SLEEVE FOR REINFORCING SYRINGE CARTRIDGE
20170259001 · 2017-09-14
Inventors
Cpc classification
A61M5/3007
HUMAN NECESSITIES
A61M5/24
HUMAN NECESSITIES
A61M5/30
HUMAN NECESSITIES
A61M2005/2477
HUMAN NECESSITIES
A61M2005/2418
HUMAN NECESSITIES
International classification
Abstract
An apparatus for transdermal injection includes a sleeve including a proximal end, a distal end, and an inner wall surface extending along the sleeve from a first opening at the proximal end to a second opening at the distal end. The inner wall surface forms a channel in the sleeve, the channel having a first portion with a substantially frustoconical shape. The channel of the sleeve is configured to receive a substantially frustconically shaped injection cartridge, to substantially uniformly support the injection cartridge during a transdermal injection operation, and to prevent movement of the injection cartridge out of the distal end of the sleeve.
Claims
1. An apparatus for transdermal injection, said apparatus comprising: a sleeve including a proximal end, a distal end, and an inner wall surface extending along the sleeve from a first opening at the proximal end to a second opening at the distal end, the inner wall surface forming a channel in the sleeve, the channel having a first portion with a substantially frustoconical shape, wherein the channel of the sleeve is configured to receive a substantially frustconically shaped injection cartridge, to substantially uniformly support the injection cartridge during a transdermal injection operation, and to prevent movement of the injection cartridge out of the distal end of the sleeve.
2. The apparatus of claim 1 wherein the sleeve further comprises a stop edge disposed at the distal end, the stop edge being configured to prevent movement of the injection cartridge out of the distal end of the sleeve.
3. The apparatus of claim 2 wherein the channel includes a second portion extending from the second opening to the first portion of the channel, the second portion having a substantially cylindrical shape.
4. The apparatus of claim 3 further comprising a ring disposed in the second portion of the channel, the ring having a hole with a first inner diameter smaller than a second inner diameter of a distal end of the first portion of the channel and forming the stop edge at a point in the channel where the first portion and the second portion meet.
5. The apparatus of claim 4 wherein the ring is press fit into the second portion of the channel.
6. The apparatus of claim 4 wherein the ring is welded into the second portion of the channel.
7. The apparatus of claim 4 wherein the ring is fixed in the second portion of the channel using an adhesive.
8. The apparatus of claim 1 wherein a portion of an outer wall surface adjacent to the sleeve proximal end includes threads.
9. The apparatus of claim 1 wherein a diameter of the first portion of the channel tapers from a first diameter in a range of 7 mm to 8 mm to a second diameter in a range of 6 mm to 7 mm.
10. The apparatus of claim 1 wherein a thickness of a wall of the sleeve adjacent to the first portion of the channel is in a range of 0.5 mm to 5 mm.
11. The apparatus of claim 1 wherein the sleeve is formed from a stainless steel material.
12. An apparatus for transdermal injection, said apparatus comprising: a cartridge including a proximal end, a distal end, an outer wall surface, an inner wall surface, and an injection nozzle disposed at the distal end of the cartridge, wherein the outer wall surface extends between the proximal end and the distal end and has a substantially frustoconical shape, the inner wall surface extends from a first opening at the proximal end and in a direction from the proximal end to the distal end and forms a channel in the cartridge, the channel having a first portion with a substantially cylindrical shape and a second portion with the injection nozzle disposed therein.
13. The apparatus of claim 12 wherein the second portion is configured to receive the injection nozzle and includes a stop edge configured to prevent the injection nozzle from exiting the cartridge from the distal end.
14. The apparatus of claim 13 wherein the injection nozzle is affixed in the second portion using a welding technique.
15. The apparatus of claim 12 wherein the injection nozzle is integrally formed in the second portion.
16. The apparatus of claim 12 wherein the cartridge includes a plunger disposed in the first portion of the channel.
17. The apparatus of claim 12 wherein a diameter of the outer wall surface tapers from a first diameter in a range of 7.5 mm to 8 mm to a second diameter in a range of 6 mm to 6.5 mm.
18. The apparatus of claim 12 wherein a thickness of a wall of the cartridge along the first portion of the channel is in a range of 0.05 mm to 6 mm.
19. The apparatus of claim 12 wherein the cartridge is formed from a plastic material.
20. An apparatus for transdermal injection, said apparatus comprising: a sleeve including a sleeve proximal end, a sleeve distal end, and a sleeve inner wall surface extending along the sleeve from a first opening at the sleeve proximal end to a second opening at the sleeve distal end, the sleeve inner wall surface forming a channel in the sleeve, the channel having a first portion with a substantially frustoconical shape; and a cartridge for insertion into the channel of the sleeve, the cartridge including a cartridge proximal end, a cartridge distal end, and a cartridge outer wall surface extending between the cartridge proximal end and the cartridge distal end, the cartridge outer wall surface having a substantially frustoconical shape conforming to the first portion of the channel; wherein the sleeve inner wall surface is configured to substantially uniformly support the cartridge outer wall surface during an injection operation.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0029] These and other features and advantages of the invention will be apparent from the following detailed description and the accompanying figures, in which:
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DETAILED DESCRIPTION
I. First Embodiment
[0049] As shown in
[0050] For purposes of discussion, it is useful to define a cylindrical coordinate system and to define first and second sections of the cartridge 120. A first section is the set of points that are on the outer surface of the cartridge 120 and that have a circumferential coordinate between 0° and 180°. A second section is the set of points on the outer surface of the cartridge 120 that are not in the first set of points.
[0051] The apparatus further includes a collet having a first leg 110B and a second leg 110A.
[0052] The first leg 110B has a proximal end and a distal end. A first pivot point 112B passes through a foot at the distal end of the first leg 110B. As a result, the first leg 110B can pivot between an open position, as shown in
[0053] Between its proximal and distal ends, the first leg 110B has an outer surface that defines a straight section and a tapered section. The straight section is that portion of the first leg 110B for which the outer surface is parallel to the axis 105 when the first leg 110B is in the closed position shown in
[0054] The first leg 110B engages a vertically-moving first finger 132B that moves along a line parallel to the axis 105. When the first leg 110B is in its open position, as shown in
[0055] Referring now to
[0056] The collet's a second leg 110A has a proximal end and a distal end. A second pivot point 112A passes through a foot at the distal end of the second leg 110A. As a result, the second leg 110A can pivot between an open position, as shown in
[0057] Between its proximal and distal ends, the second leg 110A has an outer surface that defines a straight section and a tapered section. The straight section is that portion of the second leg 110A for which the outer surface is parallel to the axis 105 when the second leg 110A is in the closed position shown in
[0058] The second leg 110A engages a second vertically-moving second finger 132A that moves along a line parallel to the axis 105. When the second leg 110A is in its open position, as shown in
[0059] Referring now to
[0060] It is apparent therefore that when the first and second legs 110A, 110B are in the fully closed position as shown in
[0061] In some embodiments, as shown in
[0062] A particular advantage of having a leg with both a straight section and a tapered section is that once the fingers 132A, 132B are on the straight section, a distally directed force as shown in
[0063] As shown in
[0064] In
[0065] As the fingers 132A, 132B move further in the distal direction, the legs 110A, 110B continue to force the cartridge 120 in the distal direction. By the time the fingers 132A, 132B have reached the top of the straight section, the distal end of the cartridge 120 will have become aligned with the distal end of the legs 110A, 110B so that an injection can be given.
[0066] Fingers 132A, 132B can be moved manually or by an actuator (e.g., motor).
[0067] The cartridge may be made of a plastic, glass or metal. For example, the cartridge is made of a medical-grade plastic having a thin wall and a flange. In another embodiment, the cartridge is in the form of an ampoule having a wall thickness in a range between 0.05 mm and 6 mm
[0068] In the embodiment described above in conjunction with
II. Second Embodiment
[0069] Another embodiment is illustrated in
III. Third Embodiment
[0070]
[0071] A preliminary study was conducted to investigate the effect of supporting a thin-walled plastic cartridge with a collet on cartridge deformation, compared to the deformation of a thick-walled stainless steel cartridge. Three cartridges were subjected to an increasing load ranging from 100 N to 700 N and the output cartridge deformation (mm) was recorded.
[0072] Referring to
IV. Fourth Embodiment
[0073] Referring to
[0074] a. Reinforcing Sleeve
[0075] Referring to
[0076] The cartridge receiving portion 1316 extends from the sleeve proximal end opening 1308 to a first channel transition point 1320. A diameter of the cartridge receiving portion 1316 tapers substantially linearly from a first diameter, D.sub.1 at the proximal end 1306 of the reinforcing sleeve 1204 to a second, smaller diameter, D.sub.2 near at the first channel transition point 1320, resulting in the cartridge receiving portion 1316 having a substantially frustoconical shape. In some examples, the first diameter, D.sub.1 is in a range of 7 mm to 8 mm (e.g., 7.887 mm). In some examples, the second diameter, D.sub.2 is in a range of 6 mm to 7 mm (e.g., 6.04 mm).
[0077] The ring receiving portion 1318 extends from the first channel transition point 1320 to the sleeve distal end opening 1312. A diameter, D.sub.3 of the ring receiving portion 1318 is greater than the second diameter, D.sub.2. A shoulder 1322 is formed at the channel transition point 1320 due to an abrupt change in the diameter of the first channel 1314 from the second diameter, D.sub.2 to the third diameter, D.sub.3. In some examples, the third diameter, D.sub.3 is in a range of 7.938 mm to 8.326 mm.
[0078] The ring receiving portion 1318 of the channel 1314 is configured to fixedly receive a ring 1324. In some examples, the ring 1324 is press fit into the ring receiving portion 1318 such that it rests against the shoulder 1322 and is substantially flush with the sleeve distal end 1306. In other examples, the ring 1324 is glued, welded, or otherwise affixed in the ring receiving portion 1318. An injection channel 1326 extends through the ring 1324 and permits ejection of injectate from the injector head assembly 1200.
[0079] In some examples, the sleeve proximal end 1306 includes threads 1328 for connecting the reinforcing sleeve 1204 to an injector mechanism (not shown). In some examples, the distal end 1310 of the reinforcing sleeve 1204 includes a flared portion 1330 for interfacing with one or more injector head accessories.
[0080] In some examples, the reinforcing sleeve 1204 is formed from a sheet metal material. In some examples, a wall 1380 adjacent to the cartridge receiving portion 1316 has a maximum thickness in the range of 0.5 mm to 5 mm and a minimum thickness in the range of 0.5 mm to 5 mm.
[0081] While specific ranges of diameters and thicknesses are provided for the reinforcing sleeve 1204, it should be noted that the diameters and thicknesses are generally configurable to accommodate a cartridge of any size, as long as the substantially frustoconically shaped cartridge receiving portion of the sleeve conforms to the cartridge.
[0082] Referring to
[0083] The cartridge proximal end 1432 includes a cartridge proximal end opening 1438 and the cartridge distal end 1434 includes a cartridge distal end opening 1440. A second channel 1442 is defined by an inner surface 1444 of the cartridge 1202 and extends along a length of the cartridge 1202 from the cartridge proximal end opening 1438 to the cartridge distal end opening 1440. The second channel 1442 includes a plunger receiving portion 1446 (i.e., a bore) and a nozzle receiving portion 1448.
[0084] The plunger receiving portion 1446 extends from the cartridge proximal end opening 1438 to a second channel transition point 1450. The plunger receiving portion 1446 has a substantially constant, sixth diameter, D.sub.6 along its length, resulting in the plunger receiving portion 1446 having a substantially cylindrical shape. In some examples, the sixth diameter, D.sub.6 is in a range of 5 mm to 6 mm. In general, the sixth diameter, D6 depends on and is made to conform to the actuation system (e.g., the injector mechanism) being used.
[0085] The nozzle receiving portion 1448 extends from the second channel transition point 1450 to the cartridge distal end opening 1440. The nozzle receiving portion 1448 includes a second shoulder 1452 configured to mate with an injection nozzle 1454 such that the injection nozzle 1454 is properly seated in the nozzle receiving portion 1448 and is prevented from exiting the cartridge 1202 via the cartridge distal end opening 1440.
[0086] In
[0087] A plunger 1456 is disposed in the plunger receiving portion 1446 of the second channel 1442. In general, movement of the plunger 1456 along the plunger receiving portion 1446 is substantially unimpeded due to the constant sixth diameter, D.sub.6 of the plunger receiving portion 1446.
[0088] In some examples, the walls 1482 of the cartridge 1202 in a region along the plunger receiving portion 1446 have a maximum thickness in the range of 0.6 mm to 1.2 mm and a minimum thickness in the range of 0.5 mm to 0.6 mm.
[0089] b. Assembly and Operation
[0090] Referring again to
[0091] Therefore, to finalize the assembly of the injector head assembly 1200, a force is applied to the cartridge 1202 and/or the reinforcing sleeve 1204, causing the cartridge 1202 to move into the cartridge receiving portion 1316 of the first channel 1314 until the distal end 1434 of the cartridge 1202 makes contact with the first shoulder 1322 of the cartridge reinforcing sleeve 1204.
[0092] Once assembled, the injector head assembly 1200 is attached to an injector to perform an injection operation. To perform the injection operation, an actuator causes the plunger 1456 to move through the plunger receiving portion 1446 of the second channel 1442 in a direction from the proximal end 1432 of the cartridge 1202 toward the distal end 1434 of the cartridge 1202. The movement of the plunger 1456 causes an increased pressure in injectate present in the plunger receiving portion 1446 of the second channel 1442, which in turn causes ejection of injectate from the injector head assembly 1200 via the injection nozzle 1454 and the injection channel 1326.
[0093] The reinforcing sleeve 1204 substantially fully supports the cartridge and prevents deformation of the cartridge 1202 due to the pressurization of the injectate in the cartridge 1202. Furthermore, little to no compression of the relatively thin plastic walls of the cartridge occurs since a majority of force applied to the cartridge walls is transferred through the walls to the rigid reinforcing sleeve 1204.
[0094] Thus, during an injection operation, as plunger 1454 moves through the plunger receiving portion 1446 of the second channel 1442, pressure rises in the plunger receiving portion 1446. Pressure is exerted on the wall 1482 of cartridge 1202 but the reinforcing sleeve 1204 prevents the pressure from deforming wall 1482 of cartridge 1202. In some examples, the pressure also causes compression of the wall 1482 of cartridge 1202, but the compression is minimal due to thin walls. The first shoulder 1322 formed by the ring 1324 in the ring receiving portion 1318 of the first channel 1314 prevents the distal end 1434 of the cartridge 1202 from separating from the cartridge 1202 and being ejected from the reinforcing sleeve 1204.
V. Fifth Embodiment
[0095] Referring to