NEEDLE COVER
20220126025 ยท 2022-04-28
Inventors
- Sergio Rubinstein (Buffalo Grove, IL, US)
- Samuel Kanosky Rosenberg (Orange Village, OH, US)
- Russell R. Stepke (Chicago, IL, US)
- Richard Mazursk (Riverwoods, IL, US)
- Todd Herliz (Chicago, IL, US)
- Josh Harker (Elk Grove Village, IL, US)
- Mark W. Godfrey (Murrieta, CA, US)
- Stephen M. Jokela (Murrieta, CA, US)
Cpc classification
A61M5/326
HUMAN NECESSITIES
A61M2005/325
HUMAN NECESSITIES
A61M2005/3267
HUMAN NECESSITIES
A61M2005/3247
HUMAN NECESSITIES
A61M5/3202
HUMAN NECESSITIES
International classification
A61M5/32
HUMAN NECESSITIES
Abstract
A single-use cover assembly that obscures a substantial majority or an entirety of an injection needle from view before, during, and after an injection procedure. The cover assembly includes a housing and a needle sleeve that retracts and extends by sliding axially within the housing. The needle sleeve carries a locking collar that moves from a first position to a second position once the needle sleeve is fully retracted. In the first position the locking collar allows retraction of the needle sleeve from a fully extended position. In the second position, a portion of the locking collar covers a tip of the needle, thereby preventing retraction of the needle sleeve from the fully extended position.
Claims
1. A single-use cover, comprising: a first member generally comprising a needle and configured to couple to a medical device configured to perform an injection procedure; a second member configured to move axially and rotationally with respect to the first member between a first position and a second position initially without substantial impediment, the second member comprising a channel extending along at least some of the axial length of the second member and configured to receive the needle such that the first position obscures a distal tip of the needle from view; a biasing member configured to bias the second member toward the first position; and wherein movement of the second member from the second position to the first position automatically engages the least one locking member to thereby inhibit the second member from returning to the second position.
2. The cover of claim 1, wherein first member further comprises a radially inwardly extending shoulder and the second member further comprises a radially outwardly extending flange configured contact the shoulder.
3. The cover of claim 2, wherein movement of the second member from the second position to the first position seats the flange against the at least one locking member.
4. The cover of claim 1, wherein the second member is configured to move from a third position to the first position without engaging the at least one locking member, wherein the third position is between the first and second positions.
5. The cover of claim 4, wherein the third position exposes the distal tip of the needle a sufficient distance to pierce a septum on a vial.
6. The cover of claim 4, further comprising a cap configured to inhibit the second member from engaging the at least one locking member.
7. The cover of claim 1, wherein in the second position a distal end of the second member is about even with a distal end of the first member.
8. A single-use protective cover, comprising: a housing generally surrounding a needle and configured to connect to a syringe; a sleeve configured to move in a first stage with respect to the housing between an extended position and a retracted position substantially without impediment, the sleeve comprising a needle aperture and a needle channel extending axially along the sleeve and configured to receive the needle such that a distal tip of the needle is covered by the sleeve in the extended position and is exposed in the retracted position; a biasing member configured to bias the sleeve toward the extended position; wherein a distal end of the sleeve is substantially flush with a distal end of the housing when the sleeve is in the retracted position; and wherein at least one locking member engages the sleeve in a second stage as the sleeve moves from the retracted position to the extended position and the engagement obstructs the sleeve from moving to the retracted position to thereby inhibit reuse of the protective cover.
9. The protective cover of claim 8, wherein the extended position of the sleeve substantially obscures the needle from view.
10. The protective cover of claim 8, wherein movement of the sleeve automatically engages the at least one locking member.
11. The protective cover of claim 8, wherein the cover need not require more than one hand to operate.
12. The protective cover of claim 8, wherein the distal end of the sleeve further comprises a plurality of projections configured to engage a patient's pressure-receptor nerves to thereby inhibit the sensation of pain.
13. The protective cover of claim 8, wherein the housing further comprises a radially inwardly extending shoulder and the sleeve further comprises a radially outwardly extending flange configured to seat against the shoulder.
14. The protective cover of claim 8, wherein the flange contacts the at least one locking member and the biasing member is configured to be biased by the flange and the housing.
15. The protective cover of claim 8, wherein movement of the sleeve radially displaces the at least one locking member.
16. The protective cover of claim 8, wherein the sleeve is configured to move from a partly retracted position to the extended position without engaging the at least one locking member.
17. The protective cover of claim 16, wherein the partly retracted position of the sleeve exposes the distal tip of the needle a distance sufficient to pierce a septum on a vial.
18. The protective cover of claim 8, further comprising a cap configured to limit the retraction of the sleeve to the partly retracted position to thereby inhibit unintentional engagement of the at least one locking member.
19. The protective cover of claim 8, wherein the needle cover is configured to withdraw fluid from a vial without engaging the at least one locking member.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0008]
[0009]
[0010]
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[0021]
DETAILED DESCRIPTION
[0022] It is to be understood that the invention is not limited in its application to the details of construction and the arrangements of the components set forth in the following description or embodiments, or illustrated in the drawings. The invention is capable of other embodiments and of being practiced or being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.
[0023]
[0024] Although the illustrated cover assembly 10 is configured to be coupled to and removed from a syringe assembly, the cover assembly 10 may instead be integrally formed with the syringe assembly. In either case, the syringe assembly is generally of a known type suitable for the withdrawal and injection of fluids or other solutions from and into the body by way of the cover assembly 10. In the illustrated construction, the cover assembly 10 includes a base in the form of a generally cylindrical housing 14 that defines a central axis 18. The housing 14 defines or is coupled to a needle hub 22 that can be configured for either removable or permanent attachment to the syringe assembly, or that may be integrally formed with the syringe assembly. For example, the needle hub 22 may include internal or external threads or other suitable coupling, latching, or locking features such as tabs, slots, projections, pressure/snap fits, and the like, which may be provided in various combinations on various portions of the needle hub 22 for coupling to the syringe assembly. The coupling features engage corresponding features provided on the syringe assembly to removably couple the cover assembly 10 to the syringe assembly. Alternatively, the needle hub 22 may be permanently fixed (e.g. by sonic welding, adhesives, pressure/snap fits, or the like) or integrally formed with the syringe assembly. In the embodiment of
[0025]
[0026] The needle hub 22 includes a coupling portion 50 that engages the syringe assembly and the upper portion 30 of the housing 14, and a cylindrically reduced support portion 54 that extends axially from the coupling portion 50 and supports the needle 42. The support portion 54 also includes a plurality (e.g. four) of radially and axially extending ribs 58. Each rib 58 includes an axially-facing end surface 62 that is substantially normal to the central axis 18. The ribs 58 each have a substantially equal axial length, such that the end surfaces 62 lie in substantially the same plane.
[0027] The lower portion 34 of housing 14 cooperates with the upper portion 30 to define a central chamber 66. An end 70 of the lower portion 34 includes a radially inwardly extending shoulder 74 that defines an opening 78 that communicates with the chamber 66. The opening 78 slidingly receives a needle sleeve 82 that in turn receives and covers the needle 42. The needle sleeve 82 is substantially cylindrical and includes an inner end 86 positioned within the chamber 66 and an outer end 90. The inner end 86 includes a radially outwardly extending flange 94 that seats against the shoulder 74 of the lower portion 34. The inner end 86 also includes a substantially annular and axially extending rib 96 that locates a biasing member in the form of a spring 98. The spring 98 engages and extends between the inner end 86 of the needle sleeve 82 and the coupling portion 50 of the needle hub 22. The spring 98 biases the needle sleeve 82 toward an extended position (
[0028] As shown in
[0029] The needle sleeve 82 includes an inner surface 102 that defines a generally cylindrical needle chamber 106. The needle chamber 106 is divided into an upper chamber 106a and a lower chamber 106b by a substantially annular wall 108 that extends radially inwardly from the inner surface 102. In the lower chamber 106b, the needle sleeve 82 defines a first, generally wedge-shaped recess 110 that is recessed with respect to the inner surface 102. The first recess 110 is positioned substantially adjacent the annular wall 108 and oriented such that the wider portion of the wedge shaped first recess 110 is nearer to the inner end 86 of the needle sleeve 82 and the narrow or pointed portion of the first recess 110 is nearer the outer end 90 of the needle sleeve 82.
[0030] The needle sleeve 82 also defines a second generally wedge-shaped recess 114 oriented similarly to the first recess 110 (e.g. the wide end is nearer the inner end 86 and the narrow end is nearer the outer end 90) and recessed with respect to the inner surface 102. The second recess 114 is axially spaced from the first recess 110 and positioned nearer the outer end 90 of the needle sleeve 82. The first and second recesses 110, 114 are substantially radially aligned with one another along the inner surface 102. The needle sleeve 82 also includes a ramp 118 that extends radially inwardly from the inner surface 102 and is positioned just above (as viewed in the Figures) the second recess 114.
[0031] The outer end 90 of the needle sleeve 82 includes an end wall 122 that closes the needle chamber 106 and defines an opening in the form of a central aperture 126 through which the needle 42 extends when the needle sleeve 82 is retracted, as discussed further below. A plurality of axially and radially extending ribs or projections 130 extend from the end wall and away from the needle chamber 106. In the illustrated construction, the projections 130 are arranged generally in the shape of an asterisk that is centered about the central aperture 126. During use, the projections 130 are configured to engage the skin or tissue of a patient just prior to the tip 46 of the needle 42 coming into contact with the skin or tissue of the patient. In this way, the projections 130 apply pressure to the skin or tissue that stimulates the patient's pressure-receptor nerves near the point of insertion of the needle 42. This stimulation of the pressure-receptor nerves competes or interferes with stimulation of the patient's pain receptor nerves upon insertion of the needle 42. In many patients, stimulation of the pressure-receptor nerves in this manner reduces the perception of pain during insertion of the needle 42.
[0032] While the illustrated needle sleeve 82 includes the projections 130 described above, a number of other configurations are possible, including a flat end surface, a beveled end surface, differently configured or arranged projections, and the like. The specific configuration of the outer end 90 generally will vary depending upon, among other things, the cover assembly's intended field of use (e.g., medical, dental, veterinary, and the like).
[0033] The outer end 90 of the needle sleeve 82 also includes a guide wall 134 that extends axially inwardly from the end wall 122. The guide wall 134 includes an arcuate portion 134a that partially encircles the central aperture 126, and a support portion 134b that extends radially from the arcuate portion 134a to the inner surface 102. The support portion 134b supports the arcuate portion 134a, and the arcuate portion 134a in turn supports and guides the needle 42 toward the central aperture 126 during retraction of the needle sleeve 82, as discussed further below.
[0034] The cover assembly 10 also includes a locking member in the form of a locking collar 138 that cooperates with the needle sleeve 82 to prevent more than a single use of the cover assembly 10, as discussed below. The locking collar 138 includes a generally cylindrical body 142 positioned in the upper chamber 106a and through which the needle 42 extends. The body 142 includes a radially outwardly extending flange 146 on one end, and an arm 150 on an opposite end. The arm 150 extends axially away from the body 142 through an aperture 152 in the annular wall 108 and into the lower chamber 106b. The arm 150 is radially offset from the central axis 18 and includes at its distal end a locking portion in the form of a foot 154 that, in the configuration of
[0035] The locking collar 138 also includes latching tab 158 that extends radially outwardly from the arm 154 between the body 142 and the foot 154. The latching tab 158 extends radially toward the inner surface 102 of the needle sleeve 82, and axially toward the body 142 of the locking collar 138. In the ready-for-use configuration of
[0036]
[0037] Before describing in detail the operation of the cover assembly 10 during an injection procedure, it should be noted that both the housing 14 and the needle sleeve 82 are preferably constructed of materials that are translucent, opaque, or otherwise optically distortive, such that the needle 42 is not visible to the patient before, during, or after the injection procedure. Furthermore, aside from the central aperture 126 through which the needle 42 extends during the injection procedure, the housing 14 and needle sleeve 82 are preferably devoid of slots, openings, or other apertures that would allow a patient to see into the housing 14 or needle sleeve 82 and view the needle 42. Thus, during an injection procedure, any portion of the needle 42 that does not extend through the central aperture 126 will be completely obscured from view by the housing 14 and needle sleeve 82, and any portion of the needle 42 that does extend through the central aperture 126 will be completely obscured from view because it is inside a vial or inside the patient. Of course, in some instances the entire needle 42 may not be completely obscured from view throughout the injection procedure depending upon, among other things, the specific shapes of the end wall 122 and the projections 130, and the angle at which the needle 42 is inserted into the vial and/or the patient's skin or tissue. Because many people become anxious simply at the sight of a needle, the above-described features can significantly reduce the anxiety or fear of the patient and/or the person administering the injection (who may also be the patient in cases of self-injection) to provide a more comfortable overall treatment experience.
[0038] To further reduce anxiety, particularly in children, the housing 14, cap 26, and needle sleeve 82 may be provided with a variety of indicia such as rainbows, balloons, cartoon characters, or other illustrations that are generally considered pleasing and comforting to children. In this way, a child patient may be allowed to choose from a variety of different cover assemblies 10 prior to an injection procedure. The cap 26, in addition or as an alternative to being colored or bearing indicia, may be fabricated to resemble a variety of different cartoon characters or other objects such that, upon removal from the housing 14 prior to an injection procedure, the cap 26 may be presented to a child patient as a distraction during the injection procedure. When fabricated to resemble a cartoon character or other object, the size and generally cylindrical shape of the cap 26 make it particularly well suited for use by the child as a finger puppet. Each of these features provides the opportunity to reduce the anxiety or fear experienced by many children before, during, and after an injection procedure.
[0039]
[0040] As shown in
[0041] As shown in
[0042] As shown in
[0043] As the needle sleeve 82 extends from the housing toward the position illustrated in
[0044]
[0045]
[0046] As shown in
[0047] To draw a dose, a user moves the tip cap portion 28a to the open position, thereby exposing the outer end 90 of the needle sleeve 82 (
[0048] After withdrawal of the dose from the vial, the user removes the needle 42 from the vial and the needle sleeve 82 moves back to the fully extended position. The user may then move the tip cap portion 28a back to the closed position (
[0049] It should be appreciated that the base cap portion 27a may be removably coupled to the housing 14 by any suitable methods, including snap fits, screw fits, friction fits, and the like. Similarly, the tip cap portion 28a and the ring portion 164 may be removably coupled to the base cap portion 27a, using suitable known methods, such as snap fits, screw fits, friction fits, and the like.
[0050] With reference also to
[0051] In addition to the features and components discussed above with respect to the cover assembly 10, the lower portion 34 of the housing 14 of the cover assembly 10a includes axially and radially inwardly extending ribs 172. The ribs 172 are received in corresponding notches (not shown) formed in the flange 94 of the sleeve 82. Engagement between the ribs 172 and the notches substantially prevents relative rotation between the sleeve 82 and the housing 14. Also, the upper and lower housing portions 30, 34 of the cover assembly 10a are coupled by a snap fit connection 174 positioned proximal the needle hub 22. The upper housing portion 30 also includes a plurality of barbs 178 that engage the ribs 58 of the needle hub 22. The barbs 178 are configured to allow insertion of the needle hub 22 into the neck 38 of the upper housing portion 30 but to prevent extraction of the needle hub 22 from the neck 38. The neck 38 is also provided with a shoulder 176 that in some configurations limits axial insertion of the needle hub 22 into the neck 38 such that the ribs 58 are appropriately positioned relative to the housing 14 to affect movement of the locking collar 138 from the first position to the second position, as discussed above.
[0052] The locking collar 138 of the cover assembly 10a includes an extended flange 146 relative to the locking collar 138 of the cover assembly 10. The extended flange 146 extends further toward the needle hub 22, which compensates for the fact that the needle hub 22 of the cover assembly 10a does not extend as far into the housing as the needle hub 22 of the cover assembly 10. Also, as illustrated, the sleeve 82 of the cover assembly 10a is formed of multiple pieces, whereas the sleeve 82 of the cover assembly 10 is formed as a single piece.
[0053] As discussed above, the needle sleeve 82 is biased to extend from the housing and cover the needle 42 substantially any time the needle is not inserted into a vial or container for loading the syringe, or into the skin or tissue of a patient during an injection. The cover assembly 10 thereby eliminates the periods of needle exposure that occur with many conventional syringes and syringe shields before loading of the syringe, between loading of the syringe and the injection procedure, and after the injection procedure. Eliminating needle exposure also hides the needle from view throughout the injection procedure, thereby reducing anxiety and fear in patients. Furthermore, once the injection procedure is complete, the needle sleeve 82 automatically extends to cover the needle 42 and is locked in the fully extended position by the locking collar 138, thereby preventing subsequent use of the needle 42.