ACUTE CEREBROSPINAL FLUID MANAGEMENT IMPLANT

FIELD OF THE DISCLOSURE

The present disclosure relates generally to systems and methods for holistic electrical ultrasonic and physiological interventions unburdening those with spinal cord injuries (HEPIUS). More particularly, the present disclosure relates to systems and methods for acute cerebrospinal fluid management.

BACKGROUND OF THE DISCLOSURE

Few viable treatment options are available for patients who have suffered a traumatic injury, such as a spinal cord injury (SCI), brain injury, burn injury, or another type of serious injury. Spinal cord injury can be a devastating condition with lifelong complications. Spinal cord injury monitoring and interventions remain in their infancy compared with advances made for other types of injuries. For example, monitoring of intracranial pressure and tissue oxygenation are mainstays in the treatment of acute traumatic brain injury (TBI), and information gathered from this monitoring is also helpful in the prevention and mitigation of secondary injury. Similar to TBI, SCI leads to severed axons, glial scarring, and a global lack of innate regenerative capacity at the injury site during the acute phase. Secondary injury is common due to subsequent ischemia and inflammation, and it leads to further tissue destruction, prolonging recovery.

Disruption of the autonomic nervous system after severe SCI, particularly rostral to thoracic level 5, where sympathetic nervous system fibers exit the spinal cord and innervate the immune system, leads to dysregulated local and systemic inflammatory responses, impairment of immune function, and increased infection risk, all of which hinder recovery after SCI. Acute inflammation in the spinal cord exacerbates the primary SCI injury, triggers secondary injury, worsens ischemia and scarring, and inhibits recovery. Chronic SCI results in long-term systemic inflammation, which is clinically exacerbated by a state of chronic immunosuppression

Spinal cord injury and other types of injury are not totally preventable. Prevention and mitigation of the pathophysiologic sequelae of an SCI devastating injury are critical to preserving spinal cord tissue and improving functional outcome after injury. In acute SCI, multimodal real-time monitoring of biomarkers such as perfusion pressure, oxygenation, intrathecal pressure, temperature, and inflammatory markers does not exist. Interventions such as cerebrospinal fluid (CSF) drainage and maintaining mean arterial pressure (MAP) goals have shown great promise. Electrical stimulation has also been reported to influence inflammatory pathways. However, it is currently impossible to optimally titrate these therapies in real-time because there is no way to directly and continuously assess the spinal cord after SCI.

Loss of motor control is perhaps the most obvious sequela of SCI. However, multiple systems, including the functions of cardiovascular and bladder control, are affected after this injury. Urological complications after SCI require lifelong management. SCI also causes profound disruption of the cardiovascular (CV) system, particularly in motor-complete injuries in the cervical and upper thoracic levels. CV dysregulation leads to persistent hypotension, bradycardia, orthostatic hypotension, and episodes of autonomic dysreflexia, which drastically diminish quality of life by affecting overall health and preventing patients from engaging in activities of daily life. Ultimately, the simultaneous restoration of motor, CV, and urologic systems would allow patients with SCI and certain other injuries to fully participate in daily activities.

Accordingly, there is a need for systems and methods for effective monitoring and treatment of spinal cord and other injuries.

SUMMARY

In accordance with an aspect of the present disclosure, an implant is disclosed. The implant includes a cannula. The cannula defines an axial drainage bore and a plurality of radial openings providing a path of fluid communication between an exterior of the cannula and the axial drainage bore to drain fluid. The implant also includes a first sensor positioned at least partially in the cannula. The first sensor is configured to measure a biomarker in the fluid. The implant also includes a second sensor positioned at least partially in the cannula. The second sensor is configured to measure a pressure of the fluid. The implant also includes a third sensor positioned at least partially in the cannula. The third sensor is configured to measure a temperature of the fluid.

A system is also disclosed. The system includes an acute cerebrospinal fluid (CSF) management implant configured to be implanted at least partially into a subarachnoid space in a body during spinal decompression and stabilization surgery. The implant includes a cannula. The cannula defines an axial drainage bore. The cannula also defines a plurality of radial openings providing a path of fluid communication between an exterior of the cannula and the axial drainage bore to drain the CSF in the subarachnoid space to adjust an intrathecal pressure, a perfusion, or both. The cannula also defines a plurality of axial sensor bores positioned radially outward from the axial drainage bore. The implant also includes an evanescent wave spectrophotometer positioned at least partially in the cannula. The spectrophotometer includes a light source configured to transmit light having a wavelength that substantially matches a peak wavelength of an intrathecal optical absorption of lactate. The spectrophotometer also includes a beam splitter, a directional coupler, or both configured to separate the transmitted light from received light. The absorbed light is equal to the transmitted light minus the received light. The spectrophotometer also includes a first fiber optic sensor positioned at least partially in a first of the axial sensor bores. The first fiber optic sensor is configured to measure the absorbed light, which is used to determine a chemical concentration of the CSF without altering the chemical concentration of the CSF. The chemical concentration of the CSF is used to determine the intrathecal optical absorption of lactate. The implant also includes a second fiber optic sensor positioned at least partially in a second of the axial sensor bores. The second fiber optic sensor includes an extrinsic interferometer that is configured to measure a phase shift of the transmitted light due to deflection of a diaphragm located at a tip of the second fiber optic sensor. The phase shift is used to determine the intrathecal pressure. The implant also includes a third fiber optic sensor positioned at least partially in a third of the axial sensor bores. The third fiber optic sensor includes an internal Bragg grating that is configured to measure an intrathecal temperature. The system also includes a controller configured to be positioned outside of the body. The controller is configured to receive the intrathecal optical absorption of lactate, the intrathecal pressure, and the intrathecal temperature. The controller is also configured to control the implant to adjust an amount of the CSF that drains based at least partially upon the intrathecal optical absorption of lactate, the intrathecal pressure, the intrathecal temperature, or a combination thereof.

A method for monitoring and treating an injury is also disclosed. The method includes inserting a needle and a stylet at least partially into a body. The stylet is positioned at least partially within the needle. The method also includes removing the stylet from the needle once the needle is positioned at least partially in the body. The method also includes inserting an implant through the needle and into the body after the stylet is removed. The implant includes a cannula. The cannula defines an axial drainage bore. The cannula also defines a plurality of radial openings providing a path of fluid communication between the axial drainage bore and an exterior of the cannula to drain fluid. The implant also includes a first sensor positioned at least partially in the cannula. The first sensor is configured to measure a biomarker in the fluid. The implant also includes a second sensor positioned at least partially in the cannula. The second sensor is configured to measure a pressure of the fluid. The implant also includes a third sensor positioned at least partially in the cannula. The third sensor is configured to measure a temperature of the fluid.

A method for monitoring and treating an injury is also disclosed. The method includes measuring one or more parameters with one or more sensors. The one or more sensors are positioned at least partially within an implant. The implant is positioned at least partially within a living body. The implant also includes a catheter that is configured to drain a fluid from a portion of the living body. The method also includes controlling the one or more parameters based at least partially upon the one or more measured parameters.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate certain embodiments, and together with the written description, serve to explain certain principles of the methods, devices, kits, systems, and related computer readable media disclosed herein. The description provided herein is better understood when read in conjunction with the accompanying drawings which are included by way of example and not by way of limitation. It will be understood that like reference numerals identify like components throughout the drawings, unless the context indicates otherwise. It will also be understood that some or all of the figures may be schematic representations for purposes of illustration and do not necessarily depict the actual relative sizes or locations of the elements shown.

FIG. 1 illustrates a schematic of a system, according to an embodiment.

FIG. 2 illustrates a wearable device that is a part of the system, according to one embodiment.

FIG. 3 illustrates an implantable device that is a part of the system, according to one embodiment.

FIG. 4 illustrates a control device that is a part of the system, according to one embodiment.

FIG. 5 illustrates a schematic diagram of a system, according to an embodiment.

FIG. 6A illustrates a perspective view of one of the implantable devices: an acute cerebrospinal fluid management implant (ACMI), and FIG. 6B illustrates a cross-sectional view of a portion of the ACMI, according to an embodiment.

FIG. 7 illustrates a perspective view of a cannula that may be used with the ACMI, according to an embodiment.

FIG. 8 illustrates a perspective view of a portion of another cannula that may be used with the ACMI, according to an embodiment.

FIG. 9 illustrates a perspective view of a portion of another cannula that may be used with the ACMI, according to an embodiment.

FIG. 10A illustrates a side view of a sensor in the ACMI, and FIG. 10B illustrates a schematic cross-sectional side view of the sensor in FIG. 10A, according to an embodiment.

FIG. 11 illustrates a side view of another sensor in the ACMI, according to an embodiment.

FIG. 12 illustrates a flowchart of a method for implanting and controlling the ACMI in a body, according to an embodiment.

FIG. 13 illustrates a needle and a stylet (or trocar) being inserted at least partially into the body, according to an embodiment.

FIG. 14A illustrates a first example of a needle, and FIG. 14B illustrate an enlarged portion of the needle, according to an embodiment.

FIG. 15A illustrates a second example of a needle, and FIG. 15B illustrate an enlarged portion of the needle, according to an embodiment.

FIG. 16A illustrates a third example of a needle, and FIG. 16B illustrates a (e.g., lower) portion of the needle, according to an embodiment.

FIG. 17A illustrates a first example of a stylet, and FIG. 17B illustrates an enlarged portion of the stylet, according to an embodiment.

FIG. 18A illustrates a second example of a stylet, and FIG. 18B illustrates an enlarged portion of the stylet, according to an embodiment.

FIG. 19 illustrates the ACMI being inserted through the needle and into the body, according to an embodiment.

FIG. 20 illustrates the ACMI implanted in the body and the needle removed from the body, according to an embodiment.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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 disclosures 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.

As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Thus, for example, a reference to “a method” includes one or more methods, and/or steps of the type described herein and/or which will become apparent to those persons skilled in the art upon reading this disclosure and so forth.

It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. Further, unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains.

The present disclosure relates, in certain aspects, to systems, devices and methods for the monitoring of and treatment of injuries in humans. In some embodiments, the present disclosure relates, in certain aspects, to systems, devices and methods for the monitoring of and treatment of spinal cord injuries in humans, although the system may be used for other types of injuries such as brain injuries, burn injuries, etc.

Embodiments disclosed herein provide a system and corresponding methods that can provide monitoring and stimulation of the spinal cord or area of an injury by utilizing an implantable device implantable near the injury. The implantable device may include a sensor to sense/image the injury and a first condition of the human related to the injury. The implantable device may also include a treatment device for treatment of the injury.

The system may also include a wearable device configured to be worn by the human. The wearable device may be configured to sense a second condition of the human related to the injury.

The system may further include a control device separate from the wearable device and the implantable device. The control device may receive signals from the wearable device and from the implantable device based on the sensed first and second conditions. In response to the signals, the control device may be configured to control the treatment device.

In some embodiments, the system is configured to monitor and treat spinal cord injuries (SCI), although other types of injuries could be monitored and treated. The implantable device may be configured to be implanted near the spinal cord injury or other type of injury to sense conditions of and treat the spinal cord injury or other injury.

As shown in FIG. 1, a system 100 is configured for monitoring and treatment of injuries to a human body. The system may include a control device 102, a wearable device 104 and an implantable device 106. The control device 102 may be configured to control the system 100. The control device 102 is connected to the wearable device 104 and to an implantable device 106. The control device 102 may be connected to the wearable device 104 and to the implantable device 106 by a wired connection, such as by cables, but in certain preferred embodiments the control device 102 may be connected to the wearable device 104 and to the implantable device 106 by a wireless connection, such as Wi-Fi, Bluetooth, etc.

The wearable device 104 may be one wearable device or a plurality of wearable devices. The wearable device 104 is configured to be wearable on or in proximity to the human body. For example, the wearable device 104 may be attached by a strap or other means to a portion of the human body such as to an arm, a leg, a waist, a neck, etc. In alternative embodiments, the wearable device may be configured to be attached in proximity to a particular portion of the human body. For example, the wearable device 104 may be configured to be attached to clothes worn by a person. The wearable device 104 may also be integrated into or attached to another device worn by a person. For example, the wearable device 104 could be configured to attach to a watch, to a belt, to jewelry, etc.

The system 100 may additionally include a software application running on a device such as an Android tablet with an SCI-specific interface for both a physician and a patient that includes an API, allowing peripherals to use the application to change device settings to support closed-loop control of the therapy.

FIG. 2 illustrates further details of the wearable device 104. In certain embodiments, the wearable device may include a sensing device 108 configured to sense conditions of a human related to an injury. The sensing device 108 may be a sensor, imaging device or other type of sensing device configured to sense a condition of the human body related to an injury. For example, the sensing device 108, in some embodiments, may be configured to sense blood pressure, temperature, conditions related to a bladder such as pressure and volume, motion of human limbs such as an arm or a leg, etc.

The sensing device 108 may be any type of sensing device configured to sense a condition of the human body related to the injury. In some embodiments, the sensing device may be an imaging device, an ultrasound device, a temperature sensing device, an electromyography (EMG) sensor with accelerometers, etc.

The wearable device 104 is some embodiments may include a treatment device 112, although other wearable devices 104 may omit the treatment device. The treatment device 112 may be configured to apply a treatment related to the injury. In some embodiments described herein the treatment device may be configured to apply an electrical stimulation or some other type of treatment, as further described herein.

The wearable device 104 may include a communications interface 110 for sending signals to the control device 102 and for receiving signals from the control device 102. The communications interface in some embodiments may be a wireless interface configured to send and receive signals to and from the control device 102. The signals may be indicative of the sensed conditions of the body related to the injury.

The control device 102 is configured to send and receive signals to the communications interface to control the sensing device 108 of the wearable device 104 and/or to control the treatment device 112. For example, the control device can be configured to cause the sensing device 108 to be activated to sense conditions and to cause the treatment device 112 to apply treatment to the human body.

FIG. 3 illustrates the implantable device 106. The system 100 may include one implantable device or a plurality of implantable devices 106. The implantable device 106 is configured to be implanted within the human body. In some embodiments, the implantable device 106 may include a sensing device 116, a treatment device 118 and a communications interface 120.

The sensing device 112 may be configured to sense conditions of or related to an injury to a human. For example, the sensing device 112 may be an imaging device, a sensor or another type of sensing device. In some embodiments the sensing device may be an imaging device such as an ultrasound imaging device or other type of imaging device. In some embodiments, the sensing device 112 may be a sensor configured to sense conditions of a body related to an injury, such as a pressure sensor, a temperature sensor, a biomarker sensor, an EMG sensor, etc.

FIG. 4 illustrates the control device 400 which may be equivalent to the control device 102 of FIG. 1. The control device 400 may be a computerized device such as a desktop or laptop computer, a server computer, etc. The control device 400 includes a processor 402, a memory, storage device, or memory component 404, and a communications interface 408. The memory 404 optionally includes volatile and/or nonvolatile memory including, for example, RAM, ROM, and magnetic or optical disks, among others. The control device 400 may also include a display and a user interface (not shown). In certain aspects, the communications interface allows the control device 400 to send a receive signals to and from the implantable device 106 and the wearable device 104. The control device 400 also includes program product 406 stored in the memory 404.

Exemplary program product or machine readable medium 406 is optionally in the form of microcode, programs, cloud computing format, routines, and/or symbolic languages that provide one or more sets of ordered operations that control the functioning of the hardware and direct its operation. Program product 406, according to an exemplary aspect, also need not reside in its entirety in volatile memory, but can be selectively loaded, as necessary, according to various methodologies.

The term “computer-readable medium” or “machine-readable medium” refers to any medium that participates in providing instructions to a processor for execution. To illustrate, the term “computer-readable medium” or “machine-readable medium” encompasses distribution media, cloud computing formats, intermediate storage media, execution memory of a computer, and any other medium or device capable of storing program product 508 implementing the functionality or processes of various aspects of the present disclosure, for example, for reading by a computer. A “computer-readable medium” or “machine-readable medium” may take many forms, including but not limited to, non-volatile media, volatile media, and transmission media. Non-volatile media includes, for example, optical or magnetic disks. Volatile media includes dynamic memory, such as the main memory of a given system. Transmission media includes coaxial cables, copper wire and fiber optics, including the wires that comprise a bus. Transmission media can also take the form of acoustic or light waves, such as those generated during radio wave and infrared data communications, among others. Exemplary forms of computer-readable media include a floppy disk, a flexible disk, hard disk, magnetic tape, a flash drive, or any other magnetic medium, a CD-ROM, any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, and EPROM, a FLASH-EPROM, any other memory chip or cartridge, a carrier wave, or any other medium from which a computer can read.

In some aspects, program product 406 includes non-transitory computer-executable instructions which, when executed by electronic processor 402 perform at least: monitoring and treatment of injuries in a human by controlling the implantable device 106 and/or the wearable device 104. The systems and methods disclosed herein may include machine learning such that the systems can adapt by learning. For example, the system 100 can monitor how a human reacts to various treatments applied by the implantable device 106 and/or the wearable device 104 and learn how to better apply the treatments to various sensed conditions.

FIG. 5 illustrates a system 500 according to a particular embodiment. The system 500 may be configured for monitoring and treatment of a spinal cord injury of a human, although the system 500 could be used for other types of injuries, such as a brain injury, etc. The system 500 includes a control device 502, a plurality of implantable devices 504 and 506, and a plurality of wearable devices 508, 510 and 512. One or more of the implantable devices 504 and 506 and the plurality of wearable devices 508, 510 and 512 could be omitted from the system 500. The control device 502 may be configured in a same manner as the control device 400.

The wearable device 508 may be a wearable device configured to sense a blood pressure of a human wearing the wearable device. In FIG. 5, the wearable device is shown wearable over an arm of a human, although the wearable device 508 could be positioned in a different location, such as on a torso, a leg, etc. The wearable device 508 may include a sensing device to sense a blood pressure. The wearable device 508 may be configured to generate signals indicative of the sensed conditions, and to send the signals to the control device 102. The wearable device 508 may include means to affix to the body, such as a sticky surface, a strap, etc.

The wearable device 510 may be a wearable device configured to sense a bladder volume and or bladder pressure of a human wearing the wearable device. In FIG. 5, the wearable device is shown. The wearable device 510 may include a sensing device to sense a bladder pressure and/or volume. The wearable device 510 may be configured to generate signals indicative of the sensed conditions, and to send the signals to the control device 102. The wearable device 510 may include means to affix to the body, such as a sticky surface, a strap, etc.

The wearable device 512 may be an EMG wearable device configured to sense/detect motor functions of a human wearing the wearable device. In FIG. 5, the wearable device 512 is shown wearable in a leg area of a human, although the wearable device 512 could be positioned in a different location. The wearable device 512 may include a sensing device or devices to sense a motor functions. The wearable device 512 may be configured to generate signals indicative of the sensed conditions, and to send the signals to the control device 102. The wearable device 512 may include means to affix to the body, such as a sticky surface, a strap, etc.

In some embodiments, a plurality of the wearable devices 512 may be utilized. For example, in some embodiments, a wearable device could be wearable on each arm and each leg, so that the system could monitor motor function of each arm and leg.

In some embodiments, the wearable device may include one or a plurality of accelerometers. In some embodiments, the accelerometers may be configured to generate signals indicative of a limb's motion in real time. The wearable device may be configured to send such signals to the control device 102.

The implantable device 504 may be a multi-function spinal cord implant (MUSIC). The multi-function spinal cord implant 504 may include one or more imaging or sensing devices and one or more treatment devices. In an embodiment, the imaging devices may include an ultrasound imaging array or arrays to generate three-dimensional images of the spinal cord at an injury location and an electrical array or arrays for electrical recording, although other types of imaging or sensing devices could be used. The treatment devices may include an electrical stimulation device or devices for applying electrical stimulation and a focused ultra-sound (FUS) device or devices for applying focused ultra-sound treatment, although other types of treatment devices may be used.

The multi-function spinal cord implant 504 may be a multimodal, conformal, wireless epidural implant device for use in patients with acute or chronic SCI. The multi-function spinal cord implant 504 may be configured to: a) produce three-dimensional, real-time, high-resolution imaging at the injury site to monitor and prevent secondary injury; b) evaluate and assess the reestablishment of autoregulation to optimize acute intervention; (c) measure biomarkers using aptamers; (d) enhance blood flow and potential neural regeneration as a result of acoustic neuromodulation/focused ultrasound (FUS) at the site of injury; (e) actuate release of encapsulated pharmacotherapeutic agents; (f) measure electrical conductivity above and below the site of injury; and (g) stimulate and record neurophysiological data with electrodes. In some embodiments, the multi-function spinal cord implant 504 may conform to the dorsal spinal cord while displacing a volume of only about 50 mm³.

In some embodiments, the multi-function spinal cord implant 504 may be wirelessly powered from an external “relay station” attached outside the body at the implant site. This facilitates higher power levels without bulky battery implants. In some embodiments, the multi-function spinal cord implant 504 may communicates with the relay station via a custom ultra-wide-band networking protocol that may support 200 Mbps uplink and 100 Mbps downlink. The relay station may be an 802.11 device that communicates wirelessly with the control device 102.

In some embodiments, the multi-function spinal cord implant (MUSIC) 504 may be configured to interface with custom-designed encapsulating hydrogel scaffolds that can be stimulated with focused ultrasound (FUS) to deliver pharmacotherapeutic agents. FUS may also be used to enhance blood flow at the site of the injury. In some embodiments, the multi-function spinal cord implant 504 may be a biocompatible, permanently implantable wireless device.

The implantable device 506 may be a cerebrospinal fluid (CSF) management implant, also referred to as an acute CSF management implant (ACMI), 506, although other type of implantable devices could be used. In some embodiments, the ACMI 506 may be a smart spinal fluid drainage catheter. In some embodiments, the ACMI 506 may be configured to drain CSF while simultaneously using fiber optics technology to sense biomarkers such as intrathecal pressure, oxygenation, lactate, and temperature.

In some embodiments, ACMI 506 may include one or a plurality of sensors. The sensors may be configured to sense/detect temperature, pressure and biomarkers. In some embodiments, the ACMI 506 may be configured to include optical sensors for measuring intrathecal pressure and temperature. In some embodiments, ACMI 506 may include sensors such as a fiber-optic, spectroscopy system that monitors spinal cord oxygenation by providing nearly continuous CSF concentration measurements of oxygenation indicators, such as lactate.

In some embodiments, ACMI 506 may include a drainage catheter to remove spinal fluid to adjust intraspinal pressure. In some embodiments, ACMI 506 measuring and managing CSF pressure throughout the acute phase of neurological injury.

Another implantable device may be utilized with the system 500, an epidural spinal stimulator (ESS) device. In some embodiments, the ESS device may be a biocompatible epidural implant. The ESS implantable device may be placed at the lumbosacral level (L1-S2), in the post-acute period of injury.

In some embodiments, the ESS device may be configured with electrodes configured to apply electrical stimulation of the spinal cord, particularly of the dorsal lumbosacral spinal cord. Dorsal epidural electrical stimulation does not induce movement by directly activating motor pools. Instead, it enables motor function by (1) stimulating medium- and large-diameter afferent fibers in lumbar and upper sacral posterior roots that transmit proprioceptive information from muscle spindle primary endings in the legs to the spinal cord and trans-synaptically engaging interneurons that integrate the proprioceptive inputs and central pattern generator networks. Epidural electrical stimulation modulates spinal circuits into a physiological state that allows for task-specific sensory input derived from movements to serve as a source of motor control.

In certain embodiments, motor outputs of the stimulation provided by the ESS device can be monitored and characterized by an accelerometer as well as by EMG potentials in target muscles. The EMG wearable device 512 may be used in conjunction with the ESS device in a manner that when the ESS device applies electrical stimulation, the EMG device monitors and generates signals indicative of the movement of the limbs of a human.

In some embodiments, properties of the signals generated by the EMG wearable device, such as latencies and peak-to-peak amplitudes, will be fed back to the epidural stimulation console to provide real-time information on locomotor output that are used to dynamically modulate and optimize stimulation parameters.

The ESS device may be configured to provide extremely fine temporal resolution (i.e., time resolution of 10 μs), increased independent rate options for programs providing therapy simultaneously, and independent amplitude control on each active electrode. The control device 102 may be configured with an ESS application programming interface (API), may be configured to wirelessly adjust the stimulation provided by the ESS device, at a rate of, for example, up to six times per second. In conjunction with intent information decoded from the individual's neural activity (the MUSIC device), posture and muscle-firing information (wearable EMG and accelerometer), bladder and CV parameters (wearable sensors), and machine learning algorithms for closed-loop neuromodulation, the ESS device is configured to be used to restore complex motor, bladder, and CV control.

In some embodiments, the ESS device is configured to be used to along with the other elements of the system 100 to restore complex motor, bladder, and CV control to an individual with a SCI. For example, when electrical stimulation is provided by the ESS device, the control device can receive signals from the sensor devices to monitor motor, bladder and CV control in response thereto.

In some embodiments, the ESS device can using a MICS band/Bluetooth relay, with USB or Bluetooth connection to the control device 102. MICS band communication will allow the control device to be several feet away from the patient while still providing therapy in a closed-loop manner through distance telemetry.

In some embodiments, the ESS device is configured to be implanted subcutaneously in the abdomen, flank, or upper buttock area, but could be implanted elsewhere. consists of a hermetic titanium enclosure housing stimulation and telemetry electronics with a battery. In some embodiments, the ESS device is configured to be used to stimulate the lumbar area of the spinal cord to provide SCI therapy.

In some embodiments, the system 100, 500 may be used to treat and monitor an individual with a SCI. For example, an individual with a SCI, such as a severe thoracic SCI, can have the ACMI device 506 implanted at subarachnoid space, and the MUSIC device 504 implanted epidurally at the site of the injury.

The ACMI device 506 is used for selectively draining CSF based on sensed feedback from its sensors. For example, the sensors the ACMI device may be configured to sense intrathecal pressure, oxygenation, lactate, and temperature, and feed signals indicative of the sensed conditions to the control device 102. The control device can control the ACMI device 506 to then selectively draining CSF based on analyzing the signals.

The MUSIC device 504 utilizes its ultrasound and/or electrical imaging sensors to generate three-dimensional, real-time, high-resolution imaging at the injury site to monitor and prevent secondary injury, and to selectively provide acoustic neuromodulation and/or focused ultrasound (FUS) at the site of injury. The MUSIC device 504 may be configured to generate signals/images based on conditions sensed by its sensors, and to send those signals to the control device 102. The control device 102 may be configures to selectively provide acoustic neuromodulation and/or focused ultrasound based on analyzing the received signals.

In a post-acute period, the ESS device may be implanted, and the wearable devices 104 may be worn and utilized with the system 100, 500. The ESS device may be configured to selectively apply electrical stimulation of the dorsal lumbosacral spinal cord based on sensed conditions from any of the wearable devices 104 or the implantable devices 106.

The system 100, 500 includes software programs (algorithms) as program product 406 that include a machine-learning modelling framework. All sensed data may be loaded to a persistent datastore. The data in the datastore is used with a real-time implementation of a multimodal time-series classification network built on efficient implementations of deep convolutional neural networks for processing multi-scale spatiotemporal representations. The networks are trained to predict optimal interventions (e.g., stimulation with electrodes, ultrasound, and drug delivery) based on simultaneous analysis of the MUSIC implant's electrode array, ultrasound measurements, and ACMI biomarker inputs, for example. Regression models based on deep features extracted from ultrasound using convolutional neural networks, can be used to estimate bladder state and blood pressure. As the amount of chronic data in the datastore increases and more functionality is demanded from the system, the algorithms are trained and deployed to predict improved stimulation patterns from multimodal inputs.

The present disclosure also provides various systems and computer program products or machine readable media. In some aspects, for example, the methods described herein are optionally performed or facilitated at least in part using systems, distributed computing hardware and applications (e.g., cloud computing services), electronic communication networks, communication interfaces, computer program products, machine readable media, electronic storage media, software (e.g., machine-executable code or logic instructions) and/or the like.

As understood by those of ordinary skill in the art, memory 404 of the control device 400 optionally includes volatile and/or nonvolatile memory including, for example, RAM, ROM, and magnetic or optical disks, among others. It is also understood by those of ordinary skill in the art that although illustrated as a control device, the illustrated configuration of control device 400 is given only by way of example and that other types of servers or computers configured according to various other methodologies or architectures can also be used. As also understood by those of ordinary skill in the art, the control device 400, for example, can be a laptop, desktop, tablet, personal digital assistant (PDA), cell phone, server, or other types of computers.

As further understood by those of ordinary skill in the art, exemplary program product or machine readable medium 406 is optionally in the form of microcode, programs, cloud computing format, routines, and/or symbolic languages that provide one or more sets of ordered operations that control the functioning of the hardware and direct its operation. Program product 406, according to an exemplary aspect, also need not reside in its entirety in volatile memory, but can be selectively loaded, as necessary, according to various methodologies as known and understood by those of ordinary skill in the art.

As further understood by those of ordinary skill in the art, the term “computer-readable medium” or “machine-readable medium” refers to any medium that participates in providing instructions to a processor for execution. To illustrate, the term “computer-readable medium” or “machine-readable medium” encompasses distribution media, cloud computing formats, intermediate storage media, execution memory of a computer, and any other medium or device capable of storing program product 508 implementing the functionality or processes of various aspects of the present disclosure, for example, for reading by a computer. A “computer-readable medium” or “machine-readable medium” may take many forms, including but not limited to, non-volatile media, volatile media, and transmission media. Non-volatile media includes, for example, optical or magnetic disks. Volatile media includes dynamic memory, such as the main memory of a given system. Transmission media includes coaxial cables, copper wire and fiber optics, including the wires that comprise a bus. Transmission media can also take the form of acoustic or light waves, such as those generated during radio wave and infrared data communications, among others. Exemplary forms of computer-readable media include a floppy disk, a flexible disk, hard disk, magnetic tape, a flash drive, or any other magnetic medium, a CD-ROM, any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, and EPROM, a FLASH-EPROM, any other memory chip or cartridge, a carrier wave, or any other medium from which a computer can read.

Program product 406 is optionally copied from the computer-readable medium to a hard disk or a similar intermediate storage medium. When program product 406, or portions thereof, are to be run, it is optionally loaded from their distribution medium, their intermediate storage medium, or the like into the execution memory of one or more computers, configuring the computer(s) to act in accordance with the functionality or method of various aspects. All such operations are well known to those of ordinary skill in the art of, for example, computer systems.

To further illustrate, in certain aspects, this application provides systems that include one or more processors, and one or more memory components in communication with the processor. The memory component typically includes one or more instructions that, when executed, cause the processor to provide information that causes at least one result, data, and/or the like to be displayed or otherwise indicated (e.g., via a result indicator of control device 400) and/or receive information from other system components and/or from a system user (e.g., via communication interface 408 or the like).

In some aspects, program product 406 includes non-transitory computer-executable instructions which, when executed by electronic processor 402 perform at least execution of algorithms contained in the computer program product 406 configured to perform the functionality described herein.

Acute Cerebrospinal Fluid Management Implant (ACMI)

As mentioned above, the HEPIUS may include six devices. Three of the devices may be remote wireless wearable devices, and three of the devices may be implantable devices. One of the implantable devices may be an acute cerebrospinal fluid management implant (ACMI). The ACMI may be configured to be implanted at least partially into a subarachnoid space in a spine in a body. The ACMI may serve as a smart multi-liminal spinal fluid drainage catheter. The ACMI may be capable of simultaneously draining cerebrospinal fluid (CSF) and sensing parameters such as intrathecal pressure, temperature, lactate, and oxygenation. Modulating the CSF in the subarachnoid space may adjust intraspinal pressure, which may enhance spinal cord blood flow. In one embodiment, a cardiac-gated oscillatory balloon may be implanted at least partially within the ACMI to enhance spinal cord perfusion at the site of the injury and the penumbral zone. The ACMI may be biocompatible, flexible, and small enough in diameter to be incorporated with minimal flow disruption into a spinal drainage catheter.

ACMI Cannula

FIG. 6A illustrates a perspective view of the ACMI 600, according to an embodiment. The ACMI 600 may be the same as or different from the ACMI 506 described above. The ACMI 600 may include a cannula 610. The cannula 610 may be or include a thin tube that is configured to be inserted into a vein or body cavity to administer medicine, drain off fluid, or insert a surgical instrument. In one embodiment, the cannula 610 may have a cross-sectional width (e.g., diameter) from about 0.5 mm to about 3 mm, about 1.5 mm to about 2.5 mm, or about 1.75 mm to about 2.25 mm. The cannula 610 may define drainage bore 612. The cannula 610 may include a plurality of openings (also referred to as a fenestrated tip) 620 that provide a path of fluid communication between the exterior of the cannula 610 and the interior of the cannula 610 (e.g., the drainage bore 612). The openings 620 may extend in a substantially radial direction with respect to a central longitudinal axis 611 through the cannula 610. The openings 620 may be located proximate to an end portion of the cannula 610. The fluid may flow into the bore 612 via the openings 620. In one example, the openings 620 may serve to drain CSF from the spine (e.g., from the subarachnoid space).

FIG. 6B illustrates a cross-sectional view of a portion of the ACMI 600 in FIG. 6A, according to an embodiment. In addition to the drainage bore 612, the ACMI 600 may also define one or more sensor bores (three are shown: 614, 616, 618). The sensor bores 614, 616, 618 may be positioned radially-outward from the drainage bore 612. The sensor bores 614, 616, 618 may be circumferentially offset from one another around the central longitudinal axis 611 and/or the drainage bore 612. The sensor bores 614, 616, 618 may each have a smaller diameter than the drainage bore 612. For example, one or more of the sensor bores 614, 616, 618 may have a diameter from about 0.2 mm to about 0.6 mm, about 0.3 mm to about 0.5 mm, or about 0.4 mm, and the drainage bore 612 may have a diameter from about 0.5 mm to about 1 mm, about 0.6 mm to about 0.8 mm, or about 0.7 mm.

As described in greater detail below, the ACMI 600 may also include one or more sensors (three are shown: 630, 640, 650), which may be positioned at least partially in the sensor bores 614, 616, 618. One or more of the sensors 630, 640, 650 may be or include fiber optic sensors.

FIG. 7 illustrates a perspective view of another cannula 710 that may be used with the ACMI 600, according to an embodiment. The cannula 710 may include the drainage bore 712 and the sensor bores 714, 716, 718. The sensor bores 714, 716, 718 may be substantially equally spaced around the central longitudinal axis 711 (e.g., 120° apart from one another). The cannula 710 may also include the openings 720. As may be seen, the openings 720 may extend in one or more longitudinal rows. The rows may be circumferentially offset from one another.

FIG. 8 illustrates a perspective view of a portion of another cannula 810 that may be used with the ACMI 600, according to an embodiment. The cannula 810 may include the drainage bore 812 and the sensor bores 814, 816, 818. The sensor bores 814, 816, 818 may not be substantially equally spaced around the central longitudinal axis 811. Rather, the sensor bores 814, 816, 818 may be spaced apart from another from about 5° to about 60°, about 5° to about 40°, or about 5° to about 20°.

FIG. 9 illustrates a perspective view of a portion of another cannula 910 that may be used with the ACMI 600, according to an embodiment. The cannula 910 may be similar to the cannula 810, except that the cannula 910 may include a substantially flat shoulder 920 proximate to an end thereof. The presence of the shoulder 920 may reduce the length of the sensor bores 914, 916, 918; however, it may not reduce the length of the drainage bore 912. As a result, the drainage bore 912 may extend farther and/or be longer than the sensor bores 914, 916, 918. The shoulder 920 may serve as a reference for radial and/or angular location of the catheter placement. It may also serve to prevent or reduce clogging of the pores, by providing a sharper edge, than all curved around. In other words, the device is not limited to circular/round in shape.

ACMI Sensors

Referring again to FIG. 6B, the first sensor 630 may be located at least partially in the first sensor bore 614, 714, 814, 914. The first sensor 630 may be or include a biomarker sensor that is configured to sense one or more biomarkers (e.g., in the fluid in the subarachnoid space in the spine in the body). The biomarker(s) may be or include lactate, glutamate, cytochrome C, L-citrulline, S100b, IL-6, GFAP, bilirubin, ascorbate, or a combination thereof. As described below, the biomarker(s) may be used to determine a concentration of oxygenation in the CSF.

In one embodiment, the first sensor 630 may be or include an evanescent wave spectrophotometer. Thus, the first sensor 630 may include a light source 632 that is configured to transmit light. The light may have a wavelength that substantially matches (e.g., +/−20 nm) a peak wavelength of an intrathecal optical absorption of the biomarker (e.g., lactate). The first sensor 630 may also include a beam splitter 634 that is configured to separate the transmitted light from received light. In one embodiment, a directional coupler may be used instead of, or in addition to, the beam splitter. Absorbed light is equal to the transmitted light minus the received light. The first sensor 630 may also include a first fiber optic sensor 636 that is configured to measure the absorbed light. The absorbed light may then be used to determine a chemical concentration of the CSF without altering the chemical concentration of the CSF. The chemical concentration of the CSF may then be used to determine the intrathecal optical absorption of the biomarker (e.g., lactate). As mentioned above, the intrathecal optical absorption of the biomarker may then be used to determine the concentration of oxygenation in the CSF.

The second sensor 640 may be located at least partially in the second sensor bore 616, 716, 816, 916. The second sensor 640 may be or include a pressure sensor that is configured to measure a pressure of the fluid (e.g., in the subarachnoid space in the spine in the body). For example, the second sensor 640 may be or include an extrinsic interferometer. FIG. 10A illustrates a side view of the second sensor 640 in the ACMI 600, and FIG. 10B illustrates a schematic cross-sectional side view of the second sensor 640 in the ACMI 600, according to an embodiment. The second sensor 640 may be or include a drum-like structure 642 and a flexible membrane (e.g., a diaphragm) 644 that define a cavity (e.g., a Fabry-Perot cavity) 646 therebetween. The second sensor 640 may also include a second fiber optic sensor 648 into which the light is reflected back to the signal conditioner. The second sensor 640 may be configured to measure a phase shift of the transmitted light (e.g., light transmitted from the first sensor 630 and/or the second sensor 640) due to deflection of the diaphragm 644 located at a tip of the second sensor 640. The phase shift may then be used to determine the intrathecal pressure of the fluid in the subarachnoid space in the spine in the body.

The third sensor 650 may be located at least partially in the third sensor bore 618, 718, 818, 918. The third sensor 650 may be or include a temperature sensor that is configured to measure a temperature of the fluid (e.g., in the subarachnoid space in the spine in the body). FIG. 11 illustrates a side view of the third sensor 650 in the ACMI 600, according to an embodiment. The third sensor 650 may be or include a third fiber optic sensor. For example, the third sensor 650 may be or include an internal Bragg grating that is configured to measure an intrathecal temperature of the fluid in the subarachnoid space in the spine in the body.

ACMI Controller

Referring again to FIG. 6A, while the ACMI 600 is implanted in the body, the ACMI 600 (e.g., the sensors 630, 640, 650) may be configured to communicate with a control device (also referred to as a computing system) 660 that is located outside of the body. The control device 660 may be or include one or more of the control devices (e.g., 102, 400, and/or 502) described above. The communication may be wirelessly or via one or more wires. This is discussed in greater detail below.

ACMI Method

FIG. 12 illustrates a flowchart of a method 1200 for implanting and controlling the ACMI 600 in a body, according to an embodiment. The method 1200 may be performed in response to an injury (e.g., a spinal cord injury). More particularly, the method 1200 may be directed to implanting the ACMI 600 at least partially into a subarachnoid space in the body during spinal decompression and stabilization surgery, and controlling the ACMI 600 while it is in the body. An illustrative order of the method 1200 is provided below; however, one or more steps of the method 1200 may be performed in a different order, combined, split into sub-steps, repeated, or omitted.

The method 1200 may include inserting a needle and a stylet at least partially into a body, as at 1202. FIG. 13 illustrates the needle 1310 and the stylet (or trocar) 1320 being inserted at least partially into the body 1300, according to an embodiment. In one example, the needle 1310 and the stylet 1320 may be inserted during a lumbar puncture at least partially into the subarachnoid space 1304 in the spine 1302 during spinal decompression and stabilization surgery. The needle 1310 may include an axial bore, and the stylet 1320 may be or include a wire or piece of plastic run through the needle 1310 in order to stiffen it or to clear it.

FIG. 14A illustrates a first example of a needle 1410, and FIG. 14B illustrates an enlarged portion of the needle 1410, according to an embodiment. As mentioned above, the needle 1410 may include a cannula 1420 that has an axial bore 1430 extending therethrough. The cannula 1420 may also define a slot 1440 that provides a path of fluid communication from the axial bore 1430 radially-outward to an exterior of the cannula 1420. The slot 1440 may extend at least a portion of the length of the cannula 1420. In the example shown, the slot 1440 extends the full length of the cannula 1420. A first (insertion) end 1422 of the cannula 1420 may be oriented at an angle with respect to a central longitudinal axis 1421 through the cannula 1420. For example, the first end 1422 may be substantially planar and oriented at an angle from about 20° to about 70°, about 30° to about 60°, or about 40° to about 50° with respect to the central longitudinal axis 1421.

FIG. 15A illustrates a second example of a needle 1510, and FIG. 15B illustrates an enlarged portion of the needle 1510, according to an embodiment. The needle 1510 may be referred to as a Tuohy needle. The needle 1510 may include a cannula 1520 that has an axial bore 1530 extending therethrough. A first (insertion) end portion 1522 of the cannula 1520 may be oriented at an angle similar to the angle in FIGS. 14A and 14B. A second end portion 1524 of the cannula 1520 may have a larger cross-sectional width diameter) than the first end portion 1522. In one example, the diameter of the first end portion 1522 may be from about 3.35 mm to about 3.45 mm, and the diameter of the second end portion 1524 may be from about 3.45 mm to about 3.55 mm.

In addition, the second end portion 1524 may define an axial slot 1540 that provides a path of fluid communication from the axial bore 1530 radially-outward to an exterior of the cannula 1520. The slot 1540 may extend at least a portion of the length of the cannula 1520. However, the slot 1540 may not extend the full length. Rather, the slot 1540 may extend from about 2% to about 20% or about 5% to about 10% of the length of the cannula 1520. In the embodiment shown, the slot 1540 may be present in the second end portion 1524 of the cannula 1520 (e.g., with the larger diameter). A first portion 1542 of the slot 1540 may have a substantially constant width, and a second portion 1544 of the slot 1540 may have a decreasing width that leads to an end 1546 of the slot 1540. Thus, the second portion 1544 of the slot 1540 may be oriented at an angle 1548 that may be from about 20° to about 50°, about 25° to about 45°, or about 30° to about 40°. The second portion 1544 and/or the end 1546 of the slot 1540 may be axially proximate to (e.g., at least partially overlapping with) the transition from the larger diameter portion of the cannula 1520 to the smaller diameter portion of the cannula 1520.

Due to the ACMI 600 having one or more sensors 630, 640, 650, a conventional needle that slides over the ACMI 600 may not be used. In one embodiment, the needle 1510 may split into two separate cannulas after the ACMI 600 has been implanted (e.g., within the thecal sac) and the needle 1510 has been withdrawn from the soft tissue surrounding the lumbar spine.

FIG. 16A illustrates a third example of a needle 1610, and FIG. 16B illustrates a (e.g., lower) portion of the needle 1610, according to an embodiment. The needle 1610 may include a cannula 1620 that has an axial bore 1630 extending therethrough. The cannula 1620 may include one or more portions (two are shown: 1640A, 1640B). The portions 1640A, 1640B may be circumferentially offset from one another around a central longitudinal axis 1621 of the cannula 1620. The portions 1640A, 1640B may be configured to be coupled together. In the example shown, the first (e.g., lower) portion 1640A may include one or more ribs (two are shown: 1642A) that extend at least partially radially inward therefrom. Each rib 1642A may define an axial slot 1644A. The second upper) portion 1640B may include one or more protrusions (two are shown: 1644B). The protrusions 1644B may be configured to be positioned at least partially within the slots 1644A to couple the 1640A, 1640B of the cannula 1620 together. This design may allow the needle 1610 to be split into two or more portions after the ACME 600 has been implanted.

FIG. 17A illustrates a first example of a stylet 1720, and FIG. 17B illustrates an enlarged portion of the stylet 1720, according to an embodiment. The stylet 1720 may be or include a substantially cylindrical rod having a first (e.g., insertion) end 1722 and a second end 1724. The first end 1722 may be oriented at an angle that is similar (e.g., +1-10°) to the first (e.g., insertion) end of the needle 1310, 1410, 1510, 1610 into which it is inserted. The second end 1724 may be substantially perpendicular to a central longitudinal axis 1721 through the stylet 1720.

FIG. 18A illustrates a second example of a stylet 1820, and FIG. 18B illustrates an enlarged portion of the stylet 1820, according to an embodiment. Similar to the stylet 1720 described above, the stylet 1820 may include a substantially cylindrical rod having a first (e.g., insertion) end 1822 and a second end 1824. The stylet 1820 may also include a protrusion 1826 that extends radially outward from the rod. The protrusion 1826 may extend at least a portion of the length of the rod. In the example shown, the protrusion 1826 extends substantially full length of the rod (e.g., greater than 90% or 95% of the length). In one embodiment, the protrusion 1826 may be configured to be positioned at least partially within the slot 1440 in FIGS. 14A and 14B. This may serve to provide alignment and/or stability of the stylet 1820 within the cannula.

Referring back to the method 1200 in FIG. 12, once the needle 1310, 1410, 1510, 1610 and the stylet 1320, 1720, 1820 are inserted at least partially into the body 1300, the method 1200 may also include removing the stylet 1320, 1720, 1820 from the needle 1310, 1410, 1510, 1610, as at 1204. The method 1200 may also include inserting the ACMI 600 through the needle 1310, 1410, 1510, 1610 and into the body 1300, as at 1206. FIG. 19 illustrates the ACMI 600 being inserted through the needle 1310, 1410, 1510, 1610 and into the body 1300, according to an embodiment. This may implant the ACMI 600 in the body 1300. In one example, the ACMI 600 may be inserted through the needle 1310, 1410, 1510, 1610 and at least partially into the subarachnoid space 1304 in the spine 1302 during the spinal decompression and stabilization surgery.

The method 1200 may also include removing the needle 1310, 1010, 1110, 1210 from the body 1300, as at 1208. FIG. 20 illustrates the ACMI 600 implanted in the body 1300 and the needle 1310, 1410, 1510, 1610 removed from the body 1300, according to an embodiment. The needle 1310, 1410, 1510, 1610 may be removed from the body 1300 after the ACMI 600 is inserted (i.e., implanted) in the body 1300 (e.g., in the subarachnoid space 1304 in the spine 1302 during the spinal decompression and stabilization surgery).

The method 1200 may also include receiving measured parameters from the ACMI 600, as at 1210. The parameters may be measured while the ACMI 600 is implanted. The measured parameters may be or include biomarker data, pressure data, temperature data, or a combination thereof. The biomarker data may be measured by the biomarker sensor 630 and received by the control device 660. In one example, the biomarker data may be or include intrathecal optical absorption of the biomarker (e.g., lactate) in the CSF. The spinal cord oxygenation may be determined based at least partially upon the biomarker (e.g., lactate). The pressure data may be measured by the pressure sensor 640 and received by the control device 660. In one example, the pressure data may be or include the intrathecal pressure of the CSF. The temperature data may be measured by the temperature sensor 650 and received by the control device 660. In one example, the temperature data may be or include the intrathecal temperature of the CSF.

The method 1200 may also include modifying the parameters, as at 1212. In a first example, one or more medications given to the patient may be modified based at least partially upon the biomarker data, the oxygenation level, or a combination thereof. The medication(s) may also or instead be modified based at least partially upon the pressure and/or temperature. The modification may be to the amount of an existing medication, and/or the modification may include switching medications. Modifying the medication may affect the biomarker data and/or the oxygenation level.

In a second example, an amount and/or rate of drainage (e.g., of the CSF) through the drainage bore 612 and/or the openings 620 may be modified. The modification may be based at least partially upon the pressure data. The modification may also or instead be based at least partially upon the biomarker data and/or the temperature data. The amount and/or rate may be modified by actuating a (e.g., pneumatic) valve. In one embodiment, the valve 670 may be positioned within the body 1300. More particularly, the valve 670 may be at least partially within the subarachnoid space 1304 in the spine 1302. For example, the valve 670 may be positioned at least partially within the AMCI 600, as shown in FIG. 6A. In another embodiment, the valve 1370 may be positioned outside of the body 1300 (but in fluid communication with the axial drainage bore 612), as shown in FIG. 20. Modifying the drainage may affect the pressure data.

In a third example, a temperature (e.g., of the CSF) may be modified. The modification may be based at least partially upon the temperature data. The modification may also or instead be based at least partially upon the biomarker data and/or the pressure data. The temperature may be modified using an internal device. The internal device may be positioned at least partially within the body 1300, at least partially within the subarachnoid space 1304 in the spine 1302, or at least partially within the ACMI 600. The internal device may be or include a heating coil or a tube through which a cooling fluid may be pumped. Alternatively, the temperature may be modified using an external device that is positioned outside of the body 1300. The external device may include ice, a fluid that is cooler than body temperature (e.g., 98.6° F.), a heater, or the like.

As an example, one or more of the sensors 630, 640, 650 may determine that one or more of the parameters is/are above or below a predetermined threshold. This may then be transmitted to the controller 660. Alternatively, the sensors 630, 640, 650 may transmit the measured parameters to the controller 660, which may determine that the measured parameter(s) is/are above or below the threshold(s). The controller 660 of the ACMI 600 may also transmit this data to the HEPIUS controller 102. The controller(s) 102, 660 may then use a machine-learning algorithm to automatically modify the parameters as described in the examples above. Alternatively, the controller 102, 660 may display to a user (or instruct the user) to modify the parameters, and the user can manually modify the parameters. In other words, the ACMI 600 may measure not only temperature and pressure, but also oxygenation (i.e., tissue health) and then automatically (or instruct the user to) modify the medications, drainage, and/or temperature.

The method 1200 may also include determining when a phase of the injury has ended, as at 1214. In one example, this may include determining when an acute phase of a spinal cord injury has ended and/or neurovascular autoregulation (NVAR) has been restored. The determination may be made by the control device 660. The determination may be based at least partially upon the biomarker data, pressure data, temperature data, or a combination thereof.

The method 1200 may also include determining that the ACMI 600 is ready to be removed from the body 900, as at 1216. The determination may be made by the control device 660. The determination may be based at least partially upon the phase of the injury ending.

Although the present disclosure has been described in connection with preferred embodiments thereof, it will be appreciated by those skilled in the art that additions, deletions, modifications, and substitutions not specifically described may be made without departing from the spirit and scope of the disclosure as defined in the appended claims.

ACUTE CEREBROSPINAL FLUID MANAGEMENT IMPLANT

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