Positioning device, perforation system and balloon perforation method

Abstract

The present application relates to a positioning device, a perforation system and a balloon perforation method, the positioning device comprising a main body part and a fixing part, the main body part having a containing chamber and a chamber entrance communicating with the containing chamber, the main body part having a hollowed-out area provided with a hollowed-out unit hole communicating with the containing chamber, and the fixing part being arranged on the main body part. The main body part can fix and contain a balloon in an expanded state, and part of the surface area of the balloon is exposed through the hollowed-out unit hole of the hollowed-out area on the main body part. After the balloon is fixed, the exposed surface area of the balloon can be subjected to a perforation operation through the hollowed-out unit hole, and a designed regular breaking hole is processed. The balloon is delivered to a lesion position, and the liquid medicine in the balloon can be accurately released to the lesion position through the breaking hole, so as to achieve accurate release of the medicine, solve the problems of poor accuracy and rough release amount control caused by non-discriminatory coverage treatment, reduce the use of medicine, and effectively avoid waste of medicine and reduce medical costs.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a positioning device, a perforation system, and a balloon perforation method. Background Technology

[0002] Currently, the prevalence of cardiovascular disease risk factors is evident, leading to a continuous increase in the number of people suffering from cardiovascular diseases. The prevention and treatment of cardiovascular diseases are increasingly becoming a global focus of attention.

[0003] Interventional medical devices are becoming increasingly common in the treatment of various cardiovascular diseases. Balloon dilation catheters are a tool used for endovascular angioplasty and are now widely used in the clinical medicine of percutaneous transluminal angioplasty and percutaneous transluminal angioplasty. They have gone through three stages of development: PTCA, BMS, and DES. In particular, the advent of drug-eluting stents has achieved great success in the treatment of vascular stenosis. However, drug-eluting stents still have a restenosis rate of about 5%, and the inflammation caused by the drug coating can inhibit the endothelialization process of blood vessels after drug-eluting stent implantation. Therefore, drug-coated balloons (DCBs) have emerged, providing a new option for the long-term situation after drug-eluting stent implantation.

[0004] Drug-coated balloons are made by uniformly coating the surface of a balloon with an anti-proliferative drug. After delivery to the lesion site, the drug is released to inhibit the proliferation of vascular smooth muscle cells. Drug-coated balloons deliver drugs indiscriminately over the lesion area, resulting in significant drawbacks such as poor precision and inconsistent release volume control. Summary of the Invention

[0005] Therefore, it is necessary to provide a positioning device, a perforation system, and a balloon perforation method to address the technical problem of poor drug release accuracy in drug-coated balloons.

[0006] A positioning device, the positioning device comprising:

[0007] The main body has an internal receiving chamber with an inlet for the balloon to enter the receiving chamber. The main body has a hollow area with a hollow unit hole that communicates with the receiving chamber and exposes a portion of the surface area of ​​the balloon located inside the receiving chamber.

[0008] A fixing part is provided on the main body and is used to fix the balloon.

[0009] In one of the embodiments, the main body part adopts a tubular component, a tube inner cavity of the tubular component constitutes the accommodating chamber, a first tube opening of a first end of the tubular component constitutes the chamber entrance, and the fixing part is arranged at a second tube opening of a second end of the tubular component.

[0010] In one of the embodiments, the fixing part is in sealed connection with the second tube opening; and / or, the fixing part is in detachable connection with the second tube opening.

[0011] In one of the embodiments, at least one part of a tube section of the tubular component is a straight tube, and the hollowed-out region is located on the straight tube of the tubular component.

[0012] In one of the embodiments, the hollowed-out region comprises a plurality of the hollowed-out unit holes, and the plurality of the hollowed-out unit holes are distributed along a circumferential direction of the tubular component.

[0013] In one of the embodiments, a marking part is arranged on the main body part, and is used for marking a circumferential fixing angle of the balloon in the accommodating chamber.

[0014] In one of the embodiments, the marking part is a marking notch arranged at the first end of the tubular component, and the marking notch can expose a part of a surface area of the balloon.

[0015] In one of the embodiments, the positioning device comprises:

[0016] An adapter part is in clamping connection with the main body part.

[0017] In one of the embodiments, at least one part of a tube section of the adapter part is a straight tube.

[0018] In one of the embodiments, the positioning device comprises:

[0019] A coaxial connecting part is used for connecting the adapter part with the main body part, and is used for keeping the straight tube of the adapter part and the straight tube of the main body part sharing a same rotation axis.

[0020] A puncture system, comprising:

[0021] The positioning device;

[0022] A rotating device is used for driving the positioning device to rotate;

[0023] A filling device is used for filling and discharging a filling material to the balloon in the positioning device;

[0024] A perforation device for applying a perforation force to a part of the surface area of the balloon exposed to the hollow unit holes of the positioning device.

[0025] A balloon perforation method based on the positioning device or the perforation system, comprising the following steps:

[0026] Placing the balloon into the accommodating cavity of the positioning device, fixing the balloon by the fixing part, and exposing the surface area of the balloon that needs to be perforated to the hollow unit holes of the positioning device;

[0027] Filling the balloon with a filling material, and applying a perforation force to the surface area of the balloon exposed to the hollow unit holes in the inflated state of the balloon.

[0028] In one of the embodiments, the following steps are included:

[0029] Discharging the filling material of the balloon, and taking out the balloon from the accommodating cavity of the positioning device;

[0030] Changing the angle of the balloon placed into the accommodating cavity, fixing the balloon by the fixing part, and exposing other surface area of the balloon that needs to be perforated to the hollow unit holes of the positioning device;

[0031] Filling the balloon with a filling material, and applying a perforation force to the surface area of the balloon exposed to the hollow unit holes in the inflated state of the balloon.

[0032] The positioning device, the perforation system, and the balloon perforation method described above, the main part can fix and accommodate the balloon in the inflated state, the part of the surface area of the balloon is exposed through the hollow unit holes of the hollow area on the main part, the balloon is fixed, and the perforation operation can be performed on the surface area of the balloon exposed through the hollow unit holes, and the designed breaking holes are processed. After the balloon is delivered to the lesion position, the liquid medicine in the balloon can be accurately released to the lesion position through the breaking holes, the accurate release of the medicine is achieved, the problems of poor accuracy and rough release amount control caused by non-discriminatory coverage treatment are solved, and through the reduction of the use of the medicine, the waste of the medicine can be effectively avoided, the medical cost is reduced, and the side effects caused by the medicine itself are reduced. BRIEF DESCRIPTION OF DRAWINGS

[0033] Figure 1 The structural schematic diagram of the positioning device provided for one embodiment of the application is shown in the figure;

[0034] Figure 2 The cross-sectional schematic diagram of the positioning device provided for one embodiment of the application is shown in the figure;

[0035] Figure 3 The structural schematic diagram of the positioning device provided for another embodiment of the application is shown in the figure;

[0036] Figure 4 A structural schematic diagram of a positioning device provided for another embodiment of the present application is shown in FIG. 3;

[0037] Figure 5 A structural schematic diagram of a positioning device provided for another embodiment of the present application is shown in FIG. 3;

[0038] Figure 6 A structural schematic diagram of a perforating system provided for an embodiment of the present application is shown in FIG. 4.

[0039] Reference signs:

[0040] 0001、balloon;

[0041] 1000、positioning device;2000、rotating device;3000、filling device;4000、perforating device;

[0042] 1100、main body part;1200、fixing part;1300、marking part;1400、adapting part;1500、coaxial connecting part;

[0043] 1110、accommodating cavity;1120、cavity inlet;1130、hollowed region;1140、first end;1150、second end;

[0044] 1131、hollowed unit hole;1141、first pipe opening;1151、second pipe opening;

[0045] A、rotating axis. DETAILED DESCRIPTION

[0046] In order to make the above objectives, features and advantages of the present application more apparent, specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. It will be apparent, however, to one skilled in the art that the present application can be practiced without using some or all of these specific details, and that the present application is not limited to the specific embodiments disclosed below.

[0047] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0048] In addition, the terms "first", "second", etc. are used herein only to describe different instances, and are not used to denote or imply relative importance or a number of indications of the technical features indicated. Thus, the technical features defined with "first", "second", etc. can explicitly or implicitly include at least one of the technical features. In the description of the present application, the meaning of "a plurality of" is at least two, such as two, three, etc., unless otherwise explicitly specified and limited.

[0049] In the present application, unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "connecting", "fixing" and the like should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise explicitly limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0050] In the present application, unless otherwise explicitly specified and limited, the first feature is "on" or "under" the second feature, which can be direct contact between the first and second features, or indirect contact between the first and second features through an intermediate medium. Moreover, the first feature "above", "over" and "on" the second feature can be directly above or obliquely above the first feature, or only indicate that the horizontal height of the first feature is higher than that of the second feature. The first feature "below", "under" and "under" the second feature can be directly below or obliquely below the first feature, or only indicate that the horizontal height of the first feature is less than that of the second feature.

[0051] It should be noted that when an element is referred to as "fixed to" or "disposed on" another element, it can be directly on the other element or there can be a middle element. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there can be a middle element. The terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used herein are only for illustrative purposes, and do not represent the only embodiment.

[0052] Reference Figures 1 to 6As shown, an embodiment of the present application provides a positioning device 1000, which comprises a main body part 1100 and a fixing part 1200, the main body part 1100 has a containing chamber 1110, the containing chamber 1110 has a chamber entrance 1120 for the balloon 0001 to enter into the containing chamber 1110, wherein the main body part 1100 has a hollowed region 1130, the hollowed region 1130 is provided with a hollowed unit hole 1131, the hollowed unit hole 1131 penetrates through the containing chamber 1110, the hollowed unit hole 1131 is used for exposing part of the surface area of the balloon 0001 in the containing chamber 1110, and the fixing part 1200 is arranged on the main body part 1100 and used for fixing the balloon 0001.

[0053] The balloon 0001 refers to various balloons 0001 used for medical operations, which are not limited herein, and the balloon 0001 can be filled with a filling material in the inner cavity to form an inflated state, and the balloon 0001 can discharge the filling material in the inner cavity to form a deflated state, and the filling material is not limited to various gases and various liquids.

[0054] The function of the main body part 1100 is to provide a framework for the balloon 0001 to be fixed in the perforation operation, and the containing chamber 1110 of the main body part 1100 is used for fixing the balloon 0001, and the main body part 1100 is provided with the chamber entrance 1120 which communicates with the containing chamber 1110, so that the balloon 0001 can enter and exit the containing chamber 1110 through the chamber entrance 1120, for example, the balloon 0001 is in a deflated state and enters the containing chamber 1110, and then is converted into an inflated state after being filled with a filling material, so that the outer wall of the balloon 0001 is in force contact with the inner wall of the containing chamber 1110, and the balloon 0001 is positioned relative to the main body part 1100, and the fixing part 1200 can be connected with the balloon 0001 to fix the balloon 0001 in the containing chamber 1110 of the main body part 1100 at a fixed angle and position.

[0055] The hollowed-out area 1130 provided on the main body 1100 is an area for performing a perforation operation on the balloon 0001, and the hollowed-out area 1130 is provided with one or more hollowed-out unit holes 1131, which can be constructed in various regular shapes, combinations of various regular shapes, and various irregular shapes, complex shapes, etc. After the balloon 0001 is exposed by the hollowed-out unit holes 1131, the perforation device 4000 for performing a perforation operation on the balloon 0001, such as a laser, can perform a perforation operation on the exposed surface area of the balloon 0001 through the hollowed-out unit holes 1131. Therefore, the number and specific shape of the hollowed-out unit holes 1131 depend on the pattern of perforations to be formed on the balloon 0001. For example, the shape and size of the hollowed-out unit holes 1131 are completely consistent with the pattern of perforations, or the shape of the hollowed-out unit holes 1131 is consistent with the pattern of perforations but the outline of the hollowed-out unit holes is larger than the outline of the pattern of perforations, or the hollowed-out unit holes 1131 adopt a large-area rectangular hole to expose all the perforations, and the like. Those skilled in the art can set them according to the needs, which are not limited herein.

[0056] Therefore, the main body 1100 can fix and accommodate the balloon 0001, especially the balloon 0001 in the inflated state. The main body 1100 exposes part of the surface area of the balloon 0001 through the hollowed-out unit holes 1131 of the hollowed-out area 1130, and fixes the balloon 0001. After the balloon 0001 is fixed, a perforation operation can be performed on the exposed surface area of the balloon 0001 through the hollowed-out unit holes 1131 to process the designed regular perforations. After the balloon 0001 is delivered to the lesion site, the balloon 0001 can accurately release the liquid medicine inside the balloon 0001 to the lesion site through the perforations, achieve accurate drug release, solve the problem of poor accuracy and rough control of the release amount caused by non-discriminatory coverage treatment, and effectively avoid drug waste, reduce medical costs, and alleviate the side effects caused by the drug itself by reducing the use of the drug.

[0057] It should be noted that the medical balloon 0001 is usually made of TPU (thermoplastic polyurethane), PA (polyamide), PE (polyethylene), POC (citric acid), and PET (polyester resin), etc. It has the characteristics of softness, easy folding, easy deformation, inflatable under pressure, and contractible under pressure. It is difficult to form a reasonable and effective fixation of the balloon 0001 when performing a perforation operation on the surface of the balloon 0001, and it is difficult to stably maintain the inflated state for the perforation operation of the perforation device 4000 such as a laser. In addition, when controlling the rotation of the balloon 0001 during the perforation process, the soft balloon 0001 will also generate a certain torque, deviate from the predetermined coordinates, and cannot be accurately positioned and effectively processed.

[0058] Therefore, in order to ensure that the perforation operation of the balloon 0001 is carried out smoothly, the main body part 1100 serves as a basic framework to fix the balloon 0001 in the inflated state, and the outer wall of the balloon 0001 in the inflated state is in force contact (i.e., pressed against each other) with the inner wall of the accommodating chamber 1110, so that the balloon 0001 in the inflated state is stably maintained in the accommodating chamber 1110 of the main body part 1100, providing possible operating conditions for the perforation operation, which is equivalent to switching the short board of the balloon 0001 to the main body part 1100, eliminating the problems of the balloon 0001 being not easy to fix, being easily pinched, and rotating out of sync.

[0059] The main body part 1100 can be constructed in various structural forms and materials, as long as it can provide the accommodating chamber 1110 for accommodating and fixing the balloon 0001, and according to different shapes of the balloon 0001 to be processed, the accommodating chamber 1110 can be constructed with different chamber shapes in a targeted manner, so that the balloon 0001 matches the structure shape after being placed in the accommodating chamber 1110, for example, the shape of the balloon 0001 in the inflated state and the chamber shape of the accommodating chamber 1110 are both cylindrical with straight sections, cylindrical with curved sections, and cylindrical with folded sections, etc. Different shapes of the balloon 0001 depend on the application scenarios and functional requirements of the balloon 0001, and a person skilled in the art can set according to the requirements, which are not limited here.

[0060] In one embodiment, the main body part 1100 adopts a tubular part which has an internal tube cavity and tube openings at both ends, so the tubular part can be directly used as the main body part 1100, and the tube cavity of the tubular part constitutes the accommodating chamber 1110, the first tube opening 1141 of the first end 1140 of the tubular part constitutes the chamber entrance 1120, and the fixing part 1200 is arranged at the second tube opening 1151 of the second end 1150 of the tubular part. The balloon 0001 also generally has a long cylindrical shape, so the tubular part is adapted to the shape of the balloon 0001.

[0061] The fixing part 1200 can be arranged at any position of the tubular part, and the fixing part 1200 can be detachably or non-detachably assembled on the tubular part, as long as it can achieve the fixation of the balloon 0001, wherein the fixation of the fixing part 1200 to the balloon 0001 can be direct fixation or indirect fixation of the balloon 0001 through a lead or other components. In one embodiment, the fixing part 1200 is arranged in detachable connection with the second tube opening 1151 of the tubular part, and the fixing part 1200 is in sealed connection with the second tube opening 1151, so that the accommodating chamber 1110 is in good pressure maintaining state when the balloon 0001 is filled with the filling material.

[0062] As shown above, medical balloons (0001) are typically made of materials such as TPU (thermoplastic polyurethane), PA (polyamide), PE (polyethylene), POC (citric acid ester), and PET (polyester resin). They are characterized by their softness, foldability, deformability, inflatability upon inflation, and shrinkability upon depressurization. However, due to the insufficient softness and rigidity of the balloon's surface, concentricity and alignment along its length cannot be achieved. Concentricity refers to the equidistant distance from all points on the upper surface of the straight cylindrical section of the balloon to its central axis. Alignment refers to the fact that all points on the upper surface of the straight cylindrical section of the balloon lie on the same plane.

[0063] Therefore, see Figure 1 and Figure 2 As shown, in one embodiment, at least a portion of the tubular component is a straight tubular section, and the hollowed-out area 1130 is located within the straight tubular section of the tubular component. The fact that at least a portion of the tubular component is a straight tubular section is equivalent to the tubular component being entirely a straight tubular section, thus forming a straight tubular main body 1100. Alternatively, it can be formed by having some sections as straight tubular sections and combining them with other sections of different shapes such as curved tubular sections, bent tubular sections, and conical tubular sections to form the entire main body 1100, thereby adapting to the shape of the balloon 0001. Those skilled in the art can set it according to their needs, and no limitation is made here.

[0064] Therefore, by forming a force contact (i.e., mutual compression) between the outer wall of the inflated balloon 0001 and the inner wall of the receiving chamber 1110, at least a portion of the balloon 0001 can be shaped into a straight cylindrical form. The straight cylindrical form can maintain good concentricity and straightness. When rotating the balloon 0001, it is only necessary to control the rotation of the main body 1100, without applying any force to the balloon 0001 itself, thus preventing deformation of the balloon 0001 and maintaining good concentricity and straightness. When performing the perforation operation, it is only necessary to process the straight cylindrical structure of the balloon 0001 through the hollow area 1130.

[0065] Good concentricity and collimation ensure that when the balloon 0001 rotates along the fixed axis A, the surface area on the balloon 0001 where the perforation operation is to be performed will not fluctuate in height, and will always maintain a stable distance from the perforation device 4000. For example, when the perforation device 4000 is a laser, the laser head of the laser will always be kept at the same height as the surface area of ​​the balloon 0001, ensuring the stability of perforation and improving the processing accuracy.

[0066] See Figures 3 to 5As shown, in one embodiment, the hollowed region 1130 comprises a plurality of hollowed unit holes 1131, for example, two or three hollowed unit holes 1131, and the plurality of hollowed unit holes 1131 are distributed along the circumference of the tubular component, thus, when the tubular component is rotated, the perforating device 4000 can switch to different hollowed unit holes 1131, and thus, the continuous perforating operation on the circumference of the balloon 0001 can be implemented.

[0067] The fixing part 1200 can be a guide wire twist, a nut or the like, and is configured according to the size of the accommodating chamber 1110. The fixing part 1200 can be made of a metal material or a non-metal material. The length of the fixing part 1200 can be greater than 5 mm, for example, the length of the fixing part 1200 is 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, etc. The main body part 1100 can be made of a metal tube such as stainless steel, nickel-titanium, aluminum alloy, etc. The length of the main body part 1100 can be greater than 20 mm, for example, the length of the main body part 1100 is 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, etc. The wall thickness of the main body part 1100 can be greater than 0.2 mm and less than 3 mm, for example, the wall thickness of the main body part 1100 is 0.2 mm, 0.5 mm, 0.8 mm, 1 mm, 1.5 mm, 1.8 mm, 2 mm, 2.5 mm, 3 mm, etc. The hollowed region 1130 on the main body part 1100 can be set according to the size of the balloon 0001, for example, the length of the hollowed region 1130 is greater than or equal to the length of the balloon 0001.

[0068] In one embodiment, the main body part 1100 is provided with a marking part 1300. The marking part 1300 can have various structures, for example, a hole formed on the main body part 1100 or a marking line, a marking needle, etc. provided on the main body part 1100. The marking part 1300 can be used to mark the circumferential fixing angle of the balloon 0001 in the accommodating chamber 1110 of the main body part 1100. Referring to Figure 6 As shown, the circumferential fixing angle represents the rotation angle of the balloon 0001 relative to the main body part 1100 when the balloon 0001 is assembled in the accommodating chamber 1110 of the main body part 1100 and then rotates along the axis of the tubular component. Therefore, when the perforating device 4000 performs a perforating operation on a surface region of the balloon 0001, the current angle of the balloon 0001 relative to the main body part 1100 can be marked by the marking part 1300. If it is necessary to change the circumferential fixing angle of the balloon 0001 relative to the main body part 1100, the marking part 1300 can be used to continue marking, and the marking can make the perforating operation of each surface region of the balloon 0001 uniform.

[0069] In one embodiment, the marking portion 1300 is a marking notch formed in the first end 1140 of the tubular member, which can expose a part of the surface area of the balloon 0001, so that a marking mark can be drawn on the corresponding position of the balloon 0001 by using the marking notch, thereby marking the angle of the balloon 0001 relative to the main body 1100. The marking notch can be one or more and arranged circumferentially, which can be set according to requirements without limitation.

[0070] The size of the marking notch can be set according to requirements. For example, the marking notch is a rectangular opening, and the length of the marking notch is between 1 mm and 5 mm, such as 1 mm, 2 mm, 3 mm, 4 mm, and 5 mm, and the width of the marking notch is between 1 mm and 5 mm, such as 1 mm, 2 mm, 3 mm, 4 mm, and 5 mm. The marking notch can be two or other even numbers, so that multiple marking notches are radially symmetrical on the main body 1100.

[0071] In one embodiment, the positioning device 1000 includes an adapter 1400, which can be detachably connected with the main body 1100, so that the main body 1100 and the balloon 0001 can be integrally driven and assembled to the rotating device 2000, such as the driving end of the rotating device 2000, and then indirectly connected with the main body 1100 through the adapter 1400 for driving, which is used to control the rotation of the main body 1100 and the balloon 0001, thereby achieving the perforation operation circumferentially on the balloon 0001.

[0072] The adapter 1400 can have various forms, such as a tubular structure, a clamping structure, a buckle structure, etc. In one embodiment, the adapter 1400 can be a tubular structure, and at least a part of the pipe body section of the adapter 1400 is a straight pipe body, which is equivalent to that the adapter 1400 can be entirely a straight pipe body to form a straight pipe-shaped adapter 1400, or can be formed by a part of the straight pipe body and other sections with different shapes such as a curved pipe body, a bent pipe body, a tapered pipe body, etc.

[0073] The adapter 1400 adopts a tubular structure and is adapted to the structure of the main body 1100, and the main body 1100 and the adapter 1400 both have at least a straight pipe body, so that the straight pipe body of the adapter 1400 and the straight pipe body of the tubular component share the same rotation axis A. Therefore, after the main body 1100 is assembled to the rotating device 2000 through the adapter 1400, the adapter 1400 and the main body 1100 have overall consistency, and the rotating device 2000 controls the adapter 1400 to rotate along the rotation axis A, which is equivalent to controlling the main body 1100 to rotate along the rotation axis A.

[0074] In one embodiment, the positioning device 1000 includes a coaxial connecting portion 1500, the adapter 1400 is connected to the main body 1100 through the coaxial connecting portion 1500, and the coaxial connecting portion 1500 is used to keep the straight pipe body of the adapter 1400 and the straight pipe body of the tubular component share the same rotation axis A, which not only ensures the coaxial consistency between the main body 1100 and the adapter 1400, but also facilitates the disassembly and assembly between the main body 1100 and the adapter 1400. The coaxial connecting portion 1500 can adopt a tubular structure, a clamping structure, a buckle structure, etc., which is not limited here.

[0075] Specifically referring to Figure 1 and Figure 2 The main body 1100 can be composed of a metal pipe with a length greater than 150 mm and a wall thickness between 0.2 mm and 3 mm, and the inner diameter of the metal pipe is set to the diameter of the balloon 0001 to be processed, so that the balloon 0001 can be easily placed into the lumen of the metal pipe. The hollow area 1130 can be rectangular, and the area of the hollow area 1130 can be set to one quarter of the entire outer surface of the metal pipe. The distance between the right end side of the hollow area 1130 and the first end 1140 of the metal pipe is between 5 mm and 10 mm, and the distance between the left end side of the hollow area 1130 and the second end 1150 of the metal pipe is between 5 mm and 10 mm, and the two distances can be equal or unequal. A mark notch is provided on the first end 1140 of the metal pipe for marking during the perforation process.

[0076] After the balloon 0001 is placed in the metal pipe, the left end of the balloon 0001 is fixed by the fixing portion 1200, so that the tapered reducing position of the left end of the balloon 0001 can be aligned with the left end side of the hollow area 1130, and the right end of the balloon 0001 is exposed from the metal pipe and inflated by the inflation device 3000. The inflation pressure can be maintained at 5 atm to 10 atm. A marker can be used to mark the tapered reducing position of the right end of the balloon 0001 at the mark notch, which is used to adjust the rotation angle of the balloon 0001.

[0077] The metal tube is assembled on the rotating device 2000, placed under the laser perforator, and the laser perforator is aligned with the hollowed-out area 1130. The balloon 0001 is perforated according to the designed perforation program. After one area of the balloon 0001 is perforated, the balloon 0001 is deflated, and the balloon 0001 is rotated to the appropriate angle according to the mark. The left end of the balloon 0001 is fixed in the metal tube again using the fixing part 1200, and the laser perforator is used to repeat the perforation operation on other areas of the balloon.

[0078] Specifically referring to Figure 3 As shown, the main body part 1100 can be matched with the adapter part 1400. The adapter part 1400 can use a metal tube with the same inner diameter as the outer diameter of the main body part 1100. The main body part 1100 and the adapter part 1400 are coaxially assembled by inserting the tube openings into each other, maintaining concentricity and collimation.

[0079] Specifically referring to Figure 4 As shown, the hollow unit holes 1131 of the hollowed-out area 1130 can be arranged in a plurality of equal intervals relative to the hollow unit holes 1131 shown in Figure 2 The area of the hollow unit holes 1131 shown in the hollowed-out area 1130 can be increased, that is, a plurality of equal-interval and larger-area hollow unit holes 1131 are distributed circumferentially in the hollowed-out area 1130. The distribution and size of the hollow unit holes 1131 match the areas of the balloon 0001 that need to be perforated and the areas that do not need to be perforated.

[0080] Specifically referring to Figure 5 As shown, the hollow unit holes 1131 of the hollowed-out area 1130 can be arranged in a plurality of equal intervals relative to the hollow unit holes 1131 shown in Figure 3 The area of the hollow unit holes 1131 shown in the hollowed-out area 1130 can be increased, that is, a plurality of equal-interval and larger-area hollow unit holes 1131 are distributed circumferentially in the hollowed-out area 1130. The distribution and size of the hollow unit holes 1131 match the areas of the balloon 0001 that need to be perforated and the areas that do not need to be perforated.

[0081] Referring to Figure 6 As shown, the present application also provides a perforation system, which includes the positioning device 1000, the rotating device 2000, the inflation device 3000, and the perforation device 4000. The rotating device 2000 is used to drive the positioning device 1000 to rotate. The inflation device 3000 is used to inflate and deflate the balloon 0001 in the positioning device 1000. The perforation device 4000 is used to apply a perforation force to the part of the surface area of the balloon 0001 exposed to the hollow unit holes 1131 of the positioning device 1000.

[0082] The specific structure, functional principle and technical effects of the positioning device 1000 are described in detail above, and thus will not be described again here. The rotating device 2000 can be a device capable of implementing rotating drive, such as a motor. The driving end of the rotating device 2000 is directly or indirectly connected with the positioning device 1000, so as to control the positioning device 1000 to implement rotating operation. The inflation device 3000 can adopt devices such as air pumps and liquid pumps according to different inflation substances, and can inflate gas or liquid into the balloon 0001 according to requirements. The inflation device 3000 can be connected with the balloon 0001 through a pipeline, and can also be assisted to assemble a pressure relief component such as a pressure relief valve to implement pressure control during the inflation process, so as to ensure the safety of work. The perforating device 4000 can be a device capable of exerting a perforating force and forming a perforating hole on the balloon 0001, for example, a laser perforating machine or a laser. The perforating force is a perforating laser.

[0083] The perforating system can set a program according to perforating requirements, and transfer the perforating requirements on the surface of the balloon 0001 into requirements of the positioning device 1000. That is, by controlling the rotation and angle adjustment of the positioning device 1000, the rotation and angle adjustment of the balloon 0001 are completed, so that the perforating operation of the balloon 0001 can be automatically performed, manual operation is reduced, and processing efficiency and processing precision are improved.

[0084] The present application also provides a balloon perforating method based on the positioning device 1000 or the perforating system, which includes the following steps: placing the balloon 0001 into the containing cavity 1110 of the positioning device 1000, fixing the balloon 0001 by using the fixing part 1200, exposing the surface area of the balloon 0001 that needs to be perforated to the hollow unit hole 1131 of the positioning device 1000, inflating the balloon 0001 with inflation substances, and applying a perforating force to the surface area of the balloon 0001 exposed to the hollow unit hole 1131 in the inflated state of the balloon 0001.

[0085] The balloon can accurately release the liquid medicine inside the balloon to the lesion position through the perforating hole after being delivered to the lesion position, so as to achieve accurate release of the medicine and solve the problems of poor accuracy and rough release amount control caused by indiscriminate coverage treatment. By transferring the perforating requirements on the surface of the balloon 0001 into requirements of the positioning device 1000, the perforating operation of the balloon 0001 can be automatically performed, manual operation is reduced, and processing efficiency and processing precision are improved.

[0086] With the method of placing the balloon 0001 into the accommodating cavity 1110 of the positioning device 1000 to perform perforation, the perforation operation can be continued on the circumference of the balloon 0001, and then the perforation holes can be formed on the balloon 0001 according to the requirements. Please refer to Figure 6 As shown, for the area on the balloon 0001 that has been exposed by one or more hollow unit holes 1131, when the perforation operation is completed at a certain position on the circumference of the balloon 0001, the main body 1100 can be controlled to rotate, and then the rotation operation of the balloon 0001 is performed, and other positions on the circumference of the balloon 0001 are continuously exposed to the perforation device 4000 such as a laser, and then the perforation operation is performed on the entire area on the balloon 0001 exposed to the hollow unit hole 1131.

[0087] Among them, the rotation of the balloon 0001 can expose different positions on the circumference of the balloon 0001 to the perforation device 4000 such as a laser in the same hollow unit hole 1131, or the rotation of the balloon 0001 can expose different positions on the circumference of the balloon 0001 to the perforation device 4000 such as a laser in other hollow unit holes 1131, which will depend on the area of the hollow unit hole 1131 opened by the main body 1100, and the distribution and number of the hollow unit hole 1131, etc. The person skilled in the art can select the appropriate exposure mode according to the actual perforation requirements of the balloon 0001, which is not limited here.

[0088] At the same time, the marking part 1300 can also mark the circumferential fixed angle of the balloon 0001 in the accommodating cavity 1110. Please refer to Figure 6 As shown, the circumferential fixed angle represents the rotation angle of the balloon 0001 relative to the main body 1100 when the balloon 0001 is assembled in the accommodating cavity 1110 of the main body 1100 and then rotates along the axis of the tubular part. Therefore, by replacing the circumferential fixed angle of the balloon 0001 relative to the main body 1100, other surface areas on the balloon 0001 that need to be perforated can also be exposed to the hollow unit hole 1131 of the positioning device 1000. Here, the other surface areas refer to the surface areas that have not been perforated and have not been exposed to the hollow unit hole 1131.

[0089] For example, during the perforation operation of the balloon 0001, after the perforation operation of a region of the balloon 0001 is completed, the inflation material of the balloon 0001 can be discharged to convert the balloon 0001 from the inflated state to the contracted state, so that the balloon 0001 can be taken out of the accommodating cavity 1110 of the positioning device 1000; then, the angle of the balloon 0001 placed in the accommodating cavity 1110 of the positioning device 1000 is changed, the balloon 0001 is fixed by the fixing part 1200 again, so that other surface regions of the balloon 0001 that need to be perforated are exposed to the hollow unit holes 1131 of the positioning device 1000, and the inflation material is filled into the balloon 0001, and the perforation force is applied to the surface regions of the balloon 0001 exposed to the hollow unit holes 1131 in the inflated state of the balloon 0001.

[0090] Therefore, in one embodiment, after a circumferential position of the balloon 0001 is perforated, the body part 1100 can be controlled to rotate the balloon 0001, so that each circumferential position of the balloon 0001 exposed to the hollow unit holes 1131 is exposed to the perforation device 4000 in turn, and then the perforation operation is performed on all the regions of the balloon 0001 exposed to the hollow unit holes 1131. Then, the rotation angle of the balloon 0001 relative to the body part 1100 during the axial rotation of the balloon 0001 along the axis of the tubular part is controlled, and the circumferential fixing angle of the balloon 0001 relative to the body part 1100 is changed, so that other surface regions of the balloon 0001 that need to be perforated are exposed to the hollow unit holes 1131 of the positioning device 1000, and the inflation material is filled into the balloon 0001, and the perforation force is applied to the surface regions of the balloon 0001 exposed to the hollow unit holes 1131 in the inflated state of the balloon 0001. Therefore, the perforation operation can be performed at any position of the balloon 0001 and cover all the surface regions of the balloon 0001 through the above two steps, and therefore, a person skilled in the art can select the regions and positions of the perforation operation according to the requirements, which are not limited herein.

[0091] The technical features of the above-described embodiments can be combined in any manner, and for the sake of brevity, all possible combinations of the technical features in the above-described embodiments are not described, but as long as the combinations of the technical features do not conflict, they should be considered as the scope of the present disclosure.

[0092] The above-described embodiments only express several implementation manners of the present application, and the description is relatively specific and detailed, but it should not be understood as a limitation on the scope of the patent. It should be pointed out that, for a person skilled in the art, several modifications and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. A positioning device, characterized in that The positioning device comprises: a main body portion having an accommodating chamber inside, the accommodating chamber having a chamber entrance for a balloon to enter into the accommodating chamber, wherein the main body portion has an open area provided with open unit holes penetrating through the accommodating chamber, the open unit holes being used to expose part of the surface area of the balloon in the accommodating chamber to perform a perforation operation on the exposed surface area of the balloon through the open unit holes; a fixing portion provided on the main body portion for fixing the balloon in an inflated state.

2. The positioning device of claim 1, wherein, The main body portion is a tubular component, the inner cavity of the tubular component constitutes the accommodating chamber, the first port of the first end of the tubular component constitutes the chamber entrance, and the fixing portion is provided at the second port of the second end of the tubular component.

3. The positioning device of claim 2, wherein, The fixing portion is in sealed connection with the second port; and / or the fixing portion is in detachable connection with the second port.

4. The positioning device of claim 2, wherein, At least one pipe body section of the tubular component is a straight pipe body, and the open area is located on the straight pipe body of the tubular component.

5. The positioning device of claim 2, wherein, The open area comprises a plurality of open unit holes, and the plurality of open unit holes are distributed along the circumference of the tubular component.

6. The positioning device of claim 2, wherein, A marking portion is provided on the main body portion for marking the circumferential fixing angle of the balloon in the accommodating chamber.

7. The positioning device of claim 6, wherein, The marking portion is a marking notch provided at the first end of the tubular component, and the marking notch can expose part of the surface area of the balloon.

8. The positioning device of claim 4, wherein, The positioning device comprises: an adapter portion in clamping connection with the main body portion.

9. The positioning device of claim 8, wherein, At least one pipe body section of the adapter portion is a straight pipe body.

10. The positioning device of claim 9, wherein, The positioning device comprises: a coaxial connecting portion, the adapter portion is connected with the main body portion through the coaxial connecting portion, and the coaxial connecting portion is used to keep the straight pipe body of the adapter portion and the straight pipe body of the main body portion share the same rotation axis.

11. A piercing system characterized by, The perforation system comprises: the positioning device according to any one of claims 1-10; a rotating device for driving the positioning device to rotate; a filling device for filling a balloon in the positioning device with a filling material; a perforation device for applying a perforation force to part of the surface area of the balloon exposed to the open unit holes of the positioning device.

12. A balloon perforation method characterized by, Based on the positioning device according to any one of claims 1-10 or the perforation system according to claim 11, comprising the following steps: placing a balloon into the accommodating chamber of the positioning device, fixing the balloon by using the fixing portion, and exposing the surface area of the balloon that needs to be perforated to the open unit holes of the positioning device; filling the balloon with a filling material, and applying a perforation force to the surface area of the balloon exposed to the open unit holes in the inflated state of the balloon.

13. The balloon perforation method of claim 12, wherein, comprising the following steps: discharging the filling material of the balloon, and taking out the balloon from the accommodating chamber of the positioning device; changing the angle of the balloon placed into the accommodating chamber, fixing the balloon by using the fixing portion, and exposing other surface area of the balloon that needs to be perforated to the open unit holes of the positioning device; The balloon is filled with a filling material, and a perforating force is applied to a surface area of the balloon exposed to the aperture cell holes in the inflated state of the balloon. The balloon is filled with a filling material, and a perforating force is applied to a surface area of the balloon exposed to the aperture cell holes in the inflated state of the balloon.

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