Systems and methods for performing an autologous adipose tissue transplant

Abstract

The invention relates to a method for performing an autologous adipose tissue transplant in a patient. The method may include extracting a first amount of adipose tissue from the patient into a first syringe and extracting a second amount of adipose tissue from the patient into a second syringe. The first amount of adipose tissue can be decanted to isolate the fat from the first amount of adipose tissue. The second amount of adipose tissue can be transferred into a collection tube. A stromal vascular fraction can be isolated from the second amount of adipose tissue, the stromal vascular fraction being collected in a distal portion of the collection tube. The stromal vascular fraction can then be combined with the fat, and the fat and stromal vascular fraction can be deposited into the patient.

Description

SYSTEMS AND METHODS FOR PERFORMING AN AUTOLOGOUS ADIPOSE TISSUE TRANSPLANT

[0001] FIELD

[0002] In general, this disclosure relates to systems, kits and methods for performing autologous adipose tissue transplants and, more specifically, to systems, kits and methods that include customized and / or modified components that increase the efficiency of autologous adipose tissue transplant procedures and reduce the risk of contamination of the transplanted adipose tissue.

[0003] BACKGROUND

[0004] Autologous adipose tissue transplantation requires precise control of the extraction, processing, and reintroduction of the transplanted tissue to ensure tissue viability and the success of the transplant procedure. Adipose tissue harvested from a patient may undergo several processing steps before being transplanted, which may involve transferring the tissue between multiple recipients and specialized equipment during the transplant procedure. Special care must be taken during all phases of the procedure to ensure that the tissue remains viable and free of microbiological contaminants, which can result in graft failure and atrophy of the transplanted tissue. Any time tissue is transferred between recipients, there is a risk of tissue contamination. The transfer steps also increase the amount of equipment required for the transplant procedure and increase the duration of transplant procedures.Furthermore, many existing autologous transplantation methods require enzymes, such as collagenase, which are banned by the FDA and contraindicated by the European Union for use in transplanted tissue. Therefore, conventional tissue transplantation methods can be improved by reducing the amount of equipment involved in extracting, processing, and reintroducing tissue into a patient; by reducing the number of transfer steps involved in the procedure; by improving the equipment used to reduce the risk of recurrence; and by eliminating the need for additional enzymes for tissue processing. Systems, kits, and methods that address these needs are presented here. Such systems, kits, and methods may be useful for tissue bioengineering, regenerative medicine, plastic surgery, and medical device applications.

[0005] SUMMARY

[0006] Described herein are systems, kits, and methods for performing an autologous tissue transplant procedure with a lower risk of graft failure and greater efficiency compared to conventional methods. The systems and kits described herein may include a set of surgical instruments, accessories, and equipment used for the extraction, processing, and / or transplantation of adipose tissue. Specifically, the methods may involve extracting quantities of adipose tissue from the patient, processing the adipose tissue to isolate the fat and a stromal vascular fraction from the tissue, combining the fat and stromal vascular fraction, and depositing the fat and stromal vascular fraction mixture elsewhere in the patient's body. The systems, kits, and methods described herein may be used in volumetric fat grafting procedures in various body regions, such as the face, abdomen, breasts, arms, or legs of a patient.

[0007] In some embodiments, a method is provided for performing an autologous adipose tissue transplant in a patient. In some embodiments, the method includes: withdrawing a first amount of adipose tissue from the patient into a first syringe; withdrawing a second amount of adipose tissue from the patient into a second syringe; decanting the first amount of adipose tissue to isolate the fat from the first amount of adipose tissue; transferring the second amount of adipose tissue to a collection tube; isolating a stromal vascular fraction from the second amount of adipose tissue; combining the stromal vascular fraction with the fat; and depositing the fat and the stromal vascular fraction in the patient. In some embodiments, isolating the stromal vascular fraction results in the stromal vascular fraction being collected in a distal portion of the collection tube.

[0008] In some embodiments, the first amount of adipose tissue is received into the first syringe via an aspiration cannula connected to the first syringe. In some embodiments, isolating the stromal vascular fraction from the second amount of adipose tissue involves using a centrifuge to centrifuge the second amount of adipose tissue. In some embodiments, a collection tube is inserted into the centrifuge. In some embodiments, the collection tube comprises a seal that creates a fluid-tight seal against an inner diameter of the collection tube, wherein the seal comprises a fluid-tight inlet port. In some embodiments, combining the stromal vascular fraction with fat involves transferring the stromal vascular fraction and fat to a third syringe. In some embodiments, transferring the stromal vascular fraction involves removing the stromal vascular fraction through the fluid-tight inlet port.In some embodiments, the stromal vascular fraction is removed through the fluid-tight inlet port using an injection cannula. In some embodiments, the method further includes, prior to depositing the fat and stromal vascular fraction into the patient, attaching a pressure-controlled plunger to the third syringe. In some embodiments, the third syringe includes a pressure-controlled plunger. In some embodiments, the fat and stromal vascular fraction are deposited into the patient via an injection cannula attachable to the third syringe. In some embodiments, the volume of the first amount of adipose tissue is approximately equal to the volume of the second amount of adipose tissue.

[0009] In some embodiments, a system is provided for performing an autologous adipose tissue transplant in a patient. In some embodiments, the system includes: a first syringe for extracting a first quantity of adipose tissue from the patient; a second syringe for extracting a second quantity of adipose tissue from the patient; a collection tube configured to receive the first quantity of adipose tissue and further configured to isolate a stromal vascular fraction from the first quantity of adipose tissue; a decantation stand for decanting the first quantity of adipose tissue to isolate fat from the first quantity of adipose tissue; a centrifuge configured to receive the collection tube, wherein the centrifuge is operable to isolate a stromal vascular fraction from the second quantity of adipose tissue in the collection tube; and a third syringe for depositing the fat and the stromal vascular fraction into the patient.In some embodiments, the collection tube includes a seal. In some embodiments, the seal creates a fluid-tight seal against an inner diameter of the collection tube. In some embodiments, the seal includes a fluid-tight inlet port. In some embodiments, isolating the stromal vascular fraction from the second amount of adipose tissue results in the stromal vascular fraction being collected in a distal portion of the collection tube. In some embodiments, the stromal vascular fraction can be removed from the collection tube through the fluid-tight inlet port while maintaining the fluid-tight seal of the seal against the inner diameter of the collection tube.

[0010] In some embodiments, the system further includes an aspiration cannula attachable to the first syringe. In some embodiments, the first amount of adipose tissue is extracted from the patient through the aspiration cannula. In some embodiments, the system further includes an injection cannula attachable to the third syringe. In some embodiments, the injection cannula is distinct from the aspiration cannula. In some embodiments, the stromal vascular fraction is removed from the collection tube via the injection cannula. In some embodiments, the fat and stromal vascular fraction are deposited into the patient via the injection cannula. In some embodiments, the system further includes a transfer device attachable to the first syringe and the third syringe. In some embodiments, the decanted fat can be transferred from the first syringe to the third syringe via the transfer device.

[0011] In some embodiments, a kit is provided for performing an autologous adipose tissue transplant in a patient. In some embodiments, the kit includes: a first syringe for extracting a first quantity of adipose tissue from the patient; a second syringe for extracting a second quantity of adipose tissue from the patient; a collection tube configured to receive the second quantity of adipose tissue and further configured to isolate a stromal vascular fraction from the second quantity of adipose tissue; and a third syringe configured to deposit fat and the stromal vascular fraction into the patient, wherein the fat is isolated from the first quantity of adipose tissue by decanting the first quantity of adipose tissue. In some embodiments, the collection tube includes a seal. In some embodiments, the seal creates a fluid-tight seal against an inner diameter of the collection tube. In some embodiments, the seal includes a fluid-tight inlet port.In some embodiments, isolation of the stromal vascular fraction from the second amount of adipose tissue results in the stromal vascular fraction being collected in a distal portion of the collection tube. In some embodiments, the stromal vascular fraction can be removed from the collection tube through the fluid-tight inlet port while maintaining the fluid-tight seal of the seal against the inner diameter of the collection tube.

[0012] In some embodiments, the kit further includes an aspiration cannula attachable to at least one of the first syringe and the second syringe. In some embodiments, the aspiration cannula serves to extract at least one of the first quantity of adipose tissue and the second quantity of adipose tissue from the patient. In some embodiments, the kit further includes an injection cannula attachable to the third syringe. In some embodiments, the injection cannula serves to deposit the fat and the stromal vascular fraction into the patient, wherein the injection cannula is distinct from the aspiration cannula. In some embodiments, the injection cannula is configured to remove the stromal vascular fraction from the collection tube through the fluid-tight inlet port. In some embodiments, the kit further includes a pressure control plunger attachable to the first syringe and the third syringe.In some embodiments, fat can be transferred from the first syringe to the third syringe via the transfer device.

[0013] It will be appreciated that any of the variations, aspects, features, and options described herein apply equally to the systems, kits, and methods, and vice versa. It will also be clear that any one or more of the above variations, aspects, features, and options can be combined. Additional advantages will be readily apparent to those skilled in the art based on the detailed description below. The aspects and descriptions contained herein should be considered illustrative and not restrictive.

[0014] All publications, including patent documents, scientific articles, and databases, mentioned in this application are incorporated by reference in their entirety for all purposes, to the same extent as if each individual publication were incorporated individually by reference. If a definition set forth herein is contrary to or otherwise inconsistent with a definition set forth in the patents, applications, published applications, and other publications incorporated herein by reference, the definition set forth herein prevails over the definition incorporated by reference.

[0015] The embodiments will now be described, by way of example only, with reference to the attached drawings, in which:

[0016] [Fig. 1A] illustrates an exemplary set of syringes according to some of the embodiments disclosed herein.

[0017] [Fig. 1B] illustrates an exemplary female sealing cap attachable to a distal tip of a syringe, according to some of the embodiments disclosed herein.

[0018] [Fig. 1C] illustrates an exemplary two-stage lock in accordance with some of the embodiments disclosed herein.

[0019] [Fig. 1D] illustrates an exemplary decoupling system for a syringe plunger, according to some of the embodiments disclosed herein.

[0020] [Fig. 1E] illustrates insertion of an exemplary needle into a seal with a fluid-tight inlet port, according to some of the embodiments disclosed herein.

[0021] [Fig. 1F] illustrates an exemplary sealing cap mated with a proximal opening of a syringe, according to some of the embodiments disclosed herein.

[0022] [Fig. 1G] illustrates an exemplary collector tube according to some of the embodiments disclosed herein.

[0023] [Fig. 2A] illustrates an exemplary aspiration cannula for infiltration and collection of adipose tissue, according to some of the embodiments disclosed herein.

[0024] [Fig. 2B] illustrates an exemplary injection cannula for depositing adipose tissue into a patient, in accordance with some of the embodiments disclosed herein.

[0025] [Fig. 3] illustrates an exemplary decanting stand according to some of the embodiments disclosed herein.

[0026] [Fig. 4] illustrates an exemplary centrifuge according to some of the embodiments disclosed herein.

[0027] [Fig. 5A] illustrates a cross-section of an exemplary collection receptacle, according to some of the embodiments disclosed herein.

[0028] [Fig. 5B] illustrates an exemplary collection receptacle attached to a syringe, according to some of the embodiments disclosed herein.

[0029] [Fig. 5C] illustrates an exemplary collection receptacle detached from a syringe and including a stromal vascular fraction isolated from adipose tissue, in accordance with some of the embodiments disclosed herein.

[0030] [Fig. 6A] illustrates an exemplary 3-way transfer device in accordance with some of the embodiments disclosed herein.

[0031] [Fig. 6B] illustrates exemplary male-female connector covers in accordance with some of the embodiments disclosed herein.

[0032] [Fig. 7] illustrates an exemplary pressure control piston in accordance with some of the embodiments disclosed herein.

[0033] [Fig. 8] illustrates an exemplary method for performing an autologous adipose tissue transplant in a patient, in accordance with some of the embodiments disclosed herein.

[0034] [Fig. 9] illustrates an exemplary image of adipose tissue decanted into a syringe assembly, according to some of the embodiments disclosed herein.

[0035] [Fig. 10] illustrates an exemplary image of centrifuged adipose tissue in accordance with some of the embodiments disclosed herein.

[0036] [Fig. 11] illustrates an exemplary method of transferring an isolated stromal vascular fraction to decanted fat, in accordance with some of the embodiments disclosed herein.

[0037] [Fig. 12] illustrates an exemplary flowchart showing a method for performing an autologous adipose tissue transplant in a patient, according to some of the embodiments disclosed herein.

[0038] [Fig. 13] illustrates another exemplary flowchart showing a method for performing an autologous adipose tissue transplant in a patient, according to some of the embodiments disclosed herein.

[0039] In the figures, similar reference numbers correspond to similar components of the systems, kits and methods, unless otherwise indicated.

[0040] DETAILED DESCRIPTION

[0041] Below, we will detail implementations and embodiments of various aspects and variations of the systems, kits, and methods described herein. While several exemplary variations of the systems, kits, and methods are described herein, other variations of the systems, kits, and methods may include aspects of any of the systems, kits, and methods described herein combined in any suitable manner with combinations of all or some of the described aspects. For clarity and conciseness, features may be described herein as part of the same embodiment or as separate embodiments; however, it will be appreciated that the scope of the disclosure includes embodiments with combinations of all or some of the described features.

[0042] Autologous adipose tissue transplantation, also known as fat grafting, is a procedure that uses a patient's own adipose tissue to increase the volume of targeted areas of the body. For example, adipose tissue can be harvested from an area of ​​the patient that has excess adipose tissue volume, and the extracted adipose tissue can then be processed and deposited in a different area of ​​the patient that is experiencing a volumetric adipose tissue deficit. These procedures can be used for cosmetic applications, such as restoring lost or missing soft tissue volume in the face and body to create a healthier, smoother, and more attractive appearance, or for medical applications, such as reconstructing breasts or other soft tissues after surgical tissue removal.

[0043] In some instances, the extracted adipose tissue can be processed prior to transplantation into the patient. For example, adipose tissue can be processed to isolate adipocytes (e.g., fat or fat cells) from the adipose tissue and / or to isolate a stromal vascular fraction from the adipose tissue. The isolated fat and the stromal vascular fraction can be combined to produce a mixture that can be autologously transplanted into the patient. Mixing the stromal vascular fraction with the patient's fat has been shown to be beneficial in transplant procedures, as the stromal vascular fraction is rich in regenerative cells and can lead to greater graft survival and reduce the risk of nosocomial infections and secondary atrophy of the transplanted tissue. Therefore, increasing the survival rate of the stromal vascular fraction and reducing the risk of contamination is important for the success of autologous transplantation.

[0044] Many conventional methods of performing autologous adipose tissue transplantation require complex and time-consuming processing steps to isolate the fat and stromal vascular fraction from the adipose tissue. For example, isolating the stromal vascular fraction and mixing the patient's fat with the stromal vascular fraction may require removing the extracted adipose tissue from the syringe used to extract the adipose tissue and then transporting the adipose tissue to one or more intermediate receptacles and processing equipment. In some instances, the fat and stromal vascular fraction are then combined in a new syringe for reintroduction into the patient. Transferring adipose tissue between multiple collection, processing, handling, and transplantation receptacles can compromise the viability of the transplanted tissue and increase the risk of microbiological contamination of the tissue through handling and environmental exposure to the adipose tissue.Furthermore, the inefficiency of certain equipment, instruments and accessories used in conventional procedures can compromise the quality of the tissue and the stromal vascular fraction extracted, which can lead to a lower graft survival rate and secondary atrophy of the transplanted tissue.

[0045] Described herein are improved systems, kits, and methods for performing autologous adipose tissue transplantation in a patient. The systems, kits, and methods described in this document, along with associated components (e.g., cannulas, equipment, and consumables), are designed to make the surgical procedure easier and more efficient for a medical team, with fewer transportation steps, less equipment, and reduced risk of contamination during adipose tissue processing. In some examples, unlike existing techniques, adipose tissue may be extracted from the patient in one or more syringes, and the tissue may remain in these same syringes during some or all of the processing steps. Optionally, the tissue may be reintroduced into the patient using the same syringe(s) in which the tissue was extracted.However, in other examples, tissue is transported to collection tubes for processing and additional syringes for reimplantation.

[0046] Various components of the systems and kits can be modified or customized to reduce adipose tissue contamination during adipose tissue processing. For example, syringes may include plungers with removable shafts, where the shaft can be decoupled from a plunger seal to change the plunger and / or remove adipose tissue from the syringe, while maintaining a fluid-tight seal within the syringe volume. One or more collection tubes may be provided with fluid-tight seals with fluid-tight inlet ports to allow insertion and removal of tissue from the tubes without contaminating the tissue. In another example, the collected fat can be transferred to a centrifugable receptacle, such as the collection tube, thus obtaining the stromal vascular fraction in a closed system and avoiding material exposure to the environment.Additionally, centrifuges, decantation frames, and other processing equipment can be modified or customized to be compatible with syringes. When multiple adipose tissue components need to be transferred (e.g., a stromal vascular fraction or isolated fat), transfer can be facilitated with specialized equipment that reduces the risk of contamination during transfer, such as fluid-tight inlet ports on syringes and syringe-compatible transfer devices.

[0047] Various components may also be provided to reduce the risk of compromising adipose tissue viability during tissue extraction and deposition, such as custom syringes, infiltration and collection cannulas, injection cannulas, two-stage locks, transfer devices, pressure control plungers, and other accessories such as sealing caps. Furthermore, the equipment, instruments, and accessories contained in the systems and kits and used by the method may be portable to facilitate transportation and handling of the systems and kits by medical personnel. Furthermore, several exemplary components described herein may be connectable via Luer-Lock connections. TM , so that the components described herein are compatible with each other and with commercially available devices that use Luer-Lock connections TMsimilar. Therefore, the autologous adipose tissue transplantation systems, kits, and methods described here may be more efficient than conventional methods, with a reduced risk of contamination or compromising the viability of the adipose tissue extracted prior to autologous transplantation into a patient. Advantageously, the systems, kits, and methods do not require the use of the collagenase enzyme.

[0048] In some examples, a system is provided. The system may include multiple syringes, such as a first syringe, a second syringe, a third syringe, and / or other syringes. The syringes may be used to extract adipose tissue from a patient, process the adipose tissue, and deposit fat and a stromal vascular fraction into the patient. The following illustrates exemplary syringes of various volumes, and more specifically, multiple Luer-Lock syringes. TM . In some examples, the syringes 100 are Luer-Lock syringes TM or Luer-Lock syringes TMmodified or customized. The inclusion of a Luer-Lock connection TM on one or more of the syringes advantageously allows the syringes to mate with various components to form a fluid-tight seal with the components (e.g., cannulas and transfer devices) to prevent leaks during adipose tissue transfer. In some examples, the syringes 100 are single-use syringes and may be discarded after the autologous tissue transplant or one phase of a transplant procedure has been completed. Additionally, or alternatively, the syringes 100 may be sterilizable, such that they may be used for one or more procedures or one or more phases of an autologous tissue transplant procedure.

[0049] In some examples, each syringe 100 includes a chamber 102 for receiving and containing various tissues and biological products within the syringe, such as adipose tissue from a patient, fat isolated from adipose tissue, a stromal vascular fraction isolated from the tissue, and blood and various other biological products derived from adipose tissue. In some examples, each syringe 100 further includes a distal tip 104. The distal tip 104 includes an opening 105 through which tissue can be received into the syringe chamber 102 or extruded from the syringe chamber. In some examples, the distal tip 104 of the syringe 100 includes threads for attaching various components to the opening, such as one or more cannulas used for parenteral extraction and deposition of tissue into a patient, one or more sealing or transfer devices. In some examples, the threads are compatible with Luer-Lock devices. TM, so that a fluid-tight connection can be formed by threading the threaded distal tip 104 of the syringe with one or more Luer-Lock components TM . In some examples, each syringe 100 further includes a proximal end 106 that includes an opening at the proximal end 107 that allows access to the chamber 102. In some examples, a plunger can be inserted into the opening of the proximal end 107, and longitudinal movement of the plunger within the chamber 102 can be used to adjust the volume within the chamber of the syringe 100.

[0050] As shown in FIGURE 1A, the syringes 100 described herein may have various volumes, such as less than 1 mL, 1 mL, 3 mL, 5 mL, 10 mL, 30 mL, 60 mL, or greater than 60 mL. The volume of a syringe 100 may correspond to a volume of tissue that may be contained within the syringe chamber 102 (i.e., a volume of tissue that may be extracted from a patient and placed into the syringe chamber and / or a volume of tissue that may be deposited from the syringe chamber and placed into the patient). For example, a first syringe may be configured to receive a first amount of adipose tissue, and the volume of the first syringe may be greater than at least the first amount of adipose tissue. Similarly, a second syringe may be configured to receive a second amount of adipose tissue, and the volume of the second syringe may be greater than at least the second amount of adipose tissue.Similarly, a third syringe may be configured to deliver a quantity of processed adipose tissue to the patient, and the volume of the third syringe may be greater than the quantity of processed adipose tissue. Each syringe 100 further includes an inner diameter representing the distance between the inner walls forming the syringe chamber 102, and an outer diameter representing the distance between the outer walls forming the cylindrical exterior of the syringe chamber. In some embodiments, the walls of the chamber 102 include gradations in predetermined volume increments, such as at each volume increment of 0.1 ml, 1 ml, 5 ml, or 10 ml.

[0051] In some examples, the system includes a variety of sealing caps, such as exemplary female sealing cap 120 shown in [figure omitted; refer to image for more information]. In some examples, sealing cap 120 is a conventional or commercially available sealing cap designed to be compatible with various commercially available syringes. Sealing cap 120 may be attached to a distal tip 104 of one or more syringes 100, such as any of the syringes 100, to create a fluid-tight seal to seal opening 105 in the distal tip of the syringe and prevent fluid and tissue from leaking from the syringe chamber 102. Another example of a female sealing cap 120 is attachable to the distal tip 104 of Luer-Lock syringes. TM(e.g., syringes 100 shown in). Female sealing caps 120 may be attached to the distal tip of a syringe 100 by fitting the female sealing cap to the distal end 104 of a syringe, such as by screwing the female sealing cap onto the distal tip 104 or by mechanically securing the sealing cap via a snap. When a sealing cap 120 is attached to the syringe 100, the sealing cap may form a fluid-tight volume within the chamber 102 of the syringe. For example, female sealing caps 120 may be attached to a syringe 100 after adipose tissue has been drawn into the syringe and prior to processing the adipose tissue, e.g., prior to decanting and / or centrifuging the adipose tissue within the first and / or second syringes.

[0052] Returning to, in some examples, each of the syringes 100 includes a plunger 110 that can be actuated to receive tissue and extrude tissue from the volume within the syringe chamber 102. The plunger 110 of the syringe 100 may include a shaft 112 configured to slide longitudinally in and out of a syringe chamber 102 through a proximal end opening 107 in the syringe. The plunger 110 of the syringe 100 may further include a seal 114 coupled to the shaft 112, the seal creating a fluid-tight seal against the inner diameter of the syringe chamber 102 (e.g., against the inner walls of the chamber). In this way, shaft 112 and seal 114 can work together to create a fluid-tight seal that defines a volume within chamber 102 of syringe 100, wherein the volume can be increased or decreased by sliding the plunger longitudinally relative to the syringe chamber.For example, plunger 110 may be actuated by pulling plunger shaft 112 outward relative to chamber 102 of syringe 100 to increase volume within the chamber and create a negative pressure in the chamber that causes tissue to be received into the syringe chamber through distal end opening 105. Conversely, plunger 110 may be actuated by pushing plunger shaft 112 inward relative to chamber 102 of syringe 100 to decrease volume within the chamber and create a positive pressure that expels or injects tissue from the syringe chamber out of the syringe (e.g., from the syringe to a patient or from the syringe to the environment or some other receptacle for receiving the tissue).

[0053] In some examples, actuation of plunger 110 to extract (e.g., aspirate) tissue is facilitated by a 2-step lock on the syringe (e.g., a syringe lock) or a 2-step lock attachable to a syringe, such as exemplary 2-step lock 130 shown in [figure omitted; refer to PDF] . 2-step lock 130 may be used to facilitate aspiration of tissue or fluids (e.g., tissue or fluids from a patient's body) by automatically locking the plunger when a predetermined amount of tissue or fluid has been received by a chamber of the syringe. Advantageously, 2-step lock 140 may allow the syringe user to better control the aspiration of adipose tissue, thereby reducing the risk of patient harm and increasing the accuracy of the volume of adipose tissue aspirated.This may be particularly useful during delicate procedures, such as procedures involving the aspiration of a small or precise amount of adipose tissue (e.g., for autologous facial adipose tissue transplantation). The two-step lock 130 is attachable to a plunger 100, for example, by engaging the two-step lock with a shaft of the plunger. The two-step lock may be configured to stop outward movement of the plunger 110 when a predetermined amount of tissue or fluid has entered the chamber 102 of the syringe 100. In some examples, the two-step lock includes a mid-volume lock. In a mid-volume lock, the two-step lock 130 is configured to engage and lock the plunger 110 when half of the predetermined volume of tissue or fluid has been aspirated into the syringe 100. In some examples, the two-step lock 130 includes a final volume lock.In a final volume lock, the two-stage lock 130 is configured to engage to lock the plunger 110 when the predetermined volume of tissue or fluid has been aspirated into the syringe 100. In some examples, the plunger 110 of the syringe 100 (or a shaft 112 thereof) includes a pressure control plunger, such as the exemplary pressure control plunger 700 described below and shown in.

[0054] In some examples, and as shown in , the shaft 112 of the plunger 110 may be disengaged from the plunger seal 114, such that the plunger may be removed from the syringe 100 by disengaging the shaft from the plunger. Removing the plunger 110 from the syringe 100 may include removing a portion of the plunger 110 (e.g., the shaft 112) from the syringe while another portion of the plunger (e.g., the seal 114) remains within the syringe. For example, in some examples, removing the plunger 110 from the syringe 100 includes disengaging the plunger shaft 112 from the plunger seal 114. The right-hand panel shows an exemplary syringe 100 with a plunger 110 with a shaft 112 and a seal 114, with the shaft coupled to the seal (the connection between the shaft and the seal is shown inside the red box). The left-hand panel shows an exemplary syringe 100 with a plunger 110 with its shaft 112 disengaged from the seal 114 (the seal is shown inside the red box).For example, the shaft 112 of the plunger 110 may be disengaged from the plunger seal 114 by unscrewing the shaft from the seal, and in these examples, each of the shaft and plunger seal may contain threads (e.g., threads compatible with a Luer-Lock connection. TM). In some examples, when the shaft 112 is disengaged from the seal 114, the seal remains within the chamber 102 of the syringe 100 and maintains a fluid-tight seal within the chamber, thereby preventing fluid leaks and spills through the proximal end opening of the syringe when the shaft has been disengaged from the seal. In some examples, the seal 114 is a self-sealing rubber or silicone membrane. Advantageously, maintaining the seal 114 in the chamber 102 of the syringe 100 prevents post-piercing fluid from leaking out of the syringe, thereby minimizing the risk of microbiological contamination of the fluid and / or adipose tissue. Optionally, when plunger 110 has been removed from syringe 100, various other components may be placed over proximal end 106 of the syringe, such as a sealing cap (e.g., sealing cap 140 shown in) or a pressure control plunger (e.g., pressure control plunger 700 shown in).

[0055] In some examples, decoupling shaft 112 from seal 114 reveals a fluid-tight inlet port 116 in seal 114. Fluid-tight inlet port 116 may be a narrow bore that optionally extends through a central point of seal 114. Fluid-tight inlet port 116 may prevent fluid from passing through the inlet port while still allowing a cannula to access chamber 102 of a syringe 100. Fluid and tissue may be aspirated from syringe 100 and injected into syringe 100 via a cannula inserted through fluid-tight inlet port 116 and through seal 114. In some examples, fluid-tight inlet port 116 is self-sealing and formed by a narrow bore in the rubber or silicone membrane of seal 114. In some examples, fluid-tight inlet port 116 is disposed within a threaded portion of the seal 114 (e.g., in the center of a Luer-Lock portion TMof the seal 114 used to couple the shaft of a plunger to the seal). Thus, in some examples, the fluid-tight inlet port 116 is covered by the shaft 112 when the shaft is coupled to the seal 114 and is revealed when the shaft is disengaged from the seal.

[0056] The fluid-tight inlet port 116 may prevent fluid from flowing into and out of the proximal end opening 107 of the chamber 102 of the syringe 100 while the seal is within the chamber, thereby preventing contamination and spillage of the syringe contents when the shaft 112 has been disengaged from the seal 114. In some examples, due to the self-healing characteristics of the seal 114, the fluid-tight inlet port 116 may be substantially sealed when a cannula or some other device is not inserted through the fluid-tight inlet port 116. As seen in , in some examples, the fluid-tight inlet port 116 provides access to the contents within the chamber 102 of the syringe 100 using a needle or cannula inserted through the fluid-tight inlet port (e.g., a needle or cannula connected to a second, third, or additional syringe).Thus, when the shaft 112 has been disengaged from the seal 114, tissue and other contents within the chamber 102, such as an adipose-derived stromal vascular fraction, can be removed from the syringe 100 and / or deposited into the syringe using a needle or cannula inserted through the fluid-tight inlet port 116. As shown in , when the plunger 110 has been removed from the syringe 100, a proximal sealing cap 140 can be coupled to a proximal end 106 of the syringe 100 to seal the opening of the proximal end 107 of the chamber 102 and form a fluid-tight seal. In some examples, the proximal sealing cap 140 is coupled to a proximal opening of the syringe via a fitting with the outer diameter of the syringe.

[0057] In some examples, one or more collection tubes 150 are provided to retain a quantity of adipose tissue during adipose tissue processing. For example, an example of a collection tube 150 is illustrated. In some examples, the collection tube 150 is a cylindrical tube, such as a commercially available cylindrical tube for retaining biological samples such as tissue and fluid. The collection tube may have any desired volume, such as less than 1 mL, 1 mL, 3 mL, 5 mL, 10 mL, 30 mL, 60 mL, or greater than 60 mL. The volume of the collection tubes 100 may correspond to a volume of adipose tissue or its components that may be contained in the collection tube. The collection tubes 150 may include a sealing cap 152, which may seal a mouth of the tube, for example, by screwing the cap onto a threaded portion of the tube.In some examples, the sealing cap 152 creates a fluid-tight seal around a mouth of the collection tube 150 to create a fluid-tight seal that prevents contamination of the collection tube contents. In some examples, the sealing cap 152 of the collection tube 150 includes a fluid-tight inlet port, which may be a self-sealing inlet port similar to the fluid-tight inlet port 116 described with respect to seal 114. The fluid-tight inlet port 154 may prevent fluid from leaking from the contents of the collection tube 150 out of the collection tube while still allowing cannulae to enter the inlet port (e.g., for aspiration and removal of the collection tube contents, such as a stromal vascular fraction isolated from adipose tissue in the collection tube). The fluid-tight inlet port 154 may be included in a rubber or silicone portion of the sealing cap 154.In some examples, the rubber or silicone portion is included in a central region of the sealing cap 152. In some examples, the sealing cap includes a Luer-Lock connection. TM to allow attachment of one or more of the syringes (such as any of the syringes 100 described above with respect to). The Luer-Lock connection TM may include a threaded portion that allows attachment to a threaded distal portion of a syringe to allow direct attachment of the syringe with less risk of contamination when tissue or fluids are transferred from the syringe to the collection tube 150. In some examples, the Luer-Lock connection TM can be used to transfer a quantity of adipose tissue to the collection tube for processing. In some examples, the Luer-Lock connection TM can be used to aspirate a quantity of processed adipose tissue (e.g., a stromal vascular fraction) from the collection tube.

[0058] The first syringe, the second syringe, and / or the third syringe may be attachable to a variety of cannulas for infiltration, collection, and ejection of tissue. For example, FIGS. 2A-2B show various exemplary cannulas (e.g., an aspiration cannula 210 and an injection cannula 220) compatible with the exemplary syringes 100 described above and shown in [figure omitted; refer to ... In some examples, the cannulae may be attached to the distal tip of the syringe by screwing the cannula onto the syringes via threads arranged at the proximal end of the cannula(s) and / or at the distal tip of the syringe(s) (e.g., via a Luer-Lock connection).TM ). When a cannula is connected to a syringe, the material received in the syringe can be received through the hollow body of the cannula, and the material extruded from the syringe can be extruded through the hollow body of the cannula. Thus, the hollow body of the cannula can be in fluid communication with the syringe chamber when the cannula is attached to the syringe. Furthermore, each cannula includes a length corresponding to the length of the cannula and a diameter corresponding to the outer diameter of the cannula. In some examples, the cannulae are made of stainless steel.

[0059] One or more cannulas may be specialized to perform a specific phase of an autologous adipose tissue transplant. For example, an aspiration cannula 210 may be provided for parenterally administering saline to a region of the patient's adipose tissue and / or for extracting adipose tissue from the patient. Figure 2A illustrates several examples of aspiration cannulas 210 for administering saline and / or extracting adipose tissue. As mentioned above, aspiration cannula 210 includes a distal end 212 and a plurality of holes 213 positioned at or near the distal end. In some examples, the diameter of aspiration cannula 210 is about 3 mm. In some examples, the length of aspiration cannula 210 is between about 20 mm and about 22 mm. The plurality of holes 213 in the cannula 210 may be arranged in longitudinal rows spaced around the circumference of the suction cannula.In some examples, holes 213 are disposed at the distal end of cannula 210 (e.g., within 2 cm of the distal tip of the cannula). In some examples, aspiration cannula has about 20 holes. However, aspiration cannula 210 may have more or fewer holes (e.g., fewer than 10 holes, 10 to 20, 20 to 40 holes, or more than 40 holes) so as to extract adipose tissue from the patient at a faster rate or to extract adipose tissue more uniformly or from a larger region of the patient. The diameter of holes 213 may be about 0.5 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, or greater than 3.0 mm. In some examples, the suction cannula 210 is configured to perform fat grafting on a patient's face. In these examples, the diameter of the holes 213 may be approximately 1.0 mm or 1.5 mm.In other examples, the suction cannula 210 is configured to perform fat grafting on a patient's body (e.g., the patient's abdomen, breasts, arms, or legs). In these examples, the diameter of the holes 213 may be relatively larger, e.g., about 1.5 mm, about 2.0 mm, or about 2.5 mm. Advantageously, the suction cannula 210 may be configured to extract adipose tissue without significantly compromising the viability of the extracted tissue. For example, the number of holes 213, the diameter of the holes, the position of the holes, and other aspects of the cannula 210 may be selected such that the pressure applied to the extracted tissue is within a suitable range or is less than a specified threshold pressure.

[0060] An injection cannula 220 is also provided, the injection cannula for parenterally delivering (i.e., injecting) processed adipose tissue (e.g., fat extracted from adipose tissue and / or a stromal vascular fraction) into the patient. Illustrates several examples of injection cannulas 220 for delivering processed adipose tissue. As mentioned above, injection cannula 220 also includes a distal end 222 and a bottom port 223 at or near the distal end. In some examples, the length of injection cannula 220 is less than 5 cm, about 5 cm, about 6 cm, about 7 cm, or no more than 10 cm. In some examples, the length of injection cannula 220 is between 5 cm and 10 cm. In some examples, injection cannula 220 includes a single bottom port located at the distal end of the cannula. The diameter of the bottom hole 223 may be less than 1.0 mm, about 1.0 mm, about 1.5 mm, about 2.0 mm, about 2.5 mm, about 3.0 mm, or greater than 3.0 mm.In some examples, the lower hole 223 is shaped to improve adipose tissue deposition in the patient. For example, in some examples, the lower hole 223 is a shark-head-shaped hole. In some examples, the lower hole 223 has different widths and lengths. For example, the width of the lower hole 223 may be less than 0.5 mm, between 0.5 mm and 0.8 mm, between 0.8 mm and 1.2 mm, between 1.2 mm and 1.5 mm, or greater than 1.5 mm or greater than 1.0 mm. In some examples, the length of the lower hole 223 is less than 3 mm, between 3 mm and 3.5 mm, or greater than 3.5 mm. In some examples, the width of the lower hole is approximately 1 mm. In some examples, the length of the lower hole 223 is approximately 3.3 mm.

[0061] In some examples, the injection cannula 220 is configured to deposit tissue. In some examples, the injection cannula 220 is configured to deposit processed adipose tissue into a patient's face. In these examples, the injection cannula may have a length of about 5 cm and a bottom bore 223 with a diameter of about 1.6 mm; a length of about 10 cm and a bottom bore with a diameter of about 2.5 mm; or a length of about 15 cm and a bottom bore with a diameter of about 3.0 mm. In other examples, the injection cannula 220 is configured to deposit processed adipose tissue into a patient's body. In these examples, injection cannula 220 may have a length of about 20 cm and a bottom bore 223 with a diameter of about 1.5 mm, or a length of about 25 cm and a bottom bore with a diameter of about 3.0 mm. However, other cannula configurations may also be envisioned.Aspects of the injection cannula 220 (e.g., the orientation and size of the hole(s) and the cannula dimensions) may also be selected to decrease the risk of damaging the processed adipose tissue.

[0062] In some examples, the system includes a decantation stand configured to hold a plurality of syringes or collection tubes in a vertical or upright position, e.g., during decantation of adipose tissue, or to support the syringe during other stages of an adipose tissue transplantation procedure. For example, an exemplary decantation stand 300 is shown in [figure omitted; refer to PDF] . The decantation stand 300 may be configured to receive one or more of the first syringe, the second syringe, a third or more syringes (e.g., any of the syringes 100 shown in [figure omitted; refer to PDF] ), or one or more collection tubes via one or more holes 310 in the decantation stand 300. In some examples, the decantation stand 300 includes a platform 320, and the plurality of holes are disposed in the platform 320.In some examples, the platform is held at a specific distance above a surface on which the settling stand 300 has been placed, such as a distance of at least 1 cm, at least 2 cm, at least 5 cm, or at least 10 cm. The diameter of the holes 310 may be approximately equal to the outer diameter of one or more of the syringes or collection tubes, such that the syringes and collection tubes are held at a distance of at least 1 cm, 2 cm, 5 cm, or 10 cm. The collection tubes may be freely slid in and out of the holes of the settling stand 300, and the inner edges of the holes hold the syringes or collection tubes in a vertical or approximately vertical position (e.g., with the distal end of the syringe in a downward position and the proximal end of the syringes facing upward).In some examples, the holes 310 of the decantation stand 300 include holes of various diameters, such as holes of diameters corresponding to the outer diameters of the syringes and collection tubes of the various volumes described above. For example, the decantation stand 300 may include at least a first hole sized to receive a syringe of a first volume and a second hole sized to receive a syringe of a second volume different from the first volume. In some examples, the holes 310 of the decantation stand 300 are arranged in one or more rows on the platform 320. For example, a first row of the platform 320 may include holes configured to hold syringes or collection tubes of a first volume, and a second row may include holes to hold syringes or collection tubes of a second volume.

[0063] The system may further include a centrifuge 400, such as the exemplary rotary centrifuge shown in [figure omitted; refer to ...For example, centrifuge 400 may be operated to isolate a stromal vascular fraction from adipose tissue, or to separate various biological materials present in adipose tissue (e.g., to separate adipocytes, blood, infiltration solution, and other materials from adipose tissue). In some examples, centrifuge 400 is a portable centrifuge (e.g., a lighter-weight centrifuge or some other centrifuge with properties that facilitate transport of the centrifuge).

[0064] Centrifuge 400 may be configured to hold syringes or collection tubes of various shapes, such as any of the syringes 100 described above or the collection tubes 150 described above. In some examples, centrifuge 400 is a conical tube centrifuge configured to receive collection tubes and / or syringes of specific diameter(s), and optionally, collection tubes and / or syringes with a conical or tapered tip. For example, centrifuge 400 may include multiple ports 410 for receiving a plurality of syringes, wherein each of the ports 410 has a diameter approximately equal to the outer diameter of one or more of the syringes. The port 410 of the centrifuge 400 may be sized to fit one or more of the syringes, optionally while other components are attached to the syringes, such as collection receptacles (see, for example, collection receptacle 500 at ), sealing caps (see, for example, sealing caps 120 and 140 at , 1C and 1G), and other components.In some examples, centrifuge 400 may be configured to receive syringes or collection tubes with a plurality of different volumes. However, in general, before centrifugation begins with centrifuge 400, the syringes or collection tubes inserted into the centrifuge must be balanced within the centrifuge (e.g., so that there is an equal weight around the centrifuge). In some examples, centrifuge balancing is facilitated by inserting syringes and / or collection tubes with an equal weight or an equal volume of collected adipose tissue.

[0065] Volume 510 may be accessed through a port 520 at the proximal end of the collection receptacle. In some examples, port 520 includes threads or another attachment mechanism compatible with a Luer-Lock connection scheme. TM , so that the collection receptacle 500 is attachable to the distal tip of a syringe (e.g., any of the syringes 100 shown in the description above).

[0066] The volume 510 of the collection receptacle 500 may be approximately equal to the volume of a stromal vascular fraction isolated from a quantity of adipose tissue contained in a syringe. However, in other examples, the volume 510 of the collection receptacle 500 may be greater than the volume of a stromal vascular fraction isolated from the quantity of adipose tissue, such as about 1.5x the volume of the stromal vascular fraction, about 2x the volume of the stromal vascular fraction, about 3x the volume of the stromal vascular fraction, about 4x the volume of the stromal vascular fraction, or greater than about 4x the volume of the stromal vascular fraction. The dimensions of the collection receptacle 500 may be selected to allow a pellet forming the stromal vascular fraction to be collected in the collection receptacle. For example, an opening of collection receptacle 500 may be at least 1 mm in diameter, at least 2 mm in diameter, at least 3 mm in diameter, or greater than 3 mm in diameter.

[0067] As mentioned above, the collection receptacle 500 may be attachable to a distal end of a syringe, such as a catheter nozzle or a distal opening in the distal end of the exemplary syringes described above and shown in. For example, the collection receptacle 500 may be attached by screwing the collection receptacle to the distal end of the syringe via threads disposed on the collection receptacle (e.g., port 520) and / or the syringe(s). However, in other examples, the collection receptacle 500 or a port 520 of the collection receptacle is attachable to the distal end of a syringe via an engagement with the distal end and / or the distal end opening of the syringe.In some examples, when collection receptacle 500 is attached to a syringe, volume 510 within collection receptacle is in fluid communication with the volume of the syringe (e.g., with a chamber of the syringe and the materials contained therein), such that material flowing through the distal end opening of the syringe or material settling near the distal tip of the syringe may be collected in collection receptacle via port 520. For example, when a syringe containing a quantity of adipose tissue is centrifuged in a centrifuge (e.g., centrifuge 400 shown in Figure 4), the force of the centrifuge may cause a stromal vascular fraction to separate from the adipose tissue and be collected in volume 510 of collection receptacle 500. Sample an exemplary collection receptacle 500 connected to a syringe 100 via a Luer-Lock connection. TMThe adipose tissue within the syringe was centrifuged to separate the materials within the adipose tissue and to isolate a stromal vascular fraction of the adipose tissue in the collection vessel. Figure 5C shows an exemplary collection vessel 500 that was separated from a syringe 100 after isolation of the stromal vascular fraction, showing the stromal vascular fraction collected in the collection vessel (stromal vascular fraction is indicated by the blue arrow). In some examples, the collection vessel is made of materials similar to the syringe material, such as plastic or another polymer.

[0068] In some examples, the system includes a transfer device, such as a Luer-Lock transfer device. TM three-way compatible with various Luer-Lock compatible components TMof the system. For example, an exemplary transfer device 600 is shown in [figure omitted; refer to PDF] . The transfer device 600 may be connected to at least a first syringe, a second syringe, or a third syringe (e.g., any of the syringes 100 described in [figure omitted; refer to PDF] ) and used to transfer various adipose tissue isolates and / or derivatives between the first and second syringes and the third syringe (e.g., transferring components from the first syringe to the second syringe and to the third syringe, or vice versa). In some examples, the transfer device 600 is attachable to a third syringe and may be used to transfer various adipose tissue isolates and / or derivatives from the first and / or second syringes to the third syringe or an additional syringe (or vice versa, e.g., from a third syringe or additional syringe to the first or second syringe).However, in other examples, the transfer device 600 may be a 2-way or 4-way transfer device connectable to two or four syringes and configured to transfer contents between the two or four syringes.

[0069] In some examples, the transfer device 600 is attachable to a distal tip of the first, second, third, and / or additional syringe. For example, the transfer device 600 may include one or more ports 612, 614, 616, each port attachable to the distal tip of a syringe (e.g., with a first port 612 attachable to a first syringe, a second port 614 attachable to a second syringe, and a third port 616 attachable to a third or additional syringe). The transfer device 600 is attachable to the multiple syringes via a Luer-Lock connection. TMat one or more of the ports, for example, by screwing the distal tip of one or more of the syringes to the ports of the transfer device via threads disposed on the syringe(s) and / or the transfer device. Additionally, or alternatively, the transfer device 600 may be attachable to the syringes via a fitting between the distal tip of the syringes and the ports of the transfer device. In some examples, to attach one or more of the syringes to the transfer device, a male-female connection cap may be attached to the distal tip of the syringe(s). An example of a male-female connection cap 610 is shown in.

[0070] When one or more syringes are attached to the transfer device 600, the volume of a chamber of one or more of the syringes (and / or collection device) may be in fluid communication with the volume of the chamber or one or more of the other syringes via the transfer device. The transfer device may then be used to transfer the contents of the syringe to another syringe, e.g., by actuating the plunger of one or more of the syringes to transfer the contents of one or more of the syringes to another syringe. In some examples, the transfer device 600 may first transfer the most distal portion of the contents of the first syringe (e.g., the portion of the syringe contents closest to the distal end opening of the syringe). For example, the transfer device 600 may be used to transfer a quantity of fat into decanted adipose tissue after biologics have been discarded from the adipose tissue.In some examples, transfer device 600 may be used to transfer the stromal vascular fraction. Advantageously, isolating the stromal vascular fraction from a quantity of adipose tissue may cause the stromal vascular fraction to be retracted near a distal tip of the syringe. Thus, after isolating the stromal vascular fraction, the stromal vascular fraction may be retracted at a strategic location for transfer to another syringe via transfer device 600. In some examples, transfer device 600 may be actuated to control the fluid connection between the volume chambers of the various syringes (e.g., so that the direction of transfer of components contained in the various syringes may be controlled by actuation of the transfer device).For example, the transfer device 600 may be actuated to create a fluid connection that allows the contents of a first and / or second syringe to be transferred to a third syringe and / or to create a fluid connection that allows the contents of a first syringe to be transferred to a second syringe. However, the transfer device 600 may be actuated to create any desired fluid connection between the syringes connected to the transfer device.

[0071] In some examples, the system further includes a pressure control plunger attachable to one or more of the syringes for measuring the pressure of the contents within the syringe. For example, an exemplary pressure control plunger 700 is shown in [figure omitted; refer to PDF] . The pressure control plunger 700 may be attachable to any of the syringes described above (e.g., any of the syringes 100 shown in [figure omitted; refer to PDF] ) and may perform functions similar to those of a syringe plunger or a plunger shaft. Thus, the diameter of the pressure control plunger may be approximately equal to the diameter of a syringe plunger and / or approximately equal to the inner diameter of a chamber of one or more of the syringes. In other examples, the pressure control plunger 700 may be attachable to a syringe plunger and may measure pressure without replacing the existing syringe plunger.When the pressure control plunger 700 is attached to a syringe, the pressure control plunger can be actuated to extrude or inject materials from the syringe chamber and / or aspirate or receive materials into the syringe chamber. In some examples, the pressure control plunger 700 can be attached to a syringe by screwing the pressure control plunger to a seal of the syringe via threads disposed on the pressure control plunger and / or the seal of the syringe(s) (e.g., via a Luer-Lock connection). TM ). For example, the pressure control plunger may be attached by threading the pressure control plunger into the same threads used to engage and disengage the plunger shaft, as described above and shown in. In this manner, the pressure control plunger 700 may be attached to one or more of the syringes after disengaging the shaft from a plunger of one or more of the syringes and engaging the pressure control plunger to replace the shaft.

[0072] The pressure control plunger 700 may include a display for displaying the pressure of the syringe contents. For example, the pressure control plunger 700 may display a pressure at which the syringe contents are being extruded from the syringe (e.g., extruded during the deposition of fat and stromal vascular fraction in a patient) or aspirated into the syringe. In this way, the pressure control plunger may facilitate the deposition of tissue into a patient at a relatively constant pressure. For example, the pressure control plunger may include a display and be configured to display a pressure within the syringe chamber on the display. In some examples, the pressure control plunger includes one or more buttons for controlling the pressure control plunger display or other aspects of the plunger.

[0073] In some examples, a kit is provided. The kit may include various tools and components used to perform an autologous adipose tissue transplant in a patient, such as the components described above with respect to the system for performing an autologous tissue transplant and illustrated in FIGS. 1A-1G, 2A-2B, 3, 4, 5A-5C, 6A-6D, and 7. For example, the kit may include various tissue extraction and injection components, such as locking syringes of varying volumes (e.g., Luer-Lock syringes). TM); one or more collection tubes; several cannulas of different diameters and number of openings (e.g., holes), such as infiltration and collection cannulas and injection cannulas; ejector plungers with positive pressure gauges; plunger components with locking and uncoupling systems for attaching and detaching them from syringes. The kit may also include transfer and connection components that can be connected to the tissue extraction and injection components, such as three-way stopcocks, three-way transfer devices, and various sealing caps. The kit may also include processing equipment and components compatible with the above components, such as a centrifuge (e.g., a portable rotary centrifuge) and a decantation stand (e.g., a portable rack to support multiple syringes of varying volumes).In some examples, the kit includes any or all of the components described above relating to the system for performing an autologous tissue transplant in a patient. However, in other examples, a kit may include only single-use items, and certain components may be provided by a user of the method (e.g., the centrifuge). In some examples, various components of the kit (e.g., the syringes, collection tube, sealing caps, transfer devices, and decantation stand) may be sterilized before being included in the kit. In some examples, the kit and / or various kit items are provided in sterile, single-use packaging. For example, single-use items, which may include the syringes, collection tubes, sealing caps, transfer devices, decantation stand, and other components, may be individually packaged within the kit.

[0074] Illustrates an exemplary method 800 for performing an autologous adipose tissue transplant in a patient. The method may be performed using a system or kit for performing an autologous adipose tissue transplant in a patient, such as any of the systems and kits described above and illustrated in FIGS. 1A-1F, 2A-2B, 3, 4, 5A-5C, 6A-6D, and 7. In some examples, the method includes, prior to harvesting the adipose tissue from the patient, preparing an area of ​​the patient's skin, for example, by washing the skin with an antiseptic agent such as chlorhexidine. The area of ​​skin may be located above a region of adipose tissue that will be harvested and used for autologous tissue transplantation, such as an area of ​​the abdomen, face, breasts, legs, arms, or other region of the patient's body with transplantable adipose tissue.

[0075] In some examples, method 800 involves infiltrating a region of adipose tissue with a solution, such as saline. Infiltrating the adipose tissue with the solution may cause the adipose tissue to swell. In some examples, the solution is administered parenterally to the patient using an infiltration cannula, such as the aspiration cannula 210 described above and shown in [figure omitted; refer to original text]. In some examples, the solution contains one or more local anesthetics, such as lidocaine, which may be included in the solution at a concentration of approximately 0.5% relative to the volume of the solution. The solution may also include one or more compounds to reduce bleeding in the adipose tissue, such as epinephrine (e.g., a concentration of 1:500,000 U of epinephrine).In some examples, the volume of solution used for infiltration may be approximately equal to the volume of adipose tissue to be harvested from the patient, such as approximately equal to the combined volume of the first and second adipose tissue quantities described below. In some examples, to optimize the transplant procedure, the cannula used for solution infiltration is the same cannula used for adipose tissue extraction, or is an identical or similarly configured cannula. In these examples, an aspiration cannula may be used for both adipose tissue infiltration and adipose tissue extraction for processing and transplantation.

[0076] As seen in, in some examples, method 800 includes, in step 802, extracting a first quantity of adipose tissue from a patient into a first syringe. In some examples, method 800 further includes, in step 804, extracting a second quantity of adipose tissue from the patient into a second syringe. The first syringe and the second syringe may include any of the exemplary syringes 100 described above with respect to FIGS. 1A-1B. In some examples, the quantity of adipose tissue is extracted from the solution-infiltrated region of the adipose tissue, and optionally, the adipose tissue extraction may be performed with the same aspiration cannula used for infiltrating the tissue with the solution. In some examples, method 800 includes, prior to extracting the quantities of tissue, connecting an aspiration cannula to the first syringe and / or second syringe.In some examples, the aspiration cannula is like any of the exemplary infiltration and extraction cannulae described above with respect to. In some examples, the first quantity of adipose tissue is received into a chamber of the first syringe and / or the second syringe via the first injection cannula. In some examples, the first and / or the second syringe are Luer-Lock syringes. TM and the suction cannula is connected to the first and / or second syringe by a Luer-Lock connection TMIn some examples, extracting the first and second amounts of adipose tissue from the patient comprises actuating a plunger of the first syringe and receiving the first amount of adipose tissue into a chamber of the first syringe, and actuating a plunger of the second syringe and receiving the second amount of adipose tissue into a chamber of the second syringe. In some examples, extracting the adipose tissue is facilitated by a two-step lock on one or more of the syringes and / or a two-step lock attachable to the syringes (e.g., the two-step lock 130 shown in ). In some examples, the first amount of adipose tissue is approximately equal to the second amount of adipose tissue. However, in other examples, the first amount of adipose tissue may be greater than the second amount of adipose tissue (or vice versa).In some examples, the first amount of adipose tissue and / or the second amount of adipose tissue have a volume of less than 0.1 mL, between 0.1 mL and 1 mL, between 1 mL and 3 mL, between 3 mL and 5 mL, between 5 mL and 10 mL, between 10 mL and 20 mL, between 30 mL and 60 mL, about 60 mL, or greater than 60 mL.

[0077] In some instances, a vacuum pump may be used to aspirate a quantity of adipose tissue from the patient. A vacuum pump may be particularly useful when large quantities of adipose tissue are harvested, such as during a large-volume adipose tissue transplant and / or liposuction procedure. However, a vacuum pump can be used to extract any quantity of adipose tissue from the patient. In some instances, the adipose tissue harvested by the vacuum pump is not used for autologous transfer (e.g., because vacuum pumping the tissue may damage the tissue and impede further processing and tissue reimplantation).In some examples, the method may include extracting a first amount of adipose tissue from the patient into a first syringe; extracting a second amount of adipose tissue from the patient into a second syringe; and extracting adipose tissue from the patient using a vacuum pump until the desired amount of adipose tissue has been removed from the patient.

[0078] In some examples, after extracting the first and second amounts of adipose tissue, method 800 includes removing the aspiration cannula from the first syringe and / or the second syringe. In some examples, method 800 includes, after removing the aspiration cannula, attaching a female sealing cap to the first syringe and / or the second syringe, such as the exemplary female sealing cap 120 shown in FIGS. 1A and 1C. In some examples, method 800 further includes removing a plunger from the first syringe and / or the second syringe, such as removing the plunger in the manner described above and shown in the exemplary FIGS. In some examples, removing the plunger includes disengaging the plunger shaft from the syringe plunger seal. In some examples, the seal maintains a fluid-tight seal against the inner diameter of the second syringe after disengaging the shaft from the seal.For example, the seal may remain within the chamber of the second syringe after the shaft is decoupled, thereby maintaining a fluid-tight seal and advantageously reducing the risk of adipose tissue contamination. In some examples, decoupling the shaft from the seal reveals a fluid-tight entry port in the seal, e.g., the entry port through which the needle is inserted. In some examples, the method includes attaching a proximal seal cap to the proximal end of the first syringe / e or the second syringe, such as exemplary seal cap 140 shown.

[0079] After extracting the first quantity of adipose tissue and the second quantity of adipose tissue from the patient, method 800 may include processing the first and second quantities of adipose tissue to isolate the fat and / or a stromal vascular fraction from the first and second quantities of adipose tissue. In some examples, method 800 may include, in step 806, decanting the first quantity of adipose tissue into the first syringe to isolate the fat from the first quantity of adipose tissue. Advantageously, to simplify the procedure and reduce the risk of contamination of the first quantity of adipose tissue, the first quantity of adipose tissue may be decanted into the first syringes, i.e., without transferring the adipose tissue to a separate container for decantation.However, in some examples, prior to processing the first amount of adipose tissue, the adipose tissue is transferred to a collection tube, such as the collection tube 150 described above with respect to. For example, method 800 may include transferring the first amount of adipose tissue to the collection tube. The first amount of adipose tissue may be transferred to the collection tube by injecting the first amount of adipose tissue through a fluid-tight inlet port on the collection tube, which may be included in a sealing cap of the collection tube, using a cannula. In other examples, transferring the first amount of adipose tissue to the collection tube may include attaching the first syringe to the collection tube using, for example, the Luer-Lock connection on the collection tube, and then evacuating the contents of the first syringe (e.g., the first amount of adipose tissue) into the collection tube.

[0080] In some examples, decanting the first amount of adipose tissue isolates the fat from the first amount of adipose tissue, for example, by separating the fat from other components of the extracted adipose tissue. An example of decanting adipose tissue is shown in [figure omitted; refer to PDF]. Decanting the first amount of adipose tissue may involve decanting the first syringe and / or collection tube onto a decanting stand, such as any of the decanting stands 300 described above and shown in [figure omitted; refer to PDF]. In some examples, the first amount of adipose tissue is decanted under gravity. The first amount of adipose tissue may be decanted for a time sufficient for the fat (e.g., adipocytes or fat cells) in the adipose tissue to separate from the blood, infiltrated saline, and other products not desired for transplantation. In some examples, the first amount of adipose tissue is decanted for about 15 minutes to about 30 minutes.However, in other examples, the first batch of adipose tissue is decanted for more than 30 minutes or less than 15 minutes. After the first batch of adipose tissue is decanted, the fat can be isolated and the blood and other products can be discarded. In some examples, the blood and other products can be discarded through a syringe tip, that is, by pressing the plunger to evacuate the blood and other products from the syringe tip, while keeping the decanted adipose tissue inside the syringe.

[0081] In some examples, method 800 further includes, in step 808, transferring the second quantity of adipose tissue to a collection tube. For example, method 800 may include transferring the second quantity of adipose tissue to the collection tube. The second quantity of adipose tissue may be transferred to the collection tube by injecting the second quantity of adipose tissue through a fluid-tight inlet port on the collection tube, which may be included in a sealing cap of the collection tube, using a cannula. In other examples, transferring the second quantity of adipose tissue to the collection tube may include attaching the second syringe to the collection tube using, for example, the Luer-Lock connection on the collection tube, and then evacuating the contents of the second syringe (e.g., the first quantity of adipose tissue) into the collection tube.

[0082] In some examples, for example, when the second quantity of adipose tissue is not transferred to a collection tube, method 800 may include attaching a collection receptacle to the second syringe. For example, the collection receptacle may be the exemplary collection receptacle 500 described above and shown in FIGS. 5A-5C. In some examples, attaching the collection receptacle to the second syringe includes attaching the collection receptacle to a distal tip of the syringe such that a volume in the collection receptacle is in fluid communication with a chamber of the syringe. In some examples, the collection receptacle may be attached to the second syringe by screwing the collection receptacle to the second syringe, for example, via threads on the collection receptacle or the second syringe. For example, the collection receptacle may be attachable to the second syringe via a Luer-Lock connection. TM. Thus, in some examples, method 800 includes, prior to isolating the attachment of the collection receptacle to the second syringe, unattaching the suction cannula from the second syringe and attaching the collection receptacle.

[0083] Advantageously, to expedite the procedure and reduce the risk of contamination of the second quantity of adipose tissue, the stromal vascular fraction can be isolated from the second quantity of adipose tissue while the second quantity of adipose tissue remains within the second syringe, i.e., without transferring the adipose tissue to a separate receptacle for isolation of the stromal vascular fraction. Thus, in some examples, method 800 includes inserting the second syringe containing the second quantity of adipose tissue into a centrifuge, such as ports 410 of the exemplary centrifuge shown in, and centrifuging the second quantity of adipose tissue within the second syringe. In this manner, the centrifuge can be configured to receive the second syringe in the centrifuge ports, optionally with a collection receptacle attached to the distal end of the second syringe and, optionally, including a gasketed sealing cap on the proximal end of the second syringe.In some examples, isolation of the stromal vascular fraction from the second quantity of adipose tissue causes the stromal vascular fraction to be collected in the collection receptacle attached to the distal end of the second syringe, as shown in the example.

[0084] In some examples, method 800 includes, in step 810, isolating a stromal vascular fraction from the second quantity of adipose tissue. In some examples, isolating the stromal vascular fraction from the second quantity of adipose tissue includes using a centrifuge (e.g., centrifuge 400 shown in) to centrifuge the second quantity of adipose tissue in the second syringe and / or collection tube. The tissue may be centrifuged until a stromal vascular fraction is separated from other products in the second quantity of adipose tissue, such as blood, adipocytes, and other biological products. In some examples, the second quantity of adipose tissue is centrifuged with a relative centrifugal force greater than gravity, such as an RCF of approximately 1286 xg (i.e., with a force that is 1286 times the force of gravity). In some examples, the second quantity of adipose tissue is centrifuged for approximately 3 minutes.However, in other examples, the second amount of adipose tissue may be centrifuged at a greater or lesser force (e.g., greater than 1286 x hg or less than 1286 x g) or for a greater or lesser duration (e.g., less than 3 minutes or greater than 3 minutes).

[0085] In some examples, as described above, a collection receptacle attachable to a syringe is not used for collection of the stromal vascular fraction. In these examples, method 800 includes inserting a collection tube containing the second quantity of adipose tissue into a centrifuge and centrifuging the second quantity of adipose tissue within the collection tube(s). For example, in some examples described above, the centrifuge is configured to receive the collection tube, and the second quantity of adipose tissue is centrifuged in the collection tube. In these examples, isolation of the stromal vascular fraction from the second quantity of adipose tissue results in the adipose tissue being collected in a distal portion of the collection tube. Additional examples of isolated stromal vascular fractions near the distal tip of several exemplary collection tubes (the stromal vascular fraction is indicated by the blue arrow) are shown.

[0086] In some examples, after decanting the first quantity of adipose tissue to isolate the fat from the first quantity of adipose tissue and isolating the stromal vascular fraction from the second quantity of adipose tissue, method 800 includes, in step 812, combining the stromal vascular fraction with the fat. In some examples, the stromal vascular fraction and fat are combined in the collection tube. In some examples, the stromal vascular fraction and fat are combined in the first syringe (i.e., the syringe containing the fat isolated from the first quantity of adipose tissue after decanting the first quantity of adipose tissue). In some examples, before combining the stromal vascular fraction with the fat in the first syringe, the waste products are discarded from the syringe so that only the fat remains in the first syringe.For example, in some cases, combining the stromal vascular fraction with fat involves collecting the isolated stromal vascular fraction from the second amount of adipose tissue in the second syringe and depositing the stromal vascular fraction in the first syringe. Advantageously, combining the fat and stromal vascular fraction in the first syringe limits the need to remove fat from the first syringe, reducing the risk of contamination and improving the efficiency of the transplant procedure. However, additionally or alternatively, the stromal vascular fraction and fat can be combined in a third syringe, separate from the first syringe and the second syringe.For example, combining the stromal vascular fraction with fat may involve collecting the isolated fat and stromal vascular fraction from the respective first and second syringes (or a collection tube in which adipose tissue has been processed) and depositing the fat and stromal vascular fraction into a third syringe. In some examples, for example, when the isolated stromal vascular fraction is isolated in the distal portion of the collection tube, combining the stromal vascular fraction with the ventilator involves aspirating the stromal vascular fraction from the collection tube using a cannula (e.g., an injection cannula). In some examples, the stromal vascular fraction is removed through a fluid-tight inlet port on a seal of the collection tube using the cannula.

[0087] As described above, the isolated stromal vascular fraction may be isolated from the second quantity of adipose tissue (e.g., isolated by centrifugation) and collected in a collection vessel attached to the distal end of the second syringe or to the distal portion of a collection tube into which the second quantity of adipose tissue was transferred. In these examples, combining the stromal vascular fraction with the fat may involve collecting the stromal vascular fraction from the collection vessel and depositing the stromal vascular fraction into the first syringe or the third syringe. The stromal vascular fraction may be collected from the collection vessel using a needle inserted into the collection device, as shown in [figure omitted; refer to PDF] . In some examples, collecting the stromal vascular fraction from the collection vessel includes using the needle to mechanically aspirate the stromal vascular fraction from the collection vessel.In some examples, and as seen in, the collection vessel may be removed from the second syringe before collecting the stromal vascular fraction from the collection vessel. However, in other examples, the needle may be used to collect the stromal vascular fraction from the collection vessel while the vessel is connected to the second syringe, for example, by inserting the needle through a fluid-tight inlet port into a seal on the second syringe, as seen in Figure 1E, and withdrawing the stromal vascular fraction from the second syringe through the fluid-tight inlet port. In some examples, the stromal vascular fraction is removed through the fluid-tight inlet port using an aspiration cannula. The stromal vascular fraction may then be deposited into the first syringe to combine the stromal vascular fraction with the fat decanted in the first syringe.However, in other examples, the stromal vascular fraction is deposited into a third syringe different from the first syringe and the second syringe.

[0088] For example, an exemplary schematic showing the combining of the stromal vascular fraction with fat according to an example of method 800 is presented. As seen in the leftmost image of , the stromal vascular fraction (corresponding to the pellets within the syringe) may be positioned within chamber 102 of syringe 100 in or near a collection receptacle 500 attached to the distal end of the syringe. The stromal vascular fraction may be removed from the processed (e.g., centrifuged) adipose tissue in second syringe 100 using a needle inserted through a fluid-tight inlet port 116 in the seal 114 of the syringe. The stromal vascular fraction may then be transferred to chamber 102 of first syringe 100 containing transplantable fat (e.g., decanted adipose tissue with blood and debris removed).As seen in the central image, combining the stromal vascular fraction with fat may involve depositing the stromal vascular fraction through a fluid-tight inlet port 116 into the seal 114 of the first syringe. The first syringe 100 may be attached to an injection cannula 220, which may be used to inject the stromal vascular fraction and transplantable fat into a patient. As shown in the rightmost panel of, a pressure control plunger 700 may be connected to the first syringe 100 after the stromal vascular fraction is transferred to the first syringe to facilitate injection of the stromal vascular fraction and transplantable fat into the patient at a constant pressure.

[0089] Returning to method 800, additionally or alternatively, combining the stromal vascular fraction with fat comprises transferring the stromal vascular fraction using a transfer device, such as the exemplary transfer device 600 described above and shown in [figure omitted; refer to original text]. In these examples, combining the stromal vascular fraction with fat may include attaching each of the first syringe and the second syringe to the transfer device. In some examples, the distal tip of the first and / or second syringe is attachable to the transfer device, such that the transfer device allows a fluid connection between the chambers of the first and / or second syringe and the contents contained therein.In some examples, method 800 further includes, prior to attaching the first and / or second syringe to the transfer device, attaching a male-female connection cap to the first and / or second syringe, such as exemplary male-female connection device 610 shown in [figure omitted; refer to original text]. In some examples, method 800 includes using the transfer device to transfer the stromal vascular fraction from the second syringe to the first syringe. In some examples, method 800 includes using the transfer device to transfer the stromal vascular fraction in the second syringe to a third syringe. In some examples, method 800 includes using the transfer device to transfer the isolated fat from the second decanted amount of adipose tissue in the first syringe to the third syringe.Advantageously, isolation of the stromal vascular fraction may cause the stromal vascular fraction to settle near the distal tip of the second syringe and / or collection tube, facilitating transfer of the stromal vascular fraction through the transfer device.

[0090] Method 800 may further include, in step 814, depositing the fat and stromal vascular fraction into the patient. The fat and stromal vascular fraction may be deposited parenterally into the patient in regions of the patient's body with a volumetric deficit of adipose tissue. In some examples, preoperative markings are made on regions of the patient to indicate areas of volumetric deficit, such as areas of volumetric deficit on the patient's face, and the method includes depositing the stromal vascular fraction and fat into the marked regions of the patient. In some examples, the fat and stromal vascular fraction are deposited into the patient using a multichannel retrograde technique, such that the fat and stromal vascular fraction are homogeneously deposited into multiple subcutaneous layers of the patient under controlled pressure.In some examples, before depositing the fat and stromal vascular fraction into the patient, the fat and stromal vascular fraction are mixed to form a homogeneous mixture. However, in other examples, the fat and stromal vascular fraction do not form a homogeneous mixture before depositing the fat and stromal vascular fraction into the patient.

[0091] The fat and stromal vascular fraction may be deposited into the patient using a syringe attached to an injection cannula configured for adipose tissue deposition (e.g., any of the exemplary injection cannulas 220 described above and shown in ). Thus, in some examples, depositing the fat and stromal vascular fraction into the patient includes attaching an injection cannula to the first syringe and / or the third syringe (e.g., the syringe containing the fat and stromal vascular fraction). In some examples, depositing the fat and stromal vascular fraction into the patient comprises actuating a plunger of the first syringe and / or the third syringe to deposit the stromal vascular fraction and fat into the patient. In some examples, a pressure-control plunger may be used to facilitate the controlled deposition of the fat and stromal vascular fraction into the patient, such as the pressure-control plunger 700 shown in .Accordingly, in these examples, the first and / or third syringes include a pressure control plunger. Method 800 may include attaching a pressure control plunger to the first and / or third syringe. In some examples, attaching the pressure control plunger to the first and / or third syringe comprises screwing the pressure control plunger to the first and / or third syringe via threads disposed on one or more of the pressure control plunger and the first and / or third syringe, e.g., via a Luer-Lock fitting. TM . In these examples, fat and stromal vascular fraction can be deposited into the patient under a relatively constant pressure, which can be monitored using the pressure control plunger.

[0092] In some examples, fat and stromal vascular fractions are deposited into the patient until the adipose tissue volume deficit has been resolved by depositing a sufficient amount of fat and stromal vascular fractions. In some examples, the volume deficit may be greater than the capacity of a single syringe. Thus, in some examples, a plurality of syringes may be used to successively deposit the fat and stromal vascular fraction into the patient. In such cases, the method may include using a plurality of syringes and injection cannulas to deposit the fat and stromal vascular fraction into the patient, wherein each syringe includes a quantity of combined fat and stromal vascular fraction and is used to deposit the fat and a stromal vascular fraction into a region of the patient.

[0093] A flowchart of an exemplary method for performing autologous adipose tissue transplantation in a patient according to method 800 shown in and described above is presented. As shown in, an aspiration cannula 210 is used to withdraw a quantity of adipose tissue from a patient into two syringes 100 (e.g., a first syringe, seen in the lower path of the flowchart, and a second syringe, seen in the upper path of the flowchart). As described in step 802 of method 800, a first quantity of adipose tissue may be withdrawn into the first syringe. As described in step 804 of method 800, a second quantity of adipose tissue may be withdrawn into the second syringe. The first syringe 100 and the first quantity of adipose tissue contained therein may then be placed in a decantation stand 300 and decanted until the adipose tissue has been separated into transplantable fat and waste products, as described in step 806 of method 800.After decanting the first amount of adipose tissue into the first syringe, the waste products can be discarded and the transplantable fat can be retained within the first syringe. Concurrently with processing the first amount of adipose tissue, the second amount of adipose tissue within the second syringe can be processed to isolate a stromal vascular fraction of the adipose tissue. For example, the plunger of the second syringe 100 can be disassembled by removing the plunger shaft 112, leaving a plunger seal 114 within the syringe chamber 100. After removing the shaft 112, a sealing cap 140 can be placed over an opening in the proximal end of the syringe chamber 102, and a collection receptacle 500 can be connected to the distal tip of the second syringe, as described in step 808 of method 800.The second syringe and the second quantity of adipose tissue may then be placed into a receiving port 410 of a centrifuge 400 and centrifuged to isolate a stromal vascular fraction from the second quantity of adipose tissue, as described in step 810 of method 800. After centrifugation, the stromal vascular fraction will be collected in the collection receptacle 500 attached to the distal end of the syringe. The stromal vascular fraction in the second syringe may then be combined with the transplantable fat in the first syringe, as described in step 812 of the method. For example, the stromal vascular fraction and / or the transplantable fat may be combined using, for example, a transfer device to transfer the stromal vascular fraction and / or the transplantable fat between the first and second syringes or to a new syringe.In some examples, the stromal vascular fraction and transplantable fat are combined in the first syringe (e.g., by transferring the stromal vascular fraction from the second syringe to the first syringe using the transfer device), or alternatively, the stromal vascular fraction and transplantable fat may be combined in a third syringe distinct from the first syringe and the second syringe. The syringe in which the stromal vascular fraction and transplantable fat are combined may be equipped with a pressure control plunger 700 and have an injection cannula 220 connected to the distal end of the syringe. Syringe 100 may then be used to deposit the stromal vascular fraction and transplantable fat into a patient as described in step 814 of method 800.However, as mentioned above, in some examples, the stromal vascular fraction and decanted fat are combined in a third syringe, and the third syringe is used to deposit the stromal vascular fraction and fat into the patient. This third syringe may include a pressure control plunger and / or a pressure control plunger may be attached to the third syringe prior to depositing the decanted fat and stromal vascular fraction. The third syringe may be attachable to the injection cannula, and the fat and stromal vascular fraction may be deposited into the patient via the third injection cannula.

[0094] Another flowchart of an exemplary method for performing autologous adipose tissue transplantation in a patient according to the method shown in and described above is presented. The method shown in the flowchart shown in may be generally similar to the method shown in the flowchart shown in, except that the method shown in does not utilize a collection vessel for collecting a stromal vascular fraction. As shown in, an aspiration cannula 210 is used to withdraw a quantity of adipose tissue from a patient into two syringes (e.g., a first syringe, seen in the lower path of the flowchart, and a second syringe, seen in the upper path of the flowchart). As described in step 802 of method 800, a first quantity of adipose tissue may be withdrawn into the first syringe. As described in step 804 of method 800, a second quantity of adipose tissue may be withdrawn into the second syringe.The plungers of the first and second syringes may be removed, for example, by decoupling the shaft 112 from the plunger and leaving a plunger seal 114 within the syringe chamber 100. After the plunger (and / or its shaft 112) has been removed from each syringe, a sealing cap 140 may be placed over an opening of the proximal end of the chamber 102 of each of the syringes. The first syringe (or its capped chamber 102) and the first quantity of adipose tissue contained therein may then be placed in a decantation stand 300 and decanted until the adipose tissue is separated into transplantable fat and waste products, as described in step 806 of method 800. After decanting the first quantity of adipose tissue within the first syringe, the waste products may be discarded and the transplantable fat may be retained within the first syringe.In parallel with processing the first quantity of adipose tissue, the second quantity of adipose tissue within the second syringe may be processed to isolate a stromal vascular fraction from the adipose tissue. For example, the second syringe (or a capped chamber 102 thereof) and the second quantity of adipose tissue may be placed in a receiving port 410 of a centrifuge 400 and centrifuged to isolate a stromal vascular fraction from the second quantity of adipose tissue, as described in step 810 of method 800. After centrifugation, the stromal vascular fraction in the second syringe may then be combined with the transplantable fat in the first syringe, as described in step 812 of the method.For example, the stromal vascular fraction and / or transplantable fat may be combined using, for example, a transfer device to transfer the stromal vascular fraction and / or transplantable fat between the first and second syringes or to a new syringe. In some examples, the stromal vascular fraction and transplantable fat are combined in the first syringe (e.g., by transferring the stromal vascular fraction from the second syringe to the first syringe using the transfer device), or alternatively, the stromal vascular fraction and transplantable fat may be combined in a third syringe, separate from the first syringe and the second syringe. The syringe in which the stromal vascular fraction and transplantable fat are combined may be equipped with a pressure control plunger 700 and have a second injection cannula 220 connected to the distal end of the syringe.Syringe 100 may then be used to deposit the stromal vascular fraction and transplantable fat into a patient as described in step 814 of method 800. Examples:

[0095] Example 1:

[0096] Phase 1 (liposuction):

[0097] With the patient under locoregional anesthesia and light sedation, the adipose tissue can be swelled with a solution collected by the physician using syringes attached to the infiltration / collection cannula. The adipose tissue can then be collected into the syringes, optionally facilitated by a two-step lock attached to the syringe.

[0098] Phase 2 (processing):

[0099] One or more syringes, optionally sealed with a sealing cap, can be kept immobilized in a decantation stand to decant the adipose tissue and separate the fat from the adipose tissue that will be used in fat grafting.

[0100] To isolate a stromal vascular fraction from adipose tissue, another syringe filled with liposuctioned adipose tissue can have its plunger removed, a physician can seal the syringe with the sealing cap, and a collection receptacle can be attached to the distal end of the syringe. This syringe can then be centrifuged in a centrifuge customized to fit the syringe. After centrifugation, the stromal vascular fraction will be retained at the bottom of the syringe (e.g., as shown in FIGS. 5B-5C). The g-force applied by the centrifuge can be set by a physician within the parameters indicated by the centrifuge.

[0101] The stromal vascular fraction present in the syringe can then be separated from the other centrifuged liposuction material by mechanical aspiration, using a suction cannula inserted into a leak-tight inlet port on the syringe seal. Alternatively, because the isolated stromal vascular fraction will be strategically located in the lower portion of the syringe, it can be transferred to another compartment using a transfer device.

[0102] Phase 3 (fat grafting):

[0103] The syringe containing the homogenized stromal vascular fraction and autologous fat will be connected to an ejector cannula. Using a pressure control plunger attached to the syringe, the physician can transfer the syringe's contents to the desired location in a patient.

[0104] Example 2: After antiseptic preparation of the lower abdominal skin with chlorhexidine, a saline solution containing xylocaine (lidocaine) 0.5% and epinephrine 1:500,000 U can be infiltrated into a patient using an infiltration cannula (see, e.g., Condé-Green, A., de Amorim, N.F.G., & Pitanguy, I. (2010). Influence of decantation, washing, and centrifugation on adipocyte and mesenchymal stern cell content of aspirated adipose tissue: a comparative study. Journal of Plastic, Reconstructive & Aesthetic Surgery, 63(8),1375-1381). The infiltrated volume can correspond to half the volume that will be aspirated, and the cannula used for infiltration can be the same one that will be used for adipose tissue harvesting, optimizing the liposuction process. These cannulas can be customized and attached to Luer-Lock syringes. TM. After infiltration, adipose tissue is liposuctioned from the patient using the same infiltration cannula. Tissue aspiration can be performed manually using a two-stage lock or, optionally, with a vacuum pump connected to a collection bottle, depending on the volume aspirated.

[0105] Half of the fat collected during liposuction undergoes a slow gravity decantation process, and after 15 to 30 minutes, a lower layer with blood residue can be discarded. The remaining portion of the fat can be collected in the SVF decoupling syringe, and after removing the plunger in a closed system, the syringe can be centrifuged at 1286 xg for 3 minutes. After centrifugation, the stromal vascular fraction forms a pellet, rich in regenerative cells, which is collected in a syringe collection receptacle or in the distal portion of a collection tube. The stromal vascular fraction can then be transferred to the syringe containing the decanted fat. The pellet obtained from a 10 ml syringe enriches the same volume of fat that underwent the decantation process (see, for example, Gontijo-de-Amorim, NF, Charles-de-Sá, L., & Rigotti, G. (2017).Mechanical supplementation with the stromal vascular fraction yields improved volume retention in facial lipotransfer: a 1-year comparative study.Aesthetic surgery journal,37(9), 975-985).

[0106] After fat enrichment with the stromal vascular fraction, the material can be transferred to one or more syringes that include a pressure-control plunger, and the syringes can be attached to injection cannulas for fat grafting. For fat grafting on the face, three types of cannulas can be used: 1) a 5 cm long cannula with a single 1.6 mm diameter bottom hole; 2) a 10 cm long cannula with a single 2.5 mm diameter bottom hole; 3) a 15 cm long cannula with a single 3.0 mm diameter bottom hole. For fat grafting on the body, three types of cannulas can be used: 1) a 20 cm long cannula with a single 2.5 mm diameter bottom hole; 2) 25 cm long cannula with a single 3.0 mm diameter bottom hole or 3) 15 cm long cannula with a 2.5 mm diameter bottom hole, or 20 cm long cannula with a 3.0 mm diameter bottom hole.If fat grafting is performed on the face, smaller cannulas can be used, such as any of the cannulas described above.

[0107] For fat grafting, preoperative markings can be made on the patient to indicate areas of volumetric deficit. Using the multichannel retrograde technique, fat can be deposited homogeneously in several subcutaneous layers under controlled pressure. Care must be taken to avoid overcorrection, which can influence subsequent evaluations of the grafted area.

[0108] DEFINITIONS

[0109] Unless otherwise defined, all terms of art, notations, and other technical and scientific terms or terminology used in this document should have the same meaning as commonly understood by one skilled in the art to which the claimed subject matter belongs. In some embodiments, terms with commonly understood meanings are defined herein for clarity and / or ready reference, and the inclusion of such definitions in this document should not necessarily be construed as representing a substantial departure from what is commonly understood in the art.

[0110] As used in this document, "Luer-Lock TM "refers to a standardized system of fluid fittings used to create fluid-tight connections between various components that contain fluid or tissue (e.g., syringes, cannulas, and transfer devices for containing or transferring adipose tissue or processed adipose tissue). A Luer-Lock fittingTM The fitting may consist of a male tapered fitting and a corresponding female fitting for mating with the male tapered fitting. Optionally, one or more of the male and female fittings may be threaded, and the fittings may be mated to form a leak-tight connection by screwing the male fitting into the female fitting (or vice versa). In some examples, a threaded collar is provided that can be rotated over the mating male and / or female fittings to form a fluid-tight connection.

[0111] References to "about" a value or parameter in this document include (and describe) variations that are directed to that value or parameter itself. Additionally, references to the phrases "less than," "greater than," "at most," "at least," "less than or equal to," "greater than or equal to," or other similar phrases followed by a sequence of values ​​or parameters are intended to apply the phrase to each value or parameter in the sequence of values ​​or parameters.

[0112] As used in this document, the singular forms "a," "um," and "o" shall also include the plural forms, unless the context clearly indicates otherwise. It should also be understood that the term "and / or," as used in this document, refers to and encompasses any and all possible combinations of one or more of the associated listed items. Furthermore, it should be noted that the terms "includes," "including," "comprises," and / or "comprising," when used in this document, specify the presence of stated resources, integers, steps, operations, elements, components, and / or units, but do not exclude the presence or addition of one or more other resources, integers, steps, operations, elements, components, units, and / or groups thereof.

[0113] This application discloses several numerical ranges in the text and figures. The disclosed numerical ranges inherently support any range or value within the disclosed numerical ranges, including the endpoints, even if a precise range limitation is not stated literally in the specification, as this disclosure can be practiced across all disclosed numerical ranges.

[0114] The above description is presented to enable one skilled in the art to make and use the disclosure, and is provided in the context of a specific application and its requirements. Various modifications to the preferred embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the disclosure. Any of the variations of the various systems, kits, and methods disclosed herein may include features described by any other systems, kits, and methods described herein. Furthermore, any of the methods may be used with any of the systems and kits described herein. Therefore, this disclosure is not intended to limit the embodiments shown, but rather to be given the broadest scope consistent with the principles and features disclosed herein.

Claims

A method for performing an autologous adipose tissue transplant in a patient, the method comprising: extracting a first quantity of adipose tissue from the patient in a first syringe; extracting a second quantity of adipose tissue from the patient in a second syringe; decanting the first quantity of adipose tissue to isolate fat from the first quantity of adipose tissue; transferring the second quantity of adipose tissue to a collection tube; isolating a stromal vascular fraction from the second quantity of adipose tissue, wherein isolating the stromal vascular fraction causes the stromal vascular fraction to be collected in a distal portion of the collection tube; combining the stromal vascular fraction with fat; and depositing the fat and the stromal vascular fraction in the patient. The method of claim 1, wherein the first quantity of adipose tissue is received into the first syringe via a suction cannula attached to the first syringe. The method of claim 1, wherein isolating the stromal vascular fraction from the second quantity of adipose tissue comprises using a centrifuge to centrifuge the second quantity of adipose tissue. The method of claim 3, wherein the collection tube is inserted into the centrifuge. The method of claim 1, wherein the collection tube comprises a seal that creates a fluid-tight seal against an inner diameter of the collection tube, wherein the seal comprises a fluid-tight inlet port. The method of claim 1, wherein combining the stromal vascular fraction with fat comprises transferring the stromal vascular fraction and fat to a third syringe. The method of claim 6, wherein transferring the stromal vascular fraction comprises removing the stromal vascular fraction through the fluid-tight inlet port. The method of claim 7, wherein the stromal vascular fraction is removed through the fluid-tight inlet port using an injection cannula. The method of claim 6, further comprising, prior to depositing the fat and stromal vascular fraction into the patient, attaching a pressure-controlled plunger to the third syringe. The method of claim 6, wherein the third syringe includes a pressure control plunger. The method of claim 1, wherein the fat and stromal vascular fraction are deposited into the patient via an injection cannula attachable to the third syringe. The method of claim 1, wherein the volume of the first amount of adipose tissue is approximately equal to the volume of the second amount of adipose tissue. A system for performing an autologous adipose tissue transplant in a patient, the system comprising a first syringe for extracting a first quantity of adipose tissue from the patient; a second syringe for extracting a second quantity of adipose tissue from the patient; a collection tube configured to receive the first quantity of adipose tissue and further configured to isolate a stromal vascular fraction from the first quantity of adipose tissue, wherein the collection tube includes a seal, and wherein: the seal creates a fluid-tight seal against an inner diameter of the collection tube;the seal comprises a fluid-tight inlet port, isolating the stromal vascular fraction from the second quantity of adipose tissue causes the stromal vascular fraction to be collected in a distal portion of the collection tube, and wherein the stromal vascular fraction can be removed from the collection tube via the fluid-tight inlet port while maintaining the fluid-tight seal of the seal against the inner diameter of the collection tube; a decantation stand for decanting the first quantity of adipose tissue to isolate fat from the first quantity of adipose tissue; a centrifuge configured to receive the collection tube, wherein the centrifuge is operable to isolate a stromal vascular fraction from the second quantity of adipose tissue in the collection tube; and a third syringe for depositing the fat and the stromal vascular fraction into the patient.; The system of claim 13, further comprising a suction cannula attachable to the first syringe, wherein the first quantity of adipose tissue is extracted from the patient by means of the suction cannula. The system of claim 14, further comprising an injection cannula attachable to the third syringe, the injection cannula being different from the aspiration cannula. The system of claim 15, wherein the stromal vascular fraction is removed from the collection tube via the injection cannula. The system of claim 15, wherein the fat and stromal vascular fraction are deposited into the patient via the injection cannula. The system of claim 13, further comprising a transfer device attachable to the first syringe and the third syringe, wherein the decanted fat can be transferred from the first syringe to the third syringe via the transfer device.A kit for performing an autologous adipose tissue transplant in a patient, the kit comprising: a first syringe for extracting a first quantity of adipose tissue from the patient; a second syringe for extracting a second quantity of adipose tissue from the patient; a collection tube configured to receive the second quantity of adipose tissue and further configured to isolate a stromal vascular fraction from the second quantity of adipose tissue, wherein the collection tube comprises a seal, and wherein: the seal creates a fluid-tight seal against an inner diameter of the collection tube;the seal comprises a fluid-tight inlet port, isolating the stromal vascular fraction from the second quantity of adipose tissue causes the stromal vascular fraction to be collected in a distal portion of the collection tube, and wherein the stromal vascular fraction can be removed from the collection tube via the fluid-tight inlet port while maintaining the fluid-tight seal of the seal against the inner diameter of the collection tube; and a third syringe configured to deposit the fat and the stromal vascular fraction into the patient, wherein the fat is isolated from the first quantity of adipose tissue by decanting the first quantity of adipose tissue. The kit of claim 19, wherein the kit further comprises: an aspiration cannula attachable to at least one of the first syringe and the second syringe, the aspiration cannula for extracting at least one of the first quantity of adipose tissue and the second quantity of adipose tissue from the patient. The kit of claim 10, wherein the kit further comprises an injection cannula attachable to the third syringe, the injection cannula for depositing the fat and the stromal vascular fraction into the patient, wherein the injection cannula is different from the aspiration cannula. The kit of claim 21, wherein the injection cannula is configured to remove the stromal vascular fraction from the collection tube through the fluid-tight inlet port. The kit of claim 19, further comprising a pressure control plunger attachable to the third syringe. The kit of claim 19, further comprising a transfer device attachable to the first syringe and the third syringe, wherein fat can be transferred from the first syringe to the third syringe via the transfer device.

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