Patent Description:
Rectal suppositories are used to administer a predetermined drug dosage to treat a variety of diseases and symptoms. Rectal suppositories are designed to melt inside the body allowing the active pharmaceutical ingredient (API) contained within the rectal suppository to be absorbed by the mucosa lining of the rectum in order to treat a patient locally or systemically. Suppositories are typically used to administer drugs to patients who cannot take the drug orally for a variety of reasons, such as uncontrollable vomiting or nausea, chronic illnesses, and gastrointestinal diseases. In addition, children, the elderly, and patients unable to care for themselves may also use rectal suppositories to treat a variety of symptoms and conditions. In other cases, specific drugs can cause extreme stomach upset or are inactivated in the stomach or liver and are, therefore, better tolerated by rectal administration.

It is common practice to administer rectal suppositories manually using a finger while the patient is, for example, lying on their left side in the fetal position, and after having emptied their bowel. After insertion of the suppository, the patient is instructed to remain on their side in the fetal position for an extended period of time (e.g., at least <NUM> minutes) while the suppository has time to melt within the rectum and the body begins the absorption process.

Applicators for administering rectal suppositories have been proposed. <CIT> discloses a suppository applicator. <CIT> discloses an applicator. <CIT> discloses a lead in instrument for suppositories with a piston in an open cylinder forming the bottom of a receptacle for suppository.

Particular aspects of the invention are set out in the appended claims. Devices and associated methods for single-use insertion of a suppository are provided.

A method for providing a single-use suppository insertion device according to an example teaching includes activating a disabling feature of a barrel or a plunger during operational motion of the plunger relative to the barrel, such as during insertion of or withdrawal away from a suppository.

Activating the disabling feature can include engaging, e.g., irreversibly engaging, the disabling feature of the plunger or the barrel with a structural element of the barrel or the plunger. Activating the disabling feature can include activating the disabling feature during insertion of or withdrawal away from a suppository, such as withdrawal of the plunger through the barrel and away from the suppository.

The structural element can include a feature complementary to the disabling feature and can engage the disabling feature with the complementary feature. For example, the complementary feature of the structural element can include a concave surface, and the disabling feature can include a convex surface. The structural element can extend from an inner surface of the barrel, and can be a spacing element, to space the plunger from the barrel.

The disabling feature can be a protrusion extending outward from an outer surface of the plunger. For example, the disabling feature and the structural element can form a ratchet, to allow motion in one direction but prevent motion in another (e.g., opposite) direction.

The structural element can be coupled to or defined by the barrel, and the disabling feature can be coupled to or defined by the plunger. Engaging the disabling feature with the structural element causes the structural element to uncouple from the barrel. For example, a flange can be provided that couples the structural element to the barrel. The flange can be configured to break at a perforation of the flange to cause the structural element to uncouple, which may be a full or partial uncoupling, from the barrel.

The method for providing a single-use suppository insertion device can further include coupling the plunger to an insert receivable in the barrel, the insert including the disabling feature. The plunger can include a fitting to couple to the insert.

A single-use suppository device according to an example embodiment includes a barrel, a plunger configured to be movably coupled to the barrel, and a disabling feature of the barrel or the plunger configured to be activated during operational motion of the plunger relative to the barrel, such as during insertion of or withdrawal away from a suppository.

The single-use suppository insertion device can further include a structural element of the barrel or the plunger configured to engage with the disabling feature of the barrel or the plunger during insertion of or withdrawal away from the suppository to activate the disabling feature.

The structural element, such as a spacing element, fin, protrusion etc., can be configured to maintain a gas flow path associated with the device. The structural element can be configured to engage irreversibly with the disabling feature and can include a feature complementary to the disabling feature. For example, the complementary feature of the structural element can include a concave surface, and the disabling feature can include a convex surface. The structural element can be configured to engage with the disabling feature during withdrawal of the plunger through the barrel.

The device can further include an insert receivable in the barrel and configured to couple to the plunger. The insert can include, or form, the disabling feature. The plunger can include a fitting to couple to the insert, whereby the insert moves with plunger during operational motion of the plunger relative to the barrel. The plunger can further cooperate with the insert to activate the disabling feature.

Another example embodiment of the single-use suppository insertion device may include a barrel, a plunger configured to be movably coupled to the barrel, and means for activating a disabling feature of the plunger or the barrel during operational motion of the plunger relative to the barrel, such as during insertion of or withdrawal away from a suppository.

The means for activating the disabling feature can include a structural element, or equivalents thereof, of the barrel or the plunger configured to engage with the disabling feature of the barrel or the plunger during insertion of or withdrawal away from the suppository.

Embodiments of the present invention can provide several advantages. A disabling feature, which may be provided at the barrel, the plunger, or both, can render the suppository insertion device inoperable after one time use. For example, the disabling feature, once engaged, can prevent retraction of plunger through the barrel, so that the barrel cannot be re-loaded with another suppository. The disabling feature can include a destructive component, such as one or more break-away elements, that renders the insertion device inoperable after one-time use. For example, when the break-away element(s) breaks, the plunger may no longer be engaged with the barrel, leaving the plunger to rattle around in the barrel. In other examples, the disabling feature is irreversibly engaged during operational motion of the plunger relative to barrel. Embodiments can include one or more flow paths that allow gas to flow into or out of the body during insertion of or withdrawal from the suppository, to ensure proper placement of the suppository in the desired anatomical location.

The foregoing will be apparent from the following more particular description of example embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments of the present invention.

Examples of devices and methods for inserting a suppository are described in <CIT>, and <CIT>.

Further examples of devices for inserting a suppository are described in <CIT> as <CIT>.

Examples of devices and methods for manufacturing a suppository are described in International Patent Application No. <CIT> as <CIT>.

A ratchet is commonly understood to be a locking device or mechanism that permits movement of a part of an apparatus in one direction only, e.g., a lever or spring-loaded catch. A ratchet can include a pawl or detent for preventing backward motion while allowing forward motion of an element of the ratchet.

<FIG> illustrates an example teaching of an applicator (insertion device) <NUM> configured to insert a suppository, e.g., a rectal suppository, <NUM> into a human or animal according to a teaching of the present disclosure. The insertion device <NUM> is configured for one-time use, as further described below. The device <NUM> can include means for activating a disabling feature of the plunger or the barrel during operational motion of the plunger relative to the barrel, which may be during insertion of or withdrawal away from a suppository.

As shown in <FIG>, the device <NUM> can include a barrel <NUM> and a plunger <NUM>. The barrel <NUM> has a gripping end <NUM> and an insertion end <NUM> and can be appropriately sized and shaped to fit within a patient's anal canal. The barrel <NUM> is further configured to define a gas flow path <NUM> allowing gas to freely flow through the barrel <NUM> when positioned within the anal canal. The plunger <NUM>, which has a gripping end (e.g., a finger interface end) <NUM> and an insertion end <NUM>, is appropriately sized and shaped to extend through the barrel <NUM>. A stepped portion <NUM> is provided at the gripping end <NUM> of the plunger. The stepped portion <NUM> can be configured to ensure that a gas flow path associated with the device <NUM>, e.g., gas flow path <NUM>, is not obstructed during use of the device. The plunger <NUM> can be configured to be substantially longer than the barrel, thereby allowing the plunger <NUM> to extend beyond the end of the barrel <NUM>. For example, the barrel <NUM> may be approximately <NUM> in length whereas the plunger <NUM> may be approximately <NUM> in length.

As illustrated in <FIG> and <FIG>, the plunger <NUM> is configured to be movably (e.g., slidably) coupled to the barrel <NUM>. The plunger <NUM> may be further configured to maintain a second gas flow path <NUM> that allows gas to freely flow through the plunger <NUM> as the plunger is withdrawn from the rectum and anal canal after the suppository <NUM> has been inserted to a desired position. Thus, as the suppository <NUM> is being inserted, the barrel <NUM> maintains a gas flow path <NUM> allowing gas to escape. As the plunger <NUM> is being withdrawn, the plunger's gas flow path <NUM> and the barrel's gas flow path <NUM> are maintained as the plunger is withdrawn from the suppository <NUM>, and the barrel <NUM> and plunger <NUM> are removed from the patient's anal canal. The gas flow paths, <NUM> and <NUM>, allow gas to escape as the barrel <NUM> and the plunger <NUM> are removed from the body preventing or reducing the need to release the gas in the form of flatulence.

The device <NUM> can further include an insert <NUM> receivable in the barrel <NUM> and configured to couple to the plunger <NUM>. The insert <NUM> can include, or provide, the disabling feature configured to be activated during operational motion of the plunger <NUM> relative to the barrel <NUM>, for example, during insertion of or withdrawal away from a suppository. The plunger <NUM> can include a fitting <NUM> to couple to the insert <NUM>. In the example shown, the insert <NUM> includes one or more protrusions <NUM> that extend inward from an inside wall of the insert. The fitting <NUM> of the plunger <NUM> includes one or more complementary features <NUM> to engage the one or more protrusions <NUM> of the insert. The fitting <NUM> is configured to couple to the insert <NUM> and apply a force to the insert to cause a portion of the insert to expand. The barrel <NUM> can be configured to restrain expansion of the insert <NUM>, such as while the insert <NUM> is at least partially within the barrel. Other ways of coupling the plunger <NUM> to the insert <NUM> and allowing the insert to expand may be used.

As illustrated in <FIG>, the insert <NUM> fits within the barrel <NUM> and allows for gas flow path(s) to be maintained. The insert <NUM> can be configured to expand, once coupled to the plunger <NUM>, to prevent re-use of the insertion device <NUM>. As illustrated, the insert <NUM> can include one or more longitudinal slots <NUM> at one end of the insert. The slots <NUM> allow the insert <NUM> to expand, e.g., to flare or increase in circumference. As illustrated in <FIG>, when the insert <NUM> is pushed beyond the insertion end <NUM> of barrel <NUM> by action of the plunger <NUM>, the insert expands due to the interaction of the fitting <NUM> and the insert <NUM>. The expanded insert <NUM>' has a flared end <NUM> that cannot pass back into the barrel, thereby preventing retraction of the plunger <NUM> and re-loading of the device <NUM> with another suppository. The insert <NUM> can also be manufactured in an expanded state, such as shown in <FIG>, and then constrained within the barrel during assembly of the device <NUM>. The insert is allowed to return to its expanded state by action of the plunger <NUM>.

The plunger <NUM> can engage with the insert <NUM> before or after loading of the suppository <NUM>. As shown, the fitting <NUM> is positioned at the insertion end <NUM> of the plunger <NUM>, but may be positioned anywhere along the length of the plunger.

In an alternative embodiment of an insertion device <NUM> illustrated in <FIG>, the device <NUM> includes a barrel <NUM>, a plunger <NUM> and an insert <NUM>. <FIG> shows device <NUM> in a locked state, such as after insertion of a suppository. In the locked state of device <NUM>, the plunger <NUM> and insert <NUM> will not move backward. The plunger <NUM> and insert <NUM> are similar to the plunger <NUM> and insert <NUM> of <FIG>. The barrel <NUM> includes structural elements <NUM> that extend inwardly. The structural elements <NUM> can be fins or other spacing elements that are configured to maintain a gas flow path associated with the barrel <NUM>. The insert <NUM> can be dislodged from a position within the barrel <NUM>, by action of the plunger <NUM>, and can expand at the back end, as illustrated in <FIG>. The expanded back end <NUM> of insert <NUM> engages with the structural elements <NUM>, in a ratchet-like fashion, to prevent backward movement of the insert <NUM>. Because the plunger <NUM> is coupled to the insert <NUM>, the plunger <NUM> is also prevented from moving backward, e.g., retracting out of the barrel <NUM>. In this way, the insert <NUM> cannot be returned to a position within the barrel <NUM>. Thus, the insert <NUM> provides the disabling feature that, in cooperation with the fins <NUM>, prevents re-use of the device <NUM>.

<FIG> illustrate an alternative embodiment of an insertion device <NUM> that includes a barrel <NUM> and a plunger <NUM> configured to be movably coupled to the barrel. The barrel <NUM> has an insertion end <NUM> and a gripping end <NUM>, and further includes structural elements, e.g., fins <NUM>, which can function as spacing elements to maintain a gas flow path <NUM> associated with the device <NUM>. There may be four fins <NUM>, as illustrated in <FIG>, and the fins can provide a space <NUM> within the barrel <NUM> for receiving the plunger <NUM>.

As with plunger <NUM> of device <NUM>, the plunger <NUM> has a gripping end (e.g., a finger interface end) <NUM> and an insertion end <NUM>. The plunger <NUM> is appropriately sized and shaped to extend through the barrel <NUM>. A stepped portion <NUM> is provided at the gripping end <NUM> of the plunger <NUM>. The stepped portion <NUM> can be configured to ensure that a gas flow path associated with the device <NUM>, e.g., gas flow path <NUM>, is not obstructed during use of the device. The plunger <NUM> can be configured to be substantially longer than the barrel <NUM>, thereby allowing the plunger <NUM> to extend beyond the insertion end <NUM> of the barrel <NUM>.

As illustrated in <FIG>, one or more flaps <NUM> are provided that extend outward from an outer surface of the plunger <NUM>. As shown, the flaps <NUM> can extend outward from plunger <NUM> at an acute angle and in a direction away from insertion end <NUM> of the plunger. As exemplified in <FIG> and <FIG>, there can be two flaps <NUM>. The flaps <NUM> can be resilient and may be spring-loaded. The flaps <NUM> can be configured to bend, e.g., elastically deform, when compressed against the plunger <NUM> by fins <NUM>, such as when the plunger is advanced into the barrel. The flaps <NUM> can be sized and shaped such that the fins <NUM> will bend the flaps irrespective of the relative rotation of the plunger and the barrel. <FIG> illustrate two different stages of advancement of the plunger <NUM> into barrel <NUM>.

As illustrated in <FIG>, and in cross-section in <FIG>, the flaps <NUM> are bent and held close to the plunger <NUM> as they pass through the portion of the barrel <NUM> that includes the fins <NUM>. As shown in <FIG>, the flaps <NUM> expand after passing past the end of the fin portion of the barrel <NUM>. The expanded flaps <NUM> engage the fins <NUM> and prevent retraction of the plunger <NUM>, locking the plunger against the barrel and thereby preventing re-use of the device <NUM>. Thus, the flaps <NUM> provide a disabling feature that, in cooperation with the fins <NUM>, prevents re-use of the device <NUM>. The fins <NUM> can include a feature complementary to the flaps <NUM>. For example, the fins can include a concave surface to engage the tips of the flaps <NUM>. The fins <NUM> and flaps <NUM> can form a ratchet mechanism.

As with plunger <NUM>, the plunger <NUM> may be further configured to maintain a second gas flow path <NUM> (<FIG> and <FIG>) that allows gas to freely flow through the plunger <NUM> as the plunger is withdrawn from the rectum and anal canal after the suppository has been inserted to a desired position.

<FIG> is a sectional view of the barrel <NUM> of the device <NUM> of <FIG>. Four fins <NUM> extend into an inner lumen of the barrel and provide space <NUM> for the plunger <NUM>.

<FIG> is a sectional view of the plunger <NUM> of the device <NUM> of <FIG>, illustrating the gas flow path <NUM> that extends through the body of the plunger <NUM>. Also shown are two flaps <NUM> that extend radially outward from the body of the plunger.

<FIG> is a sectional view of the device <NUM> of <FIG>, illustrating a stage of advancement of the plunger <NUM> into barrel <NUM>, including compression of flaps <NUM> by fins <NUM>, as described above. Also shown is gas flow path(s) <NUM>, maintained between the plunger <NUM> and barrel <NUM>.

With any of the single-use insertion devices described herein, a mechanism can be provided to prevent premature advancement of the plunger into the barrel, thus preventing premature activation of the disabling feature. The mechanism can be an insert or a component of the barrel, the plunger, or both. The insert or component can prevent the device from locking prematurely, such as while a user is handling the device, loading the suppository, or at any other time before the suppository has been delivered. The mechanism can include a break-away locking mechanism or a removable clip or cuff, as will be described next with respect to <FIG>.

<FIG> illustrate two example components that can prevent the insertion device from locking prematurely by preventing the plunger from moving forward prematurely.

<FIG> illustrates insertion device <NUM>' that is similar to device <NUM>, except that a break-away member <NUM> is provided to couple barrel <NUM>' and plunger <NUM>' of the device. The break-away member <NUM> keeps the plunger <NUM>' from moving relative to the barrel <NUM>' and, thus, prevents engagement of the disabling feature. The break-away member <NUM> is configured to break away from the barrel <NUM>' and plunger <NUM>' at break points <NUM> and <NUM>, respectively. Once the break-away feature is released from the barrel <NUM>' and plunger <NUM>', the plunger can be advanced into the barrel and the disabling feature (e.g., flaps <NUM>') can engage the structural element (e.g., fins <NUM>') of the barrel.

<FIG> illustrates a removable cuff <NUM> applied to the plunger <NUM> of the device <NUM>. The cuff <NUM> is sized and shaped to prevent the plunger <NUM> from moving forward into the barrel <NUM> until the cuff is removed. This feature can prevent premature engagement of the disabling feature (e.g., flaps <NUM>) with the structural element (e.g., fins <NUM>).

The break-away member <NUM> and cuff <NUM> can be made of the same material as the plunger and the barrel, such as plastic, elastomer, paper, or other suitable material. The break-away member <NUM> and cuff <NUM> can each be separate component or can be co-manufactured (e.g., co-molded) with the plunger, the barrel, or both. Each mechanism <NUM>, <NUM> can be configured to be removed by the user, e.g., broken off, torn off, released, etc., when the user is ready to administer the suppository.

<FIG> illustrate another example embodiment of a single-use suppository insertion device <NUM>. The device <NUM> includes a barrel <NUM> and a plunger <NUM> that is configured to be movably coupled to the barrel. The barrel <NUM> include fins <NUM>, which can be spacing elements configured to maintain a gas flow path <NUM> associated with the device <NUM>, such as gas flow paths described with respect to device <NUM> of <FIG>. As illustrated in <FIG>, there can be four fins <NUM> extending inward from an inside wall of the barrel <NUM> at equally spaced intervals. The fins <NUM> can define a space <NUM> for plunger <NUM>. The plunger <NUM> includes an insertion end <NUM>, which is wider than a mid-portion of the plunger, and a finger interface end <NUM>, which includes a stepped portion <NUM> and which may include a cup-shaped interface portion for interfacing with the user's fingertip. A protrusion <NUM> is positioned along the length of the plunger <NUM>, between the insertion end <NUM> and the finger interface end <NUM>. In the example shown, the protrusion <NUM> is a conical-shaped feature (having a triangular cross-sectional profile) that extends outward from an outer surface of the plunger <NUM>, as illustrated in <FIG> and in sectional view in <FIG>. The protrusion <NUM> can be formed integrally with the body of the plunger <NUM>. Alternatively, the protrusion <NUM> can be glued, bonded, or otherwise attached to the body of the plunger <NUM>. The plunger <NUM> can be solid or hollow and can be configured to define a gas flow path through the plunger, such as is the case with plunger <NUM> of <FIG>.

<FIG> shows the device <NUM> pre-assembly, while <FIG> shows the device in an assembled state, where the plunger <NUM> has been partially inserted into the barrel <NUM>. The insertion portion <NUM> of the plunger is positioned past the end of the fins <NUM>. The protrusion <NUM> is positioned at the gripping end <NUM> of the barrel, before the fins <NUM>.

<FIG> illustrates the device <NUM> locked after first use, the plunger <NUM> having been advanced further into the barrel <NUM>. As shown, the protrusion <NUM> is positioned in respective slots <NUM> of the fins <NUM>. As shown, the plunger <NUM> is locked in that it cannot be retracted from the barrel <NUM> because the engagement of the protrusion <NUM> and the fins <NUM>. The protrusion <NUM> and the fins <NUM> can form a ratchet.

<FIG> illustrates a single-use suppository insertion device <NUM> according to another example embodiment. Similar to device <NUM> of <FIG>, device <NUM> includes a barrel <NUM> having fins <NUM> and also includes a plunger <NUM> slidably disposed in the barrel and having protrusion <NUM>. In device <NUM>, however, locking of the plunger to the barrel occurs at a different position within the barrel as compared to device <NUM>. Unlike fins <NUM> of device <NUM>, fins <NUM> of device <NUM> do not include a slot to receive protrusion <NUM>. Instead, protrusion <NUM> engages fins <NUM> in a locking fashion once the protrusion <NUM> has been advanced past the end of the fins <NUM>, as illustrated in <FIG>.

<FIG> illustrate a barrel <NUM> of an insertion device according to another example teaching. Barrel <NUM> can be used with any of the plungers described herein, such as plungers <NUM>, <NUM>, <NUM>, <NUM>', <NUM> and <NUM>. A flange <NUM> couples a structural element <NUM> to the barrel <NUM>. Here, the structural element <NUM> is a spacing element. The flange <NUM> is configured to break at a perforation <NUM> (<FIG>) of the flange to cause the structural element <NUM> to uncouple from the barrel <NUM> when a user attempts to retract the plunger after one-time use of the insertion device. Uncoupling of the element <NUM> from the barrel <NUM> is irreversible and renders the device in-operable. For example, the plunger can be coupled to an insert or can include a protrusion or flap, as described herein, to engage the structural element <NUM>. Engagement occurs by movement of the plunger relative to barrel, such as when the user advances the plunger during insertion of the suppository or when the user withdraws the plunger from the suppository. For example, the structural element <NUM> can break away, such that the plunger is no longer engaged with the barrel. This can leave the plunger to rattle around in the barrel.

Described herein are example embodiments of a single-use suppository insertion device <NUM>, <NUM>, <NUM>, <NUM>', <NUM>, <NUM> that include a barrel, a plunger and a disabling feature. Embodiments of the single-use suppository insertion device can further include a structural element of the barrel or the plunger configured to engage with the disabling feature of the barrel or the plunger during insertion of or withdrawal away from the suppository to activate the disabling feature. The structural element can be configured to engage irreversibly with the disabling feature and can include a feature complementary to the disabling feature. For example, the complementary feature of the structural element can include a concave surface, and the disabling feature can include a convex surface. The structural element can extend from an inner surface of the barrel and can be a spacing element. The disabling feature can be a protrusion extending outward from an outer surface of the plunger. For example, the disabling feature and the structural element can form a ratchet. The structural element can be coupled to or defined by the barrel, and the disabling feature can be coupled to or defined by the plunger. Engagement of the disabling feature with the structural element can cause the structural element to uncouple from the barrel. The structural element can be configured to engage with the disabling feature during withdrawal of the plunger through the barrel.

Claim 1:
A single-use suppository insertion device (<NUM>, <NUM>, <NUM>, <NUM>) comprising:
a barrel (<NUM>, <NUM>, <NUM>, <NUM>) sized and shaped to fit within a patient's anal canal;
a plunger (<NUM>, <NUM>, <NUM>, <NUM>) being axially movable relative to the barrel and configured to be movably coupled to the barrel;
a disabling feature (<NUM>, <NUM>, <NUM>, <NUM>) of the plunger configured to be activated during operational motion of the plunger relative to the barrel and to render the suppository insertion device inoperable after one-time use, the plunger including a mid-portion, an insertion end that is wider than the mid-portion, and a finger interface end, wherein the disabling feature is positioned along the mid-portion of the plunger; and
a structural element (<NUM>, <NUM>, <NUM>, <NUM>) of the barrel is configured to engage irreversibly with the disabling feature of the plunger to activate the disabling feature, wherein the structural element includes plural fins (<NUM>, <NUM>, <NUM>, <NUM>) extending from an inner surface of the barrel at circumferentially spaced intervals, each fin extending axially along a length of the barrel.