Balloon pretreatment device and balloon pretreatment method

Abstract

The present invention provides a balloon pretreatment device and a balloon pretreatment method, belonging to the field of medical device technology, comprising: a first pressing plate; a second pressing plate, which can be relatively opened and closed and buckled on the first pressing plate, and forms a plurality of through-containment cavities with the first pressing plate, wherein the cavities are suitable for placing a balloon loaded with a mold, and one end of the balloon is an inflation end suitable for connecting to an inflation device; a heating device, which is provided on at least one of the first pressing plate and the second pressing plate, wherein the installation direction of the heating device is perpendicular to the extension direction of the accommodating cavity, and is suitable for being electrically connected to a control module; a thermocouple, which is provided on the first pressing plate and / or the second pressing plate with the heating device, and is suitable for being electrically connected to the control module. The balloon pretreatment device of the present invention heats and inflates the balloon, and a protrusion extending from the mold is formed on the surface of the balloon; when the balloon and the stent are pressed and gripped, the protrusion extends out of the stent, thereby increasing the holding force of the stent and preventing the stent from detaching from the balloon during the pushing process.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a balloon pretreatment device and a balloon pretreatment method. Background Art

[0002] Percutaneous coronary intervention (PCI) is the primary treatment for cardiovascular disease, characterized by minimal trauma, rapid recovery, and few side effects. During treatment, a balloon catheter and stent are typically used together. The balloon catheter carries the stent into the lesion and expands it, thereby restoring the vessel's lumen diameter and improving blood circulation.

[0003] The retention force of a stent is an important indicator for evaluating the quality of a product. Currently, a crimping machine is used to crimp the stent onto a folded balloon, and the balloon is not pre-treated before crimping.

[0004] Since the balloon is not pre-treated before gripping, the stent's retention force is provided solely by the gripping force. When the gripping force is too low, the stent's retention force is low, which can easily cause the stent to fall off before reaching the lesion during surgery, increasing surgical risks and even causing medical accidents. When the gripping force is too high, the balloon can be damaged. Summary of the Invention

[0005] Therefore, the technical problem to be solved by the present invention is to overcome the problem in the prior art that the balloon is not subjected to any pretreatment before being pressed and gripped with the stent, and the stent is pressed onto the balloon only by the pressing and gripping force, which makes it difficult to ensure the holding force of the stent and easily causes the stent to fall off during the operation. Therefore, a device for pretreatment of the balloon is provided to improve the holding force of the stent after it is pressed onto the balloon.

[0006] The present invention also provides a balloon pretreatment method, which can improve the holding force of the stent after it is pressed onto the balloon when the balloon is pressed and gripped with the stent.

[0007] In order to solve the above technical problems, the present invention provides a balloon pretreatment device, comprising:

[0008] first pressing plate;

[0009] The second pressing plate can be relatively snapped onto the first pressing plate and form a plurality of through-containment cavities with the first pressing plate, wherein the cavities are suitable for accommodating the balloon loaded with the tool, and one end of the balloon is an inflation end suitable for connecting to the inflation device;

[0010] a heating device, provided on at least one of the first pressing plate and the second pressing plate, the installation direction of the heating device being perpendicular to the extension direction of the accommodating cavity and being adapted to be electrically connected to the control module;

[0011] The thermocouple is provided on the first pressing plate and / or the second pressing plate having the heating device and is suitable for being electrically connected to the control module.

[0012] As a preferred solution, it also includes:

[0013] The base has a bottom surface serving as a support surface, and two positioning blocks are spaced apart on the top surface, a positioning groove is formed between the two positioning blocks, and the first pressing plate is detachably arranged in the positioning groove.

[0014] As a preferred solution, both of the two positioning blocks have guide grooves corresponding one-to-one to the accommodating cavities.

[0015] As a preferred solution, it also includes:

[0016] The adsorption device comprises two groups, which are respectively arranged on the two positioning blocks and are suitable for adsorbing and fixing the two ends of the balloon to be pretreated.

[0017] As a preferred solution, the adsorption device is a permanent magnet.

[0018] As a preferred solution, the first pressing plate has a plurality of first grooves arranged in parallel, and the second pressing plate has second grooves corresponding to the first grooves one by one, and the first grooves and the second grooves can be relatively buckled to form the accommodating cavity.

[0019] As a preferred solution, the first pressing plate is hingedly connected to the second pressing plate.

[0020] As a preferred solution, the controller internally comprises a control module and a power module electrically connected to the control module, the control module is electrically connected to the thermocouple, and the power module is electrically connected to the heating device.

[0021] As a preferred solution, the inflation device has a plurality of inflation tubes, and the inflation tubes are suitable for being detachably connected to the inflation ends of the balloon.

[0022] A balloon pretreatment method, using the balloon pretreatment device described in any one of the above schemes to pretreatment the balloon on the balloon catheter, comprising the following steps:

[0023] Folding the balloon and placing it in the jig, and placing the balloon loaded with the jig into the accommodating cavity formed between the first pressing plate and the second pressing plate;

[0024] Balloon protection sheaths are respectively provided at both ends of the balloon, and the two balloon protection sheaths are respectively in contact with the two ends of the balloon;

[0025] The first pressing plate and the second pressing plate are buckled together to heat and inflate the balloon in the accommodating cavity.

[0026] The technical solution of the present invention has the following advantages:

[0027] 1. The balloon pretreatment equipment provided by the present invention places a balloon loaded with a tool in a receiving cavity formed by the buckling of a first pressing plate and a second pressing plate, wherein the tool is consistent with the shape and size of the stent; the balloon is heated and inflated simultaneously, and a protrusion extending from the tool is formed on the surface of the balloon; when the balloon and the stent are pressed and gripped together, in addition to the pressing and gripping force, the protrusion also extends out of the stent, thereby increasing the holding force of the stent, preventing the stent from detaching from the balloon during the pushing process, and reducing surgical risks.

[0028] 2. The balloon pretreatment equipment provided by the present invention positions the first pressing plate through the positioning groove to prevent the balloon from shifting during the heating and inflation process, which would affect the pretreatment effect.

[0029] 3. The balloon pretreatment equipment provided by the present invention has a guide groove which plays a guiding role during the placement of the balloon, thereby preventing radial movement during the placement process.

[0030] 4. The balloon pretreatment equipment provided by the present invention has an adsorption device that better maintains the balloon in the accommodating cavity, wherein the adsorption device uses a permanent magnet; by pre-introducing an iron wire into the balloon, during the heating and inflation process, the iron wire and the adsorption device are adsorbed to prevent axial movement of the balloon in the accommodating cavity.

[0031] 5. The balloon pretreatment equipment provided by the present invention has an inflation device with multiple inflation tubes, which can inflate multiple balloons simultaneously, thereby accelerating the balloon treatment efficiency.

[0032] 6. In the balloon pretreatment method provided by the present invention, the two ends of the balloon are connecting ends, and the balloon protective sheath protects the two ends of the balloon to prevent damage to other parts caused by heating and inflation; in addition, the two ends of the tool are respectively abutted against the end of the balloon protective sheath to axially limit the tool to prevent axial movement of the tool during the preheating process. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0034] Figure 1 It is a schematic diagram of the three-dimensional structure of the balloon pretreatment device provided in the present invention.

[0035] Figure 2 Schematic diagram of the three-dimensional structure of the forming carrier Figure 1 .

[0036] Figure 3 Schematic diagram of the three-dimensional structure of the forming carrier Figure 2 .

[0037] Figure 4 This is a flowchart of balloon pretreatment.

[0038] Description of reference numerals:

[0039] 1. Molding vehicle; 2. Controller; 3. Inflating device; 4. Heating device; 5. Thermocouple; 6. Base; 7. Positioning block; 8. First pressure plate; 9. Second pressure plate; 10. First groove; 11. Second groove; 12. Guide groove; 13. Adsorption device; 14. Handle; 15. Cooling fan; 16. Buzzer; 17. Emergency stop button; 18. Rotary switch; 19. Power indicator light; 20. Power indicator light; 21. Alarm indicator light; 22. Inflating tube; 23. Control module. DETAILED DESCRIPTION

[0040] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0041] In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate and simplify the description of the present invention. They are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation, and therefore should not be construed as limitations on the present invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0042] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0043] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0044] like Figure 1 As shown, the balloon pretreatment device provided in this embodiment includes: a forming carrier 1, a controller 2 and an inflation device 3. A heating device 4 and a thermocouple 5 are provided inside the forming carrier 1.

[0045] like Figure 2 、 Figure 3 As shown, the forming carrier 1 includes: a base 6, a positioning block 7, a first pressure plate 8 and a second pressure plate 9. The first pressure plate 8 and the second pressure plate 9 are both made of aluminum alloy. The base 6 and the positioning block 7 are both made of polytetrafluoroethylene material. The polytetrafluoroethylene material has the characteristics of high temperature resistance, corrosion resistance, high lubricity, non-adhesion and non-toxicity. The bottom surface of the base 6 is the supporting surface. The two positioning blocks 7 are connected to the top surface of the base 6 at intervals, and a rectangular positioning groove is formed between the two positioning plates. The first pressure plate 8 is a rectangular structure and is placed in the positioning groove. The width of the first pressure plate 8 is equal to the width of the positioning groove and can achieve clearance fit. A plurality of first grooves 10 are provided on the top surface of the first pressure plate 8, and the plurality of first grooves 10 are arranged in parallel and at equal intervals. The second pressure plate 9 is hingedly connected to the top surface of the first pressure plate 8, and the second pressure plate 9 can be hingedly fitted with the top surface of the first pressure plate 8; the side of the second pressure plate 9 that can be fitted with the top surface of the first pressure plate 8 is provided with multiple second grooves 11 that correspond one-to-one with the first grooves 10; when the second pressure plate 9 is hingedly fitted with the first pressure plate 8, the first grooves 10 and the second grooves 11 are buckled one-to-one to form multiple left-right through accommodating cavities.

[0046] like Figure 2 、 Figure 3 As shown, the top surface of the positioning block 7 is provided with a guide groove 12 corresponding to the first groove 10, and the guide groove 12 passes through the left and right sides of the positioning block 7; the top surface of the positioning block 7 is provided with a rectangular mounting groove passing through its front and rear sides, and an adsorption device 13 is connected to the mounting groove. Here, the adsorption device 13 is a permanent magnet. The balloon loaded with the tool is placed in the accommodating cavity formed by the first groove 10 and the second groove 11, and the external catheter connected to the proximal end of the balloon extends through the guide groove 12. The guide groove 12 enables the balloon to be better retained in the accommodating cavity; in order to prevent the balloon from axial movement during the pretreatment process, it is necessary to insert an iron wire into the balloon before pretreatment so that the iron wire adsorbs the adsorption device 13, thereby locking the axial position of the balloon.

[0047] like Figure 2 、 Figure 3As shown, a heating device 4 is installed inside each of the first pressing plate 8 and the second pressing plate 9. The heating device 4 is installed perpendicular to the extension direction of the first groove 10 and the second groove 11. Here, the heating device 4 is a heating tube. The first pressing plate 8 and the second pressing plate 9 are each installed with a thermocouple 5, and each thermocouple 5 is electrically connected to the control module 23. During the heating process, the thermocouple 5 monitors the temperature of the first pressing plate 8 and the second pressing plate 9 to ensure that the balloon reaches its glass transition temperature, so that a protrusion extending from the mold is formed and maintained on the balloon surface.

[0048] like Figure 2 、 Figure 3 As shown, a handle 14 is connected to the side of the second pressing plate 9, which facilitates pulling the second pressing plate 9 through the handle 14 to separate and fit the first pressing plate 8.

[0049] like Figure 1 As shown, the controller 2 is provided with the control module 23, a power module electrically connected to the control module 23, a cooling fan 15, a buzzer 16 and an operation panel, and the operation panel is provided with an emergency stop button 17, a rotary switch 18, a power indicator light 19, a power indicator light 20 and an alarm indicator light 21.

[0050] like Figure 1 As shown, the inflation device 3 is provided with multiple inflation tubes 22, and the inflation tubes 22 can be detachably connected to the inflation ends of the balloons, and can inflate multiple balloons at the same time, thereby accelerating the processing efficiency of the balloons.

[0051] like Figure 4 As shown, balloon pretreatment method:

[0052] Loading a tool of corresponding specifications on the folded balloon, wherein the shape and size of the tool are consistent with those of the stent, and the tool is located between the distal development mark and the proximal development mark of the balloon;

[0053] The proximal and distal ends of the balloon are respectively sleeved on the balloon protective sheath tubes. The distance between the two balloon protective sheath tubes is equal to the length of the tool. The two ends of the tool are seamlessly abutted against the ends of the balloon protective sheath tubes to limit the tool axially and avoid axial movement of the tool during the preheating process.

[0054] Place the balloon loaded with the tool into the accommodating cavity formed between the first pressing plate 8 and the second pressing plate 9, and connect the inflation end of the balloon to the inflation device 3;

[0055] Buckle the first pressing plate 8 and the second pressing plate 9 together, heat and inflate the balloon in the accommodating cavity at a preset temperature and a preset pressure, and maintain the temperature for a period of time;

[0056] After the pretreatment is completed, the balloon protective sheath at the distal end of the balloon is removed, and then the balloon protective sheath at the proximal end of the balloon is moved to the outer tube of the balloon dilation catheter, and finally the tool and the balloon protective sheath at the proximal end of the balloon are removed in turn.

[0057] The pre-treated balloon surface forms a plurality of protrusions extending from the mold; during the compression and gripping process between the stent and the balloon, the protrusions can extend from the holes in the outer wall of the stent, thereby increasing the holding force of the stent and preventing the stent from separating from the balloon during the pushing process.

[0058] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. A balloon pretreatment method, characterized in that: A balloon pretreatment device is used to pretreatment the balloon on the balloon catheter, wherein the balloon pretreatment device comprises: a first pressing plate (8); a second pressing plate (9) which can be relatively opened and closed on the first pressing plate (8) and forms a plurality of through-containment cavities with the first pressing plate (8), wherein the accommodating cavities are suitable for placing the balloon loaded with the mold, and one end of the balloon is an inflation end suitable for connection with the inflation device (3); a heating device (4) which is provided on at least one of the first pressing plate (8) and the second pressing plate (9), wherein the heating device (4) The installation direction is perpendicular to the extension direction of the accommodating cavity and is suitable for being electrically connected to the control module (23); the thermocouple (5) is provided on the first pressing plate (8) and / or the second pressing plate (9) having the heating device (4) and is suitable for being electrically connected to the control module (23); the first pressing plate (8) has a plurality of first grooves (10) arranged in parallel, and the second pressing plate (9) has a second groove (11) corresponding to the first grooves (10) one by one, and the first grooves (10) and the second grooves (11) can be relatively engaged to form the accommodating cavity; It also includes: an inflation device (3) having a plurality of inflation tubes (22), wherein the inflation tubes (22) are adapted to be detachably connected to the inflation ends of the balloons; the plurality of inflation tubes can inflate a plurality of balloons simultaneously; The balloon pretreatment method includes the following steps: After folding the balloon, the balloon is placed in the mold, and the balloon loaded with the mold is placed in the accommodating cavity formed between the first pressing plate (8) and the second pressing plate (9); the shape and size of the mold are consistent with the shape and size of the stent; Balloon protection sheaths are respectively sheathed at both ends of the balloon, and the two balloon protection sheaths are respectively in contact with the two ends of the balloon; and the two ends of the tool are respectively in contact with the ends of the balloon protection sheaths without a gap; The first pressing plate (8) and the second pressing plate (9) are buckled together to heat and inflate the balloon in the accommodating cavity; during the heating process, the temperature of the first pressing plate (8) and the second pressing plate (9) is detected by the thermocouple (5) to ensure that the balloon can reach its own glass transition temperature, so that a protrusion extending out of the mold is formed and maintained on the surface of the balloon; A plurality of protrusions extending out of the tool are formed on the surface of the pretreated balloon.

2. The balloon pretreatment method according to claim 1, characterized in that: Also includes: The base (6) has a bottom surface serving as a support surface and two positioning blocks (7) spaced apart on the top surface. A positioning groove is formed between the two positioning blocks (7), and the first pressing plate (8) is detachably disposed in the positioning groove.

3. The balloon pretreatment method according to claim 2, characterized in that: Both positioning blocks (7) have guide grooves (12) corresponding one-to-one to the accommodating cavities.

4. The balloon pretreatment method according to claim 3, characterized in that: Also includes: The adsorption device (13) has two groups, which are respectively arranged on the two positioning blocks (7) and are suitable for adsorbing and fixing the two ends of the balloon to be pretreated.

5. The balloon pretreatment method according to claim 4, characterized in that: The adsorption device (13) is a permanent magnet.

6. The balloon pretreatment method according to claim 1, characterized in that: The first pressing plate (8) is hingedly connected to the second pressing plate (9).

7. The balloon pretreatment method according to any one of claims 1 to 5, characterized in that: Also includes: The controller (2) has a control module (23) and a power module electrically connected to the control module (23) therein, the control module is electrically connected to the thermocouple (5), and the power module is electrically connected to the heating device (4).

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