WO2021088544A1 - 助针器以及包括助针器的医疗系统 - Google Patents

助针器以及包括助针器的医疗系统 Download PDF

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Publication number
WO2021088544A1
WO2021088544A1 PCT/CN2020/116839 CN2020116839W WO2021088544A1 WO 2021088544 A1 WO2021088544 A1 WO 2021088544A1 CN 2020116839 W CN2020116839 W CN 2020116839W WO 2021088544 A1 WO2021088544 A1 WO 2021088544A1
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WO
WIPO (PCT)
Prior art keywords
needle
sensor
firing
assembly
clamping
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Application number
PCT/CN2020/116839
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English (en)
French (fr)
Inventor
宋哲
道尔•马克
于非
郑攀
Original Assignee
微泰医疗器械(杭州)有限公司
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Application filed by 微泰医疗器械(杭州)有限公司 filed Critical 微泰医疗器械(杭州)有限公司
Publication of WO2021088544A1 publication Critical patent/WO2021088544A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031—Implanted circuitry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part

Definitions

  • the present application relates to the technical field of blood glucose monitoring, and more specifically to a needle aid for percutaneous implantation of a sensor and a medical system including the needle aid.
  • the existing blood glucose detection device can usually be attached to the skin of the patient, and the sensor of the blood glucose detection device is percutaneously implanted under the skin to continuously (for example, 14 days) monitor the blood glucose level in the patient's blood.
  • This small blood glucose detection device is usually equipped with a transmitter to transmit data about the blood glucose level monitored by the sensor to the receiver. The patient can read and process the data on the receiver, so as to know the blood glucose level in the body in real time.
  • Needle aids generally have implanted needles.
  • the implantation operation of the implantation needle can implant the implantation needle together with the sensor under the skin; and the withdrawal operation of the implantation needle can quickly withdraw the implantation needle from the skin of the human body.
  • the sensor is left under the skin. Therefore, it is necessary to provide a needle aid to quickly and stably realize the implantation and withdrawal operations of the implanted needle.
  • the blood glucose detection device is usually a disposable medical appliance, and some components of the blood glucose detection device including the sensor and the transmitter need to be discarded after the end of each use cycle. Therefore, how to reuse the components of the blood glucose detection device to reduce the use cost is also a problem that needs to be solved.
  • the needle aid includes: a cover; a contact housing, the contact housing is at least partially sleeved inside the cover, wherein the contact housing has a contact at its distal end for contacting the skin of a patient Needle entry assembly, the needle entry assembly is accommodated inside the contact housing and used to carry the sensor assembly including the sensor, the needle entry assembly can be moved from a position away from the contact surface to close to the The contact surface is positioned to implant the sensor percutaneously under the skin of the patient.
  • the needle insertion assembly includes: a needle holder, the needle holder is used to hold an implant needle; an implant member, the implant member includes a sensor located at its distal end for releasably receiving the sensor assembly A seat, and a needle holder seat on the proximal side thereof for releasably receiving the needle holder; and a clamping member that is coupled to the implant member and releasably clamps Holding the needle holder seat; wherein the clamping member can move from a clamping position to a release position relative to the implant member and the needle holder; in the clamping position, the clamping member Clamping force is applied to the needle holder seat to accommodate the needle holder in the needle holder seat, and in the release position, the clamping member no longer applies clamping to the needle holder seat Force, so that the needle holder seat releases the needle holder, so that the needle holder can move in the proximal direction.
  • the needle aid also includes a firing assembly, the firing assembly is used to maintain the needle insertion assembly in a position away from the contact surface, and in response to the firing trigger action to move the needle insertion assembly away from the contact surface The position moves to a position close to the contact surface.
  • the firing assembly includes: a firing member for receiving a firing triggering action, and moving from a holding position to a firing position in response to the firing triggering action; wherein, in the holding position, the firing member moves the The needle advancement assembly is maintained at a position away from the contact surface, and in the firing position, the firing member allows the needle advancement assembly to move to a position close to the contact surface; and a drive spring responds to the firing The member is in the holding position, the drive spring is held in a compressed state by the firing member and the clamping member, and in response to the firing member being in the firing position, the drive spring drives the needle insertion assembly Move to a position close to the contact surface.
  • the present application also provides a medical system.
  • the medical system includes: the aforementioned needle aid; the sensor assembly including the sensor and a battery compartment for installing a battery; and is independent of the needle aid and the Transmitter of the sensor assembly.
  • the sensor assembly is detachably connected to the needle insertion assembly of the needle aid, and when the needle insertion assembly and the sensor assembly move to a position close to the contact surface, the sensor is implanted percutaneously And the sensor assembly is detached from the needle insertion assembly and is retained on the patient's skin.
  • the transmitter engages the sensor assembly and is electrically coupled to the sensor and the battery to transfer the battery to the
  • the electrical component supplies power and receives and processes the detection result of the sensor by the electrical component; and the transmitter sends the detection result to the outside.
  • the present application also provides a medical system including: a sensor component and a transmitter with electrical components.
  • the sensor assembly includes a sensor for transcutaneously detecting blood glucose levels and a battery compartment for installing batteries.
  • the transmitter is detachably coupled to the sensor assembly, and when the sensor assembly is installed on the patient's skin, the transmitter can engage the sensor assembly and be electrically coupled to the sensor and the battery , In order to supply power to the electrical component by the battery and receive and process the detection result of the sensor by the electrical component. The transmitter sends the detection result to the outside.
  • Figures 1a and 1b respectively show a schematic diagram and a cross-sectional view of a needle aid according to an embodiment of the present application
  • Fig. 2 shows an exploded view of the needle aid in Figs. 1a and 1b, which shows various components inside the needle aid;
  • 3a and 3b show a schematic diagram and a cross-sectional view of a contact housing according to an embodiment of the present application
  • Figure 4 shows a cross-sectional view of the needle aid in the initial state after the cover is removed
  • Figure 5 shows the needle aid, in which the contact housing and the cover are in an unlocked position with each other, and the user's firing operation causes the firing member to move to the firing position;
  • 6a and 6b show cross-sectional views of different cross-sections of a needle insertion assembly according to an embodiment of the present application
  • FIGS 7a and 7b show an implant component according to an embodiment of the present application
  • FIGS. 8a and 8b show a clamping member according to an embodiment of the present application
  • Figure 9 shows a schematic diagram after the clamping member and the implant member are clamped to each other
  • Figure 10 shows the needle aid, in which the needle insertion assembly moves to the distal end under the action of the drive spring
  • Figure 11 shows the needle aid, in which the clamping member moves to a release position relative to the implant member due to inertia
  • Fig. 12 shows a sensor assembly according to an embodiment of the present application
  • Figure 13a shows the internal structure of the sensor assembly
  • Figure 13b shows the structure and connection relationship of the sensor, the conductive double-sided adhesive, the sensor base plate and the flexible circuit board;
  • Figure 14 shows the internal structure of the sensor assembly
  • Fig. 15 shows a schematic diagram of a transmitter according to an embodiment of the present application.
  • Fig. 16 shows a schematic diagram of a receiver according to an embodiment of the present application.
  • Figures 1a and 1b respectively show a schematic diagram of the external structure and a schematic cross-sectional view of the needle aid 100 according to an embodiment of the present application.
  • the internal structure and relative positions of the components of the needle aid 100 may be different depending on the specific use stage.
  • Figure 1b is a schematic cross-sectional view of the needle aid 100 in the initial state, and the internal structure of the needle aid 100 in other states during operation Will be described in other drawings.
  • the needle aid 100 shown in FIGS. 1a and 1b may be used for a sensor of a percutaneously implanted blood glucose detection device, and it may be configured to be located on the sensor assembly 500 shown in FIG. 10, for example.
  • the needle aid 100 includes a cover body 102 and a cover body 104 that are connected to each other, which are connected to each other by, for example, a screw thread or a snap connection.
  • a closed space is defined, in which various parts of the needle aid and a sensor (not shown in the figure) can be accommodated. Since the sensor needs to be percutaneously implanted under the skin, the internal closed space of the needle aid 100 provides a clean space to isolate external bacteria and other pollution sources, which facilitates the packaging and storage of the sensor.
  • Fig. 2 shows an exploded view of the needle aid 100 in Figs. 1a and 1b, which shows various components inside the needle aid 100. As shown in Figs. Hereinafter, the structure and function of each component inside the needle aid 100 will be described in detail with reference to FIG. 1b, FIG. 2 and other drawings.
  • the needle aid 100 includes a contact housing 106 sheathed inside the cover 102.
  • 3a and 3b show a perspective view and a cross-sectional view of the contact housing 106 according to an embodiment of the present application.
  • the contact housing 106 includes a barrel-shaped housing part 201 and ribs 202 circumferentially distributed around the housing part 201.
  • the rib 202 and the groove (not shown) on the inner surface of the cover 102 cooperate with each other to limit the edge between the contact housing 106 and the cover 102. Circumferential rotation, especially during sensor implantation.
  • the contact housing 106 further includes protrusions 204 distributed circumferentially around the housing part 201 and spaced apart from the rib 202.
  • the protrusion 204 is embedded in the elongated opening 205 with a predetermined axial length in the cover 102 to prevent the contact housing 106 from being separated from the cover 102.
  • the opening 205 has a longer axial length than the projection 204, thereby allowing the projection 204 to slide axially therein. In this way, the contact housing 106 and the cover body 102 can move relative to each other by a predetermined distance at most in the axial direction without excessive movement until they are separated from each other. It should be noted that FIG.
  • the contact housing 106 has two ribs 202 and two protrusions 204.
  • ribs and bumps may also be provided on the inner surface of the cover body 102, and corresponding grooves and openings may be provided on the contact housing 106.
  • other structures can also be used between the contact housing and the cover to avoid rotation in the circumferential direction and/or excessive sliding in the axial direction. For example, the circumferential rotation can be avoided by arranging the cover body and the contact housing to have a substantially matching oval shape.
  • the contact housing 106 includes a contact surface 206 at its distal end for contacting the skin of the patient. It can be understood that after removing the cover 104 from the needle aid 100, the user (for example, a patient) can move the needle aid 100 and abut the contact surface 206 against the skin surface of the patient, and then perform subsequent operations.
  • the proximal and proximal sides in this application refer to the end of the needle aid or its various components that are relatively close to the user when it is normally operated (implanted sensor operation), while the distal and distal sides refer to the needle aid The end of the device or its various parts is relatively far away from the user.
  • the needle aid 100 further includes a locking spring 108 compressed between the contact housing 106 and the cover 102.
  • One end of the locking spring 108 is installed in the locking spring seat 208 (FIGS. 3 a and 3 b) of the contact housing 106, and the other end abuts against the inner surface of the proximal end of the cover 102.
  • the inner surface of the proximal end of the cover 102 may also have a spring seat coupled to the locking spring 108.
  • the lock spring 108 may be configured to be able to compress or extend only in the axial direction, and provide the contact housing 106 and other coupled components with a driving force for axial movement when it is extended in the axial direction.
  • FIG. 4 shows a schematic cross-sectional view of the needle aid 100 in the initial state after the cover 104 is removed.
  • the needle aid 100 is locked and cannot perform the implantation of the sensor.
  • the locking spring 108 in the initial state, the locking spring 108 is in a compressed state, and the elastic biasing force provided by the locking spring 108 keeps the protrusion 204 contacting the housing 106 at the most distal position in the opening 205 of the cover 102, but The implant needle is also held inside the shield 102. At this time, the contact housing 106 and the cover 102 are in a locked position with each other.
  • an external driving force see FIG.
  • the contact housing 106 can move in the axial direction to further approach the cover 102, which allows the protrusion 204 to slide in the opening 205 until it is in the opening. The closest position within 205. At this time, the contact housing 106 and the cover 102 are in an unlocked position with each other (as described below with reference to FIG. 5).
  • the needle aid 100 further includes a firing member 110, the firing member 110 extends through the radial through hole 210 of the contact housing 106 (FIGS. 3a and 3b), and the first end of the firing member 110 through the cover 102
  • the opening 120 (the opening 120 is generally aligned with the radial through hole 210) extends out of the cover 102 to facilitate the user to perform a firing operation on the firing member 110.
  • the firing member 110 is provided with a groove 121 at the first end.
  • the groove 121 is The opening 120 is clamped on the clamping portion 122 of the cover 102, so that the firing member 110 is restricted to the holding position to prevent the user from performing a firing operation.
  • the clamping portion 122 moves relatively away from the groove 121 until it no longer clamps the groove. 121, which enables the user to move the firing member 110 to the firing position through a firing operation (as described below with reference to FIG. 5).
  • the mutual cooperation of the firing member 110 and the cover 102 makes the needle aid 100 operably in the unlocked position and the locked position.
  • the setting of the locked position can prevent the needle aid 100 from being inappropriate due to the user's misoperation. Ground firing, thereby reducing use failures and risks.
  • the design can also be simplified without using the above-mentioned locking mechanism.
  • the needle aid 100 can be initially in the unlocked position shown in FIG. 5, but the firing member 110 is in the non-fired position. That is, the user is not pressed inward to the firing position.
  • Fig. 5 shows a schematic diagram of the needle aid 100 in another state different from Figs. 1b and 4, in which the contact housing 106 and the cover 102 are in an unlocked position with each other, and the firing operation of the firing member 110 is pressed by the user The firing member 110 is moved to the firing position.
  • the needle aid 100 further includes a firing spring 112, one end of the firing spring 112 is mounted to the firing spring seat 212 (FIG. 3) of the contact housing 106, and the other end is connected to the first end of the firing member 110.
  • the firing spring 112 is compressed between the contact housing 106 and the firing member 110.
  • the firing spring 112 provides a restoring force to force the firing member 110 to return from the firing position to the holding position. That is, it moves in a direction opposite to the direction 2 shown in FIG. 5.
  • the needle aid 100 may be a single-use device, that is, after the firing member 110 is moved to the firing position, it does not need to move outward to return to the non-fired position; accordingly, the firing spring may not be provided.
  • the needle aid 100 further includes a needle insertion assembly installed inside the contact housing 106.
  • FIG. 6a shows a cross-sectional view of the needle insertion assembly 200 taken along the angle of FIG. 4
  • FIG. 6b shows a cross-sectional view of the needle insertion assembly 200 after being rotated 90 degrees in the axial direction from FIG. 4.
  • the needle insertion assembly includes an implant needle 111, a needle holder 113, a clamping member 114, an implant member 115, an inertial spring 116, and a release spring 117.
  • the needle holder 113 is configured to hold the implantation needle so that the implantation needle can move with the movement of the needle holder 113.
  • the release spring 117 is accommodated in the internal cavity of the needle holder 113, and its two ends are respectively coupled to the needle holder 113 and the implant member 115, so that the needle holder 113 is releasably coupled to the implant member 115 on. Before being released, the release spring 117 is compressed by the needle holder 113 and the implant member 115.
  • the implant member 115 includes a needle holder seat 302 for releasably receiving the needle holder 113 on its proximal side.
  • the needle holder seat 302 may include three elastic pawls 302 a-302 c, and the three elastic pawls 302 a-302 c enclose a cavity for accommodating the needle holder 113.
  • a radially inward force is applied to the outermost ends of the elastic pawls 302a-302c, for example, from the elastic ratchets.
  • the inward force of the corresponding position of the clamping member 114 (which will be described in detail below) on the periphery of the pawls 302a-302c can make the needle holder 113 be held by the elastic pawls 302a-302c against the elastic biasing force of the release spring 117 Inside the needle holder seat 302.
  • the implant member 115 also includes a sensor socket 304 for releasably receiving the sensor assembly 500 on its distal side.
  • the sensor assembly 500 can be generally stably mounted on the sensor base 304 and adhered to the skin after contact with the skin.
  • the adhesion force is sufficient to overcome the clamping between the sensor assembly 500 and the sensor base 304. Force/friction to allow the sensor assembly 500 to disengage from the sensor base 304.
  • the structure and working principle of the sensor base 304 of the implant member 115 will be described in detail below in conjunction with the clamping member 114.
  • Figures 8a-8b show a clamping member 114 according to an embodiment of the present application.
  • the clamping member 114 includes an annular housing inner surface 410, and a boss 412 located at the distal end of the annular inner surface 410 and extending radially inwardly along the annular housing inner surface 410.
  • the boss 412 exemplarily shown in FIGS. 8a and 8b only extends a part of the circumference on the inner surface 410 of the annular housing. In other embodiments, the boss 412 may extend more or less circumferentially on the inner surface 410 of the annular housing.
  • FIGS. 8a-8b show a clamping member 114 according to an embodiment of the present application.
  • the clamping member 114 includes an annular housing inner surface 410, and a boss 412 located at the distal end of the annular inner surface 410 and extending radially inwardly along the annular housing inner surface 410.
  • the boss 412 exemplarily shown in FIGS. 8a and 8b only
  • the implant member 115 includes an annular housing outer surface 306 located between the needle holder seat 302 and the sensor seat 304, and a proximal end of the annular outer surface 306 and along the diameter of the annular housing outer surface 306.
  • the flange 308 extends outward.
  • the diameter of the annular housing inner surface 410 of the clamping member 114 is configured to be greater than the annular housing outer surface 306 of the implant member 115, so that a portion of the annular housing outer surface 306 of the implant member 115 can be mounted to the clamping member 114 Inside the cavity formed by the inner surface 410 of the annular housing.
  • Fig. 6b shows a cross-sectional view of the clamping member 114 and the implanting member 115 after being clamped to each other.
  • the boss 412 of the clamping member 114 abuts the flange 308 of the implant member 115 to prevent the clamping member 114 and the implant member 115 from being separated from each other in the axial direction after being clamped.
  • the clamping member 114 is located in a clamping position relative to the implant member 115.
  • the clamping member 114 and the implanting member 115 can move axially relative to each other until the flange 308 abuts the bottom surface 414 (as shown in FIG. 8a), and the clamping member 114 is in a released position relative to the implanting member 115.
  • the clamping member 114 further includes an inner annular clamping surface 402, the position of which generally corresponds to the elastic pawls 302a-302c of the implant member 115, and is configured with a generally circular surface.
  • the size of the inner annular clamping surface 402 is set to be able to apply the aforementioned radial direction to the elastic pawls 302a-302c of the implant member 115 Internal force to hold the needle holder 114 in the needle holder seat 302.
  • the inner annular clamping surface 402 and the outer protrusions of the elastic pawls 302a-302c no longer contact each other, which makes the clamping member 115 no longer face the elastic pawls.
  • 302a-302c exert a radially inward force, and the elastic pawls 302a-302c no longer restrain the needle holder 113.
  • the needle holder 113 that has lost its restraint will move to the proximal side due to the elastic biasing force of the release spring 117, so that the needle holder 114 is released from the needle holder seat 302.
  • the implant member 115 includes a sensor base 304 on which the sensor assembly 500 can be mounted.
  • the sensor base 304 includes two pairs of radially symmetric elastic claws 310.
  • Each elastic claw 310 includes a clamping block 312 extending radially inward.
  • the elastic claw 310 can engage a corresponding structure on the sensor assembly 500 (the claw groove 503 described below with reference to FIG. 11) to connect the sensor assembly 500 is held in the sensor holder 304.
  • each elastic claw 310 further includes a working portion 314 and a releasing portion 316, the working portion 314 is configured to be closer to the proximal end relative to the releasing portion 316, and more radially outward relative to the releasing portion 316 prominent.
  • the clamping member further includes a claw engaging member 416 extending toward the distal end and positioned opposite to the two pairs of elastic claws 310 of the sensor base 304.
  • the claw engaging member 416 includes a claw engaging portion 418 located at the distal end and extending radially inward.
  • the claw engaging portion 418 abuts the release portion 316 of the elastic claw 310. At this time, the claw engaging portion 418 no longer applies a radially inward force to the elastic claw 310, which enables the sensor assembly 500 to be separated from the sensor seat 304.
  • the mutually contacting surfaces of the claw engaging portion 418 and the working portion 314 may be set as inclined surfaces, so that the claw engaging portion 418 can apply a stable radially inward force to the working portion 314, and A certain amount of force needs to be provided to move the pawl engaging portion 418 from the working portion 314 contacting the elastic pawl 310 to the releasing portion 316 contacting the elastic pawl 310.
  • FIG. 9 shows a schematic diagram after the clamping member 114 and the implant member 115 are clamped to each other, and the clamping member 114 is located in a clamping position relative to the implant member 115 at this time. It can be understood that in the configuration of FIG. 9, the claw engaging portion 418 of the clamping member 114 abuts the working portion (not shown) of the elastic claw 310 of the implant member 115, and the boss 412 of the clamping member 114 abuts The flange (not shown) of the implant member 115 is attached.
  • the inertial spring 116 is defined in the cavity formed by the clamping member 114 and the implant member 115, and one end thereof abuts the clamping member 114, and the other end abuts the implant member. 115.
  • the inertial spring 116 can transfer force from the clamping member 114 to the implant member 115 to drive the implant member 115 to move distally, so that the implant member 115 can gradually move to Release position.
  • the force between the driving spring 118 and the inertial spring 116 on both sides of the clamping member 114 is not balanced, that is, the driving force provided by the driving spring 118 It is temporarily still greater than the reverse biasing force provided by the inertial spring 116, which makes the clamping member 114 continue to move for a certain distance based on the inertial motion until it moves to the release position relative to the implant member 115.
  • the driving force provided by the driving spring 118 gradually decreases, and the inertial spring 116 is gradually compressed.
  • the clamping member 114 In the release position, since the clamping member 114 moves a certain distance toward the implant member 115, the clamping member 114 (specifically, the inner annular clamping surface 402) is no longer aligned with the elastic pawl 302a on the implant member 115. c, also no longer squeeze the elastic pawls 302a-302c radially inward. Since the restraint of the elastic pawls 302a-302c is released, the needle holder can be driven in the proximal direction by the release spring, thereby being released from the implant member 115 to the proximal end.
  • the driving force provided by the drive spring 118 moves the pawl engaging portion 418 from the working portion 314 contacting the elastic pawl 310 to contacting the elastic pawl 310
  • the release portion 316 of 310 allows the sensor assembly to be released from the sensor holder synchronously.
  • the cooperation between the claw engaging portion 418 and the working portion 314 of the elastic claw 310 also functions as the aforementioned inertial spring 116 as an inertial holding member, that is, when the needle insertion assembly 200 moves to approach the contact surface 106
  • the clamping member 114 is previously restricted from moving to the release position, and after the needle insertion assembly 200 is moved to a position close to the contact surface 106, the clamping member 114 is allowed to continue to move distally with respect to the implant member 115 by a predetermined distance until the clamping member 114 moves to the release position.
  • those skilled in the art can also use other types of inertial holding members as long as they can perform the same function.
  • the inertial spring 116 may not be used, and only the engagement of the claw coupling portion 418 and the elastic claw 310 is provided to realize the inertial protection function. Whether the function of the inertial spring 116 is mainly determined by whether the needle insertion assembly is moved to The contact surface is in contact with the skin.
  • the clamping member 114 further includes two firing retaining members 404 extending toward the proximal end, and each firing retaining member 404 includes a bayonet 406.
  • the firing catch member 404 extends into the radial through hole 210 of the contact housing 106, and when the firing member 110 is in the holding position (FIG. 4), the bayonet 406 of the firing catch member 404 engages the firing member 110 so as to clamp
  • the member 114 is restricted from moving distally, and when the firing member 110 is in the firing position (FIG. 5), the bayonet 406 of the firing holding member 404 is disengaged from the firing member 110, so that the holding member 114 can move distally .
  • the needle aid 100 may further include a driving spring 118 sleeved on the outside of the firing clamping member 404.
  • the contact housing 106 includes a shoulder 214, one end of the drive spring 118 abuts the shoulder 214, and the other end abuts the clamping member 114, and the firing member 110 and the firing retaining member 404 that are engaged with each other make the driving spring 118 is compressed between the shoulder 118 and the clamping member 114.
  • the firing member 110 moves to the firing position, the firing member 110 contacts and engages with the firing holding member 404.
  • the elastic biasing force of the driving spring 118 makes the clamping member 114 (and the entire needle insertion assembly) to the distal end mobile.
  • FIG. 4 shows the needle aid 100 in the initial state after the cover 104 is removed.
  • the user holds the cover 102 and puts the contact surface 206 of the contact housing 106 against the skin of the patient. At this time, the cover 102 and the contact housing 106 are in a locked position with each other.
  • FIG. 10 shows a schematic diagram of another state of the needle aid 100, in which the needle insertion assembly is moved to the distal end under the action of the drive spring 118, and the sensor assembly 500 carried on the needle insertion assembly moves to be close to the contact housing 106 Near the contact surface 206.
  • the implantation needle held by the needle holder 113 is implanted into the skin of the patient together with the sensor 502 of the sensor assembly 500.
  • the clamping member 114 is still in the clamping position to hold the needle holder 113 in the needle holder seat 302.
  • the elastic claw 310 of the sensor base 304 clamps the sensor assembly 500 at this time.
  • FIG. 11 shows a schematic diagram of another state of the needle aid 100, in which the clamping member 114 moves to the release position relative to the implant member 115 due to inertial motion. It can be understood that under the action of the driving spring 118, the clamping member 114 and the implanting member 115 move toward the distal end together. When the implant member 115 stops moving due to reaching the patient's skin, the clamping member 114 can still continue to move a certain distance to the distal end due to inertia, that is, the clamping member 114 moves from the clamping position relative to the implant member 115 (Fig. 10) Moved to the release position ( Figure 11). The inertial movement of the clamping member 114 compresses the inertial spring 116.
  • the clamping member 114 no longer applies radially inward force to the elastic pawls 302a-302c of the needle holder seat 302, at this time the needle holder 113 is disengaged from the needle holder seat 302 and moves proximally .
  • the implantation needle 111 and the needle holder 113 are moved proximally to evacuate the patient's skin, and the sensor 502 is indwelled under the patient's skin.
  • the spring performance of the inertial spring 116 and the driving spring 118 can be designed as required to meet the requirement of inertial movement for a certain distance.
  • the elastic claw 310 of the sensor base 304 releases the sensor assembly 500 at this time.
  • the user can remove the needle aid 100 from the patient's skin, and the sensor assembly 500 can be attached to the patient's skin, and the sensor 502 of the sensor assembly 500 can be left in the patient. Under the skin, it is used to detect the blood glucose concentration and other parameters in the patient’s blood.
  • an adhesive tape is provided on the side of the sensor assembly 500 close to the skin to adhere the sensor assembly 500 to the skin of the patient. Those skilled in the art can use any other common methods to attach the sensor assembly 500 to the patient's skin.
  • FIG. 12 shows a sensor assembly 500 according to an embodiment of the present application.
  • the sensor assembly 500 includes a claw groove 503 for accommodating the elastic claw 310 of the sensor holder 304, an implant needle holder 504 for accommodating the implant needle 111, an adhesive tape 506, and a transmitter 700 for engaging The card slot 507, the conductive mechanism 600, and the base 508 on which the conductive mechanism 600 is installed.
  • FIG. 13a shows the internal structure of the sensor assembly 500, in which the conductive mechanism 600 of the sensor assembly 500 is coupled to the sensor 502 mounted on the base 508, and the sensor 502 is connected to the sensor base plate 602 through the conductive double-sided adhesive 601.
  • the sensor base plate 602 is connected to the flexible circuit board 604, and the flexible circuit board 604 receives the detection result of the sensor 502.
  • FIG. 13b further shows the structure and connection relationship of the sensor 502, the conductive double-sided adhesive 601, the sensor base plate 602, and the flexible circuit board 604.
  • the conductive mechanism 600 of the sensor assembly 500 includes a conductive rubber 606, which is configured to be able to be electrically connected to the transmitter 700 installed to the sensor assembly 500 to transmit the detection result obtained by the sensor assembly 500 to the transmitter. ⁇ 700.
  • the conductive mechanism 600 of the sensor assembly 500 is coupled to a battery 510 installed on the base 508 as a power source.
  • the battery 510 is configured to provide power to the flexible circuit board 604 and the sensor 502.
  • the battery 510 may be contained in a battery compartment, and may be pre-installed in the battery compartment, or may be installed in the battery compartment after the sensor assembly is implanted subcutaneously.
  • the conductive mechanism 600 of the sensor assembly 500 further includes a pogo pin 514 and a conductive sheet 512 that electrically connects the pogo pin 514 to the battery 510.
  • the pogo pin 514 is configured to be electrically connected to the transmitter 700 corresponding to the sensor assembly 500, so that the battery 510 can supply power to the transmitter 700 after being electrically coupled to each other. It can be seen that, as a component that also has a certain service life, the battery 510 can be integrated on the sensor assembly 500, and can be removed from the patient's body together with the sensor when the sensor 500 is replaced. Correspondingly, other components of the blood glucose detection device, especially electronic components such as signal processing and transmission, can be integrated into another structure, and can be reused. This design method effectively reduces the cost of use.
  • FIG. 15 shows a schematic diagram of a transmitter 700 according to an embodiment of the present application.
  • the transmitter 700 includes a buckle 702 that engages with the groove 507 of the sensor assembly 500.
  • the buckle 702 can be used to connect the sensor assembly 500 and the transmitter 700.
  • the transmitter 700 also includes a first set of electrical contacts 704 and a second set of electrical contacts 706, where the first set of electrical contacts 704 is used to engage the conductive rubber 606 of the sensor assembly 500 to receive the data detected by the sensor 502, and the first set of electrical contacts 704 The two sets of electrical contacts 706 are used to engage the spring pins 514 of the sensor assembly 500 so that the battery 510 in the sensor assembly 500 can power the transmitter 700.
  • the transmitter 700 also includes an internal electrical component (not shown) for receiving and processing the detection result from the sensor 502, and sending the processed detection result and other data to an external receiver. It can be understood that electrical components may include various suitable electronic circuits, software, firmware, and chips to process signals and data, which is not limited in this application.
  • the transmitter 700 further includes a memory for storing the detection result received from the sensor 502. It can be understood that, in addition to the location of the battery (located on the sensor assembly), the mechanical structure of the transmitter 700 and the electrical connection structure between the transmitter 700 and the sensor assembly 500 can be adjusted in various ways as required, which is not limited in this application.
  • the needle aid 100 only engages the sensor assembly 500, and the transmitter 700 is installed on the sensor assembly 500 after the sensor assembly 500 is installed on the patient's skin. It can be understood that the needle aid 100 of the present application can also simultaneously join the integrated sensor assembly 500 and the transmitter 700, and simultaneously install the integrated sensor assembly and the transmitter 700 on the patient's skin. In some other embodiments, the needle aid 100 can also be used for percutaneous implantation of other types of implantable medical devices.
  • FIG. 16 shows a schematic diagram of a receiver 800 according to an embodiment of the present application.
  • the transmitter 700 can send data to the receiver in real time or at the request of the receiver 800, and the receiver 800 can use and process the data.
  • common communication methods can be used for data transmission between the transmitter 700 and the receiver 800, such as WiFi, Bluetooth, NFC, and RFID.
  • a separate transmitter 700 may be installed to the sensor assembly 500.
  • the transmitter 700 is powered by the battery 510 of the sensor assembly 500 and can receive data from the sensor assembly 500 and transmit the data to the receiver 800. It can be understood that after the end of each use period, the transmitter 700 can be removed from the sensor assembly 500 for use with another sensor assembly 500 in the next cycle.

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Abstract

本申请涉及一种用于经皮植入传感器的助针器，所述助针器包括：罩体、接触壳体、进针组件和击发组件。所述进针组件包括针保持器、植入构件和夹持构件。所述击发组件包括击发构件和驱动弹簧。所述夹持构件可相对于所述植入构件与所述针保持器从夹持位置移动至释放位置。所述进针组件还包括惯性保持构件，所述惯性保持构件被配置为在所述进针组件移动至接近所述接触面的位置之前限制所述夹持构件移动至释放位置，并且在所述进针组件移动至接近所述接触面的位置后允许所述夹持构件继续相对于所述植入构件向远端移动预定距离直至所述夹持构件移动至所述释放位置。

Description

助针器以及包括助针器的医疗系统 技术领域
本申请涉及血糖监测技术领域，更具体地涉及用于经皮植入传感器的助针器以及包括助针器的医疗系统。
背景技术
对于一名糖尿病患者，实时地监测血液中的血糖水平显得尤为重要。现有的血糖检测装置通常可以被贴附到患者的皮肤，并且血糖检测装置的传感器被经皮植入皮下，以连续地(例如14天)监测患者血液中的血糖水平。这种小型血糖检测装置通常还搭载发射器，以将传感器监测到的有关血糖水平的数据发射到接收器。患者可以在接收器上读取并处理数据，从而能够实时地了解体内血糖水平。
通常需要使用助针器将血糖检测装置的传感器植入到皮肤下方。助针器一般具有植入针，植入针的植入操作能够将植入针连同传感器一同植入皮肤下方；并且植入针的撤针操作能够将植入针快速撤出人体皮肤，而使得传感器留置在皮肤下方。因此，需要提供一种助针器来快速、稳定地实现植入针的植入操作和撤针操作。
此外，血糖检测装置通常是一次性医疗用具，在每个使用周期结束后，包括传感器和发射器的血糖检测装置一些组件就需要被丢弃。因此，如何重复地利用血糖检测装置的组件以降低使用成本，也是一个需要解决的问题。
发明内容
本申请提供一种用于经皮植入传感器的助针器。所述助针器包括：罩体；接触壳体，所述接触壳体至少部分地套设在所述罩体内部，其中所述接触壳体具有位于其远端的用于接触患者皮肤的接触面；进针组件，所述进针组件被容纳在所述接触壳体内部并且用于承载包括所述传感器的传感器组件，所述进针组件能够从远离所述接触面的位置移动至接近所述接触面的位置以将所述传感器经皮植入患者皮肤下方。所述进针组件包括：针保持器， 所述针保持器用于保持植入针；植入构件，所述植入构件包括位于其远端侧的用于可释放地容纳所述传感器组件的传感器座，以及位于其近端侧的用于可释放地容纳所述针保持器的针保持器座；和夹持构件，所述夹持构件耦接到所述植入构件，并且可释放地夹持所述针保持器座；其中，所述夹持构件可相对于所述植入构件与所述针保持器从夹持位置移动至释放位置；在所述夹持位置，所述夹持构件向所述针保持器座施加夹持力以将针保持器容纳在所述针保持器座中，而在所述释放位置，所述夹持构件不再向所述针保持器座施加夹持力，从而使得所述针保持器座释放所述针保持器，以使所述针保持器能够向近端方向移动。所述助针器还包括击发组件，所述击发组件用于保持所述进针组件处于远离所述接触面的位置，并且响应于击发触动动作将所述进针组件从远离所述接触面的位置移动至接近所述接触面的位置。所述击发组件包括：击发构件，所述击发构件用于接收击发触动动作，并且响应于所述击发触动动作从保持位置移动至击发位置；其中，在所述保持位置，所述击发构件将所述进针组件保持在远离所述接触面的位置，而在所述击发位置，所述击发构件允许所述进针组件向接近所述接触面的位置移动；以及驱动弹簧，响应于所述击发构件处于所述保持位置，所述驱动弹簧由所述击发构件和所述夹持构件保持在压缩状态，并且响应于所述击发构件处于所述击发位置，所述驱动弹簧驱动所述进针组件移动至接近所述接触面的位置。
本申请还提供一种医疗系统，所述医疗系统包括：前述的助针器；包括所述传感器和用于安装电池的电池仓的所述传感器组件；以及独立于所述助针器和所述传感器组件的发射器。所述传感器组件可拆卸地接合于所述助针器的所述进针组件，并且当所述进针组件连同所述传感器组件移动至接近所述接触面的位置时，所述传感器经皮植入患者皮肤下方并且所述传感器组件脱离所述进针组件而被滞留在患者皮肤上。当所述传感器组件脱离所述进针组件而被滞留在患者皮肤上后，所述发射器接合所述传感器组件并且电耦接到所述传感器与所述电池，以由所述电池向所述电气组件供电并且由所述电气组件接收并处理所述传感器的检测结果；并且所述发射器向外部发送所述检测结果。
本申请还提供一种医疗系统，所述医疗系统包括：传感器组件和具有电气组件的发射器。所述传感器组件包括用于经皮检测血糖水平的传感器以及用于安装电池的电池仓。所述发射器可拆卸地耦接到所述传感器组件，当所述传感器组件被安装在患者皮肤上后，所述发射器能够接合所述传感器组件并电耦接到所述传感器与所述电池， 以由所述电池向所述电气组件供电并且由所述电气组件接收并处理所述传感器的检测结果。所述发射器向外部发送所述检测结果。
以上为本申请的概述，可能有简化、概括和省略细节的情况，因此本领域的技术人员应该认识到，该部分仅是示例说明性的，而不旨在以任何方式限定本申请范围。本概述部分既非旨在确定所要求保护主题的关键特征或必要特征，也非旨在用作为确定所要求保护主题的范围的辅助手段。
附图说明
通过下面说明书和所附的权利要求书并与附图结合，将会更加充分地清楚理解本申请内容的上述和其他特征。可以理解，这些附图仅描绘了本申请内容的若干实施方式，因此不应认为是对本申请内容范围的限定。通过采用附图，本申请内容将会得到更加明确和详细地说明。
图1a和1b分别示出了根据本申请一个实施例的助针器的示意图和横截面图；
图2示出了图1a和1b中的助针器的爆炸图，其示出了助针器内部的各个部件；
图3a和3b示出了根据本申请一个实施例的接触壳体的示意图和横截面图；
图4示出了去除盖体后的处于初始状态的助针器的横截面图；
图5示出了助针器，其中接触壳体和罩体相互之间处于解锁位置，并且使用者的击发操作使得击发构件移动至击发位置；
图6a和6b示出了根据本申请一个实施例的进针组件的不同横截面的横截面图；
图7a和7b示出了根据本申请一个实施例的植入构件；
图8a和8b示出了根据本申请一个实施例的夹持构件；
图9示出了夹持构件与植入构件相互卡接之后的示意图；
图10示出了助针器，其中进针组件在驱动弹簧的作用下移动至远端；
图11示出了助针器，其中夹持构件由于惯性相对于植入构件移动至释放位置；
图12示出了根据本申请一个实施例的传感器组件；
图13a示出了传感器组件的内部结构；
图13b示出了传感器、导电双面胶、传感器底板和柔性电路板的结构和连接关系；
图14示出了传感器组件的内部结构；
图15示出了根据本申请一个实施例的发射器的示意图；以及
图16示出了根据本申请一个实施例的接收器的示意图。
在详细解释本发明的任何实施例之前，应该理解，本发明的应用不限于在下面的描述中阐述的或在以下附图中示出的构造的细节和部件的布置。本发明能够具有其他实施例并且能够以各种方式实践或实施。而且，应该理解，这里使用的措辞和术语是为了描述的目的，不应被认为是限制性的。
具体实施方式
在下面的详细描述中，参考了构成其一部分的附图。在附图中，类似的符号通常表示类似的组成部分，除非上下文另有说明。详细描述、附图和权利要求书中描述的说明性实施方式并非旨在限定。在不偏离本申请的主题的精神或范围的情况下，可以采用其他实施方式，并且可以做出其他变化。可以理解，可以对本申请中一般性描述的、在附图中图解说明的本申请内容的各个方面进行多种不同构成的配置、替换、组合，设计，而所有这些都明确地构成本申请内容的一部分。
图1a和1b分别示出了根据本申请一个实施例的助针器100的外部构造示意图以及截面示意图。其中，根据具体使用阶段的不同，助针器100的内部结构和部件相对位置可能有所不同，图1b是助针器100处于初始状态的截面示意图，其处于操作过程中其他状态下的内部构造会在其他附图中描述。在一些实施例中，图1a和1b所示的助针器100可以用于经皮植入血糖检测装置的传感器，其可以构造为位于例如图10所示的传感器组件500上。
如图1a和1b所示，助针器100包括相互连接的罩体102和盖体104，其例如通过螺纹或卡扣连接方式相互连接。罩体102与盖体104相互连接后限定了密闭空间，其中可以容纳助针器的各个部件，以及传感器(图中未示出)。由于传感器需要被经皮植入皮下，因此助针器100的内部密闭空间提供了隔离外部细菌和其他污染源的洁净空间，便于传感器的封装与保存。
图2示出了图1a和1b中的助针器100的爆炸图，其示出了助针器100内部的各 个部件。下文将结合图1b、图2以及其它附图具体描述助针器100内部各个部件的结构以及功能。
如图1b和2所示，助针器100包括套设在罩体102内部的接触壳体106。图3a和3b示出了根据本申请一个实施例的接触壳体106的立体图和横截面图。如图3a和3b所示，接触壳体106包括桶状的壳体部分201以及绕壳体部分201周向分布的凸棱202。当接触壳体106被安装在罩体102中时，凸棱202与罩体102内表面处的凹槽(未示出)相互配合，以限制接触壳体106和罩体102相互之间的沿周向旋转，特别是在植入传感器的过程中。接触壳体106还包括绕壳体部分201周向分布并与凸棱202间隔设置的凸块204。当接触壳体106被安装在罩体102中时，凸块204嵌入罩体102中的具有预定轴向长度的伸长形的开口205，以防止接触壳体106脱离罩体102。开口205具有比凸块204更长的轴向长度，从而允许凸块204在其中轴向滑动。这样，接触壳体106和罩体102至多能够在轴向上相对移动预定距离，而不会过度移动直至相互脱离。需要说明的是，图3中仅示意性地示出了接触壳体106上具有2个凸棱202和2个凸块204，本领域技术人员可以根据需要设置不同数量的凸棱和凸块，本申请对此不作限制。在一些实施例中，也可以在罩体102的内表面设凸棱和凸块，并且在接触壳体106上设置对应的凹槽与开口。在另一些实施例中，接触壳体与罩体之间也可以通过其他构造来避免沿周向的转动和/或沿轴向的过度滑动。例如，可以通过将罩体与接触壳体设置为具有大体匹配的椭圆形形状来避免周向转动。
接触壳体106包括位于其远端的用于接触患者皮肤的接触面206。可以理解，当从助针器100移除盖体104后，使用者(例如患者)可以移动助针器100并将该接触面206抵靠在患者的皮肤表面，然后再进行后续操作。本申请中的近端、近端侧是指当被正常操作(植入传感器操作)时，助针器或其各个部件相对靠近使用者的一端，而远端、远端侧指的是助针器或其各个部件相对远离使用者的一端。
继续参考图1b和图2，助针器100还包括被压缩在接触壳体106和罩体102之间的锁定弹簧108。锁定弹簧108的一端被安装在接触壳体106的锁定弹簧座208(图3a和3b)中，另一端抵靠罩体102近端的内表面。在一些实施例中，罩体102近端的内表面也可以具有耦接锁定弹簧108的弹簧座。这样，锁定弹簧108可以被设置为仅能够沿轴向压缩或伸长，并且在轴向伸长时向接触壳体106以及其他相耦接的部件提供轴向移动的驱动力。
图4示出了去除盖体104后的处于初始状态的助针器100的截面示意图。在初始状态下，助针器100被锁定而不能够进行传感器的植入动作。如图4所示，在初始状态，锁定弹簧108处于压缩状态，其提供的弹性偏置力使得接触壳体106的凸块204保持在罩体102的开口205内的最远端的位置，但是植入针也保持在罩体102内部。此时接触壳体106和罩体102相互之间处于锁定位置。当受到进一步压缩锁定弹簧108的外部驱动力(参见图5)的作用时，接触壳体106可以沿轴向移动而进一步接近罩体102，这使得凸块204可以在开口205内滑动直至处于开口205内最近端的位置。此时接触壳体106和罩体102相互之间处于解锁位置(如下文参考图5的描述)。
继续参考图4，助针器100还包括击发构件110，击发构件110延伸穿过接触壳体106的径向通孔210(图3a和3b)，并且击发构件110的第一端经由罩体102的开口120(该开口120大体与径向通孔210对准)延伸穿出罩体102，以方便使用者对击发构件110进行击发操作。在一个实施例中，击发构件110在第一端处设置有凹槽121，当接触壳体106和罩体102相互之间处于锁定位置(即图4所示的位置)时，凹槽121在开口120处被卡持在罩体102的卡持部122上，从而击发构件110被限制在保持位置以防止使用者进行击发操作。在使用者施加外部驱动力，克服锁定弹簧108以使得接触壳体106和罩体102在轴向上相互移动至解锁位置时，卡持部122相对远离凹槽121移动至不再卡持凹槽121的位置，这使得使用者能够通过击发操作来将击发构件110移动至击发位置(如下文参考图5的描述)。
可以看出，击发构件110和罩体102的相互配合使得助针器100可操作地处于解锁位置与锁定位置，特别是设置锁定位置可以避免助针器100因为使用者的误操作而被不恰当地击发，从而减少了使用故障和风险。在一些实施例中，也可以简化设计而不采用上述用于锁定的机构，这种情况下助针器100可以初始地处于图5所示的解锁位置，但击发构件110处于非击发位置，也即未被使用者向内按压至击发位置。
图5示出了助针器100处于不同于图1b和图4的另一状态的示意图，其中接触壳体106和罩体102相互之间处于解锁位置，并且使用者按压击发构件110的击发操作使得击发构件110移动至击发位置。
参考图5所示，助针器100还包括击发弹簧112，击发弹簧112的一端被安装至接触壳体106的击发弹簧座212(图3)，另一端连接至击发构件110的第一端。击发弹簧112被压缩在接触壳体106和击发构件110之间，当使用者不再向击发构件 110施加力时，该击发弹簧112提供回复力迫使击发构件110从击发位置回到保持位置，也即沿图5中所示的方向2相反的方向移动。在一些实施例中，助针器100可以是一次性使用设备，也即击发构件110在移动至击发位置后不需要再向外移动返回到非击发位置；相应地，可以不设置击发弹簧。
继续参考图2和4，助针器100还包括安装在接触壳体106内部的进针组件。图6a示出了沿着图4的角度的进针组件200的横截面图，图6b示出了从图4绕轴向旋转90度后的进针组件200的横截面图。如图6a和6b所示，进针组件包括植入针111、针保持器113、夹持构件114、植入构件115、惯性弹簧116和释放弹簧117。
具体地，针保持器113被配置成保持植入针，以使得植入针能够随针保持器113的运动而运动。释放弹簧117被容纳在针保持器113的内部空腔中，并且其两端分别耦接到针保持器113和植入构件115，以使得针保持器113被可释放地耦接到植入构件115上。在未释放前，释放弹簧117被针保持器113与植入构件115压缩。
图7a和7b示出了根据本申请一个实施例的植入构件115的侧面示意图。如图7a和7b所示，植入构件115包括位于其近端侧的用于可释放地容纳针保持器113的针保持器座302。针保持器座302可以包括三个弹性棘爪302a-302c，这三个弹性棘爪302a-302c围成了一个用于容纳针保持器113的腔室。当容纳有压缩状态的释放弹簧117的针保持器113被安装在针保持器座302中时，通过在弹性棘爪302a-302c的最外端施加径向向内的力，例如从位于弹性棘爪302a-302c外围的夹持构件114的对应位置(这将在下文中详述)向内的力，可以使得针保持器113抵抗释放弹簧117的弹性偏置力而被弹性棘爪302a-302c保持在针保持器座302内。可以理解，当前述的径向向内的力被撤销时，弹性棘爪302a-302c不再约束针保持器302，这使得针保持器113受到释放弹簧117的弹性偏置力而向近端侧远离植入构件115移动，从而使得针保持器113从针保持器座302中释放，这进一步带动植入针远离接触皮肤的接触面206，从而使得植入针从皮下撤出。此外，植入构件115还包括位于其远端侧的用于可释放地容纳传感器组件500的传感器座304。在一些实施例中，传感器组件500可以大体稳定地安装到传感器座304上，并且在接触皮肤后与皮肤粘接在一起，其粘附力足以克服传感器组件500与传感器座304之间的夹持力/摩擦力，以允许传感器组件500脱离传感器座304。下文将结合夹持构件114具体描述植入构件115的传感器座304的结构和工作原理。
图8a-8b示出了根据本申请一个实施例的夹持构件114。如图8a-8b所示，夹持构件114包括环形壳体内表面410，以及位于环形内表面410的远端且沿环形壳体内表面410径向向内延伸的凸台412。图8a和8b中示例性示出的凸台412仅在环形壳体内表面410上周向延伸了一部分周长。在其它实施例中，凸台412可以在环形壳体内表面410上周向延伸更多或更少的部分。对应的，参考图7a和7b，植入构件115包括位于针保持器座302和传感器座304之间的环形壳体外表面306，以及位于环形外表面306的近端且沿环形壳体外表面306径向向外延伸的凸缘308。夹持构件114的环形壳体内表面410的直径被构造成大于植入构件115的环形壳体外表面306，以使得植入构件115的环形壳体外表面306的部分可以被安装到夹持构件114的环形壳体内表面410形成的空腔内。
图6b示出了夹持构件114和植入构件115在相互卡接后的横截面图。如图6b所示，此时夹持构件114的凸台412抵接植入构件115的凸缘308，以防止卡接之后的夹持构件114和植入构件115在轴向上彼此脱离。此时，夹持构件114相对于植入构件115位于夹持位置。进一步地，夹持构件114和植入构件115能够相对于彼此轴向移动直到凸缘308抵靠底面414(如图8a所示)，夹持构件114相对于植入构件115位于释放位置。
继续参考图6b和8a，夹持构件114还包括内环形夹持面402，其位置大体对应于植入构件115的弹性棘爪302a-302c，并且被构造大体呈环形的表面。当夹持构件114相对于植入构件115处于夹持位置时，内环形夹持面402的尺寸被设置成能够向植入构件115的弹性棘爪302a-302c施加如前所述的径向向内的力，以将针保持器114保持在针保持器座302内。当夹持构件114相对于植入构件115处于释放位置时，内环形夹持面402与弹性棘爪302a-302c的外侧凸起不再相互接触，这使得夹持构件115不再向弹性棘爪302a-302c施加径向向内的力，弹性棘爪302a-302c也不再约束针保持器113。如前所述，此时，失去约束的针保持器113会由于释放弹簧117的弹性偏置力而向近端侧移动，从而使得针保持器114从针保持器座302中释放。
如前所述，植入构件115包括可以安装传感器组件500的传感器座304。如图7a和7b所示，传感器座304包括两对径向对称的弹性卡爪310。每个弹性卡爪310均包括径向向内延伸的卡持块312。当在弹性卡爪310上施加径向向内的外力时，弹性卡爪310能够接合传感器组件500上的对应的结构(如下文参考图11的描述的卡爪 凹槽503)，以将传感器组件500保持在传感器座304中。
进一步参考图7a和7b，每个弹性卡爪310还包括工作部314和释放部316，工作部314被构造成相对于释放部316更接近近端，并且相对于释放部316更加径向向外突出。
进一步参考图8a和8b，夹持构件还包括朝远端延伸的且位置与传感器座304的两对弹性卡爪310相对的卡爪接合件416。卡爪接合件416包括位于远端且径向向内延伸的卡爪接合部418。当夹持构件114相对于植入构件115位于夹持位置时，卡爪接合部418抵接弹性卡爪310的工作部314(如图6b所示)。此时卡爪接合部418向工作部314施加径向向内的力，以使得卡持块312能够卡持传感器组件500。当夹持构件114相对于植入构件115移动至释放位置时，卡爪接合部418抵接弹性卡爪310的释放部316。此时卡爪接合部418不再向弹性卡爪310施加径向向内的力，这使得传感器组件500能够脱离传感器座304。在某一实施例中，卡爪接合部418和工作部314的相互接触的表面可以设置为倾斜表面，以使得卡爪接合部418能向工作部314施加稳定的径向向内的力，并且需要提供一定大小的力才能将卡爪接合部418从抵接弹性卡爪310的工作部314移动至抵接弹性卡爪310的释放部316。
图9示出了夹持构件114与植入构件115相互卡接之后的示意图，并且此时夹持构件114相对于植入构件115位于夹持位置。可以理解，在图9的构造中，夹持构件114的卡爪接合部418抵接植入构件115的弹性卡爪310的工作部(未示出)，并且夹持构件114的凸台412抵接植入构件115的凸缘(未示出)。
继续参考图2和图4，惯性弹簧116被限定在相互卡接的夹持构件114和植入构件115所形成的腔室内，并且其一端抵接夹持构件114，另一端抵接植入构件115。当植入构件115相对“自由”移动时，惯性弹簧116能够从夹持构件114向植入构件115传递作用力，以驱动植入构件115向远端移动，从而植入构件115能够逐渐移动至释放位置。另一方面，当植入构件115抵触皮肤而不能够“自由”移动时，夹持构件114两侧的驱动弹簧118与惯性弹簧116之间的力未平衡，也即驱动弹簧118提供的驱动力暂时仍大于惯性弹簧116提供的反向的偏置力，这使得夹持构件114基于惯性运动继续移动一段距离，直至相对于植入构件115移动至释放位置。在此过程中，驱动弹簧118提供的驱动力逐渐减小，而惯性弹簧116被逐渐压缩。在释放位置，由于夹持构件114朝向植入构件115移动一定距离，这使得夹持构件114(具体地，内 环形夹持面402)不再对准植入构件115上的弹性棘爪302a-c，也不再径向向内挤压弹性棘爪302a-302c。由于解除了弹性棘爪302a-302c的约束，针保持器可以被释放弹簧向近端方向驱动，从而脱离植入构件115向近端释放。可以理解，在夹持构件114基于惯性运动继续移动一段距离的过程中，驱动弹簧118提供的驱动力将卡爪接合部418从抵接弹性卡爪310的工作部314移动至抵接弹性卡爪310的释放部316，从而允许传感器组件能够同步地从传感器座释放。
可以理解，卡爪接合部418和弹性卡爪310的工作部314之间的配合，同样起到了前述的惯性弹簧116作为惯性保持构件的功能，即：在进针组件200移动至接近接触面106的位置之前限制夹持构件114移动至释放位置，并且在进针组件200移动至接近接触面106的位置后允许夹持构件114继续相对于植入构件115向远端移动预定距离直至夹持构件114移动至释放位置。此外，本领域技术人员也可以采用其它类型的惯性保持构件，只要能起到该相同的功能即可。可以理解，在一些实施例中，惯性弹簧116可以不被采用，而仅提供卡爪结合部418与弹性卡爪310的配合来实现惯性保护功能，其是否作用主要取决于进针组件是否移动到接触面接触皮肤。
如图8a和8b所示，夹持构件114还包括两根朝近端延伸的击发卡持构件404，每个击发卡持构件404包括卡口406。击发卡持构件404延伸进入接触壳体106的径向通孔210，并且当击发构件110处于保持位置时(图4)，击发卡持构件404的卡口406啮合击发构件110，以使得夹持构件114被限制向远端移动，并且当击发构件110处于击发位置时(图5)，击发卡持构件404的卡口406与击发构件110解除啮合，以使得夹持构件114能够向远端移动。回到图4，助针器100还可以包括套设在击发卡持构件404外侧的驱动弹簧118。在一个实施例中，接触外壳106包括台肩214，驱动弹簧118的一端抵接台肩214，另一端抵接夹持构件114，而相互啮合的击发构件110和击发卡持构件404使得驱动弹簧118被压缩在台肩118和夹持构件114之间。进一步地，当击发构件110移动至击发位置时，击发构件110与击发卡持构件404接触啮合，此时驱动弹簧118的弹性偏置力使得夹持构件114(以及整个进针组件)向远端移动。
以上结合附图1-8描述了助针器100的各个部件的结构以及相互之间的配置关系。以下将结合额外的附图进一步描述助针器100的操作流程和工作原理。
首先参考图4，图4示出了去除盖体104后的处于初始状态的助针器100。使用 者手持罩体102，并将接触壳体106的接触面206抵接患者的皮肤。此时，罩体102和接触壳体106相互之间处于锁定位置。
进一步参考图5，当接触壳体106的接触面206抵接患者的皮肤后，使用者以方向1下压罩体102，以使得罩体102和接触壳体106从锁定位置移动至解锁位置。此时使用者可以以方向2按下击发构件110，以使得击发构件110从保持位置移动至击发位置。在击发构件110移动至击发位置后，夹持构件114的击发卡持构件404与击发构件110解除啮合，这使得处于压缩状态的驱动弹簧118能够驱动夹持构件114(以及整个进针组件)向远端移动。
图10示出了助针器100另一状态的示意图，其中进针组件在驱动弹簧118的作用下移动至远端，并且被承载在进针组件上的传感器组件500移动至靠近接触壳体106的接触面206附近。此时，由针保持器113保持的植入针连同传感器组件500的传感器502一起被植入患者的皮肤。可以看到，在图10所示的助针器100中，夹持构件114仍处于夹持位置，以将针保持器113保持在针保持器座302中。此外，如前所述，此时传感器座304的弹性卡爪310卡持传感器组件500。
图11示出了助针器100又一状态的示意图，其中夹持构件114由于惯性运动相对于植入构件115移动至释放位置。可以理解，在驱动弹簧118的作用下，夹持构件114和植入构件115一同朝向远端移动。当植入构件115由于抵达患者的皮肤而停止运动后，夹持构件114仍能够由于惯性而继续向远端移动一段距离，也即夹持构件114相对于植入构件115从夹持位置(图10)移动到了释放位置(图11)。夹持构件114的惯性运动会压缩惯性弹簧116。在释放位置，夹持构件114不再向针保持器座302的弹性棘爪302a-302c施加径向向内的力，此时针保持器113从针保持器座302中脱离，并向近端移动。如图11所示，植入针111连同针保持器113一起向近端移动，以撤离患者的皮肤，而传感器502则留置在患者的皮肤下方。可以理解，惯性弹簧116以及驱动弹簧118的弹簧性能可以根据需要进行设计，以满足惯性移动一定距离的要求。此外，如前所述，此时传感器座304的弹性卡爪310释放传感器组件500。
在如图11所示的完成撤针之后，使用者可以从患者皮肤拿开助针器100，而传感器组件500能够附接在患者的皮肤上，并且传感器组件500的传感器502能过留置在患者的皮肤下方，以用于检测患者的血液中的血糖浓度等参数。在一个实施例中，传感器组件500靠近皮肤的一侧设置有贴附胶带，以将传感器组件500粘附在患者的皮 肤上。本领域技术人员可以采用其它任何的常见的方式将传感器组件500附接到患者的皮肤上。
图12示出了根据本申请一个实施例的传感器组件500。如图12所示，传感器组件500包括用于容纳传感器座304弹性卡爪310的卡爪凹槽503、容纳植入针111的植入针座504、贴附胶带506、用于啮合发射器700的卡槽507、导电机构600以及安装导电机构600的底座508。
图13a示出了传感器组件500的内部结构，其中传感器组件500的导电机构600耦接到安装在底座508上的传感器502，传感器502通过导电双面胶601连接至传感器底板602。传感器底板602连接至柔性电路板604，柔性电路板604接收由传感器502的检测结果。图13b进一步示出了传感器502、导电双面胶601、传感器底板602和柔性电路板604的结构和连接关系。
如图13a所示，传感器组件500的导电机构600包括导电橡胶606，导电橡胶606配置成能够与安装至传感器组件500对应的发射器700电连接，以将传感器组件500获得的检测结果传输至发射器700。
图14示出了传感器组件500的内部结构，其中传感器组件500的导电机构600耦接到安装在底座508上作为电源使用的电池510，电池510被配置成为柔性电路板604以及传感器502供电。电池510可以被容纳在电池仓中，并且可以被预先安装在电池仓中，或者可以在传感器组件植入皮下后再安装在电池仓中。此外，传感器组件500的导电机构600还包括弹簧针514，以及将弹簧针514电连接至电池510的导电片512。弹簧针514被配置成能够与安装至传感器组件500对应的发射器700电连接，以使得相互电耦接后，电池510能够为发射器700供电。可以看出，作为同样具有一定使用寿命的部件，电池510可以被集成在传感器组件500上，并且可以在传感器500更换时一同与传感器从患者身体上去除。相应地，血糖检测装置的其他部件，特别是信号处理、发射等电子部件可以被集成在另外的结构上，并且可以重复使用。这种设计方式有效降低了使用成本。
图15示出了根据本申请一个实施例的发射器700的示意图。如图15所示，发射器700包括啮合传感器组件500卡槽507的卡扣702。本领域技术人员可以理解，除了卡槽507和卡扣702之外，可以使用其它常用的连接结构来连接传感器组件500和发射器700。
发射器700还包括第一组电触点704和第二组电触点706，其中第一组电触点704用于接合传感器组件500的导电橡胶606，以接收传感器502检测的数据，而第二组电触点706用于接合传感器组件500的弹簧针514，以使得传感器组件500中的电池510能够为发射器700供电。此外，发射器700还包括安装在内部的电气组件(未示出)，以用于从传感器502接收并处理检测结果，并将处理后的检测结果以及其他数据发送给外部的接收器。可以理解，电气组件可以包括各种适合的电子电路、软件、固件、芯片来处理信号和数据，本申请不对此进行限制。在某些实施例中，发射器700还包括存储器，以用于存储从传感器502接收的检测结果。可以理解，除了电池所在位置(位于传感器组件上)之外，发射器700的机械结构以及其与传感器组件500之间的电气连接结构可以根据需要进行各种调整，本申请不对此进行限制。
在上面描述的实施例中，助针器100仅接合传感器组件500，并在传感器组件500被安装在患者皮肤上后将发射器700安装在传感器组件500上。可以理解，本申请的助针器100也可以同时接合一体的传感器组件500和发射器700，并同时将一体的传感器组件和发射器700安装到患者皮肤上。在一些其他的实施例中，助针器100也可用于经皮植入其他类型的植入式医疗设备。
图16示出了根据本申请一个实施例的接收器800的示意图。发射器700能够实时地或在接收器800的请求下向接收器发送数据，并接收器800能够对该数据进行使用和处理。本领域技术人员可以理解，可以使用常见的通信方式用于发射器700和接收器800之间的数据传输，例如WiFi、蓝牙、NFC和RFID等。
在传感器502被植入患者的皮肤下方并且传感器组件500被贴附到患者皮肤后，独立的发射器700可以被安装至传感器组件500。发射器700由传感器组件500的电池510供电，并且可以接收来自传感器组件500的数据并将数据发射至接收器800。可以理解，在每个使用周期结束后，可以从传感器组件500上拆下发射器700，以用于在下个周期与另一个传感器组件500一起使用。
尽管已经参考某些优选实施例详细描述了本发明，但是在所描述的本发明的一个或多个独立方面的范围和精神内存在各种变化和修改。
本技术领域的一般技术人员可以通过研究说明书、公开的内容及附图和所附的权利要求书，理解和实施对披露的实施方式的其他改变。在权利要求中，措词“包括”不排除其他的元素和步骤，并且措辞“一”、“一个”不排除复数。在本申请的实际 应用中，一个零件可能执行权利要求中所引用的多个技术特征的功能。权利要求中的任何附图标记不应理解为对范围的限制。

Claims (16)

  1. 一种用于经皮植入传感器的助针器，其特征在于，所述助针器包括：
    罩体；
    接触壳体，所述接触壳体至少部分地套设在所述罩体内部，其中所述接触壳体具有位于其远端的用于接触患者皮肤的接触面；
    进针组件，所述进针组件被容纳在所述接触壳体内部并且用于承载包括所述传感器的传感器组件，所述进针组件能够从远离所述接触面的位置移动至接近所述接触面的位置以将所述传感器经皮植入患者皮肤下方；其中，所述进针组件包括：
    针保持器，所述针保持器用于保持植入针；
    植入构件，所述植入构件包括位于其远端侧的用于可释放地容纳所述传感器组件的传感器座，以及位于其近端侧的用于可释放地容纳所述针保持器的针保持器座；和
    夹持构件，所述夹持构件耦接到所述植入构件，并且可释放地夹持所述针保持器座；其中，所述夹持构件可相对于所述植入构件与所述针保持器从夹持位置移动至释放位置；在所述夹持位置，所述夹持构件向所述针保持器座施加夹持力以将针保持器容纳在所述针保持器座中，而在所述释放位置，所述夹持构件不再向所述针保持器座施加夹持力，从而使得所述针保持器座释放所述针保持器，以使所述针保持器能够向近端方向移动；以及
    击发组件，所述击发组件用于保持所述进针组件处于远离所述接触面的位置，并且响应于击发触动动作将所述进针组件从远离所述接触面的位置移动至接近所述接触面的位置，其中，所述击发组件包括：
    击发构件，所述击发构件用于接收击发触动动作，并且响应于所述击发触动动作从保持位置移动至击发位置；其中，在所述保持位置，所述击发构件将所述进针组件保持在远离所述接触面的位置，而在所述击发位置，所述击发构件允许所述进针组件向接近所述接触面的位置移动；以及
    驱动弹簧，当所述击发构件处于所述保持位置，所述驱动弹簧由所述击发构件和所述夹持构件保持在压缩状态，并且当所述击发构件处于所述击发位置，所 述驱动弹簧驱动所述进针组件移动至接近所述接触面的位置。
  2. 根据权利要求1所述的助针器，其特征在于，所述进针组件还包括惯性保持构件，所述惯性保持构件被配置为在所述进针组件移动至接近所述接触面的位置之前限制所述夹持构件移动至释放位置，并且在所述进针组件移动至接近所述接触面的位置后允许所述夹持构件继续相对于所述植入构件向远端移动预定距离直至所述夹持构件移动至所述释放位置。
  3. 根据权利要求2所述的助针器，其特征在于，所述惯性保持构件是惯性弹簧。
  4. 根据权利要求1或2所述的助针器，其特征在于，所述夹持构件包括卡爪接合件，并且所述植入构件的传感器座包括弹性卡爪，所述卡爪接合件和所述弹性卡爪被配置成在所述进针组件移动至接近所述接触面的位置之前限制所述夹持构件移动至释放位置，并且在所述进针组件移动至接近所述接触面的位置后允许所述夹持构件继续相对于所述植入构件向远端移动预定距离直至所述夹持构件移动至所述释放位置。
  5. 根据权利要求1所述的助针器，其特征在于，在所述驱动弹簧驱动所述进针组件移动至接近所述接触面的位置的过程中，所述进针组件独立于所述接触壳体移动。
  6. 根据权利要求1所述的助针器，其特征在于，所述针保持器座具有多个棘爪，所述多个棘爪沿所述针保持器座的周向分布，并且在所述夹持构件施加的夹持力作用下朝向所述针保持器形变。
  7. 根据权利要求1所述的助针器，其特征在于，所述助针器还包括：
    锁定弹簧，所述锁定弹簧被设置于所述接触壳体与所述罩体之间；
    其中，所述接触壳体能够相对于所述罩体在锁定位置与解锁位置相互移动；在所 述锁定位置，所述锁定弹簧提供偏置力限制所述接触壳体与所述罩体相互靠近，在所述解锁位置，所述罩体受外部驱动力作用克服所述锁定弹簧的偏置力而使得所述接触壳体与所述罩体相互靠近；
    其中，在所述锁定位置，所述击发构件被限制响应于所述击发触动动作而动作；在所述解锁位置，所述击发构件被允许响应于所述击发触动动作而动作。
  8. 根据权利要求1所述的助针器，其特征在于，所述进针组件包括：
    释放弹簧，其被压缩在所述针保持器与所述针保持器座之间，用于在所述夹持构件处于所述释放位置时驱动所述针保持器从所述针保持器座中释放并向近端移动。
  9. 根据权利要求1所述的助针器，其特征在于，所述罩体具有击发开口，所述击发开口用于允许所述击发构件的一部分穿过所述罩体以接收所述击发触动动作。
  10. 根据权利要求9所述的助针器，其特征在于，所述进针组件还包括：
    击发弹簧，其耦接在所述接触壳体和所述击发构件之间，用于迫使所述击发构件从所述击发位置回到所述保持位置。
  11. 根据权利要求1所述的助针器，其特征在于，所述植入构件与所述夹持构件相互卡接，以防止所述植入构件脱离所述夹持构件。
  12. 根据权利要求4所述的助针器，其特征在于，在所述夹持位置，所述卡爪接合件向所述弹性卡爪施加夹持力以将所述传感器组件容纳在所述传感器座中，而在所述释放位置，所述卡爪接合件不再向所述弹性卡爪施加夹持力，从而使得所述传感器释放所述传感器组件。
  13. 一种医疗系统，其特征在于，所述医疗系统包括：
    权利要求1所述的助针器；
    包括所述传感器和用于安装电池的电池仓的所述传感器组件，所述传感器组件可拆卸地接合于所述助针器的所述进针组件，并且当所述进针组件连同所述传感器组件移动至接近所述接触面的位置时，所述传感器经皮植入患者皮肤下方并且所述传感器组件脱离所述进针组件而被滞留在患者皮肤上；
    独立于所述助针器和所述传感器组件的发射器，当所述传感器组件脱离所述进针组件而被滞留在患者皮肤上后，所述发射器接合所述传感器组件并且电耦接到所述传感器与所述电池，以由所述电池向所述电气组件供电并且由所述电气组件接收并处理所述传感器的检测结果；并且所述发射器向外部发送所述检测结果。
  14. 根据权利要求13所述的医疗系统，其特征在于，所述医疗系统还包括：
    接收器，所述接收器用于接收由所述发射器发送的所述传感器的检测结果。
  15. 一种医疗系统，其特征在于，所述医疗系统包括：
    传感器组件，包括用于经皮检测血糖水平的传感器以及用于安装电池的电池仓；
    具有电气组件的发射器，所述发射器可拆卸地耦接到所述传感器组件，当所述传感器组件被安装在患者皮肤上后，所述发射器能够接合所述传感器组件并电耦接到所述传感器与所述电池，以由所述电池向所述电气组件供电并且由所述电气组件接收并处理所述传感器的检测结果；并且所述发射器向外部发送所述检测结果。
  16. 根据权利要求15所述的医疗系统，其特征在于，所述医疗系统还包括：
    接收器，所述接收器用于接收由所述发射器发送的所述传感器的检测结果。
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