SYRINGE SAFETY ASSEMBLY
Systems, devices, and methods are provided for providing safe syringe assemblies for injections. The syringe assemblies include a shielding mechanism that covers a syringe needle after an injection is delivered, thereby reducing the risk of a subsequent accidental stab from the needle. The shielding mechanism has a pre-injection configuration in which the needle extends beyond the housing and a post-injection configuration in which at least one component of the syringe assembly covers the needle. In some implementations, the syringe assembly includes a lock that inhibits the assembly from returning to the pre-injection configuration once an injection is delivered. The syringe assemblies may also include a bevel orientation mechanism that allows a user to align a needle bevel to accurately insert a needle for injection.
This application claims the benefit of U.S. Provisional Application No. 61/500,822, filed Jun. 24, 2011, which is hereby incorporated by reference herein in its entirety.
BACKGROUNDMany medical conditions require treatment that includes medication administered through injections or infusions. Injections are often administered on a regular schedule, and patients needing regular injections often inject the medication themselves. Patients may use conventional, single-use hypodermic syringes filled manually using medication ampoules for injections, or medication may be provided to a patient in single-use syringes that are pre-filled with a correct dosage of the medication. In both approaches, the syringes and needles used are disposed following a single injection for safety and health concerns.
Handling and disposal of syringes is a safety concern for both patients and medical professionals. Accidental stabs from handling syringes and needles are a common problem and can cause serious concerns for disease transmission. Typical syringes include a sheath on the needle that a user must remove prior to an injection and replace after the injection for disposal. Removal and replacement of the sheath requires a user to place his or her fingers in close proximity to an unshielded needle and can often lead to an accidental stab. In addition, a sheath is often attached to a syringe such that it will not fall off without a significant amount of force applied by a user, and the force required may lead to a slip and an accidental stab. After an injection is administered, a user handling a syringe may accidentally stab themselves while trying to re-shield or dispose of the used syringe and needle.
In addition to the risk of accidental stabs, conventional syringes may cause difficulties in inserting a needle at the correct location and minimizing the amount of pain caused by injections. Needles are provided with a bevel on the end of the needle that creates a sharp pointed tip to increase the ease with which the needle can be inserted into the skin. The sharp pointed bevel allows a user to accurately target an injection site and insert the needle in a way that reduces pain caused by the insertion. Typical syringes include a needle that is attached to the barrel of the syringe by a threaded attachment that does not allow the needle to rotate. To orient the bevel of the needle, a user may have to hold the syringe at an awkward angle and may have difficulty effectively controlling the syringe and needle.
Elderly patients and patients afflicted with rheumatoid arthritis may have difficulty safely handling and disposing of syringes and needles. The small size of needle covers and the force required to remove them can cause problems for patients who may be weaker or may not have a level of dexterity necessary to safely handle a syringe. In addition to creating an increased risk of accidental stabs from needles, a patient's age or medical condition may also make it more difficult to align a needle for an injection. Patients suffering from arthritis or other joint afflictions may find it painful or even impossible to orient the bevel of a syringe properly for an injection.
More effective syringe systems are needed to address these and other problems posed by currently available syringe systems. There is a need for a syringe system that shields syringe needles and protects a user after an injection is administered without requiring a user to carefully replace a small cap on the needle. There is also a need for syringe systems that facilitate orientation of the needle bevel of a syringe to give accurate injections and reduce patient pain.
SUMMARYDescribed herein are systems, devices, and methods for providing a syringe assembly that automatically shields a needle of the syringe assembly after an injection is delivered. Also disclosed herein are systems, devices, and methods for providing a syringe assembly that allows a user to easily orient a needle and needle bevel prior to delivery of an injection.
Systems, methods, and devices for a syringe safety assembly are provided. An assembly contains a syringe for delivery of a medication dose via injection. A shielding mechanism is included that shields a syringe needle after an injection is delivered. A syringe assembly has an unshielded configuration in which a needle extends from the assembly and a shielded configuration in which a needle does not extend from the assembly. A transition from an unshielded configuration to a shielded configuration occurs when the syringe assembly is actuated during delivery of an injection. A locking mechanism locks the syringe assembly in the shielded configuration and prevents the needle from being re-exposed from the assembly.
Systems, methods, and devices for a syringe safety assembly are provided. An assembly contains a syringe for delivery of a medication dose via injection. A bevel orientation mechanism allows a user to fully rotate the syringe and orient the bevel of a syringe needle prior to injection. An assembly includes a bevel orientation collar that can be actuated and rotated by a user. The bevel orientation collar is coupled to a syringe within the assembly either directly or indirectly, and rotation of the bevel orientation collar rotates the syringe.
The systems, devices, and methods described herein provide syringe assemblies that allow a user to administer a more efficient and safe injection. In certain implementations, the syringe assemblies accommodate a variety of different syringes, including standard hypodermic syringes that may be filled from medication ampoules by a user as well as pre-filled syringes that are provided with a set dosage of medication already loaded into the syringe. A syringe assembly may be provided with a syringe already included in the assembly, or may be provided as a shell into which a syringe can be placed by a user.
The syringe assemblies described herein include a shielding mechanism that shields a syringe needle after an injection is delivered to a patient. The shielding mechanism is triggered when a patient delivers an injection and deploys a shield that covers the needle as it is removed from the injection site. The mechanism may lock the assembly in the shielded configuration with the needle covered so that further pressure applied by a user does not re-expose the needle. With the needle shielded, the syringe assembly may be safely handled until the syringe and needle are carefully disposed. The entire assembly may also be disposable.
In certain embodiments, a syringe assembly includes a housing with one or more retaining clips and a retainer. The housing includes an inner chamber with an opening for receiving a syringe and an opening for allowing a needle of the syringe to extend beyond the housing. A syringe placed into the housing may be pre-filled with a set dosage of medication or may be empty and filled with medication by a user prior to injection. A sheath is positioned within the housing, along with a spring that biases the housing towards one opening of the housing and biases the sheath towards another opening of the housing. The syringe assembly may be in an unshielded configuration with a needle exposed or a shielded configuration with the needle guarded within the housing. Actuation of the syringe assembly, for example, by delivery of an injection, causes the retainer to move in a direction perpendicular to the biasing spring force and release the retaining clips. The components of the assembly move from an unshielded configuration to a shielded configuration upon release of the retaining clips. In certain embodiments, a syringe assembly includes a top cover coupled to the housing.
In certain embodiments, retaining clips of a syringe assembly are provided as static components. The retaining clips extend from a housing and do not move relative to the housing during activation of the syringe assembly or during movement of components from an unshielded configuration to a shielded configuration. The movement from an unshielded to a shielded configuration may occur during delivery of an injection, and may be caused by the depression of a plunger into the syringe assembly. The plunger interacts with internal components of the syringe assembly to trigger the transition, and exerts force on a retainer that causes the retainer to move perpendicular to a longitudinal axis of an inner chamber of a housing to release the shielding mechanism. In certain embodiments, the plunger does not contact the retainer directly but contacts an intermediate actuator, which contacts and exerts a force on the retainer to cause the retainer to move perpendicular to a longitudinal axis of an inner chamber of a housing.
In certain embodiments, a syringe assembly includes a locking mechanism that prevents a syringe assembly from returning to an unshielded configuration once it has transitioned to a shielded configuration. A sheath is positioned within the housing of a syringe assembly and includes a locking mechanism that locks the housing and sheath in the shielded position. The locking mechanism may include a shelf on the housing that contacts legs on the sheath. In some embodiments, a syringe assembly includes first and second sheaths held within a housing. A lockout mechanism may include legs on the first sheath that contact a shelf on the second sheath. The legs may be compliant to allow the shelf to pass the legs when the first sheath and second sheath move from an unshielded configuration to a shielded configuration, and may be rigid to prevent the shelf from moving back past the legs once the assembly is in the shielded configuration.
In certain embodiments, a syringe assembly includes an outer top at a first opening of a housing, with a sheath held within the housing by the outer top. The outer top may be configured to receive a syringe inserted into the syringe assembly, and may have an opening shaped to match a shape of a collar on an inserted syringe.
In certain embodiments, the spring of a syringe assembly is positioned at a top opening of a sheath of the assembly. The spring may contact an interior sheath of the assembly directly to exert a biasing force on the sheath. The spring may be positioned around an interior chamber of a syringe assembly housing, and may surround a portion of a syringe inserted into the syringe assembly.
The syringe assemblies described herein may include a mechanism that facilitates orientation of a needle bevel for an injection. In certain implementations, internal components of a syringe assembly and a syringe held by the syringe assembly are configured to rotate independent of the outer housing. A user-actuatable component provides an easy way for a user to turn the needle and orient the syringe within the syringe assembly and the bevel of the needle extending from the syringe assembly.
In certain embodiments, a syringe assembly with a bevel orientation mechanism includes a housing having an inner chamber with a first opening for receiving a syringe and a second opening to allow a needle of a syringe to extend beyond the housing. The assembly includes a collar coupled to the second opening of the housing. Rotation of the collar relative to the housing drives rotation of a syringe inserted into the syringe assembly. In certain implementations, the collar is an independent component that can be separated from the housing. A user rotates the collar, for example, in a 360 degree rotation, to orient a needle bevel for an injection. In some embodiments, the collar directly contacts a syringe held within the syringe assembly and causes the syringe to rotate when the collar is rotated. In some embodiments, a holding component is positioned within the collar to operatively couple the collar to a syringe inserted into the syringe assembly. In certain embodiments, a collar is releasably coupled to a pull cap that covers a needle of a syringe assembly.
In certain embodiments, a syringe assembly with a bevel orientation mechanism includes a first sheath positioned within a housing. The first sheath may be coupled to a collar attached to the housing. The first sheath may include clips that are configured to mate with pockets on the collar to operatively couple the first sheath and the collar. The clips may be configured to be releasable to allow the sheath to move along a longitudinal axis of the inner chamber of the housing.
In certain embodiments, a syringe assembly with a bevel orientation mechanism includes a first sheath and a second sheath operatively coupled to the first sheath. The second sheath is configured to receive a syringe inserted into the syringe assembly. The syringe assembly may also include an outer top coupled to the second sheath, and the outer top may be shaped to match a shape of a collar of an inserted syringe. The syringe assembly may also include an inner housing that holds the second sheath within the housing of the syringe assembly. The inner housing preferably does not rotate relative to the housing, but may allow the second sheath and outer top to rotate relative to the housing. The inner housing may have at least one cutout that holds the outer top and allows rotation of the outer top while the inner housing remains static. Rotation of the collar may cause rotation of the inner sheath, outer sheath, and a syringe inserted into the syringe assembly relative to the housing.
In certain embodiments, a syringe assembly includes a housing having an inner chamber with a first opening for receiving a syringe and a second opening to allow a needle of the syringe to extend beyond the housing, with a sheath positioned within the housing. A spring exerts a force biasing the housing in a direction towards the second opening of the housing and biasing the sheath in a direction towards the first opening of the housing. A locking mechanism resists the biasing force of the spring, and a plate rotates to release the locking mechanism upon actuation of the syringe assembly.
In certain embodiments, a syringe assembly includes an inner sheath having a first opening and an inner chamber for receiving a syringe, and an outer housing having a second opening to allow a needle of the syringe to extend beyond the housing. A spring exerts a force biasing the sheath in a direction towards the first opening and biasing the housing in a direction towards the second opening. A locking mechanism resists the biasing force of the spring, and an activating member moves in a direction towards the second opening to release the locking mechanism upon actuation of the syringe assembly.
The foregoing and other objects and advantages will be appreciated more fully from the following further description thereof, with reference to the accompanying drawings. These depicted embodiments are to be understood as illustrative and not as limiting in any way:
To provide an overall understanding of the systems, devices, and methods described herein, certain illustrative embodiments will now be described. For the purpose of clarity and illustration, the systems and methods will be described with respect to a shielding assembly for pre-filled syringe cartridges. It will be understood by one of ordinary skill in the art that the systems and methods described herein may be adapted and modified as is appropriate, and that the systems and methods described herein may be employed in other suitable applications, such as for other types of syringes or injectors, and that such other additions and modifications will not depart from the scope hereof.
The syringe assembly 100 is configured to allow a syringe to rotate freely within the housing 104. This full rotation allows the user to orient the bevel of the needle 114 in any desired orientation, which can increase the convenience of use and allow the user to deliver a more painless injection. To orient the bevel, a user rotates the bevel orientation collar 108 while holding on to the handles 112 of the syringe assembly 100. The bevel orientation collar 108 is coupled to the syringe contained within the housing 104, either directly or indirectly, via internal components of the syringe assembly 100. Rotation of the bevel orientation collar 108 causes the syringe held within the housing 104 to rotate and allows the user to orient the bevel in any desired orientation.
The syringe assembly 100 also contains a shielding mechanism that shields the needle 114 and protects the user after an injection is delivered. When the plunger 102 is fully depressed to deliver the injection, it activates the internal shielding mechanism of the syringe assembly 100. In certain embodiments, the shielding mechanism causes internal components of the housing 104 and a syringe held within the housing 104 to move upward, withdrawing the needle 114 into the housing 104. With the needle 114 withdrawn into the housing 104, the user is shielded from the needle 114 as shown in
The transition from the unshielded configuration to the shielded configuration of the syringe assembly 100 begins when a user administers an injection. During the injection, the plunger 102 interacts with internal components of the syringe assembly 100 to unlock and trigger the needle shielding mechanism.
When the syringe assembly 100 is in the unshielded configuration shown in
The retainer 116 and retaining clips 138 hold the syringe assembly 100 in the unshielded configuration. In particular, the retaining clips 138 extend upward from an inner surface of the housing 104 and, as shown in
When the plunger 102 is depressed to deliver an injection, the downward driving motion of the plunger 102 releases the resistance provided by the interaction between the retainer 116 and the retaining clips 138, triggering the needle shielding mechanism. More particularly, as shown in
An intermediate actuator, such as actuator 238 discussed below with respect to
The release of retaining clips 138 by retainer 116 is shown in
The upward movement of the syringe barrel 124 caused by the force exerted by the spring 118 withdraws the needle 114 into the housing 104. When the spring 118 is fully extended, the syringe assembly 100 is in the completely shielded configuration shown in
The relative movement of the exterior housing 104 of the syringe assembly 100 with respect to the internal components shields the needle 114.
Following an injection, a lockout mechanism of the syringe assembly 100 prevents the needle 114 from being re-exposed once the syringe assembly 100 is in the shielded configuration shown in
According to certain embodiments, the syringe assembly 100 is locked in the shielded configuration by an interaction between the inner sheath 120 and outer sheath 122 components as they move relative to each other when the spring 118 extends.
As shown in
The needle shielding and locking mechanisms discussed above with respect to
In the pre-injection configuration shown in
As shown in
From the pre-injection configuration shown in
In the post-injection configuration, the locking tabs 326a and 328a are aligned in the release slot 334 in the configuration shown in
With the tab 328a positioned to move up the second arm 346 of the release slot 334, the contact between the tab 328a and the corner 344 that holds the springs 306a and 306b in their compressed state is released. As a result, after the injection, the two springs extend and separate the inner house 304 and outer housing 302, as shown in
The syringe shields shown in
A forward shielding syringe assembly 400 is shown in
When an injection is delivered, the interaction between the platforms 422a and 422b and the clips 424a and 424b is interrupted by activating members 416a and 416b of the syringe assembly 400. When the plunger 408 is depressed to deliver an injection, a lower surface 418 of the plunger contacts the activating members 416a and 416b and transfers the distal force of the injection to the activating members. Each of the activating members 416a and 416b then contacts one of the clips 424a and 424b, respectively, and pushes the clips outwards in the directions shown by arrow 426 and 428. A close-up view of this activation is shown in
The distal movement of the outer sheath 412 shields the needle 406 in the post-injection configuration of the assembly 400, shown in
In addition to the platform and clip interaction shown in assembly 400, other triggering mechanisms may be employed in a forward shielding syringe assembly. For example,
In the pre-injection state shown in
In the post-injection configuration shown in
Another embodiment of a forward shielding triggering mechanism is shown in
As described in the above embodiments, a syringe assembly that includes a needle shielding mechanism can provide for safer handling of used needles. A shielding mechanism can trigger automatically when an injection is delivered and shield a needle after injection to protect a user against accidental stabs with a used needle. Additional features may also be provided to enhance the ease of use and convenience of the syringe assembly for a user. One such feature is a bevel orientation mechanism that allows a user to orient a needle bevel prior to delivering an injection using the syringe assembly.
In certain embodiments, a bevel orientation mechanism is included with the syringe assembly 100. As shown in
When the syringe assembly 100 is made, the outer top 128 is dropped into the inner housing 126 to hold the outer top 128, inner sheath 120, and outer sheath 122 within the syringe assembly 100 and create the inner chamber that receives the syringe. The inner housing 126 does not rotate within the syringe assembly 100. To allow for unrestrained rotation of the outer top 128, the inner housing 126 has cutouts on either side to accommodate the geometry of the rim of the outer top 128, and allow a portion of the rim of the outer top 128 to extend beyond the sides of the inner housing 126. The accommodating cutouts thus allow the outer top 128 to rotate within the inner housing 126, while the inner housing 126 remains static. In certain embodiments, the inner housing 126 has a different geometry than the outer top 128 that could interfere with rotation of the outer top 128. For example, in the embodiment shown in
The outer top 128 has an opening 162 that receives a collar of a syringe barrel inserted into the syringe assembly 100. The shape of the opening is shaped to match the shape of the syringe barrel collar. As shown in
During operation of the bevel orientation mechanisms shown herein, rotation of the bevel orientation collar 108 is transferred to rotation of the needle 114, allowing the user to orient and position the needle bevel. To operate the bevel orientation mechanism, a user first manually rotates the bevel orientation collar 108. The notches 154 in the bevel orientation collar 108 hold the clips 152 of the inner sheath 120 and force the clips 152 and inner sheath 120 to rotate along with the bevel orientation collar 108. When inner sheath 120 rotates, the shelf 148 of inner sheath 120 exerts a force on the edges 158 of the slot 156 in the outer sheath 122, which causes the outer sheath 122 to rotate along with the inner sheath 120. The edges 158 of the slot 156 transfer the rotation force of the outer sheath 122 to the outer top 128, which is locked into the slot 156 by clips 134 on the outer top 128. The outer top 128 holds a collar of a syringe barrel in its opening, and the rotation of the outer top 128 causes the barrel 124 of the syringe held within the syringe assembly 100, along with the needle 114 extending from the housing 104 of the syringe assembly 100, to rotate.
As shown in
As shown in
A retainer 218 is placed into the assembly of the inner housing 212 and outer top 210, as shown in
As shown in
As shown in
A syringe 232 is placed into the assembly as shown in
The top cover 236 and an actuator 238 are placed onto the assembly as shown in
It is to be understood that the foregoing description is merely illustrative and is not to be limited to the details given herein. While several embodiments have been provided in the present disclosure, it should be understood that the disclosed systems, devices, and methods, and their components, may be embodied in many other specific forms without departing from the scope of the disclosure.
Variations and modifications will occur to those of skill in the art after reviewing this disclosure. The disclosed features may be implemented, in any combination and subcombinations (including multiple dependent combinations and subcombinations), with one or more other features described herein. The various features described or illustrated above, including any components thereof, may be combined or integrated in other systems. Moreover, certain features may be omitted or not implemented.
Examples of changes, substitutions, and alterations are ascertainable by one skilled in the art and could be made without departing from the scope of the information disclosed herein. All references cited herein are incorporated by reference in their entirety and made part of this application.
Claims
1. A syringe assembly, comprising:
- a housing having a retaining clip and an inner chamber with a first opening for receiving a syringe and a second opening to allow a needle of the syringe to extend beyond the housing;
- a first sheath positioned within the housing;
- a spring that exerts a force biasing the housing in a direction towards the second opening of the housing and biasing the first sheath in a direction towards the first opening of the housing; and
- a retainer that moves in a direction perpendicular to the spring force to release the retaining clip upon actuation of the syringe assembly.
2. The syringe assembly of claim 1, wherein the retaining clip is static and does not move relative to the housing when the syringe assembly is actuated.
3. The syringe assembly of claim 1, wherein the syringe assembly is actuated by the depression of a plunger into the syringe.
4. The syringe assembly of claim 3, wherein the plunger contacts the retainer and exerts a force that causes the retainer to move perpendicular to the spring force.
5. The syringe assembly of claim 3, wherein:
- the plunger contacts an intermediate actuator; and
- the intermediate actuator contacts the retainer and exerts a force that causes the retainer to move perpendicular to the spring force.
6. The syringe assembly of claim 1, wherein the syringe assembly moves from an unshielded configuration to a shielded configuration upon actuation of the syringe assembly and the first sheath includes a locking mechanism that locks the housing and first sheath in the shielded configuration and prevents the syringe assembly from returning to the unshielded configuration.
7. The syringe assembly of claim 6, wherein the locking mechanism comprises a shelf on the housing that contacts legs on the first sheath.
8. The syringe assembly of claim 1, further comprising an outer top at the first opening of the housing, wherein the first sheath is held within the housing by the outer top.
9. The syringe assembly of claim 8, wherein the outer top is configured to receive a syringe inserted into the syringe assembly.
10. The syringe assembly of claim 9, wherein an opening of the outer top is shaped to match a shape of a collar of an inserted syringe.
11. The syringe assembly of claim 1, further comprising a second sheath positioned within the housing.
12. The syringe assembly of claim 11, wherein the first sheath includes a locking mechanism comprising legs on the first sheath that contact a shelf on the second sheath.
13. The syringe assembly of claim 12, wherein the legs are angled to allow the legs to deflect as the shelf passes the legs when the first sheath and second sheath move from an unshielded configuration to a shielded configuration and prevent subsequent deflection, blocking the shelf from moving back past the legs once the syringe assembly is in the shielded configuration.
14. The syringe assembly of claim 11, wherein the spring is positioned at a top opening of the second sheath.
15. The syringe assembly of claim 11, wherein the spring contacts the second sheath directly to exert a biasing force on the second sheath.
16. The syringe assembly of claim 1, wherein the spring surrounds at least a portion of a syringe inserted into the syringe assembly.
17. The syringe assembly of claim 1, further comprising a top cover coupled to the housing.
18. The syringe assembly of claim 1, wherein the syringe is pre-filled with a dosage of medication.
19. The syringe assembly of claim 1, wherein the syringe is empty and configured to be filled with medication by a user prior to injection.
20. A method of making a syringe assembly, comprising:
- providing a housing having a retaining clip, said housing having an inner chamber with a first opening for receiving a syringe and a second opening to allow a needle of the syringe to extend beyond the housing;
- positioning a retainer to interact with the retaining clip, wherein the retainer moves in a direction perpendicular to a spring force to release the retaining clip upon actuation of a syringe;
- placing a sheath within the housing; and
- positioning a spring to exert a force biasing the housing in a direction towards the second opening of the housing and biasing the sheath in a direction towards the first opening of the housing.
21-38. (canceled)
39. A syringe assembly, comprising:
- a housing having an inner chamber with a first opening for receiving a syringe and a second opening to allow a needle of the syringe to extend beyond the housing;
- a sheath positioned within the housing;
- a spring that exerts a force biasing the housing in a direction towards the second opening of the housing and biasing the sheath in a direction towards the first opening of the housing;
- a locking mechanism that resists the biasing force of the spring; and
- a plate that rotates to release the locking mechanism upon actuation of the syringe assembly.
Type: Application
Filed: Dec 29, 2014
Publication Date: Jun 25, 2015
Inventors: Anthony Torris (Montclair, NJ), Alistair Bramley (Brooklyn, NY), Daniel Formosa (Piermont, NY), Eric Freitag (Brooklyn, NY)
Application Number: 14/584,145