Patents by Inventor Mark Destefano
Mark Destefano has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).
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Publication number: 20230270934Abstract: An insertion mechanism for a drug pump includes an insertion mechanism housing; a sleeve; a rotational biasing member initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the sleeve. The needle is inserted into a target tissue by the rotational biasing member and interaction between the hub and housing. Retraction of the needle is caused by decompressing or de-energizing of the retraction biasing member. A drug delivery pump includes an activation mechanism, a drive mechanism, a sterile access connection, and the insertion mechanism. Assembly and operation methods are provided.Type: ApplicationFiled: May 8, 2023Publication date: August 31, 2023Inventors: Mark A. Destefano, Lawton Laurence, John C. Love, Ian B. Hanson, Paul F. Bente, IV
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Patent number: 11738138Abstract: An insertion mechanism for a drug pump includes an insertion mechanism housing; a sleeve; a rotational biasing member initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the sleeve. The needle is inserted into a target tissue by the rotational biasing member and interaction between the hub and housing. Retraction of the needle is caused by decompressing or de-energizing of the retraction biasing member. A drug delivery pump includes an activation mechanism, a drive mechanism, a sterile access connection, and the insertion mechanism. Assembly and operation methods are provided.Type: GrantFiled: March 16, 2020Date of Patent: August 29, 2023Assignee: AMGEN INC.Inventors: Mark A. Destefano, Lawton Laurence, John C. Love, Ian B. Hanson, Paul F. Bente, IV
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Patent number: 11672905Abstract: An insertion mechanism for a drug pump includes an insertion mechanism housing; a sleeve; a rotational biasing member initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the sleeve. The needle is inserted into a target tissue by the rotational biasing member and interaction between the hub and housing. Retraction of the needle is caused by decompressing or de-energizing of the retraction biasing member. A drug delivery pump includes an activation mechanism, a drive mechanism, a sterile access connection, and the insertion mechanism. Assembly and operation methods are provided.Type: GrantFiled: November 18, 2020Date of Patent: June 13, 2023Assignee: AMGEN INC.Inventors: Mark A. Destefano, Lawton Laurence, John C. Love, Ian B. Hanson, Paul F. Bente, IV
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Publication number: 20220218900Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.Type: ApplicationFiled: March 7, 2022Publication date: July 14, 2022Inventors: Scott R. Gibson, Sheldon B, Moberg, Basel Hasan Taha, Margaux Frances Boyaval, Mark A. Destefano, John C. Love, Ian B. Hanson, Paul F. Bente, IV, Matthew J. Clemente, Rajan Ramaswamy, Daniel S. Codd, Scott Beaver, Kevin L. Bokelman, Sean M. O'connor, Robert Decker, Gautam N. Shetty, Ryan M. Agard, Nicholas J. Ciccarelli, Daniel Davenport
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Patent number: 11266777Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.Type: GrantFiled: February 13, 2017Date of Patent: March 8, 2022Assignee: AMGEN INC.Inventors: Scott R. Gibson, Sheldon B. Moberg, Basel Hasan Taha, Margaux Frances Boyaval, Mark A. Destefano, John C. Love, Ian B. Hanson, Paul F. Bente, IV, Matthew J. Clemente, Rajan Ramaswamy, Daniel S. Codd, Scott Beaver, Kevin L. Bokelman, Sean M. O'connor, Robert Decker, Gautam N. Shetty, Ryan M. Agard, Nicholas J. Ciccarelli, Daniel Davenport
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Publication number: 20220054741Abstract: A drive mechanism (100) for use with a drug container (50) in a drug pump, the drug container (50) having a barrel (58) and a plunger seal (60), including a tether, an electrical actuator (101) and a gear interface. Rotation of the gear interface is controlled by the actuator (101). A gear assembly rotationally engages with the gear interface. The gear assembly includes a main gear and a regulating mechanism. Release of the tether is metered by the gear assembly through the regulating mechanism. A piston (110, 1110, 2110) is connected to the tether and is disposed in the barrel (58) and configured to translate axially within the container. A biasing member is disposed at least partially within the barrel (58) and is retained in an energized state between the piston (110, 1110, 2110) and drive housing, wherein the release of the tether controls the free expansion of the biasing member from its energized state and the axial translation of the piston (110, 1110, 2110).Type: ApplicationFiled: October 15, 2021Publication date: February 24, 2022Inventors: Lawton Laurence, Paul F. Bente, IV, Mark A. Destefano, Ian P. Dardani, Ian B. Hanson
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Publication number: 20210402084Abstract: A system for delivering fluid to a user transcutaneously includes a torsion spring, a drive wheel, a linear slide having a stylet attached thereto, and a cannula. The torsion spring, when actuated, is configured to rotate the drive wheel to cause the linear slide to move axially to drive the stylet and cannula into a user-s skin.Type: ApplicationFiled: November 8, 2019Publication date: December 30, 2021Applicant: CAPILLARY BIOMEDICAL, INC.Inventors: Justin COKER, Mark A. DeSTEFANO, Kenneth C. HSU, Amber STANSBERRY, Paul STRASMA, David GILLETT, Mark ESTES, Amrith KARUNARATNE
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Publication number: 20210402083Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.Type: ApplicationFiled: July 28, 2021Publication date: December 30, 2021Inventors: Scott R. Gibson, Sheldon B. Moberg, Basel Hasan Taha, Margaux Frances Boyaval, Mark A. Destefano, Lawton Laurence, John C. Love, Ian B. Hanson, Paul F. Bente, IV, Matthew J. Clemente, Antonio Ubach, Rajan Ramaswamy, Daniel S. Codd, Scott Beaver, Kevin L. Bokelman, Ian P. Dardani, Sean M. O'connor, Danielle Feldman
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Patent number: 11167082Abstract: A drive mechanism (100) for use with a drug container (50) in a drug pump, the drug container (50) having a barrel (58) and a plunger seal (60), including a tether, an electrical actuator (101) and a gear interface. Rotation of the gear interface is controlled by the actuator (101). A gear assembly rotationally engages with the gear interface. The gear assembly includes a main gear and a regulating mechanism. Release of the tether is metered by the gear assembly through the regulating mechanism. A piston (110, 1110, 2110) is connected to the tether and is disposed in the barrel (58) and configured to translate axially within the container. A biasing member is disposed at least partially within the barrel (58) and is retained in an energized state between the piston (110, 1110, 2110) and drive housing, wherein the release of the tether controls the free expansion of the biasing member from its energized state and the axial translation of the piston (110, 1110, 2110).Type: GrantFiled: March 9, 2016Date of Patent: November 9, 2021Assignee: AMGEN INC.Inventors: Lawton Laurence, Paul F. Bente, IV, Mark A. Destefano, Ian P. Dardani, Ian B. Hanson
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Patent number: 11129936Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device includes a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector defines a sterile fluid flowpath between the container and the insertion mechanism. A cannula initially disposed about the needle is included.Type: GrantFiled: April 7, 2017Date of Patent: September 28, 2021Assignee: AMGEN INC.Inventors: Scott R. Gibson, Sheldon B. Moberg, Basel Hasan Taha, Margaux Frances Boyaval, Mark A. Destefano, Lawton Laurence, John C. Love, Ian B. Hanson, Paul F. Bente, IV, Matthew J. Clemente, Antonio Ubach, Rajan Ramaswamy, Daniel S. Codd, Scott Beaver, Kevin L. Bokelman, Ian P. Dardani, Sean M. O'connor, Danielle Feldman
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Publication number: 20210128830Abstract: A controlled delivery drive mechanism includes a drive housing, a piston, and a biasing member initially retained in an energized state and is configured to bear upon an interface surface of the piston. The piston is configured to translate a plunger seal and a barrel. A tether is connected between the piston and the winch drum to restrain the free expansion of the biasing member and the free axial translation of the piston upon which the biasing member bears upon. The drive mechanism may further include a gear assembly and an escapement regulating mechanism configured to control the rotation of the gear assembly to release the tether from the winch drum. The metering of the tether by the escapement regulating mechanism controls the rate or profile of drug delivery to a user.Type: ApplicationFiled: June 15, 2020Publication date: May 6, 2021Inventors: Ian B. Hanson, Paul F. Bente, IV, Mark A. Destefano
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Publication number: 20210069410Abstract: An insertion mechanism for a drug pump includes an insertion mechanism housing; a sleeve; a rotational biasing member initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the sleeve. The needle is inserted into a target tissue by the rotational biasing member and interaction between the hub and housing. Retraction of the needle is caused by decompressing or de-energizing of the retraction biasing member. A drug delivery pump includes an activation mechanism, a drive mechanism, a sterile access connection, and the insertion mechanism. Assembly and operation methods are provided.Type: ApplicationFiled: November 18, 2020Publication date: March 11, 2021Inventors: Mark A. Destefano, Lawton Laurence, John C. Love, Ian B. Hanson, Paul F. Bente, IV
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Patent number: 10806854Abstract: An insertion mechanism for a drug pump includes an insertion mechanism housing; a manifold guide; an insertion biasing members initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the manifold guide; and a manifold having a septum and a cannula, wherein the annular space between the septum and the cannula defines a manifold header. The needle and cannula are inserted into the body of a user by the insertion biasing member(s), after which only the needle is retracted. Retraction of the needle may open a fluid pathway from the manifold header to the body through the cannula. A drug delivery pump includes an activation mechanism, a drive mechanism, a fluid pathway connection, and the insertion mechanism. Assembly and operation methods are provided.Type: GrantFiled: December 5, 2016Date of Patent: October 20, 2020Assignee: UNL Holdings LLCInventors: Sean M. O'Connor, Robert Decker, Gautam N. Shetty, Mark A. DeStefano, Ian B. Hanson, Paul F. Bente, IV
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Patent number: 10806855Abstract: An insertion mechanism and methods of assembly and operation of a drug pump may include an insertion mechanism housing; a housing cap; a manifold guide; an insertion biasing member initially held in an energized state; a retraction biasing member connected to a hub connected to a proximal end of a needle; and, optionally, a clip retainer. The retraction biasing member is held initially in an energized state between the hub and manifold guide. A manifold has a manifold body and one or more septa defining a manifold header. The retraction biasing member may be held initially energized between the hub and the clip retainer. The needle is advanced by the insertion biasing member(s) from the initial configuration to an administration configuration, opening a fluid pathway from the manifold header to the target. The pump may include an activation mechanism, a drive mechanism, a fluid pathway connection, and the insertion mechanism.Type: GrantFiled: September 29, 2015Date of Patent: October 20, 2020Assignee: UNL HOLDINGS LLCInventors: Mark Destefano, Ian Hanson, Paul Bente, Lawton Laurence
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Publication number: 20200316291Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device includes a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector defines a sterile fluid flowpath between the container and the insertion mechanism. A cannula initially disposed about the needle is included.Type: ApplicationFiled: April 7, 2017Publication date: October 8, 2020Inventors: Scott Robert Gibson, Sheldon B. Moberg, Basel Hasan Taha, Margaux Frances Boyaval, Mark A. Destefano, Lawton Laurence, John C. Love, Ian B. Hanson, Paul F. Bente, IV, Matthew J. Clemente, Antonio Ubach, Rajan Ramaswamy, Daniel S. Codd, Scott Beaver, Kevin L. Bokelman, Ian P. Dardani, Sean M. O'connor, Danielle Feldman
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Publication number: 20200222624Abstract: An insertion mechanism for a drug pump includes an insertion mechanism housing; a sleeve; a rotational biasing member initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the sleeve. The needle is inserted into a target tissue by the rotational biasing member and interaction between the hub and housing. Retraction of the needle is caused by decompressing or de-energizing of the retraction biasing member. A drug delivery pump includes an activation mechanism, a drive mechanism, a sterile access connection, and the insertion mechanism. Assembly and operation methods are provided.Type: ApplicationFiled: March 16, 2020Publication date: July 16, 2020Inventors: Mark A. Destefano, Lawton Laurence, John C. Love, Ian B. Hanson, Paul F. Bente, IV
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Patent number: 10695487Abstract: A controlled delivery drive mechanism includes a drive housing, a piston, and a biasing member initially retained in an energized state and is configured to bear upon an interface surface of the piston. The piston is configured to translate a plunger seal and a barrel. A tether is connected between the piston and the winch drum to restrain the free expansion of the biasing member and the free axial translation of the piston upon which the biasing member bears upon. The drive mechanism may further include a gear assembly and an escapement regulating mechanism configured to control the rotation of the gear assembly to release the tether from the winch drum. The metering of the tether by the escapement regulating mechanism controls the rate or profile of drug delivery to a user.Type: GrantFiled: August 30, 2017Date of Patent: June 30, 2020Assignee: UNL Holdings LLCInventors: Ian B. Hanson, Paul F. Bente, IV, Mark A. Destefano
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Publication number: 20200179596Abstract: A fill-finish cartridge includes a carrier, a fluid pathway connection, a needle insertion mechanism, and a drug container. The cartridges enable drug containers to be filled with pharmaceutical treatments using standard filling equipment and process systems, while maintaining the sterility and container integrity of the fluid pathway. The fill-finish cartridges of the present invention can be nested or removably housed in fill-finish trays for batch filling in standard operating processes. As such, the adaptable fillfinish cartridges of the present invention may be flexibly inserted, attached, mounted, or otherwise removably positioned in fill-finish trays. These embodiments, accordingly, may provide novel and cost-efficient assemblies and cartridges which are readily integrated into drug filling processes. Methods of assembly, manufacture, and use are also provided.Type: ApplicationFiled: June 6, 2017Publication date: June 11, 2020Inventors: Alexis Marie Adolphe Dechelette, Shaun R. Devitt, Robert G. Jeter, Jr., Lawton Laurence, Mark A. Destefano
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Patent number: 10625018Abstract: An insertion mechanism (200) for a drug pump (10, 1300) includes an insertion mechanism (200) housing (202, 1202, 2202, 3202); a sleeve (220, 1220, 2220, 3220); a rotational biasing member (210, 1210, 2210, 3210) initially held in an energized state; a retraction biasing member (216, 1216, 2216, 3216) and a hub (212, 1212, 2212, 3212) connected to a proximal end of a needle (214, 1214, 2214, 3214), wherein the retraction biasing member (216, 1216, 2216, 3216) is held initially in an energized state between the hub (212, 1212, 2212, 3212) and the sleeve (220, 1220, 2220, 3220). The needle (214, 1214, 2214, 3214) is inserted into a target tissue by the rotational biasing member (210, 1210, 2210, 3210) and interaction between the hub (212, 1212, 2212, 3212) and housing (202, 1202, 2202, 3202). Retraction of the needle (214, 1214, 2214, 3214) is caused by decompressing or de-energizing of the retraction biasing member (216, 1216, 2216, 3216).Type: GrantFiled: February 10, 2016Date of Patent: April 21, 2020Assignee: AMGEN INC.Inventors: Mark A. Destefano, Lawton Laurence, John C. Love, Ian B. Hanson, Paul F. Bente, IV
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Publication number: 20190022306Abstract: Disclosed herein is a wearable drug delivery device including a container filled at least partially with a drug including at least one of a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) specific antibody, a granulocyte colony-stimulating factor (G-CSF), a sclerostin antibody, or a calcitonin gene-related peptide (CGRP) antibody. The wearable drug delivery device may include a needle and an insertion mechanism configured to insert the needle into a patient. A fluid pathway connector may define a sterile fluid flowpath between the container and the insertion mechanism. Optionally, a cannula initially disposed about the needle may be included. The cannula may be retained in the patient at an injection site created by the needle after the needle is withdrawn from the patient. Methods of assembly and operation are also provided.Type: ApplicationFiled: February 13, 2017Publication date: January 24, 2019Applicant: Amgen Inc.Inventors: Scott R. GIBSON, Sheldon B. MOBERG, Basel Hasan TAHA, Margaux Frances BOYAVAL, Mark A. DESTEFANO, John C. LOVE, Ian B. HANSON, Paul F. BENTE, IV, Matthew J. CLEMENTE, Rajan RAMASWAMY, Daniel S. CODD, Scott BEAVER, Kevin L. BOKELMAN, Sean M. O'CONNOR, Robert DECKER, Gautam N. SHETTY, Ryan M. AGARD, Nicholas J. CICCARELLI, Daniel DAVENPORT