Spinal and neurosurgical devices

Abstract

In some embodiments, apparatus and related methods relate to a skeletal body adjustment device (SBAD) with telescopically connected bodies. For example, the SBAD may include control members configured to induce relative translation between the bodies. In some embodiments, apparatus and related methods relate to a body cavity conforming shunt. As an illustrative example, the shunt may, for example, include selectively deployable contact members. The contact members may, by way of example and not limitation, be configured as anchors, sensors, and / or therapy delivery devices. In some embodiments, apparatus and related methods relate to a multi-layer bladder (MLB) selectively deployable in a body cavity. The MLB may, for example, include sensing and / or delivery components. The MLB may, for example, include control member(s) and / or pressure control(s) configured to control shape, size, and / or pressure of the MLB. In some embodiments, apparatus and related methods relate to a dynamically controlled cerebrospinal fluid (CSF) shunt system.

Description

NEUROSURGICAL DEVICES AND METHODSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 590,313, titled “Neurosurgical Devices and Methods,” filed by Samuel Robert Browd, et al., on Oct. 13, 2023.

[0002] The subject matter of this application may have common inventorship with and / or may be related to the subject matter of• U.S. Application Serial No. 18 / 313,249, titled “Dynamically Controlled Cerebrospinal Fluid Shunt,” filed by Samuel Robert Browd, et al., on May 5, 2023;• U.S. Application Serial No. 63 / 365,407, titled "Distributed Sensing and Control of Cerebrospinal Fluid," filed by Samuel Robert Browd, et al., on May 26, 2022;• U.S. Application Serial No. 63 / 477,158, titled "Central Nervous System Monitoring and Intervention," filed by Samuel Robert Browd, et al., on December 23, 2022;• U.S. Application Serial No. 63 / 477,162, titled "Cerebrospinal Fluid Polarization," filed by Samuel Robert Browd, et al., on December 23, 2022;• U.S. Application Serial No. 63 / 488,412, titled "Dynamic Shunt Systems," filed by Samuel Robert Browd, et al., on March 3, 2023;• U.S. Application Serial No. 63 / 364,253, titled "SHUNT TECHNOLOGY AND THE POTENTIAL FOR A SMART SHUNT," filed by Samuel Robert Browd on May 5, 2022; and• U.S. Application Serial No. 63 / 590,191, titled “Dynamic Guided Physician-Patient Interaction Engine,” filed by Samuel Robert Browd, et al., on October 13, 2023.

[0003] This application incorporates herein by reference the entire contents of the foregoing applications and of all applications for which said application(s) claim priority and / or benefit.TECHNICAL FIELD

[0004] Various embodiments relate generally to medical devices and / or methods.BACKGROUND

[0005] The brain's ventricular system and / or cerebrospinal fluid (CSF) may play crucial roles in maintaining the overall health of the central nervous system. Various diseases and disorders can affect these systems, leading to significant neurological complications. Hydrocephalus may, for example, be characterized by an abnormal accumulation of cerebrospinal fluid within the brain's ventricles. This excess fluid can cause increased intracranial pressure, leading to symptoms suchas headaches, vomiting, blurred vision, and cognitive impairments. Treatment often involves the surgical implantation of a shunt to divert the fluid to another part of the body.

[0006] Chiari malformations occur when brain tissue extends into the spinal canal, often affecting the flow of cerebrospinal fluid. This can lead to symptoms like headaches, neck pain, balance problems, and muscle weakness. Treatment may involve surgical decompression to create more space for the brain tissue. Meningitis is an inflammation of the protective membranes covering the brain and spinal cord, usually due to infection. This condition can disrupt the normal flow and composition of cerebrospinal fluid. Symptoms include severe headache, fever, neck stiffness, and sensitivity to light. Treatment typically involves antibiotics or antiviral medication. Normal Pressure Hydrocephalus is a form of hydrocephalus that typically affects older adults. It is characterized by enlarged brain ventricles with normal CSF pressure. Symptoms include walking difficulties, urinary incontinence, and cognitive decline. Treatment often includes the insertion of a shunt to relieve symptoms.

[0007] Pseudotumor Cerebri, also known as idiopathic intracranial hypertension, is characterized by increased intracranial pressure without an apparent cause. Symptoms include severe headaches, vision problems, and ringing in the ears. Treatment may involve medications to reduce CSF production or surgical procedures to relieve pressure. A subarachnoid hemorrhage may involve bleeding into the subarachnoid space, where cerebrospinal fluid circulates. This condition often results from a ruptured aneurysm and can lead to sudden, severe headaches, nausea, and loss of consciousness. Immediate medical intervention is crucial, often requiring surgical repair of the aneurysm and management of CSF pressure. Diseases and disorders affecting the brain's ventricles and cerebrospinal fluid can have profound effects on neurological function. Early diagnosis and appropriate treatment are essential to manage these conditions effectively and improve patient outcomes.The vertebral column, commonly known as the spine, plays a crucial role in supporting the body’s structure and protecting the spinal cord. Diseases and disorders affecting the vertebral column can lead to severe pain, disability, and neurological complications. One prevalent condition is intervertebral disc degeneration, which occurs when the discs that cushion the vertebrae deteriorate over time, leading to back pain, stiffness, and reduced mobility. Scoliosis, characterized by an abnormal lateral curvature of the spine, can cause uneven shoulders, waist, and hips, and in severe cases, can impair lung and heart function. Another common disorder is spinal stenosis, where the spinal canal narrows, compressing the spinal cord and nerves, resulting in pain, numbness, and muscle weakness.Other notable vertebral column disorders include herniated discs and vertebral fractures. A herniated disc, also known as a slipped or ruptured disc, occurs when the soft inner core of a spinaldisc leaks out through a tear in the outer layer, pressing on nearby nerves and causing pain, tingling, and weakness in the affected area. Vertebral fractures, often due to osteoporosis or trauma, can lead to acute back pain and long-term spinal deformity. Additionally, conditions like ankylosing spondylitis, an inflammatory disease that can cause some of the small bones in the spine to fuse, restrict mobility and result in a stooped posture. Prompt diagnosis and appropriate treatment are essential to managing these conditions and improving patient outcomes.SUMMARY

[0008] In some embodiments, apparatus and related methods relate to a skeletal body adjustment device (SB AD) with telescopically connected bodies. For example, the SB AD may include control members configured to induce relative translation between the bodies. In some embodiments, apparatus and related methods relate to a body cavity conforming shunt. As an illustrative example, the shunt may, for example, include selectively deployable contact members. The contact members may, by way of example and not limitation, be configured as anchors, sensors, and / or therapy delivery devices. In some embodiments, apparatus and related methods relate to a multi-layer bladder (MLB) selectively deployable in a body cavity. The MLB may, for example, include sensing and / or delivery components. The MLB may, for example, include control member(s) and / or pressure control(s) configured to control shape, size, and / or pressure of the MLB. In some embodiments, apparatus and related methods relate to a dynamically controlled cerebrospinal fluid (CSF) shunt system.

[0009] Various embodiments may achieve one or more advantages. For example, a vertebral access system (e.g., skeletal body adjustment device (SBAD)) may advantageously be configured and / or operated for discectomy, fusions (e.g., posterior lumbar interbody fusion (PLIFs), transforaminal lumbar interbody fusion (TLIFs), extreme lateral interbody fusion (XLIFs)), collapsed / compressed discs, scoliosis intervention, neuro-foramen compression, and / or bone-on- bone pain.

[0010] Some embodiments may, for example, advantageously provide structural reinforcement modules (e.g., SBAD(s)) adjustable to, for example, advantageously reduce and / or increase mechanical loading applied, such as, for example, based on detected mechanical load profiles.

[0011] Some embodiments may, for example, advantageously deliver one or more therapies. For example, therapies may include, for example, pharmacology therapies, cellular therapies, chemotherapy, bone stimulation agents, bone growth inhibition agents, and / or biologies.

[0012] Some embodiments may, for example, advantageously provide electromagnetic stimulation via a stent, and / or SBAD. For example, electromagnetic stimulation may be advantageously provided through channel(s) in a vertebral body (e.g., via an SBAD).

[0013] Some embodiments may, for example, advantageously provide a stent deployable into a brain ventricle or other nervous system cavity. For example, some embodiments may advantageously be conformable and / or custom created for patient-specific cavity geometry. Some embodiments may, for example, advantageously provide a shunt configured as a brain-computer interface (e.g., sensing, therapy).

[0014] Some embodiments may, for example, advantageously provide a bladder deployable into a body cavity (e.g., a brain ventricle or other nervous system cavity). For example, some embodiments may advantageously provide a conformable bladder configured to selectively apply pressure to a body cavity. For example, some embodiments may advantageously be used to treat bleeding (e.g., via tamponade, irrigation). Some embodiments may, for example, advantageously provide thermal regulation (e.g., via irrigation). Some embodiments may, for example, advantageously reduce adhesion to tissue and / or blood. Some embodiments may regulate a pressure and / or geometry of a shunt and / or bladder.

[0015] Some embodiments, may, for example, advantageously dynamically control cerebrospinal fluid (CSF) flow using sensors and a control module. For example, some embodiments may advantageously provide a minimally invasive CSF shunt. Some embodiments may, for example, advantageously permit CSF flow to be remotely regulated, such as by a healthcare provider, for example. In some embodiments, a CSF shunt may, for example, advantageously automatically regulate CSF flow by automatically adjusting a CSF shunt's operation, such as based on monitored parameters, for example.BRIEF DESCRIPTION OF THE DRAWINGS

[0016] FIG. 1 depicts an illustrative vertebral access system and associated method.

[0017] FIG. 2 and FIG. 3 depict structural reinforcement modules.

[0018] FIG. 4 depicts deployment of an inter-vertebral lead, such as using the system, method, and / or module(s) of FIGS. 1, 2, and / or 3.

[0019] FIG. 5 depicts an illustrative body-conforming stent.

[0020] FIG. 6 depicts an illustrative multi-layer bladder.

[0021] FIG. 7 depicts an illustrative shunt configured, for example, to dynamically regulate flow of cerebrospinal fluid (CSF).

[0022] FIG. 8 depicts an illustrative vertebral access method.

[0023] FIG. 9 and FIG. 10 depict illustrative methods related to structural reinforcement module(s) (e.g., skeletal body adjustment device(s)).

[0024] The details of various embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims.DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0025] FIG. 1 depicts an illustrative vertebral access system and associated method. As shown, a vertebra 105 has one or more processes, including transverse process 110. The vertebra 105 includes one or more pedicles 115. A vertebral access system may, for example, include a steerable catheter 120. The steerable catheter may be operatively, communicably, fluidly, mechanically, optically, and / or electrically coupled to one or more actuators, sensors, and / or interfaces (e.g., as shown). An incision may be made, for example, to access the pedicle 115. An aperture may be formed in the pedicle 115. A channel may be tunneled (motion 1 A) from the aperture at the pedicle 115 to the vertebral body 116. For example, the vertebral body may include marrow. The vertebral body may, for example, have few or no nerves. The spinal cord, as shown, may be disposed in the vertebral foramen.

[0026] Once a tip of the steerable catheter 120 has reached the vertebral body (e.g., near a center of the vertebral body, as shown), the system may be operated such that the tip turns substantially parallel to the spinal column and / or spinal cord 117, along axis 107 (illustrated as protruding out of the page). For example, as shown, the tip may be steered to come ‘out of the page’ towards or away from a viewer of FIG. 1.

[0027] By way of example and not limitation, the vertebral access system and / or method may be configured and / or operated for discectomy. The vertebral access system and / or method may, for example, be configured and / or operated for fusions (e.g., posterior lumbar interbody fusion (PLIFs), transforaminal lumbar interbody fusion (TLIFs), extreme lateral interbody fusion (XLIFs)). The vertebral access system and / or method may, for example, be configured and / or operated to expand discs. The vertebral access system and / or method may, for example, be configured and / or operated for scoliosis interventions. The vertebral access system and / or method may, for example, be configured and / or operated for treating neuro-foramen compression. The vertebral access system and / or method may, for example, be configured and / or operated for alleviate bone-on-bone pain.

[0028] The channel (‘tunnel’) formed into and / or through the vertebral body may, for example, be reinforced and / or modified. For example, structural reinforcement may be deposited. In some implementations, the structural reinforcement may be freely deposited (e.g., extrusion of areinforcing material). The reinforcement material may, for example, be activated (e.g., by mixing components, by photopolymerization, by electrical stimulation, by thermal shifts).

[0029] As shown, in some embodiments, the system may include an endoscope 125 (e.g., as part of and / or operable with the catheter 120).

[0030] In some implementations, for example, the catheter 120 may be operably coupled to an optical actuator. The optical actuator may, for example, advantageously be operated to provide light therapy within the vertebra 105.

[0031] In some embodiments, the catheter 120 may be operably (e.g., electrically) coupled to an electrical stimulation module 135. For example, electrical stimulation may be provided (e.g., to nervous tissue) within the body via the route illustrated in FIG. 1.

[0032] In some embodiments, the catheter 120 may be operably (e.g., fluidly) coupled to a pharmaceutical delivery module 140 (e.g., drug pump, biological agent source). For example, pharmacological therapy may be delivered within the body via the catheter and / or a lumen disposed via the route illustrated in FIG. 1.

[0033] In some embodiments, other tools and / or modules (e.g., diagnostic tools, imaging tools, therapy tools) may, for example, be operably coupled to the catheter 120 and / or introduced into and / or into communication with the body via the route shown in FIG. 1.

[0034] In some implementations, structural reinforcement modules may be delivered into the channel. For example, FIG. 2 and FIG. 3 depict structural reinforcement modules 210 (e.g., skeletal body adjustment device(s)). For example, a reinforcement module 210 may include stacking components. As depicted, an outer stacking element 210 and an inner stacking element 211 may be ‘stacked’ together (e.g., in alternating order, such as shown). The structural reinforcement modules 210 and the inner stacking element 211 may, for example, be slidingly (e.g., telescopically) coupled. For example, the structural reinforcement modules 210 may define one or more inner lumens (e.g., for later access through the channel, for delivery of fluid, for delivery of mechanical and / or electrical components).

[0035] The structural reinforcement modules 210 may, for example, be delivered through and / or into the channel in a collapsed state (not shown). For example, the structural reinforcement modules 210 may be collapsed down along a longitudinal axis (e.g., reverse of motion 2B). Upon delivery to a target deployment site, the structural reinforcement modules 210 may, for example, be expanded (e.g., motion 2B). Expansion may, by way of example and not limitation, be pneumatically and / or hydraulically (e.g., by a balloon), thermally and / or electrically (e.g., shape memory alloys, shape memory polymers including, for example, foams).

[0036] In some implementations, such as shown in FIG. 2, the structural reinforcement modules 210 may be provided with anchoring modules 215. For example, the anchoring modules 215 maybe deployed (e.g., motion 2A) after and / or during expansion of the structural reinforcement modules 210 into a deployed shape. In some implementations, the anchoring modules 215 may, for example, be pointed (e.g., as shown) and / or have a ‘pad’ shape configured to engage (e.g., frictionally) surrounding tissue (e.g., as shown in the ‘zoom-in’ dashed lines to the upper-left of FIG. 2).

[0037] In some implementations, the structural reinforcement modules 210 may be selectively telescoped (e.g., expanded and / or contracted) after anchoring to apply a target (e.g., three- dimensional) mechanical loading to the surrounding tissue. For example, if the structural reinforcement modules 210 spans multiple vertebrae, the structural reinforcement modules 210 may be telescoped longer to longitudinally separate two vertebrae (e.g., ‘jacking’ them apart).

[0038] In some implementations, the structural reinforcement modules 210 may, for example, include anchoring modules 215 inside the structural reinforcement modules 210. The structural reinforcement modules 210 may, for example, be operated (e.g., telescopically) by control members. For example, control members may include tethers 220 (e.g., flexible, rigid), may be attached to the anchoring modules 215 (e.g., internal, external), such as shown in FIG. 3. In some implementations, the tethers 220 may be operated to apply tension between two anchoring modules 215 (e.g., to urge two of the structural reinforcement modules 210 towards each other). In some implementations, one or more of the tethers 220 (e.g., operating as ‘struts’) may be operated to apply compressive force urging anchoring modules 215 apart (e.g., to urge structural reinforcement modules 210 apart). For example, a user may advantageously selectively operate the tethers 220 to anchor to selected anchoring modules 215 and to apply selected forces to the selected anchoring modules 215 to achieve a desired shape (e.g., bent, straight, compressed, expanded) and / or mechanical loading of the structural reinforcement modules 210.

[0039] In some implementations, control members may include screws and / or other inclined planes. In some embodiments, control members may include motors and / or other sources of motive power. In some implementations, control members may include drums and / or cables.

[0040] In some implementations, the control members (e.g., tethers 220 as shown) may be adjustable. For example, a physician may re-access the tethers 220 and tighten or loosen them to apply incremental adjustments over time (e.g., in response to physical growth and / or remodeling). In some implementations, the tethers 220 may be remotely adjustable. For example, the tethers 220 may be coupled to a remote anchor point(s) (e.g., accessible by a physician, such as in and / or out of the body). For example, the tethers 220 may be coupled to an actuator (e.g., motor, fluid pump). The actuator may be operated to adjust the tethers 220. For example, a physician and / or a control module may operate the actuators to achieve a target (e.g., predetermined) geometry, position, and / or mechanical loading. In some implementations, for example, mechanicaladjustment may be made by micro-electromechanical systems (MEMS). In some implementations, by way of example and not limitation, mechanical adjustment may be made by magnetic rowing rods. For example, vertebral mechanical loading may advantageously be applied to shift, lift, and / or straighten components of a spinal column.

[0041] In some implementations, mechanical adjustment parameters may be provided. For example, resistance to sliding and / or rotation of a mechanical joint in and / or between components of the structural reinforcement modules 210 may be provided. Extension adjustments may, for example, be provided. Adjustments may be statically made during implantation. Adjustments may, for example, be dynamically made after implantation (e.g., hours, days, weeks, months, years).

[0042] In some implementations, for example, adjustments may be made in response to detected parameters in surrounding physiology. For example, pressure and / or force (e.g., strain, shear) sensors may be placed and operated to detect mechanical loading of surrounding tissue (e.g., bone, muscle). Sensors may, for example, be configured to detect bone growth. Sensors may, for example, include conductivity sensors. Sensors may, for example, include position, orientation, and / or motion sensors. Sensors may, for example , include analyte detectors (e.g., lab on a chip).

[0043] In some implementations, therapeutic delivery may be made in response (e.g., manually, automatically) to data collected from sensors disclosed herein. For example, notifications may be generated based on signals crossing predetermined thresholds. For example, control signals may be generated based on signals crossing predetermined thresholds. In some implementations, for example, drugs, cells, growth factors, electrical stimulation, light therapy, and / or mechanical adjustment may be delivered in response to local and / or remote sensors. For example, pharmacological therapy may be advantageously timed to correspond to specific events and / or biorhythm cycles detected by the sensors. For example, mechanical loading may be advantageously timed to correspond to specific events and / or biorhythm cycles detected. In some implementations, for example, events and / or biorhythm cycles may be personalized for the patient (e.g., by machine learning models).

[0044] The structural reinforcement modules 210 may, for example, be adjusted to reduce and / or increase mechanical loading applied based on the detected mechanical load profiles. For example, such embodiments may advantageously be operated (e.g., manually, automatically). Such embodiments may, for example, advantageously reduce adjacent body and / or segment disease (e.g., by dynamically adapting to reduce excess mechanical load applied to surrounding tissue).

[0045] For example, the structural reinforcement modules 210 may be configured as an expandable stent (e.g., ‘cage’). The structural reinforcement modules 210 may, for example, be impregnated with one or more active ingredients (e.g., drug-eluting stent). The structural reinforcement modules 210 may be provided with delivery mechanisms (e.g., tubes, fluidpathways, valves) for therapeutic delivery. Therapeutic delivery may, for example, include pharmacology therapies. Therapeutic delivery may, for example, include cellular therapies. Therapeutic delivery may, for example, include chemotherapy (e.g., local chemotherapy). Therapeutic delivery may, for example, include bone stimulation agents. Therapeutic delivery may, for example, include bone growth inhibition agents. Therapeutic delivery may, for example, include biologies.

[0046] In some implementations, therapies may be delivered through mechanisms other than and / or additional to the structural reinforcement modules 210 (e.g., through catheters, pumps). For example, in some implementations, the approach described above may be made without inserting structural reinforcement.

[0047] In some implementations, electromagnetic stimulation may be provided (e.g., through the channel(s) in the vertebral body, integrated in and / or deployed through the structural reinforcement modules). For example, leads may be disposed near the spinal cord. Leads, for example, may be disposed near branching nerves. Leads may, for example, be disposed near the cerebrospinal fluid (CSF). Leads may, for example, include electrical leads (e.g., electrical conductors). Leads may, for example, include optical transmitting leads (e.g., fiber optic cable). For example, a stimulation source (e.g., light source, electrical source) may be selectively operated to apply local electromagnetic stimulation (e.g., electrical stimulation, phototherapy).

[0048] In some implementations, such as shown in FIG. 4, stimulation may be applied to a nerve 410 exiting the vertebra 105. For example, an inter-vertebral body lead 415 may be disposed adjacent to and / or contacting the nerve 410. The inter-vertebral body lead 415 may, for example, be operated to sense and / or stimulate the nerve 410. The inter-vertebral body lead 415 may, for example, terminate in one or more terminal modules 420 (e.g., sensor, stimulator).

[0049] In some implementations, by way of example and not limitation, the inter-vertebral body lead 415 may be connected to a generator 425 (e.g., electrical generator, light generator, chemical pump). The inter-vertebral body lead 415 may, for example, be coupled (e.g., communicatively) to one or more sensors and / or control module(s) 430 disposed in other portions of the body (e.g., brain cortical sensor, such as including electroencephalogram (EEG) monitoring device(s)).

[0050] FIG. 5 depicts an illustrative body-conforming stent. In some implementations, a stent 505 may be deployed into a body cavity. For example, the stent 505 may be configured for a nervous system cavity. By way of example and not limitation, the stent 505 may be configured for a brain ventricle (e.g., frontal ventricle). The stent 505 may, for example, be delivered via an open corticectomy, for example. The stent 505 may, for example, be delivered via an endoscope.

[0051] In the depicted example, the stent 505 may, for example, be deployed by a catheter 510 (e.g., steerable catheter, endoscope). The stent 505 may, for example, be expanded by a balloon515. The stent 505 may, for example, be coupled (e.g., fluidly) to a shunt 525 (e.g., hydrocephalus shunt). The stent 505 may, for example, be connected to and / or provided with one or more sensors and / or actuators 520. For example, a controller 530 may, as depicted, be operably coupled to one or more sensors and / or actuators.

[0052] A body 540 of the stent 505 may, for example, be shaped to fit a ventricle. The stent 505 may, for example, be provided with expandable members 545. The expandable members 545 may, for example, be expanded (e.g., motion 506) before, during, and / or after expansion of the body 540 from a delivery state (e.g., collapsed) to a deployed state (e.g., expanded). The expandable members 545 may, for example, act to provide mechanical and / or communicative (e.g., electrical) contact with surrounding body tissue (e.g., ventricular walls). One or more of the expandable members 545 may, for example, be provided with contact modules 550. For example, the contact modules 550 may include a mechanical anchor (e.g., pad, microneedles). For example, the contact modules 550 may include an electrical contact (e.g., conductive pad). For example, the contact modules 550 may include an actuator (e.g., LED) and / or sensor(s) (e.g., force / pressure sensor, lab on a chip, EEG electrode, fluid flow sensor, CSF analyte(s) sensor).

[0053] The stent 505 may, for example, be impregnated and / or coated with therapeutic agents (e.g., pharmacologic agents). A pump 535 may, for example, deliver therapeutic agents (e.g., in response to a controller 530) via the stent 505.

[0054] Deployment of the stent 505 may, for example, be controlled based on sensors (e.g., in the contact modules 550). In some implementations, by way of example and not limitation, the body 540 may include multiple, selectively deployed segments. The segments may, for example, be independently controlled and / or deployed. For example, a multi-segment deployment may advantageously enable custom fitting of the stent 505 to a specific patient and / or cavity.

[0055] Some embodiments may, for example, be configured to provide a brain-computer interface. For example, electrodes on the stent 505 may expand and / or conform to the ventricle. Some embodiments may, for example, deliver current and / or apply voltage (e.g., multifocal potential) to the ventricle and / or CSF. In some implementations, some electrodes may be configured as anodes and some electrodes may, for example, be configured as cathodes (e.g., for potential ‘steering’).

[0056] Some embodiments may, for example, advantageously be configured and / or operated to treat epilepsy. Some embodiments may, for example, advantageously be configured and / or operated to treat depression (e.g., chronic). Some embodiments may, for example, advantageously be configured and / or operated to treat obsessive compulsive disorder. Some embodiments may, for example, advantageously be configured and / or operated to treat Parkinson’s disease. Some embodiments may, for example, advantageously be configured and / or operated to provide deep brain stimulation. Some embodiments may, for example, advantageously be configured and / oroperated to provide focal drug delivery. Some embodiments may, for example, advantageously be configured and / or operated to provide light catalyzed effects.

[0057] Some embodiments may, for example, advantageously provide multiple modalities. For example, some embodiments may synchronize treatments (e.g., light delivery, electrical stimulation, pharmaceutical delivery, mechanical loading). For example, therapy may be synchronized with each other, with transient events, and / or with biorhythms. Synchronization may, for example ,be predetermined. Synchronization may, for example, be personalized. For example, drug delivery may be timed to achieve maximum effect with minimal dose (e.g., after electrical stimulation, during photo-stimulation, after detected events and / or thresholds).

[0058] In some implementations, by way of example and not limitation, a hydrocephalus shunt (e.g., as disclosed at least with reference to may be provided with backflushing. For example, backflushing may be generated based on pulsatile backflow.

[0059] FIG. 6 depicts an illustrative bladder 605. The bladder 605 may, for example, be selectively deployed in a body cavity. For example, a body cavity 620 may be in neural tissue. For example, the body cavity 620 may be a ventricle in a patient’s brain. Operations may, for example, have been performed in the body cavity 620. In some examples, the body cavity 620 may have been created by surgery (e.g., removing a portion of tissue). The surrounding tissue may be perfused by vasculature 625 (e.g., blood vessels). The vasculature 625 may, for example, bleed into the body cavity 620 in response to intervention (e.g., surgery).

[0060] The bladder 605 may, for example, be configured to conform to at least some of the body cavity 620. For example, the bladder 605 may be configured as a deployable bladder. The bladder 605 may, for example, be multi-segmented. For example, the bladder 605 may include a stent (e.g., stent 505).

[0061] As an illustrative example, such as depicted in FIG. 6, the bladder 605 may be provided with an outer layer 610 and an inner layer 615. The inner layer 615 may, for example, be highly compliant. For example, the inner layer 615 may conform to a shape of the body cavity 620 at or substantially at ambient pressure (e.g., environmental pressure, normal pressure within the body cavity 620).

[0062] The outer layer 610 may, for example, be highly compliant. For example, the outer layer 610 may conform to a shape of the body cavity 620 at or substantially at ambient pressure (e.g., environmental pressure, normal pressure within the body cavity 620).

[0063] The outer layer 610 may, for example, be fluid permeable. For example, the outer layer 610 may include apertures and / or fenestrations. In some implementations, the outer layer 610 may, for example, be porous. For example, the outer layer 610 may be permeable to water. For example, the outer layer 610 may be permeable to normal saline.

[0064] The inner layer 615 may, for example, be fluid-tight (e.g., water-tight, air-tight). Separate (e.g., independent) fluid conduit(s) may lead to a catheter controller 655. For example, the catheter controller 655 may include a handle. The catheter controller 655 may include human -machine interface(s) (e.g., knobs; levers; touchscreens; feedback mechanics such as haptic, audio, visual). The catheter controller 655 may, for example, include automatic control module(s). For example, the catheter controller 655 may communicate with sensors (not shown). Sensor(s) may, for example, be disposed in, on, and / or about the bladder 605. In some implementations, sensors 660 may, for example, be disposed remote the bladder 605 (e.g., EEG leads, analyte monitor, heart rate monitor, oxygenation monitor).

[0065] By way of example and not limitation, the inner layer 615 may, as depicted, define an inner bladder 645. The inner bladder 645 may, for example, be fluid-tight (e.g., water-tight, air-tight). A volume and / or pressure of fluid in the inner bladder 645 may, for example, be selectively controlled (e.g., by a pump 670 fluidly coupled to the inner bladder 645, shown in this example as operably coupled to the 655) to selectively inflate / deflate the inner bladder 645.

[0066] The outer layer 610 may define (e.g., cooperatively with the inner layer 615) an outer volume 650. The outer volume 650 may, for example, be fluid-permeable, such as on an outer surface. The outer volume 650 may be fluidly coupled to a fluid source (e.g., the pump 670). For example, the outer volume 650 may be selectively fluidly coupled to the pump 670 by operation of the catheter controller 655 (e.g., operating one or more valves, not shown).

[0067] In the depicted example, by way of example and not limitation, the bladder 605 is provided with a fluid channel 630. As depicted, the fluid channel 630 is provided with an aperture 635 (e.g., one or more apertures) into the inner bladder 645. For example, the fluid channel 630 may be selectively fluidly coupled (e.g., by a valve(s), not shown) to the inner bladder 645.

[0068] As depicted, the fluid channel 630 is provided with an aperture 640 (e.g., one or more apertures) to an outer surface of the bladder 605. For example, the fluid channel 630 may be selectively fluidly coupled (e.g., by a valve(s), not shown) to the body cavity 620.

[0069] In some examples, the fluid channel 630 may, for example, be provided with one or more apertures (not shown) to the outer volume 650. For example, the fluid channel 630 may be selectively fluidly coupled (e.g., by a valve(s), not shown) to the outer volume 650.

[0070] In an illustrative method of operation, the bladder 605 may be operated into a deployment state. For example, the bladder 605 may be collapsed about a longitudinal axis (e.g., the fluid channel 630). For example, the bladder 605 may be collapsed in a deployment state to be operated into the body cavity 620 (e.g., in a minimally invasive approach).

[0071] Once the bladder 605 is in the body cavity 620, the bladder 605 may be operated into a deployed state. For example, the inner bladder 645 may be expanded (e.g., by filling with fluidand / or pressurizing with fluid). One or more sensors 660 may, for example, monitor one or more attributes. A sensor 660 may, for example, monitor temperature. A sensor 660 may, for example, monitor continuity. A sensor 660 may, for example, monitor conductivity. A sensor 660 may, for example, monitor electric resistance. A sensor 660 may, for example, monitor pressure. A sensor 660 may, for example, monitor strain. A sensor 660 may, for example, monitor compliance. A sensor 660 may, for example, monitor contact. A sensor 660 may, for example, monitor distance. A sensor 660 may, for example, monitor motion. A sensor 660 may, for example, monitor orientation.

[0072] For example, the inner bladder 645 may be inflated until a target pressure threshold is reached. As an illustrative example, after surgery, the vasculature 625 may be bleeding into the body cavity 620. The inner bladder 645 may be inflated (e.g., via the fluid channel 630) until the bladder 605 is pressurized against the surface of the body cavity 620 (e.g., against brain tissue). For example, the bladder 605 may effectively act to tamponade the surface of the body cavity 620. The pressure may, for example, slow or stop bleeding of the vasculature 625.

[0073] The bladder 605 may be left pressurized for a period of time (e.g., minutes, hours, days, or more). In some examples, the bladder 605 may be left pressurized for 1-5 days (e.g., 1-3 days). The pressure, volume, and / or shape of the bladder 605 may, for example, be adjusted over time. For example, the bladder 605 may be adjusted as a function of feedback from one or more sensor 660. For example, the bladder 605 may be slowly depressurized over the course of several days to allow the tissue to adjust and / or heal. Once bleeding has stopped, for example, the bladder 605 may be collapsed and removed.

[0074] In some examples, the bladder 605 may be provided with a non-stick coating. For example, the outer layer 610 may be resistant to adhesion of the brain tissue and / or blood.

[0075] In some examples, the bladder 605 may be irrigated. For example, an external surface of the bladder 605 may be irrigated. Irrigation may, for example, advantageously reduce adhesion of tissue and / or blood to the bladder 605. In the depicted example, the outer volume 650 may, for example, be supplied with a fluid. The fluid may, for example, include normal saline. The outer layer 610 may, for example, be permeable to the fluid.

[0076] Irrigation may, for example, be performed periodically. Irrigation may, for example, be performed continuously. Irrigation may, for example, be performed on demand. In some embodiments, additives may be delivered via the irrigation. For example, therapeutic agents such as pharmaceuticals (e.g., clotting factors, chemotherapy agents, antibiotics) may be delivered via irrigation and / or through the outer layer 610 and inner bladder 645.

[0077] As an illustrative example, filling of the outer volume 650 may be synchronized with reduction in volume of the inner bladder 645. Such embodiments may, for example, advantageously avoid over-pressurization of the body cavity 620.

[0078] By way of example and not limitation, some embodiments may oscillate pressure and / or volume of the bladder 605. For example, oscillating pressure and / or volume may induce oscillating dimension(s) of the bladder 605. The oscillation may, for example, release ‘sticking’ of the bladder 605 to tissue and / or blood. The oscillation may, for example, be induced by pulsation of fluid in the inner bladder 645 and / or outer volume 650.

[0079] As an illustrative example, when the bladder 605 is to be removed, the inner bladder 645 may be reduced in volume (e.g., via the aperture 635 and the fluid channel 630). The outer volume 650 may be pressurized such that at least a portion of the outer surface of the bladder 605 is irrigated (e.g., through the outer layer 610). The irrigation may, by way of example and not limitation, be performed for minutes. The irrigation may, for example, be performed for hours (e.g., several hours). The pressure applied to the tissue by the bladder 605 may be reduced (e.g., gradually over several hours or days). Once the bladder 605 is no longer applying substantive pressure to the tissue in the body cavity 620, the bladder 605 may be fully deflated (e.g., via the fluid channel 630). Cords 665 may, for example, be disposed in and / or about one or more of the layers (e.g., the outer layer 610, the inner layer 615). The cords 665 may, for example, be pulled to constrain the bladder 605 into a shape suitable for withdrawal (e.g., collapsed along a longitudinal axis, such as rather than bunched / wadded).

[0080] In some examples, internal struts and / or tethers 675 may, for example, constrain geometry of the bladder 605. For example, the struts and / or tethers may prevent balling or wadding of the bladder 605. For example, the tethers 675 may constrain the bladder 605 into a longitudinally extending shape when collapsed. In some examples, the tethers 675 may, for example, be elastic (e.g., stretchable when the bladder 605 is pressurized, with a return to substantially the same length when pressure is released).

[0081] One or more of the sensor 660 may, for example, monitor for bleeding. For example, analyte sensor(s) may monitor for the presence of blood and / or bleeding-related components (e.g., hemoglobin). For example, optical sensor(s) may monitor for a color of fresh blood. For example, temperature sensor(s) may monitor for a change in temperature corresponding to bleeding. For example, conductivity sensors, resistance sensors, and / or capacitance sensors may monitor for a change in conductivity, resistance, and / or capacitance corresponding to the presence of fresh blood. Deflation and / or inflation of the bladder 605 may be adjusted and / or therapeutical agent(s) may be delivered in response to the detection of blood.

[0082] In some examples, the bladder 605 may be operated to irrigate the body cavity 620 with a thermally differentiated fluid (e.g., by a pump such as pump 670). For example, the body cavity 620 may be irrigated with cooler fluid to cool the body cavity 620 and / or surrounding tissue. For example, the body cavity 620 may be irrigated with warmer fluid to warm the body cavity 620 and / or surrounding tissue.

[0083] In some examples, the bladder 605 may operate as a thermal source and / or sink. For example, fluid may be circulated in the inner bladder 645 and / or outer volume 650. For example, the outer layer 610 and / or connective structures to the inner layer 615 may be thermally conductive (e.g., metallic, graphene, carbon). The inner bladder 645 may, for example, be operated as a fluid heatsink and / or heat exchange. Fluid may be circulated to introduce cooler fluid (e.g., with or without irrigation). Such examples may, for example, be configured and / or operated to cool the body cavity 620 and / or surrounding tissue.

[0084] In some examples, the bladder 605 may be fluidly coupled to a heat source (e.g., heater) and / or heatsink (e.g., for refrigeration unit). The heat source and / or heatsink may, for example, be remote (e.g., external to the body). In some examples, the heat source and / or heatsink may be disposed on and / or in the body (e.g., an implant). For example, fluid may be circulated (e.g., by an internal pump) through / across a heatsink thermally coupled to a cooler portion of the body (e.g., an external surface of the patient, such as in an air-conditioned environment).

[0085] In some examples, the inner bladder 645 may be operated as a fluid heat source. Fluid may be circulated to introduce warmer fluid. Such examples may be configured and / or operated to warm the body cavity 620 and / or surrounding tissue, for example.

[0086] In some examples, cooling brain tissue by as little as 2-3°F may reduce or cure epilepsy.

[0087] The bladder 605 may, for example, be configured and / or operated to treat brain trauma. The bladder may, for example, be configured and / or operated to treat epilepsy. The bladder may, for example, be configured and / or operated for treat meningitis. The bladder 605 may, for example, be configured and / or operated for treat neuro-inflammation. The bladder 605 may, for example, be configured and / or operated for treat Alzheimer’s.

[0088] In some embodiments, such as depicted, a sealing member 680 and / or a sealing member 685 may be provided. For example, the sealing member(s) may be configured as a single or multiple (e.g., nested) collar(s). The sealing member(s) may, for example, seal against the fluid channel 630 (e.g., conduit). For example, the collar(s) may be sliding relative to each other. In some implementations, such as shown, the control members(s) (e.g., cords 665) may be configured to be operated through the sealing member(s), for example.

[0089] FIG. 7 depicts an illustrative shunt 705. For example, the shunt 705 may be configured and / or operated as a brain shunt (as depicted). The shunt 705 may, for example, be configuredand / or operated as a hydrocephalus shunt. In the depicted example, the shunt 705 is implanted in a patient’s brain 702 (e.g., fluidly coupled to a body cavity 620, such as a frontal ventricle) such as, for example, through the patient’s skull 701. The shunt 705, in the depicted example, is coupled to a controller 745 (e.g., which may include and / or be coupled to a catheter controller 655). The shunt 705 may, for example, be fluidly coupled to a pump 750. The pump 750, as depicted, is operably coupled to the controller 745.

[0090] In some embodiments, such as shown, the shunt 705 terminates in a body cavity 620. The shunt 705 may be provided (e.g., at a distal end in the body cavity 620) with apertures 710. Fluid in the body cavity 620 may, for example, enter the shunt 705 via the apertures 710. The fluid may, for example, be disposed of via the shunt 705 (e.g., via the pump 750).

[0091] In some examples, tissue (e.g., brain tissue) may grow onto and / or anchor to the shunt 705. For example, the tissue may grow to at least partially occlude the apertures 710. Some embodiments may, for example, backflush to expel fluid 720 through the apertures 710. The backflushing may, for example, be performed automatically (e.g., in response to a signal from the controller 745).

[0092] In some implementations, the backflushing may be controlled according to a relationship, such as shown in plot 725. For example, backflushing may be operated for a specific time and / or volume as a function of an amount of fluid drained from the body cavity 620 through the shunt 705. For example, one or more sensors 740 may monitor fluid flow and / or pressure (e.g., intracranial pressure). A predetermined ratio (e.g., or ratio range) may be set for volume dispensed (V_D) to volume backflushed (V_B). As an illustrative example, without limitation, backflushing may be operated according to a 2: 1 ratio of V_D : V_B. For example, the controller 745 may operate valves and / or the pump 750 to backflush periodically based on V_D and / or V_B.

[0093] In some implementations, backflushing may be pulsatile. For example, the controller 745 may operate valves and / or the pump 750 to pulse fluid (e.g., at transiently elevated pressures relative to normal pressure in the brain) and / or to oscillate fluid (e.g., transient pressure burst out of the shunt 705 followed by transient pressure suction into the shunt 705).

[0094] In some examples, the backflushing relationship may be adjustable (e.g., by a physician). The backflushing relationship may, for example, be learned (e.g., based on pressure and / or fluid flow data for the patient). For example, as static pressure rises and / or a flow of dispensing (Q_D) decreases, a backflushing relationship may be increased to increase backflushing. The increased backflushing may, for example, advantageously reduce occlusion.

[0095] In some implementations, by way of example and not limitation, multiple channels may be operated to cooperate to irrigate the surface of the shunt 705. For example, fluid may be dispensed from some apertures 710 and suction may be applied to corresponding (e.g., adjacent) apertures710. For example, simultaneous coordinated dispensing and suction may induce fluid flow across the surface of the shunt 705. The irrigation may, for example, advantageously induce localized elevated fluid flow sufficient to disrupt tissue anchored to the shunt 705. The localized elevated fluid flow may, for example, prevent or reduce damage to surrounding brain tissue.

[0096] In some implementations, for example, the shunt 705 may be pulsed. For example, the shunt 705 may be transiently operated to an expanded state 705E (e.g., motion 715), before being returned (e.g., actively, elastically) to the normal state (e.g., motion 715). The pulsation may, for example, advantageously disrupt anchoring of unwanted tissue onto the shunt 705.

[0097] In some examples, actuator(s) may be positioned on or near the surface of the shunt 705 and / or in or near the apertures 710. For example, the actuators 755 may include ultrasonic emitters. The actuators 755 may, for example, be operated (e.g., periodically) to disrupt growth and / or anchoring of unwanted tissue. The actuators 755 may, for example, advantageously prevent occlusion of the apertures 710.

[0098] In some examples, the actuators 755 may include electrical emitters. For example, the electrical emitters may induce a low level of electrical current in the shunt 705 itself. The electrical current may, for example, advantageously inhibit or prevent occlusion of the apertures 710 by unwanted tissue.

[0099] In some implementations, for example, the shunt 705 may be provided with a coating 730. In some examples, the shunt 705 may be impregnated with components 735. The coating 730 and / or the components 735 may, for example, prevent and / or inhibit anchoring and / or growth of the unwanted tissue. In some examples, the components 735 may migrate to the surface and / or diffuse out (e.g., the shunt 705 may be drug-eluting).

[0100] In some examples, the shunt 705 may be operated to irrigate the body cavity 620 with a thermally differentiated fluid (e.g., by a pump such as pump 750. For example, the body cavity 620 may be irrigated with cooler fluid to cool the body cavity 620 and / or surrounding tissue. For example, the body cavity 620 may be irrigated with warmer fluid to warm the body cavity 620 and / or surrounding tissue.

[0101] In some examples, the shunt 705 may operate as athermal source and / or sink. For example, fluid may be circulated in an inner cavity and / or lumen of the shunt 705. For example, an outer layer and / or connective structures to the inner cavity may be thermally conductive (e.g., metallic, graphene, carbon). The inner cavity may, for example, be operated as a fluid heatsink and / or heat exchange. Fluid may be circulated to introduce cooler fluid (e.g., with or without irrigation). Such examples may, for example, be configured and / or operated for cool the body cavity 620 and / or surrounding tissue.

[0102] In some examples, the shunt 705 may be fluidly coupled to a heat source (e.g., heater) and / or heatsink (e.g., for refrigeration unit). The heat source and / or heatsink may, for example, be remote (e.g., external to the body). In some examples, the heat source and / or heatsink may be disposed on and / or in the body (e.g., an implant). For example, fluid may be circulated (e.g., by an internal pump) through / across a heatsink thermally coupled to a cooler portion of the body (e.g., an external surface of the patient, such as in an air-conditioned environment).

[0103] In some examples, the shunt 705 may be operated as a fluid heat source. Fluid may be circulated to introduce warmer fluid. Such examples may be configured and / or operated to warm the body cavity 620 and / or surrounding tissue, for example.

[0104] In some examples, cooling brain tissue by as little as 2-3°F may reduce or cure epilepsy.

[0105] The shunt 705 may, for example, be configured and / or operated to treat brain trauma. The shunt 705 may, for example, be configured and / or operated to treat epilepsy. The shunt 705 may, for example, be configured and / or operated to treat meningitis. The shunt 705 may, for example, be configured and / or operated for treat neuro-inflammation. The shunt 705 may, for example, be configured and / or operated to treat Alzheimer’s. In some examples, the shunt 705 may provide at least a component of a brain-computer interface. In some examples, the shunt 705 may be configured and / or operated to deliver and / or to determine target (e.g., optimal) delivery times of therapeutic agents (e.g., locally, systemically, remote). In some examples, the shunt 705 may be configured and / or operated to treat hydrocephalus. In some examples, the shunt 705 may be used pre and / or post brain surgery. In some examples, the shunt 705 may be configured and / or operated for brain pacing (e.g., electrical pacing). In some examples, the shunt 705 may be configured and / or operated for limb state management.

[0106] FIG. 8 depicts an illustrative vertebral access method, such as disclosed, for example, with respect to FIGS. 1-2. In a method 800, a first vertebral body (VB) is accessed (step 805) via the corresponding pedicle. A counter variable (e.g., “i”, as depicted) is initialized (e.g., to ‘ 1’ as shown in step 810). A device (e.g., catheter with steerable drill tip) is advanced through the resulting lumen (step 810) and into the first (ith) vertebral body (step 815). The counter is incremented (step 820) and the catheter advanced, into subsequent vertebral bodies (e.g., through and / or around intervening discs) until the number (“n”) of vertebral bodies to be accessed is reached (step 825), where n >= 1. In some implementations, each vertebral body may be independently accessed via the corresponding pedicle(s) (e.g., steps 805-825 may be repeated multiple times, such as where n = 1 for each or at least some of the repetitions). Subsequent operation(s) may, for example, be performed (steps 830), as depicted (e.g., as described with respect to, by way of example and not limitation, FIGS. 1-4).

[0107] FIG. 9 and FIG. 10 depict illustrative methods related to structural reinforcement module(s) (e.g., skeletal body adjustment device(s)). In a method 900, a counter variable i is initialized to 1 (step 905), and the ith body of a SBAD (e.g., 210 and / or 211) is disposed into an ith vertebral body (step 910). The variable is incremented and the process repeated until n SBAD bodies have been placed (step 920), where n >= 1. The counter i is reinitialized to 1 (step 922), and the ith is operated (e.g., expanded, anchor(s) deployed) to couple to the corresponding ith vertebral body (step 930), and the counter incremented (step 930) and process repeated until the n SBAD bodies have been coupled (step 935). In some implementations, only selected bodies (e.g., m selected bodies < n selected bodies) may, for example, be operated to couple. In some implementations, bodies may, for example, be placed and / or coupled asynchronously (e.g., out of integer order). In some implementations, a further step(s) may include coupling bodies together (e.g., stacking, fastening, such as 210 to 211)

[0108] As depicted, control member(s) (e.g., 220) are operated (step 940) (e.g., tightened, pulled, expanded, loosened) such that displacement of corresponding vertebrae are induced. For example, all control members may be operated. Control member(s) of selected SBADs may, for example, be operated (e.g., identically, differentially such as in different directions). Step 940 may, for example, be repeated, as shown, until a target displacement is reached (step 945).

[0109] FIG. 10 depicts a method 1000 in which the ith body is operated to couple (step 925) directly after placing the ith body (step 910).

[0110] Some implementations (e.g., of method 900, method 1000) may, for example, include additional steps such as, by way of example and not limitation: imaging; sensor reading such as pressure, force, shear, orientation; trajectory prediction; differential analysis to determine a difference between a pre-adjustment configuration, a post-adjustment configuration, and / or a predicted post-adjustment configuration.

[0111] Although various embodiments have been described with reference to the figures, other embodiments are possible. In some implementations, for example, the steerable catheter 120, structural reinforcement modules 210, stent 505, bladder 605, shunt 705, and / or associated devices (e.g., controllers, sensors, actuators) may be connected to and / or configured according to one or more devices. Example devices include those disclosed at least with reference to:• FIGS. 1-4 of U.S. Application Serial No. 18 / 313,249, titled “Dynamically Controlled Cerebrospinal Fluid Shunt,” filed by Samuel Robert Browd, et al., on May 5, 2023 (e.g., including shunt devices and associated devices)• FIGS. 1-9 of U.S. Application Serial No. 63 / 365,407, titled "Distributed Sensing and Control of Cerebrospinal Fluid," filed by Samuel Robert Browd, et al., on May 26, 2022 (e.g., including brain shunt(s), CSF ion exchange device(s), light therapy device(s);• FIG. 1 of U.S. Application Serial No. 63 / 477,158, titled "Central Nervous System Monitoring and Intervention," filed by Samuel Robert Browd, et al., on December 23, 2022 (e.g., “shunt 105” and associated devices);• Paragraphs [0003-0040] of U.S. Application Serial No. 63 / 477,162, titled "Cerebrospinal Fluid Polarization," filed by Samuel Robert Browd, et al., on December 23, 2022 (e.g., a cerebrospinal fluid (CSF) polarization system (CSFPS) and associated devices);• FIGS. 1-32 of U.S. Application Serial No. 63 / 488,412, titled "Dynamic Shunt Systems," filed by Samuel Robert Browd, et al., on March 3, 2023 (e.g., smart shunt(s), non-invasive shunt diagnostic devices / systems, implant devices); and• co-pending U.S. Application titled “Dynamic Guided Physician-Patient Interaction Engine,” filed by Samuel Robert Browd, et al., on October 13, 2023 (e.g., “patientphysician interaction engine (PPIE 110)” and associated devices); the entire contents of which applications are incorporated herein by reference.

[0112] Although an exemplary system has been described with reference to the figures, other implementations may be deployed in other industrial, scientific, medical, commercial, and / or residential applications.

[0113] In various embodiments, some bypass circuits implementations may be controlled in response to signals from analog or digital components, which may be discrete, integrated, or a combination of each. Some embodiments may include programmed, programmable devices, or some combination thereof (e.g., PLAs, PLDs, ASICs, microcontroller, microprocessor), and may include one or more data stores (e.g., cell, register, block, page) that provide single or multi-level digital data storage capability, and which may be volatile, non-volatile, or some combination thereof. Some control functions may be implemented in hardware, software, firmware, or a combination of any of them.

[0114] Computer program products may contain a set of instructions that, when executed by a processor device, cause the processor to perform prescribed functions. These functions may be performed in conjunction with controlled devices in operable communication with the processor. Computer program products, which may include software, may be stored in a data store tangibly embedded on a storage medium, such as an electronic, magnetic, or rotating storage device, and may be fixed or removable (e.g., hard disk, floppy disk, thumb drive, CD, DVD).

[0115] Although an example of a system, which may be portable, has been described with reference to the above figures, other implementations may be deployed in other processing applications, such as desktop and networked environments.

[0116] Temporary auxiliary energy inputs may be received, for example, from chargeable or single use batteries, which may enable use in portable or remote applications. Some embodimentsmay operate with other DC voltage sources, such as 9V (nominal) batteries, for example. Alternating current (AC) inputs, which may be provided, for example from a 50 / 60 Hz power port, or from a portable electric generator, may be received via a rectifier and appropriate scaling. Provision for AC (e.g., sine wave, square wave, triangular wave) inputs may include a line frequency transformer to provide voltage step-up, voltage step-down, and / or isolation.

[0117] Although particular features of an architecture have been described, other features may be incorporated to improve performance. For example, caching (e.g., LI, L2, . . .) techniques may be used. Random access memory may be included, for example, to provide scratch pad memory and or to load executable code or parameter information stored for use during runtime operations. Other hardware and software may be provided to perform operations, such as network or other communications using one or more protocols, wireless (e.g., infrared) communications, stored operational energy and power supplies (e.g., batteries), switching and / or linear power supply circuits, software maintenance (e.g., self-test, upgrades), and the like. One or more communication interfaces may be provided in support of data storage and related operations.

[0118] Some systems may be implemented as a computer system that can be used with various implementations. For example, various implementations may include digital circuitry, analog circuitry, computer hardware, firmware, software, or combinations thereof. Apparatus can be implemented in a computer program product tangibly embodied in an information carrier, e.g., in a machine-readable storage device, for execution by a programmable processor; and methods can be performed by a programmable processor executing a program of instructions to perform functions of various embodiments by operating on input data and generating an output. Various embodiments can be implemented advantageously in one or more computer programs that are executable on a programmable system including at least one programmable processor coupled to receive data and instructions from, and to transmit data and instructions to, a data storage system, at least one input device, and / or at least one output device. A computer program is a set of instructions that can be used, directly or indirectly, in a computer to perform a certain activity or bring about a certain result. A computer program can be written in any form of programming language, including compiled or interpreted languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, or other unit suitable for use in a computing environment.

[0119] Suitable processors for the execution of a program of instructions include, by way of example, both general and special purpose microprocessors, which may include a single processor or one of multiple processors of any kind of computer. Generally, a processor will receive instructions and data from a read-only memory or a random-access memory or both. The essential elements of a computer are a processor for executing instructions and one or more memories forstoring instructions and data. Generally, a computer will also include, or be operatively coupled to communicate with, one or more mass storage devices for storing data files; such devices include magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and optical disks. Storage devices suitable for tangibly embodying computer program instructions and data include all forms of non-volatile memory, including, by way of example, semiconductor memory devices, such as EPROM, EEPROM, and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks. The processor and the memory can be supplemented by, or incorporated in, ASICs (applicationspecific integrated circuits).

[0120] In some implementations, each system may be programmed with the same or similar information and / or initialized with substantially identical information stored in volatile and / or nonvolatile memory. For example, one data interface may be configured to perform auto configuration, auto download, and / or auto update functions when coupled to an appropriate host device, such as a desktop computer or a server.

[0121] In some implementations, one or more user-interface features may be custom configured to perform specific functions. Various embodiments may be implemented in a computer system that includes a graphical user interface and / or an Internet browser. To provide for interaction with a user, some implementations may be implemented on a computer having a display device. The display device may, for example, include an LED (light-emitting diode) display. In some implementations, a display device may, for example, include a CRT (cathode ray tube). In some implementations, a display device may include, for example, an LCD (liquid crystal display). A display device (e.g., monitor) may, for example, be configured and / or operated for displaying information to the user. Some implementations may, for example, include a keyboard and / or pointing device (e.g., mouse, trackpad, trackball joystick), such as by which the user can provide input to the computer.

[0122] In various implementations, the system may communicate using suitable communication methods, equipment, and techniques. For example, the system may communicate with compatible devices (e.g., devices capable of transferring data to and / or from the system) using point-to-point communication in which a message is transported directly from the source to the receiver over a dedicated physical link (e.g., fiber optic link, point-to-point wiring, daisy-chain). The components of the system may exchange information by any form or medium of analog or digital data communication, including packet-based messages on a communication network. Examples of communication networks include, e.g., a LAN (local area network), a WAN (wide area network), MAN (metropolitan area network), wireless and / or optical networks, the computers and networks forming the Internet, or some combination thereof. Other implementations may transport messagesby broadcasting to all or substantially all devices that are coupled together by a communication network, for example, by using omni-directional radio frequency (RF) signals. Still other implementations may transport messages characterized by high directivity, such as RF signals transmitted using directional (i.e., narrow beam) antennas or infrared signals that may optionally be used with focusing optics. Still other implementations are possible using appropriate interfaces and protocols such as, by way of example and not intended to be limiting, USB 2.0, Firewire, ATA / IDE, RS-232, RS-422, RS-485, 802.11 a / b / g, Wi-Fi, Ethernet, IrDA, FDDI (fiber distributed data interface), token-ring networks, multiplexing techniques based on frequency, time, or code division, or some combination thereof. Some implementations may optionally incorporate features such as error checking and correction (ECC) for data integrity, or security measures, such as encryption (e.g., WEP) and password protection.

[0123] In various embodiments, the computer system may include Internet of Things (loT) devices. loT devices may include objects embedded with electronics, software, sensors, actuators, and network connectivity which enable these objects to collect and exchange data. loT devices may be in-use with wired or wireless devices by sending data through an interface to another device. loT devices may collect useful data and then autonomously flow the data between other devices.

[0124] Various examples of modules may be implemented using circuitry, including various electronic hardware. By way of example and not limitation, the hardware may include transistors, resistors, capacitors, switches, integrated circuits, other modules, or some combination thereof. In various examples, the modules may include analog logic, digital logic, discrete components, traces and / or memory circuits fabricated on a silicon substrate including various integrated circuits (e.g., FPGAs, ASICs), or some combination thereof. In some embodiments, the module(s) may involve execution of preprogrammed instructions, software executed by a processor, or some combination thereof. For example, various modules may involve both hardware and software.

[0125] In some aspects, the techniques described herein relate to a skeletal body adjustment device including: a first body configured to be coupled within a first skeletal body; a second body configured to be coupled within a second skeletal body, the first body telescopically connected to the second body; at least one control member coupled to the first expanding body and the second expanding body such that operating the at least one control member telescopically translates at least one of the first body and the second body relative to each other such that corresponding motion is induced of at least one of the first skeletal body and the second skeletal body relative to each other.

[0126] In some aspects, the techniques described herein relate to a skeletal body adjustment device, wherein at least one of the first body and the second body are expandable.

[0127] In some aspects, the techniques described herein relate to a skeletal body adjustment device, wherein the at least one of the first body and the second body includes an expandable stent.

[0128] In some aspects, the techniques described herein relate to a skeletal body adjustment device, further including: an anchor coupled to at least one of the first body and the second body, the anchor configured to couple to the at least one of the first body and the second body to a corresponding at least one skeletal body of the first skeletal body and the second skeletal body.

[0129] In some aspects, the techniques described herein relate to a skeletal body adjustment device, wherein the anchor is selectively operably from at least a stowage mode to a deployed mode, the deployed mode corresponding to coupling to the corresponding at least one skeletal body.

[0130] In some aspects, the techniques described herein relate to a skeletal body adjustment device, wherein the anchor is selectively operable from the deployed mode to the stowage mode, the stowage mode corresponding to decoupling from the corresponding at least one skeletal body.

[0131] In some aspects, the techniques described herein relate to a skeletal body adjustment device, further including a sensor coupled to at least one of the first body and the second body.

[0132] In some aspects, the techniques described herein relate to a skeletal body adjustment device, wherein the sensor includes at least one conductive lead coupled to and / or integrated into the anchor.

[0133] In some aspects, the techniques described herein relate to a skeletal body adjustment device, further including a controller operably coupled to selectively operate the at least one control member.

[0134] In some aspects, the techniques described herein relate to a skeletal body adjustment device, wherein the controller is operably coupled to a sensor coupled to at least one of the first body and the second body.

[0135] In some aspects, the techniques described herein relate to a skeletal body adjustment device, wherein the controller selectively operates the at least one control member based on input from at least one sensor.

[0136] In some aspects, the techniques described herein relate to a skeletal body adjustment device, further including a delivery mechanism.

[0137] In some aspects, the techniques described herein relate to a skeletal body adjustment device, wherein the delivery mechanism includes a conductive lead coupled to and / or integrated into the anchor.

[0138] In some aspects, the techniques described herein relate to a skeletal body adjustment device and 13, wherein the conductive lead is optically conductive.

[0139] In some aspects, the techniques described herein relate to a skeletal body adjustment device and 13-14, wherein the conductive lead is electrically conductive.

[0140] In some aspects, the techniques described herein relate to a skeletal body adjustment device, further including at least a second of said anchor.

[0141] In some aspects, the techniques described herein relate to a skeletal body adjustment device, wherein: the first body includes a first lumen, the second body includes a second lumen, and the first lumen is in fluid communication with the second lumen.

[0142] In some aspects, the techniques described herein relate to a method 1-16 such that the first body is disposed within the first vertebral body, and the second body is disposed within the second vertebral body; couple the first body to the first vertebral body; couple the second body to the second vertebral body; and, operate the control member such that at least one of the first body and the second body are displaced relative to each other such that corresponding displacement is induced in at least one of the first vertebral body and the second vertebral body.

[0143] In some aspects, the techniques described herein relate to a method, wherein operating the control member includes operating a tether.

[0144] In some aspects, the techniques described herein relate to a method, wherein the displacement of the at least one of the first body and the second body includes telescopic extension of the skeletal body adjustment device, and the corresponding displacement of the at least one of the first skeletal body and the second skeletal body includes extension of the spinal column.

[0145] In some aspects, the techniques described herein relate to a method, further including operating at least one anchor into a deployed mode such that at least one of the first body and the second body are coupled to a corresponding at least one of the first skeletal body and the second skeletal body.

[0146] In some aspects, the techniques described herein relate to a method, further including advancing a catheter through a lumen of the skeletal body adjustment device.

[0147] In some aspects, the techniques described herein relate to a method, further including advancing a lead through and / or from the skeletal body adjustment device and into proximity to nerve tissue such that the lead is configured to monitor and / or stimulate the nerve tissue.

[0148] In some aspects, the techniques described herein relate to a body cavity engagement device including: an expandable stent configured to conform to a body cavity in an expanded configuration; a plurality of contact modules extending at least partially to an exterior of the expandable stent, the plurality of contact modules configured to contact tissue defining the body cavity and configured to communicably couple to a controller.

[0149] In some aspects, the techniques described herein relate to a body cavity engagement device, wherein the expandable stent is configured to be disposed in a ventricle of a human brain.

[0150] In some aspects, the techniques described herein relate to a body cavity engagement device, wherein the expandable stent includes a three-dimensionally oval shape of the exterior.

[0151] In some aspects, the techniques described herein relate to a body cavity engagement device, wherein at least one of the contact modules includes a sensor.

[0152] In some aspects, the techniques described herein relate to a body cavity engagement device, wherein at least one of the contact modules includes a conductive lead.

[0153] In some aspects, the techniques described herein relate to a body cavity engagement device, wherein the conductive lead is configured to selectively communicate electrical energy.

[0154] In some aspects, the techniques described herein relate to a body cavity engagement device, wherein the conductive lead is configured to selectively communicate optical energy.

[0155] In some aspects, the techniques described herein relate to a body cavity engagement device, wherein at least one of the contact modules is configured as an anchor.

[0156] In some aspects, the techniques described herein relate to a body cavity engagement device, wherein at least one of the contact modules is selectively deployable in response to a signal from the controller.

[0157] In some aspects, the techniques described herein relate to a body cavity engagement device, wherein a plurality of the contact modules are individually selectively deployable.

[0158] In some aspects, the techniques described herein relate to a body cavity engagement device, further including a therapeutic agent impregnated in the stent.

[0159] In some aspects, the techniques described herein relate to a body cavity engagement device, configured as a brain-computer interface.

[0160] In some aspects, the techniques described herein relate to a body cavity engagement device, configured and / or operated to treat at least one epilepsy, depression, and Parkinson's disease.

[0161] In some aspects, the techniques described herein relate to a bladder including: a fluid permeable outer layer defining a first chamber; an impermeable inner layer disposed within the outer wall and defining both a second chamber between the outer layer and the inner layer and a third chamber within the inner layer; a conduit defining a lumen and disposed within the inner wall and in fluid communication with the third chamber and an exterior of the outer layer; and, at least one control member configured to selectively operate the outer layer and / or the inner layer between a plurality of spatial configurations.

[0162] In some aspects, the techniques described herein relate to a bladder, wherein: a first of the plurality of spatial configurations includes a stowage mode in which the outer layer and the inner layer are collapsed along the conduit, a second of the plurality of spatial configurations includes a deployed mode in which the outer layer and the inner layer are inflated.

[0163] In some aspects, the techniques described herein relate to a bladder, wherein the at least one control member is configured to operate at least the outer layer from the deployed mode to the stowage mode.

[0164] In some aspects, the techniques described herein relate to a bladder, wherein operating at least one of the outer layer and the inner layer from the stowage mode to the deployed mode includes providing a fluid such that the at least one of the outer layer and the inner layer are inflated.

[0165] In some aspects, the techniques described herein relate to a neurosurgery method including: provide the bladder in a stowage mode; introduce the bladder into a neural tissue cavity; inflate the bladder into a first deployed mode having a first size; and, operate the at least one control member of the bladder to operate the bladder into a second deployed mode having a second size.

[0166] In some aspects, the techniques described herein relate to a method, further including: introduce fluid into the first cavity such that at least a portion of an exterior surface of the outer layer is flushed.

[0167] In some aspects, the techniques described herein relate to a method, further including: retrieve fluid from the body cavity via the lumen.

[0168] In some aspects, the techniques described herein relate to a method, wherein the neural tissue cavity includes a brain ventricle.

[0169] In some aspects, the techniques described herein relate to a cerebrospinal fluid (CSF) shunt system including: a shunt configured to be implanted in a patient's body in fluid communication with CSF; sensors operably coupled to the shunt; a control module operatively connected to the sensors, the control module configured to adjust the operation of the shunt based on a at least one predetermined parameter; and, valves operatively connected to the control module and selectively operable by the control modules such that CSF flow is dynamically regulated.

[0170] In some aspects, the techniques described herein relate to a CSF shunt system, further including: a pump operatively connected to the shunt, the pump configured to deliver therapeutic agents through the shunt.

[0171] In some aspects, the techniques described herein relate to a CSF shunt system, wherein the control module is configured to adjust the operation of the shunt remotely.

[0172] In some aspects, the techniques described herein relate to a CSF shunt system, wherein the sensors provide real-time data to the control module.

[0173] In some aspects, the techniques described herein relate to a CSF shunt control system, wherein the shunt is configured to be remotely adjusted by a healthcare provider via an interface with the control module.

[0174] In some aspects, the techniques described herein relate to a CSF shunt control system, wherein the predetermined parameters compise at least one of: pressure, flow rate, and / or CSF composition.

[0175] In some aspects, the techniques described herein relate to a CSF shunt control system, wherein the sensors are configured to monitor at least one of the predetermined parameters.

[0176] A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made. For example, advantageous results may be achieved if the steps of the disclosed techniques were performed in a different sequence, or if components of the disclosed systems were combined in a different manner, or if the components were supplemented with other components. Accordingly, other implementations are contemplated within the scope of the following claims.

Claims

CLAIMS1. A skeletal body adjustment device comprising: a first body configured to be coupled within a first skeletal body; a second body configured to be coupled within a second skeletal body, the first body telescopically connected to the second body; at least one control member coupled to the first expanding body and the second expanding body such that operating the at least one control member telescopically translates at least one of the first body and the second body relative to each other such that corresponding motion is induced of at least one of the first skeletal body and the second skeletal body relative to each other.

2. The skeletal body adjustment device of claim 1, wherein at least one of the first body and the second body are expandable.

3. The skeletal body adjustment device of claim 2, wherein the at least one of the first body and the second body comprises an expandable stent.

4. The skeletal body adjustment device of any one of claims 1-3, further comprising: an anchor coupled to at least one of the first body and the second body, the anchor configured to couple to the at least one of the first body and the second body to a corresponding at least one skeletal body of the first skeletal body and the second skeletal body.

5. The skeletal body adjustment device of claim 4, wherein the anchor is selectively operably from at least a stowage mode to a deployed mode, the deployed mode corresponding to coupling to the corresponding at least one skeletal body.

6. The skeletal body adjustment device of claim 5, wherein the anchor is selectively operable from the deployed mode to the stowage mode, the stowage mode corresponding to decoupling from the corresponding at least one skeletal body.

7. The skeletal body adjustment device of any one of claims 1-6, further comprising a sensor coupled to at least one of the first body and the second body.

8. The skeletal body adjustment device of claim 7, wherein the sensor comprises at least one conductive lead coupled to and / or integrated into the anchor.

9. The skeletal body adjustment device of any one of claims 1-8, further comprising a controller operably coupled to selectively operate the at least one control member.

10. The skeletal body adjustment device of claim 9, wherein the controller is operably coupled to a sensor coupled to at least one of the first body and the second body.

11. The skeletal body adjustment device of claim 10, wherein the controller selectively operates the at least one control member based on input from at least one sensor.

12. The skeletal body adjustment device of any of claims 1-11, further comprising a delivery mechanism.

13. The skeletal body adjustment device of claim 12, wherein the delivery mechanism comprises a conductive lead coupled to and / or integrated into the anchor.

14. The skeletal body adjustment device of any of claims 8 and 13, wherein the conductive lead is optically conductive.

15. The skeletal body adjustment device of any of claims 8 and 13-14, wherein the conductive lead is electrically conductive.

16. The skeletal body adjustment device of any of claims 4-15, further comprising at least a second of said anchor.

17. The skeletal body adjustment device of any of claims 1-16, wherein: the first body comprises a first lumen, the second body comprises a second lumen, and the first lumen is in fluid communication with the second lumen.

18. A method of adjusting vertebral bodies, the method comprising: create an access into a first vertebral body via a pedicle of the first vertebral body; create an access into a second vertebral body via a pedicle of the second vertebral body; dispose a skeletal body adjustment device of any of claims 1-16 such that the first body is disposed within the first vertebral body, and the second body is disposed within the second vertebral body; couple the first body to the first vertebral body; couple the second body to the second vertebral body; and, operate the control member such that at least one of the first body and the second body are displaced relative to each other such that corresponding displacement is induced in at least one of the first vertebral body and the second vertebral body.

19. The method of claim 18, wherein operating the control member comprises operating a tether.

20. The method of any one of claims 18-19, wherein the displacement of the at least one of the first body and the second body comprises telescopic extension of the skeletal body adjustment device, and the corresponding displacement of the at least one of the first skeletal body and the second skeletal body comprises extension of the spinal column.

21. The method of any one of claims 18-20, further comprising operating at least one anchor into a deployed mode such that at least one of the first body and the second body are coupled to a corresponding at least one of the first skeletal body and the second skeletal body.

22. The method of any one of claims 18-21, further comprising advancing a catheter through a lumen of the skeletal body adjustment device.

23. The method of any one of claims 18-22, further comprising advancing a lead through and / or from the skeletal body adjustment device and into proximity to nerve tissue such that the lead is configured to monitor and / or stimulate the nerve tissue.

24. A body cavity engagement device comprising: an expandable stent configured to conform to a body cavity in an expanded configuration; a plurality of contact modules extending at least partially to an exterior of the expandable stent, the plurality of contact modules configured to contact tissue defining the body cavity and configured to communicably couple to a controller.

25. The body cavity engagement device of claim 24, wherein the expandable stent is configured to be disposed in a ventricle of a human brain.

26. The body cavity engagement device of claim 25, wherein the expandable stent comprises a three-dimensionally oval shape of the exterior.

27. The body cavity engagement device of any one of claims 24-26, wherein at least one of the contact modules comprises a sensor.

28. The body cavity engagement device of any one of claims 24-27, wherein at least one of the contact modules comprises a conductive lead.

29. The body cavity engagement device of claim 28, wherein the conductive lead is configured to selectively communicate electrical energy.

30. The body cavity engagement device of claim 28, wherein the conductive lead is configured to selectively communicate optical energy.

31. The body cavity engagement device of any one of claims 24-30, wherein at least one of the contact modules is configured as an anchor.

32. The body cavity engagement device of any one of claims 24-31, wherein at least one of the contact modules is selectively deployable in response to a signal from the controller.

33. The body cavity engagement device of claim 32, wherein a plurality of the contact modules are individually selectively deployable.

34. The body cavity engagement device of any one of claims 24-32, further comprising a therapeutic agent impregnated in the stent.

35. The body cavity engagement device of any one of claims 24-34, configured as a braincomputer interface.

36. The body cavity engagement device of any one of claims 24-35, configured and / or operated to treat at least one epilepsy, depression, and Parkinson’s disease.

37. A bladder comprising: a fluid permeable outer layer defining a first chamber; an impermeable inner layer disposed within the outer wall and defining both a second chamber between the outer layer and the inner layer and a third chamber within the inner layer; a conduit defining a lumen and disposed within the inner wall and in fluid communication with the third chamber and an exterior of the outer layer; and, at least one control member configured to selectively operate the outer layer and / or the inner layer between a plurality of spatial configurations.

38. The bladder of claim 37, wherein: a first of the plurality of spatial configurations comprises a stowage mode in which the outer layer and the inner layer are collapsed along the conduit, a second of the plurality of spatial configurations comprises a deployed mode in which the outer layer and the inner layer are inflated.

39. The bladder of claim 38, wherein the at least one control member is configured to operate at least the outer layer from the deployed mode to the stowage mode.

40. The bladder of any one of claims 38-39, wherein operating at least one of the outer layer and the inner layer from the stowage mode to the deployed mode comprises providing a fluid such that the at least one of the outer layer and the inner layer are inflated.

41. A neurosurgery method comprising: provide the bladder of any one of claims 37-40 in a stowage mode; introduce the bladder into a neural tissue cavity; inflate the bladder into a first deployed mode having a first size; and, operate the at least one control member of the bladder to operate the bladder into a second deployed mode having a second size.

42. The method of claim 41, further comprising: introduce fluid into the first cavity such that at least a portion of an exterior surface of the outer layer is flushed.

43. The method of any one of claims 40-42, further comprising: retrieve fluid from the body cavity via the lumen.

44. The method of any one of claims 40-43, wherein the neural tissue cavity comprises a brain ventricle.

45. A cerebrospinal fluid (CSF) shunt system comprising: a shunt configured to be implanted in a patient's body in fluid communication with CSF; sensors operably coupled to the shunt; a control module operatively connected to the sensors, the control module configured to adjust the operation of the shunt based on a at least one predetermined parameter; and, valves operatively connected to the control module and selectively operable by the control modules such that CSF flow is dynamically regulated.

46. The CSF shunt system of claim 45, further comprising: a pump operatively connected to the shunt, the pump configured to deliver therapeutic agents through the shunt.

47. The CSF shunt system of any one of claims 45-46, wherein the control module is configured to adjust the operation of the shunt remotely.

48. The CSF shunt system of any one of claims 45-47, wherein the sensors provide real-time data to the control module.

49. The CSF shunt control system of any one of claims 45-48, wherein the shunt is configured to be remotely adjusted by a healthcare provider via an interface with the control module.

50. The CSF shunt control system of any one of claims 45-49, wherein the predetermined parameters compise at least one of: pressure, flow rate, and / or CSF composition.

51. The CSF shunt control system of any one of claims 45-50, wherein the sensors are configured to monitor at least one of the predetermined parameters.

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