Patent Description:
A variety of different devices have been used to retract delicate tissue during surgical procedures. One such device is illustrated in <CIT>. <FIG> of this publication illustrates a soft tissue retractor system having a hollow retractor <NUM>, and an introducer <NUM> that is selectively inserted into the retractor <NUM>. The retractor <NUM> and/or introducer <NUM> may include a handle <NUM> to facilitate manipulation and placement of the retractor system, and a lock to hold the introducer and retractor together. The handle <NUM> is configured to connect to a clamp <NUM>, such as the standard surgical clamp <NUM> shown in <FIG>. The device in <FIG> (with some modifications) is commercially sold as the "VBAS" device by Vycor Medical, Inc. of Boca Raton, Florida.

A retractor system such as shown in <FIG> is often used by inserting the introducer <NUM> into the retractor <NUM> and locking it in place, so the two can be moved and manipulated as a unit. The combined retractor system is inserted into the patient's body and moved to the surgery site, and then the introducer <NUM> is unlocked and removed to permit access to the site through the retractor <NUM>. When the unit is in place (either before or after the introducer <NUM> is removed), the handle <NUM> may be locked to a clamp <NUM> to hold the retractor <NUM> in place. Surgeons using this retractor sometimes do not use a clamp to hold the retractor at the surgery site, and often manually manipulate the retractor to access different parts of the surgery site during the surgical procedure. The retractor system and the retractor may be manipulated by holding the proximal ends of the introducer or retractor or by holding the handle.

The device shown in <FIG> may have a transparent introducer <NUM> and/or retractor <NUM>, and surgeons using such devices advantageously use the transparent introducer and retractor to observe the underlying tissue and to visually guide the unit to the surgery site. While it has been found that visual guidance by looking through the introducer <NUM> is very beneficial, it also has been found that some form of additional guidance or navigation may be desired in some cases. For example, in some cases, surgeons have used a probe or guide wire (a narrow elongated rod) to guide the movement of the retractor system. In such cases, the probe is advanced to the surgery site, and then the interlocked retractor system is slid over the probe until it reaches the surgery site. This is facilitated by the inclusion of a hole at the tip of the introducer that fits around the probe. If the hole through the tip of the introducer is absent, this method cannot be used. This type of system is described in <CIT> and <CIT>. These references also show an alternative construction, in which the retractor is not locked to the introducer.

It has been found that some surgeons using the above procedure may use a probe that is integrated into a computer navigation system. For example, the probe may include a so-called "starburst" or the like, on the probe's proximal end (i.e., the end opposite the distal end that is inserted to the surgical site). This and other navigation systems are known in the art. For example, frameless navigation systems and other computerized guidance systems and methods are described in <CIT> and others, and are commercially available from companies such as Medtronic, Inc. , Stryker, BrainLab, AG, and GE Healthcare. As used herein, "computerized guidance" encompasses any method of guiding a device to or at a surgical site that relies on computer visualization and/or control.

<CIT> briefly notes the possibility of using stereotactic guidance or navigation in conjunction with a surgical retractor, but does not illustrate or describe this procedure or any apparatus for accomplishing this objective. Nevertheless, surgeons have been known to use a navigation probe "freehand" with a VBAS device such as shown in <FIG>. In such cases, the surgeon holds the navigation probe in place within the introducer while advancing the unit towards the surgery site. The tip of the probe may be placed in or near an opening through the tip of the introducer, but the opening through the introducer may be somewhat larger than the probe tip and is oval, and does not hold the probe tip in any particular orientation. Such techniques can suffer from inaccuracy and displacement of the probe from the introducer tip, and it can be difficult to hold the probe in place. Also, in some cases the probe tip may extend partially through the introducer tip opening, which can risk damaging underlying tissue. However, freehand use can be helpful to allow occasional removal of the probe to provide an unobstructed view through the introducer of the underlying tissue.

While computerized surgical guidance systems are well-known, a number of limitations exist with respect to their use with retractor systems, and particularly with systems like those shown in <FIG>. For example, while some surgeons use computerized guidance to direct a probe to the surgery site, and then slide the retractor system over the probe to the site, the movement of the retractor may be somewhat imprecise and the process can be unduly cumbersome. This method also is not available if the retractor system does not have a through-hole that fits over the probe (due either to the absence of a hole or a hole that is too small). In addition, the probe does not provide a view of the tissue through which it is advanced, so there is no visual means to perceive and avoid critical tissue (e.g., major blood vessels or nerves) when inserting a probe before inserting a retractor/introducer system. Also, the small-diameter probe may sever delicate tissue cells, such as grey or white brain matter, rather than moving the cells aside and passing between them as would be expected to happen when advancing the retractor system.

<CIT> shows examples of systems for integrating a navigation probe into a surgical introducer. For example, <FIG> of this publication show a navigation probe that is secured to the inside of a pre-existing introducer by resilient means, such as rubber plugs or O-rings. Another embodiment uses a slip fit (e.g., <FIG>), and still another embodiment uses an arm to hold the probe down inside the introducer (<FIG>). Still other versions mount the navigation device outside the introducer, to an arm that is connected to the retractor assembly (Figs. <NUM>-<NUM>). While these systems may provide suitable performance, they also have certain potential shortcomings. For example, resilient plugs may slip in the presence of fluids and may be difficulty to disengaged to remove the navigation device during surgery, a slip fit requires careful monitoring to ensure proper positioning, an arm as shown in <FIG> to hold the probe in place requires the probe to be modified to include a surface against which the arm pushes, and locating the navigation device outside the introducer complicates the correlation between the navigation device and the tip of the introducer or retractor.

<CIT> shows another example of a system for integrating a navigation probe into a surgical introducer. In this case, the probe is retained in a narrow channel through the introducer, and held in place with a threaded locking screw. The locking screw adds an additional potentially-removable part to the operating theater, and therefore this reference adds a separate retaining device (see <FIG>) to prevent the locking screw from being removed. The locking screw also can be relatively difficult to manipulate, particularly when wearing surgical gloves.

<CIT> shows yet another example of a system for integrating a navigation probe into a surgical introducer. The device shown in this publication holds the probe in a tube-like sheath that extends distally into the introducer from the proximal open end of the introducer, and has a convenient single-throw clamp to lock the probe in place. This device also optionally includes a mechanism to indicate when the navigation probe is fully seated in the introducer. While this device is useful to ensure greater accuracy and registration between the introducer and the navigation probe, it may obstruct the surgeon's view to some degree, and may make frequent removal and reinstallation of the navigation probe somewhat cumbersome as compared to freehand use of the probe.

It has been found that there still remains a need to provide alternative apparatus and methods for coordinating the use of guidance systems with surgical introducers.

Claim <NUM> defines the invention and dependent claims disclose further embodiments. No surgical methods are claimed. In one exemplary aspect, there is provided an introducer system for use with a navigation probe having a navigation element and a navigation probe shaft having a diameter and terminating at a distal probe tip. The introducer system includes a sidewall extending along a longitudinal axis and forming an introducer passage extending from a proximal introducer end to a distal introducer end, the sidewall being larger, in a lateral direction that is orthogonal to the longitudinal axis, than the navigation probe shaft diameter. The introducer also includes a probe receptacle located 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 lateral size in the lateral direction at the proximal receptacle end and a second lateral size in the lateral direction at the distal receptacle end, the first lateral size being greater than the second lateral size. The inner surface is configured and dimensioned to receive the distal probe tip and restrict movement of the distal probe tip in the lateral direction, and the sidewall is configured and dimensioned to allow the navigation probe shaft to move in the lateral direction within the passage when the distal probe tip is positioned in the probe receptacle.

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 the geometric center of the sidewall profile.

The inner surface may have a proximal portion adjacent the proximal receptacle end having a first angle relative to the longitudinal axis, and an intermediate portion located distally from the upper portion and having a second angle relative to the longitudinal axis, the second angle being less than the first angle. The first angle may be <NUM>°-<NUM>° and the second angle may be <NUM>°-<NUM>° degrees. The inner surface further may include a distal portion located distally from the intermediate portion forming at least a portion of a hemispherical surface.

The probe receptacle may have a distal receptacle opening passing through the distal receptacle end and forming a first fluid flow path between the inner surface and an exterior of the sidewall at the distal introducer end. The introducer also may include an introducer tip opening forming a second fluid flow path between the introducer passage and the exterior of the sidewall at the distal introducer end.

At least a portion of the probe receptacle may be spaced from the sidewall in the lateral direction by a gap. The probe receptacle may have at least one opening at a location between the receptacle proximal end and the receptacle distal end forming a fluid communication path between the inner surface and the gap.

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

The probe receptacle may overlie the introducer tip opening as viewed along the longitudinal axis and the introducer may further include at least one fluid flow path that extends through the introducer tip opening without passing through the proximal receptacle end. The introducer may have one or more supports extending between the sidewall and the probe receptacle to suspend the probe receptacle adjacent the introducer tip opening. The one or more supports may be a plurality of ribs extending along the longitudinal axis. The distal receptacle end may be located within the introducer tip opening. At least part of the one or more supports may be located within the introducer tip opening. The probe receptacle may be smaller or larger in the lateral direction than the introducer tip opening.

The inner surface may be configured to hold the distal probe tip adjacent the distal introducer end. The inner surface may be configured to hold the distal probe tip within <NUM>, or within <NUM>, of the distal introducer end. The inner surface may be configured to hold at least four different navigation probes, each navigation probe having a distal probe tip having a geometric shape that is distinct from the other navigation probes, with each of the distal probe tips located, when fully installed in the probe receptacle, within <NUM>, or within <NUM>, of the distal introducer end.

At least a portion of the sidewall at the distal introducer end may be transparent and visible from the proximal introducer end when the navigation probe is installed within the introducer.

The introducer system may also include a probe retainer configured to selectively connect to the proximal introducer end. The probe retainer has a receiver configured to receive the navigation probe shaft when the probe retainer is attached to the proximal introducer end and thereby limit movement of the navigation probe shaft in the lateral direction.

In another exemplary embodiment, there is provided an introducer system for use with a navigation probe having a navigation element and a navigation probe shaft having a diameter and terminating at a distal probe tip. The introducer system has 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 sidewall being larger, in a lateral direction that is orthogonal to the longitudinal axis, than the navigation probe shaft diameter, and a probe receptacle located 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 lateral size in the lateral direction at the proximal receptacle end and a second lateral size in the lateral direction at the distal receptacle end, the first lateral size being greater than the second lateral size. The introducer system also includes a probe retainer configured to selectively connect to the proximal introducer end. The probe retainer includes a receiver configured to receive the navigation probe shaft and limit movement of the navigation probe shaft in the lateral direction.

The probe retainer may have one or more clamps connected to the receiver and configured to selectively connect to the proximal introducer end. The one or more clamps may be two clamps, each clamp being connected to the receiver by a clamp arm having an arm opening therethrough, and each arm opening being aligned with the introducer passage to provide a visual path into the introducer passage. The receiver may have a lock to selectively hold the navigation probe shaft.

In another exemplary aspect, there is provided an introducer system for use with a navigation probe having a navigation element and a navigation probe shaft having a diameter and terminating at a distal probe tip. The introducer system includes an introducer and a probe retainer. The introducer has 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, in a lateral direction that is orthogonal to the longitudinal axis, than the navigation probe shaft diameter. The probe retainer is configured to selectively connect to the proximal introducer end. The probe retainer includes a receiver configured to receive the navigation probe shaft and limit movement of the navigation probe shaft in the lateral direction, and a first clamp and a second clamp, the first clamp and the second clamp being connected to the receiver with the receiver located between the first clamp and the second clamp, each of the first clamp and the second clamp being selectively engageable with respective portions of the sidewall to hold the receiver at a fixed location relative to the introducer. The receiver, the first clamp, and the second clamp are configured to provide a visual path through the probe retainer and into the introducer passage.

Each of the first clamp and the second clamp may be connected to the receiver by a respective clamp arm, each clamp arm having an opening therethrough, the opening being aligned with the introducer passage to form a respective part of the visual path through the probe retainer.

Each of the first clamp and the second clamp may be connected to the receiver by a respective clamp arm, and may comprise 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 generally opposite the first direction. The first clamp and the second clamp may be connected to the receiver by respective flexible connections, each flexible connection being movable to allow the respective tab to move towards the receiver and the respective hook to move away from the receiver to thereby release the respective hook from engagement with the sidewall. The flexible connections may be bendable clamp arms. The sidewall may have one or more outwardly-extending lips at the proximal introducer end, the one or more outwardly-extending lips having a first portion positioned to be engaged with the respective hook of the first clamp, and a second portion positioned to be engaged with the respective hook of the second clamp.

The receiver may have a lock to selectively hold the navigation probe shaft against movement along the longitudinal axis. The lock may have a first threaded member having an inner passage with a first tapered surface; and a second threaded member having an outer body having a second tapered surface that fits within the first tapered surface and an inner channel dimensioned to receive the navigation probe shaft; wherein relative rotation between the first threaded member and the second threaded member moves the first tapered surface towards the second tapered surface to compress the inner channel to hold the navigation probe shaft. The second tapered surface may have one or more slots extending along the longitudinal direction.

The first threaded member may have a hollow passage connected to move with the first clamp and the second clamp, 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 lip on the second threaded member to inhibit the second threaded member from separating from the first threaded member.

The second threaded member may be connected to move with the first clamp and the second clamp, 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 lip on the first threaded member to inhibit the first threaded member from separating from the second threaded member.

The receiver may have a receiver passage extending along the longitudinal axis from a proximal receiver passage end located in relative proximity to the proximal introducer end, to a distal receiver passage end located in relative proximity to the distal introducer end, and the receiver comprises one or more slots along the longitudinal axis at the distal receiver passage end. An inner diameter of the receiver passage may taper to a smaller size at the distal receiver passage end.

The introducer may have a probe receptacle located 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 lateral size in the lateral direction at the proximal receptacle end and a second lateral size in the lateral direction at the distal receptacle end, the first lateral size being greater than the second lateral size. The probe receptacle may have a distal receptacle opening passing through the distal receptacle end and forming a first fluid flow path between the inner surface and an exterior of the sidewall at the distal introducer end. At least a portion of the probe receptacle may be spaced from the sidewall in the lateral direction by a gap. The probe receptacle may have at least one opening at a location between the receptacle proximal end and the receptacle distal end forming a fluid communication path between the inner surface and the gap.

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

The foregoing summary provides a variety of exemplary embodiments that may be used in any suitable combination, and is not intended to impose any limitations upon the invention which is defined by the claims.

A better understanding of the exemplary embodiments may be understood by reference to the attached drawings, in which like reference numbers designate like parts. The drawings are exemplary, and not intended to limit the claims in any way.

Embodiments may provide various features to supplement or advance the state of the art of surgical introducers and retractor systems. As used herein, the term "guidance system" is intended to include any system for assisting a surgeon with advancing the retractor system to the surgery site, and can include passive systems like guide wires, or active systems like navigation probes that are detected and tracked using a computerized telemetry system. The term "surgeon" includes anyone in the operation theater who might use or manipulate the introducer system. Active probes can be tracked by various techniques, including: optically tracking a "starburst" or other marker mounted on a portion of the probe that remains visible during the procedure; directly monitoring the probe's position using radiation imaging (e.g., X-ray) or magnetic imaging; physically connecting the probe to a frame of reference system to mechanically track the position of the probe; or other means or combinations of means, as known in the art. The terms "navigation" and "guidance" are used interchangeably herein. Embodiments also may be used with manual systems in which the surgeon moves the retractor system entirely by hand, or semi-automated or automated systems that operate under the surgeon's control or automatically advance the retractor system to the surgery site without the surgeon's intervention.

Embodiments may be used with dedicated systems that are designed anew, or with preexisting systems. For example, embodiments may be used with systems like the one shown in <FIG>, such as by supplementing, modifying or replacing the introducer <NUM>, or with other introducer assemblies, as will be appreciated by persons or ordinary skill in the art. The embodiments described herein may be used with a retractor <NUM> as shown in <FIG>, or in other retractors. It will be readily appreciated that the shape of the introducer can be modified to fit into any conventional retractor, and the introducer also may be modified to connect to the retractor (if necessary or desired) using any suitable clamp or other engagement mechanism. For example, embodiments may be used with small-scale versions of introducers like the one shown in <FIG>, in which the embodiment optionally may be scaled down to allow visibility into the retractor, but providing such visibility is not required in all embodiments.

The exemplary embodiments described herein are directed towards introducers for use in neurosurgery or other operations in and around the brain or skull. However, uses in other parts of the body are also possible.

<FIG> shows an exemplary embodiment of an introducer <NUM> that is configured to be releasably retained inside a retractor <NUM> such as retractor <NUM> of <FIG>. The introducer <NUM> comprises a sidewall <NUM> that extends from a proximal introducer end <NUM> to a distal introducer end <NUM>. As used herein, "proximal" refers to the end that generally faces the surgeon in use, and "distal" refers to the end that is located towards or inserted into the patient. When connected together, the proximal introducer end <NUM> may be located at or near a proximal retractor end, and the distal introducer end <NUM> extends beyond a distal retractor end. The retractor <NUM> preferably comprises a hollow tubular retractor passage extending along a longitudinal axis from a proximal retractor end to a distal retractor end, and is dimensioned to allow surgical procedures to be undertaken therethrough.

The introducer sidewall <NUM> forms an introducer passage <NUM> that extends along a longitudinal axis <NUM> extending from the proximal introducer end <NUM> to the distal introducer end <NUM>. When assembled with the retractor <NUM>, a distal tip portion <NUM> of the introducer <NUM> extends beyond the distal end of the retractor <NUM>. Together, the distal tip portion <NUM> and the retractor <NUM> form a generally smooth and continuous surface for gently displacing brain tissue or the like as the assembly is advanced into the body. The distal tip portion <NUM> preferably is tapered with a rounded (such as shown) or conical shape. A tip opening <NUM> may be provided at or near the distal introducer end <NUM>, as discussed in more detail below. A lock (see, e.g., <FIG>) may be provided to selectively hold the introducer <NUM> to the retractor <NUM>.

The sidewall <NUM> preferably comprises a continuous wall surface such that the passage <NUM> has a closed outer perimeter, such as shown in <FIG>. This can help prevent unwanted entry of body fluids and provide a smooth continuous surface for viewing through the sidewall <NUM> (if it is transparent) and for guiding instruments down the length of the passage <NUM> without risk of displacement. However, one or more openings <NUM> may be provided in the sidewall <NUM> in alternative embodiments.

The introducer sidewall <NUM> may have any suitable cross-sectional profile (i.e., profile in a plane orthogonal to the longitudinal axis <NUM>). For example, the sidewall <NUM> may be circular, elliptical, oval or otherwise generally curved (i.e., comprised 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 rectilinear segments (e.g., a D-shape), or may be entirely rectilinear (e.g., a square or triangular shape). The sidewall profile also may taper to be larger at the proximal end than at the distal end, and preferably reduces at least slightly in size as it approaches the distal introducer end <NUM>. The outer surface of the sidewall <NUM> may be shaped to match the shape of a corresponding inner wall of the retractor <NUM>, but this is not strictly required. The introducer sidewall <NUM> also preferably has a generally consistent wall thickness along its length, which can facilitate manufacturing and provide a more suitable optical path for viewing through the sidewall <NUM>. It will be understood that cross-sectional shape of the passage <NUM> will be defined by the shape of the sidewall <NUM>, and therefore the foregoing discussion about the shapes of the sidewall <NUM> applies also the shape of the passage <NUM>.

The introducer <NUM> preferably is transparent at least at the distal end <NUM>, and more preferably at the distal tip portion <NUM>, and more preferably along most or the full length of the sidewall <NUM>. The transparent portion allows the surgeon to visualize underlying tissue while advancing the introducer <NUM> through brain tissue or the like, which can provide significant benefits during surgery. However, in alternative embodiments, the introducer <NUM> may be opaque. Suitable materials for the introducer <NUM> include polycarbonate and other kinds of plastic, metals such as aluminum, stainless steel or titanium, glass or ceramic, or other materials that are biocompatible or that can be treated via coatings or the like to be biocompatible.

The passage <NUM> is sized to accommodate a navigation probe <NUM>. The probe <NUM> comprises a shaft <NUM> that extends from a distal probe tip <NUM> to a proximal probe end <NUM>. The probe <NUM> includes a navigation element <NUM> that is operatively associated with a navigation system to track the position of the probe <NUM> and convey this information to the surgeon during the course of surgery.

The navigation element <NUM> may comprise, for example, an optical array (e.g. three or more lights or reflectors in a predetermined physical pattern) that provides a three-dimensional registration of the position of the probe tip <NUM> when viewed by a corresponding navigation camera system. Such an array may be mounted to the proximal probe end <NUM> or elsewhere where it can be viewed by the navigation cameras. The need for a line-of-sight between the optical array and the cameras is likely to require the navigation element <NUM> to be positioned outside the introducer <NUM>. Alternatively, the navigation element <NUM> may comprise 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 <NUM> outside the introducer <NUM>. Other alternatives of navigation elements <NUM> will be apparent to persons of ordinary skill in the art in view of the present disclosure. Examples of navigation probes <NUM> and corresponding tracking systems are provided by Stryker Navigation of Kalamazoo, Michigan, U. ; Brainlab AG of Feldkirchen, Germany; Synaptive Medical of Toronto, Ontario; and Medtronic of Minneapolis, Minnesota, U.

The introducer passage <NUM> is significantly larger in the lateral direction (i.e., perpendicular to the longitudinal axis <NUM>) than the probe shaft <NUM>. This may allow the surgeon to visualize down the length of the passage <NUM> without her vision being unduly obstructed by the probe <NUM>. This also may allow the surgeon to insert other instruments such as an endoscope or aspiration tube into the passage <NUM> while the probe <NUM> remains in place, and so on. As a consequence of their disparate relative sizes, the sidewall <NUM> does not hold the navigation probe shaft <NUM> against lateral movement within the passage <NUM>. It expected that some lateral movement of the probe shaft <NUM> within the passage <NUM> will not critically affect proper navigation, but it is believed to be more important to assure continuous proper registration between the distal probe tip <NUM> and a fixed location at the distal introducer end <NUM>. For example, maintaining the probe tip <NUM> with little or no deviation from the geometric center of the introducer profile at the distal introducer end <NUM> is expected to provide sufficient registration for accurate navigation, even if the proximal end of the shaft <NUM> might move laterally within the passage <NUM>.

In the embodiment of <FIG>, the probe tip <NUM> is maintained in registration with the distal introducer end <NUM> by a probe receptacle <NUM>. The probe receptacle <NUM> preferably is located at the geometric center of the introducer profile at the distal introducer end <NUM> (e.g., the geometric center of the ellipse if the distal introducer end <NUM> is elliptical), but this is not strictly required in all embodiments. For example, the receptacle <NUM> may be offset from the introducer's central axis.

The probe receptacle <NUM>, in this embodiment, comprises a generally circular receptacle wall <NUM> having an inner surface <NUM> that extends within the passage <NUM> from a distal receptacle end <NUM> to a proximal receptacle end <NUM>. The inner surface <NUM> tapers from a relatively large diameter at the proximal receptacle end <NUM> to a relatively small diameter at a distal receptacle end <NUM>. The distal receptacle end may be located at or near the distal introducer tip <NUM>. The receptacle wall <NUM> is sized to restrict the distal probe tip <NUM> from moving laterally beyond a predefined range of movement. For example, the receptacle wall <NUM> may restrict movement of the probe tip <NUM> to a range of less than <NUM> millimeter ("mm") in the lateral direction, or more preferably it may be sized to restrict any movement in the lateral direction.

The diameter of the proximal receptacle end <NUM> may have any size, but preferably is not so large as to significantly obstruct vision through the introducer <NUM>, and not so small that it is overly difficult to position the probe tip <NUM> within the receptacle <NUM> during surgery. The receptacle wall's tapered surface <NUM> helps guide the probe tip <NUM> to the proper location within the receptacle <NUM>, and the surface <NUM> may have a conical or curved profile as viewed from the lateral direction. The surface <NUM> also may have a region with a shape specifically selected to match the shape of the probe tip <NUM>. For example, if the probe tip <NUM> is hemispherical, all or a portion of the surface <NUM> may have a matching shape. As another example, if the probe tip <NUM> is cylindrical (or has a hemispherical tip with a cylindrical body immediately adjacent the tip), a distal portion of the surface <NUM> may have a matching cylindrical shape. Other alternatives will be apparent to persons of ordinary skill in the art in view of the present disclosure.

The receptacle wall <NUM> also may be shaped and sized to hold the probe tip <NUM> in close proximity to the distal introducer end <NUM>. For example the distance from the distal introducer end <NUM> to the probe tip, as measured along the longitudinal axis <NUM>, preferably is less than <NUM>, and more preferably less than <NUM>, and most preferably <NUM> or less. Where the probe tip <NUM> is at <NUM> or less from the distal introducer end <NUM> it may not be necessary to attempt to correct for this amount of displacement for purposes of navigating into the brain tissue, as this is expected to be within the normal amount of deviation of brain tissue movement within the skull. It is preferred, but not strictly required, that the probe tip <NUM> does not protrude beyond the distal introducer end <NUM>.

The introducer tip opening <NUM> (if one is provided) may be located within the probe receptacle <NUM> at the end of the receptacle wall <NUM>, such as shown in <FIG>. Alternatively, the introducer tip opening <NUM> may be located elsewhere in the distal introducer end <NUM> at a location outside the receptacle <NUM>. The probe receptacle <NUM> also may include one or more openings forming flow passages <NUM> to allow fluid to bypass the receptacle wall <NUM>; this feature can help ensure proper drainage of fluids that might otherwise accumulate at the distal end of the passage <NUM> at locations between the proximal receptacle end <NUM> and the sidewall <NUM>. More specifically, a gap <NUM> may be provided between an outer wall <NUM> of the probe receptacle <NUM> and the introducer sidewall <NUM>, and fluid may accumulate in this gap <NUM> under some circumstances. The flow passages <NUM> are provided to allow fluid to exit the gap <NUM>.

In use, the surgeon assembles the introducer <NUM> and retractor <NUM> together, places the probe tip <NUM> into the receptacle <NUM>, and uses computer-aided navigation provided by the probe <NUM> to guide the assembly to the surgery site. During navigation, the probe <NUM> indicates the position of the distal introducer end <NUM> relative to the underlying tissue via a computer screen overlay of a representation of the probe and a representation of the tissue. Throughout the process, the surgeon preferably can inspect the tissue through transparent walls of the introducer <NUM> and retractor <NUM>, and can periodically remove the probe <NUM> as necessary to obtain a better visual image or to perform intermediate procedures such as suctioning fluid and the like.

<FIG> illustrate another embodiment of an introducer <NUM>. For simplicity, only the portion of the introducer <NUM> located near the distal introducer end <NUM> is shown in these illustrations, and it will be understood that other features of the introducer <NUM> such as the remainder of the internal passage and other features described previously herein will be connected to the illustrated portion. In this embodiment, introducer <NUM> has a probe receptacle <NUM> that is suspended within the introducer <NUM> by a number of supports <NUM>.

The probe receptacle <NUM> may be located on the introducer's centerline, which is parallel to the introducer's longitudinal axis <NUM>, but other locations are possible. The probe receptacle <NUM> preferably comprises a receptacle wall <NUM> (which is circular, but can have other shapes) that extends from a proximal receptacle end <NUM> to a distal receptacle end <NUM>. The receptacle wall <NUM> has an inner surface <NUM> that tapers from a relatively large size at the proximal receptacle end <NUM> to a relatively small size at the distal receptacle end <NUM>. The inner surface <NUM> is sized and shaped to retain the distal probe tip <NUM> to prevent the probe tip <NUM> from moving laterally. For example, <FIG> shows the probe tip <NUM> at a position shortly before it fully seats in the probe receptacle <NUM>, to more clearly show that the tapered inner surface <NUM> transitions from a linearly tapering proximal surface portion <NUM> to a distal surface portion <NUM> that is shaped to match the hemispherical shape of the probe tip <NUM>. When fully seated, the probe tip <NUM> abuts the distal surface portion <NUM> in something like a ball-and-socket arrangement, with the semi-hemispherical surface of the distal surface portion <NUM> cupping and closely conforming to the hemispherical probe tip <NUM>. In other embodiments, the inner surface <NUM> may have other shapes to accommodate different shapes and sizes of probe tip <NUM>. For example, a simple conical shape can accommodate different probes having various tip diameters.

The supports <NUM> are formed as planar ribs that radiate outward from the introducer's centerline, and extend in parallel with the longitudinal axis <NUM>. In alternative embodiments, the supports <NUM> may be replaced by other shapes, such as blocks, pillars, and so on.

The probe receptacle <NUM> may be positioned adjacent to an introducer tip opening <NUM> that passes through the distal introducer end <NUM>. The introducer tip opening <NUM> and probe receptacle <NUM> are positioned such that fluid located in a gap <NUM> between the probe receptacle's outer wall <NUM> and the sidewall <NUM> can pass through the introducer tip opening <NUM> without passing through the probe receptacle <NUM>. Thus, fluid can flow through the introducer tip opening <NUM> even when the probe tip <NUM> is installed within the probe receptacle <NUM>. The probe receptacle <NUM> also may include a distal receptacle opening <NUM> passing thorough the distal receptacle end <NUM>, which provides an additional flow path when the probe is not installed in the probe receptacle <NUM> and prevents fluid from pooling in the probe receptacle <NUM>.

In the illustrated embodiment, the distal receptacle end <NUM> extends into the introducer tip opening <NUM>, such that it lies at or near the plane of the distal introducer end <NUM>. Thus, the introducer tip opening <NUM> is formed as an annular passage that surrounds the probe receptacle <NUM>, and the supports <NUM> bridge the gap between the distal introducer end <NUM> and the probe receptacle <NUM>. The supports <NUM> may include arched voids <NUM> to help reduce any disruption in the flow through the introducer tip opening <NUM> that the supports <NUM> might otherwise cause.

The placement of the distal receptacle end <NUM> within the introducer tip opening <NUM> can place the probe tip <NUM> as close as possible to the distal introducer end <NUM>. This simplifies the registration between the probe <NUM> and the introducer <NUM> because there is very little offset between their distal ends. However, this arrangement is not required in all embodiments. For example, the probe receptacle <NUM> may be moved further in the proximal direction (i.e., back into the introducer passage) to allow more fluid flow capacity through the introducer tip opening <NUM>, to make the introducer tip opening <NUM> smaller, and for other reasons. If the offset between the probe tip <NUM> and the distal introducer end <NUM> is significant, the computer system associated with the probe <NUM> can be programmed to account for this offset when indicating the position of the introducer <NUM> to the surgeon, as known in the art.

The receptacle <NUM> is preferably positioned and sized such that at least a portion of the introducer sidewall <NUM> at the distal introducer end <NUM> is visible to the surgeon while the probe tip <NUM> is installed in the receptacle <NUM>. For example, a pair of transparent faces <NUM> of the sidewall <NUM> (which may be flat as shown or curved) may be visible around the receptacle <NUM> and probe <NUM>. The surgeon can visually inspect the underlying tissue even while the probe <NUM> is in place, and can move the probe shaft <NUM> around within the passage <NUM> to alter her view without displacing the probe tip <NUM> from the receptacle <NUM>.

<FIG> illustrate another embodiment of an introducer <NUM>. As with <FIG>, only the region of the introducer <NUM> adjacent the distal introducer end <NUM> is shown. It will be understood that other features of the introducer <NUM> such as the remainder of the internal passage and other features described previously herein will be connected to the illustrated portion. In this embodiment, the introducer <NUM> has a probe receptacle <NUM> that includes a portion that is suspended within the introducer <NUM> by a number of supports <NUM>. The probe receptacle <NUM> may be located on the introducer's centerline, which is parallel to the introducer's longitudinal axis <NUM>, but other locations are possible.

The probe receptacle <NUM> preferably comprises a receptacle wall <NUM> (which is circular, but can have other shapes) that extends from a proximal receptacle end <NUM> to a distal receptacle end <NUM>. The receptacle wall <NUM> has an inner surface <NUM> that tapers from a relatively large size at the proximal receptacle end <NUM> to a relatively small size at a the distal receptacle end <NUM>. The inner surface <NUM> is sized and shaped to retain the distal probe tip <NUM> to prevent the probe tip <NUM> from moving laterally when the probe tip <NUM> is fully seated in the probe receptacle <NUM>. The inner surface <NUM> may be similar in construction to the probe receptacle <NUM> described in relation to <FIG>, or have other shapes configured to retain the probe tip <NUM>. For example, the inner surface <NUM> may comprise a proximal portion adjacent the proximal receptacle end <NUM> having a first angle θ<NUM> relative to the longitudinal axis <NUM> in the range of <NUM>°-<NUM>° (e.g., <NUM>°), an intermediate portion located distally from the upper portion having a second angle θ<NUM> relative to the longitudinal axis <NUM> in the range of <NUM>°-<NUM>° degrees (e.g., <NUM>°), and a distal portion located distally from the intermediate portion having a hemispherical or semi-hemispherical shape having a radius r in the range of <NUM>-<NUM>. This arrangement is expected to provide simple and repeatable installation of the probe tip <NUM> into the receptacle <NUM>, and provide a distinct feel to indicate when the probe tip <NUM> is fully seated.

The probe receptacle <NUM> is positioned adjacent to an introducer tip opening <NUM> that passes through the distal introducer end <NUM>. The introducer tip opening <NUM> and probe receptacle <NUM> are positioned such that fluid can pass through the introducer tip opening <NUM> without passing through the proximal receptacle end <NUM>. This allows fluid located in a gap <NUM> between the probe receptacle's outer wall <NUM> and the introducer sidewall <NUM> to flow through the introducer tip opening <NUM> when the probe tip <NUM> is installed within the probe receptacle <NUM>. In the shown embodiment, the outer wall <NUM> is shown being spaced from the sidewall <NUM> around its entire perimeter, but it will be appreciated that the outer wall <NUM> may merge with the sidewall <NUM> at some locations (such as when the introducer profile is a narrow ellipse or oval, and the receptacle <NUM> has a circular profile).

The probe receptacle <NUM> also may include a distal receptacle opening <NUM> passing thorough the distal receptacle end <NUM>, to provide an additional flow path when the probe is not installed in the probe receptacle <NUM>, and prevent fluid from pooling in the probe receptacle <NUM>. The distal receptacle end <NUM> may extend into the introducer tip opening <NUM>, such that it lies at or near the plane of the distal introducer end <NUM>. In this case, the introducer tip opening <NUM> may be formed as an annular passage that surrounds the probe receptacle <NUM> with the supports <NUM> bridging the gap between the distal introducer end <NUM> and the probe receptacle <NUM>. The supports <NUM> may include arched voids to help reduce any disruption in the flow through the introducer tip opening <NUM> that the supports <NUM> might otherwise cause. As with the embodiment of <FIG>, locating the distal receptacle end <NUM> within the introducer tip opening <NUM> can place the probe tip <NUM> as close as possible to the distal introducer end <NUM>. However, this arrangement is not required in all embodiments.

In this embodiment, the proximal receptacle end <NUM> is larger in the lateral direction (i.e., perpendicular to the longitudinal axis <NUM>) than the introducer tip opening <NUM>. This provides a relatively large probe receptacle <NUM> to help guide the probe <NUM> into place, while keeping the size of the introducer tip opening <NUM> relatively small to help prevent the possibility of brain tissue or other delicate tissue being damaged by being forced into or cut by the edges of the introducer tip opening <NUM>. <FIG> shows how this configuration helps guide the probe tip <NUM> into the probe receptacle <NUM>, even when it starts at a location that is significantly offset from the probe receptacle's centerline (which, in this example, is collinear with the geometric center of the introducer <NUM>).

Where the proximal receptacle end <NUM> is larger than the introducer tip opening <NUM>, it may be particularly favorable to provide additional provisions for assuring suitable flow through the introducer tip opening <NUM>. To this end, the probe receptacle <NUM> may include one or more (preferably three) openings at a location between the proximal receptacle end <NUM> and the distal receptacle end <NUM> to allow fluid to flow to the introducer tip opening <NUM> without passing through the proximal receptacle end <NUM>. Such openings may be, for example, slots <NUM> extending inward from the outer surface of the probe receptacle <NUM> to the introducer tip opening <NUM>. These slots <NUM> allow fluid to drain from the most distal parts of the introducer passage to prevent pooling around the outer perimeter of the probe receptacle <NUM> at the distal end of the introducer. The slots <NUM> in the shown embodiment extend in the longitudinal direction from the proximal receptacle end <NUM> to a portion of the sidewall <NUM> located adjacent the distal receptacle end <NUM>, but other embodiments may have slots having different lengths in the longitudinal direction.

Each slot <NUM> may terminate at its inner end at an annular passage <NUM> that overlies the introducer tip opening <NUM>. The annular passage <NUM> passes through the inner surface <NUM> of the receptacle <NUM> and extends to the introducer tip opening <NUM>, and is expected to help redistribute fluids passing through the introducer tip opening <NUM> into a more uniform and less restricted flow. The supports <NUM> bridge and interrupt the annular passage <NUM> to join the proximal receptacle end <NUM> to the distal receptacle end <NUM> and to suspend the distal receptacle end <NUM> at the introducer tip opening <NUM>. The slots <NUM> and annular passage <NUM> are sized to prevent the probe tip <NUM> from entering them (e.g., by having a <NUM> maximum width if the smallest probe tip <NUM> to be used is <NUM> or larger).

As with the other embodiments, the receptacle <NUM> is preferably positioned and sized such that a transparent portion of the introducer sidewall <NUM> at the distal introducer end <NUM> is visible to the surgeon while the probe tip <NUM> is installed in the receptacle <NUM>, to allow visualization of the underlying tissue while the probe <NUM> is in place.

<FIG> illustrate another embodiment of an introducer <NUM>, of which only the region of the introducer <NUM> adjacent the distal introducer end <NUM> is shown. As with the previous embodiments, it will be understood that other features of the introducer <NUM> will be connected to the illustrated portion. In this embodiment, the introducer <NUM> has a probe receptacle <NUM> having primary supports <NUM> joining a proximal receptacle end <NUM> to a distal receptacle end <NUM>. The distal receptacle end <NUM> is adjacent (and preferably within) an introducer tip opening <NUM>. The proximal receptacle end <NUM> is larger, in a direction perpendicular to the longitudinal axis <NUM> of the introducer <NUM>, than the introducer tip opening <NUM>. The structure of this probe receptacle <NUM> is similar to the one illustrated in <FIG>, and can include the same variations and features (e.g., a distal receptacle opening, etc.). The description of <FIG> applies equally to the embodiment of <FIG>.

The embodiment of <FIG> differs from <FIG> in that secondary supports <NUM> joining the proximal receptacle end <NUM> to the distal receptacle end <NUM> are provided on either side of each slot <NUM>. The secondary supports <NUM> preferably have larger voids at their distal ends to provide a more continuous flow passage adjacent the introducer tip opening <NUM>. For example, the primary supports <NUM> may be connected to the distal receptacle end <NUM> by ribs <NUM> having a lower end located within or near the introducer tip opening <NUM>, while the secondary supports <NUM> are connected to the distal receptacle end <NUM> by ribs <NUM> that are spaced above the introducer tip opening <NUM>, such as best shown in <FIG>. This arrangement provides additional structures to support the distal receptacle end <NUM> and to prevent a surgeon from lodging the probe tip <NUM> in the slots <NUM> or the gaps between the proximal receptacle end <NUM> and the distal receptacle end <NUM>, while still providing an annular passage <NUM> (<FIG>) (which may be interrupted at some locations by the primary support ribs <NUM>) at the introducer tip opening <NUM> to allow relatively free flow therethrough. Openings <NUM>, located between the secondary supports <NUM> and primary supports <NUM>, provide flow passages that pass through the inner surface of the probe receptacle <NUM> and extend along the longitudinal axis <NUM> to the introducer tip opening <NUM>, to allow vertical fluid flow at various locations. As with the previous embodiments, fluid located in a gap <NUM> between the probe receptacle's outer wall <NUM> and the introducer sidewall <NUM> can flow through the introduced tip opening <NUM> without having to pass through the proximal introducer end <NUM>, which helps reduce any flow restriction that might be caused by the probe tip <NUM>.

It is also contemplated that the primary supports <NUM> may be constructed like the shown secondary supports <NUM> (i.e., with high arched ribs <NUM> joining to the distal receptacle end <NUM>). However, the lower ribs of the primary supports <NUM> such as shown in <FIG> may be helpful to add strength and to prevent tissue from entering the introducer tip opening <NUM>. Alternatively, the secondary supports <NUM> can be structurally identical to the primary supports <NUM>, if it is found that the added support is desirable and the restriction to flow through the introducer tip opening <NUM> is not unduly compromised. Other alternatives will be apparent to persons of ordinary skill in the art in view of the present disclosure.

The probe receptacle of any given embodiment may have any suitable shape to fit any desired navigation probe. The probe receptacle may be configured to fit one particular kind of probe, or it may be configured to retain a number of different navigation probes. For example, a probe receptacle as described above with reference to <FIG> may be configured to interchangeably receive any one of four or more different probes such illustrated in <FIG>. A first probe <NUM> has a tip diameter D of <NUM> and a taper angle θ of approximately <NUM>°. A second probe <NUM> has a tip diameter D of <NUM> and a taper angle θ of approximately <NUM>°. A third probe <NUM> has a tip diameter D of <NUM> and a taper angle θ of approximately <NUM>°. A fourth probe <NUM> has a tip diameter D of <NUM> and a <NUM> diameter cylindrical shaft <NUM> extending proximally from the tip. Each of these probes can be inserted with the probe tip seated at the distal end of the receptacle, within <NUM> and more preferably within <NUM> of the distal introducer end, to hold probe tip against lateral movement.

The receptacle may be formed such that it is not likely for the surgeon to "wedge" the probe tip in place, as this may cause difficulty with removing the probe. To this end, it is preferred for the taper angle of the receptacle's inner wall to not exactly match the taper angle of any particular probe tip in such a way to lock the two parts together. It is also preferred for the material of the receptacle to be relatively hard to prevent it from deforming to allow the probe tip to become lodged therein. Polycarbonate plastic is expected to be suitable for this purpose, but other materials may be used. Of course, a surgeon applying a very large force on the probe might lodge it in the receptacle regardless of how the receptacle is designed, so it will be understood that these preferences are predicated on normal use of the instrument and are not intended to set strict requirements for all embodiments under all circumstances.

Alternatively, the receptacle may be deliberately 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 within the receptacle such that a force is required to remove the probe, or the receptacle may include thin deformable ribs that tend to grip the tip of the probe. This may require more care when removing the probe, but add the benefit of not requiring the surgeon to handhold the probe at all times.

The foregoing embodiments are expected to help surgeons use introducer and retractor systems with navigation systems. It is expected that surgeons will use the device by assembling the introducer with a retractor, placing the navigation probe in the introducer until the tip of the probe reaches the end of the probe receptacle, and then advancing the three parts forward into the tissue as a unit. During the process, the surgeon can remove the probe to get a better view into the introducer or to insert other instruments or devices into the introducer. If desired, a clamp or other device may be provided to hold the probe in place to free up the surgeon's hands for other tasks. Examples of clamps are disclosed in the aforementioned references, but other mechanisms may be used. Other uses and methods will be apparent to those of ordinary skill in the art in view of this disclosure.

The introducer tip opening may add significant benefits to the system, such as by allowing fluids to ventilate to prevent an excessive accumulation of pressure around the introducer, allowing removal of fluids, and if the opening is large enough allowing resection or manual movement of tissue adjacent the opening. The tip opening also may allow air to vent towards the tissue as the introducer is withdrawn from the retractor after the assembly is placed at the surgery site, which can help prevent the introducer from generating suction that pulls on the tissue as the introducer is withdrawn. Other benefits will be apparent in view of the this disclosure and with further use of the system.

While it is expected that the foregoing embodiments can be used "freehand" by simply placing the probe tip <NUM> into the probe receptacle, in some cases a surgeon may wish to lock the probe <NUM> in place within the introducer <NUM>. This may be accomplished by using a retaining mechanism, such as the exemplary probe retainer <NUM> shown in <FIG>.

The probe retainer <NUM> comprises a receiver <NUM> that is affixed to the introducer <NUM> by a pair of clamps <NUM>. The receiver <NUM> includes a channel <NUM> sized to receive a probe <NUM>. The channel <NUM> preferably is a closed passage having a diameter suitable to accommodate a probe <NUM>, but it may include a longitudinal slot or have a "C" or "U" shaped profile, or the like, in other embodiments. The channel <NUM> has a proximal channel end <NUM> facing towards the surgeon, and a distal channel end <NUM> that extends into the introducer <NUM>. When the probe shaft <NUM> is located in the channel <NUM>, the channel <NUM> limits and may completely restrict movement of the probe shaft <NUM> in the lateral direction.

The receiver <NUM> may be configured to selectively lock the probe <NUM> in place within the channel <NUM>. For example, the proximal channel end <NUM> may have a threaded outer surface <NUM> that is configured to engage a corresponding lock nut <NUM>, and one or more cutout sections <NUM> passing through the proximal channel end <NUM>. The threaded outer surface <NUM> and lock nut <NUM> are configured such that the lock nut <NUM> compresses the threaded outer surface <NUM> as it is tightened onto the threaded outer surface <NUM>, such as by providing one or both with a slight taper or making the lock nut's threads slightly smaller in diameter than the threads on the outer threaded surface <NUM>. The cutout sections <NUM> provide reliefs to allow the threaded surface <NUM> to move inwards as the lock nut <NUM> is tightened. Thus, as the lock nut <NUM> is tightened on the threaded outer surface <NUM>, the threaded outer surface <NUM> moves radially inwards, and an inner surface <NUM> of the proximal channel end <NUM> clamps against and secures the probe <NUM> in place. The receiver <NUM> also may include one or more retaining lips <NUM> to prevent the lock nut <NUM> from being fully removed from the receiver <NUM>.

Other locking mechanisms may be used in other embodiments. For example, the lock nut <NUM> may be replaced by a band clamp, a set screw, or other devices. Examples of alternative locks are provided in the aforementioned references, and other options will be apparent to the person of ordinary skill in the art in view of this disclosure.

In the shown embodiment, the receiver <NUM> may include a number of slots <NUM> (e.g., three slots) that extend proximally from the distal channel end <NUM>. The exemplary slots <NUM> extend longitudinally along the longitudinal axis <NUM> of the assembly, but other orientations may be used (e.g. helical). The inner surface of the channel <NUM> is also may be gently tapered such that the diameter of the channel <NUM> decreases as it approaches the distal channel end <NUM>. The final diameter of the channel <NUM> at the distal channel end <NUM> may be slightly less than the largest diameter probe <NUM> expected to be used with the device, such that the probe <NUM> is slightly compressed by the receiver <NUM> at the distal channel end <NUM>. The slots <NUM> allow the channel <NUM> to flex outwards at the distal channel end <NUM> to accommodate probes <NUM> of different sizes. This feature is expected to provide a useful slight retaining force, and may help center the probe <NUM> within the channel <NUM>.

The receiver also may be configured to direct the distal probe tip <NUM> towards a receptacle (e.g., receptacle <NUM>, <NUM>, <NUM> or <NUM>) as the probe <NUM> is installed into the introducer <NUM>. The foregoing tapered and slotted arrangement is expected to accomplish this by orienting the channel <NUM> towards a corresponding receptacle at the distal introducer tip, but other embodiments may use other configurations to do the same thing. Preferably, the channel <NUM> extends in the longitudinal direction, so that it prevents significant angulation of the probe <NUM> within the channel <NUM> (i.e., it prevents angulation that could prevent the distal probe tip <NUM> from entering the receptacle). For example, the channel <NUM> may have an inner diameter that is no more than <NUM>% of the largest probe diameter, and a length that is at least <NUM>% and more preferably at least <NUM>% of the largest probe diameter.

Despite the foregoing, in other embodiments the channel <NUM> may comprise a simple ring or passage that is not tapered and does not include slots, or the taper and slots may be replaced by a flexible diaphragm or cantilevered arms that help center the probe <NUM> within the channel <NUM>. Other alternatives will be apparent to persons of ordinary skill in the art in view of the present disclosure.

The clamps <NUM> are attached to the receiver <NUM>, and configured to hold the receiver <NUM> at a fixed location relative to the introducer <NUM>. The receiver <NUM> may be centered on the introducer <NUM>, such as shown, or it may be offset from the introducer's centerline. In this embodiment, the clamps <NUM> are connected to the receiver <NUM> by clamp arms <NUM> that are shaped to generally match the shape of the introducer sidewall <NUM> at the proximal introducer end <NUM>. Thus, each clamp arm <NUM> has an opening <NUM> through which the surgeon can view into the introducer passage <NUM>.

Each clamp <NUM> comprises a tab <NUM> that is shaped to receive a user's finger, and a hook <NUM> that is shaped to wrap around a corresponding lip <NUM> (<FIG>) on the introducer. The clamp arms <NUM> are located between the tab <NUM> and the hook <NUM>. The clamp arms <NUM> and hooks <NUM> are movable between a latched position in which the hooks <NUM> are relatively close to one another, and an unlatched position in which the hooks <NUM> are relatively far from one another. In their latched position, the hooks <NUM> are spaced by a first distance at which they wrap around the corresponding lips <NUM> to secure the probe retainer <NUM> to the introducer <NUM>. The hook spacing in the latched position may be slightly greater than their natural resting position when not attached to an introducer <NUM>. Thus, when attached to the introducer <NUM>, the clamp arms <NUM> may be under a slight bending force caused by flexing the hooks <NUM> from their resting position to their latched position. This can help provide a stronger locking connection, and may reduce the likelihood of shifting or moving when connected.

When the surgeon pinches the tabs <NUM> together, the clamp arms <NUM> flex and provide a fulcrum about which the hooks <NUM> rotate until they are located at a second distance from one another. In this position, the hooks <NUM> release the lips <NUM> and the probe retainer <NUM> can be removed from the introducer. The clamps <NUM> may be reinstalled onto the introducer <NUM> by reversing this operation, and the hooks <NUM> may include ramped surfaces to allow them to be snapped onto the lips <NUM> simply by pressing the probe retainer <NUM> against the proximal introducer end <NUM>.

In the exemplary embodiment, there are two clamp arms <NUM>, each of which has two spaced portions that surround an opening <NUM> to allow visualization into the introducer <NUM>. Each clamp arm <NUM> is connected to the receiver <NUM> at two locations on opposite sides of the receiver <NUM>. The attachments between the receiver <NUM> and the clamp arms <NUM> may have buttresses <NUM> to increase the rigidity of the connection. This is expected to help the clamp arms <NUM> flex in a more predictable manner during the detachment and installation process.

The foregoing clamp <NUM> arrangement is expected to provide simple and reliable engagement to selectively connect the probe retainer <NUM> to the introducer <NUM>. However, other embodiments may use different structures to hold the probe in place. For example, the flexible clamp arms <NUM> may be replaced by more rigid members having a mechanical pivot such as a pivot pin or the like and a return spring to bias the hooks <NUM> to the clamped position. As another example, each clamp arm <NUM> may have a single portion located on one side of the introducer <NUM>, rather than two spaced portions, and the clamps <NUM> may be turned <NUM>° relative to the shown position such that the grip the introducer <NUM> from the side rather than from the top. Other alternatives will be apparent to persons of ordinary skill in the art in view of the present disclosure.

<FIG> show the embodiment of <FIG> as it appears when installed on an exemplary introducer <NUM>. The introducer <NUM> is shown assembled with a corresponding retractor <NUM>. The introducer <NUM> preferably includes a probe tip receptacle such as those described previously herein, but it is also envisioned that the probe retainer <NUM> may be used with introducers that do not have a probe tip receptacle, such as those discussed with reference to <FIG>. The assembly of the probe retainer <NUM> and navigation probe <NUM> preferably can be removed from or installed into the introducer <NUM> without separating the introducer <NUM> from the retractor <NUM>. This provides rapid access to the introducer interior, if necessary.

<FIG> show another embodiment of a probe retainer <NUM>. In this case, the probe retainer includes a receiver <NUM> that can be affixed to an by a pair of clamps <NUM>. This embodiment is generally the same as the embodiment of <FIG>. However, in this embodiment the mechanism for locking the probe shaft in place is different. The receiver channel <NUM> is formed with a threaded proximal end <NUM>, a conically tapered central portion <NUM>, and a relatively narrow distal portion <NUM>. The locking nut <NUM> comprises a proximal knob portion <NUM> that is adapted for use by the surgeon (e.g., knurled, or otherwise shaped to be engaged by fingers or a tool), a male-threaded central portion <NUM>, and a tapered conical distal end <NUM> having one or more longitudinal slots <NUM>. A central passage <NUM> passes through the locking nut <NUM> to receive the probe shaft. The threads <NUM> of the locking nut <NUM> are configured to thread into the threads <NUM> of the receiver <NUM>, and the conical distal end <NUM> of the locking nut <NUM> is dimensioned to fit into the conical central portion <NUM> of the receiver <NUM>. The locking nut <NUM> is advanced into the receiver <NUM> by rotating it relative to the receiver <NUM>. When the tapered end <NUM> of the locking nut <NUM> engages the tapered central portion <NUM> of the receiver channel <NUM>, contact between the parts flexes the tapered end <NUM> radially inwards to compress against the probe shaft. Thus, the locking nut <NUM> can cooperate with the receiver <NUM> to engage and hold the probe shaft at a fixed location.

The locking nut <NUM> may be retained by one or more features that interlock with the receiver <NUM>. For example, the receiver <NUM> may have one or more hooks <NUM> that surround a lip <NUM> that extends radially from the knob portion <NUM> of the locking nut <NUM>. These retaining features inhibit the locking nut <NUM> from accidentally separating from the receiver <NUM> when the locking nut <NUM> is fully-loosened. However, in some embodiments, the hooks <NUM> may be designed to be deformable to allow the locking nut <NUM> to be removed. Other alternatives and variations will be apparent to persons of ordinary skill in the art in view of the present disclosure.

It will be appreciated that the foregoing embodiments may be modified in various ways. As one example, features disclosed in one embodiment may be used with any of the other embodiments. As another example, the probe receptacles described herein can be formed integrally with the introducer by additive manufacturing or molding (the illustrated embodiments show various configurations in which conventional two-part injection molding processes may be used to make the introducer and probe receptacle as a single integrally molded part), or formed separately and attached to the introducer. As another example, the probe receptacle may have any sidewall profile shape, rather than the generally circular shapes shown in the embodiments. The probe receptacles also may have any combination of conical, cylindrical, hemispherical, or other shapes. It is also envisioned that the probe receptacle may have openings such as the flow passages of <FIG> and slots of the later embodiments, even when the introducer does not have an introducer tip opening, which can be beneficial to displace fluid from the receptacle to allow free entry of the probe tip. Other alternatives will be apparent to persons of ordinary skill in the art in view of the present disclosure.

Claim 1:
A surgical navigation probe assembly (<NUM>, <NUM>) comprising:
a receiver (<NUM>, <NUM>) having:
a receiver channel (<NUM>, <NUM>) extending in a longitudinal direction and configured to receive a navigation probe shaft in a proximal open end of the receiver channel, and limit movement of the navigation probe shaft in a lateral direction that is perpendicular to the longitudinal direction, and
a first threaded surface (<NUM>, <NUM>); and
a lock (<NUM>, <NUM>) having:
a central passage (<NUM>) extending in the longitudinal direction, and
a second threaded surface (<NUM>);
wherein the lock and receiver are movable between a first configuration in which the lock and receiver allow the navigation probe shaft to move relative to the lock and receiver along the longitudinal direction, and a second configuration in which the lock and receiver prevent the navigation probe from moving relative to the lock and receiver along the longitudinal direction; and,
wherein the lock is rotatable relative to the receiver to engage the first threaded surface with the second threaded surface to thereby move the lock and receiver between the first configuration and the second configuration.