Magnetic handpiece for endoscope guide, in particular for colonoscope, and endoscopy system comprising said handpiece

Abstract

The invention relates to a magnetic handpiece of an endoscope guide, in particular suitable for colonoscopy. In particular, the invention relates to a magnetic handpiece system (1) comprising a magnetic handpiece (2) and a housing (3) wherein the magnetic handpiece (2) comprises a magnetic field source consisting of one or more permanent magnets, and wherein the magnetic handpiece (2) comprises a hollow body (5) having a longitudinal axis (X-X), a first end (5a) and a second end (5b), a movable support element (6) of a magnetic source is movably housed in the hollow body by a threaded coupling wherein the movable support element (6) is movable along an axis (X-X) between a raised or non-operative position and a plurality of lowered operative positions.

Description

Technical Field

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

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

[0003] Endoscopic guides (or "guidewires" in technical terms) are used in the art to position and act as guides, in particular for catheters, on which the guides are usually slidably mounted; in this respect, the catheters are 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 manipulation of the catheter and endoscope.

[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 interfering with the walls of the lumen itself, thereby maintaining the occlusion in place.

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

[0008] For example, such an anchoring head is difficult to use in certain areas of endoscopy, such as in the case of colonoscopy, 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 would lead to the need for even quite bulky balloons.

[0009] Furthermore, anchoring via a balloon is achieved by means of friction generated between the balloon and the surface of the organ mucosa. This can result in damage to the organ wall. In the case of colonoscopy, frictional obstruction leads to the need to increase the pressure on the wall of the viscera, thereby further stretching the balloon to obtain a more stable anchoring. However, this operation may result in excessive stretching of the viscera, with the risk of causing pain or even tissue tearing. Furthermore, sometimes, especially in the elderly or in certain pathological conditions, the viscera may be dilated or relaxed so that there is no resistance to balloon expansion. In this case, stretching the balloon may not only be risky, but also ineffective.

[0010] However, obtaining a firm and stable anchoring is necessary in order to ensure that the guide can also be operated for colonoscopy and endoscopy.

[0011] In particular, colonoscopy techniques require caution when introducing the colonoscope until the end of the colon, because the colon has a tortuous path and loose walls, thereby forming a loop that prevents the advancement of the colonoscope tip and the stretching of the colon wall, resulting in the occurrence of pain and the risk of visceral tearing. In these cases, the doctor must manipulate the instrument in an appropriate manner to correct the path as much as possible and continue to introduce the colonoscope until the end.

[0012] 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 same. 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 with the aid of a specific handpiece.

[0013] Although this system allows obtaining adequate anchoring to the colon wall without obstructing the lumen of the organ and without damaging its tissue, it has various drawbacks.

[0014] In particular, for the magnetic handpieces described here, they are the result of complex and costly manufacturing, have excessive weight, and are difficult to shield both during use and when the handpiece is stored. Inadequate shielding of the magnetic field has two disadvantages: it may cause interference with other devices placed nearby, and it may scatter the magnetic field in directions different from the preferred direction of interaction with the balloon filled with magnetic fluid. Therefore, the task of the present invention is to provide a magnetic handpiece system that solves one or more of the technical problems set out above with respect to the known magnetic handpieces.

[0015] In particular, the object of the present invention is to create a magnetic handpiece system that is faster and simpler to operate and has reduced size and weight, while being relatively cheap and simple to manufacture. Summary of the invention

[0016] The following other tasks and purposes are obvious, and one or more of the tasks and purposes set forth above are achieved by:

[0017] 1) A magnetic handpiece system comprising a magnetic handpiece and a housing, wherein the magnetic handpiece comprises a magnetic field source constituted by one or more permanent magnets, and wherein the magnetic handpiece comprises a hollow body having a longitudinal axis, a first end and a second end, a movable support element of the magnetic source being movably received in the hollow body by a threaded connection, wherein the movable support element is movable along the longitudinal axis between a raised or non-operating position and a plurality of lowered operating positions.

[0018] Other objects of the present invention are:

[0019] 2) A system as described in point 1), wherein the body comprises a closing element at the top, the closing element comprising a central sleeve portion with an axial opening, the shaft being inserted into the axial opening, 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 spiral shape, e.g. in a clockwise direction, to make the correct direction of rotation more intuitive to tighten and loosen the movable support element and thereby increase or decrease the applied magnetic attraction;

[0020] 3) A system as described in point 1) or 2), wherein the movable support element comprises a hollow cylindrical portion, the hollow cylindrical portion comprising an external thread and an inner surface comprising a plurality of ribs, the hollow cylindrical portion defining a hollow interior configured to accommodate the magnetic source; and wherein the body further comprises a thread on its inner surface, the thread being connectable to the thread of the movable support element;

[0021] 4) A system as described in any of the points 1) to 3), wherein the magnetization intensity of the magnetic source is equivalent to a disk-shaped permanent magnet with a magnetization intensity of N52 with a diameter between 70 and 90 mm, a thickness between 30 and 60 mm and a weight between 1.8 and 2.8 kg, and is selected from:

[0022] a) a magnet having a cylindrical shape with axial magnetization;

[0023] b) a HalBach array type configuration comprising a plurality of magnets (preferably eight magnets) arranged in a crown shape around a central magnet in the shape of a cylinder;

[0024] c) a HalBach array type configuration comprising four magnets arranged along the sides of a parallelepiped central magnet (ie relative to the periphery of said central magnet);

[0025] d) a HalBach array type configuration comprising two magnets sandwiched along two sides of a parallelepiped central magnet,

[0026] in:

[0027] - in configuration b), the central magnet is placed with an axial polarization, while the crown-shaped plurality of magnets have polarizations arranged along rays converging towards the longitudinal axis of the central magnet,

[0028] - in configuration c), the central magnet is placed with an axial magnetization, while the magnetizations of the four peripheral magnets are parallel to a plane perpendicular to the magnetization direction of the central magnet,

[0029] - in configuration d), the central magnet and the two sandwiching magnets are placed with magnetization along directions 90° to each other;

[0030] 5) A system as described in point 4), wherein:

[0031] - the magnetic source according to configuration a) consists of a magnet with dimensions of approximately D85-86 mm×Sp45-45.5 mm, wherein the total weight of the magnetic source is approximately 2 kg;

[0032] - a magnetic source according to configuration b) consisting of a central magnet with a diameter of approximately 74 mm and a thickness of approximately 35 mm and eight parallelepiped magnets with dimensions of approximately Lc15 x Lu26 x Sp35 mm, wherein the total weight of the magnetic source is approximately 2 kg and wherein the eight crown-shaped magnets are spaced approximately 1 mm from the central magnet;

[0033] - a magnetic source according to configuration c) consisting of a central magnet with dimensions of approximately Lc=Lu60-61 mm x Sp35-44 mm and four peripheral magnets with dimensions of approximately Lc15-16 x Lu60-61 x Sp35-44 mm, wherein the total weight of the magnetic source is between 2 and 2.5 kg;

[0034] - a magnetic source according to configuration d) consisting of a central magnet having dimensions of approximately Lc44 x Lu45 x Sp58 mm and two sandwiching magnets having dimensions of approximately Lc28-16 x Lu45 x Sp58 mm, wherein the total weight of the magnetic source is approximately 2 kg,

[0035] Where Lc = short side, Lu = long side, Sp = thickness, and D is the diameter of the base of the cylinder;

[0036] 6) The system according to any of the points 1) to 5), wherein the magnetic handpiece comprises a magnetic field concentrator element obtained using a ferromagnetic material shield, arranged along the wall of the body or the movable support element and optionally arranged above the magnetic source, in the form of a plurality of plates or as a continuous or discontinuous annular belt, and the magnetic field concentrator element can be composed of a single piece of ferromagnetic material or a plurality of pieces of ferromagnetic material placed in contact or spaced apart;

[0037] 7) A system as described in point 6), wherein the ferromagnetic material is a metal alloy comprising 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;

[0038] 8) A system as claimed in any of the points 1) to 7), wherein the housing comprises an enclosure placed on a support comprising a base and a rod, wherein the base preferably comprises wheels, the enclosure comprises a basket and a lid provided with a handle, the lid being hinged to the basket at two hinges placed at diametrically opposite points, and wherein the lid and optionally the basket are also shaped like a spherical cap, so that the enclosure as a whole is substantially spherical or semi-ovoid;

[0039] 9) A system as described in point 8), wherein the basket comprises an annular body, the annular body is preferably hollow inside to create a space, the annular body comprises a central seat sized to accommodate the magnetic handpiece;

[0040] 10) A system as described in point 8) or 9), wherein a latch member including a tilting rod is placed on the outer surface of the basket, located near the upper edge, the tilting rod is hinged at its midpoint on a ridge placed on the surface, and a first retainer tooth and a second retainer tooth are placed near the two ends of the rod, wherein the first retainer tooth is configured to snap-fit ​​into a seat recessed in the surface of the basket, and the second retainer tooth is configured to couple to a ridge placed along the edge of the lid, located at an intermediate position relative to the hinge;

[0041] 11) A system as described in any of points 8) to 10), wherein the basket includes a magnetic field shielding element, which is composed of a ferromagnetic material plate, preferably a metal alloy (including 76-80% or about 80% nickel, about 14.5-15% iron, 3-6% or about 5% molybdenum, 4-55% copper and trace silicon), and the total thickness of the shielding element is preferably between 3mm and 6mm;

[0042] 12) A system as described in point 11), wherein the shielding element comprises an annular sheet and a plurality of U-shaped sheets, which are configured to also cover the bottom of the basket, the shielding element being preferably accommodated in a space inside the annular body;

[0043] 13) A magnetic handpiece as defined in any one of points 1) to 7);

[0044] 14) A housing for a magnetic handpiece as defined in any one of points 8) to 12);

[0045] 15) An endoscopy kit comprising:

[0046] - a magnetic handpiece as defined in any one of points 1) to 7),

[0047] - an endoscopic guide comprising a tubular guide element and an anchoring head, wherein the tubular guide element comprises a longitudinal cavity and the anchoring head is provided with an expandable container configured to contain a ferromagnetic agent,

[0048] - a prefilled syringe filled with a pre-set amount of an aqueous suspension of a ferromagnetic agent; or a glass vial filled with a powdered ferromagnetic agent, preferably carbonyl iron, and a prefilled syringe filled with a saline solution (an 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.

[0049] The invention further relates to an endoscopy system, preferably for colonoscopy, comprising an endoscope guide cooperating with an external magnetic field source, wherein the magnetic field source is associated with a manually manipulable device, i.e. also without a moving device or auxiliary support, wherein the manually manipulable device is a magnetic handpiece, wherein the magnetic field source is movable between an operating position and a safe or rest position, wherein:

[0050] In the operating position, the magnetic field source is close to the operating end of the handpiece.

[0051] In the safe or resting position, the source of the magnetic field is directed away from the operative end of the handpiece.

[0052] Further features and advantages will become apparent from the description of a preferred but non-exclusive embodiment of the invention, shown by way of non-limiting examples. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Figure 1 is a side view of a magnetic handpiece according to the present invention;

[0054] Figure 2 is based on Figure 1 A cross-sectional view of the magnetic handpiece in the II direction;

[0055] Figure 3 yes Figure 1 A top view of a handle of a magnetic handpiece;

[0056] Figure 4 yes Figure 1 A bottom perspective view of a detail of a magnetic hand piece in FIG.

[0057] Figure 5A and Figure 5B depicts a perspective view and a plan view, respectively, of a first configuration of a magnet according to the present invention;

[0058] Fig. 6A and Figure 6Bdepicts a perspective view and a plan view, respectively, of a second configuration of a magnet according to the present invention;

[0059] Fig. 7A and Figure 7B depicts a perspective view and a plan view, respectively, of a third configuration of a magnet according to the present invention;

[0060] Fig. 9 is a graphical depiction of the lines of force of a magnetic field with and without side shielding;

[0061] Fig.10 yes Figure 1 A side view of a handpiece in FIG. 1 showing in transparency a system for concentrating a magnetic field;

[0062] Fig.11 yes Figure 1 A side view of a housing of a magnetic handpiece;

[0063] Fig.12 yes Fig.11 A cross-sectional side view of a housing in which a magnetic handpiece of the present invention is provided;

[0064] Fig.13 Shows Fig.11 A cutaway side view of a detail of the housing in FIG.

[0065] Fig.14 Shows Fig.13 A top cutaway view of the detail in;

[0066] Fig.15 Shows Fig.11 Perspective views of different details of the shell in;

[0067] Fig.16 Shows Fig.13 A perspective cutaway view of a detail of Figure 1 The magnetic handpiece in the

[0068] Fig.17 Shows Fig.11 Side views of different details of the housing;

[0069] Fig.18 A perspective view showing a variation of the housing of a magnetic handpiece. DETAILED DESCRIPTION

[0070] First, a description of how a diagnostic colonoscopy is performed will help to better understand the present invention.

[0071] A colonoscope is a flexible endoscope characterized by a tip (about 15 cm long), a body (about 130 cm long) and a manipulator. The tip is movable and houses an orifice for a camera, a light and an operating channel. The tip can be manipulated by moving a knob located on the manipulator. The body is flexible and, in some models, can also be selected to perform certain endoscopic maneuvers. Cables for transmitting images, a power supply and a tie rod for connecting the tip to the knob slide inside the body.

[0072] In addition to a knob for orienting the tip, the manipulator features external orifices for operating the channel and controls for aspirating or blowing air and recording images or video.

[0073] 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, known as the cecum. If the instrument does not reach the cecum, the doctor cannot determine whether there is any pathological change in the unexplored segment.

[0074] Positioning of the colonoscope is performed by an endoscope guide which is moved forward into the lumen of the colonoscope until it emerges from its distal end and is advanced as deeply as possible, then directing the path of the colonoscope. Similar techniques are performed to introduce other endoscopes, as well as to introduce catheters into the venous system.

[0075] The colon is a mobile hollow tubular organ with a loose wall. Unlike other hollow tubular organs (such as arteries, for example), the colon has a larger diameter, the wall can stretch several centimeters, and in some segments, the internal organs can move in the abdominal cavity, sometimes up to 30 cm.

[0076] This anatomical feature prevents the insertion of catheters or guides over segments of more than 10-30 cm. In fact, once inserted into the rectum via the anus, the catheter tends to curl 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 unless it is performed on a small segment. Even during radiological examinations, catheters or endoscope guides do not have sufficient terminal maneuverability or sufficient load-bearing strength. The load-bearing strength of an endoscope, catheter or endoscope guide refers to the ability to transmit 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 stiff cannot be easily manipulated along the curved path of the colon. Colonoscopes are designed to compromise between sufficient flexibility and sufficient load-bearing strength.

[0077] 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 is no longer able to transmit the thrust from the body to the tip, and the endoscopist is therefore unable to further advance the instrument and its camera. In these cases, the endoscopist's manual pushing of the instrument only results in the force being transmitted on the wall of the internal organs, causing pain and risk of trauma, without being able to advance the tip.

[0078] 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:

[0079] - 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;

[0080] - Advance the endoscope guide until it is 4-10 cm beyond the distal end of the colonoscope;

[0081] - introducing a magnetic or ferromagnetic agent into an expandable container of the endoscope guide so that the container reaches an expanded state;

[0082] - applying an external magnetic field by means of a magnetic field source in the abdominal area, where an expansion container with a magnetic or ferromagnetic agent is present, in order to attract the container to an anchoring point on the colon wall, wherein the holding force on the magnetic or ferromagnetic agent relative to the transverse pulling direction is at least equal to or greater than 5 Newtons;

[0083] - tensioning the endoscope guide by applying a pulling force of at least 5 Newtons by shaking dry at the proximal end of the endoscope guide;

[0084] -Advance the colonoscope until the anchor point of the vessel;

[0085] - Repeat the above steps until you reach the anchor point at the cecum.

[0086] Pulling on the endoscope guide is intended to keep the guide taut, thereby allowing the endoscope to slide more easily, and is intended to at least partially reduce the curvature of the colon loops, even in this case to facilitate the introduction of a relatively rigid endoscope.

[0087] As mentioned above, the endoscopy system described in EP3399901A1 highlights certain critical points that make its use unsuitable for diagnosis when performing the above method. The present invention therefore arises from the need to overcome these critical points.

[0088] An endoscopic inspection system in cooperation with the magnetic handpiece system according to the present invention includes an endoscopic guide, in particular an endoscopic guide for a colonoscope, the endoscopic guide including a tubular guide element and an anchoring head, wherein the tubular guide element includes a longitudinal cavity, the anchoring head is provided with an expandable container configured to accommodate a ferromagnetic agent, the expandable container is connected to the longitudinal cavity, and wherein the endoscopic inspection system further includes a ferromagnetic agent configured to be movable in the longitudinal cavity to fill / empty the expandable container.

[0089] The expandable container can be expanded and contracted manually, preferably in an elastic manner, so as to switch from a contracted state, in which the expandable container is essentially adhered to the body of the tubular guide element, to an expanded state, and vice versa, in which the expandable container protrudes outwardly from the body of the tubular guide element; filling or emptying the expandable container with the help of a ferromagnetic agent causes switching from the contracted position to the expanded position, and vice versa.

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

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

[0092] The ferromagnetic agent most suitable for the purposes of the present invention is an aqueous suspension of so-called carbonyl iron, although so-called ferrofluids or suspensions of magnetite or hematite may also be used.

[0093] Carbonyl iron is a high purity iron (97.5% for S grade and at least 99.5% for R grade) produced 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.

[0094] For the purposes of the present invention, carbonyl iron having the following particle size distribution is preferably used:

[0095] D10 = 3-4.5 microns, more preferably about 4.1 microns

[0096] D50 = 5-10 microns, more preferably about 9.5 microns

[0097] D90 = 4-30 microns, more preferably about 26 microns

[0098] The particle size of the ferromagnetic particles can be determined by known methods, for example:

[0099] - Direct observation by electron microscopy;

[0100] - Determination of aqueous suspensions by the "laser light scattering" method using a particle size laser analyzer (Malvern Mastersizer 3000) with LALLS (Low Angle Laser Light Scattering) technology using the Fraunhofer calculation theory.

[0101] The aqueous suspension of carbonyl iron according to the invention is preferably a suspension in purified water, wherein the carbonyl iron is present in a content by weight of between 45% and 60%, preferably between 50% and 55%, more preferably between 52% and 53%, relative to the total weight of the suspension. Preferably, the aqueous suspension further comprises sodium citrate in a content by weight of between 2.5% and 4.5% relative to the total weight of the suspension, and / or sodium chloride in a content by weight of between 5% and 8% relative to the total weight of the suspension.

[0102] Sodium citrate promotes the dispersion of carbonyl iron particles in the suspension.

[0103] Sodium chloride is used to inhibit bacterial growth.

[0104] The aqueous suspension of carbonyl iron is preferably degassed in order to avoid oxidation of the iron by oxygen absorbed in the water.

[0105] It has been noted that the use of the aqueous carbonyl iron suspension according to the invention has several advantages compared to known solutions, namely:

[0106] i) it has an increased magnetic response, thereby making it possible to reduce the amount of aqueous suspension used and, therefore, the filling volume of the expandable container 4;

[0107] ii) the spherical shape of the particles results in lower viscosity of the aqueous suspension and reduces the risk of formation of clusters and / or agglomerates;

[0108] iii) Carbonyl iron is widely available in the market with moderate cost and low toxicity, which is compatible with pharmaceutical use.

[0109] In particular, by virtue of these properties, and especially its increased magnetic response, the greatest synergy is achieved with the magnetic handpiece of the invention. In other words, the magnetic handpiece according to the invention provides its best performance in anchoring the head of the endoscope guide when the ferromagnetic agent is an aqueous suspension of carbonyl iron as defined above.

[0110] The magnetic handpiece system according to the invention will now be described, which is indicated as a whole by reference numeral 1 and comprises a magnetic handpiece 2 and a housing 3 .

[0111] The magnetic handpiece 2 includes a magnetic field source configured to exert a retaining force on the ferromagnetic agent relative to the lateral pulling direction, the retaining force being greater than 5 Newtons at a distance between 2 centimeters and 10 centimeters.

[0112] The term "exerting a retaining force on the ferromagnetic agent relative to a lateral pulling direction" refers to a retaining force on the ferromagnetic agent relative to a pull substantially perpendicular to the direction of maximum attractive force between the magnet and the ferromagnet, as determined by the lines of force of the magnetic field.

[0113] In order to allow sufficient pulling of the endoscope guide, the holding force of the expandable container against the colon wall relative to the lateral pulling direction is equal to or greater than 2 Newtons or equal to or greater than 5 Newtons as described above, which holding force depends on the amount of ferromagnetic agent in the container and the applied magnetic field, which in turn depends on the distance of the magnetic field source from the container filled with the ferromagnetic agent. Typically, in most colon segments, this distance is between 1 and 5 cm. However, this distance can be greater in obese patients, for example up to 10 cm.

[0114] The magnetic field source according to the invention consists of one or more permanent magnets. For the purposes of the invention, a magnetic field equal to that generated by a permanent magnet with a disk magnetization N52 (i.e. a magnet with a maximum magnetic energy per unit volume that can be stored in the magnet of 52 mega-gauss-oersted) with a diameter between 50 and 100 mm, a thickness between 30 and 80 mm and a weight between 1.8 and 4.5 kg can be used. It can be made of sintered neodymium, sintered ferrite, plastic neodymium, etc.

[0115] In particular, for example, the following magnetic source configuration may be used ( Figures 5A-8B ):

[0116] 1) A HalBach array type configuration comprising a plurality of magnets 4' (preferably 8 magnets 4' arranged in a crown shape) arranged in a crown shape around a cylindrical central magnet 4 ( Figure 5A and 5B );

[0117] 2) A HalBach array type configuration comprising four magnets 4' arranged along the side of a parallelepiped central magnet 4 (ie relative to the periphery of said central magnet 4) ( Fig. 6A and Figure 6B );

[0118] 3) A HalBach array type configuration comprising two magnets 4' sandwiched along two sides of a parallelepiped central magnet 4 ( Fig. 7A and Figure 7B );

[0119] 4) Cylindrical magnet 4 ( Fig. 8A and Figure 8B ).

[0120] Figure 5a Fig. 6A , Fig. 7A and Fig. 8A The direction of the magnetic field is also shown with the aid of arrows.

[0121] Specifically:

[0122] - in configuration 1), the central magnet 4 is placed with an axial polarization, while the crown-shaped plurality of magnets 4 ′ have polarizations arranged along rays converging towards the longitudinal axis of the central magnet 4 ;

[0123] - in configuration 2), the central magnet 4 is placed with an axial magnetization, while the magnetizations of the four peripheral magnets 4' are parallel to a plane perpendicular to the magnetization direction of the central magnet 4;

[0124] - In configuration 3), the central magnet 4 and the two sandwiching magnets 4 are placed with magnetization along directions at 90° to each other:

[0125] - In configuration 4), the magnet 4 has an axial magnetization.

[0126] In a preferred embodiment, the magnetic source according to configuration 1) consists of a central magnet 4 of approximately 74 mm in diameter and approximately 35 mm in thickness, and eight parallelepiped magnets 4' of approximately Lc15xLu26xSp35 mm dimensions (where Lc=short side; Lu=long side; Sp=thickness), wherein the total weight of the magnetic source is approximately 2 kg, and wherein the eight magnets 4' in the form of a crown are spaced approximately 1 mm from the central magnet 4. The latter feature allows the magnetic attraction force to be optimized with respect to the weight of the magnets.

[0127] In a preferred embodiment, the magnetic source according to configuration 2) consists of a central magnet 4 with dimensions L60-61 mm×Sp35-44 mm and four peripheral magnets 4' with dimensions Lc15-16×lu60-61×Sp35-44 mm, wherein the total weight of the magnetic source is between 2 and 2.5 kg.

[0128] In a preferred embodiment, the magnetic source according to configuration 3) consists of a central magnet 4 with dimensions of approximately lc44×Lu 45×sp 58 mm and two sandwiching magnets 4' with dimensions of approximately Lc28-16×Lu 45×sp 58 mm, wherein the total weight of the magnetic source is approximately 2 kg.

[0129] In a preferred embodiment, the magnetic source according to configuration 4) consists of a magnet 4 having dimensions of approximately D85-86 mm×Sp45-45.5 mm (where D is the diameter of the bottom of the cylinder), wherein the total weight of the magnetic source is approximately 2 kg.

[0130] 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:

[0131] A) increasing the applied magnetic field by gradually changing the distance of the external magnetic field source, or

[0132] B) An aliquot of a ferromagnetic reagent is gradually introduced into the expandable container 4, with an external magnetic field already applied.

[0133] The magnetic field source is contained in a handpiece that is particularly suitable for this application, which is the object of the present invention and will be described below.

[0134] like Figure 1-Figure 4 As shown, the magnetic handpiece 2 includes 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 a magnetic source is movably accommodated by a threaded connection, wherein the movable support element 6 can be moved along the axis XX between a raised or non-operating position and a plurality of lowered operating positions.

[0135] In other words, the movable support element 6 can be placed in an operating position adjacent to the second end 5b of the body 5 (where the maximum magnetic attraction is obtained on the supporting surface of the handpiece 2) or in multiple intermediate operating positions between the first end 5a and the second end 5b of the body 5.

[0136] The body 5 comprises a closure element 7 at the top, which comprises a central sleeve portion 7a having an axial opening 7b, into which a shaft 8 is inserted. The shaft 8 is connected to the movable support element 6 at an inner end 8a and to a handle 9 at an outer end 8b. In some embodiments, such as Figure 1 and Figure 3As shown, the handle 9 has a spiral shape, for example in a clockwise direction, to make the correct direction of rotation more intuitive in order to tighten and loosen the movable support element 6 and thus increase or decrease the applied magnetic attraction force.

[0137] As shown, the body 5 and the closing element 7 can be made in two separate parts, but they can also be made in one piece.

[0138] like Figure 4 As shown, the movable support element 6 comprises a hollow cylindrical portion 6a and a sleeve portion 6b in which the shaft 8 is accommodated and secured.

[0139] The hollow cylindrical portion 6a comprises an external thread 10, while the inner surface comprises a plurality of ribs 11, the function of which is to increase the contact surface with the magnet.

[0140] 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.

[0141] The body 5 in turn comprises on its inner surface a thread 13 which can be coupled to the thread 10 of the movable support element 6 .

[0142] Thus, by rotating the shaft 8 by means of the handle 9, the movable support element 6 can be tightened to or loosened from the internal thread 13 of the body 5, which causes the magnetic source to move closer to or away from (or vice versa, depending on the direction of the thread) the second end 5b of the body 5.

[0143] The shaft is provided with a graduated scale which indicates the intensity level of the selected magnetic field after the handle is turned. By giving the shaft a scale, it is easier to see and more convenient from a construction point of view. With the rotation of the handle 9, the height of the shaft decreases and therefore the magnet descends. This phenomenon makes the selected magnet level more obvious and therefore reduces the risk of possible errors in adjusting the magnetic field intensity.

[0144] The outer housing of the handpiece may be fully or partially transparent to facilitate viewing of the magnet or to facilitate inspection of the patient's skin on which the handpiece is placed. The latter may be advantageous for identifying possible transillumination phenomena.

[0145] Transillumination is when the light from the colonoscope is visible externally through the patient's skin. This phenomenon is a sign of a thin abdominal wall and also allows accurate identification of the position of the endoscope tip relative to the abdominal surface.

[0146] In some embodiments, the magnetic handpiece 2 includes a magnetic field concentrator element 14 (in Fig.10). The magnetic field concentrator element 14 is made of a ferromagnetic material shield, arranged above the magnetic source and along the wall of the body 5 or the movable support element 6, for example in the form of a plurality of plates or as a continuous or discontinuous annular band. In other embodiments, the magnetic field concentrator element 14 is placed only along the wall of the movable support element 6 or the body 5.

[0147] The magnetic field concentrator elements 14 may be embedded in the material of which the body 5 or the movable support element 6 is made, or they may be arranged along the surface of the body or the movable support element.

[0148] The magnetic field concentrator element 14 may be formed from a single piece of ferromagnetic material or multiple pieces of ferromagnetic material placed in contact or spaced apart.

[0149] Fig. 9 By way of example it is shown how the magnetic field concentrator element 14 (right side) distorts the magnetic field relative to the unshielded magnetic field (left side). It can be seen that the presence of the magnetic field concentrator element 14 allows to reduce the expansion of the field lines in the lateral direction and to concentrate them in the direction of operation of the magnetic handpiece 2. Thus, the magnetic attraction force towards the balloon filled with ferromagnetic material inserted in the organ to be analyzed is increased and thus the efficiency of the magnetic source is increased while reducing possible interference with nearby devices or objects.

[0150] The effectiveness of the shielding depends on the magnetic permeability of the material from which the magnetic field concentrator element 14 is made. A preferred material is a metal alloy comprising 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. Such alloys are marketed, for example, under the trade names Mumetal, Cryoperm, Vacoperm and Ultraperm.

[0151] The present invention further relates to a magnetic handpiece system 1 , comprising a magnetic handpiece 2 as described above and a housing 3 of the magnetic handpiece 2 .

[0152] The housing 3 is an important element as it must allow safe storage of the magnetic handpiece 2 when not in use as well as quick and easy removal and reinsertion during operating procedures.

[0153] like Figure 11-Figure 18 As shown, the housing 3 comprises a casing 15 placed on a support 16, which comprises a base 16a and a rod 16b. Fig.18 As shown, the base 16a may preferably include wheels 17 to allow an operator to easily move the housing 3.

[0154] The height of the bracket 16 is such that the handpiece 2 contained in the housing 3 can be easily grasped by any operator without requiring the operator to bend down significantly to pick it up. However, the height of the bracket 16 is minimized as much as possible to lower the center of gravity of the device and limit the risk of tipping over. In addition, if the bracket is low, the handpiece 2 is easily visible and graspable from any side.

[0155] The enclosure 15 is constituted by a basket 18 and a lid 19 hinged to the basket 18. Advantageously, the basket 18 and the lid 19 are shaped in the shape of a spherical cap, so that the enclosure 15 as a whole is substantially spherical. The lid 19 comprises two hinges 20 placed at diametrically opposite points. Thus, the opening and closing of the lid 19 can be achieved by moving the associated spherical cap onto the spherical cap of the basket 18 so that it can be easily operated with only one hand. This further allows to limit the overall dimensions of the lid once it is opened and avoids possible collisions that could cause the lid to close accidentally, compared to conventional lids with hinges at the ends. Conventional lids require space for their flipping if they are turned over. For example, if they are only opened by 90 degrees, the operator has limited access to the handpiece. In contrast, the spherical lid allows the handpiece to be grasped from any position. Finally, once opened, the spherical lid remains open by gravity and there is no risk of accidental closing if the bracket is bumped.

[0156] For this purpose, the lid 19 comprises a handle 21 which facilitates the movement of the lid (when it is released) and of the bracket (when it is closed and locked).

[0157] Furthermore, the cover is provided with a shield close to the inner surface. This shield is ferromagnetic and can attract magnets when the handpiece is removed. In order to limit this phenomenon, the cover of the invention is designed so that the lower surface of the cover always remains hidden and the upper surface is spaced 4-5 cm from the shield. This distance ensures that if a magnet approaches, the magnetic attraction becomes weaker and thus avoids the handpiece from accidentally hitting the cover. Such a hit could cause damage to the device or cause injury to the operator if his / her hand gets in the way. Furthermore, the shield in the housing is designed to be spaced 4-5 cm from the outer surface in order to limit the magnetic attraction between the handpiece and the shield.

[0158] In certain embodiments, basket 18 is semi-oval in shape and lid 19 is shaped like a spherical cap.

[0159] The basket 18 comprises at the bottom a sleeve 22 for connection with the rod 16b and has an annular body 23 which is preferably hollow inside so as to create a space 25. Thus, the structure can be made lighter.

[0160] The annular body 23 includes a central seat 24, such as Fig.12 and Fig.16 As shown, the central seat is dimensioned to accommodate the magnetic handpiece 2. The central seat 24 is conical in shape to facilitate repositioning and centering of the handpiece 2 and also to limit the risk of accidental knocking of the handpiece 2 during repositioning in the housing.

[0161] The central seat 24 allows the handpiece 2 to always remain vertical. This allows the following advantages.

[0162] The magnetic field on the sides of the handpiece is weaker and extends less in space. The operator holds the handpiece in a comfortable position to grip it and in the correct position for use during endoscopic surgery. The housing prevents the hand from approaching the body of the handpiece, which is the component containing the magnet and thus presents a risk of accidents where the hand is crushed. The housing thus facilitates the correct grip of the handpiece by the operator gripping the handle or the shaft alone.

[0163] A latch 26 comprising an inclined rod 26a, which is hinged at its midpoint on a ridge 27 placed on the surface 18a, is placed on the outer surface 18a of the basket 18, in a position close to the upper edge 18b. A first retainer tooth 28a and a second retainer tooth 28b are placed close to the two ends of the rod 26a. The first retainer tooth 28a is configured to snap-fit ​​into a seat 29 recessed in the surface 18a of the basket 18, while the second retainer tooth 28b is configured to couple to a ridge 30 placed along the edge 19a of the lid 19, in an intermediate position relative to the hinge 20. The latch 26 is designed to be operated by one hand, so as to obtain two stop positions: one corresponding to the open position of the lid 19, so that the latch 26 does not hinder its opening; and the other corresponding to the closed position, keeping the lid 19 closed on the basket 18.

[0164] In a preferred embodiment, if Fig.16 As shown, the basket 18 includes a magnetic field shielding element 31. When the magnetic handpiece 2 is stored in the housing 3, the shielding element 31 prevents (or at least reduces the risk of) its magnetic field from expanding outwardly and thereby being able to interfere with externally located equipment.

[0165] The shielding element 31 is made of a plate of ferromagnetic material, preferably the above-mentioned metal alloy (comprising 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).

[0166] In certain embodiments, the shielding element 31 includes an annular sheet 31 a and a plurality of U-shaped sheets 31 b configured to also cover the bottom of the basket 18 .

[0167] The cover 19 has a sufficiently extended overall surface to accommodate the shielding element 31 and to ensure a spacing of at least 4-5 cm not only from the upper surface but also from the edges.

[0168] To ensure that the cover 19 can be fully opened and the entire center seat 24 of the handpiece 2 is accessible from all directions, the cover 19 is recessed at its rear portion (the portion opposite the latch 26) so that the axis of the housing does not hinder the full opening of the cover 19.

[0169] The shielding element 31 is preferably accommodated in the space 25 inside the annular body 23 .

[0170] The silicone pad for limiting the impact of the handpiece when the handpiece 2 is stationary or when the housing moves is located on the bottom of the handpiece housing. This pad is only placed on the bottom so that it is easy to remove and clean.

[0171] The total thickness of the shielding element 31 is preferably between 3 mm and 6 mm.

[0172] The conical shape of the central seat 24 thus also facilitates the centering of the handpiece 2 relative to the outer surface of the bracket and the shielding of the housing. Thus, the extension of the magnetic field to the external environment can be limited.

[0173] The invention further relates to an endoscopy kit comprising a magnetic handpiece 2 according to the invention, an endoscope guide as described in EP3399901A1, a pre-filled syringe filled with a preset amount of an aqueous suspension of a ferromagnetic agent, and optionally a catheter.

[0174] In certain embodiments of the kit of the invention, the syringe is prefilled with a suspension of said ferromagnetic agent, preferably in a volume of between 20 and 30 ml, more preferably about 25 ml, and wherein said ferromagnetic agent is carbonyl iron.

[0175] In an alternative embodiment, a kit according to the invention comprises:

[0176] - a glass vial filled with a powdered ferromagnetic reagent (preferably carbonyl iron) and a pre-filled syringe filled with a saline solution (NaCl and / or aqueous sodium citrate solution), or

[0177] - Glass vial with a suspension of a ferromagnetic reagent (preferably carbonyl iron) and an empty syringe.

[0178] 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 EP 3 399 901 A1 , which is another object of the present invention.

[0179] Essentially, it has been discovered how the present invention achieves the preset tasks and aims, since it allows providing a magnetic handpiece 2 that allows obtaining a strong anchoring, mainly as a result of the synergistic effect obtained by means of a considerable amount of a ferromagnetic agent that can be introduced into the expandable container of the endoscope guide and the enhanced magnetic field that can be applied from the outside by said magnetic handpiece 2. Said synergistic effect is particularly pronounced when the ferromagnetic agent is carbonyl iron.

[0180] The magnetic handpiece system 1 according to the invention is also easy to manufacture and affordable, and is quick and safe to use. In particular, the housing 3 can be opened and closed with only one hand, leaving the operator's other hand free. The attractive force of the magnetic handpiece 2 is easily adjusted by rotating the handle 9 in a clockwise or counterclockwise direction, thereby bringing the magnetic field source closer to or farther away (or vice versa, depending on the direction of the thread) from the surface of the patient's abdomen, respectively. The shielding of the housing and the magnetic field concentrator element of the magnetic handpiece allow reducing magnetic interactions with objects or devices in directions other than the direction of use.

[0181] Obviously, only some particular embodiments of the invention have been described and a person skilled in the art will be able to make all the changes necessary to adapt it to a particular application without departing from the scope of protection of the invention.

[0182] In practice, the materials used (as long as they are compatible with the specific use as well as the possible dimensions and shapes) may vary according to the requirements and progress of the art.

Claims

1. A magnetic handpiece system (1), comprising a magnetic handpiece (2) and a housing (3), wherein: The magnetic handpiece (2) comprises a magnetic field source constituted by one or more permanent magnets, and wherein the magnetic handpiece (2) comprises a hollow body (5) having a longitudinal axis (XX), a first end (5a) and a second end (5b), a movable support element (6) of the magnetic source being movably accommodated in the hollow body by a threaded connection, wherein the movable support element (6) is movable along the axis (XX) between a raised or non-operating position and a plurality of lowered operating positions.

2. The system (1) according to claim 1, wherein: The body (5) comprises a closing element (7) at the top, the closing element comprising a central sleeve portion (7a) having an axial opening (7b), a shaft (8) being inserted into the axial opening, the inner end (8a) of the shaft (8) being connected to the movable support element (6), and the outer end (8b) of the shaft (8) being connected to a handle (9), the handle (9) preferably having a spiral shape, for example in a clockwise direction, to make the correct rotation direction more intuitive in order to tighten and loosen the movable support element (6) and thereby increase or decrease the applied magnetic attraction.

3. The system (1) according to claim 1 or 2, wherein: The movable support element (6) includes a hollow cylindrical portion (6a), which includes an external thread (10) and an inner surface including a plurality of ribs (11), and the hollow cylindrical portion (6a) defines a hollow interior (12) configured to accommodate the magnetic source; and wherein the main body (5) includes a thread (13) on its inner surface, which can be connected to the thread (10) of the movable support element (6).

4. The system (1) according to any one of claims 1 to 3, wherein: The magnetic source has a magnetization equivalent to a disk-shaped permanent magnet with a magnetization of N52 having a diameter between 50 and 100 mm, a thickness between 30 and 80 mm and a weight between 1.8 and 4.5 kg, and is chosen from: a) a magnet (4) having a cylindrical shape and axial magnetization; b) a HalBach array type configuration comprising a plurality of magnets (4'), preferably eight magnets (4'), arranged in a crown shape around a central magnet (4) in the shape of a cylinder; c) a HalBach array type configuration comprising four magnets (4') arranged along the sides of a parallelepiped central magnet (4), ie arranged relative to the periphery of said central magnet (4); d) a HalBach array type configuration comprising two magnets (4') sandwiched along two sides of a parallelepiped central magnet (4), in: - in configuration b), the central magnet (4) is placed with an axial polarization, while the crown-shaped magnets (4') have polarizations arranged along rays converging towards the longitudinal axis of the central magnet (4), - in configuration c), the central magnet (4) is placed with an axial magnetization, while the magnetizations of the four peripheral magnets (4') are parallel to a plane perpendicular to the magnetization direction of the central magnet (4), - In configuration d), the central magnet (4) and the two sandwiching magnets (4') are placed with their magnetization along directions at 90° to each other.

5. The system (1) according to claim 4, wherein: - the magnetic source according to configuration a) consists of a magnet (4) with dimensions of approximately D85-86 mm×Sp45-45.5 mm, wherein the total weight of the magnetic source is approximately 2 kg; - a magnetic source according to configuration b) consisting 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 x Lu26 x Sp35 mm, wherein the total weight of the magnetic source is approximately 2 kg and wherein the eight crown-shaped magnets (4') are spaced approximately 1 mm from the central magnet (4); - a magnetic source according to configuration c) consisting of a central magnet (4) with dimensions approximately Lc=Lu60-61 mm x Sp35-44 mm and four peripheral magnets (4') with dimensions approximately Lc15-16 x Lu60-61 x Sp35-44 mm, wherein the total weight of the magnetic source is between 2 and 2.5 kg; - a magnetic source according to configuration d) consisting of a central magnet (4) with dimensions of approximately Lc44 x Lu45 x Sp58 mm and two sandwiching magnets (4') with dimensions of approximately Lc28-16 x Lu45 x Sp58 mm, wherein the total weight of the magnetic source is approximately 2 kg, Where Lc = short side, Lu = long side, Sp = thickness, and D is the diameter of the base of the column (6).

6. The system (1) according to any one of claims 1 to 5, wherein: The magnetic handpiece (2) comprises a magnetic field concentrator element (14), which is obtained using a ferromagnetic material shield, arranged along the wall of the body (5) or the movable support element (6) and optionally arranged above the magnetic source, in the form of multiple plates or as a continuous or discontinuous annular belt, and the magnetic field concentrator element can be composed of a single piece of ferromagnetic material or multiple pieces of ferromagnetic material placed in contact or at intervals.

7. The system (1) according to claim 6, wherein: The ferromagnetic material is a metal alloy that includes 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.

8. The system (1) according to any one of claims 1 to 7, wherein: The housing (3) comprises a casing (15) placed on a support (16), the support comprising a base (16a) and a rod (16b), wherein the base (16a) preferably comprises wheels (17), the casing (15) comprising a basket (18) and a cover (19) provided with a handle (21), the cover (19) being hinged to the basket (18) at two hinges (20) placed at diametrically opposite points, and wherein the cover (19) and optionally the basket (18) are also shaped in the shape of a spherical cap, so that the casing (15) as a whole is essentially spherical or semi-oval.

9. The system (1) according to claim 8, wherein: The basket (18) comprises an annular body (23) which is preferably hollow inside to create a space (25), the annular body (23) comprising a central seat (24) sized to accommodate the magnetic handpiece (2).

10. The system (1) according to claim 8 or 9, wherein: A latch member (26) comprising a tilting rod (26a) is placed on the outer surface (18a) of the basket (18) at a position close to the upper edge (18b), the tilting rod being hinged at its midpoint on a ridge (27) placed on the surface (18a), a first retainer tooth (28a) and a second retainer tooth (28b) being placed close to the two ends of the rod (26a), wherein the first retainer tooth (28a) is configured to be snap-fittedly coupled in a seat (29) recessed in the surface (18a) of the basket (18), and the second retainer tooth (28b) is configured to be coupled to a ridge (30) placed along the edge (19a) of the lid (19) and located in a mid-position relative to the hinge (20).

11. The system (1) according to any one of claims 8 to 10, wherein: The basket (18) comprises a magnetic field shielding element (31), which is composed of a ferromagnetic material plate, preferably a metal alloy, which includes 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, and the total thickness of the shielding element (31) is preferably between 3mm and 6mm.

12. The system (1) according to claim 11, wherein: The shielding element (31) includes an annular sheet (31a) and a plurality of U-shaped sheets (31b), which are configured to also cover the bottom of the basket (18), and the shielding element (31) is preferably accommodated in a space (25) inside the annular body (23).

13. A magnetic handpiece (2) according to any one of claims 1 to 7.

14. A housing (3) for a magnetic handpiece according to any one of claims 8 to 12.

15. An endoscopy kit comprising: - A magnetic handpiece (2) according to any one of claims 1 to 7, - an endoscopic guide comprising a tubular guide element comprising a longitudinal cavity and an anchoring head provided with an expandable container configured to contain a ferromagnetic agent, - a prefilled syringe filled with a preset amount of an aqueous suspension of a ferromagnetic agent; or a glass bottle filled with a powdered ferromagnetic agent, preferably carbonyl iron, and a prefilled syringe filled with saline (an aqueous solution of NaCl and / or sodium citrate); or a glass bottle with a suspension of a ferromagnetic agent, preferably carbonyl iron, and an empty syringe.

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