Magnetic handpiece for an endoscope, particularly a colonoscope guide, and endoscopy system including said handpiece

Abstract

The present invention relates to a magnetic handpiece for guiding an endoscope, particularly suitable for application in colonoscopy. In particular, the present invention is directed to a magnetic handpiece system (1) comprising a magnetic handpiece (2) and a casing (3). The magnetic handpiece (2) comprises a magnetic field source consisting of one or more permanent magnets. The magnetic handpiece (2) comprises a hollow body having a longitudinal axis (XX), a first end (5a) and a second end (5b), in which a movable support element (6) of the magnetic source is movably accommodated via a threaded connection. The movable support element (6) is movable along the axis (XX) between a raised, i.e. non-operating, position and a number of lowered operating positions.

Description

[Technical field]

[0001] The present invention relates to a magnetic handpiece for an endoscopic guide for a catheter or endoscope, and is particularly suitable for colonoscopy applications.

[0002] Examples of such instruments include colonoscopes, enteroscopes, gastroscopes, duodenoscopes, and echoscopes. [Background technology]

[0003] Endoscopic guides (or "guidewires" in technical terms) are used in particular in the field to position and act as guides for catheters. The catheters are usually slidably mounted over the guidewire. In this regard, the catheter is provided with a working channel in which the guide itself is located with its assembly.

[0004] Various types of endoscopic guides are known from the prior art depending on their intended use.

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

[0006] In this regard, in certain embodiments, the guide comprises an inflatable balloon which, when introduced and positioned within the lumen of the organ, is inflated with air until it interferes with the wall of the lumen itself, thus remaining occluded in place.

[0007] While such guides having expandable anchor heads have been used, they suffer from significant drawbacks.

[0008] Such anchor heads are difficult to use in certain endoscopic fields, for example in the case of colonoscopy, due to the anatomical shape of the organ in which the guide is introduced. Indeed, the diameter of the lumen of the colon can vary from 2-3 cm to 6-8 cm, depending on the part to be examined and the presence or absence of pathological conditions or anatomical abnormalities. This can lead to the need for rather large balloons.

[0009] Furthermore, fixation via the balloon is obtained by friction occurring between the balloon and the surface of the organ mucosa. As a result, lesions may occur in the organ wall. In the case of colonoscopy, the blockage due to friction results in the need to stretch the balloon more and increase the pressure on the organ wall in order to obtain a more stable fixation. However, this maneuver carries the risk of leading to excessive stretching of the organ, causing pain or even tissue tearing. Furthermore, especially in elderly people or in certain pathological conditions, the organ may be distended or relaxed and may not offer resistance to the balloon expansion. In this condition, balloon expansion is not only dangerous but also ineffective.

[0010] However, to ensure reliable operation of the guides in colonoscopes and endoscopes in general, it is necessary to obtain a firm and stable fixation.

[0011] In particular, in colonoscopy, care must be taken when guiding the colonoscope to the end of the colon, because the colon has a tortuous path and loose walls, which can lead to the formation of loops that can impede the progress of the tip of the colonoscope or stretch the walls of the colon, resulting in pain and the risk of lacerating the internal organs. In these cases, the physician must manipulate the instrument in an appropriate manner to clear the path as much as possible and proceed by guiding the colonoscope to the end.

[0012] Many of the problems associated with prior art mounting devices have been overcome by an endoscopy guide and an endoscopy system including the same, as described in European Patent EP3399901A1 to the present applicant. Such patent describes a system for magnetically fixing the tip of an endoscopy guide by introducing a magnetic fluid consisting of an aqueous suspension of iron powder, magnetite, maghemite or ferrofluid into an inflatable balloon. Fixation is obtained by applying a magnetic field of suitable strength from the outside using a magnetic handpiece. Summary of the Invention [Problem to be solved by the invention]

[0013] Although such systems allow adequate fixation to the wall of the colon without obstructing the organ lumen and without damaging the organ tissue, they suffer from various drawbacks.

[0014] In particular, with regard to the magnetic handpiece described herein, it is the result of complex and expensive manufacturing, has excessive weight, and is difficult to shield both during use and when the handpiece is stored. Insufficient shielding of the magnetic field has two drawbacks: it creates the possibility of interference with other devices installed nearby, and it scatters the magnetic field in a direction different from the direction of preferential interaction with the balloon filled with magnetic fluid. It is therefore an object of the present invention to provide a magnetic handpiece system that solves one or more of the technical problems set forth above with regard to known magnetic handpieces.

[0015] In particular, it is an object of the present invention to produce a magnetic handpiece system that is relatively affordable and easy to manufacture, yet is quick and easy to operate, and is small in size and weight. [Means for solving the problem]

[0016] To achieve one or more of the objectives and aims set out above, as well as other objectives identified below, This is achieved by a magnetic handpiece system comprising a magnetic handpiece and a casing, the magnetic handpiece having a magnetic field source consisting of one or more permanent magnets, the magnetic handpiece having a hollow body portion having a longitudinal axis, a first end and a second end, in which a movable support element of the magnetic source is movably accommodated via a threaded connection, the movable support element being movable along the longitudinal axis between a raised position, i.e., a non-operating position, and a plurality of lowered operating positions.

[0017] Other objects of the present invention are as follows:

[0018] 2) The system according to point 1), wherein the body part comprises an upper closure element having a central sleeve part with an axial opening into which a shaft is inserted, the inner end of the shaft being connected to the movable support element and the outer end of the shaft being connected to a handle, the handle preferably having a helical shape, for example in a clockwise direction, making the correct direction of rotation for screwing and unscrewing the movable support element more intuitive and thus increasing or decreasing the applied magnetic attractive force.

[0019] 3) The system described in points 1) or 2), wherein the movable support element comprises a hollow cylindrical portion having an external thread and an inner surface including a plurality of ribs, the hollow cylindrical portion defining a hollow interior configured to accommodate the magnetic source, and the body portion having threads on its inner surface that can be coupled to the threads of the movable support element.

[0020] 4) The magnetic source has a magnetization equivalent to that of a disk-shaped permanent magnet of magnetization grade N52, with a diameter of 70 to 90 mm, a thickness of 30 to 60 mm, and a weight of 1.8 to 2.8 kg; a) an axially magnetized cylindrical magnet; b) a Halbach array type configuration in which multiple magnets, preferably eight magnets, are arranged coronally around a cylindrical central magnet; c) a Halbach array type configuration having four magnets arranged along the sides of a parallelepiped central magnet, i.e., peripherally with respect to said central magnet; d) a Halbach array type configuration with two magnets sandwiched along two sides of a parallelepiped central magnet; is selected from In configuration b), the central magnet is arranged with an axial polarization, while the crown magnets have polarizations arranged along pole lines converging toward the longitudinal axis of the central magnet; In configuration c), the central magnet is arranged with its magnetization axially, while the four peripheral magnets are magnetized parallel to a plane perpendicular to the magnetization direction of the central magnet; In configuration d), the central magnet and the two sandwiched magnets are arranged with their magnetizations aligned along directions at 90° to each other. A system according to any one of points 1) to 3).

[0021] 5) The magnetic source according to configuration a) comprises a magnet having dimensions of approximately D85-86 mm x Sp45-45.5 mm, and the total weight of the magnetic source is approximately 2 kg; The magnetic source according to configuration b) consists of a central magnet with a diameter of about 74 mm and a thickness of about 35 mm and eight parallelepiped magnets with dimensions of about Lc15 x Lu26 x Sp35 mm, the total weight of the magnetic source being about 2 kg, the eight magnets in the form of a crown being spaced about 1 mm from the central magnet, The magnetic source according to configuration c) comprises a central magnet with dimensions Lc=Lu60-61mm×Sp35-44mm and four peripheral magnets with dimensions Lc15-16×Lu60-61×Sp35-44mm, and the total weight of the magnetic source is 2-2.5kg; The magnetic source according to configuration d) comprises a central magnet with dimensions of approximately Lc44 x Lu45 x Sp58 mm and two sandwiched magnets with dimensions of approximately Lc28-16 x Lu45 x Sp58 mm, the total weight of the magnetic source being approximately 2 kg; Lc is the short side, Lu is the long side, Sp is the thickness, and D is the diameter of the base of the cylinder. The system described in point 4).

[0022] 6) A system according to any one of points 1) to 5), in which the magnetic handpiece has a magnetic field concentrating element obtained by using a ferromagnetic material shield arranged along the wall of the movable support element or the body part, optionally above the magnetic source, in the form of a plurality of plates or as a continuous or discontinuous annular band, which may consist of a single sheet or of a plurality of sheets of ferromagnetic material arranged in contact or spaced relation.

[0023] 7) The system according to point 6), wherein the ferromagnetic material is a metal alloy containing 76-80%, or about 80%, nickel, about 14.5-15% iron, 3-6% or about 5% molybdenum, 4-55% copper, and trace amounts of silicon.

[0024] 8) A system according to any one of points 1) to 7), wherein the casing comprises a storage shell arranged on a stand having a base and a pole, the base preferably having wheels, the storage shell having a basket and a lid with a handle, the lid being hinged to the basket with two hinges arranged at diametrically opposite points, the lid and optionally also the basket being shaped like a spherical cap, such that the storage shell as a whole is substantially spherical or semi-oval.

[0025] 9) The system according to point 8), wherein the basket has a toroidal body, preferably hollow inside to form a space, the toroidal body including a central seat sized to accommodate the magnetic handpiece.

[0026] 10) A system as described in points 8) or 9), wherein a catch having an inclined bar hinged at its midpoint to a ridge located on the surface is located on the outer surface of the basket near the top edge, and first and second retainer teeth are located proximate to the two ends of the bar, the first retainer tooth being configured to snap-fit ​​into a seat recessed in the surface of the basket, and the second retainer tooth being configured to engage a ridge located along the edge of the lid in a central position relative to the hinge.

[0027] 11) A system according to any one of points 8) to 10), wherein the basket has a magnetic field shielding element made of a ferromagnetic material plate, preferably a metal alloy containing 76-80% or about 80% nickel, about 14.5-15% iron, 3-6% or about 5% molybdenum, 4-55% copper and traces of silicon, and the total thickness of the shielding element is preferably 3 mm to 6 mm.

[0028] 12) The system according to point 11), wherein the shielding element comprises an annular sheet and a number of U-shaped sheets configured to also cover the bottom of the basket, the shielding element being preferably housed in the space inside the toroidal body.

[0029] 13) A magnetic handpiece defined in any one of points 1) to 7).

[0030] 14) A casing for a magnetic handpiece as defined in any one of points 8) to 12).

[0031] 15) An endoscopy kit comprising: A magnetic handpiece defined in any one of points 1) to 7); an endoscope guide having a tubular guide element and an anchor head, the tubular guide element having a longitudinal cavity, the anchor head comprising an expandable container configured to contain a ferromagnetic agent; A pre-filled syringe filled with a preset amount of an aqueous suspension of a ferromagnetic agent, or a glass vial filled with a powdered ferromagnetic agent, preferably carbonyl iron, and a pre-filled syringe filled with saline (aqueous solution of NaCl and / or sodium citrate), or a glass vial with a suspension of a ferromagnetic agent, preferably carbonyl iron, and an empty syringe. An endoscopy kit comprising:

[0032] The present invention further relates to an endoscopic system, preferably for colonoscopy, which has an endoscopic guide acting in cooperation with an external magnetic field source, the magnetic field source being associated with a manually operable device, i.e. without any moving device or auxiliary support, the manually operable device being a magnetic handpiece in which the magnetic field source is movable between an active position and a safe or rest position, in which in the active position the magnetic field source is close to the operating end of the handpiece and in which in the safe or rest position the magnetic field source is far from the operating end of the handpiece.

[0033] Further features and advantages will become apparent from the description of preferred, but not exclusive, embodiments of the invention illustrated by way of non-limiting examples. [Brief description of the drawings]

[0034] [Figure 1] FIG. 1 is a side view of a magnetic handpiece according to the present invention. [Diagram 2] FIG. 2 is a cross-sectional view of the magnetic handpiece taken along line II in FIG. [Diagram 3] FIG. 3 is a top view of the handle of the magnetic handpiece of FIG. [Figure 4] FIG. 4 is a bottom perspective view of a detail of the magnetic handpiece of FIG. 1; [Figure 5A] FIG. 5A illustrates a perspective view of a first configuration of a magnet according to the present invention. [Figure 5B] FIG. 5B illustrates a plan view of a first configuration of magnets according to the present invention. [Figure 6A] FIG. 6A illustrates a perspective view of a second configuration of a magnet according to the present invention. [Figure 6B] FIG. 6B illustrates a plan view of a second configuration of magnets according to the present invention. [Figure 7A] FIG. 7A illustrates a perspective view of a third configuration of a magnet according to the present invention. [Figure 7B] FIG. 7B illustrates a plan view of a third configuration of magnets according to the present invention. [Figure 9]Figure 9 is a schematic representation of the magnetic field lines with and without side shields. [Figure 10] FIG. 10 is a side view of the handpiece of FIG. 1, showing through the magnetic field focusing system. [Figure 11] FIG. 11 is a side view of the casing of the magnetic handpiece of FIG. [Figure 12] FIG. 12 is a cross-sectional side view of the casing of FIG. 11 having a magnetic handpiece of the present invention. [Figure 13] FIG. 13 shows a cross-sectional side view of a detail of the casing of FIG. [Figure 14] FIG. 14 shows a top cross-sectional view of the detail of FIG. [Figure 15] FIG. 15 shows a perspective view of another detail of the casing of FIG. [Figure 16] FIG. 16 shows a perspective cross-sectional view of the detail of FIG. 13 having the magnetic handpiece of FIG. 1 therein. [Figure 17] FIG. 17 shows a side view of another detail of the casing of FIG. [Figure 18] FIG. 18 shows a perspective view of a modified casing for a magnetic handpiece. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] To better understand the present invention, it is first useful to explain how a diagnostic colonoscopy is performed.

[0036] 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 movable and houses the camera, the light, and the orifice of the operating channel. The tip can be manipulated by moving a knob located on the manipulator. The body is flexible and can be selected in certain models to perform certain endoscopic operations. The cables transmitting the images, the power supply, and the tie rods connecting the knob to the tip slide inside the body.

[0037] In addition to a knob for orienting the tip, the manipulator is also characterized by an external orifice for the manipulation channel, and by controls for aspirating or blowing air, and for recording images or videos.

[0038] Diagnostic colonoscopy aims to examine the entire surface of the colon mucosa to identify pathological changes that may require further diagnostic or therapeutic intervention. The tip of the colonoscope, equipped with a camera and a light, needs to reach the last part of the large intestine, called the cecum. If the instrument does not actually reach the cecum, the doctor cannot see if there are pathological changes in the unexplored part.

[0039] Positioning of the colonoscope is accomplished by an endoscope guide, which extends from the distal end of the colonoscope and moves forward into the lumen of the colonoscope to guide its passage until it has advanced as deeply as possible. Similar procedures are performed for introducing other endoscopes as well as for introducing catheters into the venous system.

[0040] The large intestine is a mobile, hollow, tube-like, loose-walled organ: unlike other hollow, tubular organs, such as the arteries, it has a large diameter, its walls can stretch for several centimetres, and in certain parts the organs can be mobile, sometimes up to 30 centimetres, into the abdominal cavity.

[0041] Such anatomical features prevent the insertion of catheters or guides in sections longer than 10-30 cm. In fact, when a catheter is inserted into the rectum via the anus, it has a tendency to roll up on itself due to the large diameter of the lumen and the curvature of the viscera. Thus, unlike what is done in the field of blood vessels, catheterization of the large intestine is difficult to perform unless it is a short section. Catheters and endoscopic guides do not have sufficient mobility or sufficient resistance at the tip, even during X-ray examination. The resistance of an endoscope, catheter, or endoscopic guide means the ability to transmit thrust from the body of the instrument to the tip. The more rigid the endoscope, the higher the resistance. However, an endoscope that is too rigid cannot be easily maneuvered along the tortuous path of the large intestine. Colonoscopes are designed to be a compromise between sufficient flexibility and sufficient resistance.

[0042] However, if the colonoscope is excessively bent, its strength will gradually decrease. For example, if the colonoscope forms a loop during a colonoscopy, the colonoscope cannot transmit thrust from the body to the tip, and the endoscopist cannot advance the instrument and its camera further. In such a case, if the endoscopist pushes the instrument by hand, it will only transmit force to the wall of the organ, causing pain and risk of trauma, and the tip will not advance.

[0043] To overcome this drawback, an endoscope guide was proposed in the above-mentioned patent EP 3 399 901 A1 to the applicant, which makes it possible to carry out a method for introducing a colonoscope, said method comprising the steps of: introducing a distal end of a colonoscope through the patient's anus until a point of obstruction is reached, i.e., a point at which the colonoscope cannot be advanced; advancing the endoscopic guide to a distance of 4-10 cm past the distal end of the colonoscope; introducing a magnetic or ferromagnetic material into the expandable vessel of the endoscope guide such that the vessel reaches an expanded state; applying an external magnetic field by a magnetic field source to the region of the abdomen where the expandable container having the magnetic or ferromagnetic agent is located, attracting the container to a fixed point on the wall of the colon with a holding force of the magnetic or ferromagnetic agent of at least 5 Newtons in a lateral pulling direction; tensioning the endoscopic guide by applying a pulling force of at least 5 Newtons to a proximal end of the endoscopic guide; advancing the colonoscope to a fixation point on the container; repeating the above steps until a fixation point in the cecum is reached. Contains:

[0044] Pulling the endoscopic guide is intended to keep the guide tensioned, thus at least partially reducing the curvature of the colonic loop, even in this case, to facilitate sliding of the endoscope and facilitate the introduction of a relatively stiff endoscope.

[0045] As mentioned above, when carrying out the above mentioned method, the endoscopy system described in EP 3399901 A1 highlighted some important problems which made its use disadvantageous for diagnostic applications.The present invention was therefore born out of the need to overcome such important problems.

[0046] An endoscopy system with which the magnetic handpiece system of the present invention cooperates is an endoscopy guide, particularly for a colonoscope, comprising a tubular guide element and an anchor head, the tubular guide element having a longitudinal cavity, the anchor head comprising an expandable container configured to house a ferromagnetic agent, the expandable container being in communication with said longitudinal cavity, and the endoscopy system further comprising a ferromagnetic agent configured to be movable within said longitudinal cavity to fill / empty the expandable container.

[0047] The expandable container 4 is expandable and contractible manually, preferably elastically, so as to switch from a contracted state in which it is substantially attached to the body portion of the tubular guide element to an expanded state in which it protrudes externally from the body portion of the tubular guide element, or vice versa, and is switched from the contracted position to the expanded position, or vice versa, by filling or emptying the expandable container with a ferromagnetic agent.

[0048] The expandable container comprises or alternatively consists of an expandable balloon. Examples of expandable balloons are those commonly used in endoscopy, such as nylon balloons or balloons made of polyether-polyamide block copolymers or composites with polyamides. Such copolymers with polyamides and their compounds are known and described in detail in patent publication WO2007 / 132485A1.

[0049] In a preferred embodiment, the expandable container is sized to have a volume of 22-28 ml, more preferably about 25 ml, a length of 55-65 mm, more preferably about 60 mm, and a transverse diameter of 20-30 mm, more preferably about 25 mm, when in the expanded state, so as not to obstruct the lumen of the large intestine, which varies in diameter between 3 and 7 cm depending on the cross-section observed.

[0050] The ferromagnetic agents most suitable for the purposes of the present invention are aqueous suspensions of so-called carbonyl iron, or suspensions of magnetite or maghemite, although so-called ferrofluids can also be used.

[0051] Carbonyl iron is a high purity iron (97.5% for grade S and at least 99.5% for grade R) prepared by chemical decomposition of purified pentavalent carbonyl iron. It usually appears as a gray powder consisting of spherical particles. Most of the impurities are carbon, oxygen, and nitrogen. Its most common uses are in powder metallurgy, metal injection molding, and various specialty products. Carbonyl iron powder is used medicinally to treat iron deficiency and as an iron food supplement due to its low toxicity.

[0052] For the purposes of the present invention, the particle size profile is preferably D10=3-4.5 microns, more preferably about 4.1 microns; D50=5-10 microns, more preferably about 9.5 microns; D90 = 4-30 microns, more preferably about 26 microns Carbonyl iron is used.

[0053] The particle size of the ferromagnetic particles is Direct observation using an electron microscope, Measurement by the method of "laser light scattering" of aqueous suspensions using a particle size laser analyzer (Malvern Mastersizer 3000) and the LALLS (low angle laser light scattering) technique using Fraunhofer calculation theory. etc. can be measured by known methods.

[0054] The aqueous suspension of carbonyl iron according to the present invention is preferably a suspension in which carbonyl iron is present in purified water at 45% to 60% by weight, preferably 50% to 55% by weight, more preferably 52% to 53% by weight, based on the total weight of the suspension. Preferably, the aqueous suspension further contains 2.5% to 4.5% by weight of tribasic sodium citrate based on the total weight of the suspension, and / or 5% to 8% by weight of sodium chloride based on the total weight of the suspension.

[0055] The tribasic sodium citrate aids in the dispersion of the carbonyl iron particles in the suspension.

[0056] Sodium chloride acts to inhibit bacterial growth.

[0057] The aqueous suspension of carbonyl iron is preferably degassed to avoid oxidation processes of the iron due to oxygen absorbed in the water.

[0058] The use of the aqueous suspension of carbonyl iron according to the invention is mentioned to have several advantages over known solutions, namely: i) an increased magnetic response, which allows the use of less aqueous suspension and therefore less filling of the expandable container 4; ii) the particles are spherical, resulting in a lower viscosity aqueous suspension, reducing the risk of cluster and / or agglomerate formation; iii) Carbonyl iron is widely available in the market, has moderate cost and low toxicity, making it suitable for pharmaceutical use.

[0059] In particular, such properties, especially the increased magnetic response, provide the greatest synergistic effect in the magnetic handpiece of the present invention, in other words, when the ferromagnetic agent is an aqueous suspension of carbonyl iron as defined above, the magnetic handpiece of the present invention provides the best performance in terms of fixing the head of the endoscope guide.

[0060] Next, a magnetic handpiece system according to the present invention will be described. The magnetic handpiece system is generally designated by reference numeral 1 and comprises a magnetic handpiece 2 and a casing 3.

[0061] The magnetic handpiece 2 comprises a magnetic field source configured to apply a holding force to the ferromagnetic agent of greater than 5 Newtons in a transverse pulling direction at a distance of between 2 centimeters and 10 centimeters.

[0062] The term "applying a holding force to a ferromagnetic agent against a transverse pulling direction" means a holding force on the ferromagnetic agent against a pull that is substantially perpendicular to the direction of maximum attractive force between the magnet and the ferromagnetic material as determined by the field lines of the magnetic field.

[0063] The holding force of the expandable container against the wall of the colon, which should be greater than 2 Newtons or greater than 5 Newtons in the transverse pulling direction to allow sufficient pulling of the endoscope guide as mentioned above, depends on both the amount of ferromagnetic agent in the container and the applied magnetic field, which depends on the distance from the source of the magnetic field to the container filled with ferromagnetic agent. Usually, such a distance is 1-5 cm for most colonic segments. However, this distance is larger in obese patients, for example up to 10 cm.

[0064] The magnetic field source according to the invention consists of one or more permanent magnets. For the purposes of the invention, it is possible to use a magnetic field equivalent to that produced by a disk-shaped permanent magnet of magnetization grade N52 (i.e. a magnet with a maximum magnetic energy per volume that can be stored in the magnet of 52 Megagauss Orsted) with a diameter of 50-100 mm, a thickness of 30-80 mm and a weight of 1.8-4.5 kg. The permanent magnet can be made of sintered neodymium, sintered ferrite, plasted neodymium, etc.

[0065] In particular, by way of example, the following magnetic source configuration can be used (FIGS. 5A-8B): 1) A Halbach array type configuration having multiple magnets 4', preferably eight magnets 4' arranged coronally around a cylindrical central magnet 4 (FIGS. 5A and 5B). 2) A Halbach array type configuration, with four magnets 4' arranged along the sides of a parallelepiped central magnet 4, i.e. peripherally with respect to said central magnet 4 (FIGS. 6A and 6B). 3) A Halbach array type configuration, with two magnets 4' arranged in a sandwiched fashion along two sides of a parallelepiped central magnet 4 (FIGS. 7A and 7B). 4) Cylindrical magnet 4 (Figures 8A and 8B). The direction of the magnetic field is also indicated by arrows in Figures 5A, 6A, 7A and 8A.

[0066] especially, In configuration 1), the central magnet 4 is arranged with an axial polarization, while the crown magnets 4' have polarizations arranged along curves converging towards the longitudinal axis of the central magnet 4; In configuration 2), the central magnet 4 is arranged with its magnetization in the axial direction, while the four peripheral magnets 4' are magnetized parallel to a plane perpendicular to the magnetization direction of the central magnet 4; In configuration 3), the central magnet 4 and the two sandwiched magnets 4 are arranged in a state where they are magnetized along directions at 90° to each other, In configuration 4), the magnet 4 is axially magnetized.

[0067] In a preferred embodiment, the magnetic source according to configuration 1) consists of a central magnet 4 with a diameter of about 74 mm and a thickness of about 35 mm, and eight parallelepiped magnets 4' with dimensions of about Lc15xLu26xSp35 mm (Lc is the short side, Lu is the long side and Sp is the thickness), the total weight of the magnetic source being about 2 kg, the eight coronal magnets 4' being spaced about 1 mm from the central magnet 4. This latter feature allows the optimization of the capacity of magnetic attraction relative to the weight of the magnets.

[0068] In a preferred embodiment, the magnetic source according to configuration 2) comprises a central magnet 4 having dimensions L60-61 mm × Sp35-44 mm and four peripheral magnets 4' having dimensions Lc15-16 × Lu60-61 × Sp35-44 mm, and the total weight of the magnetic source is 2 to 2.5 kg.

[0069] In a preferred embodiment, the magnetic source according to configuration 3) consists of a central magnet 4 with dimensions of approximately Lc44xLu45xSp58mm and two sandwiched magnets 4' with dimensions of approximately Lc28-16xLu45xSp58mm, the total weight of the magnetic source being approximately 2kg.

[0070] In a preferred embodiment, the magnetic source according to configuration 4) consists of a magnet 4 with dimensions of approximately D85-86mm x Sp45-45.5mm (D being the diameter of the bottom of the cylinder) and the total weight of the magnetic source is approximately 2kg.

[0071] In a preferred embodiment, the step of applying the magnetic field may be performed by applying such a magnetic field in a stepwise manner. Indeed, if the required magnetic field were applied too quickly, the container 4 would move suddenly and the patient's internal organs would be stretched suddenly and painfully. The stepwise application of the magnetic field may A) Increasing the applied magnetic field by gradually changing the distance of the external magnetic field source; B) Gradually introducing an aliquot of the ferromagnetic agent into the expandable container 4 with the external magnetic field already applied. It can be obtained in two ways:

[0072] This magnetic field source is contained in a handpiece particularly adapted for this application which is the subject of the present invention and is described below.

[0073] The magnetic handpiece 2, as shown in Figures 1 to 4, comprises a hollow body 5 having a longitudinal axis XX, a first end 5a and a second end 5b, in which a movable support element 6 of the magnetic source is movably accommodated via a threaded connection, the movable support element 6 being movable along the axis XX between a raised or non-operating position and a plurality of lowered operating positions.

[0074] In other words, the movable support element 6 can be positioned in an operating position adjacent to the second end 5b of the body portion 5 (where maximum magnetic attraction force is obtained on the support surface of the handpiece 2), or in a number of intermediate operating positions between the first end 5a and the second end 5b of the body portion 5.

[0075] The body 5 is provided at its top with a closure element 7 having a central sleeve portion 7a with an axial opening 7b into which a shaft 8 is inserted. The shaft 8 is connected at its inner end 8a to the movable support element 6 and at its outer end 8b to a handle 9. In a particular embodiment, as shown in Figures 1 and 3, the handle 9 has a helical shape, for example in a clockwise direction, making the correct rotation direction for screwing and unscrewing the movable support element 6 more intuitive and thus increasing or decreasing the applied magnetic attractive force.

[0076] The body 5 and the closure element 7 can be made of two separate parts, as shown in the drawings, but can also be made of one integral piece.

[0077] The movable support element 6, as shown in FIG. 4, has a hollow cylindrical portion 6a and a sleeve portion 6b in which the shaft 8 is received and fixed.

[0078] The hollow cylindrical portion 6a has an external thread 10 and its inner surface has a number of ribs 11, the function of which is to increase the contact surface with the magnet.

[0079] The hollow interior 12 is configured to house a magnetic source which may be, for example, a single magnet 4 or one of the Halbach configurations described above.

[0080] The body 5 is provided on its inner surface with a thread 13 which can be coupled to the thread 10 of the movable support element 6 .

[0081] This allows the movable support element 6 to be screwed or unscrewed into the internal threads 13 of the body portion 5 by rotating the shaft 8 by means of the handle 9, so that the magnetic source moves closer to or away from the second end 5b of the body portion 5 (or vice versa depending on the direction of the threads).

[0082] The axis is equipped with a graduated scale, which indicates the selected magnetic field strength level after turning the handle. Providing the scale on the axis makes it easier to see and also more convenient from an assembly point of view. Rotating the handle 9 reduces the height of the axis, so that the magnet descends. This phenomenon makes the height position of the selected magnet more clear and reduces the risk of possible errors when adjusting the magnetic field strength.

[0083] The outer shell of the handpiece may be wholly or partially transparent to facilitate viewing of the magnet or to facilitate examination of the patient's skin on which the handpiece is placed, the latter point being advantageous for identifying possible phenomena of transillumination.

[0084] Transillumination means that the light from the colonoscope can be seen through the patient's skin, which indicates a thin abdominal wall and also allows for precise identification of the location of the tip of the endoscope relative to the abdominal surface.

[0085] In certain embodiments, the magnetic handpiece 2 comprises a magnetic field concentrating element 14 (schematically shown in FIG. 10). The magnetic field concentrating element 14 is made by a ferromagnetic material shield arranged above the magnetic source and along the wall of the movable support element 6 or the body 5, for example in the form of a plurality of plates or a continuous or discontinuous annular band. In other embodiments, the magnetic field concentrating element 14 is arranged only along the wall of the movable support element 6 or the body 5.

[0086] The magnetic field concentrating elements 14 may be embedded in the material from which the body 5 or the movable support element 6 is made, or may be disposed along a surface thereof.

[0087] Magnetic field concentrating element 14 may consist of a single sheet of ferromagnetic material, or it may consist of multiple sheets arranged in contact or spaced apart relation.

[0088] FIG. 9 shows, by way of example, how the magnetic field is distorted by the magnetic field concentrating element 14 (on the right) relative to the unshielded magnetic field (on the left). As can be seen, the presence of the magnetic field concentrating element 14 reduces the spread of the magnetic field lines in the lateral direction and concentrates them in the direction of operation of the magnetic handpiece 2. This increases the magnetic attraction to the balloon filled with ferromagnetic material inserted in the organ to be analyzed, and thus the efficiency of the magnetic source, while reducing the possibility of interference with nearby devices or objects. The efficiency of the shielding depends on the magnetic permeability of the material from which the magnetic field concentrating element 14 is made. A preferred material is a metal alloy containing 76-80% or about 80% nickel, about 14.5-15% iron, 3-6% or about 5% molybdenum, 4-55% copper, and traces of silicon. Such alloys are sold, for example, under the trade names Mumetal, Cryoperm, Vacoperm, Ultraperm.

[0089] The invention further relates to a magnetic handpiece system 1 comprising a magnetic handpiece 2 as described above and a casing 3 for said magnetic handpiece 2 .

[0090] The casing 3 is a critical element as it must allow the magnetic handpiece 2 to be safely stored when not in use, and to be quickly and easily removed and reinserted during the operating steps.

[0091] The casing 3, shown in Figures 11-18, has a containment shell 15 disposed on a stand 16 having a base 16a and a pole 16b. As shown in Figure 18, the base 16a preferably has wheels 17 to allow the casing 3 to be easily moved by an operator.

[0092] The height of the stand 16 is such that the handpiece 2 housed within the casing 3 can be easily grasped by any operator without the operator having to bend down significantly to reach it. However, the height of the stand 16 has been made as low as possible to lower the center of gravity of the device and reduce the risk of tipping over. Furthermore, the low carriage allows the handpiece 2 to be easily seen and grasped from all sides.

[0093] The storage shell 15 comprises a basket 18 and a lid 19 hinged to the basket 18. Advantageously, the basket 18 and the lid 19 are shaped like a spherical cap so that the storage shell 15 as a whole is substantially spherical. The lid 19 has two hinges 20 located at diametrically opposed points. This allows the lid 19 to be opened and closed easily with one hand by moving the associated spherical cap over the basket 18. This limits the overall size of the lid when opened and avoids the impact that may result from accidentally closing the lid, as compared to conventional lids that have hinges at their ends. Conventional lids require space to tip over if tipped over. For example, opening only 90 degrees limits the angle at which the operator can access the handpiece. Instead, the spherical lid allows the handpiece to be grasped from any position. Finally, once opened, the spherical lid remains open under the force of gravity and there is no risk of it closing accidentally if the carriage is knocked.

[0094] To this end, the lid 19 has a handle 21 that facilitates movement of the lid (when the lid is released) and the carriage (when the lid is closed and locked).

[0095] Additionally, the lid features a shield in close proximity to the inner surface. Such shields are ferromagnetic and may attract magnets when the handpiece is removed. To limit this phenomenon, current lids were designed so that the underside of the lid always remains hidden and the top surface is 4-5 cm away from the screen. This distance prevents accidental smacking of the handpiece onto the lid, as the magnet's attraction is weaker when it approaches. Such a smacking could lead to damage to the device or even harm to the operator if his hand gets in the way. Also, the screen within the casing was designed to be 4-5 cm away from the outer surface to limit the magnetic attraction between the handpiece and the shield.

[0096] In a particular embodiment, the basket 18 is semi-oval shaped and the lid 19 is shaped like a spherical cap.

[0097] The basket 18 has a sleeve 22 at its bottom for connection with the pole 16b and a toroidal body 23 which is preferably hollow inside to form a space 25. This allows the structure to be lightweight.

[0098] The toroidal body 23 has a central seat 24 sized to accommodate the magnetic handpiece 2, as shown in Figures 12 and 16. The central seat 24 is conical in shape to facilitate repositioning and centering of the handpiece 2 and to limit the risk of accidental banging of the handpiece 2 during repositioning within the casing.

[0099] The central seat 24 is configured to always keep the handpiece 2 vertical, which has the following advantages.

[0100] The magnetic field on the side of the handpiece is weaker and has less spatial spread. The operator places the handpiece in a position that is easy to grasp and in the correct position for use during endoscopic procedures. The casing prevents the hand from accessing the body of the handpiece, the part that contains the magnet, which may cause a risk of hand crushing. Therefore, the casing promotes the operator's correct grip of the handpiece by gripping the handle or shaft alone.

[0101] A catch 26 having an inclined bar 26a hinged at its midpoint to a ridge 27 located on the surface 18a of the basket 18 in a position adjacent to the upper edge 18b. First and second retainer teeth 28a, 28b are located adjacent to the two ends of the bar 26a. The first retainer tooth 28a is configured to snap into a seat 29 recessed in the surface 18a of the basket 18, while the second retainer tooth 28b is configured to engage a ridge 30 located along the edge 19a of the lid 19 in a central position relative to the hinge 20. The catch 26 is designed to be operated with one hand and has two stop positions, one corresponding to an open position of the lid 19, preventing the catch 26 from preventing its opening, and the other corresponding to a closed position, keeping the lid 19 closed on the basket 18.

[0102] In a preferred embodiment, as shown in Figure 16, the basket 18 has a magnetic field shielding element 31. When the magnetic handpiece 2 is housed within the casing 3, the shielding element 31 prevents (or at least reduces the risk of) its magnetic field extending outwards and interfering with externally located devices.

[0103] The shielding element 31 consists of a plate of ferromagnetic material, preferably a metal alloy as described above containing 76-80% or about 80% nickel, about 14.5-15% iron, 3-6% or about 5% molybdenum, 4-55% copper, and trace amounts of silicon.

[0104] In a particular embodiment, the shielding element 31 has an annular seat 31 a and a number of U-shaped seats 31 b configured to also cover the bottom of the basket 18 .

[0105] The lid 19 has a full surface that is wide enough to accommodate the shielding element 31 and ensure a clearance of at least 4-5 cm from the edges as well as from the top surface.

[0106] To ensure that the lid 19 is fully opened and leaves the entire central seat 24 of the handpiece 2 accessible from all sides, the lid 19 is recessed in its rear part (opposite the catch 26) so that the axis of the casing does not prevent the lid 19 from being fully opened.

[0107] The shielding element 31 is preferably housed in the space 25 inside the toroidal body 23 .

[0108] There is a silicone pad on the bottom of the handpiece housing to limit shock to the handpiece 2 when it is stationary or when the casing is moving. Since the pad is only on the bottom, it is easy to remove and clean.

[0109] The total thickness of the shielding element 31 is preferably between 3 mm and 6 mm.

[0110] The conical shape of the central seat 24 therefore facilitates centering of the handpiece 2 with respect to the casing shield and also the outer surface of the carriage, thereby limiting the spread of the magnetic field to the external environment.

[0111] The present invention further relates to an endoscopy kit comprising a magnetic handpiece 2 according to the present invention, an endoscopy guide as described in EP 3399901 A1, a pre-filled syringe filled with a preset amount of an aqueous suspension of a ferromagnetic agent, and optionally a catheter.

[0112] In a particular embodiment of the kit of the invention, the syringe is pre-dosed with a suspension of said ferromagnetic agent, preferably in a volume of 20-30 ml, more preferably about 25 ml, said ferromagnetic agent being carbonyl iron.

[0113] In an alternative embodiment, the kit of the present invention comprises: A glass vial filled with a powdered ferromagnetic agent, preferably carbonyl iron, and a pre-filled syringe filled with saline (aqueous solution of NaCl and / or sodium citrate), or A glass vial filled with a suspension of a ferromagnetic agent, preferably carbonyl iron, and an empty syringe; It has.

[0114] Obviously, the endoscopy system according to the invention can operate in exactly the same way as the endoscopy system described in EP 3399901 A1 according to the above mentioned method, which is a further object of the present invention.

[0115] In summary, it has been found how to achieve the preset task and object, since the present invention makes it possible to provide a magnetic handpiece 2 capable of obtaining a strong fixation that is the result of a synergistic effect obtained by a substantial amount of ferromagnetic agent that can be introduced into the expandable container of the endoscope guide and an increased magnetic field that can be applied externally by said magnetic handpiece 2. This synergistic effect is particularly evident when the ferromagnetic agent is carbonyl iron.

[0116] Moreover, the magnetic handpiece system 1 according to the present invention is easy and inexpensive to manufacture, and yet quick and safe to use. In particular, the casing 3 can be opened and closed with one hand, leaving the operator's other hand free. The attractive force of the magnetic handpiece 2 can be easily adjusted by rotating the handle 9 in a clockwise or counterclockwise direction to move the magnetic field source closer or further away, respectively, from the patient's abdominal surface (or vice versa, according to the direction of the screw). Shielding of the casing and magnetic field concentrating elements of the magnetic handpiece reduces magnetic interactions with objects or devices other than in the direction of use.

[0117] Although only some specific embodiments of the invention have been described, it is clear that a person skilled in the art can make all the modifications necessary to adapt it to a particular application, without departing from the scope of protection of the invention.

[0118] In practice, the materials used, as well as incidental dimensions and shapes, may vary according to the demands and advances of the art, provided they are suited to a particular application.

Claims

1. A magnetic handpiece system (1) comprising a magnetic handpiece (2) and a casing (3), wherein the magnetic handpiece (2) has a magnetic field source consisting of one or more permanent magnets, the magnetic handpiece (2) has a hollow body portion (5) having a longitudinal axis (X-X), a first end (5a), and a second end (5b), a movable support element (6) of the magnetic source is movably housed within the hollow body portion (5) via a screw connection, and the movable support element (6) is movable along the axis (X-X) between an elevated position, i.e., a non-operating position, and a plurality of lowered operating positions.

2. The body portion (5) is provided with a closing element (7) at its top having a central sleeve portion (7a) including an axial opening (7b) into which a shaft (8) is inserted, the inner end (8a) of the shaft (8) is connected to the movable support element (6), and the outer end (8b) of the shaft (8) is connected to a handle (9), the handle (9) preferably has a spiral shape, for example in a clockwise direction, to make the correct rotational direction for screwing in and unscrewing the movable support element (6) more intuitive and thus increase or decrease the applied magnetic attraction force. The system (1) according to claim 1.

3. The movable support element (6) comprises a hollow cylindrical portion (6a) having an outer thread (10) and an inner surface including a plurality of ribs (11), the hollow cylindrical portion (6a) defines a hollow interior (12) configured to house the magnetic source, and the body portion (5) has a thread (13) on its inner surface that can be coupled to the thread (10) of the movable support element (6). The system (1) according to claim 1 or 2.

4. The magnetic source has a magnetization equivalent to that of a disc-shaped permanent magnet with a magnetization grade of N52, having a diameter of 50 mm to 100 mm, a thickness of 30 mm to 80 mm, and a weight of 1.8 kg to 4.5 kg. a) A cylindrical magnet (4) magnetized in the axial direction, b) A Halbach array type configuration having multiple magnets (4'), preferably eight magnets (4') arranged in a crown shape around a cylindrical central magnet (4), c) A Halbach array type configuration having four magnets (4') arranged around the central magnet (4) of a parallelepiped, i.e., along the side surface of the central magnet (4), d) A Halbach array type configuration having two magnets (4') positioned so as to be sandwiched along two sides of a central magnet (4) of a parallelepiped, and Selected from, In configuration b), the central magnet (4) is arranged in a state of axial polarization, while the crown-shaped plurality of magnets (4') have polarization arranged along a curve that converges toward the longitudinal axis of the central magnet (4). In configuration c), the central magnet (4) is arranged in a state where it is magnetized in the axial direction, while the four peripheral magnets (4') are magnetized parallel to a plane perpendicular to the magnetization direction of the central magnet (4). In configuration d), the central magnet (4) and the two sandwiched magnets (4') are arranged in a state where they are magnetized in directions of 90° relative to each other. The system (1) according to claim 1 or 2.

5. The magnetic source in configuration a) consists of a magnet (4) with dimensions of approximately D85-86 mm × Sp45-45.5 mm, and the total weight of the magnetic source is 2 kg. The magnetic source according to configuration b) consists of a central magnet (4) with a diameter of approximately 74 mm and a thickness of approximately 35 mm, and eight parallelepiped magnets (4') with dimensions of approximately Lc15 × Lu26 × Sp35 mm, the total weight of the magnetic source is approximately 2 kg, and the eight crown-shaped magnets (4') are spaced approximately 1 mm apart from the central magnet (4). The magnetic source according to configuration c) consists of a central magnet (4) with dimensions Lc = Lu 60-61 mm × Sp 35-44 mm and four peripheral magnets (4') with dimensions Lc 15-16 × Lu 60-61 × Sp 35-44 mm, and the total weight of the magnetic source is 2 to 2.5 kg. The magnetic source in configuration d) consists of a central magnet (4) with dimensions of approximately Lc44 × Lu45 × Sp58 mm and two sandwiched magnets (4') with dimensions of approximately Lc28-16 × Lu45 × Sp58 mm, and the total weight of the magnetic source is approximately 2 kg. Here, Lc is the short side, Lu is the long side, Sp is the thickness, and D is the diameter of the base of the cylindrical part (6). The system (1) according to claim 4.

6. The magnetic handpiece (2) includes a magnetic field concentration element (14) obtained using a ferromagnetic material shield, which is arranged in the form of multiple plates or as a continuous or discontinuous annular band, along the wall of the movable support element (6) or the body portion (5), optionally above the magnetic source, and which may consist of a single sheet of ferromagnetic material or multiple sheets arranged in contact or spaced apart. The system (1) according to claim 1 or 2.

7. The ferromagnetic material is a metal alloy containing 76-80% or about 80% nickel, about 14.5-15% iron, 3-6% or about 5% molybdenum, 4-55% copper, and trace amounts of silicon. The system (1) according to claim 6.

8. The casing (3) has a storage shell (15) positioned on a stand (16) including a base (16a) and a pole (16b), the base (16a) preferably having wheels (17), the storage shell (15) having a basket (18) and a lid (19) with a handle (21), the lid (19) being hinged to the basket (18) by two hinges (20) positioned at opposite points, the lid (19) and optionally the basket (18) being shaped like a spherical cap such that the storage shell (15) as a whole is substantially spherical or semi-oval. The system (1) according to claim 1 or 2.

9. The basket (18) has a toroidal body (23) which is preferably hollow inside to form a space (25), and the toroidal body (23) has a central seat (24) sized to accommodate the magnetic handpiece (2). The system (1) according to claim 8.

10. A catch (26) having an inclined bar (26a) hinged at its central point on a raised portion (27) positioned on the surface (18a) of the basket (18) is positioned on the outer surface (18a) of the basket (18) in close proximity to the upper edge (18b), and first and second retainer teeth (28a, 28b) are positioned in close proximity to the two ends of the inclined bar (26a), the first retainer tooth (28a) being configured to snap into a seat portion (29) recessed in the surface (18a) of the basket (18), while the second retainer tooth (28b) being configured to connect to a raised portion (30) positioned along the edge portion (19a) of the lid (19) at a central position relative to the hinge (20). The system (1) according to claim 8.

11. The basket (18) comprises a magnetic field shielding element (31) made of a ferromagnetic material plate, preferably a metal alloy containing 76-80% or about 80% nickel, about 14.5-15% iron, 3-6% or about 5% molybdenum, 4-55% copper, and trace amounts of silicon, wherein the total thickness of the magnetic field shielding element (31) is preferably 3 mm to 6 mm. The system (1) according to claim 9.

12. The magnetic field shielding element (31) comprises an annular sheet (31a) and a plurality of U-shaped sheets (31b) configured to also cover the bottom of the basket (18), and the magnetic field shielding element (31) is preferably housed in the inner space (25) of the toroidal body (23). The system (1) according to claim 11.

13. A magnetic handpiece (2) as defined in claim 1 or 2.

14. A casing (3) for a magnetic handpiece as defined in claim 8.

15. It is an endoscopy kit, A magnetic handpiece (2) defined in claim 1 or 2, An endoscope guide comprising a tubular guide element and an anchor head, wherein the tubular guide element has a longitudinal cavity, and the anchor head comprises an expandable container configured to contain a ferromagnetic material, A pre-filled syringe filled with a predetermined amount of aqueous suspension of ferromagnetic agent, or a glass vial filled with powdered ferromagnetic agent, preferably iron carbonyl, and a pre-filled syringe filled with physiological saline (an aqueous solution of NaCl and / or sodium citrate), or a glass vial filled with a suspension of ferromagnetic agent, preferably iron carbonyl, and an empty syringe. An endoscopy kit equipped with [specific features / equipment].

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