Patent Description:
Infusion sets are used in the medical field for inserting liquid substances into a patient. Infusion sets are typically constructed by joining multiple translucent polymeric tubing segments to multiple polymeric components. The joints are formed by applying a thin layer of solvent or adhesive on one or both of contacting surfaces and the two surfaces are brought together. Generally, the external shapes of infusion sets have many steps or transition points without smooth transitions. In some cases, the joints/components form acute angles that are prone to get caught on stationary edges or objects.

Document <CIT> discloses a tubing end-piece that interconnects a free end of a piece of tubing and a tubing connector or fitting so that a fluid can flow between the tubing and the fitting or connector. The tubing end-piece includes a body member extending along a longitudinal axis with a bore extending longitudinally therethrough. The body member has an elongated body portion, a doughnut-shaped head portion and a frustoconically-shaped tail portion.

Document <CIT> discloses a trocar system for endoscopic surgery, cap assembly, and related methods are provided. The cap assembly includes a valve housing with an opening formed in line with an axis of the valve housing. The cap assembly also includes a valve positioned adjacent the opening of the valve housing.

Document <CIT> discloses a drug solution circuit capable of preventing backflow of blood that can be installed easily on an injection device. The drug solution circuit is equipped with a first base line through which a first drug solution flows, a second base line through which a second drug solution flows, a subject line connected to the first and second base line, and a first closing part having a closing mechanism for closing an internal circuit.

Document <CIT> discloses a fluid transfer device comprising a hollow piercing element having a first end for receiving a standard syringe nose or other similar medical device and a second end having a tapered tip for accessing fluid inside a medication container is disclosed. In a preferred embodiment, the device has a diskshaped stop for limiting entry of the piercing element into the vial.

The documents <CIT>, <CIT> and <CIT> disclose further medical tube or connector devices.

Infusion sets are moved from one station to another during manufacturing, potentially, with components dangling down. Thus, the infusion sets can get caught on bench top edges or manufacturing equipment. In use, infusion sets can also be moved about extensively, such as when patients are hooked up with an infusion set and a mobile apparatus so that the patients can walk around. Either in manufacturing or in use, if one of the infusion set components is caught on a stationary object, then it results in tugging the line. If there is a weak joint, or still curing joints, then a leak or separation in the infusion set occurs. This can lead to a mere inconvenience to something more serious. It is desirable to provide infusion sets with reduced or eliminated snagging points.

The present disclosure provides infusion sets having with anti-snagging structures to reduce or eliminate snagging of the infusion set during manufacture, storage or use. Components of the infusion may have integral anti-snagging structures and/or anti-snagging components added-on to standard infusion sets or infusion set components.

In one or more aspects, the anti-snagging component is a Y-junction and the sliding surface is a convex curvilinear shape. In one or more aspects, the anti-snagging component is a Y-site having a needleless connector disposed at the second fluid input end and the sliding surface is a convex curvilinear shape.

In one or more embodiments, an anti-snagging component for use in an infusion set is provided. The anti-snagging component includes a covering portion configured to be received by a needless connector on a first input end of a Y-site infusion set component, a tail portion configured to be slidingly connected to an input tube received by a second input end of the Y-site infusion set component, and a sliding surface configured to slidingly guide the Y-site infusion set component past an obstruction without snagging when the infusion set is moved. The covering portion is configured to cover an access point of the needleless connector when the anti-snagging component is engaged with the Y-site infusion set component and the covering portion is removed from the access point of the needleless connector when the anti-snagging component is disengaged from the Y-site infusion set component.

In one or more aspects, the tail portion is comprised of a flexible material. In one or more aspects, the covering portion is a slip-on cap configured to slip over at least the top portion of the needleless connector. In one or more aspects, the slip-on cap has one or more slits to open up the slip-on cap when it is fit over the top portion of the needleless connector. In one or more aspects, the slip-on cap is comprised of a flexible material that stretches when it is fit over the top portion of the needleless connector. In one or more aspects, the slip-on cap includes a top surface configured to cover the top surface of the needleless connector and a partial side wall configured to cover only a portion of a circumference of the needleless connector. In one or more aspects, the covering portion is a screw-on cap configured to screw onto threads of the needleless connector. In one or more aspects, the covering portion is a hood configured to slip over both the first and second input ends of the Y-site infusion set component. In one or more aspects, the covering portion comprises an anti-microbial coating disposed on an inner surface, the anti-microbial coating configured to contact the access point of the needleless connector when the anti-snagging component is engaged with the needleless connector.

Additional features and advantages of the disclosure will be set forth in the description below and, in part, will be apparent from the description or may be learned by practice of the disclosure. The objectives and other advantages of the disclosure will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the disclosure as claimed.

The accompanying drawings, which are included to provide further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the description serve to explain the principles of the disclosure.

Accordingly, dimensions are provided in regard to certain aspects as non-limiting examples.

Infusion sets may be formed from any combination of infusion components and tubing. Typically, the infusion components and tubing are disposable products that are used once and then discarded. The infusion components and tubing may be formed from any suitable material (e.g., plastic, silicone, rubber). As shown in <FIG>, an infusion set <NUM> may include a drip chamber <NUM>, a check valve <NUM> and a roller clamp <NUM> connected together by tubing <NUM>. Infusion set <NUM> may also include a Y-site <NUM> having a Y-shaped junction with an inlet port <NUM> connected to an inlet tube <NUM>, a needleless connector <NUM> and an outlet port <NUM> connected to an outlet tube <NUM>. The needleless connector <NUM> provides a port for the introduction of fluid into and/or removal of air bubbles from the infusion set <NUM>. For example, a needleless syringe (not shown) may be connected to the needleless connector <NUM> in order to add medication to a saline fluid that is gravity fed from a saline bag (not shown) into the drip chamber <NUM>. The infusion set <NUM> may include additional infusion components and may be formed of any combination of components and the tubing <NUM>.

As shown in more detail in <FIG>, the drip chamber <NUM> is connected to an inlet tube <NUM> and an outlet tube <NUM>. Similarly, in <FIG> the check valve <NUM> is connected to an inlet tube <NUM> and an outlet tube <NUM>. <FIG> shows a Y-junction <NUM> having two inlet ports <NUM> and one outlet port <NUM>, where each inlet port <NUM> is connected to an inlet tube <NUM> and the outlet port <NUM> is connected to an outlet tube <NUM>. The Y-site <NUM> shown in <FIG> has an inlet port <NUM> connected to an inlet tube <NUM>, an outlet port <NUM> connected to an outlet tube <NUM> and a needleless connector <NUM>.

Each of the infusion components and junction points of the infusion set <NUM> provide angled surfaces that may be snagged or engaged by equipment and/or surfaces during manufacture of the infusion set. Similarly, the infusion components and junction points of the infusion set <NUM> may also be snagged by medical equipment and/or patients/caregivers during usage of the infusion set <NUM>. For example, end surfaces of the drip chamber <NUM> and the check valve <NUM> are perpendicular to the tubing <NUM>, providing snagging points <NUM> as shown in <FIG>. Similarly, the Y-junction <NUM> and the Y-site <NUM> also have snagging points <NUM>, as shown in <FIG>.

<FIG> shows an example of snagging of a Y-site <NUM> when the infusion set <NUM> is being moved in a direction X. Here, as the infusion set <NUM> is moved (e.g., pulled) in direction X, the snagging point <NUM> formed by the junction between the inlet port <NUM> and the needleless port <NUM> engages with (e.g., is snagged by) a physical object <NUM> (e.g., a table edge, a piece of medical equipment, a hospital bed frame). Depending on the pulling force in the direction X, the inlet tube <NUM> may pull free or loosen from the inlet port <NUM>, thus leading to a defective infusion set <NUM> during manufacture or an infusion set <NUM> having a leak or failure during use.

As shown in <FIG>, an embodiment which is not part of the invention as defined by the appended claims, infusion components may include an anti-snagging structure gusset <NUM>. The gusset <NUM> may be integrally formed as part of an infusion component or the gusset <NUM> may be added to an existing infusion component. The gusset <NUM> may fill a portion or all of the space that defines the snagging point <NUM> described above. For example, <FIG> show a drip chamber <NUM> with multiple gussets <NUM> formed on the bottom of the drip chamber <NUM>. Each gusset <NUM> may have a curvilinear shape that provides an anti-snagging surface (e.g., sliding surface) <NUM> that slides along and over a physical object during movement of the infusion set <NUM>. Similarly, a check valve <NUM> may have gussets <NUM> formed on both the top and bottom of the check valve <NUM> to prevent snagging of the check valve <NUM> by a physical object when moving in either direction.

The gusset <NUM> may be any shape (e.g., triangular, convex, concave) that provides the sliding surface <NUM> over which an object may slide without snagging. The sliding surface <NUM> may extend from across an area that would define a snagging point (e.g., snagging point <NUM>) in the absence of the gusset <NUM>. For example, the sliding surface <NUM> of the gussets <NUM> on the drip chamber <NUM> extend from a drip chamber end surface <NUM> to an outlet port end surface <NUM> as shown in <FIG>. Similarly, as shown in <FIG>, the sliding surface <NUM> of some of the gussets <NUM> on the check valve <NUM> extend from a check valve end surface <NUM> to an inlet port end surfaces <NUM>, and other gussets <NUM> on the check valve <NUM> extend from a check valve end surface <NUM> to an outlet port end surface <NUM>. As shown in <FIG>, each of the drip chamber <NUM> and the check valve <NUM> have four gussets <NUM> spaced apart at ninety degree angles, however, the disclosure is not limited as such. Accordingly, any number of gussets <NUM> may be used and the gussets <NUM> may be disposed in any desired positioning or spacing.

As shown in <FIG>, an embodiment which is not part of the invention as defined by the appended claims, an anti-snagging structure webbing <NUM> is provided The webbing <NUM> may be integrally formed as part of an infusion component, the webbing <NUM> may be added to an existing infusion component and/or the webbing <NUM> may be formed as a separate component to be added to the infusion set <NUM>. The webbing <NUM> may be any desired shape and size. The webbing <NUM> may be configured to connect to the tubing <NUM> of the infusion set <NUM>. For example, as shown in <FIG>, a Y-site <NUM> includes the webbing <NUM> having a bell-curve shape with one end <NUM> connected at the input port <NUM> and another end (e.g., connection point) <NUM> connected to the input tube <NUM>. Here, the webbing <NUM> is positioned such that a sliding surface <NUM> causes a physical object to slide away from the Y-site <NUM> and avoid snagging on the snagging point <NUM> or the needleless connector <NUM>. A similar webbing <NUM> is shown for a Y-junction <NUM> as shown in <FIG>. Here, the webbing <NUM> has a bell-curve shape with one end <NUM> connected at an input port <NUM> and another end <NUM> connected at the input tube <NUM>. In yet another example, a Y-junction <NUM> may have a partially semicircular shaped webbing <NUM> connected to an input port <NUM>.

The examples shown in <FIG> are not limiting. For example, the webbing <NUM> may have any shape and size with a sliding surface <NUM> that is configured to move the infusion component past a physical object without snagging. In addition, the webbing <NUM> may be a separately formed infusion set component where both ends of the webbing <NUM> connect to tubing <NUM> and the webbing <NUM> may slide along the tubing <NUM> until positioned next to a Y-site <NUM>, a Y-junction <NUM> or any other infusion component.

As shown in <FIG>, an anti-snagging structure (e.g., cap) <NUM> is provided. The cap <NUM> has a covering portion (e.g., cap portion) <NUM> and a tail portion <NUM>. The cap portion <NUM> may be a slip-on cap that is configured to slip over a needleless connector <NUM> of a Y-site <NUM>. The cap portion <NUM> may be a deformable or flexible (e.g., soft) material that stretches as it fits over the needleless connector <NUM>. The cap portion <NUM> may have one or more slits <NUM> so that the cap portion <NUM> opens up to some degree (e.g., expands the circumference of the leading edge) as the cap portion <NUM> fits over the needleless connector <NUM>. The tail portion <NUM> may be flexible and have a tube connection point <NUM> for tethering the tail portion <NUM> to a tube <NUM> (e.g., input tube <NUM>). The tail portion <NUM> has a sliding surface <NUM> configured to move the Y-site <NUM> past a physical object without snagging. The cap <NUM> may slide onto the tube <NUM> and then slide towards the Y-site <NUM> until the cap portion <NUM> is snapped onto the needleless connector <NUM>. In addition to preventing snagging of the Y-site <NUM> when the cap <NUM> is in position, the cap portion <NUM> has the additional benefit of covering the needleless connector <NUM>, thus reducing or eliminating contact with contaminants. The cap portion <NUM> may include a coating (e.g., chlorohexidine) configured to act as an antimicrobial on an access point <NUM> of the needleless connector <NUM>.

As shown in <FIG> and <FIG>, an anti-snagging structure (e.g., cap) <NUM> is provided. The cap <NUM> has a covering portion (e.g., cap portion) <NUM> and a tail portion <NUM>. The cap portion <NUM> may be a slip-on cap that is configured to slip over a needleless connector <NUM> of a Y-site <NUM>. The cap portion <NUM> may have a top surface <NUM> that fits over a top surface (e.g., the access point) of the needleless connector <NUM> and a side wall <NUM> that is partially open such that the side wall <NUM> does not encircle the entire perimeter of the needleless connector <NUM>. The tail portion <NUM> may have a tube connection point <NUM> for tethering the tail portion <NUM> to a tube <NUM> (e.g., input tube <NUM>). The tail portion <NUM> has a sliding surface <NUM> configured to move the Y-site <NUM> past a physical object without snagging. The cap <NUM> may slide onto the tube <NUM> and then rotate around the tube <NUM> until the cap portion <NUM> is snapped onto the needleless connector <NUM>. In addition to preventing snagging of the Y-site <NUM> when the cap <NUM> is in position, the cap portion <NUM> has the additional benefit of covering the access point <NUM> of the needleless connector <NUM>, thus reducing or eliminating contact with contaminants. The cap portion <NUM> may include a coating (e.g., chlorohexidine) configured to act as an antimicrobial on an access point <NUM> of the needleless connector <NUM>.

As shown in <FIG>, an anti-snagging structure (e.g., cap) <NUM> is provided. The cap <NUM> has a covering portion (e.g., cap portion) <NUM> and a tail portion <NUM>. The cap portion <NUM> may be a screw-on cap that is configured to screw onto threads <NUM> of a needleless connector <NUM> of a Y-site <NUM>. The cap portion <NUM> may have a top surface <NUM> that fits over a top surface of the needleless connector <NUM> and a side wall <NUM> that fully encircles the perimeter of the needleless connector <NUM>. The tail portion <NUM> may have a tube connection point <NUM> for tethering the tail portion <NUM> to a tube <NUM> (e.g., input tube <NUM>). The tail portion <NUM> has a sliding surface <NUM> configured to move the Y-site <NUM> past a physical object without snagging. The tube connection point <NUM> of the cap <NUM> may slide onto the tube <NUM> and slide down the tube <NUM> to bring the cap portion <NUM> into position to be threaded onto the needleless connector <NUM>. In addition to preventing snagging of the Y-site <NUM> when the cap <NUM> is in position, the cap portion <NUM> has the additional benefit of covering the access point <NUM> of the needleless connector <NUM>, thus reducing or eliminating contact with contaminants. The cap portion <NUM> may include a coating (e.g., chlorohexidine) configured to act as an antimicrobial on an access point <NUM> of the needleless connector <NUM>.

As shown in <FIG>, an anti-snagging structure (e.g., hood) <NUM> is provided. The hood <NUM> has a covering portion <NUM> and a tail portion <NUM>. The covering portion <NUM> may be a hood or shroud that is configured to slip over both a needleless connector <NUM> and an inlet port <NUM> of a Y-site <NUM>. The covering portion <NUM> may be a deformable or flexible (e.g., soft) material that stretches as it fits over the top of the Y-site <NUM>. The tail portion <NUM> may be flexible and have a tube connection point <NUM> for tethering the tail portion <NUM> to a tube <NUM> (e.g., input tube <NUM>). The hood <NUM> has a sliding surface <NUM> configured to move the Y-site <NUM> past a physical object without snagging. The hood <NUM> may slide onto the tube <NUM> and then slide towards the Y-site <NUM> until the covering portion <NUM> covers some or all of the inlet port <NUM> and the needleless connector <NUM>. In addition to preventing snagging of the Y-site <NUM> when the hood <NUM> is in position, the covering portion <NUM> has the additional benefit of covering the access point <NUM> of the needleless connector <NUM>, thus reducing or eliminating contact with contaminants.

The infusion set <NUM> may further include one or more filters <NUM>, as shown in <FIG>, is an embodiment which is not part of the invention as defined by the appended claims. The filter <NUM> may have a housing <NUM>, an inlet port <NUM> that connects to an inlet tube <NUM> and an outlet port <NUM> that connects to an outlet tube <NUM>. Fluid may flow through the input tube <NUM> into the input port <NUM>, through filter elements or materials in the housing <NUM>, and out the outlet port <NUM> to the outlet tube <NUM>. An anti-snagging structure guide <NUM> is provided for the filter <NUM>. The guide <NUM> may have a filter connection portion <NUM> that may be integrally formed with the housing <NUM>. The filter connection portion <NUM> may be separately formed and connect to a portion of the housing <NUM>. The guide <NUM> may also have a tail portion <NUM> with a tube connection point <NUM> for tethering the tail portion <NUM> to the input tube <NUM> or the output tube <NUM>. The tail portion <NUM> has a sliding surface <NUM> configured to move the filter <NUM> past a physical object without snagging. As shown in <FIG>, the filter <NUM> may have a guide <NUM> disposed at each end of the housing <NUM>, thus minimizing or preventing snagging of the filter <NUM> when moving in either direction along the longitudinal axis of the filter <NUM>.

Claim 1:
An anti-snagging component (<NUM>, <NUM>, <NUM>, <NUM>) for use in an infusion set, the anti-snagging component comprising:
a covering portion (<NUM>, <NUM>, <NUM>, <NUM>) configured to be received by a needless connector (<NUM>) on a first input end of a Y-site (<NUM>) infusion set component;
a tail portion (<NUM>, <NUM>, <NUM>, <NUM>) configured to be slidingly connected to an input tube (<NUM>) received by a second input end of the Y-site infusion set component; and
a sliding surface (<NUM>, <NUM>, <NUM>, <NUM>) configured to slidingly guide the Y-site infusion set component past an obstruction without snagging when the infusion set is moved,
wherein the covering portion is configured to cover an access point (<NUM>) of the needleless connector when the anti-snagging component is engaged with the Y-site infusion set component and the covering portion is removed from the access point of the needleless connector when the anti-snagging component is disengaged from the Y-site infusion set component.