Subcutaneous measurement and dissection tool

Abstract

A dissection tool comprising: a first elongated body; a slot extending through the first elongated body, wherein when the first elongated body is aligned with a medial malleolus and an Achilles tendon of a patient, a distal end of the slot at least partially defines a location for an incision site on the patient; and a second elongated body connected to the first elongated body, wherein the second elongated body is configured to be inserted into an incision at the incision site to define a subcutaneous pocket around a tibial nerve of the patient.

Description

Docket No.: A0007520W001SUBCUTANEOUS MEASUREMENT AND DISSECTION TOOLCROSS RELATED REFERENCE

[0001] This application is a PCT application that claims priority to, and the benefit of, U.S. Provisional Patent Application No. 63 / 748,626, filed January 23, 2025, the entire contents of which is incorporated herein by reference.TECHNICAL FIELD

[0002] The disclosure relates generally to medical device systems and, more particularly, systems for inserting medical devices.BACKGROUND

[0003] Some types of medical device systems may be configured to monitor one or more physiological parameters of a patient and / or deliver electrical signals to nerve(s) of the patient. Such medical device systems may include one or more sensors that detect signals associated with physiological parameters of a patient. Such medical device systems may include one or more electrodes that deliver electrical signals to one or more nerves of the patient. These medical devices may be implanted subcutaneously within the patient.SUMMARY

[0004] In general, the disclosure is directed to a tool configured to facilitate implantation of an implantable medical device (IMD) at or around an ankle of a patient (e.g., within a talocrural region of the patient). The IMD may be configured to sense physiological signals from and / or deliver electrical signals to nerve(s) of the patient. In some examples, the IMD is configured to deliver electrical signals to a tibial nerve of the patient, e.g., to deliver tibial nerve stimulation (TNS) therapy to the patient.

[0005] The IMD may be implanted next to the tibial nerve of the patient within a subcutaneous pocket at or around the ankle of the patient. A clinician may use the example tool described herein to identify an incision site at or around the ankle of the patient based on anatomical markers. After the clinician makes an incision at the identified incision site, the clinician may insert the same tool through the incision to form the subcutaneous pocket via dissection. The example tool may be used to identify an incision site based on anatomical markers, e.g., to place IMD at an optimal subcutaneous location for the delivery of electrical signals. The example tool may be used to both identify the incision site and to dissect tissueDocket No.: A0007520W001within the incision to form the subcutaneous pocket, which may simplify and shorten the implantation procedure for the IMD.

[0006] In some examples, this disclosure is directed to a dissection tool comprising: a first elongated body; a slot extending through the first elongated body, wherein when the first elongated body is aligned with a medial malleolus and an Achilles tendon of a patient, a distal end of the slot at least partially defines a location for an incision site on the patient; and a second elongated body connected to the first elongated body, wherein the second elongated body is configured to be inserted into an incision at the incision site to define a subcutaneous pocket around a tibial nerve of the patient.

[0007] In some examples, this disclosure is directed to a method comprising: aligning a first elongated body of a dissection tool with a medial malleolus and an Achilles tendon of a patient; marking, based at least in part on a position of one or more reference features on the first elongated body, an incision site on the patient; making an incision along the incision site; and inserting a second elongated body of the dissection tool into the incision to form a subcutaneous pocket around a tibial nerve of the patient, wherein the second elongated body is connected to the first elongated body.

[0008] In some examples, this disclosure is directed to a dissection tool comprising: a first elongated body; a slot extending through the first elongated body; one or more reference features on the first elongated body; and a second elongated body connected to and extending orthogonally from the first elongated body, wherein when the first elongated body is aligned with a medial malleolus and an Achilles tendon of a patient, the slot and the one or more reference features define a location for an incision site on the patient, and wherein the second elongated body is configured to be inserted into an incision at the incision site to define a subcutaneous pocket around a tibial nerve of the patient.

[0009] The summary is intended to provide an overview of the subject matter described in this disclosure. It is not intended to provide an exclusive or exhaustive explanation of the systems, device, and methods described in detail within the accompanying drawings and description below. Further details of one or more examples of this disclosure are set forth in the accompanying drawings and in the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0010] FIG. l is a conceptual diagram illustrating an example dissection tool, in accordance with one or more techniques of this disclosure.Docket No.: A0007520W001

[0011] FIG. 2 is an anatomical diagram illustrating an ankle of a patient.

[0012] FIG. 3 A is a conceptual diagram illustrating a dissection portion of the dissection tool of FIG. 1.

[0013] FIG. 3B is a conceptual diagram illustrating a side view of the dissection tool of FIG.1.

[0014] FIG. 3C is a conceptual diagram illustrating a measurement portion of the dissection tool of FIG. 1.

[0015] FIG. 4A is a conceptual diagram illustrating anatomical markers on the ankle of the patient.

[0016] FIG. 4B is a conceptual diagram illustrating a clinician aligning an example dissection tool with the anatomical markers of FIG. 4A.

[0017] FIG. 4C is a conceptual diagram illustrating a clinician marking reference markings on the ankle of the patient using the dissection tool.

[0018] FIG. 4D is a conceptual diagram illustrating a clinician marking an incision site on the ankle of the patient based on the reference markings of FIG. 4C.

[0019] FIG. 5A is a conceptual diagram illustrating a clinician forming a subcutaneous pocket at the incision site using the dissection tool.

[0020] FIG. 5B is a conceptual diagram illustrating a side view of the dissection tool within the subcutaneous pocket.

[0021] FIG. 6 is a flow chart illustrating an example process for implanting an IMD within the patient using the dissection tool.DETAILED DESCRIPTION

[0022] This disclosure describes techniques for placing an IMD under the skin of a patient using an example dissection tool. The IMD may record one or more biometric signals of a patient and / or may deliver electrical signals to nerve(s) of the patient. In some examples, the IMD is configured to be implanted within a subcutaneous pocket at or around an ankle of the patient. Within the subcutaneous pocket, the IMD may be placed next to a target nerve of the patient (e.g., a tibial nerve of the patient) and may sense electrical signals from and / or deliver electrical signals to the target nerve.

[0023] FIG. 1 is a conceptual diagram illustrating an example dissection tool 100, in accordance with one or more techniques of this disclosure. Dissection tool 100 may include a dissection portion 102 and a measurement portion 104. Dissection portion 102 may be connected to measurement portion 104 via an intermediate portion 106. Measurement portion 104 may beDocket No.: A0007520W001alternatively referred to herein as “first portion 104” and dissection portion 102 may be alternatively referred to herein as “second portion 102”.

[0024] Measurement portion 104 may include slot 110 extending through measurement portion 104. Measurement portion 104 may define one or more reference features 112, e.g., along one or more edges of measurement portion 104. Measurement portion 104 may be configured to be aligned relative to anatomical marker(s) on the patient. When measurement portion 104 is aligned relative to the anatomical marker(s), a clinician may use reference feature(s) 112 to mark an incision line on the skin of the patient. The clinician may then create an incision along the incision line.

[0025] Dissection portion 102 may extend orthogonally relative to measurement portion 104. Dissection portion 102 may define a distal end 108. Dissection portion 102 is configured to be inserted into the body of the patient through an incision along the incision line. Within the incision, distal end 108 of dissection portion 102 may form a subcutaneous pocket, e.g., via dissection of tissue of the patient. Dissection portion 102 may be sized to form a subcutaneous pocket with dimensions less than or equal to corresponding dimensions of the IMD. Distal end 108 may define a blunt tip, e.g., to enable blunt dissection of the tissue.

[0026] Intermediate portion 106 may connect measurement portion 104 to dissection portion 102. Intermediate portion 106 may be curved. When dissection portion 102 is inserted within the incision, intermediate portion 106 may interface with patient tissue, e.g., to inhibit overtravel of dissection portion 102 within the incision.

[0027] Dissection tool 100 may be formed from a single component or may be formed from two or more separate components. Dissection tool 100 may be formed from one or more biocompatible materials including, but is not limited to, stainless steel, a biocompatible metallic alloy, or a biocompatible polymer.

[0028] FIG. 2 is an anatomical diagram illustrating an ankle 200 of a patient. As illustrated in FIG. 2, ankle 200 may include flexor digitorum longus muscle 204, tibialis posterior muscle 206, flexor retinaculum 208, posterior tibial vein 210, posterior tibial artery 212, tibial nerve 214, flexor hallucis longus muscle 216, and Achilles tendon 218.

[0029] As illustrated in FIG. 2, IMD 202 may be disposed within a subcutaneous pocket next to tibial nerve 214. IMD 202 may be placed inward of Achilles tendon 218 of the patient (e.g., inward of an anterior border of Achilles tendon 218). IMD 202 may be configured to sense electrical signals from and / or deliver electrical signals to tibial nerve 214.

[0030] FIG. 3 A is a conceptual diagram illustrating dissection portion 102 of dissection tool 100 of FIG. 1. An elongated body 302 of dissection portion 102 may extend along longitudinalDocket No.: A0007520W001axis 301 from base 304 to distal end 108. Distal end 108 may define a distal tip 306 and rounded edges 308 around distal tip 306. Together, distal tip 306 and rounded edges 308 may define a blunt dissection tip of dissection portion 102. When dissection portion 102 is inserted into an incision on the body of the patient, distal tip 306 and rounded edges 308 may separate tissue (e.g., via blunt dissection) without penetrating patient tissue, posterior tibial vein 210, posterior tibial artery 212, and / or tibial nerve 214. Each rounded edge 308 may define a radius of curvature of up to about 0.025 centimeters (cm) (e.g., up to about 0.01 inches (in)).

[0031] Elongated body 302 may define a length 312 from base 304 to distal tip 306. Base 304 may be a lower outer surface of measurement portion 104 of dissection tool 100. Elongated body 302 may define a width 310. The dimensions of elongated body 302 may be less than or equal to corresponding dimensions of IMD 202, e.g., to inhibit unintended movement of IMD 202 within the subcutaneous pocket formed by elongated body 302. For example, length 312 may be less than or equal to a corresponding length of IMD 202. In another example, width 310 may be less than or equal to a corresponding width of IMD 202. Length 312 may be up to about 5 cm (e.g., up to about 0.4 in). Width 310 may be up to about 1.4 cm (e.g., up to about 0.55 in).Elongated body 302 may define a uniform or varied width 310 along the length of elongated body 302. Length 312 and width 310 may vary based on the dimensions of IMD 202. For example, an example delivery tool 100 with elongated body 302 with a longer length 312 may be used to implant a longer IMD 202. In another example, an example deliver tool 100 with elongated body 302 with an increased width 312 may be used to implant a wider IMD 202.

[0032] FIG. 3B is a conceptual diagram illustrating a side view of dissection tool 100 of FIG.1. As illustrated in FIG. 3B, elongated body 302 may define outer surfaces 315, 316. Distal end 108 may define a curvature 314 extending from first outer surface 316 to a second outer surface 315. Distal tip 306 and / or rounded edges 308 may define curvature 314. Curvature 314 may define a radius of curvature greater than or equal to about 0.64 cm (e.g., greater than or equal to about 0.25 in). Dissection portion 102 may define a thickness 317. Thickness 317 may be uniform or may be varied along length 312 of elongated body 302. Thickness 317 may be about 0.25 cm (e.g., about 0.1 in).

[0033] Intermediate portion 106 may connect elongated body 302 of dissection portion 102 to elongated body 320 of measurement portion 104. Elongated body 320 may extend along longitudinal axis 321. Intermediate portion 106 may define an angle 318 between elongated body 302 and elongated body 320. Angle 318 may be at least 90 degrees.

[0034] Elongated body 320 may define first outer surface 322 and second outer surface 323. Second outer surface 323 may be configured to be placed in contact with the skin of the patient.Docket No.: A0007520W001Second outer surface 323 may define base 304 of dissection portion 102. Second outer surface 323 may define one or more features (e.g., protrusions, recesses, texturing) to inhibit unintended movement of dissection tool 100 along skin of the patient when the clinician places dissection tool 100 over the skin of the patient.

[0035] Elongated body 320 may define length 326 along longitudinal axis 321. Length 326 may be measured from distal end 324 of elongated body 320 to a base of elongated body 320. Second outer surface 315 may define the base of elongated body 320. Length 326 may be up to about 11.4 cm (e.g., up to about 4.5 in). Elongated body 320 may define thickness 328 from first outer surface 322 to second outer surface 323. Thickness 328 may be uniform or may be varied along length 326. Thickness 328 may be the same as or different from (e.g., greater than) thickness 317 of dissection portion 102. Thickness 328 may be about 0.25 cm (e.g., about 0.1 in).

[0036] FIG. 3C is a conceptual diagram illustrating measurement portion 104 of dissection tool 100 of FIG. 1. As illustrated in FIG. 3C, elongated body 320 may extend along longitudinal axis 321 from the base (e.g., from second outer surface 315 of dissection portion 102) to distal end 324. Elongated body 320 may define a first edge 334A and a second edge 334B (collectively referred to herein as “edges 334”). First edge 334A may be alternatively referred to herein as an “anterior edge 334A” of elongated body 320. Second edge 334B may be alternatively referred to herein as a “posterior edge 334B” of elongated body 320.

[0037] Elongated body 320 may define a first portion 322A and a second portion 322B. First portion 322A may be closer to distal end 324 than second portion 322B. First portion 322A may include slot 110 and reference feature(s) 112. First portion 322A may define a width 342 different from (e.g., greater than) the width of second portion 322B. The width of second portion 322B may be the same as width 310 of elongated body 302 of dissection portion 102. Width 342 may be up to 1.85 cm (e.g., up to 0.73 in). Width 342 may be greater than width 310, e.g., to provide sufficient width 340 between each edge of slot 110 and a nearest edge of edges 334 of first portion 332A of elongated body 320. Width 340 may be about 8 millimeters (mm) (e.g., about 0.31 in).

[0038] Slot 110 may extend along first portion 322A of elongated body 320 from first end 336A to second end 336B. Slot 110 may extend through elongated body 320, e.g., from first outer surface 322 to second outer surface 323. Slot 110 may define a length 346 between ends 336A, 336B of up to about 5 cm (e.g., up to about 1.97 in). Length 346 may be representative of a length of a subcutaneous pocket formed by dissection portion 102. Length 346 of slot 110 and length 312 of elongated body 302 may vary based on a length of IMD 202. Length 346 may be the same as length 312. Slot 110 may define a width such that the clinician may insert a markingDocket No.: A0007520W001implement (e.g., a pen, a marker) through slot 110 to contact and mark skin beneath elongated body 320. The width of slot 110 may be about 2.5 mm (e.g., about 0.1 in).

[0039] Slot 110 may define an arc around at each of first end 336A and second end 336B. First end 336A of slot 110 may be longitudinally aligned with the one or more reference feature(s) 112 along longitudinal axis 321. In some examples, as illustrated in FIG. 3C, a center of an arc defining first end 336A is aligned with reference feature(s) 112 along reference axis 338. In such examples, reference axis 338 may be orthogonal to longitudinal axis 321. Each reference feature 112 may indicate a marking location along one of edges 334. Each reference feature 112 may include, but is not limited to, a mark or other indicator on an outer surface of first portion 332A of elongated body 320 (e.g., on outer surface 322 of elongated body 320). In some examples, as illustrated in FIG. 3C, each reference feature 112 may include a cutout on one of edges 334. A width of the cutout may be the same as or greater than the width of slot 110.

[0040] A distance 344 along longitudinal axis 321 between second end 336B and second outer surface 315 may be about 4 cm (e.g., about 1.57 in). A distance 348 between first end 336A and outer surface 315 (e.g., between reference axis 338 and outer surface 315) may be about 9 cm (e.g., about 3.54 in). Distance 348 may be a sum of length 346 and distance 344. Distance 348 may be representative of a distance between an incision and an anatomical marker of the patient (e.g., the medial malleolus of the patient). Distance 348 may vary based on the dimensions of IMD 202.

[0041] FIG. 4A is a conceptual diagram illustrating anatomical markers on ankle 200 of the patient. The anatomical markers on ankle 200 may include, but are not limited to, medial malleolus 402 and Achilles tendon 218 of ankle 200. The clinician may identify the locations of medial malleolus 402 and Achilles tendon 218 within ankle 200. The clinician may make marks 404 and 406 on skin of ankle 200. First mark 404 may indicate a position of a feature of medial malleolus 402. For example, first mark 404 may correspond to a center of medial malleolus 402. Second mark 406 may indicate a position of a feature of Achilles tendon 218. For examples, second mark 406 may correspond to an anterior border of Achilles tendon 218, e.g., second mark 406 may define a line extending along the anterior border of Achilles tendon 218.

[0042] FIG. 4B is a conceptual diagram illustrating a clinician aligning example dissection tool 100 with the anatomical markers of FIG. 4 A. The clinician may make third mark 408 on skin of ankle 200 based on marks 404, 406 on ankle 200. Third mark 408 may define a line (e.g., a linear line) extending from first mark 404 and towards a posterior surface of ankle 200 (e.g., towards Achilles tendon 218). The line of third mark 408 may be orthogonal to or substantially orthogonal to a line of mark 406.Docket No.: A0007520W001

[0043] The clinician may place measurement portion 104 of dissection tool 100 over the skin of ankle 200. The clinician may place dissection tool 100 on the skin of ankle 200 such that dissection portion 102 extends away from ankle 200. In some examples, the clinician places second outer surface 323 of elongated body 320 in contact with the skin of ankle 200. Second outer surface 323 may interface with the skin to inhibit unintended movement of dissection tool 100 relative to the skin. The clinician may align dissection portion 102 and measurement portion 104 of dissection tool 100 with marks on ankle 200 (e.g., with first mark 404, second mark 406, and / or third mark 408).

[0044] The clinician may align dissection portion 102 with third mark 408. In some examples, the clinician aligns outer surface 315 of elongated body 302 of dissection portion 102 with third mark 408. In some examples, the clinician aligns intermediate portion 106 of dissection tool 100 (e.g., a center of intermediate portion 106) with third mark 408. The clinician may align first portion 322A of elongated body 320 of measurement portion 104 with second mark 406. For example, as illustrated in FIG. 4B, the clinician may align second edge 334B of first portion 322A with second mark 406. Aligning dissection portion 102 with third mark 408 and measurement portion 104 with second mark 406 may align slot 110 and reference feature(s) 112 with an incision site on ankle 200. The incision site may be used to form a subcutaneous pocket configured to retain IMD 202 within ankle 200, e.g., in the same or similar position illustrated in FIG. 2.

[0045] FIG. 4C is a conceptual diagram illustrating a clinician marking reference markings on ankle 200 of the patient using dissection tool 100. FIG. 4D is a conceptual diagram illustrating a clinician marking an incision site on the ankle of the patient based on the reference markings of FIG. 4C.

[0046] When dissection tool 100 is placed over ankle 200, the clinician may make (e.g., via a pen, via a marker) a fourth mark 410 on the skin through slot 110. Fourth mark 410 may extend along an entire length of slot 110, e.g., from first end 336A to second end 336B. Fourth mark 410 may be parallel to or substantially parallel to second mark 406. A distance between fourth mark 410 and second mark 406 may be greater than or equal to width 340 of measurement portion 104. Fourth mark 410 may be placed over tibial nerve 214.

[0047] The clinician may make one or more fifth marks 412 on the skin via reference feature(s) 112. The clinician may make up to two fifth marks 412. In some examples, where reference feature(s) 112 include markings or other indicators of first portion 322A, the clinician may make fifth marks 412 outside of edges 334 of elongated body 320 and in alignment with reference feature(s) 112 (e.g., along longitudinal axis 321 of elongated body 320). In someDocket No.: A0007520W001examples, as illustrated in FIG. 4C, wherein reference feature(s) 112 include cutouts on edges 334 of elongated body 320, the clinician may insert a marking implement into the cutouts to mark fifth marks 412. Fifth marks 412 may be aligned with an end of fourth mark 410 along reference axis 338.

[0048] Once the clinician makes fourth mark 410 and fifth marks 412, the clinician may remove dissection tool 100 from over ankle 200. The clinician may make sixth mark 414 to connect fourth mark 410 and fifth marks 412. Sixth mark 414 may define a line extending along reference axis 338. Sixth mark 414 may define an incision line for the clinician to make an incision during the implantation procedure for IMD 202. The dimensions of elongated body 320 of measurement portion 104 (e.g., distance 344, length 346 of slot 110, distance 348) may cause sixth mark 414 to be placed at a specific distance from one or more anatomical markers (e.g., from medial malleolus 402). The dimensions of elongated body 320 (e.g., width 340, width 342) may cause sixth mark 414 to define a specific length to allow insertion of IMD 202 into an incision made along sixth mark 414. A length of fourth mark 410 may be the same as length 346 of slot 110 and may correspond to the furthest position of dissection portion 102 within ankle 200 when the clinician inserts dissection portion 102 through an incision along sixth mark 414.

[0049] FIG. 5A is a conceptual diagram illustrating a clinician forming a subcutaneous pocket 506 at the incision site using dissection tool 100. FIG. 5B is a conceptual diagram illustrating a side view of dissection tool 100 within subcutaneous pocket 506.

[0050] The clinician may make incision 504 at the incision site on ankle 200. The incision site may be defined by fourth mark 410, fifth marks 412, and / or sixth mark 414. The clinician may make incision 504 along the length of sixth mark 414 (e.g., from one fifth mark 412 to an opposite fifth mark 412). Once the clinician makes incision 504, the clinician may insert dissection portion 102 into incision 504 to form subcutaneous pocket 506. Subcutaneous pocket 506 may define a width 512 equal to width 310 of elongated body 302 of dissection portion 102. Subcutaneous pocket 506 may define a length 514 equal to length 312 of elongated body 302 of dissection portion 102 (e.g., equal to a length of fourth mark 410). Subcutaneous pocket 506 may define a height 516 equal to thickness 317 of elongated body 302.

[0051] As dissection portion 102 enters beneath skin 502 of the patient via incision 504, distal end 108 may dissect tissue of the patient (e.g., subcutaneous fat 508 of the patient) do define subcutaneous pocket 506. Distal end 108 may define a blunt end and may dissect the tissue via blunt dissection. Dissection portion 102 may define subcutaneous pocket 506 between subcutaneous fat 508 and fascia 510 of the patient. Subcutaneous pocket 506 may be placed over tibial artery 212 and tibial nerve 214.Docket No.: A0007520W001

[0052] Intermediate portion 106 connecting distal portion 102 and measurement portion 104 may be curve and may define angle 318 separating distal portion 102 and measurement portion 104. The curvature of and / or angle 318 of intermediate portion 106 may inhibit overtravel of dissection portion 102 within tissue of the patient. For example, the dimensions of intermediate portion 106 may inhibit penetration of distal end 108 through fascia 510 and / or towards tibial artery 212 and / or tibial nerve 214 of the patient.

[0053] FIG. 6 is a flow chart illustrating an example process for implanting an IMD 202 within the patient using dissection tool 100. While the technique illustrated in FIG. 6 is primarily described with respect to dissection tool 100 of any of FIGS. 1-5B, the technique may be performed using any other example dissection tool described herein.

[0054] A clinician may position a first portion 104 (e.g., measurement portion 104) of dissection tool 100 over skin 502 of the patient (602). The clinician may mark on skin 502 one or more marks indicative anatomical markers of the patient. For example, the clinician may make first mark 404 on skin 502 indicating a center of medial malleolus 402 and a second mark 406 indicating an anterior border of Achilles tendon 218. The clinician may make a third mark 408 extending from first mark 404 towards second mark 406. Third mark 408 may define a line orthogonal to a line of second mark 406.

[0055] The clinician may align measurement portion 104 of dissection tool 100 with one or more of marks 404, 406, 408 and place measurement portion 104 (e.g., outer surface 323 of elongated body 320 of measurement portion 104) over skin 502. The clinician may align dissection portion 102 (e.g., outer surface 315 of elongated body 302) and / or intermediate portion 106 of dissection tool 100 with third mark 408. The clinician may align measurement portion 104 with second mark 406. For example, the clinician may align second edge 334B of elongated body 320 of measurement portion 104 with second mark 406.

[0056] The clinician may determine, using the first portion 104 of dissection tool 100, an incision site on skin 502 of the patient (604). With dissection tool 100 placed over skin 502 and aligned with marks (e.g., marks 404, 406, 408), the clinician may make fourth mark 410 on skin 502 through slot 110. The clinician may make fourth mark 410 from first end 336A of slot 110 to second end 336B of slot 110. The clinician may make one or more fifth marks 412 on skin 502 using reference feature(s) 112 on measurement portion 104. Fifth marks 412 may be aligned with one end of fourth mark 410 along reference axis 338. The clinician may make sixth mark 414 connecting fifth marks 412 and the one end of fourth mark 410. Fourth mark 410 and sixth mark 414 may define the incision site for subcutaneous pocket 506. Fourth mark 410 may illustrate a location and / or length 514 of subcutaneous pocket 506 to be formed by the clinician forDocket No.: A0007520W001placement of IMD 202. Sixth mark 414 may illustrate an incision line for incision 504 at the incision site.

[0057] The clinician may form an incision 504 at the incision site (606). The clinician may make incision 504 along sixth mark 414 using an incision tool. Incision 504 may extend along an entire length of sixth mark 414. For example, incision 504 may extend from one fifth mark 412 to an opposite fifth mark 412.

[0058] The clinician may insert second portion 102 (e.g., dissection portion 102) of dissection tool 100 into incision 504 to form subcutaneous pocket 506 (608). The clinician may dissect tissue of the patient (e.g., subcutaneous fat 508) within incision 504 to define subcutaneous pocket 506. Distal end 108 of dissection portion 102 may dissect the tissue to define subcutaneous pocket 506, e.g., via blunt dissection.

[0059] Dissection portion 102 may define the dimensions of subcutaneous pocket 506. For example, width 512 of subcutaneous pocket 506 may be about the same as width 310 of elongated body 302 of dissection portion 102. In some examples, length 514 of subcutaneous pocket 506 is about the same as length 312 of elongated body 302 of dissection portion 102. In some examples, height 516 is about the same as thickness 317 of elongated body 302.

[0060] The clinician may form subcutaneous pocket 506 between subcutaneous fat 508 and fascia 510. The clinician may place subcutaneous pocket 506 next to tibial artery 212 and tibial nerve 214. The clinician may use measurement portion 104 (e.g., as a handle) to control movement of dissection portion 102 within incision 504. A curvature of intermediate portion 106 connecting dissection portion 102 to measurement portion 104 may control insertion of dissection portion 102 into incision 504 and / or inhibit unintended penetration of dissection portion 102 through fascia 510 (e.g., towards tibial artery 212 and tibial nerve 214).

[0061] The clinician may insert IMD 202 into subcutaneous pocket 506 (610). The dimensions of subcutaneous pocket 506 may be smaller than the dimensions of IMD 202, e.g., to inhibit movement of IMD 202 within subcutaneous pocket 506. Once IMD 202 is disposed within subcutaneous pocket 506, the clinician may close incision 504 to contain IMD 202 within subcutaneous pocket 506.

[0062] This disclosure includes the following non-limiting examples.

[0063] Example 1 : a dissection tool comprising: a first elongated body; a slot extending through the first elongated body, wherein when the first elongated body is aligned with a medial malleolus and an Achilles tendon of a patient, a distal end of the slot at least partially defines a location for an incision site on the patient; and a second elongated body connected to the firstDocket No.: A0007520W001elongated body, wherein the second elongated body is configured to be inserted into an incision at the incision site to define a subcutaneous pocket around a tibial nerve of the patient.

[0064] Example 2: the dissection tool of example 1, wherein the first elongated body extends along a first reference axis, wherein the second elongated body extends along a second reference axis, and wherein the first reference axis is offset from the second reference axis by an angle of at least 90 degrees.

[0065] Example 3 : the dissection tool of example 2, wherein the offset angle between the first elongated body and the second elongated body inhibits overtravel of the dissection tool within the incision.

[0066] Example 4: the dissection tool of any of examples 1-3, wherein the second elongated body defines one or more of a width less than a width of an implantable medical device (IMD) configured to be implanted within the subcutaneous pocket; or a thickness less than a thickness of the IMD.

[0067] Example 5: the dissection tool of any of examples 1-4, wherein the second elongated body defines a blunt tip, and wherein when the second elongated body is inserted into the incision, the blunt tip is configured to form the subcutaneous pocket via blunt dissection.

[0068] Example 6: the dissection tool of any of examples 1-5, further comprising two reference features disposed on the first elongated body, wherein the two reference features are longitudinally aligned with the distal end of the slot, and wherein when the first elongated body is aligned with the medial malleolus and the Achilles tendon, a reference line extending through the two reference features and the distal end of the slot defines the incision site.

[0069] Example 7: the dissection tool of example 6, wherein each reference feature of the two reference features comprises: a marking on an edge of the first elongated body; or a cutout on the edge of the first elongated body.

[0070] Example 8: the dissection tool of any of examples 1-7, wherein when the first elongated body is aligned with the medial malleolus and the Achilles tendon, a proximal end of the first elongated body is aligned with a center of the medial malleolus and an edge of the first elongated body is aligned with an anterior border of the Achilles tendon.

[0071] Example 9: the dissection tool of example 8, wherein when the edge of the first elongated body is aligned with the anterior border of the Achilles tendon, a near-side edge of the slot is positioned at least 8 millimeters (mm) from the anterior border of the Achilles tendon.

[0072] Example 10: the dissection tool of any of examples 8 or 9, wherein when the edge of the first elongated body is aligned with the anterior border of the Achilles tendon, the slot is positioned over the tibial nerve of the patient.Docket No.: A0007520W001

[0073] Example 11 : the dissection tool of any of examples 1-10, wherein the first elongated body extends from a proximal end, and wherein the base comprises a surface of the second elongated body.

[0074] Example 12: the dissection tool of any of examples 1-11, wherein a distance between a proximal end of the first elongated body and a proximal end of the slot is about 4 centimeters (cm).

[0075] Example 13: the dissection tool of any of examples 1-12, wherein a distance between a proximal end of the slot and the distal end of the slot is about 5 centimeters (cm).

[0076] Example 14: a method comprising: aligning a first elongated body of a dissection tool with a medial malleolus and an Achilles tendon of a patient; marking, based at least in part on a position of one or more reference features on the first elongated body, an incision site on the patient; making an incision along the incision site; and inserting a second elongated body of the dissection tool into the incision to form a subcutaneous pocket around a tibial nerve of the patient, wherein the second elongated body is connected to the first elongated body.

[0077] Example 15: the method of example 14, wherein the first elongated body extends along a first reference axis, wherein the second elongated body extends along a second reference axis, and wherein the first reference axis is offset from the second reference axis by an angle of at least 90 degrees.

[0078] Example 16: the method of example 15, wherein during insertion the second elongated body of the dissection tool into the incision, the offset angle between the first elongated body and the second elongated body inhibits unintended overtravel of the dissection tool within the incision.

[0079] Example 17: the method of any of examples 14-16, further comprising: disposing an implantable medical device (IMD) within the subcutaneous pocket, wherein the second elongated body defines one or more of: a width less than a width of the IMD; or a thickness less than a thickness of the IMD.

[0080] Example 18: the method of any of examples 14-17, wherein the second elongated body defines a blunt tip, and wherein inserting the second elongated body of the dissection tool into the incision further comprises: defining the subcutaneous pocket using the blunt tip via blunt dissection.

[0081] Example 19: the method of any of examples 14-18, wherein marking the incision site on the patient comprises: marking, via the one or more reference features, a line on the patient, wherein the line defines the incision site.Docket No.: A0007520W001

[0082] Example 20: the method of example 19, wherein each reference feature of the one or more reference features comprises: a marking on an edge of the first elongated body; or a cutout on the edge of the first elongated body.

[0083] Example 21 : the method of any of examples 14-20, wherein aligning the first elongated body of with the medial malleolus and the Achilles tendon comprises: aligning a proximal end of the first elongated body with a center of the medial malleolus and an edge of the first elongated body with an anterior border of the Achilles tendon.

[0084] Example 22: the method of example 21, wherein when the edge of the first elongated body is aligned with the anterior border of the Achilles tendon, a near-side edge of the slot is positioned at least 8 millimeters (mm) from the anterior border of the Achilles tendon.

[0085] Example 23: the method of any of examples 21 or 22, wherein when the edge of the first elongated body is aligned with the anterior border of the Achilles tendon, the slot is positioned over the tibial nerve of the patient.

[0086] Example 24: the method of any of examples 14-23, wherein the first elongated body extends from a proximal end, and wherein the base comprises a surface of the second elongated body.

[0087] Example 25: the method of any of examples 14-24, wherein a distance between a proximal end of the first elongated body and a proximal end of the slot is about 4 centimeters (cm).

[0088] Example 26: the method of any of examples 14-25, wherein a distance between a proximal end of the slot and the distal end of the slot is about 5 centimeters (cm).

[0089] Example 27: a dissection tool comprising: a first elongated body; a slot extending through the first elongated body; one or more reference features on the first elongated body; and a second elongated body connected to and extending orthogonally from the first elongated body, wherein when the first elongated body is aligned with a medial malleolus and an Achilles tendon of a patient, the slot and the one or more reference features define a location for an incision site on the patient, and wherein the second elongated body is configured to be inserted into an incision at the incision site to define a subcutaneous pocket around a tibial nerve of the patient.

[0090] Example 28: the dissection tool of example 27, wherein the second elongated body defines one or more of: a width less than a width of an implantable medical device (IMD) configured to be implanted within the subcutaneous pocket; or a thickness less than a thickness of the IMD.Docket No.: A0007520W001

[0091] Example 29: the dissection tool of any of examples 27 or 28, wherein the second elongated body defines a blunt tip, and wherein when the second elongated body is inserted into the incision, the blunt tip is configured to form the subcutaneous pocket via blunt dissection.

[0092] Example 30: the dissection tool of any of examples 27-29, wherein each reference feature of the one or more reference features comprises: a marking on an edge of the first elongated body; or a cutout on the edge of the first elongated body.

[0093] Example 31 : the dissection tool of any of examples 27-30, wherein when the first elongated body is aligned with the medial malleolus and the Achilles tendon, a proximal end of the first elongated body is aligned with a center of the medial malleolus and an edge of the first elongated body is aligned with an anterior border of the Achilles tendon.

[0094] Example 32: the dissection tool of example 31, wherein when the edge of the first elongated body is aligned with the anterior border of the Achilles tendon, a near-side edge of the slot is positioned at least 8 millimeters (mm) from the anterior border of the Achilles tendon.

[0095] Example 33 : the dissection tool of any of examples 31 or 32, wherein when the edge of the first elongated body is aligned with the anterior border of the Achilles tendon, the slot is positioned over the tibial nerve of the patient.

[0096] Various examples have been described herein. Any combination of the described operations or functions is contemplated. These and other examples are within the scope of the following claims. Based upon the above discussion and illustrations, it is recognized that various modifications and changes may be made to the disclosed examples in a manner that does not require strictly adherence to the examples and applications illustrated and described herein. Such modifications do not depart from the true spirit and scope of various aspects of the disclosure, including aspects set forth in the claims.

Claims

Docket No.: A0007520W001CLAIMS WHAT IS CLAIMED IS:

1. A dissection tool comprising:a first elongated body;a slot extending through the first elongated body, wherein when the first elongated body is aligned with a medial malleolus and an Achilles tendon of a patient, a distal end of the slot at least partially defines a location for an incision site on the patient; anda second elongated body connected to the first elongated body, wherein the second elongated body is configured to be inserted into an incision at the incision site to define a subcutaneous pocket around a tibial nerve of the patient.

2. The dissection tool of claim 1, wherein the first elongated body extends along a first reference axis, wherein the second elongated body extends along a second reference axis, and wherein the first reference axis is offset from the second reference axis by an angle of at least 90 degrees.

3. The dissection tool of claim 2, wherein the offset angle between the first elongated body and the second elongated body inhibits overtravel of the dissection tool within the incision.

4. The dissection tool of any of claims 1-3, wherein the second elongated body defines one or more of:a width less than a width of an implantable medical device (IMD) configured to be implanted within the subcutaneous pocket; ora thickness less than a thickness of the IMD.

5. The dissection tool of any of claims 1-4, wherein the second elongated body defines a blunt tip, and wherein when the second elongated body is inserted into the incision, the blunt tip is configured to form the subcutaneous pocket via blunt dissection.

6. The dissection tool of any of claims 1-5, further comprising two reference features disposed on the first elongated body, wherein the two reference features are longitudinally aligned with the distal end of the slot, and wherein when the first elongated bodyDocket No.: A0007520W001is aligned with the medial malleolus and the Achilles tendon, a reference line extending through the two reference features and the distal end of the slot defines the incision site.

7. The dissection tool of claim 6, wherein each reference feature of the two reference features comprises:a marking on an edge of the first elongated body; ora cutout on the edge of the first elongated body.

8. The dissection tool of any of claims 1-7, wherein when the first elongated body is aligned with the medial malleolus and the Achilles tendon, a proximal end of the first elongated body is aligned with a center of the medial malleolus and an edge of the first elongated body is aligned with an anterior border of the Achilles tendon.

9. The dissection tool of claim 8, wherein when the edge of the first elongated body is aligned with the anterior border of the Achilles tendon, a near-side edge of the slot is positioned at least 8 millimeters (mm) from the anterior border of the Achilles tendon.

10. The dissection tool of any of claims 8 or 9, wherein when the edge of the first elongated body is aligned with the anterior border of the Achilles tendon, the slot is positioned over the tibial nerve of the patient.

11. The dissection tool of any of claims 1-10, wherein the first elongated body extends from a proximal end, and wherein the base comprises a surface of the second elongated body.

12. The dissection tool of any of claims 1-11, wherein a distance between a proximal end of the first elongated body and a proximal end of the slot is about 4 centimeters (cm).

13. The dissection tool of any of claims 1-12, wherein a distance between a proximal end of the slot and the distal end of the slot is about 5 centimeters (cm).

14. A dissection tool comprising:a first elongated body;Docket No.: A0007520W001a slot extending through the first elongated body;one or more reference features on the first elongated body; anda second elongated body connected to and extending orthogonally from the first elongated body,wherein when the first elongated body is aligned with a medial malleolus and an Achilles tendon of a patient, the slot and the one or more reference features define a location for an incision site on the patient, andwherein the second elongated body is configured to be inserted into an incision at the incision site to define a subcutaneous pocket around a tibial nerve of the patient.

15. The dissection tool of claim 14, wherein when the first elongated body is aligned with the medial malleolus and the Achilles tendon, a proximal end of the first elongated body is aligned with a center of the medial malleolus and an edge of the first elongated body is aligned with an anterior border of the Achilles tendon.

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