CLOSED-LOOP ADIPOSE TRANSPLANT SYSTEMS AND KITS, CONTROLLERS, AND METHODS RELATED THERETO

Disclosed herein are kits of consumable parts for a closed-loop adipose transplant system, closed-loop adipose transplant systems, controllers therefor, and methods of use thereof.

BACKGROUND

Autologous fat grafting is a surgical procedure that involves harvesting, processing, and transferring adipose tissue from one anatomical region of the patient to another.

Fat grafting is mainly used for the treatment of volume and contour abnormalities and congenital breast deformities. It is a technically demanding and time-consuming procedure involving several steps to harvest, process, and transfer fat.

Currently there are few devices to facilitate fat graft transfer, all have significant limitations. These limitations include intraoperative inefficiency, inability to graft and process at the same time, ergonomics, manual injection, and quality of fat harvested.

The devices, methods, and systems discussed herein addresses these and other needs.

SUMMARY

In accordance with the purposes of the disclosed devices, methods, and systems as embodied and broadly described herein, the disclosed subject matter relates to kits of consumable parts for a closed-loop adipose transplant system, closed-loop adipose transplant systems, controllers therefor, and methods of use thereof.

Additional advantages of the disclosed devices, systems, and methods will be set forth in part in the description which follows, and in part will be obvious from the description. The advantages of the disclosed devices, systems, and methods will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosed systems and methods, as claimed.

DETAILED DESCRIPTION

As used in the description and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a composition” includes mixtures of two or more such compositions, reference to “an agent” includes mixtures of two or more such agents, reference to “the component” includes mixtures of two or more such components, and the like.

It is understood that throughout this specification the identifiers “first” and “second” are used solely to aid in distinguishing the various components and steps of the disclosed subject matter. The identifiers “first” and “second” are not intended to imply any particular order, amount, preference, or importance to the components or steps modified by these terms.

A weight percent (wt. %) of a component, unless specifically stated to the contrary, is based on the total weight of the formulation or composition in which the component is included. As used herein, by a “subject” is meant an individual. Thus, the “subject” can include domesticated animals (e.g., cats, dogs, etc.), livestock (e.g., cattle, horses, pigs, sheep, goats, etc.), laboratory animals (e.g., mouse, rabbit, rat, guinea pig, etc.), and birds. “Subject” can also include a mammal, such as a primate or a human. Thus, the subject can be a human or veterinary patient. The term “patient” refers to a subject under the treatment of a clinician, e.g., physician.

Kits and Systems

Disclosed herein are kits of consumable parts for a closed-loop adipose transplant system (e.g., a closed-loop autologous fat grafting system).

Referring now toFIG.1, disclosed herein are kits100of consumable parts for a closed-loop adipose transplant system including a liposuction cannula900, a first tube902, a first pump904, a second pump906, and an injector908, the kit100comprising: a collection canister102; a second tube104; an adipose separation module200having an inlet202and an outlet204; a third tube106; a collection reservoir108; and a fourth tube110; wherein the consumable parts of the kit100together form a continuous, closed fluid pathway for the adipose tissue from the liposuction cannula900to the collection canister102through the first tube902, from the collection canister102to the inlet202of the adipose separation module200through the second tube104, from the inlet202to the outlet204through the adipose separation module200, from the outlet204of the adipose separation module200to the collection reservoir108through the third tube106, and from the collection reservoir108to the injector908through the fourth tube110.

The collection canister102is configured to receive and collect a mixture comprising adipose tissue harvested from a first anatomical region by the liposuction cannula900via the first tube902.

The collection canister102can, for example, comprise any suitable container for collecting adipose tissue, such as those known in the art. In some examples, the collection canister102can comprise a suction canister or a vacutainer, such as a liposuction vacutainer. The collection canister102can, for example, comprise any suitable material, such as those known in the art. For example, the collection canister102can comprise glass, a polymer, or a combination thereof. For example, the collection canister102can comprise a polymer liner disposed inside of a rigid canister.

The collection canister102is a closed container configured to be fluidly coupled to the first tube902and the second tube104. For example, the collection canister102can have an interior volume defined by a wall, wherein the wall has one or more ports independently configured to receive the first tube902and/or the second tube104, such that the interior volume of the collection canister102is fluidly connected to the first tube902and the second tube104. In some examples, the collection canister102can comprise a body and a lid, wherein the lid is configured to be coupled to the body (e.g., removably coupled), such that when the lid and the body are coupled they define the interior volume. The lid can, for example, have a first port and a second port, the first port being configured to receive the first tube904and the second port being configured to receive the second tube104.

The second tube104is configured to fluidly connect the collection canister102to the inlet202of the adipose separation module200. The second tube104is further configured to fluidly connect the first pump904to the collection canister102and the adipose separation module200, such that the second tube104communicates a pressure applied by the first pump904, the pressure being sufficient to: transport the mixture through the second tube104from the collection canister102to the inlet202of the adipose separation module200. In some examples, the pressure applied by the first pump904is sufficient to overcome the liposuction pressure in the collection canister102.

The adipose separation module200is configured to: receive the mixture from the collection canister102through the inlet202and separate the adipose tissue from the mixture, thereby concentrating the adipose tissue from the mixture.

The third tube106is configured to fluidly connect the outlet204of the adipose separation module200to the collection reservoir108.

The collection reservoir108is configured to receive and collect the concentrated adipose tissue from outlet204of the adipose separation module200via the third tube106.

The collection reservoir108can, for example, comprise any suitable container for collecting adipose tissue, such as those known in the art. In some examples, the collection reservoir108can comprise a sterile medical collection bag.

The collection reservoir108can, for example, comprise any suitable material, such as those known in the art. For example, the collection reservoir108can comprise glass, a polymer, or a combination thereof. The collection reservoir108can, for example, be rigid or flexible. In some examples, the collection reservoir108can expand as it is filled with adipose tissue.

The collection reservoir108is a closed container configured to be fluidly coupled to the third tube106and the fourth tube110. For example, the collection reservoir108can have an interior volume defined by a wall, wherein the wall has one or more ports independently configured to receive the third tube106and/or the fourth tube110, such that the interior volume of the collection reservoir108is fluidly connected to the third tube106and the fourth tube110. In some examples, the collection reservoir108can comprise a body and a lid, wherein the lid is configured to be coupled to the body (e.g., removably coupled), such that when the lid and the body are coupled they define the interior volume. The lid can, for example, have a first port and a second port, the first port being configured to receive the third tube106and the second port being configured to receive the fourth tube110.

The fourth tube110is configured to fluidly connect the collection reservoir108to the injector908. The fourth tube110is further configured to fluidly connect the second pump906to the collection reservoir108and the injector908, such that the fourth tube110communicates a pressure applied by the second pump906, the pressure being sufficient to: transport the concentrated adipose through the fourth tube110from the collection reservoir108to the injector908and inject the concentrated adipose tissue into a second anatomical region.

The adipose separation module200has an inlet202and an outlet204and is configured to: receive the mixture from the collection canister102through the inlet202and separate the adipose tissue from the mixture, thereby concentrating the adipose tissue from the mixture. For example, the adipose separation module200can be configured to filter the viable adipose tissue from plasma, blood remnants, lysed adipocyte cells, etc.

In some examples, the adipose separation module200is further configured to contact the mixture with a wash liquid, thereby washing the mixture, and to separate the adipose tissue from the mixture and the wash liquid, thereby concentrating the adipose tissue. The wash liquid can comprise any suitable wash liquid, such as those known in the art. Examples of suitable wash liquids include, but are not limited to, saline, lactated ringer's, collagenase, pH buffers, sterile water, and combinations thereof. In some examples, the wash liquid comprises saline, lactated ringers, or a combination thereof.

Referring now toFIG.2, the adipose separation module200can, in some examples, further comprise an orifice205and the adipose separation module200can be configured to receive the wash liquid through the orifice205. The orifice205of the adipose separation module200can, for example, have an inner diameter of 1 millimeter (mm) or more (e.g., 1.25 mm or more, 1.5 mm or more, 1.75 mm or more, 2 mm or more, 2.25 mm or more, 2.5 mm or more, 2.75 mm or more, 3 mm or more, 3.25 mm or more, 3.5 mm or more, 3.75 mm or more, 4 mm or more, 4.25 mm or more, 4.5 mm or more, 4.75 mm or more, 5 mm or more, 5.25 mm or more, 5.5 mm or more, or 5.75 mm or more). In some examples, the orifice205of the adipose separation module200can have an inner diameter of 6 mm or less (e.g., 5.75 mm or less, 5.5 mm or less, 5.25 mm or less, 5 mm or less, 4.75 mm or less, 4.5 mm or less, 4.25 mm or less, 4 mm or less, 3.75 mm or less, 3.5 mm or less, 3.25 mm or less, 3 mm or less, 2.75 mm or less, 2.5 mm or less, 2.25 mm or less, 2 mm or less, 1.75 mm or less, 1.5 mm or less, or 1.25 mm or less). The inner diameter of the orifice205the adipose separation module200can range from any of the minimum values described above to any of the maximum values described above. For example, the orifice205of the adipose separation module200can have an inner diameter of from 1 millimeter (mm) to 6 mm (e.g., from 1 mm to 3.5 mm, from 3.5 mm to 6 mm, from 1 mm to 2 mm, from 2 mm to 3 mm, from 3 mm to 4 mm, from 4 mm to 5 mm, from 5 mm to 6 mm, from 1 mm to 5.5 mm, from 1.5 mm to 5.5 mm, from 1.5 mm to 5.5 mm, from 2 mm to 6 mm, from 3 mm to 6 mm, from 4 mm to 6 mm, or from 5.25 mm to 5.5 mm).

The orifice205can, for example, be configured to be fluidly connected to a wash liquid reservoir910configured to contain the wash liquid, for example via a fifth tube912. For example, the orifice205can be configured to be fluidly connected to the fifth tube912, wherein the fifth tube912is configured to fluidly connect the orifice205of the adipose separation module200to a wash liquid reservoir910configured to contain the wash liquid. In some examples, the kit100further comprises a fifth tube912configured to fluidly connect the orifice205of the adipose separation module200to a wash liquid reservoir910configured to contain the wash liquid. In some examples, the kit100can further comprise a wash liquid reservoir910configured to be fluidly connected to the orifice205. In some examples, the kit100can further comprise the fifth tube912and the wash liquid reservoir910.

The wash liquid reservoir910can, for example, comprise any suitable container for containing a wash liquid, such as those known in the art. The wash liquid reservoir910can, for example, comprise any suitable material, such as those known in the art. For example, the wash liquid reservoir910can comprise a polymer, glass, or a combination thereof. In some examples, the wash liquid reservoir910can be rigid or flexible. In some examples, the wash liquid reservoir910can comprise a sterile medical collection bag, a rigid polymer vessel, a glass vessel, or a combination thereof.

Referring now toFIG.3, in some examples, the adipose separation module200further comprises: a housing206defining an interior cavity208, the inlet202, the outlet204, and the orifice205(when present). In some examples, the adipose separation module200further comprises a filter210configured to be disposed within the interior cavity208, such that the filter210is configured to define a first compartment212and a second compartment214within the interior cavity208, the first compartment212being a portion of the interior cavity208encompassed by the filter210and the second compartment214being a portion of the interior cavity208outside the filter210; wherein the first compartment212has a proximal end216and a distal end218, the inlet202of the adipose separation module200being fluidly connected to the first compartment212at or near the proximal end216of the first compartment212, and the outlet204of the adipose separation module200being fluidly connected to the first compartment212at or near the distal end218of the first compartment212. In some examples, the orifice205of the adipose separation module (when present), can be fluidly connected to the interior cavity208. The housing206can have a top surface220, and the orifice205(when present) can be defined by the top surface220of the housing206.

In some examples, the filter210is configured to separate the adipose tissue from the wash liquid (when present) and other components in the mixture by passing the wash liquid (when present) and the other components from the mixture through the filter210into the second compartment214as the mixture is transported through the housing206, thereby concentrating the adipose tissue within the first compartment212and forming an effluent in the second compartment214, the effluent comprising the wash liquid (when present) and the other components from the mixture.

The housing206can comprise any suitable material, such as those known in the art. Examples of suitable materials for the housing206include, but are not limited to, polymers, such as transparent and semi-transparent polymers. In some examples, the housing206can comprise polycarbonate, acrylonitrile butadiene styrene (ABS), poly(methyl methacrylate) (PMMA), polyvinyl chloride (PVC), an acrylic (e.g., a polyacrylic), nylon, polyester, polytetrafluoroethylene (PTFE), an acetal resin (e.g., Delrin®), polyether ether ketone (PEEK), derivatives thereof, or combinations thereof. In some examples, the housing206can comprise polycarbonate.

The housing206can have any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. For example, the housing206can be a polyhedron (e.g., a platonic solid, a prism, a pyramid), a cylinder, a hemicylinder, an elliptical cylinder, a hemi-elliptical cylinder, a cone, a semicone, etc. In some examples, the housing206can have a cylindrical shape.

The housing206has a longitudinal axis, a proximal end, and a distal end opposite and axially spaced apart from the proximal end. The housing206has a length, the length being the dimension along the longitudinal axis from the proximal end to the distal end (e.g., “L” inFIG.3). In some examples, the housing206has a length of 50 mm or more (e.g., 55 mm or more, 60 mm or more, 65 mm or more, 70 mm or more, 75 mm or more, 80 mm or more, 85 mm or more, 90 mm or more, 95 mm or more, 100 mm or more, 110 mm or more, 120 mm or more, 130 mm or more, 140 mm or more, 150 mm or more, 160 mm or more, 170 mm or more, 180 mm or more, or 190 mm or more). In some example, the housing206has a length of 200 mm or less (e.g., 190 mm or less, 180 mm or less, 170 mm or less, 160 mm or less, 150 mm or less, 140 mm or less, 130 mm or less, 120 mm or less, 110 mm or less, 100 mm or less, 95 mm or less, 90 mm or less, 85 mm or less, 80 mm or less, 75 mm or less, 70 mm or less, 65 mm or less, 60 mm or less, or 55 mm or less). The length of the housing206can range from any of the minimum values described above to any of the maximum values described above. For example, the housing206can have a length of from 50 mm to 200 mm (e.g., from 50 mm to 125 mm, from 125 mm to 200 mm, from 50 mm to 100 mm, from 100 mm to 150 mm, from 150 mm to 200 mm, from 50 mm to 175 mm, from 75 mm to 200 mm, from 75 mm to 174 mm, from 50 mm to 150 mm, from 60 mm to 90 mm, from 70 mm to 80 mm, or from 75 mm to 80 mm). In some examples, the housing206can have a length of from 75 mm to 80 mm.

The housing206can have a cross-sectional shape in a plane perpendicular to the longitudinal axis, wherein the cross-sectional shape can be any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. In some examples, the cross-sectional shape of the housing206can be substantially circular, ovate, ovoid, elliptic, triangular, rectangular, polygonal, etc.

The housing206can have an average characteristic dimension. The term “characteristic dimension,” as used herein refers to the largest straight line distance between two points in the plane of the cross-sectional shape of the housing206. “Average characteristic dimension” and “mean characteristic dimension” are used interchangeably herein, and generally refer to the statistical mean characteristic dimension. For example, for a cylindrical housing206, the cross-sectional shape can be substantially circular and the average characteristic dimension can refer to the average diameter.

For example, the housing206can have an average characteristic dimension of 15 mm or more (e.g., 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 26 mm or more, 27 mm or more, 28 mm or more, 29 mm or more, 30 mm or more, 31 mm or more, 32 mm or more, 33 mm or more, 34 mm or more, 35 mm or more, 36 mm or more, 37 mm or more, 38 mm or more, 39 mm or more, 40 mm or more, 45 mm or more, 50 mm or more, 55 mm or more, 60 mm or more, 65 mm or more, or 70 mm or more). In some examples, the housing206can have an average characteristic dimension of 75 mm or less (e.g., 70 mm or less, 65 mm or less, 60 mm or less, 55 mm or less, 50 mm or less, 45 mm or less, 40 mm or less, 39 mm or less, 38 mm or less, 37 mm or less, 36 mm or less, 35 mm or less, 34 mm or less, 33 mm or less, 32 mm or less, 31 mm or less, 30 mm or less, 29 mm or less, 28 mm or less, 27 mm or less, 26 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, or 16 mm or less). The average characteristic dimension of the housing206can range from any of the minimum values described above to any of the maximum values described above. For example, the housing206can have an average characteristic dimension of from 15 mm to 75 mm (e.g., from 15 mm to 45 mm, from 45 mm to 75 mm, from 15 mm to 35 mm, from 35 mm to 55 mm, from 55 mm to 75 mm, from 15 mm to 70 mm, from 20 mm to 75 mm, from 20 mm to 70 mm, from 20 mm to 40 mm, or from 30 mm to 36 mm).

The interior cavity208can have any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. For example, the interior cavity208can be a polyhedron (e.g., a platonic solid, a prism, a pyramid), a cylinder, a hemicylinder, an elliptical cylinder, a hemi-elliptical cylinder, a cone, a semicone, etc. In some examples, the interior cavity208can have a cylindrical shape.

The interior cavity208has a longitudinal axis, a proximal end, and a distal end opposite and axially spaced apart from the proximal end. The interior cavity208has a length, the length being the dimension along the longitudinal axis from the proximal end to the distal end. The interior cavity208can have a length of 25 mm or more (e.g., 30 mm or more, 35 mm or more, 40 mm or more, 45 mm or more, 50 mm or more, 55 mm or more, 60 mm or more, 65 mm or more, 70 mm or more, 75 mm or more, 80 mm or more, 85 mm or more, 90 mm or more, 95 mm or more, 100 mm or more, 105 mm or more, 110 mm or more, 115 mm or more, 120 mm or more, 125 mm or more, 130 mm or more, 135 mm or more, 140 mm or more, or 145 mm or more). In some examples, the interior cavity208can have a length of 150 mm or less (e.g., 145 mm or less, 140 mm or less, 135 mm or less, 130 mm or less, 125 mm or less, 120 mm or less, 115 mm or less, 110 mm or less, 105 mm or less, 100 mm or less, 95 mm or less, 90 mm or less, 85 mm or less, 80 mm or less, 75 mm or less, 70 mm or less, 65 mm or less, 60 mm or less, 55 mm or less, 50 mm or less, 45 mm or less, 40 mm or less, 35 mm or less, or 30 mm or less). The length of the interior cavity208can range from any of the minimum values described above to any of the maximum values described above. For example, the interior cavity208can have an length of from 25 mm to 150 mm (e.g., from 25 mm to 90 mm, from 90 mm to 150 mm, from 25 mm to 50 mm, from 50 mm to 75 mm, from 75 mm to 100 mm, from 100 mm to 125 mm, from 125 mm to 150 mm, from 30 mm to 150 mm, from 25 mm to 145 mm, from 30 mm to 145 mm, from 30 mm to 75 mm, or from 60 mm to 70 mm).

The interior cavity208can have a cross-sectional shape in a plane perpendicular to the longitudinal axis, wherein the cross-sectional shape can be any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. In some examples, the cross-sectional shape of the interior cavity208can be substantially circular, ovate, ovoid, elliptic, triangular, rectangular, polygonal, etc.

The interior cavity208can have an average characteristic dimension. The term “characteristic dimension,” as used herein refers to the largest straight line distance between two points in the plane of the cross-sectional shape of the interior cavity208. “Average characteristic dimension” and “mean characteristic dimension” are used interchangeably herein, and generally refer to the statistical mean characteristic dimension. For example, for a cylindrical interior cavity208, the cross-sectional shape can be substantially circular and the average characteristic dimension can refer to the average diameter.

For example, the interior cavity208can have an average characteristic dimension of 5 mm or more (e.g., 6 mm or more, 7 mm or more, 8 mm or more, 9 mm or more, 10 mm or more, 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the interior cavity208has an average characteristic dimension of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, 11 mm or less, 10 mm or less, 9 mm or less, 8 mm or less, 7 mm or less, or 6 mm or less). The average characteristic dimension of the interior cavity208can range from any of the minimum values described above to any of the maximum values described above. For example, the interior cavity208can have an average characteristic dimension of from 5 mm to 50 mm (e.g., from 5 mm to 30 mm, from 30 mm to 50 mm, from 5 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 10 mm to 50 mm, from 5 mm to 48 mm, from 10 mm to 48 mm, from 10 mm to 25 mm, or from 15 mm to 23 mm).

The first compartment212can have any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. For example, the first compartment212can be a polyhedron (e.g., a platonic solid, a prism, a pyramid), a cylinder, a hemicylinder, an elliptical cylinder, a hemi-elliptical cylinder, a cone, a semicone, etc. In some examples, the first compartment212can have a cylindrical shape.

In some examples, the first compartment212is disposed coaxially with the filter210. The first compartment212has a longitudinal axis, with the proximal end216being opposite and axially spaced apart from the distal end218. The first compartment212has a length, the length being the dimension along the longitudinal axis from the proximal end216to the distal end218. The first compartment212can, for example, have a length of 25 mm or more (e.g., 30 mm or more, 35 mm or more, 40 mm or more, 45 mm or more, 50 mm or more, 55 mm or more, 60 mm or more, 65 mm or more, 70 mm or more, 75 mm or more, 80 mm or more, 85 mm or more, 90 mm or more, 95 mm or more, 100 mm or more, 105 mm or more, 110 mm or more, 115 mm or more, 120 mm or more, 125 mm or more, 130 mm or more, 135 mm or more, 140 mm or more, or 145 mm or more). In some examples, the first compartment212can have a length of 150 mm or less (e.g., 145 mm or less, 140 mm or less, 135 mm or less, 130 mm or less, 125 mm or less, 120 mm or less, 115 mm or less, 110 mm or less, 105 mm or less, 100 mm or less, 95 mm or less, 90 mm or less, 85 mm or less, 80 mm or less, 75 mm or less, 70 mm or less, 65 mm or less, 60 mm or less, 55 mm or less, 50 mm or less, 45 mm or less, 40 mm or less, 35 mm or less, or 30 mm or less). The length of the first compartment212can range from any of the minimum values described above to any of the maximum values described above. For example, the first compartment212can have a length of from 25 mm to 150 mm (e.g., from 25 mm to 90 mm, from 90 mm to 150 mm, from 25 mm to 50 mm, from 50 mm to 75 mm, from 75 mm to 100 mm, from 100 mm to 125 mm, from 125 mm to 150 mm, from 25 mm to 140 mm, from 35 mm to 150 mm, from 35 mm to 140 mm, from 60 mm to 75 mm, or from 60 mm to 70 mm).

The first compartment212can have a cross-sectional shape in a plane perpendicular to the longitudinal axis, wherein the cross-sectional shape can be any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. In some examples, the cross-sectional shape of the first compartment212can be substantially circular, ovate, ovoid, elliptic, triangular, rectangular, polygonal, etc.

The first compartment212can have an average characteristic dimension. The term “characteristic dimension,” as used herein refers to the largest straight line distance between two points in the plane of the cross-sectional shape of the first compartment212. “Average characteristic dimension” and “mean characteristic dimension” are used interchangeably herein, and generally refer to the statistical mean characteristic dimension. For example, for a cylindrical first compartment212, the cross-sectional shape can be substantially circular and the average characteristic dimension can refer to the average diameter.

For example, the first compartment212can have an average characteristic dimension of mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the first compartment212has an average characteristic dimension of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, or 11 mm or less). The average characteristic dimension of the first compartment212can range from any of the minimum values described above to any of the maximum values described above. For example, the first compartment212can have an average characteristic dimension of from 10 mm to 50 mm (e.g., from 10 mm to 30 mm, from 30 mm to 50 mm, from 10 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 12 mm to 50 mm, from 10 mm to 48 mm, from 12 mm to 48 mm, from 10 mm to 25 mm, or from 12 mm to 19 mm).

The filter210can comprise any suitable material, such as those known in the art. In some examples, the filter210can comprise a polymer, a composite material, a metal, or a combination thereof. In some examples, the filter210can comprise a polymer, such as nylon, polyester, polytetrafluoroethylene (PTFE), an acetal resin (e.g., Delrin®), polyether ether ketone (PEEK), polycarbonate, acrylonitrile butadiene styrene (ABS), poly(methyl methacrylate) (PMMA), polyvinyl chloride (PVC), an acrylic (e.g., a polyacrylic), derivatives thereof, or combinations thereof. In some examples, the filter210can comprise a metal, such as titanium, stainless steel, derivatives thereof, or combinations thereof.

The filter210can have any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. For example, the filter210can be a polyhedron (e.g., a platonic solid, a prism, a pyramid), a cylinder, a hemicylinder, an elliptical cylinder, a hemi-elliptical cylinder, a cone, a semicone, etc. In some examples, the filter210can have a cylindrical shape.

The filter210has a longitudinal axis, a proximal end, and a distal end opposite and axially spaced apart from the proximal end. The filter210has a length, the length being the dimension along the longitudinal axis from the proximal end to the distal end.

The filter210can, for example, have a length of 25 mm or more (e.g., 30 mm or more, 35 mm or more, 40 mm or more, 45 mm or more, 50 mm or more, 55 mm or more, 60 mm or more, 65 mm or more, 70 mm or more, 75 mm or more, 80 mm or more, 85 mm or more, 90 mm or more, 95 mm or more, 100 mm or more, 105 mm or more, 110 mm or more, 115 mm or more, 120 mm or more, 125 mm or more, 130 mm or more, 135 mm or more, 140 mm or more, or 145 mm or more). In some examples, the filter210can have a length of 150 mm or less (e.g., 145 mm or less, 140 mm or less, 135 mm or less, 130 mm or less, 125 mm or less, 120 mm or less, 115 mm or less, 110 mm or less, 105 mm or less, 100 mm or less, 95 mm or less, 90 mm or less, 85 mm or less, 80 mm or less, 75 mm or less, 70 mm or less, 65 mm or less, 60 mm or less, 55 mm or less, 50 mm or less, 45 mm or less, 40 mm or less, 35 mm or less, or 30 mm or less). The length of the filter210can range from any of the minimum values described above to any of the maximum values described above. For example, the filter210can have a length of from 25 mm to 150 mm (e.g., from 25 mm to 90 mm, from 90 mm to 150 mm, from 25 mm to 50 mm, from 50 mm to 75 mm, from 75 mm to 100 mm, from 100 mm to 125 mm, from 125 mm to 150 mm, from 25 mm to 140 mm, from 35 mm to 150 mm, from 35 mm to 140 mm, from 40 mm to 60 mm, or from 48 mm to 56 mm). For example, the length of the filter210can be selected in view of the length of the interior cavity208.

The filter210can have a cross-sectional shape in a plane perpendicular to the longitudinal axis, wherein the cross-sectional shape can be any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. In some examples, the cross-sectional shape of the filter210can be substantially circular, ovate, ovoid, elliptic, triangular, rectangular, polygonal, etc.

The filter210can have an average characteristic dimension. The term “characteristic dimension,” as used herein refers to the largest straight line distance between two points in the plane of the cross-sectional shape of the filter210. “Average characteristic dimension” and “mean characteristic dimension” are used interchangeably herein, and generally refer to the statistical mean characteristic dimension. For example, for a cylindrical filter210, the cross-sectional shape can be substantially circular and the average characteristic dimension can refer to the average diameter.

For example, the filter210can have an average characteristic dimension of 10 mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the filter210has an average characteristic dimension of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, or 11 mm or less). The average characteristic dimension of the filter210can range from any of the minimum values described above to any of the maximum values described above. For example, the filter210can have an average characteristic dimension of from 10 mm to 50 mm (e.g., from 10 mm to 30 mm, from 30 mm to 50 mm, from 10 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 12 mm to 50 mm, from 10 mm to 48 mm, from 12 mm to 48 mm, from 10 mm to 25 mm, or from 12 mm to 19 mm). The average characteristic dimension of the filter210can, for example, be selected in view of the average characteristic dimension of the interior cavity208.

Referring now toFIG.4, in some examples, the adipose separation module200further comprises a filter cage222disposed circumferentially around and coaxially with the filter210within the interior cavity208. The filter cage222can, for example, provide structural support and/or rigidity to the filter210.

The filter cage222can comprise any suitable material, such as those known in the art. In some examples, the filter cage222can comprise a polymer, a composite material, a metal, or a combination thereof.

The filter cage222can have any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. For example, the filter cage222can be a polyhedron (e.g., a platonic solid, a prism, a pyramid), a cylinder, a hemicylinder, an elliptical cylinder, a hemi-elliptical cylinder, a cone, a semicone, etc. In some examples, the filter cage222can have a cylindrical shape. The shape of the filter case222can be selected, for example, in view of the shape of the filter210and/or the interior cavity208.

The filter cage222has a longitudinal axis, a proximal end, and a distal end opposite and axially spaced apart from the proximal end. The filter cage222has a length, the length being the dimension along the longitudinal axis from the proximal end to the distal end.

The filter cage222can, for example, have a length of 25 mm or more (e.g., 30 mm or more, 35 mm or more, 40 mm or more, 45 mm or more, 50 mm or more, 55 mm or more, 60 mm or more, 65 mm or more, 70 mm or more, 75 mm or more, 80 mm or more, 85 mm or more, 90 mm or more, 95 mm or more, 100 mm or more, 105 mm or more, 110 mm or more, 115 mm or more, 120 mm or more, 125 mm or more, 130 mm or more, 135 mm or more, 140 mm or more, or 145 mm or more). In some examples, the filter cage222can have a length of 150 mm or less (e.g., 145 mm or less, 140 mm or less, 135 mm or less, 130 mm or less, 125 mm or less, 120 mm or less, 115 mm or less, 110 mm or less, 105 mm or less, 100 mm or less, 95 mm or less, 90 mm or less, 85 mm or less, 80 mm or less, 75 mm or less, 70 mm or less, 65 mm or less, 60 mm or less, 55 mm or less, 50 mm or less, 45 mm or less, 40 mm or less, 35 mm or less, or 30 mm or less). The length of the filter cage222can range from any of the minimum values described above to any of the maximum values described above. For example, the filter cage222can have a length of from 25 mm to 150 mm (e.g., from 25 mm to 90 mm, from 90 mm to 150 mm, from 25 mm to 50 mm, from 50 mm to 75 mm, from 75 mm to 100 mm, from 100 mm to 125 mm, from 125 mm to 150 mm, from 25 mm to 140 mm, from 35 mm to 150 mm, from 35 mm to 140 mm, from 40 mm to 60 mm, or from 48 mm to 56 mm). The length of the filter case222can be selected, for example, in view of the length of the filter210and/or the interior cavity208.

The filter cage222can have a cross-sectional shape in a plane perpendicular to the longitudinal axis, wherein the cross-sectional shape can be any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. In some examples, the cross-sectional shape of the filter cage222can be substantially circular, ovate, ovoid, elliptic, triangular, rectangular, polygonal, etc.

The filter cage222can have an average characteristic dimension. The term “characteristic dimension,” as used herein refers to the largest straight line distance between two points in the plane of the cross-sectional shape of the filter cage222. “Average characteristic dimension” and “mean characteristic dimension” are used interchangeably herein, and generally refer to the statistical mean characteristic dimension. For example, for a cylindrical filter cage222, the cross-sectional shape can be substantially circular and the average characteristic dimension can refer to the average diameter.

For example, the filter cage222can have an average characteristic dimension of 10 mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the filter cage222has an average characteristic dimension of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, or 11 mm or less). The average characteristic dimension of the filter cage222can range from any of the minimum values described above to any of the maximum values described above. For example, the filter cage222can have an average characteristic dimension of from 10 mm to 50 mm (e.g., from 10 mm to 30 mm, from 30 mm to 50 mm, from 10 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 12 mm to 50 mm, from 10 mm to 48 mm, from 12 mm to 48 mm, from 10 mm to 25 mm, or from 12 mm to 19 mm). The average characteristic dimension of the filter cage222can be selected, for example, in view of the average characteristic dimension of the filter210and/or the interior cavity208.

Referring now toFIG.5, in some examples, the adipose separation module200further comprises: a rotary implement230having longitudinal axis, a proximal end232, and a distal end234axially spaced apart from the proximal end, the rotary implement230comprising a central shaft236and a blade238extending from the central shaft236; wherein the filter is configured to be disposed circumferentially around and coaxially with the rotary implement230within the interior cavity208, such that the rotary implement230is configured to be rotatably disposed within the first compartment212with the proximal end232of the rotary implement230disposed towards the proximal end216of the first compartment212and the distal end234of the rotary implement230being disposed towards the distal end218of the first compartment212; and wherein the rotary implement230is configured to agitate the mixture within the first compartment212via rotation of the rotary implement230.

The rotary implement230can comprise any suitable material, such as those known in the art. In some examples, the rotary implement230can comprise a polymer, a composite material, a metal, or a combination thereof. In some examples, the rotary implement230can comprise polycarbonate, acrylonitrile butadiene styrene (ABS), poly(methyl methacrylate) (PMMA), polyvinyl chloride (PVC), an acrylic (e.g., a polyacrylic), nylon, polyester, polytetrafluoroethylene (PTFE), an acetal resin (e.g., Delrin®), polyether ether ketone (PEEK), derivatives thereof, or combinations thereof. In some examples, the rotary implement230can comprise polycarbonate. In some examples, the rotary implement230can comprise a metal, such as titanium, stainless steel, derivatives thereof, or combinations thereof.

The rotary implement230has a length, the length being the dimension along the longitudinal axis from the proximal end to the distal end. The rotary implement230can, for example, have a length of 25 mm or more (e.g., 30 mm or more, 35 mm or more, 40 mm or more, 45 mm or more, 50 mm or more, 55 mm or more, 60 mm or more, 65 mm or more, 70 mm or more, 75 mm or more, 80 mm or more, 85 mm or more, 90 mm or more, 95 mm or more, 100 mm or more, 105 mm or more, 110 mm or more, 115 mm or more, 120 mm or more, 125 mm or more, 130 mm or more, 135 mm or more, 140 mm or more, or 145 mm or more). In some examples, the rotary implement230can have a length of 150 mm or less (e.g., 145 mm or less, 140 mm or less, 135 mm or less, 130 mm or less, 125 mm or less, 120 mm or less, 115 mm or less, 110 mm or less, 105 mm or less, 100 mm or less, 95 mm or less, 90 mm or less, 85 mm or less, 80 mm or less, 75 mm or less, 70 mm or less, 65 mm or less, 60 mm or less, 55 mm or less, 50 mm or less, 45 mm or less, 40 mm or less, 35 mm or less, or 30 mm or less). The length of the rotary implement230can range from any of the minimum values described above to any of the maximum values described above. For example, the rotary implement230can have a length of from 25 mm to 150 mm (e.g., from 25 mm to 90 mm, from 90 mm to 150 mm, from 25 mm to 50 mm, from 50 mm to 75 mm, from 75 mm to 100 mm, from 100 mm to 125 mm, from 125 mm to 150 mm, from 25 mm to 140 mm, from 35 mm to 150 mm, from 35 mm to 140 mm, from 40 mm to 60 mm, or from 48 mm to 56 mm). The length of the rotary implement230can be selected, for example, in view of the length of the filter210and/or the interior cavity208.

For example, the central shaft236of the rotary implement230can have a diameter of 10 mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the central shaft236of the rotary implement230can have a diameter of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, or 11 mm or less). The diameter of the central shaft236of the rotary implement230can range from any of the minimum values described above to any of the maximum values described above. For example, the central shaft236of the rotary implement230can have a diameter of from 10 mm to 50 mm (e.g., from 10 mm to 30 mm, from 30 mm to 50 mm, from 10 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 12 mm to 50 mm, from 10 mm to 48 mm, from 12 mm to 48 mm, from 10 mm to 25 mm, or from 12 mm to 19 mm).

The rotary implement230has an outer diameter as measured to the edge of the blade238(e.g., edge to edge for a helical blade238). For example, the rotary implement230can have an outer diameter of 5 mm or more (e.g., 6 mm or more, 7 mm or more, 8 mm or more, 9 mm or more, 10 mm or more, 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the rotary implement230can have an outer diameter of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, 11 mm or less, 10 mm or less, 9 mm or less, 8 mm or less, 7 mm or less, or 6 mm or less). The outer diameter of the rotary implement230can range from any of the minimum values described above to any of the maximum values described above. For example, the rotary implement230can have an outer diameter of from 5 mm to 50 mm (e.g., from 5 mm to 30 mm, from 30 mm to 50 mm, from 5 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 10 mm to 50 mm, from 5 mm to 48 mm, from 10 mm to 48 mm, from 10 mm to 25 mm, or from 10 mm to 15 mm).

The rotary implement230can have any suitable configuration. Example rotary implements230are shown inFIG.6toFIG.10.

In some examples, the blade238is helically disposed about the central shaft236.

Referring now toFIG.6, in some examples, the blade238is helically disposed about the central shaft236with a variable pitch.

Referring now toFIG.7, in some examples, the blade238comprises a plurality of blades238, each of the blades238extending radially from the central shaft236and being disposed circumferentially about the central shaft236. An example adipose filtration modules using the rotary implement230as shown inFIG.7is shown inFIG.54.

In some examples, the rotary implement230comprises a first section240and a second section242, the first section240extending along a first portion of the central shaft236towards the proximal end232of the rotary implement230and the second section242being adjacent the first section and extending along a second portion of the central shaft236, wherein the first section240has a first blade238A extending from the central shaft236and the second section242has a second blade238B extending from the central shaft236.

Referring now toFIG.8, in some examples, the second blade238B is helically disposed about the central shaft236and the first blade238A comprises a plurality of first blades238A, each of the first blades238A extending radially from the central shaft236and being disposed circumferentially about the central shaft236.

Referring now toFIG.9, in some examples, the first blade238A is helically disposed about the central shaft236and the second blade238B is a single blade extending radially from the central shaft236, wherein the first section240borders the second section242and the first blade238A is joined to the second blade238B at the border between the first section240and the second section242. In some examples, the first blade238A is helically disposed about the central shaft236with a variable pitch.

Referring now toFIG.10, in some examples, the first blade238A is helically disposed about the central shaft236and the second blade238B comprises a plurality of second blades238B, each of the second blades238B extending radially from the central shaft236and being disposed circumferentially about the central shaft236. Example adipose filtration modules200including the rotary implement230as shown inFIG.10are shown inFIG.52andFIG.53. In certain examples, the outlet204can be located at a 90° angle relative to the longitudinal axis of the rotary implement230, as shown inFIG.52.

In some examples, the adipose separation module200further comprises a rod244and wherein the central shaft236of the rotary implement230is disposed circumferentially around and coaxially with the rod244.

The rod244can comprise any suitable material, such as those known in the art. In some examples, the rod244can comprise a polymer, a composite material, a metal, or a combination thereof. In some examples, the rod244can comprise a metal, such as titanium, stainless steel, derivatives thereof, or combinations thereof.

Referring now toFIG.11, in some examples, the adipose separation module200further comprises a sliding ring224, the sliding ring224being slidably disposed between the rotary implement230and an inner surface of the filter210, such that the sliding ring224is disposed circumferentially around and coaxially with the rotary implement230and the inner surface of the filter210is disposed circumferentially around and coaxially with the sliding ring224. The sliding ring224can be configured, for example, to slide axially to clear the inner surface of the filter210.

The sliding ring244can be configured to be coupled to a means for axially sliding the sliding ring244.

The means for sliding the sliding ring244can be a manual means or an automated means. Examples of suitable means for sliding the sliding ring244include, but are not limited to, handles, actuators, magnetic coupling, and combinations thereof. In some examples, the means for sliding the sliding ring244can comprise an actuator coupled to the sliding ring224. In some examples, the kit further comprises the means for sliding the sliding ring244.

The sliding ring224can comprise any suitable material, such as those known in the art. In some examples, the sliding ring224can comprise a polymer, a composite material, a metal, or a combination thereof. In some examples, the sliding ring224can comprise a polymer, such as an acetal resin (e.g., Delrin®), polytetrafluoroethylene (PTFE), polyether ether ketone (PEEK), polycarbonate, acrylonitrile butadiene styrene (ABS), poly(methyl methacrylate) (PMMA), polyvinyl chloride (PVC), an acrylic (e.g., a polyacrylic), nylon, polyester, derivatives thereof, or combinations thereof. In some examples, the sliding ring224can comprise a magnetic material.

The sliding ring224has a longitudinal axis, a proximal end, and a distal end opposite and axially spaced apart from the proximal end. The sliding ring224has a length, the length being the dimension along the longitudinal axis from the proximal end to the distal end. The sliding ring224can have a length of 10 mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the sliding ring224can have a length of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, or 11 mm or less). The length of the sliding ring224can range from any of the minimum values described above to any of the maximum values described above. For example, the sliding ring224can have a length of from 10 mm to 50 mm (e.g., from 10 mm to 30 mm, from 30 mm to 50 mm, from 10 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 12 mm to 50 mm, from 10 mm to 48 mm, from 12 mm to 48 mm, from 10 mm to 25 mm, or from 10 mm to 15 mm).

The sliding ring224can, for example, have an outer diameter of 10 mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the sliding ring224can have an outer diameter of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, or 11 mm or less). The outer diameter of the sliding ring224can range from any of the minimum values described above to any of the maximum values described above. For example, the sliding ring224can have an outer diameter of from 10 mm to 50 mm (e.g., from 10 mm to 30 mm, from 30 mm to 50 mm, from 10 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 12 mm to 50 mm, from 10 mm to 48 mm, from 12 mm to 48 mm, from 10 mm to 25 mm, or from 10 mm to 15 mm).

Referring now toFIG.12, in some examples, the adipose separation module200is disposed on a platform226. The adipose separation module200can, for example, be attached to the platform226using adhesives, bolts, screws, clips, or any other mechanical or chemical fastener known in the art.

The platform226can comprise any suitable material, such as those known in the art. In some examples, the platform226can comprise a polymer, a composite material, a metal, or a combination thereof. In some examples, the platform226can comprise a polymer, such as polycarbonate, acrylonitrile butadiene styrene (ABS), poly(methyl methacrylate) (PMMA), polyvinyl chloride (PVC), an acrylic (e.g., a polyacrylic), nylon, polyester, polytetrafluoroethylene (PTFE), an acetal resin (e.g., Delrin®), polyether ether ketone (PEEK), derivatives thereof, or combinations thereof.

In some examples, the rotary implement230is configured to be coupled to a means for rotating228the rotary implement230, wherein the means for rotating228the rotary implement230is configured to rotate the rotary implement230within the first compartment212.

The means for rotating228the rotary implement230can comprise any suitable means, such as those known in the art. The means for rotating228the rotary implement can be a manual means or an automated means. Examples of suitable means for rotating228the rotary implement include, but are not limited to, cranks, motors, gears, and combinations thereof. In some examples, the means for rotating228the rotary implement230can comprise a motor, such as variable speed motor. In some examples, the kit100further comprises a means for rotating228the rotary implement230of the adipose separation module200.

For example, the means for rotating228the rotary implement230can comprise a variable speed motor, such as a gear motor with a controllable speed. For example, the motor228can have a speed of 2 RPM or more (e.g., 3 RPM or more, 4 RPM or more, 5 RPM or more, 6 RPM or more, 7 RPM or more, 8 RPM or more, 9 RPM or more, 10 RPM or more, 11 RPM or more, 12 RPM or more, 13 RPM or more, 14 RPM or more, 15 RPM or more, 16 RPM or more, 17 RPM or more, 18 RPM or more, 19 RPM or more, 20 RPM or more, 21 RPM or more, 22 RPM or more, 23 RPM or more, or 24 RPM or more). In some examples, the motor228can have a speed of 25 RPM or less (e.g., 24 RPM or less, 23 RPM or less, 22 RPM or less, 21 RPM or less, 20 RPM or less, 19 RPM or less, 18 RPM or less, 17 RPM or less, 16 RPM or less, 15 RPM or less, 14 RPM or less, 13 RPM or less, 12 RPM or less, 11 RPM or less, 10 RPM or less, 9 RPM or less, 8 RPM or less, 7 RPM or less, 6 RPM or less, 5 RPM or less, 4 RPM or less, or 3 RPM or less). The speed of the motor228can range from any of the minimum values described above to any of the maximum values described above. For example, the motor228can have a speed of from 2 RPM to 25 RPM (e.g., from 2 to 13 RPM, from 13 to 25 RPM, from 2 to 5 RPM, from 5 to 10 RPM, from 10 to 15 RPM, from 15 to 20 RPM, from 20 to 25 RPM, from 3 to 25 RPM, from 4 to 25 RPM, from 5 to 25 RPM, from 6 to 25 RPM, from 8 to 25 RPM, from 10 to 25 RPM, from 15 to 25 RPM, from 2 to 24 RPM, from 2 to 23 RPM, from 2 to 22 RPM, from 2 to 21 RPM, from 2 to 20 RPM, from 2 to 18 RPM, from 2 to 15 RPM, from 2 to 10 RPM, from 3 to 24 RPM, from 5 to 20 RPM, from 10 to 20 RPM, or from 15 to 20 RPM).

Referring now toFIG.13, in some examples, the means for rotating228the rotary implement230of the adipose separation module200comprises a gear pump disposed inside the housing206and coupled to the rotary implement230of the adipose separation module200. An example adipose filtration modules200including a gear pump is shown inFIG.51.

Referring now toFIG.14, in some examples, the means for rotating228the rotary implement230of the adipose separation module200comprises a motor disposed outside the housing206and coupled to the central shaft236and/or the rod244of the rotary implement230of the adipose separation module200.

In some examples, the adipose separation module200further comprises a port203, wherein the port230is defined by the housing206and is fluidly connected to the second compartment214, for example at or near the distal end of the second compartment214.

The port203can, for example, have an inner diameter of 1 mm or more (e.g., 1.5 mm or more, 2 mm or more, 2.5 mm or more, 3 mm or more, 3.5 mm or more, 4 mm or more, 4.5 mm or more, 5 mm or more, 5.5 mm or more, 6 mm or more, 6.5 mm or more, 7 mm or more, 7.5 mm or more, 8 mm or more, 8.5 mm or more, 9 mm or more, 9.5 mm or more, 10 mm or more, 10.5 mm or more, 11 mm or more, or 11.5 mm or more). In some examples, the port203can have an inner diameter of 12 mm or less (e.g., 11.5 mm or less, 11 mm or less, 10.5 mm or less, 10 mm or less, 9.5 mm or less, 9 mm or less, 8.5 mm or less, 8 mm or less, 7.5 mm or less, 7 mm or less, 6.5 mm or less, 6 mm or less, 5.5 mm or less, 5 mm or less, 4.5 mm or less, 4 mm or less, 3.5 mm or less, 3 mm or less, 2.5 mm or less, 2 mm or less, or 1.5 mm or less). The inner diameter of the port203can range from any of the minimum values described above to any of the maximum values described above. For example, the port203can have an inner diameter of from 1 mm to 12 mm (e.g., from 1 mm to 6 mm, from 6 mm to 12 mm, from 1 mm to 4 mm, from 4 mm to 8 mm, from 8 mm to 12 mm, from 2 mm to 12 mm, from 1 mm to 11 mm, or from 2 mm to 11 mm).

Referring now toFIG.15, in some examples, the port203of the adipose separation module200is configured to be fluidly connected to an effluent receptacle914, for example via a sixth tube916, the effluent receptacle914being configured to receive the effluent from the port203of the adipose separation module200.

For example, the port203of the adipose separation module200can be configured to be fluidly connected to the sixth tube916, wherein the sixth tube916is configured to fluidly connect the port203of the adipose separation module200to an effluent receptacle914. In some examples, the kit100further comprises an effluent receptacle914configured to be fluidly connected to the port203of the adipose separation module200. In some examples, the kit100further comprises a sixth tube916configured to fluidly connect the port203of the adipose separation module to an effluent receptacle914. In some examples, the kit100further comprises a sixth tube916and an effluent receptacle914, wherein the sixth tube916is configured to fluidly connect the port203of the adipose separation module200to the effluent receptacle914, the effluent receptacle914being configured to receive the effluent from the port203of the adipose separation module200.

The effluent receptacle914can, for example, comprise any suitable container for containing the effluent, such as those known in the art. In some examples, the effluent receptacle914can comprise a flexible polymer collection bag, vacutainer, or vacuum canister. In some examples, the effluent receptacle914can comprise a disposable medical collection bag. In some examples, the effluent receptacle914containing the effluent can be disposable as biohazard waste. The effluent receptacle914can, for example, comprise any suitable material, such as those known in the art. For example, the effluent receptacle914can comprise a polymer.

Referring now toFIG.16, in some examples, the kit100further comprises a seventh tube112and an effluent separation module300having an inlet302and an outlet304, wherein the seventh tube112is configured to fluidly connect the inlet302of the effluent separation module300to the port203of the adipose separation module200, the effluent separation module300being configured to receive the effluent from the port203of the adipose separation module200and separate a desired component from the effluent.

The inlet302of the effluent separation module300can, for example, have an inner diameter of 1 millimeter (mm) or more (e.g., 1.25 mm or more, 1.5 mm or more, 1.75 mm or more, 2 mm or more, 2.25 mm or more, 2.5 mm or more, 2.75 mm or more, 3 mm or more, 3.25 mm or more, 3.5 mm or more, 3.75 mm or more, 4 mm or more, 4.25 mm or more, 4.5 mm or more, 4.75 mm or more, 5 mm or more, 5.25 mm or more, 5.5 mm or more, or 5.75 mm or more). In some examples, the inlet302of the effluent separation module300can have an inner diameter of 6 mm or less (e.g., 5.75 mm or less, 5.5 mm or less, 5.25 mm or less, 5 mm or less, 4.75 mm or less, 4.5 mm or less, 4.25 mm or less, 4 mm or less, 3.75 mm or less, 3.5 mm or less, 3.25 mm or less, 3 mm or less, 2.75 mm or less, 2.5 mm or less, 2.25 mm or less, 2 mm or less, 1.75 mm or less, 1.5 mm or less, or 1.25 mm or less). The inner diameter of inlet302of the effluent separation module300can range from any of the minimum values described above to any of the maximum values described above. For example, the inlet302of the effluent separation module200can have an inner diameter of from 1 millimeter (mm) to 6 mm (e.g., from 1 mm to 3.5 mm, from 3.5 mm to 6 mm, from 1 mm to 2 mm, from 2 mm to 3 mm, from 3 mm to 4 mm, from 4 mm to 5 mm, from 5 mm to 6 mm, from 1 mm to 5.5 mm, from 1.5 mm to 5.5 mm, from 1.5 mm to 5.5 mm, from 2 mm to 6 mm, from 3 mm to 6 mm, from 4 mm to 6 mm, or from 5.25 mm to 5.5 mm).

The outlet304of the effluent separation module300can, for example, have an inner diameter of 1 millimeter (mm) or more (e.g., 1.25 mm or more, 1.5 mm or more, 1.75 mm or more, 2 mm or more, 2.25 mm or more, 2.5 mm or more, 2.75 mm or more, 3 mm or more, 3.25 mm or more, 3.5 mm or more, 3.75 mm or more, 4 mm or more, 4.25 mm or more, 4.5 mm or more, 4.75 mm or more, 5 mm or more, 5.25 mm or more, 5.5 mm or more, or 5.75 mm or more). In some examples, the outlet304of the effluent separation module200can have an inner diameter of 6 mm or less (e.g., 5.75 mm or less, 5.5 mm or less, 5.25 mm or less, 5 mm or less, 4.75 mm or less, 4.5 mm or less, 4.25 mm or less, 4 mm or less, 3.75 mm or less, 3.5 mm or less, 3.25 mm or less, 3 mm or less, 2.75 mm or less, 2.5 mm or less, 2.25 mm or less, 2 mm or less, 1.75 mm or less, 1.5 mm or less, or 1.25 mm or less). The inner diameter of outlet of the effluent separation module200can range from any of the minimum values described above to any of the maximum values described above. For example, the outlet204of the effluent separation module200can have an inner diameter of from 1 millimeter (mm) to 6 mm (e.g., from 1 mm to 3.5 mm, from 3.5 mm to 6 mm, from 1 mm to 2 mm, from 2 mm to 3 mm, from 3 mm to 4 mm, from 4 mm to 5 mm, from 5 mm to 6 mm, from 1 mm to 5.5 mm, from 1.5 mm to 5.5 mm, from 1.5 mm to 5.5 mm, from 2 mm to 6 mm, from 3 mm to 6 mm, from 4 mm to 6 mm, or from 5.25 mm to 5.5 mm).

In some examples, the effluent separation module300comprises a membrane filter, the membrane filter being configured to separate the desired component from other components in the effluent by passing the desired component through the membrane filter and blocking the passage of the other components through the membrane filter. The desired component can, for example, comprise platelets, plasma, platelet-rich plasma (PRP), stem cells, a protein, or a combination thereof.

Referring now toFIG.17, in some examples, the effluent separation module300further comprises: a housing306defining an interior cavity308, the inlet302, and the outlet304. In some examples, the effluent separation module300further comprises a filter310configured to be disposed within the interior cavity308, such that the filter310is configured to define a first compartment312and a second compartment314within the interior cavity308, the first compartment312being a portion of the interior cavity308encompassed by the filter310and the second compartment314being a portion of the interior cavity308outside the filter310; wherein the first compartment312has a proximal end316and a distal end318, the inlet302of the effluent separation module300being fluidly connected to the first compartment312at or near the proximal end316of the first compartment312, and the outlet304of the effluent separation module300being fluidly connected to the first compartment312at or near the distal end318of the first compartment312.

In some examples, the filter310is configured to separate the desired component from the other components in the effluent by passing the other components from the effluent through the filter310into the second compartment314as the effluent is transported through the housing306, thereby concentrating the desired component within the first compartment312and forming a waste solution in the second compartment314, the waste solution comprising the other components from the effluent. The desired component can, for example, comprise platelets, plasma, platelet-rich plasma (PRP), stem cells, a protein, or a combination thereof. In some examples, the desired component can be reintroduced to the concentrated adipose tissue. In some examples, the desired component can be used for a different medical procedure.

The housing306can comprise any suitable material, such as those known in the art. Examples of suitable materials for the housing306include, but are not limited to, polymers, such as transparent and semi-transparent polymers. In some examples, the housing306can comprise polycarbonate, acrylonitrile butadiene styrene (ABS), poly(methyl methacrylate) (PMMA), polyvinyl chloride (PVC), an acrylic (e.g., a polyacrylic), nylon, polyester, polytetrafluoroethylene (PTFE), an acetal resin (e.g., Delrin®), polyether ether ketone (PEEK), derivatives thereof, or combinations thereof. In some examples, the housing306can comprise polycarbonate.

The housing306can have any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. For example, the housing306can be a polyhedron (e.g., a platonic solid, a prism, a pyramid), a cylinder, a hemicylinder, an elliptical cylinder, a hemi-elliptical cylinder, a cone, a semicone, etc. In some examples, the housing306can have a cylindrical shape.

The housing306has a longitudinal axis, a proximal end, and a distal end opposite and axially spaced apart from the proximal end. The housing306has a length, the length being the dimension along the longitudinal axis from the proximal end to the distal end (e.g., “L” inFIG.17). In some examples, the housing306has a length of 50 mm or more (e.g., 55 mm or more, 60 mm or more, 65 mm or more, 70 mm or more, 75 mm or more, 80 mm or more, 85 mm or more, 90 mm or more, 95 mm or more, 100 mm or more, 110 mm or more, 120 mm or more, 130 mm or more, 140 mm or more, 150 mm or more, 160 mm or more, 170 mm or more, 180 mm or more, or 190 mm or more). In some example, the housing306has a length of 200 mm or less (e.g., 190 mm or less, 180 mm or less, 170 mm or less, 160 mm or less, 150 mm or less, 140 mm or less, 130 mm or less, 120 mm or less, 110 mm or less, 100 mm or less, 95 mm or less, 90 mm or less, 85 mm or less, 80 mm or less, 75 mm or less, 70 mm or less, 65 mm or less, 60 mm or less, or 55 mm or less). The length of the housing306can range from any of the minimum values described above to any of the maximum values described above. For example, the housing306can have a length of from 50 mm to 200 mm (e.g., from 50 mm to 125 mm, from 125 mm to 200 mm, from 50 mm to 100 mm, from 100 mm to 150 mm, from 150 mm to 200 mm, from 50 mm to 175 mm, from 75 mm to 200 mm, from 75 mm to 174 mm, from 50 mm to 150 mm, from 60 mm to 90 mm, from 70 mm to 80 mm, or from 75 mm to 80 mm). In some examples, the housing306can have a length of from 75 mm to 80 mm.

The housing306can have a cross-sectional shape in a plane perpendicular to the longitudinal axis, wherein the cross-sectional shape can be any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. In some examples, the cross-sectional shape of the housing306can be substantially circular, ovate, ovoid, elliptic, triangular, rectangular, polygonal, etc.

The housing306can have an average characteristic dimension. The term “characteristic dimension,” as used herein refers to the largest straight line distance between two points in the plane of the cross-sectional shape of the housing306. “Average characteristic dimension” and “mean characteristic dimension” are used interchangeably herein, and generally refer to the statistical mean characteristic dimension. For example, for a cylindrical housing306, the cross-sectional shape can be substantially circular and the average characteristic dimension can refer to the average diameter.

For example, the housing306can have an average characteristic dimension of 15 mm or more (e.g., 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 26 mm or more, 27 mm or more, 28 mm or more, 29 mm or more, 30 mm or more, 31 mm or more, 32 mm or more, 33 mm or more, 34 mm or more, 35 mm or more, 36 mm or more, 37 mm or more, 38 mm or more, 39 mm or more, 40 mm or more, 45 mm or more, 50 mm or more, 55 mm or more, 60 mm or more, 65 mm or more, or 70 mm or more). In some examples, the housing306can have an average characteristic dimension of 75 mm or less (e.g., 70 mm or less, 65 mm or less, 60 mm or less, 55 mm or less, 50 mm or less, 45 mm or less, 40 mm or less, 39 mm or less, 38 mm or less, 37 mm or less, 36 mm or less, 35 mm or less, 34 mm or less, 33 mm or less, 32 mm or less, 31 mm or less, 30 mm or less, 29 mm or less, 28 mm or less, 27 mm or less, 26 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, or 16 mm or less). The average characteristic dimension of the housing306can range from any of the minimum values described above to any of the maximum values described above. For example, the housing306can have an average characteristic dimension of from 15 mm to 75 mm (e.g., from 15 mm to 45 mm, from 45 mm to 75 mm, from 15 mm to 35 mm, from 35 mm to 55 mm, from 55 mm to 75 mm, from 15 mm to 70 mm, from 20 mm to 75 mm, from 20 mm to 70 mm, from 20 mm to 40 mm, or from 30 mm to 36 mm).

The interior cavity308can have any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. For example, the interior cavity308can be a polyhedron (e.g., a platonic solid, a prism, a pyramid), a cylinder, a hemicylinder, an elliptical cylinder, a hemi-elliptical cylinder, a cone, a semicone, etc. In some examples, the interior cavity308can have a cylindrical shape.

The interior cavity308has a longitudinal axis, a proximal end, and a distal end opposite and axially spaced apart from the proximal end. The interior cavity308has a length, the length being the dimension along the longitudinal axis from the proximal end to the distal end. The interior cavity308can have a length of 25 mm or more (e.g., 30 mm or more, 35 mm or more, 40 mm or more, 45 mm or more, 50 mm or more, 55 mm or more, 60 mm or more, 65 mm or more, 70 mm or more, 75 mm or more, 80 mm or more, 85 mm or more, 90 mm or more, 95 mm or more, 100 mm or more, 105 mm or more, 110 mm or more, 115 mm or more, 120 mm or more, 125 mm or more, 130 mm or more, 135 mm or more, 140 mm or more, or 145 mm or more). In some examples, the interior cavity308can have a length of 150 mm or less (e.g., 145 mm or less, 140 mm or less, 135 mm or less, 130 mm or less, 125 mm or less, 120 mm or less, 115 mm or less, 110 mm or less, 105 mm or less, 100 mm or less, 95 mm or less, 90 mm or less, 85 mm or less, 80 mm or less, 75 mm or less, 70 mm or less, 65 mm or less, 60 mm or less, 55 mm or less, 50 mm or less, 45 mm or less, 40 mm or less, 35 mm or less, or 30 mm or less). The length of the interior cavity308can range from any of the minimum values described above to any of the maximum values described above. For example, the interior cavity308can have an length of from 25 mm to 150 mm (e.g., from 25 mm to 90 mm, from 90 mm to 150 mm, from 25 mm to 50 mm, from 50 mm to 75 mm, from 75 mm to 100 mm, from 100 mm to 125 mm, from 125 mm to 150 mm, from 30 mm to 150 mm, from 25 mm to 145 mm, from 30 mm to 145 mm, from 30 mm to 75 mm, or from 60 mm to 70 mm).

The interior cavity308can have a cross-sectional shape in a plane perpendicular to the longitudinal axis, wherein the cross-sectional shape can be any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. In some examples, the cross-sectional shape of the interior cavity308can be substantially circular, ovate, ovoid, elliptic, triangular, rectangular, polygonal, etc.

The interior cavity308can have an average characteristic dimension. The term “characteristic dimension,” as used herein refers to the largest straight line distance between two points in the plane of the cross-sectional shape of the interior cavity308. “Average characteristic dimension” and “mean characteristic dimension” are used interchangeably herein, and generally refer to the statistical mean characteristic dimension. For example, for a cylindrical interior cavity308, the cross-sectional shape can be substantially circular and the average characteristic dimension can refer to the average diameter.

For example, the interior cavity308can have an average characteristic dimension of 5 mm or more (e.g., 6 mm or more, 7 mm or more, 8 mm or more, 9 mm or more, 10 mm or more, 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the interior cavity308has an average characteristic dimension of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, 11 mm or less, 10 mm or less, 9 mm or less, 8 mm or less, 7 mm or less, or 6 mm or less). The average characteristic dimension of the interior cavity308can range from any of the minimum values described above to any of the maximum values described above. For example, the interior cavity308can have an average characteristic dimension of from 5 mm to 50 mm (e.g., from 5 mm to 30 mm, from 30 mm to 50 mm, from 5 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 10 mm to 50 mm, from 5 mm to 48 mm, from 10 mm to 48 mm, from 10 mm to 25 mm, or from 15 mm to 23 mm).

The first compartment312can have any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. For example, the first compartment312can be a polyhedron (e.g., a platonic solid, a prism, a pyramid), a cylinder, a hemicylinder, an elliptical cylinder, a hemi-elliptical cylinder, a cone, a semicone, etc. In some examples, the first compartment312can have a cylindrical shape.

In some examples, the first compartment312is disposed coaxially with the filter310.

The first compartment312has a longitudinal axis, with the proximal end316being opposite and axially spaced apart from the distal end318. The first compartment312has a length, the length being the dimension along the longitudinal axis from the proximal end316to the distal end318. The first compartment312can, for example, have a length of 25 mm or more (e.g., 30 mm or more, 35 mm or more, 40 mm or more, 45 mm or more, 50 mm or more, 55 mm or more, 60 mm or more, 65 mm or more, 70 mm or more, 75 mm or more, 80 mm or more, 85 mm or more, 90 mm or more, 95 mm or more, 100 mm or more, 105 mm or more, 110 mm or more, 115 mm or more, 120 mm or more, 125 mm or more, 130 mm or more, 135 mm or more, 140 mm or more, or 145 mm or more). In some examples, the first compartment312can have a length of 150 mm or less (e.g., 145 mm or less, 140 mm or less, 135 mm or less, 130 mm or less, 125 mm or less, 120 mm or less, 115 mm or less, 110 mm or less, 105 mm or less, 100 mm or less, 95 mm or less, 90 mm or less, 85 mm or less, 80 mm or less, 75 mm or less, 70 mm or less, 65 mm or less, 60 mm or less, 55 mm or less, 50 mm or less, 45 mm or less, 40 mm or less, 35 mm or less, or 30 mm or less). The length of the first compartment312can range from any of the minimum values described above to any of the maximum values described above. For example, the first compartment312can have a length of from 25 mm to 150 mm (e.g., from 25 mm to 90 mm, from 90 mm to 150 mm, from 25 mm to 50 mm, from 50 mm to 75 mm, from 75 mm to 100 mm, from 100 mm to 125 mm, from 125 mm to 150 mm, from 25 mm to 140 mm, from 35 mm to 150 mm, from 35 mm to 140 mm, from 60 mm to 75 mm, or from 60 mm to 70 mm).

The first compartment312can have a cross-sectional shape in a plane perpendicular to the longitudinal axis, wherein the cross-sectional shape can be any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. In some examples, the cross-sectional shape of the first compartment312can be substantially circular, ovate, ovoid, elliptic, triangular, rectangular, polygonal, etc.

The first compartment312can have an average characteristic dimension. The term “characteristic dimension,” as used herein refers to the largest straight line distance between two points in the plane of the cross-sectional shape of the first compartment312. “Average characteristic dimension” and “mean characteristic dimension” are used interchangeably herein, and generally refer to the statistical mean characteristic dimension. For example, for a cylindrical first compartment312, the cross-sectional shape can be substantially circular and the average characteristic dimension can refer to the average diameter.

For example, the first compartment312can have an average characteristic dimension of 10 mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the first compartment312has an average characteristic dimension of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, or 11 mm or less). The average characteristic dimension of the first compartment312can range from any of the minimum values described above to any of the maximum values described above. For example, the first compartment312can have an average characteristic dimension of from 10 mm to 50 mm (e.g., from 10 mm to 30 mm, from 30 mm to 50 mm, from 10 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 12 mm to 50 mm, from 10 mm to 48 mm, from 12 mm to 48 mm, from 10 mm to 25 mm, or from 12 mm to 19 mm).

The filter310can comprise any suitable material, such as those known in the art. In some examples, the filter310can comprise a polymer, a composite material, a metal, or a combination thereof. In some examples, the filter310can comprise a polymer, such as nylon, polyester, polytetrafluoroethylene (PTFE), an acetal resin (e.g., Delrin®), polyether ether ketone (PEEK), derivatives thereof, or combinations thereof. In some examples, the filter310can comprise a metal, such as titanium, stainless steel, derivatives thereof, or combinations thereof. The filter310can, in some example, be different than the filter210. For example, the filter310can be selected to separate the desired component from the effluent.

In some examples, the filter310comprises a mesh filter. The mesh filter310can comprise a mesh with a plurality of openings. The plurality of openings of the filter310can, for example, have an average size of 5 micrometers (microns, μm) or more (e.g., 6 μm or more, 7 μm or more, 8 μm or more, 9 μm or more, 10 μm or more, 11 μm or more, 12 μm or more, 13 μm or more, 14 μm or more, 15 μm or more, 16 μm or more, 17 μm or more, 18 μm or more, or 19 μm or more). In some examples, the plurality of openings of the filter310can have an average size of 20 μm or less (e.g., 19 μm or less, 18 μm or less, 17 μm or less, 16 μm or less, 15 μm or less, 14 μm or less, 13 μm or less, 12 μm or less, 11 μm or less, 10 μm or less, 9 μm or less, 8 μm or less, 7 μm or less, or 6 μm or less). The average size of the plurality of openings of the filter310can range from any of the minimum values described above to any of the maximum values described above. For example, the plurality of openings of the filter310can have an average size of from 5 μm to 20 μm (e.g., from 5 μm to 12.5 μm, from 12.5 μm to 20 μm, from 5 μm to 10 μm, from 10 μm to 15 μm, from 15 μm to 20 μm, from 6 μm to 20 μm, from 5 μm to 19 μm, or from 6 μm to 19 μm). The average size of the plurality of openings can, for example, be selected to optimize cleaning and concentration of the desired component.

The filter310can have any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. For example, the filter310can be a polyhedron (e.g., a platonic solid, a prism, a pyramid), a cylinder, a hemicylinder, an elliptical cylinder, a hemi-elliptical cylinder, a cone, a semicone, etc. In some examples, the filter310can have a cylindrical shape.

The filter310has a longitudinal axis, a proximal end, and a distal end opposite and axially spaced apart from the proximal end. The filter310has a length, the length being the dimension along the longitudinal axis from the proximal end to the distal end.

The filter310can, for example, have a length of 25 mm or more (e.g., 30 mm or more, 35 mm or more, 40 mm or more, 45 mm or more, 50 mm or more, 55 mm or more, 60 mm or more, 65 mm or more, 70 mm or more, 75 mm or more, 80 mm or more, 85 mm or more, 90 mm or more, 95 mm or more, 100 mm or more, 105 mm or more, 110 mm or more, 115 mm or more, 120 mm or more, 125 mm or more, 130 mm or more, 135 mm or more, 140 mm or more, or 145 mm or more). In some examples, the filter310can have a length of 150 mm or less (e.g., 145 mm or less, 140 mm or less, 135 mm or less, 130 mm or less, 125 mm or less, 120 mm or less, 115 mm or less, 110 mm or less, 105 mm or less, 100 mm or less, 95 mm or less, 90 mm or less, 85 mm or less, 80 mm or less, 75 mm or less, 70 mm or less, 65 mm or less, 60 mm or less, 55 mm or less, 50 mm or less, 45 mm or less, 40 mm or less, 35 mm or less, or 30 mm or less). The length of the filter310can range from any of the minimum values described above to any of the maximum values described above. For example, the filter310can have a length of from 25 mm to 150 mm (e.g., from 25 mm to 90 mm, from 90 mm to 150 mm, from 25 mm to 50 mm, from 50 mm to 75 mm, from 75 mm to 100 mm, from 100 mm to 125 mm, from 125 mm to 150 mm, from 25 mm to 140 mm, from 35 mm to 150 mm, from 35 mm to 140 mm, from 40 mm to 60 mm, or from 48 mm to 56 mm). For example, the length of the filter310can be selected in view of the length of the interior cavity308.

The filter310can have a cross-sectional shape in a plane perpendicular to the longitudinal axis, wherein the cross-sectional shape can be any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. In some examples, the cross-sectional shape of the filter310can be substantially circular, ovate, ovoid, elliptic, triangular, rectangular, polygonal, etc.

The filter310can have an average characteristic dimension. The term “characteristic dimension,” as used herein refers to the largest straight line distance between two points in the plane of the cross-sectional shape of the filter310. “Average characteristic dimension” and “mean characteristic dimension” are used interchangeably herein, and generally refer to the statistical mean characteristic dimension. For example, for a cylindrical filter310, the cross-sectional shape can be substantially circular and the average characteristic dimension can refer to the average diameter.

For example, the filter310can have an average characteristic dimension of 10 mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the filter310has an average characteristic dimension of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, or 11 mm or less). The average characteristic dimension of the filter310can range from any of the minimum values described above to any of the maximum values described above. For example, the filter310can have an average characteristic dimension of from 10 mm to 50 mm (e.g., from 10 mm to 30 mm, from 30 mm to 50 mm, from 10 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 12 mm to 50 mm, from 10 mm to 48 mm, from 12 mm to 48 mm, from 10 mm to 25 mm, or from 12 mm to 19 mm). The average characteristic dimension of the filter310can, for example, be selected in view of the average characteristic dimension of the interior cavity308.

Referring now toFIG.18, in some examples, the effluent separation module300further comprises a filter cage322disposed circumferentially around and coaxially with the filter310within the interior cavity308. The filter cage322can, for example, provide structural support and/or rigidity to the filter310.

The filter cage322can comprise any suitable material, such as those known in the art. In some examples, the filter cage322can comprise a polymer, a composite material, a metal, or a combination thereof.

The filter cage322can have any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. For example, the filter cage322can be a polyhedron (e.g., a platonic solid, a prism, a pyramid), a cylinder, a hemicylinder, an elliptical cylinder, a hemi-elliptical cylinder, a cone, a semicone, etc. In some examples, the filter cage322can have a cylindrical shape. The shape of the filter case322can be selected, for example, in view of the shape of the filter310and/or the interior cavity308.

The filter cage322has a longitudinal axis, a proximal end, and a distal end opposite and axially spaced apart from the proximal end. The filter cage322has a length, the length being the dimension along the longitudinal axis from the proximal end to the distal end.

The filter cage322can, for example, have a length of 25 mm or more (e.g., 30 mm or more, 35 mm or more, 40 mm or more, 45 mm or more, 50 mm or more, 55 mm or more, 60 mm or more, 65 mm or more, 70 mm or more, 75 mm or more, 80 mm or more, 85 mm or more, 90 mm or more, 95 mm or more, 100 mm or more, 105 mm or more, 110 mm or more, 115 mm or more, 120 mm or more, 125 mm or more, 130 mm or more, 135 mm or more, 140 mm or more, or 145 mm or more). In some examples, the filter cage322can have a length of 150 mm or less (e.g., 145 mm or less, 140 mm or less, 135 mm or less, 130 mm or less, 125 mm or less, 120 mm or less, 115 mm or less, 110 mm or less, 105 mm or less, 100 mm or less, 95 mm or less, 90 mm or less, 85 mm or less, 80 mm or less, 75 mm or less, 70 mm or less, 65 mm or less, 60 mm or less, 55 mm or less, 50 mm or less, 45 mm or less, 40 mm or less, 35 mm or less, or 30 mm or less). The length of the filter can range from any of the minimum values described above to any of the maximum values described above. For example, the filter cage322can have a length of from 25 mm to 150 mm (e.g., from 25 mm to 90 mm, from 90 mm to 150 mm, from 25 mm to 50 mm, from 50 mm to 75 mm, from 75 mm to 100 mm, from 100 mm to 125 mm, from 125 mm to 150 mm, from 25 mm to 140 mm, from 35 mm to 150 mm, from 35 mm to 140 mm, from 40 mm to 60 mm, or from 48 mm to 56 mm). The length of the filter case322can be selected, for example, in view of the length of the filter310and/or the interior cavity308.

The filter cage322can have a cross-sectional shape in a plane perpendicular to the longitudinal axis, wherein the cross-sectional shape can be any shape, such as a regular shape, an irregular shape, an isotropic shape, or an anisotropic shape. In some examples, the cross-sectional shape of the filter cage322can be substantially circular, ovate, ovoid, elliptic, triangular, rectangular, polygonal, etc.

The filter cage322can have an average characteristic dimension. The term “characteristic dimension,” as used herein refers to the largest straight line distance between two points in the plane of the cross-sectional shape of the filter cage322. “Average characteristic dimension” and “mean characteristic dimension” are used interchangeably herein, and generally refer to the statistical mean characteristic dimension. For example, for a cylindrical filter cage322, the cross-sectional shape can be substantially circular and the average characteristic dimension can refer to the average diameter.

For example, the filter cage322can have an average characteristic dimension of 10 mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the filter cage322has an average characteristic dimension of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, or 11 mm or less). The average characteristic dimension of the filter cage322can range from any of the minimum values described above to any of the maximum values described above. For example, the filter cage322can have an average characteristic dimension of from 10 mm to 50 mm (e.g., from 10 mm to 30 mm, from 30 mm to 50 mm, from 10 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 12 mm to 50 mm, from 10 mm to 48 mm, from 12 mm to 48 mm, from 10 mm to 25 mm, or from 12 mm to 19 mm). The average characteristic dimension of the filter cage322can be selected, for example, in view of the average characteristic dimension of the filter310and/or the interior cavity308.

Referring now toFIG.19, in some examples, the effluent separation module300further comprises: a rotary implement330having longitudinal axis, a proximal end332, and a distal end334axially spaced apart from the proximal end, the rotary implement330comprising a central shaft336and a blade338extending from the central shaft336; wherein the filter is configured to be disposed circumferentially around and coaxially with the rotary implement330within the interior cavity308, such that the rotary implement330is configured to be rotatably disposed within the first compartment312with the proximal end332of the rotary implement330disposed towards the proximal end316of the first compartment312and the distal end334of the rotary implement330being disposed towards the distal end318of the first compartment312; and wherein the rotary implement330is configured to agitate the effluent within the first compartment312via rotation of the rotary implement330.

The rotary implement330can comprise any suitable material, such as those known in the art. In some examples, the rotary implement330can comprise a polymer, a composite material, a metal, or a combination thereof. In some examples, the rotary implement330can comprise polycarbonate, acrylonitrile butadiene styrene (ABS), poly(methyl methacrylate) (PMMA), polyvinyl chloride (PVC), an acrylic (e.g., a polyacrylic), nylon, polyester, polytetrafluoroethylene (PTFE), an acetal resin (e.g., Delrin®), polyether ether ketone (PEEK), derivatives thereof, or combinations thereof. In some examples, the rotary implement330can comprise polycarbonate. In some examples, the rotary implement330can comprise a metal, such as titanium, stainless steel, derivatives thereof, or combinations thereof.

The rotary implement330has a length, the length being the dimension along the longitudinal axis from the proximal end to the distal end. The rotary implement330can, for example, have a length of 25 mm or more (e.g., 30 mm or more, 35 mm or more, 40 mm or more, 45 mm or more, 50 mm or more, 55 mm or more, 60 mm or more, 65 mm or more, 70 mm or more, 75 mm or more, 80 mm or more, 85 mm or more, 90 mm or more, 95 mm or more, 100 mm or more, 105 mm or more, 110 mm or more, 115 mm or more, 120 mm or more, 125 mm or more, 130 mm or more, 135 mm or more, 140 mm or more, or 145 mm or more). In some examples, the rotary implement330can have a length of 150 mm or less (e.g., 145 mm or less, 140 mm or less, 135 mm or less, 130 mm or less, 125 mm or less, 120 mm or less, 115 mm or less, 110 mm or less, 105 mm or less, 100 mm or less, 95 mm or less, 90 mm or less, 85 mm or less, 80 mm or less, 75 mm or less, 70 mm or less, 65 mm or less, 60 mm or less, 55 mm or less, 50 mm or less, 45 mm or less, 40 mm or less, 35 mm or less, or 30 mm or less). The length of the rotary implement230can range from any of the minimum values described above to any of the maximum values described above. For example, the rotary implement230can have a length of from 25 mm to 150 mm (e.g., from 25 mm to 90 mm, from 90 mm to 150 mm, from 25 mm to 50 mm, from 50 mm to 75 mm, from 75 mm to 100 mm, from 100 mm to 125 mm, from 125 mm to 150 mm, from 25 mm to 140 mm, from 35 mm to 150 mm, from 35 mm to 140 mm, from 40 mm to 60 mm, or from 48 mm to 56 mm). The length of the rotary implement330can be selected, for example, in view of the length of the filter310and/or the interior cavity308.

For example, the central shaft336of the rotary implement330can have a diameter of 10 mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the central shaft336of the rotary implement330can have a diameter of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, or 11 mm or less). The diameter of the central shaft336of the rotary implement330can range from any of the minimum values described above to any of the maximum values described above. For example, the central shaft336of the rotary implement330can have a diameter of from 10 mm to 50 mm (e.g., from 10 mm to 30 mm, from 30 mm to 50 mm, from 10 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 12 mm to 50 mm, from 10 mm to 48 mm, from 12 mm to 48 mm, from 10 mm to 25 mm, or from 12 mm to 19 mm).

The rotary implement330has an outer diameter as measured to the edge of the blade338(e.g., edge to edge for a helical blade338). For example, the rotary implement330can have an outer diameter of 5 mm or more (e.g., 6 mm or more, 7 mm or more, 8 mm or more, 9 mm or more, 10 mm or more, 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the rotary implement330can have an outer diameter of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, 11 mm or less, 10 mm or less, 9 mm or less, 8 mm or less, 7 mm or less, or 6 mm or less). The outer diameter of the rotary implement330can range from any of the minimum values described above to any of the maximum values described above. For example, the rotary implement330can have an outer diameter of from 5 mm to 50 mm (e.g., from 5 mm to 30 mm, from 30 mm to 50 mm, from 5 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 10 mm to 50 mm, from 5 mm to 48 mm, from 10 mm to 48 mm, from 10 mm to 25 mm, or from 10 mm to 15 mm).

The rotary implement330can have any suitable configuration. Example rotary implements330are shown inFIG.20toFIG.24.

In some examples, the blade338is helically disposed about the central shaft236.

Referring now toFIG.20, in some examples, the blade338is helically disposed about the central shaft336with a variable pitch.

Referring now toFIG.21, in some examples, the blade338comprises a plurality of blades338, each of the blades338extending radially from the central shaft336and being disposed circumferentially about the central shaft336.

In some examples, the rotary implement330comprises a first section340and a second section342, the first section340extending along a first portion of the central shaft336towards the proximal end332of the rotary implement330and the second section342being adjacent the first section and extending along a second portion of the central shaft336, wherein the first section340has a first blade338A extending from the central shaft336and the second section342has a second blade338B extending from the central shaft336.

Referring now toFIG.22, in some examples, the second blade338B is helically disposed about the central shaft336and the first blade338A comprises a plurality of first blades338A, each of the first blades338A extending radially from the central shaft336and being disposed circumferentially about the central shaft336.

Referring now toFIG.23, in some examples, the first blade338A is helically disposed about the central shaft336and the second blade338B is a single blade extending radially from the central shaft336, wherein the first section340borders the second section342and the first blade338A is joined to the second blade338B at the border between the first section340and the second section342. In some examples, the first blade338A is helically disposed about the central shaft336with a variable pitch.

Referring now toFIG.24, in some examples, the first blade338A is helically disposed about the central shaft336and the second blade338B comprises a plurality of second blades338B, each of the second blades338B extending radially from the central shaft336and being disposed circumferentially about the central shaft336.

In some examples, the effluent separation module300further comprises a rod344and wherein the central shaft336of the rotary implement330is disposed circumferentially around and coaxially with the rod344.

The rod344can comprise any suitable material, such as those known in the art. In some examples, the rod344can comprise a polymer, a composite material, a metal, or a combination thereof. In some examples, the rod344can comprise a metal, such as titanium, stainless steel, derivatives thereof, or combinations thereof.

Referring now toFIG.25, in some examples, the effluent separation module300further comprises a sliding ring324, the sliding ring324being slidably disposed between the rotary implement330and an inner surface of the filter310, such that the sliding ring324is disposed circumferentially around and coaxially with the rotary implement330and the inner surface of the filter310is disposed circumferentially around and coaxially with the sliding ring324. The sliding ring324can be configured, for example, to slide axially to clear the inner surface of the filter310.

The sliding ring344can be configured to be coupled to a means for axially sliding the sliding ring344. The means for sliding the sliding ring344can be a manual means or an automated means. Examples of suitable means for sliding the sliding ring344include, but are not limited to, handles, actuators, magnetic coupling, and combinations thereof. In some examples, the means for sliding the sliding ring344can comprise an actuator coupled to the sliding ring324. In some examples, the kit further comprises the means for sliding the sliding ring344.

The sliding ring324can comprise any suitable material, such as those known in the art. In some examples, the sliding ring324can comprise a polymer, a composite material, a metal, or a combination thereof. In some examples, the sliding ring324can comprise a polymer, such as polycarbonate, acrylonitrile butadiene styrene (ABS), poly(methyl methacrylate) (PMMA), polyvinyl chloride (PVC), an acrylic (e.g., a polyacrylic), nylon, polyester, polytetrafluoroethylene (PTFE), an acetal resin (e.g., Delrin®), polyether ether ketone (PEEK), derivatives thereof, or combinations thereof. In some examples, the sliding ring324can comprise a magnetic material.

The sliding ring324has a longitudinal axis, a proximal end, and a distal end opposite and axially spaced apart from the proximal end. The sliding ring324has a length, the length being the dimension along the longitudinal axis from the proximal end to the distal end. The sliding ring324can have a length of 10 mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the sliding ring324can have a length of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, or 11 mm or less). The length of the sliding ring324can range from any of the minimum values described above to any of the maximum values described above. For example, the sliding ring324can have a length of from 10 mm to 50 mm (e.g., from 10 mm to 30 mm, from 30 mm to 50 mm, from 10 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 12 mm to 50 mm, from 10 mm to 48 mm, from 12 mm to 48 mm, from 10 mm to 25 mm, or from 10 mm to 15 mm).

The sliding ring324can, for example, have an outer diameter of 10 mm or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 30 mm or more, 35 mm or more, 40 mm or more, or 45 mm or more). In some examples, the sliding ring324can have an outer diameter of 50 mm or less (e.g., 45 mm or less, 40 mm or less, 35 mm or less, 30 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, or 11 mm or less). The outer diameter of the sliding ring324can range from any of the minimum values described above to any of the maximum values described above. For example, the sliding ring324can have an outer diameter of from 10 mm to 50 mm (e.g., from 10 mm to 30 mm, from 30 mm to 50 mm, from 10 mm to 20 mm, from 20 mm to 30 mm, from 30 mm to 40 mm, from 40 mm to 50 mm, from 12 mm to 50 mm, from 10 mm to 48 mm, from 12 mm to 48 mm, from 10 mm to 25 mm, or from 10 mm to 15 mm).

Referring now toFIG.26, in some examples, the effluent separation module300is disposed on a platform326. The effluent separation module300can, for example, be attached to the platform326using adhesives, bolts, screws, clips, or any other mechanical or chemical fastener known in the art.

The platform326can comprise any suitable material, such as those known in the art. In some examples, the platform326can comprise a polymer, a composite material, a metal, or a combination thereof. In some examples, the platform326can comprise a polymer, such as polycarbonate, acrylonitrile butadiene styrene (ABS), poly(methyl methacrylate) (PMMA), polyvinyl chloride (PVC), an acrylic (e.g., a polyacrylic), nylon, polyester, polytetrafluoroethylene (PTFE), an acetal resin (e.g., Delrin®), polyether ether ketone (PEEK), derivatives thereof, or combinations thereof.

In some examples, the rotary implement330is configured to be coupled to a means for rotating328the rotary implement330, wherein the means for rotating328the rotary implement330is configured to rotate the rotary implement330within the first compartment312.

The means for rotating328the rotary implement330can comprise any suitable means, such as those known in the art. The means for rotating328the rotary implement can be a manual means or an automated means. Examples of suitable means for rotating328the rotary implement include, but are not limited to, cranks, motors, gears, and combinations thereof. In some examples, the means for rotating328the rotary implement330can comprise a motor, such as variable speed motor. In some examples, the kit100further comprises a means for rotating328the rotary implement330of the effluent separation module300.

For example, the means for rotating328the rotary implement330can comprise a variable speed motor, such as a gear motor with a controllable speed. For example, the motor328can have a speed of 2 RPM or more (e.g., 3 RPM or more, 4 RPM or more, 5 RPM or more, 6 RPM or more, 7 RPM or more, 8 RPM or more, 9 RPM or more, 10 RPM or more, 11 RPM or more, 12 RPM or more, 13 RPM or more, 14 RPM or more, 15 RPM or more, 16 RPM or more, 17 RPM or more, 18 RPM or more, 19 RPM or more, 20 RPM or more, 21 RPM or more, 22 RPM or more, 23 RPM or more, or 24 RPM or more). In some examples, the motor328can have a speed of 25 RPM or less (e.g., 24 RPM or less, 23 RPM or less, 22 RPM or less, 21 RPM or less, 20 RPM or less, 19 RPM or less, 18 RPM or less, 17 RPM or less, 16 RPM or less, 15 RPM or less, 14 RPM or less, 13 RPM or less, 12 RPM or less, 11 RPM or less, 10 RPM or less, 9 RPM or less, 8 RPM or less, 7 RPM or less, 6 RPM or less, 5 RPM or less, 4 RPM or less, or 3 RPM or less). The speed of the motor228can range from any of the minimum values described above to any of the maximum values described above. For example, the motor328can have a speed of from 2 RPM to 25 RPM (e.g., from 2 to 13 RPM, from 13 to 25 RPM, from 2 to 5 RPM, from 5 to 10 RPM, from 10 to 15 RPM, from 15 to 20 RPM, from 20 to 25 RPM, from 3 to 25 RPM, from 4 to 25 RPM, from 5 to 25 RPM, from 6 to 25 RPM, from 8 to 25 RPM, from to 25 RPM, from 15 to 25 RPM, from 2 to 24 RPM, from 2 to 23 RPM, from 2 to 22 RPM, from 2 to 21 RPM, from 2 to 20 RPM, from 2 to 18 RPM, from 2 to 15 RPM, from 2 to 10 RPM, from 3 to 24 RPM, from 5 to 20 RPM, from 10 to 20 RPM, or from 15 to 20 RPM).

Referring now toFIG.27, in some examples, the means for rotating328the rotary implement330of the effluent separation module300comprises a gear pump disposed inside the housing306and coupled to the rotary implement330of the effluent separation module300.

Referring now toFIG.28, in some examples, the means for rotating328the rotary implement330of the effluent separation module300comprises a motor disposed outside the housing306and coupled to the central shaft336and/or the rod344of the rotary implement330of the effluent separation module300.

In some examples, the effluent separation module300further comprises a port303, wherein the port330is defined by the housing306and is fluidly connected to the second compartment314, for example at or near the distal end of the second compartment314.

The port303can, for example, have an inner diameter of 1 mm or more (e.g., 1.5 mm or more, 2 mm or more, 2.5 mm or more, 3 mm or more, 3.5 mm or more, 4 mm or more, 4.5 mm or more, 5 mm or more, 5.5 mm or more, 6 mm or more, 6.5 mm or more, 7 mm or more, 7.5 mm or more, 8 mm or more, 8.5 mm or more, 9 mm or more, 9.5 mm or more, 10 mm or more, 10.5 mm or more, 11 mm or more, or 11.5 mm or more). In some examples, the port303can have an inner diameter of 12 mm or less (e.g., 11.5 mm or less, 11 mm or less, 10.5 mm or less, 10 mm or less, 9.5 mm or less, 9 mm or less, 8.5 mm or less, 8 mm or less, 7.5 mm or less, 7 mm or less, 6.5 mm or less, 6 mm or less, 5.5 mm or less, 5 mm or less, 4.5 mm or less, 4 mm or less, 3.5 mm or less, 3 mm or less, 2.5 mm or less, 2 mm or less, or 1.5 mm or less). The inner diameter of the port303can range from any of the minimum values described above to any of the maximum values described above. For example, the port303can have an inner diameter of from 1 mm to 12 mm (e.g., from 1 mm to 6 mm, from 6 mm to 12 mm, from 1 mm to 4 mm, from 4 mm to 8 mm, from 8 mm to 12 mm, from 2 mm to 12 mm, from 1 mm to 11 mm, or from 2 mm to 11 mm).

Referring now toFIG.29, in some examples, the port303of the effluent separation module300is configured to be fluidly connected to a waste receptacle918, for example via an eighth tube920, the waste receptacle918being configured to receive the waste solution from the port303of the effluent separation module300.

For example, the port303of the effluent separation module300can be configured to be fluidly connected to the eighth tube920, wherein the eighth tube920is configured to fluidly connect the port303of the effluent separation module300to an waste receptacle918. In some examples, the kit100further comprises a waste receptacle918configured to be fluidly connected to the port303of the effluent separation module300. In some examples, the kit100further comprises an eighth tube920configured to fluidly connect the port303of the effluent separation module300to a waste receptacle918. In some examples, the kit100further comprises an eighth tube920and a waste receptacle918, wherein the eighth tube920is configured to fluidly connect the port303of the effluent separation module300to the waste receptacle918, the waste receptacle918being configured to receive the waste solution from the port303of the effluent separation module300.

The waste receptacle918can, for example, comprise any suitable container for containing the waste solution, such as those known in the art. In some examples, the waste receptacle918can comprise a flexible polymer collection bag, vacutainer, or vacuum canister. In some examples, the waste receptacle918can comprise a disposable medical collection bag. In some examples, the waste receptacle918containing the waste can be disposable as biohazard waste. The waste receptacle918can, for example, comprise any suitable material, such as those known in the art. For example, the waste receptacle918can comprise a polymer.

Referring now toFIG.30, in some examples, the outlet304of the effluent separation module300is configured to be fluidly connected to the collection reservoir108, for example via a ninth tube114, the collection reservoir108being configured to receive the desired component from the outlet304of the effluent separation module300. For example, the outlet304of the effluent separation module300can be configured to be fluidly connected to the ninth tube114, wherein the ninth tube114is configured to fluidly connect the outlet304of the effluent separation module300to the collection reservoir108. In some examples, the kit100further comprises a ninth tube114configured to fluidly connect the outlet304of the effluent separation module300to the collection reservoir108.

Referring now toFIG.31, in some examples, the outlet304of the effluent separation module300is configured to be fluidly connected to a container116, for example via a tenth tube118, the container116being configured to receive the desired component from the outlet304of the effluent separation module300.

For example, the outlet304of the effluent separation module300can be configured to be fluidly connected to the tenth tube118, wherein the tenth tube118is configured to fluidly connect the outlet304of the effluent separation module300to a container116. In some examples, the kit100further comprises a container116configured to be fluidly connected to the outlet304of the effluent separation module300. In some examples, the kit100further comprises a tenth tube118configured to fluidly connect the outlet304of the effluent separation module300to a container116. In some examples, the kit100further comprises a tenth tube118and a container116, wherein the tenth tube118is configured to fluidly connect the outlet304of the effluent separation module300to the container116, the container116being configured to receive the desired component from the outlet304of the effluent separation module300.

In some examples, the container116can be configured to be fluidly connected to the collection reservoir108, for example via an eleventh tube120, the collection reservoir108being configured to receive the desired component from container116. For example, the container116can be configured to be fluidly connected to the eleventh tube120, wherein the eleventh tube120is configured to fluidly connect the container116to the collection reservoir108. In some examples, the kit100further comprises an eleventh tube120configured to fluidly connect the container116to the collection reservoir108.

The container116can, for example, comprise any suitable container for containing the desired component, such as those known in the art. In some examples, the container116can comprise a sterile and/or flexible medical collection bag. The container116can, for example, comprise any suitable material, such as those known in the art. For example, the container116can comprise a polymer.

In some examples, the kit100further comprises the first tube902which is configured to fluidly connect the liposuction cannula900to the collection canister102.

In some examples, the kit100further comprises the liposuction cannula900. The liposuction cannula900can, for example, comprise any suitable cannula for liposuction such as those known in the art.

The first tube902, the second tube104, the third tube106, the fourth tube110, the fifth tube912(when present), the sixth tube916(when present), the seventh tube112(when present), the eighth tube920(when present), the ninth tube114(when present), the tenth tube118(when present), and the eleventh tube120(when present) independently can comprise any suitable material, such as those known in the art. For example, the first tube902, the second tube104, the third tube106, the fourth tube110, the fifth tube912(when present), the sixth tube916(when present), the seventh tube112(when present), the eighth tube920(when present), the ninth tube114(when present), the tenth tube118(when present), and the eleventh tube120(when present) independently can comprise a polymer. In some examples, the first tube902, the second tube104, the third tube106, the fourth tube110, the fifth tube912(when present), the sixth tube916(when present), the seventh tube112(when present), the eighth tube920(when present), the ninth tube114(when present), the tenth tube118(when present), and the eleventh tube120(when present) each comprise medical grade tubing.

The first tube902, the second tube104, the third tube106, the fourth tube110, the fifth tube912(when present), the sixth tube916(when present), the seventh tube112(when present), the eighth tube920(when present), the ninth tube114(when present), the tenth tube118(when present), and the eleventh tube120(when present) can each independently have an inner diameter of 2 mm or more (e.g., 3 mm or more, 4 mm or more, 5 mm or more, 6 mm or more, 7 mm or more, 8 mm or more, 9 mm or more, 10 mm or more, 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, or 24 mm or more). In some examples, The first tube902, the second tube104, the third tube106, the fourth tube110, the fifth tube912(when present), the sixth tube916(when present), the seventh tube112(when present), the eighth tube920(when present), the ninth tube114(when present), the tenth tube118(when present), and the eleventh tube120(when present) can each independently have an inner diameter of 25 mm or less (e.g., 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, 11 mm or less, 10 mm or less, 9 mm or less, 8 mm or less, 7 mm or less, 6 mm or less, 5 mm or less, 4 mm or less, or 3 mm or less). The inner diameter of the first tube902, the second tube104, the third tube106, the fourth tube110, the fifth tube912(when present), the sixth tube916(when present), the seventh tube112(when present), the eighth tube920(when present), the ninth tube114(when present), the tenth tube118(when present), and the eleventh tube120(when present) can independently range from any of the minimum values described above to any of the maximum values described above. For example, the first tube902, the second tube104, the third tube106, the fourth tube110, the fifth tube912(when present), the sixth tube916(when present), the seventh tube112(when present), the eighth tube920(when present), the ninth tube114(when present), the tenth tube118(when present), and the eleventh tube120(when present) can each independently have an inner diameter of from 2 mm to 25 mm (e.g., from 2 mm to 14 mm, from 14 mm to 25 mm, from 2 mm to 5 mm, from 5 mm to 10 mm, from 10 mm to 15 mm, from 15 mm to 20 mm, from 20 mm to 25 mm, from 4 mm to 25 mm, from 2 mm to 23 mm, from 4 mm to 23 mm, or from 2 mm to 10 mm).

The first pump904and the second pump906can independently comprise any suitable pump, such as those known in the art. In some examples, the first pump904and the second pump906can each independently be a peristaltic pump (e.g., a roller pump), a diaphragm pump, or a gear pump. In some examples, the first pump904and the second pump906are each independently a roller pump. In some examples, the kit further comprises the first pump904, the second pump906, or a combination thereof.

Referring now toFIG.32-FIG.34, in some examples, the kit100further comprises a first pressure sensor122configured to be fluidly connected to the second tube104between the first pump904and the collection canister102, wherein the first pressure sensor122is configured to detect the pressure between the first pump904and the collection canister102. In some examples, the first pressure sensor122is integrally formed with the second tube104.

In some examples, the kit100further comprises a second pressure sensor124configured to be fluidly connected to the second tube104between the first pump904and the adipose separation module200, wherein the second pressure sensor124is configured to detect the pressure between the first pump904and the adipose separation module200. In some examples, the second pressure sensor124is integrally formed with the second tube104.

In some examples, the kit further comprises a third pressure sensor126configured to be fluidly connected to the fourth tube110between the collection reservoir108and the second pump906, wherein the third pressure sensor126is configured to detect the pressure between the collection reservoir108and the second pump906. In some examples, the third pressure sensor126is integrally formed with the fourth tube110.

In some examples, the kit further comprises a fourth pressure sensor128configured to be fluidly connected to the fourth tube110between the second pump906and the injector908, wherein the fourth pressure sensor128is configured to detect the pressure between the second pump906and the injector908. In some examples, the fourth pressure sensor128is integrally formed with the fourth tube110.

In some examples, the kit100further comprises a first volume sensor130configured to be connected to the collection canister102and to detect the volume of the mixture within the collection canister102. In some examples, the first volume sensor130is integrally formed with the collection canister102.

In some examples, the kit100further comprises a second volume sensor132configured to be connected to the collection reservoir108and to detect the volume of the concentrated adipose tissue within the collection reservoir108. In some examples, the second volume sensor132is integrally formed with the collection reservoir108.

In some examples, the kit100further comprises the injector908, wherein the injector908is configured to receive the concentrated adipose tissue from the collection reservoir108via the fourth tube110and inject the concentrated adipose tissue into the second anatomical region, for example via an adipose injection cannula. The injector can comprise any suitable injector, such as those known in the art. For example, the injector can comprise a syringe.

In some examples, the injector908is configured to be fluidly coupled to an adipose injection cannula. In some examples, the injector908further comprises an adipose injection cannula. In some examples, the kit further comprises the adipose injection cannula. The adipose injection cannula can, for example, comprise any suitable cannula for adipose injection such as those known in the art.

In some examples, the injector908is configured to be fluidly connected to a fifth pressure sensor134, wherein the fifth pressure sensor134is configured to detect the pressure at which the injector908injects the concentrated adipose tissue into the second anatomical region. In some examples, the kit100further comprises the fifth pressure sensor134. In some examples, the injector908further comprises the fifth pressure sensor134. In some examples, the fifth pressure sensor134is integrally formed with the injector908.

Referring now toFIG.35, in some examples, the injector908comprises an ergonomic injection handle400has a longitudinal axis, a proximal end402, and a distal end404opposite and axially spaced apart from the proximal end402. In some examples, the kit further comprises the ergonomic injection handle400.

In some examples, the distal end404of the ergonomic injection handle400can be configured to be fluidly connected to an adipose injection cannula. In some examples, the proximal end402of the ergonomic injection handle400is configured to be fluidly connected to the collection reservoir108via the fourth tube110.

In some examples, the ergonomic injection handle400is configured to be coupled to an adipose injection cannula and the fourth tube110, wherein the fourth tube110fluidly connects the collection reservoir108to the adipose injection cannula.

The ergonomic injection handle400can comprise any suitable material, such as those known in the art. In some examples, the ergonomic injection handle400can comprise a polymer, a composite material, a metal, or a combination thereof. In some examples, the ergonomic injection handle400can comprise a polymer, such as polycarbonate, acrylonitrile butadiene styrene (ABS), poly(methyl methacrylate) (PMMA), polyvinyl chloride (PVC), an acrylic (e.g., a polyacrylic), nylon, polyester, polytetrafluoroethylene (PTFE), an acetal resin (e.g., Delrin®), polyether ether ketone (PEEK), derivatives thereof, or combinations thereof. In some examples, the ergonomic injection handle400can comprise a metal, such as titanium, stainless steel, derivatives thereof, or combinations thereof. In some examples, the ergonomic injection handle400can be disposable. In some examples, ergonomic injection handle400can be reusable.

In some examples, the ergonomic injection handle400has a length, the length being the dimension along the longitudinal axis from the proximal end402to the distal end404(e.g., “L inFIG.35). The ergonomic injection handle400can, for example, have a length of 10 centimeters (cm) or more (e.g., 11 cm or more, 12 cm or more, 13 cm or more, 14 cm or more, 15 cm or more, 16 cm or more, 17 cm or more, 18 cm or more, or 19 cm or more). In some examples, the ergonomic injection handle400can have a length of 20 cm or less (e.g., 19 cm or less, 18 cm or less, 17 cm or less, 16 cm or less, 15 cm or less, 14 cm or less, 13 cm or less, 12 cm or less, or 11 cm or less). The length of the ergonomic injection handle400can range from any of the minimum values described above to any of the maximum values described above. For example, the ergonomic injection handle400can have a length of from 10 cm to 20 cm (e.g., from 10 cm to 15 cm, from 15 cm to 20 cm, from 10 cm to 12 cm, from 12 cm to 14 cm, from 14 cm to 16 cm, from 16 cm to 18 cm, from 18 cm to 20 cm, from 11 cm to 20 cm, from 10 cm to 19 cm, or from 11 cm to 19 cm).

In some examples, the ergonomic injection handle400further comprises a hand grip portion406configured to allow a user to grip the ergonomic injection handle400comfortably and securely with a hand, the hand grip portion406being disposed towards the proximal end402.

The hand grip portion406can, for example, have an average outer diameter of 10 millimeters (mm) or more (e.g., 11 mm or more, 12 mm or more, 13 mm or more, 14 mm or more, 15 mm or more, 16 mm or more, 17 mm or more, 18 mm or more, 19 mm or more, 20 mm or more, 21 mm or more, 22 mm or more, 23 mm or more, 24 mm or more, 25 mm or more, 26 mm or more, 27 mm or more, 28 mm or more, or 29 mm or more). In some examples, the hand grip portion406can have an average outer diameter of 30 mm or less (e.g., 29 mm or less, 28 mm or less, 27 mm or less, 26 mm or less, 25 mm or less, 24 mm or less, 23 mm or less, 22 mm or less, 21 mm or less, 20 mm or less, 19 mm or less, 18 mm or less, 17 mm or less, 16 mm or less, 15 mm or less, 14 mm or less, 13 mm or less, 12 mm or less, or 11 mm or less). The average outer diameter of the hand grip portion406can range from any of the minimum values described above to any of the maximum values described above. For example, the hand grip portion406can have an average outer diameter of from 10 mm to 30 mm (e.g., from 10 mm to 20 mm, from 20 mm to 30 mm, from 10 mm to 15 mm, from 15 mm to 20 mm, from 20 mm to 25 mm, from 25 mm to 30 mm, from 12 mm to 30 mm, from 10 mm to 28 mm, or from 12 mm to 28 mm).

In some examples, the hand grip portion406comprises a contoured outer surface408having a plurality of undulations410which are spaced along the hand grip portion406, said undulations410generally conforming to the fingers of a user's hand.

In some examples, the ergonomic injection handle400further comprises a button412disposed within or proximate the hand grip portion406, such that the user can easily depress the button412with a finger on the hand gripping the hand grip portion406, wherein the button412is configured to inject the concentrated adipose tissue when depressed. In some examples, the button can be configured such that pressing the button causes a single dose of adipose tissue to be injected, a continuous flow of adipose tissue to be injected, or starting/stopping close loop control based on injection or interstitial pressure.

In some examples, the ergonomic injection handle400further comprises a feedback indicator, the feedback indicator being configured to provide feedback to a user. The feedback can, for example, comprise haptic feedback (e.g., a vibration motor), auditory feedback (e.g., an auditory alarm), visual feedback, or a combination thereof.

For example, the feedback indicator can comprise one of more visual indicators, such as a colored light emitting diode (LED). In some examples, the feedback indicator can comprise a plurality of LEDs, each LED having a different color, such as a red LED, a yellow LED, a green LED, or a combination thereof. The different colors can provide different feedback to the user.

In some examples, the ergonomic injection handle400is configured to be fluidly connected to the fifth pressure sensor134. In some examples, the ergonomic injection handle400further comprises the fifth pressure sensor134. In some examples, the fifth pressure sensor134is integrally formed with the ergonomic injection handle400.

In some examples, the components of the kit100are sterile.

Also disclosed herein are closed-loop adipose transplant systems comprising any of the kits100of consumable parts disclosed herein.

For example, also disclosed herein are closed-loop adipose transplant systems comprising a liposuction cannula900; a first tube902; a collection canister102; a second tube104; a first pump904; an adipose separation module200having an inlet202and an outlet204; a third tube106; a collection reservoir108; a fourth tube110; a second pump906; and an injector908. The components of the system together form a continuous, closed fluid pathway for the adipose tissue from the liposuction cannula900to the collection canister102through the first tube902, from the collection canister102to the inlet202of the adipose separation module200through the second tube104, from the inlet202to the outlet204through the adipose separation module200, from the outlet204of the adipose separation module200to the collection reservoir108through the third tube106, and from the collection reservoir108to the injector908through the fourth tube110.

In some examples, the first anatomical region and second anatomical region are different anatomical regions in a single subject. In some examples, the subject is a human. In some examples, the adipose tissue is human adipose tissue. In some examples, the first anatomical region comprises an abdomen or a thigh. In some examples, the second anatomical region comprises a breast or a buttock.

For example, the liposuction cannula900harvests a mixture comprising fat tissue from a first anatomical region. The first tube902fluidly connects the liposuction cannula900to the collection canister102. The collection canister102receives and collects the mixture from the liposuction cannula900via the first tube902. The second tube104fluidly connects the collection canister102to the inlet202of the adipose separation module200. The second tube104further fluidly connects the first pump904to the collection canister102and the adipose separation module200, such that the second tube104communicates a pressure applied by the first pump904, the pressure being sufficient to: transport the mixture through the second tube104from the collection canister102to the inlet202of the adipose separation module200. The adipose separation module200receives the mixture from the collection canister102through the inlet202and separates the adipose tissue from the mixture, thereby concentrating the adipose tissue from the mixture. The third tube106fluidly connects the outlet204of the adipose separation module200to the collection reservoir108. The collection reservoir108receives and collects the concentrated adipose tissue from outlet204of the adipose separation module200via the third tube106. The fourth tube110fluidly connects the collection reservoir108to the injector908. The fourth tube110further fluidly connects the second pump906to the collection reservoir108and the injector908, such that the fourth tube110communicates a pressure applied by the second pump906, the pressure being sufficient to: transport the concentrated adipose through the fourth tube110from the collection reservoir108to the injector908and inject the concentrated adipose tissue into a second anatomical region.

Methods

Also disclosed herein are methods of using any of the kits or systems disclosed herein, the methods comprising, for example, transplanting adipose tissue from a first anatomical region to a second anatomical region using any of the kits or systems disclosed herein.

In some examples, the method comprises breast reconstruction, breast augmentation, buttock augmentation, or a combination thereof. In some examples, the method comprises treatment of volume and/or contour abnormality in breast; treatment of congenital breast deformities; or a combination thereof.

Controllers and User Interfaces

Also disclosed herein are controllers for closed-loop adipose transplant systems. The controller is configured to be communicatively coupled to one or more components of any of the kits or systems disclosed herein. The controller, for example, comprises a user interface comprising a display showing real-time operating parameters and a control selection panel, and the control selection panel displays control parameters and includes: a selector (e.g., a button, an arrow, a slider, etc.) for starting and stopping an adipose transplant procedure upon selection by a user; and one or more selectors for allowing the user to modify one or more of the control parameters. Examples of the user interface are shown inFIG.36andFIG.37.

The real-time operating parameters can, for example, comprise: the volume detected by the first volume sensor (e.g., “the harvested volume”) (when present), the pressure detected by the first pressure sensor (e.g., the “pre-process pressure”) (when present), the pressure detected by the second pressure sensor (e.g., the “filter pressure”) (when present), the pressure detected by the third pressure sensor (e.g., “the collection pressure”) (when present), the pressure detected by the fourth pressure sensor (e.g., the “injection pressure”) (when present), the volume detected by the second volume sensor (e.g., “the processed fat volume”) (when present), the pressure detected by the fifth pressure sensor (e.g., the interstitial pressure) (when present), or a combination thereof.

The control parameters can, for example, comprise: a minimum volume for the first volume sensor, a maximum volume for the first volume sensor, a minimum pressure for the first pressure sensor, a maximum pressure for the first pressure sensor, a minimum pressure for the second pressure sensor, a maximum pressure for the second pressure sensor, a minimum pressure for the third pressure sensor, a maximum pressure for the third pressure sensor, a minimum pressure for the fourth pressure sensor, a maximum pressure for the fourth pressure sensor, a minimum volume for the second volume sensor, a maximum volume for the second volume sensor, or a combination thereof.

In some examples, the controller is further configured to provide feedback to a user when one or more of the real-time operating parameters approaches or exceeds one or more of the control parameters. The feedback can, for example, comprise haptic feedback, auditory feedback, visual feedback, or a combination thereof.

In some examples, the controller is further configured to be communicatively coupled to the means for rotating the rotary implement of the adipose separation module, the first pump, the second pump, or a combination thereof. In some examples, the controller is further configured to adjust the speed of the means for rotating the rotary implement of the adipose separation module, the first pump, the second pump, or a combination thereof such that one or more of the real-time operating parameters stay within the corresponding control parameters. In some examples, the speed of the first pump can be a ratio of the speed of the adipose separation module.

In some examples, the controller is communicatively coupled to the first pump such that when: the volume detected by the first volume sensor (e.g., “the harvested volume”) approaches or exceeds one of the control parameters for the first volume sensor (e.g., the minimum volume or the maximum volume for the first volume sensor), the pressure detected by the first pressure sensor (e.g., the “pre-process pressure”) approaches or exceeds the one of the control parameters for the first pressure sensor (e.g., the minimum pressure or the maximum pressure for the first pressure sensor), the pressure detected by the second pressure sensor (e.g., the “filter pressure”) approaches or exceeds one of the control parameters for the second pressure sensor (e.g., the minimum pressure or the maximum pressure for the second pressure sensor), or a combination thereof; then the controller is configured to adjust the speed of the first pump such that: the volume detected by the first volume sensor stays above the minimum volume or below the maximum volume for the first volume sensor, the pressure detected by the first pressure sensor (e.g., the “pre-process pressure”) stays above the minimum pressure or below the maximum pressure for the first pressure sensor, the pressure detected by the second pressure sensor (e.g., the “filter pressure”) stays above the minimum pressure or below the maximum pressure for the second pressure sensor, or a combination thereof.

In some examples, the controller is communicatively coupled to the means for rotating the rotary implement of the adipose separation module, the first pump, the second pump, or a combination thereof, such that when: the pressure detected by the second pressure sensor (e.g., the “filter pressure”) approaches or exceeds one of the control parameters for the second pressure sensor (e.g., the minimum pressure or the maximum pressure for the second pressure sensor), the pressure detected by the third pressure sensor (e.g., “the collection pressure”) approaches or exceeds on of the control parameters for the third pressure sensor (e.g., the minimum pressure of the maximum pressure for the third pressure sensor), or a combination thereof; then the controller is configured to adjust the speed of the means for rotating the rotary implement, the first pump, the second pump, or a combination thereof, such that: the pressure detected by the second pressure sensor (e.g., the “filter pressure”) stays above the minimum pressure or below the maximum pressure for the second pressure sensor, the pressure detected by the third pressure sensor (e.g., “the collection pressure”) stays above the minimum pressure or below the maximum pressure for the third pressure sensor, or a combination thereof.

In some examples, the controller is communicatively coupled to the second pump, such that when: the pressure detected by the third pressure sensor (e.g., “the collection pressure”) (when present) approaches or exceeds one of the control parameters for the third pressure sensor (e.g., the minimum pressure or the maximum pressure for the third pressure sensor), the pressure detected by the fourth pressure sensor (e.g., the “injection pressure”) (when present) approaches or exceeds one of the control parameters for the fourth pressure sensor (e.g., the minimum pressure or the maximum pressure for the fourth pressure sensor), the volume detected by the second volume sensor (e.g., “the processed fat volume”) (when present) approaches or exceeds one of the control parameters for the second volume sensor (e.g., the minimum volume or the maximum volume for the second volume sensor), or a combination thereof; then the controller is configured to adjust the speed of the second pump such that: the pressure detected by the third pressure sensor stays above the minimum pressure or below the maximum pressure for the third pressure sensor, the pressure detected by the fourth pressure stays above the minimum pressure or below the maximum pressure for the fourth pressure sensor, the volume detected by the second volume sensor stays above the minimum volume or below the maximum volume for the second volume sensor, or a combination thereof.

In some examples, the control selection panel further comprises a selector for starting and stopping flow of the wash liquid into the adipose separation module upon selection by a user. In some examples, the real-time operating parameters further comprise a flow rate for the flow of the wash liquid into the adipose separation module. In some examples, the control parameters further comprise a minimum flow rate for the flow of the wash liquid into the adipose separation module, a maximum flow rate for the flow of the wash liquid into the adipose separation module, or a combination thereof.

In some examples, the real-time operating parameters and/or the control parameters further comprise one or more additional parameters.

In some examples, the controller further comprises a computing device1000. The detection and/or adjustments of the controller can be carried out in whole or in part on one or more computing device. For example, the controller may comprise one or more additional computing devices.

FIG.38illustrates an example computing device1000upon which examples disclosed herein may be implemented. The computing device1000can include a bus or other communication mechanism for communicating information among various components of the computing device1000. In its most basic configuration, computing device1000typically includes at least one processing unit1002(a processor) and system memory1004. Depending on the exact configuration and type of computing device, system memory1004may be volatile (such as random access memory (RAM)), non-volatile (such as read-only memory (ROM), flash memory, etc.), or some combination of the two. This most basic configuration is illustrated inFIG.38by a dashed line1006. The processing unit1002may be a standard programmable processor that performs arithmetic and logic operations necessary for operation of the computing device1000.

The computing device1000can have additional features/functionality. For example, computing device1000may include additional storage such as removable storage1008and non-removable storage1010including, but not limited to, magnetic or optical disks or tapes. The computing device1000can also contain network connection(s)1016that allow the device to communicate with other devices. The computing device1000can also have input device(s)1014such as a keyboard, mouse, touch screen, antenna or other systems configured to communicate with the camera in the system described above, etc. Output device(s)1012such as a display, speakers, printer, etc. may also be included. The additional devices can be connected to the bus in order to facilitate communication of data among the components of the computing device1000.

The processing unit1002can be configured to execute program code encoded in tangible, computer-readable media. Computer-readable media refers to any media that is capable of providing data that causes the computing device1000(i.e., a machine) to operate in a particular fashion. Various computer-readable media can be utilized to provide instructions to the processing unit1002for execution. Common forms of computer-readable media include, for example, magnetic media, optical media, physical media, memory chips or cartridges, a carrier wave, or any other medium from which a computer can read. Example computer-readable media can include, but is not limited to, volatile media, non-volatile media, and transmission media. Volatile and non-volatile media can be implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data and common forms are discussed in detail below. Transmission media can include coaxial cables, copper wires and/or fiber optic cables, as well as acoustic or light waves, such as those generated during radio-wave and infra-red data communication. Example tangible, computer-readable recording media include, but are not limited to, an integrated circuit (e.g., field-programmable gate array or application-specific IC), a hard disk, an optical disk, a magneto-optical disk, a floppy disk, a magnetic tape, a holographic storage medium, a solid-state device, RAM, ROM, electrically erasable program read-only memory (EEPROM), flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices.

In an example implementation, the processing unit1002can execute program code stored in the system memory1004. For example, the bus can carry data to the system memory1004, from which the processing unit1002receives and executes instructions. The data received by the system memory1004can optionally be stored on the removable storage1008or the non-removable storage1010before or after execution by the processing unit1002.

The computing device1000typically includes a variety of computer-readable media. Computer-readable media can be any available media that can be accessed by device1000and includes both volatile and non-volatile media, removable and non-removable media. Computer storage media include volatile and non-volatile, and removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data. System memory1004, removable storage1008, and non-removable storage1010are all examples of computer storage media. Computer storage media include, but are not limited to, RAM, ROM, electrically erasable program read-only memory (EEPROM), flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by computing device1000. Any such computer storage media can be part of computing device1000.

It should be understood that the various techniques described herein can be implemented in connection with hardware or software or, where appropriate, with a combination thereof. Thus, the methods, systems, and associated signal processing of the presently disclosed subject matter, or certain aspects or portions thereof, can take the form of program code (i.e., instructions) embodied in tangible media, such as floppy diskettes, CD-ROMs, hard drives, or any other machine-readable storage medium wherein, when the program code is loaded into and executed by a machine, such as a computing device, the machine becomes an apparatus for practicing the presently disclosed subject matter. In the case of program code execution on programmable computers, the computing device generally includes a processor, a storage medium readable by the processor (including volatile and non-volatile memory and/or storage elements), at least one input device, and at least one output device. One or more programs can implement or utilize the processes described in connection with the presently disclosed subject matter, e.g., through the use of an application programming interface (API), reusable controls, or the like. Such programs can be implemented in a high level procedural or object-oriented programming language to communicate with a computer system. However, the program(s) can be implemented in assembly or machine language, if desired. In any case, the language can be a compiled or interpreted language and it may be combined with hardware implementations.

In certain examples, the controller comprises a computing device1000comprising a processor1002and a memory1004operably coupled to the processor1002, the memory1004having further computer-executable instructions stored thereon that, when executed by the processor1002, cause the processor1002to carry out one or more of the actions described above for the controller.

In certain examples, the controller comprises a computing device1000comprising a processor1002and a memory1004operably coupled to the processor1002, the memory1004having further computer-executable instructions stored thereon that, when executed by the processor1002, cause the processor1002to carry our one or more of the actions shown in the flow chart ofFIG.39.

The examples below are intended to further illustrate certain aspects of the systems and methods described herein, and are not intended to limit the scope of the claims.

EXAMPLES

Efforts have been made to ensure accuracy with respect to numbers (e.g., amounts, temperature, etc.) but some errors and deviations should be accounted for. Unless indicated otherwise, parts are parts by weight, temperature is in ° C. or is at ambient temperature, and pressure is at or near atmospheric. There are numerous variations and combinations of measurement conditions, e.g., component concentrations, temperatures, pressures and other measurement ranges and conditions that can be used to optimize the described process.

Disclosed herein are kits of consumable parts for adipose cell transplant systems, and systems and methods of use thereof.

The Adipose Cell Transplant System is a closed system that comprises three main sections: 1. Fat cell harvest, 2. Fat cell filtration and 3. Injector mechanism.

The fat-cell solution are initially suctioned out of a patient through a liposuction cannula900, with the suction pressure created by a roller pump904, which then transports the fat solution into the filtration mechanism200. An auger230can rotate (e.g., in a clockwise direction), transporting the fat solution and applying pressure on a filtration net210that surrounds the auger230, while receiving lactate solution to keep the fat solution moist and flush out the non-fat cell materials. The filtration net210then separates the fat cells from the solution and disposes of the excess waste. The filtered fat cells are then be suctioned out by a second roller pump906and inserted into an injector908that injects the fat cells into the desired anatomical location of the patient.

An example system is shown inFIG.40. This is a closed system comprising three parts. The first part is for fat collection, the second is for fat processing, and the third part is for fat injecting. The first part comprises a suction cannula900, tubing902, and collection cannister102. The second part comprises a first pressure sensor (P1)122, first roller pump (RP1)904, fat filtration module200, and second pressure sensor (P2)124. The third part contains a fat reservoir bag108, a third pressure sensor (P3)126, a second roller pump (RP2)906, a fourth pressure sensor (P4)128, and injection handle908. The fat reservoir bag is between the fat processing and fat injection components.

Two roller pumps are used to move the fat cells through the system. Typically, other systems use pressure filtration (syringe pressure for example) or centrifugation, which both use of pressure, which may be damaging is not ideal for transferring fat cells.

The two pump design offers the ability to harvest and process the fat at the same time in a closed system, which is not available with any products currently on the market. The first roller pump (RP1)904is used to harvest the fat mixture and transport the fat mixture from the vacutainer102into the fat filtration module200. The second pump (RP2)906is used to propel the harvested fat from the reservoir bag108to the injector908upon surgeon actuation, e.g., upon actuation of a switch on the injector handle908.

An example image of a roller pump using medical grade tubing is shown inFIG.42.

A reservoir storage bag108that is located between the two roller pumps permits the pumps to have the capacity to operate at different speeds. This feature can be used to optimize the control of harvest speed to what is required by the surgeon, eliminating waiting time for fat filtering and processing. Processing and injecting do not need to occur at the same rate because of the reservoir bag108which is between the fat filtration module200and the injector908.

The fat filtration module200is the main filtration mechanism for the system. In some examples, the fat filtration module200includes a rotary implement230, such as an auger, that pumps the fat cells along the surrounding filter210to concentrate the fat and remove the liquid portion. The auger230can also serve as a cleaning function for the filter210, creating a wiping function as it rotates. The auger230can, in some examples, have a variable pitch. In some examples, the auger230cab be attached to a titanium rod244, which can then be attached to a flexible shaft coupler that securely holds the motor shaft and auger230. The auger230can be made of polycarbonate, and has a very smooth surface finish, with a rigid, strong body. The fat cell solution will rotate within the auger230, allowing the solution to be moist from the Lactated Ringers while sifting out all the excess waste. The auger-motor assembly can be placed within a titanium rod.

The motor228can be a gear motor with a controllable speed such as from 2 to 25 RPM, or from 15-20 RPM.

The wash liquid, such as lactated ringers solution, can enter the fat filtration module200through an orifice205, optionally together with 0.25 inch tubing and a 1/16 NPT fitting, and can be controlled by a pressure transducer.

The first roller pump904injects the mixture into the fat filtration module200through an inlet202optionally together with tubing. The amount of pressure and volume of the mixture in the fat filtration module200can be monitored. The speed of rotation of the auger230can be adjusted based on the amount of the mixture injected into the fat filtration module200. The flow rate of the first roller pump904can be adjusted, for example between 20 mL/min to 200 mL/min, such as from 50 to 75 mL/min.

The lactated ringers solution can contact the mixture in the fat filtration module. The rate the lactated ringers solution flows into the fat filtration module can be controlled based on how much “washing” of the mixture is desired.

Excess waste materials and lactated ringers solution pass through the filter210into a second compartment214in the fat filtration module210, which can then transport the waste towards a port203.

The filtered adipose cells can exit the fat filtration module200through an outlet204. In some examples, the outlet204is positioned at a right angle relative to the longitudinal axis of the auger230. The amount of pressure applied to the filtered adipose cells by the second roller pump906can be controlled by variable parameters in a control panel. The flow rate of the second roller pump906can be adjusted, for example between 10 and 180 mL/min, such as from 60 to 90 mL/min.

The waste material (e.g., effluent) can proceed through the port203and optionally through 3/16 tubing and 1/16 NPT fitting.

The spacing between the edge of the auger230and the interior cavity208in the fat filtration module200can be adjusted to improve the pumping performance of the auger230and minimize dead space.

The near-tight fitting of the auger230inside the interior cavity208can allow the fat cells to move with enough pressure to force out the excess waste from the fat solution, as well as not too much pressure to where the fat cells will break. The auger230can be positioned along the centerline of the filter cage222and nylon mesh filter210with a small clearance between the auger230and the filter210(“tip clearance”), which allows for efficient separation of the adipose cells from the mixture, without damage to the adipose cells. The auger rod244and shaft coupler can be positioned outside the housing206, allowing access to the gear motor228for easy changes. Therefore, the fat filtration module200can be readily removed from the motor228so that it can be disposed properly and filter210can be changed.

As shown inFIG.43andFIG.44, there is a small space between the edge of the blade238of the auger230and the filter cage222. Within this space, the nylon mesh filter210can be held. When fixed in place, the nylon mesh filter210can make a cylinder disposed circumferentially about and coaxially with the auger230, and can contain the fat cell solution.

In some examples, the auger230can comprise a variable pitch auger230. The variable pitch of the auger230can optimize the pumping of semi solids as liquid is extracted. A formula can be used to estimate volumetric flow through the auger by using a linear rate of change in the auger pitch, using variables for total flow through the auger:

Where Q is the volumetric flow rate (mL/s), P1is the pitch of the auger at the inlet (inches/revolution), P2is the pitch of the auger at the outlet (inches/revolution), L is the length of the auger (inches), ω is the motor speed (revolution per minute), OD is the outer diameter of the auger (inches), and ID is the inner diameter of the auger (inches).

This equation assumes a linear pitch rate change over the auger length. The two biggest contributors to the volumetric flow is the annular area controlled by the outer diameter (OD) and inner diameter (ID) of the auger, and the rotational speed of the auger. The average pitch can be used to calculate the speed of the media through the auger.

An example of a variable pitch auger230is shown inFIG.6.

An optional sliding ring224can be added to the fat filtration module200to facilitate the clearing action of the auger230. An example fat filtration module200including the sliding ring224is shown inFIG.13,FIG.45, andFIG.46.

A cage222surrounds the auger230that holds the filter210, which can be metal mesh or any filter material. This permits the use of a variety of different filter sizes. Variable filter sizes can be easily changed to the preference of a user. For example, different micron sized filters can be selected for types of fat in different body locations (legs, abdomen, back, etc.), as these different body areas can have different textures of fat. The filter material (polymer or metal, such as titanium) can be an flexible or pliable material that is used in conjunction with the cage222for support.

The cage222around the filter210can be customized. For example, the cage222can be a flexible polymer cage, a rigid cage, etc. An example of a filter cage222is shown inFIG.47.

The use of the filter cage makes the filter a cartridge style set up. For example, the use of the filter cage provide the ability to change the filter during a treatment intraoperatively in the sterile field. This feature can allow operative staff to quickly change filters during a treatment in case different micron sizes were needed or in the event that the filter became clogged. This enables the filter to be changed out as many times as needed in any given surgical case.

An example exploded view of the fat filtration module200including the auger230and filter cage222is shown inFIG.48.

The systems also include the ability to add a secondary filter (e.g., an effluent separation module300) to process the effluent with a smaller pore filter and capture additional PRP and/or stem cells and add them back to the fat cells for injection to optimize their take.

The fat filtration module200includes two outflow components, a port203which goes to a collection bag for PRP and stem cells, and an outlet204which takes the fat to the injector handle208. An example system including an effluent separation module300is shown inFIG.41. The whole system can be two stages, the first for fat concentration and the second for filtering of the effluent. The second stage filter can be an effluent separation module including an auger, or a membrane filter.

The fat concentration can be controlled by the differential speed between the first roller pump904and the auger230, thereby controlling the viscosity of the transplanted fat.

The system can include pressure sensors, such as a first pressure sensor122, a second pressure sensor124, a third pressure sensor126, and a fourth pressure sensor128as shown inFIG.40andFIG.41.

The first pressure sensor122can be located between the collection canister102and the first roller pump904. The first pressure sensor122can detect whether or not there is liposuction material in the collection canister102. Pressure bounds can be set so that the fat cells are not damaged by excessive negative pressure. The system can modulate the speed of the first roller pump904to stay within the pressure bounds.

The second pressure sensor124can be located between the first roller pump904and the fat filtration module200. The second pressure sensor124can help the system determine the change in pressure over time, and also help regulate the speed ratio of the first roller pump904to the auger230so there is always sufficient material to keep the filtration at the correct operating speed. The second pressure sensor124can act as a safety mechanism; if there is no place for liquid to go (e.g., fat filtration module200is clogged or collection reservoir108is full), the system will slow down or stop the first roller pump904.

The third pressure sensor126can be located between the collection reservoir108and the second roller pump906. The third pressure sensor126can detect if there is concentrated fat available to be dispensed by the surgeon. The third pressure sensor126can also detect if the collection reservoir108is full.

The fourth pressure sensor128can be located between the second roller pump906and the injector908. The fourth pressure sensor128can detect and control the injection pressure of the fat. Closed loop control on this pressure can be implemented to maintain constant injection pressure to provide precise dispensing control.

The system can further include a pressure sensor that detects the tissue interstitial pressure at the injection site. Pressure sensors/control at the injection site can prevent injecting into the muscle or vasculature. This is a safety feature that can prevent dangerous fat emboli. The pressure sensor can be built into the injector handle, which can further display the detected pressure.

The pressure sensors can, for example, be teed off of the tubing so that it does not clog. An image of an example pressure sensor is shown inFIG.49.

A pressure system logic diagram is shown inFIG.39.

An instrumentation control panel serves as a digital dashboard for the fat grafting system. The thickness of the fat (wet, dry, etc.) is controlled by the speed of the fat filtration module. The rate of filtration also influences the concentration of the fat. Two filters can be set up in parallel, and the first and second filtrate can be controlled. Pressures can be visualized with data from the pressure sensors. Different gauges can show pressure and volume readings at different locations. The panel can show the entire system is working and what is occurring at various locations throughout the system.

Example user interfaces for the controllers are shown inFIG.36andFIG.37.

An example block diagram for motor/pump control is shown inFIG.50. The software can control the speed of the motor/pump. Various digital and analog signals can be taken from pressure transducers and volume detectors. All variables can be inserted into a block diagram, like the one shown inFIG.50, to automate how much fat cell solution and filtered solution is going through the fat-cell separator200.

Rates of processing can be controlled, which controls the fat concentration: rate of processing (speed of first roller pump and auger), control of concentration (ratio of first roller pump and auger speed), rate of injection (second roller pump), closed loop control of interstitial injection pressure (second roller pump and fourth pressure sensor), safety thresholds of pressure sensors (tissue pressure, fourth pressure sensor), and safety thresholds for the first, second, and third pressure sensors (not too high or too low, to avoid damaging fat cells).

In some examples, the injector908comprises an ergonomic injection handle, such as the one shown inFIG.35. The injection handle can be ergonomically designed to optimize the tactile control and precision for fat cell injection. The ergonomic injection handle can include a single button control for automatic injection with feedback for pressure threshold control. The feedback could be a vibration motor inside of the handle (haptic feedback), an audible annunciator (auditory feedback), or LED (visual feedback). The second roller pump generates pressure so that injection with a traditional syringe is not required by the surgeon, thereby lessening the physical burden that is currently required. An option for retractable injector needle with pressure fail safes is possible. The surgeon will also have the ability to lock the retractable needle in place. Safety features using pressure sensors can be important for preventing fat embolism in patients, and does not currently exist in any system on the market.

The ergonomic injection handle can be designed to be used with standard available cannulas. The ergonomic design can be optimized for surgical performance. A single button can control the second roller pump.

Disclosed herein are fat-cell transplant systems, for example as shown inFIG.55. The fat-cell solution can be suctioned out of a patient through a cannula900, with the suction pressure created by a roller pump that is controlled, for example, through LabVIEW. A roller pump904can then transport the fat solution into the fat filtration module200. An auger can rotate, for example in a clockwise direction, transporting the fat solution and applying pressure on a filtration net that surrounds the auger, while receiving lactate solution to keep the fat solution moist and flush out the non-fat cell materials. The filtration net210can then separate the fat cells from the solution and dispose of the excess waste. The filtered fat cells can then be suctioned out by a second roller pump906and inserted into an injector908that can inject the fat cells into the desired anatomical location of the patient.

The roller pumps and motor rotating the auger can be controlled through LabVIEW. Sterile pressure transducers can be in line at locations PV1, PV2, PV3, etc. Based on the pressure detected at each location, the speed of the pumps and motors can be automatically controlled through LabVIEW software. At location PV4, the value of the pressure detected can trigger a switch that allows the injector to begin exporting the filtered fat cells.

The auger230can, for example, be 3-D printed from Accura Xtreme White Normal-Resolution Stereolithography (SLA) material and can be attached to a M3-threaded titanium rod244, which can then be attached to a motor hex coupler that securely holds the motor shaft and auger, as depicted inFIG.56. The motor228can, for example, be a 30 RPM gear motor, which can also be controlled by LabVIEW.

The auger-motor assembly can be placed within a ¾″ titanium cage222, as depicted inFIG.57, where the mesh-filter210can be attached to the interior of the cage222to filter out the fat cells. The length of the cage222can be as long as the auger230itself, for example 10 cm. The near-tight fitting of the auger230inside the cage222can allow the fat cells to move with enough pressure to force out the excess waste from the fat solution, as well as not too much pressure to where the fat cells will break. This small clearance is depicted inFIG.58, where the green circle depicts the location of the clearance where the filter210will be placed, The clearance can, for example, be 1 millimeter (mm) or less.

The titanium cage222can sit inside a polycarbonate housing206for the filtration mechanism200. There are various inlet and outlet ports on the system200.

The adipose separation module200can include a second compartment214where the excess solution (e.g., effluent) that was filtered out by the auger and mesh filter is collected. The module200can include a port203fluidly connected to the second compartment214for removal of the effluent.

The adipose separation module200can include an orifice205for introducing a wash liquid, such as lactated ringers, into the mixture as it goes through the auger. While the auger rotates the solution around to apply pressure to filter out excess waste, the lactate solution will slowly drip throughout the fat mixture to keep the solution moist, easing the flow through the auger and making the filtration process easier.

The Lactate solution and fat-cell solution can be inserted into the filtration system200through ¼″ standard tubing, while the effluent and filtered fat cells can exit through 3/16″ tubing. The primary reason for different sizes is to help identify where each piece of the system goes and to take caution by not allowing too easy of a flow or too tight of low, which could damage the fat cells. The 3/16″ tubing can go into a leur lock that connects to an injector and cannula needle that will reinsert the fat cells into the host patient.

FIG.59depicts the entire system with detailed labels for each location shown. Location descriptions: (1) fat cell solution can be pumped904into here, (2) a pressure transducer can detect the fat solution, initiating the release of lactate solution and rotation of auger, (3) Filtration System200, (4) excess waste can leave this direction, and (5) filtered fat cells can be suctioned through this pump906into the injector.

FIG.60is a schematic diagram for the injector908that can be used be used to reinsert the fat cells, which can be 3-D printed. Location descriptions: (1) 3/16 ID Tubing Barbed fitting, inlet hole for filtered Fat Solution, (2) location of an on/off switch, user control fat cell pump, and (3) leur locking mechanism for cannula of choice. The needle is approximately 1.2 inches in diameter, with finger grooves at the bottom to allow ease of hold. The injector can also include a switch, which can allow the user to control when to pump in the filtered fat cells.

Described herein are systems and kits for fat grafting, such as autologous fat grafting. Autologous fat grafting is a surgical procedure that involves harvesting, processing, and transferring adipose tissue from one anatomical region of the patient to another.

Fat grafting is mainly used for the treatment of volume and contour abnormalities and congenital breast deformities. It is a technically demanding and time-consuming procedure involving several steps to harvest, process, and transfer fat. Current fat grafting techniques lack integration of the components in each step.

A whole closed system could potentially optimize operating times and automation of the injection of the cells that control both the injection rate and corresponding needle retraction to improve the ease and efficacy of fat grafting.

Disclosed herein is a closed system for fat cell transplant including: collection of fat tissue through liposuction, washing the mixture to remove non-fat cell biologic waste, concentrating only the fat cells, and then re-injecting the concentrated fat cells back into the patient where they are needed. The specific device that washes and concentrates the fat cells can include an auger mechanism within a filter screen where the fat cells are moved along the auger while the other cells and washing fluid fall through the filter screen.

Commercial systems require manually squeezing the waste material through a screen embedded in a IV-like bag. This is a subjective process, requires additional personal and replacement of bags and tubing exposing the concentrated fat cells to the open air. The closed system disclosed herein can be motor driven, reduce the clinical supported required, allow continuous liposuction and fat cell transplant, and minimize the chances of contamination of the concentrated fat cells.

Fat grafting has increased in popularity as is a major adjunct in breast reconstruction and breast augmentation. Currently there are few devices to facilitate fat graft transfer, all have significant limitations. These limitations include intraoperative inefficiency, inability to graft and process at the same time, ergonomics, manual injection, and quality of fat harvested. To solve these problems, an all in one closed system is described herein that allows processing and harvesting fat with an automatic injection handle that has a pressure sensor to fine tune the fat injection process. This can allow concurrent harvesting and processing of fat with precise control of pressure which can be important for fat cell integrity.

Autologous fat grafting is a surgical procedure that involves harvesting, processing, and transferring adipose tissue from an anatomical region of the patient to another. Over the past decade, autologous fat grafting has become a widespread procedure, according to the American Society of Plastic Surgeons (ASPS), 31,862 fat grafting procedures were performed for breast reconstruction during 2017 in the U.S. Furthermore, it is considered the plastic surgery technique which has evolved the most over the past 30 years (American Society of Plastic Surgeons (ASPS). 2017 Plastic Surgery Statistics Report. Available from: https://www.plasticsurgery.org/news/plastic-surgery-statistics. Published 2017).

Specifically, in breast reconstruction, fat grafting is mainly used for the treatment of volume and contour abnormalities, as well as for more severe cases of congenital breast deformities. It also improves skin texture and scarring especially in post-radiated reconstruction.

Although, it is a safe procedure with low complication rates, it is technically demanding and time-consuming since it involves several steps to transfer the adipose tissue to the desire anatomical location successfully. The steps involved are as follows: (1) Harvesting: with the help of a liposuction cannula, the desired amount of fat is suctioned from the patient. (2) Processing: This involves different techniques to filter the viable adipose tissue from plasma, blood remnants, and lysed adipocyte cells. (3) Fat transfer: This is the last step and involves the use of a syringe that controls the flow rate and volume of fat that is transferred.

Current fat grafting technologies lack integration in the components of each step, meaning that technology has been developed for each element rather than for a whole closed system that could potentially optimize operating times and the plastic surgeon fat grafting experience. Disclosed herein is a closed fat grafting system that can optimize operating times during fat grafting procedures.

The bioavailability of the processed fat grafting using the systems and methods herein can be assessed using a well-described mouse model performing xenografts using human fat (Lujan-Hernandez J et al. Experimental in-vivo models used in fat grafting research for volume augmentation in soft tissue reconstruction.Arch Plast Surg.2017; 44(5):361-369).

An example system is shown inFIG.61. The fat-cell solution can be suctioned out of a patient through a cannula and transferred into a collection cannister102.

A roller pump904can then transport the fat solution into the fat filtration module200. In some examples, the fat solution can be washed with a wash liquid between the collection cannister and the fat filtration module, for example prior to the first roller pump.

In the fat filtration module200, an rotary implement can rotate, for example in a clockwise direction, transporting the fat solution and applying pressure on a filter that surrounds the rotary implement, while receiving lactate solution to keep the fat solution moist and flush out the non-fat cell materials. The filter210can then separate the fat cells from the solution and dispose of the excess waste. The filtered fat cells can then be suctioned out by a second roller pump906and inserted into an injector908that can inject the fat cells into the desired anatomical location of the patient.

The systems also include the ability to add a secondary filter (e.g., an effluent separation module300) to process the effluent with a smaller pore filter and capture additional PRP and/or stem cells and add them back to the fat cells for injection to optimize their take.

The system can further include a pressure sensor (P5)134that detects the tissue interstitial pressure at the injection site. Pressure sensors/control at the injection site can prevent injecting into the muscle or vasculature. This is a safety feature that can prevent dangerous fat emboli. The pressure sensor can be built into the injector handle, which can further display the detected pressure.

Other advantages which are obvious and which are inherent to the invention will be evident to one skilled in the art. It will be understood that certain features and sub-combinations are of utility and may be employed without reference to other features and sub-combinations. This is contemplated by and is within the scope of the claims. Since many possible embodiments may be made of the invention without departing from the scope thereof, it is to be understood that all matter herein set forth or shown in the accompanying drawings is to be interpreted as illustrative and not in a limiting sense.

The methods of the appended claims are not limited in scope by the specific methods described herein, which are intended as illustrations of a few aspects of the claims and any methods that are functionally equivalent are intended to fall within the scope of the claims. Various modifications of the methods in addition to those shown and described herein are intended to fall within the scope of the appended claims. Further, while only certain representative method steps disclosed herein are specifically described, other combinations of the method steps also are intended to fall within the scope of the appended claims, even if not specifically recited. Thus, a combination of steps, elements, components, or constituents may be explicitly mentioned herein or less, however, other combinations of steps, elements, components, and constituents are included, even though not explicitly stated.