Surgical guide with guide system socket

Abstract

A surgical guide system having side walls forming a guide passage and a probe socket at the distal end of the guide. The probe socket has an inner surface having a first transverse dimension at a proximal socket end and a second transverse dimension in a transverse direction at a distal socket end, and the first transverse dimension is greater than the second transverse dimension. The inner surface receives the distal end of a navigation probe and limits movement of the distal probe end in a transverse direction, and the side wall is spaced from the navigation probe shaft to allow the shaft to move in a transverse direction within the passage when the distal probe end is positioned in the probe socket.

Description

[0001] This application is a divisional application of the invention patent application of Vick Medical Co., Ltd. (the application date is November 7, 2017, the application number is 201780082607.0, and the invention name is "Surgical guide with guide system socket").

[0002] This application claims priority to U.S. Provisional Application No. 62 / 418,507, filed on November 7, 2016, entitled “SURGICAL INTRODUCER WITH GUIDANCE SYSTEM RECEPTACLE,” and U.S. Patent Application No. 15 / 372,890, filed on December 8, 2016, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to a delicate tissue surgical retractor system for use on the brain or other tissue susceptible to injury by retraction. Background Art

[0004] Various devices have been used to retract delicate tissue during surgery. One such device is shown in U.S. Patent Publication No. 2010 / 0010315, which is incorporated herein by reference. Figure 1 A soft tissue retractor system is shown having a hollow retractor 100 and an introducer 102 that is selectively inserted into the retractor 100. The retractor 100 and / or the introducer 102 may include a handle 104 to facilitate manipulation and placement of the retractor system, and a lock to hold the introducer and retractor together. The handle 104 is configured to be connected to a clamp 106, such as Figure 1 A standard surgical clamp 106 is shown in FIG. Figure 1 The device in (with some modifications) is commercially available as the "VBAS" device by Vycor Medical, Inc. of Boca Raton, Florida.

[0005] like Figure 1The retractor system shown is often used by inserting the introducer 102 into the retractor 100 and locking it in place so that the two can be moved and manipulated as a unit. The combined retractor system is inserted into the patient and moved to the surgical site, and then the introducer 102 is unlocked and removed to allow access to the site by the retractor 100. When the unit is in place (before or after the introducer 102 is removed), the handle 104 can be locked to the clamp 106 to hold the retractor 100 in place. Surgeons using the retractor sometimes do not use a clamp to hold the retractor at the surgical site, and often manually manipulate the retractor during surgery to access different parts of the surgical site. The retractor system and retractor can be manipulated by grasping the proximal end of the introducer or retractor or by grasping the handle.

[0006] Figure 1 The device shown in can have a transparent guide 102 and / or a retractor 100, and the surgeon using such a device advantageously uses the transparent guide and retractor to observe the underlying tissue and visually guide the unit to the surgical site. Although it has been found that visual guidance through the guide 102 is very beneficial, it has also been found that some form of additional guidance or navigation may be required in some cases. For example, in some cases, the surgeon uses a probe or a guide wire (narrow slender rod) to guide the movement of the retractor system. In this case, the probe is advanced to the surgical site, and then the interlocking retractor system slides on the probe until it reaches the surgical site. It is easy to adapt around the probe by including a hole at the end of the guide. If there is no hole through the end of the guide, this method cannot be used. This type of system is described in U.S. Patent Publication Nos. 2008 / 0109026 and 2009 / 0048622, which are incorporated by reference into this application. These references also show another configuration in which the retractor is not locked to the guide.

[0007] It has been found that some surgeons using the above process can use a probe integrated into a computer navigation system. For example, the probe can include a so-called "starburst" or the like on the near end of the probe (i.e., the end opposite to the distal end inserted into the surgical site). This navigation system and other navigation systems are known in the art. For example, frameless navigation systems and other computerized guidance systems and methods are described in U.S. Publication No. 2001 / 0027271 (the entire contents of which are incorporated herein by reference) and other disclosures, and are commercially available from companies such as Medtronic, Inc, Stryker, BrainLab, AG, and GE Healthcare. As used in this application, "computerized guidance" includes any method that relies on computer visualization and / or control to guide the device to the surgical site or at the surgical site.

[0008] U.S. Patent Publication No. 2010 / 0010315 briefly describes the possibility of using stereotactic guidance or navigation in conjunction with a surgical retractor, but does not show or describe the procedure or any instrumentation for accomplishing this purpose. However, surgeons are known to use a navigation probe with a VBAS device "freehand," such as Figure 1 As shown. In this case, the surgeon holds the navigation probe in place within the introducer while advancing the unit toward the surgical site. The end of the probe can be placed in or near the opening through the end of the introducer, but the opening through the introducer can be slightly larger than the probe end and is oval, and the probe end is not held in any particular orientation. This technique can suffer from inaccuracies and displacements of the probe from the end of the introducer, and it can be difficult to hold the probe in place. Moreover, in some cases, the probe end can partially extend through the introducer end opening, which can risk damaging the underlying tissue. However, freehand use may help to occasionally remove the probe to provide an unobstructed view of the underlying tissue through the introducer.

[0009] Although computerized surgical guidance systems are well known, there are many limitations to their use with retractor systems, particularly for surgical procedures such as Figure 1 Those systems shown. For example, while some surgeons use computerized guidance to guide the probe to the surgical site and then slide the retractor system over the probe to the surgical site, the movement of the retractor can be somewhat imprecise and the step can be overly cumbersome. This approach is also unusable if the retractor system is not adapted to fit through a through hole on the probe (either because there is no hole or the hole is too small). In addition, the probe does not provide a view of the tissue it is advancing through, so there is no visual way to sense and avoid critical tissue (e.g., major blood vessels or nerves) when inserting the probe prior to inserting the retractor / introducer system. Moreover, a small diameter probe can cut through delicate tissue cells, such as gray or white matter of the brain, rather than moving the cells aside and passing between the cells as expected when advancing the retractor system.

[0010] U.S. Patent Publication No. 2013 / 0066154, incorporated herein by reference, shows an example of a system for integrating a navigation probe into a surgical guide. Figure 1- Figure 6 shows a navigation probe that is secured to the interior of a pre-existing guide by an elastic device such as a rubber plug or O-ring. Another embodiment uses a sliding adapter (such as Figures 7-8), while another embodiment uses an arm to hold the probe down within the guide (Figure 9). Still other versions mount the navigation device outside the guide, mounted to an arm connected to the retractor assembly (Figures 10-11). While these systems can provide suitable performance, they also have certain potential disadvantages. For example, the elastic plug may slip in the presence of fluid and may be difficult to disengage during surgery to remove the navigation device, the sliding adapter requires careful monitoring to ensure proper positioning, the arm that holds the probe in place as shown in Figure 9 requires modification of the probe to include a surface that the arm pushes against, and positioning the navigation device outside the guide complicates the correlation between the navigation device and the end of the guide or retractor.

[0011] U.S. Patent Publication No. 2012 / 0071748, incorporated herein by reference, shows another example of a system for integrating a navigation probe into a surgical guide. In this case, the probe is retained in a narrow passage through the guide and held in place with a threaded locking screw. The locking screw adds an additional movable component to the operating room, so this reference adds a separate retention device (see Figure 7B ) to prevent the locking screw from being removed. Locking screws can also be relatively difficult to manipulate, especially while wearing surgical gloves.

[0012] U.S. Patent Publication No. 2016 / 0015374, which is incorporated by reference into the present application, also shows another example of a system for integrating a navigation probe into a surgical guide. The device shown in the disclosure holds the probe in a tubular sheath that extends distally from the proximal open end of the guide into the guide, and has a convenient single-throw clamp to lock the probe in place. The device also optionally includes a mechanism for indicating when the navigation probe is fully located in the guide. Although the device is useful for ensuring higher accuracy and registration between the guide and the navigation probe, it may hinder the surgeon's field of view to some extent, and may make the frequent removal and reinstallation of the navigation probe somewhat troublesome compared to using the probe with bare hands.

[0013] It has been discovered that there remains a need to provide alternative instruments and methods for coordinating the use of a guidance system with a surgical guide. Summary of the invention

[0014] In one exemplary aspect, there is provided an introducer system for use with a navigation probe, the navigation probe having a navigation element and a navigation probe shaft, the navigation probe shaft having a diameter and terminating at a distal probe end. The introducer system includes a side wall extending along a longitudinal axis and forming an introducer passage extending from a proximal introducer end to a distal introducer end, the side wall being larger than the diameter of the navigation probe shaft in a transverse direction orthogonal to the longitudinal axis. The introducer also includes a probe socket located at the distal introducer end, the probe socket extending from the proximal socket end to the distal socket end in the introducer passage along the longitudinal axis, the probe socket having an inner surface, the inner surface having a first transverse dimension in a transverse direction at the proximal socket end and a second transverse dimension in a transverse direction at the distal socket end, the first transverse dimension being larger than the second transverse dimension. The configuration and size of the inner surface are designed to receive the distal probe end and limit the movement of the distal probe end in a transverse direction, and the configuration and size of the side wall are designed to allow the navigation probe shaft to move laterally in the passage when the distal probe end is positioned in the probe socket.

[0015] The sidewall may have an elliptical profile in the lateral direction, and the probe receptacle may have a circular profile in the lateral direction.The sidewall may have a profile in the lateral direction, and the probe receptacle may be located at a geometric center of the sidewall profile.

[0016] The inner surface may have a proximal portion adjacent to the proximal socket end, the proximal portion having a first angle relative to the longitudinal axis, and a middle portion where the upper portion is distally positioned and has a second angle relative to the longitudinal axis, the second angle being less than the first angle. The first angle may be 20°-30°, and the second angle may be 5°-15°. The inner surface may also include a distal portion distally positioned from the middle portion, the distal portion forming at least a portion of the hemispherical surface.

[0017] The probe socket may have a distal socket opening that passes through the distal socket end and forms a first fluid flow path between the inner surface and the exterior of the sidewall at the distal introducer end. The introducer may also include an introducer tip opening that forms a second fluid flow path between the introducer passage and the exterior of the sidewall at the distal introducer end.

[0018] At least a portion of the probe socket may be spaced apart from the side wall by a gap in the lateral direction.The probe socket may have at least one opening at a position between the socket proximal end and the socket distal end, forming a fluid communication path between the inner surface and the gap.

[0019] The introducer may have an introducer end opening that forms a fluid flow path through the side wall at the distal introducer end. At least a portion of the probe socket may be spaced apart from the side wall by a gap in the lateral direction. At least one passage may be provided through the outer wall of the probe socket between the proximal end of the socket and the distal end of the socket, the at least one passage forming a fluid communication path between the introducer end opening and the gap, the fluid communication path being configured to at least partially bypass the proximal socket end. The at least one passage may be a plurality of notches extending through the outer wall of the probe socket, each of the plurality of notches extending from the proximal socket end to a portion of the side wall located adjacent to the distal socket end along the longitudinal axis. The introducer may have at least one passage through the inner surface to the introducer end opening, and the at least one passage may include one or more annular passages.

[0020] When viewed along the longitudinal axis, the probe socket can cover the introducer end opening, and the introducer can also include at least one fluid flow path that extends through the introducer end opening without passing through the proximal socket end. The introducer can have one or more supports extending between the sidewall and the probe socket so that the probe socket is suspended adjacent to the introducer end opening. The one or more supports can be a plurality of ribs extending along the longitudinal axis. The distal socket end can be located in the introducer end opening. At least a portion of the one or more supports can be located in the introducer end opening. The probe socket can be smaller or larger than the introducer end opening in a transverse direction.

[0021] The inner surface can be configured to hold the distal probe tip adjacent to the distal introducer end. The inner surface can be configured to hold the distal probe tip within 1.0 mm or within 0.5 mm of the distal introducer end. The inner surface can be configured to hold at least four different navigation probes, each having a distal probe tip, each having a different geometry than the other navigation probes, each distal probe tip being within 1.0 mm or within 0.5 mm of the distal introducer end when fully installed in the probe receptacle.

[0022] When the navigation probe is installed within the introducer, at least a portion of the sidewall at the distal introducer end can be transparent and visible from the proximal introducer end.

[0023] The introducer system may further include a stylet retainer configured to be selectively connected to the proximal introducer end. The stylet retainer has a receiver configured to receive the navigation stylet shaft when the stylet retainer is attached to the proximal introducer end, thereby limiting movement of the navigation stylet shaft in a lateral direction.

[0024] In another exemplary embodiment, there is provided a guide system for use with a navigation probe, the navigation probe having a navigation element and a navigation probe shaft, the navigation probe shaft having a diameter and terminating at a distal probe end. The guide system has a guide, the guide having a side wall and a probe socket, the side wall extending along the longitudinal axis and forming a guide passage extending from a proximal guide end to a distal guide end, the side wall being larger than the navigation probe shaft diameter in a transverse direction orthogonal to the longitudinal axis, the probe socket being located at the distal guide end, the probe socket extending from the proximal socket end to the distal socket end in the guide passage along the longitudinal axis, the probe socket having an inner surface, the inner surface having a first transverse dimension in a transverse direction at the proximal socket end and a second transverse dimension in a transverse direction at the distal socket end, the first transverse dimension being larger than the second transverse dimension. The guide system also includes a probe retainer, the probe retainer being configured to be selectively connected to the proximal guide end. The probe retainer includes a receiver, the receiver being configured to receive the navigation probe shaft and limit the movement of the navigation probe shaft in a transverse direction.

[0025] The probe retainer can have one or more clamps connected to the receiver and configured to selectively connect to the proximal guide end. The one or more clamps can be two clamps, each clamp connected to the receiver by a clamp arm, the clamp arm having an arm opening passing therethrough, and each arm opening is aligned with the guide passage to provide a visual path into the guide passage. The receiver can have a locking piece to selectively retain the navigation probe shaft.

[0026] In another exemplary aspect, there is provided a guide system for use with a navigation probe, the navigation probe having a navigation element and a navigation probe shaft, the navigation probe shaft having a diameter and terminating at a distal probe end. The guide system includes a guide and a probe retainer. The guide has a side wall extending along the longitudinal axis and forming a guide passage extending from the proximal guide end to the distal guide end, the guide passage being larger than the navigation probe shaft diameter in a transverse direction orthogonal to the longitudinal axis. The probe retainer is configured to be selectively connected to the proximal guide end. The probe retainer includes: a receiver configured to receive the navigation probe shaft and limit the movement of the navigation probe shaft in the transverse direction; and a first clamp and a second clamp, the first clamp and the second clamp are connected to the receiver, the receiver is located between the first clamp and the second clamp, each of the first clamp and the second clamp selectively engages with a corresponding portion of the side wall to keep the receiver in a fixed position relative to the guide. The receiver, the first clamp and the second clamp are configured to provide a visual path through the probe retainer and into the guide passage.

[0027] Each of the first and second clamps can be connected to the receiver by a respective clamp arm, each clamp arm having an opening therethrough that aligns with the introducer passage to form a respective portion of the visualization path through the probe retainer.

[0028] Each of the first and second clamps may be connected to the receiver by a corresponding clamp arm and may include a tab and a hook, the tab extending from the clamp arm in a first direction and the hook extending from the clamp arm in a second direction, the second direction being generally opposite to the first direction. The first and second clamps may be connected to the receiver by corresponding flexible connectors, each of which may be movable to allow the corresponding tab to move toward the receiver and to allow the corresponding hook to move away from the receiver to release the corresponding hook from engagement with the side wall. The flexible connector may be a bendable clamp arm. The side wall may have one or more outwardly extending flanges at the proximal guide end, the one or more outwardly extending flanges having a first portion positioned to engage with the corresponding hook of the first clamp and a second portion positioned to engage with the corresponding hook of the second clamp.

[0029] The receiver may have a lock to selectively hold the navigation probe shaft from moving along the longitudinal axis. The lock may have a first threaded member having an internal passage having a first tapered surface; a second threaded member having an outer body and an internal passage, the outer body having a second tapered surface adapted to the first tapered surface, the internal passage being sized to receive the navigation probe shaft; wherein relative rotation between the first threaded member and the second threaded member moves the first tapered surface toward the second tapered surface to compress the internal passage to hold the navigation probe shaft. The second tapered surface may have one or more notches extending in the longitudinal direction.

[0030] The first threaded member may have a hollow passage connected to move with the first and second clamps, and the second threaded member may have a knob portion connected to the second tapered surface. The probe retainer may have one or more hooks positioned to engage a flange on the second threaded member to prevent the second threaded member from separating from the first threaded member.

[0031] The second threaded member may be connected to move with the first and second clamps, and the first threaded member may be a knob portion connected to the first tapered surface. The probe retainer may have one or more hooks positioned to engage a flange on the first threaded member to prevent the first threaded member from separating from the second threaded member.

[0032] The receiver can have a receiver passage extending along the longitudinal axis from a proximal receiver passage end to a distal receiver passage end, the proximal receiver passage end being at a position relatively close to the proximal introducer end, the distal receiver passage end being at a position relatively close to the distal introducer end, and the receiver includes one or more notches along the longitudinal axis at the distal receiver passage end. The inner diameter of the receiver passage can taper to a smaller size at the distal receiver passage end.

[0033] The introducer may have a probe socket located at the distal introducer end, the probe socket extending from the proximal socket end to the distal socket end within the introducer passage along the longitudinal axis, the probe socket having an inner surface, the inner surface having a first transverse dimension in the transverse direction at the proximal socket end and a second transverse dimension in the transverse direction at the distal socket end, the first transverse dimension being greater than the second transverse dimension. The probe socket may have a distal socket opening that passes through the distal socket end and forms a first fluid flow path between the inner surface at the distal introducer end and the exterior of the sidewall. At least a portion of the probe socket may be spaced apart from the sidewall in the transverse direction by a gap. The probe socket may have at least one opening at a position between the proximal end of the socket and the distal end of the socket, and a fluid communication path is formed between the inner surface and the gap.

[0034] The introducer may have an introducer tip opening forming a fluid flow path through the sidewall at the distal introducer end.

[0035] The preceding summary of the invention provides various exemplary embodiments which can be used in any suitable combination and is not intended to impose any limitations on the invention described in the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The exemplary embodiments may be better understood by referring to the drawings, in which like reference numerals represent like components. The drawings are exemplary and are not intended to limit the claims in any way.

[0037] Figure 1 is an example of a prior art fine tissue retractor system.

[0038] Figure 2A is a cross-sectional side view of a first embodiment of an introducer having a guide probe receptacle.

[0039] Figure 2B yes Figure 2A A cross-sectional side view of the distal tip of an embodiment of the present invention is shown at a slightly oblique angle.

[0040] Figure 3AThe distal tip of another embodiment of an introducer having a guide probe receptacle is shown as viewed from within the introducer.

[0041] Figure 3B yes Figure 3A A cross-sectional side view of the distal tip of an embodiment of.

[0042] Figure 4A The distal tip of another embodiment of an introducer having a guide probe receptacle is shown as viewed from within the introducer.

[0043] Figure 4B yes Figure 4A A cross-sectional side view of the distal tip of an embodiment of.

[0044] Figure 5A The distal tip of another embodiment of an introducer having a guide probe receptacle is shown as viewed from within the introducer.

[0045] Figure 5B Shown is the view from outside the introducer Figure 5A Embodiment of the invention.

[0046] Figure 5C yes Figure 5A A cross-sectional side view of the distal tip of an embodiment shown along line 5C-5C.

[0047] Figure 5D yes Figure 5A A cross-sectional side view of the distal tip of an embodiment shown along line 5D-5D.

[0048] Figure 6A-6D are cross-sectional side views of the distal tips of four different navigation probes.

[0049] Figure 7A-7B Embodiments of centering devices that may be used with embodiments of introducers are shown.

[0050] Figure 8A-B Shows the use of Figure 7A-7B Embodiment of the invention.

[0051] Fig. 9A and Fig. 9B Assembled and exploded views, respectively, of alternative embodiments of the centering device and probe retainer system. DETAILED DESCRIPTION

[0052] Embodiments of the present invention may provide various features to supplement or improve the surgical guide and retractor systems of the prior art. As used herein, the term "guidance system" is intended to include any system for assisting a surgeon in advancing a retractor system to a surgical site, and may include passive systems like guidewires, or active systems like navigation probes detected and tracked using a computerized telemetry system. The term "surgeon" includes anyone in the operating room who may use or manipulate the guide system. The active probe may be tracked by various techniques, including: optical tracking of a "star" or other marker mounted on a portion of the probe that is continuously visible during the procedure; direct monitoring of the position of the probe using radiation imaging (e.g., X-ray) or magnetic imaging; physically connecting the probe to a reference system frame to mechanically track the position of the probe; or other means or combinations of means known in the art. The terms "navigation" and "guidance" are used interchangeably herein. Embodiments may also be used with a manual system, in which the surgeon moves the retractor system entirely by hand, or a semi-automatic or automatic system operated under the surgeon's control, or the retractor system is automatically advanced to the surgical site without the surgeon's intervention.

[0053] The embodiments can be used with a newly designed dedicated system or with a pre-existing system. For example, as will be appreciated by those skilled in the art, the embodiments can be used with a system such as the one described above by supplementing, modifying or replacing the introducer 102. Figure 1 The system shown in FIG. 1 may be used with the system shown in FIG. 1 , or with other introducer assemblies. The embodiments described in this application may be used with Figure 1 The present invention can be used with the retractor 100 shown, or with other retractors. It will be readily appreciated that the shape of the guide can be modified to fit any conventional retractor, and the guide can also be modified to connect to the retractor using any suitable clamp or other engagement mechanism if necessary or desired. For example, the embodiments can be used with a retractor such as Figure 1 The illustrated miniature version of the introducer is used with this embodiment, where this embodiment may optionally be scaled down to allow for visibility within the retractor, but such visibility need not be provided in all embodiments.

[0054] The exemplary embodiments described herein relate to guides for use in neurosurgery or other surgeries in and around the brain or skull. However, the guides may also be used in other parts of the body.

[0055] Figure 2A An exemplary embodiment of an introducer 200 is shown that is configured to be releasably retained within a retractor 202, such as Figure 1The introducer 200 includes a sidewall 204 extending from a proximal introducer end 206 to a distal introducer end 208. As used herein, "proximal" refers to the end that generally faces the surgeon during use, and "distal" refers to the end that faces toward or is inserted into the patient. When connected together, the proximal introducer end 206 can be located at or near the proximal retractor end and the distal introducer end 208 extends beyond the distal retractor end. The retractor 202 preferably includes a hollow tubular retractor passage that extends along a longitudinal axis from the proximal retractor end to the distal retractor end and is sized to allow surgery to be performed therethrough.

[0056] The introducer sidewall 204 forms an introducer passage 210 that extends along a longitudinal axis 212 extending from the proximal introducer end 206 to the distal introducer end 208. When assembled with the retractor 202, the distal end portion 214 of the introducer 200 extends beyond the distal end of the retractor 202. The distal end portion 214 and the retractor 202 together form a generally smooth and continuous surface for gently displacing brain tissue, etc. as the assembly is advanced into the body. The distal end portion 214 is preferably tapered, having a circular (e.g., as shown) or conical shape. The end opening 216 can be disposed at or near the distal introducer end 208, as discussed in more detail below. A locking member can be provided (see, e.g., Figure 1 ) to selectively retain the introducer 200 on the retractor 202.

[0057] The side wall 204 preferably comprises a continuous wall surface such that the passageway 210 has a closed outer perimeter, e.g. Figure 1 This can help prevent unwanted ingress of body fluids and provide a smooth, continuous surface for viewing through the side wall 204 (if it is transparent) and for guiding instruments along the length of the passage 210 without risk of displacement. However, in alternative embodiments, one or more openings 218 may be provided in the side wall 204.

[0058] The introducer sidewall 204 may have any suitable cross-sectional profile (i.e., a profile in a plane orthogonal to the longitudinal axis 212). For example, the sidewall 204 may be circular, elliptical, oval, or other generally curved shape (i.e., composed entirely of curved surfaces and / or very short straight surfaces that effectively simulate a smoothly curved shape). If desired, the cross-section may include one or more straight segments (e.g., D-shaped), or may be completely straight (e.g., square or triangular). The sidewall profile may also taper to be larger at the proximal end than at the distal end, and preferably at least slightly decreases in size as it approaches the distal introducer end 208. The outer surface of the sidewall 204 may be shaped to match the shape of the corresponding inner wall of the retractor 202, but this is not strictly required. The introducer sidewall 204 also preferably has a generally consistent wall thickness along its length, which may facilitate manufacturing and provide a more suitable optical path for viewing through the sidewall 204. It should be understood that the cross-sectional shape of the passage 210 will be defined by the shape of the sidewall 204 , and thus the above discussion regarding the shape of the sidewall 204 also applies to the shape of the passage 210 .

[0059] The introducer 200 is preferably transparent at least at the distal end 206, and more preferably transparent at the distal end portion 214, and more preferably transparent along most or the entire length of the sidewall 202. The transparent portion allows the surgeon to visualize the underlying tissue while advancing the introducer 200 through brain tissue, etc., which can provide significant benefits during surgery. However, in alternative embodiments, the introducer 200 can be opaque. Suitable materials for the introducer 200 include polycarbonate and other types of plastics, metals such as aluminum, stainless steel or titanium, glass or ceramics, or other materials that are biocompatible or can be treated to be biocompatible by coatings, etc.

[0060] The passageway 210 is sized to accommodate a navigation probe 220. The probe 220 includes a shaft 222 extending from a distal probe tip 224 to a proximal probe end 226. The probe 220 includes a navigation element 228 operatively associated with a navigation system to track the position of the probe 220 and communicate this information to the surgeon during surgery.

[0061] The navigation element 228 may include, for example, an optical array (e.g., three or more lights or reflectors in a predetermined physical pattern) that provide three-dimensional registration of the position of the probe end 224 when observed by a corresponding navigation camera system. Such an array may be mounted to the proximal probe end 226 or elsewhere where it may be observed by a navigation camera. The need for sight between the optical array and the camera may require that the navigation element 228 be positioned outside the guide 200. Alternatively, the navigation element 228 may include a magnetic element that can be tracked by a corresponding magnetic tracking system. In this case, it may not be necessary to position the navigation element 228 outside the guide 200. In view of the technical field to which the present disclosure belongs, other alternatives to the navigation element 228 will be apparent to those of ordinary skill in the art. Examples of navigation probes 220 and corresponding tracking systems are provided by StrykerNavigation of Kalamazoo, Michigan, USA, Brainlab AG of Feldkirchen, Germany, Synaptive Medical of Toronto, Ontario, and Medtronic of Minneapolis, Minnesota, USA.

[0062] The introducer passage 210 is significantly larger than the probe shaft 222 in the lateral direction (i.e., perpendicular to the longitudinal axis 212). This allows the surgeon to visualize the length of the passage 210 without unduly obstructing his or her line of sight. This can also allow the surgeon to insert other instruments such as an endoscope or an aspiration tube into the passage 210 while the probe 220 is continuously in place, etc. Due to their different relative sizes, the sidewall 204 cannot keep the navigation probe shaft 222 from moving laterally within the passage 210. It is expected that some lateral movement of the probe shaft 222 within the passage 210 will not seriously affect proper navigation, but it is believed that it is more important to ensure continuous and proper registration between the remote probe tip 224 and the fixed position at the distal introducer end 208. For example, maintaining the probe tip 224 with little or no deviation from the geometric center of the introducer profile at the distal introducer end 208 is expected to provide sufficient registration for accurate navigation, even if the proximal end of the shaft 222 may move laterally within the passage 210.

[0063] exist Figure 2A and Figure 2BIn the embodiment of the present invention, the probe tip 224 is maintained in registration with the distal guide end 208 by the probe receptacle 230. The probe receptacle 230 is preferably located at the geometric center of the guide profile of the distal guide end 208 (e.g., if the distal guide end 208 is elliptical, it is located at the geometric center of the ellipse), but this is not strictly required in all embodiments. For example, the receptacle 230 can be offset from the central axis of the guide.

[0064] In this embodiment, the probe socket 230 includes a substantially circular socket wall 232 having an inner surface 236 extending from a distal socket end 240 to a proximal socket end 234 within the passage 210. The inner surface 236 tapers from a relatively large diameter at the proximal socket end 234 to a relatively small diameter at the distal socket end 240. The distal socket end may be located at or near the distal introducer tip 208. The socket wall 232 is sized to limit lateral movement of the distal probe tip 224 beyond a predefined range of movement. For example, the socket wall 232 may limit movement of the probe tip 224 in a lateral direction to less than 1 millimeter ("mm"), or more preferably, the socket wall is sized to limit any movement in a lateral direction.

[0065] The diameter of the proximal socket end 234 can be of any size, but preferably not so large as to significantly obstruct the line of sight through the introducer 200, and not so small that it is difficult to position the probe tip 224 in the socket 230 during surgery. The tapered surface 236 of the socket wall helps to guide the probe tip 224 to the proper position in the socket 230, and the surface 236 can have a conical or curved profile when viewed from the lateral direction. The surface 236 can also have an area of ​​a specifically selected shape to match the shape of the probe tip 224. For example, if the probe tip 224 is hemispherical, all or a portion of the surface 236 can have a matching shape. As another example, if the probe tip 224 is cylindrical (or has a hemispherical end with a cylindrical body adjacent to the end), the distal portion of the surface 236 can have a matching cylindrical shape. In view of this disclosure, other alternatives will be apparent to those of ordinary skill in the art.

[0066] The shape and size of the socket wall 232 can also be designed to keep the probe tip 224 close to the distal guide end 208. For example, the distance from the distal guide end 208 to the probe tip measured along the longitudinal axis 212 is preferably less than 5.0mm, more preferably less than 1.0mm, and most preferably less than 0.5mm or less. In the case where the probe tip 224 is 1.0mm or less from the distal guide end 208, it may not be necessary to try to correct the displacement for the purpose of navigating into the brain tissue, because this is expected to be within the normal amount of deviation of the movement of the brain tissue in the skull. It is preferred (but not strictly required) that the probe tip 224 does not protrude beyond the distal guide end 208.

[0067] The introducer tip opening 216 (if provided) may be located within the probe receptacle 230 at the end of the receptacle wall 232, e.g. Figure 2B . Alternatively, the introducer tip opening 216 can be located elsewhere in the distal introducer end 208 (located outside the socket 230). The probe socket 230 can also include one or more openings forming a flow passage 238 to allow fluid to bypass the socket wall 232; this feature can help ensure that fluid that may accumulate at the distal end of the passage 210 is properly drained at a location between the proximal socket end 234 and the side wall 204. More specifically, a gap 242 can be provided between the outer wall 244 of the probe socket 230 and the introducer side wall 204, and in some cases fluid may accumulate in the gap 242. The flow passage 238 is configured to allow fluid to exit the gap 242.

[0068] In use, the surgeon assembles the introducer 200 and retractor 202 together, places the probe tip 224 into the receptacle 230, and uses the computer-assisted navigation provided by the probe 220 to guide the assembly to the surgical site. During navigation, the probe 220 indicates the position of the distal introducer end 208 relative to the underlying tissue via a computer screen that superimposes the probe image and tissue image. Throughout the procedure, the surgeon can preferably inspect the tissue through the transparent walls of the introducer 200 and retractor 202, and can periodically remove the probe 220 as needed to obtain better visualization or to perform intermediate procedures such as aspiration of fluids.

[0069] Figure 3A and Figure 3BAnother embodiment of an introducer 300 is shown. For simplicity, only the portion of the introducer 300 located near the distal introducer end 302 is shown in these illustrations, and it will be understood that other features of the introducer 300, such as the remainder of the internal passageway and other features previously described in this application will be connected to the shown portion. In this embodiment, the introducer 300 has a probe receptacle 304, which is suspended within the introducer 300 by a plurality of supports 306.

[0070] The probe socket 304 can be located on the centerline of the introducer, which is parallel to the longitudinal axis 308 of the introducer, but other locations are possible. The probe socket 304 preferably includes a socket wall 310 (which is circular, but can have other shapes) extending from a proximal socket end 312 to a distal socket end 314. The socket wall 310 has an inner surface 316 that tapers from a relatively large dimension at the proximal socket end 312 to a relatively small dimension at the distal socket end 314. The size and shape of the inner surface 316 are designed to retain the distal probe tip 224 to prevent lateral movement of the probe tip 224. For example, Figure 3B The probe tip 224 is shown in a position shortly before it is fully seated in the probe receptacle 304 to more clearly show the transition of the tapered inner surface 316 from the linearly tapered proximal surface portion 318 to the distal surface portion 320, which is shaped to match the hemispherical shape of the probe tip 224. When fully seated, the probe tip 224 abuts against the distal surface portion 320 in a ball-and-socket arrangement, with the hemispherical surface of the distal surface portion 320 cupped and tightly conforming to the hemispherical probe tip 224. In other embodiments, the inner surface 316 can have other shapes to accommodate probe tips 224 of different shapes and sizes. For example, a simple conical shape can accommodate different probes with various tip diameters.

[0071] The support members 306 are formed as planar ribs that radiate outward from the centerline of the introducer and extend parallel to the longitudinal axis 308. In alternative embodiments, the support members 306 may be replaced by other shapes, such as blocks, columns, and the like.

[0072] The probe receptacle 304 may be positioned proximate to an introducer tip opening 322 through the distal introducer end 302. The introducer tip opening 322 and the probe receptacle 304 are positioned so that fluid within the gap 328 between the probe receptacle outer wall 330 and the sidewall 204 may pass through the introducer tip opening 322 without passing through the probe receptacle 304. Thus, fluid may flow through the introducer tip opening 322 even when the probe tip 224 is installed in the probe receptacle 304. The probe receptacle 304 may also include a distal receptacle opening 324 through the distal receptacle end 314, which provides an additional flow path when the probe is not installed in the probe receptacle 304 and prevents fluid from pooling in the probe receptacle 304.

[0073] In the illustrated embodiment, the distal hub end 314 extends into the introducer tip opening 322 such that it is located at or near the plane of the distal introducer end 302. Thus, the introducer tip opening 322 is formed as an annular passage around the stylet hub 304, and the support 306 bridges the gap between the distal introducer end 302 and the stylet hub 304. The support 306 may include an arcuate void 326 to help reduce any disturbances that the support 306 may cause to the flow through the introducer tip opening 322.

[0074] The placement of the distal socket end 314 in the introducer end opening 322 can make the probe end 224 as close as possible to the distal introducer end 302. This simplifies the registration between probe 220 and the introducer 300, because there is almost no offset between their distal ends. However, it is not required to be this layout in all embodiments. For example, the probe socket 304 can further move (that is, return to the introducer passage) in the proximal direction to allow the fluid flow capacity through the introducer end opening 322 to be larger, and to make the introducer end opening 322 smaller for other reasons. If the offset between the probe end 224 and the distal introducer end 302 is significant, the computer system associated with probe 220 can be programmed to account for this offset when indicating the position of the introducer 300 for the surgeon, as known in the art.

[0075] The socket 304 is preferably positioned and sized so that at least a portion of the introducer sidewall 204 at the distal introducer end 302 is visible to the surgeon when the probe tip 224 is mounted in the socket 304. For example, a pair of transparent surfaces 332 of the sidewall 204 (which may be flat or curved as shown) around the socket 304 and the probe 220 may be visible. Even when the probe 220 is in place, the surgeon may visually inspect the underlying tissue and may move the probe shaft 222 around the passageway 210 to change its field of view without displacing the probe tip 224 from the socket 304.

[0076] Figure 4A and Figure 4B Another embodiment of an introducer 400 is shown. Figure 3A and Figure 3B 402. Similarly, only the area of ​​the introducer 400 adjacent to the distal introducer end 402 is shown. It should be understood that other features of the introducer 400, such as the remainder of the internal passageway and other features previously described in this application, will be connected to the shown portion. In this embodiment, the introducer 400 has a probe receptacle 404, which includes a portion suspended within the introducer 400 by a plurality of supports 406. The probe receptacle 404 can be located on the centerline of the introducer, which is parallel to the longitudinal axis 408 of the introducer, but other locations are possible.

[0077] The probe receptacle 404 preferably includes a receptacle wall 410 (which is circular, but may have other shapes) extending from a proximal receptacle end 412 to a distal receptacle end 414. The receptacle wall 410 has an inner surface 416 that tapers from a relatively large dimension at the proximal receptacle end 412 to a relatively small dimension at the distal receptacle end 414. The size and shape of the inner surface 416 are designed to retain the distal probe tip 224 to prevent lateral movement of the probe tip 224 when the probe tip 224 is fully seated in the probe receptacle 404. The inner surface 416 may be similar in construction to that described with respect to Figure 3A and Figure 3B The probe receptacle 304 described above may have other shapes configured to retain the probe tip 224. For example, the inner surface 416 may include a proximal portion adjacent to the proximal receptacle end 412, the proximal portion having a first angle θ in the range of 20° to 30° (e.g., 25°) relative to the longitudinal axis 408. 1 Relative to the upper portion of the distally positioned intermediate portion, the intermediate portion having a second angle θ relative to the longitudinal axis 408 in the range of 5 ° ~ 15 ° (eg, 10 °) 2 and a distal portion located distally relative to the middle portion, the distal portion being hemispherical or semi-hemispherical in shape, having a radius r in the range of 0.3 mm to 0.8 mm. This arrangement is desirable in order to provide easy and repeatable installation of the probe tip 224 into the socket 404 and to provide a unique feel when the probe tip 224 is fully seated.

[0078] The probe receptacle 404 is positioned adjacent to the introducer tip opening 418 through the distal introducer end 402. The introducer tip opening 418 and the probe receptacle 404 are positioned so that fluid can pass through the introducer tip opening 418 without passing through the proximal receptacle end 412. This allows fluid in the gap 426 between the outer wall 428 of the probe receptacle and the introducer side wall 204 to flow through the introducer tip opening 418 when the probe tip 224 is installed in the probe receptacle 404. In the illustrated embodiment, the outer wall 428 is shown as being spaced apart from the side wall 204 around its entire perimeter, but it should be understood that the outer wall 428 can merge with the side wall 204 at some locations (e.g., when the introducer profile is a narrow ellipse or oval, and the receptacle 404 has a circular profile).

[0079] The probe socket 404 may also include a distal socket opening 420 through the distal socket end 414 to provide an additional flow path when the probe is not installed in the probe socket 404 and to prevent fluid from pooling in the probe socket 404. The distal socket end 414 may extend into the introducer tip opening 418 so that it is located at or near the plane of the distal introducer end 402. In this case, the introducer tip opening 418 can be formed as an annular passage that surrounds the probe socket 404 and has supports 406 that bridge the gap between the distal introducer end 402 and the probe socket 404. The supports 406 may include arched gaps to help reduce any disturbances in the flow through the introducer tip opening 418 that may be caused by the supports 406. Figure 3A and Figure 3B As in the embodiment of the present invention, positioning the distal hub end 414 within the introducer tip opening 418 allows the stylet tip 224 to be placed as close to the distal introducer tip 402 as possible. However, this arrangement is not required in all embodiments.

[0080] In this embodiment, the proximal socket end 412 is larger in the transverse direction (i.e., perpendicular to the longitudinal axis 408) than the introducer tip opening 418. This provides a relatively large stylet socket 404 to help guide the stylet 220 to a suitable location, while keeping the size of the introducer tip opening 418 relatively small to help prevent the possibility of brain tissue or other delicate tissue being damaged by forced entry or shearing by the edges of the introducer tip opening 418. Figure 4B It is shown how this configuration helps guide the probe tip 224 into the probe receptacle 404 even when the probe tip 224 starts at a location that is significantly offset from the centerline of the probe receptacle (which, in this example, is co-linear with the geometric center of the introducer 400).

[0081] In the case where the proximal hub end 412 is larger than the introducer tip opening 418, it is particularly advantageous to provide additional provisions for ensuring proper flow through the introducer tip opening 418. To this end, the probe hub 404 may include one or more (preferably three) openings at a location between the proximal hub end 412 and the distal hub end 414 to allow fluid to flow to the introducer tip opening 418 without passing through the proximal hub end 412. These openings may be, for example, notches 422 extending inwardly from the outer surface of the probe hub 404 to the introducer tip opening 418. These notches 422 allow fluid to drain from the distal-most portion of the introducer passage to prevent pooling around the outer periphery of the probe hub 404 at the distal end of the introducer. The notches 422 in the illustrated embodiment extend in the longitudinal direction from the proximal hub end 412 to a portion of the sidewall 204 located adjacent the distal hub end 414, but other embodiments may have notches having different lengths in the longitudinal direction.

[0082] Each notch 422 may terminate at its inner end at an annular passage 424 that covers the introducer tip opening 418. The annular passage 424 passes through the inner surface 416 of the hub 424 and extends to the introducer tip opening 418, and is expected to help redistribute the fluid passing through the introducer tip opening 418 into a more uniform and less restricted flow. The support 406 bridges and interrupts the annular passage 424 to join the proximal hub end 412 to the distal hub end 414 and allow the distal hub end 414 to hang free at the introducer tip opening 418. The dimensions of the notch 422 and the annular passage 424 are designed to prevent the probe tip 224 from entering the notch and the annular passage (e.g., if the smallest probe tip 224 used is 0.8 mm or larger, then the notch and the annular passage have a maximum width of 0.5 mm).

[0083] As with the other embodiments, the socket 404 is preferably positioned and sized so that, when the probe tip 224 is installed in the socket 404, a transparent portion of the introducer sidewall 204 at the distal introducer end 402 is visible to the surgeon to allow visualization of the underlying tissue when the probe 220 is in place.

[0084] FIG. 5A to FIG. 5DAnother embodiment of an introducer 500 is shown in which only the area of ​​the introducer 500 adjacent to the distal introducer end 502 is shown. As with the previous embodiments, it should be understood that other features of the introducer 500 will be connected to the portion shown. In this embodiment, the introducer 500 has a probe socket 504 having a main support member 506 that joins a proximal socket end 508 to a distal socket end 510. The distal socket end 510 is adjacent to (and preferably within) the introducer end opening 512. The proximal socket end 508 is larger than the guide end opening 512 in a direction perpendicular to the longitudinal axis 514 of the introducer 500. The structure of the probe socket 504 is similar to that of the probe socket 504. Figure 4A and Figure 4B and may include the same variations and features (e.g., distal socket opening, etc.). Figure 4A and Figure 4B The description also applies to Figure 5A-5D Embodiment of the invention.

[0085] Figure 5A-5D Examples and Figure 4A and Figure 4B The primary support 506 differs from the primary support 506 in that secondary supports 516 are disposed on either side of each notch 518, which join the proximal hub end 508 to the distal hub end 510. The secondary supports 516 preferably have a larger gap at their distal ends to provide a more continuous flow path adjacent to the introducer tip opening 512. For example, the primary support 506 may be connected to the distal hub end 510 by ribs 520, the lower ends of which are located within or near the introducer tip opening 512, while the secondary supports 516 are connected to the distal hub end 510 by ribs 522, which are spaced above the introducer tip opening 512, such as Figure 5C This arrangement provides additional structure to support the distal socket end 510 and prevent the surgeon from embedding the probe tip 224 in the notch 518 or in the gap between the proximal socket end 508 and the distal socket end 510, while still providing an annular passage 524 ( Figure 5B, which annular passage may be interrupted at some locations by the main support ribs 520) to allow relatively free flow therein. The openings 526 located between the secondary supports 516 and the primary supports 506 provide flow passages that extend through the inner surface of the probe receptacle 504 and along the longitudinal axis 514 to the introducer end opening 512 to allow vertical fluid flow at various locations. As with the previous embodiments, the fluid in the gap 528 between the outer wall 530 of the probe receptacle and the introducer sidewall 204 can flow through the introducer end opening 512 without having to pass through the proximal introducer end 508, which helps to reduce any flow restriction that may be caused by the probe end 224.

[0086] It is also contemplated that the primary support 506 could be constructed similarly to the secondary support 516 shown (i.e., having a high arcuate rib 522 joined to the distal socket end 510). Figure 5A-5D The lower ribs of the illustrated primary support 506 may help increase strength and prevent tissue from entering the introducer tip opening 512. Alternatively, the secondary support 516 may be structurally identical to the primary support 506 if added support is found desirable and restriction of flow through the introducer tip opening 512 is not unduly compromised. Other alternatives will be apparent to one of ordinary skill in the art in light of this disclosure.

[0087] The probe receptacle of any given embodiment may have any suitable shape to accommodate any desired navigation probe. The probe receptacle may be configured to accommodate one specific type of probe, or it may be configured to hold a number of different navigation probes. For example, as described above with reference to Figure 2A-Figure 5D The probe receptacle may be configured to interchangeably receive any one of four or more different probes, such as FIG. 6A to FIG. 6D As shown. The first probe 600 has a tip diameter D of 1.0 mm and a taper angle θ of about 6.0°. The second probe 602 has a tip diameter D of 0.8 mm and a taper angle θ of about 7.5°. The third probe 604 has a tip diameter D of 1.0 mm and a taper angle θ of about 18.0°. The fourth probe 606 has a tip diameter D of 1.0 mm and a cylindrical shaft 608 extending proximally from the tip and having a diameter of 1.0 mm. Each of these probes can be inserted to keep the probe tip from lateral movement with the tip of the probe placed at the distal end of the socket (within 1.0 mm, more preferably within 0.5 mm of the distal introducer end).

[0088] The socket may be formed so that it is not possible for the surgeon to "wedge" the probe tip into place, as this may cause difficulty in removing the probe. To this end, it is preferred that the taper angle of the inner wall of the socket does not exactly match the taper angle of any particular probe tip, in a manner that locks the two components together. It is also preferred that the material of the socket is relatively hard to prevent it from deforming so as to allow the probe tip to be embedded therein. Polycarbonate plastic is expected to be suitable for this purpose, but other materials may also be used. Of course, no matter how the socket is designed, the surgeon may exert very large forces on the probe to embed it into the socket, so it is understood that these preferences are based on normal use of the instrument rather than setting strict requirements for all embodiments in all situations.

[0089] Alternatively, the socket may be intentionally formed to tend to capture the probe tip in place. For example, the probe tip may include an enlarged end that snaps into a corresponding shape in the socket so that force is required to remove the probe, or the socket may include a thin, deformable rib that tends to grip the end of the probe. This may require more care when removing the probe, but has the added benefit of not requiring the surgeon to hold the probe in his hand at all times.

[0090] It is expected that the foregoing embodiments will aid surgeons in using an introducer and retractor system with a navigation system. It is expected that the surgeon will use the device by assembling the introducer and retractor together, placing the navigation probe in the introducer until the end of the probe reaches the end of the probe receptacle, and then advancing the three parts forward into the tissue as a unit. During this step, the surgeon can remove the probe to better observe the introducer or insert other instruments or devices into the introducer. If necessary, a clamp or other device can be provided to hold the probe in place to free the surgeon's hands for other tasks. Examples of clamps are disclosed in the incorporated references, but other mechanisms may be used. In view of the technical field to which the present disclosure belongs, other uses and methods will be apparent to those of ordinary skill in the art.

[0091] The introducer end opening can add significant benefits to the system, such as by allowing fluid venting to prevent excessive pressure buildup around the introducer, allowing fluid removal, and if the opening is large enough, allowing tissue adjacent to the opening to be cut or manually moved. After the assembly is placed at the surgical site, when the introducer is withdrawn from the retractor, the end opening can also allow air to vent toward the tissue, which can help prevent the introducer from creating suction that pulls on the tissue as the introducer is withdrawn. Other benefits will be apparent in light of the present disclosure and further use of the system.

[0092] While it is contemplated that the foregoing embodiments may be used "freehand" by simply placing the probe tip 224 into the probe receptacle, in some circumstances the surgeon may wish to lock the probe 220 in place within the introducer 200. This may be accomplished by using a retention mechanism, such as Figure 7A-Figure 8B An exemplary probe retainer 700 is shown in FIG.

[0093] The probe retainer 700 includes a receiver 702 that is attached to the introducer 200 by a pair of clamps 704. The receiver 702 includes a channel 706 that is sized to receive the probe 220. The channel 706 is preferably a closed passage having a diameter suitable for accommodating the probe 220, but in other embodiments, it may include a longitudinal notch or have a "C" or "U" shaped profile, etc. The channel 706 has a proximal channel end 708 facing the surgeon and a distal channel end 710 extending into the introducer 200. When the probe shaft 222 is located in the channel 706, the channel 706 constrains and can completely limit the movement of the probe shaft 222 in the lateral direction.

[0094] The receiver 702 can be configured to selectively lock the stylet 220 in place within the channel 706. For example, the proximal channel end 708 can have a threaded outer surface 712 that is configured to engage a corresponding locking nut 714, and one or more cutout segments 716 through the proximal channel end 708. The threaded outer surface 712 and the locking nut 714 are configured so that the locking nut 714 compresses the threaded outer surface 712 when being tightened onto the threaded outer surface 712, such as by providing one or two slight tapers or making the diameter of the threads of the locking nut slightly smaller than the threads on the outer threaded surface 712. The cutout segments 716 provide relief to allow the threaded surface 712 to move inwardly when the locking nut 714 is tightened. Therefore, when the locking nut 714 is tightened onto the threaded outer surface 712, the threaded outer surface 712 moves radially inwardly, and the inner surface 718 of the proximal channel end 708 clamps and secures the stylet 220 in place. The receiver 702 may also include one or more retention flanges 720 to prevent the locking nut 714 from being completely removed from the receiver 702 .

[0095] Other locking mechanisms may be used in other embodiments. For example, the locking nut 714 may be replaced by a band clamp, a set screw, or other devices. Examples of alternative locking members are provided in the incorporated references, and other options will be apparent to those of ordinary skill in the art in light of this disclosure.

[0096] In the illustrated embodiment, the receiver 702 may include a plurality of notches 722 (e.g., three notches) extending proximally from the distal channel end 710. The exemplary notches 722 extend longitudinally along the longitudinal axis 212 of the assembly, but other orientations (e.g., spiral) may be used. The inner surface of the channel 706 may also be gently tapered so that the diameter of the channel 706 decreases as it approaches the distal channel end 710. The final diameter of the channel 706 at the distal channel end 710 may be slightly smaller than the probe 220 of the maximum diameter expected to be used with the device, so that the probe 220 is slightly squeezed by the receiver 702 at the distal channel end 710. The notches 722 allow the channel 706 to bend outward at the distal channel end 710 to accommodate different sizes of the probe 220. It is expected that this feature provides a useful slight retention force and can help position the probe 220 in the center of the channel 706.

[0097] Receiver can also be configured to, when probe 220 is installed in introducer 200, distal probe end 224 is directed toward socket (such as, socket 230,304,404 or 504). The aforementioned conical and slotted layout is expected to achieve this by directing channel 706 toward the corresponding socket at the distal introducer end, but other embodiments can use other configurations to do the same thing. Preferably, channel 706 extends in the longitudinal direction so that it prevents probe 220 from forming a significant angle in channel 706 (that is, it prevents the formation of an angle that may hinder distal probe end 224 from entering the socket). For example, the inner diameter of channel 706 can be no more than 110% of the maximum probe diameter, and the length of channel can be at least 300% of the maximum probe diameter, more preferably at least 1000%.

[0098] Notwithstanding the above, in other embodiments, the channel 706 may include a simple ring or passage that is non-tapered and does not include a notch, or the taper and notch may be replaced by a flexible membrane or cantilever that helps center the probe within the channel 706. Other alternatives will be apparent to one of ordinary skill in the art in light of this disclosure.

[0099] The clamp 704 is attached to the receiver 702 and is configured to hold the receiver 702 in a fixed position relative to the guide 200. The receiver 702 can be centered on the guide 200, as shown, or it can be offset from the centerline of the guide. In this embodiment, the clamp 704 is connected to the receiver 702 by a clamp arm 724, which is shaped to generally match the shape of the guide sidewall 204 at the proximal guide end 206. Therefore, each clamp arm 724 has an opening 726 through which the surgeon can observe the guide passage 210.

[0100] Each clamp 704 includes a tab 728 shaped to receive a user's finger and a hook 730 shaped to wrap around a corresponding flange 800 ( Figure 8A-B ) around. The clamp arm 724 is located between the wing 728 and the hook 730. The clamp arm 724 and the hook 730 can move between a locked position and an unlocked position, in which the hooks 730 are relatively close to each other, and in the unlocked position, the hooks 730 are relatively far away from each other. In their locked positions, the hooks 730 are spaced a first distance apart, at which they wrap around the corresponding flanges 800 to fix the probe retainer 700 to the introducer 200. When not attached to the introducer 200, the hook spacing in the locked position can be slightly larger than its natural resting position. Therefore, when attached to the introducer 200, the clamp arm 724 can be under a slight bending force, which is caused by the hook 730 bending from its resting position to its locked position. This can help provide a stronger locked connection and can reduce the possibility of displacement or movement during connection.

[0101] When the surgeon clamps the tabs 728 together, the clamp arms 724 bend and provide a fulcrum about which the hooks 730 rotate until they are a second distance from each other. In this position, the hooks 730 release the flanges 800 and the probe retainer 70 can be removed from the introducer. By reversing this operation, the clamp 704 can be reinstalled on the introducer 200, and the hooks 730 can include inclined surfaces to allow them to snap onto the flanges 800 simply by pressing the probe retainer 700 against the proximal introducer end 206.

[0102] In the exemplary embodiment, there are two clamp arms 724, each having two spaced apart portions around an opening 726 to allow for visualization into the introducer 200. Each clamp arm 724 is connected to the receiver 702 at two locations on opposite sides of the receiver 702. The attachment between the receiver 702 and the clamp arm 724 may have a support wall 732 to increase the rigidity of the connection. This is expected to help the clamp arm 724 bend in a more predictable manner during the removal and installation steps.

[0103] The foregoing clamp 704 layout is expected to provide a simple and reliable engagement to selectively connect the probe retainer 700 to the guide 200. However, other embodiments may use different structures to hold the probe in place. For example, the flexible clamp arm 724 can be replaced by a more rigid member having a mechanical pivot, such as a pivot pin, etc., and a return spring to bias the hook 730 to the clamped position. As another example, each clamp arm 724 can have a single portion located on one side of the guide 200, rather than two spaced-apart portions, and the clamp 704 can be rotated 90° relative to the position shown so that the guide 200 is clamped from the side rather than from the top. In view of this disclosure, other alternatives will be apparent to those of ordinary skill in the art.

[0104] Fig. 8A and Figure 8B shows what occurs when installed on an exemplary introducer 200. Figure 7A-7B The introducer 200 is shown assembled with a corresponding retractor 202. The introducer 200 preferably includes a probe tip receptacle, such as those previously described in this application, but it is also contemplated that the probe retainer 700 can be used with an introducer that does not have a probe tip receptacle, such as those described in reference to FIG. Figure 1 The assembly of stylet retainer 700 and navigation stylet 220 preferably can be removed from or installed into introducer 200 without separating introducer 200 from retractor 202. This allows quick access to the interior of the introducer if desired.

[0105] Fig. 9A and Fig. 9B Another embodiment of a probe retainer 900 is shown. In this case, the probe retainer includes a receiver 902 that can be attached to the introducer by a pair of clamps 904. This embodiment is generally similar to that shown in FIGS. Figure 8BThe embodiment shown is the same. However, in this embodiment, the mechanism for locking the probe shaft in place is different. The receiver channel 906 is formed with a threaded proximal end 908, a conically tapered central portion 910, and a relatively narrow distal portion 912. The locking nut 914 includes a proximal knob portion 916 suitable for use by a surgeon (e.g., knurled, or otherwise shaped to be engaged by fingers or tools), a male threaded central portion 918, and a tapered conical distal end 920 having one or more longitudinal notches 922. The central passage 924 passes through the locking nut 914 to receive the probe shaft. The threads 918 of the locking nut 914 are configured to be screwed into the threads 908 of the receiver 902, and the size of the conical distal end 920 of the locking nut 914 is adapted to the conical central portion 910 of the receiver 902. The locking nut 914 is pushed into the receiver 902 by rotating it relative to the receiver 902. When the tapered end 920 of the locking nut 914 engages the tapered center portion 916 of the receiver passage 906, the contact between the components causes the tapered end 920 to bend radially inward to press against the probe shaft. Thus, the locking nut 914 can cooperate with the receiver 902 to engage and hold the probe shaft in a fixed position.

[0106] The locking nut 914 can be retained by one or more features that interlock with the receiver 902. For example, the receiver 902 can have one or more hooks 926 that surround a flange 928 that extends radially from the knob portion 916 of the locking nut 914. These retaining features prevent the locking nut 914 from accidentally separating from the receiver 902 when the locking nut 914 is fully loosened. However, in some embodiments, the hooks 926 can be designed to be deformable to allow the locking nut 914 to be removed. In view of this disclosure, other alternatives and variations will be apparent to those of ordinary skill in the art.

[0107] It should be understood that the foregoing embodiments may be modified in various ways. As an example, features disclosed in one embodiment may be used with any other embodiment. As another example, the probe socket described in the present application may be formed integrally with the introducer by additive manufacturing or molding (the illustrated embodiments show various configurations in which a conventional two-part injection molding process may be used to make the introducer and probe socket into a single, integrally molded component), or formed separately and attached to the introducer. As another example, the probe socket may have any sidewall profile shape, rather than the generally circular shape shown in the embodiments. The probe socket may also have any combination of conical, cylindrical, hemispherical, or other shapes. It is also contemplated that the probe socket may have an opening even when the introducer does not have a guide end opening, for example Figure 2BThe flow passage and the notch of the latter embodiment can facilitate the displacement of fluid from the socket to allow free access to the probe tip. In view of the technical field to which this disclosure belongs, other alternatives will be obvious to those of ordinary skill in the art.

[0108] The present disclosure describes many new, useful and non-obvious features and / or combinations that can be used alone or together. The embodiments described in this application are all exemplary and are not intended to limit the scope of the invention. It should be understood that the invention described in this application can be modified and adjusted in various and equivalent ways, and all these modifications and adjustments are intended to be included in the scope of this disclosure and the appended claims.

Claims

1. An introducer system for use with a navigation probe, the navigation probe having a navigation element and a navigation probe shaft, the navigation probe shaft having a diameter and terminating at a distal probe tip, the introducer system include: An introducer, the introducer having: a side wall extending along the longitudinal axis and forming an introducer passage extending from the proximal introducer end to the distal introducer end, the side wall being larger than a diameter of the navigation probe shaft in a transverse direction orthogonal to the longitudinal axis, and a probe receptacle at the distal introducer end, the probe receptacle extending along the longitudinal axis within the introducer passage from a proximal receptacle end to a distal receptacle end, the probe receptacle having an inner surface having a first transverse dimension along the transverse direction at the proximal receptacle end and a second transverse dimension along the transverse direction at the distal receptacle end, the first transverse dimension being greater than the second transverse dimension; as well as a stylet retainer configured to be selectively coupled to the proximal introducer end, the stylet retainer comprising a receiver configured to receive the navigation stylet shaft and limit movement of the navigation stylet shaft in the lateral direction, wherein the stylet retainer comprises one or more clamps connected to the receiver and configured to selectively connect to the proximal introducer end, and Wherein, each of the one or more clamps is connected to the receiver by a clamp arm having an arm opening therethrough, each arm opening being aligned with the introducer passage to provide a visual path into the introducer passage.

2. The introducer system according to claim 1, in, The one or more clamps include two clamps.

3. The introducer system according to claim 1, in, The receiver includes a lock for selectively retaining the navigation probe shaft.

4. An introducer system for use with a navigation probe, the navigation probe having a navigation element and a navigation probe shaft, the navigation probe shaft having a diameter and terminating at a distal probe tip, the introducer system include: an introducer having a sidewall extending along a longitudinal axis and forming an introducer passage extending from a proximal introducer end to a distal introducer end, the introducer passage being larger than a diameter of the navigation probe shaft in a transverse direction orthogonal to the longitudinal axis; as well as a stylet retainer configured to be selectively coupled to the proximal introducer end, the stylet retainer comprising: a receiver configured to receive the navigation probe shaft and limit movement of the navigation probe shaft in the lateral direction, a first clamp and a second clamp connected to the receiver, the receiver being located between the first clamp and the second clamp, each of the first clamp and the second clamp being selectively engageable with a corresponding portion of the side wall to hold the receiver in a fixed position relative to the guide, Wherein the receiver, the first clamp and the second clamp are configured to provide a visualization path through the stylet retainer and into the introducer passage.

5. The introducer system according to claim 4, in, Each of the first and second clamps is connected to the receiver by a respective clamp arm, each clamp arm having an opening therethrough that aligns with the introducer passage to form a portion of a respective visualization path through the stylet retainer.

6. The introducer system according to claim 4, in, Each of the first clamp and the second clamp is connected to the receiver by a corresponding clamp arm and includes a tab extending from the clamp arm in a first direction and a hook extending from the clamp arm in a second direction, the second direction being substantially opposite to the first direction.

7. The introducer system according to claim 6, in, The first clamp and the second clamp are connected to the receiver by respective flexible connectors, each of which is movable to allow the respective tab to move toward the receiver and to allow the respective hook to move away from the receiver, thereby releasing the respective hook from engagement with the side wall.

8. The introducer system according to claim 7, in, The flexible connector includes a bendable clamp arm.

9. The introducer system according to claim 6, in, The side wall includes one or more outwardly extending flanges at the proximal guide end, and the one or more outwardly extending flanges have: a first portion positioned to engage with the corresponding hook of the first clamp; and a second portion positioned to engage with the corresponding hook of the second clamp.

10. The introducer system according to claim 4, in, The receiver includes a lock for selectively retaining the navigation probe shaft from movement along the longitudinal axis.

11. The introducer system according to claim 10, in, The locking member comprises: a first threaded member having an internal passage with a first tapered surface; and a second threaded member having an outer body having a second tapered surface that fits into the first tapered surface and an inner passage sized to receive the navigation probe shaft; Wherein, relative rotation between the first threaded member and the second threaded member causes the first tapered surface to move toward the second tapered surface to compress the internal channel to hold the navigation probe shaft.

12. The introducer system according to claim 11, in, The second tapered surface includes one or more notches extending along the longitudinal axis.

13. The introducer system according to claim 11, in, The first threaded member includes a hollow passageway connected to move with the first clamp and the second clamp, and the second threaded member includes a knob portion connected to the second tapered surface.

14. The introducer system according to claim 13, in, The probe retainer includes one or more hooks positioned to engage a flange on the second threaded member to prevent the second threaded member from separating from the first threaded member.

15. The introducer system according to claim 11, in, The second threaded member is connected to move together with the first clamp and the second clamp, and the first threaded member includes a knob portion connected to the first tapered surface.

16. The introducer system according to claim 13, in, The probe retainer includes one or more hooks positioned to engage a flange on the first threaded member to prevent the first threaded member from separating from the second threaded member.

17. The introducer system according to claim 4, in, The receiver includes a receiver passage extending along the longitudinal axis from a proximal receiver passage end located relatively close to the proximal guide end to a distal receiver passage end located relatively close to the distal guide end, and the receiver includes one or more notches along the longitudinal axis at the distal receiver passage end.

18. The introducer system according to claim 17, in, The inner diameter of the receiver passage tapers at the distal receiver passage end.

19. The introducer system according to claim 4, in, The introducer includes a probe socket at the distal introducer end, the probe socket extending from a proximal socket end to a distal socket end within the introducer passage along the longitudinal axis, the probe socket having an inner surface having a first transverse dimension along the transverse direction at the proximal socket end and a second transverse dimension along the transverse direction at the distal socket end, the first transverse dimension being greater than the second transverse dimension.

20. The introducer system according to claim 19, in, The probe receptacle includes a distal receptacle opening extending through the distal receptacle end and forming a first fluid flow path between the interior surface and an exterior of the sidewall at the distal introducer end.

21. The introducer system according to claim 19, in, At least a portion of the probe socket is spaced apart from the side wall by a gap in the lateral direction.

22. The introducer system according to claim 21, in, The probe receptacle includes at least one opening at a location between the receptacle proximal end and the receptacle distal end, the at least one opening forming a fluid communication path between the inner surface and the gap.

23. The introducer system according to claim 4, further comprising: include: The introducer tip is open, forming a fluid flow path through the side wall at the distal introducer end.

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