Drug delivery device

Abstract

The application discloses a drug delivery device, which is used for delivering drug or flushing fluid into parotid gland or salivary gland, and comprises: a catheter assembly which comprises a catheter which is arranged to be a hollow structure along the axial direction, the far end of the catheter is provided with an opening, and the catheter is a flexible tube; the mandrel assembly comprises a mandrel which can be movably inserted into the catheter and is higher than the catheter in rigidity, and meanwhile the far end of the mandrel penetrates through the opening to be exposed out of the catheter; wherein the far end of the catheter is provided with a conical tip structure, and the far end of the mandrel is provided with a hemispherical tip structure. The dosing device can easily inject the medicine or the flushing fluid into the parotid gland duct or the salivary gland duct on the premise that the duct wall is prevented from being damaged.

Description

Technical Field

[0001] This application relates to the field of medical technology, and in particular to a drug delivery device. Background Technology

[0002] Current treatments for xerostomia primarily involve injecting medication into the parotid duct using a syringe. However, due to the relatively thick needle and rigid metal material, the syringe is inserted only superficially into the parotid duct, failing to reach the deeper target area. This can lead to reflux of the medication and difficulty in delivering it to the gland, resulting in suboptimal therapeutic effects. Furthermore, the metal needle poses a risk of damaging the parotid duct during insertion, potentially causing inflammation. Therefore, a novel medication delivery device is urgently needed. Summary of the Invention

[0003] This application provides a drug delivery device that can easily inject drugs or flushing solutions into the parotid duct or salivary gland duct without damaging the duct wall.

[0004] The first aspect of this application provides a drug delivery device for delivering a drug or rinsing solution into the parotid gland or salivary gland, comprising: a catheter assembly including a catheter with a hollow structure configured along the axial direction, the distal end of the catheter having an opening, the catheter being a flexible tube; and a mandrel assembly including a mandrel movably inserted into the catheter and having a stiffness greater than that of the catheter, the distal end of the mandrel passing through the opening and exposed outside the catheter; wherein the distal end of the catheter has a tapered tip structure, and the distal end of the mandrel has a hemispherical tip structure.

[0005] The outer circumferential surface of the catheter is provided with a plurality of marking points spaced apart along the axial direction.

[0006] The material of the conduit includes plastic.

[0007] The material of the mandrel includes metal.

[0008] The catheter has imaging capabilities.

[0009] The catheter assembly further includes a catheter seat connected to the proximal end of the catheter, the mandrel being inserted into the catheter via the catheter seat, and the catheter seat having a first Luer connector portion; the mandrel assembly further includes a mandrel cap connected to the proximal end of the mandrel, and the mandrel cap having a second Luer connector portion connected to the first Luer connector portion.

[0010] The Shore hardness range of the catheter is 40D to 70D.

[0011] A second aspect of this application provides a drug delivery device for delivering a drug or rinsing solution into the parotid gland or salivary gland, comprising: a hollow catheter seat; and a catheter including a first catheter segment and a second catheter segment, both hollow, wherein the first catheter segment connects the catheter seat and the second catheter segment, the distal end of the second catheter segment has an opening and a tapered tip structure, and the first catheter segment and the second catheter segment form an obtuse angle, wherein the Shore hardness of the catheter is greater than or equal to 80D.

[0012] The included angle is in the range of 90° to 160°.

[0013] The catheter has imaging capabilities.

[0014] The beneficial effects are: the drug delivery device of this application includes a flexible catheter and a rigid mandrel. The combination of rigidity and flexibility allows for deeper insertion and avoids damage to the parotid duct during insertion. At the same time, the cone-shaped tip structure and hemispherical tip structure can easily break through the parotid papilla, greatly reducing the difficulty of insertion and further reducing damage to the parotid duct by the drug delivery device. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort, wherein: Figure 1 This is a schematic diagram of one embodiment of the drug delivery device of this application; Figure 2 yes Figure 1 Schematic diagram of the middle conduit assembly; Figure 3 yes Figure 1 Schematic diagram of the central spindle assembly; Figure 4 yes Figure 1 A schematic diagram of the cross-sectional structure of the drug delivery device at section line AA; Figure 5 This is a schematic diagram of another embodiment of the drug delivery device of this application; Figure 6 yes Figure 5 A schematic diagram of the cross-sectional structure of the drug delivery device at section line BB. Detailed Implementation

[0016] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0017] It should be noted that the terms "first" and "second" in this application are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or apparatus that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or apparatuses.

[0018] In this application, "distal" and "proximal" are directional terms commonly used in the field of interventional medical devices. "Distal" refers to the end furthest from the operator during the procedure, while "proximal" refers to the end closest to the operator. "Axial" refers to the direction parallel to the line connecting the distal and proximal centers of the medical device; "radial" refers to the direction perpendicular to the aforementioned "axial".

[0019] See Figures 1 to 3 , Figure 1 This is a schematic diagram of one embodiment of the drug delivery device of this application. Figure 2 yes Figure 1 Schematic diagram of the middle conduit assembly. Figure 3 yes Figure 1 A schematic diagram of the mandrel assembly. In one embodiment of this application, the drug delivery device 10 includes a catheter assembly 100 and a mandrel assembly 200.

[0020] First, it should be noted that the drug delivery device 10 of this application can be used to deliver drugs or rinsing solutions into the parotid gland or salivary gland, or it can be used to deliver drugs or rinsing solutions into other sites. This application does not limit this, but for ease of explanation, the following description will focus on the use of the drug delivery device 10 to deliver drugs or rinsing solutions into the parotid gland.

[0021] The conduit assembly 100 includes a conduit 110 with a hollow structure along the axial direction, the distal end of the conduit 110 having an opening, and the conduit 110 being a flexible tube; the mandrel assembly 200 includes a mandrel 210 that is movably inserted into the conduit 110 and has a stiffness greater than that of the conduit 110, with the distal end of the mandrel 210 passing through the opening and exposed outside the conduit 110.

[0022] Specifically, the conduit 110 is a hollow tube with an inner lumen and an opening at its distal end communicating with the inner lumen. The conduit 110 is made of a flexible material, allowing it to bend. The mandrel 210 has a stiffness greater than that of the conduit 110. The mandrel 210 can be inserted into or removed from the conduit 110; that is, the conduit assembly 100 and the mandrel assembly 200 are detachably connected. The mandrel 210 can be configured to match the shape of the insertion site.

[0023] During insertion into the parotid duct, the distal end of the mandrel 210 is exposed outside the catheter 110. Because the mandrel 210 is rigid, it provides sufficient rigidity to the catheter 110 during parotid gland insertion, allowing the drug delivery device 10 to easily penetrate the parotid papilla. After reaching the target position, the mandrel 210 is withdrawn, transforming the drug delivery device 10 from rigid to flexible. This allows the catheter 110 to be easily inserted deeper into the parotid duct, achieving a deeper insertion depth. Subsequently, medication or flushing fluid is injected into the catheter 110 using a syringe, thus achieving drug delivery or internal cleaning of the parotid duct. Throughout this process, the flexible catheter 110 is located outside the mandrel 210, preventing damage to the parotid duct during insertion.

[0024] Meanwhile, the distal end of the catheter 110 is provided with a conical tip structure 111 (it should be noted that, due to the presence of the distal opening of the catheter 110, this conical tip structure 111 is actually a platform tip structure), and the distal end of the mandrel 210 is a closed structure with a hemispherical tip structure 211 (the hemispherical tip structure 211 is a hemispherical or approximately hemispherical structure, which can be understood as the end face of the hemispherical tip structure 211 being an arc surface). That is, the distal ends of both the catheter 110 and the mandrel 210 are rounded. Specifically, the conical tip structure 111 can easily penetrate the parotid papilla and reduce the resistance of the catheter 110 during insertion into the parotid duct, reducing damage to the inner wall of the parotid duct. At the same time, the hemispherical tip structure 211 can also more easily penetrate the parotid papilla, reducing damage to the parotid duct wall.

[0025] As can be seen from the above, the drug delivery device 10 of this application includes a flexible conduit 110 and a rigid spindle 210. The combination of rigidity and flexibility allows for deeper insertion and avoids damage to the parotid duct during insertion. At the same time, the conical tip structure 111 and the hemispherical tip structure 211 can easily penetrate the parotid papilla, greatly reducing the difficulty of insertion and further reducing damage to the parotid duct caused by the drug delivery device 10.

[0026] In one embodiment, the Shore hardness of the catheter 110 is in the range of 40D to 70D. For example, the Shore hardness of the catheter 110 is 40D, 50D, 60D or 70D, etc., and can be selected and set according to actual needs.

[0027] When the mandrel 210 is inserted into the conduit 110, the length of the mandrel 210 exposed outside the conduit 110 through the opening at the distal end of the conduit 110 can be 1mm, 2mm, 3mm, etc., and can be set according to actual needs.

[0028] At the same time, this application does not limit the taper of the tapered tip structure 111. For example, the taper range of the tapered tip structure 111 can be from 1:1 to 1:10.

[0029] In one embodiment, to reduce the difficulty of removing the mandrel 210 from the conduit 110, when the mandrel 210 is inserted into the conduit 110, a gap is provided between the outer peripheral wall of the mandrel 210 and the inner peripheral wall of the conduit 110, that is, the outer diameter of the mandrel 210 is smaller than the inner diameter of the conduit 110, specifically as follows: Figure 4 As shown, where Figure 4 yes Figure 1 A schematic diagram of the cross-sectional structure of the drug delivery device at section line AA.

[0030] In one embodiment, the hardness ratio of the mandrel 210 to the guide tube 110 can be 1.5, 2, 2.5, 5, etc., and there is no specific limitation.

[0031] The mandrel 210 can be a hollow tube or a solid tube; this application does not impose any restrictions.

[0032] See Figure 1 as well as Figure 2In one embodiment, the outer peripheral surface of the catheter 110 is provided with a plurality of marking points 112 spaced apart axially. Specifically, the arrangement of the plurality of marking points 112 facilitates observation of the insertion depth of the drug delivery device 10 during insertion. The marking points 112 can be implemented by laser marking, ink printing, or other methods; this application does not limit the form or method. The number of marking points 112 can be three, four, or even more; this application does not limit the number. The plurality of marking points 112 can be arranged at equal intervals or unequal intervals. Of course, in other embodiments, marking points 112 may not be provided on the outer peripheral surface of the catheter 110.

[0033] In another embodiment, the outer peripheral surface of the catheter 110 is provided with a measuring scale to better observe the insertion depth of the drug delivery device 10.

[0034] In one embodiment, the material of the conduit 110 includes plastic. Plastic is a common, low-cost, and readily available flexible material; therefore, including plastic in the material of the conduit 110 can reduce costs and ensure that the conduit 110 is a flexible tube.

[0035] The material of catheter 110 includes at least one of polyamide (PA) and polyether block polyamide (Pebax). Specifically, the material of catheter 110 can be polyamide (PA), polyether block polyamide (Pebax), or a mixture of polyamide (PA) and polyether block polyamide (Pebax).

[0036] In other embodiments, the material of the catheter 110 may also be polytetrafluoroethylene, polyethylene terephthalate, perfluoroethylene propylene, high-density polyethylene, or low-density polyethylene, or the material of the catheter 110 may also be a biocompatible material. In summary, this application does not impose specific limitations on the material of the catheter 110, as long as the catheter 110 can be a flexible tube.

[0037] In one embodiment, the mandrel 210 is made of metal. Metal is a common rigid material, so making the mandrel 210 of metal can reduce costs while ensuring the rigidity of the mandrel 210.

[0038] The material of the mandrel 210 includes at least one of nickel-titanium alloy and stainless steel. For example, the material of the mandrel 210 is nickel-titanium alloy, or the material of the mandrel 210 is stainless steel, or the material of the mandrel 210 is titanium.

[0039] In another embodiment, the mandrel 210 is made of a medical-grade polymer material, such as polypropylene, polytetrafluoroethylene, polycarbonate, polyvinyl chloride, polyethylene, polystyrene, or polyetheretherketone. In summary, this application does not limit the material of the mandrel 210, as long as the stiffness of the mandrel 210 is greater than that of the catheter 110.

[0040] In one embodiment, the outer surface of the mandrel 210 may be coated with a lubricating coating to reduce the surface friction of the mandrel 210, thereby facilitating the insertion of the mandrel 210 into the conduit 110 or facilitating the extraction of the mandrel 210 from the conduit 110.

[0041] The lubricating coating can be applied to the entire outer surface of the mandrel 210, or to the outer surface of the distal portion of the mandrel 210, which is no more than 3 / 4 of the total length of the mandrel 210.

[0042] In one embodiment, the lubricating coating may be a polytetrafluoroethylene coating, a pyrrolidone coating, or a polyvinylpyrrolidone coating. The lubricating coating can also be formed on the outer surface of the mandrel 210 using processes such as spraying, dip coating, or vacuum deposition.

[0043] In one embodiment, the catheter 110 has an imaging function. Specifically, the catheter 110 has an X-ray imaging function, which allows the operator to easily observe the position of the catheter 110 in the parotid duct during surgery, reducing the difficulty of the operation and avoiding damage to the parotid duct. Of course, in other embodiments, the catheter 110 may not have an imaging function.

[0044] In one embodiment, the catheter 110 is doped with a radiopaque material, that is, the radiopaque material is dispersed in the host material during the preparation process, and then the catheter 110 is made.

[0045] In another embodiment, the catheter 110 is provided with a contrast-enhancing ring. The contrast-enhancing ring can be embedded in the wall of the catheter 110. In this case, during insertion, the contrast-enhancing ring will not directly contact human tissue, will not damage human tissue, and will not release heavy metal ions that could harm human tissue, thus posing no risk of sensitization. Specifically, the contrast-enhancing ring may be located at the distal end of the catheter 110. Furthermore, the number of contrast-enhancing rings can be one or multiple.

[0046] Continue reading Figure 1 , Figure 2 as well as Figure 3 The catheter assembly 100 also includes a catheter seat 120 connected to the proximal end of the catheter 110, and the mandrel 210 is inserted into the catheter 110 through the catheter seat 120. The catheter seat 120 is provided with a first Luer connector 121. The mandrel assembly 200 also includes a mandrel cap 220 connected to the proximal end of the mandrel 210. The mandrel cap 220 is provided with a second Luer connector 221 connected to the first Luer connector 121.

[0047] Specifically, one of the first Luer connector 121 and the second Luer connector 221 is a male Luer connector and the other is a female Luer connector, so that the catheter assembly 100 and the mandrel assembly 200 are connected through the Luer connector. The Luer connector is a standardized micro-leakage-free connector that is now widely used in the medical field.

[0048] The aforementioned Luer connector design can prevent loosening between the catheter assembly 100 and the spindle assembly 200 during insertion, thereby ensuring the stability of the drug delivery device 10 during insertion into the parotid duct. Furthermore, since the Luer connector is a mature structure, it can also reduce manufacturing costs.

[0049] Meanwhile, after the spindle assembly 200 is separated from the catheter assembly 100, the catheter seat 120 can also be connected to the syringe through the first Luer connector 121, thereby ensuring the stability of the syringe when injecting drugs or flushing fluid into the catheter seat 120 and avoiding leakage of drugs or flushing fluid.

[0050] Of course, in other embodiments, the conduit seat 120 and the mandrel cap 220 can also be connected in other ways, such as by threaded connection. Furthermore, this application does not limit the materials of the conduit seat 120 and the mandrel cap 220; they can be made of the same or different materials. For example, both the conduit seat 120 and the mandrel cap 220 can be made of plastic.

[0051] In one embodiment, the conduit 110 and the conduit seat 120 are bonded together to ensure the connection strength. In other embodiments, the conduit 110 and the conduit seat 120 may also be connected by means of snap-fit ​​or other methods, or the conduit 110 and the conduit seat 120 may be integrally formed. This application does not limit the connection method between the conduit 110 and the conduit seat 120.

[0052] In one embodiment, the mandrel 210 and the mandrel cap 220 are bonded together to ensure the connection strength. In other embodiments, the mandrel 210 and the mandrel cap 220 may also be connected by snap-fit ​​or other means, or the mandrel 210 and the mandrel cap 220 may be integrally formed. This application does not limit the connection method between the mandrel 210 and the mandrel cap 220.

[0053] As can be seen from the above, this application employs a rigid-flexible design that allows for deeper insertion while preventing damage to the parotid duct during insertion. Simultaneously, the conical tip structure 111 and hemispherical tip structure 211 easily penetrate the parotid papilla, significantly reducing insertion difficulty and further minimizing damage to the parotid duct caused by the drug delivery device 10. Furthermore, multiple marker points 112 on the periphery of the catheter 110 facilitate measurement of its insertion depth, simplifying operation. Moreover, the drug delivery device 10 of this application can be used for drug infusion and internal irrigation of the parotid and salivary gland ducts, offering a wide range of applications, meeting diverse needs, and achieving excellent therapeutic effects.

[0054] See Figure 5 as well as Figure 6 Another embodiment of this application also provides a drug delivery device 30, which has the same function as the drug delivery device 10 described above. Both can be used to deliver drugs or rinsing solutions into the parotid gland or salivary gland, or to deliver drugs or rinsing solutions into other sites. For ease of explanation, the following description will focus on the use of the drug delivery device 30 to deliver drugs or rinsing solutions into the parotid gland. Figure 5 In this embodiment, the drug delivery device 30 includes a catheter seat 310 and a catheter 320.

[0055] The catheter seat 310 is hollow; the catheter 320 includes a first catheter segment 321 and a second catheter segment 322, both of which are hollow. The first catheter segment 321 connects the catheter seat 310 and the second catheter segment 322. The distal end of the second catheter segment 322 has an opening and a tapered tip structure 301. The first catheter segment 321 and the second catheter segment 322 form an angle θ, which is an obtuse angle. The Shore hardness of the catheter 320 is greater than or equal to 80D.

[0056] Specifically, the Shore A hardness of catheter 320 is set to be greater than or equal to 80D, giving it a certain degree of rigidity. During insertion into the parotid duct, catheter 320 can easily penetrate the parotid papilla, allowing for deeper insertion. Subsequently, medication or flushing fluid is injected into catheter 320 using a syringe, thereby achieving drug delivery or internal cleaning of the parotid duct. The Shore A hardness of catheter 320 can be 80D, 90D, or 100D, etc., and can be set according to actual needs.

[0057] Meanwhile, the angle θ formed between the first catheter segment 321 and the second catheter segment 322 is an obtuse angle, which allows the catheter 320 to conform to the anatomical structure of the parotid duct or salivary duct, reducing the damage to the parotid duct or salivary duct caused by the catheter 320 during insertion.

[0058] Meanwhile, the distal end of the second duct segment 322 is provided with a conical tip structure 301 (it should be noted that, due to the presence of the distal opening of the second duct segment 322, the conical tip structure 301 is actually a platform tip structure), meaning that the distal end of the second duct segment 322 is rounded. The conical tip structure 301 can easily penetrate the parotid papilla and reduce the resistance of the duct 320 during insertion into the parotid duct, thus reducing damage to the inner wall of the parotid duct.

[0059] In one embodiment, the conical tip structure 301 is the same as the conical tip structure 111 described above, and the details can be found in the relevant content above, which will not be repeated here.

[0060] In one embodiment, the first catheter segment 321 and the second catheter segment 322 are integrally formed to ensure the strength of the catheter 320. During the manufacturing process, a heat setting process can be used to form an angle θ between the first catheter segment 321 and the second catheter segment 322.

[0061] In one embodiment, the material of the catheter 320 includes plastics, such as at least one of polyamide (PA) and polyether block polyamide (Pebax).

[0062] In one embodiment, the catheter seat 310 is provided with a Luer connector for connecting to a syringe, which can ensure the stability of the syringe when injecting drugs or flushing fluid into the catheter seat 310 and prevent leakage of drugs or flushing fluid.

[0063] In one embodiment, the catheter seat 310 has the same structure as the catheter seat 120 described above, as detailed in the relevant content above, and will not be repeated here.

[0064] In one embodiment, the included angle θ ranges from 90° to 160°, for example, θ is 90°, 100°, 120°, 140°, 150°, or 160°. This angle range allows the catheter 320 to better conform to the anatomical structure of the parotid duct or salivary duct, further reducing damage to the parotid duct or salivary duct caused by the catheter 320 during insertion.

[0065] In one embodiment, similar to the catheter 110 described above, the catheter 320 has a radiopaque function, that is, the catheter 310 has X-ray radiopaque capability, which allows the operator to easily observe the position of the catheter 310 in the parotid duct during surgery, reducing the difficulty of the operation and avoiding damage to the parotid duct. Similar to the catheter 110, the catheter 310 may contain radiopaque material or have a radiopaque ring on it, as detailed above, and will not be repeated here.

[0066] Continue reading Figure 5Preferably, the length of the first catheter segment 321 is greater than the length of the second catheter segment 322 to achieve better insertion.

[0067] The catheter seat 310 and the catheter 320 can be connected by bonding or integral molding, and there is no restriction on this.

[0068] In one embodiment, similar to the catheter 110 described above, the outer peripheral surface of the catheter 320 may also be provided with a plurality of axially spaced marker points 112, which facilitates observation of the insertion depth of the drug delivery device 30 during insertion. Details regarding the marker points 112 can be found in the aforementioned related content and will not be repeated here.

[0069] The above description is merely an embodiment of this application and does not limit the patent scope of this application. Any equivalent structural or procedural transformations made using the content of this application's specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of this application.

Claims

1. A drug delivery device, characterized in that, Used to deliver medication or flushing solution into the parotid or salivary glands, including: A conduit assembly includes a conduit configured as a hollow structure along the axial direction, wherein the distal end of the conduit has an opening, and the conduit is a flexible tube; A mandrel assembly includes a mandrel that is movably inserted into the catheter and has a stiffness greater than that of the catheter, with the distal end of the mandrel exposed outside the catheter through the opening; The distal end of the catheter is provided with a tapered tip structure, and the distal end of the mandrel is provided with a hemispherical tip structure.

2. The drug delivery device according to claim 1, characterized in that, The outer circumferential surface of the conduit is provided with multiple marking points spaced apart along the axial direction.

3. The drug delivery device according to claim 1, characterized in that, The material of the conduit includes plastic.

4. The drug delivery device according to claim 1, characterized in that, The mandrel is made of metal.

5. The drug delivery device according to claim 1, characterized in that, The catheter has imaging capabilities.

6. The drug delivery device according to claim 1, characterized in that, The catheter assembly further includes a catheter seat connected to the proximal end of the catheter, the mandrel being inserted into the catheter via the catheter seat, and the catheter seat having a first Luer connector portion; The mandrel assembly also includes a mandrel cap connected to the proximal end of the mandrel, and the mandrel cap is provided with a second Luer connector that connects to the first Luer connector.

7. The drug delivery device according to claim 1, characterized in that, The Shore hardness range of the catheter is 40D~70D.

8. A drug delivery device, characterized in that, Used to deliver medication or flushing solution into the parotid or salivary glands, including: The catheter hub is hollow. The catheter includes a first catheter segment and a second catheter segment, both of which are hollow. The first catheter segment connects the catheter seat and the second catheter segment. The distal end of the second catheter segment has an opening and a tapered tip structure. The first catheter segment and the second catheter segment form an angle, which is an obtuse angle. The Shore hardness of the catheter is greater than or equal to 80D.

9. The drug delivery device according to claim 8, characterized in that, The included angle ranges from 90° to 160°.

10. The drug delivery device according to claim 8, characterized in that, The catheter has imaging capabilities.

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