Systems, devices, apparatus, and methods for retaining elongated structures in tissue

Abstract

Some embodiments of the present disclosure provide an anchoring device for reversibly retaining at least one of a catheter and a needle (e.g., or other associated device) within tissue. The device includes a cylinder including a wall, an outer surface, and one or more claws. In some embodiments, each claw includes a portion thereof that is at least one of flexibly integral with and flexibly secured to at least one of the outer surface and the wall, and can be configured to protrude away from the surface of the cylinder when in a deployed state. In a non-deployed state, each claw can be configured to coil or otherwise fold in response to rotation of the cylinder in a first direction so as to be at least one of directly adjacent the outer surface and received by a recess or opening in at least one of the surface and wall of the cylinder.

Description

[Background technology]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 442,100, filed January 30, 2023, and entitled "SYSTEM, DEVICE AND METHOD FOR RETAINING TUBE WITHIN TISSUE." Some embodiments of the presently disclosed invention are also related to PCT Publication No. WO2022221452A1. Both of the foregoing disclosures are incorporated herein by reference in their entireties.

[0002] Elongated structures, including tubes, catheters, leads, and / or other solid and lumen-based structures (hereinafter both throughout this disclosure referred to individually as "catheters," and thereafter for the plural as "catheters," whether such structures contain lumens or not, i.e., are solid structures) and various other instruments are often used in numerous medical procedures to deliver and / or remove fluids, air, electrical pulses / currents, radiofrequency, implants, and the like to tissue. Such structures traverse tissue, more specifically, skin. Precise placement of the structure is often required, both relative to the skin or tissue at initial placement as well as the ends of the structure, to keep the structure precisely placed during use. In some cases, for example, linear movement of the structure (e.g., along its longitudinal axis) is detrimental to the associated medical procedure being performed.

[0003] Thus, a need exists to hold, or at least substantially hold, moving structures in place within tissue so that an associated medical procedure can be performed. Summary of the Invention [Means for solving the problem]

[0004] Inventive embodiments of the present disclosure are directed at least to an anchoring device for reversibly retaining a device within tissue, and more particularly, for reversibly retaining at least one of a tube, a catheter, and a needle within tissue.

[0005] In some embodiments, an anchoring device for reversibly retaining a catheter or tube within tissue is provided. The device includes a cylinder including a wall, an outer surface, and one or more prongs. Each prong has a portion thereof that is at least one of flexibly integral with and flexibly secured to at least one of the outer surface and the wall, and is configured to protrude away from the surface of the cylinder when in a deployed state. In a non-deployed state, the prong is configured to coil or otherwise fold in response to rotation of the cylinder in a first direction so as to be at least one of directly adjacent the outer surface and / or received by a recess or opening in at least one of the surface and wall of the cylinder.

[0006] Variations of at least some of the embodiments described above may further include the following elements, features, functionality, structures, materials, steps, and / or explicit descriptions that result in still further embodiments of the present disclosure: - one or more of the prongs comprises a plurality of prongs; - a plurality of claws arranged around the circumference of the cylinder; the plurality of claws being evenly spaced around the circumference of the cylinder; - each prong is configured to be disposed within tissue; each claw includes a surface area configured to assist in retaining at least one of the catheter and needle within the tissue, and optionally includes structural rigidity to hold the claw in place within the tissue so that it does not collapse or collapse under use; each prong including at least one of a height relative to a surface of the cylinder and a lip configured to interact with tissue to maintain at least the distal end of the catheter within the tissue in response to an axial force being placed on the catheter or component in a proximal direction thereof; each prong including a barb configured to interact with tissue to retain the catheter within the tissue and to prevent longitudinal movement of the catheter in at least a first direction; each claw is configured as a propeller-like structure in the deployed state, The propeller-like structure is configured with a pitch of 1 to 90 degrees relative to the axis of the cylinder; - the one or more claws or the plurality of claws comprises at least two claws; - the one or more claws or the plurality of claws comprises at least three claws; - the one or more claws or the plurality of claws comprises at least four claws; - the claw or claws are arranged in one or more planes that lie at an angle to the longitudinal axis of the cylinder, optionally the angle being perpendicular to the longitudinal axis; - one or more claws or claws are arranged in one or more planes aligned with the longitudinal axis of the cylinder; - the claw or claws are arranged in at least two planes arranged at an angle to the longitudinal axis of the cylinder; the catheter includes one or more electrodes; the catheter including or associated with a pulse generator; - the claw or claws are arranged in at least two planes that lie at an angle to the longitudinal axis of the cylinder, optionally the angle being perpendicular to the longitudinal axis; - the claw or claws are arranged in at least two planes that lie at an angle to the longitudinal axis of the cylinder; - optionally, the angle is perpendicular to the longitudinal axis; - barbs associated with one or more prongs arranged in a first plane of the at least two planes are shaped and arranged to impede longitudinal movement of the catheter in a first direction; and the barbs associated with one or more prongs arranged in a second of the at least two planes are shaped and arranged to impede longitudinal movement of the catheter in a second direction opposite the first direction. may include one and / or another of, in some variations, a plurality of, in some variations (when not mutually exclusive), a majority of, and / or substantially all (and even more so, in some variations, all) of.

[0007] In some embodiments, a system for reversibly retaining a catheter within tissue is provided, including a device of any of the embodiments disclosed in the present disclosure, including those presented above, and at least one of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire.

[0008] In some embodiments, a system for reversibly retaining a catheter within tissue is provided, including a device of any of the embodiments disclosed in the present disclosure, including those presented above, and including only one of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire.

[0009] In some embodiments, a system for reversibly retaining a catheter within tissue is provided, including a device of any of the embodiments disclosed in the present disclosure, including those presented above, and at least two of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire.

[0010] In some embodiments, a system for reversibly retaining a catheter within tissue is provided, including any of the device embodiments disclosed in the present disclosure, including those presented above, and including only two of the catheter, needle, electrode, liner extrusion, jacket extrusion, and conductor wire.

[0011] In some embodiments, a system for reversibly retaining a catheter within tissue is provided, including any of the device embodiments disclosed in the present disclosure, including those presented above, and including at least three of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire.

[0012] In some embodiments, a system for reversibly retaining a catheter within tissue is provided, including any of the device embodiments disclosed in the present disclosure, including those presented above, and including only three of the catheter, needle, electrode, liner extrusion, jacket extrusion, and conductor wire.

[0013] In some embodiments, a system for reversibly retaining a catheter within tissue is provided, including any of the device embodiments disclosed in the present disclosure, including those presented above, and at least four of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire.

[0014] In some embodiments, a system for reversibly retaining a catheter within tissue is provided, including any of the device embodiments disclosed in the present disclosure, including those presented above, and including only four of the catheter, needle, electrode, liner extrusion, jacket extrusion, and conductor wire.

[0015] In some embodiments, a system for reversibly retaining a catheter within tissue is provided, including any of the device embodiments disclosed in the present disclosure, including those presented above, and at least five of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire.

[0016] In some embodiments, a system for reversibly retaining a catheter within tissue is provided, including any of the device embodiments disclosed in the present disclosure, including those presented above, and including only five of the catheter, needle, electrode, liner extrusion, jacket extrusion, and conductor wire.

[0017] In some embodiments, a system for reversibly retaining a catheter within tissue is provided, including a device of any of the embodiments disclosed in the present disclosure, including those presented above, including a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire.

[0018] In some embodiments, a method for retaining at least a catheter within tissue is provided, comprising providing an anchoring device or system according to any of such embodiments disclosed herein, including those set forth above, wherein the catheter and cylinder form an assembly, inserting the assembly through a surface of an insertion site toward a target area, and rotating the cylinder in a first direction such that one or more prongs of the anchoring device deploy within the tissue. The method further comprises rotating the cylinder in a second direction opposite the first direction such that the one or more prongs of the anchoring device are wrapped and / or otherwise folded so that they reside directly adjacent an outer surface of the cylinder, and optionally are received by a recess or opening in at least one of the surface and wall of the cylinder.

[0019] In some embodiments, a method for retaining at least a catheter within tissue is provided, comprising providing an anchoring device or system according to any of such embodiments disclosed herein, including those set forth above, wherein the catheter and cylinder form an assembly, and the catheter includes one or more electrodes for applying an electrical current to the tissue. The method comprises the following (which leads to still further embodiments of the present disclosure): - sterilizing the surface of the tissue at the insertion site; - anesthetizing the surface at the insertion site with a local anesthetic; - inserting the assembly through a surface of an insertion site toward a target nerve, optionally under ultrasound imaging guidance, wherein at least one of an ultrasound image produced by the ultrasound imaging guidance and eliciting appropriate muscle contractions of muscles adjacent to the target nerve via one or more electrodes is configured to confirm that a portion of the catheter is adjacent to the target nerve; - rotating the cylinder in a first direction such that one or more prongs of the anchoring device are deployed within the tissue; rotating the cylinder in a second direction opposite to the first direction so that one or more claws of the tethering device are wrapped and / or otherwise folded so as to lie directly adjacent the outer surface of the cylinder and, optionally, received by a recess or opening in at least one of the surface and wall of the cylinder; may include any one or more, preferably a plurality thereof, in some embodiments a majority thereof, in some embodiments substantially all thereof, and in some embodiments all thereof.

[0020] In some embodiments, a method for use of a catheter pain management device or system is provided, comprising providing an anchoring device or system according to any of such embodiments disclosed herein, including those set forth above, wherein the catheter and cylinder (and in some embodiments, optionally, the needle) form an assembly, the catheter including a portion containing a medical device for positioning the medical device adjacent to and / or delivering the medical device to a particular area of ​​tissue, and optionally, removably securing the needle (if present) to the catheter, and delivering a predetermined amperage, frequency, and / or duration. the needle to a pulse generator configured to deliver a pulse of electrical current to the target nerve, connecting tubing configured to communicate with the needle lumen to a syringe filled with a glucose solution, flushing the tubing and needle lumen to remove any air from the lumen, sterilizing the surface of the tissue at the insertion site, anesthetizing the surface at the insertion site with a local anesthetic, injecting the glucose solution through the needle to create an area of ​​fluid by hydrodissection adjacent to the target nerve, and optionally inserting the assembly through the surface of the insertion site toward the target nerve under ultrasound imaging guidance. At least one of an ultrasound image produced by ultrasound imaging guidance and eliciting appropriate muscle contractions in muscles adjacent to the target nerve via one or more electrodes is configured to confirm that the tip of the needle is adjacent to the target nerve.In some embodiments, the method includes the steps of: unlocking the needle from the catheter; sliding the catheter a predetermined distance into the hydrodissected area adjacent to the target nerve; removing the needle from the tissue; activating the pulse generator; and optionally data-linking the pulse generator to a smart device configured to control the pulse generator via at least one of a dedicated application running on the smart device and a user interface thereof; establishing at least one of a lower stimulation threshold current and an upper stimulation threshold current for the pulse generator using at least one of the dedicated application and the user interface; rotating the cylinder in a first direction such that one or more claws of the anchoring device are deployed within the tissue to retain at least the catheter within the tissue; and attaching the needle to the insertion site using surgical adhesive glue. the catheter; applying a waterproof covering configured to cover the catheter outside the surface of the tissue so as to keep the injection port / hub of the catheter outside the waterproof covering; closing the injection port / hub with a clave; injecting a local anesthetic solution through a syringe to produce a primary nerve block; crowning the clave with a luer lock component; and, to remove the catheter, wrapping or otherwise folding the one or more prongs of the anchoring device so that they are directly adjacent to the outer surface of the cylinder and, optionally, rotating the cylinder in a second direction opposite the first direction so that they are received by a recess or opening in at least one of the surface and wall of the cylinder.

[0021] These and other features, functions / functionality, steps, structures, and / or specific explanations may be found in the following detailed description and corresponding figures, and the brief description that follows. [Brief explanation of the drawings]

[0022] [Figure 1A] FIG. 1A is a side view of an anchoring device, according to some embodiments of the present disclosure.

[0023] [Figure 1B] FIG. 1B is an end view of the anchoring device of FIG. 1A, according to some embodiments of the present disclosure.

[0024] [Figure 1C] FIG. 1C is a cross-sectional view of the anchoring device of FIG. 1A, according to some embodiments of the present disclosure.

[0025] [Figure 1D] FIG. 1D is a perspective view of the anchoring device of FIG. 1A, according to some embodiments of the present disclosure.

[0026] [Figure 2] FIG. 2 is a side view of an anchoring device, according to some embodiments, used in association with a medical system / catheter for delivering electrical pulses to tissue, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0027] (Detailed explanation) 1A-D , an anchoring device 100 for reversibly retaining at least one of a catheter and (for example) a needle within tissue is provided. The device 100 includes a cylinder or cylinder-like structure 106 including a wall 108, an outer surface 110, and one or more claws 112. Each claw 112 can include at least a portion thereof that is flexibly integral with and / or flexibly secured to at least one of the outer surface 110 and the wall 108, and can be configured to protrude away from the surface 110 of the cylinder 106 when in the deployed state. In the undeployed state, each claw 112 can be configured to coil or otherwise fold in response to rotation of the cylinder 106 in a first direction 114 such that at least one of each claw resides directly adjacent to the outer surface 110. In some embodiments, one or more of the claws 112 (preferably all of the claws) are received by recesses or openings 116 in at least one of the surface 110 of the cylinder 106 and the wall 108 of the cylinder 106 upon folding / wrapping.

[0028] As shown in the figures, in some embodiments, multiple claws 112 may be provided and arranged around the circumference of the cylinder 106 and may be evenly spaced around the circumference of the cylinder 106.

[0029] 2 illustrates an example of a catheter 154, 162 of a pain management device 150 configured to deliver at least one of electrical pulses and fluid (e.g., medication) to which an anchoring device 100 can be used / secured. The catheters 154, 162 (similar pain management device embodiments are also disclosed in WO2022221452A1, incorporated herein by reference) can include a proximal connector 152 (which can be connected to a fluid source), a second connector 156 and associated tubing 158 (which can accommodate an electrical connector and a wire / lead, respectively, for connecting an external electrical stimulation device to the device 150), and a third connector 158, which can be a Luer lock. A pulse generator 160 is connected to the catheters / tubing 154 and / or 158 via the Luer lock and to the distal tubing / catheter 162 to deliver fluid and / or electrical stimulation (e.g., via electrodes 164) to tissue into which the device 150 is inserted. In some embodiments, the anchoring device 100 is anchored to the portion of the distal catheter 162 that is inserted into tissue to keep at least the distal catheter 162 in place. The anchoring device 100 of the present disclosure can be anchored at a point along the distal catheter, according to some embodiments. Specifically, the anchoring device can be anchored to the portion of the catheter that is disposed within the tissue at any point therein.

[0030] The surface area of ​​each claw is approximately 0.1 to 100 mm 2, which has been found to assist in retaining at least one of the catheters (and, in some embodiments, the needle) within the tissue. Similarly, each prong may include a height of 0.5 mm to 10 mm relative to the surface 110 of the cylinder 106 and at least one edge configured to interact with tissue to hold at least the distal end of the catheter 102 and / or needle 104 within the tissue in response to an axial force being placed on the catheter 102 and / or needle 104 proximally. Each prong, in some embodiments, may include at least one of a triangular shape (as shown), a curved shape, a "W" shape, an "M" shape, and a hook shape (e.g., a "fishhook") configured to perform the task of securing the catheter in place. Such shapes include one or more sharp or barbed portions that may be temporarily at least slightly embedded in the tissue and hold the catheter in place for the period of time required to perform the medical procedure or aid.

[0031] In some embodiments, as initially described above, one or more of the claws are configured as or include at least one barb 118 portion configured to interact with tissue to retain the catheter and / or needle within the tissue. Moreover, in some embodiments, each claw 112 can be configured as or include a smooth portion or curve-like structure configured to interact with tissue to retain the catheter 102 and / or needle 104 within the tissue. The geometry of a claw with smooth edges can unexpectedly provide a sufficient retention force to keep the catheter in place within the tissue. The claws can include different geometric shapes, including semicircular, semi-elliptical, triangular, square, rectangular, and / or polygonal shapes with different numbers of sides.

[0032] In some embodiments, one or more of the claws 112 can be configured as a propeller-like structure in the deployed state (as shown), and the propeller-like structure can be configured with a pitch of 1 degree to 90 degrees (and any range therebetween) relative to the axis of the cylinder 106.

[0033] The one or more claws may have a number of 1 to 1,000 (or more), preferably less than 100, more preferably less than 50, and most preferably 1 to 20, 1 to 19, 1 to 18, 1 to 17, 1 to 16, 1 to 15, 1 to 14, 1 to 13, 1 to 12, 1 to 11, 1 to 10, 1 to 9, 1 to 8, 1 to 7, 1 to 6, 1 to 5, 1 to 4, 1 to 3, 1 to 2, 2 to 20, 2 to 19, 2 to 18, 2 to 17, 2 to 16, 2 to 15, 2 to 14, 2 to 13, 2 to 12, 2 to 11, 2 to 10, 2 to 9, 2 to 8, 2 to 7, 2 to 6, 2 to 5, 2 to 4, 2 to 3, 3 to 20, 3 to 19, 3 to 18 , 3-17, 3-16, 3-15, 3-14, 3-13, 3-12, 3-11, 3-10, 3-9, 3-8, 3-7, 3-6, 3-5, 3-4, 4-20, 4-19, 4-18, 4-17, 4-16, 4-15, 4-14, 4-13, 4-12, 4-11, 4-10, 4-9, 4 ~8, 4~7, 4~6, 4~5, 5~20, 5~19, 5~18, 5~17, 5~16, 5~15, 5~14, 5~13, 5~12, 5~11, 5~10, 5~9, 5~8, 5~7, 5~6, 6~20, 6~19, 6~18, 6~17, 6~16, 6~15, 6~14, 6~13 , 6-12, 6-11, 6-10, 6-9, 6-8, 6-7, 7-20, 7-19, 7-18, 7-17, 7-16, 7-15, 7-14, 7-13, 7-12, 7-11, 7-10, 7-9, 7-8, 8-20, 8-19, 8-18, 8-17, 8-16, 8-15, 8-1 4, 8-13, 8-12, 8-11, 8-10, 8-9, 9-20, 9-19, 9-18, 9-17, 9-16, 9-15, 9-14, 9-13, 9-12, 9-11, 9-10, 10-20, 10-19, 10-18, 10-17, 10-16, 10-15, 10-14, 10 ~13, 10~12, 10~11, 11~20, 11~19, 11~18, 11~17, 11~16, 11~15, 11~14, 11~13, 11~12, 12~20, 12~19, 12~18, 12~17, 12~16, 12~15, 12~14, 12~13, 13~20, 1 3-19, 13-18, 13-17, 13-16, 13-15, 13-14, 14-20, 14-19, 14-18, 14-17, 14-16, 14-15, 15-20, 15-19, 15-18, 15-17, 15-16, 16-20, 16-19, 16-18, 16-17,These may include 17-20, 17-19, 17-18, 18-20, 18-19, and 19-20.

[0034] The plurality of claws 112 may be arranged in one or more planes 113 that lie perpendicular to the axis 120 of the cylinder 106. The one or more planes may preferably be fewer than 10 planes, most preferably 1-10, 1-9, 1-8, 1-7, 1-6, 1-5, 1-4, 1-3, 1-2, 2-10, 2-9, 2-8, 2-7, 2-6, 2-5, 2-4, 2-3, 3-10, 3-9, 3-8, 3-7, 3-6, 3-5, 3-4, 4-10, 4-9, 4-8, 4-7, 4-6, 4-5, 5-10, 5-9, 5-8, 5-7, 5-6, 6-10, 6-9, 6-8, 6-7, 7-10, 7-9, 7-8, 8-10, 8-9, and 9-10. Such planes can be exactly 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10, according to some embodiments. In some embodiments, the planes of the distributed claws (e.g., located around the circumference of the cylinder) can be at an acute or oblique angle to the axis 120 of the cylinder. The angle as well as the number of planes on which the claws are arranged can be calculated to provide different amounts of retention force.

[0035] In some embodiments, the barbs 118 of one set of claws arranged in one plane reside in opposite directions, and then the barbs 118 of another set of claws (e.g., an adjacent set of claws) may be arranged in a second plane such that when projecting outward, the two planes of the claws limit movement of the distal catheter 162 in both distal and proximal directions. In such embodiments, rotation of the catheter device in a first direction allows the barbs to project outward, and rotation of the catheter device in a second direction opposite the first (e.g., counterclockwise as opposed to clockwise) allows the claws to fold or advance (e.g., downward) so that they no longer engage or do not sufficiently engage tissue, allowing removal of the catheter device.

[0036] In some embodiments, device 150 can include one or more electrodes 164 , and device 150 can also include (in some embodiments) an electrical pulse generator 160 .

[0037] In some embodiments, a system for reversibly retaining at least one of the catheter 150 and the needle within tissue is provided and can include the device 100 (according to any of the embodiments and variations thereof described above) and, in some embodiments, at least one of the needle, the electrode 164, the liner extrusion, the jacket extrusion, and the conductor wire 158; in some embodiments, at least two of them, in some embodiments, at least three of them, in some embodiments, at least four of them, in some embodiments, at least five of them, and in some embodiments, all of them. The liner extrusion can be a 55D Pebax® liner covering the jacket extrusion, which can be, for example, a 55D Pebax® jacket. A cylinder (with prongs) can be mounted on an additional liner, which can be a 55D Pebax® liner. The catheter 150 can include a first distal electrode and a second, more distal one of the electrodes 164. The conductor wire 158 can be used, for example, to power the electrode.

[0038] In some embodiments, device 100 is spaced from the distal tip / end of the catheter (together with the assembly) a predetermined distance that can range from 10 mm to 100 mm in some embodiments. In some embodiments, the distance is preferably 20 to 40 mm, in some embodiments, 25 to 35 mm, and in still further embodiments, about 30 mm. In some embodiments, electrodes contained within the distal portion of the catheter are positioned distal to the positioning device.

[0039] In some embodiments, a method is provided for retaining at least one of the catheter 154, 162 and needle within tissue. In some such embodiments, the method comprises any of the embodiments described above, i.e., the catheters 154, 162, the cylinder 106, and, optionally, the needle (in some embodiments, the needle is first inserted into the proximal end of the catheter 154 and directed proximally through the catheter 162; thus, in some embodiments, at least the tip of the needle can protrude outward from the end of the catheter 162) form an assembly; the needle can be removably secured to at least one of the catheters 154, 162 and the cylinder 106; the needle may include a tip that can be electrically charged (e.g., in some embodiments, may be part of the electrode 164); and The catheters 154, 162 may include one or more electrodes 164 for applying electrical current to tissue. providing a mooring device or system according to

[0040] In some embodiments, the needle is coated with Parylene C, although in some embodiments, a small portion on the proximal and distal ends is not coated with Parylene C. The coating serves to insulate the needle so that when an electric current is applied to the proximal / tip end of the needle, the tip becomes electrically charged. In particular, insulation (not shown) can be included that is configured to electrically isolate the needle from the electrodes 164 of the device 150 (if included) when inserted into the catheters 154, 162. The needle (or assembly with the catheter) can be connected to an external neurostimulator (not shown), which is connected via 156.

[0041] The method may also include one and / or more of sterilizing a surface of tissue at the insertion site, anesthetizing the surface at the insertion site with a local anesthetic, and, optionally, inserting the assembly through the surface of the insertion site toward the target nerve under ultrasound imaging guidance. At least one of an ultrasound image produced by ultrasound imaging guidance and (in some embodiments) eliciting an appropriate muscle contraction of a muscle proximate to the target nerve via the charged tip of the needle is configured to confirm that the tip of the needle is adjacent to the target nerve.

[0042] The method may further include the steps of unlocking or otherwise unlocking the needle from the device 150, removing the needle from the tissue, rotating the cylinder 106 in a first direction so that one or more claws 112 of the anchoring device 100 deploy within the tissue, and rotating the cylinder 106 in a second direction opposite the first direction so that the one or more claws 112 of the anchoring device 100 are wrapped or otherwise folded so that they are directly adjacent to the outer surface of the cylinder 106 and, optionally, received by a recess or opening 116 in at least one of the surface 110 of the cylinder and the wall 108 of the cylinder 106.

[0043] In some embodiments, a method for use in conjunction with a catheter pain management device 150 or system is provided and includes providing an anchoring device or system of any of the embodiments described above. In these embodiments, the catheter 102, the cylinder 106, and optionally a needle form an assembly, and the needle can be removably secured to at least one of the catheters 154, 162 and the cylinder 106. The needle includes a tip, and the catheters 154, 162 can include one or more electrodes 164 for applying an electrical current to tissue. The method can further include removably securing the needle to the catheter and connecting the needle to an external neurostimulator 160 configured to deliver pulses of electrical current at a predetermined amperage, frequency, and / or duration.

[0044] In some embodiments, the method may further include connecting tubing configured to communicate with the needle lumen of device 150 to a syringe filled with a glucose solution, flushing the tubing lumen and the needle lumen to remove any air from the tubing lumen and the needle lumen, sterilizing the surface of the tissue at the insertion site, anesthetizing the surface at the insertion site with a local anesthetic, injecting the glucose solution through the needle to create an area of ​​fluid by hydrodissection adjacent to the target nerve, and optionally inserting the assembly through the surface of the insertion site toward the target nerve under ultrasound imaging guidance. At least one of an ultrasound image produced by ultrasound imaging guidance and eliciting appropriate muscle contractions of muscles proximate the target nerve via one or more electrodes is configured to confirm that the tip of the needle is adjacent to the target nerve.

[0045] The method may further include the steps of unlocking the needle from the device 150, sliding the catheter 162 a predetermined distance into the hydrodissected area adjacent the target nerve, removing the needle from the tissue, activating the pulse generator 160, and optionally data-linking the pulse generator to a smart device (not shown, or e.g., a remote or otherwise other computer). The smart device may be configured to control the pulse generator 160 via at least one of a dedicated application running on the smart device and its user interface, which may establish at least one of a lower and upper stimulation threshold current for the pulse generator using at least one of the dedicated application and user interface, and the method may further include the steps of rotating the cylinder 106 in a first direction such that one or more claws 112 of the anchoring device 100 deploy within the tissue to retain at least the catheter (e.g., 162) within the tissue, sealing the surface of the insertion site with surgical adhesive glue, and covering the catheter or an injection port / hub of a portion of the device 150 with a waterproof covering (e.g., a waterproof covering). the catheter is removed, the method may include applying a waterproof covering configured to cover the outside of the tissue surface to keep it out of the catheter (not shown, but well known); closing the injection port / hub with a clave; injecting local anesthetic solution through a syringe to create a primary nerve block; securing the clave with a luer lock component; and, to remove the catheter, wrapping or otherwise folding one or more claws 112 of the anchoring device 100 so that they are directly adjacent to the outer surface 110 of the cylinder 106, and optionally rotating the cylinder 106 in a second direction opposite the first direction so that they are received by a recess or opening 116 in at least one of the surface 110 of the cylinder 106 and the wall 108 of the cylinder 106. Exemplary Embodiments [Example]

[0046] Example 1 1. An anchoring device for reversibly retaining a catheter or tube within tissue, the device comprising a cylinder including a wall, an outer surface, and one or more claws, each claw including a portion thereof that is at least one of flexibly integral with and flexibly secured to at least one of the outer surface and the wall, the anchoring device being configured to protrude away from the surface of the cylinder when in a deployed state, and to coil or otherwise fold upon rotation of the cylinder in a first direction so that in a non-deployed state it is at least one of directly adjacent to the outer surface and / or received by a recess or opening in at least one of the surface of the cylinder and the wall of the cylinder. Example 2 2. The device of example 1, wherein the one or more claws comprise a plurality of claws. Example 3 3. The apparatus of example 2, wherein the plurality of claws are arranged around the circumference of the cylinder. Example 4 3. The apparatus of example 2, wherein the plurality of claws are evenly spaced around the circumference of the cylinder. Example 5 A device described in any of Examples 1-4, wherein each claw is configured to be arranged within tissue. Example 6 A device described in any of Examples 1-4, wherein each claw includes a surface area configured to assist in retaining at least one of the catheter and needle within the tissue. Example 7 A device described in any of Examples 1-6, wherein each claw portion includes at least one of a height relative to the surface of the cylinder and an edge configured to interact with tissue to maintain at least the distal end of the catheter and / or needle within the tissue in response to an axial force being placed on the catheter and / or needle in a proximal direction thereof. Example 8 A device described in any of Examples 1-7, wherein each claw portion includes a barb portion configured to interact with tissue to retain the catheter and / or needle within the tissue and to prevent longitudinal movement of the catheter in at least a first direction. Example 9 8. The device of any of Examples 1-7, wherein each claw is configured as a propeller-like structure in the deployed state. Example 10 10. The apparatus of example 9, wherein the propeller-like structure is configured with a pitch of 1 to 90 degrees relative to the axis of the cylinder. Example 11 The device of any of Examples 1-10, wherein the one or more claws or multiple claws include at least two claws. Example 12 The device of any of Examples 1-10, wherein the one or more claws or multiple claws include at least three claws. Example 13 The device of any of Examples 1-10, wherein the one or more claws or multiple claws include at least four claws. Example 14 An apparatus described in any of Examples 1-10, wherein the one or more claws or claws are arranged in one or more planes that are at an angle to the longitudinal axis of the cylinder, optionally the angle being perpendicular to the longitudinal axis. Example 15 An apparatus according to any of Examples 1-10, wherein the one or more claws or claws are arranged in one or more planes aligned with the longitudinal axis of the cylinder. Example 16 An apparatus according to any of Examples 1-10, wherein the one or more claws or claws are arranged in at least two planes that are arranged at an angle relative to the longitudinal axis of the cylinder. Example 17 The device of any of Examples 1-16, wherein the catheter comprises one or more electrodes. Example 18 The device of any of Examples 1-17, wherein the catheter comprises a pulse generator. Example 19 An apparatus described in any of Examples 1-18, wherein the one or more claws or claws are arranged in at least two planes that are at an angle to the longitudinal axis of the cylinder, and optionally, the angle is perpendicular to the longitudinal axis. Example 20 A device described in any of Examples 1-18, wherein the one or more claws or multiple claws are arranged in at least two planes that are at an angle to the longitudinal axis of the cylinder, optionally the angle being perpendicular to the longitudinal axis, and wherein the barbs associated with the one or more claws or multiple claws arranged on a first plane of the at least two planes are shaped and arranged to impede longitudinal movement of the catheter in a first direction, and the barbs associated with the one or more claws or multiple claws arranged on a second plane of the at least two planes are shaped and arranged to impede longitudinal movement of the catheter in a second direction opposite the first direction. Example 21 A system for reversibly retaining a catheter within tissue, comprising a device described in any of Examples 1-20 and at least one of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire. Example 22 A system for reversibly retaining at least one of a catheter and a needle within tissue, comprising a device described in any of Examples 1-20 and at least two of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire. Example 23 A system for reversibly retaining at least one of a catheter and a needle within tissue, comprising a device described in any of Examples 1-20 and at least three of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire. Example 24 A system for reversibly retaining at least one of a catheter and a needle within tissue, comprising a device described in any of Examples 1-20 and at least four of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire. Example 25 A system for reversibly retaining at least one of a catheter and a needle within tissue, comprising a device described in any of Examples 1-20 and at least five of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire. Example 26 A system for reversibly retaining at least one of a catheter and a needle within tissue, comprising a device described in any of Examples 1-20, a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire. Example 27 A method for retaining at least one of a catheter and a needle within tissue, comprising: providing an anchoring device described in any of Examples 1-20 or an anchoring system described in any of Examples 21-26, wherein the catheter and cylinder form an assembly; inserting the assembly through a surface of an insertion site toward a target area; rotating the cylinder in a first direction so that one or more claws of the anchoring device deploy within the tissue; and rotating the cylinder in a second direction opposite to the first direction so that the one or more claws of the anchoring device wrap and / or otherwise fold so that they are directly adjacent to the outer surface of the cylinder, and optionally are received by a recess or opening in at least one of the surface and wall of the cylinder. Example 28 A method for retaining at least one of a catheter and a needle within tissue, comprising providing an anchoring device as described in any of Examples 1-20 or an anchoring system as described in any of Examples 21-26, wherein the catheter and cylinder form an assembly, and the catheter includes one or more electrodes for applying an electric current to the tissue; sterilizing a surface of the tissue at an insertion site; anesthetizing the surface at the insertion site with a local anesthetic; and optionally, inserting the assembly through the surface of the insertion site toward a target nerve under ultrasound imaging guidance, wherein an ultrasound image produced by the ultrasound imaging guidance is obtained. and eliciting an appropriate muscle contraction of a muscle proximate to the target nerve via one or more electrodes, wherein at least one of the catheter and the one or more electrodes is configured to confirm that a portion of the catheter is adjacent to the target nerve; rotating the cylinder in a first direction such that one or more claws of the anchoring device are deployed within the tissue; and rotating the cylinder in a second direction opposite the first direction such that the one or more claws of the anchoring device are wrapped and / or otherwise folded so that they reside directly adjacent to an outer surface of the cylinder, and optionally received by a recess or opening in at least one of the surface and wall of the cylinder. Example 29 10. A method for use of a catheter pain management device or system, comprising providing an anchoring device as described in any of Examples 1-20 or an anchoring system as described in any of Examples 21-26, wherein the catheter and cylinder, and optionally the needle, form an assembly, the catheter including a portion containing a medical device for positioning and / or delivering a medical device adjacent to a specific area of ​​tissue; removably securing the needle to the catheter; connecting the needle to a pulse generator configured to deliver a pulse of electrical current at a predetermined amperage, frequency, and / or duration; connecting tubing configured to communicate with the lumen of the needle to a syringe filled with a glucose solution; flushing the tubing and needle lumen to remove any air from the lumen of the tubing and needle; sterilizing the surface of the tissue at the insertion site; anesthetizing the surface at the insertion site with a local anesthetic; injecting the glucose solution through the needle to create an area of ​​fluid by hydrodissection adjacent to the target nerve; and optionally, delivering the assembly to the target nerve through the surface of the insertion site under ultrasound imaging guidance. and inserting the needle toward the target nerve, wherein at least one of an ultrasound image produced by ultrasound imaging guidance and eliciting appropriate muscle contractions of muscles adjacent to the target nerve via one or more electrodes is configured to confirm that the tip of the needle is adjacent to the target nerve; unlocking the needle from the catheter; sliding the catheter a predetermined distance into the hydrodissected area adjacent to the target nerve; removing the needle from the tissue; activating a pulse generator; and optionally data-linking the pulse generator to a smart device, the smart device configured to control the pulse generator via at least one of a dedicated application running on the smart device and a user interface thereof; establishing at least one of a lower stimulation threshold current and an upper stimulation threshold current for the pulse generator using at least one of the dedicated application and the user interface; and rotating the cylinder in a first direction such that one or more claws of the anchoring device are deployed within the tissue to retain at least the catheter within the tissue.a method comprising sealing the surface of the insertion site with a surgical adhesive glue, applying a waterproof covering configured to cover the catheter outside the surface of the tissue so as to keep the injection port / hub of the catheter outside the waterproof covering, closing the injection port / hub with a clave, injecting a local anesthetic solution through a syringe to produce a primary nerve block, securing the clave with a luer lock component, and, to remove the catheter, wrapping or otherwise folding one or more prongs of the anchoring device so that they lie directly adjacent the outer surface of the cylinder and, optionally, rotating the cylinder in a second direction opposite the first direction so that they are received by a recess or opening in at least one of the surface and wall of the cylinder.

[0047] (General considerations) While various inventive embodiments have been described and illustrated herein, those skilled in the art will readily envision various other means and / or structures for performing the functions and / or obtaining one or more of the results and / or advantages described herein, and each such variation and / or modification is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that any parameters, dimensions, materials, and configurations described herein are intended to be examples, and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application or applications in which the inventive teachings disclosed herein are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. Accordingly, it should be understood that the foregoing embodiments are presented by way of example only, and that, within the scope of the claims supported by this disclosure and their equivalents, inventive embodiments may be practiced otherwise than as specifically described and claimed. The inventive embodiments of the present disclosure are also directed to each individual feature, system, article, material, kit, and / or method described herein. Additionally, any combination of two or more such features, systems, articles, materials, kits, and / or methods is within the inventive scope of the present disclosure, provided that such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent.

[0048] The embodiments disclosed herein may also be combined with one or more features and complete systems, devices, and / or methods to yield still other embodiments and inventions. Also, some embodiments may be distinguishable from the prior art by specifically lacking one and / or another feature disclosed in a particular prior art reference, i.e., the claims to such embodiments are distinguishable from the prior art by including one or more negative limitations.

[0049] Also, various inventive concepts may be embodied as one or more methods. The acts performed as part of a method may be ordered in any suitable way. Thus, embodiments may be organized in which acts are performed in an order different from that illustrated, which may include performing some acts simultaneously.

[0050] The indefinite articles "a" and "an," as used herein in the specification and in the claims, should be understood to mean "at least one," unless expressly indicated otherwise. The terms "can" and "may" are used interchangeably in this disclosure to indicate that an element, component, structure, feature, functionality, purpose, advantage, operation, step, process, apparatus, system, device, result, or definite description reference has the ability to be used in, be included in, or produced by, or otherwise express the proposition set forth in the description in which the term is used (or referred to) with respect to a particular embodiment.

[0051] The term "and / or," as used herein in the specification and in the claims, should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and / or" should also be construed in the same manner, i.e., as "one or more" of the elements so conjoined. Other elements other than the elements specifically identified by the "and / or" clause may optionally be present, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to "A and / or B," when used in conjunction with open language such as "comprising," can, in one embodiment, refer to "A only" (optionally including elements other than B), in another embodiment to "B only" (optionally including elements other than A), and in yet another embodiment to "both A and B" (optionally including other elements), etc.

[0052] As used herein in the specification and in the claims, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also as including more than one of several elements or lists of elements, optionally including additional, unlisted items. Only terms clearly indicated to the contrary, such as "only one of," or "exactly one of," or, when used in the claims, "consisting of," will refer to the inclusion of exactly one element of several elements or lists of elements. In general, the term "or" as used herein, when preceded by terms of exclusivity such as "either," "one of," "only one of," or "exactly one of," shall be construed as indicating only exclusive alternatives (i.e., "one or the other but not both"). "Consisting essentially of," when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0053] As used herein within the specification and claims, the phrase "at least one," referring to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but does not necessarily include at least one of each and every element specifically listed in the list of elements, and does not exclude any combinations of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in the list of elements to which the phrase "at least one" refers, whether related or unrelated to those specifically identified elements. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B" or, equivalently, "at least one of A and / or B") can, in one embodiment, be "at least one, optionally including more than one, A, with no B present" (optionally including elements other than B), in another embodiment, "at least one, optionally including more than one, B, with no A present" (optionally including elements other than A), in yet another embodiment, "at least one, optionally including more than one, A" and "at least one, optionally including more than one, B (optionally, at least one B, including more than one)" (optionally, including other elements), etc.

[0054] In the claims and in the above specification, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like, are to be understood to be open-ended, i.e., meaning "including but not limited to." Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively, as set forth in the U.S. Patent Office Manual of Patent Examining Procedures, Section 2111.03.

Claims

1. 1. An anchoring device for reversibly retaining a catheter or tube within tissue, the device comprising a cylinder including a wall, an outer surface, and one or more prongs; Each claw is a portion thereof that is at least one of flexibly integral with and flexibly secured to at least one of the outer surface and the wall; configured to protrude away from the surface of the cylinder when in a deployed state; configured to roll or otherwise fold upon rotation of the cylinder in a first direction so that in an undeployed state it is at least one of immediately adjacent the outer surface and / or received by a recess or opening in at least one of the surface of the cylinder and a wall of the cylinder; Device.

2. The device of claim 1 , wherein the one or more claws comprise a plurality of claws.

3. The apparatus of claim 2 , wherein the plurality of claws are arranged around the circumference of the cylinder.

4. The apparatus of claim 2 , wherein the plurality of claws are evenly spaced around the circumference of the cylinder.

5. The device of claim 1 , wherein each prong is configured to be disposed within tissue.

6. The device of claim 1 , wherein each prong includes a surface area configured to assist in retaining at least one of a catheter and a needle within tissue.

7. 2. The device of claim 1, wherein each claw portion includes at least one of a height relative to a surface of the cylinder and an edge configured to interact with tissue to maintain at least a distal end of the catheter and / or needle within the tissue in response to an axial force being placed on the catheter / the catheter and / or needle in a proximal direction thereof.

8. 10. The device of claim 1, wherein each claw includes a barb configured to interact with tissue to retain the catheter and / or needle within the tissue and to prevent longitudinal movement of the catheter in at least a first direction.

9. The device of claim 1 , wherein each claw is configured as a propeller-like structure in the deployed state.

10. 10. The apparatus of claim 9, wherein the propeller-like structure is configured with a pitch of 1 to 90 degrees relative to the axis of the cylinder.

11. The device of claim 1 , wherein the one or more claws or plurality of claws comprises at least two claws.

12. The device of claim 1 , wherein the one or more claws or plurality of claws comprises at least three claws.

13. The device of claim 1 , wherein the one or more claws or plurality of claws comprises at least four claws.

14. 2. The device of claim 1, wherein the one or more claws or claws are arranged in one or more planes that lie at an angle to the longitudinal axis / axis of the cylinder, optionally the angle being perpendicular to the longitudinal axis.

15. 2. The device of claim 1, wherein the one or more claws or claws are arranged in one or more planes aligned with the longitudinal axis / the longitudinal axis of the cylinder.

16. 10. The apparatus of claim 1, wherein the one or more claws or claws are arranged in at least two planes that are arranged at an angle relative to the longitudinal axis of the cylinder.

17. The device of claim 1 , wherein the catheter includes one or more electrodes.

18. The device of claim 1 , wherein the catheter comprises a pulse generator.

19. 2. The device of claim 1, wherein the one or more claws or claws are arranged in at least two planes that lie at an angle to the longitudinal axis / axis of the cylinder, optionally the angle being perpendicular to the longitudinal axis.

20. the one or more claws or claws are arranged in at least two planes that lie at an angle to the longitudinal axis / the longitudinal axis of the cylinder; Optionally, the angle is perpendicular to the longitudinal axis; the barbs associated with the one or more prongs arranged in a first plane of the at least two planes are shaped and arranged to impede longitudinal movement of the catheter in a first direction; the barbs associated with the one or more prongs arranged in a second plane of the at least two planes are shaped and arranged to impede longitudinal movement of the catheter in a second direction opposite the first direction; 10. The apparatus of claim 1.

21. 1. A system for reversibly retaining a catheter in tissue, the system comprising: A device according to any one of claims 1 to 20; At least one of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire; A system comprising:

22. 1. A system for reversibly retaining a catheter in tissue, the system comprising: A device according to any one of claims 1 to 20; At least two of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire; A system comprising:

23. 1. A system for reversibly retaining a catheter in tissue, the system comprising: A device according to any one of claims 1 to 20; At least three of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire; A system comprising:

24. 1. A system for reversibly retaining a catheter in tissue, the system comprising: A device according to any one of claims 1 to 20; At least four of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire; A system comprising:

25. 1. A system for reversibly retaining at least one of a catheter and a needle within tissue, the system comprising: A device according to any one of claims 1 to 20; At least five of a catheter, a needle, an electrode, a liner extrusion, a jacket extrusion, and a conductor wire; A system comprising:

26. 1. A system for reversibly retaining at least one of a catheter and a needle within tissue, the system comprising: A device according to any one of claims 1 to 20; catheters, needles, electrodes, liner extrusions, jacket extrusions, and conductor wires A system comprising:

27. 1. A method for retaining a catheter in tissue, the method comprising: Providing an anchoring device according to any one of claims 1-20 or an anchoring system according to any one of claims 21-26, wherein the catheter and cylinder form an assembly; inserting the assembly through the surface of the insertion site toward a target area; rotating the cylinder in a first direction such that the one or more claws of the anchoring device are deployed within the tissue; rotating the cylinder in a second direction opposite the first direction so that the one or more claws of the mooring device are wrapped and / or otherwise folded so that they lie directly adjacent the outer surface of the cylinder and, optionally, are received by a recess or opening in at least one of the surface of the cylinder and a wall of the cylinder; A method comprising:

28. 1. A method for retaining at least one of a catheter and a needle within tissue, the method comprising: Providing a mooring device according to any one of claims 1-20 or a mooring system according to any one of claims 21-26, comprising: the catheter and cylinder form an assembly; the catheter including one or more electrodes for applying an electrical current to tissue; sterilizing the surface of the tissue at the insertion site; anesthetizing the surface at the insertion site with a local anesthetic; Optionally, inserting the assembly through the surface of the insertion site toward a target nerve under ultrasound imaging guidance; at least one of an ultrasound image produced by the ultrasound imaging guidance and eliciting appropriate muscle contractions of muscles adjacent to the target nerve via the one or more electrodes is configured to confirm that a portion of the catheter is adjacent to the target nerve. And, rotating the cylinder in a first direction such that the one or more claws of the anchoring device are deployed within the tissue; rotating the cylinder in a second direction opposite the first direction so that the one or more claws of the mooring device are wrapped and / or otherwise folded so that they lie directly adjacent the outer surface of the cylinder and, optionally, are received by a recess or opening in at least one of the surface of the cylinder and a wall of the cylinder; A method comprising:

29. 1. A method for use of a catheter pain management device or system, said method comprising: Providing a mooring device according to any one of claims 1-20 or a mooring system according to any one of claims 21-26, comprising: the catheter and cylinder, and optionally the needle, form an assembly; the catheter includes a portion containing the medical device for positioning and / or delivering the medical device adjacent to a particular area of ​​tissue; And, removably securing the needle to the catheter; connecting the needle to a pulse generator configured to deliver pulses of electrical current at a predetermined amperage, frequency, and / or duration; connecting tubing configured to communicate with the needle lumen to a syringe filled with a glucose solution; flushing the lumens of the tubing and needle to remove any air from the lumens of the tubing and needle; sterilizing the surface of the tissue at the insertion site; anesthetizing the surface at the insertion site with a local anesthetic; injecting a glucose solution through the needle to create an area of ​​fluid by hydrodissection adjacent to the target nerve; Optionally, inserting the assembly through the surface of the insertion site toward a target nerve under ultrasound imaging guidance; at least one of an ultrasound image produced by the ultrasound imaging guidance and eliciting appropriate muscle contractions of muscles adjacent to the target nerve via the one or more electrodes is configured to confirm that the tip of the needle is adjacent to the target nerve. And, unlocking the needle from the catheter; sliding the catheter a predetermined distance into the hydrodissected area adjacent the target nerve; removing the needle from the tissue; activating the pulse generator; Optionally, data-linking the pulse generator to a smart device configured to control the pulse generator via at least one of a dedicated application running on the smart device and a user interface thereof; establishing at least one of an inferior stimulation threshold current and an superior stimulation threshold current for the pulse generator using at least one of the dedicated application and user interface; rotating the cylinder in a first direction such that the one or more prongs of the anchoring device deploy within the tissue to retain at least the catheter within the tissue; sealing the surface of the insertion site with a surgical adhesive glue; applying a waterproof covering configured to cover the catheter outside the surface of the tissue so as to keep an injection port / hub of the catheter outside the waterproof covering; closing the injection port / hub with a clave; injecting a local anesthetic solution through the syringe to produce a primary nerve block; Attaching the clave with a luer lock component; and rotating the cylinder in a second direction opposite the first direction so that the one or more prongs of the anchoring device are wrapped or otherwise folded so that they lie directly adjacent the outer surface of the cylinder and, optionally, are received by a recess or opening in at least one of the surface of the cylinder and a wall of the cylinder, to remove the catheter. A method comprising:

30. A method, system, apparatus, or device according to any one or more of the embodiments disclosed herein.

Images