A device for ultrasonic-accelerated hematoma lysis or thrombolysis of intracerebral or intraventricular hemorrhages or hematomas

Abstract

The present invention relates to a device for ultrasonic-accelerated hematoma lysis or thrombolysis of intracerebral or intraventricular hemorrhages or hematomas, comprising a body which accommodates a number of separated compartments or lumens consisting of a flushing catheter for flushing fluid and/or pharmaceutically active substances into the intracerebral or intraventricular hemorrhages or hematomas, a drainage catheter for draining fluid from the intracerebral or intraventricular hemorrhages or hematomas, an ultrasonic probe duct, and a pressure sensor duct, wherein the compartments or lumens are arranged in proximity to each other and wherein in longitudinal extension at least upper-part sections of the compartments or lumens are isolated by walls, wherein the lumen of the pressure sensor duct integrates a pressure sensor, and wherein in the lumen of ultrasonic probe duct an endosonographic probe or a stiletto is interchangeably guided.

Claims

1. A device for ultrasonic-accelerated hematoma lysis or thrombolysis of intracerebral or intraventricular hemorrhages or hematomas, comprising a body (20) which accommodates a number of separated compartments or lumens forming a flushing catheter (1) for flushing fluid and/or pharmaceutically active substances into the intracerebral or intraventricular hemorrhages or hematomas, a drainage catheter (2) for draining fluid from the intracerebral or intraventricular hemorrhages or hematomas, an ultrasonic probe duct (3), and a pressure sensor duct (5), wherein the compartments or lumens are arranged in proximity to each other and wherein in longitudinal extension at least upper proximal part sections of the compartments or lumens are isolated by walls, wherein the lumen of the pressure sensor duct (5) integrates a pressure sensor (6), and wherein in the lumen of the ultrasonic probe duct (3) an endosonographic probe (4) is guided.

2. The device according to claim 1, wherein an upper proximal part portion (1.1) of the flushing catheter (1) and/or upper proximal part portion (2.1) of the drainage catheter (2) laterally projects from the body (20) in bended form.

3. The device according to claim 1, wherein in a lower distal part (2.2) of the body (20), an outer wall of the drainage catheter (2) comprises apertures (8).

4. The device according to claim 1, wherein in lower distal parts (1.2, 2.2) of the body (20), the drainage catheter (2) and the flushing catheter (1) are permeably connected by one or more penetrations (7).

5. The device according to claim 1, wherein the ultrasonic probe duct (3) is arranged oppositely to the drainage catheter (2), and wherein at least a section of the flushing catheter (1) is arranged between the drainage catheter (2) and the ultrasonic probe duct (3).

6. The device according to claim 1, wherein the pressure sensor duct (5) that integrates the pressure sensor (6) is arranged at an outer part of the body (20).

7. The device according to claim 1, wherein an outside part of the body (20) comprises a connector (9) for cranial fixation, which is adapted to allow an angular adjustment of the body (20) in longitudinal and/or transverse direction.

8. The device according to claim 1, wherein an outer wall of the ultrasonic probe duct (3) further comprises a membrane 16 at a lower distal part (1.2) portion of the body (20), which is permeable for ultrasonic energy.

9. The device according to claim 1, wherein the endosonographic probe (4) inserted into the ultrasonic probe duct (3) emits at frequencies between 5.5 and 10 MHz, preferably 10 MHz.

10. The device according to claim 1, wherein instead of an endosonographic probe (4), a stiletto (13) is interchangeably guided in the ultrasonic probe duct (3) and wherein the stiletto (13) is optionally equipped with a marker of neuronavigation (14).

11. The device according to claim 1, wherein the pressure sensor (6) is part of a pole having a diameter which allows guidance in the pressure probe duct (5), wherein the pressure sensor (6) is arranged at a cone end of the pole.

12. The device according to claim 1, wherein the pharmaceutically active substances are thrombolytics.

13. A method of treatment of intracerebral or intraventricular hemorrhages or hematomas comprising: applying a catheter system which comprises a body which accommodates a number of separated compartments or lumens forming a flushing catheter for flushing fluid and/or pharmaceutically active substances into the intracerebral or intraventricular hemorrhages or hematomas, a drainage catheter for draining fluid from the intracerebral or intraventricular hemorrhages or hematomas, an ultrasonic probe duct, and a pressure sensor duct, wherein the compartments or lumens are arranged in proximity to each other and wherein in longitudinal extension at least upper proximal part sections of the compartments or lumens are isolated by walls, wherein the lumen of the pressure sensor duct integrates a pressure sensor (6), and wherein in the lumen of the ultrasonic probe duct, an endosonographic probe is guided, flushing fluid and/or pharmaceutically active substances through the flushing catheter which forms an integral part of the body of the catheter system into the intracerebral or intraventricular hemorrhages or hematomas, draining fluid from the intracerebral or intraventricular hemorrhages or hematomas through the drainage catheter which forms an integral part of the body of the catheter system, guiding a stiletto within the ultrasonic probe duct which is arranged next to the flushing catheter and the drainage catheter in the body of the catheter system for intracranial placement of the catheter system, changing the stiletto against the endosonographic probe and guiding the endosonographic probe within the ultrasonic probe duct, and inserting a pressure probe into the pressure sensor duct of the body of the catheter system for monitoring intracranial pressure during flushing and hematoma lysis.

14. The method according to claim 13, wherein the pharmaceutically active substances flushed into the intracerebral or intraventricular hemorrhages or hematomas by means of the flushing catheter are thrombolytics.

15. The method according to claim 13, wherein the endosonographic probe is used for ultrasonic lysis and real-time imaging of the intracerebral or intraventricular hemorrhages or hematomas.

16. The device according to claim 12, wherein the thrombolytics are recombinant tissue plasminogen activator (rtPA), streptokinase, p-anisoylated lys-plasminogen-streptokinase activator complex, urokinase, or prourokinase.

17. The method according to claim 14, wherein the thrombolytics are such as recombinant tissue plasminogen activator (rtPA), streptokinase, p-anisoylated lys-plasminogen-streptokinase activator complex, urokinase, or prourokinase.

Description

BEST MODE FOR CARRYING OUT THE INVENTION

[0043] The present invention is illustrated in more detail in the accompanying figures.

[0044] FIG. 1 shows an embodiment of the sonothrombolytic catheter system according to the present invention. The device is comprised of a body 20 that accommodates different compartments or lumens that are arranged in proximity to each other and are separated from each other by respective walls. Basically, the device of the invention contains several catheters forming a catheter system that includes different functions. The first compartment or lumen is part of a flushing catheter 1 for flushing fluid and/or pharmaceutically active substances into the intracerebral or intraventricular hemorrhages or hematomas. Preferably, rtPA or other thrombolytic substances are applied to the site of ICH or IVH by means of the flushing catheter 1. The body 20 further accommodates a compartment or lumen of a drainage catheter 2 for draining fluid from the ICH or IVH. The body 20 also comprises a compartment or lumen of an ultrasonic probe duct 3 and a separate pressure sensor duct 5. The lumen of the pressure sensor duct 5 integrates a pressure sensor 6, preferably at the cone end of a pole 15 for measurement and analysis of intracranial pressures during implantation and treatment of ICH or IVH. The ultrasonic probe duct 3 both comprises either an endosonographic probe 4 (FIG. 1) or a stiletto 13 (FIG. 2) that can be interchangeably guided within the ultrasonic probe duct 3. The upper proximal portion 1.1 of the flushing catheter 1 and/or the upper proximal portion 2.1 of the drainage catheter 2 laterally project from the body 20 in bended form. The lower distal portion 1.2 of the flushing catheter 1 and/or the lower distal portion 2.2 of the drainage catheter 2 are provided in straight form.

[0045] In the lower distal part of the body 20, the outer wall of the drainage catheter 2 comprises one or more apertures 8. Fluid or debris is flushed from the site of ICH or IVH through the catheter lumen to the upper end of the drainage catheter 2. The upper proximal portion 1.1 of the flushing catheter 1 and/or the upper proximal portion 2.1 of the drainage catheter 2 is equipped with adapters 11 or ports 12, respectively.

[0046] In the lower part of the body 20, the lumen of the flushing catheter 1 is penetrated such that flushing fluid from the flushing catheter 1 flows into the lower distal part portion 2.2 of the drainage catheter 2 through one or more penetrations 7.

[0047] The body 20 also comprises a connector 9 for cranial fixation, which is adapted to allow an angular adjustment of the body 20 in longitudinal and/or transverse direction. The connector 9 is integrated into a hole of a skull 10.

[0048] In a preferred embodiment, the circular lateral wall of the ultrasonic probe duct 3 further comprises a membrane 16, which is permeable for ultrasound. Furthermore, it is preferred that the endosonographic probe 4 is rotatable within the ultrasonic probe duct 3.

[0049] FIG. 2 shows a replacement of the endosonographic probe 4 by a stiletto 13 which is required for implantation into the ICH or IVH. The stiletto 13 provides stiffness for the implantation of the catheter system and also may comprise additional markers of neuronavigation 14 at the upper end, such as reflective marker spheres.