A medical device seal protection device

Abstract

The application discloses a kind of medical equipment sealing protection device, comprising: medical equipment shell, two ends are equipped with first opening and second opening;Sensor implantation needle passes through two openings, first end portion is sealed with first opening, and second end portion is connected with protective cap.Second end portion is equipped with non-circumferential groove with open end;Protective cap is correspondingly provided with non-circumferential fixing rib, and the first end thereof is axial downward end face.When the protective cap is rotated and assembled, the two inclined surfaces cooperate with each other to convert the rotary motion into axial motion, forming a sealing pressure.The design realizes the accurate axial displacement of the protective cap during rotation and installation through mechanical structure optimization, ensuring the efficient sealing and stable connection of the sensor implantation needle, and is suitable for medical implant components that require long-term stable protection.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a device for sealing and protecting sensor implantation needles. Background Technology

[0002] In the field of medical devices, especially in blood glucose monitoring, sensor implantation needles are used to insert sensors into the human body to detect relevant parameters in real time. In such devices, it is often necessary to protect and seal the sensor implantation needles before use to prevent contamination of the needle and sensor from the external environment, and to avoid accidental contact or damage during operation.

[0003] Currently, common sensor implantation needle protection methods can be broadly categorized as follows:

[0004] 1. Simple friction fit type: This type of seal is achieved by setting an annular flange or inner wall protrusion at the end of the implantation needle, which presses against the inner wall of the protective cap. However, this type of structure is prone to detachment or poor sealing in actual use, and the accuracy during repeated assembly is low.

[0005] 2. Snap-on or threaded engagement type: The protective cap is tightened or locked onto the end of the implantation needle using a snap-on or threaded mechanism. While this can improve assembly stability to some extent, it is easily affected by machining accuracy or usage conditions, leading to jamming or incomplete sealing.

[0006] 3. Lack of axial preload and positioning: Many existing devices cannot form controllable axial displacement and locking during rotation operation, which may cause the protective cap to loosen or even fall off during use.

[0007] Based on the aforementioned limitations of existing technologies, there is a need for a medical device sealing and protection device that features reliable sealing, controllable axial assembly in its structural design, and ease of operation, in order to effectively improve the protection of sensor implantation needles and enhance their safety. Summary of the Invention

[0008] This invention relates to a sealing and protective device for medical devices, designed to provide reliable sealing and protection for sensor implantation needles while improving assembly stability and ease of use. The sealing and protective device of this invention, through a special structural design, achieves axial pre-tightening during rotational operation, and possesses excellent sealing performance and anti-dislodgement properties. It is suitable for protecting various implantable sensor needles, including blood glucose sensors.

[0009] According to one embodiment of the present invention, the medical device sealing protection device includes:

[0010] The medical device housing has a first opening and a second opening on its first and second surfaces, respectively, forming a channel through which a sensor implantation needle can pass.

[0011] The sensor implantation needle passes through a first opening and a second opening of the housing and includes the following parts: a first end, which seals with the first opening to prevent external environment from contaminating the needle body or the sensor; a second end, which is used to connect with a protective cap; and a non-circular groove is provided on the second end, which includes an open end and a closed end, and has an axial end face at the open end, so that the rotational movement can be converted into axial pre-tightening when it is subsequently assembled with the protective cap.

[0012] The protective cap is connected to the second end of the sensor implantation needle and has a non-circular fixing rib on its own structure that mates with the non-circular groove. The first end of the fixing rib has an axially descending end face. When it mates with the axial end face of the second end, it can convert the rotational motion vector of the protective cap into an axial displacement of the protective cap, thereby achieving a good sealing and fixing effect.

[0013] During assembly, by rotating the protective cap, the axially descending end face of the non-circular fixing rib interacts with the axially ascending end face of the non-circular groove, causing the protective cap to move along the axial direction of the sensor implantation needle and generate pre-tightening, making the overall seal more reliable.

[0014] In one specific embodiment, to prevent damage or loosening of the non-circular fixing rib due to excessive movement during rotation, a stop portion is provided at the end of the non-circular groove away from the opening end to limit the maximum radial rotation angle of the non-circular fixing rib, thereby further improving the accuracy and safety of the assembly process.

[0015] In one specific embodiment, the second end can be designed to have a non-circular planar projection, and the corresponding assembly opening inside the protective cap also has the same or similar non-circular projection. The overlap in shape ensures precise alignment during assembly, avoiding the rotational slippage inherent in ordinary circular structures.

[0016] In one specific embodiment, the non-circular fixing rib can be positioned on the opposite side of the assembly opening to further optimize the fitting space, making it easier for the protective cap to be positioned with the second end during rotational assembly.

[0017] In one specific embodiment, a protruding frustum structure may be provided near the end cap surface of the protective cap, and non-circular fixing ribs and assembly openings are arranged on the frustum; the frustum may also be provided with a sealing gasket to enhance the seal between the second end and the protective cap and prevent external gas or liquid from seeping in.

[0018] In one specific embodiment, the protective cap can be used to encapsulate a medical-grade gas to provide an inert environment or sterile protection for the implanted needle or sensor during specific operations, thereby further improving the safety of medical procedures.

[0019] In one specific embodiment, to ensure that the non-circular groove and the non-circular fixing rib are matched, their distribution arcs a and b satisfy a + b = π (180°). Through this specific arc design, sufficient axial lifting stroke can be obtained within a limited rotation range, achieving more reliable fastening.

[0020] In one specific embodiment, the structure described in this invention is particularly suitable for implantation needles of blood glucose sensors, and can significantly improve the protection and sealing effect of the blood glucose sensor needle body. However, it is not limited to blood glucose monitoring and can also be adapted to other implantable medical sensors.

[0021] In one specific embodiment, the protective cap may further include a removable sealing bottom component to facilitate opening or replacing the sealing space under the protective cap when needed, thereby enhancing the flexibility of the device in use and maintenance.

[0022] The present invention has the following superior technical effects compared to the prior art:

[0023] 1. Excellent sealing performance: By utilizing the axial fit between the non-circular groove and the non-circular fixed rib, axial movement can be obtained and controlled through rotation, forming an axial clamping force to provide a sealing effect.

[0024] 2. The assembly operation is simple. Relying on the guidance of the non-circular structure, the user only needs to rotate within a relatively limited angle to complete the assembly and obtain pre-tightening, which greatly reduces the dependence on the operation precision.

[0025] 3. Enhanced anti-drop capability: The combination of axial pre-tightening and stop design prevents the protective cap from accidentally loosening or falling off during use or transportation, improving the safety of medical operations and the reliability of needle protection.

[0026] In summary, this invention, by setting non-circular grooves and non-circular fixing ribs on the second end of the sensor implantation needle and the protective cap respectively, and by utilizing the interlocking axial rising and axial falling end faces to realize the conversion of rotational motion into axial displacement during the mating process, not only enhances the sealing effect and protective performance, but also has the advantages of easy operation and high versatility, and has significant technical progress and practical value. Attached Figure Description

[0027] Figure 1 This is a cross-sectional view of the assembled sealing and protection device for this medical equipment.

[0028] Figure 2This is an exploded view of the protective cap and the tip of the sensor implantation needle.

[0029] Figure 3 This is a three-dimensional schematic diagram of the assembly of the protective cap and the sensor implantation needle.

[0030] Figure 4 This is a three-dimensional schematic diagram from another perspective of the assembly of the protective cap and the sensor implantation needle.

[0031] Figure 5 This is a magnified schematic diagram of the interlocking parts of the non-circular fixed ribs.

[0032] Figure 6 This is a schematic diagram showing the protective cap and the sensor implantation needle tip mated together, viewed from the top. Detailed Implementation

[0033] The following will be combined with the appendix Figures 1 to 6 The preferred embodiments of the present invention are described in detail. It should be particularly noted that these specific embodiments are intended to more clearly reveal the core technical solution of the present invention through illustrative examples and do not constitute a limitation on the scope of protection of the claims. Within the technical framework defined by the claims of the present invention, those skilled in the art can make equivalent modifications or adaptive adjustments to the structural forms in the embodiments. The term "non-circumferential" as used in this specification specifically refers to technical features with a circular cross-sectional profile distributed circumferentially, whose projected profile conforms to circular geometric features but does not cover the entire circumference, and whose actual distribution range occupies a specific central angle interval (θ < 360°).

[0034] like Figure 1 As shown, the medical device sealing and protection device of this application is part of a continuous glucose analyzer 100, which is installed at the bottom of an implantation tool 400 as part of the implantation tool 400 before implantation. The implantation tool 400 includes an outer housing 410 and a trigger button 420 on the housing 410; the housing 410 contains a first spring 430 and a second spring 440. The first spring 430 drives the medical device sealing and protection device to move downward. When the medical device moves onto the skin, the medical double-sided adhesive on its lower surface adheres to the skin, thereby fixing it to the skin surface. Subsequently, the second spring 440 is automatically triggered to pull out the needle.

[0035] Before the implantation process described above, the protective cap 300 in front of the implantation needle needs to be manually removed. This cap 300 contains a medical-grade gas used to isolate the external environment, prevent contamination, or for sterilization. This medical-grade gas includes nitrogen (N2), argon (Ar), or carbon dioxide, as well as gases commonly used by those skilled in the art, such as ethylene oxide and ozone. After removal, the gas dissipates, and implantation can then proceed. The protective cap 300 internally encapsulates the medical-grade gas to maintain a localized sterile or inert environment. This feature offers significant advantages for sensors with high cleanliness requirements, such as blood glucose sensors.

[0036] After implantation, the implantation tool 400 and the continuous glucose analyzer 100 are separated. In addition to the aforementioned implantation tool 400, those skilled in the art may choose other equivalent implantation tools, which will not be described in detail here.

[0037] This embodiment uses a continuous glucose analyzer as an example to illustrate the medical device, but those skilled in the art will realize that it can also be applied to other medical devices.

[0038] Continue to refer to Figure 1 and Figure 2 As shown, a first opening 110 is provided on the first surface of the housing 101 of the continuous glucose analyzer, and a second opening 120 is provided on the second surface; the first opening 110 and the second opening 120 are respectively located on opposite sides of the housing 101. The openings communicate with the internal space of the medical device, allowing the sensor implantation needle 200 to pass through the first opening 110 and the second opening 120. The sensor implantation needle 200 passes through the second opening 120 and extends partially beyond the second opening 120, with the portion exceeding the second opening 120 being received by the protective cap 300. When inserted, the first end 210 of the sensor implantation needle 200 fits tightly with the periphery of the first opening 110, forming a preliminary seal to prevent external environmental contamination of the needle body and the sensor.

[0039] The flexible sensor 201 described in this embodiment is used to sense blood glucose signals. It is inserted into the sensor implantation needle 200 before implantation. This needle is flexible and typically made of a flexible substrate material (such as polyimide or PDMS). The implantation depth is only 4-5 mm, significantly reducing puncture pain (puncture force less than 1N). Its functional layer consists of an electrode layer, an enzyme layer, and an outer membrane. The electrode layer uses conductive materials such as carbon nanotubes and silver nanowires to achieve efficient electron transfer. The enzyme layer uses glucose oxidase as the core to catalyze the glucose oxidation reaction. The outer membrane is a selectively permeable membrane to balance the glucose mass transfer rate and anti-interference capability. In terms of working principle, this flexible sensor is based on an electrochemical reaction. When glucose is oxidized to gluconic acid and hydrogen peroxide under the catalysis of glucose oxidase, the glucose concentration can be calculated by detecting changes in oxidation current or oxygen content.

[0040] Reference Figure 2 and Figure 3 As shown, in order to more clearly illustrate the assembly relationship, Figure 3 The portion of the medical device housing 101 is omitted; only the exploded structural diagram of the sensor implantation needle 200 and the protective cap 300 is shown.

[0041] Furthermore, the sensor implantation needle 200 includes a first end 210 and a second end 220, wherein the first end 210 is sealed to the first opening 110; a first sealing gasket 330 is provided at the connection between the first end 210 and the first opening 110, and the first sealing gasket 330 is compressed by the first end 210 when the protective cap 300 is installed on the sensor implantation needle 200, thereby sealing the connection interface between the first opening 110 and the second end 220.

[0042] The second end 220 can be connected to the protective cap 300; the first end 210 is disposed on the first frustum base 211, and a semi-cylinder 212 is disposed on the first frustum base 211, the end face of which is the second end 220.

[0043] Furthermore, the non-circular cylinder 212 is a semi-cylinder.

[0044] Furthermore, a non-circular groove 230 is provided on the second end 220. The non-circular groove 230 includes an open end 231 and a closed end 232, and the open end 231 is provided with an end face along the axial direction.

[0045] The bottom of the non-circular groove 230 includes an edge 233 that extends around the non-circular column 212 but does not completely cover the semi-circle; a certain notch 235 is reserved at the opening end, which is used to guide the non-circular fixing rib 310 on the protective cap 300 into the notch 235 when the protective cap 300 is assembled.

[0046] Furthermore, its open end has an end face 236 that rises obliquely along the axis, which cooperates with the non-circular fixing rib 310 on the protective cap 300. This design can not only realize the conversion of rotational axial movement, but the obliquely rising end face 236 can also be a plane, a spiral surface, or a convex or concave surface.

[0047] Furthermore, such as Figure 4 As shown, a stop portion 234 may be provided on the side of the non-circular groove 230 away from the opening end to limit the maximum radial rotation angle of the non-circular fixing rib 310. This stop portion 234 can prevent damage caused by excessive rotation or assembly errors.

[0048] like Figure 4As shown, to clearly illustrate the assembly relationship, a partial section of the protective cap 300 is provided. The protective cap 300 has a generally cylindrical structure, with its top abutting against the sensor implantation needle 200. A frustum structure 320 is arranged on the protective cap 300, and a non-circular fixing rib 310 is included on the radially inner side of the frustum structure 320 for engaging with the non-circular groove 230 of the sensor implantation needle 200. The non-circular fixing rib 310 connects to the second end 220 of the sensor implantation needle 200, and its first end has an axially descending end face 311 (e.g., ...). Figure 5 (As shown). When the protective cap 300 is assembled with the second end 220, the axially descending end face 311 of the non-circular fixing rib 310 and the axially descending end face of the non-circular groove 230 cooperate with each other, realizing the conversion of the rotational movement of the protective cap 300 to the axial direction, thereby effectively locking and sealing the sensor implant needle 200. Due to the axial movement generated by its rotation, the first sealing gasket 330 and the second sealing gasket 331 described below are completely clamped by the first end 210 and the second end 220, so that the opening is sealed.

[0049] Furthermore, such as Figure 2 As shown, the bottom of the protective cap 300 has a certain height to form a closed space, or optionally a detachable sealing bottom component 340 is provided. A second sealing gasket 331 is provided between the frustum structure 320 and the second end 220 to enhance the sealing performance. When the protective cap 300 rotates around its axis, the second sealing gasket 331 is pressed tightly against the second end 220 and the surface of the protective cap 300 under the action of axial preload, so that the protective cap 300 and the sensor implantation needle 200 form a sealed space.

[0050] Furthermore, the frustum structure 320 protrudes from the surface of the protective cap 300. A non-circular fixing rib 310 and an assembly opening 312 are arranged on the frustum structure 320. The non-circular fixing rib is located on the opposite side of the assembly opening 312. In this embodiment, the distribution range of the arc occupied by the non-circular fixing rib 310 and the assembly opening 312 is π / 2.

[0051] Furthermore, such as Figure 4 and Figure 5 As shown, the first end of the non-circular fixing rib 310 has an axially descending end face 311 that engages with the axially ascending end face 236 of the opening end of the non-circular groove 230. When the user rotates the protective cap 300, the non-circular fixing rib 310, guided by the non-circular groove 230, drives the protective cap 300 to move axially along the sensor implant needle 200, thereby pressing the sealing component around the second end 220 to achieve an effective seal.

[0052] Furthermore, the term "axial" specifically refers to Figure 4The directions indicated by the X-axis, "up" and "down" are based on Figure 4 The orientation relationships are defined by the coordinate system shown on the paper. Those skilled in the art should understand that the directions described in the specification are technical definitions of spatial relative relationships, and even if all directional reference systems are rotated as a whole, the technical solution should still be considered equivalent to the directional definitions of this application.

[0053] Furthermore, such as Figure 3 and Figure 6 As shown, inside the frustum structure 320, the non-circular fixing rib 310 has a non-circular opening 312 opposite to it. The non-circular opening 312 is used to receive the needle body when the second end 220 is assembled with the protective cap 300, so that the portion of the non-circular groove 230 axially downward can be inserted into the protective cap 300 and retained in the protective cap 300 after rotation.

[0054] Furthermore, the distribution arc of the non-circular opening 312 is c, and the distribution arc of the non-circular fixed rib 310 is a, and the two satisfy the relationship c+a=π.

[0055] Furthermore, the distribution curvature of the non-circular groove 230 and the non-circular fixed rib 310 can be set according to specific requirements. If the curvatures of the two are a and b, satisfying a+b=π(180°), a large axial movement can be achieved within a relatively small rotation angle range.

[0056] Furthermore, the non-circular opening 312 and the non-circular cylinder 212 have the same planar projection shape, and the radian a is equal to the radian c.

[0057] Furthermore, the first opening 110 and the second opening 120 have the same projection as the non-circular opening, so that the non-circular cylinder can enter the first opening 110 and the second opening 120, which are also non-circular openings. Figure 6 As shown, the assembly structure of the protective cap 300 and the sensor implantation needle 200 also presents corresponding non-circular projections when viewed from above, ensuring that the two are correctly aligned and fully engaged.

[0058] Furthermore, the "distribution radian" refers to the central angle formed by the line connecting the two outermost points of the projected outline of the non-circular opening structure to the center of the reference circle when the non-circular opening structure is projected onto the reference circle.

[0059] The assembly process is described below:

[0060] First, prepare the medical device, which has a complete medical device housing 101, a first opening 110, and a second opening 120. The sensor implantation needle 200 is inserted into the first sealing gasket 330, and then the sensor implantation needle 200 with the first sealing gasket 330 is inserted into the first opening 110 and the second opening 120 of the housing 101, and the first end 210 is sealed to form an assembly.

[0061] The assembled unit is placed into the implantation tool 400 and connected to the medical device housing of the implantation tool 400.

[0062] Assemble the protective cap 300, check the relative positions of the non-circular groove 230 and the non-circular fixing rib 310 on the protective cap 300, and confirm that the positions are aligned. Insert the protective cap 300 onto the second end 220 along the corresponding assembly direction, and rotate it slightly clockwise or counterclockwise as follows. Figure 6 The direction indicated by the arrow (stp1 indicates the status);

[0063] During rotation, the non-circular fixing rib 310 slides along the groove wall, and its descending end face 311 interacts with the rising end face 236 of the non-circular groove 230, causing the protective cap 300 to gradually rise along the needle axis (X-axis), squeezing the first sealing gasket 330 and the second sealing gasket 331; when the non-circular fixing rib 310 reaches the stop part 231 and can no longer rotate, it indicates that the positioning is completed (stp2 indicator state), and the protective cap 300 is reliably locked and provides an effective seal.

[0064] The above operation can be performed in an environment filled with a special gas, so that the protective cap 300 is filled with this gas after assembly. For example, the above operation can be performed in a glove box filled with sterile inert gas.

[0065] After this assembly is completed, the sensor implant needle 200 can be used for the expected medical or implantation procedures along with the housing 101. If it is necessary to replace the protective cap 300 or inspect the sensor implant needle 200, simply rotate the protective cap 300 in the reverse direction to retract the non-circular fixing rib 310 to the open end position, and the protective cap 300 can be removed.

[0066] As can be seen from the above specific embodiments, the present invention effectively solves the technical problems of traditional implantation needle protective caps being easy to fall off, not sealing properly, and being troublesome to assemble.

[0067] The protective cap 300 and the sensor implantation needle 200 achieve rotation-axial conversion through non-circular engagement, which can quickly and stably complete the sealing. The sealing performance is further improved by the first sealing gasket 330 and the second sealing gasket 331.

[0068] The overall structure allows medical staff or users to perform only a few rotational movements during assembly and disassembly, saving effort and time and reducing operational risks.

[0069] The stop part 231 and the axial preload design ensure that the protective cap 300 is not easy to loosen during normal use, thereby improving safety and service life.

[0070] By encapsulating medical-grade gas inside the protective cap 300 or using a removable sealed bottom component 340, it can adapt to various sensor types and medical scenarios, offering high flexibility.

[0071] The above combination Figures 1 to 6 The specific embodiments are described in detail in the claims of this invention. Those skilled in the art, after understanding the above principles, can make appropriate modifications or equivalent substitutions to the specific structure or materials of the device; however, any modifications or substitutions that do not depart from the basic spirit of this invention should be considered to fall within the protection scope of this invention.

Claims

1. A sealing and protective device for medical equipment, characterized in that, include: The medical device housing has a first opening and a second opening respectively on its first and second surfaces; A sensor implantation needle passes through the first opening and the second opening, the sensor implantation needle comprising: The first end is sealed to fit the first opening; The second end is used to connect the protective cap; a non-circular groove is provided on the second end, the non-circular groove including an open end and a closed end, the open end having an end face that rises axially; A protective cap is connected to the second end of the sensor implantation needle; the protective cap is provided with a non-circular fixing rib, the first end of which has an end face that descends axially; When the protective cap is assembled with the second end, the axially descending end face and the axially rising end face cooperate with each other, thereby converting the rotational motion of the protective cap into the axial motion of the protective cap.

2. The medical device sealing and protection device according to claim 1, characterized in that, The non-circular groove includes a stop portion at the other end away from the opening end, which is used to limit the maximum rotation angle of the non-circular fixing rib.

3. The medical device sealing and protection device according to claim 2, characterized in that, The second end has a non-circular projection, and the end of the protective cap connected to the second end is provided with an assembly opening, which also has a non-circular projection with the same shape as the non-circular projection.

4. The medical device sealing and protection device according to claim 3, characterized in that, The non-circular fixing rib is located on the opposite side of the assembly opening.

5. The medical device sealing and protection device according to claim 4, characterized in that, The non-circular fixing rib and the assembly opening are set on the protruding circular platform on the surface.

6. The medical device sealing and protection device according to claim 5, characterized in that, A sealing gasket is provided on the circular platform, and the sealing gasket is used to seal the second end and the protective cap.

7. The medical device sealing and protection device according to any one of claims 1-6, characterized in that, The protective cap is encapsulated with a special medical gas.

8. The medical device sealing and protection device according to any one of claims 1-6, characterized in that, The distribution arc of the non-circular groove is a, and the distribution arc of the non-circular fixed rib is b, and the relationship a+b=π is satisfied.

9. The medical device sealing and protection device according to any one of claims 1-6, characterized in that, The sensor implanted needle includes a blood glucose sensor.

10. The medical device sealing and protection device according to any one of claims 1-6, characterized in that, The protective cap includes a removable sealed bottom component.

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