WO2019128772A1 - Neostomy device - Google Patents

Neostomy device Download PDF

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Publication number
WO2019128772A1
WO2019128772A1 PCT/CN2018/121716 CN2018121716W WO2019128772A1 WO 2019128772 A1 WO2019128772 A1 WO 2019128772A1 CN 2018121716 W CN2018121716 W CN 2018121716W WO 2019128772 A1 WO2019128772 A1 WO 2019128772A1
Authority
WO
WIPO (PCT)
Prior art keywords
grasping
distal end
catheter body
cutting
control handle
Prior art date
Application number
PCT/CN2018/121716
Other languages
French (fr)
Chinese (zh)
Inventor
刘鹏
Original Assignee
先健科技(深圳)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 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Publication of WO2019128772A1 publication Critical patent/WO2019128772A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3209Incision instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B17/3423Access ports, e.g. toroid shape introducers for instruments or hands
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B17/3423Access ports, e.g. toroid shape introducers for instruments or hands
    • A61B2017/3425Access ports, e.g. toroid shape introducers for instruments or hands for internal organs, e.g. heart ports

Definitions

  • the invention relates to the field of interventional medical devices, in particular to a ostomy device.
  • Heart failure is becoming the most important cardiovascular disease in the world.
  • Heart failure can be divided into diastolic heart failure and systolic heart failure.
  • Diastolic heart failure refers to a decrease in ventricular relaxation and a decrease in filling pressure in the case of normal ventricular systolic function, resulting in pulmonary circulation and systemic congestion syndrome.
  • Diastolic heart failure causes an increase in pressure in the left atrium and pulmonary veins, preventing normal flow of oxygenated blood.
  • Clinical data indicate that a small hole is formed in the interatrial septum of patients with diastolic heart failure, forming a left-to-right shunt, which is beneficial to reduce the pressure on the left atrium of patients with heart failure. Improve the symptoms of patients with heart failure.
  • a method for treating heart failure is to first expand the opening to a larger size by a balloon expansion method after the atrial septal tissue is puncture, but the tissue tends to rebound after the balloon is withdrawn to cause the opening to shrink.
  • the atrial septal tissue is excised by means of blade resection, but the open tissue formed by this method is implicated and irregular, the shape is difficult to control, and the operation time is long.
  • the technical problem to be solved by the present invention is to provide a room spacing ostomy device which is simple in operation, high in reliability, regular in opening and stable in shape, in view of the defects of the prior art.
  • the present invention provides a ostomy apparatus comprising a grasping device, a cutting device, and a control handle for controlling the grasping device and the cutting device, the grasping device comprising a catheter body, a grasping portion, and a negative pressure a device, the negative pressure device is connected to the catheter body, the grasping portion is disposed in the catheter body; the cutting device comprises a cutting member, the cutting member is disposed at the distal end of the grasping member and the Between the distal end faces of the catheter body, the control handle controls movement of the cutting member.
  • the distal end of the grasping portion is provided with a grasping member, and the distal end of the grasping member does not exceed the distal end surface of the catheter body.
  • the gripping portion comprises at least two symmetrically disposed gripping members.
  • a distal end of the distal end of the grasping portion is further provided with a stopper, one end of the stopper is connected to the grasping member, and the other end is away from the grasping member and extends toward the inner wall of the catheter.
  • the stopper and the distal end of the gripping member form an angle ranging from 0 to 90 degrees.
  • the grasping member is gathered at a distal end in a natural state
  • the grasping device further includes a support portion, the proximal end of the support portion is connected to the control handle, and the support portion is disposed on the grasping portion.
  • the inner side of the take-up member has an open shape; and when the control handle controls the axial movement of the support portion toward the distal end, the distal end of the support portion abuts against the inner side of the grasping member, so that the grasping member is far away The end forms an opening.
  • the support portion includes a support member and a second connection member coupled to the proximal end of the support member, the support member supports the gripping member, the second connector is proximally connected to the Control handle connection.
  • the grasping member is provided with a limiting member, and a through hole is formed between the limiting member and the grasping member, and the distal end of the supporting member passes through the through hole.
  • the gripping member is provided with an anchoring unit.
  • the cutting device further includes a control wire, the distal end of the control wire is coupled to the cutting member, the proximal end of the control wire is coupled to the control handle, and the control handle passes the A control wire controls the movement of the cutting member.
  • the ostomy device provided by the present invention comprises a grasping device, a cutting device and a control handle for controlling the grasping device and the cutting device, the negative pressure device being connected to the catheter body to provide a negative pressure to the catheter body
  • the gripping portion includes a gripping member disposed within the catheter body and a restriction member axially movable within the catheter body.
  • the grasping device of the present invention is provided with a grasping portion, and the distal end of the grasping portion is provided with a grasping member, and the tissue to be cut is sucked into the catheter body by the action of the negative pressure device, and the control is passed through
  • the end control handle controls the movement of the restriction member, and the grasping member at the distal end of the grasping portion grasps the human body tissue sucked into the catheter body, and then tightens the cutting device through the control handle and energizes, and the cutting operation can be completed under the action of the control handle.
  • the grasping member at the distal end of the grasping portion is still in a folded state and can clamp the human tissue under cutting and withdraw it with the catheter to the outside of the body, in the process of withdrawing the ostomy device, cutting Human tissue does not fall into the body and poses a risk, and the opening formed by the ostomy device by electrical cutting is stable and does not retract.
  • the cutting member of the cutting device of the present invention is disposed between the distal end of the grasping member and the distal end surface of the catheter body rather than surrounding the outer side of the catheter body, which greatly reduces the size of the distal end of the ostomy device and allows access to smaller blood vessels.
  • Figure 1 is a schematic view showing the structure of a ostomy device of the present invention
  • FIG. 2a is a schematic view showing the internal structure of the distal end of the ostomy apparatus according to the first embodiment of the present invention
  • Figure 2b is an enlarged schematic view showing a portion of the structure of Figure 2a;
  • FIG. 3 is a schematic structural view of a cutting portion in a ostomy device according to a first embodiment of the present invention
  • FIG. 4a is a schematic view showing the internal structure of a distal end of a ostomy apparatus according to a second embodiment of the present invention.
  • Figure 4b is an enlarged schematic view showing a portion of the structure of Figure 4a;
  • Figure 5 is a schematic view showing a simplified structure of a grasping member in a ostomy apparatus according to a second embodiment of the present invention
  • Fig. 6 is a schematic cross-sectional view showing the grasping portion of the ostomy apparatus according to the second embodiment of the present invention.
  • distal and distal end are used as the orientation words, which are the conventional terms in the field of interventional medical devices, wherein “distal” means the end away from the operator during the operation, “Proximal” means the end that is close to the operator during the procedure.
  • the "axial direction” refers to the direction in which the distal end of the medical device is connected to the center of the proximal end, and the connection in the direction is the “central axial axis”; the “radial” refers to the direction perpendicular to the axial direction. .
  • the ostomy apparatus 100 of the present embodiment includes a cutting device 20, a grasping device 10, and a control handle 30.
  • the cutting device 20 includes a cutting portion 21 and a high frequency power source 22 for supplying power to the cutting portion 21, and the gripping device 10 includes a catheter body 11, a gripping portion 12, and a negative pressure source 13.
  • the cutting portion 21 is provided inside the catheter body 11 for cutting the body compartment spacer tissue in the catheter body 11 by the ostomy appliance 100.
  • the negative pressure source 13 is in communication with the catheter body 11 for forming a negative pressure in the catheter body 11 to adsorb the human body compartment tissue.
  • the grasping portion 12 is disposed at the distal end of the lumen of the catheter body 11 near the distal end of the catheter body 11, The body compartment spacer for inhaling the ostomy device 100 into the lumen of the catheter body 11.
  • the control handle 30 is disposed at the proximal end of the catheter body 11 and is coupled to the proximal end of the catheter body 11, and the control handle 30 is used to drive the movement of the various components of the ostomy appliance 100.
  • the catheter body 11 comprises two parts, and the proximal end portion of the catheter body 11 is provided with a plurality of reinforcing ribs 110, thereby forming a plurality of thin lumens 115 which are not connected to each other to increase
  • the hardness of the proximal end of the catheter body 11 improves the bending resistance of the catheter body 11.
  • the distal end portion of the catheter body 11 is hollow to form a single main lumen 111.
  • the catheter body 11 can be formed into a multi-cavity structure by a molding device, and the material of the catheter body 11 can be nylon, polytetrafluoroethylene or PEBAX.
  • the ribs 110 are in the form of sheets of equal thickness and are symmetrically distributed along the axis of the conduit 11, and the number may be 2 to 6, preferably 2 to 4.
  • the catheter body 11 is further provided with a lumen 116 coaxial therewith, and the outside of the lumen 116 is connected to the rib 110.
  • the reinforcing ribs 110 may not be provided, that is, the catheter body 11 is integrally designed as long as the wall thickness of the catheter body 11 is small.
  • the catheter body 11 can have a certain bending resistance.
  • the gripping portion 12 includes a gripping member 121, a restricting member 123, a fixing member 122, a first connecting member 126, and a tubular body 125.
  • the grasping member 121 is located at the distal end of the grasping portion 12, and is disposed coaxially with the catheter body 11, and the distal end surface of the grasping member 121 is retracted into the distal end surface of the catheter body 11.
  • the restricting member 123 is coaxially sleeved on the gripping member 121 for controlling the opening and closing of the distal end of the gripping member 121.
  • the first connecting member 126 is connected to the proximal end of the restricting member 123.
  • the first connecting member 126 passes through the lumen 116 and is connected to the control handle 30 at the proximal end for controlling the movement of the restricting member 123 in the axial direction.
  • the tubular body 125 is disposed on the inner wall of the catheter body 11 for fixing the grasping member 121.
  • a plurality of fixing members 122 are connected to the proximal end of the grasping member 121, and a plurality of clamping jaws 1211 are disposed at the distal end.
  • the plurality of fixing members 122 and the plurality of clamping jaws 1211 are connected by the shaft 1212.
  • the plurality of jaws 1211 are separated from each other from the proximal end to the distal end in a natural state, and the plurality of jaws 1211 can be gathered from each other under the constraint of an external force.
  • the linear distance between any two of the jaws 1211 is smaller than the inner diameter of the catheter body 11, thereby ensuring that the plurality of jaws 1211 can be accommodated in the catheter body 11 in a natural state.
  • a plurality of fixing members 122 are disposed at the proximal end of the grasping portion 12 and extend outward in the circumferential direction.
  • the proximal end of the fixing member 122 is a sheet-like structure, and the fixing member is fixedly connected with the tubular body 125 through the proximal-shaped sheet-like structure, so as to grasp The pickup 121 does not move relative to the catheter body 11 during operation.
  • the number of the fixing members 122 is 2-5, and the present embodiment is preferably 3.
  • the three fixing members 122 are evenly distributed on the circumference of the grasping member 121 along the axis. It can be understood that, in other embodiments, the fixing is fixed.
  • the pieces 122 can also be unevenly distributed.
  • the grasping portion 12 is fixed to the inner wall of the catheter body 11 by the fixing member 122.
  • the distal end of the grasping member 121 does not protrude to the catheter due to the bending of the catheter body 11. Outside the body 11, avoid scratching, cutting, or puncturing the human tissue.
  • the fixing member 122 can also be disposed at other positions of the grasping portion 12, and the shape of the fixing member 122 can also be other shapes, such as a column shape, a sheet shape, a barb shape, etc., only need It is ensured that the fixing member 122 can be fixedly attached to the tubular body 125.
  • the gripping members 121 are symmetrically disposed with respect to the central axis, and the number of the gripping members 121 may be 2-6, and the number of the embodiment is 2.
  • the number of the jaws 1211 of the grasping member 121 is four, and the four jaws 1211 are gradually separated from the proximal end to the distal end.
  • the clamping claw 1211 is provided with a plurality of anchoring units, and the anchoring unit may be a rib, a serration or the like. In this embodiment, the anchoring unit is a sawtooth.
  • the serrations are disposed on the inner side of the clamping jaws 1211 and can be symmetrically distributed or staggered.
  • the number of serrations is 1 to 10, preferably 4 to 8, and can be evenly arranged or unequally arranged.
  • the overall shape may be a triangular wave, a square wave, a sine wave or an arbitrary waveform, or a combination of two or more of the above.
  • the anchoring unit on the jaws 1211 may also omit.
  • jaws 1211 may be employed in place of the jaws 1211, for example, a grasping net, splint, etc., disposed at the distal end of the grasping member 121.
  • the restricting member 123 has a tubular shape as a whole, and the tube wall of the restricting member 123 is provided with a plurality of slots 1231 in the longitudinal direction.
  • the number of the slots 1231 is the same as the number of the fixing members 122. .
  • the restricting member 123 is sleeved on the gripping member 121, and a single fixing member 122 protrudes from a single slot 1231 of the restricting member 123, and the gripping member 121 protrudes from the distal opening of the restricting member 123.
  • the length of the restricting member 123 ranges from 3 to 8 mm, preferably from 4 to 6 mm, and is 5 mm in this embodiment.
  • the tubular body 125 is disposed on the inner wall of the distal end of the catheter body 11, and the distal end of the tubular body 125 is flush with the distal end of the catheter body 11 or is slightly contracted to the distal end of the catheter body 11.
  • the tube body 125 is used for fixing the gripping member 121.
  • the outer wall of the tube body 125 and the inner wall of the duct body 11 can be fixed by bonding.
  • the fixing member 122 of the gripping member 121 can be fixed to the inner wall of the tube body 125 by welding or bonding. Therefore, it is ensured that the grasping member 121 does not generate axial movement during the operation, and the distal end of the grasping member 121 is prevented from being exposed from the distal end of the catheter body 11 to scratch the human tissue.
  • the tube body 125 may not be disposed, and the polymer material may be sleeved on the fixing member 122, and directly connected to the inner wall of the catheter body 11 by heat fusion or adhesive bonding.
  • the material of the tube body 125 may be selected from a metal material such as a nickel-titanium alloy, a stainless steel or a cobalt-chromium alloy, which can be processed by mechanical wire cutting, cold-pressed by a metal ring, or by selective laser sintering. 3D printing technology is available.
  • the body shape of the tubular body 125 may be a circular, elliptical or combined profile.
  • the distal end of the first connecting member 126 is fixedly connected to the proximal end of the limiting member 123.
  • the proximal end of the first connecting member 126 is connected to the control handle 30, and the first connecting member 126 is controlled to move axially by the control handle 30, thereby controlling the limiting member 123. Axial movement.
  • the first connecting member 126 can also be omitted.
  • the proximal end of the restricting member 123 can be directly connected to the control handle 30.
  • the ostomy apparatus of the present embodiment is further provided with a stop member 124 adjacent the distal end portion of the grasping member 121.
  • One end of the stopper 124 is connected to the gripping member 121, and the other end extends away from the gripping member 121 toward the inner wall of the catheter body 11. Therefore, an angle is formed between the stopper 124 and the distal end of the gripping member 121, and the angle of the included angle ranges from 0 to 90°.
  • the cutting portion 21 of the present embodiment includes a cutting member 212 and a control wire 211.
  • the cutting member 212 is mounted on the angled structure formed by the stopper 124 and the gripping member 121.
  • the cutting member 212 has a substantially annular structure that is perpendicular to the axial direction of the catheter body 11.
  • the control wire 211 passes through a wall cavity (not shown) provided on the inner wall of the catheter body 11 and is connected to the cutting member 212 at the distal end and to the control handle 30 at the proximal end.
  • the control wire 211 can be moved proximally under the control of the control handle 30, while the cutting member 212 is first moved radially relative to the catheter body 11, and the cutting member 212 is partially received into the lumen wall cavity, thereby tightening through The object of the cutting member 212; after the cutting member 212 is partially received into the wall of the tube wall, the control wire 211 is further moved to the proximal end to drive the cutting member 212 to be axially moved into the wall portion of the tube wall, and further tightened through the cutting portion.
  • the cutting portion 21 of the present embodiment is made of a metal material having good electrical conductivity.
  • the stopper may not be provided.
  • the cutting member of the cutting portion is disposed between the distal end of the grasping member and the end surface of the catheter body, and the cutting member is attached to the inner wall of the catheter.
  • the stiffness of the material depends on the positional displacement of the ostomy device in the lumen of the human body.
  • the cutting member is disposed between the distal end of the grasping member and the end surface of the catheter body to ensure that the grasping member is not grasped when the cutting member is tightened. Together, the cutting reliability is higher.
  • the grasping device 10 and the cutting device 20 further include a negative pressure device 13 and a high frequency power source 22, respectively.
  • the vacuum device 13 is connected to the control handle 30 via a first connecting pipe 301, and the high frequency power source 22 is connected to the control handle 30 via a second connecting pipe 302.
  • the negative pressure device 13 is for adsorbing human tissue into the catheter body 11, and the high-frequency power source 22 is configured to pass a high-frequency current to the cutting portion 21 and form a circuit with a neutral electrode plate (not shown) of the patient's body surface. Thereby, the human tissue sucked by the catheter body 11 is cut.
  • the high frequency power source 22 has an operating frequency of 300 kHz to 5 MHz, preferably, the frequency range is 400 kHz to 1000 kHz, and the output power of the high frequency power source 22 is 0 to 300 w. Preferably, the power range is 50 to 100 w.
  • the working process of the ostomy device 100 during the atrial septum is further described below.
  • the catheter body 11 When the atrial septum is made by the ostomy apparatus 100 of the embodiment, the catheter body 11 is percutaneously punctured into the human body and reaches the heart. The distal end surface of the catheter body 11 abuts against the interatrial septum, and drives the negative pressure device 13 at a negative pressure. Part of the human tissue is sucked into the catheter body 11 under the action.
  • the control handle 30 is further operated to cause the first link member 126 to move the restricting member 123 to the distal end surface, and the jaws 1211 are gradually clamped in the radial direction of the catheter body 11.
  • the serrations on the jaws 1211 are capable of reversing the housing spacers so that the gripping members 121 hold the body tissue securely.
  • control wire 211 is pulled toward the proximal end by the control handle 30, so that the cutting portion 21 is gradually deformed, and under the action of the inner wall of the tube wall cavity, the cutting portion 21 is gradually squeezed and bound into a straight line, and is gradually accommodated in the tube wall cavity. .
  • the cutting portion 21 continuously enters the wall cavity, the human body spacer tissue sucked into the catheter body 11 will also be trapped by the cutting portion 21, and during the process of continuously tightening the cutting portion 21, the high frequency power source 22 can be used by the clinician.
  • a high-frequency current is delivered to the cutting portion 21, and a circuit is formed with a neutral electrode plate (not shown) of the patient's body surface, thereby excising the body atrial space tissue sucked by the catheter body 11.
  • the removed human body tissue is still clamped by the grasping member 121, and at the same time, due to the limiting action of the restricting member 123, the grasping member 121 is firmly clamped to the human body and is not cut by the movement, vibration, etc. of the ostomy device 100.
  • the body tissue is dropped, which improves the safety of the operation.
  • the cutting member of the cutting portion of the present invention is disposed in the catheter body, thereby avoiding scratching of the outer wall of the catheter by the metal cutting member, improving the integrity of the instrument and the safety of the operation.
  • the grasping device of the present embodiment includes a support portion 43 in addition to the catheter body 41, the grasping portion 42, and the negative pressure device, and the grasping portion 42 is also different from the first embodiment.
  • the cutting portion 51 of this embodiment is disposed between the distal end of the grasping member 421 and the distal end surface of the catheter body 41.
  • the gripping portion 42 of the present embodiment includes a fixing member 422 , a gripping member 421 , and a limiting member 423 .
  • the fixture 422 is a hollow tubular structure having an axial opening 425 at the distal end, the proximal end being coupled to the control handle.
  • the grasping member 421 is a structure having an arcuate cross section, the proximal end is connected to the fixing member 422, and the distal end is provided with an anchoring structure 424 facing the central axis.
  • the anchoring structure 424 is formed by heat setting bending of the distal end of the gripping member 421, and the end portion may preferably be formed into a pointed anchor structure.
  • a retaining member 423 is further disposed on the gripping member 421.
  • the two ends of the limiting member 423 are connected to the gripping member 421, and a through hole is formed between the limiting member 423 and the gripping member 421, thereby restricting the moving position of the supporting portion 43 passing through the through hole, without being opposed to
  • the gripping member 421 is circumferentially displaced.
  • the gripping members 421 are symmetrically disposed with respect to the central axis, and the number of the gripping members 421 is 2 to 6, which is two in this embodiment. Further, the grasping member 421 and the fixing member 422 of the embodiment are integrally formed and formed. Referring to FIG.
  • the grasping member 421 of the embodiment in the natural state, is in a folded state; when the grasping member 421 is subjected to a radially outward external force, deformation occurs. At this time, the distal ends of the plurality of gripping members 421 are mutually Move away to form a larger opening that can accommodate other objects.
  • an anchoring structure may also be provided on both side edges of the gripping member.
  • the fixture may also be other structures having axial openings, not limited to hollow tubular structures.
  • it may be cylindrical, sheet-like or other shape.
  • the proximal end of the fixing member may be connected to the inner wall of the adjacent catheter, and the support member can support the grasping member as long as the connecting member of the supporting portion can be ensured to pass through the axial opening. Take the piece, and the grasping part can be fixed with respect to the catheter body.
  • the support portion 43 of the present embodiment is disposed inside the grasping member 421 and has an open end at the distal end.
  • the support portion 43 includes a second connecting member 432 and a support member 431.
  • the distal end of the second connecting member 432 is connected to the supporting member 431, and the proximal end is fixed to the control handle.
  • the second connecting member 432 is controlled to move axially by the control handle, the supporting member can be driven to move together.
  • the structure of the support member 431 is substantially the same as that of the grasping member 421, and the number is also the same as that of the grasping member 421, except that the support member 431 is shaped by hot working, has a certain angle with the axial direction, and the plurality of support members 431 are combined to support the support member 431.
  • the distal end of the portion 43 forms an opening having an angle.
  • the support member 431 has an arc shape in cross section, and passes through a through hole formed between the limiting member 423 and the gripping member 421 , that is, the supporting member 431 is located between the gripping member 421 and the limiting member 423 .
  • the curved surface of the support member 431 cooperates with the curved surface of the gripping member 421 to be movable along the gripping member 421.
  • the support member 431 and the grasping member 421 of the embodiment can be made of the same metal material, and the rigidity of the support member 431 is greater than that by the selection of the diameter, the thickness, the cutting texture, the sandblasting and the like. The rigidity of the take-up piece 421.
  • the retaining member may not be provided with a limiting member.
  • the grasping member may be configured to have an inner groove or a cross-sectional concave structure, as long as the supporting member is built. The delivery of the oral device is not displaced relative to the grasping member.
  • the operation process is basically the same as that of the first embodiment, except that the gripping member 421 is made by retracting the support portion 43 when the interatrial space is clamped. Return to the collapsed state, clamp the tissue, and then perform subsequent cutting operations.
  • the grasping member can maintain a good clamping state without applying other objects, and the structure and operation of the ostomy device are appropriately simplified. .

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  • Surgery (AREA)
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Abstract

A neostomy device (100), comprising a gripping means (10), a cutting means (20), and a control handle (30) used for controlling the gripping means (10) and the cutting means (20). The gripping means (10) comprises a catheter body (11), a gripping part (12), and a negative pressure means (13); the negative pressure means (13) is connected to the catheter body (11), and the gripping part (12) is provided in the catheter body (11); the cutting means (20) comprises a cutting member (21), which is provided between a distal end of the gripping part (12) and an end face of a distal end of the catheter body (11); the control handle (30) controls the cutting member (21) to move. The size of a distal end of the neostomy device (100) is small, operations are simple and highly reliable, and an opening left after the neostomy is regular and has a stable shape.

Description

造口器械Ostomy device 技术领域Technical field
本发明涉及介入医疗器械领域,具体涉及一种造口器械。The invention relates to the field of interventional medical devices, in particular to a ostomy device.
背景技术Background technique
心脏的正常收缩和舒张是生物体得以正常活动的保障,当心脏结构或功能发生异常导致心室充盈或射血功能受损时,会产生一组复杂的临床综合征,称为心力衰竭。作为各种心脏病发展的严重阶段,心力衰竭正成为全球最重要的心血管病症。Normal contraction and relaxation of the heart is a guarantee for the normal movement of the organism. When abnormalities in the structure or function of the heart lead to ventricular filling or impaired ejection function, a complex clinical syndrome called heart failure is produced. As a serious stage of various heart disease developments, heart failure is becoming the most important cardiovascular disease in the world.
心力衰竭可分为舒张性心力衰竭和收缩性心力衰竭。舒张性心力衰竭是指在心室收缩功能正常的情况下,心室松弛性和顺应性降低使心室充盈量减少和充盈压升高,从而产生肺循环和体循环淤血综合征。舒张性心力衰竭会导致左心房和肺静脉中的压力升高,妨碍含氧血液的正常流动。现在,治疗舒张性心力衰竭患者的方法很少,临床资料表明,在舒张性心力衰竭患者的房间隔上开一个小孔,形成左向右分流,有利于降低心力衰竭患者的左心房的压力,改善心衰患者的症状。Heart failure can be divided into diastolic heart failure and systolic heart failure. Diastolic heart failure refers to a decrease in ventricular relaxation and a decrease in filling pressure in the case of normal ventricular systolic function, resulting in pulmonary circulation and systemic congestion syndrome. Diastolic heart failure causes an increase in pressure in the left atrium and pulmonary veins, preventing normal flow of oxygenated blood. Nowadays, there are few methods for the treatment of patients with diastolic heart failure. Clinical data indicate that a small hole is formed in the interatrial septum of patients with diastolic heart failure, forming a left-to-right shunt, which is beneficial to reduce the pressure on the left atrium of patients with heart failure. Improve the symptoms of patients with heart failure.
目前一种治疗心衰的方法是先在房间隔组织进行穿刺后,用球囊扩张的方法扩张开口至较大尺寸,但球囊撤出后组织往往会发生回弹致使开口缩小。另一种方法则采用刀片旋切的方式将房间隔组织切除,但此方法形成的开口组织牵连且不规则,形状较难控制,手术操作时间长。At present, a method for treating heart failure is to first expand the opening to a larger size by a balloon expansion method after the atrial septal tissue is puncture, but the tissue tends to rebound after the balloon is withdrawn to cause the opening to shrink. In another method, the atrial septal tissue is excised by means of blade resection, but the open tissue formed by this method is implicated and irregular, the shape is difficult to control, and the operation time is long.
基于此,有必要设计一种操作简便,可靠性高、开口规则且形貌稳定的房间隔造口器械。Based on this, it is necessary to design a septal ostomy device that is easy to operate, highly reliable, and has a regular opening and a stable shape.
发明内容Summary of the invention
本发明要解决的技术问题在于,针对现有技术的缺陷,提供一种操作简便,可靠性高、开口规则且形貌稳定的房间隔造口器械。The technical problem to be solved by the present invention is to provide a room spacing ostomy device which is simple in operation, high in reliability, regular in opening and stable in shape, in view of the defects of the prior art.
本发明提供了一种造口器械,包括抓取装置、切割装置以及用于控制所述抓取装置和所述切割装置的控制手柄,所述抓取装置包括导管体、抓取部以及负压装置,所述负压装置与所述导管体相连,所述抓取部设于所述导管体内;所述切割装置包括切割件,所述切割件设于所述抓取件远端与所述导管体远端端面之间,所述控制手柄控制所述切割件运动。The present invention provides a ostomy apparatus comprising a grasping device, a cutting device, and a control handle for controlling the grasping device and the cutting device, the grasping device comprising a catheter body, a grasping portion, and a negative pressure a device, the negative pressure device is connected to the catheter body, the grasping portion is disposed in the catheter body; the cutting device comprises a cutting member, the cutting member is disposed at the distal end of the grasping member and the Between the distal end faces of the catheter body, the control handle controls movement of the cutting member.
在一实施例中,所述抓取部远端设有抓取件,所述抓取件远端不超过所述导管体远端端面。In an embodiment, the distal end of the grasping portion is provided with a grasping member, and the distal end of the grasping member does not exceed the distal end surface of the catheter body.
在一实施例中,所述抓取部包括至少两个对称设置的抓取件。In an embodiment, the gripping portion comprises at least two symmetrically disposed gripping members.
在一实施例中,所述抓取部远端外侧还设有止挡件,所述止挡件一端与所述抓取件相连,另一端远离所述抓取件朝向所述导管体内壁延伸,所述止挡件与所述抓取件的远端形成范围为0~90度的夹角。In an embodiment, a distal end of the distal end of the grasping portion is further provided with a stopper, one end of the stopper is connected to the grasping member, and the other end is away from the grasping member and extends toward the inner wall of the catheter. The stopper and the distal end of the gripping member form an angle ranging from 0 to 90 degrees.
在一实施例中,所述抓取件自然状态下远端收拢,所述抓取装置还包括支撑部,所述支撑部近端与所述控制手柄连接,所述支撑部设于所述抓取件内侧,且远端呈开口状;所述控制手柄控制所述支撑部朝向远端轴向运动时,所述支撑部远端抵顶所述抓取件内侧,使所述 抓取件远端形成开口。In an embodiment, the grasping member is gathered at a distal end in a natural state, the grasping device further includes a support portion, the proximal end of the support portion is connected to the control handle, and the support portion is disposed on the grasping portion. The inner side of the take-up member has an open shape; and when the control handle controls the axial movement of the support portion toward the distal end, the distal end of the support portion abuts against the inner side of the grasping member, so that the grasping member is far away The end forms an opening.
在一实施例中,所述支撑部包括支撑件以及与所述支撑件近端连接的第二连接件,所述支撑件支撑所述抓取件,所述第二连接件近端与所述控制手柄连接。In an embodiment, the support portion includes a support member and a second connection member coupled to the proximal end of the support member, the support member supports the gripping member, the second connector is proximally connected to the Control handle connection.
在一实施例中,所述抓取件上设有限位件,所述限位件与所述抓取件之间形成通孔,所述支撑件远端穿过所述通孔。In an embodiment, the grasping member is provided with a limiting member, and a through hole is formed between the limiting member and the grasping member, and the distal end of the supporting member passes through the through hole.
在一实施例中,所述抓取件上设有锚定单元。In an embodiment, the gripping member is provided with an anchoring unit.
在一实施例中,所述所述切割装置还包括控制丝,所述控制丝远端与所述切割件连接,所述控制丝近端与所述控制手柄连接,所述控制手柄通过所述控制丝控制所述切割件运动。In one embodiment, the cutting device further includes a control wire, the distal end of the control wire is coupled to the cutting member, the proximal end of the control wire is coupled to the control handle, and the control handle passes the A control wire controls the movement of the cutting member.
本发明提供的造口器械包括抓取装置、切割装置以及用于控制所述抓取装置和切割装置的控制手柄,所述负压装置与所述导管体相连,为所述导管体提供负压,抓取部包括设置于所述导管体内的抓取件以及能够在所述导管体内轴向移动的限制件。相比于现有技术,本发明抓取装置上设置有抓取部,抓取部远端设有抓取件,待切除的组织在负压装置的作用下被吸入导管体后,通过控制近端控制手柄控制限制件的移动,抓取部远端的抓取件将吸入导管体内的人体组织抓紧,接着通过控制手柄收紧切割装置并通电,在控制手柄的作用下即可完成切割,操作简便。切割完成后,抓取部远端的抓取件仍然处于收拢状态并且能将切割下的人体组织夹紧并随导管一并撤出至体外,在后撤造口器械的过程中,切割下的人体组织不会掉落于体内产生风险,同时造口器械通过电切割形成的开口形貌稳定,不会产生回缩。且本发 明的切割装置的切割件设置在抓取件远端与导管体远端端面之间而非环绕在导管体外侧,这样可以大大降低造口器械远端尺寸,能进入更小的血管。The ostomy device provided by the present invention comprises a grasping device, a cutting device and a control handle for controlling the grasping device and the cutting device, the negative pressure device being connected to the catheter body to provide a negative pressure to the catheter body The gripping portion includes a gripping member disposed within the catheter body and a restriction member axially movable within the catheter body. Compared with the prior art, the grasping device of the present invention is provided with a grasping portion, and the distal end of the grasping portion is provided with a grasping member, and the tissue to be cut is sucked into the catheter body by the action of the negative pressure device, and the control is passed through The end control handle controls the movement of the restriction member, and the grasping member at the distal end of the grasping portion grasps the human body tissue sucked into the catheter body, and then tightens the cutting device through the control handle and energizes, and the cutting operation can be completed under the action of the control handle. Simple. After the cutting is completed, the grasping member at the distal end of the grasping portion is still in a folded state and can clamp the human tissue under cutting and withdraw it with the catheter to the outside of the body, in the process of withdrawing the ostomy device, cutting Human tissue does not fall into the body and poses a risk, and the opening formed by the ostomy device by electrical cutting is stable and does not retract. Moreover, the cutting member of the cutting device of the present invention is disposed between the distal end of the grasping member and the distal end surface of the catheter body rather than surrounding the outer side of the catheter body, which greatly reduces the size of the distal end of the ostomy device and allows access to smaller blood vessels.
附图说明DRAWINGS
图1为本发明的造口器械结构示意图;Figure 1 is a schematic view showing the structure of a ostomy device of the present invention;
图2a为本发明第一实施例的造口器械远端内部结构示意图;2a is a schematic view showing the internal structure of the distal end of the ostomy apparatus according to the first embodiment of the present invention;
图2b为图2a的部分结构放大示意图;Figure 2b is an enlarged schematic view showing a portion of the structure of Figure 2a;
图3为本发明第一实施例的造口器械中切割部结构示意图;3 is a schematic structural view of a cutting portion in a ostomy device according to a first embodiment of the present invention;
图4a为本发明第二实施例的造口器械远端内部结构示意图;4a is a schematic view showing the internal structure of a distal end of a ostomy apparatus according to a second embodiment of the present invention;
图4b为图4a的部分结构放大示意图;Figure 4b is an enlarged schematic view showing a portion of the structure of Figure 4a;
图5为本发明第二实施例的造口器械中抓取件简化结构示意图;Figure 5 is a schematic view showing a simplified structure of a grasping member in a ostomy apparatus according to a second embodiment of the present invention;
图6为本发明第二实施例的造口器械的抓取部横截面结构示意图。Fig. 6 is a schematic cross-sectional view showing the grasping portion of the ostomy apparatus according to the second embodiment of the present invention.
具体实施方式Detailed ways
为了对本发明的技术特征、目的和效果有更加清楚的理解,现对照附图详细说明本发明的具体实施方式。For a better understanding of the technical features, objects and effects of the present invention, the embodiments of the present invention are described in detail with reference to the accompanying drawings.
为了更加清楚地描述本发明的结构,采用“远端”、“近端”作为方位词,该方位词为介入医疗器械领域惯用术语,其中“远端”表示手术过程中远离操作者的一端,“近端”表示手术过程中靠近操作者的一端。所述“轴向”,指医疗器械远端中心和近端中心连线的方向, 该方向的连线为“中心轴向轴线”;所述“径向”,指垂直于上述轴向的方向。In order to more clearly describe the structure of the present invention, "distal" and "near end" are used as the orientation words, which are the conventional terms in the field of interventional medical devices, wherein "distal" means the end away from the operator during the operation, "Proximal" means the end that is close to the operator during the procedure. The "axial direction" refers to the direction in which the distal end of the medical device is connected to the center of the proximal end, and the connection in the direction is the "central axial axis"; the "radial" refers to the direction perpendicular to the axial direction. .
第一实施例First embodiment
参见图1至图2b,本实施例提供的造口器械100包括切割装置20、抓取装置10、及控制手柄30。切割装置20包括切割部21以及用于给切割部21供电的高频电源22,抓取装置10包括导管体11、抓取部12以及负压源13。切割部21设置于导管体11内部,用于切割被造口器械100吸入导管体11内的人体房间隔组织。负压源13与导管体11连通,用于使导管体11内形成负压以吸附人体房间隔组织,抓取部12设置在导管体11的管腔远端,靠近导管体11远端开口,用于夹持被造口器械100吸入导管体11管腔内的人体房间隔组织。控制手柄30设置于导管体11近端并与导管体11近端相连接,控制手柄30用于驱动造口器械100的各部件运动。Referring to FIGS. 1 to 2b, the ostomy apparatus 100 of the present embodiment includes a cutting device 20, a grasping device 10, and a control handle 30. The cutting device 20 includes a cutting portion 21 and a high frequency power source 22 for supplying power to the cutting portion 21, and the gripping device 10 includes a catheter body 11, a gripping portion 12, and a negative pressure source 13. The cutting portion 21 is provided inside the catheter body 11 for cutting the body compartment spacer tissue in the catheter body 11 by the ostomy appliance 100. The negative pressure source 13 is in communication with the catheter body 11 for forming a negative pressure in the catheter body 11 to adsorb the human body compartment tissue. The grasping portion 12 is disposed at the distal end of the lumen of the catheter body 11 near the distal end of the catheter body 11, The body compartment spacer for inhaling the ostomy device 100 into the lumen of the catheter body 11. The control handle 30 is disposed at the proximal end of the catheter body 11 and is coupled to the proximal end of the catheter body 11, and the control handle 30 is used to drive the movement of the various components of the ostomy appliance 100.
进一步地,请一并参阅图1至图2b,导管体11包括两部分,导管体11的近端部分设置有多根加强筋110,从而形成多个互不相通的细管腔115,以增加导管体11近端的硬度,提高导管体11的抗折弯性能。导管体11的远端部分中空,形成唯一的主管腔111。本实施例中,可以通过成型设备将导管体11成型为一体多腔的结构,导管体11的材料可为尼龙、聚四氟乙烯或PEBAX等。加强筋110为等厚的薄片状,沿导管11轴线对称分布,数量可为2~6个,优选为2~4个。导管体11内还设有一与其同轴的管腔116,管腔116外侧与加强筋 110相连。在实际使用时,由于导管体11需要穿刺后介入人体内,为避免穿刺点扩张,同时保证导管体11内径尺寸满足需求,因此需减小导管体11壁厚,当导管体11壁厚减小后,导管体11会变得较为柔软,这里设置加强筋110能够有效增加导管体11的强度以及抗弯折性能。Further, referring to FIG. 1 to FIG. 2b, the catheter body 11 comprises two parts, and the proximal end portion of the catheter body 11 is provided with a plurality of reinforcing ribs 110, thereby forming a plurality of thin lumens 115 which are not connected to each other to increase The hardness of the proximal end of the catheter body 11 improves the bending resistance of the catheter body 11. The distal end portion of the catheter body 11 is hollow to form a single main lumen 111. In this embodiment, the catheter body 11 can be formed into a multi-cavity structure by a molding device, and the material of the catheter body 11 can be nylon, polytetrafluoroethylene or PEBAX. The ribs 110 are in the form of sheets of equal thickness and are symmetrically distributed along the axis of the conduit 11, and the number may be 2 to 6, preferably 2 to 4. The catheter body 11 is further provided with a lumen 116 coaxial therewith, and the outside of the lumen 116 is connected to the rib 110. In actual use, since the catheter body 11 needs to be inserted into the human body after puncture, in order to avoid the expansion of the puncture point and ensure that the inner diameter of the catheter body 11 meets the demand, it is necessary to reduce the wall thickness of the catheter body 11 when the wall thickness of the catheter body 11 is reduced. After that, the catheter body 11 becomes relatively soft, and the provision of the reinforcing ribs 110 here can effectively increase the strength and bending resistance of the catheter body 11.
可以理解的是,在其它实施例中,当导管体11材料硬度较高时,也可以不设置加强筋110,即导管体11为一体设计,只要能够在保证导管体11壁厚较小的同时使导管体11具有一定的抗折弯性能即可。It can be understood that, in other embodiments, when the material strength of the catheter body 11 is high, the reinforcing ribs 110 may not be provided, that is, the catheter body 11 is integrally designed as long as the wall thickness of the catheter body 11 is small. The catheter body 11 can have a certain bending resistance.
在其它实施例中,还可以通过在导管体11内嵌设镍钛丝的方式来增强其抗折弯性能,或者在导管体11的近端部分内套设支撑管,亦可增大近端部分的硬度,达到良好抗折弯性能的目的。In other embodiments, it is also possible to enhance the bending resistance by embedding a nickel-titanium wire in the catheter body 11, or to sleeve the support tube in the proximal end portion of the catheter body 11, or to increase the proximal end. Part of the hardness, the purpose of achieving good bending resistance.
再次参阅图2a和图2b,抓取部12包含抓取件121、限制件123、固定件122、第一连接件126及管体125。抓取件121位于抓取部12远端,与导管体11同轴设置,抓取件121的远端端面退缩于导管体11的远端端面内。限制件123同轴地套设在抓取件121上,用于控制抓取件121远端的开合。第一连接件126连接于限制件123的近端,第一连接件126穿过管腔116后近端与控制手柄30相连,用于控制限制件123在轴向方向上的移动。管体125设置于导管体11内壁,用于固定抓取件121。Referring again to FIGS. 2a and 2b, the gripping portion 12 includes a gripping member 121, a restricting member 123, a fixing member 122, a first connecting member 126, and a tubular body 125. The grasping member 121 is located at the distal end of the grasping portion 12, and is disposed coaxially with the catheter body 11, and the distal end surface of the grasping member 121 is retracted into the distal end surface of the catheter body 11. The restricting member 123 is coaxially sleeved on the gripping member 121 for controlling the opening and closing of the distal end of the gripping member 121. The first connecting member 126 is connected to the proximal end of the restricting member 123. The first connecting member 126 passes through the lumen 116 and is connected to the control handle 30 at the proximal end for controlling the movement of the restricting member 123 in the axial direction. The tubular body 125 is disposed on the inner wall of the catheter body 11 for fixing the grasping member 121.
抓取件121近端连接有多个固定件122,远端设有多个夹爪1211,多个固定件122与多个夹爪1211通过轴杆1212连接。多个夹爪1211在自然状态下从近端至远端相互分离,在外力的束缚下,多个夹爪 1211能够相互聚拢。其中任意两个夹爪1211之间的直线距离小于所述导管体11的内径长度,从而保证多个夹爪1211在自然状态下能够容纳于导管体11内。多个固定件122设置于抓取部12的近端,沿圆周方向向外延伸,固定件122近端为片状结构,固定件通过近端的片状结构与管体125固定连接,使抓取件121在操作过程中不发生相对于导管体11的移动。其中固定件122的数量为2~5个,本实施例优选为3个,3个固定件122均匀分布在抓取件121沿轴线的圆周上,可以理解的是,在其他实施例中,固定件122也可以不均匀分布。A plurality of fixing members 122 are connected to the proximal end of the grasping member 121, and a plurality of clamping jaws 1211 are disposed at the distal end. The plurality of fixing members 122 and the plurality of clamping jaws 1211 are connected by the shaft 1212. The plurality of jaws 1211 are separated from each other from the proximal end to the distal end in a natural state, and the plurality of jaws 1211 can be gathered from each other under the constraint of an external force. The linear distance between any two of the jaws 1211 is smaller than the inner diameter of the catheter body 11, thereby ensuring that the plurality of jaws 1211 can be accommodated in the catheter body 11 in a natural state. A plurality of fixing members 122 are disposed at the proximal end of the grasping portion 12 and extend outward in the circumferential direction. The proximal end of the fixing member 122 is a sheet-like structure, and the fixing member is fixedly connected with the tubular body 125 through the proximal-shaped sheet-like structure, so as to grasp The pickup 121 does not move relative to the catheter body 11 during operation. The number of the fixing members 122 is 2-5, and the present embodiment is preferably 3. The three fixing members 122 are evenly distributed on the circumference of the grasping member 121 along the axis. It can be understood that, in other embodiments, the fixing is fixed. The pieces 122 can also be unevenly distributed.
由于本发明中,抓取部12通过固定件122固定于导管体11内壁,当造口器械100在人体内移动时,抓取件121的远端不会因为导管体11弯曲而伸出至导管体11外,避免对人体组织造成划伤、割伤、刺破。In the present invention, the grasping portion 12 is fixed to the inner wall of the catheter body 11 by the fixing member 122. When the ostomy device 100 moves in the human body, the distal end of the grasping member 121 does not protrude to the catheter due to the bending of the catheter body 11. Outside the body 11, avoid scratching, cutting, or puncturing the human tissue.
可以理解的是,在其它实施例中,固定件122也可以设置于抓取部12的其他位置,固定件122的形状也可以为其它形状,例如柱状、片状、倒钩状等,只需要保证固定件122能与管体125固定贴合即可。It can be understood that in other embodiments, the fixing member 122 can also be disposed at other positions of the grasping portion 12, and the shape of the fixing member 122 can also be other shapes, such as a column shape, a sheet shape, a barb shape, etc., only need It is ensured that the fixing member 122 can be fixedly attached to the tubular body 125.
本实施例中,抓取件121相对于中心轴线对称设置,的且数量可选为2~6个,本实施例为2个。抓取件121的夹爪1211的数量为4个,4个夹爪1211从近端至远端逐渐分离。夹爪1211上设置有多个锚定单元,锚定单元可以是凸棱、锯齿等,本实施例中,锚定单元为锯齿。锯齿设置于夹爪1211内侧,可对称分布或错落分布,锯齿的数量为1~10个,优选的为4~8个,可均匀排列或不等间距排列。多个锯齿排列在一起时,其整体形状可以三角波、方波、正弦波或任意 波形,或者以上两种或多种波形的组合。在夹爪1211上设置锯齿可以保证当对人体组织进行夹持时,锯齿能够与人体组织相钩,使夹持更加牢固。In this embodiment, the gripping members 121 are symmetrically disposed with respect to the central axis, and the number of the gripping members 121 may be 2-6, and the number of the embodiment is 2. The number of the jaws 1211 of the grasping member 121 is four, and the four jaws 1211 are gradually separated from the proximal end to the distal end. The clamping claw 1211 is provided with a plurality of anchoring units, and the anchoring unit may be a rib, a serration or the like. In this embodiment, the anchoring unit is a sawtooth. The serrations are disposed on the inner side of the clamping jaws 1211 and can be symmetrically distributed or staggered. The number of serrations is 1 to 10, preferably 4 to 8, and can be evenly arranged or unequally arranged. When a plurality of saw teeth are arranged together, the overall shape may be a triangular wave, a square wave, a sine wave or an arbitrary waveform, or a combination of two or more of the above. The provision of serrations on the jaws 1211 ensures that when the body tissue is clamped, the serrations can be hooked to the body tissue to make the grip more secure.
可以理解的是,在其它实施例中,夹爪1211上的锚定单元也可以省略不要。It will be appreciated that in other embodiments, the anchoring unit on the jaws 1211 may also omit.
还可以理解的是,在其它实施例中,也可以采用其他结构来代替夹爪1211,例如,在抓取件121远端设置一个抓取网、夹板等。It will also be appreciated that in other embodiments, other configurations may be employed in place of the jaws 1211, for example, a grasping net, splint, etc., disposed at the distal end of the grasping member 121.
再次参阅图2a和图2b,本实施例中,限制件123整体呈管状,限制件123的管壁一周沿长度方向开设有多个槽孔1231,槽孔1231的数量与固定件122的数量相同。限制件123套设于抓取件121,单个固定件122从限制件123的单个槽孔1231中伸出,抓取件121从限制件123的远端开口伸出。向远端移动限制件123,多个夹爪1211被束缚并拢;再向近端移动限制件123,限制件123对夹持部1213束缚作用逐渐消失,夹爪1211相互分离,从而抓取件121处于能够容纳人体组织的状态。限制件123长度范围为3~8mm,优选为4~6mm,本实施例为5mm。Referring to FIG. 2a and FIG. 2b again, in the embodiment, the restricting member 123 has a tubular shape as a whole, and the tube wall of the restricting member 123 is provided with a plurality of slots 1231 in the longitudinal direction. The number of the slots 1231 is the same as the number of the fixing members 122. . The restricting member 123 is sleeved on the gripping member 121, and a single fixing member 122 protrudes from a single slot 1231 of the restricting member 123, and the gripping member 121 protrudes from the distal opening of the restricting member 123. Moving the restricting member 123 to the distal end, the plurality of jaws 1211 are restrained and closed; and the restricting member 123 is moved to the proximal end, the restraining action of the restricting member 123 on the clamping portion 1213 gradually disappears, and the jaws 1211 are separated from each other, thereby grasping the member 121. It is in a state capable of accommodating human tissue. The length of the restricting member 123 ranges from 3 to 8 mm, preferably from 4 to 6 mm, and is 5 mm in this embodiment.
管体125设置于导管体11远端内壁,管体125远端端部与导管体11远端端部相平齐或略缩于导管体11远端端部。管体125用于固定抓取件121,管体125外壁与导管体11内壁可以通过粘接的方式固定,抓取件121的固定件122可以通过焊接或粘接的方式固定于管体125内壁,从而保证在手术过程中,抓取件121不会产生轴向移动,防止抓取件121远端从导管体11远端露出而刮伤人体组织。The tubular body 125 is disposed on the inner wall of the distal end of the catheter body 11, and the distal end of the tubular body 125 is flush with the distal end of the catheter body 11 or is slightly contracted to the distal end of the catheter body 11. The tube body 125 is used for fixing the gripping member 121. The outer wall of the tube body 125 and the inner wall of the duct body 11 can be fixed by bonding. The fixing member 122 of the gripping member 121 can be fixed to the inner wall of the tube body 125 by welding or bonding. Therefore, it is ensured that the grasping member 121 does not generate axial movement during the operation, and the distal end of the grasping member 121 is prevented from being exposed from the distal end of the catheter body 11 to scratch the human tissue.
可以理解的是,在其它实施例中,也可以不设置管体125,可以在固定件122套设高分子材料,在通过热熔、或者胶黏等方式与导管体11内壁直接固定连接。It can be understood that in other embodiments, the tube body 125 may not be disposed, and the polymer material may be sleeved on the fixing member 122, and directly connected to the inner wall of the catheter body 11 by heat fusion or adhesive bonding.
进一步的,本实施例中,管体125的材料可选用镍钛合金、不锈钢及钴铬合金等金属材料,可通过机械线切割的加工,通过金属环冷压成型,或通过选择性激光烧结的3D打印技术获得。管体125的主体形状可为圆形、椭圆或组合的异形。Further, in this embodiment, the material of the tube body 125 may be selected from a metal material such as a nickel-titanium alloy, a stainless steel or a cobalt-chromium alloy, which can be processed by mechanical wire cutting, cold-pressed by a metal ring, or by selective laser sintering. 3D printing technology is available. The body shape of the tubular body 125 may be a circular, elliptical or combined profile.
第一连接件126远端与限制件123近端固定连接,第一连接件126近端与控制手柄30相连,通过控制手柄30控制第一连接件126进行轴向运动,从而控制限制件123进行轴向运动。The distal end of the first connecting member 126 is fixedly connected to the proximal end of the limiting member 123. The proximal end of the first connecting member 126 is connected to the control handle 30, and the first connecting member 126 is controlled to move axially by the control handle 30, thereby controlling the limiting member 123. Axial movement.
可以理解的是,在其它实施例中,第一连接件126也可以省略,此时限制件123近端可以直接与控制手柄30相连。It can be understood that in other embodiments, the first connecting member 126 can also be omitted. At this time, the proximal end of the restricting member 123 can be directly connected to the control handle 30.
再次参见图2a和图2b,本实施例的造口器械靠近抓取件121远端部分外侧还设有止挡件124。止挡件124一端与抓取件121相连,另一端远离抓取件121朝向导管体11内壁延伸。因此,在止挡件124与抓取件121远端之间形成了夹角,夹角的角度范围为0~90°。Referring again to Figures 2a and 2b, the ostomy apparatus of the present embodiment is further provided with a stop member 124 adjacent the distal end portion of the grasping member 121. One end of the stopper 124 is connected to the gripping member 121, and the other end extends away from the gripping member 121 toward the inner wall of the catheter body 11. Therefore, an angle is formed between the stopper 124 and the distal end of the gripping member 121, and the angle of the included angle ranges from 0 to 90°.
一并参见图2a至图3,本实施例的切割部21包括切割件212和控制丝211。切割件212架设于止挡件124与抓取件121形成的夹角结构上。切割件212为大致环形结构,环形结构垂直于导管体11的轴向。控制丝211穿过导管体11内壁设的管壁腔(图未标示出)之后远端与切割件212相连,近端与控制手柄30相连。控制丝211可在控制手柄30的控制下向近端移动,同时带动切割件212先发生相对 于导管体11的径向运动,切割件212被部分收进管壁腔内,从而收紧穿过切割件212的物体;切割件212被部分收进管壁腔内后,控制丝211进一步向近端移动,带动切割件212被收进管壁腔的部分轴向运动,进一步收紧穿过切割件212的物体。本实施例的切割部21由导电性能良好的金属材料制成。Referring to Figures 2a to 3 together, the cutting portion 21 of the present embodiment includes a cutting member 212 and a control wire 211. The cutting member 212 is mounted on the angled structure formed by the stopper 124 and the gripping member 121. The cutting member 212 has a substantially annular structure that is perpendicular to the axial direction of the catheter body 11. The control wire 211 passes through a wall cavity (not shown) provided on the inner wall of the catheter body 11 and is connected to the cutting member 212 at the distal end and to the control handle 30 at the proximal end. The control wire 211 can be moved proximally under the control of the control handle 30, while the cutting member 212 is first moved radially relative to the catheter body 11, and the cutting member 212 is partially received into the lumen wall cavity, thereby tightening through The object of the cutting member 212; after the cutting member 212 is partially received into the wall of the tube wall, the control wire 211 is further moved to the proximal end to drive the cutting member 212 to be axially moved into the wall portion of the tube wall, and further tightened through the cutting portion. The object of piece 212. The cutting portion 21 of the present embodiment is made of a metal material having good electrical conductivity.
可以理解的是,在其它实施例中,也可以不设置止挡件,此时,切割部的切割件设于抓取件的远端与导管体的端面之间,切割件贴于导管体内壁且依靠自身材料的刚度不随造口器械在人体管腔内的输送而发生位置偏移。相对于将切割件架设在抓取件远端外侧的结构而言,将切割件设于抓取件的远端与导管体的端面之间可以保证切割件收紧时不会将抓取件也一并束缚,切割可靠度更高。It can be understood that, in other embodiments, the stopper may not be provided. At this time, the cutting member of the cutting portion is disposed between the distal end of the grasping member and the end surface of the catheter body, and the cutting member is attached to the inner wall of the catheter. And the stiffness of the material depends on the positional displacement of the ostomy device in the lumen of the human body. Relative to the structure for arranging the cutting member on the outer side of the distal end of the grasping member, the cutting member is disposed between the distal end of the grasping member and the end surface of the catheter body to ensure that the grasping member is not grasped when the cutting member is tightened. Together, the cutting reliability is higher.
再次参阅图1,本发明实施例中,抓取装置10和切割装置20还分别包括负压装置13及高频电源22。负压装置13通过第一连接管301与控制手柄30连接,高频电源22通过第二连接管302与控制手柄30连接。负压装置13用于将人体组织吸附至导管体11内,高频电源22用于对切割部21通高频电流,并与患者体表的中性电极板(图中未示出)形成回路,从而切除由导管体11吸住的人体组织。高频电源22工作频率为300kHz~5MHz,优选的,频率范围为400kHz~1000kHz,高频电源22的输出功率为0~300w,优选的,功率范围为50~100w。Referring again to FIG. 1, in the embodiment of the present invention, the grasping device 10 and the cutting device 20 further include a negative pressure device 13 and a high frequency power source 22, respectively. The vacuum device 13 is connected to the control handle 30 via a first connecting pipe 301, and the high frequency power source 22 is connected to the control handle 30 via a second connecting pipe 302. The negative pressure device 13 is for adsorbing human tissue into the catheter body 11, and the high-frequency power source 22 is configured to pass a high-frequency current to the cutting portion 21 and form a circuit with a neutral electrode plate (not shown) of the patient's body surface. Thereby, the human tissue sucked by the catheter body 11 is cut. The high frequency power source 22 has an operating frequency of 300 kHz to 5 MHz, preferably, the frequency range is 400 kHz to 1000 kHz, and the output power of the high frequency power source 22 is 0 to 300 w. Preferably, the power range is 50 to 100 w.
下面对造口器械100进行房间隔造口时的工作过程进行进一步的描述。The working process of the ostomy device 100 during the atrial septum is further described below.
利用本实施例的造口器械100进行房间隔造口时,导管体11经皮 穿刺进入人体,到达心脏,导管体11远端端面抵于房间隔组织上,驱动负压装置13,在负压作用下部分人体组织被吸入导管体11内。进一步操作控制手柄30使第一连接件126带动限制件123向远端面移动,夹爪1211逐渐沿导管体11的径向方向夹紧。夹爪1211上的锯齿能够反向勾住房间隔组织,使抓取件121将人体组织牢固夹持。进一步通过控制手柄30向近端拉动控制丝211,从而使切割部21逐渐变形,在管壁腔内壁的作用下,切割部21被逐渐挤压束缚成直线状,并逐渐收容于管壁腔中。在切割部21不断进入管壁腔时,被吸入导管体11的人体房间隔组织也将被切割部21套住,在切割部21不断收紧的过程中,高频电源22可在临床医生的控制下,向切割部21递送高频电流,并与患者体表的中性电极板(未示出)形成回路,从而切除由导管体11吸住的人体房间隔组织。切除后的人体组织依然被抓取件121夹持,同时由于限制件123的限位作用,抓取件121夹持人体组织十分牢固,不会因为造口器械100的移动、振动等使已切割的人体组织掉落,从而提高了手术的安全性。另外,本发明的切割部的切割件设置在导管体内,避免了金属切割件对导管体外壁的刮擦,提高了器械的完整性和手术的安全性。When the atrial septum is made by the ostomy apparatus 100 of the embodiment, the catheter body 11 is percutaneously punctured into the human body and reaches the heart. The distal end surface of the catheter body 11 abuts against the interatrial septum, and drives the negative pressure device 13 at a negative pressure. Part of the human tissue is sucked into the catheter body 11 under the action. The control handle 30 is further operated to cause the first link member 126 to move the restricting member 123 to the distal end surface, and the jaws 1211 are gradually clamped in the radial direction of the catheter body 11. The serrations on the jaws 1211 are capable of reversing the housing spacers so that the gripping members 121 hold the body tissue securely. Further, the control wire 211 is pulled toward the proximal end by the control handle 30, so that the cutting portion 21 is gradually deformed, and under the action of the inner wall of the tube wall cavity, the cutting portion 21 is gradually squeezed and bound into a straight line, and is gradually accommodated in the tube wall cavity. . When the cutting portion 21 continuously enters the wall cavity, the human body spacer tissue sucked into the catheter body 11 will also be trapped by the cutting portion 21, and during the process of continuously tightening the cutting portion 21, the high frequency power source 22 can be used by the clinician. Under control, a high-frequency current is delivered to the cutting portion 21, and a circuit is formed with a neutral electrode plate (not shown) of the patient's body surface, thereby excising the body atrial space tissue sucked by the catheter body 11. The removed human body tissue is still clamped by the grasping member 121, and at the same time, due to the limiting action of the restricting member 123, the grasping member 121 is firmly clamped to the human body and is not cut by the movement, vibration, etc. of the ostomy device 100. The body tissue is dropped, which improves the safety of the operation. In addition, the cutting member of the cutting portion of the present invention is disposed in the catheter body, thereby avoiding scratching of the outer wall of the catheter by the metal cutting member, improving the integrity of the instrument and the safety of the operation.
第二实施例Second embodiment
本实施例与第一实施例的不同之处在于抓取装置。本实施例的抓取装置除包括导管体41、抓取部42和负压装置外,还包括支撑部43,且抓取部42也与第一实施例不同。本实施例的切割部51设于抓取件 421远端与导管体41远端端面之间。This embodiment differs from the first embodiment in the gripping device. The grasping device of the present embodiment includes a support portion 43 in addition to the catheter body 41, the grasping portion 42, and the negative pressure device, and the grasping portion 42 is also different from the first embodiment. The cutting portion 51 of this embodiment is disposed between the distal end of the grasping member 421 and the distal end surface of the catheter body 41.
参见图4a至图5,本实施例的抓取部42包括固定件422、抓取件421以及限位件423。固定件422为远端具有轴向开口425的中空管状结构,近端与控制手柄相连。抓取件421为横截面为弧形的结构,近端与固定件422相连,远端设有朝向中心轴线的锚定结构424。锚定结构424为抓取件421远端端部经热定型弯折加工形成,端部可优选制成尖的锚刺结构。抓取件421上还设有限位件423。限位件423两端与抓取件421相连,且在限位件423与抓取件421之间形成通孔,从而限制从通孔中穿过的支撑部43的移动位置,不会相对于抓取件421发生周向移位。抓取件421相对于中心轴线对称设置,且数量可选为2~6个,本实施例为2个。进一步地,本实施例的抓取件421与固定件422为一体加工成型。参见图5,自然状态下,本实施例的抓取件421处于收拢状态;当抓取件421受到径向向外的外力时会发生形变,此时,多个抓取件421的远端相互远离,形成能容纳其它物体的较大开口。Referring to FIGS. 4 a to 5 , the gripping portion 42 of the present embodiment includes a fixing member 422 , a gripping member 421 , and a limiting member 423 . The fixture 422 is a hollow tubular structure having an axial opening 425 at the distal end, the proximal end being coupled to the control handle. The grasping member 421 is a structure having an arcuate cross section, the proximal end is connected to the fixing member 422, and the distal end is provided with an anchoring structure 424 facing the central axis. The anchoring structure 424 is formed by heat setting bending of the distal end of the gripping member 421, and the end portion may preferably be formed into a pointed anchor structure. A retaining member 423 is further disposed on the gripping member 421. The two ends of the limiting member 423 are connected to the gripping member 421, and a through hole is formed between the limiting member 423 and the gripping member 421, thereby restricting the moving position of the supporting portion 43 passing through the through hole, without being opposed to The gripping member 421 is circumferentially displaced. The gripping members 421 are symmetrically disposed with respect to the central axis, and the number of the gripping members 421 is 2 to 6, which is two in this embodiment. Further, the grasping member 421 and the fixing member 422 of the embodiment are integrally formed and formed. Referring to FIG. 5, in the natural state, the grasping member 421 of the embodiment is in a folded state; when the grasping member 421 is subjected to a radially outward external force, deformation occurs. At this time, the distal ends of the plurality of gripping members 421 are mutually Move away to form a larger opening that can accommodate other objects.
在其它实施例中,也可以在抓取件的两侧边缘均设置锚定结构。In other embodiments, an anchoring structure may also be provided on both side edges of the gripping member.
在其它实施例中,固定件也可以是具有轴向开口的其它结构,不限于中空管状结构。例如,可以是柱形、片状或其它形状,此时,可以将固定件的近端与就近的导管体内壁相连,只要能保证支撑部的连接件穿过轴向开口,支撑件能支撑抓取件,且抓取部能相对导管体固定即可。In other embodiments, the fixture may also be other structures having axial openings, not limited to hollow tubular structures. For example, it may be cylindrical, sheet-like or other shape. In this case, the proximal end of the fixing member may be connected to the inner wall of the adjacent catheter, and the support member can support the grasping member as long as the connecting member of the supporting portion can be ensured to pass through the axial opening. Take the piece, and the grasping part can be fixed with respect to the catheter body.
同时参阅图4a、图4b和图6,本实施例的支撑部43设于抓取件 421内侧且远端呈开口状。支撑部43包括第二连接件432和支撑件431。第二连接件432远端与支撑件431相连,近端固定于控制手柄上,通过控制手柄控制第二连接件432轴向移动时,可带动支撑件一并移动。支撑件431结构基本与抓取件421相同,且数量亦与抓取件421一致,不同之处在于,支撑件431经热加工定型,与轴向具有一定角度,多个支撑件431组合使支撑部43远端形成具有一定角度的开口。如图6所示,支撑件431横截面为弧形,穿过限位件423与抓取件421之间形成的通孔,即支撑件431位于抓取件421与限位件423之间。支撑件431的弧面与抓取件421的弧面相配合,可以沿着抓取件421移动。4a, 4b, and 6, the support portion 43 of the present embodiment is disposed inside the grasping member 421 and has an open end at the distal end. The support portion 43 includes a second connecting member 432 and a support member 431. The distal end of the second connecting member 432 is connected to the supporting member 431, and the proximal end is fixed to the control handle. When the second connecting member 432 is controlled to move axially by the control handle, the supporting member can be driven to move together. The structure of the support member 431 is substantially the same as that of the grasping member 421, and the number is also the same as that of the grasping member 421, except that the support member 431 is shaped by hot working, has a certain angle with the axial direction, and the plurality of support members 431 are combined to support the support member 431. The distal end of the portion 43 forms an opening having an angle. As shown in FIG. 6 , the support member 431 has an arc shape in cross section, and passes through a through hole formed between the limiting member 423 and the gripping member 421 , that is, the supporting member 431 is located between the gripping member 421 and the limiting member 423 . The curved surface of the support member 431 cooperates with the curved surface of the gripping member 421 to be movable along the gripping member 421.
本实施例中,支撑件431远端穿过限位件423与抓取件421之间形成的通孔后,对抓取件421施加径向向外的力,使多个抓取件421处于张开的状态;当支撑件431向近端移动时,相当于撤消支撑件431对抓取件421的施力,抓取件421恢复至收拢的状态。本实施例的支撑件431与抓取件421可采用相同的金属材料制成,通过在直径、厚度上的选择,以及切割纹理、喷砂抛光等工艺处理的不同保证支撑件431的刚度大于抓取件421的刚度。In this embodiment, after the distal end of the support member 431 passes through the through hole formed between the limiting member 423 and the grasping member 421, a radially outward force is applied to the grasping member 421, so that the plurality of grasping members 421 are at When the support member 431 is moved to the proximal end, it is equivalent to undoing the force applied by the support member 431 to the grasping member 421, and the grasping member 421 is restored to the collapsed state. The support member 431 and the grasping member 421 of the embodiment can be made of the same metal material, and the rigidity of the support member 431 is greater than that by the selection of the diameter, the thickness, the cutting texture, the sandblasting and the like. The rigidity of the take-up piece 421.
可以理解的是,在其他实施例中,抓取件上也可不设置限位件,此时,可以将抓取件设置成具有内槽或者横截面为凹形的结构,只要保证支撑件在造口器械的输送过程中不相对于抓取件发生移位即可。It can be understood that, in other embodiments, the retaining member may not be provided with a limiting member. In this case, the grasping member may be configured to have an inner groove or a cross-sectional concave structure, as long as the supporting member is built. The delivery of the oral device is not displaced relative to the grasping member.
在使用本实施例的造口器械进行房间隔造口时,操作过程基本与第一实施例相同,不同之处在于,夹持房间隔组织时,通过后撤支撑 部43,使抓取件421恢复至收拢状态,夹紧组织,再进行后续切割操作。相较于第一实施例,本实施例的造口器械在夹紧组织后,抓取件不需要其它物件施力即可保持较好的夹紧状态,适当简化了造口器械的结构和操作。When the atrial septum is used for the atrial septum using the ostomy apparatus of the present embodiment, the operation process is basically the same as that of the first embodiment, except that the gripping member 421 is made by retracting the support portion 43 when the interatrial space is clamped. Return to the collapsed state, clamp the tissue, and then perform subsequent cutting operations. Compared with the first embodiment, after the ostomy device of the embodiment clamps the tissue, the grasping member can maintain a good clamping state without applying other objects, and the structure and operation of the ostomy device are appropriately simplified. .
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。The technical features of the above-described embodiments may be arbitrarily combined. For the sake of brevity of description, all possible combinations of the technical features in the above embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be considered as the scope of this manual.
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。The above-described embodiments are merely illustrative of several embodiments of the present invention, and the description thereof is more specific and detailed, but is not to be construed as limiting the scope of the invention. It should be noted that a number of variations and modifications may be made by those skilled in the art without departing from the spirit and scope of the invention. Therefore, the scope of the invention should be determined by the appended claims.

Claims (9)

  1. 一种造口器械,包括抓取装置、切割装置以及用于控制所述抓取装置和所述切割装置的控制手柄,其特征在于,所述抓取装置包括导管体、抓取部以及负压装置,所述负压装置与所述导管体相连,所述抓取部设于所述导管体内;所述切割装置包括切割件,所述切割件设于所述抓取件远端与所述导管体远端端面之间,所述控制手柄控制所述切割件运动。A ostomy device comprising a grasping device, a cutting device, and a control handle for controlling the grasping device and the cutting device, wherein the grasping device comprises a catheter body, a grasping portion, and a negative pressure a device, the negative pressure device is connected to the catheter body, the grasping portion is disposed in the catheter body; the cutting device comprises a cutting member, the cutting member is disposed at the distal end of the grasping member and the Between the distal end faces of the catheter body, the control handle controls movement of the cutting member.
  2. 根据权利要求1所述的造口器械,其特征在于,所述抓取部远端设有抓取件,所述抓取件远端不超过所述导管体远端端面。The ostomy apparatus according to claim 1, wherein the distal end of the grasping portion is provided with a grasping member, and the distal end of the grasping member does not exceed the distal end surface of the catheter body.
  3. 根据权利要求2所述的造口器械,其特征在于,所述抓取部包括至少两个对称设置的抓取件。The ostomy apparatus according to claim 2, wherein the gripping portion comprises at least two symmetrically disposed gripping members.
  4. 根据权利要求3所述的造口器械,其特征在于,所述抓取部远端外侧还设有止挡件,所述止挡件一端与所述抓取件相连,另一端远离所述抓取件朝向所述导管体内壁延伸,所述止挡件与所述抓取件的远端形成范围为0~90度的夹角。The ostomy apparatus according to claim 3, wherein a distal end of the distal end of the grasping portion is further provided with a stopper, and one end of the stopper is connected to the grasping member, and the other end is away from the grasping member. The pick-up extends toward the inner wall of the catheter, and the stop forms an angle with the distal end of the grasping member ranging from 0 to 90 degrees.
  5. 根据权利要求3所述的造口器械,其特征在于,所述抓取件自然状态下远端收拢,所述抓取装置还包括支撑部,所述支撑部近端与所述控制手柄连接,所述支撑部设于所述抓取件内侧,且远端呈开口状;所述控制手柄控制所述支撑部朝向远端轴向运动时,所述支撑部远端抵顶所述抓取件内侧,使所述抓取件远端形成开口。The ostomy apparatus according to claim 3, wherein the grasping member is gathered at a distal end in a natural state, and the grasping device further includes a support portion, and the proximal end of the support portion is connected to the control handle. The support portion is disposed on the inner side of the gripping member, and the distal end is open; when the control handle controls the axial movement of the support portion toward the distal end, the distal end of the support portion abuts the grasping member On the inner side, the distal end of the gripping member is formed into an opening.
  6. 根据权利要求5所述的造口器械,其特征在于,所述支撑部包括 支撑件以及与所述支撑件近端连接的第二连接件,所述支撑件支撑所述抓取件,所述第二连接件近端与所述控制手柄连接。The ostomy apparatus according to claim 5, wherein the support portion includes a support member and a second connection member coupled to the proximal end of the support member, the support member supporting the grasping member, A proximal end of the second connector is coupled to the control handle.
  7. 根据权利要求6所述的造口器械,其特征在于,所述抓取件上设有限位件,所述限位件与所述抓取件之间形成通孔,所述支撑件远端穿过所述通孔。The ostomy apparatus according to claim 6, wherein the grasping member is provided with a limiting member, a through hole is formed between the limiting member and the grasping member, and the supporting member is worn at a distal end. Through the through hole.
  8. 根据权利要求2至7中任一项所述的造口器械,其特征在于,所述抓取件上设有锚定单元。The ostomy apparatus according to any one of claims 2 to 7, wherein the grasping member is provided with an anchoring unit.
  9. 根据权利要求2至7中任一项所述的造口器械,其特征在于,所述所述切割装置还包括控制丝,所述控制丝远端与所述切割件连接,所述控制丝近端与所述控制手柄连接,所述控制手柄通过所述控制丝控制所述切割件运动。The ostomy apparatus according to any one of claims 2 to 7, wherein said cutting device further comprises a control wire, said distal end of said control wire being coupled to said cutting member, said control wire being near An end is coupled to the control handle, and the control handle controls movement of the cutting member by the control wire.
PCT/CN2018/121716 2017-12-29 2018-12-18 Neostomy device WO2019128772A1 (en)

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CN201711484217.4A CN109984809B (en) 2017-12-29 2017-12-29 Ostomy appliance

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CN113040870B (en) * 2019-12-26 2023-03-21 先健科技(深圳)有限公司 Ostomy appliance

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