JP7197564B2 - medical device - Google Patents

Description

The present invention relates to medical devices.

Conventionally, various medical elongated bodies (for example, medical devices such as introducers) are introduced into the blood vessel through a puncture site formed in the blood vessel of the patient's arm, and a procedure is performed to treat or treat the lesion site. Are known. When such a procedure is performed, the operator stops bleeding at the puncture site when removing the medical elongate body from the puncture site.

A hemostatic device used to stop bleeding at a puncture site includes a band for wrapping around a limb such as an arm, a fixing means for fixing the band while the band is wrapped around the limb, and connected to the band for injecting a fluid. and a pressing portion that expands by pressing and presses the puncture site (see Patent Document 1).

JP 2008-119517 A

The radial artery that runs in the arm of the human body is connected to the palmar artery that bypasses the hand (for example, the radial artery around the snuff box and the distal radial artery that runs on the fingertip side of the snuff box). Therefore, for example, by forming a puncture site in the palmar artery, the operator can insert the medical elongated body into the radial artery running on the arm side. In addition, if the puncture site is formed on the hand instead of the arm or wrist, the patient may move the arm while hemostasis is being performed (while applying pressure to the puncture site). Since it becomes possible, the freedom of movement of the body increases, and QOL (quality of life) improves.

Tendons and bones are gathered around the palmar artery, and it is necessary to avoid the tendons and bones when puncturing. However, when puncturing while avoiding tendons and bones, puncturing cannot be performed at an accurate position unless there is a guideline for the puncturing position. If the puncture position is misaligned, there is a possibility that not only the front side of the blood vessel but also the back side of the blood vessel will be unintentionally punctured when the needle is punctured.

SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a medical device that enables accurate positioning of the puncture position for the palmar artery.

A medical device according to the present invention that achieves the above object is provided with a first detection unit that detects the blood pressure of a subject from the surface layer of the skin, and is spaced apart from the first detection unit by a predetermined distance, A second detection unit that detects the blood pressure of the subject from the skin surface side at a position different from the first detection unit, and a detection result of the first detection unit and a detection result of the second detection unit. an output unit for outputting; and a guide unit for guiding a needle tip of a puncture device to be punctured by the subject between the first detection unit and the second detection unit , wherein the output The part has a display part that displays the pressure distribution in the direction intersecting with the running blood vessel.

According to the medical device of the present invention, the detection result of the first detection section and the detection result of the second detection section are output to the output section. Further, when puncturing the palmar artery, the needle tip of the puncture device can be guided to a desired position by the guide section, so that the puncture site can be formed at an accurate position.

It is a figure which shows a mode that the medical device which concerns on embodiment of this invention was mounted on the hand of the subject. 1 is a schematic perspective view of a medical device according to an embodiment of the invention; FIG. FIG. 3 is a diagram showing how a puncture site is formed using the medical device and the puncture instrument shown in FIG. 2; Figure 3 shows an output section of the medical device shown in Figure 2; FIGS. 5(A) and 5(B) are diagrams showing how the puncture site is formed by the puncture device. 1 is a transverse cross-sectional view of a needle assembly according to an embodiment of the invention; FIG. FIG. 4 is a diagram showing a puncture site formed on the body surface;

Hereinafter, embodiments of the present invention will be described with reference to the attached drawings. The following description does not limit the technical scope or the meaning of terms described in the claims. Also, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from the actual ratios.

In the description of this specification, the direction in which the support bases 41 and 42 of the medical device 100 are arranged is referred to as the "length direction X". Further, the width direction of each of the output sections 30A and 30B and the guide section 40 included in the medical device 100 is referred to as "width direction Y". Moreover, the height direction orthogonal to the length direction X and the width direction Y is described as "height direction Z."

(First embodiment)
1 to 7 are diagrams for explaining a medical device 100 according to an embodiment of the present invention.

The medical device 100 is the radial artery of the palmar artery (deep palmar artery) B that runs through the back of the hand Hb of the subject's (patient's) hand H (for example, the radial artery around the snuff box and the snuff box that runs on the fingertip side). It is used to form a puncture site t1 at a desired position on the back Hb of the hand when introducing a medical elongate body such as a catheter or introducer from the distal radial artery, etc.). The position where the puncture site t1 is formed is not particularly limited as long as it is a position where the medical elongate body can be inserted into the palmar artery B running through the hand H, and any position such as the left hand, the right hand, the back side of the hand, the palm side, etc. may be the part of

The medical device 100 according to this embodiment, as shown in FIG. It has a needle assembly (corresponding to a “puncture device”) 50 .

(First detection unit, second detection unit)
The first detection unit 10 and the second detection unit 20 detect the blood pressure of the subject from the surface layer side of the skin. The first detection section 10 includes a pressure sensor 11 and a support 12 . The pressure sensor 11 is configured to detect the blood pressure of the subject at regular intervals in the width direction Y of the supports 41 and 42 of the guide section 40 .

The support 12 is arranged adjacent to the pressure sensor 11 and further away from the subject's skin than the pressure sensor 11 . The pressure sensor 11 can be configured by, for example, a known sheet-type pressure-sensitive sensor.

The support 12 is made of a flexible material so that the first detection unit 10 can be flexibly deformed according to the attachment site of the subject. Examples of the material of the support 12 include polyurethane and urethane-based elastomer.

The second detection unit 20 is arranged apart from the first detection unit 10 by a predetermined distance in the length direction X, and detects the blood pressure of the subject from the skin surface side at a position different from the first detection unit 10. To detect. The second detection unit 20 includes a pressure sensor 21 and a support 22 as shown in FIG. The pressure sensor 21 is the same as the pressure sensor 11 of the first detection section 10, and the support 22 is the same as the support 12 of the first detection section 10, so description thereof will be omitted.

(output section)
As shown in FIG. 2, the support base 41 is provided with the first output section 30A. The first output section 30A outputs the detection result of the first detection section 10 .

A second output section 30B is arranged on the support base 42 . A second output unit 30B outputs the detection result of the second detection unit 20 . Since the first output section 30A and the second output section 30B have substantially the same configuration, the first output section 30A will be described, and the description of the second output section 30B will be omitted as appropriate.

30 A of 1st output parts are provided with the display part 31 and the instruction|indication part 32, as shown in FIG.

The display unit 31 is configured to visually display the pressure distribution in the direction intersecting the running blood vessel as the detection result of the first detection unit 10 on the support base 41 . As shown in FIG. 4, the display unit 31 displays the pressure values detected by the pressure sensor 11 of the first detection unit 10 as an example of a histogram without numerical values. The display unit 31 is configured to display the pressure detection result at each predetermined interval in the width direction Y of the support base 41 constituting the guide unit 40 . By configuring in this way, it is possible to grasp which position in the width direction Y of the support base 41 the palmar artery B is close to. The display unit 31 is provided on the support base 42 as well as the support base 41 . The display unit 31 may be configured to display the detected pressure using numerical values, symbols, characters, combinations thereof, or the like.

The indicating section 32 is configured to display the center position of the display section 31 in the width direction Y of the support base 41 . As shown in FIG. 4, the indicator 32 is indicated by a substantially upward triangular mark in the lower portion of the display 31 in this embodiment.

The second output section 30B displays the pressure detection result at each predetermined interval in the width direction Y of the support base 42 . Also, the indicator 32 of the second output section 30B displays the center position of the display section 31 in the width direction Y of the support base 41 .

(Guide part)
The guide portion 40 moves between the first detection portion 10 and the second detection portion 20 (substantially the center position between the first detection portion 10 and the second detection portion 20 in the length direction X), It guides the tip of the needle assembly 50 to be punctured by the subject. The guide part 40 includes support bases 41 and 42 and rod-like members 43 and 44 as shown in FIG.

The support base 41 is attached to the top of the first detection unit 10 in the height direction Z. As shown in FIG. The support base 41 is configured to have a concave guide groove 41a on which the needle tip of the needle assembly 50 is placed, as shown in FIG. As shown in FIG. 3, the medical device 100 is aligned with the subject by the first detection unit 10, the second detection unit 20, the first output unit 30A, and the second output unit 30B. By placing the needle portion of the needle assembly 50 in the guide groove 41a, the palmar artery B to be punctured can be punctured while being visually observed. In addition, by providing an inclination to the guide groove 41a, the needle portion of the needle assembly 50 placed on the guide groove 41a is inclined, for example, by 30 degrees from the horizontal plane, and the needle tip is at an angle suitable for puncture. be able to. In addition, it is possible to puncture along the running direction of the palmar artery B and aim at substantially the center of the palmar artery B.

The support base 42 is attached to the top of the second detection section 20 . The support base 42 is spaced from the support base 41 in the longitudinal direction X to guide the tip of the needle portion of the needle assembly 50 between the support bases 41 and 42 . The distance d between the support base 41 and the support base 42 is such that the guide groove 41a is formed so that the needle assembly 50 is inserted at an angle of about 30 degrees, and the needle assembly 50 is inserted at a depth of about 2 mm from the body surface. If so, it can be set to 5 mm to 10 mm.

As shown in FIG. 2, the rod-like members 43 and 44 are configured to connect the supports 41 and 42 spaced apart in the longitudinal direction X. As shown in FIG. The bar members 43 and 44 are provided with a predetermined space in the width direction Y between the support bases 41 and 42 so that the needle tip of the needle assembly 50 can be guided between the support bases 41 and 42 . are placed.

(needle assembly)
The needle assembly 50 includes an inner needle 51 and an outer tubular tube 52, as shown in FIG. The tips of the inner needle 51 and the outer cylindrical tube 52 are formed in a substantially rectangular shape as shown in FIG. As a result, the wound at the time of puncture (the shape of the puncture site t1 in a plan view) can be formed in a shape extending along the running direction of the palmar artery B as shown in FIG. Since blood vessels generally have stretchability, even when a wound is formed along the running direction of the palmar artery B, the elongated body for medical use having a substantially circular cross section can be smoothly passed through. can be done. In addition, it can be expected that the wound formed by the inner needle 51 acts in a direction to naturally close after the medical elongate body is removed. In addition, the method of forming the puncture site t1 as described above does not force the wound open, so that the wound can be easily closed.

As shown in FIG. 6, recesses 53a and 53b are formed on the outer surface of the inner needle 51 to form a blood flow path between the inner needle 51 and the outer cylindrical tube 52 when inserted into the outer cylindrical tube 52. As shown in FIG. In this embodiment, recesses 53a and 53b are provided at two different positions in the height direction of the inner needle 51 (vertical direction in FIG. 6). When puncturing is performed using the inner needle 51 and the outer cylindrical tube 52, blood from the palmar artery B circulates through the recesses 53a and 53b by capillary action. Since the recesses 53a and 53b are arranged at different positions in the height direction of the inner needle 51, the operator can confirm through which recesses 53 and 53b the blood is flowing, thereby assembling the needle assembly. It is possible to grasp how deep the palmar artery B is punctured by 50 . This reduces the risk of unintentional double-wall puncture, and allows the palmar artery B to be captured by a single-wall puncture (puncture of only the vascular wall on the front side of the body surface of the palmar artery B).

In addition, the outer surface of the inner needle 51 may be subjected to pruning or texturing in order to prevent the inner needle 51 from adhering to the skin.

(Example of use)
Next, a usage example of the medical device 100 according to this embodiment will be described.

The operator places the medical device 100 near the palmar artery B of the hand H as shown in FIG. The detection result of the unit 20 is displayed on the second output unit 30B.

Next, the operator adjusts the position of the medical device 100 so that the pressure distribution indicated by the first output section 30A and the pressure distribution indicated by the second output section 30B are substantially the same. At this time, the operator sees the pressure distribution displayed on the first output unit 30A outputting the detection result of the first detection unit 10 and the second output outputting the detection result of the second detection unit 20. The pressure distribution displayed on the part 30B is visually confirmed, and the orientation of the medical device 100 and the like are adjusted so as to follow the running of blood vessels of the subject.

After completing the above operations, the operator performs puncture using the needle assembly 50 . At this time, as shown in FIG. 3, puncturing is performed considering that the positions to be inserted into the palmar artery B and the positions to be inserted into the body surface are changed in the longitudinal direction X. Further, while confirming the pressure distribution indicated by the first output section 30A and the pressure distribution indicated by the second output section 30B, the operator can Set the puncture location to the location.

At the time of puncturing, a needle assembly 50 shown in FIG. 6 is used to form a wound shaped along the running direction of the palmar artery B as shown in FIG.

When the needle assembly 50 is punctured into the palmar artery B, blood flows through the recess 53a of the needle assembly 50, which is located on the lower side at the time of puncture, by capillary action. If the needle tip is further advanced from there, reverse blood can also be seen in the concave portion 53b positioned above at the time of puncture. Thus, it can be confirmed that the distal end of the outer cylindrical tube 52 has secured the inside of the palmar artery B. As shown in FIG. After confirming reverse blood, the operator pulls out the inner needle 51 while leaving the outer tubular tube 52 .

Next, insert the introducer into the palmar artery B. Since the vascular wall is stretchable, the wound formed in the palmar artery B has a nearly circular shape to match the introducer. Therefore, the wall surface of the palmar artery B is not further expanded, or is hardly expanded.

After treatment such as treatment is completed, the introducer is removed from the palmar artery B. The stretchability of the palmar artery B can be expected to act in the direction of natural closing of the puncture site t1. In addition, if the medical device 100 according to the present embodiment is used, the wound is not forcibly widened, so the state of the tissue is relatively clean, and the wound is easily closed.

As described above, the medical device 100 according to the present embodiment includes the first detection unit 10 that detects the blood pressure of the subject from the surface layer side of the skin, and the first detection unit 10 is separated from the first detection unit 10 by a predetermined distance. A second detection unit 20 arranged to detect the blood pressure of the subject from the skin surface side at a position different from the first detection unit 10, and the detection result of the first detection unit 10 and the second detection unit 20 and output units 30A and 30B for outputting the detection results, and a guide unit for guiding the needle tip of the needle assembly 50 to be punctured by the subject between the first detection unit 10 and the second detection unit 20. 40 and .

The medical device 100 can output the detection result of the first detection unit 10 and the detection result of the second detection unit 20 to the output units 30A and 30B. Then, when puncturing the palmar artery B, the operator can use the guide part 40 to guide the needle tip of the needle assembly 50 to a desired position. Therefore, the operator can form the puncture site t1 at an accurate position. In addition, since the puncture needle is usually punctured at an angle with respect to the puncture site, the puncture position on the body surface and the puncture position on the blood vessel are slightly shifted in the longitudinal direction of the upper limb or the like. Furthermore, when a long body for medical use is inserted from the palmar artery, the tendons, etc., are intricately approaching the area around the palmar artery. may be incomplete. On the other hand, by using the medical device 100 according to the present embodiment, it is possible to reliably press the bleeding site by accurately detecting the puncture position.

Moreover, the output units 30A and 30B are configured to have a display unit 31 that displays the pressure distribution in the direction intersecting the running blood vessel, and an instruction unit 32 that instructs the central position of the display unit 31 . Therefore, the medical device 100 can be aligned with the subject so that the needle assembly 50 can be punctured in line with the course of the blood vessel.

Also, the first detection unit 10 and the second detection unit 20 are configured to have flexible supports 12, 22 on which the pressure sensors 11, 21 are arranged. Therefore, the medical device 100 can be placed along the body surface of the hand H of the patient.

The medical device 100 also has a needle assembly 50 with an inner needle 51 and an outer tubular tube 52 housing the inner needle 51 . The tip of the inner needle 51 is configured to have a rectangular shape. By configuring in this manner, the wound can be prevented from being forcibly widened when the puncture site t1 is formed with the needle assembly 50, and the wound can be easily closed.

In addition, the inner needle 51 is configured to have a concave portion 53 forming a blood flow path between itself and the outer cylindrical tube 52 in a state of being inserted into the outer cylindrical tube 52 . Therefore, it is possible to estimate how much the palmar artery B has been punctured by the needle assembly 50 based on blood flowing from the concave portion 53 by capillary action when the needle assembly 50 is punctured. As a result, the risk of double-wall puncture can be reduced and the palmar artery B can be captured even with a single-wall puncture.

It should be noted that the present invention is not limited to the above-described embodiments, and various modifications can be made within the scope of the claims. It has been described above that the pointing section 32 indicates the central position of the display section 31 . However, as long as the medical device 100 can be aligned along the running blood vessel of the subject, the position indicated by the indicator does not have to be the central position of the display.

Further, it has been described above that the indication unit 32 is configured by a substantially triangular mark, and the medical device 100 is aligned by aligning the pressure distribution displayed on the display unit 31 with the mark on the indication unit 32 . However, if the medical device 100 can be aligned with the subject's palmar artery B, the present invention is not limited to this. may be configured to notify the user that alignment has been performed by

This application is based on Japanese Patent Application No. 2018-068192 filed on March 30, 2018, the disclosure of which is incorporated by reference in its entirety.

100 medical devices;
10 first detection unit,
11, 21 pressure sensor,
12, 22 support,
20 second detector,
30A first output section (output section),
30B second output section (output section),
53a, 53b recesses,
40 guide part,
41a guide groove,
50 needle assembly (puncture device),
51 inner needle,
52 outer tube,
H hand,
Hb back of hand,
B palmar artery,
t1 puncture site.

Claims (5)

a first detection unit that detects the blood pressure of the subject from the skin surface side;
A second detection unit that is arranged at a predetermined distance from the first detection unit and detects the blood pressure of the subject from the surface layer side of the skin at a position different from the first detection unit;
an output unit that outputs the detection result of the first detection unit and the detection result of the second detection unit;
a guide section that guides a needle tip of a puncture device to be punctured into the subject between the first detection section and the second detection section ;
The medical device , wherein the output unit has a display unit that displays the pressure distribution in the direction intersecting with the running blood vessel . The medical device according to claim 1 , wherein the output section has an indication section that indicates a center position of the display section. 3. The medical device of claim 1 or 2, wherein the first sensing portion and the second sensing portion comprise flexible supports on which pressure sensors are arranged. further comprising a needle assembly including an inner needle and an outer tube housing the inner needle;
The medical device according to any one of claims 1 to 3, wherein the needle tip of said inner needle has a rectangular shape. 5. The medical device according to claim 4, wherein the inner needle has a recess that forms a blood flow path between itself and the inner surface of the outer cylindrical tube in a state of being inserted into the outer cylindrical tube.

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