MEDICAL ENDOSCOPY DEVICE COMPRISING A RIGID TUBE

Abstract

MEDICAL ENDOSCOPY DEVICE COMPRISING A RIGID TUBE One aspect of the invention relates to an endoscopy medical device comprising: a handle; a rigid tube comprising a proximal end fixed to the handle and a distal end opposite the proximal end, the rigid tube being made of a material having a Young's modulus greater than or equal to 100 GPa; an image acquisition device fixed to the distal end of the rigid tube; and a light source fixed to the distal end of the rigid tube. Figure to be published with the abbreviation: Figure 1

Description

Title of the invention: MEDICAL ENDOSCOPY DEVICE COMPRISING A RIGID TUBE TECHNICAL FIELD OF THE INVENTION

[0001] The technical field of the invention is that of endoscopic medical devices. The invention relates more particularly to an endoscopic medical device comprising a rigid tube and a method of endoscopy on a training mannequin using said endoscopic medical device. TECHNOLOGICAL BACKGROUND OF THE INVENTION

[0002] Endoscopic extraction of a bronchial foreign body is a surgical procedure generally performed using several instruments: • a laryngoscope which allows the larynx to be exposed by aligning the oral axis, the pharyngeal axis and the laryngeal axis; • a rigid bronchoscope inserted into the trachea, allowing visualization of the foreign body inside a bronchus; • an optical forceps comprising a sheath and jaws for grasping the foreign body; and • an endoscopy optic introduced into the sheath of the optical clamp, the optical clamp and its optic being inserted into the bronchoscope.

[0003] The endoscopic optics allow visualization of the foreign body during its extraction. It typically comprises a rigid steel tube, with a diameter and length adapted to the optical forceps and the bronchoscope (typically 2.7 to 4 mm in outside diameter and 18 to 36 cm in length), and a head attached to a proximal end of the rigid tube. An eyepiece and a connector for an external light source are mounted on the head. The optics also includes a light waveguide that extends inside the head and the tube, from the connector to the distal end of the tube. This waveguide serves to direct light from the connector of the external light source to the distal end of the tube, in order to illuminate the area to be observed within the patient's body. It also directs the endoscopic image from the distal end of the tube to the eyepiece.The waveguide typically consists of an array of optical fibers or cylindrical lenses. A camera can be positioned at the eyepiece, or in place of the eyepiece, to display the image on a screen.

[0004] Several examples of endoscopic optics are described in documents US2014 / 0235947A1, US2008 / 0097160A1 and US2018 / 0279856AL

[0005] Laryngotracheal endoscopy is very well suited to simulation-based teaching on training mannequins: the basic gestures are complex, the gestures must be precise and adapted to the size of the patient, life-threatening emergencies are frequent, teamwork is essential, adaptation and responsiveness to external constraints are not innate and require repeated practice.

[0006] Simulation-based teaching requires the use of clinical equipment to ensure optimal learning conditions. Therefore, the endoscopic optics used in teaching today are the same as those used in the operating room. This is specialized surgical equipment that is expensive and fragile. Optics currently available on the market are not designed to withstand significant mechanical stresses, particularly bending.

[0007] However, the mannequins used in simulation (generally made of plastic, silicone, or latex) do not have the same biomechanical characteristics as the human body. They are more rigid, which requires more force to be applied to the medical equipment to perform the same movements. To date, no mannequin exists whose characteristics of mouth opening, neck flexion / extension, tongue base rigidity, and laryngeal exposure closely resemble those of a living person. The mechanical stresses exerted on the medical equipment, and endoscopic optics in particular, are therefore greater in simulation than under operating room conditions.

[0008] Moreover, due to their status as learners, participants in simulation sessions may exert inappropriate mechanical constraints.

[0009] Consequently, it is not uncommon to damage or even break endoscopy optics during simulation sessions, which leads to a significant additional cost as well as unavailability of the equipment for surgical operations (while it is being repaired or changed). Summary of the invention

[0010] There is therefore a need to provide a more robust endoscopy medical device so that it can be used in simulation teaching.

[0011] According to a first aspect of the invention, this need is met by providing a medical endoscopy device comprising: • a handle; • a rigid tube comprising a proximal end fixed to the handle and a distal end opposite the proximal end, the rigid tube being formed of a material having a Young's modulus greater than or equal to 100 GPa; • an image acquisition device attached to the distal end of the rigid tube; and • a light source attached to the distal end of the rigid tube.

[0012] The image acquisition device and the light source located at the distal end of the rigid tube advantageously replace optical fibers or cylindrical lenses, which are the most fragile components of the prior art device. Thus, the risk of breakage of the endoscopic medical device is reduced and its lifespan is increased.

[0013] In a preferred embodiment, the endoscopy medical device further comprises a tip attached to the handle and into which the proximal end of the rigid tube is inserted.

[0014] According to a development of this preferred embodiment, the tip is made of metal and welded to the proximal end of the rigid tube.

[0015] In addition to the characteristics mentioned in the preceding paragraph, the endoscopic medical device according to the first aspect of the invention may have one or more additional characteristics from among the following, considered individually or in all technically possible combinations: • the endoscopy medical device lacks a light waveguide inside the rigid tube; • the rigid tube includes a wall with a thickness between 0.1 mm and 1 mm over at least 90% of its length; • the rigid tube is made of metal; • the endoscopy medical device further includes a support element fixed to the distal end of the rigid tube and on which the image acquisition device and the light source are mounted; • The rigid tube includes: • a first section having a first wall thickness and extending over at least 90% of the tube's length; and • a second part in which the support element is housed and which has a second wall thickness that is less than the first wall thickness; • The light source comprises a plurality of light-emitting diodes arranged around the image acquisition device; and • The handle includes protruding portions and depressions configured to allow for a tri-finger grip.

[0016] A second aspect of the invention relates to an endoscopy method on a training mannequin using an endoscopy medical device according to the first aspect of the invention. BRIEF DESCRIPTION OF THE FIGURES

[0017] Other features and advantages of the invention will become clear from the description given below, by way of example and not limitation, with reference to the accompanying figures, among which: • Fig. 1 represents a preferred embodiment of an endoscopy medical device according to the first aspect of the invention; • [Fig.2] schematically represents, in front view, the distal end of the endoscopy medical device, this end being equipped with an image acquisition device and a light source; • [Fig.3] represents a support element belonging to the endoscopy medical device of [Fig.1], this element serving as a support for the image acquisition device and the light source; • [Fig.4] is a top view of the upper part of a handle belonging to the endoscopy medical device of [Fig.1]; • Fig. 5A and Fig. 5B represent, respectively in side view and bottom view, the lower part of the handle.

[0018] For clarity, identical or similar elements are identified by identical reference signs throughout the figures. DETAILED DESCRIPTION

[0019] Figure 1 is an exploded view of an endoscopic medical device 1 according to a preferred embodiment of the invention. The term "medical device" means a device that relates to medicine.

[0020] The endoscopy device 1 includes in particular: • a handful 10; • a rigid tube 11; • an image acquisition device 12; and • a light source 13.

[0021] The handle 10 is the part of the endoscopy device 1 that allows a user, such as a surgeon or a surgical student, to hold it. It can be formed of two parts: a first part 10a (lower part in the orientation of [Fig. 1]) and a second part 10b (upper part) which are assembled together, for example by means of screws 14.

[0022] The rigid tube 11 comprises two opposing ends: a proximal end 1a (located closest to the handle, and therefore to the user's hand) and a distal end 11b (located furthest from the handle). The proximal end 1a of the rigid tube 11 is attached to the handle 10. The distal end 11b of the tube is intended to be inserted into the body of a patient or a training mannequin.

[0023] By rigid tube, we mean a tube made of a material having a Young's modulus greater than or equal to 100 GPa, preferably greater than or equal to 150 GPa, as opposed to the flexible tubes used in fiberscopes, which are made of flexible materials. The rigid tube 11 is preferably made of a metal (pure metal or alloy), for example stainless steel (approximately 200 GPa).

[0024] Thanks to its rigid tube 11, the endoscopy device 1 is easier to use, more robust and more durable than a fiberscope. It can be inserted more easily into the airways and does not require a complex head orientation device.

[0025] The image acquisition device 12 is attached to the distal end 11b of the rigid tube 11. It is arranged so as to be able to provide images of a so-called observation area that is to be visualized by means of the endoscopy device (the observation area is in practice located inside the body of the patient or mannequin). The image acquisition device 12 can be an image sensor or a camera (i.e., a system comprising, in addition to an image sensor, a lens and a housing).

[0026] The light source 13 is also fixed to the distal end 11b of the rigid tube 11. It is arranged so as to illuminate the observation area. The light source 13 is preferably a cold light source, that is, a light source whose operating temperature does not exceed 37 °C. In particular, it may include one or more light-emitting diodes (LEDs), preferably white (color temperature, for example, between 5000 K and 7000 K).

[0027] With reference to [Fig. 2], the light source 13 may comprise several LEDs 131, for example four in number, arranged around the image acquisition device 12, in order to obtain homogeneous illumination of the observation area. The LEDs 131 may be arranged in pairs symmetrically with respect to the image acquisition device 12.

[0028] In the endoscopy device 1, the acquisition of the endoscopic image and the illumination is carried out directly at the distal end of the rigid tube 11. Thus, the endoscopy device 1 may be devoid of a light waveguide, such as an assembly of optical fibers or lenses, inside the rigid tube 11 to guide the light to the distal end 11b of the rigid tube 11 or to convey, in the opposite direction, the endoscopic image to a sensor.

[0029] The elimination of the light waveguide, made possible by positioning the image acquisition device 12 and the light source 13 at the distal end 11b of the rigid tube 11, reduces the risk of breakage. The endoscopy device 1 is therefore less fragile and more reliable than prior art devices equipped with a light waveguide.

[0030] Removing the light waveguide inside the rigid tube 11 also allows for an increase in the wall thickness of the rigid tube 11 (i.e., the difference between its outer diameter and inner diameter divided by two) while maintaining a constant outer diameter (since there is more space available), at least over a large portion of its length. The robustness of the endoscopy device 1 is thus further increased compared to prior art devices. The wall thickness of the rigid tube 11 is advantageously between 0.1 mm and 1 mm (more preferably between 0.4 mm and 1 mm) over at least 90% of its length, and preferably over its entire length. The length of the rigid tube 11 can be between 18 cm and 36 cm.

[0031] The endoscopy device 1 of [Fig. 1] may further include a support element 15 fixed to the distal end 11b of the rigid tube 11 and on which the image acquisition device 12 and the light source 13 are mounted. Thus, the image acquisition device 12 and the light source 13 are fixed to the distal end 11b of the rigid tube 11 by means of the support element 15. The support element 15 simplifies the mounting of the image acquisition device 12 and the light source 13 on the rigid tube 11.

[0032] The support element 15 is advantageously dimensioned to be inserted into the rigid tube 11, via the distal end 11b. It occupies a small part of the internal space of the rigid tube 11.

[0033] With reference to [Fig.3], the support element 15 may include a housing 151 dimensioned to receive the image acquisition device 12. The housing 151 is open on an outer face 152 of the support element 15, this outer face 152 being oriented towards the observation area when the support element 15 is inserted into the rigid tube 11. The light source 13 is preferably fixed on the outer face 152 of the support element 15.

[0034] The support element 15 is preferably mounted tightly and glued inside the rigid tube 11. It is for example made of a polymer material.

[0035] The rigid tube 11 may have a constant or substantially constant outer diameter (± 3% variation) along its entire length. This outer diameter is, for example, between 2.7 mm and 4 mm, preferably between 2.8 mm and 2.9 mm. Conversely, its inner diameter may be variable in order to more easily accommodate the support element 15 inside the distal end 11b.

[0036] Thus, the rigid tube 11 may have a first wall thickness in a first portion extending over at least 90% of its length and a second wall thickness, less than the first wall thickness, in a second portion where the support element 15 is housed. Preferably, the first wall thickness is between 0.1 mm and 1 mm (preferably between 0.4 mm and 1 mm) and the second The wall thickness is between 0.05 mm and 0.1 mm. As an example, the first wall thickness is equal to 0.45 mm and the second wall thickness is equal to 0.1 mm.

[0037] Alternatively, the internal diameter of the rigid tube is constant or substantially constant (± 3% variation) over the entire length of the tube and the wall thickness of the rigid tube 11 is advantageously between 0.1 mm and 1 mm (preferably between 0.4 mm and 1 mm).

[0038] In the preferred embodiment of [Fig.1], the endoscopy device 1 further includes a tip 16 fixed to the handle 10 and into which the proximal end 1la of the rigid tube 11 is inserted. This tip 16 increases the resistance of the endoscopy device 1 to mechanical stresses, and in particular to the leverage effect.

[0039] The end piece 16 can be made of metal and welded to the proximal end 1 of the rigid tube 11. The metal of the end piece 16 is preferably the same as that forming the rigid tube 11.

[0040] At least part of the tip 16 is held inside the handle 10, preferably between its two parts 10a-10b. The tip 16 is, for example, positioned between two screws 14 which secure the two parts 10a-10b of the handle 10 together.

[0041] As shown in [Fig.1], the endoscopy device 1 can also include a first electronic board 17 for controlling the image acquisition device 12 and a second electronic board 18 for controlling the light source 13. These electronic boards 17-18 are, for example, arranged inside the handle 10.

[0042] The image acquisition device 12 and the light source 13 can each be connected to their electronic board by one or more wires, which extend inside the rigid tube 11.

[0043] An electrical connector 19 can be fixed on the first electronic card 17, in order to connect the endoscopy device 1 to a screen (for displaying images) or to a computer (for displaying and recording images for example).

[0044] Since it is not necessary to attach a remote camera to the endoscopy device 1 (since it has its own image acquisition device), the handle 10 can be ergonomically designed.

[0045] As shown in Figures 4 and 5A-5B, the handle 10 may include protruding portions 101 and depressions 102 to facilitate gripping the endoscopy device 1. These protruding portions 101 and depressions 102 are preferably configured to allow a tri-digital grip, i.e., with the thumb, index and middle finger (the other fingers being folded).

[0046] The protruding portions 101 and depressions 102 are advantageously symmetrical with respect to a median plane of the handle 10, so that the endoscopy device 1 can be used by both a left-handed and a right-handed user.

[0047] Thanks to its robustness, the endoscopy device 1 is suitable for use in simulation-based teaching on a training mannequin, where the mechanical stresses exerted on the medical equipment are particularly high. It can notably be used to learn pediatric emergency procedures such as the removal of foreign bodies from the airways. The endoscopy device 1 also allows for the performance of endoscopies, such as airway endoscopies.

[0048] The endoscopy device 1 performs the same functions as prior art endoscopy optics and can be used in the same way. The endoscopy device 1 can therefore be described as an endoscopy optic. It can be used alone (for observation only) or in combination with an optical forceps (typically for the extraction of a foreign body). The uniformity of the external diameter of the rigid tube 11 facilitates its insertion into the optical forceps (insertion that would not be possible with a flexible tube).

[0049] The endoscopy device 1 is designed to withstand mechanical stresses and frequent handling, thus offering greater longevity. It is advantageously configured to withstand a bending force of at least 60 Nm without damage.

[0050] The endoscopy device according to the invention is not limited to the preferred embodiment described in relation to [Fig. 1]. In particular, it may comprise a single electronic board for controlling the lighting and acquiring images. The control electronics may also be located outside the endoscopy device, for example, so that they can be shared between several endoscopy devices.

[0051] Moreover, although this assembly is more difficult, the image acquisition device 12 and the light source 13 can be fixed directly onto the rigid tube 11, in other words without the support element 15.

Claims

Demands

1. Endoscopy medical device (1) comprising: - a handle (10); - a rigid tube (11) comprising a proximal end (1a) fixed to the handle (10) and a distal end (11b) opposite the proximal end (10a), the rigid tube being formed of a material having a Young's modulus greater than or equal to 100 GPa; - an image acquisition device (12) fixed to the distal end (11b) of the rigid tube (11); and - a light source (13) fixed to the distal end (11b) of the rigid tube (11).

2. Device (1) according to claim 1, devoid of a light waveguide inside the rigid tube (11).

3. Device (1) according to any one of claims 1 and 2, wherein the rigid tube (11) comprises a wall of thickness between 0.1 mm and 1 mm over at least 90% of its length.

4. Device (1) according to any one of claims 1 to 3, wherein the rigid tube (11) is made of metal.

5. Device (1) according to any one of claims 1 to 4, further comprising a nozzle (16) integral with the handle (10) and into which is inserted the proximal end (lia) of the rigid tube (H).

6. Device (1) according to claim 5, wherein the tip (16) is made of metal and welded to the proximal end (lia) of the rigid tube (11).

7. Device (1) according to any one of claims 1 to 6, further comprising a support element (15) fixed to the distal end (11b) of the rigid tube (11) and on which are mounted the image acquisition device (12) and the light source (13).

8. Device (1) according to claim 7, wherein the rigid tube (10) comprises: • a first portion having a first wall thickness and extending over at least 90% of the length of the tube; and • a second part in which the support element (15) is housed and which has a second wall thickness less than the first wall thickness.

9. Device (1) according to any one of claims 1 to 8, wherein the light source (13) comprises a plurality of light-emitting diodes (131) arranged around the image acquisition device (12).

10. Device (1) according to any one of claims 1 to 9, wherein the handle (10) comprises projecting portions (101) and depressions (102) configured to permit a tri-finger grip.

11. Method of endoscopy on a training mannequin using a medical endoscopy device (1) according to any one of claims 1 to 10.

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