WO2020057113A1 - 伤口闭合器 - Google Patents

伤口闭合器 Download PDF

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Publication number
WO2020057113A1
WO2020057113A1 PCT/CN2019/082548 CN2019082548W WO2020057113A1 WO 2020057113 A1 WO2020057113 A1 WO 2020057113A1 CN 2019082548 W CN2019082548 W CN 2019082548W WO 2020057113 A1 WO2020057113 A1 WO 2020057113A1
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WO
WIPO (PCT)
Prior art keywords
wound
window
negative pressure
module
wound closure
Prior art date
Application number
PCT/CN2019/082548
Other languages
English (en)
French (fr)
Inventor
张新平
Original Assignee
上海锦辰医药科技有限公司
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 上海锦辰医药科技有限公司 filed Critical 上海锦辰医药科技有限公司
Priority to EP19861310.1A priority Critical patent/EP3834746A4/en
Priority to SG11202102622TA priority patent/SG11202102622TA/en
Priority to AU2019343653A priority patent/AU2019343653B2/en
Priority to US17/278,307 priority patent/US20210267597A1/en
Priority to KR1020217008523A priority patent/KR20210061351A/ko
Priority to JP2021540350A priority patent/JP2022502220A/ja
Publication of WO2020057113A1 publication Critical patent/WO2020057113A1/zh
Priority to IL281543A priority patent/IL281543A/en

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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
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/085—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound with adhesive layer
    • 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
    • A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B2017/081—Tissue approximator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/085—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound with adhesive layer
    • A61B2017/086—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound with adhesive layer having flexible threads, filaments, laces or wires, e.g. parallel threads, extending laterally from a strip, e.g. for tying to opposing threads extending from a similar strip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B2017/088—Sliding fasteners
    • 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
    • A61F2013/00451—Plasters use for surgical sutures, e.g. butterfly type

Definitions

  • the invention relates to a wound closure device, in particular to a wound closure device in the field of skin wound suture.
  • skin tissue is the most basic and important barrier closure structure inside and outside the human body.
  • Skin tissue includes the epidermis, dermis, and subcutaneous layers of the skin.
  • this barrier When this barrier is damaged by surgical cutting or trauma, it must be sutured surgically so that the free skin margin of the wound can be restored to the original layered assemblage as soon as possible according to the original anatomy of the skin, and the skin structure of the original skin will be restored by regeneration of the skin tissue.
  • Physiological function In order to promote the layered butt fusion of the wound free skin margin, the precise alignment and leveling of the wound skin margin in the horizontal axial direction and the vertical axial direction are particularly important for wound healing, and are the basis of wound physiological regeneration healing.
  • a wound exudate absorption module for example, a wound hemostasis module, a wound antibacterial and antibacterial module, a sensor module for collecting wound information, and promotion of wound healing can be provided.
  • Cell tissue regeneration module etc., will surely accelerate wound physiological healing and improve the quality of wound physiological healing.
  • the following disadvantages are unavoidable: First, the lack of an independent and efficient and timely cleaning of wound oozing and oozing modules, a large number of oozing accumulation secondary wound infections , Exudate accumulation caused the suture device to fall off, wound suture failure, delayed wound healing, wound non-healing. Second, the lack of a continuous and effective vertical alignment force mechanism or alignment reference module, can not ensure the wound skin edge in the vertical axial alignment flat, can not complete the skin layer precise alignment, a large number of misalignment healing (such as step-like errors) Layer healing, sacral healing, poor scar body healing).
  • the wound healing area lacks an effective wound hemostasis module, wound bacteriostatic module, tissue regeneration promotion module and other continuous effects, or there is no guarantee that the above modules are reliable and continuous and directly act on the wound healing area, and its actual efficiency is extremely effective. Low or actually missing. It is difficult to achieve good physiological regenerative wound healing.
  • the technical problem to be solved by the present invention is to provide a more effective wound closure device.
  • a complete or independent undisturbed treatment unit is constructed, so that the functional modules required for wound treatment can be reliably Sustained, direct and continuous action on the wound healing area, effectively avoiding the accumulation of exudate, causing the suture device to fall off, secondary wound infection, wound suture failure, healing of wound malformations, and achieving better wound physiological regeneration and healing.
  • a wound closure device comprising a window, a retractor and a fixer, the window comprising a window body wall and a window top wall, and the drawer device is provided On both sides of the window, one end of the coupler is connected to the holder, and the other end is connected to the window.
  • the bottom surface of the holder facing the skin is provided with a fixed adhesive layer.
  • a window that can be opened and closed is provided on the top wall of the window.
  • an alignment reference support module is provided in the window, and a bottom surface of the alignment reference support module facing the wound is a rigid reference plane.
  • first area negative pressure sealing film and a second area negative pressure sealing film wherein the first area negative pressure sealing film and the window body wall form a window negative pressure sealing chamber, and the second The area sealing film forms a peripheral negative pressure sealing chamber with the outer wall of the window and the skin around the wound, and the holder is located in the peripheral negative pressure sealing chamber.
  • the wall of the window body is a circular closed isolation fence.
  • a plastic body is attached to the isolation fence, and the geometry of the plastic body determines the final geometry of the isolation fence.
  • the geometry of the plastic body is prefabricated into a closed loop shape extending a certain distance along the longitudinal axis of the actual wound.
  • top wall of the window is a flexible material and can settle downward under the action of negative pressure.
  • a window that can be opened and closed is provided on the top wall of the window.
  • a window sash is provided on the window. The window sash closes the top wall of the window. The window sash is opened to communicate the internal space of the window with the external space.
  • the puller includes a lock buckle and a ratchet bar, and the lock buckle is connected to the holder.
  • the lock buckle has ratchet teeth.
  • One end of the ratchet bar is connected and fixed to the window, and the other end is inserted into the lock buckle.
  • the drawstring device may be provided as a tie, the tie is folded back at the connection window to form a bent portion, and the bent portion of the tie is provided with a sticking area connected with the surface of the holder and the back of the tie to be fixed .
  • the holder is provided on both sides of the window, and the bottom surface of the holder facing the skin is provided with an adhesive layer, which is fixed on the outer skin surface on both sides of the wound.
  • a base band parallel to the outer wall of the corresponding window is provided on the inner edge of the anchor facing the wound.
  • the functional module is a wound exudate absorption module and / or a wound hemostasis module and / or a wound antibacterial and antibacterial module and / or a wound information acquisition module and / or a cell tissue regeneration module.
  • a negative pressure pipeline which communicates the internal negative pressure sealing chamber and the peripheral negative pressure sealing chamber with the outside.
  • the beneficial effect of the present invention is that a window structure corresponding to the wound skin healing area is creatively set in the wound function healing area where the free skin margin is located in the middle of the wound.
  • the area and the non-functional healing area around the wound achieve an effective, reliable, and stable solid structural isolation. Therefore, it is more effective to ensure that various important treatment modules in the window structure can be more reliable, Stable, direct and continuous action on the wound healing area, give full play to the functional role of the treatment module without bad interference from the outside, and can better promote good physiological healing of the wound.
  • a prefabricated body is set on the window structure, which can further meet the precise customization and effective isolation of the functional healing area of clinical irregular geometric wounds, and further solve the problem of suture of clinical irregular geometric wounds.
  • FIG. 1 is a front view of the present application.
  • FIG. 2 is a schematic diagram of an irregular geometric wound for the present application.
  • FIG. 3 is a schematic diagram of a ratchet structure of a pulling member of the present application.
  • FIG. 4 is a schematic diagram of a lacing structure used in the pulling member of the present application.
  • window 1 puller 2, holder 3, negative pressure sealing film 4 in the first region, negative pressure sealing film 5 in the second region, window negative pressure sealing chamber 6, peripheral negative pressure sealing chamber Chamber 7, mating reference support module 8, rigid reference plane 9, plastic body 10, baseband 11, lock 12, ratchet 13, tie 14, skin 15, window 16.
  • the wound closure shown in FIG. 1, FIG. 2, FIG. 3 and FIG. 4 includes a window 1, a retractor 2 and a holder 3, and the window 1 includes a window body wall and a window top wall.
  • the stapler 2 is provided on both sides of the window 1.
  • One end of the fastener 2 is connected to the holder 3 and the other end is connected to the window 1.
  • the side of the holder 3 facing the skin 15 is provided. Fixed paste layer.
  • an openable and closable window 16 may be provided on the top wall of the window. In this way, when the window 16 is needed, the window 16 can be opened and closed, and corresponding operations can be conveniently performed inside the window 1 through the window 16.
  • the function module located in the window 1 device can be incorporated or replaced through the window 16.
  • a window 1 corresponding to the wound skin margin healing area is provided.
  • An effective, reliable, and stable solid structural isolation is achieved between the non-functional healing areas on the periphery of the wound, so that various important functional modules provided in the structure of Form 1 can be more reliable and stable. It directly and continuously acts on the wound healing area, more effectively exerts the function of the functional module without bad interference from the outside, and can better promote good physiological healing of the wound.
  • the anchor 3 is located on the skin 15 on both sides of the midline of the wound, and the skin 15 on both sides of the midline of the wound is fixed by an adhesive layer. After the anchor 3 is connected to the stapler 2, the anchor 2 pulls the anchor 3 and the sides of the wound The skin 15 is pulled toward the window 1, driving the skin edges on both sides of the wound to close to the middle of the wound.
  • the top wall of the window is a flexible material and can settle down under negative pressure.
  • a window 16 is provided which can be opened and closed. When the window 16 is in the open state, the interior of the window 1 is open and visible. Functional modules located in the window 1 device can be incorporated or replaced to solve the wound area visualization.
  • an alignment reference support module 8 can be accurately placed on the wound surface, and the bottom surface of the alignment reference support module 8 facing the wound is a rigid reference plane 9. This can ensure that while the stapler 2 allows the wound skin edge to be aligned horizontally and axially toward the midline of the wound, the top wall of the window settles down under the synergistic effect of the negative pressure of the window 1, so that the wound skin edge is on the vertical axis of the wound.
  • the opening and closing structure of the window 16 may be implemented by a structure that facilitates opening and closing operations such as a sash that can be opened by turning, a window cover that can be slidably opened, a window cover that can be opened and disassembled, a snap-on cover, or a zipper.
  • the shape of the window 16 can be designed as a rectangle, a circle, or a special shape adapted to the wound according to the length of the wound and the shape of the wound or the need to place a treatment module.
  • the opening and closing method of the window 16 can be flexibly set as an integral opening or closing or a segmented independent opening and closing according to actual needs.
  • the area sealing film forms a peripheral negative pressure sealing chamber 7 with the outer wall of the window 1 and the peripheral skin 15.
  • the holder 3 is located in the peripheral negative pressure sealing chamber 7.
  • two independent negative pressure sealing chambers are formed by using the first area negative pressure sealing film 4 and the second area negative pressure sealing film 5. This makes it easy for doctors to achieve different independent operations in different areas and achieve different functional treatment goals.
  • the doctor can easily realize the functional module, which can be directly and sequentially fixed to the wound healing treatment according to the needs of the wound treatment only by opening and closing the window 16.
  • the doctor can independently operate the tether 14 or the spine 13 of the stapler 2 to adjust the tension of the peripheral skin 15.
  • the tension state of the wound applied by the locking device will not be affected due to the release of the overall negative pressure.
  • the wound treatment function module in window 1 will continuously and stably perform the treatment function. And treatment effect.
  • the double-negative pressure chamber wound closure device can ensure that the bleeding and exudation of the wound can be comprehensively and timely eliminated, and the mating reference platform is tightly pressed against the upper surface of the wound skin under the continuous action of negative pressure to avoid the suture device from falling off. , Suture failure, exudate accumulation secondary to wound infection.
  • the wall of the window body is a circular closed isolation fence.
  • the isolation fence can prevent wound exudate from flowing out and infiltrate the structures such as the holder 3 on the outside of the window 1, causing the suture device to fall off and suture failure, and the accumulation of exudate secondary to wound infection. Causes non-healing or delayed healing.
  • This application also specifically adds a plastic body structure to the isolation fence.
  • the geometric shape of the plastic body can be prefabricated according to the actual shape of the wound, and can be further flexibly prefabricated to adapt to the actual shape of the wound along the actual midline of the wound and extend a certain distance to both sides of the wound.
  • the shape of the closed ring and the shape of the plastic body determine the final geometry of the isolation fence, so that the wound functional healing areas of various shapes can be accurately prefabricated, and the precise customization and effective isolation of the wound functional healing areas can be achieved. It is ensured that the treatment module provided in the functional healing area can more effectively, reliably, stably, and directly continue to exert the function of the functional module without bad interference from the outside, and can better promote good physiological healing of the wound.
  • the retractor 2 of the present application is a ratchet structure or a tie 14 structure.
  • the ratchet structure includes a lock 12 and a ratchet bar 13.
  • the lock 12 is connected to the holder 3 and has a ratchet in the lock 12. Tooth, one end of the ratchet bar 13 is connected to the window 1 and the other end is inserted into the lock buckle 12.
  • the lock bar 12 has ratchet teeth to limit the one-way sliding of the ratchet bar 13 in one direction. 12 buckles.
  • the ratchet teeth of the lock buckle 12 can restrict the ratchet bar 13 from sliding unidirectionally outward.
  • the lock buckle 12 and the ratchet bar 13 can also pass through the second area of the negative pressure sealing film 5 and be located outside the sealing film. Pulling the spine 13 can drive the skin 15 on both sides of the wound to close in the middle.
  • the structure of the lace 14 includes a lace 14, which is folded back at the connection window 1 to form a folded portion. The folded portion of the lace 14 is connected and fixed to the surface of the holder 3 and the back of the lace 14 by setting an adhesive area. . Pulling the tether 14 in the opposite direction can bring the skin 15 to the center. The sticking area of the tether 14 can be fixed to the adhesive structure on the back of the tether 14 and the upper surface of the holder 3 at any position. Close distance makes operation more simple and convenient.
  • the strap 14 can further adopt a flat and thin structure. Due to the small space limitation, the flat strap 14 is more easily located in the peripheral negative pressure chamber.
  • the holders 3 are arranged on both sides of the window 1, the bottom surface of the holder 3 facing the skin 15 is provided with an adhesive layer, and is fixed on the surface of the outer skin 15 on both sides of the wound.
  • An edge of the anchor 3 facing the inside of the wound is provided with a base band 11 parallel to the outer wall of the corresponding window 1.
  • the fixture 3 can It is further provided as an independent segment, and the inner base band 11 of each independently segmented holder 3 is parallel to the corresponding outer wall segment of the window 1.
  • the base band 11 is a rigid linear skeleton.
  • the base band 11 can evenly pull the skin 15 on both sides of the wound in parallel to close to the midline. It can also ensure that each independently segmented wound skin edge is sutured when stitching irregularly shaped wounds. Both can be evenly aligned; the base band 11 collects the pulling force of each independent segment and transmits it to the corresponding window 1 segment through the pulling device 2. At the same time, the base band 11 also spreads the high pulling force that is converged between the window 1 and the holder 3, and spreads linearly and uniformly along the base band 11 to the surface of the holder 3 and the skin 15 to avoid the high pulling of the closer.
  • the stress is too concentrated or focused on the skin 15 of the wound, causing damage to the corresponding stress skin 15.
  • the suture tension during needle and suture stitching is focused on the puncture point of skin 15, which will inevitably cause cutting damage to skin 15 or even suture failure to suture failure; a purely reduced butterfly-shaped adhesive tape wound will necessarily appear at the wing root of the butterfly wing Severe skin 15 injuries such as tonic blistering cause treatment to be discontinued. Therefore, the arrangement of the base band 11 can better avoid suture failure or treatment suspension of the wound.
  • a functional treatment module is provided in the internal space of the window 1.
  • the functional module is a wound exudation absorption module that can absorb wound exudate in time, a wound hemostasis module that can help the wound to stop bleeding quickly, and a wound that can effectively prevent bacteria from growing.
  • Module wound information acquisition module that can use sensors to collect real-time wound information, and cell tissue regeneration module that can promote wound healing.
  • the sash setting of Form 1 is very convenient and can fully meet the doctor's needs according to the actual situation of the wound, or according to the actual clinical needs or the actual functional needs of different stages of wound healing, and can be used individually or in combination according to the needs of the treatment.
  • the treatment module used fully utilizes the functions of the treatment module, improves the efficiency of wound treatment, and realizes the reasonable customization of the use of different functional treatment modules during the wound healing process.
  • the treatment is based on symptoms and precise treatment, which promotes the wound better. Good physiological healing.
  • It also includes a negative pressure line that communicates the window negative pressure sealing chamber 6 and the peripheral negative pressure sealing chamber 7 with the outside.
  • a valve is arranged on the negative pressure pipeline and communicates with the outside of the negative pressure sealing film.
  • the present invention provides a stable solid isolation window 1 structure in the wound functional healing area to ensure that the built-in functional therapy module can continue to play more effectively, more reliably, more stable, and more directly. Functional therapeutic effect.
  • the setting of the in-coupling reference support module 8 further ensures that the wound cortex can be horizontally aligned and leveled in accordance with the original anatomy of the skin 15 horizontally and vertically.
  • the openable and closable window 16 on the form 1 is set to further meet the needs of doctors based on the actual situation of the wound, which should be used alone or in combination with the functional modules that should be used to achieve personalized customization of the wound healing plan, and symptomatic and precise treatment.
  • the plastic body prefabrication on the form 1 can better meet the precise customization and effective isolation of the wound healing area of various irregular geometric shapes, and further solve the problem of suture of clinical irregular geometric wounds. It can effectively avoid the undesirable consequences or secondary damage of the closure device such as the closure of the suture device, the failure of the wound suture, and the secondary wound infection. It can achieve good wound physiological regeneration and healing with higher efficiency and better effect.
  • the present application provides a more effective device for closing a wound, mainly by constructing a complete or independent and undisturbed treatment unit in a wound healing area located in the middle of the wound, so that the functional modules required for wound treatment can be reliable, Sustained, direct sustained action on wound healing area.
  • a solid window 1 structure is used to isolate the functional healing area in the middle of the wound from the pasting and fixing areas around the wound.
  • various important functions that can promote good physiological healing of the wound are independently set up. Module, so that each functional module inside Form 1 is isolated from the interference of the peripheral area, and reliably, stably, and directly acts on the wound healing area. Effectively avoid the accumulation of exudate, causing the suture device to fall off, secondary wound infection, wound suture failure, and wound malunion healing. Further achieve better wound physiological regeneration and healing.

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Abstract

一种涉及皮肤伤口缝合领域的伤口闭合器，包括窗体（1）、拉合器（2）和固定器（3）。窗体（1）包括窗体体壁和窗体顶壁，拉合器（2）设置在窗体（1）的两侧，拉合器（2）的一端与固定器（3）连接，另一端与窗体（1）连接，固定器（3）朝向皮肤的底面设置有固定粘贴层。这种伤口闭合器使伤口治疗所需功能模块能可靠的、持续的、直接的持续作用于伤口愈合区域，有效避免渗液集聚造成缝合装置脱落、继发伤口感染、伤口缝合失败、伤口错层畸形愈合，实现更好的伤口生理性再生愈合。

Description

伤口闭合器 技术领域
本发明涉及一种伤口闭合器，尤其是一种涉及皮肤伤口缝合领域的伤口闭合器。
背景技术
在人体医学解剖及组织修复领域，皮肤组织是人体内部与外部最基本及最重要的屏障封闭结构，皮肤组织包括皮肤表皮层、真皮层、皮下层。当这一屏障受到手术切割或外伤破坏后，必须通过手术缝合，使伤口的游离皮缘按皮肤原解剖结构尽快恢复原来的分层对合，并通过皮肤组织再生，恢复原皮肤的屏障结构及生理功能。为促进伤口游离皮缘分层对合，伤口皮缘在水平轴向、垂直轴向的精确对合及平整对伤口愈合尤为重要、是伤口生理性再生愈合的基础。在此基础上，在伤口愈合局部如能有效提供各种促进愈合的功能治疗模块，比如设置伤口渗液吸收模块、伤口止血模块、伤口抑菌抗菌模块、采集伤口信息的传感器模块、促进伤口愈合的细胞组织再生模块等，必将加快伤口生理愈合并提高伤口生理愈合的质量。
目前的现有技术，主要是采用各种类型的对合装置解决伤口两侧对合合拢问题。但是目前现有的各种对合装置，均只能简单的实现伤口在水平轴向的对合拉拢的功能，同时因各种复杂的拉合结构均直接横跨伤口上方，医护人员无法再次在位于伤口中间的伤口愈合区域，完整的或独立不受干扰的使用对伤口愈合有重要促进作用的各种功能治疗模块或单元：如伤口渗液吸收模块、伤口皮缘对合基准模块、伤口止血模块、伤口抑菌抗菌模块、采集伤口信息的传感器模块、促进伤口愈合的细胞组织再生模块。因此，目前现有的各种对合装置在实际临床应用中，尚不可避免出现如下弊端：一、缺乏独立的高效及时的清理伤口渗血、渗液模块，大量出现渗液集聚继发伤口感染、渗液集聚致缝合装置脱落、伤口缝合失败、伤口愈合延迟、伤口不愈合。二、缺乏持续有效的垂直对合强制机制或对合基准模块，无法保证伤口皮缘在垂直轴向对合平整，无法完成皮肤分层精确对合，出现大量错层畸形愈合(如台阶状错层愈合、疙瘩状愈合、不良疤痕体愈合)。三、伤口愈合区域缺乏有效的伤口止血模块、伤口抑菌抗菌模块、组织再生促进模块等持续作用，或实际不能保证上述模块是可靠的持续的直接作用于伤口愈合区域，其实际发挥的效率极低或实际缺失。难以实现良好的伤口生理性再生愈合。
发明内容
本发明所要解决的技术问题是提供一种更有效的伤口闭合器，在位于伤口中间的伤口愈合区域，建构一个完整的或独立不受干扰的治疗单元，使伤口治疗所需功能模块能可靠的、持续的、直接的持续作用于伤口愈合区域，有效避免渗液集聚造成缝合装置脱落、继发伤口感染、伤口缝合失败、伤口错层畸形愈合，实现更好的伤口生理性再生愈合。
本发明解决其技术问题所采用技术方案为：一种伤口闭合器，包括窗体、拉合器和固定器，所述窗体包括窗体体壁和窗体顶壁，所述拉合器设置在窗体的两侧，所述拉合器的一端与固定器连接，另一端与窗体连接，所述固定器朝向皮肤的底面设置有固定粘贴层。
进一步的是：窗体顶壁上设置有可开闭的窗口。
进一步的是，所述窗体内设置有对合基准支持模块，所述对合基准支持模块正对伤口的底面为刚性基准平面。
进一步的是，还包括第一区域负压密封膜和第二区域负压密封膜，所述第一区域负压密封膜与窗体体壁围成窗体负压密封腔室，所述第二区域密封膜与窗体的外壁及伤口外周皮肤围成外围负压密封腔室，所述固定器位于外围负压密封腔室。
进一步的是，所述窗体体壁为环形闭合的隔离围栏。
进一步的是，所述隔离围栏上附加有塑形体，塑形体的几何形状决定隔离围栏的最终几何形状，塑形体的几何形状，预制为沿实际伤口纵轴线方向两边延伸一定距离的闭合环形状。
进一步的是，所述窗体顶壁为一种柔性材料并在负压作用下可以向下沉降。所述窗体顶壁上，设置有可以开闭的窗口，窗口上设置有可以开闭的窗扇，窗扇闭合封闭窗体的顶壁，窗扇开启使窗体内部空间与外部空间相通。
进一步的是，所述拉合器包括锁扣和棘条，所述锁扣与固定器连接，锁扣内有棘齿，棘条一端与窗体连接固定，另一端插入锁扣中。进一步的是，所述拉合器可设置为系带，所述系带在连接窗体处反折形成反折部分，系带的反折部分设置粘贴区与固定器表面和系带背面连接固定。
进一步的是，所述固定器设置在窗体的两侧，固定器朝向皮肤的底面设置有粘贴层，粘贴固定在伤口两侧外周皮肤表面上。固定器朝向伤口内侧边缘设置有平行于对应窗体外壁的基带。
进一步的是，述功能模块为伤口渗液吸收模块和/或伤口止血模块和/或伤口抑菌抗 菌模块和/或伤口信息采集模块和/或细胞组织再生模块。
进一步的是，还包括负压管路，所述负压管路将内部负压密封腔室和外围负压密封腔室与外界连通。
本发明的有益效果是：在伤口中间的游离皮缘所处的伤口功能愈合区域，创造性的设置了一种对应于伤口皮缘愈合区域的窗体结构，通过设置窗体结构，在伤口功能愈合区域，与伤口外周非功能愈合区域之间，实现了一种有效、可靠、稳定的实体性结构性的隔离，因此，更有效的保证窗体结构内各种重要的治疗模块能更可靠的、稳定的、直接的持续作用于伤口愈合区域，充分发挥所述治疗模块的功能作用而不受外界的不良干扰，能更好的促进伤口良好生理愈合。同时在窗体结构上设置有预制塑形体，能进一步满足临床各种不规则几何形状伤口的功能愈合区的精准定制和有效隔离，进一步解决了临床不规则异形几何形状伤口的缝合难题。
附图说明
图1是本申请的主视图。
图2是本申请用于不规则几何形状伤口的示意图。
图3是本申请的拉合件采用棘齿结构的示意图。
图4是本申请的拉合件采用系带结构的示意图。
图中标记为：窗体1、拉合器2、固定器3、第一区域负压密封膜4、第二区域负压密封膜5、窗体负压密封腔室6、外围负压密封腔室7、对合基准支持模块8、刚性基准平面9、塑形体10、基带11、锁扣12、棘条13、系带14、皮肤15、窗口16。
具体实施方式
下面结合附图对本发明进一步说明。
如图1、图2、图3所和图4所示的伤口闭合器，包括窗体1、拉合器2和固定器3，所述窗体1包括窗体体壁和窗体顶壁，所述拉合器2设置在窗体1的两侧，所述拉合器2的一端与固定器3连接，另一端与窗体1连接，所述固定器3朝向皮肤15的一侧设置有固定粘贴层。
进一步的，可在窗体顶壁上设置有可开闭的窗口16。这样在需要时即可借助窗口16的开闭，可非常方便地通过窗口16在窗体1内部进行相应操作，例如通过窗口16可纳入或更换位于窗体1装置内的功能模块。
本申请在伤口中间的游离皮缘所处的伤口功能愈合区域，设置了一种对应于伤口皮缘愈合区域的窗体1，通过设置窗体1结构，在伤口皮缘的功能愈合区域，与伤口外周 非功能愈合区域之间，实现了一种有效、可靠、稳定的实体性结构性的隔离，因此可以使设置在窗体1结构内的各种重要的功能模块，能更可靠的、稳定的、直接的持续作用于伤口愈合区域，更有效发挥所述功能模块的功能作用而不受外界的不良干扰，能更好的促进伤口良好生理愈合。
固定器3位于伤口中线两侧的皮肤15，通过粘贴层固定伤口中线两侧的皮肤15，固定器3与拉合器2连接后，拉合器2通过拉合将固定器3及伤口两侧皮肤15向窗体1拉拢，带动伤口两侧皮缘向伤口中间闭合。
窗体顶壁为一种柔性材料并在负压作用下可以向下沉降。所述窗体顶壁上，设置有可以开闭的窗口16。当窗口16处于开启状态时窗体1内部开放可视，可纳入或更换位于窗体1装置内的功能模块，解决伤口区域可视化的开放式的处理皮肤15伤口的止血、渗液以及伤口皮缘的对平。
当窗体顶壁窗口16处于开启状态时，可以在伤口表面准确放置对合基准支持模块8，所述对合基准支持模块8正对伤口的底面为刚性基准平面9。这样可以保证在拉合器2让伤口皮缘向伤口中线水平轴向对合的同时，在窗体1负压的协同作用下，窗体顶壁向下沉降，使伤口皮缘在伤口垂直轴向，不错位无空隙的紧密贴向对合基准支持模块8的刚性基准平面9，强制使伤口皮缘在伤口垂直轴向平整分层对合，并达到刚性基准平面9的标准平整状态，即可同时保证伤口皮缘在水平轴向和垂直轴向都能按皮肤15原解剖结构分层对合和对平整。其中，窗口16的开闭结构可以采用，可以翻转开启的窗扇、可滑动开启的窗盖、可以拆卸开启的窗盖、可扣合的盖子或者采拉链等便于开闭操作的结构来实现。窗口16的形状，可根据伤口的长度及伤口形状或需要放置治疗模块的不同，设计为矩形、圆形、或适应伤口的异形形状。窗口16的开闭方式，可以依据实际需要灵活的设置为整体式开闭、或分段式独立开闭。
还包括第一区域负压密封膜4和第二区域负压密封膜5，所述第一区域负压密封膜4与窗体体壁围成窗体负压密封腔室6，所述第二区域密封膜与窗体1的外壁及外周皮肤15围成外围负压密封腔室7，所述固定器3位于外围负压密封腔室7。本申请特别利用第一区域负压密封膜4和第二区域负压密封膜5形成二个互相独立的双负压密封腔室。以此便于医生在不同的区域实现不同的独立操作并实现不同的功能治疗目的。在独立的窗体负压密封腔室6内，医生仅通过开闭窗口16，即可轻松的实现将功能模块，依据伤口治疗所需，依次有序的或组合式的直接固定在伤口愈合治疗区域，使伤口治疗所需模块能更稳定、更可靠、更持续有效的发挥所述功能模块的功能作用而不受外界的不 良干扰，以此能更好的促进伤口良好生理愈合。在外围负压腔室区域，医生可独立操作拉合器2的系带14或棘条13调节外周皮肤15的拉合。不会在独立实施伤口愈合区的相关治疗操作时，因整体负压解除而影响锁合装置施加伤口的拉合状态。不会在单独实施锁合力的调节时，影响窗体1负压腔室内对合基准支持模块8所维持的伤口对合状态、以及窗体1内伤口治疗功能模块持续稳定的发挥所述治疗功能及治疗效果。双负压腔室的伤口闭合器，能保证伤口渗血渗液能全面及时排除、保证对合基准平台在负压持续作用下紧贴并压迫在伤口皮缘的上表面，避免造成缝合装置脱落、缝合失败、渗液集聚继发伤口感染。
本申请中窗体体壁为环形闭合的隔离围栏。隔离围栏可以防止伤口渗液流出，浸润窗体1外部的固定器3等结构，造成缝合装置脱落缝合失败、渗液集聚继发伤口感染。造成不愈合或愈合延迟。
本申请还特别在隔离围栏上附加有塑形体结构，塑形体的几何形状可依据伤口的实际形状预制，可进一步灵活的预制为沿伤口实际中线，向伤口两边延伸一定距离的适应伤口实际形状的闭合环形状，塑形体的几何形状决定隔离围栏的最终几何形状，以此能精确的预制各种形状的伤口功能愈合区，实现伤口功能愈合区域的精准定制和有效隔离。保证设置在功能愈合区域内的治疗模块，能更有效、更可靠、更稳定、更直接的持续发挥所述功能模块的功能而不受外界的不良干扰，能更好的促进伤口良好生理愈合。同时通过实现预制塑形体的几何形状，能更好的适应临床大量存在的非直线型伤口，例如”折弯型、S型、L型、Z型”等各种不规则形状伤口的功能愈合区的精准定制和有效隔离。实际有益的结果是极大的延伸了产品处理临床伤口的适用范围，进一步解决了临床不规则形状伤口的缝合难题。
本申请的所述拉合器2为棘齿结构或者系带14结构，所述棘齿结构包括锁扣12和棘条13，所述锁扣12与固定器3连接，锁扣12内有棘齿，棘条13一端与窗体1连接，另一端插入锁扣12中锁扣12内有棘齿限制棘条13单向向外滑动，棘条13一端与窗体1连接，另一端插入锁扣12中。锁扣12的棘齿可以限制棘条13单向向外滑动。为便于操作也可将锁扣12和棘条13穿过第二区域负压密封膜5位于密封膜外面。拉动棘条13，可以带动伤口两侧的皮肤15向中间合拢。系带14结构包括系带14，系带14在其与连接窗体1处反折形成反折部分，系带14的反折部分通过设置粘贴区与固定器3表面和系带14背面连接固定。系带14反向拉动可以带动皮肤15向中间合拢，系带14的粘贴区可以在任意位置与系带14背面以及固定器3上表面设置的粘接结构互相粘接固定， 以此任意调节拉合距离，使操作更加简单方便。
其中系带14可以进一步采用扁薄的结构，因空间限制较小，扁平的系带14更容易设置位于外围负压腔室内。
其中固定器3设置在窗体1的两侧，固定器3朝向皮肤15的底面设置有粘贴层，粘贴固定在伤口两侧外周皮肤15表面上。固定器3朝向伤口内侧的边缘设置有平行于对应窗体1外壁的基带11。
为更好的缝合临床上大量存在的，常规缝合难于处理的非直线型不规则伤口，例如“折弯型、S型、L型、Z型”等各种不规则形状伤口，固定器3可以进一步设置为独立分段式的，并将每个独立分段的固定器3的内侧基带11，平行于所对应的窗体1外壁段。
其中，所述基带11是一种刚性的线性骨架，基带11可均匀的平行牵引伤口两侧皮肤15向中线闭合，在缝合不规则形状的伤口时也能保证每个独立分段的伤口皮缘均能对合均匀平齐；基带11汇集每个独立分段的拉合力，通过拉合器2传递给对应的窗体1段。基带11同时也将窗体1与固定器3之间汇聚的较高的拉合力，沿基带11以线性的均匀的分散到固定器3及其粘贴皮肤15表面，避免闭合器较高的拉合应力过于集中或聚焦在伤口局部皮肤15，而造成相应的应力性皮肤15损伤。例如针线缝合时的缝合拉力便是集中在皮肤15的穿刺点，必然造成皮肤15切割损伤甚至缝线脱出至缝合失败；单纯的减张蝶形胶布拉合伤口，必然在蝶翼的翼根部出现严重的张力性水泡等皮肤15损伤导致治疗中止。因此基带11的设置能更好的避免伤口的缝合失败或治疗中止。
窗体1内部空间内设置有功能治疗模块，所述功能模块为可以及时吸收伤口渗液的伤口渗液吸收模块、可以帮助伤口快速止血的伤口止血模块、可以有效避免细菌滋生的伤口抑菌抗菌模块、可以利用传感器采集实时伤口信息的伤口信息采集模块、可以促进伤口愈合的细胞组织再生模块。窗体1的窗扇设置，非常方便并能充分满足医生根据伤口的实际情况所需，或根据临床实际需要或伤口愈合不同阶段的实际功能需要，依据治疗所需按顺序单独使用或组合使用所需使用的治疗模块，充分发挥所述治疗模块的功能作用，提高伤口治疗效率，实现在伤口愈合过程中不同功能治疗模块使用方案的合理定制，因症施治和精准施治，更好的促进伤口良好生理愈合。
还包括负压管路，所述负压管路将窗体负压密封腔室6和外围负压密封腔室7与外界连通。负压管路上设置有阀门并连通负压密封膜的外侧。以保证伤口渗血渗液能及时排除；保证对合基准平台在负压作用下能紧贴并压迫在伤口皮缘的上表面，双负压腔室的伤口闭合器能更好保证紧贴伤口皮肤15不会脱离。
综上所述，本发明通过在伤口功能愈合区域，设置了一种稳定的实体的隔离窗体1结构，保证内置功能治疗模块能更有效、更可靠、更稳定、更直接的持续发挥所述功能治疗作用。对合基准支持模块8设置进一步保证伤口皮缘在水平轴向和垂直轴向都能按皮肤15原解剖结构分层水平对齐和垂直对合平整。窗体1上可开闭的窗口16设置，进一步满足医生根据伤口的实际情况所需单独或组合使用应该使用的功能模块，实现伤口愈合方案的个性化定制及因症施治和精准施治。窗体1上塑形体预制，能更好满足各种不规则几何形状伤口功能愈合区的精准定制和有效隔离，进一步解决了临床不规则几何形状伤口的缝合难题。能有效避免其他闭合器存在的渗液集聚造成缝合装置脱落、伤口缝合失败、继发伤口感染等不良后果或继发损害。能以更高效率及更好的效果实现良好的伤口生理性再生愈合。
本申请提供了一种更有效的闭合伤口的装置，主要的是在位于伤口中间的伤口愈合区域，建构一个完整的或独立不受干扰的治疗单元，使伤口治疗所需功能模块能可靠的、持续的、直接的持续作用于伤口愈合区域。具体的采用一种实体的窗体1结构，将伤口中间的功能愈合区域与伤口外周的粘贴固定区域隔离，实现在窗体1结构内，独立设置各种能促进伤口良好生理愈合的重要的功能模块，使窗体1内部各个功能模块受到隔离而不受外周区域的干扰影响的，并可靠的、稳定的、直接的持续作用于伤口愈合区域。有效避免渗液集聚造成缝合装置脱落、继发伤口感染、伤口缝合失败、伤口错层畸形愈合。进一步实现更好的伤口生理性再生愈合。

Claims (14)

  1. 伤口闭合器，其特征在于：包括窗体(1)、拉合器(2)和固定器(3)，所述窗体(1)包括窗体体壁和窗体顶壁，所述拉合器(2)设置在窗体(1)的两侧，所述拉合器(2)的一端与固定器(3)连接，另一端与窗体(1)连接，所述固定器(3)朝向皮肤(15)的底面设置有固定粘贴层。
  2. 如权利要求1所述的伤口闭合器，其特征在于：窗体顶壁上设置有可开闭的窗口(16)。
  3. 如权利要求1所述的伤口闭合器，其特征在于：所述窗体(1)内设置有对合基准支持模块(8)，所述对合基准支持模块(8)正对伤口的底面为刚性基准平面(9)。
  4. 如权利要求1所述的伤口闭合器，其特征在于：还包括第一区域负压密封膜(4)和第二区域负压密封膜(5)，所述第一区域负压密封膜(4)与窗体体壁围成窗体负压密封腔室(6)，所述第二区域密封膜与窗体(1)的外壁及伤口外周皮肤(15)围成外围负压密封腔室(7)，所述固定器(3)位于外围负压密封腔室(7)。
  5. 如权利要求1所述的伤口闭合器，其特征在于：所述窗体体壁为环形闭合的隔离围栏。
  6. 如权利要求5所述的伤口闭合器，其特征在于：所述窗体(1)的隔离围栏上附加有塑形体(10)。
  7. 如权利要求2所述的伤口闭合器，其特征在于：所述窗体(1)的窗口(16)上设置有可以开闭的窗扇。
  8. 如权利要求1所述的伤口闭合器，其特征在于：所述拉合器(2)为棘齿结构或者系带(14)结构，所述棘齿结构包括锁扣(12)和棘条(13)，所述锁扣(12)与固定器(3)连接，锁扣(12)内有棘齿，棘条(13)一端与窗体(1)连接，另一端插入锁扣(12)中，所述系带(14)结构包括系带(14)，系带(14)在其与连接窗体(1)处反折形成反折部分，系带(14)的反折部分通过设置粘贴区与固定器(3)表面和系带(14)背面连接固定。
  9. 如权利要求1所述的伤口闭合器，其特征在于：所述固定器(3)朝向伤口内侧的边缘设置有平行于对应窗体(1)外壁的基带(11)。
  10. 如权利要求1所述的伤口闭合器，其特征在于：所述窗体(1)内部空间内设置有功能模块，所述功能模块为伤口渗液吸收模块和/或伤口止血模块和/或伤口抑菌抗菌模块和/或伤口信息采集模块和/或细胞组织再生模块。
  11. 如权利要求4所述的伤口闭合器，其特征在于：还包括负压管路，所述负压管路将内部负压密封腔室和外围负压密封腔室(7)与外界连通。
  12. 如权利要求6所述的伤口闭合器，其特征在于：所述塑性体(10)呈折弯型。
  13. 如权利要求2所述的伤口闭合器，其特征在于：所述窗口(16)为分段独立式开闭设置。
  14. 如权利要求1所述的伤口闭合器，其特征在于：所述固定器(3)为独立式分段设置。
PCT/CN2019/082548 2018-09-20 2019-04-12 伤口闭合器 WO2020057113A1 (zh)

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