Puncture device and medicinal solution administering device equipped with puncture device

Abstract

In a housing (14) of a puncture device (10), an abutment member (68) having an abutment surface (106) that comes into contact with the skin (S) of a patient is movably disposed. The abutment member (68) is provided so as to be capable of protruding from a contact surface (26) of the housing (14). A needle member (66) makes a relative movement with respect to the abutment member (68) so as to be capable of protruding toward the skin (S) from the abutment surface (106). When there is a change in relative position between the housing (14) and a portion (S1) of the skin (S) facing the abutment surface (106) in a state where the contact surface (26) of the housing (14) is in contact with the skin (S), the abutment member (68) moves relative to the housing (14) so as to maintain the contact between the abutment surface (106) and the skin (S).

Description

Lancing device and drug solution administration device equipped with lancing device

[0001] The present invention relates to a puncturing device having a needle member for puncturing the skin of a living body, and a drug solution administration device equipped with the puncturing device.

[0002] Japanese Patent Application Laid-Open Publication No. 2004-208726 discloses a puncturing device for puncturing the skin of a user (patient) who is to receive a drug with a puncture needle. The puncturing device has a main body, a puncturing part housed inside the main body, and a movable body that holds the puncturing part. The puncturing part has a needle at its tip and is held on the bottom surface of the movable body. The puncturing part is arranged so as to be movable together with the movable body toward the bottom wall of the main body.

[0003] After the bottom wall of the main body is brought into close contact with the user's skin, the puncturing section is moved toward the bottom wall together with the moving body, causing the needle to protrude from the bottom wall and puncture the skin.

[0004] When the skin is punctured by the needle, the user can move to separate the bottom wall of the main body from the skin, creating a space between the puncture device and the skin, making it easier for the needle to come out of the skin.

[0005] The present invention aims to solve the above-mentioned problems.

[0006] One aspect of the present invention is a puncture device comprising: a housing having a contact surface that contacts the skin of a living body; an abutment member having an abutment surface that contacts the skin and is movably mounted on the housing, with the abutment surface capable of protruding from the contact surface; and a needle member having a puncture needle and movable relative to the abutment member, with the puncture needle capable of protruding from the abutment surface toward the skin; wherein, when the relative position between the housing and the part of the skin facing the abutment surface changes while the housing is in contact with the skin, the abutment member moves relative to the housing so as to maintain contact between the abutment surface and the skin.

[0007] According to the present invention, when the skin of a living body is punctured by the puncture needle, even if the relative position between the housing and the skin changes due to the body movement of the living body, the abutment member moves relative to the housing to follow the skin, thereby effectively preventing the puncture needle from coming out of the skin.

[0008] FIG. 1 is a partially omitted perspective view of a drug solution administration device including a puncturing device according to an embodiment of the present invention. FIG. 2 is an enlarged plan view of the vicinity of the puncturing device in the drug solution administration device of FIG. 1. FIG. 3 is a cross-sectional view of the puncturing device shown in FIG. 2. FIG. 4 is an exploded perspective view of the puncturing device shown in FIG. 3. FIG. 5 is a cross-sectional view of the tip of the housing taken along line V-V in FIG. 2. FIG. 6 is a cross-sectional view taken along line VI-VI in FIG. 3. FIG. 7 is a partially cross-sectional perspective view of the puncturing device shown in FIG. 4. FIG. 8 is an overall front view of the puncturing device shown in FIG. 7. FIG. 9 is a cross-sectional view of the housing of the drug solution administration device shown in FIG. 3 in contact with the patient's skin. FIG. 10 is a partially cross-sectional perspective view of the puncturing mechanism during puncturing. FIG. 11 is a cross-sectional plan view of the abutting member of FIG. 10 as seen from above. FIG. 12 is a cross-sectional view showing the puncturing by the puncturing needle. FIG. 13 is a cross-sectional view showing the state in which the skin is separated from the housing during puncturing by the puncturing device shown in FIG. 12.

[0009] 1, a puncture device 10 according to this embodiment is used in a medicinal solution administration device 12 capable of administering a medicinal solution M. The medicinal solution administration device 12 is used, for example, to be brought into contact with a patient's skin S (see FIG. 9) and to administer the medicinal solution M subcutaneously to the patient.

[0010] As shown in FIG. 1, the drug solution administration device 12 includes a housing 14, a prefilled syringe 16 that stores drug solution M, a moving mechanism 18 that delivers the drug solution M from the prefilled syringe 16, and a puncture device 10 that can puncture the patient's skin S (see FIG. 9).

[0011] The housing 14 serves as a housing for both the medicinal solution administration device 12 and the lancing device 10. That is, the medicinal solution administration device 12 and the lancing device 10 share the housing 14.

[0012] The housing 14 includes a housing main body 20 and a housing cover 22. When administering a medicinal solution M using a medicinal solution administration device 12 including the lancing device 10, the housing main body 20 is placed on the patient's skin S, and the housing cover 22 is placed on the opposite side of the skin S with the housing main body 20 in between (see FIG. 9 ). The housing main body 20 and the housing cover 22 overlap in the thickness direction of the housing 14 (directions of arrows A1 and A2). The direction of arrow A1 indicates the direction toward the skin S when the medicinal solution administration device 12 is placed on the patient's skin S. The direction of arrow A2 indicates the direction away from the skin S when the medicinal solution administration device 12 is placed on the patient's skin S. For convenience of explanation, the direction from the housing cover 22 toward the housing main body 20 (direction of arrow A1) will be referred to as downward, and the direction from the housing main body 20 toward the housing cover 22 (direction of arrow A2) will be referred to as upward.

[0013] In a top view of the drug solution administration device 12, the housing 14 has a rectangular shape that is long in the longitudinal direction (the direction of arrow B). The housing cover 22 covers the upper part of the housing main body 20. The housing main body 20 and the housing cover 22 are separable in the vertical direction (the directions of arrows A1 and A2 in FIG. 1 ).

[0014] The housing 14 has a space 24 surrounded by a housing body 20 and a housing cover 22, and the space 24 of the housing 14 accommodates the pre-filled syringe 16, the moving mechanism 18, and the lancing device 10.

[0015] As shown in Fig. 3 , the bottom wall 20a of the housing main body 20 has a contact surface 26 that comes into contact with the patient's skin S. In this embodiment, the housing 14 has an adhesive patch 25 fixed to the bottom wall 20a of the housing main body 20, one side of the adhesive patch 25 serving as the contact surface 26. The contact surface 26 is flat along the longitudinal direction of the housing 14 (the direction of arrow B in Fig. 2 ) and the width direction (the direction of arrow C in Fig. 2 ) perpendicular to the longitudinal direction. The bottom wall 20a has a first hole 28. The first hole 28 is located at the tip of the housing main body 20 along the longitudinal direction. The first hole 28 penetrates the bottom wall 20a to communicate the outside of the housing main body 20 with the space 24.

[0016] The bottom wall 20a of the housing main body 20 has a stopper portion 30. The stopper portion 30 protrudes from the bottom wall 20a toward the housing cover 22 and is formed in an annular shape surrounding the first hole portion 28. In other words, the stopper portion 30 is disposed on the outer periphery of the first hole portion 28.

[0017] The top wall 22a of the housing cover 22 is formed parallel to the bottom wall 20a of the housing main body 20. The top wall 22a of the housing cover 22 has a second hole 32. The second hole 32 is located at the tip of the housing cover 22. The first hole 28 and the second hole 32 face each other in the thickness direction of the housing 14. The top wall 22a has an annular protrusion 34 that surrounds the second hole 32. The annular protrusion 34 protrudes upward (in the direction of arrow A2) from the top wall 22a. The annular protrusion 34 is located radially outward and spaced apart from the second hole 32.

[0018] An elastically deformable cover member 36 is disposed on the upper wall 22a of the housing cover 22. The cover member 36 is cap-shaped. The cover member 36 is disposed inside the annular protrusion 34. The cover member 36 has an outer edge portion 36a and a covering portion 36b disposed inside the outer edge portion 36a. The outer edge portion 36a abuts against the upper wall 22a of the housing cover 22 adjacent to the inner circumferential surface of the annular protrusion 34.

[0019] The covering portion 36b is offset in the axial direction (in the direction of arrow A2) from the outer edge portion 36a and faces the second hole portion 32. The covering portion 36b is disposed at a distance upward (in the direction of arrow A2) from the upper wall 22a of the housing cover 22. The covering portion 36b protrudes upward (in the direction of arrow A2) from the annular protrusion 34. The second hole portion 32 is covered by the cover member 36.

[0020] The upper wall 22a of the housing cover 22 has a support portion 38. The support portion 38 is cylindrical and protrudes from the upper wall 22a toward the housing main body 20, surrounding the second hole portion 32. The second hole portion 32 passes through from the upper wall 22a to the lower end of the support portion 38. The inner circumferential surface of the support portion 38 has a housing side receiving portion 40 that is recessed radially outward. The housing side receiving portion 40 is a step formed from the lower end of the support portion 38 toward the upper wall 22a of the housing cover 22.

[0021] As shown in FIG. 1 , the prefilled syringe 16 is housed inside the housing 14 and arranged along the longitudinal direction (direction of arrow B) of the housing 14. The prefilled syringe 16 has a barrel 42, a gasket 44, and a rod 46. The barrel 42 is cylindrical with an open base end and axially extending. The tip of the barrel 42 has a nozzle 48 protruding toward the tip. A gasket 44 is movably housed inside the barrel 42. The gasket 44 is made of an elastic material and is inserted liquid-tightly inside the barrel 42. A chamber 50 filled with a medicinal solution M is located between the tip of the barrel 42 and the gasket 44.

[0022] The rod 46 is formed in a cylindrical shape. The distal end of the rod 46 is inserted into the barrel 42 and connected to the proximal end of the gasket 44. The proximal end of the rod 46 is disposed outside the barrel 42. The rod 46 is disposed so as to be movable relative to the barrel 42 in the axial direction (distal direction, proximal direction, direction of arrow B).

[0023] The movement mechanism 18 includes a motor 52, a gear unit 54, and a shaft 56. The motor 52 is arranged in parallel with the pre-filled syringe 16. The motor 52 is electrically connected to a power supply unit 58. The power supply unit 58 is arranged toward the tip of the motor 52. The power supply unit 58 is capable of supplying power to the motor 52. Power is supplied from the power supply unit 58 to the motor 52, and a drive shaft (not shown) of the motor 52 is driven to rotate by the power. Drive control of the motor 52 is performed by a control unit (not shown).

[0024] The gear unit 54 is disposed toward the proximal end of the motor 52. The gear unit 54 has a drive gear 60 connected to the drive shaft, a driven gear 62 connected to the shaft 56, and an intermediate gear 64 meshed with the drive gear 60 and the driven gear 62. The intermediate gear 64 is disposed between the drive gear 60 and the driven gear 62. The drive gear 60, the driven gear 62, and the intermediate gear 64 are aligned in the width direction of the housing 14 (the direction of arrow C).

[0025] When the motor 52 is driven to rotate, the drive gear 60 rotates together with the drive shaft of the motor 52. As the drive gear 60 rotates, the intermediate gear 64 and the driven gear 62 rotate, causing the shaft 56 to rotate.

[0026] The shaft 56 extends along the axial direction and is inserted into the rod 46. Inside the rod 46, the outer peripheral surface of the shaft 56 and the inner peripheral surface of the rod 46 are threadedly engaged. The shaft 56 is housed together with the rod 46 in the barrel 42 of the pre-filled syringe 16. A driven gear 62 is connected to the base end of the shaft 56.

[0027] When the driving force of motor 52 is transmitted to shaft 56 via gear portion 54 and shaft 56 rotates, rod 46 threadedly engaged with shaft 56 moves axially (in the direction of arrow B). As rod 46 moves, gasket 44 moves axially together with rod 46 within barrel 42, and gasket 44 feeds medicinal solution M from chamber 50 toward the distal end.

[0028] The lancing device 10 is disposed at the distal end of the housing 14. As shown in Figure 3, the lancing device 10 faces the first and second apertures 28, 32.

[0029] The lancing device 10 includes a needle member 66, an abutment member 68, and a lancing mechanism 70 that urges the needle member 66 toward the skin S of the patient.

[0030] The needle member 66 includes a puncture needle 72 and a needle hub 74 that holds the puncture needle 72. The puncture needle 72 is a hollow needle. The tip of the puncture needle 72 is capable of puncturing the patient's skin S. The base end of the puncture needle 72 is held at the axial center of the needle hub 74.

[0031] The needle hub 74 has a hub body 76. When viewed in the axial direction of the needle hub 74, the hub body 76 is circular. The hub body 76 has a large diameter portion 80 and a small diameter portion 82. The large diameter portion 80 is disposed toward the tip of the hub body 76 (in the direction of arrow A1). The tip of the hub body 76 (large diameter portion 80) has a hub surface 84. The hub surface 84 is a flat surface that is perpendicular to the axis of the needle hub 74. The base end of the puncture needle 72 is held at the axial center of the hub surface 84. When the patient's skin S is punctured by the needle member 66, the hub surface 84 is the surface that comes into contact with the skin S (see FIG. 12 ).

[0032] The small diameter portion 82 is disposed in the proximal direction (the direction of arrow A2) of the large diameter portion 80. The diameter of the small diameter portion 82 is smaller than the diameter of the large diameter portion 80. At the boundary between the small diameter portion 82 and the large diameter portion 80, there is provided an annular hub-side receiving portion 86 that extends radially.

[0033] The large diameter portion 80 of the hub body 76 has a communication passage 88. The tip of the communication passage 88 extends along the axial center of the hub body 76 and opens into the hub surface 84. The tip of the communication passage 88 communicates with the interior of the puncture needle 72. The base end of the communication passage 88 extends radially outward and opens into the outer peripheral surface of the large diameter portion 80. The outer peripheral surface of the large diameter portion 80 has a connection hole 90 (see FIG. 4 ), and the connection hole 90 and the base end of the communication passage 88 communicate with each other.

[0034] As shown in Figure 5, the connection hole 90 of the needle hub 74 and the prefilled syringe 16 are connected by an elastically deformable tube 92. The tube 92 is a tubular body and is disposed at the tip of the housing 14 (see Figure 2). The tube 92 is flexible and can deliver the medicinal liquid M from the prefilled syringe 16 to the needle member 66. The medicinal liquid M is supplied from the prefilled syringe 16 through the tube 92 to the communication path 88 (see Figure 3) of the needle member 66, and is delivered from the communication path 88 to the puncture needle 72. The tube 92 has a spirally wound helical portion 94, a first extension portion 96 extending from one end of the helical portion 94, and a second extension portion 98 extending from the other end of the helical portion 94.

[0035] The spiral portion 94 has a substantially circular shape and is wound multiple times in the vertical direction (in the direction of arrows A1 and A2). As shown in FIG. 2, the first extension portion 96 extends substantially linearly along the width direction of the housing 14. An end of the first extension portion 96 is connected to the nozzle 48 of the prefilled syringe 16. The second extension portion 98 extends along the longitudinal direction of the housing 14. As shown in FIG. 5, an end of the second extension portion 98 is connected to the connection hole 90 of the needle hub 74. The spiral portion 94 of the tube 92 is accommodated inside the housing 14 in a bent vertical state. When the needle member 66 is displaced relative to the housing 14 in the axial direction of the needle member 66 (in the direction of arrows A1 and A2), the second extension portion 98 moves together with the needle member 66, thereby elastically deforming the spiral portion 94 of the tube 92.

[0036] As shown in Figure 4, the needle hub 74 further has a pair of guided portions 78 arranged radially outward from the hub body 76. The tips of the guided portions 78 are connected to the outer peripheral surface of the large diameter portion 80. The pair of guided portions 78 face the outer peripheral surface of the small diameter portion 82 and are arranged spaced radially outward from the outer peripheral surface of the small diameter portion 82. One guided portion 78 and the other guided portion 78 are arranged symmetrically with respect to the axial center of the hub body 76. Each guided portion 78 has a locking portion 100. The locking portion 100 is arranged at the tip of the guided portion 78. The locking portion 100 has a flat shape that is perpendicular to the axial direction of the needle hub 74.

[0037] As shown in FIG. 6, in a cross section perpendicular to the axial direction of the needle member 66, the cross section of the guided portion 78 is arc-shaped.

[0038] As shown in FIG. 3 , the abutment member 68 is movably provided in the housing 14 along the thickness direction of the housing 14 (in the direction of arrows A1 and A2). The abutment member 68 is disposed in the first hole 28 of the housing main body 20. As shown in FIG. 4 , the abutment member 68 includes a cylindrical portion 102 and a gate portion 104 protruding from the cylindrical portion 102 in the proximal direction (in the direction of arrow A2). The cylindrical portion 102 is disposed at the distal end of the abutment member 68. The distal end of the cylindrical portion 102 has an abutment surface 106 that can contact the patient's skin S (see FIG. 9 ). The abutment surface 106 is a flat surface that is perpendicular to the axis of the abutment member 68. As shown in FIG. 3 , the cylindrical portion 102 has an accommodation space 108 within which the needle member 66 is movably accommodated. The needle member 66 is movable axially (in the direction of arrows A1 and A2) relative to the abutment member 68 through the accommodation space 108.

[0039] The accommodation space 108 has an opening 110 that opens at the tip (contact surface 106) of the cylindrical portion 102. The puncture needle 72 can protrude from the contact surface 106 through the opening 110.

[0040] The base end of the cylindrical portion 102 has a flange portion 112 that expands radially outward. The flange portion 112 is annular and surrounds the accommodation space 108. As shown in Figure 4, the flange portion 112 has an annular spring bearing portion 114 that extends radially inward from the inner circumferential surface of the flange portion 112. The spring bearing portion 114 is disposed radially outward from the accommodation space 108.

[0041] The abutting member 68 has an engaging portion 115. The engaging portion 115 is a flat surface perpendicular to the axial direction of the abutting member 68. As shown in Figure 7, in the initial state of the lancing device 10, the locking portion 100 of the needle hub 74 abuts against the engaging portion 115 of the abutting member 68. This prevents the needle hub 74 from moving relative to the abutting member 68 in the puncture direction (toward the tip, in the direction of arrow A1).

[0042] As shown in FIG. 3 , a follower biasing member 116 is disposed inside the housing 14 between the cylindrical portion 102 of the abutment member 68 and the support portion 38 of the housing 14. The follower biasing member 116 is a spring member formed of a coil spring. The follower biasing member 116 is disposed between the housing side receiving portion 40 of the support portion 38 and the spring receiving portion 114 of the cylindrical portion 102. The small diameter portion 82 of the hub body 76 is inserted into one end of the follower biasing member 116. A convex portion 126 (described later) of the abutment member 68 is inserted into the other end of the follower biasing member 116. The biasing force of the follower biasing member 116 is applied against the abutment member 68. The biasing force of the follower biasing member 116 biases the abutment member 68 toward the distal end (the puncture direction, the direction of arrow A1). That is, the follower biasing member 116 biases the contact member 68 toward the skin S of the patient.

[0043] When the abutment surface 106 of the abutment member 68 is not in contact with the patient's skin S, the flange portion 112 of the abutment member 68 abuts against the stopper portion 30. The flange portion 112 of the abutment member 68 abuts against the stopper portion 30 of the housing 14, thereby preventing the abutment member 68 from coming off through the first hole portion 28.

[0044] The abutment member 68 has a protrusion 118 that protrudes from the contact surface 26 of the housing 14 when the abutment surface 106 of the abutment member 68 is not in contact with the skin S. The protrusion 118 protrudes to the outside of the housing 14 through the first hole 28 of the housing main body 20. When the contact surface 26 of the housing 14 comes into contact with the patient's skin S, the abutment surface 106 of the abutment member 68 is pressed by the skin S, causing the protrusion 118 to be accommodated inside the housing 14 through the first hole 28 (see FIG. 9 ).

[0045] As shown in Figure 4, the cylindrical portion 102 has a pair of guide grooves 120 that can guide the needle member 66 in the axial direction. The base ends of the guide grooves 120 are located adjacent to the engaging portion 115 in the circumferential direction of the cylindrical portion 102. The guide grooves 120 are recessed radially outward from the inner circumferential surface of the cylindrical portion 102 and face the accommodation space 108. The guided portion 78 of the needle member 66 can be inserted into the guide grooves 120. Each guide groove 120 extends along the axial direction of the abutting member 68 (in the direction of arrows A1 and A2).

[0046] The gate portion 104 extends in the proximal direction (direction of arrow A2) from the proximal end of the cylindrical portion 102. The gate portion 104 has a pair of pillar portions 122 and a bridge portion 124 connecting the proximal ends of the pillar portions 122. The pair of pillar portions 122 extend along the axial direction from the cylindrical portion 102 in the proximal direction and are arranged symmetrically with respect to the axial center of the cylindrical portion 102.

[0047] The bridge portion 124 is perpendicular to the axial direction of the abutment member 68 and connects the base end of one pillar portion 122 to the base end of the other pillar portion 122. The center of the bridge portion 124 has a convex portion 126 that protrudes toward the cylindrical portion 102. The bridge portion 124 and the needle member 66 face each other in the axial direction of the abutment member 68 (see FIG. 3).

[0048] The puncture mechanism 70, in response to operation by a user (e.g., a patient or a medical professional), protrudes the needle member 66 from the abutment surface 106 of the abutment member 68. As shown in Fig. 8 , the puncture mechanism 70 includes a pusher 128 provided with a pair of first inclined portions 132, a puncture biasing member 130 (described below), and a pair of second inclined portions 134 provided on the needle hub 74 and abutting against the first inclined portions 132.

[0049] As shown in Figure 3, the pusher 128 is arranged to be movable relative to the housing 14 in the puncture direction (axial direction, arrow A1 direction) of the puncture needle 72. The pusher 128 is arranged in the proximal direction of the abutment member 68 (arrow A2 direction). The pusher 128 has a cylindrical shape with a bottom. The gate portion 104 of the abutment member 68 is inserted into the pusher 128. The top of the pusher 128 has a pressing portion 136. In the initial state of the lancing device 10, the pressing portion 136 is arranged in the second hole portion 32 of the housing cover 22.

[0050] As shown in FIG. 7 , the outer peripheral surface of the pusher 128 has a pair of slit grooves 138 symmetrically arranged about the axial center of the pusher 128. The slit grooves 138 extend axially from the distal end to the proximal end of the pusher 128. The slit grooves 138 penetrate the pusher 128 radially. The pillar portions 122 of the abutting member 68 are inserted into the slit grooves 138. In the initial state of the lancing device 10, the proximal ends of the slit grooves 138 and the proximal ends of the pillar portions 122 of the abutting member 68 are spaced apart axially. By inserting the pillar portions 122 of the gate portion 104 into the pair of slit grooves 138, the pusher 128 and the abutting member 68 can move relative to each other only along the axial direction (the directions of arrows A1 and A2). In other words, the pusher 128 and the abutting member 68 are prevented from rotating relative to each other about the axes of the pusher 128 and the abutting member 68.

[0051] The puncture biasing member 130 is a spring member made of a coil spring. The puncture biasing member 130 is disposed between the bridge portion 124 (see FIG. 3 ) of the abutment member 68 and the hub-side receiving portion 86 of the needle hub 74. The biasing force of the puncture biasing member 130 is applied to the needle hub 74. The puncture biasing member 130 biases the needle member 66 toward the patient's skin S. The puncture biasing member 130 biases the needle member 66 toward the patient's skin S, thereby allowing the needle member 66 to move relative to the abutment member 68 in the puncture direction (direction of arrow A1).

[0052] 8 , the pair of first inclined portions 132 are disposed at the tip of the pusher 128. The first inclined portions 132 are inclined with respect to the axial direction of the pusher 128. In other words, the first inclined portions 132 are inclined with respect to the puncture direction (arrow A1 direction) of the puncture needle 72. The first inclined portions 132 are inclined toward the tip (arrow A1 direction) so as to extend clockwise when the pusher 128 is viewed from the base end toward the tip.

[0053] The second inclined portion 134 is disposed on each guided portion 78 of the needle hub 74. The second inclined portion 134 is disposed at the proximal end of the guided portion 78. The first inclined portion 132 of the pusher 128 can abut against the second inclined portion 134. The second inclined portion 134 is inclined with respect to the puncture direction (arrow A1 direction) of the needle member 66. In other words, the second inclined portion 134 is inclined toward the distal end (arrow A1 direction) so as to extend clockwise when the needle member 66 is viewed from the proximal end toward the distal end.

[0054] The second inclined portion 134 is inclined in the same direction as the first inclined portion 132. Therefore, in the initial state of the lancing device 10 shown in Fig. 7, the first inclined portion 132 and the second inclined portion 134 are in surface contact with each other.

[0055] Next, the operation of the medicinal solution administration device 12 including the lancing device 10 will be described.

[0056] First, in the medical solution administration device 12 before use (initial state) shown in FIG. 3, the tip (protrusion 118) of the abutting member 68 including the abutting surface 106 protrudes from the contact surface 26 (patch 25) of the housing 14.

[0057] 9 , by bringing the contact surface 26 of the housing 14 into contact with the patient's skin S (by attaching the patch 25 to the skin S), the contact surface 106 of the abutting member 68 comes into contact with the skin S, and the skin S presses the protruding portion 118 toward the housing 14 (in the direction of arrow A2). The abutting member 68 moves axially toward the housing 14 while compressing the following biasing member 116, and the protruding portion 118 is accommodated in the space 24 of the housing 14 through the first hole portion 28.

[0058] At this time, the needle member 66 and the pusher 128 move together with the abutment member 68 relative to the housing 14. The urging force of the puncture urging member 130 does not change the relative position of the abutment member 68 and the needle member 66. The relative position of the abutment member 68 and the pusher 128 also does not change.

[0059] As the needle member 66 moves, the spiral portion 94 of the tube 92 elastically deforms so as to contract upward in the axial direction.

[0060] As the abutment member 68 moves, the pusher 128 is pushed up by the needle member 66, and the pressing portion 136 of the pusher 128 is housed inside the cover member 36 through the second hole 32. Because the pressing portion 136 protrudes upward (in the direction of arrow A2) from the upper wall 22a of the housing cover 22, the user can press the pressing portion 136 in the puncture direction (in the direction of arrow A1) via the covering portion 36b of the cover member 36.

[0061] Next, the user presses pressing portion 136 of pusher 128 via cover member 36, pushing pressing portion 136 into housing 14. This causes pusher 128 to move in the puncture direction (direction of arrow A1) along support portion 38, and first inclined portion 132 presses second inclined portion 134 in the puncture direction. At this time, as shown in Figure 7, guided portion 78 having second inclined portion 134 is prevented from moving downward because locking portion 100 abuts engagement portion 115. The rotational position of needle member 66 relative to abutting member 68 in the initial state shown in Figure 7 is referred to as the "first position."

[0062] Therefore, when the first inclined portion 132 of the pusher 128 pushes the second inclined portion 134 of the needle hub 74 in the puncture direction (the direction of arrow A1), the pair of guided portions 78 receive a counterclockwise force due to the inclination of the first inclined portion 132 and the second inclined portion 134. As a result, the needle hub 74 begins to rotate counterclockwise from the first position around the axis of the needle hub 74 without moving in the puncture direction.

[0063] 10 and 11 , when the needle hub 74 rotates and the pair of guided portions 78 reach a second position where they face the base ends of the guide grooves 120, and the locking portion 100 disengages from the engaging portion 115, the needle hub 74 moves in the puncture direction (arrow A1 direction) due to the biasing force of the puncture biasing member 130. At this time, the guided portions 78 are inserted into the guide grooves 120, and the guided portions 78 are guided in the puncture direction along the guide grooves 120, moving the needle hub 74. The base end of the slit groove 138 of the pusher 128 abuts against the base end of the pillar portion 122 of the abutment member 68, and the pusher 128 is held in the puncture direction by the abutment member 68 (see FIG. 10 ).

[0064] 12, the needle hub 74 moves in the puncture direction (direction of arrow A1) relative to the abutment member 68, and the hub surface 84 abuts against the skin S, causing the puncture needle 72 to puncture the patient's skin S. At this time, as the needle member 66 moves in the puncture direction, the tube 92 elastically deforms downward.

[0065] After the puncture needle 72 has punctured the skin S, the power supply (not shown) of the medicinal solution administration device 12 is turned on, which supplies power to the motor 52 from the power supply unit 58 shown in FIG. 1 and drives the motor 52. As the motor 52 is driven, the drive gear 60, intermediate gear 64, and driven gear 62 each rotate, and the shaft 56 rotates, causing the rod 46 to move distally within the barrel 42. When the gasket 44 is pushed distally by the rod 46, the medicinal solution M in the chamber 50 is delivered from the nozzle 48 to the tube 92. The medicinal solution M is supplied to the communication passage 88 of the needle hub 74 shown in FIG. 12 and administered subcutaneously to the patient through the puncture needle 72.

[0066] Figure 13 shows a situation in which the contact surface 26 of the housing 14 is in contact with the patient's skin S and the skin S is punctured by the puncture needle 72, and due to the patient's body movement, etc., the opposing portion S1 of the skin S that faces the abutment member 68 and the needle member 66 and the contact surface 26 of the housing 14 move apart in the puncture direction of the needle member 66 (in the direction of arrow A1).

[0067] When the facing portion S1 of the skin S moves away from the contact surface 26 of the housing 14 in the puncture direction, the abutment member 68, biased by the biasing force of the following biasing member 116, moves relative to the housing 14 so as to maintain contact of the abutment surface 106 with the facing portion S1. This prevents the abutment surface 106 and the facing portion S1 from moving away from each other in the puncture direction. As the abutment member 68 moves in accordance with the facing portion S1, the needle member 66 moves together with the abutment member 68, maintaining the puncture of the skin S (facing portion S1) by the puncture needle 72.

[0068] As described above, in the embodiment of the present invention, the abutment member 68 having the abutment surface 106 that contacts the patient's skin S is movably provided on the housing 14, and the needle member 66 having the puncture needle 72 is movably provided on the abutment member 68. Therefore, even if the relative position of the opposing portion S1 of the skin S that faces the abutment surface 106 and the contact surface 26 of the housing 14 changes due to the patient's body movement or the like while the contact surface 26 of the housing 14 is in contact with the skin S, the abutment member 68 moves relative to the housing 14 to follow the opposing portion S1 of the skin S, thereby preventing the puncture needle 72 of the needle member 66 from coming out of the skin S.

[0069] The housing 14 is provided with a follow-up biasing member 116 capable of biasing the abutment member 68 toward the patient's skin S. The follow-up biasing member 116 maintains the abutment state of the abutment surface 106 of the abutment member 68 against the skin S (opposing portion S1), thereby reliably preventing the needle member 66 (puncture needle 72) from coming off.

[0070] In an initial state where the abutment surface 106 of the abutment member 68 is not in contact with the patient's skin S, the protrusion 118 of the abutment member 68 protrudes from the contact surface 26 of the housing 14, so that the abutment surface 106 of the abutment member 68 protruding from the contact surface 26 can be reliably brought into contact with the skin S. When the contact surface 26 of the housing 14 comes into contact with the skin S, the abutment member 68 is pressed by the skin S, causing the protrusion 118 to be accommodated within the space 24 of the housing 14, so that the contact surface 26 of the housing 14 can be brought into good contact with the skin S.

[0071] By providing a puncture biasing member 130 inside the housing 14 that can bias the needle member 66 toward the patient's skin S, the puncture biasing member 130 can cause the puncture needle 72 of the needle member 66 to protrude from the abutment surface 106 of the abutment member 68, thereby ensuring that the skin S is punctured.

[0072] A tube 92 for delivering the medicinal solution M to the needle member 66 and the puncture needle 72 is connected to the needle hub 74 of the needle member 66, and the tube 92 is flexible and accommodated in a bent state within the space 24 of the housing 14. As a result, when the needle member 66 moves axially relative to the housing 14, the tube 92 elastically deforms, allowing the tube 92 to suitably follow the needle member 66.

[0073] The above embodiment can be summarized as follows.

[0074] The puncture device of the above embodiment comprises a housing (14) having a contact surface (26) that contacts the skin (S) of a living body; an abutment member (68) having an abutment surface (106) that contacts the skin and is movably mounted on the housing, from which the abutment surface can protrude; and a needle member (66) having a puncture needle (72), which is movable relative to the abutment member and from which the puncture needle can protrude from the abutment surface toward the skin, and when the relative position between the housing and a portion (S1) of the skin facing the abutment surface changes while the housing is in contact with the skin, the abutment member moves relative to the housing so as to maintain contact between the abutment surface and the skin.

[0075] The lancing device includes a compliant biasing member (116) disposed within the housing and biasing the abutment member toward the skin.

[0076] The abutment member has a protrusion (118) that protrudes from the contact surface of the housing when the abutment surface of the abutment member is not in contact with the skin, and when the contact surface of the housing comes into contact with the skin, the abutment member is pressed against the skin, causing the protrusion to be accommodated inside the housing.

[0077] The lancing device includes a lancing biasing member (130) provided inside the housing and biasing the needle member toward the skin.

[0078] The puncture device comprises a puncture mechanism (70) that protrudes the needle member toward the skin against the abutment surface of the abutment member, and the puncture mechanism comprises: a pusher (128) that has a first inclined portion (132) inclined with respect to the puncture direction of the puncture needle and is movable in the puncture direction relative to the housing; the puncture biasing member; and a second inclined portion (134) that is provided on the needle member and inclined with respect to the puncture direction, with which the first inclined portion abuts; when the pusher moves in the puncture direction, the needle member rotates from a first position to a second position via the first inclined portion and the second inclined portion, around an axis along the puncture direction; and when the needle member reaches the second position, it moves in the puncture direction due to the biasing force of the puncture biasing member.

[0079] The needle member includes a needle hub (74) that holds the puncture needle, and the puncture biasing member is disposed between the abutment member and the needle hub.

[0080] The device is provided with a flexible tube (92) connected to the needle member for delivering a medicinal solution (M) to the needle member, the tube being accommodated in the housing in a bent state, and the tube being deformed in accordance with the displacement of the needle member relative to the housing.

[0081] The drug solution administration device includes a puncture device, and a pre-filled syringe (16) filled with a drug solution, connected to the needle member of the puncture device, and configured to deliver the drug solution to the puncture needle.

[0082] The present invention is not limited to the above disclosure, and various configurations can be adopted without departing from the gist of the present invention.

Claims

1. a housing having a contact surface that contacts the skin of a living body; a contact member having a contact surface that contacts the skin, the contact member being movably provided on the housing, the contact surface being protruding from the contact surface; a needle member having a puncture needle, the needle member being movable relative to the contact member, the puncture needle being capable of protruding from the contact surface toward the skin; Equipped with A puncture device in which, when the relative position between the housing and the part of the skin facing the abutment surface changes while the housing is in contact with the skin, the abutment member moves relative to the housing so as to maintain contact between the abutment surface and the skin.

2. The puncture device according to claim 1, The lancing device further comprises a follower biasing member disposed inside the housing and biasing the contact member toward the skin.

3. The puncture device according to claim 1 or 2, A puncture device in which the abutment member has a protrusion that protrudes from the contact surface of the housing when the abutment surface of the abutment member is not in contact with the skin, the protrusion has the abutment surface, and when the contact surface of the housing contacts the skin, the abutment member is pressed against the skin, causing the protrusion to be contained inside the housing.

4. The puncture device according to claim 1 or 2, A lancing device comprising a pricking biasing member provided inside the housing and biasing the needle member toward the skin.

5. The puncture device according to claim 4, a puncture mechanism for projecting the needle member toward the skin from the contact surface of the contact member, the puncture mechanism includes a pusher having a first inclined portion inclined with respect to a puncture direction of the puncture needle and movable in the puncture direction relative to the housing; The puncture biasing member, a second inclined portion provided on the needle member and inclined with respect to the puncture direction and against which the first inclined portion abuts; Equipped with When the pusher moves in the puncture direction, the needle member rotates from a first position to a second position via the first inclined portion and the second inclined portion about an axis along the puncture direction, A puncture device, wherein when the needle member reaches the second position, the needle member moves in the puncture direction by the biasing force of the puncture biasing member.

6. The puncture device according to claim 4, The needle member includes a needle hub that holds the puncture needle, The puncture device, wherein the puncture biasing member is disposed between the abutment member and the needle hub.

7. The puncture device according to claim 1 or 2, a flexible tube connected to the needle member for delivering a medicinal solution to the needle member; The tube is accommodated in the housing in a bent state, A puncture device, wherein the tube deforms with displacement of the needle member relative to the housing.

8. The puncture device according to claim 1 or 2, a pre-filled syringe filled with a medicinal solution, connected to the needle member of the puncture device, and configured to deliver the medicinal solution to the puncture needle; A drug solution administration device comprising: