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WO2025081167A1 - Dispositifs rachidiens et neurochirurgicaux - Google Patents

Dispositifs rachidiens et neurochirurgicaux Download PDF

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Publication number
WO2025081167A1
WO2025081167A1 PCT/US2024/051288 US2024051288W WO2025081167A1 WO 2025081167 A1 WO2025081167 A1 WO 2025081167A1 US 2024051288 W US2024051288 W US 2024051288W WO 2025081167 A1 WO2025081167 A1 WO 2025081167A1
Authority
WO
WIPO (PCT)
Prior art keywords
skeletal
shunt
adjustment device
bladder
fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/051288
Other languages
English (en)
Inventor
Samuel Robert Browd
Ryan J. Douglas
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to PCT/US2024/051466 priority Critical patent/WO2025081195A1/fr
Publication of WO2025081167A1 publication Critical patent/WO2025081167A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

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    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
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    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7014—Longitudinal elements, e.g. rods with means for adjusting the distance between two screws or hooks
    • A61B17/7016—Longitudinal elements, e.g. rods with means for adjusting the distance between two screws or hooks electric or electromagnetic means
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    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2002/4495—Joints for the spine, e.g. vertebrae, spinal discs having a fabric structure, e.g. made from wires or fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36062—Spinal stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/065—Light sources therefor
    • A61N2005/0651—Diodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/0618—Psychological treatment

Definitions

  • Pseudotumor Cerebri also known as idiopathic intracranial hypertension, is characterized by increased intracranial pressure without an apparent cause. Symptoms include severe headaches, vision problems, and ringing in the ears. Treatment may involve medications to reduce CSF production or surgical procedures to relieve pressure. A subarachnoid hemorrhage may involve bleeding into the subarachnoid space, where cerebrospinal fluid circulates. This condition often results from a ruptured aneurysm and can lead to sudden, severe headaches, nausea, and loss of consciousness. Immediate medical intervention is crucial, often requiring surgical repair of the aneurysm and management of CSF pressure. Diseases and disorders affecting the brain's ventricles and cerebrospinal fluid can have profound effects on neurological function. Early diagnosis and appropriate treatment are essential to manage these conditions effectively and improve patient outcomes.
  • the vertebral column plays a crucial role in supporting the body’s structure and protecting the spinal cord.
  • Diseases and disorders affecting the vertebral column can lead to severe pain, disability, and neurological complications.
  • One prevalent condition is intervertebral disc degeneration, which occurs when the discs that cushion the vertebrae deteriorate over time, leading to back pain, stiffness, and reduced mobility.
  • Scoliosis characterized by an abnormal lateral curvature of the spine, can cause uneven shoulders, waist, and hips, and in severe cases, can impair lung and heart function.
  • spinal stenosis where the spinal canal narrows, compressing the spinal cord and nerves, resulting in pain, numbness, and muscle weakness.
  • herniated discs also known as a slipped or ruptured disc, occurs when the soft inner core of a spinal disc leaks out through a tear in the outer layer, pressing on nearby nerves and causing pain, tingling, and weakness in the affected area.
  • Vertebral fractures often due to osteoporosis or trauma, can lead to acute back pain and long-term spinal deformity.
  • conditions like ankylosing spondylitis an inflammatory disease that can cause some of the small bones in the spine to fuse, restrict mobility and result in a stooped posture. Prompt diagnosis and appropriate treatment are essential to managing these conditions and improving patient outcomes.
  • apparatus and related methods relate to a skeletal body adjustment device (SB AD) with telescopically connected bodies.
  • SB AD may include control members configured to induce relative translation between the bodies.
  • apparatus and related methods relate to a body cavity conforming shunt.
  • the shunt may, for example, include selectively deployable contact members.
  • the contact members may, by way of example and not limitation, be configured as anchors, sensors, and/or therapy delivery devices.
  • apparatus and related methods relate to a multi-layer bladder (MLB) selectively deployable in a body cavity.
  • the MLB may, for example, include sensing and/or delivery components.
  • the MLB may, for example, include control member(s) and/or pressure control(s) configured to control shape, size, and/or pressure of the MLB.
  • apparatus and related methods relate to a dynamically controlled cerebrospinal fluid (CSF) shunt system.
  • CSF cerebrospinal fluid
  • a vertebral access system e.g., skeletal body adjustment device (SBAD)
  • SBAD skeletal body adjustment device
  • fusions e.g., posterior lumbar interbody fusion (PLIFs), transforaminal lumbar interbody fusion (TLIFs), extreme lateral interbody fusion (XLIFs)
  • collapsed / compressed discs scoliosis intervention, neuro-foramen compression, and/or bone-on- bone pain.
  • Some embodiments may, for example, advantageously provide structural reinforcement modules (e.g., SBAD(s)) adjustable to, for example, advantageously reduce and/or increase mechanical loading applied, such as, for example, based on detected mechanical load profiles.
  • structural reinforcement modules e.g., SBAD(s)
  • Some embodiments may, for example, advantageously deliver one or more therapies.
  • therapies may include, for example, pharmacology therapies, cellular therapies, chemotherapy, bone stimulation agents, bone growth inhibition agents, and/or biologies.
  • Some embodiments may, for example, advantageously provide electromagnetic stimulation via a stent, and/or SBAD.
  • electromagnetic stimulation may be advantageously provided through channel(s) in a vertebral body (e.g., via an SBAD).
  • Some embodiments may, for example, advantageously provide a stent deployable into a brain ventricle or other nervous system cavity.
  • some embodiments may advantageously be conformable and/or custom created for patient-specific cavity geometry.
  • Some embodiments may, for example, advantageously provide a shunt configured as a brain-computer interface (e.g., sensing, therapy).
  • Some embodiments may, for example, advantageously provide a bladder deployable into a body cavity (e.g., a brain ventricle or other nervous system cavity).
  • a body cavity e.g., a brain ventricle or other nervous system cavity.
  • some embodiments may advantageously provide a conformable bladder configured to selectively apply pressure to a body cavity.
  • some embodiments may advantageously be used to treat bleeding (e.g., via tamponade, irrigation).
  • Some embodiments may, for example, advantageously provide thermal regulation (e.g., via irrigation).
  • Some embodiments may, for example, advantageously reduce adhesion to tissue and/or blood.
  • Some embodiments may regulate a pressure and/or geometry of a shunt and/or bladder.
  • Some embodiments may, for example, advantageously dynamically control cerebrospinal fluid (CSF) flow using sensors and a control module.
  • CSF cerebrospinal fluid
  • some embodiments may advantageously provide a minimally invasive CSF shunt.
  • Some embodiments may, for example, advantageously permit CSF flow to be remotely regulated, such as by a healthcare provider, for example.
  • a CSF shunt may, for example, advantageously automatically regulate CSF flow by automatically adjusting a CSF shunt's operation, such as based on monitored parameters, for example.
  • FIG. 1 depicts an illustrative vertebral access system and associated method.
  • FIG. 2 and FIG. 3 depict structural reinforcement modules.
  • FIG. 4 depicts deployment of an inter-vertebral lead, such as using the system, method, and/or module(s) of FIGS. 1, 2, and/or 3.
  • FIG. 5 depicts an illustrative body-conforming stent.
  • FIG. 6 depicts an illustrative multi-layer bladder.
  • FIG. 7 depicts an illustrative shunt configured, for example, to dynamically regulate flow of cerebrospinal fluid (CSF).
  • CSF cerebrospinal fluid
  • FIG. 9 and FIG. 10 depict illustrative methods related to structural reinforcement module(s) (e.g., skeletal body adjustment device(s)).
  • structural reinforcement module(s) e.g., skeletal body adjustment device(s)
  • FIG. 1 depicts an illustrative vertebral access system and associated method.
  • a vertebra 105 has one or more processes, including transverse process 110.
  • the vertebra 105 includes one or more pedicles 115.
  • a vertebral access system may, for example, include a steerable catheter 120.
  • the steerable catheter may be operatively, communicably, fluidly, mechanically, optically, and/or electrically coupled to one or more actuators, sensors, and/or interfaces (e.g., as shown).
  • An incision may be made, for example, to access the pedicle 115.
  • An aperture may be formed in the pedicle 115.
  • a channel may be tunneled (motion 1 A) from the aperture at the pedicle 115 to the vertebral body 116.
  • the vertebral body may include marrow.
  • the vertebral body may, for example, have few or no nerves.
  • the spinal cord as shown, may be disposed in the vertebral foramen.
  • the catheter 120 may be operably (e.g., electrically) coupled to an electrical stimulation module 135.
  • electrical stimulation may be provided (e.g., to nervous tissue) within the body via the route illustrated in FIG. 1.
  • other tools and/or modules may, for example, be operably coupled to the catheter 120 and/or introduced into and/or into communication with the body via the route shown in FIG. 1.
  • structural reinforcement modules may be delivered into the channel.
  • FIG. 2 and FIG. 3 depict structural reinforcement modules 210 (e.g., skeletal body adjustment device(s)).
  • a reinforcement module 210 may include stacking components.
  • an outer stacking element 210 and an inner stacking element 211 may be ‘stacked’ together (e.g., in alternating order, such as shown).
  • the structural reinforcement modules 210 and the inner stacking element 211 may, for example, be slidingly (e.g., telescopically) coupled.
  • the structural reinforcement modules 210 may define one or more inner lumens (e.g., for later access through the channel, for delivery of fluid, for delivery of mechanical and/or electrical components).
  • the structural reinforcement modules 210 may be provided with anchoring modules 215.
  • the anchoring modules 215 may be deployed (e.g., motion 2A) after and/or during expansion of the structural reinforcement modules 210 into a deployed shape.
  • the anchoring modules 215 may, for example, be pointed (e.g., as shown) and/or have a ‘pad’ shape configured to engage (e.g., frictionally) surrounding tissue (e.g., as shown in the ‘zoom-in’ dashed lines to the upper-left of FIG. 2).
  • control members may include tethers 220 (e.g., flexible, rigid), may be attached to the anchoring modules 215 (e.g., internal, external), such as shown in FIG. 3.
  • the tethers 220 may be operated to apply tension between two anchoring modules 215 (e.g., to urge two of the structural reinforcement modules 210 towards each other).
  • one or more of the tethers 220 e.g., operating as ‘struts’
  • a user may advantageously selectively operate the tethers 220 to anchor to selected anchoring modules 215 and to apply selected forces to the selected anchoring modules 215 to achieve a desired shape (e.g., bent, straight, compressed, expanded) and/or mechanical loading of the structural reinforcement modules 210.
  • a desired shape e.g., bent, straight, compressed, expanded
  • control members may include screws and/or other inclined planes.
  • control members may include motors and/or other sources of motive power.
  • control members may include drums and/or cables.
  • control members may be adjustable.
  • a physician may re-access the tethers 220 and tighten or loosen them to apply incremental adjustments over time (e.g., in response to physical growth and/or remodeling).
  • the tethers 220 may be remotely adjustable.
  • the tethers 220 may be coupled to a remote anchor point(s) (e.g., accessible by a physician, such as in and/or out of the body).
  • the tethers 220 may be coupled to an actuator (e.g., motor, fluid pump). The actuator may be operated to adjust the tethers 220.
  • mechanical adjustment parameters may be provided. For example, resistance to sliding and/or rotation of a mechanical joint in and/or between components of the structural reinforcement modules 210 may be provided. Extension adjustments may, for example, be provided. Adjustments may be statically made during implantation. Adjustments may, for example, be dynamically made after implantation (e.g., hours, days, weeks, months, years).
  • the structural reinforcement modules 210 may be configured as an expandable stent (e.g., ‘cage’).
  • the structural reinforcement modules 210 may, for example, be impregnated with one or more active ingredients (e.g., drug-eluting stent).
  • the structural reinforcement modules 210 may be provided with delivery mechanisms (e.g., tubes, fluid pathways, valves) for therapeutic delivery.
  • Therapeutic delivery may, for example, include pharmacology therapies.
  • Therapeutic delivery may, for example, include cellular therapies.
  • Therapeutic delivery may, for example, include chemotherapy (e.g., local chemotherapy).
  • Therapeutic delivery may, for example, include bone stimulation agents.
  • Therapeutic delivery may, for example, include bone growth inhibition agents.
  • Therapeutic delivery may, for example, include biologies.
  • therapies may be delivered through mechanisms other than and/or additional to the structural reinforcement modules 210 (e.g., through catheters, pumps).
  • the approach described above may be made without inserting structural reinforcement.
  • electromagnetic stimulation may be provided (e.g., through the channel(s) in the vertebral body, integrated in and/or deployed through the structural reinforcement modules).
  • leads may be disposed near the spinal cord.
  • Leads may be disposed near branching nerves.
  • Leads may, for example, be disposed near the cerebrospinal fluid (CSF).
  • Leads may, for example, include electrical leads (e.g., electrical conductors).
  • Leads may, for example, include optical transmitting leads (e.g., fiber optic cable).
  • a stimulation source e.g., light source, electrical source
  • stimulation may be applied to a nerve 410 exiting the vertebra 105.
  • an inter-vertebral body lead 415 may be disposed adjacent to and/or contacting the nerve 410.
  • the inter-vertebral body lead 415 may, for example, be operated to sense and/or stimulate the nerve 410.
  • the inter-vertebral body lead 415 may, for example, terminate in one or more terminal modules 420 (e.g., sensor, stimulator).
  • the inter-vertebral body lead 415 may be connected to a generator 425 (e.g., electrical generator, light generator, chemical pump).
  • the inter-vertebral body lead 415 may, for example, be coupled (e.g., communicatively) to one or more sensors and/or control module(s) 430 disposed in other portions of the body (e.g., brain cortical sensor, such as including electroencephalogram (EEG) monitoring device(s)).
  • EEG electroencephalogram
  • FIG. 5 depicts an illustrative body-conforming stent.
  • a stent 505 may be deployed into a body cavity.
  • the stent 505 may be configured for a nervous system cavity.
  • the stent 505 may be configured for a brain ventricle (e.g., frontal ventricle).
  • the stent 505 may, for example, be delivered via an open corticectomy, for example.
  • the stent 505 may, for example, be delivered via an endoscope.
  • the stent 505 may, for example, be deployed by a catheter 510 (e.g., steerable catheter, endoscope).
  • the stent 505 may, for example, be expanded by a balloon 515.
  • the stent 505 may, for example, be coupled (e.g., fluidly) to a shunt 525 (e.g., hydrocephalus shunt).
  • the stent 505 may, for example, be connected to and/or provided with one or more sensors and/or actuators 520.
  • a controller 530 may, as depicted, be operably coupled to one or more sensors and/or actuators.
  • a body 540 of the stent 505 may, for example, be shaped to fit a ventricle.
  • the stent 505 may, for example, be provided with expandable members 545.
  • the expandable members 545 may, for example, be expanded (e.g., motion 506) before, during, and/or after expansion of the body 540 from a delivery state (e.g., collapsed) to a deployed state (e.g., expanded).
  • the expandable members 545 may, for example, act to provide mechanical and/or communicative (e.g., electrical) contact with surrounding body tissue (e.g., ventricular walls).
  • One or more of the expandable members 545 may, for example, be provided with contact modules 550.
  • the contact modules 550 may include a mechanical anchor (e.g., pad, microneedles).
  • the contact modules 550 may include an electrical contact (e.g., conductive pad).
  • the contact modules 550 may include an actuator (e.g., LED) and/or sensor(s) (e.g., force / pressure sensor, lab on a chip, EEG electrode, fluid flow sensor, CSF analyte(s) sensor).
  • the stent 505 may, for example, be impregnated and/or coated with therapeutic agents (e.g., pharmacologic agents).
  • a pump 535 may, for example, deliver therapeutic agents (e.g., in response to a controller 530) via the stent 505.
  • Deployment of the stent 505 may, for example, be controlled based on sensors (e.g., in the contact modules 550).
  • the body 540 may include multiple, selectively deployed segments. The segments may, for example, be independently controlled and/or deployed. For example, a multi-segment deployment may advantageously enable custom fitting of the stent 505 to a specific patient and/or cavity.
  • Some embodiments may, for example, advantageously be configured and/or operated to treat epilepsy. Some embodiments may, for example, advantageously be configured and/or operated to treat depression (e.g., chronic). Some embodiments may, for example, advantageously be configured and/or operated to treat obsessive compulsive disorder. Some embodiments may, for example, advantageously be configured and/or operated to treat Parkinson’s disease. Some embodiments may, for example, advantageously be configured and/or operated to provide deep brain stimulation. Some embodiments may, for example, advantageously be configured and/or operated to provide focal drug delivery. Some embodiments may, for example, advantageously be configured and/or operated to provide light catalyzed effects.
  • Some embodiments may, for example, advantageously provide multiple modalities.
  • some embodiments may synchronize treatments (e.g., light delivery, electrical stimulation, pharmaceutical delivery, mechanical loading).
  • therapy may be synchronized with each other, with transient events, and/or with biorhythms.
  • Synchronization may, for example ,be predetermined.
  • Synchronization may, for example, be personalized.
  • drug delivery may be timed to achieve maximum effect with minimal dose (e.g., after electrical stimulation, during photo-stimulation, after detected events and/or thresholds).
  • a hydrocephalus shunt e.g., as disclosed at least with reference to may be provided with backflushing.
  • backflushing may be generated based on pulsatile backflow.
  • FIG. 6 depicts an illustrative bladder 605.
  • the bladder 605 may, for example, be selectively deployed in a body cavity.
  • a body cavity 620 may be in neural tissue.
  • the body cavity 620 may be a ventricle in a patient’s brain.
  • Operations may, for example, have been performed in the body cavity 620.
  • the body cavity 620 may have been created by surgery (e.g., removing a portion of tissue).
  • the surrounding tissue may be perfused by vasculature 625 (e.g., blood vessels).
  • the vasculature 625 may, for example, bleed into the body cavity 620 in response to intervention (e.g., surgery).
  • the bladder 605 may, for example, be configured to conform to at least some of the body cavity 620.
  • the bladder 605 may be configured as a deployable bladder.
  • the bladder 605 may, for example, be multi-segmented.
  • the bladder 605 may include a stent (e.g., stent 505).
  • the bladder 605 may be provided with an outer layer 610 and an inner layer 615.
  • the inner layer 615 may, for example, be highly compliant.
  • the inner layer 615 may conform to a shape of the body cavity 620 at or substantially at ambient pressure (e.g., environmental pressure, normal pressure within the body cavity 620).
  • the outer layer 610 may, for example, be highly compliant.
  • the outer layer 610 may conform to a shape of the body cavity 620 at or substantially at ambient pressure (e.g., environmental pressure, normal pressure within the body cavity 620).
  • the catheter controller 655 may include human -machine interface(s) (e.g., knobs; levers; touchscreens; feedback mechanics such as haptic, audio, visual).
  • the catheter controller 655 may, for example, include automatic control module(s).
  • the catheter controller 655 may communicate with sensors (not shown). Sensor(s) may, for example, be disposed in, on, and/or about the bladder 605.
  • sensors 660 may, for example, be disposed remote the bladder 605 (e.g., EEG leads, analyte monitor, heart rate monitor, oxygenation monitor).
  • the inner layer 615 may, as depicted, define an inner bladder 645.
  • the inner bladder 645 may, for example, be fluid-tight (e.g., water-tight, air-tight).
  • a volume and/or pressure of fluid in the inner bladder 645 may, for example, be selectively controlled (e.g., by a pump 670 fluidly coupled to the inner bladder 645, shown in this example as operably coupled to the 655) to selectively inflate / deflate the inner bladder 645.
  • the fluid channel 630 may, for example, be provided with one or more apertures (not shown) to the outer volume 650.
  • the fluid channel 630 may be selectively fluidly coupled (e.g., by a valve(s), not shown) to the outer volume 650.
  • the inner bladder 645 may be inflated until a target pressure threshold is reached.
  • the vasculature 625 may be bleeding into the body cavity 620.
  • the inner bladder 645 may be inflated (e.g., via the fluid channel 630) until the bladder 605 is pressurized against the surface of the body cavity 620 (e.g., against brain tissue).
  • the bladder 605 may effectively act to tamponade the surface of the body cavity 620.
  • the pressure may, for example, slow or stop bleeding of the vasculature 625.
  • some embodiments may oscillate pressure and/or volume of the bladder 605.
  • oscillating pressure and/or volume may induce oscillating dimension(s) of the bladder 605.
  • the oscillation may, for example, release ‘sticking’ of the bladder 605 to tissue and/or blood.
  • the oscillation may, for example, be induced by pulsation of fluid in the inner bladder 645 and/or outer volume 650.
  • Cords 665 may, for example, be disposed in and/or about one or more of the layers (e.g., the outer layer 610, the inner layer 615). The cords 665 may, for example, be pulled to constrain the bladder 605 into a shape suitable for withdrawal (e.g., collapsed along a longitudinal axis, such as rather than bunched / wadded).
  • internal struts and/or tethers 675 may, for example, constrain geometry of the bladder 605.
  • the struts and/or tethers may prevent balling or wadding of the bladder 605.
  • the tethers 675 may constrain the bladder 605 into a longitudinally extending shape when collapsed.
  • the tethers 675 may, for example, be elastic (e.g., stretchable when the bladder 605 is pressurized, with a return to substantially the same length when pressure is released).
  • One or more of the sensor 660 may, for example, monitor for bleeding.
  • analyte sensor(s) may monitor for the presence of blood and/or bleeding-related components (e.g., hemoglobin).
  • optical sensor(s) may monitor for a color of fresh blood.
  • temperature sensor(s) may monitor for a change in temperature corresponding to bleeding.
  • conductivity sensors, resistance sensors, and/or capacitance sensors may monitor for a change in conductivity, resistance, and/or capacitance corresponding to the presence of fresh blood.
  • Deflation and/or inflation of the bladder 605 may be adjusted and/or therapeutical agent(s) may be delivered in response to the detection of blood.
  • the bladder 605 may be operated to irrigate the body cavity 620 with a thermally differentiated fluid (e.g., by a pump such as pump 670).
  • a thermally differentiated fluid e.g., by a pump such as pump 670.
  • the body cavity 620 may be irrigated with cooler fluid to cool the body cavity 620 and/or surrounding tissue.
  • the body cavity 620 may be irrigated with warmer fluid to warm the body cavity 620 and/or surrounding tissue.
  • the bladder 605 may operate as a thermal source and/or sink.
  • fluid may be circulated in the inner bladder 645 and/or outer volume 650.
  • the outer layer 610 and/or connective structures to the inner layer 615 may be thermally conductive (e.g., metallic, graphene, carbon).
  • the inner bladder 645 may, for example, be operated as a fluid heatsink and/or heat exchange. Fluid may be circulated to introduce cooler fluid (e.g., with or without irrigation). Such examples may, for example, be configured and/or operated to cool the body cavity 620 and/or surrounding tissue.
  • the bladder 605 may be fluidly coupled to a heat source (e.g., heater) and/or heatsink (e.g., for refrigeration unit).
  • the heat source and/or heatsink may, for example, be remote (e.g., external to the body).
  • the heat source and/or heatsink may be disposed on and/or in the body (e.g., an implant).
  • fluid may be circulated (e.g., by an internal pump) through / across a heatsink thermally coupled to a cooler portion of the body (e.g., an external surface of the patient, such as in an air-conditioned environment).
  • the inner bladder 645 may be operated as a fluid heat source. Fluid may be circulated to introduce warmer fluid. Such examples may be configured and/or operated to warm the body cavity 620 and/or surrounding tissue, for example.
  • cooling brain tissue by as little as 2-3°F may reduce or cure epilepsy.
  • the bladder 605 may, for example, be configured and/or operated to treat brain trauma.
  • the bladder may, for example, be configured and/or operated to treat epilepsy.
  • the bladder may, for example, be configured and/or operated for treat meningitis.
  • the bladder 605 may, for example, be configured and/or operated for treat neuro-inflammation.
  • the bladder 605 may, for example, be configured and/or operated for treat Alzheimer’s.
  • a sealing member 680 and/or a sealing member 685 may be provided.
  • the sealing member(s) may be configured as a single or multiple (e.g., nested) collar(s).
  • the sealing member(s) may, for example, seal against the fluid channel 630 (e.g., conduit).
  • the collar(s) may be sliding relative to each other.
  • the control members(s) e.g., cords 665) may be configured to be operated through the sealing member(s), for example.
  • FIG. 7 depicts an illustrative shunt 705.
  • the shunt 705 may be configured and/or operated as a brain shunt (as depicted).
  • the shunt 705 may, for example, be configured and/or operated as a hydrocephalus shunt.
  • the shunt 705 is implanted in a patient’s brain 702 (e.g., fluidly coupled to a body cavity 620, such as a frontal ventricle) such as, for example, through the patient’s skull 701.
  • the shunt 705, in the depicted example, is coupled to a controller 745 (e.g., which may include and/or be coupled to a catheter controller 655).
  • the shunt 705 may, for example, be fluidly coupled to a pump 750.
  • the pump 750 as depicted, is operably coupled to the controller 745.
  • the shunt 705 terminates in a body cavity 620.
  • the shunt 705 may be provided (e.g., at a distal end in the body cavity 620) with apertures 710. Fluid in the body cavity 620 may, for example, enter the shunt 705 via the apertures 710. The fluid may, for example, be disposed of via the shunt 705 (e.g., via the pump 750).
  • tissue e.g., brain tissue
  • tissue may grow onto and/or anchor to the shunt 705.
  • the tissue may grow to at least partially occlude the apertures 710.
  • Some embodiments may, for example, backflush to expel fluid 720 through the apertures 710. The backflushing may, for example, be performed automatically (e.g., in response to a signal from the controller 745).
  • the backflushing may be controlled according to a relationship, such as shown in plot 725.
  • backflushing may be operated for a specific time and/or volume as a function of an amount of fluid drained from the body cavity 620 through the shunt 705.
  • one or more sensors 740 may monitor fluid flow and/or pressure (e.g., intracranial pressure).
  • a predetermined ratio e.g., or ratio range
  • V_D volume dispensed
  • V_B volume backflushed
  • backflushing may be operated according to a 2: 1 ratio of V_D : V_B.
  • the controller 745 may operate valves and/or the pump 750 to backflush periodically based on V_D and/or V_B.
  • backflushing may be pulsatile.
  • the controller 745 may operate valves and/or the pump 750 to pulse fluid (e.g., at transiently elevated pressures relative to normal pressure in the brain) and/or to oscillate fluid (e.g., transient pressure burst out of the shunt 705 followed by transient pressure suction into the shunt 705).
  • the backflushing relationship may be adjustable (e.g., by a physician).
  • the backflushing relationship may, for example, be learned (e.g., based on pressure and/or fluid flow data for the patient). For example, as static pressure rises and/or a flow of dispensing (Q_D) decreases, a backflushing relationship may be increased to increase backflushing.
  • the increased backflushing may, for example, advantageously reduce occlusion.
  • multiple channels may be operated to cooperate to irrigate the surface of the shunt 705.
  • fluid may be dispensed from some apertures 710 and suction may be applied to corresponding (e.g., adjacent) apertures 710.
  • simultaneous coordinated dispensing and suction may induce fluid flow across the surface of the shunt 705.
  • the irrigation may, for example, advantageously induce localized elevated fluid flow sufficient to disrupt tissue anchored to the shunt 705.
  • the localized elevated fluid flow may, for example, prevent or reduce damage to surrounding brain tissue.
  • the actuators 755 may include electrical emitters.
  • the electrical emitters may induce a low level of electrical current in the shunt 705 itself.
  • the electrical current may, for example, advantageously inhibit or prevent occlusion of the apertures 710 by unwanted tissue.
  • the shunt 705 may be provided with a coating 730.
  • the shunt 705 may be impregnated with components 735.
  • the coating 730 and/or the components 735 may, for example, prevent and/or inhibit anchoring and/or growth of the unwanted tissue.
  • the components 735 may migrate to the surface and/or diffuse out (e.g., the shunt 705 may be drug-eluting).
  • the shunt 705 may be operated to irrigate the body cavity 620 with a thermally differentiated fluid (e.g., by a pump such as pump 750.
  • a thermally differentiated fluid e.g., by a pump such as pump 750.
  • the body cavity 620 may be irrigated with cooler fluid to cool the body cavity 620 and/or surrounding tissue.
  • the body cavity 620 may be irrigated with warmer fluid to warm the body cavity 620 and/or surrounding tissue.
  • the shunt 705 may operate as athermal source and/or sink.
  • fluid may be circulated in an inner cavity and/or lumen of the shunt 705.
  • an outer layer and/or connective structures to the inner cavity may be thermally conductive (e.g., metallic, graphene, carbon).
  • the inner cavity may, for example, be operated as a fluid heatsink and/or heat exchange.
  • Fluid may be circulated to introduce cooler fluid (e.g., with or without irrigation).
  • Such examples may, for example, be configured and/or operated for cool the body cavity 620 and/or surrounding tissue.
  • the shunt 705 may be fluidly coupled to a heat source (e.g., heater) and/or heatsink (e.g., for refrigeration unit).
  • the heat source and/or heatsink may, for example, be remote (e.g., external to the body).
  • the heat source and/or heatsink may be disposed on and/or in the body (e.g., an implant).
  • fluid may be circulated (e.g., by an internal pump) through / across a heatsink thermally coupled to a cooler portion of the body (e.g., an external surface of the patient, such as in an air-conditioned environment).
  • the shunt 705 may be operated as a fluid heat source. Fluid may be circulated to introduce warmer fluid. Such examples may be configured and/or operated to warm the body cavity 620 and/or surrounding tissue, for example.
  • cooling brain tissue by as little as 2-3°F may reduce or cure epilepsy.
  • the shunt 705 may, for example, be configured and/or operated to treat brain trauma.
  • the shunt 705 may, for example, be configured and/or operated to treat epilepsy.
  • the shunt 705 may, for example, be configured and/or operated to treat meningitis.
  • the shunt 705 may, for example, be configured and/or operated for treat neuro-inflammation.
  • the shunt 705 may, for example, be configured and/or operated to treat Alzheimer’s.
  • the shunt 705 may provide at least a component of a brain-computer interface.
  • the shunt 705 may be configured and/or operated to deliver and/or to determine target (e.g., optimal) delivery times of therapeutic agents (e.g., locally, systemically, remote). In some examples, the shunt 705 may be configured and/or operated to treat hydrocephalus. In some examples, the shunt 705 may be used pre and/or post brain surgery. In some examples, the shunt 705 may be configured and/or operated for brain pacing (e.g., electrical pacing). In some examples, the shunt 705 may be configured and/or operated for limb state management.
  • target e.g., optimal delivery times of therapeutic agents
  • the shunt 705 may be configured and/or operated to treat hydrocephalus. In some examples, the shunt 705 may be used pre and/or post brain surgery. In some examples, the shunt 705 may be configured and/or operated for brain pacing (e.g., electrical pacing). In some examples, the shunt 705 may be configured and/
  • FIG. 8 depicts an illustrative vertebral access method, such as disclosed, for example, with respect to FIGS. 1-2.
  • a first vertebral body (VB) is accessed (step 805) via the corresponding pedicle.
  • a counter variable e.g., “i”, as depicted
  • a device e.g., catheter with steerable drill tip
  • Subsequent operation(s) may, for example, be performed (steps 830), as depicted (e.g., as described with respect to, by way of example and not limitation, FIGS. 1-4). [0107] FIG. 9 and FIG.
  • a counter variable i is initialized to 1 (step 905), and the ith body of a SBAD (e.g., 210 and/or 211) is disposed into an ith vertebral body (step 910).
  • the counter i is reinitialized to 1 (step 922), and the ith is operated (e.g., expanded, anchor(s) deployed) to couple to the corresponding ith vertebral body (step 930), and the counter incremented (step 930) and process repeated until the n SBAD bodies have been coupled (step 935).
  • only selected bodies e.g., m selected bodies ⁇ n selected bodies
  • bodies may, for example, be placed and/or coupled asynchronously (e.g., out of integer order).
  • a further step(s) may include coupling bodies together (e.g., stacking, fastening, such as 210 to 211)
  • control member(s) e.g., 220
  • step 940 e.g., tightened, pulled, expanded, loosened
  • all control members may be operated.
  • Control member(s) of selected SBADs may, for example, be operated (e.g., identically, differentially such as in different directions).
  • Step 940 may, for example, be repeated, as shown, until a target displacement is reached (step 945).
  • FIG. 10 depicts a method 1000 in which the ith body is operated to couple (step 925) directly after placing the ith body (step 910).
  • Some implementations may, for example, include additional steps such as, by way of example and not limitation: imaging; sensor reading such as pressure, force, shear, orientation; trajectory prediction; differential analysis to determine a difference between a pre-adjustment configuration, a post-adjustment configuration, and/or a predicted post-adjustment configuration.
  • the steerable catheter 120, structural reinforcement modules 210, stent 505, bladder 605, shunt 705, and/or associated devices may be connected to and/or configured according to one or more devices.
  • Example devices include those disclosed at least with reference to:
  • some bypass circuits implementations may be controlled in response to signals from analog or digital components, which may be discrete, integrated, or a combination of each.
  • Some embodiments may include programmed, programmable devices, or some combination thereof (e.g., PLAs, PLDs, ASICs, microcontroller, microprocessor), and may include one or more data stores (e.g., cell, register, block, page) that provide single or multi-level digital data storage capability, and which may be volatile, non-volatile, or some combination thereof.
  • Some control functions may be implemented in hardware, software, firmware, or a combination of any of them.
  • Computer program products may contain a set of instructions that, when executed by a processor device, cause the processor to perform prescribed functions. These functions may be performed in conjunction with controlled devices in operable communication with the processor.
  • Computer program products which may include software, may be stored in a data store tangibly embedded on a storage medium, such as an electronic, magnetic, or rotating storage device, and may be fixed or removable (e.g., hard disk, floppy disk, thumb drive, CD, DVD).
  • Temporary auxiliary energy inputs may be received, for example, from chargeable or single use batteries, which may enable use in portable or remote applications. Some embodiments may operate with other DC voltage sources, such as 9V (nominal) batteries, for example.
  • Alternating current (AC) inputs which may be provided, for example from a 50/60 Hz power port, or from a portable electric generator, may be received via a rectifier and appropriate scaling. Provision for AC (e.g., sine wave, square wave, triangular wave) inputs may include a line frequency transformer to provide voltage step-up, voltage step-down, and/or isolation.
  • one or more user-interface features may be custom configured to perform specific functions.
  • Various embodiments may be implemented in a computer system that includes a graphical user interface and/or an Internet browser. To provide for interaction with a user, some implementations may be implemented on a computer having a display device.
  • the display device may, for example, include an LED (light-emitting diode) display.
  • a display device may, for example, include a CRT (cathode ray tube).
  • a display device may include, for example, an LCD (liquid crystal display).
  • a display device (e.g., monitor) may, for example, be configured and/or operated for displaying information to the user.
  • Some implementations may, for example, include a keyboard and/or pointing device (e.g., mouse, trackpad, trackball joystick), such as by which the user can provide input to the computer.
  • the system may communicate using suitable communication methods, equipment, and techniques.
  • the system may communicate with compatible devices (e.g., devices capable of transferring data to and/or from the system) using point-to-point communication in which a message is transported directly from the source to the receiver over a dedicated physical link (e.g., fiber optic link, point-to-point wiring, daisy-chain).
  • the components of the system may exchange information by any form or medium of analog or digital data communication, including packet-based messages on a communication network.
  • Examples of communication networks include, e.g., a LAN (local area network), a WAN (wide area network), MAN (metropolitan area network), wireless and/or optical networks, the computers and networks forming the Internet, or some combination thereof.
  • Other implementations may transport messages by broadcasting to all or substantially all devices that are coupled together by a communication network, for example, by using omni-directional radio frequency (RF) signals.
  • RF radio frequency
  • Still other implementations may transport messages characterized by high directivity, such as RF signals transmitted using directional (i.e., narrow beam) antennas or infrared signals that may optionally be used with focusing optics.
  • USB 2.0 Firewire
  • ATA/IDE RS-232
  • RS-422 RS-485
  • 802.11 a/b/g Wi-Fi
  • Ethernet IrDA
  • FDDI fiber distributed data interface
  • token-ring networks multiplexing techniques based on frequency, time, or code division, or some combination thereof.
  • Some implementations may optionally incorporate features such as error checking and correction (ECC) for data integrity, or security measures, such as encryption (e.g., WEP) and password protection.
  • ECC error checking and correction
  • WEP Secure Digital
  • the techniques described herein relate to a skeletal body adjustment device, wherein the anchor is selectively operably from at least a stowage mode to a deployed mode, the deployed mode corresponding to coupling to the corresponding at least one skeletal body.
  • the techniques described herein relate to a skeletal body adjustment device, wherein the sensor includes at least one conductive lead coupled to and/or integrated into the anchor.
  • the techniques described herein relate to a skeletal body adjustment device, further including a controller operably coupled to selectively operate the at least one control member.
  • the techniques described herein relate to a skeletal body adjustment device, wherein the controller is operably coupled to a sensor coupled to at least one of the first body and the second body.
  • the techniques described herein relate to a skeletal body adjustment device, wherein the controller selectively operates the at least one control member based on input from at least one sensor.
  • the techniques described herein relate to a skeletal body adjustment device, further including a delivery mechanism.
  • the techniques described herein relate to a skeletal body adjustment device, further including at least a second of said anchor.
  • the techniques described herein relate to a method 1-16 such that the first body is disposed within the first vertebral body, and the second body is disposed within the second vertebral body; couple the first body to the first vertebral body; couple the second body to the second vertebral body; and, operate the control member such that at least one of the first body and the second body are displaced relative to each other such that corresponding displacement is induced in at least one of the first vertebral body and the second vertebral body.
  • the techniques described herein relate to a method, further including advancing a lead through and/or from the skeletal body adjustment device and into proximity to nerve tissue such that the lead is configured to monitor and/or stimulate the nerve tissue.
  • the techniques described herein relate to a body cavity engagement device, wherein at least one of the contact modules includes a sensor.
  • the techniques described herein relate to a body cavity engagement device, wherein at least one of the contact modules includes a conductive lead.
  • the techniques described herein relate to a body cavity engagement device, wherein at least one of the contact modules is configured as an anchor.
  • the techniques described herein relate to a body cavity engagement device, wherein at least one of the contact modules is selectively deployable in response to a signal from the controller.
  • the techniques described herein relate to a body cavity engagement device, configured and/or operated to treat at least one epilepsy, depression, and Parkinson's disease.
  • the techniques described herein relate to a bladder, wherein operating at least one of the outer layer and the inner layer from the stowage mode to the deployed mode includes providing a fluid such that the at least one of the outer layer and the inner layer are inflated.
  • the techniques described herein relate to a method, further including: retrieve fluid from the body cavity via the lumen.
  • CSF cerebrospinal fluid
  • a shunt configured to be implanted in a patient's body in fluid communication with CSF; sensors operably coupled to the shunt; a control module operatively connected to the sensors, the control module configured to adjust the operation of the shunt based on a at least one predetermined parameter; and, valves operatively connected to the control module and selectively operable by the control modules such that CSF flow is dynamically regulated.
  • the techniques described herein relate to a CSF shunt system, wherein the control module is configured to adjust the operation of the shunt remotely.
  • the techniques described herein relate to a CSF shunt system, wherein the sensors provide real-time data to the control module.
  • the techniques described herein relate to a CSF shunt control system, wherein the shunt is configured to be remotely adjusted by a healthcare provider via an interface with the control module.
  • the techniques described herein relate to a CSF shunt control system, wherein the predetermined parameters compise at least one of: pressure, flow rate, and/or CSF composition.

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Abstract

Dans certains modes de réalisation, un appareil et des procédés associés concernent un dispositif de réglage de corps squelettique (SBAD) avec des corps reliés de manière télescopique. Par exemple, le SBAD peut comprendre des éléments de commande conçus pour induire une translation relative entre les corps. Dans certains modes de réalisation, l'appareil et les procédés associés se rapportent à une dérivation conforme à la cavité corporelle. À titre d'exemple, la dérivation peut, par exemple, comprendre des éléments de contact déployables sélectivement. Les éléments de contact peuvent, à titre d'exemple et non limitatifs, être conçus sous la forme d'ancrages, de capteurs et/ou de dispositifs d'administration de thérapie. Dans certains modes de réalisation, l'appareil et les procédés associés concernent une vessie multicouche (MLB) déployable sélectivement dans une cavité corporelle. La MLB peut, par exemple, comprendre des composants de détection et/ou d'administration. La MLB peut, par exemple, également comprendre un ou plusieurs éléments de commande et/ou une ou plusieurs commandes de pression conçues pour commander la forme, la taille et/ou la pression de la MLB. Dans certains modes de réalisation, l'appareil et les procédés associés concernent un système de dérivation de liquide céphalorachidien (LCR) à commande dynamique.
PCT/US2024/051288 2023-10-13 2024-10-14 Dispositifs rachidiens et neurochirurgicaux Pending WO2025081167A1 (fr)

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US5336223A (en) * 1993-02-04 1994-08-09 Rogers Charles L Telescoping spinal fixator
US20090012564A1 (en) * 2007-03-07 2009-01-08 Spineworks Medical, Inc. Transdiscal interbody fusion device and method
US20090099609A1 (en) * 2007-10-11 2009-04-16 Zimmer Gmbh Bone anchor system
US20160220275A1 (en) * 2013-09-11 2016-08-04 Vexim Helical bone fixation device
WO2018071600A1 (fr) * 2016-10-11 2018-04-19 Cerevasc, Llc Méthodes et systèmes de traitement de l'hydrocéphalie
WO2018195406A1 (fr) * 2017-04-21 2018-10-25 Stryker Corporation Système de stabilisation et implant pour empêcher un mouvement relatif entre des sections de tissu
US10349982B2 (en) * 2011-11-01 2019-07-16 Nuvasive Specialized Orthopedics, Inc. Adjustable magnetic devices and methods of using same
EP3368137B1 (fr) * 2015-10-30 2021-03-03 CereVasc, Inc. Systèmes de traitement de l'hydrocéphalie
US11241257B2 (en) * 2008-10-13 2022-02-08 Nuvasive Specialized Orthopedics, Inc. Spinal distraction system

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5336223A (en) * 1993-02-04 1994-08-09 Rogers Charles L Telescoping spinal fixator
US20090012564A1 (en) * 2007-03-07 2009-01-08 Spineworks Medical, Inc. Transdiscal interbody fusion device and method
US20090099609A1 (en) * 2007-10-11 2009-04-16 Zimmer Gmbh Bone anchor system
US11241257B2 (en) * 2008-10-13 2022-02-08 Nuvasive Specialized Orthopedics, Inc. Spinal distraction system
US10349982B2 (en) * 2011-11-01 2019-07-16 Nuvasive Specialized Orthopedics, Inc. Adjustable magnetic devices and methods of using same
US20160220275A1 (en) * 2013-09-11 2016-08-04 Vexim Helical bone fixation device
EP3368137B1 (fr) * 2015-10-30 2021-03-03 CereVasc, Inc. Systèmes de traitement de l'hydrocéphalie
WO2018071600A1 (fr) * 2016-10-11 2018-04-19 Cerevasc, Llc Méthodes et systèmes de traitement de l'hydrocéphalie
WO2018195406A1 (fr) * 2017-04-21 2018-10-25 Stryker Corporation Système de stabilisation et implant pour empêcher un mouvement relatif entre des sections de tissu

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