Patent Description:
The transfer of adipose tissue to various regions of the body is a relatively common cosmetic, therapeutic and structural procedure involving the harvest of adipose tissue from one location and re-implantation of the harvested and, oftentimes processed tissue, in another location (see Coleman <NUM>; and Coleman <NUM>). While being largely used for repair of small cosmetic defects such as facial folds, wrinkles, pock marks and divots; the transfer of adipose tissue has recently been used for cosmetic and/or therapeutic breast augmentation and reconstruction (Bircoll and Novack <NUM>; and Dixon <NUM>), and augmentation of the buttocks (Cardenas-Camarena, Lacouture et al. <NUM>; de Pedroza <NUM>; and Peren, Gomez et al.

In the past, adipose tissue grafts and methods of adipose tissue transfer have been plagued with difficulties and side effects including necrosis, absorption of the implant by the body, infection (Castello, Barros et al. <NUM>; Valdatta, Thione et al. <NUM>), calcifications and scarring (Huch, Kunzi et al. <NUM>), inconsistent engraftment, (Eremia and Newman <NUM>), lack of durability, and other problems arising from lack of neovascularization and necrosis of the transplanted tissue. One of the biggest challenges in adipose tissue transfer is absorption of the implant by the body and volume retention of adipose tissue grafts following transfer. When adipose tissue is harvested or washed, the space between individual pieces of harvested adipose tissue is filled by liquid (e.g., water, blood, tumescent solution, oil). When this tissue/fluid mixture is implanted into a recipient the liquid portion is rapidly absorbed by the body resulting in loss of volume. The process by which the amount of fluid is removed from the tissue/fluid mixture is frequently referred to as "drying the adipose tissue" or "dehydrating the adipose tissue". The content of red and white blood cells and the like within an adipose tissue graft can also significantly affect the volume of graft retained after graft transplantation, due to induction or exacerbation of an inflammatory response. Another aspect of tissue retention relates to the amount of lipid within the adipose tissue graft. It understood that the presence of free lipid (meaning lipids released from dead or damaged adipocytes; also referred to as oil) in adipose tissue grafts can result in induction or exacerbation of an inflammatory response with substantial phagocytic activity and consequent loss of graft volume.

It is also known that mixing unprocessed adipose tissue with a concentrated population of adipose-derived regenerative cells overcomes many of the problems associated with adipose tissue grafts and adipose tissue transfer, as described above. Specifically, supplementing unprocessed adipose tissue with concentrated populations of adipose-derived cells comprising adipose-derived stem cells increases the weight, vascularization, and retention of fat grafts. (See <CIT> and co-pending <CIT>). Adipose tissue fragments supplemented, or mixed, with a concentrated population of cells including adipose-derived stem cells exhibit improved neoangiogeneis and perfusion in grafts when compared to unsupplemented grafts of adipose tissue alone in animal models. Further, adipose tissue grafts supplemented with adipose-derived regenerative cells that comprise adipose derived stem cells show increased graft retention and weight over time, when compared to unsupplemented grafts. (See <CIT>). Further, the processing of adipose tissue in a closed, sterile fluid pathway greatly reduces the chance of infection. The improvement in autologous transfer of adipose tissue seen in the animal models described above has also been replicated in human clinical studies. Nevertheless, the isolation and purification of concentrated populations of adipose-derived regenerative cells comprising adipose-derived stem cells (ADSCs), usually involves a series of washing, digestion, filtration and/or centrifugation steps, which can reduce the yield of viable cells, require mechanical equipment and specialized clinicians, and/or can compromise the quality, appearance, longevity, hydration or efficacy of the graft.

Additionally, stresses could cause undesirable reactions to harvested adipose tissues. Such stresses include, for example, exposure to environmental pathogens, which are mentioned above, and prolonged post-harvest storage, etc..

While devices and systems, for example the devices described in <CIT>, were developed to address the above issues and needs, the need for additional approaches to prepare and optimize adipose tissue grafts and implants and to isolate and/or concentrate adipose-derived regenerative cells remains. <CIT> discloses a handpiece and a cutting tool wherein the tool is inserted through the conduit and percutaneously inserted into a tissue disposed within a recessed area of the handpiece. The embodiments described below address such the above-identified needs.

The micro-lipo needle device according to the invention is defined in claim <NUM>. The method of fabricating according to the invention is defined in claim <NUM>.

The device may further comprise a vacuum interlock element that prevents the needle from entering the cavity unless the cavity is under sufficient vacuum to ensure the skin being raised into a safe position for liposuction.

The needle and cannula may be a matched set that form a concentric seal, limiting leakage.

The device may further comprise a mechanism that safe-guards travel of the needle such that the travel of needle only pokes through the dermis without further insertion into the fat tissue to allow a cannula to penetrate the dermis.

The mechanism may further comprise a track that allows the needle to slide on in <NUM> dimension.

The mechanism may further comprise a spring mechanism to ensure the needle is returned to a safe position after use.

The membrane may further be a silicone membrane.

The devices comprises an assembly, which assembly comprising the sweep mechanism may further comprise a carriage housing and a needle carriage and may articulate to allow the cannula to cover a larger volume of fat tissue for liposuction, wherein the assembly is capable of navigating the body in <NUM> dimensions.

The assembly comprises a sweep mechanism that allows the cannula to sweep over a range of certain degrees.

The sweep mechanism may comprise detents every <NUM> degrees and allows the cannula to sweep over a range of <NUM> degrees.

The sweep mechanism may comprise <NUM> or more vertical positions at anywhere from <NUM> - <NUM> below the skin to allow harvesting tissue in two planes defined by the <NUM> or more vertical positions.

The device may be a one-time-use and disposable (single patient, single use aka SPSU) device.

The cannua is attached to a tissue filtration/purification system.

The tissue filtration/purification system may be a Puregraft™ bag or Puregraft™ syringe.

The device may be used in non-claimed methods of micro- liposuction, comprising: harvesting a volume of fat tissue from a subject using a micro-lipo needle device.

In these methods, the device may comprise optionally in combination with any of the various embodiments disclosed herein:.

In these methods, the device may further comprise, optionally in combination with any of the various embodiments disclosed herein, a vacuum interlock element that prevents the needle from entering the cavity unless the cavity is under sufficient vacuum to ensure the skin being raised into a safe position for liposuction.

In these methods, the needle and cannula may be a matched set that form a concentric seal, limiting leakage.

In these methods, the device further may comprise, optionally in combination with any of the various embodiments disclosed herein, a mechanism that safe-guards travel of the needle such that the travel of needle only pokes through the dermis without further insertion into the fat tissue to allow a cannula to penetrate the dermis.

In these methods, the mechanism may comprise, optionally in combination with any of the various embodiments disclosed herein, a track that allows the needle to slide on in <NUM> dimension.

In these methods, the mechanism may comprise, optionally in combination with any of the various embodiments disclosed herein, a spring mechanism to ensure the needle is returned to a safe position after use.

In these methods, the membrane may be a silicone membrane.

In these methods, the device may comprise, optionally in combination with any of the various embodiments disclosed herein, the assembly, which assembly comprises a carriage housing and a needle carriage and articulates to allow the cannula to cover a larger volume of fat tissue for liposuction, wherein the assembly is capable of navigating the body in <NUM> dimensions.

In these methods, the assembly may further comprise, optionally in combination with any of the various embodiments disclosed herein, a sweep mechanism that allows the cannula to sweep over a range of certain degrees.

In these methods, the sweep mechanism may comprise, optionally in combination with any of the various embodiments disclosed herein, vertical positions to allow harvesting tissue in multiple planes.

In these methods, the sweep mechanism may comprise, optionally in combination with any of the various embodiments disclosed herein, detents every <NUM> degrees and allows the cannula to sweep over a range of <NUM> degrees.

In these methods, optionally in combination with any of the various embodiments disclosed herein,.

In a further aspect of the present invention, it is provided a method of fabricating a micro-lipo needle device as in accordance with the claims.

The device fabricated using the method may further comprise a vacuum interlock element that prevents the needle from entering the cavity unless the cavity is under sufficient vacuum to ensure the skin being raised into a safe position for liposuction.

The device fabricated using the method may further comprise the needle and the cannula being a matched set that form a concentric seal, limiting leakage.

The device fabricated using the method may further comprise a mechanism that safe-guards travel of the needle such that the travel of needle only pokes through the dermis without further insertion into the fat tissue to allow a cannula to penetrate the dermis.

The mechanism may comprise a track that allows the needle to slide on in <NUM> dimension.

The mechanism may comprise a spring mechanism to ensure the needle is returned to a safe position after use.

The membrane may be a silicone membrane.

The assembly comprising the sweep mechanism may further comprise a carriage housing and a needle carriage and may articulate to allow the cannula to cover a larger volume of fat tissue for liposuction, wherein the assembly is capable of navigating the body in <NUM> dimensions.

The cannula may be attached to a tissue filtration/purification system.

As used herein, the term "adipose tissue" is used interchangeably with the term "fat", the meaning of which is well known to a person of ordinary skill in the art.

As used herein, the term "adipose tissue removal" or "tissue removal" or "harvesting" or "liposuction" are used interchangeably to mean remove an amount of adipose tissue from a live subject such as a male or female patient.

As used herein, the term "tissue filtration/purification system" refers to a device or system used to purify harvested fat tissue or filter off undesirable component(s) from harvested fat tissue. Examples of such a tissue filtration/purification system is a Puregraft™ system or bag as described in <CIT> or a Puregraft™ syringe as described in <CIT> and <CIT>.

Whenever is used, the term "collapsible" refers to the attribute of a material capable of collapsing under pressure or vacuum or capable of changing of shape or contour or of deformation in response to pressure change, and as such, in some embodiments, the term "collapsible" can mean deformable. An example of a material that is collapsible is a plastic or polymeric material forming a bag, e.g., a bag that is described in <CIT>.

In one aspect of the present invention, it is provided a micro-lipo needle device, as in accordance with the claims.

In some embodiments of the invention device, optionally in combination with any of the various embodiments disclosed herein, the device further comprises a vacuum interlock element that prevents the needle from entering the cavity unless the cavity is under sufficient vacuum to ensure the skin being raised into a safe position for liposuction.

In some embodiments of the invention device, optionally in combination with any of the various embodiments disclosed herein, the needle and cannula are a matched set that form a concentric seal, limiting leakage.

In some embodiments of the invention device, optionally in combination with any of the various embodiments disclosed herein, the device further comprises a mechanism that safe-guards travel of the needle such that the travel of needle only pokes through the dermis without further insertion into the fat tissue to allow a cannula to penetrate the dermis.

In some embodiments of the invention device, optionally in combination with any of the various embodiments disclosed herein, the mechanism comprises a track that allows the needle to slide on in <NUM> dimension.

In some embodiments of the invention device, optionally in combination with any of the various embodiments disclosed herein, the mechanism comprises a spring mechanism to ensure the needle is returned to a safe position after use.

In some embodiments of the invention device, optionally in combination with any of the various embodiments disclosed herein, the membrane is a silicone membrane.

In some embodiments of the invention device, optionally in combination with any of the various embodiments disclosed herein, the device comprises the assembly, which assembly comprising the sweep mechanism further comprises a carriage housing and a needle carriage and articulates to allow the cannula to cover a larger volume of fat tissue for liposuction, wherein the assembly is capable of navigating the body in <NUM> dimensions.

The invention device comprises a sweep mechanism that allows the cannula to sweep over a range of certain degrees.

In some embodiments of the invention device, optionally in combination with any of the various embodiments disclosed herein, the sweep mechanism comprises detents every <NUM> degrees and allows the cannula to sweep over a range of <NUM> degrees.

In some embodiments of the invention device, optionally in combination with any of the various embodiments disclosed herein, the sweep mechanism comprises <NUM> or more vertical positions at anywhere from <NUM> - <NUM> below the skin to allow harvesting tissue in two planes defined by the <NUM> or more vertical positions.

In some embodiments of the invention device, optionally in combination with any of the various embodiments disclosed herein, the device is a one-time-use and disposable (single patient, single use aka SPSU) device.

In some embodiments of the invention device, optionally in combination with any of the various embodiments disclosed herein, the cannua is attached to a tissue filtration/purification system.

In some embodiments of the invention device, optionally in combination with any of the various embodiments disclosed herein, the tissue filtration/purification system is a Puregraft™ bag or Puregraft™ syringe.

In one aspect of the present invention, it is provided a micro-lipo needle device as in accordance with the claims. Such device includes needles and cannula for fat harvest, which can be used independently or together with a liposuction fat transfer system such as a syringe filtration system as described in <CIT>, entitled "Liposuction Device and Use thereof".

In some embodiments, the disclosed device includes one or more of the following elements:.

In some embodiments, all of the above is one-time-use and disposable (single patient, single use aka SPSU), which would avoid cross-contamination among the patients.

Some further embodiments of the invention device are described in <FIG>: <FIG> shows a prototype of a micro-lipo needle device having a main housing <NUM>, carriage housing <NUM>, needle carriage <NUM>, and a vacuum port <NUM>.

<FIG> shows the micro-lipo needle device of of <FIG> in more detail. Referring to <FIG>, the micro-lipo needle device includes the following elements: a main housing <NUM>, a carriage housing <NUM>, a needle carriage <NUM>, a carriage washer <NUM>, a lancet point needle <NUM>, a compressing spring <NUM>, a vacuum port <NUM>, a cannula <NUM>, a needle bonding adhesive <NUM>, and a silicone sealing membrane <NUM>.

<FIG> shows an embodiment of micro-lipo needle device shown with cannula (blue/silver) inserted from right side. <FIG> is the micro-lipo needle device of <FIG> showing articulation, <NUM>, of needle/cannula.

The following method of use is not claimed but is useful for the understanding of the invention.

A method of micro-liposuction, comprises:
harvesting a volume of fat tissue from a subject using a micro-lipo needle device of invention.

The method, optionally in combination with any of the various embodiments disclosed herein, the device comprises:.

The method, optionally in combination with any of the various embodiments disclosed herein, the device further comprises a vacuum interlock element that prevents the needle from entering the cavity unless the cavity is under sufficient vacuum to ensure the skin being raised into a safe position for liposuction.

The method, optionally in combination with any of the various embodiments disclosed herein, the needle and cannula are a matched set that form a concentric seal, limiting leakage.

The method, optionally in combination with any of the various embodiments disclosed herein, the device further comprises a mechanism that safe-guards travel of the needle such that the travel of needle only pokes through the dermis without further insertion into the fat tissue to allow a cannula to penetrate the dermis.

The method, optionally in combination with any of the various embodiments disclosed herein, the mechanism comprises a track that allows the needle to slide on in <NUM> dimension.

The method, optionally in combination with any of the various embodiments disclosed herein, the mechanism comprises a spring mechanism to ensure the needle is returned to a safe position after use.

The method, optionally in combination with any of the various embodiments disclosed herein, the membrane is a silicone membrane.

The method, optionally in combination with any of the various embodiments disclosed herein, the device comprises the assembly, which assembly comprises a carriage housing and a needle carriage and articulates to allow the cannula to cover a larger volume of fat tissue for liposuction, wherein the assembly is capable of navigating the body in <NUM> dimensions.

The method, optionally in combination with any of the various embodiments disclosed herein, the assembly further comprises a sweep mechanism that allows the cannula to sweep over a range of certain degrees.

The method, optionally in combination with any of the various embodiments disclosed herein, the sweep mechanism comprises vertical positions to allow harvesting tissue in multiple planes.

The method, optionally in combination with any of the various embodiments disclosed herein, the sweep mechanism comprises detents every <NUM> degrees and allows the cannula to sweep over a range of <NUM> degrees.

The method, optionally in combination with any of the various embodiments disclosed herein, the sweep mechanism comprises <NUM> or more vertical positions at anywhere from <NUM> - <NUM> below the skin to allow harvesting tissue in two planes defined by the <NUM> or more vertical positions.

The method, optionally in combination with any of the various embodiments disclosed herein, the device is a one-time-use and disposable (single patient, single use aka SPSU) device.

The method, optionally in combination with any of the various embodiments disclosed herein, the cannua is attached to a tissue filtration/purification system.

In the method, optionally in combination with any of the various embodiments disclosed herein, the tissue filtration/ purification system is a Puregraft™ bag or Puregraft™ syringe.

The method, optionally in combination with any of the various embodiments disclosed herein, the subject is a human being.

The device of invention can use to remove or harvest adipose tissue from an area of the body. Exemplary procedures of using the device are provided below:.

<FIG> shows that fat tissue harvesting is successfully performed using a micro-lipo needle device of invention.

In some embodiments of the invention method, optionally in combination with any of the various embodiments disclosed herein, the device further comprises a vacuum interlock element that prevents the needle from entering the cavity unless the cavity is under sufficient vacuum to ensure the skin being raised into a safe position for liposuction.

In some embodiments of the invention method, optionally in combination with any of the various embodiments disclosed herein, the needle and cannula are a matched set that form a concentric seal, limiting leakage.

In some embodiments of the invention method, optionally in combination with any of the various embodiments disclosed herein, the device further comprises a mechanism that safe-guards travel of the needle such that the travel of needle only pokes through the dermis without further insertion into the fat tissue to allow a cannula to penetrate the dermis.

In some embodiments of the invention method, optionally in combination with any of the various embodiments disclosed herein, the mechanism comprises a track that allows the needle to slide on in <NUM> dimension.

In some embodiments of the invention method, optionally in combination with any of the various embodiments disclosed herein, the mechanism comprises a spring mechanism to ensure the needle is returned to a safe position after use.

In some embodiments of the invention method, optionally in combination with any of the various embodiments disclosed herein, the membrane is a silicone membrane.

In some embodiments of the invention method, optionally in combination with any of the various embodiments disclosed herein, the device comprises the assembly, which assembly comprising the sweep mechanism further comprises a carriage housing and a needle carriage and articulates to allow the cannula to cover a larger volume of fat tissue for liposuction, wherein the assembly is capable of navigating the body in <NUM> dimensions.

The assembly further comprises a sweep mechanism that allows the cannula to sweep over a range of certain degrees.

In some embodiments of the invention method, optionally in combination with any of the various embodiments disclosed herein, the sweep mechanism comprises detents every <NUM> degrees and allows the cannula to sweep over a range of <NUM> degrees.

In some embodiments of the invention method, optionally in combination with any of the various embodiments disclosed herein, the sweep mechanism comprises <NUM> or more vertical positions at anywhere from <NUM> - <NUM> below the skin to allow harvesting tissue in two planes defined by the <NUM> or more vertical positions.

In some embodiments of the invention method, optionally in combination with any of the various embodiments disclosed herein, the device is a one-time-use and disposable (single patient, single use aka SPSU) device.

In some embodiments of the invention method, optionally in combination with any of the various embodiments disclosed herein, the cannua is attached to a tissue filtration/purification system.

In some embodiments of the invention method, optionally in combination with any of the various embodiments disclosed herein, the tissue filtration/purification system is a Puregraft™ bag or Puregraft™ syringe.

In the method, the device of the invention may be used.

Designs of exemplary micro-lipo needle devices of invention are shown in <FIG>, <FIG>, <FIG>, and <FIG>.

The device of the invention may be made by 3D printing, which is shown by <FIG>.

The micro-lipo needle device may be used for liposuction in a human subject following the procedures not forming part of the invention described above. <FIG> shows that liposuction using the micro-lipo needle device is successful.

Claim 1:
A micro-lipo needle device, comprising:
a main housing (<NUM>) comprising a cavity, wherein said cavity is configured to communicate with a vacuum source such that when the main housing (<NUM>) is placed on an area of a body the vacuum source generates a degree of vacuum to cause a volume of skin and fat to be lifted so as to fill up the cavity;
a needle (<NUM>) to puncture the skin that has been lifted;
a cannula (<NUM>) to be inserted through the inner portion of the needle (<NUM>) wherein the cannula (<NUM>) is concentric with the needle (<NUM>) and constrained to <NUM> dimension, whose travel being limited such that no harm is done to a patient receiving the cannula (<NUM>);
an entry window in the main housing for the needle (<NUM>);
a membrane (<NUM>) that seals the entry window to prevent leakage; and
an assembly comprising the needle (<NUM>) and the cannula (<NUM>),
wherein the assembly comprises a sweep mechanism that allows the cannula to sweep over a range of certain degrees, wherein the sweep mechanism comprises vertical positions configured to allow harvesting tissue in multiple planes.