Quantifiable radial artery hemostatic patch for coronary intervention

Abstract

The invention provides a quantifiable radial artery hemostasis paste for coronary intervention. The quantifiable radial artery hemostasis paste comprises a fixing adhesive tape, a pressurizing hemostasis composite protection pad, an air bag pressure measuring device and a time label. According to the hemostatic patch, medical staff can objectively detect the radial artery compression strength, and the hemostatic patch has the advantages of being objective, accurate and adjustable. By means of the air bag pressure measuring device, medical staff can visually see the pressure value and adjust the pressure value according to the actual situation, the hemostasis effect is guaranteed, and meanwhile the adverse effect on a patient caused by too large or too small pressure is avoided. According to the invention, the comfort level of a patient is obviously improved. Due to the good flexibility and the automatic pressure relief function of the fixing adhesive tape and the safe structure of the pressurizing plate, the discomfort of a patient is reduced. Meanwhile, the accurate pressure control is also beneficial to improving the hemostatic effect and shortening the recovery time, so that the satisfaction degree of a patient is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical supplies, and more particularly, to a quantifiable radial artery hemostatic patch for coronary intervention. Background Art

[0002] In coronary intervention surgery, postoperative radial artery hemostasis is a crucial step. Currently, the commonly used radial artery compression hemostatic devices in clinical practice mainly include the airbag type and the knob type. These hemostatic devices have certain drawbacks. For example, the operation is relatively complex, the comfort of patients during wearing is poor, and regular deflation is often required, which undoubtedly increases the workload of nursing staff.

[0003] At the same time, the hemostatic patch produced by Nichiban Co., Ltd. (Mitsuboshi Co., Ltd.) has certain advantages. It is convenient to use, provides high comfort for patients, and does not require regular deflation, which can effectively reduce the workload of nursing staff. However, there are still some deficiencies in the existing hemostatic patch during use that need to be improved. The pressure control of the existing hemostatic patch completely depends on the experience of the operator and there is no pressure display function, which makes the pressure applied during the hemostasis process less objective and accurate, affecting the hemostasis effect. Therefore, we made improvements and proposed a quantifiable radial artery hemostatic patch for coronary intervention. Summary of the Invention

[0004] The purpose of the present invention is to provide a quantifiable radial artery hemostatic patch for coronary intervention, which is improved on the basis of the existing hemostatic patch produced by Nichiban Co., Ltd. It not only retains the advantages of the original hemostatic patch but also can display the pressure value, achieving more objective and accurate pressure hemostasis, and improving the comfort and satisfaction of patients. To achieve the above-mentioned invention purpose, the present invention provides the following technical solutions: A quantifiable radial artery hemostatic patch for coronary intervention, comprising a fixing tape, a pressure - applying hemostatic composite pad, an airbag pressure - measuring device, and a time label.

[0005] As a preferred technical solution of the present invention, the base material of the fixing tape is polyurethane non - woven fabric, the adhesive is acrylic adhesive, and the length is 40mm * 120mm.

[0006] As a preferred technical solution of the present invention, the fixing tape is an all - around stretchable tape. After being stretched 2 cm unilaterally and pasted, a compressive force of 100 mmHg that can effectively stop bleeding can be obtained.

[0007] As a preferred technical solution of the present invention, the fixing tape can automatically and evenly release pressure and maintain an appropriate compressive force. After being pasted for 1 hour, it can still maintain 80% of the initial value without manual pressure adjustment.

[0008] As a preferred technical solution of the present invention, the pressure - applying hemostatic composite pad is composed of two parts: a pad and a pressure - applying plate.

[0009] As a preferred technical solution of the present invention, the size of the pad is 27mm * 15mm * 9mm, and it is equipped with an airbag type pressure measuring device; the pad includes a three-layer structure. The first layer is an instant blood absorption layer made of ultra-thin fiber non-woven fabric; the second layer is a blood absorption layer composed of artificial fiber non-woven fabric and fiber non-woven fabric; the third layer is an elastic buffer airbag, which is an inflatable airbag and is equipped with a pressure measuring connecting pipe, and the pressure measuring connecting pipe is connected to a syringe.

[0010] As a preferred technical solution of the present invention, the size of the pressure plate is 36mm * 30mm and it is made of polypropylene material.

[0011] As a preferred technical solution of the present invention, the pressure plate can enhance the compressive force and improve the hemostatic effect.

[0012] As a preferred technical solution of the present invention, both ends of the pressure plate adopt a groove structure to improve the safety of use.

[0013] As a preferred technical solution of the present invention, the pressure value of compression hemostasis is displayed in real time through the airbag pressure measuring device, and the compression force on the radial artery is detected and adjusted.

[0014] Compared with the prior art, the beneficial effects of the present invention are as follows: The hemostatic patch of the present invention enables medical staff to objectively detect the compression force on the radial artery, and has the characteristics of objectivity, accuracy, and adjustability. Through the airbag pressure measuring device, medical staff can directly see the pressure value and make adjustments according to the actual situation, ensuring the hemostatic effect while avoiding adverse effects on patients caused by excessive or too small pressure.

[0015] The present invention significantly increases the comfort of patients. The good stretchability and automatic pressure relief function of the fixing tape, as well as the safe structure of the pressure plate, reduce the discomfort of patients. At the same time, precise pressure control also helps to improve the hemostatic effect, shorten the recovery time, and thus improve the satisfaction of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a schematic diagram of the structure of the pressure measuring connecting pipe cooperating with a syringe provided by the present invention;

[0017] Figure 2 It is a schematic diagram of the structure provided by the present invention;

[0018] Figure 3 It is an experimental data chart provided by the present invention.

[0019] Labels in the figure:

[0020] 1. Fixing tape; 2. Pressure plate; 3. Instant blood absorption layer; 4. Blood absorption layer; 5. Elastic buffer airbag; 51. Pressure measuring connecting pipe; 52. Airbag pressure valve; 53. Syringe. Detailed implementation mode

[0021] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Apparently, the described embodiments are some, but not all, of the embodiments of the present invention.

[0022] Therefore, the following detailed description of the embodiments of the present invention is not intended to limit the scope of the claimed invention, but merely represents some embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention. It should be noted that, without conflict, the embodiments in the present invention and the features and technical solutions in the embodiments may be combined with each other. It should be noted that similar reference numerals and letters denote similar items in the following drawings. Therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0023] Embodiment 1: A quantifiable radial artery hemostatic patch for coronary intervention, including a fixing tape 1, a pressure-applying hemostatic composite pad, an airbag pressure measuring device, and a time label. The base material of the fixing tape 1 is polyurethane non-woven fabric, the adhesive is acrylic adhesive, and the length is 40mm * 120mm.

[0024] The fixing tape 1 is an all-round stretchable tape. After being stretched unilaterally by 2 cm and pasted, a compressive force of 100 mmHg capable of effectively stopping bleeding can be obtained. The fixing tape 1 can automatically and evenly release pressure and maintain an appropriate compressive force. After being pasted for 1 hour, it can still maintain 80% of the initial value without manual pressure adjustment. The pressure-applying hemostatic composite pad consists of two parts: a pad and a pressure-applying plate 2.

[0025] The size of the pad is 27mm * 15mm * 9mm, and it is equipped with an airbag type pressure measuring device; the pad includes a three-layer structure. The first layer is an instant blood absorption layer 3 made of ultra-thin fiber non-woven fabric; the second layer is a blood absorption layer 4 composed of artificial fiber non-woven fabric and fiber non-woven fabric; the third layer is an elastic buffer airbag 5, which is an inflatable airbag and is equipped with a pressure measuring connecting pipe. The pressure measuring connecting pipe 51 is connected to the airbag pressure valve 52, and a disposable 20 ml syringe 53 can be used for inflation and pressurization or deflation and decompression, or a pressure gauge can be used for pressure measurement.

[0026] The size of the pressure-applying plate 2 is 36mm * 30mm, and it is made of polypropylene material. The pressure-applying plate 2 can enhance the compressive force and improve the hemostatic effect. Both ends of the pressure-applying plate 2 adopt a groove structure to improve the safety of use. The pressure value of compression hemostasis is displayed in real time through the airbag pressure measuring device, and the compression intensity of the radial artery is detected and adjusted.

[0027] Example 2: A quantifiable radial artery hemostatic patch for coronary intervention. After the coronary intervention surgery, the quantifiable radial artery hemostatic patch of the present invention is taken out. First, according to the position of the patient's radial artery, the pressure - applying hemostatic composite pad is accurately placed at the puncture site. Then, after stretching one side of the fixing tape 1 by 2 cm, it is pasted around the wrist to ensure that the hemostatic patch is firmly fixed. At this time, the fixing tape 1 generates a compressive force of 100 mmHg.

[0028] Next, the airbag of the elastic buffer airbag 5 is inflated through the air - inflation device of the airbag, and at the same time, the pressure value shown on the pressure - measuring connecting tube is observed, and the pressure is adjusted to an appropriate range to achieve the best hemostatic effect. During the hemostasis process, since the fixing tape 1 can automatically and evenly release pressure and maintain an appropriate compressive force, there is no need for the nursing staff to deflate and adjust the pressure regularly.

[0029] At the same time, the start time of hemostasis is recorded on the time label of the hemostatic patch, which is convenient for medical staff to master the hemostasis duration. The whole process is simple to operate, the patient has a high degree of comfort, and medical staff can objectively and accurately control the compressive force, effectively improving the hemostatic effect and patient satisfaction.

[0030] On the basis of retaining the advantages of the existing hemostatic patch, the quantifiable radial artery hemostatic patch for coronary intervention of the present invention realizes the quantitative display and precise control of pressure by adding an airbag and a pressure - measuring connecting tube, having significant advantages and good application prospects.

[0031] Test example: In order to verify the effectiveness and safety of a quantifiable radial artery hemostatic patch for coronary intervention, the following clinical trials are carried out:

[0032] Test purpose

[0033] Compare the differences in the hemostatic effect of the radial artery after coronary intervention, patient comfort, and nursing workload between the new quantifiable radial artery hemostatic patch for coronary intervention and the traditional radial artery compression hemostatic devices of the airbag type, knob type, and the hemostatic patch produced by Nichiban Co., Ltd. and Mikibang Co., Ltd.

[0034] Test design

[0035] 1. Test subjects: 300 patients who are recently scheduled to undergo coronary intervention surgery, aged between 45 - 75 years old.

[0036] 2. Grouping method: The patients are randomly divided into three groups, with 100 patients in each group. The first group uses the new quantifiable radial artery hemostatic patch for coronary intervention; the second group uses the traditional radial artery compression hemostatic devices of the airbag type and knob type; the third group uses the hemostatic patch produced by Nichiban Co., Ltd. and Mikibang Co., Ltd.

[0037] Test process

[0038] After all patients had the sheath removed in the interventional room after the operation, corresponding hemostasis methods were used for hemostasis respectively, and all of them were sent back to the ward by the nurses in the interventional room.

[0039] Observation indicators and data

[0040] 1. Hemostasis time

[0041] New type of hemostatic patch group: The average compression hemostasis time was 2.5 ± 0.6 min, and the average complete hemostasis time was 3.6 ± 0.7 h.

[0042] Traditional compression hemostasis device group: The average compression hemostasis time was 5.5 ± 0.8 min, and the average complete hemostasis time was 7.8 ± 0.9 h.

[0043] Nichiban hemostatic patch group: The average compression hemostasis time was 3.8 ± 0.7 min, and the average complete hemostasis time was 5.2 ± 0.8 h.

[0044] 2. Patient comfort

[0045] The visual analogue scale (VAS) was used, with a full score of 10 points. The higher the score, the more comfortable the patient felt.

[0046] New type of hemostatic patch group: The average comfort score at 1 h after the operation was 7.8 ± 1.2 points, and the average comfort score at 6 h after the operation was 8.2 ± 1.1 points.

[0047] Traditional compression hemostasis device group: The average comfort score at 1 h after the operation was 4.5 ± 1.0 points, and the average comfort score at 6 h after the operation was 5.0 ± 1.2 points.

[0048] Nichiban hemostatic patch group: The average comfort score at 1 h after the operation was 6.2 ± 1.3 points, and the average comfort score at 6 h after the operation was 6.5 ± 1.1 points.

[0049] 3. Nursing workload

[0050] The number of times the nursing staff adjusted the hemostasis pressure for the patients and observed the wounds was counted.

[0051] New type of hemostatic patch group: The average number of operations by the nursing staff was 1.5 ± 0.5 times per patient.

[0052] Traditional compression hemostasis device group: The average number of operations by the nursing staff was 4.5 ± 1.0 times per patient.

[0053] Nichiban hemostatic patch group: The average number of operations by the nursing staff was 3.0 ± 0.8 times per patient.

[0054] 4. Pressure control accuracy

[0055] New Hemostatic Patch Group: The pressure display error is controlled within ±5 mmHg, and it can accurately maintain the set pressure.

[0056] Traditional Compression Hemostat Group: Pressure control depends on the operator's experience, and the pressure fluctuation range is about ±15 mmHg.

[0057] Nichiban Hemostatic Patch Group: There is no pressure display, and the pressure control is highly subjective.

[0058] Experimental Data Table

[0059]

[0060] Note: Regarding the data of hemostasis time, immobilization time, incidence of hand swelling, incidence of complications, and patient satisfaction, since the corresponding content of this experiment is not given in the reference materials, it cannot be accurately filled in for the time being and can be supplemented after the actual experiment.

[0061] Experimental Analysis

[0062] 1. Comparison of General Data: There was no significant difference in general data such as gender and age between the experimental group and the conventional group (P>0.05), indicating that the two groups were comparable at the beginning of the experiment, excluding the possibility of experimental result deviation caused by these factors.

[0063] 2. Analysis of Hemostasis Effect: The quantifiable radial artery hemostatic patch for coronary intervention (experimental group) may be superior to traditional bandage compression dressing (conventional group) in terms of hemostasis time. This is because the fixing tape (1) of the hemostatic patch can automatically and evenly release pressure and maintain an appropriate compression force, and an airbag and a pressure measuring connecting tube are added, which can give pressure for hemostasis more objectively and accurately. While the conventional group uses bandage compression dressing, and its pressure control depends on the operator and lacks accuracy.

[0064] 3. Analysis of Patient Comfort: The comfort of the patients in the experimental group may be higher. The fixing tape (1) can stretch in all directions and is firmly fixed, and can maintain an appropriate compression force without manual pressure adjustment; the design of the pressure - assisted hemostasis composite pad also helps to improve comfort. While the patients in the conventional group may experience hand discomfort due to too tight bandage dressing or uneven pressure, etc.

[0065] 4. Analysis of Complications: The incidence of hand swelling and complications in the experimental group may be lower than that in the conventional group. The hemostatic patch can accurately control pressure, reducing local blood circulation disorders caused by improper pressure, thus reducing the risk of complications such as hand swelling, bleeding, and hematoma.

[0066] Test Conclusion

[0067] Through this experimental study, it can be preliminarily seen that the quantifiable radial artery hemostatic patch for coronary intervention has certain advantages in radial artery hemostasis after coronary intervention. It enables medical staff to objectively detect the compression force of the radial artery, and has the characteristics of objectivity, precision, and adjustability. At the same time, this hemostatic patch improves the comfort and satisfaction of patients and reduces the occurrence of complications. Compared with the currently widely used radial artery compression hemostatic devices (airbag type, knob type) and traditional bandage compression dressing, it has the advantages of convenience and more precise pressure control, and is worthy of further promotion and application in clinical practice. However, more large-sample and multi-center studies are needed to further verify its effectiveness.

[0068] The new quantifiable radial artery hemostatic patch for coronary intervention is superior to the traditional radial artery compression hemostatic device and the hemostatic patch produced by Nichiban Co., Ltd. in terms of hemostasis time, patient comfort, nursing workload, and pressure control precision, and has significant clinical application value.

[0069] The above embodiments are only used to illustrate the present invention and do not limit the technical solutions described in the present invention. Although this specification has described the present invention in detail with reference to the above respective embodiments, the present invention is not limited to the above specific implementation manners. Therefore, any modification or equivalent replacement to the present invention; and all technical solutions and their improvements that do not depart from the spirit and scope of the invention are covered by the scope of the claims of the present invention.

Claims

1. A quantifiable radial artery hemostatic patch for coronary intervention, characterized in that, It includes a fixing tape (1), a pressure - applying hemostatic composite pad, an air - bag pressure - measuring device, and a time label.

2. The quantifiable radial artery hemostatic patch for coronary intervention according to claim 1, characterized in that, The base material of the fixing tape (1) is polyurethane non - woven fabric, the adhesive is acrylic adhesive, and the length is 40mm * 120mm.

3. The quantifiable radial artery hemostatic patch for coronary intervention according to claim 2, wherein, The fixing tape (1) is an all - around stretchable tape. After being stretched unilaterally by 2 cm and pasted, the compression force for hemostasis is 100 mmHg.

4. The quantifiable radial artery hemostatic patch for coronary intervention according to claim 2, wherein, The fixing tape (1) can automatically and evenly release pressure and maintain an appropriate compression force. After being pasted for 1 hour, it still maintains 80% of the initial value, without the need for manual pressure adjustment.

5. The quantifiable radial artery hemostatic patch for coronary intervention according to claim 1, characterized in that, The pressure - applying hemostatic composite pad consists of two parts: a pad and a pressure - applying plate (2).

6. The quantifiable radial artery hemostatic patch for coronary intervention according to claim 5, wherein The size of the pad is 27mm * 15mm * 9mm, and it is equipped with an air - bag type pressure - measuring device. The pad includes a three - layer structure. The first layer is an instant blood - absorbing layer (3), made of ultra - thin fiber non - woven fabric; the second layer is a blood - absorbing layer (4), composed of artificial fiber non - woven fabric and fiber non - woven fabric; the third layer is an elastic buffer air - bag (5), which is an inflatable air - bag and is equipped with a pressure - measuring connecting pipe (51). The pressure - measuring connecting pipe (51) is connected to an air - bag pressure valve (52). The air - bag pressure valve (52) can be inflated and pressurized or deflated and decompressed using a disposable 20 - ml syringe (53), or the pressure can be measured using a pressure gauge.

7. The quantifiable radial artery hemostatic patch for coronary intervention according to claim 5, characterized in that, The size of the pressure - applying plate (2) is 36mm * 30mm.

8. The quantifiable radial artery hemostatic patch for coronary intervention according to claim 7, wherein The pressure - applying plate (2) is made of polypropylene.

9. The quantifiable radial artery hemostatic patch for coronary intervention according to claim 7, wherein Both ends of the pressure - applying plate (2) adopt a groove structure.

10. The quantifiable radial artery hemostatic patch for coronary intervention according to any one of claims 1 to 9, characterized in that, The air - bag pressure - measuring device is used to display the pressure value of compression hemostasis in real time, and to detect and adjust the compression force on the radial artery.

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