WO2017004034A1 - Dispositif de sonde utérine et procédés d'utilisation associés - Google Patents

Dispositif de sonde utérine et procédés d'utilisation associés Download PDF

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Publication number
WO2017004034A1
WO2017004034A1 PCT/US2016/039807 US2016039807W WO2017004034A1 WO 2017004034 A1 WO2017004034 A1 WO 2017004034A1 US 2016039807 W US2016039807 W US 2016039807W WO 2017004034 A1 WO2017004034 A1 WO 2017004034A1
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WO
WIPO (PCT)
Prior art keywords
inner rod
outer tube
distal end
uterine sound
proximal end
Prior art date
Application number
PCT/US2016/039807
Other languages
English (en)
Inventor
Gabrielle Akwele NORTEY
Dominique JOHNSON
Elon Nadeen SMITH
Huan-Chi Lin
Original Assignee
Covidien Lp
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 Covidien Lp filed Critical Covidien Lp
Publication of WO2017004034A1 publication Critical patent/WO2017004034A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4318—Evaluation of the lower reproductive system
    • A61B5/4325—Evaluation of the lower reproductive system of the uterine cavities, e.g. uterus, fallopian tubes, ovaries

Definitions

  • a device termed as a "uterine sound” is used to measure distances and the position of the uterus. With such a device, it can be difficult for physicians to know the amount of force they are applying to the uterine tissue. Unfortunately, this difficulty can lead to an unknown perforation or a tear in the uterine wall, which occurs 1 in every 100 procedures. Any technology that reduces the risk of perforation while maintaining the functionalities of a traditional uterine sound would provide a competitive advantage in the marketplace.
  • FIGS. 1A and 1 B show views of a measurement system according to certain embodiments of the present disclosure.
  • FIGS. 2A - 2C show a first side view (2A), a second side view (2B), and a perspective view (2C) of an inner rod according to certain embodiments of the present disclosure.
  • FIGS. 3A and 3B show a side view (3A) and a perspective view (3B) of the outer tube according to certain embodiments of the present disclosure.
  • FIGS. 4A and 4B show a side view (4A) and a partial perspective view (4B) of a uterine sound according to certain embodiments of the present disclosure.
  • FIG. 5 is a flow chart of a method of measurement using a uterine sound according to certain embodiments of the present disclosure.
  • “Tapered” and a term indicative of direction shall mean that a component has a diameter that decreases towards the stated direction.
  • "Removably coupled” shall mean a first component coupled to a second component such that first component can be decoupled from the second component without destroying or rendering the first or second components non-functional.
  • a uterine sound is used as a precursor to gynecological procedures that use calibration of specific tool lengths before inserting the tools into the uterine cavity.
  • a majority of these procedures are considered to be minimally invasive and may comprise intrauterine device insertion, hysterectomy, hysteroscopy, dilation and curettage, artificial insemination, and endometrial ablation.
  • a bimanual examination e.g., using two hands
  • the uterine sound is manually bent to mimic the observed uterine curvature.
  • the uterine sound measurement process can be difficult even for some of the most seasoned practitioners. Variables such as physician experience, varying uterine tissue properties, patient health and history, and uterine inversion can heavily influence the risk of perforation of the uterine wall.
  • the uterine sound discussed herein provides a safe and effective solution at least by reducing the risk of perforation. Consequently, it is likely that users of the device will feel more confident in their own abilities throughout the duration of the measurement process and that patients will gradually begin to experience an increase in physician trust based upon the improved device and associated method of use.
  • a primary challenge to effectively using a uterine sound is understanding the proper amount of force to apply to the tool as it is guided toward the uterine wall (fundus).
  • the prior devices were inserted by the physician with a pivot point of an elbow, a shoulder, or their feet, that is, the range of motion possible in the use of the prior devices contributes to the difficulty of use.
  • the physician since the position or inversion of a woman's uterus can vary, the physician may find it challenging to bend or turn the uterine sound to the perfect angle for insertion. This anatomical challenge can cause physicians to make potentially dangerous decisions regarding the amount of force they apply to the uterine sound when resistance is felt.
  • Another major challenge that is posed by prior uterine sound devices is an inability to inform the user regarding device position within the patient or proximity to the uterine wall(s). Although the bimanual exam can inform the physician regarding the general orientation of the uterus, it is still possible for misinterpretation to occur. The case of misinterpretation could be exceptionally dangerous if a uterine anomaly (irregularly shaped uterus) is present. With prior uterine sound devices, the physician "blindly" guides the instrument. If a morphological irregularity is present, the physician may be at a higher risk of perforating any portion of the uterus due to assuming healthy morphology.
  • a uterine sound designed, fabricated, and used to reduce the amount of applicable force on the uterine tissue in comparison to the prior art sound devices by employing a new single-handed method of advancement that allows for additional control and a smaller range of motion using the ring-and-winged handle mechanism discussed below.
  • the new sound provides a more precise and accurate method of measuring uterine length while reducing abrasive contact with the tissue.
  • the uterine sound discussed herein comprises an outer component referred to as an outer tube and an inner component that may be referred to as an inner rod, though it may be hollow or solid.
  • the outer tube comprises a measurement window that reports a specific measurement to the user in centimeters, millimeters, inches, or another measurement. The measurement is taken using the window and a plurality of markings on the inner rod, and correlates to the extension of the inner rod into the patient.
  • the outer tube further comprises a winged handle under which the user can place an index finger and middle finger. During use, the outer tube serves to stabilize the uterine sound against the opening of the cervix and to guide the inner rod into the cervix.
  • the inner rod of the device is a rod with a largest diameter smaller than the inside diameter of the outer tube, and the inner rod's diameter may be tapered towards the distal end.
  • a ring At the proximal end of the inner rod is a ring in which the user will place their thumb during use to operate the device.
  • the distal end of the inner rod is advanced into the cervix to dilate the cervix as the device is being inserted to reduce patient discomfort.
  • the rubberized tip serves to reduce abrasive contact with the uterine tissue and reduce risk of perforation.
  • the user may advance the uterine sound by placing their thumb in the ring and their index and middle finger under the wings and advance or pull back the device by pressing in or pulling back with their thumb.
  • a resistance mechanism may be associated with the inner rod within the device, and the resistance mechanism helps regulate the advancement of the inner rod, giving the user more control of the uterine sound during insertion.
  • FIGS. 1A and 1 B show a uterine sound system used to take a measurement of a uterus in accordance with example embodiments.
  • a uterine sound 100A comprises an outer tube and an inner rod (not shown separately in FIGS. 1A and 1 B but discussed below) telescoped through the proximal end of the outer tube along a central axis 116.
  • the uterine sound 100A shows the handle in a retracted state, the handle is shown at the proximal side 102 and comprises a ring 108 on the proximal end of the inner rod and a handle component 212 on a proximal end of the outer tube.
  • the ring 108 comprise a thickness from 0.15" to about 0.40,” and may be a circle with a diameter from about 1.0" to about 2.0. "or an ellipse with a first diameter along the central axis 1 16 from about 1.0" to about 2.0,” and a second diameter with a second, smaller diameter from about 1.0" to about 2.0,” as measured perpendicular to the central axis 1 16.
  • the handle component 212 comprises at least two wings 212A extending outward from an outer surface of the outer tube, each wing 212A comprises a base coupled to the outer tube 106, a tip at a distal end of the wing, and a curved medial surface that opens toward the distal end 104 of the outer tube.
  • the distance from the tip of the distal end of the wing to a middle point of the curved medial surface is from about 0.5" to about 1.0," and a thickness of each wing measured parallel to the central axis may be from about 0.15" to about 0.40.”
  • a measurement window 110 is shown along an elongate shaft 106 of the outer tube of the uterine sound 100A.
  • the measurement window 1 10 may comprise a diameter from about 0.2" to about
  • a pliable tip 112 is disposed at the distal end 104 and may be coated with a lubricant such as silicone.
  • the pliable tip 1 12 and may comprise various configurations of lengths, materials, and cross- sectional geometries, and may taper towards the distal end 104. In the example in FIG.
  • the pliable tip 1 12 is disposed at the entrance of an aperture 114 such as a uterus, and is extended through the aperture 114 as shown in 100B using the handle, in particular the ring 108 and the handle component 212, to abut a wall of a cavity accessed by the aperture 114.
  • the pliable tip 112 is extended through the aperture 114 by way of the handle.
  • the aperture 114 may be a cervix, and the pliable tip 112 may be advanced via the ring 108 and using the handle component 212 as leverage to move the ring 108.
  • the pliable tip 1 2 and the ring 108 are a part of the uterine sound, and are either formed as an integral part of or coupled to an inner rod (not shown) which is telescoped through an outer tube.
  • the advancement of the inner rod via the ring 108 and handle component 212 may be performed using one hand, in contrast to currently employed methods.
  • FIGS. 2A and 2B show a first side view (2A) and a second side view (2B) of an inner rod 202.
  • the inner rod 202 comprises a pliable tip 1 12 at the distal end 04, the ring 108 at the proximal end 102, and a pliable component 208, that may also be referred to as a resistance mechanism, is disposed on an elongate shaft 206 of the inner rod 202.
  • the inner rod 202 may be from about 10.0" to about 15.0" in length, comprise a diameter suitable for telescoping through the outer tube, and may comprise a consistent outer diameter along a first portion of the elongate shaft 106 and a diameter tapered towards the distal end 104 of the inner rod 202 along a second portion of the elongate shaft 106.
  • This second portion may comprise the pliable tip 112 and, in some embodiments, a portion of the inner rod 202 adjacent to the pliable tip 112.
  • the second (tapered) portion comprises 20%- 40% of the elongate shaft's 106 overall length.
  • the pliable component 208 may comprise a ring shape or another shape, and may be composed of any pliable material that, alone or with a lubricant coating, can create resistance between the inner rod 202 and an outer tube (not shown).
  • the pliable component 208 may be removably coupled to the elongate shaft 206, or may be formed integrally of the same or a similar material as the inner rod 202.
  • the elongate shaft 206 comprises a mechanism to retain the pliable component 208, and the inner rod 202 is telescoped through the pliable component 208 so that the retention mechanism permanently or removably couples the pliable component 208 to the inner rod 202.
  • the resistance mechanism may be an annular groove or a raised feature formed on the inner rod such that it retains the pliable component 208 during the sliding engagement of the inner rod 202 with the outer tube.
  • the pliable component 208 may be disposed at various points along the elongate shaft 206. In some embodiments, more than one pliable component 202 may be employed along the elongate shaft. In one example, at least two pliable components may be coupled to or formed as a part of the inner rod 202, and may be spaced to abut each other, or may be spaced at predetermined uniform or non-uniform intervals along the inner rod 202.
  • FIG. 2B additionally shows a magnified view of a portion of a plurality of markings 204 disposed along a portion of the elongate shaft.
  • the plurality of markings 204 may be formed integrally with the inner rod 202, and in alternate embodiments, the plurality of markings 204 may be printed by inkjet or other means, or may be stamped during or after the fabrication of the inner rod 202.
  • the plurality of markings 204 comprise measurement markings and may be configured as to be molded into the inner rod 202, e.g., to be flush with the surface of the inner rod 202.
  • the inner rod 202 may be formed from transparent or semi-transparent material, or other materials that enable markings to be indicated on or within the inner rod 202.
  • the inner rod 202 may be hollow in whole or in part and the markings may be molded or otherwise formed on the inside of the inner rod 202, so that the markings do not cause patient discomfort, but are still visible through a measurement window.
  • FIG. 2C shows a perspective view of an inner rod 202, as well as a magnified view of the elongate shaft 206 where the pliable component 208 is disposed, as well as an indication of where some of the plurality of markings 204 may be located with respect to the pliable component 208.
  • the pliable component 208 may be telescoped over the inner rod 202 and may be permanently or removably coupled to the shaft 206. In an alternate embodiment, the pliable component 208 is formed integrally with the inner rod 202. While the pliable component 208 is shown in FIG.
  • the plurality of markings 204 may extend along more or less of the elongate shaft 206 than is illustrated in FIG. 2C, and may comprise various units of measurement.
  • FIG. 3A shows a side view of an outer tube 302 of a uterine sound.
  • the outer tube comprises a window 110 which may be formed, as viewed in the side view in FIG.3A, as a circle. In alternate embodiments, the window 110 may be formed as a square, triangle, or other polygon or combinations of shapes.
  • the handle component 212 is disposed at the proximal side 306 and the elongate shaft 106 is open on the distal end 308.
  • FIG. 3B is a perspective view of the outer tube 302, including the through hole 304 that extends from the distal end 308 to the proximal 306 end of the outer tube 302.
  • an overall length of the outer tube may be from about 8.0" to about 12.0.”
  • a diameter of the through hole 304 may be from about 0.15" to about 0.33,” and an outer diameter of the outer tube 302 may be from about 0.20" to about 0.45.”
  • FIGS. 4A and 4B illustrate a uterine sound 100B comprised of an inner rod 202 telescoped through and slidingly engaged with an outer tube 302.
  • FIG. 4A is a side view of the uterine sound 100B, at least some of the plurality of markings discussed above may be viewed through the window 1 10.
  • FIG. 4A illustrates the inner rod 202 telescoped through the proximal end 306 of the outer tube 302.
  • the outside diameter of the inner rod 202 is configured such that the inner rod 202 can be telescoped through an outer tube when the pliable component 208 is coupled to the inner rod wherein resistance is created between the inside surface of the outer tube 302 and the pliable component 208.
  • FIG. 4B is a partial cutaway view of the uterine sound 100B taken substantively along line 4B-4B in FIG. 1 B.
  • FIG. 4B illustrates the elongate shaft 106 of the outer tube, and the pliable component 208 in contact with an inner surface of the elongate shaft 106 of the outer tube 302 as indicated by boundary line 404.
  • the outer tube 106 comprises a thickness 406, and well as an outside surface 408 and an inner surface (not shown other than by boundary line 404).
  • the pliable component 208 may be formed integrally with the inner rod 202.
  • the inner rod 202 may be telescoped through the pliable component 208 such that the pliable component 208 is retained by a retention mechanism (not shown).
  • the retention mechanism may be formed on the distal side and/or on the distal and proximal sides of a location along the inner rod 202 where the pliable component 208 is to be retained when the inner rod is slidingly engaged with the outer tube 302. This coupling example is indicated by the boundary line 410 in FIG. 4B.
  • FIG. 5 is a flow chart of a method 500 of measurement using a uterine sound.
  • a resistance mechanism is telescoped over an inner rod comprising a plurality of markings along an elongate shaft, a ring at the proximal end and a pliable tip at the distal end.
  • the inner rod is telescoped through an outer rube at block 504 to form the uterine sound.
  • the method 500 may begin at block 506, where the uterine sound is positioned at an aperture. The method 500 may begin at block 506, for example, if the uterine sound is provided to a healthcare provider already assembled, including the resistance mechanism.
  • the inner rod including the pliable tip is advanced through the aperture by advancing the inner rod relative to the outer tube, the resistance mechanism provides a predetermined resistance via contact between the resistance mechanism and an inner surface of the outer tube to movement during translation of the inner rod relative to the outer tube.
  • a measurement associated with an amount of advancement of the inner rod is determined based upon at least some of the plurality of markings on the inner rod that are viewed through a window though the outer tube.
  • the inner rod and/or entire uterine sound device is retracted from the aperture.
  • the advancing of the inner rod at block 508 further comprises advance the inner rod by way of a ring coupled to a proximal end of the inner rod and a winged handle coupled to the same side of the outer tube.
  • the advancement at block 508 and retraction at block 512 may be accomplished by a single actor using a single hand via the handle comprised of the ring and winged component discussed herein.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Dentistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

L'invention concerne une sonde utérine et un procédé d'utilisation de la sonde utérine, qui comprend une tige intérieure montée de manière télescopique à travers un tube extérieur. Le tube extérieur comprend une extrémité proximale, une extrémité distale et une fenêtre, l'extrémité proximale comprenant une poignée, et la tige intérieure comprenant une tige rigide allongée, une extrémité proximale et une extrémité distale; l'extrémité proximale comprend un anneau, l'extrémité distale comprend un bout souple, et l'extrémité distale de la tige intérieure est montée de manière télescopique à travers le tube extérieur, le long d'un axe central. Un mécanisme de résistance, placé entre le tube extérieur et la tige intérieure, est conçu pour fournir une résistance au mouvement relatif produit entre le tube extérieur et la tige intérieure à mesure que la tige intérieure est avancée.
PCT/US2016/039807 2015-06-29 2016-06-28 Dispositif de sonde utérine et procédés d'utilisation associés WO2017004034A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562185780P 2015-06-29 2015-06-29
US62/185,780 2015-06-29

Publications (1)

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WO2017004034A1 true WO2017004034A1 (fr) 2017-01-05

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2035097A (en) * 1978-11-30 1980-06-18 Hasson H Gynecological instrument
US20060135887A1 (en) * 2004-12-20 2006-06-22 Sampson Russel M Uterine sound
US20090137970A1 (en) * 2006-04-21 2009-05-28 Samuel George Uterine manipulators
US20110028864A1 (en) * 2009-07-31 2011-02-03 Margaret Doubrava Uterine sound device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2035097A (en) * 1978-11-30 1980-06-18 Hasson H Gynecological instrument
US20060135887A1 (en) * 2004-12-20 2006-06-22 Sampson Russel M Uterine sound
US20090137970A1 (en) * 2006-04-21 2009-05-28 Samuel George Uterine manipulators
US20110028864A1 (en) * 2009-07-31 2011-02-03 Margaret Doubrava Uterine sound device

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