Endoscope guide, in particular for colonoscope, and endoscopy system comprising said guide

Abstract

The invention relates to an endoscope guide, in particular an endoscope guide suitable for colonoscopy applications. In particular, the invention relates to an endoscopy system, in particular for colonoscopy, comprising: an endoscope guide, in particular for colonoscopy, comprising a tubular guide element (1) and an anchoring head (2), the tubular guide element (1) comprising a longitudinal cavity (3) in which the tubular guide element (1) is arranged, and the anchoring head (2) is arranged in the longitudinal cavity (3). The anchoring head (2) is provided with an expandable container (4) configured to contain a ferromagnetic agent, the expandable container (4) being in communication with the longitudinal cavity (3), and wherein the endoscopy system further comprises a ferromagnetic agent configured to be movable in the longitudinal cavity to fill / empty the expandable container (4), characterized in that the expandable container (4) is provided with an anchoring portion (5), the ferromagnetic agent is an aqueous suspension of carbonyl iron.

Description

Technical Field

[0001] The present invention relates to an endoscope guide for a catheter or an endoscope, and in particular to an endoscope guide suitable for colonoscopy applications.

[0002] Examples of such instruments are colonoscopes, enteroscopes, gastroscopes, duodenoscopes, echoendoscopes and the like. Background Art

[0003] Endoscopic guides (or "guide wires" in technical terms) are used in the art for positioning and acting as guides, particularly for catheters, which are usually slidably mounted thereon; in this regard, the catheter is provided with an operating channel in which the guide itself is placed in the assembled state.

[0004] Various types of endoscope guides are known in the art, depending on their intended application.

[0005] One type of endoscopic guide provides an anchoring head that allows the guide to remain in place and acts as a support for catheter and endoscopic manipulation.

[0006] In this regard, in certain embodiments, the guide is provided with an inflatable balloon which, once introduced into the lumen of the organ and positioned, is inflated with air until it interferes with the walls of the lumen itself, thereby remaining locked in place.

[0007] Although these guides with expandable anchoring heads are used, they have considerable disadvantages.

[0008] Another limitation of some of these solutions is related to the fact that the inner cavity in which the introducer head is placed is blocked: in particular, completely blocked in the case of an inflatable balloon.

[0009] Moreover, such an anchoring head is difficult to use in certain areas of endoscopy, such as in the case of colonoscopy, for example, due to the anatomical shape of the organ in which the guide is introduced. In fact, the diameter of the lumen in the colon can vary from 2-3 cm up to 6-8 cm, depending on the segment considered and whether there are pathological conditions or anatomical abnormalities. This necessitates a balloon of even considerable bulk.

[0010] Furthermore, anchoring via the balloon is obtained by means of the friction forces generated between the balloon and the surface of the organ mucosa. This can lead to damage to the organ wall. In the case of colonoscopy, frictional obstruction makes it necessary to increase the pressure on the visceral wall, stretching the balloon even more, in order to obtain a more stable anchoring. However, this procedure can lead to excessive stretching of the viscera, with the risk of causing pain or even tissue tearing. In addition, sometimes, especially in the elderly or in certain pathological conditions, the viscera can expand or relax to the point where there is no resistance to balloon expansion. In this case, the stretching of the balloon is not only risky, but also ineffective.

[0011] However, obtaining a firm and stable anchoring is necessary in order to ensure that the guide can also be used for colonoscopy and endoscopy in general.

[0012] In particular, the colonoscopy technique requires the careful introduction of the colonoscope to the end point of the colon, called the cecum, which, due to its tortuous path and loose walls, forms a loop that prevents the advancement of the colonoscope tip and stretches the walls of the colon, resulting in the occurrence of pain and the risk of tearing the internal organs. In these cases, the doctor must manipulate the instrument in an appropriate way in order to correct the path as much as possible and to operate by introducing the colonoscope to the cecum or in any case exploring the entire internal organs.

[0013] It should also be noted that the main difference between a colonoscope and a standard catheter is that the colonoscope is much more massive. As the mass of the catheter or endoscope increases, there is a need for a guide with increased rigidity. However, guides currently used in endoscopy cannot be made of particularly rigid materials because a rigid tip could damage internal organs.

[0014] As described in the applicant's European patent EP3399901A1, many of the problems associated with prior art devices have been overcome by an endoscope guide and an endoscopy system comprising the guide. The patent describes a system for magnetically anchoring the end of an endoscope guide by introducing a magnetic fluid consisting of iron powder, magnetite, hematite or an aqueous suspension of a ferromagnetic fluid into an inflatable balloon. Anchoring is achieved by applying a magnetic field of sufficient force from the outside.

[0015] Although this system allows obtaining sufficient anchoring to the wall of the colon without obstructing the lumen of the organ and without damaging its tissues, it has various drawbacks.

[0016] A first problem is that, during the introduction step along the tortuous path of the colon, the guide catheter may experience a so-called kinking phenomenon.

[0017] It has also been found that by using the volumes of magnetic fluid provided in the aforementioned patents and the concentration of magnetizable particles contained therein, excessive fluid viscosity can be obtained: this leads to excessively long times for filling and emptying the balloon and to the operator having to apply excessive force for filling.

[0018] Furthermore, the frequent formation of clusters and / or agglomerates of ferromagnetic particles in the balloon after application of a magnetic field further slows down or even prevents emptying at the end of the procedure.

[0019] In some cases, during storage, clusters and / or clumps of identical ferromagnetic particles have formed in the pre-filled syringe, thus preventing filling of the balloon and rendering the system set up for the balloon unusable.

[0020] It is therefore an object of the present invention to provide an endoscope guide for a catheter or an endoscope which solves one or more of the technical problems mentioned above with respect to known magnetic anchoring systems.

[0021] In particular, the object of the invention is to produce an endoscope guide that can be operated more quickly with less effort or with less risk of clogging than known endoscope guides with magnetic anchoring, while being relatively cheap and simple to produce, thereby being a disposable system. Summary of the invention

[0022] One or more of the tasks and objectives listed above, as well as other tasks and objectives clearly shown below, are achieved by:

[0023] 1) An endoscopic inspection system, comprising an endoscopic guide, in particular an endoscopic guide for a colonoscope, the guide comprising a tubular guide element and an anchoring head, wherein the tubular guide element comprises a longitudinal cavity, the anchoring head is provided with at least one expandable container configured to contain a ferromagnetic agent, the expandable container is connected to the longitudinal cavity, wherein the endoscopic inspection system further comprises a ferromagnetic agent configured to be movable in the longitudinal cavity to fill / empty the container, characterized in that the ferromagnetic agent is an aqueous suspension of hydroxy iron.

[0024] Other objects of the present invention are:

[0025] 2) The endoscopy system according to point 1) further comprises a magnetic field source configured to apply a holding force greater than or equal to 5 Newtons to the ferromagnetic agent at a distance between 2 cm and 10 cm from the ferromagnetic agent relative to the lateral pulling direction;

[0026] 3) The system according to point 1) or point 2), further comprising a syringe pre-filled with the ferromagnetic reagent;

[0027] 4) A system according to any one of points 1) to 3), wherein the purity of the hydroxy iron is greater than or equal to 97.5%, or greater than or equal to 99.5%, and is composed of spherical particles having the following particle size distribution:

[0028] D10 = 3-4.5 microns, or about 4.1 microns,

[0029] D50 = 5-10 microns, or about 9.5 microns,

[0030] D90 = 4-30 microns, or about 26 microns;

[0031] 5) The system according to any one of points 1) to 4), wherein the aqueous suspension of hydroxyiron contains between 45% and 60%, or between 50% and 55%, or between 52% and 53% by weight of carbonyl iron relative to the total weight of the suspension;

[0032] 6) The system according to any one of points 1) to 5), wherein the aqueous suspension of ferric hydroxylate contains between 2.5% and 4.5% by weight of trivalent sodium citrate relative to the total weight of the suspension, and / or contains between 5% and 8% by weight of sodium chloride relative to the total weight of the suspension;

[0033] 7) The system according to any one of points 1) to 6), wherein the tubular guide element has a single lumen and has an outer diameter of less than 2.6 mm, or about 2.5 mm, and the inner diameter of the lumen of the tubular guide element is between 1.6 mm and 1.75 mm, or about 1.7 mm;

[0034] 8) The system according to any one of points 1) to 7), wherein the expandable container comprises or consists of an inflatable balloon, and the size of the container is designed to have a capacity of 22-28 ml or about 25 ml, and when in the expanded state, the length of the container is between 55 mm and 65 mm, or about 60 mm, and the transverse diameter is between 20 mm and 30 mm, or about 25 mm;

[0035] 9) The system according to any one of points 1) to 8), wherein the syringe comprises a cylinder into which the piston is slidably inserted, and a removable gripping flange;

[0036] 10) A system according to point 9), wherein the cylinder comprises an open end into which the piston can be inserted and a coupling end opposite to the open end, the coupling end being provided with a connector for a tubular guide element, wherein the open end comprises an outwardly protruding annular shoulder, and wherein the connector is a male "Luer lock" type and comprises a cylindrical sleeve with an internal thread and a nozzle coaxially arranged inside the cylindrical sleeve.

[0037] 11) The system according to point 9) or point 10), wherein the piston comprises a body extending along the longitudinal axis between the proximal portion and the distal portion and preferably consisting of a structure having wings arranged in a cross shape;

[0038] 12) A system according to point 11), wherein the distal portion of the piston includes a tip, a sealing flange and a stop flange, and is configured so that when the syringe is pre-filled with a ferromagnetic reagent and assembled, the stop flange is flush with the annular shoulder of the cylinder, thereby determining the pushing position of the piston.

[0039] 13) The system according to any one of points 10) to 12), wherein the gripping flange comprises a recess and a groove, the recess being sized to be coupled to the open end of the cylinder, and the groove surrounding the recess and having a portion protruding toward the interior of the recess, the groove being configured to be inserted into the annular shoulder;

[0040] 14) An endoscopy kit comprising an endoscope guide according to any one of points 1) to 8), a syringe according to any one of points 9) to 13), and optionally a catheter;

[0041] 15) The kit according to point 14), wherein the syringe is filled with the suspension of carbonyl iron;

[0042] 16) The kit according to point 14), comprising a glass bottle filled with a powdered ferromagnetic agent and a syringe pre-filled with a saline solution, or a glass bottle with a suspension of a ferromagnetic agent and an empty syringe.

[0043] These two versions of the kit allow for longer storage of powder.

[0044] The invention also relates to an endoscopy system, in particular an endoscopy system for colonoscopy, comprising an endoscope guide according to the invention acting in combination with an external magnetic field source, as defined in the appended claims, wherein the magnetic field source is preferably associated with a manual manipulation device, i.e. also without a moving device or auxiliary support. In certain embodiments, the manual manipulation device is a handpiece, wherein the magnetic field source is movable between an operating position and a safe or rest position, wherein:

[0045] In the operating position, the magnetic field source is close to the operating end of the handpiece.

[0046] In the safe or resting position, the source of the magnetic field is directed away from the operative end of the handpiece.

[0047] Further characteristics and advantages will become clear from the description of preferred but non-exclusive embodiments of the invention, which are illustrated by way of non-limiting examples. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Figure 1A is a cross-sectional view of a first embodiment of a syringe for ferrofluid according to the present invention;

[0049] Figure 1B is based on Figure 1A A side view of the syringe in direction A;

[0050] Figure 2 yes Figure 1A A cross-sectional view of a detail of a syringe in FIG.

[0051] Figure 3 yes Figure 1A Cross-sectional views of different details of the syringe in;

[0052] Figure 4A and Figure 4B They are Figure 1A Another perspective and plan view of a different detail of the syringe in FIG.

[0053] Figure 5 yes Figure 1A A longitudinal cross-sectional view of a piston of a syringe in FIG.

[0054] Figure 6 is a cross-sectional view of a tubular guiding element of a system according to the present invention;

[0055] Figure 7 is a side view of an expandable container of a system according to the present invention in an expanded state. DETAILED DESCRIPTION

[0056] First, a description of how a diagnostic colonoscopy is performed will help to better understand the present invention.

[0057] A colonoscope is a flexible endoscope characterized by a tip (approximately 15 cm long), a body (approximately 130 cm long) and a manipulator. The tip is removable and houses a camera, a light and an orifice for an operating channel. The tip can be manipulated by moving a knob located on the manipulator. The body is flexible and, in some models, this flexibility can also be selected to perform certain endoscopic operations. Cables for transmitting images, a power source and a tie rod for connecting the tip to the knob slide inside the body.

[0058] In addition to a knob for positioning the tip, the manipulator features an external orifice for operating the channel and features controls for aspirating or blowing air and recording images or video.

[0059] Diagnostic colonoscopy aims to examine the entire surface of the colonic mucosa in order to identify any pathological changes that may require further diagnostic or therapeutic intervention. The end of the colonoscope, which is equipped with a camera and light, must reach the last part of the colon, called the cecum. If the instrument does not reach the cecum, the doctor cannot determine whether the unexplored segment has any pathological changes.

[0060] Positioning of the colonoscope is performed by moving the endoscope guide forward into the lumen of the colonoscope until it extends out from its distal end and is advanced as deep as possible, then guiding the path of the colonoscope. Similar techniques are performed to introduce other endoscopes, as well as to introduce catheters into the venous system.

[0061] The colon is a mobile hollow tubular organ with a porous wall. Unlike other hollow tubular organs (such as arteries), the colon has a larger diameter, the wall can stretch more than a few centimeters, and sometimes up to 30 cm in some segments, and the internal organs can move within the abdominal cavity.

[0062] This anatomical feature prevents the insertion of catheters or guides over segments exceeding 10-30 cm. In fact, once inserted into the rectum via the anus, the catheter tends to coil on itself due to the larger diameter of the lumen and the curvature of the viscera. Therefore, unlike what is done in the vascular field, catheterization of the colon is difficult to perform except on a small segment. Even during radiological examinations, the catheter or endoscope guide does not have sufficient terminal mobility or sufficient load-bearing strength. The load-bearing strength of an endoscope, catheter or endoscope guide refers to the ability to transfer thrust from the body of the instrument to its end. The greater the stiffness of the endoscope, the greater the load-bearing strength. However, an endoscope that is too rigid cannot be easily manipulated along the curved path of the colon. The colonoscope is designed so that a compromise is made between sufficient flexibility and sufficient load-bearing strength.

[0063] However, if the colonoscope is placed in an overly curved arrangement, the load-bearing strength is gradually reduced. For example, if the colonoscope forms a loop during a colonoscopy, it can no longer transmit the thrust from the body to the tip, and the endoscopist is unable to further advance the instrument and its camera. In these cases, the endoscopist manually pushing the instrument will only transfer force to the wall of the internal organs, causing pain and risk of trauma, without advancing the tip.

[0064] In order to solve this drawback, the endoscopic guide proposed in the above-mentioned patent EP3399901A1 of the applicant allows to carry out a method for introducing a colonoscope, which method comprises the following steps:

[0065] - introducing the distal end of the colonoscope through the patient's anus until the obstruction point is reached, ie the point beyond which the colonoscope cannot be advanced any further;

[0066] - Advancing the endoscope guide to a distance of 4-10 cm beyond the distal end of the colonoscope;

[0067] - introducing a magnetic or ferromagnetic agent into an expandable container of an endoscope guide so that the container reaches an expanded state;

[0068] - applying an external magnetic field by means of a magnetic field source at the abdominal area in which a dilation container with a magnetic or ferromagnetic agent is present, so as to attract the container against anchoring points on the wall of the colon with a holding force on the magnetic or ferromagnetic agent of at least equal to or greater than 5 Newtons relative to the transverse pulling direction;

[0069] - tensioning the endoscope guide by applying a pulling force of at least 5 Newtons at the proximal end of the endoscope guide;

[0070] -Advance the colonoscope to the anchor point of the container;

[0071] - Repeat the above steps until you reach the anchoring point at the cecum.

[0072] Pulling on the endoscope guide is intended to keep the guide taut, allowing the endoscope to slide more easily, and is intended to at least partially reduce the curvature of the loops of the colon, even in this case in order to facilitate the introduction of a relatively rigid endoscope.

[0073] As mentioned above, the endoscopy system described in EP3399901A1, when performing the above method, highlights certain criticalities that make its use unsuitable for diagnosis. The present invention therefore arises from the need to overcome these criticalities.

[0074] The system according to the present invention will now be described with reference even to the accompanying drawings.

[0075] The endoscopic inspection system according to the present invention includes an endoscopic guide, in particular an endoscopic guide for a colonoscope, which includes a tubular guide element 1 and an anchoring head 2, wherein the tubular guide element 1 includes a longitudinal cavity 3, and the anchoring head 2 is provided with an expandable container 4 configured to accommodate a ferromagnetic agent, and the expandable container 4 is connected to the longitudinal cavity 3, wherein the endoscopic inspection system further includes a ferromagnetic agent configured to be movable in the longitudinal cavity to fill / empty the expandable container 4.

[0076] In a preferred embodiment, the system further comprises a syringe 5 prefilled with said ferromagnetic reagent, or a syringe prefilled with a saline solution, and a vial with the ferromagnetic reagent as a powder for reconstitution of the mixture prior to the endoscopic procedure, or a vial with a suspension of the ferromagnetic reagent and an empty syringe, which is filled prior to the endoscopic procedure by drawing the mixture from a glass vial.

[0077] The tubular guiding element 1 comprises a proximal end 1 a , which is close to the operator, and a distal end 1 b .

[0078] The anchoring head 2 may be placed at or adjacent to the distal end 1 b of the tubular guiding element 1 , while the connecting device 6 (preferably removably coupled to the tubular guiding element 1 ) is placed at the proximal end 1 a. The connecting device 6 is configured to be removably coupled to said prefilled syringe 5 .

[0079] According to the invention, the tubular guiding element 1 has at least one longitudinal cavity 3 and the anchoring head 2 is provided with an expandable container 4 for containing said ferromagnetic agent.

[0080] The tubular guiding element 1 preferably has a single lumen (i.e., it houses only one longitudinal cavity 3 therein), but in some variations it has additional cavities (e.g., two cavities in the case of a double lumen) for the passage of air, fluids or endoscopic accessories; in this case, it may include a sheath defining each additional lumen, which may terminate beyond the anchoring head 2.

[0081] It is important for an endoscope guide to have a lumen that is wide enough to allow the ferromagnetic agent to flow quickly and easily while reducing kinking. In this regard, the tubular guide element 1 of the endoscope guide of the present invention preferably has an outer diameter D of less than 2.6 mm, and the inner diameter d of the lumen of the tubular guide element 1 is between 1.6 mm and 1.75 mm.

[0082] In a particularly preferred embodiment, the tubular guiding element 1 has an outer diameter of approximately 2.5 mm, an inner diameter of approximately 1.7 mm, and the thickness of the wall S is therefore approximately 0.4 mm. Such dimensions are particularly advantageous in terms of reducing kinking and even for inserting it into a flexible optical endoscope with a diameter of 3.2 mm. The term "approximately" means that the dimensions vary more or less within the usual measurement errors or production variability.

[0083] Alternatively, the overall length of the tubular guiding element 1 preferably allows replacement of the catheter with another catheter, for example a catheter of a different type, during the procedure. Typically, the length of the tubular guiding element 1 is between 2.5 and 4 meters.

[0084] An expandable container 4 is placed in communication with the longitudinal cavity 3 of the tubular introducing element 1 .

[0085] In a preferred embodiment, the mutual arrangement of the container 4 and the tubular guiding element 1 is as shown, ie the expandable container 4 is placed close to the distal end of the tubular guiding element 1, which passes through the expandable container 4 and protrudes from the end portion 1c.

[0086] The length of the end portion 1 c varies from a few millimeters to a few centimeters; in the second case, it is preferably soft and elastic so as not to damage the mucosa when the guide is pushed towards the wall of the internal organ.

[0087] In this embodiment, the expandable container 4 therefore extends peripherally around the tubular guiding element 1 so as to completely surround the tubular guiding element at least over a given axial length.

[0088] In other embodiments (not shown), the expandable container 4 is instead placed so as to cover the distal end 1 b of the tubular guiding element 1 opening into the expandable container 4 .

[0089] The expandable container 4 is preferably manually expandable and contractible in an elastic manner to switch from a contracted state, in which the container is substantially adhered to the body of the tubular guide element 1, to an expanded state, in which the container protrudes outward from the body of the tubular guide element 1, and vice versa; the expandable container 4 is filled or emptied with the aid of a ferromagnetic agent so that the expandable container can be switched from a retracted position to an expanded position, and vice versa.

[0090] The expandable container 4 comprises an inflatable balloon, or optionally consists of an inflatable balloon. The inflatable balloon may be elastic, semi-elastic or inelastic. Examples of inflatable balloons are those commonly used in endoscopy, such as nylon balloons or balloons made of polyether-polyamide block copolymers or their compounds with polyamides. Such copolymers and their compounds with polyamides are known and described in detail in patent publication WO 2007 / 132485 A1.

[0091] In a preferred embodiment, the expandable container 4 is sized to have a capacity of 22-28 ml, more preferably about 25 ml, and when in the expanded state, a length between 55 mm and 65 mm, more preferably about 60 mm, and a transverse diameter between 20 mm and 30 mm, more preferably about 25 mm. Such dimensions do not obstruct the lumen of the colon, which, depending on the cross section observed, has a diameter varying between 3 cm and 7 cm.

[0092] Optionally, the tubular guiding element 1 comprises a valve, which is arranged upstream of the expandable container 4, ie closer to the operator, and is suitable for preventing the backflow of the ferromagnetic agent when the expandable container 4 is filled with the ferromagnetic agent.

[0093] After lengthy and precise experiments, the Applicant has found that the ferromagnetic agent most suitable for the purposes of the present invention is an aqueous suspension of the so-called hydroxyferric acid.

[0094] Carbonyl iron is a high purity iron (97.5% for S grade and at least 99.5% for R grade) obtained by chemical decomposition of purified pentacarbonyl iron. It usually has the appearance of a grey powder consisting of spherical particles. Most impurities are carbon, oxygen and nitrogen. The most common uses are in powder metallurgy, metal injection molding and various specialty products. Carbonyl iron powder is used in pharmaceutical applications to treat iron deficiency and as an iron food supplement due to its low toxicity.

[0095] For the purposes of the present invention, carbonyl iron having the following particle size distribution is preferably used:

[0096] D10 = 3-4.5 microns, more preferably about 4.1 microns,

[0097] D50 = 5-10 microns, more preferably about 9.5 microns,

[0098] D90 = 4-30 microns, more preferably about 26 microns.

[0099] The particle size of the ferromagnetic particles can be determined by known methods, such as:

[0100] - Direct observation by electron microscopy;

[0101] - Determination of aqueous suspensions by the "laser light scattering" method using a particle size laser analyzer (Malvern Mastersizer 3000) and the LALLS (Low Angle Laser Light Scattering) technique using Fraunhofer calculation theory.

[0102] The aqueous suspension of hydroxyferric according to the invention is preferably a suspension in purified water in which there is between 45% and 60% by weight, preferably between 50% and 55%, more preferably between 52% and 53% carbonyl iron relative to the total weight of the suspension. Preferably, the aqueous suspension further comprises between 2.5% and 4.5% by weight of trivalent sodium citrate relative to the total weight of the suspension, and / or comprises between 5% and 8% by weight of sodium chloride relative to the total weight of the suspension.

[0103] Sodium citrate promotes the dispersion of carbonyl iron particles in the suspension.

[0104] Sodium chloride inhibits bacterial growth.

[0105] The aqueous suspension of hydroxyferric is preferably degassed, for example by blowing in an inert gas such as nitrogen or argon, in order to avoid a process in which the iron is oxidized by oxygen absorbed in the water.

[0106] The syringes are preferably vacuum packed with an atmosphere modified with an inert gas such as nitrogen or argon. The bags used have an aluminum coating to limit the passage of oxygen.

[0107] It has been noted that the use of an aqueous suspension of carbonyl iron according to the invention has several advantages compared to known solutions, namely:

[0108] i) the aqueous suspension of carbonyl iron has an enhanced magnetic response, thereby reducing the amount of aqueous dispersion used and thus reducing the filling volume of the expandable container 4;

[0109] ii) the spherical shape of the particles results in a lower viscosity of the aqueous suspension and a reduced risk of formation of clusters and / or agglomerates;

[0110] iii) Carbonyl iron is widely available in the market with moderate cost and low toxicity, which is compatible with pharmaceutical use.

[0111] Thus, by using the aqueous suspension of hydroxyferric according to the invention, many of the problems arising from known endoscopy systems are solved and in particular an increase in the speed for filling and emptying the expandable container 4 is achieved (due to the lower viscosity of the suspension and the smaller amount of suspension required, equal attraction forces), a reduction in operator effort (lower viscosity of the suspension and smaller volumes pumped with the syringe), a reduced risk of kinking of the tubular guiding element 1 (lower viscosity and the smaller amount of aqueous suspension of ferromagnetic agent required allow for a smaller internal diameter).

[0112] The endoscopic inspection system of the present invention includes an endoscope guide as described above and further includes an external magnetic field source configured to apply a retaining force greater than 5 Newtons to the ferromagnetic agent at a distance between 2 cm and 10 cm relative to the lateral pulling direction.

[0113] The term "exerting a retaining force on the ferromagnetic agent relative to a lateral pulling direction" refers to a retaining force exerted on the ferromagnetic agent relative to a pull that is substantially perpendicular to the direction of maximum attraction between the magnet and the ferromagnet, as determined by the magnetic field lines of the magnetic field.

[0114] The holding force of the expandable container 4 against the wall of the colon relative to the lateral pulling direction (which, as mentioned above, is equal to or greater than 5 Newtons to allow sufficient pulling of the endoscope guide) depends on the amount of ferromagnetic agent in the container 4 and the applied magnetic field, which in turn depends on the distance of the magnetic field source from the container 4 filled with the ferromagnetic agent. Typically, in most colon segments, such distance is between 2 cm and 5 cm. However, such distance is greater in obese patients, for example up to 10 cm.

[0115] The external magnetic field source is selected according to the type of use of the device and the type of patient. A permanent magnet or an electromagnet can be used, preferably the first. For the purpose of the present invention, a magnetic field comparable to the magnetic field generated by a permanent magnet with disk magnetization N45 (i.e. a magnet with a maximum magnetic energy per volume that can be stored in the magnet of 45 Mega-Gauss-Oersted) can be used, the permanent magnet having a diameter of 50 mm to 80 mm and a thickness of 30 mm to 60 mm. If a permanent magnet is used, it can be made of sintered neodymium, sintered ferrite, molded neodymium (plasto-neodymium), etc.

[0116] The magnetic field source may preferably be contained in a handpiece specially adapted for this application, such as described in EP 3 399 901 A1.

[0117] In a preferred embodiment, the step of applying a magnetic field can be performed by applying such a magnetic field in a gradual manner. If the required magnetic field is applied very quickly indeed, it will cause a sudden movement of the container 4, which will cause a sudden and painful stretching of the patient's internal organs. The gradual application of the magnetic field can be obtained in two ways:

[0118] A) increasing the applied magnetic field by gradually changing the distance of the external magnetic field source, or

[0119] B) Aliquots of ferromagnetic reagent are gradually introduced into the expandable container 4, with an external magnetic field already applied.

[0120] It will be appreciated that, although the use of a handpiece specifically adapted for such an application is preferred, it is not essential for the proper use of the endoscope guide of the present invention. In practice, the magnetic field source may be located in a plate or other apparatus that is fixed above the bed on which the patient is located, or that can be moved about the bed in a manually or automatically controlled manner. For example, a permanent or electromagnetic magnetic field source may be connected to a movable arm, such as an articulated arm, which may be manually manipulated or its movement may be controlled by means of an electric actuator or even automatically put into operation based on a preselected operating program.

[0121] As mentioned above, the introduction of the ferromagnetic agent is carried out by means of a syringe. The emptying of the container 4 can also be achieved in the same way.

[0122] Figures 1A to 5 A syringe particularly suitable for the purposes of the present invention is shown.

[0123] Such a syringe is indicated as a whole by the reference numeral 5 and comprises a cylinder 7 in which a piston 9 is slidingly inserted and a removable gripping flange 9 .

[0124] The cylinder 7 comprises an open end 7 a into which the piston 8 can be inserted, and a coupling end 7 b opposite the open end 7 a , which is provided with a connector 10 of the connection device 6 having the tubular guide element 1 .

[0125] The open end 7 a of the cylinder 7 comprises an annular shoulder 11 protruding outwards.

[0126] Figure 3 The connector 10 shown in detail in FIG. 1 is preferably of the male “Luer lock” type and comprises a cylindrical sleeve 12 having an internal thread 12 a and a nozzle 13 coaxially arranged inside the cylindrical sleeve 12 .

[0127] The total volume of the column 7 is larger than the filling volume (i.e. the volume occupied by the ferromagnetic reagent) to facilitate the emptying operation. Preferably, when the filling volume is about 25 ml, the total volume is about 35 ml.

[0128] The piston 8 comprises a body 8a extending along a longitudinal axis between a proximal portion 8b and a distal portion 8c and preferably consists of a structure 14 with wings arranged in a cross to reduce friction with the inner wall of the cylinder 7 and to form a rigid structure.

[0129] The proximal portion 8b comprises a push button 15, the size of which is large enough to allow the operator to apply sufficient pressure. For example, the push button 15 may have a size of 40 mm x 25 mm.

[0130] The distal portion 8c comprises a tip 16a, a sealing flange 16b and a stop flange 16c. When the syringe 5 is prefilled with a ferromagnetic agent and assembled, the stop flange 16c is placed flush with the annular shoulder 11 of the cylinder 7, thereby determining the pushed position of the piston 8.

[0131] like Figure 4A and Figure 4B As shown, the gripping flange 9 has a plan shape, for example an oval, and comprises a wing 17 placed along a recess 18 .

[0132] The grip flange 9 further includes a groove 19 surrounding the recess 18 and having a portion 19 a protruding toward the interior of the recess 18 .

[0133] The gripping flange 9 is assembled to the pre-filled syringe by inserting the recess 18 at the open end 7 a of the cylinder 7 , such that the annular shoulder 11 is inserted into the groove 19 .

[0134] like Figure 2 As shown, in addition to forming a gripping surface for the operator's index and middle fingers during operation of the syringe with the thumb placed on the push button 15, the gripping flange 9 also allows the piston 8 to be retained, preventing the piston from being detached from the cylinder 7 by virtue of the abutment between the stop flange 16 c of the cylinder 7 and the protruding part 19 a of the gripping flange 9.

[0135] The grip flange 9 has a sufficiently large size to allow the operator to grip comfortably and safely. For example, the grip flange may have a size of 65 mm×36 mm.

[0136] The syringe 5 may be made of, for example, polycarbonate (e.g., materials) or cycloolefin (co)polymers (respectively referred to as COP and COC).

[0137] The invention also relates to an endoscopy kit comprising an endoscope guide according to the invention, a syringe 5 prefilled with a preset amount of an aqueous suspension of carbonyl iron and optionally a catheter.

[0138] Other variants of the kit according to the invention are:

[0139] A kit comprising a glass bottle filled with a powdered ferromagnetic reagent and a prefilled syringe filled with a saline solution (an aqueous solution of sodium chloride and / or sodium citrate), or

[0140] A kit comprising a glass bottle with a ferromagnetic reagent suspension and an empty syringe.

[0141] In certain embodiments of the kit of the present invention, the syringe 5 is pre-filled with the suspension of ferric hydroxylate, preferably in a volume between 20 ml and 30 ml, more preferably about 25 ml.

[0142] Obviously, the endoscopy system according to the present invention can be operated according to the above method in a completely similar way to the endoscopy system described in EP3399901A1, which is another object of the present invention.

[0143] In essence, it has been discovered how the present invention achieves the tasks and purposes set before it, since it allows providing an endoscopic guide, in particular for colonoscopy, which allows diagnostic analyses or surgical procedures for the removal of colonic lesions to be carried out in a rapid and complete manner, since it is possible to make use of the fact that, by tensioning the guide, the colonoscope can be inserted to the maximum point of the cecum. This tensioning is made possible by the strong anchoring obtainable by the guide of the present invention, which in turn is also a result of the large amount of ferromagnetic agent that can be introduced into the expandable container 4 and the enhanced magnetic field applied from the outside by means of a handpiece or other source of magnetic or electromagnetic fields.

[0144] Furthermore, the endoscopic guide allows at least a small amount of movement of the anchoring head to be performed even when the anchoring head 2 is in the locked position: in fact, in this regard, the operator can use an external magnetic field to move the anchoring head into the appropriate position.

[0145] Furthermore, the operator has at his disposal an endoscopic guide for which it is sufficient to stay in a limited area of ​​the lumen of the organ into which it is introduced, in order to ensure a stable fastening, thus not requiring occlusion of the entire lumen.

[0146] Finally, it has been found that the endoscope guide and the system comprising such a guide are relatively fast to operate and relatively cheap and simple to manufacture. The risk of kinking of the endoscope guide is significantly reduced, and the viscosity of the aqueous suspension of ferric hydroxy is sufficiently low to allow rapid filling and emptying of the expandable container 4 and require limited operator effort. The risk of forming clusters and / or agglomerates of ferromagnetic particles is also reduced.

[0147] Finally, the guide and the system are also relatively safe in the event of a malfunction while performing the examination. Aqueous suspensions of hydroxyferric have low toxicity and are already used in the medical field as iron supplements. This excludes risks to the patient in the event of a loss of the expandable container 4.

[0148] Another advantage of the invention is related to the possibility of more precise localization of lesions, for example in the case of colonoscopy: in fact, it is possible to localize on the abdomen of the patient (topographically) where the colonic lesion is located. In fact, in use, the external handpiece is magnetically coupled to the guide head at the point of the abdominal surface closest to the anchoring head, which can advantageously be used to highlight the position of the lesion relative to the abdominal surface.

[0149] Obviously, only some specific embodiments of the invention have been described here and a person skilled in the art will be able to make all the changes necessary to adapt these embodiments to a specific application without departing from the scope of protection of the invention.

[0150] The materials used, as well as the possible dimensions and shapes, in practice, as long as they are compatible with the specific use intended, may vary according to the requirements and progress of the art.

Claims

1. An endoscopy system, in particular an endoscopy system for colonoscopy, comprising: An endoscope guide, in particular an endoscope guide for a colonoscope, the endoscope guide comprising a tubular guide element (1) and an anchoring head (2), wherein the tubular guide element (1) comprises a longitudinal cavity (3), the anchoring head (2) is provided with an expandable container (4) configured to contain a ferromagnetic agent, the expandable container (4) being connected to the longitudinal cavity (3), wherein the endoscope inspection system further comprises a ferromagnetic agent configured to be movable in the longitudinal cavity to fill / empty the expandable container (4), Characterized in that the ferromagnetic reagent is an aqueous suspension of carbonyl iron.

2. The endoscopic inspection system according to claim 1 further includes a magnetic field source, which is configured to apply a holding force greater than or equal to 5 Newtons to the ferromagnetic agent at a distance between 2 cm and 10 cm from the ferromagnetic agent relative to the lateral pulling direction.

3. The system according to claim 1 or 2, further comprising a syringe (5) pre-filled with the ferromagnetic reagent.

4. The system according to any one of claims 1 to 3, wherein: The purity of the hydroxy iron is greater than or equal to 97.5%, or greater than or equal to 99.5%, and is composed of spherical particles having the following particle size distribution: D10 = 3-4.5 microns, or about 4.1 microns, D50 = 5-10 microns, or about 9.5 microns, D90 = 4-30 microns, or approximately 26 microns.

5. The system according to any one of claims 1 to 4, wherein: The aqueous suspension of carbonyl iron comprises between 45% and 60%, or between 50% and 55%, or between 52% and 53% by weight of carbonyl iron relative to the total weight of the suspension.

6. The system according to any one of claims 1 to 5, wherein: The aqueous suspension of carbonyl iron comprises between 2.5 and 4.5% by weight of trivalent sodium citrate relative to the total weight of the suspension and / or comprises between 5 and 8% by weight of sodium chloride relative to the total weight of the suspension.

7. A system according to any one of claims 1 to 6, wherein: The tubular guiding element (1) has a single lumen and has an outer diameter (D) of less than 2.6 mm or approximately 2.5 mm, and the inner diameter (d) of the lumen of the tubular guiding element (1) is between 1.6 mm and 1.75 mm, or approximately 1.7 mm.

8. The system according to any one of claims 1 to 7, wherein: The expandable container (4) comprises an inflatable balloon, or consists of the inflatable balloon, and the size of the expandable container is designed to have a capacity of 22-28 ml or approximately 25 ml, and when in the expanded state, the length of the expandable container is between 55 mm and 65 mm, or approximately 60 mm, and the transverse diameter is between 20 mm and 30 mm, or approximately 25 mm.

9. The system according to any one of claims 1 to 8, wherein: The syringe (5) comprises a cylinder (7) into which a piston (8) is slidably inserted, and a removable gripping flange (9).

10. The system according to claim 9, wherein: The cylinder (7) comprises an open end (7a) into which the piston (8) can be inserted and a coupling end (7b) opposite the open end (7a), the coupling end being provided with a connector (10) for the tubular guide element (1), wherein the open end (7a) comprises an outwardly protruding annular shoulder (11), and wherein the connector (10) is of the male "Luer lock" type and comprises a cylindrical sleeve (12) having an internal thread (12a) and a nozzle (13) coaxially arranged inside the cylindrical sleeve (12).

11. The system according to claim 9 or 10, wherein: The piston (8) comprises a body (8a) extending along a longitudinal axis between a proximal portion (8b) and a distal portion (8c) and preferably consisting of a structure (14) with wings arranged in a cross shape.

12. The system according to claim 11, wherein: The distal portion (8c) of the piston (8) includes a tip (16a), a sealing flange (16b) and a stop flange (16c), and is configured so that when the syringe (5) is pre-filled with a ferromagnetic agent and assembled, the stop flange (16c) is flush with the annular shoulder (11) of the cylinder (7), thereby determining the pushing position of the piston (8).

13. A system according to any one of claims 10 to 12, wherein: The gripping flange (9) includes a recess (18) and a groove (19), wherein the recess is sized to be coupled to the open end (7a) of the cylinder (7), and the groove surrounds the recess (18) and has a portion (19a) protruding toward the interior of the recess (18), and the groove (19) is configured to be inserted into the annular shoulder (11).

14. An endoscopy kit comprising an endoscope guide according to any one of claims 1 to 8, a syringe (5) according to any one of claims 9 to 13, and optionally a catheter.

15. The kit of claim 14, wherein: The syringe (5) is filled with the carbonyl iron suspension.

16. The kit of claim 14, comprising: A glass bottle filled with a powdered ferromagnetic reagent and a syringe pre-filled with a saline solution (aqueous solution of sodium chloride and / or sodium citrate), or A glass bottle filled with a suspension of ferromagnetic reagent and an empty syringe.

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