Claims for Patent: 9,821,116

Summary for Patent: 9,821,116

Title:	Fluid dispenser
Abstract:	A fluid dispensing device is provided for dispensing a measured amount of fluid into a living organism. The device has a needle having a first end and a second end. The needle is adapted for interfacing, on the first end, with a septum of a flexible hollow membrane, and at a second end thereof, for subcutaneously inserting into a living organism. The needle is guided by a guide to permit an injection into the living organism at a substantially non-orthogonal angle with respect to a surface of the living organism. The first and second ends of the needle pierce their respective piercing surface while translating together in a common direction. In other embodiments, the dispensing device includes a main housing, a flexible fluid reservoir, an injection assembly and a trigger mechanism. The main housing houses the operative components of the device.
Inventor(s):	Vouillamoz; Lucien (Feusisberg, CH), Rosen; Melissa (Salem, MA), Walish; Judy L. (Brighton, MA), Yasevac; Daniel (Somerville, MA), Bruehwiler; Michel (Newton, MA)
Assignee:	Preciflex SA (Biel/Bienne, CH)
Application Number:	14/235,107
Patent Claims:	1. A fluid dispensing device for dispensing a measured amount of fluid in a membrane into a living organism, the device having a needle having a first proximal end and a second distal end and a septum-stop, the needle interfacing, on the first proximal end, with a septum, and at the second distal end thereof, the needle free to translate in a first direction during which translation the needle is deformed through a guide which bends the needle at its distal end as the needle translates through the guide and, when in its operational position, the needle is positioned for subcutaneous insertion, and wherein the first proximal end of the needle is lodged into the septum-stop after piercing the septum, thereby ensuring that the membrane does not expand and so does not aspirate, and wherein further the needle is malleable such that it deforms during injection so as to function only for a single use. 2. The dispensing device of claim 1, wherein the second end of the needle is guided by the guide to be bent to an insertion angle permitting an injection into the living organism at a substantially non-orthogonal angle with respect to a surface of the living organism. 3. The device of claim 1, wherein the device is adapted for dispensing a fluid selected from one of a group of fluids consisting of peptides, proteins, hormones including insulin, calcitonin, calcitonin gene regulating protein, atrial natriuretic protein, colony stimulating factor, betaseron, erythropoietin (EPO), interferons including .alpha., .beta. or .gamma. interferon, somatropin, somatotropin, somastostatin, insulin-like growth factor (somatomedins), luteinizing hormone releasing hormone (LHRH), tissue plasminogen activator (TPA), growth hormone releasing hormone (GHRH), oxytocin, estradiol, growth hormones, leuprolide acetate, factor VIII, interleukins including interleukin-2, and analogues or antagonists thereof, including IL-1ra; analgesics including fentanyl, sufentanil, butorphanol, buprenorphine, levorphanol, morphine, hydromorphone, hydrocodone, oxymorphone, methadone, lidocaine, bupivacaine, diclofenac, naproxen, paverin, and analogues thereof; anti-migraine agents including sumatriptan, ergot alkaloids, and analogues thereof; anti-coagulant agents i including heparin, hirudin, and analogues thereof; anti-emetic agents including scopolamine, ondansetron, domperidone, metoclopramide, and analogues thereof; cardiovacular agents, anti-hypertensive agents and vasodilators including diltiazem, clonidine, nifedipine, verapamil, isosorbide-5-monotritate, organic nitrates, agents used in treatment of heart disorders, and analogues thereof; sedatives including benzodiazepines, phenothiazines, and analogues thereof; chelating agents including defroxanune, and analogues thereof; anti-diuretic agents including desmopressin, vasopressin, and analogues thereof; anti-anginal agents including fluorouracil, bleomycin, and analogues thereof; anti-neoplastics including fluorouracil, bleomycin, and analogues thereof; prostaglandins and analogues thereof; and chemotherapy agents including vincristine, and analogues thereof, treatments for attention deficit disorder, methylphenidate, fluvoxamine, bisoprolol, tacrolimus, sacrolimus and cyclosporin, vitamins suspended in a liquid carrier, antivenoms, syrums, medications, antibodies, tocilizumab, brentuximab vedotin, ofatumumab, bevacizumab, belimumab, certolizumab pegol, cetuximab, trastuzumab, adalimumab, canakinumab, ranibizumab, gemtuzumab ozogamicin, pertuzumab, denosumab, infliximab, golimumab, eculizumab, ustekinumab, natalizumab, panitumumab, denosumab, omalizumab, ipilimumab, and ibritumomab tiuxetan. 4. The device of claim 1, wherein the fluid dispensing device further has an indicator which indicates that the injection is complete. 5. A method of subcutaneously administering a fluid to a living organism, the method, using the fluid dispensing device of claim 1, including the steps of: a. with a first end of the needle, penetrating through a septum in a fluid reservoir; b. filling the needle; c. with the second end of the needle, penetrating the skin of the living organism; d. injecting a prescribed amount of fluid into the living organism at a prescribed depth of skin penetration; e. with the first end of the needle, plunging into a septum-stop while the second end of the needle continues to penetrate the skin of the living organism, the lodging of the first proximal end of the needle into the septum-stop thereby ensuring that the membrane does not expand and so does not aspirate, and wherein further the needle is malleable such that it deforms during injection so as to function only for a single-use; f. retracting the needle from the living organism into an enclosed space; and g. optionally disposing of the fluid dispensing device. 6. A flexible fluid membrane adapted for use in the device of claim 1, the membrane including: a. a first proximal end including the septum; and b. the second distal end including the septum-stop. 7. The membrane of claim 6, the membrane having a form selected to control the amount of fluid injected during the course of the injection process. 8. A method of subcutaneously administering a fluid to a living organism, the method, using the fluid dispensing device having a needle having a first proximal end and a second distal end and a septum-stop, the needle adapted for interfacing, on the first proximal end, with a septum, and at the second distal end thereof, for subcutaneously inserting into a living organism while translating in a first direction during which translation the needle is deformed through a guide which bends the needle at its distal end as the needle translates through the guide, the method including the steps of: a. the second end of needle travels through the guide which deforms the needle as the needle travels at least 2 mm into skin of the living organism; b. first end of the needle penetrates through a septum in a fluid reservoir; c. the needle is filled with fluid; d. a prescribed amount of fluid is injected into the living organism at a prescribed depth of skin penetration; e. the needle further translates causing fluid flow to be blocked as the first end of the needle penetrates into the septum-stop; f. the needle is retracted from the living organism into an enclosed space; and g. the fluid dispensing device is disposed of.

Details for Patent 9,821,116

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	06/23/1987		2031-07-25
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10/16/1986		2031-07-25
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	02/04/1999		2031-07-25
Emd Serono, Inc.	SAIZEN	somatropin	For Injection	019764	10/08/1996		2031-07-25
Emd Serono, Inc.	SAIZEN	somatropin	For Injection	019764	08/29/2000		2031-07-25
Emd Serono, Inc.	SAIZEN	somatropin	For Injection	019764	01/16/2007		2031-07-25
Ferring Pharmaceuticals Inc.	ZOMACTON	somatropin	For Injection	019774	05/25/1995		2031-07-25