WO2023104045A1 - 用于外科手术的缝合器及穿刺器 - Google Patents

用于外科手术的缝合器及穿刺器 Download PDF

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Publication number
WO2023104045A1
WO2023104045A1 PCT/CN2022/136994 CN2022136994W WO2023104045A1 WO 2023104045 A1 WO2023104045 A1 WO 2023104045A1 CN 2022136994 W CN2022136994 W CN 2022136994W WO 2023104045 A1 WO2023104045 A1 WO 2023104045A1
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WO
WIPO (PCT)
Prior art keywords
assembly
suture
sleeve
core rod
airbag
Prior art date
Application number
PCT/CN2022/136994
Other languages
English (en)
French (fr)
Inventor
孙宝峰
王吉胜
Original Assignee
江苏风和医疗器材股份有限公司
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Publication of WO2023104045A1 publication Critical patent/WO2023104045A1/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
    • A61B17/04—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
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/313—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
    • 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
    • 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
    • A61B17/0491—Sewing machines for surgery
    • 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
    • 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
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles

Definitions

  • the present application relates to the technical field of surgical instruments, in particular to a stapler and trocar used in surgical operations.
  • the doctor generally makes a small incision in the patient's abdomen first, then aligns the puncture end of the puncture device with the small incision and moves the puncture device downward while reciprocating left and right, so that the puncture core assembly guides the puncture sleeve through the patient's abdominal cortex ; Then pull out the puncture core assembly, and use the trocar sleeve to inflate the abdominal cavity to complete and maintain the pneumoperitoneum.
  • the other trocars penetrate the abdominal wall in the same manner.
  • a channel for instruments to enter and exit the abdominal cavity can be established, and staplers or other surgical instruments can enter and exit the patient's abdominal cavity through the puncture sleeve for surgical operations.
  • staplers or other surgical instruments can enter and exit the patient's abdominal cavity through the puncture sleeve for surgical operations.
  • a puncture hole is connected with an air source to establish a pneumoperitoneum on the human body. to suture other puncture holes.
  • Such a stapler cannot naturally form a safe operating space, and can only be used in the state of pneumoperitoneum, and the suturing operation cannot be performed in the state of non-pneumoperitoneum, so it is impossible to suture the last puncture hole for gas injection to establish pneumoperitoneum, so that the patient will not be injured after surgery. Complications such as puncture hole hernia are prone to occur, and further treatment is required.
  • the present application aims to provide a stapler and a puncture device for surgical operations, which solves the problem that the stapler in the prior art cannot perform suturing operations in an airless state to sew the puncture holes, so that postoperative Complications such as puncture hole hernia are prone to occur.
  • a stapler for surgical operations comprising: a handle part, used to provide grip; core rod assembly, the proximal end of the core rod assembly is connected to the handle part, and the distal end of the core rod assembly is used to pass through the puncture hole, the puncture hole Located in the abdominal wall tissue of the human body; the suture assembly is used to suture the puncture hole, at least a part of the suture assembly is arranged on the core rod assembly, the suture assembly includes a suture thread and a suture needle, the end of the suture thread is connected to the suture needle, and the movement of the suture needle drives The suture thread sutures the puncture hole, and the movement of the suture needle includes the first movement located in the abdominal wall tissue of the human body and the second movement located in the inner space of the abdominal wall tissue of the human body;
  • the air bag has an uninflated first state and an inflated second state. In the first state, the diameter of the air bag assembly is smaller than the diameter of the air bag assembly in the second state. In the second state, the
  • the stapler further includes a gas transmission part, and the gas transmission part communicates with the air bag, so that the air bag can switch between the first state and the second state.
  • the gas transmission part includes a first airway and a second airway
  • the first airway is arranged on the core rod assembly and communicates with the airbag
  • the second airway is arranged on the handle part
  • the second airway communicates with the first airway
  • the external air source inflates the airbag through the first airway and the second airway.
  • At least two airbags there are at least two airbags, at least two airbags are arranged at intervals around the circumference of the core rod assembly, and in the second state, a protective space is formed between two adjacent airbags.
  • the distance between two adjacent airbags enclosing the protective space gradually decreases along the direction away from the core rod assembly, and the ends of the radial edges of the two adjacent airbags abut against or exist gap.
  • the airbag is fan-shaped.
  • the proximal end of the airbag forms a recessed portion that is recessed toward the distal end, and the inner space of the recessed portion is a protective space.
  • the airbag of the airbag assembly is made of non-deformable material, so that the airbag has a preset shape after being inflated.
  • non-deformable material is at least one of nylon and rubber.
  • the airbag assembly further includes a first sleeve, the airbag is disposed on the outer wall of the first sleeve, and the first sleeve is sleeved on the distal end of the core rod assembly.
  • the air bag assembly includes an air inlet, the air inlet is arranged on the first sleeve, and the air inlet communicates with the air bag;
  • the core rod assembly includes a first air passage, and the distal opening of the first air passage communicates with the air inlet.
  • the core rod assembly includes: a core rod, the outer wall of the core rod has a ventilation groove extending along the axial direction of the core rod; a second sleeve, the second sleeve is sleeved on the outside of the core rod, so that the ventilation groove A first airway is formed with the second sleeve.
  • the distal end of the air groove is located on the proximal side of the most distal end of the core rod, the second sleeve is sleeved on the core rod and the second sleeve avoids at least a part of the distal end of the air groove, so that at the far end of the air groove Forms the distal opening of the first airway.
  • the handle part includes a second airway, the second airway communicates with the first airway, one end of the second airway is an inflation port, and the inflation port can be connected with an air source to inflate the airbag.
  • the stapler also includes a wire storage assembly, which is connected to the distal end of the core rod assembly, and the wire storage assembly is used to accommodate at least part of the suture; the outer tube wall at the distal end of the first sleeve is provided with a An extended wire guide through which the end of the suture is threaded to connect with the suture needle.
  • the stapler also includes a wire storage assembly connected to the distal end of the core rod assembly, the wire storage assembly is used to accommodate at least part of the suture, the outer surface of the wire storage assembly is provided with a cutting edge, the cutting edge is used to Create a puncture hole.
  • the present application also provides a trocar, including: the above-mentioned stapler; and a cannula assembly, wherein the stapler extends into the cannula assembly.
  • the beneficial effect of the present application is that: by setting the air bag at the far end of the core rod assembly, the inflated air bag stretches the human organs and tissues while providing a protective space, so that the movement of the suture needle is limited in the protective space In the process of suturing the abdominal wall tissue of the human body, it can prevent the suture needle from accidentally injuring human organs and tissues, so that the suturing device can also perform suturing operations without pneumoperitoneum, thereby effectively avoiding puncture hole hernia caused by minimally invasive surgery puncture holes, effectively Reduce the pain of the patient and benefit the postoperative recovery of the patient.
  • Figure 1 is an exploded view of a stapler for surgical operations provided in the first embodiment of the present application
  • Fig. 2 is a schematic structural view of the surgical stapler provided in the first embodiment of the present application when the air bag is not opened;
  • Fig. 3 is a schematic structural view of the surgical stapler provided in the first embodiment of the present application when the air bag is opened;
  • Fig. 4 is a schematic structural view of the airbag assembly provided in the first specific embodiment of the present application.
  • Fig. 5 is a cross-sectional view of an angle of the airbag assembly provided in the first embodiment of the present application
  • Fig. 6 is a cross-sectional view from another angle of the airbag assembly provided in the first embodiment of the present application.
  • Fig. 7 is a schematic structural view of an airbag assembly provided in another specific embodiment of the present application.
  • Fig. 8 is a cross-sectional view at an angle of an airbag assembly provided in another specific embodiment of the present application.
  • Fig. 9 is a schematic structural view of the suturing needle entering the protective space of the stapler for surgical operations provided by the first embodiment of the present application;
  • Fig. 10 is a partial enlarged view of A place shown in Fig. 9;
  • Fig. 11 is a schematic view of the structure of the suturing device used for surgical operations provided by the first embodiment of the present application when the suturing needle penetrates into the abdominal wall tissue of the human body;
  • Fig. 12 is a schematic diagram of the trajectory of the suture in the abdominal wall tissue of the human body provided by the first embodiment of the present application;
  • Fig. 13 is a cross-sectional view of a stapler for surgery provided in the first embodiment of the present application.
  • Fig. 14 is a schematic structural view of the stapler for surgical operations provided by the second specific embodiment of the present application when the air bag is not opened;
  • Fig. 15 is a schematic structural view of the surgical stapler provided in the second embodiment of the present application when the air bag is opened;
  • Fig. 16 is a cross-sectional view at an angle of the airbag assembly provided in the second specific embodiment of the present application.
  • Fig. 17 is a schematic structural view of the trocar provided in the third embodiment of the present application when the airbag is not opened;
  • Fig. 18 is a schematic structural view of the trocar provided by the third embodiment of the present application when the airbag is opened.
  • proximal and distal are relative to the clinician manipulating the stapler.
  • proximal refers to the portion near the clinician and the term “distal” refers to the portion remote from the clinician. That is, the end close to the handle part 10 is the proximal end, and the end close to the wire storage assembly 60 is the distal end.
  • the stapler can be used in many orientations and positions, so these terms expressing relative positional relationships are not limiting and absolute.
  • this embodiment provides a stapler for surgery, including a handle part 10 , a mandrel assembly 20 , a suturing assembly 30 and a balloon assembly 40 .
  • the handle portion 10 is used to provide a grip.
  • the proximal end of the core rod assembly 20 is connected to the handle part 10 , and the distal end of the core rod assembly 20 is used to pass through the puncture hole 110 .
  • the suture assembly 30 is used to suture the puncture hole 110 , at least a part of the suture assembly 30 is disposed on the core rod assembly 20 .
  • the suturing assembly 30 includes a suture thread 31 and a suture needle 32. The end of the suture thread 31 is connected to the suture needle 32.
  • the movement of the suture needle 32 drives the suture thread 31 to sew the puncture hole 110.
  • the movement of the suture needle includes the first movement of the abdominal wall tissue of the human body. and a second movement located in the medial space of the human abdominal wall tissue.
  • the balloon assembly 40 includes a balloon 41 disposed at the distal end of the mandrel assembly 20 .
  • the airbag 41 has a first state of being uninflated and a second state of being inflated. In the first state, the core rod assembly 20 and the airbag assembly 40 can pass through the puncture hole 110 or move out from the puncture hole 110 . In the second state, the airbag 41 provides a protective space 100 , and the second movement of the suture needle 32 is restricted within the protective space 100 .
  • the diameter of the airbag assembly 40 in the first state is smaller than the diameter of the airbag assembly 40 in the second state.
  • the diameter of the airbag assembly 40 is actually the diameter of the airbag 41 .
  • the diameter of the airbag 41 refers to the maximum distance between one end and the other end of the airbag 41 in the radial direction.
  • the human organ tissue located in the inner space of the human abdominal wall tissue 90 and around the airbag 41 is expanded to form a protective space 100 in the area where the airbag 41 is located.
  • the suture needle 32 gradually protrudes from the core rod assembly 20 and drives the suture thread 31 along an arc-shaped trajectory in the protected space 100 to penetrate the human abdominal wall tissue 90 from the inner side wall of the human abdominal wall tissue 90, and then pass through the puncture hole.
  • the hole wall of 110 penetrates into the puncture hole 110, the second movement of the suture needle 32 in the inner space of the abdominal wall tissue of the human body is located in the protected space, and the movement of the suture needle 32 after penetrating the abdominal wall tissue 90 of the human body is the first movement, that is, The suture needle performs the first movement after performing the second movement.
  • the puncture hole 110 is a hole-like wound formed by puncturing the abdominal wall tissue 90 of the human body with other sharp and pointed surgical instruments.
  • the abdominal wall tissue 90 of the human body has a certain thickness, including the inner wall and the opposite outer wall.
  • the wall is the skin, and human organs and tissues are located in the inner space of the human abdominal wall tissue 90 .
  • the inner space refers to the space within the inner wall of the human abdominal wall tissue 90 , not the thickness of the human abdominal wall tissue 90 .
  • the inflated air bag stretches the human organs and tissues, and at the same time provides a protective space, so that the second movement of the suture needle is limited in the protective space, avoiding the suture needle accidentally hurting the human body during the suture process Organ tissue, so that the stapler can also perform suturing operation without pneumoperitoneum, thereby effectively avoiding the hernia of the puncture hole caused by the puncture hole of minimally invasive surgery, effectively reducing the pain of the patient, and benefiting the postoperative recovery of the patient.
  • the stapler also includes a gas transmission part, the gas transmission part communicates with the air bag 41, so that the air bag 41 switches between the first state and the second state, the gas transmission part includes the first air channel 21 and the following Second airway11.
  • the first air channel 21 and the second air channel 11 will be described in detail below.
  • FIG. 3 there are at least two airbags 41, and at least two airbags 41 are arranged at intervals around the circumference of the mandrel assembly 20. Protection space 100.
  • there are two airbags 41 and the two airbags 41 are arranged at intervals around the circumference of the mandrel assembly 20.
  • two opposite protection spaces 100 are formed, as shown in Fig. 4 and Fig. 5 Show.
  • the sidewall of the protection space 100 does not strictly extend along the radial direction of the core rod assembly 20 , therefore, the protection space formed after the airbag 41 is inflated is not a standard fan shape.
  • the protection space 100 may be set in a standard fan shape.
  • the two airbags 41 are roughly fan-shaped, including the shape shown in FIG. 5 and standard fan-shaped. At this time, the distance between the two airbags enclosing the protection space remains constant or gradually increases along the direction away from the core rod assembly 20 (ie, the radial direction).
  • the distance between the outer surface of the airbag 41 and the core rod assembly 20 is greater than the maximum distance between the suture needle 32 and the core rod assembly 20 during movement
  • the distance between the distal surface of the balloon 41 and the inner sidewall of the human abdominal wall tissue 90 is greater than the distance between the suturing needle 32 and the inner sidewall of the human abdominal wall tissue 90 when protruding from the mandrel assembly 20 .
  • the protective space 100 can fully accommodate the movement trajectory of the suture needle 32 in the inner space of the abdominal wall tissue 90 of the human body, so that the suture needle 32 moves in the protective space 100 before penetrating the abdominal wall tissue 90 of the human body, thereby avoiding Accidentally injuring other tissues or organs of the human body, thereby effectively protecting the tissues or organs of the human body, such as human organ tissues.
  • the distance between two adjacent airbags 41 enclosing the protective space 100 decreases gradually along the direction (radial direction) away from the core rod assembly 20, and the distance between two adjacent airbags 41
  • the ends of the radial edges of the airbags 41 are abutted to effectively prevent organs and tissues from entering the protective space.
  • the ends of the radial edges of two adjacent airbags 41 may be close to each other but there is a gap, as shown in Figure 7 As shown in FIG. 8 , the small gap can also effectively prevent organs and tissues from entering the protective space.
  • the airbag 41 of the airbag assembly 40 is made of non-deformable material, so that the airbag 41 has a preset shape after being inflated, so that the formed protection space 100 has stability. If the airbag 41 does not have a preset shape, it will have different sizes under different inflated states, which may occupy the protective space 100 or be punctured by the suture needle 32 .
  • the non-deformable material may be at least one of nylon and rubber.
  • the airbag assembly 40 further includes a first sleeve 42 .
  • the airbag 41 is arranged on the outer wall of the first sleeve 42, and the first sleeve 42 is sleeved on the distal end of the core rod assembly 20, so that the airbag assembly 40 is sleeved on the distal end of the core rod assembly 20.
  • Such installation The method is simple and firm.
  • the airbag 41 is integrally arranged on the outer wall of the first sleeve 42. Specifically, in the first state, that is, in the uninflated state, the airbag 41 is sucked and deflated as a whole and then attached to the first sleeve 42. on the outside.
  • the diameter of the airbag 41 is slightly larger than the diameter of the first sleeve 42 .
  • the airbag 41 expands outward from the outer wall of the first sleeve 42 to form a preset shape.
  • the diameter of the airbag 41 in the second state is larger than that in the first state.
  • the edges of the airbag 41 are all connected to the outer wall of the first sleeve 42 so that the airbag 41 is tightly connected with the first sleeve 42 .
  • the airbag 41 and the first sleeve 42 are integrally formed.
  • the first sleeve 42 is integrally sheathed on the core rod assembly 20 .
  • the first sleeve 42 includes a middle sleeve 422 and a side sleeve 423 connected in the axial direction.
  • the airbag 41 is disposed on the middle sleeve 422
  • the air inlet 421 is disposed on the middle sleeve 422 .
  • the side casing 423 includes an upper casing and a lower casing respectively located at the proximal end and the distal end of the middle casing 422 .
  • the middle sleeve 422 has an upper edge and a lower edge in the axial direction, and the upper edge and the lower edge respectively connect with the edge of the surface of the airbag 41 to divide the upper sleeve, the middle sleeve 422 and the lower sleeve.
  • the side sleeve 423 By setting the side sleeve 423, the stability of the installation of the airbag assembly is increased. Further, when the air inlet 421 is arranged on the middle sleeve 422 of the first sleeve 42, the upper sleeve and the lower sleeve (that is, the side sleeve 423) ensure the airtightness of the air bag assembly 40 installed on the core rod assembly 20 resistance to avoid air leakage.
  • the first sleeve 42 does not have an upper sleeve or a lower sleeve, or does not have a side sleeve 423 , and relatively, the installation stability and airtightness are weakened.
  • the airbag assembly 40 includes the upper air inlet 421 .
  • the air inlet 421 is disposed on the first sleeve 42 , specifically, the air inlet 421 passes through the middle sleeve 422 of the first sleeve 42 and communicates with the airbag 41 .
  • the core rod assembly 20 includes a first air channel 21 , the distal opening of the first air channel 21 is located on the surface of the core rod 22 (note: is this actually the case) and communicates with the air inlet 421 .
  • the air inlet 421 communicates with the distal opening of the first air channel 21 correspondingly and adapts to the shape of the distal opening of the first air channel 21 .
  • the core rod assembly 20 includes a core rod 22 and a second sleeve 23 .
  • the outer wall of the core rod 22 has a ventilation groove 221 extending along the axial direction of the core rod 22 .
  • the second sleeve 23 is sleeved on the outside of the core rod 22 , so that the above-mentioned first air channel 21 is formed between the air groove 221 and the second sleeve 23 .
  • the first sleeve 42 is sleeved on the distal end of the core rod 22 and is sealingly connected with the second sleeve 23 and the distal end of the core rod 22 .
  • the gas can only be introduced to the air inlet 421 of the first sleeve 42 through the ventilation groove 221 and the distal opening of the first air passage 21, so as to ensure that the airbag 41 is not leaked when
  • the second sleeve 23 is made of film material, and therefore has a relatively thin thickness. While ensuring the sealing effect of the second sleeve 23 on the core rod 22, the weight of the second sleeve 23 can be reduced so that the whole stapler is light, flexible and easy to use.
  • the distal end of the ventilation groove 221 does not extend to the most distal end of the core rod 22 , that is, the distal end of the ventilation groove 221 is located near the most distal end of the core rod 22 .
  • the second sleeve 23 avoids at least a part of the distal end of the ventilation groove 221 to form a distal opening of the first air channel 21 at the distal end of the ventilation groove 221 .
  • the length of the second sleeve 23 is shorter than the length of the ventilation groove 221.
  • FIG. 2 is a schematic structural view of the stapler provided in the specific embodiment of the present application when the air bag 41 is not opened.
  • the airbag assembly 40 is made of film material, so it has a relatively thin thickness, so that the distal end of the stapler can pass through the puncture hole 110 and enter below the abdominal wall tissue 90 of the human body.
  • the airbag 41 is in the first state, the airbag 41 is attached to the first sleeve 42, and the airbag 41 is attached to the outer surface of the core rod 22 through the first sleeve 42.
  • the airbag 41 and the first sleeve 42 are opposite Because the core rod 22 has only a relatively thin thickness, it can reduce frictional resistance and facilitate the entry of the stapler into the human body.
  • FIG. 3 is a schematic structural view of the stapler provided in the specific embodiment of the present application when the air bag 41 is opened.
  • the airbag 41 When the airbag 41 is in the second state, the airbag 41 expands outwards and opens, and there is a certain distance between the outer surface of the airbag 41 and the core rod assembly 20 , thereby forming a protective space 100 .
  • FIG. 9 is a schematic structural view of the suturing device provided by the specific embodiment of the present application when the suturing needle 32 enters the protective space 100 .
  • the core rod 22 has a hollow cavity (not shown in the figure), and the outer rod wall at the distal end of the core rod 22 is also provided with a first needle outlet 223 communicating with the hollow cavity.
  • the first sleeve 42 has a second needle outlet 425 corresponding to the first needle outlet 223.
  • the outer rod wall at the distal end of the core rod 22 is also provided with a first needle opening 224 spaced apart from the first needle outlet 223, and the second sleeve 23 has a second needle opening 231 corresponding to the first needle opening 224.
  • the second sleeve 23 is nested behind the core rod 22 , and the first needle opening 224 coincides with the second needle opening 231 .
  • the moving direction of the suturing needle 32 is from the distal end to the proximal end, so the first needle retaining port 224 is arranged near the proximal end of the core rod 22 relative to the first needle exit port 223 .
  • first needle outlets 223 in order to cooperate with two suture needles 32 , there are two first needle outlets 223 and are arranged oppositely, and correspondingly, there are also two second needle outlets 425 and are arranged oppositely.
  • first needle retaining openings 224 and they are arranged oppositely, and correspondingly, there are also two second needle retaining openings 231 and they are oppositely arranged.
  • the stapler also includes a wire storage assembly 60 .
  • the wire storage assembly 60 is connected to the distal end of the mandrel assembly 20 , and the wire storage assembly 60 is used for accommodating at least a part of the suture 31 .
  • the wire storage assembly 60 is tapered with its tip facing the distal end, and the outer surface of the wire storage assembly 60 is provided with a cutting edge, which is used to form the puncture hole 110 .
  • the structure of the wire storage assembly 60 will be described in detail below.
  • the outer tube wall of side sleeve pipe 423 is provided with the wire groove 424 that extends along the axial direction of first sleeve pipe 42, and the end of suture thread 31 passes through wire groove 424 and suture needle 32 connections. Specifically, the end of the suture thread 31 passes through the guide wire groove 424 and extends into the second needle outlet 425 to be connected with the suture needle 32 .
  • the first sleeve 42 has a region where the wire groove 424 is recessed into the first sleeve 42, and the outer rod wall of the core rod 22 also has an accommodating groove 225 extending in the axial direction of the core rod 22, the first The inward concave portion of the sleeve 42 is inserted into the receiving groove 225 .
  • the first sleeve 42 fits just right with the core rod 22 at the wire groove 424 .
  • one end of the accommodating groove 225 communicates with the first needle outlet 223 , and the other end is located at the farthest end of the core rod 22 .
  • suture thread 31 is one thread, and the middle part of the suture thread 31 is stored in the thread storage assembly. 60 , both ends of the suture thread 31 protrude from the thread storage assembly 60 and respectively pass through the two thread grooves 424 , so as to be connected to the suture needle 32 at the first needle outlet 223 .
  • the suture 31 can be accommodated in the wire groove 424, thereby not increasing the diameter of the mandrel assembly 20.
  • the frictional resistance can be reduced so that the stapler can directly penetrate into the human body.
  • the inner diameter of the hollow cavity of the cannula assembly 80 is not increased.
  • FIG. 10 is a partial enlarged view of A shown in FIG. 9 .
  • the suture needle 32 comprises a suture needle head 321 and a suture arm 322, and the suture needle head 321 is detachably connected with the suture arm 322.
  • the suturing needle 32 further includes a connecting portion 323 which is detachably connected to the suturing needle head 321 and which is fixedly connected to the suturing arm 322 .
  • the connecting portion 323 is a cylinder extending along the length direction of the suturing arm 322 , and its outer diameter is smaller than that of the suturing arm 322 .
  • the suture 31 is connected with the suture needle 321 , and the suture needle 32 passes through the hole wall of the puncture hole 110 and enters the core rod assembly 20 through the second needle retention port 231 and the first needle retention port 224 .
  • the core rod assembly 20 is provided with a needle receiver, which is located in the first needle opening 224 , and the suture needle 321 is fixedly connected to the needle receiver after entering the first needle opening 224 .
  • the needle receiver includes a receiving part, a holding part and a receiving piece.
  • the clamping part is located on both sides of the receiving part, the receiving piece is located in the center of the receiving part, and the receiving part and the clamping part are integrally formed.
  • the holding part has a bent shape
  • the receiving piece is an elastic mesh piece or an elastic hollow piece with a hollow structure, which is used to hold the suture needle 321 .
  • the receiving piece is located in the first needle retaining port 224, and after the suture needle 321 passes through the hole wall of the puncture hole 110, it penetrates into the second needle retaining port 231 and the first needle retaining port 224 and is held by the receiving sheet.
  • the suture needle head 321 of the other suture needle 32 is held synchronously by the receiving piece of the needle receiver in the same manner, so as to realize receiving the suture needle head.
  • the suturing needle 32 is retracted, and the suturing needle 321 is separated from the suture arm 322 so that the suture needle 321 stays in the core rod assembly 20, and the suturing arm 322 passes through the second needle outlet 425, the first needle outlet 223, and the protected space 100. Back into the mandrel assembly 20.
  • FIG. 11 is a schematic diagram of the structure of the stapler provided in the specific embodiment of the present application when the suturing needle 32 penetrates the abdominal wall tissue 90 of the human body.
  • the suturing needle 32 protrudes from the first needle outlet 223 and enters the protective space 100 formed by the air bag 41 , and then continues to move proximally along the arc track so as to penetrate into the abdominal wall tissue 90 of the human body.
  • FIG. 12 is a schematic diagram of the movement trajectory of the suture 31 in the abdominal wall tissue 90 of the human body according to the specific embodiment of the present application.
  • the suture thread 31 moves under the drive of the suture needle 321
  • FIG. 10 is also a schematic diagram of the movement track of the suture needle 321 .
  • the two suturing needles 321 protrude from a first needle outlet 223 and enter a protective space 100 in one-to-one correspondence, and the two suturing needles 321 pass through points A and B respectively. into the abdominal wall tissue 90 of the human body.
  • point A and point B are respectively located on opposite sides of the puncture hole 110 .
  • the suture needle 321 continues to drive the suture thread 31 to move in the abdominal wall tissue 90 of the human body, and then the two suture needles 321 pass through points C and D respectively and enter the two first needle openings 224 Inside.
  • point C and point D are respectively located on opposite sides of the inner wall of the puncture hole 110 .
  • the stapler also includes a driving assembly 70 .
  • the drive assembly 70 includes a suture button 71 and a drive rod 72 drivably connected to the suture button 71, the suture button 71 is disposed at the proximal end of the handle portion 10, the core rod assembly 20 has a hollow cavity 222, and the drive rod 72 is disposed in the hollow cavity 222 It is internally connected with the suture needle 32 in a drivable manner, so as to drive the suture needle 32 to suture the puncture hole 110 .
  • the suture assembly 30 also includes a transmission member 33, the suture needle 32 is connected with the transmission member 33, and the transmission member 33 is drivably connected with the driving rod 72, thereby driving the suture needle 32 to move.
  • the transmission member 33 includes a rotating shaft and a gear sheathed on the rotating shaft.
  • the drive rod 72 is provided with a rack segment meshed with the gear.
  • the rack segment drives the gear to rotate, and then drives the rotation shaft to rotate.
  • the end of the suturing arm 322 away from the suture needle 321 is connected to the rotating shaft, and the suturing arm 322 is arc-shaped, so that it rotates along an arc track driven by the rotating shaft.
  • the suturing button 71 When the puncture hole 110 needs to be sutured, the suturing button 71 is pressed, and the driving rod 72 moves to the distal end in the axial direction, driving the suturing needle 32 to rotate to the proximal end, thereby protruding from the first needle outlet 223 and entering the protective space 100 , and then penetrate into the abdominal wall tissue 90 of the human body.
  • the driving assembly and the suturing assembly reference may be made to the descriptions of known embodiments with publication numbers CN111870321A and CN111870292A, and details are not repeated here.
  • the wire storage assembly 60 includes a storage structure and a hollow outer casing.
  • the storage structure is fixedly connected to the farthest end of the core rod 22, the storage structure is accommodated in the outer casing and the annular space between the storage structure and the outer casing forms a storage space, and the suture 31 is stored in the storage space.
  • the storage structure includes a winding part, and the wire storage assembly has an initial state and a released state. When in the initial state, the suture 31 is wound around the winding part, so that the suture 31 is entirely stored in the storage space.
  • the outer casing is drivably connected to the driving rod 72.
  • the driving rod 72 moves axially to the distal end, it drives the outer casing to also move to the distal end, so that the outer casing is separated from the storage structure.
  • the wire storage assembly changes from the initial state to In the released state, the storage space is exposed, and because the suture 31 itself has a certain elasticity, the suture 31 pops out from the storage space and is exposed.
  • the handle portion 10 includes a second air passage 11 disposed inside the handle portion 10 , the second air passage 11 communicates with the first air passage 21 , and one end of the second air passage 11 is an inflation port 12 .
  • the inflation port 12 can be connected with an air source to inflate the airbag 41 .
  • the handle part 10 also includes an inflation valve, and the inflation valve is arranged at the inflation port 12 . Specifically, the check valve of the inflation valve is kept closed under normal pressure, and the inflation valve will be opened only when external air with a certain pressure enters the inflation valve, thereby avoiding air leakage.
  • this embodiment provides a stapler.
  • the difference between the stapler in this embodiment and the stapler in Embodiment 1 is that the structure of the airbag assembly 40 is different.
  • FIG. 14 is a schematic structural view of the stapler provided in Embodiment 2 of the present application when the air bag 41 is not opened.
  • the airbag 41 in Embodiment 2 of the present application also has a first uninflated state and an inflated second state.
  • the airbag 41 is attached to the first sleeve 42, and the airbag 41 is attached to the outer surface of the core rod 22 through the first sleeve 42.
  • the airbag 41 and the first sleeve 42 are opposite Because the core rod 22 has only a relatively thin thickness, it can reduce frictional resistance and facilitate the entry of the stapler into the human body.
  • FIG. 15 is a schematic structural view of the stapler provided in the specific embodiment of the present application when the air bag 41 is opened.
  • the airbag 41 When the airbag 41 is in the second state, the airbag 41 expands outwards and opens. After the airbag 41 is inflated, it is bowl-shaped with the mouth of the bowl facing the proximal end of the core rod assembly 20 .
  • the distance between the inner wall of the bowl-shaped air bag 41 and the core rod assembly 20 is greater than the maximum distance between the suture needle 32 and the core rod assembly 20 during movement.
  • the first sleeve 42 communicates with the bottom of the airbag 41.
  • the proximal end of the airbag 41 forms a recess that is inwardly (that is, toward the distal direction) , the inner space of the recessed part is the protection space 100, as shown in FIG. 14 .
  • the specific embodiment of the present application also provides a trocar, including the above-mentioned stapler and a cannula assembly 80 , and the stapler extends into the cannula assembly 80 .
  • Above-mentioned stapler does not possess puncture function, can be punctured by other sharp and pointed surgical instruments this moment.
  • the wire storage assembly 60 is tapered with the tip facing the distal end, that is, forms a puncture tip.
  • the outer shell of the wire storage assembly 60 is tapered toward the distal end, which forms a puncture tip, and other structures of the wire storage assembly 60 are the same as the aforementioned wire storage assembly.
  • the outer surface of the wire storage assembly 60 is provided with a cutting edge for forming a puncture hole 110 .
  • the outer surface of the outer casing of the wire storage assembly 60 is provided with a cutting edge.
  • FIG. 17 is a schematic structural view of the piercer provided in the specific embodiment of the present application when the air bag 41 is not opened.
  • FIG. 18 is a schematic structural view of the piercer provided in the specific embodiment of the present application when the air bag 41 is opened.
  • the piercer according to the specific embodiment of the present application has both the piercing function and the suturing function. During the operation, the doctor first makes a small incision in the abdomen of the patient, and utilizes the puncture point of the stapler provided by the application to puncture the human tissue to form the puncture hole 110, and the air bag 41 is not opened at this time.
  • Insert the lower end of the sleeve assembly 80 into the human body separate the stapler from the sleeve assembly 80 by pressing the insert block assembly (not shown), and pull out the stapler from the sleeve assembly 80. At this time, the airbag 41 also not opened. Then the surgical instrument is inserted into the sleeve assembly 80 to perform the operation. After the operation is completed, the surgical instrument is taken out, the stapler is reinserted in the sleeve assembly 80, and the stapler and the sleeve assembly are re-locked by the insert block assembly. Then, start the sewing operation.
  • the far-end of the stapler is passed through the puncture hole 110 to go deep into the inner side of the abdominal wall tissue 90 of the human body, so that the air bag 41 is completely positioned at the inner side of the abdominal wall tissue 90 of the human body, and the air bag 41 is injected into the air bag 41 to open it, and then Move the stapler to the proximal end, the opened air bag 41 can resist the inner wall of the human abdominal wall tissue 90 around the puncture hole 110, thereby playing a position-limiting role, the stapler can no longer move to the proximal end, and is in the best suturing position .
  • the suture needle 32 protrudes from the first needle outlet 223 and enters the protection space 100 , and then penetrates into the human abdominal wall tissue 90 on the opposite side of the puncture hole 110 .
  • the storage thread assembly 60 releases the storage of the suture thread 31 so that the suture needle 32 can drive the suture thread 31 to pass through the abdominal wall tissue 90 of the human body, and the release method will not be repeated here.
  • the suturing needle 321 enters the first needle opening 224, and the suturing arm 322 returns to the first needle outlet 223, the airbag 41 is pumped, so that the airbag 41 returns to the bonding state, that is, the first state, so that the stapler is taken out.
  • the stapler drives the suture needle 321 left in the first needle retaining port 224, and then takes out the two ends of the suture 31 connected to the suture needle 321 from the puncture hole, as shown in FIG. 12 .
  • the stapler is moved to the proximal end, the part of the suture thread 31 below the puncture hole 110 is pulled and gradually shortened, so that the puncture hole 110 is tightened, and finally the portion of the suture thread 31 is drawn above the tightened puncture hole 110.
  • the two ends are interspersed and knotted, and the excess suture thread 31 is cut off, and the puncture hole 110 is sutured.
  • the puncture device of the present application by setting the air bag 41 at the distal end of the mandrel assembly 20, the inflated air bag 41 stretches the human organs and tissues, no need to establish an insufflation device, and the use of a stapler is no longer necessary.
  • a protective space 100 is provided, so that the movement of the suture needle 32 is limited in the protective space 100, so as to prevent the suture needle 32 from accidentally injuring human organs and tissues in the process of suturing the abdominal wall tissue of the human body, thereby
  • This enables the stapler to perform suturing operations even in the non-pneumoperitoneum state, thereby effectively avoiding the hernia of the puncture hole caused by the puncture hole of the minimally invasive operation, effectively reducing the pain of the patient, and facilitating the postoperative recovery of the patient.

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Abstract

一种用于外科手术的缝合器及穿刺器。缝合器包括：手柄部（10）；芯杆组件（20），近端连接手柄部（10），远端用于穿过穿刺孔（110）；缝合组件（30），至少一部分设置于芯杆组件（20），缝合组件（30）包括缝合线（31）和缝合针（32），缝合针（32）运动带动缝合线（31）缝合穿刺孔（110），缝合针（32）的运动包括位于人体腹壁组织（90）的第一运动和位于人体腹壁组织（90）的内侧空间的第二运动；气囊组件（40），包括气囊（41），气囊（41）设置在芯杆组件（20）的远端，气囊（41）具有未充气的第一状态和充气的第二状态，在第一状态时气囊组件（40）的直径小于在第二状态时的直径，在第二状态时，气囊（41）提供保护空间（100），缝合针（32）的第二运动限制于保护空间（100）内，解决了现有技术中缝合器无法在无气腹状态进行缝合操作以缝合穿刺孔，使得术后容易产生穿刺孔疝等并发症的问题。

Description

用于外科手术的缝合器及穿刺器
相关申请
本申请要求于2021年12月9日提交至中国专利局、申请号为202111503933.9，申请名称为“用于外科手术的缝合器及穿刺器”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及外科器械技术领域，特别是涉及一种用于外科手术的缝合器及穿刺器。
背景技术
目前，外科手术中腔镜手术已经得到广泛接受。在微创腹腔镜医疗手术中，如在人体体内发现病灶需要手术或切除，则手术过程中需对人体腹腔内进行气腹。建立气腹是腹腔镜手术的重要操作过程，在气腹充足的情况下，不仅撑开了腹腔壁与脏器之间的距离，也撑开了脏器与脏器之间的距离，为术者提供相对宽阔的视野和易于操作的手术环境。医生一般先在患者腹部划开一个小切口，再将穿刺器的穿刺端对准划开的小切口左右往复转动的同时向下移动穿刺器，使穿刺芯组件引导穿刺套管穿过患者腹部皮层；接着拔出穿刺芯组件，利用穿刺器套管对腹腔充气以完成和维持气腹。其它的穿刺器以同样的方式穿刺入腹壁。无论是完成和维持气腹的穿刺器套管，还是其它的穿刺器的套管，均可以建立器械进出腹腔的通道，吻合器或其他手术器械可通过穿刺套管进出患者腹腔进行手术操作。手术结束后，当对患者的穿刺孔缝合时，尤其是肥胖患者的穿刺孔，只能使用专门缝合穿刺孔的缝合器，通常为一个穿刺孔连接气源以对人体建立气腹，利用缝合器来缝合其它的穿刺孔。这样的缝合器无法自然形成安全操作空间，只能在有气腹状态下使用，无气腹状态则无法进行缝合操作，因此无法缝合最后一个注气建立气腹的穿刺孔，这样患者在术后容易产生穿刺孔疝等并发症，需要进一步治疗。
申请内容
针对现有技术的不足，本申请旨在提供一种用于外科手术的缝合器及穿刺器，解决了现 有技术中缝合器无法在无气腹状态进行缝合操作以缝合穿刺孔，使得术后容易产生穿刺孔疝等并发症的问题。
本申请通过以下技术方案实现：
一种用于外科手术的缝合器，包括：手柄部，用于提供握持；芯杆组件，芯杆组件的近端连接手柄部，芯杆组件的远端用于穿过穿刺孔，穿刺孔位于人体腹壁组织；缝合组件，缝合组件用于缝合穿刺孔，缝合组件的至少一部分设置于芯杆组件，缝合组件包括缝合线和缝合针，缝合线的端部连接至缝合针，缝合针运动带动缝合线缝合穿刺孔，缝合针的运动包括位于人体腹壁组织的第一运动和位于人体腹壁组织的内侧空间的第二运动；气囊组件，气囊组件包括气囊，气囊设置在芯杆组件的远端，气囊具有未充气的第一状态和充气的第二状态，在第一状态时气囊组件的直径小于在第二状态时气囊组件的直径，在第二状态时，气囊提供保护空间，缝合针的第二运动限制于保护空间内。
进一步的，缝合器还包括气体传输部，气体传输部与气囊连通，以使得气囊在第一状态和第二状态之间切换。
进一步的，气体传输部包括第一气道和第二气道，第一气道设置于芯杆组件并与气囊连通，第二气道设置于手柄部，第二气道连通第一气道，外界气源通过第一气道和第二气道为气囊充气。
进一步的，气囊为至少两个，至少两个气囊绕芯杆组件的周向间隔设置，在第二状态时，相邻两个气囊之间形成保护空间。
进一步的，在第二状态时，围成保护空间的相邻两个气囊之间的间距沿远离芯杆组件的方向逐渐减小，相邻两个气囊的径向边缘的端部抵接或存在间隙。
进一步的，在第二状态时，气囊呈扇形。
进一步的，气囊为一个，在第二状态时，气囊的近端形成向远端方向凹陷的凹陷部，凹陷部的内部空间为保护空间。
进一步的，气囊组件的气囊由不可形变材料制成，以使气囊充气后具有预设形状。
进一步的，不可形变材料为尼龙、橡胶中的至少一种。
进一步的，气囊组件还包括第一套管，气囊设置于第一套管的外壁，第一套管套设于芯杆组件的远端。
进一步的，气囊组件包括进气口，进气口设置于第一套管，进气口与气囊连通；芯杆组件包括第一气道，第一气道的远端开口连通于进气口。
进一步的，芯杆组件包括：芯杆，芯杆的外杆壁具有沿芯杆的轴向延伸的通气槽；第 二套管，第二套管套接在芯杆的外部，以使通气槽与第二套管之间形成第一气道。
进一步的，通气槽的远端位于芯杆的最远端的近侧，第二套管套接于芯杆并且第二套管避让通气槽的远端的至少一部分，以在通气槽的远端处形成第一气道的远端开口。
进一步的，手柄部包括第二气道，第二气道连通第一气道，第二气道的一端为充气口，充气口能够与气源连接，以对气囊充气。
进一步的，缝合器还包括储线组件，储线组件与芯杆组件的远端连接，储线组件用于容置至少部分缝合线；第一套管远端的外管壁设置有沿轴向延伸的导线槽，缝合线的端部穿过导线槽与缝合针连接。
进一步的，缝合器还包括储线组件，储线组件与芯杆组件的远端连接，储线组件用于容置至少部分缝合线，储线组件的外表面设置有切割刃，切割刃用于形成穿刺孔。
本申请还提供了一种穿刺器，包括：上述的缝合器；套管组件，缝合器伸入套管组件内。
与现有技术相比，本申请的有益效果在于：通过在芯杆组件的远端设置气囊，充气后的气囊撑开人体脏器组织，同时提供保护空间，使得缝合针的运动限制在保护空间内，避免缝合针在缝合人体腹壁组织过程中误伤人体脏器组织，从而使得缝合器在无气腹状态下也能够进行缝合操作，进而有效避免因微创手术穿刺孔造成的穿刺孔疝，有效减少患者痛苦，利于患者的术后康复。
附图说明
图1是本申请第一具体实施方式提供的用于外科手术的缝合器的爆炸图；
图2是本申请第一具体实施方式提供的用于外科手术的缝合器在气囊未打开时的结构示意图；
图3是本申请第一具体实施方式提供的用于外科手术的缝合器在气囊打开时的结构示意图；
图4是本申请第一具体实施方式提供的气囊组件的结构示意图；
图5是本申请第一具体实施方式提供的气囊组件的一个角度的截面图；
图6是本申请第一具体实施方式提供的气囊组件的另一个角度的截面图；
图7是本申请另一个具体实施方式提供的气囊组件的结构示意图；
图8是本申请另一个具体实施方式提供的气囊组件的一个角度的截面图；
图9是本申请第一具体实施方式提供的用于外科手术的缝合器在缝合针进入保护空 间时的结构示意图；
图10是图9所示的A处的局部放大图；
图11是本申请第一具体实施方式提供的用于外科手术的缝合器在缝合针穿入人体腹壁组织时的结构示意图；
图12是本申请第一具体实施方式提供的缝合线在人体腹壁组织中的运动轨迹示意图；
图13是本申请第一具体实施方式提供的用于外科手术的缝合器的截面图；
图14是本申请第二具体实施方式提供的用于外科手术的缝合器在气囊未打开时的结构示意图；
图15是本申请第二具体实施方式提供的用于外科手术的缝合器在气囊打开时的结构示意图；
图16是本申请第二具体实施方式提供的气囊组件的一个角度的截面图；
图17是本申请第三具体实施方式提供的穿刺器在气囊未打开时的结构示意图；
图18是本申请第三具体实施方式提供的穿刺器在气囊打开时的结构示意图。
其中，上述附图包括以下附图标记：
10、手柄部；11、第二气道；12、充气口；20、芯杆组件；21、第一气道；22、芯杆；221、通气槽；222、中空腔；223、第一出针口；224、第一留针口；225、容置槽；23、第二套管；231、第二留针口；30、缝合组件；31、缝合线；32、缝合针；321、缝合针头；322、缝合臂；323、连接部；33、传动件；40、气囊组件；41、气囊；42、第一套管；421、进气口；422、中套管；423、边套管；424、导线槽；425、第二出针口；60、储线组件；70、驱动组件；71、缝合按钮；72、驱动杆；80、套管组件；90、人体腹壁组织；100、保护空间；110、穿刺孔。
具体实施方式
为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本申请进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本申请，并不用于限定本申请。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
需要理解的是，本文所用术语“近端”和“远端”是相对于操纵缝合器的临床医生而言的。术语“近端”是指靠近临床医生的部分，术语“远端”则是指远离临床医生的 部分。即靠近手柄部10的一端为近端，靠近储线组件60的一端为远端。然而，缝合器可以在许多方向和位置使用，因此这些表达相对位置关系的术语并不是受限和绝对的。
在本申请中，除非另有明确的规定和限定，“相连”、“连接”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸地连接，还可以是可运动地连接，或成一体；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系如抵接。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本申请中的具体含义。需要说明的是，在“相连”、“连接”前有限定语时，其具有相应限定语所限定的含义，只排除明显需要排除的情形，不排除其它可能的情形，如“可拆卸地连接”指的是可拆卸式的连接，不包括成一体，但可运动连接等并不排除在外。
实施方式一
请参阅图1至图9、图11所示，本实施方式提供一种用于外科手术的缝合器，包括手柄部10、芯杆组件20、缝合组件30和气囊组件40。手柄部10用于提供握持。芯杆组件20的近端连接手柄部10，芯杆组件20的远端用于穿过穿刺孔110。缝合组件30用于缝合穿刺孔110，缝合组件30的至少一部分设置于芯杆组件20。缝合组件30包括缝合线31和缝合针32，缝合线31的端部连接至缝合针32，缝合针32运动带动缝合线31缝合穿刺孔110，缝合针的运动包括位于人体腹壁组织的第一运动和位于人体腹壁组织的内侧空间的第二运动。气囊组件40包括气囊41，气囊41设置在芯杆组件20的远端。气囊41具有未充气的第一状态和充气的第二状态。在第一状态时，芯杆组件20和气囊组件40能够穿过穿刺孔110或从穿刺孔110移出。在第二状态时，气囊41提供保护空间100，缝合针32的第二运动限制于保护空间100内。其中，在第一状态时气囊组件40的直径小于在第二状态时气囊组件40的直径。当然，可以理解的是，气囊组件40的直径实际为气囊41的直径。需要说明的是，气囊41的直径是指气囊41在径向上的一端与另一端之间的最大距离。
具体的，气囊组件40的气囊41充气后撑开位于人体腹壁组织90内侧空间且位于气囊41周围的人体脏器组织以在气囊41所在的区域内形成保护空间100。缝合操作时，缝合针32由芯杆组件20内逐渐伸出并在保护空间100内沿弧形轨迹带动缝合线31从人体腹壁组织90的内侧壁穿入人体腹壁组织90内，而后由穿刺孔110的孔壁处穿入穿刺孔110内，缝合针32在人体腹壁组织的内侧空间的第二运动位于保护空间内，缝合针32的穿入人体腹壁组织90后的运动为第一运动，即缝合针先执行第二运动后执行第一运动。穿刺孔110是利 用其它锋利和尖锐的外科器械在人体腹壁组织90上穿刺形成的贯穿人体腹壁组织90的孔状的伤口，人体腹壁组织90具备一定厚度，包括内侧壁和相对的外侧壁，外侧壁即皮肤，人体脏器组织位于人体腹壁组织90的内侧空间，该内侧空间是指位于人体腹壁组织90的内侧壁以内的空间，非人体腹壁组织90的厚度。通过在芯杆组件的远端设置气囊，充气后的气囊撑开人体脏器组织，同时提供保护空间，使得缝合针的第二运动限制在保护空间内，避免缝合针在缝合过程中误伤人体脏器组织，从而使得缝合器在无气腹状态下也能够进行缝合操作，进而有效避免因微创手术穿刺孔造成的穿刺孔疝，有效减少患者痛苦，利于患者的术后康复。
请参阅图1，缝合器还包括气体传输部，气体传输部与气囊41连通，以使得气囊41在第一状态和第二状态之间切换，气体传输部包括下述的第一气道21和第二气道11。关于第一气道21和第二气道11的结构，将在下文展开详细描述。
请参阅图3，气囊41为至少两个，至少两个气囊41绕芯杆组件20的周向间隔设置，在第二状态时，也就是气囊41充气后，相邻两个气囊41之间形成保护空间100。在本实施方式中，气囊41为两个，两个气囊41绕芯杆组件20的周向间隔设置，两个气囊41充气后，形成相对的两个保护空间100，如图4和图5所示。如图5所示，保护空间100的侧壁没有严格沿着芯杆组件20的径向延伸，因此，气囊41充气后形成的保护空间不是标准的扇形。可选地，保护空间100可以设置为标准的扇形。两个气囊41充气后大致呈扇形，包括图5所示的形状，也包括标准的扇形。此时，围成保护空间的两个气囊之间的间距沿远离芯杆组件20的方向(即径向)不变或者逐渐增加。相应的，缝合针32也为两个，每个缝合针32分别一一对应地进入一个保护空间100并沿弧形轨迹穿入人体腹壁组织90，在腹壁组织内运动，然后从穿刺孔110的孔壁处穿出，从而实现对穿刺孔110的缝合。
在本申请具体实施方式中，气囊41充气后，在径向上，气囊41的外表面与芯杆组件20之间的距离大于缝合针32在运动过程中与芯杆组件20之间的最大距离，在轴向上，气囊41的远端表面与人体腹壁组织90的内侧壁之间的距离大于缝合针32从芯杆组件20伸出时与人体腹壁组织90的内侧壁之间的距离。通过上述设置，使得保护空间100能够完全容置缝合针32的在人体腹壁组织90的内侧空间的运动轨迹，使得缝合针32在穿入人体腹壁组织90之前一直在保护空间100内运动，从而避免误伤人体的其他组织或器官，进而有效保护人体的组织或器官，如人体脏器组织。
在另一个具体实施方式中，在第二状态时，围成保护空间100的相邻两个气囊41之间的间距沿远离芯杆组件20的方向(径向)逐渐减小，相邻两个气囊41的径向边缘的 端部抵接，有效防止器官组织进入该保护空间，当然，也可以是相邻两个气囊41的径向边缘的端部之间互相靠近但存在间隙，如图7和图8所示，该间隙较小也能够有效防止器官组织进入该保护空间。
在本申请具体实施方式中，气囊组件40的气囊41由不可形变材料制成，以使气囊41充气后具有预设形状，从而使得形成的保护空间100具有稳定性。如果气囊41不具有预设形状，则在不同注气状态下会大小不一，既可能挤占保护空间100，也可能被缝合针32扎破。具体的，不可形变材料可以为尼龙、橡胶中的至少一种。
请参阅图1至图11，气囊组件40还包括第一套管42。气囊41设置于第一套管42的外壁，第一套管42套设于芯杆组件20的远端，从而气囊组件40以套设的方式设置于芯杆组件20的远端，这样的安装方式简单牢固。在本实施方式中，气囊41整体设置于第一套管42的外壁，具体的，在第一状态，也就是未充气的状态下，气囊41整体吸瘪后贴覆在第一套管42的外表面上。此时气囊41的直径稍大于第一套管42的直径。在第二状态，也就是充气后的状态下，气囊41从第一套管42的外壁上向外扩充，从而形成预设的形状。显然，气囊41在第二状态下的直径大于在第一状态下的直径。气囊41的边缘均连接至第一套管42的外壁，使得气囊41与第一套管42密封连接。优选地，气囊41和第一套管42为一体成型结构。第一套管42整体套设于芯杆组件20。
请参阅图4，第一套管42包括在轴线方向连接的中套管422和边套管423。气囊41设置于中套管422，进气口421设置于中套管422。其中，边套管423包括分别位于中套管422的近端和远端的上套管和下套管。具体的，中套管422在轴线方向具有上边缘和下边缘，上边缘和下边缘分别连接气囊41的面的边缘，以此来划分上套管、中套管422和下套管。通过设置边套管423，增加了气囊组件安装的稳定性。进一步的，当进气口421设置在第一套管42的中套管422时，上套管和下套管(即边套管423)保证了气囊组件40安装于芯杆组件20的气密性，避免漏气。在一个未示出的实施方式中，第一套管42不具有上套管或下套管，或者不具有边套管423，相对的，安装稳定性和气密性减弱。
请参阅图5至图6，气囊组件40包括如上进气口421。进气口421设置于第一套管42，具体地，进气口421贯通第一套管42的中套管422，并且与气囊41连通。请参阅图13，芯杆组件20包括第一气道21，第一气道21的远端开口位于芯杆22的表面(注：实际是这样的吗)并连通进气口421。具体的，进气口421与第一气道21的远端开口对应连通并与第一气道21的远端开口的形状相适配。
请参阅图1，芯杆组件20包括芯杆22和第二套管23。芯杆22的外杆壁具有沿芯杆22的轴向延伸的通气槽221。第二套管23套接在芯杆22的外部，以使通气槽221与第二套管23之间形成上述的第一气道21。具体的，第一套管42套设于芯杆22的远端并且与第二套管23和芯杆22的远端密封连接。安装缝合器时，先将第二套管23与芯杆22嵌套并使第二套管23的近端与芯杆22的近端平齐，从而留出第一气道21的远端开口，从芯杆22的远端套入第一套管42，第一套管42的进气口421与第一气道21的远端开口的位置相对应后，第一套管42的一部分覆盖住第二套管23的远端，且除了留出第一气道21的远端开口以外第二套管23的远端与芯杆22密封连接，从而使得第一套管42的两端均实现密封，此时气体仅能够通过通气槽221、第一气道21的远端开口导入至第一套管42的进气口421处，从而保证对气囊41充气时不漏气。
在本申请具体实施实施方式中，第二套管23由薄膜材质制成，因此均具有较薄的厚度。在保证第二套管23对芯杆22的密封作用下，能够减小第二套管23的重量使得整个缝合器轻便灵活，便于使用。
请参阅图1，通气槽221的远端没有延伸到芯杆22的最远端，也就是说，通气槽221的远端位于芯杆22最远端的近侧。第二套管23套接于芯杆22时第二套管23避让通气槽221的远端的至少一部分，以在通气槽221的远端处形成第一气道21的远端开口。具体的，第二套管23的长度小于通气槽221的长度，第二套管23与芯杆22嵌套后，会使得第二套管23的远端与通气槽221的远端之间存在未封闭的一段槽口，从而通气槽221的远端处的该槽口形成第一气道21的远端开口，用于与气囊组件40连通。通气槽221的近端贯通至芯杆22的近端的边缘处，这样通气槽221的近端作为第一气道21进气端。
图2为本申请具体实施方式提供的缝合器在气囊41未打开时的结构示意图。气囊组件40由薄膜材质制成，因此具有较薄的厚度，便于缝合器的远端穿过穿刺孔110进入人体腹壁组织90的下方。当气囊41处于第一状态时，气囊41与第一套管42贴合，且气囊41通过第一套管42贴合在芯杆22的外表面，此时气囊41和第一套管42相对于芯杆22只有较薄的厚度，因此能够减小摩擦阻力，便于缝合器进入人体内。图3为本申请具体实施方式提供的缝合器在气囊41打开时的结构示意图。气囊41处于第二状态时，气囊41向外膨胀打开，气囊41的外表面与芯杆组件20之间具有一定距离，从而形成保护空间100。
图9为本申请具体实施方式提供的缝合器在缝合针32进入保护空间100时的结构示意图。芯杆22具有中空腔(图中未示出)，且芯杆22的远端的外杆壁还设置有与中空腔连通的第一出针口223。第一套管42具有与第一出针口223对应的第二出针口425，当气囊组件40套设 在芯杆组件20的远端后，第一出针口223与第二出针口425重合。缝合针32容置在中空腔内并能够穿过第一出针口223、第二出针口425运动至保护空间100内。芯杆22的远端的外杆壁还设置有与第一出针口223间隔设置的第一留针口224，第二套管23具有与第一留针口224对应的第二留针口231，当第二套管23嵌套在芯杆22后，第一留针口224与第二留针口231重合。具体的，缝合针32的运动方向为由远端向近端运动，因此第一留针口224相对于第一出针口223靠近芯杆22的近端设置。
在本申请具体实施方式中，为了与两个缝合针32配合使用，第一出针口223为两个且相对设置，相应的，第二出针口425也为两个且相对设置。第一留针口224为两个且相对设置，相应的，第二留针口231也为两个且相对设置。
请参阅图1至图3、图9、图11和图13，缝合器还包括储线组件60。储线组件60与芯杆组件20的远端连接，储线组件60用于容置缝合线31的至少一部分。在一具体的实施方式中，储线组件60为尖端朝向远端的锥形，储线组件60的外表面设置有切割刃，切割刃用于形成穿刺孔110。关于储线组件60结构，将在下文展开详细描述。
请参阅图1、图4和图9，边套管423的外管壁设置有沿第一套管42的轴向延伸的导线槽424，缝合线31的端部穿过导线槽424与缝合针32连接。具体的，缝合线31的端部穿过导线槽424伸入第二出针口425内，以与缝合针32连接。相应的，第一套管42具有导线槽424处的区域向第一套管42内凹入，芯杆22的外杆壁还具有沿芯杆22的轴向延伸的容置槽225，第一套管42向内凹入的部分嵌入至容置槽225内。这样气囊组件40套设在芯杆组件20的远端后，第一套管42在导线槽424处与芯杆22正好适配。具体的，容置槽225的一端与第一出针口223连通，另一端位于芯杆22的最远端。可以理解的是，容置槽225也为两个且相对设置，相应的，导线槽424也为两个且相对设置，缝合线31为一根线，缝合线31的中间部分存储在储线组件60内，缝合线31的两端从储线组件60伸出并分别穿过两个导线槽424，从而与位于第一出针口223处的缝合针32连接。通过设置导线槽424和容置槽225，缝合线31能够容置在导线槽424内，从而不增加芯杆组件20的直径，因此，一方面能够减小摩擦阻力以便于缝合器直接深入进入人体内，另一方面，缝合器与套管组件80配合使用时，不增加套管组件80的中空腔的内径。当芯杆22具有容置槽225时，在芯杆22的远端套设薄膜材料的第一套管42时，就可以使得薄膜材料的第一套管42紧密的贴合在芯杆22的外表面，这样可以避免不必要的漏气，另外，通过工艺处理即如热熔，将薄膜材料的第一套管42贴合容置槽225以在薄膜材料的第一套管42上形成导线槽424。
图10是图9所示的A处的局部放大图。缝合针32包括缝合针头321和缝合臂322，缝 合针头321与缝合臂322可拆卸地连接。进一步地，缝合针32还包括连接部323，连接部323与缝合针头321可拆卸地连接，且连接部323与缝合臂322固定连接。具体的，连接部323为沿缝合臂322的长度方向延伸的圆柱体，其外径小于缝合臂322的外径。缝合线31与缝合针头321连接，缝合针32从穿刺孔110的孔壁穿出后经第二留针口231、第一留针口224进入芯杆组件20内。芯杆组件20内设置有针头接收件，针头接收件位于第一留针口224内，缝合针头321进入第一留针口224内后与针头接收件固定连接。具体的，针头接收件包括接收部、卡持部和接收片。卡持部位于接收部的两侧，接收片位于接收部中央，接收部和卡持部一体成型。卡持部具有弯折的形状，接收片为弹性网格片或者具有镂空结构的弹性镂空片，用于卡持缝合针头321。接收片位于第一留针口224内，缝合针头321从穿刺孔110的孔壁穿出后，穿入第二留针口231、第一留针口224内而被接收片卡持。相应的，另一个缝合针32的缝合针头321以同样的方式被针头接收件的接收片同步卡持，从而实现接收缝合针头。关于针头接收件的具体结构以及接收针头的方式可参考公开号为CN111870321A、CN111870292A的已知实施例的描述，在此不作赘述。
此时缝合针32回缩，缝合针头321与缝合臂322脱离以使缝合针头321滞留在芯杆组件20内，缝合臂322经第二出针口425、第一出针口223、保护空间100回退至芯杆组件20内。
图11为本申请具体实施方式提供的缝合器在缝合针32穿入人体腹壁组织90时的结构示意图。缝合针32从第一出针口223处伸出并进入气囊41形成的保护空间100内，然后沿弧形轨迹继续向近端运动从而穿入人体腹壁组织90内。
图12为本申请具体实施方式提供的缝合线31在人体腹壁组织90中的运动轨迹示意图。缝合线31在缝合针头321的带动下运动，因此图10也是缝合针头321的运动轨迹示意图。当需要缝合穿刺孔110时，两个缝合针头321分别一一对应地从一个第一出针口223处伸出并进入一个保护空间100内，两个缝合针头321分别从A点和B点穿入人体腹壁组织90内。具体的，A点和B点分别位于穿刺孔110的相对侧。随着缝合臂322的继续运动，缝合针头321继续带动缝合线31在人体腹壁组织90内移动，然后两个缝合针头321分别从C点和D点穿出并分别进入两个第一留针口224内。具体的，C点和D点分别位于穿刺孔110的内壁的相对侧。
请参阅图13，缝合器还包括驱动组件70。驱动组件70包括缝合按钮71和与缝合按钮71可驱动地连接的驱动杆72，缝合按钮71设置在手柄部10的近端，芯杆组件20具有中空腔222，驱动杆72设置在中空腔222内并与缝合针32可驱动地连接，以带动缝合针32缝合穿刺孔110。缝合组件30还包括传动件33，缝合针32与传动件33连接，传动件33与驱动 杆72可驱动地连接，从而带动缝合针32运动。具体的，传动件33包括旋转轴和套设于旋转轴的齿轮。驱动杆72设置有与齿轮啮合的齿条段，当驱动杆72沿芯杆组件20的轴向移动时，齿条段带动齿轮旋转，进而带动旋转轴旋转。缝合臂322的远离缝合针头321的一端与旋转轴连接，且缝合臂322为弧形，从而在旋转轴的带动下沿弧形轨迹转动。当需要缝合穿刺孔110时，按压缝合按钮71，驱动杆72沿轴向向远端移动，带动缝合针32向近端转动，从而从第一出针口223处伸出并进入保护空间100内，进而穿入人体腹壁组织90内。同样的，关于驱动组件、缝合组件的具体结构可参考公开号为CN111870321A、CN111870292A的已知实施例的描述，在此不作赘述。
在本申请具体实施方式中，储线组件60包括收纳结构和中空的外罩壳。收纳结构固定连接于芯杆22的最远端，收纳结构容置于外罩壳内并且收纳结构与外罩壳之间的环形空间形成收纳空间，缝合线31收纳于收纳空间内。具体的，收纳结构包括绕线部，储线组件具有初始状态和释放状态，当处于初始状态时，缝合线31缠绕于绕线部，使缝合线31整体收纳在收纳空间内。外罩壳与驱动杆72可驱动地连接，当驱动杆72沿轴向向远端移动时，带动外罩壳也向远端移动，使得外罩壳与收纳结构脱离，此时储线组件由初始状态变为释放状态，收纳空间外露，由于缝合线31本身具有一定弹性，从而使得缝合线31从收纳空间弹出而外露。同样的，关于储线组件的具体结构以及储线组件与驱动杆的连接方式和驱动方式可参考公开号为CN111870292A的已知实施例的描述，在此不作赘述。
请继续参阅图13，手柄部10包括设置于手柄部10内部的第二气道11，第二气道11连通第一气道21，第二气道11的一端为充气口12，充气口12设置于手柄部10的外表面，充气口12能够与气源连接，以对气囊41充气。手柄部10还包括充气阀，充气阀设置于充气口12处。具体的，充气阀为止回阀，在常压状态下保持封闭，只有在具有一定压力的外部气体进入充气阀时，充气阀才会打开，从而避免漏气。
实施方式二
请参阅图14至图16，本实施方式提供了一种缝合器。本实施方式中的缝合器与实施方式一中的缝合器的区别在于气囊组件40的结构不同。
图14为本申请具体实施方式二提供的缝合器在气囊41未打开时的结构示意图。本申请具体实施方式二的气囊41同样具有未充气的第一状态和充气的第二状态。当气囊41处于第一状态时，气囊41与第一套管42贴合，且气囊41通过第一套管42贴合在芯杆22的外表面，此时气囊41和第一套管42相对于芯杆22只有较薄的厚度，因此能够减小摩擦阻力，便于缝合器进入人体内。图15是本申请具体实施方式提供的缝合器在气囊41打开时的结构 示意图。当气囊41处于第二状态时，气囊41向外膨胀打开，气囊41充气后为碗状且碗口朝向芯杆组件20的近端，且碗状的气囊41的碗内空间为保护空间100。
在本申请具体实施方式中，碗状的气囊41的内壁与芯杆组件20之间的距离大于缝合针32在运动过程中与芯杆组件20之间的最大距离。通过上述设置，使得保护空间100能够完全容置缝合针32的运动轨迹，使得缝合针32在穿入人体腹壁组织90之前一直在保护空间100内运动，从而避免误伤人体的其他组织或器官，进而有效保护人体脏器组织。
在本申请具体实施方式中，气囊41为一个，第一套管42与气囊41的底部连通，在第二状态时，气囊41的近端形成向内(即向远端方向)凹陷的凹陷部，凹陷部的内部空间为保护空间100，如图14所示。
实施方式三
请参阅图17至图18，本申请具体实施方式还提供了一种穿刺器，包括上述的缝合器和套管组件80，缝合器伸入套管组件80内。上述的缝合器不具备穿刺功能，此时可由其它锋利和尖锐的外科器械进行穿刺。在本申请另外的具体实施方式中，储线组件60为尖端朝向远端的锥形，即形成穿刺尖端。具体地，储线组件60的外罩壳为朝向远端的锥形，其形成穿刺尖端，储线组件60的其它结构与前述的储线组件相同。储线组件60的外表面设置有切割刃，切割刃用于形成穿刺孔110。具体地，储线组件60的外罩壳的外表面设置有切割刃。
图17是本申请具体实施方式提供的穿刺器在气囊41未打开时的结构示意图。图18为本申请具体实施方式提供的穿刺器在气囊41打开时的结构示意图。本申请具体实施方式的穿刺器既具有穿刺功能，也具有缝合功能。手术时，医生先在患者的腹部划开一个小切口，利用本申请提供的缝合器的穿刺尖端穿刺人体组织形成穿刺孔110，此时气囊41未打开。将套管组件80下端部分插入人体体内，通过按压插块组件(图中未示出)将缝合器与套管组件80分离，并从套管组件80中拔出缝合器，此时气囊41也未打开。然后将外科手术器械伸入套管组件80中，进行手术，待手术完毕后，取出外科手术器械，将缝合器重新插入套管组件80中，通过插块组件使得缝合器与套管组件重新卡接，启动缝合操作。当需要缝合穿刺孔110时，将缝合器的远端通过穿刺孔110深入人体腹壁组织90的内侧，使得气囊41已完全位于人体腹壁组织90的内侧，向气囊41注气使气囊41打开，然后将缝合器向近端移动，打开的气囊41能够抵住穿刺孔110周围的人体腹壁组织90的内侧壁，从而起到限位作用，缝合器不能再继续向近端移动，处于最佳缝合 位置。按压缝合按钮71，缝合针32从第一出针口223伸出并进入保护空间100内，进而穿入穿刺孔110相对侧的人体腹壁组织90内。在缝合针32开始运动前，储线组件60解除对缝合线31的收纳使得缝合针32可带动缝合线31穿过人体腹壁组织90，解除方式不在此赘述。当缝合针头321进入第一留针口224，且缝合臂322退回第一出针口223后，对气囊41进行抽气，使得气囊41回到贴合状态即第一状态，从而将缝合器取出，缝合器带动留在第一留针口224中的缝合针头321，进而将连接于缝合针头321的缝合线31的两端自穿刺孔取出，如图12所示。在将缝合器向近端移动取出的过程中，缝合线31在穿刺孔110下方的部分被抽动并逐渐缩短，使得穿刺孔110收紧，最终在收紧的穿刺孔110上方将缝合线31的两端穿插打结，剪去多余的缝合线31，则穿刺孔110缝合完成。
综上，根据本申请的穿刺器，通过在芯杆组件20的远端设置气囊41，充气后的气囊41撑开人体脏器组织，不再需要建立气腹的设备，缝合器的使用不再受限于气腹状态，使用方便、成本降低；同时提供保护空间100，使得缝合针32的运动限制在保护空间100内，避免缝合针32在缝合人体腹壁组织过程中误伤人体脏器组织，从而使得缝合器在无气腹状态下也能够进行缝合操作，进而有效避免因微创手术穿刺孔造成的穿刺孔疝，有效减少患者痛苦，利于患者的术后康复。
应当理解，虽然本说明书按照实施方式加以描述，但并非每个实施方式仅包含一个独立的技术方案，说明书的这种叙述方式仅仅是为清楚起见，本领域技术人员应当将说明书作为一个整体，各实施方式中的技术方案也可以经适当组合，形成本领域技术人员可以理解的其他实施方式。
上文所列出的一系列的详细说明仅仅是针对本申请的可行性实施方式的具体说明，它们并非用以限制本申请的保护范围，凡未脱离本申请技艺精神所作的等效实施方式或变更均应包含在本申请的保护范围之内。

Claims (17)

  1. 一种用于外科手术的缝合器，其特征在于，包括：
    手柄部，用于提供握持；
    芯杆组件，所述芯杆组件的近端连接所述手柄部，所述芯杆组件的远端用于穿过穿刺孔，所述穿刺孔位于人体腹壁组织；
    缝合组件，所述缝合组件用于缝合所述穿刺孔，所述缝合组件的至少一部分设置于所述芯杆组件，所述缝合组件包括缝合线和缝合针，所述缝合线的端部连接至所述缝合针，所述缝合针运动带动所述缝合线缝合所述穿刺孔，所述缝合针的运动包括位于人体腹壁组织的第一运动和位于所述人体腹壁组织的内侧空间的第二运动；
    气囊组件，所述气囊组件包括气囊，所述气囊设置在所述芯杆组件的远端，所述气囊具有未充气的第一状态和充气的第二状态，在所述第一状态时所述气囊组件的直径小于在所述第二状态时所述气囊组件的直径，在所述第二状态时，所述气囊提供保护空间，所述缝合针的所述第二运动限制于所述保护空间内。
  2. 根据权利要求1所述的缝合器，其特征在于，所述缝合器还包括气体传输部，所述气体传输部与所述气囊连通，以使得所述气囊在所述第一状态和所述第二状态之间切换。
  3. 根据权利要求2所述的缝合器，其特征在于，所述气体传输部包括第一气道和第二气道，所述第一气道设置于所述芯杆组件且与所述气囊连通，所述第二气道设置于所述手柄部，所述第二气道连通所述第一气道，外界气源通过所述第一气道和所述第二气道为所述气囊充气。
  4. 根据权利要求1所述的缝合器，其特征在于，所述气囊为至少两个，至少两个所述气囊绕所述芯杆组件的周向间隔设置，在所述第二状态时，相邻两个所述气囊之间形成所述保护空间。
  5. 根据权利要求4所述的缝合器，其特征在于，在所述第二状态时，围成所述保护空间的相邻两个所述气囊之间的间距沿远离所述芯杆组件的方向逐渐减小，相邻两个所述气囊的径向边缘的端部抵接或存在间隙。
  6. 根据权利要求4所述的缝合器，其特征在于，在所述第二状态时，所述气囊呈扇形。
  7. 根据权利要求1所述的缝合器，其特征在于，所述气囊为一个，在所述第二状态 时，所述气囊的近端形成向远端方向凹陷的凹陷部，所述凹陷部的内部空间为所述保护空间。
  8. 根据权利要求1所述的缝合器，其特征在于，所述气囊组件的气囊由不可形变材料制成，以使所述气囊充气后具有预设形状。
  9. 根据权利要求6所述的缝合器，其特征在于，所述不可形变材料为尼龙、橡胶中的至少一种。
  10. 根据权利要求1所述的缝合器，其特征在于，所述气囊组件还包括第一套管，所述气囊设置于所述第一套管的外壁，所述第一套管套设于所述芯杆组件的远端。
  11. 根据权利要求10所述的缝合器，其特征在于，所述气囊组件还包括进气口，所述进气口设置于所述第一套管，所述进气口与所述气囊连通；
    所述芯杆组件包括第一气道，所述第一气道的远端开口连通所述进气口。
  12. 根据权利要求11所述的缝合器，其特征在于，所述芯杆组件包括：
    芯杆，所述芯杆的外杆壁具有沿所述芯杆的轴向延伸的通气槽；
    第二套管，所述第二套管套接在所述芯杆的外部，以使所述通气槽与所述第二套管之间形成所述第一气道。
  13. 根据权利要求12所述的缝合器，其特征在于，所述通气槽的远端位于所述芯杆的最远端的近侧，所述第二套管套接于所述芯杆并且所述第二套管避让所述通气槽的远端的至少一部分，以在所述通气槽的远端处形成所述第一气道的所述远端开口。
  14. 根据权利要求11所述的缝合器，其特征在于，所述手柄部包括第二气道，所述第二气道连通所述第一气道，所述第二气道的一端为充气口，所述充气口能够与气源连接，以对所述气囊充气。
  15. 根据权利要求11所述的缝合器，其特征在于，所述缝合器还包括储线组件，所述储线组件与所述芯杆组件的远端连接，所述储线组件用于容置至少部分所述缝合线；所述第一套管远端的外管壁设置有沿轴向延伸的导线槽，所述缝合线的端部穿过所述导线槽与所述缝合针连接。
  16. 根据权利要求1所述的缝合器，其特征在于，所述缝合器还包括储线组件，所述储线组件与所述芯杆组件的远端连接，所述储线组件用于容置至少部分所述缝合线，所述储线组件的外表面设置有切割刃，所述切割刃用于形成所述穿刺孔。
  17. 一种穿刺器，其特征在于，包括：权利要求1至14中任一项所述的缝合器；套管组件；所述缝合器伸入所述套管组件内。
PCT/CN2022/136994 2021-12-09 2022-12-06 用于外科手术的缝合器及穿刺器 WO2023104045A1 (zh)

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