Patent Description:
Medical treatments often include the infusion of a medical fluid (e.g., a saline solution or a liquid medication) to patients using an intravenous (IV) catheter that is connected though an arrangement of flexible tubing and fittings, commonly referred to as an "IV set," to a source of fluid, for example, an IV bag. During use, the flow of medical fluid through tubing may be occluded with pinch clamps to control the flow of the medical fluid. Often, pinch clamps are designed for a specific tube size.

Document <CIT> discloses a transfusion speed regulator, a transfusion monitoring system and an operation method of the transfusion monitoring system are disclosed. The transfusion speed regulator includes a housing, a lead rail, an actuator and a regulating roller. The housing includes a bottom plate and the lead rail is assembled on the housing and is not parallel to the bottom plate. The regulating roller is configured to be moved along the lead rail to regulate a transfusion speed, and the actuator is configured to drive the regulating roller to move.

Document <CIT> discloses an endoscope valve including a handle and an insertion tube, adapted for insertion into a patient, connected to the handle. A valve is mounted on the handle, for controlling flow through one or more channels, which valve has at least two stable states. In the stable states the valve does not apply a force to leave the state.

Document <CIT> discloses an intravenous tube occluder which has a bow portion and a linkage portion which act to occlude an intravenous tube to prevent unwanted flow of liquid to a patient. The linkage portion and bow portion are engaged to allow the ends of the linkage portion to rotate within a certain range.

Document <CIT> discloses a tube compressor adapted to be applied to a flexible tube to adjustably control the flow of a fluid therethrough.

In some applications, variations in tube size may hinder the performance of the pinch clamp.

The disclosed subject matter relates to flow stop assemblies. In certain embodiments, a flow stop assembly is disclosed that is configured to control flow through a tubing and comprises a flow stop base, and a pincher. The flow stop base includes a base wall extending from the flow stop base; at least one pincher guard extending from the base wall, wherein the at least one pincher guard is configured to be disposed around the tubing; a tubing guide configured to receive the tubing, wherein the at least one pincher guard and the tubing guide are axially spaced apart and are configured to axially align the tubing through the flow stop base; a pincher recess defined between the base wall, the at least one pincher guard, and the tubing guide; a pincher protrusion disposed within the pincher recess and configured to be adjacent to the tubing, wherein the pincher protrusion extends from the base wall; and a base extension extending away from the pincher recess. The pincher is movable relative to the base extension and comprises a pincher surface, the pincher configured to move between a flow position and an occlusion position, wherein in the flow position the pincher surface is spaced apart from the pincher protrusion and in the occlusion position, the pincher surface is disposed adjacent to the pincher protrusion and is configured to obstruct flow through the tubing.

In certain embodiments, a flow stop assembly is disclosed that comprises a tubing defining a flow path, a flow stop base, and a pincher. The flow stop base includes a base wall extending from the flow stop base; at least one pincher guard extending from the base wall, wherein the at least one pincher guard is configured to be disposed around the tubing; a tubing guide configured to receive the tubing, wherein the at least one pincher guard and the tubing guide are axially spaced apart and are configured to axially align the tubing through the flow stop base; a pincher recess defined between the base wall, the at least one pincher guard, and the tubing guide; a pincher protrusion disposed within the pincher recess and configured to be adjacent to the tubing, wherein the pincher protrusion extends from the base wall; and a base extension extending away from the pincher recess. The pincher is movable relative to the base extension and comprises a pincher surface, the pincher configured to move between a flow position and an occlusion position, wherein in the flow position the pincher surface is spaced apart from the pincher protrusion and in the occlusion position, the pincher surface is disposed adjacent to the pincher protrusion and is configured to obstruct flow through the tubing.

In certain embodiments, a method is disclosed that comprises providing fluid flow through a tubing; actuating a pincher against the tubing to fold the tubing over a pincher protrusion; and obstructing the fluid flow through the tubing.

The disclosed flow stop assembly incorporates a pinching mechanism to fold tubing and occlude fluid flow therethrough. The pincher can be movable to fold the tubing over a pincher protrusion. By folding the tubing, flow within the tubing can be reliably occluded when using a wide variety of tubing sizes.

The detailed description set forth below is intended as a description of various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. In some instances, well-known structures and components may be shown in block diagram form in order to avoid obscuring the concepts of the subject technology. Like components are labeled with identical element numbers for ease of understanding. Reference numbers may have letter suffixes appended to indicate separate instances of a common element while being referred to generically by the same number without a suffix letter.

While the following description is directed to the occlusion of medical fluid during the administration of medical fluid using the disclosed flow stop assembly, it is to be understood that this description is only an example of usage and does not limit the scope of the claims. Various aspects of the disclosed flow stop assembly may be used in any application where it is desirable to control the flow of fluid.

The disclosed flow stop assembly overcomes several challenges discovered with respect to certain conventional clamps. One challenge with certain conventional clamps is that certain conventional clamps are designed to be used with specific tubing sizes. Because variations in tubing sizes may hinder the performance of conventional clamps or require various sizes of conventional clamps, the use of conventional clamps is undesirable.

Therefore, in accordance with the present disclosure, it is advantageous to provide a flow stop assembly as described herein that allows for flow occlusion with a wide variety of tubing sizes. The disclosed flow stop assembly provides a folding mechanism that allows for reliable flow occlusion for a wide variety of tubing sizes.

An example of a flow stop assembly that allows for reliable flow occlusion is now described.

<FIG> is a perspective view of a flow stop assembly <NUM> in a flow position, in accordance with various aspects of the present disclosure. In the depicted example, the flow stop assembly <NUM> controls the flow of fluids such as medical fluids as they are delivered from a fluid source to a patient. As illustrated, medical fluid can be directed through a flow path defined by tubing <NUM>. As can be appreciated, the tubing <NUM> can be of any suitable diameter needed for treatment.

During operation, the occlusion mechanism of the flow stop assembly <NUM> can be actuated to allow for fluid flow to be permitted or occluded by folding the tubing <NUM> to occlude flow therethrough. As illustrated, a portion of the tubing <NUM> passes through the flow stop base <NUM> to allow the flow stop assembly <NUM> to control flow through the tubing <NUM>.

In some embodiments, tubing <NUM> extends through, and is axially aligned and/or retained by a pincher guard <NUM> and a tubing guide <NUM>. In the illustrated embodiment, pincher guards <NUM> extend from a base wall <NUM> on either side of the tubing <NUM>. The base wall <NUM> can extend vertically from the flow stop base <NUM> and include a rib to facilitate coupling with other components. The pincher guards <NUM> can prevent lateral movement of the tubing <NUM> during operation, including during pinching or occlusion operations.

A lower portion of the tubing <NUM> can pass through a tubing guide <NUM> formed in the flow stop base <NUM>. The tubing guide <NUM> can be a cylindrical member configured to receive the tubing <NUM>. The tubing guide <NUM> can be sized to prevent radial movement of the tubing <NUM> while allowing axial movement of the tubing <NUM>. The tubing guide <NUM> and the pincher guard <NUM> can cooperatively axially align the tubing <NUM>. In certain embodiments, the tubing <NUM> can be axially affixed or coupled within the tubing guide <NUM>. As can be appreciated, the tubing guide <NUM> can be spaced apart from the pincher guards <NUM> to define a pincher recess <NUM> wherein the tubing <NUM> extends across the pincher recess <NUM>. Further, the base wall <NUM> can define the pincher recess <NUM> and also prevent or restrict radial movement of the tubing <NUM>.

In a flow position, the flow path defined within the tubing <NUM> is unobstructed to allow the flow of medical fluid. In some embodiments, the pincher surface <NUM> of the pincher <NUM> is spaced apart from the portion of the tubing <NUM> disposed within the pincher recess <NUM>. As illustrated, the pincher <NUM> is rotated away from the tubing <NUM> disposed within the pincher recess <NUM>. As described herein, the pincher <NUM> can rotate on a guide pin <NUM> disposed within a guide slot <NUM> formed within the base extension <NUM> of the flow stop base <NUM>. As illustrated, the base extension <NUM> extends away from the pincher recess <NUM> of the flow stop base <NUM>. The pincher <NUM>, in some instances, can further translate along the guide slot <NUM>. In some embodiments, the geometry of the guide slot <NUM> can determine the range of permitted travel of the pincher <NUM>.

In the depicted example, the pincher <NUM> can be actuated or rotated by a mechanical or planar linkage, such as a three bar linkage or a four bar linkage. As illustrated, the pincher <NUM> can be actuated by rotating or moving the rocker <NUM>. The rocker <NUM> is rotatably coupled to the base extension <NUM> of the flow stop base <NUM>. As illustrated, the rocker <NUM> can rotate about a rocker pivot <NUM> rotatably coupling the rocker <NUM> to the base extension <NUM>. As the rocker <NUM> is rotated, the rocker <NUM> can actuate the pincher <NUM> to rotate and/or translate the pincher <NUM>. In some embodiments, the rocker <NUM> is rotatably coupled to the pincher <NUM> at a pincher link <NUM>. During operation, the rocker <NUM> can be actuated by a clinician to actuate or rotate the pincher <NUM>.

<FIG> is a reverse perspective view of the flow stop assembly <NUM> of <FIG> in the flow position, in accordance with various aspects of the present disclosure. During operation, the rotation of the rocker <NUM> and therefore the pincher <NUM> can be limited to prevent damage to the tubing <NUM> or to the flow stop assembly <NUM>. In the depicted example, the rocker <NUM> can include a clamping limit wall <NUM> that extends from the rocker <NUM> to engage the base extension <NUM> at a rotational limit. For example, the clamping limit wall <NUM> can be configured to engage with the base extension <NUM> at a rotational position of the rocker <NUM> determined to effectively occlude or clamp the tubing <NUM> without damaging the tubing <NUM>. Further, the clamping limit wall <NUM> may provide tactile and/or auditory feedback to the clinician.

<FIG> is a perspective view of a flow stop assembly <NUM> in an occlusion position, in accordance with various aspects of the present disclosure. <FIG> is an elevation view of the flow stop assembly <NUM> of <FIG> in the occlusion position, in accordance with various aspects of the present disclosure. With reference to <FIG> and <FIG>, in an occlusion position or configuration, the flow stop assembly <NUM> can occlude the flow of medical fluid through the tubing <NUM>. Advantageously, the flow stop assembly <NUM> can be utilized to occlude the flow of medical fluid during an infusion procedure or any other suitable procedure.

In the depicted example, the pincher <NUM> is actuated to engage the pincher surface <NUM> against the tubing <NUM> to fold the tubing <NUM> into a folded position <NUM> over the pincher protrusion <NUM> formed within the pincher recess <NUM>. As illustrated, the pincher protrusion <NUM> extends from the base wall <NUM>. By folding or kinking the tubing <NUM> over the pincher protrusion <NUM>, the flow within the tubing <NUM> can be occluded or obstructed to limit or stop fluid flow through the tubing <NUM>.

During operation, to move from a flow position to an occlusion position, the pincher <NUM> is rotated or otherwise actuated into place. As the pincher surface <NUM> engages the tubing <NUM>, the pincher guards <NUM>, base wall <NUM>, and/or the tubing guide <NUM> that define the pincher recess <NUM> prevent undesired radial movement of the tubing <NUM> during engagement.

The rocker <NUM> is rotated to rotate and/or translate the pincher <NUM> into the occlusion position. As illustrated, the rocker <NUM> is rotated to be in line with the base extension <NUM> to rotate the pincher <NUM> toward the pincher recess <NUM> and fold the tubing <NUM> over the pincher protrusion <NUM>. Advantageously, by utilizing the rocker <NUM> or linkage, a clinician can easily fold the tubing <NUM> over the pincher protrusion <NUM> with minimal force.

<FIG> is a perspective view of a flow stop assembly <NUM> in a flow position, in accordance with various aspects of the present disclosure. In the depicted example, the flow stop assembly <NUM> can utilize a translating or sliding pincher <NUM> to fold or occlude the tubing <NUM>.

During operation, the pincher <NUM> can slide from a flow position to an occlusion position. In the occlusion position, the pincher surface <NUM> of the pincher <NUM> can engage with the tubing <NUM> to fold the tubing <NUM> over the pincher protrusion <NUM> as described herein.

In some embodiments, the pincher <NUM> can utilize a linkage to translate the pincher <NUM> from the flow position to the occlusion position. For example, the flow stop assembly <NUM> can utilize a four bar linkage to actuate the pincher <NUM>. In the depicted example, the pincher <NUM> can be constrained to translational movement.

As illustrated, a crank <NUM> and a rocker <NUM> can cooperatively allow for the translation of the pincher <NUM>. In some embodiments, the crank <NUM> is rotatably coupled to the base extension <NUM> of the flow stop base <NUM>. As illustrated, the crank <NUM> can rotate about a crank pivot <NUM> rotatably coupling the crank <NUM> to the base extension <NUM>. As the crank <NUM> is rotated, the crank <NUM> can actuate the rocker <NUM>. In some embodiments, the crank <NUM> can be rotatably coupled to the rocker <NUM> at a rocker link <NUM>. In the depicted example, the rotation of the crank <NUM> can actuate or otherwise rotate the rocker <NUM>. During operation, the cooperative rotation of the crank <NUM> and the rocker <NUM> provides a translation force to the pincher <NUM> to translate the pincher <NUM> as desired.

During operation, the rotation of the crank <NUM> and therefore the translation of the pincher <NUM> can be limited to prevent damage to the tubing <NUM> or to the flow stop assembly <NUM>. In the depicted example, the crank <NUM> can include a clamping limit wall <NUM> that extends from the crank <NUM> to engage the base extension <NUM> at a rotational limit. For example, the clamping limit wall <NUM> can be configured to engage with the base extension <NUM> at a rotational position of the crank <NUM> determined to effectively occlude or clamp the tubing <NUM> without damaging the tubing <NUM>. Further, the clamping limit wall <NUM> may provide tactile and/or auditory feedback to the clinician.

<FIG> is a perspective view of a flow stop assembly <NUM>, in accordance with various aspects of the present disclosure. In the depicted example, the flow stop assembly <NUM> can utilize a rotating cam or pincher <NUM> to fold or occlude the tubing.

During operation, the pincher <NUM> can rotate and/or slide from a flow position to an occlusion position. In the occlusion position, the pincher surface <NUM> of the pincher <NUM> can engage with the tubing (not pictured) to fold the tubing over the pincher protrusion <NUM> as described herein.

In some embodiments, the pincher <NUM> can utilize a cam mechanism to rotate the pincher <NUM> from the flow position to the occlusion position. In the depicted example, the pincher <NUM> can rotate and/or translate.

As illustrated, a crank portion <NUM> of the pincher <NUM> and a rocker <NUM> can cooperatively allow for the translation of the pincher <NUM>. In some embodiments, the crank portion <NUM> rotatably couples the pincher <NUM> to the base extension <NUM> of the flow stop base <NUM>. As illustrated, the crank portion <NUM> can rotate about a crank pivot <NUM> rotatably coupling the pincher <NUM> to the base extension <NUM>. As the crank portion <NUM> is rotated, the pincher <NUM> can actuate the rocker <NUM>. In some embodiments, the pincher <NUM> can have a cam surface disposed opposite to the pincher surface <NUM> that engages with a cam surface of the rocker <NUM> such that the rotation of the pincher <NUM> can actuate or otherwise rotate the rocker <NUM>. During operation, the cooperative rotation of the pincher <NUM> and the rocker <NUM> provides a translation force to the pincher <NUM> to translate the pincher <NUM> as desired.

During operation, the rotation of the crank portion <NUM> and therefore the translation of the pincher <NUM> can be limited to prevent damage to the tubing or to the flow stop assembly <NUM>. In the depicted example, the pincher <NUM> can include a clamping limit wall <NUM> that extends from the crank portion <NUM> to engage the cap <NUM> at a rotational limit. For example, the clamping limit wall <NUM> can be configured to engage with the cap <NUM> at a rotational position of the pincher <NUM> determined to effectively occlude or clamp the tubing without damaging the tubing. Further, the clamping limit wall <NUM> and the cap <NUM> may provide tactile and/or auditory feedback to the clinician.

Optionally, the cap <NUM> can be disposed over the pincher <NUM> and/or the rocker <NUM> to at least partially cover the components of the flow stop assembly <NUM>. In some embodiments, a pincher guard or upper tubing guide <NUM> formed through the cap <NUM> can retain and/or align tubing that passes through the flow stop assembly <NUM>, functioning as a pincher guard as described with respect to other embodiments described herein. As illustrated, the upper tubing guide <NUM> can be a tubular protrusion or cylindrical member that extends axially from the cap <NUM> to form a partial sleeve around the tubing. The upper tubing guide <NUM> can prevent lateral or radial movement of tubing during operation, including during pinching or occlusion operations. The upper tubing guide <NUM> can be sized to prevent radial movement of the tubing while allowing axial movement of the tubing.

<FIG> is a perspective view of a flow stop assembly <NUM>, in accordance with various aspects of the present disclosure. In the depicted example, the flow stop assembly <NUM> can utilize a rotating pincher <NUM> to fold or occlude the tubing.

During operation, the pincher <NUM> can rotate from a flow position to an occlusion position. In the occlusion position, the pincher surface <NUM> of the pincher <NUM> can engage with the tubing (not pictured) to fold the tubing over the pincher protrusion <NUM> as described herein.

In some embodiments, the pincher <NUM> is rotatably coupled to the base extension <NUM> of the flow stop base <NUM>. As illustrated, the pincher <NUM> can rotate about a pivot <NUM> allowing the pincher surface <NUM> to travel along an arc. During operation, the rotation of the pincher <NUM> about the pivot <NUM> can provide a mechanical advantage to the clinician.

During operation, the rotation of the pincher <NUM> can be limited to prevent damage to the tubing or to the flow stop assembly <NUM>. In the depicted example, the pincher <NUM> can include a clamping limit wall <NUM> that extends from the pincher <NUM> to engage the cap <NUM> at a rotational limit. For example, the clamping limit wall <NUM> can be configured to engage with the cap <NUM> at a rotational position of the pincher <NUM> determined to effectively occlude or clamp the tubing without damaging the tubing. Further, the clamping limit wall <NUM> and the cap <NUM> may provide tactile and/or auditory feedback to the clinician.

Optionally, the cap <NUM> can be disposed over the pincher <NUM> to at least partially cover and/or retain the components of the flow stop assembly <NUM>. In some embodiments, a pincher guard or upper tubing guide <NUM> formed through the cap <NUM> can retain and/or align tubing that passes through the flow stop assembly <NUM>, functioning as a pincher guard as described with respect to other embodiments described herein. As illustrated, the upper tubing guide <NUM> can be a tubular protrusion or cylindrical member that extends axially from the cap <NUM> to form a partial sleeve around the tubing. The upper tubing guide <NUM> can prevent lateral or radial movement of tubing during operation, including during pinching or occlusion operations. The upper tubing guide <NUM> can be sized to prevent radial movement of the tubing while allowing axial movement of the tubing.

Optionally, the flow stop assembly <NUM> can include a tubing coupler <NUM> that is retained and aligned within pincher recess <NUM>. During operation, portions of tubing can be fluidly coupled to the tubing coupler <NUM> allowing fluid communication therethrough. As can be appreciated, flow through the tubing coupler <NUM> can be stopped by the pinching or occlusion operation as described herein. Advantageously, by coupling tubing to the tubing coupler, aligning and/or positioning tubing within the flow stop assembly <NUM> can be simplified.

Terms such as "top," "bottom," "front," "rear" and the like if used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

Claim 1:
A flow stop assembly (<NUM>) configured to control flow through a tubing (<NUM>), the flow stop assembly comprising: a flow stop base (<NUM>) comprising: a base wall (<NUM>) extending from the flow stop base; at least one pincher guard (<NUM>), wherein the at least one pincher guard is configured to be disposed around the tubing; a tubing guide (<NUM>) configured to receive the tubing, wherein the at least one pincher guard and the tubing guide are axially spaced apart and are configured to axially align the tubing through the flow stop base; a pincher recess (<NUM>) defined between the base wall, the at least one pincher guard, and the tubing guide; a pincher protrusion (<NUM>) disposed within the pincher recess and configured to be adjacent to the tubing, wherein the pincher protrusion extends from the base wall; and a base extension (<NUM>) extending away from the pincher recess;
a pincher (<NUM>) movable relative to the base extension and comprising a pincher surface (<NUM>), the pincher configured to move between a flow position and an occlusion position, wherein in the flow position the pincher surface is spaced apart from the pincher protrusion and in the occlusion position, the pincher surface is disposed adjacent to the pincher protrusion and is configured to obstruct flow through the tubing; and characterized by a rocker (<NUM>) rotatably coupled to the base extension via a rocker pivot (<NUM>) and to the pincher via a pincher link (<NUM>), wherein rotation of the rocker rotates the pincher.