Claims for Patent: 9,956,353

Summary for Patent: 9,956,353

Title:	Shroud deployment in automatic injection devices
Abstract:	Exemplary embodiments provide automatic injection devices in which a shroud is automatically deployed to protectively sheath a needle after an injection is performed. Exemplary embodiments also provide shroud deployment assemblies including a shroud and a syringe carrier that, when cooperatively configured in an automatic injection device, ensure that the shroud is automatically and completely deployed after an injection is performed using the automatic injection device. Exemplary embodiments are also configured to ensure that, once the shroud is deployed to an extended position to sheath the needle, accidental forces applied to the shroud do not succeed in subsequently retracting the shroud to a retracted position in which the needle would become exposed.
Inventor(s):	Rao; Vivek (Alameda, CA), Shang; Sherwin (Vernon Hills, IL), Ozdaryal; Esra (Deerfield, IL), Tsvirko; Eduard (Arlington Heights, IL), Chim; Edwin (Vernon Hills, IL), Post; David (Kenosha, WI), Dipalma; Vincent (Hayward, CA)
Assignee:	AbbVie Inc. (North Chicago, IL)
Application Number:	14/007,849
Patent Claims:	1. A shroud deployment assembly for use in an automatic injection device, the shroud deployment assembly comprising: a shroud disposed within an internal bore of a housing of the automatic injection device, the shroud movable between a retracted position and an extended position relative to the housing, the shroud comprising: a tubular member extending between a proximal end and a distal end, and one or more arms extending from the distal end of the tubular member; and a syringe carrier coupled to and disposed partly within the tubular member of the shroud, the syringe carrier comprising a cylindrical portion having a slot forming a trench in an outer surface of the cylindrical portion extending along a length of the syringe carrier; wherein, as the shroud is deployed from the retracted position to the extended position, the one or more arms of the shroud move forwardly within a constrained space formed between an inner surface of the housing of the automatic injection device and an outer surface of the cylindrical portion of the syringe carrier to engage with the trench as they move forwardly; and wherein the trench is configured to facilitate smooth movement of the one or more arms of the shroud within the constrained space during deployment of the shroud. 2. The shroud deployment assembly of claim 1, wherein the height of the constrained space is configured to be at least equal to a thickness of the one or more arms of the shroud. 3. The shroud deployment assembly of claim 1, wherein an outer diameter of the cylindrical portion of the syringe carrier is configured to range from about 13.0 mm to about 14.0 mm. 4. The shroud deployment assembly of claim 1, wherein a thickness of the one or more arms of the shroud is configured to reduce a pinching effect of the one or more arms during movement of the one or more arms in the constrained space. 5. The shroud deployment assembly of claim 4, wherein the thickness of the one or more arms of the shroud is configured to be at most equal to the height of the constrained space. 6. The shroud deployment assembly of claim 5, wherein the thickness of the one or more arms of the shroud is configured to range from about 1.3 mm to about 1.4 mm. 7. The shroud deployment assembly of claim 1, wherein an inner diameter of the housing of the automatic injection device is configured to range from about 17 mm to about 18 mm. 8. The shroud deployment assembly of claim 1, wherein the cylindrical portion of the syringe carrier comprises: a proximal tubular portion having a first outer diameter; a distal tubular portion having a second outer diameter less than the first diameter; and a chamfered relief formed between the proximal and distal tubular portions. 9. The shroud deployment assembly of claim 8, wherein the chamfered relief has an angle ranging from about 5 degrees to about 60 degrees. 10. The shroud deployment assembly of claim 1, wherein the trench has a depth ranging from about 0.1 mm to about 0.5 mm. 11. The shroud deployment assembly of claim 1, wherein the shroud, in the extended position, protectively sheathes a needle disposed at a proximal end of the automatic injection device, and wherein the shroud, in the retracted position, allows exposure of a needle disposed at a proximal end of the automatic injection device. 12. The shroud deployment assembly of claim 1, wherein, once the shroud is deployed to the extended position, the shroud is configured to withstand a force of at least 80 N without retracting to the retracted position. 13. The shroud deployment assembly of claim 1, further comprising: a biasing mechanism that is in a compressed state when the shroud is in the retracted position and that automatically biases the shroud from the retracted position to the extended position after the automatic injection device is removed from an injection site. 14. The shroud deployment assembly of claim 1, wherein the automatic injection device comprises a dose of a TNF.alpha. inhibitor. 15. The shroud deployment assembly of claim 14, wherein the TNF.alpha. inhibitor is a human TNF.alpha. antibody, or antigen-binding portion thereof. 16. The shroud deployment assembly of claim 15, wherein the human TNF.alpha. antibody, or antigen-binding portion thereof, is adalimumab or golimumab. 17. An automatic injection device, comprising: a housing having an internal bore extending between a proximal end and a distal end; a shroud disposed within the internal bore at the proximal end of the housing of the automatic injection device, the shroud movable between a retracted position and an extended position relative to the housing, the shroud comprising: a tubular member extending between a proximal end and a distal end, and one or more arms extending from the distal end of the tubular member; and a syringe carrier disposed partly within the tubular member of the shroud, the syringe carrier comprising a tubular member having a slot forming a trench in an outer surface thereof extending along a length of the syringe carrier; wherein, as the shroud is deployed from the retracted position to the extended position, the one or more arms of the shroud move forwardly within a constrained space formed between an inner surface of the housing of the automatic injection device and an outer surface of the tubular member of the syringe carrier to engage with the trench; and wherein the trench is configured to facilitate movement of the one or more arms of the shroud within the constrained space during deployment of the shroud. 18. The automatic injection device of claim 17, wherein the height of the constrained space is configured to be at least equal to a thickness of the one or more arms of the shroud. 19. The automatic injection device of claim 17, wherein an outer diameter of the tubular member of the syringe carrier is configured to range from about 13.0 mm to about 14.0 mm. 20. The automatic injection device of claim 17, wherein a thickness of the one or more arms of the shroud is configured to reduce the pinching effect of the one or more arms during its movement in the constrained space. 21. The automatic injection device of claim 20, wherein the thickness of the one or more arms of the shroud is configured to be at most equal to the height of the constrained space. 22. The automatic injection device of claim 21, wherein the thickness of the one or more arms of the shroud is configured to range from about 1.3 mm to about 1.4 mm. 23. The automatic injection device of claim 17, wherein an inner diameter of the housing of the automatic injection device is configured to range from about 17 mm to about 18 mm. 24. The automatic injection device of claim 17, wherein the tubular member of the syringe carrier comprises: a proximal tubular portion having a first diameter; a distal tubular portion having a second diameter less than the first diameter; and a chamfered relief formed between the proximal and distal tubular portions. 25. The automatic injection device of claim 24, wherein the chamfered relief has an angle ranging from about 5 degrees to about 60 degrees. 26. The automatic injection device of claim 17, wherein the trench has a depth ranging from about 0.1 mm to about 0.5 mm. 27. The automatic injection device of claim 17, wherein the shroud, in the extended position, protectively sheathes a needle disposed at a proximal end of the automatic injection device, and wherein the shroud, in the retracted position, exposes a needle disposed at a proximal end of the automatic injection device. 28. The automatic injection device of claim 17, wherein, once the shroud is deployed to the extended position, the shroud is configured to withstand a force of at least 80 N without retracting to the retracted position. 29. The automatic injection device of claim 17, further comprising: a biasing mechanism that is compressed when the shroud is at the retracted position and that automatically biases the shroud from the retracted position to the extended position after the automatic injection device is removed from an injection site. 30. The automatic injection device of claim 17, wherein the automatic injection device comprises a dose of a TNF.alpha. inhibitor. 31. The automatic injection device of claim 30, wherein the TNF.alpha. inhibitor is a human TNF.alpha. antibody, or antigen-binding portion thereof. 32. The automatic injection device of claim 31, wherein the human TNF.alpha. antibody, or antigen-binding portion thereof, is adalimumab or golimumab. 33. A method for forming an automatic injection device, the method comprising: providing a housing having an internal bore extending between a proximal end and a distal end; disposing a shroud within the internal bore at the proximal end of the housing of the automatic injection device, the shroud movable between a retracted position and an extended position relative to the housing, the shroud comprising: a tubular member extending between a proximal end and a distal end, and one or more arms extending from the distal end of the tubular member; disposing a syringe carrier partly within the tubular member of the shroud, the syringe carrier comprising a tubular member having a slot forming a trench in an outer surface thereof extending along a length of the syringe carrier to configure a constrained space formed between the housing of the automatic injection device and the tubular member of the syringe carrier to minimize a pinching effect of the one or more arms of the shroud during its movement in the constrained space when moving from the retracted position to the extended position. 34. The method of claim 33, wherein the trench has a depth ranging from about 0.1 mm to about 0.5 mm. 35. The method of claim 33, wherein: the internal bore of the housing comprises a flange having at least one opening; as the shroud is deployed from the retracted position to the extended position, the one or more arms of the shroud move forwardly through the opening in the flange of the housing; and the flange is configured to minimize engagement of the one or more arms of the shroud with an edge of the flange to facilitate movement of the one or more arms of the shroud through the opening of the flange during deployment of the shroud. 36. The method of claim 35, further comprising: modifying the flange to increase the width of the opening of the flange. 37. The method of claim 36, further comprising: removing a portion of the flange abutting the opening of the flange, the length of the removed portion ranging from 0.05 mm to 0.6 mm. 38. A method for using an automatic injection device to deliver an injection, the method comprising: providing a shroud having one or more arms within a housing of the automatic injection device, the shroud being in a retracted position relative to the housing to expose a needle through an open proximal end of the shroud; delivering an injection using the automatic injection device through the needle; and deploying the shroud from the retracted position to an extended position relative to the housing of the automatic injection device to protectively sheath the needle after the injection, the one or more arms of the shroud moving forwardly within a constrained space formed between an inner portion of the housing of the automatic injection device and an outer portion of a tubular member of a syringe carrier wherein the constrained space and/or the one or more arms of the shroud are configured to minimize a pinching effect of the one or more arms during its movement in the constrained space; and wherein the outer portion of the tubular member of the syringe carrier comprises a slot forming a trench in an outer surface thereof extending along a length of the syringe carrier that increases the constrained space. 39. The method of claim 38, wherein the trench has a depth ranging from about 0.1 mm to about 0.5 mm. 40. The method of claim 38, wherein: an internal bore of the housing comprises a flange having at least one opening; as the shroud is deployed from the retracted position to the extended position, the one or more arms of the shroud move forwardly through the opening in the flange of the housing; and the flange is configured to minimize engagement of the one or more arms of the shroud with an edge of the flange to facilitate movement of the one or more arms of the shroud through the opening of the flange during deployment of the shroud. 41. The method of claim 40, wherein the flange is configured to increase the width of the opening of the flange. 42. The method of claim 41, wherein a portion of the flange abutting the opening is removed, the length of the removed portion ranging from 0.05 mm to 0.6 mm.

Details for Patent 9,956,353

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2030-04-29
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2030-04-29
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2030-04-29
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2030-04-29