CN110384474B

CN110384474B - Intracranial endoscope and method of use thereof

Info

Publication number: CN110384474B
Application number: CN201910326901.2A
Authority: CN
Inventors: 黄博浩; 林圣棋; 张锋政
Original assignee: Clearmind Biomedical Inc
Current assignee: Clearmind Biomedical Inc
Priority date: 2018-04-23
Filing date: 2019-04-23
Publication date: 2022-03-08
Anticipated expiration: 2039-04-23
Also published as: CN110384474A; TW201944956A; TWI726309B

Abstract

An intracranial endoscope and method of use thereof, wherein the endoscope is particularly suited for intracranial surgery, in some instances the endoscope is rigid except for a tilt/bend portion near the distal end of a rigid tube that is inserted into the skull of a patient, the degree and direction of tilt of the distal end being controlled by a finger-operated control at the handle of the endoscope. Some examples use telescoping tubes that allow for customization of endoscope dimensions for a particular procedure. The distal portion of the endoscope, supplied in sterile packaging, may be disposable for a single procedure, given the particularly high risk of contamination of intracranial and certain other interventions, and the fact that it is difficult or impossible to effectively autoclave or otherwise effectively sterilize the heat-sensitive components of certain endoscopes.

Description

Intracranial endoscope and method of use thereof

Reference to related applications

The present patent application is a partial continuation application of united states application No. 15/364,952 filed on 30/11/2016 in 2016 and permitted on 26/1/2018 that (a) claims the benefit of united states provisional application No. 62/299,307 filed on 24/2/2016 in 2016 and (b) is a partial continuation application of PCT application No. PCT/US2015/52152 filed on 25/9/2015 in 2015, which claims the benefit of 62/056,617 filed on 29/9/2016, 62/063,114 filed on 13/2014, and 62/084,584 filed on 26/11/2014. The patent application identified in this paragraph, as well as other publications identified in the remainder of this patent specification, are incorporated herein by reference, including patents as well as published and unpublished patent applications.

Technical Field

This patent specification is in the field of intracranial endoscopy, and in general, certain aspects of the disclosed devices and methods additionally relate to otorhinolaryngological, cranio-basilar, and neurosurgery.

Background

Intracranial endoscopes are investigated in the following documents: gaab MR, instrument: endoscopes and devices, world neurosurgery 79[2s ]: s14.E1-S14.E21, month 2 of 2013. Another example of an intracranial endoscope is discussed in the following documents: schroeder HWS, new multipurpose ventriculoscope, neurosurgery, vol 62, 2 nd, 2008/2, pages 489 to 492. Other examples of endoscopes are discussed in the following documents: US 1010/0022824a1, WO 2013/082497a1, US 2012/0330196a1, US 2009/0054733a1, 2009/0198216a1, WO 2010/126586a1, US 2004/0167542, US 2008/0154181a1 and US 2014/0148727a 1.

Disclosure of Invention

The invention discloses an endoscope particularly suitable for intracranial surgery. Some disclosed examples are rigid, except for a tilting/bending portion near the distal end of a portion that is inserted into the skull of a patient and controlled using a controller at the handle of the endoscope to perform bi-directional tilting within a specified degree. Some examples use telescoping tubes that allow for customization of endoscope dimensions for a particular procedure. Some examples of endoscopes described are single-use devices that are disposable, or have at least a major portion that is disposable, to avoid a particularly high risk of contamination to the intracranial and certain other interventions. Portions of conventional endoscopes that enter the skull may be difficult to sterilize effectively and efficiently in an autoclave, especially when the endoscope contains heat sensitive components.

One disclosed example is an intracranial endoscope comprising: an internally threaded rigid outer tube (16) having opposite coupling and screwing ends; an externally threaded intermediate tube (14) which is a rigid tube which is screwed into the outer tube from the screw-in end for relative rotation therewith, thereby telescoping between an extended position and a retracted position; an inner tube (10) having a proximal end portion partially within the intermediate tube (14) and a distal end portion shaped, sized and configured for insertion into the skull of a patient; a stopper (18, 618k) mounted at a distal end of the intermediate tube remote from the coupling end of the outer tube for axial movement relative to the intermediate tube, and a biasing element (20) biasing the stopper in a distal direction; wherein the inner tube has a beveled/curved portion (10a) adjacent its distal end and an extended position and a retracted position relative to the intermediate tube; a suction/irrigation tube (8, 8a) sliding in the inner tube between an extended position in which the suction/irrigation tube projects distally from the inner tube and a retracted position; an illumination module (701, 702; 802, 803) and an imaging module (703, 801) at a distal end of the inner tube, wherein the illumination module is configured to illuminate a field of view within a skull of the patient and the imaging module is configured to capture and supply images of the field of view for display to a user; a handle (100, 500, 600, 900) configured to be held by a user's hand and having a distal portion coupled to the coupling end of the outer tube, and a proximal portion, the handle including a suction port coupler (100a) and an irrigation port coupler (100b) at the proximal portion of the handle, and user-operated controls to: (i) one or more suction and irrigation controllers (100c, 100d, 410, 418a, 418b, 418c, 502, 602, 900c, 900d) configured to control flow between the suction/irrigation tube and the suction and irrigation port ports, (ii) a tilt/bend controller (201, 301, 501, 601, 901) operably associated with the tilted/bent portion of the inner tube to control the direction and degree of tilt/bending thereof; and (iii) an extension-retraction controller (204, 208, 410, 412, 414, 416) operatively associated with the suction/irrigation tube to control the extent to which the distal end of the suction/irrigation tube protrudes distally from the inner tube.

In some embodiments, the intracranial endoscope can further include a hollow tube (804a) surrounding the distal portion of the suction/irrigation tube and having a distal end that protrudes distally from the inner tube and is angled in the shape of a hypodermic needle.

In some embodiments, the aspiration/irrigation tube has a distal end (8a) that is angled in the shape of a hypodermic needle.

In some embodiments, the intracranial endoscope can further comprise a hollow projection from the distal end of the inner tube, the hollow projection having a pointed distal end that is angled in the shape of a hypodermic needle, and wherein the suction/irrigation tube has a pointed distal end that is angled in the shape of a hypodermic needle, and the two tips are diametrically opposed. Including both the angled distal end of the hollow tube and the angled distal end of the suction irrigation tube with their tips at diametrically opposed locations.

In some embodiments, the stopper includes a rim configured to press against the skull or other head surface of the patient while the inner tube extends into the skull of the patient a distance that is at least partially limited by the position of the stopper relative to the inner tube.

In some embodiments, the stopper includes two or more tabs extending radially from a central region thereof, the tabs being configured to press against the skull or other head surface of the patient while the inner tube extends into the skull of the patient a distance that is at least partially limited by the position of the stopper relative to the inner tube.

In some embodiments, the stopper includes an opening configured to allow cerebrospinal fluid to flow through the opening while the stopper is pressed against the patient's skull or other head surface and the inner tube is inserted into the patient's skull.

In some embodiments, the one or more aspiration and irrigation controls comprise one or more user-operated buttons configured to move between positions that control flow into or out of the distal tip of the aspiration/irrigation tube.

In some embodiments, the one or more suction and irrigation controls comprise a single switch that moves in one direction to connect the suction/irrigation tube to the suction source and in another direction to connect the suction/irrigation tube to the irrigation material source.

In some embodiments, the tilt/bend controller comprises a thumb-operated joystick.

In some embodiments, the tilt/bend controller is configured to tilt/bend the distal portion of the inner tube in at least two directions, and in some embodiments more than two directions, relative to the longitudinal axis of the outer tube.

In some embodiments, the imaging module includes a control circuit housed in the handle.

In some embodiments, the endoscope includes a display operatively associated with the imaging module to display intracranial images taken therethrough.

In some embodiments, the outer tube and the intermediate tube are configured to telescope the intermediate tube from the outer tube to the distal end within a first selected distance range, and the inner tube is configured to extend distally from the intermediate tube a second selected distance, thereby causing the distal end of the inner tube to be spaced apart from the distal end of the outer tube by a combination of up to the first and second selected distances.

In some embodiments of the endoscope, at least the portion of the endoscope extending distally from the handle is a disposable single use instrument supplied in sterile packaging.

In some embodiments, an intracranial endoscope comprises: an outer tube having opposite coupling and screwing ends; a middle tube, which is a rigid tube, that telescopes within the outer tube between an extended position and a retracted position, and a sleeve (12) that extends distally from the middle tube; a stopper at a distal end portion of the cannula distal to the coupling end of the outer tube and a biasing element biasing the stopper in a distal direction; an inner tube within a cannula, the inner tube shaped, sized and configured for insertion into a skull of a patient; a suction/irrigation tube within the inner tube configured to move between an extended position and a retracted position relative to the inner tube; an imaging module and an illumination module at a distal end of the inner tube, wherein the illumination module is configured to illuminate a field of view within the skull of the patient and the imaging module is configured to capture and supply images of the field of view for display to a user while the inner tube is inserted into the skull of the patient; a handle configured to be held by a user's hand and having a distal end portion coupled to the coupling end of the outer tube, and a proximal end portion, the handle comprising: a suction port coupler and an irrigation port coupler at a proximal portion of the handle; a user-operated suction and irrigation control configured to control flow between the suction/irrigation tube and the suction and irrigation port, respectively; and a user-operated extension-retraction control operatively associated with the suction/irrigation tube to control the extent to which the distal end of the suction/irrigation tube protrudes distally from the inner tube.

In some embodiments, the inner tube includes a tilt/bend portion adjacent its distal end, and the handle includes a tilt/bend controller operatively connected to the portion of the inner tube to control the angle of the distal end of the inner tube relative to a direction parallel to the axis of the outer tube. In some embodiments, the tilt/bend controller is configured to vary the angle in a single plane, and in some embodiments in two or more planes.

In some embodiments, the stopper includes a radially extending portion and a space that allows flow through the stopper.

In some embodiments, the suction/irrigation catheter has a distal end that is angled to form a tip.

A method of using the disclosed intracranial endoscope, the method comprising: providing an outer tube, an intermediate tube (rigid tube) telescoping within the outer tube between an extended position and a retracted position, a stopper distally spaced from the intermediate tube and biased in a distal direction, an inner tube within the intermediate tube and the stopper, the inner tube shaped, sized and configured for insertion into a skull of a patient, and a suction/irrigation tube within the inner tube configured to move relative to the inner tube between the extended position and the retracted position; inserting the distal portion of the inner tube into the skull of the patient through the opening prepared therein until the stopper is pressed against the skull or a surface associated with the skull of the patient; selectively inserting the inner tube further to prevent biasing of the stopper; selectively extending a distal end of the suction/irrigation tube distally from the inner tube; selectively applying suction and irrigation to the suction/irrigation tube at selected varying angles by a user control mechanically secured to a handle of the outer tube; selectively illuminating a field of view within the patient's skull with a light source at the distal end of the inner tube and imaging the field of view with a miniature camera at the distal end of the inner tube; and displaying the image photographed by the camera.

Drawings

Fig. 1a and 1b are side and top views, respectively, of an example of an endoscope.

Fig. 1c to 1e illustrate schematic diagrams of examples of valves controlling the suction/irrigation operation of examples of endoscopes.

Fig. 2a to 2d are partial views of the distal end portion of an endoscope that may be used in the endoscope of fig. 1a and 1b or in other examples of endoscopes.

Fig. 3a and 3b illustrate a schematic of an example of a mechanism for tilting/bending the distal tip of an endoscope example.

Fig. 4a, 4b and 4c illustrate schematic views of an example of a single button controlling both the extension/retraction of the suction/irrigation tube and the supply of suction/irrigation to the catheter according to the stroke of the finger operated button.

Fig. 4d and 4e illustrate schematic diagrams of examples of valve arrangements suitable for use in the mechanism of fig. 4a to 4 c.

FIG. 5 is a perspective view of an example of a handle of an endoscope and conduits for connecting to suction and irrigation sources.

Fig. 6a to 6c are perspective views of an example of an endoscope having a stopper with an opening for passing a material, such as cerebrospinal fluid, and fig. 6d and 6e illustrate schematic views of an alternative stopper.

Fig. 7a to 7c are perspective views of one example of the distal tip of an endoscope.

FIG. 8 is a perspective view of an alternative distal end of an endoscope.

Fig. 8a to 8c illustrate schematic views of alternative distal ends of endoscopes.

Fig. 9a and 9b illustrate schematic views of examples of endoscope handles.

Fig. 10a and 10b illustrate schematic views of alternative embodiments of portions of an intracranial endoscope.

FIG. 11 is a perspective view of an alternative embodiment of an intracranial endoscope.

Description of the main element symbols:

8. 8a, 708, 500a2, 500b2, 600a1, 600b2 suction/irrigation tube/catheter

10. 710 inner tube/catheter

10a inclined/curved portion

10b depth indicator scale

12 casing tube

14 external thread middle pipe/conduit

16 internal screw thread rigid outer tube/guide tube

18. 618k stopper

20 biasing element

700a thumb wheel controller

701. 702; 802. 803 lighting module

703. 801 imaging module

100. 500, 600, 700, 900, 1102 handle

1104. 1106 and 1108 controls

100a suction port coupler

100b flush port coupler

100a1, 100b1 corresponding sources of aspiration and irrigation materials

100c, 100d, 410, 418a, 418b, 418c, 502, 602, 900b, 900c, 900d aspiration and irrigation controllers

110. 910 Cable

112. 909 image display

114. 124 pipeline

116. 126, 418, 904 valve

118 cartridge

120 main cylinder

122. 907, 908 spring

200 vidicon

202 light source

201. 301, 501, 601, 901 tilt/bend controller

204. 208, 410, 412, 414, 416 extend-retract control

903 finger operated controller

905. 906 circuit board

300 suction source

310. 312 wire part

310a wheel

902 wheel/brightness control

804 projection

804a hollow pipe

600f conduit containing conducting wire

618a edge

618b spoke

618d, 618e wing

618f center part

618l central opening

Detailed Description

Fig. 1a and 1b illustrate one example of an endoscope, and fig. 2a to 2d illustrate a distal section that may be part of the endoscope of fig. 1a and 1b or an alternative endoscope design. The inner tube 10 projects in a distal direction from the sleeve 12 and further distally from the externally threaded intermediate tube 14. The catheter tube 14 in turn projects distally from the internally threaded rigid outer tube 16 and is screwed into the internally threaded rigid outer tube 16 from the screw-in end. The inner tube 10 has a bendable bend portion 10a near its distal end such that the distal end of the inner tube 10 points in a direction (and associated opposite direction) within an angular range from a common or parallel axis of the sleeve 12 and the

catheters

14 and 16. A depth indicator scale 10b (fig. 2c) extends a specified distance proximally from the distal tip of the catheter 10. A stopper 18 slides on the sleeve 12 between a distal position (fig. 2b) to which the stopper 18 is biased by a spring or other biasing element 20, and a position closer to or against the intermediate tube 14 (fig. 2 c). In use of the endoscope, the stopper 18 is typically pressed against the skull, or scalp, or nostrils, or outer ear of the patient, thereby providing stability and accuracy to the surgical procedure. The inner tube 10 surrounds the suction/irrigation tube 8 which slides within the catheter 10 between an extended position (fig. 2d), in which it projects distally from the inner tube 10, and a retracted position (fig. 2c), in which it does not project from the catheter 10 or minimally projects from the catheter 10. The distance of movement may be 3 to 30mm, but other distances may be designed as desired. The conduit 10 is typically made of metal, plastic, or a combination of metal and plastic and is rigid except for its curved or angled portion 10a, and the conduit 8 is typically made of a less rigid plastic material.

The distance that the intermediate tube 14 extends distally from the outer tube 16 is adjusted by rotating the two threaded tubes relative to each other, typically by rotating the guide tube 14 while holding the guide tube 16. The engaged threads operate to vary the distance in a range from a maximum (FIG. 1a) to a minimum (FIG. 1b), such as 70mm, although other ranges may be designed to meet specific endoscope requirements. In this example, the distance between the stop 18 and the distal end of the outer tube 16 is in the range of 100mm total (30 mm compression of the telescoping tube 14 into the catheter 16 plus biasing element 20 due to the screw penetration of 70 mm) and zero or near zero, although other ranges may be designed as desired. In practice, the conduit 14 protrudes from the conduit 16 and the conduit 10 protrudes from the sleeve 12.

The distal tip of the catheter 10 encloses an imaging module comprising a miniature camera 200 and an illumination source 202 comprising an LED lamp or fiber optic tip, which is indicated by the general location in fig. 2d and examples of which are described in more detail in fig. 7a, 7b and 8, which are described further below. The imaging and/or illumination module may be connected to a finger controller described below and an external display 112 by a cable 110 or wirelessly. The module may be powered through cable 110 from a power source, which may be included in display 112, and/or from an internal power source, such as a battery.

Fig. 1a and 1b also illustrate a handle 100 having a distal end coupled to the coupling end of the outer tube 16 and having a tilt/bend controller 201, in this example a roller, coupled to the tilt/bend portion 10a of the catheter 10 to tilt the distal tip of the catheter 10 and the distal portion of the catheter 8, which may protrude from the catheter 10, away from the axis of the catheter 10. At the proximal end of the handle 100, the handle 100 has couplers or

ports

100a and 100b to connect to respective sources of aspiration and irrigation material 100a1 and 100b1 through connecting tubes illustrated as dashed lines. The irrigation material may be saline or other fluid, and may contain a treatment substance, such as a drug, which may be in fluid form or solid form, e.g., a powder, gel, crystal, and other matrix that may be carried in a fluid stream. Under the control of a suction controller, such as button 100c, and a flush controller, such as button 100d, couplers or

ports

100a and 100b are connected to the suction/flush tube 8 through respective internal channels or conduits and valves (not shown in fig. 1a to 1 e). (in some other examples, a single controller for suction/irrigation may be used.) as button 100c is pushed progressively downward relative to the bias (by way of example illustrated in fig. 1 e), more suction is applied to catheter 8. When the button 100c is released, the fluid flow connection of the conduit 8 with the suction coupler or port 100a is closed (by way of example illustrated in fig. 1 d). When the flush button 100d is pushed against the bias (by way of example also illustrated in fig. 1 e), more flush material is supplied to the conduit 8, and when the button 100d is released, the fluid flow connection between the conduit 8 and the flush coupler 100b is closed (by way of example also illustrated in fig. 1 d). One or both of the couplers or

ports

100a and 100b may contain electrical wires and/or one or more optical fibers that connect external electronics and/or light sources to an imaging module, such as camera 200, and an illumination module, such as light source 202, at the tip of the catheter 10, or the handle 100 may contain respective separate electrical and/or fiber optic connectors (not shown) for that purpose. The handle 100 typically encloses circuitry involved in the operation of the camera 200 and/or the light source 202, such as a controller chip and other circuitry for operating the camera and light source, and the handle may have controls for turning on and off one or both of the camera and light source, or for selecting between a video clip and a photograph and/or for otherwise controlling hand or finger operation of the imaging and/or lighting module. Additionally, in this example, the handle 100 includes controls in the form of side slides 204 and 208 that slide in the distal-proximal direction to extend the catheter 8 distally from the tip of the catheter 10 (to the position seen in fig. 2d) or to retract the catheter into the catheter 10. The conduit 8 extension may be 5mm, but other ranges may be envisaged. Still further, the handle 100 may contain a controller in the form of a joystick or other interface associated with the catheter 8 to control the tilt of the extended portion of the catheter 8 (fig. 2d) relative to the axis of the catheter 10, the tilt control and tilt position of the tip of the catheter 8 not being shown in fig. 1a and 1b, but illustrated and discussed further below in connection with other figures.

Fig. 1c, 1d and 1e illustrate examples of fluid flow connections between couplers/

ports

100a and 100b and the distal portion of catheter 8 and valves for controlling fluid flow. As seen in the schematic in fig. 1c, the aspiration port 100a is connected to a conduit 124 controlled by a valve 126 operated by the button 100c, and the flush coupler/port 100b is connected to a conduit 114 controlled by a valve 116 operated by the flush button 100 d. The

conduits

124 and 114 merge into the distal portion of the catheter 8 (or into a conduit in fluid flow communication with the distal portion of the catheter 8), thereby enabling fluid flow between the distal portion of the catheter 8 and the couplers/

ports

100a and 100 b. Fig. 1d and 1e illustrate examples of valves that may be used for valve 112 and/or valve 114. In this example, the valve includes a moveable barrel 118 that slides within a main barrel 120 against the bias of a spring 122. Each cartridge has a transverse opening through which the conduit 124 (or 114) passes. The

conduits

124 and 114 are made of a material that is sufficiently pliable to compress, thus reducing or stopping fluid flow between the moveable and main cartridges when compressed, and sufficiently resilient to open, thus allowing flow between the two cartridges when not compressed. Spring 122 urges both cartridges to hold the valve closed, preventing fluid flow through conduit 124 (114). When the button 100a (100b) is pushed down to the position seen in fig. 1e, for example by the force of the spring 122 through the button 100c (100d), the two barrels are sufficiently separated to allow fluid to flow through the oval cross-section of the conduit 124 (114). Further downward pushing allows more flow until the conduit assumes a circular cross-section and pressure on the release button 100c (100d) gradually reduces the flow until the pressure is released sufficiently to allow the spring 122 to push the cartridge 118 upward enough from the main cartridge 120, as seen in fig. 1 d. Other examples of valves may be used to control fluid flow between the distal tip of the catheter 8 and the suction/irrigation ports, some of which are discussed further below.

For example, tilt/bend control of the distal tip of the catheter 10, and thus of the catheter 8, may be achieved by wires connected to diametrically opposite sides of the tip of the catheter 10 distal of the tilt/bend section 10 a. This can be controlled by twisting the knob 201, thereby shortening one of the two diametrically opposed wires, for example by a camming action. Another example is discussed in more detail below in conjunction with fig. 3a and 3 b.

Some or all of the portions of the handle distal end of the endoscope described in this patent specification may be single-use disposable components configured to be supplied in sterile packaging and assembled with one of the described handles, preferably manually and without tools, through the use of mating mechanical/electrical couplers to establish the required mechanical/electrical connections for the operations described in this patent specification. Alternatively, some or all of the endoscopes described in this patent specification may be disposable single-use devices that are used only once for a patient's procedure.

Fig. 3a and 3b illustrate an example of controlling the tilting/bending of the distal tip of the catheter 10 and thus of the catheter 8. The button 301 may be a sliding button or a joystick as schematically shown in fig. 3a and 3 b. The button may extend upward (not shown in the figures) from a wheel 310a mounted for rotation within the handle 100 through the top of the handle 100 and drive

wire portions

310 and 312 fixed to the top and bottom of the tip portion of the catheter 10 distal to the inclined/curved portion 10a and to the wheel 310a operated by the switch or joystick 301, respectively. Pulling the switch or joystick 301 backwards relative to the handle 100 tilts/bends the tip of the catheter 10 and thus the catheter 8 upwards, as seen in fig. 3b, and pushing the switch/joystick 301 forwards tilts/bends the tip of the

catheters

10 and 8 downwards. If another pair of wires (not shown) is used, such that its distal end is fixed to the tip of the catheter 10, then at each quarter of the tip of the catheter 10a wire is fixed, and a ball is fixed to the button/joystick 301 instead of the wheel 310a, where the wires are connected at the four sides of the ball, and then moving the button/joystick 301 sideways also tilts/bends the tips of the

catheters

10 and 8 to the left or right. Moving the intermediate direction of the button/joystick 301 relative to the handle 100 may effect tilting/bending of the tips of the

catheters

10 and 8 in any desired direction.

Fig. 4a, 4b and 4c illustrate examples of mechanisms for using a controller to control both the catheter 8 extending distally from the catheter 10 and suction/irrigation, which may be used inside one or more of the handles described in this specification, except that the button 410 may be accessed directly from outside the handle or through an intermediate button or lever. In this example, button 410 actuates a lever 412 which pivots at 414 inside the handle and has its other end (made of flexible material) fixed to catheter 8. Fig. 4a shows an intermediate position of the controller, in which the catheter 8 is in a retracted position relative to the catheter 10 and the spring 416 biases the lever 412 to that position (and curves upwardly along a portion of the catheter 8). When the button 410 is pushed into the handle against the bias of the spring 416, the lever 412 begins to push the catheter 8 in the distal direction. For a certain distance of initial travel of the button relative to the handle, for example the first 1.8mm of travel, the button 410 remains out of contact with the valve 418 such that the valve remains in its neutral position until the catheter 8 extends a selected distance, for example 1mm, from the catheter 10. In this position, as illustrated in fig. 4b, the degree of bending of the conduit 8 is slightly less than in fig. 4 a. As the button 410 is pushed further into the handle, still against the bias of the spring 416, the button contacts the valve 418 and acts on the valve as described below in connection with fig. 4d and 4e, thereby reducing and eventually stopping irrigation and beginning increased suction. At the same time, the lever pushes the catheter 8 to extend more, up to 3mm or 5.5mm, from the catheter 10 and the catheter 8 straightens, as illustrated in fig. 4 c. One benefit of the catheter 8 initially extending from the catheter 10 by the button 410 initially traveling down is that the surgeon can use the extended portion of the catheter 8 to poke and break up the clot without applying suction, and then press the button 410 further down to apply suction and extract the substance, which may contain broken and disintegrated material.

Fig. 4d and 4e illustrate an example of a valve 418 (also seen in fig. 4a to 4 c) that controls both aspiration and irrigation. The valve 418 includes a movable barrel 418a that slides within a main barrel 418 b. Aspiration tube 124 and irrigation tube 114 pass through corresponding openings in both barrels, but the openings are arranged such that when the openings of the aspiration tube are misaligned enough to compress aspiration tube 124 and prevent flow through the openings, the openings of the irrigation tube are aligned to not compress irrigation tube 114, thereby allowing irrigation material to flow to the distal end of catheter 8. Conversely, when the irrigation tube 114 is pinched to stop flow therethrough, the aspiration tube 124 is not pinched and allows aspiration from the distal end of the catheter 8. The spring 418c biases the two cartridges so that in the normal state of the valve 418, the irrigation tube 114 is open (not pinched), but the aspiration tube 124 is pinched and blocked. As the button 410 contacts the valve 418 and begins to move to the right in fig. 4d and 4e, the irrigation tube 114 becomes progressively more compressed as the aspiration tube 124 is progressively more open, causing the distal tip of the catheter 8 to progressively change from full irrigation and no aspiration to full aspiration and no irrigation. This arrangement facilitates irrigation of the anatomical site while the catheter 8 is retracted, followed by extension of the catheter 8 distally while still irrigated to facilitate removal of tissue to be cleared, followed by switching to suction to clear the tissue. Alternatively, the openings in the

barrels

418a and 418b may be aligned such that there is neither suction nor irrigation in the intermediate state of the valve 418, but irrigation or suction begins when the button 410 contacts the valve 418, and increases as the button is pushed further, then switching from one to the other of irrigation and suction.

Fig. 5 illustrates an example of a handle 500 that may be used with any of the components described herein extending distally from the handle, e.g., 100. At least for the layers on or near the outer surface of the portion of the handle 500 that the user's hand is holding, it may be made of a relatively soft material, such as rubber or a rubber-like material, to increase the user's comfort and be less likely to slip between the handle and the user's hand. The handle 500 as illustrated has a generally rectangular cross-section with curved edges, but contemplated generally triangular cross-sections with curved edges are alternatives. The handle 500 includes a suction/irrigation controller 502 which may take the form of a slider that operates valves that progressively open/close the fluid flow paths between the conduit 8 and conduit 500a2 to the suction source 300 and the conduit 500b2 to the irrigation material source. For example, as the user's thumb gradually pushes the slider 502 forward in the distal direction, suction is applied to the catheter 8 and the degree of suction increases as the distance the slider 502 is pushed in the distal direction increases. As the user pushes the slider 502 gradually backwards in the proximal direction, irrigation is supplied to the catheter 8 and then pushes the slider 502 more in the proximal direction, the irrigation flow gradually increasing. In this example, the slider 502 is biased to a neutral center position where neither suction nor irrigation is applied to the catheter 8, and returned to that position when the user does not push the slider 502 in either direction, and the alternative arrangement of the valve 418 described above may be used. The handle 500 also includes a joint control 501 coupled with the angled/curved portion 10a of the catheter 10 to articulate the distal end of the catheter 10 relative to the axis of the

catheters

14 and 16, for example, in a left-right direction, up-down direction, or any other direction.

Figures 6a, 6b and 6c illustrate perspective views of a stopper 618 as an important alternative to the stopper 18 of figures 1a to 2 d. The stopper 618 has openings through which excess cerebrospinal fluid can be expelled, and the openings can also avoid increasing intracranial pressure. In any of the examples of endoscopes discussed herein, stopper 618 may be used in place of stopper 18. The stopper 618 includes an arcuate or rounded edge 618a and three spokes 618b that extend distally when deployed from a cannula 618c secured to the cannula 12. In use, the stopper 618 is pressed against the skull or other head surface of the patient, as in the case of the stopper 18, while the distal tip of the endoscope is treating the material within the skull. The stopper 618 may also provide a navigation function, for example by making one or more of the spokes of the stopper longer or shorter than another spoke or other spokes, which may help control and assess the direction of insertion of the endoscope relative to the surface against which the stopper 618 is pressed, or by including other navigation aids that help identify the position and/or orientation of the portion of the catheter 10 within the skull during a surgical or exploratory procedure. The rim 618a and spokes 618b may be made of the same material, which may be sufficiently rigid to maintain shape during use of the endoscope, or the spokes and rim 618a may be made of materials having different stiffnesses or softness as desired or appropriate for different surgical or exploratory procedures. Fig. 6b and 6c illustrate a stopper 618 as part of an endoscope, having a handle 600 that may be identical to the handle 500 in fig. 5, and suction/irrigation conduits 600a1 and 600b2 that have the same function as the conduits 500a2 and 500b2 in fig. 5. Fig. 6b and 6c additionally illustrate a conduit 600f that may contain wires that supply power and/or carry control and image data to and/or from an imaging module containing a camera at the distal tip of an endoscope (not seen in fig. 6 a-6 c) and/or carry power, light or control signals to an illumination module containing a light source at the tip of an endoscope (also not seen in fig. 6 a-6 c).

Figures 6d and 6e illustrate an alternative stopper 618k that may be used in place of the stopper described above in any of the endoscopes described herein. The stop 618k includes a pair of

tabs

618d and 618e extending radially in opposite directions from a central portion 618f around the catheter 12. Each flap has a central opening 618l configured to allow fluid to flow therethrough when the stopper is pressed against the skull or other head surface of the patient. More than two tabs may be used in the alternative retainer, preferably evenly distributed around the circumference of the retainer. The illustrated tabs are triangular with a central opening and apex at the central region of the stopper, but other shapes are possible, such as ribbon, rectangle, and oval, to name a few. Preferably, the tab is made of a relatively soft material so that it does not damage the patient's tissue, but is sufficiently rigid and resilient so that the tab is spring-like when pressed against a surface.

Fig. 7a to 7b are perspective views of one example of the distal tip of an endoscope. Fig. 7a and 7b illustrate a distal end that may be used in any of the endoscopes described above. The distal end contains the forward (in the distal direction) parts of the imaging and illumination modules, i.e.

light sources

701 and 702, which may be LED lamps or fiber ends and a forward facing camera 703, e.g. a CMOS camera. An inner tube 10 surrounds the suction/irrigation tube 8 as well as the light source and camera. In one example of an endoscope, the outer diameter of the camera 703 may be 1.4mm, the outer diameter of the suction/irrigation tube 8 may be 2.8mm, the diameter of each of the optical fibers may be less than 0.4mm (or alternatively LEDs with comparable diameters may be used), and the outer diameter of the inner tube 10 may be 5.3 mm.

Fig. 7c illustrates an endoscope in which a catheter 710 for insertion into the skull of a patient extends distally 180mm from the handle 700 and a suction/irrigation tube 708 may extend distally up to 5mm from the catheter 710, as selected by the thumb wheel control 700 a.

Fig. 8 illustrates in perspective view an example of a distal tip that may be used with any of the endoscopes described herein. This example has an illumination module with forward looking

LED lights

802 and 803 and an imaging module with forward looking camera 801, and a protrusion 804, preferably transparent to light from the illumination module and extending in a distal direction from the inner tube 10. In addition, the illustrated tip may include a suction/irrigation tube (not explicitly shown in fig. 8) having a forward-looking opening and/or a lateral opening. For example, the catheter 8 may extend in a channel in the inner tube 10 and protrude distally from the catheter 10 as desired.

Fig. 8a to 8c illustrate alternative distal end portions that may be used in place of the distal end portions described above in any of the endoscopes described herein. The side views of fig. 8a and 8b show the distal end of the inner tube 10 from which the hollow tube 804a protrudes in the distal direction. The conduit 804a is preferably angled to the shape of a hypodermic needle and terminates in a sharp point. The side view of fig. 8b shows the distal portion 8a of the suction/irrigation tube 8 projecting distally from the hollow tube 804 a. Preferably, the distal end of the catheter portion 8a is also inclined like a hypodermic needle, with the sharp point preferably, but not necessarily, diametrically opposite the sharp point of the catheter 804 a. The front view of fig. 8c illustrates the arrangement of the elements in the inner tube 10: a hollow tube 804a and suction/irrigation tube portion 8a, an imaging module 801 and

light sources

802, 803. In use, after insertion of the inner tube into the skull of a patient, the angled tip of hollow tube 804a may assist in penetrating and/or disrupting tissue, such as coagulated blood, and the angled end of suction/irrigation portion 8a may then be extended distally to further compress the coagulated blood or other material and irrigate the sides or aspirate fluids or tissue.

Fig. 9a is a side view, and fig. 9b is a side view of an example of a handle 900 that may be used in any of the endoscopes in place of the handles described above. The handle 900 includes a tilt/flex control 901, as well as an irrigation control 900c in the form of a button and a suction control 900b in the form of a slider that control fluid flow between the suction/irrigation tube 8 (not seen in fig. 9a and 9 b) and the irrigation and

suction couplers

100b and 100a, respectively. In addition, the handle 900 includes brightness controls in the form of wheels 902 that the user can rotate to increase or decrease the brightness of the LEDs, such as 701, 702 in fig. 7a and 7b, or 802 and 803 in fig. 8. In addition, the handle 900 may contain one or more finger-operated controls 903 which control the video camera, e.g. 703 in fig. 7a and 7b or 801 in fig. 8, e.g. to turn the camera on and off, and/or to control other functions, e.g. to select between video clips and photos, or to select between different operating modes of the camera, e.g. different resolutions, frames per second, etc.

Fig. 9b illustrates some of the internal components of the handle 900, which may be the same or similar to those of other examples of handles described above. Fig. 9b illustrates valve 904 controlling fluid flow between suction/irrigation tube 8 (not seen in fig. 9 b) and suction and

irrigation couplers

100a and 100b, spring 907 biasing irrigation controller 900c to a position in which the irrigation controller closes the fluid flow connection between catheter 8 and tubing 100b, and spring 908 biasing suction control 900b to a position in which the suction control closes the fluid flow connection of catheter 8 and suction coupler 100 a. Additionally, fig. 9b illustrates an internal circuit board 905 (connected to the

LEDs

701, 702 or 802, 803 and the brightness control 902) for providing power and control to the LEDs, e.g., from an internal battery or from an external power source, which is connected to the external power source by a cable, e.g., 600f in the examples of fig. 6b and 6 c. Fig. 9b also illustrates a circuit board 906 that is coupled with a video camera at the distal tip of the endoscope, such as

camera

703 or 801, and is coupled to the controller 903 to provide power and control signals to the camera and carry images taken by the camera to an external display 909 through a cable 910 or through a wireless connection.

Figures 10a and 10b illustrate in perspective view the distal end portion of an endoscope using the stopper illustrated in figures 6d and 6e, and the distal end portion illustrated in figures 8a to 8 c. In fig. 10a, the suction/irrigation tube 8 (and its distal portion 8a) is retracted and not visible. In fig. 10b, the distal end portion 8a of the suction/irrigation tube 8 is shown protruding distally.

FIG. 11 shows, in perspective view, an example of an endoscope that uses the portions illustrated in FIGS. 10a and 10b, and that may use any of the features of other examples of endoscopes disclosed herein. FIG. 11 further illustrates a handle 1102 that may be used in place of other described handles in any of the endoscope examples disclosed herein. The handle contains

controls

1104, 1106 and 1108, which may take the form of slide switches, buttons, joysticks (or other user-operated controls) that can control the functions described above for other handles, e.g., extending and retracting the suction/irrigation tube 8, controlling the flow of suction and irrigation through the catheter 8 and its distal end portion 8a, tilting/bending the distal end portion of the inner tube 10, etc. Fig. 11 further illustrates two conduits coupled to the proximal portion of the handle 1102 and connected to suction and irrigation sources, as well as at least one cable for connecting the video module at the tip of the endoscope and the power source of the light source and connecting the video module to a video display screen and/or memory or other device to which photographs or video clips from the video module should be supplied.

While several embodiments are described, it should be understood that the novel subject matter described in this patent specification is not limited to any one embodiment or combination of embodiments described herein, but instead encompasses numerous alternatives, modifications, and equivalents. In addition, while numerous specific details are set forth in the following description in order to provide a thorough understanding, some embodiments may be practiced without some or all of these details. Moreover, for the purpose of clarity, certain technical material that is known in the related art has not been described in detail in order to avoid unnecessarily obscuring the new subject matter described herein. It should be clear that features of one or several of the specific embodiments described herein may be used in combination with features or other described embodiments. Further, like reference numerals in the various drawings indicate like elements.

Various modifications may be made without departing from the spirit and scope of the novel methods and systems described in this patent specification. Accordingly, the scope of the patent specification is not limited to the above-described embodiments, but is instead defined by the claims of the patent issuing thereon, in accordance with the full scope of equivalents thereof.

Claims

1. An intracranial endoscope, comprising:

an internally threaded rigid outer tube having opposite coupling and threading ends;

an externally threaded intermediate tube, which is a rigid tube, which is screwed into the outer tube from the screw-in end for relative rotation therewith, thereby telescoping between an extended position and a retracted position;

an inner tube having a proximal end portion partially within the intermediate tube and a distal end portion shaped, sized and configured for insertion into a skull of a patient;

a stopper mounted on a distal end of the intermediate tube distal to the coupling end of the outer tube for axial movement relative to the intermediate tube, and a biasing element biasing the stopper in a distal direction;

wherein the inner tube has a beveled/curved portion adjacent its distal end, and an extended position and a retracted position relative to the intermediate tube;

a suction/irrigation tube sliding in the inner tube between an extended position in which the suction/irrigation tube projects distally from the inner tube and a retracted position;

an illumination module and an imaging module at a distal end of the inner tube, wherein the illumination module is configured to illuminate a field of view within the skull of the patient and the imaging module is configured to capture and supply images of the field of view for display to a user;

a handle configured to be held by a user's hand and having a distal end portion coupled to the coupling end of the outer tube, and a proximal end portion, the handle including a suction port coupler and an irrigation port coupler at the proximal end portion of the handle, and user-operated controls to:

(i) one or more aspiration and irrigation controllers configured to control flow between the aspiration/irrigation tubing and aspiration and irrigation ports,

(ii) a tilt/bend controller operatively associated with the tilt/bend portion of the inner tube to control the direction and extent of tilt/bend thereof; and

(iii) an extension-retraction controller operatively associated with the suction/irrigation tube to control the extent to which the distal end of the suction/irrigation tube protrudes distally from the inner tube.

2. The intracranial endoscope as recited in claim 1, further comprising a hollow tube surrounding the distal end portion of the suction/irrigation tube and having a distal end that projects distally from the inner tube and is angled in the shape of a hypodermic needle.

3. The intracranial endoscope of claim 1, wherein the suction/irrigation tube has a distal end that is angled in the shape of a hypodermic needle.

4. The intracranial endoscope according to claim 1, further comprising a hollow projection from the distal end of the inner tube, the hollow projection having a pointed distal end that is inclined in the shape of a hypodermic needle, and wherein the suction/irrigation tube has a pointed distal end that is inclined in the shape of a hypodermic needle, and the two tips are diametrically opposed.

5. The intracranial endoscope as recited in claim 1, wherein the stopper comprises a rim configured to press against the patient's skull or other head surface while the inner tube extends into the patient's skull a distance limited at least in part by the position of the stopper relative to the inner tube.

6. The intracranial endoscope as in claim 1, wherein the stopper comprises two or more tabs extending radially from a central region thereof, the tabs being configured to press against the skull or other head surface of the patient while the inner tube extends into the skull of the patient a distance limited at least in part by the position of the stopper relative to the inner tube.

7. The intracranial endoscope as in claim 1, wherein the stopper comprises an opening configured to allow cerebrospinal fluid to flow through the opening while the stopper is pressed against a patient's skull or other head surface and the inner tube is inserted into the patient's skull.

8. The intracranial endoscope of claim 1, wherein the one or more suction and irrigation controls comprise one or more user-operated buttons configured to move between positions that control flow into or out of the distal tip of the suction/irrigation tube.

9. The intracranial endoscope of claim 1, wherein the one or more suction and irrigation controllers comprise a single switch that moves in one direction to connect the suction/irrigation tube to a source of suction and in another direction to connect the suction/irrigation tube to a source of irrigation material.

10. The intracranial endoscope as recited in claim 1, wherein the tilt/bend controller comprises a thumb-operated joystick.

11. The intracranial endoscope of claim 1, wherein the tilt/bend controller is configured to tilt/bend the distal end portion of the inner tube in at least two directions relative to the longitudinal axis of the outer tube.

12. The intracranial endoscope of claim 1, wherein the imaging module comprises a control circuit housed in the handle.

13. The intracranial endoscope as recited in claim 1, further comprising a display operatively associated with the imaging module to display intracranial images taken therethrough.

14. The intracranial endoscope of claim 1, wherein the outer tube and intermediate tube are configured for telescoping the intermediate tube distally from the outer tube within a first selected distance range, and the inner tube is configured to extend distally from the intermediate tube a second selected distance, thereby causing the distal end of the inner tube to be spaced from the distal end of the outer tube by a combination of up to the first and second selected distances.

15. The intracranial endoscope according to claim 1, wherein at least the portion of the intracranial endoscope extending distally from the handle is a disposable single-use instrument supplied in sterile packaging.

16. An intracranial endoscope, comprising:

an outer tube having opposite coupling and screwing ends;

a middle tube that is a rigid tube that telescopes within the outer tube between an extended position and a retracted position, and a sleeve that extends distally from the middle tube;

a stopper at a distal portion of the cannula distal to the coupling end of the outer tube, and a biasing element biasing the stopper in a distal direction;

an inner tube within the cannula, the inner tube shaped, sized and configured for insertion into a skull of a patient;

a suction/irrigation tube within the inner tube configured to move between an extended position and a retracted position relative to the inner tube;

an imaging module and an illumination module at a distal end of the inner tube, wherein the illumination module is configured to illuminate a field of view within the skull of the patient and the imaging module is configured to capture and supply images of the field of view for display to a user while the inner tube is inserted into the skull of the patient;

a handle configured to be held by a user's hand and having a distal end portion coupled to the coupling end of the outer tube, and a proximal end portion, the handle comprising:

(i) a suction port coupler and an irrigation port coupler at a proximal portion of the handle,

(ii) a user-operated suction and irrigation control configured to control flow between the suction/irrigation tube and suction and irrigation ports, respectively, an

(iii) A user-operated extension-retraction control operably associated with the suction/irrigation tube to control the extent to which the distal end of the suction/irrigation tube protrudes distally from the inner tube.

17. The intracranial endoscope of claim 16, wherein the inner tube includes a tilt/bend portion adjacent its distal end, and the handle includes a tilt/bend controller operatively connected to the portion of the inner tube to control the angle of the distal end of the inner tube relative to a direction parallel to the axis of the outer tube.

18. The intracranial endoscope as recited in claim 17, wherein the tilt/bend controller is configured to change the angle in a single plane.

19. The intracranial endoscope as recited in claim 17, wherein the tilt/bend controller is configured to change the angle in multiple planes.

20. The intracranial endoscope as recited in claim 16, wherein the stopper comprises a radially extending portion and a space that allows flow through the stopper.

21. The intracranial endoscope as recited in claim 16, wherein the suction/irrigation tube has a distal end that is angled to form a tip.