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Title:
CATHETER PASSAGEWAY CLEARING DEVICES AND METHODS OF CLEARING CATHETER PASSAGEWAYS
Document Type and Number:
WIPO Patent Application WO/2024/043901
Kind Code:
A1
Abstract:
A catheter passageway clearing device (10, 60, 90, 120) includes a compressible member (12, 62, 160) that has a decreased internal volume when in a compressed configuration and is movable toward an original, inflated configuration of increased internal volume. The compressible member (12, 62, 160) includes a compressible portion (14, 64, 108, 142, 162) and an air flow control portion (16, 66). A movable internal switchable one-way valve (28, 28a, 28b, 70, 94, 124, 150) is located in the air flow control portion (16, 66). An actuation device (22, 72, 86, 72, 92, 122) is actuatable between a first configuration and a second configuration such that, in the first configuration, the actuation device (22, 72, 86, 72, 92, 122) places the internal switchable one-way valve (28, 28a, 28b, 70, 94, 124, 150) in an active configuration, and an inactive configuration.

Inventors:
KEARNEY CHRISTINE (US)
Application Number:
PCT/US2022/041647
Publication Date:
February 29, 2024
Filing Date:
August 26, 2022
Export Citation:
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Assignee:
BARD PERIPHERAL VASCULAR INC (US)
International Classes:
A61M25/00; A61M13/00
Domestic Patent References:
WO2014043650A22014-03-20
WO2009035458A12009-03-19
Foreign References:
FR2455456A11980-11-28
US20170281881A12017-10-05
Attorney, Agent or Firm:
ELSWICK, Christopher W. et al. (US)
Download PDF:
Claims:
CLAIMS

1. A catheter passageway clearing device comprising: a compressible member that has a decreased internal volume when in a compressed configuration and is movable toward an original, inflated configuration of increased internal volume, wherein the compressible member comprises a compressible portion and an air flow control portion; a movable internal switchable one-way valve is located in the air flow control portion; and an actuation device that is operatively connected to the internal switchable one-way valve, the actuation device actuatable between a first configuration and a second configuration such that, in the first configuration, the actuation device places the internal switchable one-way valve in an active configuration in which the internal switchable one-way valve allows airflow into the compressible portion via the air flow control portion when the compressible portion is expanded, and inhibits air from flowing out of the compressible portion and through the air flow control portion when the compressible portion is compressed and, in the second configuration, the actuation device places the internal switchable one-way valve in an inactive configuration in which the internal switchable one-way valve allows air to flow out of the compressible portion and through the air flow control portion when the compressible portion is compressed.

2. The catheter passageway clearing device of claim 1 further comprising an external switchable one-way valve located at an outlet opening of the compressible portion, the external switchable one-way valve allowing air flow out of the compressible portion to the environment when the compressible portion is compressed.

3. The catheter passageway clearing device of claim 2, wherein the external switchable oneway valve has an open configuration allowing air to escape from the compressible portion to the environment with the actuation device in the first configuration, the external switchable one-way valve having a closed configuration with the actuation device in the second configuration inhibiting air flow through the second one-way valve when the compressible portion is compressed.

4. The catheter passageway clearing device of claim 3, wherein the external switchable oneway valve is configured to prevent air from entering the compressible portion with the actuation device in the first configuration when the compressible portion is released from the compressed configuration, the internal switchable one-way valve allowing air to pass therethrough into the compressible portion thereby introducing a suction force to the air flow control portion that is configured to connect to an insertion tube.

5. The catheter passageway clearing device of claim 3, wherein the actuation device comprises the external switchable one-way valve.

6. The catheter passageway clearing device of claim 1 further comprising an elongated insertion tube that is communicatively coupled to the air flow control portion, the elongated insertion tube having an outer diameter sized to be received within an internal lumen of a drainage catheter.

7. The catheter passageway clearing device of claim 6, wherein the elongated insertion tube has a length that is greater than a length of the drainage catheter such that the elongated insertion tube can be inserted entirely through the drainage catheter.

8. The catheter passageway clearing device of claim 1 further comprising a saline delivery device configured for delivering saline into the compressible portion.

9. The catheter passageway clearing device of claim 1, wherein the actuation device is operatively connected to the internal switchable one-way valve by a linkage.

10. The catheter passageway clearing device of claim 1, wherein the compressible portion comprises a squeeze bulb, bellows or a syringe.

11. A method of clearing an internal lumen of an implantable drainage catheter using a catheter passageway clearing device, the method comprising: inserting an elongated insertion tube of the catheter passageway clearing device into the internal lumen of the drainage catheter, the elongated insertion tube connected to an air flow control portion of a compressible member comprising a compressible portion and the air flow control portion; and actuating an actuation device carried by the compressible member from a first configuration placing an internal switchable one-way valve in the air flow control portion in an active configuration in which the internal switchable one-way valve allowing airflow into the compressible portion from the air flow control portion when the compressible portion is expanded and inhibiting air from flowing out of the compressible portion and through the air flow control portion when the compressible portion is compressed, to a second configuration placing the internal switchable one-way valve in an inactive position in which the internal switchable oneway valve allowing air to flow out of the compressible portion and through the air flow control portion when the compressible portion is compressed.

12. The method of claim 11 further comprising an external switchable one-way valve located at an outlet opening of the compressible portion, external switchable one-way valve allowing airflow out of the compressible portion to the environment.

13. The method of claim 12, wherein the external switchable one-way valve has an open configuration allowing air to escape from the compressible portion to the environment with the actuation device in the first configuration, the external switchable one-way valve has a closed configuration with the actuation device in the second configuration inhibiting air flow through the external switchable one-way valve.

14. The method of claim 13, wherein the external switchable one-way valve preventing air from entering the compressible portion with the actuation device in the first configuration when the compressible portion is released, the internal switchable one-way valve allowing air to pass therethrough into the compressible portion from the air flow control portion thereby introducing a suction force to the insertion tube.

15. The method of claim 14, wherein the actuation device comprises the external switchable one-way valve.

16. The method of claim 15, wherein the elongated insertion tube has a length that is greater than a length of the drainage catheter such that the elongated insertion tube can be inserted entirely through the drainage catheter.

17. The method of claim 11 further comprising delivering saline into the compressible portion using a saline delivery device.

18. The method of claim 11, wherein the actuation device is operatively connected to the oneway valve by a linkage.

19. The method of claim 11, wherein the actuation device comprises a knob or button.

20. The method of claim 11, wherein the compressible portion comprises a squeeze bulb, bellows or syringe.

Description:
CATHETER PASSAGEWAY CLEARING DEVICES AND METHODS OF CLEARING

CATHETER PASSAGEWAYS

TECHNICAL FIELD

[0001] The present specification generally relates to drainage systems and methods for draining bodily fluid and, more specifically, to catheter passageway clearing devices and methods of clearing catheter passageways of indwelling drainage catheters.

BACKGROUND

[0002] The pleural cavity is the thin, fluid-filled space between the two pulmonary pleurae (known as visceral and parietal) of each lung. A pleura is a serous membrane that folds back onto itself to form a two-layered membranous pleural sac. The pleural space is normally filled with approximately five to 20 mL of serous fluid. The turnover of fluid in the pleural space is normally quite rapid - roughly 35 to 75% of the total fluid per hour, so that 5 to 10 L of fluid moves through the pleural space each day. A pleural effusion is a build-up of fluid in the pleural space. A pleural effusion may also be referred to as effusion or pulmonary effusion. The type of fluid that forms a pleural effusion may be categorized as transudate or exudate.

[0003] Peritoneal effusion or ascites refers to an excess collection of fluid in the abdominal cavity, such as more than 25 mL of fluid. The most common cause of such excess fluid collection is liver cirrhosis and other causes include cancer and pancreatitis.

[0004] There are a number of drainage systems for managing recurrent pleural effusions and ascites at home. Two such systems are the PleurX™ and PeritX™ drainage systems, commercially available from Becton, Dickinson and Company. These systems utilize an indwelling catheter and drainage bottles that collect fluid. The indwelling catheter is inserted, typically as a simple outpatient procedure, in the chest for draining pleural effusions or in the abdomen for ascites. An end of the indwelling catheter stays outside of the body, hidden under a bandage when not in use. To drain, the end of the indwelling catheter is connected to a drainage line on the bottle that is pre-evacuated to provide a negative pressure, and the negative pressure inside the bottle is used to draw out the bodily fluid. Alternatively, a gravity-fed bag, wall- mounted suction system, or electromechanical pump may be used for draining bodily fluids. [0005] From time to time, blockages may occur within the indwelling catheter. The indwelling catheters usually clog due to formation of fibrin or other types of tissue/cellular clots. Typically, the indwelling catheter may be flushed with saline or use fibronolytic enzymes such as tissue plasminogen activator (tPA) and deoxyribonuclease (DNase). With the increasing adoption of talc use in the pleural space, the typical approaches to clot digestion can have a reduced effectiveness if clogged with inorganic material.

SUMMARY

[0006] According to a first embodiment, a catheter passageway clearing device includes a compressible member that has a decreased internal volume when in a compressed configuration and is movable toward an original, inflated configuration of increased internal volume. The compressible member includes a compressible portion and an air flow control portion. A movable internal switchable one-way valve is located in the air flow control portion. An actuation device is operatively connected to the internal switchable one-way valve. The actuation device is actuatable between a first configuration and a second configuration such that, in the first configuration, the actuation device places the internal switchable one-way valve in an active configuration in which the internal switchable one-way valve allows airflow into the compressible portion via the air flow control portion when the compressible portion is expanded, and inhibits air from flowing out of the compressible portion and through the air flow control portion when the compressible portion is compressed and, in the second configuration, the actuation device places the internal switchable one-way valve in an inactive configuration in which the internal switchable one-way valve allows air to flow out of the compressible portion and through the air flow control portion when the compressible portion is compressed.

[0007] According to another embodiment, a method of clearing an internal lumen of an implantable drainage catheter using a catheter passageway clearing device is provided. The method includes inserting an elongated insertion tube of the catheter passageway clearing device into the internal lumen of the drainage catheter. The elongated insertion tube connected to an air flow control portion of a compressible member comprising a compressible portion and the air flow control portion. An actuation device is actuated from a first configuration placing an internal switchable one-way valve in the air flow control portion in an active configuration in which the internal switchable one-way valve allowing airflow into the compressible portion from the air flow control portion when the compressible portion is expanded and inhibiting air from flowing out of the compressible portion and through the air flow control portion when the compressible portion is compressed, to a second configuration placing the internal switchable one-way valve in an inactive position in which the internal switchable one-way valve allowing air to flow out of the compressible portion and through the air flow control portion when the compressible portion is compressed.

[0008] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the subject matter defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which:

[0010] FIG. 1 schematically depicts a partial internal view of a catheter passageway clearing device with an internal switchable one-way valve in an active configuration, according to one or more embodiments shown and described herein;

[0011] FIG. 2 schematically depicts the internal switchable one-way valve of FIG. 1 in an inactive configuration, according to one or more embodiments shown and described herein;

[0012] FIG. 3 is a diagrammatic representation of the catheter passageway clearing device of FIG. 1, according to one or more embodiments shown and described herein;

[0013] FIG. 4 schematically depicts an embodiment internal switchable one-way valve assembly for use with the catheter passageway clearing device of FIG. 1, according to one or more embodiments shown and described herein;

[0014] FIG. 5 schematically depicts another internal switchable one-way valve assembly for use with the catheter passageway clearing device of FIG. 1, according to one or more embodiments shown and described herein;

[0015] FIG. 6 schematically depicts the catheter passageway clearing device of FIG. 1 in use, according to one or more embodiments shown and described herein; [0016] FIG. 7 schematically depicts partial internal view of another catheter passageway clearing device with an internal switchable one-way valve, according to one or more embodiments shown and described herein;

[0017] FIG. 8 is a detail view of a guide track for use with the catheter passageway clearing device of FIG. 7, according to one or more embodiments shown and described herein;

[0018] FIG. 9 schematically depicts an partial internal view of another catheter passageway clearing device with an internal switchable one-way valve, according to one or more embodiments shown and described herein;

[0019] FIG. 10 schematically depicts another catheter passageway clearing device with an internal switchable one-way valve, according to one or more embodiments shown and described herein;

[0020] FIG. 11 schematically depicts a partial internal view of the catheter passageway clearing device of FIG. 10 in an ON position, according to one or more embodiments shown and described herein;

[0021] FIG. 12 schematically depicts a partial internal view of the passageway clearing device of FIG. 10 in an OFF position, according to one or more embodiment shown and described herein;

[0022] FIG. 13 schematically depicts a partial internal view of another catheter passageway clearing device with internal switchable one-way valve in an ON position, according to one or more embodiments shown and described herein;

[0023] FIG. 14 schematically depicts a partial internal view of the catheter passageway clearing device of FIG. 13 in an OFF position, according to one or more embodiments shown and described herein;

[0024] FIG. 15 schematically depicts the internal switchable one-way valve assembly of FIG.

13, according to one or more embodiments shown and described herein;

[0025] FIG. 16 schematically depicts the internal switchable one-way valve assembly of FIG.

14, according to one or more embodiments shown and described herein;

[0026] FIG. 17 schematically depicts a collapsible member for use with a catheter passageway clearing device, according to one or more embodiments shown and described herein; [0027] FIG. 18 schematically depicts another collapsible member for use with a catheter passageway clearing device, according to one or more embodiments shown and described herein; and

[0028] FIG. 19 schematically depicts a collapsible member for use with a catheter passageway clearing device, according to one or more embodiments shown and described herein.

DETAILED DESCRIPTION

[0029] Embodiments described herein are generally directed to a catheter passageway clearing device. The catheter passageway clearing device includes a compressible portion that decreases in internal volume when in a compressed configuration. The compressible portion is movable toward an original, inflated configuration of increased internal volume, and includes a compressible portion and an air flow control portion. A movable one-way valve is located in the air flow control portion. An actuation device carried by the compressible member is operatively connected to the one-way valve such that placing the actuation device in an ON position places the one-way valve in an active configuration so as to allow suction into the compressible portion and inhibit air from flowing out of the compressible portion and through the air flow control portion when the compressible portion is compressed. Placing the actuation device in an OFF position places the one-way valve in an inactive configuration so as to allow air to flow out of the compressible portion and through the air flow control portion when the compressible portion is compressed.

[0030] The clearing devices used herein may be for use with drainage systems suitable for pleural and peritoneal drainage operations using an indwelling drainage catheter, or any other externally-accessible catheter that is prone to clogging. For example, the clearing devices could be used with percutaneous drainage catheters, abscess, biliary, urinary and general drainage catheters. The drainage systems may include a pump or vacuum bottle that can be used to enhance flow of bodily fluid from a body cavity and into a fluid-receiving container, such as a vacuum bottle. Once a drainage line is attached to the indwelling drainage catheter, fluid may begin to flow without assistance from the pump or vacuum bottle, through the drainage line and toward the fluid-receiving container, which is considered gravity drainage. The pump or vacuum bottle can provide a suction to a fluid-receiving passageway that passes through the drainage line and the indwelling drainage catheter. Other examples of externally-accessible catheters prone to clogging include: general chest tubes, dialysis catheters (hemodialysis and peritoneal dialysis), external ventricular drains (EVDs), CSF drainage catheters (ventricular and lumbar), pericardial effusion drainage catheters, urinary drainage catheters, central venous catheters (CVCs), peripherally inserted central catheters (PICCs), post-surgical wound drains, etc. The clearing devices may also be used with other, non-catheter devices prone to clogging, such as ports and feeding tubes.

[0031] Referring to FIGS. 1 and 2, a catheter passageway clearing device 10 includes a compressible member 12. In the example of FIGS. 1 and 2, the compressible member 12 includes a compressible portion 14 (e.g., a bulb, accordion, spring-loaded volume, syringe, etc.) and an air flow control portion 16. As used herein, the term “compressible portion” refers to a vessel that has an internal volume that can be reduced in size in order to force air and other contents out of the internal volume. The internal volume of the compressible portion may then be expanded to force air and other contents into the internal volume. The internal volume may be compressible manually and the compressible member can be formed of a resilient material that is biased to expand to its original internal volume when collapsed to a decreased internal volume, or the internal volume may be expanded by manually or otherwise applying an opening force that forces the compressible member toward a fully expanded configuration. The compressible portion 14 may be generally spherical in shape having an enlarged width that necks down in a necked-down region toward the air flow control portion 16 that is generally frustoconical in shape. In other embodiments, the compressible portion 14 may be other suitable shapes and configurations as will be described in greater detail below. The air flow control portion 16 may also taper in width and is sealingly engaged with an insertion tube 20 that has an outer diameter (e.g., 16 Fr or less, such as 15 Fr or less, such as 14 Fr or less, such as 14 Fr or less, such as 12 Fr or less, such as 10 Fr or less) that is sized to be threaded through an internal lumen of a drainage catheter. Further, the insertion tube 20 may have a length that is sized to be fed through and, in some embodiments, beyond an entire length of the drainage catheter.

[0032] The compressible portion 14 may be formed of a resilient and flexible material such that the compressible portion 14 can be manually squeezed to a compressed configuration in order to decrease its internal volume and force air out of the compressible portion 14. Because the compressible portion 14 is formed of a resilient material, the compressible portion 14 is biased toward an original, inflated configuration of increased internal volume.

[0033] Collapsing the compressible portion 14 forces air out of its internal volume acting as a displacement pump. The displaced air can exit the compressible portion 14 through the air flow control portion 16 or through an actuation device 22 that includes an outlet 24 for allowing air to escape directly through a sidewall of the compressible portion 14. The actuation device 22 may include a knob, lever, button, dial, etc. that can be manually actuated between open and closed configurations (also referred to as ON and OFF positions).

[0034] Referring also to FIG. 3, the actuation device 22 may be a knob or dial that is linked to an external switchable one-way valve 26 that can be moved by rotating the actuation device 22 between an open configuration with the actuation device 22 in the ON position (FIG. 1) and a closed configuration with the actuation device 22 in the OFF position (FIG. 2). In the open configuration, the external switchable one-way valve 26 allows air to escape the compressible portion 14 through the external switchable one-way valve 26 when the compressible portion 14 is squeezed and prevents air from entering the compressible portion 14 therethrough when the compressible portion 14 is released and expands. An internal switchable one-way valve 28 is located in the air flow control portion 16. The actuation device 22 carried by the compressible portion 14 is operatively connected to the internal switchable one-way valve 28 by a linkage 30 such that placing the actuation device 22 in the ON position places the internal switchable oneway valve 28 in an active configuration. In the active configuration, the internal switchable oneway valve 28 inhibits air from flowing out of the compressible portion 14 and through the air flow control portion 16 when the compressible portion 14 is squeezed and allows air to enter the compressible portion 14 therethrough when the compressible portion 14 is released and expands. Placing the actuation device 22 in the OFF position places the internal switchable one-way valve 28 in an inactive configuration so as to allow air to freely flow out of and into the compressible portion 14 when the compressible portion 14 is squeezed and expands and also places the external switchable one-way valve 26 in the closed configuration that prevents air from entering and exiting therethrough. As such, the ON position may be referred to as a suction mode where a suction force is provided through the insertion tube 20 when the compressible portion 14 is released and expands and the OFF position may be referred to as a pumping mode where air can be forced both ways through the insertion tube 20, for example, to clear clogs through the insertion tube 20.

[0035] FIGS. 4 and 5 illustrate two internal switchable one-way valve examples 28a and 28b that use docking bases 31 and 32 to achieve the active and inactive configurations. In FIG. 4, the docking base 31 may be fixed to an inner surface 33 of the air flow control portion 16. A biasing member 34, such as a spring may connect the internal switchable one-way valve 28 and the docking base 31. The linkage 30, which may be flexible (e.g., a tether) or rigid (e.g., one or more rods, gears, etc.) operably connects the actuation device 22 to the internal switchable one-way valve 28a. Moving the actuation device 22 from the ON position, as shown by step 52, to the OFF position, as shown by step 54, forces the internal switchable one-way valve 28 away from the docking base 31 to place the clearing device in the pumping mode. Moving the actuation device 22 from the OFF position to the ON position reduces the force on the internal switchable one-way valve 28 such that the biasing member 34 can draw the internal switchable one-way valve 28 back onto the docking base 31. FIG. 5 illustrates an embodiment that uses the docking base 32 with a biasing member 39 including a permanent magnet that is tethered to internal switchable one-way valve 28b by tethers 41. In some embodiments, the linkage 30 may be configured to move the internal switchable one-way valve 28 alone between the active and inactive configurations. The docking base 31, 32 may include a retaining structure that receives the internal switchable oneway valve 28 and holds the internal switchable one-way valve 28 in place, for example, using a snap fit.

[0036] Referring to FIG. 6, the clearing device 10 is shown in use with the insertion tube 20 inserted through the entire length of an indwelling drainage catheter 40. The insertion tube 20 may be formed using a material having enough rigidity and flexibility to be inserted entirely through the drainage catheter 40. The end 42 of the insertion tube 20 may be formed atraumatic as the end 42 may protrude from an end 44 of the drainage catheter 40.

[0037] In use, when a clog in the drainage catheter 40 is detected, the clearing device 10 may be set to either the suction mode or the pumping mode depending on the usage preference of the user depending, at least in part, on the type and location of the clog. When the suction mode is desired, the actuation device 22 may be set to the ON position. In the ON position, in embodiments where the external switchable one-way valve 26 is provided, the external switchable one-way valve 26 is placed in the open configuration which allows air to escape the compressible portion 14 when the compressible portion 14 is compressed and blocks air from entering the compressible portion 14 when the compressible portion is released. Further, the internal switchable one-way valve 28 is placed in the active configuration which inhibits air from travelling into the insertion tube 20 from the compressible portion 14 when the compressible portion 14 is compressed and allows air to flow from the insertion tube 20 into the compressible portion 14 when the compressible portion is released and expands. When the pumping mode is desired, the actuation device 22 may be set to the OFF position. In the OFF position, in embodiments where the external switchable one-way valve 26 is present, the external switchable one-way valve 26 is placed in the closed configuration which prevents air from escaping the compressible portion 14 when the compressible portion 14 is compressed and also prevents air from entering the compressible portion 14 when the compressible portion is released. Further, the internal switchable one-way valve 28 is placed in the inactive configuration which allows air to travel into the insertion tube 20 from the compressible portion 14 when the compressible portion 14 is compressed and also allows air to flow from the insertion tube 20 into the compressible portion 14 when the compressible portion is released and expands providing the pumping action.

[0038] FIG. 7 illustrates another embodiment of a catheter passage clearing device 60 which includes many of the features described above including a compressible member 62 with a compressible portion 64, an air flow control portion 66, an external switchable one-way valve 68, an internal switchable one-way valve 70, an actuation member 72 and a linkage 74 that operatively connects the actuation member 72 to the internal switchable one-way valve 70. As above, moving the actuation member 72 from an ON position to an OFF position moves the internal switchable one-way valve 70 from an active configuration to an inactive configuration. In this embodiment, referring to FIG. 8, a guide track 75 is provided along internal surface 76 of the compressible portion 64 along which the internal switchable one-way valve 70 travels. In particular, in this example, the guide track 75 includes guide portions 78 and 80 that extend along the internal surface 76 toward and away from the air flow control portion 66. The internal switchable oneway valve 70 includes a frame 82 that extends beneath the guide portions 78 and 80. The linkage

74 may be formed of a flexible material (e.g., stainless steel or plastic) that is also stiff enough to push and pull the internal switchable one-way valve 70 along the guide track 75. The guide track

75 may extend to an opening 84 to the flow control portion 66 such that the internal switchable one-way valve 70 is movable to a position in which it seals and covers the opening 84.

[0039] In some embodiments, referring to FIG. 9, a sliding actuator member 86 may be used in addition to or as an alternative to the rotating actuator member 72 of FIG. 7 to move the linkage 74 and the internal switchable one-way valve 70 between the active and inactive configurations. Seating aids, such as a magnet (e.g., magnet pair on the one-way valve 70 and the opening 84, or a magnet-magnetic material pair), can be provided to help the internal-one way valve 70 to seat at the opening 84 in a reliable and repeatable fashion.

[0040] Referring to FIG. 10, another embodiment of a catheter passage clearing device 90 uses another type of actuation member 92 that is used to move an internal switchable one-way valve 94 (FIG. 11) between active and inactive configurations. In this embodiment, the actuation member 92 is a dial that operates similar to a revolving nosepiece of a microscope. The actuation member 92 may be provided in addition to another actuation member 95 that is used to control opening and closing of an external switchable one-way valve 96. Turning the actuation member 92 from an ON position to an OFF position moves the internal switchable one-way valve 94 from an active configuration to an inactive configuration. In particular, referring to FIGS. 11 and 12, the actuation member 92 includes an internal plate 100 that carries the internal switchable oneway valve 94 and a thru opening 102. When the actuation member 92 is moved to the ON position, the internal switchable one-way valve 94 is aligned with a passageway 104 through flow control portion 106 and allows only suction into compressible portion 108 as represented by arrow 110. With the actuation member 92 in the ON position, the other actuation member 95 may be placed in an ON position to open external switchable one-way valve 112 and allow air flow out of the compressible portion 108 when the compressible portion 108 is squeezed. When the actuation member 92 is moved to the OFF position, the internal switchable one-way valve 94 is moved out of alignment with the passageway 104 and the thru opening 102 is aligned with the passageway 104 to allow air and other materials out of and into the compressible portion 108 as the compressible portion 108 is collapsed and released as represented by arrow 113. With the actuation member 92 in the ON position, the other actuation member 95 may be placed in the OFF position to close the external switchable one-way valve 96 and prevent air from exiting the compressible portion 108.

[0041] Referring to FIG. 13, another embodiment of a catheter passage clearing device 120 uses another type of actuation member 122 (shown in part in dashed lines) that is used to move an internal switchable one-way valve 124 between active and inactive configurations. In this embodiment, the actuation member 122 is a dial that operates similar to an aperture of a lens. The actuation member 122 may be provided in addition to another actuation member 125 that is used to control opening and closing of an external switchable one-way valve 126. Turning the actuation member 122 from an ON position to an OFF position moves the internal switchable one-way valve 124 from an active configuration (FIGS. 13 and 15) to an inactive configuration (FIGS. 14 and 16). In particular, referring to FIGS. 13-16, the actuation member 122 includes a plurality of movable blades 130 that move inward to close the internal switchable one-way valve 124 with the actuation member 122 in the ON position and outward to open the internal switchable one-way valve 124 with the actuation member 122 in the OFF position. The moveable blades 130 may be curved to form the internal switchable one-way valve 124 themselves, or the moveable blades 130 may push another valve structure, such as a film, open and closed to form the internal switchable one-way valve 124.

[0042] While a resiliently compressible bulb structure is shown forming the compressible members discussed above, other compressible portion configurations may be used. Referring to FIG. 17, compressible member 140 includes a compressible portion 142 that is accordion-shaped including bellows 144. The compressible portion 142 may be manually expanded and contracted by pulling and pushing ends 146 and 148 apart and together to draw and push through internal switchable one-way valve 150 and into and out of compressible portion 142 ad discussed above. In a variation, referring to FIG. 18, the compressible member 140 may have an internal spring 152 or other biasing member to bias the compressible portion 142 toward an expanded configuration.

[0043] Referring to FIG. 19, in another embodiment, a compressible member 160 may include a compressible portion 162 that is formed by a fixed outer wall 164 and a plunger 166. The outer wall 164 and plunger 166 may operate similar to a syringe and compress and expand internal volume 168 of the compressible portion 162 by manually pushing and pulling a stopper 170 of the plunger 166 toward and away from a bottom 172 of outer wall 164.

[0044] The above-described catheter passageway clearing devices provide a mechanism that can be used to clear clogs in drainage catheters by (1) pushing the clog out by inserting the insertion tube, (2) dragging the clog out using the suction provided by the expanding compressible portion in the suction mode and (3) breaking the clog using the pumping action provided by the compressible portion in the pumping mode. In the active configuration, the internal switchable one-way valve prevent air from being pushed into the pleural space while still allowing suction. In some embodiments, shown by FIG. 1, a pump device 50 may be provided that can deliver a fluid, such as saline or fibrinolytics into the compressible member and pumping the fluid toward the clog. For example, the pump device 50 may be a saline delivery device that pumps saline through a connected tube (shown by dashed lines) into the compressible member.

[0045] Embodiments can be described with reference to the following numbered clauses, with certain features laid out in the dependent clauses:

[0046] Clause 1 : A catheter passageway clearing device comprising: a compressible member that has a decreased internal volume when in a compressed configuration and is movable toward an original, inflated configuration of increased internal volume, wherein the compressible member comprises a compressible portion and an air flow control portion; a movable internal switchable one-way valve is located in the air flow control portion; and an actuation device that is operatively connected to the internal switchable one-way valve, the actuation device actuatable between a first configuration and a second configuration such that, in the first configuration, the actuation device places the internal switchable one-way valve in an active configuration in which the internal switchable one-way valve allows airflow into the compressible portion via the air flow control portion when the compressible portion is expanded, and inhibits air from flowing out of the compressible portion and through the air flow control portion when the compressible portion is compressed and, in the second configuration, the actuation device places the internal switchable one-way valve in an inactive configuration in which the internal switchable one-way valve allows air to flow out of the compressible portion and through the air flow control portion when the compressible portion is compressed.

[0047] Clause 2: The catheter passageway clearing device of clause 1 further comprising an external switchable one-way valve located at an outlet opening of the compressible portion, the external switchable one-way valve allowing air flow out of the compressible portion to the environment when the compressible portion is compressed.

[0048] Clause 3 : The catheter passageway clearing device of clause 2, wherein the external switchable one-way valve has an open configuration allowing air to escape from the compressible portion to the environment with the actuation device in the first configuration, the external switchable one-way valve having a closed configuration with the actuation device in the second configuration inhibiting air flow through the second one-way valve when the compressible portion is compressed.

[0049] Clause 4: The catheter passageway clearing device of clause 3, wherein the external switchable one-way valve is configured to prevent air from entering the compressible portion with the actuation device in the first configuration when the compressible portion is released from the compressed configuration, the internal switchable one-way valve allowing air to pass therethrough into the compressible portion thereby introducing a suction force to the air flow control portion that is configured to connect to an insertion tube.

[0050] Clause 5: The catheter passageway clearing device of clause 3 or clause 4, wherein the actuation device comprises the external switchable one-way valve.

[0051] Clause 6: The catheter passageway clearing device of any of clauses 1-5 further comprising an elongated insertion tube that is communicatively coupled to the air flow control portion, the elongated insertion tube having an outer diameter sized to be received within an internal lumen of a drainage catheter.

[0052] Clause 7: The catheter passageway clearing device of clause 6, wherein the elongated insertion tube has a length that is greater than a length of the drainage catheter such that the elongated insertion tube can be inserted entirely through the drainage catheter.

[0053] Clause 8: The catheter passageway clearing device of any of clause 1-7 further comprising a saline delivery device configured for delivering saline into the compressible portion.

[0054] Clause 9: The catheter passageway clearing device of any of clauses 1-8, wherein the actuation device is operatively connected to the internal switchable one-way valve by a linkage.

[0055] Clause 10: The catheter passageway clearing device of any of clauses 1-9, wherein the compressible portion comprises a squeeze bulb, bellows or a syringe.

[0056] Clause 11 : A method of clearing an internal lumen of an implantable drainage catheter using a catheter passageway clearing device, the method comprising: inserting an elongated insertion tube of the catheter passageway clearing device into the internal lumen of the drainage catheter, the elongated insertion tube connected to an air flow control portion of a compressible member comprising a compressible portion and the air flow control portion; and actuating an actuation device from a first configuration placing an internal switchable one-way valve in the air flow control portion in an active configuration in which the internal switchable one-way valve allowing airflow into the compressible portion from the air flow control portion when the compressible portion is expanded and inhibiting air from flowing out of the compressible portion and through the air flow control portion when the compressible portion is compressed to a second configuration placing the internal switchable one-way valve in an inactive position in which the internal switchable one-way valve allowing air to flow out of the compressible portion and through the air flow control portion when the compressible portion is compressed.

[0057] Clause 12: The method of clause 11 further comprising an external switchable one-way valve located at an outlet opening of the compressible portion, external switchable one-way valve allowing airflow out of the compressible portion to the environment.

[0058] Clause 13: The method of clause 12, wherein the external switchable one-way valve has an open configuration allowing air to escape from the compressible portion to the environment with the actuation device in the first configuration, the external switchable one-way valve has a closed configuration with the actuation device in the second configuration inhibiting air flow through the external switchable one-way valve.

[0059] Clause 14: The method of clause 13, wherein the external switchable one-way valve preventing air from entering the compressible portion with the actuation device in the first configuration when the compressible portion is released, the internal switchable one-way valve allowing air to pass therethrough into the compressible portion from the air flow control portion thereby introducing a suction force to the insertion tube.

[0060] Clause 15: The method of clause 14, wherein the actuation device comprises the external switchable one-way valve.

[0061] Clause 16: The method of clause 15, wherein the elongated insertion tube has a length that is greater than a length of the drainage catheter such that the elongated insertion tube can be inserted entirely through the drainage catheter.

[0062] Clause 17: The method of any of clauses 11-16 further comprising delivering saline into the compressible portion using a saline delivery device.

[0063] Clause 18: The method of any of clauses 11-17, wherein the actuation device is operatively connected to the one-way valve by a linkage.

[0064] Clause 19: The method of any of clauses 11-18, wherein the actuation device comprises a knob or button.

[0065] Clause 20: The method of any of clauses 11-19, wherein the compressible portion comprises a squeeze bulb, bellows or syringe.

[0066] Clause 21 : A drainage system kit comprising: a drainage catheter configured to be routed through a body of a patient to a body cavity for use in draining bodily fluids; and a catheter passageway clearing device comprising: an insertion tube configured to be inserted through the drainage catheter to cleat a clog inside the drainage catheter; a compressible member that decreases in internal volume when in a compressed configuration and is biased toward and original, inflated configuration of increased internal volume, wherein the compressible member comprises a compressible portion and an air flow control portion; a movable internal switchable one-way valve is located in the air flow control portion; and an actuation device carried by the compressible member that is operatively connected to the internal switchable one-way valve such that placing the actuation device in an ON position places the internal switchable one-way valve in an active configuration so as to inhibit air from flowing out of the compressible portion and through the air flow control portion when the compressible portion is compressed and placing the actuation device in an OFF position places the one-way valve in an inactive configuration so as to allow air to flow out of the compressible portion and through the air flow control portion when the compressible portion is compressed.

[0067] Clause 22: The kit of clause 21 further comprising an external switchable one-way valve located at an outlet opening of the compressible portion, the external switchable one-way valve allowing air flow out of the compressible portion to the environment when the compressible portion is compressed.

[0068] Clause 23 : The kit of clause 22, wherein the external switchable one-way valve having an open configuration allowing air to escape from the compressible portion to the environment with the actuation device in the ON position, the external switchable one-way valve having a closed configuration with the actuation device in the OFF position inhibiting air flow through the second one-way valve when the compressible portion is compressed.

[0069] Clause 24: The kit of clause 23, wherein the external switchable one-way valve prevents air from entering the compressible portion with the actuation device in the ON position when the compressible portion is released, the internal switchable one-way valve allowing air to pass therethrough into the compressible portion thereby introducing a suction force to an insertion tube connected to the air flow control portion.

[0070] Clause 25: The kit of clause 23 or 24, wherein the actuation device comprises the external switchable one-way valve.

[0071] Clause 26: The kit of any of clauses 21-25 further comprising an elongated insertion tube that is communicatively coupled to the air flow control portion, the elongated insertion tube having an outer diameter sized to be received within an internal lumen of the drainage catheter.

[0072] Clause 27: The kit of clause 26, wherein the elongated insertion tube has a length that is greater than a length of the drainage catheter such that the elongated insertion tube can be inserted entirely through the drainage catheter. [0073] Clause 28: The kit of any of clauses 21-27 further comprising a saline delivery device configured for delivering saline into the compressible portion.

[0074] Clause 29: The kit of any of clauses 21-28, wherein the actuation device is operatively connected to the internal switchable one-way valve by a linkage.

[0075] Clause 30: The kit of any of clauses 21-29, wherein the compressible portion comprises a squeeze bulb.

[0076] It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments described herein without departing from the spirit and scope of the claimed subject matter. Thus it is intended that the specification cover the modifications and variations of the various embodiments described herein provided such modification and variations come within the scope of the appended claims and their equivalents.