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WO2025032385A1 - Endoscope flexible - Google Patents

Endoscope flexible Download PDF

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Publication number
WO2025032385A1
WO2025032385A1 PCT/IB2024/054492 IB2024054492W WO2025032385A1 WO 2025032385 A1 WO2025032385 A1 WO 2025032385A1 IB 2024054492 W IB2024054492 W IB 2024054492W WO 2025032385 A1 WO2025032385 A1 WO 2025032385A1
Authority
WO
WIPO (PCT)
Prior art keywords
channel
catheter
mode
flexible endoscope
catheter body
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2024/054492
Other languages
English (en)
Inventor
Pawan Kumar Gupta
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2025032385A1 publication Critical patent/WO2025032385A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/015—Control of fluid supply or evacuation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00131—Accessories for endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00131—Accessories for endoscopes
    • A61B1/00137—End pieces at either end of the endoscope, e.g. caps, seals or forceps plugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments

Definitions

  • Present disclosure in general, relates to the field of biomedical devices. Particularly, but not exclusively, the present disclosure relates to a flexible endoscope device. Further, embodiments of the present disclosure disclose a catheter of the flexible endoscope device, rendering the flexible endoscope device to be capable of collapsing, expanding and/or allowing operations such as suction, injecting, and/or blowing to be performed.
  • an endoscope device is employed for inspecting and/or analysing internal condition of a subject.
  • Such endoscope devices are, in general, insertable into the subject through an incision being performed at predetermined location, or at vents that are naturally developed or available in the subject.
  • the endoscope devices are structured to flexible, i.e., the endoscope devices are generally bendable which allow such devices to move, navigate, and actuate through openings being defined in the subject.
  • Such flexible endoscopes generally include a connector segment, a control segment, and an insertion segment.
  • the insertion segment includes an insertion tube having an opening at a distal end for contacting the subject.
  • the insertion tube includes a conduit and an imaging unit which may be integrally connectable with a deflection mechanism, where the imaging unit and the deflection mechanism along with the conduit are introducible into the subject.
  • the imaging cum deflection mechanism may include, but not limited to, a Complementary Metal Oxide Semiconductor (CMOS) image sensor, one or more Light Emitting Diode (LED), and the like.
  • CMOS Complementary Metal Oxide Semiconductor
  • LED Light Emitting Diode
  • the conduit of the flexible endoscope is configured to carry irrigation fluid and accessory instruments in the form of laser fibre, baskets & the like.
  • RIRS Retrograde Intra Renal Surgery
  • the flexible endoscope may be passed through a portion of urinary passage to the urinary bladder of the subject.
  • the flexible endoscope is then passed through ureter, terminal part of which generally has a diameter of about 2 mm to 3 mm.
  • ureter terminal part of which generally has a diameter of about 2 mm to 3 mm.
  • the insertion tube of said flexible endoscope it is required for the insertion tube of said flexible endoscope to be of the same diameter or less, in order to prevent causing any damage to tissues at the renal section of the subject.
  • the flexible endoscopes currently being used for treating kidney stones by a procedure called Retrograde Intra Renal Surgery, where such endoscopes are dimensioned to range from approximately 2.5 to 3.00 mm in cross sectional diameter.
  • An access sheath is being used to facilitate passage of the flexible endoscope to the collecting section of the kidney of the subject. These access sheaths are generally more than 3 mm in diameter.
  • Several access sheaths have been designed to carry out functions of suction of dust and small kidney stone fragments after laser lithotripsy of stones during the procedure of Retrograde Intra Renal Surgery of Kidney Stones. Even small channel of conventional flexible endoscope has been used for sucking the dust.
  • a catheter of a flexible endoscope comprises a catheter body, which is defined by a proximal end and a distal end.
  • the proximal end being connectable to an umbilical section of the flexible endoscope, and the distal end being defined with a deflectable portion.
  • the catheter body is defined with a first channel, a second channel and a third channel.
  • the first channel accommodates at least one of an optical system and a deflection mechanism to deflect the deflectable portion, and the second and third channel being structured to expand on operation.
  • the catheter includes a covering, which is configured to cover substantial portion of the first channel of the catheter body.
  • the inner surface of the first channel of catheter is depressed and is concave to accommodate the second & third channels of catheter body.
  • the catheter also includes an actuating member, which is introducible into the second channel of the catheter body. The actuating member is operable to selectively expand the second channel, wherein the second channel, upon expansion, is operable in a plurality of modes, and one of such plurality of modes of the second channel is configured to allow a suction operation in the second channel.
  • the third channel is used for the purpose of irrigation.
  • Figure 1 illustrates a flexible endoscope including a catheter being capable of operable in a plurality of modes, and one of such plurality of modes of the catheter being configured to allow a suction operation in the flexible endoscope, in accordance with the present disclosure.
  • Figure 2 illustrates an actuation member including a plurality of sheaths for the flexible endoscope of Figure 1, in accordance with the present disclosure.
  • Figures 3a and 3b illustrate a first mode and a second mode the plurality of modes, respectively, of the flexible endoscope, in accordance with the present disclosure.
  • Figure 4 illustrates a sectional view of a portion of catheter of the flexible endoscope capable of accommodating the actuation member with the plurality of sheaths, in accordance with an embodiment of the present disclosure.
  • the term ‘detachable’ refers to portion of the flexible endoscope being able to be spilt into multiple parts, where such parts may be temporarily fixed and then introduced into opening in the subject. Alternatively, the parts may form the flexible endoscope on inserting into the subject separately or during insertion into the openings of the subject.
  • the term ‘suction’ refers to action of creating negative pressure at a tip portion of the flexible endoscope or along entire length of the catheter and in-tum that of the flexible endoscope. Such negative pressure may be produced based on connecting a suction creation device such as pump or vacuum tube or any other element/component which is either integral part of the catheter or that of the flexible endoscope or which may be externally coupled thereto. Alternatively, said term may be interchangeable with drawing process, discharging, dispensing, retrieving and/or removal process. The term ‘suction’ may also be collectively used for drawing process, discharging, dispensing, retrieving and/or removal process. [21] In an embodiment, the term ‘deformable material’ may be referred to as a material which is capable of bending elastically and not produce serrations or sharp edges on subjecting to such bending.
  • the term “ancillary device” may be referred to as devices which may be capable of being introduced into a catheter of the flexible endoscope or operating in conjunction with the flexible endoscope for regulating actions to be performed there through.
  • the ancillary devices of the flexible endoscope being an ureteroscope or RIRS instrument, may be including a basket or carrier configured to carry stone fragments from the subject, or a laser cable capable of breaking stones, or an element capable of inducing suction through the catheter for selectively regulating pressure within the flexible endoscope and in-turn portion of the subject for retrieving at least the fragments or dust at location of ureterorenoscopy or intrarenal examination.
  • the catheter and the flexible endoscope as disclosed in the present disclosure may be used in any flexible endoscope, such as, but not limited to, gastroscope, enteroscope, laryngoscope, bronchoscope, angioscope, RIRS instrument, and the like. Particularly, some of the embodiments may be illustrated and described for ureteroreno scope.
  • FIG. 1 illustrates a flexible endoscope (100) (hereinafter also interchangeably referred to as the ‘device (100)’) and a catheter (50) of said flexible endoscope (100) in accordance with an embodiment of the present disclosure.
  • the endoscope (100) includes a handle (4) at a proximal end (A) for being clasped, regulated and operated by an operator.
  • the handle (4) may be structured to include and conceal operational mechanism such as displacement means (not seen in Figures) based on which the flexible endoscope (100) may be operable by the operator.
  • the flexible endoscope (100) or the handle (4) includes a control of deflection mechanism (4a) (as seen in the figure) defined on the handle (4) and away from the operator’s grip, where such deflection mechanism may be operable by the displacement means being included in the handle (4). Due to such configuration, manoeuvring of the flexible endoscope (100) towards or within the subject or field of interest for inspection in the subject may be performed. Additionally, the deflection mechanism is connectable to a deflectable portion (6) of the catheter (50) at an end (B) of the flexible endoscope (100).
  • the deflectable portion (6) is configured to be introducible into at least the field of interest and adapted to be in contact with the subject (not shown in the figures), where orientation of the deflectable portion (6) being controlled and selectively regulated by the operator through the deflection mechanism at the handle (4).
  • the flexible endoscope (100) includes an umbilical portion (5) communicatively coupled to the control of deflection mechanism (4a) and the handle (4).
  • the umbilical portion (5) is configured to connect the catheter (50) with the handle (4), where such connection may be configured to establish operation of the deflectable portion (6) based on regulation of control of the deflection mechanism (4a) at the handle (4) or at the proximal end of the flexible endoscope (100).
  • the catheter (50) may be integrally formed with the umbilical portion (5) of the device (100).
  • the umbilical portion (5) may also provide access to one or more external ports, for irrigation and for inserting accessory instruments with or without irrigation fluid.
  • the catheter body and the catheter (50) have been referred with same numeral 50 for sake of brevity in figures.
  • the catheter body is defined with a first channel (1), a second channel (2) and a third channel (3).
  • the first channel (1) accommodates at least one of an optical system and the deflection mechanism (not seen in the figure) which are capable of deflecting the deflectable portion (6) of the catheter (50) upon operation of the control of the deflection mechanism (4a).
  • dimension of the first channel (1) is substantially constant during operation of the flexible endoscope (100) and may have minimal to no variation in such dimension of the first channel (1).
  • the second channel (2) is structured to expand on operation, in comparison to that of the first channel (1). Also, expansion of the second channel (2) may be selective and may depend on mode in which the flexible endoscope (100) is being operated.
  • the flexible endoscope (100) includes an actuating member (18), introducible into the second channel (2) of the catheter body, as seen in conjunction between figures 1, 3a and 3b.
  • the actuating member (18) may be introducible about an introduction passage (not seen in figures) defined in at least one of the umbilical portion (5) or the catheter body, for selectively expanding the second channel (2).
  • the actuating member (18) is introduced through an outer port [can be referred to as numeral 9]being defined in either of the umbilical portion (5) or the catheter body (50), to form the second channel (2).
  • the second channel (2) (referred to as numeral 2 in Figure 1, 3a & 3b), upon expansion, is operable in a plurality of modes, and one of such plurality of modes of the second channel (2) is configured to allow a suction operation in the second channel (2).
  • the actuating member (18) of the catheter (50) includes a plurality of sheaths (16).
  • the actuating member (18) is connectable to an actuation mechanism (19) [as seen in Figure 1, 3 a and 3b], to operate at least one sheath (16) of the plurality of sheaths (16), to selectively expand the second channel (2) between the first mode and the second mode.
  • the at least one sheath (16) of the plurality of sheaths includes a film (15) which is expandable and collapsible for operation of the second channel (2) between the first mode and the second mode.
  • the sheath (16) further includes a support element (14) being connectable to at least a side portion of the film (15).
  • the film (15) which is further supported by the strips (13, 13a, 13b) and a wire (13c) on its undersurface so that the film (15) is deflectable and/or deformable during operation of the catheter (50) between the first mode and the second mode.
  • the support element(14) is displaceable by the actuating mechanism (19) to operate the film (15) between a first mode (seen in Figure 3a) and the second mode (seen in Figure 3b), correspondingly to operate the second channel (2) between the first mode and the second mode (seen as expanded portion of the second channel being depicted in Figure 3b).
  • the actuating member (18) of the catheter (50) including the plurality of sheaths (16) are detachably connectable to at least one edge portion in a groove (11, I la, 11b) defined in the first channel (1) of the catheter body, as seen in Figure 4.
  • the at least one sheath (16) of the plurality of sheaths includes a first strip member (13), which is positioned along a portion of the film (15) in a first orientation.
  • the first strip member (13) being displaceable along movement of the deflectable portion (6) of the catheter (50).
  • the at least one sheath (16) of the plurality of sheaths (16) includes a second strip member (13a) seen in Figure 3a and 3b, positioned at an end of the film (15).
  • thickness of the second strip member (13a) is selected to be greater than the thickness of the first strip member (13), in order to reduce dimension of the second channel at the tip portion (7), as depicted with numeral 2 to a dimension as being depicted with numeral 2a, in the second mode, for the suction operation of the catheter (50).
  • the diameter of the second channel (2) at the tip is smaller than the channel itself, this will prevent the dust, debris & small fragments of stone from getting stuck in the second channel (2).
  • the dimension of the second strip (13a) is greater than the first strip (13) and that the tip portion (7) of the catheter (50) being thick, movement of the deflectable portion (6) of the catheter (50) is rendered to become easy in the field of interest.
  • the first channel of the catheter (50) & thereof, the flexible endoscope (100) includes a covering (20) which covers entire outer surface of the first channel (l).
  • the catheter (50) as a whole including first channel (1), the second channel (2) and the third channel (3) may be covered by a hydrophilic coating which facilitates introduction of the catheter (50).
  • the covering (20) may be configured to define the third channel (3), when the endoscope (100) is operable to the second mode, such that the sheath (16) of the plurality of sheaths (16) is expandable and collapsible for operation of the second channel (2) between the first mode and the second mode.
  • the sheath (16) is displaceable by the support element (14), where such support element (14) on being operable by the actuating mechanism (19) is configured to relatively and correspondingly displace (i.e., by way of twisting and/or, folding or unfolding) the sheath (16) to be in expandable and collapsible forms.
  • the support element (14) is operated (by either twisting in clockwise or anti clockwise direction) to displace the sheath (16) to expand, as seen in Figure 3b.
  • the sheath (16) is configured to define the third channel (3) for irrigation by allowing flow of the irrigation fluid from the proximal end (A) through an irrigation port (10) to the distal end (B) of the catheter (50).
  • the third channel (3) [which may be interchangeably referred to as “irrigation passage” or “the irrigation channel” (3)] is bound by covering (20) on one side, the stretchable membrane (17) on the other side, and the sheath (16) on the third side.
  • one end of the stretchable membrane (17) is connectable to at least a portion of the second channel (2) or the support element (14) and another end of the stretchable membrane (17), opposite to the one end, is connectable to at least one of the covering (20) or portion of the first channel (1).
  • one end of the stretchable membrane (17) being connectable to at least one edge of first channel (1) or with a sealing element (12b) at one side and other end of the membrane (17), opposite to the one end, being connectable to at least one of the covering (15) or support element (14) or portion of the second channel (2).
  • the first channel (1) or the sealing member (12b) or groove (11b) and the stretchable membrane (17) is configured to form the third channel (3) between the stretchable membrane (17), one of the plurality of sheaths (16) and the covering (20) of the first channel (1), to allow flow of the irrigation fluid along the catheter body, in the first mode and the second mode of the second channel (2) and in turn the catheter (50).
  • Atleast one of the plurality of sheaths (16), the stretchable membrane (17) and edge of the first channel (1) may be externally fused and/or integrally formed. In an embodiment, atleast one of the plurality of sheaths, the stretchable membrane (17) and the edge of the first channel (1) may be fused by at least one of adhesive boding, press-fitting, layup process, snap-fitting, and amongst others.
  • the stretchable membrane (17) may be made of rubber or any polymeric or fibrous material which may be flexible and the stretchable membrane (17) being capable of accommodating one of the sheath (16) of the plurality of sheaths (16) along with being displaceable for operating the catheter (50) between the first mode and the second mode.
  • the first strip members (13) may be positioned along longitudinal direction or lateral direction of the device (100). Alternatively, the first strip members (13) may be positioned on both longitudinal direction and lateral direction of the device (100). In an embodiment, the first strip members (13) may be positioned at an angle relative to the longitudinal direction of the device (100), where such positioning of the first strip members (13) may allow inflating of the device (100) upon rotation in one direction, while the device (100) may collapse (i.e., reduce in dimension) upon rotation of the first strip members (13) in another direction, opposite to the one direction. Also, the first strip members (13) may be defined with one or more protuberances (not shown in figures) that may resemble screw auger for drawing and retrieving fluid or solid residue along the device (100) and in-turn from the subject.
  • the sheath (16) facilitates in selective inflation of the inflatable material upon supplying the irrigation fluid.
  • the catheter (50) includes an inner surface (IS) being defined with a depressed and concave profile. This will increase the size of the suction channel.
  • the first sealing element (12), the second sealing element (12a) and a third sealing element (12b) is aligned and attached to the grooves (11, I la, 11b) of the first channel (1), to detachably attach and introduce the actuating member (18) and the stretchable membrane (17) relative to the catheter body, and in-turn the catheter (50).
  • the actuating member (18) and the stretchable membrane (17) is then slid along the grooves (11, I la, 11b) to introduce the actuating member (18) and the stretchable membrane (17) for operating the catheter (50) in the plurality of modes.
  • the first strip members (13) along with the central wire (13c) extend several centimetres proximally beyond the deflectable portion and then followed by continuous strip (13b). This will have more stiffness and better control of the catheter during operation.
  • second channel (2) together with third channel (3) are detachable from first channel (1) & the umbilical part (5) & therefore from the Catheter (50) & flexible endoscope (100).
  • channel 2 and 3 can be of single use while the rest of scope can be multiple use.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Optics & Photonics (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Endoscopes (AREA)

Abstract

L'invention concerne un cathéter (50) d'endoscope flexible (100). Le cathéter (50) comprend un corps de cathéter, défini par une extrémité proximale et une extrémité distale. L'extrémité proximale peut être raccordée à une section ombilicale (5) de l'endoscope flexible (100), et l'extrémité distale est définie avec une partie de béquillage. Le corps de cathéter est défini par un premier canal (1), un deuxième canal (2) et un troisième canal (3). Le premier canal (1) reçoit un système optique et/ou un mécanisme de déviation pour dévier la partie de béquillage, le deuxième canal (2) et le troisième canal (3) étant structurés pour se dilater lors du fonctionnement. Le cathéter (50) comprend un élément d'actionnement (18), pouvant être introduit dans le second canal (2) du corps de cathéter. L'élément d'actionnement (18) peut fonctionner pour dilater sélectivement le second canal (2). Lors de son expansion, le second canal (2) peut fonctionner selon plusieurs modes, l'un de ces modes étant conçu pour permettre une opération d'aspiration dans le second canal (2).
PCT/IB2024/054492 2023-08-09 2024-05-08 Endoscope flexible Pending WO2025032385A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202311053384 2023-08-09
IN202311053384 2023-08-09

Publications (1)

Publication Number Publication Date
WO2025032385A1 true WO2025032385A1 (fr) 2025-02-13

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5025778A (en) * 1990-03-26 1991-06-25 Opielab, Inc. Endoscope with potential channels and method of using the same
US20170035277A1 (en) * 2015-08-07 2017-02-09 Robert C. Kucharski Endoscope with Variable Profile Tip
US9918728B2 (en) * 2014-04-23 2018-03-20 Gyrus Acmi, Inc. Stone fragment suction device
CN114073568A (zh) * 2020-08-12 2022-02-22 上海康路联医疗科技有限公司 扩张鞘组件
JP2023509596A (ja) * 2020-01-08 2023-03-09 チョウ，シン 体腔拡張装置付きの可視化診療システム

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5025778A (en) * 1990-03-26 1991-06-25 Opielab, Inc. Endoscope with potential channels and method of using the same
US9918728B2 (en) * 2014-04-23 2018-03-20 Gyrus Acmi, Inc. Stone fragment suction device
US20170035277A1 (en) * 2015-08-07 2017-02-09 Robert C. Kucharski Endoscope with Variable Profile Tip
JP2023509596A (ja) * 2020-01-08 2023-03-09 チョウ，シン 体腔拡張装置付きの可視化診療システム
CN114073568A (zh) * 2020-08-12 2022-02-22 上海康路联医疗科技有限公司 扩张鞘组件

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