# US 11,998,233 B2 · Directional device for epidural needle > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,233 B2 - Document ID: US11998233B2 - Status: Granted - Kind: B2 - Application number: 17/113,232 - Filed: 2020-12-07 - Published: 2022-06-09 - Granted: 2024-06-04 - Earliest claimed: 2020-12-07 - Assignees: Spiro Medical, Inc. - Applicants: Spiro Medical, Inc. - Inventors: Stephen T. Pyles - Web page: https://patentgrep.com/patent/US11998233B2 ## CPC - A61B 17/3403: {Needle locating or guiding means} - A61B 17/3401: {Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia} - A61B 90/37: {Surgical systems with images on a monitor during operation} - A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers} - A61B 2017/3407: {including a base for support on the body} - A61B 2017/3411: {with a plurality of holes, e.g. holes in matrix arrangement} - A61B 2090/376: {using X-rays, e.g. fluoroscopy} - A61B 2090/3937: {Visible markers} - A61B 2090/395: {with marking agent for marking skin or other tissue} - A61B 2090/3966: {Radiopaque markers visible in an X-ray image} - A61N 1/0551: {Spinal or peripheral nerve electrodes} - A61N 1/36062: {Spinal stimulation} - A61N 1/36071: {Pain} - A61N 1/372: Arrangements in connection with the implantation of stimulators - A61N 1/37241: {providing test stimulations} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract A device is described for marking a path on a skin surface for inserting an epidural needle into an epidural space. The device includes a first arm having one or more holes spaced apart along the length of the first arm. A pin is attached at the proximal end of the first arm. A second arm has a proximal end attached to the pin allowing the first and second arms to rotate about the pin to adjust an angle separating the first and second arms. The second arm has one or more holes spaced apart along the length of the second arm. The holes on the first and second arms provide locations for marking the path on the skin surface to insert the epidural needle. ## Claims ### Claim 1 A device for marking a path on a skin surface for inserting an epidural needle into an epidural space, the device comprising: a first arm having a length extending between a proximal end and a distal end, and a first plurality of holes equally spaced apart by a fixed distance along the length of the first arm; a pin attached at the proximal end of the first arm, wherein the pin is a hollow cylinder made from a material that is visible in fluoroscopy imaging for providing a fixed reference point that identifies a selected target location in the epidural space; and a second arm having a proximal end attached to the pin allowing the first and second arms to rotate about the pin to adjust an angle separating the first and second arms, and further having a length extending from the proximal end to a distal end, and a second plurality of holes equally spaced apart by the fixed distance along the length of the second arm; wherein the first and second pluralities of holes on the first and second arms provide locations for marking the path on the skin surface to insert the epidural needle; and wherein the first and second arms include the material surrounding each hole of the first and second pluralities of holes causing the first and second pluralities of holes to visually depict a path in the fluoroscopy imaging for inserting the epidural needle to reach the selected target location identified by the pin. ### Claim 2 (depends on 1) The device of claim 1, wherein the first and second arms are rotatable about the pin between closed and opened positions, the first and second arms when in the closed position are separated by 0 degrees, the first and second arms when in the opened position are separated by 180 degrees, and the angle separating the first and second arms is adjustable between 0 and 180 degrees for marking the path on the skin surface to insert the epidural needle. ### Claim 3 (depends on 1) The device of claim 1, wherein the first and second pluralities of holes on the first and second arms are aligned when the angle separating the first and second arms is 0 degrees. ### Claim 4 (depends on 1) The device of claim 1, wherein the length of the first arm is about is about 10 cm to about 14 cm long, and the length of the second arm is about is about 10 cm to about 14 cm long. ### Claim 5 (depends on 1) The device of claim 1, wherein the lengths of the first and second arms are equal. ### Claim 6 (depends on 1) The device of claim 1, wherein the first and second arms are made from a material that is not visible in fluoroscopy imaging. ### Claim 7 (depends on 1) The device of claim 1, wherein the first and second pluralities of holes on the first and second arms provide locations for marking a V shape pattern on the skin surface. ### Claim 8 (depends on 1) The device of claim 1, wherein each hole of the first and second pluralities of holes includes a grommet. ### Claim 9 A kit for marking a path on a skin surface for inserting an epidural needle into an epidural space, the kit comprising: a writing instrument; and a device comprising: a first arm having a length extending between a proximal end and a distal end, and a first plurality of holes equally spaced apart by a fixed distance along the length of the first arm; a pin attached at the proximal end of the first arm, wherein the pin is a hollow cylinder made from a material that is visible in fluoroscopy imaging for providing a fixed reference point that identifies a selected target location in the epidural space; and a second arm having a proximal end attached to the pin allowing the first and second arms to rotate about the pin to adjust an angle separating the first and second arms, and further having a length extending from the proximal end to a distal end, and a second plurality of holes equally spaced apart by the fixed distance along the length of the second arm; wherein the first and second pluralities of holes on the first and second arms provide locations for using the writing instrument to mark the path on the skin surface to insert the epidural needle; and wherein the first and second arms include the material surrounding each hole of the first and second pluralities of holes causing the first and second pluralities of holes to visually depict a path in the fluoroscopy imaging for inserting the epidural needle to reach the selected target location identified by the pin. ### Claim 10 (depends on 9) The kit of claim 9, further comprising the epidural needle. ### Claim 11 (depends on 9) The kit of claim 9, wherein the first and second pluralities of holes on the first and second arms provide locations for using the writing instrument to mark a V shape pattern on the skin surface. ### Claim 12 A method of using a device to prepare a patient for implantation of a lead for spinal cord stimulation, the method comprising: positioning a pin hole of the device over a target location for implanting the lead, the pin hole including a material visible in fluoroscopy imaging for identifying the target location; adjusting an angle separating first and second arms of the device to define a path for inserting an epidural needle to reach an epidural space of the target location, proximal ends of the first and second arms being attached to the pin hole; inserting a writing instrument into one or more holes on the first and second arms of the device to mark the path on a skin surface of the patient; and inserting the epidural needle into a hole on the first arm or second arm, the hole allowing the epidural needle to advance at an angle of 30 degrees toward a spinal lamina identified by the pin hole at the target location. ### Claim 13 (depends on 12) The method of claim 12, wherein the target location is a T11/T12 interlaminar space or a T12/L1 interlaminar space. ### Claim 14 (depends on 12) The method of claim 12, further comprising marking a V shape pattern on the skin surface for inserting two leads for the spinal cord stimulation. ### Claim 15 (depends on 12) The method of claim 12, further comprising inserting the writing instrument into the pin hole of the device to mark the target location on the skin surface. ### Claim 16 (depends on 12) The method of claim 12, wherein inserting the writing instrument into the one or more holes on the first and second arms of the device includes drawing a plurality of dots for marking the path on the skin surface for inserting the epidural needle.