Anorectal Manometer Probe with Disposable Sheath and Inflatable Balloon
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Solution Overview
Problem
Current anorectal manometers are large, expensive, and require time-consuming calibration, limiting their portability and widespread clinical adoption.
Innovation Solution
A compact, hand-held anorectal manometer with a probe equipped with multiple pressure sensors and a flexible, impermeable sheath that provides a continuous covering and includes an inflatable balloon for pressure measurement, while preventing contamination and infection transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If water-perfused manometer systems are used, then pressure measurement capability is achieved, but device size becomes large and portability is reduced
Solution Approach 1:
The patent extracts the water perfusion system from the probe and places it in a separate reservoir. The probe itself becomes much smaller and lighter, containing only the essential sensing elements, while the bulky fluid reservoir is positioned externally. This separation resolves the contradiction by maintaining pressure measurement capability through fluid connection while dramatically reducing the probe's volume for improved portability.
Solution Approach 2:
The patent nests the pressure sensing elements within the probe structure, with the probe inserted into the patient's rectum. The external reservoir contains the perfusion fluid and connects to the probe through flexible tubing. This nested arrangement allows the measurement system to function while keeping the insertable portion compact and portable.
2Measurement precision
If traditional anorectal manometer systems are used, then diagnostic measurement capability is provided, but purchase cost and per-procedure cost become high
Solution Approach 1:
The patent segments the manometer system into separate functional components: a disposable probe for insertion, a reusable reservoir for the expensive perfusion fluid, and external connection tubing. This segmentation allows the costly fluid reservoir to be reused across multiple procedures while only the inexpensive probe is discarded, significantly reducing per-procedure costs while maintaining full diagnostic measurement capability.
Solution Approach 2:
The patent employs a disposable probe design that is inexpensive to manufacture and discard. The probe contains the essential sensing elements but not the expensive perfusion fluid reservoir. By making the probe disposable and cheap, the system can be used in more settings without high per-procedure costs, while the reusable reservoir maintains measurement precision across multiple uses.
3Measurement precision
If calibration process is implemented, then measurement accuracy is ensured, but procedure time becomes time-consuming
Solution Approach 1:
The patent performs calibration actions in advance by designing the probe with pre-set flow resistance characteristics and perfusion rates. The system is calibrated during manufacturing rather than at the point of use, eliminating time-consuming calibration steps during patient procedures. This preliminary calibration maintains measurement accuracy while saving valuable procedure time.
4Object-affected harmful factors
If probe is made disposable for infection prevention, then infection control is improved, but per-procedure expense increases
Solution Approach 1:
The patent segments the system into a disposable probe and a reusable reservoir. Only the probe, which contacts the patient, is discarded after single use to prevent infection. The expensive reservoir containing the perfusion fluid is reused across multiple procedures. This segmentation achieves infection control goals while minimizing per-procedure expenses by preserving the valuable reusable components.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The manometer is capable of measuring pressures at multiple locations, is economical in manufacture and use, and is designed to be more widely adopted in clinical practice, enhancing diagnostic capabilities and infection control.
Implementation Method 1
the sheath comprises flexible membranous material so that pressure applied to the stem portion of the sheath is transmitted through the sheath to the proximal portion of the probe, to be sensed by the pressure sensors
Implementation Method 2
the probe being provided with a plurality of proximal pressure sensors responsive to pressures applied to the proximal portion of the probe
Data Source
AI summary
The invention provides an assembly for anorectal manometry, comprising a manometer (10, 210, 410) and a sheath (14) which provides a barrier against contamination of the manometer with foreign matter, and hence a precaution against transmission of infection. The manometer comprises a probe (12, 212, 212) comprising a proximal portion (264b) and a distal tip portion (264a), the probe being insertable through an anus so that the distal tip portion extends into the rectum, and the probe being provided with a plurality of proximal pressure sensors (40, 164, 240) responsive to pressures applied to the proximal portion of the probe. The sheath is formed to receive the probe and to provide a continuous covering over at least the proximal portion and the distal tip portion of the probe. It comprises a proximal stem portion (52) for receiving at least the proximal portion of the probe, and a distal balloon portion (50) whose interior communicates with an inflation conduit (54), enabling inflation of the balloon portion with a pressure medium introduced through the inflation conduit whilst the balloon portion is disposed in the rectum. The sheath comprises flexible membranous material so that pressure applied to the stem portion of the sheath is transmitted through the sheath to the proximal portion of the probe, to be sensed by the pressure sensors. A seal is provided against flow of the pressure medium from the balloon portion into the stem portion of the sheath.