In some embodiments of the fifth aspect of the invention, an angle (α) between a lateral side of the first prong and a longitudinal axis of the hollow needle is less than about 20 degrees. In some embodiments, the angle (α) between the lateral side of the first prong and the longitudinal axis of the hollow needle is between about 5 degrees and about 20 degrees.
In some embodiments of the fifth aspect of the invention, an angle (α) between a lateral side of the second prong and a longitudinal axis of the hollow needle is at least about 20 degrees. In some embodiments, the angle (α) between the lateral side of the second prong and the longitudinal axis of the hollow needle is between about 20 and about 40 degrees. In some embodiments, the angle (α) between the lateral side of the second prong and the longitudinal axis of the hollow needle is about 30 degrees. In some embodiments of the fifth aspect of the invention, an angle (α) between a lateral side of the second prong and a longitudinal axis of the hollow needle is less than about 20 degrees. In some embodiments, the angle (α) between the lateral side of the second prong and the longitudinal axis of the hollow needle is between about 5 degrees and about 20 degrees.
In some embodiments of the fifth aspect of the invention, the first prong of the hollow needle includes a tip micro-feature. In some embodiments, each of the first and second prongs of the hollow needle includes a tip micro-feature. In some embodiments, the tip micro-feature is a hole or a slit. In some embodiments, the slit is a rectangular-shaped slit, a square-shaped slit, a U-shaped slit, or a T-shaped slit. In some embodiments, the tip micro-feature intersects the inner wall of the hollow needle at a non-perpendicular angle.
In some embodiments of the fourth and fifth aspects of the invention, the hollow needle is treated with a coating. In some embodiments, the coating is selected from the group consisting of TiN, TiCN, TiAlN, ZrN, and a diamond-like carbon.
In some embodiments of the fourth and fifth aspects of the invention, the hollow needle is repeatedly inserted into and withdrawn from the skin tissue.
In a sixth aspect, the invention features a needle assembly including a hollow needle, a z-actuator, and a tissue removal tool, wherein the hollow needle includes at least a first prong provided at a distal end of the hollow needle and wherein an angle (α) between a lateral side of the first prong and a longitudinal axis of the hollow needle is at least about 20 degrees.
In some embodiments of the sixth aspect of the invention, the hollow needle further includes a second prong. In some embodiments, an angle (α) between a lateral side of the second prong and a longitudinal axis of the hollow needle is at least about 20 degrees. In some embodiments, an angle (α) between a lateral side of the second prong and a longitudinal axis of the hollow needle is less than about 20 degrees.
In some embodiments of the sixth aspect, the first prong includes an edge. In some embodiments, each of the first and second prongs includes an edge. In some embodiments, the first prong includes a flat tip. In some embodiments, each of the first and second prongs includes a flat tip. In some embodiments, the flat tip has a length and a width. In some embodiments, the length and/or the width is at an angle relative to the longitudinal axis of the hollow needle. In some embodiments, the length and/or the width is perpendicular to the longitudinal axis of the hollow needle.
In some embodiments, the needle assembly of the sixth aspect of the invention further includes a support base, a scaffold, an aspiration tube, a trap, and/or a pressure generating source. In some embodiments, the needle assembly is configured to be detachably attached to an x- and/or y-actuator.
In a seventh aspect, the invention features a needle assembly including a hollow needle, a z-actuator, and a tissue removal tool, wherein the hollow needle includes at least a first prong provided at a distal end of the hollow needle and wherein the first prong includes a flat tip having at least two dimensions.
In some embodiments of the seventh aspect, the hollow needle further includes a second prong. In some embodiments, the second prong includes a flat tip. In some embodiments, the flat tip has a length and a width. In some embodiments, the length and/or the width is at an angle relative to the longitudinal axis of the hollow needle. In some embodiments, the length and/or the width is perpendicular to the longitudinal axis of the hollow needle.
In some embodiments of the seventh aspect, an angle (α) between a lateral side of the first prong and a longitudinal axis of the hollow needle is at least about 20 degrees. In some embodiments, an angle (a) between a lateral side of the first prong and a longitudinal axis of the hollow needle is less than about 20 degrees. In some embodiments of the seventh aspect, an angle (α) between a lateral side of the second prong and a longitudinal axis of the hollow needle is at least about 20 degrees. In some embodiments, an angle (α) between a lateral side of the second prong and a longitudinal axis of the hollow needle is less than about 20 degrees.
In some embodiments, the needle assembly of the seventh aspect of the invention further includes a support base, a scaffold, an aspiration tube, a trap, and/or a pressure generating source. In some embodiments, the needle assembly is configured to be detachably attached to an x- and/or y-actuator.
By “tissue portion” is meant that portion of skin and/or proximal tissue layers (e.g., epidermal layer, dermal layer, and subcutaneous fat layer) that is removed (e.g., as a plug) by a hollow needle of the apparatus. A tissue portion may have particular dimensions, geometry, and other characteristics that correspond to the particular dimensions, geometry, and other characteristics of a hollow needle of the apparatus of the invention.
By removal of a tissue portion that is “substantially intact” is meant that the tissue portion that is removed from the lumen of a hollow needle remains as an unbroken or whole tissue portion, i.e., the removed tissue portion has not been broken or separated into individual, smaller pieces or macerated.
By “about” is meant +/−10% of the recited value.
By “subject” is meant a mammal (e.g., a human or non-human mammal).
By “proximal” or “proximal end” is meant the end of the hollow needle that is away from or opposite the needle tip, e.g., the end of hollow needle 14 that is closer to z-actuator 12 and support base 11, as shown in
By “distal” or “distal end” is meant the end of the hollow needle that is at or close to the needle tip (e.g., needle tip 18 of
By “coring rate” is meant the percentage of hollow needle actuations that result in cored tissue removal from the treatment area out of the total number of hollow needle actuations. The hollow needles of the invention are designed to maximize coring rate and minimize hollow needle actuations that do not result in cored tissue removal. A tissue portion detaches from the skin when the coring force exceeds the tissue resistance force. The tissue resistance force is determined by the connection of the tissue portion to its surrounding tissue. For example, when the hollow needle is fully inserted through the dermal layer of the skin, the tissue resistance force is determined by the connection between the tissue portion in the lumen of the needle and the subcutaneous fat layer. The coring rate is determined by, e.g., the coring force of the hollow needle, the friction between the lumen wall of the hollow needle and the tissue portion, and the tissue resistance force. The coring rate may also be affected by applying a pressure differential across the hollow needle. For example, a vacuum applied at the proximal end of the hollow needle may aspirate the cored tissue portion from the hollow needle, thereby, increasing the coring rate.
By “coring force” is meant the force applied by the hollow needle of the apparatus to the cored tissue portion as the needle is being withdrawn from the skin. The coring force is determined by, e.g., the friction between the lumen wall of the hollow needle and the cored tissue portion as the needle is being withdrawn from the skin and the position, geometry, and orientation of micro-features in the hollow needle.
By “insertion force” is meant the force generated by the hollow needle on the skin as it is inserted into the skin. The insertion force is initially determined by the amount of force required to penetrate the tissue. Once the tissue is penetrated, the insertion force is determine by the friction between the needle walls (inner and outer) and the surrounding tissue, as well as the force required to separate the tissue at the tip of the needle.
Other features and advantages of the invention will be apparent from the following Detailed Description and the claims.
This invention relates to hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods for generating a cosmetic effect in the skin (e.g., eliminating tissue volume, tightening skin, and/or reducing skin laxity) by removing tissue portions from the skin. Without being bound by theory, this approach facilitates skin remodeling by debulking the skin tissue and by triggering biological responses that contribute to tissue resurfacing and remodeling. In particular, the invention relates to hollow needles, as well as related needle assemblies, apparatuses, kits, and methods, capable of coring tissue portions by capturing and retaining the tissue portions inside the lumen of the hollow needle after insertion into and withdrawal from the skin. The cored tissue portions can be removed from the lumen of the hollow needle and discarded. The process can be repeated to generate multiple cored skin tissue portions, in particular over a desired area of skin and located at chosen sites of the body of a subject. The hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods described herein provide increased effectiveness over currently available apparatuses and techniques while maintaining convenience, affordability, and accessibility to patients desiring tissue restoration.
Needles
The apparatus of the invention includes at least one hollow needle having at least a first prong. In some embodiments, an angle between a lateral side of the prong and a longitudinal axis of the hollow needle (e.g., a bevel angle α) is at least about 20 degrees (e.g., the bevel angle α may be greater than about 20 degrees, such as greater than 20 degrees, 22 degrees, 24 degrees, 26 degrees, 28 degrees, 30 degrees, 32 degrees, 34 degrees, 36 degrees, 38 degrees, and 40 degrees, or at an angle of about 20 to about 40 degrees, between 20 to 40 degrees, 20 to 38 degrees, 20 to 36 degrees, 20 to 34 degrees, 20 to 32 degrees, 20 to 30 degrees, 20 to 28 degrees, 20 to 26 degrees, 20 to 24 degrees, 20 to 22 degrees, 22 to 40 degrees, 24 to 40 degrees, 26 to 40 degrees, 28 to 40 degrees, 30 to 40 degrees, 32 to 40 degrees, 34 to 40 degrees, 36 to 40 degrees, and 38 to 40 degrees). In particular, an angle between a lateral side of the prong and a longitudinal axis of the hollow needle (e.g., a bevel angle α) is about 30 degrees.
In some embodiments, the tip of the prong of the hollow needle is an edge. In some embodiments, the tip of the prong of the hollow needle is a flat tip having at least two dimensions. In some embodiments, the prong of the hollow needle includes a tip micro-feature. The hollow needles of the invention are constructed to prevent frequent needle damage during use, such as needle tip curling and wear (e.g., becoming dull), needle heel degradation, and needle bending. The hollow needles of the invention are designed to maintain mechanical integrity and durability over a large number of actuation cycles (e.g., actuation cycles greater than 1,000, 2,000, 3,000, 4,000, 5,000, 6,000, 7,000, 8,000, 9,000, 1,0000, 11,000, 12,000, 13,000, 14,000, 15,000, or 20,000). Preferably, these needles also effectively remove tissue portions from the skin with high coring rate. To produce a cosmetic effect in the skin tissue, a hollow needle of the apparatus is inserted into the skin tissue, preferably to a pre-determined depth using a pre-determined force, such that the hollow needle removes a portion of the skin tissue by capturing the portion of the skin tissue in the lumen of the hollow needle.
Prongs
As shown in
The geometry of a prong at the distal end of a hollow needle can be characterized by a bevel angle. A bevel angle, e.g., angle α as shown in
A bevel angle α of at least about 20 degrees or more improves the mechanical integrity of the needle over several actuation cycles of insertion and withdrawal into skin tissue. Table 1 below shows that a two-prong hollow needle having a 2α bevel angle of 40 degrees (the bevel angle α of each prong is 20 degrees) reduces the occurrence of needle tip curling relative to a two-prong hollow needle having a 2α bevel angle of 20 degrees (the bevel angle α of each prong is 10 degrees). A total of 5 two-prong hollow needles each having a bevel angle α of 10° and 5 two-prong hollow needles each having a bevel angle α of 20° were tested.
Additionally,
The tip of a prong of a hollow needle may be of varying geometries. For example, the tip of a prong may have a sharp point (e.g., sharp point 51 as shown in
Gauges, Inner Diameters, and Lengths
A hollow needle of the apparatus of the invention may be of any gauge, including gauges of from 18 to 30 (e.g., 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, and 30 gauge). The gauges of a hollow needle may be from 22 to 25 (e.g., 22, 23, 24, and 25 gauge). A hollow needle of the apparatus may have an inner diameter of from about 0.14 mm to about 0.84 mm (e.g., 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.2, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.3, 0.31, 0.32, 0.33, 0.34, 0.35, 0.36, 0.37, 0.38, 0.39, 0.4, 0.41, 0.42, 0.43, 0.44, 0.45, 0.46, 0.47, 0.48, 0.49, 0.5, 0.51, 0.52, 0.53, 0.54, 0.55, 0.56, 0.57, 0.58, 0.59, 0.6, 0.61, 0.62, 0.63, 0.64, 0.65, 0.66, 0.67, 0.68, 0.69, 0.7, 0.71, 0.72, 0.73, 0.74, 0.75, 0.76, 0.77, 0.78, 0.79, 0.8, 0.81, 0.82, 0.83, and 0.84 mm). The inner diameter of a hollow needle refers to the diameter of the inner lumen of the hollow needle. The inner diameter of a hollow needle may be from about 0.24 mm to about 0.40 mm (e.g., 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.3, 0.31, 0.32, 0.33, 0.34, 0.35, 0.36, 0.37, 0.38, 0.39, and 0.4 mm). Accordingly, the diameter of a portion of skin tissue removed by a hollow needle of the apparatus (e.g., a cored tissue portion) generally corresponds to the inner diameter of the hollow needle.
In some embodiments, the outer and/or inner diameter of a hollow needle may vary across its lengths, such that the diameter of one region of the hollow needle may be different from the outer and/or inner diameter of another region of the same needle. The change in a diameter across the hollow needle may or may not be continuous. The hollow needle may or may not be entirely cylindrical. For example, one or more hollow needles may be rectangular, serrated, scalloped, and/or irregular in one or more dimensions and along some or all of their lengths. In some embodiments, the inner lumen diameter may vary along the length of a hollow needle. The invention also features a swaged hollow needle having a bevel angle α of at least 20 degrees (e.g., between about 20 and about 40 degrees (e.g., 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, or 40 degrees)) and a variable inner lumen diameter over its length.
A hollow needle of the apparatus may be of varying lengths and may have varying active lengths (e.g., the length of a hollow needle configured to penetrate the skin tissue). Active lengths may vary from about 0.5 mm to about 10 mm (e.g., 0.5, 0.6, 0.8, 1, 1.2, 1.4, 1.6, 1.8, 2, 2.2, 2.4, 2.6, 2.8, 3, 3.2, 3.4, 3.6, 3.8, 4, 4.2, 4.4, 4.6, 4.8, 5, 5.2, 5.4, 5.6, 5.8, 6, 6.2, 6.4, 6.6, 6.8, 7, 7.2, 7.4, 7.6, 7.8, 8, 8.2, 8.4, 8.6, 8.8, 9, 9.2, 9.4, 9.6, 9.8, and 10 mm) and may be selectable with manual or automatic controls (e.g., a scroll wheel or an actuation mechanism such as an electromagnetic actuator). Active lengths of a hollow needle may be adjusted and selected depending on the skin area needing treatment. For example, hollow needle with active lengths from about 0.5 mm to about 2 mm (e.g., 0.5, 0.6, 0.8, 1, 1.2, 1.4, 1.6, 1.8, and 2 mm) may be used to treat thin skin, e.g., skin of an eyelid. The thickness of the epidermal and dermal layers of the skin of an eyelid may be from about 0.5 mm to about 1 mm (e.g., 0.5, 0.6, 0.8, and 1). Hollow needles with active lengths from about 5 mm to about 10 mm (e.g., 5, 6, 7, 8, 9, and 10 mm) may be used to treat thick skin, e.g., skin of the back or scar tissue, which can be thicker than healthy skin tissue. The thickness of an epidermal layer of skin may be from about 0.05 to about 2 mm (e.g., 0.05 to 2, 0.05 to 1.95, 0.05 to 1.9, 0.05 to 1.85, 0.05 to 1.8, 0.05 to 1.75, 0.05 to 1.7, 0.05 to 1.65, 0.05 to 1.6, 0.05 to 1.55, 0.05 to 1.5, 0.05 to 1.45, 0.05 to 1.4, 0.05 to 1.35, 0.05 to 1.3, 0.05 to 1.25, 0.05 to 1.2, 0.05 to 1.15, 0.05 to 1.1, 0.05 to 1.05, 0.05 to 1, 0.05 to 0.95, 0.05 to 0.9, 0.05 to 0.85, 0.05 to 0.8, 0.05 to 0.75, 0.05 to 0.7, 0.05 to 0.65, 0.05 to 0.6, 0.05 to 0.55, 0.05 to 0.5, 0.05 to 0.45, 0.05 to 0.4, 0.05 to 0.35, 0.05 to 0.3, 0.05 to 0.25, 0.05 to 0.2, 0.05 to 0.15, 0.05 to 0.1, 0.1 to 2, 0.15 to 2, 0.2 to 2, 0.25 to 2, 0.3 to 2, 0.35 to 2, 0.4 to 2, 0.45 to 2, 0.5 to 2, 0.55 to 2, 0.6 to 2, 0.65 to 2, 0.7 to 2, 0.75 to 2, 0.8 to 2, 0.85 to 2, 0.9 to 2, 0.95 to 2, 1 to 2, 1.05 to 2, 1.15 to 2, 1.2 to 2, 1.25 to 2, 1.3 to 2, 1.35 to 2, 1.4 to 2, 1.45 to 2, 1.5 to 2, 1.55 to 2, 1.6 to 2, 1.65 to 2, 1.7 to 2, 1.75 to 2, 1.8 to 2, 1.85 to 2, 1.9 to 2, and 1.95 to 2 mm). The thickness of a dermal layer of skin may be from 2 to 8 mm (e.g., 2 to 8, 2 to 7.5, 2 to 7, 2 to 6.5, 2 to 6, 2 to 5.5, 2 to 5, 2 to 4.5, 2 to 4, 2 to 3.5, 2 to 3, 2 to 2.5, 2.5 to 8, 3 to 8, 3.5 to 8, 4 to 8, 4.5 to 8, 5 to 8, 5.5 to 8, 6 to 8, 6.5 to 8, 7 to 8, and 7.5 to 8 mm). Active lengths of a hollow needle may be adjusted and selected to penetrate the epidermal and/or the dermal layer of skin.
Active lengths of a hollow needle may also be adjusted using one or more spacers (see
Micro-Features
A hollow needle of the apparatus may include one or more micro-features. A micro-feature is an element of the hollow needle that functions to help the hollow needle to capture or “grab” the tissue portion to be removed. A micro-feature may increase the coring rate of the hollow needle. A micro-feature may be located anywhere along the active length of the hollow needle. As shown in
Micro-features may be of varying geometries. A micro-feature may be a hole (see hole 61 of
In some embodiments, a micro-feature may be a slit having a length and a width (e.g., a rectangular-shaped slit, a square-shaped slit, a U-shaped slit, or a T-shaped slit), in which the length or width may be from about 10 μm to about 1 mm (e.g., from 10 μm to 1 mm, 10 μm to 900 μm, 10 μm to 880 μm, 10 μm to 860 μm, 10 μm to 840 μm, 10 μm to 820 μm, 10 μm to 800 μm, 10 μm to 780 μm, 10 μm to 760 μm, 10 μm to 740 μm, 10 μm to 720 μm, 10 μm to 700 μm, 10 μm to 680 μm, 10 μm to 660 μm, 10 μm to 640 μm, 10 μm to 620 μm, 10 μm to 600 μm, 10 μm to 580 μm, 10 μm to 560 μm, 10 μm to 540 μm, 10 μm to 520 μm, 10 μm to 500 μm, 10 μm to 480 μm, 10 μm to 460 μm, 10 μm to 440 μm, 10 μm to 420 μm, 10 μm to 400 μm, 10 μm to 380 μm, 10 μm to 360 μm, 10 μm to 340 μm, 10 μm to 320 μm, 10 μm to 300 μm, 10 μm to 280 μm, 10 μm to 260 μm, 10 μm to 240 μm, 10 μm to 220 μm, 10 μm to 200 μm, 10 μm to 180 μm, 10 μm to 160 μm, 10 μm to 140 μm, 10 μm to 120 μm, 10 μm to 100 μm, 10 μm to 80 μm, 10 μm to 60 μm, 10 μm to 40 μm, 10 μm to 20 μm, 20 μm to 1 mm, 40 μm to 1 mm, 60 μm to 1 mm, 80 μm to 1 mm, 100 μm to 1 mm, 120 μm to 1 mm, 140 μm to 1 mm, 160 μm to 1 mm, 180 μm to 1 mm, 200 μm to 1 mm, 220 μm to 1 mm, 240 μm to 1 mm, 260 μm to 1 mm, 280 μm to 1 mm, 300 μm to 1 mm, 320 μm to 1 mm, 340 μm to 1 mm, 360 μm to 1 mm, 380 μm to 1 mm, 400 μm to 1 mm, 420 μm to 1 mm, 440 μm to 1 mm, 460 μm to 1 mm, 480 μm to 1 mm, 500 μm to 1 mm, 520 μm to 1 mm, 540 μm to 1 mm, 560 μm to 1 mm, 580 μm to 1 mm, 600 μm to 1 mm, 620 μm to 1 mm, 640 μm to 1 mm, 660 μm to 1 mm, 680 μm to 1 mm, 700 μm to 1 mm, 720 μm to 1 mm, 740 μm to 1 mm, 760 μm to 1 mm, 780 μm to 1 mm, 800 μm to 1 mm, 820 μm to 1 mm, 840 μm to 1 mm, 860 μm to 1 mm, 880 μm to 1 mm, 900 μm to 1 mm, 920 μm to 1 mm, 940 μm to 1 mm, 960 μm to 1 mm, and 980 μm to 1 mm).
The micro-features may be designed and constructed to have a directional effect on the tissue portion captured inside the lumen of the hollow needle. For example, the shape and orientation of the micro-feature may affect the coring force of the hollow needle. As shown in
Needle Coating
A hollow needle of the apparatus may be coated with a material (e.g., a hard material) that improves or maintains the mechanical integrity, durability, and reliability of the hollow needle. The coating material may help to prevent damage, abrasion, and wear and tear of the needle tip and heel during repeated insertions into and withdrawals from skin tissue. Examples of materials (e.g., a hard material) that may be used to coat a hollow needle of the apparatus include, but are not limited to, TiN, TiCN, TiAlN, ZrN, and diamond-like carbon (DLC). The hard material may be applied as a coating to the outside surface of a hollow needle, the inner surface (e.g., the surface of the inner lumen) of a hollow needle, or both surfaces.
Surface of Needle Lumen
The lumen surface of a hollow needle may affect the coring force, coring rate, and insertion force of the hollow needle. In particular, the friction between the lumen surface and a cored tissue portion may determine the coring force, coring rate, and insertion force. The hollow needles described herein are designed to maximize coring rate and minimize hollow needle insertions that do not result in cored tissue removal. A tissue portion detaches from the skin when the coring force (e.g., the force applied by the hollow needle of the apparatus to the cored tissue portion as the needle is being withdrawn from the skin) exceeds the tissue resistance force, which is determined by the connection of the tissue portion to its surrounding tissue. For example, when the hollow needle is fully inserted through the dermal layer of the skin, the tissue resistance force is determined by the connection between the tissue portion in the lumen of the needle and the subcutaneous fat layer. Accordingly, when the coring force exceeds the tissue resistance force, the cored tissue portion is captured in the lumen of the hollow needle and removed from the skin (
In some embodiments, hollow needles and methods of the invention may have a coring rate of at least about 5% (e.g., from about 5% to about 100%, such as 5% to 100%, 5% to 95%, 5% to 90%, 5% to 85%, 5% to 80%, 5% to 75%, 5% to 70%, 5% to 65%, 5% to 60%, 5% to 55%, 5% to 50%, 5% to 45%, 5% to 40%, 5% to 35%, 5% to 30%, 5% to 25%, 5% to 20%, 5% to 15%, 5% to 10%, 10% to 95%, 15% to 95%, 20% to 95%, 25% to 95%, 30% to 95%, 35% to 95%, 40% to 95%, 45% to 95%, 50% to 95%, 55% to 95%, 60% to 95%, 65% to 95%, 70% to 95%, 75% to 95%, 80% to 95%, 85% to 95%, and 90% to 95%).
In some embodiments, hollow needles and methods of the invention may have a coring force of about 3 N to about 10 N (e.g., 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, and 10 N). In some embodiments, a two-prong hollow needle having a bevel angle α of 20 degrees may have a coring force of about 3 N to about 10 N (e.g., 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, and 10 N).
A coating material and/or a lubricant may affect the degree of roughness of the lumen surface, and thus the friction between the lumen surface and a cored tissue portion. The lumen surface of a hollow needle may be polished by running a lubricant or a polishing media though the hollow needle to reduce the roughness of the lumen surface. Examples of lubricants include, but are not limited to, salt-based lubricants (e.g., buffered saline solutions (e.g., PBS)), sugar-based lubricants (e.g., sucrose and glucose solutions), and surfactant-based lubricants (e.g., solutions containing Tween20). The degree of roughness of the lumen surface of the hollow needle may also be affected by the manufacturing process used to make the hollow needle. Table 2 below shows lumen surface roughness measured in Ra (arithmetic average of roughness profile) and Rz (means roughness depth) of hollow needles made using single plug, double plug, and sunk manufacturing processes. The lumen surface of hollow needles made using double plug process is smoother (lower Ra and Rz values) than the lumen surface of hollow needles made using single plug process.
Needle Manufacture
A hollow needle of the apparatus may be made using available manufacturing techniques and processes. For example, manufacturing of a hollow needle starts with drawing the needle hypodermic tube, followed by forming the needle tip. The needle hypodermic tube may be drawn using manufacturing processes, e.g., single plug, double plug, and sunk. The needle tip may be formed by grinding. For example, a hollow needle having one prong may be formed by grinding one side of the distal end of the hollow needle at an angle relative to the longitudinal axis of the hollow needle. Similarly, a hollow needle having two prongs may be formed by grinding opposite sides of the distal end of the hollow needle at an angle relative to the longitudinal axis of the hollow needle. The grinding process may be performed at a low temperature to prevent or reduce annealing of the needle material and to prevent the needle material from undergoing phase transitions at high temperatures (e.g., at alloy transition temperature, which is defined by the alloy stoichiometry). Annealed material may become ductile and more prone to bending, which may reduce the durability and mechanical integrity of the hollow needle. Maintaining a low temperature (e.g., a temperature lower than the alloy transition temperature) during the grinding process may be achieved by, e.g., reducing the grinding speed and/or grinding rate and using a cooling fluid (e.g., periodically submerging the needle material and/or the grinding machinery in a cooling fluid). In some embodiments, the cooling fluid used may be at room temperature. Other non-grinding techniques and processes may also be used to manufacture the hollow needle(s) of the apparatus, e.g., electrical discharge machining.
Needle Assembly
Needle assembly 10 may include additional components, such as tubing and/or cables to couple various components and device control electronics, a power supply (e.g., an alternator and/or battery component), and/or a user interface. The components of the needle assembly may be detachably engaged for easy and quick connection and disconnection. The components of the needle assembly may be readily cleaned, sterilized (e.g., by steam sterilization or other known methods), and/or replaced. The components of the needle assembly may be provided to an operator (e.g., a doctor or surgeon) in sterile condition prior to use on a patient and many, if not all, of the components can be re-sterilized or replaced with sterile components prior to a subsequent use. For example, components of the needle assembly and/or the entire needle assembly may be readily removable from the apparatus for sterilization or replacement after use of the apparatus.
Z-actuator (e.g., a voice coil) 12 is configured to couple with hollow needle 14 in needle assembly 10. Z-actuator (e.g., a voice coil) 12 may have a locking mechanism to secure the hollow needle 14 in place during operation. In some embodiments, z-actuator 12 and hollow needle 14 may be locked by establishing a magnetic connection between the two. In other embodiments, z-actuator 12 and hollow needle 14 may be locked by establishing a mechanical connection between the two using, e.g., quick-connect clasps. The z-actuator-hollow needle locking mechanism may be detachably engaged for easy and quick connection and disconnection. The z-actuator-hollow needle locking mechanism may include one or more of adhesive, magnetic, electrical, and/or mechanical components (e.g., one or more gaskets, o-rings, septa, springs, clasps, and other engagement members). In some embodiments, the z-actuator may include a groove or depression for placement of an o-ring (e.g., a viton o-ring, a nitrile rubber o-ring, and a thermoplastic polyurethane o-ring) that will allow for a seal to form between z-actuator 12 and hollow needle 14. The portion of hollow needle 14 engineered to engage with z-actuator 12 may include a corresponding groove or depression. In other embodiments, a locking mechanism may involve mated pieces made of molded plastic. As an example, hollow needle 14 may form a seal by sliding partway into z-actuator 12. Z-actuator 12 and hollow needle 14 may also include interlocking ridges (e.g., made of plastic, rubber, or other material) to enhance or form a seal between the components. Z-actuator 12 may also feature a mechanism to activate detachment of hollow needle 14 from z-actuator 12. This mechanism may include one or more of a button, key, switch, toggle, spin-wheel, touch screen, and/or sliding lock. The detachment mechanism may be a quick-release mechanism. In some embodiments, one component (e.g., z-actuator 12) includes a depressible portion that engages a seal when the other component (e.g., hollow needle 14) is slid into the other. Depression of the portion may be disengaged by activation of a sliding lock, eliminating the seal between the components to allow their separation and, e.g., removal and replacement of hollow needle 14.
Needle assembly 10 may also include a power supply or be detachably attached to a power supply. For example, needle assembly 10 may have a holder for batteries that power operation of the apparatus or may be configured to receive an element including batteries. The holder may be configured to charge the batteries (e.g., when depleted) with a paired charging station, without requiring removal of the batteries, or the batteries may be removed from the apparatus for replacement or charging. In another embodiment, needle assembly 10 may include electronics and components (e.g., a power cord) that allow it to be powered from an external power supply, such as a direct or alternating current supply or a generator.
Mechanisms for Removal of Cored Tissue Portion from Hollow Needle
Cored tissue portion(s) may require removal from the lumen of a hollow needle of the apparatus after the needle containing the cored tissue portion inside its lumen is withdrawn from the skin, e.g., in order to continue the skin treatment procedure. The cored tissue portion may be removed from the needle lumen after each actuation cycle or after multiple actuation cycles. In some embodiments, a tissue removal tool (e.g., a piston) may be inserted from the proximal end (e.g., the end opposite the needle tip) of the hollow needle to push out the cored tissue portion. In some embodiments, the cored tissue portion may be removed through the distal end of the hollow needle (e.g., at the needle tip) using an aspiration tube coupled to a pressure generating source (e.g., a vacuum). The cored tissue portion may also be removed through the proximal end of the hollow needle by applying a differential pressure (e.g., a vacuum) or out of the distal end of the needle using compressed air or a pressurized fluid to push the cored tissue portion out of the distal end.
Tissue Removal Tool
A tissue removal tool may be used to push the cored tissue portion out of the lumen of a hollow needle. A tissue removal tool may be a piston or a pin that can fit inside the lumen of the hollow needle (e.g., without creating a vacuum inside the lumen (e.g., the gap between the tissue removal tool and the wall of the lumen of the hollow needle is large enough to allow the passage of air)). In a preferred embodiment, the tissue removal tool is a piston. A tissue removal tool (e.g., a piston) does not disrupt the structural integrity of the cored tissue portion. In some embodiments, a tissue removal tool (e.g., a piston) may push the cored tissue portion out of the lumen of a hollow needle as a substantially intact, cored tissue portion (see, e.g., cored tissue portion 74 at needle tip 18 in
A piston may be of varying geometry. The cross-section of the piston may be, e.g., round, oval, rectangular, or square. In a preferred embodiment, the cross-section of the piston is round. The geometry of the piston matches the shape of the lumen of the hollow needle such that the piston fits well inside the lumen and is able to freely slide along the longitudinal axis of the hollow needle, for example, without creating a vacuum. The piston may have a diameter that is less than the inner diameter of the hollow needle (e.g., a diameter that is 0.01% to 10% less (e.g., 0.01%, 0.05%, 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%, 0.4%, 0.45%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.5%, 8%, 8.5%, 9%, 9.5%, or 10% less). The end of the piston, which touches the cored tissue portion as the piston pushes the cored tissue portion out of or towards the distal end of the needle, may be round or flat. For example, as shown in
The piston may stay at a constant position. In this example, the hollow needle is moved up and down to engage the stationary piston. The piston may be inserted and withdrawn from the lumen of a hollow needle. As shown in
In another example, after hollow needle 14 containing a cored tissue portion inside its lumen is withdrawn from the skin, tissue removal tool (e.g., a piston) 13 moves down towards to the end of hollow needle 14 and enters the needle lumen through the proximal end of the needle. In this example, hollow needle 14 containing the cored tissue portion stays stationary while tissue removal tool (e.g., a piston) 13 moves downward to needle tip 18, thereby pushing the cored tissue portion towards or out from needle tip 18. The length of tissue removal tool (e.g., a piston) 13 may be adjusted to allow the cored tissue portion to be pushed towards or out of needle tip 18 while the needle is in its uppermost position and not penetrating into the skin. One or more actuators (e.g., the x-, y-, and/or z-actuator) (e.g., actuation unit 151 including x- and y-actuators shown in
An aspiration tube (e.g., aspiration tube 15 shown in
As shown in
Differential Pressure
A cored tissue portion inside the lumen of a hollow needle may be collected at the proximal or distal end of the needle by applying a differential pressure across the needle. In one embodiment, after the needle containing the cored tissue portion inside its lumen is withdrawn from the skin, the needle may move to a dock station or a separate unit, which may contain a pressure generating source (e.g., a vacuum pump) that provides suction and/or vacuum at the proximal end of the needle. Suction and/or vacuum may be applied at the proximal end of the hollow needle to pull the cored tissue portion out of the needle from its proximal end. A trap may be installed at the proximal end of the needle and between the needle and the pressure generating source (e.g., a vacuum pump) to collect the cored tissue portions for disposal, subsequent use (e.g., tissue graft or growth), or biochemical analysis and to prevent the cored tissue portions from entering the pressure generating source (e.g., a vacuum pump). In some embodiments, a differential pressure may be applied to a hollow needle (e.g., a swaged hollow needle having a variable inner lumen diameter over its length and a bevel angle α of at least 20 degrees (e.g., swaged hollow needle 54)). Tissue removal may be facilitated by increasing the inner lumen diameter in the direction of the tissue removal. An increased inner lumen diameter in part of a hollow needle (e.g., a swaged hollow needle having a variable inner lumen diameter over its length and a bevel angle α of at least 20 degrees (e.g., swaged hollow needle 54)) may reduce the friction between the cored tissue portion and the wall of the needle lumen. For example, suction and/or vacuum may be applied at the proximal end of a hollow needle (e.g., a swaged hollow needle having a variable inner lumen diameter over its length and a bevel angle α of at least 20 degrees (e.g., swaged hollow needle 54)) to pull the cored tissue portion out from the proximal end.
In another arrangement, a burst of high pressure may be applied at the proximal end of a hollow needle to pull the cored tissue portion out of the needle from its proximal end. As illustrated in
In another embodiment, after the needle containing the cored tissue portion inside its lumen is withdrawn from the skin, a pressure generating source (e.g., a vacuum pump) providing suction and/or vacuum may be placed proximal to the distal end of the needle. Suction and/or vacuum may be applied at the distal end of the hollow needle to pull the cored tissue portion out of the needle from its distal end.
In another embodiment, after the needle containing the cored tissue portion inside its lumen is withdrawn from the skin, a tissue removal tool (e.g., tissue removal tool (e.g., a piston) 13) may be used to push the cored tissue portion out of or towards the distal end of the needle. Once the cored tissue portion is at the distal end of the needle (e.g.,
Non-limiting possible pressures for a pressure generating source (e.g., a vacuum pump) to provide suction and/or vacuum at the proximal or distal end of a hollow needle to remove a cored tissue portion from the needle lumen include from about −8 mmHg to about −16 mmHg (e.g., −8, −9, −10, −11, −12, −13, −14, −15, and −16 mmHg). For example, the minimal air flow rate in the aspiration line of a pressure generating source (e.g., a vacuum pump) is from about 1 cubic feet per minute (CFM) to about 6 CFM (e.g., 1, 2, 3, 4, 5, and 6 CFM (e.g., 3 CFM)).
Tissue Pressure
A cored tissue portion inside the lumen of a hollow needle may be pushed out of the proximal end of the needle by the insertion of one or more new tissue portions during the subsequent actuation cycles. The inner wall of the hollow needle may be lubricated by, e.g., a sterile saline solution, to prevent clogging of the needle as multiple tissue portions are inserted into the needle. Also, a trap may be attached at the proximal end of the needle to collect the cored tissue portions as they are being pushed out of the needle for disposal, subsequent use (e.g., tissue graft or growth), or biochemical analysis.
Compressed Air or Pressurized Liquid
A cored tissue portion inside the lumen of the needle may be removed from the needle by applying compressed air or a pressurized fluid (e.g., a sterile saline solution) through the needle. Compressed air or pressurized fluid may be applied through the proximal end to push the cored tissue portion out from the distal end of the needle.
Other Mechanisms for Removal of Cored Tissue Portion
A cored tissue portion inside the lumen of the needle may also be removed from the needle using a heating element coupled to the needle. For example, a heating element coupled to the needle may be actuated which causes the needle to heat up to facilitate separation of the cored tissue portion from the surrounding skin. The cored tissue portion may be dried or desiccated prior to being removed from the lumen of the hollow needle. A vacuum source may then be applied to remove the heated cored tissue portion.
Pressure Generating Source
The apparatus may further include or be otherwise coupled to a pressure generating source. A pressure generating source may be applied to remove and/or collect cored tissue portions from the lumen of a hollow needle to prevent needle clogging during operation. In one embodiment, suction and/or vacuum may be applied via a hollow needle of the apparatus. A hollow needle and a pressure generating source (e.g., a vacuum pump) may be configured to remove and/or collect cored tissue portions from the lumen of the hollow needle by providing suction and/or vacuum after penetration of the hollow needle into the skin but before removal of the hollow needle from the skin. Following penetration into the tissue by a hollow needle, vacuum may be applied to draw the tissue portion in the lumen of the hollow needle from a treated skin area through the proximal end of the hollow needle and through tubing coupling the hollow needle to the pressure generating source (e.g., a vacuum pump). A trap may be installed between the proximal end of the hollow needle and the pressure generating source (e.g., a vacuum pump) to prevent the tissue portion from entering the pressure generating source (e.g., a vacuum pump). The pressure generating source (e.g., a vacuum pump) may also be activated after the hollow needle containing the tissue portion in the lumen is removed from the skin.
Alternatively, the pressure generating source (e.g., a vacuum pump) may be integrated with a separate aspiration tube. For example, as described previously and shown in
The pressure generating source may be a low pressure generating source. For example, the pressure generating source may be capable of providing vacuum and/or suction. Vacuum sources may include one or more rotary pumps, momentum transfer pumps, diffusion pumps, scroll pumps, and/or diaphragm pumps. In some embodiments, a low pressure generating source may include a house or central vacuum system. In other embodiments, a suction source may include a wall or portable suction device. In some embodiments, a vacuum source provides an absolute pressure less than about 6.3 kPa (e.g., from about 0.1 kPa to about 6 kPa, such as from 0.1 kPa to 6 kPa, 0.1 kPa to 5 kPa, 0.1 kPa to 4 kPa, 0.1 kPa to 3 kPa, 0.1 kPa to 2 kPa, 0.1 kPa to 1 kPa, 0.5 kPa to 6 kPa, 0.5 kPa to 5 kPa, 0.5 kPa to 4 kPa, 0.5 kPa to 3 kPa, 0.5 kPa to 2 kPa, 0.5 kPa to 1 kPa, 1 kPa to 6 kPa, 1 kPa to 5 kPa, 1 kPa to 4 kPa, 1 kPa to 3 kPa, 1 kPa to 2 kPa, 1.5 kPa to 6 kPa, 1.5 kPa to 5 kPa, 1.5 kPa to 4 kPa, 1.5 kPa to 3 kPa, and 1.5 kPa to 2 kPa).
Spacer
An apparatus of the invention may include one or more spacers that function to control the depth of penetration of a hollow needle. Skin thickness varies significantly between body sites and in some cases, between subjects. Tissue penetration depth is important to ensure coring tissue portions of the appropriate size and to avoid injury to tissue layers beyond the subcutaneous fat layer (e.g., muscle layer). One or more spacers may be attached to the apparatus, e.g., between the cover of the apparatus and the skin (see
Depending on the area of the skin tissue and/or the subject, spacers of different thicknesses may be placed at the distal end of the apparatus (e.g., on the end of a cover attached to the apparatus) to allow different depths of tissue penetration. In some embodiments, a spacer may have a thickness of from about 0.01 mm to about 10 mm (e.g., from 0.1 mm to 10 mm, 0.1 mm to 9.5 mm, 0.1 mm to 9 mm, 0.1 mm to 8.5 mm, 0.1 mm to 8 mm, 0.1 mm to 7.5 mm, 0.1 mm to 7 mm, 0.1 mm to 6.5 mm, 0.1 mm to 6 mm, 0.1 mm to 5.5 mm, 0.1 mm to 5 mm, 0.1 mm to 4.5 mm, 0.1 mm to 4 mm, 0.1 mm to 3.5 mm, 0.1 mm to 3 mm, 0.1 mm to 2.5 mm, 0.1 mm to 2 mm, 0.1 mm to 1.5 mm, 0.1 mm to 1 mm, 0.1 mm to 0.5 mm, 0.1 mm to 10 mm, 0.5 mm to 10 mm, 1 mm to 10 mm, 1.5 mm to 10 mm, 2 mm to 10 mm, 2.5 mm to 10 mm, 3 mm to 10 mm, 3.5 mm to 10 mm, 4 mm to 10 mm, 4.5 mm to 10 mm, 5 mm to 10 mm, 5.5 mm to 10 mm, 6 mm to 10 mm, 6.5 mm to 10 mm, 7 mm to 10 mm, 7.5 mm to 10 mm, 8 mm to 10 mm, 8.5 mm to 10 mm, 9 mm to 10 mm, and 9.5 mm to 10 mm)
Actuation, Translation, and Position Detection Mechanisms
The apparatus may further include actuation mechanisms to drive a hollow needle into or across the skin. In some embodiments, an actuation unit of the apparatus of the invention may include x-, y-, and z-actuators. Alternatively, an actuation unit of the apparatus of the invention (e.g., actuation unit 151 shown in
A “z” actuator may drive penetration into the skin by a hollow needle and/or retraction of the hollow needle after insertion. In some embodiments, a z-actuator (e.g., a voice coil) is part of the needle assembly of the apparatus (e.g., z-actuator 12 of needle assembly 10 shown in
The z-actuator may also be capable of operating at a high speed to minimize treatment time and deflection of the skin during the penetration of the hollow needle. In some embodiments, one actuation cycle in the z-direction takes from about 5 milliseconds to about 50 milliseconds (e.g., 5, 10, 15, 20, 25, 30, 35, 40, 45, and 50 milliseconds). In some embodiments, the z-actuator takes about 20 to about 35 milliseconds (e.g., 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, and 35 milliseconds) to travel about 20 mm to about 30 mm (e.g., 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, and 30 mm) downward into the skin tissue. In some embodiments, the z-actuator takes about 25 milliseconds to about 30 milliseconds (e.g., 25, 26, 27, 28, 29, and 30 milliseconds) to travel about 23 mm downward into the skin tissue. In some embodiments, the z-actuator takes about 25 to about 35 milliseconds (e.g., 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, and 35 milliseconds (e.g., 30 milliseconds)) to travel about 20 mm to about 30 mm (e.g., 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, and 30 mm (e.g., 23 mm)) upward from a penetration depth of about 20 mm to about 30 mm (e.g., 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, and 30 mm (e.g., 23 mm)) into the skin tissue. In some embodiments, the z-actuator takes about 30 milliseconds to travel about 23 mm upward from the penetrated skin tissue.
The z-actuator may further be capable of operating with relatively high insertion force. In some embodiments, a force of about 0.5 N to about 20 N (e.g., 0.5 N to 0.75 N, 0.5 N to 1 N, 0.5 N to 1.25 N, 0.5 N to 1.5 N, 0.5 N to 2 N, 0.5 N to 5 N, 0.5 N to 10 N, 0.5 N to 12 N, 0.5 N to 15 N, 0.5 N to 20 N, 0.75 N to 1 N, 0.75 N to 1.25 N, 0.75 N to 1.5 N, 0.75 N to 2 N, 0.75 N to 5 N, 0.75 N to 10 N, 0.75 N to 12 N, 0.75 N to 15 N, 0.75 N to 20 N, 1 N to 1.25 N, 1 N to 1.5 N, 1 N to 2 N, 1 N to 5 N, 1 N to 10 N, 1 N to 12 N, 1 N to 15 N, 1 N to 20 N, 1.25 N to 1.5 N, 1.25 N to 2 N, 1.25 N to 5 N, 1.25 N to 10 N, 1.25 N to 12 N, 1.25 N to 15 N, 1.25 N to 20 N, 1.5 N to 2 N, 1.5 N to 5 N, 1.5 N to 10 N, 1.5 N to 12 N, 1.5 N to 15 N, 1.5 N to 20 N, 2 N to 5 N, 2 N to 10 N, 2 N to 12 N, 2 N to 15 N, 2 N to 20 N, 5 N to 10 N, 5 N to 12 N, 5 N to 15 N, 5 N to 20 N, 10 N to 12 N, 10 N to 15 N, 10 N to 20 N, 12 N to 15 N, 12 N to 20 N, and 15 N to 20 N) per hollow needle can be applied to ensure insertion of the hollow needle into the skin. In some embodiments, a force of about 10 N to 20 N (e.g., 15 N) per hollow needle can be applied to ensure insertion of the hollow needle into the skin. The insertion force may be inversely correlated with needle gauge. For example, a 24 gauge needle may be operated with an insertion force of 12 N, while a 20 gauge needle may be operated with a higher insertion force. The z-actuator may also be capable of maintaining the apparatus at a low temperature (e.g., less than about 43° C., such as less than about 43, 42, 41, 40, 39, 38, 37, 36, or 35° C.) to avoid patient and user discomfort and/or to avoid damage to the skin tissue (e.g., collagen in the skin tissue is sensitive to high temperatures). Actuator types having these characteristics include voice coil (VC) actuators, pneumatic actuators, electromagnetic actuators, motors with cams, motors with lead screws (e.g., stepper motors), and piezoelectric actuators. In some embodiments, the z-actuator is a VC actuator.
The apparatus may include an “x” and/or “y” actuator for translating a hollow needle across the skin. The x/y-actuator may be used to establish the skin treatment coverage. In some embodiments, the x/y-actuator may be characterized by a small displacement range (e.g., less than about 10 mm (e.g., 10, 9, 8, 7, 6, 5, 4, 3, 2, and 1 mm)). In some embodiments, the x/y-actuator may be characterized by a relatively large displacement range (e.g., up to about 30 mm). The x/y-actuator may operate with high positional accuracy. For example, x/y-actuator may position the hollow needle to penetrate the skin within a 30 μm radius (e.g., within 30, 25, 20, 15, 10, or 5 μm) of a selected position. The x/y-actuator may operate with high position accuracy that allows continuous treatment across a treatment area. A treatment area may be a skin area that contains multiple treatment sites, e.g., a 3 cm by 3 cm treatment area containing nine 1 cm2 treatment sites. The x/y-actuator may facilitate movement of the hollow needle(s) of the apparatus from one treatment site to the adjacent treatment site within the treatment area. The x/y-actuator may also facilitate movement of the hollow needle(s) of the apparatus within each treatment site. The x/y-actuator may operate with high position accuracy that avoid gaps between adjacent treatment sites in the treatment area and/or avoid overlaps between adjacent treatment sites in the treatment area.
The x/y-actuator may also operate at a relatively high speed to minimize treatment time. In some embodiments, one actuation cycle in the x- and/or y-direction takes from about 50 milliseconds to about 250 milliseconds (e.g., 50, 75, 100, 125, 150, 175, 200, 225, and 250 milliseconds). In some embodiments, one actuation cycle in the x- and/or y-direction takes about 120 milliseconds to about 160 milliseconds (e.g., 120, 125, 130, 135, 140, 145, 150, 155, and 160 milliseconds (e.g., about 140 milliseconds)). In some embodiments, one actuation cycle in the x- and/or y-direction takes about 120 milliseconds to about 160 milliseconds (e.g., 120, 125, 130, 135, 140, 145, 150, 155, and 160 milliseconds (e.g., about 140 milliseconds)) to travel about 0.6 mm to about 1 mm (e.g., 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, and 1 mm). In some embodiments, one actuation cycle in the x- and/or y-direction takes about 140 milliseconds to travel about 0.833 mm.
In some embodiments, the x/y-actuator may be capable of operating with a force of about 0.5 N to about 20 N (e.g., 0.5 N to 0.75 N, 0.5 N to 1 N, 0.5 N to 1.25 N, 0.5 N to 1.5 N, 0.5 N to 2 N, 0.5 N to 5 N, 0.5 N to 10 N, 0.5 N to 12 N, 0.5 N to 15 N, 0.5 N to 20 N, 0.75 N to 1 N, 0.75 N to 1.25 N, 0.75 N to 1.5 N, 0.75 N to 2 N, 0.75 N to 5 N, 0.75 N to 10 N, 0.75 N to 12 N, 0.75 N to 15 N, 0.75 N to 20 N, 1 N to 1.25 N, 1 N to 1.5 N, 1 N to 2 N, 1 N to 5 N, 1 N to 10 N, 1 N to 12 N, 1 N to 15 N, 1 N to 20 N, 1.25 N to 1.5 N, 1.25 N to 2 N, 1.25 N to 5 N, 1.25 N to 10 N, 1.25 N to 12 N, 1.25 N to 15 N, 1.25 N to 20 N, 1.5 N to 2 N, 1.5 N to 5 N, 1.5 N to 10 N, 1.5 N to 12 N, 1.5 N to 15 N, 1.5 N to 20 N, 2 N to 5 N, 2 N to 10 N, 2 N to 12 N, 2 N to 15 N, 2 N to 20 N, 5 N to 10 N, 5 N to 12 N, 5 N to 15 N, 5 N to 20 N, 10 N to 12 N, 10 N to 15 N, 10 N to 20 N, 12 N to 15 N, 12 N to 20 N, and 15 N to 20 N) per hollow needle can be applied to translate the needle across the skin. In some embodiments, a force of about 5 N to 15 N (e.g., 10 N) per hollow needle can be applied to translate the needle across the skin. The x/y-actuator may also be capable of operating at a low temperature (e.g., less than about 43° C., such as less than about 43, 42, 41, 40, 39, 38, 37, 36, or 35° C.) in order to avoid raising the apparatus temperature to a level that could cause patient discomfort. Actuator types having these characteristics include voice coil (VC) actuators, pneumatic actuators, electromagnetic actuators, motors with cams, piezoelectric actuators, and motors with lead screws (e.g., stepper motors). In some embodiments, the x/y-actuator is a stepper motor with a lead screw.
In any of the apparatuses, one or more components of the apparatus may be selected or designed to secure the one or more hollow needles and/or prevent or minimize angular movement (e.g., wobbling) of the hollow needle(s). In some embodiments, the x-, y-, and/or z-actuator may be capable of operating without causing any significant angular movement (e.g., wobbling) of the hollow needle(s). In particular embodiments, the z-actuator may be capable of inserting and withdrawing the hollow needle(s) in a linear fashion without any significant angular movement (e.g., wobbling) of the hollow needle(s). The hollow needle(s) may be secured to the needle assembly so as to minimize or reduce angular movement of the needle(s) during insertion to less than 5 degrees, e.g., less than 4, 3, or 2 degrees. An angular movement of the needle(s) during insertion of ˜1-1.5 degrees is within nominal tolerances, whereas an angular movement of the needle(s) during insertion of ˜4-5 degrees or more is to be avoided, if possible. For example, components that join hollow needle(s) to other components of the needle assembly may be designed with low mechanical tolerances to firmly secure the hollow needle(s). This may reduce the prevalence of or lower the risk of destabilization and/or reduction in the structural integrity of hollow needle(s) that may result from repeated use. For example, firmly securing the needle(s) may prevent and/or minimize dulling, bending, and curling of needle tip(s) that could reduce the effectiveness of the needle(s). Firmly securing the needle(s) may also reduce the risk of over-striking (e.g., striking a hole produced by a needle more than once).
An actuation unit having an x-, y-, and/or z-actuator may be integrated into the apparatus or may be detachably connected to the needle assembly of the apparatus (e.g., needle assembly 10 show in
In some embodiments, an actuation unit (e.g., actuation unit 151) and a needle assembly of the invention (needle assembly 10 shown in
The z-, x-, and y-actuators may be activated independently or together by one or more buttons, keys, toggles, switches, screws, dials, cursors, spin-wheels, or other components. In some embodiments, each of the z-, x-, and y-actuators can be separately controlled (e.g., using separate activation components, such as a button, or by using separate controls in a user interface).
The apparatus may further include a translation mechanism to drive the entire apparatus across the skin (e.g., x- and y-translation). A translation mechanism may include, e.g., driving wheels or rods. A translation mechanism may permit automatic or manual translation of the apparatus across the skin. Translating components (e.g., wheels) may be disposed on the apparatus or be disposed external to the apparatus. The translating mechanism may be activated by an activator, such as a button, key, toggle, switch, screw, cursor, dial, spin-wheel, or other component, and/or may be digitally controlled by a user interface.
The apparatus may also include a position detection mechanism, such as an optical tracking mechanism. A position detection mechanism (e.g., a camera, infrared sensor, photodiode, and LED and detector) may assist in tracking movement of the apparatus in relation to a patient or a treatment area. The optical tracking mechanism may also facilitate placement of the hollow needle on the skin surface in the instance of manual translation of the apparatus across the skin. Control electronics for a position detection mechanism may be disposed within the apparatus or external to the apparatus, e.g., in a base unit or separate computer. For example, the position detection mechanism may monitor the distance between the previous needle insertion and the current apparatus position and send a signal to the control electronics to actuate the skin penetration mechanism when the apparatus has reached the desired position (e.g., a position a defined distance from the position where the needles were last inserted). Desired distances and/or positions may be controlled at user interface.
The apparatus may also include a guide or template to facilitate the positioning of the hollow needle of the apparatus. A guide or template may contain one or more holes or openings that provide a pre-set array pattern (described further herein) for the hollow needle of an apparatus of the invention to follow. The guide or template may be used alone or in combination with the position detection mechanism. The hollow needle may be translated by the x- and/or y-actuators to move across the guide or template and follow the array pattern set by the guide or the template to remove skin tissue portions at the holes or openings in the guide or template.
Locking or Connecting Mechanisms
A locking or connecting mechanism may be used to couple components and units described herein, e.g., coupling of an actuation unit (e.g., actuation unit 151) to a support base of the needle assembly (e.g., support base 11) and coupling of an actuation unit (e.g., actuation unit 151) to a cover of the apparatus (e.g., cover 161). A locking or connecting mechanism may be established by a vacuum connection, a magnetic connection, and/or a mechanical connection (e.g., using quick-connect clasps). A locking or connecting mechanism used to couple adjacent components or units described herein may be detachably engaged for easy and quick connection and disconnection. A locking or connecting mechanism may include one or more of adhesive, magnetic, electrical, and/or mechanical components (e.g., one or more gaskets, o-rings, septa, springs, clasps, and other engagement members).
Various locking or connecting mechanisms are shown in
To use a locking or connecting mechanism shown in any one of
Array Patterns
The one or more hollow needles of the apparatus may be configured to form an array pattern in the skin upon removal of the portions of the skin tissue. The array pattern may include holes in one or more rows or in a semi-random spatial distribution. The size and geometry of an array pattern may be generated based on the area of skin and condition being treated. For example, a small array pattern may be generated for treatment of the peri-oral area, while a large array pattern may be suitable for treatment of the abdomen. In some embodiments, an array pattern may be generated using different numbers and/or arrangements of a plurality of hollow needles. In some embodiments, an array pattern may be generated using one hollow needle, which can undergo multiple actuation cycles and be translated across the surface of the skin region by the x-actuator and/or y-actuator to generate the array pattern. In some embodiments, an array pattern may be generated using a plurality of hollow needles (e.g., an array of hollow needles), which can undergo one or more actuation cycles to generate the array pattern. The number of actuation cycles needed to generate an array pattern of holes in the skin tissue is determined by the size of the array pattern, the gauge or inner diameter of the hollow needle, the number of hollow needles, and the amount of skin tissue to be removed, e.g., the areal fraction of skin tissue removed. An “areal fraction” of tissue removed refers to the fraction of the skin tissue surface covered by the holes generated by the hollow needle(s) of the apparatus. In other words, an areal fraction of tissue removed refers to the ratio of the area covered by the total amount of cored tissue portions to the total skin treatment area. In one embodiment, one or more hollow needles may be configured to remove an areal fraction of about 0.01 to about 0.65 (e.g., 0.01, 0.02, 0.03, 0.04, 0.05, 0.10, 0.15, 0.20, 0.25, 0.30, 0.35, 0.40, 0.45, 0.50, 0.55, 0.60, and 0.65) of tissue within a treatment area. In another embodiment, one or more hollow needles may be configured to remove an areal fraction of less than about 0.1, such as about 0.01 to about 0.05 (e.g., 0.01, 0.015, 0.02, 0.025, 0.03, 0.035, 0.04, 0.045, and 0.05) of tissue within a treatment area. In another embodiment, one or more hollow needles may be configured to remove an areal fraction of about 0.02 to about 0.03 (e.g., 0.02, 0.021, 0.022, 0.023, 0.024, 0.025, 0.026, 0.027, 0.028, 0.029, and 0.03, e.g., 0.025) of tissue within a treatment area. In some embodiments, an areal fraction of about 0.01 to about 0.65 (e.g., 0.01, 0.02, 0.03, 0.04, 0.05, 0.10, 0.15, 0.20, 0.25, 0.30, 0.35, 0.40, 0.45, 0.50, 0.55, 0.60, and 0.65) of tissue may be removed within a treatment area for wrinkle reduction. In some embodiments, an areal fraction of about 0.02 to about 0.03 (e.g., 0.02, 0.021, 0.022, 0.023, 0.024, 0.025, 0.026, 0.027, 0.028, 0.029, and 0.03, e.g., 0.025) of tissue may be removed within a treatment area for wrinkle reduction. Table 3 below shows the number of actuation cycles required for the treatment of different body areas using a 24 gauge hollow needle.
The apparatus may be configured for detachable attachment to one or more hollow needles having the same or different configurations. The apparatus may have as few as 1 or as many as hundreds of hollow needles. In some embodiments, 1-100 hollow needles may be present (e.g., 1-10, 1-20, 1-30, 1-40, 1-50, 1-60, 1-70, 1-80, 1-90, 1-100, 3-10, 3-20, 3-30, 3-40, 3-50, 3-60, 3-70, 3-80, 3-90, 3-100, 5-10, 5-20, 5-30, 5-40, 5-50, 5-60, 5-70, 5-80, 5-90, 5-100, 10-20, 10-40, 10-60, 10-80, 10-100, 20-40, 20-60, 20-80, 20-100, 40-60, 40-80, 40-100, 60-80, 60-100, or 80-100 hollow needles). The use of an array of a plurality of hollow needles to generate an array pattern may facilitate skin treatment over larger areas and in less time.
The minimum distance between two hollow needles in an array of hollow needles may be between about 0.1 mm to about 50 mm (e.g., from 0.1 mm to 0.2 mm, 0.1 mm to 0.5 mm, 0.1 mm to 1 mm, 0.1 mm to 2 mm, 0.1 mm to 5 mm, 0.1 mm to 10 mm, 0.1 mm to 15 mm, 0.1 mm to 20 mm, 0.1 mm to 30 mm, 0.1 mm to 40 mm, 0.1 mm to 50 mm, 0.2 mm to 0.5 mm, 0.2 mm to 1 mm, 0.2 mm to 2 mm, 0.2 mm to 5 mm, 0.2 mm to 10 mm, 0.2 mm to 15 mm, 0.2 mm to 20 mm, 0.2 mm to 30 mm, 0.2 mm to 40 mm, 0.2 mm to 50 mm, 0.5 mm to 1 mm, 0.5 mm to 2 mm, 0.5 mm to 5 mm, 0.5 mm to 10 mm, 0.5 mm to 15 mm, 0.5 mm to 20 mm, 0.5 mm to 30 mm, 0.5 mm to 40 mm, 0.5 mm to 50 mm, 1 mm to 2 mm, 1 mm to 5 mm, 1 mm to 10 mm, 1 mm to 15 mm, 1 mm to 20 mm, 1 mm to 30 mm, 1 mm to 40 mm, 1 mm to 50 mm, 2 mm to 5 mm, 2 mm to 10 mm, 2 mm to 15 mm, 2 mm to 20 mm, 2 mm to 30 mm, 2 mm to 40 mm, 2 mm to 50 mm, 5 mm to 10 mm, 5 mm to 15 mm, 5 mm to 20 mm, 5 mm to 30 mm, 5 mm to 40 mm, 5 mm to 50 mm, 10 mm to 15 mm, 10 mm to 20 mm, 10 mm to 30 mm, 10 mm to 40 mm, 10 mm to 50 mm, 15 mm to 20 mm, 15 mm to 30 mm, 15 mm to 40 mm, 15 mm to 50 mm, 20 mm to 30 mm, 20 mm to 40 mm, 20 mm to 50 mm, 30 mm to 40 mm, 30 mm to 50 mm, and 40 mm to 50 mm). In some embodiments, the distance between two hollow needles in an array of hollow needles is less than about 15 mm. The minimum distance may correspond to the minimal size of an array pattern, while the maximum distance may correspond to the maximum size of an array pattern.
Array patterns of different sizes and geometries may be generated based on the area of treatment and the skin condition being treated. Array patterns may also be generated for compatibility with actuation mechanisms and control electronics of a given apparatus. Alternatively, actuation mechanisms and control electronics of an apparatus may be selected for compatibility with a desired array pattern size and/or geometry. For example, a long, linear array pattern may be generated using a translating mechanism with driving wheels, while a large, rectangular array may be generated using an x- and/or y-actuator to drive the hollow needle(s) across the skin.
In any of the apparatuses, one or more hollow needles may be configured to provide from about 10 to about 10000 cored tissue portions or more per cm2 area (e.g., 10 to 50, 10 to 100, 10 to 200, 10 to 300, 10 to 400, 10 to 500, 10 to 600, 10 to 700, 10 to 800, 10 to 900, 10 to 1000, 10 to 2000, 10 to 4000, 10 to 6000, 10 to 8000, 10 to 10000, 50 to 100, 50 to 200, 50 to 300, 50 to 400, 50 to 500, 50 to 600, 50 to 700, 50 to 800, 50 to 900, 50 to 1000, 50 to 2000, 50 to 4000, 510 to 6000, 50 to 8000, 50 to 10000, 100 to 200, 100 to 300, 100 to 400, 100 to 500, 100 to 600, 100 to 700, 100 to 800, 100 to 900, 100 to 1000, 100 to 2000, 100 to 4000, 100 to 6000, 100 to 8000, 100 to 10000, 200 to 300, 200 to 400, 200 to 500, 200 to 600, 200 to 700, 200 to 800, 200 to 900, 200 to 1000, 200 to 2000, 200 to 4000, 200 to 6000, 200 to 8000, 200 to 10000, 300 to 400, 300 to 500, 300 to 600, 300 to 700, 300 to 800, 300 to 900, 300 to 1000, 300 to 2000, 300 to 4000, 300 to 6000, 300 to 8000, 300 to 10000, 400 to 500, 400 to 600, 400 to 700, 400 to 800, 400 to 900, 400 to 1000, 400 to 2000, 400 to 4000, 400 to 6000, 400 to 8000, 400 to 10000, 500 to 600, 500 to 700, 500 to 800, 500 to 900, 500 to 1000, 500 to 2000, 500 to 4000, 500 to 6000, 500 to 8000, 500 to 10000, 600 to 700, 600 to 800, 600 to 900, 600 to 1000, 600 to 2000, 600 to 4000, 600 to 6000, 600 to 8000, 600 to 10000, 700 to 800, 700 to 900, 700 to 1000, 700 to 2000, 700 to 4000, 700 to 6000, 700 to 8000, 700 to 10000, 800 to 900, 800 to 1000, 800 to 2000, 800 to 4000, 800 to 6000, 800 to 8000, 800 to 10000, 900 to 1000, 900 to 2000, 900 to 4000, 900 to 6000, 900 to 8000, 900 to 10000, 1000 to 2000, 1000 to 4000, 1000 to 6000, 1000 to 8000, 1000 to 10000, 2000 to 4000, 2000 to 6000, 2000 to 8000, 2000 to 10000, 4000 to 6000, 4000 to 8000, 4000 to 10000, 6000 to 8000, 6000 to 10000, and 8000 to 10000 tissue portions per cm2 area) of the skin region to which the apparatus is applied (e.g., the treatment area).
Base Unit and User Interface
An apparatus of the invention may be in communication with a base unit, which may include, e.g., a user interface, a power supply, control electronics, mechanisms to drive operation of the apparatus, and other components. The base unit may feature a computer, which may be programmed to operate and/or control any or all aspects of an apparatus of the invention.
A user interface in the base unit may include buttons, keys, switches, toggles, spin-wheels, screens, touch screens, keyboards, cursors, dials, indicators, displays, and/or other components. The user interface may be configured to indicate proper couplings and attachments of the support base (e.g., support base 11), the z-actuator (e.g., a voice coil; z-actuator 12), the tissue removal tool (e.g., a piston) (e.g., tissue removal tool 13), the hollow needle(s) (e.g., hollow needle 14), the aspiration tube (e.g., aspiration tube 15), the trap (e.g., trap 16), the pressure generating source (e.g., a vacuum pump (e.g., pressure generating source 17), and/or scaffold 18 to form the needle assembly (e.g., needle assembly 10), charged and/or powered status of the apparatus, the mode and/or position of hollow needle(s), the application of low or high pressure, actuation of apparatus components, and/or other useful indicia. The user interface may be configured to provide information about the number and kind of hollow needle(s) of the apparatus, the treatment area, the treatment coverage (e.g., areal fraction of skin surface area removed), the arrangement of the hollow needle(s), the potential depth of penetration by the hollow needle(s), the mechanism or mode of operation, use count of the hollow needle(s), and other useful information. The user interface may allow adjustment of parameters and/or operation mode, application of high or low pressure, and/or activation of penetration into the skin by the hollow needle(s). The user interface may also be configured to transmit and/or receive information from another unit. For example, user actions at a user interface on the apparatus may be reflected by a user interface of the base unit, or vice versa.
The base unit may include buttons, keys, switches, toggles, spin-wheels, and/or other activation mechanisms to allow adjustment of parameters and/or operation mode, application of high or low pressure, penetration into the skin by the hollow needle(s), and/or powering on or off of the base unit and/or pressure generating source. These components may be integrated into the user interface of the base unit.
The base unit may further include electronics to control operation of the apparatus, pressure generating source, and/or other components couple to the apparatus. For example, the base unit may include one or more microcontrollers, programmable logic, discrete elements, and/or other components. The base unit may further have one or more power supplies. Power supplies may include batteries, alternators, generators, and/or other components. The base unit may be configured to allow conversion of main power to DC for system operation, for example. In some embodiments, the base unit has a battery charging station for use with a battery-powered apparatus.
The base unit may include a user interface that indicates, e.g., that the hollow needle is properly installed in the needle assembly, that the needle assembly is properly coupled to the actuation unit, that the apparatus is charged or otherwise powered (e.g., the amount of battery life remaining), that the hollow needle is in an extended or retracted position, that a pressure generating source is coupled to the apparatus, the fill level of a trap for collecting cored tissue portions, and/or other useful information. User interface may include information about the apparatus, such as the number of hollow needle(s) of the apparatus, the arrangement of the hollow needle(s), the potential depth of tissue penetration by the hollow needle(s), the mechanism or mode of operation, and/or other useful information. User interface may include buttons, keys, switches, toggles, spin-wheels, LED displays, and/or touch screens that allow the user to observe and change various parameters or configurations during operation of the apparatus, to activate the pressure generating source, and/or to initiate penetration into the skin by the hollow needle(s). User interface may also be configured to transmit and/or receive information from another unit, such as a computer.
Additional Components
Additional components, such as a camera and/or viewing station, may be coupled to an apparatus of the invention. A camera may be used to image a treatment area before, during, or after treatment. In some embodiments, a camera may be disposed in or on the apparatus. The camera may transmit signal to a viewing station, such as a computer, that may be disposed in the line of sight of the device operator. The image or images transmitted by the camera to the viewing station (e.g., a computer) may be processed by a visualization software. The visualization software may be capable of calculating a hole density within a treatment area (e.g., the number of holes generated per unit area). The image or images transmitted by the camera to the viewing station (e.g., a computer) may assist the operator in treating the skin. A fluid system may be coupled to an apparatus of the invention to facilitate cleaning of the skin, e.g., with saline or a sterilizing solution.
The hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods of the invention may be used in combination with a medical record system, e.g., a Computerized Patient Record System (CPRS), and/or a graphic user interface (GUI). The graphic user interface may provide information regarding various parameters of the treatment site of the patient, such as the size of the array pattern and the number of holes to be selected for in each treatment site.
Materials
The hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods of the invention can include any useful materials. For example, the needle assembly may include and/or be formed from any useful polymer or plastic. Such materials may include alginate, benzyl hyaluronate, carboxymethylcellulose, cellulose acetate, chitosan, collagen, dextran, epoxy, gelatin, hyaluronic acid, hydrocolloids, nylon (e.g., nylon 6 or PA6), pectin, poly (3-hydroxyl butyrate-co-poly (3-hydroxyl valerate), polyalkanes, polyalkene, polyalkynes, polyacrylate (PA), polyacrylonitrile (PAN), polybenzimidazole (PBI), polycarbonate (PC), polycaprolactone (PCL), polyester (PE), polyethylene glycol (PEG), polyethylene oxide (PEO), PEO/polycarbonate/polyurethane (PEO/PC/PU), poly(ethylene-co-vinyl acetate) (PEVA), PEVA/polylactic acid (PEVA/PLA), polyethylene, polypropylene, poly (ethylene terephthalate) (PET), PET/poly (ethylene naphthalate) (PET/PEN) polyglactin, polyglycolic acid (PGA), polyglycolic acid/polylactic acid (PGA/PLA), polyimide (PI), polylactic acid (PLA), poly-L-lactide (PLLA), PLLA/PC/polyvinylcarbazole (PLLA/PC/PVCB), poly (β-malic acid)-copolymers (PMLA), polymethacrylate (PMA), poly (methyl methacrylate) (PMMA), polystyrene (PS), polyurethane (PU), poly (vinyl alcohol) (PVA), polyvinylcarbazole (PVCB), polyvinyl chloride (PVC), polyvinylidenedifluoride (PVDF), polyvinylpyrrolidone (PVP), silicone, rayon, polytetrafluoroethylene (PTFE), polyether ether ketone (PEEK), or combinations thereof. Polymers and/or plastics of the invention may be composite materials in which additives to the polymers and/or plastics, such as ceramics or particles, alter the mechanical properties.
Elements of the invention (e.g., all or a portion of the apparatus, such as all or a portion of the needle assembly, the actuation unit, or other components) may also include and/or be formed from any useful metal or metal alloy. For example, in some embodiments, a hollow needle may be a metallic needle. Metals and alloys featured in the invention include stainless steel; titanium; a nickel-titanium (NiTi) alloy; a nickel-titanium-niobium (NiTiNb) alloy; a nickel-iron-gallium (NiFeGa) alloy; a nickel-manganese-gallium (NiMnGa) alloy; a copper-aluminum-nickel (CuAlNi) allow; a copper-zinc (CuZn) alloy; a copper-tin (CuSn) alloy; a copper-zinc-aluminum (CuZnAl) alloy; a copper-zinc-silicon (CuZnSi) alloy; a copper-zinc-tin (CuZnSn) alloy; a copper-manganese alloy; a gold-cadmium (AuCd) alloy; a silver-cadmium (AgCd) alloy; an iron-platinum (FePt) alloy; an iron-manganese-silicon (FeMnSi) alloy; a cobalt-nickel-aluminum (CoNiAl) alloy; a cobalt-nickel-gallium (CoNiGa) alloy; or a titanium-palladium (TiPd) alloy. Elements of the invention may also include and/or be formed from glass. For example, an apparatus of the invention may include one or more glass hollow needles.
The hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods of the invention may contain one or more adhesives. An adhesive may be located on a surface, between elements, or otherwise adhered to an element of the invention. Useful adhesives include a biocompatible matrix (e.g., those including at least one of collagen (e.g., a collagen sponge), low melting agarose (LMA), polylactic acid (PLA), and/or hyaluronic acid (e.g., hyaluranon); a photosensitizer (e.g., Rose Bengal, riboflavin-5-phosphate (R-5-P), methylene blue (MB), N-hydroxypyridine-2-(1H)-thione (N-HTP), a porphyrin, or a chlorin, as well as precursors thereof); a photochemical agent (e.g., 1,8 naphthalimide); a synthetic glue (e.g., a cyanoacrylate adhesive, a polyethylene glycol adhesive, or a gelatin-resorcinol-formaldehyde adhesive); a biologic sealant (e.g., a mixture of riboflavin-5-phosphate and fibrinogen, a fibrin-based sealant, an albumin-based sealant, or a starch-based sealant); or a hook or loop and eye system (e.g., as used for Velcro®). In some embodiments, the adhesive is biodegradable.
The adhesive may be a pressure-sensitive adhesive (PSA). The properties of pressure sensitive adhesives are governed by three parameters: tack (initial adhesion), peel strength (adhesion), and shear strength (cohesion). Pressure-sensitive adhesives can be synthesized in several ways, including solvent-borne, water-borne, and hot-melt methods. Tack is the initial adhesion under slight pressure and short dwell time and depends on the adhesive's ability to wet the contact surface. Peel strength is the force required to remove the PSA from the contact surface. The peel adhesion depends on many factors, including the tack, bonding history (e.g. force, dwell time), and adhesive composition. Shear strength is a measure of the adhesive's resistance to continuous stress. The shear strength is influenced by several parameters, including internal adhesion, cross-linking, and viscoelastic properties of the adhesive. Permanent adhesives are generally resistant to debonding and possess very high peel and shear strength. Pressure-sensitive adhesives may include natural rubber, synthetic rubber (e.g., styrene-butadiene and styrene-ethylene copolymers), polyvinyl ether, polyurethane, acrylic, silicones, and ethylene-vinyl acetate copolymers. A copolymer's adhesive properties can be altered by varying the composition (via monomer components) changing the glass transition temperature (Tg) or degree of cross-linking. In general, a copolymer with a lower Tg is less rigid and a copolymer with a higher Tg is more rigid. The tack of PSAs can be altered by the addition of components to alter the viscosity or mechanical properties. Pressure sensitive adhesives are further described in Czech et al., “Pressure-Sensitive Adhesives for Medical Applications,” in Wide Spectra of Quality Control, Dr. Isin Akyar (Ed., published by InTech), Chapter 17 (2011), which is hereby incorporated by reference in its entirety.
An apparatus, method, or kit may contain or be configured to deliver one or more useful therapeutic agents. For example, the hollow needles of the apparatus of the invention may be configured to administer one or more therapeutic agents to the skin. The hollow needles of the apparatus of the invention may be capable of creating direct channels or holes to the local blood supply and local perfusion by removing cored tissue portions. The direct channels or holes may be used to deliver useful therapeutic agents. Depending on the size (e.g., diameter and/or active length) of the hollow needles, holes having different diameters and/or penetration depths may be created. For example, hollow needles having a large diameter (e.g., 18 gauge) and/or a long active length may be used to create large and deep holes that may be used as delivery channels to deliver a large volume dose of therapeutic agents. In some embodiments, the holes may be plugged. In some embodiments, the holes may be covered with a dressing (e.g., a compressive or occlusive dressing) and/or a closure (e.g., bandage, hemostats, sutures, or adhesives) to prevent the delivered therapeutic agents from leaking out of the skin and/or to maintain moisture of the treated skin area. Delivery of useful therapeutic agents through the holes created by the hollow needles of the apparatus may provide precise control of dosing of the therapeutic agents.
Examples of useful therapeutic agents include one or more growth factors (e.g., vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), transforming growth factor beta (TGF-β), fibroblast growth factor (FGF), epidermal growth factor (EGF), and keratinocyte growth factor); one or more stem cells (e.g., adipose tissue-derived stem cells and/or bone marrow-derived mesenchymal stem cells); one or more skin whitening agents (e.g., hydroquinone); one or more vitamin A derivatives (e.g., tretinoin), one or more analgesics (e.g., paracetamol/acetaminophen, aspirin, a non-steroidal antiinflammatory drug, as described herein, a cyclooxygenase-2-specific inhibitor, as described herein, dextropropoxyphene, co-codamol, an opioid (e.g., morphine, codeine, oxycodone, hydrocodone, dihydromorphine, pethidine, buprenorphine, tramadol, or methadone), fentanyl, procaine, lidocaine, tetracaine, dibucaine, benzocaine, p-butylaminobenzoic acid 2-(diethylamino) ethyl ester HCl, mepivacaine, piperocaine, dyclonine, or venlafaxine); one or more antibiotics (e.g., cephalosporin, bactitracin, polymyxin B sulfate, neomycin, bismuth tribromophenate, or polysporin); one or more antifungals (e.g., nystatin); one or more antiinflammatory agents (e.g., a non-steroidal antiinflammatory drug (NSAID, e.g., ibuprofen, ketoprofen, flurbiprofen, piroxicam, indomethacin, diclofenac, sulindac, naproxen, aspirin, ketorolac, or tacrolimus), a cyclooxygenase-2-specific inhibitor (COX-2 inhibitor, e.g., rofecoxib (Vioxx®), etoricoxib, and celecoxib (Celebrex®)), a glucocorticoid agent, a specific cytokine directed at T lymphocyte function), a steroid (e.g., a corticosteroid, such as a glucocorticoid (e.g., aldosterone, beclometasone, betamethasone, cortisone, deoxycorticosterone acetate, dexamethasone, fludrocortisone acetate, hydrocortisone, methylprednisolone, prednisone, prednisolone, or triamcinolone) or a mineralocorticoid agent (e.g., aldosterone, corticosterone, or deoxycorticosterone)), or an immune selective antiinflammatory derivative (e.g., phenylalanine-glutamine-glycine (FEG) and its D-isomeric form (feG))); one or more antimicrobials (e.g., chlorhexidine gluconate, iodine (e.g., tincture of iodine, povidone-iodine, or Lugol's iodine), or silver, such as silver nitrate (e.g., as a 0.5% solution), silver sulfadiazine (e.g., as a cream), or Ag+ in one or more useful carriers (e.g., an alginate, such as Acticoat® including nanocrystalline silver coating in high density polyethylene, available from Smith & Nephew, London, U.K., or Silvercel® including a mixture of alginate, carboxymethylcellulose, and silver coated nylon fibers, available from Systagenix, Gatwick, U.K.; a foam (e.g., Contreet® Foam including a soft hydrophilic polyurethane foam and silver, available from Coloplast A/S, Humlebæk, Denmark); a hydrocolloid (e.g., Aquacel® Ag including ionic silver and a hydrocolloid, available from Conva Tec Inc., Skillman, N.J.); or a hydrogel (e.g., Silvasorb® including ionic silver, available from Medline Industries Inc., Mansfield, Mass.)); one or more antiseptics (e.g., an alcohol, such as ethanol (e.g., 60-90%), 1-propanol (e.g., 60-70%), as well as mixtures of 2-propanol/isopropanol; boric acid; calcium hypochlorite; hydrogen peroxide; manuka honey and/or methylglyoxal; a phenol (carbolic acid) compound, e.g., sodium 3,5-dibromo-4-hydroxybenzene sulfonate, trichlorophenylmethyl iodosalicyl, or triclosan; a polyhexanide compound, e.g., polyhexamethylene biguanide (PHMB); a quaternary ammonium compound, such as benzalkonium chloride (BAC), benzethonium chloride (BZT), cetyl trimethylammonium bromide (CTMB), cetylpyridinium chloride (CPC), chlorhexidine (e.g., chlorhexidine gluconate), or octenidine (e.g., octenidine dihydrochloride); sodium bicarbonate; sodium chloride; sodium hypochlorite (e.g., optionally in combination with boric acid in Dakin's solution); or a triarylmethane dye (e.g., Brilliant Green)); one or more antiproliferative agents (e.g., sirolimus, tacrolimus, zotarolimus, biolimus, or paclitaxel); one or more emollients; one or more hemostatic agents (e.g., collagen, such as microfibrillar collagen, chitosan, calcium-loaded zeolite, cellulose, anhydrous aluminum sulfate, silver nitrate, potassium alum, titanium oxide, fibrinogen, epinephrine, calcium alginate, poly-N-acetyl glucosamine, thrombin, coagulation factor(s) (e.g., II, V, VII, VIII, IX, X, XI, XIII, or Von Willebrand factor, as well as activated forms thereof), a procoagulant (e.g., propyl gallate), an anti-fibrinolytic agent (e.g., epsilon aminocaproic acid or tranexamic acid), and the like); one or more procoagulative agents (e.g., any hemostatic agent described herein, desmopressin, coagulation factor(s) (e.g., II, V, VII, VIII, IX, X, XI, XIII, or Von Willebrand factor, as well as activated forms thereof), procoagulants (e.g., propyl gallate), antifibrinolytics (e.g., epsilon aminocaproic acid), and the like); one or more anticoagulative agents (e.g., heparin or derivatives thereof, such as low molecular weight heparin, fondaparinux, or idraparinux; an anti-platelet agent, such as aspirin, dipyridamole, ticlopidine, clopidogrel, or prasugrel; a factor Xa inhibitor, such as a direct factor Xa inhibitor, e.g., apixaban or rivaroxaban; a thrombin inhibitor, such as a direct thrombin inhibitor, e.g., argatroban, bivalirudin, dabigatran, hirudin, lepirudin, or ximelagatran; or a coumarin derivative or vitamin K antagonist, such as warfarin (coumadin), acenocoumarol, atromentin, phenindione, or phenprocoumon); one or more immune modulators, including corticosteroids and non-steroidal immune modulators (e.g., NSAIDS, such as any described herein); one or more proteins; and/or one or more vitamins (e.g., vitamin A, C, and/or E). One or more of botulinum toxin, fat (e.g. autologous), hyaluronic acid, a collagen-based filler, or other filler may also be administered to the skin. Platelet rich plasma may also be administered to the skin. One or more therapeutic agents described herein may be formulated as a depot preparation. In general, depot preparations are typically longer acting than non-depot preparations. In some embodiments, depot preparations are prepared using suitable polymeric or hydrophobic materials (for example an emulsion in an acceptable oil) or ion exchange resins, or as sparingly soluble derivatives, for example, as a sparingly soluble salt.
A therapeutic agent may include anticoagulative and/or procoagulative agents. For instance, by controlling the extent of bleeding and/or clotting in treated skin regions, a skin tightening effect may be more effectively controlled. Thus, in some embodiments, the methods and devices herein include or can be used to administer one or more anticoagulative agents, one or more procoagulative agents, one or more hemostatic agents, one or more fillers, or combinations thereof. In particular embodiments, the therapeutic agent controls the extent of bleeding and/or clotting in the treated skin region, including the use one or more anticoagulative agents (e.g., to inhibit clot formation prior to skin healing or slit/hole closure) and/or one or more hemostatic or procoagulative agents.
Configurations
An apparatus of the invention may include a variety of components in different configurations. For example, an apparatus may include one or more hollow needles, a pressure generating source, a tissue removal tool (e.g., a piston), an aspiration tube, a trap for collecting waste materials (e.g., cored tissue portions), a support base, and an actuation unit (e.g., an actuation unit including an x-, y-, and/or z-actuator). One or more hollow needles, a pressure generating source, a tissue removal tool (e.g., a piston), an aspiration tube, a trap for collecting waste materials (e.g., cored tissue portions), a support base, and/or a z-actuator may be detachably connected to form a needle assembly (e.g., needle assembly 10 shown in
Treatment of a region of skin of a patient may proceed by supplying power to the apparatus, preparing the skin region for treatment (e.g., sterilizing and/or positioning the skin), placing a hollow needle (e.g., hollow needle 14) of the apparatus upon the skin in the treatment region, and activating the mechanism (e.g., z-actuator) that drives penetration of hollow needle into the skin. As the hollow needle is withdrawn from the skin, it is in communication and contact with the tissue removal tool (e.g., a piston; tissue removal tool 13), which slides into the lumen and pushes the cored tissue portion in the lumen of the hollow needle (e.g., hollow needle 14) towards the needle tip (e.g., needle tip 18) as the hollow needle continues to move upward. The operator may activate the pressure generating source (e.g., a vacuum pump; pressure generating source 17) to remove cored tissue portion from the needle tip. The activation of the pressure generating source may be automatically trigged by the hollow needle (e.g., hollow needle 14) when the hollow needle is in its uppermost position. The cored tissue portion is aspirated into the aspiration tube (e.g., aspiration tube 15) as vacuum is applied and collects at the trap (e.g., trap 16) between the aspiration tube and the pressure generating source (e.g., a vacuum pump). Application of vacuum may be ceased prior to translation of the hollow needle to an adjacent skin region for further treatment. The process may be repeated until the entire skin region of interest has been treated, at which point the hollow needle (e.g., hollow needle 14) and/or the entire needle assembly (e.g., needle assembly 10) can be detached from the apparatus via a quick-release mechanism, the hollow needle (e.g., hollow needle 14) and/or the entire needle assembly (e.g., needle assembly 10) disposed of or replaced, and the other components of the apparatus sterilized as needed. Such treatment may provide a plurality of cored tissue portions with dimensions, geometries, and other characteristics corresponding to the dimensions, geometries, and other characteristics of the hollow needle. For example, a hollow needle inserted about 2 mm into the skin may provide a tissue portion having a depth or length of about 2 mm.
In an alternative configuration, an apparatus of the invention may integrate a miniature pressure generating source (e.g., a vacuum pump) into the needle assembly of the apparatus. In this instance, the miniature pressure generating source (e.g., a vacuum pump) is in direct communication with the hollow needle (e.g., the proximal end of the hollow needle). A cored tissue portion inside the lumen of the hollow needle may be aspirated upward through the hollow needle by applying vacuum. A trap may be installed between the hollow needle and the miniature pressure generating source (e.g., a vacuum pump) to collect the cored tissue portion and prevent the cored tissue portion from entering the miniature pressure generating source (e.g., a vacuum pump). In this instance, the cored tissue portion in the lumen is directly aspirated upward through the hollow needle.
The pressure generating source (e.g., a vacuum pump) may be part of the needle assembly of the apparatus (e.g., attached to the aspiration tube (if present)) or external to the apparatus; for example, the vacuum source may be a medical or house vacuum source. Alternatively, the vacuum source may be a pump, such as a scroll, momentum transfer, rotary, diffusion, or diaphragm pump. The apparatus may further include a power supply, control electronics, and/or actuation, translation, and/or position detection mechanisms.
The apparatus may be charged by either removing the batteries from their holder, e.g., to be charged in a battery charging unit, or by placing the apparatus in an external battery charging station. The apparatus and/or base unit may also include components that allow for wireless communication therebetween.
Kits
The invention also features kits for cosmetic resurfacing of the skin tissue. In some embodiments, kits may include one or more hollow needles. The kits may also include, either alone or with the one or more hollow needles, other components of a needle assembly of the apparatus (e.g., a support base (e.g., support base 11), a z-actuator (e.g., a voice coil; z-actuator 12), a tissue removal tool (e.g., tissue removal tool (e.g., a piston) 13), an aspiration tube (e.g., aspiration tube 15), a trap (e.g., trap 16), a pressure generating source (e.g., pressure generating source (e.g., a vacuum pump) 17), and/or a scaffold (e.g., scaffold 18)), an actuation unit including an x- and y-actuators (e.g., actuation unit 151), and/or a cover (e.g., cover 161). The one or more hollow needles, the entire needle assembly, and/or components of the needle assembly in a kit may be configured to be detachably attached to the apparatus. The hollow needle(s) may be configured to be in communication with a pressure generating source (e.g., a vacuum pump). In some embodiments, kits may be packaged with the hollow needle(s) in sterile form and with instructions for applying the hollow needle(s) to the needle assembly of an apparatus of the invention and/or with instructions for applying the needle assembly to the actuation unit of the apparatus of the invention. In some embodiments, kits may be packaged with the entire needle assembly in sterile form and with instructions for applying the needle assembly to the actuation unit of an apparatus of the invention. Kits may also include one or more replacement hollow needles and/or one or more replacement components of the needle assembly. Kits may also include entire needle assemblies as replacement parts.
Kits of the invention may include additional components, such as a trap for collecting waste materials (e.g., cored tissue portions); a pressure generating source (e.g., a vacuum pump); mechanisms for actuation, translation, and position detection (e.g., one or more voice coil (VC), pneumatic, electromagnetic, and/or piezoelectric actuators; driving wheels; and/or a camera); and a base unit having a user interface. In addition, kits of the invention may include any other useful components, such as instructions on how to use the hollow needle(s), the needle assembly, the actuation unit, and/or the apparatus, one or more therapeutic agents (e.g., any described herein, such as an anticoagulative and/or procoagulative agent, and optionally in combination with a useful dispenser for applying the therapeutic agent, such as a brush, spray, film, ointment, cream, lotion, or gel), one or more wound cleansers (e.g., including any antibiotic, antimicrobial, or antiseptic, such as those described herein, in any useful form, such as a brush, spray, film, ointment, cream, lotion, or gel), one or more dressings (e.g., compressive or occlusive dressings), one or more closures (e.g., bandage, hemostats, sutures, or adhesives), one or more debriding agents, one or more adhesives (e.g., any described herein), one or more cosmetics (e.g., as described herein), and/or other suitable or useful materials.
Kits of the invention may include any of the components provided herein (e.g., hollow needle(s), a trap, a pressure generating source, a tissue removal tool (e.g., a piston), an aspiration tube, and/or a z-actuator) in any number. Kits may also have or be designed to have any of the configurations described herein.
Method for Cosmetic Skin Resurfacing
Any of the hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods of the invention may be used for cosmetic skin resurfacing of the skin tissue by removing skin tissue portions. The hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods of the invention can be applied to treat one or more skin regions. In particular embodiments, these regions are treated with one or more procedures to improve skin appearance and to rejuvenate skin. In preferred embodiments, the hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods described herein can be useful for skin tightening, e.g., reducing skin laxity (e.g., loose or sagging skin or other skin irregularities). In other embodiments, the hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods herein can be useful for removal of, e.g., pigment, hair follicles, and/or vessels in the skin, and/or for treating acne, allodynia, blemishes, ectopic dermatitis, hyperpigmentation, hyperplasia (e.g., lentigo or keratosis), loss of translucency, loss of elasticity, melasma (e.g., epidermal, dermal, or mixed subtypes), photodamage, rashes (e.g., erythematous, macular, papular, and/or bullous conditions), psoriasis, rhytides (or wrinkles, e.g., lateral canthal lines (“crow's feet”), age-related rhytides, sun-related rhytides, or heredity-related rhytides), sallow color, scar contracture (e.g., relaxation of scar tissue), scarring (e.g., due to acne, surgery, or other trauma), skin aging, skin contraction (e.g., excessive tension in the skin), skin irritation/sensitivity, striae (or stretch marks), tattoo removal, vascular lesions (e.g., angioma, erythema, hemangioma, papule, port wine stain, rosacea, reticular vein, or telangiectasia), or any other unwanted skin irregularities. The hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods described herein may also be used to penetrate skin and trigger biological responses that may contribute to new skin tissue formation and tissue resurfacing and remodeling.
Such skin treatments may be applied to any part or parts of the body, including the face (e.g., eyelid, cheeks, chin, forehead, lips, or nose), neck, chest (e.g., as in a breast lift), arms, hands, legs, abdomen, and/or back. Accordingly, the hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods of the invention can be configured to be useful for treatment of regions of the body with different sizes and geometries. For example, arrays of hollow needles of different sizes, geometries, and arrangements may be included in a kit of the invention to allow for treatment of both facial (e.g., with tips having small arrays of regular or irregular geometries) and abdominal regions (e.g., with tips having large arrays of regular geometries). In some embodiments, such arrangements and configurations can be in one or more rows or in a semi-random spatial distribution. In other embodiments, arrangements of hollow needles can include any useful shape (e.g., linear, curved, or stellate), size, geometry, depth, and/or other characteristics. Alternatively, an apparatus of the invention can include a single hollow needle and the apparatus can be used to repeatedly remove skin tissue in an array pattern forming one or more rows, random or semi-random patterns, or other patterns.
Treatment methods may involve forming a plurality of holes in the skin by contacting one or more hollow needles to the skin of a subject and removing the cored tissue portions from the skin. Penetration into the skin by the hollow needle(s) create holes and so effectively reduce tissue volume and/or improve tissue quality upon healing. For example, forming a series of cored tissue portions (e.g., removal of about 20% of the total skin area) and corresponding holes in a high laxity skin region and optionally subsequent compression of the skin region to close the holes may promote the growth of new skin (e.g., improved tissue). Healing of the tissue under a dressing (e.g., a compressive or occlusive dressing) allows for the existing tissue to span the gap introduced by the removal of cored tissue portions, thereby reducing the skin volume and area (e.g., by tightening the skin). A dressing (e.g., a compressive or occlusive dressing) may also help to maintain moisture of the treated skin area and/or to prevent delivered therapeutic agents from leaking out of the skin.
Any beneficial area or volumetric fraction of the skin region can be removed. For example, between about 1% to about 65% (e.g., an areal fraction between about 0.01 to about 0.65, such as 0.01 to 0.65, 0.01 to 0.6, 0.01 to 0.55, 0.01 to 0.5, 0.01 to 0.45, 0.01 to 0.4, 0.01 to 0.35, 0.01 to 0.3, 0.01 to 0.25, 0.01 to 0.2, 0.01 to 0.15, 0.01 to 0.1, 0.01 to 0.05, 0.03 to 0.65, 0.05 to 0.65, 0.07 to 0.65, 0.09 to 0.65, 0.1 to 0.65, 0.15 to 0.65, 0.2 to 0.65, 0.25 to 0.65, 0.3 to 0.65, 0.35 to 0.65, 0.4 to 0.65, 0.45 to 0.65, 0.5 to 0.65, 0.55 to 0.65, and 0.6 to 0.65) of tissue in the treatment area may be removed. In some embodiments, between about 1% to about 5% (e.g., an areal fraction between about 0.01 to about 0.05, such as 0.01 to 0.05, 0.01 to 0.045, 0.01 to 0.04, 0.01 to 0.035, 0.01 to 0.03, 0.01 to 0.025, 0.01 to 0.02, 0.01 to 0.015, 0.015 to 0.05, 0.02 to 0.05, 0.025 to 0.05, 0.03 to 0.05, 0.035 to 0.05, 0.04 to 0.05, and 0.045 to 0.05) of tissue in the treatment area may be removed. In some embodiments, between about 2% to about 3% (e.g., an areal fraction between about 0.02 to about 0.03, such as 0.02 to 0.03, 0.02 to 0.028, 0.02 to 0.026, 0.02 to 0.024, 0.02 to 0.022, 0.022 to 0.03, 0.024 to 0.03, 0.026 to 0.03, 0.028 to 0.03; e.g., 0.025) of tissue in the treatment area may be removed.
Tissue can be removed from the treatment region with various hole density (e.g., the number of holes per unit area) corresponding to the number and geometry of hollow needle(s) of the apparatus used and the number of applications of the hollow needle(s) to the treatment region. Different hole densities may be desirable for different regions of skin and for different conditions and may be achieved using different hollow needle(s). For example, 15 holes corresponding to the size of a 19 gauge needle and their corresponding cored tissue portions may be created in a given treatment area by actuation of a single 19 gauge needle 15 times, or by actuating an array having five 19 gauge needles three times. Spacing the same number of holes further apart will result in a lower hole density per unit area. For example, 15 holes may be created within a 0.5 mm by 0.3 mm region or within a 5 mm by 3 mm region. In particular embodiments, hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods of the invention (e.g., any described herein) are configured to provide from about 10 to about 10000 cored tissue portions per cm2 area of the skin region (e.g., as described herein). The array of holes created by removal of the skin tissue portions may be created in any beneficial pattern within the skin region. For example, a higher density and/or smaller spacing of tissue portions and corresponding holes can be ablated in the skin in the center of a pattern or in thicker portions of the skin. A pattern may be semi-random or include one or more of staggered rows and/or blocks, parallel rows and/or blocks, a circular pattern, a spiral pattern, a square or rectangular pattern, a triangular pattern, a hexagonal pattern, a radial distribution, or a combination of one or more such patterns. The pattern may arise from the use of one or more hollow needles with one or more configurations and numbers of hollow needles applied in any ordered or disordered manner. Modifications to the average length, diameter, shapes, and/or other characteristics of one or more hollow needles used to treat a skin region may also result in a specific pattern of holes in the skin. Such patterns may be optimized to promote unidirectional, non-directional, or multidirectional contraction or expansion of skin (e.g., in the x-direction, y-direction, x-direction, x-y plane, y-z plane, x-z plane, and/or xyz-plane), such as by modifying the average length, depth, diameter, density, orientation, and/or spacing between hollow needles.
Any portion of the skin can be removed. Tissue portions created by penetration into the skin with the hollow needle(s) may include epidermal tissue, dermal tissue, subcutaneous fat, and/or cells or tissue proximal to the dermal/fatty layer boundary (e.g., stem cells). In some embodiments, a tissue portion may have a length that corresponds to the depth of penetration of the skin layer. In some embodiments, the depth of penetration may be (i) into the dermal layer, (ii) through the entire dermal layer to the junction of the dermal layer and the subcutaneous fat layer, or (iii) into the subcutaneous fat layer. The total depth of the epidermal, dermal, and subcutaneous fat layers may vary based on the region and age of the body being treated. In some instances, the depth of the epidermal layer is between about 0.01 mm to 0.2 mm, and/or the depth of the dermal layer is between about 0.3 mm to 6.0 mm. In some embodiments, the total depth of the epidermal and dermal layers may be between about 0.3 mm and 6.2 mm, corresponding to a possible tissue portion having a length between about 0.3 mm and 6.2 mm (e.g., between about 0.3 mm and 0.6 mm, 0.3 mm and 0.9 mm, 0.3 mm and 1.5 mm, 0.3 mm and 2.0 mm, 0.3 mm and 2.5 mm, 0.3 mm and 3.0 mm, 0.3 mm and 3.5 mm, 0.3 mm and 4.0 mm, 0.3 mm and 4.5 mm, 0.3 mm and 5.0 mm, 0.3 mm and 5.5 mm, 0.3 mm and 6.0 mm, 0.3 mm and 6.2 mm, 0.6 mm and 0.9 mm, 0.6 mm and 1.5 mm, 0.6 mm and 2.0 mm, 0.6 mm and 2.5 mm, 0.6 mm and 3.0 mm, 0.6 mm and 3.5 mm, 0.6 mm and 4.0 mm, 0.6 mm and 4.5 mm, 0.6 mm and 5.0 mm, 0.6 mm and 5.5 mm, 0.6 mm and 6.0 mm, 0.6 mm and 6.2 mm, 0.9 mm and 1.5 mm, 0.9 mm and 2.0 mm, 0.9 mm and 2.5 mm, 0.9 mm and 3.0 mm, 0.9 mm and 3.5 mm, 0.9 mm and 4.0 mm, 0.9 mm and 4.5 mm, 0.9 mm and 5.0 mm, 0.9 mm and 5.5 mm, 0.9 mm and 6.0 mm, 0.9 mm and 6.2 mm, 1.5 mm and 2.0 mm, 1.5 mm and 2.5 mm, 1.5 mm and 3.0 mm, 1.5 mm and 3.5 mm, 1.5 mm and 4.0 mm, 1.5 mm and 4.5 mm, 1.5 mm and 5.0 mm, 1.5 mm and 5.5 mm, 1.5 mm and 6.0 mm, 1.5 mm and 6.2 mm, 2.0 mm and 2.5 mm, 2.0 mm and 3.0 mm, 2.0 mm and 3.5 mm, 2.0 mm and 4.0 mm, 2.0 mm and 4.5 mm, 2.0 mm and 5.0 mm, 2.0 mm and 5.5 mm, 2.0 and 6.0 mm, 2.0 mm and 6.2 mm, 2.5 mm and 3.0 mm, 2.5 mm and 3.5 mm, 2.5 mm and 4.0 mm, 2.5 mm and 4.5 mm, 2.5 mm and 5.0 mm, 2.5 mm and 5.5 mm, 2.5 mm and 6.0 mm, 2.5 mm and 6.2 mm, 3.0 mm and 3.5 mm, 3.0 mm and 4.0 mm, 3.0 mm and 4.5 mm, 3.0 mm and 5.0 mm, 3.0 mm and 5.5 mm, 3.0 and 6.0 mm, 3.0 mm and 6.2 mm, 3.5 mm and 4.0 mm, 3.5 mm and 4.5 mm, 3.5 mm and 5.0 mm, 3.5 mm and 5.5 mm, 3.5 and 6.0 mm, 3.5 mm and 6.2 mm, 4.0 mm and 4.5 mm, 4.0 mm and 5.0 mm, 4.0 mm and 5.5 mm, 4.0 and 6.0 mm, 4.0 mm and 6.2 mm, 4.5 mm and 5.0 mm, 4.5 mm and 5.5 mm, 4.5 and 6.0 mm, 4.5 mm and 6.2 mm, 5.0 mm and 5.5 mm, 5.0 mm and 6.0 mm, 5.0 mm and 6.2 mm, 5.5 mm and 6.0 mm, 5.5 mm and 6.2 mm, or 6.0 mm and 6.2 mm).
In some instances, it may be desirable to configure hollow needles, needle assemblies, actuation units, apparatuses, kits, and methods of the invention to provide one or more tissue portions that do not include significant amounts of subcutaneous tissue, or, in other instances, to provide tissue portions that do include significant amounts of subcutaneous tissue. Electronic and/or physical mechanisms may be used to control the depth of penetration into the skin by the hollow needle(s) and the corresponding size of a cored tissue portion and hole. For example, an apparatus may include one or more one or more spacers as described herein; one or more scroll wheels, buttons, dials, toggles, or other components to physically retract the hollow needle(s); a z-actuation mechanism (e.g., a pneumatic, electromagnetic, or piezoelectric actuator or a motor with a cam); and/or one or more sensors (e.g., force sensors, optical sensors, laser fibers, photodetectors, and/or position sensors) in communication with one or more hollow needles, actuators, valves, pressure generating sources, and/or user interfaces to detect the position of hollow needle(s) and/or the position of the apparatus relative to the treated skin portion.
An apparatus of the invention may be used to administer treatment to the skin of a subject. Treatment may be performed outside of an operating room environment, thereby minimizing the cost of treatment.
The apparatus used for treatment of the subject may be any of those described herein. For example, the apparatus may be that shown in any one of
The skin area may first be sterilized, treated with chemicals, and/or otherwise prepared for treatment. The positioning mechanism disposed in the apparatus may be applied to position the hollow needle to the area of treatment. Treatment may proceed with the driving of the needle into and out of the skin by activation of the z-actuator, driving the needle containing the cored tissue portion inside its lumen to be in contact with the tissue removal tool (e.g., a piston), removal of cored tissue portion by activation of the vacuum pump coupled to the aspiration tube and the trap, and translation of the hollow needle or the entire apparatus to an adjacent region for treatment. When sufficient tissue area has been treated, the apparatus components may be powered off, the skin surface and/or holes are cleaned and/or flushed with fluid, and optionally a compressive wound dressing applied to the skin to cause the holes to close. The trap may be disposed of, and other components of the system may be detached and sterilized.
The treatment may be rapid (e.g., less than 30 minutes), minimizing patient downtime and allowing treatment to be carried out as an outpatient procedure. Within days, a reduction in skin laxity and/or rhytides in the treatment area may be observed.
The hollow needle used in Example 1 may be replaced with a hollow needle having an edge. For example, the hollow needle used to treat skin laxity in the face may be a metallic, hollow needle with two prongs each having a bevel angle α of 30 degrees. The hollow needle may be a 24 gauge needle and may be affixed to the needle assembly of the apparatus at its proximal end (e.g., away from the needle tip). The tip of each prong of the hollow needle may be an edge (e.g., edge 52 as illustrated in
The hollow needle used in Example 1 may be replaced with a hollow needle having a flat tip (e.g., a two dimensional flat tip). For example, the hollow needle used to treat skin laxity in the face may be a metallic, hollow needle with two prongs each having a bevel angle α of 30 degrees. The hollow needle may be a 24 gauge needle and may be affixed to the needle assembly of the apparatus at its proximal end (e.g., away from the needle tip). The tip of each prong of the hollow needle may be a flat tip (e.g., flat tip 53 as illustrated in
While the invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modifications and this application is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles of the invention and including such departures from the present disclosure come within known or customary practice within the art to which the invention pertains and may be applied to the essential features hereinbefore set forth.
All publications, patents, and patent applications are herein incorporated by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference in its entirety.
Other embodiments are within the following claims.
This application is a U.S. National Phase Application under 35 U.S.C. § 371 of International Patent Application No. PCT/US2017/024752, filed on Mar. 29, 2017, which claims priority to and the benefit of U.S. provisional application No. 62/314,748, filed Mar. 29, 2016, the entire contents of each of which are hereby incorporated by reference in their entireties.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2017/024752 | 3/29/2017 | WO | 00 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2017/172920 | 10/5/2017 | WO | A |
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