Shunt insertion system and other embodiments

Abstract

A shunt insertion system comprises a positioning assembly, a driving assembly coupled with the positioning assembly, and a mounting assembly coupled with the driving assembly for the insertion of a catheter. The driving assembly is configured to drive a mounting assembly. The mounting assembly comprises a sensor configured to sense resistance and generate sensor data indicating the resistance.

Description

SHUNT INSERTION SYSTEM AND OTHER EMBODIMENTSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to and the benefit of the earlier filing of U.S. Provisional Application No. 63 / 675,207, filed on July 24, 2024, which is incorporated by reference herein in its entirety.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] This invention was made with government support under contract 2R01 NS094570-06A1 awarded by National Institutes of Health. The government has certain rights in the invention.FIELD OF THE DISCLOSURE

[0003] This disclosure relates to medical instruments and, more particularly, to shunt insertion systems.BACKGROUND OF THE DISCLOSURE

[0004] Hydrocephalus is an accumulation of cerebrospinal fluid (CSF) in the ventricles of the brain, often leading to heightened intracranial pressure (ICP) and long-term neurological deficits. The overwhelming majority of patients with this condition are treated with a surgical implantation of a shunt to drain excess CSF from the cerebral ventricles. However, a shocking 85% of the shunts fail. When the shunt system fails, the patient requires immediate shunt revision surgery to repair or replace failed shunt hardware (Harris etal., Neurosurgery. 70(6), 1589-1602, 2012). This failure rate is the dominant contributor to the $2 billion / year cost that hydrocephalus imposes on the US healthcare system (Harris et al., Neurosurgery. 70(6), 1589-1602, 2012).

[0005] The current process of shunt insertion is inconsistent and can lead to complications such as bleeding, inflammation, and injuries. These issues can trigger a rapid neuroinflammatory response and vascular reorganization, which not only persist throughout the shunt’s lifespan but also contribute to the cascade leading to device failure. Additionally, the insertion process can cause surrounding intact capillaries to lose their perfusion ability over time. Therefore, there is a pressing need to develop a catheter insertion technology that addresses these limitations.SUMMARY OF THE DISCLOSURE

[0006] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify allkey features or essential features of the claimed subject matter, nor is it intended to be used alone as an aid in determining the scope of the claimed subject matter.

[0007] The present disclosure provides a shunt insertion system, including a positioning assembly, a driving assembly coupled with the positioning assembly, and a mounting assembly coupled with the driving assembly. The driving assembly is configured to drive the mounting assembly to insert a catheter. In some aspects, the shunt insertion system is coupled with a navigation system such as an ultrasound device to guide the insertion of the catheter. The mounting assembly includes a sensor configured to sense resistance and generate sensor data indicating the resistance, providing feedback for the insertion of the catheter.

[0008] In some examples, the positioning assembly includes a platform, a handle, and a first mounting plate. The first mounting plate is configured to be coupled to the driving assembly.

[0009] In some examples, the driving assembly includes a push-pull assembly, an actuator, and a second mounting plate. The push-pull assembly is configured to be coupled to the mounting assembly and control movement of the mounting assembly. The actuator is configured to actuate the push-pull assembly. The second mounting plate is configured to be coupled to the first mounting plate of the positioning assembly.

[0010] In some examples, the actuator comprises at least one of an electric actuator, a hydraulic actuator, a piezoelectric actuator, or a mechanical actuator. In some examples, the actuator is a stepper motor.

[0011] In some examples, the shunt insertion system includes a controller, a processor, and a computing system. The controller is in communication with the sensor on the mounting assembly. The controller is configured to control the actuator. The controller is further configured to receive the sensor data and generate controller data based at least on the sensor data. The processor is in communication with the controller. The processor is configured to receive the controller data from the controller, process the controller data, and generate processed data. The computing system is in communication with the processor. The computing system is configured to receive the processed data, and generate commands for controlling the actuator.

[0012] In some examples, the controller is further configured to receive the commands from the computing system, generate instructions for controlling the actuator based at least on the commands, and transmit the instructions to the actuator.

[0013] In some examples, the mounting assembly includes a catheter support and a mounting arm. The catheter support is configured to support the catheter. The mounting arm is configured to be mounted to the driving assembly.

[0014] In some examples, the mounting assembly is further configured to support a catheter of a shunt to be inserted into tissues. In some examples, the catheter is configured to allow fluid flow therethrough. In some examples, the fluid comprises cerebrospinal fluid (CSF).

[0015] In some examples, the resistance is a force exerted on the catheter by the tissues.

[0016] In some examples, the sensor comprises a force gauge.

[0017] In some examples, the shunt insertion system further includes a safety feature configured to stop a movement of the shunt insertion system.

[0018] The present disclosure also provides a method for controlling a shunt insertion system. A sensor collects the sensor data and transmits the sensor data to a controller. The controller processes the sensor data to generate controller data based, at least in part, on the sensor data. The controller transmits the controller data to a processor. The processor processes the controller data to generate processed data based at least in part on the controller data. The processor transmits the processed data to a computing system. The computing system processes the processed data to generate commands based, at least in part, on the processed data. The computing system transmits the commands to the controller. The controller processes the commands to generate instructions based at least in part on the commands and transmits the instructions to an actuator. In some examples, the instructions comprise an instruction on the moving rate of the actuator such as a stepper motor.

[0019] The present disclosure provides a non-transitory computer-readable medium storing instructions that, when executed, cause one or more processors to perform the following operations. A sensor collects the sensor data and transmits the sensor data to a controller. The controller processes the sensor data to generate controller data based, at least in part, on the sensor data. The controller transmits the controller data to a processor. The processor processes the controller data to generate processed data based at least in part on the controller data. The processor transmits the processed data to a computing system. The computing system processes the processed data to generate commands based, at least in part, on the processed data. The computing system transmits the commands to the controller. The controller processes the commands to generate instructions based at least in part on the commands and transmits the instructions to an actuator.BRIEF DESCRIPTION OF DRAWINGS

[0020] The detailed description is set forth with reference to the accompanying figures. In the figures, the left-most digit(s) of a reference number identifies the figure in which the reference number first appears. The use of the same reference numbers in different figures indicates similaror identical items or features. Some of the drawings submitted herein may be better understood in color. Applicant considers the color versions of the drawings as part of the original submission and reserves the right to present color images of the drawings in later proceedings.

[0021] FIG. 1 A illustrates an exploded view of a shunt insertion system for inserting a catheter in accordance with implementations of this disclosure.

[0022] FIG. 1 B illustrates a positioning assembly for the shunt insertion system of FIG. 1 A in accordance with implementations of this disclosure.

[0023] FIG. 1C illustrates a driving assembly for the shunt insertion system of FIG. 1 A in accordance with implementations of this disclosure.

[0024] FIG. 1 D illustrates a cross-sectional view of the driving assembly of FIG. 1 C along line A- A’ in accordance with implementations of this disclosure.

[0025] FIG. 1 E illustrates a cross-sectional view of the push-pull assembly within the driving assembly cross-section A-A’ of FIG. 1 D in accordance with implementation of this disclosure.

[0026] FIG. 1 F illustrates a mounting assembly for the shunt insertion system of FIG. 1 A in accordance with implementations of this disclosure.

[0027] FIG. 1G illustrates an assembled shunt insertion system for inserting a catheter in accordance with implementations of this disclosure

[0028] FIG. 2 illustrates a process for controlling a shunt insertion system in accordance with implementations of this disclosure.

[0029] FIG. 3 illustrates a process for controlling a shunt insertion system in accordance with the implementations of this disclosure.

[0030] FIG. 4 illustrates a diagram showing accuracy of a shunt insertion system in accordance with implementations of this disclosure.

[0031] FIGs. 5A-5D illustrate cross-sections of rodent tissue (cortical layer VI) looking down on the inserted catheter such that the response can be observed radiating from the shunt-tissue interface. It can be seen that the vascular damage (FIG. 5A) and the quantity of macrophages / microglia (FIG. 5B) is higher at slower insertion in comparison to the vascular damage (FIG. 50) and macrophage / microglia quantity with faster insertion and high force (FIG. 5D) (scale bar =1 mm, shunt diameter = 2 mm).

[0032] FIGs. 6A and 6B are graphs quantifying the damage shown in FIGs. 5A-5D demonstrating that the vascular damage and the quantity of macrophages / microglia is lower at higher insertion with heightened observable maximum force suggesting that force from set insertion rates elicits quantifiable values of bleeding and inflammatory response.

[0033] FIG. 7 is a graph of clinician shunt insertion rate (y) as a function of distance through brain phantom (x). Variability is significant, ranging from 5-40 mm / s (average 10.3 mm / s).

[0034] FIG. 8 is graph of tissue damage area as a function of speed of insertion.

[0035] FIG. 9 is a graph of mean ranked blood accumulation in the tissue area around the device as a factor of speed.

[0036] FIG. 10 is a graph of vessel length in the tissue area around the device as a factor of speed.

[0037] FIG. 11 is a graph of the number of astrocytes stained positively for glial fibrillary acidic protein as a factor of speed.

[0038] FIG. 12 is a block diagram of a computing system for use with a shunt insertion system.DETAILED DESCRIPTION

[0039] Hydrocephalus, an imbalance between cerebrospinal fluid (CSF) production and absorption, is diagnosed in more than 1 in 500 people in the United States and arises from a variety of causes, including genetic diseases, meningitis, subarachnoid hemorrhage, stroke, traumatic brain injury, or tumors. Approximately 80% of these patients will suffer long-term neurological deficits.

[0040] The common treatment for hydrocephalus patients is implantation of a shunt to drain excess CSF. The shunt system is used to redirect excess CSF to a different area, typically the abdominal cavity. However, 85% of these shunts fail due in large part to the presence of blood, reactive inflammatory cells (including blood-borne macrophages and astrocytes) and coagulated blood. Reducing incoming inflammatory cells and their reactivity around the shunt as well as reducing bleeding from the trauma of shunt insertion is expected to decrease shunt failure.

[0041] Recent studies on neural implants have shown that injury from device insertion induces a rapid neuroinflammatory response and vascular reorganization that not only persists through the life of the implant, but perpetuates the cascade toward device failure (Biran, R., Martin, D. C. & Tresco, P. A. Neuronal cell loss accompanies the brain tissue response to chronically implanted silicon microelectrode arrays. Exp. Neurol. 195, 115-126 (2005); Kozai, T. D. Y., Vazquez, A. L., Weaver, C. L., Kim, S. G. & Cui, X. T. In vivo two-photon microscopy reveals immediate microglial reaction to implantation of microelectrode through extension of processes. J. Neural Eng. 9, 066001 (2012))). Multiphoton imaging studies show blood cells, plasma, and blood-borne macrophages (all foreign to the brain) are deposited from initial blood-brain barrier rupture with additional microhemorrhages observed in tissue. While some of these blood vessels clot within seconds, microhemorrhages have clearly been demonstrated to robustly contribute to chronicinjury in the tissue surrounding the device through adsorption of inflammation molecules from the blood and nearby cells in tissue including accumulation of microglia and macrophages at the device interface, oxidative stress and free radicals from the plasma, red blood cell breakdown, vasogenic brain edema and cytotoxic swelling. (Xi, G. etal. Mechanisms of edema formation after intracerebral hemorrhage: effects of extravasated red blood cells on blood flow and blood-brain barrier integrity. Stroke 32, 2932-2938 (2001); Jones, L. L., Yamaguchi, Y., Stallcup, W. B. & Tuszynski, M. H. NG2 is a major chondroitin sulfate proteoglycan produced after spinal cord injury and is expressed by macrophages and oligodendrocyte progenitors. J. Neurosci. 22, 2792-2803 (2002); Barzo, P., Marmarou, A., Fatouros, P., Hayasaki, K. & Corwin, F. Contribution of vasogenic and cellular edema to traumatic brain swelling measured by diffusion-weighted imaging. J. Neurosurg. 87, 900-907 (1997) ; 20. Kimelberg, H. K. Current concepts of brain edema. Review of laboratory investigations. J. Neurosurg. 83, 1051-1059 (1995)).

[0042] Current shunt insertion is conducted free-hand by a surgeon. During implantation, the shunt cuts through blood vessels, and cutting through even tiny vessels opens a pathway for blood factors that the brain tries to protect itself from. These factors include red blood cells, clotting factors, proteins, and inflammatory cells from other parts of the body. While much of this material clots, stopping the influx of blood factors, the damage is already done. Blood proteins may bind to the shunt catheter surface, blood clots on the shunt, and inflammatory cells may block the shunt holes. In a study explanted shunts from patients across North America, blood was found on 37% of failed shunts, and inflammatory blood-borne cells were found on 78% of failed shunts. Worse still, data indicate that microhemorrhages from device insertion never fully stop bleeding, allowing blood factors to continually reach the shunt through brain tissue and perpetuating the activation of inflammatory cells, leading to blockages.

[0043] Clinical data have shown that surgeons of all levels of expertise vary their manual insertion rate between patients, and the perceived optimal insertion rate is highly individualized to a specific neurosurgeon. Findings from 15 surgeons (45 samples in total plus an additional 3 staff collected as controls) indicate that neurosurgical attending physicians and residents vary their insertion rates from 5 to 40 mm / s, with a mean of 10.3 mm / s. Variability was observed over time, with surgeons inserting at different rates as they progressed deeper into the tissue. Additionally, there were significant differences between individual surgeons (5-40 mm / s range), and each neurosurgeon demonstrated inconsistency across the shunts they implanted (Kainz et al., Front Bioeng Biotechnol. 11 :1143304, 2023. doi: 10.3389 / fbioe.2023.1143304). This variability is not surprising as shunt catheters are implanted manually. However, this finding is significant, as preliminary data in our lab in a shunted rodent model shows clear evidence of shifts in the amountof bleeding and inflammation shifts as insertion rates vary from 6.5 to 29.6 mm / s (FIGs. 5A-5D, FIGs. 6A and 6B).

[0044] In view of the above, there is a need to develop a shunt insertion technology that provides more control over the insertion while minimizing bleeding and inflammation for each patient. In some aspects, such technology could insert the shunt at a controlled rate through each tissue layer, periventricular white matter, and into the ventricles, automatically stopping at the correct depth. In some aspects, the insertion system is capable of inserting a hydrocephalus cerebral catheter at specific set speeds without disrupting the current neurosurgical workflow. In some aspects, the rate and force may be adjusted based on tissue stiffness levels and adapt its speed accordingly.

[0045] Provided is a robotic-assisted shunt insertion system which may dynamically adjust the shunt insertion rate based on the force exerted on the shunt by the tissue it comes in contact with. The shunt insertion system enables the automation of the insertion process, leading to more consistent and reproducible results and reducing the variability associated with manual procedures. This precise control over the insertion process adapts to the unique conditions of each patient’s brain tissue, ultimately reducing the risk of complications and damage.

[0046] Using one or more sensors, the catheter insertion system described herein assesses tissue force many (e.g., millions of) times per second, ensuring high accuracy. The shunt insertion system controls the insertion rate of shunts using a catheter insertion system with force tailored to the patient’s specific tissue stiffness, which can vary with age, brain structure, tissue type, intracranial pressure, etc., and which adjusts automatically. Data collected during the insertion is specific to each patient, regardless of pathophysiological states such as high intracranial pressure (ICP) or changes in brain compliance, enabling a customized insertion process.

[0047] In some examples, the shunt insertion system can linearly actuate the catheter (e.g., using a stepper motor) with an insertion rate based on resistance-driven force (90%) and shear friction along the sides of the shunt catheter (10%). For instance, the shunt insertion system can adjust the insertion rate by 5 mm / s in as short as 14 milliseconds (2.8 milliseconds for every 1 mm / s shift in insertion rate).

[0048] The robotic-assisted shunt insertion system described herein allows the surgeon control over the insertion location while ensuring the shunt is inserted at a rate that reduces bleeding and inflammation for the specific patient on which the insertion is being carried out relative to traditional, manual methods of shunt insertion. The catheter insertion system described herein facilitates controlled insertion through each tissue layer, periventricular white matter, and into the ventricles, automatically stopping at the correct depth.

[0049] The system may (1 ) allow a constant or near constant rate of insertion to eliminate unnecessary variability as neurosurgeon residents train, (2) facilitate start / stop insertion, (3) be adjustable based on specific need, and (4) in dynamic mode, automatically adjust the insertion rate specific to each patient’s brain tissue (e.g., based at least in part on the pressure exerted by the tissue on the shunt as it is being inserted) and insertion depth. In the dynamic mode, the insertion rate automatic adjustment may be influenced by a data curve that details the rate(s) which elicits the least bleeding and inflammation in each cortical layer, through the ependyma, and into the ventricle.

[0050] In some aspects, the insertion system described herein can be combined with other technology that responds to cell and tissue infiltration chronically (shunt coatings, changes in shunt architecture), smart technologies (implanted shunt sensors, new valves, Anuncia, Rhaeos), or other Perpetual Science technologies (topographical modifications with drug elution for reducing shunt obstruction once the cells are already activated, smart valves for more physiologic treatment).

[0051] Aspects of the current disclosure are now described in additional detail, as follows: (I) Shunt insertion system; (II) Feedback mechanism used in the management of the insertion process; (III) How the system works; (IV) Processes; (V) Experiments; (VI) Kits; (VII) Example Clauses; and (VIII) Closing Paragraphs.(I) Shunt Insertion System

[0052] FIG. 1A illustrates an exploded view of a shunt insertion system 100 for inserting a catheter in accordance with the implementations of this disclosure. The shunt insertion system includes a positioning assembly 104, a driving assembly 106, and a mounting assembly 108. It should be understood that the shunt insertion system 100 described herein can be adapted to include more or fewer assemblies as needed. For instance, additional assemblies, components, or modules can be integrated into the system, or certain components can be omitted based on the requirements of various situations. In some examples, the assemblies (the positioning assembly 104, driving assembly 106, and the mounting assembly 108) can be 3D printed polylactic acid (PLA). In some other examples, the assemblies can be machined or cast, for example from stainless steel for antimicrobial and sterilizable characteristics.

[0053] The positioning assembly 104 as shown in more detail in FIG. 1 B, is configured to control the position of the driving assembly 106 shown in FIG. 1C, and the mounting assembly 108 as shown in FIG. 1 F, allowing for accurate positioning and insertion of the catheter 102 shown in FIG. 1 G.

[0054] Generally, when a ventricular catheter is inserted, a small incision is made according to anatomical landmarks. In some aspects, the incision is made at or near Kocher’s point. A burr hole is created and the surgeon can manipulate the handle 1 12 to advance the catheter tip into an appropriate pre-insertion position, allowing for adjustments and various operations during the medical procedure. The surgeon or the operator can use the handle 112 to control the positioning of the catheter 102 prior to the insertion after which point an automated system may take over. In some aspects, the system may be coordinated with an ultrasound guide to automatically adjust the positioning.

[0055] In some examples, the positioning assembly 104 is mounted to a gas-driven arm / gas swivel arm (not shown) which can be fixed to an operating table in an operating room. Alternatively, the gas-driven arm / gas swivel arm can be attached to a movable cart, allowing it to be transported between operating rooms for added utility and ease of use in surgical settings. It should be understood that the positioning assembly 104 described herein is exemplary rather than limiting. The shape and structure of the positioning assembly 104 are not restrictive, allowing for potential modifications and adaptations to suit various requirements.

[0056] The positioning assembly 104 includes an opening 160 at the back to receive the actuator 120 which will drive the push-pull assembly 128. A rod configured to connect the motor and the driving assembly will extend through the hole 168 in the first mounting plate 1 16 from which the driving assembly will extend as shown in more detail in FIG. 1G. The first mounting plate 116 is configured to be coupled to the driving assembly 106. Below the first mounting plate 1 16 is a curved arm 134 which will allow sufficient space for the driving assembly 106 connected to the first mounting plate 116 to function. A cradle 126 at an end of the arm 134 is configured to guide the second end 132 of the mounting assembly 108. The distal end of the cradle 126 descends in a vertical direction to join a wall 138 perpendicular to the arm 134. While the wall 138 is shown as a cross shaped structure, other shapes may also be used. A handle 112 adjacent a first side 144 of the wall 138 is configured to be manipulated by a user. Manipulation of the handle 112 actuates the driving assembly 106 attached to the first mounting plate 116, moving the mounting assembly 108 forwards and backwards and placing the catheter 102 in the catheter support 124 at the correct location for initiating the catheter insertion.

[0057] The first mounting plate 116 is configured to be coupled to the driving assembly 106, providing a stable and secure point of attachment for the driving assembly 106, ensuring that the driving assembly 106 remains firmly in place during the catheter insertion process. In some examples, the first mounting plate 116 includes features such as pre-drilled holes, slots, or clamps that facilitate the installation, adjustment, and removal of the driving assembly 106 formaintenance or replacement. In some examples, the first mounting plate 116 may allow for adjustments and customization of the position of the driving assembly 106 to accommodate different procedures, patient anatomies, or specific medical requirements.

[0058] As will be described in further detail with reference to FIG. 1 G, the platform 1 10 of the positioning assembly 104 is configured to support various components of the shunt insertion system 100, such as the mounting assembly 108, the catheter 102, the sensor mount 1 14, and so on. The platform 110 ensures that these components are properly aligned and supported. The platform 110 can provide a stable base for the catheter insertion, ensuring that the catheter remains steady during the procedure, allowing for precise and controlled catheter placement.

[0059] The driving assembly 106 as shown in more detail in FIG. 1 C is configured to drive the mounting assembly 108 and provide control over the movement of the mounting assembly 108. The driving assembly 106 may control the speed, direction, and force applied to the mounting assembly 108 and thereby the catheter support 124 and any catheter 102 contained within the catheter support 124. The driving assembly 106 includes a first end 130 and a second mounting plate 122 that connects to the first mounting plate 116 of the positioning assembly 104. The chassis 164 of the driving assembly 106 includes a linear groove 136 for the arm 142 of the mounting assembly 108. The linear rods 156 are fixed inside the chassis via the linear rod seats 162, and a screw attached to the actuator 120 passes through the two mounting plates and engages with the push-pull assembly 128. The chassis is closed on the second end 132 by a cap.

[0060] FIG. 1 D is a cross-section along line A-A’ of FIG. 1 C, of the workings of the driving assembly 106 looking down the assembly to the second mounting plate 122. The driving assembly 106 is attached to the actuator 120 through both the second mounting plate 122 and the first mounting plate 116 via fastenings placed within one or more openings 150. In some aspects, the fastenings may be brads, screws, welds, pins, and the like. The second mounting plate 122 is configured to be coupled to the first mounting plate 116 of the positioning assembly 104. The combination of the first mounting plate 116 and the second mounting plate 122 provides a stable and secure point of attachment for the driving assembly 106, ensuring that the driving assembly 106 is held firmly in place during the procedure, preventing unwanted movement. In some examples, the second mounting plate 122 can include features like pre-drilled holes, slots, or clamps that facilitate installation, adjustment, and removal of the driving system for maintenance or replacement. By ensuring that the driving assembly 106 is securely mounted and properly aligned, the second mounting plate 122 helps maintain a safe operating environment, reducing the risk of damage to the tissue. In some aspects, the driving assembly 106 can be integrated with a control system (as described in further detail below).

[0061] While the openings 150 are shown to be symmetrically placed, there may be more or fewer openings in the same or different patterns. A linear rail nut 152 along with linear rails threaded through the linear rail mounting holes 158 guides the push-pull assembly 128 that allows the arm 142 to move forward and backward along the positioning assembly 104 to properly position the catheter 102 in the groove 140 of the catheter support 124.

[0062] The push-pull assembly 128 is shown in more detail in FIG. 1 E with the arm 142 of the mounting assembly 108 shown at the top with the linear rail nut 152 surrounding an opening for the linear rail screw 154 and the push-pull assembly 128 attached via linear rail mounting holes 158. The linear rods 156 extend through the holes 168 in the push-pull assembly 128, guiding the push-pull assembly 128 as it actuates along the driving assembly.

[0063] By pushing the mounting assembly 108, the catheter 102 can be advanced into the desired anatomical location, and by pulling the mounting assembly 108, the catheter 102 can be withdrawn. The push-pull assembly 128 helps to translate force from the actuator 120 through the mounting assembly 108 to apply the appropriate amount of force to the catheter during insertion and retraction, minimizing the risk of injury to tissues or organs. Controlled movements can reduce the chances of complications such as inflammation and bleeding.

[0064] The actuator 120 generates and applies the necessary force to advance the push-pull assembly 128 to further drive the mounting assembly 108, carrying the catheter 102 in the catheter support 124 to insert through tissues, ensuring that the force is appropriate and consistent, minimizing the risk of damage or injury. In automated or semi-automated catheter insertion procedures, the actuator 120 enables the automation of the insertion process. This can lead to more consistent and reproducible results, reducing the variability associated with manual procedures. The actuator 120 can provide fine control over the movement of the catheter 102, allowing for precise adjustments in position, ensuring proper navigation through the body’s pathways and reaching the target area. The actuator 120 also allows for the regulation of insertion and retraction speeds, which can be significant for different stages of the procedure or different types of tissues. Examples of the actuator 120 can include, but are not limited to, electric actuators, hydraulic actuators, piezoelectric actuators, mechanical actuators, etc. As an example, the actuator 120 is a stepper motor which is used in order to linearly move the catheter 102 throughout the surgery.

[0065] The mounting assembly 108 as shown in more detail in FIG. 1 F is configured to hold the catheter 102. The mounting assembly 108 is further configured to be installed in the driving assembly 106 with the arm 142 attached to the push-pull assembly 128 shown in FIG. 1 E, and move forwards and backwards at the determined speed and with the appropriate pressure. Themounting assembly 108 allows for flexible positioning of the catheter 102, enabling the surgeon to adjust the catheter 102 to the optimal angle and position for insertion, accommodating different patient anatomies and surgical approaches.

[0066] The mounting assembly 108 includes an arm 142 with a push-pull assembly 128 at a first end and a catheter support 124 at a second, opposite end. While the mounting assembly 108 is shown with a ninety degree angle in the arm, any bend sufficient to place the catheter support 124 in contact with the platform 1 10 is sufficient. In some aspects the platform 110 may be placed higher on the wall 138 of the positioning assembly 104 which would change the angle and length of the arm 142. In some aspects, the mounting assembly 108 may include a sensor mount 1 14 containing one or more sensors on an end opposite the end of the arm 142 from the push-pull assembly 128. The sensor within the sensor mount 114 may be configured to sense the resistance experienced by the catheter 102 during the insertion of the catheter 102. Real-time feedback from the force sensor within the force sensor mount 114 allows for better control over the insertion process. By monitoring the force, the sensor helps prevent excessive force that could lead to complications such as injury to blood vessels and other tissues. It acts as a safeguard to ensure the procedure is performed safely. The shunt insertion system 100 can dynamically adjust the force being applied by the catheter 102 to maintain a safe and effective insertion process. This is helpful for ensuring that the catheter is inserted with the appropriate amount of pressure to avoid damaging tissues or causing unnecessary damage to the patient. As an example, the sensor in sensor mount 114 is a piezoelectric force gauge. For example, the sensor can include a diaphragm that is coupled to one end of the catheter to sense the force experienced by the other end (the tip end of the catheter inserted into tissues) of the catheter during the insertion procedure. The piezoelectric force gauge is reliable, inexpensive, and can be made with redundancy to improve reliability.

[0067] The catheter support 124 is configured to support the catheter 102. While other attachment mechanisms may be used to hold the catheter in place, in some aspects the catheter support 124 includes a groove 140 for the catheter. The catheter support 124 is configured to fix the catheter 102 in place and support the catheter 102 during the insertion procedure, ensuring that the catheter remains in the desired position and orientation. The catheter support 124 also helps align the catheter 102 properly with the insertion path, avoiding unnecessary tissue damage and ensuring that the catheter reaches the target area accurately. By providing a secure and stable pathway for the catheter 102, the catheter support 124 helps reduce the risk of accidental damage to the patient. The catheter support 124 ensures that the catheter 102 is inserted smoothly and with the appropriate amount of force.

[0068] The arm 142 is configured to be mounted to the driving assembly 106 via the push-pull assembly 128. In some examples, the push-pull assembly 128 can include features such as predrilled holes, slots, or clamps that facilitate the installation, adjustment, and removal of the mounting assembly 108 to the driving assembly 106.

[0069] An assembled shunt insertion system is shown in FIG. 1G, including the catheter 102 inserted in catheter support 124 of the mounting assembly 108. The mounting assembly 108 is attached to the driving assembly 106, which is attached to the positioning assembly 104.

[0070] Embodiments of the shunt insertion system further include a safety feature (not shown) configured to stop the movement of the shunt insertion system 100 immediately (like a treadmill) during the insertion procedure. As an example, the safety feature can be a Stop / Start button that a surgeon can hold and release. For example, the surgeon can hold the Stop / Start button while the catheter is being inserted and release the button to stop the insertion when the catheter reaches the ventricle. The Stop / Start button can be arranged in various positions, such as on the positioning assembly, on the handle, on an operational table (not shown).

[0071] In some examples, a custom user interface is developed to facilitate the interaction between a surgeon and the insertion system. An easily accessible “Stop / Start” button feature is embedded within the interface to allow for simple and immediate control over the shunt insertion system. When the “Stop / Start” button is triggered (being pressed or released), the insertion of the catheter will stop immediately. Additionally, the user interface includes a custom speed input option that can be easily adjusted when the “Stop / Start” button is selected. Such a feature could be, for example, incorporated into the catheter insertion system interface 1200.

[0072] The safety feature allows for precise control during insertion, aiding the surgeon or operator in achieving optimal placement of the device within the target area. Moreover, the safety feature can help the surgeon control the depth and position of the inserted catheter, ensuring that the catheter does not exceed a predetermined point. By controlling the insertion depth, the safety feature minimizes the risk of complications such as excessive bleeding, inflammation, or other trauma to sensitive areas. This enhances the overall control and safety of the procedure.(II) Feedback mechanism used in the management of the insertion process

[0073] The shunt insertion system is designed to include a feedback mechanism configured to collect real-time data and adjust the insertion process to ensure optimal outcomes. Specifically, the brain’s compliance changes with age, varies within different brain structures, and changes dynamically with hydrocephalus. When a shunt is inserted, a decrease in brain compliance (increase in brain stiffness) will increase resistance to shunt insertion. The shunt insertion systemmonitors the resistance and tissue stiffness encountered during the insertion of the shunt, for example through the sensors in sensor mount 114. Based on this data, the shunt insertion system automatically accounts for the change in brain compliance at a rate and with accuracy that the unaided human hand cannot achieve. The sensor can sense the tissue immediately surrounding the shunt catheter tip, and the feedback mechanism can adjust the insertion rate depending on the resistance that the catheter tip encounters, minimizing trauma, bleeding, and inflammation. This allows for more precise control over the insertion process in comparison to manual insertion and allows the system to adapt to an individual patient. In some aspects, this may reduce the risk of complications and improving the success rate of the shunt implantation. In some examples, the shunt insertion system can keep a constant insertion rate through the brain during shunt insertion. In some other examples, the shunt insertion system can change speeds during a procedure.

[0074] FIG. 2 illustrates a feedback mechanism 200 for controlling a shunt insertion system in accordance with the implementations of this disclosure. Referring to FIG. 2, the tip of the catheter is placed in position at 202. A sensor such as a sensor in sensor mount 114 detects the resistance encountered by the catheter at 204. While any type of force sensor, pressure sensor, or strain sensor may be used, , in some aspects the sensor is a piezoelectric force gauge. The sensor generates sensor data at 206. The generated sensor data is transmitted to the controller at 210. The transmitted sensor data is then processed by the controller or a separate processor at 212. The system then determines whether the catheter is encountering resistance with threshold amounts at 214. In some aspects, the speed, force and direction of the catheter may be controlled by an actuator. Actuators may be electric actuators, hydraulic actuators, piezoelectric actuators, mechanical actuators, etc. As an example, the actuator may be a stepper motor which is used in order to linearly move the catheter throughout the surgery.

[0075] In some aspects, the resistance encountered by the catheter is set with a threshold amounts. If the catheter detects resistance outside of threshold amounts, the actuator may receive instructions to adjust the force and rate of the catheter insertion or removal at 216 and sensor detection will continue. In some aspects, microadjustments may be made by the actuator, allowing for smooth and controlled movements. This helps in avoiding abrupt starts and stops, which can cause mechanical stress and reduce the risk of damage to the patient.

[0076] In automated or semi-automated catheter insertion procedures, the feedback mechanism 200 enables the automation of the insertion process. This can lead to more consistent and reproducible results, reducing the variability associated with manual procedures. The feedback mechanism can provide real-time data and adjust the insertion process to ensure optimal outcomes. In implementations, the sensor monitors the resistance and tissue stiffnessencountered during the insertion of the shunt. Based on the sensor data, the system dynamically adjusts the insertion speed to minimize trauma, bleeding, and inflammation. This allows for precise control over the insertion process, adapting to the unique conditions of each patient's brain tissue, ultimately reducing the risk of complications and damage.

[0077] The shunt insertion system described herein controls the insertion rate of shunts with the catheter insertion system. This technology tailors the insertion rate to the patient’s specific tissue stiffness, which can vary with age or intracranial pressure, and adjusts automatically. The catheter insertion system described herein supports neurosurgeons without interfering with any neuronavigation they use to find the optimal shunt placement.(Ill) Processes

[0078] FIG.3 illustrates a process 300 for controlling a shunt insertion system in accordance with the implementations of this disclosure. Referring to FIG. 3, process 300 includes the following operations.

[0079] At 302, operations include collecting sensor data by a sensor. For example, the sensor is a force gauge. As an example, the sensor data comprises information indicating resistance experienced by a catheter during the insertion. For example, the sensor can include a diaphragm that is coupled to one end of the catheter to sense the force experienced by the other end (the tip end of the catheter inserted into tissues) of the catheter during the insertion procedure.

[0080] At 304, operations include transmitting, by the sensor, the sensor data to a controller.

[0081] At 306, operations include processing, by the controller, the sensor data to generate controller data based at least in part on the sensor data. As an example, an embodiment of the controller 304 can be SKR Mini E3 V3 - TMC2209. It should be understood that other types of controllers can also be implemented herein.

[0082] At 308, operations include transmitting, by the controller, the controller data to a processor.

[0083] At 310, operations include processing, by the processor, the controller data to generate processed data based at least in part on the controller data.

[0084] At 312, operations include transmitting, by the processor, the processed data to a computing system.

[0085] At 314, operations include processing, by the computing system, the processed data to generate commands based at least in part on the processed data.

[0086] At 316, operations include transmitting, by the computing system, the commands to the controller.

[0087] At 318, operations include processing, by the controller, the commands to generate instructions based at least in part on the commands.

[0088] At 320, operations include transmitting the instructions to an actuator. For example, the actuator can be one of an electric actuator, a hydraulic actuator, a piezoelectric actuator, or a mechanical actuator. As an example, the actuator is a stepper motor. As an example, the instructions comprise an instruction on the moving rate of the step motor.

[0089] Further, the processes discussed herein such as the processes of FIG. 2 and FIG. 3 may be implemented in hardware, software, or a combination thereof. In the context of software, the described operations represent computer-executable instructions stored on one or more computer-readable storage media that, when executed by one or more hardware processors, perform the recited operations. Generally, computer-executable instructions include routines, programs, objects, components, data structures, and the like that perform particular functions or implement particular abstract data types. Those having ordinary skills in the art will readily recognize that certain steps or operations illustrated in the figures above may be eliminated, combined, or performed in an alternate order. Any steps or operations may be performed serially or in parallel (unless the context requires one or the other). Furthermore, the order in which the operations are described is not intended to be construed as a limitation.

[0090] Embodiments may be provided as a software program or computer program product, including a non-transitory computer-readable storage medium having stored thereon instructions (in compressed or uncompressed form) that may be used to program a computer (or other electronic device) to perform processes or methods described herein. The computer-readable storage medium may be one or more of an electronic storage medium, a magnetic storage medium, an optical storage medium, a quantum storage medium, and so forth. For example, the computer-readable storage media may include but is not limited to, hard drives, floppy diskettes, optical disks, read-only memories (ROMs), random access memories (RAMs), erasable programmable ROMs (EPROMs), electrically erasable programmable ROMs (EEPROMs), flash memory, magnetic or optical cards, solid-state memory devices, or other types of physical media suitable for storing electronic instructions. Further, embodiments may also be provided as computer program products, including a transitory machine-readable signal (in compressed or uncompressed form). Examples of machine-readable signals, whether modulated using a carrier or unmodulated, include, but are not limited to, signals that a computer system or machine hosting or running a computer program can be configured to access, including signals transferred by one or more networks. For example, the transitory machine-readable signal may comprise the transmission of software by the Internet.

[0091] Separate instances of these programs can be executed on or distributed across any number of separate computer systems. Thus, although certain steps have been described as being performed by certain devices, software programs, processes, or entities, this need not be the case, and a variety of alternative implementations is understood by those having ordinary skills in the art.

[0092] FIG. 12 illustrates a system 1200 including a catheter insertion system interface 1202 and external devices 1222 configured to perform various functions described herein. For example, the catheter insertion system interface 1202 and / or the external devices 1222 may be configured to execute the processes of FIG. 2 and FIG. 3, receiving information from and providing instructions to the shunt insertion system 100. In various implementations, the operation of the shunt insertion system 100 may be controlled by at least one processor 1212. The processor(s) is configured to analyze the signals from the sensor(s) in the sensor mount 114 to determine the amount of resistance received when the catheter engages with the brain tissue.

[0093] In various implementations, the catheter insertion system interface 1202 includes at least one transceiver 1210 configured to communicate with at least one external device 1222 over one or more communication networks 1214. Any communication network described herein can be included in the communication network(s) 1214 illustrated in FIG. 12. The external device(s) 1222, for example, includes at least one of a monitor, a mobile phone, a server, or a computing device. In some implementations, the transceiver(s) 1210 is configured to communicate with the external device(s) 1222 by transmitting and / or receiving signals in a wired fashion and / or wirelessly. For example, the transceiver(s) 1210 includes a NIC, a network adapter, a LAN adapter, or a physical, virtual, or logical address to connect to the various external devices and / or systems. In various examples, the transceiver(s) 1210 includes any sort of wireless transceivers capable of engaging in wireless communication (e.g., RF communication). For example, the communication network(s) 1214 includes one or more wireless networks that include a 3GPP network, such as an LTE RAN (e.g., over one or more LTE bands), an NR RAN (e.g., over one or more NR bands), or a combination thereof. In some cases, the transceiver(s) 1210 includes other wireless modems, such as a modem for engaging in WI-FI®, WIGIG®, WIMAX®, BLUETOOTH®, or infrared communication over the communication network(s) 1214. The signals, in various cases, encode data in the form of data packets, datagrams, or the like.

[0094] In various cases, the processor(s) 1212 generates commands for the movement of the mounting assembly 108 via the driving assembly 106 based on signals received from the sensors in the sensor mount 114. According to some examples, the input device(s) 1206 receives information from one or more sensors. The sensor(s), for example, is configured to detectresistance encountered by the catheter 102. The catheter insertion system interface 1202 further includes at least one output device 1208, in various implementations. Examples of the output device(s) 1208 include, for instance, at least one of a display (e.g., a projector, an LED screen, etc.), a speaker, a haptic output device, a printer, a light such as an LED, or any combination thereof. In some implementations, the output device(s) 1208 include a screen configured to display various parameters detected by and / or reported to the catheter insertion system interface 1202.

[0095] The catheter insertion system interface 1200 further includes memory / storage component 1204 and a force history 1226 stored in computer readable media 1224. The computer readable media 1224 is illustrated as including memory / storage component 1204. The memory / storage component 1204 represents memory / storage capacity associated with one or more computer- readable media. The memory / storage component 1204 may include volatile media (such as random access memory (RAM)) and / or nonvolatile media (such as read-only memory (ROM), Flash memory, optical disks, magnetic disks, and so forth). The memory / storage component 1204 may include fixed media (e.g., RAM, ROM, a fixed hard drive, and so on) as well as removable media (e.g., Flash memory, a removable hard drive, an optical disc, and so forth). The computer- readable media 1224 may be configured in a variety of other ways as further described below. The force history 1126 may store historic measurements for a specific surgery, specific surgeon, or specific set of surgery or surgeons.

[0096] The memory / storage component 1204 stores instructions that, when executed by the processor(s) 1212, causes the processor(s) 1212 to perform various operations such as the operations detailed in FIG. 2 and FIG. 3 among others. In various examples, the memory / storage component 1204 stores methods, threads, processes, applications, objects, modules, any other sort of executable instruction, or a combination thereof. In some cases, the memory / storage component 1204 stores files, databases, or a combination thereof. In various cases, the memory / storage component 1204 stores instructions, programs, threads, objects, data, or any combination thereof, that cause the processor(s) 1212 to perform various functions. In various cases, the memory / storage component 1204 stores one or more parameters that are detected by the catheter insertion system interface 1202 and / or reported to the catheter insertion system interface 1202.

[0097] Additionally, those having ordinary skills in the art readily recognize that the techniques described above can be utilized in a variety of devices, environments, and situations. Although the subject matter has been described in language specific to structural features or methodological acts, it is to be understood that the subject matter defined in the appended claimsis not necessarily limited to the specific features or acts described. Rather, the specific features and acts are disclosed as exemplary forms of implementing the claims.

[0098] Those of ordinary skill in the art will recognize in light of the present disclosure that many changes can be made to the specific embodiments disclosed herein and still obtain a like or similar result without departing from the spirit and scope of the disclosure.(VI) Kits

[0099] Also provided are kits useful for treating hydrocephalus patients. An example of the kit includes one or more: a wearable device, a shunt valve that can be sterile and vacuum sealed, and a lithium battery pack which is sterile, and vacuum sealed.

[0100] More generally, kits can include instructions, for example, written instructions, on how to use the material(s) therein. Material(s) can be, for example, any substance, composition, polynucleotide, solution, etc., herein or in any patent, patent application publication, reference, or article that is incorporated by reference.

[0101] A kit can include a device as described herein, and optionally additional components such as buffers, reagents, and instructions for carrying out the methods described herein. The choice of buffers and reagents will depend on the particular application, e.g., the setting of the assay (point-of-care, research, clinical), analyte(s) to be assayed, the detection moiety used, the detection system used, etc.

[0102] The kit can also include informational material, which can be descriptive, instructional, marketing, or other material that relates to the methods described herein and / or the use of the devices for the methods described herein. In embodiments, the informational material can include information about the production of the device, physical properties of the device, date of expiration, batch or production site information, and so forth.(VII) Example Clauses

[0103] A: A shunt insertion system comprising: a positioning assembly; a driving assembly coupled with the positioning assembly, the driving assembly being configured to drive a mounting assembly; and the mounting assembly coupled with the driving assembly, wherein the mounting assembly comprises a sensor configured to sense resistance and generate sensor data indicating the resistance.

[0104] B: The shunt insertion system of paragraph A, wherein the positioning assembly comprises: a platform; a handle; and a first mounting plate configured to be coupled to the driving assembly.

[0105] C: The shunt insertion system of paragraph B, wherein the driving assembly comprises: a push-pull assembly configured to be coupled to the mounting assembly and control movement of the mounting assembly; an actuator configured to actuate the push-pull assembly; and a second mounting plate configured to be coupled to the first mounting plate of the positioning assembly.

[0106] D: The shunt insertion system of paragraph C, wherein the actuator comprises at least one of an electric actuator, a hydraulic actuator, a piezoelectric actuator, and a mechanical actuator.

[0107] E: The shunt insertion system of either paragraph C or D, wherein the actuator is a stepper motor.

[0108] F: The shunt insertion system of any one of paragraphs C-E, further comprising: a controller in communication with the sensor, the controller being configured to control the actuator, the controller further being configured to receive the sensor data and generate controller data based at least on the sensor data; a processor in communication with the controller, the processor being configured to receive the controller data from the controller, and process the controller data, and generate processed data; and a computing system in communication with the processor, the computing system being configured to receive the processed data, and generate commands for controlling the actuator.

[0109] G: The shunt insertion system of paragraph F, wherein the controller is further configured to receive the commands from the computing system, and generate instructions for controlling the actuator based at least on the commands, and transmit the instructions to the actuator.

[0110] H: The shunt insertion system of any one of paragraphs A-G, wherein the mounting assembly comprises: a catheter support configured to support the catheter; and a mounting arm configured to be mounted to the driving assembly.

[0111] I : The shunt insertion system of any one of paragraphs A-H, wherein the mounting assembly is further configured to support a catheter of a shunt to be inserted into tissues.

[0112] J: The shunt insertion system of paragraph I, wherein the catheter is configured to allow fluid flow therethrough.

[0113] K: The shunt insertion system of paragraph J, wherein the fluid comprises cerebrospinal fluid (CSF).

[0114] L: The shunt insertion system of either paragraph J or K, wherein the resistance is a force exerted on the catheter by the tissues.

[0115] M: The shunt insertion system of any one of paragraphs A-L, wherein the sensor comprises a force gauge.

[0116] N: The shunt insertion system of any one of paragraphs A-M further comprising a safety feature configured to stop a movement of the shunt insertion system.

[0117] 0: A method for controlling a shunt insertion system, the method comprising: collecting sensor data by a sensor; transmitting, by the sensor, the sensor data to a controller; processing, by the controller, the sensor data to generate controller data based at least in part on the sensor data; transmitting, by the controller, the controller data to a processor; processing, by the processor, the controller data to generate processed data based at least in part on the controller data; transmitting, by the processor, the processed data to a computing system; processing, by the computing system, the processed data to generate commands based at least in part on the processed data; transmitting, by the computing system, the commands to the controller; processing, by the controller the commands to generate instructions based at least in part on the commands; and transmitting the instructions to an actuator.

[0118] P: The method of paragraph 0, wherein the actuator comprises at least one of an electric actuator, a hydraulic actuator, a piezoelectric actuator, and a mechanical actuator.

[0119] Q: The method of either paragraph 0 or P, wherein the actuator is a stepper motor.

[0120] R: The method of paragraph Q, wherein the instructions comprise an instruction on moving rate of the stepper motor.

[0121] S: The method of any one of paragraphs O-R, wherein the sensor is a force gauge.

[0122] T: The method of paragraph S, wherein the sensor data comprises information indicating resistance experienced by a catheter during the insertion.

[0123] U: A non-transitory computer-readable medium storing instructions that, when executed, cause one or more processors to perform operations comprising: collecting sensor data by a sensor; transmitting, by the sensor, the sensor data to a controller; processing, by the controller, the sensor data to generate controller data based at least in part on the sensor data; transmitting, by the controller, the controller data to a processor; processing, by the processor, the controller data to generate processed data based at least in part on the controller data; transmitting, by the processor, the processed data to a computing system; processing, by the computing system, the processed data to generate commands based at least in part on the processed data; transmitting, by the computing system, the commands to the controller; processing, by the controller the commands to generate instructions based at least in part on the commands; and transmitting the instructions to an actuator.

[0124] While the example clauses described above are described with respect to one particular implementation, it should be understood that, in the context of this document, the content of theexample clauses can also be implemented via a method, device, system, a computer-readable medium, and / or another implementation.

[0125] The processes are illustrated as logical flowgraphs, which represent sequences of operations that can be implemented in hardware, software, or a combination thereof. In the context of software, the blocks represent computer executable instructions stored on one or more computer-readable storage media that, when executed by processor(s), perform the recited operations. Generally, computer-executable instructions include routines, programs, objects, components, data structures, and the like that perform particular functions or implement particular abstract data types. The order in which the operations are described is not intended to be construed as a limitation, and any number of the described operations can be combined in any order and / or in parallel to implement the processes. In some embodiments, one or more operations of the process can be omitted entirely. Moreover, the processes can be combined in whole or in part with each other or with other processes.(VII) Examples

[0126] The data was statistically correlated against itself or against a standard freeform shunt. Experiments in animals were designed to avoid confounding variables (e.g., veterinary prescribed antibiotics) that may influence the use of multinomial logistic regression in Statistical Package for the Social Sciences (SPSS). Benchtop models rely on standard parametric and non-parametric tests (t-test, F-test, Wilcoxon Signed Rank, multivariate factor analysis) to show statistical significance (P < 0.05) following tests for normalcy and data homoscedasticity. Post-hoc Tukey tests were used to compare individual parameters. The Pearson Correlation Test was performed for correlational analysis to attain p value and R2. It will allow researchers to effortlessly identify interesting and unusual patterns in data, both within each sample, across samples, and across experimental arms in all benchtop models. Researchers’ methods are well equipped to handle large datasets. Preliminary data were inserted into SPSS from at least n=5 for each benchtop model and pig data set. Ordered correlations were calculated using Pearson’s correlation test run and paired two-sample statistical tests. The principal component analysis was performed to correlate dependent variables. These data suggest that a relatively low sample size can be employed for each benchtop variable inputted into the system, and the number of groups analyzed can be increased. Sample size calculations on these data imply an average of 5.3 ± 4.7 samples in each sub-group to attain <20% beta error. The numbers for in vivo animal work are similar, with an n=5 for a projected 4 per group.Variability in shunt insertion in humans

[0127] An IRB was completed, and data were collected from 15 surgeons with triplicates (45 samples collected overall, with 3 additional staff collected as controls). Video capture analysis for insertion rates were analyzed following insertion into a PVA-phytagel brain phantom, cited in the literature as having nearly identical mechanical responses to human brain22 (Fig 3). We found that neurosurgical attending physicians and residents vary their insertion rate from 5-40 mm / s (mean 10.3 mm / s, Fig 3). There is variability over time (surgeons insert at different rates as they get deeper into tissue), different rates surgeon to surgeon (5-40 mm / s range), and different rates by the same surgeons for each implant as shown in FIG. 7.Data in Rodents

[0128] A steady-state insertion rate into rat cortex, through periventricular white matter, and into the ventricles with clinically relevant shunt insertion rates. As shown in FIG. 8, the average speed at which a neurosurgeon inserted a catheter, the lower quartile rate at which a neurosurgeon inserted a catheter, the upper quartile rate at which a neurosurgeon inserted a catheter; and the maximum average speed at which a neurosurgeon inserted a catheter was determined (see next, Quartile 1 : 6.5 mm / s, Average: 10.3 mm / s, Quartile 3: 10.3 mm / s, and the average of surgeons’ maxima: 29.6 mm / s) was used.

[0129] Preliminary data comparing Q1 6.5 mm / s and average of maxima 29.6 mm / s is presented here: compared to 29.6 mm / s, 6.5 mm / s had less tissue disruption, that is a smaller area of tissue damage (FIG. 8); less bleeding, even when normalized for tissue contact area (FIG. 9); less ruptured blood vessels in the microenvironment around the shunt (FIG. 10); and less force on the tissue. Microglia / macrophage response was less at 6.5 mm / s when normalized. Separately, in short-term live cell tracking of microglia / macrophages immediately following shunt insertion, we also found that increasing speed from 1 to 10 mm / s decreased live cell migration to the shunt and cell activation (unpublished data from Harris lab, WSU). These data suggest that there is a reduction in bleeding and inflammation around the shunt when rates are faster than 1 mm / s but slower than 29.6 mm / s (FIGs. 5A-6B). These data suggest that force on tissue from set insertion rates elicit quantifiable volumes of bleeding and inflammatory response (scale bar = 1 mm, and shunt diameter = 2 mm). However, while a slower insertion rate yields a smaller damage area but this is not linear with rate. These data suggest the need for further exploration, especially following device implantation for longer time periods to directly indicate relevance to shunt obstruction. We do see variances in speed creating a change in tissue damage area including the hole appearing more compact (perhaps a likelihood of tissue collapse around the insertion site after removal), more blood presence, increased vessel length, and increased astrocytic response observed in the lowest insertion speeds. Slower rates also yield a lower insertion force spike effectivelyincreasing mean effective tissue strain. This compares to other groups that have suggested that lower insertion rates increase vascular and tissue damage. These data highlight the need to study and maintain idealized insertion speed throughout the depth of the tissue into the lateral ventricles.Data in Pigs

[0130] There are several gyrencephalic animal models that have been used in hydrocephalus including dogs, cats (Eskandari et al., Childs Nerv Syst 27, 2067-2076, 2011 ), pigs (Mcallister et al., 2Fluids Barriers CNS 18, 2021 ), sheep, ferrets, and non-human primates. Pigs are preferred as a pre-clinical model because of their anatomical and physiological similarities to humans including their gyral patterns, a 60:40 white-to-gray matter ratio, and comparable brain growth and development timeline (with maximum brain growth occurring from late prenatal to early postnatal periods in both domestic pigs and humans). The size of the pig brain, even at juvenile stages, allows for shunting using clinical hardware available commercially. In future work, juvenile pigs are suitable for inducing hydrocephalus through intracisternal kaolin injections or intraventricular blood injections, of which the team has experience (Eskandari, 2011 ; Mcallister 2021 ; Garcia-Bonilla et al., J. Neurosurg. 140, 627-638, 2023). Additionally, the stereotactic coordinates of the pig brain are well documented.

[0131] Short (30 day) and long (180 day) response to shunt catheters are tested in juvenile domestic pigs across two cohorts: variable rate-controlled insertion using the shunt insertion system, and trained neurosurgeon-led free-hand insertion. Using a stereotactic head frame to guide location, commercial grade standard shunt catheters are inserted (e.g., Medtronic). An anterior insertion path is used, with trajectory originating from Kocher’s point. Images will be taken, and bleeding (immunofluorescent tomato lectin labeling), macrophages / microglia count and activity (immunofluorescent CD68 labeling), and astrocytes (immunofluorescent GFAP labeling) quantified as an indirect measure of shunt survival, since bleeding and infiltration of astrocytes and macrophages are keys to shunt failure. As done in preliminary data collection in rodents, properties surrounding the shunt catheter (as a function of distance, as a function of depth from the pial surface, and as a function of brain region) and in and on the shunt catheter will be analyzed, to assess cell attachment. In doing so, the overarching theory that the shunt insertion system improves shunt survival is tested. Specifically, this is accomplished through sequential cross-sectional cutting through the shunt insertion path to allow us to quantify the response as a function of depth into tissue and distance from the shunt-tissue interface. A secondary outcome measure of animal survival time is used, as appropriate.Shunt insertion system in patients with increased ventricular intracranial pressure.

[0132] Increase intracranial pressure with bolus infusions to shift compliance in hydrocephalicrelevant pressures to test how the shunt insertion system works in patients with increased ventricular ICP, as many patients either be first-time shunted or being revised under conditions which would indicate shunt failure and a potential rise in ventriculomegaly and / or ICP. In a nonsurvival large animal pig model, we infuse saline at set volumes (Kazimierska et al., Acta Neurochir. (Wien). 163, 1979-1989, 2021 ; Schmid Daners et al., IEEE Trans Biomed Eng 59, 3482-3490, 2012; Schmid Daners et al., PLoS One 7, e37502, 2012; Gehlen et al., IEEE Trans. Biomed. Eng. 63, 348-358, 2016), and then insert the shunt with the shunt insertion system set in “Constant Mode”. This determines how the shunt insertion system performs in patients with pre-existing pathophysiology caused by ICP, but also account for changes in compliance (e.g., intra-cortical vasculature pressure) (Kazimierska, 2021 ). Measurable outcomes include immunofluorescent labeling for bleeding and inflammatory cell activation. An important additional measurable outcome is force gauge data, similar to that which is illustrated in FIGs. 5A-5D and 6A-6B. The inserter is tested in a rodent model, where the shunt is inserted through the cortex, periventricular white matter, and into the lateral ventricle of both hemispheres of adult rodents. Quantitative analyses are performed on vasculature, macrophage / microglia response, astrocyte response, and nuclei. FIGs. 5A-5D and 6A-6B shows the expectation of how variance in tissue impacted the force observed by the shunt insertion system device. Set insertion rates and the biological response at heightened ICP and compliance can be compared compare across groups.Software

[0133] Software development includes the creation of a user interface but also hard code the data relationships that create “Dynamic Mode.” Preliminary in vivo data maps the bleeding response and inflammatory cell activation as a function at set constant insertion rates (FIGs. 5A-5D). But because the force required to push the shunt catheter in at these same constant insertion rates was measured in these same animals (FIGs. 5A-5D), the software then correlates bleeding response and inflammatory cell activation to the force required to push in the shunt catheter at any insertion rate, at any tissue plane. This serves as the basis for the functions driving the shunt insertion system “Dynamic Mode.” As an example, the “Dynamic Mode” uses live data from a piezoelectric sensor, which is then translated via coded identifiers from the data to show optimal insertion rates for minimal bleeding and inflammation based on the detected tissue stiffness. Additional analysis of rodent data obtained in this experiment is useful to accurately identify minimal bleeding and inflammatory cell activation through the entire shunt insertion path. These data then can then be augmented by large animal data for improved data confidence.Accuracy of system

[0134] An animal gelatin-based brain tissue mimic is utilized in conjunction with a custom imaging setup calibrated to measure catheter insertion rates from the device without distortion. Insertion rates are measured over a total travel distance of 50 mm through the brain tissue mimic, with a speed range of 0-30 mm / s at 5 mm / s intervals. The insertion speed is quantified and assessed. Data curves are generated via in-vivo data for further analysis.

[0135] Using the Shunt insertion system of FIG. 1 G may decrease tissue displacement, decrease bleeding, and decrease the likelihood of inflammatory cells becoming activated at the interface with the shunt - which, taken together, will lead to reduced shunt obstruction and shunt failure without changing anything about the implanted shunt itself.

[0136] FIG. 4 is a graph 400 illustrating the accuracy of the shunt insertion system 100 in “constant mode” set to known insertion rates for testing and validation. In FIG. 4, the horizontal axis represents the distance traveled in millimeters (mm), and the vertical axis represents the velocity in millimeters per second (mm / s). Curve 402 illustrates the velocity when the distance traveled is 25 mm. Curve 404 illustrates the velocity when the distance traveled is 20 mm. Curve 406 illustrates the velocity when the distance traveled is 15 mm. Curve 408 illustrates the velocity when the distance traveled is 10 mm. Curve 410 illustrates the velocity when the distance traveled is 5 mm. Curve 412 illustrates the velocity when the distance traveled is 1 mm. In the “constant mode,” set to known insertion rates for testing and validation, the shunt insertion system 100 outputs minimal side-to-side displacement and maintains a consistent velocity. This consistency is observed regardless of the distance traveled through the brain phantom, indicating that the catheter’s movement can be safely controlled.(VIII) Closing Paragraphs

[0137] Specific descriptions provided herein and in the herewith filed documents are included to demonstrate particular embodiments of the disclosure. Those of ordinary skill in the art should recognize in light of the present disclosure that many changes can be made to the specific embodiments disclosed herein and still obtain a like or similar result without departing from the spirit and scope of the disclosure.

[0138] As is understood by one of ordinary skill in the art, each embodiment disclosed herein can comprise, consist essentially of or consist of its particular stated element, step, ingredient or component. Thus, the terms “include” or “including” should be interpreted to recite: “comprise, consist of, or consist essentially of.” The transition term “comprise” or “comprises” means includes, but is not limited to, and allows for the inclusion of unspecified elements, steps, ingredients, or components, even in major amounts. The transitional phrase “consisting of”excludes any element, step, ingredient, or component not specified. The transition phrase “consisting essentially of” limits the scope of the embodiment to the specified elements, steps, ingredients or components and to those that do not materially affect the embodiment.

[0139] Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. When further clarity is required, the term “about” has the meaning reasonably ascribed to it by a person skilled in the art when used in conjunction with a stated numerical value or range, i.e. denoting somewhat more or somewhat less than the stated value or range, to within a range of ±20% of the stated value; ±19% of the stated value; ±18% of the stated value; ±17% of the stated value; ±16% of the stated value; ±15% of the stated value; ±14% of the stated value; ±13% of the stated value; ±12% of the stated value; ±11% of the stated value; ±10% of the stated value; ±9% of the stated value; ±8% of the stated value; ±7% of the stated value; ±6% of the stated value; ±5% of the stated value; ±4% of the stated value; ±3% of the stated value; ±2% of the stated value; or ±1% of the stated value.

[0140] Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0141] The terms “a,” “an,” “the” and similar referents used in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate theinvention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0142] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

[0143] Certain embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

[0144] Furthermore, numerous references have been made to patents, printed publications, journal articles, other written text, and web site content throughout this specification (referenced materials herein). Each of the referenced materials is individually incorporated herein by reference in their entirety for their referenced teaching(s), as of the filing date of the first application in the priority chain in which the specific reference was included. For instance, with regard to chemical compounds, nucleic acid, and amino acids sequences referenced herein that are available in a public database, the information in the database entry is incorporated herein by reference as of the date of an application in the priority chain in which the database identifier for that compound or sequence was first included in the text.

[0145] It is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.

[0146] The particulars shown herein are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of various embodiments of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for the fundamental understanding of the invention, the description taken with the drawings and / or examples making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

[0147] Definitions and explanations used in the present disclosure are meant and intended to be controlling in any future construction unless clearly and unambiguously modified in the example(s) or when application of the meaning renders any construction meaningless or essentially meaningless. In cases where the construction of the term would render it meaningless or essentially meaningless, the definition should be taken from Webster’s Dictionary, 3rd Edition, or a dictionary known to those of ordinary skill in the art, such as the Oxford Dictionary of Biochemistry and Molecular Biology (Ed. Anthony Smith, Oxford University Press, Oxford, 2004).

Claims

LISTING OF CLAIMSWhat is claimed is:1 . A shunt insertion system comprising: a positioning assembly; a driving assembly coupled with the positioning assembly, the driving assembly being configured to drive a mounting assembly; and the mounting assembly coupled with the driving assembly, wherein the mounting assembly comprises a sensor configured to sense resistance and generate sensor data indicating the resistance.

2. The shunt insertion system of claim 1 , wherein the positioning assembly comprises: a platform; a handle; and a first mounting plate configured to be coupled to the driving assembly.

3. The shunt insertion system of claim 2, wherein the driving assembly comprises: a push-pull assembly configured to be coupled to the mounting assembly and control movement of the mounting assembly; an actuator configured to actuate the push-pull assembly; and a second mounting plate configured to be coupled to the first mounting plate of the positioning assembly.

4. The shunt insertion system of claim 3, wherein the actuator comprises at least one of an electric actuator, a hydraulic actuator, a piezoelectric actuator, or a mechanical actuator.

5. The shunt insertion system of claim 3, wherein the actuator is a stepper motor.

6. The shunt insertion system of claim 3, further comprising: a controller in communication with the sensor, the controller being configured to control the actuator, the controller further being configured to receive the sensor data and generate controller data based at least on the sensor data; a processor in communication with the controller, the processor being configured to receive the controller data from the controller, and process the controller data, and generate processed data; anda computing system in communication with the processor, the computing system being configured to receive the processed data, and generate commands for controlling the actuator.

7. The shunt insertion system of claim 6, wherein the controller is further configured to receive the commands from the computing system, and generate instructions for controlling the actuator based at least on the commands, and transmit the instructions to the actuator.

8. The shunt insertion system of claim 1 , wherein the mounting assembly comprises: a catheter support configured to support the catheter; and a mounting arm configured to be mounted to the driving assembly.

9. The shunt insertion system of claim 1 , wherein the mounting assembly is further configured to support a catheter of a shunt to be inserted into tissues.

10. The shunt insertion system of claim 9, wherein the catheter is configured to allow fluid flow therethrough.

11. The shunt insertion system of claim 10, wherein the fluid comprises cerebrospinal fluid (CSF).

12. The shunt insertion system of claim 10, wherein the resistance is a force exerted on the catheter by the tissues.

13. The shunt insertion system of claim 1 , wherein the sensor comprises a force gauge.

14. The shunt insertion system of claim 1 further comprising a safety feature configured to stop a movement of the shunt insertion system.

15. A method for controlling a shunt insertion system, the method comprising: collecting sensor data by a sensor; transmitting, by the sensor, the sensor data to a controller; processing, by the controller, the sensor data to generate controller data based at least in part on the sensor data; transmitting, by the controller, the controller data to a processor;processing, by the processor, the controller data to generate processed data based at least in part on the controller data; transmitting, by the processor, the processed data to a computing system; processing, by the computing system, the processed data to generate commands based at least in part on the processed data; transmitting, by the computing system, the commands to the controller; processing, by the controller the commands to generate instructions based at least in part on the commands; and transmitting the instructions to an actuator.

16. The method of claim 15, wherein the actuator comprises at least one of an electric actuator, a hydraulic actuator, a piezoelectric actuator, or a mechanical actuator.

17. The method of claim 15, wherein the actuator is a stepper motor.

18. The method of claim 17, wherein the instructions comprise an instruction on moving rate of the stepper motor.

19. The method of claim 15, wherein the sensor is a force gauge.

20. The method of claim 19, wherein the sensor data comprises information indicating resistance experienced by a catheter during insertion.21 . A non-transitory computer-readable medium storing instructions that, when executed, cause one or more processors to perform operations comprising: collecting sensor data by a sensor; transmitting, by the sensor, the sensor data to a controller; processing, by the controller, the sensor data to generate controller data based at least in part on the sensor data; transmitting, by the controller, the controller data to a processor; processing, by the processor, the controller data to generate processed data based at least in part on the controller data; transmitting, by the processor, the processed data to a computing system;processing, by the computing system, the processed data to generate commands based at least in part on the processed data; transmitting, by the computing system, the commands to the controller; processing, by the controller the commands to generate instructions based at least in part on the commands; and transmitting the instructions to an actuator.

Images