puncture device

Abstract

The present invention provides a puncture device that can securely attach a sensor unit to the surface of a living organism. [Solution] A puncture device comprising a housing, a vertically movable operating body, a sensor unit having an elongated sensor and an attachment portion to be attached to a biological surface, a needle holder integrally holding a puncture needle and allowing the puncture needle to rise from a puncture position housing the sensor to a withdrawal position, a sensor unit holder integrally holding the sensor unit in an initial state, a spring, and an operation restricting portion that restricts the downward movement of the operating body, wherein the sensor unit holder releases the restriction when the housing is pressed against the spring after the puncture needle is inserted into a biological surface and the attachment portion is attached to the biological surface, the operating body engages with the needle holder when pressed against the spring in the released state, and the needle holder rises to the withdrawal position when the pressing operation is released.

Description

Technical Field

[0001] The present disclosure relates to a puncture device.

Background Art

[0002] There is known a puncture device having a sensor unit having a sensor extending in a long shape and an attachment portion attached to a living body surface, and a needle holder integrally holding a puncture needle. After the puncture needle and the sensor are inserted into the living body surface with the puncture needle accommodating the sensor and the attachment portion is attached, the needle holder rises in a direction away from the living body surface to remove the puncture needle and separate it from the sensor, thereby disposing the sensor unit on the living body surface (see, for example, Patent Document 1).

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] In the puncture device as described above, when removing the puncture needle, an upward frictional force acts on the sensor unit from the needle holder as the needle holder rises. Therefore, if the attachment portion of the sensor unit is not firmly attached to the living body surface, there is a risk that the attachment state of the sensor unit to the living body surface becomes unstable after the puncture needle is removed.

[0005] Therefore, an object of the present disclosure is to provide a puncture device capable of firmly attaching a sensor unit to a living body surface.

Means for Solving the Problems

[0006] One aspect of the present disclosure is as follows.

[0007] [1] A housing, and An operating body that can move up and down relative to the housing between a pre-operation position and a post-operation position lower than the pre-operation position, A sensor unit having a sensor that extends in a long length downward and an attachment portion that is attached to a biological surface, The needle holder integrally holds the puncture needle having the downward-facing needle tip, and the puncture needle can be raised from the puncture position where it houses the sensor to the withdrawal position where it detaches from the sensor, and the needle holder is in the puncture position in the initial state before operation of the operating body, In the initial state, the sensor unit is held integrally, and the sensor unit holder is capable of rising from the pre-press position to the post-press position relative to the housing, A spring that generates a biasing force to raise the operating body relative to the sensor unit holder, It has an operation restricting unit that restricts the downward movement of the operating body from the pre-operation position, The sensor unit holder moves from the pre-press position to the post-press position when, after the initial state in which the puncture needle and the sensor are inserted into the biological surface and the adhesive portion is attached to the biological surface, the housing is pressed down against the biasing force of the spring along with the operating body, thereby releasing the restriction of the operating restriction portion. A puncture device wherein the operating body engages with the needle holder by elastic deformation when pressed against the biasing force of the spring in the release state where the restriction of the operating restraining part is released, and rises to the pre-operation position by the biasing force of the spring when the pressing operation is released, thereby raising the needle holder to the withdrawal position.

[0008] [2] The aforementioned operation restricting unit can be released by elastically deforming the restriction on the operating body. The puncture device according to [1], wherein the sensor unit holder restricts the elastic deformation of the operation restricting portion only when it is in the pre-press position among the pre-press position and the post-press position.

[0009] [3] The sensor unit holder can be released from its hold on the sensor unit by elastic deformation. The puncture device according to [1] or [2], wherein the needle holder restricts the elastic deformation of the sensor unit holder only when it is in the puncture position among the puncture position and the withdrawal position.

[0010] [4] The housing has an outer periphery wall and a top wall connected to the outer periphery wall. The puncture device according to any one of [1] to [3], wherein the operating body has a button portion that penetrates the top wall portion and protrudes upward in the initial state.

[0011] [5] The aforementioned operating restriction section is composed of a restricting piece extending downward from the top wall section. The restricting piece can be released by elastically deforming the restriction of the operating restricting part radially outward. The puncture device according to [4], wherein the sensor unit holder supports the restricting piece from the radially outer side only when it is in the pre-indentation position, of the pre-indentation position and the post-indentation position.

[0012] [6] The sensor unit holder has a retaining piece that can be released from the sensor unit by elastically deforming radially outward, The puncture device according to any one of [1] to [5], wherein the needle holder supports the retaining piece from the radially outer side only when it is in the puncture position among the puncture position and the withdrawal position.

[0013] [7] In the initial state, it has a withdrawal restricting unit that restricts the upward movement of the needle holder from the puncture position to the withdrawal position, The puncture device according to any one of items [1] to [6], wherein the operating body releases the restriction of the withdrawal restriction when the pressing operation is performed.

[0014] [8] The removal restricting part is constituted by a removal restricting piece provided on the sensor unit holder, In the initial state, the removal restricting piece engages with the needle holder, The puncturing device according to [7], wherein the operating body is pressed to elastically deform the removal restricting piece in the radial direction to release the restriction of the removal restricting part.

[0015] [9] The housing restricts the sensor unit holder from descending from the pre-pushing position by engaging with the sensor unit holder when the sensor unit holder descends from the pre-pushing position in the initial state, the puncturing device according to any one of [1] to [8].

[0016]

[10] The housing restricts the sensor unit holder from descending from the post-pushing position by engaging with the sensor unit holder when the sensor unit holder ascends from the pre-pushing position to the post-pushing position, the puncturing device according to any one of [1] to [9].

[0017]

[11] The housing restricts the needle holder from descending from the removal position by engaging with the needle holder when the needle holder ascends from the puncturing position to the removal position, the puncturing device according to any one of [1] to

[10] .

Advantages of the Invention

[0018] According to the present disclosure, it is possible to provide a puncturing device capable of firmly attaching a sensor unit to the living body surface.

Brief Description of the Drawings

[0019] [Figure 1] It is a cross-sectional view showing a puncturing device according to an embodiment of the present disclosure. [Figure 2] It is a bottom perspective view showing the puncturing device of FIG. 1 with the cap omitted. [Figure 3] It is a bottom perspective cross-sectional view of the housing of FIG. 2. [Figure 4] This is a cross-sectional view showing the state when the puncture needle and sensor are inserted subcutaneously using the puncture device shown in Figure 1. [Figure 5] This is a cross-sectional view showing the state when the housing and operating parts are pressed down from the state shown in Figure 4. [Figure 6] This is a cross-sectional view showing the state after pressing the control unit from the state shown in Figure 5. [Figure 7] This is a cross-sectional view showing the state after the pressing operation is released from the state shown in Figure 6 and the puncture needle is removed. [Figure 8] This is a cross-sectional view showing the state after the puncture device has been detached from the biological surface, leaving the sensor unit and needle cover intact, from the state shown in Figure 7. [Figure 9] This is a cross-sectional view showing the state after the needle cover has been detached from the biological surface, as shown in Figure 8. [Modes for carrying out the invention]

[0020] The embodiments of this disclosure will be described in detail below with reference to the drawings.

[0021] A puncture device 1 according to one embodiment of this disclosure comprises a sensor unit 2 having a sensor 2a and an attachment portion 2b1, which is placed on the biological surface 3, where the sensor 2a is inserted subcutaneously from the biological surface 3, which is the surface of the body, and the attachment portion 2b1 is attached to the biological surface 3. The sensor unit 2 placed on the biological surface 3 acquires biological information obtained through the sensor 2a. The biological information is obtained by processing signals such as electrical signals or optical signals obtained from the sensor 2a with a processing device. The processing device may be integrated into the sensor unit 2 or provided separately from the sensor unit 2. The device including the processing device may be attached to the sensor unit 2 while it is placed on the biological surface 3. The biological information is not particularly limited, and in this embodiment, it is blood glucose level. The puncture device 1 of this embodiment is particularly suitable for use as a puncture device 1 for a CGM (Continuous Glucose Monitoring Device). In this embodiment, the biological surface 3 is skin, and the body is a human.

[0022] As shown in Figures 1-9, the puncture device 1 according to this embodiment includes a housing 4, an operating body 5 that can move up and down relative to the housing 4 between a pre-operation position (see Figures 1, 4-5, 7-8) and a post-operation position lower than the pre-operation position (see Figure 6), a sensor unit 2 having a sensor 2a that extends downward and an attachment part 2b1 that is attached to the biological surface 3, and a puncture needle 6a with a downward-facing needle tip that is integrally held, and the puncture needle 6a detaches from the sensor 2a from the puncture position (see Figures 1, 4-6) where the sensor 2a is housed. The device includes a needle holder 6 that can be raised to the extraction position (see Figures 7-8) and is in the puncture position in the initial state before operation of the operating body 5 (see Figures 1, 4-5), a sensor unit holder 7 that integrally holds the sensor unit 2 in the initial state and can be raised from the pre-indentation position (see Figures 1, 4) to the post-indentation position (see Figures 5-8) relative to the housing 4, a spring 8 that generates a biasing force to raise the operating body 5 relative to the sensor unit holder 7, and an operation restricting part 9 that restricts the downward movement of the operating body 5 from the pre-operation position.

[0023] In this embodiment, the direction along the central axis O of the outer peripheral wall portion 4a of the housing 4 is called the vertical direction, the direction along the vertical direction from the biological surface 3 side toward the puncture device 1 side is called the upward direction, the opposite direction is called the downward direction, the direction perpendicular to the central axis O is called the radial direction, and the direction that circles the central axis O is called the circumferential direction.

[0024] As shown in Figure 4, in the initial state, after the puncture needle 6a and sensor 2a are inserted into the biological surface 3 and the attachment part 2b1 is attached to the biological surface 3, the sensor unit holder 7 is moved from the pre-press position to the post-press position as shown in Figure 5, when the housing 4, along with the operating body 5, is pushed down against the biasing force of the spring 8, thereby releasing the restriction of the operating restriction part 9. As shown in Figure 5, in the release state after the restriction of the operating restriction part 9 has been released, the operating body 5 is pushed down against the biasing force of the spring 8 to the post-operation position as shown in Figure 6, engaging with the needle holder 6 by elastic deformation, and when the pushing operation is released, it rises back up to the pre-operation position due to the biasing force of the spring 8 as shown in Figure 7, thereby raising the needle holder 6 to the removal position.

[0025] As shown in Figures 8-9, the puncture device 1 detaches from the biological surface 3, leaving the sensor unit 2 behind, with the needle holder 6 raised to the withdrawal position. In this embodiment, the puncture device 1 has a needle cover 10 that is slidably and detachably engaged with the sensor unit 2 in the vertical direction and surrounds the outer circumference of the puncture needle 6a, and a cap 11 that covers the needle cover 10 and the sensor unit 2 from below and is removed from the housing 4 when use begins, but is not limited to this.

[0026] The housing 4 has a cylindrical outer wall portion 4a centered on a central axis O, and a top wall portion 4b connected to the upper end of the outer wall portion 4a, forming a top-cylindrical shape. The operating body 5 has a button portion 5a that protrudes upward through a central opening 4b1 located in the center of the top wall portion 4b in the upper view in the initial state and is pressed.

[0027] The operation restricting unit 9 can be released by elastically deforming the restriction on the operating body 5, and the sensor unit holder 7 restricts the elastic deformation of the operation restricting unit 9 only when it is in the pre-press position, out of the pre-press position and post-press position.

[0028] More specifically, the operation restricting section 9 is composed of a restricting piece 4c extending downward from the top wall section 4b, and the restricting piece 4c can release the restriction of the operation restricting section 9 by elastically deforming radially outward, and the sensor unit holder 7 supports the restricting piece 4c from the radially outward only when it is in the pre-press position, of the pre-press position and post-press position.

[0029] The sensor unit holder 7 can be released from its hold on the sensor unit 2 by elastic deformation, and the needle holder 6 restricts the elastic deformation of the sensor unit holder 7 only when it is in the puncture position (of the two positions: puncture position and withdrawal position).

[0030] More specifically, the sensor unit holder 7 has a retaining piece 7a that can be released from the sensor unit 2 by elastically deforming radially outward, and the needle holder 6 supports the retaining piece 7a radially outward only when it is in the puncture position of the two positions (puncture position and withdrawal position).

[0031] The puncture device 1 has a withdrawal restriction unit 12 that restricts the upward movement of the needle holder 6 from the puncture position to the withdrawal position in its initial state, and the operating unit 5 releases the restriction of the withdrawal restriction unit 12 when pressed.

[0032] More specifically, the removal restriction section 12 is composed of a removal restriction piece 7b provided on the sensor unit holder 7. In its initial state, the removal restriction piece 7b engages with the needle holder 6, and when the operating body 5 is pressed, it elastically deforms the removal restriction piece 7b radially, thereby releasing the restriction of the removal restriction section 12.

[0033] The operating body 5 has an engaging piece 5b that elastically deforms and engages with the needle holder 6 when the operating body 5 is pressed in the release state and moves to the post-operation position. The engaging piece 5b is pressed against the needle holder 6 by descending relative to the needle holder 6, elastically deforms radially, and after overcoming the locking portion of the needle holder 6, it returns to its original shape to lock the locking portion. Multiple engaging pieces 5b are provided, offset from each other in the circumferential direction.

[0034] The operating body 5 has an operating body body 5c that receives the upper end of a spring 8 that expands and contracts vertically, the button extends upward from the operating body body 5c and the engaging piece 5b extends downward from the operating body body 5c. The operating body body 5c has a pressing part 5d that, when the operating body 5 is pressed, presses the removal restricting piece 7b radially and elastically deforms it, thereby releasing the restriction of the removal restricting part 12. When the sensor unit holder 7 is in the post-pressed position and the operating body 5 descends from the pre-operation position, the operating body body 5c presses the restricting piece 4c radially outward and elastically deforms it radially outward, thereby releasing the restriction on the operating body 5 by the operating restricting part 9.

[0035] As shown in Figures 1 and 2, the sensor unit holder 7 has a holder body 7c that receives the lower end of the spring 8. The holder body 7c has a contact surface 7c1 that contacts the upper surface of the sensor unit 2. The retaining piece 7a of the sensor unit holder 7 is provided at the lower end of the sensor unit holder body 7c and extends radially inward from the holder body 7c. The removal restricting piece 7b of the sensor unit holder 7 extends upward from the holder body 7c. The holder body 7c is held on the inner circumferential surface of the outer peripheral wall portion 4a of the housing 4 so as to be able to rise from the pre-press position to the post-press position while its rotation around the central axis O is restricted.

[0036] The sensor unit 2 has a sensor unit body 2b that is circular in top view and holds the sensor 2a, with an attachment portion 2b1 on its lower surface. The sensor unit body 2b has a locking recess 2b2 on its outer circumferential surface that opens radially outward and downward. The free end of the retaining piece 7a has a locking portion 7a1 that locks into the locking recess 2b2. The retaining body 7c has a support surface 7c2 that abuts against and supports the portion of the outer circumferential surface of the sensor unit body 2b opposite to the locking recess 2b2.

[0037] As shown in Figure 2, in this embodiment, three retaining pieces 7a, three locking recesses 2b2, and three support surfaces 7c2 are provided, offset from each other in the circumferential direction. The number of retaining pieces 7a, locking recesses 2b2, and support surfaces 7c2 provided on the puncture device 1 can be set as appropriate.

[0038] The housing 4 has a first elastic piece 4d that, in its initial state, restricts the sensor unit holder 7 from descending from its pre-press position by engaging with the sensor unit holder 7. The first elastic piece 4d extends downward from the top wall portion 4b of the housing 4. When the sensor unit holder 7 is assembled to the pre-press position during manufacturing, the first elastic piece 4d is pressed by the holder body 7c, which rises relative to the housing 4, and elastically deforms radially. After overcoming the locking portion of the holder body 7c, it returns to its original shape and locks the locking portion.

[0039] The housing 4 has a second elastic piece 4e that engages with the sensor unit holder 7 when the sensor unit holder 7 rises from the pre-press position to the post-press position, thereby restricting the sensor unit holder 7 from descending from the post-press position. The second elastic piece 4e extends downward from the top wall portion 4b of the housing 4. When the sensor unit holder 7 rises from the pre-press position to the post-press position, the second elastic piece 4e is pressed against the holder body 7c and elastically deforms radially, and after overcoming the locking portion of the holder body 7c, it returns to its original shape to lock the locking portion. At this time, a click sound is generated when the second elastic piece 4e overcomes the locking portion of the holder body 7c, and the user is given the sensation that the pressing operation of the housing 4 is complete.

[0040] The housing 4 has a third elastic piece 4f. The third elastic piece 4f restricts the needle holder 6 from descending from the withdrawal position by engaging with the needle holder 6 as the needle holder rises from the puncture position to the withdrawal position. The third elastic piece 4f extends downward from the top wall portion 4b of the housing 4. When the needle holder 6 rises from the puncture position to the withdrawal position, the third elastic piece 4f is pressed by the needle holder 6 and elastically deforms radially inward, then recovers its shape after overcoming the locking portion of the needle holder 6, thereby locking the locking portion.

[0041] As partially shown in Figure 3, three of each of the restricting piece 4c, first elastic piece 4d, second elastic piece 4e, and third elastic piece 4f are provided on the housing 4, offset in the circumferential direction. The number of restricting pieces 4c, first elastic piece 4d, second elastic piece 4e, and third elastic piece 4f provided on the housing 4 can be set as appropriate.

[0042] According to this embodiment, after the puncture needle 6a and sensor 2a are inserted subcutaneously via the biological surface 3 and the attachment portion 2b1 is attached to the biological surface 3, even if a pressing operation is mistakenly performed on the operating body 5 before the operation to press down the housing 4, the operating body 5 is prevented from descending from its pre-operation position by the operation restricting portion 9. Therefore, before the operating body 5 descends from its pre-operation position by the pressing operation, the housing 4 is reliably pressed down against the biasing force of the spring 8 along with the operating body 5, and the attachment portion 2b1 is further pressed against the biological surface 3 via the spring 8 and the sensor unit holder 7. Thus, the sensor unit 2 can be firmly attached to the biological surface 3. Furthermore, in this state, the sensor unit holder 7 is held in the post-pressed position by the second elastic piece 4e, making it easy to perform subsequent pressing operations on the operating body 5. Furthermore, until the puncture needle 6a is removed from the biological surface 3 by the pressing operation, the sensor unit 2 is held in the sensor unit holder 7 by the retaining piece 7a, thereby suppressing the occurrence of misalignment between the sensor unit 2 and the puncture needle 6a, etc.

[0043] While embodiments of this disclosure have been described above, this disclosure is not limited to the embodiments described above, and the embodiments described above can be modified in various ways without departing from the gist of this disclosure. [Explanation of symbols]

[0044] 1 Puncture device 2 Sensor Units 2a Sensor 2b Sensor unit body 2b1 Attachment area 2b2 Recessed 3. Biological surface 4 cabinets 4a Outer wall 4b Ceiling wall section 4b1 Central opening 4c regulation piece 4d First elastic piece 4e Second elastic piece 4f Third elastic piece 5 Operating Body 5a Button section 5b Engagement piece 5c Operating Unit 5d Pressing part 6 Needle holder 6a puncture needle 7 Sensor unit holder 7a Holding piece 7a1 Locking part 7b Removal of regulating piece 7c Holder body 7c1 Contact surface 7c2 Support surface 8 springs 9. Operation Regulator 10 Needle Cover 11 caps 12 Removal control section O center axis

Claims

1. The casing and An operating body that can move up and down relative to the housing between a pre-operation position and a post-operation position lower than the pre-operation position, A sensor unit having a sensor that extends in a long length downward and an attachment portion that is attached to a biological surface, The needle holder integrally holds the puncture needle having the downward-facing needle tip, and the puncture needle can be raised from the puncture position where it houses the sensor to the withdrawal position where it detaches from the sensor, and the needle holder is in the puncture position in the initial state before operation of the operating body, In the initial state, the sensor unit is held integrally, and the sensor unit holder is capable of rising from the pre-press position to the post-press position relative to the housing, A spring that generates a biasing force to raise the operating body relative to the sensor unit holder, It has an operation restricting unit that restricts the downward movement of the operating body from the pre-operation position, The sensor unit holder moves from the pre-press position to the post-press position when, after the initial state in which the puncture needle and the sensor are inserted into the biological surface and the adhesive portion is attached to the biological surface, the housing is pressed down against the biasing force of the spring along with the operating body, thereby releasing the restriction of the operating restriction portion. A puncture device wherein the operating body engages with the needle holder by elastic deformation when pressed against the biasing force of the spring in the release state where the restriction of the operating restraining part is released, and rises to the pre-operation position by the biasing force of the spring when the pressing operation is released, thereby raising the needle holder to the withdrawal position.

2. The aforementioned operation restricting unit can be released by elastically deforming the restriction on the operating body. The puncture device according to claim 1, wherein the sensor unit holder restricts the elastic deformation of the operation restricting portion only when it is in the pre-press position among the pre-press position and the post-press position.

3. The sensor unit holder can be released from its hold on the sensor unit by elastic deformation. The puncture device according to claim 1, wherein the needle holder restricts the elastic deformation of the sensor unit holder only when it is in the puncture position among the puncture position and the withdrawal position.

4. The housing has an outer periphery wall and a top wall connected to the outer periphery wall. The puncture device according to claim 1, wherein the operating body has a button portion that penetrates the top wall portion and protrudes upward in the initial state.

5. The aforementioned operating restriction section is composed of a restricting piece extending downward from the top wall section. The restricting piece can be released by elastically deforming the restriction of the operating restricting part radially outward. The puncture device according to claim 4, wherein the sensor unit holder supports the restricting piece from the radially outer side only when it is in the pre-indentation position among the pre-indentation position and the post-indentation position.

6. The sensor unit holder has a retaining piece that can be released from the sensor unit by elastically deforming radially outward, The puncture device according to claim 1, wherein the needle holder supports the retaining piece from the radially outer side only when it is in the puncture position among the puncture position and the withdrawal position.

7. In the initial state, it has a withdrawal restricting unit that restricts the upward movement of the needle holder from the puncture position to the withdrawal position, The puncture device according to claim 1, wherein the operating body releases the restriction of the withdrawal restriction unit when the pressing operation is performed.

8. The removal restriction section is composed of a removal restriction piece provided on the sensor unit holder, The removal restricting piece engages with the needle holder in the initial state, The puncture device according to claim 7, wherein the operating body releases the restriction of the withdrawal restriction portion by elastically deforming the withdrawal restriction piece radially when the pressing operation is performed.

9. The puncture device according to claim 1, wherein the housing restricts the sensor unit holder from descending from the pre-press position in the initial state by engaging with the sensor unit holder.

10. The puncture device according to claim 1, wherein the housing engages with the sensor unit holder when the sensor unit holder rises from the pre-press position to the post-press position, thereby restricting the sensor unit holder from descending from the post-press position.

11. The puncture device according to claim 1, wherein the housing restricts the needle holder from descending from the withdrawal position by engaging with the needle holder as the needle holder rises from the puncture position to the withdrawal position.

Images