阅读说明：本技术 带有具有不透明部件的透明末端的套管和闭塞器 (Cannula and obturator with transparent tip having opaque member ) 是由 P·G·戴维斯 R·冢岛 D·J·富勒 于 2020-02-18 设计创作，主要内容包括：一种套管和闭塞器系统具有闭塞器,该闭塞器具有窄轴和较大的远侧末端,其可透射可见光(透明或半透明)。闭塞器末端具有尖而锐利的锥形远侧末端并且包括沿闭塞器末端的中心轴线布置的光学不透明部件(例如杆),其用于防止图像反转。(A sleeve and obturator system has an obturator with a narrow shaft and a larger distal tip that is transmissive to visible light (transparent or translucent). The obturator tip has a pointed and sharp tapered distal tip and includes an optically opaque member (e.g., a rod) disposed along a central axis of the obturator tip for preventing image reversal.)

1. A cannula system for accessing a blood clot in a brain of a patient, the cannula system comprising:

a cannula, the cannula comprising: a cannula tube having a proximal end and a distal end; and a lumen extending from the proximal end to the distal end; and

an obturator, the obturator comprising: an obturator shaft having a proximal end and a distal end; and an obturator tip disposed on a distal end of the obturator shaft, the obturator tip being light transmissive, a cross-section of the obturator tip closely matching a cross-section of the sleeve, the obturator tip having a tapered distal tip, the obturator is slidable within the cannula tube and positionable within the cannula tube, such that the proximal end of the obturator shaft extends proximally out of the proximal end of the sleeve while the tapered distal tip extends out of the distal end of the sleeve, wherein the cross-section of the obturator shaft is smaller than the lumen of the cannula and smaller than the cross-section of the obturator tip, whereby, when the obturator tip is positioned within the sleeve such that the tapered distal tip extends out of the distal end of the sleeve, a proximal surface of the obturator tip is visible through the lumen from the proximal end of the sleeve; and

an optically opaque component positioned within the tapered distal tip along a central longitudinal axis of the obturator tip.

2. The cannula system of claim 1, wherein:

the obturator tip includes a proximal portion, a central cylindrical portion, and the tapered distal tip is a distal tapered portion, and the obturator further includes an aperture extending distally from a proximal-most end of the proximal portion into the central cylindrical portion, and a distal end of the shaft is disposed within the aperture, wherein the aperture has a length such that when a proximal end of the obturator shaft extends proximally out of a proximal end of the sleeve, the tapered distal tip extends out of a distal end of the sleeve, the aperture terminating distally at a location distal of a distal end of the sleeve tube.

3. The cannula system of claim 2, wherein:

the shaft extends distally into a distal tapered portion of the obturator tip, and the opaque member comprises a distal end of the shaft.

4. The cannula system of claim 2, wherein:

the shaft terminates distally in a proximal portion of the obturator tip, and the opaque component is a separate component from the shaft.

5. The cannula system of claim 1, 2, 3 or 4, wherein the cannula system further comprises:

a nerve navigation stylet having a distal end and a proximal end, the nerve navigation stylet sized and dimensioned for insertion into the lumen of the obturator shaft;

wherein when the proximal end of the obturator shaft extends proximally out of the proximal end of the cannula, the tapered distal tip extends out of the distal end of the cannula and the nerve navigation stylet is positioned within the lumen of the obturator shaft, the nerve navigation stylet terminating distally at a location distal of the distal end of the cannula tube.

6. The cannula system of claim 5, wherein:

the nerve navigation stylet terminates distally within a distal tapered portion of the obturator tip, and the opaque member comprises a distal end of the nerve navigation stylet.

7. The cannula system of claim 1, 2, 3, or 4, wherein:

the apex angle of the distal tapered portion is in the range of 35 degrees to 45 degrees.

8. The cannula system of claim 1, 2, 3, or 4, wherein:

the distal tapered portion includes a sharpened distal tip extending distally of the cannula tube to facilitate advancement of the assembly through brain tissue.

9. A cannula system for accessing a blood clot in a brain of a patient, the cannula system comprising:

a cannula, the cannula comprising: a cannula tube having a proximal end and a distal end; and a lumen extending from the proximal end to the distal end; and

an obturator, the obturator comprising: an obturator shaft having a proximal end and a distal end; and an obturator tip disposed on a distal end of the obturator shaft, the obturator tip being light transmissive, a cross-section of the obturator tip closely matching a cross-section of the sleeve, the obturator tip having a distal tip, the obturator is slidable within the cannula tube and positionable within the cannula tube, such that the proximal end of the obturator shaft extends proximally out of the proximal end of the sleeve while the tapered distal tip extends out of the distal end of the sleeve, wherein the cross-section of the obturator shaft is smaller than the lumen of the cannula and smaller than the cross-section of the obturator tip, whereby, when the obturator tip is positioned within the sleeve such that the tapered distal tip extends out of the distal end of the sleeve, a proximal surface of the obturator tip is visible through the lumen from the proximal end of the sleeve; and

a light disposed within the obturator tip.

10. A method of inserting a cannula into a patient to access a surgical workspace in the patient, the method comprising the steps of:

providing a cannula system, the cannula system comprising:

a cannula, the cannula comprising: a cannula tube having a proximal end and a distal end; and a lumen extending from the proximal end to the distal end; and

an obturator, the obturator comprising: an obturator shaft having a proximal end and a distal end; and an obturator tip disposed on a distal end of the obturator shaft, the obturator tip being light transmissive, a cross-section of the obturator tip closely matching a cross-section of the sleeve, the obturator tip having a distal tip, the obturator is slidable within the cannula tube and positionable within the cannula tube, such that the proximal end of the obturator shaft extends proximally out of the proximal end of the sleeve while the distal tip extends out of the distal end of the sleeve, wherein the cross-section of the obturator shaft is smaller than the lumen of the cannula and smaller than the cross-section of the obturator tip, whereby, when the obturator tip is placed within the sleeve such that the distal tip extends out of the distal end of the sleeve, a proximal surface of the obturator tip is visible through the lumen from the proximal end of the sleeve; and

a neuro-navigation stylet;

assembling the cannula tube, the obturator and the nerve navigation stylet such that the obturator is placed within the cannula tube with the obturator tip extending distally from the distal end of the cannula and the distal end of the nerve navigation stylet extending distally from the obturator shaft into the distal tip of the obturator tip to dispose an opaque component within the distal tip;

advancing the assembled cannula system into the body while viewing body tissue distal to the cannula tube from the proximal end of the cannula tube through the obturator tip.

11. A method of inserting a cannula into a patient to access a surgical workspace in the patient, the method comprising the steps of:

providing a cannula system, the cannula system comprising:

a cannula, the cannula comprising: a cannula tube having a proximal end and a distal end; and a lumen extending from the proximal end to the distal end; and

an obturator, the obturator comprising: an obturator shaft having a proximal end and a distal end; and an obturator tip disposed on a distal end of the obturator shaft, the obturator tip being optically transparent, a cross-section of the obturator tip closely matching a cross-section of the sleeve, the obturator tip having a distal tip, the obturator is slidable within the cannula tube and positionable within the cannula tube, such that the proximal end of the obturator shaft extends proximally out of the proximal end of the sleeve while the distal tip extends out of the distal end of the sleeve, wherein the cross-section of the obturator shaft is smaller than the lumen of the cannula and smaller than the cross-section of the obturator tip, whereby, when the obturator tip is placed within the sleeve such that the distal tip extends out of the distal end of the sleeve, a proximal surface of the obturator tip is visible through the lumen from the proximal end of the sleeve;

wherein the obturator tip further comprises an opaque member disposed in the distal tip; and

assembling the cannula tube and the obturator such that the obturator is positioned within the cannula tube, wherein the obturator tip extends distally from the distal end of the cannula such that an opaque component within the distal tip is disposed distally of the distal end of the cannula tube;

advancing the assembled cannula system into the body while viewing body tissue distal to the cannula tube from the proximal end of the cannula tube through the obturator tip.

Technical Field

The invention described below relates to the field of minimally invasive surgery.

Background

In our previous us patent application, we disclose a cannula and camera system with an obturator that includes a small diameter shaft and a larger diameter transparent obturator tip that occludes the cannula at its distal end. Using the system, the surgeon may advance the sleeve into the brain while viewing tissue distal to the obturator tip through the obturator tip. The obturator tip may invert the image of the tissue distal to the obturator tip, presenting an image of the tissue distal to the tip (at its distal surface) at its proximal surface, which image is inverted according to its configuration.

Disclosure of Invention

The following devices and methods provide improved visualization of the brain during minimally invasive surgery. The device includes: the cannula system is provided with a camera on the proximal end of the cannula and can observe the lumen of the cannula and tissues in the lumen and below the lumen; and an obturator comprising a narrow shaft and a larger distal tip that is visible light transmissive (transparent or translucent) such that tissue distal to the tip is at least partially visible through the tip from the proximal end of the cannula. The obturator tip preferably has a pointed and sharp tapered distal tip and includes an optically opaque member (e.g., a rod) disposed along a central axis of the obturator tip for preventing image reversal.

The small cross-section obturator shaft is much smaller than the inner diameter of the sleeve, providing a substantial annular or circular space between the shaft and the sleeve wall to provide good visibility of the proximal surface of the obturator tip (from the camera). If necessary, a light may be provided in the sleeve to illuminate the distal end of the obturator tip and the tissue near the sleeve or the distal end of the sleeve (illumination may instead be provided by a light source located outside the assembly, or by a light mounted on the proximal end of the sleeve, or by any combination of the foregoing). Light reflected by tissue near the distal surface of the obturator tip passes through the obturator and exits the proximal surface of the obturator tip so that a surgeon inserting or manipulating the assembly can easily see the obturator tip is adjacent to brain tissue (white to gray) or blood (red to black).

Drawings

Fig. 1 shows a head of a patient having an area requiring surgical intervention.

Fig. 2 to 5 show a sleeve and obturator, wherein the obturator is provided with an opaque member within the transparent tip.

Detailed Description

Fig. 1 shows a patient 1 with a blood clot 2 in a brain 3 requiring surgical intervention. The cannula 4 has been inserted into the brain with the distal end of the cannula near the blood clot. (although illustrated in the context of brain surgery, the system may be used in any procedure.) a camera 5 is mounted on the proximal edge of the cannula, with a portion of the camera suspended over the edge of the cannula and disposed over the lumen of the cannula, and operable to acquire video or still images of a blood clot or other tissue at the distal end of the cannula. The cannula comprises a cannula tube 6 having a distal end 6d adapted to be inserted into the body of a patient and a proximal end 6p which remains outside the body during use. The camera 5 is mounted on the proximal end 6p of the cannula tube by a mounting structure 7 fixed to the proximal end of the cannula. A camera, which may include or be equipped with prisms, reflectors or other mirror structures or optical elements, is suspended above the lumen 8 of the cannula tube. If the camera is small compared to the cannula lumen, a camera without a prism or reflector may be used and may be oriented with its visual axis aligned along the long axis of the cannula.

Fig. 1 and 2 also show the obturator 9. The obturator comprises an obturator tip 10, a shaft 11 and a handle 12. The obturator tip is preferably a solid structure having a conically convex distal surface 10d, a conically convex proximal surface 10p and an axially short circumferential surface 10 c. The tip has an outer diameter (transverse diameter, along a plane perpendicular to the long axis of the cannula, and corresponding to the cross-sectional diameter of the cannula) in the region of the circumferential surface that closely matches the inner diameter of the cannula but allows easy longitudinal translation of the tip through the lumen of the cannula. The tip configured as shown in fig. 1 will act as a lens such that light rays (represented by arrows) are refracted through the tip and bent such that any "image" passing through the tip (when formed as shown) can be reversed. The tip may have a straight longitudinal cross-section with a central cylindrical portion and a distal tapered portion and a proximal tapered portion (as shown) or more rounded sections. The distal taper preferably terminates in a sharp tip preferably used in the brain. As shown, the preferred tapered end has an apex angle of about 35 ° to 45 °. A sharp distal tip extending toward the distal end of the cannula tube helps to advance the assembly through the brain tissue. The distal and proximal surfaces need not be symmetrical about the longitudinal axis or symmetrical about the transverse axis. For example, the distal surface may be pointed, having a straight line cross-section, while the proximal surface is pointed, rounded or flat. While not preferred for use in the brain, the distal surface of the obturator tip may be unsharpened, e.g., spherical or spheroidal, and the entire obturator tip may be formed as a sphere, ellipsoid, prolate ellipsoid (football, rugby) and oblate spheroid or ovoid (egg-shaped).

The obturator tip is optically transparent, rather than opaque, and may be optically transparent or translucent. The transmissivity of the tip need only be sufficient in the visible spectrum to pass the color of tissue in contact with the distal surface, given the brightness of any illumination provided by the light source, to provide sufficient transmitted light to the camera and/or the surgeon's eye to allow the color of tissue surrounding the distal tip to be discerned from the light transmitted through the proximal surface of the tip. The obturator tip has a cross-section that closely matches the cross-section of the sleeve and is slidable within the sleeve tube and positionable within the sleeve tube such that the proximal end of the obturator shaft extends proximally out of the sleeve proximal end and the tapered distal tip extends out of the sleeve distal end. The obturator shaft has a cross-section smaller than the lumen of the sleeve and smaller than the cross-section of the obturator tip so that when the obturator tip is disposed within the sleeve such that the tapered distal tip extends out of the distal end of the sleeve, the proximal surface of the obturator tip is visible through the lumen from the proximal end of the sleeve.

The tip may be made of glass, silica, acrylic, polycarbonate, silicone, nylon, polyamide, or copolymers or any other material suitable for use in a medical device. The obturator tip surface may be polished or frosted. The obturator tip may optionally include a radiopaque substance (e.g., an element or compound, such as platinum particles) to make the tip radiopaque so that it appears clearly under fluoroscopy during surgery. The obturator tip may optionally include a sensor, such as a pH sensor, impedance sensor, force sensor, glucose sensor, or the like, to help detect blood clots or CSFs and distinguish them from surrounding brain tissue.

Although the camera head assembly is located at the distal end of the cannula tube, the proximal surface of the tip, which tapers to a small diameter in the proximal direction, also provides clearance for the tip when the obturator must be removed to make room for other equipment.

As shown in fig. 2-5, the obturator tip is modified by including one or more opaque members (e.g., a rod 13 or any opaque substance for preventing image reversal) disposed along the central axis of the obturator tip. The opaque member extends through the central cylindrical portion defined by the circumferential surface 10c and a majority of the distal tip of the obturator tip (i.e., the distal tapered portion or the portion bounded by the tapered convex distal surface 10 d). The opaque member is disposed along the central long axis 10L of the obturator tip and is preferably coaxial with the obturator shaft, leaving the periphery of the obturator tip clear to maximize the passage of light, and is preferably a single discrete member or a single compact mass. Due to the presence of such opaque parts, the lens effect of the obturator tip will be destroyed and an image of the tissue on the left side of the distal tip will be presented to the surgeon on the left side of the proximal surface, while an image of the tissue on the right side of the distal tip will be presented to the surgeon on the right side of the proximal surface, etc. Also shown in fig. 2 and 3, the proximal tapered portion of the obturator tip includes a bore 14 that receives the distal end of the obturator shaft. The bore may terminate distally within the proximal tapered portion, or within the central cylindrical portion, or within the distal tapered portion. The opaque part 13 is also provided within the bore, and this additional bore 14d may be of a smaller diameter than the bore which receives the shaft 11, or it may be of the same diameter (and may be formed as a continuation of the shaft bore 14, or may be formed by the distal surface so that it is not visible to the shaft bore). As shown in fig. 3, the opaque member may be provided as a member 13 separate from the obturator shaft 11 and having a transverse dimension (radial diameter, for example, if the radial cross-section is circular) smaller than that of the obturator shaft 11. In embodiments where the bore housing the obturator shaft terminates in a distal tapered portion, the obturator shaft distal end 16d may also terminate in the distal tapered portion, and the distal tip of the obturator shaft may serve as the optically opaque member 13, such that the opaque member is not a separate member from the obturator shaft 11. This is shown in fig. 4, where the obturator tip comprises a proximal portion 10p and a central cylindrical portion 10c, the tapered distal tip 10d is a distal tapered portion, and the obturator further comprises an aperture 14, 14d extending distally from the proximal-most end of the proximal portion into the central cylindrical portion, and where the distal end 11d of the shaft is disposed within the aperture, the aperture having a length such that when the proximal end of the obturator shaft extends proximally out of the sleeve proximal end, the tapered distal tip extends out of the sleeve distal end, the aperture 14, 14d terminating distally at a location distal to the distal end of the sleeve tube. In this embodiment, the opaque member may comprise the distal end 11d of the shaft. The transverse dimension of the opaque member/distal end of the obturator shaft may have a smaller transverse dimension than the obturator shaft 11, or, as shown, it may have the same transverse dimension as the obturator shaft.

In embodiments where the shaft bore terminates in a proximal tapered portion or central cylindrical portion, the nerve navigation stylet distal tip 16d can extend distally beyond the shaft bore 14 (accommodating the larger bore of the shaft 11) and into the distal tapered portion (in a smaller bore 14d extending beyond the shaft bore in a smaller diameter than the shaft bore), e.g., into a smaller diameter bore extending distally from the shaft bore, to serve as an opaque member. This is illustrated in fig. 5, where the distal end of the navigation stylet extends well beyond the open distal end of the cannula tube and into the distal tapered portion of the tip of the obturator, which, when assembled with the cannula tube, extends through the open distal end of the cannula tube. In this embodiment, the neuro-navigation stylet has a distal end and a proximal end, and is sized and dimensioned for insertion into the lumen of the obturator shaft such that when the proximal end of the obturator shaft extends proximally out of the proximal end of the cannula, the tapered distal tip extends out of the distal end of the cannula, and the neuro-navigation stylet is positioned within the lumen of the obturator shaft with the distal end of the neuro-navigation stylet terminating distally at a location distal of the distal end of the cannula tube. The distal end of the nerve navigation stylet may be used as an opaque member.

The shaft 11 may be a solid rod or tube having a small diameter or cross-section compared to the cannula lumen and obturator tip so that the tip proximal surface can be seen from the cannula proximal end. If provided as a conduit, the lumen of the shaft may house a neuro-navigation stylet or probe 15 having a marker detectable by the neuro-navigation system for guiding the assembly into the brain. As shown, the shaft 16 of the neuro-navigation stylet may be inserted into the lumen of the tubular shaft so that the assembled cannula, obturator and stylet may be tracked by the neuro-navigation system by tracking the markers 17 on the frame 18 to facilitate accurate placement of the distal tip of the assembly. The shaft 11 may also accommodate a neural starburst connection (nero starburst connection). In embodiments including a nerve navigation stylet, the distal tip of the stylet may terminate at a location within the obturator shaft, and may terminate proximal to the obturator tip, or at a location within, near, or distal to the distal edge of the cannula.

In use, the surgeon will assemble the cannula tube, obturator and optional nerve navigation stylet for insertion into the patient to access the surgical workspace. For example, the method may entail providing a cannula system including a cannula tube, an obturator, and a nerve navigation stylet, and assembling the cannula tube, the obturator, and the nerve navigation stylet such that the obturator is disposed within the cannula tube with the obturator tip extending distally from the cannula distal end and the nerve navigation stylet extending distally from the obturator shaft into a distal tip of the obturator tip to dispose an opaque member within the distal tip and advancing the assembled cannula system into the body while viewing body tissue located distally of the cannula tube through the obturator tip from a proximal end of the cannula tube. Without using a nerve navigation stylet as an opaque component, the method may entail providing a cannula system including a cannula tube and an obturator, wherein the obturator tip further includes an opaque component disposed in the distal tip, and assembling the cannula tube and obturator such that the obturator is disposed within the cannula tube, wherein the obturator tip extends distally from the cannula distal end such that the opaque component within the distal tip is disposed distal of the distal end of the cannula tube, and advancing the assembled cannula system into the body while viewing body tissue distal of the cannula tube through the obturator tip from the proximal end of the cannula tube.

To aid in visualization, a light may be incorporated into the obturator tip to project light onto the tissue distal to the tip and make it easier to see the tissue through the obturator tip from the proximal end of the cannula tube. As shown in fig. 3, a light such as an LED 19 may be provided within the distal tapered portion and may be embedded in the material of the obturator or fixed to the bottom of the bore 14d which receives the opaque member. The LED may instead be disposed within the proximal portion (fig. 3) or the cylindrical portion (fig. 4) and may be embedded in the material of the obturator or fixed to the bottom of the bore 14 housing the obturator shaft 11. In embodiments where the opaque member is omitted, a light source may be employed. The wiring required to power the lamp may be disposed within or around the obturator shaft.

While the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the inventions. Elements of various embodiments may be combined into each of the other categories to obtain the benefits of those elements in combination with those other categories, and various beneficial features may be used alone or in combination with each other in embodiments. Other embodiments and configurations may be devised without departing from the spirit of the inventions and the scope of the appended claims.