Indwelling catheter system

Abstract

An indwelling pleural catheter system, the indwelling pleural catheter system comprising: an indwelling catheter device (2), the indwelling catheter device (2) comprising a catheter tube (7) and a connecting hub (10), the catheter tube (7) having a distal end (7A) configured to reside in an opening in the pleural cavity of a subject, the connecting hub (10) being fluidically connected to the proximal end (7B) of the catheter tube; a skin anchoring member (3), the skin anchoring member (3) being used to anchor the connecting hub (10) to the skin of the subject; and an optionally detachable ambulatory suction module (4), the detachable ambulatory suction module (4) being configured to be detachably attached to the connecting hub (10). The suction module (4) includes: a fluid inlet (19) configured to be fluidically coupled to a catheter tube (7) via a connecting hub (10); and a fluid outlet (20) configured to be detachably fluidically coupled to a pleural fluid drainage system (5) for draining pleural fluid via a detachable ambulatory suction module. The detachable ambulatory suction module is configured to apply negative pressure in the catheter tube when the pleural fluid drainage system is separated from the suction module. Treatment of pleural effusion using the system of the present invention is described. An indwelling catheter system for draining fluid from the peritoneal cavity and a method of treating ascites are also described.

Description

Technical Field

[0001] The present invention relates to an indwelling catheter system. The present invention also relates to a method of treating pleural effusion in a subject using an indwelling pleural catheter system. Background Art

[0002] A pleural effusion is a condition characterized by excess fluid accumulation within the pleural space, which is defined by the parietal and visceral membranes that surround the lungs and serve to lubricate and facilitate breathing. Normally, the pleural space contains a small amount of fluid. Excess fluid can cause chest pain, coughing, dyspnea, and orthopnea. This condition can be caused by many factors, including heart failure, pulmonary embolism, cirrhosis of the liver, and open-heart surgery. Other causes include pneumonia, cancer, kidney disease, and inflammatory diseases.

[0003] Common treatments for pleural effusions include thoracentesis (removal of fluid using a syringe), tube thoracostomy (removal of fluid using a chest tube that remains in place for several days), pleural drainage (removal of fluid using a long-term indwelling catheter), and pleurodesis. Pleurodesis involves chemically or mechanically irritating the pleura and has a 70%-90% success rate in preventing recurrence of pleural effusions. This treatment is highly invasive, requires prolonged hospitalization, and is contraindicated for patients with trapped lungs.

[0004] Insertion of an indwelling pleural catheter (IPC) offers a less invasive, ambulatory alternative to pleurodesis. However, IPC insertion does require an invasive tunneling procedure, involving making two incisions to secure the catheter under the skin. In addition, current IPCs are designed only to drain pleural fluid and do not contain a dedicated mechanism to prevent fluid reaccumulation. Therefore, many people who receive IPC treatment may use an IPC for up to a year.

[0005] It is an object of the present invention to overcome at least one of the above problems. Summary of the invention

[0006] The applicant solves the problems of the prior art by providing an indwelling pleural catheter system, which can perform pleural fluid drainage and also promote pleurodesis by extending the application of negative pressure therapy to the pleural cavity after the drainage step. Negative pressure is applied to the pleural cavity by using an indwelling catheter to pull the parietal membrane and the visceral membrane together, thereby promoting pleurodesis. The catheter system includes: a perforated catheter tube, which is configured to be placed in the pleural cavity using a connecting hub at the proximal end; and a detachable suction module, which is configured to be attached to the connecting hub, and the detachable suction module can be adjusted between three configurations. In the first configuration (drainage), the suction module provides a fluid connection between the connecting hub and the pressurized drainage system, and the pleural fluid is drained under pressure through the suction module. In the second configuration (negative pressure therapy), the drainage system is separated from the suction module, but the suction module maintains negative pressure and applies negative pressure in the catheter tube, thereby applying negative pressure therapy to the pleural cavity. The third configuration (resting) includes separating the suction module from the connection hub, thereby maintaining negative pressure within the catheter tube. In another aspect, the present invention provides a catheter system for draining fluid from a cavity defined by a parietal membrane and a visceral membrane (e.g., a pleural cavity or a peritoneal cavity) in a subject.

[0007] In a first aspect, the present invention provides an indwelling pleural catheter system, the indwelling catheter system comprising:

[0008] An indwelling catheter device comprising: a catheter tube having an ostial distal end configured to reside in a pleural cavity of a subject; and a connecting hub fluidly coupled to a proximal end of the catheter tube;

[0009] a skin anchoring member for anchoring the connection hub to the skin of a subject; and

[0010] A detachable walk-around suction module, the detachable walk-around suction module being configured for detachable attachment to a connection hub, and the detachable walk-around suction module comprising:

[0011] a fluid inlet configured for fluid coupling to a catheter tube via a connecting hub;

[0012] a fluid outlet configured for detachable fluid coupling to a pleural fluid drainage system for draining pleural fluid through a detachable ambulatory suction module; and

[0013] a generally actuatable closure member configured to close the fluid outlet when actuated,

[0014] Among them, the detachable ambulatory suction module is typically configured to apply negative pressure in the catheter tube when the closure is actuated.

[0015] Thus, the system of the present invention is configured to allow drainage of fluid from the pleural cavity in a first configuration (e.g., the drainage system is attached to the catheter via an ambulatory suction module, with the closure open), and application of a predetermined negative pressure therapy to the pleural cavity via the suction module in a second configuration (e.g., the drainage system is separated from the suction module, the closure in the suction module is closed to pressurize the suction module, and negative pressure is applied to the pleural cavity via the catheter). A third stationary configuration involves separation of the ambulatory suction module from the connection hub.

[0016] In any embodiment, the detachable ambulatory suction module includes a negative pressure chamber, wherein the fluid inlet is coupled to the fluid outlet via the negative pressure chamber fluid. Typically, the negative pressure chamber has a volume of at least 10cc, 15cc, 20cc, 25cc, or 30cc. This provides a simple and effective arrangement for negatively pressurizing the suction module and catheter to achieve negative pressure therapy of the pleural cavity.

[0017] In any embodiment, the actuable closure is configured to be closed by separating the pleural fluid drainage system from the detachable ambulatory suction module and to be opened when the pleural fluid drainage system and the detachable ambulatory suction module are attached. The drainage system may include a connector with a protruding conduit configured to protrude into the fluid outlet of the ambulatory suction module and open the closure. The closure may be, for example, a duckbill valve or any other type of valve, such as a cross valve or a disc valve or a combination of a cross valve and a disc valve.

[0018] In any embodiment, the detachable ambulatory suction module includes a relief valve configured to maintain a threshold negative pressure within the catheter tube when the pleural fluid drainage system is typically detached from the detachable ambulatory suction module. The relief valve can be configured to open when the pressure in the suction module exceeds the threshold negative pressure, thereby allowing air to enter the suction module until the threshold negative pressure is reached, and then the relief valve closes.

[0019] In any embodiment, the relief valve is configured to maintain a threshold negative pressure of 20 mmHg to 300 mmHg, 20 mmHg to 200 mmHg, or 20 mmHg to 140 mmHg in the catheter tube.

[0020] In any embodiment, the system is configured to monitor the pressure in the system, such as in an ambulatory suction module or a catheter tube, and to modify the negative pressure applied by the fluid drainage system in response to the monitored pressure. Typically, the ambulatory suction module or the catheter tube includes a pressure sensor. Typically, the system includes a processor operatively connected to the pressure sensor and the fluid drainage system (e.g., a pump connected to the fluid drainage system). Typically, the processor is configured to compare the pressure sensed by the pressure sensor with a reference pressure, and based on the comparison, actuate the fluid drainage system to modify the negative pressure applied by the fluid drainage system. In one embodiment, the system is configured to prevent the negative pressure in the system (e.g., in an ambulatory suction module or a catheter tube) from dropping below negative 140 mmHg (i.e., negative 141 mmHg, negative 142 mmHg, etc.). In one embodiment, the system is configured to maintain negative pressure in the ambulatory suction module or catheter tube at a pressure of negative 20 mmHg to negative 300 mmHg, negative 20 mmHg to negative 200 mmHg, or negative 20 mmHg to negative 140 mmHg.

[0021] The connection hub is typically disposed at the proximal end of the catheter tube and provides a hub for connecting the catheter tube to the ambulatory suction module. In any embodiment, the connection hub includes one or more closures configured to open when the detachable suction module is attached to the connection hub and to close when the connection hub is separated from the detachable suction module.

[0022] In any embodiment, the connecting hub includes at least two spaced apart closure members, one of which may be a duckbill valve.

[0023] In any embodiment, the fluid inlet of the suction module protrudes from a surface of the suction module and is configured to protrude into the connecting hub to open one or more closures.

[0024] In any embodiment, the skin anchoring member is separate from the connection hub and is configured for coupling with the connection hub. This allows the skin anchoring member to be attached to the skin before being attached to the connection hub. The coupling may be a snap fit coupling, a friction fit coupling, a threaded screw coupling or any other type of coupling.

[0025] In another embodiment, the skin anchoring member may be integrally formed with the connection hub and optionally configured to rotate relative to the connection hub.

[0026] In any embodiment, the skin anchoring member comprises a through lumen for receiving a fenestrated catheter tube.

[0027] In any embodiment, the system comprises: an outer housing configured to be attached (usually detachably attached) to a connection hub and comprising a connection hub surrounding housing having a through lumen for receiving the connection hub to expose the proximal end of the connection hub; and a base element configured to abut and preferably attach to the skin of a subject around the connection hub. This provides a seal around the connection hub, thereby protecting the connection hub, anchoring member and incision from contact with fluid or dust when the system is in use.

[0028] In any embodiment, the base of the cover comprises an adhesive element for attaching the base of the cover to the skin of the subject around the connection hub.The cover may comprise a releasable backing.

[0029] In any embodiment, the outer shell and the detachable suction module can be sized to facilitate coupling. For example, the detachable suction module can have a recessed base, and the outer shell can be sized to nest within the recessed base of the detachable suction module. The recessed base of the detachable suction module can be concave, and the outer shell can be convex.

[0030] In any embodiment, a portion of the fluid inlet of the detachable suction module protrudes from the recessed base of the detachable suction module. This allows the fluid inlet to protrude into the connection hub and establish fluid communication with the catheter through the connection hub.

[0031] In any embodiment, the indwelling pleural catheter system is configured to be assembled into a plurality of different configurations, the plurality of different configurations comprising:

[0032] a rest configuration in which the detachable suction module is not fluidly connected to the connection hub;

[0033] a drainage configuration in which the detachable suction module is fluidly connected to the connection hub and the pleural fluid drainage system, thereby allowing pleural fluid to be drained under pressure through the catheter device and the detachable ambulatory suction module; and

[0034] A negative pressure therapy configuration in which a detachable suction module is fluidly connected to the connection hub but not fluidly connected to the pleural fluid drainage system and is negatively pressurized.

[0035] In any embodiment, the separable suction module and the outer housing are configured to be coupled together. The coupling may be a snap-fit ​​coupling, a friction-fit coupling, a threaded screw coupling or any other type of coupling.

[0036] In any embodiment, the system includes a pleural fluid drainage system configured to be fluidically coupled to an outlet of a detachable suction module. The pleural fluid drainage system typically includes a pleural fluid collection container and a pump configured to draw pleural fluid from the pleural cavity into the collection container. In some embodiments, the drainage system lacks a pump and can be configured to draw pleural fluid from the pleural cavity by other means including gravity.

[0037] In any embodiment, the system comprises a needle, a cannula, and a peelable catheter / dilator.

[0038] In any embodiment, the connection hub and / or the cover includes a UV light configured to direct light onto the catheter tube and / or the skin. Typically, the cover includes a UV light configured to direct light onto the catheter tube and / or the skin.

[0039] In any embodiment, the connection hub and / or the cover includes an antimicrobial coating.

[0040] In any embodiment, the connecting hub and the skin anchoring member are configured for coupling together. The coupling may be a snap-fit ​​coupling, a friction-fit coupling, a threaded screw coupling, or any other type of coupling.

[0041] In a second aspect, the present invention provides an indwelling catheter system for draining fluid from a body cavity defined by a parietal membrane and a visceral membrane (e.g., a pleural cavity or a peritoneal cavity) of a subject, the indwelling catheter system comprising:

[0042] an indwelling catheter device comprising a catheter tube having an open distal end configured to reside in a cavity of a subject and a connecting hub disposed on a proximal end of the catheter tube and configured to fluidly couple the catheter tube with a fluid drainage device; and

[0043] A skin anchor member has a through lumen for receiving a catheter tube, an anchoring element configured for anchoring to the skin of a subject, and a coupling element configured to couple the skin anchor member to a connection hub.

[0044] In any embodiments, the system includes: an outer shell configured to attach (typically detachably attach) to a connection hub and including a connection hub surrounding shell having a through lumen for receiving the connection hub to expose a proximal end of the connection hub; and a base configured to abut and optionally attach to the subject's skin around the connection hub.

[0045] In any embodiment, the base of the cover includes an adhesive element for attaching the cover to the skin of the subject around the connection hub.The base may include a backing member for the adhesive element.

[0046] In another aspect, the present invention provides an ambulatory suction module suitable for use with an indwelling pleural or peritoneal catheter, the ambulatory suction module comprising a housing having:

[0047] a fluid inlet configured for detachable fluid coupling to a connection hub of an indwelling pleural catheter;

[0048] a fluid outlet configured for detachable fluid coupling to a pleural fluid drainage system; and

[0049] an actuatable closure member configured to close the fluid outlet when actuated,

[0050] Among them, the detachable ambulatory suction module is generally configured to apply negative pressure within the catheter tube when the closure member is actuated.

[0051] In any embodiment, the detachable walking type suction module comprises a negative pressure chamber, wherein the fluid inlet is connected to the fluid outlet by the negative pressure chamber fluid.Usually, the negative pressure chamber has a volume of at least 10cc, 15cc, 20cc, 25cc or 30cc.

[0052] In any embodiment, the actuable closure is configured to be closed by separating the pleural fluid drainage system from the detachable ambulatory suction module and to be opened when the pleural fluid drainage system and the detachable ambulatory suction module are attached. The drainage system may include a connector with a protruding conduit configured to protrude into the fluid inlet of the suction module and open the closure. The closure may be, for example, a duckbill valve or any other type of valve, such as a cross valve or a disc valve or a combination thereof.

[0053] In any embodiment, the detachable ambulatory suction module includes a relief valve configured to maintain a threshold negative pressure in the catheter tube when the pleural fluid drainage system is separated from the detachable ambulatory suction module. When the pressure in the suction module exceeds the threshold negative pressure, the relief valve opens.

[0054] In any embodiment, the relief valve is configured to maintain a threshold negative pressure within the catheter tube of 20 mm Hg to 300 mm Hg, 20 mm Hg to 200 mm Hg, or 20 mm Hg to 140 mm Hg.

[0055] In any embodiment, the system includes a pressure sensor for determining negative pressure in the system. The sensor can be located in the ambulatory suction module or in the catheter tube (or any other part of the system, such as a fluid conduit connecting the drainage system to the ambulatory suction module).

[0056] In another aspect, the invention provides an indwelling pleural catheter system according to the invention for use in treating a pleural effusion, typically a recurrent pleural effusion, in a subject.

[0057] In another aspect, the present invention provides an indwelling pleural catheter system according to the present invention for use in treating a pleural effusion, typically a recurrent pleural effusion, in a subject by forming a pleurodesis or facilitating the formation of a pleurodesis.

[0058] In another aspect, the present invention provides a method of treating a pleural effusion in a subject using an indwelling pleural catheter having an open-fenestrated distal end, the method comprising the steps of:

[0059] creating an incision in the subject's chest at the incision site;

[0060] inserting an indwelling pleural catheter through the incision into the subject's chest until the distal end of the catheter tube's opening is disposed in the pleural cavity and the proximal end of the catheter is disposed on the surface of the subject's chest; and

[0061] a pleural fluid drainage step, the pleural fluid drainage step comprising applying a first negative pressure to the pleural cavity through the pleural catheter to drain fluid from the pleural cavity,

[0062] Characterized in that the method comprises a negative pressure therapy step, which comprises applying a second negative pressure to the pleural cavity through the pleural catheter after the drainage step.

[0063] In any embodiment, the second negative pressure is less than or the same as the first negative pressure. In any embodiment, the second negative pressure applied to the catheter tube is 20 mmHg to 300 mmHg, 20 mmHg to 200 mmHg, or 20 mmHg to 140 mmHg.

[0064] In any embodiment, the method includes maintaining a negative pressure in the pleural cavity during the transition from the first negative pressure to the second negative pressure.

[0065] In any embodiment, the method includes the step of anchoring the proximal end of the catheter to the skin at the incision.

[0066] In any embodiment, the method includes a resting step during which the first negative pressure or the second negative pressure is not applied to the pleural catheter.

[0067] In any embodiment, the method includes the step of fluidly connecting a detachable suction module to a proximal end of an indwelling pleural catheter, wherein the detachable suction module is configured for detachably fluidly attaching to a pleural fluid drainage system configured to apply a first negative pressure to the pleural catheter, wherein the draining step includes fluidly attaching the detachable suction module to the pleural fluid drainage system.

[0068] In any embodiment, the detachable suction module is configured to apply a second negative pressure to the pleural catheter when the detachable suction module is fluidly separated from the pleural fluid drainage system, wherein the negative pressure therapy step includes fluidly separating the pleural fluid drainage system from the detachable suction module.

[0069] In any embodiment, the stationary step includes separating the detachable suction module from the pleural catheter.

[0070] In another aspect, the present invention provides a method for treating pleural effusion in a subject using an indwelling pleural catheter system according to the present invention, the method comprising the steps of:

[0071] creating an incision in the subject's chest at the incision site;

[0072] inserting a catheter tube of an indwelling catheter device through the incision into the chest of the subject until the fenestrated distal end of the catheter tube is disposed in the pleural cavity and the connecting hub is disposed on the surface of the chest at the point of the incision;

[0073] anchoring the connection hub to the subject's skin with a skin anchoring member;

[0074] draining pleural fluid from the pleural cavity under negative pressure by coupling the connection hub and the detachable ambulatory suction module to the pleural fluid drainage system and actuating the pleural fluid drainage system; and

[0075] Negative pressure therapy is applied to the pleural space through the catheter tube by disconnecting the pleural fluid drainage system from the detachable ambulatory suction module and applying negative pressure applied by the detachable ambulatory suction module.

[0076] In any embodiment, the method includes the step of coupling the outer housing to the connection hub prior to coupling the connection hub to the detachable ambulatory suction module.

[0077] In any embodiment, the method includes a stationary step, which includes separating the detachable ambulatory suction module from the connection hub to maintain negative pressure in the catheter tube.

[0078] In any embodiment, the method comprises inserting a catheter tube through a single lumen in the chest.

[0079] In any embodiment, the skin anchoring member is separate from the connecting hub and the skin anchoring member is configured to be coupled to the connecting hub, and the method includes the steps of anchoring the skin anchoring member to the skin of the subject at the incision point, inserting the catheter tube into the chest of the subject, and coupling the connecting hub to the anchored skin anchoring member.

[0080] In any embodiment, the skin anchoring member includes a central orifice for receiving a catheter tube, and the method includes the steps of anchoring the skin anchoring member to the skin so that the central orifice of the skin anchoring member covers the incision point in the subject's chest; thereby performing the step of inserting the catheter tube into the subject's chest through the central orifice of the skin anchoring member.

[0081] In any embodiment, the draining step, the negative pressure therapy step, and the resting step are performed at least once every 48 hours, 24 hours, 18 hours, or 12 hours.

[0082] In any embodiment, the negative pressure therapy step lasts from 1 hour to 24 hours, from 1 hour to 12 hours, from 1 hour to 8 hours, from 1 hour to 5 hours, from 1 hour to 3 hours, from 1 hour to 2 hours, or from 0.5 hour to 1 hour.

[0083] In any embodiment, the step of inserting the catheter tube into the pleural cavity and anchoring the connecting hub comprises the following steps:

[0084] anchoring the skin anchoring member at the incision site;

[0085] A needle and introducer are inserted through the incision and through the chest wall into the pleural space;

[0086] The needle is withdrawn, thereby leaving the introducer in place;

[0087] Advance the guidewire through the introducer and into the pleural space;

[0088] Remove the introducer from the guidewire and leave the guidewire in place;

[0089] A peelable catheter / dilator is advanced over the guidewire into the pleural space;

[0090] Remove the dilator portion of the catheter / dilator and the guidewire;

[0091] advancing the catheter through the peelable catheter until the connecting hub abuts the peelable catheter;

[0092] Removing the peelable catheter; and

[0093] A connecting hub is coupled to the skin anchoring member.

[0094] In another aspect, the present invention provides a method of treating a pleural effusion in a subject, the method comprising the step of promoting pleurodesis by applying negative pressure to the pleural cavity of the subject via an indwelling pleural catheter for a therapeutic period of time.

[0095] Typically, the method includes draining pleural fluid from the pleural space for a period of time prior to the negative pressure therapy step.

[0096] In one embodiment, the negative pressure therapy step comprises applying a negative pressure of 20 mmHg to 300 mmHg, 20 mmHg to 200 mmHg, or 20 mmHg to 140 mmHg to the pleural cavity of the subject through an indwelling pleural catheter.

[0097] In one embodiment, the negative pressure therapy step is performed for 1 hour to 24 hours, 1 hour to 12 hours, 1 hour to 8 hours, 1 hour to 5 hours, 1 hour to 3 hours, 1 hour to 2 hours, or 0.5 hour to 1 hour.

[0098] In one embodiment, the method comprises a plurality of negative pressure treatments, and optionally a plurality of drainage treatments.

[0099] In another aspect, the present invention provides a method of treating a disease associated with fluid accumulation in a body cavity defined by parietal and visceral membranes of a subject, such as ascites or pleural effusion, using the system of the present invention, the method comprising the steps of:

[0100] creating an incision in the abdomen or chest of the subject at the incision site;

[0101] inserting a catheter tube of an indwelling catheter device through the incision into the abdomen or chest of the subject until the open distal end of the catheter tube is disposed in the body cavity and the connecting hub is disposed on the surface of the skin at the incision point;

[0102] anchoring the connection hub to the subject's skin with a skin anchoring member; and

[0103] Fluid is drained from the cavity under negative pressure by coupling the connection hub to the fluid drainage system and actuating the fluid drainage system.

[0104] Further aspects and preferred embodiments of the invention are defined and described in the further claims set out below. BRIEF DESCRIPTION OF THE DRAWINGS

[0105] Figure 1 is an illustration of an indwelling pleural catheter system according to the present invention, showing an indwelling catheter device (catheter tube and connecting hub), a skin anchoring member, a cover for the connecting hub, a detachable ambulatory suction module, and a pleural fluid drainage module.

[0106] Figure 2 is formed Figure 1 A stereoscopic view of a skin anchoring member that is a portion of a system.

[0107] Figure 3 is formed Figure 1 A plan view of an indwelling catheter device that is part of a system and includes a catheter tube having an open distal end configured to reside in a pleural cavity of a subject and a connecting hub.

[0108] Figure 4 It is used to form Figure 1 A perspective view of a detachable outer housing of a connecting hub that is part of a system.

[0109] Figure 5 It is formed from Figure 1 A perspective view of a part of the system, viewed from below, of the ambulatory suction module.

[0110] Figure 6 Illustration of the connector used to connect the pleural fluid drainage system to the ambulatory suction module.

[0111] Figure 7 The ambulatory suction module is illustrated to be coupled and fluidly connected to a connection hub and an external housing.

[0112] Figure 8 yes Figure 7 Cross-sectional view of the walk-around suction module.

[0113] Fig. 9 yes Figure 7 Cross-sectional view of the connecting hub, conduit and outer housing.

[0114] FIG. 10A to FIG. 10K The use of the system of the present invention to treat pleural effusion is shown, wherein:

[0115] Fig. 10A A patient is shown with an ambulatory suction module and pleural fluid drainage system positioned on a table and fluidly connected, wherein an indwelling pleural catheter device is inserted into the pleural cavity along with a distal catheter tube (not shown), and a connecting hub is anchored to the patient's skin (not shown), and an external housing is coupled to the connecting hub (not shown);

[0116] Fig. 10B The patient is shown removing the sanitary cap from the outer housing;

[0117] Fig. 10C A patient is shown coupling a suction module to a connection hub;

[0118] Fig. 10D A patient-actuated drainage pump is shown to drain fluid from the pleural cavity through a pleural catheter and an ambulatory suction module;

[0119] Fig. 10E illustrates a drainage step in which the patient is in a seated position while the drainage step is performed;

[0120] Fig.10F The patient is shown disconnecting the connector of the pleural fluid drainage system from the ambulatory suction module to terminate the drainage step and initiate the negative pressure therapy step;

[0121] Figure 10G A negative pressure therapy step is illustrated in which an ambulatory suction module remains fluidly connected to a connection hub to apply negative pressure to the pleural cavity to facilitate pleurodesis. During this step, as illustrated, the patient may be ambulatory;

[0122] Fig. 10H The patient is shown separating the ambulatory suction module from the connection hub to terminate the negative pressure therapy step and initiate the resting step. Upon separation, the valve in the connection hub is closed to fluid-tightly seal the indwelling pleural catheter.

[0123] Fig.10I A patient is shown with exposed connection hub and outer housing and a hygiene cap on a table;

[0124] Fig.10J The patient is shown applying the sanitary cap to the outer surface of the connecting hub and the outer housing; and

[0125] Figure 10K The patient during the stationary step is shown with a sanitary cap covering the outer surface of the connecting hub and the outer housing. Although the patient is shown sitting, the patient may also be walking during this step. DETAILED DESCRIPTION

[0126] All publications, patents, patent applications, and other references mentioned herein are incorporated by reference in their entirety for all purposes to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference and was set forth in its entirety.

[0127] Definitions and general preferences

[0128] As used herein, and unless otherwise specifically indicated, the following terms are intended to have the following meanings, in addition to any broader (or narrower) meanings they may have in the art:

[0129] Unless the context requires otherwise, the use of the singular herein shall be understood to include the plural, and vice versa. The term "a" or "an" used with respect to an entity shall be understood to refer to one or more of that entity. Thus, the terms "a" (or "an"), "one or more" and "at least one" are used interchangeably herein.

[0130] As used herein, the term "include" or variations thereof, such as "comprises" or "having" should be understood to mean including any recited whole (e.g., features, elements, characteristics, properties, methods / process steps, or limitations) or groups of wholes (e.g., features, elements, characteristics, properties, methods / process steps, or limitations), but not excluding any other whole or groups of wholes. Thus, as used herein, the term "having" is inclusive or open-ended and does not exclude additional unrecited wholes or methods / process steps.

[0131] As used herein, the term "disease" is used to define any abnormal condition that impairs physiological function and is associated with specific symptoms. The term is used broadly to cover any disorder, ailment, abnormality, pathology, condition, physical condition or syndrome in which physiological function is impaired, regardless of the nature of the etiology (or whether an etiological basis for the disease has actually been established). Thus, it includes physical conditions caused by infection, trauma, injury, surgery, radiation ablation, age, poisoning or nutritional deficiencies.

[0132] As used herein, the term "treatment" or "treatment" refers to an intervention (e.g., administering a drug to a subject) that cures, improves or alleviates disease symptoms or eliminates its cause (or alleviates the effects of its cause) (e.g., reduces accumulation of pathological levels of lysosomal enzymes). In this case, the term is used synonymously with the term "therapy."

[0133] In addition, the term "treatment" or "treatment" refers to an intervention (e.g., administering medicine to a subject) that prevents or delays the occurrence or development of a disease in a population receiving treatment, or reduces (or eradicates) the incidence of a disease. In this case, the term treatment is used synonymously with the term "prevention." The therapeutic outcome in this case includes eliminating or alleviating symptoms, alleviating pain or discomfort, prolonging survival, improving mobility, and other signs of clinical improvement. The result of treatment is not necessarily a complete cure. Improvements can be observed in biological / molecular markers, clinical or observational improvements. In a preferred embodiment, the method of the present invention is applicable to humans, large competition animals (horses, camels, dogs), and domestic companion animals (cats and dogs).

[0134] In the context of treatment and effective dose as defined above, the term subject (which shall be understood to include "individual", "animal", "patient" or "mammal" where the context permits) defines any subject, particularly a mammalian subject, for whom treatment is provided. Mammalian subjects include, but are not limited to, humans, domestic animals, farm animals, zoo animals, sports animals, pet animals, such as dogs, cats, guinea pigs, rabbits, mice, rats, horses, camels, bison, cattle, cows; primates, such as apes, monkeys, gorillas and chimpanzees; canines, such as dogs and wolves; felines, such as cats, lions and tigers; equines, such as horses, donkeys and zebras; food animals, such as cattle, pigs and sheep; ungulates, such as deer and giraffes; and rodents, such as mice, rats, hamsters and guinea pigs. In a preferred embodiment, the subject is a human. As used herein, the term "equine" refers to equine mammals, including horses, donkeys, wild donkeys, racing donkeys and zebras.

[0135] "Pleural effusion" refers to a condition characterized by excess fluid accumulation in the pleural space, which is defined by the parietal and visceral membranes that surround the lungs and serve to lubricate and facilitate breathing. Normally, the pleural space contains a small amount of fluid. Excess fluid can cause chest pain, coughing, difficulty breathing, and orthopnea. This condition can be caused by many factors, including heart failure, pulmonary embolism, cirrhosis of the liver, and open-heart surgery. Other causes include pneumonia, cancer, kidney disease, and inflammatory diseases.

[0136] "Indwelling catheter device" refers to a catheter suitable for treating a condition characterized by accumulation of fluid in a body cavity such as the pleural or peritoneal cavity, such as pleural effusion or ascites, having a catheter tube length with a distal end having an opening and a connector such as a connecting hub at the proximal end that is fluidly connected to the catheter tube. In the case of an indwelling pleural catheter, the catheter tube is sized to pass through the chest wall and into and along the pleural cavity. The opening (orifice) in the catheter tube is usually sized to allow fluid to be drained from the pleural cavity through the tube under pressure.

[0137] A "connection hub" refers to the proximal portion of a catheter device that is configured to be fluidly coupled to a detachable ambulatory suction module (or in some embodiments, a fluid drainage device), and typically also to anchor the catheter device to the patient's skin by attachment to a separate anchoring member that is itself attached to the patient's skin (although in one embodiment, the anchoring member may form part of the connection hub). The connection hub includes one or more closure members (e.g., one or more valves) that are configured to close when the ambulatory suction module is disconnected from the connection hub, thereby decompressing the catheter tube. The connection hub is configured to engage with the suction module or cover in any manner, such as by a snap fit, friction fit, twist-lock engagement mechanism. In one embodiment, the connection hub includes a base element and a through lumen. The base may include a structure that allows the connection hub to be coupled to the anchoring member.

[0138] "Skin anchor member" refers to a device configured to be anchored to the skin and, in one embodiment, coupled to a connection hub. In one embodiment, it includes a base and a helical anchor for inserting into and under the skin by rotating the anchor member. Typically, the base includes a through hole through which the catheter tube is advanced into the pleural cavity. The base may include a structure for coupling with a connection hub. In one embodiment, the skin anchor member includes an upper medical article attachment portion and a lower insertion portion, the lower insertion portion being used to fix the anchor member subcutaneously to a subject, wherein the insertion portion includes a helical anchor substantially disposed in a single plane. In one embodiment, the helical anchor defines an Archimedean spiral shape, such as the helical anchor being disposed in a single plane. Preferably, the helical anchor extends laterally outward from the medical article attachment portion. In one embodiment, the helical anchor includes at least one full turn. Preferably, the helical anchor is flexible. Preferably, the helical anchor includes a free insertion end for insertion into the subject. In one embodiment, the medical anchoring device also includes a skin receiving gap between the medical article attachment portion and the helical anchor. Preferably, the gap comprises a slot-shaped gap. Suitably, the gap is defined by a spacer arm between the medical article attachment portion and the spiral anchor. More preferably, the spacer arm is configured to define a curved skin abutment surface. In one embodiment, the curved skin abutment surface comprises a concave skin abutment surface. Preferably, the spacer arm comprises a non-flexible spacer arm. Suitably, the spiral anchor is attached to the medical article attachment portion at an end of the medical article attachment portion adjacent to the medical article attachment portion. In one embodiment, the medical article attachment portion comprises a platform. Preferably, the platform comprises a substantially cylindrical platform. More preferably, the platform comprises a lumen. The cylindrical platform may have a cross-section that is substantially circular, oval, square, rectangular or any other shape. In one embodiment, the medical article attachment portion comprises an adhesive for adhering the attachment portion to the subject around the incision. Most preferably, the lumen comprises a top opening and a bottom opening. Advantageously, the platform comprises a medical article mounting member. Preferably, the medical article mounting member comprises a top medical article mounted at the top opening. Alternatively or additionally, the medical article mounting member comprises a bottom medical article mounted at the bottom opening. In one embodiment, the top medical item mount and / or the bottom medical item mount include threads.Other forms of mounts may be used, such as, for example, recessed grooves, friction fit mounts, adhesive mounts, and clips or clamps.

[0139] An "external housing" (or "pleural port") refers to a housing configured to couple with a connection hub and having a through lumen for receiving the connection hub such that a top surface of the connection hub is exposed at the top of the external housing and thereby provides access to a fluid inlet of a suction module. The external housing may be sized to match an ambulatory suction module.

[0140] A "detachable ambulatory suction module" refers to a device that is detachably attached to a connection hub (optionally via an external housing), the device having an inlet for fluid connection with the connection hub, and an outlet for connection to a pleural fluid drainage system, and a fluid conduit that fluidly connects the inlet and the outlet, the device typically including a negative pressure chamber configured to maintain a negative pressure in the module when the module is disconnected from the fluid drainage system and sealed with a closure such as a valve. The negative pressure chamber typically has a volume of at least 20cc to 30cc. The module is configured to apply a negative pressure in the catheter device when the catheter device is disconnected from the pleural fluid drainage system. The suction module also includes a device for controlling the negative pressure applied by the suction module when the suction module is disconnected from the fluid drainage system, in one embodiment, the device is a valve such as a relief valve, which is configured to dissipate the negative pressure in the suction module until a target (threshold) negative pressure is obtained (e.g., air is allowed to enter the suction module until a threshold negative pressure is reached). In one embodiment, the device (eg, the relief valve) is adjustable to vary the target pressure depending on the desired negative pressure therapy.

[0141] "Pleural fluid drainage system" refers to a system that is configured to be attached to a detachable suction module, and when they are connected, pleural fluid is extracted under pressure through an indwelling catheter device and a suction module. The system of the present invention may include a pleural fluid drainage system. The system typically includes a pump or other devices (such as gravity-fed drainage or negative pressure systems) for draining fluid from the cavity through an indwelling catheter tube, a fluid collection container, and an associated tube. In one embodiment, the pleural fluid drainage system is configured to perform pleural fluid drainage under a negative pressure (e.g., -120mmHg) greater than the target negative pressure (e.g., -90mmHg) used for negative pressure therapy. The pleural fluid drainage system includes a conduit connected to the fluid of the ambulatory suction module via a connector element. In one embodiment, the connector element includes a protruding fluid conduit that is configured to protrude into the fluid outlet of the ambulatory suction module and establish a fluid connection therewith. In one embodiment, the fluid outlet comprises a closure member (eg, a duckbill valve, a cross valve, a disc valve, or a combination thereof) configured to be opened by a protruding fluid conduit of the connector element.

[0142] "Ambulatory" as used in connection with the detachable suction module refers to a device that can be worn by the patient while allowing the patient to ambulate; in other words, the suction module is wearable and does not require the patient to be still, sitting, or lying in bed for use.

[0143] "Target negative pressure" refers to a negative pressure that is sufficient to promote pleurodesis in the patient's pleural cavity while being safe and comfortable for the patient. It will be understood that the target negative pressure varies depending on the patient's clinical condition, age, and health, but the target negative pressure is typically in the range of 20 mmHg to 300 mmHg, 20 mm Hg to 200 mmHg, or 20 mmHg to 140 mmHg. In one embodiment, the target negative pressure within the catheter tube is 20 mmHg to 40 mmHg, 20 mmHg to 60 mmHg, 20 mmHg to 80 mmHg, 20 mmHg to 100 mmHg, 20 mmHg to 140 mmHg, 20 mmHg to 200 mmHg, 20 mmHg to 300 mmHg, 40 mmHg to 60 mmHg, 40 mmHg to 80 mmHg, 40 mmHg to 100 mmHg, 60 mmHg to 80 mmHg, 60 mmHg to 120 mmHg, 80 mmHg to 100 mmHg, 80 mmHg to 120 mmHg, 80 mmHg to 140 mmHg, 100 mmHg to 120 mmHg, 100 mmHg to 140 mmHg, 120 mmHg to 140 mmHg.

[0144] Example

[0145] The present invention will now be described with reference to specific examples. These examples are exemplary only and are for illustrative purposes only: they are not intended to limit the scope of the claimed patent or the described invention in any way. These examples constitute the best mode currently considered for practicing the present invention.

[0146] System components

[0147] Reference Figure 1 , illustrates an indwelling catheter system according to one embodiment of the present invention in an exploded view. The system, generally indicated by reference numeral 1, includes an indwelling catheter device 2 having a proximal connection hub 10, an anchoring member 3 (shown before coupling with the connection hub), a detachable ambulatory suction module 4, and an external cover 11 (pleural port) for the proximal connection hub 10, and a pleural fluid drainage system 5. The pleural fluid drainage system 5 includes a container 6 with a pump or negative pressure system (not shown) and a conduit 23 with a fluid connector 26, which is used to provide a fluid connection between the container 6 and the ambulatory suction module 4 for pressurizing and draining pleural fluid from the pleural cavity through the catheter device and the suction module and into the container 6.

[0148] Now refer to Figures 2 to 9 , the components of this embodiment of the system of the present invention will be described in more detail.

[0149] Reference Figure 2The anchor member 3 is a helical anchor having a base 12 and a helical member 13 formed of a suitable elastomer such as santoprene, the helical member 13 having a leading edge for insertion into an incision in the skin, whereby rotation of the anchor member embeds the helical member into the skin. The base 12 includes a through lumen 14 for receiving the catheter device 2 and includes an annular shoulder 28 in the through lumen for coupling with the connecting hub 10.

[0150] Reference Figure 3 , the indwelling catheter device 2 includes a silicone catheter tube 7 having a distal end 7A including a plurality of openings 8 and a proximal end 7B terminating in a connecting hub 10. The base 9 of the connecting hub 10 includes an annular shoulder for twist-lock or push-lock coupling with the through lumen 14 of the anchor member 3. The connecting hub also includes two spaced-apart valves, as described in more detail below.

[0151] Reference Figure 4 , the outer housing 11 comprises: a dome-shaped housing having a through lumen 15 sized to receive the connection hub 10, so that when the outer housing and the connection hub are coupled, the proximal end 10A of the connection hub 10 sits substantially flush with the upper surface of the outer housing; and an annular base element 21 configured to abut the skin around the anchoring member. The base element 21 includes an adhesive element (not shown) for securing the base element to the subject's skin around the anchoring member 3. The purpose of the cover is twofold: to protect the connection hub and the cutout; and to provide an upper surface that facilitates the mating of the ambulatory suction module 4 and the connection hub 10.

[0152] Reference Figure 5 , Figure 7 and Figure 8The detachable ambulatory suction module 4 comprises a housing 16 having a flat top 17; and a concave lower side 18, which is sized to cooperate with the convex top of the outer housing 11 of the connection hub 10. The housing 16 defines a fluid passage through the module from a protruding fluid inlet 19 protruding from the concave lower side 18 to a fluid outlet 20 disposed on the periphery of the module. The fluid passage comprises a negative pressure chamber 24 having a volume of approximately 30cc. The fluid outlet 20 comprises a closure in the form of a clamp 25, which is configured to close the fluid outlet when the fluid connector 26 of the pleural fluid drainage system 5 is disconnected from the fluid outlet 20, so as to close the outlet and fluid-seal the module. A cross valve or a disc valve (or a combination of a cross valve and a disc valve) may also be used as a closure. The sealing of the fluid outlet 20 combined with the pressure in the negative pressure chamber 24 causes the module to be negatively pressurized and applies negative pressure to the pleural cavity through the catheter device 2. Module 4 also includes a relief valve 22, which is configured to maintain a threshold negative pressure in the module, and in the present embodiment, the threshold negative pressure is a negative pressure of 90mmHg. Additionally or alternatively, the ambulatory suction module 4 or the catheter tube may include a pressure sensor. The pressure sensor may be operatively coupled to a liquid drainage system 5 (e.g., a pump coupled to a drainage system) to modify the negative pressure applied by the fluid drainage system based on a pressure reading obtained by the pressure sensor. The sensor and the drainage system may be operatively coupled to a processor, whereby the processor is configured to receive a pressure reading from the pressure sensor, compare the pressure reading with a reference pressure, and modify the negative pressure applied by the fluid drainage system based on a comparison. In one embodiment, the system is configured to prevent the negative pressure in the system and particularly the negative pressure in the ambulatory suction module from dropping below negative 140mmHg (i.e., negative 141mmHg, negative 142mmHg, etc.). In one embodiment, the system is configured to maintain negative pressure in the ambulatory suction module or catheter tube at a pressure of negative 20 mmHg to negative 300 mmHg, negative 20 mmHg to negative 200 mmHg, or negative 20 mmHg to negative 140 mmHg.

[0153] Reference Figure 6 and Figure 8 The fluid connector 26 of the pleural fluid drainage system includes a protruding tube 29, which protrudes into the fluid outlet 20 when the connector 26 and the ambulatory suction module 4 are connected, thereby forcing the clamp 25 to open to open the fluid outlet of the suction module 4 and allow fluid to be drained from the pleural cavity through the catheter device and the suction module 4.

[0154] Fig. 9A connecting hub 10, an anchoring member 3 coupled to the connecting hub, and an outer housing 11 coupled to the connecting hub are shown, wherein the proximal end 10A of the connecting hub is exposed. The connecting hub 10 includes a through-conduit having two spaced-apart valves, a cross valve 30 and a duckbill valve 31. These valves are biased to a closed position to fluidly seal the connecting hub and prevent fluid passage into the catheter tube, and prevent undesired fluid passage out of the pleural cavity.

[0155] Reference Figure 8 and Fig. 9 , illustrates the connection hub 10 and the ambulatory suction module 4 before coupling, wherein the suction module 4 is positioned above the connection hub 10. When the suction module 4 is moved into engagement with the connection hub, the fluid inlet 19 protrudes into the exposed proximal end 10A of the connection hub 10, thereby pushing open valves 30 and 31 to establish fluid communication between the ambulatory suction module and the pleural catheter. Similarly, when the suction module 4 and the connection hub 10 are disconnected, the valve closes to fluid-seal the connection hub and prevent air and fluid passages from entering the catheter tube.

[0156] Treatment of pleural effusion

[0157] The use of the system of the present invention will refer to FIG. 10A to FIG. 10K To explain.

[0158] First refer to Fig. 10A , illustrates a patient after placement of an indwelling catheter and anchoring member, wherein the connection hub and cover are placed on the surface of the patient's chest and covered by a sanitary cap 32. At this stage, the valves 30, 31 in the connection hub are closed. The suction module 4 and the drainage system 5 are shown in a fluid connection configuration on a table behind the patient. The drainage system includes a pump (not shown) and a controller 33 in the conduit 23. Fig. 10B The patient is shown removing the hygienic cap 32 from the outer housing.

[0159] Fig. 10C The patient is shown coupling the suction module 4 to the connection hub. This step is facilitated by the convex shape of the outer housing matching the concave shape of the underside of the suction module. The coupling opens the valves 30, 31 in the connection hub and establishes fluid communication between the pleural catheter and the suction module 4. At this stage, the pump of the drainage system has not yet been actuated.

[0160] Fig. 10D The patient is shown actuating the pump of the drainage system via controller 33 to start the drainage step and drain fluid from the pleural cavity through the pleural catheter and suction module 4 and into the container 6 .

[0161] Fig. 10E The drainage steps are illustrated wherein the patient is in a seated position while the drainage steps are performed.

[0162] like Fig.10F As shown in , when the drainage step has been completed, the patient separates the connector 26 of the pleural fluid drainage system from the ambulatory suction module 4 to terminate the drainage step and start the negative pressure therapy step. When the connector 26 is separated from the outlet of the suction module 4, the valve in the fluid outlet of the suction module is closed, thereby maintaining the negative pressure in the suction module due to the negative pressure chamber in the suction module. The negative pressure is controlled by a relief valve in the suction module to maintain the negative pressure below a threshold negative pressure during the duration of the negative pressure therapy step, wherein the relief valve is designed to dissipate the negative pressure by allowing air to enter the suction module when the pressure is too low.

[0163] Figure 10G A negative pressure therapy step is illustrated in which an ambulatory suction module remains fluidly connected to a connection hub to apply negative pressure to the pleural cavity to facilitate pleurodesis. During this step, as illustrated, the patient may be ambulatory;

[0164] Fig. 10H The patient is shown separating the ambulatory suction module 4 from the connection hub 10 to terminate the negative pressure therapy step and start the rest step. During separation, the valve in the connection hub is closed to fluid-tightly seal the indwelling pleural catheter.

[0165] Fig.10I A patient is shown with the connection hub 10 and the outer housing 11 exposed and a hygiene cap 32 on a table, and Fig.10J The patient is shown applying the sanitary cap to the outer surface of the connecting hub and the outer housing; and

[0166] Figure 10K The patient is shown during a stationary step, with the hygienic cap 32 covering the outer surface of the connecting hub and the outer housing. Although the patient is shown sitting, the patient may also be walking during this step.

[0167] Placement of indwelling pleural effusion catheter

[0168] The placement and assembly of the system of the present invention is now described in more detail.An initial incision is made in the subject's chest, typically on one side of the chest, and the leading edge of the helical anchor is inserted into the incision, where it is rotated to embed the anchor beneath the skin.

[0169] Then, the introducer and needle / syringe are passed through the hole in the spiral anchor and through the intercostal muscles and inserted into the pleural cavity. Imaging such as ultrasound can be used to guide the catheter to be safely advanced into the pleural cavity. Then, the needle / syringe is removed, and the introducer is left in place. Then, the guide wire is advanced into the pleural cavity through the introducer, and then the needle / syringe is removed.

[0170] The peelable catheter / dilator is then advanced over the guidewire into the pleural cavity. After the dilator and guidewire are removed, the surgeon's thumb is placed over the outlet port at the end of the peelable catheter to prevent pleural fluid from draining.

[0171] The distal end of the catheter device is then advanced through the peelable catheter until the connection hub abuts the peelable catheter, after which the peelable catheter is withdrawn and the connector is coupled to the helical anchor.

[0172] An outer housing (pleural port) having a through lumen is then positioned over the connection hub with the proximal end of the connection hub exposed through the lumen, and the base of the outer housing is secured to the subject's skin around the anchoring member.

[0173] Overview

[0174] The above-described embodiment employs an outer shell 11 that surrounds the connection hub and covers the incision site, and the outer shell 11 also covers the connection hub by a cover configured to cooperate with the suction module 4. It will be understood that in some embodiments, a cover is not required, and the connection hub can be sized to cover the incision site and provide a surface that is convenient for cooperation with the suction module. Similarly, in the above-described embodiment, the anchoring member 3 and the connection hub 10 are separate elements configured to be connected together when the anchoring member has been anchored to the patient's skin. It will be understood that in some embodiments, the anchoring member can form a part of the connection hub and can be configured for anchoring rotation relative to the connection hub.

[0175] Equivalent solution

[0176] The foregoing description describes in detail the currently preferred embodiments of the present invention. It is expected that those skilled in the art will think of many modifications and variations of the currently preferred implementation in practice when considering these descriptions. These modifications and variations are intended to be included in the claims attached hereto.

Claims

1. An indwelling catheter system for draining fluid from a body cavity defined by a parietal membrane and a visceral membrane of a subject, comprising: An indwelling catheter device (2) comprising a catheter tube (7) having an open distal end (7A) configured to reside in a cavity of the subject, and a connecting hub (10) disposed on a proximal end (7B) of the catheter tube and configured to fluidically couple the catheter tube to a fluid drainage system; as well as a skin anchoring member (3) having a through lumen (14) for receiving the catheter tube, an anchoring member (13) configured to anchor to the skin of the subject, and a coupling element configured to couple the skin anchoring member to the connection hub (10), Characterized in that the indwelling catheter system further comprises: a detachable walk-around suction module (4), the detachable walk-around suction module (4) being configured to be detachably attached to the connection hub (10); a fluid inlet (19) fluidly coupled to the catheter tube (7) via the connecting hub (10); a fluid outlet (20) configured to be detachably fluidly coupled to a fluid drainage system (5) for draining pleural fluid through the detachable ambulatory suction module; and an actuatable closure member (25) configured to close the fluid outlet when actuated, wherein the detachable ambulatory suction module is configured to apply negative pressure in the catheter tube upon actuation of the actuatable closure member; wherein the detachable ambulatory suction module (4) comprises a negative pressure chamber (24), wherein the fluid inlet (19) is fluidically coupled to the fluid outlet (20) via the negative pressure chamber; And wherein the negative pressure chamber is configured to maintain negative pressure in the detachable ambulatory suction module when the detachable ambulatory suction module is disconnected from the fluid drainage system and the actuatable closure is closed.

2. The indwelling catheter system according to claim 1, wherein: The fenestrated distal end (7A) of the catheter tube is configured to reside in the pleural or peritoneal cavity of a subject.

3. The indwelling catheter system according to claim 1, wherein: The actuatable closure (25) is configured to be closed by separating the fluid drainage system from the detachable ambulatory suction module and to be opened when the fluid drainage system and the detachable ambulatory suction module are attached.

4. The indwelling catheter system according to claim 1 or 3, wherein: The negative pressure chamber has a volume of at least 10cc, 15cc, 20cc, 25cc or 30cc.

5. The indwelling catheter system according to claim 1 or 3, wherein: The connection hub (10) comprises a valve, which is configured to open when the connection hub is attached to the detachable ambulatory suction module (4) and to close when the connection hub is separated from the detachable ambulatory suction module.

6. The indwelling catheter system according to claim 1 or 3, wherein: The system includes an outer shell (11) configured to be detachably attached to the connection hub (10) and includes a connection hub surrounding shell having a through lumen (15) for receiving the connection hub to expose the proximal end (10A) of the connection hub; and a base element (21) configured to abut the skin of the subject around the skin anchoring member (3).

7. The indwelling catheter system according to claim 6, wherein: The base element (21) of the outer housing (11) comprises an adhesive dressing for attaching the outer housing to the skin of the subject.

8. The indwelling catheter system according to claim 6, wherein: The detachable ambulatory suction module (4) has a recessed base (18), and the outer housing (11) has an upper surface sized to nest within the recessed base of the detachable ambulatory suction module (4).

9. The indwelling catheter system according to claim 8, wherein: The fluid inlet (19) of the detachable walk-around suction module (4) protrudes from the recessed base (18) of the detachable walk-around suction module (4).

10. The indwelling catheter system of claim 1 or 3, configured to be assembled into a plurality of different configurations, the plurality of different configurations comprising: a stationary configuration in which the detachable walk-around suction module (4) is not fluidically connected to the connection hub (10); a drainage configuration in which the detachable ambulatory suction module (4) is fluidically connected to the connection hub (10) and the fluid drainage system (5), thereby allowing fluid to be drained under pressure through the catheter device (2) and the detachable ambulatory suction module (4); and / or A negative pressure therapy configuration in which the detachable ambulatory suction module (4) is fluidly connected to the connection hub (10) but not fluidly connected to the fluid drainage system (5), and is negatively pressurized.

11. The indwelling catheter system according to claim 1 or 3 comprises a fluid drainage system (5), wherein the fluid drainage system (5) is configured to be fluidically connected to the fluid outlet (20) of the detachable ambulatory suction module (4), and the fluid drainage system comprises a fluid collection container (6) and a negative pressure drainage mechanism.

12. The indwelling catheter system according to claim 11, wherein: The fluid drainage system includes a connector having a protruding conduit configured to protrude into the fluid outlet of the detachable walk-around suction module and open the actuatable closure.

13. The indwelling catheter system according to claim 6, wherein: The connection hub (10) and / or the outer housing (11) include at least one of: an antimicrobial coating or a UV light configured to direct light onto the catheter tube and / or the subject's skin at the incision.

14. The indwelling catheter system of claim 1, wherein: The skin anchor member comprises a base and a helical anchor for insertion into and under the skin by rotating the skin anchor member.

15. An indwelling pleural catheter system, comprising: an indwelling catheter device comprising a catheter tube having an open distal end configured to reside in a pleural or peritoneal cavity of a subject and a connecting hub fluidly coupled to a proximal end of the catheter tube; a skin anchoring member for anchoring the connection hub to the skin of the subject; as well as A detachable walk-around suction module configured for detachable attachment to the connection hub and comprising: a fluid inlet fluidly coupled to the catheter tube through the connection hub; a fluid outlet configured for detachable fluid coupling to a pleural fluid drainage system for draining pleural fluid through the detachable ambulatory suction module; and an actuatable closure member configured to close the fluid outlet when actuated, wherein the detachable ambulatory suction module is configured to apply negative pressure in the catheter tube upon actuation of the actuatable closure member; wherein the detachable ambulatory suction module comprises a negative pressure chamber, wherein the fluid inlet is fluidically coupled to the fluid outlet via the negative pressure chamber; and Wherein, the negative pressure chamber is configured to maintain negative pressure in the detachable ambulatory suction module when the detachable ambulatory suction module is disconnected from the pleural fluid drainage system and the actuatable closure is closed.

16. The indwelling pleural catheter system according to claim 15, wherein: The actuatable closure member (25) is configured to be closed by separating the pleural fluid drainage system from the detachable ambulatory suction module and to be opened when the pleural fluid drainage system and the detachable ambulatory suction module are attached.

17. The indwelling pleural catheter system according to claim 15, wherein: The connection hub (10) comprises a valve, which is configured to open when the connection hub is attached to the detachable ambulatory suction module (4) and to close when the connection hub is separated from the detachable ambulatory suction module.

18. The indwelling pleural catheter system according to claim 15, wherein: The skin anchor member (3) is separate from the connection hub (10), and the skin anchor member (3) is configured to be coupled to the connection hub (10).

19. The indwelling pleural catheter system according to claim 15, wherein: The skin anchoring member (3) comprises a through lumen (14) for receiving the catheter tube of the opening.

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