Title of Invention	A DIAGNOSTIC DEVICE
Abstract	A diagnostic device (10) for pathologies of tubular anatomical structures comprises a tubular elongated structure (12, 28) developing between a proximal end and a distal end and is suitable to be inserted in the tubular anatomical structure, means (22, 32) for locally dilating the walls of the tubular anatomical structure that are associated with the distal end of said elongated structure, said means for locally dilating being movable between a closed position for introducing the device and at least one open position for viewing and evaluating the pathology, and control means being associated with the proximal end of the elongated structure, said control means being operatively connected to said means for locally dilating, in order to move them between the closed position and the open position, and vice versa.

Title of Invention

A DIAGNOSTIC DEVICE

Abstract

A diagnostic device (10) for pathologies of tubular anatomical structures comprises a tubular elongated structure (12, 28) developing between a proximal end and a distal end and is suitable to be inserted in the tubular anatomical structure, means (22, 32) for locally dilating the walls of the tubular anatomical structure that are associated with the distal end of said elongated structure, said means for locally dilating being movable between a closed position for introducing the device and at least one open position for viewing and evaluating the pathology, and control means being associated with the proximal end of the elongated structure, said control means being operatively connected to said means for locally dilating, in order to move them between the closed position and the open position, and vice versa.

Full Text	1 "A diagnostic device" DESCRIPTION A diagnostic device for the pathologies of tubular anatomical structures, such as for example the 5 intestinal tracts, is the object of the present invention. In particular, the present invention relates to a diagnostic device for pathologies of the colon or the rectum such as for example intussusception, stenosis, prolapse, rectocele. 10 The need for the availability of a diagnostic device for the aforementioned pathologies, which can be manufactured with limited expense, usable even in non hospital or clinical structures and which gives rise to the least possible discomfort in patients, avoiding for 15 example the administration of sedatives, is particularly felt within the field. Furthermore, the need for the availability of a diagnostic device which allows the verification of the presence and the extent of a mucosal prolapse is particularly felt. 20 Diagnostic devices, such as flexible colonoscopes and sigmoidoscopes which have significant drawbacks are known. Generally, colonoscopes work by the insufflation of air in order to dilate the walls of the intestinal tract subjected to analyses. The insufflation of air 25 gives rise to significant discomfort in the patients and 2 frequently it is necessary to resort to the administration of sedatives. Furthermore, the insufflation of air causes dilation of the rectum with the consequence that any possible mucosal prolapse 5 disappears and may not be viewed. Anoscopes which allow the direct vision of the area involved and which can also be of large dimensions, for example with diameters greater than 2 cm, are also known, causing pain during insertion and requiring the 10 relaxation of the sphincter. Due to the complexity and the expense of the equipment required, in addition to the high discomfort which they cause in patients, frequently the only structures which are so equipped are hospitals or 15 clinics, requiring therefore that the majority of the diagnostic procedures be carried out in such environments. The problem at the heart of the present invention is that of providing a diagnostic device for the 20 pathologies of the intestinal tracts, in particular of the rectum and colon, which has structural and operational characteristics such as to satisfy the aforementioned needs and to overcome the aforementioned drawbacks cited in reference to the known art. 25 Such a problem is solved by a diagnostic device in 3 accordance with claim 1. The dependent claims refer to further embodiments of the device according to the present invention. Further characteristics and advantages of the 5 diagnostic device according to the invention will arise from the following reported description of its preferred exemplary embodiments, which are given as non-limiting indication, with reference to the attached figures, wherein: 10 Figure 1 is an exploded, perspective view of a possible embodiment of the diagnostic device according to the present invention; Figure 2 shows a side view of the diagnostic device from figure 1, where several details have been omitted 15 in order to enhance other ones; Figure 3 shows the diagnostic device from Figure 2 in a different operating condition; Figure 4 shows a perspective view of a detail of the distal end of a diagnostic device according to the 20 present invention, in accordance with a possible embodiment and in a first operating condition; Figure 5 shows a perspective view of the detail from Figure 4 in a second operating condition; Figure 6 illustrates an exploded, perspective view 25 of two components of the detail from Figure 4 or 5; 4 Figure 7 is a partially exploded, perspective view of a possible embodiment of the diagnostic device according to the present invention; Figure 8 shows a perspective view of a detail of 5 the diagnostic device from Figure 7, when assembled, where several details have been omitted in order to enhance other ones; Figure 9 is a partially exploded, perspective view of a possible embodiment of the diagnostic device 10 according to the present invention; The present invention generally relates to a diagnostic device for pathologies of tubular anatomical structures, such as the intestinal tracts for example of the rectum and colon. In general terms the device 15 advantageously comprises an elongated structure which develops between a proximal end and a distal end and which is suitable for being inserted within the anatomic structure to be examined. Means for locally dilating the walls of the tubular structure associated with the 20 distal end of the elongated structure are further provided. The means for dilating are movable between a closed position for the introduction of the device and at least one open position for the viewing and the evaluation of the pathology. 25 The means for locally dilating are operatively 5 connected with control means associated with the proximal end of the elongated structure. These control means are actuated by the operator in order to open or close the dilating means. 5 In addition, viewing means suitable for being associated with the elongated structure and for reaching the tract dilated by the means of dilating are provided. In general terms, which can be applied to any embodiment of the device according to the present 10 invention, by proximal is conventionally meant either a portion or end of the device which, whilst in use, is near to the operator holding the device and carrying out the examination, whereas by distal is conventionally meant either a portion or end of the device which, 15 whilst in use, is remote with respect to the operator carrying out the examination. Furthermore, by the term advancement is meant a movement, preferably translation, carried out in the direction from the proximal end towards the distal end (for example along the arrow F of 20 Figure 3) , whereas by withdrawal is meant a movement, preferably translation, carried out in the direction from the distal end towards the proximal end (for example along the arrow F' of Figure 2). Some embodiments of such a device will be described 25 below, for example with reference to the annexed 6 figures. With reference to the Figures 1-3, by 10 has been generally indicated a trans-anal diagnostic device according to a first embodiment. The elements in common 5 throughout the illustrated embodiments will be described and designated with the same numeral. With 12 has been designated an inner tube preferably of a cylindrical shape and hollow inside. The inner tube 12 may be for example in semi-rigid or 10 flexible material, for example in plastic material. The inner tube 12 extends between a proximal end 12a and a distal end 12b. The proximal end 12a is operatively associated with a grip member 14, for example in the shape of a handle. More in particular, 15 the inner tube is partially housed within a cylindrical cavity 15 of the grip member 14 and is free to slide therein along its longitudinal axis. According to a possible embodiment, two slots 16 are formed in portions that are diametrically opposed to 20 the inner tube 12 and near the proximal end 12a. More in particular, the slot 16 extends in the circumferential direction relative to the inner tube 12. Preferably both slots pass through the entire thickness of the inner tube 12. 25 The distal end 12b of the inner tube is operatively 7 linked to arms or petals 22 preferably extending in the longitudinal direction relative to the inner tube 12. Advantageously, the arms 22 are formed as one piece with the inner tube 12. A possible embodiment of the arms 22 5 will be described below with reference to Figures 4-6. Figures 4-6, in fact, show an enlarged detail of the distal end of the diagnostic device. In accordance with a possible embodiment, an arm 22 of the inner tube 12 comprises a hook 24 extending out 10 of the arm, in a substantially radial direction. More in detail, the hook 24 has an L-configuration extending from one side of arm 22 and runs down the arm in a crosswise manner. In other words, the hook 24 defines a seat being laterally opened on arm 22. Yet in other 15 words, the hook 24 comprises a first tract 24a extending from the arm 22 perpendicular thereto and towards the exterior of the arm, and a second tract 24b extending perpendicular to the first one crosswise to the longitudinal development of the arm 22. Preferably, the 20 length of second tract as measured along the longitudinal direction of arm 22 is greater than that of the first tract. Furthermore, the second tract preferably extends along a width, as measured crosswise to the longitudinal direction of the arm, which is equal 25 to about the width of the arm. 8 In accordance with a possible embodiment, the free end 22a of the arms has an enlargement 26 such as to have a greater thickness than the remaining portion of the arm. Advantageously, the enlargement 26 is arranged 5 at the hook 24. The arms 22 are suitable to assume at least two extreme configurations corresponding to a closed configuration (Figure 5) and completely open configuration (Figure 4) . In the closed configuration, 10 the free ends of the arms 22 are in contact to each other and the tip or distal end of the diagnostic device is substantially olive-shaped. In the open configuration, the arms 22 mutually detach and assume a configuration which is substantially cup-shaped. 15 In accordance with a possible embodiment, at least one of the arms 22 has detection elements or markers 27 therein, which are preferably numerated along the longitudinal direction of the arm in order to evaluate the extent of the pathology encountered. 20 With reference to the embodiment illustrated in Figures 1-3, an outer tube has been overall designated with 28. In the assembled configuration of the device 10, the outer tube 28 houses the inner tube 12 therein. With reference also to the outer tube 28 a proximal end 25 designated with 28a and a distal end designated with 28b 9 can be identified. According to a possible embodiment, the outer tube 28 can be made of semi-rigid or flexible material, for example of plastic material. According to a possible embodiment, the outer tube 5 28 may have one or more detection elements or markers 30, for example distributed along the length of the outer tube itself, in order to measure the length of penetration of the device inside the anus and accordingly the location of the pathology encountered. 10 According to one possible embodiment the markers 30 have the shape of circular rings that are arranged transversal to the tube, which are preferably numerated and distributed along the length of the outer tube. In accordance with a possible embodiment, the 15 proximal end 28a of the outer tube has an annular rib 29. In accordance with a further embodiment, the proximal end 28a of the outer tube has at least one hole 31, preferably two holes that are arranged diametrically opposed on the outer tube and preferably passing through 20 the thickness of the outer tube. In the event that both the annular rib 29 and the holes 31 are advantageously provided, the latter are formed at the annular rib. Advantageously, the outer tube 28 is shorter than the inner tube 12 such that a portion of the inner tube 25 starting from the proximal end of the inner tube 10 projects from the proximal end of the outer tube, for example within the cylindrical cavity 15 of the grip member 14. In accordance with a possible embodiment, the outer 5 tube and the inner tube are partially housed within the grip member 14, more precisely within the cylindrical cavity 15. The distal end 28b of the outer tube is operatively linked to arms or petals 32 preferably extending in the 10 longitudinal direction relative to the outer tube 28. Advantageously, the arms 32 are formed as one piece with the outer tube 28. Figures 4-6 show in detail a possible embodiment of the arms 32 of the outer tube. To each arm 22 of the inner tube 12 there 15 corresponds an arm 32 of the outer tube 28, and in the assembled configuration of the device 10, the two associated arms overlap. In accordance with a possible embodiment, the arms 22 of the inner tube 12 and the arms 32 of the outer 20 tube 28 have such a configuration suitable to mutual coupling, particularly by means of a shape-coupling that allows to control the opening and closure of the arms 32 of the outer tube 28 by opening and closing the arms 22 of the inner tube 12. 25 With reference to Figures 4-6 and particularly 11 Figure 6, each arm 32 has a seat 34 on the side thereof which is suitable to receive a portion of the hook 24 and particularly the first tract 24a. Furthermore, the distal end of the arms 32 has a step 36 suitable to abut 5 against the hook 24, and particularly against the second tract 24b. The mutual assembly of the arms 22 of the inner tube 12 and the arms 32 of the outer tube 28 provides that one tube is inserted inside the other such that the 10 respective arms are slightly angularly offset. A slight mutual rotation of the two tubes will bring each arm 32 of the outer tube into the seat being defined by the respective hook 24. The seat 34 houses the first tract 24a whereas the second tract 24b abuts against the step 15 36. Preferably, the thickness of step 36 decreases towards the free end of the arm 32. The arms 32 of the outer tube 28 are suitable for assuming at least two extreme configurations 20 corresponding to a closed configuration (Figure 5) and a completely open configuration (Figure 4). In the closed configuration, the free ends of the arms 32 are in contact to each other and the tip or distal end of the diagnostic device is substantially olive-shaped. In the 25 open configuration, the arms 32 mutually detach and 12 assume a configuration which is substantially cup- shaped. The passage between the two open/closed extreme positions of the distal end of the device is carried out 5 by means of a relative translation of the inner tube 12 and the outer tube 28. Advantageously, the arms 32 of the outer tube 28 are idle and controlled by the arms 22 of the inner tube both for opening and closing. Considering the stationary outer tube and the 10 moving inner tube, by making the inner tube advance along the arrow F one passes from the closed configuration (Figure 5) to the open configuration (Figure 4) . In fact, both the first tract 24a and the second tract 24b push each arm 32 of the outer tube to a 15 radially wider position. On the contrary, a backward movement of the inner tube along the arrow F' causes the arms 22 of the inner tube and 32 of the outer tube to shift from the open configuration (Figure 4) to the closed configuration (Figure 5) . In fact, the first 20 tract 24a of the hook 24 cooperates with the arm 32 of the outer tube 28, within the seat 34, whereas the second tract 24b cooperates with the outer surface of the arm 32 by dragging each corresponding arm 32 of the outer tube 28 to closure. 25 According to a possible embodiment, a membrane 38 13 preferably made from plastic or foldable material is fit on the distal end of the outer tube 28, i.e. on the arms 32. According to a possible embodiment, the membrane is made from transparent material. 5 Figures 1-3 show a possible embodiment of the means for actuating a relative translation movement between the inner tube 12 and the outer tube 28. Specifically, these means are suitable for translating the inner tube 12 relative to the stationary outer tube 28, but it may 10 also be provided otherwise. The grip member 14 has an elongated opening 49 allowing the connection between the inner tube 12 and a control slide 42. Preferably, the control slide is fork- shaped in order to be connected to the inner tube at 15 portions diametrically opposed thereon. Particularly, the contxol slide 42 has ends that are suitable to be inserted in the slots 16 of the inner tube, from the outside of the inner tube. In the case where the control slide is fork-shaped, the ends of the 20 prongs comprise relative pins 44 which are suitable to be inserted into the slots 16. A control member 46 is operatively associated with the control slide 42 to generate a forward and backward motion of the inner tube within the outer tube. 25 Advantageously, the control member 4 6 is configured 14 as a lever with an end connected to the grip member 14 by means of a pin 48. The connection between the control member 46 and the control slide 42 is provided by a further pin 50 that is mounted on the control member 46 5 in an intermediate area between the pin 40 and the free end of the control member 46. In accordance with a possible embodiment, the grip member 14 comprises a ring 52 to receive the thumb of the operator's hand. 10 According to an advantageous embodiment, besides to what has been described above, there is provided a guide profile 54 which is housed in a longitudinal groove 56 of the grip member 14. The pins 44 also extend outside the inner tube for being inserted into the guide profile 15 54. In accordance with a possible embodiment, the cylindrical cavity 15 of the grip member 14 is counter- shaped relative to the annular rib 29 of the outer tube such as to prevent that the outer tube may translate 20 within the grip member 14. Furthermore, the cylindrical cavity 15 may have pins 58 suitable to be inserted in the holes 31, if provided, of the outer tube in order to prevent that the outer tube may rotate within the grip member 14. 25 With reference to the embodiment illustrated in 15 Figures 1-3, the operator holds the grip member 14, by passing his thumb through the ring 52, if present, and gripping the control member 46. From the open position from Figure 1 or 3, the 5 operator rotates the control member 46 by closing the same towards the grip member body. The control slide 42 pushes the inner tube 12 backwards thereby closing the arms of the inner tube and the outer tube such as described above. The pins 44 are free to slide along the 10 slots 16 in the circumferential direction relative to the tube. The cylindrical cavity 15 has such an extension allowing a translation movement of the inner tube that is sufficient for the arms to shift between the two extreme open/closed positions. 15 With reference to the definition of the device according to the present invention, the inner tube and the outer tube define the elongated structure developing between a proximal end and a distal end. The length of the elongated structure may be changed. As a function of 20 the material with which the inner tube and the outer tube are made, the elongated structure can be either semi-rigid or flexible. The arms 22 of the device 10 define means for locally dilating the walls of the anatomical structure of interest, which are associated 25 with the distal end of the elongated structure. The 16 control means comprise the inner tube and the outer tube which can slide one inside the other and the means which cause this relative translation. The device 10 in the closed position is introduced 5 transanally into the rectum/colon sigmoid/colon of the patient by the physician or the operator carrying out the examination. The degree of introduction of the device 10 can be verified using the markers 30 on the outer tube 28, if present. The insertion of the device 10 10 is facilitated by the olive-shape of the distal tip of the device, i.e. of the arms 22 and 32. When the desired position has been reached, the distal end of the device is opened "flower-like" such as to gradually widen the area of interest, as will be 15 described below with reference to the embodiment in question. The operations described above for opening the distal end of the device 10, in which a translation of the inner tube 12 is provided to be generated relative 20 to the grip member 14 and outer tube 28, can be similarly carried out by generating a translation of the outer tube relative to the inner tube and grip member. The device 10 described above may be used in association with viewing equipment (for example 25 laparoscopes 60) which are introduced into the inner 17 tube 12 and which, thanks to the opening of the arms 22, can be directed towards the appropriately widened area of interest such that the operator (physician) can check for the presence and the extent of the various 5 pathologies. In other words the inner tube 12 allows the passage of illuminating and optical elements for the viewing of the area of interest. Alternatively, the device 10 can be associated with an apparatus provided with a colon-scope and 10 insufflation device available from specialist medical practitioners. By gradually and selectively widening the distal end of the device 10, for example, one can check the response of the mucosa by mimicking defecation. 15 The present device allows the diagnosis of various pathologies among which intussusception, stenosis, prolapse, rectocele. The location of the defect can be quantified by means of the markers arranged on the outer tube. The extent of the defect can be quantified as a 20 function of the location to which the mucosa falls along the markers on the arms. The device 10 can additionally be moved backwards or forwards while opening and closing the same in order to allow the analyses of the various sections of tissues 25 and in order to diagnose the conditions of the prolapse. 18 From what has been stated above, one can appreciate how providing a diagnostic device according to the present invention allows to have available a low cost device useful in the diagnosis of pathologies of tubular 5 anatomical structures such as colon-rectal tracts. For example it is possible to identify and evaluate pathologies like intestinal blockages, intussusception, stenosis, prolapse and rectocele. Being capable of carrying out the diagnosis and 10 quantification of a rectal prolapse is particularly advantageous, since the known devices, particularly colonoscopes, do not allow the diagnosis of such a pathology. Indeed colonoscopes require insufflation of air which causes rectal dilation and consequently the 15 disappearance of the mucosal prolapse. In addition to what has been described above, the diagnostic device according to the present invention reduces patient's discomfort and can be used even without the administration of sedatives, being much 20 easier to introduce with respect to the known devices and does not require the insufflation of air. An additional advantage of the diagnostic device according to the present invention is linked to the small size in which it can be made, eliminating the 25 drawbacks of the direct vision anoscopes which are 19 painful and require the relaxation of the sphincter in that they have rather large dimensions. In addition to what has been stated above, the diagnostic device according to the present invention can 5 also be used on an outpatient basis, or in any case in non hospital or clinical environments, being a simple structure, easy to use and having a low cost, and which does not require the administration of sedatives. In particular providing a tip or head or distal end 10 which is non traumatic both during insertion in the closed position and during use in the open position is particularly advantageous. Furthermore, the risk that the tissue may sag or be caught in the jaws of the device is minimised or even 15 eliminated. The variety of materials with which both the inner tube and the outer tube can be made also allows the attainment of a relatively flexible elongated structure, adapted to being easily introduced in particular up to 20 the sigmoidal colon. The use of markers, both on the outer tube and on the arms allow respectively to quantify the depth of insertion of the device and to quantify the prolapse. The conformation of the device allows, in the 25 closed position, the limiting of the risk that 20 extraneous elements may introduce themselves into the interior of the device itself. The shape reached in the completely open position is particularly advantageous for initiating a response 5 from the sphincter. In addition, the shape of the arms is preferably designed such as to have maximum radial opening at the distal end of the device. It should be understood that variations and/or additions to what has been described and illustrated 10 above may be provided. The shape, both of the inner tube and the outer tube can vary with respect to what has been described and illustrated above. The materials may also be different. For example, the embodiments described above 15 provide idle arms, i.e. both the opening and closing of the arms 22 and 32 are controlled by the operator. By changing the materials, one may obtain a device in which the arms are naturally open and the shifting between the closed and open positions mainly occurs by elastic 20 effect after the physician has left the inner tube slide freely within the outer tube. The shape-coupling between the arms of the inner tube and outer tube can be different. For example, either the step 36 or tract 24b may be omitted. 25 The distal end of the device, i.e. the 21 configuration of the arms 22 and 32 may also be associated with other types of command or control of the translation of the inner tube 12 relative to the outer tube 28. For example, there may be used similar commands 5 as those that will be described below with reference to further embodiments of the diagnostic device according to the present invention. Analogously, the command for translating the inner tube 12 relative to the outer tube 28 may be used with 10 different embodiments of the distal tip. Figures 7 and 8 show a possible embodiment of the diagnostic device 10. Particularly, Figures 7 and 8 show a possible embodiment of the means generating a relative translation between the inner tube and the outer tube. 15 The elements in common with the above embodiments have been designated with the same numerals. The cylindrical cavity 15 of the grip member 14 is counter-shaped relative to the annular rib 29 of the outer tube and advantageously has the pins 31 which are 20 suitable to be inserted into the holes of the outer tube. The translation and rotation movement of the outer tube relative to the grip member are then prevented. The translation of the inner tube relative to the outer tube and grip member is controlled by a control 25 slide 42 which is suitable to be pivoted to the grip 22 member and interact with the inner tube. The control slide 42 is housed in the grip member 14 by being inserted in an aperture 40. Particularly, the control slide 42 is forked- 5 shaped. The free ends of the prongs are suitable to be inserted in the slots 16 of the inner tube. Advantageously, the control slide 42 is pivoted to the grip member in an intermediate area between the prong ends and the free end of the control slide. 10 The cylindrical cavity 15 of the grip member 14 has a notch 62 allowing the rotation of the control slide 42. The method for employing the embodiment of the above diagnostic device is described below. In general 15 terms, it is similar to that of the embodiment described above. In other words, the relative translation of the inner tube and the outer tube gradually change the configuration of the distal end of the device from a closed configuration to a completely open configuration 20 and vice versa. In the embodiment described below, the relative translation between the inner tube and the outer tube is obtained by rotating the control slide 42 relative to the grip member being held by the operator. The control 25 slide 42 acts directly on the inner tube 12 thereby 23 causing the same to rotate relative- to the grip member and the outer tube, either forwards or backwards, (arrows F and F' ) as a function of the direction of rotation of the control slide 42. 5 Depending on the materials, the opening of the arms may be either directly controlled by the physician or affected by the elasticity of the material. The advantages discussed above also find validity in the further embodiment described above. It should be 10 understood that variations and/or additions to what has been described and illustrated above may be provided. Also in this case, it may also be provided that the outer tube translates relative to the inner tube. The means suitable to generate the relative 15 translation movement between the inner tube and the outer tube as described with reference to the Figures 7- 8 can be used with any embodiment of the distal end of the device, particularly the arms 22 and 32. For example, they can be used with the embodiment shown in 20 Figures 4-6 or any other embodiment. Figure 9 shows a possible further embodiment of the diagnostic device according to the present invention. For clarity purposes, the elements in common with the above embodiments will be designated with the same 25 numerals. 24 The structure of the outer tube and the coupling thereof with the grip member 14 are substantially similar to what has been described above. The inner tube 12 comprises an end portion 64 that 5 is fitted on the proximal end of the inner tube. A pin 66 is inserted crosswise between the inner tube and the end portion thereby making the same integral to each other. The end portion has at least one groove 68 extending along the longitudinal direction of the inner 10 tube. Preferably, two grooves 68 are provided which are arranged diametrically opposed to each other on the end portion. The cylindrical cavity 15 has lugs 70 that are suitable to be inserted in the grooves 68 to prevent that the inner tube may rotate. The dimensions of the 15 lugs and respective grooves are such as to allow a relative translation of the inner tube within the outer tube such as to enable the same to shift from the two extreme open/closed configurations. The proximal end of the end portion 64 has a 20 threaded tract 72. The grip member 14 comprises a handle 7 4 that is fitted on the proximal end of the grip member 14 and provided with a threaded tract therein which is suitable to engage with the threaded tract of the end portion. 25 Preferably, the handle 74 is integral with a 25 ferrule 78 in which the threaded tract is formed. Also with this embodiment one may use a laparoscope 60 inserted within the inner tube 12 through the handle 74. 5 With reference to the definition of the device according to the present invention, the inner tube and the outer tube define the elongated structure developing between a proximal end and a distal end. The length of the elongated structure may be changed. Depending on the 10 material with which the inner tube and the outer tube are made, the elongated structure can be either semi- rigid or flexible. The control means comprise the inner tube and the outer tube that can slide one inside the other and the means which cause this relative 15 translation. The method for employing the embodiment of the above diagnostic device is described below. In general terms, it is analogous to that of the embodiment described above. In other words, the relative 20 translation of the inner tube and the outer tube gradually change the configuration of the distal end of the device from a closed configuration to a completely open configuration and vice versa. In the embodiment described above, the relative 25 translation of the inner tube within the outer tube is 26 obtained by rotating the handle 74 relative to the grip member being held by the operator. By rotating the handle, the end portion and inner tube translate relative to the grip member and the outer tube either 5 forwards or backwards (arrows F and F' ) as a function of the direction of rotation of the handle. The rotation of the inner tube is prevented by the coupling between the lugs 70 of the grip member and the grooves 68 of the end portion. 10 The relative translation between the inner tube and the outer tube causes the distal end of the device to open or close depending on the embodiment being used. In fact, the means controlling the relative translation between the inner tube and the outer tube as described 15 above can be associated with any means for widening the distal end of the device. Fox example, similar arms to those described in the embodiment illustrated in Figures 4-6 or other embodiments may be provided. The application mode and method for introduction 20 and visualization are similar to those described above for the first embodiment. The advantages discussed above also find validity in the further embodiment described above. It should be understood that variations and/or additions to what has 25 been described and illustrated above may be provided. 27 With reference to all the embodiments that have been shown and described, there may be provided different means suitable to change the configuration of the means for locally dilating the walls of the tubular 5 structure. For example, there may be provided means other than and inner tube and outer tube that can be relatively translated in order to change the configuration of the means for locally dilating the walls of the tubular structure. 10 To the preferred embodiments of the diagnostic device such as described above, those skilled in the art, aiming at satisfying contingent and specific requirements, may carry out a number of modifications, adaptations and replacement of elements with others 15 functionally equivalent, without however departing from the scope of the claims below. *** * *** 28 CLAIMS 1. A diagnostic device (10) for pathologies of tubular anatomical structures comprising: a tubular elongated structure (12, 28) developing 5 between a proximal end and a distal end and being suitable to be inserted in the tubular anatomical structure, means (22, 32) for locally dilating the walls of the tubular anatomical structure that are associated 10 with the distal end of said elongated structure, said means for locally dilating being movable between a closed position for the introduction of the device and at least one open position for the viewing and evaluation of the pathology, 15 control means being associated with the proximal end of the elongated structure, said control means being operatively connected to said means for locally dilating in order to move them between the closed position and the open position, and vice versa. 20 2. The diagnostic device according to claim 1, further comprising viewing means suitable to be associated with the elongated tubular structure and reach the tract of the tubular anatomical structure being dilated by the dilating means. 25 3. The diagnostic device according to claim 2, 29 wherein the elongated tubular structure is internally hollow in order to receive the viewing means. 4. The diagnostic device according to one of the preceding claims, wherein said locally dilating means 5 comprise arms or petals (22) that are associated with an inner tube (12) and arms or petals (32) that are associated with an outer tube (28) housing said inner tube (12) therein, said arms (32) associated with the outer tube (28) and said arms (22) associated with the 10 inner tube (12) being coupled to each other by means of shape-coupling such that to a relative translation of the inner tube and outer tube there corresponds an opening or closure of the arms (22, 32). 5 The diagnostic device according to claim 4, 15 wherein the distal end (12b) of the inner tube is operatively associated with arms or petals (22) that are formed as one piece with the inner tube (12). 6. The diagnostic device according to claim 4 or 5, wherein an arm (22) of the inner tube (12) comprises 20 a hook (24) extending towards the exterior of the arm, which is suitable to receive a coupling portion of the arms (32) of the outer tube (28). 7. The diagnostic device according to claim 6, wherein the hook (24) has an L-configuration extending 25 from one side of the arm (22) and runs down the arm in a 31 outer tube (28) within a grip member (14). 13. The diagnostic device according to claim 12, wherein said means comprise a control slide (42) having an end connected to the inner tube (12) to control the 5 translation thereof within the outer tube (28). 14. The diagnostic device according to claim 13, wherein said control slide (42) is fork-shaped, the prongs of said fork being connected to said inner tube (12). 10 15. The diagnostic device according to claim 14, wherein the prongs of said fork are suitable to be inserted in slots (16) of said inner tube (12). 16. The diagnostic device according to one of claims 13 to 15, wherein said control slide (42) is 15 pivoted on the grip member (14) and has an end outside of the grip member in order to be controlled by the operator. 17. The diagnostic device according to one of claims 13 to 16, wherein said control slide (42) is 20 pivoted on a control member (4 6) which is pivoted on the grip member (14), said control member (42) having an end external to the grip member in order to be controlled by the operator. 18. The diagnostic device according to one of 25 claims 13 to 17, wherein guide profiles (54) are 32 provided within the grip member (14) to allow the sliding of the end of the control slide (42). 19. The diagnostic device according to claim 12, wherein said means comprise a screw/nutscrew coupling 5 between the inner tube being suitable to translate within the grip member (14) and a handle (74) being fitted on the proximal end of the grip member (1.4). 20. The diagnostic device according to claim 19, wherein the handle (74) comprises a threaded tract (76) 10 that is suitable to be coupled with a threaded tract (72) associated with the inner tube (12), the inner tube being fastened to the inside of the grip member such that only the relative translation thereof is allowed. 21. The diagnostic device according to claim 20, 15 wherein the inner tube comprises an end portion (64) being integral therewith and incorporating said threaded tract (72). 22. The diagnostic device according to claim 21, wherein said end portion comprises grooves (68) being 20 suitable to receive lugs (70) of said grip member (14). A diagnostic device (10) for pathologies of tubular anatomical structures comprises a tubular elongated structure (12, 28) developing between a proximal end and a distal end and is suitable to be inserted in the tubular anatomical structure, means (22, 32) for locally dilating the walls of the tubular anatomical structure that are associated with the distal end of said elongated structure, said means for locally dilating being movable between a closed position for introducing the device and at least one open position for viewing and evaluating the pathology, and control means being associated with the proximal end of the elongated structure, said control means being operatively connected to said means for locally dilating, in order to move them between the closed position and the open position, and vice versa.

Full Text

1
"A diagnostic device"
DESCRIPTION
A diagnostic device for the pathologies of tubular
anatomical structures, such as for example the
5 intestinal tracts, is the object of the present
invention. In particular, the present invention relates
to a diagnostic device for pathologies of the colon or
the rectum such as for example intussusception,
stenosis, prolapse, rectocele.
10 The need for the availability of a diagnostic
device for the aforementioned pathologies, which can be
manufactured with limited expense, usable even in non
hospital or clinical structures and which gives rise to
the least possible discomfort in patients, avoiding for
15 example the administration of sedatives, is particularly
felt within the field. Furthermore, the need for the
availability of a diagnostic device which allows the
verification of the presence and the extent of a mucosal
prolapse is particularly felt.
20 Diagnostic devices, such as flexible colonoscopes
and sigmoidoscopes which have significant drawbacks are
known. Generally, colonoscopes work by the insufflation
of air in order to dilate the walls of the intestinal
tract subjected to analyses. The insufflation of air
25 gives rise to significant discomfort in the patients and

2
frequently it is necessary to resort to the
administration of sedatives. Furthermore, the
insufflation of air causes dilation of the rectum with
the consequence that any possible mucosal prolapse
5 disappears and may not be viewed.
Anoscopes which allow the direct vision of the area
involved and which can also be of large dimensions, for
example with diameters greater than 2 cm, are also
known, causing pain during insertion and requiring the
10 relaxation of the sphincter.
Due to the complexity and the expense of the
equipment required, in addition to the high discomfort
which they cause in patients, frequently the only
structures which are so equipped are hospitals or
15 clinics, requiring therefore that the majority of the
diagnostic procedures be carried out in such
environments.
The problem at the heart of the present invention
is that of providing a diagnostic device for the
20 pathologies of the intestinal tracts, in particular of
the rectum and colon, which has structural and
operational characteristics such as to satisfy the
aforementioned needs and to overcome the aforementioned
drawbacks cited in reference to the known art.
25 Such a problem is solved by a diagnostic device in

3
accordance with claim 1. The dependent claims refer to
further embodiments of the device according to the
present invention.
Further characteristics and advantages of the
5 diagnostic device according to the invention will arise
from the following reported description of its preferred
exemplary embodiments, which are given as non-limiting
indication, with reference to the attached figures,
wherein:
10 Figure 1 is an exploded, perspective view of a
possible embodiment of the diagnostic device according
to the present invention;
Figure 2 shows a side view of the diagnostic device
from figure 1, where several details have been omitted
15 in order to enhance other ones;
Figure 3 shows the diagnostic device from Figure 2
in a different operating condition;
Figure 4 shows a perspective view of a detail of
the distal end of a diagnostic device according to the
20 present invention, in accordance with a possible
embodiment and in a first operating condition;
Figure 5 shows a perspective view of the detail
from Figure 4 in a second operating condition;
Figure 6 illustrates an exploded, perspective view
25 of two components of the detail from Figure 4 or 5;

4
Figure 7 is a partially exploded, perspective view
of a possible embodiment of the diagnostic device
according to the present invention;
Figure 8 shows a perspective view of a detail of
5 the diagnostic device from Figure 7, when assembled,
where several details have been omitted in order to
enhance other ones;
Figure 9 is a partially exploded, perspective view
of a possible embodiment of the diagnostic device
10 according to the present invention;
The present invention generally relates to a
diagnostic device for pathologies of tubular anatomical
structures, such as the intestinal tracts for example of
the rectum and colon. In general terms the device
15 advantageously comprises an elongated structure which
develops between a proximal end and a distal end and
which is suitable for being inserted within the anatomic
structure to be examined. Means for locally dilating the
walls of the tubular structure associated with the
20 distal end of the elongated structure are further
provided. The means for dilating are movable between a
closed position for the introduction of the device and
at least one open position for the viewing and the
evaluation of the pathology.
25 The means for locally dilating are operatively

5
connected with control means associated with the
proximal end of the elongated structure. These control
means are actuated by the operator in order to open or
close the dilating means.
5 In addition, viewing means suitable for being
associated with the elongated structure and for reaching
the tract dilated by the means of dilating are provided.
In general terms, which can be applied to any
embodiment of the device according to the present
10 invention, by proximal is conventionally meant either a
portion or end of the device which, whilst in use, is
near to the operator holding the device and carrying out
the examination, whereas by distal is conventionally
meant either a portion or end of the device which,
15 whilst in use, is remote with respect to the operator
carrying out the examination. Furthermore, by the term
advancement is meant a movement, preferably translation,
carried out in the direction from the proximal end
towards the distal end (for example along the arrow F of
20 Figure 3) , whereas by withdrawal is meant a movement,
preferably translation, carried out in the direction
from the distal end towards the proximal end (for
example along the arrow F' of Figure 2).
Some embodiments of such a device will be described
25 below, for example with reference to the annexed

6
figures.
With reference to the Figures 1-3, by 10 has been
generally indicated a trans-anal diagnostic device
according to a first embodiment. The elements in common
5 throughout the illustrated embodiments will be described
and designated with the same numeral.
With 12 has been designated an inner tube
preferably of a cylindrical shape and hollow inside. The
inner tube 12 may be for example in semi-rigid or
10 flexible material, for example in plastic material.
The inner tube 12 extends between a proximal end
12a and a distal end 12b. The proximal end 12a is
operatively associated with a grip member 14, for
example in the shape of a handle. More in particular,
15 the inner tube is partially housed within a cylindrical
cavity 15 of the grip member 14 and is free to slide
therein along its longitudinal axis.
According to a possible embodiment, two slots 16
are formed in portions that are diametrically opposed to
20 the inner tube 12 and near the proximal end 12a. More
in particular, the slot 16 extends in the
circumferential direction relative to the inner tube 12.
Preferably both slots pass through the entire thickness
of the inner tube 12.
25 The distal end 12b of the inner tube is operatively

7
linked to arms or petals 22 preferably extending in the
longitudinal direction relative to the inner tube 12.
Advantageously, the arms 22 are formed as one piece with
the inner tube 12. A possible embodiment of the arms 22
5 will be described below with reference to Figures 4-6.
Figures 4-6, in fact, show an enlarged detail of
the distal end of the diagnostic device.
In accordance with a possible embodiment, an arm 22
of the inner tube 12 comprises a hook 24 extending out
10 of the arm, in a substantially radial direction. More in
detail, the hook 24 has an L-configuration extending
from one side of arm 22 and runs down the arm in a
crosswise manner. In other words, the hook 24 defines a
seat being laterally opened on arm 22. Yet in other
15 words, the hook 24 comprises a first tract 24a extending
from the arm 22 perpendicular thereto and towards the
exterior of the arm, and a second tract 24b extending
perpendicular to the first one crosswise to the
longitudinal development of the arm 22. Preferably, the
20 length of second tract as measured along the
longitudinal direction of arm 22 is greater than that of
the first tract. Furthermore, the second tract
preferably extends along a width, as measured crosswise
to the longitudinal direction of the arm, which is equal
25 to about the width of the arm.

8
In accordance with a possible embodiment, the free
end 22a of the arms has an enlargement 26 such as to
have a greater thickness than the remaining portion of
the arm. Advantageously, the enlargement 26 is arranged
5 at the hook 24.
The arms 22 are suitable to assume at least two
extreme configurations corresponding to a closed
configuration (Figure 5) and completely open
configuration (Figure 4) . In the closed configuration,
10 the free ends of the arms 22 are in contact to each
other and the tip or distal end of the diagnostic device
is substantially olive-shaped. In the open
configuration, the arms 22 mutually detach and assume a
configuration which is substantially cup-shaped.
15 In accordance with a possible embodiment, at least
one of the arms 22 has detection elements or markers 27
therein, which are preferably numerated along the
longitudinal direction of the arm in order to evaluate
the extent of the pathology encountered.
20 With reference to the embodiment illustrated in
Figures 1-3, an outer tube has been overall designated
with 28. In the assembled configuration of the device
10, the outer tube 28 houses the inner tube 12 therein.
With reference also to the outer tube 28 a proximal end
25 designated with 28a and a distal end designated with 28b

9
can be identified. According to a possible embodiment,
the outer tube 28 can be made of semi-rigid or flexible
material, for example of plastic material.
According to a possible embodiment, the outer tube
5 28 may have one or more detection elements or markers
30, for example distributed along the length of the
outer tube itself, in order to measure the length of
penetration of the device inside the anus and
accordingly the location of the pathology encountered.
10 According to one possible embodiment the markers 30
have the shape of circular rings that are arranged
transversal to the tube, which are preferably numerated
and distributed along the length of the outer tube.
In accordance with a possible embodiment, the
15 proximal end 28a of the outer tube has an annular rib
29. In accordance with a further embodiment, the
proximal end 28a of the outer tube has at least one hole
31, preferably two holes that are arranged diametrically
opposed on the outer tube and preferably passing through
20 the thickness of the outer tube. In the event that both
the annular rib 29 and the holes 31 are advantageously
provided, the latter are formed at the annular rib.
Advantageously, the outer tube 28 is shorter than
the inner tube 12 such that a portion of the inner tube
25 starting from the proximal end of the inner tube

10
projects from the proximal end of the outer tube, for
example within the cylindrical cavity 15 of the grip
member 14.
In accordance with a possible embodiment, the outer
5 tube and the inner tube are partially housed within the
grip member 14, more precisely within the cylindrical
cavity 15.
The distal end 28b of the outer tube is operatively
linked to arms or petals 32 preferably extending in the
10 longitudinal direction relative to the outer tube 28.
Advantageously, the arms 32 are formed as one piece with
the outer tube 28. Figures 4-6 show in detail a possible
embodiment of the arms 32 of the outer tube.
To each arm 22 of the inner tube 12 there
15 corresponds an arm 32 of the outer tube 28, and in the
assembled configuration of the device 10, the two
associated arms overlap.
In accordance with a possible embodiment, the arms
22 of the inner tube 12 and the arms 32 of the outer
20 tube 28 have such a configuration suitable to mutual
coupling, particularly by means of a shape-coupling that
allows to control the opening and closure of the arms 32
of the outer tube 28 by opening and closing the arms 22
of the inner tube 12.
25 With reference to Figures 4-6 and particularly

11
Figure 6, each arm 32 has a seat 34 on the side thereof
which is suitable to receive a portion of the hook 24
and particularly the first tract 24a. Furthermore, the
distal end of the arms 32 has a step 36 suitable to abut
5 against the hook 24, and particularly against the second
tract 24b.
The mutual assembly of the arms 22 of the inner
tube 12 and the arms 32 of the outer tube 28 provides
that one tube is inserted inside the other such that the
10 respective arms are slightly angularly offset. A slight
mutual rotation of the two tubes will bring each arm 32
of the outer tube into the seat being defined by the
respective hook 24. The seat 34 houses the first tract
24a whereas the second tract 24b abuts against the step
15 36.
Preferably, the thickness of step 36 decreases
towards the free end of the arm 32.
The arms 32 of the outer tube 28 are suitable for
assuming at least two extreme configurations
20 corresponding to a closed configuration (Figure 5) and a
completely open configuration (Figure 4). In the closed
configuration, the free ends of the arms 32 are in
contact to each other and the tip or distal end of the
diagnostic device is substantially olive-shaped. In the
25 open configuration, the arms 32 mutually detach and

12
assume a configuration which is substantially cup-
shaped.
The passage between the two open/closed extreme
positions of the distal end of the device is carried out
5 by means of a relative translation of the inner tube 12
and the outer tube 28. Advantageously, the arms 32 of
the outer tube 28 are idle and controlled by the arms 22
of the inner tube both for opening and closing.
Considering the stationary outer tube and the
10 moving inner tube, by making the inner tube advance
along the arrow F one passes from the closed
configuration (Figure 5) to the open configuration
(Figure 4) . In fact, both the first tract 24a and the
second tract 24b push each arm 32 of the outer tube to a
15 radially wider position. On the contrary, a backward
movement of the inner tube along the arrow F' causes the
arms 22 of the inner tube and 32 of the outer tube to
shift from the open configuration (Figure 4) to the
closed configuration (Figure 5) . In fact, the first
20 tract 24a of the hook 24 cooperates with the arm 32 of
the outer tube 28, within the seat 34, whereas the
second tract 24b cooperates with the outer surface of
the arm 32 by dragging each corresponding arm 32 of the
outer tube 28 to closure.
25 According to a possible embodiment, a membrane 38

13
preferably made from plastic or foldable material is fit
on the distal end of the outer tube 28, i.e. on the arms
32. According to a possible embodiment, the membrane is
made from transparent material.
5 Figures 1-3 show a possible embodiment of the means
for actuating a relative translation movement between
the inner tube 12 and the outer tube 28. Specifically,
these means are suitable for translating the inner tube
12 relative to the stationary outer tube 28, but it may
10 also be provided otherwise.
The grip member 14 has an elongated opening 49
allowing the connection between the inner tube 12 and a
control slide 42. Preferably, the control slide is fork-
shaped in order to be connected to the inner tube at
15 portions diametrically opposed thereon.
Particularly, the contxol slide 42 has ends that
are suitable to be inserted in the slots 16 of the inner
tube, from the outside of the inner tube. In the case
where the control slide is fork-shaped, the ends of the
20 prongs comprise relative pins 44 which are suitable to
be inserted into the slots 16.
A control member 46 is operatively associated with
the control slide 42 to generate a forward and backward
motion of the inner tube within the outer tube.
25 Advantageously, the control member 4 6 is configured

14
as a lever with an end connected to the grip member 14
by means of a pin 48. The connection between the control
member 46 and the control slide 42 is provided by a
further pin 50 that is mounted on the control member 46
5 in an intermediate area between the pin 40 and the free
end of the control member 46.
In accordance with a possible embodiment, the grip
member 14 comprises a ring 52 to receive the thumb of
the operator's hand.
10 According to an advantageous embodiment, besides to
what has been described above, there is provided a guide
profile 54 which is housed in a longitudinal groove 56
of the grip member 14. The pins 44 also extend outside
the inner tube for being inserted into the guide profile
15 54.
In accordance with a possible embodiment, the
cylindrical cavity 15 of the grip member 14 is counter-
shaped relative to the annular rib 29 of the outer tube
such as to prevent that the outer tube may translate
20 within the grip member 14. Furthermore, the cylindrical
cavity 15 may have pins 58 suitable to be inserted in
the holes 31, if provided, of the outer tube in order to
prevent that the outer tube may rotate within the grip
member 14.
25 With reference to the embodiment illustrated in

15
Figures 1-3, the operator holds the grip member 14, by
passing his thumb through the ring 52, if present, and
gripping the control member 46.
From the open position from Figure 1 or 3, the
5 operator rotates the control member 46 by closing the
same towards the grip member body. The control slide 42
pushes the inner tube 12 backwards thereby closing the
arms of the inner tube and the outer tube such as
described above. The pins 44 are free to slide along the
10 slots 16 in the circumferential direction relative to
the tube. The cylindrical cavity 15 has such an
extension allowing a translation movement of the inner
tube that is sufficient for the arms to shift between
the two extreme open/closed positions.
15 With reference to the definition of the device
according to the present invention, the inner tube and
the outer tube define the elongated structure developing
between a proximal end and a distal end. The length of
the elongated structure may be changed. As a function of
20 the material with which the inner tube and the outer
tube are made, the elongated structure can be either
semi-rigid or flexible. The arms 22 of the device 10
define means for locally dilating the walls of the
anatomical structure of interest, which are associated
25 with the distal end of the elongated structure. The

16
control means comprise the inner tube and the outer tube
which can slide one inside the other and the means which
cause this relative translation.
The device 10 in the closed position is introduced
5 transanally into the rectum/colon sigmoid/colon of the
patient by the physician or the operator carrying out
the examination. The degree of introduction of the
device 10 can be verified using the markers 30 on the
outer tube 28, if present. The insertion of the device
10 10 is facilitated by the olive-shape of the distal tip
of the device, i.e. of the arms 22 and 32.
When the desired position has been reached, the
distal end of the device is opened "flower-like" such as
to gradually widen the area of interest, as will be
15 described below with reference to the embodiment in
question.
The operations described above for opening the
distal end of the device 10, in which a translation of
the inner tube 12 is provided to be generated relative
20 to the grip member 14 and outer tube 28, can be
similarly carried out by generating a translation of the
outer tube relative to the inner tube and grip member.
The device 10 described above may be used in
association with viewing equipment (for example
25 laparoscopes 60) which are introduced into the inner

17
tube 12 and which, thanks to the opening of the arms 22,
can be directed towards the appropriately widened area
of interest such that the operator (physician) can check
for the presence and the extent of the various
5 pathologies. In other words the inner tube 12 allows the
passage of illuminating and optical elements for the
viewing of the area of interest.
Alternatively, the device 10 can be associated with
an apparatus provided with a colon-scope and
10 insufflation device available from specialist medical
practitioners.
By gradually and selectively widening the distal
end of the device 10, for example, one can check the
response of the mucosa by mimicking defecation.
15 The present device allows the diagnosis of various
pathologies among which intussusception, stenosis,
prolapse, rectocele. The location of the defect can be
quantified by means of the markers arranged on the outer
tube. The extent of the defect can be quantified as a
20 function of the location to which the mucosa falls along
the markers on the arms.
The device 10 can additionally be moved backwards
or forwards while opening and closing the same in order
to allow the analyses of the various sections of tissues
25 and in order to diagnose the conditions of the prolapse.

18
From what has been stated above, one can appreciate
how providing a diagnostic device according to the
present invention allows to have available a low cost
device useful in the diagnosis of pathologies of tubular
5 anatomical structures such as colon-rectal tracts. For
example it is possible to identify and evaluate
pathologies like intestinal blockages, intussusception,
stenosis, prolapse and rectocele.
Being capable of carrying out the diagnosis and
10 quantification of a rectal prolapse is particularly
advantageous, since the known devices, particularly
colonoscopes, do not allow the diagnosis of such a
pathology. Indeed colonoscopes require insufflation of
air which causes rectal dilation and consequently the
15 disappearance of the mucosal prolapse.
In addition to what has been described above, the
diagnostic device according to the present invention
reduces patient's discomfort and can be used even
without the administration of sedatives, being much
20 easier to introduce with respect to the known devices
and does not require the insufflation of air.
An additional advantage of the diagnostic device
according to the present invention is linked to the
small size in which it can be made, eliminating the
25 drawbacks of the direct vision anoscopes which are

19
painful and require the relaxation of the sphincter in
that they have rather large dimensions.
In addition to what has been stated above, the
diagnostic device according to the present invention can
5 also be used on an outpatient basis, or in any case in
non hospital or clinical environments, being a simple
structure, easy to use and having a low cost, and which
does not require the administration of sedatives.
In particular providing a tip or head or distal end
10 which is non traumatic both during insertion in the
closed position and during use in the open position is
particularly advantageous.
Furthermore, the risk that the tissue may sag or be
caught in the jaws of the device is minimised or even
15 eliminated.
The variety of materials with which both the inner
tube and the outer tube can be made also allows the
attainment of a relatively flexible elongated structure,
adapted to being easily introduced in particular up to
20 the sigmoidal colon.
The use of markers, both on the outer tube and on
the arms allow respectively to quantify the depth of
insertion of the device and to quantify the prolapse.
The conformation of the device allows, in the
25 closed position, the limiting of the risk that

20
extraneous elements may introduce themselves into the
interior of the device itself.
The shape reached in the completely open position
is particularly advantageous for initiating a response
5 from the sphincter. In addition, the shape of the arms
is preferably designed such as to have maximum radial
opening at the distal end of the device.
It should be understood that variations and/or
additions to what has been described and illustrated
10 above may be provided.
The shape, both of the inner tube and the outer
tube can vary with respect to what has been described
and illustrated above. The materials may also be
different. For example, the embodiments described above
15 provide idle arms, i.e. both the opening and closing of
the arms 22 and 32 are controlled by the operator. By
changing the materials, one may obtain a device in which
the arms are naturally open and the shifting between the
closed and open positions mainly occurs by elastic
20 effect after the physician has left the inner tube slide
freely within the outer tube.
The shape-coupling between the arms of the inner
tube and outer tube can be different. For example,
either the step 36 or tract 24b may be omitted.
25 The distal end of the device, i.e. the

21
configuration of the arms 22 and 32 may also be
associated with other types of command or control of the
translation of the inner tube 12 relative to the outer
tube 28. For example, there may be used similar commands
5 as those that will be described below with reference to
further embodiments of the diagnostic device according
to the present invention.
Analogously, the command for translating the inner
tube 12 relative to the outer tube 28 may be used with
10 different embodiments of the distal tip.
Figures 7 and 8 show a possible embodiment of the
diagnostic device 10. Particularly, Figures 7 and 8 show
a possible embodiment of the means generating a relative
translation between the inner tube and the outer tube.
15 The elements in common with the above embodiments have
been designated with the same numerals.
The cylindrical cavity 15 of the grip member 14 is
counter-shaped relative to the annular rib 29 of the
outer tube and advantageously has the pins 31 which are
20 suitable to be inserted into the holes of the outer
tube. The translation and rotation movement of the outer
tube relative to the grip member are then prevented.
The translation of the inner tube relative to the
outer tube and grip member is controlled by a control
25 slide 42 which is suitable to be pivoted to the grip

22
member and interact with the inner tube. The control
slide 42 is housed in the grip member 14 by being
inserted in an aperture 40.
Particularly, the control slide 42 is forked-
5 shaped. The free ends of the prongs are suitable to be
inserted in the slots 16 of the inner tube.
Advantageously, the control slide 42 is pivoted to the
grip member in an intermediate area between the prong
ends and the free end of the control slide.
10 The cylindrical cavity 15 of the grip member 14 has
a notch 62 allowing the rotation of the control slide
42.
The method for employing the embodiment of the
above diagnostic device is described below. In general
15 terms, it is similar to that of the embodiment described
above. In other words, the relative translation of the
inner tube and the outer tube gradually change the
configuration of the distal end of the device from a
closed configuration to a completely open configuration
20 and vice versa.
In the embodiment described below, the relative
translation between the inner tube and the outer tube is
obtained by rotating the control slide 42 relative to
the grip member being held by the operator. The control
25 slide 42 acts directly on the inner tube 12 thereby

23
causing the same to rotate relative- to the grip member
and the outer tube, either forwards or backwards,
(arrows F and F' ) as a function of the direction of
rotation of the control slide 42.
5 Depending on the materials, the opening of the arms
may be either directly controlled by the physician or
affected by the elasticity of the material.
The advantages discussed above also find validity
in the further embodiment described above. It should be
10 understood that variations and/or additions to what has
been described and illustrated above may be provided.
Also in this case, it may also be provided that the
outer tube translates relative to the inner tube.
The means suitable to generate the relative
15 translation movement between the inner tube and the
outer tube as described with reference to the Figures 7-
8 can be used with any embodiment of the distal end of
the device, particularly the arms 22 and 32. For
example, they can be used with the embodiment shown in
20 Figures 4-6 or any other embodiment.
Figure 9 shows a possible further embodiment of the
diagnostic device according to the present invention.
For clarity purposes, the elements in common with the
above embodiments will be designated with the same
25 numerals.

24
The structure of the outer tube and the coupling
thereof with the grip member 14 are substantially
similar to what has been described above.
The inner tube 12 comprises an end portion 64 that
5 is fitted on the proximal end of the inner tube. A pin
66 is inserted crosswise between the inner tube and the
end portion thereby making the same integral to each
other. The end portion has at least one groove 68
extending along the longitudinal direction of the inner
10 tube. Preferably, two grooves 68 are provided which are
arranged diametrically opposed to each other on the end
portion. The cylindrical cavity 15 has lugs 70 that are
suitable to be inserted in the grooves 68 to prevent
that the inner tube may rotate. The dimensions of the
15 lugs and respective grooves are such as to allow a
relative translation of the inner tube within the outer
tube such as to enable the same to shift from the two
extreme open/closed configurations.
The proximal end of the end portion 64 has a
20 threaded tract 72.
The grip member 14 comprises a handle 7 4 that is
fitted on the proximal end of the grip member 14 and
provided with a threaded tract therein which is suitable
to engage with the threaded tract of the end portion.
25 Preferably, the handle 74 is integral with a

25
ferrule 78 in which the threaded tract is formed.
Also with this embodiment one may use a laparoscope
60 inserted within the inner tube 12 through the handle
74.
5 With reference to the definition of the device
according to the present invention, the inner tube and
the outer tube define the elongated structure developing
between a proximal end and a distal end. The length of
the elongated structure may be changed. Depending on the
10 material with which the inner tube and the outer tube
are made, the elongated structure can be either semi-
rigid or flexible. The control means comprise the inner
tube and the outer tube that can slide one inside the
other and the means which cause this relative
15 translation.
The method for employing the embodiment of the
above diagnostic device is described below. In general
terms, it is analogous to that of the embodiment
described above. In other words, the relative
20 translation of the inner tube and the outer tube
gradually change the configuration of the distal end of
the device from a closed configuration to a completely
open configuration and vice versa.
In the embodiment described above, the relative
25 translation of the inner tube within the outer tube is

26
obtained by rotating the handle 74 relative to the grip
member being held by the operator. By rotating the
handle, the end portion and inner tube translate
relative to the grip member and the outer tube either
5 forwards or backwards (arrows F and F' ) as a function of
the direction of rotation of the handle.
The rotation of the inner tube is prevented by the
coupling between the lugs 70 of the grip member and the
grooves 68 of the end portion.
10 The relative translation between the inner tube and
the outer tube causes the distal end of the device to
open or close depending on the embodiment being used.
In fact, the means controlling the relative translation
between the inner tube and the outer tube as described
15 above can be associated with any means for widening the
distal end of the device. Fox example, similar arms to
those described in the embodiment illustrated in Figures
4-6 or other embodiments may be provided.
The application mode and method for introduction
20 and visualization are similar to those described above
for the first embodiment.
The advantages discussed above also find validity
in the further embodiment described above. It should be
understood that variations and/or additions to what has
25 been described and illustrated above may be provided.

27
With reference to all the embodiments that have
been shown and described, there may be provided
different means suitable to change the configuration of
the means for locally dilating the walls of the tubular
5 structure. For example, there may be provided means
other than and inner tube and outer tube that can be
relatively translated in order to change the
configuration of the means for locally dilating the
walls of the tubular structure.
10 To the preferred embodiments of the diagnostic
device such as described above, those skilled in the
art, aiming at satisfying contingent and specific
requirements, may carry out a number of modifications,
adaptations and replacement of elements with others
15 functionally equivalent, without however departing from
the scope of the claims below.
*** * ***

28
CLAIMS
1. A diagnostic device (10) for pathologies of
tubular anatomical structures comprising:
a tubular elongated structure (12, 28) developing
5 between a proximal end and a distal end and being
suitable to be inserted in the tubular anatomical
structure,
means (22, 32) for locally dilating the walls of
the tubular anatomical structure that are associated
10 with the distal end of said elongated structure, said
means for locally dilating being movable between a
closed position for the introduction of the device and
at least one open position for the viewing and
evaluation of the pathology,
15 control means being associated with the proximal
end of the elongated structure, said control means being
operatively connected to said means for locally dilating
in order to move them between the closed position and
the open position, and vice versa.
20 2. The diagnostic device according to claim 1,
further comprising viewing means suitable to be
associated with the elongated tubular structure and
reach the tract of the tubular anatomical structure
being dilated by the dilating means.
25 3. The diagnostic device according to claim 2,

29
wherein the elongated tubular structure is internally
hollow in order to receive the viewing means.
4. The diagnostic device according to one of the
preceding claims, wherein said locally dilating means
5 comprise arms or petals (22) that are associated with an
inner tube (12) and arms or petals (32) that are
associated with an outer tube (28) housing said inner
tube (12) therein, said arms (32) associated with the
outer tube (28) and said arms (22) associated with the
10 inner tube (12) being coupled to each other by means of
shape-coupling such that to a relative translation of
the inner tube and outer tube there corresponds an
opening or closure of the arms (22, 32).
5 The diagnostic device according to claim 4,
15 wherein the distal end (12b) of the inner tube is
operatively associated with arms or petals (22) that are
formed as one piece with the inner tube (12).
6. The diagnostic device according to claim 4 or
5, wherein an arm (22) of the inner tube (12) comprises
20 a hook (24) extending towards the exterior of the arm,
which is suitable to receive a coupling portion of the
arms (32) of the outer tube (28).
7. The diagnostic device according to claim 6,
wherein the hook (24) has an L-configuration extending
25 from one side of the arm (22) and runs down the arm in a

31
outer tube (28) within a grip member (14).
13. The diagnostic device according to claim 12,
wherein said means comprise a control slide (42) having
an end connected to the inner tube (12) to control the
5 translation thereof within the outer tube (28).
14. The diagnostic device according to claim 13,
wherein said control slide (42) is fork-shaped, the
prongs of said fork being connected to said inner tube
(12).
10 15. The diagnostic device according to claim 14,
wherein the prongs of said fork are suitable to be
inserted in slots (16) of said inner tube (12).
16. The diagnostic device according to one of
claims 13 to 15, wherein said control slide (42) is
15 pivoted on the grip member (14) and has an end outside
of the grip member in order to be controlled by the
operator.
17. The diagnostic device according to one of
claims 13 to 16, wherein said control slide (42) is
20 pivoted on a control member (4 6) which is pivoted on the
grip member (14), said control member (42) having an end
external to the grip member in order to be controlled by
the operator.
18. The diagnostic device according to one of
25 claims 13 to 17, wherein guide profiles (54) are

32
provided within the grip member (14) to allow the
sliding of the end of the control slide (42).
19. The diagnostic device according to claim 12,
wherein said means comprise a screw/nutscrew coupling
5 between the inner tube being suitable to translate
within the grip member (14) and a handle (74) being
fitted on the proximal end of the grip member (1.4).
20. The diagnostic device according to claim 19,
wherein the handle (74) comprises a threaded tract (76)
10 that is suitable to be coupled with a threaded tract
(72) associated with the inner tube (12), the inner tube
being fastened to the inside of the grip member such
that only the relative translation thereof is allowed.
21. The diagnostic device according to claim 20,
15 wherein the inner tube comprises an end portion (64)
being integral therewith and incorporating said threaded
tract (72).
22. The diagnostic device according to claim 21,
wherein said end portion comprises grooves (68) being
20 suitable to receive lugs (70) of said grip member (14).

A diagnostic device (10) for pathologies of tubular
anatomical structures comprises a tubular elongated
structure (12, 28) developing between a proximal end and
a distal end and is suitable to be inserted in the
tubular anatomical structure, means (22, 32) for locally
dilating the walls of the tubular anatomical structure
that are associated with the distal end of said
elongated structure, said means for locally dilating
being movable between a closed position for introducing
the device and at least one open position for viewing
and evaluating the pathology, and control means being
associated with the proximal end of the elongated
structure, said control means being operatively
connected to said means for locally dilating, in order
to move them between the closed position and the open
position, and vice versa.

Documents:

http://ipindiaonline.gov.in/patentsearch/GrantedSearch/viewdoc.aspx?id=JplCF/mLQI+Nw9AhoWdknQ==&loc=wDBSZCsAt7zoiVrqcFJsRw==

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Patent Number

268806

Indian Patent Application Number

1336/KOLNP/2007

PG Journal Number

38/2015

Publication Date

18-Sep-2015

Grant Date

17-Sep-2015

Date of Filing

17-Apr-2007

Name of Patentee

ETHICON ENDO-SURGERY, INC

Applicant Address

4545 CREEK ROAD CINCINNATI, OH

Inventors:

#	Inventor's Name	Inventor's Address
1	KUHNS, JESSE, J	2083 TRAILWOOD DRIVE CINCINNATI, OHIO 45230
2	LONGO ANTONIO	VIA MAQUEDA, 8 I-90134 PALERMO
3	BILLOTTI FEDERICO	VIA PADRE G.A. FILIPPINI, 109 I-00144 ROMA
4	D'ARCANGELO MICHELE	VIA BENEDETTO CROCE, 26 I-00142 ROMA
5	HESS CHRISTOPHER, J	1704 EAST MCMILLAN ST. CINCINNATI, OHIO 45206
6	WEISENBURGH, WILLIAM, BRUCE, II	974 AIRYMEADOWS DR. MAINEVILLE, OHIO 45039

PCT International Classification Number

A61B 1/31

PCT International Application Number

PCT/IT2005/000345

PCT International Filing date

2005-06-16

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	MI2004A002079	2004-10-29	Italy