Systems for implanting a neuromodulation lead using a cannula

Abstract

System and devices for implanting a neuromodulation lead using a cannula are provided. The cannula includes a body extending from a first end to a second end and a bore extending through the body from the first end to the second end. The body includes an outer surface and an inner surface defined by the bore. The cannula includes one or more channels recessed on the inner surface and / or one or more perforations extending through the body.

Description

SYSTEMS FOR IMPLANTING A NEUROMODULATION LEAD USING A CANNULACROSS-RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 676,210, filed July 26, 2024, which is incorporated herein by reference in its entirety.BACKGROUND

[0002] The present disclosure is generally directed to lead implantation, and relates more particularly to using a cannula with one or more internal channels or flutes and / or one or more perforations to implant the lead.

[0003] Medical devices may be external or implanted, and may be used to deliver electrical stimulation therapy to various tissue sites of a patient to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson’s disease, other movement disorders, epilepsy, urinary or fecal incontinence, etc. A medical device delivers electrical stimulation therapy via one or more leads that include electrodes located proximate to target locations associated with the brain, the spinal cord, pelvic nerves, peripheral nerves, or the gastrointestinal tract of a patient. Electrical stimulation is used in different therapeutic applications, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, or peripheral nerve field stimulation (PNFS).BRIEF SUMMARY

[0004] Example aspects of the present disclosure include:

[0005] A system for inserting a lead for neuromodulation according to at least one embodiment of the present disclosure comprises a lead having one or more electrodes; a sensor for measuring a value of the one or more electrodes; a cannula configured to receive the lead, the cannula having a body extending from a first end to a second end and a bore extending through the body from the first end to the second end, the body having an outer surface and an inner surface defined by the bore, the cannula having one or more channels recessed on the inner surface; at least one processor; and at least one memory storing instructions for execution by the at least one processor that, when executed, cause the at least one processor to: receive a value measurement from the sensor for each of the one or more electrodes, and generate a notification if the value measurement for one of the one or more electrodes is less than a predetermined threshold.

[0006] Any of the aspects herein, wherein the cannula includes one or more perforations extending through the body and positioned at least near the second end.

[0007] Any of the aspects herein, wherein the one or more perforations comprises a plurality of perforations.

[0008] Any of the aspects herein, wherein the plurality of perforations is positioned along a length of the body.

[0009] Any of the aspects herein, wherein a first perforation of the plurality of perforations has a shape and size different than a second perforation of the plurality of perforations.

[0010] Any of the aspects herein, wherein the one or more channels extend from the first end to the second end.

[0011] Any of the aspects herein, wherein the one or more channels are helical.

[0012] Any of the aspects herein, wherein the sensor comprises an impedance meter and the value comprises an impedance.

[0013] A system for inserting a lead for neuromodulation according to at least one embodiment of the present disclosure comprises a lead having one or more electrodes; a cannula configured to receive the lead, the cannula having a body extending from a first end to a second end and a bore extending through the body from the first end to the second end, the body having an outer surface and an inner surface defined by the bore, the cannula having one or more perforations extending through the body and positioned at least near the second end; at least one processor; and at least one memory storing instructions for execution by the at least one processor that, when executed, cause the at least one processor to: receive an impedance measurement for each of the one or more electrodes, and generate a notification if the impedance measurement for one of the one or more electrodes is less than a predetermined threshold.

[0014] Any of the aspects herein, further comprising: a sensor for measuring the impedance of the one or more electrodes.

[0015] Any of the aspects herein, wherein the sensor comprises an impedance meter.

[0016] Any of the aspects herein, wherein the one or more perforations comprises a plurality of perforations.

[0017] Any of the aspects herein, wherein the plurality of perforations is positioned along a length of the body.

[0018] Any of the aspects herein, wherein the cannula includes one or more channels disposed on the inner surface.

[0019] Any of the aspects herein, wherein the one or more channels extend from the first end to the second end.

[0020] Any of the aspects herein, wherein the one or more channels are helical.

[0021] A cannula configured to receive a neuromodulation lead according to at least one embodiment of the present disclosure comprises a body extending a length from a first end to a second end; a bore extending through the body from the first end to the second end, the body having an outer surface and an inner surface defined by the bore; one or more channels recessed on the inner surface; and one or more perforations positioned near at least the second end and extending through the body from the outer surface to the inner surface.

[0022] Any of the aspects herein, wherein the one or more channels extend from the first end to the second end.

[0023] Any of the aspects herein, wherein the one or more channels are helical.

[0024] Any of the aspects herein, wherein the one or more perforations comprises a plurality of perforations.

[0025] Any aspect in combination with any one or more other aspects.

[0026] Any one or more of the features disclosed herein.

[0027] Any one or more of the features as substantially disclosed herein.

[0028] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0029] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments .

[0030] Use of any one or more of the aspects or features as disclosed herein.

[0031] It is to be appreciated that any feature described herein can be claimed in combination with any other feature(s) as described herein, regardless of whether the features come from the same described embodiment.

[0032] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

[0033] The phrases “at least one”, “one or more”, and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and / or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressionsrefers to an element, such as X, Y, and Z, or class of elements, such as XI -Xn, Yl-Ym, and Zl-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., XI and X2) as well as a combination of elements selected from two or more classes (e.g., Y1 and Zo).

[0034] The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.

[0035] The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.

[0036] Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0037] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.

[0038] Fig. 1A is a block diagram of a system according to at least one embodiment of the present disclosure;

[0039] Fig. IB is a block diagram of a system according to at least one embodiment of the present disclosure;

[0040] Fig. 2 is an isometric view of a cannula according to at least one embodiment of the present disclosure;

[0041] Fig. 3 is an isometric view of a cannula according to at least one embodiment of the present disclosure;

[0042] Fig. 4 is an side, cross-sectional view of a cannula according to at least one embodiment of the present disclosure; and

[0043] Fig. 5 is an isometric, cross-sectional view of a cannula according to at least one embodiment of the present disclosure;

[0044] Fig. 6 is an isometric, cross-sectional view of a cannula according to at least one embodiment of the present disclosure; and

[0045] Fig. 7 is a flowchart according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0046] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example or embodiment, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, and / or may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the disclosed techniques according to different embodiments of the present disclosure). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a computing device and / or a medical device.

[0047] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, functions may be implemented using machine learning models, neural networks, artificial neural networks, or combinations thereof (alone or in combination with instructions). Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0048] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; IntelCeleron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple Al l, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors), graphics processing units (e.g., Nvidia GeForce RTX 2000-series processors, Nvidia GeForce RTX 3000-series processors, AMD Radeon RX 5000-series processors, AMD Radeon RX 6000-series processors, or any other graphics processing units), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0049] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one or more aspects thereof. Unless explicitly stated otherwise, the use or listing of one or more examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure.

[0050] The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.

[0051] During an implantation procedure of one or more leads of a neuromodulation system, an impedance of the system is tested to ensure connectivity between the one or more leads and the target tissue and to check an integrity of the lead. In some instances, high impedance readings may occur immediately after implantation of the one or more leads. Such high impedance readings may result in programming difficulties intraoperatively for, for example, DBS. Such high impedance readings may be due to air being pushed through the cannula as the lead is inserted through the cannula and the air is unable to escape except through where the lead is implanted. Conventionally,to offset such high impedance readings, the lead may be replaced, a different cannula may be used to reimplant the lead, and / or the impedance may be retested, which are time consuming processes.

[0052] According to at least one embodiment of the present disclosure, a cannula having one or more internal flutes and / or channels and / or one or more perforations is provided. The one or more internal flues and / or one or more perforations may enable air to escape out of the cannula during insertion rather than causing bubbles at or near the electrode-tissue interface. Thus, the cannula may reduce implantation time as the cannula may reduce or eliminate high impedance readings resulting from air trapped at the electrode-tissue interface.

[0053] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) reducing or eliminating high impedance readings after implantation of one or more leads, (2) reducing operating time for lead implantation, and (3) increasing patient and medical team safety.

[0054] Turning first to Figs. 1A-1B, aspects of a conceptual diagram illustrating a neuromodulation system 100 are shown in accordance with embodiments of the present disclosure. The conceptual diagram depicts an implantable medical device (IMD) 106 configured to deliver neuromodulation therapy to a patient 115 such as, for example, DBS. It will be appreciated that in other embodiments, the neuromodulation therapy may be, for example, SCS, pelvic stimulation, gastric stimulation, or PNFS. In some examples, the neuromodulation therapy may be closed-loop in the sense that the IMD 106, as one example, may adjust, increase, or decrease the magnitude of one or more parameters of the neuromodulation therapy in response to feedback such as changes in patient activity or movement, a severity of one or more symptoms of a disease of the patient, a presence of one or more side effects due to the neuromodulation therapy, and / or one or more sensed signals of the patient. In one example, the neuromodulation system 100 comprises a bi-directional DBS system with capabilities to both deliver stimulation, sense intrinsic neuronal signals, and sense neural signals that are evoked in response to delivery of stimulation. The neuromodulation system 100 comprises the IMD 106, a lead 114A with a set of electrodes 116 (shown in Fig. IB), and a lead 114B with a set of electrodes 118.

[0055] The electrodes 116, 118 of the leads 114A, 114B may be positioned to deliver electrical stimulation to a tissue site within a brain 120 of the patient 115, such as a deep brain site under the dura mater of the brain 120 of the patient 115. The leads 114A, 114B may be installed during an implantation procedure in which the leads 114A, 114B are inserted into the brain 120 using one or more cannulas 200, shown and discussed in detail in Figs. 2-6. The IMD 106 may be implanted within a subcutaneous pocket above the clavicle, or, alternatively, on or within the cranium or at anyother suitable site within the patient 115. Generally, the IMD 106 is constructed of a biocompatible material that resists corrosion and degradation from bodily fluids. The IMD 106 may comprise a hermetic housing to substantially enclose components, such as a processor, therapy module, and memory. In some examples, delivery of stimulation to one or more regions of the brain 120, such as the subthalamic nucleus (STN), globus pallidus or thalamus, ventralus intermediate (VIM), anterior nucleus (ANT), ventral internal capsule / ventral striatum (VC VS), corti co-basal ganglia- thalamocortical circuit, or anterior insular cortex (AIC), may be an effective treatment to manage disorders, such as Parkinson’s disease.

[0056] Some or all of the electrodes 116, 118 also may be positioned to sense neurological brain signals within the brain 120 of the patient 115. In some examples, some of the electrodes 116, 118 may be configured to sense neurological brain signals and others of the electrodes 116, 118 may be configured to deliver electrical stimulation to the brain 120. In other examples, all of the electrodes 116, 118 are configured to both sense neurological brain signals and deliver electrical stimulation to the brain 120. In some examples, unipolar stimulation may be possible where one electrode is on the housing of the IMD 106. Although the IMD 106 is described as delivering electrical stimulation therapy to the brain 120, the IMD 106 may be configured to direct electrical stimulation to other anatomical regions of the patient 115. Further, an IMD may provide other electrical stimulation such as spinal cord stimulation to treat a movement disorder.

[0057] The IMD 106 includes a therapy module (e.g., which may include processing circuitry or other electrical circuitry configured to perform the functions attributed to the IMD 106) that includes stimulation generation circuitry configured to generate and deliver electrical stimulation therapy to the patient 115 via a subset of the electrodes 116, 118 of the leads 114A and 114B, respectively. The subset of the electrodes 116, 118 that are used to deliver electrical stimulation to the patient 115, and, in some cases, the polarity of the subset of the electrodes 116, 118, may be referred to as a stimulation electrode combination. As described in further detail below, the stimulation electrode combination can be selected for a particular patient and target tissue site (e.g., selected based on the patient condition). The group of the electrodes 116, 118 includes at least one electrode and can include a plurality of electrodes. In some examples, the plurality of the electrodes 116 and / or 118 may have a complex electrode geometry such that two or more electrodes are located at different positions around the perimeter of the respective lead.

[0058] Therapeutic electrical stimulation generated by the IMD 106 may be configured to manage a variety of disorders and conditions. In some examples, the stimulation generation circuitry of the IMD 106 is configured to generate and deliver therapeutic electrical stimulation pulses to the patient115 via electrodes of a selected stimulation electrode combination. However, in other examples, the stimulation generation circuitry of the IMD 106 may be configured to generate and deliver a continuous wave signal, e.g., a sine wave or triangle wave. In either case, stimulation generation circuitry within the IMD 106 may generate the electrical stimulation therapy for DBS according to a selected therapy program. In examples in which the IMD 106 delivers therapeutic electrical stimulation in the form of stimulation pulses, a therapy program may include a set of therapy parameter values (e.g., parameters), such as a stimulation electrode combination for delivering stimulation to the patient 115, pulse frequency, pulse width, and a current or voltage amplitude of the pulses. As previously indicated, the electrode combination may indicate the specific electrodes 116, 118 that are selected to deliver therapeutic stimulation signals to tissue of the patient 115 and the respective polarities of the selected electrodes.

[0059] Turning to Fig. IB, a block diagram of a system 101 according to at least one embodiment of the present disclosure is shown. The system 101 may be used with the neuromodulation system100 or components thereof, and / or may carry out one or more other aspects of one or more of the methods disclosed herein. The system 101 may also be used during implantation of the leads 114A, 114B (or any lead) with the cannula 200 to measure and / or monitor impedance of the leads 114A,114B after implantation of the leads 114A, 114B.

[0060] The system 101 comprises the IMD 106, a computing device 102, a database 111, and / or a cloud or other cloud network 140. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system 101. For example, the system 101 may not include one or more components of the computing device 102, one or more components of the IMD 106, the database 111, and / or the cloud network 140. While the computing device 102 of the system101 is illustrated as being in communication with the IMD 106, it is to be understood that the computing device 102 may be disposed as a sub-component within the IMD 106, or may alternatively be an external device that communicates with the IMD 106 using, for example, a communication interface 108, or through the cloud 140 or other network. In some embodiments, the IMD 106 may include any one or more components of the system 101 including, but not limited to, the computing device 102, the processor 104, the memory 105, the communication interface 108, the database 111, combinations thereof, and the like.

[0061] The IMD 106 may comprise the leads 114A, 114B, the electrodes 116, 118, and the sensor(s) 112. It will be appreciated that the sensor(s) 112 may be a separate component from the IMD 106. As previously described, the leads 114 and the electrodes 116, 118 may be configured to apply the current to an anatomical element (e.g., the brain, the spinal cord, one or more nerves, etc.).The IMD 106 may communicate with the computing device 102 to receive instructions such as instructions for applying a current to the anatomical element. The IMD 106 may also provide data (such as data received from or measured by the electrodes 116, 118), which may be used to calibrate and / or control the IMD 106.

[0062] The sensor(s) 112 may be used to measure an impedance of the lead(s) 114 A, 114B (or any lead) during, for example, an implantation procedure. In some embodiments, the sensor(s) 112 may be an impedance meter. The impedance meter may be configured to measure impedance at each electrode of the electrodes 116, 118 during and / or after implantation of the lead 114A, 114B. In other words, the impedance meter may be configured to measure impedance at one electrode at a time. As will be described in detail below, the sensor(s) 112 may be used to measure the impedance of the lead(s) 114A, 114B and may be used to cause a processor such as the processor 104 to generate a notification when the impedance is less than a predetermined impedance threshold.

[0063] The cannula 200 may be used during, for example, implantation of the lead(s) 114A, 114B. As will be described in detail in Figs. 2-6, the cannula 200 may include one or more channels or flutes and / or one or more perforations to enable air to escape the cannula 200 during insertion of the lead(s) 114A, 114B through the cannula 200. The cannula 200 may have any number, size, and / or pattern of channels, flutes, and / or perforations. The cannula 200 may also have any internal diameter size and / or any external diameter size.

[0064] The computing device 102 comprises the processor 104, a memory 105, a communication interface 108, and a user interface 110. Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device 102.

[0065] The processor 104 of the computing device 102 may be any processor described herein or any similar processor. The processor 104 may be configured to execute instructions stored in the memory 105, which instructions may cause the processor 104 to carry out one or more computing steps utilizing or based on data received from the device 102, the database 111, and / or the cloud network 140.

[0066] The memory 105 may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory for storing computer- readable data and / or instructions. The memory 105 may store information or data useful for completing, for example, one or more steps of the method 700 described herein, or of any other methods. The memory 105 may store, for example, instructions and / or machine learning models (e.g., neural networks) that support one or more functions of the device 102. For instance, thememory 105 may store content (e.g., instructions and / or machine learning models) that, when executed by the processor 104, enable sensor processing 122 and / or notification generation 124.

[0067] The sensor processing 122 enables the processor 104 to process sensor data received from, for example, a sensor such as the sensor 112. The sensor data may be processed to obtain, for example, an impedance value of one or more electrodes of the electrodes 116, 118. Such information may be used to determine if the lead(s) 114 A, 114B have adequate connectivity with the target tissue.

[0068] The notification generation 124 enables the processor 104 to generate a notification when a value such as the impedance value is below a predetermined threshold. It will be appreciated that in some embodiments, the notification may be generated when the impedance value is above the predetermined threshold. The notification may be an audible and / or a visual notification (which may be displayed on, for example, the user interface 110).

[0069] Content stored in the memory 105, if provided as in instruction, may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines. Alternatively or additionally, the memory 105 may store other types of content or data (e.g., machine learning models, artificial neural networks, deep neural networks, etc.) that can be processed by the processor 104 to carry out the various method and features described herein. For example, the memory 105 may store one or more parameters of the IMD 106 and / or one or more predetermined thresholds which may be used to, for example, determine which sets of data to use to adjust the one or more parameters. Thus, although various contents of memory 105 may be described as instructions, it should be appreciated that functionality described herein can be achieved through use of instructions, algorithms, and / or machine learning models. The data, algorithms, and / or instructions may cause the processor 104 to manipulate data stored in the memory 105 and / or received from or via the device 102, the database 111, and / or the cloud network 140.

[0070] The computing device 102 may also comprise a communication interface 108. The communication interface 108 may be used for receiving data (for example, data from the device 102) or other information from an external source (such as the device 102, the database 111, the cloud network 140, and / or any other system or component not part of the system 101), and / or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device 102, the device 102, the database 111, the cloud network 140, and / or any other system or component not part of the system 101). The communication interface 108 may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and / or one or more wireless transceivers or interfaces (configured, for example, to transmit and / or receive informationvia one or more wireless communication protocols such as 602.11a / b / g / n, Bluetooth, NFC, ZigBee, and so forth). In some embodiments, the communication interface 108 may be useful for enabling the computing device 102 to communicate with one or more other processors 104 or computing devices 102, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.

[0071] The computing device 102 may also comprise one or more user interfaces 110. The user interface 110 may be or comprise a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and / or any other device for receiving information from a user and / or for providing information to a user. The user interface 110 may be used, for example, to receive a user selection or other user input regarding any step of any method described herein. Notwithstanding the foregoing, any required input for any step of any method described herein may be generated automatically by the system 101 (e.g., by the processor 104 or another component of the system 101) or received by the system 101 from a source external to the system 101. In some embodiments, the user interface 110 may be useful to allow a surgeon or other user to modify instructions to be executed by the processor 104 according to one or more embodiments of the present disclosure, and / or to modify or adjust a setting of other information displayed on the user interface 110 or corresponding thereto.

[0072] Although the user interface 110 is shown as part of the computing device 102, in some embodiments, the computing device 102 may utilize a user interface 110 that is housed separately from one or more remaining components of the computing device 102. In some embodiments, the user interface 110 may be located proximate one or more other components of the computing device 102, while in other embodiments, the user interface 110 may be located remotely from one or more other components of the computing device 102.

[0073] The database 111 may store information such as one or more predetermined values. The database 111 may be configured to provide any such information to the computing device 102 or to any other device of the system 101 or external to the system 101, whether directly or via the cloud network 140.

[0074] The cloud network 140 may be or represent the Internet or any other wide area network. The computing device 102 may be connected to the cloud network 140 via the communication interface 108, using a wired connection, a wireless connection, or both. In some embodiments, the computing device 102 may communicate with the database 111 and / or an external device (e.g., a computing device) via the cloud network 140.

[0075] The system 101 or similar systems may be used, for example, to carry out one or more aspects of the method 700 described herein. The system 101 or similar systems may also be used for other purposes.

[0076] Turning to Figs. 2-6, example embodiments of the cannula 200 according to the present disclosure are provided. The cannula 200 includes a body 202 extending a length L from a first end 204 to a second end 206. The cannula 200 also includes a bore 208 extending through the body 202 from the first end 204 to the second end 206. The body 202 has an outer surface 210 and an inner surface 212 defined by the bore 208.

[0077] In the illustrated embodiment, the cannula 200 includes one or more perforations 214 positioned along the length L of the cannula 200 from the first end 204 to the second end 206. It will be appreciated that in other embodiments, the one or more perforations 214 may be positioned at any portion of the cannula 200. For example, as shown in Fig. 4, the one or more perforations 214 are positioned near the first end 204 of the cannula 200. In other embodiments, the one or more perforations 214 may be spaced near or at the second end 206, the first end 204, a center portion, or anywhere on the cannula 200.

[0078] The one or more perforations 214 may include a plurality of perforations. It will be appreciated that in other embodiments the one or more perforations 214 may include one perforation 214, two perforations 214, or more than two perforations 214. The one or more perforations 214 are also shown spaced around a perimeter of the cannula 200 and in rows at equal distances from each other. In other instances, the one or more perforations 214 may be spaced in any pattern or distance from each other. Similarly, each perforation 214 may be the same size and shape, as shown in the illustrated embodiment, or may be different sizes and shapes in other embodiments. For example, as shown in Fig. 2, the one or more perforations 214 may be circular; as shown in Fig. 3, the one or more perforations 214 may be rectangular; and / or as shown in Fig. 4, the one or more perforations 214 may be different rectangular sizes. It will be appreciated that the one or more perforations 214 can be any combination of sizes and / or shapes such as, for example, oval, square, triangular, star, or the like. The one or more perforations 214 may be sized, shaped, and positioned so as to allow air to escape the cannula 200 while also preventing tissue from entering the cannula 200.

[0079] Turning to Figs. 5 and 6, a first cross-sectional isometric view and a second cross-sectional isometric view of the cannula 200 with one or more channels 220 are respectively shown. The one or more channels 220 may be recessed on the inner surface 212. In some embodiments, the one or more channels 220 extend from the first end 204 to the second end 206 of the cannula 200. In other embodiments, the one or more channels 220 extend a partial length or distance between the first end204 and the second end 206. As shown in Fig. 5, the one or more channels 220 may be parallel to a longitudinal axis 222 of the cannula 200. In other words, the one or more channels 220 may be straight. In other embodiments, the one or more channels 220 may be at an angle to the longitudinal axis 222, as shown in Fig. 6. In still other embodiments, the one or more channels 220 may form any pattern or shape or combinations thereof and may be, for example, helical.

[0080] In the illustrated embodiments each channel of the one or more channels 220 have the same width and same recessed depth. In other embodiments, each channel of the one or more channels 220 may have different widths and / or different recessed depths. It will be appreciated that in some embodiments, the recessed depth may be determined based on a wall thickness of the cannula 200. For example, the recessed depth may be optimized to minimize impact to an outer diameter of the cannula 200 while maintaining the same wall thickness of the cannula 200 without impact to an integrity of the cannula 200. Further, the cannula 200 may have an inner diameter sized to enable the insertion of leads and / or tools into the cannula 200.

[0081] The cannula 200 may be formed of any material such as, for example, a metal, a metal alloy, plastic, or the like. Examples of metals may include, for example, stainless steels, titanium and titanium alloys, MP35N alloy, and other medical grade corrosion resistant alloys. Examples of plastic materials are, for example, polyamide, polyimide, fluoropolymers such as PTFE, polyurethanes, polycarbonates, and their variations. In some embodiments, the cannula 200 may be formed with a secondary polymeric material such as silicone, parylene or a fluoropolymer as a coating. The cannula 200 may be incorporated with pharmaceuticals such as antimicrobial or antithrombotic agents, as a material constituent or a coating or a combination. The cannula 200 may be manufactured using techniques such as extrusion, molding, patterning using mechanical or laser based techniques. The cannula 200 may also have any length, diameter, or size. In some instances, a user such as a surgeon or other medical provider may have a set of cannulas 200 of various sizes, lengths, and / or diameters.

[0082] It will be appreciated that the cannula 200 may include any number and / or combination of perforations 214 and / or channels 220. For example, the cannula 200 may include two or more channels 220 extending the length of the cannula 200 and a plurality of perforations 214 positioned near the first end 204 of the cannula 200. In any combination of perforations 214 and / or channels 220, it will be appreciated that the perforations 214 and / or the channels 220 enable air to beneficially exit the cannula 200 away from the target electrode-tissue interface. In other words, air can escape the cannula 200 at the one or more perforations 214 or may travel through the one or more channels 220 from the first end 204 near the target electrode-tissue interface to the second end 206 and awayfrom the target electrode-tissue interface. Thus, the cannula 200 helps prevent air from forming or becoming trapped at the target electrode-tissue interface.

[0083] Fig. 7 depicts a method 700 that may be used, for example, for an implantation procedure to implant one or more leads such as the leads 114 A, 114B.

[0084] The method 700 (and / or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor(s) 104 of the computing device 102 described above. A processor other than any processor described herein may also be used to execute the method 700. The at least one processor may perform the method 700 by executing elements stored in a memory such as the memory 105. The elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 700. One or more portions of a method 700 may be performed by the processor executing any of the contents of memory, such as a sensor processing 122 and / or a notification generation 124.

[0085] The method 700 comprises inserting a cannula (step 704). The cannula may be the same as or similar to the cannula 200. The cannula includes a body such as the body 202 extending a length L from a first end such as the first end 204 to a second end such as the second end 206. The cannula also includes a bore such as the bore 208 extending through the body from the first end to the second end. The body has an outer surface such as the outer surface 210 and an inner surface such as the inner surface 212 defined by the bore. The cannula may include one or more perforations such as the one or more perforations 214, one or more channels such as the one or more channels 220, or a combination thereof.

[0086] The method 700 also comprises inserting a lead through the cannula (step 708). The lead may be the same as or similar to the lead 114A, 114B and may include one or more electrodes such as the one or more electrodes 116, 118. During implantation, the lead is inserted through the cannula to the target electrode-tissue interface. With conventional cannulas, air may become trapped at the target electrode-tissue interface and may lead to improper contact between the electrode-tissue interface due to the air. Such improper contact may lead to time intensive troubleshooting procedures such as replacing the lead. Thus, the cannula as provided with one or more perforations and / or one or more channels may enable the air to beneficially escape or exit from the cannula at a location or distance away from the target electrode-tissue interface.

[0087] The method 700 also comprises receiving sensor data (step 712). The sensor data may be received from a sensor such as the sensor 112. The sensor 112 may be a component of an IMD such as the IMD 106 and / or a computing device such as the computing device 102. In other embodiments,the sensor may be a standalone component. The sensor may be, for example, an impedance meter. The sensor may be used to measure impedance at each electrode of the one or more electrodes to determine a quality of the connection between the electrodes and the target tissue.

[0088] The method 700 also comprises processing the sensor data (step 716). The sensor data may be received at, for example, the step 712 described above from the sensor. The sensor data may be processed by a processor such as the processor 104 inputting the sensor data into a sensor processing such as the sensor processing 122. The sensor processing may process the sensor data and output one or more values such as, for example, impedance value(s).

[0089] The method 700 also comprises generating a notification (step 720). The notification may be generated based on instructions from the processor. The processor may, for example, input the impedance values obtained from the sensor data (processed in, for example, the step 716 described above) into a notification generation such as the notification generation 124. The notification generation may generate instructions for generating a notification when the impedance values are below a predetermined threshold. The predetermined threshold may be, for example, between about 250 ohms and about 8,000 ohms. It will be appreciated that in other embodiments, the predetermined threshold may be less than 250 ohms or greater than 8,000 ohms. Such predetermined threshold indicates that there is a proper connection between electrodes of the lead and the target tissue. If the impedance value is below the predetermined threshold, then this indicates that there is not a proper connection between the electrodes and the target tissue. In other embodiments, it will be appreciated that the notification may be generated when the impedance values are greater than a predetermined threshold.

[0090] The present disclosure encompasses embodiments of the method 700 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0091] As noted above, the present disclosure encompasses methods with fewer than all of the steps identified in Fig. 7 (and the corresponding description of the method 700 as well as methods that include additional steps beyond those identified in Fig. 7 (and the corresponding description of the method 700). The present disclosure also encompasses methods that comprise one or more steps from one method described herein, and one or more steps from another method described herein. Any correlation described herein may be or comprise a registration or any other correlation.

[0092] The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of streamliningthe disclosure. The features of the aspects, embodiments, and / or configurations of the disclosure may be combined in alternate aspects, embodiments, and / or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects he in less than all features of a single foregoing disclosed aspect, embodiment, and / or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0093] Moreover, though the foregoing has included description of one or more aspects, embodiments, and / or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and / or configurations to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0094] A set of example statements is provided below:

[0095] Statement 1 : A system for inserting a lead for neuromodulation, the system comprising: a lead having one or more electrodes; a sensor for measuring a value of the one or more electrodes; a cannula configured to receive the lead, the cannula having a body extending from a first end to a second end and a bore extending through the body from the first end to the second end, the body having an outer surface and an inner surface defined by the bore, the cannula having one or more channels recessed on the inner surface; at least one processor; and at least one memory storing instructions for execution by the at least one processor that, when executed, cause the at least one processor to: receive a value measurement from the sensor for each of the one or more electrodes, and generate a notification if the value measurement for one of the one or more electrodes is less than a predetermined threshold.

[0096] Statement 2: The system of Statement 1, wherein the cannula includes one or more perforations extending through the body and positioned at least near the second end.

[0097] Statement 3: The system of Statement 2, wherein the one or more perforations comprises a plurality of perforations.

[0098] Statement 4: The system of Statement 3, wherein the plurality of perforations is positioned along a length of the body.

[0099] Statement 5: The system of Statement 3, wherein a first perforation of the plurality of perforations has a shape and size different than a second perforation of the plurality of perforations.

[0100] Statement 6: The system of any of Statements 1-5, wherein the one or more channels extend from the first end to the second end.

[0101] Statement 7: The system of any of Statements 1-6, wherein the one or more channels are helical.

[0102] Statement 8: The system of any of Statements 1-7, wherein the sensor comprises an impedance meter and the value comprises an impedance.

[0103] Statement 9: A system for inserting a lead for neuromodulation, the system comprising: a lead having one or more electrodes; a cannula configured to receive the lead, the cannula having a body extending from a first end to a second end and a bore extending through the body from the first end to the second end, the body having an outer surface and an inner surface defined by the bore, the cannula having one or more perforations extending through the body and positioned at least near the second end; at least one processor; and at least one memory storing instructions for execution by the at least one processor that, when executed, cause the at least one processor to: receive an impedance measurement for each of the one or more electrodes, and generate a notification if the impedance measurement for one of the one or more electrodes is less than a predetermined threshold.

[0104] Statement 10: The system of Statement 9, further comprising: a sensor for measuring the impedance of the one or more electrodes.

[0105] Statement 11 : The system of Statement 10, wherein the sensor comprises an impedance meter.

[0106] Statement 12: The system of any of Statements 9-11, wherein the one or more perforations comprises a plurality of perforations.

[0107] Statement 13: The system of Statement 12, wherein the plurality of perforations is positioned along a length of the body.

[0108] Statement 14: The system of any of Statements 9-13, wherein the cannula includes one or more channels disposed on the inner surface.

[0109] Statement 15: The cannula of Statement 14, wherein the one or more channels extend from the first end to the second end.

[0110] Statement 16: The cannula of Statement 15, wherein the one or more channels are helical.

[0111] Statement 17: A cannula configured to receive a neuromodulation lead, the cannula comprising: a body extending a length from a first end to a second end; a bore extending through the body from the first end to the second end, the body having an outer surface and an inner surface defined by the bore; one or more channels recessed on the inner surface; and one or more perforations positioned near at least the second end and extending through the body from the outer surface to the inner surface.

[0112] Statement 18: The cannula of Statement 17, wherein the one or more channels extend from the first end to the second end.

[0113] Statement 19: The cannula of Statement 18, wherein the one or more channels are helical.

[0114] Statement 20: The cannula of any of Statements 17-19, wherein the one or more perforations comprises a plurality of perforations.

Claims

CLAIMSWhat is claimed is:

1. A system (100) for inserting a lead (114) for neuromodulation, the system comprising: a lead (114) having one or more electrodes (116); a sensor (112) for measuring a value of the one or more electrodes; a cannula (200) configured to receive the lead, the cannula having a body (202) extending from a first end (204) to a second end (206) and a bore (208) extending through the body from the first end to the second end, the body having an outer surface (210) and an inner surface (212) defined by the bore, the cannula having one or more channels (220) recessed on the inner surface; at least one processor (104); and at least one memory (104) storing instructions for execution by the at least one processor that, when executed, cause the at least one processor to: receive a value measurement from the sensor for each of the one or more electrodes, and generate a notification if the value measurement for one of the one or more electrodes is less than a predetermined threshold.

2. The system of claim 1, wherein the cannula includes one or more perforations (214) extending through the body and positioned at least near the second end.

3. The system of claim 2, wherein the one or more perforations comprises a plurality of perforations.

4. The system of claim 3, wherein the plurality of perforations is positioned along a length of the body.

5. The system of claim 3, wherein a first perforation of the plurality of perforations has a shape and size different than a second perforation of the plurality of perforations.

6. The system of any of claims 1-5, wherein the one or more channels extend from the first end to the second end.

7. The system of any of claims 1-6, wherein the one or more channels are helical.

8. The system of any of claims 1-7, wherein the sensor comprises an impedance meter and the value comprises an impedance.

9. A cannula (200) configured to receive a neuromodulation lead (114), the cannula comprising: a body (202) extending a length from a first end (204) to a second end (206); a bore (208) extending through the body from the first end to the second end, the body having an outer surface (210) and an inner surface (212) defined by the bore; one or more channels (220) recessed on the inner surface; and one or more perforations (214) positioned near at least the second end and extending through the body from the outer surface to the inner surface.

10. The cannula of claim 9, wherein the one or more channels extend from the first end to the second end.

11. The cannula of claim 10, wherein the one or more channels are helical.

12. The cannula of any of claims 9-11, wherein the one or more perforations comprises a plurality of perforations.

13. The cannula of claim 12, wherein the plurality of perforations is positioned along a length of the body.

14. The cannula of claim 13, wherein a first perforation of the plurality of perforations has a shape and size different than a second perforation of the plurality of perforations.

15. The cannula of claim 13, wherein the plurality of perforations are a same shape and size.

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