Patent Description:
The present disclosure relates generally to body fluid transferring apparatus, and particularly to shunts and shunting devices and methods for their use in transferring blood from the arterial system to the venous system of a patient.

Contemporary devices for bodily fluid transfer, including blood, include shunts. In the case of blood, shunts typically serve to transfer blood from the arterial system to the venous system of a patient.

<CIT> describes a tubing connector having a body that has a first end having a first opening and a second end having a second opening. A passageway extends through the body between the first opening and the second opening. A side opening includes a first side wall, an opposing second side wall and a latch catch disposed between the first and second side walls, and extends from the passageway through the body as a breach opening. The connector also has a clamping member, having a first clamping end that is hingedly connected to the body and a second clamping end that is adapted to releasably engage the latch catch. A clamp portion is disposed between the first clamping end and the second clamping end, and protrudes into passageway to compress closed a tubing, such as a catheter lumen, extending through the tubing connector, when the clamping member is in the closed position, and is releasable from the latch catch and disengages from the catheter.

<CIT> describes a valve assembly for sealing a through passage of a catheter introducing device, comprising a sealing unit having a movable closing member connected to a biasing means, and a seat member arranged with a sealing surface around the aperture of the through passage, wherein the biasing means is arranged to urge the closing member to sealably abut against the sealing surface, corresponding to a closed position, so as to prevent flow of fluid through the valve.

<CIT> describes a blood flow reversal valve which includes a first member having a first passage and a second passage, and a second member having a first passage and a second passage. The first and second members are rotatably fixed relative to one another such that the first passage of the first member is aligned with the first passage of the second member and the second passage of the first member is aligned with the second passage of the second member. A flow directing element is disposed in the cavity and is moveable relative to the first and second members between a first position in which the first passage of the first member and the first passage of the second member are fluidly connected and a second position in which the first passage of the first member and the second passage of the second member are fluidly connected.

The present invention is featured in the appended claims. The disclosed devices and systems provide for shunting blood from the arterial to the venous side of a patient's circulatory system, allowing clinicians to perform operations, while minimizing the obstruction or impedance of blood flow, without impairing the patient's health. For example, the disclosed devices and system are used to assist in the treatment of medical conditions in humans or animals, for example, insertion of a stent into the carotid artery and other, endarterectomy, and neurovascular procedures.

The disclosed devices and systems include a two component housing- a first housing component or trigger housing, for component receiving arterial side tubing (also known as arterial tubing), which connects to an artery of the patient, and, a second housing component, which serves as a blood reservoir for receiving the blood which passed through the first housing component. The second housing component and holds the blood, in order to stabilize delivery pressure of the blood, prior to the blood leaving the reservoir through venous side tubing (also known as venous tubing), through which blood returns to the circulatory system through a vein.

The arterial side tubing extends through the first housing component. An adjustable trigger, also known as a regulator, extends into the first housing component and contacts the arterial tubing, depressing the arterial tubing at various depths, to control the shape (e.g., diameter) of the lumen of the arterial tubing, and therefore, adjust the rate of blood flow (regulate the rate of blood flow) through the arterial tubing. A second housing component, or reservoir housing, joins to the first housing component, and includes a reservoir, for the blood entering from the arterial side tubing. Venous side tubing extends from the second housing component, through which blood flows from the reservoir to the vein of the patient.

A blood filter extends into the reservoir and aligns with the arterial tubing, such that all blood entering the reservoir is subjected to filtration. The filter is easily accessible and removable from the device (housing), as it is held by a snap fit by a connector disc, which serves as a capture mechanism or holder for the filter. The connector disc is in turn, held in place in the first housing component by a compression or press fit with the second housing component, when the second housing component is joined to the first housing component. The first and second housing components are easily separable from each other as they are joined by a friction fit, for example, a press fit, such that a portion of the proximal end of the second housing component is received in a portion of the distal end of the first housing component by a friction fit including a press fit. A connector ring maintains the press fit of the second housing component in the first housing component (and also prevents the second housing component from moving distally) and attaches to the first housing component by a frictional engagement, including a threaded engagement with the first housing component.

The disclosure is directed to a shunt. The shunt comprises: a first housing configured for receiving a first conduit for blood ingress, the first conduit for extending in the first housing; a regulator extending into the first housing for communicating with the first conduit to control blood flow rate through the first conduit; and, a second housing removably attachable to the first housing, the second housing comprising a cavity for receiving and holding blood from the first conduit, and configured for receiving a second conduit, such that the second conduit is in communication with the cavity for blood egress through the second conduit.

The shunt is such that it additionally comprises: a blood filter extending at least partially into the cavity of the second housing, the blood filter in the second housing for communication with the first conduit in the first housing.

Optionally, the shunt is such that it additionally comprises: a connector, for example, a connector ring, for joining the first housing to the second housing so that the second housing is removably attachable to the first housing.

Optionally, the shunt is such that the first housing and the connector form a threaded connection, such that the first housing and second housing are removably attachable to each other.

Optionally, the shunt is such that the regulator is adjustable between a plurality of positions, each position corresponding to a rate of blood flow through the first conduit.

Optionally, the shunt is such that the regulator includes a trigger lever, the trigger lever being movably mounted in the first housing.

Optionally, the shunt is such that it additionally comprises the first conduit extending through the first housing for blood ingress into the first housing.

Optionally, the shunt is such that it additionally comprises the second conduit in communication with the cavity for blood egress from the cavity of the second housing.

The shunt is such that it additionally comprises a connector disc for seating in the first housing, the connector disc including oppositely disposed first and second sides, and including an aperture extending between the first and second sides, the connector disc for connecting with the first conduit on the first side, and the blood filter on the second side, whereby the first conduit communicates with the blood filter via the aperture to form a path for blood flow through the shunt.

Optionally, the shunt is such that the connector disc includes a conduit connector extending from the first side in line with the aperture, for connecting with the first conduit in at least a friction fit, and, a plurality of outwardly extending and circumferentially arranged fingers about the aperture, such that the fingers for receiving the blood filter in at least a snap fit, whereby the first conduit, the conduit connector, the aperture and the blood filter are aligned to form the path for blood flow through the shunt.

Optionally, the shunt is such that it additionally comprises a plurality of protrusions extending into an inner cavity of the first housing for receiving the connector disc to seat in the first housing, and when the first housing is removably attached to the second housing, the connector disc in held in the first housing by a press fit between the plurality of protrusions and a portion of the second housing which extends into the first housing.

The disclosure is further directed to a method for assembling a medical device. The method comprises: providing a shunt comprising: a first housing configured for receiving a first conduit for blood ingress; a regulator extending into the first housing for communicating with the first conduit to control blood flow rate through the first conduit; and, a second housing removably attachable to the first housing, the second housing comprising a cavity for receiving and holding blood from the first conduit, and configured for receiving a second conduit; a blood filter extending at least partially into the cavity of the second housing for communication with the first conduit in the first housing; and a connector disc for seating in the first housing, the connector disc including oppositely disposed first and second sides, and including an aperture extending between the first and second sides, the connector disc being for connecting with the first conduit on the first side and the blood filter on the second side, whereby the first conduit communicates with the blood filter via the aperture to form a path for blood flow through the shunt. The first conduit is attached (e.g., joined or coupled) to the shunt at the first housing; and, a second conduit is attached (e.g., joined or coupled) to the shunt at the second housing; whereby the first conduit and the second conduit are in communication with each other via the shunt.

Generally described herein (not falling under the claimed invention) is also a method for blood transfer in a mammalian patient. The method comprises: providing a shunt comprising: a first housing configured for receiving a first conduit for blood ingress; a regulator extending into the first housing for communicating with the first conduit to control blood flow rate through the first conduit; and, a second housing removably attachable from the first housing, the second housing comprising a cavity for receiving and holding blood from the first conduit, and configured for receiving a second conduit. A first conduit is attached to the shunt at the first housing, and a second conduit is attached to the shunt at the second housing. The first conduit is placed in communication with the mammalian patient at a first location on the mammalian patient; and, the second conduit is placed in communication with the mammalian patient at a second location on the mammalian patent; such that a blood flow pathway is established between the first conduit and the second conduit, via the shunt.

Optionally, the method is such that the first location comprises an arterial portion of a circulatory system of the mammalian patient, and the second location comprises a venous portion of the circulatory system of the mammalian patient, and the blood flow pathway is from the first conduit to the second conduit, via the shunt.

Optionally, the method additionally comprises: regulating the blood flow along the blood flow pathway by placing the regulator into contact with the first conduit at a location along the first conduit and depressing the regulator to cause the first conduit to decrease in size proximate to the location.

Optionally, the method is such that it additionally comprises: regulating the blood flow along the blood flow pathway by releasing the regulator from the depressing contact with the first conduit at the location along the first conduit, to cause the first conduit to increase in size proximate to the location.

Non-limiting examples of embodiments are described below with reference to figures attached hereto that are listed following this paragraph. Identical structures, elements or parts that appear in more than one figure are generally labeled with a same numeral or character in all the figures in which they appear. Dimensions of components and features shown in the figures are chosen for convenience and clarity of presentation and are not necessarily shown to scale.

The shunting of blood by systems which transfer blood from the arterial system to the venous system is typically achieved using the differential pressure between the patient's (e.g., a mammalian patient) arterial and venous circulatory systems. However, sometimes when unimpeded flow is established between the two systems at two vessel entry points, for example, between the carotid artery and the femoral vein, the flow can overwhelm the body's ability to achieve homeostasis in the neuro-vascular system leading to complications during procedures. The present disclosure provides a shunting system or shunt, that compensates for the differential pressure and controls rapid blood flow (e.g., rapid blood flow rate) into a blood reservoir of the device, allowing blood to flow into the venous system, at a rate where homeostasis is maintained.

The present disclosure provides apparatus and systems that temporarily reduce blood flow, e.g., blood flow rate and/or pressure, through a shunting system, from which blood is transferred from the arterial side to the venous side of a patient's circulatory system. This temporary reduction of blood flow rate in the shunting system reduces the risk of coagulation and clogging of fluid pathways.

The present disclosure provides a shunting system, including a device comprising a housing through which blood flow is regulated when passing therethrough, for example, from the arterial side to the venous side of the circulatory system. The housing is easily separable into housing components, the separability providing for access to inner components including a blood filter, which is easily removable from a connector disc, the blood filter and connector disc held in place in the housing when the housing components are coupled.

The device includes a first housing component, or trigger housing, which mechanically couples to a second housing component, or reservoir housing. The trigger in the trigger housing allows for manual operation of a trigger, which when in operation, controls the rate of blood flow through the trigger housing (and downstream through the reservoir housing and venous side tubing).

The trigger housing may include an adjustable trigger (also known as a regulator), which may be manually controlled, for reducing flow through the housing, as well as an entry portal allowing for the acceptance of arterial side tubing. The trigger housing may have an exit portal to which the distal end of the arterial side tubing (through which blood enters from an arterial access point) may be attached. The reservoir housing includes an internal cavity which serves as a blood reservoir, and receives blood from the arterial side tubing in the trigger housing, through an inflow portal. The blood reservoir also includes and outflow portal, to which venous side tubing is attached, so that the arterial side blood reenters the body therethrough the venous side of the circulatory system. A blood filter extends through the blood reservoir and receives the blood from the inflow portal. The blood filter catches particles including plaque or other debris that may be produced by interventional or other medical procedures, as the shunted blood flows through the filter along its path to the venous side tubing and into the venous system through a venous access point.

The two housing components are mechanically connected by a connector ring, which joins the first and second housing components, and holds them together. The first and second housing components are such that they are joined mechanically by a friction fit, for example, a press fit, such that a portion of the proximal end of the second housing component is received in a portion of the distal end of the first housing component by a friction fit including a press fit. A connector ring maintains the press fit of the second housing component in the first housing component (and also prevents the second housing component from moving distally) and attaches to the first housing component by a frictional engagement, including a threaded engagement with the first housing component. The blood filter is held in the housing by this mechanical connection, as the second housing component press fits the connector ring, against protrusions in the first housing component. The connector ring snap fits to the blood filter. The blood filter extends at least partially into the blood reservoir. The snap fit renders the blood filter easily and quickly accessible and removable (separable) from the connector disc. Both the snap fit of the blood filter to the connector disc, and the press fit of the connector disc by the joined housing components (e.g., sections), as well as the joined housing components, typically do not employ any glues, adhesives, welds, tapes, mechanicals, fasteners, such as screws, nails, rivets. As a result, the housing is easily disassembled, and the connector disc, and the blood filter held thereby, are easily accessible and removable from the device, and easily separable from each other. Moreover, the disclosed device 100a and system <NUM> may be subsequently reassembled to the original configuration, absent any additional fasteners and/or fastening procedures.

The aforementioned mechanical friction fits, for example, snap fits press fits, compression fits, threaded engagements, hold the device and its components together, in a manner such that the holding forces are sufficient to maintain the housing and components therein in mechanically secure engagements, such that any adhesives or fastening techniques, such as gluing or welding, screws, rivets, clips, or the like, are not necessary. This engagement of system components reduces risks of component failure in the system, and making it simple for the user to open the system (e.g., the housing of the system) to inspect and/or remove the blood filter as desired.

For example, the blood filter is easily removable from the housing in an intact manner, allowing for rapid examination of particles in the filter by the clinician. This structure of the disclosed housing avoids problems with blood filters, that are welded and/or glued to housing components, or other internal components used within the housing components, and as such, are prone to mechanical failure. This is because the connector disc and/or the blood filter may dislodge, and impede blood flow during a procedure, which has potentially fatal consequences to the patient.

In some embodiments the system includes a trigger housing with a trigger, that may quickly and easily reduce or regulate blood flow through the system. The trigger housing typically has an input portal that allows acceptance of tubing that may be attached to an arterial vessel access point.

In other embodiments, the trigger housing includes a blood reservoir housing which may have a portal to which venous side tubing is attached, allowing blood to exit from the blood reservoir to a venous access point. The system, for example, includes arterial side tubing, which extends into the trigger housing and communicates with an entry portal or opening of the blood reservoir. The blood reservoir typically has an exit portal to which venous side tubing connects, which in turn, typically attaches to a venous access point.

The trigger housing, for example, contains a trigger lever with a button, which can be depressed in order to cause the trigger lever to engage with, and depress the arterial side tubing that is secured within the trigger housing, thus allowing for temporary reduction of blood flow into the blood reservoir. The trigger lever is also releasable, and coupled with the resilience of the arterial side tubing, disengages in a spring-like manner, to increase blood flow into the blood reservoir, as the arterial side tubing adjusts to widen the lumen size, with the lumen returning to its original size once all pressure is released from the trigger lever.

Throughout this document, references to directions and orientations, such as proximal, distal, inner outer, longitudinal, transverse, inward, outward, inner, outer, upper, lower, front, rear, top, bottom, lateral, upstream, downstream, and derivatives thereof, and the like. The references to these directions and orientations are exemplary, for describing and explaining the present disclosure, and embodiments thereof, and are not limiting in any way.

<FIG> illustrates a system <NUM> which allows shunting of blood from the arterial to the venous side of a patient's circulatory system. The system <NUM> includes a shunt 100a (also known as a device, these terms used interchangeably herein), with a proximal end 100ap and a distal end 100ad, through which a longitudinal axis LA extends. The longitudinal axis LA extends from a proximal end PE to a distal end DE, these "proximal" and "distal" end orientations used herein for reference purposes when describing the system <NUM> and the components thereof.

The shunt 100a, at the proximal end 100ap, attaches to arterial side tubing <NUM>, and at the distal end 100ad of the shunt 100a, to venous side tubing <NUM>. The shunt 100a includes a housing 100a' (or body, these terms used interchangeably herein), formed, for example, of two connectable housing components. These components include a first housing component or trigger housing <NUM>, which attaches to a second housing component or reservoir housing <NUM> (or blood reservoir), as a connector ring <NUM> of the reservoir housing <NUM> threadably engages or screws onto a correspondingly threaded <NUM> flange <NUM> (<FIG>) on the outer surface of the trigger housing <NUM>. The system <NUM> is such that blood is carried from an arterial entry point, or starting point, through the device 100a (from the first housing (component) <NUM> to the second housing (component) <NUM>), to a venous entry point, or finish point, this direction of travel for the blood flow known as "downstream". For example, the trigger housing <NUM>, the connector ring <NUM>, and the reservoir housing <NUM> are symmetric along the longitudinal axis LA.

The arterial-side tubing <NUM> attaches to the patient's arterial entry point (not shown), for blood ingress into the system <NUM>. This tubing <NUM> fits into entry portal <NUM> of the trigger housing <NUM> (e.g., joining or coupling to the trigger housing <NUM>), for example, by a frictional engagement. Venous side tubing <NUM> attaches to the patient's venous entry point (not shown), for blood egress from the system <NUM>. The tubing <NUM> also attaches (e.g., joins or is coupled to) to the exit portal <NUM> of the blood reservoir <NUM>, for example, by a frictional engagement over the exit portal <NUM>.

The trigger housing <NUM> includes an entry portal <NUM> extending outward and allowing a distal end of the arterial side tubing <NUM> to be fitted and passed into the trigger housing <NUM>, so as to extend therethrough, until connecting to a port, formed by a protuberance <NUM>, extending proximally from a connector disc <NUM> (<FIG>), inside the trigger housing <NUM>.

A trigger lever <NUM> (shown in greater detail in <FIG>, <FIG>), also known as a regulator, includes a button <NUM> and an engagement arm <NUM>, from which extends an outwardly protruding tab <NUM>. The trigger lever <NUM> extends out of a slot <NUM>, which is formed in trigger housing <NUM>, at, for example, the upper side (upper portion). The remainder of the trigger level button <NUM> is in the inner cavity <NUM> of the trigger housing <NUM>. A trigger lever pin <NUM>, disposed on each of opposite arms 106a of the trigger level button <NUM>, extends out of oppositely disposed mount holes <NUM> (only one shown) in the trigger housing <NUM>, such that the trigger lever <NUM> is pivotally (rotationally) mounted on the trigger housing <NUM>. This pivotal mounting allows the trigger lever <NUM> to be moved or depressed, for example, manually, to various positions inside and outside of the trigger housing <NUM>, the positions of the trigger lever <NUM> for regulating blood flow through the trigger housing <NUM> and downstream therefrom.

Turning also to <FIG>, there are shown exploded views of the system <NUM>. The trigger housing <NUM> includes an entry portal <NUM>, a slot <NUM> in the upper proximal surface, and an inner cavity <NUM>. The trigger housing <NUM> terminates in a distal rim 103x at the distal edge 103x' of the housing <NUM>. The threaded flange <NUM> extends proximally, from the distal edge 103x' to a ring stop <NUM>, which is of a larger diameter than the connector ring <NUM>, to serve as a travel limit for proximal movement of the connector ring <NUM>, when the trigger housing <NUM> and the blood reservoir <NUM> are joined together.

The arterial side tubing <NUM> extends into the entry portal <NUM> of the trigger housing <NUM>, where it connects to a protuberance <NUM> of the connector disc <NUM> (shown in detail in <FIG> and <FIG>). The protuberance <NUM> includes an outer surface <NUM> that slopes distally upward and away from its proximal edge. The connection is such that the arterial side tubing <NUM> inner walls 101a typically engage the protuberance <NUM> by extending over a circumferential ledge 140a, to form a secure attachment, as shown in <FIG>.

The arterial side tubing <NUM> is received in an acceptance channel <NUM> along surfaces 110a which are formed on the bottom or lower side of the inner cavity <NUM> of the trigger housing <NUM>, as shown in <FIG>. The surfaces 110a are shaped to fit snugly around the bottom and sides of the outside diameter of a portion of the arterial side tubing <NUM>, to hold the arterial side tubing <NUM> in place. For example, the sides and bottom of the distal bottom surface 110a of acceptance channel <NUM> of the trigger housing <NUM> are round, such as in a tube shape, so as to form the acceptance channel <NUM>. The acceptance channel <NUM> surfaces 110a, for example, mirror the shape of the arterial side tubing <NUM>, while snugly fitting the arterial side tubing <NUM>, for example, along an arc of approximately between <NUM> degrees to <NUM> degrees (e.g., leaving the top circumference of the arterial side tubing <NUM> not in contact with the acceptance channel surface <NUM>).

Moving distally (toward the distal end DE) along the longitudinal axis LA, a connector disc <NUM>, for seating in the trigger housing <NUM>, is shown in detail in <FIG>. The connector disc <NUM>, is, for example, circular in cross section, so as to fit within the inner cavity <NUM> of the trigger housing <NUM>, by seating against protrusions <NUM> extending inward into the cavity <NUM>. The connector disc <NUM> includes an internal base or plate 117a, and an outer cylinder 117b, which, for example, is tapered outward proximally (toward the proximal end PE of the longitudinal axis LA) to an outer platform 117c. The outer platform 117c, along its circumferential edge <NUM>, includes, for example, two first segments 150a between second 150b segments, the first 150a and second 150b segments extending along arc lengths at different elevations. The first segments 150a are formed by grooves which terminate at longitudinally extending surfaces 150a', along the circumferential edge <NUM>.

Turning also to <FIG> and <FIG>, the first segments 150a receive and contact protrusions <NUM>, which are in sets, with the protrusions of each set at the same elevation (extending into the cavity <NUM> to the same distance). The protrusion <NUM> sets are arranged to extend along an arc length, which is slightly less that the arc length (span) of the grooves, which form the first segments 150a, to fit within the respective groove of each first segment 150a. There is an open area <NUM> between each protrusion set. For example, the protrusion sets are oppositely disposed from each other, as are the open areas <NUM> between the protraction sets.

The protrusions <NUM>, for example, are formed in sets and extend circumferentially around the inner distal surface <NUM>, proximate to the location of the flange <NUM> on the trigger housing <NUM>. The protrusions <NUM> are sized to capture and mate with the first segments 150a of the connector disc <NUM>. For example, the protrusions <NUM> are rectilinear in shape, and, for example, knife shaped. There are, for example, two sets of protrusions, extending an arc length just slightly less than the corresponding arc length of the respective first segment 150a (e.g., groove thereof).

The end protrusions 180x of each protrusion set are positioned to abut or be in close proximity to the longitudinally extending faces 150a' of each first segment 150a, so as to fit within the grooves of the first segments 150a. The end protrusions 180x serve as stop surfaces or rotational travel limits, to prevent the connector disc <NUM> for moving rotationally, such that the connector disc <NUM> seats in the inner cavity <NUM> of the trigger housing <NUM> perpendicular or substantially perpendicular to the longitudinal axis LA. While two protrusion sets with two open areas <NUM> are shown, any number of protrusion sets with corresponding open areas are permissible, provided there are grooves in first segments 150a to accommodate the protrusions <NUM>, so that the connector disc <NUM> seats on the protrusions <NUM> substantially free of rotation and perpendicular or substantially perpendicular to the longitudinal axis in the trigger housing <NUM>.

Moving back to <FIG>, <FIG> and <FIG>, the connector disc <NUM> is such that the protuberance <NUM> extends proximally from the proximal side 117p of the base 117a of the connector disc <NUM>. The protuberance <NUM> extends, for example, through the open area <NUM> between the sets of protrusions <NUM>. In the base 117a, there is an aperture <NUM>, extending through the base 117a, which communicates with the lumen <NUM> (<FIG> and <FIG>) of the protuberance <NUM>, and aligns with the opening 113a in the housing ring <NUM> at the proximal portion of the blood filter <NUM>, so as to create a blood flow pathway between the trigger housing <NUM> and the blood reservoir <NUM>, as shown in detail in <FIG> and <FIG>.

The distal side 117d of the connector disc <NUM> includes circumferentially spaced fingers <NUM> formed and extending outward from its distal surface with indents <NUM> formed in the fingers <NUM>. The indents <NUM> provide additional friction or holding force for the respective fingers <NUM>. The fingers <NUM>, for example, extend distally from the connector disc <NUM> in an inward slope or taper, such that the proximal portion of the fingers <NUM> is of a slightly greater diameter than the housing ring <NUM> of the blood filter, while the distal ends of the fingers are of a diameter slightly less than the outer diameter a housing ring <NUM> of the blood filter <NUM>. This smaller diameter formed by the fingers <NUM> at their distal ends serves to secure the blood filter <NUM> in the connector disc <NUM> (e.g., in abutment or close proximity with the base 117a), in an interference press fit. As the fingers <NUM> are of a resilient material, they behave in a spring-like manner, to frictionally engage and retain the blood filter <NUM> in the aforementioned interference press fit, by via the housing ring <NUM>.

The blood filter <NUM> housing ring <NUM>, includes an opening 113a. A lateral "U" shaped stabilizer <NUM>, extends (e.g., distally) from the housing ring <NUM>. The U-shaped stabilizer <NUM> supports filter weave material 115a. The blood filter <NUM> extends to a length suitable to allow the blood filter <NUM> to seat in the correspondingly shaped inner cavity <NUM> (<FIG>) of the blood reservoir <NUM>.

The filter weave material 115a, for example, is a cross-woven monofilament made of hemo-compatible materials such as nylon or polypropylene. The material 115a is suitable for capturing particles of, for example, approximately <NUM> microns or greater. Other suitable filter weave materials capture particles, for example, of approximately <NUM> microns or greater in size, while still other filter weave materials capture particles, for example, of approximately of <NUM> microns or greater. The filter weave material <NUM> may be attached around the inner circumference of the housing ring <NUM> and attached to the stabilizer <NUM>, forming a tube through which fluid or blood moving through the system <NUM> (e.g. downstream, entering the filter <NUM> at the housing ring <NUM> opening 113x) and traveling through the filter <NUM> to the blood reservoir <NUM>.

Turning also to <FIG>, the blood reservoir <NUM> tapers outwardly in the proximal direction, to an outwardly protruding ring <NUM>, also known as a stop ring. The stop ring <NUM> is of a diameter equal to that of the rim 103x of the trigger housing <NUM>, so as to serve as a travel limit (e.g., stop surface) for the reservoir housing <NUM>, when the reservoir housing is joined to the trigger housing <NUM> (via the connector ring <NUM>). A collar <NUM>, extending proximally from the stop ring <NUM>, and ending in a proximal edge <NUM>, is of a diameter less than the stop ring <NUM>. This dimensioning allows the collar <NUM> to fit between the outer cylinder 117b of the connector ring <NUM> and the inner wall 118a of the inner cavity <NUM> of the trigger housing <NUM>, when the trigger housing <NUM> and the blood reservoir <NUM> are joined together to form the housing 100a' for the shunt 100a. The edge <NUM> of the collar <NUM> abuts or is in close proximity to the platform 117c of the connector disc <NUM>.

An exit portal <NUM> extends from the reservoir housing <NUM>, and is open to the inner cavity <NUM> of the reservoir housing <NUM> via proximally extending finger tubes <NUM>, which are formed on the inside surface of the distal end of blood reservoir <NUM> around a hole 162a. The holes 162a lead into an exit portal <NUM>. The exit portal <NUM> is shaped to receive and hold venous side tubing <NUM>.

The connector ring <NUM> is designed to be moved over the reservoir housing <NUM>, so that the connector ring inner side <NUM> is received on the threaded flange <NUM> of the trigger housing <NUM>, when the trigger housing <NUM> and reservoir housing <NUM> are engaged together. The inner side <NUM>, along its surface, of the connector ring <NUM>, is correspondingly threaded with respect to the threaded flange <NUM>, for creating a mechanically secure frictional connection. The connector ring <NUM> has indents <NUM>, which provide the user a gripping surface. The connector ring <NUM> has its travel in the proximal direction limited by the ring stop <NUM>, which extends circumferentially around the trigger housing <NUM> to a diameter greater than that of the outer diameter of the connector ring <NUM>.

The connector ring <NUM> has inside diameter "V" which is larger than diameter "T" of stop ring <NUM> so that its proximal edge 136a will fit over the stop ring <NUM>. Distances "R" and "T" are, for example, approximately equal, where "T" is the outside diameter of the stop ring <NUM> and "R" is the inside diameter of connector ring <NUM>. For example, the proximal end 136a of connector ring <NUM> is of sized to include sections of various diameters, which are wide enough for the connector ring <NUM> to slide over the stop ring <NUM> (e.g., when the connector ring <NUM> is moving proximally). The distal end 136b is sized to fit flush and engage with the ring stop <NUM>.

<FIG> show the trigger lever <NUM> in detail. The trigger lever <NUM> is, for example, a unitary member, formed of a resilient material such as a polymer, for example, by techniques such as injection molding. The trigger lever <NUM> includes a button <NUM>, which is a main portion or body for the trigger lever <NUM>. The trigger lever <NUM> and button <NUM> are, for example, symmetric about a longitudinal axis LA'. This trigger lever longitudinal axis LA' is, for example, parallel to and coplanar with the Longitudinal axis LA of the device 100a.

The trigger lever <NUM> includes an engagement arm <NUM> with a tab <NUM> formed into its proximal surface, "U" shaped protrusion <NUM>, and engagement pins <NUM>, formed on arms 106a in each of its distal sides. The tab <NUM> protrudes from the arm <NUM> along a proximal surface 109a, and is outwardly tapered in the upward direction, along a surface 109b. The arm <NUM> is such that the resilient material provides it with spring-like behavior. Accordingly, the arm <NUM> can be moved or otherwise flexed or pushed inward (e.g., distally) to disengage the tab <NUM>, along the surface 109a, from abutment with the shoulder 120x (<FIG>) of the slot <NUM> of the trigger housing <NUM>. Additionally, when the arm <NUM> is moved downward, the arm <NUM> will move inward, as the tab <NUM>, along its outer surface 109b, slides along the shoulder 120x of the slot <NUM>, with the arm <NUM> snapping back (moving proximally) into place, once the tab <NUM> has moved sufficiently downward to clear the shoulder 120x of the slot <NUM> (such that upward movement of the trigger lever <NUM> is restricted). The resilient material also allows the pins <NUM> to be snapped into and out of the mount holes <NUM> of the trigger housing <NUM>.

The U-shaped protuberance <NUM>, at the lower portion of the trigger lever <NUM> is used to apply varying amounts of pressure (typically manually applied) to the arterial tubing <NUM>, inside of the trigger housing <NUM>, to change the dimensions of the lumen 101c of the arterial tubing <NUM> (e.g., decreasing the diameter of the tubing <NUM>), for example, including deforming the lumen 101c to a smaller size, to regulate blood flow therethrough (and accordingly, downstream, into the blood filter <NUM>, the reservoir <NUM>, and ultimately, through the venous side tubing <NUM>). For example, the "U" shaped protrusion <NUM> is formed to have a lower surface width "Q" where "Q" is <NUM>% to <NUM>% of the width of the arterial side tubing <NUM>.

The trigger housing <NUM>, connector ring <NUM>, blood reservoir <NUM>, blood filter ring <NUM> and lateral stabilizer <NUM>, and connector disc <NUM>, of the system <NUM>, may be formed, molded or made of suitable materials such as a hard polycarbonate or other suitable plastic. These components are typically formed as unitary members (and optionally with the blood filter ring <NUM> and stabilizer <NUM> formed separately and joined together by adhesives and/or welds) by processes such as injection molding and other polymer molding techniques. The components, including the blood filter <NUM> and trigger lever <NUM>, are fitted with one or more types of friction fits including, for example, snap fits press fits, and/or compression fits, which eliminate the need for gluing or welding, reducing risk of component failure in the system, and making it simple for the user to open the system to inspect or remove the blood filter as desired. The aforementioned components, for example, may be colored, painted, clear or opaque or a combination of these finishes.

Also, for example, the arterial <NUM> and venous <NUM> side tubing may be made of a flexible polymer material such as Tygon Medical/Surgical Tubing S-<NUM>-HL, attached to phlebotomy needles to access the respective arteries and veins.

<FIG> and <FIG> are diagrams detailing blood flow from the arterial tubing <NUM> (in the trigger housing <NUM>), through the connector disc <NUM>, and into the blood filter <NUM> (in the blood reservoir <NUM>).

<FIG> shows the connections between the connector disc <NUM> and the arterial side tubing <NUM> on the proximal side of the connector disc <NUM>, and the blood filter <NUM> on the distal side of the connector disc <NUM>. The aperture <NUM> in the base 117a of the connector disc <NUM> aligns with the lumen <NUM> of the protuberance <NUM> and the inner lumen 101c of the arterial side tubing <NUM>. Fluid (e.g., blood) flow AA is shown moving through the inner lumen 101c of the arterial side tubing <NUM>, through the aperture <NUM> in connector disc <NUM>, and then through the opening 113a of the housing ring <NUM> of the blood filter <NUM>, prior to flowing downstream, into the blood reservoir <NUM> (e.g., the inner cavity <NUM> of blood reservoir <NUM>).

<FIG> is a cross-sectional view of <FIG>. Fluid or blood flow "AA" is shown moving downstream, through the inner lumen 101c of the arterial side tubing <NUM>, into the lumen <NUM> of the protuberance <NUM>, and then through the aperture <NUM> in the base 117a of the connector disc <NUM>. Blood then flows downstream, through the housing ring <NUM> of the blood filter <NUM>, and through the filter mesh 115a of the blood filter <NUM>, and into the blood reservoir <NUM>. The blood flow out of the blood reservoir <NUM> is through the exit portal <NUM> (to which is attached venous side tubing <NUM>, through which the blood is returned to the circulatory system through the venous system.

<FIG> show operation of the trigger lever <NUM> on the arterial tubing <NUM>, which has been received in the trigger housing <NUM>, to control blood flow (e.g., blood flow rate), through the arterial tubing <NUM> and downstream of the arterial tubing <NUM>. In these figures, blood flow is shown in the downstream direction and indicated by "AA". The trigger lever <NUM> is adjustable between a plurality of positions, each position moving the protrusion <NUM>, which applies or releases pressure to/from the arterial tubing <NUM>, to control lumen size/diameter. The lumen size/diameter corresponds to a rate of blood flow through the arterial tubing <NUM>.

In <FIG>, the tab <NUM> of the engagement arm <NUM> of the trigger lever <NUM> is above the shoulder 120x of the trigger housing <NUM>. The lumen 101c of the arterial tubing <NUM> is at its maximum diameter, as the trigger lever <NUM>, via its protrusion <NUM> is not applying pressure on the arterial tubing <NUM>. The inner diameter of the lumen 101c is Q1, which is equal to X.

In <FIG>, the tab <NUM> has been moved below the shoulder 120x, by a force, represented by the arrow M, which may be a manual force, such that the protrusion <NUM> impinges on outer surface 101b of arterial side tubing <NUM>, causing the outer surface 101b to move inward, and for example deform the tube <NUM>, such that the lumen becomes smaller. The diameter of the lumen 101c has been reduced, from "X" to "Q2", such that the rate of blood flow is reduced.

<FIG> is a cross sectional view along line 9C-9C of <FIG>. In this figure, the distance "D" represents the outer diameter of arterial side tubing <NUM> located inside of trigger housing <NUM> where "E" represents the width of the bottom surface of the "U" shaped protuberance <NUM> of trigger lever <NUM>. In some embodiments, length "E" is from <NUM>% to <NUM>% of distance "D". As a result, blood flow (blood flow rate) is regulated by being slowed.

In <FIG>, the trigger lever <NUM> is fully depressed by force, represented by the arrow M (for example, a manual force), fully reducing the diameter of the lumen 101c from "X" to zero, closing or otherwise pinching off the arterial tubing <NUM>. Blood flow through the arterial tubing <NUM> is now stopped.

Although the embodiments described herein mainly address blood transfer by shunting, the methods and systems described herein can also be used in other applications, such as in transfers of other bodily fluids, as well as fluid draining from the body, and fluid infusion into the body.

Claim 1:
A shunt (100a) comprising:
a first housing (<NUM>) configured for receiving a first conduit (<NUM>) for blood ingress, the first conduit (<NUM>) for extending in the first housing (<NUM>);
a regulator (<NUM>) extending into the first housing (<NUM>) for communicating with the first conduit (<NUM>) to control blood flow rate through the first conduit (<NUM>);
a second housing (<NUM>) removably attachable to the first housing (<NUM>), the second housing (<NUM>) comprising a cavity (<NUM>) for receiving and holding blood from the first conduit (<NUM>), and configured for receiving a second conduit (<NUM>), such that the second conduit (<NUM>) is in communication with the cavity (<NUM>) for blood egress through the second conduit (<NUM>);
and characterized by a blood filter (<NUM>) extending at least partially into the cavity (<NUM>) of the second housing (<NUM>) for communication with the first conduit (<NUM>) in the first housing (<NUM>); and
a connector disc (<NUM>) for seating in the first housing (<NUM>), the connector disc (<NUM>) including oppositely disposed first and second sides (117d, 117p), and including an aperture (<NUM>) extending between the first and second sides (117d, 117p), the connector disc (<NUM>) being for connecting with the first conduit (<NUM>) on the first side (117d) and the blood filter (<NUM>) on the second side (117p), whereby the first conduit (<NUM>) communicates with the blood filter (<NUM>) via the aperture (<NUM>) to form a path for blood flow through the shunt (100a).