Point of injury device to stabilize intracranial pressure and method of stabilization

Abstract

A minimally invasive system for monitoring and treating high intracranial pressure levels resulting from traumatic brain injury comprises an intravenous access device, an elongate member, a console, and an aspiration and injection catheter. The system is capable of monitoring pressure levels and relocating fluid from the brain to another part of the patient's body to sustain overall constant fluid volume. The method of using the minimally invasive system is also described.

Claims

1. A system to stabilize intracranial pressure, comprising: an intravenous access device; an elongate member; an aspiration and injection catheter having a first end, a second end, and a third end, the aspiration and injection catheter configured so that the first end and the second end can be positioned at least partially within a mammalian body, and further configured so that the third end can operably connect to a suction or injection device; and a console in communication with the elongate member and configured to obtain data from an electrode section of the elongate member.

2. The system of claim 1, wherein the first end, the second end, and the third end are in fluid communication with each other.

3. The system of claim 1, further comprising: one or more valves positioned within the aspiration and injection catheter, the one or more valves designed to direct flow from at least one of the first end, the second end, or the third end, to another of the first end, the second end, or the third end.

4. The system of claim 1, further comprising: a first valve and a second valve positioned within the aspiration and injection catheter, each of the first valve and the second valve comprising an open and a closed position.

5. The system of claim, 4 wherein when the first valve is open and the second valve is closed, fluid within the aspiration and injection catheter may travel from the first end to the third end.

6. The system of claim 4, wherein when the first valve is closed and the second valve is open, fluid within the aspiration and injection catheter may travel from the third end to the second end.

7. The system of claim 1, wherein the aspiration and injection catheter further comprises a pressure monitor configured to obtain pressure data within the aspiration and injection catheter.

8. The system of claim 1, wherein the aspiration and injection catheter is configured to connect to the intravenous access device.

9. The system of claim 8, wherein the aspiration and injection catheter is in fluid communication with the intravenous access device.

10. A method to stabilize intracranial pressure of a patient, comprising the steps of: placing a first end of an aspiration and injection catheter into a target site of a brain of a patient; placing a second end of the aspiration and injection catheter at a location in a vasculature of the patient and outside of a venous sinus of the brain of the patient; and placing a third end of the aspiration and injection catheter exterior to the patient; wherein the aspiration and injection catheter is configured to facilitate a flow of blood and from the brain of the patient, though the aspiration and injection catheter, and into to the vasculature of the patient.

11. The method claim 10, further comprising the steps of: monitoring intracranial pressure of the patient; and aspirating blood from the brain of the patient when the intracranial pressure is at or above a threshold limit.

12. The method of claim 11, wherein the target site is the venous sinus of the brain of the patient, and wherein the step of aspirating blood is performed to aspirate blood from the venous sinus of the brain of the patient.

13. The method of claim 12, wherein the step of aspirating the blood from the venous sinus of the brain is performed to aspirate the blood into the first end of the aspiration and injection catheter and out of the third end of the aspiration and injection catheter.

14. The method of claim 11, wherein the step of aspirating blood is performed by operating a suction or injection device connected to the third end of the aspiration and injection catheter.

15. A method to stabilize intracranial pressure of a patient, comprising the steps of: advancing an elongate member of a system to a target site of a brain of a patient, the system comprising: an intravenous access device, the elongate member, and an aspiration and injection catheter having a first end, a second end, and a third end, the aspiration and injection catheter configured so that the first end and the second end can be positioned at least partially within a mammalian body, and further configured so that the third end can operably connect to a suction or injection device; advancing at least part of the intravenous access device over at least part of the elongate member; and advancing the aspiration and injection catheter through the intravenous access device such that the first end is at the target site sinus of the brain of the patient, the second end is at a location in the vasculature of the patient and outside the venous sinus, and the third end is exterior of the patient.

16. The method of claim 15, wherein the elongate member is introduced into the patient via an access site on the patient.

17. The method of claim 16, wherein the access site is selected from the group consisting of a radial vein, a cephalic vein, a brachial vein, a basilica vein, and a saphenous vein, in an arm of the patient.

18. The method of claim 15, wherein the elongate member is a conductance guidewire in communication with the console connected thereto, and wherein the step of advancing the elongated member is performed while obtaining conductance information, the conductance information processed by the console and displayed on the console to facilitate advancement of the conductance guidewire.

19. The method of claim 15, wherein the intravenous access device is selected from the group consisting of an indwelling catheter, a peripherally inserted central catheter, and a central venous catheter.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The disclosed embodiments and other features, advantages, and disclosures contained herein, and the matter of attaining them, will become apparent and the present disclosure will be better understood by reference to the following description of various exemplary embodiments of the present disclosure taken in conjunction with the accompanying drawings, wherein:

(2) FIG. 1 shows a guidewire system for navigating to a target site in the brain, according to an exemplary embodiment of the present disclosure;

(3) FIG. 2 shows an exemplary conductance chart of guidewire navigation to the right atrium, according to an exemplary embodiment of the present disclosure;

(4) FIG. 3A shows a fluoroscopic visualization of the present device deployed at a target site, according to an exemplary embodiment of the present disclosure;

(5) FIG. 3B shows a direct visual of the present device deployed at a target site, according to an exemplary embodiment of the present disclosure;

(6) FIG. 4 shows a visual schematic of the device, according to an exemplary embodiment of the present disclosure; and

(7) FIG. 5 shows a block diagram representation of the device, according to an exemplary embodiment of the present disclosure.

(8) An overview of the features, functions and/or configurations of the components depicted in the various figures will now be presented. It should be appreciated that not all of the features of the components of the figures are necessarily described. Some of these non-discussed features, such as various couplers, etc., as well as discussed features are inherent from the figures themselves. Other non-discussed features may be inherent in component geometry and/or configuration.

DETAILED DESCRIPTION

(9) For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of this disclosure is thereby intended. For example, the system is referred to as being used to treat traumatic brain injury, but can be used to monitor and treat increases in intracranial cranial pressure generally. Even further the device could be further applicable to reduce vessel pressure generally.

(10) As described above, the intracranial pressure level can be determined by the rates of cerebrospinal fluid formation and absorption. This is not true in case of head-injured patients with hemorrhage where there is volume-induced rise in intracranial pressure which is not subject to cerebrospinal fluid flow hydrodynamics. There is at least one additional parameter that contributes to the level of intracranial pressure, called the vascular contribution.

(11) The present disclosure provides for a system and method of monitoring and stabilizing the intracranial pressure of an injured patient by monitoring and altering the vascular contribution.

(12) Exemplary System Elements

(13) In one embodiment of the present disclosure, an exemplary system 100 comprises an intravenous access device 102, an elongate member 104, a console 106, and an aspiration and injection catheter 108, such as shown in FIGS. 1, 4, and 5 and referenced in further detail herein.

(14) The intravenous access device 102 is used to obtain access to the patient's bodily lumens, usually the blood vessels 130, from the exterior of the patient. The intravenous access device 102 should be of a diameter such that it can be intraluminally advanced over a guidewire from the access site 124 to the desired target site 122, such as the venous sinuses. The intravenous access device 102 may be an indwelling catheter, and in at least one exemplary one embodiment, the intravenous access device 102 is a peripherally inserted central catheter (PICC), or in another exemplary embodiment, a central venous catheter (CVC).

(15) Similarly, the elongate member 104 may be a guidewire capable of navigating to the venous sinuses or other target site 122. As shown in FIG. 1, the guidewire (an exemplary elongate member 104) may comprise a handle 134 connected to a body, such as long-coiled body around a solid core. The long-coiled body may comprise a floppy or atraumatic distal tip 128 and a stiff proximal end for easy manipulation that is connected to the handle 134. The elongate member 104 may be a conductance guidewire comprising a tetrapolar electrode section 126 for measurement, such as disclosed within U.S. Pat. No. 7,454,244, issued on Nov. 18, 2008 to Kassab et al., the contents of which are hereby incorporated into the present disclosure directly and by reference. The electrode section 126, which can include one, two, three, four, or more electrodes in various embodiments, is preferably located near the distal end of the guidewire and proximal of the atraumatic tip 128. The electrode section 126 may comprise any appropriate number of electrodes 126, and there may be more than one electrode section 126 on the guidewire.

(16) An exemplary console 106 is shown in FIG. 1. The console 106 is in communication with the conductance guidewire and receives conductance information from the guidewire. The console 106 may comprise a computer or processor that interprets the information and displays the interpreted information on a screen display for viewing by the clinician. In a preferred embodiment, the screen display shows increased conductance and oscillations during guidewire advancement in the correct direction towards out target junction, but sustained decreased conductance during guidewire advancement in the incorrect direction away from the junction as in FIG. 2. The clinician can then use the increasing or decreasing oscillations and conductance to accurately navigate the guidewire to a target site 122.

(17) The aspiration and injection catheter 108 is connected to and in fluid communication with the intravenous access device 102. The aspiration and injection catheter 108 may comprise a single catheter, or multiple catheters connected so as to share lumens. The catheter may have a valve or series of valves 118 designed to direct fluid flow from one catheter end to another catheter end. The valve or valves 118 may be open or closed as desired to aspirate or to inject fluid. The aspiration and injection catheter 108 may also have pressure monitors 116 to detect the fluid pressure (pressure data/information) within the connected lumens. The pressure monitors are preferably installed upstream of each valve.

(18) An exemplary aspiration and injection catheter 108 is also shown in FIG. 4. As shown in FIG. 4, the intravenous access device 102 has been introduced over a guidewire into the patient at one of the radial veins and advanced to the venous sinuses of the patient. The aspiration and injection catheter 108 is capable of being placed over the guidewire and connected with the intravenous access device 102.

(19) In the exemplary embodiment depicted in FIG. 4, the aspiration and injection catheter 108 has a first end 110 disposed so as to accept fluid, as in blood, from the venous sinuses. A second end 112 is disposed so as to accept blood from a radial vein in the arm of the patient. A third end 114 is exterior to the patient and accessible to the clinician. The three ends are in fluid communication with each other via a shared lumen junction.

(20) As depicted in FIG. 4, a first valve is placed upstream of the lumen junction 120 towards the first end 110 so that it prevents fluid flow in and out of the first end 110 when closed. A second valve is placed toward the second end 112 and upstream of the lumen junction 120 so that when closed, it prevents fluid flow into or out of the second end 112. The valves 118 are placed upstream so that when the first valve is closed and the second valve opened, fluid may be introduced into the third end 114 and forced to exit the second end 112 into the radial vein, and when the first valve is opened and the second valve is closed, fluid from the first end 110 may be removed via the third end 114 by application of a suctioning force (via a suction or injection device 132) at the third end 114. The introduction and suctioning of fluid may be provided by a syringe (an exemplary suction or injection device 132).

(21) For further clarification, FIG. 5 a block diagram of the system components may be referred to. As shown in FIG. 5, the elongate member 104 and the aspiration and injection catheter 108 interact with the intravenous access device 102, while the elongate member 104 is in communication with the console 106. The four components comprise the system for treating traumatic brain injury 100.

(22) Exemplary Procedure

(23) An exemplary method of using the system to treat secondary traumatic brain injury (e.g. increase in intracranial pressure) comprises the steps of introducing and navigating a guidewire to the a target site 122 in the brain, deploying the intravenous access device 102, deploying the aspiration and injection catheter 108 and monitoring and reducing intracranial pressure as necessary.

(24) Preferably a minimally invasive method such as micropuncture surgery is used to introduce the elongate member 104 or guidewire. Preferred access sites 124 include the radial, cephalic, brachial, basilica, or saphenous veins in the arm of the patient. Other extremities or veins may be used as appropriate or medically necessary. The tip of the guidewire is then advanced to a target site 122, preferably the veins of the brain. Preferably, a conductance guidewire, like the one described above, is used so that navigation is aided by measuring and comparing the parallel conductances of the bodily vessels. Conductance readings can be sent to the console 106 and displayed in real time on an associated screen display. Tip location can be accurately and readily assessed by the clinician and navigation decisions can be made in real time, thereby reducing deployment time.

(25) An exemplary pathway for the elongate member 104 could include initial entry at an access site 124 in the cephalic vein then proceeding into the axillary, brachiocephalic, subclavian superior vena cava and ending in the right atrium. In this exemplary method, each subsequent vein is larger in diameter than the previous. Thus, the measured conductance will show step increases as the guidewire reaches each new, larger vessel, while navigation away from the larger vessels will result in decreases in conductance. A clinician can use these increases and decreases to determine if the guidewire is moving toward or away from a target site 122 in the brain. The point at which there is the largest absolute conductance coupled with large pulsatile conductance changes denotes the location of the cavoatrial junction.

(26) Once the tip of the guidewire has reached the target site 122, the guidewire can be held in place and the intravenous access device 102 can be advanced over the guidewire. If an exemplary guidewire having an electrode section 126 at its distal tip is used, once the intravenous access device 102 covers the electrode section 126, the displayed conductance will drop abruptly to almost zero, signaling to the clinician that the intravenous access device 102 is in place. Where a peripherally inserted central catheter or a central venous catheter has been used, it can be taped to the patient to secure the device.

(27) At this point the aspiration and injection catheter 108 can be connected to or placed into the intravenous access device 102. The associated pressure monitors 116 can be used to observe intracranial pressure. When intracranial pressure gets too high, the appropriate valves 118 may be closed and blood aspirated from the venous of the brain, thereby lowering the cerebrospinal fluid. This blood can be reintroduced into the patient's body by closing the appropriate valves 118 and injecting the blood into the guidewire introduction site which in the exemplary embodiment is the cephalic vein.

(28) The method can be summarized as comprising the steps of accessing the target site 122 via a elongate member 104 introduced into a patient at an access site 124, advancing the guidewire through the vasculature to the target site 122, advancing the intravenous access device 102 to the target site 122 over the guidewire, attaching the aspiration and injection catheter 108 to the intravenous access device 102, taking a pressure measurement, treating the patient by aspirating blood through the intravenous access device 102 and aspiration and injection catheter 108 and reintroducing the blood through the aspiration and injection catheter 108 at the access site 124.

(29) While various embodiments of devices for a point of injury device for monitoring and stabilizing intracranial pressure and methods for treating traumatic brain injury using the same have been described in considerable detail herein, the embodiments are merely offered as non-limiting examples of the disclosure described herein. It will therefore be understood that various changes and modifications may be made, and equivalents may be substituted for elements thereof, without departing from the scope of the present disclosure. The present disclosure is not intended to be exhaustive or limiting with respect to the content thereof.

(30) Further, in describing representative embodiments, the present disclosure may have presented a method and/or a process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth therein, the method or process should not be limited to the particular sequence of steps described, as other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations of the present disclosure. In addition, disclosure directed to a method and/or process should not be limited to the performance of their steps in the order written. Such sequences may be varied and still remain within the scope of the present disclosure.