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Title:
CATHETER PRODUCTS INCLUDING URINARY CATHETER COLLECTION BAGS
Document Type and Number:
WIPO Patent Application WO/2021/076515
Kind Code:
A1
Abstract:
A urinary catheter product comprises a urinary catheter connect to a bag, a connector for connecting the urinary catheter to a bag, and a bag having a port for connection to a urinary catheter.

Inventors:
WINES JAMES P (US)
HENRY JEROME A (US)
BOLAND PATRICK (US)
HEALY PAUL (US)
BIGGINS DAMIEN (US)
FOX PAUL F (US)
CHAMBERS MARK (US)
Application Number:
PCT/US2020/055411
Publication Date:
April 22, 2021
Filing Date:
October 13, 2020
Export Citation:
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Assignee:
HOLLISTER INC (US)
International Classes:
A61F5/44; A61F5/442; A61F5/443; A61F5/453; A61F5/455
Domestic Patent References:
WO1996037254A21996-11-28
Foreign References:
US20060025753A12006-02-02
US5642744A1997-07-01
FR2703593A11994-10-14
US201962914744P2019-10-14
US201962934836P2019-11-13
Attorney, Agent or Firm:
RAYA, Paul M. et al. (US)
Download PDF:
Claims:
CLAIMS

1 . A urinary catheter connector, comprising: a body including a proximal end, a distal end, an outer surface and a lumen extending there through, the proximal end being configured to be located at a distal end of a catheter tube such that the lumen of the body is in fluid communication with a drainage lumen of the catheter tube, the distal end of the body defining an opening for urine drainage and including at least one barb configured for attachment to a collection bag.

2. The connector of claim 1 wherein the at least one barb comprises a plurality of barbs.

3. The connector of any one of claims 1 -2 wherein the at least one barb comprises a first barb and a second barb.

4. The connector of claim 3 wherein the first and second barbs are opposed to each other.

5. The connector of any one of claims 3-4 wherein the body includes a spring mechanism that biases the first and second barbs away from one another.

6. The connector of any one of claims 3-5 wherein the first barb is located on a first arm of the body and the second barb is located on a second arm of the body.

7. The connector of claim 6 wherein the first and second arms are biased away from one another.

8. The connector of any one of claims 1 and 2 wherein the at least one barb extends substantially about a perimeter of the body.

9. The connector of claim 8 wherein the at least one barb is a continuous barb.

10. The connector of claim 9 wherein the at least one barb is a bulb-shaped barb.

11 . The connector of claim 9 wherein the at least one barb is a ball-shaped barb.

12. The connector of any one of claims 1-11 wherein the body includes a selectively removable funnel extension.

13. A urinary catheter product, comprising: a connector including a proximal end, a distal end, an outer surface and a lumen extending there through, the proximal end being configured to be located at a distal end of a catheter tube such that the lumen of the connector is in fluid communication with a drainage lumen of the catheter tube, the distal end of the connector defining an opening for urine drainage and including at least one barb; a bag having a port including a proximal end, a distal end, and a lumen extending there through, the port proximal end being configured to mate with the connector, the port having a rib wherein the rib is configured to engage the barb of the connector so as to detachably secure the connector to the port; and the connector lumen being in fluid communication with the bag, such that the bag is configured to receive fluid from the connector.

14. The catheter product of claim 13 wherein the port is attached and extends into an opening in the bag.

15. The catheter product of claim 13 wherein the port is integral with the bag, and wherein the bag and the port are made from a single unitary construction.

16. The catheter product of claim 14 wherein the bag comprises a first sheet and a second sheet heat sealed about their peripheries, wherein the opening is defined through the heat seal and the portion of the heat seal defining the opening is more rigid than at least a second portion of the heat seal, and wherein the opening defines the port.

17. The catheter product of claim 16 wherein the portion defining the opening is conditioned to be more rigid.

18. The catheter product of any one of claims 13-17 wherein the rib is defined by the distal rim of the port.

19. The catheter product of any one of claims 13-18 wherein at least one of the port or the connector comprises a valve.

20. The catheter product of claim 19 wherein the valve is a non-return valve.

21 . The catheter product of any one of claims 19-20 wherein the valve comprises a duckbill valve.

22. The catheter product of any one of claims 19-20 wherein the valve comprises an umbrella valve.

23. The catheter product of any one of claims 13-22 wherein the at least one barb comprises a plurality of barbs.

24. The catheter product of any one of claims 13-23 wherein the at least one barb comprises a first barb and a second barb.

25. The catheter product of claim 24 wherein the first and second barbs are opposed to each other.

26. The catheter product of any one of claims 24-25 wherein the body includes a spring mechanism that biases the first and second barbs away from one another.

27. The catheter product of any one of claims 24-26 wherein the first barb is located on a first arm of the body and the second barb is located on a second arm of the body.

28. The catheter product of claim 27 wherein the first and second arms are biased away from one another.

29. The catheter product of any one of claims 13 and 23 wherein the at least one barb extends substantially about a perimeter of the body.

30. The catheter product of claim 29 wherein the at least one barb is a continuous barb.

31 . The catheter product of claim 17 wherein the conditioning of the portion defining the opening includes annealing the portion defining the opening.

32. The catheter product of claim 17 wherein the conditioning of the portion defining the opening includes chemically conditioning the portion defining the opening.

33. The catheter product of claim 32 wherein the chemical conditioning includes crosslinking.

34. A urinary catheter collection bag having a port including a proximal end, a distal end, and a lumen extending there through, the port proximal end being configured to receive a connector, the port having a rib wherein the rib is configured to engage the connector, so as to detachably secure the connector to the port and allow the lumen of the port to fluidically communicate with a lumen of the connector.

35. The bag of claim 34 wherein the bag comprises a first sheet and a second sheet heat sealed about their peripheries wherein the port is defined through the heat seal and the portion of the heat seal defining the port is more rigid than at least a second portion of the heat seal. 36. The bag of claim 34 wherein the bag comprises a portion defining the port and a portion defining a container section of the bag, the portion defining the port being conditioned to be more rigid than the portion defining the container section.

37. A method of manufacturing a urinary catheter product, comprising the steps of: sealing a first sheet to a second sheet to form a bag, wherein the bag includes a port section and a container section; and conditioning the port section, such that the port section includes a port that is more rigid than at least the container section of the bag.

38. The method of claim 37 further comprising: incorporating a valve into the port section of the bag.

39. The method of any one of claims 37-38 further comprising: mechanically bonding a catheter funnel to the port section of the bag, such that the funnel may fluidically communicate with the bag.

Description:
CATHETER PRODUCTS INCLUDING URINARY CATHETER COLLECTION BAGS

The present application claims the benefit of and priority to U.S. Provisional Application No. 62/914,744, filed October 14, 2019 and U.S. Provisional Application No. 62/934,836, filed November 13, 2019, which are hereby incorporated herein by reference.

Background Field of the Disclosure

[0001] The present disclosure generally relates to urinary catheter products. More particularly, the present disclosure relates to urinary catheter products that include collection bags.

Description of Related Art

[0002] Catheters are used to treat many different types of medical conditions and typically include an elongated catheter shaft that is inserted into and through a passageway or lumen of the body. Catheters, and in particular intermittent catheters, are commonly used by those who suffer from various abnormalities of the urinary system, such as urinary incontinence. Urinary catheters generally comprise a catheter shaft. The catheter shaft includes a proximal end having a tip that is inserted into and through a user’s urethra. The catheter shaft also includes a distal end that includes a drainage member, which may be a funnel or connector that facilitates drainage of bodily fluids for the catheter shaft. The drainage member may then be connected to a bag via a port. Urine drains from the bladder through the catheter shaft, out of the drainage member and into the bag.

[0003] The current process for attaching an intermittent catheter to a urine collection bag requires the use of glue or a chemical bond activated through a welding process. Both the use of glue and welding can become a bottle neck in the manufacturing process. Additionally, both of these processes are material specific and may not be effective will all of the different possible types of materials that catheters and bags may be made from. Thus, there is a need for improvements in the manner in which catheters and urine collection bags are connected to one another. Summary

[0004] There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described and claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to preclude the use of these aspects separately or the claiming of such aspects separately or in different combinations as set forth in the claims appended hereto.

[0005] In a first aspect, a urinary catheter connector is disclosed. The connector has a body including a proximal end, a distal end, an outer surface and a lumen extending therethrough. The proximal end is configured to be located at a distal end of a catheter tube such that the lumen of the body is in fluid communication with a drainage lumen of the catheter tube. The distal end of the body defines an opening for urine drainage and includes at least one barb configured for attachment to a collection bag.

[0006] In a second aspect, a urinary catheter product is disclosed. The catheter product has a connector including a proximal end, a distal end, an outer surface and a lumen extending therethrough. The proximal end is configured to be located at a distal end of a catheter tube such that the lumen of the connector is in fluid communication with a drainage lumen of the catheter tube. The distal end of the connector defines an opening for urine drainage and includes at least one barb. The urinary catheter product also comprises a bag having a port including a proximal end, a distal end, and a lumen extending therethrough. The port proximal end is configured to receive the distal end of the connector. The port has a rib. The rib is configured to engage the barb of the connector so as to detachably secure the connector to the port. Finally, the connector lumen is in fluid communication with the bag, such that the bag is configured to receive fluid from the connector.

[0007] In a third aspect, a urinary catheter collection bag is disclosed. The urinary catheter collection bag has a port including a proximal end, a distal end, and a lumen extending therethrough. The port proximal end is configured to receive a connector. The port has a rib. The rib is configured to engage the connector, so as to detachably secure the connector to the port and allow the lumen of the port to fluidically communicate with a lumen of the connector.

[0008] In a fourth aspect, a method of manufacturing the urinary catheter product is disclosed. The method comprises the steps of: sealing a first sheet to a second sheet to form a bag, wherein the bag includes a port section and a container section. The method also comprises conditioning the port section, such that the port section includes a port that is more rigid than at least the container section of the bag.

Brief Description of the Drawings [0009] Fig. 1 A is a perspective view of an embodiment of a urinary catheter product, showing a catheter tube connected to a bag;

[0010] Fig. 1 B is a close-up side view of an embodiment of a urinary catheter product, showing the connector attached to the catheter tube and inserted into the bag; [0011] Fig. 2A are elevated cross-sectional views of a connector being connected to a port;

[0012] Fig, 2B is a side cross-sectional view of the connector inserted into the port;

[0013] Fig. 3A is a perspective view of an embodiment of a urinary catheter connector, showing the connector with a continuous barb;

[0014] Fig. 3B is a perspective view of an embodiment of a urinary catheter connector, showing the connector with a barb comprising a plurality of barbs and a spring mechanism;

[0015] Fig. 3C is a side view of the connector shown in Fig. 3B; [0016] Fig. 3D is a perspective view of an embodiment of a urinary catheter connector, showing the connector with a recess;

[0017] Fig. 3E is a side cross-sectional view of an embodiment of a urinary catheter port, showing the port having a shoulder, a rib, and a tapered lead in; [0018] Fig. 3F is a side cross-sectional view of a connector having a recess and the connector being inserted into an embodiment of a port having a shoulder; [0019] Fig. 3G is a side cross-sectional view of an embodiment of a connector having a recess and the connector being inserted into a port having a bulb-shaped rib and a shoulder;

[0020] Fig. 4A is a side view of an embodiment of a urinary catheter collection bag having a port with an umbrella valve shown in a closed position;

[0021] Fig. 4B is a side view of the urinary catheter collection bag of Fig. 4A, showing the valve in an open position;

[0022] Fig. 4C is a side view of an embodiment of a urinary catheter collection bag having a port with a duckbill valve shown in a closed position; [0023] Fig. 4D is a side view of the urinary catheter collection bag of Fig. 4C, showing the valve in an open position;

[0024] Fig. 5 is a perspective view of an embodiment of a connector having a selectively removable funnel extension; and

[0025] Fig. 6 is a close-up cross-sectional view of an embodiment of a urinary catheter bag having an integral port;

[0026] Fig. 7 is a perspective view of an embodiment of a urinary catheter connector, showing the connector with a bulb-shaped barb;

[0027] Fig. 8 is a side cross-sectional view of the connector of Fig. 7 inserted into a port having a recess and a shoulder; [0028] Fig. 9 is a perspective view of an embodiment of a urinary catheter connector, showing the connector with a ball-shaped barb;

[0029] Fig. 10 is a side cross-sectional view of the connector of Fig. 9 inserted into a port having a recess and a shoulder;

[0030] Fig. 11 A is a perspective view of an embodiment of a urinary catheter connector having a recess shown outside of a port having a recess and a double rib;

[0031] Fig. 11 B is a side cross-sectional view of the connector of Fig. 11 A inserted into the port of Fig. 11 A;

[0032] Fig. 11 C is a side cross-sectional view of the connector of Fig. 11 A with a modified barb, inserted into the port of Fig. 11 A; [0033] Fig. 12 is a side cross-sectional view of an embodiment of a urinary catheter connector having a barb inserted into a port having two ribs and two recesses.

Description of the Illustrated Embodiments [0034] The embodiments disclosed herein are for the purpose of providing a description of the present subject matter, and it is understood that the subject matter may be embodied in various other forms and combinations not shown in detail. Therefore, specific embodiments and features disclosed herein are not to be interpreted as limiting the subject matter as defined in the accompanying claims.

[0035] Urinary catheter connector products according to the present disclosure and their individual components may be variously configured without departing from the scope of the present disclosure, but in one embodiment, a urinary catheter connector product is configured as shown in Figure 1.

[0036] Fig. 1 A shows a perspective view of a urinary catheter product 100.

The product 100 includes a urinary catheter 111 and a urine collection bag 116 that are connected to each other. The urinary catheter product 100 includes a connector 110 associated with a distal end 120b of a catheter tube 120 of the urinary catheter 111. Referring to Figs. 1 B and 2A, the connector 100 includes a proximal end 112a, a distal end 112b, an outer surface 113 and a lumen 117 extending therethrough. Referring to Figs. 1 A and 1 B, the proximal end 112a of the connector 110 is configured to be connected to the distal end 120b of the catheter tube 120 so that the lumen 117 (Fig. 2A) of the connector 110 is in fluid communication with a drainage lumen 121 of the catheter tube 120.

[0037] Fig. 1 B shows a close-up view of the urinary catheter product 100. The distal end 112b of the connector 110 defines an opening 119 for urine drainage and includes at least one barb 118. The bag 116 has a port 114. As shown in Fig. 2A and 2B, the port 114 includes a proximal end 114a, a distal end 114b, and a lumen 115 extending therethrough. The port proximal end 114a is configured to receive the distal end 112b of the connector 110. The port 114 has a rib 122 which is configured to engage the barb 118 of the connector 110 so as to detachably secure the connector 110 to the port 114. The connector lumen 117 is in fluid communication with the bag 116 so that the bag 116 is configured to receive fluid from the connector 110.

[0038] In one embodiment the port 114 may be a separate component that is attached to the bag 116 and extends through the material of the bag 116. For example, when the bag 116 is formed from a front sheet and back sheet that are sealed to each about their periphery, the port may be a separate component that extends through a portion of the seal.

[0039] In another embodiment the port 114 may be integral with the bag 116, so that the bag 116 and the port 114 are of a single unitary construction made from the same material. For example, in one embodiment the bag 116 may be formed from a first sheet and a second sheet, that are heat sealed to each other about their peripheries. An opening extends through the heat seal and defines the port 114. The portion of the heat seal defining the opening/port is more rigid than at least a second portion of the heat seal. In one embodiment the portion of the heat seal defining the bag opening/port is conditioned to be more rigid that the remaining portion of the heat seal. The opening/port may be conditioned to be more rigid than the remainder of the bag 116 and the remainder of the heat sealed portion by annealing. In alternative embodiments, the opening/port may be conditioned by chemical conditioning, for example by crosslinking.

[0040] Fig. 2A shows a close up view of the connector 110 being inserted into the port 114 (the connector 110-port 114 interface). Fig. 2A shows the connector 110 at various stages of insertion. From left to right, Fig. 2A shows: the connector 110 positioned outside of the port 114; the connector 110 as it is first inserted into the port so that the barb 118 is proximal to the rib 122; the connector inserted such that the barb 118 and rib 122 are aligned; and the connector 110 fully inserted wherein the barb 118 is positioned distal from the rib 122 such that the connector 110 is detachably secured to the port 114.

[0041] Fig. 2B shows a cross-sectional view of the connector 110-port 114 interface of Fig. 2A. Fig. 2B shows the connector 110 fully inserted wherein the barb 118 is positioned distal from the rib 122 such that the connector 110 is detachably secured to the port 114. The rib 122 may be positioned anywhere along the port 114. In one embodiment, the rib 122 may be defined by the distal rim 114c of the port 114. When the connector 110 is inserted into the port 114, and the barb 118 and rib 122 are connected, a water tight seal is formed. In one embodiment, the port rib 122 has a diameter that is slightly less than the body of the connector 110, such that the inner wall of the port forms a tight fit to the body of the connector when the connector is inserted into the port. In one embodiment, the port rib 122 will have a diameter smaller than the outer diameter of the body of the connector 110, which may be the portion of the body of the connector 110 that is proximal barb 118. In another embodiment, the barb 118 may have an outer diameter that is larger than inner diameter of the portion of inner wall of the port 114 that is distal the rib 122. This tight fit creates a liquid tight seal.

[0042] Figs. 3A-3D show various embodiments of the urinary catheter connector 110 which may by employed to connect the catheter to the urine collection bag. In each of Figs. 3A-3D, the connector 110 comprises a body 212. The body 212 includes a proximal end 212a, a distal end 212b, an outer surface 213, and a lumen extending therethrough 217. The proximal end 212a is configured to be located at a distal end of a catheter tube 120b (as shown in Figs.

1 A-1 B) so that the lumen of the body 217 is in fluid communication with a drainage lumen 121 of the catheter tube 120. The distal end of the body 212b defines an opening for urine drainage and includes at least one barb 218 configured for attachment to a collection bag 116. The at least one barb 218 is configured to engage with the rib 118 of the collection bag 116 so that the connector 110 is detachably connected to the bag 116. The at least one barb 218 may also be configured to engage the rib 118 when the rib 118 is defined by the port 114.

[0043] As shown by Figs. 3A-3D, the barb 218 may extend substantially about the perimeter of the body. In the embodiments shown in Figs. 3A and 3D, the barb 218 is a continuous barb that extends circumferentially around the body 212. In one embodiment, the barb 218 may be a plurality of barbs spaced uniformly or randomly circumferentially about the body 212.

[0044] In the embodiment shown in Figs. 3B and 3C, the barb 218 includes a plurality of barbs: a first barb 218a and a second barb 218b. In the illustrated embodiment, the barbs 218a, 218b are opposed to each other, and may be biased away from one another by a spring mechanism 228. Additionally, as shown in Figs. 3B and 3C, the first barb 218a is located on a first arm 225a of the body 212 and the second barb 218b is located on a second arm 225b of the body 212. The arms 225a, 225b are biased away from one another. In the illustrated embodiment, the arms 225a, 225b are biased away from each other by the elasticity of the material. In other embodiments, the arms may be biased by a separate biasing member such as a spring positioned between the arms.

[0045] Though the barb shown in Figs. 3A-3C is substantially circular in shape, other appropriate shapes may be used. For example, if the connector 110 must fit into a square port, the connector may be configured to include a substantially square barb.

[0046] In the embodiment shown in Fig. 3D, a connector 410 includes a body 412 having a recess 442 positioned at the body distal end 412b and proximal barb 418. The recess 442 and rib of any of the ports (e.g., 2A, 2B and 3E) disclosed herein may be configured to provide tactile and audible feedback to a user, indicating that the barb 418 in engaged with the rib to secure the connector 410 to the port. The recess 442 and port rib connect in an interference fit which yields a water-tight seal between the connector and the port.

[0047] Turning to Fig. 3E, this figure illustrates a port 414 that may be used with any of the suitable connectors disclosed herein. The port 414 is configured to have a rib 422. The rib 422 has two different edge angles. The proximal edge has a tapered lead-in 444. The tapered lead-in 444 may preferably be angled at 30°. However angles between a range of 20° to 60° may be used. The tapered lead-in 444 helps minimize insertion force as the barb passes through the rib 422 during assembly. Furthermore, the distal edge 446 may have a 90° angle to maximize the force required to separate the connector from the port 414, because the distal edge of the barb may also be angled at 90°. There may be a solid interference fit under a tensile load. Additionally, the port 414 is configured to have a shoulder 440. The shoulder 440 may define a gripping member that may be held during the manufacturing process, or the gripping member may be grasped by the user during the catheterization procedure. [0048] For example, during manufacture, the port 414 can be gripped underneath the shoulder 440 by manufacturing equipment. The shoulder 440 provides a gripping point so that the equipment does not have to grip onto a heat seal between a bag and the port 414. Because the equipment grips the shoulder 440 instead of the seal, the shoulder 440 helps minimize the risk that the manufacturing equipment will compromise the integrity of the seal during assembly. Furthermore, if the user connects the catheter to the bag during catheterization, the user may grip the port about the shoulders to hold the port while inserting the connector into the port 414.

[0049] Fig. 3F shows a cross-sectional view of an embodiment of the connector 410-port 414 interface where the port 414 includes a shoulder 440 and the connector 410 includes a recess 442. As mentioned above, the recess 442 of the connector 410 and rib 422 of the port 414 may be configured to provide tactile and audible feedback to a user. The barb 418 of the connector 410 is inserted into the port 414 to a suitable depth to engage and be with the rib 422. Fig. 3F shows the connector 410 fully inserted wherein the barb 418 is positioned distal from the rib 422 such that the connector 410 is detachably secured to the port 414. The rib 422 may be positioned anywhere along the port 414. When the connector 410 is inserted into the port 414, and the barb 418 and rib 422 are connected, a water tight seal is formed. For example, the contact and tolerances between the barb 418 and the rib 422 and/or the rib 422 and the recess 442 may form a water-tight seal. Furthermore, as shown in Fig. 3F, the recess 442 and the rib 422 fit together, strengthening the interference fit between the port 414 and the connector 410. The fit between the recess 442 and the rib 422 may prevent leakage of fluid. In one embodiment, the connector 410-port 414 interface may require a pull-out force of at least 20N to disengage the connector 410 from the port 414.

[0050] Fig. 3G shows a cross-sectional view of an embodiment of the connector 410-port 514 interface where the port 514 includes a rib that is bulb shaped 570. The port 514 also includes a shoulder 540. The connector 410 includes a recess 442. The recess 442 and the bulb-shaped rib 570 engage each other, strengthening the interference fit between the port 514 and the connector 410. In one embodiment, the recess 442 may have a shape that is commensurate with the outer shape of the rib 570. The fit between the recess 442 and the bulb-shaped rib 570 may prevent leakage of fluid. In one embodiment, the connector 410-port 514 interface may require a pull-out force of at least 20N to disengage the connector 410 from the port 514.

[0051] Figs. 4A-4D show an embodiment of the bag 316 wherein the bag 316 has a port 314 including a proximal end 314a, a distal end 314b, and a lumen 315 extending there-through. The port proximal end 314a is configured to receive a connector 110. The port 314 also has a rib where the rib is configured to engage the connector 110, so as to detachably secure the connector 110 to the port 314 and allow the lumen of the port 315 to fluidically communicate with a lumen of the connector 110.

[0052] As shown in Figs. 4A and 4B, the port 314 includes a valve 324. The valve 324 is a non-return valve or anti-reflux valve. In the embodiment shown the valve 324 is an umbrella valve. The valve includes a base 325 extending the width of the port 314. The base 325 includes one or more holes 327 that allow the passage of fluid. The valve also includes a flap 329 that is attached to a stem 331 that is attached to the base 325. The flap 329 is made from an elastic material that flexes away from its original shape to allow fluid flow through the holes 327 and then returns to its original shape to prevent fluid flow through the holes 327. Fig. 4A shows the umbrella valve 324 in a closed position. When the valve 324 is in the closed position, fluid is prevented from flowing or refluxing from the urine collection bag 316 back through the port. The arrows in Fig. 4A show that fluid cannot pass through the umbrella valve 324 when it is closed.

[0053] Fig 4B shows the umbrella valve 324 in an open position. When urine flows from the bladder through the catheter and the connector and into the port, the pressure/force of the urine causes the flap 329 of the valve to flex, thereby uncovering holes 327 and allowing the urine to flow into the bag 316. The arrows shown in Fig. 4B depict the flow of fluid as it flows through the valve 324 and into the bag 316.

[0054] Figs. 4C and 4D show an embodiment of the urinary catheter bag 316 where the port 314 includes a duckbill valve 326. Fig. 4C shows the valve 326 in a closed position. When in the closed position, the duckbill valve 326 fluid is prevented from flowing or refluxing from the urine collection bag 316 back through the port. Fig. 4D shows the duckbill valve 326 in the open position. When urine flows from the bladder through the catheter and the connector and into the port, the pressure/force of the urine causes the duckbill valve to open allowing urine to flow into the bag. Though an umbrella valve 324 and a duckbill valve 326 are shown in the drawings, any other appropriate type of valve may be used. Furthermore, a valve may be incorporated into any of the ports disclosed herein.

In addition, the valve could be incorporated into the connector instead of the port. [0055] As shown in Figs. 4A-4D in some embodiments the urinary catheter bag 316 may comprise a port section 332 and a container section 334. The port section 332 is configured to include the port 314 and the container section 334 is configured to include the bag’s receptacle. In an embodiment, the port section 332 may comprise the portion defining the bag opening. The portion defining the bag opening may be conditioned to be more rigid than at least the container section 334. The port section 332 may be conditioned by annealing. Additionally, the port section 332 may be conditioned by chemical conditioning such as crosslinking. Furthermore, other methods of conditioning to create a more rigid port section 332 may be used. The rigid port section 332 allows for a more stable connection between the connector 110 and the bag 316. The port rigidity of the port section 332 helps to stabilize the valves 324,326, allowing them to open and close without rupturing the port 314. In an embodiment a catheter funnel and/or connector 110 may be mechanically bonded to the port section 332 of the bag 316 such that the connector 110 and/or funnel may fluidically communicate with the bag 316.

[0056] The embodiment in Fig. 5 shows a connector 510 wherein the body 512 includes a selectively removable funnel extension 530. The extension 530 may be detachably connected adjacent to and distal from the barb 518. The extension 530 includes a lumen which fluidically communicates with the lumen of the body 512 to form a continuous lumen 517. The funnel extension 530 is flared toward its distal end 512b and helps to facilitate controlled fluid drainage. The proximal end 512a is configured to fluidically connect to a urinary catheter tube. The funnel extension 530 may be used when a user does not have a bag or need a bag. For example, if a user is in a bathroom and they are near a toilet, the funnel extension 530 may be used to more easily direct urine into the toilet. Alternatively, if the user would prefer to use a urine collection bag, the user may remove the funnel, such as by snapping it off. The user may then connect the connector to the port of the bag, as described above. Additionally, during manufacture, the connectors 510 may be used on both catheters that are not used with bags or catheters that are connected to bags. That is, in the factory, the connector may be placed on catheters that do not require the use of a bag, or the funnel portion could be removed and the catheter could be connected to the bag prior to distribution to the end user.

[0057] Fig. 6 is a close-up cross-sectional view of an embodiment of a bag where the port 614 is integral into the bag. The bag may comprise a first sheet and a second sheet heat sealed about their peripheries wherein the port 614 is defined through the heat seal 616 and the portion 618 of the heat seal 616 defining the port 614 is more rigid than at least a second portion 620 of the heat seal. The port 614 may be conditioned to be more rigid than the remainder of the bag 622. The port 614 may be conditioned by annealing, chemical conditioning such as crosslinking, and/or any other appropriate method for creating a more rigid port 614.

[0058] In the embodiment shown in Fig. 7, the connector 710 includes a body 712 having a bulb-shaped barb 750, at or near the body distal end 712b. In the illustrated embodiment, the barb 750 is spaced from the distal end of the body 712. Fig. 8 shows the connector of Fig. 7 inserted into a port 814. In Fig. 8, the port 814 has a recess 852 designed to receive the barb 750. An inner surface 814c of the port 814 may include the recess 852. The recess 852 may be positioned at any location along the port, and in the illustrated embodiment is positioned near the port proximal end 814a. The barb 750 engages the recess 852 and the barb 750 and recess 852 may be configured to provide tactile and audible feedback to a user, indicating that the barb 750 in engaged with the recess 852 to secure the connector 710 to the port 814. The recess 852 of the port 814 and the bulb-shaped barb 750 of the connector 710 connect in an interference fit which yields a water-tight seal between the connector 710 and the port 814. Additionally, the port 814 is configured to have a shoulder 840. The shoulder 840 may be positioned at the port proximal end 814a.

[0059] In the embodiment shown in Fig. 9, the connector 910 includes a body 912 having a ball-shaped barb 960, at the body distal end 912b. Fig. 10 shows the connector of Fig. 9 inserted into a port 1014. In Fig. 10, the port 1014 has a recess 1062 designed to receive the ball-shaped barb 960. For example, the recess 1062 may have a hollow ball-shape that receives the barb 960. An inner surface 1014c of the port 1014 may include the recess 1062. The recess 1062 may be positioned at any location along the port, and in Fig. 10 the recess 1062 is positioned at the port proximal end 1014a. The recess 1062 may be aligned with the shoulder 1040. The barb 960 fits together with the recess 1062 and the barb 960 and recess 1062 may be configured to provide tactile and audible feedback to a user, indicating that the barb 960 in engaged with the recess 1062 to secure the connector 910 to the port 1014. The recess 1062 and the ball-shaped barb 960 connect in an interference fit which yields a water-tight seal between the connector 910 and the port 1014.

[0060] Fig. 11 A shows a connector 1110 prior to being inserted into a port 1114. The connector 1110 has a body 1112 that includes a recess 1142 positioned near the body distal end 1112b and a barb 1118, positioned at the body distal end 1112b. The port 1114 has two ribs (a first rib 1180a and a second rib 1180b), and a recess 1182. The recess 1182 and ribs 1180a, 1180b may be configured to provide tactile and audible feedback to a user, indicating that the barb 1118 is engaged with the ribs 1180a, 1180b to secure the connector 1110 to the port 1114. The connector barb 1118 and port recess 1182 connect in an interference fit which yields a water-tight seal between the connector 1110 and the port 1114. The first port rib 1180a and the connector recess 1142 connect in an interference fit while the second port rib 1180b helps hold the distal end of the connector 1112b in place, also in an interference fit. Thus, there are three connection points in this embodiment which yields a strong water tight seal between the connector 1110 and the port 1114. [0061] Fig. 11 B shows the connector 1110 of Fig. 11A inserted into the port 1114 of Fig. 11 A. As shown in Fig. 11 B the connector barb 1118 is detachably connected to the port recess 1182. The first port rib 1180a is detachably connected to the connector recess 1142, while the second port rib 1180b is detachably secured to the barb 1118 and the distal end of the connector 1112b. [0062] Fig. 11 C shows the connector 1110 of Fig. 11 A with a modified barb 1118a inserted into the port 1114 of Fig. 11 A. The barb 1118a is modified so that it is slightly recessed from the distal end 1112b of the connector 1110. As shown in Fig. 11 C the connector barb 1118a is detachably connected with the port recess 1182.

[0063] Fig. 12 shows an embodiment of the connector 1210 with a body 1212 having a barb 1290 inserted into a port 1214. The port 1214 has two ribs 1294a,

1294b, a first recess 1292a and a second recess 1292b. The recesses 1292a, 1292b and the ribs 1294a, 1294b may be positioned along the port inner surface 1214c. When the connector 1210 is inserted, the barb 1290 is received by the second recess 1292b. The ribs 1294a, 1294b and the second recess 1292b keep the barb 1290 in place in an interference fit. The interference fit detachably connects the connector 1210 to the port 1214 and yields a water-tight seal between the connector 1210 and the port 1214.

[0064] In each of the embodiments described above, the connector may be made from thermoplastic elastomer (TPE) or any other appropriate material. Additionally, the port may be made from Low Density Polyethylene (LDPE) or any other appropriate material. Finally, the bag may be made from a plastic material having an LDPE inner layer, or any other appropriate material.

[0065] It will be understood that the structures of the connector and the port could be interchanged. For example, the barb could be on the internal wall of the port and the recess could be on the outer wall of the connector. Additionally, while the port is described as receiving the connector, in alternative embodiments, the connector could receive the port.

[0066] It will be understood that the embodiments described above are illustrative of some of the applications of the principles of the present subject matter. Numerous modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including those combinations of features that are individually disclosed or claimed herein. For these reasons, the scope hereof is not limited to the above description but is as set forth in the following claims, and it is understood that claims may be directed to the features hereof, including as combinations of features that are individually disclosed or claimed herein.