US-12623052-B2 - Indwelling catheter system

US12623052B2US 12623052 B2US12623052 B2US 12623052B2US-12623052-B2

Abstract

An indwelling pleural catheter system comprises an indwelling catheter device ( 2 ) comprising a catheter tube ( 7 ) with a fenestrated distal end ( 7 A) configured to reside in the pleural cavity of a subject and a connection hub ( 10 ) fluidically coupled to a proximal end ( 7 B) of the catheter tube, a skin anchoring member ( 3 ) to anchor the connection hub ( 10 ) to the skin of the subject, and optionally a detachable ambulatory suction module ( 4 ) configured for detachable attachment to the connection hub ( 10 ). The suction module ( 4 ) comprises a fluid inlet ( 19 ) configured for fluidic coupling to the catheter tube ( 7 ) through the connection hub ( 10 ) and a fluid outlet ( 20 ) configured for detachable fluidic coupling to a pleural fluid drainage system ( 5 ) to drain pleural fluid through the detachable ambulatory suction module. The detachable ambulatory suction module is configured to exert a negative pressure in the catheter tube upon detachment of the pleural fluid drainage system from the suction module. Treatment of pleural effusion using the system of the invention is described. An indwelling catheter system for draining fluid from the peritoneal cavity, and methods of treating ascites, is also described.

Inventors

Richard MODLEY
Tim Jones
Michelle TIERNEY

Assignees

University of Galway

Dates

Publication Date: 20260512
Application Date: 20231116
Priority Date: 20200530

Claims (20)

1 . An indwelling catheter system for draining fluid from a body cavity of a subject defined by a parietal membrane and a visceral membrane, comprising: an indwelling catheter device ( 2 ) comprising a catheter tube ( 7 ) with a fenestrated distal end ( 7 A) configured to reside in the cavity of the subject and a connection hub ( 10 ) disposed on a proximal end ( 7 B) of the catheter tube and configured to fluidically couple the catheter tube with a fluid drainage system; a detachable ambulatory suction module ( 4 ) configured for detachable attachment to the connection hub ( 10 ) and comprising: a fluid inlet ( 19 ) configured for fluidic coupling to the catheter tube ( 7 ) through the connection hub ( 10 ); a fluid outlet ( 20 ) configured for detachable fluidic coupling to a fluid drainage system to drain pleural fluid through the detachable ambulatory suction module; and an actuable closure ( 25 ) configured to close the fluid outlet upon actuation, wherein the detachable ambulatory suction module is configured to exert a negative pressure in the catheter tube upon actuation of the closure; an external housing ( 11 ) configured for detachable attachment to the connection hub ( 10 ) and comprising a connection hub embracing housing with a through lumen ( 15 ) for receipt of the connection hub ( 10 ) to expose a proximal end ( 10 A) of the connection hub and a base element ( 21 ) configured to abut the skin of the subject, and wherein the detachable suction module ( 4 ) has a recessed base ( 18 ) and the external housing ( 11 ) has an upper surface dimensioned to nest within the recessed base of the detachable suction module ( 4 ).
2 . The indwelling catheter system according to claim 1 , wherein the base element comprises an adhesive member for attaching the external housing to the skin of the subject.
3 . The indwelling catheter system according to claim 1 , in which the fenestrated distal end ( 7 A) of the catheter tube is configured to reside in the pleural cavity or peritoneal cavity of a subject.
4 . The indwelling catheter system according to claim 1 , wherein the actuable closure ( 25 ) is configured to close by detachment of the fluid drainage system from the detachable ambulatory suction module and open upon attachment of the fluid drainage system and the detachable ambulatory suction module.
5 . The indwelling catheter system according to claim 1 , in which 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 ) by the negative pressure chamber.
6 . The indwelling catheter system according to claim 5 , in which the negative pressure chamber has a volume of at least 10 cc.
7 . The indwelling catheter system according to claim 1 , in which the detachable ambulatory suction module ( 4 ) comprises a bleed valve ( 22 ) configured to exert a threshold negative pressure in the catheter tube ( 7 ) upon detachment of the pleural fluid drainage system ( 5 ) from the detachable ambulatory suction module ( 4 ).
8 . The indwelling catheter system according to claim 7 , in which the bleed valve ( 22 ) is configured to maintain a threshold negative pressure in the ambulatory suction module ( 4 ) of 20-300 mmHg.
9 . The indwelling catheter system according to claim 1 , in which the connection hub ( 10 ) comprises a valve configured to open upon attachment of the connection hub with the detachable suction module ( 4 ) and close upon detachment of the connection hub with the detachable suction module.
10 . The indwelling catheter system according to claim 1 , in which the base element ( 21 ) of the external housing ( 11 ) comprises an adhesive dressing for attaching the external housing to the skin of the subject.
11 . The indwelling catheter system according to claim 1 , in which the fluid inlet ( 19 ) of the detachable suction module ( 4 ) projects proud of the recessed base ( 18 ) of detachable suction module ( 4 ).
12 . The indwelling catheter system according to claim 1 , configured for assembly into a number of different configurations including: a resting configuration in which the detachable suction module ( 4 ) is not fluidically connected to the connection hub ( 10 ); a drainage configuration in which the detachable suction module ( 4 ) is fluidically connected to the connection hub ( 10 ) and the fluid drainage system ( 5 ) allowing drainage of fluid under pressure through the catheter device ( 2 ) and detachable ambulatory suction module ( 4 ); and a negative pressure therapy configuration in which the detachable suction module ( 4 ) is fluidically coupled to the connection hub ( 10 ), not fluidically coupled to the fluid drainage system ( 5 ), and negatively pressurized.
13 . The indwelling catheter system according to claim 1 , including a fluid drainage system ( 5 ) configured for fluidic coupling to the outlet ( 20 ) of the detachable suction module ( 4 ), the fluid drainage system comprising a fluid collection vessel ( 6 ) and a pump or negatively pressurised drainage mechanism.
14 . The indwelling catheter system according to claim 13 , in which the fluid drainage system comprises a connector with a projecting conduit configured to project into the fluid outlet of the ambulatory suction module and open the actuable closure.
15 . The indwelling catheter system according to claim 1 , in which the actuable closure comprises a duck bill valve.
16 . The indwelling catheter system according to claim 1 , in which the connection hub ( 10 ) and/or external housing ( 11 ) comprise a UV light configured to direct light on the catheter tube and/or the subject skin at the incision or an antibacterial coating.
17 . An indwelling pleural catheter system comprising: an indwelling catheter device comprising a catheter tube with a fenestrated distal end configured to reside in the pleural or peritoneal cavity of a subject and a connection hub fluidically coupled to a proximal end of the catheter tube; a detachable ambulatory suction module configured for detachable attachment to the connection hub and comprising: a fluid inlet configured for fluidic coupling to the catheter tube through the connection hub; a fluid outlet configured for detachable fluidic coupling to a pleural fluid drainage system to drain pleural fluid through the detachable ambulatory suction module; and an actuable closure configured to close the fluid outlet upon actuation, wherein the detachable ambulatory suction module is configured to exert a negative pressure in the catheter tube upon actuation of the closure; an external housing ( 11 ) configured for detachable attachment to the connection hub ( 10 ) and comprising a connection hub embracing housing with a through lumen ( 15 ) for receipt of the connection hub ( 10 ) to expose a proximal end ( 10 A) of the connection hub and a base element ( 21 ) configured to abut the skin of the subject, and wherein the detachable suction module ( 4 ) has a recessed base ( 18 ) and the external housing ( 11 ) has an upper surface dimensioned to nest within the recessed base of the detachable suction module ( 4 ).
18 . The indwelling pleural catheter system according to claim 17 , in which the detachable ambulatory suction module comprises a negative pressure chamber, wherein the fluid inlet is fluidically coupled to the fluid outlet by the negative pressure chamber.
19 . The indwelling pleural catheter system according to claim 17 , wherein the actuable closure ( 25 ) is configured to close by detachment of the fluid drainage system from the detachable ambulatory suction module and open upon attachment of the fluid drainage system and the detachable ambulatory suction module.
20 . The indwelling pleural catheter system according to claim 18 , in which the negative pressure chamber has a volume of at least 10 cc.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation application of Ser. No. 17/928,785 filed Nov. 30, 2022, which is a 35 U.S.C. § 371 U.S. national phase entry of International Patent Application No. PCT/EP2021/064428 having an international filing date of May 28, 2021, which claims the benefit of European Patent Application No. 20177632.5 filed May 30, 2020, each of which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION The present invention relates to an indwelling catheter system. The invention also relates to a method of treating a pleural effusion in a subject that employs an indwelling pleural catheter system BACKGROUND TO THE INVENTION A pleural effusion is a condition characterised by a build-up of excess fluid in the pleural cavity, the cavity defined by the parietal and visceral membranes that surround the lungs and act to lubricate and facilitate breathing. Normally the pleural cavity contains a small amount of fluid. An excess of fluid can cause chest pain, cough, dyspnea and orthopnea. The condition can be caused by many factors, including heart failure, pulmonary embolism, cirrhosis, and open-heart surgery. Other causes include pneumonia, cancer, kidney disease, and inflammatory conditions. Common treatments for pleural effusion include thoracentesis (removal of fluid using a syringe), tube thoracostomy (removal of fluid using a chest tube which remains in situ for several days), pleural drain (removal of fluid using a long-term indwelling catheter), and a pleurodesis procedure. The latter involves irritating the pleural membranes, either chemically or mechanically, and has a success rate of 70-90% resulting in the prevention of recurrence of pleural effusions. The treatment is highly invasive, requires lengthy hospitalisation, and is contraindicated for patients with a trapped lung. The insertion of an indwelling pleural catheter (IPC) provides is a less invasive, ambulatory alternative compared to the pleurodesis procedure to manage effusions. However, IPC insertion does require an invasive tunnelling procedure, involving two incisions being made, to secure the catheter under the skin. Furthermore, current IPCs are designed to drain the pleural fluid only and, do not contain dedicated mechanisms to prevent fluid from reaccumulating. As a result, many people being treated with IPCs may have them in place for up to a year. It is an object of the invention to overcome at least one of the above-referenced problems. SUMMARY OF THE INVENTION The Applicant has addressed the problems of the prior art by providing an indwelling pleural catheter system that can perform pleural fluid drainage and also promote pleurodesis by the extended application of negative pressure therapy to the pleural cavity after a drainage step. The application of negative pressure to the pleural cavity using an indwelling catheter functions to draw the parietal and visceral membranes together promoting pleurodesis. The catheter system comprises a fenestrated catheter tube configured for placement within the pleural cavity with a connection hub at a proximal end, and a detachable suction module configured to attach to the connection hub that is adjustable between three configurations. In a first configuration (drainage), the suction module provides fluidic connection between the connection hub and the pressurised drainage system, and pleural fluid is drained under pressure through the suction module. In a second configuration (negative pressure therapy), the drainage system is detached from the suction module, but the suction module remains negatively pressurised and exerts a negative pressure in the catheter tube, applying a negative pressure therapy to the pleural cavity. A third configuration (resting) comprises detachment of the suction module from the connection hub, maintaining the negative pressure in the catheter tube. In another aspect, the invention provides a catheter system for draining fluid from a cavity in a subject defined by parietal and visceral membranes (for example a pleural or peritoneal cavity). In a first aspect, the invention provides an indwelling pleural catheter system comprising: an indwelling catheter device comprising a catheter tube with a fenestrated distal end configured to reside in the pleural cavity of a subject and a connection hub fluidically coupled to a proximal end of the catheter tube;a skin anchoring member to anchor the connection hub to the skin of the subject; anda detachable ambulatory suction module configured for detachable attachment to the connection hub and comprising: a fluid inlet configured for fluidic coupling to the catheter tube through the connection hub;a fluid outlet configured for detachable fluidic coupling to a pleural fluid drainage system to drain pleural fluid through the detachable ambulatory suction module; andtypically an actuable closure configured to close the fluid outlet upon actuation,