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Vaginal measurements using vaginal ring

A vaginal ring and vaginal mucosa technology, applied in the direction of testing muscle strength, diagnostic recording/measurement, application, etc., can solve problems such as suboptimal compliance and pain

Pending Publication Date: 2020-11-24
里加利私人有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Frequent stabbing can cause pain, and compliance may not be optimal

Method used

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  • Vaginal measurements using vaginal ring
  • Vaginal measurements using vaginal ring
  • Vaginal measurements using vaginal ring

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Determination of glucose in vaginal transudates from healthy volunteers

[0035] introduce

[0036] This pilot study was conducted to investigate whether the glucose sensor could measure changes in glucose concentration when flushed with a bolus solution near the intravaginal sensor. In addition, it is important to see if glucose in the vagina can be measured when the device is placed in contact with the vaginal wall.

[0037] The glucose sensor ring device thus obtained was placed in the vagina of a 43-year-old healthy female volunteer in contact with the vaginal wall for a duration of approximately 1 hour and 20 minutes (71 minutes). Capillary blood glucose levels were obtained from a finger stick glucose test with a commercially available Bayer glucose meter. In this pilot study, blood sugar was tested three times. Glucose bolus solutions (5 mM, 10 mM and 20 mM) were flushed vaginally through the cannula (2 mL per bolus).

[0038] Materials and methods

[0039]T...

Embodiment 2

[0056] Determination of glucose in vaginal exudates of diabetic patients

[0057] introduce

[0058] The purpose of this example was to investigate the ability and effectiveness of the intravaginal device to measure glucose in transudate near the vaginal wall. In addition, the study aimed to investigate whether glucose sampled from vaginal wall exudates reflected glucose levels in capillary blood and interstitial fluid.

[0059] The intravaginal device used was a combination of the intravaginal ring (LiGalli) disclosed in WO2017 / 06029 and the glucose sensor technology described in EP2699690 (NovioSense). The ring and measurement sensor are placed directly against the vaginal wall in a flexible manner and do not penetrate the tissue itself, so the device is formally non-invasive in its classification.

[0060] The diagnostic catheter was retrofitted and coated with NovioSense coating before mounting it on the LiGalli ring device ( figure 1 ). The ring device thus obtained ...

Embodiment 3

[0081] Determination of Estradiol and LH in Vaginal Exudate

[0082] Use a small swab to scrape along the vaginal mucosa. The swab was then centrifuged, and 1 μl of sample fluid was retrieved. To measure the concentration of estradiol from this small volume, PBS solution was added and the presence of estradiol was tested. The sample was found to contain 0.082 nmol / L. Samples were diluted 75-50x. Due to the extremely small sample size and the high dilution factor, the values ​​obtained may not be very accurate, but in any case, this shows that estradiol can be detected in vaginal wall exudates.

[0083] In a similar manner, LH (luteinizing hormone) was also determined. For this, 1 μl of the sample was added to 199 μl of PBS. The concentration of LH is 200x 0.234=484U / L. In the same sample, the concentration of estradiol (E2) was 200 x 0.103 = 206 nmol / L. Likewise, the measurement accuracy is subject to the same limitations in the sampling method used.

[0084] This sugg...

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PUM

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Abstract

Method for measuring the presence of a compound or a physiological parameter in the human or animal body, comprising positioning an intravaginal ring that comprises a sensor for the compound or parameter to be measured in contact with the vaginal mucosa and recording a signal produced by the sensor. It is further disclosed a method for the combined administration and measurement of compounds in the human or animal body, comprising the administration of one or more biologically active compounds and the simultaneous and / or subsequent measurement of the presence and / or concentration of the same and / or another compound and / or physiological parameter that is the result of the administration of the one or more biologically active compounds, wherein the measurement is performed with a sensor thatis in contact with the vaginal mucosa.

Description

technical field [0001] The present invention relates to a method for measuring the presence of a compound or a physiological parameter in a human or animal body. Background technique [0002] For diagnostic and therapeutic purposes, it is relevant to be able to determine the presence of specific compounds in a human or animal body, eg in samples of blood, plasma, urine, faeces, semen, in the respiratory tract or on the skin, etc. For all these samples different techniques were used. Some of these techniques are invasive, such as drawing blood. [0003] For example, diabetics do use lancets or automated finger prick devices that pierce the skin so that a drop of blood can be drawn for testing. While this self-monitoring of blood sugar at home is a vast improvement over having to go to the hospital for blood draws, it can still be seen as a burden by patients. Frequent stabbing can cause pain, and compliance may not be optimal. [0004] One method of real-time measurement ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61B5/145A61B5/00A61K9/00A61B5/22
CPCA61B5/14532A61B5/14539A61B5/14546A61B5/227A61B5/4337A61B5/4839A61K9/0036A61B5/1107A61B5/14503A61B5/1451A61B5/4294A61B5/6847A61B2503/40
Inventor 威廉默斯·尼古拉斯·赫拉尔杜斯·玛丽亚·德·拉特
Owner 里加利私人有限公司
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