Needle-Free Injector
20230025722 · 2023-01-26
Inventors
- Chris Cappello (Golden, CO, US)
- Matt Wixey (Rancho Santa Margarita, CA, US)
- John W. Bingham (Elizabeth, CO, US)
Cpc classification
A61M5/2033
HUMAN NECESSITIES
A61M2005/2013
HUMAN NECESSITIES
A61M5/30
HUMAN NECESSITIES
A61M2005/2073
HUMAN NECESSITIES
International classification
A61M5/30
HUMAN NECESSITIES
Abstract
A needle-free injection device including an outer housing, and an inner housing. The inner housing is moveable within the outer housing between a syringe loading position and a firing position. The needle-free injection device also includes a syringe mount to receive a needle-free syringe at one end of the inner housing. The syringe mount includes an interlocking structure cooperating with the inner housing and outer housing to prevent placement of the needle-free syringe into engagement with the syringe mount unless the inner housing is in the syringe loading position.
Claims
1. A needle-free injection device comprising: an outer housing; an inner housing, the inner housing being moveable within the outer housing between a syringe loading position and a firing position; and a syringe mount to receive a needle-free syringe at one end of the inner housing, the syringe mount comprising an interlocking structure cooperating with the inner housing and outer housing to prevent placement of the needle-free syringe into engagement with the syringe mount unless the inner housing is in the syringe loading position.
2. The needle-free injection device of claim 1 wherein the interlocking structure comprises a pawl configured to rotate to an outward position by contact with a surface of the needle-free syringe as the needle-free syringe is placed into engagement with the syringe mount, and wherein the pawl is biased to rotate to a mounted position upon completion of the engagement of the needle-free syringe with the syringe mount.
3. The needle-free injection device of claim 2 wherein the pawl comprises a tab extending through a corresponding opening defined by the inner housing.
4. The needle-free injection device of claim 3 wherein the tab further extends into an open area defined by the outer housing, when the inner housing is in the syringe loading position.
5. The needle-free injection device of claim 3 wherein the tab contacts an abutment surface defined by the outer housing when the inner housing is not in the syringe loading position, wherein the contact between the tab and the abutment surface prevents the pawl from rotating to the outward position.
6. The needle-free injection device of claim 2 further comprising: a release mechanism; and an eject button in mechanical communication with the release mechanism, wherein articulation of the eject button causes the pawl to rotate to the outward position when the inner housing is in the syringe loading position.
7. The needle-free injection device of claim 6 further comprising an extension from the outer housing that fully or partially shields the eject button when the inner housing is moved from the syringe loading position toward the firing position.
8. The needle-free injection device of claim 2 wherein the inner housing is prevented from moving from the syringe loading position to the firing position if the pawl is in the outward position.
9. The needle-free injection device of claim 1 wherein the needle-free syringe comprises an orientation structure configured to engage with guides on the syringe mount to prevent rotation of the needle-free syringe as the needle-free syringe is placed into engagement with the syringe mount.
10. A method of mounting a needle-free syringe to a needle-free injection device comprising: providing a needle-free injection device comprising: an outer housing; an inner housing, the inner housing being moveable within the outer housing between a syringe loading position and a firing position; a syringe mount to receive a needle-free syringe at one end of the inner housing; and providing an interlocking structure to prevent placement of the needle-free syringe into engagement with the syringe mount unless the inner housing is in the syringe loading position.
11. The method of claim 10 further comprising: causing a pawl of the interlocking structure to rotate to an outward position by contact with a surface of the needle-free syringe as the needle-free syringe is placed into engagement with the syringe mount; and causing the pawl to rotate to a mounted position upon completion of engagement of the needle-free syringe with the syringe mount.
12. The method of claim 11 wherein the pawl comprises a tab extending through an opening defined by the inner housing.
13. The method of claim 12 wherein the tab further extends into an open area defined by the outer housing, when the inner housing is in the syringe loading position.
14. The method of claim 13 further comprising: providing contact between the tab and an abutment surface defined by the outer housing when the inner housing is not in the syringe loading position; and preventing the pawl from rotating outward when the inner housing is not in the syringe loading position by contact between the tab and the abutment surface.
15. The method of claim 11 further comprising: providing the needle-free injection device with a release mechanism; providing the needle-free injection device with an eject button in mechanical communication with the release mechanism; and articulating the eject button to cause the pawl to rotate to the outward position when the inner housing is in the syringe loading position.
16. The method of claim 15 further comprising fully or partially shielding the eject button when the inner housing is moved from the syringe loading position toward the firing position with an extension from the outer housing.
17. The method of claim 11 further comprising preventing the inner housing from moving from the syringe loading position to the firing position if the pawl is in the outward position.
18. The method of claim 10 further comprising: providing the needle-free syringe with an orientation structure; and engaging the orientation structure with guides on the syringe mount to prevent rotation of the needle-free syringe as the needle-free syringe is placed into engagement with the syringe mount.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0041] Unless otherwise indicated, all numbers expressing quantities of ingredients, dimensions reaction conditions and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about”.
[0042] In this application and the claims, the use of the singular includes the plural unless specifically stated otherwise. In addition, use of “or” means “and/or” unless stated otherwise. Moreover, the use of the term “including”, as well as other forms, such as “includes” and “included”, is not limiting. Also, terms such as “element” or “component” encompass both elements and components comprising one unit and elements and components that comprise more than one unit unless specifically stated otherwise.
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[0044] The foregoing position and shape descriptions are provided for convenience only and do not create any limiting configuration. For example, the needle-free injection device 10 is illustrated herein as being substantially cylindrical and sized for convenient hand-held use. The various features, elements, components and methods described herein are however applicable to other shapes, sizes and configurations of device. Thus, terms such as leading end and trailing end are provided merely to aid in the description of the representative embodiment and are not intended to limit the scope of any claimed embodiment.
[0045] As shown in
[0046] In addition, for any configuration of device, a firing position is defined as a configuration between inner and outer housings where injection is enabled. As discussed in detail below the safety and efficiency of a device may be enhanced by providing distinct syringe loading and firing configurations.
[0047] The needle-free injection device 10 also includes an activation button 22 operatively associated with both the outer housing 12 and inner housing 14. As described in detail below, the activation button 22 may be configured to activate various device functions depending upon the positional relationship between the inner housing 14, outer housing 12 and other elements of the needle free injection device 10.
[0048] It may be desired in selected embodiments to provide a housing lock 24 which prohibits movement of the inner housing 14 with respect to the outer housing 12. For example, a housing lock 24 may provide safety by prohibiting movement of the inner housing 14 from the syringe loading position to the firing position during a syringe loading procedure. In the embodiment of
[0049] The needle-free injection device 10 illustrated in
[0050] The device embodiment of
[0051] The specific embodiment illustrated in
[0052] The ability of the functional elements of the needle-free injection device 10 to enhance the safety and reliability of an injection in both the syringe loading position and firing position are described in additional detail below. Initially, it may be noted that the device 10 includes a skin tensioning spring 50 positioned between the outside trailing end of the inner housing 14 and the inside trailing end of the outer housing 12. The skin tensioning spring 50 element may be implemented with a compression spring which has a relatively lower spring constant than the main spring 34. Alternatively, other compression elements such as elastomeric rings or wave washers could be used to implement the skin tensioning spring 50. The skin tensioning spring 50 installed as shown in
[0053] As described above, the activation button 22 may be used to engage a housing lock 24 locking the inner housing 14 into the syringe loading position for syringe loading or other pre-injection tasks. Prior to an injection the housing lock 24 may be released and the nozzle end 52 of a needle-free syringe 20 placed against a patient's skin at the injection site. It is important for both safety and injection consistency that the patient's skin be placed under appropriate tension prior to the needle-free injection. Appropriate skin tension is accomplished in the needle-free injection device 10 as force against the skin by the nozzle end 52 is transferred through the syringe 20 to the inner housing thereby causing the inner housing to move toward the firing position and compressing the skin tensioning spring 50. Thus, as shown by comparing
[0054] As shown in
[0055] Thus, the needle-free injection device 10 is configured to efficiently and accurately receive, hold and eject a needle-free syringe 20. The installed needle-free syringe 20 may be selected from a supply of prefilled syringes. In addition it may optionally be desirable that a syringe can be mounted and ejected without touching the syringe body with an operator's hands to minimize the risk of syringe contamination or operator injury. Accordingly, the needle-free injection device 10 may include a syringe mount 54, an interlocking structure 56, and an ejection mechanism 58 which separately or together enhance several aspects of the safe use of the device.
[0056] For example, as shown in the top cross sectional views of
[0057] The safe and efficient use of the needle-free injection device 10 may be further enhanced if the device is provided with an interlocking structure 56 which prevents the placement of a needle-free syringe 20 into an engagement with the syringe mount 54 unless the inner housing 14 is in the syringe loading position. Alternatively, or in addition to this functionality, the interlocking structure 56 may prevent removal of a needle-free syringe 20 unless the inner housing 14 is also in the syringe loading position. One representative and non-limiting example of an interlocking structure 56 may be viewed in
[0058] In addition, as shown in
[0059] Furthermore, an improperly loaded syringe will prevent the pawls 62 from rotating into secure contact with the grip surface 64 of a needle-free syringe 20. Thus, an improperly loaded syringe will cause tab 70 to extend into the open area 74 within the outer housing 12. Accordingly, a device with an improperly loaded syringe cannot have the inner housing moved into the firing position because tab 70 will interfere with abutment surface 80, preventing movement of the inner housing toward the trailing end of the device.
[0060] Referring back to
[0061] The syringe ejection spring 68 may be selected to provide enough force to completely eject a spent needle-free syringe 20 from the device 10 without requiring a user to touch the needle-free syringe. Alternatively, a device can be configured to only partially release a syringe which may then be manually removed.
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[0063] As noted above, it may be most convenient to remotely prepare multiple needle-free syringes 20 for use with the needle-free injection device 10. For example, one operator could be loading needle-free syringes with an injectable fluid while another operator installs the needle-free syringes into the device and performs injections. Remote filling to a proper pre-determined dosage is facilitated by providing a plunger system 83 which includes a plunger body 32 and a seal 92 sized to fit in fluid-tight engagement with the interior chamber of the syringe, thereby defining a fluid receiving dosage space 94 within a needle-free syringe 20. As shown in
[0064] As shown in
[0065] As shown in
[0066] Proper dose setting may also be accomplished in the absence of the needle-free injection device 10 by using the plunger positioning surface 110 associated with the handle 96 to manually position the hammer surface 102 to be coplanar with the dose setting surface 106. The plunger positioning surface 110 may, as shown in
[0067] The remote filling of a needle-free syringe 20 may be facilitated by providing a filling adapter 114 as shown in
[0068] It may further be noted from
[0069] Returning to
[0070] Alternative embodiments include methods of operating and filling a needle-free injector as described above. For example, one method includes providing a needle-free injection device 10 according to any one of the alternative embodiments described herein. The method further includes activating the activation button 22 to lock the inner housing 14 in the syringe loading position and subsequently loading a needle-free syringe 20 into the injector. An operator may then release the activation button 22 and move the inner housing 14 to the firing position by pressing the nozzle end 52 of the needle-free syringe 20 against the injection site with sufficient force. The injection may then be triggered by activating the activation button 22 when the inner housing is fully in the firing position. Optionally, the method may include steps of loading and ejecting a needle free syringe 20 from the device. Loading and ejection may occur without touching the syringe at any time.
[0071] Another alternative embodiment is a method of filling a needle-free syringe 20 including providing a syringe having a nozzle 104 at one end and a dose setting surface 106 substantially opposite the nozzle 104. The method further includes providing a plunger body 32 in sealed engagement with an inner surface of the syringe 20 where the plunger body 32 further comprises a hammer surface 102. The filling method further comprises positioning the hammer surface 102 to be substantially coplanar with the dose setting surface 106.
[0072] An alternative method of filling a needle-free syringe may include providing a filling adapter 114 with a filling needle 122 in sealed fluid communication with the nozzle 104 of the syringe body. A plunger system 83 including a handle 96 as described above may be placed into engagement with the syringe 20. The plunger body 32 may then be moved forward to the nozzle end of the syringe body. The septum of storage vial of injectable fluid may be pierced with the filling needle 122. The plunger system 83 is then withdrawn by the handle to a position where the break line 98 is beyond the dose setting surface 106. The handle 96 is then removed from the plunger body 32 by separating the shaft 100 at the break line 98. Next, the plunger body 32 may be moved toward the nozzle 104 by applying force against the hammer surface 102 with a plunger positioning surface 110 causing the hammer surface 102 and dose setting surface 106 to become coplanar. Alternatively, the dose may be set by using a surface within the device, for example the leading edge of the hammer 30 to cause the hammer surface to become coplanar with the dose setting surface. Throughout the dose setting operation the filling adapter and needle-free syringe remain in direct fluid communication with the storage vial of injectable fluid, thereby allowing the precise setting of an injection dosage without the waste of any substantial amount of injectable fluid.
[0073] Various embodiments of the disclosure could also include permutations of the various elements recited in the claims as if each dependent claim was a multiple dependent claim incorporating the limitations of each of the preceding dependent claims as well as the independent claims. Such permutations are expressly within the scope of this disclosure.
[0074] While the embodiments described herein have been particularly shown and described with reference to a number of possible variations, it would be understood by those skilled in the art that changes in the form and details may be made to various components or elements without departing from the spirit and scope of the embodiments and that the various embodiments disclosed herein are not intended to act as limitations on the scope of the claims. All references cited herein are incorporated in their entirety by reference.