Medical device and method of manufacturing the same
Inventors
Okamoto, Shingo • Nishida, Kosei • Ono, Kazuhide
Assignees
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Abstract
A medical device includes a case obtained by mating a liquid-phase-portion case and a gas-phase-portion case to each other, a membrane member as an elastic member with which a liquid-phase portion covered by the liquid-phase-portion case and a gas-phase portion covered by the gas-phase-portion case are separated from each other, fixing parts and at which the liquid-phase-portion case and the gas-phase-portion case that are mated to each other are fixed to each other, holding surfaces and between which a peripheral edge of the membrane member is held, and a sealing part that seals the entirety of the peripheral edge of the membrane member held between the holding surfaces and. The medical device has a releasing part that releases the pressure in an air gap produced between the sealing part and the fixing parts.
Core Innovation
A medical device includes a case obtained by mating a first case portion and a second case portion, where an elastic membrane is attached to the case to separate a first housing space covered by the first case portion from a second housing space covered by the second case portion. Fixing parts are provided at respective peripheries of the first case portion and the second case portion and fix the mated case portions by melting, while holding surfaces at the peripheries hold a peripheral edge of the elastic membrane.
A sealing part is provided at a periphery of the first case portion or the second case portion on an inner side with respect to the fixing parts, sealing an entirety of the peripheral edge of the elastic membrane held between the holding surfaces and extending around the peripheral edge. Between the case and the elastic membrane, an air gap is located and extends between the sealing part and the fixing parts, and a releasing part releases pressure in the air gap.
The releasing part serves as a cut part formed in a region of the fixing part, and the cut part releases pressure generated in the air gap when the case portions are fixed. The cut part is closed by melting of the fixing parts or regions around the fixing parts, the fixing parts are annularly formed, and the cut part extends in a radial direction in the fixing parts.
The device separates a first housing space and a second housing space so that liquid pressure is detected via pressure detection using the gas-phase pressure, and the releasing behavior during or after annealing/autoclave sterilization is used to improve reliability by preventing excessive pressure in the air gap that could displace the membrane and degrade sealing.
Claims Coverage
The document includes one independent claim directed to a medical device with a mated two-portion case, an elastic membrane, a sealing part, and a releasing part that manages pressure in an air gap. The dependent claims refine the pressure-releasing behavior, the pressure-detection arrangement using separated liquid-phase and gas-phase spaces, and the geometry of the cut part.
Mated two-portion case with elastic membrane separating housing spaces
A medical device comprising a case obtained by mating a first case portion and a second case portion, and an elastic membrane attached to the case to separate a first housing space covered by the first case portion and a second housing space covered by the second case portion.
Annular melting fixation with holding surfaces and peripheral-edge sealing
Fixing parts at the respective peripheries of the first case portion and the second case portion fix the mated case portions by melting, holding surfaces hold a peripheral edge of the elastic membrane, and a sealing part provided on an inner side with respect to the fixing parts seals an entirety of the peripheral edge of the elastic membrane.
Releasing cut part that releases air-gap pressure and is closed by melting
A releasing part serving as a cut part in a region of the fixing part releases pressure in an air gap located between the case and the elastic membrane and extending between the sealing part and the fixing parts, and the cut part is closed by melting of the fixing parts or regions around the fixing parts.
Radially extending cut part within annular fixing parts
The fixing parts are annularly formed, and the cut part extends in a radial direction in the fixing parts.
Pressure detection via separated liquid-phase and gas-phase portions
The medical device is connectable to a liquid flow route and includes separate liquid-phase and gas-phase housing spaces separated by the elastic membrane, with liquid pressure detected via pressure detection using the gas-phase pressure.
Air-gap pressure release during fixation
The releasing part releases pressure generated in the air gap when the first case portion and the second case portion are fixed to each other at the fixing parts.
Across the independent claim and its refinements, the inventive scope is a sealing structure around an elastic membrane edge combined with an air gap managed by a releasing cut part that releases pressure during fixation and is subsequently closed by melting, together with annular fixing parts and a radial cut extension. Dependent claim refinements further specify pressure detection using separated liquid-phase and gas-phase housing spaces.
Stated Advantages
Improves reliability during annealing/autoclave sterilization by preventing excessive pressure in the air gap that could displace the membrane and degrade sealing.
Documented Applications
Used in a dialysis apparatus and dialysis blood circuits, including a venous blood circuit, where liquid pressure is detected via pressure detection using the gas-phase pressure sensor readings.
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