Methods for multimodal pain management, injection lead assemblies, and non-temporary computer-readable media

Abstract

The present invention provides devices, systems, and methods for pain management (e.g., motor pain management, sensory pain management, etc.), vasodilation, and / or arteriovenous fistula maturation. [Solution] The injection lead assembly 100 comprises a housing 140 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 110 having an injection lumen, an outlet port, an internal wire, and a tip electrode 112. 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. 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 118.

Claims

1. A method for multimodal pain management, The injection lead assembly is connected to a first supply source by connecting the first connector to the housing of the injection lead assembly, and the first supply source delivers a first stimulus to a subcutaneous target site via the injection lead body of the injection lead assembly. The first connector can be removed from the housing without shifting the injection lead body, The method includes connecting the injection lead assembly to a second source by connecting a second connector to the housing, and the second source delivering a second stimulus, different from the first stimulus, to the subcutaneous target site via the injection lead body, The injection lead body has an injection lumen, an outlet port, an internal wire, and a tip electrode. A method wherein one of the first and second stimuli is a chemical stimulus by a fluid delivered through the outlet port, and the other of the first and second stimuli is an electrical stimulus by the tip electrode.

2. In the method according to Claim 1, The first stimulus is a chemical stimulus, and the first supply source is a drug pump. A method wherein the second stimulus is an electrical stimulus and the second source is a pulse generator.

3. In the method according to Claim 1, The first stimulus is an electrical stimulus, and the first source is a pulse generator. A method wherein the second stimulus is a chemical stimulus and the second source is a drug pump.

4. In the method according to Claim 1, The method further includes connecting the cap to the housing after removing the first connector and before connecting the second connector, The cap is treated with an antibacterial agent in this method.

5. In the method according to Claim 1, A method for delivering the chemical stimulus, comprising delivering a fluid from a drug pump to the subcutaneous target site through the internal lumen of the first or second connector, the connector needle, the housing lumen, the injection lumen, and the outlet port.

6. In the method according to Claim 1, A method for delivering the electrical stimulus, comprising sending an electrical signal from a pulse generator across the connector conductive traces, metal pins, housing conductive traces, internal wires, and end-side electrodes of the first or second connector.

7. In the method according to Claim 1, A method further comprising positioning the injection lead body parallel to a nerve or vein at the subcutaneous target site before delivering the first stimulus.

8. In the method according to Claim 1, A method for removing the first connector from the housing, comprising disengaging the snap-fit ​​connection between the first connector and the housing.

9. An infusion lead assembly for multimodal pain management, The injection lead assembly is A housing comprising a needle receptacle, a housing lumen, a pin receptacle, and a housing conductive trace, A first connector detachably connected to the housing, the first connector connecting the housing to a first source that provides a first stimulus, A second connector, detachably connected to the housing, connects the housing to a second source that provides a second stimulus different from the first stimulus, An injection lead body comprising: an injection lumen communicating with the housing lumen; an outlet port opening into the injection lumen and delivering fluid to a subcutaneous target site outside the injection lead assembly; an internal wire in conductivity with the housing conductive trace; and a tip electrode; Equipped with, The first connector is removable from the housing without displacing the injection lead body, and when the first connector is removed, the second connector is removablely connected to the housing. An injection lead assembly in which one of the first and second stimuli is a chemical stimulus by a fluid delivered through the outlet port, and the other of the first and second stimuli is an electrical stimulus by the tip electrode.

10. In the injection lead assembly according to claim 9, An injection lead assembly comprising: a housing further comprising: a first gasket that forms a fluid seal around a connector needle inserted into the needle receptacle and closes when the connector needle is removed; and a second gasket that forms a fluid seal around a metal pin inserted into the pin receptacle and closes when the metal pin is removed.

11. In the injection lead assembly according to claim 10, An injection lead assembly wherein at least one of the first gasket or the second gasket is equipped with an in-line filter made of an antimicrobial material or coated with an antimicrobial material.

12. In the injection lead assembly according to claim 9, An injection lead assembly wherein the housing further comprises housing connecting components, the first connector and the second connector each comprise connector connecting components, and the housing connecting components are molded to receive each of the connector connecting components and form a snap-fit ​​connection.

13. In the injection lead assembly according to claim 9, The device further includes a cap that can be connected to the housing when neither the first connector nor the second connector is connected to the housing, The cap includes a lumen insert molded to fit into the housing lumen and a trace insert molded to fit into the housing conductive trace. An injection lead assembly in which the lumen insert and the trace insert are treated with an antimicrobial agent.

14. In the injection lead assembly according to claim 9, The injection lead body further comprises a proximal end electrode, The proximal electrode of the injection lead assembly functions as an effective ground when the electrical stimulus is delivered via the proximal electrode.

15. In the injection lead assembly according to claim 9, An injection lead assembly wherein the injection lead body can be positioned parallel to a nerve or vein at the subcutaneous target site, and the exit port and the tip electrode are spaced apart along the longitudinal direction of the nerve or vein.

16. In the injection lead assembly according to claim 9, An injection lead assembly further comprising a safety mechanism that tracks at least one of an electrical signal-based stimulus characteristic or fluid characteristic and generates a control signal when at least one of the stimulus characteristic or fluid characteristic reaches a threshold.

17. A non-temporary computer-readable medium storing instructions, When the instruction is executed by one or more processors, the one or more processors will be instructed to: The injection lead assembly receives a first input indicating a first stimulus to be delivered to a subcutaneous target site via the injection lead assembly, the injection lead assembly comprising a housing, a connector removably connected to the housing, and an injection lead body having an injection lumen, an outlet port, an internal wire, and a tip electrode. A first control signal is generated through the injection lead assembly to deliver the first stimulus, the first stimulus being either a chemical stimulus by a fluid delivered through the outlet port, or an electrical stimulus by the tip electrode. The injection lead assembly delivers a second input, which indicates a second stimulus different from the first stimulus, to the subcutaneous target site, A non-transient computer-readable medium that generates a second control signal for delivering the second stimulus through the injection lead assembly, the second stimulus being either a chemical stimulus by a fluid delivered through the outlet port, or an electrical stimulus by the tip-side electrode.

18. In the non-temporary computer-readable medium according to claim 17, The instruction is a non-transient computer-readable medium that causes one or more processors to track at least one of the stimulation characteristics based on the electrical stimulation or the fluid characteristics based on the chemical stimulation, and to prevent the first stimulation or the second stimulation from being delivered beyond a threshold characteristic.

19. In the non-temporary computer-readable medium according to claim 17, The instruction is a non-temporary computer-readable medium that causes one or more processors to apply a trained machine learning model to determine at least one of the amount, frequency, or duration of the first stimulus or the second stimulus based on the current input associated with the user.

20. In the non-temporary computer-readable medium according to claim 17, The instruction is a non-temporary computer-readable medium that causes one or more processors to generate the first control signal or the second control signal based on at least one of a pre-programmed setting, user input, or event-based trigger.

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