WO2019218592A1 - 消化道自助吻合夹及其释放装置 - Google Patents

消化道自助吻合夹及其释放装置 Download PDF

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Publication number
WO2019218592A1
WO2019218592A1 PCT/CN2018/111443 CN2018111443W WO2019218592A1 WO 2019218592 A1 WO2019218592 A1 WO 2019218592A1 CN 2018111443 W CN2018111443 W CN 2018111443W WO 2019218592 A1 WO2019218592 A1 WO 2019218592A1
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Prior art keywords
clip
transparent cap
release device
ring
anastomotic
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PCT/CN2018/111443
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English (en)
French (fr)
Inventor
金鸿雁
沈正华
仇卫勤
Original Assignee
南京微创医学科技股份有限公司
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Application filed by 南京微创医学科技股份有限公司 filed Critical 南京微创医学科技股份有限公司
Priority to DE212018000416.1U priority Critical patent/DE212018000416U1/de
Priority to JP2020600198U priority patent/JP3233627U/ja
Priority to KR1020207032645A priority patent/KR102535584B1/ko
Priority to AU2018424055A priority patent/AU2018424055A1/en
Publication of WO2019218592A1 publication Critical patent/WO2019218592A1/zh
Priority to US17/096,257 priority patent/US11857192B2/en

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    • A61B17/1114—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
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Definitions

  • the present invention relates to a medical device, and more particularly to a digestive tract self-assist clip and a release device thereof; the present invention also relates to the specific structure and use of the anastomosis clip and release device.
  • the hemostasis and perforation closure after endoscopic minimally invasive surgery in the clinic are mostly active in the hemostasis mode with hemostasis.
  • the hemostatic clip is clamped by mechanical extrusion.
  • the mucosa layer of the tissue is used to achieve the clipping, and the clip is released and placed in the body.
  • the tissue of the clip portion is necrotic and shedding due to the clamping force, and the clip is discharged through the digestive tract along with the fallen tissue. in vitro.
  • the commonly used clipped hemostatic clip has a retention length of more than 10 mm.
  • the design is designed to easily and quickly repair the acute hemorrhage, fistula, crack, perforation or mucosal defect of the gastrointestinal tract by endoscopy.
  • Patent CN101453957 describes a self-closing tissue fastening device for wound closure and surgery, comprising a central annulus and a tissue puncture that changes from a substantially planar configuration to a substantially cylindrical configuration by applying torsional energy.
  • tissue fastening device has a plurality of protruding portions, which are more irritating to the digestive tract and are discharged to the outside of the body. During the process, the side walls of the digestive tract are also scratched.
  • Patent CN107137119 has improved the design in patent CN101453957 to a certain extent, but does not solve the above problems.
  • tissue fastening device that can overcome the above problems, which can quickly repair the damage of the digestive tract and not easily scratch the digestive tract, and has high stability, not only is not easy to break, and can be stably fixed in the digestive tract damage. Until the wound heals.
  • the existing release device guides for releasing the anastomosis clips on the market are long, and there are many external stabs and/or protrusions on the outside of the guide member, so that the patient is brought into a larger size when entering the patient.
  • the object of the present invention is to design a digestive tract self-adhesive clip and a release device thereof.
  • the anastomosis clip matching release device can quickly close the gastrointestinal tract acute bleeding, fistula, crack and perforation in one time; the product clamping force is large and the clip clamping force is not invalid due to internal and external factors, and the related lesions are also Special requirements for suturing and resection (including full resection) can be achieved; stability is good during the release (clamping) of the anastomosis clip, and it will not break due to local stress concentration; it is less irritating to the digestive tract and is not easy to scratch its side. wall.
  • the invention provides an anastomosis clip, wherein the anastomosis clip comprises a plurality of outer rings, rounded corners and inner thorns are connected in sequence, and the whole connecting structure is centrally symmetrical; the plurality of outer rings are provided with spaces, which are discontinuous Adjacent non-continuous outer rings are connected by the rounded corners, the rounded corners are provided with the inner thorns, and the inner thorns are pointed, and the outer ring is symmetric toward the center Direction, two of the rounded corners are connected in opposite directions to form an S-like shape, and the inner thorn and the outer ring are connected, and the outer ring and the rounded corner are curved in the connecting structure formed, and the whole connection is
  • the structure has no stress concentration.
  • the plurality of outer rings constitute a discontinuous, nearly circular ring with no sharp portions of the protrusion.
  • the plurality of outer rings may also constitute a discontinuous polygon.
  • the internal lance is turned outward from the center of the discontinuous ring, so that the anastomosis clip to be released in the release device has a cylindrical structure.
  • the outer diameter of the anastomosis clip of the cylindrical structure is greater than or equal to the outer diameter of the anastomosis clip when not assembled.
  • the anastomosis clip of the present invention is a superelastic material.
  • the present invention also provides an anastomotic clip release device for assembly and release of the anastomotic clip, wherein the anastomotic clip release device can be used in conjunction with the anastomotic clip.
  • the anastomotic clip releasing device of the present invention comprises a head end, an intermediate flexible tube and a handle; the head end comprises a pull wire, a transparent cap and a connecting soft cap, and one end of the connecting soft cap is connected with the transparent cap, and the other end is endoscope Connected to the mirror, the pull wire passing through the transparent cap is connected to the handle through the intermediate flexible tube, the anastomosis clip can be fitted into the transparent cap, and the anastomotic clip is pressed on the pull line, so that the state to be released is
  • the anastomosis clip is cylindrical.
  • the head end may further include a push ring, the push ring is disposed in the transparent cap, and the push ring and the transparent cap are passed through and connected by a pull wire, passing through The push ring and the pull wire of the transparent cap are connected to the handle through the intermediate flexible tube, the push ring has an axial length smaller than the transparent cap, and the staple clip can be assembled into the transparent cap.
  • a discontinuous ring formed by the outer ring abuts against the push ring such that the anastomotic clip in a state to be released is cylindrical.
  • the pull wires are sequentially connected through the push ring and the transparent cap in order, and an ⁇ -like structure is formed therebetween.
  • the transparent cap has a two-layer structure with a transparent cap hole and a connecting hole.
  • the anastomotic jacket is placed on the inner layer of the transparent cap, the discontinuous ring formed by the outer ring abuts against the push ring, and the top end of the inner thorn does not exceed The end of the transparent cap.
  • the connecting cap is made of an elastic material.
  • the intermediate flexible tube is disposed along the axial direction of the anastomotic clip release device.
  • the wire is threaded in such a manner that one end of the wire is first inserted into two holes on one side of the transparent cap, and then the other end of the wire is passed through the other side of the transparent cap.
  • Two symmetrical holes that are connected to the handle by the intermediate flexible tube after being closed.
  • the threading manner of the wire may be: firstly aligning the respective transparent holes on the transparent cap and the push ring, and then sequentially inserting one end of the wire into the transparent cap. And the hole of the push ring is sequentially passed through the hole of the push ring and the hole of the transparent cap; the other end of the pull wire sequentially passes through the transparent cap and the push in the same manner Four holes that are ring-symmetrical, the wire being connected to the handle through the intermediate flexible tube after being gathered.
  • the wire drawn between the transparent cap and the push ring after assembling the anastomotic clip is of an omega-like structure.
  • the endoscope end is caught in the release device.
  • Figure 1 is a schematic view of the structure of the anastomosis clip
  • Figure 2 is a schematic view of the state in which the anastomotic clip shown in Figure 1 is to be released;
  • Figure 3 is a schematic illustration of the anastomotic clip of Figure 1 in a release device in a state to be released.
  • Figure 4 is a schematic view of the anastomosis clip after release
  • Figure 5 is a schematic view showing the structure of an anastomosis clip of another embodiment
  • Figure 6 is an exploded view of an anastomotic clip release device suitable for use with the anastomotic clip of the present invention
  • Figure 7A is a cross-sectional view of the anastomotic clip release device shown in Figure 6;
  • Figure 7B is a cross-sectional view of the anastomotic clip release device shown in Figure 6
  • Figure 8 is a schematic view showing the threading of the pull wire in the anastomotic clip releasing device shown in Figure 6;
  • Anastomosis clip 1 outer ring 101, 601, inner spur 102, 602, rounded corner 103, 603, head end 2, push ring 201, pull wire 202, transparent cap 203, connecting soft cap 204, transparent cap hole 2031, 2032, line The groove 2033, the connecting hole 2034, the push ring hole 2011, 2012, the intermediate flexible tube 3, the flexible outer tube 301, the inner operation wire 302, the handle 4, the core rod 401, the slider 402, and the endoscope 5.
  • the invention provides an anastomosis clip, the anastomosis clip comprises a plurality of outer rings, rounded corners and inner thorns are connected in sequence, the components are centrally symmetrical, the overall connection structure is centrally symmetrical; and the plurality of outer rings are spaced apart , in a discontinuous shape, the adjacent discontinuous outer rings are connected by four rounded corners, and the outer ring and the rounded corner are combined to form a rounded end connected to the center of the ring.
  • the rounded corner is provided with the inner thorn, the inner thorn is pointed, in the direction of the outer ring toward the central symmetry point, for penetrating the tissue when the clip is clamped, two of the circles
  • the angles are reversely connected to form an S-like shape, and the inner thorn and the outer ring are connected, and the outer ring and the rounded corner are arc-shaped in the formed connecting structure, and the entire connecting structure has no stress concentration point and is stable. More sexual.
  • the plurality of outer rings constitute a discontinuous, nearly circular ring with no sharp portions of the protrusion.
  • the plurality of outer rings may also constitute a discontinuous polygon, and other structures and properties are substantially the same as or similar to those of the circular outer ring embodiment.
  • the outer part of the anastomosis clip has no sharp part of the external protrusion, and the stimulation to the gastrointestinal tract is extremely small. After the product is detached from the body, the discharge of the digestive tract is smoother, and the side wall of the digestive tract channel is not scratched.
  • the internal lance is turned outward from the center of the discontinuous ring, so that the anastomosis clip to be released in the release device has a cylindrical structure.
  • the outer diameter of the anastomosis clip of the cylindrical structure is greater than or equal to the outer diameter of the anastomosis clip when not assembled.
  • the anastomosis clip of the present invention is a superelastic material such as a nickel-titanium alloy material.
  • the present invention also provides an anastomotic clip release device for assembly and release of the anastomotic clip, wherein the anastomotic clip release device can be used in conjunction with the anastomotic clip.
  • the anastomotic clip releasing device of the present invention comprises a head end, an intermediate flexible tube and a handle; the head end comprises a pull wire, a transparent cap and a connecting soft cap, and one end of the connecting soft cap is connected with the transparent cap, and the other end is endoscope Connected to the mirror, the pull wire passing through the transparent cap is connected to the handle through the intermediate flexible tube, the anastomosis clip can be fitted into the transparent cap, and the anastomotic clip is pressed on the pull line, so that the state to be released is
  • the anastomosis clip is cylindrical.
  • the anastomotic clip at this time may be that the outer ring is in contact with the pull wire, that is, when the anastomotic clip is assembled, the outer ring of the anastomosis clip is in direct contact with the pull wire in the transparent cap, so that the horizontal pull wire is subjected to a proximal force.
  • the anastomotic clip at this time may also be a rounded corner in contact with the pull wire and the outer ring is caught between the pull wire and the transparent cap, because the outer ring is discontinuous, and during assembly, several outer rings are stuck into the pull wire and the transparent cap The gap between them is in a state of being hung on the pull wire, so that the pull wire is deformed by the proximal force transmitted from the round corner.
  • the head end may further include a push ring, the push ring is disposed in the transparent cap, and the push ring and the transparent cap are passed through and connected by a pull wire, passing through The push ring and the pull wire of the transparent cap are connected to the handle through the intermediate flexible tube, the push ring has an axial length smaller than the transparent cap, and the staple clip can be assembled into the transparent cap.
  • a discontinuous ring formed by the outer ring abuts against the push ring such that the anastomotic clip in a state to be released is cylindrical.
  • the pull wires are sequentially connected through the push ring and the transparent cap in order, and an ⁇ -like structure is formed therebetween.
  • the transparent cap has a two-layer structure with a transparent cap hole and a connecting hole.
  • the anastomotic jacket is placed on the inner layer of the transparent cap, the discontinuous ring formed by the outer ring abuts against the push ring, and the top end of the inner thorn does not exceed The end of the transparent cap.
  • the connecting cap is made of an elastic material such as a soft rubber.
  • the intermediate flexible tube is disposed along the axial direction of the anastomotic clip release device.
  • the wire is threaded in such a manner that one end of the wire is first inserted into two holes on one side of the transparent cap, and then the other end of the wire is passed through the other side of the transparent cap.
  • Two symmetrical holes that are connected to the handle by the intermediate flexible tube after being closed.
  • the threading manner is as follows: firstly, the transparent cap and the four holes on the push ring are respectively aligned, and then one end of the pull wire is sequentially inserted into the hole of the transparent cap and The hole of the push ring is sequentially passed through the hole of the push ring and the hole of the transparent cap; the other end of the pull wire is sequentially symmetrical through the transparent cap and the push ring in the same manner.
  • the intermediate operation wire in the middle flexible pipe directly connected to the wire can be replaced by the extension wire of the wire.
  • the wire drawn between the transparent cap and the push ring after assembling the anastomotic clip is of an omega-like structure. Therefore, when the anastomosis clip is released, moving the handle to the proximal end can drive the pull wire to move toward the proximal end, thereby driving the ⁇ -type pull wire deformation between the transparent cap and the push ring; and because the pull wire itself has no elasticity, the force is applied.
  • the bottom of the rear type ⁇ -type pull wire tends to be lifted upward, thereby pushing the push ring distally out of the release device, and the staple clip is released from the release device.
  • the presence of the push ring enables the anastomotic clip release process to be more stable than the anastomotic clip release device that does not include a push ring at the head end.
  • the endoscope end is caught in the release device.
  • the connecting cap at the head end of the release device is made of an elastic material, and the endoscope is directly inserted into the connecting cap to clamp the end portion thereof into the connecting cap to be fixedly connected with the releasing device.
  • an anastomosis clip of an embodiment of the present invention is illustrated.
  • the anastomotic clip includes an outer ring 101, an inner thorn 102, and a fillet 103.
  • FIG. 1 it is a schematic diagram of a structure of an anastomosis clip constructed and operated according to an embodiment of the present invention
  • FIG. 2 is a schematic structural view of the anastomosis clip shown in FIG. 1 in a state to be released
  • 3 is a schematic view showing the structure of the circular anastomosis clip shown in FIG. 1 in a state in which the release device is to be released.
  • the inner thorn 102, the round corner 103 and the outer ring 101 are sequentially connected, and the components are centrally symmetrical.
  • the rounded corners 103 are arcuate structures close to a semicircle; a plurality of outer rings 101 are formed with spaced apart discontinuous rings on the outermost sides of the staple clips, and adjacent discontinuous outer rings 101 are connected by four rounded corners 103
  • the outer ring 101 and the rounded corner 103 are combined to form a streamlined shape at the rounded corner 103 which is concavely connected to the center of the ring.
  • the entire connecting structure has no stress concentration point; one end of the inner thorn 102 is connected to the rounded corner 103, and the inner thorn 102 is along
  • the outer ring 101 is centrally symmetrical with respect to the direction of the central symmetry point, and the other end has a pointed shape for penetrating the tissue when the clip is clamped.
  • the inner thorn 102 can also symmetrically distribute a plurality of sharp corners for assisting the piercing and Clamping the tissue to be closed; adjacent discontinuous outer rings 101 are connected by four rounded corners 103, preferably between the outer ring 101 and the inner spurs 102, and the outer ring 101 is oriented towards the center of the discontinuous ring
  • the two 102 arcuate rounded corners 103 are connected in opposite directions to form an S-like type, and the inner thorn 102 and the outer ring 101 are joined together.
  • the outer ring 101 and the rounded corner 103 connected thereto are in an arc shape.
  • the anastomotic clip of the invention can not only avoid the local application when the shape changes Concentration also makes the stability of the anastomosis clip higher during the morphological transformation, that is, the clamping force of the anastomotic clip of the present invention is larger than that of the linear connection or other connection between the internal spur 102 and the outer ring 101. The force required to change is also greater; the S-like fillets are axially symmetrically distributed in the outer ring 101 toward the center of the discontinuous ring.
  • each outer ring 101 When the anastomosis clip of the present invention is in a stationary state, as shown in FIG. 1, each outer ring 101 has an outwardly curved arc shape, and all outer rings 101 form a discontinuous ring, and there is no sharp portion of the protrusion, facing the stomach.
  • the irritation of the intestine is extremely small. After the product is detached from the body, the discharge of the digestive tract is smoother and does not scratch the side wall of the digestive tract.
  • the outer diameter of the anastomosis clip of the present invention is 20-30% smaller in a planar state, and the same tissue capacity can be obtained, thereby effectively alleviating The patient's foreign body sensation and reduced damage to the surrounding healthy tissue when the anastomosis is clamped.
  • the internal spur 102 is folded outward from the center of the discontinuous ring such that the plane in which the internal spur 102 is located is substantially perpendicular to The plane in which the discontinuous rings are located; the distance between adjacent outer rings 101 tends to increase, and the outer diameter of the discontinuous rings formed by the plurality of outer rings 101 is greater than or equal to the discontinuous ring that is not assembled to the release device. Outer diameter.
  • the anastomosis clip of the present invention has a curved shape which is linear or outwardly curved due to the outer ring 101. Since the outer diameter of the ring is the same, the area of the tissue which the prior art outer ring 101 is recessed inwardly can hold the tissue.
  • the anvil clip is smaller than the outer ring 101 of the present invention; therefore, the outer diameter of the anastomosis clip of the present invention is smaller than that of the similar product under the premise of clamping the same amount of tissue.
  • FIG. 4 is a schematic view showing the structure of the anastomosis clip after the release of the anastomosis clip.
  • the anastomosis clip of the present invention has a cylindrical structure assembled to the release device, and the axial length of the cylindrical structure is short.
  • the designed releaser tip length will be shorter, which is more favorable for passing through the natural cavity of the human body; and the bottom surface is nearly flat to facilitate installation on the release device.
  • the anastomosis clip is a super-elastic material, an internal spur 102, a continuous integral streamline formed by the outer ring 101 and the rounded corner 103, and the structure is not only beautiful, but also has no stress concentration portion to be avoided in the mechanical structure, so compared with the existing In the technique of the anastomosis clip, the anastomosis clip of the invention has higher reliability and stability, and effectively reduces the probability of breakage of the anastomotic clip when the external force is changed to the state to be released, so that the function of the closed tissue can be more stably exerted. To avoid the possibility of secondary injury to the patient due to the quality of the anastomosis clip itself.
  • FIG. 4 is a schematic view of the anastomosis clip of the present invention after release; after the anastomotic clip is released by the release device, the tip end of the internal stab 102 creates a clamping force between each other, and the diseased tissue is well-defined in the outer ring 101.
  • the tip of the internal spur 102 needs to be subjected to a tip grinding process.
  • the internal thorn 102 is not limited to the number and length shown in the drawings.
  • the anastomotic clip 1 includes an outer ring 601, an internal thorn 602, and a fillet 603.
  • the outer ring 601 can also be a polygonal structure.
  • the single outer ring 601 has no curvature, but since the end of the outer ring 601 is connected to the rounded corner 603, there is no sharp portion of the outer protrusion, and the stimulation to the digestive tract is relatively small.
  • the anastomosis clip 1 of the present embodiment has substantially the same or similar anastomosis clip as the outer ring 101 embodiment except that the outer ring 601 is polygonal.
  • anastomosis clip of the present invention can be used in conjunction with any matching anastomotic clip release device for the assembly and release of the anastomosis clip.
  • a release device suitable for use with the anastomotic clip of the present invention includes a head end 2, an intermediate flexible tube 3, a handle 4; the head end 2 includes a push ring 201, the pull wire 202, the transparent cap 203 and the connecting flexible cap 204; the intermediate flexible tube 3 comprises a flexible outer tube 301 and an intermediate operating wire 302, the handle 4 comprising a core rod 401 and a slider 402.
  • the push ring 201 has a push ring hole 2011, 2012;
  • the transparent cap 203 has a transparent cap hole 2031, 2032, a wire groove 2033 and a connecting hole 2034.
  • the intermediate operating wire 302 can be replaced by an extension of the pull wire 202.
  • the transparent cap 203 is a two-layer structure having transparent cap holes 2031, 2032, a wire slot 2033 and a connecting hole 2034.
  • the push ring 201 is a single layer structure having push ring holes 2011 and 2012; the push ring 201 is placed in a double layer transparent cap. In the middle interlayer of 203, the push ring 201 and the transparent cap 203 are passed through and connected by the pull wire 202. The axial length of the push ring 201 is smaller than that of the transparent cap 203.
  • the inner thorn of the staple clip 1 is folded outward from the center of the discontinuous ring, so that the anastomotic clip 1 to be released in the release device is released.
  • the cylindrical structure anastomosis clip 1 is placed on the inner layer of the double-layer structure transparent cap 203, and the outer ring 101 abuts against the push ring 201, and the top end of the inner thorn does not exceed the end of the transparent cap 203.
  • connection mode of the connecting cap 204 and the endoscope 5 is a snapping manner, because the connecting cap 204 is made of an elastic material such as soft PVC or silicone. Or a soft rubber or the like, the endoscope 5 is directly inserted into the connecting flexible cap 204, and the end portion thereof is caught in the connecting soft cap 204 to be fixedly connected with the releasing device; therefore, the releasing device of the present invention is fixed to the endoscope. Simple, taking up less treatment time.
  • the intermediate flexible tube 3 is disposed along the axial direction of the release device, and the distal end of the intermediate operation wire 302 is connected to the pull wire 202 through the connection hole 2034, and the proximal end is connected to the handle 4.
  • the head end 2 of the release device is relatively short, and therefore, the release device of the present invention has less damage to the side wall of the gastrointestinal tract when passing through the curved gastrointestinal tract; and further reduces because there are no thorns or protrusions on the outside of the entire release device Damage to human tissue.
  • FIG. 7A and 7B are respectively an assembled view and a cross-sectional view of the head end of the anastomotic clip 1 release device and a portion of the intermediate flexible tube 3 shown in Fig. 6.
  • 8 is a schematic view of the threading of the pull wire in the anastomotic clip release device shown in FIG. 6.
  • the specific threading manner is as follows: firstly, the four holes of the transparent cap 203 and the push ring 201 are respectively aligned, and then one end of the pull wire 202 is first worn at the same time.
  • the transparent cap hole 2031 and the push ring hole 2011 are sequentially passed through by the push ring hole 2012 and the transparent cap hole 2032; the other end of the pull wire 202 sequentially passes through the transparent cap 203 and the four holes symmetrically of the push ring 201 in the same manner.
  • the last two strands are aligned and merged into the connecting hole 2034 as shown in FIG. 7B.
  • the pulling wire 202 between the transparent cap 203 and the push ring 201 is in the form of an ⁇ -like type as shown in FIG. 8 , and the wire is tightened after the wire 202 is tightened.
  • the body is just embedded in the slot 2033.
  • the handle 4 When the anastomosis clip is released, the handle 4 is moved to the proximal end to drive the intermediate flexible tube 3 connected to the handle 4 to move proximally, and because the middle operation wire 302 is connected to the pull wire 202, the intermediate flexible tube 3 moves toward the proximal end.
  • the pull wire 202 passing through the connecting hole 2034 is forced to move toward the proximal end, thereby driving the wire 202 passing between the transparent cap 203 and the push ring 201 to deform, because the wire 202 itself has no elasticity, and is placed on the transparent cap 203 and the push ring after being stressed.
  • the ⁇ -type pull wire 202 between the 201 is deformed by force, in particular, both sides of the ⁇ -like type are subjected to an outward pulling force, so that the bottom of the ⁇ -like type tends to be lifted upward, thereby pushing the push ring 201 distally.
  • the release device releases the anastomotic clip 1 from the release device. Therefore, when the release action occurs, the force received by the anastomotic clip 1 comes from the two-stage pull wire, and since the push ring 201 and the pull wire 202 are symmetrically distributed, the shorter head end 2 serves as a guide to complete the action of releasing the anastomosis clip 1. .
  • the pull wire 202 may be any material for the human body, and is not limited to a non-metal material or a metal material, and may preferably be a stainless steel wire, a nickel titanium wire or a PTFE wire or the like.
  • the preoperative evaluation is performed according to the normal operation to determine the condition and position of the patient, and the release device pre-assembled with the anastomosis clip 1 is assembled with the endoscope 5, and delivered to the lesion, and the endoscope 5 is adjusted.
  • the ⁇ -type cable 202 located between the transparent cap 203 and the push ring 201 after being subjected to force is deformed by force, and specifically, both sides of the ⁇ -like type are subjected to outward pulling force, and thus The bottom of the ⁇ -type pull wire tends to be lifted upward, thereby pushing the push ring 201 distally out of the release device, and the staple clip 1 is released from the release device.
  • the anastomotic clip 1 When the anastomotic clip 1 is fixed in the release device, it is in a state to be released; after being pushed out from the release device, according to the principle of minimum energy, since the anastomotic clip 1 is composed of a superelastic material, the anastomotic clip 1 is assembled into the release device in a cylindrical shape. In the structure, the anastomotic clip 1 will store a certain elastic potential energy; therefore, after the anastomotic clip 1 is withdrawn from the release device, that is, after the external force is removed, the elastic potential energy is converted into kinetic energy, so that the anastomotic clip 1 will quickly clamp the root of the wound to realize the clip. Closed function.
  • the anastomosis clip 1 will always remain in a plane static state without any external force, until the wound tissue is self-repaired, the tissue of the clip portion is necrotic and shedding due to the clamping force, and the anastomosis clip 1 is separated from the tissue. Together with the digestive tract excreted.
  • the anastomosis clip 1 is in a state of being close to an arc regardless of whether the plane is stationary or to be released, thereby avoiding unnecessary damage to the human body during use.

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Abstract

一种吻合夹（1）及其释放装置，吻合夹（1）包括依次相连的内刺（102、602）、圆角（103、603）和外环（101、601）；释放装置可以和吻合夹（1）匹配使用，该释放装置包括头端（2）、中间柔性管（3）和手柄（4）。

Description

消化道自助吻合夹及其释放装置 技术领域
本发明涉及一种医疗器械，特别是涉及一种消化道自助吻合夹及其释放装置；本发明还涉及此吻合夹及释放装置的具体结构和使用方式。
背景技术
随着内镜微创技术的发展，目前临床上内窥镜微创手术后的止血、穿孔的闭合绝大部分是以止血夹为主的止血方式活跃于临床，止血夹利用机械挤压原理夹持组织的黏膜层来实现夹闭，夹子释放后留置于体内，待创面组织自行修复完成后，夹闭部分的组织由于夹持力的作用坏死、脱落，夹子随脱落的组织一起经消化道排出体外。目前，常用的夹闭的止血夹滞留长度在10mm以上，绝大部分夹子在释放之后与消化道壁垂直，且夹子大多夹住的是黏膜层，很有可能因为消化系统蠕动、进食或腹部外力等原因导致夹子移位或脱落。特别是临床上出现较大创面或穿孔时，止血夹因其夹持力小、开口尺寸有限等原因难以达到有效的闭合效果。内镜缝合装置(OTSC)对于大创面和穿孔有很好的闭合作用，但是因其器械安装的复杂性，且其费用昂贵，故此项技术很难在国内临床上展开普遍使用。
故此消化道自助吻合夹就应运而生，该设计旨在通过内镜能简单快捷的对胃肠道急性出血、瘘管、裂缝、穿孔或者黏膜缺损进行相应的修补。
专利CN101453957描述了一种用于伤口闭合和手术的自行闭合的组织紧固装置，包括中心环和组织刺穿刺，通过施加扭转能量而从实质上平面的结构改变为实质上圆柱形构造。但在扭转过程中会存在局部应力集中，从而导致产品稳定性较差而发生断裂破损；且该组织紧固装置的最外侧有若干突起部位，对消化道的刺激较大，在向体外的排出过程中，也会划伤消化道侧壁。
专利CN107137119在一定程度上改进了专利CN101453957中的设计，但并没有解决上述问题。
因此迫切需要一种可克服上述问题的组织紧固装置，既能快捷的修补消化道破损，又不易划伤消化道，且稳定性较高，不仅不易断裂，且能稳定的固定在消化道破损处直至伤口愈合。
同时目前市场上现有的用于释放吻合夹的释放装置导向件较长，且导向件外部多存在多处外刺和/或凸起，因此在进入患者体内时会给患者带来较大的伤害；在配合内镜使用时，往往需要先用橡胶圈等连接配件将内镜与导向件固定后方可使用，操作复杂且费时。因此一种能操作简便且对患者损伤小的释放装置也是迫切需要的。
发明内容
本发明的目的，是设计一种消化道自助吻合夹及其释放装置。该吻合夹配合释放装置能快速的一次性闭合消化道胃肠道急性出血、瘘管、裂缝和穿孔；产品夹持力大且不会因为内、外部因素导致夹子夹持力失效，对于相关病变还可以实现先缝合再切除(包括全程切除)的特殊需求；在吻合夹的释放(夹持)过程中稳定性好，不会因为局部应力集中而断裂；对消化道刺激小，不易划伤其侧壁。
本发明提供了一种吻合夹，所述吻合夹包括多个外环、圆角和内刺依次相连，整体连接结构呈中心对称；所述多个外环之间设有间隔，呈不连续状，相邻的不连续的所述外环之间由所述圆角相连，所述圆角上设有所述内刺，所述内刺呈尖状，在所述外环朝向中心对称点的方向，两个所述圆角反向相连形成类S型后连接所述内刺与所述外环，所形成的连接结构中所述外环与所述圆角之间呈弧形，整个连接结构无应力集中部位。
本发明的吻合夹，所述多个外环组成一个不连续的近乎圆形的环，无外突的尖锐部分。
本发明的吻合夹，所述多个外环还可以组成一个不连续的多边形。
本发明的吻合夹，所述吻合夹装配到释放装置时，其内刺从不连续的环的圆心向外翻，使得位于释放装置内待释放的吻合夹呈筒状结构。
本发明的吻合夹，呈筒状结构的吻合夹外径大于等于未装配时的吻合夹外径。
本发明的吻合夹为超弹性材质。
本发明还提供了一种用于所述吻合夹的装配和释放的吻合夹释放装置，其特征在于，所述吻合夹释放装置可以与所述吻合夹匹配使用。
本发明的吻合夹释放装置，包括头端、中间柔性管、手柄；所述头端包括拉线、透明帽和连接软帽，所述连接软帽一端与所述透明帽相连，另一端与内 窥镜相连，穿过所述透明帽的拉线通过所述中间柔性管相连至所述手柄，所述吻合夹可以装配到所述透明帽内，吻合夹压在所述拉线上，使得待释放状态的所述吻合夹呈筒状。
本发明的吻合夹释放装置，所述头端还可以包括推环，所述推环置于所述透明帽内，所述推环与所述透明帽之间由拉线穿过并连接，穿过所述推环和所述透明帽的拉线通过所述中间柔性管相连至所述手柄，所述推环的轴向长度小于所述透明帽，所述吻合夹可以装配到所述透明帽内，其外环形成的不连续的环抵靠在所述推环上，使得待释放状态的所述吻合夹呈筒状。
本发明的吻合夹释放装置，所述拉线按顺序依次穿过所述推环和所述透明帽将两者相连，且在两者之间形成类Ω型结构。
本发明的吻合夹释放装置，所述透明帽为其上带有透明帽孔和连接孔的双层结构。
本发明的释放装置，吻合夹套在所述透明帽的靠内侧一层上，其所述外环形成的不连续的环抵靠在所述推环上，且所述内刺的顶端不超出所述透明帽的端部。
本发明的释放装置，所述连接软帽由弹性材质构成。
本发明的释放装置，所述中间柔性管沿吻合夹释放装置的轴向设置。
本发明的释放装置，其拉线的穿线方式为：首先将所述拉线的一端穿入所述透明帽一侧的两个孔，然后将所述拉线的另一端穿过所述透明帽另一侧对称的两个孔，所述拉线合拢之后通过所述中间柔性管连接至所述手柄。
本发明的释放装置，其拉线的穿线方式还可以为：首先将所述透明帽及所述推环上各自的四个孔分别对齐，随后将所述拉线的一端先顺序穿入所述透明帽的孔及所述推环的孔，再由所述推环的孔及所述透明帽的孔顺序穿出；所述拉线的另一端以同样的方式顺序穿过所述透明帽及所述推环对称的四个孔，所述拉线收拢之后通过所述中间柔性管连接至所述手柄。
本发明的释放装置，装配吻合夹后位于所述透明帽和所述推环之间的所述拉线为类Ω型结构。
本发明的释放装置，内窥镜端部卡在所述释放装置内。
附图说明
图1是吻合夹结构示意图；
图2是图1所示的吻合夹待释放状态的示意图；
图3是图1所示的吻合夹位于释放装置中呈待释放状态的示意图。
图4是吻合夹释放后的示意图；
图5是另一种实施方式的吻合夹结构示意图；
图6是适用于本发明吻合夹的吻合夹释放装置的爆炸图；
图7A是图6所示的吻合夹释放装置剖视图；
图7B是图6所示的吻合夹释放装置剖视图
图8是图6所示的吻合夹释放装置中拉线的穿线示意图；
附图标号说明
吻合夹1，外环101、601，内刺102、602，圆角103、603，头端2，推环201，拉线202，透明帽203，连接软帽204，透明帽孔2031、2032，线槽2033，连接孔2034，推环孔2011、2012，中间柔性管3，柔性外管301，内部操作丝302，手柄4，芯杆401，滑块402，内窥镜5。
具体实施方式
以下结合附图对本发明技术方案进行详细说明。应当理解，此处所描述的具体实施方式仅用以解释本发明，并不用于限定本发明。本申请的范围并不受这些实施方式的限定，乃以申请专利的范围为准。而为提供更清楚的描述及使熟悉该项技艺者能理解本申请的申请内容，图示内各部分并不一定依照其相对的尺寸而绘图，某些尺寸与其他相关尺度的比例会被凸显而显得夸张，且不相关或不重要的细节部分亦未完全绘出，以求图示的简洁。
本发明提供了一种吻合夹，所述吻合夹包括多个外环、圆角和内刺依次相连，各部件中心对称，整体连接结构呈中心对称；所述多个外环之间设有间隔，呈不连续状，相邻的不连续的所述外环之间由四个圆角相连，所述外环与所述圆角组合连接形成于圆角处向环中心内凹的首尾相连的流线型；所述圆角上设有所述内刺，所述内刺呈尖状，在所述外环朝向中心对称点的方向，用于吻合夹夹闭时穿透组织，两个所述圆角反向相连形成类S型后连接所述内刺与所述外环，所形成的连接结构中所述外环与所述圆角之间呈弧形，整个连接结构无应力集中点，稳定性更高。
本发明的吻合夹，所述多个外环组成一个不连续的近乎圆形的环，无外突的尖锐部分。所述多个外环还可以组成一个不连续的多边形，其它结构和性能 与圆形外环实施方式的吻合夹基本相同或相近。吻合夹的外侧无外突的尖锐部分，对胃肠道的刺激极小，产品从体内脱落后，随消化道的排出更顺畅，不会划伤消化道通道侧壁。
本发明的吻合夹，所述吻合夹装配到释放装置时，其内刺从不连续的环的圆心向外翻，使得位于释放装置内待释放的吻合夹呈筒状结构。
本发明的吻合夹，呈筒状结构的吻合夹外径大于等于未装配时的吻合夹外径。
本发明的吻合夹为超弹性材质，比如镍钛合金材质。
本发明还提供了一种用于所述吻合夹的装配和释放的吻合夹释放装置，其特征在于，所述吻合夹释放装置可以与所述吻合夹匹配使用。
本发明的吻合夹释放装置，包括头端、中间柔性管、手柄；所述头端包括拉线、透明帽和连接软帽，所述连接软帽一端与所述透明帽相连，另一端与内窥镜相连，穿过所述透明帽的拉线通过所述中间柔性管相连至所述手柄，所述吻合夹可以装配到所述透明帽内，吻合夹压在所述拉线上，使得待释放状态的所述吻合夹呈筒状。此时的吻合夹可以是外环与拉线相接触，即在吻合夹装配时，由吻合夹的外环与透明帽内的拉线直接接触，使得水平状的拉线受到一个向近端的力而发生形变；此时的吻合夹还可以是圆角与拉线相接触而外环卡在拉线和透明帽之间，因为外环是不连续的，在装配时，若干段外环卡进拉线与透明帽之间的缝隙，呈挂在拉线上的状态，使得拉线受到自圆角处传来的向近端的力而发生形变。
本发明的吻合夹释放装置，所述头端还可以包括推环，所述推环置于所述透明帽内，所述推环与所述透明帽之间由拉线穿过并连接，穿过所述推环和所述透明帽的拉线通过所述中间柔性管相连至所述手柄，所述推环的轴向长度小于所述透明帽，所述吻合夹可以装配到所述透明帽内，其外环形成的不连续的环抵靠在所述推环上，使得待释放状态的所述吻合夹呈筒状。
本发明的吻合夹释放装置，所述拉线按顺序依次穿过所述推环和所述透明帽将两者相连，且在两者之间形成类Ω型结构。
本发明的吻合夹释放装置，所述透明帽为其上带有透明帽孔和连接孔的双层结构。
本发明的释放装置，吻合夹套在所述透明帽的靠内侧一层上，其所述外环 形成的不连续的环抵靠在所述推环上，且所述内刺的顶端不超出所述透明帽的端部。
本发明的释放装置，所述连接软帽由弹性材质构成，比如软胶。
本发明的释放装置，所述中间柔性管沿吻合夹释放装置的轴向设置。
本发明的释放装置，其拉线的穿线方式为：首先将所述拉线的一端穿入所述透明帽一侧的两个孔，然后将所述拉线的另一端穿过所述透明帽另一侧对称的两个孔，所述拉线合拢之后通过所述中间柔性管连接至所述手柄。当头端包含推环时，其穿线方式为：首先将所述透明帽及所述推环上各自的四个孔分别对齐，随后将所述拉线的一端先顺序穿入所述透明帽的孔及所述推环的孔，再由所述推环的孔及所述透明帽的孔顺序穿出；所述拉线的另一端以同样的方式顺序穿过所述透明帽及所述推环对称的四个孔，所述拉线收紧之后通过所述中间柔性管连接至所述手柄。其中中间柔性管中与拉线直接相连的中间操作丝可以由拉线的延长线替代。本发明的释放装置，装配吻合夹后位于所述透明帽和所述推环之间的所述拉线为类Ω型结构。因此在释放吻合夹时，将手柄向近端移动，就可以带动拉线向近端移动，从而带动穿过透明帽和推环之间的类Ω型拉线形变；又因拉线本身没有弹性，受力后类Ω型拉线的底部趋于向上抬起的状态，从而将推环向远端推出释放装置，吻合夹从释放装置中释放。相较于头端不包括推环的吻合夹释放装置，推环的存在能使得吻合夹释放过程更稳定。
本发明的释放装置，内窥镜端部卡在所述释放装置内。具体为释放装置头端的连接软帽为弹性材质，内窥镜直插进入连接软帽即可将其端部卡在连接软帽内，从而与释放装置固定连接。
如图1至图5所示，其示意了本发明实施方式的吻合夹。
在本发明的非限制性实施方式中，吻合夹包括外环101、内刺102和圆角103。如图1所示，其示意了根据本发明的实施方式构造及操作的吻合夹结构示意图，图2为图1所示的吻合夹呈待释放状态的结构示意图。图3为图1所示的圆形吻合夹位于释放装置中呈待释放状态的结构示意图。其中内刺102、圆角103和外环101依次相连，各部件中心对称。其中圆角103为接近半圆的弧形结构；若干个外环101在吻合夹的最外侧形成有间隔的不连续的环，相邻的不连续的外环101之间由四个圆角103相连；外环101与圆角103组合连接形成圆角103处向环的中心内凹的首尾相连的流线型，整个连接结构无应力集中点； 内刺102的一端与圆角103相连，内刺102沿外环101指向中心对称点的方向呈中心对称，其另一端为尖状，用于吻合夹夹闭时穿透组织，在内刺102上还可以对称分布若干尖角，用于辅助刺穿并夹持住需要闭合的组织；相邻的不连续的外环101之间由四个圆角103相连，优选地，在外环101与内刺102之间、外环101朝向不连续环圆心方向，两个102弧形圆角103反向相连形成类S型后将内刺102与外环101连接到一起，所形成的结构中外环101与它相连接的圆角103呈弧形结构，本发明的吻合夹不仅能避免其在形态变化时产生局部应力集中，还使得吻合夹在形态转变时的稳定性更高，即相较于内刺102与外环101之间的直线连接或其它连接方式，本发明的吻合夹夹持力更大，发生形态变化时所需的力也更大；类S型圆角在外环101朝向不连续环圆心方向呈轴对称分布。
本发明的吻合夹在静止状态时，如图1所示，每一外环101均呈向外弯曲的弧形，所有外环101形成一个不连续的环，无外突的尖锐部分，对胃肠道的刺激极小，产品从体内脱落后，随消化道的排出更顺畅，不会划伤消化道通道侧壁。并且相较于外环101向内弯曲的现有产品的吻合夹，本发明的吻合夹在平面状态下的外径要小20-30％就能获得相同的组织容量，因此能有效的缓解给患者的异物感和减轻吻合夹在夹持组织时对周围健康的组织带来的伤害。
如图2和图3所示，本发明的吻合夹在装配到释放装置呈待释放状态时，内刺102从不连续的环的圆心向外翻折，使得内刺102所在的平面基本垂直于不连续环所在的平面；相邻外环101间的距离趋于增大，吻合夹多个外环101所形成的不连续环的外径大于或等于未装配到释放装置时的不连续环的外径。
本发明的吻合夹因其外环101为直线型或向外弯曲的弧形，由于在环外径相同的情况下，现有技术外环101向内凹陷的吻合夹能夹持的组织的区域小于本发明外环101向外弯曲的吻合夹；因此在夹持相同组织量的前提下，本发明的吻合夹外径比同类产品小。如图4所示为吻合夹释放后夹持组织的示意图，因为外径较小，本发明的吻合夹在装配到释放装置上呈筒状结构，筒状结构的轴向长度较短，这样配套设计的释放器头端长度会更短，更有利于通过人体的自然腔道；且底面呈现近乎平面状态，便于在释放装置上的安装。
吻合夹整体为超弹性材质，内刺102，外环101与圆角103形成的连贯整体流线型，此结构不仅美观，而且不存在机械结构中需避免存在的应力集中部位， 因此相较于现有技术中的吻合夹，本发明的吻合夹可靠性和稳定性更高，有效减小当吻合夹在受到外力变为待释放状态时破损的几率，使其能更稳定的发挥其闭合组织的功能，避免因吻合夹本身品质问题给患者带来二次伤害的可能性。
图4是本发明吻合夹释放后的示意图；吻合夹经释放装置释放后，内刺102尖端之间相互产生夹持力，将病变组织很好的圈定于外环101内部。为了增加内刺102的穿透力以及更好的保护人体内壁组织，此内刺102尖端需要进行尖端磨削处理。特别说明此处内刺102不限于图样所示的数量和长短。
在本发明的非限制性实施方式中，吻合夹1包括外环601、内刺602和圆角603。如图5所示，其示意了根据本发明的另一个实施方式构造及操作的吻合夹结构示意图。外环601还可以为多边形结构，单个外环601没有弧度，但因为外环601末端是与圆角603相连，所以没有外突的尖锐部分，对消化道的刺激会比较小。本实施方式的吻合夹1除了外环601为多边形之外，其它结构和性能与外环101实施方式的吻合夹基本相同或相近。
特别说明的是，本发明的吻合夹可配合任意一款与之匹配的吻合夹释放装置进行吻合夹的装配和释放过程。
在本发明的非限制性实施方式中，如图6到图8所示，一种适用于本发明吻合夹的释放装置包括头端2、中间柔性管3、手柄4；头端2包括推环201、拉线202、透明帽203和连接软帽204；中间柔性管3包括柔性外管301和中间操作丝302，手柄4包括芯杆401和滑块402。其中推环201上有推环孔2011、2012；透明帽203上有透明帽孔2031、2032、线槽2033和连接孔2034。其中中间操作丝302可以由拉线202的延长线替代。
如图6所示为该释放装置的爆炸图，靠近手柄4的一侧为近端，远离手柄4的一侧为远端。其中透明帽203为具有透明帽孔2031、2032、线槽2033和连接孔2034的双层结构，推环201为具有推环孔2011、2012的单层结构；推环201放置在双层透明帽203的中间夹层内，推环201与透明帽203之间由拉线202穿过并连接。推环201的轴向长度小于透明帽203，吻合夹1装配到释放装置时，吻合夹1的内刺从不连续的环的圆心向外翻折，使得位于释放装置内待释放的吻合夹1呈筒状结构，筒状结构吻合夹1套在双层结构透明帽203的靠内侧一层上，其外环101抵靠在推环201上，内刺的顶端不超出透明帽203的端部。连接软帽204一端套在透明帽203上，另一端连接内窥镜5；连接软帽204与内 窥镜5的连接方式为卡扣方式，因连接软帽204由弹性材质比如软PVC、硅胶或软胶等构成，将内窥镜5直插进入连接软帽204即可将其端部卡在连接软帽204内，从而与释放装置固定连接；因此本发明的释放装置与内窥镜固定简易，占用治疗时间少。中间柔性管3沿释放装置的轴向设置，其中间操作丝302的远端穿过连接孔2034与拉线202相连，近端与手柄4相连。释放装置的头端2较短，因此，本发明的释放装置在通过弯曲的胃肠道时，对胃肠道侧壁的损伤较小；且因为整个释放装置的外部没有刺或者突起，进一步减少了对人体组织的伤害。
图7A和7B分别为图6所示的吻合夹1释放装置头端和部分中间柔性管3的装配图和剖视图。图8为图6所示的吻合夹释放装置中拉线的穿线示意图，具体穿线方式为：首先将透明帽203及推环201上各自的四个孔分别对齐，随后将拉线202的一端先同时穿入透明帽孔2031及推环孔2011，再由推环孔2012及透明帽孔2032顺序穿出；拉线202的另一端以同样的方式顺序穿过透明帽203及推环201对称的四个孔，最后两股线头对齐汇合再穿入如图7B所示的连接孔2034，位于透明帽203和推环201之间的拉线202如图8所示为类Ω型存在，拉线202收紧之后线体刚好嵌入线槽2033内。
释放吻合夹时，将手柄4向近端移动，带动与手柄4相连的中间柔性管3向近端移动，又因为其中间操作丝302与拉线202相连，因此中间柔性管3向近端移动又迫使穿过连接孔2034的拉线202向近端移动，从而带动穿过透明帽203和推环201之间的拉线202形变，因拉线202材料本身没有弹性，受力后位于透明帽203和推环201之间的类Ω型拉线202受力发生形变，具体为类Ω型的两侧均受到向外的拉力，从而类Ω的底部趋于向上抬起状态，从而将推环201向远端推出释放装置，吻合夹1从释放装置中释放。因此释放动作发生时，吻合夹1受到的力来自于两段拉线，又因为推环201和拉线202是对称分布的，因此较短的头端2作为导向件即可完成释放吻合夹1的动作。
拉线202可为任何用于人体的材料，不限于非金属材料或金属材料，优选地，可以为不锈钢丝、镍钛丝或PTFE线等。
释放装置在使用时，按照正常手术进行术前评估，确定患者病变情况及位置，将预装好吻合夹1的释放装置与内窥镜5装配，并送达至病变处，调整内窥镜5的角度，必要时利用配套器械抓取或负压吸引创面至远端透明帽203内 部；将手柄4向近端移动，带动与手柄4相连的中间柔性管3向近端移动，又因为其中间操作丝302与拉线201相连，因此中间柔性管3向近端移动又迫使穿过连接孔2034的拉线202向近端移动，从而带动穿过透明帽203和推环201之间的类Ω型拉线202形变，因拉线202本身没有弹性，受力后位于透明帽203和推环201之间的Ω型拉线202受力发生形变，具体为类Ω型的两侧均受到向外的拉力，从而类Ω型拉线的底部趋于向上抬起的状态，从而将推环201向远端推出释放装置，吻合夹1从释放装置中释放。
吻合夹1固定在释放装置内时呈待释放状态；从释放装置上被推出后，依据能量最小原理，因为吻合夹1是由超弹性材料构成，所以吻合夹1在装配到释放装置呈筒状结构时，吻合夹1会储存一定的弹性势能；因此吻合夹1从释放装置退出后，即外力去除后，弹性势能会转化为动能，从而吻合夹1会快速的夹持住创面根部，实现夹闭功能。此时的吻合夹1在没有其他外力的前提下会始终保持平面静止状态，直至创面组织自行修复完成后，夹闭部分的组织由于夹持力的作用坏死、脱落，吻合夹1随脱落的组织一起经消化道排出体外。
吻合夹1无论平面静止或待释放状态，外环均呈现接近弧形的状态，避免使用过程中对人体造成不必要的伤害。

Claims (18)

  1. 一种吻合夹，其特征在于，所述吻合夹包括多个外环、圆角和内刺依次相连，整体连接结构呈中心对称；所述多个外环之间设有间隔，呈不连续状，相邻的不连续的所述外环之间由所述圆角相连，所述圆角上设有所述内刺，所述内刺呈尖状，在所述外环朝向中心对称点的方向，两个所述圆角反向相连形成类S型后连接所述内刺与所述外环，所形成的连接结构中所述外环与所述圆角之间呈弧形。
  2. 根据权利要求1所述的吻合夹，其特征在于，所述多个外环组成一个不连续的近乎圆形的环，无外突的尖锐部分。
  3. 根据权利要求1所述的吻合夹，其特征在于，所述多个外环还可以组成一个不连续的多边形。
  4. 根据权利要求1所述的吻合夹，其特征在于，所述吻合夹装配到释放装置时，其内刺从不连续的环的圆心向外翻，使得位于释放装置内待释放的吻合夹呈筒状结构。
  5. 根据权利要求4所述的吻合夹，其特征在于，呈筒状结构的吻合夹外径大于等于未装配时的吻合夹外径。
  6. 根据权利要求1所述的吻合夹，其特征在于，所述吻合夹为超弹性材质。
  7. 一种用于权利要求1所述吻合夹的装配和释放的吻合夹释放装置，其特征在于，所述吻合夹释放装置可以与所述吻合夹匹配使用。
  8. 根据权利要求7所述的吻合夹释放装置，其特征在于，所述吻合夹释放装置包括头端、中间柔性管、手柄；所述头端包括拉线、透明帽和连接软帽，所述连接软帽一端与所述透明帽相连，另一端与内窥镜相连，穿过所述透明帽的拉线通过所述中间柔性管相连至所述手柄，所述吻合夹可以装配到所述透明帽内，吻合夹压在拉线上，使得待释放状态的所述吻合夹呈筒状。
  9. 根据权利要求7所述的吻合夹释放装置，其特征在于，所述头端还可以包括推环，所述推环置于所述透明帽内，所述推环与所述透明帽之间由拉线穿过并连接，穿过所述推环和所述透明帽的拉线通过所述中间柔性管相连至所述手柄，所述推环的轴向长度小于所述透明帽，所述吻合夹可以装配到所述透明帽内，其外环形成的不连续的环抵靠在所述推环上，使得待释放状态的所述吻合夹呈筒状。
  10. 根据权利要求9所述的吻合夹释放装置，其特征在于，所述拉线按顺序依次穿过所述推环和所述透明帽将两者相连，且在两者之间形成类Ω型结构。
  11. 根据权利要求9所述的吻合夹释放装置，其特征在于，所述透明帽为其上带有透明帽孔连接孔的双层结构。
  12. 根据权利要求9所述的释放装置，其特征在于，吻合夹套在所述透明帽的靠内侧一层上，其所述外环形成的不连续的环抵靠在所述推环上，且所述内刺的顶端不超出所述透明帽的端部。
  13. 根据权利要求9所述的释放装置，所述连接软帽由弹性材质构成。
  14. 根据权利要求9所述的释放装置，所述中间柔性管沿吻合夹释放装置的轴向设置。
  15. 根据权利要求8所述的释放装置，其特征在于，其拉线的穿线方式为：首先将所述拉线的一端穿入所述透明帽一侧的两个孔，然后将所述拉线的另一端穿过所述透明帽另一侧对称的两个孔，所述拉线合拢之后通过所述中间柔性管连接至所述手柄。
  16. 根据权利要求9所述的释放装置，其特征在于，其拉线的穿线方式为：首先将所述透明帽及所述推环上各自的四个孔分别对齐，随后将所述拉线的一端先顺序穿入所述透明帽的孔及所述推环的孔，再由所述推环的孔及所述透明帽的孔顺序穿出；所述拉线的另一端以同样的方式顺序穿过所述透明帽及所述推环对称的四个孔，所述拉线合拢之后通过所述中间柔性管连接至所述手柄。
  17. 根据权利要求16所述的释放装置，其特征在于装配吻合夹后位于所述透明帽和所述推环之间的所述拉线为类Ω型结构。
  18. 根据权利要求7所述的释放装置，其特征在于内窥镜端部卡在所述释放装置内。
PCT/CN2018/111443 2018-05-17 2018-10-23 消化道自助吻合夹及其释放装置 WO2019218592A1 (zh)

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