Patent Grant
12171455
The present disclosure relates to methods and apparatus for removing or damaging small regions of fatty tissue, e.g., subcutaneous fat, while reducing or avoiding significant damage to the overlying tissue, e.g., the dermis and epidermis.
Procedures and devices for removing fatty tissue, e.g. for cosmetic reasons, are common and represent a significant market in the cosmetic procedures sector. Conventional fat-removal procedures and devices, e.g., liposuction, can be disruptive to surrounding tissue and often includes many risks such as excessive bleeding, etc. There are relatively few procedures for removal of small amounts of fatty tissue, e.g., subcutaneous fat, for cosmetic purposes and such procedures generally require a skilled practitioner for effective removal and can be very time-consuming and subject to complications.
Accordingly, there may be a need to provide simpler and safer method and apparatus for removal of subcutaneous fatty tissue that addresses and/or reduces the limitations described above.
The present disclosure describes exemplary embodiments of simple, inexpensive, and safe methods and devices for affecting fatty tissue, e.g., subcutaneous fat, while reducing or avoiding significant damage to the overlying tissue, such as the dermis and epidermis. Such methods and apparatus can provide removal of small portions of subcutaneous fatty tissue, which may optionally be implanted in other parts of the body or used to harvest stem cells present therein. Methods and apparatus for locally disrupting small regions of fatty tissue, which may then be resorbed by the body, are also described.
An exemplary apparatus according to the present disclosure can be provided that includes a hollow needle and at least one protrusion provided on an inner wall of the hollow needle. The hollow needle can be configured to be inserted into a biological tissue such as skin, such that the needle penetrates the upper tissue layers. The size and geometry of the needle can be configured such that softer or less resilient subsurface tissue, e.g., subcutaneous fat, can enter the hollow core of the needle when the distal end of the needle advances into the fat. The protrusion can be configured to facilitate retention of a portion of the fat when the needle is withdrawn from the tissue.
In a further exemplary embodiment of the present disclosure, a plurality of such hollow needles that include internal protrusions can be affixed to a substrate. The substrate and needles can be arranged to control and/or limit the depth of penetration of the needles into the tissue when the substrate is placed on the tissue surface. For example, the lengths of the distal ends of the needles protruding from a lower surface of the substrate can be selected to correspond to a depth within the fatty tissue below the skin surface.
In further exemplary embodiments of the present disclosure, the hollow needle can include a pivoting flap or one or more barbs provided within the lumen to facilitate detachment and removal of portions of the fat by the needle.
In yet further exemplary embodiments of the present disclosure, the hollow needle can include a cutting arrangement provided within the lumen to facilitate mechanical damage and/or disruption of portions of the fat by the needle.
In a another exemplary embodiment of the present disclosure, the exemplary apparatus can further include a vacuum source provided in communication with the proximal ends of the needles, which can facilitate separation and/or removal of portions of the fat from the surrounding tissue when the needle is inserted and withdrawn.
In a still further exemplary embodiment of the present disclosure, the exemplary apparatus can include a reciprocating arrangement affixed to the one or more needles. The reciprocating arrangement can include a motor or other actuator configured to repeatedly advance and withdraw the needles relative to the tissue. The reciprocating arrangement can be provided in a housing that facilitates manipulation of the apparatus, e.g., placement of the apparatus on the tissue being treated and/or traversing the apparatus over the tissue. The housing can optionally be configured to stretch or otherwise stabilize the tissue proximal to the needle(s) being inserted, to reduce deformation of the tissue and/or improve accuracy of the placement of the needle(s) in the tissue. The reciprocating arrangement can further include a translational controller configured to translate the needles over the tissue in at least one direction, and optionally in two orthogonal directions, to facilitate removal or harvesting of fat from larger regions of a donor tissue site without translating the entire apparatus over the tissue surface.
In yet another exemplary embodiment of the present disclosure, the exemplary apparatus can include a vibrating arrangement mechanically coupled to the one or more needles. The vibrating arrangement can facilitate improved removal and/or disruption of the fat tissue by the needles.
These and other objects, features and advantages of the present disclosure will become apparent upon reading the following detailed description of exemplary embodiments of the present disclosure, when taken in conjunction with the appended drawings and claims.
Further objects, features and advantages of the present disclosure will become apparent from the following detailed description taken in conjunction with the accompanying figures showing illustrative embodiments, results and/or features of the exemplary embodiments of the present disclosure, in which:
Throughout the drawings, the same reference numerals and characters, unless otherwise stated, are used to denote like features, elements, components, or portions of the illustrated embodiments. Moreover, while the present disclosure will now be described in detail with reference to the figures, it is done so in connection with the illustrative embodiments and is not limited by the particular embodiments illustrated in the figures and the appended claims.
Exemplary embodiments of the present disclosure can provide a method and apparatus for removing or locally damaging or disrupting soft tissue, e.g., subcutaneous fat, while reducing or avoiding significant damage to the overlying tissue, e.g., the dermis and epidermis in skin. Exemplary embodiments of the present disclosure can thereby facilitate removal, harvesting or disruption of subsurface tissue while avoiding and/or minimizing adverse effects such as scarring, bleeding, likelihood of infection, etc.
A cross-sectional view of an exemplary apparatus 100 for removing fatty tissue is shown in
The protrusion 130 can be provided along the inner surface of a shorter side of the angled or tapered end 110 of the needle 120. A handle 140 and/or other gripping arrangement can be provided at a proximal portion of the needle 120 to facilitate holding and manipulating the needle 120.
A frontal view of the exemplary apparatus 100 is shown in
For example, the protrusion 130 can block less than about 50% of the cross-sectional area of the hollow center, or optionally less than about 30% of this area. The protrusion 130 can block more than about 10% of the cross-sectional area, or more than about 20% of this area. The size and shape of the protrusion 130 can be configured to facilitate a retention of fatty tissue in the hollow core of the needle 120 as described herein.
The exemplary apparatus 100 can be inserted into a dermal tissue such that the distal end 110 penetrates at least partially into the subcutaneous fatty layer 210 beneath the dermis 220, as shown in
The diameter of the needle 120 can be selected to facilitate the insertion through the dermal layer 220 without removing a substantial amount of the dermal tissue, as well as separation and removal of the portion 230 of the fatty tissue, as described herein. For example, the needle 120 can have the size of a conventional 16 gauge needle, or between 14 gauge and 19 gauge. Such needle diameters can provide the tissue-selective penetration properties described herein when the apparatus 100 is inserted into skin. The diameter of the central lumen of the needle 120 can be, e.g., about 1 mm or about 1.25 mm. These exemplary needle sizes can be used with any of the exemplary embodiments described herein. Larger or smaller needle sizes may also be used in embodiments of the present disclosure if they exhibit the selective tissue properties described herein, e.g., if the methods and apparatus described herein are being used on tissues other than skin.
In exemplary embodiments of the present disclosure, the angled or tapered distal end 110 of the needle 120 as described herein can divert or push aside the resilient dermal tissue 220 as the needle 120 is inserted. As the needle 120 penetrates further into the fatty layer 210, the portion 230 of the softer fatty tissue can be more easily separated from the surrounding fatty layer 210, and enter the hollow core of the needle 120. The protrusion 130 can anchor the portion 230 of fatty tissue within the needle 120, and facilitate its separation and removal from the surrounding fatty layer 210 when the exemplary apparatus 100 is withdrawn from the dermal tissue. The exemplary apparatus 100 can be inserted and removed a plurality of times to remove further portions 230 of the fatty tissue.
A further exemplary apparatus 300 for removal of subcutaneous fat according to the present disclosure is shown in
A frontal view of the exemplary apparatus 300 is shown in
The protrusion distance of the needles 120 from the lower surface of the substrate 330 can also be selected based on a local depth of the subcutaneous fatty layer 210 and the depth to which the fatty tissue is to be removed. For example, the exemplary apparatus 300 can include an arrangement configured to adjust the protrusion distance of the needles 120. Such arrangement can include, e.g., a plate or the like affixed to the substrate 330 such that the needles 120 pass through the plate. The distance between the plate and the substrate 330 can be adjustable to vary the distance that the needles 120 protrude from the lower surface of the plate. Other exemplary arrangements that can facilitate the adjustment of the effective length of the needles 120 protruding from the bottom of the apparatus 300 may also be used. The location of the one or more protrusions 130 within the needles 120 can also be selected to control the size or height of the tissue samples 230 that may be retained and removed in the needles 120 when they are inserted into and withdrawn from the tissue, as described herein.
The exemplary apparatus 300 can be pressed into the dermal tissue and subsequently withdrawn, such that the needles 120 penetrate into the into the fatty layer 210 and remove portions of the tissue sample 230 of the fatty tissue from the fatty layer 210, as described herein and shown in
A still further exemplary apparatus 400 according to the present disclosure is shown in
In a further exemplary embodiment according to the present disclosure, the reciprocating arrangement 420 can further include a translational mechanism configured to translate the one or more needles 120 over the tissue surface in one or two orthogonal directions. For example, the reciprocating arrangement 420 can be configured to translate such one or more needles 120 over an area of the tissue while the exemplary apparatus 400 is held stationary with respect to the tissue surface at a donor or treatment site. In one exemplary embodiment of the present disclosure, the reciprocating arrangement 420 can be configured to translate the one or more needles 120 along a single direction to harvest fatty tissue along one or more rows. The exemplary apparatus 400 can optionally be translated over the tissue surface after such rows are formed, e.g., in a direction that is not parallel to the row, to remove or harvest fatty tissue from a larger area of the donor tissue site.
In further exemplary embodiments of the present disclosure, any of the exemplary apparatuses described herein can be configured to remove or harvest fatty tissue from a plurality of locations in any of a variety of spatial distributions, where each location can correspond to a single insertion and withdrawal of a single needle 120. For example, the fatty tissue can be removed or harvested from a plurality of locations configured as one or more rows, a regular two-dimensional pattern, a random distribution, or the like. Such exemplary patterns or spatial distributions of fat harvesting or removal sites can be generated based on, e.g., the configuration of such one or more needles 120 provided, the properties of the reciprocating arrangement 420, and/or the rate of translation of the exemplary apparatus 400 over the tissue surface.
In still further exemplary embodiments according to the present disclosure, the housing 430 can be configured to stretch skin or other tissue when the exemplary apparatus 400 is placed on the tissue to be treated. Such stretching can facilitate mechanical stabilization of the tissue, e.g., to reduce or avoid deformation of the tissue 350 while the needles 120 are inserted into and withdrawn from the tissue. Such stretching of the tissue can also reduce the effective size of the disrupted region of the upper tissue layers formed by the exemplary apparatus 400 when the tissue is allowed to relax after treatment. Alternatively, the surface of the tissue to be treated can be stretched or stabilized using other techniques prior to and/or during treatment of the region in accordance with any of the exemplary embodiments described herein.
For example, a vacuum or suction source, e.g. a pump or a reservoir containing a fluid under low-pressure, can be provided in communication with the lumen of the needle 120, e.g., via a conduit in communication with the proximal end of the needles 120, in any of the exemplary embodiments described herein. Such low pressure, e.g., pressure less than atmospheric or ambient pressure, provided in the central lumen can facilitate the removal of the portions 230 of fatty tissue when the distal ends of the needles 120 are located within the subcutaneous fat layer 210. For example, the exemplary devices described herein can be configured to provide such a vacuum when the distal ends of the needles 120 are at least partially inserted into the fatty layer 210, and such vacuum may be applied as the needles 120 are withdrawn from the fatty layer 210. The strength of the vacuum can be selected to facilitate removal of the portions 230 of the fatty tissue within the distal portions of the needles 120, without causing a significant damage to the tissue surrounding the inserted needles 120.
In another exemplary embodiment of the present disclosure, an apparatus 500 can be provided that is adapted to remove fatty tissue is shown in
A stop arrangement 530 can be provided on another location on the inside wall of the needle 120 to constrain or prevent movement of the flap beyond a certain limit in a particular direction. For example, the stop arrangement 530 can be provided on an opposite side of the interior needle wall from the pivot point 520, as shown in
The exemplary apparatus 500 can be used to remove or harvest portions of fatty tissue in a manner similar to that described with respect to the exemplary apparatus 100 and shown in
When the exemplary apparatus 500 is withdrawn from the skin, the fat portion 230 may be pulled downward slightly within the lumen, pulling or dragging the flap 510 with it towards the distal end 110 of the needle 120. For example, an edge of the flap 510 may ‘catch’ or penetrate the edge of the fat portion 230. As the flap 510 moves downward, it may partially or completely sever the fat portion 230 from the remainder of the subcutaneous fat below it, thereby retaining the fat portion 230 within the apparatus 500 as the apparatus 500 is withdrawn from the skin.
The flap 510 can be substantially round or moon shaped, e.g., such that it can block or occlude substantially the entire lumen when it is lowered against the stop arrangement 530. For example, an exemplary flap 510 is illustrated in
In a further exemplary embodiment, the flap 510 can be provided as a substantially rectangular shape or in another shape that does not fully occlude the lumen when the flap 510 is pivoted to a lowered position, e.g., resting against the stop arrangement 530, as shown in a view of an end the needle 120 in
Any of the features of the exemplary apparatus 500 can be used in conjunction with the other exemplary embodiments described herein. For example, one or more needles 120 that include a pivoting flap 510, and the stop arrangement 530 can be affixed to a substrate 330, e.g., as shown in
In a still further exemplary embodiment of the present disclosure, an apparatus 700 can be provided that includes one or more barbs 710 provided on the interior wall of the hollow needle 120. The barb 710 can be angled upward, e.g., sloping away from the distal end 110 of the needle 120, as shown in
In further exemplary embodiments of the present disclosure, an apparatus 800 can be provided that includes a cutting arrangement 810 provided in a distal portion of the lumen of the hollow needle 120, as shown in
The cutting arrangement 810 can include, for example, one or more thin wires, blades, or the like that extend across a portion of the lumen of the needle 120. End views of two exemplary cutting arrangements 810 are shown in
The exemplary apparatus 800 can be inserted into skin tissue and then withdrawn as described herein, for example, with respect to other exemplary embodiments of the present disclosure. Such exemplary insertion and withdrawal of the exemplary apparatus 800 can cause a portion of the fat layer 210 to enter the lumen of the needle 120, with the overlying dermis layer 220 remaining substantially unaffected after the apparatus 800 is fully withdrawn. The fat tissue that enters the lumen may be damaged by the cutting arrangement 810 during the insertion and withdrawal procedures. The exemplary apparatus can may be partially withdrawn from the skin and then advanced again a plurality of times before fully withdrawing it from the skin. For example, the exemplary apparatus 800 can be withdrawn until the distal end 110 is proximal to the lower portion of the dermal layer 220, and then re-advanced deeper into the fat layer 210. Such repeated cycles can create a greater degree of local damage to the fat tissue. Little or no fat may remain within the lumen when the apparatus 800 is withdrawn from the skin. However, the damaged fat cells may die and be resorbed by the body over time.
The features of the exemplary apparatus 800 can be used in conjunction with the other exemplary embodiments described herein. For example, a plurality of needles 120 that include a cutting arrangement 810 can be affixed to a substrate 330, e.g., as shown in
The exemplary apparatus 800 can include a plurality of needles 120 having different types of fat-disrupting arrangements as described herein. For example, different ones of the needles 120 may include a protrusion 130, a pivoting flap 510, or a cutting arrangement 810. In another exemplary embodiment, a plurality of needles 120 containing different types of such fat disruption arrangements 130, 510, 810 can be mechanically coupled to a reciprocating arrangement 420 as described herein. Different ones of the needles 120 in such multi-needle devices can optionally have different lengths, which can facilitate harvesting or damaging of fat at different depths within the fat layer 210.
In further exemplary embodiments of the present disclosure, a vibrating arrangement can be mechanically coupled to any exemplary apparatus described herein. Inducing vibration in the needles 120 can facilitate detachment of fat portions 230 from the surrounding tissue and/or can generate a greater mechanical damage by a cutting arrangement provided in the needle 120.
The exemplary methods and devices described herein can be used for a variety of purposes, for example, to remove small portions of the fatty tissue for cosmetic purposes, to harvest stem cells that may be present in regions of the subcutaneous fat layer to harvest fatty tissue for implantation in other portions of the body for cosmetic purposes, and/or to generate mechanical damage of fat cells to promote cell death and resorption of damaged fat by the body.
The foregoing merely illustrates the principles of the present disclosure. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachings herein. It will thus be appreciated that those skilled in the art will be able to devise numerous techniques which, although not explicitly described herein embody the principles of the present disclosure and are thus within the spirit and scope of the present disclosure. All patents and publications cited herein are incorporated herein by reference in their entireties.
The present application is a continuation of U.S. Patent Application Ser. No. 15/916,020 filed on Mar. 8, 2018, which is a division of U.S. patent application Ser. No. 14/233,985 filed on Jun. 3, 2014 and since abandoned, which is a U.S. National Stage of PCT Application No. PCT/US2012/047708 filed on Jul. 20, 2012, which relates to and claims priority from U.S. Provisional Patent Application Ser. No. 61/510,242 filed on Jul. 21, 2011, the disclosures of all of which are incorporated herein by reference in their entireties.
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| Number | Date | Country | |
|---|---|---|---|
| 20230065372 A1 | Mar 2023 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61510242 | Jul 2011 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14233985 | US | |
| Child | 15916020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15916020 | Mar 2018 | US |
| Child | 17659945 | US |
