专利摘要:
conductor and kit for modulating tissue stimulated in a patient's body an implantable wireless conductor includes an enclosure, the enclosure housing: one or more electrodes, configured to apply one or more electrical pulses to a neural tissue; a first antenna configured to receive, from a second antenna and through electrical radioactive coupling, an input signal containing electrical energy, the second antenna being physically separated from the implantable neural stimulator conductor; one or more circuits electrically connected to the first antenna, the circuits being configured to create one or more electrical pulses suitable for stimulation of the neural tissue, using the electrical energy contained in the input signal; and supplying one or more electrical pulses to one or more electrodes, where the envelope is shaped and arranged to deliver, to a patient's body, through an introducer or a needle.
公开号:BR112013025521B1
申请号:R112013025521-8
申请日:2012-04-04
公开日:2021-04-13
发明作者:Patrick Larson;Chad Andresen;Laura Perryman
申请人:Micron Devices Llc;
IPC主号:
专利说明:

Field of the Invention
The present invention relates to implantable neural stimulators. History of the Invention
A wide variety of therapeutic techniques for intracorporeal electrical stimulation can treat neuropathic conditions. These techniques may use a battery operated subcutaneous implantable pulse generator (IPG), connected to one or more wired implantable conductors. These conductors have numerous failure modes, including mechanical displacement, impacts to the conductor / extension tube, infection and uncomfortable irritation from the IPG and the extension tube. Several types of spinal cord stimulation (EME) conductors have been used to provide therapeutic pain relief. These conductor configurations generally include percutaneous cylindrical conductors and diamond-shaped conductor models. Percutaneous cylindrical conductors typically have diameters in the range of 1.3 mm and contain a series of circular electrodes used for efficiency testing during an implant test period and, in many cases, for permanent implantation. Lozenge conductors, however, contain electrodes with a larger surface area, directionally oriented to control the excitation of nerve bundles and may require surgical laminotomy. Brief Description of the Invention
Some embodiments feature an implantable neural stimulator wireless conductor. The wireless conductor includes: a housing; such a housing housing: a) one or more electrodes, configured to apply one or more electrical pulses to a neural tissue; b) a first antenna, configured to receive from a second antenna, through electrical radioactive coupling, an input signal containing electrical energy, the second antenna being physically separated from the implantable neural stimulator conductor; c) one or more circuits electrically connected to the first antenna, such circuits being configured to create one or more electrical pulses suitable for stimulation of the neural tissue using the electrical energy contained in the input signal, and to supply one or more electrical pulses to one or more electrodes, where the casing is shaped and electrical pulses for one or more electrodes, where the casing is shaped and arranged to deliver, to a patient's body, through an introducer or a needle.
Configurations can include one or more characteristics. For example, a part of the wrapper may leave the electrodes in non-direct contact with the neural tissue, after the conductor has been delivered to the patient's body. The shell may be semicylindrical in shape and the electrodes may include at least one directional electrode that directs a current path associated with one or more electrical pulses in a substantially perpendicular direction, with respect to the neural tissue. The electrodes may include a semi-cylindrical set of electrodes. The electrodes can be made from at least one of the following materials: platinum, platinum / iridium, gallium nitride, titanium nitride, iridium oxide, or combinations thereof. The electrodes can include two to sixteen electrodes, each with a longitudinal extension between 1.0 and 6.0 mm and a width between 0.4 and 3.0 mm. The electrodes are spaced between 1 mm to 6 mm and have a combined surface area between 0.8 mm2 to 60.00 mm2.
The conductor may be a diamond-shaped conductor. Specifically, the conductor may be a diamond-shaped conductor with a height between 1.3 mm and 2.0 mm, and a width between 2.0 mm and 4.0 mm. The driver may have a concave shape to secure a lateral position of the neural tissue, after the driver has been delivered to the patient's body. The lateral position may be relative to a dorsal aspect of the patient's spinal cord. For example, the conductor has a profile between 1.0 mm and 1.5 mm, and a concave edge between 0.2 mm and 0.3 mm.
The driver can be delivered to an epidural space of the patient's body. Delivery can be made through a needle, such as, for example, a Tuohy needle, no larger than 14 gauge. The conductor can be delivered to treat neural tissue associated with the spine.
The housing can also accommodate a lumen for operating a guide catheter during delivery of the housing. The casing may also include a distal tip. The distal tip can be rounded, with an extension between 0.5 mm and 2.0 mm. The distal tip can also be pointed, with an extension between 2.0 and 6.0 mm.
The shell may have an outer coating of biocompatible polymer, the polymer containing at least one of these components: polymethylmethacrylate (PMMA), polydimethylsiloxane (PDMS), parylene, polyurethane, polytetrafluoroethylene (PTFE), or polycarbonate. The housing may also have an external silicone elastomer coating. The housing can also house antenna coupling contacts, the antenna contacts being electrically connected to the antennas and the circuit and configured to couple the antenna with the surrounding tissue. The antenna coupling contacts can include two to eight pairs of antenna couplings. The antenna coupling contacts can be positioned proximally, with respect to the electrodes, in the housing. The antenna coupling contacts can each have a longitudinal extension between 1.0 mm and 6.0 mm and a width between 1.0 mm to 2.5 mm. The antenna coupling contacts can be spaced between 30 mm and 80 mm. At least one of the antennas can be constructed as a conductive trace contained in one of the circuits. At least one of the antennas can be manufactured as a conductor wire connected to one of the circuits. The circuits may be flexible circuits. Flexible circuits must be capable of being subjected to a bending radius of less than 0.5 mm. The flexible circuits can be installed proximally, with respect to the electrodes, in the enclosure. Flexible circuits may include a wavelength conditioning circuit.
Some embodiments present a method for treating neurological pain. The method includes: providing an implantable neural stimulating conductor, including a housing that houses: one or more electrodes; a first antenna configured to receive from the second antenna and through electrical radioactive coupling, an input signal containing electrical energy, the second antenna being physically separated from the implantable neural stimulator conductor; one or more flexible circuits electrically connected to the first antenna, the flexible circuits configured to: create one or more electrical pulses suitable to be applied to the electrodes using the electrical energy contained in the input signal; and providing one or more electrical pulses for one or more electrodes, and implanting the neural stimulation conductor in the patient's body, through an introducer or a needle.
The embodiments may include one or more of the following characteristics. For example, a part of the wrapper may leave the electrodes in non-direct contact with the neural tissue after the conductor has been implanted in the patient's body. The electrodes may include at least one directional electrode that confines a current path associated with one or more electrical pulses in a direction substantially perpendicular to the neural tissue. The needle may be a Tuohy needle no larger than 14 gauge. Description of Drawings
Figure 1 illustrates two wireless rhomboid conductors being implanted, through an introducer, into the epidural space.
Figure 2 illustrates a wireless diamond-shaped conductor being implanted, through an introducer, into a human body.
Figure 3 illustrates a wireless diamond-shaped conductor positioned against the dura mater of the spinal cord.
Figure 4A illustrates an example of an introducer.
Figure 4B shows a cross-sectional view of the introducer shown in Figure 4A.
Figure 5A illustrates another example of an introducer.
Figure 5B shows a cross-sectional view of the introducer shown in Figure 5A.
Figure 6A illustrates the distal tip of a wireless diamond-shaped conductor.
Figure 6B shows cross-sectional views of the distal ends of three configurations of a wireless diamond-shaped conductor.
Figures 7A and 7B illustrate, respectively, the dorsal and ventral sides of a wireless diamond-shaped conductor configuration.
Figure 7C illustrates the ventral side of another configuration of the wireless diamond-shaped conductor.
Figure 8 illustrates a configuration of a cylindrical and semi-cylindrical wireless conductor being placed in the epidural space, by means of a needle.
Figure 9 illustrates an example of a wireless cylindrical or semi-cylindrical conductor being implanted in the epidural space, using a needle.
Figure 10 illustrates a cylindrical or semi-cylindrical cordless conductor positioned against the dura of the spine.
Figures 11A - 11C illustrate cross-sectional views of a semi-cylindrical conductor, a cylindrical conductor and a diamond-shaped conductor, respectively, while these conductors are positioned against the dura.
Figures 12A - 12B illustrate perspective and profile views, respectively, of a wireless semi-cylindrical conductor configuration.
Figures 13A - 13C illustrate in a variety of ways the electronic components included in two wireless conductor configurations.
Figures 14A - 14B illustrate a cross-sectional view of a wireless cylindrical conductor or a complete wireless semicylindrical conductor.
Figure 14C illustrates a cross-sectional view towards the distal end of a cordless semi-cylindrical conductor.
Figure 15 illustrates a wireless cylindrical conductor configuration. Detailed Description of the Invention
Spinal cord stimulation can treat chronic neuropathic pain, especially low back pain and radiculopathies, vascular insufficiency in the feet or hands, angina, and others. In different implementations, a neural stimulation system can send electrical stimuli to the target nervous tissue without cables or inductive couplings to energize the passive implanted stimulator. This can be used to treat pain or a variety of other modalities. The target nerve tissues can be, for example, in the spine, including the spinothalamic tracts, dorsal horn, dorsal root ganglia, dorsal roots, dorsal spine fibers and peripheral nerve bundles leaving the dorsal spine or brain stem, as well such as any cranial, abdominal, thoracic or trigeminal ganglion nerves, nerve bundles in the cerebral cortex, deep brain, and any sensory or motor nerves.
The neural stimulation system may include an implantable conductor that includes a housing that houses one or more conductive antennas (such as, for example, dipole antenna or Patch antenna), internal circuits for waveform frequency and rectification of electrical energy, and one or more electrode pads, allowing neural stimulation of the tissue. The neural stimulation system can receive microwave energy from an external source. The implantable conductor may have a diameter of 1.3 mm or smaller. Particular implementations of circuits, antennas and pads are described in PCT Order PCT / US2012 / 023029, which are incorporated by reference.
In various embodiments, the implantable conductor is energized “wirelessly” (and therefore does not require a cable connection) and contains the circuits necessary to receive pulse instructions from an external source, with respect to the body. For example, several configurations employ an internal dipole (or other) antenna configuration or configurations to receive RF energy through electrical radioactive coupling. This may allow such conductors to produce electrical currents capable of stimulating nerve bundles without a physical connection to an implantable pulse generator (IPG) or the use of an inductive spring. This can be advantageous with respect to designs that employ inductive springs to receive RF energy through inductive coupling and then transfer the received energy to a large IPG device for recharging, especially if the large IPG device for recharging is as large as 100 mm x 70 mm.
In addition, the electric radioactive coupling mechanism (a dipole antenna, for example) can be used to enhance the model of a wireless conductor and allow miniaturized diameters, as small as 30 microns. For example, some wireless conductor implementations, such as those discussed in association with Figures 7-15, can have diameters of less than 1.3 mm, and as small as 500 microns, yet providing the same functionality as the wired spinal cord stimulation conductors.
The radiative electric coupling also allows transmission and reception of energy at greater depths with less efficiency degradation than the inductive spring techniques. This can provide an advantage over devices that employ inductive coupling, since the efficiency of such implants is highly dependent on the distance that separates the external transmitting coil and the internal receiving coil.
Various configurations may also include distinct advantages over wired conductors, with regard to ease of insertion, cross connections, elimination of extension cables, and no need for implantable pulse generators to deliver chronic therapies. Several implementations may also have a lower associated overall cost, compared to existing implantable neural modulation systems, due to the elimination of the implantable pulse generator, and this may lead to a wider adoption of neural modulation therapy for patients, as well as a reduction in the overall costs of the health system.
Figure 1 illustrates two wireless diamond-shaped conductors (200) (described in more detail, below) being implanted through an extended-width introducer (202) into the epidural space. A conductor (200) can be advanced and guided in the epidural space, using the extension tube (201) with a handle for manipulating the conductor (200). The introducer (202) has an entry point (100) above the lumbar spine (103) (shown in Figure 2). Once the introducer (202) is removed, the wireless diamond-shaped conductor (200) can be anchored in place, subcutaneously, at the entry point (100). After that, the extension tube (201) can remain implanted and operate from the positioning point on the skin to the wireless diamond-shaped conductors (200).
In some configurations, the tube (201) contains a lumen for a stylus (also referred to as an “injector lead”, a “guide wire”, a “navigation wire” or a “steering wire”), which can be used to position the conductor (200). The stylus can be made of metal and provide driving force during the implantation of the wireless diamond-shaped conductor (200). After the wireless diamond conductor (200) has been successfully implanted, the metal stylus can be removed. As will be discussed with reference to Figure 7C, this lumen, or other lumens in the tube (201), can also be used to house electronic circuits.
Figure 2 illustrates a wireless diamond-shaped conductor (200) being positioned, through an introducer (202), typically in the lumbar region, between the L1 and L2 vertebrae. For example, the introducer (202) can be inserted through a small incision in the skin (105) and between the vertebrae (103). In certain configurations, multiple wireless diamond-shaped conductors (200), wireless cylindrical conductors (400) (as will be discussed, with reference to Figures 8 - 15) and wireless semi-cylindrical conductors (300) (as will be discussed, with reference to Figures 8-15) can be inserted through the same channel as the introducer (202). Wireless diamond-shaped conductors (200), cylindrical conductors (400) or semi-cylindrical conductors (300) for spinal cord stimulation applications can then be implanted and positioned against the dura (104) of the spine (102), as described in association with Figure 3, below.
In certain configurations, wireless diamond-shaped conductors (200), cylindrical conductors (400) or semi-cylindrical conductors (300) may be adapted to be located within the epidural space of the spine, near or in the vertebral column's own dura, in tissues in close proximity to the spine, in tissues located near the dorsal horn, dorsal root ganglia, dorsal roots, dorsal spine fibers and / or bundles of peripheral nerves exiting the dorsal spine.
In certain configurations, wireless diamond-shaped conductors (200), cylindrical conductors (400) or semi-cylindrical conductors (300) can be adapted to be positioned and attached to stimulate nerves that come out of the spine to treat a number of conditions, such as, for example, pain, angina, peripheral vascular diseases, gastrointestinal disorders. In other configurations, wireless diamond-shaped conductors (200) can be adapted to treat other conditions, through neural stimulation of the nerve bundles emanating from the spine. “Spinal cord tissue” and “nerve bundles emanating from the spine” generally refer, without limitation, to nerve bundles ranging from the levels of spine C1 to L5, dorsal horn, dorsal root ganglia, dorsal roots, dorsal spine fibers and peripheral nerve bundles exiting the dorsal spine.
Figure 3 illustrates a wireless diamond-shaped conductor (200) positioned against the dura mater (104) of the spinal cord, after it has been implanted in the human body for spinal cord stimulation applications. The small skin incision (105) can be closed with a sterile suture or bandage, after placing the anchoring mechanism (106). The wireless diamond-plated conductors shown here may have electrodes that confine the current path in a direction usually perpendicular to the dura, as will be discussed with reference to Figure 11C. This directionality may be desirable to focus on a specific target tissue and to reduce electrical charges for effective stimulation.
Figure 4A illustrates an example of an introducer (214) that can be accommodated between two vertebrae, without the need for surgical laminotomy or removal of any bone tissue. The introducer (214) includes a handle (212) for use by medical personnel during the insertion procedure. The width of each handle can be between approximately 8 mm and approximately 15 mm. The length of each handle can be between approximately 10 mm and approximately 18 mm. The thickness of the handle can be between approximately 2.5 mm and approximately 6 mm. The introducer (214) has an internal channel (215) that can accommodate, for example, two wireless diamond conductors (200) positioned one at a time, sequentially, through the same introducer channel. As illustrated, the example wireless diamond conductor (200) has a flattened tip.
Figure 4B shows a cross-sectional view of the introducer shown in Figure 4A. This cross-sectional view can also be known as a profile view.
Figure 5A illustrates another example introducer (214) that can be adapted through the vertebrae without the need for a surgical laminotomy or removal of any bone tissue. The introducer (214) includes a handle (212) for use by medical personnel during the insertion procedure. The introducer (214) has an internal channel (217) which can accommodate, for example, two simplified models of wireless diamond-shaped conductors (220) positioned on top of each other. The two simplified wireless diamond wire models (220) can be stacked vertically in the inner channel (217) at the same time. As illustrated, the example wireless diamond-shaped conductor (220) may be a sharp point (219) that will help direct the diamond-shaped conductor through the small epidural space of a minor patient. The example wireless diamond wire (220) may also have a flattened tip that helps to seat the electrode columns in parallel with the spine, from a fluoroscopic view or a rounded tip that helps to seat the electrode columns in parallel with the spine, and direct the rhomboid conductor through the epidural space.
Figure 5B shows a cross-sectional view of the introducer shown in Figure 5A. This cross-sectional view can also be known as a profile view.
Figure 6A illustrates the distal tip of a wireless diamond-shaped conductor (200). The wireless diamond-shaped conductor (200) may include, for example, four electrodes (203) and the spacers between the electrodes. The wireless diamond-shaped conductor (200) may include two to sixteen electrodes (203) located at the distal end of the conductor (not shown). The distal tip may have a height between approximately 1.3 mm and approximately 2.0 mm, and a width between approximately 2.0 mm and approximately 4.0 mm. The electrodes (203) may have a longitudinal length between approximately 1.0 mm and approximately 6.0 mm from the distal tip, towards the proximal tip and a width between approximately 0.4 mm and approximately 3.0 mm. The total electrode surface area of the conductor (200) may be between approximately 0.8 mm2 and approximately 60.0 mm2. The spacing between the electrodes (203) may be between approximately 1 mm and approximately 6 mm from the distal to the proximal.
The various conductors described here may include anywhere from one to sixteen electrodes, each of which may be designated by the programmer as a cathode or anode. For example, the electrodes (203) can include multiple cathodes coupled to the target tissue, as well as at least one anode. The electrode array can receive electrical stimulation waveform pulses ranging from 0 to 10 V peak amplitude to a pulse width that reaches a maximum of 1 millisecond. The polarity of the electrodes may produce various volume conduction distributions from the cathodes to the anodes, to inhibit or excite the surrounding nervous tissue, which may include primary or secondary fiber afferents and / or A-δ. To minimize the electrode impedance, the electrodes may be made of a conductive, corrosion resistant, biocompatible material, such as, for example, platinum, platinum / iridium, gallium nitride, titanium nitride or iridium oxide.
Excluding the electrodes (203), which are coupled to the surrounding tissue, the remaining parts of the wireless conductor configurations described here can be isolated from the surrounding body tissue, partially or totally, by a layer of external coating of biocompatible dielectric material with low constant dielectric. Materials with tissue-like stiffness can be used to reduce the risk of migration and the development of fibrous scar tissue. This fibrous scar tissue may increase the electrode / tissue impedance. If the electrode / tissue impedance can be kept low, less energy will be consumed to obtain stimulation of the target tissues.
In certain configurations, the wireless diamond-shaped conductor (200) may have a rounded tip (211) at the distal end. The rounded tip (211) may be a non-conductive tip. The rounded tip (211) may have a length between 0.5 mm and 2.0 mm, and a smooth finish, to guide the driver through the epidural space.
In certain configurations, the wireless diamond-shaped conductor (200) may have a sharp tip (219) at the distal end. The sharp tip (219) may be a non-conductive tip. The sharp tip (219) may be between approximately 2.0 mm and approximately 6.0 mm in length. The sharp tip (219) can improve the steering ability when the wireless diamond driver (200) is being implanted.
Figure 6B shows the cross-sectional views of the distal end of three configurations of a wireless diamond-shaped conductor. For example, in certain configurations, the wireless diamond wire (200) may be a slimmer model of the wireless diamond wire (220). As illustrated in
Figure 6B, the slimmer model of the wireless diamond-shaped conductor (220) may be thinner than an ordinary wireless diamond-shaped conductor (221). For example, the thinner wireless wireline conductor may be between approximately 1.0 mm and approximately 1.3 mm in height, which will allow multiple thinner wireless wireline conductors to be implanted simultaneously or sequentially through of an introducer (214). For example, in certain configurations, the wireless diamond-shaped conductors (200) may be a thinner concave wireless diamond-shaped conductor (207), with a concave profile between approximately 1.0 mm and 1.5 mm and concave edges between approximately 0.2 mm and approximately 0.3 mm. The concave profile may refer to the height of the thinner concave wireless diamond-shaped conductor (207). The concave edge may refer to the dimension of the concave corner of the thinner concave wireless wired model (207). The thinner concave wireless diamond cable (207) can be positioned as close as possible to the spine.
In certain configurations, at least one additional wireless conductor may be installed in parallel or offset from the initial wireless conductor. In some configurations, wireless conductors may be sequentially activated. In other configurations, the wireless conductors can be activated simultaneously.
Figures 7A and 7B illustrate the dorsal and ventral sides of the implementation of a wireless diamond-shaped conductor (200) respectively. In one example, electrodes (203) and between two to eight antenna coupling contacts (222) can be positioned on different sides of the wireless diamond wire (200). As discussed with reference to Figure 6A, two to sixteen electrodes (203) can be positioned at the distal end and incorporated into the electrically insulating material (205) of the wireless conductor (200).
For example, the antenna (208) can be coupled to the fabric through the antenna coupling contacts (222) located on the ventral side of the wireless diamond-shaped conductor (200). The antenna may be, for example, a dipole antenna. Some configurations may have only one dipole antenna, other configurations may have multiple antennas of any given length.
For example, without limitation, some configurations may have between two and ten dipole antennas, while other configurations may have more than ten dipole antennas or more than twenty dipole antennas. In some configurations, a dipole antenna can range from approximately 100 microns to approximately 10 cm in length. In other configurations, an antenna may consist of any linear dipole configuration ranging from approximately 20 microns to approximately 3 mm in thickness. The antenna (208) may also be a folded dipole antenna, instead of a straight dipole antenna.
The antenna (208) can be configured to receive RF energy from external antennas The RF wave propagation energy is divided into two regions, the radioactive region and the reactive region. The radioactive region is within 2D2 / X and the radiated power varies with the distance from the antenna. For a short dipole antenna, the reactive component will be approximately X / 2π. The induced field for antennas positioned on biological tissue is a function of body geometry, tissue properties and exposure conditions. The efficiency of the RF waveform within a lossy medium, such as body tissue, is attenuated by the tissue as it propagates. To increase the power efficiency of a small antenna in matter subject to losses, the configuration of the dipole antenna can be optimized at high frequencies to minimize losses, such as, for example, from approximately 800 MHz to 5.8 GHz or more.
The antenna coupling contacts (222) in certain configurations may have a longitudinal extension between approximately 1.0 mm and approximately 6.0 mm from the distal tip, towards the proximal tip, and a width between approximately 1.0 mm approximately 2.5 mm. The spacing between the antenna coupling contacts (222) can be between approximately 30 mm and approximately 80 mm. The antenna coupling contacts (222) may improve the efficiency of the radioactive coupling between the internal antenna (208) and the antenna (s) (not shown) located externally, with respect to the body. The antenna coupling contacts (222) may be made of non-corrosive metals, such as, for example, platinum, platinum / iridium, gallium nitride, titanium nitride or iridium oxide.
The antenna coupling contacts (222) can be connected by means of conducting wires (210) to the antenna (s) (208) and the waveform conditioning circuit (209). The waveform conditioning circuits (209) may include, for example, electronic components, such as, for example, diodes, resistors and capacitors. The waveform conditioning circuits (209) can use the incoming energy to provide a stimulation waveform of the electrodes for excitation of the nerve tissue. In some configurations, frequencies from approximately 800 MHz to approximately 5.8 GHz can be received by the implanted antenna (208). The stimulatory waveform released into the tissues by the electrodes (203) is rectified to provide waveforms at lower frequencies, such as, for example, at typically approximately 5 Hz to approximately 15 1000 Hz.
The waveform conditioning circuits (209) are configured to rectify the waveform signal received by the implanted antenna (208). Waveform conditioning circuits (209) can also have charge balance microelectronics to prevent corrosion of the 20 electrodes. To minimize the reflection of energy, back from the electrodes to the circuits, waveform conditioning circuits (209) may include isolation circuits to block high frequency signals.
Figure 7C illustrates the ventral side of another configuration of a wireless diamond-shaped conductor (200), where the implanted antenna (208) is separated from the distal end (205) of the wireless diamond-shaped conductor (200). In some configurations, the implanted antenna (208) may be implemented remotely, from the distal end (205) of the wireless diamond-shaped conductor (200) and within a lumen, in the extension tube (201) within the conductive body. In some configurations, the deployed antenna (208) may be the extension line for one of the 30 antenna coupling contacts (304). In some configurations, the antenna coupling contacts (304) may be located close to the electrodes (203). The antennas (208) may also be connected to the waveform conditioning circuits (209) using shielded cables (210). The waveform conditioning circuits (209) can be directly wired to the electrodes (203) (located on the ventral side).
In some configurations, the wireless conductors described here may have multiple layers. These layers may include, without limitation, coating material, close to the electrodes, with a biocompatible compound that induces the minimum formation of scar tissue. In addition, the layers may include polymers, such as, without limitation, polymethylmethacrylate (PMMA), polydimethylsiloxane (PDMS), parylene, polyurethane, polytetrafluoroethylene (PTFE) or polycarbonate. Another layer of a material containing little relative permeability and low conductivity may be located above the antennas (208) to allow optimal coupling with an external antenna (not shown). Another layer may comprise a silicone elastomer coating to help prevent migration of the wireless conductor to the surrounding tissue.
Figures 8 and 9 illustrate an example of a wireless cylindrical conductor (400) or a wireless semicylindrical conductor (300) being implanted in the epidural space, using needles (301). Wireless cylindrical conductors can also be referred to as circumferential conductors, while wireless semi-cylindrical conductors can also be referred to as semi-circumferential or semi-elliptical wireless conductors. Wireless cylindrical conductors (400) or wireless semi-cylindrical conductors (300) can be introduced into the body through a needle (301). The needle (301) may be a Tuohy needle, 14 gauge or smaller (22 gauge, for example). Alternatively, the wireless conductors (300) and (400) can be introduced into the epidural space, through an introducer (202) (see, for example, Figure 1). The introductors (202) or the needle (301) can be inserted through the outer skin of the body, through a small incision in the skin (105) and between the vertebrae (103) at an angle no greater than 45 degrees, lateral to the spinal processes outside the midline, and positioned against the dura (104) of the spine (102) to rest perpendicularly, in relation to the spinal cord. The wireless conductors (300) or (400) may contain extension tubes (201) that terminate just under the entry point (100) of the skin. The wireless conductor can be guided upwards in the epidural space, according to the angle of the introducer or needle insertion. After installing the wireless conductor, a subcutaneous anchor is used to stop the vertical and horizontal migration of the wireless conductor.
Figure 10 illustrates configurations of a wireless cylindrical conductor (300) or wireless semi-cylindrical conductor (400), after they have been implanted. A cylindrical (300) or semi-cylindrical (400) cordless conductor can be positioned against the dura (104) of the spinal cord and the small skin incision (105) will be closed with a sterile suture or bandage, after positioning the mechanism anchoring (106).
Figures 11A - 11C illustrate, respectively, the cross-sectional views of the positioning of a wireless semi-cylindrical conductor (300), a wireless cylindrical conductor (400), and a wireless diamond-shaped conductor (200), after successful implantation , in relation to the dura mater (104) of the spinal cord (101).
Figure 11A shows the positioning of a wireless semi-cylindrical conductor (300) with respect to the dura mater (104) of the spinal cord (101). The wireless semicylindrical conductor (also referred to as circumferential or elliptical half) (300) may have straight electrodes, as shown in Figure 12A, or concave and half cylindrical. Semi-cylindrical electrodes can follow the shape of the enclosure. The semi-cylindrical shape of the driver's casing (300) can help the driver to mechanically conform the contour of the spine (102). The shape of the wrapper can also help guide the conduction of the electrical volume inwards, towards the dura (104), and prevents the irradiation of energy outwards, towards the ligaments, vertebrae and skin (non-excitable tissues). More generally, the conductive field generated by the electrodes is unidirectional in nature, because the conductive field culminates mainly in the housing, and the faces of the electrode point in the same direction. By removing the unnecessary emission of more than 270 degrees from a cylindrical electrode (see, for example, Figures 14B and 15) that radiate towards the non-excitable tissue, the wireless semicylindrical conductor (300) can reduce the amount of energy required for successful stimulation. In this way, the benefits of the exemplary wireless semi-cylindrical conductor (300) may include the directional delivery of stimulation energy, as confined by the shape of the electrode.
Figure 11B shows the positioning of a cordless cylindrical conductor (400) with respect to the dura mater (104) of the spinal cord (101), after a successful implantation. As shown, the wireless cylindrical conductor (400) is positioned against the dura (104).
Figure 11C shows the positioning of a wireless diamond-shaped conductor (200) in relation to the dura mater (104) of the spinal cord (101) after a successful implant. As shown, the wireless diamond-shaped conductor (200) is positioned against the dura (104). The wireless diamond-shaped conductor (200) may have electrodes that confine the current path in a direction generally perpendicular to the dura. This directionality may be desirable to focus on a specific target tissue and to reduce electrical charges for effective stimulation.
Figures 12A and 12B illustrate perspective and profile views, respectively, of the implantation of a semicylindrical wireless conductor (300). The semi-cylindrical conductor (300) may, in certain configurations, have between two and sixteen electrodes (203) at the distal end (205), each with a diameter typically between approximately 0.8 mm and approximately 1.4 mm, and concave ventral aspects with bending radii typically between approximately 0.6 mm and approximately 3.0 mm. The electrodes (203) may have longitudinal extensions between approximately 1.0 mm and approximately 6.0 mm from the distal tip, towards the proximal tip, with widths typically between approximately 0.4 25 mm and approximately 1.0 mm. The total electrode surface area of the wireless conductor (300) is typically between approximately 0.8 mm2 and approximately 60.0 mm2. The spacing between the electrode contacts is typically between approximately 1.0 mm and approximately 6.0 mm. The distal tip of the conductive body may be a pointed non-conductive tip, with an extension between approximately 0.5 mm and approximately 2.0 mm, and a smooth finish to guide the conductor through the epidural space.
The wireless semi-cylindrical conductor (300) may include between two to eight antenna coupling contacts (304), as illustrated in association with Figure 7C, wired to the implanted antenna (s) (208) and the flexible circuits (206) (as illustrated in association with Figures 12 and 13). The antenna coupling contacts (304) can be proximal to the electrodes (203). The antenna coupling pads (304) may have a longitudinal extension between approximately 1 mm and approximately 6 mm, from the distal tip to the proximal tip. The spacing between the antenna coupling contacts (304) is typically between 30 mm and 80 mm. In some configurations, small antenna coupling contacts (303), to be discussed in association with Figure 13C, can be used. The antenna coupling contacts (303) may have a diameter between approximately 0.2 mm and approximately 0.6 mm.
The configurations of wireless conductors described here may have a larger surface area, directed against the dura mater, than that of existing percutaneous conductors. This increased surface area can lower the tissue to electrode impedance values and lead to higher currents, for stimulation.
Figures 13A - 13C variously illustrate electronic components included in two different configurations of the wireless conductor, specifically, a wireless semicylindrical conductor (300) and a wireless cylindrical conductor (400).
Figure 13A shows an exemplary wireless conductor (such as a wireless semi-cylindrical conductor (300) or a wireless cylindrical conductor (400)) with an extension tube (201). The tube (201) can house electrodes (203), an implanted antenna (208), waveform conditioning circuits (209) and wires (210). As discussed above, in association with Figures 7A - 7B, the waveform conditioning circuits (209) may include components for rectifying the received RF energy and for balancing the waveform's load for tissue stimulation.
One or more flexible circuits (206) can be used to transport different parts of electronic components. For example, the 19 flexible circuits (206) may include the waveform conditioning circuits (209) and the implantable antenna (s) (208). The flexible circuit can also include parts of the wires (210) that connect the electronics (such as the circuits (209)) to the electrodes (203). The flexible circuits (206) may be between 5 approximately 15 mm and approximately 90 mm long, and approximately 0.7 mm and approximately 2.0 mm wide. The total height of the flexible circuit (206), with the waveform conditioning circuits (209), can be between approximately 0.2 mm and approximately 0.4 mm. The flexible circuit (206), when positioned inside the cordless cylindrical conductor io (400), can be subjected to a bending radius less than approximately 0.5 mm. As illustrated in Figure 13A, in some configurations, the flexible circuit (206) may contain a conductive trace to act as an antenna (208).
Figure 13B shows another example of a wireless conductor (such as a wireless semi-cylindrical conductor (300) and a wireless cylindrical conductor (400)) encapsulated, which includes a tube (201). The tube houses the antenna (s) (208) and the waveform conditioning circuits (209), which will both be formed into a flexible circuit (206) similar to the flexible circuit described in relation to Figure 13A. At least a part of the wires (210) may be formed in the flexible circuit as well. The wires (210) connect, for example, the circuits (209) to the electrodes (not shown in Figure 13B). Wires 210 also connect the antenna (208) to the exposed fabric circular antenna coupling contacts (304). The exposed fabric circular antenna coupling contacts (304) can be circumferential rings with an outside diameter between approximately 25 0.8 mm and approximately 1.4 mm, and longitudinal extensions between approximately 0.5 mm and approximately 6.0 mm.
Figure 13C shows yet another exemplary wireless conductor (such as a wireless semi-cylindrical conductor (300) and a wireless cylindrical conductor (400)) with an extension tube (201). The extension tube (201) houses the antenna (s) 30 (208) and the waveform conditioning circuits (209), which can both be formed in a flexible circuit (206) similar to the flexible circuit described in relation to Figure 13A. At least a part of the wires (210) can be formed in the flexible circuit as well. The wires (210) connect, for example, the circuits (209) to the electrodes (not shown in Figure 13C). The wires (210) also connect the antenna (208) to the antenna coupling contacts of small exposed fabrics (303). The small exposed fabric antenna coupling contacts 5 (303) can be made of a piece of conductive cylindrical metal, between approximately 0.2 mm and approximately 0.6 mm in diameter and between approximately 0.2 mm and approximately 0 mm in diameter. , 6 mm. The small exposed fabric antenna coupling contacts (303) can contact the fabric and can be incorporated into the electrically insulating material io (205).
Figure 14A illustrates the cross-sectional view of the configuration of a wireless cylindrical conductor (400) or a complete wireless semi-cylindrical conductor (300), in a proximal position with respect to the distal tip. The configuration shown is an extrusion of multiple lumens (305), having a central lumen 15 (204) and multiple orbital lumens (306) (e.g., one to ten, or more). The extrusion of multiple lumens (305) can be proximal, with respect to the extrusion of a single lumen (307), shown in the graph on the right, in a wireless conductor (for example, a wireless cylindrical conductor (400) or a conductor semicylindrical cordless (300) complete). The extrusion of multiple lumens (305) can act as a main support for guiding the conductive wires (210) housed in the lateral lumens (306), and a stylus (as discussed in association with Figure 1) positioned through the central lumen (204) . The plastic extrusion of multiple lumens (305) can be composed of one to ten, or more, orbital lumens (306), each with internal diameters between approximately 0.1 mm and approximately 0.6 mm. The plastic extrusion of multiple lumens (305) can have an outside diameter between approximately 0.8 mm and approximately 1.4 mm. In certain configurations, the extrusion of multiple lumens (305) may undergo an ablation (that is, be heated to be deformed) to a final outer diameter between approximately 0.6 mm and approximately 0.9 mm, which will allow 30 extrusion (305) can make male-female connections in a single lumen extrusion (307), as shown in the graph on the right. A guide catheter can be positioned inside the internal lumen (204) to guide the wireless conductor through the epidural space. The internal lumen (204) maintains a clean, unobstructed channel and can be fused with the single lumen extrusion (307) at the interconnection between the extrusions (305 and 307) and after the ablation mentioned above.
Figure 14B illustrates a cross-sectional view of another configuration of a complete wireless cylindrical conductor (400) or a complete wireless semi-cylindrical conductor (300), in a proximal position, with respect to the distal tip. This configuration is an extrusion of a single lumen (307), which may have an internal diameter between approximately 0.3 mm and approximately 1.4 mm. The single lumen extrusion (307) can be placed around the outside, for example, of the semicylindrical wireless conductor (300) and shaped by heat to reach an outside diameter between approximately 0.8 mm and approximately 1.4 mm. The single lumen extrusion (307) can leave enough empty space for the flexible circuit (206) to be encapsulated within it. The inner lumen (204) can be moved a distance 15 indicated by (308), within the single lumen (307) to provide an empty space for the flexible circuit (206). The conducting wires (210) of the side lumens (306) can connect to the terminal characteristics (not shown) of the flexible circuit (206). The empty space within the extrusion of a single lumen (307), between the flexible circuit (206) and the internal lumen (204), can be filled 20 with a biocompatible polymer, in order to add additional rigidity to protect the circuit components flexible (206) and conductive wires (210).
Figure 14C illustrates a cross-sectional view towards the distal end of a wireless semi-cylindrical conductor (300). For a wireless semi-cylindrical conductor (300), the concave multiple lumen extrusion (309) can accommodate the conductive wires (210) that run from the flexible circuit (206) to the electrodes (203). The concave shape of the multiple lumen extrusion (309) can allow the cordless semi-cylindrical conductor (300) to conform to the curvature of the spinal cord. The bending radius of the dorsal concave aspect is between approximately 0.6 mm and approximately 3.0 mm. The concave multiple lumen extrusion (309) 30 can contain between one and ten or more orbital lumens (306) acting as channels for the conductive wires, and a central lumen (204) for the stylet. The lumens (204) and (306) may have internal diameters between 0.1 mm and 0.6 mm. The orbital lumens (306) can be drilled from the dorsal side, during manufacture, in order to create channels for connecting the conductive wires (210) to the electrodes (203).
Figure 15 illustrates an example of a complete circumferential wireless conductor. The cordless cylindrical conductor (400) may have between two 5 and sixteen cylindrical electrodes (203) at its distal end, with a diameter between approximately 0.8 mm and approximately 1.4 mm, for spinal cord epidural stimulation applications. The electrodes (203) may have a longitudinal extension of between approximately 1.0 mm and approximately 6.0 mm, from the distal tip, towards the proximal tip. The spacing between the electrode contacts may be between approximately 1.0 mm and approximately 6.0 mm. The total electrode surface area of the wireless cylindrical conductor body (400) may be between approximately 1.6 mm2 and approximately 60.0 mm2. The distal tip of the cordless cylindrical conductor body (400) may be a rounded non-conductive tip, with a length of between approximately 0.5 mm and approximately 1.0 mm, with a smooth finish to make the conductor navigate through the space epidural. Between two to eight circular antenna coupling contacts of exposed fabric (304) can be proximal, with respect to the electrodes (203). The exposed fabric circular antenna coupling contacts (304) can have a longitudinal extension between approximately 1.0 mm and approximately 6.0 mm, from the distal tip, towards the proximal tip. The spacing between exposed fabric circular antenna coupling contacts (304) can be between approximately 30 mm and approximately 80 mm. In certain configurations, small exposed tissue antenna coupling contacts (303) with a diameter 25 between approximately 0.2 mm and approximately 0.6 mm can be used in place of the small exposed tissue antenna coupling contacts (303) illustrated. The extension tube (201), as discussed in connection with Figures 1, 7C, 8 and 9, can provide a housing that houses, for example, the flexible circuits (206). Flexible circuits (206) were discussed in association with Figures 13A to 13C. The extension tube (201) can include a central lumen (204). As discussed in connection with Figure 14A, a stylus 23 can be positioned through the central lumen (204) to guide the conductor (400), during implantation, through a lumen, for example, in the human body.
Several implementations of the technology may allow the positioning of the wireless conductor in the epidural space, between the dura mater and the 5 arachnoid membranes, or subdurally, in the intrathecal space, where significant reactions and scarring will be minimized. Insertion in any of these locations can be done by injecting the device from a smaller gauge needle (such as, for example, a 14 to 22 gauge needle, or from a cannula directed to the appropriate position by a removable stylus ). In some implementations, once in position, no further skin incision or positioning of implanted extensions, receptors or pulse generators will be required. Different implementations of the wireless neural modulation system may have significant advantages, due to the small size and absence of cables for energy transfer, allowing minimal trauma to the patient and effective therapy, in the long term, in places where larger implantable devices they could create more scar tissue and tissue reactions, capable of affecting efficacy and safety.
A number of implementations have been described. Even so, it should be understood that several changes can be made. Likewise, 20 other deployments will also be within the scope of the claims below.
权利要求:
Claims (33)
[0001]
1. WIRELESS IMPLANTABLE NEURAL STIMULATING CONDUCTOR, being free from an inductive coil, characterized by comprising: an enclosure including an extension tube (201) with a lumen (204), the lumen allowing to operate a navigation stylus during installation of the enclosure , the enclosure containing: - one or more electrodes (203) configured to apply one or more electrical pulses to a neural tissue; - a first antenna (208), the first antenna being a dipole antenna configured to: receive, from a second antenna and via radioactive electrical coupling, an input signal containing electrical energy, the second antenna being physically separated from the conductor of wireless implantable neural stimulator; - one or more circuits (209) electrically connected to the first antenna, the circuits (209) configured to: - create one or more electrical pulses suitable for stimulation of the neural tissue using the electrical energy contained in the input signal; and - providing one or more electrical pulses for one or more electrodes, in which the housing is shaped and arranged for distribution to a patient's body through an introducer or needle (214).
[0002]
2. DRIVER, according to claim 1, characterized by the fact that a portion of the wrapper leaves the electrodes in non-direct contact with the neural tissue after the electrode has been applied to the patient's body.
[0003]
3. CONDUCTOR, according to claim 1, characterized by the fact that the housing is semicylindrical in shape and the one or more electrodes includes at least one directional electrode whose shape is adapted to generate a unidirectional conductive field.
[0004]
4. CONDUCTOR, according to claim 3, characterized by the fact that one or more electrodes include a semi-cylindrical matrix of electrodes.
[0005]
5. DRIVER, according to claim 1, characterized by the fact that the electrodes are made of at least one of: platinum, platinum iridium, gallium nitride, titanium nitride, iridium oxide or combinations thereof.
[0006]
6. CONDUCTOR, according to claim 1, characterized by the fact that the electrodes include two to sixteen electrodes, each with a longitudinal length between 1.0 and 6.0 mm.
[0007]
7. DRIVER, according to claim 1, characterized by the fact that the electrodes are spaced between 1 mm to 6 mm and have a combined surface area between 0.8 mm to 60.00 mm.
[0008]
8. DRIVER, according to claim 1, characterized by the fact that the guide is of the shovel type.
[0009]
9. DRIVER, according to claim 8, characterized by the fact that it has a height between 1.3 mm and 2.0 mm and a width between 2.0 mm and 4.0 mm.
[0010]
10. DRIVER, according to claim 8, characterized by the fact that it has a concave shape to guarantee a lateral position in the neural tissue after the electrode has been applied to the patient's body.
[0011]
11. DRIVER, according to claim 10, characterized by the fact that the guide has a concave profile between 1.0 mm and 1.5 mm and a concave edge between 0.2 mm and 0.3 mm.
[0012]
12. DRIVER, according to claim 1, characterized by the fact that the needle is a tuohy needle.
[0013]
13. DRIVER, according to claim 1, characterized by the fact that the needle is not larger than 1.63 mm.
[0014]
14. DRIVER, according to claim 1, characterized by the fact that it also includes a distal tip.
[0015]
15. DRIVER, according to claim 14, characterized by the fact that the distal tip is rounded with a length between 0.5 and 2.0 mm.
[0016]
16. DRIVER, according to claim 14, characterized by the fact that the distal tip is pointed with a length between 2.0 and 6.0 mm.
[0017]
17. DRIVER, according to claim 1, characterized by the fact that the casing has an outer coating of biocompatible polymer, the polymer includes at least one of: polymethylmethacrylate (PMMA), polydimethylsiloxane (PDMS), parylene, polyurethane, polytetrafluoroethylene ( PTFE) or polycarbonate.
[0018]
18. DRIVER, according to claim 1, characterized by the fact that the casing also has an external silicone elastomer coating.
[0019]
19. CONDUCTOR, according to claim 1, characterized by the fact that the housing still houses antenna coupling contacts (222), the antenna contacts being electrically connected to the antennas and circuits (209) and configured to couple the antenna to the surrounding tissue.
[0020]
20. DRIVER according to claim 19, characterized by the fact that the antenna coupling contacts include two to eight pairs of antenna coupling.
[0021]
21. CONDUCTOR, according to claim 19, characterized by the fact that the antenna coupling contacts are located close, in relation to the electrodes, in the enclosure.
[0022]
22. DRIVER, according to claim 19, characterized by the fact that each of the antenna coupling contacts has a longitudinal length between 1.0 mm and 6.0 mm and a width between 1.0 mm and 2.5 mm.
[0023]
23. DRIVER, according to claim 19, characterized by the fact that the antenna coupling contacts are spaced between 30 mm and 80 mm.
[0024]
24. DRIVER, according to claim 1, characterized by the fact that the first antenna is built as a conductive trace contained in one of the circuits.
[0025]
25. CONDUCTOR, according to claim 1, characterized by the fact that the first antenna is manufactured as a conductive wire connected to one of the circuits.
[0026]
26. DRIVER, according to claim 1, characterized by the fact that the circuits are flexible circuits.
[0027]
27. DRIVER, according to claim 26, characterized by the fact that the flexible circuits are capable of undergoing a radius of curvature of less than 0.5 mm.
[0028]
28. CONDUCTOR, according to claim 26, characterized by the fact that the flexible circuits are placed in a proximal position, in relation to the electrodes, in the enclosure.
[0029]
29. DRIVER according to claim 26, characterized by the fact that the flexible circuits include a waveform conditioning circuit (209).
[0030]
30. CONDUCTOR, according to claim 29, characterized by the fact that the housing still houses the antenna coupling contacts (222) defined in claim 19, in which the antenna coupling contacts (222) are connected by conductive wires (210) to the antenna (208) and the waveform conditioning circuit (209), wherein the waveform conditioning circuit uses input energy to provide a stimulation waveform to the electrodes for excitation of the nervous tissue.
[0031]
31. DRIVER, according to claim 30, characterized by the fact that the waveform conditioning circuit (209) includes diodes, resistors and / or capacitors.
[0032]
32. DRIVER, according to claim 30, characterized by the fact that the waveform conditioning circuit (209) comprises load balancing microelectronics to prevent electrode corrosion.
[0033]
33. DRIVER according to claim 29, characterized by the fact that the waveform conditioning circuit (209) comprises isolation circuits.
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同族专利:
公开号 | 公开日
IL228485D0|2013-12-31|
US20190247660A1|2019-08-15|
CN110013606A|2019-07-16|
EP3586908A1|2020-01-01|
JP6671843B2|2020-03-25|
CA2831138A1|2012-10-11|
US10953228B2|2021-03-23|
EP2694154A4|2014-12-10|
JP2018110892A|2018-07-19|
AU2012240239B2|2017-01-05|
EP2694154B1|2019-07-17|
JP6953332B2|2021-10-27|
WO2012138782A1|2012-10-11|
EP2694154A1|2014-02-12|
IL228485A|2018-06-28|
AU2012240239A1|2013-10-10|
US20210275813A1|2021-09-09|
JP2014514069A|2014-06-19|
CN103492022A|2014-01-01|
IL259882D0|2018-07-31|
MX346885B|2017-04-04|
MX2013010940A|2014-02-28|
BR112013025521A2|2019-09-24|
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法律状态:
2019-10-01| B08F| Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]|
2019-12-10| B25C| Requirement related to requested transfer of rights|Owner name: STIMWAVE TECHNOLOGIES, INCORPORATED (US) Free format text: A FIM DE ATENDER A TRANSFERENCIA, REQUERIDA ATRAVES DA PETICAO NO 870170029572 DE 04/05/2017, E NECESSARIO APRESENTAR DOCUMENTO NOTARIZADO E COM APOSTILAMENTO OU LEGALIZACAO CONSULAR, TRADUCAO JURAMENTADA DO MESMO, ALEM DA GUIA DE CUMPRIMENTO DE EXIGENCIA. |
2020-03-10| B25A| Requested transfer of rights approved|Owner name: MICRON DEVICES LLC (US) |
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优先权:
申请号 | 申请日 | 专利标题
US201161471496P| true| 2011-04-04|2011-04-04|
US61/471,496|2011-04-04|
PCT/US2012/032200|WO2012138782A1|2011-04-04|2012-04-04|Implantable lead|
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