Expandable collection bag

Abstract

An expandable collection bag for a urinary catheter assembly includes an outer wall made from an elastic material, a collection chamber formed by the outer wall, the collection chamber having a chamber volume and configured to receive a fluid, and a valve secured to the outer wall and arranged in fluid communication with the collection chamber. The outer wall is configured to expand to increase the chamber volume and contract to decrease the chamber volume. A urinary catheter assembly includes a catheter, a catheter tube, and the expandable collection bag in fluid communication with the catheter tube.

Description

EXPANDABLE COLLECTION BAGDESCRIPTIONTECHNICAL FIELD

[0001] The present disclosure generally relates to a urinary catheter assembly, and more particularly, to an expandable collection bag of a urinary catheter assembly.BACKGROUND

[0002] Intermittent catheterization is a suitable intervention for some users experiencing incomplete bladder emptying. A urinary catheter used for intermittent catheterization is typically provided as a single use, individually packaged item and may include a catheter that is advanced into the urethra to drain urine therefrom. Urine flows through the catheter into a waste bag in fluid communication with the catheter. The waste bag may then be emptied and disposed of.

[0003] Urinary catheter waste bags are typically emptied by tearing the bag along a predetermined line or seam (e.g., a perforated line) to form an opening through which the collected urine may be drained from the bag. However, tearing waste bags in this manner may cause inadvertent spillage of the urine. In addition, urinary catheter waste bags are typically provided having a substantially fixed size and may be difficult to dispose of discretely.

[0004] Thus, it would be desirable to provide a collection bag for a urinary catheter assembly which may be discretely disposed of.SUMMARY

[0005] There are several aspects of the present subject matter. In one aspect, a urinary catheter assembly includes a catheter tube configured for insertion into a urethra and having a drainage passage, and a collection bag in fluid communication with the catheter tube, the collection bag including an outer wall, a collection chamber having a chamber volume formed by the outer wall, and a valve secured to the outer wall and arranged in fluid communication with the collection chamber. The collection chamber is in fluid communication with thedrainage passage, and the outer wall is made from an elastic material such that the outer wall is configured to expand to increase the chamber volume and contract to decrease the chamber volume.

[0006] In another aspect, an expandable collection bag for a urinary catheter assembly includes an outer wall made from an elastic material, a collection chamber formed by the outer wall, the collection chamber having a collection volume and configured to receive a fluid, and a valve secured to the outer wall and arranged in fluid communication with the collection chamber. The outer wall is configured to expand to increase the chamber volume and contract to decrease the chamber volume.Brief Description of Drawings

[0007] FIG. 1 illustrates a urinary catheter assembly having an expandable collection bag in an unloaded condition, according to an embodiment;

[0008] FIG. 2 illustrates the urinary catheter assembly of FIG. 1 with the expandable collection bag in a loaded, at least partially filled, condition;

[0009] FIG. 3 illustrates the urinary catheter assembly of FIGS. 1 and 2, with the expandable collection bag of FIG. 2 being drained; and

[0010] FIG. 4 illustrates the urinary catheter assembly of FIG. 1 , with the expandable collection bag emptied and prepared for disposal.DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0011] 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.

[0012] With reference to FIGS. 1-4, a urinary catheter assembly 10 according to the present examples, such as an intermittent urinary catheter assembly, generally includes a catheter tube 30 and a collection bag 40. The catheter assembly 10, optionally, includes an insertion aid 20 and a protective orno-touch sleeve 22. When included the no-touch sleeve 22 surrounds the catheter tube 30 and the user handles or grasps catheter tube 30 through the no-touch sleeve 22. The insertion aid 20 includes a proximal end 24 configured for insertion into the urethra and the catheter tube 30 includes a proximal end configured to be advanced through the proximal end 24 of the insertion aid 20, through the urethra and into the bladder. The catheter tube 30 includes a drainage passage 32 through which bodily fluid (such as urine) may be drained from the bladder. The collection bag 40 is connected in fluid communication with a distal end 34 of the catheter tube 30.

[0013] The collection bag 40 is configured to receive bodily fluid drained from the bladder through the catheter tube 30. The collection bag 40 includes an outer wall 42 made from an elastic material, a collection chamber 44 formed by the outer wall 42, and an inlet 46 through which the bodily fluid may be received in the collection chamber 44 via the drainage passage 32. A check valve (not shown) may be provided in the inlet to allow one-way flow of bodily fluid into the collection chamber 42, and thus, to prevent bodily fluid from backing up into the catheter, for example into the drainage passage 32. The collection bag 40 further includes a drainage valve 48 (or other known, suitable closure) secured to the outer wall 42. The valve 48 is operable between a closed position and an open position. In the closed position of the valve 48, the collection chamber 44 is substantially sealed from the external environment and the collection bag 40 is configured to receive and store the bodily fluid in the collection chamber 44. In the open position of the valve 48, the collection chamber 44 is in fluid communication with the external atmosphere such that the bodily fluid F (see FIGS. 2 and 3) may be drained from the collection chamber 44 through the open valve 48 (see FIG. 2).

[0014] As shown in FIG. 2, the valve 48 may be a one-way valve or any other suitable valve. In some examples, the valve 48 may be a one-way duck bill valve. The valve 48 may be arranged at or near a bottom of the collection bag 40 to facilitate easy drainage of the bodily fluid F from the collection bag 40. It will be appreciated that the present examples are not limited to a one-way duck bill valve, and that other suitable one-way valves and other valves are envisioned as well. For example, the valve may be a cover that covers a drainage opening, whereinthe cover is removably sealed to outer surface of the collection bag 40. In another alternative, the valve could be a stop-cock valve or a ball valve.

[0015] Referring to FIGS. 1 and 4, the collection bag 40 may be provided in an unloaded condition (FIG. 1 ) in which the elastic material of the outer wall 42 is substantially undeformed elastically and does not exert an elastic biasing force to contract the outer wall 42. As shown in FIG. 2, the collection bag 40 may also be provided in a loaded condition in which the elastic material of the outer wall 42 is elastically deformed and exerts an elastic biasing force to contract the outer wall 42 and return to the unloaded condition. The collection chamber 44 has an unloaded volume in the unloaded condition and a loaded volume in the loaded condition. The loaded volume is greater than the unloaded volume.

[0016] In one example, the collection bag 40 is configured to move from the unloaded condition to the loaded condition in response to receiving and storing in the collection chamber 44 a volume of bodily fluid sufficient to elastically deform the outer wall 42. Elastic deformation of the outer wall 42 increases the volume of the collection chamber 44, for example, to the loaded volume. The collection bag 40 is configured to move from the loaded condition to the unloaded condition in response to draining the bodily fluid from the collection chamber 44 through the open valve 48 as shown in FIG. 2. As the bodily fluid is drained from the collection chamber 44, the outer wall 42 is contracted under the elastic biasing force of the elastic material, and the volume of the collection chamber 44 and the bodily fluid volume within the collection chamber 44 decreases, for example, to the unloaded volume as shown in FIG. 4.

[0017] In use, a patient may be catheterized with the urinary catheter assembly 10 of the present examples such that bodily fluid may be drained from the patient’s bladder via the catheter tube 30 to the collection bag 40. Referring to FIG. 1 , the collection bag 40 may be in a first condition corresponding to the unloaded condition, with the collection chamber 44 having a first chamber volume corresponding to the unloaded volume. In the present example, the first condition corresponds to a condition of the collection bag 40 before bodily fluid is received in the collection chamber 44.

[0018] Referring to FIG. 2, the collection bag 40 may be in a secondcondition in which the valve 48 is closed and the collection bag 40 is configured to receive and store bodily fluid in the collection chamber 44. With a sufficient volume of bodily fluid (a first fluid volume) stored / contained in the collection chamber 44, the collection bag 40 is configured to expand to increase the chamber volume of the collection chamber 44. The sufficient volume may be based on the density of the bodily fluid. In one example, the collection bag 40 is expanded by elastic deformation of the outer wall 42 in response to receiving bodily fluid in the collection chamber 44. In the second condition, the collection chamber 44 has a second chamber volume greater than the first chamber volume. The second condition may correspond to the loaded condition and the second chamber volume may correspond to the loaded volume.

[0019] Referring to FIG. 3, the collection bag 40 may be in a third condition in which the valve 48 is open and the bodily fluid F is drained from collection chamber 44 through the open valve 48. As bodily fluid is drained and decreases to a second fluid volume contained with the collection chamber 44 (which is less than the first fluid volume), the chamber volume decreases due to contraction of the outer wall 42 under the elastic biasing force of the outer wall 42. The chamber volume of the collection chamber 44 while bodily fluid F is drained and the outer wall 42 contracts may be considered a third chamber volume, which is less than the second chamber volume and greater than the first chamber volume.

[0020] Referring to FIG. 4, the collection bag 40 may be in a fourth condition in which the collection chamber 44 is substantially drained of the bodily fluid and has a fourth chamber volume that is equal to, or substantially equal to the first chamber volume. In addition, the fourth condition may substantially correspond to the unloaded condition, such that the outer wall 42 is fully contracted and the elastic material of the outer wall does not exert an elastic biasing force. Thus, after draining the collection bag 40 of bodily fluid, the collection bag 40 may return to its original size.

[0021] The collection bag 40 may be removed from the catheter tube 30 for disposal after draining the bodily fluid from the collection chamber 44. Thus, the collection bag 40 may be at or near its original size (e.g., having the first chamber volume or unloaded volume) when being disposed of. Due to the relatively smallsize of the emptied or unloaded collection bag 40, the collection bag 40 may be disposed of in a convenient and / or more discrete manner compared to conventional collection bags. In addition, by draining the collection bag 40 through the valve 48, there is no need to tear the bag to form an opening for draining bodily fluid. Thus, the chance of inadvertently spilling bodily fluid to drain the collection bag 40 may be reduced by the collection bag 40 of the present examples.

[0022] In the present examples, elastic deformation of the collection bag 40, and in turn, expansion of the collection bag 40, may be varied during manufacture according to the selection of an elastic material, a thickness of the elastic material, and / or other material characteristics and parameters which may affect the strength and / or elasticity of the material used to form the outer wall 42. In the present examples, the elastic material is liquid-impermeable and has a wall thickness suitable for supporting the valve or closure 48, providing suitable durability against puncture and tearing in normal use, and facilitating expansion of the collection bag 40 to receive and store volumes of bodily fluid typically encountered in intermittent urinary catheterization. Such elastic material may include, but are not limited to, Silicone Rubber, Thermoplastic Polyurethane (TPU), Polyethylene (PE), Ethylene Propylene Diene Monomer (EPDM) Rubber, Natural Rubber (Latex), Polyisoprene, Butyl Rubber, Nitrile Rubber, Polychloroprene (Neoprene), Styrene-Butadiene Rubber (SBR), Polyvinyl Chloride (PVC) with plasticizers, Fluoroelastomers (Viton), Thermoplastic Elastomers (TPE), Santoprene, Kraton, Hydrogenated Nitrile Butadiene Rubber (HNBR), Ethylene Vinyl Acetate (EVA), Polybutadiene Rubber, Styrene-Ethylene- Butylene-Styrene (SEBS), and Styrene-lsoprene-Styrene (SIS). These materials may be used individually, in combination with one another, or as laminates thereof, to achieve desired properties for the collection bag 40.

[0023] According to the present examples, the collection bag 40 may be designed to hold a predetermined volume of bodily fluid and is made from a material having suitable elastic properties. The bodily fluid may be received in the collection bag 40 under the force of gravity, such that hydrostatic pressure at a base (lower / bottom end or portion) may be approximated using the followingequation (1 ):(1) P = p x g x hWhere:P denotes the hydrostatic pressure, p represents an approximate density of the bodily fluid (e.g., urine), g represents standard gravitational acceleration, and h is the average height of the fluid column within the bag.

[0024] In one example, the collection bag 40 may be configured to hold 1 L of urine and may be made from Polyvinyl Chloride (PVC). Urine may be introduced into the collection bag 40 and have a density (p) of approximately 1025 kg / m3. The standard gravitational acceleration (g) may be taken as 9.81 m / s2and the average height (h) of the fluid column within the bag 40 may be considered to be 0.25 m.

[0025] Under the parameters above, the computed pressure at the base of the collection bag 40 is about 2.5 kPa. This pressure diminishes linearly from the base to the top of the fluid column, and reaches zero at the peak of the fluid column.

[0026] The actual expansile force exerted by the collection bag’s 40 PVC material, opposing the hydrostatic pressure is contingent upon the specific properties of the PVC used, including but not limited to its thickness, elastic modulus, and design specifications of the collection bag 40. In practical design consideration, a collection bag 40 of 1 L capacity made of PVC would be engineered to tolerate the hydrostatic pressure generated by the designated volume of fluid, with initial expansion occurring with minimal resistance and progressively increasing resistance as the collection bag 40 reaches its full capacity. Such an example serves to illustrate the principles underlying the containment and expansion of liquid n the collection bag 40, and the precise forces and design parameters may be tailored based on the specific characteristics and requirements of the chosen PVC material.

[0027] 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.

Claims

CLAIMS1. A urinary catheter assembly comprising: a catheter tube configured for insertion into a urethra, the catheter tube having a drainage passage configured to receive a bodily fluid; and a collection bag in fluid communication with the catheter tube, the collection bag comprising an outer wall, a collection chamber having a chamber volume formed by the outer wall, and a valve secured to the outer wall and arranged in fluid communication with the collection chamber, wherein the collection chamber is in fluid communication with the drainage passage, and wherein the outer wall is made from an elastic material such that the outer wall is configured to expand to increase the chamber volume and contract to decrease the chamber volume.

2. The urinary catheter assembly according to claim 1 , wherein the outer wall is configured to expand to increase the chamber volume in response to an increase in volume of the fluid received in the collection chamber.

3. The urinary catheter assembly according to claim 2, wherein the outer wall is configured to contract to decrease the chamber volume in response to a decrease in fluid volume of the fluid in the collection chamber.

4. The urinary catheter assembly according to claim 1 , wherein in a first condition, the collection bag is secured to the catheter tube such that the collection chamber is configured to receive a fluid from the drainage passage, and the collection chamber has a first chamber volume.

5. The urinary catheter assembly according to claim 4, wherein in a second condition, a first fluid volume of fluid is contained in the collection chamber, the outer wall is expanded, and the collection chamber has a second chamber volume greater than the first chamber volume.

6. The urinary catheter assembly according to claim 5, wherein in a third condition, the valve is opened to drain fluid from the collection chamber such that a second fluid volume of fluid, less than the first fluid volume of fluid, is contained in the collection chamber, the outer wall is contracted, and the collection chamber has a third chamber volume less than the second chamber volume.

7. The urinary catheter assembly according to claim 6, wherein in the third condition, the third chamber volume is greater than the first chamber volume.

8. The urinary catheter assembly according to claim 6, wherein in a fourth condition, the second volume of fluid is drained from the collection chamber through the valve, the outer wall is further contracted and the collection chamber has a fourth chamber volume less than the third chamber volume.

9. The urinary catheter assembly according to any of claims 1-8, wherein the valve is a one-way valve.

10. The urinary catheter assembly according to any of claims 1-9, further comprising an insertion aid through which the catheter tube extends for advancement into the urethra.

11. An expandable collection bag for a urinary catheter assembly, the expandable collection bag comprising: an outer wall made from an elastic material; a collection chamber formed by the outer wall, the collection chamber having a chamber volume volume and configured to receive a fluid; and a valve secured to the outer wall and arranged in fluid communication with the collection chamber, wherein the outer wall is configured to expand to increase the chamber volume and contract to decrease the chamber volume.

12. The expandable collection bag according to claim 11 , wherein in an unloaded condition, the valve is closed, the collection chamber is configured to receive the fluid, and the collection chamber has a first chamber volume.

13. The expandable collection bag according to claim 12, wherein in a loaded condition, the valve is closed, the outer wall is expanded and the collection chamber has a second chamber volume greater than the first chamber volume.

14. The expandable collection bag according to claim 13, wherein in a second unloaded condition, the valve is opened, the outer wall is contracted, and the collection chamber has a third chamber volume less than the second chamber volume.

15. The expandable collection bag according to any of claims 11-14, wherein the valve is a one-way valve.

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