Indwelling Catheter System

Abstract

The indwelling pleural catheter system includes an indwelling catheter device (2) having a fenestrated distal end (7A) configured to reside in a subject's thoracic cavity and a connection hub (10) fluidly coupled to the proximal end (7B) of the catheter tube, a skin fixation member (3) for securing the connection hub (10) to the subject's skin, and an optional detachable, portable suction module (4) configured for removably mounting to the connection hub (10). The suction module (4) includes a fluid inlet (19) configured for fluid coupling to the catheter tube (7) through the connection hub (10) and a fluid outlet (20) configured for removably fluid coupling to a pleural fluid drainage system for draining pleural fluid through the detachable, portable suction module. The detachable, portable suction module is configured to apply negative pressure within the catheter tube upon disconnection of the pleural fluid drainage system from the suction module. Treatment of pleural effusion using the system of the present invention is described. An indwelling pleural catheter system for draining fluid from the peritoneal cavity and a method for 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 a pleural effusion in a subject utilizing an indwelling pleural catheter system. [Background technology]

[0002] Pleural effusion is a condition characterized by the accumulation of excess fluid in the pleural cavity, which is formed by lateral and visceral membranes that surround the lungs and function to facilitate breathing. Normally, the pleural cavity contains a small amount of fluid. Excess fluid can cause chest pain, coughing, difficulty breathing, and orthopnea. The 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 conditions.

[0003] Common treatments for pleural effusion include thoracentesis (removal of fluid using a syringe), chest tube insertion (removal of fluid using a chest tube that remains in situ for a number of days), pleural drainage (removal of fluid using a long-term indwelling catheter), and pleurodesis. The latter involves either chemical or mechanical irritation of the pleura and has a 70%-90% success rate in preventing the recurrence of the resulting pleural effusion. The treatments are extremely invasive, require lengthy hospital stays, and are contraindicated in patients with immobilized lungs.

[0004] Insertion of an indwelling pleural catheter (IPC) offers a less invasive, ambulatory alternative to pleurodesis procedures for managing pleural fluid. However, insertion of an IPC requires an invasive tunneling procedure, which involves the creation of two incisions to secure the catheter under the skin. Furthermore, current IPCs are designed only to drain pleural fluid and do not include a dedicated mechanism to prevent fluid from reaccumulating. As a result, many people treated with IPCs may only be effective with them for up to a year. Summary of the Invention [Problem to be solved by the invention]

[0005] An object of the present invention is to overcome at least one of the above mentioned problems. [Means for solving the problem]

[0006] Applicant addresses the problems of the prior art by providing an indwelling pleural catheter system that can perform drainage of pleural fluid and can also facilitate pleurodesis by extended application of negative pressure therapy to the pleural cavity after the drainage step. Application of negative pressure to the pleural cavity using an indwelling catheter serves to pull the lateral and visceral membranes together to facilitate pleurodesis. The catheter system comprises a fenestrated catheter tube having a connection hub at a proximal end and configured for placement within the pleural cavity, and a detachable suction module that is adjustable between three configurations and configured to attach to the connection hub. In the first configuration (drainage), the suction module provides a fluid connection between the connection hub and a pressurized drainage system, and pleural fluid is drained under pressure through the suction module. In the second configuration (negative pressure therapy), the drainage system is disconnected from the suction module, but the suction module remains under negative pressure, exerting negative pressure within the catheter tube and applying negative pressure therapy to the pleural cavity. The third configuration (rest) involves disconnection of the suction module from the connection hub, maintaining negative pressure within the catheter tube. In another aspect, the invention provides a catheter system for draining fluid from a body cavity in a subject, the body cavity being formed by a lateral membrane and a visceral membrane (eg, the thoracic or abdominal cavity).

[0007] In a first aspect, the present invention provides an indwelling pleural catheter system comprising: an indwelling catheter device comprising a catheter tube having a fenestrated distal end configured to reside within a subject's thoracic cavity and a connection hub fluidly coupled to a proximal end of the catheter tube; a skin fixation member for fixing the connection hub to the subject's skin; a fluid inlet configured to be removably attached to the connection hub and configured to be fluidly coupled to the catheter tube through the connection hub; a fluid outlet configured to be removably fluidly coupled to a pleural fluid drainage system for draining pleural fluid through the removable mobile suction module; and a removable mobile suction module comprising an exemplary actuable closure member configured to close the fluid outlet when actuated, the removable mobile suction module generally configured to apply a negative pressure within the catheter tube when the closure member is actuated.

[0008] Thus, the system of the present invention is configured in a first configuration to allow drainage of fluid from the thoracic cavity (e.g., a drainage system attached to the catheter via the ambulatory suction module with a closure member open) and in a second configuration to apply a predefined negative pressure therapy to the thoracic cavity via the suction module (e.g., the drainage system is disconnected from the suction module and a closure member within the suction module is closed to pressurize the suction module and apply negative pressure to the thoracic cavity through the catheter). A third, resting configuration involves disconnection of the ambulatory suction module from the connection hub.

[0009] In any embodiment, the removable mobile suction module includes a negative pressure chamber, and the fluid inlet is fluidly coupled to the fluid outlet by the negative pressure chamber. 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 negative pressure of the suction module and catheter tubing to enable negative pressure therapy of the thoracic cavity.

[0010] In any embodiment, the actuatable closure member is configured to close upon disconnection of the pleural fluid drainage system from the ambulatory suction module and to open upon attachment of the pleural fluid drainage system and the ambulatory suction module. 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 member. The closure member may be, for example, a duckbill valve or any other type of valve, such as a three-way valve or plate valve, or a combination of three-way valves or plate valves.

[0011] In any embodiment, the removable mobile suction module typically comprises an air bleed valve configured to maintain a threshold negative pressure in the catheter tube upon disconnection of the pleural fluid drainage system from the removable mobile suction module. The air bleed valve may be configured to open when the pressure in the suction module exceeds the threshold negative pressure and to allow air to enter the suction module once it closes until the threshold negative pressure is reached.

[0012] In any embodiment, the bleed valve is configured to maintain a limit negative pressure in the catheter tube of between 20 mmHg and 300 mmHg, between 20 mmHg and 200 mmHg, or between 20 mmHg and 140 mmHg.

[0013] In any embodiment, the system is configured to monitor pressure within the system, for example within the ambulatory suction module or within the catheter tube, and modify the negative pressure exerted by the fluid drainage system in response to the monitored pressure. Typically, the ambulatory suction module or catheter tube comprises a pressure sensor. Typically, the system comprises a processor operably coupled to the pressure sensor and the fluid drainage system (e.g., coupled to a pump of the fluid drainage system). Typically, the processor is configured to operate the fluid drainage system to compare the pressure sensed by the pressure sensor to a reference pressure and modify the negative pressure exerted by the fluid drainage system based on the comparison. In one embodiment, the system is configured to prevent the negative pressure within the system (e.g., within the ambulatory suction module or within the catheter tube) from falling below -140 mmHg (i.e., -141 mmHg, -142 mmHg, etc.). In one embodiment, the system is configured to maintain the negative pressure within the ambulatory suction module or within the catheter tube at a pressure between -20 mmHg and 300 mmHg, between -20 mmHg and 200 mmHg, or between -20 mmHg and 140 mmHg.

[0014] The connection hub is typically provided at the proximal end of the catheter tube and provides a hub for connection between the ambulatory suction module and the catheter tube. In any embodiment, the connection hub includes one or more closure members configured to open upon attachment of the removable suction module to the connection hub and to close upon decoupling of the connection hub and the removable suction module.

[0015] In any embodiment, the connection hub includes at least two spaced apart closure members, one of which may be a duckbill valve.

[0016] 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 connection hub to open the closure member or members.

[0017] In any embodiment, the skin fixation member is separate from the connection hub and configured for coupling with the connection hub. This allows the skin fixation member to be attached to the skin prior to attachment to the connection hub. The coupling may be a snap-fit ​​coupling, a friction-fit coupling, a threaded coupling, or any other type of coupling.

[0018] In another embodiment, the skin fixation member may be integrally formed with the connection hub and may optionally be configured to rotate relative to the connection hub.

[0019] In any embodiment, the skin fixation member includes a through lumen for receiving the fenestrated catheter tube.

[0020] In any embodiment, the system includes an outer housing, which is a housing that surrounds the connection hub and is configured for attachment (typically releasable attachment) to the connection hub, with a through lumen for receiving the connection hub to expose a proximal end of the connection hub, and a base configured to abut and preferably attach to the skin of a subject around the connection hub, providing a seal around the connection hub and protecting the connection hub, fixation member and incision from contact with fluids or dirt during use of the system.

[0021] In any embodiment, the base of the cover comprises an adhesive element for attaching the base of the cover to the subject's skin around the connection hub. The cover may include a peel-off backing.

[0022] In any embodiment, the outer housing and the removable suction module may be sized to facilitate mating. For example, the removable suction module may have a recessed base and the outer housing may be sized to nest within the recessed base of the removable suction module. The recessed base of the removable suction module may be concave and the outer housing may be convex.

[0023] In any embodiment, a portion of the fluid inlet of the removable suction module protrudes and fills the function of a recessed base of the removable suction module, which allows the fluid inlet to protrude into the connection hub and establish fluid communication with the catheter through the connection hub.

[0024] In any embodiment, the indwelling pleural catheter system is configured to be assembled into several different configurations, including a rest configuration in which the removable suction module is not fluidly connected to the connection hub, a drainage configuration in which the removable suction module is fluidly connected to the connection hub and the pleural fluid drainage system enables drainage of pleural fluid under pressure through the catheter device and the removable mobile suction module, and a negative pressure therapy configuration in which the removable suction module is fluidly coupled to the connection hub, not fluidly coupled to the pleural fluid drainage system, and negative pressure is applied.

[0025] In any embodiment, the removable suction module and the outer housing are configured to couple together. The coupling can be a snap-fit ​​coupling, a friction-fit coupling, a threaded coupling, or any other type of coupling.

[0026] In any embodiment, the system includes a pleural fluid drainage system configured to fluidly couple to the outlet of the removable suction module. The pleural fluid drainage system generally includes a pleural fluid collection container and a pump configured to drain pleural fluid from the pleural cavity into the collection container. The drainage system in some embodiments may not have a pump and may be configured to drain pleural fluid from the pleural cavity by other means, including gravity.

[0027] In any embodiment, the system comprises a needle, a cannula and a peel-away catheter / dilator.

[0028] In any embodiment, the connection hub and / or the cover comprises a UV light configured to direct light onto the catheter tube and / or the skin. Typically, the cover comprises a UV light configured to direct light onto the catheter tube and / or the skin.

[0029] In any embodiment, the connection hub and / or the cover include an antimicrobial coating.

[0030] In any embodiment, the connection hub and the skin fastening member are configured to couple together, which may be a snap-fit ​​coupling, a friction-fit coupling, a threaded coupling, or any other type of coupling.

[0031] In a second aspect, the present invention provides an indwelling catheter system for draining fluid from a body cavity of a subject formed by lateral and visceral membranes (e.g. the thoracic or abdominal cavity), the system comprising an indwelling catheter device comprising a catheter tube with a fenestrated distal end configured to reside within the body cavity of the subject, and a connection hub disposed at the proximal end of the catheter tube and configured to fluidly couple the fluid drainage device and the catheter tube, and a skin fixation member having a through lumen for receiving the catheter tube, a fixation element configured to fix to the skin of the subject, and a coupling element configured to couple the skin fixation member to the connection hub.

[0032] In any embodiment, the system includes an outer housing that is a housing configured for attachment (typically removably attachment) to the connection hub, has a through lumen for receiving the connection hub to expose a proximal end of the connection hub, and a base configured to abut against the subject's skin around the connection hub and optionally attach to the skin, and surrounds the connection hub.

[0033] In any embodiment, the base of the cover comprises an adhesive element for attaching the cover to the subject's skin around the connection hub. The base may include a backing member for the adhesive element.

[0034] In another aspect, the invention provides an ambulatory suction module suitable for use with an indwelling pleural or peritoneal catheter, the module comprising a housing having a fluid inlet configured for releasable fluid coupling to a connection hub of an indwelling pleural catheter, a fluid outlet configured for releasable fluid coupling to a pleural fluid drainage system, and an actuatable closure member configured to close the fluid outlet upon actuation, the detachable ambulatory suction module typically configured to apply negative pressure in the catheter tube upon actuation of the closure member.

[0035] In any embodiment, the removable mobile suction module comprises a negative pressure chamber, and the fluid inlet is fluidly coupled to the fluid outlet by the negative pressure chamber. Typically, the negative pressure chamber has a volume of at least 10cc, 15cc, 20cc, 25cc, or 30cc.

[0036] In any embodiment, the actuatable closure member is configured to close upon disconnection of the pleural fluid drainage system from the removable mobile suction module and to open upon attachment of the pleural fluid drainage system and the removable mobile suction module. The drainage system may include a connector with a protruding conduit that protrudes into the fluid inlet of the suction module and is configured to open the closure member. The closure member may be, for example, a duckbill valve or any other type of valve, such as a three-way valve or plate valve, or a combination of three-way valves or plate valves.

[0037] In any embodiment, the removable mobile suction module includes a bleed valve configured to maintain a threshold negative pressure in the catheter tube upon disconnection of the pleural fluid drainage system from the removable mobile suction module, the bleed valve opening when pressure in the suction module exceeds the threshold negative pressure.

[0038] In any embodiment, the bleed valve is configured to maintain a limit negative pressure in the catheter tube of between 20 mmHg and 300 mmHg, between 20 mmHg and 200 mmHg, or between 20 mm and 140 mm.

[0039] In any embodiment, the system includes a pressure sensor to determine the negative pressure in the system, which may be located in the ambulatory suction module or in the catheter tubing (or any other part of the system, such as a fluid conduit connecting the drainage system with the ambulatory suction module).

[0040] 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.

[0041] 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 by forming or promoting the formation of a pleurodesis.

[0042] In another aspect, the invention provides a method of treating pleural effusion in a subject utilizing an indwelling pleural catheter having a fenestrated distal end, the method comprising the steps of: creating an incision in the subject's chest at an incision point; inserting the indwelling pleural catheter into the subject's chest through the incision until the fenestrated distal end of the catheter tube is disposed within the thoracic cavity and the proximal end of the catheter is disposed on a surface of the subject's chest; and a 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, the method comprising negative pressure therapy comprising applying a second negative pressure to the pleural cavity through the pleural catheter after the drainage step.

[0043] In any embodiment, the second negative pressure is less than or equal to the first negative pressure. In any embodiment, the second negative pressure applied to the catheter tube is between 20 mmHg and 300 mmHg, between 20 mmHg and 200 mmHg, or between 20 mmHg and 140 mmHg.

[0044] In any embodiment, the method includes maintaining the negative pressure within the thoracic cavity during the transition from the first negative pressure to the second negative pressure.

[0045] In any embodiment, the method includes the step of anchoring the proximal end of the catheter to the skin at the incision.

[0046] In any embodiment, the method includes a pause step during which neither the first negative pressure nor the second negative pressure is applied to the pleural catheter.

[0047] In any embodiment, the method includes fluidly coupling a removable suction module to a proximal end of the indwelling pleural catheter, the removable suction module configured to removably fluidly attach to a pleural fluid drainage system configured to apply a first negative pressure to the pleural catheter, and the draining step includes fluidly attaching the removable suction module to the pleural fluid drainage system.

[0048] In any embodiment, the removable suction module is configured to apply a second negative pressure to the pleural catheter when it is fluidly disconnected from the pleural fluid drainage system, and the negative pressure therapy step includes a step of fluidly disconnecting the pleural fluid drainage system from the removable suction module.

[0049] In any embodiment, the pausing step includes disconnecting the detachable suction module from the pleural catheter.

[0050] In another aspect, the present invention provides a method of treating pleural effusion in a subject utilizing an indwelling pleural catheter system according to the present invention, the method comprising the steps of: creating an incision in the subject's chest at an incision point; inserting a catheter tube of an indwelling catheter device into the subject's chest through the incision until a fenestrated distal end of the catheter tube is disposed within the thoracic cavity and a connection hub is disposed on a surface of the chest at the incision point; securing the connection hub to the subject's skin with a skin securement member; draining pleural fluid from the thoracic cavity under negative pressure by coupling the connection hub and a detachable mobile suction module to a pleural fluid drainage system and activating the pleural fluid drainage system; and applying negative pressure therapy to the thoracic cavity through the catheter tube by applying negative pressure exerted by the detachable mobile suction module to the pleural fluid drainage system.

[0051] In any embodiment, the method includes coupling the outer housing to the connection hub prior to coupling the connection hub to the detachable mobile suction module.

[0052] In any embodiment, the method includes a pausing step that includes decoupling the detachable mobile suction module from the connection hub to maintain negative pressure within the catheter tube.

[0053] In any embodiment, the method includes a step in which a catheter tube is inserted through a single cavity in the chest.

[0054] In any embodiment, the skin fixation member is separate from the connection hub and configured to couple to the connection hub, and the method includes securing the skin fixation member to the subject's skin at the incision site, inserting the catheter tube into the subject's chest, and coupling the connection hub to the secured skin fixation member.

[0055] In any embodiment, the skin fixation member includes a central opening for receiving the catheter tube, and the method includes the step of fixing the skin fixation member to the skin such that the central opening of the skin fixation member overlies an incision site on the subject's chest, whereby the step of inserting the catheter tube into the subject's chest is performed through the central opening of the skin fixation member.

[0056] 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.

[0057] In any embodiment, the negative pressure therapy step lasts 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.

[0058] In any embodiment, the steps of inserting the catheter tube into the thoracic cavity and securing the connection hub include securing a skin fixation member at the incision point, inserting a needle and introducer through the incision and through the chest wall into the thoracic cavity, removing the needle and leaving the introducer in place, advancing a guidewire over the introducer and into the thoracic cavity, removing the introducer over the guidewire and leaving the guidewire in place, advancing a peel-away catheter / dilator over the guidewire into the thoracic cavity, removing the dilator portion of the catheter / dilator and the guidewire, advancing the catheter tube through the peel-away catheter until the connection hub abuts the peel-away catheter, removing the peel-away catheter, and coupling the connection hub to the skin fixation member.

[0059] In another aspect, the present invention provides a method of treating pleural effusion in a subject comprising applying negative pressure therapy to the subject's pleural cavity via an indwelling pleural catheter for a period of time to facilitate pleurodesis.

[0060] Generally, the method includes a step of draining pleural fluid from the pleural cavity for a period of time prior to the negative pressure therapy step.

[0061] In one embodiment, the negative pressure therapy step includes applying a negative pressure of 20 mmHg to 300 mmHg, 20 mmHg to 200 mmHg, or 20 mmHg to 140 mmHg to the subject's thoracic cavity via an indwelling pleural catheter.

[0062] In one embodiment, the negative pressure therapy step lasts 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.

[0063] In one embodiment, the method includes multiple negative pressure treatments and, optionally, multiple drainage treatments.

[0064] In another aspect, the invention provides a method of treating a condition associated with accumulation of fluid within a body cavity of a subject formed by lateral and visceral membranes, e.g., ascites or pleural effusion, utilizing the system of the invention, the method comprising the steps of creating an incision in the abdomen or chest of the subject at an incision point, inserting a catheter tube of an indwelling catheter device through the incision into the abdomen or chest of the subject until a fenestrated distal end of the catheter tube is disposed within the body cavity and a connection hub is disposed on the surface of the skin at the incision point, securing the connection hub to the skin of the subject with a skin securing member, and draining fluid from the body cavity under negative pressure by coupling the connection hub to a fluid drainage system and activating the fluid drainage system.

[0065] Further aspects and preferred embodiments of the present invention are defined and described in the other claims set forth below. [Brief description of the drawings]

[0066] [Figure 1]FIG. 1 is a diagram of an indwelling pleural catheter according to the present invention showing the indwelling catheter device (catheter tube and connection hub), skin fixation member, a cover for the connection hub, a removable movable suction module, and a pleural fluid drainage module. [Diagram 2] FIG. 2 is a perspective view of a skin fixation member forming part of the system of FIG. 1. [Diagram 3] FIG. 2 is a plan view of an indwelling catheter device forming part of the system of FIG. 1, comprising a catheter tube having a fenestrated distal end adapted to reside within a subject's thoracic cavity and a connection hub. [Figure 4] 2 is a perspective view of a removable outer housing for a connection hub forming part of the system of FIG. 1. FIG. [Diagram 5] FIG. 2 is a perspective view from below of an ambulatory suction module forming part of the system of FIG. 1. [Figure 6] FIG. 13 is a diagram of a connector for connecting a pleural fluid drainage system to the ambulatory suction module. [Figure 7] 1 is a diagram of the ambulatory suction module about to be coupled and fluidly connected to the connection hub and outer housing. [Figure 8] FIG. 8 is a cross-sectional view of the ambulatory suction module of FIG. [Figure 9] 8 is a cross-sectional view of the connection hub, catheter, and outer housing of FIG. 7. [Figure 10A] FIG. 1 illustrates the use of the system of the present invention to treat pleural effusion, showing a patient with an indwelling pleural catheter device inserted into the thoracic cavity with a distal catheter tube (not shown), a connection hub secured to the patient's skin (not shown), an outer housing coupled to the connection hub (not shown), and an ambulatory suction module and pleural fluid drainage system on a table and fluidly connected. [Figure 10B] 13A-13C illustrate the use of the system of the present invention to treat pleural effusion, showing the sanitary cap being removed from the outer housing by the patient. [Figure 10C] FIG. 13 illustrates the use of the system of the present invention to treat pleural effusion, showing the suction module being coupled to the connection hub by the patient. [Figure 10D] FIG. 13 illustrates the use of the system of the present invention to treat pleural effusion, showing the patient activating the drainage pump to drain fluid from the pleural cavity through the pleural catheter and ambulatory suction module. [Figure 10E] 1A-1C illustrate the use of the system of the present invention to treat pleural effusion, showing the drainage step with the patient in a sitting position while the drainage step is performed. [Figure 10F] FIG. 13 illustrates the use of the system of the present invention to treat pleural effusion, showing the connector of the pleural fluid drainage system being disconnected from the ambulatory suction module to end the drainage step and begin the negative pressure therapy step. [Figure 10G] 1 illustrates the use of the system of the present invention to treat pleural effusion, showing a negative pressure therapy step during which the ambulatory suction module remains fluidly connected to the connection hub to apply negative pressure to the pleural cavity to facilitate pleurodesis, during which the patient may be ambulatory as illustrated. [Figure 10H] 14 illustrates the use of the system of the present invention to treat pleural effusion, showing the patient disconnecting the ambulatory suction module from the connection hub to end the negative pressure therapy step and begin the pause step, when a valve in the connection hub closes to fluidly seal the indwelling pleural catheter. [Figure 10I] FIG. 1 illustrates the use of the system of the present invention to treat pleural effusion, showing a patient with the connection hub and outer housing exposed and the sanitary cap on the table. [Figure 10J] FIG. 13 illustrates the use of the system of the present invention to treat pleural effusion, showing the patient about to apply the sanitary cap to the outer surface of the connection hub and the outer housing. [Figure 10K] 1 illustrates the use of the system of the present invention to treat pleural effusion, showing the patient during a rest step in which the sanitary cap covers the outer surface of the connection hub and the outer housing, and is shown seated, although the patient may be ambulatory during this step. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0067] All publications, patents, patent applications, and other references mentioned in this specification 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 by its contents as fully recited.

[0068] Definitions and Overall Preferences As used herein, and unless specifically stated otherwise, the following terms are intended to have the following meanings, in addition to any broader (or narrower) meaning that such terms may enjoy in the art.

[0069] Unless the context specifically indicates otherwise, the use of the singular herein should be read to include the plural and vice versa. The term "a" or "an" used in connection with an entity should be read 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.

[0070] As used herein, the term "comprise" or variations thereof, "comprises" or "comprising" should be read to indicate the inclusion of any recited integer (e.g., feature, element, feature, property, method / process step, or limitation) or group of integers (e.g., feature, element, feature, property, method / process step, or limitation) but not the exclusion of any other integer or group of integers. Thus, as used herein, the term "comprising" is inclusive or open-ended and does not exclude additional unrecited integers or method / process steps.

[0071] As used herein, the term "disease" is used to define any abnormal condition that impairs physiological function and is associated with characteristic symptoms. The term is used broadly to encompass any ailment, ill-health, disorder, disease, discomfort, condition or syndrome in which physiological function is impaired, regardless of the nature of the etiology (or, of course, whether or not an etiological basis for the disease has been established). It thus encompasses symptoms resulting from infection, trauma, injury, surgery, ablation with radiation, age, poisoning or malnutrition.

[0072] As used herein, the term "treatment" or "treating" refers to an intervention (e.g., administration of a drug to a subject) that cures, ameliorates, or alleviates the symptoms of a disease, or removes (or reduces the effects of) its cause (e.g., reducing the accumulation of pathological levels of lysosomal enzymes), in which case the term is used synonymously with the term "therapy."

[0073] Additionally, the term "treatment" or "treating" refers to an intervention (e.g., administration of a drug to a subject) that prevents or slows the onset or progression of a disease, or reduces (or eradicates) its frequency of occurrence in a treated population. In this case, the term treatment is used synonymously with the term "prevention." Treatment results in this context include eradication or reduction of symptoms, relief of pain or discomfort, prolonged survival, improved mobility, and other indicators of clinical improvement. Treatment results do not have to be a complete cure. Improvements may also 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 species of animals (horses, camels, dogs) and domestic pets (cats and dogs).

[0074] In the context of treatment and effective amounts as defined above, the term subject (which should be read to include "individual", "animal", "patient" or "mammal" where the context permits) defines any subject, particularly a mammalian subject for whom treatment is indicated. Mammalian subjects include, but are not limited to, humans, livestock, farm animals, zoo animals, sport animals, such as pet animals, such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, camels, pythons, cows, cows, primates, such as apes, monkeys, orangutans and chimpanzees, canines, such as dogs and wolves, felines, such as cats, lions and tigers, equines, such as horses, donkeys, zebras, food animals, such as cows, 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 the group of mammals in the family Horseidae, which includes horses, donkeys, African donkeys, Tibetan donkeys and zebras.

[0075] "Pleural effusion" refers to a condition characterized by the accumulation of excess fluid in the pleural cavity, which is formed by lateral and visceral membranes that surround the lungs and function to facilitate breathing. Normally, the pleural cavity contains a small amount of fluid. Excess fluid can cause chest pain, coughing, difficulty breathing, and orthopnea. The 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 conditions.

[0076] An "indwelling catheter device" refers to a catheter suitable for treating a condition characterized by accumulation of fluid within a body cavity, such as the thoracic or abdominal cavity, e.g., pleural effusion or ascites, having a length of catheter tubing with a fenestrated distal end and a connector, such as a connection hub, fluidly connected to the catheter tubing at a proximal end. In an indwelling catheter device, the catheter tubing is sized to pass through the chest wall and fit within and along the thoracic cavity. The fenestrations (openings) in the catheter tubing are generally sized to allow drainage of fluid from the thoracic cavity through the tubing under pressure.

[0077] "Connection hub" refers to a proximal portion of a catheter device that is fluidly coupled to a detachable ambulatory suction module (or in some embodiments, a fluid drainage device) and is generally configured to secure the catheter device to a patient's skin by attachment to a separate fixation member that is itself attached to the patient's skin (although in one embodiment, the fixation member may form part of the connection hub). The connection hub comprises a closure member or members (e.g., one or more valves) that are configured to close when the ambulatory suction module is separated from the connection hub and that maintain a vacuum on the catheter tube. The connection hub is configured to engage with the suction module or cover in some manner, for example, by a snap fit, friction fit, or rotational lock engagement mechanism. In one embodiment, the connection hub comprises a base element and a through lumen. The base may comprise a configuration to allow the connection hub to be coupled to the fixation member.

[0078] "Skin fixation member" refers to a device configured to fix to the skin and in one embodiment to couple with a connection hub. In one embodiment, it comprises a base and a helical fastener for insertion into and under the skin by rotation of the fixation member. In general, the base comprises a through opening through which the catheter tube is advanced into the thoracic cavity. The base may comprise a configuration for coupling with the connection hub. In one embodiment, the skin fixation member comprises an upper medical article attachment portion and a lower insertion portion for subcutaneously stabilizing the fixation member to the subject, the insertion portion comprising a helical fastener arranged substantially in a single plane. In one embodiment, the helical fastener is formed in an Archimedes spiral, e.g., the helical fastener is arranged in a single plane. Preferably, the helical fastener extends laterally outward from the medical article attachment portion. In one embodiment, the helical fastener comprises at least one full turn. Preferably, the helical fastener is flexible. Preferably, the helical fastener comprises a free insertion end for insertion into the subject. In one embodiment, the medical fastening device further comprises a gap for receiving the skin between the medical article mounting portion and the helical fastener. Preferably, the gap comprises a slot-shaped gap. Preferably, the gap is formed by a spacer arm between the medical article mounting portion and the helical fastener. More preferably, the spacer arm is configured to form a curved skin-contacting surface. In one embodiment, the curved skin-contacting surface comprises a concave skin-contacting surface. Preferably, the spacer arm comprises a non-flexible spacer arm. Preferably, the helical fastener is mounted to the medical article mounting portion at the medical article mounting portion end and is in contact with the medical article mounting portion. In one embodiment, the medical article mounting 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 generally circular, elliptical, square, rectangular or any other shape. In one embodiment, the medical article mounting portion comprises an adhesive for adhering the mounting portion to the subject around the incision. More preferably, the lumen comprises a top opening and a bottom opening. Advantageously, the platform includes a medical item mounting platform.Preferably, the medical supply mount comprises a top medical supply mount at the top opening. Optionally, or additionally, the medical supply mount comprises a bottom medical supply mount at the bottom opening. In one embodiment, the top medical supply mount and / or the bottom medical supply mount comprise threads. Other forms of mounting may be utilized, such as, for example, re-entrant slots, friction fit mountings, adhesive mountings, and clips or clamps.

[0079] "Outer housing" (or "pleural port") refers to a housing configured to mate with a connection hub and have a through lumen for receiving the connection hub such that a top surface of the connection hub is exposed at the top of the outer housing, thereby making the fluid inlet of the suction module accessible. The outer housing may be sized to match the ambulatory suction module.

[0080] A "detachable mobile suction module" refers to a device that removably mounts to a connection hub (optionally via an outer housing) and has an inlet for fluid connection with the connection hub, an outlet for connection to a pleural fluid drainage system, and a fluid conduit fluidly connecting the inlet and the outlet, which generally includes a negative pressure chamber configured to maintain a negative pressure within the module when the module is isolated from the fluid drainage system and sealed with a closure member such as a valve. The negative pressure chamber generally has a volume of at least 20cc to 30cc. The module is configured to exert a negative pressure within the catheter device when it is isolated from the pleural fluid drainage system. The suction module also includes a means for controlling the negative pressure applied by the suction module when it is isolated from the pleural fluid drainage system, which in one embodiment is a valve such as a bleed valve configured to dissipate the negative pressure within the suction module (e.g., allow air to enter the suction module until a target (limit) negative pressure is obtained). In one embodiment, the means (e.g., bleed valve) is adjustable to change the target pressure according to the required negative pressure therapy.

[0081] "Pleural fluid drainage system" refers to a system configured for attachment to a detachable suction module and for extraction of pleural fluid under pressure through an indwelling catheter device and a suction module when they are connected. The system of the present invention may include a pleural fluid drainage system. The system generally comprises a pump or other means (e.g., a gravity-fed drainage system or a negative pressure system) for draining fluid from a body cavity through an indwelling catheter tube, a fluid collection container and associated tubing. In one embodiment, the pleural fluid drainage system is configured to perform pleural fluid drainage at a negative pressure (e.g., -120 mmHg) greater than the target negative pressure (e.g., -90 mmHg) employed in negative pressure therapy. The pleural fluid drainage system includes a conduit that fluidly connects with the ambulatory suction module via a connector element. In one embodiment, the connector element comprises a protruding fluid conduit configured to protrude into and establish a fluid connection with the ambulatory suction module's fluid outlet. In one embodiment, the fluid outlet comprises a closure member (eg, a duckbill valve, a three-way valve, or a plate valve, or a combination thereof) configured to be opened by a protruding fluid conduit of the connector element.

[0082] "Ambulatory" as applied to a detachable suction module means that the device can be worn by the patient while allowing the patient to be ambulatory; in other words, the suction module is wearable and does not require the patient to be stationary, sitting, or lying in bed for use.

[0083] By "target negative pressure" is meant a negative pressure sufficient to facilitate pleurodesis in the pleural cavity of a patient suffering from pleural effusion, while being safe and comfortable for the patient. It is understood that the target negative pressure will vary from patient to patient depending on the patient's clinical situation, age and health status, but it is generally within the range of 20mmHg to 300mmHg, 20mmHg to 200mmHg, or 20mmHg to 140mmHg. In one embodiment, the target negative pressure in the catheter tube is 20mmHg to 40mmHg, 20mmHg to 60mmHg, 20mmHg to 80mmHg, 20mmHg to 100mmHg, 20mmHg to 140mmHg, 20mmHg to 200mmHg, 20mmHg to 300mmHg, 40mmHg to 60mmHg, 40mmHg to 80mmHg, 40mmHg to 80mmHg, 40mmHg to 90mmHg, 40mmHg to 100mmHg, 40mmHg to 140mmHg, 40mmHg to 200mmHg, 40mmHg to 300mmHg, 40mmHg to 60mmHg, 40mmHg to 8 ... 0mmHg~100mmHg, 60mmHg~80mmHg, 60mmHg~100mmHg, 60mmHg~120mmHg, 80mmHg~100mmHg, 80mmHg~120mmHg, 80mmHg~140mmHg, 100mmHg~120mmHg, 100mmHg~140mmHg, 120mmHg~140mmHg.

[0084] Example The present invention will now be described with reference to specific examples, which are merely exemplary and for illustrative purposes only, and which are not intended to limit in any manner the scope of the claimed proprietary rights or the invention described. These examples constitute the best modes currently contemplated for carrying out the invention.

[0085] System Components 1, an indwelling catheter system according to one embodiment of the present invention is illustrated in an exploded view. The system is generally designated by reference numeral 1 and includes an indwelling catheter device 2 with a proximal connection hub 10, a fixation member 3 (shown prior to coupling with the connection hub), a detachable ambulatory suction module 4, and an outer 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 for providing a fluid connection between the container 6 and the ambulatory suction module 4 for pressurized drainage of pleural fluid from the thoracic cavity through the catheter device and the suction module to the container 6.

[0086] 2-9, the components of this embodiment of the system of the present invention are described in more detail.

[0087] 2, the fixation member 3 is a helical fastener having a base 12 and a helical member 13 formed from a suitable elastomer, such as Santoprene, with a leading edge for insertion into an incision in the skin whereby rotation of the fixation member embeds the helical member into the skin. The base 12 has a through lumen 14 for receiving the catheter device 2 and an annular shoulder 28 within the through lumen for mating with the connection hub 10.

[0088] 3, the indwelling catheter device 2 comprises a silicone catheter tube 7 having a distal end 7A with a plurality of fenestrations 8 and a proximal end 7B that terminates in a connection hub 10. The base 9 of the connection hub 10 includes an annular shoulder for a turn-lock or push-lock connection with the through lumen 14 of the fixation member 3. The connection hub also includes two spaced apart valves as described in detail below.

[0089] 4, the outer housing 11 comprises a dome-shaped housing having a through lumen 15 sized to receive the connection hub 10 such that the proximal end 10A of the connection hub 10 sits generally flush with the upper surface of the outer housing when the outer housing and the connection hub are coupled, and an annular base element 21 configured to abut the skin around the fixation members 3. The base element 21 comprises an adhesive element (not shown) for stabilizing the base element against the subject's skin around the fixation members 3. The purpose of the cover is two-fold, to protect the connection hub and incision and to provide a top surface that facilitates mating of the ambulatory suction module 4 and the connection hub 10.

[0090] 5, 7 and 8, the removable mobile suction module 4 comprises a housing 16 having a flat top 17 and a concave underside 18 sized to match the convex top of the outer housing 11 of the connection hub 10. The housing 16 defines a fluid channel through the module from a protruding fluid inlet 19 protruding from the concave underside 18 to a fluid outlet 20 located at the periphery of the module. The fluid channel includes a negative pressure chamber 24 having a volume of about 30 cc. The fluid outlet 20 comprises a closure member in the form of a clip 25 configured to close the fluid outlet 20 when the fluid connector 26 of the pleural fluid drainage system 5 is separated from the fluid outlet 20 to close the outlet and fluidly seal the module. A three-way valve or a plate valve (or a combination of a three-way valve and a plate valve) may be utilized as the closure member. The sealing of the fluid outlet 20 in combination with the pressure in the negative pressure chamber 24 results in a negative pressure being applied to the module, exerting a negative pressure through the catheter device 2 to the thoracic cavity. The module 4 also includes a bleed valve 22 configured to maintain a limit negative pressure within the module, which in this embodiment is a negative pressure of 90 mmHg. Additionally or alternatively, the ambulatory suction module 4 or the catheter tube may include a pressure sensor. The pressure sensor may be operably coupled to the fluid drainage system 5 (e.g., to a pump of the drainage system) to modify the negative pressure exerted by the fluid drainage system based on pressure readings obtained by the pressure sensor. The sensor and drainage system may be operably coupled to a processor, such that the processor is configured to receive pressure readings from the pressure sensor, compare the pressure readings to a reference pressure, and modify the negative pressure exerted by the fluid drainage system based on the comparison. In one embodiment, the system is configured to prevent negative pressure within the system, and in particular the negative pressure within the ambulatory suction module, from falling below -40 mmHg (i.e., -141 mmHg, -142 mmHg, etc.). In one embodiment, the system is configured to maintain a negative pressure in the ambulatory suction module or catheter tube at a pressure between 20 mmHg and 300 mmHg, between 20 mmHg and 200 mmHg, or between 20 mmHg and 140 mmHg.

[0091] 6-8, the fluid connector 26 of the pleural fluid drainage system has a protruding conduit 29 that protrudes into the fluid outlet 20 when the connector 26 is coupled to the ambulatory suction module 4, forcing the clip 25 open to open the fluid outlet of the suction module 4 and allowing fluid to be drained from the thoracic cavity through the catheter device and the suction module 4.

[0092] 9 shows the connection hub 10, the fixation member 3 coupled to the connection hub, and the outer housing 11 coupled to the connection hub with the proximal end 10A of the connection hub exposed. The connection hub 10 includes a through conduit having two spaced apart valves, a three-way valve 30 and a duckbill valve 31. These valves are biased to a closed position to fluidly seal the connection hub, preventing the passage of fluid into the catheter tube and preventing the passage of undesired fluids out of the thoracic cavity.

[0093] 8 and 9, the connection hub 10 and ambulatory suction module 4 are illustrated prior to coupling, with the suction module 4 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, pushing valves 30 and 31 open and establishing fluid communication between the ambulatory suction module and the thoracic catheter. Similarly, when the suction module 4 and connection hub 10 are separated, the valves close, fluidly sealing the connection hub and preventing air and fluid from passing into the catheter tube.

[0094] How to treat pleural effusion The use of the system of the present invention is illustrated with reference to Figures 10A-10K.

[0095] Referring first to Figure 10A, the patient is illustrated with the indwelling catheter and fixation member next in place, with the connection hub and cover placed on the patient's chest surface and covered by the sanitary cap 32. At this stage, the valves 30, 31 in the connection hub are closed. The suction module 4 and drainage system 5 are shown on the table behind the patient in a fluidly connected configuration. The drainage system includes a pump (not shown) in line in the conduit 23, and a controller 33. Figure 10B shows the sanitary cap 32 being removed from the outer housing by the patient.

[0096] Figure 10C shows the suction module 4 being coupled to the connection hub by the patient. 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, establishing fluid communication between the pleural catheter and the suction module 4. At this stage, the pump of the drainage system is not activated.

[0097] FIG. 10D shows the patient actuating the pump of the drainage system via controller 33 to initiate the drainage step, starting the drainage of fluid from the thoracic cavity, through the pleural catheter and suction module 4, and into container 6.

[0098] FIG. 10E illustrates the drain step with the patient in a sitting position while the drain step is performed.

[0099] As illustrated in Fig. 10F, when the drainage step is completed, the patient disconnects the connector 26 of the pleural fluid drainage system from the ambulatory suction module 4 to end the drainage step and begin the negative pressure therapy step. Upon disconnection of the connector 26 from the outlet of the suction module 4, a valve at the fluid outlet of the suction module closes while maintaining negative pressure in the suction module by a negative pressure chamber in the suction module. The negative pressure is controlled by an air bleed valve in the suction module that is designed to dissipate negative pressure by allowing air to enter the suction module if the pressure is too low to maintain the negative pressure at a threshold negative pressure for the duration of the negative pressure therapy step.

[0100] 10G illustrates a negative pressure therapy step in which the ambulatory suction module remains fluidly connected to the connection hub to apply negative pressure to the thoracic cavity to facilitate pleurodesis, during which the patient may be ambulatory as illustrated.

[0101] 10H illustrates the patient disconnecting the ambulatory suction module 4 from the connection hub 10 to end the negative pressure therapy step and begin the pause step. Upon disconnection, a valve in the connection hub closes to fluidly seal off the indwelling pleural catheter.

[0102] Figure 10I shows the patient with the connection hub 10 and outer housing 11 exposed and the sanitary cap 32 resting on the table, Figure 10J shows the patient about to apply the sanitary cap to the outer surface of the connection hub and outer housing, and Figure 10K shows the patient during a rest step with the sanitary cap 32 covering the outer surface of the connection hub and outer housing. The patient is shown seated, but the patient may be ambulatory during this step.

[0103] Placement of an indwelling pleural catheter 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 the side of the chest, and the leading edge of the helical fastener is inserted into the incision where it is rotated to embed the fastener under the skin.

[0104] The introducer and needle / syringe are then inserted through the opening in the helical fastener and through the intercostal muscles into the thoracic cavity. Imaging, such as ultrasound, may be used to guide safe advancement of the catheter into the thoracic cavity. The needle / syringe is removed, leaving the introducer in situ. A guidewire is then advanced through the introducer into the thoracic cavity, and the needle / syringe is then removed.

[0105] A peel-away catheter / dilator is then advanced over the guidewire into the pleural cavity. After removal of the dilator and guidewire, the surgeon's thumb is placed over the exit port at the end of the peel-away catheter to prevent drainage of pleural fluid.

[0106] The distal end of the catheter device is then advanced through the peel-away catheter until the connection hub abuts the peel-away catheter, whereupon the peel-away catheter is removed and the connection hub is coupled to the helical fastener.

[0107] An outer housing with a through lumen (pleural port) 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 secured against the subject's skin around the fixation member.

[0108] Summary The embodiments described above utilize an outer housing 11 that surrounds the connection hub and covers the incision site, which also covers the connection hub with a cover configured to mate with the suction module 4. It should be understood that a cover is not required in some embodiments, and that the connection hub may be sized to provide a surface that covers the incision site and promotes mating with the suction module. Similarly, in the embodiments described above, the securing member 3 and the connection hub 10 are separate elements that are configured to mate together once the securing member is secured to the patient's skin. It should be understood that in certain embodiments, the securing member may form part of the connection hub, or may be configured to rotate fixedly relative to the connection hub.

[0109] Equivalent The above description details the presently preferred embodiments of the present invention. It is expected that many modifications and variations in the practice of the present invention will occur to those skilled in the art upon reading these descriptions. Such modifications and variations are intended to be encompassed within the scope of the claims appended hereto. [Explanation of symbols]

[0110] 1 Catheter system 2. Catheter Device 3 Skin fixation member 4 Suction Module 5. Drainage System 6 Collection Containers 7 Catheter Tube 7A Distal end of catheter tube 7B Proximal end of catheter tube 8 Fenestration 9. Base 10 Connection Hub 10A Connection Hub Proximal End 11 Outer housing 12 Base 13 Spiral clasp 14 Lumen 15 Through lumen 16 Housing 17 Top 18 Concave underside 19 Fluid inlet 20 Fluid outlet 21 Base Elements 22 Bleed valve 23 Conduit 24 Negative Pressure Chamber 25 Closing member 26 Fluid Connector 29 Projecting conduit 30 Valves 31 Valve 32 Hygienic Cap 33 Control device

Claims

1. 1. An indwelling catheter system for draining fluid from a body cavity of a subject formed by a lateral membrane and a visceral membrane, comprising: an indwelling catheter device (2) comprising a catheter tube (7) having a fenestrated distal end (7A) configured to reside in the body cavity of the subject, and a connection hub (10) disposed at a proximal end (7B) of the catheter tube and configured to fluidly couple the catheter tube to a fluid drainage system; a skin fixation member (3) having a through lumen (14) for receiving the catheter tube, a fixation element (13) configured for fixation to the skin of the subject, and a coupling element configured to couple the skin fixation member (3) to the connection hub (10); a removable mobile suction module (4) configured to be removably attached to the connection hub (10); a fluid inlet (19) configured to fluidly couple to the catheter tube (7) through the connection hub (10); a fluid outlet (20) configured to removably fluidly couple to a fluid drainage system (5) for draining pleural fluid through the removable mobile suction module; an actuatable closure member (25) configured to close the fluid outlet when actuated; In an indwelling catheter system comprising: The indwelling catheter system, wherein the removable mobile suction module (4) is configured to apply negative pressure within the catheter tube upon activation of the closure member.

2. 2. The indwelling catheter system of claim 1, wherein the fenestrated distal end (7A) of the catheter tube is configured to reside in the subject's thoracic or abdominal cavity.

3. 2. The indwelling catheter system of claim 1, wherein the actuable closure member (25) is configured to close by removing the fluid drainage system from the removable mobile suction module and to open when the fluid drainage system is attached to the removable mobile suction module.

4. The removable mobile suction module (4) comprises a negative pressure chamber (24); The indwelling catheter system of any one of claims 1 to 3, wherein the fluid inlet (19) is fluidly coupled to the fluid outlet (20) via the negative pressure chamber.

5. The indwelling catheter system of any one of claims 1 to 4, wherein the connection hub (10) is provided with a valve configured to be opened when the connection hub is attached to a removable mobile suction module (4) and configured to be closed when the connection hub is removed from the removable mobile suction module.

6. The indwelling catheter system includes an outer housing (11) configured to be removably attached to the connection hub (10); The indwelling catheter system according to any one of claims 1 to 5, wherein the outer housing (11) is a housing surrounding the connection hub, the housing having a through lumen (15) for receiving the connection hub so as to expose the proximal end (10A) of the connection hub, and a base element (21) configured to abut against the skin of the subject around the skin fixation member (3).

7. 7. The indwelling catheter system of claim 6, wherein the base element (21) of the outer housing (11) is provided with an adhesive for attaching the outer housing to the skin of the subject.

8. The removable mobile suction module (4) has a concave base (18); 8. The indwelling catheter system of claim 6 or 7, wherein the outer housing (11) has an upper surface dimensioned to nest within the concave base of the detachable mobile suction module (4).

9. 9. The indwelling catheter system of claim 8, wherein a fluid inlet (19) of the removable mobile suction module (4) protrudes from the recessed base (18) of the removable mobile suction module (4).

10. the indwelling catheter system is configured to be assembled in a variety of configurations; The above-mentioned configuration includes: a resting configuration, in which the removable mobile suction module (4) is not fluidly connected to the connection hub (10); a drainage arrangement, the removable mobile suction module (4) being fluidly connected to the connection hub (10), the fluid drainage system (5) allowing fluid to be drained under pressure through the indwelling catheter device (2) and the removable mobile suction module (4); a negative pressure therapy arrangement in which the removable mobile suction module (4) is fluidly coupled to the connection hub (10) but not to the fluid drainage system (5) and is subjected to negative pressure; The indwelling catheter system according to any one of claims 1 to 9, comprising:

11. the indwelling catheter system includes a fluid drainage system (5) configured to be fluidly coupled to a fluid outlet (20) of the detachable mobile suction module (4); The indwelling catheter system according to any one of claims 1 to 10, wherein the fluid drainage system comprises a fluid collection container (6) and a pump or negative pressure drainage mechanism.

12. 12. The indwelling catheter system of claim 11, wherein the fluid drainage system comprises a connector having a protruding conduit configured to protrude into the fluid outlet of the removable mobile suction module and to open an actuatable closure member.

13. The indwelling catheter system of any one of claims 1 to 12, wherein the connection hub (10) and / or the outer housing (11) comprises a UV light configured to direct light into the catheter tube and / or to the subject's skin at an incision or an antibacterial coating.

14. 1. An indwelling pleural catheter system, comprising: an indwelling catheter device comprising: a catheter tube having a fenestrated distal end adapted to reside in the subject's thoracic or abdominal cavity; and a connection hub fluidly coupled to a proximal end of the catheter tube; a skin fastening member for fastening the connection hub to the skin of the subject; a removable, mobile suction module configured to be removably mounted to the connection hub; In the indwelling pleural catheter system, The removable mobile suction module comprises: a fluid inlet configured to be fluidly coupled to the catheter tube through the connection hub; a fluid outlet configured to be removably fluidly coupled to a pleural fluid drainage system for draining pleural fluid through a removable mobile suction module; an actuatable closure member configured to close the fluid outlet when actuated; It is equipped with The detachable, mobile suction module is configured to apply negative pressure within the catheter tube upon actuation of the closure member.

15. the removable mobile suction module includes a negative pressure chamber; The indwelling pleural catheter system of claim 14 , wherein the fluid inlet is fluidly coupled to the fluid outlet via the negative pressure chamber.

16. The indwelling pleural catheter system of claim 14 or 15, wherein the actuable closing member (25) is configured to close by removing the pleural fluid drainage system from the removable mobile suction module and to open when the pleural fluid drainage system is attached to the removable mobile suction module.

17. The indwelling pleural catheter system of any one of claims 14 to 16, wherein the connection hub (10) is provided with a valve configured to open when the connection hub is attached to the removable mobile suction module (4) and configured to close when the connection hub is removed from the removable mobile suction module.

18. The indwelling pleural catheter system according to any one of claims 14 to 17, wherein the skin fixation member (3) is separate from the connection hub (10) and configured to be connected to the connection hub (10).

19. The indwelling pleural catheter system according to any one of claims 14 to 18, wherein the skin fixation member (3) is provided with a through lumen (14) for receiving the fenestrated catheter tube.

Images