Multimodal pain management system and method

Abstract

An infusion lead assembly according to a disclosed aspect includes a housing having a needle receptacle, a housing lumen, a pin receptacle and a housing conductive trace, a connector having a connector needle, an inner lumen, a metallic pin and a connector conductive trace, and an infusion lead body having an infusion lumen, an exit port, an inner wire and a tip electrode. The infusion lead assembly forms an electrical pathway for transmitting an electrical signal across the connector conductive trace, the metallic pin, the housing conductive trace, the inner wire and the tip electrode. The infusion lead assembly forms a fluid pathway for transmitting a fluid across the inner lumen, the connector needle, the infusion lumen and the exit port.

Description

Technical Field

[0005] , ,

[0001] The present disclosure generally relates to devices, systems, and methods for pain management (e.g., sports pain management, sensory pain management, etc.), vasodilation, and / or arteriovenous fistula (AVF) maturation.

Background Art

[0002] Peripheral nerve blocks can be used to reduce intraoperative and postoperative pain. To perform a nerve block, a local anesthetic is injected around the nerves distributed at the surgical site. The drawback of nerve blocks is that there is a limit to the time during which intraoperative pain can be reduced.

[0003] To address postoperative pain beyond the effective time of anesthetic injection, opioids are often prescribed. However, opioids are known to be highly toxic and may lead to a chain of social and health problems, including death.

[0004] This background is presented herein for the purpose of generally presenting the content of the disclosure. Unless otherwise stated herein, the matters described in this section are not prior art to the claims of this application and are not admitted to be prior art or suggestions of prior art by inclusion in this section.

Summary of the Invention

Means for Solving the Problems

[0005] According to certain aspects of the present disclosure, methods and systems for multimodal pain management are disclosed. An injection lead assembly according to the disclosed embodiment comprises a housing having a needle receptacle, a housing lumen, a pin receptacle, and a housing conductive trace; a connector having a connector needle, an internal lumen, a metal pin, and a connector conductive trace; and an injection lead body having an injection lumen, an outlet port, an internal wire, and a tip electrode. The injection lead assembly forms an electrical path for transmitting electrical signals across the connector conductive trace, the metal pin, the housing conductive trace, the internal wire, and the tip electrode, and the injection lead assembly forms a fluid path for transmitting fluid across the internal lumen, the connector needle, the injection lumen, and the outlet port.

[0006] The housing may comprise a first gasket forming a fluid seal with the needle receptacle and a second gasket forming a fluid seal with the pin receptacle. The housing may comprise a first gasket forming a fluid seal with the needle receptacle and a second gasket forming a fluid seal with the pin receptacle, and at least one of the first or second gasket may include an inline filter. The housing may comprise a first gasket forming a fluid seal with the needle receptacle and a second gasket forming a fluid seal with the pin receptacle, and at least one of the first or second gasket may include an inline filter, and the inline filter may include an antimicrobial material or an antimicrobial coating. The housing may comprise a housing connector and the connector may comprise a connector connector, and the housing connector may be molded to receive the connector connector. The housing may comprise a housing connector and the connector may comprise a connector connector, and the connector connector may be molded to receive the housing connector. The housing lumen may be configured to communicate with a drug pump, a connector needle connected to the drug pump via an infusion tube, an infusion lumen, and an outlet port. The drug pump may include a spring system comprising at least one spring, the compression of which causes fluid to be transmitted across the internal lumen, and the contraction of which causes a second fluid to be collected from an external container into the drug pump. The pin receptacle may include an electrical surface for conductivity with a pulse generator, a housing conductive trace, an internal wire, and a proximal electrode. It may also include a proximal electrode. It may also include a fastener. The connector conductive trace may be conductive with a pulse generator cable connected to the pulse generator. The housing may be configured to be positioned subcutaneously and may further include a subcutaneous injection port and a sealing gasket sealed to the subcutaneous injection port.

[0007] Other embodiments of the injection lead assembly disclosed herein include a receiver having a receiving antenna that wirelessly receives power from a transmitting component; a subcutaneous housing having a needle receptacle, a housing lumen, a pin receptacle, and a housing conductive trace; and an injection lead body having an injection lumen, an outlet port, an internal wire, and a tip electrode. The injection lead assembly may form an electrical path for transmitting electrical signals across the receiving antenna, the housing conductive trace, the internal wire, and the tip electrode, and the injection lead assembly may form a fluid path for transmitting fluid across the injection lumen and the outlet port.

[0008] Power may be supplied by a transmission module. The subcutaneous housing may include a subcutaneous injection port communicating with the injection lumen. Other methods for multimodal stimulation disclosed herein include receiving an electrical signal at a connector, sending the electrical signal to the tip electrode of the internal injection lead body via the connector conductive trace, connector metal pin, housing pin receptacle, housing conductive trace and internal wire of the injection lead body at a first time point, receiving a fluid at the connector, and sending the fluid to the outlet port of the injection lead body via the connector internal lumen, connector needle, housing needle receptacle, housing lumen and injection lumen of the injection lead body at a second time point.

[0009] The first and second time points may be approximately the same. An electrical signal or fluid may be received based on user input. At least one of the electrical signal or fluid may be received based on a pre-programmed setting. An electrical signal may be received by a wireless subcutaneous receiver, and a fluid may be received by a subcutaneous injection port. Pain management and at least one of the following may be performed by delivering fluid through the exit port at the second time point: pain management, vasodilation of at least one tissue, vein, or nerve, and arteriovenous fistula (AVF) maturation.

[0010] The above summary is not intended to describe any embodiment or example of the present disclosure. The accompanying drawings incorporated herein and constituting part thereof illustrate exemplary embodiments illustrating the spirit of the embodiments disclosed in conjunction with the description herein. These drawings illustrate various aspects of the disclosure, and similar structures, components, materials and / or elements in different drawings are appropriately denoted by similar reference numerals. Various combinations of structures, components and / or elements other than those specifically shown are possible and are understood to be within the scope of the disclosure.

[0011] The drawings illustrate exemplary embodiments of the present disclosure and, together with the detailed description, illustrate the intent of the present disclosure. The drawings are for illustrative purposes only of specific embodiments and do not limit the disclosure or the invention. [Brief explanation of the drawing]

[0012] [Figure 1] A schematic diagram showing a part of a multimodal system according to an exemplary embodiment of the present disclosure. [Figure 1A] A schematic diagram showing a drug pump used with the system of Figure 1, according to an exemplary embodiment of the present disclosure. [Figure 1B] A schematic diagram showing a pulse generator used with the system of Figure 1, according to an exemplary embodiment of the present disclosure. [Figure 1C] A schematic diagram showing a combined drug pump and pulse generator used with the system of Figure 1, according to an exemplary embodiment of the present disclosure. [Figure 1D] A schematic diagram showing another drug pump according to an exemplary embodiment of the present disclosure. [Figure 1E] A schematic diagram of the inside of the drug pump shown in Figure 1D, according to an exemplary embodiment of the present disclosure. [Figure 1F] A flowchart of the operation of the drug pump in Figure 1D, according to an exemplary embodiment of the present disclosure. [Figure 2] A schematic diagram showing a housing, adhesive patch, and connector according to an exemplary embodiment of the present disclosure. [Figure 2A] Schematic diagram showing another connector according to an exemplary embodiment of the present disclosure. [Figure 2B] Schematic diagram showing another connector according to an exemplary embodiment of the present disclosure. [Figure 2C] Schematic diagram showing the top surface of the housing and the adhesive patch of FIG. 2 according to an exemplary embodiment of the present disclosure. [Figure 2D] Schematic diagram showing the bottom surface of the housing and the adhesive patch of FIG. 2 according to an exemplary embodiment of the present disclosure. [Figure 2E] Schematic diagram showing the side surface of the housing and the adhesive patch of FIG. 2 according to an exemplary embodiment of the present disclosure. [Figure 2F] Schematic diagram showing a cap according to an exemplary embodiment of the present disclosure. [Figure 2G] Schematic diagram showing another top surface of the housing and the adhesive patch of FIG. 2 according to an exemplary embodiment of the present disclosure. [Figure 2H] Schematic diagram showing a drug pump according to an exemplary embodiment of the present disclosure. [Figure 2I] Schematic diagram showing another housing according to an exemplary embodiment of the present disclosure. [Figure 2J] Schematic diagram showing the interior of the housing of FIG. 2I according to an exemplary embodiment of the present disclosure. [Figure 2K] Schematic diagram showing the bottom of the housing of FIG. 2I according to an exemplary embodiment of the present disclosure. [Figure 2L] Schematic diagram showing a perspective view of the housing of FIG. 2I according to an exemplary embodiment of the present disclosure. [Figure 2M] Schematic diagram showing a wearable pump according to an exemplary embodiment of the present disclosure. [Figure 2N] Schematic diagram showing the back of the wearable pump of FIG. 2M according to an exemplary embodiment of the present disclosure. [Figure 2O] Schematic diagram showing a wearable pump strap according to an exemplary embodiment of the present disclosure. [Figure 2P] Schematic diagram showing the wearable pump of FIG. 2M with a cover according to an exemplary embodiment of the present disclosure. [Figure 2Q]A schematic diagram of another wearable pump according to an exemplary embodiment of the present disclosure. [Figure 2R] A schematic diagram of a wearable pump attached to a user, according to an exemplary embodiment of the present disclosure. [Figure 2S] A schematic diagram of another wearable pump according to an exemplary embodiment of the present disclosure. [Figure 2T] A schematic diagram of a wearable pump attached to a user, as shown in Figure 2S, according to an exemplary embodiment of the present disclosure. [Figure 2U] A schematic diagram of another wearable pump according to an exemplary embodiment of the present disclosure. [Figure 2V] A schematic diagram of a wearable pump attached to a user, as shown in Figure 2U, according to an exemplary embodiment of the present disclosure. [Figure 2W] A schematic diagram of a needle guide system according to an exemplary embodiment of the present disclosure. [Figure 2X] Another schematic diagram of the needle guide system of Figure 2W, according to an exemplary embodiment of the present disclosure. [Figure 3A] A schematic diagram of a step in which the injection lead body is positioned substantially parallel to the nerve, according to an exemplary embodiment of the present disclosure. [Figure 3B] A schematic diagram of a step in which the injection lead body is positioned substantially parallel to the nerve, according to an exemplary embodiment of the present disclosure. [Figure 3C] A schematic diagram of a step in which the injection lead body is positioned substantially parallel to the nerve, according to an exemplary embodiment of the present disclosure. [Figure 3D] A schematic diagram of a step in which the injection lead body is positioned substantially parallel to the nerve, according to an exemplary embodiment of the present disclosure. [Figure 3E] A schematic diagram of a step in which the injection lead body is positioned substantially parallel to the nerve, according to an exemplary embodiment of the present disclosure. [Figure 3F] A schematic diagram of a step in which the injection lead body is positioned substantially parallel to the nerve, according to an exemplary embodiment of the present disclosure. [Figure 3G] A schematic diagram showing an injection lead body inserted into a nerve sheath according to an exemplary embodiment of the present disclosure. [Figure 3H]A schematic diagram of the process of placing the injection lead body within a nerve sheath according to an exemplary embodiment of the present disclosure. [Figure 3I] A schematic diagram of the process of placing the injection lead body within a nerve sheath according to an exemplary embodiment of the present disclosure. [Figure 3J] A schematic diagram of the process of placing the injection lead body within a nerve sheath according to an exemplary embodiment of the present disclosure. [Figure 3K] A schematic diagram of the process of placing the injection lead body within a nerve sheath according to an exemplary embodiment of the present disclosure. [Figure 3L] A schematic diagram of the process of placing the injection lead body within a nerve sheath according to an exemplary embodiment of the present disclosure. [Figure 3M] A schematic diagram of the process of placing the injection lead body within a nerve sheath according to an exemplary embodiment of the present disclosure. [Figure 4A] A schematic diagram showing an implantable pulse generator (IPG) according to an exemplary embodiment of the present disclosure. [Figure 4B] A schematic diagram showing a receive (RX) module and a transmit (TX) module according to an exemplary embodiment of the present disclosure. [Figure 5A] A schematic diagram showing another multimodal system according to an exemplary embodiment of the present disclosure. [Figure 5B] A schematic diagram showing another multimodal system according to an exemplary embodiment of the present disclosure. [Figure 5C] A schematic diagram showing another multimodal system according to an exemplary embodiment of the present disclosure. [Figure 6] A flowchart of two methods, for example, multimodal stimulation, according to an exemplary embodiment of the present disclosure. [Figure 7] A flowchart illustrating the arrangement of the injection lead body according to an exemplary embodiment of the present disclosure. [Figure 8A] A schematic diagram of an electron configuration detector according to an exemplary embodiment of the present disclosure. [Figure 8B] A schematic diagram of a visual arrangement detector according to an exemplary embodiment of the present disclosure. [Figure 9]Another schematic diagram of a multimodal system according to an exemplary embodiment of the present disclosure. [Figure 10] A flowchart for training a machine learning model according to an exemplary embodiment of this disclosure. [Figure 11] A schematic diagram showing an example of a computing device according to an exemplary embodiment of the present disclosure. [Modes for carrying out the invention]

[0013] While various modifications and alternative forms are possible for the embodiments of this disclosure, certain examples are shown in the drawings and described in detail. However, this disclosure is not limited to the specific embodiments described. Rather, the following description and drawings are intended to cover all modifications, equivalents, and alternative forms that fall within the spirit and scope of the invention.

[0014] Numerous embodiments are described and illustrated herein. The embodiments described are not limited to a single aspect or example, nor are they limited to any combination and / or substitution of such aspects and / or examples. Furthermore, each aspect and / or example of an embodiment described may be implemented independently or in combination with one or more other aspects and / or examples of the embodiment described. For brevity, certain substitutions and combinations are not individually described and / or illustrated herein. In particular, embodiments or examples described herein as “exemplary” should not be construed as being preferable or advantageous to other embodiments or examples. Such embodiments are intended to be “examples.”

[0015] In this specification, the terms “equipped,” “possessing,” “containing,” and similar terms do not imply non-exclusive inclusion, and include processes, methods, articles, or apparatus containing the enumerated elements, even if they have other elements not expressly enumerated or other elements not specific to the process, method, article, or apparatus, rather than only those elements. The term “exemplary” is used to mean “example” and not “ideal.” Furthermore, terms such as “first,” “second,” etc., in this specification do not indicate order, quantity, or importance, but are used to distinguish elements or structures. Furthermore, the term “one” in this specification does not indicate a limit on quantity, but indicates that there is one or more items being referenced.

[0016] The term "tip" or its variation refers to the part of the device furthest from the operator during a procedure. Conversely, the term "base" or its variation refers to the part of the device closest to the operator. Furthermore, the terms "approximately," "about," "roughly," and "about" usually mean + / - 10% of the indicated value.

[0017] One way to manage postoperative pain is to administer anesthetics over an extended period using a catheter and pump. However, given the toxicity of such anesthetics and the size and complexity of the catheter and pump, their standard use is limited to the first few days after surgery.

[0018] Peripheral nerve stimulation can also be used to reduce postoperative pain, but this requires a different procedure. In this procedure, an electrode-equipped lead is inserted near the nerves that supply the surgical site. A pulse generator is connected to the proximal end of the lead, and electrical stimulation is sent to the nerve via the electrode at the tip of the lead. A fairly high percentage of cases are not completely effective in relieving postoperative pain with nerve stimulation. However, such cases cannot be identified until the procedure is performed.

[0019] Vilims' U.S. Patent No. 7,386,350 describes a lead that combines electrical and chemical stimulation for use in intervertebral discs to promote tissue regeneration and repair.

[0020] Sinha's U.S. Patent Application Publication No. 2021 / 0330977 describes a similar composite catheter used for pain management. The catheter has electrodes for delivering electrical stimulation to the target nerve, as well as a lumen for delivering an anesthetic to the target nerve. To avoid interference between the anesthetic and the electrical stimulation, Sinha proposes positioning the exit port away from the electrodes. However, if the port and electrodes are located at different distances from the nerve, problems may arise because the power requirements, buoyancy effect, concentration and dilution at the nerve, and consequently the effectiveness, are affected by proximity.

[0021] Other drawbacks of such pain management systems in conventional technology include practical challenges in self-management of pain at home, such as the need for patients to properly administer anesthetics and inject using injection ports, the possibility of stimulation electrodes shifting, and the potential for infection. Furthermore, conventional technology has not considered how to efficiently convert postoperative (subchronic) pain management into chronic pain management when necessary.

[0022] The embodiments disclosed herein address the ongoing need for improvements in multimodal (chemical and electrical) pain management systems. For example, it is desirable to configure the system and / or method of use so that one method of treatment does not affect other methods of treatment. It is also desirable to perform selective treatment (e.g., chemical stimulation and / or electrical stimulation) to achieve motor pain management, sensory pain management, vasodilation and / or arteriovenous fistula (AVF) maturation. Furthermore, it is desirable that such systems and / or methods be configured for use by patients at home without the presence of medical staff. In addition, it is desirable that such systems be configured to be convertible into partially or fully implantable systems to address chronic pain management as needed. In this disclosure, several different embodiments are proposed to address the above needs.

[0023] Figure 1 schematically shows a part of a multimodal pain management system. This system generally has an infusion lead assembly 100 configured to be detachably connected to a drug pump 200 as shown in Figure 1A, a pulse generator 300 as shown in Figure 1B, or a combined drug pump and pulse generator 200 / 300 as shown in Figure 1C, via a housing 140, a connector 150, and corresponding infusion tubes 210 and cables 310. The housing 140 is fixed to the epidermis via an adhesive patch 160 to restrict movement. The upper part of the adhesive patch 160 is attached (e.g., permanently) to the underside of the housing 140. The bottom of the patch 160 has an adhesive layer (e.g., suitable for use for about 10-14 days in a normal living environment), which is covered with a removable covering (e.g., removable wax paper) until it is ready to be attached to the epidermis.

[0024] The infusion lead assembly 100 has a tubular infusion lead body 110 whose proximal end is connected to a housing 140. An infusion lumen (not shown) extends inside the infusion lead body 110 and communicates with an outlet port 118 and a drug pump 200 via the housing 140, a connector 150, and an infusion tube 210 (for example, if the connector 150 is connected to the housing 140). The infusion lead body 110 further has one or more proximal electrodes 112 and one or more proximal electrodes 114 which are in contact with a pulse generator 300 via a wire (not shown) embedded in the wall of the infusion lead body 110, an internal wire (not shown) extending through the housing 140 and the connector 150, and a cable 310. The internal wire embedded in the wall of the infusion lead body 110 extends along at least a portion of the infusion lumen of the infusion lead body 110.

[0025] The injection lead body 110, when inserted into and / or adhered to the skin as shown in the figure, has a length suitable for positioning the tip electrode 112 and exit port 118 near nerves distributed at the surgical site. Such a configuration allows a drug (e.g., anesthetic solution) to be delivered from the drug pump 200 to the nerve via the port 118, and electrical stimulation to be delivered from the pulse generator 300 to the nerve via the electrode 112, providing a combination of chemical and electrical nerve block effects. The exit port 118 may be a single or multiple openings.

[0026] The drug pump 200, pulse generator 300, connector 150, housing 140, and / or one or more other components disclosed herein may include or be associated with a safety mechanism (e.g., they may communicate with the safety mechanism). The safety mechanism may be configured to prevent chemical and / or electrical stimuli exceeding a threshold effect from being applied to the user (e.g., to prevent accidental stimuli). The safety mechanism may be implemented as a software component, a hardware component, and / or a firmware component. The safety mechanism may prevent or suppress accidental stimuli and may be configured to be deactivated by the user (e.g., patient or administrator). Threshold characteristics may include, for example, a threshold quantity (e.g., approximately 2 cc, approximately 5 cc, approximately 30 V), a threshold time (e.g., approximately 5 seconds, approximately 20 seconds), a threshold frequency (e.g., within approximately 3 hours of the previous dose, approximately once a day), etc. For example, the safety mechanism may be software or an electronic component that observes the chemical and / or electrical characteristics (e.g., quantity, duration, time, etc.) of the chemical and / or electrical stimuli. The safety mechanism can observe one or more characteristics using one or more sensors, such as a volume sensor (e.g., configured to observe the amount of drug), a clock, a counter, or a signal sensor. The safety mechanism can electronically prevent chemical and / or electrical stimuli (e.g., for a predetermined period of time) by transmitting a signal to a component (e.g., a drug pump 200, a pulse generator 300, a physical block component, etc.). In another example, the safety mechanism may be a physical component (e.g., a ticker, a physical counter, a lock, a valve, a switch, etc.) configured to detect or prevent chemical and / or electrical stimuli (e.g., for a specified period of time or when a specified amount is exceeded), or may be associated with a physical component. The physical component may block or suppress chemical and / or electrical stimuli in response to a signal or when it is determined that the characteristics of the chemical and / or electrical stimuli have exceeded a threshold.

[0027] Electrical stimulation can be performed in unipolar or bipolar mode. For example, one of the tip electrodes 112 functions as the cathode and the other tip electrode 112 functions as the anode. Alternatively, both tip electrodes 112 may be electrically short-circuited to function as a combined anode or cathode, and the proximal electrode 114 may function as either the cathode or the anode. The proximal electrode 114 may also function as effective ground.

[0028] The injection lead body 110 may further have a fastener 113 or fastener 113A, or may be attached to the fastener 113 or fastener 113A. The fastener 113 and / or fastener 113A are molded to fix the injection lead body 110 in place so as to position the injection lead body 110 near the nerve and / or keep it substantially parallel. The fastener 113 and / or fastener 113A may be a cuff or other attachment mechanism. The fastener 113 and / or fastener 113A prevent the overall movement of the injection lead body 110 and prevent or restrict the movement of the lead body 110. The fastener 113 and / or fastener 113A may be configured to include a tension relief mechanism (for example, by winding the fastener 113 and / or fastener 113A into a coil). The tension-relaxing mechanism can prevent or restrict the movement and / or detachment of the fastener 113, fastener 113A, and / or the injection lead body 110. The fastener 113 and / or fastener 113A may include bioabsorbable or biodegradable materials as described herein. The fastener 113 of the injection lead body 110 is attached to tissue (e.g., nerve-adjacent tissue) by any applicable connection method, such as force connection, friction connection, adhesive connection, or a combination thereof. For example, the fastener 113 has a proximal end attached to the injection lead body 110 and a hook-shaped or C-shaped tip. The hook-shaped or C-shaped tip engages with the tissue so that the tissue is positioned within the hook or C-shaped portion of the tip of the fastener 113. As will be described later with reference to Figures 3A to 3F, the tip of the fastener 113 is locked into the tissue by rotating the injection lead body 110 and / or injection lead assembly 100 during insertion of the injection lead body 110 and / or injection lead assembly 100. The fastener 113A is positioned near the housing 140 and is attached to the tissue near the housing 140, the patient's skin (e.g., the underside of the patient's skin) and / or the adhesive patch 160. The fastener 113A may have a magnetic or metal component that magnetically attracts the corresponding magnetic or metal component of the housing 140.The injection lead body 110 may or may not have a fastener, may have a fastener 113 or fastener 113A, may have fasteners 113 and 113A, or may have other applicable mechanisms for securing the injection lead body 110 so that it is kept close to and / or substantially parallel to any nerve. The injection lead body 110 may be braided to prevent curling.

[0029] Figure 1D is a schematic diagram showing another drug pump 180 according to an exemplary embodiment of the present disclosure. The drug pump 180 is a spring-loaded drug pump that is operated by pressing an actuation button 182. When the drug pump 180 is operated, the fluid (such as a drug) contained within the drug pump 180 is discharged from port 183. When the drug pump 180 is operated by pressing the actuation button 182, the fluid passes through port 183 into an internal lumen (e.g., an internal lumen 154 described later) and / or is delivered to a delivery site (e.g., near a nerve). The drug pump 180 may have an inlet 184 configured to recover fluid from an external container (not shown), as will be further described with reference to Figures 1E and 1F.

[0030] Figure 1E is a schematic diagram showing the inside of the drug pump 180. As shown in the figure, the drug pump 180 includes a spring system comprising one or more elastic members such as a spring 186. When the activation button 182 is pressed, the spring 186 is pressed down and moves to a first position (e.g., a loaded position). When the activation button 186 is pressed, the activation button 186 is locked in the pressed-down position for a certain period of time until the user releases the button and / or the button is released based on a signal. For example, a safety mechanism described herein generates a signal to release the activation button 186 after a threshold time has elapsed. The threshold time is determined by a machine learning model and / or based on the user's treatment plan. By locking the activation button 186, it is possible to suppress or prevent the accidental administration of more medication than intended. Once the pressing operation is complete (e.g., when the activation button 182 is released, the lock is released, a signal from the safety mechanism occurs, etc.), the loaded spring 186 expands from the first position to a second position (e.g., an unloaded position). When the spring 186 moves from the first position to the second position, the actuation button 182 extends to the first position (e.g., the initial position), and when the actuation button 182 is pressed, additional fluid is discharged from the port 183. The movement of the spring 186 from the first position to the second position also creates a suction state, and suction pressure is applied through the inlet 184. The inlet 184 is connected to an external container that holds additional fluid (e.g., the same fluid or a different fluid discharged by the drug pump 180). The suction pressure allows the additional fluid in the external container to be collected by the drug pump 180 through the inlet 184.

[0031] The drug pump 180 has a valve system 190 (e.g., a double valve system) that allows fluid to be discharged from the drug pump 180 via port 183 when the activation button 182 is pressed. For example, when fluid is discharged from the drug pump 180 via port 183, a first valve component (not shown) of the valve system 190 is in the open position. The first valve component moves to the closed position after the fluid has been discharged, and a second valve component (not shown) moves from the closed position to the open position, thereby introducing suction pressure via the inlet 184. Thus, the valve system 190 facilitates the discharge of fluid via port 183 and further facilitates the recovery of additional fluid from an external container via the inlet 184. The valve system 190 and / or the second valve component can be configured so that the amount of fluid recovered from the external container does not exceed a certain amount. For example, the valve system 190 and / or a second valve component are configured to ensure that only a certain amount (e.g., about 2 cc) of fluid is collected by the drug pump 180, thereby preventing the accidental delivery of more than a certain amount of fluid.

[0032] Figure 1F is a flowchart illustrating an example of the operation of the drug pump 180. As shown in step 192, when the activation button 182 is pushed down from the first position to the second position, fluid is discharged from the drug pump 180 to the device (e.g., connector 150) via the port 183. In step 194, the activation button 182 is in the second position, and in this state, the spring 186 in Figure 1E is in the first position (e.g., the loaded position), and fluid is being discharged via the port 183. The activation button returns to the first position as the spring 186 moves from the first position to the second position (e.g., the unloaded position). This movement generates the aforementioned suction pressure, and additional fluid is recovered from the external container into the drug pump 180 via the inlet 184 in Figures 1D and 1E.

[0033] Figure 2 shows a more detailed top view of the housing 140 and the connector 150. The connector 150 has a pair of tabs 151 that snap-fit ​​into corresponding recesses 141 within the housing 140. The connector 150 can be connected to or attached to the housing 140 in any applicable way, and is not limited to the snap-fit ​​connection shown in Figure 2, but may use, for example, another snap-fit ​​connection, force connection, fasteners or a combination thereof. The connector 150 can be removed from the housing 140 by any applicable way (e.g., threshold force, release mechanism, button or other input). The connector 150 can be removed from the housing 140 without displacing or interfering with the injection lead body 110. The connector 150 has an insert-molded subcutaneous injection needle 152 that communicates with the injection tube 210 via an internal lumen 154, and one or more metal pins 153 that are conductive to the cable 310 via an internal conductive trace 155. Similarly, the housing 140 has a subcutaneous injection needle receptacle 142 and one or more pin receptacles 143, each with a gasket to form a fluid seal. The metal pin 153, internal conductive transformer 155, pin receptacles 143 and / or conductive transformer 145 have electrical surfaces for transmitting electrical signals between each component. The gaskets can be combined with one or more in-line filters to inhibit bacterial intrusion. For example, the in-line filters may contain or be coated with antimicrobial material. The lumen 144 within the housing 140 communicates with the internal lumen of the injection lead body 110, and thus communicates with the outlet port 118. Similarly, the conductive trace 145 within the housing 140 is conductive with electrodes 112, 114. When the connector 150 engages with the housing 140 (for example, by sliding toward the housing 140), the male connector of the connector 150 functionally engages with the corresponding female connector in the housing 140, thereby functionally connecting the infusion lead body 110 to the drug pump 200 and / or pulse generator 300.

[0034] The housing 140 further has a gasket 146 that forms a fluid seal around the insertion needle (described elsewhere in this specification) and closes when the insertion needle is later removed. The connector 150 may be configured to provide only electrical stimulation as shown in Figure 2A, or to provide only chemical stimulation as shown in Figure 2B. As shown in Figure 2A, in one embodiment, the connector 150 is manufactured or modified to include an internal conductive trace 155, one or more metal pins 153 and a pair of tabs 151 and / or other applicable connecting elements. As shown in Figure 2B, in one embodiment, the connector 150 is manufactured or modified to include an insert-molded subcutaneous injection needle 152, an internal lumen 154 and a pair of tabs 151 and / or other applicable connecting elements. In one embodiment, the connector 150 is a replaceable part, and the connector 150 in Figure 2, the connector 150 in Figure 2A, the connector 150 in Figure 2B and / or the cap 150A in Figure 2F are replaceable and / or disposable. Alternatively or additionally, the connector 150 may be modular, and one or more components of the connector 150 (e.g., one or more metal pins 153, internal conductive traces 155, insert-molded subcutaneous injection needles 152, or internal lumen 154) may be detachable from the connector 150.

[0035] Figures 2C to 2E schematically show details of modified housings 140 and adhesive patches 160. Figure 2C is a top view, Figure 2D is a bottom view, and Figure 2E is a side view. In this embodiment, the adhesive patch 160 has an open space 162 surrounded by an outer periphery 164 that is thicker than the injection lead body 110. This configuration allows the excess length of the injection lead body 110 to be positioned, for example, within the open space 162 (e.g., spirally). The upper part of the open space 162 has an adhesive surface for fixing the injection lead body 110 (e.g., spirally), and the bottom of the outer periphery 164 has an adhesive surface for fixing the assembly to the skin. This configuration allows the injection lead body 110 and the corresponding electrodes 112 and exit port 118 to be positioned at a desired longitudinal position (e.g., parallel to the nerve), regardless of the length of the injection lead body 110, and also suppresses movement of the injection lead body 110. Furthermore, this configuration allows the excess length of the injection lead body 110 to be released even if the housing 140 accidentally detaches from the user's skin. For example, if the housing 140 accidentally detaches from the user's skin, the release of the excess length of the injection lead body 110 can prevent or suppress the portion of the injection lead body 110 located inside the user's body from detaching or being pulled out.

[0036] In one embodiment, the excess length of the injection lead body 110 is cut off from the remaining portion of the injection lead body 110 (e.g., the portion inserted into the patient's body) or removed by other means. The excess portion on the proximal end of the injection lead body 110 can be cut off by any applicable method, such as a blade, a sharp surface, a laser, perforation, or a combination thereof. The remaining portion of the injection lead body 110 may be connected to the housing 140. For example, the lumen 144 of the housing 140 may be connected to the internal lumen of the remaining portion of the injection lead body 110. Similarly, the conductive trace 145 of the housing 140 may be connected to the internal wire of the injection lead body 110. This configuration allows the injection lead body 110 and the corresponding electrode 112 and exit port 118 to be positioned at a desired longitudinal position (e.g., parallel to the nerve) regardless of the original length of the injection lead body 110, and also suppresses movement of the injection lead body 110.

[0037] Figure 2F schematically shows the cap 150A. The cap 150A is connected to the housing 140 when the connector 150 is not connected to the housing 140. The connector 150 can be removed when electrical or chemical stimulation is not required (e.g., during activity). By connecting the cap 150A to the housing 140, the risk of infection can be reduced because contaminants (bacteria, etc.) can be prevented from entering the subcutaneous injection needle receptacle 142 and one or more pin receptacles 143.

[0038] The cap 150A is connected to the housing 140 in any suitable manner to achieve complete or partial sealing of the subcutaneous injection needle receptacle 142 and one or more pin receptacles 143 to the environment. The cap 150A has a pair of tabs 151A that snap into corresponding recesses 141 in the housing 140. The cap 150A also has a lumen insert 152A formed to fit into the lumen 144 and a trace insert 153A formed to fit into the conductive trace 145. The lumen insert 152A and / or trace insert 153A are treated with antimicrobial coatings (coatings, finishes, materials, etc.) to further reduce the risk of infection. For this reason, the lumen insert 152A and trace insert 153A are formed to fit into the lumen 144 and conductive trace 145, respectively, so as to apply antimicrobial treatment to the lumen 144 and conductive trace 145. By connecting the cap 150A to the housing 140, the risk of exposure to contaminants can be reduced, and the antimicrobial treatment applied via the cap 150A can be applied to the gasket, filter, opening, internal space and / or the inner surface of the lumen 144 and / or the conductive trace 145, thereby removing contaminants. The cap 150A can be housed or placed within the antimicrobial components when removed from the housing 140, thereby allowing the antimicrobial treatment of the cap 150A to be performed again while the cap 150A is removed from the housing 140. Alternatively or additionally, the antimicrobial treatment of the cap 150A may be periodically re-performed by applying the antimicrobial treatment to the cap 150A (e.g., the lumen insert 152A and the trace insert 153A). A safety mechanism configured to facilitate chemical and / or electrical stimulation based on threshold characteristics may be included in or associated with the cap 150, cap 150A, housing 140 and / or one or more of the other components described herein.

[0039] Figure 2G is a schematic diagram showing the top view of the housing 140 and the adhesive patch 160. The housing 140 has pressure buttons 280A and 280B. When pressure buttons 280A and 280B are activated (for example, pressed), pressure rods 282A and 282B apply pressure to or around the gasket 146, respectively. The pressure on or around the gasket 146 is also transmitted to the needle 50, which will be described later. The pressure holds the needle 50 in place and prevents it from moving forward or backward from its current position. This pressure allows the needle 50 and the injection lead body 110 to remain substantially stationary relative to each other. The buttons 280A and 280B and the pressure rods 282A and 282B can be operated with one hand to prevent or restrict the movement of the needle 50 relative to the injection lead body 110. Although it is explained that pressure is applied by activating pressure buttons 280A and 280B, buttons 280A and 280B and / or pressure rods 282A and 282B may be configured to apply pressure when buttons 280A and 280B are not activated and to release pressure when buttons 280A and 280B are activated. In such embodiments, one or more additional components such as levers, hinges, or releases can be used to convert the operating pressure (e.g., the pressure applied to activate buttons 280A and 280B) and release the pressure applied by pressure rods 282A and 282B.

[0040] Figure 2H shows a schematic diagram of the drug pump 200A. The drug pump 200A may be identical or similar to the drug pump 200 described above. The drug pump 200A has a knob 290, one or more handles 292 and / or a drug container 294 at least partially housed within the drug pump 200A. The drug container 294 is configured to hold a predetermined amount of one or more drugs (e.g., about 20 cc each drug). The knob 290 is rotated manually or automatically, and with each rotation a predetermined amount (e.g., about 5 cc) of the drug contained in the drug container 294 is discharged. The operation of the knob 290 may be controlled by a safety mechanism, as described herein, and the safety mechanism may be configured to prevent accidental rotation and / or excessive rotation of the knob 290 (e.g., to prevent drug overdose, to prevent frequent administration of drugs exceeding a threshold amount, etc.). Although a rotatable knob 290 is shown, the mechanism for dispensing any amount of the drug contained in the drug container 294 may be any applicable operating mechanism. For example, the operating mechanism may be a button, a slider, an electronic input receiver, a digital input receiver, etc. Furthermore, although a single drug container 294 is shown, multiple drug containers 294 containing the same or different drugs may be provided. In embodiments where multiple drug containers are provided, each of the multiple drug containers may be provided with an operating mechanism. Such operating mechanisms can be configured to dispense all or part of the drug contained in the corresponding drug container based on each operation using the operating mechanism.

[0041] The knob 290 can be operated by rotating it by any amount. This amount may be a predetermined amount. For example, one or more locking parts (not shown) may apply a reaction force to the rotational force of the knob 290, so that after the knob 290 has partially rotated, the rotation of the knob 290 is temporarily stopped as a result of the reaction force. One or more locking parts can prevent accidental administration of an excessive amount of drug by preventing or suppressing accidental rotation of the knob. When the knob 290 is rotated, a predetermined amount (e.g., about 5 cc) of drug contained in the drug container 294 is discharged. After the rotation of the knob 290 is temporarily stopped, it is restarted for the next partial rotation, and the next partial rotation discharges an additional amount of drug. When the knob 290 is rotated, the drug contained in the drug container 294 is discharged due to the pressure applied by the rotation of the knob 290, the opening created by the rotation of the knob 290, etc.

[0042] The drug container 294 is formed from any suitable material configured to contain a drug. The drug container 294 is sealed so that the drug contained within it is not discharged unless an actuation mechanism is activated, such as the rotation of the knob 290. The drug container 294 can be, but is not limited to, polyvinyl chloride (PVC), plastic, glass, or any other suitable material configured to contain a drug. The drug container 294 may be a compartment, a bag, or the like. The drug container 294 may be configured to contain a reusable drug holder (e.g., a replaceable bag) which can be replaced by the user (e.g., if all or most of the drug in the current drug holder is discharged). The drug container 294 and / or drug holder contain one or more drugs in quantities corresponding to a predetermined number of actsuations (e.g., about 4 to 6 actsuations).

[0043] In one embodiment, the actuation mechanism (e.g., a knob 290) is automatically actuated based on an electronic signal generated by a controller (e.g., an external controller further described herein). A motor or other component configured to actuate the actuation mechanism may also be triggered by the electronic signal. The electronic signal may further indicate the degree of actuation of the actuation mechanism. For example, depending on the degree of actuation, a corresponding amount of actuation (e.g., rotation) occurs. The corresponding amount of actuation results in a corresponding amount of drug being discharged from the drug container 294, with greater actuation resulting in the discharge of more drug.

[0044] One or more handles 292 protrude from the drug pump 200A. When the drug pump 200A is positioned against a part of the user's body, the handles 292 are positioned against that part of the user's body, and stability is provided by the bases of the drug pump 200A and / or one or more handles 292. Alternatively or additionally, a strap (not shown) may extend through one or more handles 292. The strap may extend not only to one or more handles 292 but also to a part of the user's body (e.g., ankle, shoulder, arm, leg, etc.) so that the drug pump 200A is secured to the part of the user's body via the strap. As an example, the strap may be self-fastening (e.g., a Velcro® strap) with one part of the strap attached to another part of the strap.

[0045] Figure 2I is a schematic diagram of another housing 140A according to an exemplary embodiment of the present disclosure. Housing 140A may be the same as, similar to, or different from, housing 140 described above. Housing 140A has a rear section including an infusion tube port 210A and a cable port 310A. In one embodiment, housing 140A may be connected (e.g., directly) to a pulse generator 300 via cable 310, or to a drug pump 200 (e.g., directly) via infusion tube port 210A. For example, infusion tube port 210A may receive an infusion tube 210 or be configured to connect to an infusion tube 210. Cable port 310A may receive a cable 310 or be configured to connect to a cable 310. In another embodiment, housing 140A is connected to a connector (e.g., connector 150, connector 150A, etc.). For example, the injection tube port 210A is connected to the insert-molded subcutaneous injection needle 152 of the connector 150, and the cable port 310A is connected to the internal lumen 154 of the connector 150.

[0046] Figure 2J is a schematic diagram of the inside of the housing 140A, Figure 2K is a schematic diagram of the bottom of the housing 140A, and Figure 2L is a schematic perspective view of the housing 140A. As shown in Figures 2J to 2L, the housing 140A is provided with an internal injection tube port 210B that is connected to and / or communicates with the injection tube port 210A. The housing 140A also has an internal cable port 310B that is connected to and / or communicates with the cable port 310A. The internal injection tube port 210B has a lumen (e.g., lumen 144) that communicates with the injection tube 210, an internal lumen 154, and / or the injection lead body 110A. The injection lead body 110A may be the same as or similar to the injection lead body 110 described above. As previously mentioned with respect to the injection lead body 110, a wire or electrical trace (not shown) may be provided for connecting the internal cable port 310B to the internal wire of the injection lead body 110A (for example, via the internal injection tube port 210B) in order to provide electrical conductivity between the cable 310 and a wire (not shown) embedded in the wall of the injection lead body 110A. The bottom surface of the housing 140A shown in Figure 2K may be formed of an adhesive (for example, an adhesive backed with foam) for fixing the housing 140A to a surface such as the user's skin, or it may contain an adhesive. The inner portion of the housing 140A, including the internal injection tube port 210B and the internal cable port 310B, may be filled with an electrical insulating material (for example, a filler material) to insulate the wire and / or electrical trace connecting the internal cable port 310B and the internal wire of the injection lead body 110A. One or more components associated with the injection tube port 210A, the internal injection tube port 210B, the cable port 310A, the internal cable port 310B, and / or the housing 140A may be equipped with a safety mechanism as described herein, which is configured to prevent accidental and / or excessive output of chemical and / or electrical stimuli. As previously stated, the safety mechanism can be made available using electrical signals, and the chemical and / or electrical stimuli are controlled in accordance with the electrical signals.For example, based on a signal generated by a safety mechanism, electrical operation via the internal cable port 310B is suspended for a certain period of time. In another example, the internal injection tube port 210B has a valve component configured to close for a certain period of time after a chemical stimulus is provided via the internal tube port 210. A signal to initiate the closing of the valve is generated by the safety mechanism, and a signal to terminate the closing of the valve is generated by the safety mechanism or automatically, for example, based on a period of time.

[0047] In one embodiment, one or more drugs are contained within a strap that can be secured to a part of the user's body. The strap is elastic and / or adaptable (e.g., flexible or with a threshold of flexibility) and may be self-adhesive or can be secured to a part of the user's body. The strap may be a drug holder configured to discharge one or more drugs (e.g., an intravenous (IV) bag measuring approximately 2.54 cm (approximately 2 inches) x approximately 15.24 cm (approximately 6 inches)), or may include a drug holder. The drug holder may be connected to a one-way check valve (e.g., a "T" shaped) configured to discharge drugs from the drug holder. For example, a syringe or prime valve (e.g., having a capacity of approximately 3 cc) may be connected to the drug holder and configured to draw drugs from the drug holder through a tube (e.g., via tube 210) that communicates with the user via the one-way check valve. The drug holder may be embedded within the strap together with one or more of the tubes and valves, etc., or may be attached to the strap. Therefore, the strap is configured to hold one or more drugs via drug holders, and one or more drugs are dispensed from the strap and received by the user. In one embodiment, the strap is equipped with one or more drug holders that can hold a predetermined amount of drug (e.g., about 100cc to about 500cc).

[0048] In one embodiment, one or more drugs are contained within a wearable pump that is secured to the user's body (for example, using a strap, adhesive, etc.). Figure 2M is a schematic diagram of a wearable pump 296A according to an exemplary embodiment of the present disclosure, and Figure 2N is a rear view of the wearable pump 296A. As shown in Figure 2M, the wearable pump 296A has a drug-holding component 296C molded to receive the drug (for example, into a chamber). The drug-holding component 296C has a fluid container for holding the drug and further has a recovery component (for example, a plunger) for discharging the drug from the drug-holding component 296C or recovering the drug into the drug-holding component 296C. Although Figure 2M shows a retrieval component (such as a plunger) exposed from the top surface of the retaining component 296C for easy access, the retrieval components, some components, and / or all movable components that constitute and / or are associated with the retaining component 296C may be fixed or inaccessible while the wearable pump, such as the wearable pump 296A, is in operation and / or inactive. For example, as shown in Figures 2P, 2R, and 2U, the retrieval components and / or other movable components may be configured not to extend beyond the boundaries of each wearable pump, thereby preventing unintended contact with the components or accidental movement of the components. The wearable pump 296A can be connected to one or more straps 296B, as shown in Figure 2O. One or more straps 296B are configured to secure the wearable pump 296A to a part of the user's body, as described herein. The wearable pump 296A is connected to a connector (e.g., connector 150, connector 150A, etc.) and / or directly to the housing 140A to supply the drug to the injection lead body (e.g., injection lead body 110, injection lead body 110A, etc.).

[0049] Figure 2P is a schematic diagram of a wearable pump 296A having a cover 296D according to an exemplary embodiment of the present disclosure. Figure 2P shows the cover 296D in the closed position 295A, a rear view of the cover 296D in the open position 295B, and a front view of the cover 296D in the open position 295C. The cover 296D can cover all or part of the retaining component 296C. For example, the cover 296D is configured to cover all or part of the retaining component 296C so that the user does not accidentally touch, move, or unintentionally operate the retaining component 296C. In one embodiment, the cover 296D is molded to include a chamber (not shown) for containing a drug. In this embodiment, when the cover 296D is in the open position, the retaining component 296C can recover a certain amount of drug from the cover 296D (for example, from the chamber of the cover 296D). For example, during use, when the cover 296D is in the closed position, the drug can be discharged from the retaining part 296C. By moving the cover 296D to the open position, an additional amount of drug can be recovered from the cover 296D (e.g., from the chamber of the cover 296D) into the retaining part 296C (for example, when the plunger component associated with the retaining part 296C is actuated, a certain amount of drug is sent from the chamber of the cover 296D to the retaining part 296C by suction pressure).

[0050] Figure 2Q is a schematic diagram of another wearable pump 297A according to an exemplary embodiment of the present disclosure. The wearable pump 297A is similar to the wearable pump 296A. The wearable pump 297A is configured to house one or more cartridges 297B containing one or more drugs. The cartridges 297B are replaceable, and the user can remove a first cartridge 297B from the wearable pump 297A and insert a second cartridge 297B into the wearable pump 297A. As shown in the figure, one or more cartridges 297B are housed in the housing component of the wearable pump 297A. Also as shown in the figure, it is possible to insert or remove the cartridges 297B from the wearable pump 297A when the cover 297D is in the open or closed position. In one embodiment, instead of cartridges 297B, a retaining component 297C is inserted into the wearable pump 297A. Alternatively or additionally, one or more cartridges 297B may be refilled using retaining part 297C. The wearable pump 297A has a cover 297D, which is similar to the cover 296D mentioned above with reference to Figure 2P.

[0051] Figure 2R is a schematic diagram of a wearable pump 297A attached to a user, according to an exemplary embodiment of the present disclosure. As shown in the figure, the wearable pump 297A can be attached to a part of the user's body (e.g., a leg). The wearable pump 297A may be attached to the user's body part via an adhesive (not shown). Alternatively, the wearable pump 297A may be attached to the user's body part via a strap (e.g., strap 296B).

[0052] Figure 2S is a schematic diagram of another wearable pump 298A according to an exemplary embodiment of the present disclosure. The wearable pump 298A is similar to the drug pump 200A described above with reference to Figure 2H. The wearable pump 298A has an operating mechanism such as a knob 298B similar to the knob 290 in Figure 2H. Figure 2T is a schematic diagram of the wearable pump 298A attached to a part of the user's body. The wearable pump 298A may be attached to a part of the user's body via an adhesive (not shown). Alternatively, the wearable pump 298A may be attached to a part of the user's body via a strap (e.g., strap 296B).

[0053] Figure 2U is a schematic diagram of another wearable pump 299A according to an exemplary embodiment of the present disclosure. Wearable pump 299A is similar to wearable pumps 296A and / or wearable pumps 297A. Wearable pump 299A is connected to an injection tube 298B similar to the injection tube 210 described above. Wearable pump 299A has a cover 299C, which is similar to the cover 296D described above with reference to Figure 2P. As shown in Figure 2V, the injection tube 298B is detachable from wearable pump 299A and can be removed from wearable pump 299A when the wearable pump 299A is not in operation. As further shown in Figure 2V, wearable pump 299A is attachable to a user's body part. Wearable pump 299A may be attached to a user's body part via an adhesive (not shown). Alternatively, the wearable pump 299A may be attached to a part of the user's body via a strap (e.g., strap 296B).

[0054] In one embodiment, the injection lead body 110 and / or injection lead body 110A can be positioned approximately parallel to the nerve, thereby allowing the two stimulation methods to be positioned along the length of the nerve with a gap that does not interfere with each other. The method for achieving such a position will be described in detail later with reference to Figures 3A to 3F. In another embodiment, the injection lead body 110 is positioned within the nerve sheath of the nerve distributed at the surgical site. The method for achieving such a position will be described in detail later with reference to Figures 3H to 3M.

[0055] Figure 2W is a schematic diagram of a needle guide system 2003 according to an exemplary embodiment of the present disclosure. The needle guide system 2003 is used to position an injection lead body 2008 (similar to, for example, injection lead body 110 and / or injection lead body 110A) substantially parallel to a nerve, as described with reference to Figures 3A to 3F, and / or within the nerve sheath of the nerve, as described with reference to Figures 3H to 3M. The needle guide system 2003 has a needle guide base 2002 connected to a needle guide 2006. The needle guide 2006 is configured to receive the injection lead body 2008 and a needle 50A (similar to, for example, the aforementioned needle 50), as shown in Figure 2X. The needle guide base 2002 is positioned on the user's skin near the insertion point where the needle 50A is inserted into the user's body. As shown in Figures 2W and 2X, a needle guide cover 2004 is positioned on the needle guide 2006. The needle guide 2006 is rotatable about a first axis (for example, approximately parallel to the needle guide base 2002). Therefore, by rotating the needle guide 2006 about the first axis, the insertion angle of the needle 50A at the insertion point can be changed. For example, rotating the needle guide 2006 about the first axis changes the insertion angle from, for example, approximately 85 degrees to approximately 5 degrees. The insertion angle can be adjusted when the needle guide cover 2004 is not positioned on the needle guide 2006. When the needle guide cover 2004 is positioned on the needle guide 2006, the insertion angle is locked. Once the needle guide cover 2004 is positioned on the needle guide 2006 and the insertion angle is locked, the angle does not change even when the needle 50A and / or injection lead body 2008 are inserted into the insertion point (for example, not due to unintended movements). Therefore, the practitioner can lock the insertion angle, and once locked, the techniques described later with reference to Figures 3A to 3F and / or Figures 3H to 3M can be performed with one hand without the risk of the insertion angle changing. The insertion angle is determined based on the target position of the injection lead body 2008; for example, a first target position requires a first angle (e.g., 35 degrees), and a second target position requires a different second angle (e.g., 45 degrees).The target location is determined based on factors such as the nerve site or the body part to be treated (e.g., the shoulder, leg, ankle, etc.).

[0056] One or more drugs can induce a local anesthetic block in a vein near the drug delivery point (e.g., near exit port 118), thereby relieving pain. Alternatively or additionally, one or more drugs can also induce vasodilation of tissue, veins, and / or nerves (e.g., dilation of the vein to a diameter greater than approximately 3 mm), leading to AVF maturation. AVF maturation corresponds to the ability of the inflowing artery and vein to respond to the increased blood flow that occurs during arterial-vein anastomosis. Since the AVF maturation period is longer than the vasodilation period, a certain amount of drug may induce vasodilation in a first period and AVF maturation in a second period, the second period being longer than the first. Vasodilation and / or AVF maturation result in clinical benefits such as improved vein grafting, improved wound healing, and reduced infection rates, due to increased blood flow over at least a certain period. For example, draining the drug over approximately 5 days may promote a certain amount of healing. Therefore, the vasodilation and / or AVF maturation described herein can be used, for example, to aid in pain management, facilitate insertion or vein selection during procedures (e.g., vasodilation allows for the selection of larger or more suitable veins, improving acute outcomes), and increase blood flow. In one embodiment, chronic wound healing and / or chronic pain relief (e.g., complex regional pain syndrome (CRPS), dry gangrene, etc.) can be achieved by chemical stimulation with one or more agents.

[0057] In one embodiment, the amount, frequency, or duration of stimulation may be determined to achieve a certain amount of vasodilation and / or AVF maturation (e.g., arbitrary vasodilation and / or AVF maturation) rather than providing analgesia. For example, a first amount, frequency, and / or duration of chemical stimulation may result in vasodilation and / or AVF maturation, while a second, larger amount, frequency, and / or duration of chemical stimulation may provide analgesia in addition to vasodilation and / or AVF maturation.

[0058] As mentioned above, one or more drugs can be supplied via the drug pump 200 / 200A. One or more drugs include, but are not limited to, applicable anesthetics, ropivacaine, bupivacaine, marcaine, lidocaine, dextrose, etc. Specific drugs are selected based on whether or not they are conductive. The amount of drug discharged by the drug pump 200 / 200A varies depending on the target nerve, the tissue surrounding the target nerve, the type of drug, and / or the target chemical stimulus (anesthetic effect, vasodilation, AVF maturation, etc.). For example, when targeting the tibial nerve, approximately 5 cc is discharged (e.g., single dose, hourly, at predetermined intervals, per operation, etc.). In another example, when targeting a shoulder nerve, 5 cc is discharged per hour. In one embodiment, an initial first amount of drug is discharged at a first time point (e.g., first operation), and a second amount of drug is discharged at a subsequent second time point. As further described herein, one or more drugs may be dispensed as a bolus and / or based on pulse administration (e.g., 3-5 cc every 3-4 hours). Depending on the amount of drug and / or frequency of action, the corresponding results (e.g., approximately 6-8 hours of analgesia, approximately 8-10 hours of analgesia, approximately 10-12 hours of analgesia, duration and amount of vasodilation, duration and time of AVF maturation, etc., or a combination thereof) may be produced. The duration and / or frequency of dispensing one or more drugs may be determined based on the corresponding battery life of the battery supplying power to the drug pump 200 / 200A and / or external controller, as further described herein.

[0059] In one embodiment, a chemical or electrical stimulus is initiated, modified and / or updated based on user input, or initiated automatically. User input can be received via a user device (such as a mobile device, computer, or wearable device) and / or via an input component associated with any device or component described herein. For example, the user makes user input via a button or interface associated with the housing 140, drug pump 200, pulse generator 300, etc., or a combination thereof. Such user input may include commands to initiate, modify, or update a chemical or electrical stimulus, feedback on an existing chemical or electrical stimulus, an indicator of the user's pain (e.g., pain score), etc.

[0060] Chemical and / or electrical stimuli are adjusted in response to user input. For example, chemical and / or electrical stimuli may be administered in response to user input to improve suitability for user-entered data. In this example, while user input is being administered, chemical and / or electrical stimuli are triggered based on any user input. For example, one or more characteristics of the chemical and / or electrical stimuli described herein (e.g., amount, frequency, duration, etc.) may or may not be determined based on user input. However, chemical and / or electrical stimuli may be withheld until user input is received. In one embodiment, chemical and / or electrical stimuli are adjusted in response to specific user input based on a particular treatment. For example, it may be necessary to receive a pain score before administering a bolus drug (e.g., auto-administration). In another example, an updated pain score may be required to manage continuous drug administration (e.g., basal administration).

[0061] Automated stimulation can be triggered based on events, algorithmic outputs, or machine learning outputs. Event-based triggers can be based on user-indicated pain, for example, based on detected impedance changes. For example, one or more impedance sensors are placed in contact with a vein, nerve, or tissue to generate impedance signals. Based on the impedance signals, if an impedance greater than a threshold impedance is detected, an event-based trigger will initiate automated stimulation (chemical and / or electrical stimulation, etc.). Algorithmic outputs are generated based on one or more inputs (e.g., user input indicating pain or the amount of pain, detected impedance, etc.), and based on the input to the algorithm, the amount, frequency, and / or duration of chemical or electrical stimulation are triggered. Machine learning outputs are described in more detail below.

[0062] To avoid the possibility of interference between the anesthetic solution and the stimulus (due to dispersion of the electric field by the anesthetic solution or blockade of sodium-potassium receptors in nerve cells or neurons), when two nerve block methods are performed simultaneously or in close succession, the exit port 118 and electrode 112 are positioned spaced apart along the length of the injection lead body 110. To maintain the effects of chemical and electrical stimulation identical or similar, the injection lead body 110 is positioned approximately parallel to the nerve as shown in the figure, thereby positioning the two stimulation modes spaced apart along the length of the nerve so as not to interfere with each other. Methods for achieving such positions are described with reference to Figures 3A to 3F. However, other methods may be employed, such as alternating the supply of chemical and electrical stimulation over time, for example, electrical stimulation may be performed after the anesthetic solution has roughly diffused. For example, electrical stimulation may be given during the day and chemical stimulation at night. This method is effective because chemical stimulation may interfere with motor function, while electrical stimulation does not. This allows the patient to receive physiotherapy during the day without impairing motor function.

[0063] Figures 3A to 3F schematically show an example of a method for positioning the injection lead body 110 approximately parallel to the nerve for the reasons described above. The exemplary method shown in Figures 3A to 3F can be carried out using the needle guide system 2003 of Figures 2W and 2X. Embodiments of this method are similar to methods for administering local anesthetics to achieve nerve block, i.e., using a needle of appropriate size 50 (e.g., a subcutaneous injection needle) under ultrasound guidance. Although ultrasound guidance is generally described herein, any applicable guidance method (e.g., radar, optical devices, sensors, etc.) may be used as an alternative or additional method to ultrasound guidance. The needle 50 has a proximal hub and a tip (e.g., a sharp tip). The needle 50 is long enough to penetrate the injection lead body 110 through the gasket 146 in the housing 140, and the tip of the needle 50 protrudes from the tip of the injection lead body 110. The needle 50 is considerably more rigid than the injection lead body 110 and maintains a linear configuration until removed. The diameter of the needle 50 is selected to approximately match the inner diameter of the injection lead body 110. This prevents the formation of large gaps that could hinder insertion into the skin, while also allowing for free movement.

[0064] Ultrasound guidance can be used to locate the nerve (N) and / or the peripheral vein (V) or artery adjacent to the peripheral nerve (N). The injection lead assembly 100 can be pre-attached to the needle 50 such that the needle 50 extends from the tip of the injection lead body 110 through a gasket 146 in the housing 140. In one embodiment, the injection lead assembly 100 is pre-attached to the needle 50 by activating or deactivating buttons 280A and 280B. While continuing ultrasound guidance, the needle 50 and the pre-attached injection lead assembly 100 are inserted through the skin (S) as shown in Figure 3A, positioning the tip of the needle 50 near the nerve (N). As shown in Figures 3B and 3C, the hub of the needle 50 is pushed toward the skin (S) without advancing the needle 50, orienting the assembly 100 to a position approximately parallel to the nerve (N). In this step, the nerve (N) and surrounding tissue are moved in the opposite direction to the pushing force, rather than cutting the tissue. With the injection lead body 110 extending substantially parallel to the nerve, the needle 50 and injection lead assembly 100 are advanced while maintaining ultrasound guidance to avoid nerve (N) damage and vein (V) puncture, as shown in Figure 3D. In one embodiment, the injection lead body 110 is advanced beyond the tip of the needle 50 without substantially moving the needle 50. Thus, the tip portion of the injection lead body 110 can extend beyond the tip of the needle 50, while the needle 50 surrounds the adjacent portion of the injection lead body 110. Once the injection lead assembly 100 has fully advanced and the adhesive patch 160 has made contact with the skin (S), the needle 50 is removed from the injection lead assembly 100 after the backing paper of the adhesive patch 160 is peeled off, as shown in Figure 3E. In one embodiment, buttons 280A and 280B are activated or deactivated in order to remove the needle 50 from the injection lead assembly 100. When the needle 50 is removed, the nerve (N) and surrounding tissue relax to a resting state due to the flexibility of the injection lead body 110 and the absence of the rigid needle 50.As a result, as shown in Figure 3F, a curved portion is formed at the proximal end of the injection lead body 110, and a relatively straight portion of the injection lead body 110 extends approximately parallel to the nerve (N). Movement is suppressed by the adhesive patch 160 that fixes the housing 140 to the skin directly above the insertion site.

[0065] In one embodiment, the injection lead body 110 is positioned within the nerve sheath of a nerve distributed at the surgical site. The nerve sheath is a layer of myelin and / or connective tissue that surrounds and isolates nerve fibers. Figure 3G schematically shows the injection lead body 110 positioned approximately parallel to the nerve, with the tip of the injection lead body 110 positioned within the nerve sheath. As shown in the figure, when inserted into and / or adhered to the epidermis (skin) and inserted into the sheath, the injection lead body 110 has a length that allows the tip electrode 112 and the exit port 118 to be positioned near the nerve distributed at the surgical site. By positioning it in this way, a drug (e.g., anesthetic solution) can be delivered to the nerve from the drug pump 200 via the exit port 118, and electrical stimulation can be delivered to the nerve from the pulse generator 300 via the electrode 112, thereby combining chemical and electrical nerve block effects. A cover (e.g., a cover with a valve, slit, etc.) may be placed over the exit port 118 to suppress or prevent occlusion of the exit port 118. The cover may be made of silicone or may contain bioabsorbable or biodegradable material. The cover may be placed on the outer surface of the outlet port 118 or on the inner surface of the outlet port 118 (for example, inside the injection lead body 110).

[0066] A method for achieving such a position will be described with reference to Figures 3H to 3M. The exemplary method shown in Figures 3H to 3M can be carried out using the needle guide system 2003 of Figures 2W and 2X. Embodiments of this method are similar to those described in Figures 3A to 3F. Ultrasound guidance is used to locate the nerve, nerve sheath and / or peripheral vein or artery near the peripheral nerve. The injection lead assembly 100 can be pre-attached to the needle 50 such that the needle 50 extends from the tip of the injection lead body 110 through a gasket 146 (not shown) in the housing 140. In one embodiment, the injection lead assembly 100 is pre-attached to the needle 50 by setting buttons 280A and 280B to the activated or deactivated state. While continuing ultrasound guidance, the needle 50 and the pre-attached injection lead assembly 100 are inserted through the skin as shown in Figure 3H until the tip of the needle 50 penetrates the sheath. As shown in Figure 3I, the tip of the injection lead body 110 also penetrates the sheath by passing through the opening formed by the tip of the needle 50 that has perforated the sheath. As shown in Figures 3I and 3J, the hub of the needle 50 is pushed toward the skin without significantly advancing the needle 50, allowing the assembly 100 to be positioned approximately parallel to the nerve with the tip of the needle 50 and the tip of the injection lead body 110 between the sheath and the nerve. In this step, the nerve and surrounding material (tissue, sheath material, etc.) move in the opposite direction to the pushing force. As shown in Figures 3I to 3L, the hub of the needle 50 is pulled away from the injection lead body 110 while the injection lead body 110 is further pushed into the sheath. In this way, the tip of the injection lead body 110 can be inserted into the sheath without inserting the needle 50 into the sheath, reducing the risk of the needle 50 perforating or damaging a vein or nerve. In one embodiment, the needle 50 is pulled away from the injection lead body 110 by activating or deactivating buttons 280A and 280B. As shown in Figure 3K, the tip of the injection lead body 110 is positioned between the sheath and the nerve, and with the injection lead body 110 extending approximately parallel to the nerve, the injection lead assembly 100 is advanced while maintaining ultrasound guidance to avoid nerve damage and vein perforation.Once the injection lead assembly 100 has fully advanced and the adhesive patch 160 has made contact with the skin, the needle 50 is completely removed from the injection lead assembly 100 after the backing paper of the adhesive patch 160 is peeled off, as shown in Figure 3L. Upon removal of the needle 50, the nerve, nerve sheath, and surrounding tissue relax to a resting state due to the flexibility of the injection lead body 110 and the absence of the rigid needle 50. As a result, a curved portion is formed at the proximal end of the injection lead body 110, and a relatively straight portion extends approximately parallel to the nerve. As shown in Figure 3M, the placement of the electrode 112 and exit port 118 within the sheath allows for the delivery of a drug (such as an anesthetic solution) from the drug pump 200 to the nerve via the port 118 within the sheath, and electrical stimulation from the pulse generator 300 to the nerve via the electrode 112 within the sheath. This provides a combination of chemical and electrical nerve block effects. As shown in Figure 3M, the adhesive patch 160 secures the housing 140 to the skin directly above the insertion site to prevent movement.

[0067] In one embodiment, as shown in Figure 3H, a slit may be formed in the sheath by perforation or the like before inserting the needle 50 and the pre-attached injection lead assembly 100 into the skin and sheath. The sheath can be slit by perforation or the like using applicable techniques such as cutting instruments used to perform perforation or cutting under ultrasound guidance. Therefore, instead of perforating the sheath with the tip of the needle in Figure 3H, the needle 50 and the pre-attached injection lead assembly 100 can be inserted through the skin and the pre-perforated or cut sheath.

[0068] In one embodiment, as shown in Figure 3M, the electrode 112 and the outlet port 118 are positioned close to each other so that both the electrode 112 and the outlet port 118 are located within the sheath. In this embodiment, the amount of fluid (e.g., drug) delivered through the outlet port 118 may be less than when the outlet port 118 is located outside the sheath. Furthermore, in this embodiment, the size of the outlet port 118 may be smaller than when the outlet port 118 is located outside the sheath.

[0069] In one embodiment, the tip of the infusion lead body 110 is positioned such that the electrode 112 is located inside the sheath and the exit port 118 remains outside the sheath. In this embodiment as well, as described above, the infusion lead body 110 can be positioned approximately parallel to the nerve. Electrical stimulation is sent from the pulse generator 300 to the nerve via the electrode 112 inside the sheath, while the drug sent from the drug pump 200 to the nerve is sent to the outside of the sheath.

[0070] For subchronic (e.g., less than approximately 60 days) or chronic (e.g., more than approximately 60 days) pain management, all or part of the infusion lead assembly 100, drug pump 200, and pulse generator 300 can be implanted subcutaneously. For example, as shown in Figure 4A, an implantable pulse generator (IPG) 400 implanted subcutaneously can be used instead of the housing 140. Alternatively, as shown in Figure 4B, a combination of a subcutaneously implanted receiver (RX) module 500 and a wirelessly linked transmitter (TX) module 550 (connected to an external pulse generator (EPG)) can be used instead of the housing 140. The safety mechanisms described herein may be included in or associated with the RX module 500 and / or the TX module 550. The safety mechanisms are configured to prevent accidental and / or excessive chemical and / or electrical stimulation according to the methods described herein. For example, the safety mechanism may generate a signal that prevents electrical stimulation for a certain period in response to the administration of electrical stimulation. After a certain period of time, the RX module 500, TX module 550, and / or safety mechanism generate a release signal, allowing for additional electrical stimulation. To facilitate the injection of an anesthetic via a needle 60 (e.g., a subcutaneous injection needle), a subcutaneous injection port 70 including a sealing gasket and lumen can be incorporated into the IPG 400 or RX module 500. In the embodiment of Figure 4B, the RX module 500 has a receiving antenna (e.g., a coil) and / or any applicable inductive component, and the stimulation signal is generated by an external pulse generator 300 and received wirelessly (RF or inductively, etc.) from the external pulse generator 300. Alternatively, the RX module 500 may have a stimulation circuit and a receiving antenna (e.g., a coil), and may be configured to receive power from the TX module 550 via a wireless link (RF or inductively, etc.) and generate the stimulation signal.

[0071] In the embodiments described herein, the subcutaneously placed components (except for the IPG400, which contains a battery) consist of bioabsorbable or biodegradable polymers (e.g., the injection lead body 110) and / or bioabsorbable or biodegradable metals (e.g., electrodes 112, RX module 500, etc.). Such polymers and metals are described in the Nature Biotechnology (2021) paper by Choi et al. entitled “Fully implantable and bioresorbable cardiac pacemakers without leads or batteries,” the full disclosure of which is incorporated herein by reference. Other examples of biodegradable polymers include polyglycolides or polyglycolic acid (PGA), poly-L-lactic acid (PLLA), poly-3-hydroxybutyric acid (PHB), polycaprolactone (PCL), etc., or combinations thereof. Electrodes 112 and / or 114 are wirelessly powered and controllable from outside the patient’s body, as described herein. Electrodes 112 and / or 114 can transmit electrical signals of up to approximately 30V to 60V. The electrical signals transmitted through electrodes 112 and / or 114 are pulse trains with a constant pulse width, frequency (e.g., approximately 50kHz to 40kHz), and amplitude (e.g., approximately 0 to 15Vpp). In one embodiment, the amplitude and / or frequency can be adjusted by patient input via an external pulse generator 300 and / or an external controller. For example, the patient can input amplitude and frequency, or select amplitude and frequency from two or more pre-programmed amplitudes and frequencies.

[0072] Table 1 shows exemplary electrical parameters that may be output or applied by one or more electrical components described herein, such as the electric pulse generator 300, IPG400, RX module 500, TX module 550, electrode 112 and / or electrode 114.

[0073] [Table 1]

[0074] Bioabsorbable and / or biodegradable materials conduct energy until a threshold amount of decomposition occurs, after which energy conduction may be limited or fall below a predetermined threshold (e.g., a usable threshold). Biodegradable materials may also decompose in stages. For example, the first stage is a first number of days (e.g., 5-12 days), during which energy conduction (e.g., via electrodes) decreases to the first conduction stage. Biodegradable materials may decompose to one or more second stages (e.g., 12-20 days, 12-40 days, 40-60 days, etc.), during which energy conduction decreases to one or more second-state stages or ceases altogether. Non-biodegradable materials can also be used to insert and / or position biodegradable materials.

[0075] The decomposition of biodegradable materials is accelerated or decelerated based on one or more of the following: the selected material and / or the amount of material, the application of a decomposition catalyst (e.g., the amount or type of catalyst), the location of the biodegradable material within the body, etc. A receiving antenna (e.g., the antenna of the RX module 500) receives radio transmissions in a certain frequency range. When a radio transmission is received in a specific frequency range, energy is generated at the electrodes (e.g., based on the resonance of the receiving antenna).

[0076] The distance between the transmitting coil and the receiving antenna can be determined based on the length of time the biodegradable material is present in the body (for example, the longer the time, the shorter the required distance). A control device (mobile device, external device, etc.) is used to control an external device (TX module 550, etc.) placed on or near the user's skin (via a patch, etc.) via a wired or wireless connection. The control device causes the transmitting coil to output a wireless pacing signal. The control device may determine the characteristics of the wireless pacing signal based on one or more of the following: electrode position, user attributes (level of pain, level of medication consumed (opioid, etc.), type of medication consumed, type of stimulation (nerve stimulation, etc.), time elapsed since previous stimulation and / or medication consumption, pattern of past stimulation and / or medication consumption, etc.).

[0077] For example, biodegradable electrodes can be inserted into a patient's body to supply an electric current to a part of the patient's nervous system (such as the spinal cord). The patient can input the level of pain they are experiencing during the procedure. A control device may determine a pacing signal output by a wireless pacing device so that the electrodes resonate and stimulate a region of the spinal cord, reducing the pain felt by the user. Such stimulation can be used as an alternative to or in addition to medication (such as analgesics).

[0078] Figures 5A to 5C schematically illustrate an alternative multimodal pain management system. In this embodiment, the alternative system has a module 170 connected to the infusion lead body 110 as described above. The module 170 has a housing 172, a fluid line connector 174 (e.g., a toybost), and a female electrical receptacle 176, which is optionally sealed with a removable silicone rubber plug or the like. The fluid line connector 174 has an in-line filter to reduce the entry of bacteria and pathogens and has a sealing diaphragm. The fluid line connector 174 is detachably attached to the drug pump 200 via a tube 210, providing communication between the drug pump 200 and the nerve (N) via the infusion lead body 110 as described above. Similarly, the female electrical receptacle 176 is detachably connected to a male jack 178 and cable 310 and electrically connected to an external pulse generator 300, providing electrical conduction between the pulse generator 300 and the nerve via the infusion lead body 110 and associated electrodes as described above. Module 170 and injection lead body 110 are covered with adhesive patches attached to the skin (S) to secure the system in place. The alternative multimodal pain management systems shown in Figures 5A–5C can be inserted near nerves by the method described with reference to Figures 3A–3M.

[0079] The drug pump 200 may be, for example, an electromechanical pump (e.g., a motor-controlled piston in a chamber) or a mechanical pump (e.g., a syringe type or valve operated by a spring or manually). As shown in Figure 5B, the drug pump 200 has a simple user interface that allows only a prescribed amount of drug (such as an anesthetic) to be administered to the patient, and the drug can be administered in individual boluses of controlled amounts, such as three boluses of approximately 5cc to 10cc each, or one or more boluses of 50cc to 100cc per day. Each bolus is activated, for example, by the user pressing a button 220, and the drug can be administered as needed (e.g., according to perceived pain). Other buttons may be locked for a certain period of time to prevent multiple boluses from being administered simultaneously. The external pulse generator 300 also has a simplified user interface, and the patient can select from a limited number of prescribed pulse therapies (prescribed frequencies and amplitudes, etc.) using up / down, select, and start buttons 320 and a display screen 330.

[0080] The drug pump 200 enables periodic basal administration of a prescribed amount of medication (e.g., an anesthetic) over a set period (e.g., daytime, nighttime, continuous). Basal administration can be activated by the user via the interface of the drug pump 200 or an external controller, as further described herein. Basal administration may be performed according to one or more pre-programmed basal administration settings, which are entered by the user or stored in the drug pump 200 or an external controller. Basal administration settings are user-adjustable or adjustable via signals received by the drug pump 200 or an external controller. The drug pump 200 can enable the delivery of a bolus dose based on patient activity. The patient can activate the delivery of a bolus dose via the drug pump 200 and / or an external controller by making patient inputs. For example, the drug pump 200 may be programmed to supply a basal dose at a constant or variable level. Furthermore, the patient can activate the delivery of a bolus dose by making patient inputs, and this dose may be greater than the basal dose.

[0081] In one embodiment, the drug pump 200 and / or the external pulse generator 300 communicate with an external controller (e.g., a mobile device, a standalone device, etc.). Such communication may be wired or wireless. In this embodiment, the drug pump 200 may not have the button 220, or it may have a subset of the button 220. Similarly, the external pulse generator 300 may not have the button 320, or it may have a subset of the button 320. The external controller has an interface (graphical interface, physical interface, etc.) that provides selectable components (buttons, icons, etc.). When such selectable components are selected, the external controller transmits one or more signals. The signals are received by a receiver that is conductive with the drug pump 200 and / or the external pulse generator 300. One or more signals cause the drug pump 200 and / or external pulse generator 300 to perform the operations disclosed herein (e.g., activating the drug pump 200 and / or pulse generator 300, causing the drug pump 200 to output a certain amount of fluid, causing the pulse generator 300 to output an electrical signal, etc.). For example, the external controller has a simple user interface that allows only a predetermined amount of drug (such as an anesthetic) to be administered to the patient, based on the user selecting a corresponding selectable component.

[0082] The external controller has code, scripts, etc., that cause the external controller processor to generate one or more signals. The one or more signals are generated based on user input, which involves selecting one or more selectable components (buttons, icons, etc.), and / or based on programmed instructions. For example, the external controller may be a mobile device equipped with components (transmitters, etc.) for transmitting one or more signals wirelessly (e.g., via BLUETOOTH®, infrared, WiFi, local area network, wide area network, etc.). The application or interface can be accessed using the mobile device (web application, mobile application, etc.), and the application can receive user input (inputs to activate the drug pump 200 and / or external pulse generator 300, inputs to change the dosage or frequency of drug administration, inputs to activate electrical activity, etc.) through one or more selectable components of the application. The application transmits one or more signals to the mobile device based on the selected selectable component. The transmitted signals are received by the drug pump 200 and / or external pulse generator 300, causing the drug pump 200 and / or external pulse generator 300 to perform an action.

[0083] The external controller is programmable to generate one or more signals based on pre-programmed settings. Such settings allow the external controller to automatically send one or more signals based on a trigger. This trigger may be time, duration, sensor input, external signal, or a combination thereof.

[0084] In one embodiment, chemical and / or electrical stimuli are controlled by the machine learning output of a machine learning model. The machine learning model is trained on actual and / or simulated inputs and corresponding actual and / or simulated chemical and / or electrical stimuli. Inputs include, but are not limited to, treatment characteristics (e.g., type of procedure, type or severity of injury or symptom), user characteristics (e.g., user statistics, user weight, user biological characteristics, user pain threshold), analgesia, vasodilation (e.g., amount of vasodilation), AVF maturation (e.g., amount of AVF maturation), impedance, etc. The machine learning model may be trained by modifying one or more weights, layers, synapses, nodes, etc. of the machine model based on a machine learning algorithm, as further disclosed herein.

[0085] A trained machine learning model receives a current input associated with a user and generates one or more outputs based on that input. For example, the machine learning model may receive therapeutic properties, user properties, analgesic properties, current or expected vasodilation information, current or expected AVF maturation information, and / or impedance values. Current inputs can be based on user input or on one or more sensors configured to detect the current input, respectively. Based on the current input, the machine learning model outputs properties of the chemical or electrical stimulation, such as the amount, frequency, and / or duration of the chemical or electrical stimulation. The outputs are based on a target time (e.g., target end time for the electrical or chemical stimulation), a trend (e.g., decrease in the electrical or chemical stimulation over time), and / or a target electrical or chemical stimulation. The outputs of the algorithms and / or machine learning described herein can facilitate a closed-loop system in which electrical and / or chemical stimulation and associated properties (e.g., frequency, amount, duration, etc.) can be automatically determined based on the outputs of the algorithms and / or machine learning. For example, electrical and / or chemical stimulation can be output based on an algorithm and / or machine learning output schema that is adjustable based on user input (e.g., pain score). Electrical and / or chemical stimuli can be adjusted according to algorithms and / or machine learning output schemas based on trend analysis, for example, allowing for weaning from electrical and / or chemical stimuli over time (e.g., based on the user's response to the stimulation). Weaning involves reducing the electrical and / or chemical stimuli without the user experiencing adverse effects such as increased pain. The characteristics of the chemical or electrical stimuli are provided to an external controller, which is configured to activate pump 200 / 200A and / or pulse generator 300 based on the characteristics of the chemical or electrical stimuli. A machine learning model can be configured to provide updated characteristics of the chemical or electrical stimuli based on the updated current input.

[0086] Figure 6 is a flowchart 600 of multimodal electrical and chemical stimulation according to an embodiment disclosed herein. In step 602, an electrical signal is received at a connector (e.g., connector 150). The electrical signal is received from a pulse generator (e.g., pulse generator 300) and generated by the pulse generator based on user input or pre-programmed settings, etc. In step 604, one or more signals, or signals generated based on the electrical signal, are transmitted through an electrical path to the internal lead body tip electrode (e.g., tip electrode 112) via the connector conductive trace, connector metal pin, housing pin receptacle (e.g., pin receptacle of housing 140), housing conductive trace (e.g., conductive trace of housing 140) and / or internal wires of the injection lead body (e.g., internal wires of injection lead body 110).

[0087] In step 606, the fluid is received at the connector. The fluid is received from a pump (e.g., pump 200) and is a drug, other chemical, or fluid. The fluid is received based on user input, pre-programmed settings, etc. In step 608, the fluid flows through the fluid path via the connector internal lumen, connector needle, housing needle receptacle (e.g., needle receptacle of housing 140), housing lumen (e.g., lumen of housing 140) and / or injection lead body injection lumen (e.g., injection lumen of injection lead body 110) to the injection lead body outlet port (e.g., outlet port 118).

[0088] The technique described in flowchart 600 can be used to provide the user with both electrical and chemical stimulation. The electrical signal transmitted through the tip electrode in step 604 provides electrical stimulation based on one or more electrical signal characteristics (e.g., frequency, amplitude, frequency or amplitude change, phase, duration, etc.). The fluid delivered through the outlet port in step 608 provides chemical stimulation based on the chemical properties of the delivered fluid.

[0089] Figure 7 is a flowchart 700 relating to the arrangement of an injection lead body according to an embodiment disclosed herein. In step 702, an injection lead assembly (e.g., injection lead assembly 100) is mounted on a needle (e.g., needle 50). The needle has a needle tip at a first end and a needle hub at a second end opposite the first end. The injection lead assembly can be mounted on the needle by passing the needle tip through a gasket (e.g., gasket 146) or another opening in the injection lead assembly housing (e.g., housing 140). The needle tip can advance within the injection lead body by passing through the tip of the injection lead body (e.g., injection lead body 110) of the injection lead assembly.

[0090] In step 704, as shown in Figure 3A, the injection lead assembly attached to the needle is inserted through the user's skin. The needle punctures the user's skin, and the injection lead assembly attached to the needle advances through the opening created by the needle puncturing the user's skin. In step 706, as shown in Figures 3A-3C, the needle hub is positioned toward the user's skin by applying force (e.g., on the proximal portion of the needle hub and / or injection lead assembly). The force in step 706 is applied until the injection lead assembly attached to the needle is approximately parallel to the nerve, as shown in Figure 3C.

[0091] In step 708, as shown in Figure 3D, force is applied to the needle hub, causing the injection lead assembly attached to the needle to advance further into the user's body. The force applied in step 708 is such that the injection lead assembly attached to the needle advances further into the user's body while maintaining a position approximately parallel to the vein. In step 710, as shown in Figure 3E, the needle is removed from the injection lead assembly. The needle can be removed by pulling it back from the injection lead assembly, allowing the needle tip to pass through the injection lead assembly and exit from the proximal end of the injection lead assembly. As shown in Figure 3F, after the needle is removed from the injection lead assembly, the injection lead body of the injection lead assembly (e.g., injection lead body 110) remains in the user's body. The injection lead body is maintained approximately parallel to the user's vein. The steps shown in Figures 3A to 3F can be performed with one hand. For example, in step 702, the injection lead assembly attached to the needle can be inserted through the user's skin with one hand. In another example, the force applied in step 708 can be applied with one hand. For this reason, the injection assembly and / or needle may have a grippable material and / or shape so that the steps shown in Figures 3A to 3F can be performed with one hand.

[0092] Figure 8A is a schematic diagram of an electron configuration detector 802 according to an exemplary embodiment of the present disclosure. The electron configuration detector 802 is connected to a configuration connector 806 via a wire 804. The configuration connector 806 has one or more conductive traces. The conductive traces in the configuration connector 806 are connected to conductive traces 145 in the housing 140, thereby providing conductivity between the electron configuration detector 802 and electrodes 112, 114. During the insertion of the injection lead body 110 (e.g., Figures 3A to 3M) and / or after the injection lead body 110 has been placed in the patient's body, the electron configuration detector 802 is connected to the housing 140 via the wire 804 and the configuration connector 806.

[0093] The electron placement detector 802 generates a low-voltage electronic signal that is transmitted to electrodes 112 and / or 114 via an electrical path formed by the electron placement detector 802, wire 804, placement connector 806, conductive trace 145 within the housing 140, and internal wires of the injection lead body 110. The patient and / or healthcare provider activate the electron placement detector 802 to generate a low-voltage electronic signal, which is output via electrodes 112 and / or 114. Whether the injection lead body 110 is positioned near a nerve can be confirmed by the patient reporting their sensation to the low-voltage electronic signal. Alternatively or additionally, the low-voltage electronic signal can elicit a motor response, and based on the observed motor response, it can be confirmed that the injection lead body 110 is positioned close to a nerve.

[0094] Figure 8B is a schematic diagram of the visual placement detector 808. The visual placement detector 808 is attached to the placement connector 806 via a fluid channel 810. As shown in Figure 8B, the connection of the visual placement detector 808 to the infusion lead body 110 may be made simultaneously with the connection of the electronic placement detector 802 to the infusion lead body 110. Alternatively, either the visual placement detector 808 or the electronic placement detector 802 may be connected to the insertion portion of the infusion lead body 110 at a specific point in time. The placement connector 806 has a fluid channel. The fluid channel of the placement connector 806 is connected to the lumen 144 of the housing 140, communicating the visual placement detector 808 with the outlet port 118. During the insertion of the infusion lead body 110 (e.g., Figures 3A to 3M), and / or after the infusion lead body 110 has been placed in the patient's body, the visual placement detector 808 is connected to the housing 140 via the fluid channel 810 and the placement connector 806.

[0095] The visual placement detector 808 may include a chamber or be connected to a chamber containing a detection medium. The detection medium is any applicable fluid (e.g., saline solution) or gas (e.g., air) that can be injected into the patient's body via the outlet port 118. The visual placement detector 808 can deliver the detection medium to the outlet port 118 via a fluid path formed by the visual placement detector 808, the fluid channel 810, the placement connector 806, the lumen 144 in the housing 140, and the injection lumen of the injection lead body 110. The patient and / or healthcare provider activate the visual placement detector 808 to deliver the detection medium via the outlet port 118. Whether the injection lead body 110 is positioned near a nerve can be confirmed by visually (e.g., by ultrasound) observing the position of the detection medium exiting the outlet port 118 and comparing the position of the detection medium to the position of a specific nerve.

[0096] Figure 9 shows another schematic diagram of the multimodal system. This system generally has an infusion lead assembly 100 configured to be releasably connected to a drug pump 200 (Figure 1A), a pulse generator 300 (Figure 1B), or a combined drug pump and pulse generator 200 / 300 (Figure 1C) via a housing 140, a connector 150, and corresponding infusion tubes and cables. The housing 140 is fixed to the epidermis via an adhesive patch 160 to prevent movement. The top of the adhesive patch 160 is attached (e.g., permanently) to the underside of the housing 140. The bottom of the patch 160 has an adhesive layer (e.g., suitable for use for about 10-14 days in a normal living environment), which is covered with a removable covering (e.g., removable wax paper) until it is ready to be attached to the epidermis.

[0097] The infusion lead assembly 100 has a tubular infusion lead body 110 whose proximal end is connected to a housing 140. An infusion lumen (not shown) extends inside the infusion lead body 110, and an outlet port 118 (shown in Figure 1A) and a drug pump 200 are in communication via the housing 140, a connector 150, and an infusion tube (for example, if the connector 150 is connected to the housing 140). The infusion lead body 110 may further have one or more proximal electrodes 112 (shown in Figure 1A) and one or more proximal electrodes 114 (shown in Figure 1A) that are in electrical contact with the pulse generator 300 via a wire (not shown) embedded in the wall of the infusion lead body 110, an internal wire (not shown) extending through the housing 140 and the connector 150, and a cable. The internal wire embedded in the wall of the infusion lead body 110 extends along at least a portion of the infusion lumen of the infusion lead body 110.

[0098] As previously stated, one or more embodiments disclosed herein can be implemented using machine learning models. The machine learning models disclosed herein can be trained using the systems, components, methods, etc., related to Figures 1 to 9 above. As shown in the flowchart 1010 of Figure 10, the training data 1012 includes one or more stage inputs 1014 and known results 1018 related to the machine learning model to be trained. The stage inputs 1014 can be obtained from any applicable source, including the components or sets shown in Figures 1 to 9. The known results 1018 are included in machine learning models generated based on supervised or semi-supervised training. Unsupervised machine learning models are not trained using the known results 1018. The known results 1018 may include known or desired outputs for future inputs that are similar to or in the same category as stage inputs 1014 for which there are no corresponding known outputs.

[0099] The training data 1012 and the training algorithm 1020 are provided to the training component 1030, which applies the training data 1012 to the training algorithm 1020 to generate a trained machine learning model 1050. In one embodiment, the training component 1030 is provided with comparison results 1016, which compare the previous output of the corresponding machine learning model and retrain the machine learning model by applying the previous results. The training component 1030 can update the corresponding machine learning model using the comparison results 1016. The training algorithm 1020 can utilize, but is not limited to, deep learning networks such as deep neural networks (DNNs), convolutional neural networks (CNNs), fully convolutional networks (FCNs), and recurrent neural networks (RCNs), probabilistic models such as Bayesian networks and graphical models, and / or discriminative models such as decision forests and maximum margin methods. The output of flowchart 1010 is the trained machine learning model 1050.

[0100] Generally, processes or operations disclosed herein (such as those described with reference to Figures 1 to 10) that are understood to be executable by a computer can be executed by one or more processors in a computer system. A process or process step executed by one or more processors may also be referred to as an operation. One or more processors can be configured to execute such processes by accessing instructions (such as software or computer-readable code) that, when executed by one or more processors, cause one or more processors to execute a process. Instructions can be stored in the memory of the computer system. Processors are central processing units (CPUs), graphics processing units (GPUs), or any suitable type of processing unit.

[0101] In one embodiment disclosed herein, means for collecting, storing and / or transmitting drug delivery data can be embodied using one or more processors of a computer system. Drug delivery data may include, but is not limited to, any data described herein, such as, for example, the data described with reference to Figures 1 to 10, bolus volume, bolus time, basal dose, basal time, chemical stimuli properties (e.g., time, volume, frequency, etc.), electrical stimuli properties (e.g., time, volume, frequency, etc.), and / or data associated with one or more of the same, or a combination thereof. The means may include collecting, recording and / or transmitting drug delivery data via wired or wireless communication, or collecting, recording and / or transmitting the data to a server, database, memory, cloud component, and / or component disclosed with reference to Figure 11.

[0102] A computer system, such as a system or device that embodies the process or operation of the above example, may include one or more arithmetic units, such as one or more systems or devices disclosed in or in connection with Figures 1 to 10. One or more processors in a computer system may be included in a single arithmetic unit or distributed among multiple arithmetic units. The memory of a computer system may include the memory of each of the multiple arithmetic units.

[0103] Figure 11 is a simplified functional block diagram of a computer 1100 configured as an apparatus for performing the systems and / or techniques of Figures 1 to 10, according to an exemplary embodiment of the present disclosure. For example, the computer 1100 is configured as a system according to an exemplary embodiment of the present disclosure. In various embodiments, any system described herein may be a computer 1100 including, for example, a data communication interface 1120 for packet data communication. The computer 1100 has a central processing unit (CPU) 1102 as one or more processors for executing program instructions. The computer 1100 has an internal communication bus 1108 and a storage unit 1106 (ROM, HDD, SSD, etc.) capable of storing data in a computer-readable medium 1122, although the computer 1100 may receive programs and data via network communication. The computer 1100 also has memory 1104 (such as RAM) for storing instructions 1124 for performing the techniques described herein, although the instructions 1124 may be stored temporarily or permanently in other modules of the computer 1100 (e.g., a processor 1102 and / or a computer-readable medium 1122). The computer 1100 also has input / output ports 1112 and / or a display 1110 for connecting to input / output devices such as a keyboard, mouse, touchscreen, monitor, and display. To distribute the processing load, various system functions may be distributed and implemented on multiple similar platforms. Alternatively, the system may be implemented by appropriate programming on a single computer hardware platform.

[0104] The program aspects of this method can generally be understood as “products” or “manufactured goods” in the form of executable code and / or related data held or embedded in some kind of machine-readable medium. “Storage” media include some or all of the physical memory of computers, processors, etc., various semiconductor memories, tape drives, disk drives, and other related modules that can always provide non-temporary storage of software programs. All or part of the software is communicable via the Internet or various other communication networks 1190. Such communication enables, for example, the loading of software from any computer or processor to another computer or processor, for example, from a management server or host computer of a mobile communication network to a server's computer platform, or from a server to a mobile device. Other types of media capable of transmitting software elements include physical interfaces between local devices, wired and optical fixed-line networks, and various air links, such as optical waves, electrical waves, and electromagnetic waves. Physical elements that transmit the above waves, such as wired or wireless links and optical links, can also be considered media for holding software. In this specification, unless limited to non-temporary and tangible “storage” media, the terms such as “readable media” used by a computer or machine refer to any media involved in providing execution instructions to a processor.

[0105] Although the disclosed methods, apparatus, and systems are described using data transmission as an example, the disclosed embodiments are applicable to any environment, including desktop or laptop computers, automotive entertainment systems, and home entertainment systems. Furthermore, the disclosed embodiments are applicable to all types of Internet protocols.

[0106] In the above description of exemplary embodiments of the present invention, various features of the invention may be grouped into a single embodiment, figure, or description in order to simplify the disclosure and aid in understanding one or more of the various aspects of the invention. However, this method of disclosure should not be interpreted as reflecting an intention that the claimed invention requires more features than expressly described in each claim. Rather, as reflected in the following claims, aspects of the invention reside in fewer features than all of the features of the single embodiment described above. Accordingly, the claims following the detailed description are expressly incorporated into this detailed description, and each claim stands independently as a separate embodiment of the invention.

[0107] Furthermore, some embodiments described herein include some features included in other embodiments, but not others. Combinations of features from different embodiments are within the scope of the present invention and are intended to form different embodiments, as will be understood by those skilled in the art. For example, in the following claims, any combination of the claimed embodiments may be used.

[0108] Therefore, although specific embodiments have been described, those skilled in the art will recognize that other further modifications can be made without departing from the spirit of the invention. All such modifications and alterations fall within the scope of the invention. For example, functions may be added to or removed from the block diagram, or operations may be swapped between function blocks. Steps can be added to and removed from the described methods within the scope of the invention.

[0109] The subject matter disclosed above should be considered illustrative and not restrictive, and the accompanying claims are intended to encompass all such modifications, extensions, and other embodiments that fall within the true spirit and scope of this disclosure. Therefore, to the maximum extent permitted by law, the scope of this disclosure shall be determined by the broadest permissible interpretation of the following claims and their equivalents, and shall not be limited or restricted by the foregoing detailed description. While various embodiments of this disclosure have been described, it will be obvious to those skilled in the art that many more embodiments are possible within the scope of this disclosure. Therefore, this disclosure is not limited in view of the accompanying claims and their equivalents.

[0110] The subject matter disclosed herein relates, for example, to the following embodiments. 1. An injection lead assembly comprising: a housing having a needle receptacle, a housing lumen, a pin receptacle, and a housing conductive trace; a connector having a connector needle, an internal lumen, a metal pin, and a connector conductive trace; and an injection lead body having an injection lumen, an outlet port, an internal wire, and a tip electrode, wherein the injection lead assembly forms an electrical path for transmitting electrical signals across the connector conductive trace, the metal pin, the housing conductive trace, the internal wire, and the tip electrode; and the injection lead assembly forms a fluid path for transmitting fluid across the internal lumen, the connector needle, the injection lumen, and the outlet port.

[0111] 2. An injection lead assembly of Embodiment 1, wherein the housing further comprises a first gasket forming a fluid seal with a needle receptacle and a second gasket forming a fluid seal with a pin receptacle.

[0112] 3. An injection lead assembly of Embodiment 2, wherein at least one of the first gasket or the second gasket includes an inline filter. 4. An injection lead assembly of Embodiment 3, wherein the inline filter includes an antimicrobial material or antimicrobial coating.

[0113] 5. An injection lead assembly of Embodiment 1, wherein the housing further comprises a housing connector, the connector further comprises a connector connector, and the housing connector is molded to receive the connector connector.

[0114] 6. An injection lead assembly of Embodiment 1, wherein the housing further comprises a housing connector, and the connector further comprises a connector connector, the connector connector being molded to receive the housing connector.

[0115] 7. An injection lead assembly of Embodiment 1, wherein the housing lumen is configured to communicate with the injection lumen. 8. An injection lead assembly of Embodiment 1, wherein the housing lumen is configured to communicate with an injection lumen and an outlet port.

[0116] 9. An injection lead assembly of Embodiment 1, wherein the housing lumen is configured to communicate with a drug pump, a connector needle connected to the drug pump via an injection tube, an injection lumen, and an outlet port.

[0117] 10. An injection lead assembly of Embodiment 1, wherein the pin receptacle has an electrical surface for electrical contact with an internal wire. 11. An injection lead assembly of Embodiment 1, wherein the pin receptacle has an electrical surface for electrical contact with an internal wire and a tip-side electrode.

[0118] 12. An injection lead assembly of Embodiment 1, wherein the pin receptacle has an electrical surface for electrical contact with a pulse generator, a housing conductive trace, an internal wire, and a tip-side electrode.

[0119] 13. An injection lead assembly of Embodiment 1, further comprising a proximal electrode. 14. An injection lead assembly of Embodiment 13, wherein the proximal electrode functions as either a cathode, an anode, or effective ground.

[0120] 15. An injection lead assembly of Embodiment 1 further comprising a fastener. 16. An injection lead assembly of Embodiment 15, wherein the fastener is a cuff. 17. An injection lead assembly of Embodiment 16, wherein the fastener is composed of at least one of a bioabsorbable material or a biodegradable material.

[0121] 18. An injection lead assembly of Embodiment 1, wherein a connector needle communicates with an injection tube connected to a fluid pump. 19. An injection lead assembly of Embodiment 1, wherein the connector conductive trace is in conductivity with the pulse generator cable connected to the pulse generator.

[0122] 20. An injection lead assembly of Embodiment 1, further comprising an adhesive patch attached to the housing. 21. An injection lead assembly of Embodiment 20, wherein the adhesive patch comprises a fixing component for securing the adhesive patch to the user's skin.

[0123] 22. An injection lead assembly of Embodiment 20, wherein the adhesive patch has an open space having an adhesive surface. 23. An injection lead assembly of Embodiment 22, wherein an open space is molded to receive and secure a portion of the injection lead body.

[0124] 24. An injection lead assembly of embodiment 23, wherein the open space is molded to allow for a change in the length of the injection lead body extending from the housing. 25. An injection lead assembly of Embodiment 1, wherein the housing further comprises an injection gasket.

[0125] 26. An injection lead assembly of Embodiment 25, wherein the injection gasket is molded to receive an insertion needle and provides a fluid seal around the insertion needle. 27. An injection lead assembly of Embodiment 1, configured such that the housing is positioned subcutaneously.

[0126] 28. An injection lead assembly of embodiment 27 further comprising a subcutaneous injection port. 29. An injection lead assembly of embodiment 28, further comprising a sealing gasket sealed to the subcutaneous injection port.

[0127] 30. An injection lead assembly of Embodiment 1, wherein one or more of the injection lumen, outlet port, internal wire, or tip electrode are formed of a bioabsorbable or biodegradable material. 31. An injection lead assembly of Embodiment 1, further comprising a receiver configured to wirelessly receive electrical signals.

[0128] 32. An injection lead assembly comprising: a receiver having a receiving antenna that wirelessly receives power from a transmitting component; a subcutaneous housing having a needle receptacle, a housing lumen, a pin receptacle, and a housing conductive trace; and an injection lead body having an injection lumen, an outlet port, an internal wire, and a tip electrode, wherein the injection lead assembly forms an electrical path for transmitting an electrical signal across the receiving antenna, the housing conductive trace, the internal wire, and the tip electrode; and the injection lead assembly forms a fluid path for transmitting fluid across the injection lumen and the outlet port.

[0129] 33. An injection lead assembly of embodiment 32, in which power is transmitted by a transmission module. 34. An injection lead assembly of embodiment 32, wherein the subcutaneous housing further comprises a subcutaneous injection port.

[0130] 35. An injection lead assembly of embodiment 34, wherein the subcutaneous injection port is in communication with the injection lumen. 36. An injection lead assembly of embodiment 32, having a coil in the receiving antenna.

[0131] 37. An injection lead assembly of embodiment 32, further comprising a fastener, the fastener being composed of at least one of a bioabsorbable material or a biodegradable material. 38. A method for multimodal stimulation, comprising: receiving an electrical signal at a connector; sending the electrical signal to the tip electrode of an internal injection lead body via a connector conductive trace, a connector metal pin, a housing pin receptacle, a housing conductive trace, and an internal wire of the injection lead body at a first time point; receiving a fluid at the connector; and sending the fluid to the outlet port of the injection lead body via an internal lumen of the connector, a connector needle, a housing needle receptacle, a housing lumen, and an injection lumen of the injection lead body at a second time point.

[0132] 39. The method of Embodiment 38, wherein the first time point and the second time point are approximately the same time. 40. The method of Embodiment 38, wherein at least one of an electrical signal or a fluid is received based on user input.

[0133] 41. The method of Embodiment 38, wherein at least one of an electrical signal or a fluid is received based on a pre-programmed setting. 42. The method of embodiment 38, wherein an electrical signal is received by a wireless subcutaneous receiver.

[0134] 43. The method of Embodiment 38, wherein the fluid is received at a subcutaneous injection port. 44. A method for positioning an injection lead body, comprising attaching an injection lead assembly to a needle having a needle tip at a first end and a needle hub at a second end opposite to the first end, wherein the injection lead assembly has an injection lead body having a proximal end and a tip, and the attachment includes inserting the needle tip through the tip via the proximal end, the tip having a tip electrode and an exit port, inserting the injection lead assembly attached to the needle through the user's skin such that the needle tip is located near a nerve and the needle hub is located outside the user's skin, applying force to the needle hub to position the needle hub toward the user's skin, applying force to the needle hub to advance the injection lead assembly attached to the needle so that it advances substantially parallel to the nerve, and removing the needle from the injection lead assembly such that the tip having the tip electrode and exit port is substantially parallel to the nerve.

[0135] 45. The method of Embodiment 44, wherein the injection lead assembly has greater flexibility than the needle. 46. ​​The method of Embodiment 44, further comprising positioning the proximal end in the open space of the adhesive patch of the injection lead assembly.

[0136] 47. The method of Embodiment 44, further comprising transmitting an electrical signal to the tip electrode via the injection lead assembly at a first time point. 48. The method of Embodiment 47, further comprising, at a second point in time, flowing fluid to the outlet port through the injection lead assembly.

[0137] 49. The method of Embodiment 48, wherein the first time point and the second time point are the same time point. 50. The method of Embodiment 44, further comprising transmitting an electrical signal to a tip electrode and receiving a response indicating the position of an injection lead assembly based on the transmission of an electrical signal to the tip electrode.

[0138] 51. The method of Embodiment 44, further comprising supplying a detection medium through an outlet port and determining the location of an injection lead assembly based on the detection of the location of the detection medium.

[0139] All aspects described herein (including references incorporated by reference, appended claims, abstracts, and drawings) can be combined in any order, in part or in whole, or in any combination or modification, unless they are incompatible or contradictory. Furthermore, unless expressly stated otherwise, or unless such substitution is inconsistent with the teachings herein, each aspect can be replaced by an alternative function that serves the same, equivalent or similar purpose. Thus, unless expressly stated otherwise, each aspect disclosed herein is merely an example of an equivalent or similar feature. The present invention is intended to be defined by the appended claims and their legal equivalents.

Claims

1. An injection lead assembly, A housing having a needle receptacle, a housing lumen, a pin receptacle, and a housing conductive trace, A combined drug pump and pulse generator, A connector having a connector needle, an internal lumen communicating with the connector needle and connected to the drug pump, a metal pin, and a connector conductive trace that is electrically connected to the metal pin and connected to the pulse generator, An injection lead body having an injection lumen communicating with the housing lumen, an outlet port opening into the injection lumen, an internal wire conducting to the housing conductive trace, and a proximal electrode and a tip electrode conducting to the pulse generator via the internal wire, Equipped with, The injection lead assembly forms an electrical path for transmitting electrical signals in the following order: the connector conductive trace, the metal pin, the housing conductive trace, the internal wire, and the tip electrode, with the base electrode functioning as effective ground. The injection lead assembly forms a fluid path for delivering fluid in the order of the internal lumen, the connector needle, the injection lumen, and the outlet port, and the outlet port delivers the fluid supplied from the drug pump to the outside of the injection lead assembly. An injection lead assembly wherein the drug pump comprises a spring system including at least one spring, wherein the compression of the spring causes the transmission of the fluid across the internal lumen, and the contraction of the spring causes a second fluid to be collected from an external container into the drug pump.

2. The injection lead assembly according to claim 1, further comprising: a housing that further comprises a first gasket that forms a fluid seal around the connector needle inserted into the needle receptacle and closes when the connector needle is later removed; and a second gasket that forms a fluid seal around the metal pin inserted into the pin receptacle and closes when the metal pin is later removed.

3. The injection lead assembly according to claim 1, wherein the housing further comprises a first gasket that forms a fluid seal around the connector needle inserted into the needle receptacle and closes when the connector needle is later removed, and a second gasket that forms a fluid seal around the metal pin inserted into the pin receptacle and closes when the metal pin is later removed, wherein at least one of the first gasket or the second gasket includes an inline filter.

4. The injection lead assembly according to claim 1, wherein the housing further comprises a first gasket that forms a fluid seal around the connector needle inserted into the needle receptacle and closes when the connector needle is later removed, and a second gasket that forms a fluid seal around the metal pin inserted into the pin receptacle and closes when the metal pin is later removed, wherein at least one of the first gasket or the second gasket includes an inline filter, and the inline filter includes an antimicrobial material or an antimicrobial coating.

5. The injection lead assembly according to claim 1, wherein the housing further comprises a housing connecting component, the connector further comprises a connector connecting component, and the housing connecting component is molded to receive the connector connecting component.

6. The injection lead assembly according to claim 1, wherein the housing further comprises a housing connecting component, and the connector further comprises a connector connecting component, wherein the connector connecting component is molded to receive the housing connecting component.

7. The injection lead assembly according to claim 1, wherein the pin receptacle comprises an electrical surface for electrical contact with the pulse generator, the housing conductive trace, the internal wire, and the tip electrode.

8. The injection lead assembly according to claim 1, wherein the connector conductive trace is electrically connected to the pulse generator cable connected to the pulse generator.

9. Further comprising a safety mechanism including at least one of a volume sensor, a signal sensor, a clock, or a counter, The injection lead assembly according to claim 1, wherein the safety mechanism is configured such that the volume sensor, signal sensor, clock, or counter observes at least one of the characteristics of an electrical stimulus based on an electrical signal output from the pulse generator or the fluid characteristics of the fluid supplied from the drug pump, and generates a signal in response to at least one of the characteristics of the electrical stimulus or the fluid characteristics.

10. The injection lead assembly according to claim 1, further comprising a visual positioning detector, wherein the visual positioning detector transmits a detection medium to the exit port.

11. The injection lead assembly according to claim 1, further comprising a placement detector, the placement detector transmitting a low-voltage electrical signal to the tip electrode.

12. The injection lead assembly according to claim 1, wherein the injection lead body is configured to be placed inside a nerve sheath.

13. The injection lead assembly according to claim 1, further comprising a needle guide system molded to control the insertion angle of the injection lead body.

14. An injection lead assembly according to claim 13, wherein the needle guide system is adjustable to different insertion angles and can be fixed at a selected insertion angle.

Images