Patent Description:
Medical injectors and syringes are well known in the prior art. Medical injectors may include auto-injectors and pen injectors which are capable of delivering selected doses of fluids including liquid medicaments or vaccinations to a patient. Medical injectors typically are configured to receive a standard pre-filled glass or plastic syringe tipped with an injection needle. These devices may include a drive member for advancing a plunger into a syringe barrel to expel a liquid medicament out through the needle. The required manipulation of a standard prior art hypodermic syringe can be inconvenient, particularly where the injection is self-administered in a public environment, and many medication delivery pens, pen injectors, or other self-injectors have been developed to facilitate self-administration of injections.

In order to maintain sterility prior to use and to reduce the risk of incurring an accidental needle-stick, protection of the needle tip is important. Medical injectors are typically supplied with a rubber or plastic cap which guards the needle prior to use. Immediately prior to use, the user must remove the protective cap from the injector, such as by using the cap protector of the present invention.

<CIT> describes a cap assembly mountable to a rigid shield around a needle of a syringe. The cap assembly of <CIT> includes a gripper component and a base cap. In <CIT>, the gripper component includes a support frame and a liner that is deformable when sandwiched between the support frame and the rigid shield. In <CIT>, when the base cap is installed to the gripper component during manufacture, and with the rigid shield disposed in a bore of the gripper component in any rotational orientation relative thereto, the liner is held by the support frame so as to be deformed against and grip the rigid shield for shield removal purposes so as to allow for removal of the rigid shield from around the needle.

Further relevant state of the art for the present invention is described in <CIT>.

In accordance with an embodiment of the present invention, a medical injector includes an injector housing defining a reservoir, a plunger rod, and a stopper engaged with a portion of the plunger rod, the stopper being slidably disposed within the reservoir and sized relative to an interior of the injector housing to provide sealing engagement with a sidewall of the injector housing. The medical injector further includes a needle having a sharpened first end and a second end in communication with the reservoir, a first cap covering the sharpened first end of the needle, and a second cap/cap remover covering at least a part of the first cap. The second cap/cap remover includes a body having a proximal end, a distal end, and a hemispherical member including a gripping component. The second cap/cap remover is engaged with the first cap such that removal of the second cap simultaneously removes the first cap from the first end of the needle. The medical injector may further include a liquid medicament disposed within the reservoir.

The second cap/cap remover rar may engage the first cap via a friction fit. For example, the second cap may include an interior wall defining a cavity in a proximal end of the second cap, such that the cavity is sized and shaped to receive at least a portion of the first cap. A protrusion extends inwardly from the interior wall of the second cap/cap remover and is adapted to frictionally engage the first cap. The protrusion may be an annular ring.

The first cap may be formed from a first material and the second cap/cap remover may be formed from a second material, the first material being different from the second material. In one embodiment, the first cap is formed from an elastomeric sleeve disposed over at least the sharpened first end of the needle. The second material may be harder than the first material.

The hemispherical member is provided adjacent the distal end of the second cap body. The gripping component may include at least one rib extending at least partially about the hemispherical member and at least one trough extending at least partially about the hemispherical member adjacent the at least one rib. In one embodiment, the gripping component includes a plurality of ribs and a plurality of troughs extending circumferentially about the hemispherical member such that the plurality of ribs and the plurality of troughs alternate from a proximal end to a distal end of the hemispherical member. The hemispherical member may further include a flange having a substantially flat distally directed surface.

The present invention is directed to a cap remover according to claim <NUM> which includes a body having a proximal end, a distal end, and an interior wall defining a cavity within the proximal end of the cap body, the cap remover body having a hemispherical member including a gripping component. The gripping component includes a rib extending circumferentially about the hemispherical member and a trough extending circumferentially about the hemispherical member. The cavity is sized and shaped to accommodate a cap disposed on a medical injector at least partially therein. With the cap received within the cavity, the cap remover may remove the cap from the medical injector. The cap remover may further include a protrusion extending inwardly from the interior wall of the cap remover body. The protrusion is adapted to frictionally engage the cap. With the protrusion of the cap remover body engaged with the cap, the cap remover body may disengage the cap from the medical injector upon application of a distally directed force to the cap remover body.

In one embodiment, the gripping component includes a plurality of ribs and a plurality of troughs alternating from a proximal end of the hemispherical member to a distal end of the hemispherical member. The hemispherical member may further include a flange having a substantially flat distally directed surface.

Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner.

The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art.

In the following discussion, "distal" refers to a direction generally toward an end of a medical injector adapted for contact with a patient and/or engagement with a separate device, and "proximal" refers to the opposite direction of distal, i.e., away from the end of a medical injector adapted for engagement with the separate device. For purposes of this disclosure, the above-mentioned references are used in the description of the components of a medical injector in accordance with the present disclosure.

<FIG> illustrate an exemplary embodiment of the present disclosure. Referring to <FIG>, a cap remover or a second cap <NUM> of the present disclosure is illustrated. Referring to <FIG>, in one embodiment, a medical injector <NUM> of the present disclosure includes a first cap <NUM> and a second cap or cap remover <NUM>. The first cap <NUM> may be formed of a plastic and/or rubber guard material. Referring to <FIG>, the first cap <NUM> shields and covers a distal end <NUM> of a needle <NUM>. Referring to <FIG>, the second cap or cap remover <NUM> shields and covers the distal end <NUM> of the needle <NUM> and the first cap <NUM>. In one embodiment, the second cap <NUM> may be formed from a harder material than the first cap <NUM> such that the second cap <NUM> provides a protective covering for the first cap <NUM> when the second cap <NUM> shields the first cap <NUM>. In another embodiment, the second cap <NUM> may be the only cap that shields and covers the distal end <NUM> of the needle <NUM>.

In one embodiment, with the first cap <NUM> covering the distal end <NUM> of the needle <NUM> and with the second cap <NUM> covering the distal end <NUM> of the needle <NUM> and the first cap <NUM>, the second cap <NUM> is engaged with the first cap <NUM> via a friction fit such that removal of the second cap <NUM> simultaneously removes the first cap <NUM> from the distal end <NUM> of the needle <NUM>.

Referring to <FIG>, a medical injector <NUM> includes a needle assembly <NUM> having a needle <NUM>, an injector housing <NUM>, a barrel <NUM> having a reservoir <NUM> for medicament sealed by a septum <NUM>, a stopper <NUM>, a plunger rod <NUM> having a flange <NUM>, a spring <NUM>, a first cap <NUM>, and a second cap or a cap remover <NUM>.

The medical injector <NUM> includes a distal end <NUM> and a proximal end <NUM>. The reservoir <NUM> of the barrel <NUM> is encased within the injector housing <NUM>. In one embodiment, the reservoir <NUM> may be defined by the injector housing <NUM>. In another embodiment, the reservoir <NUM> may be defined by a separate component contained within the injector housing <NUM>, e.g., a cartridge or barrel. The needle assembly <NUM> includes a needle <NUM> and a hub <NUM>. The needle <NUM> includes a distal end <NUM>, formed for insertion into a patient, and a proximal end <NUM>.

The medical injector <NUM> of the present disclosure may be of various forms, including being a syringe, self-injector, auto-injector, or pen injector. In one embodiment, the medical injector <NUM> is well-suited for administering at least one fixed dose. In another embodiment, the medical injector <NUM> is well-suited for administering a series of fixed doses. The medical injector <NUM> may be configured in any way known to be compatible with the plunger rod <NUM>. The medical injector <NUM> may include a reservoir <NUM> for accommodating an injectable medicament, which may be a drug cartridge or formed directly in the medical injector <NUM>. The reservoir <NUM> may have one or more stoppers <NUM> associated therewith.

Referring to <FIG>, the injector housing <NUM> of the medical injector <NUM> includes an upper guard <NUM>, a lower guard <NUM>, and a base <NUM>. The upper guard <NUM> includes a first flange <NUM> and a first tapered wall <NUM>. In one embodiment, the upper guard <NUM> provides a gripping component that includes surfaces for accommodating a user's fingers, such as finger grip indentations or similar structure. For example, the upper guard <NUM> provides ergonomically shaped surfaces that substantially conform to a user's fingertips to aid the user in manipulating the medical injector <NUM> and using the medical injector <NUM> in a medical procedure, and may provide multiple finger grip positions for the user. The upper guard <NUM> allows a user to handle and/or grip the medical injector <NUM> in a variety of different ways.

The lower guard <NUM> includes a second flange <NUM> and a second tapered wall <NUM>. The lower guard <NUM> provides a second gripping component that includes surfaces for accommodating a user's fingers, such as finger grip indentations or similar structure. In one embodiment, the lower guard <NUM> provides a user with vertical stability in hand, precisely during needle insertion with the medical injector <NUM>.

The upper guard <NUM> and the lower guard <NUM> together provide a gripping component that includes surfaces for accommodating a user's fingers to aid the user in manipulating the medical injector <NUM> and using the medical injector <NUM> in a medical procedure.

The base <NUM> includes a flange <NUM> that contacts the skin of a user during use of the medical injector <NUM>. The base <NUM> provides a stability component that stabilizes the medical injector <NUM> on a user's skin during use of the medical injector <NUM>. In one embodiment, the base <NUM> also hides the spring <NUM>.

Referring to <FIG>, the injector housing <NUM>, the upper guard <NUM>, the lower guard <NUM>, and the base <NUM> are configured to provide viewing windows <NUM>. The viewing windows <NUM> allow a user to see the barrel <NUM> that includes the medicament.

Referring to <FIG>, a first cap <NUM> shields and covers the distal end <NUM> of the needle <NUM>. Referring to <FIG>, the second cap or cap remover <NUM> shields and covers the distal end <NUM> of the needle <NUM> and the first cap <NUM>. In one embodiment, the second cap <NUM> may be the only cap that shields and covers the distal end <NUM> of the needle <NUM>.

Referring to <FIG>, the second cap or cap remover <NUM> includes a body <NUM> having a distal end <NUM>, a proximal end <NUM>, a cylindrical portion <NUM> adjacent the proximal end <NUM>, and a hemispherical portion <NUM> adjacent the distal end <NUM>.

The hemispherical portion <NUM> includes an outer wall <NUM>, an inner wall <NUM>, a distal flange <NUM>, a first cavity <NUM>, and a distal wall <NUM>.

The outer wall <NUM> of the hemispherical portion <NUM> provides a gripping component that includes surfaces for accommodating a user's fingers, such as finger grip indentations or similar structure. For example, the outer wall <NUM> of the hemispherical portion <NUM> provides ergonomically shaped surfaces that substantially conform to a user's fingertips to aid the user in handling and grasping the second cap <NUM>.

In one embodiment, the outer wall <NUM> of the hemispherical portion <NUM> includes finger grip indentations <NUM> for providing a gripping component for accommodating a user's fingers. The finger grip indentations <NUM> improve the grip between the second cap <NUM> and the user's fingertips. In one embodiment, the finger grip indentations <NUM> are formed as a plurality of ribs <NUM> and troughs <NUM> extending along the periphery of the outer wall <NUM> of the hemispherical portion <NUM>. In one embodiment, the finger grip indentations <NUM> are formed as a plurality of alternating ribs <NUM> and troughs <NUM> extending circumferentially about the periphery of the outer wall <NUM> of the hemispherical portion <NUM>. The hemispherical portion <NUM> may terminate at a distal flange <NUM> having a substantially flat distal distally directed surface.

In one embodiment, the alternating ribs <NUM> and troughs <NUM> are integrally formed with the second cap <NUM> and provide a visual and tactile cue to the user to instruct the user where to place his or her fingertips.

In one embodiment, the shape of the second cap <NUM> is designed to help disabled people more easily and more conveniently handle the second cap <NUM> and/or the medical injector <NUM>.

The cylindrical portion <NUM> includes an outer cylindrical portion <NUM>, an inner cylindrical portion <NUM>, an outer wall <NUM>, and inner wall <NUM>, defining a second cavity <NUM>. The cylindrical portion <NUM> provides a secure attachment of the second cap <NUM> to the distal end <NUM> of the medical injector <NUM> as shown in <FIG>. Referring to <FIG>, the outer cylindrical portion <NUM> extends proximally from the hemispherical portion <NUM>. Referring to <FIG>, the inner cylindrical portion <NUM> extends into a portion of the hemispherical portion <NUM>. In one embodiment, the outer cylindrical portion <NUM> may include a metallic ring integrated therewith.

Referring to <FIG>, the inner wall <NUM> of the cylindrical portion <NUM> defines a second cavity <NUM> in the proximal end <NUM> of the cylindrical portion <NUM>. Referring to <FIG>, the outer wall <NUM> of the inner cylindrical portion <NUM> and the inner wall <NUM> of the hemispherical portion <NUM> define the first cavity <NUM> therebetween.

The second cavity <NUM> is sized and shaped to receive at least a portion of the first cap <NUM> therein. A protrusion <NUM> may extend inwardly from the interior wall <NUM> toward a longitudinal axis of the body <NUM>. In one embodiment, the protrusion <NUM> is an annular ring. In another embodiment, a plurality of circumferentially spaced protrusions <NUM> extend inwardly from the interior wall <NUM> toward a longitudinal axis of the body <NUM>. The protrusion <NUM> may include a tapered proximal surface angled from the interior wall <NUM> inwardly toward the longitudinal axis of the body <NUM> and downwardly toward the distal end <NUM> of the body <NUM> for aiding the second cap <NUM> in sliding over the first cap <NUM>.

With the first cap <NUM> covering the distal end <NUM> of the needle <NUM> and with the second cap <NUM> covering the distal end <NUM> of the needle <NUM> and the first cap <NUM>, the second cap <NUM> is engaged with the first cap <NUM> such that removal of the second cap <NUM> simultaneously removes the first cap <NUM> from the distal end <NUM> of the needle <NUM>. In one embodiment, the second cap or the cap remover <NUM> is removed from the medical injector <NUM> by applying a distally directed force F to the second cap or cap remover <NUM>, as shown in <FIG>.

In one embodiment, the hemispherical portion <NUM> of the second cap <NUM> provides the above-described gripping component. In one embodiment, the hemispherical portion <NUM> of the second cap <NUM> provides ergonomically shaped surfaces that improve the grip between the second cap <NUM> and the user's fingertips to aid the user in removing the second cap <NUM> from the distal end <NUM> of the needle <NUM> and/or to aid the user in simultaneously removing the second cap <NUM> and the first cap <NUM> from the distal end <NUM> of the needle <NUM>.

In one embodiment, the second cap <NUM> allows a user to handle the second cap <NUM> without finger flexion. In one embodiment, the hemispherical portion <NUM> of the second cap <NUM> provides a gripping component that allows a user to better handle the second cap <NUM> and/or the medical injector <NUM>.

When it is desired to use the medical injector <NUM> of the present disclosure, the second cap <NUM> is used to easily remove the second cap <NUM> and the first cap <NUM> from the distal end <NUM> of the needle <NUM> simultaneously. Referring to <FIG>, with the caps <NUM>, <NUM> removed, the distal end <NUM> of the needle <NUM> is exposed and ready to be positioned adjacent a desired portion of the skin of a user. In one embodiment, the second cap <NUM> may be the only cap that shields and covers the distal end <NUM> of the needle <NUM>.

When it is desired to expel or deliver the medication contained within the barrel <NUM> of the medical injector <NUM>, and with the medical injector <NUM> properly used to contact and pierce the skin of a user, the flange <NUM> of the plunger rod <NUM> and a portion of the injector housing <NUM> can be grasped, e.g., with the user's thumb on the flange <NUM> of the plunger rod <NUM> and with the user's fingers extending around the first flange <NUM> of the upper guard <NUM> of injector housing <NUM>. In this manner, the medical injector <NUM> can be grasped by a user in a well-known and well-recognized manner similar to the operation of a conventional hypodermic syringe. Next, the user effects a squeezing movement between the thumb on the flange <NUM> of the plunger rod <NUM> and four fingers grasping the first flange <NUM> of the upper guard <NUM>, thereby causing the plunger rod <NUM> to move in a direction generally along arrow A (<FIG>).

Movement of the plunger rod <NUM> in the direction generally along arrow A actuates movement of the stopper <NUM> in the direction generally along arrow A toward the distal end <NUM> of the medical injector <NUM>. In this manner, movement of the stopper <NUM> in the direction generally along arrow A forces the medicament fluid contained within the reservoir <NUM> of the barrel <NUM> to be forced out the distal end <NUM> of the needle <NUM> and into the user and/or patient.

After injection of the medicament fluid, the needle <NUM> can be removed from the skin of the patient. In one embodiment, the medical injector <NUM> may include an automatic retraction mechanism for moving the needle <NUM> into the injector housing <NUM> for safe shielding of the needle <NUM> after use. In one embodiment, the spring <NUM> may be used as part of the automatic retraction mechanism.

All of the components of the medical injector <NUM> may be constructed of any known material, and are desirably constructed of medical-grade polymers.

Claim 1:
A cap remover (<NUM>) for a medical injector (<NUM>), the cap remover (<NUM>) comprising:
a cylindrical portion (<NUM>),
and a hemispherical member (<NUM>) including a gripping component,
wherein the cylindrical portion (<NUM>) has an inner wall (<NUM>) extending from a proximal end (<NUM>) to a distal end, and the inner wall (<NUM>) defines a cavity (<NUM>),
the hemispherical member (<NUM>) has a proximal end connected to the cylindrical portion (<NUM>) and extends to a distal end (<NUM>),
the cap remover (<NUM>) is adapted to be positioned on the medical injector (<NUM>) with the distal end of the cylindrical portion (<NUM>) spaced farther from an injector housing (<NUM>) of the medical injector than the proximal end (<NUM>) of the cylindrical portion (<NUM>) and the distal end (<NUM>) of the hemispherical member (<NUM>) spaced farther from the injector housing (<NUM>) than the proximal end of the hemispherical member (<NUM>), and
the cavity (<NUM>) is sized and shaped to accommodate a cap (<NUM>) disposed on the medical injector (<NUM>) at least partially therein, and
with the cap (<NUM>) received within the cavity (<NUM>), the cap remover (<NUM>) may remove the cap (<NUM>) from the medical injector (<NUM>),
wherein
the proximal end of the hemispherical member (<NUM>) has a first diameter and the distal end (<NUM>) of the hemispherical member (<NUM>) has a second diameter, the second diameter being larger than the first diameter.