CN118119326A

CN118119326A - Modular endoscopic imaging guidewire system and method

Info

Publication number: CN118119326A
Application number: CN202280069896.1A
Authority: CN
Inventors: N·M·马尔德斯瓦尔
Original assignee: Gyrus ACMI Inc
Current assignee: Gyrus ACMI Inc
Priority date: 2021-10-22
Filing date: 2022-10-14
Publication date: 2024-05-31

Abstract

A modular endoscope system, the modular endoscope system comprising: an imaging guidewire comprising an elongate shaft extending from a proximal end to a distal end, an imaging device positioned near the distal end of the elongate shaft, and an illumination element positioned near the distal end of the elongate shaft; and an intervention accessory configured to slide along the elongate shaft to provide a medical intervention. A method of providing medical intervention to an internal anatomical location, the method comprising: inserting an imaging guidewire into the anatomic passageway; using the imaging function of the imaging guidewire to view the target anatomy; pushing the intervention accessory along the imaging guidewire to the target anatomy; and operating the intervention accessory to provide an intervention to the target anatomy.

Description

Modular endoscopic imaging guidewire system and method

Cross reference to related applications

The present application claims priority from U.S. provisional patent application No. 63/26262899 filed on 22 nd 10 months 2021 and U.S. provisional patent application No.63/267616 filed on 7 nd 2 years 2022, the contents of which are incorporated herein by reference.

Technical Field

The present disclosure relates generally to medical devices and instruments configured to provide diagnostic and therapeutic procedures. More particularly, the present disclosure relates to medical device systems that include an elongate body that can be inserted into an incision or opening in a patient's anatomy and then advanced to a deeper location within the patient's anatomic passageway where diagnostic and therapeutic operations can be performed.

Background

The endoscope may be used in one or more of the following aspects, namely: 1) Providing access to other devices (e.g., treatment devices or tissue collection devices) toward various anatomical portions; and 2) imaging the anatomical portions. Such anatomical portions may include the gastrointestinal tract (e.g., esophagus, stomach, duodenum, cholangiopancreatic duct, intestine, colon, etc.), kidney regions (e.g., kidneys, ureters, bladder, urethra), and other internal organs (e.g., reproductive system, sinus cavities, submucosal regions, respiratory tract), etc.

Conventional endoscopes may involve a variety of clinical procedures, including: such as illuminating, imaging, detecting, and diagnosing one or more disease states; providing fluid delivery to the anatomical region (e.g., saline or other formulation via a fluid channel); providing a channel (e.g., via a working channel) for one or more medical devices for sampling or treating an anatomical region; and provides a suction channel or the like for collecting fluid (e.g., saline or other formulation).

In conventional endoscopes, the distal portion of the endoscope may be configured to support and orient another instrument, such as via a steering device and using a lifter. In some systems, two endoscopes may be configured to work together, wherein a first endoscope guides a second endoscope inserted into the first endoscope by means of a lifter capable of rotating the second endoscope relative to the first endoscope. Such a system may help guide the endoscope to difficult to reach anatomical locations within the body. For example, some anatomical locations can only be accessed using an endoscope after traversing a circuitous path that sometimes makes sharp turns between different anatomical passageways.

One example of an endoscopic procedure is known as endoscopic retrograde cholangiopancreatography, hereinafter referred to as "ERCP" procedure. In ERCP surgery, an "auxiliary scope" (also known as a son scope or choledochoscope) may be attached and advanced through the working channel of a "main scope" (also known as a mother scope or duodenoscope). Once the auxiliary mirror has reached the desired position, various procedures can be performed, sometimes requiring the use of additional instruments or devices. For example, a tissue retrieval device inserted through the auxiliary mirror may be used to remove sample material, or a guidewire may be inserted through the auxiliary mirror to place the stent.

Disclosure of Invention

The present inventors have recognized that problems addressed with conventional medical devices, particularly endoscopes and duodenoscopes for diagnosing and treating anatomical structures, include: wherein 1) it is difficult to fully evaluate anatomy and determine intervention strategies after a scope such as a choledochoscope positioned via a duodenoscope has been placed; 2) Different instruments are used to perform different types of surgery at the same anatomical location; and 3) practitioners are reluctant to use alternative medical device systems having different functions than the practitioner is accustomed to. In the case of 1), it is sometimes necessary to take a tissue sample in order to take a biopsy before the diseased tissue can be removed, thus requiring a subsequent operation. In the case of 2), sometimes the stone removal procedure may involve a different accessory for use with the duodenal mirror than the tissue sampling procedure. In the case of 3), gastroenterologists may be classified as being able to perform a limited type and number of procedures if they cannot accommodate the operation of a wide variety of devices and instruments.

The present disclosure may help provide solutions to these and other problems by providing systems, devices, and methods that can perform a number of different procedures using features familiar to a wide range of surgeons. The present disclosure includes various modular endoscope systems that provide a surgeon with a variety of contexts with familiarity to perform surgery using a first instrument having readable and useable features. Thereafter, a second instrument may be used in combination with the first instrument to provide desired interventional results, such as diagnostic procedures, tissue removal procedures, or implantation procedures, using techniques and features specific to such procedures that are familiar to different surgeons. In an example, the first instrument may include an imaging guidewire and the second instrument may include one of a plurality of accessories configured to be attached to or slid along the imaging guidewire. The imaging guidewire may have camera and illumination capabilities as well as a small diameter to facilitate navigation to a desired anatomical location. The camera function may be used to evaluate the anatomy and then the shaft of the imaging guidewire may be used to guide the selected attachment to the anatomical location without requiring separate guidance to perform the desired procedure.

In an example, a modular endoscope system may include an imaging guidewire including an elongate shaft extending from a proximal end to a distal end, an imaging device positioned near the distal end of the elongate shaft, and an illumination element positioned near the distal end of the elongate shaft, and an intervention accessory configured to slide along the elongate shaft to provide a medical intervention.

In another example, a method of providing medical intervention to an internal anatomical location may include: inserting an imaging guidewire into the anatomic passageway; using the imaging function of the imaging guidewire to view a target anatomy; pushing an intervention accessory along the imaging guidewire to the target anatomy; and operating the intervention accessory to provide intervention to the target anatomy.

Drawings

FIG. 1 is a schematic view of a modular endoscope system including an imaging guidewire and an accessory configured to sit astride the imaging guidewire, the accessory including a concentrically mounted accessory and an undermounted accessory.

Fig. 2A is a schematic view of the exterior arrangement of the concentrically mounted accessory of fig. 1 around an imaging guidewire.

Fig. 2B is a schematic view of the attachment of the fig. 1 mounted underneath to a bottom portion of an imaging guidewire.

Fig. 3 is a schematic diagram of an endoscope system including a duodenal mirror and an imaging and control system including a control unit coupled to the duodenal mirror.

Fig. 4 is a schematic illustration of the imaging and control system of fig. 3 coupled to a duodenal mirror.

Fig. 5A is a schematic top view of a camera module including an optical component and a lifting mechanism for a side view endoscope.

Fig. 5B is an enlarged cross-sectional view taken along plane 5B-5B of fig. 5A, showing the optical component.

Fig. 5C is an enlarged cross-sectional view taken along plane 5C-5C of fig. 5A, showing the lift mechanism.

Fig. 6 is a schematic diagram illustrating the duodenoscope of fig. 3-5C with the imaging guidewire of fig. 1-2B positioned in the common bile duct of the duodenum.

Fig. 7A and 7B are schematic illustrations of the concentrically mounted accessory of fig. 1 and 2A including a stent mounted to an imaging guidewire in collapsed and expanded states, respectively.

Fig. 7C is a schematic view of the duodenum of fig. 6 with the stent of fig. 7A and 7B inserted into the duodenal papilla of the common bile duct.

Fig. 8 is a close-up schematic view of a rail system used to connect the undermount accessory of fig. 1 and 2B, including a working channel and an auxiliary channel.

Fig. 9 is a schematic view of a modular endoscopic quasi-mirror system including an imaging guidewire attached to an accessory module having a fluid channel and an integrated laser fiber.

Fig. 10 is a schematic view of a modular endoscope system including an imaging guidewire attached to an accessory module having a fluid channel and a working channel into which a removal device is inserted.

FIG. 11 is a schematic view of a modular endoscope system including an imaging guidewire extending through an accessory module having a fluid channel and a working channel into which a removal device is inserted.

Detailed Description

Fig. 1 is a schematic view of a modular endoscope system 100 that includes an imaging guidewire 102 and accessories configured to sit astride the imaging guidewire, including concentrically mounted accessories 104 and an undermounted accessory 106. Fig. 1 is not necessarily drawn to scale and may be exaggerated in some aspects for illustrative purposes.

The system 100 can include an imaging guidewire 102, a concentrically mounted accessory 104, and an undermount accessory 106. The imaging guidewire 102 may include a shaft 108 and a control 110, which may include a grip 112, a control knob 114, and a coupler 116, which may be connected to the control unit 16 via a cable 118 (see fig. 4). The imaging guidewire 102 may also include a viewing module 119 including an imaging device 120 and an illumination device 122, and a nose cone 124.

The concentrically mounted accessory 104, described in more detail with reference to fig. 2A and 7A-7C, may include a shaft 126 including a lumen 128, a deployable device 130, and a control device 132. The control device 132 may include a grip 133, a control knob 134, and a coupler 135, which may be connected to the control unit 16 via a cable 136.

The lower mounted accessory 106, described in more detail with reference to fig. 2B and 8-10, may include a shaft 138 that includes a lumen 140 and a control device 142. The control device 142 may include a grip 144, a control knob 146, and a coupler 148, which may be connected to the control unit 16 via a cable 150.

The control unit 16 may provide operational capabilities to the system 100, such as power, intervention power, irrigation, aspiration, and the like. The control unit 16 is described in more detail with reference to fig. 3 and 4.

As discussed in more detail herein, the imaging guidewire 102 may be directed to an anatomical site to facilitate diagnosis and assessment of anatomical features that may be subject to intervention (e.g., sampling or treatment). In an example, as discussed with reference to fig. 3-5C, the imaging guidewire 102 can be guided to the anatomical site via a duodenal mirror. Once the anatomical feature is diagnosed, the accessory device may be guided to the anatomical site via the imaging guidewire 102. Thus, the surgeon may determine a treatment plan that is beneficial to the patient or beneficial to the surgeon intraoperatively. The accessory 104 can be slid over the imaging guidewire 102 to the anatomical site. In an example, accessory 104 can include a stent delivery system and a stent. Whether underneath, above, or beside, the accessory 106 can slide along the imaging guidewire 102 via an attachment mechanism 170 (see fig. 2B). In an example, as shown in fig. 9, the accessory 106 may include a body with integrated lithotripsy capability and a flushing system. In an example, as shown in fig. 10, the accessory 106 can include a body that includes a working channel for guiding another instrument that includes a tissue remover, tissue retriever, forceps, electrohydraulic lithotripsy (EHL) probe, basket, and the like. Thus, the modular endoscope system 100 can reduce surgical complexity by providing an imaging guidewire 102 that can be readily used by various surgeons with different skills. The imaging guidewire 102 may then facilitate the use of certain desired accessories that may be used with the expertise of different surgeons. The imaging guidewire 102 may remain within the patient while the imaging guidewire 102 may be used to passively deliver one or more accessories to the anatomical site of the target anatomy, thereby reducing the number of active navigation, manipulation, or navigation of individual instruments into the duodenum and common bile ducts or other anatomical locations to perform various procedures.

The imaging guidewire 102 may be configured as an imaging device that may be maneuvered and navigated to a desired anatomical location to view and evaluate an anatomical structure. If desired, fluorescence may be used to guide the imaging guidewire 102 to the desired anatomical location. The shaft 108 of the imaging guidewire 102 may include a pull wire (not shown) that may be used to manipulate the imaging guidewire 102. The control device 110 may be used to operate the imaging guidewire 102 including the pull wire. For example, the grip 112 may be gripped by an operator and the control knob 114 may be rotated to pull one or both of the pull wires to impart directionality to the shape of the shaft 108.

In an example, the shaft 108 may include a lumen (not shown) to allow the passage of connection elements (e.g., wires and cables) for the imaging device 120 and the illumination device 122. In an example, the shaft 108 may include a sheath disposed around the wires and cables. In an example, the viewing module 119 can include wireless communication circuitry including one or more transponders or beacons that can use mature wireless communication protocols (e.g., 3G, 4G, 5G,) And wireless internet protocols (e.g., 802.11 and WiFi). In an advantageous aspect, bluetooth may be used to achieve a desired data transmission rate and low power consumption rate.

The shaft 108 of the imaging guidewire 102 may be flexible to facilitate insertion through various shapes of anatomical structures. The shaft 108 may be made of a suitable material that is sufficiently compliant to be guided by a pull wire, but sufficiently rigid to allow insertion through an anatomical structure. In an example, the shaft 108 may be made from various polymers. In the illustrated example, the shaft 108 may include a circular cross-section centered about a central axis. In other examples, the shaft 108 may have other cross-sectional profiles, such as rectilinear and polygonal. The control device 110 may have the same or similar cross-sectional profile as the shaft 108, allowing other components such as the attachment 104 to be assembled proximally onto the shaft 108. In an example, one or both of the following allows other components, such as accessory 104, to be fitted proximally onto shaft 108: the control device 110 is detachable from the shaft 108 and the coupler 116 is detachable from the control device 110.

The control device 110 may additionally be used to operate the imaging device 120 and the illumination device 122. The control knob 114 or another component may include a button, switch, etc. to selectively turn on and off the power to the imaging device 120 and the illumination device 122. In an example, the brightness of the illumination device 122 may be adjusted. The imaging device 120 may include a camera similar to that described with reference to the objective lens 60 of fig. 5A. The illumination device 122 may be configured to emit light waves, similar to that described with reference to the lens 58 of fig. 5A. The illumination device 122 may comprise a light emitting fiber connected to a light generator in the control device 110 or the control unit 16 (see fig. 3). The viewing module 119 may also include a photosensitive element, such as a charge coupled device ("CCD" sensor) or a complementary metal oxide semiconductor ("CMOS") sensor, for example, to obtain video images. In either example, the imaging device 120 may be coupled (e.g., via a wired or wireless connection) to the image processing unit 42 (see fig. 4) to transmit signals (e.g., video signals) representing images from the light sensing elements to the image processing unit 42 for display on a display such as the output unit 18 (see fig. 3). In various examples, the imaging and control system 12 (see fig. 3) and imaging device 120 may be configured to provide an output of a desired resolution (e.g., at least 480p, at least 720p, at least 1080p, at least 4K UHD, etc.) suitable for endoscopic surgery.

Nose cone 124 may include a cover positioned in front of and may be attached to viewing module 119. The nose cone 124 may be configured to shield the viewing module 119 and prevent fluid from entering the imaging guidewire 102. Additionally, the nose cone 124 may be tapered and have a rounded leading edge or tip to prevent damage to tissue and to help push the tissue away from the imaging guidewire during insertion. Nose cone 124 may be made of a soft, flexible material and may also be clear or transparent to allow light waves to enter and exit viewing module 119. Additionally, nose cone 124 may be configured as a stop to prevent the accessory from sliding off of imaging guidewire 102, for example by having a slightly larger diameter than the imaging guidewire or by closing the end of a sliding channel for coupling to the accessory.

In an example, the imaging guidewire 102 may be configured similar to a fully functional speculum that includes maneuverability, guidance capabilities, imaging functionality, and illumination capabilities, but without functionality such as therapeutic and diagnostic functions. The functionality of the imaging guidewire 102 may be provided by different accessories (e.g., concentrically mounted accessory 104 and an undermounted accessory 106).

In an example, the concentrically mounted accessory 104 may be configured to provide functionality to the imaging guidewire 102 as well as other conventional devices (e.g., catheters and stents) used with guidewires and delivery systems for such implantable devices. Concentrically mounted accessory 104 may include a shaft 126 and a deployable device 130, which may be configured as a stand. As shown in fig. 2A, the imaging guidewire 102 may be positioned within the lumen 128 of the shaft 126, and the deployable device 130 may be positioned around the shaft 126.

In an example, the undermounted accessory 106 can be configured to provide complementary functionality to the imaging guidewire 102, as with a conventional endoscope (e.g., a choledochoscope). As shown in fig. 2B, the undermounted accessory 106 may include a working channel 160, a flushing channel 162, and an auxiliary channel 164. The imaging guidewire 102 may be sized to occupy less than the total area available within the working channel of a parent scope, such as a duodenal scope, to allow additional devices to pass through the parent scope simultaneously with the imaging guidewire 102 a. The combined dimensions of imaging guidewire 102 and one of accessory 104 and accessory 106 may be configured to fit within a working channel of a duodenal scope (e.g., endoscope 14 of fig. 3 and 4). In an example, the outer diameter of the duodenal mirror can be in the range of about 10mm to about 12.0 mm. As described below, in additional examples, the diameter ("diameter D1") of a working channel of a duodenal mirror, such as lumen 62 of fig. 6, may be about 5.0mm or less.

The shaft 108 of the imaging guidewire 102 may have a second diameter. The diameter D2 may be as small as possible while still providing sufficient strength and flexibility as a guidewire and connected to an imaging device or the like capable of obtaining a suitable image with a sufficiently large field of view. In an example, D2 may be about 3.0mm or less. In additional examples, D2 may be in the range of about 0.8mm to about 1.0mm or less, as described below. In contrast, existing choledochoscope designs typically have an outer diameter of about 3.4mm, with typical non-imaging guidewires having diameters of about 0.8mm to 1.0 mm.

Concentrically mounted accessory 104 may have a third diameter D3 (see fig. 2A). The outer diameter D3 of the concentrically mounted attachment 104 may be sized to fit within the working channel of the duodenal mirror along with the shaft 108. The second diameter D2 may range from just less than D1 to just greater than D2. In an example, the diameter D3 may be in the range of about 3.4mm or less. The shaft 126 of the concentrically mounted accessory 104 may be configured to slide freely about the shaft 108 of the imaging guidewire 102.

The undermounted accessory 106 may have a fourth diameter D4 (see fig. 2B). The outer diameter D4 of the undermounted attachment 106 may be sized to fit within the working channel of the duodenal mirror alongside the shaft 108. Diameter D4 may be as large as the difference between D1 and D2. In an example, the diameter D4 may be about 5.0mm or less.

The size and dimensions of the duodenoscope (e.g., the speculum 14 of fig. 3), the imaging guidewire 102, the concentrically mounted accessory 104, and the underneath mounted accessory 106 may be selected or manufactured as part of a kit or system configured for compatibility as discussed herein. Thus, the use of a dedicated sub-device within the parent endoscopic device configured to perform a specific task within the anatomy after insertion through the parent endoscope may be avoided or eliminated. For example, the use of a choledochoscope may be replaced by using the imaging guidewire 102 and accessories with a choledochoscope function, including the endoscope with a choledochoscope and internal lithotripter function described herein. Likewise, the use of a stent delivery system may be replaced by the use of an imaging guidewire 102 and an accessory with stent delivery system capabilities. Thus, the imaging guidewire 102 can be widely adapted by different surgeons using different sub-devices with a parent device to perform the same procedure, as well as different surgeons using the same parent device to perform different procedures. Thus, hospitals and medical facilities can reduce the inventory and training required to provide extensive endoscopic procedures, particularly in the gastrointestinal tract.

Fig. 2A is a schematic illustration of the exterior arrangement of the concentrically mounted attachment 104 of fig. 1 around the imaging guidewire 102. Fig. 2A may show an end view of the distal end of concentrically mounted accessory 104. Imaging guidewire 102 may include a shaft 108, an imaging device 120, and illumination devices 122A, 122B, and 122C. Concentrically mounted accessory 104 may include a shaft 126 having a lumen 128 and a deployable device 130.

The imaging guidewire 102 can be configured to be inserted through an anatomical structure to facilitate insertion of the accessory 104 thereafter. The accessory 104 can be configured as any number of different systems that can be used to deliver a device via a guidewire. The shaft 126 may include a delivery device configured to carry the deployable device 130. In an example, the deployable device 130 may include a stent, a drug delivery device, a filter, a valve, a catheter (e.g., a balloon dilation catheter), and the like.

In the illustrated example, the shaft 126 may include a delivery device configured to carry a deployable device 130 including a stent. The shaft 126 may include a tube having an inflatable portion on which the deployable device 130 is positioned. The shaft 126 may be used to push the deployable device 130 over the imaging guidewire 102 to a desired anatomical region. As discussed with reference to fig. 7A-7C, the deployable device 130 may include a stent including a mesh sleeve that may be switched from a collapsed configuration having a first small diameter to an expanded configuration having a second large diameter, and pressurized air or gas may be directed into the lumen 128 to inflate the inflatable portion to expand the deployable device 130 from the collapsed configuration to the expanded configuration. Control device 132 may be operated, for example via 134, to selectively control the flow of pressurized medium through shaft 126 and to control the flow of pressurized medium into deployable device 130. When pressurized medium is no longer provided, the deployable device 130 may remain in the form of an expanded configuration. Accordingly, the deployable device 130 may be used to open an anatomic passageway, such as the sphincter of aoutsche 186 (see fig. 6), thereby making it easier to insert other medical devices and instruments.

The concentrically mounted appendage 104 can take advantage of the presence of the lumen 128, as incorporated into existing designs of various annular devices, which can allow the appendage 104 to be positioned on the imaging guidewire 102. Additionally, the radial symmetry of the shaft 126 and the deployable device 130 may facilitate functionality between the imaging guidewire 102 and a delivery device (e.g., a duodenoscope). Although depicted as being mounted concentrically, the attachment 104 need not be coaxial with the imaging guidewire 102. Additionally, the concentrically mounted appendage 104 or other appendage need not completely surround the imaging guidewire 102 around the entire circumference of the imaging guidewire 102. Furthermore, the outer perimeter of the imaging guidewire 102 and the appendage 104 need not be circular, and the outer perimeter of the imaging guidewire 102 and the lumen 128 need not be complementary in shape.

Lumen 128 may allow attachment of concentrically mounted accessory 104 to imaging guidewire 102 in a slidable state without the use of separate attachment or coupling features. As discussed above, the diameter D2 of the imaging guidewire 102 may be small enough to allow for the passage of various accessories over the imaging guidewire. The diameter D3 of the concentrically mounted appendage 104 can be as large as desired to fit within an anatomical structure or another range of working channels.

The imaging guidewire 102 may also include a guidewire component 172 of the attachment mechanism 170. As discussed in more detail with reference to fig. 2B, the guidewire component 172 can be positioned over the imaging guidewire 102 to facilitate attachment of other accessories to the shaft 108 without having to rely on the accessories restraining or partially surrounding the imaging guidewire 102. The wire member 172 can be positioned within the outer perimeter or boundary of the shaft 108 such that the wire member 172a does not interfere with the sliding of the accessory 104 around the imaging guidewire 102. The shaft 126 may be configured to slide past the distal end of the imaging guidewire 102, past the nose cone 124, allowing the deployable device to be placed within an anatomy and separated from the imaging guidewire 102 within the anatomy.

Fig. 2B is a schematic illustration of the attachment 106 of fig. 1 mounted underneath attached to the bottom of the imaging guidewire 102. Fig. 2B may show an end view of the distal end of the attachment 106 mounted underneath. Imaging guidewire 102 may include a shaft 108, an imaging device 120, and illumination devices 122A-122C. The undermounted accessory 106 may include a shaft 138 that includes a working channel 160, a flushing channel 162, and an auxiliary channel 164. The imaging guidewire 102 and the mounted accessory 106 below may be attached via an attachment mechanism 170, which may include a guidewire component 172 and an accessory component 174.

As discussed with reference to fig. 9 and 10, the undermounted accessory 106 may be configured with a variety of different functions to meet the needs and desires of different users and the needs of different procedures. In the example illustrated in fig. 2B, working channel 160 may include a hollow channel or lumen configured to receive another instrument or device, irrigation channel 162 may be connected to a fluid source, such as saline, to distribute fluid into the anatomy, and auxiliary channel 164 may be configured to receive fluid or another device as desired. Additionally, one or more auxiliary channels 164 may be provided to incorporate an operator or pull wire that may be connected to the control device 142 to cause steering or bending of the shaft 138. Any one or more of working channel 160, irrigation channel 162, and auxiliary channel 164 may represent lumen 140 of fig. 1.

Fig. 2B schematically illustrates a guidewire component 172 and an accessory component 174 of the attachment mechanism 170. The attachment mechanism 170 may include any device configured to radially attach the accessory 106 to the imaging guidewire 102 while additionally allowing axial movement therebetween. The attachment mechanism 170 may extend along the length of the axial interface between the imaging guidewire 102 and the accessory 106, or may be intermittently positioned along the axial interface. As discussed below, the wire guide member 172 may include a slot and the accessory member 174 may include a guide rail configured to ride in the slot. In an example, the guidewire component 172 can include a stop that prevents the accessory component 174 from sliding off the end of the imaging guidewire 102. In an example, a slot including a guidewire feature 172 may terminate near the distal end of the shaft 108, configured to allow an accessory feature 174 to abut an end of the slot to prevent the accessory from disengaging the imaging guidewire 102 or sliding past the viewing module 119. As mentioned previously, fig. 2B is described with reference to a slot and rail configuration, but other means may be used to hold the imaging guidewire 102 and the undermounted accessory 106 is in an axially slidable relationship, such as a ring, magnet, and other means, while also allowing the concentrically mounted accessory 104 to fit over the imaging guidewire 102. For example, a flexible strip may be attached to an imaging guidewire to form a loop that may receive an undermounted accessory 106, but may be folded into a concentrically mounted accessory 104. Additionally, magnets may be positioned along the length of the imaging guidewire 102 to interact with a metal strip or magnetic stripe mounted on the accessory 106 below.

Fig. 2A and 2B illustrate illumination devices 122A-122C that include three separate devices positioned to surround imaging device 120. The guidewire component 172 may be positioned between the illumination devices 122A and 122C to help keep the size of the imaging guidewire 102 small. Likewise, an operator or pull wire may be positioned between the spaced apart illuminators 122A-122C, which may be connected to the control device 110 to cause steering or bending of the shaft 108. However, any number of lighting devices may be used. In an example, one or more of the illumination devices may be arranged to form annular light centered on the imaging device 120. In additional examples, the imaging device 120 and the one or more illumination devices may be arranged in other devices. For example, a single illumination device and imaging device 120 may be arranged in a side-by-side configuration. Additionally, a plurality of lighting devices may be arranged in a side-by-side configuration. The illumination devices 122A-122C may include various light emitters configured to emit visible light to aid the imaging device 120. In an example, the lighting devices 122A-122C may include Light Emitting Diodes (LEDs). In an example, the diameter of the imaging device 120 may be in the range of 0.3mm to about 0.7 mm. In an example. Each of the illumination devices 122A-122C may have a diameter in the range of 0.3mm to about 0.7 mm. In an example, a 0.5mm imaging microchip may be surrounded by a ring of optical fibers, each having a diameter of about 0.3 mm. In an example, a 0.5mm imaging microchip can be surrounded by a hollow fiber having a diameter of about 0.8 mm. In a particular example, the imaging guidewire can have a diameter of about 0.8mm for use with a duodenoscope having a working channel diameter of about 4.2mm such that the total cross-sectional thickness of the concentrically mounted appendage 104 and the underlying appendage is about 3.4mm or less.

Fig. 3 is a schematic view of endoscope system 10 including imaging and control system 12 and endoscope 14. The system of fig. 3 is an illustrative example of an endoscopic system suitable for use with the systems, devices, and methods described herein, such as an imaging guidewire and an accessory configured to be guided by the imaging guidewire. According to some examples, endoscope 14 may be inserted into an anatomical region for imaging and/or providing one or more sampling devices for biopsy or one or more treatment devices (e.g., stents) for treating a disease state associated with the anatomical region. In an advantageous aspect, the endoscope 14 can interface with and be connected to the imaging and control system 12. In the illustrated example, the endoscope 14 includes a duodenal scope, but other types of endoscopes may also be used with the features and teachings of the present disclosure.

The imaging and control system 12 may include a control unit 16, an output unit 18, an input unit 20, a light source unit 22, a fluid source 24, and a suction pump 26.

Imaging and control system 12 may include various ports for coupling with endoscope system 10. For example, the control unit 16 may include a data input/output port for receiving data from and transmitting data to the endoscope 14. The light source unit 22 may include an output port for transmitting light to the endoscope 14, for example via an optical fiber link. The fluid source 24 may include a port for delivering fluid to the endoscope 14. The fluid source 24 may include a pump and a reservoir, or may be connected to an external tank, container, or storage unit. Suction pump 26 may include a port that is used to draw a vacuum from endoscope 14 to generate suction, for example, to draw fluid from an anatomical region into which endoscope 14 is inserted. An operator of endoscope system 10 may use output unit 18 and input unit 20 to control the functions of endoscope 10 and view the output of endoscope 14. Additionally, the control unit 16 may be used to generate signals or other outputs for treating the anatomical region into which the endoscope 14 is inserted. In an example, the control unit 16 may generate an electrical output, an acoustic output, a fluid output, etc. for treating an anatomical region by, for example, cauterization, cutting, freezing, etc.

Endoscope 14 may include an insertion portion 28, a functional portion 30, and a handle portion 32, which may be coupled to a cable portion 34 and a coupler portion 36. The coupler section 36 may be connected to the control unit 16 to connect the endoscope 14 to various features of the control unit 16, such as the input unit 20, the light source unit 22, the fluid source 24, and the suction pump 26.

The insertion portion 28 may extend distally from the handle portion 32, and the cable portion 34 may extend proximally from the handle portion 32. The insertion portion 28 may be elongate and include a curved portion and a distal end to which the functional portion 30 is attached. The curvature may be controlled (e.g., by a control knob 38 on the handle portion 32) to steer the distal end through a curved anatomic passageway (e.g., stomach, duodenum, kidney, ureter, etc.). The insertion portion 28 may also include one or more working channels (e.g., an internal lumen) that may be elongated and support insertion of one or more treatment tools (e.g., the modular endoscope system 100 of fig. 1) of the functional portion 30. The working channel may extend between the handle portion 32 and the functional portion 30. Additional functional devices such as fluid channels, guidewires, and pull wires may be provided by the insert 28 (e.g., via aspiration or irrigation channels, etc.).

The handle portion 32 may include a control knob 38 and a port 40A. The control knob 38 may be coupled to a pull wire or other actuation mechanism that extends through the insertion portion 28. The ports 40A and 40B (see fig. 2A and 2B) may be configured to couple various cables, guidewires, auxiliary mirrors, tissue collection devices of the present disclosure, fluid tubing, etc. to the handle portion 32 for coupling with the insertion portion 28.

According to an example, the imaging and control system 12 may be provided on a mobile platform (e.g., a cart 41) having shelves for housing the light source unit 22, the suction pump 26, the image processing unit 42 (see fig. 4), and the like. Alternatively, several components of the imaging and control system 12 shown in fig. 3 and 4 may be provided directly on the endoscope 14 to make the endoscope "self-sufficient".

The functional part 30 may include components for treating and diagnosing the anatomy of the patient. The functional part 30 may include an imaging device, an illumination device, and a lifter, for example, as further described with reference to the lifter 54 of fig. 5A to 5C. Further, the functional portion 30 may include one or more electrodes conductively connected to the handle portion 32 and functionally connected to the imaging and control system 12 to perform ablation or the like. Similarly, the functional portion 30 may be configured to perform cauterization, cutting, freezing, and the like. In additional examples, functional portion 30 may incorporate a tissue collector or tissue retrieval device to remove biological material from the anatomy.

Fig. 4 is a schematic view of the endoscope system 10 of fig. 3 including the imaging and control system 12 and the endoscope 14. Fig. 4 schematically illustrates components of the imaging and control system 12 coupled to an endoscope 14, which in the illustrated example includes a duodenal scope. Imaging and control system 12 may include a control unit 16, which may include or be coupled to an image processing unit 42, a therapy generator 44, and a drive unit 46, as well as a light source unit 22, an input unit 20, and an output unit 18. The coupler portion 36 may be connected to the control unit 16 to connect the endoscope 14 to various features of the control unit 16, such as the image processing unit 42 and the therapy generator 44. In an example, port 40A may be used to insert another instrument or device (e.g., a sub-scope or auxiliary scope) into endoscope 14. Such instruments and devices may be independently connected to the control unit 16 via the cable 47. In an example, the port 40B may be used to connect the coupler portion 36 to various inputs and outputs, such as video, air, light, and electricity. The control unit 16 may be in communication with the modular endoscope system 100 and may be configured to operate its features in conjunction with the control devices 110, 132, and 142 (see fig. 1) and provide various inputs to the modular endoscope system 100, such as power, ablation energy, cautery energy, laser energy, irrigation fluid, suction, compressed gas, and the like. The control unit 16 may be configured to activate the camera to view the target tissue at the distal end of the endoscope 14. Likewise, the control unit 16 may be configured to activate the light source unit 22 to illuminate light onto a surgical instrument extending from the endoscope 14. In an example, endoscope 14 can include a duodenum into which imaging guidewire 102, accessory 104, and accessory 106 are inserted.

The image processing unit 42 and the light source unit 22 may each interface with the endoscope 14 (e.g., at the functional unit 30) through a wired or wireless connection. Imaging and control system 12 may illuminate the anatomical region, collect signals representative of the anatomical region, process the signals representative of the anatomical region, and display an image representative of the anatomical region on display unit 18, accordingly. The imaging and control system 12 may include a light source unit 22 to illuminate the anatomical region with light of a desired spectrum (e.g., broadband white light, narrowband imaging, preferably using electromagnetic wavelengths, etc.). The imaging and control system 12 may be connected (e.g., via an endoscope connector) to the endoscope 14 for signal transmission (e.g., light output from a light source, video signals from a remote imaging system, diagnostic signals and sensor signals from a diagnostic device, etc.).

The fluid source 24 (see fig. 3) may be in communication with the control unit 16 and may include one or more sources of air, saline, or other fluid, as well as associated fluid passages (e.g., air passages, irrigation passages, aspiration passages) and connectors (barb fittings, fluid seals, valves, etc.). The imaging and control system 12 may also include a drive unit 46, which may be an optional component. The drive unit 46 may include a motorized drive for advancing the distal portion of the endoscope 14, as described in PCT publication No. wo 2011/140118 A1 entitled "rotary advancement catheter system," at least Frasica et al, which is incorporated herein by reference in its entirety.

Fig. 5A to 5C illustrate a first example of the functional section 30 of the endoscope 14 of fig. 3 and 4. Fig. 5A illustrates a top view of the functional part 30, and fig. 5B illustrates a cross-sectional view of the functional part 30 taken along the cross-section 5B-5B of fig. 5A. Fig. 5A and 5B each illustrate a "side view endoscope" (e.g., duodenum) camera module 50. In the side-view endoscopic camera module 50, the illumination and imaging system is positioned such that the view angle of the imaging system corresponds to the target anatomy flanking the central longitudinal axis A1 of the endoscope 14.

In the example of fig. 5A and 5B, the side-view endoscopic camera module 50 may include a housing 52, a riser 54, a fluid outlet 56, an illumination lens 58, and an objective 60. The housing 52 may form a fluid-tight coupling with the insert 28. The housing 52 may include an opening for the lifter 54. Lifter 54 may include a mechanism for moving the device inserted through insertion portion 28. In particular, as discussed in more detail with reference to fig. 5C, lifter 54 may include a device that may bend an elongate device extending through insert 28 along axis A1. The elevator 54 may be used to bend the elongated device at an angle to the axis A1 to treat anatomical regions adjacent the side view endoscopic camera module 50. The lifter 54 is located beside the axis Al, the illumination lens 58, and the objective lens 60, for example, radially outward of the axis Al, the illumination lens 58, and the objective lens 60.

As seen in fig. 5B, the insertion portion 28 may include a central lumen 62 through which various components may extend through to connect the functional portion 30 with the handle portion 32 (see fig. 4). For example, the illumination lens 58 may be connected to a light emitter 64, which may include a fiber optic cable or cable bundle (see fig. 3) extending to the light source unit 22. Likewise, the objective lens 60 may be coupled to a prism 66 and an imaging unit 67, which may be coupled to wiring 68. Further, the fluid outlet 56 may be coupled to a fluid line 69, which may include a tube that extends to the fluid source 24 (see fig. 3). Other elongated elements, such as tubes, wires, cables, may extend through lumen 62 to connect functional portion 30 with components of endoscope system 10, such as suction pump 26 (see fig. 3) and therapy generator 44 (see fig. 4).

Fig. 5C is a schematic cross-sectional view taken along section 5C-5C of fig. 5A, showing lifter 54. The lifter 54 may include a deflector 55, which may be disposed in the space 53 of the housing 52. Deflector 55 may be connected to wire 57, which may extend through tube 59 to connect to handle portion 32. The wire 57 may be actuated, for example, by rotating a knob, pulling a lever, or pushing a button on the handle portion 32. Movement of wire 57 may cause rotation (e.g., clockwise) from a first position of deflector 55 about pin 61 to a second position of deflector 55, as indicated by 55'. The deflector 55 may be actuated by the wire 57 to move a distal portion of the instrument 63 extending through a window 65 in the housing 52.

The housing 52 may include an accommodating space 53 accommodating the deflector 55. The instrument 63 may include forceps, catheters, etc. that extend through the lumen 62. The proximal end of deflector 55 may be attached to housing 52 at a pin 618 provided at rigid tip 21. When the deflector 55 is in the lowered or unactuated state, the distal end of the deflector 55 may be located below a window 65 in the housing 52. When the deflector 55 is lifted or actuated by the wire 57, the distal end of the deflector 55 may extend at least partially out of the window 65. Instrument 63 may slide over inclined ramp 51 of deflector 55 to initially deflect the distal end of instrument 63 toward window 65. The inclined ramp 51 may facilitate the distal portion of the instrument 63 extending from the window 65 at a first angle relative to the axis of the lumen 62. The inclined ramp 51 may include a groove 69, such as a v-shaped notch, to receive and guide the instrument 63. Deflector 55 may be actuated to bend instrument 63 at a second angle relative to the axis of lumen 62 that is closer to vertical than the first angle. When the wire 57 is released, the deflector 55 can be rotated back to the lowered position, e.g. counter-clockwise, by pushing or releasing the wire 57.

Fig. 6 is a diagram illustrating the insertion of the endoscope 14 and imaging guidewire 102 into an anatomical structure 180 to reach the duodenum D. The endoscope 14 may extend into the patient's mouth and through the esophagus, through the stomach, and to the duodenum D.

Endoscope 14 may include a functional module 50 and shaft 34, and may be connected to control unit 16. The coupler portion 36 of the endoscope 14 may be connected to the control unit 16. As described with reference to endoscope system 10 (see fig. 3) and control unit 16 (see fig. 4), control unit 16 may include other components including light source unit 22, image processing unit 42, and therapy generator 44. Additionally, the control unit 16 may include control, activation, energizing, illumination, and imaging components, as well as other components for operating the modular endoscope system 100 as described herein.

The duodenum D may include common bile duct 182, a duct wall 184, an sphincter of oldhami 186, and a main pancreatic duct 188. The duodenum D includes the upper portion of the small intestine. Common bile duct 182 carries bile from the gallbladder and liver (not shown) and empties the bile into the duodenum D through the sphincter of aoutsche 186. The main pancreatic duct 188 delivers pancreatic juice from the exocrine pancreas (not shown) to the common bile duct 182. It may sometimes be desirable to remove biological material (e.g., tissue) from the bile duct 182 or the primary pancreatic duct 188 to analyze the tissue, for example, to diagnose a disease or condition such as cancer in a patient.

The functional module 50 may include a lifter 54. Endoscope 14 may also include a lumen 62 into which imaging guidewire 102 is inserted. The imaging guidewire 102 may include an imaging device 120. Although not shown for simplicity, the imaging guidewire 102 itself may include functional components such as illumination devices 122A, 122B, and 122C to facilitate navigation of the imaging guidewire 102 from the endoscope 14 through the anatomy 180 and to facilitate viewing of components extending from the imaging guidewire 102. The elevator 54, with integrated steering capabilities of the imaging guidewire 102 (e.g., pull wires), may be used to steer the imaging guidewire 102 from the lumen 62 toward the sphincter of aoutsche 186.

In some duodenal endoscopic procedures (e.g., endoscopic retrograde cholangiopancreatography, hereinafter "ERCP" procedure), an auxiliary scope (also referred to as a sub-scope or choledochoscope) may be attached and advanced through a central lumen (e.g., lumen 62) such as the "main scope" (also referred to as a parent scope or duodenoscope) of endoscope 14. However, inserting a child scope into a parent scope may limit the procedures performed thereafter without removing the child scope and inserting another instrument. This process can be time consuming as it can involve the problem of having to reconsider access to the sphincter of aoshi 186. As discussed in more detail below, the imaging guidewire 102 may be directed into the sphincter of oldhami 186. Thus, a surgeon operating the imaging guidewire 102 may navigate the imaging guidewire 102 through the lumen 62 toward the gallbladder, liver, or other location in the gastrointestinal system to evaluate the anatomy and determine which instrument is needed to perform various procedures. The surgeon may navigate the imaging guidewire 102 through the portal 190 of the common bile duct 182 and into the channel 192 of the common bile duct 182, or into the portal 190. The imaging guidewire 102 may be used to navigate the concentrically mounted appendage 104 and the underlying appendage 106 to an anatomical structure to perform various procedures, such as implantation of a stent and acquisition of biological material, such as by sliding along the imaging guidewire 102. Accessory devices may have their own functional devices such as light sources, accessories and biopsy channels for treatment surgery. As described with reference to fig. 9 and10, the accessory device may include various features for collecting biological material (e.g., tissue). The biological material may then be removed from the patient, typically by removing the additional device from the auxiliary device, so that the removed biological material may be analyzed to diagnose one or more conditions of the patient. According to several examples, the endoscope 14 and the devices inserted therein may be adapted for removal of cancerous or precancerous material (e.g., carcinoma, sarcoma, myeloma, leukemia, lymphoma, etc.), endometriosis assessment, bile duct biopsy, etc.

Fig. 7A is a schematic view of an accessory device 200 coupled to an imaging guidewire 102. Accessory device 200 may include a cradle 202 and a delivery device 204. Accessory device 200 may include an example of concentrically mounted accessory 104. The stent 202 may include an inflatable balloon 206 and an inflatable body 208. Fig. 7A shows the inflatable body 208 and the inflatable balloon 206 in a collapsed state. The inflatable body 208 may include a mesh body having an outer diameter 210 and an interior space 212. The delivery device 204 may extend distally toward the stent 202 through the expandable body 208 and may extend distally from the stent 202. The inflatable balloon 206 may include an inflatable balloon body having an interior space 214.

In an example, the inflatable body 208 and balloon 206 may be navigated to the duodenum D using the various devices described herein (e.g., imaging guidewire 102 and endoscope 14). The delivery device 204 may include insertion instruments, tubes, or sheaths that may be used to extend the stent 202 through a working channel of an endoscope, such as the lumen 62 of the endoscope 14, while positioned around the imaging guidewire 102.

Fig. 7B is a schematic view of the accessory device 200 of fig. 7A in an expanded state. Balloon 206 may be inflated to expand inflatable body 208 from diameter Dls to diameter D2s. Balloon 206 is inflated by passing pressurized air or another gas through delivery device 204 or a tube therein. Balloon 206 may thereby expand interior space 212. The material of the inflatable body 208 may be stretched or deformed to expand to an inflated state. The material of the inflatable body 208 may remain in shape after the balloon 206 is deflated. Thus, the inner space 212 can be maintained at the diameter D2s. Thus, the balloon 206 and delivery device 204 may be removed from the stent 202 and patient by inserting the working channel of the device.

Fig. 7C is a schematic view of the duodenum D of fig. 6 with the inflatable body 208 of the stent 202 inserted into the duodenal papilla 230. The expandable body 208 of the stent 202 may comprise an annular cylindrical body that pushes the sphincter of aoutsche 186 into an expanded state. The inflatable body 208 may be delivered to the duodenum D in a collapsed state and then expanded to provide access into the common bile duct 182.

To push the stent 202 into the duodenal papilla 230, the sphincter of aor 186 (see fig. 6) may be cut to relax the tissue of the duodenal papilla 230, thereby facilitating insertion of the stent 202. The duodenal papilla 230 may be cauterized to reach the sphincter of aor 186. Thus, the duodenal papilla 230 can be opened or enlarged to receive the stent 530.

Fig. 8 is a close-up schematic view of an attachment mechanism 170 including a rail system for connecting the underneath-mounted accessory 106 of fig. 1 and 2B, wherein the underneath-mounted accessory includes a working channel 160, a flushing channel 162, and an auxiliary channel 164. In the example of fig. 8, the wire guide member 172 of the attachment mechanism 170 may include a slot 250 and the accessory member 174 of the attachment mechanism 170 may include a guide rail 252. Slot 250 may include a base 254 and an opening 256. The rail 252 may include a head 258 and a neck 260. In an example, the guide rail 252 can be disposed on an imaging guidewire and the slot 250 can be disposed on the attachment 106 mounted below.

The slot 250 and rail 252 can be configured to allow the accessory 106 to be slidably attached to the imaging guidewire 102. The slots 250 and rails 252 may interact to prevent circumferential and radial movement of the appendage 106 relative to the imaging guidewire 102, but allow axial movement. The head 258 and the base 254 are illustrated as having a rectangular or balloon shape. However, other shapes, such as circular, rectilinear, and arcuate, may also be used. In an example, the shape of the head 258 and the base 254 can provide radial interference to movement of the accessory 106 away from the imaging guidewire 102. Thus, the head 258 can be wider than the opening 256 to prevent the accessory 106 from moving radially away from the imaging guidewire. The head 258 may be slightly smaller than the base 254 to allow the accessory 106 to move freely along the imaging guidewire 102.

Fig. 9 is a schematic view of a modular endoscope system 100 that includes an imaging guidewire 102 attached to an undermounted accessory 106A having an irrigation channel 270 and a laser fiber 272. The underneath-mounted accessory 106A can include example configurations of the accessory 106 of fig. 1-2B. The flush channel 270 may be configured to dispense a flush fluid 274. The laser fiber 272 may be configured to emit a light beam 276. The distal end of the modular endoscope system 100 may be inserted into an anatomical tube 280 where biological material 282 may be located. In an example, the biological material 282 may include a stone such as a kidney stone or gall stone.

The laser fiber 272 may be integrated into the material of the undermounted accessory 106A, such as embedded therein. The laser fiber 272 can be coupled to the control 142 of the accessory 106A such that a user can selectively emit a light beam 276. The irrigation channel 270 may be connected to the control device 142 and the control unit 16, where a source of irrigation fluid may be supplied.

As discussed herein, the imaging guidewire 102 can be navigated to the anatomical tube 280 using the viewing module 119 without attaching the accessory 106A to the anatomical tube. The imaging and viewing light of the viewing module 119 can be used to view the anatomical tube 280 prior to attachment of the accessory 106A to the imaging guidewire 102 in order to assess the anatomy. The surgeon may view the video image to determine the presence, location, and condition of the biological material 282. In the example of fig. 9, the surgeon may decide that a laser lithotripsy-enabled accessory is required to treat the biological material 282. Accordingly, an attachment mechanism 170 (see fig. 2B) may be used to couple the accessory 106A to the imaging guidewire 102. For clarity, the attachment mechanism 170 is not illustrated in fig. 9. However, as discussed below, the attachment mechanism 170 can include a stop 290 that can be used to limit the distance the accessory 106A can extend along the imaging guidewire 102.

Shaft 138 of accessory 106A can have a distal face 284 from which irrigation fluid 274 and light beam 276 can emerge. For example, the distal end of the laser fiber 272 may terminate at or near the distal face 284. Likewise, the irrigation channel 270 may be open at the distal face 284. Accordingly, irrigation fluid 274 and light beam 276 may be emitted distally from shaft 138 in the direction of biological material 282.

The light beam 276, i.e., the laser beam, may be configured to break the biological material 282 into smaller pieces for disposal. In an example, the broken pieces of biological material 282 may be naturally processed through anatomical structures, such as by dissolving or traversing the gastrointestinal tract. In an example, the flushing fluid 274 may be dispensed before, during, and after use of the light beam 276 to flush away broken pieces of biological material 282 for disposal. Additionally, the irrigation fluid 274 may be used to clear debris from the viewing module 119.

In additional examples, the attachment 106A may include a working channel in which a tissue removal device, such as a basket, may be inserted for removing broken pieces of biological material 282. In an example, the laser fiber 272 may be configured to operate similar to a laser lithotripter. The stop 290 may be used to limit the extent to which the end surface 284 may access the viewing module 119. This may be used by the surgeon to obtain a consistent application of the beam 276 to the biological material 282. Additionally, the biological material 282 may be broken up by a shock wave 292 caused by the collision of the light beam 276 with the biological material 282. The stop 290 may be used to limit the extent to which the laser fiber 272 may access the shock wave 292, thereby preventing or inhibiting damage to the laser fiber 272.

Fig. 10 is a schematic view of modular endoscope system 100 including imaging guidewire 102 attached to accessory 106B, accessory 106B having a fluid channel 300 and a working channel 302 into which a removal device 304 is inserted. Accessory 106B may include example configurations of accessory 106 of fig. 1-2B. The fluid channel 300 may be configured to dispense a flushing fluid 306. The removal device 304 can include a jaw 308, a shaft 310, and a controller 312.

The distal end of the modular endoscope system 100 may be inserted into an anatomical tube 320 having biological material 322 at the anatomical tube. In an example, the biological material 322 may include a stone such as a kidney stone or gall stone.

As discussed herein, the visualization module 119 may be used to navigate the imaging guidewire 102 to an anatomical tube 320 without the attachment 106B attached thereto. The imaging and viewing light of the viewing module 119 can be used to view the anatomical tube 320 before the attachment 106B is attached to the imaging guidewire 102 in order to assess the anatomy. The surgeon may view the video image to determine the presence, location, and condition of the biological material 322. In the example of fig. 10, the surgeon may decide that an attachment with tissue removal capability is required to treat the biological material 322. For example, stones comprising biological material 322 may be small enough to be removed through anatomical structures without disruption. Accordingly, an attachment mechanism 170 (see fig. 2B) may be used to couple the accessory 106B to the imaging guidewire 102. For clarity, the attachment mechanism 170 is not illustrated in fig. 10. However, as discussed below, the attachment mechanism 170 can include a stop 324 that can be used to limit the distance the accessory 106B can extend along the imaging guidewire 102.

The shaft 138 of the accessory 106B can have a distal face 326 from which the irrigation fluid 306 and the removal device 304 can be ejected. For example, the jaws 308 of the removal device 304 may extend beyond the distal face 326 through the shaft 310. Likewise, the irrigation channel 300 may be open at the distal face 326. Thus, fluid 306 and jaws 308 may be ejected distally from shaft 138 in the direction of biological material 322.

The removal device 304 may be configured as any suitable device configured to obtain a tissue sample from within a patient. Additionally, the removal device 304 may include components or devices for interacting with a patient, such as components or devices configured to cut, slice, pull, saw, punch, twist, or auger tissue, etc. In particular, the removal device 304 may include any device suitable for removing tissue from a patient, such as a blade, punch, or auger. The removal device 304 may be configured to physically separate a tissue portion of the patient from other larger tissue portions within the patient. In additional examples, the removal device 304 may be configured to simply collect biological material, such as mucus or fluid, from the patient that does not require physical separation. In the illustrated example, the removal device 304 can include forceps, wherein the jaws 308 can be configured as sharp or serrated jaws pivotably connected at a hinge. However, as described above, the removal device 304 may be configured as various devices capable of collecting biological material, such as a punch, auger, blade, saw, and the like. Alternatively or additionally, the removal device 304 may include a biological substance collection device, a biological substance retrieval device, a tissue collection device, and a tissue retrieval device.

Fig. 11 is a schematic view of a modular endoscope system 100 including an imaging guidewire 102 extending through an accessory 106C having a fluid channel 300, a working channel 302, and a guidewire channel 305. The removal device 304 may be inserted into the working channel 302. The imaging guidewire 102 may be inserted into the guidewire channel 305. Accessory 106C may include example configurations of accessory 106 of fig. 1-2B. The fluid channel 300 may be configured to dispense a flushing fluid 306. The removal device 304 can include a jaw 308, a shaft 310, and a controller 312.

The attachment 106C may be configured similarly to the attachment 106B of fig. 10, except that the guidewire channel 305 may be incorporated into the shaft 138 and any means or function for attaching the imaging guidewire 102 to the exterior of the shaft 138 may be omitted. Thus, the accessory 106C may include a wire-mounted accessory similar to the concentrically mounted accessory 104 in that the imaging guidewire 102 is internal to the accessory and not external to the accessory in both examples.

Fig. 9-11 illustrate a particular configuration of the appendages 106A, 106B, and 106C that may be used as an accessory housing with the imaging guidewire 102. The particular features of other accessories and housings used with the imaging guidewire 102 may be selected to meet different needs for different surgical procedures or for different surgeon preferences. Thus, the appendages 106A, 106B, and 106C may be configured with more or fewer working channels and additional or auxiliary channels in other configurations, as well as different stone capture or stone breaking capabilities.

Example

Example 1 is a modular endoscope system, comprising: an imaging guidewire comprising an elongate shaft extending from a proximal end to a distal end, an imaging device positioned near the distal end of the elongate shaft, and an illumination element positioned near the distal end of the elongate shaft; and an intervention accessory configured to slide along the elongate shaft to provide a medical intervention.

In example 2, the subject matter of example 1 optionally includes a cap at the distal end of the elongate shaft, the cap being tapered to push the anatomical structure away from the imaging device.

In example 3, the subject matter of example 2 optionally includes wherein the cover is transparent and positioned such that the imaging device can be viewed through the cover.

In example 4, the subject matter of any one or more of examples 1-3 optionally includes, wherein the lighting element comprises a plurality of light emitters.

In example 5, the subject matter of example 4 optionally includes wherein the illumination element comprises an annular shape and the imaging device is positioned within the annular shape.

In example 6, the subject matter of any one or more of examples 1-5 optionally includes, wherein the elongate shaft has an outer contoured shape, and the imaging device and the illumination element are located within the outer contoured shape.

In example 7, the subject matter of example 6 optionally includes the outer contoured shape being circular and having a diameter in a range of about 0.8mm to about 3.0 mm.

In example 8, the subject matter of example 7 optionally includes the combined outer diameter of the imaging guidewire and the intervention accessory not exceeding about 5.0mm.

In example 9, the subject matter of any one or more of examples 6-8 optionally includes a sliding feature extending along at least a portion of the elongate shaft between the proximal end and the distal end.

In example 10, the subject matter of example 9 optionally includes wherein the sliding feature comprises a slot configured to receive the mating rail.

In example 11, the subject matter of example 10 optionally includes wherein the slot is located within the outer contoured shape.

In example 12, the subject matter of any one or more of examples 10-11 optionally includes, wherein the slot includes a radial detent.

In example 13, the subject matter of example 12 optionally includes wherein the slot has a T-shape.

In example 14, the subject matter of any one or more of examples 9-13 optionally includes, wherein the sliding feature comprises a distal stop.

In example 15, the subject matter of any one or more of examples 9-14 optionally includes, wherein the intervention accessory is configured to slide on and not connect with the sliding feature.

In example 16, the subject matter of example 15 optionally includes, wherein the intervention accessory includes a bracket configured to fit around the elongate shaft.

In example 17, the subject matter of example 16 optionally includes, wherein the stent includes an insertion shaft configured to position the stent along the elongate shaft.

In example 18, the subject matter of any one or more of examples 9-17 optionally includes, wherein the intervention accessory is configured to slide along and connect to the sliding feature.

In example 19, the subject matter of any one or more of examples 1-18 optionally includes, wherein the intervention accessory includes an elongated housing having at least one passage extending at least partially therethrough.

In example 20, the subject matter of example 19 optionally includes, wherein the elongated housing further includes a laser fiber extending at least partially through the elongated housing.

In example 21, the subject matter of any one or more of examples 19-20 optionally includes, wherein the elongate housing further comprises a flushing channel configured to deliver fluid through the elongate housing.

In example 22, the subject matter of any one or more of examples 19-21 optionally includes a tissue retrieval device configured to extend through the at least one channel.

Example 23 is the modular endoscope system of example 1, further comprising a duodenal mirror having a working channel into which the imaging guidewire and the accessory can be simultaneously assembled.

Example 24 is a method of providing medical intervention to an internal anatomical location, the method comprising: inserting an imaging guidewire into the anatomic passageway; viewing the target anatomy using the imaging function of the imaging guidewire; pushing the intervention accessory along the imaging guidewire to the target anatomy; and operating the intervention accessory to provide intervention to the target anatomy.

In example 25, the subject matter of example 24 optionally includes determining the intervention action intraoperatively by viewing the target anatomy using an imaging function of the imaging guidewire.

In example 26, the subject matter of example 25 optionally includes wherein the intervention accessory is selected based on the determined intervention action.

In example 27, the subject matter of example 26 optionally includes, wherein the intervention action comprises opening a sphincter in the internal anatomical location.

In example 28, the subject matter of example 27 optionally includes opening the sphincter with a stent comprising an intervention accessory.

In example 29, the subject matter of any one or more of examples 24-28 optionally includes, wherein pushing the intervention accessory along the imaging guidewire to the target anatomy comprises: the interventional accessory is positioned around the imaging guidewire.

In example 30, the subject matter of any one or more of examples 26 to 29 optionally includes, wherein the intervention action comprises transferring biological material.

In example 31, the subject matter of example 30 optionally includes disrupting the biological material with a laser lithotripter including an intervention accessory.

In example 32, the subject matter of any one or more of examples 30-31 optionally includes removing the biological material with a tissue removal device that includes an intervention accessory.

In example 33, the subject matter of any one or more of examples 30 to 32 optionally includes flushing the target anatomy with the intervention accessory.

In example 34, the subject matter of any one or more of examples 30-33 optionally includes, wherein pushing the intervention accessory along the imaging guidewire to the target anatomy comprises: the intervention accessory is slid along the sliding feature of the imaging guidewire.

In example 35, the subject matter of example 34 optionally includes preventing radial and circumferential displacement of the intervention accessory relative to the imaging guidewire having the sliding feature.

In example 36, the subject matter of any one or more of examples 34-35 optionally includes, wherein the sliding feature of the imaging guidewire includes a slot, and the intervention accessory includes a rail configured to mate with the slot.

In example 37, the subject matter of example 36 optionally includes wherein the rail and the slot have complementary T-shaped profiles.

In example 38, the subject matter of any one or more of examples 34-37 optionally includes preventing the intervention accessory from sliding off the imaging guidewire with a stop.

In example 39, the subject matter of any one or more of examples 24-38 optionally includes, wherein inserting the imaging guidewire into the anatomical passageway comprises: an imaging guidewire is inserted through the working channel of the duodenal scope.

In example 40, the subject matter of example 39 optionally includes, wherein pushing the intervention accessory along the imaging guidewire to the target anatomy comprises: the intervention accessory is pushed through the working channel of the duodenal mirror.

In example 41, the subject matter of any one or more of examples 24-40 optionally includes, wherein inserting the imaging guidewire into the anatomical passageway comprises: the cover of the imaging guidewire is pushed through the anatomy to shield the imaging function.

In example 42, the subject matter of any one or more of examples 24-41 optionally includes, wherein viewing the target anatomy with the imaging functionality of the imaging guidewire includes: the target anatomy is viewed from the distal end of the imaging guidewire.

In example 43, the subject matter of any one or more of examples 24 to 42 optionally includes, wherein viewing the target anatomy with the imaging functionality of the imaging guidewire includes: illuminating the target anatomy with an illumination device; and capturing an image of the target anatomy with a camera device.

Each of these non-limiting examples may exist independently or may be combined with one or more of the other examples in various permutations or combinations.

Various notes

The foregoing detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples". These examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the inventors contemplate examples using any combination or permutation of those elements (or one or more aspects thereof) shown or described with respect to a particular example (or one or more aspects thereof) or with respect to other examples (or one or more aspects thereof) shown or described herein.

If the usage between this document and any document incorporated by reference is inconsistent, the usage in this document controls.

In this document, the terms "a" or "an" are used to include one or more than one, irrespective of any other examples or usage of "at least one" or "one or more", as is common in the patent literature, unless otherwise indicated. In this document, the term "or" is used to refer to non-exclusive or such that "a or B" includes "a but not B", "B but not a" and "a and B", unless otherwise indicated. In this document, the terms "comprise" and "wherein" are used as the pure english equivalents of the respective terms "comprising" and "wherein". Furthermore, in the following claims, the terms "comprises" and "comprising" are open-ended, i.e., a system, device, article, composition, formulation, or process that includes elements other than those listed after the term in the claim is still considered to fall within the scope of the claim. Furthermore, in the following claims, the terms "first," "second," and "third," etc. are used merely as labels, and are not intended to impose labeling requirements on their objects.

The method examples described herein may be at least partially machine or computer implemented. Some examples may include a computer-readable medium or a machine-readable medium encoded with instructions operable to configure an electronic device to perform a method as described in the examples above. Implementations of such methods may include code, such as microcode, assembly language code, higher-level language code, and the like. Such code may include computer readable instructions for performing various methods. The code may form part of a computer surgical product. Furthermore, in examples, the code may be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of such tangible computer-readable media may include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., optical disks and digital video disks), magnetic tapes, memory cards or sticks, random Access Memories (RAMs), read Only Memories (ROMs), and the like.

The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments may be used, such as by one of ordinary skill in the art upon reading the above description. The abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Furthermore, in the foregoing detailed description, various features may be grouped together to simplify the present disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, the inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the detailed description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that: these embodiments may be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claim (modification according to treaty 19)

1. A modular endoscope system, the modular endoscope system comprising:

An imaging guidewire, the imaging guidewire comprising:

an elongate shaft extending from a proximal end to a distal end;

An imaging device located near the distal end of the elongate shaft; and

An illumination element positioned near the distal end of the elongate shaft,

Wherein the illumination elements are arranged in an arcuate configuration to at least partially surround the imaging device; and

An intervention accessory configured to slide on the elongate shaft to provide a medical intervention, wherein the intervention accessory comprises an elongate housing having at least one channel extending at least partially therethrough.

2. The modular endoscope system of claim 1, further comprising a cover at a distal end of the elongate shaft, wherein the cover is tapered to push anatomical structures away from the imaging device and the cover is transparent such that the imaging device can be viewed through the cover.

3. The modular endoscope system of claim 1, wherein the illumination element comprises a hollow fiber surrounding the imaging device.

4. The modular endoscope system of claim 1, wherein the illumination element comprises a plurality of light emitters.

5. The modular endoscope system of claim 4, wherein the illumination element comprises a plurality of optical fibers arranged in an annular shape, and the imaging device comprises an imaging microchip positioned within the annular shape.

6. The modular endoscope system of claim 1, wherein the elongate shaft has an outer contoured shape and the imaging device and the illumination element are located within the outer contoured shape.

7. The modular endoscope system of claim 6, wherein the outer contoured shape is circular and the outer contoured shape has a diameter in a range of about 0.8mm to about 3.0 mm.

8. The modular endoscope system of claim 7, wherein a combined outer diameter of the imaging guidewire and the intervention accessory is no more than about 5.0mm.

9. The modular endoscope system of claim 6, further comprising a sliding feature extending along at least a portion of the elongate shaft between the proximal end and the distal end.

10. The modular endoscope system of claim 9, wherein the sliding feature comprises a slot configured to receive a mating rail.

11. The modular endoscope system of claim 10, wherein the slot is located within the outer contoured shape.

12. The modular endoscope system of claim 10, wherein the slot comprises a radial detent.

13. The modular endoscope system of claim 12, wherein the slot has a T-shape.

14. The modular endoscope system of claim 9, wherein the sliding feature comprises a distal stop.

15. The modular endoscope system of claim 9, wherein the intervention accessory is configured to slide on the sliding structure and not connect with the sliding feature.

16. The modular endoscope system of claim 15, wherein the intervention accessory comprises:

A bracket configured to fit around the elongate shaft; and

An insertion shaft including the elongate housing and configured to position the stent along the elongate shaft.

17. The modular endoscope system of claim 1, wherein the intervention accessory comprises one or more pull wires extending through the elongate housing.

18. The modular endoscope system of claim 9, further comprising a second intervention accessory configured to slide along and connect to the sliding feature.

19. The modular endoscope system of claim 1, wherein the at least one channel extends through the elongated housing and is offset from a central axis of the elongated housing.

20. The modular endoscope system of claim 1, wherein the elongated housing further comprises a laser fiber extending at least partially through the elongated housing.

21. The modular endoscope system of claim 1, wherein the elongate housing further comprises a flushing channel configured to deliver fluid through the elongate housing.

22. The modular endoscope system of claim 1, further comprising a tissue retrieval device configured to extend through the at least one channel.

23. The modular endoscope system of claim 1, further comprising a duodenal scope having a working channel into which the imaging guidewire and the intervention accessory are simultaneously fittable.

24. A method of providing medical intervention to an internal anatomical location, the method comprising:

Inserting an imaging guidewire into the anatomic passageway;

Using the imaging function of the imaging guidewire to view a target anatomy;

Pushing an intervention accessory along the imaging guidewire to the target anatomy; and

The intervention accessory is operated to provide an intervention to the target anatomy.

25. The method of claim 24, the method further comprising: an intervention action is determined intraoperatively by viewing the target anatomy with the imaging functionality of the imaging guidewire.

26. The method of claim 25, wherein the intervention accessory is selected based on the determined intervention action.

27. The method of claim 26, wherein the intervention action comprises: opening the sphincter in the internal anatomical location.

28. The method of claim 27, the method further comprising: opening the sphincter using a stent comprising the intervention accessory.

29. The method of claim 24, wherein pushing the intervention accessory along the imaging guidewire to the target anatomy comprises:

positioning the intervention accessory around the imaging guidewire.

30. The method of claim 26, wherein the intervention action comprises: transferring the biological material.

31. The method of claim 30, the method further comprising: breaking the biological material with a laser lithotripter comprising the intervention accessory.

32. The method of claim 30, the method further comprising: the biological material is removed with a tissue removal device comprising the intervention accessory.

33. The method of claim 30, the method further comprising: the target anatomy is irrigated with the intervention accessory.

34. The method of claim 30, wherein pushing the intervention accessory along the imaging guidewire to the target anatomy comprises:

Sliding the intervention accessory along a sliding feature of the imaging guidewire.

35. The method of claim 34, the method further comprising: the sliding feature is utilized to prevent radial and circumferential displacement of the intervention accessory relative to the imaging guidewire.

36. The method of claim 34, wherein the sliding feature of the imaging guidewire comprises a slot and the intervention accessory comprises a rail configured to mate with the slot.

37. The method of claim 36, wherein the rail and the slot have complementary T-shaped profiles.

38. The method of claim 34, the method further comprising: a stop is utilized to prevent the interventional accessory from sliding off the imaging guidewire.

39. The method of claim 24, wherein inserting the imaging guidewire into the anatomic passageway comprises: the imaging guidewire is inserted through the working channel of the duodenal mirror.

40. The method of claim 39, wherein pushing the intervention accessory along the imaging guidewire to the target anatomy comprises: pushing the intervention accessory through the working channel of the duodenal mirror.

41. The method of claim 24, wherein inserting the imaging guidewire into the anatomic passageway comprises: a cover of the imaging guidewire is pushed through the anatomical structure to shield the imaging function.

42. The method of claim 24, wherein utilizing the imaging function of the imaging guidewire to view a target anatomy comprises:

the target anatomy is viewed from the distal end of the imaging guidewire.

43. The method of claim 24, wherein utilizing the imaging function of the imaging guidewire to view the target anatomy comprises:

illuminating the target anatomy with an illumination device; and

An image of the target anatomy is captured with a camera device.

Claims

1. A modular endoscope system, the modular endoscope system comprising:

An imaging guidewire, the imaging guidewire comprising:

an elongate shaft extending from a proximal end to a distal end;

An imaging device located near the distal end of the elongate shaft; and

An illumination element positioned adjacent the distal end of the elongate shaft, an

An intervention accessory configured to slide along the elongate shaft to provide a medical intervention.

2. The modular endoscope system of claim 1, further comprising a cap at a distal end of the elongate shaft, wherein the cap is tapered to push anatomical structures away from the imaging device.

3. The modular endoscope system of claim 2, wherein the cover is transparent and positioned such that the imaging device can be viewed through the cover.

5. The modular endoscope system of claim 4, wherein the illumination element comprises an annular shape and the imaging device is positioned within the annular shape.

11. The modular endoscope system of claim 10, wherein the slot is located within an outer contoured shape.

13. The modular endoscope system of claim 12, wherein the slot has a T-shape.

15. The modular endoscope system of claim 9, wherein the intervention accessory is configured to slide over and not connect with the sliding feature.

16. The modular endoscope system of claim 15, wherein the intervention accessory comprises a bracket configured to fit around the elongate shaft.

17. The modular endoscope system of claim 16, wherein the bracket comprises an insertion shaft configured to position the bracket along the elongate shaft.

18. The modular endoscope system of claim 9, wherein the intervention accessory is configured to slide along and connect to the sliding feature.

19. The modular endoscope system of claim 1, wherein the intervention accessory comprises an elongated housing having at least one channel extending at least partially therethrough.

20. The modular endoscope system of claim 19, wherein the elongated housing further comprises a laser fiber extending at least partially through the elongated housing.

21. The modular endoscope system of claim 19, wherein the elongate housing further comprises a flushing channel configured to deliver fluid through the elongate housing.

22. The modular endoscope system of claim 19, further comprising a tissue retrieval device configured to extend through the at least one channel.

23. The modular endoscope system of claim 1, further comprising a duodenal mirror having a working channel into which the imaging guidewire and the intervention accessory are simultaneously fittable.

Inserting an imaging guidewire into the anatomic passageway;

Viewing a target anatomy using an imaging function of the imaging guidewire;

positioning the intervention accessory around the imaging guidewire.

36. The method of claim 34, wherein the sliding feature of the imaging guidewire comprises a slot and the intervention accessory comprises a guide rail configured to mate with the slot.

42. The method of claim 24, wherein utilizing an imaging function of the imaging guidewire to view a target anatomy comprises:

the target anatomy is viewed from the distal end of the imaging guidewire.

43. The method of claim 24, wherein utilizing an imaging function of the imaging guidewire to view the target anatomy comprises:

illuminating the target anatomy with an illumination device; and

An image of the target anatomy is captured with a camera device.