3D printing CRT / ICD local drug therapeutic apparatus and preparation method thereof

Abstract

The invention relates to a 3D printing CRT / ICD local drug therapeutic apparatus and a preparation method thereof. Hydrogel is arranged in a supporting device, the hydrogel is pressed on an incision through the supporting device, the supporting device is connected with a fixing device, and the supporting device is installed on an affected part through the fixing device; the hydrogel is made of polyacrylamide, is embedded with a drug carrier, and comprises an antibacterial drug and a procoagulant factor; the supporting piece is of a bowl-shaped structure generated based on the shape of an affected part and connected with the fixing device, an adjusting ring is arranged on the supporting piece and arranged on the adjusting rod in a sleeving mode, the adjusting rod stretches into the supporting piece, an arch pressing plate is arranged at the tail end of the adjusting rod, and the supporting piece is of a hollow structure generated based on the shape of an incision and filled with hydrogel. The affected part and the incision are scanned through the 3D printing technology, 3D data are reconstructed, and the supporting piece and the arch pressing plate are customized. Compared with the prior art, the hemostasis efficiency is greatly improved, the hemostasis time is shortened, and drug resistance and other side effects caused by systemic medication are avoided.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices and relates to a 3D printed CRT / ICD local drug therapy device and a preparation method thereof. Background Art

[0002] CRT / ICD (Cardiac Resynchronization Therapy / Implantable Cardioverter Defibrillator) is a conventional treatment for patients with heart failure and ventricular tachycardia, but the size and weight of the machine are three times that of an ordinary pacemaker. After implantation, a huge irregular mass forms on the surface of the wound, and the surgical incision is at the edge of the mass, so the wound is large, bleeding is heavy, it is easy to get infected, and the healing time is long. Since CRT / ICD is traumatic and prone to wound infection, routine intravenous antibiotics are required for 3-5 days after surgery. Antimicrobial drugs have a relatively poor antibacterial effect when they reach the local wound, and are prone to cause systemic drug-resistant bacteria. Especially for patients with pacemaker pocket infection, antibiotics will be used for a longer time, more than 1 month, which makes antibiotic resistance more serious.

[0003] In addition, the traditional sandbag compression method only compresses the center of the mass, cannot be customized according to the shape of the wound, and cannot directly compress the incision on the side, so the hemostasis effect is poor and the compression time is long. During the compression, the patient needs to lie flat for more than 8 hours, and if he is taking anticoagulant and antiplatelet drugs, it may even be extended to 10 hours, causing great discomfort and pain to the patient.

[0004] There are also literature reports on pacemaker compressors, but their core concept is just an improvement on sandbag compression, using air bags and silicone sheets instead of sandbags, which also have problems such as poor fit with the incision and low compression efficiency. Moreover, they cannot improve problems such as wound infection and bleeding after CRT / ICD surgery.

[0005] Patent CN206852710U discloses a foam dressing for postoperative care of cardiac pacemaker implantation. A fixing convex ring adapted to the pacemaker is provided in the middle of one side of the base layer. The fixing convex ring is made of hard sponge. A soft sponge layer is provided on the base layer inside the fixing convex ring. A hydrogel layer is provided on the outer surface of the fixing convex ring and the soft sponge layer. A medical pressure-sensitive adhesive is coated on the base layer outside the fixing convex ring. The middle part of the protective layer covers the hydrogel layer, and the surrounding parts are attached to the base layer with medical pressure-sensitive adhesive. Due to the large size of CRT / ICD and the irregular mass, the patent does not formulate an individualized fixing device for the mass, which will lead to poor fitting and only provide pressure perpendicular to the body surface, and cannot compress the side incision to provide lateral pressure; in addition, the patent does not have the ability to release drugs.

[0006] Patent CN111363171A discloses an antibacterial hydrogel and its preparation method and application. The hydrogel is obtained by chemically cross-linking hyaluronic acid with a cross-linking agent, and then after freeze-drying, a hydrogel powder with a relatively uniform particle size is obtained for the first time by grinding and passing through sieves of different diameters; then, the hyaluronic acid hydrogel powder is dissolved in PBS to obtain hyaluronic acid microspheres, which are mixed with polylysine solution in proportion. However, the hydrogel in this patent has low mechanical strength and cannot effectively transmit mechanical pressure to achieve physical compression of the wound.

[0007] Patent CN105286941A discloses an individualized 3D printed visceral hemostat and its manufacturing method, the individualized 3D printed visceral hemostat includes a hemostat body and a tightening belt, the hemostat body is a sheet-like soft body formed by 3D printing, its shape and size match the contour of the surgical site of the viscera, forming a close connection structure between the hemostat body and the surgical site of the viscera; the tightening belt is arranged on the hemostat body, and the hemostat body is fixed to the viscera by the contraction of the tightening belt, so that the hemostat body tightens or presses the viscera at the outer edge of the surgical site of the viscera, forming an individualized 3D printed visceral hemostatic structure for the visceral surgical resection site. However, the patent is directly fixed on the viscera, and for CRT / ICD, it is necessary to compress the wound surface after implantation to form a huge irregular mass. The weight of CRT / ICD itself is about 50g. After the patient sits up, the incision is not healed, which will cause the mass to fall. If only the tightening belt is used for compression, the supporting force is insufficient and it is difficult to lift the mass. Summary of the invention

[0008] The purpose of the present invention is to provide a 3D printed CRT / ICD local drug therapy device and a preparation method in order to overcome at least one defect of the above-mentioned prior art. The present invention greatly improves the hemostatic efficiency, shortens the hemostatic time, and avoids drug resistance and other side effects caused by systemic medication.

[0009] The purpose of the present invention can be achieved by the following technical solutions:

[0010] One of the technical solutions of the present invention is to provide a 3D printed CRT / ICD local drug therapy device, which includes a hydrogel, a supporting device and a fixing device. A surgical incision is made on the patient's skin at the edge of the affected part. The doctor implants a CRT / ICD (cardiac resynchronization therapy / implantable cardioverter defibrillator) under the affected part through the incision to form a skin bulge. The hydrogel is arranged in the supporting device, and the hydrogel is pressurized on the incision through the supporting device. The supporting device is connected to the fixing device, and the supporting device is installed on the affected part through the fixing device.

[0011] The material of the hydrogel is polyacrylamide (PAM), and a drug carrier is embedded in the hydrogel, and the drug carrier includes an antibacterial drug and a procoagulant factor;

[0012] The support device comprises a support member, an adjustment ring, an adjustment rod and an arch pressure plate. The support member adopts a bowl-shaped structure generated based on the shape of the affected part. The support member is connected to a fixing device. The support member is provided with an adjustment ring, which is sleeved on the adjustment rod. The adjustment rod extends into the support member. An arch pressure plate is provided at the end of the adjustment rod. The arch pressure plate adopts a hollow structure generated based on the shape of the incision. The arch pressure plate is filled with hydrogel to play a role in pressurization and drug treatment.

[0013] The affected area and incision are scanned through 3D printing technology, and the 3D data of the CRT / ICD protrusion and wound surface are reconstructed. Subsequently, the support parts and arch pressure plates are individually customized with the assistance of the 3D data modeling model. While achieving reliable fixation, it simplifies the manufacturing process, reduces production costs, and improves reliability.

[0014] As an inert polymer compound, polyacrylamide has low cytotoxicity when used in vitro;

[0015] Polyacrylamide has certain ductility and expansion force, and its shape is highly plastic. The material has good elasticity and can fit the surface of the incision tightly by applying pressure according to the various forms of the incision, and adapt to the shape of the arch plate. The network structure inside the polyacrylamide also allows the embedded drug carrier to be slowly released to the skin, ensuring that the drug can act directly on the target area, while enhancing the therapeutic effect and reducing the systemic reaction of the drug.

[0016] Polyacrylamide itself has a certain supporting force and can also play a role of physical compression. It can release drugs locally (incision) at the affected area to play an antibacterial and hemostatic role, avoiding the use of systemic antibiotics;

[0017] The storage modulus of polyacrylamide is similar to that of animal tissue and can be adjusted according to actual needs to reduce the damage to tissues caused by long-term compression.

[0018] As a preferred technical solution, a hydrogel notch is provided on the inner surface of the arch plate, and the hydrogel notch serves as a filling position for the hydrogel and a contact surface between the arch plate and the incision, thereby achieving precise local release of the drug.

[0019] Furthermore, the antibacterial drug is selected from one or more of silver sulfadiazine, penicillin G, amoxicillin, tetracycline, and levofloxacin, and the procoagulant factor is selected from one or more of fibrinogen, coagulation factor VIII concentrate, thrombin, and aminomethylbenzoic acid.

[0020] Furthermore, the support member adopts a spiral mesh hollow bowl-shaped structure, which is based on bionics and biomechanics. Through the mutual support between the grids, a multi-directional force-bearing spatial structure is formed. It has good integrity, high stability and increased spatial rigidity. While ensuring the supporting performance, it improves the patient's comfort, while reducing the use of materials, reducing production costs, and reducing the weight of the support member.

[0021] The use of printing technology and its materials can not only achieve the lightweight of the support device, but also reduce bleeding while ensuring maximum strength, while promoting the early implementation of rehabilitation activities; the support device based on 3D printing draws on the principles of human biomechanics and bionics to design its appearance, optimizes the local lightweight distribution, thereby achieving the purpose of extreme lightweighting of other support parts except for the parts for targeted incision treatment.

[0022] Furthermore, an internal thread is provided inside the adjustment ring, and an external thread is provided outside the adjustment rod. The adjustment ring and the adjustment rod cooperate with each other through threads to accurately position and fix the extension amount of the adjustment rod to ensure stability and accuracy, and control the distance from the arch pressure plate to the incision and the pressure intensity.

[0023] As a preferred technical solution, the position of the adjustment ring is customized according to the position of the cutout in cooperation with the adjustment rod.

[0024] As a preferred technical solution, the support member is provided with an ear slot, and the fixing device passes through the ear slot and is connected to the support member.

[0025] Furthermore, the fixing device includes a back tightening strap, a shoulder joint lifting strap, a first chest fixing strap and a second chest fixing strap. The back tightening strap and the two shoulder joint lifting straps cooperate to form a frame structure, and the fixing pressure is dispersed through the double shoulder joints, the upper chest wall and the chest and back, so as to strengthen the fixation of the support device and improve the stability. A first chest fixing strap is arranged between the two shoulder joint lifting straps, and a second chest fixing strap is arranged between the first chest fixing strap and the shoulder joint lifting strap. The second chest fixing strap is connected to the support member to fix the support device and apply a certain pressure.

[0026] As a preferred technical solution, the back tightening belt is tightened by a tightening piece, and the shoulder joint lifting belt is lifted by a lifting piece.

[0027] Furthermore, a supporting member is provided on the first chest fixing belt, and the supporting member supports the supporting member to prevent the supporting device from sinking due to gravity when the patient is sitting or standing.

[0028] As a preferred technical solution, one end of the two second chest fixing straps are respectively connected to the two ear seams, and the other ends are respectively connected to the first chest fixing strap and the shoulder joint lifting strap through connecting pieces.

[0029] One of the technical solutions of the present invention is to provide a method for preparing the 3D printed CRT / ICD local drug therapy device, the method comprising the following steps:

[0030] S1. Preparation of support device,

[0031] S1.1. Obtain scan data of the patient's chest CRT / ICD implant area;

[0032] S1.2. Perform three-dimensional modeling of the CRT / ICD implantation area based on the scan data;

[0033] S1.3. Draw the contour surface of the affected area and incision according to the three-dimensional model;

[0034] S1.4. Design the model of the support and the arch plate according to the contour surface of the affected area and the incision, and then customize the support and the arch plate with the help of the model;

[0035] S2. Hydrogel preparation,

[0036] S2.1, dissolving acrylamide in water at room temperature to obtain an acrylamide solution;

[0037] S2.2, adding antimicrobial drugs and procoagulant factors at room temperature;

[0038] S2.3, adding a crosslinking agent solution at room temperature;

[0039] S2.4, adding activator at room temperature;

[0040] S2.5, adding coagulant solution at room temperature;

[0041] S2.6, pouring the uncondensed solution into the mold;

[0042] S2.7, standing until the solution solidifies to obtain a hydrogel;

[0043] S2.8. Transfer the hydrogel to a supporting device.

[0044] By applying 3D printing technology to the medical field and combining it with engineering software such as CAD and CAM, we can print support devices that fully conform to the morphological contours of human bones and implants based on the patient's 3D scanning data and the patient's specific conditions and needs;

[0045] The customized support device based on 3D printing technology is customized according to the patient's body shape and the shape of the implant. It is designed as a support and an arch plate in combination with the position and shape of the implant. It can customize a fully matching support and an arch plate according to the patient's specific anatomical structure characteristics (contour surface). The arch plate is then tightly fitted to the surface of the incision through an adjustment rod. This highly personalized design can improve the matching degree between the support device and the human body, reduce the sense of inconsistency, and optimize the treatment effect.

[0046] 3D printing supports rapid adjustment and iteration, allowing the support device to be adjusted in time according to changes in the patient's condition. This flexibility enables the support device to better adapt to the treatment needs of different patients;

[0047] 3D printing allows precise control of material usage, reduces waste, and enables the manufacture of lightweight support devices, which not only reduces production costs but also reduces the burden on patients when wearing them and improves comfort.

[0048] Hydrogels are simple to prepare and can be made by mixing several substances at room temperature.

[0049] As a preferred technical solution, in step S1.3, the three-dimensional model data after modeling is preprocessed, including: smoothing, removing noise points, and simplifying the model.

[0050] Furthermore, the design method of the model of the support member and the arch plate in step S1.4 includes the following steps:

[0051] Extract the contour surface according to the shape of the affected area, expand the contour surface outward by 3-5cm to form the reference surface of the support, and finally thicken the reference surface evenly on both sides to form a support with a thickness of 1-3mm;

[0052] The exact position of the arch pressure plate is determined based on the incision position, and the contour surface is extracted according to the incision shape, and the contour surface is expanded outward by 1-3mm to form the arch pressure plate.

[0053] As a preferred technical solution, in step S1.4, a circular ring with a diameter of 1-3 cm is taken at the middle position based on the size of the arch pressure plate and stretched outward to form an adjustment rod.

[0054] Furthermore, in step S2.3, the cross-linking agent is methylene bisacrylamide;

[0055] In step S2.4, the activator is tetramethylethylenediamine;

[0056] In step S2.5, ammonium sulfate is used as the coagulant.

[0057] Further, the concentration of the acrylamide solution in step S2.1 is 1-20%;

[0058] The total mass of the antimicrobial drug and the procoagulant factor added in step S2.2 is 0.001-0.1% of the mass of the acrylamide solution;

[0059] In step S2.3, the volume ratio of the crosslinking agent solution to the acrylamide solution is 1:(1-20), and the final concentration of the crosslinking agent in the acrylamide solution is 0.01-1%;

[0060] The volume of the activator in step S2.4 is 0.001-0.002% of the volume of the acrylamide solution;

[0061] The concentration of the coagulant solution in step S2.5 is 1-15%, and the final concentration of the coagulant in the acrylamide solution is 0.01-0.1%;

[0062] The standing time in step S2.7 is 20-120 min.

[0063] One of the technical solutions of the present invention is to provide a 3D printed CRT / ICD local drug treatment method, which uses the therapeutic device to treat the incision after implantation of CRT / ICD, and the method comprises the following steps:

[0064] Align the arch pressure plate with the incision, fit the support piece with the affected area, fix the support piece to the patient through the second chest fixing belt, pass the shoulder joint lifting belt through the shoulder and the back tightening belt to connect with the patient's back to ensure that the support device is firmly fixed to the patient and does not move. At the same time, turn the adjustment ring to drive the adjustment rod to rotate, so as to drive the arch pressure plate to move up and down, fit the arch pressure plate with the incision, and achieve precise compression and hemostasis of the incision;

[0065] Before compression hemostasis, the hydrogel is injected into the arch plate of the hollow structure. The hydrogel contacts the incision, plays a role in physical compression and release of antibacterial drugs to stop hemorrhage, improves hemostasis efficiency, shortens hemostasis time, and avoids drug resistance and other side effects caused by systemic medication.

[0066] Compared with the prior art, the present invention has the following beneficial effects:

[0067] (1) The present invention uses polyacrylamide to embed drug carriers to accurately transport drugs to the incision site, play an antibacterial, anti-inflammatory, hemostatic and anticoagulant role, and avoid drug resistance and other side effects caused by systemic medication;

[0068] (2) The present invention uses 3D printing technology to individually customize a support device that meets the size, shape, protrusion characteristics, and incision position of the affected area, effectively solving the problem that the previous sandbag compression cannot fit the surface and completely compresses the incision, greatly improving the hemostasis efficiency and shortening the hemostasis time;

[0069] (3) The present invention uses a back tightening belt, a shoulder joint lifting belt, a chest fixing belt, a supporting member and other fixing devices to fix the supporting device, which does not affect the movement of both upper limbs. At the same time, the patient can sit or stand for treatment after surgery to avoid lying flat for a long time, which will greatly improve the comfort of treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0070] Figure 1 This is a schematic diagram of the structure of a 3D printed CRT / ICD local drug therapy device in an embodiment of the present invention;

[0071] Figure 2 This is a schematic diagram of the front structure of the supporting device in an embodiment of the present invention;

[0072] Figure 3 This is a schematic diagram of the back structure of the supporting device in an embodiment of the present invention;

[0073] Figure 4 It is a schematic diagram of the pressurization of the arch pressure plate and the incision of the first CRT / ICD implant shape in the embodiment of the present invention;

[0074] Figure 5 Schematic diagram of the pressurization of the arch pressure plate and the incision of the second CRT / ICD implant shape in the embodiment of the present invention;

[0075] Figure 6 Schematic diagram of the compression of the arch plate and the incision of the third CRT / ICD implant shape in the embodiment of the present invention.

[0076] Description of the markings in the figure:

[0077] 1—hydrogel, 2—support device, 3—fixation device, 4—skin;

[0078] 21—supporting member, 211—ear seam, 22—adjusting ring, 23—adjusting rod, 24—arch pressure plate, 241—hydrogel notch;

[0079] 31 - back tightening belt, 32 - shoulder joint lifting belt, 33 - first chest fixing belt, 34 - supporting member, 35 - second chest fixing belt;

[0080] 41—affected area, 42—incision. DETAILED DESCRIPTION

[0081] The present invention is described in detail below in conjunction with specific embodiments. This embodiment is implemented based on the technical solution of the present invention, and provides a detailed implementation method and a specific operation process, but the protection scope of the present invention is not limited to the following embodiments.

[0082] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inside", "outside", etc. indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, which are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. In addition, the terms "first", "second", "third", etc. are used to describe common objects, which only refer to different instances of the same object, and are not intended to imply that the objects described in this way must adopt a given order, whether in time, space, order or any other way.

[0083] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0084] Unless otherwise specified, the equipment used in the following examples are all conventional equipment in the art; the reagents used are all commercially available products or prepared by conventional methods in the art unless otherwise specified. Anything not described in detail in the following examples can be achieved by conventional experimental means in the art.

[0085] Example:

[0086] A 3D printed CRT / ICD local drug therapy device comprises a hydrogel 1, a support device 2 and a fixing device 3. A surgical incision 42 is opened on the patient's skin 4 at the edge of an affected part 41. A doctor implants a CRT / ICD (cardiac resynchronization therapy / implantable cardioverter defibrillator) under the affected part 41 through the incision 42 to form a skin bulge. The hydrogel 1 is arranged in the support device 2. The hydrogel 1 is pressurized on the incision 42 through the support device 2. The support device 2 is connected to the fixing device 3. The support device 2 is installed on the affected part 41 through the fixing device 3.

[0087] The material of the hydrogel 1 is polyacrylamide (PAM), and the hydrogel 1 is embedded with a drug carrier, which includes an antibacterial drug and a procoagulant factor;

[0088] As an inert polymer compound, polyacrylamide has low cytotoxicity when used in vitro;

[0089] Polyacrylamide has certain ductility and expansion force, and its shape is highly plastic. The material has good elasticity and can be closely fitted to the surface of the incision 42 by applying pressure according to various forms of the incision 42, and is adapted to the shape of the arch plate 24. The network structure inside the polyacrylamide also allows the embedded drug carrier to be slowly released onto the skin 4, ensuring that the drug can directly act on the target area, while enhancing the therapeutic effect and reducing the systemic reaction of the drug.

[0090] Polyacrylamide itself has a certain supporting force and can also play a role of physical compression, and can release drugs locally (incision 42) at the affected area 41 to play an antibacterial and hemostatic role, thus avoiding the use of antibiotics throughout the body;

[0091] The storage modulus of polyacrylamide is similar to that of animal tissues and can be adjusted according to actual needs to reduce the damage to tissues caused by long-term compression;

[0092] Silver sulfadiazine was selected as the antibacterial drug, and fibrinogen was selected as the procoagulant factor;

[0093] like Figure 2 and Figure 3 As shown, the support device 2 includes a support member 21, an adjustment ring 22, an adjustment rod 23 and an arch plate 24. The support member 21 adopts a bowl-shaped structure generated based on the shape of the affected part 41. The support member 21 is connected to the fixing device 3. The support member 21 is provided with an adjustment ring 22, which is sleeved on the adjustment rod 23. The adjustment rod 23 extends into the support member 21, and an arch plate 24 is provided at the end of the adjustment rod 23. The arch plate 24 adopts a hollow structure generated based on the shape of the incision 42. The arch plate 24 is filled with hydrogel 1 to play a role in pressurization and drug treatment. The inner surface of the arch plate 24 is provided with a hydrogel notch 241. The hydrogel notch 241 serves as the filling position of the hydrogel 1 and the surface of the arch plate 24 in contact with the incision 42, so as to realize the local and precise release of the drug.

[0094] The affected part 41 and the incision 42 are scanned by 3D printing technology to reconstruct the 3D data of the CRT / ICD protrusion and the wound surface, and then the support member 21 and the arch plate 24 are individually customized with the aid of the 3D data modeling model, which simplifies the manufacturing process, reduces the production cost, and improves the reliability while achieving reliable fixation;

[0095] The support member 21 adopts a spiral mesh hollow bowl-shaped structure, based on bionics and biomechanics, and forms a multi-directional force-bearing space structure through mutual support between grids, which has good integrity, high stability and increased spatial rigidity. While ensuring the supporting performance, it improves the patient's comfort, reduces the use of materials, reduces the production cost, and reduces the weight of the support member 21;

[0096] The use of printing technology and materials can not only achieve lightweighting of the support device 2, but also reduce bleeding while ensuring maximum strength, and promote the early implementation of rehabilitation activities; the support device 2 based on 3D printing draws on the principles of human biomechanics and bionics to design its appearance and optimizes the local lightweight distribution, thereby achieving the purpose of extreme lightweighting of other supporting parts in addition to the parts for targeted treatment of the incision 42;

[0097] The adjusting ring 22 is provided with an internal thread, and the adjusting rod 23 is provided with an external thread. The adjusting ring 22 and the adjusting rod 23 cooperate with each other through threads to accurately position and fix the extension amount of the adjusting rod 23, so as to ensure stability and accuracy, and control the distance from the arch plate 24 to the cutout 42 and the pressure.

[0098] The position of the adjustment ring 22 is customized according to the position of the cutout 42 in cooperation with the adjustment rod 23;

[0099] The support member 21 is provided with two ear slots 211, and the fixing device 3 passes through the ear slots 211 and is connected to the support member 21;

[0100] like Figure 1 As shown, the fixing device 3 includes a back tightening belt 31, a shoulder joint lifting belt 32, a first chest fixing belt 33 and a second chest fixing belt 35. The back tightening belt 31 and the two shoulder joint lifting belts 32 cooperate to form a frame structure, and the fixing pressure is dispersed through the double shoulder joints, the upper chest wall and the chest and back to strengthen the fixation of the support device 2 and improve the stability. The first chest fixing belt 33 is arranged between the two shoulder joint lifting belts 32, and the second chest fixing belt 35 is arranged between the first chest fixing belt 33 and the left shoulder joint lifting belt 32. The second chest fixing belt 35 is connected to the support member 21 to fix the support device 2 and apply a certain pressure.

[0101] The back tightening belt 31 is tightened by the tightening member, and the shoulder joint lifting belt 32 is lifted by the lifting member;

[0102] A supporting member 34 is provided on the left side of the first chest fixing belt 33, and the supporting member 34 supports the supporting member 21 to prevent the supporting device 2 from sinking due to gravity when the patient is sitting or standing;

[0103] One ends of the two second chest fixing straps 35 are respectively connected to the two ear slits 211 , and the other ends are respectively connected to the first chest fixing strap 33 and the left shoulder joint lifting strap 32 through connecting pieces.

[0104] In this embodiment, the tightening member and the pulling member are made of Velcro.

[0105] The preparation method of the above 3D printed CRT / ICD local drug therapy device has the following specific steps:

[0106] S1. Preparation of support device 2,

[0107] S1.1. Obtain CT scan data of the patient's chest CRT / ICD implantation area and body surface scan data;

[0108] S1.2. Based on the CT scan data and body surface scan data, use 3D numerical modeling software to perform 3D modeling of the CRT / ICD implantation area;

[0109] S1.3, preprocessing the three-dimensional model data after modeling, including: smoothing, removing noise and clutter points, and simplifying the model; then drawing the contour surfaces of the affected part 41 and the incision 42 according to the preprocessed three-dimensional model, and saving the file in iges format;

[0110] S1.4, according to the contour surface of the affected part 41 and the incision 42, the model of the support member 21 and the arch plate 24 is designed using a three-dimensional numerical model software, and a three-dimensional model data file is obtained, and then the support member 21 and the arch plate 24 are individually customized with the aid of the model;

[0111] The specific steps of the design method of the model of the support member 21 and the arch pressure plate 24 are as follows:

[0112] The contour surface is extracted according to the shape of the affected part 41, and the contour surface is extended outward by 4 cm to form a reference surface of the support member 21. Finally, the reference surface is evenly thickened on both sides to form a support member 21 with a thickness of 2 mm.

[0113] The accurate position of the arching plate 24 is determined based on the position of the cutout 42, and the contour surface is extracted according to the shape of the cutout 42, and the contour surface is expanded outward by 2 mm to form the arching plate 24;

[0114] Based on the size of the arch plate 24, a 2 cm diameter ring is taken at the middle position and stretched outward to form an adjustment rod 23;

[0115] By applying 3D printing technology to the medical field and combining it with engineering software such as CAD and CAM, we can print support devices that fully conform to the morphological contours of human bones and implants based on the patient's 3D scan data and according to the patient's specific conditions and needs2;

[0116] The customized support device 2 based on 3D printing technology is customized according to the patient's body shape and the shape of the implant, and is designed as a support member 21 and an arch plate 24 in combination with the position and shape of the implant. Figure 4 As shown, if the protrusion of the affected part 41 is relatively flat, the incision 42 is located at the inner edge of the affected part 41 closer to the skin 4, or, as shown in FIG. Figure 5 As shown, even if the protrusion of the affected part 41 is relatively prominent and the incision 42 is located at the relatively exposed edge of the affected part 41, as shown in FIG. Figure 6 As shown, even if the connection between the protrusion of the affected part 41 and the skin 4 is significantly narrower than the entire CRT / ICD, and the incision 42 is located at the concave edge of the affected part 41 very close to the skin 4, a fully matching support member 21 and arch plate 24 can be customized according to the specific anatomical structure characteristics (contour surface) of the patient, and then the arch plate 24 is tightly fitted to the surface of the incision 42 through the adjustment rod 23. This highly personalized design can improve the matching degree between the support device 2 and the human body, reduce the sense of inconsistency, and optimize the treatment effect;

[0117] 3D printing supports rapid adjustment and iteration, so that the support device 2 can be adjusted in time according to changes in the patient's condition. This flexibility enables the support device 2 to better adapt to the treatment needs of different patients;

[0118] 3D printing allows precise control of material usage, reduces waste, and enables the manufacture of lightweight support devices2, which not only reduces production costs, but also reduces the burden on patients when wearing them and improves comfort;

[0119] S2. Preparation of hydrogel 1,

[0120] S2.1, dissolving acrylamide in deionized water at room temperature to obtain a 10% acrylamide solution;

[0121] S2.2, add silver sulfadiazine and fibrinogen powder at room temperature, the added mass of the powder is 0.005% of the mass of the acrylamide solution;

[0122] S2.3, adding methylene bisacrylamide solution at a volume ratio of 1:10 at room temperature, and the final concentration of methylene bisacrylamide in the acrylamide solution is 0.1%;

[0123] S2.4, adding tetramethylethylenediamine at room temperature, the volume of tetramethylethylenediamine being 0.0015% of the volume of the acrylamide solution;

[0124] S2.5, add 10% ammonium sulfate solution at room temperature, the final concentration of ammonium sulfate in the acrylamide solution is 0.05%;

[0125] S2.6, pouring the uncondensed solution into the mold;

[0126] S2.7, standing for 30 min until the solution solidifies to obtain hydrogel 1;

[0127] S2.8, transferring the hydrogel 1 to the supporting device 2;

[0128] The preparation of hydrogel 1 is simple and can be prepared by mixing several substances at room temperature.

[0129] A 3D printed CRT / ICD local drug treatment method, using the above-mentioned treatment device to treat the incision 42 after implantation of CRT / ICD, the specific steps are as follows:

[0130] When in use, the medical staff or caregiver can align the arch plate 24 with the incision 42, fit the support member 21 with the affected part 41, fix the support member 21 on the patient through the two second chest fixing belts 35, and connect the shoulder joint lifting belt 32 through the shoulder and the back tightening belt 31 at the back of the patient to ensure that the support device 2 is firmly fixed on the patient and does not move. At the same time, the adjustment ring 22 is turned to drive the adjustment rod 23 to rotate, so as to drive the arch plate 24 to move up and down, fit the arch plate 24 with the incision 42, and achieve accurate compression and hemostasis of the incision 42;

[0131] Before performing compression hemostasis, the hydrogel 1 can be injected into the hollow structure arch plate 24. The hydrogel 1 contacts the incision 42, which plays a role of physical compression and release of antibacterial drugs for hemostasis, thereby improving hemostasis efficiency, shortening hemostasis time, and avoiding drug resistance and other side effects caused by systemic medication.

[0132] The bowl-shaped structure support member 21 generated based on the shape of the affected part 41 of the present invention is basically the same as the shape of the CRT / ICD implant, which can minimize the impact on the patient's daily life and relieve the patient's postoperative psychological stress. Different numbers of holes are arranged on the surface of the support member 21, which greatly reduces the weight and has better air permeability, greatly improving the patient's comfort. The hollow structure arch pressure plate 24 generated based on the shape of the incision 42 is basically the same as the wound shape, reducing pressure on other parts. At the same time, the design of the hydrogel 1 can more effectively improve the hemostasis efficiency, shorten the hemostasis time, and avoid drug resistance and other side effects caused by systemic medication.

[0133] The above description of the embodiments is to facilitate the understanding and use of the invention by those skilled in the art. It is obvious that those skilled in the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative work. Therefore, the present invention is not limited to the above embodiments, and improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the present invention should be within the scope of protection of the present invention.

Claims

1. A 3D printed CRT / ICD local drug therapy device, characterized in that: The therapeutic device comprises a hydrogel (1), a supporting device (2) and a fixing device (3); a surgical incision (42) is opened on the patient's skin (4) at the edge of an affected part (41); a doctor implants a CRT / ICD under the affected part (41) through the incision (42) to form a skin bulge; the hydrogel (1) is arranged in the supporting device (2); the hydrogel (1) is pressurized on the incision (42) through the supporting device (2); the supporting device (2) is connected to the fixing device (3); and the supporting device (2) is installed on the affected part (41) through the fixing device (3); The material of the hydrogel (1) is polyacrylamide, and a drug carrier is embedded in the hydrogel (1), and the drug carrier includes an antibacterial drug and a procoagulant factor; The support device (2) comprises a support member (21), an adjustment ring (22), an adjustment rod (23) and an arch pressure plate (24); the support member (21) adopts a bowl-shaped structure generated based on the shape of the affected part (41); the support member (21) is connected to the fixing device (3); an adjustment ring (22) is provided on the support member (21); the adjustment ring (22) is sleeved on the adjustment rod (23); the adjustment rod (23) extends into the support member (21); an arch pressure plate (24) is provided at the end of the adjustment rod (23); the arch pressure plate (24) adopts a hollow structure generated based on the shape of the incision (42); and the arch pressure plate (24) is filled with hydrogel (1); The affected area (41) and the incision (42) are scanned by 3D printing technology to reconstruct the 3D data of the CRT / ICD protrusion and the wound surface, and then the support (21) and the arch pressure plate (24) are customized with the assistance of the 3D data modeling model.

2. A 3D printed CRT / ICD local drug therapy device according to claim 1, characterized in that: The antibacterial drug is selected from one or more of silver sulfadiazine, penicillin G, amoxicillin, tetracycline, and levofloxacin, and the procoagulant factor is selected from one or more of fibrinogen, coagulation factor VIII concentrate, thrombin, and aminomethylbenzoic acid.

3. A 3D printed CRT / ICD local drug therapy device according to claim 1, characterized in that: The support member (21) adopts a spiral mesh hollow bowl-shaped structure.

4. A 3D printed CRT / ICD local drug therapy device according to claim 1, characterized in that: The adjusting ring (22) is provided with an internal thread, the adjusting rod (23) is provided with an external thread, and the adjusting ring (22) and the adjusting rod (23) are matched with each other through threads.

5. A 3D printed CRT / ICD local drug therapy device according to claim 1, characterized in that: The fixing device (3) comprises a back tightening belt (31), a shoulder joint lifting belt (32), a first chest fixing belt (33) and a second chest fixing belt (35); the back tightening belt (31) and the two shoulder joint lifting belts (32) cooperate to form a frame structure; a first chest fixing belt (33) is arranged between the two shoulder joint lifting belts (32); a second chest fixing belt (35) is arranged between the first chest fixing belt (33) and the shoulder joint lifting belt (32); and the second chest fixing belt (35) is connected to the support member (21) via the second chest fixing belt (35).

6. A 3D printed CRT / ICD local drug therapy device according to claim 5, characterized in that: A supporting member (34) is provided on the first chest fixing belt (33), and the supporting member (34) supports the supporting member (21).

7. A method for preparing a 3D printed CRT / ICD local drug therapy device as claimed in any one of claims 1 to 6, characterized in that: The method comprises the following steps: S1. Preparation of supporting device (2), S1.

1. Obtain scan data of the patient's chest CRT / ICD implant area; S1.

2. Perform three-dimensional modeling of the CRT / ICD implantation area based on the scan data; S1.3, drawing the contour surfaces of the affected area (41) and the incision (42) according to the three-dimensional model; S1.4, designing a model of the support member (21) and the arch pressure plate (24) according to the contour surface of the affected part (41) and the incision (42), and then customizing the support member (21) and the arch pressure plate (24) with the aid of the model; S2. Preparation of hydrogel (1), S2.1, dissolving acrylamide in water at room temperature to obtain an acrylamide solution; S2.2, adding antimicrobial drugs and procoagulant factors at room temperature; S2.3, adding a crosslinking agent solution at room temperature; S2.4, adding activator at room temperature; S2.5, adding coagulant solution at room temperature; S2.6, pouring the uncondensed solution into the mold; S2.7, allowing the solution to solidify to obtain a hydrogel (1); S2.

8. Transfer the hydrogel (1) to the supporting device (2).

8. The method for preparing a 3D printed CRT / ICD local drug therapy device according to claim 7, characterized in that: The design method of the model of the support member (21) and the arch pressure plate (24) in step S1.4 comprises the following steps: Extract a contour surface according to the shape of the affected part (41), expand the contour surface outward by 3-5 cm to form a reference surface of the support member (21), and finally thicken the reference surface inwardly and outwardly to form a support member (21) with a thickness of 1-3 mm; The orientation of the arching plate (24) is determined based on the position of the incision (42), and the contour surface is extracted according to the shape of the incision (42), and the contour surface is expanded outward by 1-3 mm to form the arching plate (24).

9. The method for preparing a 3D printed CRT / ICD local drug therapy device according to claim 7, characterized in that: In step S2.3, the cross-linking agent is methylene bisacrylamide; In step S2.4, the activator is tetramethylethylenediamine; In step S2.5, ammonium sulfate is used as the coagulant.

10. The method for preparing a 3D printed CRT / ICD local drug therapy device according to claim 7, characterized in that: The concentration of the acrylamide solution in step S2.1 is 1-20%; The total mass of the antimicrobial drug and the procoagulant factor added in step S2.2 is 0.001-0.1% of the mass of the acrylamide solution; In step S2.3, the volume ratio of the crosslinking agent solution to the acrylamide solution is 1:(1-20), and the final concentration of the crosslinking agent in the acrylamide solution is 0.01-1%; The volume of the activator in step S2.4 is 0.001-0.002% of the volume of the acrylamide solution; The concentration of the coagulant solution in step S2.5 is 1-15%, and the final concentration of the coagulant in the acrylamide solution is 0.01-0.1%; The standing time in step S2.7 is 20-120 min.

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