Granted Patent B2

US 12,605,506 · App. 17/057,562 · Granted Apr 21, 2026

Inventors: Jacques Appy (Schlierbach, FR); Andrew Bryant (Buggingen, DE); Neil Cammish (Manchester, GB); Congyi Huang (Klagenfurt, AT); John Palmer-Felgate (Horsham, GB); Claudio Rossi (Elinsbach, CH); Oliver Shergold (Bolligen, CH); Gianluca Tordi (Derendingen, CH); Adrian Francios Von Muralt (Basel, CH); Mark Horlock (Cheshire, GB)

Assignee: Novartis AG

A61M5/2033A61M5/20A61M5/24A61M5/3202A61M5/3204A61M5/3234A61M2005/2013A61M2005/3267A61M2207/00

Abstract

Claims (55)

1 . An automatic drug delivery device for dispensing a fluid product, the automatic drug delivery device comprising:

(a) a longitudinal housing extending along a longitudinal axis and having a proximal end close to a dispensing site, a distal end opposite to the proximal end and a hollow interior;

(b) a removable cap mountable to the proximal end of the longitudinal housing;

(c) a syringe assembly arranged in a mounting position inside the longitudinal housing and having a hollow syringe body and an injection needle formed with the hollow syringe body including the fluid product; and

(d) a drive mechanism configured to be triggered by a trigger element in order to initiate dispensing of the fluid product;

wherein the drive mechanism is operatively coupled with a safety shield movable within the longitudinal housing;

wherein the safety shield is biased into a proximal position in which the safety shield protrudes out of the proximal end of the longitudinal housing in order to cover a needle tip of the injection needle, and wherein the safety shield is movable into a distal position in which the injection needle is exposed for injection;

wherein the syringe assembly is provided with a needle shield attachable to a proximal end of the hollow syringe body and covering the injection needle together with the needle tip;

wherein the removable cap includes a flexible gripping element for engaging the needle shield on an outer circumferential surface of the needle shield, such that removal of the removable cap results in removal of the needle shield, the flexible gripping element having a greater diameter than a proximal end of the safety shield, the flexible gripping element not extending into the safety shield; and

wherein the safety shield is configured to remain in a position in which at least a portion of the needle shield extends proximally beyond a proximal end of the safety shield, and in which at least a portion of the injection needle extends proximally beyond the proximal end of the safety shield, when the removable cap is mounted to the proximal end of the longitudinal housing.

2 . The automatic drug delivery device as claimed in claim 1 , wherein the flexible gripping element is fixedly mounted or arranged with axial and/or radial clearance within the removable cap so that the flexible gripping element is rotatable relative to the removable cap.

3 . The automatic drug delivery device as claimed in claim 1 , wherein the flexible gripping element is formed by a flexible washer having a mounting section to be mounted within the removable cap and at least one gripping arm projecting in a radial inward direction for engaging the needle shield.

4 . The automatic drug delivery device as claimed in claim 3 wherein the flexible gripping element provides an asymmetric force so that, once removed from the hollow syringe body, the needle shield is biased to a non-axial alignment.

5 . The automatic drug delivery device as claimed in claim 1 , wherein the flexible gripping element has a circular outer circumference surrounding a ring-shaped body, wherein the flexible gripping element includes at least two radially inwardly extending lobes integrally formed with the ring-shaped body and ending in a radially inner gripping surface or feature.

6 . The automatic drug delivery device as claimed in claim 5 , wherein the flexible gripping element has a flat shape or a frusto-conical shape, wherein the at least two radially inwardly extending lobes provide an axial spring action.

7 . The automatic drug delivery device as claimed in claim 1 , wherein the removable cap is retained on the proximal end of the longitudinal housing and wherein a movement of the removable cap relative to the longitudinal housing is supported by a biasing force applied to the safety shield.

8 . The automatic drug delivery device as claimed in claim 7 , wherein the removable cap is axially retained on the proximal end of the longitudinal housing by engagement of retaining elements between the removable cap and the longitudinal housing, the retaining elements being disengaged by rotation of the removable cap relative to the longitudinal housing to allow axial movement of the removable cap relative to the longitudinal housing to remove the removable cap, the axial movement of the removable cap relative to the longitudinal housing being supported by the biasing force applied to the safety shield.

9 . The automatic drug delivery device as claimed in claim 1 , wherein the removable cap includes at least one cam path surface, wherein the at least one cam path surface is adapted or inclined relative to the longitudinal axis for guiding the removable cap in a proximal direction along at least a portion of a rotation of the removable cap relative to the longitudinal housing.

10 . The automatic drug delivery device as claimed in claim 1 , wherein the flexible gripping element is configured to engage and/or restrain the needle shield on the outer circumferential surface; and wherein the needle shield is rigid.

11 . The automatic drug delivery device as claimed in claim 1 , wherein the flexible gripping element includes first and second lobes, wherein the first lobe has a first length, wherein the second lobe has a second length different from the first length.

12 . The automatic drug delivery device as claimed in claim 1 , wherein the removable cap includes an end cap body, wherein the flexible gripping element is fixedly secured to the end cap body.

13 . The automatic drug delivery device as claimed in claim 12 , wherein the flexible gripping element and the end cap body are formed as separate pieces.

14 . The automatic drug delivery device as claimed in claim 12 , wherein the removable cap includes a proximal end cap cover fixedly secured to the end cap body.

15 . The automatic drug delivery device as claimed in claim 14 , wherein the proximal end cap cover defines a closed proximal end of the removable cap.

16 . The automatic drug delivery device as claimed in claim 1 , wherein the safety shield is biased in a proximal direction by a shield spring, wherein the shield spring is disposed entirely distally of the injection needle.

17 . The automatic drug delivery device as claimed in claim 16 , wherein the shield spring is disposed entirely distally of the safety shield.

18 . A method of assembling the automatic drug delivery device as claimed in claim 1 , the method comprising:

(a) providing a power-pack subassembly, the syringe assembly and a syringe holder, and a proximal subassembly;

the proximal subassembly including the longitudinal housing and the removable cap mounted to the proximal end of the longitudinal housing wherein the proximal subassembly further comprises the safety shield;

the power-pack subassembly comprising the drive mechanism;

(b) mounting the syringe assembly in the syringe holder;

(c) inserting the syringe assembly and the syringe holder into the proximal subassembly such that the needle shield extends through the flexible gripping element so that the flexible gripping element engages the needle shield on the outer circumferential surface; and

(d) mounting the power-pack subassembly to the proximal subassembly such that the drive mechanism is operatively coupled with the safety shield.

19 . An automatic drug delivery device for dispensing a fluid product, the automatic drug delivery device comprising:

(a) a longitudinal housing extending along a longitudinal axis and having a proximal end close to a dispensing site, a distal end opposite to the proximal end and a hollow interior;

(b) a removable cap mountable directly to the proximal end of the longitudinal housing;

(c) a syringe assembly arranged in a mounting position inside the longitudinal housing and having a hollow syringe body and an injection needle formed with the hollow syringe body including the fluid product; and

(d) a drive mechanism configured to be triggered by a trigger element in order to initiate dispensing of the fluid product;

wherein the drive mechanism is operatively coupled with a safety shield movable within the longitudinal housing;

wherein the safety shield is biased into a proximal position in which the safety shield protrudes out of the proximal end of the longitudinal housing in order to cover a needle tip of the injection needle, and wherein the safety shield is movable into a distal position in which the injection needle is exposed for injection;

wherein the syringe assembly is provided with a needle shield attachable to a proximal end of the hollow syringe body and covering the injection needle together with the needle tip;

wherein the removable cap includes a flexible gripping element for engaging the needle shield on an outer circumferential surface of the needle shield, such that removal of the removable cap results in removal of the needle shield, the flexible gripping element having a greater diameter than a proximal end of the safety shield, the flexible gripping element not extending into the safety shield;

wherein the safety shield is configured to remain in a position in which at least a portion of the needle shield extends proximally beyond a proximal end of the safety shield when the removable cap is mounted to the proximal end of the longitudinal housing; and

wherein the safety shield is configured to apply a proximally-directed biasing force to the removable cap when the removable cap is mounted directly to the proximal end of the longitudinal housing.

20 . An automatic drug delivery device for dispensing a fluid product, the automatic drug delivery device comprising:

(a) a longitudinal housing extending along a longitudinal axis and having a proximal end close to a dispensing site, a distal end opposite to the proximal end and a hollow interior;

(b) a removable cap mountable to the proximal end of the longitudinal housing;

(c) a syringe assembly arranged in a mounting position inside the longitudinal housing and having a hollow syringe body and an injection needle formed with the hollow syringe body including the fluid product; and

(d) a drive mechanism configured to be triggered by a trigger element in order to initiate dispensing of the fluid product;

wherein the drive mechanism is operatively coupled with a safety shield movable within the longitudinal housing;

wherein the safety shield is biased into a proximal position in which the safety shield protrudes out of the proximal end of the longitudinal housing in order to cover a needle tip of the injection needle, and wherein the safety shield is movable into a distal position in which the injection needle is exposed for injection;

wherein the syringe assembly is provided with a needle shield attachable to a proximal end of the hollow syringe body and covering the injection needle together with the needle tip;

wherein the removable cap includes a flexible gripping element for engaging the needle shield on an outer circumferential surface of the needle shield, such that removal of the removable cap results in removal of the needle shield, the flexible gripping element having a greater diameter than a proximal end of the safety shield, the flexible gripping element not extending into the safety shield;

wherein the safety shield is configured to remain in a position in which at least a portion of the needle shield extends proximally beyond a proximal end of the safety shield when the removable cap is mounted to the proximal end of the longitudinal housing; and

wherein the removable cap has a closed proximal end, the needle shield being disposed entirely distally of the closed proximal end of the removable cap when the removable cap is mounted to the proximal end of the longitudinal housing.

Assignments (16)

Priority Claims (4)

Continuity (1)

References Cited (293)