ADVANCED SPECIFIC HARVEST, CONTAINMENT, AND DEPLOYMENT SYSTEM (ASHCADS)

Abstract

Kits and methods are provided for harvesting samples such as cells or tissue including skin tissue for use in research and therapeutic protocols. Kits and methods for deploying grafts, constructs or other products for therapeutic use are also provided. Use of the kits temporarily preserves the viability and/or function of the sample (such as a tissue sample) and/or therapeutic agent.

Claims

1. A kit for use in harvesting and deploying a tissue sample comprising: an insulated mailer; a temperature tracker; a cooling component; a sterile container; and at least one of a local anesthetic, a vasoconstrictor, an absorbent pack, sterile gloves, a needle driver, an antimicrobial agent, a biopsy device, a skin marking device, and a biohazard bag.

2. The kit of claim 1, wherein the cooling component is at least one of a freezer pack, dry ice, wet ice, and liquid nitrogen.

3. The kit of claim 1, further comprising an irrigation syringe.

4. The kit of claim 1, further comprising a wound dressing.

5. The kit of claim 4, wherein the wound dressing is antimicrobial.

6. The kit of claim 1, wherein the local anesthetic is lidocaine and the vasoconstrictor is epinephrine.

7. The kit of claim 1, wherein the antimicrobial agent is gentamicin.

8. The kit of claim 1, wherein the biopsy device is at least one of a scalpel, a needle biopsy device, a hookwire biopsy device, a photonic needle, a clamp, forceps, micro-scissors, a punch biopsy device, a core biopsy device, a razor, a shave biopsy device, and a cutaneous needle biopsy device.

9. The kit of claim 1, wherein the skin marking device is at least one of a surgical marker, a colorant dispensing syringe, and a temporary skin pattern impressing device.

10. The kit of claim 1, wherein said kit includes a plurality of the local anesthetic, the vasoconstrictor, the absorbent pack, sterile gloves, the needle driver, the antimicrobial agent, the biopsy device, the skin marking device, and the biohazard bag.

11. The kit of claim 1, further comprising a skin preparation agent.

12. The kit of claim 1, further comprising a geographical locating device.

13. The kit of claim 1, further comprising an environmental monitoring device with or without remote and distant data transmission and storage capabilities.

14. The kit of claim 1, further comprising antimicrobial monitoring.

15. The kit of claim 1, further comprising a security feature.

16. A method of harvesting a skin tissue sample, comprising providing a kit having an insulated mailer; a temperature tracker; a cooling component; a biohazard bag; a biopsy device; a local anesthetic; and at least one of a vasoconstrictor, an absorbent pack, sterile gloves, a needle driver, an antimicrobial agent, and a skin marking device; cleaning the skin; injecting an effective amount of the local anesthetic to produce a insensate skin area; biopsying the skin at a target site within the insensate skin area using the biopsy device; excising the biopsy to provide a tissue sample; and placing the tissue sample in the insulated mailer.

17. The method of claim 16, wherein the cooling component is at least one of a freezer pack, dry ice, wet ice, and liquid nitrogen.

18. The method of claim 16, wherein the biopsy device is at least one of a scalpel, a needle biopsy device, a hookwire biopsy device, a photonic needle, a clamp, forceps, micro-scissors, a punch biopsy device, a core biopsy device, a razor, a shave biopsy device, and a cutaneous needle biopsy device.

19. The method of claim 16, wherein the skin marking device is at least one of a surgical marker, a colorant dispensing syringe, and a temporary skin pattern impressing device.

20. The method of claim 16, wherein said kit includes at least one of an irrigation syringe, a wound dressing, and a skin preparation agent.

Description

BRIEF DESCRIPTION OF DRAWING

[0043] In order that the advantages of the invention will be readily understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments that are illustrated in the appended drawing. Understanding that this drawing depicts only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawing, in which:

[0044] FIG. 1 depicts an exemplary kit disclosed herein.

DETAILED DESCRIPTION OF THE INVENTION

[0045] Disclosed herein are kits and methods that provide samples such as tissue samples or cellular material for experimental, commercial and/or therapeutic protocols. In one embodiment, the kits and methods of the present invention facilitate extraction of skin tissue from a donor which is then used in preparing a graft for skin restoration.

[0046] The kits and methods of the present invention can be used in a range of surgical, medical, cosmetic, research, commercial, agricultural, military, and aerospace applications, to restore or repair cells and/or tissue, to treat or eradicate disease, to create new food sources, to grow and engineer agriculture, to weaponize living materials, and to treat disease or injury in humans and animals distant from Earth (e.g. space station, space shuttle, moon, other planet, etc.).

[0047] In order to facilitate the understanding of the present invention in reviewing the drawings accompanying the specification, reference numerals are provided below. It is noted that the drawings are exemplary only.

REFERENCE NUMERALS

[0048] 10 Kit [0049] 12 Box [0050] 14 Insulated mailer [0051] 16 Temperature tracker [0052] 18 Cooling component [0053] 20 Biohazard bag [0054] 22 Local anesthetic [0055] 24 Vasoconstrictor [0056] 26 Absorbent pack [0057] 28 Sterile gloves [0058] 30 Forceps [0059] 32 Scissors [0060] 34 Needle driver [0061] 36 Antimicrobial agent [0062] 38 Scalpel [0063] 40 Skin marking device [0064] 42 Irrigation syringe [0065] 44 Wound dressing

I. Definitions

[0066] As used herein, the singular forms a, an, or, and the include plural referents unless the context clearly dictates otherwise.

[0067] The term allogenic as used herein refers to cells or tissue from different subjects of the same species.

[0068] The term autologous as used herein refers to cells or tissue from the same subject.

[0069] The terms biological sample, tissue sample, or simply sample as used herein refers to a collection of cells or tissue obtained from a tissue, tissues, organ, or organs of a subject. In certain embodiments, the biological sample is a skin biopsy sample.

[0070] The term biopsy cavity as used herein refers to the void in the subject's tissue after a tissue sample is removed.

[0071] The term biopsy device as used herein refers to any apparatus which can be used to conduct a biopsy procedure. A biopsy device may be a disposable biopsy device or a biopsy device that includes a disposable portion and a non-disposable portion, where the disposable portion comprises a tissue cutting surface.

[0072] The term comprising as used herein is intended to mean that the compositions and methods include the recited elements, but not excluding others. Consisting essentially of when used to define compositions and methods, shall mean excluding other elements of any essential significance to the combination. For example, a composition consisting essentially of the elements as defined herein would not exclude other elements that do not materially affect the basic and novel characteristic(s) of the claimed invention. Consisting of shall mean excluding more than trace amount of other ingredients and substantial method steps recited. Embodiments defined by each of these transition terms are within the scope of this invention.

[0073] The term donor as used herein is taken to mean a subject in which a tissue sample is removed or derived. In one embodiment, the donor will be the same subject as the recipient, i.e., the cell or tissue is autologous. In another embodiment, the donor will be a different subject than the recipient, i.e., the cells or tissues are allogenic.

[0074] The term graft as used herein refers to any free (unattached) cell, tissue, or organ for transplantation.

[0075] The term harvest is used to refer to obtaining a sample such as obtaining a blood or tissue sample from a subject.

[0076] The term local anesthetic as used herein refers to a medication that causes reversible absence of sensation (e.g., pain, pressure, proprioception, etc.). It may optionally include a vasoconstrictor.

[0077] The term needle driver (also referred to as needle holder) as used herein refers to a surgical instrument, used by medical personnel to hold a suturing needle for closing wounds during suturing and surgical procedures.

[0078] The term structural and functional characteristics of a native tissue refers to the anatomical (structural) and physiological (functional) characteristics of an intact (i.e., not damaged, failing or deficient) native tissue in vivo.

[0079] The term subject as used herein refers to a mammal, including human and non-human animals.

[0080] The term proliferation as used herein refers to means to growing or multiplying by producing new cells.

[0081] The term recipient as used herein refers to the subject to which a cell or tissue is administered (e.g., transplanted).

[0082] The term restore or restoration as used herein refers to any qualitative or quantitative improvement in a target such as in a predetermined tissue or and/or site of treatment observed upon implantation of a cells or tissues.

[0083] The term tissue as used herein refers to biological tissues, generally defined as a collection of interconnected cells that perform a similar function within an organism. The tissue may be, for example, epithelium, connective tissue, adipose tissue, muscle tissue, bony tissue, nervous tissue, or tissue from hollow or solid organs. In certain embodiments, the tissue is skin.

[0084] The term vasoconstrictor as used herein refers to an agent that contracts the smooth muscle in blood vessels, which causes the vessels to constrict. Representative, non-limiting vasoconstrictors include alpha-adrenoceptor agonists and vasopressin analogs.

[0085] The term xenogeneic as used herein refers to cells or tissue from a different species.

II. Kit

[0086] In one aspect, the present invention is a harvesting kit for samples such as cell, tissue, blood, blood-derivative, or body fluid samples. Certain components of the harvest kit are used for transporting a sample (e.g., tissue sample) to a second location, e.g., a location where the sample is used for research or further processed to provide a therapeutic agent (e.g., a graft or construct).

[0087] In another aspect, the present invention is a deployment kit such as for deployment of a therapeutic agent formed from a cell, tissue, blood, blood-derivative, or body fluid sample (e.g., a graft, construct or other product). The deployment kit is used to transport agents such as a therapeutic agent to a second location, e.g., a location where a therapeutic agent is used to treat a recipient. In a particular embodiment, the therapeutic agent is an autologous cutaneous construct that arrives at the second location as a semi-liquid homologous suspension or a semi-liquid suspension in a sterile and transparent syringe with plunger.

[0088] In the case of a cell, tissue, blood, blood-derivative, or body fluid sample, the sample is obtained from a donor. The donor may be any suitable donor. In a particular embodiment, the donor is a human donor. In another embodiment, the donor is the same human subject as the recipient, i.e., the cells, tissue, blood, blood-derivative, or body fluid are autologous. In a further embodiment, the donor is a different human subject than the recipient, i.e., the cells, tissue, blood, blood-derivative, or body fluid are allogeneic. In yet another embodiment, the donor is a different species than the recipient, i.e., the cells, tissue, blood, blood-derivative, or body fluid are xenogeneic.

[0089] The kit of the present invention may also include, alternatively or in combination one or more: insulated mailers or environmentally controlled shipment packages, temperature trackers, cooling components, biohazard bags, irrigation syringes, local anesthetics, vasoconstrictors, absorbent packs, sterile gloves, forceps, scissors, needle drivers, antimicrobial agents, biopsy devices, skin marking devices, labels, dressings and/or suture. In certain embodiments, the kit may contain more than one of the referenced components. For example, the kit may contain more than one biopsy device, label, biohazard bag or dressing.

[0090] An exemplary kit 10 is shown in FIG. 1. The kit 10 of FIG. 1 includes a box 12 for holding the various components of the kit 10. The kit 10 further includes an insulated mailer 14, a temperature tracker 16, a cooling component 18, a biohazard bag 20, a local anesthetic 22, a vasoconstrictor 24, an absorbent pack 26, sterile gloves 28, forceps 30, scissors 32, a needle driver 34, an antimicrobial agent 36, a scalpel 38, a skin marking device 40, an irrigation syringe 42, and a wound dressing 44.

[0091] The syringes in the kit may be made of plastic or the like, and have various volumes. In exemplary embodiments, the syringe is a 60-cc syringe. In another embodiment, the syringe is a 30-cc syringe.

[0092] In one embodiment, the kit contains at least one local anesthetic. Local anesthetic anesthetics block the generation and the conduction of nerve impulses. The local anesthetic may be short acting (about 45 minutes to about 90 minutes), intermediate duration (about 90 minutes to about 180 minutes) or long acting (about 4 hours to about 18 hours).

[0093] The local anesthetic may be provided in a vial filled with the local anesthetic solution and an appropriately sized syringe (e.g., 10 cc syringe) and needle(s) (e.g., an 18-guage needle for withdrawing the solution and a 30-gauge needle for injecting the solution).

[0094] The concentration of the solution may vary. In one embodiment, the concentration of the solution is about 0.1%, about 0.15%, about 0.2%, about 0.25%, about 0.3%, about 0.35%, about 0.4%, about 0.45%, about 0.5%, about 0.55%, about 0.6%, about 0.65%, about 0.7%, about 0.75%, about 0.8%, about 0.85%, about 0.9% or about 0.95% or about 1.0% or greater.

[0095] In another embodiment, the concentration of the solution is about 1.0%, about 1.5%, about 2.0%, about 2.5%, about 3.0%, about 3.5%, about 4.0%, about 4.5% or about 5.0% or greater.

[0096] Alternatively, local anesthetic may be provided as a topical formulation. In another embodiment, the local anesthetic is provided in the form of a patch.

[0097] In certain embodiments, the local anesthetic is prepared for use in iontophoresis.

[0098] The local anesthetic may be an amino-amide (amide-type) or an amino-ester (ester-type) local anesthetics. Representative, non-limiting examples of amide-type local anesthetics include lidocaine, mepivacaine, prilocaine, bupivacaine, etidocaine, ropivacaine and levobupivacaine. Articain is also typically considered an amide-type.

[0099] In a particular embodiment, the local anesthetic is lidocaine. In a particular embodiment, the local anesthetic is lidocaine prepared as an injectable solution, e.g., in a vial filled with lidocaine. In a particular embodiment, the injectable solution contains lidocaine in an amount from 1% to 5%, and more particularly, about 1%, about 1.5%, about 2%, about 2.5%, about 3%, about 4% or about 5%. The dose of lidocaine may vary and is to be used at the discretion of the provider.

[0100] In exemplary embodiments, the local anesthetic is lidocaine-HCL. In a particular embodiment, the local anesthetic is XYLOCAINE

[0101] In a particular embodiment, the local anesthetic is bupivacaine. In a particular embodiment, the bupivacaine is 0.25% bupivacaine or 0.50% bupivacaine prepared as an injectable solution. The dose may vary and is to be used at the discretion of the provider.

[0102] In exemplary embodiments, the local anesthetic is bupivacaine-HCL. In a particular embodiment, the local anesthetic is MARCAINE.

[0103] In one embodiment, the local anesthetic comprises two or more amide-type local anesthetics. In a particular embodiment, the local anesthetic comprises lidocaine and bupivacaine.

[0104] Representative, non-limiting examples of ester-type local anesthetics include chloroprocaine, procaine, tetracaine, benzocaine and salts thereof.

[0105] The local anesthetic may be combined with a vasoconstrictor, for example epinephrine. Addition of a vasoconstrictor may beneficially decrease in the peak plasma concentration of the local anesthetic agent, increase the duration and the quality of anesthesia, reduce of the minimum concentration of anesthetic needed for nerve block and/or decrease of blood loss during surgical procedures

[0106] In exemplary embodiments, the local anesthetic is lidocaine-epinephrine or XYLOCAINE-epinephrine. In a particular embodiment, the ratio of epinephrine is 1:100,000 or 1:200,000. The dose may vary and is to be used at the discretion of the provider.

[0107] In exemplary embodiments, the local anesthetic is bupivacaine-epinephrine or MARCAINE-epinephrine. In a particular embodiment, the ratio of epinephrine is 1:100,000 or 1:200,000. The dose may vary and is to be used at the discretion of the provider.

[0108] Optionally, one or more additives may be included in the local anesthetic prepared for injection. In a particular embodiment, sodium bicarbonate is included in the local anesthetic.

[0109] The dressing may be any suitable dressing. In one embodiment, the dressing is impregnated with at least one antimicrobial. The dressing may be, for example, a gauze or bandage, naturally-occurring, synthetic, or semi-synthetic compound or composition or mixture thereof. In a particular embodiment, the antimicrobial is selected from the group consisting of iodine, silver, honey or methyl blue. In a particular embodiment, the dressing is occlusive, nonadherent, and nonporous. In an exemplary embodiment, the antimicrobial dressing is an ioban dressing. In an exemplary embodiment, the dressing is a silicone dressing.

[0110] The biopsy device may be any suitable biopsy device, based on the method utilized. In one embodiment, the biopsy device is selected from the group consisting of a scalpel blade, a needle biopsy device, hookwire biopsy device, photonic needle, clamp, forceps, micro-scissors, punch biopsy device, core biopsy device, razor, shave biopsy device, a cutaneous needle biopsy device. In one embodiment, the biopsy device is a disposable biopsy device. In some embodiments, more than one disposable biopsy device is provided, e.g., one, two, three, four or more disposal biopsy devices. In another embodiment, the kit includes a disposable attachment for a non-disposable biopsy device. In some embodiments, the biopsy device includes blood collection needles, blood collection tubes, a tourniquet, and a syringe.

[0111] In an exemplary embodiment, the biopsy device is a scalpel. The skin marking device may be any suitable skin marking device. In one embodiment, the skin marking device is a surgical marker. In another embodiment, the skin marketing device is a syringe which dispenses a colorant to give a visual indication on the surface of the skin of the point at which an injection has or will be given. In a further embodiment, the skin marking device is a device which has patterning elements for impressing a temporary mark on the surface of the skin.

[0112] The label may be any suitable label. In certain embodiments, the kit contains multiple labels. The labels may be marked, for example, with a patient identification number (PIN). In certain embodiments, the labels ensure sample and therapeutic agent traceability to ensure donor and recipient identification. In certain embodiments, the labels may be marked with de-identified donor and recipient tracking information. In certain embodiments, the de-identified donor and recipient tracking information may be marked on the labels with other transport tracking labels and numbers in order to geolocate donor and recipient specific samples and therapeutic agents in real-time.

[0113] Optionally, one or more additional components may be included in the kit.

[0114] In one embodiment, the kit further comprises a skin preparation agent. In one embodiment, the skin preparation is an antiseptic selected from isopropyl alcohol, povidone-iodine solution, or chlorhexidine.

[0115] In another embodiment, the kit further comprises a sterile container for storing the tissue sample. The container may include a label and identifying information such as a bar code.

[0116] In another embodiment, the kit further comprises forceps.

[0117] In a further embodiment, the kit further comprises a hemostatic agent.

[0118] In certain embodiments, the kit is expressly adapted to enable a harvested tissue sample to arrive at a remote location in a minimally altered or substantially pristine state (e.g. minimally altered by the environmental effects that could otherwise alter the tissue sample). In certain embodiments, the kit further includes means for remote monitoring and communication (such as an audio/video transponder means for immediate real-time audio and video communication between a kit user and product support personnel) with the kit and more especially real-time monitoring of various trackable data of the kit. For instance, the kit may include a GPS transponder chip to enable the real-time location tracking of the kit. Further, sensors and means to transmit sensed data such as kit temperature, kit temperature changes, kit loading (e.g. shock, vibration, and impact loading (e.g. from the kit being dropped), kit spatial positioning (e.g. kit is positioned sideways or upside down), and atmospheric sensing (e.g. oxygen, nitrogen, and other gas levels, moisture/desiccation levels, barometric pressure, altitude). Further the kit may include microbial monitoring and microbial control means. The kit may also include personal protective equipment such as a lab coat, safety glasses, and a mask. In certain embodiments, the kit includes physical and/or digital security features (including for instance biometric locks), traceability features (including for instance biometric traceability), tamper prevention features (for instance a mechanical key or combination lock), and tamper evident features (such as tamper evident security tape). In some embodiments the kit includes organic samples. In other embodiments, the kit includes inorganic samples. In still further embodiments, the kit contains no samples (but is adapted to be used for collecting, storing, transporting, or deploying a sample).

III. Methods of Use

[0119] In one aspect, the present invention is a method of harvesting samples such as harvesting cell, tissue, blood, blood-derivative, or body fluid samples using the disclosed harvesting kit.

[0120] The cells or tissues may be harvested by any suitable method. In one embodiment, the cells or tissue are harvested by biopsy. The biopsy method may be any suitable method, based on the desired size and/or components of the sample. In one embodiment, the biopsy method is an open biopsy. In another embodiment, the biopsy method is a percutaneous biopsy.

[0121] In one embodiment, the tissue is skin. In an exemplary embodiment, the method comprises (i) cleaning the skin; (ii) injecting an effective amount of local anesthetic (e.g., lidocaine-epinephrine) into a target site to produce an insensate area of the skin; (ii) biopsying the skin within the numb area using a scalpel or skin punch; (iv) excising the biological sample to provide a tissue sample and a tissue cavity; (iv) placing the tissue sample in a specimen container; (v) closing the tissue cavity with suture to provide a biopsy site; and (vi) dressing the biopsy site with appropriate dressings.

[0122] In one embodiment, the method further comprising placing the specimen container within the biohazard bag then placing the biohazard bag in the insulated mailer, together with the cooling component.

[0123] In one embodiment, the skin biopsy is partial. In another embodiment, the skin biopsy is full thickness.

[0124] In an exemplary embodiment, skin biopsy is a full-thickness skin biopsy with a minimum surface area of 2 cm.sup.2. In an exemplary embodiment, skin biopsy is a full-thickness skin biopsy with a minimum surface area of 1 cm.sup.2.

[0125] In one embodiment, a full-thickness skin excisional biopsy is harvested in a manner that is consistent with current clinical standard of care utilizing the materials provided in the kit. In another embodiment, the sample of skin is excised by a biopsy technique selected from punch or excisional techniques.

[0126] Excisional Biopsy.

[0127] In an exemplary embodiment, the biopsy technique is excisional. In one embodiment, the excisional biopsy technique is elliptical excision. In one embodiment, the excisional biopsy is accomplished using a scalpel, forceps, and/or scissors. The excisional biopsy captures the full-thickness of the skin including the epidermis, dermis, and partial to complete layers of the hypodermal fat.

[0128] In an exemplary embodiment, the skin biopsy is an excisional, full-thickness skin biopsy with a minimum surface area of 1 cm.sup.2. In an exemplary embodiment, the skin biopsy is an excisional, full-thickness skin biopsy with a minimum surface area of 1 cm.sup.2. In a particular embodiment, the skin biopsy is an excisional, full-thickness skin biopsy with a surface area of about 1 cm.sup.2, about 2 cm.sup.2, about 3 cm.sup.2, about 4 cm.sup.2, about 5 cm.sup.2, or greater than about 5 cm.sup.2.

[0129] Punch Biopsy.

[0130] In an exemplary embodiment, the biopsy technique is punch biopsy. A punch biopsy will provide a full-thickness biopsy of skin ranging in diameter from 2- to 10-mm, based on the size of the punch biopsy instrument. The punch biopsy yields a cylindrical core of tissue that includes the epidermis, the dermis and the subcutaneous tissue. In a particular embodiment, the punch biopsy provides a full-thickness cylindrical core of skin about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9 or about 10 mm in diameter.

[0131] Excisional and/or punch biopsy tissue cavities can be closed, if required at the discretion of the provider, with suture using a needle driver, forceps, and/or scissors contained within the harvesting kit.

[0132] In another embodiment, the biopsy is a core needle biopsy that removes cells as well as a small amount of the surrounding tissue.

[0133] Advantageously, utilizing the kit increases the efficiency of obtaining a sample such as a tissue specimen and/or transporting it to the second location. In certain embodiments, utilizing the kit decreases the risk of contamination of the sample.

[0134] In another aspect, the present invention is a method of preserving and optionally transporting the sample such as cells or tissues to a second location. The kits disclosed herein advantageously preserves viability of the transported sample. As use used herein, the term viability means that after storage and/or transport, the sample functions for its intended purpose such as in the case of a tissue sample the cells are alive and capable of the same functions in existence prior to storage.

[0135] In some embodiments, the cells retain greater than 70% of the viability of the initial population after storage and/or transport.

[0136] In one embodiment, the harvest kit is received at the second location for use within 24, 48 or 72 hours of the harvest.

[0137] In one embodiment, a tissue sample is placed into a sterile container, which optionally contains transport medium or crystalloid solution, and optionally antibiotic, and then placed within two biohazard bags, one with an absorbent pad, for shipping, optionally together with the cooling component (e.g., freezer pack, dry ice, wet ice, or liquid nitrogen), to maintain the contents at a suitable temperature. In exemplary embodiments, the suitable temperature is above freezing. In one embodiment, the suitable temperature is about 4 C. The temperature tracker may be used to ensure that the temperature remains within a suitable range. The cooling system may be designated for overnight shipping, for both the transport of a tissue sample after harvest and transport of a tissue sample derived graft for deployment, as part of the deployment box, e.g., FedEx (or like carrier) priority overnight (before 10 am the next day) or first overnight (before 8 am the next day).

[0138] The sample such as a tissue sample or cells are suitable for use in research and certain protocols such as therapeutic protocols.

[0139] In one embodiment, the method further comprises processing a tissue sample obtained to provide a therapeutic agent, e.g., a graft, construct or other product. The therapeutic agent may be autologous, allogenic, or xenogeneic.

[0140] The methods of processing a tissue sample include any suitable method. In a particular embodiment, the methods of processing are cGTP. In a particular embodiment, the methods of processing are cGMP. In a particular embodiment, the methods of processing are cGLP.

[0141] In one embodiment, a tissue sample is tested pre-processing and shown to be free of bacterial and fungal pathogens. Certain non-pathogenic skin bacteria may be present.

[0142] In one embodiment, the therapeutic agent is tested post-processing and shown to be free of bacterial and fungal pathogens. Certain non-pathogenic skin bacteria may be present.

[0143] In a particular embodiment, a tissue sample is completely processed within 24 or 48 hours of receiving the harvest kit.

[0144] In one aspect, the present invention is a method for deploying a therapeutic agent formed from a harvested tissue sample using the deployment kit.

[0145] The deployment kit contains at least one therapeutic agent. The agent may be an autologous, allogenic or xenogeneic therapeutic agent. In a particular embodiment, the therapeutic agent is an autologous graft, construct or other product. In another particular embodiment, the therapeutic agent is an allogenic graft, construct or other product.

[0146] In a particular embodiment, the therapeutic agent is a fully autologous, homogenous cutaneous construct for reconstruction and/or regeneration of skin. It may be used as an adjunct and/or in place of split-thickness skin grafting, full-thickness grafting, temporizing skin coverage and/or skin substitute products.

[0147] The deployment kit may contain a cooling component and at least one biohazard bag. In a particular embodiment, the deployment kit contains a cooling component and with (3) additional sequential barrier bags.

[0148] In a particular embodiment, the construct is applied or deployed into a target site (e.g., wound bed) that has been properly treated (such as by a medical professional). The treatment may include debriding, excision, sterile preparation and/or cleaning.

[0149] In one embodiment, the deployment kit is received at the second location for therapeutic use within 48 hours or 72 hours from the time the biopsy was obtained.

[0150] Disclosed herein is a kit for use in harvesting and deploying a tissue sample comprising: an insulated mailer; a temperature tracker; a cooling component; a sterile container; and at least one of a local anesthetic, a vasoconstrictor, an absorbent pack, sterile gloves, a needle driver, an antimicrobial agent, a biopsy device, a skin marking device, and a biohazard bag.

[0151] In embodiments, the cooling component is at least one of a freezer pack, dry ice, wet ice, and liquid nitrogen. In embodiments, the kit further comprises an irrigation syringe. In embodiments, the irrigation syringe is a 30 cc irrigation syringe. In embodiments, the kit further comprises a wound dressing. In embodiments, the wound dressing is silicone. In embodiments, the wound dressing is antimicrobial. In embodiments, the local anesthetic is lidocaine and the vasoconstrictor is epinephrine. In embodiments, the antimicrobial agent is gentamicin. In embodiments, the biopsy device is at least one of a scalpel, a needle biopsy device, a hookwire biopsy device, a photonic needle, a clamp, forceps, micro-scissors, a punch biopsy device, a core biopsy device, a razor, a shave biopsy device, and a cutaneous needle biopsy device. In embodiments, the skin marking device is at least one of a surgical marker, a colorant dispensing syringe, and a temporary skin pattern impressing device. In embodiments, the biohazard bag is a UN3373 biohazard bag. In embodiments, the kit includes a plurality of the local anesthetic, the vasoconstrictor, the absorbent pack, sterile gloves, the needle driver, the antimicrobial agent, the biopsy device, the skin marking device, and the biohazard bag. In embodiments, the sterile container is a 50 cc conical tube. In embodiments, the kit further comprises a skin preparation agent. In embodiments, the skin preparation agent is povidone iodine. In embodiments, the kit further comprises a geographical locating device. In embodiments, the geographical locating device is a GPS transponder chip. In embodiments, the kit further comprises an environmental monitoring device with or without remote and distant data transmission and storage capabilities. In embodiments, the environmental monitoring device with or without remote and distant data transmission and storage capabilities is at least one of an analog or digital temperature monitor, a pressure sensor, an accelerometer, a particle counter, and an air composition monitor. In embodiments, the kit further comprises antimicrobial monitoring. In embodiments, the kit further comprises a security feature. In embodiments, the security feature is at least one of a physical lock, a digital code entry screen, a key card access point, a biometric scanner, biometric data storage and tracing, a tamper indicator, and a leak detector. In embodiments, the kit further comprises a mechanism to be connected to transportation vehicles. In embodiments, the mechanism to be connected to transportation vehicles is at least one of a physical mechanism to be carried by an unmanned aerial vehicle, a mechanism to attach to other similar kits for grouped transport and movement, a mechanism for a group of connected kits to be carried by an unmanned aerial vehicle, a mechanism to attach to the internal or external surface of motorized or non-motorized transportation devices, a robotic self-driving chassis, a mechanism to attach to the internal or external surface of a self-driving vehicle, and a mechanism to attach to the internal or external surface of an object intended to travel beyond Earth's atmosphere.

[0152] Also disclosed herein is a method of using a kit to harvest a skin tissue sample from a subject, comprising (i) cleaning the skin; (ii) injecting an effective amount of the local anesthetic to produce a insensate skin area; (iii) biopsying the skin at a target site within the insensate skin area using the biopsy device; (iv) excising the biopsy to provide a tissue sample and a tissue cavity; (v) placing the tissue sample in a specimen container; (vi) closing the tissue cavity with suture to provide a biopsy site; and (vii) dressing the biopsy site with appropriate dressings, wherein the kit comprises: (i) an insulated mailer; (ii) a temperature tracker, (iii) a cooling component, (iv) a biohazard bag, (v) a local anesthetic, (vi) a vasoconstrictor, (vii) an absorbent pack, (viii) sterile gloves, (ix) forceps, (x) scissors, (xi) a needle driver, (xii) an antimicrobial agent, (xiii) a biopsy device, and (xiv) a skin marking device.

[0153] In embodiments, the method further comprises placing the tissue sample in a biohazard bag. In embodiments, the biohazard bag further comprises a cooling component. In embodiments, the biopsy device is at least one of a scalpel, a needle biopsy device, a hookwire biopsy device, a photonic needle, a clamp, forceps, micro-scissors, a punch biopsy device, a core biopsy device, a razor, a shave biopsy device, and a cutaneous needle biopsy device. In embodiments, the tissue sample is a full-thickness sample of skin.

[0154] Further disclosed herein is a method of using a kit to preserve and transport a tissue sample to a second location comprising adding the tissue sample to a specimen container; enclosing the specimen container within a first biohazard bag: enclosing the first biohazard bag containing the specimen container within a second biohazard bag containing the absorbent pad; enclosing the first and second biohazard bags within an insulated mailer, wherein the insulated mailer comprises a cooling component and a temperature tracker; and transporting the insulated mailer to the second location, wherein the kit comprises: (i) an insulated mailer; (ii) a temperature tracker, (iii) a cooling component, (iv) a biohazard bag, (v) a local anesthetic, (vi) a vasoconstrictor, (vii) an absorbent pack, (viii) sterile gloves, (ix) forceps, (x) scissors, (xi) a needle driver, (xii) an antimicrobial agent, (xiii) a biopsy device, and (xiv) a skin marking device.

[0155] In embodiments, the tissue sample arrives at the second location in less than 24 hours after the biopsy. In embodiments, the tissue sample is maintained at about 4 C. during transport.

[0156] In embodiments, the viability of the tissue sample is maintained during transport.

[0157] Disclosed herein is a kit for use in harvesting and deploying a tissue sample comprising: (i) an insulated mailer; (ii) a temperature tracker, (iii) a cooling component, (iv) a biohazard bag, (v) a local anesthetic, (vi) a vasoconstrictor, (vii) an absorbent pack, (viii) sterile gloves, (ix) forceps, (x) scissors, (xi) a needle driver, (xii) an antimicrobial agent, (xiii) a biopsy device, and (xiv) a skin marking device.

[0158] In embodiments, the cooling component is at least one of a freezer pack, dry ice, wet ice, and liquid nitrogen. In embodiments, the biopsy device is at least one of a scalpel, a needle biopsy device, a hookwire biopsy device, a photonic needle, a clamp, forceps, micro-scissors, a punch biopsy device, a core biopsy device, a razor, a shave biopsy device, and a cutaneous needle biopsy device. In embodiments, the skin marking device is at least one of a surgical marker, a colorant dispensing syringe, and a temporary skin pattern impressing device. In embodiments, kit includes at least one of an irrigation syringe, a wound dressing, and a skin preparation agent. In embodiments, the local anesthetic is lidocaine, the vasoconstrictor is epinephrine, and the antimicrobial agent is povidone iodine.

[0159] Disclosed herein is a method of harvesting a skin tissue sample, comprising providing a kit having an insulated mailer; a temperature tracker; a cooling component; a biohazard bag; a biopsy device; a local anesthetic; and at least one of a vasoconstrictor, an absorbent pack, sterile gloves, a needle driver, an antimicrobial agent, and a skin marking device; cleaning the skin; injecting an effective amount of the local anesthetic to produce a insensate skin area; biopsying the skin at a target site within the insensate skin area using the biopsy device; excising the biopsy to provide a tissue sample; and placing the tissue sample in the insulated mailer.

[0160] In embodiments, the cooling component is at least one of a freezer pack, dry ice, wet ice, and liquid nitrogen. In embodiments, the biopsy device is at least one of a scalpel, a needle biopsy device, a hookwire biopsy device, a photonic needle, a clamp, forceps, micro-scissors, a punch biopsy device, a core biopsy device, a razor, a shave biopsy device, and a cutaneous needle biopsy device. In embodiments, the skin marking device is at least one of a surgical marker, a colorant dispensing syringe, and a temporary skin pattern impressing device. In embodiments, kit includes at least one of an irrigation syringe, a wound dressing, and a skin preparation agent. In embodiments, the local anesthetic is lidocaine, the vasoconstrictor is epinephrine, and the skin preparation agent is povidone iodine.

[0161] Disclosed herein is a method of using a tissue sample comprising providing a kit having an insulated mailer that includes a temperature tracker; a cooling component; a specimen container; a biohazard bag; a biopsy device; a local anesthetic; and at least one of a vasoconstrictor, an absorbent pack, sterile gloves, a needle driver, an antimicrobial agent, and a skin marking device; placing a tissue sample in a specimen container; enclosing the specimen container and the absorbent pack within a biohazard bag; placing the biohazard bag within the insulated mailer; and transporting the insulated mailer to a second location.

[0162] In embodiments, the cooling component is at least one of a freezer pack, dry ice, wet ice, and liquid nitrogen. In embodiments, the biopsy device is at least one of a scalpel, a needle biopsy device, a hookwire biopsy device, a photonic needle, a clamp, forceps, micro-scissors, a punch biopsy device, a core biopsy device, a razor, a shave biopsy device, and a cutaneous needle biopsy device. In embodiments, the skin marking device is at least one of a surgical marker, a colorant dispensing syringe, and a temporary skin pattern impressing device. In embodiments, the kit includes at least one of an irrigation syringe, a wound dressing, and a skin preparation agent. In embodiments, the local anesthetic is lidocaine, the vasoconstrictor is epinephrine, and the antimicrobial agent is povidone iodine. In embodiments, the tissue sample arrives at the second location in less than 72 hours after the tissue sample is placed in the specimen container. In embodiments, the tissue sample is maintained at a temperature in the range of 0 C. to 10 C. during said transporting.

EXAMPLES

Example 1: Use of the Harvesting Kit

[0163] 1. Prepare a full-thickness skin excisional biopsy site in a manner that is consistent with current clinical standard of care utilizing the materials provided in harvest kit and in particular, as described in Example 2. [0164] 2. Once harvested, place the excisional skin biopsy in the sterile container and add transport solution. [0165] 3. Close the sterile container tightly and add to the biohazard bag. [0166] 4. Place a label on the biohazard bag in order to correlate with the patient identification number (PIN). [0167] 5. Place the labeled biohazard bag containing the tissue specimen into a second biohazard bag containing an absorbent pad. [0168] 6. Place the packaged specimen into the included NanoCool insulated container and activate the NanoCool cooling system by pressing the button on the underside of the NanoCool lid. The package should become cool within 1 minute. [0169] 7. Activate the temperature tracker strip stuck to the bottom of the NanoCool lid. [0170] 8. Close the NanoCool box and ensure that there is a pre-filled shipping label already in place. [0171] 9. Secure the lid of the box with a tamperproof sealing label and contact the FedEx carrier number on shipping label for same day pick up.

Example 2: Harvesting the Tissue Sample

[0172] Prepare the biopsy site using surgical betadine prep and drape in standard fashion to ensure sterility. [0173] Inject local anesthetic in standard clinical fashion. [0174] Sharply excise a full-thickness specimen including epidermis to fat and do not defat the specimen.