WO2018187235A1 - Spéculum vidéoscopique à profil bas doté d'un orifice de travail - Google Patents

Spéculum vidéoscopique à profil bas doté d'un orifice de travail Download PDF

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Publication number
WO2018187235A1
WO2018187235A1 PCT/US2018/025740 US2018025740W WO2018187235A1 WO 2018187235 A1 WO2018187235 A1 WO 2018187235A1 US 2018025740 W US2018025740 W US 2018025740W WO 2018187235 A1 WO2018187235 A1 WO 2018187235A1
Authority
WO
WIPO (PCT)
Prior art keywords
lumen
insert
elongate body
distal
elongate
Prior art date
Application number
PCT/US2018/025740
Other languages
English (en)
Inventor
John Langell
Laura J. GARDNER
Annie FONNESBECK
Original Assignee
John Langell
Gardner Laura J
Fonnesbeck Annie
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 John Langell, Gardner Laura J, Fonnesbeck Annie filed Critical John Langell
Publication of WO2018187235A1 publication Critical patent/WO2018187235A1/fr

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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
    • A61B1/303—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 for the vagina, i.e. vaginoscopes
    • 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
    • A61B1/32—Devices for opening or enlarging the visual field, e.g. of a tube of the body

Definitions

  • the most common vaginal speculum is the two-billed speculum.
  • the two-billed speculum has two opposing bills that, while closed, are inserted into the vagina. Once inserted, the opposing bills are opened to expand the introitus and the vaginal walls. In the open position, the bills are typically slightly outwardly angled to prevent pressure from the opened vaginal tissue from ejecting the device. An opening is formed between the two opened bills that allows a healthcare professional to perform a visual inspection or to gather a sample.
  • Another conventional speculum device is a balloon speculum, which has a similar function as the two-billed speculum.
  • the balloon speculum is interested into the vagina, and an inflatable element is inflated to expand the tissues surrounding the speculum.
  • Such conventional specula have several limitations. Use of these specula is often associated with physical discomfort and sometimes even pain, especially during insertion and expansion. In many instances, for example, the opposing bills of a two-billed speculum can pinch surrounding vaginal tissue or other nearby tissues. These issues may be exacerbated when examination is performed on an obese individual.
  • vaginal specula that can improve gynecological care by reducing patient pain and discomfort, reducing patient psychological stress, and/or improving access to effective gynecological screening.
  • a speculum device configured to enable effective gynecological examination or surgery while minimizing the required expansion of the vaginal introitus.
  • a speculum device includes an elongate body having a proximal end and a distal end.
  • a tapering section is disposed at a distal section of the elongate body, and tapers from a larger size at an intermediate point to a smaller size at the distal end.
  • the elongate body also includes a first lumen and a second lumen.
  • the first lumen extends from the proximal end to the distal end of the device, and may be open or closed at the distal end.
  • the first lumen is configured in size and shape to receive a scope device for visualizing tissue at or near the distal end of the elongate member.
  • a distal end of the scope device may be inserted into the first lumen to a position at or near the distal end of the elongate member to enable visualization of nearby tissues.
  • the elongate body also includes a second lumen which extends from the proximal end of the elongate body to the intermediate point where the tapering section begins.
  • the second lumen opens to a distal port at this point near the beginning of the tapering portion.
  • the second lumen may be utilized for collecting a sample and/or delivering a medicament, for example.
  • the speculum device also includes an insert which is configured in size and shape so at least a portion is received within the second lumen.
  • the insert is selectively adjustable between a closed position that blocks or seals the second lumen and an open position that allows access to the second lumen.
  • the insert may be removed from the second lumen by proximally pulling the insert out of the proximal opening of the second lumen.
  • the insert may be selectively rotated within an annular space of the elongate member to move it out of the way of the proximal and distal openings of the second lumen.
  • the insert may include a distal wedge shaped with a tapered profile.
  • the distal wedge passes out of and distally beyond the distal opening (i.e., port) of the second lumen when the insert is in the closed position.
  • the tapered profile of the wedge may be configured to match or substantially match the profile of the tapering section, so that the combination of the wedge and the tapering section form an overall tapered shape when the device is in the closed position. This beneficially allows for atraumatic insertion of the device while minimizing the potential for catching or pinching surrounding tissue and while minimizing the necessary expansion of the vaginal introitus.
  • Embodiments described herein beneficially enable effective pelvic examination while minimizing patient discomfort and pain.
  • the features of the embodiments described herein allow for use while the patient is in a more comfortable position, such as while lying on an examination table, and allows for appropriate patient-provider interaction during a procedure.
  • the reduced degree of vaginal introitus expansion and the more natural patient-provider interaction enabled by the disclosed specula can also beneficially reduce psychological stress associated with conventional pelvic exams and similar procedures.
  • the benefits associated with the disclosed specula may encourage more women to undergo an examination or to do so more regularly.
  • the disclosed embodiments are easy to use and provide features that enable use in remote environments.
  • a speculum device as disclosed herein could readily be utilized by those in environments with substandard healthcare infrastructure, and the obtained imagery could be analyzed off-site, thereby bringing gynecological care to a wider swath of women.
  • Figures 1 and 2 illustrate isometric views of an exemplary vaginal speculum device
  • Figure 3 illustrates the speculum device of Figures 1 and 2 with a scope device which may be used in conjunction with the speculum device by inserting the scope device into a first lumen of the speculum device;
  • Figure 4 is an exploded view of the speculum device of Figures 1 through 3, showing an elongate body and a separate insert section configured to be selectively inserted into a second lumen of the elongate body;
  • Figures 5 and 6 illustrate side views of the elongate body, with Figure 6 shown in longitudinal cross-section to better illustrate the first lumen and second lumen;
  • Figures 7 and 8 illustrate an alternative embodiment of a vaginal speculum device wherein the insert section is configured to be selectively moved between an open position and a closed position by rotation about the first lumen;
  • Figure 9 illustrates another embodiment of a vaginal speculum device having one or more linkage elements and one or more restraining elements which may be attached to a patient or to an object near the patient to assist in maintaining the device within the patient's vaginal canal;
  • Figure 10 illustrates another embodiment of a vaginal speculum device having a closed distal end on the first lumen.
  • FIGS 1 and 2 show isometric views of an exemplary vaginal speculum device 100.
  • the illustrated speculum device 100 includes an elongate body 102 extending between a proximal end 132 and a distal end 134.
  • a healthcare provider inserts the distal end 134 of the speculum device 100 into the patient's vaginal canal while holding the elongate body 102 in a desired fashion, typically somewhere closer to the proximal end 132.
  • the speculum device 102 enables a healthcare provider to perform a pelvic examination without the need to spread the introitus to the same degree as with conventional specula. This beneficially reduces the risk of pain and discomfort to the patient.
  • the elongate body 102 also includes a tapering section 110 located near the distal end 134 of the device.
  • the shape of the tapering section 110 gives the device an "aerodynamic" profile and beneficially allows for gentle and smooth insertion of the device into the vaginal canal.
  • the tapering section 110 begins at an intermediate point 116 and extends to the distal end 134 of the device, with the size (e.g., diameter) of the elongate body 102 being greater at the intermediate point 116 than at the distal end 134.
  • the angular change of the tapering portion 110 need not be uniform in all directions, though in some embodiments it may be.
  • the bottom surface of the device remains substantially flat (see side views in Figures 5 and 6) even though other portions are tapered to the smaller size at the distal end.
  • the tapering section 110 of the elongate member 102 comprises the distal-most 10% to 30% of the elongate member 102, though other proportions may be utilized according to particular application needs.
  • the diameter of the elongate member 102 at the distal end 134 is about 25% to about 75%, or more preferably about 40% to about 60%, of a diameter of the elongate member 102 at the intermediate point 116 before tapering begins.
  • the tapering angle may have an angle of decline of about 10 to 45 degrees. Structures within these dimensional ranges beneficially balance the desire to maintain sufficient size at the distal end for fitting a scope device with the desire to have a smooth taper for more comfortable insertion.
  • the elongate body 102 includes a first lumen 112 that extends through the length of the elongate body 102.
  • the various lumen of the device may synonymously be referred to herein as "shafts.”
  • the first lumen 1 12 is configured in size and shape to receive a scope device to allow for visualization of targeted vaginal or cervical tissues during use of the speculum device 100.
  • the first lumen 112 is open at the distal end 134.
  • Alternative embodiments may include a first lumen 112 with a closed distal end 134 (see, e.g., Figure 10), such as one that extends to a closed convex point.
  • the speculum device 100 also includes an insert 104 (which also may be referred to herein as a "plug” or "plug element”).
  • the insert 104 is shown here in a closed position with a portion of the insert 104 disposed within a second lumen 114 of the device (see, e.g., Figures 4 through 6 for better views of the second lumen 114).
  • the insert includes an elongate section 120 (see Figure 4) that extends through the second lumen 114.
  • the insert 104 is sized so that when it is in the closed position of Figures 1 and 2, a distal wedge 118 extends distally beyond a distal opening of the second lumen 114 to block the distal opening.
  • the distal opening of the second lumen 114 may also be referred to herein as the port 122 of the second lumen 114 (see Figures 4 through 6).
  • the wedge 118 includes a tapered profile.
  • the tapered profile of the wedge 118 may be configured to substantially match a profile of the tapering section 110 of the elongate body 102. That is, the wedge 118 and the tapering section 110 work in conjunction with one another to form an overall tapered profile when the device is in the closed position. Typically, during insertion, the device will be in the illustrated closed position, and the combined profile of the tapering section 110 and the wedge 118 work to provide a beneficial atraumatic shape which allows for effective insertion.
  • the insert 104 seals and/or plugs the second lumen 114 to prevent the unintentional transfer of fluids, debris, or other contaminants. This beneficially maintains a more closed system, which is particularly useful where contamination may be a concern (e.g., with pregnant women).
  • the healthcare provider desires to collect a sample (e.g., for a pap smear or a biopsy) and/or deliver a medicament, the insert 104 may be removed to provide access through the open distal end of the second lumen 114.
  • the insert 104 of the illustrated speculum device 100 also includes a proximal stop 106.
  • the proximal stop 106 is sized to prevent passage into the second lumen 114 and to thereby define the limit of distal extension of the insert 104 through the second lumen 114.
  • the proximal stop 106 is also shaped to avoid blocking access to the proximal opening of the first lumen 112.
  • a grip extension 108 may also extend proximally from the proximal stop 106.
  • the grip extension 108 may be formed as a tab, ring, hook, or other structure enabling the user to grip and move/manipulate the insert 104 relative to the elongate body 102. For example, when the healthcare provider desires to remove the insert to put the device in the open position, he/she may grip the grip extension 108 and pull the insert 104 proximally until it clears the proximal opening of the second lumen 114.
  • Figure 3 illustrates an exploded view showing the speculum device 100 and a scope device 190 (i.e., camera scope) that may be utilized in conjunction with the speculum device 100.
  • the scope device 190 may be any suitable laparoscope device capable of providing visualization of tissues once delivered to the targeted tissues.
  • One preferred example is the scope device sold under the tradename "Xenoscope.”
  • the extended scope section 192 of the scope device 190 may be inserted into the first lumen 112 of the speculum device 100.
  • the first lumen 112 may include one or more detents, O-rings, tabs, gaskets, and/or other structural features for fixing the extended scope section 192 in place once inserted into the first lumen.
  • the scope device 190 may be positioned within the first lumen 112 prior to insertion of the speculum device 100 into the patient's vaginal canal.
  • the speculum device 100 may first be inserted into the patient's vaginal canal, followed by placement of the scope device 190 within the first lumen.
  • the scope device 190 may then be operated to generate light and obtain desired imagery of the targeted tissues.
  • the scope device 190 is capable of generating imagery (such as on a nearby screen), and because the combination of the speculum device 100 and the scope device 190 requires minimal manipulation or force once positioned, the system facilitates appropriate and comfortable patient-provider interaction. This can beneficially reduce psychological distress experienced by the patient.
  • the patient may be able to lie down in a comfortable position rather than be positioned in stirrups.
  • the healthcare provider will be able to maintain face to face contact with the patient during the examination while both view the imagery gathered by the scope device 190 through the functionality of the speculum device 100.
  • Figure 4 is an exploded view of the speculum device 100, showing separation of the insert 104 from the second lumen 114 of the elongate body 102.
  • the second lumen 114 may be shaped to partially surround the first lumen 112 in a crescent or semicircle shape, for example. This arrangement allows the first lumen 112 to maintain a full circular cross section to allow for insertion of the scope device 190, while conforming the second lumen 114 to the first lumen 112 to reduce the overall cross-sectional profile of the device. That is, by allowing the first lumen 112 to "nest" somewhat within the cross section of the second lumen 114, the overall diameter of the elongate body 102 may be reduced.
  • Figures 5 and 6 show side views of the elongate member 102, with Figure 6 shown in cross-section.
  • the first lumen 112 and second lumen 114 may be substantially parallel to one another.
  • the second lumen 114 opens distally to the port 122, which is located somewhat proximal of the distal opening of the first lumen 112 to allow space for the wedge 118 when the insert 104 is placed.
  • the edge surrounding the port 122 may be chamfered or beveled to minimize the risk of catching against tissue during insertion of the device.
  • FIGs 7 and 8 illustrate an alternative embodiment of a vaginal speculum device 200.
  • the speculum device 200 may include any of the features described above with respect to the speculum device 100.
  • the speculum device 200 includes an elongate body 202 and an insert 204.
  • the insert 204 is configured to be selectively rotated around the first lumen 212 to move between the closed position shown in Figure 7 to the open position shown in Figure 8.
  • the elongate body 202 includes sufficient annular space 246 around the first lumen 212 for the insert 204 to be rotated within the annular space 246 to open or close the distal port 222.
  • the proximal end of the insert 204 terminates near the proximal opening 240 of the second lumen.
  • a grip extension 242 is coupled to the proximal end of the insert 204 and extends proximally out of the proximal opening 240. By gripping the grip extension 242, the healthcare provider is able to rotate the insert 204 through the annular space 246 by rotating the grip extension 242 through proximal opening 240. Once moved to the open position shown in Figure 8, the second lumen will be open from the proximal opening 240 to the distal port 222.
  • FIG 9 illustrates another embodiment of a vaginal speculum device 300.
  • the speculum device 200 may include any of the features described above with respect to the speculum device 100 and/or 200.
  • the speculum device 300 includes an elongate body 302 and an insert 304.
  • the speculum device may also include one or more attachment points 350 located at or near the proximal end of the elongate body 302.
  • the attachment points 350 may be formed as hooks, loops, ties, or other fasteners to enable attachment to one or more linkage elements 352.
  • the linkage elements extend from a first end, which is attached to a respective attachment point 350, to a second end, which is attached to a restraint element 354.
  • the linkage elements 352 may be formed as string, liner, cord, or other such structure for mechanically coupling the attachment points 350 to the restraint elements 354.
  • the restraint elements 354 may be attached to the patient or to an object near the patient (e.g., the examination table) to maintain tension in the linkage elements 352 and thereby assist in maintaining the position of the speculum device 300 within the patient's vaginal canal.
  • the restraint elements 354 may be formed as, for example, suction cups, straps, hook and loop fastener elements, or other suitable fastening structure. Use of the restraint elements 354 and linkage elements 352 may minimize the tendency of vaginal pressure to move the speculum device 300 back out of the vaginal canal, though such a system may not be needed in all cases.
  • Figure 10 illustrates another embodiment of a vaginal speculum device 400.
  • the speculum device 200 may include any of the features described above with respect to the speculum device 100, 200, and/or 300.
  • the speculum device 400 includes an elongate member 402 and an insert 404.
  • the distal end of the device includes a closed tip 460.
  • the closed tip 460 is preferably transparent to allow proper operation of the scope device when inserted within the first lumen up to the distal tip 460.
  • the distal tip 460 may be integrally formed with the rest of the elongate body 402 or alternatively may be separately formed and attached to the elongate body 402.
  • the elongate body 402 is formed from a relatively rigid material while the distal tip 460 is formed from a more flexible material, such as a soft rubber or other flexible polymer material.
  • a measuring scale is imprinted on the distal tip such that it overlays the field of view of the scope device.
  • the measuring scale can beneficially enable measurement of examined tissues, such as cervical dilation.
  • a flexible extension (not shown) of fixed length may extend distally from the distal end of the device.
  • the flexible extension can be formed with a standard, known length to function as a baseline for making tissue measurements.
  • the elongate member may have a length of about 100 mm to about 250 mm, or more preferably a length of about 125 mm to about 200 mm.
  • the elongate member may have a diameter (at its widest point, not at its tapering section) of about 20 mm to about 40 mm.
  • the elongate member may have a wall thickness of about 0.5 mm to about 3 mm in order to provide sufficient rigidity and luminal strength while leaving sufficient luminal space.
  • the first lumen may have an inner diameter of about 6 mm to about 20 mm, or more preferably about 8 mm to about 15 mm.
  • Components of the speculum device may be made from biomedically suitable materials, including polymers such as acrylate polymers, polystyrene, polyethylene, polypropylene, polycarbonate, silicone, other suitable polymers, or combinations thereof.
  • One or more suitable metal e.g., titanium, stainless steel
  • ceramic materials may additionally or alternatively be utilized.
  • at least the elongate body 102 is substantially transparent.
  • any of the features or components related to the vaginal speculum devices 200, 300, or 400 may be combined with or substituted for features or components of the vaginal speculum device 100.

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

Abstract

L'invention concerne un dispositif de spéculum vaginal comprenant un corps allongé avec une première lumière pour recevoir un dispositif d'endoscope et une seconde lumière permettant à un utilisateur de collecter un écouvillon et/ou un échantillon. Un insert est positionné à l'intérieur de la seconde lumière et est sélectivement mobile entre une position fermée et une position ouverte. Une section distale du corps allongé comprend une section conique. L'insert comprend une cale distale qui est également effilée de telle sorte que lorsque l'insert est dans la position fermée pour fermer la seconde lumière, la conicité de la cale correspond sensiblement à la conicité de la section conique.
PCT/US2018/025740 2017-04-03 2018-04-02 Spéculum vidéoscopique à profil bas doté d'un orifice de travail WO2018187235A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762480552P 2017-04-03 2017-04-03
US62/480,552 2017-04-03

Publications (1)

Publication Number Publication Date
WO2018187235A1 true WO2018187235A1 (fr) 2018-10-11

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112535501A (zh) * 2020-12-02 2021-03-23 朱英宏 一种妇产科用宫腔取样装置

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4900306A (en) * 1988-01-15 1990-02-13 Corpak, Inc. Device for intubation of percutaneous endoscopic ostomy
US4979498A (en) * 1989-10-30 1990-12-25 Machida Incorporated Video cervicoscope system
US6086603A (en) * 1998-12-14 2000-07-11 Syntheon, Llc Luminal port device having internal and external sealing mechanisms
US20020022769A1 (en) * 1999-03-03 2002-02-21 Smith Vincent A. Portable video laryngoscope
US8096945B2 (en) * 2008-06-13 2012-01-17 Obp Corporation Disposable speculums having single-sided support and operating mechanism
US20160249797A1 (en) * 2005-04-01 2016-09-01 Welch Allyn, Inc. Vaginal speculum apparatus

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4900306A (en) * 1988-01-15 1990-02-13 Corpak, Inc. Device for intubation of percutaneous endoscopic ostomy
US4979498A (en) * 1989-10-30 1990-12-25 Machida Incorporated Video cervicoscope system
US6086603A (en) * 1998-12-14 2000-07-11 Syntheon, Llc Luminal port device having internal and external sealing mechanisms
US20020022769A1 (en) * 1999-03-03 2002-02-21 Smith Vincent A. Portable video laryngoscope
US20160249797A1 (en) * 2005-04-01 2016-09-01 Welch Allyn, Inc. Vaginal speculum apparatus
US8096945B2 (en) * 2008-06-13 2012-01-17 Obp Corporation Disposable speculums having single-sided support and operating mechanism

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112535501A (zh) * 2020-12-02 2021-03-23 朱英宏 一种妇产科用宫腔取样装置

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