WO2022000612A1 - 一种止血扣 - Google Patents

一种止血扣 Download PDF

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Publication number
WO2022000612A1
WO2022000612A1 PCT/CN2020/103254 CN2020103254W WO2022000612A1 WO 2022000612 A1 WO2022000612 A1 WO 2022000612A1 CN 2020103254 W CN2020103254 W CN 2020103254W WO 2022000612 A1 WO2022000612 A1 WO 2022000612A1
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WO
WIPO (PCT)
Prior art keywords
hemostatic
button
suture
main body
buckle
Prior art date
Application number
PCT/CN2020/103254
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English (en)
French (fr)
Inventor
厉凤琪
刘长星
Original Assignee
上海拓舜医疗科技有限公司
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Publication of WO2022000612A1 publication Critical patent/WO2022000612A1/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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
    • A61B17/823—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage for the sternum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • 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

Definitions

  • the invention relates to the technical field of medical devices, in particular to a hemostatic device, in particular to a hemostatic button pre-installed on a suture thread or a suture wire.
  • a second thoracotomy must be urgently performed to stop bleeding. 1% or so.
  • the reasons for secondary thoracotomy for hemostasis after operation include active bleeding or oozing of sternal incision, periosteum and medullary cavity, wire thread, internal thoracic artery vascular bed, intercostal muscles, intercostal vessels, and rib stump.
  • Open cardiothoracic surgery generally uses a median sternum incision or an intercostal incision.
  • the median sternum incision needs to saw the entire sternum.
  • a needle wire is usually used to suture the left and right incised sternums and then tie them for fixation.
  • the direct threading of the sternal suture wire needs to use a large force, which is difficult.
  • the suture position needs to be moved outward through the intercostal muscles on both sides of the sternum.
  • Steel wire but there are internal thoracic artery vascular beds on both sides of the inner side of the sternum.
  • the steel wire After the steel wire is tightened, it may injure the internal thoracic artery, causing blood vessel perforation or rupture and bleeding.
  • the diameter of the steel needle is generally larger than that of the steel wire, and bleeding from the eye of the needle is more common. This type of bleeding is relatively hidden, and after the chest is closed, the external drainage of the chest cavity or mediastinum will increase after the operation. In severe cases, it is necessary to open the chest again to stop the bleeding.
  • the Chinese utility model patent with the patent publication number CN202714884U discloses a medical self-locking titanium wire suture, including a suture and a suture needle, the suture is composed of multiple strands of titanium wire, and one end of the suture is provided with a pentagonal suture Needle, the other end is provided with a locking device.
  • the locking device includes a bottom sheet and a pressing sheet, the bottom sheet is provided with a screw, the pressing sheet passes through the screw, and a nut matched with the screw is arranged above the pressing sheet.
  • the hemostasis method for the eye of acupuncture is mainly through the hemostatic drugs applied on the surface of the suture needle and suture, and there is no other hemostasis measure.
  • the tightening device needs to be fixed on the bone with screws. This fixation mode will cause additional trauma to the patient's body.
  • the material of the suture is titanium wire, and the locking device is made of titanium alloy, and the cost is correspondingly high.
  • Patent publication number CN 106798585 A Chinese invention patent provides a sternal median incision suture and fixation bandage, including a flexible band and a hook-shaped suture needle, made of PEEK material, with a wider force surface and a smaller sternum.
  • the cutting force can effectively reduce the possibility of bone tissue damage and re-fracture caused by cutting the sternum.
  • the bandage is wide and requires pre-punching of the sternum to be sutured, or still requires puncturing through the intercostal space on both sides of the parasternal side. The former is more traumatic to the patient and time-consuming to operate, while the latter still does not solve the corresponding bleeding problem.
  • the Chinese invention patent with the patent publication number CN 110123428 A provides a quick-release sternum closure fixer.
  • a tensioning mechanism for forcing the two elastic claws to move towards each other is set between the locking wheel and the two elastic claws.
  • the two elastic claws can be forced back to the initial state by rotating the locking wheel, and the sternum closure fixer can be opened smoothly and quickly.
  • the method of use is simple , the controllability is strong.
  • the present invention provides a pre-installed suture or suture
  • the hemostatic buckle on the steel wire has the advantages of reliable buckle, simple structure, simple operation, economical and practical, and can effectively prevent the problem of bleeding at the suture line or the suture wire in the intercostal space of the thorax.
  • a hemostatic button comprising a hemostatic button base, a hemostatic button main body and a top button, wherein: the upper surface of the hemostatic button base is in the shape of a conical protrusion, allowing a suture or a suture wire to pass through, and is used for contacting the intercostal needle eye and compressing the needle eye , effectively stop bleeding;
  • the main body of the hemostatic button is connected with the base of the hemostatic button, the main body of the hemostatic button includes a sheath main body and a limiting device, the sheath main body is a hollow structure, and the hollow structure allows sutures or suture steel to pass through ;
  • the limiting device is arranged on the main body of the sheath tube; and a top buckle, the top buckle is a hollow structure, which is used to cooperate with the limiting device to limit the position, and then adjust the hemostatic buckle when using the hemostatic buckle
  • the distance between the top button and the base of the hemostatic button is such that the base of the hemostatic button and the
  • the hemostatic button main body further comprises a sheath tube top, which is arranged on the top end of the hemostatic button main body, and the sheath tube top is a slope-shaped surface.
  • the top of the sheath tube is a slope-like surface, the main body of the hemostatic buckle can be easily pushed from the inside of the thorax through the intercostal soft tissue along the pinhole and out of the thoracic cavity, which reduces the difficulty of the doctor's operation and relieves the pain of the patient.
  • the shape of the edge contour of the upper surface of the hemostatic buckle base is one of the following shapes: circle, ellipse, rectangle, and square. As long as the upper surface of the hemostatic buckle base ensures sufficient contact area with the intercostal tissue, it can better fit the intercostal tissue and reduce the secondary trauma to the intercostal tissue.
  • a hemostatic material is attached to the upper surface of the base of the hemostatic button.
  • the hemostatic material can stop the bleeding in time and prevent cardiac tamponade.
  • the limiting device is a one-way tooth structure or a threaded structure.
  • the top buckle can only perform one-way movement on the limiting device. When the top buckle reaches the target position, it can be snapped and fixed with the limiting device to achieve the purpose of limiting.
  • the hemostatic button base and the hemostatic button main body are integral structures.
  • the integrated structure can effectively smooth the connection parts, reduce the damage to the human body at the connection, and the connection is more secure to prevent the two from being separated.
  • the material of the hemostatic button is a degradable material.
  • the degradable material includes polyglycolide, polylactic acid, glycolide-lactide copolymer, and polycaprolactone.
  • the hemostatic buckle is used with a handle and a pusher during use, the handle is used to pull the body of the hemostatic buckle upward, and the pusher is used to press the top buckle to a target position.
  • a sternum suture assembly comprising two hemostatic buckles, sutures or suture wires and two suture needles according to claim 1; each end of the sutures or suture wires starts from the base of the hemostatic buckle
  • the main body of the hemostatic button is penetrated; the two ends of the suture thread or the suture steel wire are respectively connected with a suture needle, and the top of each sheath tube is respectively close to the tail of each suture needle.
  • the tightening method is not affected by the distance between the eye of the needle.
  • Each hemostatic buckle can effectively compress the eye of the needle.
  • the soft tissue around the buckle can effectively compress and stop bleeding.
  • the structure is simple, flexible and integral. The cost is economical and practical.
  • the use method of the sternal suture assembly includes the following steps: (1) passing the suture needle at one end of the suture assembly through the intercostal muscle on one side of the sternum from the inside of the thorax to the outside of the thorax, and attaching the hemostatic button at the tail of the suture needle The main body is pushed along the needle hole from the inside of the thorax through the intercostal soft tissue and out of the thorax; (2) the suture needle at the other end of the suture assembly also passes through the other side of the sternum from the inside of the thorax to the outside of the thorax.
  • the beneficial effect of the present invention is that the overall structure of the hemostatic button of the present invention only includes the hemostatic button main body and the top button, and the structure is simple.
  • the inside of the hemostatic button body can allow the used suture or suture wire to pass through it.
  • different lengths of tightening adjustment can be performed between the hemostatic button body and the top button according to the actual needs of a single bleeding point to achieve compression hemostasis, and the tightening method It is not affected by the distance of the needle eye, and the operation is flexible.
  • the hemostatic button is pre-installed on the commonly used surgical suture or suture wire.
  • the suture or suture wire in the eye of the needle is covered with the main sheath of the hemostatic button, so as to avoid the suture or suture wire directly contacting the soft tissue when tightening. Injuries such as strangulation.
  • the hemostatic buckle material can be selected from ordinary medical polymer materials or fully degradable materials, and the overall cost is economical and practical.
  • FIG. 1 is a schematic diagram of the overall structure of a hemostatic buckle according to an embodiment of the present invention.
  • FIG. 2 is a schematic diagram of the tightening and use of a hemostatic buckle according to an embodiment of the present invention
  • FIG. 3 is a schematic diagram of a suture assembly according to an embodiment of the present invention.
  • FIG. 4 is a schematic diagram of a sternum suture operation performed by a hemostatic button according to an embodiment of the present invention
  • Fig. 5 is the schematic diagram of the special scissors applied in the embodiment of the present invention.
  • hemostatic button 1 hemostatic button, 2 handle, 3 pusher, 4 suture or suture wire, 5 stitches, 10 hemostatic button body, 20 top button, 101 sheath body, 102 hemostatic button base, 103 sheath top, 104 Limiting device, the upper surface of the 105 hemostatic buckle base.
  • the present invention provides a hemostatic button pre-installed on a suture or suture wire.
  • the overall structure of the hemostatic button includes a hemostatic button base 102 , a hemostatic button main body 10 and a top button 20 .
  • the outer surface of the base 102 of the hemostatic button is smooth, allowing sutures or suture wires to pass through, and the upper surface 105 of the base 105 is in the shape of a conical protrusion, and the surface is smooth, which is used for contacting with the intercostal needle eye, compressing the needle eye, and effectively stopping bleeding.
  • the shape of the hemostatic button base 102 is similar to a button, and the shape of the edge contour of the upper surface 105 is a circle. In addition, it can also be a rectangle, a rectangle, an ellipse, etc., and the shape can be designed according to needs.
  • a hemostatic material may be attached to the upper surface 105 of the hemostatic buckle base 102.
  • the hemostatic material can stop the bleeding in time and prevent pericardial tamponade.
  • the selected hemostatic materials include hemostatic gauze, instant gauze and the like.
  • the hemostatic button main body 10 is connected with the hemostatic button base 102.
  • the hemostatic button main body 10 and the hemostatic button base 102 have an integrated structure, and the integrated structure can be effectively connected smoothly and reduce the damage to the human body at the connection;
  • the structure will make the connection between the hemostatic button main body 10 and the hemostatic button base 102 more tightly, preventing the two from being separated.
  • the hemostatic button main body 10 and the hemostatic button base 102 may also adopt a split structure, as long as the connection is smooth and fastened.
  • the hemostatic buckle body 10 includes a sheath body 101 , a sheath tip 103 and a limiting device 104 .
  • the sheath tube main body 101 is an inner hollow sheath tube, and the inner diameter of the sheath tube main body 101 is designed to allow the used suture thread or suture wire to pass therethrough.
  • the sheath tube top 103 has a sloped surface, so that the sheath tube body 101 can be easily pushed along the needle hole from the inside of the thorax through the intercostal soft tissue and out of the thorax. Alleviate patient pain.
  • the sheath body 101 is provided with a limiting device 104 for cooperating with the top buckle 20 to achieve the purpose of limiting.
  • the limiting device 104 is a one-way locking tooth structure.
  • the top buckle 20 passes through the top end 103 of the sheath to reach the limiting device 104, the top buckle 20 can only move in one direction on the limiting device 104.
  • the top buckle 20 reaches the target position, the top buckle 20 can be snapped and fixed with the limiting device 104 to achieve the purpose of limiting.
  • the limiting device 104 adopts a one-way locking tooth structure.
  • the limiting device 104 may also adopt a structure such as a threaded structure that can achieve the limiting purpose.
  • the top buckle 20 has a hollow structure, and the top buckle 20 can pass through the top end 103 of the sheath tube, and then match with the limiting device 104 to achieve the purpose of limiting.
  • the inner structure of the top buckle 20 is matched with the limiting device 104.
  • the limiting device 104 is a one-way clamping tooth
  • the inner structure of the top buckle 20 has corresponding clamping teeth;
  • the limiting device 104 is a threaded structure,
  • the inner side of the top buckle 20 has a corresponding thread structure.
  • FIG. 2 is a schematic diagram of the tightening use of the hemostatic buckle in the present invention.
  • the locking and fixing of the hemostatic buckle 1 also needs to be used together with three accessories: the handle 2, the pusher 3 and the special scissors (not shown in the figure).
  • the handle 2 is used to lift the hemostatic button body upwards, so that the hemostatic button body is easier to pass through the intercostal space, and the pusher 3 is used to press the top button 20 to the target position. Used together with the handle 2 and the pusher 3, on the one hand, the hemostatic buckle is locked more tightly during use, and on the other hand, it prevents the surgeon from slipping the gloves during use, which affects the operation process.
  • the locking and fixing steps of the hemostatic button are as follows: (1) the hemostatic button main body 10 relies on the slope-shaped surface of the sheath tube top 103 to be pushed out of the thoracic cage through the intercostal soft tissue, and the hemostatic button base 102 remains in the thoracic cage; (2) The top buckle 20 is snapped on the limiting device 104 extending out of the thorax, and then the pusher 3 is passed through the top 103 of the hemostatic buckle sheath and placed above the top buckle 20, and the handle 2 is stuck on the limit of the hemostatic buckle.
  • the hemostatic button base 102 is close to the tissue with the needle eye, and can be compressed to stop bleeding.
  • the hemostatic button base 102 is attached with a hemostatic material, which can stop bleeding in time and prevent pericardial tamponade.
  • the top buckle 20 can move downward to adjust the position. Therefore, the design of the top buckle in the present invention enables the hemostatic buckle to adapt to patients of different sizes; when the top buckle 20 reaches the target position, stop applying external force to it. , due to the matching structure of the top buckle 20 and the limiting device 104 , the top buckle 20 will be locked and fixed.
  • the hemostatic buckle in the present invention is easy to operate during the use process, and it can quickly push the top buckle 20 to the target position by using the functions of the handle 2 and the pusher 3;
  • the hemostatic buckle base 102 can press against the soft tissue inside the thorax to prevent the suture or suture wire from directly contacting the soft tissue when tightening, causing secondary strangulation and other injuries, and the hemostatic buckle base 102 can compress the hemostasis and use the hemostatic material to stop the bleeding.
  • the hemostatic button body 10 and the top button 20 can be tightened and adjusted in different lengths according to the actual needs of a single bleeding point, which can adapt to different Body type patients have better adaptability.
  • FIG. 3 is a schematic diagram of a suture assembly according to an embodiment of the present invention, comprising two hemostatic buttons 1 , sutures or suture wires 4 and two suture needles 5 , and two hemostatic button bodies 10 are pre-installed on the sutures or suture wires 4 , each end of the suture or suture wire 4 is penetrated by the hemostatic buckle base 102, and the entire hemostatic button body 10 is pierced by the sheath top 103; the two ends of the suture or suture wire 4 are respectively connected with a seam In the needle 5, the top end 103 of each sheath tube is respectively close to the tail of each sewing needle 5.
  • the two hemostatic buckle main bodies 10 also need to be combined with two top buckles 20 to achieve tightening.
  • FIG. 4 is a schematic diagram of the sternum suture operation performed by the hemostatic button according to the present invention.
  • the steps of using the hemostatic buckle of the present invention to carry out suture operation are as follows:
  • top buckles 20 is clamped on the limiting device 104 on the main body 10 of one of the hemostatic buckles by means of the handle 2, and then the pusher 3 is placed on the top of the top buckle 20 through the top 103 of the sheath tube, and the handle 2 It is stuck on the limiting device 104, one hand pulls the handle, and the other hand uses the pusher 3 to press down the top buckle 20 to further tighten the hemostatic buckle, and then use scissors to cut off the top buckle 20 after finishing the tightening.
  • the hemostatic buckle body 10 is stuck on the limiting device 104, one hand pulls the handle, and the other hand uses the pusher 3 to press down the top buckle 20 to further tighten the hemostatic buckle, and then use scissors to cut off the top buckle 20 after finishing the tightening.
  • the hemostatic buckle of the present invention is tightened, different lengths of the hemostatic buckle main body 10 and the top buckle 20 can be tightened and adjusted according to the actual needs of a single bleeding point, and the soft tissue around the buckle can effectively compress and stop bleeding.
  • the function of the tightening method is not affected by the distance between the needle eyes, and the operation is flexible.
  • the hemostatic buckle main body 10 and the sheath tube base 102 can press against the soft tissue inside the thorax when the suture or suture wire is tightened to achieve compression and hemostasis.
  • the hemostatic material attached to the surface of the sheath tube base 102 can further promote hemostasis.
  • the bleeding point can play a better hemostasis effect and avoid cardiac tamponade.
  • the hemostatic button 1 of the present invention is pre-installed on a common surgical suture or suture wire 4, and the suture or suture wire 4 in the eye of the needle is sheathed with a hemostatic button main body sheath 101 during the operation to prevent the suture or suture wire from being retracted. When it is tight, it directly touches the soft tissue to cause secondary strangulation and other injuries.
  • the structure of the hemostatic button 1 only includes the hemostatic button main body 10 and the top button 20, and the structure is simple.
  • the hemostatic buckle material can be selected from ordinary medical polymer materials or fully degradable materials, and the overall cost is economical and practical.
  • the hemostatic button in the present invention is made of common medical polymer materials or fully degradable materials.
  • the material does not contain metal and will not produce artifacts under X-rays.
  • the optional materials include polyurethane, silicone rubber, polyester fiber, polyethylene pyrrolidone, polyether ether ketone, polymethyl methacrylate, polyvinyl alcohol, polylactic acid, polyethylene, etc.
  • the handle 2 used in the above operation steps can be made by an injection molding process, and the pusher 3 is made of medical metal, which ensures the safety standard of the operation environment.
  • the above materials are more commonly used materials, and the cost is low.

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Abstract

一种止血扣（1），整体结构包括止血扣底座（102）、止血扣主体（10）和顶端扣（20）。止血扣底座（102）的上表面（105）呈圆锥突起状，允许缝合线或缝合钢丝（4）穿过，用于与肋间针眼相接触，压迫针眼；止血扣主体（10）与止血扣底座（102）相连接，止血扣主体（10）包括鞘管主体（101）和限位装置（104），鞘管主体（101）为中空结构，所述中空结构可允许缝合线或缝合钢丝（4）穿过，限位装置（104）设置在所述鞘管主体（101）上；顶端扣（20）为中空结构，其用于与限位装置（104）配合进行限位，进而在使用所述止血扣（1）时调整所述顶端扣（20）与所述止血扣底座（102）之间的距离，使得止血扣底座（102）和顶端扣（20）分别与针眼固定接触。本止血扣（1）卡扣牢靠、结构简单、操作灵活、经济实用，有效防止胸廓内肋间隙穿钢丝处出血问题。

Description

一种止血扣 技术领域
本发明涉及医疗器械技术领域，具体涉及一种止血装置，尤其涉及一种预装在缝合线或缝合钢丝上的止血扣。
背景技术
在心胸外科术后若发现引流管出血多必须紧急行二次开胸止血，其中心内直视手术后出血再手术率约为2％～5％，普胸外科手术术后出血再手术率为1％左右。术后行二次开胸止血的原因包括胸骨切口、胸骨骨膜及骨髓腔、穿钢丝处、胸廓内动脉血管床、肋间肌、肋间血管、肋骨残端部位的活动性出血或渗血。
心胸外科开放性手术一般会用到胸骨正中切口或肋间切口，胸骨正中切口需要将整个胸骨锯开，关闭切口时一般选择带针钢丝把左、右切开的胸骨缝合后捆扎固定。在胸骨缝合时，直接穿胸骨缝合钢丝需要使用较大的力道，具有一定的难度，当遇到胸骨硬度较高的患者，就需采用缝合位置外移通过胸骨两侧的肋间肌进针穿钢丝，但是胸骨内侧面的两侧有胸廓内动脉血管床，钢丝在勒紧后会有可能伤及胸廓内动脉，造成血管穿孔或破裂出血，在心脏手术穿过胸骨等松质骨缝合时，且钢针直径一般大于钢丝直径，针眼渗血较常见，此类出血比较隐匿，而且处于关胸之后，术后往外会造成胸腔或纵膈引流增多，严重者需要再次开胸止血。
专利公开号为CN202714884U的中国实用新型专利公开了一种医用自锁式钛丝缝合线，包括缝合线和缝合针，所述缝合线由多股钛丝构成，缝合线一端设有五棱形缝合针，另一端设有锁紧装置。所述锁紧装置包括底片和压片，所述底片上设置螺丝，所述压片穿过螺丝，在压片上方设置一和螺丝配套的螺母。此方案虽然在使用中较易固定、力学强度好且与人体内组织相容性好，但其中对于针眼止血方式主要是通过缝针与缝线表面涂抹的止血药物，无其他止血措施，其锁紧装置需配合螺钉将其固定于骨头上，此固定模式会对患者的身体产生额外创伤，且该方案中缝合线的材料是钛丝，锁紧装置采用钛合金，其费用 也相应较高。
专利公开号为CN 106798585 A中国发明专利提供了一种胸骨正中切口缝合固定用绑带，包括柔性带和弯钩状缝合针，采用PEEK材料制备，受力面较宽，对胸骨有较小的切割力，能有效减少切割胸骨造成的骨组织损伤和再次骨折的可能性。但是该绑带较宽，需要对所缝合胸骨进行预先打孔，或者仍然需要通过胸骨旁两侧的肋间隙进行穿刺。前者对患者的创伤较大而且操作费时，后者仍然没有解决相应的出血问题。
专利公开号为CN 110123428 A的中国发明专利提供了一种快拆胸骨合拢固定器，在锁紧轮与两弹性爪之间设置了迫使两弹性爪相向运动的拉紧机构，锁紧轮旋转后，在公固定件的弹性爪会由于人体组织的生长失去了回弹力的情况下，可以通过旋转锁紧轮将两弹性爪强迫拉回至初始状态，顺利快速打开胸骨合拢固定器，使用方法简单，可操控性强。该方案虽然替代了胸骨钢丝，避免了对胸骨的切割，但是仍然存在需要二次手术取出，经济费用高的问题。
因此，在实际临床工作中，如何更好的解决对关胸手术中缝合线针眼的出血问题，同时又安全可靠、结构简单、操作方便、经济实用成了需要解决的新的需求方向。
发明内容
为了克服现有技术在心胸外科关胸手术关于缝合线处针眼出血解决方案中易产生结构复杂、操作要求高、额外创伤、费用较高等问题，本发明提供了一种预装在缝合线或缝合钢丝上的止血扣，该止血扣卡扣牢靠、结构简单、操作简单、经济实用，有效防止胸廓内肋间隙穿缝合线或缝合钢丝处出血问题。
本发明所采用的技术方案是：
一种止血扣，包括止血扣底座、止血扣主体和顶端扣，其中：止血扣底座的上表面呈圆锥突起状，允许缝线或缝合钢丝穿过，用于与肋间针眼相接触，压迫针眼，有效进行止血；止血扣主体与止血扣底座相连接，所述止血扣主体包括鞘管主体和限位装置，所述鞘管主体为中空结构，所述中空结构允许缝合线或缝合钢穿过；所述限位装置设置在所述鞘管主体上；以及顶端扣，所述顶端扣为中空结构，其用于与限位装置配合进行限位，进而在使用所述止血扣时调整所述顶端扣与所述止血扣底座之间的距离，使得止血扣底座和顶端扣分别 与针眼贴合接触。此止血扣可根据单个出血点的实际需要进行不同长度的收紧调节，可以适应不同身体状态的患者，具有更好的适应性，操作灵活且结构简单。
作为一个优选，所述止血扣主体还包括鞘管顶端，其设置在止血扣主体的顶端，所述鞘管顶端为斜坡状面。鞘管顶端为斜坡状面时，止血扣主体可以轻易地沿着针孔从胸廓内穿过肋间软组织推送出胸廓外，降低医生的操作难度，并且可以减轻病人痛苦。
作为一个优选，所述止血扣底座的上表面的边线轮廓形状为以下形状其中之一：圆形、椭圆形、长方形、正方形。止血扣底座只要其上表面确保与肋间组织有充分的接触面积即可，使其更能贴合肋间组织，减少对肋间组织的二次创伤。
作为一个优选，所述止血扣底座的上表面附有止血材料。当肋间组织表面出血时，止血材料能及时止血，防止心包填塞。
作为一个优选，所述限位装置为单向齿结构或者螺纹结构。顶端扣在限位装置上只能进行单向运动，当顶端扣到达目标位置后，即可以与限位装置相卡扣固定，达到限位的目的。
作为一个优选，所述止血扣底座和止血扣主体为一体结构。采用一体结构可以有效地平滑连接部分，降低连接处对人体的损害，连接更为紧固，防止两者脱离。
作为一个优选，所述止血扣的材料为可降解材料。
作为一个优选，所述可降解材料包括聚乙交酯、聚乳酸、乙交酯丙交酯共聚物、聚已内酯。
作为一个优选，所述止血扣在使用过程中，配合手柄、推送器使用，所述手柄用于向上提拉止血扣主体，所述推送器用于将顶端扣按压到目标位置。
一种胸骨缝合组件，包括两个权利要求1所述的止血扣、缝合线或缝合钢丝和两个缝针；所述缝合线或缝合钢丝的各端部都是由所述止血扣底座为起点穿入所述止血扣主体；所述缝合线或缝合钢丝的两端分别连接有一个缝针，每个鞘管顶端分别靠近每个缝针尾部。此组件在实际应用中，收紧方式不受针眼间距的影响，每个止血扣都可单独对针眼进行有效压迫，卡扣周围的软组织有效起到压迫止血的作用，结构简单，使用灵活且整体费用经济实用。
作为一个优选，胸骨缝合组件的使用方法，包括以下步骤：(1)将缝合组件一端的缝针由胸廓内向胸廓外方向穿过胸骨一侧的肋间肌，将紧随缝针尾部的止血扣主体随缝针穿出方向，沿着针孔从胸廓内穿过肋间软组织推送出胸廓外；(2)将缝合组件另一端的缝针也由胸廓内向胸廓外方向穿过胸骨另一侧的肋间肌，将紧随缝针尾部的止血扣主体随缝针的穿出方向，沿着针孔从胸廓内穿过肋间软组织推送出胸廓外；(3)将其中一顶端扣借助手柄卡在其中一止血扣主体上的限位装置上，进而将推送器穿过鞘管主体顶端置于顶端扣的上方，将手柄卡在鞘管主体限位装置上，一只手提拉手柄，另一只手使用推送器往下按压顶端扣可以进一步收紧此止血扣，完成收紧后再用剪刀剪去露出顶端扣部分的止血扣主体；(4)按第(3)步相同操作完成另一止血扣的收紧；(5)然后收紧缝合线或缝合钢丝。此组件在使用中，在针眼内的缝合线或缝合钢丝外部套装着止血扣主体鞘管，避免缝合线或缝合钢丝在收紧时直接接触软组织造成二次勒伤等伤害，并且操作过程简单灵活。
本发明的有益效果是，本发明的止血扣整体结构仅包括止血扣主体和顶端扣，结构简单。止血扣主体内部可允许所用缝合线或缝合钢丝从中穿过，在针眼内，止血扣主体与顶端扣之间可根据单个出血点实际需要进行不同长度的收紧调节实现压迫止血，且收紧方式不受针眼间距的影响，操作灵活。止血扣预装在常用手术缝合线或缝合钢丝上，手术中在针眼内的缝合线或缝合钢丝外部套装着止血扣主体鞘管，避免缝合线或缝合钢丝在收紧时直接接触软组织造成二次勒伤等伤害。止血扣材料可选用普通医用高分子材料或全降解材料，整体费用经济实用。
附图说明
下面结合附图和实施例对本发明进一步说明。
图1为本发明实施例的止血扣整体结构示意图；
图2为本发明实施例的止血扣收紧使用示意图；
图3为本发明实施例的缝合组件示意图；
图4为本发明实施例的止血扣进行胸骨缝合手术示意图；
图5为本发明实施例中应用的专用剪刀示意图；
图中：1止血扣，2手柄，3推送器，4缝合线或缝合钢丝，5缝针，10止血扣主体，20顶端扣，101鞘管主体，102止血扣底座，103鞘管顶端，104限位装置，105止血扣底座上表面。
具体实施方式
下面将结合示意图对本发明的具体实施方式进行更详细的描述。根据下列描述，本发明的优点和特征将更清楚。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
参照图1，本发明提供了一种预装在缝合线或缝合钢丝上的止血扣，止血扣的整体结构包括止血扣底座102、止血扣主体10和顶端扣20。
止血扣底座102外表面光滑，允许缝线或缝合钢丝穿过，其上表面105呈圆锥突起状，且表面光滑，用于与肋间针眼相接触，对针眼起到压迫作用，有效进行止血。在本实施例中，止血扣底座102的形状类似纽扣，其上表面105的边线轮廓形状为圆形，除此之外，还可以为矩形、长方形、椭圆形等形状，可以根据需要进行形状设计，只要确保与肋间组织有充分的接触面积即可，使其更能贴合肋间组织，减少对肋间组织的二次创伤。为了达到更好的止血效果，止血扣底座102的上表面105上还可以附有止血材料，当肋间组织表面出血时，止血材料能及时止血，防止心包填塞。所选用的止血材料包括止血纱、速即纱等。
止血扣主体10与止血扣底座102相连接，在本实施例中，止血扣主体10与止血扣底座102为一体结构，采用一体结构可以有效地平滑连接，降低连接处对人体的损害；采用一体结构将使得止血扣主体10和止血扣底座102连接更为紧固，防止两者脱离。止血扣主体10和止血扣底座102之间也可以采用分体式结构，只要其连接处平滑且紧固即可。
止血扣主体10包括鞘管主体101，鞘管顶端103和限位装置104。其中，鞘管主体101为一内部中空的鞘管，鞘管主体101内部直径设计成允许所用的缝合线或缝合钢丝从中穿过。鞘管顶端103呈斜坡状面，使得鞘管主体101可以轻易地沿着针孔从胸廓内穿过肋间软组织推送出胸廓外，鞘管顶端103斜坡状设计可以降低医生的操作难度，并且可以减轻病人痛苦。鞘管主体101上设置有限位装置104，用于与顶端扣20配合使用，达到限位的目的。在本实施例 中，限位装置104为单向卡齿结构，当顶端扣20穿过鞘管顶端103到达限位装置104后，顶端扣20在限位装置104上只能进行单向运动，当顶端扣20到达目标位置后，顶端扣20即可以与限位装置104相卡扣固定，达到限位的目的。在本实施例中，限位装置104采用的是单向卡齿结构，除此之外，限位装置104还可以采用螺纹结构等能实现限位目的的结构。
顶端扣20呈中空结构，顶端扣20可以穿过鞘管顶端103，进而与限位装置104相匹配，达到限位的目的。顶端扣20的内侧结构与限位装置104进行匹配，当限位装置104为单向卡齿时，顶端扣20的内侧结构具有与之对应的卡齿；当限位装置104为螺纹结构时，顶端扣20的内侧具有与之对应的螺纹结构。
图2为本发明中的止血扣收紧使用示意图。在使用中，止血扣1的锁紧固定还需另外配合手柄2、推送器3和专用剪刀(图中未示出)三个配件一起使用。手柄2用于向上提拉止血扣主体，使得止血扣主体更易于从肋间穿出，推送器3用于将顶端扣20按压到目标位置。配合手柄2和推送器3一起使用，一方面使得止血扣在使用过程中锁得更加紧固，另一方面，防止外科医生在使用过程中将手套滑破，影响手术进程。止血扣的锁紧固定步骤如下：(1)止血扣主体10依靠鞘管顶端103的斜坡状面从胸廓内穿过肋间软组织推送出胸廓外，止血扣底座102留在胸廓内；(2)将顶端扣20卡扣在伸出胸廓外的限位装置104上，再将推送器3穿过止血扣鞘管顶端103并置于顶端扣20的上方，将手柄2卡在止血扣的限位装置104上；(3)将止血扣进行锁紧固定，一只手提拉手柄2，另一只手使用推送器3往下按压顶端扣20可以进一步收紧止血扣；(4)收紧止血扣后再用专用剪刀(图中未示出)剪去露出顶端扣部分的止血扣鞘管。此时，止血扣底座102紧靠有针眼的组织，能进行压迫止血，除此之外，止血扣底座102上附有止血材料，能及时止血，防止心包填塞。使用本发明中的止血扣，在钢丝勒紧之后，钢丝不会直接与胸廓接触，而是通过止血扣底座和顶端扣与胸廓进行接触，因此在钢丝勒紧之后，不会伤及胸廓内动脉。顶端扣20在到达目标位置之前，可以向下移动调节位置，因此，本发明中的顶端扣的设计使得止血扣能适应不同体型的患者；当顶端扣20到达目标位置时，停止对其施加外力，由于顶端扣20和限位装置104的匹配结构，顶端扣20将被锁紧固定。
由上述使用过程可知，本发明中的止血扣在使用过程中，操作简单，其利用手柄2和推送器3的作用，能快速将顶端扣20推送到目标位置；在缝合线或 缝合钢丝拉紧时，止血扣底座102可抵住胸廓内侧软组织，避免缝合线或缝合钢丝在收紧时直接接触软组织造成二次勒伤等伤害，且止血扣底座102能压迫止血同时利用止血材料进行止血，能有效控制针眼渗血，防止心包填塞；除此之外，止血扣在收紧后，止血扣主体10与顶端扣20之间可根据单个出血点实际需要进行不同长度的收紧调节，可以适应不同体型的患者，具有更好的适应性。
图3是本发明实施例的缝合组件示意图，包括两个止血扣1、缝合线或缝合钢丝4和两个缝针5，两个止血扣主体10预安装于所述缝合线或缝合钢丝4上，缝合线或缝合钢丝4的各端部都是由止血扣底座102穿入，由鞘管顶端103穿出整个止血扣主体10；所述缝合线或缝合钢丝4的两端分别连接有一个缝针5，每个鞘管顶端103分别靠近每个缝针5尾部，在使用中两个止血扣主体10分别还需要结合两个顶端扣20来实现收紧。
图4为本发明中止血扣进行胸骨缝合手术示意图。在进行胸骨缝合手术时，使用本发明中的止血扣进行缝合手术的步骤如下：
(1)将缝合组件一端的缝针5由胸廓内向胸廓外方向穿过胸骨一侧的肋间肌，将紧随缝针尾部的止血扣主体10随缝针5的穿出方向，依靠鞘管顶端103斜坡状面沿着针孔从胸廓内穿过肋间软组织推送出胸廓外，止血扣底座102留在胸廓内。
(2)将缝合组件另一端的缝针5也由胸廓内向胸廓外方向穿过胸骨另一侧的肋间肌，将紧随缝针5尾部的止血扣主体10随缝针5的穿出方向，依靠鞘管顶端103斜坡状面沿着针孔从胸廓内穿过肋间软组织推送出胸廓外，止血扣底座102留在胸廓内。
(3)将其中一顶端扣20借助手柄2卡在其中一止血扣主体10上的限位装置104上，进而将推送器3穿过鞘管顶端103置于顶端扣20的上方，将手柄2卡在限位装置104上，一只手提拉手柄，另一只手使用推送器3往下按压顶端扣20可以进一步收紧此止血扣，完成收紧后再用剪刀剪去露出顶端扣20部分的止血扣主体10。
(4)按第(3)步相同操作完成另一止血扣的收紧。
(5)然后收紧缝合线或缝合钢丝4。
经上所述，本发明的止血扣在收紧后，止血扣主体10与顶端扣20之间可根据单个出血点实际需要进行不同长度的收紧调节，卡扣周围的软组织有效起到压迫止血的作用，收紧方式不受针眼间距的影响，操作灵活。其中止血扣主体10鞘管底座102在缝合线或缝合钢丝拉紧时可抵住胸廓内侧软组织，实现压迫止血，其次在鞘管底座102表面附有的止血材料可进一步促进止血，对于胸廓内的出血点可以起到更好的止血效果，避免导致心包填塞。
本发明的止血扣1预装在常用手术缝合线或缝合钢丝4上的，手术中在针眼内的缝合线或缝合钢丝4外部套装着止血扣主体鞘管101，避免缝合线或缝合钢丝在收紧时直接接触软组织造成二次勒伤等伤害。
止血扣1结构仅包括止血扣主体10和顶端扣20，结构简单。止血扣材料可选用普通医用高分子材料或全降解材料，整体费用经济实用。
在本发明中的止血扣选用普通医用高分子材料或全降解材料，其材质不含金属，在X射线下不会产生伪影，可选用的材料包括聚氨酯、硅橡胶、聚酯纤维、聚乙烯基吡咯烷酮、聚醚醚酮、聚甲基丙烯酸甲酯、聚乙烯醇、聚乳酸、聚乙烯等。在上述手术步骤中使用的手柄2可以通过注塑工艺制成，推送器3是医用金属制成，保证了手术环境的安全规范。以上材料均为较为常用的材料，成本较低。
以上所述仅是本发明的优选实施例而已，并非用以限定本发明，任何熟悉本专业的技术人员，在不脱离本发明的原理和宗旨的情况下可以对这些实施例进行多种变化、修改、替换和变型，本发明的范围由权利要求及其等同物限定。

Claims (11)

  1. 一种止血扣，其特征在于，包括止血扣底座、止血扣主体和顶端扣，其中：
    止血扣底座的上表面呈圆锥突起状，允许缝合线或缝合钢丝穿过，用于与肋间针眼相接触，压迫针眼；
    止血扣主体与止血扣底座相连接，所述止血扣主体包括鞘管主体和限位装置，所述鞘管主体为中空结构，所述中空结构允许缝合线或缝合钢丝穿过，所述限位装置设置在所述鞘管主体上；以及
    顶端扣，所述顶端扣为中空结构，其用于与限位装置配合进行限位，进而在使用所述止血扣时调整所述顶端扣与所述止血扣底座之间的距离，使得止血扣底座和顶端扣分别与针眼贴合接触。
  2. 根据权利要求1所述的止血扣，其特征在于，所述止血扣主体还包括鞘管顶端，其设置在止血扣主体的顶端，所述鞘管顶端为斜坡状面。
  3. 根据权利要求1所述的止血扣，其特征在于，所述止血扣底座的上表面的边线轮廓形状为以下形状其中之一：圆形、椭圆形、长方形、正方形。
  4. 根据权利要求1所述的止血扣，其特征在于，所述止血扣底座的上表面附有止血材料。
  5. 根据权利要求1所述的止血扣，其特征在于，所述限位装置为单向齿结构或者螺纹结构。
  6. 根据权利要求1所述的止血扣，其特征在于，所述止血扣底座和止血扣主体为一体结构。
  7. 根据权利要求1所述的止血扣，其特征在于，所述止血扣的材料为可降解材料。
  8. 根据权利要求7所述的止血扣，其特征在于，所述可降解材料包括聚乙交酯、聚乳酸、乙交酯丙交酯共聚物、聚已内酯。
  9. 根据权利要求1所述的止血扣，其特征在于，所述止血扣在使用过程中，配合手柄、推送器使用，所述手柄用于向上提拉止血扣主体，所述推送器用于将顶端扣按压到目标位置。
  10. 一种胸骨缝合组件，其特征在于，包括两个权利要求1所述的止血扣、缝合线或缝合钢丝和两个缝针；
    所述缝合线或缝合钢丝的各端部都是由所述止血扣底座为起点穿入所述止血扣主体，所述缝合线或缝合钢丝的两端分别连接有一个缝针。
  11. 权利要求10的胸骨缝合组件的使用方法，其特征在于，包括以下步骤：
    (1)将缝合组件一端的缝针由胸廓内向胸廓外方向穿过胸骨一侧的肋间肌，将紧随缝针尾部的止血扣主体随缝针的穿出方向，沿着针孔从胸廓内穿过肋间软组织推送出胸廓外；
    (2)将缝合组件另一端的缝针也由胸廓内向胸廓外方向穿过胸骨另一侧的肋间肌，将紧随缝针尾部的止血扣主体随缝针的穿出方向，沿着针孔从胸廓内穿过肋间软组织推送出胸廓外；
    (3)将其中一顶端扣借助手柄卡在其中一止血扣主体上的限位装置上，进而将推送器穿过鞘管主体顶端置于顶端扣的上方，将手柄卡在止血扣主体的限位装置上，一只手提拉手柄，另一只手使用推送器往下按压顶端扣可以进一步收紧此止血扣，完成收紧后再用剪刀剪去露出顶端扣部分的止血扣主体；
    (4)按第(3)步相同操作完成另一止血扣的收紧；
    (5)收紧缝合线或缝合钢丝。
PCT/CN2020/103254 2020-07-02 2020-07-21 一种止血扣 WO2022000612A1 (zh)

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