Probe cover and ultrasound diagnostic device with cover

Abstract

To provide a probe cover body for an ultrasound diagnostic apparatus which has high adhesion to a probe or a flat body surface and is capable of improving measurement accuracy, and an ultrasound diagnostic apparatus with a cover.SOLUTION: A probe cover body 22 covering a probe 12 in an ultrasound diagnostic apparatus 2 provided with a casing 11 and the probe 12 includes: a bracket 23 which is installed to the casing 11 and has an opening 31a facing the probe 12 in the state that the same is installed to the casing 11; and a flexible cover film 24 supported by the bracket 23 and covering an opening 31a. In the cover film 24, 50% modulus value in a longitudinal direction in a test piece whose thickness is between 60 μm and 10 μm, whose width is 15 mm and whose length is 40 mm is 10 MPa or less.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a probe cover that is placed over a probe of an ultrasonic diagnostic device, and to a covered ultrasonic diagnostic device that is covered with the probe cover. [Background technology]

[0002] As a device for visualizing the inside of a patient's body, an ultrasound diagnostic device such as that disclosed in Patent Document 1 is known. The ultrasound diagnostic device has a probe capable of transmitting and receiving ultrasound and a monitor housed in a casing. This ultrasound diagnostic device is used by placing the probe against the epidermis of the area to be visualized (i.e., the test area), and ultrasound is emitted from the probe. The emitted ultrasound is reflected by the test area, and the reflected waves are received by the probe. The ultrasound diagnostic device performs image processing based on the received reflected waves, and the image obtained by image processing, i.e., a cross-section of the test area, is displayed on the monitor. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Publication No. 2018-175548 Summary of the Invention [Problem to be solved by the invention]

[0004] In the ultrasound diagnostic device of Patent Document 1, a probe is covered with an elastic gel-like cover. This gel-like cover has a relatively large thickness and is flexible in the thickness direction, which has the advantage of providing good adhesion not only to the probe but also to uneven body surfaces. On the other hand, when imaging a subject through a flat body surface, if the force with which the ultrasound diagnostic device is pressed against the body surface is not constant during measurement, the thickness of the gel-like cover will change, causing a change in the distance between the probe and the subject. Therefore, there is still room for improvement in measurement accuracy.

[0005] Therefore, an object of the present invention is to provide a probe cover body for an ultrasound diagnostic device and an ultrasound diagnostic device with a cover that have high adhesion to the probe and flat body surface, thereby improving measurement accuracy. [Means for solving the problem]

[0006] The probe cover body of the present invention is a probe cover body to be placed over a probe in an ultrasonic diagnostic device which includes a casing and a probe which is arranged at one end of the casing in a predetermined direction and has a sensor which receives ultrasonic waves reflected by a test area, and which includes: a bracket which is attached to the casing and has an opening which faces the probe when attached to the casing; and a flexible cover film which is supported by the bracket and covers the opening, and the cover film has a thickness dimension of 10 μm or more and 60 μm or less, and a 50% modulus value of 10 MPa or less.

[0007] With this configuration, the thickness dimension is 10 μm or more and 60 μm or less, so the thickness dimension of the cover film varies little during measurement, improving measurement accuracy. Furthermore, since the 50% modulus value of the cover film is 10 MPa or less, it stretches significantly with a relatively small force, achieving high adhesion to the probe. Furthermore, since the cover film covers the probe in close contact without wrinkles, adhesion to the body surface during measurement is also high. [Effects of the Invention]

[0008] The probe cover and the covered ultrasonic diagnostic device according to the present invention provide high adhesion between the probe and the flat body surface, thereby improving measurement accuracy. [Brief explanation of the drawings]

[0009] [Figure 1] 1 is a front view showing a covered ultrasonic diagnostic apparatus in which a probe cover according to an embodiment of the present invention is attached to the ultrasonic diagnostic apparatus. [Figure 2]FIG. 2 is a front view showing a state in which the probe cover body is attached to the ultrasonic diagnostic apparatus. [Figure 3] FIG. 2 is a plan view of the probe cover body. [Figure 4] 4 is a cross-sectional view of the probe cover body of FIG. 3 taken along line IV-IV. [Figure 5] FIG. 4 is a side view of the probe cover body of FIG. 3. [Figure 6] FIG. 4 is an exploded cross-sectional view of the probe cover body of FIG. 3. DETAILED DESCRIPTION OF THE INVENTION

[0010] A probe cover and a covered ultrasonic diagnostic device according to an embodiment of the present invention will be described below with reference to the drawings. Note that the concept of directions used in the following description is used for convenience of explanation and does not limit the orientation of the configuration of the invention to those directions. Furthermore, the probe cover and the covered ultrasonic diagnostic device described below are merely one embodiment of the present invention. Therefore, the present invention is not limited to the following embodiment, and additions, deletions, and modifications to the configuration are possible within the scope of the invention.

[0011] The covered ultrasonic diagnostic device 1 shown in Figure 1 is used to insert a needle or the like while visualizing blood vessels or the like under the skin, for example, when placing a catheter in a blood vessel during dialysis treatment. The covered ultrasonic diagnostic device 1 having such functions comprises an ultrasonic diagnostic device 2 and an ultrasonic diagnostic device cover 3 that is placed over the ultrasonic diagnostic device 2. An example of the configuration of the ultrasonic diagnostic device 2 and the ultrasonic diagnostic device cover 3 will be described below.

[0012] <Ultrasound diagnostic equipment> The ultrasonic diagnostic device 2 is placed against the body surface and emits ultrasonic waves to the area to be examined (i.e., subcutaneous tissue) and receives ultrasonic waves reflected by the area to be examined (i.e., reflected waves). The ultrasonic diagnostic device 2 also performs image processing based on the received reflected waves and displays a cross section of the area to be examined. The ultrasonic diagnostic device 2 having such functions has a casing 11, a probe 12, and a monitor 13.

[0013] The casing 11 is made of synthetic resin, such as polycarbonate, ABS (acrylonitrile butadiene styrene) resin, SAS (silicon acrylonitrile styrene) resin, or polypropylene, and is a box-shaped body that is roughly rectangular in front view and has a flat cross section, as shown in FIG. 2. The lower portion 11a of the casing 11 is trapezoidal, tapering downward, and a probe 12 is disposed at the tip portion 11b, which is the lower end (one end in a predetermined direction) of the lower portion 11a. The casing 11 also has a curved portion midway in the vertical direction, and the upper portion is curved backward relative to the lower portion at this curved portion. Furthermore, a monitor 13 is disposed on the front surface 11c of the casing 11, and the monitor 13 displays images.

[0014] The probe 12 is configured to transmit and receive ultrasonic waves and includes a sensor 12a. The sensor 12a is composed of, for example, an acoustic lens, an acoustic matching layer, a transducer, and a backing material. As shown in FIG. 2, the sensor 12a is housed in the lower portion 11a of the casing 11 so that the lower end surface of the sensor 12a is flush with the tip portion 11b of the casing 11. The sensor 12a is connected to a control device (not shown) housed in the casing 11 and emits ultrasonic waves in response to commands from the control device. The sensor 12a receives waves reflected from the test area and outputs a signal corresponding to the received ultrasonic waves to the control device. That is, the transducer of the sensor 12a vibrates due to the waves reflected from the test area and outputs a signal corresponding to the vibration to the control device. The control device has an image processing function and performs image processing based on the received signals to output image data to the monitor 13.

[0015] The monitor 13 is an example of an image display unit, and may be, for example, a liquid crystal display or an organic EL display, which displays an image corresponding to the image data. Therefore, the monitor 13 is capable of displaying an image created based on the reflected waves received by the sensor 12a, such as a cross-section of the test area. As described above, the monitor 13 is disposed on the front surface 11c of the casing 11, and more specifically, on the front surface 11c of the casing 11 above the curved portion.

[0016] Such an ultrasonic diagnostic device 2 is used by scanning the probe 12 over the body surface of the subject. Therefore, when the ultrasonic diagnostic device 2 is not to be sterilized, the ultrasonic diagnostic device 2 is covered with an ultrasonic diagnostic device cover 3.

[0017] <Cover for ultrasound diagnostic equipment> The ultrasonic diagnostic apparatus cover 3 covers the entire ultrasonic diagnostic apparatus 2 to prevent blood and the like from adhering to the ultrasonic diagnostic apparatus 2. The ultrasonic diagnostic apparatus cover 3 includes a cylindrical body 21 and a probe cover body 22, and the probe cover body 22 further includes a guide-equipped bracket (bracket) 23 and a cover film 24.

[0018] The cylindrical body 21 is a sterile, soft body that has been sterilized and is made of a low-elasticity film. The cylindrical body 21 has a flat cross section, with the lower portion 21a formed in a trapezoidal shape that tapers downward, and the upper portion 21b formed in a trapezoidal shape that widens upward. The cylindrical body 21 is a highly transparent soft body made of a material such as polyethylene, polypropylene, polyethylene terephthalate, or polyvinyl chloride. Because the cylindrical body 21 is soft, it is easy to house the ultrasound diagnostic device 2 inside, and its high transparency makes it easy to view the monitor 13 of the ultrasound diagnostic device 2 housed inside from the outside.

[0019] 2, the ultrasonic diagnostic device 2 is inserted into the cylindrical body 21 with its upper portion 21b folded. This prevents the ultrasonic diagnostic device 2 from contacting the outer surface of the cylindrical body 21 during insertion and contaminating the outer surface. Furthermore, even after insertion, the opening of the upper portion 21b can be closed without the ultrasonic diagnostic device 2 coming into contact with the outer surface of the cylindrical body 21.

[0020] The guide-equipped bracket 23 of the probe cover body 22 has a bracket main body 31 and a guide portion 32. The bracket main body 31 is made of a relatively hard material, such as a synthetic resin such as polycarbonate, ABS (acrylonitrile butadiene styrene) resin, SAS (silicon acrylonitrile styrene) resin, or polypropylene. The bracket main body 31 is formed in a roughly plate-like shape when viewed from the front as shown in FIG. 1, and is formed in a horizontally elongated, flat, annular shape when viewed from above as shown in FIG. 3. For ease of explanation, the guide portion 32 is not shown in FIG. 3. The same applies to FIG. 5, which will be described later.

[0021] The bracket body 31 has an opening 31a, and the inner peripheral surface 31b defining this opening 31a is tapered so that the diameter of the opening decreases downward, as shown in FIG. 4 . The opening 31a is elongated from side to side, similar to the horizontal cross-sectional shape of the lower portion 11a of the casing 11. A portion of the tapered lower portion 11a (including the distal end portion 11b) can be inserted into the opening 31a. The inner peripheral surface 31b is shaped to be substantially parallel to (face directly opposite to) the outer peripheral surface of the lower portion 11a of the casing 11 when the lower portion 11a is inserted into the bracket body 31. To maintain the lower portion 11a of the casing 11 inserted into the bracket body 31, the bracket body 31 is provided with a pair of locking pieces 33.

[0022] As shown in FIGS. 4 and 5 , the pair of locking pieces 33 are plate-shaped members extending in the vertical direction and are integrally provided on the upper surface of the bracket main body 31. The pair of locking pieces 33 are arranged spaced apart on the left and right sides with their main surfaces facing each other. The pair of locking pieces 33 extend upward and inclined outward away from each other to match the side surface shape of the lower portion 11a of the casing 11, allowing the lower portion 11a of the casing 11 to be inserted between them. A locking hole 33a is formed in the main surface of each of the pair of locking pieces 33, and mating protrusions 11d (see FIG. 2 ) are formed on the left and right side surfaces of the lower portion of the casing 11 corresponding to the locking holes 33a. Therefore, when the casing 11 is inserted into the bracket main body 31 to a predetermined position, the mating protrusions 11d are fitted into the locking holes 33a. This secures and fixes the bracket main body 31 to the casing 11. At this time, the lower portion 11a of the casing 11 protrudes downward from the lower surface of the bracket body 31 by a predetermined distance.

[0023] 1 and 2, the bracket main body 31 is provided at the lower end opening 21c of the lower portion 21a of the cylindrical body 21. More specifically, the inner peripheral surface of the lower end opening 21c of the cylindrical body 21 is welded to the outer peripheral surface of the bracket main body 31, thereby being liquid-tightly connected around the entire circumference. Furthermore, a cover film 24 is supported on the bracket main body 31, and the cover film 24 covers the opening 31a.

[0024] The cover film 24 has a generally horizontally elongated rectangular shape in a plan view, is slightly larger than the opening 31a of the bracket main body 31, and is flexible (the cover film 24 will be described further below). In order to support the cover film 24, the bracket main body 31 is made up of two upper and lower members, namely, a first bracket portion 34 and a second bracket portion 35, as shown in FIG.

[0025] The first bracket portion 34 and the second bracket portion 35 are both horizontally elongated, flat, and annular in plan view, and are formed to have substantially the same shape. The first bracket portion 34 has the pair of locking pieces 33 formed on its upper surface, and the first bracket portion 34 is placed on the second bracket portion 35 with its lower surface abutting against the upper surface of the second bracket portion 35. The outer peripheral surface of the first bracket portion 35 is provided with a plurality of engagement portions spaced apart in the circumferential direction, and each engagement portion has an engagement hole 34a formed therein. The outer peripheral surface of the second bracket portion 35 has a plurality of engagement protrusions 35a formed therein corresponding to the engagement holes 34a. Therefore, when the first bracket portion 34 and the second bracket portion 35 are placed one on top of the other, the engagement protrusions 35a fit into the engagement holes 34a, and the two bracket portions 34, 35 are locked to each other (see FIG. 4).

[0026] A recess 35b is formed on the inner periphery of the upper surface of the second bracket portion 35. The recess 35b is formed around the entire circumferential edge of the inner periphery of the second bracket portion 35 and is recessed downward relative to the remaining portion. Therefore, when the first bracket portion 34 and the second bracket portion 35 are overlapped, the recess 35b forms a storage space 31d around the entire circumferential edge of the inner periphery of the bracket main body 31. The storage space 31d is a space recessed outward from the inner periphery 31b, and the outer periphery of the cover film 24 can be accommodated therein. That is, by placing the outer periphery of the cover film 24 in the recess 35b and attaching the first bracket portion 34 to the second bracket portion 35, the outer periphery of the cover film 24 is sandwiched between the two bracket portions 34, 35. In this manner, the cover film 24 is fixed to the bracket main body 31 and, in the fixed state, blocks the opening 31a. As a result, the cover film 24 is provided on the cylindrical body 21 via the bracket main body 31 so as to close the lower opening 21c of the cylindrical body 21.

[0027] Additionally, a lower protrusion 35c is formed around the entire circumferential circumference of the recess 35b. The lower protrusion 35c is formed in an annular shape surrounding the opening 31a in plan view to match the shape of the recess 35b, and protrudes upward toward the lower surface of the first bracket portion 34. An upper protrusion 34c is also formed on the lower surface of the first bracket portion 34, corresponding to the lower protrusion 35c. The upper protrusion 34c is formed in an annular shape in plan view to match the shape of the lower protrusion 35c, and protrudes downward toward the upper surface of the second bracket portion 35. These two protrusions 34c, 35c are formed so that their tips substantially abut each other, and the outer edge of the cover film 24 is sandwiched between the protrusions 34c, 35c, allowing for strong clamping and holding.

[0028] As shown in FIG. 1, the bracket main body 31 is provided with a guide portion 32. The guide portion 32 guides a needle 41 (see the two-dot chain line in FIG. 1) of a needle assembly such as an indwelling needle and determines the puncture direction when the needle 41 is inserted into subcutaneous tissue, and is formed in a roughly trapezoidal block shape in side view. The guide portion 32 is provided on the front side of the cylindrical body 21 (i.e., on the monitor 13 side when the ultrasound diagnostic device 2 is housed inside the cylindrical body 21). This allows the patient to perform the puncture while watching the monitor 13 of the ultrasound diagnostic device 2. Furthermore, since the distance from the guide portion 32 to the sensor 12a is short, the puncture length can be shortened, improving the stability of the puncture operation and reducing the burden on the patient.

[0029] The guide portion 32 has a forward-inclined front end surface 32a, and a guide hole-forming portion 32b is formed in the left-right center of the front end surface 32a. The guide hole-forming portion 32b protrudes perpendicular to the front end surface 32a and extends vertically along the front end surface 32a. The cross section of the guide hole-forming portion 32b (i.e., the cross section perpendicular to the front end surface 32a) is formed in a substantially semicircular shape, and a guide hole 32c is formed in the guide hole-forming portion 32b along its axis. This results in the guide hole 32c extending diagonally upward and forward in the guide portion 32. That is, the guide hole 32c penetrates the guide portion 32 diagonally upward and forward, allowing the needle 41 to be inserted from the upper side and the needle tip 41a to be ejected from the lower side. An extraction opening 32d extending along the axis of the guide hole 32c is formed in the front surface of the guide hole-forming portion 32b, and the needle 41 can be removed by tilting it forward through the guide hole-forming portion 32b.

[0030] <Installation work> The ultrasonic diagnostic device cover 3 is placed in a bag such as a sterile pack (not shown) to maintain a sterile state, and is removed from this sterile pack when in use. The removed ultrasonic diagnostic device cover 3 has the upper portion 21b of the tubular body 21 pre-folded as shown in Figure 2, and the user inserts their finger from below into the valley of the folded upper portion 21b to open the tubular body 21. The ultrasonic diagnostic device 2 is inserted into this opening, tip first.

[0031] Next, when the ultrasonic diagnostic device 2 is pushed into the cylindrical body 21, the tip of the ultrasonic diagnostic device 2 enters the opening 31a of the bracket main body 31, and the tip then abuts against the cover film 24. When the ultrasonic diagnostic device 2 is further pushed in from this state, the cover film 24 expands to fit the shape of the tip of the ultrasonic diagnostic device 2, and the tip of the ultrasonic diagnostic device 2 protrudes downward from the bracket main body 31. When the ultrasonic diagnostic device 2 is continued to be pushed in this state, the pair of fitting protrusions 11d come into contact with the corresponding locking pieces 33 and fit into the locking holes 33a, and the ultrasonic diagnostic device 2 is attached to the bracket main body 31 (see FIG. 1).

[0032] <Cover film> Incidentally, high adhesion of the probe 12 to the body surface is required for measurement of the area to be examined using the ultrasound diagnostic device 2. As described above, the ultrasound diagnostic device 2 is used while housed in the ultrasound diagnostic device cover 3, and therefore high adhesion is also required between the cover 3 and the probe 12. Furthermore, in order to suppress attenuation of ultrasound during use and increase measurement accuracy, it is preferable that the distance from the probe 12 to the area to be examined is short.

[0033] From this viewpoint, in this embodiment, the cover film 24 covering the probe 12 has a thickness of 10 μm or more and 60 μm or less, and a 50% modulus value of 10 MPa or less.

[0034] Here, by setting the thickness dimension of the cover film 24 to 10 μm or more and 60 μm or less, the distance from the probe 12 to the test area can be reduced, thereby improving measurement accuracy. Furthermore, even when the ultrasound diagnostic device 2 is pressed against the body surface during use, the thickness of the cover film 24 has a small variable range, thereby further improving measurement accuracy. Furthermore, by setting the 50% modulus value of the cover film 24 to 10 MPa or less, the cover film 24 is greatly elongated with a relatively small force, thereby achieving high adhesion to the probe 12. Furthermore, by fitting the cover film 24 tightly over the probe 12 without wrinkles, adhesion to the body surface during measurement is also high.

[0035] Furthermore, the 50% modulus value of the cover film 24 is more preferably 6 MPa or less. This allows the cover film 24 to conform to the outer surface shape of the probe 12 and fit well, achieving high adhesion. The "50% modulus value" refers to the measured value (maximum value) of the stress per unit width dimension of the test piece required to stretch the film of the test piece by 50% in the longitudinal direction (i.e., to a length 1.5 times the original length).

[0036] Such a cover film 24 may be made of, for example, POLYGRACE NEO (product name "PG-NEO") or POLYGRACE-V (product name "PG-V") ("POLYGRACE" is a registered trademark), which are polyolefin-based films manufactured by Takeda Sangyo Co., Ltd.

[0037] The material of the cover film 24 is not limited to polyolefin-based materials. Films made of other materials can also be used as long as they can achieve the thickness and 50% modulus values ​​described above. Considering the ease of attaching the ultrasound diagnostic device 2 to the ultrasound diagnostic device cover 3 and the need to prevent wrinkles from forming on the cover film 24 during attachment, it is more preferable that the cover film 24 have low tackiness (adhesiveness) on its surface. From this perspective, more specifically, it is preferable that the adhesiveness of the surface of the cover film 24 be 0.02 N / 25 mm or less.

[0038] In the above description, the cylindrical body 21 and the cover film 24 are made of different materials, but they may be made of the same material. Furthermore, the cover film 24 is not limited to being supported by being sandwiched between the bracket main body 31, and other support modes are also possible, such as being connected by welding to the outer or inner peripheral surface of the bracket main body 31. [Explanation of symbols]

[0039] 1. Ultrasound diagnostic device with cover 2. Ultrasound diagnostic equipment 3 Ultrasound diagnostic equipment cover 11 Casing 12 probes 12a Sensor 21 Cylindrical body 22 Probe cover body 23 Guided Bracket 24 Cover film 31 Bracket body 31a aperture

Claims

1. 1. A probe cover for an ultrasonic diagnostic apparatus including a casing and a probe having a sensor disposed at one end of the casing in a predetermined direction and receiving ultrasonic waves reflected by a test area, the probe cover comprising: a bracket attached to the casing and having an opening facing the probe when attached to the casing; a flexible cover film supported by the bracket to cover the opening and against which the probe and a body surface come into contact; When the bracket is attached to the casing, the cover film stretches to fit the shape of the one end of the casing protruding from the opening, has a thickness of 10 μm or more and 60 μm or less, and a 50% modulus value of 6 MPa or less. Probe cover body.

2. A probe cover body as described in claim 1, wherein the cover film has a surface adhesiveness of 0.02 N / 25 mm or less.

3. A covered ultrasonic diagnostic device comprising the probe cover body according to claim 1 or 2 and the ultrasonic diagnostic device.

Images