Wire lead fixing device

Abstract

The fixation device is configured to receive wire leads during surgical treatment and includes a fixation device and a frame. The fixation device defines a longitudinal axis and is configured to be inserted into the patient's access site. The fixation device includes a first body portion and a second body portion pivotably coupled to the first body portion, and the fixation device is reconfigurable between an open configuration and a closed configuration. The frame is coupled to the fixation device and is configured to facilitate the reconfiguration of the fixation device between the open and closed configurations.

Description

Technical Field

[0001] (Related Application) This application claims the benefit and priority of U.S. Provisional Application No. 63 / 453,778, filed Mar. 22, 2023, the entire disclosure of which is incorporated herein by reference.

[0002] (Technical Field) This application relates to an apparatus for securing a wire lead within a patient, and more particularly to a wire lead fixation apparatus configured to be inserted into an access site within the patient's tissue (e.g., a burr hole in the patient's skull).

Background Art

[0003] Some surgical (e.g., neurological) treatments require placement of a wire lead at a target site within the patient's brain, which typically includes a series of fixtures configured to engage the patient's tissue and thereby secure the wire lead. These wire leads are used to transmit therapeutic electrical stimulation (electrical impulses to the target brain site) or to record brain activity for diagnosis and monitoring of various neurological conditions.

[0004] Ensuring proper fixation and placement of these wire leads is crucial for their effective and safe function in clinical applications. Known wire leads may become detached due to carelessness or other unintended movement over time. Such improper fixation of wire leads within the skull can cause inconvenience and troublesome problems. Improper fixation can lead to suboptimal positioning of the electrodes, potentially impairing the accuracy and effectiveness of treatment, for example, insufficient stimulation of the target brain region and reduced therapeutic utility. Improper fixation of wire leads within the skull increases the risk of tissue irritation or inflammation at the implantation site, can cause undesirable movement within brain tissue, and can lead to undesirable side effects. Furthermore, movement of the wire lead can create undesirable gaps between the wire lead and the skull, potentially increasing the risk of infection. In addition, if such movement or displacement places sufficient mechanical stress on the wire lead, it can lead to wire breakage or severance, thereby interrupting the transmission of electrical impulses or the recording of brain activity. Thus, such displacement can impair the reliability and effectiveness of the wire lead. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] Therefore, there is a need to improve the fixation of wire leads during surgical treatment, ensure proper function of wire leads over time, and prevent troublesome problems that may occur when movement is not restricted. [Means for solving the problem]

[0006] The present invention addresses the problems and shortcomings of the prior art by providing a device that improves the fixation of wire leads during surgical treatment. In short, the device comprises a first component configured to enclose a wire lead and a second component that facilitates the movement of the first component, thereby facilitating the fixation of the device to the patient's skull. The device of the present invention restricts, and in some cases completely restricts, the movement of the wire lead, thereby avoiding the risks, potential complications, and reduced clinical effectiveness associated with undesirable wire lead movement.

[0007] In one aspect of the present invention, an immobilization device is provided, comprising an immobilizer and a frame, configured to receive one (or, in some embodiments, more) wire leads during surgical treatment. The immobilizer has a longitudinal axis and is configured to be inserted into an access site in patient tissue. The immobilizer comprises a first body portion and a second body portion movably (e.g., pivotably) coupled to the first body portion, and the immobilization device is reconfigurable between an open configuration and a closed configuration. A frame is coupled to the immobilizer and configured to facilitate the reconfiguration of the immobilization device between an open configuration and a closed configuration.

[0008] In some embodiments, the first and second body portions can be joined by hinge portions extending generally parallel to the longitudinal axis. In some embodiments, the frame may include a first frame portion joined to the first body portion and a second frame portion joined to the second body portion.

[0009] In some embodiments, the first frame portion can be pivotable relative to the first body portion, and the second frame portion can be pivotable relative to the second body portion.

[0010] In some embodiments, the frame may include one or more latches configured to lock the restraint device in a closed configuration. The latches may include recesses configured to receive one or more wire leads in order to guide one or more wire leads away from the patient.

[0011] In some embodiments, the fastening device may further include a cap configured to engage with a fastener and further secure the fastening device within an access portion. The cap may be made of an elastic material such that a radially outward biasing force is generated when the cap is coupled to the fastener. This can help to further secure the fastener. In some embodiments, the cap may include a first leg configured to be inserted into a first body portion and a second leg configured to be inserted into a second body portion, such that when the cap is coupled to the fastener, the first leg extends into the first body portion and the second leg extends into the second body portion. In some embodiments, the first and second legs may extend non-parallel to the longitudinal axis.

[0012] In another aspect of the present invention, a fixation device is provided, comprising a fixation fixture and a frame, configured to receive a wire lead during surgical treatment. The fixation fixture defines a longitudinal axis and is configured to be inserted into a trepanation hole in the patient's skull. The fixation device comprises first and second body portions, each of which preferably includes a generally (substantially) C-shaped configuration defining an inner wall. The first and second body portions are configured to move relative to each other, so that the fixation device can be reconfigured between an open configuration in which the inner walls of the first and second body portions are separated and a closed configuration in which the inner walls of the first and second body portions are arranged adjacently to define a passage configured for receiving a wire lead. A frame is coupled to the fixation fixture and is configured to facilitate the reconfiguration of the fixation device between the open and closed configurations.

[0013] In some embodiments, the fastener may include a recess that communicates with a passage and is configured to receive a wire lead and prevent excessive force from being applied to the wire lead. In some embodiments, the recess may be located at the end of the fastener.

[0014] In some embodiments, the frame can be pivotable relative to a fixture around a pivot axis that extends generally perpendicular to the longitudinal axis.

[0015] In some embodiments, the frame may include one or more latches configured to lock the fastener in a closed configuration, and the one or more latches may extend laterally across the fastener in a relationship generally perpendicular to the longitudinal axis.

[0016] Another aspect of the present invention provides a method for performing a surgical procedure, the method comprising: positioning a wire lead between a first body portion and a second body portion of a fixation device; reconfiguring the fixation device from an open configuration to a closed configuration, thereby holding the wire lead within the fixation device; locking the fixation device in the closed configuration; and inserting the fixation device into an access site.

[0017] In some embodiments, the step of reconfiguring the stationary device from an open configuration to a closed configuration may include pivoting the first and second body portions around a hinge portion.

[0018] In some embodiments, the method may further include the step of coupling a cap to the fixing device in order to further secure the fixing device within the access portion. In some embodiments, the step of coupling a cap to the fixing device may include coupling the cap to the fixing device such that a wire lead extends through the cap. In some embodiments, the step of coupling a cap to the fixing device may include inserting the legs of the cap into the openings of the first and second body portions, thereby biasing the first and second body portions radially outward.

[0019] To enable those skilled in the art to more readily understand the methods of manufacturing and using the wire lead fixing devices and various components thereof disclosed herein, several embodiments are described below in detail with reference to the drawings, which are intended to be used in conjunction with the following detailed description. As is common practice, the drawings may not be to scale, and the dimensions shown may be enlarged or reduced as appropriate. In addition, some components, elements, and / or features may be omitted from some drawings (for example, for clarity). [Brief explanation of the drawing]

[0020] [Figure 1] This is a top perspective view of a fixing device according to one embodiment of the present invention, including the fixing device and frame, and is shown in an open configuration (state / position). [Figure 2] Figure 1 is a top view of the fixation device, shown in a closed configuration and positioned within the patient's access area. [Figure 3] Figure 1 is a top perspective view of the fixing device, shown in a closed configuration (state / position). [Figure 4] Figure 1 is a top view of the fastening device. [Figure 5] This is a side view of an alternative embodiment of the fixing device shown in Figure 1. [Figure 6] This is a top plan view of an alternative embodiment of the fixing device shown in Figure 1. [Figure 7]It is a side plan view of the fixing device of FIG. 6. [Figure 8] It is a top perspective view of an alternative embodiment of the fixture of FIG. 1. [Figure 9] It is a partial top perspective view of an alternative embodiment of the fixing device shown in FIG. 1, including alternative embodiments of the fixture and the cap, with the parts shown separately. [Figure 10] It is a partial top perspective view of the fixing device of FIG. 9 shown in an assembled state. [Figure 11] It is a cross-sectional view taken along line 11-11 of FIG. 9, showing the protrusion on the inner wall of the opening. [Figure 12] It is a bottom perspective view of an alternative embodiment of the cap shown in FIG. 9. [Figure 13] It is a bottom perspective view of an alternative embodiment of the cap shown in FIG. 9. [Figure 14] It is a bottom perspective view of an alternative embodiment of the cap shown in FIG. 13.

Mode for Carrying Out the Invention

[0021] The present invention provides a fixing device configured to receive, guide, and protect one or more wire leads (e.g., a single wire lead or multiple wire leads) during a surgical treatment. More specifically, the fixing device described herein includes a fixture configured to be inserted into an access site of a patient's tissue (e.g., a burr hole in the patient's skull), and a frame coupled to the fixture for the purpose of further securing the wire lead. The fixture in a preferred embodiment includes a body portion that is pivotally coupled, which allows the fixing device to be reconfigured between an open configuration and a closed configuration by manual operation of the frame.By fixing the device, the movement of the wire lead is restricted (limited in some embodiments), fixation is maintained over a period of time, and the potential risks and drawbacks of the above-described wire movement are avoided.

[0022] In addition, the wire lead fixation device allows for a thinner profile, making it more aesthetically acceptable and more suitable for patients who may have thin scalps, thus preventing further risk of skin erosion on the device.

[0023] Next, referring to the drawings and specific embodiments of this disclosure, similar reference numerals will identify similar structural features of the device / system throughout the multiple drawings. Referring first to Figure 1-4, the fixation device of the present invention is shown and is designated collectively by reference numeral 10. The fixation device 10 is configured to be inserted into an access site A (Figure 2) of a patient's tissue T (e.g., a trepanation hole B in the patient's skull S) to fix one or more wire leads W, and includes a fixation fixture 100 and a frame 200. It is assumed that the fixation device 10 (e.g., the fixation fixture 100 and the frame 200) may include (e.g., be formed from) some suitable biocompatible material or combination of materials (either metallic or nonmetallic).

[0024] The fastener 100 is generally cylindrical (tubular) in shape, defining opposite outer (first) end 102 and inner (second) end 104, and the longitudinal axis Y (Figures 2 and 3). The fastener 100 includes a first main body portion 106 that defines inner walls 108 and 110 (Figure 1), and a second main body portion 112 that defines inner walls 114 and 116. The main body sections 106 and 112 are configured to move relative to each other, and the fixing device 10 is reconfigurable between an open configuration (state / position) (Figure 1) in which the inner walls 108 and 110 of the main body section 106 are spaced apart from the inner walls 114 and 116 of the main body section 112, and a closed configuration (state / position) (Figures 2-4) in which the inner walls 108 and 110 of the main body section 106 are positioned adjacent to (e.g., engaged with) the inner walls 114 and 116 of the main body section 112. More specifically, the main body sections 106 and 112 are pivotably connected via a hinge section 118 that extends generally parallel to the longitudinal axis Y. Other methods of connecting the two main body sections 106 and 112 are also being considered, and are not limited to hinged or pivoted connections.

[0025] As can be seen from Figures 1 and 4, each of the main body sections 106 and 112 includes a roughly C-shaped cross-sectional configuration and defines their respective channels 120 and 122. When the fixation device 100 is closed, the main body sections 106 and 112 jointly define a central passage 124 that extends through the fixation device 100. The passage 124 formed by the channels 120 and 122 defines a generally annular cross-sectional configuration and extends (generally) parallel to the longitudinal axis Y. As will be described in more detail below, during use of the fixation device 10, the passage 124 receives (guides) wire leads W, which extend from a target site in the patient, through the fixation device 10 (e.g., fixation device 100), through access site A (e.g., burr hole B), to a location outside the patient.

[0026] The passage 124, formed by the two main body portions 106 and 112, defines an internal cross-sectional dimension D1 (Figure 4) (e.g., diameter) that exceeds, but approximates, the external cross-sectional dimension D2 (e.g., diameter) defined by the wire lead W. For example, it is assumed that the internal cross-sectional dimension D1 of the passage 124 may be about 5% to about 10% larger than the external cross-sectional dimension D2 of the wire lead, but other dimensions are also assumed. However, it should be understood that the specific configuration (e.g., cylindrical with a passage of circular cross-section) and dimensions (e.g., the internal cross-sectional dimension D1 of the passage 124) of the fixing device 10 can be varied in alternative embodiments (e.g., depending on the configuration of the wire lead (singular) W, the specific surgical procedure performed, etc.) without departing from the scope of the present invention. Thus, embodiments of the fixing device 100 in which the passage 124 can define both larger and smaller internal cross-sectional dimensions D1 are also assumed herein.

[0027] The frame 200 is coupled to the fixture 100 and is configured to facilitate manual force application to open and close the fixture 100 while reconfiguring the fixture 10 between an open configuration (state / position) and a closed configuration (state / position). More specifically, the frame 200 includes first and second frame portions 202, 204 which are coupled to the main body portions 106, 112 of the fixture 100 (e.g., at their outer ends 102). More specifically, the main body portions 106, 112 and the frame portions 202, 204 include (defined) their respective corresponding openings 126 (Figure 4), 206 (Figure 2), which are configured to receive fasteners 300i, 300ii (e.g., bolts, screws, rivets, pins, etc.) and thereby mechanically couple the frame 200 to the fixture 100. In addition, the frame 200 will cover the wires and help to secure the fixture to the position of the skull.

[0028] In the illustrated embodiment, the fixture 100 and frame 200 are configured such that a fastener 300i permanently (e.g., immovably) connects frame portion 202 to body portion 106, and a fastener 300ii permanently (e.g., immovably) connects frame portion 204 to body portion 112. However, alternatively, it is envisioned that frame portions 202 and 204 can be movably (e.g., pivotably) connected to body portion 112, respectively, and the frame 200 is pivotable around a pivot axis P (Figure 5) that extends (generally) perpendicular to the longitudinal axis Y relative to the fixture 100. By pivotably connecting frame portions 202 and 204 to their respective body portions 106 and 112, the joint movement of the frame 200 relative to the fixture 100 in the directions indicated by arrows 1 and 2 (Figure 5) is facilitated, thereby enabling high controllability of the fixture 10 during placement, use, and / or removal. Furthermore, embodiments in which frames 200 and 204 are hinge-connected to main body parts 106 and 112 are also envisioned.

[0029] In some embodiments, such as those shown in Figures 1-5, the frame 200 includes one or more latches (locking members) 208 to fix the frame portions 202 and 204 together, thereby stabilizing and locking the fixing device 10 in a closed configuration before, for example, inserting the fixing device 100 into the piercing hole B (Figure 2).

[0030] Each latch 208 extends laterally across the fastening device 10 along a corresponding axis X (Figure 2), preferably oriented substantially perpendicular to the longitudinal axis Y. In the illustrated embodiment, the fastening device 10 includes two latches 208i, 208ii. However, it should be understood that the particular number of latches 208 may be increased or decreased in various embodiments without departing from the scope of the invention (e.g., depending on the configuration of the wire lead(s) W, the particular configuration of the fastening device 10, the particular surgical procedure performed, etc.). Thus, embodiments of the fastening device 10 including both fewer and more latches 208 are envisioned herein, as are embodiments of the fastening device 10 without any latches 208. It is also envisioned that the latches may have play for conduits that will cover the wire to further fasten the wire.

[0031] Each of the latches 208 includes opposite (first and second) ends 210, 212 and is coupled (engaged) to frame portions 202, 204. More specifically, in the illustrated embodiment, latch 208i includes a first end 210i coupled (engaged) to frame portion 204 by fastener 300iii and a free second end 212i configured to engage (couple) to frame portion 202 by mechanical fastener 300iv; latch 208ii includes a first end 210ii coupled (engaged) to frame portion 202 by mechanical fastener 300v and a free second end 210ii configured to engage (couple) to frame portion 204 by mechanical fastener 300vi. Embodiments without one or more of fasteners 300iii-300vi are also envisioned herein and are not beyond the scope of the invention. For example, the respective ends 210i, 210ii of latches 208i, 208ii may be formed integrally (e.g., integrally, singlely) with the frame portions 204, 202 (e.g., so that the latches 208i, 208ii and the frame portions 202, 204 are formed from a single material), and the respective ends 212i, 212ii of latches 208i, 208ii may be configured to mechanically engage with the frame portions 202, 204 by including a corresponding engaging structure. Exemplarily, it is envisioned that the respective ends 212i, 212ii of latches 208i, 208ii may include a detent configured for insertion into a corresponding recess defined by the frame portions 202, 204, or that the respective ends 212i, 212ii of latches 208i, 208ii may include a recess configured to receive a corresponding detent defined by the frame portions 202, 204.

[0032] In some embodiments, as shown in Figures 6 and 7, the latch 208 includes a recess 214 configured to receive the wire lead(s) W in order to protect and guide the wire lead(s) W away from the patient by preventing excessive force from being applied to the wire lead(s) W, and thus preventing (if not completely) bending, twisting, torsion, etc. of the wire lead(s) W. More specifically, the recess 214 extends (perpendicularly) into the latch 208 in a relationship that is (generally) orthogonal to axis X and (generally) parallel to the longitudinal axis Y defined by the fastener 100.

[0033] In some embodiments, as shown in Figure 8, the fastener 100 may include a recess 128 at its end 102 configured to receive a wire lead(s) W. The recess 128 communicates with and extends from a passage 124, receiving the wire lead(s) W as they exit the fastener 100, further suppressing excessive force on the wire lead(s) W, and suppressing (but not completely preventing) bending, twisting, and other such deformations of the wire lead(s) W. More specifically, the recess 128 is collectively defined by a (first) recess 130 included in the main body portion 106 and a (second) recess 132 included in the main body portion 112.

[0034] Referring again to Figure 1-4, the use of the fixation device 10 during surgical treatment in which one or more wire leads W are inserted into the patient to achieve a therapeutic effect is described. The wire leads can be used to transmit therapeutic electrical stimuli or to record brain activity for diagnostic and neurological monitoring purposes.

[0035] First, the wire lead W is inserted through access site A (Figure 2) (e.g., burr hole B) and advanced to the target site (e.g., inside the patient's skull S). Then, using the fixation device 10 in an open configuration (Figure 1), the wire lead W is positioned between the main body portions 106 and 112 of the fixation device 100 (e.g., within the path 120 defined by the main body portion 106 and / or within the path 122 defined by the main body portion 112). With the wire lead W in place, the fixation device 10 is moved from the open configuration to the closed configuration (Figure 2-4) by manually applying force to the frame portions 202 and 204, which can be facilitated by the pivoting of the frame 200 around the pivot axis P (Figure 5). More specifically, inward forces F1, F2 (Figure 1) are applied to frame portions 202, 204, and these forces are transmitted to the respective body portions 106, 112 via joints established by fasteners 300i, 300ii, respectively. Alternatively, frame portions 202, 204 are manufactured as part of the body portions 106, 112, and after the body portions 106, 112 are hinged together to secure the wire, the frame portions 202, 204 are further hinged over the wire to further secure the wire and also fix the entire structure to the skull. Thus, the body portions 106, 112 pivot around the hinge portion 118 until the inner walls 108, 110 of body portion 106 are positioned adjacent to (e.g., until they engage (contact)) the inner walls 114, 116 of body portion 112, respectively, thereby holding the wire lead W within the passage 124. Depending on the specific configuration of the fixation device 100 and the wire lead W (e.g., specific dimensions D1 (Figure 4), D2 (Figure 2)), it is assumed that closing the fixation device 10 will cause engagement (contact) between the fixation device 100 (e.g., main body portions 106, 112) and the wire lead W, thereby restricting (if not completely preventing) relative movement between them. Alternatively, it is assumed that the wire lead W will be able to move freely within the passage 124 when the fixation device 10 is closed (e.g., to allow for forward, backward, or other such repositioning of the wire lead W during the course of surgical treatment).

[0036] Following the closure of the fastener 100, the fastening device 10 can be locked into a closed configuration via the engagement of latches 208i, 208ii with their respective frame portions 202, 204 (for example, via the insertion of fasteners 300iii, 300iv, 300v, 300vi (Figure 2) into the frame portions 202, 204 through latches 208i, 208ii), or as described above, and the fastener 100 can be inserted into access area A (Figure 2) (for example, trepanation hole B).

[0037] In one method of use, to further secure the fixation device 100 within the burr hole B, thereby restricting (if not completely preventing) the movement of the fixation device 10 (and wire leads W) relative to the patient, fasteners 300iii, 300iv, 300v, and 300vi can be advanced through the frame 200 into the patient's tissue (e.g., the patient's skull S (Figure 2)). Alternatively, it is envisioned that one or more additional fasteners may be used to fix the fixation device 10 in place. For example, additional fasteners may be inserted and advanced into the patient's tissue through the fixation device 100 (e.g., through body portion 106 and / or body portion 112) or through the frame 200 (e.g., through frame portion 202 and / or frame portion 204).

[0038] Referring now to Figure 9-11, another embodiment of the fixing device 10 is shown, which is identified by reference numeral 20. Fixing device 20 is substantially similar to fixing device 10 (Figure 1-4) in both structure and function, and therefore, for brevity, only the differences will be described. For this reason, the same reference numerals will be used to refer to elements, structures, features, etc., common to fixing devices 10 and 20.

[0039] In addition to the frame 200, which is omitted from Figure 9-11 for clarity, the fixing device 20 includes a fastener 400 and a cap 500 configured to engage with (connect) the fastener 400 to further secure the fixing device 20 within the burr hole B.

[0040] The fastener 400 is substantially similar to the fastener 100 (Figure 1-4) described above, but has a longitudinal opening 434 extending into the main body portions 106, 112 (generally) parallel to the longitudinal axis Y. Alternatively, the opening 434 can be angled slightly inward toward the longitudinal axis. In the illustrated embodiment, it is shown to include a pair of openings 434i, 434ii, but it should be understood that the particular number of openings 434 can be increased without departing from the scope of the invention (for example, depending on the configuration of the wire lead W (Figure 1-3), the specific surgical procedure performed, etc.). Thus, embodiments of the fastener 400 including three or more openings 434 are also envisioned herein.

[0041] The cap 500 includes a collar 502 and a pair of legs (fins) 504. The cap 500 defines a window or opening 506 configured to receive wire leads W, so that when the fixing device 20 is assembled, the wire leads W extend from the fixing device 400 through the collar 502. In the illustrated embodiment, each of the collar 502 and the window 506 is (generally) annular (e.g., circular) in configuration. However, it should be understood that the specific configuration of the collar 502 and / or the window 506 can be modified in various embodiments without departing from the scope of this disclosure (e.g., depending on the configuration of the wire leads W, the configuration of the fixing device 400, etc.).

[0042] The legs 504 extend perpendicularly (downward in the orientation of Figure 9) from the collar 502 in a relationship (generally) parallel to the longitudinal axis Y, and are configured to be inserted into the openings 434 of the main body portions 106, 112. Although the illustrated embodiments are shown to include a pair of legs 504i, 504ii, it should be understood that the particular number of legs 504 can be increased without departing from the scope of this disclosure (for example, depending on the configuration of the fastener 400). Thus, embodiments of the cap including three or four or more legs 504 are also envisioned herein. The openings 434 of the main body portions will preferably correspond to the number of legs 504.

[0043] The cap 500 is made of an elastic (flexible, deformable) material (either metal or nonmetal), and when the cap 500 is coupled to the fastener 400 in a closed configuration (for example, when the legs 504 are inserted into the fastener 400), biasing forces B1 and B2 are generated by the contact (engagement) between the cap 500 and the fastener 400, as shown in Figure 10. These biasing forces B1 and B2 are directed radially outward and transmitted to the main body portions 106 and 112 of the fastener 400 to further secure the fastener 400 and effectively lock the fastener 20 into the access area A (Figure 2) (for example, the piercing hole B). The opening 434 and the legs 504 can be configured, for example, so that when the legs are inserted, they press against the angled opening wall towards a position parallel to the normal, applying an outward force. In another example, a projection on the wall of the opening can deflect the leg inward toward the passageway, generating outward biasing forces B1 and B2.

[0044] In an alternative embodiment, the main body portions 106 and 112 include a number of projections (e.g., retainers, ribs, etc.) located within the passage 124. The projections are configured to engage (contact) with the wire lead to enhance the fixation of the wire lead, for example, by increasing the frictional engagement. The projection 436 in Figure 11 can be utilized within the passage 124.

[0045] Additionally or alternatively, projections 436 (e.g., stoppers, ribs, etc.) can be provided within the openings 434 of the main body portions 106, 112, which will impart a force to the leg portion 504 that biases the fixing half inward to enhance the grip of the wire lead. Such projections 436 may be on the outer walls of the openings 434i, 434ii.

[0046] Additionally or alternatively, the projection 436 may be provided within the opening 434 to engage (contact) with the leg portion 504, deflecting the leg portion 504 outward, thereby strengthening the outward biasing force and reinforcing the fixation of the fastener within the piercing hole. Such projections may be located on the inner walls of the openings 434i, 434ii (see Figure 11).

[0047] As can be seen in Figure 12, in addition to or instead of the protrusion 436 included in the opening 434, the outer surface 510 of the leg portion 504 also includes one or more protrusions 508 (e.g., retainers, ribs, etc.) which can provide an inward biasing force or generate an outward biasing force.

[0048] Figure 13 shows another embodiment of the cap 500, identified by reference numeral 600. The cap 600 is substantially similar to the cap 500 described above (Figure 9-11) in both structure and function; therefore, for brevity, only the differences will be described. For this reason, the same reference numerals will be used to refer to elements, structures, features, etc., common to both caps 500 and 600.

[0049] In contrast to the cap 500, whose legs 504 extend (perpendicularly) from the collar 502 in a relationship parallel to the longitudinal axis Y, the legs 504 of the cap 600 extend from the collar 502 in a relationship nonparallel to the longitudinal axis Y, such that each leg 504 makes an (acute) angle α with the longitudinal axis Y. In the illustrated embodiment, the cap 600 is configured such that the angle α is (substantially) in the range of (approximately) 5 degrees to (approximately) 45 degrees, but other ranges are also intended.

[0050] Due to the angled configuration of the leg portion 504, when inserted into the opening 434 (Figure 9), the leg portion 504 is deflected radially inward (for example, in the direction of the passage 124), thereby generating the biasing forces B1 and B2 (Figure 10) described above. For this reason, the biasing forces B1 and B2 can be changed by changing a specific angle α that the leg portion 504 extends with respect to the longitudinal axis Y. More specifically, increasing the angle α applies an increased outward biasing force B1 and B2 to the main body portions 106 and 112, and therefore to the piercing hole B, while decreasing the angle α applies a reduced biasing force B1 and B2.

[0051] To further increase the biasing forces B1 and B2, in some embodiments as shown in Figure 14, the cap 600 may include the aforementioned projection 508 on the outer surface 510 of the leg portion 504, and / or the projection may be included within the opening 434.

[0052] The systems, components, and methods described herein relate to some embodiments of the present disclosure, but those skilled in the art will readily understand that modifications and alterations can be made without departing from the spirit and scope of the invention as defined by the appended claims. Those skilled in the art will understand that the various embodiments of the present disclosure described herein and shown in the appended drawings constitute non-limiting examples, and that additional components and features can be added to any of the embodiments discussed herein without departing from the scope of the invention.

[0053] Note that while the device is configured to accept a single wire lead, it is also intended to be able to accept two or more wire leads.

[0054] Those skilled in the art will understand that the specific embodiments described above are shown and explained for illustrative purposes only. The principles and features of this disclosure can be used in a variety of embodiments without departing from the scope and spirit of the invention as set forth in the claims. The embodiments described above do not limit the scope of the invention.

[0055] Furthermore, those skilled in the art will understand that elements and features shown or described in relation to one embodiment can be combined with those of another embodiment without departing from the scope of the present invention.

[0056] Throughout this disclosure, terms such as “approximately,” “about,” “generally,” and “substantially” should be understood to allow for some variation in any numerical range or concept in which they relate, encompassing a variation of about 25% (e.g., to allow for manufacturing tolerances and / or design deviations). For example, the term “generally parallel” should be understood to refer to a configuration in which the relevant components are oriented to define an angle equal to 180° ± 25% (an angle within the range of (approximately) 135° to (approximately) 225°) between them, and the term “generally orthogonal” should be understood to refer to a configuration in which the relevant components are oriented to define an angle equal to 90° ± 25% (e.g., an angle within the range of (approximately) 67.5° to (approximately) 112.5°) between them.

[0057] When specifying a numerical range based on endpoints, all numerical values ​​within that range must be included.

[0058] Terms such as “first,” “second,” and “third” may be used herein to describe various operations, elements, components, areas, and / or sections, but these operations, elements, components, areas, and / or sections should not be limited by the use of these terms in that they are used to distinguish one operation, element, component, area, or section from another. Accordingly, unless expressly stated otherwise, the first operation, element, component, area, or section may be referred to as the second operation, element, component, area, or section without departing from the scope of this disclosure.

[0059] Each and all claims are incorporated herein as further disclosures and represent embodiments of the present disclosure. The expressions “at least one of A, B, and C” and “A and / or B and / or C” should be interpreted as including A alone, B alone, C alone, or any combination of A, B, and C, respectively. [Explanation of Symbols]

[0060] 10 Fixation device 100 Fixtures 102 Outer (first) end 104 Inner (second) end 106 Main body part 108 Inner wall 110 Interior wall 114 Interior wall 116 Interior wall 118 Hinge section 120 routes 122 routes 200 frames 202 Frame section 204 Frame section 208 Latch 210 End 212 End 300 fasteners

Claims

1. A fixation device configured to receive wire leads during surgical treatment, The aforementioned fixation device comprises a fixation device configured to define a longitudinal axis and be inserted into the patient's access site, The aforementioned fixing device is The first main body part, A second main body portion is movably coupled to the first main body portion, and the fixing device is reconfigurable between an open configuration and a closed configuration. Includes, The aforementioned fixing device further, A fixing device comprising a frame, which is coupled to the fixing device and configured to facilitate the reconfiguration of the fixing device between the open configuration and the closed configuration.

2. The fixing device according to claim 1, wherein the first main body portion and the second main body portion are joined by a hinge portion that extends generally parallel to the longitudinal axis.

3. The aforementioned frame is A first frame portion connected to the first main body portion, A second frame portion connected to the second main body portion, The fixing device according to claim 1, including the following:

4. The fixing device according to claim 3, wherein the first frame portion is pivotable relative to the first main body portion, and the second frame portion is pivotable relative to the second main body portion.

5. The fixing device according to claim 1, wherein the frame includes one or more latches configured to lock the fixing device in the closed configuration.

6. The fixing device according to claim 5, wherein the latch includes a recess configured to receive one or more wire leads in order to guide one or more wire leads away from the patient.

7. The fixing device according to claim 1, further comprising a cap configured to engage with the fixing device and further fixing the fixing device within the access portion.

8. The fixing device according to claim 7, wherein the cap includes an elastic material and generates a radially outward biasing force when the cap is connected to the fixing device.

9. The fixing device according to claim 8, wherein the cap includes a first leg configured to be inserted into the first body portion and a second leg configured to be inserted into the second body portion, and when the cap is connected to the fixing device, the first leg extends into the first body portion and the second leg extends into the second body portion.

10. The fixing device according to claim 9, wherein the first leg and the second leg extend non-parallel to the longitudinal axis.

11. A fixation device configured to receive wire leads during surgical treatment, The aforementioned fixation device comprises a fixation device that defines a longitudinal axis and is configured to be inserted into a trepanation hole in the patient's skull, The fixing device includes first and second body portions defining an inner wall, the first and second body portions being configured to move relative to each other, and the fixing device is reconfigurable between an open configuration in which the inner walls of the first and second body portions are separated and a closed configuration in which the inner walls of the first and second body portions are adjacent to each other and the first and second body portions jointly define a passage configured to receive the wire lead.

12. The fixing device according to claim 11, further comprising a frame coupled to the fixing device and configured to facilitate the reconfiguration of the fixing device between the open configuration and the closed configuration.

13. The fixing device according to claim 11, wherein the fixing device includes a recess that communicates with the passage and is configured to receive the wire lead and prevent excessive force from being applied to the wire lead.

14. The fixing device according to claim 12, wherein the first and second main body portions are generally C-shaped.

15. The fixing device according to claim 11, wherein the frame includes one or more latches configured to lock the fixing device in the closed configuration, and the one or more latches extend laterally across the fixing device in a relationship generally perpendicular to the longitudinal axis.

16. A method of performing surgical treatment, Positioning the wire lead between the first main body portion and the second main body portion of the fixing device, Reconfiguring the fixing device from an open configuration to a closed configuration, thereby holding the wire lead inside the fixing device, The aforementioned fixing device is locked in the aforementioned closed configuration, Inserting the aforementioned fixing device into the access site, Methods that include...

17. The method according to claim 16, wherein reconfiguring the fixing device from the open configuration to the closed configuration includes pivoting the first body portion and the second body portion around the hinge portion.

18. The method according to claim 16, further comprising coupling a cap to the fixing device in order to further fix the fixing device within the access portion.

19. The method according to claim 18, wherein connecting the cap to the fixing device includes connecting the cap to the fixing device such that the wire lead extends through the cap.

20. The method according to claim 18, wherein connecting the cap to the fixing device includes inserting the legs of the cap into the openings of the first body portion and the second body portion, thereby biasing the first body portion and the second body portion radially outward.

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