Pneumatic implanting device and system for implant

Abstract

The invention provides a pneumatic implanting device and system for an implant. The pneumatic implanting device and system are used for implanting the implant into a lacrimal passage or subcutaneous tissues. The pneumatic implantation device comprises a movable assembly and a catheter. The movable assembly comprises a syringe and a piston part, an air cavity located in the syringe is formed between the piston part and the far end of the syringe, the piston part at least has a first position and a second position in the syringe, and the piston part at the first position is close to the far end of the syringe relative to the piston part at the second position. The catheter is provided with a containing cavity used for containing an implant, the containing cavity penetrates through the near end and the far end of the catheter, the near end of the catheter is communicated with the air cavity, and when the piston piece moves to the first position from the second position, air flow acting on the implant in the catheter is generated in the air cavity, so that the implant penetrates out of the far end of the catheter and is implanted into target tissue. By means of the structure, efficient and accurate conveying of implants can be achieved through airflow, and the risk of physical damage to the implants is remarkably reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a pneumatic implant device and system for implants. BACKGROUND

[0002] The current mainstream delivery method of lacrimal passage embolization or subcutaneous implant relies on mechanical clamping tools (such as forceps, injection forceps, etc.), but this method has the following limitations: it is difficult to accurately control the clamping force, which can easily cause structural deformation of the implant, especially for micro-embolization with a diameter of ≤0.5mm, extrusion can cause embolization failure; manual operation has low precision, and tissue mucosa can be easily scratched or implants can be misplaced and dropped due to fluctuations in force or angle deviation. In addition, young children, pets or patients with mental stress have low cooperation, and it takes more time to clamp the embolization implant with forceps, and the success rate is low. SUMMARY

[0003] In view of the above technical problems in the prior art, the present application provides a pneumatic implant device and system for implants, which can realize efficient and accurate delivery of implants by air flow, and significantly reduce the risk of physical damage to the implants.

[0004] The embodiments of the present application disclose a pneumatic implant device for implants, which is used for implanting implants into lacrimal passages or subcutaneously. The pneumatic implant device comprises: a movable assembly comprising a syringe and a piston member movably arranged in the syringe, a gas cavity located in the syringe is formed between the piston member and the distal end of the syringe, and the piston member has at least a first position and a second position in the syringe, the piston member in the first position is arranged closer to the distal end of the syringe than the piston member in the second position; a catheter having a receiving cavity for accommodating the implant, the receiving cavity penetrates through the proximal end and the distal end of the catheter, the proximal end of the catheter is in communication with the gas cavity, and when the piston member moves from the second position to the first position, an air flow acting on the implant in the catheter will be generated in the gas cavity, so that the implant is pierced out through the distal end of the catheter and implanted into the target tissue.

[0005] In some embodiments, the movable assembly further comprises an elastic member arranged in the syringe, the elastic member is located in the gas cavity, and the elastic member is used to apply an acting force to the piston member to move it from the second position to the first position.

[0006] In some embodiments, the pneumatic implant device further comprises a connecting member, the distal end of the syringe and the proximal end of the catheter respectively extend into the connecting member, and are both in sealed connection with the connecting member, so that the proximal end of the catheter is in communication with the gas cavity through the connecting member.

[0007] In some embodiments, the connecting member comprises a rigid structure and a connecting shell covering the rigid structure, the proximal end of the catheter is sealingly connected with the rigid structure, and the distal end of the syringe extends into the connecting shell.

[0008] In some embodiments, the connecting shell is provided with a sealing member, the sealing member is sleeved on the distal end of the syringe, and the distal end of the syringe is sealingly connected with the connecting member.

[0009] In some embodiments, the connecting shell is formed with a communication cavity extending through both ends thereof, the communication cavity has a first cavity for accommodating the distal end of the syringe and a second cavity for connecting with the proximal end of the catheter, the cross-sectional area of the first cavity is greater than that of the second cavity, the rigid structure is located in the second cavity, and the sealing member is located in the first cavity.

[0010] In some embodiments, the cavity wall of the accommodating cavity is protruded to form a limiting structure, and the limiting structure is used for clamping the implant.

[0011] In some embodiments, the limiting structure is a plurality of limiting structures, the plurality of limiting structures are symmetrically or discretely arranged on the cavity wall of the accommodating cavity, and are used in cooperation with the implant; wherein the clamping cavity formed by the proximal ends of the plurality of limiting structures cooperatively arranged is not greater than the outer contour size of the implant.

[0012] In some embodiments, the distal end of the accommodating cavity is formed with a flared structure, the limiting structure is arranged close to the movable assembly relative to the flared structure, and the flared structure is used for enabling the implant to enter the accommodating cavity.

[0013] The embodiments of the present application also disclose a pneumatic implant system for an implant, comprising the pneumatic implant device for an implant according to any one of the above embodiments, and further comprising an electrically connected pneumatic driving unit and a control assembly, the pneumatic driving unit at least acts on the piston member, and the control assembly is used for sending a control instruction for enabling the piston member to move to the first position or the second position to the pneumatic driving unit.

[0014] Compared with the prior art, the beneficial effects of the embodiment of the application are that the piston has at least a first position and a second position in the injection barrel, and when the piston moves from the second position to the first position, the air cavity formed between the piston and the distal end of the injection barrel will generate air flow acting on the implant in the catheter, so that the implant is pushed out through the distal end of the catheter and implanted into the target tissue, thereby achieving efficient and accurate delivery of the implant by air flow, significantly reducing the risk of physical damage to the implant, and effectively avoiding micro-injury to the tissue in the implantation path. Especially suitable for implanting tear ducts, subcutaneous fillers, and other implantation scenarios, it can achieve precise delivery of the implant and overcome the problems of low operation precision, implant damage, and tissue micro-injury caused by traditional implantation tools. BRIEF DESCRIPTION OF DRAWINGS

[0015] In the drawings, which are not necessarily drawn to scale, like numerals can describe similar components throughout the several views. The drawings are intended to illustrate various embodiments in accordance with the application and are not intended to limit the application, nor is the application limited to the embodiments disclosed. Like reference numerals can be used to denote like components throughout the specification and claims. Such embodiments are illustrative rather than limiting in nature and are not intended to exclude embodiments that utilize structural, and / or other modifications, or combinations of parts not expressly disclosed. The drawings are intended to be illustrative rather than limiting in nature.

[0016] Figure 1 FIG. 1 is a structural schematic diagram of a pneumatic implantation device according to an embodiment of the application, in which the piston is shown in the first position; Figure 2 FIG. 2 is a structural schematic diagram of a pneumatic implantation device according to an embodiment of the application, in which the piston is shown in the second position; Figure 3 FIG. 3 is a structural schematic diagram of a movable assembly of a pneumatic implantation device according to an embodiment of the application; Figure 4 FIG. 4 is a structural schematic diagram of a connecting piece of a pneumatic implantation device according to an embodiment of the application; Figure 5 FIG. 5 is a structural schematic diagram of a catheter of a pneumatic implantation device according to an embodiment of the application; Figure 6 FIG. 6 is a structural block diagram of a pneumatic implantation system for an implant according to an embodiment of the application.

[0017] Components represented by reference numerals in the drawings: 100, pneumatic implant system for implant; 101, pneumatic implant device for implant; 102, pneumatic drive unit; 103, control assembly; 1, movable assembly; 11, syringe barrel; 12, piston member; 13, elastic member; 14, plug-in structure; 2, catheter; 21, accommodating cavity; 22, limiting structure; 23, flared structure; 3, connecting member; 31, rigid structure; 32, connecting housing; 33, sealing member; 34, first cavity; 35, second cavity. DETAILED DESCRIPTION

[0018] In order for those skilled in the art to better understand the technical solutions of the present application, the present application will be described in detail below in conjunction with the drawings and specific embodiments. The embodiments of the present application will be further described in detail below in conjunction with the drawings and specific embodiments, but are not as limitations to the present application.

[0019] The "first", "second" and similar words used in the present application do not represent any order, number or importance, but are only used to distinguish different parts. "Include" or "contain" and similar words mean that the elements before the word cover the elements listed after the word, and do not exclude the possibility of also covering other elements. "Up", "down", "left", "right" and the like are only used to represent relative positional relationship, and when the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0020] In the present application, when it is described that a specific device is located between a first device and a second device, there can be an intervening device between the specific device and the first device or the second device, or there can be no intervening device. When it is described that a specific device is connected to other devices, the specific device can be directly connected to the other devices without an intervening device, or it can not be directly connected to the other devices with an intervening device.

[0021] All terms used in the present application (including technical terms or scientific terms) have the same meaning as understood by those skilled in the art to which the present application belongs, unless otherwise specifically defined. It should also be understood that terms defined in general dictionaries should be interpreted to have meanings consistent with their meanings in the context of the relevant technology, and should not be interpreted in an idealized or excessively formalized sense, unless otherwise defined explicitly herein.

[0022] Techniques, methods and equipment known to those skilled in the relevant art can not be discussed in detail, but in appropriate cases, the techniques, methods and equipment should be considered as part of the specification.

[0023] The embodiments of the present application disclose a pneumatic implant device 101 for implant, which is used for implanting an implant into a tear duct or subcutaneously. As shown in the drawings, the pneumatic implant device 101 for implant comprises a pneumatic drive unit 102, a control assembly 103, a movable assembly 1 and a catheter 2. Figures 1 to 3As shown, the pneumatic implantation device comprises a movable assembly 1 and a catheter 2. The movable assembly 1 comprises a syringe 11 and a piston 12 movably arranged in the syringe 11, the piston 12 and the distal end of the syringe 11 form a gas cavity in the syringe 11, and the piston 12 has at least a first position and a second position in the syringe 11, the piston 12 in the first position is arranged closer to the distal end of the syringe 11 than the piston 12 in the second position. The catheter 2 has a receiving cavity 21 for accommodating an implant, the receiving cavity 21 extends through the proximal end and the distal end of the catheter 2, the proximal end of the catheter 2 is in communication with the gas cavity, when the piston 12 moves from the second position to the first position, the gas cavity will generate a gas flow acting on the implant in the catheter 2, so that the implant is implanted into the target tissue through the distal end of the catheter 2. Wherein, Figure 1 The piston 12 shown in FIG. 1 is in the first position, Figure 2 The piston 12 shown in FIG. 2 is in the second position.

[0024] It should be noted that the above-mentioned pneumatic implantation device 101 for implant can be used by the operator on the lacrimal passage or subcutaneous of the user, the proximal end referred to in the present application is the side close to the operator and away from the user, and the distal end is the side close to the user. The proximal end and the distal end referred to in the following are intended to be as such.

[0025] The diameter of the above-mentioned implant can be not more than 1mm, preferably not more than 0.5mm, that is, the pneumatic implantation device is particularly used for implanting micro-implants.

[0026] Before inserting the distal end of the catheter 2 into the lacrimal passage or subcutaneous, the piston 12 can be moved to the second position, so that after the distal end of the catheter 2 is inserted into the lacrimal passage or subcutaneous, the piston 12 is moved from the second position to the first position, so as to avoid the problem of the catheter 2 sucking tissue outward caused by moving the piston 12 to the second position after the catheter 2 is inserted.

[0027] After the distal end of the catheter 2 is inserted into the lacrimal passage or subcutaneous, the piston 12 is moved from the second position to the first position, so that the gas flow acting on the implant in the catheter 2 is generated in the gas cavity, thereby realizing that the implant is implanted into the target tissue through the distal end of the catheter 2.

[0028] The above-mentioned gas cavity will be compressed to generate a directional gas flow acting on the implant when the piston 12 moves from the second position to the first position, that is, a directional force capable of making the implant pass through the catheter 2 is generated.

[0029] The barrel wall of the injection barrel 11 can be formed with a first scale structure to clearly identify the position of the piston 12 in the injection barrel 11, i.e. to realize the visualization and clarity of the position of the piston 12. Especially for the scenario of manually pulling the injection barrel 11, through the first scale structure on the barrel wall of the injection barrel 11, the operator can quickly determine the position of the piston 12 in the injection barrel 11, thereby accurately controlling the position of the piston 12.

[0030] The piston 12 can be sealingly connected to the barrel wall of the injection barrel 11. Specifically, the distal end of the piston 12 can be provided with an elastic sealing structure, and the piston 12 is sealingly connected to the barrel wall of the injection barrel 11 through the elastic sealing structure to ensure that the airflow generated in the air cavity can act on the implant in the catheter 2 in a directional manner.

[0031] The movement of the piston 12 in the injection barrel 11 can be achieved by a pneumatic driving unit 102 or manually by an operator. The manual implementation by the operator can reduce the use cost of the device, and the pneumatic driving unit 102 can improve the accuracy of implantation and use convenience. Preferably, the movement of the piston 12 in the injection barrel 11 can be achieved by the pneumatic driving unit 102. The pneumatic driving unit 102 is at least used to drive the piston 12 to make a linear reciprocating motion under control. For example, the pneumatic driving unit 102 adopts a structure such as an electric cylinder, a linear motor, a stepping motor driving system, or a servo motor driving system to realize the linear reciprocating motion of the piston 12 in the injection barrel 11 between the first position and the second position. For the scenario realized by the pneumatic driving unit 102, the barrel wall of the injection barrel 11 can not be formed with the first scale structure. At this time, the displacement distance of the piston 12 can be directly controlled by the pneumatic driving unit 102 without the need for determination in combination with the first scale structure.

[0032] The inner wall of the catheter 2 can be formed with a friction layer, and the friction coefficient of the friction layer can be less than or equal to 0.05. In this way, the implant can be stably placed in the accommodation cavity 21 without being separated from the accommodation cavity 21 under the action of force, and the airflow generated in the air cavity can also make the implant quickly pass through the accommodation cavity 21. Specifically, the friction layer can be a diamond-like carbon (DLC) nano coating.

[0033] The pipe wall of the catheter 2 can be provided with a second scale structure. When the implant is placed in the catheter 2, the implantation depth of the implant can be directly determined according to the second scale structure, thereby increasing the accuracy of the operation. Of course, the pipe wall of the catheter 2 can not be provided with the second scale structure, and the implantation depth of the implant can be determined according to the length of the catheter 2 itself. The present application does not make a specific limitation in this regard.

[0034] The inner diameter of the catheter 2 can be sub-millimeter, so as to adapt to the micro-implant.

[0035] The catheter 2 can be made of a flexible material, such as polytetrafluoroethylene or medical silicone, so as to increase the adaptability of the catheter 2. In addition, the catheter 2 can be multiple, and the multiple catheters 2 can be of different sizes, specifically, different inner diameters and / or lengths, so as to adapt to different implants.

[0036] The catheter 2 can be cylindrical, or other shapes, such as rectangular, which is not limited in the present application. The shape of the catheter 2 is adapted to the shape of the implant, so as to stably accommodate the implant.

[0037] The distal end of the catheter 2 can be provided with an auxiliary positioning structure, such as a fluorescent imaging marker (e.g. bismuth compound coating), so as to facilitate effective and rapid positioning of the distal end of the catheter 2, and further increase the implanting accuracy.

[0038] The flow rate of the gas flow generated by the gas cavity can be controlled by adjusting the total stroke of the piston 12 from the second position to the first position, so as to meet the corresponding biological safety conditions (e.g. the flow rate is not greater than 50 m / s), that is, the first position and / or the second position can be adjusted according to the required flow rate, rather than being fixed. When the pneumatic implanting device is applied to tear duct implantation, the flow rate should be not greater than 20 m / s; when the pneumatic implanting device is applied to other scenarios, the flow rate should be between 5 m / s and 30 m / s, and in the subcutaneous implantation scenario, the flow rate can be not greater than 12 m / s.

[0039] The piston 12 has at least a first position and a second position in the syringe 11, and when the piston 12 moves from the second position to the first position, the gas cavity formed between the piston 12 and the distal end of the syringe 11 will generate a gas flow acting on the implant in the catheter 2, so that the implant is inserted into the target tissue through the distal end of the catheter 2. In this way, the implant is efficiently and accurately delivered by the gas flow, which significantly reduces the risk of physical damage to the implant and effectively avoids micro-injury to the tissue caused by the implant in the implantation path. It is especially suitable for implantation scenarios such as tear duct implantation of lacrimal canaliculus plug and subcutaneous implantation of subcutaneous filler, and can achieve accurate delivery of the implant and overcome the problems of low operation precision, implant damage and tissue micro-injury caused by traditional implantation tools.

[0040] In some embodiments, as shown in Figures 1 to 3 The elastic member 13 is located in the gas cavity and is used to apply a force to the piston 12 to move it from the second position to the first position.

[0041] In this way, the elastic member 13 can ensure that the piston member 12 can be smoothly and quickly moved from the second position to the first position, ensuring the stability of the movement of the piston member 12.

[0042] When the piston member 12 is in the second position, the elastic member 13 accumulates elastic potential energy, and when the force acting on the piston member 12 is removed, the elastic member 13 can move the piston member 12 from the second position to the first position. Of course, when the pneumatic driving unit 102 drives the piston member 12 to reciprocate, the elastic member 13 can be understood as a structure that assists the piston member 12 to move to the first position, to ensure that the air chamber can stably generate air flow acting on the implant.

[0043] The elastic member 13 described above can be a tension spring or a spring plate structure, and the present application does not make specific limitations thereon, as long as it can stably apply a force to the piston member 12.

[0044] In the case of a tension spring, the spring stiffness coefficient k can satisfy the following formula: ; where k is the spring stiffness coefficient (N / m); x is the pre-compression amount of 1mm to 10mm; and F is the spring force.

[0045] The relationship between the stroke S of the elastic member 13 and the maximum air flow rate under the bio-safety condition satisfies the following condition: ; where k is the spring stiffness coefficient (N / m); x is the pre-compression amount (m), S is the stroke (m), is the cross-sectional area of the air chamber (m²); is the cross-sectional area of the conduit 2; R is the flow resistance, i.e., the resistance of the conduit 2 to the air flow, which depends on the size (such as the length L and the inner diameter D) of the conduit 2 and the viscosity of air .

[0046] The flow resistance of the conduit 2 described above is determined by the following formula: .

[0047] In some embodiments, as shown in Figure 1 , Figure 2 and Figure 4 , the pneumatic implant device further comprises a connecting member 3, the distal end of the syringe 11 and the proximal end of the conduit 2 are respectively inserted into the connecting member 3, and are both in sealed connection with the connecting member 3, so that the proximal end of the conduit 2 is in communication with the air chamber through the connecting member 3.

[0048] Thus, the connection between the syringe 11 and the catheter 2 can be ensured to be sealed by the connector 3, i.e. the connector 3 is sealingly connected with the distal end of the syringe 11 and the proximal end of the catheter 2, respectively. In this way, the structure of the pneumatic implantation device can be simplified as much as possible while ensuring the sealing, so that the structure is more reasonable.

[0049] In the assembly of the pneumatic implantation device, the syringe 11 and the catheter 2 can be respectively installed at the two ends of the connector 3, so as to realize the sealing connection between the syringe 11 and the catheter 2 through the connector 3, and ensure that the airflow generated in the air cavity can act on the implant in the catheter 2. After the syringe 11, the connector 3 and the catheter 2 are installed, the piston 12 can be pulled to the second position, and the implant can be placed in the catheter 2 while the piston 12 is kept in the second position. Then, the distal end of the catheter 2 is inserted into the tear duct or subcutaneously, and the piston 12 is moved from the second position to the first position, so as to generate an airflow that can act on the implant, and realize that the implant is implanted into the target tissue through the distal end of the catheter 2.

[0050] The distal end of the syringe 11 can be formed with a plug-in structure 14, and the syringe 11 is plugged into the connector 3 through the plug-in structure 14. The plug-in structure 14 can be a taper, for example.

[0051] In some embodiments, as shown in Figure 1 , Figure 2 and Figure 4 , the connector 3 includes a rigid structure 31 and a connecting shell 32 covering the rigid structure 31, and the proximal end of the catheter 2 is sealingly connected with the rigid structure 31, and the distal end of the syringe 11 extends into the connecting shell 32. It can be understood that the inner cavity of the catheter 2 is connected with the inside of the syringe 11 through the connecting shell 32 of the connector 3.

[0052] In this way, the syringe 11 and the connecting shell 32 can be stably and sealingly connected, and the rigid structure 31 can ensure the structural strength at the position where the catheter 2 is installed, so as to avoid the problem that the connecting shell 32 is bent and the catheter 2 is damaged.

[0053] The rigid structure 31 can be made of a medical-grade metal (such as stainless steel).

[0054] The connecting shell 32 can be made of a specific polymer (such as polycarbonate) with biocompatibility.

[0055] In some embodiments, as shown in Figure 1 , Figure 2 and Figure 4 , a sealing member 33 is arranged in the connecting shell 32, and the sealing member 33 is sleeved on the distal end of the syringe 11, so that the distal end of the syringe 11 is sealingly connected with the connector 3.

[0056] In this way, the sealing effectiveness and stability of the connection between the connecting housing 32 and the syringe 11 can be ensured by the sealing member 33.

[0057] The inner wall of the connecting housing 32 can be provided with a groove, and the sealing member 33 can be arranged in the groove, and the distal end of the syringe 11 extends into the connecting housing 32 and circumferentially abuts against the sealing member 33.

[0058] The sealing member 33 can include, but is not limited to, an O-ring, an X-ring, and other medical-grade sealing structures.

[0059] In some embodiments, as shown in Figure 1 , Figure 2 and Figure 4 , the connecting housing 32 is formed with a communication cavity extending through both ends thereof, the communication cavity has a first cavity 34 for accommodating the distal end of the syringe 11 and a second cavity 35 for connecting with the proximal end of the catheter 2, the cross-sectional area of the first cavity 34 is greater than that of the second cavity 35, the rigid structure 31 is located in the second cavity 35, and the sealing member 33 is located in the first cavity 34.

[0060] In this way, by the first cavity 34 for accommodating the distal end of the syringe 11 and the second cavity 35 for connecting with the proximal end of the catheter 2, the cross-sectional area of the first cavity 34 is greater than that of the second cavity 35, the structural rationality of the connecting member 3 can be ensured, and the overall size of the connecting member 3 is minimized, so that the connecting member 3 is adapted to the sizes of the connected syringe 11 and catheter 2.

[0061] In some embodiments, as shown in Figure 1 , Figure 2 and Figure 4 , the cavity wall of the accommodating cavity 21 is protruded to form a limiting structure 22, and the limiting structure 22 is used for clamping the implant.

[0062] In this way, the implant can be stably clamped by the limiting structure 22, and the implant can be prevented from being damaged and separated from the catheter 2.

[0063] The limiting structure 22 can be a concentric circular structure, and the inner diameter thereof is equal to or slightly smaller than the diameter of the implant, so as to fix the implant.

[0064] In some embodiments, the catheter 2 can be replaced with different sizes (inner diameter and length), and the sizes and shapes of the limiting structures 22 in different catheters 2 can also be the same or different. Specifically, the limiting structure 22 can be customized according to the shape of the implant (such as a lacrimal canaliculus plug, a subcutaneous filler, or other minimally invasive implants).

[0065] In some embodiments, as shown in Figure 1As shown, the plurality of limiting structures 22 are symmetrically or discretely arranged on the cavity wall of the accommodating cavity 21 for cooperating with the implant; wherein the clamping cavity formed by the proximal ends of the plurality of limiting structures 22 has a size not greater than the outer contour size of the implant.

[0066] In this way, the plurality of limiting structures 22 can cooperate with the implant to ensure the effectiveness of the position limitation of the implant.

[0067] The limiting structure 22 can be configured as a convex arch structure, which can act on the implant without damaging the implant.

[0068] When the plurality of limiting structures 22 are discretely arranged on the cavity wall of the accommodating cavity 21, the maximum distance between the convex surfaces of the limiting structures 22 is equal to or slightly smaller than the diameter of the implant for fixing the implant.

[0069] In some embodiments, as shown, Figure 2 As shown, the distal end of the accommodating cavity 21 is formed with a flared structure 23, and the limiting structures 22 are arranged relative to the flared structure 23 of the movable assembly 1, and the flared structure 23 is used for the implant to enter the accommodating cavity 21.

[0070] In this way, the flared structure 23 can reduce the risk of collision of the implant entering the accommodating cavity 21, that is, it is beneficial for the implant to enter the accommodating cavity 21 and reduce the probability of collision.

[0071] The distal end of the flared structure 23 has a larger cross-sectional area than the proximal end, specifically, the flared structure 23 can be tapered, and after the implant enters the accommodating cavity 21, it will be gradually tightened by the flared structure 23, to ensure that the implant is stably installed while not being damaged.

[0072] The proximal end of the catheter 2 is sealingly connected with the rigid structure 31 of the connecting piece 3, and the distal end is formed with the flared structure 23 described above to accommodate the implant.

[0073] The following describes the implantation of an implant into the tear duct by a pneumatic implantation device, which can be a lacrimal canaliculus plug. In implanting the implant into the tear duct, the stiffness coefficient of the elastic member 13 can be 250 N / m, the pre-compression amount x = 2 mm, the inner diameter of the syringe 11 can be 4.5 mm, the stroke accuracy of the syringe 11 is ± 0.5 mm, and the maximum safe stroke is 15 mm. By adjusting the stroke of the elastic member 13, the precise output of different flow rates of air flow can be achieved. The distal end of the syringe 11 extends into the connecting member 3, and the elastic member 13, such as a fluororubber O-ring (hardness 70 ± 5 Shore A, pressure resistance ≥ 0.3 MPa), is arranged in the groove of the connecting member 3, and the leakage rate is < 0.1 mL / min. The rigid structure 31 is made of medical stainless steel, which cooperates with the connecting shell 32 to form a bending-resistant composite structure. The taper angle of the groove on the connecting shell 32 where the sealing member 33 is installed ranges from 10° ± 5°. The inner diameter of the catheter 2 can be = 0.6 mm (adapted to a 0.5 mm diameter lacrimal canaliculus plug), and the length can be 22 mm. The inner wall of the catheter 2 can be coated with a DLC coating (friction coefficient ≤ 0.05). The limiting structure 22 in the catheter 2 is discretely arranged on the cavity wall of the accommodation cavity 21, and the spacing between the limiting structures 22 is 0.52 mm. The outer wall of the catheter 2 is marked with a scale of 0 mm to 22 mm (every 2 mm), and the key points of 8 mm, 12 mm and 18 mm are highlighted.

[0074] The implantation operation process of the above-mentioned pneumatic implantation device for implanting the implant into the tear duct is as follows: first pull the piston member 12 to a stroke of 10 mm, and then place a 0.5 mm diameter lacrimal canaliculus plug in the limiting structure 22; the distal end of the catheter 2 is inserted into the punctum, and the positioning depth is 8 mm; loosen the piston member 12 to generate air flow, and the air flow drives the lacrimal canaliculus plug to be implanted into the lacrimal canaliculus, so that the position error ≤ 1 mm can be achieved.

[0075] The following explanation uses the subcutaneous implantation of an implant using a pneumatic implantation device as an example. In this case, the implant can be a subcutaneous drug-releasing embolization. When implanting the above-mentioned implant subcutaneously, the stiffness coefficient of the elastic element 13 can be 1000 N / m, the pre-compression amount x = 0.5 mm, the inner diameter of the syringe 11 can be 7 mm, the stroke accuracy of the syringe 11 is ±0.5 mm, and the maximum safe stroke is 6 mm. By adjusting the stroke of the elastic element 13, precise output of different airflow velocities can be achieved. The distal end of the syringe 11 extends into the connector 3, and the groove of the connector 3 is fitted with the elastic element 13, such as a fluororubber O-ring (hardness 70±5 Shore A, pressure resistance ≥0.3 MPa), with a leakage rate <0.1 mL / min. The rigid structure 31 is made of medical-grade stainless steel, which, together with the connecting shell 32, forms a bending-resistant composite structure. The cone angle of the groove on the connecting shell 32 where the sealing element 33 is installed ranges from 10°±5°. The inner diameter of catheter 2 can be 0.5 mm (suitable for subcutaneous drug-releasing emboli with a diameter of 0.4 mm), and the length can be 50 mm. The inner wall of catheter 2 can be coated with DLC (coefficient of friction ≤ 0.05). The limiting structure 22 inside catheter 2 is a concentric circle structure, and the diameter of the concentric circle structure can be 0.42 mm. The cone angle of the conical inlet of the flared structure 23 can be 70°. The outer wall of catheter 2 is marked with graduations from 0 mm to 50 mm (every 2 mm), and the key points of 4 mm, 5 mm, 6 mm, and 12 mm are highlighted.

[0076] The implantation procedure of the above-mentioned pneumatic implantation device for subcutaneous implantation is as follows: first, pull the piston 12 to a stroke of 4 mm, and then place the subcutaneous drug-releasing embolism in the limiting structure 22; the puncture needle establishes a subcutaneous channel; the distal end of the catheter 2 is inserted into the lacrimal punctum at a positioning depth of 4 mm to 8 mm; the piston 12 is released to generate airflow, which drives the subcutaneous drug-releasing embolism to be implanted into the lacrimal canaliculus. This operation can achieve a positional error of ≤1 mm.

[0077] This application also discloses a pneumatic implantation system 100 for implants. For example... Figure 5 Figure 5 Figure 5 Figure 6 As shown, the pneumatic implantation system 100 for implants includes the pneumatic implantation device 101 for implants according to any of the above embodiments, and also includes a pneumatic drive unit 102 and a control component 103 electrically connected. The pneumatic drive unit 102 acts on the piston 12 at least, and the control component 103 is used to send a control command to the pneumatic drive unit 102 to move the piston 12 to a first position or a second position.

[0078] It should be noted that the control assembly 103 can be built with electronic elements such as timers, comparators, registers, digital logic circuits, or implemented with processor chips such as single-chip microcomputers, microprocessors, programmable logic controllers (PLC), digital signal processors (DSP), field programmable gate arrays (FPGA), programmable logic arrays (PLA), application-specific integrated circuits (ASIC), and their peripheral circuits.

[0079] The above-mentioned pneumatic driving unit 102 is at least used to drive the piston piece 12 to move linearly under control, for example, the pneumatic driving unit 102 adopts structures such as electric cylinders, linear motors, stepping motor driving systems, and servo motor driving systems to realize the linear reciprocating movement of the piston piece 12 in the syringe 11 between the first position and the second position. For the scenario realized by the pneumatic driving unit 102, the first scale structure can not be formed on the barrel wall of the syringe 11, at this time, the displacement distance of the piston piece 12 can be directly controlled by the pneumatic driving unit 102, without the need to determine in combination with the first scale structure.

[0080] The pneumatic implant system using the above-mentioned pneumatic implant device can have at least the first position and the second position of the piston piece 12 in the syringe 11, and when the piston piece 12 moves from the second position to the first position, the air cavity formed between the piston piece 12 and the distal end of the syringe 11 will generate air flow acting on the implant in the catheter 2, so that the implant passes out through the distal end of the catheter 2 and is implanted into the target tissue, thereby realizing efficient and accurate delivery of the implant by air flow, significantly reducing the risk of physical damage to the implant, and effectively avoiding microtrauma to the tissue in the implant path. Especially suitable for implantation scenarios such as lacrimal canaliculus plug implantation into the lacrimal duct and subcutaneous filler implantation into the subcutaneous tissue, which can realize accurate delivery of the implant and overcome the problems of low operation precision, implant damage, and tissue microtrauma that may be caused by traditional implant tools.

[0081] In addition, although exemplary embodiments have been described herein, the scope of their range includes any and all embodiments based on the present application with equivalent elements, modifications, omissions, combinations (for example, solutions in which various embodiments are crossed), adaptations, or changes. The elements in the claims will be broadly interpreted based on the language used in the claims, and are not limited to the examples described in the specification or during the implementation of the present application, which examples will be interpreted as non-exclusive.

[0082] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be used, which will be apparent to those of ordinary skill in the art upon reviewing the above description. Additionally, the various features described above can be grouped together or divided into separate features for the purpose of simplifying the present disclosure. This should not be interpreted as a requirement to practice any claim in its full scope unless the claim does not encompass additional embodiments to those that can be claimed. The scope of the application should therefore be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including” and “comprising” are open-ended, that is, are intended to mean one or more items, products, or methods which can be purchased, used, or collected, e.g., “including” a fruit may mean that the fruit can be an apple, an orange, a banana, a grape, or any other fruit. Further, the terms “first” and “second” are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0083] The above embodiments are only exemplary embodiments of the present application, and are not intended to limit the present application, and the protection scope of the present application is defined by the claims. Those skilled in the art can make various modifications or equivalent replacements to the present application within the spirit and protection scope of the present application, and such modifications or equivalent replacements should also be considered to fall within the protection scope of the present application.

Claims

1. A pneumatic implantation device for implants, characterized in that, For implanting implants into the lacrimal duct or subcutaneous tissue, pneumatic implantation devices include: An active component includes an injection barrel and a piston movably disposed within the injection barrel, wherein an air cavity is formed between the piston and the distal end of the injection barrel within the injection barrel, and the piston has at least a first position and a second position within the injection barrel, wherein the piston in the first position is disposed closer to the distal end of the injection barrel relative to the piston in the second position. The catheter has a receiving cavity for receiving the implant, the receiving cavity extending through the proximal and distal ends of the catheter, the proximal end of the catheter being connected to the air chamber. When the piston moves from the second position to the first position, an airflow is generated in the air chamber acting on the implant within the catheter, causing the implant to pass through the distal end of the catheter and be implanted into the target tissue.

2. The pneumatic implantation device for implants according to claim 1, characterized in that, The movable component also includes an elastic element disposed within the syringe barrel, the elastic element being located within the air chamber, the elastic element being used to apply a force to the piston element to move it from the second position to the first position.

3. The pneumatic implantation device for implants according to claim 1, characterized in that, The pneumatic implantation device also includes a connector, in which the distal end of the syringe and the proximal end of the catheter extend into the connector and are sealed to it, so that the proximal end of the catheter is connected to the air cavity through the connector.

4. The pneumatic implantation device for implants according to claim 3, characterized in that, The connector includes a rigid structure and a connecting shell covering the rigid structure. The proximal end of the catheter is sealed to the rigid structure, and the distal end of the syringe extends into the connecting shell.

5. The pneumatic implantation device for implants according to claim 4, characterized in that, The connecting housing is provided with a sealing element, which is sleeved on the outside of the distal end of the syringe, so that the distal end of the syringe is sealed to the connecting element.

6. The pneumatic implantation device for implants according to claim 5, characterized in that, The connecting housing has a through cavity extending through both ends. The through cavity has a first cavity for accommodating the distal end of the syringe and a second cavity for connecting to the proximal end of the catheter. The cross-sectional area of ​​the first cavity is larger than that of the second cavity. The rigid structure is located in the second cavity, and the sealing element is located in the first cavity.

7. The pneumatic implantation device for implants according to claim 1, characterized in that, The cavity wall of the accommodating cavity protrudes to form a limiting structure, which is used to clamp the implant.

8. The pneumatic implantation device for implants according to claim 7, characterized in that, The limiting structure comprises multiple structures, which are symmetrically or discretely disposed on the cavity wall of the accommodating cavity for cooperating with the implant; wherein the size of the clamping cavity formed by the close proximity of the multiple limiting structures is not greater than the outer contour size of the implant.

9. The pneumatic implantation device for implants according to claim 7, characterized in that, The distal end of the accommodating cavity has a flared structure, and the limiting structure is positioned close to the movable component relative to the flared structure. The flared structure is used to allow the implant to enter the accommodating cavity.

10. A pneumatic implantation system for implants, characterized in that, The device includes a pneumatic implantation apparatus for an implant as described in any one of claims 1 to 9, further comprising an electrically connected pneumatic drive unit and a control component, wherein the pneumatic drive unit acts at least on the piston member, and the control component is configured to send a control command to the pneumatic drive unit to move the piston member to the first position or the second position.

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