Endoscopic System With Attached Instruments

Abstract

An endoscopic system having a shaft, a sheath disposed at least partially inside the shaft having a distal end with a leading surface and an inner surface, the leading surface at the distal end of the sheath having rounded edges so as to be atraumatic, an instrument at least partially inside the sheath and movable relative to the sheath along a longitudinal direction of the sheath, the inner surface being sloped so as to deflect the instrument at a predetermined angle as it is moved into contact with the inner surface and out of the sheath, and the sheath being rotatable relative to the shaft so as to change the direction at which the instrument extends from the sheath.

Claims

1. An endoscopic system comprising: a shaft; a sheath disposed at least partially inside the shaft having a distal end with a leading surface and an inner surface; the leading surface at the distal end of the sheath having rounded edges so as to be atraumatic; an instrument at least partially inside the sheath and movable relative to the sheath along a longitudinal direction of the sheath; the inner surface being sloped so as to deflect the instrument at a predetermined angle as it is moved into contact with the inner surface and out of the sheath; the sheath being rotatable relative to the shaft so as to change the direction at which the instrument extends from the sheath.

2. The endoscopic system of claim 1, further comprising a handle disposed at a proximal end of the shaft, the handle having a slidable and locking knob for extending the instrument out of the sheath or retracting the instrument into the sheath.

3. The endoscopic system of claim 2, further comprising a symbol on the handle for providing an indication of whether the instrument is extended or retracted.

4. The endoscopic system of claim 2, wherein the knob may lock the instrument into multiple different extended positions.

5. The endoscopic system of claim 1, wherein the predetermined angle is any angle from about zero degrees to about 90 degrees.

6. The endoscopic system of claim 1, wherein the instrument is a cannula or a needle.

7. The endoscopic system of claim 1, wherein the instrument is a wire, a laser fiber, a guide wire, a sheath, or other endoscopic tool.

8. The endoscopic system of claim 1, further comprising a light source for providing light to the instrument, the instrument being a laser fiber.

9. The endoscopic system of claim 1, the sheath having a proximal end connectable to external devices while permitting straight through passage of the instrument.

10. The endoscopic system of claim 1, the sheath being made of at least one of metals, plastics, and shape memory alloys, including nitinol.

11. The endoscopic system of claim 1, the instrument being made of at least one of metals, plastics, and shape memory alloys, including nitinol.

12. The endoscopic system of claim 1, the sheath and the instrument being sized such that the instrument extends to a predetermined maximum distance out of the distal end of the sheath.

13. The endoscopic system of claim 1, the sheath being rotatably connected to a mating endoscopic channel via a Luer fitting.

14. The endoscopic system of claim 1, further comprising a symbol on a handle for providing an indication of the rotational position of the sheath.

15. The endoscopic system of claim 1, the sheath being sized such that the sheath and instrument extends a predetermined maximum distance out of the distal end of the endoscope.

16. The endoscopic system of claim 1, the sheath having a proximal end connectable to an external device.

17. The endoscopic system of claim 16, wherein the external device is a fluid.

18. An endoscopic system comprising: a shaft; an imaging device disposed at a distal end of the shaft; a light source providing light to the distal end of the shaft; a sheath disposed at least partially inside the shaft having a distal end with a leading surface and an inner surface; the leading surface at the distal end of the sheath having rounded edges so as to be atraumatic; an instrument at least partially inside the sheath and movable relative to the sheath along a longitudinal direction of the sheath; the inner surface being sloped so as to deflect the instrument at a predetermined angle as it is moved into contact with the inner surface and out of the sheath; the sheath being rotatable relative to the endoscope so as to change the direction at which the instrument extends from the sheath; a handle disposed at a proximal end of the shaft, the handle having a slidable and locking knob for at least one position of extending the instrument out of the sheath and retracting the instrument into the sheath.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] FIG. 1a is a section, side view of the endoscopic system with a needle in an extended position.

[0033] FIG. 1b is a top view of the endoscopic system with a needle in an extended position.

[0034] FIG. 2a is a section, side view of the endoscopic system with a needle in a retracted position.

[0035] FIG. 2b is a top view of the endoscopic system with a needle in a retracted position.

[0036] FIG. 3 is a side view of the endoscopic system with a needle in a retracted position.

[0037] FIG. 4 is a side view of the endoscopic system with a needle in an extended position.

[0038] FIG. 5a is a side view of the distal end section of the endoscopic system with a needle in an extended position.

[0039] FIG. 5b is a top view of the distal end section of the endoscopic system with a needle in an extended position.

[0040] FIG. 6 is an isometric view of the endoscopic system with a needle in an extended position.

[0041] FIG. 7 is an isometric view of the endoscopic system with a needle in an extended position and an attached endoscope.

[0042] FIG. 8a is a section, side view of the endoscopic system with a cable in an extended position.

[0043] FIG. 8b is a top view of the endoscopic system with a cable in an extended position.

[0044] FIG. 9 is an isometric view of the endoscopic system with a cable in an extended position.

[0045] FIG. 10a is a side view of a distal end of the endoscopic system with a cable in an extended position.

[0046] FIG. 10b is a top view of the distal end of the endoscopic system with the cable in an extended position.

[0047] FIG. 11 is a side view of the endoscopic system with an attached endoscope.

[0048] FIG. 12 is an isometric view of a distal end of the endoscopic system with an attached endoscope.

[0049] FIG. 13a is an isometric view of the endoscopic system.

[0050] FIG. 13b is a side view of the endoscopic system.

[0051] FIG. 14a is a section, side view of the endoscopic system with a needle extended.

[0052] FIG. 14b is a top view of the endoscopic system with a needle extended.

DETAILED DESCRIPTION

[0053] An endoscopic system is shown in FIGS. 1a-7. The endoscopic system and components used therewith are preferably disposable for hygienic reasons.

[0054] An instrument 1, such as a sharpened hollow metal cannula or needle 1, is disposed within a protective sheath 2 of suitable length to pass through an endoscope (such as the one shown in FIG. 7) working channel and exit the distal end of the endoscope. The hollow cannula or needle 1 (hereinafter referred to as a cannula 1 or a needle 1) may be constructed of various metals, including shape memory allows (such as Nitinol) to facilitate curvature when the needle 1 is extended. The needle 1 may be fabricated as pre-bent if desired. The needle 1 and/or sheath 2 may also be plated with a radio-opaque material (such as gold) to enhance visibility when used with X-Ray equipment. The needle 1 and sheath 2 may be of various diameters. The needle 1 may permit passage of both fluids and mechanical devices and instruments. The sheath may be a solid tube or a wound spring of various constructions to facilitate bending and passage through various types of endoscope lumens, including those found in flexible endoscopes. The needle 1 and sheath 2 may be of various lengths to accommodate different endoscopes but should be specifically designed to provide exact protrusion of the device from the distal end of said endoscope.

[0055] The needle 1 may also be a different instrument or device, such as a laser fiber or a guide wire.

[0056] The needle 1 tip may be cut in any plane, some planes providing advantageous entry to the anatomy and others providing optimum protection to the sharp tip when exiting the cannula. Some planes providing both advantages.

[0057] The needle 1 is capable of axial motion along axis 3 within the sheath 2. The needle 1 is designed to specifically interface with a cannulated endoscope. This interface is controlled by the connection type (in this case a rotationally adjustable Luer lock fitting 11 and the precise length of the needle 1 and sheath 2 such that protrusion from the distal end of the endoscope is controlled. A rotationally adjustable ring 17 may be used to control the extension of the needle or hollow cannula 1. When extended, the needle 1, in conjunction with the adjacent atraumatic tip 4, may form a “V” shaped distal configuration 26. In this configuration, the atraumatic tip 4 providing a natural barrier or “stop” to excessive tissue penetration by the needle 1.

[0058] The sheath 2 has an atraumatic distal end 4 to prevent patient injury. In addition, the sheath 2 has an elevator or ramp 5 disposed at its distal end, providing an oblique exit out of the sheath 2. The elevator 5 may be configurable to have different exit angles, including any angle between 0 and 90 degrees, inclusive. The elevator 5 may be of various shapes and sizes to direct the needle in the optimal direction.

[0059] The needle 1 and sheath 2 are proximally attached to an actuator body 6. The actuator body 6 may be constructed of various materials, metals or plastics and may be produced by injection molding, machining, or additive manufacturing processes. The actuator body 6 includes a proximal knob 14 attached to a slidably locking piston 7 that enables axial motion 3 of the needle 1. The slidably locking piston 7 may have various linear travel limits to provide optimal extension of the needle 1. Additionally, the slidably locking piston 7 may have multiple locking points to provide various extensions of the needle 1 within the same device. For example, the slidably locking piston 7 can be locked in two or more positions (e.g., 8a-8d) that fix the digital extension of the needle in selectable increments. A visual indicator may be placed on the slidably locking piston 7 to disclose the axial position of the needle 1. For example, a red visual indicator may be placed at location 13 and a green visual indicator can be placed at location 9. Then, as the needle 1 is either in the “safe” or “extended” positions, the appropriate visual indicator will be shown to the operator (compare FIGS. 1a, 2a). Any known visual indicators, such as letters, symbols, signs, colors, etc. can be used. If the needle 1 is not locked in a position by the slidably locking piston 7, a spring mechanism 10 can return the needle 1 to the “safe” position. A button 15 may also be connected to the spring mechanism to return the need to the “safe” position when pressed.

[0060] The actuator body 6 may be connected to the channel fitting (Luer) 11 of an endoscope. This connection being rotationally adjustable. Indicia 16 at the rotationally adjustable connection 11 can show degrees of angular rotation of the distal end, and thus the direction of the needle 1. For example, degree markings may be placed in 90-degree increments or 45-degree increments. Any known visual indicators, such as letters, symbols, signs, colors, etc. can be used.

[0061] The needle 1 inner diameter may be connected to an external syringe or fluid delivery system via connection 12, which may be a Luer connection. The Luer connection may be with “T” style Luer fittings which allow straight through passage of other devices. The connection 12 of the needle 1 inner diameter may also allow for passage of ancillary instruments such as guidewires, etc. to the target organ.

[0062] In operation, the device is removed from sterile packaging, checked to assure that it is in “safe” mode with the needle 1 retracted and green indicator ring 9 showing, and inserted into the proximal endoscope working channel. It is then passed through the channel until the Luer Lock fittings 11 meet and are engaged. The device is then connected to the delivery mechanism for the therapeutic media or instruments via a proximal Luer fitting 12. At this point, the device is ready to use.

[0063] Due to the length of the device (typically 200 mm or greater) It may be advantageous to “prime” the needle 1. This is accomplished by filling the needle 1 with media and observing the exit of said media via the distal end.

[0064] During an endoscopic procedure, the needle 1 extension length is selected by the user via a rotationally adjustable ring 17 located on the actuator body 6. The needle 1 may be extended via a proximal knob 14 attached to piston 7 that employs a “push to lock” linear motion. When in the extended position a red indicator ring 13 will show on the device as a warning. The needle 1 may be retracted by operating a spring-loaded button mechanism 15 placed on the control handle actuator body. This retraction may be assisted by an internal compression spring 10 as a safety device. When in the retracted position a green indicator ring 9 will show on the device as an indicator of “safe” mode. Multiple extensions and retractions are possible. The needle should be retracted and confirmed in “safe” mode before withdrawal of the needle or endoscope from the patient.

[0065] Depending on the configuration of the distal end of the device, the needle 1 may exit axially (i.e. no “elevator”) or at any oblique angle (such as those between 0 and 90 degrees, inclusive) as provided by numerous elevator designs 5. The oblique angle of exit enabling injection of therapeutics into lumen walls off the axis of the endoscope, ideally within the center of the field of view, or in radial patterns about the axis of the endoscope, all having benefits for specific conditions. Additionally, the device may be used extraluminally, under the direct visualization of the parent endoscope to access vessels or organs enabling the introduction of therapeutics and/or devices.

[0066] In FIGS. 8a-10b, the endoscopic system is shown. In this system, the instrument 1 may be a flexible laser fiber 1 or other devices. The laser fiber 1 and the sheath 2 may be of a fixed length 18. As shown in FIGS. 8a-10b, not all features shown in FIGS. 1a-7 are present, depending on the device being used and the particular safety and control requirements.

[0067] Here, the laser fiber 1 is designed specifically to interface with a cannulated endoscope. This interface is controlled by the connection type (in this case a Luer lock fitting 11) and the precise length of the laser fiber and sheath such that, when engaged, the laser fiber's protrusion from the distal end of the endoscope is fixed in length and controllable rotationally. In operation, the device is removed from sterile packaging and the sheath 2 is inserted into the proximal endoscope working channel. It is then passed through the channel until the Luer Lock fittings 11 meet and are engaged. At this point, the device is ready to use.

[0068] During the endoscopic procedure, a flexible laser fiber 1 (or another device such as a guide wire, cannula, etc.) is passed through the proximal Luer fitting 12 and exits the distal end at an oblique angle. This angle being adjustable by the design of the elevator 5 at the distal end. The radial position of distal exit may be adjusted by the user via rotation of the proximal control body 6 with visual indicia 16 of said rotational position. The fiber 1 may be retracted within the sheath for repositioning of the endoscope or at the conclusion of the procedure. Depending on the configuration of the distal end of the device, the fiber 1 or other instrument may exit axially (i.e. no elevator 5) or at any oblique angle (such as those between 0 and 90 degrees, inclusive) as provided by numerous elevator designs 5. The oblique angle of exit enabling therapies off the axis of the endoscope, ideally within the center of the field of view, or in radial patterns, all having benefits for specific conditions.

[0069] FIGS. 11-14b also show the endoscopic system. The endoscopic system may have an endoscope 21, which may be flexible, semi-rigid, or rigid. The endoscope 21 may have one or more working channels 22. The endoscope may have an electronic imaging device 23, such as a CMOS imager, which may be disposed at the distal end. Alternatively, the electronic imaging device 23 may be at the proximal end, with a cable leading to the proximal end where the image is acquired. In either case, the electronic imaging device may have a camera control unit. Power in and signal output may be provided via an umbilical 25 that may be integral or removable.

[0070] Instruments 1 are provided to the system that attach directly to the proximal port of the working channel 22 and provide the user certain features and control. For example, as discussed above, proximal knob 14 may control instrument extension and rotation. Luer lock fitting 11 and actuator body 6 may control instrument rotation. Fluid, biologics, and coaxial devices may be introduced through fitting 12. An atraumatic distal end 4 may prevent patient injury and protect the endoscope working channel. In addition, an elevator 5 at the distal end may provide oblique deflection of coaxially passed instrument.

[0071] In FIGS. 11-14, an instrument 1 is depicted as a cannula, which provides for fluid or media injection. The cannula and its sheath 2 are proximally attached to the actuator body 6. As discussed above, the axial motion 3 of the cannula can be controlled by a slidably locking piston 7, which may be locked in two or more positions 8a and 8b. A visual indication 9, 13 of the position may be provided, as discussed above. The cannula 1 may be configured to automatically retract via a spring mechanism 10 and a button 15. The actuator body 6 may be connected to the endoscope 21 via a channel fitting 11 (Luer) and may be rotationally adjustable. The connection of the cannula inner diameter to a fluid delivery system may be provided by a connection 12. The connection 12 may also allow for the passage of additional instruments (e.g., a guidewire) to the target organ.

[0072] The endoscopic system is designed to address the issues of access to the anatomy and precise control of ancillary instruments for application of numerous therapies. A key to the system is an attachable series of instruments meant to pass through the endoscope working channel. The interface between the endoscope and the instrument is fixed via a Luer Lock or similar connection. The connected instrument has adjustments and mechanics that provide rotation, linear motion, oblique distal exit control, passage of additional fluids and devices, as well as application of energy (Laser, HF, Cryo, etc.). The precise length of the devices may be matched to the endoscope length such that protrusion from the distal end of the endoscope is controlled.

[0073] In operation, the endoscopic system is removed from sterile packaging, attached to any ancillary power and control devices, and checked for function. The instrument 1 is removed from sterile packaging checked to assure that it is in “safe” mode (if applicable) and inserted into the proximal endoscope working channel. The instrument shaft is then passed through the working channel until the Luer Lock fittings meet and are engaged. The instrument is then connected to the delivery mechanism for the therapeutic media via a proximal Luer fitting. The endoscopic system is now prepared for use.

[0074] In one example, during the endoscopic procedure the instrument 1 may be extended via a proximal knob that employs a “push to lock” linear motion. When in the extended position a red indicator ring 13, for example, will show on the device as a warning. The instrument 1 may be retracted by operating a spring-loaded button mechanism 15 on the control handle, said retraction being assisted by an internal compression spring 10 as a safety device. When in the retracted position a green indicator ring 9, for example, will show on the device as an indication of “safe” mode. Multiple extensions and retractions are possible. The instrument 1 is then retracted and confirmed in “safe” mode before withdrawal of the instrument or endoscope from the patient. Multiple types of instruments 1 may be installed and employed during the surgery.

[0075] Depending on the configuration of the distal tip, the instrument may exit axially (i.e. no “elevator”) or at any oblique angle (such as those between 0 and 90 degrees, inclusive) as provided by numerous elevator designs 5. The oblique angle of exit enabling delivery of therapeutics into lumen walls or organs off the axis of the endoscope, or in radial patterns about the axis of the endoscope, all such actions having benefits for specific conditions. Additionally, the instrument 1 may be used extraluminally, under the direct visualization of the parent endoscope to access vessels or organs enabling the introduction of therapeutics and/or devices.

[0076] In compliance with the statute, the present teachings have been described in language more or less specific as to structural and methodical features. It is to be understood, however, that the present teachings are not limited to the specific features shown and described, since the systems and methods herein disclosed comprise preferred forms of putting the present teachings into effect.

[0077] For purposes of explanation and not limitation, specific details are set forth such as particular architectures, interfaces, techniques, etc. in order to provide a thorough understanding. In other instances, detailed descriptions of well-known devices, circuits, and methods are omitted so as not to obscure the description with unnecessary detail.

[0078] Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to a/an/the element, apparatus, component, means, step, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, component, means, step, etc., unless explicitly stated otherwise. The steps of any method disclosed herein do not have to be performed in the exact order disclosed, unless explicitly stated. The use of “first”, “second,” etc. for different features/components of the present disclosure are only intended to distinguish the features/components from other similar features/components and not to impart any order or hierarchy to the features/components.

[0079] To aid the Patent Office and any readers of any patent issued on this application in interpreting the claims appended hereto, Applicant that it does not intend any of the claims or claim elements to invoke 35 U.S.C. 112(f) unless the words “means for” or “step for” are explicitly used in the particular claim.

[0080] While the present teachings have been described above in terms of specific embodiments, it is to be understood that they are not limited to these disclosed embodiments. Many modifications and other embodiments will come to mind to those skilled in the art to which this pertains, and which are intended to be and are covered by both this disclosure and the appended claims. It is intended that the scope of the present teachings should be determined by proper interpretation and construction of the appended claims and their legal equivalents, as understood by those of skill in the art relying upon the disclosure in this specification and the attached drawings.