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WO2001076468A1 - Dispositif de dimensionnement pour l'uretre - Google Patents

Dispositif de dimensionnement pour l'uretre Download PDF

Info

Publication number
WO2001076468A1
WO2001076468A1 PCT/US2001/010654 US0110654W WO0176468A1 WO 2001076468 A1 WO2001076468 A1 WO 2001076468A1 US 0110654 W US0110654 W US 0110654W WO 0176468 A1 WO0176468 A1 WO 0176468A1
Authority
WO
WIPO (PCT)
Prior art keywords
urethra
shaft
retention structure
stylet
sizing
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.)
Ceased
Application number
PCT/US2001/010654
Other languages
English (en)
Inventor
Claude Tihon
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.)
Conticare Medical Inc
Original Assignee
Conticare Medical Inc
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 Conticare Medical Inc filed Critical Conticare Medical Inc
Publication of WO2001076468A1 publication Critical patent/WO2001076468A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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—Measuring 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

Definitions

  • the present invention relates generally to a device and method for measurement of a urethra, and more particularly to a device and method for measuring the length of a female human's urethra.
  • the length from the meatus to the sphincter is then read from the inner member's markings relative to the outer sleeve's distal end.
  • Other devices for measuring from the meatus to the sphincter sense the pressure exerted on a probe that is inserted into the urethra. As the probe is advanced, an increased pressure is exerted until the probe extends past the sphincter. At this point, the user notes the distance the probe has been inserted and correlates this distance to urethral length.
  • the devices measure the distance between the meatus and the sphincter but this distance is not always an accurate representation of the urethra's length because the sphincter muscle's location varies and does not typically extend the proximal most end of the urethra.
  • the devices can be cumbersome. Some requiring manipulation of the inner member until the sphincter is located. Once located with these devices, the inner member can slip. Further, the device can require urine in the bladder for measurement. Urine can be unsanitary and will typically require the use of a collection bag or other receptacle.
  • the manufacturing costs of the above-described measuring devices and other available measuring devices are relatively high. As with most medical devices reduction of manufacturing costs is important. Therefore, a need exists for a measuring device that is not only simple to use but is also simple to manufacture. Simplicity typically reduces manufacturing costs and thereby decreases the costs of treating patients.
  • the present invention provides a urethra sizing device that is simple to construct and easy to use, and that is capable of providing accurate measurements irrespective of the volume of urine in the patient's bladder.
  • the urethra sizing device of the present invention accounts for the bladder's asymmetry.
  • the measuring device is simple to use and atraumatic.
  • the measuring device is also simple in design and therefore, typically requires a relatively simple manufacture.
  • the urethra sizing device includes a shaft and a retention structure.
  • the device can have a lumen coextensive with the shaft and extending at least partially into the retention structure configured to receive a stylet.
  • the device can also include a hydrogel coating covering some or all of the device's surface.
  • the shaft includes a plurality of graduated markings for determining the length of the urethra and can be configured to determine the functional diameter of the urethra.
  • the shaft can also include at least one orientation marking.
  • the orientation marking comprises a longitudinal line on the shaft.
  • the retention structure is configured asymmetrically about the shaft's longitudinal axis.
  • the urethra is sized by first rendering the retention structure substantially rectilinear.
  • the retention structure may be rendered substantially rectilinear by inserting a stylet into the lumen.
  • the substantially rectilinear sizing device is inserted into the urethra and the retention structure is positioned within the bladder. Once in the bladder, the retention structure is allowed to reform into its original shape.
  • the retention structure is then positioned adjacent the neck of the bladder in a predetermined orientation.
  • the length of the urethra is then read from the graduated markings adjacent the external urethral orifice.
  • the urethra's functional diameter can be determined by extrapolation of the amount of urine passing through the urethra or alternatively, the urethra's diameter can be more precisely determined by inserting a plurality of urethra measuring devices having shafts with various diameters.
  • Fig. 1 illustrates a side view of an embodiment for a urethra measuring device in accordance with the present invention
  • Fig. 2A illustrates a side view of an embodiment of a urethral measuring device having a removable oversleeve.
  • Fig. 2B illustrates a left end view of the urethra measuring deice of Fig. 2A.
  • Fig. 3 A illustrates a right end view of the urethra measuring device of Fig. 1 showing a first embodiment of the retention structure
  • Fig. 3B illustrates a right end view of the urethra measuring device of Fig. 1 showing a second embodiment of the retention structure
  • Fig. 4A illustrates a side view urethra measuring device of Fig. 1 with a stylet partially inserted into the urethra measuring device
  • Fig. 4B illustrates a side view urethra measuring device of Fig. 1 with a stylet fully inserted into the urethra measuring device.
  • the present invention is applicable to a variety of urethral measurement devices.
  • the invention is described in the context of a urethral measurement device for measurement of a woman's urethra to determine proper length dimension for a urethral device.
  • the urethral devices can include plugs, catheters, urethral occlusion devices or other devices for insertion in the urethra.
  • the appended claims are not intended to be limited to any specific example or embodiment described in this specification. It will be understood by those skilled in the art that the present invention may be used for measurement of other urethras and lumens. Further, in the drawings described below, the reference numerals are generally repeated where identical elements appear in more than one figure.
  • Fig. 1 illustrates an embodiment of a urethra measurement device 10 in accordance with the present invention.
  • Measurement device ,10 includes a shaft 14 at a proximal end and a retention structure 16 at the distal end.
  • Measurement device 10 is typically composed of a biocompatible flexible, elastomeric material, including, but not limited to silicone, PTFE, ETFE, polyurethane, polyethylene or other materials known to those skilled.
  • a hydrogel or other lubricious coating may be provided on the device to better facilitate insertion into a patient's urethra.
  • measurement device 10 includes a lumen extending from its proximal end 17 to its distal end 18. The distal end of the lumen at distal end 18 of measurement device 10 is sealed or closed off to allow cooperation with a stylet 30, shown in Fig. 3, for insertion of the measurement device into the urethra through its meatus, as described below.
  • the shaft is configured for both functional diametric and anatomical longitudinal sizing of a patient's urethra.
  • measuring devices having a variety of shaft diameters are provided and inserted individually into the patient's urethra.
  • a single measuring device 10 having one or more removable oversleeves 34 could be provided, wherein oversleeves 34 extend along at least a portion of shaft 14.
  • Oversleeves 34 being individually removable to incrementally reduce the size of shaft 14.
  • Oversleeves 34 are typically made from a biocompatible polymer and are removably attached to shaft 14 to prevent the leaking of urine during measurement.
  • the actual diametric measurement may vary depending on the function of the urethral device to be used.
  • the functional diameter is device dependent. That is, the functional diameter is the diameter of a particular device required for the device to function properly within a particular urethra.
  • the functional diameter may, for example in the case of a urethral occlusion device, be the functional urethra closure diameter. That is, the diameter required for the sphincter to contract against a urethral occlusion device in order to prevent the leaking of urine.
  • shaft 14 is provided with a plurality of graduated markings 20.
  • Graduated markings 20 are placed along shaft 14 at measured distances from retention structure 16 that correspond to typical anatomical lengths of human urethras. For example, the distances can include 3.5 centimeters, 4.0 centimeters and 4.5 centimeters for use with women. These exemplary distances represent common urethral lengths in women.
  • Graduated markings 20 are typically in the form of lines running around the circumference of shaft 14.
  • an orientation marking 22 may be provided to allow the user to determine that the retention structure 16 is properly oriented in the bladder to provide an accurate measurement.
  • Orientation marking 22 is typically in the form of a line extending parallel to the shaft's longitudinal axis. Other configurations for the markings will be evident to those skilled in the art.
  • Figs. 3A and 3B illustrate two embodiments of the retention structures in accordance with the present invention.
  • Figs. 3 A and 3B are shown as closed and open loops, respectively, for illustrative purposes only.
  • the retention structures are typically shaped to correspond to the distal end of the catheter for which the patient is being measured.
  • the retention structures are asymmetrical about shaft 18, shown in Figs. 3 A and 3B along its longitudinal axis.
  • Fig. 3 A shows an embodiment of retention structure 16 wherein distal end 18 is connected to shaft 14.
  • Fig. 3B shows an embodiment of the retention structure 16 wherein distal end 18 is not attached to shaft 14.
  • Those skilled in the art will recognize the variety of configurations for retention structure 16. Regardless of configuration, retention structure 16 is asymmetrically disposed about shaft 14 so as to accurately determine the length of the urethral device to be used.
  • stylet 30 is typically provided to facilitate insertion of measuring device 10 into the urethra.
  • Stylet 30 may be provided with a stylet handle 32 to better facilitate the manipulation of the measuring device during insertion.
  • Stylet 30 is inserted into shaft 14 through a lumen that is open at the shaft's proximal end, as shown in Fig. 4A.
  • Measuring device 10 is typically lubricated. Hydrogel coated measuring devices, for example, are lubricated by simply moistening the device. Alternatively, a water- soluble lubricant, like K-Y Jelly, or other suitable lubricant could be used.
  • Stylet 30 is advanced into the shaft to orient the retention structure in a position allowing insertion through the urethra, as shown in Fig. 4B.
  • the stylet is typically advanced until the retention structure collapses in on itself due to its receipt of stylet 30.
  • distal end 18 is not attached to shaft 14, the distal end of stylet 30 may be inserted until the stylet's distal tip proximates end 18 within the lumen.
  • insertion of the stylet renders urethra measuring device 10 substantially rectilinear so as to allow the device to be inserted into a urethra.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Dentistry (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

Dispositif de dimensionnement pour l'urètre (10) servant à dimensionner un dispositif servant à la prévention de l'incontinence. Le dispositif de dimensionnement pour l'urètre (10) comprend une tige (14) et un élément de rétention (16). La tige (14) possède plusieurs marques graduées (20) éloignées à une certaine distance de la structure de rétention (16) et destinées à déterminer la longueur anatomique de l'urètre.
PCT/US2001/010654 2000-04-07 2001-04-02 Dispositif de dimensionnement pour l'uretre Ceased WO2001076468A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US54531500A 2000-04-07 2000-04-07
US09/545,315 2000-04-07

Publications (1)

Publication Number Publication Date
WO2001076468A1 true WO2001076468A1 (fr) 2001-10-18

Family

ID=24175735

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/010654 Ceased WO2001076468A1 (fr) 2000-04-07 2001-04-02 Dispositif de dimensionnement pour l'uretre

Country Status (1)

Country Link
WO (1) WO2001076468A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150099999A1 (en) * 2013-10-03 2015-04-09 Personal Medical Corp. System and method for measuring female urethral length
CN111419428A (zh) * 2020-04-08 2020-07-17 郑州大学第一附属医院 尿道下裂手术用标记装置
CN112806971A (zh) * 2021-03-16 2021-05-18 上海市同济医院 一种泌尿系统内镜下使用的测量装置

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5171248A (en) * 1991-02-27 1992-12-15 Intermedics Orthopedics, Inc. Medullary caliper
US5864961A (en) * 1996-09-04 1999-02-02 Vaughan; Ward P. Urethral probe for diagnosing stress incontinence
US5885228A (en) * 1996-05-08 1999-03-23 Heartport, Inc. Valve sizer and method of use

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5171248A (en) * 1991-02-27 1992-12-15 Intermedics Orthopedics, Inc. Medullary caliper
US5885228A (en) * 1996-05-08 1999-03-23 Heartport, Inc. Valve sizer and method of use
US5864961A (en) * 1996-09-04 1999-02-02 Vaughan; Ward P. Urethral probe for diagnosing stress incontinence

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150099999A1 (en) * 2013-10-03 2015-04-09 Personal Medical Corp. System and method for measuring female urethral length
US9931060B2 (en) * 2013-10-03 2018-04-03 Personal Medical Corp. System and method for measuring female urethral length
CN111419428A (zh) * 2020-04-08 2020-07-17 郑州大学第一附属医院 尿道下裂手术用标记装置
CN112806971A (zh) * 2021-03-16 2021-05-18 上海市同济医院 一种泌尿系统内镜下使用的测量装置

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