WO2021008004A1 - 止血贴 - Google Patents

止血贴 Download PDF

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Publication number
WO2021008004A1
WO2021008004A1 PCT/CN2019/114744 CN2019114744W WO2021008004A1 WO 2021008004 A1 WO2021008004 A1 WO 2021008004A1 CN 2019114744 W CN2019114744 W CN 2019114744W WO 2021008004 A1 WO2021008004 A1 WO 2021008004A1
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WO
WIPO (PCT)
Prior art keywords
hemostatic
layered
hemostatic patch
pressure
patch
Prior art date
Application number
PCT/CN2019/114744
Other languages
English (en)
French (fr)
Inventor
李伟
姚兰
汤义
刘鲲鹏
王宝宁
Original Assignee
李伟
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 李伟 filed Critical 李伟
Publication of WO2021008004A1 publication Critical patent/WO2021008004A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • G—PHYSICS
    • G08—SIGNALLING
    • G08B—SIGNALLING OR CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS
    • G08B21/00—Alarms responsive to a single specified undesired or abnormal condition and not otherwise provided for
    • G08B21/18—Status alarms
    • G08B21/24—Reminder alarms, e.g. anti-loss alarms
    • G—PHYSICS
    • G08—SIGNALLING
    • G08B—SIGNALLING OR CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS
    • G08B3/00—Audible signalling systems; Audible personal calling systems
    • G08B3/10—Audible signalling systems; Audible personal calling systems using electric transmission; using electromagnetic transmission
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B2017/12004—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for haemostasis, for prevention of bleeding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00463—Plasters use haemostatic
    • A61F2013/00468—Plasters use haemostatic applying local pressure

Definitions

  • the invention relates to a hemostatic patch, belonging to the field of medical devices, and in particular to a disposable pressure hemostatic patch.
  • Arteriovenous blood sampling is a common examination item. After blood collection, the needle hole often requires the patient himself or others to use cotton swabs or cotton balls to stop the bleeding. Subcutaneous congestion and even infection are prone to occur when the pressure is not in place. If infants cry after blood collection, it is more difficult to press to stop bleeding. If it is in the cold winter, pressing exposed limbs for a long time may also cause a cold.
  • the Chinese patent application number 200620074135.3 discloses a hemostatic adhesive patch for human vein needle holes, in which an elastic water-absorbing body is bonded to a medical tape.
  • the Chinese patent application number 201820133673.8 discloses a compression hemostatic patch, in which the body of the hemostatic patch includes a connecting part, an elastic capsule and a hemostatic cotton in order from top to bottom.
  • the Chinese patent application number 201510066229.X discloses a pressure-adjustable hemostatic patch, which adjusts the pressure by rotating a pressing plug.
  • there are some hemostatic stickers with complex structure and troublesome operation which increases manufacturing cost and use cost.
  • the above hemostatic patch overcomes some shortcomings to a certain extent, but still has one or more of the following shortcomings:
  • the elastic pressure body protrudes from the base band, and there is a certain gap between the base band around the elastic pressure body and the skin during use.
  • the base band cannot be smoothly pasted on the skin, which will easily cause the base band to separate from the human skin and affect the hemostatic effect and/or product Miniaturization;
  • the pressure is fixed, and the pressure cannot be adjusted for different parts and different types of wounds, and the applicability is poor;
  • the pressing time cannot be controlled, and some parts or some patients cannot be pressed for a long time, otherwise there is a risk of tissue ischemic necrosis, and the safety is poor;
  • the product structure is complex, the operation is complicated, the volume is large, the use experience is poor, and the cost is high.
  • the present invention provides a hemostatic patch, which is characterized by comprising:
  • the first layered element has a first thickness
  • the second layered element has a second thickness and has a first surface and a second surface.
  • the first surface is connected to the first layered element, the second surface is provided with an adhesive material, and the second layered A through hole is provided on the component;
  • a retractable pressure applying element is arranged in the through hole, and one end is connected to the first layered element, and the other end is connected to the following hemostatic element;
  • the hemostatic element when the hemostatic patch is in the working state, the hemostatic element is basically located in the through hole.
  • the hemostatic patch can be closely attached to the part to be hemostatic and its surroundings without gaps, can provide greater adhesion and is conducive to miniaturization
  • the pressure applying element includes a stretchable elastic element.
  • the pressure applying element includes a spring.
  • the first layered element and the second layered element are integrally formed.
  • the hemostatic patch further includes a protective element that is detachably connected to the second surface of the second layered element.
  • the protective element is a protective isolation cover.
  • the hemostatic patch includes two or more hemostatic elements that are sequentially stacked and separable, and the two or more hemostatic elements have contact surfaces with the same area or contact surfaces with different areas.
  • the contact surfaces of the two or more hemostatic elements decrease sequentially from top to bottom.
  • a circumferential dividing line is provided on the two or more hemostatic elements.
  • the hemostatic patch is preferably round, square or heart-shaped.
  • a protruding part is preferably provided on the protection element.
  • the hemostatic patch preferably further includes a timer and a warning unit.
  • the timer and the first layered element are preferably integrally arranged.
  • the hemostatic patch preferably further includes a pressure sensing unit and a time setting unit, and the time setting unit sets the compression hemostasis time according to the pressure sensed by the pressure sensing unit.
  • the hemostatic patch is preferably a disposable hemostatic patch.
  • the timer automatically starts timing when the pressure sensed by the pressure sensing unit is within a predetermined range.
  • the second thickness of the second layered element is preferably adjustable, and the second layered element preferably includes two or more separable lamination units.
  • a hemostatic patch is also provided, which is characterized in that it is composed of the following elements:
  • the second layered element has a first surface and a second surface, the first surface is connected to the first layered element, the second surface is provided with an adhesive material, and the second layered element is provided with a hole;
  • a pressure applying element which is arranged in the through hole, and one end is connected to the first layered element, and the other end is connected to the following hemostatic element;
  • a protection element which is detachably connected to the second surface of the second layered element
  • the hemostatic element when the hemostatic patch is in the working state, the hemostatic element is basically located in the through hole.
  • the present invention has one or more of the following technical effects:
  • the hemostatic element is accommodated in the through hole during operation without protruding from the second surface of the second layered element.
  • the hemostatic patch fits closely to the skin, which can provide greater adhesion and at the same time facilitate the bonding area and Miniaturization of products;
  • Timing alarm reminder can be realized, and the timing time or pressing time can be automatically set;
  • the stretchable elastic element can make the hemostatic element protrude through the through hole by a predetermined length under the action of gravity and/or elastic force, which is beneficial for the user to align the hemostatic element to the position to be hemostasis.
  • Figure 1 is a cross-sectional view of a hemostatic patch structure according to a preferred embodiment of the present invention
  • FIG. 2 is a schematic diagram of the structure of the hemostatic patch in FIG. 1 after removing the protective element;
  • FIG. 3 is a schematic diagram of the working state of the hemostatic patch in Figure 2;
  • FIG. 4 is a schematic diagram of a first layered element according to a preferred embodiment of the present invention.
  • Fig. 5 is a schematic diagram of a second layered element according to a preferred embodiment of the present invention.
  • Figure 6 is a schematic diagram of a hemostatic element according to a preferred embodiment of the present invention.
  • Figure 7 is a cross-sectional view of a hemostatic patch structure (after removing the protective element) according to another preferred embodiment of the present invention.
  • Figure 8 is a cross-sectional view of a hemostatic patch structure (after removing the protective element) according to another preferred embodiment of the present invention.
  • Fig. 9 is a schematic structural diagram of a hemostatic element of a hemostatic patch according to another preferred embodiment of the present invention.
  • Fig. 10 is a schematic diagram of a second layered element of a hemostatic patch according to another preferred embodiment of the present invention.
  • the hemostatic patch includes: a first layered element 1 having a first thickness; a second layered element 2 having a second thickness and having a first surface and a second surface, the first surface and the first layered element 1 Connection, the second surface is provided with an adhesive material, the second layered element 2 is provided with a through hole; the retractable pressure applying element 3 is provided in the through hole, and one end is connected to the first layer
  • the hemostatic element 1 is connected, and the other end is connected to the following hemostatic element 4;
  • the second thickness is greater than the first thickness.
  • the first thickness can be determined according to the magnitude of the force exerted by the pressure applying element 3 on the first layered element 1.
  • the second thickness can be jointly determined according to the length of the pressure applying element 3 in the compressed state and the thickness of the hemostatic element.
  • the hemostatic element 4 is substantially located in the through hole when the hemostatic patch is in the working state.
  • the hemostatic patch basically does not protrude from the second surface of the second laminar element 2, which facilitates the smooth adhesion of the second surface to the skin 8 and provides a stable adhesive force.
  • the present invention requires a smaller bonding area, which is beneficial to the miniaturization of the hemostatic patch.
  • the hemostatic patches in the prior art all include a large-sized elongated base tape or adhesive tape.
  • the hemostatic element 4 is basically located in the through hole
  • the contact surface of the hemostatic element 4 and the second surface of the second layered element 2 are substantially in the same plane, which can be realized
  • the application of pressure can also ensure that the hemostatic element 4 basically does not protrude from the second surface of the second layered element 2.
  • the term “basically” here also includes that when the applied pressure is large, the softer part to be hemostatic may be slightly displaced under the pressure, so that the hemostatic element 4 slightly protrudes from the second layered element 2 Two superficial situations. It can be understood that when the hemostatic element 4 is substantially located in the through hole, the second surface of the second layered element 2 can be smoothly attached to the surrounding area to be hemostatic.
  • FIG. 2 is a schematic diagram of the structure of the hemostatic patch after removing the protective element 5.
  • the pressure applying element 3 can extend a certain distance under the action of gravity after the protective element 5 is removed. Since the pressure applying element 3 extends out of the through hole for a certain distance, the user can easily see the position of the hemostatic element 4 without being blocked by the first and second layered elements 2, which is beneficial for positioning the hemostatic element 4 to the predetermined position. Target, not vice versa.
  • the pressure applying element 3 After the protection element 5 is installed, the pressure applying element 3 is in a natural extended state or a certain compressed state. It can be understood that when the pressure applying element 3 is in a certain compressed state after the protection element 5 is installed, it is beneficial to realize the miniaturization and portability of the hemostatic patch.
  • the pressure applying element 3 includes a stretchable elastic element or the like.
  • the pressure applying element 3 includes a spring or the like.
  • the first layered element 1 and the second layered element 2 are integrally formed.
  • a recessed hole can be directly provided therein as a through hole on the second layered element 2, which can reduce the manufacturing process and reduce the cost.
  • the hemostatic patch further includes a protective element 5 that is detachably connected to the second surface of the second layered element 2.
  • the protective element 5 is, for example, a protective isolation cover.
  • the protective isolation cover can be formed in the shape of a hat with a lower peripheral edge, which is adhered to the second surface of the second layered element 2, and the protruding cap surrounds the hemostatic element 4 and the spring.
  • Fig. 4 is a schematic diagram of a first layered element 1 according to a preferred embodiment of the present invention.
  • the first layered element 1 is preferably circular, but is not limited to this. For example, it may also be square, heart-shaped, rectangular, oval, polygonal, and the like.
  • the round, square or heart-shaped first layered element 1 is conducive to miniaturization of the hemostatic patch.
  • the first layered element 1 has a smaller thickness than the second layered element 2.
  • Fig. 5 is a schematic diagram of a second layered element 2 according to a preferred embodiment of the present invention.
  • the second layered element 2 is preferably a cylinder with a through hole in the center, but is not limited to this.
  • it may also be a cube, a heart-shaped cylinder, a cuboid, an elliptical cylinder, a polygonal cylinder, and the like.
  • the second layered element 2 can be made of the same material as the first layered element 1, for example, or can be made of a different material.
  • Fig. 6 is a schematic diagram of a hemostatic element 4 according to a preferred embodiment of the present invention.
  • the hemostatic element 4 is preferably circular, but not limited to this. For example, it may also be square, heart-shaped, rectangular, oval, polygonal, and the like.
  • the circular hemostatic element 4 is useful for adjusting the pressure.
  • the diameter of the hemostatic element 4 may be larger than the diameter of the spring, but smaller than the diameter of the through hole, but it is not limited thereto.
  • the diameter of the hemostatic element 4 may also be equal to or smaller than the diameter of the spring, for example.
  • FIG. 7 is a cross-sectional view of a hemostatic patch structure (after removing the protective element 5) according to another preferred embodiment of the present invention.
  • the hemostatic patch includes two or more hemostatic elements 4 stacked in sequence and separable, for example 3 or more.
  • Two or more hemostatic elements 4 have contact surfaces of different areas.
  • the term "contact surface” is defined as the surface that is in contact with the site to be hemostatic, that is, the target site. As shown in Fig. 7, the contact surfaces of the three hemostatic elements 4 decrease sequentially from top to bottom. More specifically, the hemostatic elements 4 having smaller and smaller areas are sequentially stacked from the other end of the spring.
  • the hemostatic element 4 with the smallest area at the bottom defines the smallest pressure application area.
  • the smaller the force area the greater the pressure received. Conversely, the lower the pressure received.
  • the pressure per unit area of the target position can be adjusted. For example, when it is necessary to provide the maximum pressure, the lowermost hemostatic element 4 is used directly. At this time, the force-bearing area is the smallest and the compression of the spring is the largest; when the minimum pressure is required, the two lower hemostatic elements 4 are removed. The one hemostatic element 4 with the largest contact area is retained. At this time, the force-bearing area is the largest and the compression of the spring is the smallest.
  • the area of the smallest hemostatic element 4 is, for example, 1/2 to 1/3, or even 1/4 of the area of the largest hemostatic element 4.
  • FIG 8 is a cross-sectional view of a hemostatic patch structure (after removing the protective element 5) according to another preferred embodiment of the present invention.
  • the hemostatic patch includes two or more hemostatic elements 4 stacked in sequence and separable, for example 3 or more. Two or more hemostatic elements 4 have contact surfaces of the same area. As shown in Fig. 8, the contact surfaces of the three hemostatic elements 4 have the same area.
  • Fig. 9 is a schematic structural diagram of the hemostatic element 4 of the hemostatic patch according to another preferred embodiment of the present invention.
  • the hemostatic element 4 is provided with a circumferential dividing line 7.
  • at least one of the three hemostatic elements 4 in FIG. 8 is provided with one, two or more circumferential dividing lines 7.
  • the user can easily remove a part of the hemostatic element 4 along one or more circumferential dividing lines 7 according to actual needs to change the area of the hemostatic element 4.
  • the area of the hemostatic element 4 can be reduced to 1/2 to 1/3, or even 1/4.
  • Two or more hemostatic elements 4 far away from the spring are preferably provided with one or more circumferential dividing lines 7, and one hemostatic element 4 closest to the spring is not provided with a dividing line, but the present invention is not limited to this.
  • the protection element 5 is preferably provided with a protruding part 6.
  • the user can easily remove the protective element 5 by pinching the protruding part 6 by hand to take out the hemostatic element 4.
  • the hemostatic patch is preferably round, square or heart-shaped. There is preferably a predetermined gap between the hemostatic element 4 and the pressure applying element 3 and the inner surface of the through hole to prevent the hemostatic element 4 from adhering to the second surface of the second layered element 2.
  • the hemostatic patch preferably further includes a timer and a warning unit (not shown).
  • a timer usually a small pressure and about 5-10 minutes of compression are required.
  • a warning unit usually a greater pressure and about 15-20 minutes or even longer compression.
  • the timer can be used to set the pressing time and remind the user to stop pressing in time.
  • the timer and the first layered element 1 are integrally arranged. This is conducive to simplifying the product structure and manufacturing process and reducing costs.
  • the hemostatic patch preferably further includes a pressure sensing unit and a time setting unit, and the time setting unit sets the compression hemostasis time according to the pressure sensed by the pressure sensing unit.
  • the sensed pressure is greater than the set first threshold, it is determined that arterial blood sampling is performed, and the corresponding compression hemostasis time is set.
  • the sensed pressure is between the set first threshold and the second threshold, it is determined that blood is drawn from the vein, and the corresponding compression hemostasis time is set.
  • the pressure sensing unit is arranged on the spring or the first layered element 1, preferably on the hemostatic element 4.
  • the pressure sensing unit is used to sense the pressure applied by the hemostatic element 4 to the target part to determine whether it is venous blood sampling or arterial blood sampling, for example, and the time setting unit automatically sets the corresponding timing time or pressing time according to the determination result.
  • the hemostatic pressure required after venous blood collection is, for example, 10-15 mmHg/unit area, and the hemostatic pressure required after arterial blood collection is, for example, 50-60 mmHg/unit area, and the present invention is not limited to this.
  • the intelligent hemostatic patch can be adapted to high-end consumer groups.
  • a timer is started to start timing.
  • a hemostatic patch is also provided, which is composed of the following elements: a first layered element 1; a second layered element 2 having a first surface and a second surface, The first surface is connected to the first layered element 1, the second surface is provided with an adhesive material, the second layered element 2 is provided with a through hole; the pressure applying element 3 is provided in the through hole , And one end is connected to the first layered element 1, and the other end is connected to the following hemostatic element 4; hemostatic element 4; and a protective element 5, which is detachably connected to the second surface of the second layered element 2
  • the hemostatic element 4 when the hemostatic patch is in the working state, the hemostatic element 4 is basically located in the through hole.
  • a disposable pressure hemostatic patch which includes a first layered element 1, a second layered element 2, a pressure applying element 3, a hemostatic element 4 and a protective element 5.
  • the second layered element 2 has a first surface and a second surface, the first surface is connected to the first layered element 1, the second surface is provided with an adhesive material, and the second layered element 2 is provided There are through holes.
  • the pressure applying element 3 is arranged in the through hole, and one end is connected to the first layered element 1 and the other end is connected to the following hemostatic element 4.
  • the protective element 5 is detachably connected to the second surface of the second layered element 2.
  • the hemostatic element 4 is basically located in the through hole when the hemostatic patch is in the working state.
  • the hemostatic patch can be closely attached to the part to be hemostatic and its surroundings without gaps, can provide greater adhesion and is beneficial to miniaturization.
  • the first layered element 1 is, for example, a substrate, and the second layered element 2 is, for example, an adhesive pad with holes.
  • the hemostatic element 4 is, for example, a water-absorbing sheet.
  • the base body is made of, for example, plastic sheets or non-elastic cloth sheets.
  • a round hole is provided in the center of the pasting pad, the first surface is pasted with a corresponding size matrix, and the second surface is covered with an adhesive layer.
  • the gasket may be made of materials such as foam, plastic or silicone.
  • the pressure applying element 3 is preferably a spring whose diameter is slightly smaller than the round hole of the gasket, and the spring is located in the round hole.
  • the spring is fixed on the base body, and the other end is fixed with a water-absorbing sheet, which can be made of cotton, gauze or sponge.
  • the absorbent sheet contains medicinal ingredients that have hemostatic, analgesic and/or anti-inflammatory effects.
  • the length of the spring and absorbent sheet is longer than the thickness of the gasket.
  • the spring and absorbent sheet are not higher than the thickness of the gasket. That is, it is completely contained in the round hole of the gasket at this time, which is beneficial to ensure that the gasket and the skin 8 are completely tightly attached during use.
  • the gasket and the absorbent sheet are sealed by a protective cover with a recess.
  • the spring is in a freely stretched state or a certain compressed state.
  • the protective cover can be made of plastic or paper and its edge or corner is divided into two, which is convenient to use The protective cover is separated from the gasket.
  • the absorbent sheet can be stacked in multiple layers. When a higher pressure is required, use a multilayer absorbent sheet directly at the wound. When a lower pressure is required, tear off one or more layers of absorbent Use after film. When minimum pressure is required, only the last layer of absorbent sheet is retained.
  • the second thickness of the second layered element 2 is adjustable.
  • the compression amount of the retractable pressure applying element such as a spring during the operation of the hemostatic patch can be adjusted, so that the pressure or pressure applied to the hemostatic element and the part to be hemostatic can be adjusted.
  • the second layered element 2 includes two, three or more lamination units. These lamination units can be divided by a circumferential cutting line 9 provided, for example. Alternatively, these lamination units are laminated to each other through an adhesive layer on the surface. In use, one or more lamination units can be easily removed along the cutting line or the adhesive layer, but it is not limited thereto.
  • the thickness of the second layered element 2 can also be increased.
  • a timer capable of sounding is fixed on the top surface of the substrate.
  • the corresponding time can be set according to the pressed part and the type of wound. After the hemostatic paste is attached to the skin 8, the timer will automatically start the timer. After the timer is over, the timer will be a miniature speaker An alarm sound is emitted.
  • the washer and spring can also be directly fixed on the timer, eliminating the need for the base body, and the above functions can also be achieved.
  • the hemostatic patch of the present invention is used for compression of the venous blood collection needle hole. At this time, less pressure is required to complete hemostasis. Specifically, first, the protective cover of the hemostatic patch is peeled off or torn off, the spring extends out of the round hole for a certain distance, the hemostatic element 4 is aligned with the pinhole, and then the entire hemostatic patch is glued to the target site, counting down for 5 to 10 minutes Then call the police, remove the hemostatic patch, and complete hemostasis.
  • the process of use may also include the step of removing the hemostatic element 4 to adjust the pressure and/or the step of adjusting the area of the hemostatic element 4.
  • the hemostatic patch of the present invention is used to compress the arterial blood sampling needle hole, and at this time, a relatively large pressure is required to compress the bleeding.
  • the protective cover of the hemostatic patch is peeled off first, the spring extends a certain distance from the round hole, the hemostatic element 4 is aligned with the pinhole, and then the entire hemostatic patch is glued to the target site. After 10-20 minutes, the hemostatic patch is removed , Complete hemostasis.
  • the process of use may also include the step of removing the hemostatic element 4 to adjust the pressure and/or the step of adjusting the area of the hemostatic element 4.
  • a timer can also be used to automatically start timing, automatically set the compression time, and remind the user to stop bleeding.

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Abstract

一种止血贴，包括：第一层状元件（1）；第二层状元件（2），具有第一表面和第二表面，第一表面与第一层状元件（1）连接，第二表面上设置有粘接材料，该第二层状元件（2）上设置有通孔；压力施加元件（3），其设置在通孔内，且一端与第一层状元件（1）连接，另一端与止血元件（4）连接；以及止血元件（4）；其中，在止血贴处于工作状态时止血元件（4）基本上位于通孔中。该止血贴能够与待止血部位及其周围紧密贴合而没有间隙，能够提供更大的粘附力且有利于小型化。

Description

止血贴 技术领域
本发明涉及一种止血贴，属于医疗器械领域，具体涉及一种一次性压力止血贴。
背景技术
动静脉采血是常见的检查项目。采血后针孔往往需要患者自己或者别人用棉签、棉球等按压止血。按压不到位时容易发生皮下淤血、甚至感染。若是婴幼儿采血后哭闹，按压止血更为困难。若是在寒冷的冬季，长时间按压裸露肢体，还有可能造成着凉感冒。
再者，在日常生活中，皮肤的磕碰、受损出血，也需要压力止血，而目前市面上常用的创可贴、伤口敷贴等起不到这样的作用。
为克服这些缺陷，人们研发了各种各样的弹性压力止血贴。例如，中国专利申请号为200620074135.3的专利公开了一种人体静脉针孔止血胶贴，其中在医用胶布上粘结有一弹性吸水体。中国专利申请号为201820133673.8的专利公开了一种压迫止血贴，其中止血贴本体从上至下依次包括连接部、弹性囊和止血棉。中国专利申请号为201510066229.X的专利公开了一种压力可调的止血贴，其通过旋转按压栓来调节压力。此外，还有一些止血贴结构复杂，操作麻烦，增加了制造成本和使用成本。
上述的止血贴在一定程度上克服了一些缺陷，但仍存在以下的一个或多个缺点：
1、弹性压力体突出于基带，使用时在弹性压力体周围的基带和皮肤之间存在一定空隙，基带不能平整地粘贴在皮肤上，容易造成基带和人体皮肤分离，影响止血效果和/或产品的小型化；
2、压力固定，不能针对不同部位、不同类型伤口进行压力调节，适用性差；
3、按压时间不能控制，有些部位或有些患者不能长时间受压，否则存 在组织发生缺血坏死的风险，安全性差；
4、产品结构复杂，操作复杂，体积大，使用体验差，成本高。
因此，有必要研究一种止血贴来解决上述的一个或多个技术问题。
发明内容
为了解决现有技术中的一个或多个技术问题，本发明提供一种止血贴，其特征在于包括：
第一层状元件，具有第一厚度；
第二层状元件，具有第二厚度且具有第一表面和第二表面，所述第一表面与第一层状元件连接，所述第二表面上设置有粘接材料，该第二层状元件上设置有通孔；
可伸缩的压力施加元件，其设置在所述通孔内，且一端与第一层状元件连接，另一端与下述止血元件连接；以及
止血元件；
其中，在止血贴处于工作状态时所述止血元件基本上位于所述通孔中。
该止血贴能够与待止血部位及其周围紧密贴合而没有间隙，能够提供更大的粘附力且有利于小型化
根据本发明另一方面，所述压力施加元件包括可伸缩的弹性元件。
根据本发明又一方面，所述压力施加元件包括弹簧。
根据本发明又一方面，所述第一层状元件和第二层状元件一体成型。
根据本发明又一方面，所述止血贴还包括保护元件，该保护元件可分离地与第二层状元件的第二表面连接。
根据本发明又一方面，所述保护元件为保护隔离罩。
根据本发明又一方面，所述止血贴包括依次层叠的且可分离的两个或多个止血元件，两个或多个止血元件具有相同面积的接触表面或者具有不同面积的接触表面。
根据本发明又一方面，所述两个或多个止血元件的接触表面从上至下依次减小。
根据本发明又一方面，所述两个或多个止血元件上设置有周向分割线。
根据本发明又一方面，所述止血贴优选为圆形、方形或心形。
根据本发明又一方面，所述保护元件上优选设置有突出部分。
根据本发明又一方面，所述止血元件和压力施加元件优选与通孔的内表面之间存在预定间隙。
根据本发明又一方面，所述止血贴优选还包括定时器和警示单元。
根据本发明又一方面，所述定时器和所述第一层状元件优选一体设置。
根据本发明又一方面，所述止血贴优选还包括压力感测单元和时间设定单元，所述时间设定单元根据压力感测单元感测的压力大小来设定压迫止血时间。
根据本发明又一方面，所述止血贴优选为一次性止血贴。
根据本发明又一方面，所述定时器根据压力感测单元感测的压力位于预定范围内时自动开始计时。
根据本发明又一方面，所述第二层状元件的第二厚度优选可调整，所述第二层状元件优选包括两个或多个可分离的层叠单元。
根据本发明又一方面，还提供了一种止血贴，其特征在于由以下元件组成：
第一层状元件；
第二层状元件，具有第一表面和第二表面，所述第一表面与第一层状元件连接，所述第二表面上设置有粘接材料，该第二层状元件上设置有通孔；
压力施加元件，其设置在所述通孔内，且一端与第一层状元件连接，另一端与下述止血元件连接；
止血元件；以及
保护元件，该保护元件可分离地与第二层状元件的第二表面连接；
其中，在止血贴处于工作状态时所述止血元件基本上位于所述通孔中。
与现有技术相比，本发明具有以下一个或多个技术效果：
1)止血元件工作期间容纳在通孔中而不会突出于第二层状元件的第二表面，止血贴与皮肤紧密贴合，能够提供更大的粘接力，同时有利于粘接面积以及产品的小型化；
2)产品结构简单，制造工艺简单，成本低；
3)可实现单位面积上的压力调节，调节元件和调节方法简单，使用体验更好；
4)可实现定时报警提醒，自动设定定时时间或按压时间；
5)可伸缩弹性元件在重力和/或弹力作用下能够使得止血元件伸出通孔预定长度，有利于使用者将止血元件对准待止血位置。
附图说明
为了能够理解本发明的上述特征的细节，可以参照实施例，得到对于简要概括于上的发明更详细的描述。附图涉及本发明的优选实施例，并描述如下：
图1为根据本发明一种优选实施例的止血贴结构断面图；
图2为图1中的止血贴移除保护元件后的结构示意图；
图3为图2中的止血贴的工作状态示意图；
图4为根据本发明一种优选实施例的第一层状元件示意图；
图5为根据本发明一种优选实施例的第二层状元件示意图；
图6为根据本发明一种优选实施例的止血元件示意图；
图7为根据本发明另一优选实施例的止血贴结构(移除保护元件后)断面图；
图8为根据本发明又一优选实施例的止血贴结构(移除保护元件后)断面图；
图9是根据本发明又一优选实施例的止血贴的止血元件结构示意图；
图10是根据本发明又一优选实施例的止血贴的第二层状元件示意图。
具体实施例
现在将对于各种实施例进行详细说明，这些实施例的一或更多个实例分别绘示于图中。各个实例以解释的方式来提供，而非意味作为限制。例如，作为一个实施例的一部分而被绘示或描述的特征，能够被使用于或结合任一其他实施例，以产生再一实施例。本发明意在包含这类修改和变化。
在以下对于附图的描述中，相同的参考标记指示相同或类似的部件。一 般来说，只会对于个别实施例的不同之处进行描述。除非另有明确指明，否则对于一个实施例中的部分或方面的描述也能够应用到另一实施例中的对应部分或方面。
参见图1，其示出了根据本发明一种优选实施例的止血贴结构断面图。该止血贴包括：第一层状元件1，具有第一厚度；第二层状元件2，具有第二厚度且具有第一表面和第二表面，所述第一表面与第一层状元件1连接，所述第二表面上设置有粘接材料，该第二层状元件2上设置有通孔；可伸缩的压力施加元件3，其设置在所述通孔内，且一端与第一层状元件1连接，另一端与下述止血元件4连接；以及止血元件4。
优选地，第二厚度大于第一厚度。第一厚度可根据压力施加元件3施加在第一层状元件1上的力的大小来确定。第二厚度可根据压缩状态下的压力施加元件3的长度以及止血元件的厚度来共同确定。
参见图3，图3为止血贴的工作状态示意图。优选地，在止血贴处于工作状态时所述止血元件4基本上位于所述通孔中。有利地，止血贴基本上不会从第二层状元件2的第二表面突出，这有利于该第二表面与皮肤8平整地贴合，提供了稳定的粘接力。在提供相同的粘接力的情形下，本发明需要更小的粘合面积，这有利于止血贴的小型化。与之相反的是，现有技术中的止血贴都包括大尺寸的长条形基带或粘接带。
需要说明的是，这里的“止血元件4基本上位于所述通孔中”可以理解为止血元件4的接触表面与第二层状元件2的第二表面基本位于同一平面内，这样既能实现压力的施加，又能确保止血元件4基本不会从第二层状元件2的第二表面突出。同时，这里的术语“基本上”也包括施加的压力大时，较软的待止血部位可能会在压力下存在轻微的移位，从而止血元件4轻微地突出于第二层状元件2的第二表面的情形。可以理解的是，当止血元件4基本上位于所述通孔中时，第二层状元件2的第二表面能够平整地贴合到待止血部位的周围。
参见图2，图2为止血贴移除保护元件5后的结构示意图。该压力施加元件3可以在移除保护元件5后在重力作用下伸长一定距离。由于压力施加元件3伸出通孔一定距离，因而使用者可以方便地看到止血元件4的位置， 而不会受到第一和第二层状元件2的遮挡，有利于定位止血元件4到预定目标，反之则不然。
当安装保护元件5后压力施加元件3处于自然伸长状态或者一定的压缩状态。可以理解的是，当安装保护元件5后压力施加元件3处于一定的压缩状态时，有利于实现止血贴的小型化和便携性。
根据另一优选实施例，所述压力施加元件3包括可伸缩的弹性元件或类似物。
根据本发明又一优选实施例，所述压力施加元件3包括弹簧或类似物。
根据本发明又一优选实施例，所述第一层状元件1和第二层状元件2一体成型。当述第一和第二层状元件2一体成型时，可以直接在其中设置凹孔用作第二层状元件2上的通孔，这样可以减少制造工序，减少成本。
根据本发明又一优选实施例，参见图1，所述止血贴还包括保护元件5，该保护元件5可分离地与第二层状元件2的第二表面连接。所述保护元件5例如为保护隔离罩。该保护隔离罩可以形成为带有下周沿的帽子的形状，该下边沿粘接在第二层状元件2的第二表面上，突出的帽体包围止血元件4和弹簧。
参见图4，图4为根据本发明一种优选实施例的第一层状元件1示意图。第一层状元件1优选为圆形，但并不限于此，例如还可以为方形、心形、长方形、椭圆形、多边形等等。圆形、方形或心形的第一层状元件1有利于止血贴的小型化。第一层状元件1具有相比于第二层状元件2更小的厚度。
参见图5，图5为根据本发明一种优选实施例的第二层状元件2示意图。该第二层状元件2优选为中心带有通孔的圆柱体，但并不限于此，例如还可以为立方体、心形柱体、长方体、椭圆柱体、多边形柱体等等。第二层状元件2例如可以与第一层状元件1采用相同的材料制作，也可以采用不同的材料制作。
参见图6，图6为根据本发明一种优选实施例的止血元件4示意图。该止血元件4优选为圆形，但并不限于此，例如还可以为方形、心形、长方形、椭圆形、多边形等等。有利地，圆形止血元件4有利于用来调节压力大 小。止血元件4的直径例如可以大于弹簧的直径，但小于通孔的直径，但并不限于此。止血元件4的直径例如也可以等于或小于弹簧的直径。
参见图7，图7为根据本发明另一优选实施例的止血贴结构(移除保护元件5后)断面图。该止血贴包括依次层叠的且可分离的两个或多个止血元件4，例如3个或更多个。两个或多个止血元件4具有不同面积的接触表面。术语“接触表面”定义为与待止血部位即目标部位接触的表面。如图7所示，所述3个止血元件4的接触表面从上至下依次减小。更具体地，从弹簧的另一端起依次层叠面积越来越小的止血元件4。最下方面积最小的止血元件4限定了最小的压力施加面积，在一定的弹簧压力下，受力面积越小，受到的压强越大。反之，收到的压强越小。也就是说，通过选择不同面积的止血元件4，可以调整目标位置的单位面积上的压力大小。例如，当需要提供最大的压强时，直接使用最下方的止血元件4，此时受力面积最小，弹簧的压缩量最大；当需要提供最小的压强时，移除下面的两个止血元件4仅保留接触面积最大的一个止血元件4，此时受力面积最大，弹簧的压缩量最小。优选地，最小的止血元件4的面积例如为最大止血元件4面积的1/2至1/3,，甚至是1/4。
参见图8，图8为根据本发明又一优选实施例的止血贴结构(移除保护元件5后)断面图。该止血贴包括依次层叠的且可分离的两个或多个止血元件4，例如3个或更多个。两个或多个止血元件4具有相同面积的接触表面。如图8所示，3个止血元件4的接触表面的面积相同。
参见图9，图9是根据本发明又一优选实施例的止血贴的止血元件4结构示意图。该止血元件4上设置有周向分割线7。例如图8中的3个止血元件4的至少之一上设置有一个、两个或更多个周向分割线7。使用者可以根据实际的需要沿着一个或多个周向分割线7轻易地移除止血元件4的一部分，以改变止血元件4的面积大小。优选地，止血元件4的面积可减小到原来的1/2至1/3，甚至是1/4。远离弹簧的两个或更多个止血元件4上优选设置有一个或多个周向分割线7，且最靠近弹簧的一个止血元件4上没有设置分割线，但本发明并不限于此。
再次参见图1，所述保护元件5上优选设置有突出部分6。使用者可以用手捏住该突出部分6容易地移除保护元件5，以将止血元件4取出。所述止血贴优选为圆形、方形或心形。所述止血元件4和压力施加元件3优选与通孔的内表面之间存在预定间隙，以防止止血元件4与第二层状元件2的第二表面粘接。
根据本发明又一优选实施例，所述止血贴优选还包括定时器和警示单元(未示出)。对于静脉采血而言，通常需要较小的压强和大约5-10分钟左右的按压。对于动脉采血而言，通常需要更大的压强和大约15-20分钟左右甚至是更长时间的按压。通过定时器可以设定按压时间，以及时提醒使用者及时停止按压。
优选地，所述定时器和所述第一层状元件1一体设置。这有利于简化产品结构和制造工艺，降低成本。
根据本发明又一优选实施例，所述止血贴优选还包括压力感测单元和时间设定单元，所述时间设定单元根据压力感测单元感测的压力大小来设定压迫止血时间。当感测的压力大于设定的第一阈值时，判断为动脉采血，设定相应的压迫止血时间。当感测的压力位于设定的第一阈值和第二阈值之间时，判断为静脉采血，设定相应的压迫止血时间。例如，压力感测单元设置在弹簧或第一层状元件1上，优选设置在止血元件4上。压力感测单元用于感测止血元件4施加在目标部位的压力大小，来判断例如是静脉采血还是动脉采血，时间设定单元根据判断结果自动设定对应的定时时间或按压时间。静脉采血后所需的止血压力例如对应为10-15mmHg/单位面积，动脉采血后所需的止血压力例如为50-60mmHg/单位面积，本发明不限于此。该智能化的止血贴可适应于高端消费人群。优选地，压力感测单元感测到单位面积上存在预定范围的压力时，启动定时器，开始计时。
根据本发明又一优选实施例，还提供了一种止血贴，该止血贴由以下元件组成：第一层状元件1；第二层状元件2，具有第一表面和第二表面，所述第一表面与第一层状元件1连接，所述第二表面上设置有粘接材料，该第二层状元件2上设置有通孔；压力施加元件3，其设置在所述通孔内，且一端与第一层状元件1连接，另一端与下述止血元件4连接；止血元件4；以 及保护元件5，该保护元件5可分离地与第二层状元件2的第二表面连接；其中，在止血贴处于工作状态时所述止血元件4基本上位于所述通孔中。通过简化结构，可以最大程度地实现止血贴的小型化和便携性，能够适应广大消费者的普遍需求。该止血贴优选为一次性止血贴。
根据本发明又一优选实施例，还提供了一种一次性压力止血贴，其包括第一层状元件1、第二层状元件2、压力施加元件3、止血元件4和保护元件5。第二层状元件2具有第一表面和第二表面，所述第一表面与第一层状元件1连接，所述第二表面上设置有粘接材料，该第二层状元件2上设置有通孔。压力施加元件3设置在所述通孔内，且一端与第一层状元件1连接，另一端与下述止血元件4连接。该保护元件5可分离地与第二层状元件2的第二表面连接。其中，在止血贴处于工作状态时所述止血元件4基本上位于所述通孔中。该止血贴能够与待止血部位及其周围紧密贴合而没有间隙，能够提供更大的粘附力且有利于小型化。
所述第一层状元件1例如为基体，第二层状元件2例如为带孔的粘贴垫片。止血元件4例如为吸水片。所述的基体例如由塑料薄片或非弹性布片等材料制成。粘贴垫片中央位置带有圆孔，第一表面和相应大小的基体相粘贴，第二表面覆有粘胶层。使用时粘胶层和皮肤8平整地紧密粘贴。该垫片例如可由泡沫、塑料或硅胶等材料制成。压力施加元件3优选弹簧，其直径略小于垫片圆孔，弹簧位于圆孔中。弹簧的一端固定在基体上，另一端固定有吸水片，吸水片可由棉片、纱布或海绵等材料制成。吸水片含有止血、止痛和/或消炎等作用的药物成分，弹簧和吸水片在自然状态下，其长度长于垫片厚度，在弹簧完全被压缩时，弹簧和吸水片不高于垫片厚度，即此时完全容纳于垫片圆孔中，这有利于使用时确保垫片和皮肤8完全紧密贴牢。出厂时垫片和吸水片由带凹部的保护罩密封，弹簧处于自由伸展状态或一定的压缩状态，保护罩可由塑料或纸片等材料制成，其边缘或一角被分割为二，使用时方便保护罩从垫片分离。
为了实现目标部位的单位面积上的压力调节，吸水片可多层层叠，需要较大压力时，直接对准伤口使用多层吸水片，需要较小压力时，撕去一层或更多层吸水片后使用。需要最小压力时，只保留最后一层吸水片。
参见图10，图10是根据本发明又一优选实施例的止血贴的第二层状元件结构示意图。如图10所示，所述第二层状元件2的第二厚度是可以调节的。有利地，通过调节第二厚度，可以调节止血贴工作期间可伸缩的压力施加元件例如弹簧的压缩量，进而能够调节施加在止血元件以及待止血部位的压力或压强大小。例如第二层状元件2包括两个、三个或更多的层叠单元。这些层叠单元例如可以通过设置的周向切割线9来分割。可替换地，这些层叠单元通过表面上的粘胶层彼此层叠。在使用时，可以沿着切割线或者粘胶层轻易地去除一个或更多个层叠单元，但不限于此。可选地，也可以增加第二层状元件2的厚度。
为了实现定时报警，在基体的顶面固定有能发声的计时器，可根据按压的部位和伤口类别，设置相应的时间，止血贴粘贴皮肤8后自动启动计时，计时结束后计时器的微型喇叭发出报警音。可替换地，也可以将垫片和弹簧直接固定在计时器上，省去基体，同样能实现上述功能。
根据本发明又一优选实施例，本发明的止血贴用于静脉采血针孔压迫，此时需要较小压力即可完成止血。具体地，首先，将止血贴的保护罩剥离或撕掉，弹簧伸出圆孔一定距离，将止血元件4对准针孔，然后将整个止血贴粘接在目标部位上，倒计时5到10分钟后报警，除去止血贴，完成止血。有利地，使用过程中还可以包括移除止血元件4以调节压力的步骤和/或调节止血元件4的面积的步骤。
根据本发明又一优选实施例，本发明的止血贴用于动脉采血针孔压迫，此时需要较大压力压迫止血。具体地，先将止血贴的保护罩剥离，弹簧伸出圆孔一定距离，将止血元件4对准针孔，然后将整个止血贴粘接在目标部位上，10-20分钟后，除去止血贴，完成止血。有利地，使用过程中还可以包括移除止血元件4以调节压力的步骤和/或调节止血元件4的面积的步骤。有利地，还可通过定时器自动启动计时、自动设置压迫时间和提醒用户止血完成。
虽然前述内容是关于本发明的实施例，但可在不背离本发明的基本范围的情况下，设计出本发明其他和更进一步的实施例，本发明的范围由下列的权利要求确定。
上述实施例仅为本发明的较佳实施例而已，并不用以限制本发明，这些实施例中不互相违背的技术特征可彼此结合。凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。

Claims (10)

  1. 一种止血贴，其特征在于包括：
    第一层状元件，具有第一厚度；
    第二层状元件，具有第二厚度且具有第一表面和第二表面，所述第一表面与第一层状元件连接，所述第二表面上设置有粘接材料，该第二层状元件上设置有通孔；
    可伸缩的压力施加元件，其设置在所述通孔内，且一端与第一层状元件连接，另一端与下述止血元件连接；以及
    止血元件；
    其中，在止血贴处于工作状态时所述止血元件基本上位于所述通孔中。
  2. 根据权利要求1所述的止血贴，其特征在于所述压力施加元件包括可伸缩的弹性元件。
  3. 根据权利要求2所述的止血贴，其特征在于所述压力施加元件包括弹簧。
  4. 根据权利要求1-3任一项所述的止血贴，其特征在于所述第一层状元件和第二层状元件一体成型。
  5. 根据权利要求1-3任一项所述的止血贴，其特征在于还包括保护元件，该保护元件可分离地与第二层状元件的第二表面连接。
  6. 根据权利要求5所述的止血贴，其特征在于所述保护元件为保护隔离罩。
  7. 根据权利要求5所述的止血贴，其特征在于所述止血贴包括依次层叠的且可分离的两个或多个止血元件，两个或多个止血元件具有相同面积的接触表面或者具有不同面积的接触表面。
  8. 根据权利要求7所述的止血贴，其特征在于所述两个或多个止血元件的接触表面从上至下依次减小。
  9. 根据权利要求7所述的止血贴，其特征在于所述两个或多个止血元件上设置有周向分割线。
  10. 根据权利要求1-9任一项所述的止血贴，其特征在于所述第二层状元件的第二厚度优选可调整；所述第二层状元件优选包括两个或多个可分离的层叠单元；所述止血贴优选为圆形、方形或心形；所述保护元件上优选设置有突出部分；所述止血元件和压力施加元件优选与通孔的内表面之间存在预定间隙；所述止血贴优选还包括定时器和警示单元；所述定时器和所述第一层状元件优选一体设置；所述止血贴优选还包括压力感测单元和时间设定单元，所述时间设定单元根据压力感测单元感测的压力大小来设定压迫止血时间；所述定时器根据压力感测单元感测的压力位于预定范围内时自动开始计时；所述止血贴优选为一次性止血贴。
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