Spinal and neurosurgical devices

Abstract

In some embodiments, devices and related methods involve a skeletal body adjustment device (SBAD) having telescopically connected bodies. For example, the SBAD can include a control member configured to cause relative translation between the bodies. In some embodiments, devices and related methods involve a body lumen compliant shunt. As an illustrative example, the shunt may, for example, include a selectively deployable contact member. By way of example and not limitation, the contact member can be configured as an anchor, a sensor, and / or a therapy delivery device. In some embodiments, devices and related methods involve a multi-layer balloon (MLB) that can be selectively deployed in a body lumen. The MLB may, for example, include a sensing and / or delivery assembly. The MLB may, for example, include a control member and / or a pressure controller configured to control a shape, size, and / or pressure of the MLB. In some embodiments, devices and related methods involve a dynamically controlled cerebrospinal fluid (CSF) shunting system.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 590,313 entitled “Neurosurgical Devices and Methods”, filed October 13, 2023, by Samuel Robert Browd et al.

[0003] The subject matter of this application may share cataloging information with and / or may be related to the following subjects:

[0004] • U.S. Patent Application Serial No. 18 / 313,249, entitled “Dynamically Controlled Cerebrospinal Fluid Shunt”, filed on May 5, 2023 by Samuel Robert Browd et al.

[0005] • U.S. Application Serial No. 63 / 365,407, entitled “Distributed Sensing and Control of Cerebrospinal Fluid”, filed on May 26, 2022 by Samuel Robert Browd et al.

[0006] • U.S. Application Serial No. 63 / 477,158, entitled “Central Nervous System Monitoring and Intervention”, filed on December 23, 2022 by Samuel Robert Browd et al.

[0007] • U.S. Application Serial No. 63 / 477,162, entitled “Cerebrospinal Fluid Polarization”, filed on December 23, 2022 by Samuel Robert Browd et al.

[0008] • U.S. Application Serial No. 63 / 488,412, entitled “Dynamic Diversion System”, filed on March 3, 2023, by Samuel Robert Browd et al.

[0009] • U.S. Application Serial No. 63 / 364,253, filed May 5, 2022, by Samuel Robert Brown, entitled “Potential for Offloading Technology and Intelligent Offloading”; and

[0010] • U.S. Application Serial No. 63 / 590,191, entitled “Dynamically Guided Physician-Patient Interaction Engine”, filed on October 13, 2023 by Samuel Robert Browd et al.

[0011] This application incorporates the entire contents of the foregoing application and all applications claiming priority and / or benefits herein. Technical Field

[0012] The various embodiments generally relate to medical devices and / or methods. Background Technology

[0013] The ventricular system and / or cerebrospinal fluid (CSF) of the brain may play a vital role in maintaining the overall health of the central nervous system. Various diseases and disorders can affect these systems, leading to significant neurological complications. For example, hydrocephalus is characterized by the abnormal accumulation of CSF in the ventricles. This excess fluid causes increased intracranial pressure, resulting in symptoms such as headache, vomiting, blurred vision, and cognitive impairment. Treatment typically involves surgically implanting a shunt to divert the fluid to another part of the body.

[0014] Chiari malformation occurs when brain tissue protrudes into the spinal canal, often affecting the flow of cerebrospinal fluid (CSF). This can cause symptoms such as headache, 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 that cover the brain and spinal cord, usually caused by infection. This condition disrupts the normal flow and composition of CSF. Symptoms include severe headache, fever, neck stiffness, and light sensitivity. Treatment typically involves antibiotics or antiviral medications. Normal pressure hydrocephalus is a form of hydrocephalus that commonly affects older adults. It is characterized by enlarged ventricles and normal CSF pressure. Symptoms include difficulty walking, urinary incontinence, and cognitive decline. Treatment usually involves inserting a shunt to relieve symptoms.

[0015] A pseudotumor of the brain, also known as idiopathic intracranial hypertension, is characterized by elevated intracranial pressure without a clear cause. Symptoms include severe headache, vision problems, and ringing in the ears. Treatment may involve medication to reduce CSF production or surgical intervention to relieve pressure. Subarachnoid hemorrhage may involve bleeding within the subarachnoid space that disrupts the circulation of cerebrospinal fluid. This condition is usually caused by a ruptured aneurysm and can lead to sudden, severe headache, nausea, and loss of consciousness. Immediate medical intervention is crucial, typically requiring surgical repair of the aneurysm and management of CSF pressure. Diseases and disorders affecting the ventricles and cerebrospinal fluid can have profound impacts on neurological function. Early diagnosis and appropriate treatment are essential for the effective management of these conditions and for improving patient outcomes.

[0016] The spine, commonly known as the vertebrae, plays a vital role in supporting the body's structure and protecting the spinal cord. Diseases and disorders affecting the spine can lead to severe pain, disability, and neurological complications. One common condition is intervertebral disc degeneration, which occurs when the intervertebral discs that cushion the vertebrae deteriorate over time, resulting in back pain, stiffness, and reduced mobility. Scoliosis, characterized by an abnormal curvature of the spine, can cause unevenness in the shoulders, lower back, and hips, and in severe cases, can impair lung and heart function. Another common condition is spinal stenosis, where the spinal canal narrows, compressing the spinal cord and nerves, leading to pain, numbness, and muscle weakness.

[0017] Other notable spinal conditions 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 spinal disc tears through a tear in its outer layer, compressing nearby nerves and causing pain, tingling, and weakness in the affected area. Vertebral fractures, often caused by osteoporosis or trauma, can lead to acute back pain and long-term spinal deformities. Additionally, conditions like ankylosing spondylitis, an inflammatory disease, can cause small bones in the spine to fuse, restricting movement and leading to a bent-over posture. Timely diagnosis and appropriate treatment are crucial for managing these conditions and improving patient outcomes. Summary of the Invention

[0018] In some embodiments, the apparatus and related methods relate to a skeletal body adjustment device (SB) having retractably connected bodies. For example, the SB AD may include control members configured to induce relative translation between the bodies. In some embodiments, the apparatus and related methods relate to a body cavity compliant shunt. As an illustrative example, the shunt may, for example, include selectively deployable contact members. By way of example and not limitation, the contact members may be configured as anchors, sensors, and / or therapeutic delivery devices. In some embodiments, the apparatus and related methods relate to a multilayer sac (MLB) selectively deployed in a body cavity. The MLB may, for example, include sensing and / or delivery components. The MLB may, for example, include control members and / or pressure controllers configured to control the shape, size, and / or pressure of the MLB. In some embodiments, the apparatus and related methods relate to a dynamically controlled cerebrospinal fluid (CSF) shunt system.

[0019] Various embodiments can achieve one or more advantages. For example, a vertebral access system (e.g., a skeleton body adjustment device (SBAD)) can be advantageously configured and / or operated for discectomy, fusion (e.g., posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), far lateral interbody fusion (XLIF)), collapsed / compressed discs, scoliosis intervention, foraminal compression, and / or supraosseous pain.

[0020] Some embodiments may advantageously provide, for example, a structural reinforcement module (e.g., SBAD) that is adjustable to, for example, advantageously reduce and / or increase the applied mechanical load, for example, based on a detected mechanical load curve.

[0021] Some embodiments may advantageously deliver one or more therapies, for example. Therapies may include, for example, pharmacological therapies, cell therapies, chemotherapy, bone stimulants, bone growth inhibitors, and / or biological therapies.

[0022] Some embodiments may advantageously provide electromagnetic stimulation via a stent and / or SBAD. For example, electromagnetic stimulation may advantageously be provided through a channel in the vertebral body (e.g., via SBAD).

[0023] Some embodiments may advantageously provide, for example, a scaffold that can be deployed into the ventricles or other cavities of the nervous system. For example, some embodiments may advantageously be conformally and / or custom-created for patient-specific cavity geometry. Some embodiments may advantageously provide, for example, a shunt configured for brain-computer interfaces (e.g., sensing, therapy).

[0024] Some embodiments may advantageously provide, for example, a capsule deployable into a body cavity (e.g., a ventricle or other nervous system cavity). For example, some embodiments may advantageously provide a conformal capsule configured to selectively apply pressure to a body cavity. For example, some embodiments may advantageously be used to treat bleeding (e.g., via packing, irrigation). Some embodiments may advantageously provide, for example, thermoregulation (e.g., via irrigation). Some embodiments may advantageously reduce adhesion to tissue and / or blood. Some embodiments may allow for adjustment of the pressure and / or geometry of the shunt and / or capsule.

[0025] Some embodiments may, for example, advantageously use sensors and control modules to dynamically control cerebrospinal fluid (CSF) flow. For example, some embodiments may advantageously provide a minimally invasive CSF shunt. Some embodiments may, for example, advantageously allow CSF flow to be remotely adjusted, for example, by a healthcare provider. In some embodiments, the CSF shunt may, for example, advantageously automatically adjust CSF flow by automatically adjusting the operation of the CSF shunt, for example, based on monitored parameters. Attached Figure Description

[0026] Figure 1 A schematic diagram of the vertebral entry system and associated methods is described.

[0027] Figure 2 and Figure 3 The structural reinforcement module is described.

[0028] Figure 4 Describing things such as using Figure 1 , Figure 2 and / or Figure 3 Deployment of intervertebral leads in systems, methods, and / or modules.

[0029] Figure 5 It depicts a schematic, body-aligned scaffold.

[0030] Figure 6 A schematic multilayered capsule is depicted.

[0031] Figure 7A schematic shunt is depicted that is configured to, for example, dynamically regulate the flow of cerebrospinal fluid (CSF).

[0032] Figure 8 A schematic method of vertebral entry is described.

[0033] Figure 9 and Figure 10 A schematic method related to structural reinforcement modules (such as skeleton body adjustment devices) is depicted.

[0034] Details of various embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the specification, the drawings, and the claims. Detailed Implementation

[0035] Figure 1 A schematic vertebral access system and associated methods are depicted. As shown, vertebra 105 has one or more processes, including transverse processes 110. Vertebra 105 includes one or more pedicles 115. The vertebral access system may, for example, include a steerable conduit 120. The steerable conduit may be operatively, communicatively, fluidly, mechanically, optically, and / or electrically coupled to one or more actuators, sensors, and / or interfaces (e.g., as shown). For example, an incision may be made to access the pedicle 115. A foramen may be formed in the pedicle 115. A passage may tunnel (movement 1A) from the foramen at the pedicle 115 to the vertebral body 116. For example, the vertebral body may include the spinal cord. The vertebral body may, for example, have few or no nerves. As shown, the spinal cord may be positioned in the vertebral foramen.

[0036] Once the tip of the steerable conduit 120 has reached the vertebral body (e.g., near the center of the vertebral body, as shown), the system can be operated such that the tip rotates substantially parallel to the spine and / or spinal cord 117 along axis 107 (illustrated as protruding beyond the page). For example, as shown, the tip can be steered toward or away from the spine. Figure 1 Viewers "leave the page".

[0037] As an example, and not a limitation, vertebral access systems and / or methods may be configured and / or operated for discectomy. Vertebral access systems and / or methods may, for example, be configured and / or operated for fusion (e.g., posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), far lateral interbody fusion (XLIF)). Vertebral access systems and / or methods may, for example, be configured and / or operated to dilate the intervertebral disc. Vertebral access systems and / or methods may, for example, be configured and / or operated for scoliosis intervention. Vertebral access systems and / or methods may, for example, be configured and / or operated for treating foramen compression. Vertebral access systems and / or methods may, for example, be configured and / or operated for relieving bone-on-bone pain.

[0038] The channels formed into and / or through the vertebral body (“tunneling”) can be reinforced and / or modified, for example. For instance, structural reinforcements can be deposited. In some embodiments, the structural reinforcements can be deposited freely (e.g., by extrusion of the reinforcing material). The reinforcing material can be activated, for example (e.g., by mixing components, by photopolymerization, by electrical stimulation, by thermal displacement).

[0039] As shown in the figure, in some embodiments, the system may include an endoscope 125 (e.g., as part of and / or operable with catheter 120).

[0040] In some embodiments, for example, the conduit 120 may be operatively coupled to an optical actuator. The optical actuator may, for example, be advantageously operated to provide phototherapy within the vertebra 105.

[0041] In some embodiments, the conduit 120 may be operatively (e.g., electrically) coupled to the electrical stimulation module 135. For example, it may be via... Figure 1 The routes shown provide electrical stimulation within the body (e.g., providing electrical stimulation to nerve tissue).

[0042] In some embodiments, catheter 120 may be operatively (e.g., fluidly) coupled to drug delivery module 140 (e.g., drug pump, biologic source). For example, drug therapy can be administered via catheter and / or through... Figure 1 The lumen provided by the indicated pathway is used for delivery within the body.

[0043] In some embodiments, other tools and / or modules (e.g., diagnostic tools, imaging tools, therapeutic tools) may be operatively coupled to catheter 120 and / or via, for example, Figure 1 The indicated routes are introduced into and / or connected to the body.

[0044] In some implementations, the structural reinforcement module can be delivered into the channel. For example, Figure 2 and Figure 3 A structural reinforcement module 210 (e.g., a skeleton body adjustment device) is depicted. For example, reinforcement module 210 may include stacked components. As shown, outer stacking elements 210 and inner stacking elements 211 may be "stacked" together (e.g., in an alternating order, as shown). Structural reinforcement module 210 and inner stacking elements 211 may be slidably (e.g., telescopically) coupled. For example, structural reinforcement module 210 may define one or more lumens (e.g., for subsequent access via channels, for delivering fluid, for delivering mechanical and / or electrical components).

[0045] The structural reinforcement module 210 may be delivered through and / or into a channel in a collapsed state (not shown). For example, the structural reinforcement module 210 may be folded downward along a longitudinal axis (e.g., opposite to motion 2B). Upon delivery to the target deployment location, the structural reinforcement module 210 may be expanded (e.g., motion 2B). By way of example and not limitation, expansion may be pneumatic and / or hydraulic (e.g., by airbags), thermal and / or electrical (e.g., shape memory alloys, shape memory polymers, including, for example, foam).

[0046] In some implementations, for example Figure 2 As shown, the structural reinforcement module 210 may be provided with an anchoring module 215. For example, the anchoring module 215 may be deployed after and / or during the expansion of the structural reinforcement module 210 into its deployment shape (e.g., movement 2A). In some embodiments, the anchoring module 215 may be, for example, pointed (e.g., as shown) and / or have a "pad" shape configured to engage (e.g., frictionally) surrounding tissue (e.g., as shown). Figure 2 (As shown by the dotted line in the upper left corner indicating "enlargement").

[0047] In some implementations, the structural reinforcement module 210 may selectively extend or retract (e.g., expand and / or contract) after anchoring to apply a targeted (e.g., three-dimensional) mechanical load to surrounding tissue. For example, if the structural reinforcement module 210 spans multiple vertebrae, it may extend further to longitudinally separate two vertebrae (e.g., “push them up” apart).

[0048] In some embodiments, the structural reinforcement module 210 may include, for example, an anchoring module 215 within the structural reinforcement module 210. For example, the structural reinforcement module 210 may be operated by a control member (e.g., telescopically). For example, the control member may include a tether 220 (e.g., flexible, rigid) that may be attached to the anchoring module 215 (e.g., internal, external), such as... Figure 3 As shown. In some embodiments, the tether 220 can be operated to apply tension between the two anchoring modules 215 (e.g., to push two of the structural reinforcement modules 210 toward each other). In some embodiments, one or more of the tethers 220 (e.g., operating as “pillars”) can be operated to apply a compressive force that forces the anchoring modules 215 apart (e.g., forces the structural reinforcement modules 210 apart). For example, a user can advantageously selectively operate the tethers 220 to anchor to selected anchoring modules 215 and apply selected forces to the selected anchoring modules 215 to achieve a desired shape (e.g., bending, straightening, compression, expansion) and / or mechanical load on the structural reinforcement modules 210.

[0049] In some embodiments, the control component may include screws and / or other inclined planes. In some embodiments, the control component may include a motor and / or other power source. In some embodiments, the control component may include a reel and / or cable.

[0050] In some embodiments, the control components (e.g., tether 220 as shown) may be adjustable. For example, a physician may re-approach the tether 220 and tighten or loosen them to apply incremental adjustments over time (e.g., in response to body growth and / or remodeling). In some embodiments, the tether 220 may be remotely adjustable. For example, the tether 220 may be coupled to a remote anchor point (e.g., accessible by a physician, such as inside and / or outside the body). For example, the tether 220 may be coupled to an actuator (e.g., a motor, a fluid pump). The actuator may be operated to adjust the tether 220. For example, a physician and / or control module may operate the actuator to achieve a target (e.g., predetermined) geometry, position, and / or mechanical load. In some embodiments, mechanical adjustment may be performed, for example, by a microelectromechanical system (MEMS). In some embodiments, mechanical adjustment may be performed by a magnetic rowing bar, by way of example and not limitation. For example, vertebral mechanical loads may be advantageously applied to displacement, elevation, and / or straightening components of the spine.

[0051] In some implementations, mechanical adjustment parameters may be provided. For example, resistance to sliding and / or rotation of mechanical joints in and / or between components of the structural reinforcement module 210 may be provided. Extension adjustments may be provided, for example. Adjustments may be made statically during implantation. For example, adjustments may be made dynamically after implantation (e.g., over hours, days, weeks, months, years).

[0052] In some implementations, adjustments may be made in response to parameters detected in the surrounding physiology. For example, pressure and / or force (e.g., strain, shear) sensors may be placed and operated to detect mechanical loads on surrounding tissues (e.g., bone, muscle). Sensors may be configured, for example, to detect bone growth. Sensors may include, for example, conductivity sensors. Sensors may include, for example, position, orientation, and / or motion sensors. Sensors may include, for example, analyte detectors (e.g., lab-on-a-chip).

[0053] In some implementations, treatment delivery can be performed in response to (e.g., manually, automatically) data collected from the sensors disclosed herein. For example, a notification can be generated based on a signal crossing a predetermined threshold. For example, a control signal can be generated based on a signal crossing a predetermined threshold. In some implementations, for example, drugs, cells, growth factors, electrical stimulation, phototherapy, and / or mechanical adjustments can be delivered in response to local and / or remote sensors. For example, pharmacological treatments can be advantageously timed to correspond to specific events and / or circadian rhythm cycles detected by sensors. For example, mechanical loading can be advantageously timed to correspond to specific detected events and / or circadian rhythm cycles. In some implementations, for example, events and / or circadian rhythm cycles can be personalized for the patient (e.g., through machine learning models).

[0054] The structural reinforcement module 210 can, for example, be adjusted to reduce and / or increase the mechanical load applied based on the detected distribution of mechanical load. For example, such embodiments can be advantageously operated (e.g., manually, automatically). Such embodiments can, for example, advantageously reduce disease in adjacent body parts and / or segments (e.g., by dynamically adapting to reduce excessive mechanical load applied to surrounding tissues).

[0055] For example, the structural reinforcement module 210 can be configured as an expandable scaffold (e.g., a "cage"). The structural reinforcement module 210 can be impregnated, for example, with one or more active ingredients (e.g., a drug-eluting scaffold). The structural reinforcement module 210 can be provided with a delivery mechanism (e.g., a tube, fluid passage, valve) for therapeutic delivery. Therapeutic agent delivery can, for example, include pharmacological therapy. Therapeutic agent delivery can, for example, include cell therapy. Therapeutic agent delivery can, for example, include chemotherapy (e.g., topical chemotherapy). Therapeutic delivery can, for example, include bone stimulants. Therapeutic delivery can, for example, include bone growth inhibitors. Therapeutic agent delivery can, for example, include biological agents.

[0056] In some embodiments, the therapy can be delivered by means of a mechanism other than and / or attached to the structural reinforcement module 210 (e.g., via a catheter, a pump). For example, in some embodiments, the above method can be performed without inserting a structural reinforcement.

[0057] In some implementations, electromagnetic stimulation can be provided (e.g., through channels in the vertebral body, integrated into and / or deployed via the structural enhancement module). For example, leads can be positioned near the spinal cord. For example, leads can be positioned near branch nerves. Leads can, for example, be positioned near cerebrospinal fluid (CSF). Leads can, for example, include electrical leads (e.g., electrical conductors). Leads can, for example, include optical transmission leads (e.g., fiber optic cables). For example, a stimulation source (e.g., a light source, a power source) can be selectively operated to apply localized electromagnetic stimulation (e.g., electrical stimulation, phototherapy).

[0058] In some implementations, such as Figure 4 As shown, stimulation can be applied to the nerve 410 detached from the vertebra 105. For example, an intervertebral guide 415 may be positioned adjacent to and / or in contact with the nerve 410. The intervertebral guide 415 may, for example, be manipulated to sense and / or stimulate the nerve 410. The intervertebral guide 415 may, for example, terminate at one or more terminal modules 420 (e.g., sensors, stimulators).

[0059] In some implementations, by way of example and not limitation, the intervertebral lead 415 may be connected to a generator 425 (e.g., an electrical generator, a light generator, a chemical pump). The intervertebral lead 415 may, for example, be coupled (e.g., communicatively) to one or more sensors and / or control modules 430 disposed in other parts of the body (e.g., cortical sensors, such as those including electroencephalogram (EEG) monitoring devices).

[0060] Figure 5 A schematic, body-conforming scaffold is depicted. In some embodiments, the scaffold 505 can be deployed into a body cavity. For example, the scaffold 505 can be configured for a nervous system cavity. By way of example and not limitation, the scaffold 505 can be configured for a ventricle (e.g., the frontal ventricle). For example, the scaffold 505 can be delivered, for example, via open cortical resection. The scaffold 505 can be delivered, for example, via endoscopy.

[0061] In the depicted example, stent 505 can be deployed, for example, via catheter 510 (e.g., a steerable catheter, endoscope). Stent 505 can be expanded, for example, via balloon 515. Stent 505 can be connected (e.g., fluid connection) to shunt 525 (e.g., a hydrocephalus shunt). Stent 505 can be connected to and / or provided with one or more sensors and / or actuators 520. For example, as shown, controller 530 can be operatively coupled to one or more sensors and / or actuators.

[0062] The body 540 of the scaffold 505 may, for example, be shaped to fit the ventricle. The scaffold 505 may, for example, have expandable members 545. The expandable members 545 may expand (e.g., move 506) before, during, and / or after the body 540 expands from a delivery state (e.g., collapsed) to a deployment state (e.g., expanded). The expandable members 545 may, for example, be used to provide mechanical and / or communicative (e.g., electrical) contact with surrounding body tissue (e.g., the ventricular wall). One or more of the expandable members 545 may, for example, be provided with contact modules 550. For example, contact modules 550 may include mechanical anchors (e.g., pads, microneedles). For example, contact modules 550 may include electrical contacts (e.g., conductive pads). For example, contact modules 550 may include actuators (e.g., LEDs) and / or sensors (e.g., force / pressure sensors, lab-on-a-chip, EEG electrodes, fluid flow sensors, CSF analyte sensors).

[0063] The stent 505 may be impregnated and / or coated, for example, with a therapeutic agent (e.g., a pharmacological agent). For example, a pump 535 may deliver the therapeutic agent through the stent 505 (e.g., in response to a controller 530).

[0064] The deployment of stent 505 can be controlled, for example, based on sensors (e.g., in contact module 550). In some embodiments, by way of example and not limitation, body 540 may include multiple selectively deployable segments. These segments can be controlled and / or deployed independently, for example. For example, a multi-segment arrangement can advantageously allow stent 505 to be customized to fit a particular patient and / or cavity.

[0065] Some embodiments may be configured, for example, to provide a brain-computer interface. For example, electrodes on scaffold 505 may expand and / or conform to the ventricles. Some embodiments may, for example, deliver current and / or apply voltage (e.g., multifocal potential) to the ventricles and / or CSF. In some embodiments, some electrodes may be configured as anodes, and some electrodes may, for example, be configured as cathodes (e.g., for potential "switching").

[0066] Some embodiments may be advantageously configured and / or operated, for example, to treat epilepsy. Some embodiments may be advantageously configured and / or operated, for example, to treat depression (e.g., chronic). Some embodiments may be advantageously configured and / or operated, for example, to treat obsessive-compulsive disorder. Some embodiments may be advantageously configured and / or operated, for example, to treat Parkinson's disease. Some embodiments may be advantageously configured and / or operated, for example, to provide deep brain stimulation. Some embodiments may be advantageously configured and / or operated, for example, to provide local drug delivery. Some embodiments may be advantageously configured and / or operated, for example, to provide photocatalytic effects.

[0067] Some embodiments may advantageously provide multiple modalities, for example. For instance, some embodiments may synchronize treatments (e.g., light delivery, electrical stimulation, drug delivery, mechanical loading). For example, treatments may be synchronized with each other, with transient events, and / or with biological rhythms. Synchronization may, for example, be predetermined. Synchronization may, for example, be personalized. For example, drug delivery may be timed to achieve maximum effect with minimum dosage (e.g., after electrical stimulation, during light stimulation, after a detected event and / or threshold).

[0068] In some embodiments, by way of example and not limitation, a hydrocephalus shunt (e.g., as at least with reference to what is disclosed) may be configured with backflow. For example, backflow may be generated based on pulsed backflow.

[0069] Figure 6 A schematic sac 605 is depicted. The sac 605 may, for example, be selectively deployed within a body cavity. For example, a body cavity 620 may be within neural tissue. For example, a body cavity 620 may be a ventricle in a patient's brain. The operation may, for example, have already been performed within the body cavity 620. In some examples, the body cavity 620 may have been created by surgery (e.g., removal of a portion of tissue). Surrounding tissue may be perfused by a vascular system 625 (e.g., a blood vessel). The vascular system 625 may, for example, drain into the body cavity 620 in response to an intervention (e.g., surgery).

[0070] Sac 605 may be configured, for example, to conform to at least some of the body cavities 620. For example, sac 605 may be configured as a deployable sac. Sac 605 may be, for example, multi-segmented. For example, sac 605 may include a stent (e.g., stent 505).

[0071] As an illustrative example, such as in Figure 6 As depicted, sac 605 may be provided with an outer layer 610 and an inner layer 615. The inner layer 615 may, for example, be highly flexible. For example, the inner layer 615 may conform to the shape of the body cavity 620 under environmental pressure (e.g., ambient pressure, normal pressure within the body cavity 620).

[0072] The outer layer 610 may be, for example, highly compliant. For example, the outer layer 610 may conform to the shape of the body cavity 620 under environmental pressure (e.g., environmental pressure, normal pressure within the body cavity 620).

[0073] The outer layer 610 may be, for example, fluid-permeable. For example, the outer layer 610 may include pores and / or windows. In some embodiments, the outer layer 610 may be, for example, porous. For example, the outer layer 610 may be water-permeable. For example, the outer layer 610 may be saline-permeable.

[0074] The inner layer 615 may be fluid-tight (e.g., watertight, airtight). Separate (e.g., independent) fluid conduits may lead to the catheter controller 655. For example, the catheter controller 655 may include a handle. The catheter controller 655 may include a human-machine interface (e.g., a knob; a lever; a touchscreen; feedback mechanisms such as haptic, audio, or visual). The catheter controller 655 may include, for example, an automatic control module. For example, the catheter controller 655 may communicate with sensors (not shown). Sensors may be disposed, for example, within, on, and / or around the capsule 605. In some embodiments, the sensor 660 may be disposed, for example, remotely from the capsule 605 (e.g., an EEG lead, analyte monitor, heart rate monitor, oxygenation monitor).

[0075] By way of example and not limitation, the inner layer 615 may define the inner bladder 645 as depicted. The inner bladder 645 may be fluid-tight (e.g., water-tight, air-tight). The volume and / or pressure of the fluid in the inner bladder 645 may be selectively controlled, for example (e.g., by means of a pump 670 fluidly coupled to the inner bladder 645, shown in this example as operably coupled to 655) to selectively inflate / deflate the inner bladder 645.

[0076] The outer layer 610 may define (e.g., in cooperation with the inner layer 615) an external volume 650. The external volume 650 may be fluid-permeable, for example, on an outer surface. The external volume 650 may be fluidly coupled to a fluid source (e.g., a pump 670). For example, the external volume 650 may be selectively fluidly coupled to the pump 670 by operation of a conduit controller 655 (e.g., operation of one or more valves, not shown).

[0077] In the illustrated example, by way of example and not limitation, bladder 605 is provided with a fluid passage 630. As illustrated, the fluid passage 630 is provided with an orifice 635 (e.g., one or more orifices) for access to inner bladder 645. For example, the fluid passage 630 may be selectively fluid-coupled (e.g., via a valve, not shown) to inner bladder 645.

[0078] As depicted, the fluid passage 630 is provided with orifices 640 (e.g., one or more orifices) to the outer surface of the sac 605. For example, the fluid passage 630 may be selectively fluid-coupled (e.g., via a valve, not shown) to the body cavity 620.

[0079] In some examples, fluid passage 630 may be provided with one or more orifices (not shown) leading to external volume 650. For example, fluid passage 630 may be selectively fluid-coupled (e.g., via a valve, not shown) to external volume 650.

[0080] In the illustrative operating method, sac 605 can be operated in a deployed state. For example, sac 605 can collapse about a longitudinal axis (e.g., fluid channel 630). For example, sac 605 can collapse in the deployed state to be operated into body cavity 620 (e.g., in a minimally invasive manner).

[0081] Once the sac 605 is within the body cavity 620, the sac 605 can be operated into a deployed state. For example, the inner sac 645 can inflate (e.g., by filling with fluid and / or pressurizing with fluid). One or more sensors 660 can, for example, monitor one or more properties. Sensor 660 can, for example, monitor temperature. For example, sensor 660 can monitor continuity. For example, sensor 660 can monitor electrical conductivity. For example, sensor 660 can monitor resistance. Sensor 660 can, for example, monitor pressure. Sensor 660 can, for example, monitor strain. For example, sensor 660 can monitor compliance. Sensor 660 can, for example, monitor contact. Sensor 660 can, for example, monitor distance. For example, sensor 660 can monitor motion. For example, sensor 660 can monitor orientation.

[0082] For example, the inner capsule 645 can be inflated until a target pressure threshold is reached. As an illustrative example, after surgery, the vascular system 625 may be bleeding into the body cavity 620. The inner capsule 645 can be inflated (e.g., via fluid channel 630) until the capsule 605 pressurizes against the surface of the body cavity 620 (e.g., against brain tissue). For example, the capsule 605 can be effectively used to fill the surface of the body cavity 620. Pressure can, for example, slow or stop bleeding from the vascular system 625.

[0083] Sac 605 can be pressurized for a period of time (e.g., minutes, hours, days, or more). In some examples, sac 605 can be pressurized for 1–5 days (e.g., 1–3 days). The pressure, volume, and / or shape of sac 605 can be adjusted, for example, over time. For example, sac 605 can be adjusted based on feedback from one or more sensors 660. For example, sac 605 can be slowly depressurized over several days to allow tissue remodeling and / or healing. Once bleeding has stopped, for example, sac 605 can collapse and be removed.

[0084] In some examples, the capsule 605 may be provided with a non-stick coating. For example, the outer layer 610 may resist adhesion of brain tissue and / or blood.

[0085] In some examples, sac 605 may be flushed. For example, the outer surface of sac 605 may be flushed. Flushing may, for example, advantageously reduce the adhesion of tissue and / or blood to sac 605. In the depicted example, the outer volume 650 may, for example, be supplied with fluid. The fluid may, for example, include physiological saline. The outer layer 610 may, for example, be fluid-permeable.

[0086] Flushing can be performed, for example, periodically. Flushing can be performed, for example, continuously. Flushing can be performed, for example, on demand. In some embodiments, additives can be delivered via flushing. For example, therapeutic agents such as drugs (e.g., clotting factors, chemotherapeutic agents, antibiotics) can be delivered via flushing and / or through the outer layer 610 and the inner capsule 645.

[0087] As an illustrative example, the filling of the external volume 650 can be synchronized with the reduction of the volume of the internal capsule 645. Such an embodiment can, for example, advantageously avoid excessive pressure on the body cavity 620.

[0088] By way of example and not limitation, some embodiments may oscillate the pressure and / or volume of sac 605. For example, oscillating pressure and / or volume may cause oscillations in the size of sac 605. Oscillations may, for example, release the "adhesion" of sac 605 to tissue and / or blood. Oscillations may, for example, be caused by pulsation of fluid in the inner sac 645 and / or the outer volume 650.

[0089] As an illustrative example, when sac 605 is to be removed, the inner sac 645 can be reduced in volume (e.g., via orifice 635 and fluid channel 630). The outer volume 650 can be pressurized such that at least a portion of the outer surface of sac 605 is flushed (e.g., via outer layer 610). By way of example and not limitation, flushing can be performed for several minutes. Flushing can, for example, be performed for several hours (e.g., several hours). The pressure exerted on the tissue by sac 605 can be reduced (e.g., gradually reduced over several hours or days). Once sac 605 no longer exerts substantial pressure on the tissue in body cavity 620, sac 605 can be completely deflated (e.g., via fluid channel 630). Rope 665 can, for example, be disposed in and / or around one or more layers (e.g., outer layer 610, inner layer 615). Rope 665 can, for example, be pulled to constrain sac 605 into a shape suitable for retraction (e.g., collapse along the longitudinal axis, such as rather than bundled / stuffed).

[0090] In some examples, the internal struts and / or tethers 675 may, for example, constrain the geometry of the bladder 605. For example, the struts and / or tethers may prevent the bladder 605 from spherizing or becoming bloated. For example, the tethers 675 may constrain the bladder 605 into a longitudinally extending shape upon collapse. In some examples, the tethers 675 may, for example, be elastic (e.g., stretchable when the bladder 605 is pressurized and returns to substantially the same length when the pressure is released).

[0091] One or more of the sensors 660 can, for example, monitor bleeding. For example, an analyte sensor can monitor the presence of blood and / or bleeding-related components (e.g., hemoglobin). For example, an optical sensor can monitor the color of fresh blood. For example, a temperature sensor can monitor temperature changes corresponding to bleeding. For example, a conductivity sensor, a resistance sensor, and / or a capacitance sensor can monitor changes in conductivity, resistance, and / or capacitance corresponding to the presence of fresh blood. In response to the detection of blood, the contraction and / or expansion of the sac 605 can be adjusted and / or a therapeutic agent can be delivered.

[0092] In some examples, sac 605 can be operated to flush body cavity 620 with a thermally disintegrating fluid (e.g., via a pump such as pump 670). For example, body cavity 620 can be flushed with a cooler fluid to cool body cavity 620 and / or surrounding tissues. For example, body cavity 620 can be flushed with a hotter fluid to warm body cavity 620 and / or surrounding tissues.

[0093] In some examples, bladder 605 can operate as a heat source and / or a heat dissipation device. For example, fluid can circulate in the inner bladder 645 and / or the outer volume 650. For example, the outer layer 610 and / or the connection structure to the inner layer 615 can be thermally conductive (e.g., metal, graphene, carbon). The inner bladder 645 can be operated, for example, as a fluid radiator and / or a heat exchanger. Fluid can be circulated to introduce a cooler fluid (e.g., with or without flushing). Such examples can be configured and / or operated, for example, to cool body cavity 620 and / or surrounding tissues.

[0094] In some examples, the capsule 605 may be fluidly coupled to a heat source (e.g., a heater) and / or a radiator (e.g., for a cooling unit). The heat source and / or radiator may be, for example, remote (e.g., external to the body). In some examples, the heat source and / or radiator may be disposed on and / or within the body (e.g., an implant). For example, fluid may circulate (e.g., via an internal pump) through / across the radiator, which is thermally coupled to a cooler part of the body (e.g., the patient's outer surface, such as in an air-conditioned environment).

[0095] In some examples, the sac 645 can be operated as a fluid heat source. Fluid can be circulated to introduce hotter fluid. Such examples can be configured and / or operated, for example, to heat the body cavity 620 and / or surrounding tissues.

[0096] In some cases, cooling brain tissue to as little as 2-3°F can reduce or cure epilepsy.

[0097] Sac 605 can, for example, be configured and / or operated for the treatment of brain injury. Sac 605 can, for example, be configured and / or operated for the treatment of epilepsy. Sac 605 can, for example, be configured and / or operated for the treatment of meningitis. Sac 605 can, for example, be configured and / or operated for the treatment of neuroinflammatory diseases. Sac 605 can, for example, be configured and / or operated for the treatment of Alzheimer's disease.

[0098] In some embodiments, such as those depicted, sealing members 680 and / or 685 may be provided. For example, the sealing members may be configured as single or multiple (e.g., nested) collars. The sealing members may seal against, for example, a fluid passage 630 (e.g., a conduit). For example, the collars may slide relative to each other. In some embodiments, such as those shown, a control member (e.g., a rope 665) may be configured to be operated, for example, via the sealing members.

[0099] Figure 7 A schematic shunt 705 is depicted. For example, shunt 705 can be configured and / or operated as a brain shunt (as depicted). Shunt 705 can, for example, be configured and / or operated as a hydrocephalus shunt. In the depicted example, shunt 705 is implanted, for example, through the patient's skull 701 into the patient's brain 702 (e.g., fluidly coupled to a body cavity 620, such as the frontal ventricle). In the depicted instance, shunt 705 is coupled to a controller 745 (e.g., which may include and / or be coupled to a catheter controller 655). Shunt 705 can, for example, be fluidly coupled to a pump 750. As shown, pump 750 is operatively coupled to controller 745.

[0100] In some embodiments, such as shown, a diverter 705 terminates in a body cavity 620. The diverter 705 may be provided with an orifice 710 (e.g., at a distal end within the body cavity 620). Fluid in the body cavity 620 may enter the diverter 705, for example, through the orifice 710. The fluid may be processed, for example, via the diverter 705 (e.g., via a pump 750).

[0101] In some examples, tissue (e.g., brain tissue) may grow onto and / or anchor to shunt 705. For example, tissue may grow to at least partially block orifice 710. Some embodiments may, for example, backflush to drain fluid 720 through orifice 710. Backflush may be performed automatically, for example (e.g., in response to a signal from controller 745).

[0102] In some implementations, backflush can be controlled according to a relationship such as that shown in curve 725. For example, backflush can be operated within a specific time and / or volume based on the amount of fluid discharged from body cavity 620 through diverter 705. For example, one or more sensors 740 can monitor fluid flow rate and / or pressure (e.g., intracranial pressure). A predetermined ratio (e.g., a ratio range) can be set for the allocated volume (V_D) to the backflush volume (V_B). As an illustrative example, but not limited to, backflush can be operated according to a 2:1 ratio of V_D:V_B. For example, controller 745 can operate valves and / or pump 750 to backflush periodically based on V_D and / or V_B.

[0103] In some implementations, the backflush can be pulsed. For example, controller 745 can operate valves and / or pump 750 to pulse fluid (e.g., at a pressure that is momentarily increased relative to the normal pressure in the brain) and / or oscillate fluid (e.g., momentary pressure is ejected from shunt 705 and then drawn into shunt 705).

[0104] In some examples, the backwash relationship can be adjustable (e.g., by a physician). The backwash relationship can be learned, for example (e.g., based on patient pressure and / or fluid flow data). For example, the backwash relationship can be increased to increase backwash when static pressure increases and / or distribution flow (Q_D) decreases. Increased backwash can advantageously reduce blockage, for example.

[0105] In some implementations, by way of example and not limitation, multiple channels can be operated to cooperate in flushing the surface of the shunt 705. For example, fluid can be dispensed from some orifices 710, and suction can be applied to corresponding (e.g., adjacent) orifices 710. For example, simultaneous coordinated dispensing and suction can cause fluid to flow across the surface of the shunt 705. For example, flushing can advantageously cause a locally elevated fluid flow sufficient to disrupt tissue anchored to the shunt 705. The locally elevated fluid flow can, for example, prevent or reduce damage to surrounding brain tissue.

[0106] In some implementations, for example, the shunt 705 may be pulsed. For example, the shunt 705 may momentarily operate to an expanded state 705E (e.g., motion 715) before returning (e.g., actively, elastically) to a normal state (e.g., motion 715). Pulsation can, for example, advantageously disrupt the anchorage of unwanted tissue on the shunt 705.

[0107] In some examples, the actuator may be positioned on or near the surface of the shunt 705 and / or in or near the orifice 710. For example, the actuator 755 may include an ultrasonic transmitter. The actuator 755 may be operated (e.g., periodically) to disrupt the growth and / or anchoring of unwanted tissue. The actuator 755 may advantageously prevent blockage of the orifice 710, for example.

[0108] In some examples, actuator 755 may include an electro-electrifier. For example, the electro-electrifier may induce a low level of current in shunt 705 itself. The current may advantageously suppress or prevent orifice 710 from being blocked by unwanted tissue, for example.

[0109] In some implementations, for example, the diverter 705 may be provided with a coating 730. In some examples, the diverter 705 may be impregnated with a component 735. The coating 730 and / or component 735 may, for example, prevent and / or inhibit the anchoring and / or growth of unwanted tissue. In some examples, the component 735 may migrate to the surface and / or diffuse out (e.g., the diverter 705 may be drug-eluting).

[0110] In some examples, the shunt 705 can be operated to flush the body cavity 620 with a hot dispersing fluid (e.g., via a pump such as pump 750). For example, the body cavity 620 can be flushed with a cooler fluid to cool the body cavity 620 and / or surrounding tissues. For example, the body cavity 620 can be flushed with a hotter fluid to warm the body cavity 620 and / or surrounding tissues.

[0111] In some examples, the distributor 705 can operate as a heat source-free and / or absorber. For example, fluid can circulate within the lumen and / or tubes of the distributor 705. For example, the outer layer and / or the connection structure to the lumen can be thermally conductive (e.g., metal, graphene, carbon). The lumen can operate, for example, as a fluid radiator and / or heat exchanger. Fluid can be circulated to introduce cooler fluid (e.g., with or without flushing). Such examples can be configured and / or operated, for example, to cool body cavity 620 and / or surrounding tissue.

[0112] In some examples, the shunt 705 may be fluidly coupled to a heat source (e.g., a heater) and / or a radiator (e.g., for a cooling unit). The heat source and / or radiator may be, for example, remote (e.g., external to the body). In some examples, the heat source and / or radiator may be disposed on and / or within the body (e.g., an implant). For example, fluid may circulate (e.g., via an internal pump) through / across the radiator thermally coupled to a cooler part of the body (e.g., an external surface of a patient, such as in an air-conditioned environment).

[0113] In some examples, the shunt 705 can operate as a fluid heat source. Fluid can be circulated to introduce a hotter fluid. Such examples can be configured and / or operated, for example, to heat body cavity 620 and / or surrounding tissue.

[0114] In some cases, cooling brain tissue to as little as 2-3°F can reduce or cure epilepsy.

[0115] Shunt 705 can be configured and / or operated, for example, to treat brain trauma. Shunt 705 can be configured and / or operated, for example, to treat epilepsy. Shunt 705 can be configured and / or operated, for example, to treat meningitis. Shunt 705 can be configured and / or operated, for example, to treat neuroinflammation. Shunt 705 can be configured and / or operated, for example, to treat Alzheimer's disease. In some examples, shunt 705 can provide at least one component of a brain-computer interface. In some examples, shunt 705 can be configured and / or operated to (e.g., locally, systematically, remotely) deliver and / or determine the target (e.g., optimal) delivery time of a therapeutic agent. In some examples, shunt 705 can be configured and / or operated to treat hydrocephalus. In some examples, shunt 705 can be used before and / or after brain surgery. In some examples, shunt 705 can be configured and / or operated for brain pacing (e.g., electrical pacing). In some examples, the shunt 705 can be configured and / or operated for limb status management.

[0116] Figure 8 A schematic method of vertebral entry is depicted, such as, for example, regarding... Figure 1-2 Disclosed. In method 800, entry into the first vertebral body (VB) is created via the corresponding pedicle (step 805). A counter variable (e.g., “i”, as shown) is initialized (e.g., “1” as shown in step 810). A device (e.g., a catheter with a steerable drill tip) is advanced through the formed lumen (step 810) and into the first (i-th) vertebral body (step 815). The counter is incremented (step 820), and the catheter advances into subsequent vertebral bodies (e.g., through and / or around the intervertebral disc) until the number of vertebral bodies to be entered (“n”) is reached (step 825), where n>=1. In some embodiments, each vertebral body may be entered independently via the corresponding pedicle (e.g., steps 805-825 may be repeated multiple times, e.g., where n=1 for each or at least some repetitions). For example, subsequent operations (step 830) may be performed as depicted (e.g., as per [reference to...]). Figure 1-4 (As described, by way of example rather than limitation).

[0117] Figure 9 and Figure 10illustrates a schematic method related to a structure enhancement module (e.g., a spinal body adjusting device). In method 900, a counter variable i is initialized to 1 (step 905), and an i-th body of SBAD (e.g., 210 and / or 211) is set into an i-th vertebral body (step 910). The variable is incremented and the process is repeated until n SBAD bodies have been placed (step 920), where n>=1. The counter i is reinitialized to 1 (step 922), and an i-th body is operated (e.g., expanded, anchor deployed) to couple to a corresponding i-th vertebral body (step 930), and the counter is incremented (step 930) and the process is repeated until n SBAD bodies have been coupled (step 935). In some embodiments, for example, only selected bodies (e.g., m selected bodies < n selected bodies) can be operated to couple. In some embodiments, the bodies can be placed and / or coupled asynchronously (e.g., non-integer order). In some embodiments, additional steps can include coupling the bodies together (e.g., stacking, fastening, for example 210 to 211).

[0118] As depicted, a control member (e.g., 220) is operated (step 940) (e.g., tensioned, pulled, expanded, loosened) such that displacement of corresponding vertebrae is caused. For example, all control members can be operated. For example, the control members of selected SBAD can be operated (e.g., identically, differently, such as in different directions). Step 940 can be repeated, for example, as shown, until a target displacement is achieved (step 945).

[0119] Figure 10 illustrates method 1000, wherein an i-th body is operated to couple directly (step 925) after placing the i-th body (step 910).

[0120] Some embodiments (e.g., those of method 900, method 1000) can for example include additional steps, such as by way of example and not limitation: imaging; sensor readings, such as pressure, force, shear, orientation; trajectory prediction; difference analysis to determine differences among a pre-adjustment configuration, a post-adjustment configuration and / or a predicted post-adjustment configuration.

[0121] While various embodiments have been described with reference to the accompanying drawings, other embodiments are possible. In some embodiments, for example, steerable catheter 120, structure enhancement module 210, stent 505, balloon 605, shunt 705 and / or associated devices (e.g., controllers, sensors, actuators) can be connected to and / or configured in accordance with one or more devices. Example devices include devices disclosed at least with reference to:

[0122] • U.S. Patent Application Serial No. 18 / 313,249, entitled “Dynamically Controlled Cerebrospinal Fluid Shunt,” filed May 5, 2023, by Samuel Robert Browd et al. Figure 1-4 (For example, including diversion devices and associated devices)

[0123] • U.S. Patent Application Serial No. 63 / 365,407, entitled “Distributed Sensing and Control of Cerebrospinal Fluid,” filed on May 26, 2022, by Samuel Robert Brown et al. Figure 1-9 (For example, including brain shunts, CSF ion exchange devices, and phototherapy devices).

[0124] • U.S. Application Serial No. 63 / 477,158, entitled "Central Nervous System Monitoring and Intervention," filed on December 23, 2022, by Samuel Robert Brown et al. Figure 1 (For example, “splitter 105” and related devices);

[0125] • Paragraphs [0003-0040] of U.S. Patent Application Serial No. 63 / 477,162, entitled “Cerebrospinal Fluid Polarization”, filed December 23, 2022 by Samuel Robert Browd et al. (e.g., cerebrospinal fluid (CSF) polarization system (CSFPS) and related apparatus).

[0126] • U.S. Application Serial No. 63 / 488,412, entitled “Dynamic Triage System,” filed March 3, 2023, by Samuel Robert Browd et al. Figure 1-3 2 (e.g., intelligent shunts, non-invasive shunt diagnostic devices / systems, implantable devices); and

[0127] • A co-pending U.S. application entitled “Dynamically Guided Physician-Patient Interaction Engine” filed on October 13, 2023, by Samuel Robert Browd et al. (e.g., “Patient-Physician Interaction Engine (PPIE 110)” and associated apparatus); the entire contents of which are incorporated herein by reference.

[0128] Although an exemplary system has been described with reference to the accompanying drawings, other implementations may be deployed in other industrial, scientific, medical, commercial and / or residential applications.

[0129] In various embodiments, bypass circuitry implementations can be controlled in response to signals from analog or digital components, which may be discrete, integrated, or combinations thereof. Some embodiments may include programmable devices or combinations thereof (e.g., PLA, PLD, ASIC, microcontroller, microprocessor) and may include one or more data memories (e.g., cells, registers, blocks, pages) providing single-level or multi-level digital data storage capabilities, and these memories may be volatile, non-volatile, or combinations thereof. Some control functions may be implemented in hardware, software, firmware, or any combination thereof.

[0130] A computer program product may contain a set of instructions that, when executed by a processor device, cause the processor to perform a specified function. These functions may be performed in conjunction with a controlled device operatively communicating with the processor. A computer program product that may include software may be stored in a data storage device tangibly embedded in 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).

[0131] Although an example of a portable system has been described with reference to the above figures, other implementations can be deployed in other processing applications, such as desktop and networked environments.

[0132] Temporary auxiliary energy input can be received, for example, from a rechargeable or single-use battery, enabling use in portable or remote applications. Some embodiments can operate with other DC voltage sources, such as a 9V (nominal) battery. Alternating current (AC) input, which can be provided, for example, from a 50 / 60Hz power port or from a portable generator, can be received via a rectifier and appropriate scaling. Providing AC input (e.g., sine, square, or triangle wave) can include a line frequency transformer to provide voltage boost, voltage buck, and / or isolation.

[0133] While specific architectural features have been described, other features can be incorporated to improve performance. For example, caching techniques (e.g., L1, L2, ...) can be used. Random access memory may be included, for example, to provide temporary storage and / or load stored executable code or parameter information for use during runtime operation. Other hardware and software may be provided to perform operations, such as network or other communication using one or more protocols, wireless (e.g., infrared) communication, stored operating energy and power supply (e.g., battery), switching and / or linear power supply circuitry, software maintenance (e.g., self-test, upgrade), etc. One or more communication interfaces may be provided to support data storage and related operations.

[0134] Some systems can be implemented as computer systems that can be used with various implementations. For example, various implementations may include digital circuits, analog circuits, computer hardware, firmware, software, or combinations thereof. Apparatus can be implemented in a computer program product tangibly contained in an information carrier, such as a machine-readable storage device, for execution by a programmable processor; and methods can be executed by a programmable processor executing a program of instructions to perform the functions of various embodiments by manipulating input data and generating output. Various embodiments can advantageously be implemented in one or more computer programs that can be executed on a programmable system including at least one programmable processor coupled to receive data and instructions from a data storage system, at least one input device, and / or at least one output device, and to send data and instructions to the 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 an activity or produce a result. Computer programs can be written in any programming language, including compiled or interpreted languages, and can be deployed in any form, including as standalone programs or as modules, components, subroutines, or other units suitable for use in a computing environment.

[0135] As an example, suitable processors for executing instruction programs include both general-purpose and special-purpose microprocessors, which can comprise a single processor or one of multiple processors in any type of computer. Typically, the processor receives instructions and data from read-only memory or random access memory, or both. The basic components of a computer are a processor for executing instructions and one or more memories for storing instructions and data. Typically, a computer will also include one or more mass storage devices for storing data files, or operatively coupled to and communicating with them; such devices include disks, such as internal hard disks and removable disks; magneto-optical disks; and optical disks. Storage devices suitable for tangibly representing computer program instructions and data include all forms of non-volatile memory, including, as examples, semiconductor memory devices such as EPROM, EEPROM, and flash memory devices; disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM discs. The processor and memory may be supplemented or incorporated into ASICs (Application-Specific Integrated Circuits).

[0136] In some implementations, each system can be programmed with the same or similar information and / or initialized with substantially the same information stored in volatile and / or non-volatile memory. For example, a data interface can be configured to perform automatic configuration, automatic download, and / or automatic update functions when coupled to a suitable host device such as a desktop computer or server.

[0137] In some implementations, one or more user interface features can be customized to perform specific functions. Various embodiments can be implemented in computer systems including graphical user interfaces and / or internet browsers. To provide interaction with the user, some embodiments can 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, the display device may, for example, include a CRT (cathode ray tube). In some implementations, the display device may include, for example, an LCD (liquid crystal display). The display device (e.g., a monitor) may, for example, be configured and / or operated to display information to the user. Some embodiments may, for example, include a keyboard and / or pointing devices (e.g., a mouse, touchpad, trackball joystick), through which the user can provide input to the computer.

[0138] In various implementations, the system can communicate using suitable communication methods, devices, and technologies. For example, the system can communicate with compatible devices (e.g., devices capable of transmitting data to and / or from the system) using point-to-point communication, in which messages are transmitted directly from the source to the receiver via a dedicated physical link (e.g., fiber optic link, point-to-point cabling, daisy chain). Components of the system can exchange information via analog or digital data communication of any form or medium, including packet-based messaging over a communication network. Examples of communication networks include, for example, LANs (Local Area Networks), WANs (Wide Area Networks), MANs (Metropolitan Area Networks), wireless and / or optical networks, computers and networks forming the Internet, or some combination thereof. Other implementations can transmit messages to all or substantially all devices coupled together by the communication network via broadcast, for example, by using omnidirectional radio frequency (RF) signals. Other implementations can transmit messages characterized by high directionality, such as RF signals transmitted using directional (i.e., narrow-beam) antennas or infrared signals that may optionally be used with focusing optics. 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, frequency division, time division, or code division based multiplexing techniques, 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 cryptographic protection.

[0139] In various embodiments, the computer system may include Internet of Things (IoT) devices. IoT devices may include objects embedded with electronic devices, software, sensors, actuators, and network connectivity, enabling these objects to collect and exchange data. IoT devices can be used with wired or wireless devices by sending data to another device via an interface. IoT devices can collect useful data and then autonomously flow that data between other devices.

[0140] Various examples of modules can be implemented using circuitry, including a wide range of electronic hardware. By way of example, and not limitation, hardware may include transistors, resistors, capacitors, switches, integrated circuits, other modules, or combinations thereof. In various instances, the module may include analog logic, digital logic, discrete components, traces, and / or memory circuitry fabricated on a silicon substrate, the memory circuitry including various integrated circuits (e.g., FPGAs, ASICs), or combinations thereof. In some embodiments, the module may relate to the execution of pre-programmed instructions, software executed by a processor, or a combination thereof. For example, various modules may relate to both hardware and software.

[0141] In some aspects, the technology described herein relates to a skeleton body adjustment device comprising: a first body configured to be coupled within a first skeleton body; a second body configured to be coupled within a second skeleton body, the first body being telescopically connected to the second body; and at least one control member coupled to the first and second expansion bodies such that operation of the at least one control member causes at least one of the first and second bodies to be telescopically translated relative to each other, thereby causing corresponding movements of at least one of the first and second skeleton bodies relative to each other.

[0142] In some respects, the technology described herein relates to a skeletal body adjustment device, wherein at least one of a first body and a second body is expandable.

[0143] In some respects, the technology described herein relates to a skeletal body adjustment device, wherein at least one of a first body and a second body includes an expandable support.

[0144] In some respects, the technology described herein relates to a skeleton body adjustment device, further comprising: an anchor, coupled to at least one of a first body and a second body, the anchor being configured to be coupled to a corresponding skeleton body of the first skeleton body and the second skeleton body.

[0145] In some respects, the technology described herein relates to a skeleton body adjustment device, wherein the anchors are selectively operable from at least a loaded mode to a deployed mode, the deployed mode corresponding to coupling to the respective at least one skeleton body.

[0146] In some respects, the technology described herein relates to a skeleton body adjustment device, wherein the anchors are selectively operable from the deployment mode to the loading mode, the loading mode corresponding to decoupling from the corresponding at least one skeleton body.

[0147] In some respects, the technology described herein relates to a skeleton body adjustment device, which also includes a sensor coupled to at least one of a first body and a second body.

[0148] In some respects, the technology described herein relates to a skeleton body adjustment device, wherein the sensor includes at least one conductive lead coupled to and / or integrated into the anchor.

[0149] In some respects, the technology described herein relates to a skeleton body adjustment device, which also includes a controller operatively coupled to selectively operate the at least one control element.

[0150] In some respects, the technology described herein relates to a skeleton body adjustment device, wherein a controller is operatively coupled to a sensor, which is coupled to at least one of a first body and a second body.

[0151] In some respects, the technology described herein relates to a skeleton body adjustment device, wherein a controller selectively operates at least one control element based on input from at least one sensor.

[0152] In some respects, the technology described herein relates to a skeleton body adjustment device, which further includes a delivery mechanism.

[0153] In some respects, the technology described herein relates to a skeleton body adjustment device, wherein the delivery mechanism includes conductive leads coupled to and / or integrated into the anchor.

[0154] In some respects, the technology described herein relates to a skeleton body adjustment device and 13, wherein the conductive leads are optically conductive.

[0155] In some respects, the technology described herein relates to a skeleton body adjustment device and 13-14, wherein the conductive leads are conductive.

[0156] In some respects, the technology described herein relates to a skeleton body adjustment device, which also includes at least a second of the anchors.

[0157] In some respects, the technology described herein relates to a skeleton body adjustment device, wherein: a first body includes a first cavity, a second body includes a second cavity, and the first cavity and the second cavity are in fluid communication.

[0158] In some respects, the technology described herein relates to a method 1-16 in which a first body is disposed within a first vertebral body and a second body is disposed within a second vertebral body; the first body is coupled to the first vertebral body; the second body is coupled to the second vertebral body; and an operative control member is operated such that at least one of the first body and the second body is displaced relative to each other, causing a corresponding displacement in at least one of the first vertebral body and the second vertebral body.

[0159] In some respects, the technology described herein relates to a method in which the operation control component includes an operation tether.

[0160] In some respects, the technology described herein relates to a method in which displacement of at least one of a first body and a second body includes a telescopic extension of a skeletal body adjustment device, and a corresponding displacement of at least one of the first skeletal body and the second skeletal body includes an extension of the spine.

[0161] In some respects, the technology described herein relates to a method that further includes operating at least one anchor in a deployment mode such that at least one of a first body and a second body is coupled to at least one of a corresponding first skeleton body and a second skeleton body.

[0162] In some respects, the technology described herein relates to a method that also includes advancing the catheter through the lumen of the skeleton body adjustment device.

[0163] In some respects, the technology described herein relates to a method that further includes advancing a lead through and / or from a skeletal body adjustment device and into the vicinity of neural tissue, such that the lead is configured to monitor and / or stimulate the neural tissue.

[0164] In some aspects, the technology described herein relates to a body cavity fitting device comprising: an expandable stent configured to conform to a body cavity in an expanded configuration; and a plurality of contact modules extending at least partially to the exterior of the expandable stent, the plurality of contact modules being configured to contact tissue defining the body cavity and being configured to communicatively couple to a controller.

[0165] In some respects, the technology described herein relates to a body cavity connection device, wherein the expandable scaffold is configured to be placed in the ventricle of the human brain.

[0166] In some respects, the technology described herein relates to a cavity joining device, wherein the expandable stent comprises an exterior with a three-dimensional elliptical shape.

[0167] In some respects, the technology described herein relates to a body cavity engagement device, wherein at least one of the contact modules includes a sensor.

[0168] In some respects, the technology described herein relates to a body cavity engagement device, wherein at least one of the contact modules includes a conductive lead.

[0169] In some respects, the technology described herein relates to a body cavity connection device in which conductive leads are configured to selectively transmit electrical energy.

[0170] In some respects, the technology described herein relates to a body cavity connection device in which conductive leads are configured to selectively transmit optical energy.

[0171] In some respects, the technology described herein relates to a body cavity engagement device, wherein at least one of the contact modules is configured as an anchor.

[0172] In some respects, the technology described herein relates to a body cavity engagement device in which at least one of the contact modules is selectively deployed in response to a signal from a controller.

[0173] In some respects, the technology described herein relates to a body cavity engagement device in which multiple of the contact modules can be selectively deployed individually.

[0174] In some respects, the technology described herein relates to a body cavity connection device, which also includes a therapeutic agent impregnated in a stent.

[0175] In some respects, the technology described herein relates to a body cavity connection device configured as a brain-computer interface.

[0176] In some respects, the techniques described herein relate to intracavitary connection devices configured and / or operated to treat at least one of epilepsy, depression, and Parkinson's disease.

[0177] In some aspects, the technology described herein relates to a capsule comprising: a fluid-permeable outer layer defining a first chamber; an impermeable inner layer disposed within the outer wall and defining 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 the outer layer; and at least one control member configured to selectively operate the outer layer and / or the inner layer among a plurality of spatial configurations.

[0178] In some respects, the technology described herein relates to a capsule in which: a first spatial configuration of the plurality of spatial configurations includes a loading mode in which the outer and inner layers collapse along a duct, and a second spatial configuration of the plurality of spatial configurations includes a deployment mode in which the outer and inner layers are inflated.

[0179] In some respects, the technology described herein relates to a capsule, wherein the at least one control element is configured to at least operate the outer layer from a deployment mode to a loading mode.

[0180] In some respects, the technology described herein relates to a bladder in which operating at least one of the outer and inner layers from a loading mode to a deployment mode includes providing fluid such that at least one of the outer and inner layers is inflated.

[0181] In some respects, the technology described herein relates to a neurosurgical method comprising: providing a sac in a loading mode; introducing the sac into a nerve tissue cavity; inflating the sac into a first deployment mode having a first size; and manipulating at least one control member of the sac to operate the sac into a second deployment mode having a second size.

[0182] In some respects, the techniques described herein relate to a method that also includes: introducing fluid into a first cavity such that at least a portion of the outer surface of the outer layer is flushed.

[0183] In some respects, the techniques described herein relate to a method, which also includes: recovering fluid from a body cavity via a lumen.

[0184] In some respects, the technique described herein relates to a method in which a neural tissue cavity includes a ventricle.

[0185] In some aspects, the technology described herein relates to a cerebrospinal fluid (CSF) shunt system comprising: a shunt configured to be implanted in a patient and in fluid communication with CSF; a sensor operatively coupled to the shunt; a control module operatively connected to the sensor, the control module being configured to regulate the operation of the shunt based on at least one predetermined parameter; and a valve operatively connected to the control module and selectively operable by the control module such that the CSF flow rate is dynamically regulated.

[0186] In some respects, the technology described herein relates to a CSF shunt system, further comprising: a pump operatively connected to a shunt, the pump being configured to deliver a therapeutic agent through the shunt.

[0187] In some respects, the technology described herein relates to a CSF offloading system in which a control module is configured to remotely adjust the offloading operation.

[0188] In some respects, the technology described herein relates to a CSF shunt system in which sensors provide real-time data to a control module.

[0189] In some respects, the technology described herein relates to a CSF shunt control system, wherein the shunt is configured to be remotely adjusted by healthcare professionals via an interface with a control module.

[0190] In some respects, the technology described herein relates to a CSF splitter control system, wherein predetermined parameters are combined with at least one of the following: pressure, flow rate, and / or CSF composition.

[0191] In some respects, the technology described herein relates to a CSF diversion control system in which sensors are configured to monitor at least one of predetermined parameters.

[0192] Several implementations have been described. However, it should be understood that various modifications can be made. For example, advantageous results can be achieved if the steps of the disclosed technology are performed in a different order, or if the components of the disclosed system are combined in a different manner, or if additional components are added to the components. Therefore, other implementations are contemplated within the scope of the appended claims.

Claims

1. A frame body adjustment device, comprising: A first body, configured to be coupled within a first skeleton body; A second body is configured to be coupled within a second skeleton body, and the first body is retractably connected to the second body; At least one control member coupled to the first expansion body and the second expansion body, such that operation of the at least one control member causes at least one of the first body and the second body to translate telescopically relative to each other, thereby causing corresponding movement of at least one of the first skeleton body and the second skeleton body relative to each other.

2. The skeleton body adjustment device according to claim 1, wherein at least one of the first body and the second body is expandable.

3. The skeleton body adjustment device according to claim 2, wherein at least one of the first body and the second body includes an expandable support.

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

5. The skeleton body adjustment device according to claim 4, wherein the anchor can be selectively operated from at least a loading mode to a deployment mode, the deployment mode corresponding to coupling to the corresponding at least one skeleton body.

6. The skeleton body adjustment device according to claim 5, wherein the anchor can be selectively operated from the deployment mode to the loading mode, the loading mode corresponding to decoupling from the corresponding at least one skeleton body.

7. The skeleton body adjustment device according to 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 skeleton body adjustment device according to claim 7, wherein the sensor includes at least one conductive lead coupled to the anchor and / or integrated into the anchor.

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

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

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

12. The skeleton body adjustment device according to any one of claims 1-11, further comprising a delivery mechanism.

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

14. The skeleton body adjustment device according to any one of claims 8 and 13, wherein the conductive lead is optically conductive.

15. The skeleton body adjustment device according to any one of claims 8 and 13-14, wherein the conductive leads are conductive.

16. The skeleton body adjustment device according to any one of claims 4-15, further comprising at least a second anchor of the anchor.

17. The skeleton body adjustment device according to any one of claims 1-16, wherein: The first body includes a first lumen. The second body includes a second lumen, and The first lumen and the second lumen are in fluid communication.

18. A method for adjusting a vertebral body, the method comprising: A pathway to the first vertebral body is created via the pedicle of the first vertebral body; A pathway to the second vertebral body is created via the pedicle of the second vertebral body; The skeletal body adjustment device according to any one of claims 1-16 is provided such that the first body is disposed in the first vertebral body and the second body is disposed in the second vertebral body; Couple the first main body to the first vertebral body; Couple the second body to the second vertebral body; as well as, The operating control component causes at least one of the first body and the second body to shift relative to each other, thereby causing a corresponding displacement 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 includes operating the tether.

20. The method according to any one of claims 18-19, wherein the displacement of at least one of the first body and the second body includes a telescopic extension of the skeleton body adjustment device, and the corresponding displacement of at least one of the first skeleton body and the second skeleton body includes an extension of the spine.

21. The method according to any one of claims 18-20, further comprising operating at least one anchor in a deployment mode such that at least one of the first body and the second body is coupled to at least one of the first skeleton body and the second skeleton body.

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

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

24. A body cavity connection device, comprising: An expandable stent configured to conform to a body cavity in an expandable configuration; Multiple contact modules, which extend at least partially to the exterior of the expandable stent, are configured to contact tissue defining the body cavity and are configured to be communicatively coupled to a controller.

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

26. The cavity joining device of claim 25, wherein the expandable support includes the external three-dimensional elliptical shape.

27. The body cavity joining device according to any one of claims 24-26, wherein at least one of the contact modules includes a sensor.

28. The body cavity joining device according to any one of claims 24-27, wherein at least one of the contact modules includes a conductive lead.

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

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

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

33. The body cavity engagement device according to claim 32, wherein the plurality of the contact modules can be selectively deployed individually.

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

35. The body cavity connection device according to any one of claims 24-34, wherein the body cavity connection device is configured as a brain-computer interface.

36. The intracavitary connection device according to any one of claims 24-35, wherein the intracavitary connection device is configured and / or operated to treat at least one of epilepsy, depression and Parkinson's disease.

37. A capsule, the capsule comprising: A fluid-permeable outer layer defining a first chamber; An impermeable inner layer is disposed within the outer wall and defines a second chamber between the outer layer and the inner layer and a third chamber within the inner layer; A conduit that defines a lumen and is disposed within the inner wall and is in external fluid communication with the third chamber and the outer layer; as well as, At least one control element, the at least one control element being configured to selectively operate the outer layer and / or the inner layer among a plurality of spatial configurations.

38. The capsule according to claim 37, wherein: The first spatial configuration of the plurality of spatial configurations includes a loading mode in which the outer layer and the inner layer collapse along the conduit. The second spatial configuration of the plurality of spatial configurations includes a deployment mode in which the outer layer and the inner layer are inflated.

39. The capsule of claim 38, wherein the at least one control member is configured to operate at least the outer layer from the deployment mode to the loading mode.

40. The capsule according to any one of claims 38-39, wherein operating at least one of the outer layer and the inner layer from the loading mode to the deployment mode comprises providing fluid such that the at least one of the outer layer and the inner layer is inflated.

41. A neurosurgical procedure, comprising: The capsule according to any one of claims 37-40 is provided in a loading mode; The capsule is introduced into the nerve tissue cavity; The bladder is inflated to a first deployment configuration having a first size; as well as Operate the at least one control member of the capsule to operate the capsule in a second deployment mode having a second size.

42. The method of claim 41, further comprising: Fluid is introduced into the first cavity to flush at least a portion of the outer surface of the outer layer.

43. The method according to any one of claims 40-42, further comprising: Fluid is recovered from the body cavity via the lumen.

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

45. A cerebrospinal fluid (CSF) shunt system, comprising: The shunt is configured to be implanted in the patient and is in fluid communication with the CSF. A sensor operatively coupled to the shunt; A control module operably connected to the sensor, the control module being configured to adjust the operation of the shunt based on at least one predetermined parameter; as well as A valve operably connected to and selectively operated by the control module allows the CSF flow rate to be dynamically regulated.

46. ​​The CSF splitting system according to claim 45, further comprising: A pump operably connected to the shunt, the pump being configured to deliver a therapeutic agent through the shunt.

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

48. The CSF diversion system according to any one of claims 45-47, wherein the sensor provides real-time data to the control module.

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

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

51. The CSF diversion control system according to any one of claims 45-50, wherein the sensor is configured to monitor at least one of the predetermined parameters.

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