Claims for Patent: 8,206,335

Summary for Patent: 8,206,335

Title:	Apparatus and methods for delivering fluid and material to a subject
Abstract:	The present invention provides fluid and material delivery methods and devices for practicing the methods. The invention provides a method of delivering cellular material comprising injecting the cellular material into a subject such that the injected cells retain their inherent morphologic characteristics upon injection. The method comprises the steps of aspirating the cellular material into a fluid delivery device which incorporates a syringe arrangement. The cellular material is aspirated into the main body of the syringe until the desired amount of a material has filled the syringe body. The needle of the fluid delivery device is then inserted into the skin of a subject at an angle about parallel to the skin until a desired depth has been reached. The cellular material is then injected in the subject until the desired volume of material has been injected. The needle of the device is then rotated approximately 45 to 90 degrees and the needle is removed from the injection site.
Inventor(s):	Pruitt; Terrell (Lawrenceville, GA), Cochran; Stephen A. (Tucker, GA), Marshall; Bryan (Atlanta, GA), Su; Yandong (Atlanta, GA)
Assignee:	Aderans Research Institute, Inc. (Marietta, GA)
Application Number:	12/836,336
Patent Claims:	1. A micrometer assisted fluid delivery device, having a configuration suitable for single hand operational control by a user comprising: a holder portion comprising a main body having a front face, a back face, a top, a bottom, side walls, a syringe body channel, a plunger yoke channel, and a micrometer receiving aperture located on the front face and passing through to the plunger yoke channel, wherein the syringe body channel is located on the front face and passes through to the plunger yoke channel; a micrometer having a main body, an adjustment thimble and a spindle, wherein the main body of the micrometer is received by the micrometer receiving aperture of the holder portion; a syringe plunger yoke comprising a main body having a front face, a back face, a top, a bottom and side walls; a syringe comprising a main body and a plunger; the main body of the syringe having an inner channel which receives the plunger and the main body of the syringe is received by the syringe body channel of the holder portion; the plunger is attached to the syringe plunger yoke; and wherein the spindle of the micrometer is attached to the syringe plunger yoke, wherein in use the adjustment thimble of the micrometer is manually turned by the user to administer a volume of a fluid from the syringe, and wherein the plunger of the syringe moves forward or backward depending on the direction in which the user turns the adjustment thimble. 2. The micrometer assisted fluid delivery device of claim 1 wherein the plunger of the syringe is received by a syringe plunger channel located on the bottom of the syringe plunger yoke. 3. The micrometer assisted fluid delivery device of claim 2 wherein the syringe further comprises a plunger tabbed end which is received by a syringe plunger tabbed end channel located on the bottom of the syringe plunger yoke. 4. The micrometer assisted fluid delivery device of claim 1 wherein the spindle of the micrometer is attached to the syringe plunger yoke within a spindle receiving aperture, the spindle being friction fit within the spindle receiving aperture. 5. The micrometer assisted fluid delivery device of claim 1 wherein the syringe further comprises finger tabs which are received by a syringe tab channel in the main body of the holder portion. 6. The micrometer assisted fluid delivery device of claim 5 wherein the device further comprises a syringe holder block received by the syringe tab channel, the syringe block holder having a syringe plunger channel that receives the syringe plunger, the syringe plunger block securing the finger tabs of the syringe to the main body of the holder portion by pressure exerted on the syringe plunger block by a spring located in a spring channel located in the main body of the holder portion, the spring channel extending from the back face of the main body of the holder portion to the syringe tab channel. 7. A method of delivering material comprising injecting the material to a subject with the device of claim 1, wherein the material is a cellular material comprising cells that retain their inherent morphologic characteristics upon injection, or a liquid material selected from the group consisting of botox, collagen, hyaluronic acid, antibiotics, anti-inflammatory drugs, steroids and combinations thereof. 8. The method of claim 7, wherein the material is a cellular material comprising cells are selected from the group consisting of dermal cells, epidermal cells, epidermal stem cells, basal cells, keratinocytes, melanocytes, trichogenic dermal cells, fibroblasts, follicular progenitor cells, pancreatic islet cells, adipose cells, dental epithelial cells, dental dermal cells and combinations thereof. 9. The method of claim 7, wherein the cellular material further comprises a suspension media. 10. The method of claim 7, wherein the material is delivered to a subject in an amount effective to treat a disease or a physical condition which afflicts the subject. 11. The method of claim 10, wherein the disease or condition is hair loss. 12. The method of claim 10, wherein the disease or physical condition is selected from the group consisting of hair loss, psoriasis, diabetes, rhytids, skin atrophy, tooth loss, skin ulcers, bed sores, diabetic foot ulcers, burn wounds, microbial infections, surgical scars, acne, chicken pox and combinations thereof. 13. The method of claim 7, wherein the material is a cellular material comprising cells comprise follicular progenitor cells. 14. The method of claim 13, wherein the follicular progenitor cells are autologous. 15. The method of claim 14, wherein the material is a cellular material comprising dermal cells. 16. The method of claim 14, wherein the material is a cellular material comprising epidermal cells. 17. The method of claim 7 wherein material is a cellular material and wherein the cells are delivered to the skin of the subject. 18. The method of claim 16, wherein the cells are delivered to the skin's subepidermal layer, papillary dermal layer or upper reticular dermal layer. 19. The method of claim 7 for delivering a material into a subject's skin comprising the steps of: i) aspirating a material into the micrometer assisted fluid delivery device of claim 1 by turning the micrometer adjustment thimble until the desired amount of the material has filled the syringe body of the micrometer assisted fluid delivery device; ii) inserting the needle of the micrometer assisted fluid delivery device into the skin at an angle about parallel to skin until a desired depth has been reached; iii) injecting the material by turning the micrometer adjustment thimble in increments until the desired volume has been injected; iv) rotating the micrometer assisted fluid delivery device approximately 45 to 90 degrees; and v) removing the needle from the injection site. 20. The method of claim 19, wherein the desired depth is four to six millimeters below the skin surface. 21. The micrometer assisted fluid delivery device of claim 1, wherein the axis of the syringe lies in a plane that is parallel to but does not align with a second plane in which the axis of the spindle lies. 22. The micrometer assisted fluid delivery device of claim 1, wherein the holder portion further comprises a protruding section to stabilize the main body of the syringe, wherein the protruding section is located in the bottom portion of the front face. 23. The method of claim 19, wherein each 0.001 inch increment on the micrometer adjustment thimble is designed to deliver 0.25 .mu.l of the material.

Details for Patent 8,206,335

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Allergan, Inc.	BOTOX COSMETIC	onabotulinumtoxina	For Injection	103000	12/09/1991		2026-02-09
Allergan, Inc.	BOTOX	onabotulinumtoxina	For Injection	103000	12/09/1991		2026-02-09