Pacemaker intraoperative pulse generator electrode wire fixing device

Abstract

The utility model relates to the technical field of medical equipment, in particular to a pulse generator electrode wire fixing device in a pacemaker operation. Comprising an elastic band sleeved on a pulse generator; the electrode wire wrapping part is arranged on the back surface of the pulse generator and is connected with the two ends of the elastic band; the wire coiling part is arranged on the electrode wire wrapping part; the wire winding part is suitable for winding an electrode wire of the pulse generator, and the electrode wire wrapping part is suitable for fixing the electrode wire wound on the wire winding part. The disc can serve as an acting point of an operator, the electrode wire can be wound conveniently, the two electrode wire buckles can be bent after winding is completed, the electrode wire buckles and the fixing arms are made to press the wound electrode wire, and the electrode wire is pressed and fixed to the transverse bridge in a disc shape.

Description

Technical Field

[0001] The utility model relates to the technical field of medical equipment, in particular to a device for fixing an electrode line of a pulse generator during a pacemaker operation. Background Art

[0002] During the implantation of a permanent pacemaker, the pulse generator needs to be placed in the pouch and the electrode wire needs to be placed on the back of the pulse generator. The existing method of handling the electrode wire is to coil the electrode wire directly on the back of the pulse generator. However, when using this method, since the electrode wire is placed on the back of the pulse generator and the space in the pouch is limited, it is impossible to coil it directly. The surgeon has certain difficulty in coiling it, which affects the efficiency and quality of the operation. In addition, the electrode wire coiled in this way is easy to be freed from the pulse generator, which may lead to the risk of failure of the operation. Utility Model Content

[0003] Therefore, the purpose of the utility model is to provide an auxiliary device for electrode coiling in order to make the electrode wire more firmly coiled behind the pulse generator during permanent pacemaker implantation and to improve the efficiency and quality of the coiling operation by the operator.

[0004] The utility model provides a device for fixing an electrode line of a pulse generator during a pacemaker operation, comprising:

[0005] An elastic band, which is mounted on the pulse generator;

[0006] The electrode wire wrapping part is arranged on the back of the pulse generator and connected to the two ends of the elastic band;

[0007] A wire coiling portion, arranged on the electrode wire wrapping portion;

[0008] The wire coiling portion is suitable for winding the electrode wire of the pulse generator, and the electrode wire wrapping portion is suitable for fixing the electrode wire wound on the wire coiling portion.

[0009] Furthermore, a plurality of striped protrusions are provided on a side of the elastic band close to the pulse generator.

[0010] Furthermore, the electrode wire wrapping portion includes:

[0011] The cross bridge is attached to the back of the pulse generator, and the two ends of the cross bridge are respectively connected to the two ends of the elastic band. The pulse generator is set in the ring structure formed by the cross bridge and the elastic band.

[0012] Furthermore, the cross bridge does not protrude from the side of the pulse generator.

[0013] Furthermore, the electrode wire wrapping portion further includes:

[0014] There are two electrode wire buckles, which are respectively arranged on two end sides of the cross bridge.

[0015] Furthermore, the electrode wire buckle is made of soft metal.

[0016] Furthermore, the electrode wire wrapping portion further includes:

[0017] There are two fixed arms, which are arranged on one end of the electrode line buckle away from the cross bridge and correspond one to one with the electrode line buckle. The fixed arms are fan-shaped.

[0018] Furthermore, the electrode wire wrapping portion further includes:

[0019] The silicone layer, the fixing arm is wrapped and arranged on the inner side of the silicone layer.

[0020] Furthermore, the wire coiling unit includes:

[0021] A first support column, one end of which is connected to the cross bridge, and the length of the first support column is not greater than the diameter of the electrode wire;

[0022] A second support column, one end of which is connected to an end of the first support column away from the cross bridge through a splicing assembly;

[0023] A disc, arranged on an end of the second support column away from the first support column;

[0024] The first support column, the second support column, the splicing component and the disc are all made of silicone.

[0025] Furthermore, the splicing assembly includes:

[0026] A stitching ball, arranged on one end of the first support column close to the second support column;

[0027] The splicing groove is arranged on one end of the second supporting column close to the first supporting column, and the splicing groove, the splicing ball and the splicing groove are connected by a ball head.

[0028] The technical solution of the utility model has the following advantages:

[0029] The utility model provides a pacemaker intraoperative pulse generator electrode wire fixing device. After the electrode is placed in the correct position, part of the electrode wire can be wound outside the patient's body. At this time, the first support column and the second support column are connected together, and the electrode wire is wound around the first support column and the second support column. Since the back of the pulse generator faces away from the intraoperative field of view, the disc can be used as a fulcrum for the operator. After winding, the disc can be pulled to take out the disc and the second support column, reducing the possibility of infection in the pouch after surgery. Then, the two electrode wire buckles are bent so that the electrode wire buckle and the fixing arm are pressed on the wound electrode wire, and the electrode wire is pressed and fixed on the cross bridge in a disc-shaped manner, and finally set in the pouch. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the specific implementation methods of the utility model or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0031] Figure 1 It is a schematic diagram of the structure of the utility model;

[0032] Figure 2 This is a schematic diagram of the structure when the first support column and the second support column of the utility model are separated;

[0033] Figure 3 This is a schematic diagram of the relative positions of the fixed arm and the silicone layer of the utility model;

[0034] Figure 4 The number and growth rate of pacemaker implants in China from 2016 to 2022.

[0035] Description of reference numerals;

[0036] 1. Elastic band; 2. Pulse generator; 3. Cross bridge; 4. Electrode wire buckle; 5. Fixed arm; 6. Silicone layer; 7. First support column; 8. Second support column; 9. Disc; 10. Splicing ball; 11. Splicing groove. DETAILED DESCRIPTION

[0037] The technical solution of the utility model will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments of the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0038] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying 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 limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0039] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installation", "connection" and "connection" 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.

[0040] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0041] Example

[0042] Bradyarrhythmia is the terminal stage of various heart diseases. According to the "Chinese Expert Consensus on the Evaluation and Management of Patients with Bradycardia and Conduction Abnormalities 2020", the incidence of bradycardia in my country is as high as 1% in people over 65 years old. Permanent pacemakers are currently the only effective means of treating bradycardia. According to the "2023-2029 China Cardiac Pacemaker Industry Panoramic Survey and Investment Prospect Assessment Report", about 1 million permanent pacemakers are implanted each year in the world. In 2022, the number of permanent pacemakers implanted in my country was 99,000, and the number increased by 10-15% each year. Figure 4 shown.

[0043] Compared with coronary stent surgery, the biggest difference between permanent pacemaker implantation surgery and coronary stent surgery is that there is a foreign body left on the body surface after surgery, so how to minimize the foreign body sensation is an important guarantee for the patient's quality of life after surgery. Patients with pacemaker implantation have a pouch on the chest wall under their clavicle, which is generally made between the muscle layer and deep fascia of the pectoralis major muscle (some are made shallower between the deep and superficial fascia). This pouch contains a complete set of pacing devices, including pulse generators, electrodes and sutures to fix them. Among these three, the electrode wire is mobile. One (single-chamber pacemaker) or two (dual-chamber pacemaker) electrodes of 52-63 cm are fixed on the myocardium at one end and fixed on the pulse generator at the other end by screws. The electrode wire in the middle of about 20 cm has no support and is only "stuffed" under the pulse generator by the surgeon. In the implantation of permanent pacemakers, it is of great significance that the electrode wire can be properly coiled under the pulse generator and kept from being freed from the pulse generator in the future. First, during the operation, if the electrode wire is free from the pulse generator, it will interfere with the suture field of view, and it will also cause the electrode implanted in the heart cavity to shift and dislocate due to the traction of the electrode in the pocket, resulting in failure of the operation. Secondly, if the electrode wire is free from the pulse generator to the subcutaneous part in the future, the patient will see the outline of the electrode on the surface of the body, which may cause panic and affect the quality of life. In severe cases, the friction between the electrode and the skin during upper limb activities may cause the pocket to be damaged, causing infection and eventually leading to the removal of the entire pacing system from the body and re-implantation on the opposite side. Third, the pacemaker is a battery-consuming implantable device. At present, the pulse generator with the largest power needs to be replaced once every 10 years or so. That is to say, basically all pacemaker patients have to undergo 1-2 replacement operations in their lifetime. If the electrode cannot be stably and completely "hidden" under the pulse generator, it is easy to damage the electrode when the skin is cut and the pocket is separated during the replacement operation, and the electrode in the heart cavity may be dislocated due to the traction of the external segment electrode. In summary, the stable coiling of the electrode wire during the first surgery is one of the most important operating steps. However, the coiling of the electrode wire is usually performed behind the pulse generator and cannot be performed under direct vision. In addition, the space in the capsular bag is relatively limited, only two fingers can enter for operation, so the coiling of the electrode wire is somewhat difficult.

[0044] like Figures 1 to 3 A specific embodiment of a device for fixing a pulse generator electrode wire during a pacemaker operation is shown, and the device for fixing a pulse generator electrode wire during a pacemaker operation comprises:

[0045] The elastic band 1 is mounted on the pulse generator 2, wherein the elastic band 1 should be suitable for various types and sizes of pulse generators 2 produced by different companies. When not installed, the elastic band 1 is in a relaxed state, and after being stretched, the elastic band 1 can be tightly tied to the pulse generator 2. The material of the elastic band 1 can be natural fiber, thermoplastic polyurethane rubber, etc., and the present embodiment is not limited thereto.

[0046] The electrode wire wrapping portion is arranged on the back of the pulse generator 2 and connected to the two ends of the elastic band 1, wherein the back of the pulse generator 2 faces away from the intraoperative field of view. This is because when winding the electrode wire, the back of the pulse generator 2 is turned over first, and then turned over again after winding is completed, which will cause the electrode wire to be pulled more significantly. Therefore, when winding the electrode wire, the back of the pulse generator 2 needs to face away from the intraoperative field of view.

[0047] A wire coiling portion, arranged on the electrode wire wrapping portion;

[0048] The wire coiling portion is suitable for winding the electrode wire of the pulse generator 2, and the electrode wire wrapping portion is suitable for fixing the electrode wire wound on the wire coiling portion.

[0049] Furthermore, a plurality of stripe protrusions are provided on one side of the elastic band 1 close to the pulse generator 2. The stripe protrusions can increase the friction between the elastic band 1 and the pulse generator 2 to strengthen the fixing effect of the elastic band 1.

[0050] Furthermore, the electrode wire wrapping portion includes:

[0051] The cross bridge 3 is attached to the back of the pulse generator 2, and the two ends of the cross bridge 3 are respectively connected to the two ends of the elastic band 1, and the pulse generator 2 is set in the ring structure formed by the cross bridge 3 and the elastic band 1. Among them, the cross bridge 3 can be made of an alloy material with relatively high strength.

[0052] Furthermore, the cross bridge 3 does not protrude from the side of the pulse generator 2. At the same time, the length of the cross bridge 3 should be shorter than the short diameter of the smallest pulse generator 2 on the market, which can prevent the cross bridge 3 from protruding from the pulse generator 2 and puncturing the capsule.

[0053] Furthermore, the electrode wire wrapping portion further includes:

[0054] There are two electrode wire buckles 4, which are respectively arranged at two end sides of the cross bridge 3. The cross bridge 3 and the electrode wire buckles 4 at both ends can be integrally formed.

[0055] Furthermore, the electrode wire buckle 4 is made of a soft metal material. The soft metal material has good plasticity, such as titanium alloy or titanium and other metals, and the electrode wire buckle 4 can be bent to apply pressure to the coiled electrode wire to achieve the purpose of fixing the electrode wire.

[0056] Furthermore, the electrode wire wrapping portion further includes:

[0057] There are two fixing arms 5, which are arranged on the end of the electrode wire buckle 4 away from the cross bridge 3, and correspond to the electrode wire buckle 4 one by one. The fixing arms 5 are fan-shaped, and the electrode wire buckle 4 and the fixing arms 5 are suitable for pressing the electrode wire wound on the coiling part on the cross bridge 3. When the electrode wire buckle 4 and the fixing arms 5 press the electrode wire, there may be a certain gap between the two fixing arms 5, or there may be an overlapping part between the two fixing arms 5.

[0058] Furthermore, the electrode wire wrapping portion further includes:

[0059] The fixing arm 5 is wrapped and arranged on the inner side of the silicone layer 6. The silicone layer 6 can prevent the sharp edge of the fixing arm 5 from puncturing the capsule, and prevent the electrode wire from being worn and compressed when pressure is applied to the electrode wire.

[0060] Furthermore, the wire coiling unit includes:

[0061] A first support column 7, one end of which is connected to the cross bridge 3, and the length of the first support column 7 is not greater than the diameter of the electrode wire, so as to prevent the first support column 7 from protruding from the coiled electrode wire;

[0062] A second support column 8, one end of which is connected to an end of the first support column 7 away from the cross bridge 3 through a splicing assembly;

[0063] The disk 9 is arranged on the second support column 8 at one end away from the first support column 7; it should be noted that the electrode wire is wound around the first support column 7 and the second support column 8 in the disk, so the diameter of the disk 9 should be larger than the diameter of the first support column 7 and the second support column 8.

[0064] The first support column 7, the second support column 8, the splicing assembly and the disc 9 are all made of silicone.

[0065] Furthermore, the splicing assembly includes:

[0066] A stitching ball 10 is arranged on one end of the first support column 7 close to the second support column 8;

[0067] The splicing groove 11 is arranged on one end of the second support column 8 close to the first support column 7, and the splicing groove 11, the splicing ball 10 and the splicing groove 11 are connected by a ball head. As can be seen from the above, the splicing ball 10 and the splicing groove 11 are both made of silicone material and have a certain plasticity, so the splicing ball 10 can be inserted into the splicing groove 11 to connect the first support column 7 and the second support column 8, and the splicing ball 10 can also be separated from the splicing groove 11 under the action of tension, so that the first support column 7 and the second support column 8 are disconnected.

[0068] It should be noted that the cross bridge 3, the electrode wire buckle 4, the fixed arm 5, the first support column 7, the second support column 8, the stitching ball 10 and the stitching groove 11, the parts that may contact the electrode wire are all set without sharp edges to prevent damage to the insulation layer on the pouch and the electrode wire.

[0069] When in use, after the electrode is placed in the correct position, part of the electrode wire can be wound outside the patient's body. At this time, the first support column 7 and the second support column 8 are connected together, and the electrode wire is wound on the first support column 7 and the second support column 8. Since the back of the pulse generator 2 is facing away from the field of vision during the operation, the disc 9 can be used as the operator's fulcrum. After winding, the disc 9 can be pulled, and the disc 9 and the second support column 8 can be taken out to reduce the possibility of infection in the capsule after the operation. Then bend the two electrode wire buckles 4 so that the electrode wire buckles 4 and the fixed arm 5 are pressed on the wound electrode wire, and the electrode wire is pressed and fixed on the cross bridge 3 in a disc shape, and finally set in the capsule. Among them, the pulse generator itself is similar to the size of a palm, and the electrode wire buckle 4 is also made of soft metal. Therefore, after pulling the disc 9, under the pressure and shielding of the operator's hand, the electrode wire can still be located on the cross bridge 3 in a disc shape. Operators who are not familiar with the technique of coiling the electrode wire can apply this application to improve the quality of the operation while improving efficiency. This application has a good guarantee for the stability of the electrode wire coil, whether during the operation or after a long operation. Furthermore, no part of this application protrudes beyond the pulse generator 2 and the electrode coil, and there is no sharp contact with the capsular bag, and no threat to the capsular bag tissue.

[0070] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention of the utility model.

Claims

1. A device for fixing the electrode wire of a pulse generator during pacemaker operation, characterized in that: include: An elastic band (1) is mounted on a pulse generator (2); An electrode wire wrapping portion is arranged on the back of the pulse generator (2) and connected to both ends of the elastic band (1); A wire coiling portion, arranged on the electrode wire wrapping portion; The wire coiling portion is suitable for winding an electrode wire of a pulse generator (2), and the electrode wire wrapping portion is suitable for fixing the electrode wire wound on the wire coiling portion.

2. The device for fixing the electrode wire of a pulse generator during pacemaker surgery according to claim 1, characterized in that: A plurality of striped protrusions are arranged on one side of the elastic band (1) close to the pulse generator (2).

3. The device for fixing the electrode wire of a pulse generator during pacemaker surgery according to claim 1, characterized in that: The electrode wire wrapping portion comprises: The cross bridge (3) is attached to the back of the pulse generator (2), and the two ends of the cross bridge (3) are respectively connected to the two ends of the elastic band (1), and the pulse generator (2) is set in the ring structure formed by the cross bridge (3) and the elastic band (1).

4. The device for fixing the electrode wire of a pulse generator during pacemaker surgery according to claim 3, characterized in that: The cross bridge (3) does not protrude beyond the sides of the pulse generator (2).

5. The device for fixing the electrode wire of a pulse generator during pacemaker surgery according to claim 3, characterized in that: The electrode wire wrapping portion further includes: There are two electrode wire buckles (4), which are respectively arranged on two end sides of the cross bridge (3).

6. The device for fixing the electrode wire of a pulse generator during pacemaker surgery according to claim 5, characterized in that: The electrode wire buckle (4) is made of soft metal.

7. The device for fixing the electrode wire of a pulse generator during pacemaker surgery according to claim 5, characterized in that: The electrode wire wrapping portion further includes: There are two fixed arms (5), which are arranged on the end of the electrode line buckle (4) away from the cross bridge (3) and correspond one to one with the electrode line buckle (4). The fixed arms (5) are fan-shaped.

8. The device for fixing the electrode wire of a pulse generator during pacemaker surgery according to claim 7, characterized in that: The electrode wire wrapping portion further includes: A silicone layer (6), wherein the fixed arm (5) is wrapped and arranged on the inner side of the silicone layer (6).

9. The device for fixing the electrode wire of a pulse generator during pacemaker surgery according to claim 3, characterized in that: The wire coiling unit comprises: A first support column (7), one end of which is connected to the cross bridge (3), and the length of the first support column (7) is not greater than the diameter of the electrode wire; A second support column (8), one end of which is connected to an end of the first support column (7) away from the cross bridge (3) via a splicing assembly; A disc (9) is arranged on an end of the second support column (8) away from the first support column (7); The first support column (7), the second support column (8), the splicing assembly and the disc (9) are all made of silicone.

10. The device for fixing the electrode wire of a pulse generator during pacemaker surgery according to claim 9, characterized in that: The splicing assembly comprises: A stitching ball (10) is arranged on one end of the first support column (7) close to the second support column (8); The splicing groove (11) is arranged on one end of the second supporting column (8) close to the first supporting column (7), and the splicing groove (11), the splicing ball (10) and the splicing groove (11) are connected by a ball head.

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