Claims for Patent: 6,569,143

Summary for Patent: 6,569,143

Title:	Method of intradermally injecting substances
Abstract:	A method of making an intradermal injection using a drug delivery device containing the substance to be injected. A device for practicing the method includes a needle cannula having a forward tip and a limiter portion having a skin engaging surface surrounding the needle cannula. The needle cannula is in fluid communication with the substance and the tip of the needle cannula extends beyond the skin engaging surface a distance equal to approximately 0.5 mm to 3.0 mm. The needle cannula includes a fixed angle of orientation relative to the plane of the skin engaging surface. The skin engaging surface limits penetration of the needle tip into the skin so that the substance can be expelled through the needle tip into the dermis layer. Preferably, the fixed angle of orientation of the needle cannula is generally perpendicular relative to the skin surface, and the skin engaging surface is generally flat.
Inventor(s):	Alchas; Paul G. (Wayne, NJ), Laurent; Philippe Emile Fernand (Oullins, FR)
Assignee:	Becton, Dickinson and Company (Franklin Lakes, NJ)
Application Number:	09/835,243
Patent Claims:	1. A method of making an intradermal injection into the skin of an animal comprising the steps of: providing a drug delivery device including a needle cannula having a forward needle tip and said needle cannula being in fluid communication with a substance contained in said drug delivery device and including a limiter portion surrounding said needle cannula and said limiter portion including a skin engaging surface, with said needle tip of said needle cannula extending from said limiter portion beyond said skin engaging surface a distance equal to approximately 0.5 mm to approximately 3.0 mm and said needle cannula having a fixed angle of orientation relative to a plane of the skin engaging surface of the limiter portion; inserting said needle tip into the skin of an animal and engaging the surface of the skin with said skin engaging surface of said limiter portion such that the skin engaging surface of the limiter portion limits penetration of the needle tip into the dermis layer of the skin of the animal; and expelling the substance from said drug delivery device through the needle tip into the skin of the animal. 2. A method as set forth in claim 1 wherein said substance is selected from the group consisting of drugs, vaccines and the like used in the prevention, diagnosis, alleviation, treatment, or cure of diseases. 3. A method as set forth in claim 1 wherein said fixed angle of orientation of said needle cannula is further defined as being generally perpendicular to said plane of said skin engaging surface of the limiter portion within about fifteen degrees. 4. A method as set forth in claim 3 wherein said fixed angle of orientation of said needle cannula is further defined as being ninety degrees relative to said plane of the skin engaging surface of the limiter portion within about five degrees. 5. A method as set forth in claim 1 wherein said drug delivery device comprises a syringe having a barrel and a plunger received within said barrel therein and plunger being depressable to expel said substance from said delivery device through the tip of said needle cannula. 6. A method as set forth in claim 5 wherein said barrel includes a barrel tip and said needle cannula forms part of a needle assembly attachable to and in fluid communication with said barrel tip. 7. A method as set forth in claim 1 further including the step of selecting an injection sight on the skin of the animal. 8. A method as set forth in claim 7 further including the step of cleaning the injection sight on the skin of the animal prior to expelling the substance from the drug delivery device into the skin of the animal. 9. A method as set forth in claim 1 further comprising the step of filling the drug delivery device with the substance. 10. A method as set forth in claim 1 further including the step of pressing said skin engaging surface of said limiter portion against the skin of the animal and applying pressure thereby stretching the skin of the animal. 11. A method as set forth in claim 1 further including the step of withdrawing the needle cannula from the skin after injecting the substance. 12. A method as set forth in claim 1 wherein said step of inserting said forward tip into the skin is further defined by inserting said forward tip into the skin to a depth of from approximately 1.0 mm to approximately 2.0 mm. 13. A method as set forth in claim 1 wherein said step of inserting said forward tip into the skin is further defined by inserting said forward tip into the skin to a depth of 1.5 mm.+-.0.2 mm to 0.3 mm. 14. A method as set forth in claim 1 wherein said substance comprises an influenza vaccine. 15. A method as set forth in claim 1 wherein said substance comprises a hepatitis B vaccine. 16. A method as set forth in claim 1 wherein said substance comprises a rabies vaccine. 17. A method as set forth in claim 1 wherein said substance comprises a cancer vaccine. 18. A method as set forth in claim 1 wherein said substance comprises a genetic based vaccine. 19. A method as set forth in claim 1 wherein said substance comprises a tuberculin test substance. 20. A method of making an intradermal injection with a drug delivery device having a limiter with a skin engaging surface limiting the depth a needle cannula can be inserted into the skin of an animal comprising the steps of: exposing a forward tip of said needle cannula extending from a limiter beyond a skin engaging surface a distance equal to approximately 0.5 mm to approximately 3.0 mm and said needle cannula having a fixed angle of orientation relative to the skin engaging surface of the limiter; inserting said forward tip of the needle cannula into the skin of the animal at until said skin engaging surface contacts the skin of the animal; and expelling a substance from said device into the dermis layer of the skin of the animal. 21. A method as set forth in claim 20 wherein said step of inserting said forward tip into the skin of the animal is further defined by inserting said forward tip into the skin at an angle being generally perpendicular to the skin. 22. A method as set forth in claim 20 wherein said step of inserting said forward tip into the skin of the animal is further defined by inserting said forward tip into the skin at an angle of generally ninety degrees to the skin. 23. A method as set forth in claim 20 wherein said fixed angle of orientation relative to said skin engaging surface is further defined as being generally perpendicular within about fifteen degrees. 24. A method as set forth in claim 23 wherein said drug delivery device comprises a syringe having a barrel and a plunger received within said barrel and said plunger being depressable to expel said substance from said delivery device through the forward tip of said needle cannula. 25. A method as set forth in claim 24 wherein said step of expelling the substance from said delivery device is further defined by grasping said hypodermic needle with a first hand and depressing said plunger with an index finger of a second hand. 26. A method as set forth in claim 24 wherein said step of expelling the substance from said delivery device is further defined by grasping said hypodermic needle with a first hand and depressing said plunger on said hypodermic needle with a thumb of a second hand. 27. A method as set forth in claim 24 wherein said step of inserting the said forward tip into the skin of the animal is further defined by pressing the skin of the animal with said limiter. 28. A method as set forth in claim 24 further including the step of attaching a needle assembly to a tip of said barrel of said syringe with said needle assembly including said needle cannula and said limiter. 29. A method as set forth in claim 28 further including the step of exposing the tip of said barrel before attaching said needle assembly thereto by removing a cap from said tip of said barrel. 30. A method as set forth in claim 20 wherein said animal is human. 31. A method as set forth in claim 24 wherein said step of inserting said forward tip of said needle into the skin of the animal is further defined by simultaneously grasping said hypodermic needle with a first hand and pressing said limiter against the skin of the animal thereby stretching the skin of the animal. 32. A method as set forth in claim 31 wherein said step of expelling the substance is further defined by depressing said plunger with an index finger of the first hand. 33. A method as set forth in claim 31 wherein said step of expelling the substance is further defined by depressing said plunger with a thumb of the first hand. 34. A method as set forth in claim 20 further including the step of withdrawing said forward tip of said needle cannula from the skin of the animal after the substance has been injected into the skin of the animal. 35. A method as set forth in claim 20 wherein said step of inserting said forward tip into the skin is further defined by inserting said forward tip into the skin to a depth of from approximately 1.0 mm to approximately 2.0 mm. 36. A method as set forth in claim 35 wherein said step of inserting said forward tip into the skin is further defined by inserting said forward tip into the skin to a depth of 1.5 mm.+-.0.2 mm to 0.3 mm. 37. A method as set forth in claim 20 wherein said step of exposing said forward tip of said needle cannula is further defined by removing a cap from said delivery device. 38. A method as set forth in claim 20 wherein said substance is selected from the group consisting of drugs, vaccines and the like used in the prevention, diagnosis, alleviation, treatment, or cure of disease. 39. A method as set forth in claim 38 wherein said drugs include Alpha-i anti-trypsin, Anti-Angiogenesis agents, Antisense, butorphanol, Calcitonin and analogs, Ceredase, COX-II inhibitors, dermatological agents, dihydroergotamine, Dopamine agonists and antagonists, Enkephalins and other opioid peptides, Epidermal growth factors, Erythropoietin and analogs, Follicle stimulating hormone, G-CSF, Glucagon, GM-CSF, granisetron, Growth hormone and analogs (including growth hormone releasing hormone), Growth hormone antagonists, Hirudin and Hirudin analogs such as hirulog, IgE suppressors, Insulin, insulinotropin and analogs, Insulin-like growth factors, Interferons, Interleukins, Leutenizing hormone, Leutenizing hormone releasing hormone and analogs, Low molecular weight heparin, M-CSF, metoclopramide, Midazolam, Monoclonal antibodies, Narcotic analgesics, nicotine, Non-steroid anti-inflammatory agents, Oligosaccharides, ondansetron, Parathyroid hormone and analogs, Parathyroid hormone antagonists, Prostaglandin antagonists, Prostaglandins, Recombinant soluble receptors, scopolamine, Serotonin agonists and antagonists, Sildenafil, Terbutaline, Thrombolytics, Tissue plasminogen activators, TNF--, and TNF--antagonist, said vaccines, with or without carriers/adjuvants, include prophylactics and therapeutic antigens (including but not limited to subunit protein, peptide and polysaccharide, polysaccharide conjugates, toxoids, genetic based vaccines, live attenuated, reassortant, inactivated, whole cells, viral and bacterial vectors) in connection with, addiction, arthritis, cholera, cocaine addiction, diphtheria, tetanus, HIB, Lyme disease, meningococcus, measles, mumps, rubella, varicella, yellow fever, Respiratory syncytial virus, tick borne japanese encephalitis, pneumococcus, streptococcus, typhoid, influenza, hepatitis, including hepatitis A, B, C and E, otitis media, rabies, polio, HIV, parainfluenza, rotavirus, Epstein Barr Virus, CMV, chlamydia, non-typeable haemophilus, moraxella catarrhalis, human papilloma virus, tuberculosis including BCG, gonorrhoea, asthma, atheroschlerosis malaria, E-coli, Alzheimers, H. Pylori, salmonella, diabetes, cancer, herpes simplex, human papilloma and like other substances include all of the major therapeutics such as agents for the common cold, Anti-addiction, anti-allergy, anti-emetics, anti-obesity, antiosteoporeteic, anti-infectives, analgesics, anesthetics, anorexics, antiarthritics, antiasthmatic agents, anticonvulsants, anti-depressants, antidiabetic agents, antihistamines, anti-inflammatory agents, antimigraine preparations, antimotion sickness preparations, antinauseants, antineoplastics, antiparkinsonism drugs, antipruritics, antipsychotics, antipyretics, anticholinergics, benzodiazepine antagonists, vasodilators, including general, coronary, peripheral and cerebral, bone stimulating agents, central nervous system stimulants, hormones, hypnotics, immunosuppressives, muscle relaxants, parasympatholytics, parasympathomimetrics, prostaglandins, proteins, peptides, polypeptides and other macromolecules, psychostimulants, sedatives, sexual hypofunction and tranquilizers and major diagnostics such as tuberculin and other hypersensitivity agents. 40. A method as set forth in claim 38 wherein said substance comprises an influenza vaccine. 41. A method as set forth in claim 38 wherein said substance comprises a hepatitis B vaccine. 42. A method as set forth in claim 38 wherein said substance comprises a rabies vaccine. 43. A method as set forth in claim 38 wherein said substance comprises a cancer vaccine. 44. A method as set forth in claim 38 wherein said substance comprises a genetic based vaccine. 45. A method as set forth in claim 38 wherein said substance comprises a tuberculin test substance. 46. A method of making an intradermal injection into the skin of an animal comprising the steps of: providing a drug delivery device with a prefillable container including a needle cannula having a forward needle tip and said needle cannula being in fluid communication with a substance contained in said prefillable container and including a limiter portion surrounding said needle cannula and said limiter portion including a skin engaging surface, with said needle tip of said needle cannula extending from said limiter portion beyond said skin engaging surface and said needle cannula having a fixed angle of orientation relative to a plane of the skin engaging surface of the limiter portion; inserting said needle tip into the skin of an animal and engaging the surface of the skin with said skin engaging surface of said limiter portion such that the skin engaging surface of the limiter portion limits penetration of the needle tip into the dermis layer of the skin of the animal; and expelling the substance from said drug delivery device through the needle tip into the skin of the animal. 47. A method as set forth in claim 46 wherein said step of inserting said forward tip into the skin of the animal is further defined by inserting said forward tip into the skin at an angle being generally perpendicular to the skin within about fifteen degrees. 48. A method as set forth in claim 47 wherein said step of inserting said forward tip into the skin of the animal is further defined by inserting said forward tip into the skin at an angle of generally ninety degrees to the skin within about five degrees. 49. A method as set forth in claim 46 wherein said limiter portion has a generally flat skin engaging surface surrounding said needle tip having an outside diameter of at least 5 mm. 50. A method as set forth in claim 49 wherein said step of providing a limiter portion is further defined by said forward tip of said needle cannula extending beyond said skin engaging surface a distance equal to approximately 0.5 mm to approximately 3.0 mm. 51. A method as set forth in claim 50 wherein said drug delivery device comprises a syringe having a barrel and a plunger received within said barrel therein and said plunger being depressable to expel said substance from said barrel through said needle cannula. 52. A method as set forth in claim 51 wherein said step of expelling the substance from said prefillable container is further defined by grasping said delivery device with a first hand and depressing said plunger with an index finger of a second hand. 53. A method as set forth in claim 51 wherein said step of expelling the substance from said prefillable container is further defined by grasping said delivery device with a first hand and depressing said plunger with a thumb of a second hand. 54. A method as set forth in claim 51 further including the step of inserting said forward tip into the skin of the animal is further defined by depressing the skin of the animal with said limiter until the skin becomes stretched. 55. A method as set forth in claim 51 wherein said step of inserting said needle tip into the skin of an animal if further defined by engaging the surface of the skin with a substantially flat skin engaging surface of said limiter portion. 56. A method as set forth in claim 51 further including the step of attaching a needle assembly to a tip of said barrel of said syringe with said needle assembly including said needle cannula and said limiter portion. 57. A method as set forth in claim 56 further including the step of exposing the tip of said barrel before attaching said needle assembly thereto by removing a cap from said tip of said barrel. 58. A method as set forth in claim 51 wherein said barrel of said syringe is made of glass. 59. A method as set forth in claim 51 wherein said animal is human. 60. A method as set forth in claim 46 further including the steps of selecting an injection sight on the skin of the animal and cleaning the injection sight prior to expelling the substance from the drug delivery device into the skin of the animal. 61. A method as set forth in claim 46 further including the step of withdrawing said forward tip of said needle cannula from the skin of the animal after the substance has been injected into the skin of the animal. 62. A method as set forth in claim 46 further comprising the step of filling the prefillable container of said drug delivery device with the substance. 63. A method as set forth in claim 46 wherein said step of inserting said forward tip into the skin is further defined by inserting said forward tip into the skin to a depth of from approximately 1.0 mm to approximately 2.0 mm. 64. A method as set forth in claim 46 wherein said step of inserting said forward tip into the skin is further defined by inserting said forward tip into the skin to a depth of 1.5 mm.+-.0.2 mm to 0.3 mm. 65. A method as set forth in claim 46 wherein said substance is selected from the group consisting of drugs, vaccines and the like used in the prevention, diagnosis, alleviation, treatment, or cure of diseases. 66. A method as set forth in claim 65 wherein said substance comprises an influenza vaccine. 67. A method as set forth in claim 65 wherein said substance comprises a hepatitis B vaccine. 68. A method as set forth in claim 65 wherein said substance comprises a rabies vaccine. 69. A method as set forth in claim 65 wherein said substance comprises a cancer vaccine. 70. A method as set forth in claim 65 wherein said substance comprises a pneumococcus vaccine or streptococcus vaccine. 71. A method as set forth in claim 65 wherein said substance comprises a tuberculin test substance. 72. A method as set forth in claim 65 wherein said substance comprises a genetic based vaccines. 73. A method of intradermally injecting an influenza vaccine into the skin of an animal comprising the steps of: providing a drug delivery device including a needle cannula having a forward needle tip and said needle cannula being in fluid communication with an influenza vaccine contained in said drug delivery device and including a limiter portion surrounding said needle cannula and said limiter portion including a skin engaging surface, with said needle tip of said needle cannula extending from said limiter portion beyond said skin engaging surface a distance equal to approximately 0.5 mm to approximately 3.0 mm and said needle cannula having a fixed angle of orientation relative to a plane of the skin engaging surface of the limiter portion; inserting said needle tip into the skin of an animal and engaging the surface of the skin with said skin engaging surface of said limiter portion such that the skin engaging surface of the limiter portion limits penetration of the needle tip into the dermis layer of the skin of the animal; and expelling the influenza vaccine from said drug delivery device through the needle tip into the skin of the animal. 74. A method as set forth in claim 73 wherein said fixed angle of orientation of said needle cannula is further defined as being generally perpendicular to said plane of said skin engaging surface of the limiter portion within about fifteen degrees. 75. A method as set forth in claim 74 wherein said fixed angle of orientation of said needle cannula is further defined as being ninety degrees relative to said plane of the skin engaging surface of the limiter portion within about five degrees. 76. A method as set forth in claim 73 wherein said drug delivery device comprises a syringe having a barrel and a plunger received within said barrel therein and plunger being depressable to expel said substance from said delivery device through the tip of said needle cannula. 77. A method as set forth in claim 76 wherein said barrel includes a barrel tip and said needle cannula forms part of a needle assembly attachable to and in fluid communication with said barrel tip. 78. A method as set forth in claim 76 wherein said barrel is made of glass. 79. A method as set forth in claim 73 further comprising the step of filling the drug delivery device with the influenza vaccine. 80. A method as set forth in claim 73 wherein said step of inserting said forward tip into the skin is further defined by inserting said forward tip into the skin to a depth of from approximately 1.0 mm to approximately 2.0 mm. 81. A method as set forth in claim 73 wherein said step of inserting said forward tip into the skin is further defined by inserting said forward tip into the skin to a depth of 1.5 mm.+-.0.2 mm to 0.3 mm. 82. A method as set forth in claim 73, wherein said drug delivery device is a cylindrical container having a reciprocal stopper and wherein said cylindrical container has an inside diameter large enough to generate a force sufficient to overcome the back pressure of the dermis during injection.

Details for Patent 6,569,143

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bavarian Nordic A/s	RABAVERT	rabies vaccine	For Injection	103334	10/20/1997		2019-10-14
Sanofi Pasteur Sa	IMOVAX RABIES	rabies vaccine	For Injection	103931	02/04/2000		2019-10-14
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2019-10-14