Source: http://www.google.com/patents/US7976514?ie=ISO-8859-1
Timestamp: 2015-04-01 10:39:13
Document Index: 376310140

Matched Legal Cases: ['art 41', 'art 42', 'art 61', 'art 61', 'art 71', 'art 71']

Patent US7976514 - Automatic injection device with temporizing means - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsThe present invention relates to an injection device (1) comprising:�a container (5) receiving a product, and provided with an injection needle (6),�a housing (9, 11) receiving said container, said container being movable relative to said housing between an initial position, an insertion position,...http://www.google.com/patents/US7976514?utm_source=gb-gplus-sharePatent US7976514 - Automatic injection device with temporizing meansAdvanced Patent SearchPublication numberUS7976514 B2Publication typeGrantApplication numberUS 12/440,145PCT numberPCT/IB2007/003451Publication dateJul 12, 2011Filing dateSep 5, 2007Priority dateSep 6, 2006Also published asEP2076299A2, US8435215, US20100094214, US20110275992, US20130237913, WO2008029280A2, WO2008029280A3Publication number12440145, 440145, PCT/2007/3451, PCT/IB/2007/003451, PCT/IB/2007/03451, PCT/IB/7/003451, PCT/IB/7/03451, PCT/IB2007/003451, PCT/IB2007/03451, PCT/IB2007003451, PCT/IB200703451, PCT/IB7/003451, PCT/IB7/03451, PCT/IB7003451, PCT/IB703451, US 7976514 B2, US 7976514B2, US-B2-7976514, US7976514 B2, US7976514B2InventorsHerve Abry, Franck Carrel, Guillaume Grunhut, Lionel Maritan, Frederic PerotOriginal AssigneeBecton, Dickinson And CompanyExport CitationBiBTeX, EndNote, RefManPatent Citations (10), Referenced by (5), Classifications (35), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetAutomatic injection device with temporizing means
US 7976514 B2Abstract
The present invention relates to an injection device (1) comprising:�a container (5) receiving a product, and provided with an injection needle (6),�a housing (9, 11) receiving said container, said container being movable relative to said housing between an initial position, an insertion position, and a final position,�retaining means (12, 15), for maintaining said container in said insertion position,�deactivating means (20), for releasing said retaining means, said device being characterized in that it comprises:�temporizing means (19, 26, 27), for controlling the release of said retaining means until substantially all of the product contained within said container has passed through said injection needle before said container moves to said final position, and�a needle shield (2) coupled with said housing (9, 11) removal of said needle shield being with limited or no rotation of said needle shield. The invention also concerns a kit comprising such a device.
1. A device (1) for automatic injection of a product (3) into an injection site (4), the injection device comprising:
a container (5) having an open proximal end and a substantially closed distal end and being intended to receive the product, and provided at its distal end (5 a) with an injection needle (6) providing an outlet port of said container,
a housing (9, 11; 68; 72; 93) intended to receive, at least partially, said container, said container being movable relative to said housing between an initial position, in which said needle is contained within said housing, an insertion position, distally spaced relative to said initial position and in which said needle is exposed over a predetermined length, and a final position in which said needle is contained within said housing (9, 11; 68; 72),
retaining means (12, 15; 46, 47; 104, 105, 107), arranged to maintain said container in said insertion position,
deactivating means (20; 49; 99), arranged to release automatically said retaining means and cause said container to move to said final position,
temporizing means (19, 26, 27; 41, 43; 50; 51; 52; 53; 55, 56; 57, 58; 59, 63; 79, 75, 76; 96, 97, 98), arranged to control the release of said retaining means by said deactivating means until substantially all of the product contained within said container has been caused to pass through said outlet port and said injection needle before said container moves to said final position, said device being characterized in that it further comprises:
a needle shield (2) coupled with said housing (9, 11; 93) and covering the needle prior to use of said device,
and, in that before use, said housing (9, 11; 93) is coupled to a deshielder (2 a) comprising a cap (90) to which is fixed said needle shield (2), said housing comprising grooves (95) for guiding the translation of said cap (90) in an axial direction without rotation of said cap when said cap (90) is removed together with the removal of said deshielder (2 a) in view of using said device (1).
2. Device (1) according to claim 1, characterized in that said temporizing means comprises a chamber (26; 59; 79; 96) comprising a vent outlet (19; 63; 75, 76; 97, 98), said chamber being tightly closed by a sealing cover (27; 29 a; 60; 75, 76; 97, 98) in an initial state, and defining an initial volume of said chamber and in which a determined amount of fluid is contained within said initial volume, said sealing cover being movable within said chamber from said initial state to a final state in which at least part of said fluid has escaped through said vent outlet.
3. Device (1) according to claim 2, characterized in that said device further comprises elastic return means (24, 87) coupled to said chamber (26; 79; 96) for moving said sealing cover (27; 76; 98) from said initial state to said final state, said deactivating means (20; 99) being coupled to said chamber (29; 96) so that said deactivating means releases said retaining means (12, 15; 104, 105, 107) only when said sealing cover (27; 76; 98) is in said final state.
4. Device (1) according to claim 2, characterized in that said chamber (26, 29) comprises the proximal part of a sleeve (16; 30) having a closed proximal end (17; 30 a) and an open distal end (18; 30 b), said closed proximal end comprising a vent outlet and said open distal end comprising an outer radial rim (20), said device further comprising a piston (7) provided in said container and movable with respect to said container, and a plunger rod (8; 40) coupled to said piston so as to cause said piston to move with respect to said container, the movement of said piston causing said product to be expelled from said container through said injection needle, �said sealing cover (27; 29 a), in its initial state, closing the inner proximal space of said sleeve thereby defining said chamber, said sealing cover being coupled to said plunger rod, �said outer radial rim (20) being able to cooperate with and release said retaining means when said sealing cover comes into contact with said closed proximal end of said sleeve.
5. Device (1) according to claim 4, characterized in that it further comprises first elastic return means (24) coupled to said housing (9, 11) for moving said container from said initial position to said insertion position, second elastic return means (25) coupled to said housing for moving said container from said insertion position to said final position, and a ring (14), said ring being coupled to said container at least from said insertion position to said final position of said container,
said retaining means comprises a flexible tongue (12) provided on said housing and engaged on an abutment surface (15 a) situated on said ring, when said container is in said insertion position,
6. Device (1) according to claim 5, characterized in that it further comprises first retaining means (10, 20; 31, 32), arranged to maintain said container in said initial position, and first deactivating means (22, 23; 30), arranged to release said first retaining means and cause the insertion of said needle at the injection site (4), wherein said first retaining means comprises a flexible tooth (10) provided on said housing, said flexible tooth being engaged with said outer radial rim (20) of said sleeve when said container is in said initial position,
said first deactivating means comprises a push button (22) comprising at least one distal leg (23),
7. Device (1) according to claim 1, characterized in that it further comprises first retaining means (10, 20; 31, 32) arranged to maintain said container in said initial position, and first deactivating means (22, 23; 30) arranged to release said first retaining means and cause the insertion of said needle at the injection site (4), wherein said first deactivating means (22, 23; 30) are manually actuated.
8. Device according to claim 1, characterized in that said device further comprises means for indicating to a user that substantially all of the product contained within said container has been caused to pass through said outlet port and said injection needle.
9. Device according to claim 1, characterized in that said device further comprises tamper-evidence means (2, 2 a) removably coupled with said housing to shield said needle prior to use of said device, said tamper-evidence means being in one of a pre-use condition and a post-use condition, said post- use condition preventing re-use of said tamper evidence means with said device.
10. Device according to claim 9, wherein said post-use condition provides a visual indication that said tamper evidence means has been removed from said device.
11. Device according to claim 9, wherein said tamper-evidence means comprises said deshielder (2 a) and said needle shield (2), said post-use condition proving an indication that said tamper-evidence means has been removed from said device.
12. Device (1) according to claim 2, characterized in that:
said device further comprising a piston (7) provided in said container (5) and movable within said container, the distal movement of said piston causing said product to be expelled from said container through said injection needle (6),
said chamber (59) being partly defined by the inner part (61) of the container (5) situated proximally to said piston and partly defined by the proximal part of said housing (68), said sealing cover (60) joining the proximal end (5 b) of said inner part (61) to said housing (68) through a friction force of absolute value F,
said chamber being filled in said initial state of said sealing cover with a pressurized fluid (64) exerting a pressure of absolute value Pc on said container in the distal direction, with the intermediary of the piston (7),
said device further comprising elastic return means (62) for moving said container (5) from the insertion position to the final position, said elastic return means being coupled to said container so as to exert on said container a return force of absolute value Pe when said elastic return means is at least in a partly compressed state,
wherein Pc decreases as part of the pressurized fluid (64) is escaping the chamber via the vent outlet (63), said retaining means are formed by Pc being greater than (Pe+F), said retaining means being released when Pe becomes equal or greater than (Pc+F).
13. Device (1) according to claim 12, wherein said pressurized fluid (64) is provided to said chamber (59) from a recipient (65) present within said chamber (59), said recipient being sealingly closed when said container is in its initial position, said device being provided with a puncturing button (66) capable of creating an opening (67) in said recipient when a manual force is exerted on said puncturing button, said pressurized fluid being then allowed to escape from said recipient and to fill said chamber.
14. Device (1) according to claim 2, wherein said sealing cover (75, 76; 97, 98) is porous and forms said vent outlet.
15. Device (1) according to claim 14, wherein said device further comprises:
a piston (7) provided in said container (5) and movable within said container, the distal movement of said piston causing said product to be expelled from said container through said injection needle (6),
a piston rod (74) provided with a head (73) and a distal end (77), said piston rod (74) being independent from said piston (7), said chamber (79; 96) is defined by the volume delimited by the inner part (71) of the container (5) situated proximally to said piston, the wall of the housing (72) and the head (73) of the piston rod, the proximal end (5 b) of said container (5) joining the wall of the housing via a first porous sealing cover (75; 97) and the head (73) of the piston rod (74) joining the wall of the housing via a second porous sealing cover (76; 98).
16. Device (1) according to claim 15, wherein:
the two sealing covers (75, 76) present a friction force against the wall of said housing (72) of absolute value F,
said chamber (79) is filled in the initial state of said second sealing cover (76) with a pressurized fluid (88) exerting a pressure of absolute value Pc on said container (5) in the distal direction, with the intermediary of the piston (7),
said device further comprising first elastic return means (87) for moving said container (5) from the initial position to the insertion position, said first elastic return means being coupled to said piston rod (74) so as to exert on said piston rod (74) a return force of absolute value Pi when said first elastic return means is at least in a partly compressed state,
said device further comprising second elastic return means (81) for moving said container (5) from the insertion position to the final position, said second elastic return means being coupled to said container so as to exert on said container a return force of absolute value Pe when said second elastic return means is at least in a partly compressed state, wherein (Pc+Pi) is greater than (Pe+F) in the initial sate of said second sealing cover (76), wherein Pc decreases as part of the pressurized fluid (88) is escaping the chamber (79) via the vent outlet (75, 76), said retaining means are formed by (Pc+Pi) being greater than (Pe+F), said retaining means being released when Pe becomes equal or greater than (Pc+F+Pi).
17. Device (1) according to claim 15, wherein the deactivating means comprise a valve (99) situated on said first porous sealing cover (97), said valve being closed when said second porous sealing cover (98) is in its initial state and opened when said second porous sealing cover is in its final state, the opening of said valve (99) releasing part of said retaining means (104, 105, 107).
EP 1 586 341and EP 1 586 342disclose injection devices provided with damping means for controlling the rate of the injection.
The device of the invention allows the injection of the totality of the product before the needle is retracted. Thanks to the temporizing means of the device of the invention, the retraction of the needle is not triggered when some product is still present at the bottom of the container of the injection device. Some time, for instance between 1to 10seconds, is allowed before the retraction of the needle is triggered.
Said vent outlet may be a simple hole, with a small diameter. For instance said diameter may range from 15micrometer to 25micrometer. Alternatively, said vent outlet may be an exhaust valve comprising a membrane allowing the passage of the fluid. Said membrane may be made of a material selected from the group comprising polytetrafluoroethylene, polyethylene, paper, tissue, foam, porous plastic, and combinations thereof. The diameter of said membrane may be about 1mm.
wherein (Pc+Pi) is greater than (Pe+F) in the initial sate of said second sealing cover,
an upper housing assembly, a lower housing assembly, at least one of said upper and said lower housing assembly being adapted to receive part of the container, the container being movable, when received within said at least one of said upper and said lower housing assembly, between an initial position, in which a tip of said needle does not extend beyond a distal end of said lower housing assembly, an insertion position, distally spaced relative to said initial position and in which the tip of the needle extends beyond said distal end of said lower housing assembly, and a final position in which said needle is contained within one of said upper and said lower housing assembly, and means for connecting said upper housing and said lower housing together. Preferably, said kit further comprises means for carrying at least one of said upper housing assembly and said lower housing assembly, said carrying means carrying said one of said upper housing assembly and said lower housing assembly in a predetermined orientation.
FIG. 17 ais a front view of the distal end of the proximal part of a plunger rod suitable for forming part of the temporizing means of the device of the invention,
FIG. 17 bis a side view of the distal end of the proximal part of the plunger rod of FIG. 17 a, FIG. 17 cis a cross section view in perspective of the distal part of the plunger rod of FIG. 17 a,
In reference to FIGS. 1 and 2, the injection device comprises a container 5 which is intended to receive a product 3 that is to be injected. The container 5 has a distal end 5 aand an open proximal end, which is provided, on the example shown, with a flange 5 b. Said flange 5 bmay be useful for grasping said container 5. The distal end 5 aof the container 5 is substantially closed and is provided with an injection needle 6. This injection needle 6 provides an outlet port of said container 5 for the product 3. On FIGS. 1 and 2, the distal end of said container 5 is also provided with a needle shield 2 that covers and protects the needle 6 before use of the device 1. The needle shield 2 also provides for a sealing means of the distal end of the container 5 before use.
The device 1 of FIGS. 1 and 2 also comprises a piston 7 which is provided in the container 5 and which is movable with respect with said container 5. A plunger rod 8 is coupled to, said piston 7 so as to cause said piston to move with respect to said container 5, the movement of said piston 7 being intended to cause said product 3 to be expelled from said container 5 through the injection needle 6 during the injection step and thus realize injection, as will be seen on FIGS. 4 to 6. As used herein, the term �coupled� refers to any permanent or temporary connection between two parts. For example, by way of illustration and not limitation, two parts may be coupled together using a screw-type connection, by mere contact with each other, or with adhesive. Other types and ways of connecting two parts will be obvious to a person skilled in the art and from the disclosure provided herein.
The container 5 is received within a support 21 having a global tubular shape: said support 21 is open at both ends. Said support 21 is provided at its proximal end with at least two claws 21 ain which the flange 5 b of the container 5 is fixed.
The device 1 of FIGS. 1 and 2 further comprises a housing (9, 11) intended to receive the container 5. In the example shown, said housing has a global tubular shape and is made of two cylinders, a proximal cylinder 9 and a distal cylinder 11 which, as shown on FIG. 2, are snapped to each other when the device is in use. In an embodiment of the invention not shown, the housing (9, 11) could be made of a single piece. The needle shield 2 is coupled to the housing (9, 11) and covers the needle 6 prior to use of the device 1. In particular, as appears clearly from FIG. 2, the device 1 is provided with a deshielder 2 ato which is fixed the needle shield 2. Such a deshielder 2 ais shown in greater details on FIGS. 26 and 27. The housing (9, 11) of the device 1 is coupled to the deshielder 2 awhich comprises a cap 90 to which is fixed the needle shield 2. As shown on FIG. 27, the housing comprises grooves 95 for guiding the translation of said cap 90 when the cap 90 is removed together with the removal of said deshielder 2 ain view of using said device 1. In consequence, when the user removes the deshielder 2 ain order to use the device 1, the cap 90 follows the grooves 95 and it does not rotate. The needle shield 2, which is fixed to the cap 90, neither rotates. The rotation of the tip of the needle 6 within the rubber forming the needle shield is therefore avoided and the core that could result from such a potential rotation is also avoided. The integrity and sterility of the needle 6 are therefore preserved and the administration do the product can be completed safely.
As shown on FIG. 2, the distal cylinder 11 of the housing is provided in its distal part with at least two flexible tongues 12 which are capable of being deflected radially and outwardly. The distal end of said distal cylinder 11 is provided with an inner ridge 13: the distal face 13 aof said inner ridge forms a bearing surface for the device 1 on the injection site 4 (see FIG. 4).
The device 1 of FIGS. 1 and 2 further comprises a sleeve 16 having a closed proximal end 17 and an open distal end 18. Said sleeve 16 is intended to receive at least partially said support 21. The proximal end 17 of the sleeve 16 comprises a vent outlet 19. The vent outlet 19 may be a little hole. For instance, the diameter of said hole may range from 15micrometer to 25micrometer. Alternatively, the hole is replaced by a membrane vent. In such a case, the diameter of said membrane may be about 1mm. The distal end 18 of said sleeve 16 is provided with an outer radial rim 20.
The device 1 of FIGS. 1 and 2 further comprises a sealing cover 27 which is intended to be coupled to the head 8 aof the plunger rod 8.
The device 1 of FIGS. 1 and 2 also comprises a ring 14 which is intended to receive the distal part of said support 21 and to be coupled to said container 5 at least from the insertion position to the final position of said container 5. The ring 14 has a proximal part and a distal part, the diameter of said proximal part being less than the diameter of said distal part, said proximal and distal parts being joined by a radial wail 15. The radial wall 15 has a proximal face 15 aand a distal face 15 b. The device 1 of FIGS. 1 and 2 further comprises a push button 22 intended to be lodged between the proximal cylinder 9 of said housing and said sleeve 16. The push button 22 has the global shape of a cylinder closed at its proximal end: the proximal end of the push button 22 forms a pushing surface 22 afor the user to exert a manual pressure in view of triggering of the device 1. The inner wall of the proximal part of the push button 22 is provided with an inner rim 22 b. The push button 22 is further provided at its distal end with at least two distal legs 23.
In the device 1 according to FIGS. 1 and 2, a first helicoidal spring 24 is provided between the push button 22 and the sleeve 16. As appears from FIG. 2, the distal end of the first helicoidal spring bears on the proximal face of said outer radial rim 20 of said sleeve 16, and the proximal end of the first helicoidal spring bears on the distal face of the inner rim 22 bof the push button 22. A second helicoidal spring 25 is provided between said support 21 and said ring 14: as shown on FIG. 2, the distal end of the second helicoidal spring 25 bears on the proximal face 13 bof the inner ridge 13 of the distal cylinder 11 and the proximal end of said second helicoidal spring 25 bears on the distal face 15 bof said radial wall 15 of said ring 14.
The device 1 of FIGS. 1 and 2 is finally provided with a deshielder 2 afor removing the needle shield 2 when the user decides to realize the injection. As will be seen later, the deshielder 2 aand the needle shield 2 are removably coupled with the housing (9, 11) and they act as tamper-evidence means to shield the needle 6 prior to use of the device 1, said tamper-evidence means being able to adopt a pre-use condition and a post-use condition, said post-use condition preventing re-use of the tamper-evidence means with the device 1.
In this position, the needle 6 is protected by the needle shield 2 which is coupled the deshielder 2 a. Accordingly, the deshielder 2 aand the needle shield 2 form the tamper-evidence means which is in its pre-use condition.
When the user decides to realize the injection, he first removes the deshielder 2 a:by this operation, he also removes the needle shield 2. The tamper-evidence means, formed by the deshielder 2 aand the needle shield 2 is therefore in its post-use condition. The removal of the needle shield 2 is completed with limited or no rotation of the needle shield 2. Potential coring caused by the tip of the needle 6 rotating in the rubber forming the needle shield 2 is therefore prevented.
In a step not shown, the user then applies the device 1 on the injection site 4 by means of the bearing surface 13 aof said distal cylinder 11. He then manually actuates the push button 22 by exerting on the pushing surface 22 aa distal force so as to cause said push button 22 to move distally.
As shown on FIG. 3, during this movement, the distal legs 23 come in contact with said flexible teeth 10, causing said flexible teeth 10 to deflect radially and outwardly. By way of consequence, said flexible teeth 10 are disengaged from said outer radial rim 20 in which they were previously engaged. The first helicoidal spring 24 is therefore free to return to a normal state and it extends distally, drawing with him the sleeve 16. The sleeve 16 being coupled to said plunger rod 8 by means of the sealing cover 27 which is fixed onto the head 8 aof the plunger rod 8, the plunger rod 8 is drawn distally by the sleeve 16. Moreover, the distal end of the plunger rod 8 being threaded within the piston 7, the plunger rod 8 is coupled to said container 5, at least from the initial position to the insertion position of the container, by means of the friction force exerted by the outer walls of said piston 7 onto the inner walls of said container 5. In consequence, the container 5 is also drawn distally causing the needle 6 to penetrate the injection site 4 until the distal end of said support 21 abuts on the proximal face 13 bof the inner ridge 13 of said distal cylinder 11, as shown on FIG. 4.
Once the piston 7 is proximate to said distal end 5 aof the container 5 and abuts more or less on said distal end 5 athe force of said first helicoidal spring 24 overcomes the friction force of the sealing cover 27 against the inner walls of said sleeve 16 and said sleeve continues to move distally, causing part of the pressurized fluid present in said chamber 26 to escape via the vent outlet 19, as shown on FIG. 5.
As shown on FIG. 5, in the device 1 of the invention, although the piston 7 has reached the distal end of the container 5, said container 5 is prevented from moving from its insertion position to its final position, as long as substantially all the product has not been expelled, and especially as long as said sealing cover 27 has not reached its final state (see FIG. 6): indeed, as clearly appears from FIG. 5, the second helicoidal spring 25, which is intended to move said container from its insertion position to its final position, is still prevented from extended proximally by means of engagement of said flexible tongues 12 on the abutment surface 15 a. The time for the sealing cover 27 to move from its initial state to its final state allows the totality of the liquid to be expelled through the injection needle 6.
As shown on FIG. 6, the sleeve 16 continues to move distally, under the force exerted by said first helicoidal spring 24, until the sealing cover 27 comes in contact with the proximal end of said sleeve 16 and substantially all the pressurized fluid present in the chamber 26 has escaped via the vent outlet 19. During this movement, the outer radial rim 20 comes in contact with said flexible tongues 12 which are then caused to deflect radially and outwardly, as shown on FIG. 6. The radial wall 15 is therefore disengaged from said flexible tongues 12 and the second helicoidal spring 25 is free to move proximally. The force of said second helicoidal spring 25 being greater than the force of the first helicoidal spring 24, said second helicoidal spring 25 pushes said ring 14, which is coupled to said support 21 in the proximal direction, thanks to an outer rim 21 cprovided on said support 21 on which the proximal end 14 aof said ring abuts.
As can be seen from FIG. 8, the deactivating means and the chamber are provided as a sleeve 30 which is closed at its proximal end. Said proximal end forms a pushing surface 30 afor the user to exert a manual and distal pressure when he wishes to activate the device 1. The proximal end comprises a vent outlet 29 b. A sealing cover 29 ais provided on the head of a plunger rod 8.
In steps not shown, after removal of the needle shield and the deshielder, the user applies the device 1 on the injection site and he pushes distally on pushing surface 30 acausing said sleeve 30 to move distally. The manual pressure exerted on the sleeve 30 by the user overcomes said stop 32 and the first helicoidal spring 24 is then free to move distally. The first helicoidal spring 24 pushes on the outer radial rim 20 of said sleeve 30, thereby realising the insertion of the needle 6, the injection and the temporization as seen for the device 1 of FIGS. 1 to 7. The container 5 is caused to move from its insertion position to its final position by the second helicoidal spring 25 only when the sealing cover 29 ahas reached its final state by coming in contact with the proximal end of said sleeve 30.
On FIGS. 12 to 17 care shown alternative temporizing means in the form of a plunger rod 40 provided in two parts, a proximal part 41 and a distal part 42. The references pertaining to the same elements as in FIGS. 9 to 11 have been retained.
On FIGS. 17 ato 17 cis shown a plunger rod for which said cylinder walls are provided with a number of steps 57 and the distal end of said proximal part of said plunger rod is provided with a number of radial flaps 58, the number of radial flaps that interact with said steps increasing as said proximal part of said plunger rod moves distally.
The device 1 of FIGS. 18-21 comprises a chamber 59 partly defined by the inner part 61 of the container situated proximally to the piston 7. The rest of the chamber 59 is defined by the walls of the housing 68 receiving the container 5. A sealing cover 60 joins the proximal end 5 bof said inner part 61 to the housing 68 through a friction force of absolute value F. At its proximal end, the chamber 59 comprises a vent outlet 63. The chamber 59 also comprises a recipient 65, preferably made of rigid walls.
In this position, the needle 6 is protected by a needle shield 2 and a deshielder 2 a. The recipient 65 is filled with the pressurized fluid 64. When the user desires to proceed with the administration of the product 3, he removes the deshielder 2 aand the needle shield 2, applies the device 1 on the injection site 4 and exerts a manual force on the puncturing button 66. The puncturing button 66 penetrates a wall of the recipient 65 and creates an opening 67 as shown on FIG. 19.
The pressurized fluid 64 is then allowed to escape the recipient 65 via the opening 67 and begins to fill the chamber 59. As shown on FIG. 19, as the pressurized fluid 64 spreads into the chamber 59, it pushes an the sealing cover 60 and therefore on the container 5 which is caused to move distally. By way of consequence, the needle 6 penetrates the injection site and the device 1 is in the insertion position. Once the distal movement of the container 5 is stopped, thanks to the proximal end 5 bof said container 5 bearing on the distal end of the sleeve 69, the pressure exerted by the pressurized fluid 64 in the chamber 59 causes the piston 7 to move distally.
A first sealing cover 75 joins the proximal end 5 bof said inner part 71 to the housing 72. A second sealing cover 76 joins the head 73 of the piston rod 74 to the housing 72 and therefore seals the chamber 79. The two sealing covers (75, 76) are porous sealing cover. In consequence, they both form an outlet vent for any pressurized fluid comprised in the chamber 79. The two sealing covers (75, 76) present altogether a friction force against the wall of the housing 72 of absolute value F.
When the user desires to proceed with the administration of the product 3, he removes the deshielder 2 aand the needle shield 2, applies the device 1 on the injection site 4 and exerts a manual force on the pushing button 83. The push button 83 therefore moves distally and its distal legs 84 come in contact with the flexible tongues 85 of the housing 72. Under the pressure of the distal legs 84, the flexible tongues 85 deflect radially and become disengaged from the abutment surfaces 86. The spring 87 is then free to return to its expanded state and it pushes the piston rod 74 in the distal direction. The friction F of the sealing covers (75, 76) being less than the friction force of the piston 7 against the inner wall of the container 5, said container 5 is drawn in the distal direction, thereby realising the insertion of the needle 6 in the injection site 4, as shown on FIG. 23.
Once the distal movement of the container 5 is stopped, thanks to the proximal end 5 bof said container 5 bearing on the distal end of the sleeve 78, the force of the spring 87 overcomes the stiction force and the piston 7 is pushed distally by the distal end of the piston rod 74, therefore realising the injection of the product 3 into the injection site 4.
In reference to FIGS. 26 and 27 there is shown partial views of a deshielder 2 asuitable as a tamper-evidence means for a device of the invention. The deshielder 2 ais made of a cap 90 and a ring 91 connected to each other by breakable bridges 92.
In the pre-use condition, as shown on FIG. 26, the deshielder 2 a is fixed on the housing 93 of a device according to the invention. The cap 90 and the ring 91 are made of a single piece, for example by moulding injection, and are connected to each other by means of the breakable bridges 92 The housing 93 is provided with stops 94 that prevent a user from breaking the bridges 92 by applying a proximal force on the cap 90.
When a user is ready to use the device of the invention, he removes the deshielder 2 aby pulling distally on the cap 90 so as to remove it from the housing 93, thereby breaking the breakable bridges 92.
On FIG. 27, the tamper-evidence means formed by the deshielder 2 ais in its post-use condition. Any user, provided with the device with the deshielder 2 ain this condition can immediately notice, thanks to the broken bridges 92, that the device has been tampered. The post-use condition of the deshielder proves an indication that the tamper-evidence means has been removed from the device.
On FIG. 28 is shown a tray 400 for carrying upper housing assemblies 100 in a predetermined direction. The carrying means 400 of FIG. 28 can especially carry a plurality of upper housings 100, all disposed in the same direction. Such a tray comprises a plurality of holes 402 intended to receive the upper housing assemblies 100. Such a tray 400 is useful for transporting and/or handling upper housings of a device of the invention during all the various steps of manufacturing, filling, packaging, etc . . .
A first sealing cover 97 joins the proximal end 5 bof said inner part 71 to the housing 72. A second sealing cover 98 joins the head 73 of the piston rod 74 to the housing 72 and therefore seals the chamber 96. The two sealing covers (97, 98) are porous sealing cover. In consequence, they both form an outlet vent for any pressurized fluid comprised in the chamber 96. The two sealing covers (97, 98) present altogether a friction force against the wall of the housing 72 of absolute value F.
The device 1 of FIGS. 30-33 comprises a sleeve 102 received within said housing 72 and receiving said container 5. The sleeve 102 comprises in its distal area an inner radial rim 103 and at its proximal end a flexible tongue 104 provided with an abutment surface 105. A helical spring 106 is placed between said container 5 and said sleeve 102, the proximal end of said spring 106 bearing on the distal face of said abutment surface 105 by the intermediary of a ring 107 and the distal end of said spring 106 bearing on the proximal face of said inner radial rim 103 of said sleeve 102.
When the user desires to proceed with the administration of the product 3, he removes the deshielder 2 aand the needle shield 2, applies the device 1 on the injection site 4 and exerts a manual force on the pushing button 83. The push button 83 therefore moves distally and its distal legs 84 come in contact with the flexible tongues 85 of the housing 72. Under the pressure of the distal legs 84, the flexible tongues 85 deflect radially and become disengaged from the abutment surfaces 86. The spring 87 is then free to return to its expanded state and it pushes the piston rod 74 in the distal direction. The friction F of the sealing covers (97, 98) being less than the friction force of the piston 7 against the inner wall of the container 5, said container 5 is drawn in the distal direction, thereby realising the insertion of the needle 6 in the injection site 4, as shown on FIG. 31.
Patent CitationsCited PatentFiling datePublication dateApplicantTitleUS20040024367Jul 31, 2003Feb 5, 2004Scott GilbertInjection device providing automatic needle retractionUS20090088688 *Mar 21, 2006Apr 2, 2009Barrow-Williams Timothy DonaldInjection deviceEP1586341A2May 7, 1999Oct 19, 2005Tecpharma Licensing AGDevice for the dosed application of an injectable productEP1586342A2May 7, 1999Oct 19, 2005Tecpharma Licensing AGDevice for administering an injectable productWO1995029720A1Apr 25, 1995Nov 9, 1995Pa Consulting ServicesSafety injection deviceWO2000024441A1Oct 25, 1999May 4, 2000Pharmacia & Upjohn AbAutoinjectorWO2003097133A1May 16, 2003Nov 27, 2003Owen Mumford LtdInjection device with automatically retractable needleWO2004054645A2Dec 17, 2003Jul 1, 2004Cilag Ag IntInjection deviceWO2005115512A1May 27, 2005Dec 8, 2005Cilag Ag IntInjection deviceWO2005115516A1May 27, 2005Dec 8, 2005Cilag Ag IntInjection device* Cited by examinerReferenced byCiting PatentFiling datePublication dateApplicantTitleUS8876783 *Nov 26, 2009Nov 4, 2014Shl Group AbMedicament delivery deviceUS8915886Oct 21, 2010Dec 23, 2014Owen Mumford LimitedAutoinjectorUS20110063825 *Sep 17, 2009Mar 17, 2011Chi-Wen ChengCupulate lightUS20110288492 *Nov 26, 2009Nov 24, 2011Shl Group AbMedicament Delivery DeviceUS20130046238 *Mar 9, 2011Feb 21, 2013Menarini International Operations Luxembourg S.A.Device for the automatic injection of two doses of a medicament* Cited by examinerClassifications U.S. Classification604/246, 604/192, 604/208, 604/263, 604/157, 604/228, 604/198, 604/187, 604/110, 604/135, 604/234, 604/218International ClassificationA61M5/00Cooperative ClassificationA61M5/2033, A61M5/5086, A61M5/2053, A61M5/24, A61M5/31525, A61M2005/2407, A61M5/31566, A61M5/326, A61M5/31511, A61M2005/2073, A61M5/3202, A61M2005/206, A61M2005/244, A61M5/008, A61M2005/3261, A61M2005/3143, A61M2205/192, A61M5/3204, A61M2005/3109, A61M5/20European ClassificationA61M5/20C, A61M5/32C2H2FLegal EventsDateCodeEventDescriptionNov 23, 2009ASAssignmentOwner name: BECTON DICKINSON FRANCE S.A.S.,FRANCEFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ABRY, HERVE;CARREL, FRANCK;GRUNHUT, GUILLAUME AND OTHERS;SIGNED BETWEEN 20091110 AND 20091117;US-ASSIGNMENT DATABASE UPDATED:20100415;REEL/FRAME:23557/35Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ABRY, HERVE;CARREL, FRANCK;GRUNHUT, GUILLAUME;AND OTHERS;SIGNING DATES FROM 20091110 TO 20091117;REEL/FRAME:023557/0035Owner name: BECTON DICKINSON FRANCE S.A.S., FRANCERotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services