Endoscopic devices, systems, and methods

Abstract

The endoscopic device comprises a wall defining an interior space, a working channel within or defined by the interior space, and at least one optical fiber embedded or otherwise provided in the wall, the endoscopic device having an outer diameter of less than 2.5 mm.

Description

[Technical field]

[0001] Introduction The present invention relates to endoscopic devices, systems, and methods. [Background technology]

[0002] It is known to provide medical endoscopic devices that incorporate an optical biopsy fiber and a working channel that serves to provide imaging or sensing data while positioned relative to the working channel so that a medical device can be inserted through the working channel during surgery. Currently available devices generally have a distal outer diameter greater than 2 millimeters.

[0003] There is a need for a disposable, cost-effective medical endoscopic device that is highly flexible and has a distal outer diameter of 2 millimeters or less to enable non-invasive and atraumatic access to difficult to reach portions of the anatomy, such as the distal lung.

[0004] It is known to provide miniaturized fiber optic bundles that can be fed into conventional bronchoscopes, but do not have working channels for solid objects, such as diagnostic and therapeutic tools.

[0005] Olympus manufactures bronchoscopes that include devices with an outer diameter of approximately 3 millimeters that use peripheral optical devices such as lenses at the distal end.

[0006] JP2008 / 200098A discloses a non-disposable optical coherence tomography (OCT) fiber provided in a sheath wall for use in a biopsy procedure in a small lumen, the OCT portion of the sheath being capable of sliding.

[0007] US8333691B2 describes a flexible multi-lumen catheter probe having multiple fibres and working channels, as well as separate illumination and imaging systems and fibres. The flexible catheter probe is a disposable and injection moulded or extruded component.

[0008] EP1948056A2 describes a catheter containing a fiber optic probe for sensing the environment at the catheter tip. The optical fiber has a distal end for illuminating and receiving light energy from tissue.

[0009] US5419312 describes a multi-functional multi-fiber endoscope.

[0010] US6458076B1 describes a multi-lumen flexible endoscope in which the multi-lumen shaft has an outer diameter of 6mm or less and in which separate illumination fibers are used. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] JP2008 / 200098A [Patent Document 2] US8333691B2 [Patent Document 3] EP1948056A2 [Patent Document 4] US5419312 [Patent Document 5] US6458076B1 [Patent Document 6] WO2017 / 0158331 [Patent Document 7] WO2017 / 174998 [Patent Document 8] WO2017 / 149310 [Patent Document 9] WO2018 / 007829 [Patent Document 10] WO2017 / 203272 [Patent Document 11] WO2018 / 134622 [Patent Document 12] WO2018 / 203088 [Patent Document 13] WO2019 / 138220 [Patent Document 14] WO2019 / 243760 [Patent Document 15] WO2022 / 034055 [Non-patent literature]

[0012] [Non-Patent Document 1] https: / / arxiv.org / abs / 2012.08836 https: / / onlinelibrary.wiley.com / doi / full / 10.1002 / jbio.202000488 https: / / proteus.ac.uk / technology / fibre-bundle / [Non-Patent Document 2] https: / / link.springer.eom / article / 10.1007 / s00259-020-05021-4 [Non-Patent Document 3] https: / / www.olympus-europa.com / medical / rmt / media / en / Content / Content- MSD / Documents / Brochures / SRP-Periphery / E0428337EN_EEIII_BF- MP190_A4_EN.pdf [Non-Patent Document 4] https: / / erj.ersjournals.eom / content / 32 / 2 / 465 (“Novel thin bronchoscope with a 1.7-mm working channel for peripheral pulmonary lesions”) Summary of the Invention [Means for solving the problem]

[0013] In a first aspect, there is provided an endoscopic device comprising a wall defining an interior space, a working channel within or defined by the interior space, and at least one optical fiber, optionally at least one optical imaging fiber embedded or otherwise provided in the wall, the endoscopic device having an outer diameter of less than 2.5 mm, optionally 2 mm or less. The at least one optical fiber may include at least one optical imaging fiber and / or at least one optical sensing fiber.

[0014] The walls may comprise a plastic material and / or a heat shrink material.

[0015] The plastic material and / or the heat shrink material may have been subjected to a plastic processing method, optionally at least one of a heat shrink process, a plastic welding process, an injection molding process, and / or an extrusion process. Embedding or otherwise providing the at least one optical fiber in the wall may include gluing the at least one optical fiber to at least a portion of the wall. Embedding may include embedding within the material of the wall.

[0016] The heat shrink material may include a biocompatible material. The heat shrink material may include at least one of Pebax heat shrink, PET, FEP, or PTFE heat shrink material. The heat shrink material may form an exterior surface of the device. The heat shrink material may be peeled or otherwise removed from the device after the heat shrink process is performed.

[0017] The at least one optical fiber may include optical imaging fiber(s) configured to both provide illumination to the target area at a distal end of the fiber(s) and receive light from the target area, as well as transmit the received light from the distal end of the fiber(s) to the proximal end of the fiber.

[0018] The or each optical fiber may comprise an optical imaging fiber having an outer diameter in the range 0.1 mm to 1.0 mm, optionally in the range 0.2 mm to 0.5 mm.

[0019] The or each optical fibre may comprise a sensing fibre, optionally a single core fluorescent sensing fibre, and may have an outer diameter in the range 0.01mm to 1.0mm, for example an outer diameter of 0.04mm.

[0020] The optical fiber, or one or more or each of the optical fibers, may include a single core or may include multiple cores. A regular array of the cores may be provided, surrounded and / or separated by a cladding. The cores may include doped silica, for example fluorine doped silica or germanium doped silica. The cladding may include silica, for example pure silica.

[0021] The end face of the or each optical fiber and / or the core(s) of the optical fiber may be substantially flat and / or may be free of optical components.

[0022] At least one optical fiber may be embedded in the wall over an embedment length that includes at least 50% or at least 80% of the length of the wall, and / or at least 50% or at least 80% of the length of the optical fiber, and / or at least one optical fiber may be embedded in the wall over an embedment length that is at least 15 cm, optionally at least 30 cm, optionally at least 50 cm.

[0023] Both the wall and the optical fiber can be flexible. The optical fiber can be embedded such that when bent, the wall and the optical fiber remain in contact over the entire embedded length.

[0024] The at least one optical fiber may include optical fibers from a fiber bundle configured in combination to provide imaging.

[0025] The at least one optical fiber may be configured to perform at least one of wide-field imaging, confocal imaging, and / or fluorescence imaging.

[0026] The at least one optical fiber can be positioned relative to the working channel such that a medical device inserted through the working channel can access an area that is illuminated and / or imaged using the at least one optical fiber during surgery.

[0027] The working channel may include a liner.

[0028] The liner may be formed of polytetrafluoroethylene (PTFE), polyimide, FEP, or other polymeric materials.

[0029] The working channel can be configured to receive at least one medical device, optionally a therapeutic, surgical or diagnostic tool, and / or a sensing device.

[0030] The working channel may have an inner diameter of less than 1.8 mm, optionally no more than 1.5 mm, optionally no more than 1.2 mm, optionally no more than 1 mm.

[0031] The device may further comprise at least one sensing fiber, also embedded or otherwise provided in the wall.

[0032] The at least one sensing fiber may include a fiber for use in performing spectroscopy, optionally Raman spectroscopy.

[0033] The wall may have a thickness that varies, optionally continuously varies, around the periphery of the wall.

[0034] The at least one optical fiber may be located in the thickest portion of the wall.

[0035] The thickest portion of the wall may include one-half, one-third, one-quarter, or one-eighth of the periphery where the wall has its highest average thickness.

[0036] The device may be a disposable device, optionally a single-use disposable device.

[0037] The optical fiber may be connectable at a proximal end to an endoscopic imaging device including a light source configured to input light into at least one optical imaging fiber at the proximal end and a light detector configured to detect light transmitted from the distal end to the proximal end of the at least one imaging fiber.

[0038] In a further aspect that may be provided independently, a method of forming an endoscopic device is provided, the method including inserting at least one optical fiber, optionally at least one optical imaging fiber, into a tube of material and performing a process to at least partially embed or otherwise provide the at least one optical fiber in a wall of the tube.

[0039] The process may include at least one of a plastic processing method, a heat shrink process, a plastic welding process, an injection molding process, and / or an extrusion process. The process may include adhering the optical fiber to at least a portion of the wall.

[0040] The method may further include providing a mandrel within the tube and removing the mandrel from the tube, thereby forming a working channel in the device.

[0041] The mandrel may include a liner and removal of the mandrel may include leaving the liner within the tube to form the walls of the working channel.

[0042] The endoscopic devices formed may include any device claimed or described herein.

[0043] In a further aspect, an endoscopic system is provided comprising a device as claimed or described herein and an endoscopic apparatus including a light source configured to input light into at least one optical imaging fiber at a proximal end and a light detector configured to detect light transmitted from a distal end to a proximal end of the at least one imaging fiber.

[0044] In another aspect, a method is provided for imaging a region of a subject, the method including inserting into the subject a device as claimed or described herein, transmitting light from a light source through at least one optical fiber to the region of the subject, and detecting light received from the region of the subject at a proximal end of the at least one optical fiber.

[0045] In another aspect, an endoscopic device may be provided having a working channel, an imaging channel, and possibly multiple optical fibers that use the same optical fiber for light illumination and collection. The device may be configured to perform fluorescent endoscopic imaging and / or any suitable zero working distance imaging technique to avoid the need for a distal optical device. The optical fiber may be embedded in the wall of the working channel, and the working channel may be used to insert a second medical device to access the area under investigation for diagnosis and treatment. The second medical device may be guided to the identified suspicious tissue area while maintaining clear identification of the area using the optical fiber. The device may be formed using a heat shrink process that embeds the optical fiber in the wall of the working channel, thus providing both flexibility and a sub-2 millimeter outer diameter.

[0046] In another aspect, an endoscopic probe is provided that provides targeted diagnosis and therapy to the distal lung. The probe may include an optical fiber for fluorescence endoscopy configured to provide sufficient information to identify tissue regions of interest (e.g., cancerous lesions) and an adjacent working channel with an inner diameter of 1.2 millimeters or less. The tool may have an outer diameter of less than 2.5 millimeters, optionally 2 millimeters or less, allowing non-invasive and non-traumatic access to the distal lung. The use of a fluorescence endoscope may enable zero working distance imaging techniques that avoid the need for distal optics and electronics. This may be accomplished, for example, by using the same optical fiber for both illumination and light collection, avoiding the need for distal optics and electronics, and integrating both the working channel and the optics into a monolithic device.

[0047] The probe may provide or be used to provide a method of preliminary diagnosis of a suspicious tissue area for investigation, and may provide or be used to provide a method of directing additional diagnostic or therapeutic tools to an identified suspicious tissue area while maintaining a clear identification using a diagnostic method. The method of encapsulating the fiber may use heat shrink lamination technology and biocompatible polymers. One or more optical fibers may be embedded in the wall by heat shrink lamination technology. The probe may be disposable and configured for single use, for example, by using industrially available materials and methods. Providing a single-use disposable flexible bronchoscope may help avoid cross contamination and increase resource utilization.

[0048] In another aspect, a micro-endoscopic probe is provided for providing targeted diagnostics and therapy to the distal lung. The probe may include optical fibers for fluorescence endoscopy, optical sensing fibers for sensing for use in performing spectroscopy, and an adjacent working channel with an inner diameter of 1.2 millimeters or less. The tool may have an outer diameter of 2 millimeters or less to allow non-invasive and atraumatic access to the distal lung. The walls of the channel may have a thickness that varies around its periphery. At least one of the optical fibers may be located in the thickest portion of the wall.

[0049] In another aspect, a method of preliminary diagnosis of suspicious tissue regions for investigation is provided, allowing access to hard-to-reach regions of the human body (such as the distal lung). The structure may be such as to allow single-use disposability to improve clinical throughput and simplicity. A disposable and minimally invasive device may be provided that allows for targeted diagnosis and treatment of the distal lung. The device and / or system may be configured to perform any one or more of a number of spectroscopic methods of tissue characterization coupled with a working channel. The working channel may allow access to the same tissue site being imaged with other diagnostic or therapeutic tools while maintaining clear identification.

[0050] The devices can provide or be used as diagnostic and therapeutic tools for clinicians to perform preliminary diagnostic and therapeutic procedures in vivo, for example, to provide cellular resolution imaging in real time to speed up clinical workflow and minimize patient harm.

[0051] It is envisioned that the device may also be adapted to fit other organs and tissues by including other sensing or imaging fibers and devices, capillaries for fluid delivery and extraction, or micromechanical tools. Other organs may have more stringent outer diameter requirements, but in some embodiments, by omitting the imaging fiber, the device may be made thinner than a millimeter, for example, while still providing a full set of chemically specific spectra or other desired spectroscopic functions.

[0052] The method of encapsulating the fiber can be to use heat shrink lamination techniques to mold a biocompatible tube around the optical (imaging) fiber and a removable mandrel and polytetrafluoroethylene (PTFE) liner to form the working channel. The fiber can be encapsulated in a polymer along its entire length. The heat shrink can be made of Pebax, polyethylene terephthalate (PET), fluorinated ethylene propylene (FEP), PET, or other suitable materials.

[0053] Features in one aspect may be applied as features in any other aspect in any suitable combination, for example, features of any one or more of the device, system, probe, or method aspects may be applied as features of any one or more of the other device, system, probe, or method aspects.

[0054] Various embodiments will now be described, by way of example only, with reference to the accompanying drawings in which: [Brief description of the drawings]

[0055] [Figure 1] 13 is an image of the device with a plastic splitter separating the imaging fiber and the working channel. [Diagram 2] 13 is an image of the distal head of the device with an optical imaging fiber integrated into its wall. [Diagram 3] FIG. 1 is a schematic diagram showing an optical imaging fiber of the device connected to an imaging apparatus. [Figure 4] 13 is an image of the distal head of a probe having an optical imaging fiber and an optical sensing fiber integrated into its wall. [Diagram 5] FIG. 13 is an image of the distal head of the probe with the optical imaging fiber encapsulated in hardness gauge Pebax. [Figure 6] 13 is an image of a catheter with a biopsy forceps emerging from the distal end of the working channel and illuminated from the distal end of the imaging fiber. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0056] The device according to one embodiment combines an optical biopsy diagnostic fiber capable of identifying suspicious tissue region(s) or other region(s) of interest while maintaining clear identification with a working channel that allows access to the same region(s). The working channel can allow for further additional diagnostic, therapeutic or other tools to be deployed in real time to the identified suspicious tissue region. The device is flexible and has a sub-2.5 mm, optionally sub-2 mm diameter, allowing minimally invasive non-surgical access to hard to reach regions of the body (such as distal bronchioles) while minimizing patient stress and providing highly targeted therapeutic and optical biopsy. In various embodiments, the optical imaging fiber has an outer diameter in the range of 0.1-1 mm, optionally in the range of 0.2-0.5 mm.

[0057] The optical imaging or sensing fiber may include a single core surrounded by a cladding, or an array of cores surrounded by a cladding. The cores may be a regular array of germanium doped silica cores surrounded and separated by a pure silica glass cladding. In other embodiments, fluorine doped silica may be used for the cladding. The optical imaging fiber may be comprised of a fiber bundle configured in combination to provide imaging. The optical sensing fiber may be comprised of a fiber bundle configured in combination to provide sensing. Any suitable imaging, sensing, and / or spectroscopy procedure may be performed using the fiber(s), for example, fluorescence imaging and / or Raman spectroscopy.

[0058] The device uses a single imaging fiber (at the distal end) without additional optics by using the same optical fiber for both illumination and light collection. This allows the probe to have a smaller distal cross-sectional size (less than 2 millimeters) and flexibility. Using the imaging fiber, the probe can provide a suitable method of preliminary diagnosis of suspicious tissue areas for investigation, and through its working channel provides a method of directing additional diagnostic or therapeutic tools to the identified suspicious tissue area while maintaining a clear identification using the diagnostic method.

[0059] In some embodiments, a method of forming the device that includes encapsulating the fiber in a biocompatible polymer along the entire fiber length can impart device properties of strength, kink resistance, and flexibility. The device construction is such that it can be cost effective enough to allow disposal after a single use. Heat shrinking can form the exterior surface of the device.

[0060] FIG. 1 is an image of a device in the form of a probe 10 according to one embodiment, showing the outer wall 16 of the device in an interior space in which a working channel 14 is provided, an optical imaging fiber 12 embedded in the wall 16, and a plastic splitter 15 separating the imaging fiber 12 and the wall 16 of the device at the proximal end of the device 10. The imaging fiber 12 is located within the wall 16 of the device 10 along its length, all the way from the splitter 15 to the distal end of the device 10. The splitter 15 helps protect the fiber 12 at the point where it exits the wall 16 of the device to reduce the possibility of mechanical damage during use. In this embodiment, the distal end of the imaging fiber 12 is fixed to the distal end of the device using epoxy, but is free inside the wall 16 along its length. In other embodiments, epoxy can fix the imaging fiber 12 along all or most of the length of the device. In other embodiments, any other suitable adhesive can be used instead of epoxy.

[0061] In the embodiment shown in Figure 1, a secondary optical device 18 is inserted into the working channel 14. The secondary optical device 18 is shown in Figure 1 emerging from the distal end of the working channel 14. A steel distal cap may be provided on the distal end of the secondary optical device 18 inserted into the working channel. The device 10 may be capped using polyimide tubing and epoxy.

[0062] It will be appreciated that in FIG. 1, the endoscopic device 10 is bent upon itself so that the distal end and the proximal region can be shown in the same image.

[0063] The space between the working channel 14 and around the optical imaging fiber 12 surrounded by a wall 16 made of a biocompatible polymer can be sealed with, for example, epoxy. In other embodiments, the epoxy can fill less than the length of the working channel 14 and / or the space between the working channel 14 and the wall 16.

[0064] FIG. 2 is a head-on image of the distal head of the probe 10 of FIG. 1, showing the optical imaging fiber 12 embedded in the wall 16 of the probe. The probe 10 has an outer diameter of 2 millimeters, and the optical imaging fiber 12 has a diameter of 0.45 millimeters. The inner diameter of the working channel 14 is 1.2 millimeters. The optical imaging fiber 12, and / or the core of the fiber, is substantially flat at its distal end face and does not include any optical components. The embodiment shown includes an outer layer and an inner layer of polyimide, with the imaging fiber 12 between the two layers. The remaining space between the inner and outer layers of polyimide is filled with epoxy 13 over at least a portion of the length of the working channel or wall. In other embodiments, the remaining space between the inner and outer layers of polyimide is partially filled with epoxy. The inner layer of polyimide forms the boundary of the working channel 14. Thus, the probe 10 is formed with an outer layer of polyimide tubing, epoxy 13, fiber 12, and an inner layer of polyimide that creates the working channel 14. The walls are formed from a combination of inner and outer layers of polyimide and epoxy 13. Polyimide as used in this embodiment is not heat shrinkable.

[0065] Any suitable therapeutic, surgical, or diagnostic tool, and / or sensing device can be inserted into working channel 14. In some embodiments, the working channel may have an inner diameter of, for example, less than 1.8 millimeters, optionally 1.5 millimeters or less, optionally 1.2 millimeters or less, optionally 1 millimeter or less. The working channel may have a minimum diameter of, for example, 0.5 mm. In the embodiment of FIG. 1, the working channel has a diameter of 1.2 mm, the imaging fiber has a diameter of 0.2 mm, and the probe 10 has a diameter of 2.0 mm.

[0066] In the device of FIG. 1, the optical imaging fiber was fabricated using two types of stock glasses: undoped silica tubes and rods, and germanium-doped silica. The undoped silica tubes and rods were Superasil F300 (Heraeus), and the germanium-doped silica was from an OM1 preform with a core-to-cladding ratio of 0.75, a parabolic refractive index profile, and a peak numerical aperture of 0.3 (Draka, Prysmian). Both materials are mass-produced for the telecommunications industry, allowing the device to be cost-effective enough for a single use, after which it is disposable. The optical imaging fiber was produced using known heating and drawing techniques to produce an imaging fiber containing multiple cores. Any suitable optical fiber, either single-core or multi-core, and produced using any suitable technique, can be used in other embodiments.

[0067] In use, the optical imaging fiber 12 and / or the core(s) of the fiber(s) may be connected to an optical device at the proximal end and may be substantially flat at its end face. The optical device may include an endoscopic imaging device including a light source configured to input light into at least one optical imaging fiber 12 at the proximal end of the device. The light source may be, for example, a light emitting diode (LED). In other embodiments, the light source may be a laser. The imaging device may also include a photodetector configured to detect light transmitted from the distal end to the proximal end of the at least one imaging fiber. The optical fiber is configured to transmit light in both directions along its length. This provides illumination to a target at the distal end of the fiber. The optical fiber also receives light from the target area and transmits light from the distal end of the fiber to the proximal end of the fiber.

[0068] 3 is a schematic diagram of an imaging device 60 that can be connected to the imaging fiber 12 in one mode of operation. The imaging device 60 comprises a laser scanning unit 66, a sensor unit 67, and a processing device 68. The laser scanning unit 66 is a proximal laser scanning unit coupled to the interface with the multi-core optical fiber 12.

[0069] The optical fiber 12 and the laser scanning unit 66 are configured to perform optical endoscopic imaging, also referred to as optical endoscope (OEM), at the distal end of the optical fiber 12. In this embodiment, the light source is a laser light source having a wavelength of 450 nm or less. In other embodiments, a light emitting diode (LED) having a wavelength of 450 nm or less can be used. Also, in embodiments where LEDs are used as the light source, wide-field illumination can be used for imaging. In this embodiment, the image is acquired using an optical endoscope, but in other embodiments, any suitable method of acquiring images or other information may be used. In some embodiments, the device may be configured to perform Raman spectroscopy. For embodiments using Raman spectroscopy, a laser light source having a wavelength in the range of 532 nm to 785 nm and / or 850 nm to 1064 nm may be used. In some embodiments, wide-field illumination may be used simultaneously with OEM or Raman spectroscopy. In some embodiments, a supercontinuous laser light source may be used for the light source.

[0070] The imaging device 60 is used to obtain images of the distal lung. In other embodiments, the endoscopic device 10 can be used to position the optical fiber 12 at any suitable anatomical location in any human or animal subject. For example, the device 10 can be used to generate frame sequences or other images when navigating along the respiratory tree, bronchioles, urinary tract or digestive tract, or when navigating in laparoscopy, colonoscopy, biliary tree endoscopy, wireless capsule endoscopy, or laryngoscopy.

[0071] The laser scanning unit 66 is configured to transmit laser light into the optical fiber 12 to the distal lung. The light from the laser scanning unit 66 can generate autofluorescence in the lung and / or can cause fluorescence of a fluorescent substance that has been introduced into the lung. In some embodiments, a dye is added to the lung. The dye is configured to fluoresce when excited with appropriate light from the laser scanning unit 66.

[0072] The fluorescent light generated in the distal lung passes through the optical fiber and is received by the sensor unit 67. The sensor unit 67 converts the received light into an electrical signal. The sensor unit houses collection optics as well as a detector. The collection optics may include one or more of filters, lenses, reformatters, and mirrors, or any other suitable optical device. The detector may include, for example, a spectrometer, a single photon detector, or a charge-coupled device (CCD) chip. In an embodiment, the single photon detector is typically implemented using an avalanche diode. The sensor unit 67 passes the electrical signal to a processing device 68. The processing device 68 may include any suitable computing device, for example, a desktop or laptop computer, or a mobile device, or any suitable processor, or combination of processors, or ASICS, FPGA, or other circuitry. In further embodiments, the laser scanning unit 66, the sensor unit 67, and the processing device 68 may be replaced by one combined device. The functions described as being performed by the laser scanning unit 66 and the sensor unit 67 may be performed by the processing unit 18, or vice versa.

[0073] The processing unit 68 is configured to process the electrical signals received from the sensor unit 67 to obtain a frame sequence including a plurality of image frames. In this embodiment, the electrical signals represent light received from the individual cores of the fiber 12. The processing unit 68 combines the signals from the different cores to form each frame of the frame sequence. The processing unit 68 can obtain a series of image frames in which image effects caused by the individual cores of the fiber 12 are removed. The frame sequence, or other images obtained using the optical imaging fiber 12, can be displayed in real time such that an area of ​​a patient or other subject can be viewed while a procedure is performed on at least a portion of the area using a tool inserted through the working channel.

[0074] In other embodiments, any other suitable imaging device, or selected components thereof, may be used, e.g., light sources, detectors, optical components, and / or processors, as appropriate, for example, imaging devices or components of such devices, e.g., light sources, detectors, optical components, and / or processors, as described in any of WO2017 / 0158331, WO2017 / 174998, WO2017 / 149310, WO2018 / 007829, WO2017 / 203272, WO2018 / 134622, WO2018 / 203088, WO2019 / 138220, WO2019 / 243760, or WO2022 / 034055, each of which is incorporated herein by reference. The imaging device may be configured to perform any suitable type of imaging, e.g., wide-field imaging, confocal imaging, and / or fluorescence imaging, e.g., using any suitable known technology.

[0075] FIG. 4 is an image of the distal head of device 100 in a further embodiment. Device 100 is in the form of an endoscopic probe, comprising an optical imaging fiber 12, for example as described in relation to FIG. 1, and a further optical sensing fiber 30, both of which are embedded in the wall 116 of the probe. A working channel 114 is also shown. The embodiment shown includes an outer layer 117 of polyimide and an inner layer 118 of polyimide, with the imaging fiber 12 between the two layers. The remaining space between the outer layer 117 and the inner layer 118 of polyimide is filled with epoxy 113 over at least a portion of the length of the device. In other embodiments, the remaining space between the outer layer 117 and the inner layer 118 of polyimide is partially filled with epoxy 113. The inner layer 118 of polyimide forms the boundary of working channel 114. The combination of layers 117, 118 of polyimide and epoxy 113 forms wall 116.

[0076] In some variations, walls 116 and working channel 114 may have the same or similar characteristics as walls 16 and working channel 14 of the embodiment of FIG.

[0077] The further optical sensing fiber 30 is a fiber configured for use in Raman spectroscopy. Any suitable fiber can be used as the optical sensing fiber, for example, in an embodiment, the fibers or fiber components described in https: / / arxiv.org / abs / 2012.08836 or https: / / onlinelibrary.wiley.com / doi / full / 10.1002 / jbio.202000488 can be used as the sensing fiber, or as one of the sensing fibers. The further fiber 30 can be made, for example, using a hollow capillary in its structure, can be multi-core or single-core, and can potentially use dopants in its glass different from those used in the imaging fiber 12 to change its optical properties (e.g., fluorine for one of the fibers, germanium for the other of the fibers).

[0078] In other embodiments, the further optical sensing fiber(s) may be used for other imaging modalities, such as fluorescent imaging, or any other sensing or measurement procedure. By embedding both the optical fiber and the further optical fiber in the wall of the device, a flexible device with known alignment and / or field of view of both the optical fiber and the further optical fiber may be provided, such that both the optical fiber and the further optical fiber can be used, for example, to image and / or perform measurements on the same or overlapping or related areas of the object.

[0079] FIG. 5 is an image of the distal end of a device 200 according to another embodiment, which includes a PTFE-lined 1.2 millimeter diameter working channel 214 enclosed in 55 durometer Pebax. An outer layer 216 is made of high durometer thermoplastic Pebax heat shrunk around the fiber 12 and working channel and liner. The diameter of the optical imaging fiber in this embodiment is 300 micrometers. A mandrel is used during the fabrication of this embodiment. The mandrel holds the shape of the working channel during fabrication of the device and is then removed to create the working channel. No epoxy is used in the fabrication of this embodiment.

[0080] 6 is an image of a catheter 50 including an endoscopic probe 10 that includes an optical imaging fiber 12 and a biopsy forceps 52 emerging from the distal head of the probe 10. In this embodiment, the biopsy forceps 52 are made by Boston Scientific.

[0081] In the described embodiments, any suitable medical device, optionally any suitable therapeutic, surgical or diagnostic tool, and / or sensing device, can be passed through the working channel to access the area of ​​interest of the patient or other subject. The sensing device may, for example, in some embodiments, include one or more imaging fibers.

[0082] According to some embodiments, the fabrication process of the device uses a heat shrink lamination technique to mold a biocompatible tube around the optical imaging fiber 12, thereby embedding the optical fiber in the wall 16, and a removable mandrel and a PTFE liner to form the working channel 14. A heat gun can be used to thermally mold the heat shrink at a temperature of 230-240 degrees Celsius. In other embodiments, the temperature used will be appropriate for the material properties of the thermoplastic material. The optical fiber is inserted into a tube of material, such as a biocompatible polymer, for the process of embedding the fiber in the wall 16. A removable mandrel may be included in the tube prior to the heat shrink process. Removal of the mandrel defines an interior space, referred to as the working channel 14, with an inner surface covered with a PTFE liner. The PTFE liner forms the wall 16 of the working channel 14. The device uses commercially available biocompatible materials for the heat shrink method. Any of the embodiments of Figures 1-6, for example, can be formed using such techniques.

[0083] Other embodiments may use a catheter laminator, for example any suitable known catheter laminator, to fabricate the device.

[0084] Preferably, the mandrel has a circular cross-section and the working channel 14 created by removal of the mandrel is significantly cylindrical. In some embodiments, the completed probe 10 includes two or more optical fibers or two or more optical fiber bundles.

[0085] The optical imaging fiber 12 may be of the same construction as the optical sensing fiber 30, or in other embodiments, may be different. The optical imaging fiber 12 may consist of a single core, while the optical sensing fiber 30 may consist of multiple cores, or vice versa. The fibers may be the same or different in the material used for the cladding, such as pure silica glass and fluorine-doped silica glass. In some embodiments, an optical sensing fiber may be used instead of the optical imaging fiber.

[0086] The working channel 14 may be aligned with the central axis of the probe 10, making it concentric with the probe 10, or may be offset from the central axis, resulting in a wall 16 that varies continuously in thickness along its periphery. In other embodiments, the thickness may vary non-continuously along the periphery of the device. The thickest portion of the wall may include one-half, one-third, one-quarter, or one-eighth of the periphery where the wall has the highest average thickness. The optical fiber may be located in the thickest portion of the wall.

[0087] The fiber is encapsulated in a biocompatible polymer along its entire length. The liner may be formed of PTFE or other polymeric materials. The structure is small, strong, kink resistant, and flexible. The heat shrink process involves applying heat to a heat shrinkable biocompatible polymer until it shrinks around the optical fiber(s), the PTFE liner, and an optional removable mandrel. In some variations, a second portion of biocompatible tubing is provided over the fiber and mandrel under the heat shrink. When the heat shrink collapses, it molds this portion of the tube to encapsulate the fiber and mandrel, forming a monolithic shaft with the fiber and working channel embedded. For example, when the heat shrink is heated, it squeezes and melts the interlayer tube (i.e., the second portion of the biocompatible tubing), molding it around the fiber and encapsulating it and the liner and mandrel. This process results in the optical fiber being embedded in the wall 16 of the completed probe 10. The resulting device is flexible, and contact between the wall 16 and the optical imaging fiber 12 is maintained when the device is bent. At least one optical fiber is embedded in the wall 16 over a length including at least 50% of the length of the wall and / or at least 80% of the length of the optical imaging fiber 12. The optical fiber may be embedded in the wall 16 over a length of at least 15 cm, optionally 30 cm, or optionally at least 50 cm. The final device may be single-use disposable to avoid contamination.

[0088] Although a heat shrink process is described for providing the optical fiber in the wall of the device, any other suitable processing method can be used to provide the optical fiber(s) in the wall of the device, e.g., at least partially embedded in the wall of the device. For example, a plastic welding process, an injection molding process, an extrusion process, or any other suitable process can be used instead of a heat shrink process. In some embodiments, an extrusion process can be applied to the fiber or used to create a hole to receive the fiber. In some embodiments, the fiber can be sandwiched between an inner tube and an outer tube, with one or both of the tubes together providing the wall or a wall.

[0089] It will be understood that the invention has been described above purely by way of example and that modifications of detail can be made within the scope of the invention.

[0090] Each feature disclosed in this specification and (where appropriate) the claims and drawings may be provided independently or in any appropriate combination.

[0091] References JP2008200098A US8333691B2 EP1948056A2 US5419312 US6458076B1 WO2017 / 0158331 WO2017 / 174998 WO2017 / 149310 WO2018 / 007829 WO2017 / 203272 WO2018 / 134622 WO2018 / 203088 WO2019 / 138220 WO2019 / 243760 W02022 / 034055 https: / / arxiv.org / abs / 2012.08836 https: / / onlinelibrary.wiley.com / doi / full / 10.1002 / jbio.202000488 https: / / proteus.ac.uk / technology / fibre-bundle / https: / / link.springer.eom / article / 10.1007 / s00259-020-05021-4 https: / / www.olympus-europa.com / medical / rmt / media / en / Content / Content- MSD / Documents / Brochures / SRP-Periphery / E0428337EN_EEIII_BF- MP190_A4_EN.pdf https: / / erj.ersjournals.eom / content / 32 / 2 / 465 (“Novel thin bronchoscope with a 1.7-mm working channel for peripheral pulmonary lesions”)

Claims

1. An endoscopic device comprising a wall defining an interior space, a working channel within or defined by the interior space, and at least one optical fiber, optionally at least one optical imaging fiber embedded or otherwise provided in the wall, said endoscopic device having an outer diameter of less than 2.5 mm, optionally no greater than 2 mm.

2. The device of claim 1 , wherein the wall comprises a plastic material and / or a heat shrink material.

3. 3. The device of claim 2, wherein the plastic material and / or heat shrink material has been subjected to at least one of the plastic processing methods, optionally a heat shrink process, a plastic welding process, an injection molding process, and / or an extrusion process.

4. 4. The device of claim 1, wherein the at least one optical fiber includes optical imaging fiber(s) configured to both provide illumination to and receive light from a target area at a distal end of the fiber(s), and transmit the received light from the distal end of the fiber(s) to a proximal end of the fiber.

5. A device according to any preceding claim, wherein the or each optical fibre has an outer diameter in the range 0.1 mm to 1.0 mm, optionally in the range 0.2 mm to 0.5 mm.

6. 4. A device according to claim 1 , wherein an end face of the or each optical fibre and / or the core(s) of the fibre is substantially flat and / or free of optical components.

7. the at least one optical fiber is embedded in the wall over an embedment length that comprises at least 50% or at least 80% of the length of the wall and / or at least 50% or at least 80% of the length of the optical fiber; and / or 4. The device according to claim 1, wherein the at least one optical fiber is embedded in the wall over an embedment length of at least 15 cm, optionally at least 30 cm, optionally at least 50 cm.

8. 8. The device of claim 7, wherein both the wall and the optical fiber are flexible, and the optical fiber is embedded such that when bent, the wall and the optical fiber remain in contact over the entire embedded length.

9. 4. The device of claim 1, wherein the at least one optical fiber comprises an imaging fiber comprising a fiber bundle configured in combination to provide imaging.

10. The device of claim 1 , wherein the at least one optical fiber is configured to perform at least one of wide-field imaging, confocal imaging, and / or fluorescence imaging.

11. The device of any one of claims 1 to 3, wherein the at least one optical fiber is positioned relative to the working channel such that a medical device inserted through the working channel can access an area that is illuminated and / or imaged using the at least one optical fiber during surgery.

12. The device of claim 1 , wherein the working channel comprises a liner.

13. The device of claim 12 , wherein the liner is formed of polytetrafluoroethylene (PTFE), polyimide, FEP, or other polymeric material.

14. The device of claim 1 , wherein the working channel is configured to receive at least one medical device, optionally a therapeutic, surgical or diagnostic tool, and / or a sensing device.

15. 4. The device of any one of claims 1 to 3, wherein the working channel has an inner diameter of less than 1.8 mm, optionally no more than 1.5 mm, optionally no more than 1.2 mm, optionally no more than 1 mm.

16. 4. The device according to claim 1, further comprising at least one sensing fiber, said at least one sensing fiber also embedded or otherwise provided in said wall.

17. 17. The device of claim 16, wherein the at least one sensing fiber comprises a fiber for use in performing spectroscopy, optionally Raman spectroscopy.

18. 4. A device according to claim 1, wherein the wall has a thickness which varies, optionally continuously, around the periphery of the wall.

19. 20. The device of claim 18, wherein the at least one optical fiber is located in a thickest portion of the wall.

20. The device according to any one of claims 1 to 3, wherein the device is a disposable device, optionally a single-use disposable device.

21. 5. The device of claim 4, wherein the optical fiber is configured to be connectable at a proximal end to an endoscopic imaging device including a light source configured to input light into the at least one optical fiber at the proximal end and a light detector configured to detect light transmitted from the distal end to the proximal end of the at least one optical fiber.

22. A method of forming an endoscopic device, the method comprising inserting at least one optical fiber, optionally at least one optical imaging fiber, into a tube of material and performing a process to at least partially embed or otherwise provide the at least one optical fiber in a wall of the tube.

23. 23. The method of claim 22, wherein the process comprises at least one of a plastic processing method, a heat shrink process, a plastic welding process, an injection molding process, and / or an extrusion process.

24. 24. The method of claim 22 or 23, wherein the method further comprises providing a mandrel within the tube and removing the mandrel from the tube, thereby forming a working channel in the device.

25. 25. The method of claim 24, wherein the mandrel includes a liner, and the removing of the mandrel includes leaving the liner within the tube to form a wall of the working channel.

26. The method according to claim 22 or 23, wherein the endoscopic device comprises a device according to any one of claims 1 to 3.

27. An endoscopic system comprising: a device according to any one of claims 1 to 3; and an endoscopic apparatus, the endoscopic apparatus including a light source configured to input light into the at least one optical imaging fiber at the proximal end; and a light detector configured to detect light transmitted from the distal end to the proximal end of the at least one imaging fiber.

28. 4. A method of imaging an area of ​​a subject, comprising: inserting a device according to any one of claims 1 to 3 into the subject; transmitting light from a light source through the at least one optical fiber to the area of ​​the subject; and detecting light received from the area of ​​the subject at a proximal end of the at least one optical fiber.

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