Patent ID: 12239426

DETAILED DESCRIPTION

The presently disclosed subject matter now will be described more fully hereinafter with reference to the accompanying Drawings, in which some, but not all embodiments of the inventions are shown. Like numbers refer to like elements throughout. The presently disclosed subject matter may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Indeed, many modifications and other embodiments of the presently disclosed subject matter set forth herein will come to mind to one skilled in the art to which the presently disclosed subject matter pertains, having the benefit of the teachings presented in the foregoing descriptions and the associated Drawings. Therefore, it is to be understood that the presently disclosed subject matter is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims.

The present disclosure relates generally to controlling a volume of fluid within a portion of a patient's body and, more specifically, to systems and methods for controlling a volume of fluid within a portion of a patient's body using a dual channel probe. The dual channel probe can include a drain element and a volume changing element. For example, the drain element can be a ventricular shunt to drain the fluid from the portion of the patient's body, while the volume changing element can expand and contract to change a volume of the portion of the patient's body. The expansion and contraction of the volume changing element can be controlled by a passive volume control system or an active volume control system.

The fluid removal device is unique because it combines the drain element and the volume changing element. The combination of the drain element and the volume changing element can provide at least two methods of changing the pressure within the portion of the patient's body, as well as changing the compliance of the patient's body. The fluid removal device can maximize movement of the fluid from the portion of the patient's body and, in turn, maximize blood flow in the portion of the patient's body. Accordingly, the fluid removal device can be used in the treatment of various diseases where fluid removal is required, such as dementia and other acute and chronic low blood flow states. The fluid removal device can also be used for drug delivery, for example, for tumors, epilepsy, and other neurological diseases.

One aspect of the present disclosure can include a system10that can control an amount of a fluid within a portion of a patient's body. As an example, the system can remove cerebrospinal fluid (CSF) from CSF space within the patient's brain or spinal cord. By adding or removing CSF, the system10can treat ailments including altered intracranial compliance, decreased cerebral blood flow, and/or abnormal intracranial pressure. Such conditions can occur with head injuries, aging, cerebrovascular disease, brain atrophy, post brain hemorrhage and infection, vasospasms, congestive heart failure, carotid endarterectomy, carotid occlusion/stenosis, cardiopulmonary bypass procedure, hydrocephalus, stroke, dementia, or migraine headaches. Hydrocephalus can be chronic hydrocephalus, normal pressure hydrocephalus, pseudotumor, cerebri, or slit ventricle syndrome.

The system10can include a dual chamber probe12, which can include a drain element14in the first chamber and a volume changing element16in the second chamber. It will be understood that the dual chamber probe12may have additional chambers and is not limited to just two chambers. In some instances, when the system10is configured to control an amount of cerebrospinal fluid (CSF) from CSF space (e.g., a ventricle) within the patient's brain or spinal cord, the dual chamber probe12can be in the form of a catheter. For example, the catheter can be a ventricular catheter that includes a length of biocompatible tubing with a plurality of holes formed therethrough. The catheter (dual chamber probe12) can be a multi-lumen catheter with the drain element14being a first lumen and the volume changing element16being a second lumen. For example, the second lumen can include a deformable element (e.g., a bag, a bladder, a balloon, or the like) that expands and contracts by inflation and deflation to change the volume of the CSF space to facilitate drainage of an amount of CSF by the first lumen. In other words, the two lumen of the catheter can operate together to drain an amount of CSF from the patient's brain, for example, to maximize cerebral blood flow or other cerebral or spinal property. In some examples, second lumen can be located at a tip of the distal end of the catheter.

In the general sense, the dual chamber probe12can include a drain element14, which can drain the fluid from the portion of the patient's body or add the fluid to the portion of the patient's body. In some instances, the drain element14can be a passive drain. For example, the drain element14can have an open distal end that can be inserted into the portion of the patient's body to receive and drain the fluid. The other end of the drain element14can be in fluid communication with a flexible tube, which can carry the fluid out of or into the patient's body. The flexible tube can be connected to a fluid reservoir18, which can be either external to the patient's body or internal to the patient's body (e.g., within the patient's abdomen). The fluid reservoir18can hold the drained fluid. In other instances, the drain element14can be in two-way communication with the fluid reservoir18. In other words, the fluid reservoir18can include the fluid that can be added to the portion of the patient's body. The drain element14can be used to add the fluid to the portion of the patient's body.

The addition and removal of the fluid by the drain element14can be used to modulate the volume of the portion of the patient's body (e.g., modulating the volume of CSF space in the patient's brain or spinal cord). The addition and removal can be facilitated by a change in volume of the portion of the patient's body. Accordingly, the dual chamber probe12can include a volume changing element16can expand and contract to modulate the volume of the portion of the patient's body. For example, the volume changing element16can expand and contract to modulate the volume as much as 2 cubic centimeter (“cc”). In other examples, the volume changing element16can expand and contract to modulate the volume as much as 1.5 cc. In still other examples, the volume changing element16can expand and contract to modulate the volume as much as 1 cc. The changing volume can facilitate the drainage (or addition) of the fluid from the portion of the patient's body through the drain element14.

In some instances, the volume changing element16can include a deformable element (e.g., a bag, a bladder, a balloon, or the like) that expands and contracts by inflation and deflation to change the volume of the portion of the patient's body. The volume changing element16can expand and contract to any size depending on the application, the patient, and/or the portion of the patient's body to facilitate removal of the fluid from the portion of the patient's body. As an example, the volume changing element16can inflate to a length of about 10 to about 50 mm and a width of about 5 mm to about 20 mm. As another example, the volume changing element16can inflate to a length of about 5 mm to about 10 mm and a width of about 1 mm to about 10 mm.

The volume changing element16can be communicatively coupled to a volume control19. For example, the volume changing element16and the volume control19can be coupled together with a substance. In other words, the volume changing element16and at least a portion of the volume control19(as well as the connection between the two) can include a substance, like a fluid (e.g., a biocompatible fluid like saline), a gas, or another malleable substance. Movement of the substance (e.g., triggered by the volume control19) can trigger the volume changing element16to inflate or deflate. The volume control19can be located internal to the patient's body and/or external to the patient's body. In some examples, a portion of the volume control19can be located internal to the patient's body and another portion of the volume control19can be located external to the patient's body.

As shown inFIG.2, the volume control19acan be a passive system. The passive volume control19acan include, for example, an oscillator22, a reservoir24, and an output28to the volume changing element16. The oscillator22can be operational to control the change of the volume of the portion of the patient's body by oscillating at a set oscillation frequency. In other words, the oscillator22can regulate the expansion and contraction of the volume changing element16to change the volume of the patient's body. When the oscillator22oscillates, the reservoir24can output a portion of the substance within to the volume changing element16through the output26. In some instances, the output26of the passive volume control19acan also input the substance to the reservoir24from the volume changing element16during other portions of the oscillation.

As shown inFIG.3, the volume control19bcan be an active system. The active volume control19bcan signal the volume changing element16to inflate or deflate in response to the input biorhythm. By controlling the change of the volume of the portion of the patient's body, based on the detected biorhythm, the volume control19bcan ensure that a proper amount of fluid is located within the volume of the patient's body

The active volume control19bcan include an input30, which receives am input signal from at least one sensor. The at least one sensor can detect at least one parameter corresponding to the biorhythm. Examples of biorhythms include a cardiac rhythm of the patient, a cardiac cycle of the patient, a cardiac sequence of the patient, an electrocardiogram of the patient, a pulse oximetry of the patient, a respiratory rate of the patient, or the like. The input30can send the signal (either preprocessed or raw) to a controller32.

The controller32can employ an algorithm to trigger the oscillator34to oscillate so that the reservoir36releases the substance as an output through output38to the volume changing element16. In some instances, the output38of the active volume control19bcan also input the substance to the reservoir36from the volume changing element16. The oscillator34, in some instances, can also include a pump (e.g., piston, rotary centrifugal, roller, peristaltic pump, etc.) to pump the fluid, gas, or malleable fluid between the reservoir36and the volume changing element16. The pump can be operational in response to the input or the pumping can operate as a function of the input.

Another aspect of the present disclosure can include methods40,50for fluid control within a portion of a patient's body, as shown inFIGS.4-5. As an example, the fluid control of methods40-50can be accomplished using the dual chamber probe12of system10, as shown inFIG.1, which includes a drain element14and a volume changing element16coupled to a volume control19(either active or passive) that operate together to facilitate the fluid removal. The volume can be controlled to facilitate more efficient and physiological fluid removal, to enhance or decrease brain pressure waveforms to effect fluid removal, brain equilibrium, compliance, and/or blood flow, and/or to allow substance delivery under conditions of variable intracranial pressure. The volume of the fluid can be changed in the portion of the patient's body through removal or addition of fluid through the dual channel probe as an open system or a closed system. For example, the open system can remove fluid with simultaneous volume equilibrium for brain homeostasis. The fluid removal can be facilitated with a volume changer. As another example, the fluid removal in the closed system can be based on a biorhythm, such that fluid is added and removed simultaneously to an increase or decrease of a biological parameter (e.g., shown in cyclic pressure waveforms occurring with a cardiac or respiratory body rhythm).

The methods40-50are illustrated as process flow diagrams with flowchart illustrations. For purposes of simplicity, the methods40-50are shown and described as being executed serially; however, it is to be understood and appreciated that the present disclosure is not limited by the illustrated order as some steps could occur in different orders and/or concurrently with other steps shown and described herein. Moreover, not all illustrated aspects may be required to implement the methods40-50.

FIG.4illustrates a method40for fluid removal from a portion of a patient's body. In some instances, the fluid can be excess CSF located within the patient's brain (e.g., in a vesicle of the patient's brain) or spinal cord. At42, a dual channel probe (e.g., dual chamber probe12) can be inserted into the portion of the patient's body. At44, the volume of the portion of the patient's body can be changed. For example, the volume changing element16of the dual chamber probe12can expand or contract to change the volume of the portion of the patient's body. As an example, the volume changing element16can expand or contract in response to receiving a substance (e.g., a fluid, a gas, a malleable substance, or the like) from a volume control19(e.g., in response to oscillations, either active or passive). At46, an amount of fluid can be added to or removed from the portion of the patient's body (e.g., through drain element14of dual chamber probe12). The addition or removal of the amount of fluid can maximize blood flow through the portion of the patient's body or increase compliance of the portion of the patient's body.

The addition or removal can be facilitated by the volume changing element16of the dual chamber probe12. For example, the volume changing element16can expand or contract to change the volume of the portion of the patient's body (e.g., modulating the volume by as much as 2 cc) so that the drainage occurs through the drain element14. In some instances, when the volume control19is an active volume control. the expansion and contraction can be coordinated with a biological input (e.g., a cardiac rhythm of the patient, a cardiac cycle of the patient, a cardiac sequence of the patient, an electrocardiogram of the patient, a pulse oximetry of the patient, a respiratory rate of the patient, a biorhythm of the patent, or the like).

A method50for active volume control (e.g., by active volume control19bofFIG.3) is shown inFIG.5. At52, a signal (e.g., including a biological input, related to a cardiac rhythm of the patient, a cardiac cycle of the patient, a cardiac sequence of the patient, an electrocardiogram of the patient, a pulse oximetry of the patient, a respiratory rate of the patient, a biorhythm of the patent, or the like) can be received (e.g., by input30of active volume control19b). At54, an oscillation (e.g., by oscillator34) can be created in response to the signal (e.g., based on an algorithm employed controller32). The algorithm can, for example, set a threshold over which the oscillator is to oscillate. The threshold can vary based on the number of sensors detecting the biorhythms, the biorhythms being detected, the application, the patient, and the amount of fluid in the part of the patient's body. At56, a volume of a portion of the patient's body can be changed (e.g., by inflation or deflation of the volume changing element16) based on the oscillation. For example, the oscillation can trigger a substance to be output (by output38) from the reservoir36to inflate the volume changing element16. In another example, the oscillation can trigger the substance to be input (by output38) to the reservoir36. This control can allow the volume of the portion of the patient's body to be controlled so that a certain amount of fluid can be added or removed (e.g., by drain element14).

FIG.6Aillustrates a partially sectional view of a catheter according to an embodiment of the present invention, andFIG.6Billustrates a cross sectional view ofFIG.6Ataken along axis A-A′. As illustrated inFIGS.6A and6Bthe device100includes a catheter102. Catheter102includes fluid injection and drainage ports104. Fluid injection and drainage ports104are defined by a wall106of the catheter102. Inflatable balloons108are positioned on an external surface of the catheter102. Air flow into the balloons106is provided through a conduit110either defined by or adjacent to the wall of the catheter102. The air flow into the balloons108is gaited to cardiac pulse. Further, CSF drainage or fluid injection can be achieved with the catheter102and the fluid injection and drainage ports104. The fluid injection and drainage ports are in fluid communication with a drain and/or a source of sterile fluid for injecting into the space. The balloons108are also used to modulate the volume in the space, especially depending on pulse and other fluctuations in volume.

The many features and advantages of the invention are apparent from the detailed specification, and thus it is intended by the appended claims to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.