APPARATUS AND METHODS FOR DELIVERING FLUID AND MATERIAL TO A SUBJECT

• US 20070233038A1
• Filed: 02/08/2007
• Published: 10/04/2007
• Est. Priority Date: 02/09/2006
• Status: Active Grant

• Current Assignee: Aderans Research Institute Incorporated
• Original Assignee: Aderans Research Institute Incorporated
• Inventors: Rathgeber, Martin, DePiano, John, Cochran, Stephen, Stenn, Kurt, Prokop, Gary, Marshall, Bryan, Pruitt, Terrell, Washenik, Kenneth, Su, Yandong
• Granted Patent: US 7,780,635 B2
• Time in Patent Office: Days
• US Class Current: 604/522
• CPC Class Codes: A61M 2005/2411 from the front
• CPC Class Codes: A61M 2005/2414 from the side
• CPC Class Codes: A61M 2005/341 angularly adjustable or angled away from the axis of the injector
• CPC Class Codes: A61M 2005/342 Off-center needles, i.e. needle connections not being coaxial with the longitudinal symmetry axis of syringe barrel
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 5/3148 Means for causing or aiding aspiration or plunger retraction
• CPC Class Codes: A61M 5/31551 including axial movement of dose setting member
• CPC Class Codes: A61M 5/31573 Accuracy improving means
• CPC Class Codes: A61M 5/31586 performed by rotationally moving or pivoted actuator, e.g. an injection lever or handle

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.

Claims

1. A fluid delivery device comprising:

a housing body having an exterior and an interior and a syringe cartridge aperture;

a pinion housing attached to the interior of the housing body, the pinion housing having a pinion receiving aperture;

a pinion which is received by the pinion receiving aperture, and attached to the pinion housing such that it can rotate within the pinion receiving aperture, the pinion comprising a front section having gear ridges, a syringe receiving aperture, and a rear section;

a detachable syringe cartridge having a head portion, a syringe body, a main portion, a plunger and a needle;

the head portion engages the housing body and is attached to the syringe body;

the syringe body has an interior channel;

the main body has an interior channel, the main body being attached to the syringe body and the interior channel of the main body having a threaded portion;

the plunger is received by the interior channels of the syringe body and the main body, the plunger having a plunger tip, a threaded screw section which engages with the threaded portion of the interior channel of the main body, and a tail section which is received by the syringe receiving aperture of the pinion and which engages with the rear section of the pinion;

the needle is attached to the head portion of the syringe cartridge and is operatively connected to the interior channel of the syringe body; and

a trigger portion having a tab section which is adapted to engage with the gear ridges of the pinion when depressed, the trigger portion being attached at one end to the pinion housing.

2. The fluid delivery device of claim 1 wherein the housing body comprises a rear portion and a front portion.

3. The fluid delivery device of claim 2 wherein the pinion housing further comprises an exterior threaded portion and the rear and front portion of the housing body contain threaded portions in the interior of the housing bodies, wherein the threaded portions of the front and rear housing bodies engage the threaded portion of the pinion housing.

4. The fluid delivery device of claim 1 wherein the head portion of the syringe cartridge is made from a clear material.

5. The fluid delivery device of claim 1 wherein the tail section of the plunger is splined and the rear section of the pinion contains channels designed to receive the splines of the tail section of the plunger.

6. The fluid delivery device of claim 1 wherein the housing body has a longitudinal axis and wherein the needle is at an acute angle to the longitudinal axis of the housing body.

7. The fluid delivery device of claim 6 wherein the needle is at an approximately 40°

angle to the longitudinal axis of the housing body.

27. The method of claim 26, wherein the cellular material is injected with the device of claims 1 or 8.

45. A method of delivering a material into a subject'"'"'s skin using the fluid delivery device of claim 1 comprising the steps of:

i) loading the syringe cartridge into the housing body of the fluid delivery device, wherein the syringe body is filled with the material;

ii) inserting the needle of the 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 depressing the trigger portion of the fluid delivery device;

iv) rotating the fluid delivery device approximately 45 to 90 degrees; and

v) removing the needle from the injection site.

46. The method of claim 45, wherein the desired depth is four to six millimeters below the skin surface.

47. The method of claim 45, wherein the material is selected from the group consisting of botox, collagen, hyaluronic acid, antibiotics, anti-inflammatory drugs, steroids and combinations thereof.

48. The method of claim 45, wherein the material is a cellular material comprising cells.

49. The method of claim 48, wherein the 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.

50. The method of claim 48, wherein the cells retain their inherent morphologic characteristics upon injection.

8. A micrometer assisted fluid delivery device comprising:

a holder portion comprising a main body having a front section and a back section;

a micrometer having a main body, an adjustment thimble and a spindle, wherein the main body of the micrometer is attached to the back section of the main body of the holder portion;

a syringe comprising a main body and a plunger, the main body of the syringe having an inner channel which receives the plunger;

wherein the main body of the syringe is attached to the front section of the main body of the holder portion and the plunger is attached to the spindle of the micrometer.

9. The micrometer assisted fluid delivery device of claim 8 wherein the micrometer main body is attached to the back section of the main body within a micrometer receiving aperture located in the back section of the main body of the holder portion.

10. The micrometer assisted fluid delivery device of claim 8 wherein the main body of the syringe is attached to the front section of the main body within a syringe body receiving aperture located in the front section of the main body of the holder portion.

39. A method of delivering a material into a subject'"'"'s skin using the micrometer assisted fluid delivery device of claim 8 comprising the steps of:

i) aspirating a material into the micrometer assisted fluid delivery device 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.

40. The method of claim 39, wherein the desired depth is four to six millimeters below the skin surface.

41. The method of claim 39, wherein the material is selected from the group consisting of botox, collagen, hyaluronic acid, antibiotics, anti-inflammatory drugs, steroids and combinations thereof.

42. The method of claim 39, wherein the material comprises cells.

43. The method of claim 42, wherein the 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.

44. The method of claim 42, wherein the cells retain their inherent morphologic characteristics upon injection.

11. A micrometer assisted fluid delivery device comprising:

a holder portion comprising a main body having a front section, an intermediate section, and a back section;

the main body having a top, a bottom and two side walls;

the front section having a front face, a back face, side walls that extend from the side walls of the main body, and a syringe body receiving channel;

the intermediate section having a front face, a back face, side walls that extend from the side walls of the main body and a syringe plunger receiving channel;

the back section having a front face, a back face, side walls that extend from the side walls of the main body and a micrometer receiving aperture that passes from the front face to the back face of the back section;

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 back section of the holder portion;

a syringe comprising a main body, finger tabs, a plunger and a plunger tabbed end;

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 receiving channel;

the plunger is received by the syringe plunger receiving channel;

the finger tabs are positioned between the intermediate and the front section of the main body of the holder portion; and

the spindle of the micrometer is in contact with the plunger head of the syringe.

12. The micrometer assisted fluid delivery device of claim 11 wherein the spindle is attached to the plunger tabbed end.

13. The micrometer assisted fluid delivery device of claim 11 wherein the back section of the main body of the holder portion further comprises a micrometer securing threaded aperture which receives a screw which can be tightened to secure the main body of the micrometer to the back section of the main body of the holder portion.

14. The micrometer assisted fluid delivery device of claim 11 wherein the front face of the front section of the main body of the holder portion has a threaded channel that receives a screw which can be tightened to secure the finger tab of the syringe to the intermediate section of the main body of the holder portion.

15. A micrometer assisted fluid delivery device comprising:

a holder portion comprising a main body having a front face, a back face, a top, a bottom, two side walls, an interior channel, a syringe finger tab channel, a syringe body channel, a syringe plunger channel and a micrometer receiving aperture which passes through the back face of the main body to the interior channel of the main body;

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 comprising a main body, finger tabs, a plunger and a plunger tabbed end;

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 receiving channel of the holder portion;

the plunger is received by the syringe plunger channel of the holder portion;

the finger tabs are received by the syringe finger tab channel; and

the spindle of the micrometer is in contact with the plunger head of the syringe.

16. The micrometer assisted fluid delivery device of claim 15 comprising a syringe plunger holder comprising a main body having a front face, a back face, a side wall, a syringe tabbed end channel which receives the syringe plunger tabbed end, and a syringe plunger channel which receives the syringe plunger, and a spindle channel which receives the spindle of the micrometer.

17. The micrometer assisted fluid delivery device of claim 16 wherein the main body of the syringe plunger holder further comprises a spindle securing threaded aperture that receives a screw which can be tightened to secure the spindle of the micrometer.

18. The micrometer assisted fluid delivery device of claim 15 wherein the main body of the holder portion further comprises a micrometer securing threaded aperture which receives a screw which can be tightened to secure the main body of the micrometer to the main body of the holder portion.

19. The micrometer assisted fluid delivery device of claim 15 wherein the front face of the main body of the holder portion has a threaded channel that receives a screw which can be tightened to secure the finger tab of the syringe to the main body of the holder portion.

20. A micrometer assisted fluid delivery device 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;

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.

21. The micrometer assisted fluid delivery device of claim 20 wherein the plunger of the syringe is received by a syringe plunger channel located on the bottom of the syringe plunger yoke.

22. The micrometer assisted fluid delivery device of claim 21 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.

23. The micrometer assisted fluid delivery device of claim 20 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.

24. The micrometer assisted fluid delivery device of claim 20 wherein the syringe further comprises finger tabs which are received by a syringe tab channel in the main body of the holder portion.

25. The micrometer assisted fluid delivery device of claim 24 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.

26. A method of delivering cellular material comprising injecting the cellular material to a subject, wherein the cellular material comprises cells that retain their inherent morphologic characteristics upon injection.

28. The method of claim 26, wherein the 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.

29. The method of claim 26, wherein the cellular material further comprises a suspension media.

30. The method of claim 26, wherein the cellular material is delivered to a subject in an amount effective to treat a disease or a physical condition which afflicts the subject.

31. The method of claim 30, wherein the disease or condition is hair loss.

32. The method of claim 30, 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.

33. The method of claim 26, wherein the cells comprise follicular progenitor cells.

34. The method of claim 33, wherein the follicular progenitor cells are autologous.

35. The method of claim 34, wherein the cells comprise dermal cells.

36. The method of claim 34, wherein the cells comprise epidermal cells.

37. The method of claim 26 wherein the cells are delivered to the skin of the subject.

38. The method of claim 36, wherein the cells are delivered to the skin'"'"'s subepidermal layer, papillary dermal layer or upper reticular dermal layer.

51. A cellular material delivery device comprising an elongated shaft having a diameter, a latitudinal axis, a circumference and proximal, medial and distal portions, the distal portion having a sharpened point and the medial portion having series of annular grooves that run around the circumference of the shaft.

52. The cellular material delivery device of claim 51, wherein the sharpened point is a pencil shaped point.

53. The cellular material delivery device of claim 51, wherein the sharpened point is a trocar shape having three facetted sections.

54. The cellular material delivery device of claim 53, wherein the elongated shaft further comprises an axial channel that runs along a portion of the shaft and onto one of the facetted sections.

55. The cellular material delivery device of claim 51, wherein the annular grooves are helically orientated around the medial portion of the shaft.

56. The cellular material delivery device of claim 51, wherein the diameter of the shaft is less than 1 millimeter.

57. The cellular material delivery device of claim 51, wherein the annular grooves have a depth of less than 0.5 millimeters.

58. The cellular material delivery device of claim 57, wherein the annular grooves have a depth of approximately 0.15 millimeters.

59. The cellular material delivery device of claim 51, wherein the annular grooves have a width of 0.5 millimeters or less.

60. The cellular material delivery device of claim 59, wherein the annular grooves have a width of approximately 0.2 millimeters.

61. A method of using the cellular delivery device of claim 51 to deposit cellular material under the surface of skin comprising the steps of:

i) depositing the material on the surface;

ii) piercing the surface using the sharpened point of the cellular delivery device;

iii) continuing insertion of the cellular delivery device into the surface, the annular grooves picking up the material from the surface and conveying the material beneath the surface; and

iv) withdrawing the apparatus from the surface having deposited the material below the surface.