KR20200000898A - Insertion of medical devices and injection of drugs through nonorthogonal and orthogonal trajectories in bone tissue - Google Patents

Abstract

The present invention includes a device extended and modified for the insertion containing self-insertion through a human body, particularly the skull. The device has at least one operating device or a sensor, and designates directions of components at different angles so as to insert a plurality of functional components to the skull through a single introduction portion. The device is used to provide electric, magnetic and other stimulation therapy for the brain of a patient. The lengths of the operating device, the sensor and other components can completely cross the thickness of the skull (at the diagonal angle), and can penetrate the brain cortex to protrude slightly. The components can come into direct contact with the brain cortex and thus, signals of the components can be sent to deeper targets inside the brain. The length of the operating device is directly proportional to a battery size and capabilities to store charges of the operating device. Accordingly, a long electrode operating device which is not limited to the thickness of the skull enables a long lasting battery to increase treatment options.

Description

 Medical device insertion and drug injection method through non-orthogonal and orthogonal trajectory in bone tissue {INSERTION OF MEDICAL DEVICES AND INJECTION OF DRUGS THROUGH NONORTHOGONAL AND ORTHOGONAL TRAJECTORIES IN BONE TISSUE}

The present invention relates to medical devices, systems and methods for accessing structures in bone tissue. Specifically, the present invention relates to altering the function of bone tissue and modifying physiological phenomena in bone tissue. More specifically, the present invention relates to surgically implanting electrodes or other devices in bone tissue to alter or improve the environment in the bone tissue. Most specifically, the present invention is directed to minimizing surgical methods and risks and maximizing the ability to retain the length and charge of a device that can be implanted into or through bone tissue.

Electrical or ultrasound stimulation can change the physiological state in bone tissue or improve and alleviate pathological conditions. Stimulation involves placing an elongated electrode through a burrhole in the bone surface to a target deep in the bone tissue. The electrodes are arranged with stereostereo guides with or without a frame. Frame-based systems, such as the Leksell frame, require a rigid stereoscopic frame to be secured to the skull through several screws fixed to the two. The frameless system uses fiducial markers placed on the skin. In both methods, MRI (magnetic resonance imaging) or CT (computed tomography) scans are performed using in-place frames or origin markers. In frame-based stereotaxy, the target area is reconstructed under computer assistance to localize the target in relation to the coordinates of the frame. In frameless stereotactic, the three-dimensional reconstruction of bone tissue coincides with the three-dimensional configuration of the fiducial marker. In both cases the end result is the ability to virtually accurately place the electrodes in any part of the bone tissue.

As the electrodes reach specific sites through various structures in the bone tissue, there is a risk of damaging blood vessels as well as intermediate healthy tissue. Such unnecessary and unavoidable damage can potentially lead to loss of function and bleeding. On the other hand, the stimulation of the cortex is safer because the electrode is placed on the surface of the bone tissue, that is, outside the periosteum. In addition, subcortical or deep structures are mostly associated with targets of substrates in the cortex, and these targets are candidates for cortical stimulation. In addition, direct stimulation of the cortex may affect subcortical structures that communicate directly or indirectly with targets of the cortex.

Similarly, the cortex and some subcortical fibers can be activated by magnetic stimulation or direct current stimulation. In this approach, magnetic or electric currents are activated in the skin or mucous membranes and transmitted through bone tissue to activate parts of the cortex and subcortical fibers.

The prior art and the state of the art regarding the stimulation technique of the tissue in the bone tissue need to place the electrode through a drill to drill a small hole in the bone tissue. This process is at risk of tissue damage due to the invasion of the technology. In addition, this "open" technique is particularly difficult to fix the electrode because in most techniques the lead must pass through the hole in the bone tissue. If the electrode is not fixed by the suture chamber or device, it is likely to move or move.

Current cortical bone stimulation techniques also risk cortical scars as well as bleeding. Long-term placement of foreign objects inside bone tissue causes scarring (inflammation). This can be seen both in the spinal cord stimulator placed in the spinal cord and in the prosthesis placed in the bone tissue. These scars can lead to various complications. Sudden relative movement of electrodes attached within bone tissue can cause blood vessels in the bone tissue to break, resulting in subdural, subarachnoid and cortical hematomas. However, if the electrode is embedded in bone tissue, there is no risk of this kind of cut damage during traumatic injury, such as due to a sudden crash accident.

Invasiveness of electrode placement techniques should be minimized to extend intraosseous stimulation to a larger patient population. As many surgical experts have demonstrated, the minimal surgical approach is shifting to safer surgery, with mainly shorter hospitalization days and higher patient satisfaction.

Advances in miniaturization in the field of microelectronics have enabled the development of fully embedded miniature electrode systems called bions, which are small enough to be injected into muscles and other bodies via syringes. This type of microelectrode device contains magnetic pole and recording electrodes, amplifiers, communicators and power components all integrated into a hermetically sealed capsule. Some bio-devices have a battery integrated in the unit, while others are operated by radio frequency transmission. The bion electrodes can be implanted in muscles and other body parts, but it is difficult to implant the bions between structures having a thickness of about 1 cm or less. This limited thickness limits the size of the battery as well as the size of the electronic components. Battery capacity (the amount of energy stored in the battery) determines the length of time of the charging interval in a rechargeable battery and is affected by the length of the battery. For vione, an injectable device that requires a small diameter, battery capacity is directly related to the length of the battery. The longer the bion electrode, the longer the battery, and therefore the greater the battery capacity, and the longer it can operate without recharging.

Some patents cover implantable stimulation devices and electrical stimulation therapy systems. However, these patents are not specially adapted to introduce multiple components through a skull by introducing some components at non-orthogonal angles.

For example, assigned to U.S. Patent No. 5,324,316, entitled "Implantable micro stimulator", inventor: Joseph H. Schulman, et al., Alfred E. Mann Foundation For Scientific Research (Sylmar, Calif.) ) Discloses an implantable stimulator containing an electrode in a hermetically sealed housing that is inert to body fluids. The electrode receives energy from a capacitor that stores energy, including the coil transformer, and the coil converter receives energy from an alternating magnetic field. This patent discloses that "miniature stimulators can of course be implanted in muscles, nerves, organs or other body regions, in or near any part of the body, in the brain" (4: 24-26). However, how the microminiature stimulation device is or can be implanted in various sites is not described in detail. It is presumed that this is done according to conventional methods, such as introducing an existing long electrode through perforation. There is no mention of inserting through the skull or cranial bone. This patent emphasizes that the stimulator is implanted by "ejection through a hypodermic needle" (Summary, 1: 13-15, 2: 7-10, 2: 35-37, etc.). Clearly hypodermic needles cannot be injected through the skull, suggesting that these stimulators are not designed for this purpose. There is also no description of a number of interconnected parts that have passed through a single entry site by inserting some parts at non-orthogonal or diagonal angles. Hermetically sealed housings that are inert to body fluids prevent microminiature stimulation devices from wire communicating with each other and sharing power via wire connections with other units. As such, in the system of USP '316, each microminiature stimulator is essentially a physically separate entity and interacts with an external magnetic field and is charged by the magnetic field, but not with other microminiature stimulators without wireless communication. It doesn't work.

USP 6,208,894, titled “System of Implantable Devices for Monitoring and / or Influencing Body Variables” (also invented by Joseph H. Schulman, et al., Described by Alfred E. Mann Foundation For Scientific Research) (Sylmar, CA) and Advanced Bionics, Inc.) are designed to be "grafted into the patient's body, ie within the area defined by the patient's skin," rather than through the skin and / or skull. Initiate a system control unit (SCU). In the present invention, bone tissue, not skin, defines the zone. The SCU communicates wirelessly with various self-addressable devices, and in some cases, self-addressable devices also wirelessly communicate with one another ((7:50). USP '894 does not refer to bone tissue USP' 894 does not originate from the patient's brain, or communicate directly (in the absence of an intermediary SCU) and through direct contact (which may be more reliable than wireless). It refers to sensing signals generated by the brain (2: 44-48, 11: 3-6), but does not disclose that any device is actually inserted into the brain or on the surface of the brain (epidural). The device is implanted past the site of injury and appears to replace the damaged nerve (2: 40-52).

Advanced Bionics, Inc. owns several patents for its "miniature stimulation system". See, for example, USP 6,181,965, USP 6,175,764 and USP 6,051,017. These patents also disclose implantable microminiature stimulator systems having a hermetically sealed housing configured to be implanted through a hollow cannula. The electrode protrudes from the housing. In addition, the housing has a polymer coating that may contain a chemical agent or agent to provide drug therapy simultaneously with electrical stimulation. There is no mention of bone tissue, only the brain is mentioned in the background with regard to loss of veterinary muscle function due to communication of brain signals and damage to the brain.

Advanced Bionics, Inc. also owns various "methods" patents that specifically address brain stimulation through intra-brain implantation of system control units and electrodes (see, eg, USP 7, 151,961, USP 7,013,177 and USP 7,003,352). These patents highlight method claims. The implantable microstimulator SCU / electrode systems disclosed therein are similar and the methods apply to many uses of such systems. In these methods the control unit must be implanted “in the brain” (in comparison to the surface or exterior of the body) (claim 1 of USP '961) and from the pump and infusion outlet as an alternative to or in connection with electrical stimulation. Emphasize drug delivery. These patents refer to "skull bone" in the sentence "grafting ... into at least one of the skull and brain" (see claim 1 of USP '177). There is no description of multiple parts or non-orthogonal / diagonal / radial insertion angles passing through a single entry site.

Vertis Neuroscience, Inc. owns two patents that discuss the insertion angle control and depth control of electrodes. However, neither patent teaches or suggests integrating electrodes in a screw housing or other component that can penetrate the skull or cranial (not just the skin) to access the cortex of the brain. It also does not teach applying angle and depth control to mount more than one electrode through a single entry site. 10-11 illustrate multiple entry sites with separate spots for each electrode.

USP 6,622,051 (invention name: "" Percutaneous electrical therapy system with electrode entry angle control ", inventor: Jon M. Bishay, et al.) Is a device for controlling the angle of entry of electrodes with sharp ends and electrodes entering through tissue. There is no mention of non-orthogonal or diagonal insertion angles for mounting additional electrodes or other components through the same entry site, using the entry angle control assembly to determine where the sharp tip of the electrode end ultimately ends. Control, thereby improving local electrical stimulation therapy The electrodes are dispensed by an introducer with a spring similar to the eviction through needle and cannula disclosed in Alfred Mann and Advanced Bionics patents. It can be distributed by the same introduction device and arranged radially about the hub (10: 17-27), but the same entry section There is no explanation for inserting a plurality of electrodes through the above The introduction device can be moved to insert various electrodes in different chambers at different positions.

USP 6,549,810 (named “Percutaneous electrical therapy system with electrode depth control”, inventor: Paul Leonard, et al.) Is similar to USP '051, but in addition to an angle control assembly, a depth control assembly is also used to provide electrodes in tissue. Specifies the position of the sharp end of. The depth control assembly includes a mover and a limit stop. In the present invention, the length of the electrode can be used to determine its optimal insertion angle, so that the electrode length is equivalent to the length of the cranial passage. This allows the electrode to exit the skull and immediately terminate in the cortex of the brain, balancing maximum efficacy and minimal invasiveness. As such, the electrode length is fixed and considered in determining the angle, so that when the electrode is inserted (moving device is not essential when doing this), it can be inserted completely without the need for a limit break.

In both Vertis patents, the electrodes are in electrical communication with the transmission control unit. There is no explanation that the electrode itself is used for transmission.

In the present invention, the electrode cooperates in communication with other electrodes and supporting components (ie, receiver, transmitter, battery, recharger, etc.) to form an integrated treatment system in which multiple components are inserted through the same site.

The present invention provides an improved method for inserting actuators, sensors, actuators and systems of sensors, and other implantable medical devices through the skin, bones, muscles, tissue, and other media between the body's outer surface and the intended physical contact. Includes a way. Physical contacts in the body may be targets where information is gathered by sensors and energy is sent by actuators. Alternatively, the physical contact may be a transceiver station from which information is received from another target (deeper interior) by a sensor, or energy from there is sent to another target (deeper interior) by an actuator. When implanted into bone tissue, the device of the present invention described herein is referred to as Bioscrew ™.

The actuator may include any component that causes or induces an effect on a target in the body, or acts as a stimulus. Preferred examples of actuators are electrodes which cause effects through electricity. Other types of actuators use magnetic force, temperature, infrared light, light, vibrations, ultra-ultrasound energy (a frequency beyond human hearing), ultrasonic energy, radio waves, microwaves, etc., to produce effects. It includes a transmitter.

Sensors can receive and record data about temperature, light, density, impedance, etc. in the form of radio waves, microwaves, and spectroscopy.

According to a preferred embodiment, the present invention focuses on improved devices and implantation methods implanted into bone tissue to provide therapeutic treatment of brain conditions and medical conditions with neurological components.

The improved method involves modifying the implantable device to a specific size and shape so that one or several devices can be inserted simultaneously through two single entry sites by changing the insertion angle of each unit. Individual units are inserted in an orthogonal and / or non-orthogonal manner with respect to two surfaces tangential to a single common entry site. Individual units can be physically connected through a connector head at a common entry point, thereby sharing electronics, power and other properties. In addition, in some embodiments, the distal end of the shaft and the shaft of the device may be configured so that the device is inserted directly. Direct insertion means that no or almost any other tools or instruments are needed to make the entry site and / or the hole into which the implanted device is to be inserted. For example, the device can be encapsulated in a helical outer threaded screw housing, and because the shaft has a sharp distal end, the entire device can be drilled through the skin and screwed to the bone, similar to the self-drilling screws currently in use. Can be. The self-insertion feature allows the electrode to be inserted almost anywhere very quickly during minimally invasive screw-in or pop-in process.

The types of medical devices that can be modified and implanted by the methods described herein are virtually unlimited, including neural stimulation systems, neural recording systems, brain-machine interface systems, cryotherapy systems, thermotherapy systems, magnetic field generation systems, Radiation emission systems, auditory systems, iontophoresis systems, interpersonal communication systems, inter-biological communication systems, and the like. Currently, electrodes placed on or near the surface of the brain are used clinically to treat many diseases including seizures, pain syndromes, motor disorders, psychosis, paralysis, and neurodegenerative disorders such as ALS. One preferred embodiment of the present invention is to implant one or more cortical stimulation and recording electrodes close to the surface of the cortex through a single minimally invasive cranial entry site, while at the same time they are adapted to be inserted at a gentle angle, not limited to vertical insertion only. The size (especially the length) of each unit can be made larger than the thickness of the skull to increase battery life and complexity of each electrode unit. However, according to the present invention, some electrodes (or other actuators) may be equal to or shorter than the thickness of the bone tissue. In multi-part devices and systems of devices with short electrodes (or other parts) adapted to insert shafts at various angles, more parts may pass through a single entry site than previously possible. The electrode may take the form of an implantable microstimulator or an improved bioion, and is embedded in bone tissue with its distal end positioned epidural (above the epidural) or subdural (subdural) near the surface of the bone tissue.

The thickness of the cortical bone is limited to the length of 0.5mm to 1.75mm. If the electrode is inserted straight down perpendicularly (orthogonally) to the surface of the cortical bone, the length will be limited to at least about 1.5 mm. An electrode longer than 0.5 mm implanted into the cranial bone in an orthogonal manner will protrude into the bone tissue through the cortical bone. Placing electrodes in bone tissue risks damage to the brain and blood vessels during placement and subsequent physiological pulsation of the brain in relation to bone tissue and during head trauma that causes the brain to accelerate and decelerate in relation to the skull. This increases. Current cortical stimulation methods place electrodes under epidural (outer epidural) or subdural (between the epidural and astral or extraarachnoid). Placing electrodes in these places provides low impedance stimulation to bone tissue while maximizing safety. Current cortical electrode placement methods require perforation or opening by drill, all of which are dangerous to the patient and typically need to be admitted to an intensive care unit to monitor postoperative progress.

The present invention describes a method of inserting a device and an electrode unit via orthogonal and non-orthogonal trajectories through the two. The angled insertion of the electrode units allows the use of longer units (lengths longer than the skull thickness) without penetrating the brain. Angled electrodes pass through the skull almost entirely and then project slightly to the cerebral cortex. Longer electrode units are preferred because the length of the battery is proportional to the size and capacity of the battery. As such, longer electrode units may contain longer and larger batteries. Preferably, the battery can be recharged. However, regardless of whether the battery can be recharged, the stimulation electrode preferably has a maximum battery capacity (time to replacement or recharge). High capacity batteries provide continuous therapies and enhance patient mobility and freedom. The greater maneuverability and freedom provided by high-capacity batteries in elongated electrodes increases the likelihood that patients will be admitted to the outpatient process because they can easily follow the prescribed treatment regimen during their normal lives.

The longer electrode unit also allows more components to be integrated into each implant. The larger size allows flexibility in terms of both the complexity of the network, communication components, as well as the ability to record (receive) and stimulate (transmit). In addition, multiple electrode contacts may be more easily placed in a single implant, ie a bipolar, tripolar, quadrupole stimulus or recording may be in each electrode unit.

The ability to insert several electrode units through entry sites in a single bone tissue is very beneficial. It is obvious that bone tissue provides an important protective function for the maintenance of body structure. Therefore, it is desirable to keep the cortical bone as undamaged as possible while approaching bone tissue for treatment. Fewer entry points within the bone tissue preserve the integrity of the bone tissue and reduce the likelihood of bone tissue being inadvertently exposed or damaged. However, if there are fewer electrodes at the entry site, this may have disadvantages with regard to the variety and intensity of the therapies that can be provided. The ability to insert several electrodes through a single site provides powerful therapies without jeopardizing the two, more importantly the bone structures and blood vessels. Even if no stronger therapy is needed, multiple electrodes in the same area may still have advantages because they can be selectively activated individually to extend the time to recharge. For example, if the electrodes are radially placed outward from the common insertion point, when the battery of the first electrode is exhausted, the system may proceed to turn on the next electrode either automatically or manually so that it may be stimulated. In addition, a plurality of electrodes arranged in a spatially distributed pattern in a two-dimensional or three-dimensional space can manipulate the stimulation current in the space. Current manipulation was used for spinal cord stimulation and was performed by differential activation of spatially separated electrodes. In addition, different electrodes or other components (ie, sensors) inserted through a common entry site may be used to provide different therapeutic benefits (electrical stimulation, magnetic stimulation, drug delivery, etc.), or different types of data (blood glucose). Level, temperature, pH, etc.) can be collected.

The stimulation module is designed as a single implant within a single trajectory or as a multiple implant with multiple trajectories. Depending on the specific needs of the individual, the stimulation module may contain one, a combination, or all of the following components: stimulation electrode (s), recording electrode (s), pulsation generator, system control unit, battery, capacitor Current sinks, data signal transmitters, data signal receivers, receiver coils, transceivers, transducers, sensors, program storage, memory units, internal electronics, analysis circuitry or software. All of these parts can be contained in a single implant similar to bione. However, these parts can also be divided into individual units that are implanted in separate trajectories. Since the units pass through a single entry site they can be wired at this point. Optionally, they may be in wireless communication with each other. For example, if an individual wants or needs an implant with a long battery life, multiple units of batteries may be implanted together to form a wiring. Since the battery unit does not need to contain electrodes or pass through the inner layer of the skull, the battery unit can be implanted in the trajectory of the maximum length allowed by the curvature of the two sponges without passing through the two inner or outer cortical layers. . Flexible units that bend under two curvatures allow even longer implants. Such curved linear electrodes can slide into the sponges between the cortical layers. The curved stimulator and electrode need not be rigid or rigid, but may be semi-flexible to allow for easier sliding and manipulation into the spongy space. In fact, only the actual electrode contacts need to pass through the cortical bone into the epidural or subdural space. All other parts can be implanted into the cortical bone without leaving the cortical bone. The system is customized with specific modules or components for each individual, target within each bone tissue and for each specific purpose or disease to be treated.

Implantable stimulation electrodes and related components provided herein have a rich use. They can be used in damaged bone tissue to stimulate regeneration and repair, and to record changes so that biological signals (including non-animal persons) can simply communicate with the outside world. Another use is the use of implantable bone tissue electrodes as a means of communication between people or other living organisms, where by training a person (or other living creatures, including other animals and potentially plants) can Learn to recognize specific patterns of neural signals. In this way, it may be possible for humans and other living creatures to have invisible and inaudible conversations using only their bio signals. This technology has important commercial and military uses. In addition, the implantable unit does not need to approach the brain for communication, and instead the vibration generated by the implant can communicate directly by stimulating the inner ear wherever it is located. For example, a stimulator (with multiple parts positioned at different angles through a single area) can be used in the inner ear as a transmitter and receiver that can interact with a mobile phone (such as by Bluetooth technology) for hands-free conversation. Can be. Related ear devices have been successful in transmitting auditory signals to the opposite ear when used in partially deaf persons (or other animals), such as in the ear or in one ear deafness.

Electrode stimulation and recording has a wide range of uses that reflect those currently in clinical use, and other preferred embodiments are also abundant. Another preferred embodiment is an implant utilizing temperature differences to activate or inactivate skeletal tissue. In this embodiment, the heat conducting element is implanted through the cranial into the subdural or epidural space. Parts implanted via other trajectories include those described in the electrode embodiments described above, and also include heat pumps, thermopower generators, and thermostats. Cooling of the brain typically inactivates nerve activity and can be used for seizures, migraine headaches, pain and other disorders.

The electronic network of the present invention may be well suited to various configurations or embodiments. The present invention encompasses all conventional electronic network configurations, such as electrodes, stimulators, bions, etc., adapted to insert multiple parts across two at orthogonal and / or non-orthogonal angles.

Other objects and advantages of the invention will be set forth in the description which follows. The inherent variations of the invention based on the clear description can also be at least partially apparent from the above description, or can be learned by practicing the invention. Such subtle and predictable variations and modifications are within the scope of the present invention. Further advantages of the invention can also be obtained and realized by means and combinations particularly pointed out hereinafter.

The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention and, together with the general description given above and the description of the embodiments given below, serve to explain the principles of the invention. All.
1 shows how the trajectory of each device or shaft at a particular entry point is defined by the axial angle θ1 (FIG. A) and the radial angle θ1 (FIG. B). The skull is represented by hemispheres, in two cross-sections in (A) and in one cross-section in (B).
1A shows two non-orthogonal trajectories, both of which have the same axial angle θ1 with respect to the vertical axis at the entry site. The radial angle θ2 is the plane angle that is tangent to the skin or skull at the entry site. In the conventional anatomical anterior orientation, ie the direction facing the front of the face, or the forward oriented part projecting above the tangential plane at the entry site is set to zero degrees.
2 shows a number of devices inserted from different entry sites, which are angled to converge on the same target in the brain from different directions.
3 shows a number of devices inserted from a single entry site at different angles diverging from the entry site targeting different targets in the brain.
4 shows a straight line (ratio) with the device insertion axis angle θ1 that completely crosses the skull thickness t based on the lateral displacement variable x when the device is fully inserted, ie sin θ = x / l. Curved device) Demonstrates the geometric relationship between device length (l).
FIG. 5 illustrates the relationship between the thickness or diameter of the device and the maximum length of the device when the device is implanted with increasing axial angle θ1, ie with increasing non-orthogonal insertion angle.
FIG. 5A shows that a small diameter device can have a longer length at a large insertion axis angle θ 1. However, when the diameter of the device is similar to the thickness of the skull, as shown in (B), the length of the device cannot change with any insertion axis angle θ1.
5B also shows that as the axial angle increases, the ends of the larger diameter device can no longer penetrate the inner cortical layer of the skull. Instead, the sides of the device penetrate the inner cortex. On the other hand, (A) demonstrates that at larger axial angles θ1 the ends of the thin device can still penetrate the inner cortex. As such, non-orthogonal insertion of the device generally requires that the width or diameter of the device be less than the thickness of the skull.
6 illustrates an apparatus consisting of four multiple shafts and components arranged in a straight array on the cortex.
FIG. 6A shows a wide top view, (B) shows a side view, and (C) shows a view from inside the cranium. All four shafts are inserted using one small punch. One perforation has a partial thickness because the lower edge of the partial perforation is used to guide the end of its own drilled shaft or drill bit. Two long shafts are located on the side of two short shafts, forming a straight array as shown in (C) where the four ends of the shaft appear to protrude through the inner cortex. The linear stimulus array shown in FIG. 6 is useful for stimulating along a straight brain, as in the case of motor cortical stimulation, in which case typically a small cranial is used to position the strip electrode.
7 illustrates an apparatus consisting of nine different shafts disposed through one partially small perforation. The overall configuration is shown in the cross section of the skull model in three different figures (A), (B) and (C). Top and bottom views (D) and (E) show the arrangement of contacts that penetrate through the internal cortex and affect the brain. Four short shafts are configured in a "+" configuration, and four long shafts are inserted in an "X" pattern. The shortest shaft in the middle is inserted last. This configuration allows the parts to reach the cortex in a 3x3 matrix. This type of configuration is useful for epileptic stimulation, in which the central electrode senses seizure activity at the seizure focal point. This center electrode then activates its stimulation electrode to stop the seizure. At the same time, eight electrodes arranged in a ring form around them are also activated. Activation of the electrode ring helps to trap and eliminate seizure activating waves that spread from the central interstitial focal point. This configuration generally requires craniotomy, but in this configuration it is placed through one partial perforation.
8 illustrates a shaft inserted at an axial angle that acts as a conduit for a guided and steerable epidural or subdural electrode array.
8A illustrates the drilling of two penetrating non-orthogonal holes by a self-drilling shaft. In (B), the inner compartment of the shaft is released and removed from the outer threaded portion leaving a cylindrical conduit. This conduit allows one or more electrode arrays to be inserted into the epidural or subdural space (C). The angular non-orthogonal trajectory of the shaft allows the electrode array to slide safely into the epidural or subdural space at a gentle angle. On the other hand, if the perforations were orthogonally oriented, the electrode array would have to pass through the skull and then rotate 90 degrees. The electrode array can be oriented similarly to the spinal cord stimulating electrode array by using mechanical rotation to slightly distal the distal end of the inner probe. Alternatively, the inner cannula of the distal end may be ferromagnetic, such that an external or electromagnetic field may guide or direct the ends of the electrode array. Finally, a fibrous inner cannula with a camera at the distal end can be used to guide the electrode array in an endoscopic manner while directly viewing the epidural, subdural, or intraventricular structure. In addition, the tip of the probe emits signals such as radio frequency or sonic / ultrasound impulse, enabling stereoscopic image guidance, which helps to limit the distal tip to stereoscopic coordinates. Once the target and desired placement of the electrode array has been achieved, the proximal end is secured to the two conduits / shafts by a fixing mechanism. Alternatively, other components, such as batteries, controllers, transducers, etc., may also be placed in the cannula or in different trajectories through the two from the same entry site. The combination of multiple shaft arrangements and multiple steerable electrode arrays through a single entry site allows for an infinite configuration of brain stimulation and recording through one small perforation.
9 shows a simple connection system for physically connecting a plurality of shafts and parts arranged through a single entry site or adjacent entry sites. The connector shown is a multichannel connector, but any connector, including a USB or micro USB connector, will suffice. The parts can communicate wirelessly with each other with the appropriate parts contained within the shaft, but some functions are more effective through direct physical connections.
10 shows a preconfigured head unit used to assist in the placement of multiple shafts and multipart arrays.
10A shows an empty head unit with three docking stations.
10B shows one shaft inserted in one docking station. In (B), two shafts were inserted into the head unit, and in (C) all three shafts were inserted. The head unit allows for direct communication and connection between all shafts and shaft parts. The head unit itself may also contain several components of the overall device, such as batteries, communication systems, transducers and the like. The head unit can be inserted into a pre-made punch or it can be inserted by itself by means of its own drill and its tapered tip. The head unit does not need to be fixed to the skull itself since the insertion of the shaft through the docking station acts to secure the docking station to the skull. Each docking station can also steer the insertion angle by having a rotating ball / socket mechanism as the docking station into which the shaft is inserted.
11 is a flow chart of a method for implanting a device described herein: (I) identify a target, (II) make an incision, (III) drill a partial thickness perforation with a drill, (IV) target from a partial thickness perforation And check the depth, (V) insert the device (s), (VI) suture the wound.

The present invention and its method of use can provide improved and / or long lasting therapeutic benefits by allowing multiple actuators, sensors, and other components to be mounted through a single entry site. According to some embodiments, this is achieved by inserting the actuator, sensor, other part, or shaft, which receives any of these elements, at different angles, so that a smaller surface entry area can reach the deeper surface. As used herein, the term “entrance site” includes one or more physically separated openings, holes, or incisions, which are located very close to each other and occupy a relatively small total space area to conform to minimally invasive surgical procedures. As such, the “entry site” may be one opening or hole, but is not limited to such. In addition, an "entry site" can be an entry zone, area, or area that includes two, three, four, or more separate openings.

At each entry site, the stimulator / sensor device can be inserted at several different axial angles between an axis perpendicular to the surface of the skin at the entry site (straight down) and a plane tangential to the surface of the skin. The actuator (ie electrode) and / or sensor may also be inserted at several different radial angles about the outer periphery of the entry site in a plane tangential to the entry site. The position of the entry site, the axis (θ1) and the radial (θ2) insertion angles determine the intrinsic trajectories inside and inside the skull. Preferably, the two stimulator / sensor devices (including at least one actuator or sensor as part of the device) do not have the same axis (θ1) angle, radial angle (θ2) and entry site position, so that Each device (and each actuator or sensor therein) occupies a unique location that is different from each other. The closer the first diagonal axis angle is parallel to the skin surface, the longer the actuator or sensor can be and can traverse substantially outward through the skull without reaching the brain. On the other hand, the closer the first diagonal axis angle is to the perpendicular to the skin surface (down straight), the shorter the actuator or sensor moves as the actuator or sensor moves vertically through the skull and thus the vertical of the skull. More severely limited in thickness (see FIG. 1).

Angular implantation allows the implantation of external components to support or cooperate with an actuator or sensor (ie, electrode) to form a long lasting system or improved bioion. For example, the main device can be implanted vertically, and one or more components (ie extended battery or battery pack) are implanted at an angle. This allows the external parts supporting the main electrode to be embedded in the skull at an angle. More support batteries extend the life of the electrodes, while at the same time effectively splitting the entire implant into several parts that are connected by the connector head or connector (i.e. from the top). In addition to batteries, other components include transmitters, receivers, wireless transceivers, heat generators, cooling devices, magnetic coils, capacitors, ultrasonic transducers, ultrasonic emitters / receivers, electrophysiological recording means, sensors, iontophoresis means, optical Stimulation device, laser, camera, address / placement unit, or the like.

The term "part" as used herein includes, but is not limited to, an actuator and a sensor. In addition, “parts” may include other categories of supplemental, supplemental, or supplemental elements that support an actuator or sensor but do not act on the body or directly sense (collect data) themselves. For example, a "part" can include buffer solutions, physical cushions, catalysts, batteries, vacuum lines, and the like. The present invention includes an implant in which at least one component is an actuator or a sensor. In addition, the implant may include other additional components, which are also actuators or sensors, or neither actuators nor sensors.

Implantable devices described herein are made of biocompatible materials. In self-insertion embodiments, the device should be made of a sufficiently durable and rigid material that can penetrate the bone without fracture. In embodiments where the drill is predrilled, more material choices are possible and the device can be encapsulated or accommodated using softer, more flexible materials. According to a preferred embodiment, at least part of the device is made of a semi-permeable material which absorbs some molecules, delivers some molecules (perfusion), elutes some molecules, and blocks some molecules. Such semi-permeable material may be a mesh with openings (eg, very small nanopores), which optionally also includes key cells or molecules embedded within the material surface (providing auxiliary functions).

According to a preferred embodiment, the actuator is an electrode and the supporting part of the invention (ie transmitter, receiver, etc.) is designed for direct insertion or for self insertion. "Self-inserting" or "directly inserted" means that the part does not require a perforation made by the drill in two prior to implantation and / or that the part does not need to be ejected through the introduction device (ie needle, cannula, etc.). It means. Self-inserting screws of this kind are typically categorized as self-drilling and self-decreasing in that they do not require pilot holes and the holes do not need to be tapered to form a threaded track of the screw. This can be achieved by a part with a housing that resembles a screw shaft with a sharp distal end and a thread.

Alternatively, the cranial stimulator device may be spiral shaped, which is wound around the bone in a manner similar to the coil anchor of a sand volleyball net. The distal end of the spiral enters the small hole, followed by the curved tail of the device.

When it is necessary to drill into the skull, for example due to an increase in bone resistance such that the self-taking screw is unsuitable, preferred systems and methods include the use of balloons along one or more sides of the stimulator. . Drilling usually produces a slightly larger hole than necessary, or an incompletely shaped hole in which the screw is not tightly mounted. The balloon may be filled with air and / or fluid after being inserted in a retracted state, thereby closing the gap to reduce incomplete engagement between the drill hole and the stimulator, and providing improved frictional mounting so that the stimulator can be Make it less sensitive to movement. In addition, the balloon can be used on the stomach in close proximity to the stimulation device, thereby pushing the electrode contacts of the opposing distal end to make closer contact with the surface of the cortex.

If the actuator contains, is coated with, or is bonded to magnetic means (ie, coils, magnetic materials, etc.), they can be used to provide magnetic stimulation therapy in addition to electrical stimulation therapy. Magnetic energy can also be used to recharge the electric battery. For example, by inserting a magnetic coil inside the skull, it requires a magnetic field large enough to pass through the cranial bone (which in turn reduces the signal strength), rather than the one used in non-limited transcranial magnetic stimulation. Local magnetic stimulation (“intracranial magnetic stimulation”) can be performed at much lower intensity. The lack of the ability to limit treatments, also known as poor selectivity, can lead to over-range applications, which can lead to unintended damage to the surrounding area, and at the target site, the intensity of treatment may be too weak. The ability to localize therapy overcomes both of these drawbacks in systemic use.

In addition to electrical and magnetic stimulation, implantable electrodes or components associated therewith can be used to generate heat or cold. Heat and cold have been found to affect brain activity, and therefore, they can be used to supplement, supplement, or replace electrical and / or magnetic stimulation.

In addition to electrical and magnetic stimulation, implantable electrodes or components associated therewith can be used to generate heat or cold. Heat and cold have been found to affect brain activity, and therefore, they can be used to supplement, supplement, or replace electrical and / or magnetic stimulation.

In different embodiments, the actuator battery may be recharged in vivo through or in vitro, or through a connection with an in vitro charging device. According to a preferred embodiment, the actuator battery is recharged in the body through means of natural gas generation including changes in heat, fluid dynamics and the like. The battery may include a thermoelectric generator or thermoelectric generator that generates power using local heat in situ. Alternatively, the battery may include a mechanical generator that generates and stores energy using the natural pulsation of the brain and changes in cerebrospinal fluid pressure for the two.

In addition to the built-in electrode battery, the implantable sensor-actuator device of the present invention can be powered by many alternative means. To reduce their size, power can be obtained from the outside through means that receive less energy than conventional electrode batteries. More specifically, they may rely on ultrasound, microwave or radiofrequency energy from energy sources located in or outside the body, which are connected and absorbed through the receiving platform. These alternative energy sources do not require built-in batteries, so the device can be smaller. As such, the device is manufactured on a micron scale (length, width, height), not milliliters, and further through bones and muscles in the body, small channels and crevices, or without damage, without sacrificing anatomical structural integrity at minimally invasive conditions. Can be inserted more precisely. Another advantage of in-vitro energy sources and some complex electronics is that they are easy to upgrade and modify externally. Another advantage of actuators located radially downwards and outwards at different angles from the entry site is that the angle (s) can be accurately converged to the deeper target by the rays from one or more actuators when the stimulus target region is deeper in the brain. Can be set. One or more entry sites can be made from several different entry sites so that several different devices converge to the target from different directions (see FIG. 2). Alternatively, when one or more target regions are deeply located in the brain, several different regions may be reached simultaneously by directing the actuators at different angles using actuators from a single entry site (see FIG. 3). If the actuators are limited to conventional straight down insertion without angles, all the actuators (even through a large number of entry points) will converge at the core or center of the brain, in this case targeted at the middle region of the brain between the core and the cortex. You will not be able to provide a cure.

In alternative embodiments, the actuators can have the additional feature that the length and distance are maximized within the skull when they gather together. For example, the actuator may be a curve having a radius of curvature that approximately matches the shape or radius of curvature of the skull. Since there are two layers, the hard inner cortical layer, the hard outer cortical layer, and the soft spongy interlayer, the long part can be pushed through the hard inner cortical layer and the sponge layer trapped in the outer cortical layer. In addition, the device may be inserted once and then branched (eg, telescopic) to form an intracranial path that provides additional battery power storage space. However, because the branches must traverse through two rather rigid bones, in these embodiments (2nd, 3rd, and multi-branches), there is a separate insertion tool that can drill a worm-shaped tunnel for the branched device. Perhaps you will need it.

If the actuator is an electrode, the network of the present invention may vary for all embodiments. Electronic circuitry refers to the arrangement of electrodes, batteries, connectors, coils, transmitters, receivers, transceivers, capacitors, controller / programming means, address means, pulsation control means, sensors, and the like, and the correlation between them. Any configuration of these elements that functions for multiple electrodes inserted transversely through a single entry site (at orthogonal and / or non-orthogonal angles) is consistent with the scope of the present invention.

 In some embodiments, the configuration of the electronic circuitry may be similar to that of the existing product and patent claims (ie, the bions of Advanced Bionics, Inc.). However, the entire apparatus is still different from the conventional apparatus and patent claims. It is different that the one or more elements inserted through the same and / or through the same entry site are adapted to be inserted at non-orthogonal angles, such as by a screw-in manner.

In other embodiments, the configuration of the electronic circuitry is clearly different from one or more features of conventional products and patent claims, so that the present invention may be better distinguished in addition to other discernible features.

As discussed above, the device of the present invention as a neurostimulation device can improve the pathology of the nervous system (motor disorders, psychiatric conditions) and improve normal functions (learning, memory), in particular through direct interaction with the brain. Has numerous established uses. Additional potential uses include outer nerve stimulation and interaction with other physiological systems, thereby facilitating and controlling the healing process. For example, the implantable stimulator described herein can be used at bone fracture or disc degeneration sites and can be used for biological or chemical means (bone cement, bone graft, bone filler, bone glue, hydroxyapatite, bone flour composition, or other As a substitute or supplement for bone substitutes). One particular use is to use a stimulator around the pedicle screw used for pedicle screw stabilization / fusion of adjacent vertebrae to stimulate regrowth of the bone on the screw to better position the implant.

According to a preferred embodiment, the devices described herein can be used to enable communication between two or more entities, at least one entity being a living creature. The remaining entities may be other living creatures of the same or different species as the first living creature, or include, but are not limited to, computers, laptops, cell phones, personal digital assistants (PDAs), keyboards, cameras, wheelchairs, bicycles, cars, etc. It can be a machine that includes. The communication may be one-way, two-way, or multi-channel switched between several different entities (group conversations, or different entities that all communicate with the central hub).

In this method of enabling communication between at least one living creature and at least one other entity, a device comprising an actuator and a sensor is implanted in the living creature. At least one additional part is implanted in the remaining entities to interact with the device. Sensors of the first independent (living creatures) collect data and generate pulsations that send this data to the rest of the entity. The rest of the entity receives the pulsations through their parts, reads it, and translates it. In this manner, the first independent (living creature) can relay information in a dog loop communication manner, or can "talk" to other entities. In an alternative embodiment, the device of the first independent body further comprises at least one feedback component, the communication being in a closed loop manner, wherein the feedback component of the first independent body from the first independent body by the second independent body. Verify receipt of pulsations.

When receiving signals using a receiver or transceiver, they may be used alone to receive the signals directly, or may be used with one or more intermediary devices that process and / or relay the signals before reception. The intermediary device can amplify or reformat the signal and remove the noise. In some embodiments, the intermediary device in some applications may be similar to Bluetooth earphones, cell phones, Wi-Fi routers, air cards, and the like. Likewise, when using an actuator to induce an effect on an entity (machine or organism), they may directly induce the effect, or they may employ one or more intermediary devices that modulate or process the raw information and energy they provide. It can be guided through.

It is contemplated that the devices described herein can be adapted for use with the sixth state of the art sensory and mind control devices. The minimally invasive implant of the present invention can be more convenient than a headgear, which can be used to read nerve conditions and targets to initiate behavior in the outside world without relying on hand gestures from living creatures or patients. have. As used herein (before and after), the term “patient” refers to any subject that is itself a subject or receives treatment that incorporates the present invention. The "patient" does not necessarily have to be a sick person or someone with a physical, emotional or mental disorder or abnormality. In fact, the "patient" need not be a human, or even a living creature. A "patient" may include a completely healthy, happy and successful creature or object that is the subject of treatment or is treated according to the present invention, thereby developing their ability to become more successful or to improve a particular function. can do.

Examples of conditions that can be treated using the device of the present invention include general psychiatric conditions, genetic or biologically based psychiatric conditions, depression, acute mania, bipolar disorder, hallucinations, obsessive compulsive disorder, obsessive compulsive disorder, schizophrenia, tonicity, Post-traumatic stress disorder, drug and alcohol addiction, Parkinson's disease, Alzheimer's disease, epilepsy, tension, tics, stuttering, tinnitus, stiffness, recovery of cognitive and motor function after stroke, pain syndrome, migraine, neuropathy, back pain, visceral Diseases, urinary incontinence, and the like.

Specific medical uses include the use of the two implants of the present invention as follows: (i) A paralyzed person can operate the computer by sending a signal and moving the mouse, cursor, or typing the keyboard telepathically. To improve your work ability; And (ii) communicating his needs, wishes, and thoughts with others and the world by a paralyzed person sending a signal so that the machine or computer speaks a sentence or message about itself.

Specific entertainment and social uses include using the two implants of the present invention as follows: (i) iPhone or Wii instead of or in addition to the use of hands using implanted Cranion ™ Controlling the game console; And (ii) the implanted Cranion is capable of communicating with one or more others, each of whom has its own implanted Cranion, which is used for meetings, churches, courts, sporting events, and card games. Private "telepathy" conversations are possible in groups of people, including while.

Implanted devices (particularly those in the brain) of the present invention can be used to control a projector, camera, laser, barcode reader, etc., worn on the body. The sixth sense and mind control device can find use in video games, electronic payments, stock trading, shopping, social and professional networking and storage of data about people, photography, photography, and the like. Implants can be used to read the facial expressions (face expressions, gestures) and emotional experiences (emotional reactions) of the living creature to which it is inserted, or of others with whom the patient comes in contact. The implant can then process and analyze this information and initiate cognitive behavior in response to it.

Electrical signals in the brain's cortex are random within the population for the same idea, even if it originates in the same area of the brain, due to the unique wrinkle patterns of each individual's brain, similar to fingerprints. Headgear uses a mathematical algorithm to interpret random signals and match them in a group. Or alternatively, the implant of the present invention may be used to (i) read a signal from a source in the brain where the signal crosses the uniform cortex without an algorithm, or (ii) apply the algorithm to data read from the cortex, Or (ii) provide an initial equalization process that compensates for differences in individual signals.

According to another embodiment, Cranion ™ has an elongated electrode lead that is sent epidurally through the skull at a certain angle as the spinal cord stimulator slides up into the epidural space in the spine. This end can then be manipulated using, for example, a magnet.

The general method illustrated in summary in the flow chart of FIG. 12 may include the following sequence in more detail:

1) identify target (s) using stereostereo localization with or without frames;

2) Determine the configuration. For example, determine whether it is a single electrode, multiple electrodes around a single target, or a single line (see FIGS. 7 and 8);

3) single punched incision 5-10 mm;

4) Drill a 2-4 mm partial thickness perforation (this creates a "edge" so that the drill can be angled at the corners and off-angle trajectories can be achieved);

5) use stereostereo localization to identify targets and depths away from central partial perforations;

6) plan the trajectory based on the target and drill a pilot hole or insert a Cranion ™ device using its own drill method, its own tapered Cranion ™;

6a) Drilling a pilot hole gives an accurate indication of the depth of the hole, but a cannular Cranion (see FIG. 9), whose sharp end can be removed, also allows an entrance to determine whether it has entered the epidural space. ;

7) Other Cranions (trade name) are arranged and wire-connected to them (see Fig. 9) or wirelessly connected to them. Or a head device;

8) add other parts such as spare batteries that do not need to be completely removed from the skull;

9) Suture the wound.

The invention is not limited to the embodiments described above. Various changes and modifications can of course be made without departing from the scope and spirit of the invention. Additional advantages and modifications also readily occur to those skilled in the art. Accordingly, the invention is not to be limited in terms of the specific details and representative embodiments described and shown herein. Accordingly, various modifications may be made without departing from the spirit or scope of the general inventive concept as defined by the appended claims and their equivalents. The conjunction "or" as used in the claims means inclusive "or" (and / or any independent element or combination of elements).

Claims (13)

A device configured to act on or collect data about a target site within a living body, comprising: one or more shafts configured to be inserted through the skin, muscle, tissue, bone, or skull at the entry site; And at least one component comprising an actuator or sensor associated with each of the one or more shafts, wherein the at least one component is respectively received within the one or more respective shafts, passes through each shaft, or each shaft. Connected to the associated shaft by one or more of those attached to the at least one shaft and the associated component of the shaft between an angle parallel to the tangent of the surface at the entry site and an angle perpendicular to the tangent of the surface at the entry site. And configured to be inserted at all angles, wherein each of the one or more shafts is configured to be inserted at the entry site at different trajectories of all other shafts, the length of each shaft and its associated parts being associated with the other shaft and related parts of that other shaft. Is independent of the skin, muscle, tissue, Or the apparatus is not limited to the thickness of the skull. The device of claim 1, wherein the component comprising the actuator or sensor comprises a battery, an electrode, a recharger, a transmitter, a receiver, a transceiver, a sensor, a recorder, a capacitor, a transformer, a system control unit, a programmer, an address / placement unit, a temperature. Sensor, Temperature Controller, Thermo Power Generator, Thermoelectric Generator, Mechanical Generator, Light / Light Generator, Ultraviolet Generator, Infrared Generator, Optical Stimulator, Laser, Radio Frequency Generator, Magnetic Field Generator, Mechanical Vibration Generator, Ultrasonic Generator, Electric Field Generator , A radiation generator, a fuel cell, a drug delivery unit, a gene therapy delivery unit, a reservoir of drugs and radioactive substances, and a reservoir of substances released into the body. The device of claim 1, wherein each shaft is configured to be inserted through the skin, tissue, or bone in the absence of pre-made holes, the shaft being self-drilling and / or self-degrading. The method of claim 1, wherein the target site is in the brain of the patient, and the effect of the actuator is extended to the brain of the patient by the actuator or sensor communicating with the target site, or a stimulus that activates the sensor is in the patient's brain. Device derived from The combined length of claim 1, wherein the bone is a skull and the combined length minus an overlapping portion of the parts of the shaft, including the shaft and the actuator and / or sensor, includes a device or actuator or sensor. As part of the components of the device: (i) in the skin, adipose tissue, connective tissue, ligaments, tendons, mucous membranes, or muscles, on the epidermis of the skull, (ii) in the bone or skull, (iii) epidural ( Above the dura mater, (iv) subdural (under dural), (v) extra-membrane (over dense), (vi) in brain tissue, or (vii) in the ventricles or the groin associated with the brain. 6. The component according to claim 5, wherein the components comprising the actuator and / or sensor are located on or consist of a rigid, semi-rigid or flexible housing which extends through the shaft, the housing being a metal, plastic, polymer , Mesh, fiber, or textile material, wherein the shaft and / or one or more components on or within the flexible housing leading through the shaft are guided to a target location by one or a combination of the following mechanisms: Phosphorus device: i) Mechanical of the housing, such as a curved internal probe, which may be steered by having a bendable end, or which may be steered by rotating, advancing or retracting the housing and the probe. control; ii) the magnetic of the housing, wherein the ferromagnetic or electromagnetic end of the housing or the end of the removable probe in the housing is guided, manipulated or moved by a magnetic field induced by a magnetic or electromagnetic mechanism in or out of the body; control; iii) Stereostereoscopic guidance to the target where stereotactic localization is based on one or a combination of the following techniques: magnetic resonance imaging (MRI), functional magnetic resonance imaging (fMRI) , Magnetic resonance spectroscopy (MRS), diffuse MRI (DWI), diffuse tension muscle MRI (DTI), electroencephalography (EEG), cerebral gyrus (MEG), nuclear neuroimaging, positron emission tomography (PET), single photon Emission Tomography (SPECT), Seizure-Seizure Interval SPECT Analysis (ISAS), Statistical Tomography, Computed Tomography, X-rays, Fluoroscopy, Angiography, Ultrasound, Transcranial Magnetic Stimulation (TMS), Transcranial Direct Current Stimulation (tDCS), Transcranial Electrical Stimulation (TES), Motor Induced Potential (MEP), Somatosensory Potential (SSEP), Phase Reversal of Somatosensory Induced Potential, Induced Potential, Cortical EEG (ECoG), Direct Cortical Electrophoresis Stimulation (DCES), microelectrode recording (MER) and local field potential recording (LFP); iv) Endoscope Visualization and Guidance. The apparatus of claim 1, further comprising a head unit attached or coupled to an end of the first shaft, wherein the head unit includes one or more docking stations, each docking station receiving at least one additional part or parts thereof. And the docking station has one or more holes or connections therein through which one or more component (s) or shaft (s) receiving these components are inserted through the head unit, or Attached to the unit, connected to the head unit, or connected to the head unit, the docking station is radially spaced around the head unit such that several parts or shafts containing these parts have different angles around the head unit. Vertically downward, radially outward, or radially inward And the apparatus that can be inserted in a single common entry site through the same head unit. 8. The head unit of claim 7, wherein the head unit is a plurality of implanted parts, a shaft containing these parts, or a connector between the devices, wherein the head unit contains one or more additional part (s) or shafts containing these parts. Direct communication, connection, or power between the additional component (s) or shaft (s) and the first shaft by allowing direct electrical contact between the first shaft of the device inserted through the common entry site (s). The device of which delivery is permitted. The device of claim 1, wherein the effect comprises one or more of the following: electrical stimulation or electrical disturbance of the target site; Mechanical stimulation or mechanical disturbances at the target site; Change in temperature at the target site; Magnetic field induction at the target site; Photostimulation or photoinhibition at the target site, including the use of lasers and light control to stimulate or inhibit progression at the target site; Ultrasonic stimulation or ultrasonic disturbance of the target site; Induction of vibrations delivered to the target site, including sonic vibrations that are delivered to and activate the auditory receptor; Generation and regulation of electric fields for ionophoresis or iontophoresis at the target site; And irradiation of the target site. The device of claim 1, wherein the data collected comprises one or more of the following: monitoring of signals from single neurons and groups of neurons; Monitoring of intracranial pressure; Monitoring of physiological signals; Monitoring of metabolic activity and other signals of tissues including neurons, glial cells, blood cells, immune cells, and other cells; Monitoring of signals derived from cellular and subcellular parts, including proteins, DNA, RNA, molecules, neurotransmitters, hormones and mitochondria; Electrolytes, proteins, hormones, amino acids, molecules, carbohydrates, minerals, fatty acids, osmolarity, osmolality, pharmaceuticals, radioactive tracers, light, electromagnetic energy, fluorescence, radiation, and other measurable items Measurement of components, state of matter, or physical properties in the body, including; Monitoring of optical, fluorescence, ultraviolet, infrared, and / or birefringent signals, and / or changes thereof emitted from tissues including neurons, glial cells, blood cells, other cells, blood vessels and cerebrospinal fluid; And / or monitoring the temperature of tissues and their changes The apparatus of claim 1, wherein each said shaft has similar or different physical properties to the other shaft and includes the following characteristics: a straight line; curve; Curve along the contour curvature of the bone or skull; Spiral curves that fit into the body or skull through the entry site; Shape can change as it is inserted during insertion; Stiffness; At least partially flexible; Change between stiffness and flexible states; Sharp end; Blunt extremity; Extremities not sharp enough to penetrate the cortex bones; Non-externally curved curved ends that can be easily inserted into a pre-made entry site; Threaded, configured to screw into position; Made of a selective permeable material that differentially absorbs, delivers, repels, and elutes different molecules; Made of a selective permeable material comprising embedded cells; And / or a selective permeable material that is a nanoporous mesh The device of claim 1, having at least one actuator, the actuator being contained within a protective housing and capable of stimulating tissue by transferring energy through the housing. The device of claim 1, having at least one actuator or sensor, the actuator or sensor protruding from an end of the shaft, or located at a surface of the shaft.

Images