• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    endoscopic glove. The present invention relates to an endoscopic glove that includes a tubular element from which spaced projecting elements extend. the projecting elements are collapsible to both the proximal and distal directions of the tubular element. the force (insertion force) required to bend elements projecting to the proximal direction is less than a force (extraction force) required to bend elements projecting to the distal direction. an outer periphery of the projecting elements decreases as the pulling force increases.
    公开号:BR112015018903B1
    申请号:R112015018903-2
    申请日:2013-06-06
    公开日:2022-01-04
    发明作者:Dan Rottenberg；Omer Shezifi
    申请人:Endoaid Ltd；
    IPC主号:
    专利说明:

    FIELD OF THE INVENTION
    [001] The present invention relates to a glove or cuff having external projections, for example full or partial rings or wings, for use with medical endoscopes, particularly, but not exclusively, a colonoscope. BACKGROUND OF THE INVENTION
    [002] In endoscopic examinations/procedures, flexible instruments are used to visualize a lumen of the body, such as the gastrointestinal tract and many others. The instruments are supplied with fiber optic or charge-coupled device (CCD) cameras that allow images to be transmitted around curves and images to be produced for display on a screen.
    [003] For example, colonoscopic and enteroscopic examinations are the most effective techniques to assess the health status of the gut. However, they are inconvenient, uncomfortable and expensive procedures that are associated with significant risks of potentially serious complications. An additional disadvantage is that they are time consuming for patients and medical personnel.
    [004] Four additional significant difficulties associated with colonoscopy procedure and evaluation more generally are as follows:
    [005] First, the anatomy of the colon is such that the lining is laid in curves. When the endoscope tip passes along the lumen of the colon, these curves hinder the endoscopist's ability to visualize the entire mucosal surface and, in particular, detect occult premalignant or malignant lesions on the proximal surface of these curves during extubation.
    [006] Second, the position of the tip can be difficult to maintain once a lesion or polyp is detected at the conclusion of any therapeutic procedure. As the colonoscope is moving, the tip does not travel back at a constant speed but instead with jerks and slides particularly when traversing a curve or length of colon where the bowel has been fitted over the axis of the endoscope during intubation. The tip of the device may, at any time, slide backwards thereby causing the clinician to lose position. If tip position is lost, the physician must relocate the lesion or polyp for the therapeutic procedure to continue.
    [007] Thirdly, the bowel tissue is flexible and can fall over the distal end of the endoscope, disturbing the camera/video image view.
    [008] Fourth, fecal debris and fluid can hide the walls of the colon, preventing proper examination of colon tissue.
    [009] The colonoscopy procedure is not simple because the intestine is long and coiled. In places it is tied by peritoneal bands and in others it is relatively free. When the endoscope tip encounters a tight bend, the free part of the colon "turns around" as more of the endoscope is introduced and makes it difficult to get around the bend.
    [0010] PCT Patent Application WO 2011/148172 describes a sleeve for a medical endoscope distal section. The sleeve has a number of inclined, external, movable projecting elements, having a tip and a base, which are movable between an inclined resting position and a position where the tip of the projecting element is substantially parallel to a longitudinal axis of the medical endoscope, and for a position that is at an angle approximately perpendicular to the longitudinal axis of the medical endoscope. The device is intended to close the projection elements while the medical endoscope is moving forward (distally), and to open the projection elements during withdrawal of the medical endoscope (proximally), thereby helping to open the curves of the colon to better examine the colonic mucosa during endoscope withdrawal (only). As bowel tracking is not normally done in a withdrawal movement, but in short back and forth movements, such projection elements may not achieve a perpendicular position with respect to the longitudinal axis of the medical endoscope.
    [0011] PCT Patent Application WO00/13736 describes an apparatus for percutaneous insertion into the cardiovascular system, it includes a catheter or catheter guide having a distal end, and generally radial, permanently extended, flexible protuberances (e.g., flexible fins thin or radially spaced fins) located adjacent to the distal tip of the catheter. SUMMARY
    [0012] Reference herein to a "medical evaluation device" is intended to encompass endoscopes, enteroscopes, gastroscopes, colonoscopes and other types of endoscopes, and is used interchangeably and is intended to include all evaluation instruments inserted into or through a body/organ/tissue lumen or cavity (used interchangeably). Endoscopy involves the inspection and treatment of the interior of the lumen or body cavity.
    [0013] According to an embodiment of the invention, an endoscopic sleeve is provided that includes a tubular element from which several spaced projecting elements extend. The projecting elements are bendable to the proximal and distal directions of the tubular element, the force (insertion force) required to bend the projecting elements to the proximal direction is less than a force (extraction force) required to bend the projecting elements to the distal direction. An outer periphery of the projecting elements decreases as the pulling force increases. Projected elements may be more bendable in the proximal direction than in the distal direction.
    [0014] The projected elements can be movable between at least three positions. In a first position, the projected elements project freely, at an angle, such as perpendicular to the longitudinal axis of the endoscope (so-called "rest position"). In a second position, when the sleeved endoscope is introduced distally into a body lumen, insertion forces act on the thin projecting elements to push them proximally backwards in the direction of the endoscope axis so that they can become skewed or tilted. even substantially parallel to the longitudinal axis of the endoscope, reducing the overall diameters of the device and sleeve. In a third position, when the endoscope is withdrawn in a proximal direction of the patient's lumen, the thin projecting elements are bent by extraction forces, this time in the other direction (distally). The projecting elements diverge and extend from the endoscope axis so as to gently contact or grip the inner surface of the body lumen. During extraction, the total diameters of the device and sleeve also decrease.
    [0015] The projecting elements can be multiple thin rings (partial or full), or wings, which are arranged circumferentially around the sleeve and along the length of the sleeve. Without limitation, there can be between 2 and 30 projected elements. It will be appreciated that the designed elements may, in some embodiments, be provided as a single ring. Each designed element can have the same thickness, or different designed elements can have different thicknesses. The projected element can have a variable thickness along its extended outside diameter or its perimeter. Without limitation, each projecting element may have an external diameter between 20 to 60 mm, and more preferably between 30 to 50 mm, with a thickness between 0.2 to 2.0 mm, and most preferably 0.3 to 1.0 mm . All engineered elements may have the same diameter, or different engineered elements may have different diameters. Projected elements may be spaced by a distance between 1 to 10 mm or more preferably 2 mm to 5 mm. Different sizes of spaces can be used for different designed elements. BRIEF DESCRIPTION OF THE DRAWINGS
    [0016] Embodiments of the invention are further described hereinafter with reference to the accompanying drawings, in which:
    [0017] Figure 1 is a simplified illustration of an endoscopic sleeve, constructed and operative in accordance with an embodiment of the invention, mounted on an endoscope and inserted into a body lumen;
    [0018] Figures 2A and 2B are simplified illustrations of the endoscopic sleeve and endoscope, respectively during distal movement and proximal movement of the endoscope in the body lumen, according to an embodiment of the invention;
    [0019] Figures 3A, 3B and 3C are simplified illustrations of an endoscopic glove constructed and operative in accordance with an embodiment of the invention, wherein projecting elements of the endoscopic glove are generally perpendicular to a tubular element of the glove (Figure 3A). ), or curved towards the proximal direction (figure 3B) or curved towards the distal direction (figure 3C);
    [0020] Figure 4 is a simplified illustration of an endoscopic glove constructed and operative in accordance with another embodiment of the invention, including projecting elements (wings) that are bendable in the proximal rather than the distal direction;
    [0021] Figure 5 is a simplified illustration of an endoscopic sleeve with seals at its distal and proximal ends, according to an embodiment of the invention;
    [0022] Figures 6A and 6B are simplified top view and side view illustrations, respectively, of an endoscopic glove, constructed and operative in accordance with another embodiment of the invention, in which the projecting elements are distinct wings, and in which the figure 6B illustrates distally curved proximal projecting elements versus uncurved distal projecting elements;
    [0023] Figure 7 is a simplified illustration of an endoscopic glove constructed and operative in accordance with another embodiment of the invention, in which projecting elements are spirally displaced;
    [0024] Figure 8 is a simplified illustration of an endoscopic glove constructed and operative in accordance with another embodiment of the invention, wherein the distal projecting elements are secured in a complete circular ring;
    [0025] Figure 9 is a simplified illustration of an endoscopic glove constructed and operative in accordance with another embodiment of the invention, wherein there are two sets of projection element layers; and
    [0026] Figure 10 is a simplified illustration of an endoscopic sleeve constructed and operative in accordance with another embodiment of the invention, wherein a tubular member is freely rotatable about the endoscope. DETAILED DESCRIPTION
    [0027] Reference is now made to Figure 1, which illustrates an endoscopic sleeve 10, constructed and operative in accordance with an embodiment of the invention, mounted on an endoscope 9 and inserted into a body lumen 8, such as, but not limited to, , the colon or other parts of the GI tract or other body lumens. The endoscope 9 has one or more image capture devices 7 for visualizing the body lumen and working lumens 6 (such as for introducing tools for collecting tissue samples, or for irrigation or suction, etc.), as is well known. in the technique.
    [0028] The sleeve 10 is arranged to mount over the distal end of the endoscope shaft 9 so as to encircle (or partially encircle) and extend along at least a distal portion or tip region of the endoscope shaft.
    [0029] In a non-limiting embodiment of the invention, the endoscopic sleeve 10 includes a tubular element 12 from which several spaced-apart projecting elements 14 extend. The projecting elements 14 are bendable to the proximal and distal directions of tubular element 12. will be explained here below, the projecting elements 14 are more bendable in the proximal direction than in the distal direction. In the illustrated embodiment, the projecting elements 14 are complete rings or partial rings, and are generally initially perpendicular to the tube element 12.
    [0030] All glove components 10 are constructed of a suitable biocompatible material so that they are flexible, resilient and deformable. Examples of suitable materials include, but are not limited to, polymers, elastomers and rubbers, such as polyurethane, natural rubber, silicone and silicone elastomeric materials. The material is preferably transparent to be able to hold the fabric and still allow visualization.
    [0031] Tubular element 12 and projecting elements 14 can be made of the same material or different materials. Some of the design elements 14 may be made of different materials than other design elements 14.
    [0032] As seen in Figure 5, the distal and proximal portions of tubular element 12 may have seals 13, such as O-rings. Seals 13 help tubular element 12 slide out of the endoscope by preventing fluids from coating the endoscope. outer periphery of tubular member 12. Tubular member 12 may also be provided with elongated, longitudinal reinforcing ribs 11 which maintain the structural integrity of member 12 as it is slid over the endoscope end. In other words, the ribs 11 prevent element 2 from twisting or otherwise deforming, which would make it difficult to slide element 2 over the endoscope.
    [0033] Reference is now made to Figure 2A, which illustrates the endoscope sleeve 10 and endoscope 9 are moved proximally (such as during retraction or during reciprocating movement of the endoscope) in the body lumen 8, as indicated by the arrow 17. During proximal movement of the endoscope into the body lumen 8, as indicated by arrow 17. During proximal movement of the endoscope into the body lumen, projecting elements 14 project far enough away from the tubular element 12 to contact and unfold folds of tissue in body 8 lumen for improved endoscopic visualization of the folds.
    [0034] Reference is now made to Figures 3A-3C, which illustrate an endoscopic glove 20 constructed and operative in accordance with an embodiment of the invention. In the illustrated embodiment, each of the projecting elements 14 has a root portion 22 extending from the tubular element 12 and a tissue interface portion 24 extending outwardly from the root portion 22. The root portion 22 is thinner than the tissue interface part 24 and is displaced proximally from a centerline 25 of the tissue interface part 24. As is seen by comparing Figures 3B and 3C, the bending of the projecting elements 14 in the proximal direction is not limited (figure 3B); however, bending in the distal direction is limited by the tissue interface portion 24 resting against the tubular member 12 (Figure 3C).
    [0035] This structure can be used for rings, partial rings, and any other type of designed element (such as the embodiment of figure 4). One of the advantages of this structure is that it provides little or no resistance to inserting the endoscope into the body lumen, but by retracting the endoscope proximally, it provides greater resistance to endoscope movement which opens the tissue folds, centers the endoscope, and improves imaging of the internal structure of the body lumen during endoscope retrieval. Projecting elements 14 diverge and extend from tubular element 12 so as to gently contact or grip the inner surface of the body lumen. Consequently, the force (i.e. the insertion force) required to bend the projecting elements 14 to the proximal direction is less than the force (i.e. the extraction force) required to bend the projecting elements 14 to the distal direction. The outer periphery of the projecting elements 14 decreases as the pulling force increases.
    [0036] The fabric interfacing part may have a domed or roughened surface 27 (an example is shown in Figure 2B) for improved engagement with fabric folds. Some of the projecting elements 32 may have a thicker base 29 that joins the tubular element 12, which tapers in a direction away from the tubular element 12 (an example is shown in Figure 2A).
    [0037] Reference is now made to Figure 4, which is a simplified illustration of an endoscopic glove 30 constructed and operative in accordance with another embodiment of the invention. In this embodiment, the projecting elements 32 are distinct wings which, as with the other embodiments of the invention, are more bendable in the proximal direction than in the distal direction. The wings 32 are spaced from one another by spaces 34 around a periphery of the tubular member 12.
    [0038] There are sets of projecting elements 32, each set axially spaced from one another (along the longitudinal length of the tubular element 12). As seen in the illustrated embodiment, one or more of the assemblies can have distinct wings and one or more of the assemblies can be a full or partial ring (eg, the most proximal projecting element). Continuing proximally along the length of the tubular element 12, the sets of projecting elements 32 are gradually larger in a radial direction extending outward from the tubular element 12 (i.e., the elements 32 protrude more radially as one proceeds further along the length of the tubular element 12). proximal set so that the most distal set protrudes the least and the most proximal set protrudes the most).
    [0039] In one embodiment, spaces 34 of a set of projecting elements 32 are angularly displaced in a circumferential direction from spaces 34 of an adjacent set of projecting elements 32. The most proximal set of projecting elements 32 is prevented from curving in the distal direction contacting the most distal set of projecting elements 32. For example, the most proximal set of projecting elements 32 includes a contact part 36 arranged to abut against the most distal set of projecting elements 32. The contact part 36 is wider than the space 34 between projecting elements 32 of the most distal set of projecting elements 32.
    [0040] This structure provides strong bending resistance when pulling the endoscope proximally backwards, because the layer of the proximal projection elements of larger diameter and contacts the more distal, adjacent layer that is of a smaller diameter, thus increasing the resistance. the extraction force that pulls the endoscope proximally backwards. The outside diameter of the projecting elements 32 decreases as the pulling force increases. The proximal wings 32 can have a thicker or wider midsection (contact part 36), so that when the wings begin to curve, they contact the more distal wings, which increases the overall bending resistance when pulling the endoscope away from proximal mode. In contrast, when inserting the scope in the distal direction, the larger diameter proximal layer curves in the proximal direction, resting on any other layer, and then the more distal, smaller layer also curves proximally; there is no build-up of flexural strength.
    [0041] Reference is now made to Figures 6A-6B which illustrate an endoscopic glove 40 constructed and operative in accordance with another embodiment of the invention. In this embodiment, the projecting elements 42 are distinct wings, and the most proximal chamber of the projection elements 42P includes a central radial beam 43 (contact part 43) that effectively thickens the central part of the projection element.
    [0042] There are sets of projecting elements 42, each set axially spaced from one another (along the longitudinal length of the tubular element 12). As seen in the illustrated embodiment, sets can have distinct wings. Continuing proximally along the length of the tubular element 12, the sets of projecting elements 42 are gradually larger in a radial direction extending outward from the tubular element 12 (i.e., the elements 42 protrude more radially as a progresses proximally, such that the most distal set overlaps the least, and the most proximal set overlaps the most).
    [0043] Spaces 44 of a set of projecting elements 42 are angularly deflected in a circumferential direction from spaces 44 of an adjacent set of projecting elements 42. The most proximal set of projecting elements 42P is prevented from bending to the distal direction by the beam 43 filling (and preferably overlapping) the space 44 between the projecting elements 42D of the most distal layer and of smaller diameter, so that the most proximal set of projecting elements 42P contacts the most distal set of projecting elements 42D. This accumulative structure has a stronger bending resistance when pulling the endoscope back proximally.
    [0044] Reference is now made to Figure 7, which illustrates an endoscopic glove 70 constructed and operative in accordance with another embodiment of the invention. In this embodiment, the projecting elements 72 are spirally or sporadically displaced, that is, they are arranged in a spiral shape around the tubular element 12, starting from its distal section to its proximal section, spirally displaced projection elements 72 can allow easier insertion and removal of the body lumen scope.
    [0045] Reference is now made to Figure 8, which illustrates an endoscopic glove 50 constructed and operative in accordance with another embodiment of the invention. In this embodiment, the distal projecting elements 52 are secured in a completely circular ring 53, which is a more stable structure and has greater flexural strength for the proximal projection elements 54 by bending and contacting the distal projection elements 52, the proximal projection elements 54 are distinct wings.
    [0046] Some of the projection elements 54 may be smaller in diameter than others to allow easy rotation or inversion of the elements 54 from flexing backwards during endoscope insertion, flexing backwards during endoscope extraction. A very thin flexible film (made of the same material) can connect the projection elements 54 to support the inversion of the larger projection elements 54 after the smaller elements 54 have been inverted.
    [0047] Reference is now made to Figure 9, which illustrates an endoscopic glove 60 constructed and operative in accordance with another embodiment of the invention. The sleeve 60 is similar to the sleeve 50, except that the sleeve 60 includes two sets of projection element layers, each set including distal projecting elements 52 attached to the ring 53 and proximal projection elements 54. from the other by a longitudinal space 55. This space may be sized to correspond with a tissue fold, such as a colonic fold, so that when the fold is released from one layer of the projection elements, the other can still grip the next fold, thereby providing continuous stretching of the colon.
    [0048] Another option of the invention is shown in dashed lines in Figure 9. A screen 57 can be formed between projecting elements, which ensures that all projecting elements flex together (preventing the situation where one element may flex when opposite an adjacent one). that does not flex). Projected elements can also be of various sizes and shapes.
    [0049] Reference is now made to Figure 10, which illustrates an endoscopic glove 80 constructed and operative in accordance with another embodiment of the invention. In this embodiment, a tubular member 82 is rotatably supported by two bearing rings 84. In this manner, the tubular member 82 is free to rotate around the endoscope, but is restricted from moving axially by the rings 84. The tubular member 82 includes stops 86 arranged around the central axis of element 82, typically, but not necessarily, corresponding to the position and number of projection elements 88. If tubular element 82 is rotated so that stops 86 are in front of the projection elements projection 88, then stops 86 prevent easy bending of projection elements 88, providing high bending strength. If the tubular element 82 is rotated so that the stops 86 are not facing the projection elements 88, then the projection elements 88 can flex much more easily. Thus, the user can rotate the tubular element 82 to modify the flexural strength of projecting elements 88.
    权利要求:
    Claims (10)
    [0001]
    1. Device comprising: an endoscopic sleeve (10) comprising a tubular element (12) from which a plurality of spaced projecting elements (32,42,52,54) extends, said projecting elements (32,42,52) .54) being bendable towards both the proximal and distal directions of said tubular element (12), and being configured so that an insertion force required to flex said projecting elements (32,42,52,54) towards to the proximal direction is less than an extraction force required to flex said projecting elements (32,42,52,54) towards the distal direction and projecting elements being configured such that an outer periphery of said projecting elements (32, 42,52,54) decreases as the extraction force increases; wherein said projecting elements (32,42,52,54) comprise sets of projecting elements (32, 42, 52, 54) each set axially spaced from one another; characterized in that adjacent sets of projecting elements comprise a more proximal set of projecting elements (32, 42P, 54) and a more distal set of projecting elements (32, 42D, 52), and the most proximal set of projecting elements ( 32, 42P, 54) is prevented from curving towards said distal direction by abutting against the most distal set of projecting elements (32, 42D, 52).
    [0002]
    2. Device according to claim 1, characterized in that said projected elements (32, 42, 52, 54) are more bendable in the proximal direction than in the distal direction.
    [0003]
    3. Device according to claim 1, characterized in that said projected elements ((32, 42, 52, 54) comprise at least partial rings.
    [0004]
    4. Device according to claim 1, characterized in that said projecting elements (32, 42, 52, 54) comprise distinct wings spaced from each other by spaces (44) around a periphery of said tubular element (12).
    [0005]
    5. Device according to claim 1, characterized in that the spaces (44) of a set of said projected elements (42) are angularly displaced in a circumferential direction from the spaces (44) of an adjacent set of projected elements. (42).
    [0006]
    6. Device according to claim 1, characterized in that the most proximal set of projecting elements (32) comprises a contact part (36) arranged to contact the most distal set of projecting elements (32), said contact portion (36) being wider than the space (34) between the projecting elements (32) of the most distal set of projecting elements (32).
    [0007]
    7. Device according to claim 1, characterized in that said projecting elements (32, 42, 52, 54) have a thicker base joining said tubular element (12) that tapers in a direction away from said tubular element (12).
    [0008]
    8. Device according to claim 1, characterized in that the distal and proximal parts of said tubular element (12) comprise seals (13).
    [0009]
    9. Device according to claim 1, characterized in that said tubular element (12) comprises longitudinal, elongated reinforcing ribs (11).
    [0010]
    10. Device according to claim 1, characterized in that a screen (57) is formed between two of said projected elements (52).
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    同族专利:
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2020-07-21| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-11-16| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2022-01-04| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 06/06/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201361761781P| true| 2013-02-07|2013-02-07|
    US61/761,781|2013-02-07|
    US201361822451P| true| 2013-05-13|2013-05-13|
    US61/822,451|2013-05-13|
    PCT/US2013/044407|WO2014123563A1|2013-02-07|2013-06-06|Endoscopic sleeve|
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