An external medical device includes a fluid inlet, an inlet valve in fluid communication with the fluid inlet to control fluid flow through the fluid inlet in response to fluid inlet control signals, a fluid outlet in fluid communication with a fluid reservoir, a fluid pump configured to deliver a therapeutic fluid from the fluid reservoir through the fluid outlet in response to fluid outlet control signals, a fluid sensor configured to monitor the therapeutic fluid between the fluid pump and the fluid outlet and further configured to output sensor data corresponding to a monitored condition of the therapeutic fluid, and a control module configured to receive the sensor data and output, based on the sensor data, the fluid inlet control signals to the inlet valve and the fluid outlet control signals to the fluid pump.

The invention relates to an artificial womb system for supporting newborns, in particular extremely premature infants between the 21/0 and 28/0 week of pregnancy, comprising the following: a chamber (1) of the artificial womb, said chamber being formed by an at least partially ultrasound-permeable wall (2) and comprising a lumen (14) for maintaining a physiologically intraamnial pressure and for receiving the artificial amniotic fluid (15) and a newborn or a premature infant, at least one access for supplying the premature infant in the artificial womb with nutrients, a dialysis device (9), and an oxygenator (8) and/or a gassing device for supplying oxygen to the newborn or premature infant, wherein means are provided in order to maintain an intraamnial pressure of >0 mBar in the chamber (1) of the artificial womb, said pressure acting on the newborn, in addition to the atmospheric pressure.

Provided herein is a pre-Caesarean method for collecting amniotic fluid from a patient. A needle is inserted into the incision site for the future C-section, which may be under ultrasound guidance, through which the amniotic fluid is drawn under a low level suction and, optionally, gravity to a sterile collection container. The method encompasses filtering and/or irradiating the amniotic fluid to collect biomolecules of interest such as growth factors and/or stem cells. Also provided is the sterile amniotic fluid or filtrates thereof collected by the method described herein

Provided herein is a pre-Caesarean method for collecting amniotic fluid from a patient. A needle is inserted into the incision site for the future C-section, which may be under ultrasound guidance, through which the amniotic fluid is drawn under a low level suction and, optionally, gravity to a sterile collection container. The method encompasses filtering and/or irradiating the amniotic fluid to collect biomolecules of interest such as growth factors and/or stem cells. Also provided is the sterile amniotic fluid or filtrates thereof collected by the method described herein.

Provided herein is a method for sterilely filtering amniotic fluid from selected caesarean sections of an individual. The amniotic fluid is first centrifuged at 5,000 to 10,000 rpm for 30 to 60 minutes and filtered through filters with about 5 to about 10 m pore size. Next, the fluid is sequentially filtered through a series of membrane filters with the pore sizes 1 m and 0.45 or/and 0.2 m. The filtrate is then aseptically transferred to and sealed in syringes or vials. The fluid is subsequently lyophilized to obtain the lyophilisate of amniotic fluid. Amniotic fluid is reconstituted by adding sterile water to the lyophilisate, and the reconstituted fluid is used for wound healing, cosmetic, orthopedic or ophthalmic applications, particularly for the treatment of dry eyes.

A frozen therapeutic dose includes an amniotic material and is configured into a pack for easy administering of the dose to a treatment location. A frozen therapeutic dose may contain a concentration of live amniotic stem cells. A frozen therapeutic dose may be provided in a form, such as a multi-pack form, to enable a person to administer a dose to a treatment location without the need of traveling to a doctor's office or clinic. A frozen therapeutic dose package may be kept in a conventional freezer at 20 C., for example, for extended periods of time and a person may remove the package as needed for treatment. A frozen dose package or pack may contain a secondary material configured to mix with the frozen therapeutic dose. A secondary material may be configured within a single dose compartment with the frozen dose or within a separate compartment.

A system for aseptic collection of mammalian amniotic fluid. The system includes a cannula having an attachment end and external end. The attachment end provides a concentric opening to a hollow chamber disposed about a central passage. The hollow chamber has a port disposed adjacent to the external end permitting at least a partial suction to be established within the hollow chamber, the attachment end thereby suctionally attached to a surface when the attachment end is disposed upon the surface. The central passage provides access to a central portion of the surface surrounded by the concentric opening of the hollow chamber. An extraction needle is disposed within the central passage of the cannula and presented to the central portion of the surface. The extraction needle penetrates the central portion of the surface and extracts amniotic fluid there beneath. An associated method of use is also provided.

A frozen therapeutic dose includes an amniotic material and is configured into a pack for easy administering of the dose to a treatment location. A frozen therapeutic dose may contain a concentration of live amniotic stem cells. A frozen therapeutic dose may be provided in a form, such as a multi-pack form, to enable a person to administer a dose to a treatment location without the need of traveling to a doctor's office or clinic. A frozen therapeutic dose package may be kept in a conventional freezer at 20 C. for example, for extended periods of time and a person may remove the package as needed for treatment. A frozen dose package or pack may contain a secondary material configured to mix with the frozen therapeutic dose. A secondary material may be configured within a single dose compartment with the frozen dose or within a separate compartment.

Disclosed are a method of wound healing and an apparatus for the collection, processing and application of amniotic fluid at a wound site to improve healing. The apparatus includes a canister or bag positioned along the vacuum line through which the amniotic fluid and placental aspirate is suctioned. The canister or bag also has a sterile syringe port, through which amniotic fluid can be extracted and later processed. The processed material can then be applied to the wound site of the patient. The apparatus and method disclosed allow for the processing of the amniotic fluid to take place in the same room as the surgical procedure. A kit is provided but not limited to including an amnion rupture tool, a canister or bag for collection, Yankauer suction tip, tubing, and a dual syringe mixing sprayer for reapplication.

Described is a skin regeneration therapy. The described therapy combines precise bioelectric signals, light, and biologics for skin treatment and regeneration. Precise bioelectric signals give clear instructions to the stimulated cell DNA/RNA to produce specific regenerative proteins on demand. Bioelectric signals give clear instructions to cell membranes on what to let in and what to let out and serve as an equivalent or surrogate of environmental stimuli to cause a cell action in response.