Surgical systems and devices for inserting a lead with one or more tines and collapsing the one or more tines

Abstract

Surgical systems and devices for inserting a lead with one or more tines and collapsing the one or more tines are provided. The system may include an introducer defining a pathway to a target surgical site and having a body extending from a first end to a second end. The body also has a bore extending from a first opening at the first end to a second opening at the second end. A surgical tool is configured to collapse one or more tines of a lead from a first diameter to a second diameter such that the lead can fit through the first opening, the second opening, and the bore and travel through the pathway to the target surgical site.

Description

SURGICAL SYSTEMS AND DEVICES FOR INSERTING A LEAD WITH ONE OR MORE TINES AND COLLAPSING THE ONE OR MORE TINESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 542,718, filed October 5, 2023, the entire content of each of which is incorporated herein by reference.BACKGROUND

[0002] The present disclosure is generally directed to a lead with one or more tines, and relates more particularly to collapsing the one or more tines when inserting the lead into a patient.

[0003] Leads with one or more tines are used to fix the leads to a target anatomical area in a patient. The leads may be inserted using an introducer. However, the tine(s) on the lead are angled and extend from the lead and may not fit into an opening of the introducer or may improperly collapse within the introducer. Improperly collapsed tine(s) may result in improper installation of or fixation of the lead to the target anatomical element.BRIEF SUMMARY

[0004] A surgical tool configured to collapse one or more tines of a lead is provided. The surgical tool beneficially enables proper collapsing of the one or more tines of the lead such that the lead can be inserted into a patient via an introducer and to a target surgical site. The one or more tines can then be properly deployed at the target surgical site. The surgical tool may include various components and / or any combination of components and may take on various forms such as, for example, a clip-on surgical tool for collapsing bidirectional tines, a funnel, a funnel in the form of one or more slots, etc. The surgical tool may be a component separate from the introducer or may be integrated with the introducer.

[0005] Example aspects of the present disclosure include:

[0006] A surgical system for inserting a lead according to at least one embodiment of the present disclosure comprises an introducer having a body extending from a first end to a second end, the body having a bore extending from a first opening at the first end to a second opening at the second end, the introducer defining a pathway to a target surgical site; and a surgical tool configured to collapse one or more tines of a lead from a first diameter to a second diameter such that the lead can fit through the first opening, the second opening, and the bore and travel through the pathway to the target surgical site.

[0007] Any of the aspects herein, wherein the surgical tool is integrated with the introducer.

[0008] Any of the aspects herein, wherein the surgical tool has a tool body extending from a first tool end to a second tool end, the tool body having a tool bore extending from the first tool end to the second tool end, the tool bore having a diameter larger at the first tool end than the second tool end, and wherein the one or more tines collapse when moved through the tool bore from the first tool end to the second tool end.

[0009] Any of the aspects herein, wherein the tool bore forms a funnel from the first tool end to the second tool end.

[0010] Any of the aspects herein, wherein a protrusion extends from the tool body, the protrusion configured to align the surgical tool with the introducer.

[0011] Any of the aspects herein, wherein the surgical tool is a component separate from the introducer.

[0012] Any of the aspects herein, wherein the surgical tool has a tool body extending from a first tool end to a second tool end, the tool having at least one slot extending through the tool body from the first tool end to the second tool end, the at least one slot having a width greater at the first tool end than the second tool end, and wherein the one or more tines remain aligned and collapse when moved through the at least one slot from the first tool end to the second tool end.

[0013] Any of the aspects herein, wherein the at least one slot comprises a first slot and a second slot, wherein the first slot is perpendicular to the second slot.

[0014] Any of the aspects herein, wherein the surgical tool includes a first tool body connected to a second tool body via a hinge, wherein the first tool body and the second tool body form a cavity when clipped onto the lead such that the cavity receives the lead with a second set of tines in a noncollapsed position, and wherein a first set of tines is positioned outside of the surgical tool.

[0015] Any of the aspects herein, wherein the first tool body and the second tool body form a slot that is adjacent to the cavity at a first slot end, the slot having a smaller diameter than the cavity such that the first set of tines collapse when moved from through the slot towards the cavity and the second set of tines collapse when moved from the cavity towards the slot.

[0016] Any of the aspects herein, wherein the cavity defines a stop that the second set of tines contact when the first set of tines is moved towards the cavity.

[0017] Any of the aspects herein, wherein the first tool body includes a protrusion and the second tool body includes a receptacle configured to receive the protrusion, wherein the first tool body and the second tool body are connected when the protrusion is received in the receptacle.

[0018] A surgical tool according to at least one embodiment of the present disclosure comprises a first tool body; a second tool body; a hinge connecting the first tool body and the second tool body, wherein the first tool body and the second tool body form a cavity when clipped onto a lead such that the cavity receives the lead with a second set of tines in a non-collapsed position, and wherein a first set of tines is positioned outside of the surgical tool.

[0019] Any of the aspects herein, wherein the first tool body and the second tool body form a slot that is adjacent to the cavity at a first slot end, the slot having a smaller diameter than the cavity such that the first set of tines collapse when moved from through the slot towards the cavity and the second set of tines collapse when moved from the cavity towards the slot.

[0020] Any of the aspects herein, wherein the cavity defines a stop that the second set of tines contact when the first set of tines is moved towards the cavity.

[0021] Any of the aspects herein, wherein the first tool body includes a protrusion and the second tool body includes a receptacle configured to receive the protrusion, wherein the first tool body and the second tool body are connected when the protrusion is received in the receptacle.

[0022] Any of the aspects herein, wherein when the first tool body and the second tool body form a tool bore through which a lead can be inserted through.

[0023] Any of the aspects herein, wherein the first tool body and the second tool body have a flange configured to be received by one or more clips of an introducer, and wherein the surgical tool is secured to the introducer by clipping the flange into the one or more clips.

[0024] A surgical tool according to at least one embodiment of the present disclosure comprises a tool body extending from a first tool end to a second tool end, at least one slot extending through the tool body from the first tool end to the second tool end, the at least one slot having a width greater at the first tool end than the second tool end, wherein the one or more tines remain aligned and collapse when moved through the at least one slot from the first tool end to the second tool end.

[0025] Any of the aspects herein, wherein the at least one slot comprises a first slot and a second slot, wherein the first slot is perpendicular to the second slot.

[0026] Any aspect in combination with any one or more other aspects.

[0027] Any one or more of the features disclosed herein.

[0028] Any one or more of the features as substantially disclosed herein.

[0029] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0030] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments .

[0031] Use of any one or more of the aspects or features as disclosed herein.

[0032] It is to be appreciated that any feature described herein can be claimed in combination with any other feature(s) as described herein, regardless of whether the features come from the same described embodiment.

[0033] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

[0034] The phrases “at least one”, “one or more”, and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and / or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as XI -Xn, Yl-Ym, and Zl-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., XI and X2) as well as a combination of elements selected from two or more classes (e.g., Y1 and Zo).

[0035] The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.

[0036] The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.

[0037] Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0038] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.

[0039] Fig. 1 A is a block diagram of a system according to at least one embodiment of the present disclosure;

[0040] Fig. IB is an isometric view of an introducer and a dilator according to at least one embodiment of the present disclosure;

[0041] Fig. 1C is an isometric exploded view of the introducer and the dilator of Fig. IB according to at least one embodiment of the present disclosure;

[0042] Fig. 2A is a side cross-sectional view of an introducer and a lead with bidirectional tines according to at least one embodiment of the present disclosure;

[0043] Fig. 2B is an isometric view of a surgical tool with bidirectional tines according to at least one embodiment of the present disclosure;

[0044] Fig. 2C is an isometric view of a surgical tool according to at least one embodiment of the present disclosure;

[0045] Fig. 2D is a side cross-sectional view of the surgical tool and the lead with bidirectional tines according to at least one embodiment of the present disclosure;

[0046] Fig. 2E is a side cross-sectional view of the surgical tool and the lead with bidirectional tines according to at least one embodiment of the present disclosure;

[0047] Fig. 2F is a side view of the introducer, the surgical tool, and the lead with bidirectional tines according to at least one embodiment of the present disclosure;

[0048]

[0049] Fig. 3A is an isometric view of a surgical tool according to at least one embodiment of the present disclosure;

[0050] Fig. 3B is a front view of the surgical tool of Fig. 3 A according to at least one embodiment of the present disclosure;

[0051] Fig. 3C is a side cross-sectional view of the surgical tool of Fig. 3 A according to at least one embodiment of the present disclosure;

[0052] Fig. 3D is a side cross-sectional view of the surgical tool of Fig. 3 A and a shaft according to at least one embodiment of the present disclosure;

[0053] Fig. 4A is an isometric view of a surgical tool according to at least one embodiment of the present disclosure;

[0054] Fig. 4B is a side cross-sectional view of the surgical tool of Fig. 3 A according to at least one embodiment of the present disclosure;

[0055] Fig. 5 is a side cross-sectional view of a surgical tool and a shaft according to at least one embodiment of the present disclosure;

[0056] Fig. 6A is an isometric view of a surgical tool according to at least one embodiment of the present disclosure; and

[0057] Fig. 6B is a side cross-sectional view of the surgical tool according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0058] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example or embodiment, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, and / or may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the disclosed techniques according to different embodiments of the present disclosure). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0059] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one or more aspects thereof. Unless explicitly stated otherwise, the use or listing of one ormore examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure.

[0060] The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.

[0061] Leads may be used in stimulation and / or neuromodulation therapies. In some applications, the lead may include one or more tines to fix the lead to a target surgical site or anatomical element. For example, the lead may include bidirectional tines. With bidirectional tines, the tines angled towards an introducer entrance (ID) are not able to be inserted into the introducer. Additionally, only distal tines (tines angled towards the introducer) may be required to prevent distal migration. Thus, it is desirable to properly collapse the one or more tines of the lead before insertion or during insertion of the lead into the introducer.

[0062] A surgical tool according to at least one embodiment of the present disclosure provides for a clip-on tine collapser. The clip-on “tine collapser” collapses the distal tines which are angled towards the introducer entrance. The “tine collapser” then clips into the introducer which allows the user to insert the lead and tines into the introducer plastic sheath. The tines are collapsed in the correct direction which ensure that the tines are deployed in the correct direction coming out of the introducer.

[0063] Another surgical tool according to at least one embodiment of the present disclosure provides a funnel which collapses the lead tines in order to allow lead deployment through the introducer. The surgical tool may be a separate component from the introducer that clips onto the introducer or is threaded onto the introducer. In other instances, the surgical tool may be integrated with the introducer.

[0064] In some instances, with either bidirectional tines or distal tines, the lead tines may invert in the introducer plastic sheath, which causes the tines to be deployed in the incorrect direction. The tine inversion can happen due to the lead axis being misaligned with the funnel axis, which results in uneven friction and an uneven approach angle of the tines with respect to the surgical tool and / or the introducer. Inverted tines may also cause additional drag or interference between the Introducer and tines during deployment.

[0065] Thus, another surgical tool according to at least one embodiment of the present disclosure provides a funnel with a tine alignment / centering feature that ensure the tines collapse in the correct direction. In such embodiments, the tine alignment / centering feature may be, for example, one ormore slots and each slot funneling from one end of the surgical tool to another end of the surgical tool.

[0066] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) properly collapsing one or more tines of a lead during or before insertion of the lead into an introducer, (2) properly collapsing bidirectional tines during or before insertion of the lead into an introducer, and / or (3) providing a lead with properly collapsed tines such that the tines can be deployed correctly at a target surgical site or anatomical element.

[0067] Turning first to Figs. 1A-1C, a block diagram and other aspects of a system 100 according to at least one embodiment of the present disclosure are shown. The system 100 includes a surgical device 136 (also referred to herein as an internal neural stimulator or an implantable neural stimulator) with one or more leads 140 that is implanted into a patient 105. The surgical device 136 may be positioned in, for example, a shoulder or pectoral pocket of the patient. In other embodiments, the surgical device 136 can be implanted anywhere in the patient or may be external to the patient. As discussed below, the lead 140 includes one or more electrodes 144 configured to provide electrical stimulation (e.g., a current) to anatomical tissue. In some embodiments, the surgical device 136 may be used to deliver an obstructive sleep apnea (OSA) therapy. For instance, the lead 140 may be implanted within protrusor muscles 103A-103C of the tongue 101 of the patient 105, such as the genioglossus muscle. The genioglossus muscle includes an oblique compartment 103 A and a horizontal compartment 103B, and the lead 140 may be positioned such that the electrodes 144 can stimulate one or both of the oblique compartment 103 A and the horizontal compartment 103B. It will be appreciated that the lead 140 can be used in any other application such as, for example, sacral neuromodulation, spinal neuromodulation, and / or brain neuromodulation.

[0068] In embodiments where the therapy delivered is OSA therapy, the OSA therapy delivered by the surgical device 136 (e.g., through stimulation of anatomical tissue using the electrodes 144) may activate the protrusor muscles 103A-103C to move the tongue 101 forward to promote a reduction of obstruction or narrowing of the upper airway 107 during sleep. The activation of the protrusor muscles 103A-103C may be caused by stimulating the protrusor muscles 103A-103C with an electric current delivered by the electrodes 144.

[0069] The lead 140 may include one or more tines 222 (shown in Fig. 2 A) to anchor the lead 140 to a target anatomical element such as the protrusor muscles 103A-103C. The lead 140 may be implanted using various methods. In some embodiments, a percutaneous procedure may be used to introduce the leads 140 to the patient 105. For example, an introducer 102 (shown in Figs. IB and 1C) may be used to locate a target location and to deliver or insert the lead 140 into the targetlocation. In another example, a surgeon may insert a needle through the lower part of the jaw and tongue 101 of the patient 105 starting from the back of the tongue 101. Once the needle is in place, the surgeon may insert a guidewire through the needle and anchor the guidewire to the tongue 101. Then, the surgeon may place the introducer 102 over the guidewire and, once the introducer 102 is in place, remove the guidewire. The surgeon may then put the lead 140 through the introducer 102 such that the electrodes 144 are positioned within the protrusor muscles 103A-103C. In some embodiments, the surgeon may repeat the above steps for each lead introduced to the patient 105.

[0070] The surgical device 136 (also referred to as an Internal Neural Stimulator) may include leads 140, electrodes 144, and one or more sensors. The surgical device 136 may be an instrument or implantable device capable of providing electric signals to the electrodes 144 disposed on the distal ends of and / or along the leads 140 to cause the electrodes 144 to stimulate proximate patient tissue, one or more anatomical elements (e.g., the spinal cord, one or more nerves, etc.), combinations thereof, and the like. For example, the surgical device 136 may receive instructions from the computing device 102 to generate an electrical pulse capable of providing a stimulation to a nerve of the patient. While nerves and patient tissue are discussed herein, it is to be understood that the electrode may be implanted anywhere within the patient or be disposed on any exterior surface of the patient to stimulate any anatomical tissue or element.

[0071] In some embodiments, the surgical device 136 may include a single electrode 144, while in other embodiments, two or more electrodes 144 may be used. In one embodiment, the electrodes 144 may be disposed proximate muscles in the throat of a patient that control the position of the tongue. Additionally, while not shown, the surgical device 136 may include one or more processors (e.g., one or more DSPs, general purpose microprocessors, graphics processing units, ASICs, FPGAs, or other equivalent integrated or discrete logic circuitry) that are programmed to carry out one or more aspects of the present disclosure. In some examples, the one or more processors may include a memory or may be otherwise configured to perform the aspects of the present disclosure. For example, the one or more processors may provide instructions to the surgical device 136 to perform an electrical stimulation of the nerve or tissue by passing a first current through the electrodes 144.

[0072] As previously mentioned, the lead(s) 140 can be inserted into the patient 105 via an introducer 102 (shown in Figs. 1B-1C and 2A). More specifically, the introducer 102 may be coupled to or integrated with a sheath or a body 108 extending from a first end 110 to a second end 112. The body 108 may have a bore 118 extending from a first opening 114 at the first end 110 to a second opening 116 at the second end 112. The introducer 102 may also include a handle 120 and in the illustrated embodiment, the introducer 102 includes a pair of handles 120.

[0073] The introducer 102 may define a pathway (via the bore 118) to a target surgical site or anatomical element for the lead 140. During insertion, the lead 140 is inserted into the introducer 102 and through the bore 118 to the target surgical site or anatomical element. The body 108 may extend through a protective sleeve 104 in some instances. It will be appreciated that in some embodiments, a dilator 106 may be inserted with the introducer 102 so as to stretch or open a portion of the target anatomical element or surgical site. The dilator 106 can then be removed and the lead 140 inserted. In other embodiments, the introducer 102 may be inserted first, then the dilator 106 may be inserted into the introducer 102 and through the body 108 to dilate the target anatomical element or surgical site. The dilator 106 can then be removed and the lead 140 inserted.

[0074] It is to be understood that, while the introducer 102, the lead(s) 140, and the electrodes 144 are discussed with respect to the system 100, such discussion is in no way limiting, and the introducer 102, the lead(s) 140, and the electrodes 144 may be used in any other system and method not discussed herein.

[0075] The lead 140 as discussed above may include the one or more tines 222 (shown in Figs. 2A, 2D, and 2E). Proper collapsing of the one or more tines 222 as the lead 140 is inserted into and pushed through the introducer 102 is important for proper deployment of the one or more tines 222 at the target surgical site or anatomical element. As will be discussed in detail below, a surgical tool such as surgical tool 200, 300, 400, 500, and / or 600 may be used with the introducer 102 or integrated with the introducer 102 to facilitate proper collapsing of the one or more tines 222 as the lead 140 is inserted into the introducer 102. More specifically, the surgical tool 200, 300, 400, 500, and / or 600 is configured to collapse the one or more tines 222 of the lead 140 from a first diameter to a second diameter such that the lead 140 can fit through the first opening 114, the second opening 116, and the bore 118 and travel through the pathway to the target surgical site.

[0076] Turning to Fig. 2A, a lead 240 with the one or more tines 222 and an introducer 102 are shown. The lead 240 may be the same as or similar to the lead 140 described above. As shown, the one or more tines 222 may include a first set of tines 222A facing a first direction and a second set of tines 222B facing a second direction - also known as bidirectional tines. In such embodiments, some or all of the one or more tines 222 may improperly collapse when passed through the introducer 102. For example, the first set of tines 222 may collapse towards the second set of tines 222 or invert when the first set of tines 222 are pushed through the introducer 102. To mitigate such effect, the surgical tool 200 may be used with the introducer 102 to properly collapse the first set of tines 222A and the second set of tines 222A.

[0077] Turning to Figs. 2B-2E, an isometric view of the surgical tool 200, another isometric view of the surgical tool 200, a side cross-sectional view of the surgical tool 200 and the lead 240, and another side cross-sectional view of the surgical tool 200 and the lead 240 are respectively shown. The surgical tool 200 includes a first tool body 202 connected to a second tool body 204 via a hinge 210. The first tool body 202 includes a protrusion 206 and the second tool body 204 includes a receptacle 208. The first tool body 202 and the second tool body 204 are closed by pivoting the first tool body 202 and / or the second tool body 204 on the hinge 210 towards each other (as shown in Fig. 2C and represented by arrows 242) until the protrusion 206 is received in the receptacle 208, thereby connecting the first tool body 202 and the second tool body 204. It will be appreciated that in other embodiments, the first tool body 202 and the second tool body 204 can be connected or coupled in any way such as, for example, using adhesion, using fasteners to couple the first tool body 202 and the second tool body 204, or the like. As also shown in Figs. 2B-2C, the surgical tool 200 also includes a tool bore 214 for insertion of the lead 240 through the surgical tool 200.

[0078] Turning to Figs. 2D and 2E, the first tool body 202 and the second tool body 204 form a cavity 212 when clipped onto the lead 240 such that the cavity 212 receives one of the first set of tines 222A or the second set of tines 222B in a non-collapsed position (as shown, the second set of tines 222B) and the other of the first set of tines 222A or the second set of tines 222B is positioned adjacent to the and outside of the surgical tool 200 in a non-collapsed position (as shown, the first set of tines 222A). The first tool body 202A and the second tool body 204B also form a slot 216 that is adjacent to the cavity 212 at a first slot end 218. The slot 216 has a smaller diameter than the cavity 212 such that the first set of tines 222 A collapse when moved through the slot 216 towards the cavity 212 and the second set of tines 222B collapse when moved from the cavity 212 towards the slot 216. To collapse the one or more tines 222, the lead 240 is moved in the direction of arrow 230 to collapse the first set of tines 222A. During such movement, the second set of tines 222B contacts a stop surface 232 of the cavity 212 so as to prevent unnecessary pushing of the lead 240 into the surgical tool 200 after the first set of tines 222A are collapsed. The lead 240 can also be moved in the direction of arrow 231, shown in Fig. 2E, to collapse the second set of tines 222B.

[0079] The surgical tool 200 can be clipped on or otherwise attached to the lead at any time such as, for example, in an operating room prior to or during a surgical operation, in manufacturing or packaging prior to shipping, or any other time.

[0080] The surgical tool 200 can be connected to the introducer 102 as shown in Fig. 2F. The surgical tool 200 can be clipped onto the introducer 102 via a flange 244 (labeled in Fig. 2E) clipped into one or more clips 238. In other embodiments, the surgical tool 200 can be attached to theintroducer 102 in any way such as, for example, using adhesion, a press fit, or the like. It will be appreciated that the lead 240 can be inserted into the introducer 102 after the first set of tines 222A is collapsed and / or after the second set of tines 222B is collapsed. In other words, in some instances the lead 240 can be inserted into the introducer 102 after the first set of tines 222A is collapsed (and the second set of tines 222B is in a non-collapsed position in the cavity 212). In other instances, the lead 240 can be inserted into the introducer 102 after the first set of tines 222A and the second set of tines 222B are collapsed. Once both the first set of tines 222A and the second set of tines 222B are collapsed, then the lead 240 can be pushed through the body 108 of the introducer 102 to the target anatomical or surgical site.

[0081] Turning to Figs. 3A-3D, a surgical tool 300 according to at least one embodiment of the present disclosure is shown. Figs. 3 A-3C illustrate an isometric view, a front view, and a side cross- sectional view taken along the line A-A shown in Fig. 3B of the surgical tool 300, respectively. In the illustrated embodiment, the surgical tool 300 is integrated with the introducer 102. The surgical tool 300 as shown has a tool body 302 extending from a first tool end 304 to a second tool end 306. The surgical tool 300 also includes a pair of handles 310 (similar to or the same as the handles of an introducer), though in some embodiments the surgical tool 300 may not include the pair of handles 310. The surgical tool 300 also has at least one slot 312 extending through the tool body 302 from the first tool end 304 to the second tool end 306. A width of the at least one slot 312 continuously decreases from the first tool end 304 to the second tool end 306 so as to funnel from the first tool end 304 to the second tool end 306. In other words, the at least one slot 312 has a first width 318A greater at the first tool end 304 than a second width 318B at the second tool end 306 (as shown in Fig. 3C). As such, the one or more tines 222 collapse when moved through the at least one slot 312 from the first tool end 304 to the second tool end 306 in the direction of arrow 316. Further, the one or more tines 222 remain aligned and are prevented from inverting when passing through the at least one slot 312.

[0082] As shown in the illustrated embodiment, the at least one slot 312 includes a first slot 312A and a second slot 312B and the first slot 312A is perpendicular to the second slot 312B. It will be appreciated that in other embodiments, the at least one slot 312 includes one slot, two slots, or more than two slots. Further, the slot(s) 312 may be configured in any configuration such as, for example, two or more slots positioned at any angle relative to each other. The at least one slot 312 may be orientated to match a corresponding one or more tines 222. For example, if a first pair of tines are positioned at a non-perpendicular angle to a second pair of tines, the at least one slot 312 may include a first slot matching the orientation of the first pair of tines and a second slot may match theorientation of the second pair of tines. Similarly, if the lead 140, 240 (or any lead) includes three pairs of tines, the at least one slot 312 may include three slots.

[0083] As previously described, the surgical tool 300 can be connected to the body 108 such that the lead 140, 240 is inserted into the surgical tool 300 and directly into the body 108 as shown in Fig. 3D. When the lead 140, 240 is inserted into the surgical tool 300, the at least one slot 312 collapses the one or more tines 222.

[0084] Turning to Figs. 4A-4B, an isometric view and a side cross-sectional view taken along line B-B shown in Fig. 4A of a surgical tool 400 according to at least one embodiment of the present disclosure is shown. The surgical tool 400 is generally similar to the surgical tool 300 except that the surgical tool 400 is a component separate from the introducer 102. The surgical tool 400 can be clipped onto, threaded onto, or otherwise attached to the introducer 102.

[0085] The surgical tool 400 as shown has a tool body 402 extending from a first tool end 404 to a second tool end 406. As shown, the surgical tool body 402 may be generally cylindrical, though the tool body 402 can be any shape or size. The surgical tool 400 also has at least one slot 412 extending through the tool body 402 from the first tool end 404 to the second tool end 406. A width of the at least one slot 412 continuously decreases from the first tool end 404 to the second tool end 406 so as to funnel from the first tool end 404 to the second tool end 406. In other words, the at least one slot 412 has a first width 418A greater at the first tool end 404 than a second width 418B the second tool end 406 (as shown in Fig. 4B). As such, the one or more tines 222 collapse when moved through the at least one slot 412 from the first tool end 404 to the second tool end 406 in the direction of arrow 416. Further, the one or more tines 222 remain aligned when passing through the at least one slot 412.

[0086] As shown in the illustrated embodiment, the at least one slot 412 includes a first slot 412A and a second slot 412B and the first slot 412A is perpendicular to the second slot 412B. It will be appreciated that in other embodiments, the at least one slot 412 includes one slot, two slots, or more than two slots. Further, the slot(s) may be configured in any configuration such as, for example, two or more slots positioned at any angle relative to each other. The at least one slot 412 may be orientated to match a corresponding one or more tines 222. For example, if a first pair of tines are positioned at a non-perpendicular angle to a second pair of tines, the at least one slot 412 may include a first slot matching the orientation of the first pair of tines and a second slot may match the orientation of the second pair of tines. Similarly, if the lead (whether the lead 140, 240, or any other lead) includes three pairs of tines, the at least one slot 412 may include three slots.

[0087] The surgical tool 400 also includes a tool protrusion 430 that is receivable by the introducer 102. The tool protrusion 430 aids in aligning the surgical tool 400 with the introducer 102. The surgical tool 400 may also include a flange 415, as shown, that abuts the introducer 102 so as to provide a stable connection between the surgical tool 400 and the introducer 102. The flange 415 can also be received by clips of the introducer 102 so as to clip the surgical tool 400 to the introducer 102.

[0088] Turning to Fig. 5, a cross-sectional side view of a surgical tool 500 according to at least one embodiment of the present disclosure is shown. The surgical tool 500 includes a tool body 502 extending from a first tool end 504 to a second tool end 506. The tool body 502 has a tool bore 510 extending from the first tool end 504 to the second tool end 506. As shown, the tool bore 510 has a first diameter 518A at the first tool end 504 that is larger than a second diameter 518B at the second tool end 506 and a diameter of the tool bore 510 continuously decreases from the first diameter 518A to the second diameter 518B. In other words, the tool bore 510 defines a funnel. During use, the one or more tines 222 collapse when moved through the tool bore 510 from the first tool end 504 to the second tool end 506 in the direction of arrow 516. In the illustrated embodiment, the surgical tool 500 is integrated with the introducer 102 and includes a pair of handles 520 similar to or the same as the handles of the introducer 102. In other embodiments, the surgical tool 500 may not include the pair of handles. As shown, during use, the surgical tool 500 is connected to - or is already connected to and / or integrated with - the body 108.

[0089] Turning to Figs. 6A-6B, an isometric view and a side cross-sectional view of a surgical tool 600 according to at least one embodiment of the present disclosure is shown, respectively. The surgical tool 600 is generally similar to the surgical tool 500 except that the surgical tool 600 is a component separate from the introducer 102. The surgical tool 600 can be clipped onto, threaded onto, or otherwise attached to the introducer 102.

[0090] The surgical tool 600 includes a tool body 602 extending from a first tool end 604 to a second tool end 606. As shown, the surgical tool body 602 may be generally cylindrical, though the tool body 602 can be any shape or size. The tool body 602 has a tool bore 610 extending from the first tool end 604 to the second tool end 606. As shown, the tool bore 610 has a first diameter 618 A at the first tool end 604 that is larger than a second diameter 618B at the second tool end 606 and the tool bore 620 continuously decreases from the first diameter 618A to the second diameter 618B. In other words, the tool bore 610 defines a funnel. During use, the one or more tines 222 collapse when moved through the tool bore 610 from the first tool end 604 to the second tool end 606 in the direction of arrow 616. In the illustrated embodiment, the surgical tool 600 also includes a toolprotrusion 630 that is receivable by the introducer 102. The tool protrusion 630 aids in aligning the surgical tool 600 with the introducer 102. The surgical tool 600 may also include a flange 615, as shown, that abuts the introducer 102 so as to provide a stable connection between the surgical tool 600 and the introducer 102. The flange 615 can also be received by clips of the introducer 102 so as to clip the surgical tool 600 to the introducer 102.

[0091] It will be appreciated that a surgical tool can include any combination of components. For example, a surgical tool can be a separate component from an introducer and include one or more handles. In another example, a surgical tool can include a tuohy borst to collapse one or more tines. For example, a surgical tool can include a cavity and a touhy borst inside of the cavity, which can be used to collapse the one or more tines within the cavity. Further, the surgical tool in any form can be integrated with or otherwise adapted to an introducer.

[0092] The surgical tool such as surgical tool(s) 200, 300, 400, 500, 600 or any combination of components of the surgical tool beneficially enable proper collapsing of one or more tines of a lead (whether the lead 140, 240, or any other lead) such that the lead can be inserted into a patient to a target surgical site and the one or more tines can be properly deployed at the target surgical site.

[0093] The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and / or configurations of the disclosure may be combined in alternate aspects, embodiments, and / or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and / or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0094] Moreover, though the foregoing has included description of one or more aspects, embodiments, and / or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and / or configurations to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures,functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0095] Example Statements are provided below:

[0096] Statement 1. A surgical system (100) for inserting a lead (140) comprising: an introducer (102) having a body (108) extending from a first end (110) to a second end (112), the body having a bore (118) extending from a first opening (114) at the first end to a second opening (116) at the second end, the introducer defining a pathway to a target surgical site; and a surgical tool (200, 300, 400, 500, 600) configured to collapse one or more tines (222) of a lead (140) from a first diameter to a second diameter such that the lead can fit through the first opening, the second opening, and the bore and travel through the pathway to the target surgical site.

[0097] Statement 2. The surgical system of Statement 1 , wherein the surgical tool is integrated with the introducer.

[0098] Statement 3. The surgical system of Statements 1 or 2, wherein the surgical tool has a tool body (202, 302, 402, 502, 602) extending from a first tool end (204, 304, 404, 504 604) to a second tool end (206, 306, 406, 506, 606), the tool body having a tool bore (214, 510) extending from the first tool end to the second tool end, the tool bore having a diameter larger at the first tool end than the second tool end, and wherein the one or more tines collapse when moved through the tool bore from the first tool end to the second tool end.

[0099] Statement 4. The surgical system of any of Statements 1-3, wherein the tool bore forms a funnel from the first tool end to the second tool end.

[0100] Statement 5. The surgical system of Statement of any of Statements 1-3, wherein a protrusion (430, 630) extends from the tool body, the protrusion configured to align the surgical tool with the introducer.

[0101] Statement 6. The surgical system of any of Statements 1-5 wherein the surgical tool is a component separate from the introducer.

[0102] Statement 7. The surgical system of any of Statements 1-6, wherein the surgical tool has a tool body (202, 302, 402, 502, 602) extending from a first tool end (204, 304, 404, 504 604) to a second tool end(206 306, 406, 506, 606), the tool having at least one slot (312, 412) extending through the tool body from the first tool end to the second tool end, the at least one slot having a width greater at the first tool end than the second tool end, and wherein the one or more tines remain aligned and collapse when moved through the at least one slot from the first tool end to the second tool end.

[0103] Statement 8. The surgical system of any of Statements 1-7, wherein the at least one slot comprises a first slot (312A) and a second slot (312B), wherein the first slot is perpendicular to the second slot.

[0104] Statement 9. The surgical system of any of Statements 1-8, wherein the surgical tool includes a first tool body (202) connected to a second tool body (204) via a hinge (210), wherein the first tool body and the second tool body form a cavity (212) when clipped onto the lead such that the cavity receives the lead with a second set of tines in a non-collapsed position, and wherein a first set of tines is positioned outside of the surgical tool.

[0105] Statement 10. The surgical system of any of Statements 1-9, wherein the first tool body and the second tool body form a slot (216) that is adjacent to the cavity at a first slot end (218), the slot having a smaller diameter than the cavity such that the first set of tines collapse when moved from through the slot towards the cavity and the second set of tines collapse when moved from the cavity towards the slot.

[0106] Statement 11. The surgical system of any of Statements 1-10, wherein the cavity defines a stop (232) that the second set of tines contact when the first set of tines is moved towards the cavity.

[0107] Statement 12. The surgical system of any of Statements 1-11, wherein the first tool body includes a protrusion (206) and the second tool body includes a receptacle (208) configured to receive the protrusion, wherein the first tool body and the second tool body are connected when the protrusion is received in the receptacle.

[0108] Statement 13. A surgical tool (200) comprising: a first tool body (202); a second tool body (204); a hinge (210) connecting the first tool body and the second tool body, wherein the first tool body and the second tool body form a cavity (212) when clipped onto a lead (140) such that the cavity receives the lead with a second set of tines in a non-collapsed position, and wherein a first set of tines is positioned outside of the surgical tool.

[0109] Statement 14. The surgical tool of Statement 13, wherein the first tool body and the second tool body form a slot (216) that is adjacent to the cavity at a first slot end (218), the slot having a smaller diameter than the cavity such that the first set of tines collapse when moved from through the slot towards the cavity and the second set of tines collapse when moved from the cavity towards the slot.

[0110] Statement 15. The surgical tool of Statements 13 or 14, wherein the cavity defines a stop (232) that the second set of tines contact when the first set of tines is moved towards the cavity.

[0111] Statement 16. The surgical tool of any of Statements 13-15, wherein the first tool body includes a protrusion (206) and the second tool body includes a receptacle (208) configured toreceive the protrusion, wherein the first tool body and the second tool body are connected when the protrusion is received in the receptacle.

[0112] Statement 17. The surgical tool of any of Statements 13-16, wherein when the first tool body and the second tool body form a tool bore (214) through which a lead (140) can be inserted through.

[0113] Statement 18. The surgical tool of any of Statements 13-17, wherein the first tool body and the second tool body have a flange (244) configured to be received by one or more clips of an introducer (102), and wherein the surgical tool is secured to the introducer by clipping the flange into the one or more clips.

[0114] Statement 19. A surgical tool (300, 400, 500, 600) comprising: a tool body (302, 402, 502, 602) extending from a first tool end (304, 404, 504 604) to a second tool end (306, 406, 506, 606), at least one slot (312, 412) extending through the tool body from the first tool end to the second tool end, the at least one slot having a width greater at the first tool end than the second tool end, wherein the one or more tines remain aligned and collapse when moved through the at least one slot from the first tool end to the second tool end.

[0115] Statement 20. The surgical tool of Statement 19, wherein the at least one slot comprises a first slot (312A) and a second slot (312B), wherein the first slot is perpendicular to the second slot.

Claims

CLAIMSWhat is claimed is:

1. A surgical system (100) for inserting a lead (140) comprising: an introducer (102) having a body (108) extending from a first end (110) to a second end (112), the body having a bore (118) extending from a first opening (114) at the first end to a second opening (116) at the second end, the introducer defining a pathway to a target surgical site; and a surgical tool (200, 300, 400, 500, 600) configured to collapse one or more tines (222) of a lead (140) from a first diameter to a second diameter such that the lead can fit through the first opening, the second opening, and the bore and travel through the pathway to the target surgical site.

2. The surgical system of claim 1 , wherein the surgical tool is integrated with the introducer.

3. The surgical system of claims 1 or 2, wherein the surgical tool has a tool body (202, 302, 402, 502, 602) extending from a first tool end (204, 304, 404, 504 604) to a second tool end (206, 306, 406, 506, 606), the tool body having a tool bore (214, 510) extending from the first tool end to the second tool end, the tool bore having a diameter larger at the first tool end than the second tool end, and wherein the one or more tines collapse when moved through the tool bore from the first tool end to the second tool end.

4. The surgical system of any of claims 1-3, wherein the tool bore forms a funnel from the first tool end to the second tool end.

5. The surgical system of claim of any of claims 1-3, wherein a protrusion (430, 630) extends from the tool body, the protrusion configured to align the surgical tool with the introducer.

6. The surgical system of any of claims 1-5 wherein the surgical tool is a component separate from the introducer.

7. The surgical system of any of claims 1-6, wherein the surgical tool has a tool body (202, 302, 402, 502, 602) extending from a first tool end (204, 304, 404, 504 604) to a second tool end(206 306, 406, 506, 606), the tool having at least one slot (312, 412) extending through the tool body from the first tool end to the second tool end, the at least one slot having a width greater at the first tool endthan the second tool end, and wherein the one or more tines remain aligned and collapse when moved through the at least one slot from the first tool end to the second tool end.

8. The surgical system of any of claims 1-7, wherein the at least one slot comprises a first slot (312A) and a second slot (312B), wherein the first slot is perpendicular to the second slot.

9. The surgical system of any of claims 1-8, wherein the surgical tool includes a first tool body (202) connected to a second tool body (204) via a hinge (210), wherein the first tool body and the second tool body form a cavity (212) when clipped onto the lead such that the cavity receives the lead with a second set of tines in a non-collapsed position, and wherein a first set of tines is positioned outside of the surgical tool.

10. The surgical system of any of claims 1-9, wherein the first tool body and the second tool body form a slot (216) that is adjacent to the cavity at a first slot end (218), the slot having a smaller diameter than the cavity such that the first set of tines collapse when moved from through the slot towards the cavity and the second set of tines collapse when moved from the cavity towards the slot.

11. The surgical system of any of claims 1-10, wherein the cavity defines a stop (232) that the second set of tines contact when the first set of tines is moved towards the cavity.

12. The surgical system of any of claims 1-11, wherein the first tool body includes a protrusion (206) and the second tool body includes a receptacle (208) configured to receive the protrusion, wherein the first tool body and the second tool body are connected when the protrusion is received in the receptacle.

13. A surgical tool (200) comprising: a first tool body (202); a second tool body (204); a hinge (210) connecting the first tool body and the second tool body, wherein the first tool body and the second tool body form a cavity (212) when clipped onto a lead (140) such that the cavity receives the lead with a second set of tines in a non-collapsed position, and wherein a first set of tines is positioned outside of the surgical tool.

14. The surgical tool of claim 13, wherein the first tool body and the second tool body form a slot (216) that is adjacent to the cavity at a first slot end (218), the slot having a smaller diameter than the cavity such that the first set of tines collapse when moved from through the slot towards the cavity and the second set of tines collapse when moved from the cavity towards the slot.

15. The surgical tool of claims 13 or 14, wherein the cavity defines a stop (232) that the second set of tines contact when the first set of tines is moved towards the cavity.

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