WO2020142185A1

WO2020142185A1 - Smart tubing connectors for body cavity irrigation systems and coaxial tubing connectors

Info

Publication number: WO2020142185A1
Application number: PCT/US2019/066486
Authority: WO
Inventors: Jerome A. HENRY; Keith H. Gausmann; Gerard P. GRIMES; Brendan J. HENEGHAN; Megan WALL
Original assignee: Hollister Incorporated
Priority date: 2019-01-04
Filing date: 2019-12-16
Publication date: 2020-07-09

Abstract

Ergonomic smart tubing connectors and coaxial tubing connectors that include two discrete fluid communication paths that are connected to the respective lumens of a coaxial tubing connector are disclosed for use with an electromechanical rectal irrigation, stoma irrigation or trans-anal irrigation device. One or more magnets in the smart tubing connectors are detected by Hall Effect sensors to determine the catheter, tubing set and procedure to be indicated and run by the device.

Description

TITLE

Smart Tubing Connectors for Body Cavity Irrigation Systems and Coaxial Tubing Connectors

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent

Application Serial No. 62/788,457, filed January 4, 2019, the disclosure of which is hereby incorporated by reference in its entirety.

FIELD OF THE DISCLOSURE

[0002] The present disclosure is directed to ergonomic smart tubing connectors for body cavity irrigation systems, and coaxial tubing connectors having inlet/outlet ports.

[0003] More particularly, the disclosure provides ergonomic smart tubing connectors for an electromechanical rectal irrigation (Rl) or stoma irrigation (SI) device that has a base unit and a controller, such as is disclosed in International Patent Application PCT/US17/41205. The smart tubing connectors may have a female or male configuration, and the controller may be tethered to the base unit or communicate wirelessly.

BACKGROUND

[0004] Many individuals suffering spinal cord injury (SCI) and other medical conditions (e.g., cauda equina syndrome, multiple sclerosis (MS), spina bifida (SB), and chronic constipation) may need to avail themselves of bowel management treatments, in many cases along with a bladder management program. For SCI users, the issues of independence, dexterity, and ease of use are important needs that must be addressed by a bowel management program. Users can avail themselves of various solutions such as pharmacological (laxatives/suppository), digital stimulation, diet control and others, with the aim of having a regular bowel management routine without constipation or fecal incontinence.

[0005] Rectal irrigation (Rl)/trans-anal irrigation (TAI) provides another option for bowel management. Rl is the delivery of irrigating liquid into the colon to flush the system of stool and create pseudo-continence for the end user. Systems currently on the market allow the user to utilize a product over the toilet, in a commode/shower chair or in a bed to introduce water into the bowel through a rectal catheter. The user will introduce an amount of water into the bowel (typically 500 700 ml_) in order to flush out stool located in the bowel passage. The user will typically introduce the water, wait for a period of time and allow gravity to flush the water and stool out of the body. The rectal catheter may have an

inflatable/deflatable balloon to assist in retention of the catheter during water introduction. The balloon is typically inflated by a fluid such as air or water. Thus, there may be various tubing sets specifically configured for each type of use.

[0006] The typical Rl device has an irrigation liquid reservoir and a pump base unit which contains a pump for pumping water from the reservoir through suitable tubing to the catheter. Rl devices may use water to inflate a balloon of a rectal catheter. The system may have a single-lumen tubing from a reservoir into a controller, and dual-lumen tubing from the controller to the catheter. One of the dual lumens may enable the rectal catheter balloon to be inflated with water and later deflated; while the second lumen may accommodate water transfer from the reservoir into the rectum. The device may provide that when the catheter balloon is deflated, a liquid communication channel is created so that water returning from the deflated balloon travels via the controller into the lumen toward the catheter, i.e. the water from the deflated balloon does not return to the water reservoir. Thus, the fluid tubing set may contain two separate lumens, one for irrigation fluid or irrigant, and one for retention balloon inflation/deflation. With such a device, it is desirable that neither of the tubing lumens ever communicates with the other lumen during a Rl procedure, so there is no fluid communication between the lumens. This is accomplished by the controller.

[0007] By design, all tubing lumens are independent of each other, and there is no condition of the hydraulic control circuit that permits the lumens to

communicate with one other. This ensures that water from the deflated catheter balloon only returns to the water reservoir, and not into the catheter or the lumens in communication with the catheter. Alternatively, the fluid tubing set may contain three separate lumens, one for irrigant, one for waste control valve actuation, and one for retention balloon inflation/deflation. Accordingly, systems may be configured for use with different catheters, whether having a single lumen or a plurality of lumens, such as with a dual lumen or triple lumen catheter.

[0008] Systems also may be configured for use with catheters that are intended for different treatment modalities. For instance, when a balloon catheter is being used with a base unit and controller, the system needs to be primed, the retention balloon is inflated, the irrigant is instilled, and the retention balloon is deflated. By comparison, when a cone catheter is being used with a base unit and controller, the system needs to be primed and then the irrigant is instilled.

Accordingly, there may be modalities that involve use of a cone catheter, or a balloon catheter, where the balloon catheter may be usable, for example, in a procedure conducted over a toilet or in a bed. The variety of tubing sets and modalities, along with difficulties in manipulating prior art connectors can present challenges for users.

SUMMARY

[0009] A smart tubing connector may be provided at the proximal end of a catheter tubing set that advantageously may be used with a system that includes a pump base unit, an irrigation fluid reservoir, an electronic controller, and a connector hub for establishing fluid communication with the smart tubing connector. The connector hub permits the controller in a base unit to detect which variant of tubing set has been connected to the system. This permits the controller, based on recognition of the smart tubing connector, to automatically adjust to the intended modality and to provide the proper operative procedures associated with the respective tubing set.

[00010] Each smart tubing connector may incorporate one or more magnets, for example, one to three magnets, for interaction with a plurality of Hall Effect sensors, for example, up to eight Hall Effect sensors, in a base unit to which the connector may be connected. Examples of the smart tubing connector are disclosed showing both a female connector configuration and a male connector configuration, facilitating more flexibility in designing electromechanical rectal irrigation (Rl) or stoma irrigation (SI) devices. The smart tubing connector also includes an ergonomic design facilitating quick connection and disconnection from such a base unit or other device. The ergonomic design is intended to facilitate use by individuals having limited dexterity. Thus, the smart tubing connector may be incorporated into a trans-anal irrigation device for improved user convenience. [00011] The disclosure further includes a coaxial tubing connector that includes two discrete fluid communication paths that are connected to the respective lumens of a coaxial tubing connector, which enable fluid to enter or exit the connector, and which may be used in tubing sets that feature the smart tubing connector. The separate flow paths of the coaxial tubing connector provide communication with respective inlet/outlet ports.

[00012] In one aspect, the present disclosure provides a smart tubing connector in combination with a socket, including a connector configured for connection to a selected type of catheter having at least one lumen and being configured to be slidably received by the socket, one or more magnets at the proximal end of the connector, with the number of magnets being associated with the selected type of catheter that is connected to the connector, the socket having a plurality of sensors spaced apart and incorporated into the socket in fixed positions, wherein the sensors detect the presence of the one or more magnets when the connector is inserted into the socket. The combination further includes a locking pawl that is forced into a locked position when the connector is inserted into the socket, and a gasket that provides a seal between the at least one lumen of the connector and the socket when the connector is in the locked position within the socket.

[00013] In an additional aspect, the present disclosure provides a rectal irrigation device, including a pump base unit, an irrigation fluid reservoir in fluid communication with the pump base unit, the base unit having a connector hub, a smart tubing connector configured to be slidably inserted into a socket in the connector hub, a tubing set having at least one lumen and including a selected type of rectal catheter at a distal end and being connected to the smart tubing connector at a proximal end, the smart tubing connector further including one or more magnets, with the number of magnets being associated with the selected type of rectal catheter, and the socket of the connector hub having a plurality of sensors spaced apart and incorporated into the socket in fixed positions, wherein the sensors detect the presence of the one or more magnets when the smart tubing connector is inserted into the socket. The device further includes a locking pawl that is forced into a locked position when the smart tubing connector is inserted into the socket, and a gasket that provides a seal between the smart tubing connector and the socket when the connector is in the locked position within the socket.

[00014] In a further aspect, the present disclosure provides a coaxial tubing connector including an inner lumen and a concentric outer lumen, and the connector having a first end with the inner lumen having an inlet/outlet and the outer lumen having an inlet/outlet, and the connector having a second end with the inner lumen having an inlet/outlet and the outer lumen having an inlet/outlet. The inner lumen has a first flow path extending between the inlet/outlet of the inner lumen at the first end of the connector and the inlet/outlet of the inner lumen at the second end of the connector, and the outer lumen has a first flow path extending between the inlet/outlet of the outer lumen at the first end of the connector and the inlet/outlet of the outer lumen at the second end of the connector. The connector further includes a first tubing portion in fluid communication with and extending at an angle to the first flow path of the inner lumen and having an inlet/outlet spaced from the inner lumen, wherein the first tubing portion provides a second flow path in communication with the inner lumen, and a second tubing portion in fluid communication with and extending at an angle to the first flow path of the outer lumen and having an inlet/outlet spaced from the outer lumen, wherein the second tubing portion provides a second flow path in communication with the outer lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

[00015] In describing the preferred embodiments, reference is made to the accompanying drawing figures wherein like parts have like reference numerals, and wherein:

[00016] Fig. 1 is a simplified view of a Rl system having a pump base unit, an irrigation fluid reservoir, an electronic controller, shown as optionally wireless, and a connector hub in fluid communication with a smart tubing connector of a tubing set.

[00017] Fig. 2a is a cross-sectioned perspective view of the connector hub of the base unit and the smart tubing connector.

[00018] Fig. 2b is a front perspective view of the smart tubing connector shown in Figs. 1 and 2a, and having a female configuration for use with the connector hub which has a male configuration.

[00019] Fig. 2c is a rear perspective view of the smart tubing connector shown in Figs. 1-2b inserted into the connector hub.

[00020] Fig. 2d is a cross-sectioned side view of the smart tubing connector shown in Figs. 1-2c inserted into the connector hub.

[00021] Fig. 2e is a perspective exploded view of the smart tubing connector shown in Figs. 1-2d.

[00022] Fig. 3 is a schematic view of a System Logic Flow Chart utilizing the magnet and Hall Effect sensor arrangement of the smart tubing connector and connector hub shown in Figs. 1 and 2a. [00023] Fig. 4a is a perspective view of an alternative embodiment wherein a smart tubing connector having a male configuration is shown with a connector hub having a female configuration which would be incorporated into a base unit of a system, such as the system shown in Fig. 1.

[00024] Fig. 4b is a cross-sectioned side view of the smart tubing connector inserted into the connector hub shown in Fig. 4a.

[00025] Fig. 4c is a cross-sectioned perspective view of the smart tubing connector inserted into the connector hub shown in Fig. 4a.

[00026] Fig. 4d is an exploded perspective view of the smart tubing connector and connector hub shown in Fig. 4a.

[00027] Fig. 5a is a perspective view of a coaxial tubing connector that includes two discrete fluid communication paths having inlet/outlet ports that may be connected to respective lumens of a coaxial tubing connector.

[00028] Fig. 5b is an end view of the coaxial tubing connector shown in Fig. 5a.

[00029] Fig. 5c is a cross-sectioned end view of the coaxial tubing connector shown in Fig. 5a.

[00030] Fig. 5d is a cross-sectioned perspective view of the coaxial tubing connector shown in Fig. 5a, and indicating the separate fluid communication paths through the connector.

[00031] Fig. 5e is a partially exploded perspective view of the coaxial tubing connector shown in Fig. 5a and further showing connection to tubing portions, such as may be associated with a tubing set of a TAI system.

[00032] It should be understood that the drawings are not to scale. While some mechanical details of the example smart tubing connectors and coaxial tubing connector having inlet/outlet ports, including other plan and section views of the particular components, have not been shown, such details are considered to be within the comprehension of those skilled in the art in light of the present disclosure.

It also should be understood that the present disclosure and claims are not limited to the preferred embodiments illustrated.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[00033] The present disclosure relates to components for use in an

electromechanical irrigation system 10, such as a rectal irrigation (Rl) or stoma irrigation (SI) device. A simplified view of such a system 10 is shown in Fig. 1. The system 10 may include a pump base unit 12, an irrigation fluid reservoir 14, an electronic controller 16. The pump base unit 12 includes a connector hub 18 for establishing fluid communication with a tubing set 20. As shown in Fig. 1 , the tubing set 20 includes a catheter 22 having a smart tubing connector 24 at the proximal end 26 of the catheter 22, and a catheter rectal implement 28 at a distal end 30 of the catheter 22.

[00034] The controller 16 is shown in this example in the form of a separate controller that may communicate wirelessly with the base unit 12. Alternatively, a controller for the system may be directly connected to or tethered by wired connection to the base unit 12.

[00035] As shown in Figs. 1 and 2a, the connector hub 18 of this example is in a side wall 32 of the base unit 12. The connector hub 18 includes an interface 34 having an elastomer that provides a protective insulation layer, protecting a power printed circuit board 36 having a socket 38 that receives a proximal portion 40 of the smart tubing connector 24. The connector hub 18 also includes a male connector portion 42 that engages a female connector portion 44 of the smart tubing connector 24.

[00036] The smart tubing connector 24 includes a housing 46 that may incorporate one or more magnets 48, whose quantity is specific to the variant of the catheter 22 (e.g., cone catheter or balloon catheter) and to the rectal implement 28 that is attached to the distal end 30 of the catheter 22 of the tubing set 20. The catheter 22 of this example includes a coaxial configuration, with a first, central lumen 50 surrounded by a second lumen 52. However, the catheter may be constructed to have a single lumen, coaxial tubing or other multi-lumen tubing.

[00037] The base unit 12 includes a plurality of Hall Effect sensors 54 proximate a forward wall 56 of the socket 38 of the connector hub 18. The sensors 54 are in fixed positions within the base unit 12, spaced apart and concentric to the male connector portion 42. When the smart tubing connector 24 is inserted and connected to a powered-on electromechanical base unit 12 that contains up to eight Hall Effect sensors 54, the sensors 54 of the base unit 12 sense the presence of the magnet(s) 48 in the smart tubing connector 24 and immediately determine which variant of catheter 22 and tubing set 20 is communicating with the base unit 12. The presence of each magnet 48 may activate a single sensor 54 directly opposed to the magnet 48, or may activate a combination of the two adjacent sensors 54 closest to the magnet 48.

[00038] A system logic flow chart 58 is shown, for example in Fig. 3, where insertion of the smart tubing connector 24 and recognition of the associated tubing set is illustrated schematically. For instance, as shown in the system logic flow chart 58, once the user inserts the smart tubing connector 24 into the socket 38 in the base unit 12, the Hall Effect sensors 54 of the base unit 12 sense the presence of the magnet(s) 48 in the smart tubing connector 24. For example, a tubing set configured for a cone catheter may include one magnet 48, while a tubing set configured for a balloon catheter for use over a toilet may include two magnets 48, and a tubing set configured for a balloon catheter for use in a bed may include three magnets 48. The Hall Effect sensors 54 determine how many magnets 48 are present in the smart tubing connector 24, and communicate with the controller 16 to ensure the proper procedure will be performed. Accordingly, upon recognition of the tubing set variant, the base unit 12 will communicate to the controller 16 as to what display should be presented to the operator, so that the Rl or SI procedure is completed in the prescribed safe and correct sequence.

[00039] The smart tubing connector 24 shown in Figs. 1-2e also is

ergonomically designed to address a number of user difficulties and unmet needs associated with tubing connectors of current Rl and SI devices. First, the housing 46 of the smart tubing connector 24 is constructed as a sliding sleeve that includes a large surface area for users with limited dexterity to easily grasp and connect or disconnect the connector 24 and its associated tubing set 20 to and from the base unit 12. Second, the housing 46 has a circular or cylindrical geometry, so that it simply can be pushed into the socket 38 in the base unit 12 at any rotational orientation. The housing 46 alternatively may have a keyed geometry, such as being D-shaped, with a corresponding geometry of the socket 38, so that there is only one insertion orientation. Third, no twisting motion of the smart tubing connector 24 is required to obtain a secure, water-tight seal between the smart tubing connector 24 and the male connector 42 in the base unit 12. Only a simple pushing motion, as will be described further herein, is necessary to insert the smart tubing connector 24 into the socket 38 and to connect it to the base unit 12. Fourth, as will be described further with respect to the present example, the configuration may provide a loud, audible noise to confirm when the connector 24 is properly attached to the socket 38 of the base unit 12. Fifth, the rear portion of the housing 46 includes an enlarged, radially outward extending portion 60, and the housing 46 may include a textured outer surface, with these features facilitating use of a low gripping force to retract the housing 46, enabling users with limited dexterity or low energy levels to easily retract and disconnect the connector 24 from the socket 38 of the base unit 12.

[00040] In the first example embodiment shown in Figs. 1-2e, the smart tubing connector 24 is of a female connector configuration, having components including the housing 46 that is formed as a sliding sleeve (having two molded halves, shown in Fig. 2e, joined by adhesive, welding or the like), one or more magnets 48, a tube locking pawl 62, a gasket 64 (constructed of a suitable pliable material, such as rubber), and the female connector portion 44. The housing 46 includes a rear aperture 68 that opens to a first cylindrical bore portion 70. The proximal end 26 of the catheter 22 extends through the aperture 68 and is connected to the female connector portion 44 within the first cylindrical bore portion 70. The housing 46 also has a second cylindrical bore portion 72 which is forward of and having a smaller diameter than the first cylindrical bore portion 70. The second cylindrical bore portion 72 slidably receives the female connector portion 44, and has a radially inward extending flange 74 near the forward end of the second cylindrical bore portion 72, having a rear face 76. The housing 46 further includes a tapered bore portion 78 forward of the flange 74 and a front aperture 80 through which the smart tubing connector 24 receives the male connector portion 42 of the connector hub 18 in the base 12. [00041] The female connector portion 44 includes a rear tubing connection portion 82 that receives the proximal end 26 of the catheter 22. The female connector portion 44 also includes a first radially outward extending flange 84 having a front face 86 that abuts the rear face 76 of the radially inward extending flange 74, and a second radially outward extending flange 88 having a rear face 90 that engages a front face 92 of the flange 74.

[00042] The female connector portion 44 is tapered at its proximal end 94 for clearance relative to the tapered bore portion 78 of the housing 46, and has a central bore 96 that receives the gasket 64. The female connector portion 44 also includes a slot 100 that is perpendicular to the central bore 96. The slot 100 receives a locking pawl 62. The locking pawl 62 includes a body portion 102 having a bore 104 therethrough which is configured to receive the front of the male connector portion 42 of the base unit 12. The locking pawl 62 also includes a tapered wall 106 at a first end of the body 102 and a spring arm 108 at an opposed second end of the body 102, which biases the locking pawl 62 to locking position. The spring arm 108 and opposed tapered wall 106 of the locking pawl 62 bias the housing 46 rearward relative to the female connector portion 44 to a rearmost position at rest, when the rear face 90 of the second flange 88 engages the front face 92 of the flange 74.

[00043] When the smart tubing connector 24 is inserted into the connector hub 18 of the base unit 12, a distal protruding concentric surface 110 of the male connector portion 42 is inserted into the central bore 96 of the female connector portion 44, while a proximal protruding concentric surface 112 on the male connector portion 42 engages the body 102 of the locking pawl 62. This activates the locking pawl 62 as the smart tubing connector 46 is inserted into the connector hub 18 by moving the body 102 of the locking pawl 62 within the slot 100 until the body 102 passes over the proximal protruding concentric surface 112 and is biased by the spring arm 108 to move the locking pawl 62 into a locking recess 114 in the male connector portion 42. This secures the male connector portion 42 in place and may emit a loud sound as the locking pawl 62 snaps into the locking recess 114, providing audible confirmation of the locked connection. It also enables the magnet(s) 48 within the proximal portion 40 of the smart tubing connector 24 to communicate with the Hall Effect sensors 54 in the connector hub 18 of the base unit 12 as to which variant of tubing set 20 has been connected. In the example shown, it also causes the distal protruding concentric surface 110 to be pressed against the gasket 64 as a proximal concentric protruding surface 112 is pressed against the gasket 64, thereby forming a fluid tight seal and establishing a dual fluid

communication path to permit fluid to freely pass through the male connector portion 42 into the female connector portion 44, and vice-versa.

[00044] It will be appreciated that when the user wishes to disconnect the smart tubing connector 24 from the base unit 12, the housing 46 is gripped and retracted away from the base unit 12, such as by moving the housing 46 rearward

approximately five millimeters. As the housing 46 slides relative to the female connector portion 44, the tapered bore 78 of the housing engages the tapered end 106 of the locking pawl 62 and forces the body 102 of the locking pawl 62 to slide within the slot 100 in the female connector portion 44. This compresses the spring arm 108 and releases the body 102 of the locking pawl 62 from the locking recess 114 in the male connector portion 42, so as to permit removal of the smart tubing connector 24 from the connector hub 18 of the base unit 12 or an alternative device.

[00045] A second example embodiment, shown in Figs. 4a-4d, includes a second example smart tubing connector 224 that is configured to be connected to and disconnected from a connector hub 218. The connector hub 218 may be integrally formed with or otherwise associated with a pump base unit, such as for a system of the type shown in Fig. 1.

[00046] The smart tubing connector 224 includes a male connector portion 226 having a distal end 228 that may be connected to the proximal end 26 of the catheter 22 of the tubing set 20, or an alternative tubing set of the types previously discussed. As in the prior example, the catheter 22 of this example includes a coaxial configuration, with a first, central lumen 50 surrounded by a second lumen 52, although it will be appreciated that alternative single or multi-lumen catheter configurations may be used.

[00047] The male connector portion 226 also has a proximal portion 230 that may incorporate one or more magnets 232, whose quantity is specific to the variant of the catheter 22, as in the prior example. The proximal portion 230 of the male connector portion 226 also includes a proximal protruding concentric surface 234, and a distal protruding concentric surface 236 immediately forward of a locking recess 238.

[00048] The connector hub 218 includes a housing 240 with a distal end 242 having an aperture 244 of a distal central bore 246 that is concentric with a relatively smaller proximal central bore 248. The central bores 246, 248 receive a gasket 250 (constructed of a suitable material similar to that of the first example embodiment). The housing 240 includes a first flow path 254 in fluid communication with the distal central bore 246, and a second flow path 256 in fluid communication with the small proximal central bore 248, and these structures together form a female connector portion 258. [00049] Embedded in the housing 240 is a plurality of Hall Effect sensors 252 that are in fixed positions, spaced apart and concentric to the central bore 246. As with the first example embodiment, there may be up to eight sensors 252 in the housing 240 associated with the base unit. The sensors 252 sense the presence of the magnet(s) 232 in the smart tubing connector 224 and immediately determine which variant of catheter 22 and tubing set 20 is communication with the base unit. As with the first example embodiment of Figs. 1-3, the presence of each magnet 232 may activate a single sensor 252 directly opposed to the magnet 232, or may activate a combination of the two adjacent sensors 252 closest to the magnet 232. The same system logic flow chart 52 in Fig. 3 applies with respect to the second example embodiment to ensure proper recognition of the catheter 22 and tubing set 20, and respective communication with the controller 16 and operation of the system.

[00050] The housing 240 further includes a slot 260 that is perpendicular to the distal central bore 246. The slot 260 receives a locking pawl 262 that includes a body 264 having a bore 266 therethrough which is configured to receive the male connector portion 226. The locking pawl 262 also includes a user engaging or button portion 268 at a first end of the body 264 and a spring arm 270 at an opposed second end of the body 264, which biases the locking pawl 262 to a locking position.

[00051] When the smart tubing connector 224 is inserted into the female connector portion 258 of the connector hub 218 of a base unit, the proximal portion 230 and proximal protruding concentric surface 234 are received by the aperture 244 and distal central bore 246 of the housing 240, and by the bore 266 through the body 264 of the locking pawl 262. The distal protruding concentric surface 236 of the male connector portion 226 engages the body 264 of the locking pawl 262 as it passes through the bore 266 in the locking pawl 262. This activates the locking pawl 262 by moving the body 264 within the slot 260 of the housing 240 until the distal protruding concentric surface 236 passes through the bore 266 in the locking pawl 262 and the spring arm 270 biases the body 264 to move into the locking recess 238. This secures the male connector portion 226 in place and enables the magnet(s) 232 within the proximal portion 230 of the smart tubing connector 224 to communicate with the Hall Effect sensors 252 in the connector hub 218 of the base unit as to which variant of tubing set 20 has been connected. In the example shown, it also establishes a dual fluid communication path to permit fluid to freely pass through the male connector portion 226 into the female connector portion 258, and vice-versa as the proximal protruding concentric surface 234 and distal protruding concentric surface 236 are pressed against the gasket 250 to form a fluid tight seal.

[00052] It will be appreciated that when the user wishes to disconnect the smart tubing connector 224 from the connector hub 218 of the base unit, the user may press the user engaging or button portion 268, such as by moving the body 264 approximately three millimeters. This forces the body 264 to slide within the slot 260 in the housing 240. This compresses the spring arm 270, thereby releasing the body 264 of the locking pawl 262 from the locking recess 238 in the male connector portion 226, so as to permit the user to grip and remove the smart tubing connector 224 from the connector hub 218 of a base unit or an alternative device.

[00053] Accordingly, the second example smart tubing connector 224 shown in Figs. 4a-4d also is ergonomically designed to address a number of user difficulties and unmet needs associated with tubing connectors of current Rl and SI devices. First, the connector 224 is designed to be easy to grasp and simply may be pushed via a sliding motion into the housing 240 of the connector hub 218 to establish a locked connection, while the button portion 268 enables users with limited dexterity or low energy levels to easily retract and disconnect the connector 224 from the socket 244 of the connector hub 218. Second, the male connector portion 226 of smart tubing connector 224 has a circular or cylindrical geometry, so that it can be pushed into the socket 244 in the connector hub 218 at any rotational orientation.

The male connector portion 226 alternatively may have a keyed geometry, such as being D-shaped, with a corresponding geometry of the socket 244, so that there is only one insertion orientation. Third, only a simple pushing motion is necessary, with no twisting motion of the smart tubing connector 224 required to obtain a secure, water-tight seal between the smart tubing connector 224 and the female connector portion 258 of the connector hub 218 of a base unit. Fourth, as with the first example, the configuration of the smart tubing connector 224 of the second example may provide a loud, audible noise to confirm when the connector 224 is properly attached to the socket 244 of the base unit 12 via the locking pawl 262 snapping into the locking recess 238.

[00054] Also disclosed in Figs. 5a-5e is a coaxial tubing connector 300 that may be of particularly beneficial use with the systems of the previously described example embodiments. The coaxial tubing connector 300 includes an inner lumen 302 and a concentric outer lumen 304, with two discrete communication paths connected to each lumen 302, 304. For example, the coaxial tubing connector 300 has a first end 306 having an aperture or inlet/outlet 308 of the inner lumen 302 and an aperture or inlet/outlet 310 of the outer lumen 304. The connector 300 has a second end 312 having an aperture or inlet/outlet 314 of the inner lumen 302 and an aperture or inlet/outlet 316 of the outer lumen 304. Thus, the inner lumen 302 has a first flow path 318 extending between the respective apertures or inlet/outlets 308, 314, and the outer lumen 304 has a first flow path 320 extending between the respective apertures or inlet/outlets 310, 316. In addition, a first tubing portion 322 extends normal to and is in fluid communication with the inner lumen 302, and has an aperture or inlet/outlet 324 spaced from the inner lumen 302. The first tubing portion 322 provides a second flow path 326 in communication with the inner lumen 302. A second tubing portion 328 extends normal to and is in fluid communication with the outer lumen 304, and has an aperture or inlet/outlet 330 spaced from the outer lumen 304. The second tubing portion 328 provides a second flow path 332 in communication with the outer lumen 304. It will be appreciated that each aperture or inlet/outlet enables fluid to enter or exit the connector, and the first and second tubing portions 322, 328 could extend at angles other than normal to the concentric inner and outer lumens 302, 304 shown in this example.

[00055] The two discrete flow paths 318, 326 and additional aperture or inlet/outlet 324 associated with the inner lumen 302, and two discrete flow paths 320, 332 and additional aperture or inlet/outlet 330 associated with the outer lumen 304 advantageously facilitate access via the additional apertures or inlet/outlets 324, 330, such as for connection to a pressure sensor or flowmeter to quantify and monitor such parameters, or for insertion of additional fluid, such as medication, dye or other fluid, or removal of fluid, such as for ease of sampling from either or both lumens. As shown in Fig. 5e, a first coaxial tubing portion 334 may be connected to the first end 306 of the connector 300, a second coaxial tubing portion 336 may be connected to the second end 312 of the connector 300, a first single lumen tubing portion 338 may be connected to the first tubing portion 322, and a second single lumen tubing portion 340 may be connected to the second tubing portion 328. Thus, for example, when employed with the system 10 shown in Fig. 1 , the connector 300 may be placed in-line in the coaxial catheter 22 of the tubing set 20, wherein the first and second tubing portions 322, 328 may be used to monitor selected parameters or insert or remove particular fluids, as desired.

[00056] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention disclosed herein.

Claims

Claims:

1. A smart tubing connector in combination with a socket, comprising:

a connector configured for connection to a selected type of catheter having at least one lumen and being configured to be slidably received by the socket;

one or more magnets at the proximal end of the connector, with the number of magnets being associated with the selected type of catheter that is connected to the connector;

the socket having a plurality of sensors spaced apart and incorporated into the socket in fixed positions;

wherein the sensors detect the presence of the one or more magnets when the connector is inserted into the socket;

a locking pawl that is forced into a locked position when the connector is inserted into the socket; and

a gasket that provides a seal between the at least one lumen of the connector and the socket when the connector is in the locked position within the socket.

2. The smart tubing connector in combination with the socket of claim 1 , wherein the connector further comprises a female connector portion and the socket further comprises a male connector portion that slidably receives the female connector portion of the connector.

3. The smart tubing connector in combination with the socket of claim 2, wherein the gasket seals the female connector portion to the male connector portion when the connector is inserted into the socket.

4. The smart tubing connector in combination with the socket of claim 1 , wherein the connector further comprises a housing that slidably receives a female connector portion.

5. The smart tubing connector in combination with the socket of claim 4, wherein the locking pawl further comprises a spring arm that biases the housing of the connector to move forward relative to the female connector portion.

6. The smart tubing connector in combination with the socket of claim 5, wherein the housing further comprises an inward extending flange and the female connector portion further comprises a proximal outward extending flange that engages the inward extending flange on the housing when the connector is being inserted into the socket.

7. The smart tubing connector in combination with the socket of claim 1 , wherein the locking pawl is slidably received in a slot that is perpendicular to the slidable movement of the female connector portion within the housing of the connector.

8. The smart tubing connector in combination with the socket of claim 7, wherein the locking pawl further comprises a spring arm that biases the locking pawl to be received in a locking recess of the female connector portion.

9. The smart tubing connector in combination with the socket of claim 8, wherein the locking pawl engages a tapered surface within the housing of the connector such that slidable movement of the housing in a distal direction compresses causes the housing to force the locking pawl to slide within the slot and compress the spring arm so as to unlock locking pawl from the locking recess.

10. The smart tubing connector in combination with the socket of claim 1 , wherein the plurality of sensors are Hall Effect sensors.

11. The smart tubing connector in combination with the socket of claim 1 , wherein the plurality of sensors in the socket are located in a front wall of the socket.

12. The smart tubing connector in combination with the socket of claim 1 , wherein the connector further comprises a male connector portion and the socket further comprises a female connector portion that slidably receives the male connector portion of the connector.

13. The smart tubing connector in combination with the socket of claim 12, wherein the gasket seals the male connector portion to the female connector portion when the connector is inserted into the socket.

14. The smart tubing connector in combination with the socket of claim 1 , wherein the locking pawl is slidably received in a slot that is perpendicular to the slidable movement of the male connector portion within the socket.

15. The smart tubing connector in combination with the socket of claim 14, wherein the locking pawl further comprises a spring arm that biases the locking pawl to be received in a locking recess of the male connector portion.

16. The smart tubing connector in combination with the socket of claim 15, wherein the locking pawl is configured to be engaged by a user so as to slide within the slot and compress the spring arm to unlock locking pawl from the locking recess.

17. The smart tubing connector in combination with the socket of claim 1 , wherein the plurality of sensors in the socket are arranged concentric to the magnets in the connector.

18. An irrigation device, comprising:

a pump base unit;

an irrigation fluid reservoir in fluid communication with the pump base unit; the base unit having a connector hub;

a smart tubing connector configured to be slidably inserted into a socket in the connector hub;

a tubing set having at least one lumen and including a selected type of rectal catheter at a distal end and being connected to the smart tubing connector at a proximal end;

the smart tubing connector further comprising one or more magnets, with the number of magnets being associated with the selected type of rectal catheter;

the socket of the connector hub having a plurality of sensors spaced apart and incorporated into the socket in fixed positions;

wherein the sensors detect the presence of the one or more magnets when the smart tubing connector is inserted into the socket;

a locking pawl that is forced into a locked position when the smart tubing connector is inserted into the socket; and

a gasket that provides a seal between the smart tubing connector and the socket when the connector is in the locked position within the socket.

19. The irrigation device of claim 1 , wherein the locking pawl is slidably received in a slot that is perpendicular to the slidable movement of the smart tubing connector within the socket.

20. A coaxial tubing connector comprising:

an inner lumen and a concentric outer lumen;

the connector having a first end with the inner lumen having an inlet/outlet and the outer lumen having an inlet/outlet;

the connector having a second end with the inner lumen having an inlet/outlet and the outer lumen having an inlet/outlet;

the inner lumen having a first flow path extending between the inlet/outlet of the inner lumen at the first end of the connector and the inlet/outlet of the inner lumen at the second end of the connector;

the outer lumen having a first flow path extending between the inlet/outlet of the outer lumen at the first end of the connector and the inlet/outlet of the outer lumen at the second end of the connector; and

the connector further comprising a first tubing portion in fluid communication with and extending at an angle relative to the first flow path of the inner lumen and having an inlet/outlet spaced from the inner lumen, wherein the first tubing portion provides a second flow path in communication with the inner lumen, and a second tubing portion in fluid communication with and extending at an angle relative to the first flow path of the outer lumen and having an inlet/outlet spaced from the outer lumen, wherein the second tubing portion provides a second flow path in communication with the outer lumen.