US-20260124352-A1 - METHODS AND SYSTEMS FOR TREATMENT OF CEREBRAL EDEMA

US20260124352A1US 20260124352 A1US20260124352 A1US 20260124352A1US-20260124352-A1

Abstract

Methods and systems for reduction of cerebral edema including catheter systems. A catheter system includes an elongated main body including a proximal end, a distal end, a central lumen and a plurality of outer lumens extending therethrough and the outer lumens positioned around the central lumen, a hollow fiber portion distal to the main body, and a cap distal to and connected to the hollow fibers. The hollow fiber portion includes a plurality of hollow fibers comprising elongated hollow tubes with semipermeable walls surrounding a drainage catheter. The hollow fibers terminate in the cap which forms a plenum for gas sweeping through the outer lumens and the hollow fibers.

Inventors

Rick M. Odland
Michael R. Wilson
John Borgos

Assignees

INVENTX LLC

Dates

Publication Date: 20260507
Application Date: 20241105

Claims (20)

1 . A catheter system for reduction of cerebral edema comprising a catheter, the catheter comprising: an elongated main body comprising a proximal end, a distal end, a central lumen and a plurality of outer lumens, the central lumen and the outer lumens extending therethrough and the outer lumens positioned around the central lumen; a hollow fiber portion distal to the main body, the hollow fiber portion comprising a plurality of hollow fibers comprising elongated hollow tubes with semipermeable walls, the semipermeable walls being gas permeable and liquid impermeable, the hollow fibers each comprising a proximal end connected to one of the plurality of outer lumens, and a drainage catheter, and the drainage catheter comprising a central lumen, a plurality of pores, the drainage catheter having a proximal end connected to the central lumen of the elongated main body and a distal sealed end, the plurality of hollow fibers are positioned around the drainage catheter; a cap distal to and connected to the hollow fibers, the cap comprising an outer wall that forms a central space into which the hollow fibers extend and terminate at open distal ends, the central space forming a plenum for gas sweeping through the outer lumens and the hollow fibers.
2 . The catheter system of claim 1 , the catheter further comprising a manifold proximal to the main body, wherein the outer lumens split into a first group and a second group lateral to the central lumen.
3 . The catheter system of claim 2 wherein the manifold has an oval cross sectional shape.
4 . The catheter system of claim 1 , the catheter further comprising a drainage catheter extension extending proximally from the manifold.
5 . The catheter system of claim 4 further comprising a trocar comprising an elongated main body, a sheath, and a connector end, wherein the connector end is configured to connect to the drainage catheter extension of the catheter.
6 . The catheter system of claim 5 wherein the sheath is slidably engaged with the trocar main body and configured to slide over and around the manifold of the catheter when the catheter and the trocar are connected.
7 . The catheter system of claim 1 wherein the hollow fibers have an outer diameter between about 100 and about 500 micrometers.
8 . The catheter system of claim 1 wherein the semipermeable walls of the hollow fibers comprise micropores and a permeable material extending over the micropores.
9 . The catheter system of claim 1 further comprising a trocar, the trocar comprising: an elongated main body comprising a first end and a second end, the first end comprising a tip and the second end comprising a connector configured to connect to the proximal end of the catheter main body; and a sheath surrounding the main body and slidable on the main body, the sheath comprising: a neck portion surrounding a portion of the main body and having a circular cross-sectional shape, a shoulder portion which flares outward in one plane to form an expanding oval cross sectional shape, and a tubular sleeve portion extending around and spaced apart from the main body and having a uniform oval cross sectional shape, wherein the shoulder portion is located between the neck portion and the tubular sleeve portion.
10 . The catheter system of claim 9 wherein the shoulder portion flares outward at an angle of between about 30 degrees and about 60 degrees.
11 . The catheter system of claim 9 wherein the connector is configured to fit snugly within the central lumen of the catheter main body.
12 . The catheter system of claim 11 wherein the connector comprises a series of tapered barbs.
13 . The catheter system of claim 9 wherein the elongated main body of the trocar comprises two straight portions connected at an angle.
14 . The catheter system of claim 13 wherein the sheath is located between the angle and the connector of the main body.
15 . A method of treatment of cerebral edema comprising: inserting a distal end of a catheter into a ventricle of a brain of a patient suffering from cerebral edema, the catheter comprising: an elongated main body comprising a proximal end, a distal end, a central lumen and a plurality of outer lumens, the central lumen and the outer lumens extending therethrough and the outer lumens positioned around the central lumen; a hollow fiber portion distal to the main body, the hollow fiber portion comprising a plurality of hollow fibers comprising elongated hollow tubes with semipermeable walls, the semipermeable walls being gas permeable and liquid impermeable, the hollow fibers each comprising a proximal end connected to one of the plurality of outer lumens, and a drainage catheter, and the drainage catheter comprising a central lumen, a plurality of pores, the drainage catheter having a proximal end connected to the central lumen of the elongated main body and a distal sealed end, the plurality of hollow fibers are positioned around the drainage catheter; a cap distal to and connected to the hollow fibers, the cap comprising an outer wall that forms a central space into which the hollow fibers extend and terminate at open distal ends, the central space forming a plenum for gas sweeping through the outer lumens and the hollow fibers; and a manifold connected to the proximal end of the main body, wherein the outer lumens split into a first group and a second group lateral to the central lumen; connecting the catheter to a source of dry gas and a vacuum, the dry gas supplied to the catheter through the first group of outer lumens and the vacuum applied to the catheter through the second group of outer lumens; supplying the dry gas and vacuum to the catheter.
16 . The method of claim 13 wherein the dry gas and the vacuum are supplied continuously.
17 . The method of claim 13 wherein the dry gas and the vacuum are supplied intermittently.
18 . The method of claim 13 further comprising draining cerebrospinal fluid from the ventricle through the central lumen of the main body.
19 . The method of inserting a treatment catheter into a treatment location in a patient, the method comprising: forming a craniotomy hole at a location in the skull of the patient; inserting a first end of a treatment catheter through the craniotomy hole and to a position for treatment, the treatment catheter further comprising a second end which remains external to the patient after this step of inserting the first end; forming a tunnel beneath the scalp of a patient, the tunnel extending from the location of a craniotomy hole to an incision in the scalp at a distance of 2 centimeters or more from the craniotomy hole location; after inserting the first end of the treatment catheter through the craniotomy hole into the position for treatment, attaching the second end of a treatment catheter to a connector end of a trocar; passing the trocar with the attached treatment catheter through the tunnel such that the trocar pulls the second end of the treatment catheter through the tunnel and the second end of the treatment catheter exists the tunnel through the incision; and then detaching the trocar from the treatment catheter.
20 . The method of claim 19 , wherein the second end of the catheter further comprises an external aperture connected to a catheter lumen, the external aperture sealed with a removable plug, the method further comprising: after the second end of the treatment catheter exists the tunnel through the incision, removing the plug from the aperture.

Description

CROSS REFERENCE TO RELATED APPLICATION This application claims priority to U.S. provisional application 63/591,035, filed Oct. 20, 2023, entitled Improved Methods and Systems for Treatment of Cerebral Edema, the disclosure of which is hereby incorporated by reference. BACKGROUND Cerebral edema may be caused by traumatic brain injury (TBI) due to impacts such as motor vehicle accidents, falls, and sports injuries. Other causes of cerebral edema include, for example, brain tumors and infections. In many other areas of the body, tissue swelling may be relatively harmless. However, because the brain is contained within the boney structure of the skull, cerebral edema causes an increase in intracranial pressure (ICP). Because of the fragile nature of brain tissue, elevated ICP can damage the cells of the brain, resulting in permanent brain injury or even death. Therefore, effective treatments to reduce ICP are essential and potentially lifesaving. One method of reducing ICP is removal of a portion of the skull through a craniotomy procedure, thereby providing room for the brain to expand. However, while a craniotomy does reduce ICP, the clinical outcomes for patients are less than desired. Other treatments include hyperosmolar agents. Systemic agents such as mannitol and hypertonic saline are provided to patients intravenously, such as through bolus injections. These hyperosmolar agents cause water movement out of the brain and reduce cerebral edema to a certain extent, but their impact is limited. Other efforts have focused on direct infusion of hyperosmolar agents into the cerebral ventricles, but infusion into the ventricles tends to raise ICP, especially in the noncompliant injured brain. Another method to reduce cerebral edema is to drain off cerebrospinal fluid (CSF) using an External Ventricular Drainage (EVD) catheter. In this method, a catheter is inserted into the ventricle to drain the CSF. In this way, the EVD catheter can successfully reduce the ICP, but the effect may be temporary and, as with other methods, it is unclear how much it improves patient outcomes. Reduction of hydrostatic backpressure by draining ventricular CSF may even worsen cerebral edema. Improved devices and methods are, therefore, needed to reduce cerebral edema as well as intracranial pressure in order to make progress in improving patient outcomes. SUMMARY Various embodiments include catheters system for reduction of cerebral edema comprising a catheter. In some embodiments, the catheters include an elongated main body comprising a proximal end, a distal end, a central lumen and a plurality of outer lumens, the central lumen and the outer lumens extending therethrough and the outer lumens positioned around the central lumen. They also include a hollow fiber portion distal to the main body including a plurality of hollow fibers comprising elongated hollow tubes with semipermeable walls, the semipermeable walls being gas permeable and liquid impermeable, the hollow fibers each comprising a proximal end connected to one of the plurality of outer lumens, and a drainage catheter including a central lumen, a plurality of pores, and having a proximal end connected to the central lumen of the elongated main body and a distal sealed end, with the plurality of hollow fibers are positioned around the drainage catheter. They also include a cap distal to and connected to the hollow fibers, the cap comprising an outer wall that forms a central space into which the hollow fibers extend and terminate at open distal ends, the central space forming a plenum for gas sweeping through the outer lumens and the hollow fibers. In some embodiments, the catheter system of claim 1, the catheter also includes a manifold proximal to the main body, and the outer lumens split into a first group and a second group lateral to the central lumen. The manifold may have an oval cross sectional shape. The catheter system may also include a drainage catheter extension extending proximally from the manifold. In some embodiments, the catheter system may also include a trocar having an elongated main body, a sheath, and a connector end, with the connector end configured to connect to the drainage catheter extension of the catheter. In some such embodiments, the sheath is slidably engaged with the trocar main body and configured to slide over and around the manifold of the catheter when the catheter and the trocar are connected. In some embodiments, the hollow fibers have an outer diameter between about 100 and about 500 micrometers. The semipermeable walls of the hollow fibers may include micropores and a permeable material extending over the micropores. In some embodiments, the catheter system includes a trocar having an elongated main body with a first end and a second end, the first end comprising a tip and the second end comprising a connector configured to connect to the proximal end of the catheter main body, and a sheath surrounding the main body and slidable o