Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/002—Packages specially adapted therefor ; catheter kit packages
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
  • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
  • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0043—Catheters; Hollow probes characterised by structural features
  • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
  • A61M2025/0046—Coatings for improving slidability
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2210/00—Anatomical parts of the body
  • A61M2210/10—Trunk
  • A61M2210/1078—Urinary tract

Definitions

• Urinary incontinence causes a person to lose control over their bladder resulting in loss of large or small quantities of urine. This can be caused due to multiple reasons.
• a paraplegic or tetraplegic user loses the control of their bladder and they need to empty their bladder using urinary catheters. These can be indwelling (the catheter is placed for a longer duration inside the bladder and attached to a urine bag to collect the urine) or they can be intermittent (the catheter is periodically inserted into the bladder and the urine is drained from it either directly in appropriate drainage area or inside a urine bag). Intermittent catheters are preferred in the cases where the user can self-catheterize or wishes to not be seen with a urine bag. The intermittent catheters allow the user a freedom of mobility.
• a catheter can be pre-lubricated.
• the lubricant can spill while opening the package which can soil or stain the user’s clothing.
• residual urine within the catheter lumen can exit the catheter lumen and soil or stain the user’s clothing.
• urinary catheters include a packaging shape that is not conducive to carry on one’s person, such as within a pocket of clothing.
• the lid when the lid is in the open position, the lid is rotated at least 90 degrees away from the closed position. In some embodiments, when the lid is in the open position, the lid is rotated at least 180 degrees away from the closed position. In some embodiments, the lid is rotatably biased toward the open position via the hinge.
• the lid includes a first protrusion extending away from a circumferential edge of the lid
• the outlet hub includes a corresponding second protrusion extending away from a side wall of the outlet hub, where the corresponding second protrusion is positioned adjacent the hinge.
• An interference between the corresponding second protrusion and the first protrusion defines a detent to maintain the lid in the open position.
• the outlet hub includes a protrusion extending away from a side wall of the outlet hub
• the lid includes a protrusion receiving member disposed on a top side of the lid, where the receiving member is configured to inhibit separation of the protrusion from the protrusion receiving member in the absence of a separating force.
• the protrusion is inserted into the protrusion receiving member to maintain the lid in the open position.
• the lid includes a plug disposed on an underside of the lid, and at least a portion of the plug is disposed within the hub chamber when the lid is in the closed position.
• the plug is formed of an elastomeric material.
• the engagement member includes a plug cap disposed within the hub chamber, where the plug cap includes a fluid flow path extending through the plug cap between an underside of the plug cap and one or more side ports located along a cylindrical side wall of the plug cap.
• the plug cap is positionable between a closed position defining the closed state and an open position defining the open state, where the one or more side ports are disposed within the hub chamber when plug cap is in the closed position such that a side wall of the outlet hub sealably covers the one or more side ports, and where the one or more side ports are disposed proximally beyond the side wall of the outlet hub when the plug cap is in the open position.
• the plug cap is coupled with the outlet hub so as to be tiltable with respect to the outlet hub about an axis of rotation extending laterally through the plug cap and the outlet hub.
• the plug cap is oriented such that a proximal end face of the plug cap is perpendicular to a longitudinal axis of the outlet hub when the plug cap is in the closed position, and the plug cap is tilted such that the proximal end face is rotated away from the perpendicular orientation when the plug cap is in the open position
• the plug cap is longitudinally positionable between the closed position and the open position.
• the outlet hub includes a ring extending circumferentially around an exterior of the hub body, and the ring is operatively coupled between the plug cap and the hub body such that (i) rotation of the ring in one direction with respect to the hub body causes the plug cap to proximally displace from the closed position to the open position, and (ii) rotation of the ring in the opposite direction with respect to the hub body causes the plug cap to distally displace from the open position to the closed position.
• the outlet hub includes a latching mechanism operatively coupled between the plug cap and the hub body, such that the latching mechanism positions the plug cap at the open position when a distally oriented force is (i) manually applied to the plug cap and (ii) released from the plug cap when the plug cap is in the closed position, and [00017] the latching mechanism positions the plug cap at the closed position when the distally oriented force is (i) manually applied to the plug cap and (ii) released from the plug cap when the plug cap is in the open position.
• the method includes providing a catheter having a catheter tube configured for insertion into the patient bladder, where the catheter tube defines a catheter lumen.
• the method further includes transitioning an engagement member of the catheter from a closed state to an open state, where the engagement member is configured to prevent fluid from exiting a proximal end of the catheter lumen in the closed state through an outlet hub coupled with the catheter tube at the proximal end.
• the method further includes: (i) draining a lubricant from the catheter lumen; (ii) inserting the catheter tube into the patient bladder to establish a flow of urine through the catheter lumen, and (iii) transitioning the engagement member from the open state to the closed state.
• the catheter further includes a sheath extending along the catheter tube, where the catheter tube is disposed within a lumen of the sheath, where a portion of the lubricant is disposed within the lumen of the sheath, and where the portion of the lubricant contacts an outer surface of the catheter tube.
• the engagement member includes a lid coupled the outlet hub via a hinge.
• the lid is rotatable between a closed position defining the closed state and an open position defining the open state, where the lid extends across a proximal end of the outlet hub in the closed position, and where the lid is rotated away from the proximal end of the outlet hub in the open position. Transitioning the engagement member from the closed state to the open state includes rotating the lid at least 90 degrees away from the closed position.
• the engagement member includes a plug cap disposed within a chamber of the outlet hub, where the plug cap includes a fluid flow path extending through the plug cap between an underside of the plug cap and one or more side ports located along a cylindrical side wall of the plug cap.
• the plug cap is positionable between a closed position defining the closed state and an open position defining the open state, where the one or more side ports are disposed within the hub chamber when plug cap is in the closed position such that a side wall of the outlet hub sealably covers the one or more side ports, and where the one or more side ports are disposed proximally beyond the side wall of the outlet hub when the plug cap is in the open position.
• transitioning the engagement member from the closed state to the open state includes positioning the plug cap away from the closed position to the open position.
• the plug cap is coupled with outlet hub so as to be tiltable with respect to the outlet hub about an axis of rotation extending laterally through the plug cap and the outlet hub, and the plug cap is oriented such that a proximal end face of the plug cap is perpendicular to a longitudinal axis of the outlet hub when the plug cap is in the closed position.
• transitioning the engagement member from the closed state to the open state includes tilting the plug cap away from the perpendicular orientation.
• the plug cap is longitudinally positionable between the closed position and the open position.
• the outlet hub includes a ring extending circumferentially around an exterior of the hub body, where ring is operatively coupled between the plug cap and the hub body such that rotation of the ring with respect to the hub body causes the plug cap to proximally displace from the closed position to the open position.
• transitioning the engagement member from the closed state to the open state includes rotating the ring.
• the outlet hub includes a latching mechanism operatively coupled between the plug cap and the hub body, where latching mechanism is configured to position the plug cap at the open position when a distally oriented force is (i) manually applied to the plug cap and (ii) released from the plug cap when the plug cap is in the closed position.
• transitioning the engagement member from the closed state to the open state includes (i) applying the distally oriented force to the plug cap and (ii) allowing the latching mechanism to proximally displace the plug from the closed position to the open position.
• FIG. 1 A is an illustration of a urinary catheter in a packaging state, in accordance with some embodiments
• FIG. IB is an illustration of the urinary catheter of FIG. 1 A in an unpackaged state, in accordance with some embodiments;
• FIG. 1C is a detailed illustration of a proximal end portion of the urinary catheter of FIG. 1 A where the cap is in a closed position, in accordance with some embodiments;
• FIG. ID is a detailed illustration of a proximal end portion of the urinary catheter of FIG. 1 A where the cap is in an open position, in accordance with some embodiments;
• FIG. IE is a detailed illustration of the proximal end portion of the urinary catheter of FIGS. 1C-1D where the cap is in a closed position, in accordance with some embodiments;
• FIG. 2A is an illustration of a second embodiment of the outlet hub of the urinary catheter of FIG. 1A, where the cap is in a closed position, in accordance with some embodiments;
• FIG. 2B is an illustration of the outlet hub of FIG. 2A where the cap is in an open position, in accordance with some embodiments;
• FIG. 3A is an illustration of a third embodiment of the outlet hub of the urinary catheter of FIG. 1A, where the cap is in a closed position, in accordance with some embodiments;
• FIG. 3B is an illustration of the outlet hub of FIG. 3 A where the cap is in an open position, in accordance with some embodiments;
• FIG. 4A is an illustration of a fourth embodiment of the outlet hub of the urinary catheter of FIG. 1A, where the cap is in a closed position, in accordance with some embodiments;
• FIG. 4B is an illustration of the outlet hub of FIG. 4A where the cap is in an open position, in accordance with some embodiments;
• FIG. 5A is an illustration of a fifth embodiment of the outlet hub of the urinary catheter of FIG. 1A, where the cap is in a closed position, in accordance with some embodiments;
• FIG. 5B is an illustration of the outlet hub of FIG. 5 A where the cap is in an open position, in accordance with some embodiments;
• FIG. 6A is an illustration of a sixth embodiment of the outlet hub of the urinary catheter of FIG. 1A, where the cap is in a closed position, in accordance with some embodiments;
• FIG. 6B is an illustration of the outlet hub of FIG. 6A where the cap is in an open position, in accordance with some embodiments;
• FIG. 7A is an illustration of a seventh embodiment of the outlet hub of the urinary catheter of FIG. 1A, where the cap is in a closed position, in accordance with some embodiments;
• FIG. 7B is an illustration of the outlet hub of FIG. 7A where the cap is in an open position, in accordance with some embodiments;
• FIG. 8A is an illustration of an eighth embodiment of the outlet hub of the urinary catheter of FIG. 1A, where the cap is in a closed position, in accordance with some embodiments;
• FIG. 8B is an illustration of the outlet hub of FIG. 8A where the cap is in an open position, in accordance with some embodiments.
• proximal portion or a “proximal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient.
• proximal length of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient.
• proximal end of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient.
• the proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.
• a “distal portion” or a “distal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient.
• a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient.
• a “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient.
• FIG. 1 A illustrates a perspective front view of the catheter 100 in a packaging state.
• the catheter 100 may be disposed in the packaging state before use.
• the catheter 100 may be disposed within an outer package 104, such as a bag or pouch, for example.
• the outer package 104 may be resealable.
• the outer package 104 may be configured to (i) sealably contain the catheter 100 before use and (ii) sealably contain the catheter 100 after use.
• the catheter 100 generally includes a catheter tube 110 having a proximal end 111 and a distal end 112.
• the catheter tube 110 may be formed of any suitable thermoplastic material via an extrusion process.
• a catheter lumen 115 extends along the catheter tube 110, where the catheter lumen 115 is sized to facilitate urine flow therethrough from the distal end 112 to the proximal end 111 during use.
• the catheter tube 110 includes an inlet section 113 extending proximally away from the distal end 112 is configured for insertion into and advancement along a urethra of the user to the patient’s bladder. As such, the inlet section 113 defines a length sufficient to extend from the end of a penis to the bladder of the patient.
• an outer surface of the inlet collar 130 may include gripping features 131, such as protrusions, depressions, ribs, or troughs, for example, to enable grasping of the inlet collar 130 during use.
• the inlet collar 130 includes a seal 132 closing off the distal end of the inlet collar 130 in a pre-use packaging state as further described below.
• the seal 132 may include a film 133 sealably coupled with the inlet collar 130, and in some embodiments, the film 133 may include a pull ring 134 to facilitate removal of the film 133 from the inlet collar 130.
• the catheter tube 110 also includes an outlet hub (hub) 150.
• the hub 150 includes gripping features 151 disposed on an outside surface of the hub 150 to enable grasping of the hub 150 during use.
• the 150 defines a hub chamber 155.
• the hub chamber 155 is in fluid communication with the catheter lumen 115, i.e., the hub chamber 155 defines the catheter lumen 115 at the proximal end 111.
• the hub 150 includes an outlet seal 152 at the proximal end of the hub 150.
• the catheter 100 further includes a sheath 120 extending along the catheter tube 110 from the inlet collar 130 to the hub 150.
• the sheath 120 defines a sheath lumen 125 and the catheter tube 110 is disposed within the sheath lumen 125.
• the sheath lumen 125 is in fluid communication with the hub chamber 155, i.e., the sheath lumen 125 extends into the hub chamber 155.
• the sheath 120 (or more specifically a distal end of the sheath 120) is sealably attached to the inlet collar 130 and the sheath 120 is also sealably attached to the hub 150.
• the sheath lumen 125, the catheter lumen 115 and the hub chamber 155 combine to form a closed volume and a lubricant 108 is sealably contained within the closed volume in the packaging state.
• the lubricant 108 is configured to enable sliding displacement of the inlet section 113 along the urethra during use.
• FIG. IB illustrates the catheter 100 in an unpackaged state, i.e., a state where the catheter 100 is removed from the outer package 104, the catheter tube 110 is uncoiled, and the inlet seal 132 and the outlet seal 152 are breached.
• the catheter 100 is oriented so that the lubricant 108 may flow out of the catheter lumen 115 and/or the sheath lumen 125 via the outlet hub 150.
• FIGS. 1C-1E illustrate various detailed views of the outlet hub 150.
• FIG. 1C illustrates the hub 150 with the outlet seal 152 in the closed state.
• the hub 150 includes an engagement member in the form of a cap 160 rotatably coupled with a hub body 153 via a hinge 154 (e.g., a living hinge).
• the cap 160 is rotated into a closed position to define the outlet seal 152 in the closed state.
• FIG. ID illustrates the hub 150 with the outlet seal 152 in a breached state.
• the cap 160 is rotated away from hub body 153 toward an open position of the cap 160 to define an open state of the proximal end 111 of the catheter tube 110, i.e., an open end of the catheter tube lumen 115 via an open proximal end the hub chamber 155.
• a proximal end of the sheath lumen 125 is also open via the open proximal end the hub chamber 155.
• the cap 160 includes a tab (or flange) 163 protruding away from a circumference edge of the cap 160, where the tab 163 is configured to facilitate the application of an opening force by a user.
• the hinge 154 may bias the cap 160 toward the open position. More specifically, the hinge 154 may be configured to apply a rotating force to the cap 160 to (i) rotate the cap 160 toward the open position after the user applies the opening force to the tab 163 to rotate the cap 160 away from the closed position, and/or (ii) maintain the cap 160 in the open position.
• the cap 160 is generally positioned away from urine exiting the catheter tube 110 during use, when the cap 160 is in the open position.
• FIG. IE is a detailed illustration of a proximal portion of the hub 150.
• the cap 160 is disposed in the closed position.
• a portion of the hub body 153 is cut away showing a hub wall 156 of the hub body 153 in cross section.
• the cap 160 includes a cylindrical wall 161 coupled with an end wall 162.
• the end wall 162 and at least a portion of the cylindrical wall 161 are disposed within the hub chamber 155 when the cap 160 is disposed in the closed position.
• the end wall 162 may include an end wall surface 162 A that is flat or convex (i.e., not concave) to inhibit (i) a collection of lubricant 108 across the end wall 162 while draining the lubricant 108 from the catheter 100 and/or (ii) a collection of urine draining the urine from the patient during use.
• the cap 160 may extend over the proximal end of the hub body 153 so that the cylindrical wall 161 and end wall 162 are disposed external the hub chamber 155.
• the outlet seal 152 is defined by engagement of corresponding sealing members of the hub body 153 and the cap 160.
• the cylindrical wall 161 includes an annular rib 152A extending radially outward from the cylindrical wall 161.
• the hub body 153 includes an annular trough 152B extending radially outward from an inside surface of the hub wall 156.
• the annular rib 152A and annular trough 152B define the corresponding sealing members.
• the annular rib 152A and the annular trough 152B are configured to define the outlet seal 152 when the cap 160 is disposed in the closed position.
• the annular rib 152A and annular trough 152B may also define a detent to secure the cap 160 in the closed position in the absence of the opening force applied to the cap 160.
• the hub 150 may include corresponding sealing members other than the annular rib 152 A and annular trough 152B.
• the hub 150 may include any configuration of corresponding sealing members suitable for defining the outlet seal 152.
• the user may remove the film 133 from the inlet collar 130 to breach the inlet seal 132. Removing the film 133 may include pulling on the pull ring 134.
• the user may breach the outlet seal 152 by rotating the cap 160 away from the closed position.
• the user may re-establish the outlet seal 152 by rotating the cap 160 into the closed position.
• FIGS. 2A-2B illustrate another embodiment of an outlet hub (hub) 250 that may be employed with the catheter 100.
• the hub 250 can, in certain respects, resemble components of the hub 150 described in connection with FIGS. 1A-1E. It will be appreciated that all the illustrated embodiments may have analogous features. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to “2.” For instance, the hub chamber is designated as “155” in FIGS. 1A-1E, and a hub chamber is designated as “255” in FIGS. 2A-2B. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the hub 150 and related components shown in FIGS.
• FIGS. 1A-1E may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the hub 250. Any suitable combination of the features, and variations of the same, described with respect to the hub 150 and components illustrated in FIGS. 1A-1E can be employed with the hub 250 and components of FIG. 2A-2B, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter.
• FIG. 2A illustrates a proximal portion of the hub 250 with the outlet seal 252 in the closed state
• FIG. 2B illustrates the proximal portion of the hub 250 with the outlet seal 252 in the breached state
• the hub 250 includes a cap 260 rotatably coupled with a hub body 253 via a hinge 254 (e.g., a living hinge).
• the cap 260 is rotated into a closed position to define the closed state of the outlet seal 252 in FIG. 2A, and the cap 260 is rotated into an open position to define the open state of the outlet seal 252 in FIG. 2B.
• the hub 250 includes a cap retention mechanism to retain the cap 260 in the open position (see FIG 2B).
• the hub body 253 includes a protruding member 272 disposed on a side of the hub body 253.
• the cap 260 includes a receiving member 271 on a top side of the cap 260.
• the receiving member 271 includes a depression configured to receive the protruding member 272.
• the receiving member 271 is positioned on the cap 160 and the protruding member 272 positioned on a side of the hub body 253 so that the receiving member 271 is positioned coincident with the protruding member 272 when the cap 260 is rotated to the open position.
• the receiving member 271 and the protruding member 272 are positioned so that, when the user rotates the cap 260 to the open position, the protruding member 272 is disposed within the receiving member 271.
• the receiving member 271 and the protruding member 272 may be configured to define a detent configured to retain the cap 260 in the open position in the absence of a separating force applied to the cap 260.
• the protruding member 272 may snap into the receiving member 271 when the cap 260 is rotated to the open position.
• the receiving member 271 and the protruding member 272 may be configured to facilitate separation of the receiving member 271 from the protruding member 272 (e.g., via the application of a separating force) to allow the user to rotate the cap 260 away from the open position toward the closed position.
• the receiving member 271 and the protruding member 272 may be consistent with retaining the cap 260 in the open position.
• the cap 260 may include the protruding member 272 and the hub body 253 may include the receiving member 271.
• the user may breach the outlet seal 252 by rotating the cap 260 away from the closed position.
• the user may also rotate the cap 260 to a fully open position and secure the cap 260 to the wall 256 of the hub body 253 by causing the receiving member 271 to engage the protruding member 272.
• the user may re-establish the outlet seal 252 by rotating the cap 260 into the closed position.
• FIGS. 3A-3B illustrate another embodiment of an outlet hub (hub) 350 that may be employed with the catheter 100.
• FIG. 3 A illustrates a proximal portion of the hub 350 with the outlet seal 352 in the closed state
• FIG. 3B illustrates the proximal portion of the hub 350 with the outlet seal 352 in the breached/open state.
• the hub 350 includes a cap 360 rotatably coupled with a hub body 353 via a hinge 354 (e.g., a living hinge).
• the cap 360 is rotated into a closed position to define the closed state of the outlet seal 352 in FIG. 3A, and the cap 360 is rotated into an open position in FIG. 3B, where the cap 360 is rotated an angle 373 away from the closed position.
• the angle 373 may be greater than about 80 degrees, greater than about 90 degrees, greater than about 170 degrees, or about 180 degrees.
• the hub 350 includes a cap retention mechanism to retain the cap 360 in the open position.
• the hub body 353 includes a protruding member 372 disposed on a side of the hub body 353.
• the cap 360 includes a protrusion 371 extending away from circumferential edge of the cap 360 at a location adjacent the hinge 354.
• the hub body 353 also includes a corresponding protrusion 372 extending away from the wall 356 of the hub body 353 at a location adjacent the hinge 354.
• the protrusion 371 and the corresponding protrusion 372 are configured to slidingly interfere with each other when the cap 360 is rotated between the closed position and the open position by the user.
• the user may breach the outlet seal 352 by rotating the cap 360 away from the closed position.
• the user may also rotate the cap 360 to the open position so that the cap 360 is retained in the open position via a cap retention mechanism.
• the user may re-establish the outlet seal 352 by rotating the cap 360 into the closed position.
• FIGS. 4A-4B illustrate another embodiment of an outlet hub (hub) 450 that may be employed with the catheter 100.
• FIG. 4A illustrates a proximal portion of the hub 450 with the outlet seal 452 in the closed state
• FIG. 4B illustrates the proximal portion of the hub 450 with the outlet seal 452 in the breached/open state.
• the hub 450 includes a cap 460 attached to a hub body 453 via a tether 454.
• the cap 460 is disposed in a closed position to define the closed state of the outlet seal 452 in FIG. 4A, and the cap 460 is disposed in an open position in FIG. 4B to define the open state of the outlet seal 452.
• the tether 454 is attached to the cap 460 at a circumferential edge of the cap 460.
• the tether 454 is attached to the hub body 453 at an attachment point 457.
• the attachment point 457 is spaced distally away from a proximal end of the hub body 453 to define a length of 458 of the tether 458.
• the wall 456 of the hub body 453 may include a trough 459, where the trough 459 is configured to receive the tether 454 therein when the cap 460 is disposed in the closed position.
• the cap 460 may extend over the proximal end of the hub body 453 so that the cylindrical wall 461 and end wall 462 are disposed external the hub chamber 455.
• the cap 460 may be configured so that a portion of the cap 460 is disposed within the hub chamber 455 when the cap 460 is disposed in the closed position. More specifically, the cap 460 may be configured so that the end wall 462 and at least a portion of the cylindrical wall 461 are disposed within the hub chamber 455 when the cap 460 is disposed in the closed position.
• the tether 454 may be configured to bias the cap 460 toward the open position. More specifically, the tether 454 may be configured to maintain the cap 460 at a position away from the open proximal end of the hub body 453 when the cap 460 is not disposed in the closed position. Biasing the cap 460 at a position away from the open proximal end of the hub body 453 when the cap 460 is not disposed in the closed position may inhibit contact of the cap 460 with urine draining from the outlet hub 450 during use.
• the user may breach the outlet seal 452 by displacing the cap 460 away from the closed position.
• the user may re-establish the outlet seal 452 by replacing the cap 460 in the closed position.
• FIGS. 5A-5B illustrate another embodiment of an outlet hub (hub) 550 that may be employed with the catheter 100.
• FIG. 5A illustrates a proximal portion of the hub 550 with the outlet seal 552 in the closed state
• FIG. 5B illustrates the proximal portion of the hub 550 with the outlet seal 552 in the breached/open state.
• the hub 550 includes a cap 560 rotatably coupled with a hub body 553 via a hinge 554 (e.g., a living hinge).
• the cap 560 is disposed in a closed position to define the closed state of the outlet seal 552 in FIG. 5A, and the cap 560 is disposed in an open position in FIG. 5B to define the open state of the outlet seal 552.
• the hinge 554 may be configured to bias the cap 560 toward the open position. More specifically, the hinge 554 may be configured to apply a rotating force to the cap 560 to (i) rotate the cap 560 toward the open position after the user applies an opening force to the tab 563 to rotate the cap 560 away from the closed position, and/or (ii) maintain the cap 560 in the open position.
• the hub 550 includes a plug member 564 attached to an underside of the cap 560 such that the plug member 564 is disposed within the chamber 555 when the cap 560 is disposed in the closed position.
• the plug member 564 may be formed of a soft material, such as an elastomeric material, for example.
• the plug member 564 may cover portions of the cap 560 (e.g., pockets, depressions, inside comers, and the like) that may, in the absence of the plug member 564, collect lubricant and/or urine.
• the plug member 564 may engage the hub body 553 (or more specifically an inside surface of the hub body 553) to define (or partially define) the outlet seal 552.
• An underside 564A of the plug member 564 may be flat or convex (i.e., not concave).
• FIGS. 6A-6B illustrate another embodiment of an outlet hub (hub) 650 that may be employed with the catheter 100.
• FIG. 6A illustrates a proximal portion of the hub 650 with the outlet seal 652 in the closed state
• FIG. 6B illustrates the proximal portion of the hub 650 with the outlet seal 652 in the breached/open state.
• the hub 650 includes a cap 660 pivotably coupled with a hub body 653 so as to pivot about an axis of rotation 657, where the axis of rotation 657 passes through the hub body 653 and the cap 660.
• the cap 660 is pivoted to a closed position to define the closed state of the outlet seal 652 in FIG. 6A, and the cap 660 is pivoted to an open position in FIG. 6B to define the open state of the outlet seal 652.
• the cap 660 is generally takes the form of a plug disposed within the hub chamber 655.
• the cap 660 includes a circumferential wall 667 coupled with an end wall 666.
• the end wall 666 is oriented perpendicular to a longitudinal axis 617 of the outlet hub 650.
• the circumferential wall 667 sealably engages the wall 656 of the hub body 653 to define the outlet seal 652.
• the cap 660 defines a fluid flow path 606 extending through the cap 660 from bottom side of the cap to a port 668 extending through the circumferential wall 667.
• the port 668 is positioned so that a hub wall 656 extends across (i.e., covers) the port 668 when the cap 660 is pivoted to the closed position.
• the hub body 653 may include a finger relief 659.
• the finger relief may enable the user to apply the force 605 to pivot the cap 660 from the closed position to the open position.
• Another step may include the user breaching the inlet seal and/or the outlet seal.
• Another step may include draining the lubricant from the lumen of the catheter tube. Draining the lubricant may include transitioning the catheter tube from a looped shape toward an extended shape. Draining the lubricant may also include orienting the catheter tube toward a vertical attitude so that gravity may induce the lubricant to drain from lumen toward the proximal end or the distal end.
• Another step may include re-establishing a seal at the proximal end of the catheter.
• Another step may include replacing the catheter into the outer package.
• Another step may include disposing the catheter in a trash receptacle.

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• Engineering & Computer Science (AREA)
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• Heart & Thoracic Surgery (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Pulmonology (AREA)
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• Ophthalmology & Optometry (AREA)
• Otolaryngology (AREA)
• External Artificial Organs (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

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• 2022
  • 2022-11-21 EP EP22835972.5A patent/EP4615552A1/de active Pending
  • 2022-11-21 JP JP2025529212A patent/JP2025536745A/ja active Pending
  • 2022-11-21 CN CN202280102020.2A patent/CN120225241A/zh active Pending
  • 2022-11-21 WO PCT/US2022/050645 patent/WO2024112323A1/en not_active Ceased

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