System for placing medical device comprising inflatable balloon

Abstract

An implant tool system includes an implantable medical device. The implantable medical device includes regional visual indicia positioned on an outer surface of the device. The regional visual indicia includes a distal end of the regional visual indicia. Alignment of the distal end of the regional visual marker with the proximal end of the introducer indicates when to retrieve the introducer. The regional visual indicia also includes a proximal end of the regional visual indicia. Alignment of the proximal end of the zone visual marker with the proximal end of the introducer indicates when to inflate a balloon carried by the device and attach the distal end of the implantable medical device to a target site via a fixation mechanism.

Description

[0001] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 369,628, filed on July 27, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present disclosure generally relates to tool systems for implanting medical devices. Background Art

[0003] Some types of implantable medical devices (IMDs), such as pacemakers or implantable cardioverter-defibrillator systems, can be used to provide sensing and therapy to a patient via one or more electrodes. Some IMDs include one or more implantable medical electrical leads that include one or more electrodes. The leads can be configured so that the electrodes can be implanted at a target location for sensing and / or therapy, such as within the heart (e.g., a transvenous lead) or outside the heart and vascular system (e.g., an extravascular lead) for cardiac sensing and / or therapy. Once the leads are implanted, a tine or other fixing element attached to various locations of the leads can be deployed to prevent the leads from deflecting or moving. Summary of the invention

[0004] In some examples, an implant tool system includes: an implantable medical device sized to be inserted from a proximal end of an introducer through a lumen of the introducer to a distal end of the introducer, wherein the implantable medical device includes: a device body extending from the proximal end of the implantable medical device to the distal end of the implantable medical device; a balloon mechanically supported by the device body; a fixing mechanism configured to attach the distal end of the implantable medical device to a target site within the patient's body; and a regional visual marker positioned on an outer surface of the device body, the regional visual marker including: a distal end of the regional visual marker, wherein the distal end of the regional visual marker is aligned with the proximal end of the introducer to indicate when to retract the introducer; and a proximal end of the regional visual marker, wherein the proximal end of the regional visual marker is aligned with the proximal end of the introducer to indicate when to inflate the balloon and attach the distal end of the implantable medical device to the target site via the fixing mechanism.

[0005] In some examples, a method includes: inserting an introducer through an entry point on a patient's body, wherein the introducer defines a lumen extending from a proximal end of the introducer to a distal end of the introducer; inserting an implantable medical device through the lumen until a distal end of a regional visual marker positioned on an outer surface of a device body of the implantable medical device is aligned with the proximal end of the introducer; retracting the introducer at least until the proximal end of the regional visual marker is aligned with the proximal end of the introducer; inflating a balloon mechanically supported by the device body; and attaching the distal end of the implantable medical device to a target site within the patient's body via a fixation mechanism.

[0006] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1A is a conceptual diagram illustrating an example implant tool system including regional visual markings in accordance with the techniques of this disclosure.

[0008] Figure 1B is a conceptual diagram illustrating an example implantable medical balloon lead and an example introducer according to the presently disclosed technology.

[0009] Figure 2 is a conceptual diagram illustrating an example implantable medical balloon lead and an example introducer according to the presently disclosed technology.

[0010] Figure 3 is a conceptual diagram illustrating an example implantable medical lead in accordance with the presently disclosed technology.

[0011] Figure 4 is a flow chart of an example technique for delivering a lead of appropriate length into a patient's body.

[0012] Figure 5 is a flow chart of an example technique for delivering a lead of appropriate length into a patient's body. DETAILED DESCRIPTION

[0013] During implantation of an implantable lead including an inflatable balloon, a clinician may use a sheath introducer ("introducer") to gain access to the vasculature of the IMD into the patient's system. As part of the procedure, the clinician may advance the distal end of the lead supporting the balloon beyond the distal end of the introducer so that the balloon may be properly inflated (e.g., without damaging the balloon). To visualize the lead, the clinician may use fluoroscopic imaging to determine when the balloon has been advanced beyond the distal end of the introducer.

[0014] In the event that the distal end of the lead needs to be retracted into the introducer (e.g., to inspect the balloon), the balloon may need to be deflated before being pulled into the introducer; otherwise, the balloon may be damaged. Determining the position of the inflated balloon relative to the introducer may be difficult and often requires the additional use of fluoroscopic imaging, which may be detrimental to the patient's health.

[0015] According to the technology of the present disclosure, the lead can include one or more visual markers that indicate the position of the lead relative to the introducer without using visualization techniques (such as fluoroscopy) that may adversely affect the patient. The lead can support the visual marker. When outside the patient's body, the visual marker can be visible to the naked eye; when inside the patient's body, the visual marker can be visible in ultrasound and other imaging techniques, with less risk to the patient than fluoroscopy. In this way, the technology of the present disclosure can provide information to help clinicians implant leads more safely and consistently.

[0016] Figure 1A to Figure 1B 1 is a conceptual diagram of an example implantation tool system 100 ("system 100") for implanting an implantable medical device (IMD), such as an implantable medical balloon lead 102 ("lead 102"), into a patient 104. Figure 1A to Figure 1B As shown in FIG. 1 , system 100 includes a lead 102 and a sheath introducer 106 ("introducer 106") for providing pacing therapy.

[0017] Some of the components of the system 100 described herein, such as one or more visual markers, can be utilized with other types of implant tool systems, such as an implant tool system for delivering an IMD that is configured to deliver electrotherapy other than cardiac electrotherapy. For example, the technology of the present disclosure may be applied to non-cardiac situations, such as neurostimulation. In addition, although primarily described herein as implantable medical leads (e.g., cardiac leads), the IMD may be another type of device, such as a catheter. In addition, it should be noted that the system 100 may not be limited to the treatment of human patients. The system 100 may be implemented in non-human patients, such as primates, canines, equines, pigs, sheep, cattle, felines, and the like. These non-human patients may be undergoing clinical or research therapies that may benefit from the subject matter of the present disclosure.

[0018] Typically, a clinician may insert lead 102 through the patient's vasculature to a target site within the body of patient 104 (e.g., tissue of heart 108 of patient 104), where a medical procedure may be performed. Lead 102 may have a proximal end 110 ("lead proximal end 110") and a distal end 112 ("lead distal end 112"). Lead 102 may be temporary (e.g., lead 102 may be a temporary pacing balloon lead) or permanent. The length of lead 102 may vary. In some examples, lead 102 may be approximately 100 centimeters (cm).

[0019] The introducer 106 may have a proximal end 114 ("introducer proximal end 114") and a distal end 116 ("introducer distal end 116"). The introducer 106 may define a lumen 118 extending from the introducer proximal end 114 to the introducer distal end 116. The lumen 118 is sized to allow the guide wire 102 to be inserted from the introducer proximal end 114 through the lumen 118 to the introducer distal end 116. The length of the introducer 106 may vary. In some examples, the length of the introducer 106 may be between approximately 10 cm and 25 cm. The introducer proximal end 114 may be exposed at the entry point 120. That is, a portion of the introducer 106 may be in vivo, while the remainder of the introducer 106 may be in vitro.

[0020] The lead 102 may include a balloon 122 mechanically supported by a body 124 of the lead 102 ("lead body 124"). The lead body 124 may extend from the lead proximal end 110 to the lead distal end 112. The balloon 122 may be positioned proximate to (e.g., near) the lead distal end 112. The balloon 122 may define an internal volume that is configured to receive an inflation medium (e.g., air, saline, or another medium), which in turn causes the balloon 122 to inflate. A pump (such as a syringe) in fluid communication with the balloon 122 may deliver the inflation medium to the balloon 122. During the implantation procedure, the clinician may advance the balloon 122 so that the balloon 122 is completely positioned outside of the introducer 106 to prevent contact between the balloon 122 and the introducer 106 when in the inflated configuration. Once balloon 122 is positioned outside of introducer 106 , the clinician may inflate balloon 122 .

[0021] In an example, the lead body 124 defines an inflation lumen that is fluidly coupled to the internal volume and is configured such that a clinician can deliver an inflation medium to the internal volume defined by the balloon 122. The inflation lumen can extend from a distal portion to a proximal portion of the lead body 124. An outer surface of the lead body 124 can define an opening to the inflation lumen. For example, the lead proximal end 110 can define an opening to the inflation lumen such that the inflation lumen extends from the balloon 122 to the opening.

[0022] The lead 102 may include a fixation mechanism 126 to prevent the lead 102 from shifting or moving (e.g., in a proximal direction) once secured to tissue at a target location. The fixation mechanism 126 may be configured to engage tissue of the heart 108. The fixation mechanism 126 may include, for example, one or more elongated forks, such as fixation forks, that are configured to substantially maintain the orientation of the lead 102 relative to the target site. The fixation mechanism 126 may have any shape, including a helical fixation element, such as shown in FIGS. 1 to 3. Figure 2 A fixation mechanism 126 may be attached to the lead distal end 112. The fixation mechanism may be fixed at the lead distal end 112, or may be retractable / advancable relative to the lead distal end 112.

[0023] In accordance with the techniques of the present disclosure, the lead 102 may include one or more visual markers that the clinician can visually reference and potentially feel during the implantation procedure to help the clinician determine when to inflate the balloon 122. For example, the system 100 may include at least one regional visual marker 128 positioned on an outer surface of the lead body 124. In some examples, the regional visual marker 128 may be integrated into the lead body 124. For example, the regional visual marker 128 may be printed, sprayed, written, or otherwise embossed onto the outer surface of the lead body 124. The regional visual marker 128 may not substantially change the overall diameter of the lead 102, although the regional visual marker 128 may optionally have a substantial width, depth, and / or density sufficient to make the regional visual marker 128 visible. In addition, although in Figure 1A , but the regional visual mark 128 can have any shape. Therefore, other shapes of the regional visual mark 128 are contemplated, such as marks in the shape of a circle (e.g., a dot), a straight line (e.g., a dashed line), a cross (e.g., a cross-hatched line), etc. In addition, the regional visual mark 128 can be marked, for example, with words, letters, pictures or symbols, coloring, etc.

[0024] A regional visual marker 128 may be positioned on the lead body 124 in accordance with the techniques of the present disclosure to assist the clinician in determining when to inflate the balloon 122. For example, the regional visual marker 128 may be positioned such that alignment of a distal end 130 ("regional distal end 130") of the regional visual marker 128 with the introducer proximal end 114 indicates alignment of the lead distal end 112 and the introducer distal end 116. Thus, alignment of the regional distal end 130 with the introducer proximal end 114 may indicate when to withdraw the introducer 106 from the patient 104 (e.g., to allow the balloon 122 to inflate without contacting the introducer 106) or otherwise move the introducer 106 relative to the lead 102.

[0025] Additionally, the regional visual marker 128 may be positioned such that alignment of a proximal end 132 of the regional visual marker 128 ("regional proximal end 132") with the introducer proximal end 114 may indicate when the balloon 122 is fully positioned outside of the introducer 106. In some examples, the longitudinal length of the regional visual marker 128 (i.e., the distance from the regional proximal end 132 to the regional distal end 130) may substantially correspond to (e.g., be approximately equal to) the longitudinal length from the proximal end of the balloon 122 to the lead distal end 112. Thus, alignment of the regional proximal end 132 with the introducer proximal end 114 may indicate when the balloon 122 is inflated. It should be understood that the introducer 106 may be retracted more so that the regional proximal end 132 is distal to the introducer proximal end 114. The regional proximal end 132 distal to the introducer proximal end 114 may also indicate when the balloon 122 is inflated. In some examples, alignment of region proximal end 132 with introducer proximal end 114 may indicate when to deflate balloon 122 so that balloon 122 may be retracted by introducer 106 .

[0026] like Figure 1A As shown, the regional visual marker 128 is external. Therefore, the clinician can see the regional visual marker 128 with the naked eye (e.g., without the use of imaging techniques, such as fluoroscopy). In this way, the technology of the present disclosure allows the clinician to implant the lead 102 without the use of imaging techniques that may adversely affect the patient, thereby increasing patient safety while potentially increasing the rate of successful implantation procedures.

[0027] Despite Figure 1A106 , but the lead 102 can support multiple regional visual markers 128. This configuration can be advantageous because the type of introducer 106 required for a medical procedure can depend on the medical procedure. As described above, the lengths of different introducers 106 can vary. Therefore, the lead 102 can support multiple regional visual markers 128, where each regional visual marker 128 is compatible with one type of introducer 106 having a certain length. Each regional visual marker 128 can have a unique label, color, or other visual label to facilitate identification of the appropriate regional visual marker for one type of introducer 106.

[0028] Figure 1B 1 is a conceptual diagram showing a lead 102 and an introducer 106. The introducer 106 can be configured to guide another component of the system 100, such as a guidewire (e.g., a thin, flexible medical wire), along an implantation path within the patient's body. For example, the guidewire can be inserted through lumen 118 and advanced to a target site. The introducer 106 can then be translated along the guidewire.

[0029] The longitudinal length L1 of the introducer 106 can substantially correspond to the longitudinal length of the lead 102 extending from the regional distal end 130 to the distal end 134 of the fixation mechanism 126 ("fixation mechanism distal end 134"). Therefore, when the introducer distal end 116 and the fixation mechanism distal end 134 are aligned, the introducer proximal end 114 and the regional distal end 130 can also be aligned. Therefore, the fixation mechanism 126 can be protected within the introducer 106 until the clinician begins to retract the introducer 106. The longitudinal length L3 extending from the proximal end 136 of the balloon 122 ("balloon proximal end 136") to the fixation mechanism distal end 134 can substantially correspond to the longitudinal length L4 of the regional visual marker 128 (i.e., the distance from the regional proximal end 132 to the regional distal end 130). Thus, when the region proximal end 132 and the introducer proximal end 114 are aligned, the balloon 122 can be positioned completely outside of the introducer 106 such that the balloon 122 can be inflated without contacting the introducer 106 .

[0030] Figure 2 1 is a conceptual diagram of an example implantable medical balloon lead 202 ("lead 202") including a regional visual marker 228 and an example sheath introducer 206 ("introducer 206"). Lead 202 can be substantially similar to lead 102 shown in FIG. 1. Introducer 206 can be substantially similar to introducer 106 shown in FIG. 1. Figure 2As shown, the body 224 of the lead 202 ("lead body 224") mechanically supports the balloon 222 near the distal end 212 of the lead 202 ("lead distal end 212"). For example, the distal portion of the lead 202 can mechanically support the balloon 222. Figure 2 As further shown in FIG. 2 , a securing mechanism 226 may be attached to the lead distal end 212 .

[0031] In addition to the regional visual marker 228, the lead 202 may also include one or more visual markers. For example, the lead 202 may include at least one rotational visual marker 238. The rotational visual marker 238 may be positioned on the outer surface of the lead body 224. In some examples, the rotational visual marker 238 may be a longitudinal visual marker. For example, the rotational visual marker 238 may extend around only a portion of the circumference of the lead body 224. In this way, the clinician can visually determine the angular rotation of the rotational visual marker 238 (e.g., by counting the number of rotations of the rotational visual marker 238). The angular rotation of the rotational visual marker 238 may correspond to the angular rotation of the fixing mechanism 226. For example, one rotation of the rotational visual marker 238 may correspond to one rotation of the fixing mechanism 226 (e.g., because the lead 202 is rigid and bends a negligible amount under torsion). In another example, one rotation of the rotational visual marker 238 may correspond to less than one rotation of the fixing mechanism 226 (e.g., because the lead 202 is not rigid and bends a significant amount under torsion). In any case, a relationship between the angular rotation of the rotating visual marker 238 and the angular rotation of the securing mechanism 226 may be determined.

[0032] The clinician can use the angular rotation of the rotational visual marker 238 to determine the extent to which the fixation mechanism 226 has been rotated. This can be advantageous when the clinician rotates the fixation mechanism 226 (which can be a helical or otherwise spirally shaped) to secure the fixation mechanism 226 to the tissue. For example, the fixation mechanism 226 may need to be rotated three times to properly secure to the tissue. If one rotation of the rotational visual marker 238 corresponds to one rotation of the fixation mechanism 226, the clinician can rotate the lead 202 until the clinician observes that the rotational visual marker 238 completes three rotations (which in turn indicates that the fixation mechanism 226 has likewise been rotated three times).

[0033] In some examples, lead 202 can include at least one radiopaque marker 240. Radiopaque markers 240 can each be formed of a radiopaque material embedded within lead 202. In some examples, radiopaque markers 240 can be a band of radiopaque material extending along the periphery of a portion of lead 202. In some examples, fixation tines can be formed of or coated with a radiopaque material.

[0034] In any case, the radiopaque marker 240 can indicate when to withdraw the introducer 206 from the patient (e.g., to allow the balloon 222 to be inflated without contacting the introducer 206). For example, the radiopaque marker 240 and the introducer 206 can be visible during fluoroscopy so that the clinician can visually determine the position of the radiopaque marker 240 relative to the distal end 216 of the introducer 206 ("introducer distal end 216").

[0035] Figure 3 1 is a conceptual diagram of an example implantable medical balloon lead 302 ("lead 302"). Lead 302 may be substantially similar to lead 102 shown in FIG. 1 and / or Figure 2 The lead wire 202 is shown. Figure 2 As shown, the body 324 of the lead 302 ("lead body 324") may include one or more visual indicia, such as rotational visual indicia 338A to 338N (collectively "rotational visual indicia 338") and depth visual indicia 344A to 344C (collectively "depth visual indicia 344"). In some examples, and as shown in FIG. Figure 3 As shown, the rotating visual marker 338 can indicate a series of measurement levels. For example, the rotating visual marker 338 can represent sub-labels spaced apart in 1 cm increments. In this way, the rotating visual marker 338 can help the clinician measure the movement of the lead 302. For example, the clinician can introduce 3 cm of lead slack by advancing the lead 302 into the introducer 306 by three rotating visual markers 338. For similar reasons, the rotating visual marker 338 can help the management of the lead 302. For example, the rotating visual marker 338 can indicate when the lead 302 is pushed, pulled, rotated, etc., and the clinician can use this information to avoid displacement 302.

[0036] The depth visual marker 344 can be positioned on the outer surface of the lead body 324. The depth visual marker 344 can be a circumferential marker. For example, the depth visual marker 344 can extend completely around the circumference of the lead body 324. In some examples, the rotation visual marker 338 can be positioned proximate to the depth visual marker 344. The depth visual marker 344 can indicate the insertion depth of the lead through the lumen 318 of the introducer 306. The introducer 306 can be substantially similar to the introducer 106 shown in FIG. 1 and / or Figure 2 Introducer 206 is shown.

[0037] During insertion of the lead 302 into the introducer 306, the entire length of the lead 302 moves, causing the visual marker of the lead 302 to also move. The clinician can determine the length of the lead 302 inserted into the introducer 306 by visually or manually referencing the relative movement of the depth visual marker 344 to a reference point. In this way, the depth visual marker 344 can help the clinician determine whether a sufficient amount of the lead 302 has been introduced into the patient's body.

[0038] For example, the depth visual marker 344 can be positioned so that the alignment of the depth visual marker 344A with the proximal end 314 of the introducer 306 ("introducer proximal end 314") indicates the insertion depth of the lead 302 of a first length (e.g., 10 centimeters (cm)), the alignment of the depth visual marker 344B with the guide proximal end 314 indicates the insertion depth of the lead 302 of a second length (e.g., 20 cm), and the alignment of the depth visual marker 344C with the guide proximal end 314 indicates the insertion depth of the lead 302 of a third length (e.g., 30 cm). It should be understood that increments other than 10 cm (e.g., increments of 5 cm, 15 cm, etc.) are also contemplated by the present disclosure. Moreover, it should be understood that the lead 302 can include more or fewer depth visual markers 344.

[0039] Figure 4 is a flow chart of an example technique for delivering a lead of appropriate length into a patient's body. Figure 4 Mainly in Figure 1A and Figure 1B 100, but it should be understood that Figure 4 The method can be applied to other examples of implant tool systems described herein.

[0040] The clinician (or other medical practitioner) can insert the introducer 106 into the patient's body (400). For example, the clinician can insert the introducer 106 through the entry point 120. The clinician can advance the introducer 106 along the implantation path. In some examples, the advancement of the introducer 106 (and / or other components of the system 100) can be guided by ultrasound. By using ultrasound, the clinician can avoid or limit the use of fluoroscopic observation, which can increase the safety of the implantation procedure.

[0041] The clinician can advance the lead 102 into the patient's body (402). For example, the clinician can translate the lead 102 relative to the introducer 106 until the regional distal end 130 and the introducer proximal end 114 are aligned. In some examples, the alignment of the regional distal end 130 and the introducer proximal end 114 can indicate that the lead distal end 112 and the introducer distal end 116 are aligned. In some examples, the alignment of the regional distal end 130 and the introducer proximal end 114 can indicate that the fixation mechanism distal end 134 and the introducer distal end 116 are aligned. In any case, the alignment of the regional distal end 130 and the introducer proximal end 114 can indicate when to retract the introducer 106.

[0042] The clinician may retract the introducer 106 (404). For example, the clinician may retract the guide wire introducer 106 until the regional proximal end 132 and the introducer proximal end 114 are aligned. The alignment of the regional proximal end 132 with the introducer proximal end 114 may indicate that the balloon 122 of the guide wire 102 is fully positioned outside of the introducer 106. Therefore, the alignment of the regional proximal end 132 with the introducer proximal end 114 may indicate that it is safe to inflate the balloon 122.

[0043] In response to aligning the region proximal end 132 with the introducer proximal end 114 (or retracting the introducer 106 so that the region proximal end 132 is distal to the introducer proximal end 114). It should be understood that the introducer 106 can be retracted more so that the region proximal end 132 is distal to the introducer proximal end 114. The region proximal end 132 distal to the introducer proximal end 114 can also indicate when to inflate the balloon 122.

[0044] In response to the region proximal end 132 being aligned with the introducer proximal end 114 or being distal to the introducer proximal end, the clinician can inflate the balloon 122 without any possibility of the balloon 122 contacting the introducer 106 (406). In some examples, when the balloon 122 is inflated, the clinician can electrically test one or more implantation sites. Based on the signals detected from the implantation sites, the clinician can select an implantation site as the target site for implantation. If the lead distal end 112 is not yet at or near the target site, the clinician can advance the lead 102. Before attaching the lead 102 to the target site, the clinician can completely deflate the balloon 122 (408). The clinician can then attach the lead 102 to the target site (410).

[0045] Figure 5 is a flow chart of an example technique for delivering a lead of appropriate length into a patient's body. Figure 5The system 100 of FIG. 1 is discussed primarily in the context of FIG. 1 , but it should be understood that Figure 5 The method can be applied to other examples of implant tool systems as described herein.

[0046] In some cases, a clinician may wish to test balloon 122 after it has been inflated. In such cases, it may be important to deflate balloon 122 when introducer 106 is not proximal to balloon 122. Thus, alignment of region proximal end 132 with or distal to introducer proximal end 114 may indicate when to deflate balloon 122 and retract implantable medical lead 102 through lumen 118.

[0047] Thus, after the clinician inflates balloon 122 (500), the clinician can check whether the regional proximal end 132 is aligned with or distal to the introducer proximal end 114. If the regional proximal end 132 is aligned with or distal to the introducer proximal end 114, the clinician can deflate balloon 122 (502). Once balloon 122 is fully deflated, the clinician can withdraw lead 102 through lumen 118 and from the patient's body (504).

[0048] The following examples are illustrative of the techniques described herein.

[0049] Embodiment 1: An implantation tool system, the implantation tool system comprising: an implantable medical device, the size of which is set to be able to be inserted from the proximal end of the introducer through the lumen of the introducer to the distal end of the introducer, wherein the implantable medical device comprises: a device body, which extends from the proximal end of the implantable medical device to the distal end of the implantable medical device; a balloon, which is mechanically supported by the device body; a fixing mechanism, which is configured to attach the distal end of the implantable medical device to a target site in the patient's body; and a regional visual marker, which A regional visual mark is positioned on the outer surface of the device body, the regional visual mark comprising: a distal end of the regional visual mark, wherein the distal end of the regional visual mark is aligned with the proximal end of the introducer to indicate when the introducer is moved relative to the implantable medical device; and a proximal end of the regional visual mark, wherein the proximal end of the regional visual mark is aligned with the proximal end of the introducer to indicate when the balloon is inflated and the distal end of the implantable medical device is attached to the target site via the fixing mechanism, or when the balloon is deflated so that the balloon can be retracted through the introducer.

[0050] Example 2: An implant tool system according to Example 1, wherein the proximal end of the regional visual mark is aligned with the proximal end of the introducer or is distal to the proximal end of the introducer, indicating when to deflate the balloon and retract the implantable medical device through the lumen.

[0051] Embodiment 3: An implant tool system according to embodiment 1 or 2, wherein the fixing mechanism is a spiral.

[0052] Embodiment 4: An implant tool system according to any one of embodiments 1 to 3, wherein the implantable medical device includes a rotational visual mark positioned on the outer surface of the device body, wherein the angular rotation of the rotational visual mark corresponds to the angular rotation of the fixing mechanism.

[0053] Embodiment 5: An implant tool system according to embodiment 4, wherein the rotational visual mark is a longitudinal visual mark extending around only a portion of the circumference of the device body.

[0054] Embodiment 6: An implant tool system according to any one of Embodiments 1 to 5, wherein the implantable medical device comprises one or more depth visual marks positioned on the outer surface of the device body, and the one or more depth visual marks indicate the insertion depth of the implantable medical device through the lumen.

[0055] Embodiment 7: The implant tool system of embodiment 6, wherein the one or more depth visual marks are circumferential visual marks extending completely around the circumference of the device body.

[0056] Embodiment 8: According to any one of embodiments 1 to 7, the implant tool system, wherein the implantable medical device includes at least one radiopaque marker, and the at least one radiopaque marker indicates when to move the introducer relative to the implantable medical device.

[0057] Embodiment 9: According to any one of embodiments 1 to 8, the implant tool system, wherein the regional visual marker is integrated into the device body.

[0058] Embodiment 10: According to any one of embodiments 1 to 9, the implantable medical device comprises an implantable medical lead configured to deliver therapy to the patient.

[0059] Example 11: A method, the method comprising: inserting an introducer through an entry point on a patient's body, wherein the introducer defines a lumen extending from a proximal end of the introducer to a distal end of the introducer; inserting an implantable medical device through the lumen until a distal end of an area visual marker positioned on an outer surface of a device body of the implantable medical device is aligned with the proximal end of the introducer; moving the introducer relative to the implantable medical device, at least until the proximal end of the area visual marker is aligned with the proximal end of the introducer; and inflating a balloon mechanically supported by the device body, or deflating the balloon, so that the balloon can be retracted through the introducer.

[0060] Example 12: A method according to Example 11, wherein the method further includes deflation of the balloon as the proximal end of the regional visual marker is aligned with the proximal end of the introducer or is distal to the proximal end of the introducer; and retracting the implantable medical device through the lumen.

[0061] Embodiment 13: The method according to Embodiment 11 or 12, wherein the implantable medical device comprises a fixation mechanism, and wherein the fixation mechanism is a helix.

[0062] Example 14: A method according to any one of Examples 11 to 13, wherein the implantable medical device includes a rotational visual mark positioned on the outer surface of the device body, wherein the angular rotation of the rotational visual mark corresponds to the angular rotation of the fixing mechanism, and wherein the method further includes: positioning the distal end of the implantable medical device so that the distal end of the implantable medical device is adjacent to the target site; rotating the implantable medical device; and stopping the rotation of the implantable medical device based on the angular rotation of the rotational visual mark.

[0063] Embodiment 15: A method according to Embodiment 14, wherein the rotational visual mark is a longitudinal visual mark that extends around only a portion of the circumference of the device body.

[0064] Embodiment 16: A method according to any one of Embodiments 11 to 15, wherein the implantable medical device comprises one or more depth visual markings positioned on the outer surface of the device body, the one or more depth visual markings indicating the insertion depth of the implantable medical device through the lumen.

[0065] Embodiment 17: The method of Embodiment 16, wherein the one or more depth vision markers are circumferential vision markers that extend completely around a portion of the device body.

[0066] Embodiment 18: The method of any one of Embodiments 11 to 17, wherein the implantable medical device comprises at least one radiopaque marker indicating when to retract the introducer.

[0067] Embodiment 19: A method according to any one of embodiments 11 to 18, wherein the regional visual marker is integrated into the device body.

[0068] Embodiment 20: The method according to any one of Embodiments 11 to 19, wherein the implantable medical device comprises an implantable medical lead configured to deliver therapy to the patient.

[0069] Various aspects of the disclosure have been described. These and other aspects are within the scope of the following claims.

Claims

1. An implantation tool system, comprising: An implantable medical device, the size of which is set to be insertable from the proximal end of an introducer through the lumen of the introducer to the distal end of the introducer, wherein the implantable medical device comprises: a device body extending from a proximal end of the implantable medical device to a distal end of the implantable medical device; a balloon mechanically supported by the device body; a securing mechanism configured to attach the distal end of the implantable medical device to a target site within a patient's body; and A regional visual mark, the regional visual mark is positioned on the outer surface of the device body, the regional visual mark comprises: a distal end of the regional visual marking, wherein alignment of the distal end of the regional visual marking with the proximal end of the introducer indicates when the introducer is moved relative to the implantable medical device; and a proximal end of the regional visual marker, wherein alignment of the proximal end of the regional visual marker with the proximal end of the introducer indicates when: inflating the balloon and attaching the distal end of the implantable medical device to the target site via the fixation mechanism, or The balloon is deflated so that it can be withdrawn through the introducer.

2. An implant tool system according to claim 1, wherein the proximal end of the regional visual marker is aligned with the proximal end of the introducer or is distal to the proximal end of the introducer, indicating when to deflate the balloon and retract the implantable medical device through the lumen.

3. An implant tool system according to claim 1 or 2, wherein the fixing mechanism is a spiral.

4. An implant tool system according to any one of claims 1 to 3, wherein the implantable medical device includes a rotational visual mark positioned on the outer surface of the device body, wherein the angular rotation of the rotational visual mark corresponds to the angular rotation of the fixing mechanism.

5. An implant tool system according to claim 4, wherein the rotational visual marker is a longitudinal visual marker extending around only a portion of the circumference of the device body.

6. An implant tool system according to any one of claims 1 to 5, wherein the implantable medical device includes one or more depth visual marks positioned on the outer surface of the device body, and the one or more depth visual marks indicate the insertion depth of the implantable medical device through the lumen.

7. An implant tool system according to claim 6, wherein the one or more depth visual markers are circumferential visual markers that extend completely around the circumference of the device body.

8. An implant tool system according to any one of claims 1 to 7, wherein the implantable medical device includes at least one radiopaque marker, and the at least one radiopaque marker indicates when to move the introducer relative to the implantable medical device.

9. An implant tool system according to any one of claims 1 to 8, wherein the regional visual marker is integrated into the device body.

10. The implant tool system of any one of claims 1 to 9, wherein the implantable medical device comprises an implantable medical lead configured to deliver therapy to the patient.

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