WO2016197826A1 - 造口器械 - Google Patents

造口器械 Download PDF

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Publication number
WO2016197826A1
WO2016197826A1 PCT/CN2016/083431 CN2016083431W WO2016197826A1 WO 2016197826 A1 WO2016197826 A1 WO 2016197826A1 CN 2016083431 W CN2016083431 W CN 2016083431W WO 2016197826 A1 WO2016197826 A1 WO 2016197826A1
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WO
WIPO (PCT)
Prior art keywords
cutting
support portion
ostomy
ostomy apparatus
strip
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2016/083431
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English (en)
French (fr)
Inventor
陈文俊
庄少春
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lifetech Scientific Shenzhen Co Ltd
Original Assignee
Lifetech Scientific Shenzhen Co Ltd
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 Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Publication of WO2016197826A1 publication Critical patent/WO2016197826A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B17/295—Forceps for use in minimally invasive surgery combined with cutting implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current

Definitions

  • the present invention relates to the field of medical devices, and in particular to a ostomy device.
  • the venous blood returning from the superior and inferior vena cava to the right atrium enters the right ventricle through the tricuspid valve, and then enters the pulmonary circulation.
  • the rich oxygenated arterial blood after pulmonary oxygen saturation flows into the left atrium through the pulmonary vein.
  • the mitral valve enters the left ventricle and is then supplied to the body through the aorta. Under normal circumstances, the left atrium (or left ventricle) and the right atrium (or right ventricle) are completely isolated from each other by the interatrial septum (or interventricular septum).
  • an opening should be created in the interatrial septum to allow blood in the left and right atrium to communicate, to balance left and right atrial pressure, or to increase blood. Oxygen saturation, thereby prolonging the lives of patients and improving the quality of life. .
  • This procedure for creating an opening in the interatrial septum is called atrial septostomy. Ostomy has been proven to be an effective palliative treatment for the specific patients mentioned above.
  • the compartment opening is substantially expanded by expanding the first opening formed by the interatrial septum to a second opening of a larger size. Due to the resilience of the atrial septal tissue itself, the second opening that is distracted will retain the tendency of rebound recovery. After a period of time, the second opening will shrink or even close.
  • a ostomy bracket is provided in the prior art.
  • the stoma scaffold is a continuous mesh structure, and after being released, it has an intermediate hollow column shape and a horn shape on both sides.
  • the hollow columnar structure serves to support the stoma and keep the blood flow unblocked; the bell mouths on both sides are respectively placed in the left and right atrium to fix the stoma.
  • the stent is pulled out.
  • the stoma scaffold prevents the retraction of the stoma, the incidence of channel embolization and thrombosis increases accordingly after implantation of the stoma scaffold.
  • the presence of the stent makes it difficult to perform the ostomy again.
  • the above-mentioned defects are also present for other tissues such as the stoma of the pericardium, the stomach, and the colon.
  • the present invention provides an ostomy device that prevents tissue retraction at the edge of the stoma without the use of a stoma stent.
  • the present invention provides a ostomy device comprising a cutting device and a grasping device, the cutting device being sleeved on the grasping device, the cutting device comprising a tubular first support portion and a rotatable cutting portion
  • the first support portion is slidably sleeved on the gripping device; the cutting portion is connected to the first support portion; the cutting portion includes at least one cutting unit, and the cutting unit includes a connecting end and a a free end and a connecting member, the connecting end is connected to the first supporting portion, the connecting member is connected between the connecting end and the free end; the connecting member is away from the first supporting portion Extending and radiating radially outward, the connector can be retracted in a direction near the central axis of the first support.
  • the at least one cutting unit comprises a plurality of cutting units, and a plurality of the free ends of the plurality of cutting units are located on the same circumference.
  • the projection of the free end on a cross section perpendicular to the axial direction of the first support portion falls outside the first support portion.
  • the connecting member includes an axial connecting portion and a radial connecting portion smoothly connected to the axial connecting portion; the axial connecting portion is connected to the connecting end and the radial connecting portion And extending along an axial direction of the first supporting portion; the radial connecting portion is connected between the axial connecting portion and the free end, and each of the radial connecting portions is radial Radiation outward.
  • the connecting member has a shape that gradually increases in width from the connecting end toward the free end.
  • the connector is an elastic member.
  • the first support portion includes a first conduit and a second conduit
  • the second conduit is disposed at a distal end of the first support portion and interconnected with the first conduit, at least The second conduit side surface is provided with a strip hole.
  • the strip hole has an angle with a central axis of the first support portion.
  • the number of the strip-shaped holes is plural, forming a plurality of sets of strip-shaped hole groups arranged in sequence, each of the strip-shaped hole groups including at least two of the strip-shaped holes, adjacent to two strips The spacing between the hole groups is set.
  • the strip holes of each of the strip hole groups are juxtaposed in a circumferential direction along the first support portion.
  • the cutting device further includes a first control portion connected between the first control portion and the cutting portion; the first control portion is configured to drive the first portion A support portion rotates, and the rotating first support portion drives the cutting portion to rotate to rotate the cutting portion of the tissue.
  • the cutting unit is a cutting blade.
  • the cutting unit is an electrode probe
  • the first control portion includes a high frequency current generating device that transmits a high frequency current to the electrode probe or a radio frequency transmitting the electrode probe. Radio frequency generating device.
  • the distal end of the grasping device is provided with a clamping portion, and the proximal end of the grasping device is provided with a second control portion.
  • the clamping portion includes two clamping members connected by a pivot, and the second control portion is for controlling the relative opening and closing of the two clamping members.
  • each of the clamping members includes a clamping surface opposite to the other of the clamping members, and each of the clamping surfaces is provided with a plurality of serrated structures.
  • the second control unit is connected to the first rigid cable, and the first rigid cable is connected to the second control portion and connected to two ends of the second control portion.
  • the second rigid cable is connected to one of the clamping members; the second control portion is pushed and pulled, and the first rigid cable and the second rigid cable drive the two clamping members to open and close.
  • the second control portion is a pull ring structure.
  • the ostomy device when the tissue is ostomy, the grasping device firstly positions and grasps part of the tissue to be cut; afterwards, the cutting portion of the cutting device performs part of the tissue grasped by the grasping device.
  • the cut is made, and part of the cut tissue is taken out of the body by the grasping device to form a stoma. That is to say, the stoma formed by the ostomy device is formed by taking a part of the cut tissue out of the body, so that compared with the prior art, the puncture method is used first, and then the reaming method is used.
  • the stoma formed by the ostomy device is not easily retracted.
  • the ostomy device can form a large stoma, thereby further avoiding the defect that the tissue at the edge of the stoma is easily retracted.
  • FIG. 1 is a schematic structural view of a ostomy apparatus according to a first embodiment, the ostomy apparatus including a cutting device and a grasping device;
  • FIG. 2 is a schematic view of the cutting device of FIG. 1, the cutting device includes a cutting portion and a first supporting portion, and the first supporting portion is provided with a strip hole;
  • Figure 3 is a developed view of the strip-shaped hole on the first support portion of the cutting device of Figure 2;
  • Figure 4 is a schematic view showing the structure of the cutting portion of the cutting device of Figure 2, the cutting portion comprising three cutting blades;
  • Figure 5 is a front elevational view of one of the cutting blades of Figure 4.
  • Figure 6 is a side elevational view of one of the cutting blades of Figure 4.
  • FIG. 7A is a schematic structural view of the cutting portion of FIG. 4 housed in the delivery sheath tube;
  • FIG. 7B is a schematic structural view of the cutting portion of FIG. 4 released from the delivery sheath tube;
  • Figure 8 is a schematic view showing the structure of the grasping device of the ostomy apparatus of Figure 1, the grasping device comprising a clamping portion;
  • Figure 9 is a schematic view showing the gripping portion of the gripping device of Figure 8 in an open state
  • Figure 10 is a schematic view showing a portion of the grasping device of the ostomy device
  • Figure 11 is a partial structural view showing a portion of the tissue grasped by the cutting device of the ostomy device
  • FIG. 12 is a schematic structural view of a stoma formed after the ostomy device completes tissue cutting
  • Figure 13 is a schematic structural view of a ostomy device according to a second embodiment
  • Figure 14 is a schematic structural view of the cutting device of the ostomy device shown in Figure 13;
  • Figure 15A is a front elevational view of the cutting portion of the cutting device of Figure 14;
  • Figure 15B is a left side view of the cutting portion of the cutting device of Figure 14;
  • Fig. 16 is a schematic view showing the ostomy device of the second embodiment after the grasping portion is organized and cut.
  • proximal end one end that is relatively close to the operator
  • distal end the end that is relatively far from the operator
  • the ostomy device provided by the present invention can perform the stoma of the atrial septal tissue, the stoma of the pericardial tissue, the stoma of the stomach or the colostomy, etc., and the following is an example of the stoma of the interatrial septum as an example. Ostomy device.
  • FIG. 1 is a schematic structural view of a ostomy apparatus 100 for performing a stoma for atrial septum according to a first embodiment of the present invention.
  • the ostomy appliance 100 includes a hollow cutting device 10 and a grasping device 20 for grasping a portion of the atrial septal tissue that needs to be cut prior to forming a stoma on the interatrial septum.
  • the gripping device 20 is disposed in the cutting device 10.
  • the cutting device 10 includes a first control portion 11, a cutting portion 12, and a first support portion 13 that is tubular and deflectable.
  • the first support portion 13 is disposed between the first control portion 11 and the cutting portion 12 .
  • the first control portion 11 is closer to the operator than the cutting portion 12, and is used to control the first support portion 13 to rotate the cutting portion 12 about the axial direction of the first support portion 13.
  • the first support portion 13 houses a portion of the gripping device 20.
  • the first control portion 11 may include a driving motor connected to the first supporting portion 13, such as a hydraulic driving motor, a pneumatic driving motor, etc., as long as it can control the first supporting portion 13 to drive the cutting portion 12 around the first support.
  • the axial rotation of the portion 13 is sufficient.
  • the first control portion 11 can omit unnecessary.
  • the first support portion 13 includes a first conduit 131 and a second conduit 132.
  • the first duct 131 is located between the first control portion 11 and the second duct 132 for accommodating the partial gripping device 20.
  • the first duct 131 is preferably a spring tube.
  • the second conduit 132 is located between the first conduit 131 and the cutting portion 12.
  • the side surface of the second duct 132 is provided with at least one strip hole 133 for enhancing the curvature of the second duct 132.
  • each of the strip hole groups 130 includes two strip-shaped holes 133 of the same geometric shape uniformly juxtaposed along the circumference of the first support portion 13.
  • the strip-shaped hole 133 has an elongated parallelogram and is at an angle to the central axis of the first support portion 13, for example, 20 degrees, 30 degrees or other angles.
  • the length of the strip hole 133 is preferably limited to one circumference of the first support portion 13 that can be spirally wound.
  • the strip hole 133 is a hollow geometry cut when the tube is laser cut, and the area between the adjacent two strip holes 133 is a tube retained during the laser cutting process.
  • the cutting portion 12 includes three cutting units 14.
  • Each cutting unit 14 includes a connecting end 121, a free end 122, and a connecting member 123 connected between the connecting end 121 and the free end 122.
  • the connecting end 121 is connected to the distal end surface of the first supporting portion 13 .
  • the projection of the free end 122 on the cross section of the first support portion 13 perpendicular to its axial direction falls outside the first support portion 13.
  • the connecting member 123 is elastically retractable radially inwardly, that is, the connecting member is retracted in a direction close to the central axis of the first supporting portion, and includes an axial connecting portion 124 and an axial direction.
  • the connecting section 124 is smoothly connected to the radial connecting section 125.
  • the axial connecting section 124 is connected between the connecting end 121 and the radial connecting section 125 and extends along the axial direction of the first supporting portion 13 .
  • the radial connecting section 125 is coupled between the axial connecting section 124 and the free end 121, and each of the radial connecting sections 125 radiates radially outward.
  • the cutting unit 14 is a cutting blade; and the three free ends 122 of the three cutting units 14 are located on the same circumference; the edge of the free end 122 forms the cutting edge of the cutting unit 14, which can be rotated In the state, the tissue at the target position of the interatrial septum is cut off; the connecting member of the connecting member 123 is an elastic member having a shape gradually increasing in width from the connecting end 121 toward the free end 122, and is smoothly connected with the free end 122; wherein the free end 122 is located in the circumference
  • the upper diameter is 5-10 mm, and the diameter of the stoma formed by cutting by the cutting blade is 5-10 mm.
  • Fig. 7A shows a state in which the cutting blade is elastically retracted into the sheath tube 42;
  • Fig. 7B shows a state in which the cutting blade protrudes from the sheath tube 42 and returns to elastic deformation for atrial septal tissue cutting.
  • the free end 122 has a large width, the contact area between the cutting blade and the interatrial septum is large when the interatrial septum is cut and the interatrial septum is cut, so that the resistance during the rotation of the cutter can be reduced.
  • the shape of the cutting blade can also be other shapes, which is not specifically limited herein.
  • the connecting member 123 of the cutting blade can be disposed in a trapezoidal shape, and the bottom surface of the trapezoidal length is connected to the connecting end 121. The bottom surface of the trapezoidal length is connected to the free end 122.
  • the connecting member 123 when the connecting member 123 is disposed in a trapezoidal shape, the connecting member 123 can also form a corrugated structure along its own extending direction.
  • the connecting member 123 itself is a non-elastic member, it can be realized by the elastic connection of the connecting end 121 and the first supporting portion 13 , and the connecting member 123 faces the center of the first supporting portion 13 under the action of an external force.
  • the direction of the shaft is elastically retracted.
  • the elastic connection can be realized, for example, by providing a spring or other structure between the connection end 121 and the first support portion 13, and is not specifically limited herein.
  • the number of the cutting units 14 may be one, two, four or more, and is not limited to three in the embodiment.
  • the metal pipe is first cut according to a predetermined texture to form a hollow region, and the remaining region is used as a cutting blade; the cutting blade is further shaped by heat treatment to form an axial direction.
  • the cutting blade is made of a material having a shape memory function, such as a nickel titanium alloy or the like.
  • the gripping device 20 includes a clamping portion 22, a second control portion 21, and a tubularly disposed and deflectable second support portion 23.
  • the second support portion 23 is located between the second control portion 21 and the nip portion 22 .
  • the second support portion 23 and the clamped portion 22 in the clamped state are free to pass through the first support portion 13 (as shown in FIG. 1).
  • the clamping portion 22 includes two clamping members 221 connected by a pivot 25 and relatively openable and closable by the second control portion 21.
  • the pivoting member 25 is radially disposed on the second supporting portion 23; the clamping member 221 is sleeved on a portion (not shown) in which the pivot 25 is placed in the second supporting portion 23.
  • Each of the clamping members 221 includes a clamping surface disposed opposite to the other clamping member 221.
  • a plurality of serrated structures 222 are provided on the clamping surface of each of the clamping members 221 for clamping the tissue.
  • a hard wire drawing unit 24 is disposed in the second support portion 23 .
  • the rigid cable pulling unit 24 includes a first rigid wire 241 connected to the second control portion 21 and two second rigid wires 242 separated from one end of the first rigid wire 241 away from the second control portion 21 .
  • the distal end of each of the second rigid wires 242 is connected to a clamping member 221; the second control portion 21 is pushed and pulled, and the rigid cable pulling unit 24 drives the two clamping members 221 to open and close to achieve clamping of the interatrial septum. And loose.
  • the second control portion 21 is a pull ring structure for facilitating the pushing and pulling of the rigid wire drawing unit 24, thereby controlling the opening and closing of the clamping member 221.
  • the first support portion 13 together with the cutting portion 12 is pushed to the right atrium through the delivery sheath 42 by venipuncture; secondly, the second support portion is used.
  • the holding portion 22 is at a suitable position for gripping the space of the interatrial space 41, and the opening and closing clamping portion 22 causes the clamping portion 22 to clamp the tissue of the room partition 41 to be cut; after that, the pushing and cutting portion 12 abuts the desired cutting.
  • the room partition 41 is controlled by the first control unit 11 to control the rotation of the cutting portion 12 by the first support portion 11 to cut the portion of the room spacing 41; after the cutting is completed, the clamping portion 22 is withdrawn and clamped to the two clamping members.
  • the tissue between the 221 is separated from the interatrial septum 41 and taken out to form a septal stoma.
  • the first support portion 13 is withdrawn into the sheath tube 42 to re-squeeze the cutting blade, and the ostomy device 100 is taken out of the body. , complete the surgical procedure.
  • the stoma formed by the ostomy device of the present embodiment is formed by taking out a part of the atrial septal tissue that has been cut out, and therefore, compared with the prior art, the puncture is used first.
  • the stoma formed by the atrial septum device is not easily retracted.
  • the cutting portion is constituted by at least one elastically retractable connecting member that radiates radially outward, it is possible to transport the cutting portion to the inside of the human body with a small sheath when the cutting portion is in an elastically retracted state. The large stoma can be cut when the cutting portion returns to the elastic deformation, so that the defect that the tissue at the edge of the stoma is easily retracted is further avoided.
  • the atrial septostomy appliance 200 of the second embodiment of the present invention is substantially identical to the ostomy appliance 100 and includes a cutting device 10a and a grasping device 22a.
  • the cutting device 10a includes a first control portion 11a, a cutting portion 12a, and a first support portion 13a.
  • the cutting portion 12a includes three cutting units 14a.
  • the ostomy device 200 is different from the ostomy device 100 in that the cutting unit 14a is an electrode probe capable of receiving a high-frequency current, and the first control portion 11a is capable of transmitting a high-frequency current to the electrode probe.
  • High frequency current generating device The three cutting units 14a are circumferentially evenly disposed on the distal end surface of the first support portion 13a.
  • the high-frequency current generating device and the electrode probe are connected by a wire housed in the first support portion 13a.
  • the cutting unit 14a in the present embodiment also includes a connecting end 121a, a connecting member 123a extending axially from the connecting end 121a and expanding radially outward, and a connecting member 123a disposed far away from the connecting member 123a.
  • the connecting member 123a is an elastic member, which can also be elastically retracted under the action of an external force to be transported by a sheath having a smaller inner diameter, and the deformation is restored under the condition of removing an external force to cut a stoma having a larger diameter.
  • the axial connecting section 124a includes an axial connecting section 124a and a radial connecting section 125a that is smoothly connected to the axial connecting section 124a.
  • the axial connecting section 124a is connected between the connecting end 121a and the radial connecting section 125a and extends in the axial direction of the first supporting portion 13a.
  • the radial connecting section 125a is coupled between the axial connecting section 124a and the free end 121a, and each of the radial connecting sections 125a radiates radially outward.
  • the connecting member 123a is a rod-shaped body and is made of a metal having elasticity;
  • the free end 122a is an electrode tip and is fixedly connected to the rod-shaped connecting member 123a by welding or bonding.
  • the electrode tip has a spherical shape to reduce the resistance when it passes through the sheath tube, and the electrode tip is made of a material having good electrical conductivity, such as gold, platinum, or the like.
  • the high-frequency power is passed through a variable frequency transformer device, so that the low-frequency current is converted into a frequency of 400-1000 by frequency conversion and voltage amplification.
  • the voltage is several thousand or even tens of thousands of volts of high frequency current.
  • the principle of high-frequency current cutting tissue is that the electrode probe generates a high thermal effect under the action of high-frequency current, and can cause the cells to expand, burst, and vaporize when in contact with the tissue in the human tissue, thereby achieving the effect of cutting the tissue.
  • the cutting unit 14a can also be an electrode probe that can receive a radio frequency signal.
  • the first control portion 11a is a radio frequency generating device that can transmit a radio frequency signal to the electrode probe, and the radio frequency generating device and the electrode probe The needle is also connected by wires that are accommodated in the first support portion 13a.
  • the principle of the radio frequency cutting is: the radio frequency generating device sends the radio frequency wave to the electrode head through the wire, and after the electrode head contacts the body tissue, the impedance is generated by the tissue itself, so that the water molecules in the target tissue are instantaneously under the action of the radio frequency wave. Oscillating vaporization causes cell rupture to evaporate and achieves a cutting function at its low temperature (40 ° C) constant temperature.
  • the operation method before cutting is the same as that of the first embodiment, except that when cutting is performed, the electrode tip of the electrode probe is first pushed close to and abuts against the interatrial tissue; further controlling the occurrence of high-frequency current
  • the device or the radio frequency generating device
  • the circumference is cut so that the tissue held by the grip portion 22a is separated from the atrial space.
  • the angle of rotation is limited to be able to cut the tissue from the interatrial septum. For this example, when four electrode probes are used, the rotation angle is 90 degrees.
  • the first control portion 11a in this embodiment is not a hollow structure as long as it can pass a wire as a high-frequency current generating device (radio frequency generating device) capable of transmitting a high-frequency current (radio frequency signal) to the electrode probe. That is, at this time, the gripping device 22a is bored in the first support portion 13a of the cutting device 10a.
  • a high-frequency current generating device radio frequency generating device
  • the ostomy apparatus can also oss the other tissues such as the pericardium, the stomach, and the colon.

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Abstract

一种造口器械(100)包括切割装置(10)和抓取装置(20)，切割装置(10)套设在抓取装置(20)上，切割装置(10)包括一个管状的第一支撑部(13)和一个可旋转的切割部(12)，第一支撑部(13)滑动地套设于抓取装置(20)，切割部(12)与第一支撑部(13)相连，切割部(12)包括至少一个切割单元(14)，切割单元(14)包括一个连接端(121)、一个自由端(122)以及一个连接件(123)，连接端(121)与第一支撑部(13)相连，连接件(123)连接于连接端(121)与自由端(122)之间；连接件(123)向远离第一支撑部(13)的方向延伸且径向向外辐射，连接件(123)可向靠近第一支撑部(13)的中心轴的方向回缩。该造口器械(100)对房间隔进行造口时定位简单，造口方便，且造孔口径大，造孔口径周围组织不易回弹。

Description

造口器械
【技术领域】
本发明涉及医疗器械领域，具体地说涉及一种造口器械。
【背景技术】
人体的血液循环系统中，由上、下腔静脉回流至右心房的静脉血经过三尖瓣进入右心室，再进入肺循环，经肺氧饱和后的丰富含氧动脉血经过肺静脉流入左心房，经二尖瓣进入左心室，然后经过主动脉供应全身。正常情况下的左心房（或左心室）与右心房（或右心室）之间依靠房间隔（或室间隔）彼此完全隔离。但是，在某些特定的情况下，例如，对于晚期肺动脉高压患者，需要在房间隔上创造一个开孔，使左、右心房的血液能互通，用来平衡左、右心房压力，或增加血氧饱和，从而延长患者生命，提高生活质量。。这种在房间隔上创造一个开孔的术式，称为房间隔造口术。造口术已经被证实认为是一种有效的姑息治疗方式，用于上述的特定患者。
房间隔造口实质是将房间隔穿刺形成的第一开孔撑开扩大至较大尺寸的第二开孔。由于房间隔组织自身存在回弹性，被撑开的第二开孔会保留着回弹恢复的趋势。经过一段时间以后，第二开孔会缩小甚至闭合。为了解决第二开孔缩小甚至闭合的缺陷，现有技术中提供了一种造口支架。该造口支架为连续型网状结构，释放后呈现中间中空柱状，两侧喇叭形状。该造口支架放置于造口位置且被释放后，中间中空柱状结构起到支撑造口及保持血流畅通的作用；两侧的喇叭口分别置于左、右心房起固定作用，防止造口支架脱出。虽然造口支架阻止了造口的回缩，但是在植入该造口支架后，通道栓塞以及血栓形成的发生机率也相应增加。并且，发生堵塞以后，支架的存在使得再次行造口术变得困难。另外,在造口领域中，对其它组织例如对心包膜、胃部、结肠的造口也存在上述缺陷。
【发明内容】
本发明提供一种无须使用造口支架即可防止造口边缘的组织回缩的造口器械。
本发明提供一种造口器械，包括切割装置及抓取装置，所述切割装置套设于所述抓取装置上,所述切割装置包括一个管状第一支撑部及一个可旋转的切割部，所述第一支撑部滑动地套设于所述抓取装置；所述切割部与所述第一支撑部相连；所述切割部包括至少一个切割单元，所述切割单元包括一个连接端、一个自由端以及一个连接件，所述连接端与所述第一支撑部相连，所述连接件连接于所述连接端与自由端之间；所述连接件向远离所述第一支撑部的方向延伸，且径向向外辐射，所述连接件可向靠近所述第一支撑部中心轴的方向回缩。
在一实施例中，所述至少一个切割单元包括多个切割单元，且多个所述切割单元的多个所述自由端位于同一圆周上。
在一实施例中，所述自由端在所述第一支撑部的垂直于其轴向的横截面上的投影落在所述第一支撑部之外。
在一实施例中，所述连接件包括一个轴向连接段及一个与所述轴向连接段平滑相连的径向连接段；所述轴向连接段连接于所述连接端与径向连接段之间，且沿所述第一支撑部的轴向延伸；所述径向连接段连接于所述轴向连接段与所述自由端之间，且每个所述径向连接段均径向向外辐射。
在一实施例中，所述连接件呈从所述连接端向所述自由端宽度逐渐增大的形状。
在一实施例中，所述连接件为弹性件。
在一实施例中，第一支撑部包括一个第一导管及一个第二导管，所述第二导管设置于所述第一支撑部的远端且与所述第一导管相互连接，至少所述第二导管侧表面设置有条形孔。
在一实施例中，所述条形孔与所述第一支撑部的中心轴存在夹角。
在一实施例中，所述条形孔的数量为多个，形成多组依次排列的条形孔组，每个条形孔组包括至少两个所述条形孔，相邻两个条形孔组之间间隔设置。
在一实施例中，每个所述条形孔组的所述条形孔沿所述第一支撑部周向并列设置。
在一实施例中，所述切割装置还包括一个第一控制部，所述第一支撑部连接于所述第一控制部与切割部之间；所述第一控制部用于驱动所述第一支撑部旋转，旋转的所述第一支撑部带动所述切割部旋转以旋转切割部分所述组织。
在一实施例中，所述切割单元为切割刀片。
在一实施例中，所述切割单元为电极探针，所述第一控制部包括一个向所述电极探针传送高频电流的高频电流发生装置或者一个向所述电极探针传送射频的射频发生装置。
在一实施例中，所述抓取装置的远端设有夹持部，所述抓取装置的近端设有一个第二控制部, 所述夹持部包括两个通过枢轴相连的夹持件，所述第二控制部用于控制两个所述夹持件的相对开合。
在一实施例中，每个所述夹持件均包括一个与另一所述夹持件相对的夹持面，每个所述夹持面上均设置有多个锯齿状结构。
在一实施例中，所述第二控制部连接有第一硬质拉线，所述第一硬质拉线远离所述第二控制部的一端连接有两根第二硬质拉线，每根所述第二硬质拉线与一个所述夹持件相连；推拉所述第二控制部，所述第一硬质拉线以及所述第二硬质拉线带动两个所述夹持件相对开合。
在一实施例中，所述第二控制部为拉环结构。
本发明提供的造口器械在对组织进行造口时，抓取装置先对所需要切割的部分组织进行定位并抓取；之后，切割装置的切割部对抓取装置所抓取的部分组织进行切割，而切割下来的部分组织被抓取装置带出体外，从而形成造口。也就是说，所述造口器械所形成的造口是通过将切割下来的部分组织取出体外而形成的，故，相对于现有技术中先采用穿刺术再采用扩孔方式造口来讲，所述造口器械所形成的造口不易回缩。另外，由于切割部由至少一个径向向外辐射的弹性切割单元构成，造口器械可形成较大的造口，故更加避免了造口边缘的组织容易回缩的缺陷。
【附图说明】
下面将结合附图及实施例对本发明作进一步说明，附图中：
图1为第一实施例提供的造口器械的结构示意图，所述造口器械包括切割装置及抓取装置；
图2为图1中的切割装置示意图, 所述切割装置包括一个切割部及一个第一支撑部，第一支撑部上设有条形孔；
图3为图2中的切割装置的第一支撑部上的条形孔的展开图；
图4为图2中的切割装置的切割部的结构示意图，所述切割部包括三个切割刀片；
图5为图4中一个切割刀片的主视图；
图6为图4中的一个切割刀片的侧视图；
图7A为图4中的切割部容置于输送鞘管中的结构示意图；图7B为图4中的切割部从输送鞘管中释放后的结构示意图；
图8为图1中的造口器械的抓取装置的结构示意图，所述抓取装置包括夹持部；
图9为图8中的抓取装置的夹持部处于打开状态的示意图；
图10为造口器械的抓取装置抓取部分组织的示意图；
图11为造口器械的切割装置切割所述抓取装置所抓取的部分组织的部分结构示意图；
图12为造口器械完成组织切割后所形成的造口的结构示意图；
图13为第二实施例提供的的造口器械的结构示意图；
图14为图13所示造口器械的切割装置的结构示意图；
图15A为图14中的切割装置的切割部的主视图；图15B为图14中的切割装置的切割部的左视图；
图16为第二实施例的造口器械抓取部分组织后并进行切割的示意图。
【具体实施方式】
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。
在介入医疗领域，定义距操作者相对近的一端为近端，距操作者相对远的一端为远端。
本发明提供的造口器械可以进行房间隔组织的造口,心包膜组织的造口，胃部的造口或者结肠造口等,以下就以对房间隔进行造口为例说明本发明提供的造口器械。
第一实施例
图1为本发明第一实施例提供的用于对房间隔进行造口的造口器械100的结构示意图。该造口器械100包括中空的切割装置10以及用于在房间隔上形成造口之前抓取所需要切割的部分房间隔组织的抓取装置20。所述抓取装置20穿设于所述切割装置10中。
请参阅图2，切割装置10包括一个第一控制部11、一个切割部12以及一个呈管状且可偏转的第一支撑部13。所述第一支撑部13设置于第一控制部11与切割部12之间。造口时,所述第一控制部11较切割部12靠近操作者，用于控制第一支撑部13带动切割部12绕第一支撑部13的轴向旋转。所述第一支撑部13收容部分抓取装置20。可以理解的是，第一控制部11可以包括与第一支撑部13相连的驱动马达，例如液压驱动马达、气压驱动马达等，只要其能控制第一支撑部13带动切割部12绕第一支撑部13的轴向旋转即可。当然，还可以理解的是，当操作者手动旋转第一支撑部13时，所述第一控制部11可以省略不要。
请再次参见图1、图2，第一支撑部13包括一个第一导管131及一个第二导管132。第一导管131位于所述第一控制部11及第二导管132之间，用于收容部分抓取装置20。另外，由于第一导管131部分置于人体时所需满足的弯曲性能要求较小,但需具备良好的扭矩传递性能，故，第一导管131优选选用弹簧管。
所述第二导管132位于所述第一导管131及切割部12之间。所述第二导管132侧表面开设有至少一个用于增强第二导管132的弯曲度的条形孔133。
具体的，请一并参见图3，沿着第二导管131侧表面分设有多组依次排列的条形孔组130（参见图中虚线圈示的130部分）。相邻条形孔组130之间间隔设置且不重叠（由竖直的虚线隔开），以实现第二导管132在弯曲的状态下，仍可以保持良好的扭矩传递性能。例如相邻的条形孔组130之间的间距为2mm。每个条形孔组130均包含均匀沿着第一支撑部13周向并列设置的两个几何形状相同的条形孔133。该条形孔133呈狭长的平行四边形，且与第一支撑部13的中心轴存在夹角，例如为20度、30度或其它角度。该条形孔133的长度优选以可螺旋绕设第一支撑部13周向一圈为限。该条形孔133为管材经激光切割时切掉的镂空几何图形，位于相邻的两个条形孔133之间的区域为激光切割过程中保留的管材。
请一并参见图4、图5以及图6，切割部12包括三个切割单元14。每个切割单元14均包括一个连接端121、一个自由端122、一个连接于连接端121与自由端122之间的连接件123。所述连接端121与所述第一支撑部13的远端端面相连。所述自由端122在第一支撑部13的垂直于其轴向的横截面上的投影落在所述第一支撑部13之外。所述连接件123受力可弹性径向向内回缩，即连接件受力可向靠近所述第一支撑部中心轴的方向回缩，其包括一个轴向连接段124及一个与轴向连接段124平滑相连的径向连接段125。所述轴向连接段124连接于所述连接端121与径向连接段125之间，且沿第一支撑部13的轴向延伸。所述径向连接段125连接于所述轴向连接段124与自由端121之间，且每个所述径向连接段125均径向向外辐射。
本实施例中，切割单元14为切割刀片；且三个所述切割单元14的三个所述自由端122位于同一圆周上；自由端122的边缘形成该切割单元14的刃口，能够在旋转状态下切掉房间隔目标位置的组织；连接件123连接件为弹性件，呈从连接端121向自由端122宽度逐渐增大的形状，并与自由端122平滑连接；其中，自由端122所在圆周上的直径为5-10mm，通过该切割刀片切割形成的造口的直径为5-10mm。
需要说明的是,由于连接件123呈从连接端121向自由端122宽度逐渐增大的形状，故，切割刀片可在连接件123处发生弯曲，从而具有较好的收缩和膨胀特性。图7A所示为切割刀片弹性回缩进入至鞘管42内的状态；图7B所示为切割刀片从鞘管42中伸出并恢复弹性形变以进行房间隔组织切割的状态。另外,由于自由端122宽度较大，故，在切割房间隔组织时与房间隔组织时，切割刀片与房间隔组织的接触面积较大，从而可以降低切割刀旋转过程中的阻力。
可以理解的是，切割刀片的形状也可为其它形状，此处并不做具体的限定，例如：切割刀片的连接件123可以呈梯形设置,该梯形长度较短的底面与连接端121相连,该梯形长度较长的底面与自由端122相连。又例如，当采用连接件123为梯形设置时，连接件123还可以沿着其自身的延伸方向形成波纹结构。同时可以理解的是，当连接件123自身为非弹性件时，其可以通过连接端121与第一支撑部13的弹性连接实现，在外力的作用下连接件123朝向靠近第一支撑部13中心轴的的方向弹性回缩。该弹性连接例如可以是通过在连接端121与第一支撑部13之间设置弹簧或者是其他结构来实现的，此处不做具体限定。还可以理解的是，切割单元14的个数也可以为一个、两个、四个或更多个，不限于本实施例中的三个。
同样如图4、图5以及图6所示，形成切割部12时，首先按照预定纹理切割金属管材形成镂空区域，保留下来的区域作为切割刀片；进一步将切割刀片经过热处理定形形成沿着轴向径向向外辐射的切割刀片。优选地，切割刀片为具有形状记忆功能的材料制成，例如镍钛合金等。
请一并参见图8及图9，抓取装置20包括一个夹持部22、一个第二控制部21及一个呈管状设置的且可偏转的第二支撑部23。第二支撑部23位于第二控制部21与夹持部22之间。第二支撑部23以及夹紧状态的夹持部22可在第一支撑部13中自由通过（如图1所示）。
夹持部22包括两个通过枢轴25相连的、可在第二控制部21作用下相对开合的夹持件221。枢轴25径向穿设于第二支撑部23上；夹持件221套设于枢轴25置于第二支撑部23内的部分（未图示）。每个夹持件221均包括与另一夹持件221相对设置的夹持面。每个夹持件221的用于夹持组织的夹持面上均设置有多个锯齿状结构222。
第二支撑部23内设置有硬质拉线单元24。该硬质拉线单元24包括与第二控制部21相连的第一硬质拉线241，以及从第一硬质拉线241远离第二控制部21的一端分设出的两根第二硬质拉线242。每个第二硬质拉线242远端均与一个夹持件221相连；推拉第二控制部21，硬质拉线单元24带动两个夹持件221开合运动，实现对房间隔组织的夹紧以及松开。其中，第二控制部21为拉环结构以方便推拉硬质拉线单元24，从而进行夹持件221开合的控制。
请一并参见图10至12，在进行房间隔造口时，首先，经静脉穿刺，将第一支撑部13连同切割部12经输送鞘管42推送至右心房；其次，将第二支撑部23连同夹持部22从第一支撑部13的内腔中穿过，使夹持部22从第二支撑部23中伸出并靠近房间隔41组织；接着，推拉第二支撑部23使夹持部22处于可夹取房间隔41组织的合适位置，并开合夹持部22使夹持部22夹紧所需切割的房间隔41组织；之后，推送切割部12抵持所需切割的房间隔组织41，通过第一控制部11控制第一支撑部13带动切割部12旋转将部分房间隔41组织切下；切割完成后，撤回夹持部22，将夹持于两个夹持件221之间的组织与房间隔41分离并取出体外形成房间隔造口；最后，回撤第一支撑部13至鞘管42内，使切割刀片重新被挤压收缩，将造口器械100取出体外，完成手术过程。
综上所述，本实施例的所述造口器械所形成的造口是通过将切割下来的部分房间隔组织取出体外而形成的，故，相对于现有技术中先采用穿刺术再采用扩孔方式造口来讲，所述房间隔造口器械所形成的造口不易回缩。另外，由于切割部由至少一个径向向外辐射的可弹性回缩的连接件构成，故既能够在切割部处于弹性回缩状态时用较小的鞘管将切割部输送至人体内部，也可以在切割部恢复弹性形变时切割形成较大的造口，故更加避免了造口边缘的组织容易回缩的缺陷。
第二实施例
如图13至15所示，本发明第二实施例的房间隔造口器械200与造口器械100大体上相同，其包括切割装置10a及抓取装置22a。切割装置10a包括第一控制部11a、切割部12a及第一支撑部13a。切割部12a包括三个切割单元14a。所述造口器械200与造口器械100的不同之处在于，所述切割单元14a为可接收高频电流的电极探针，且第一控制部11a为可向电极探针传送高频电流的高频电流发生装置。所述三个切割单元14a周向均匀地设置于第一支撑部13a远端端面。高频电流发生装置与电极探针通过容设于第一支撑部13a内的导线相连。
与第一实施例的切割单元14相同，本实施例中切割单元14a也包括连接端121a、从连接端121a沿轴向延伸并径向向外扩展的连接件123a，以及设置于连接件123a远端的自由端122a。连接件123a为弹性件，其同样可在外力作用下弹性回缩以利用内径较小的鞘管进行输送，在去除外力的条件下恢复形变，以切割得到较大口径的造口, 其包括一个轴向连接段124a及一个与轴向连接段124a平滑相连的径向连接段125a。所述轴向连接段124a连接于所述连接端121a与径向连接段125a之间，且沿第一支撑部13a的轴向延伸。所述径向连接段125a连接于所述轴向连接段124a与自由端121a之间，且每个所述径向连接段125a均径向向外辐射。不同的是，本实施例中连接件123a为杆状体，且由具有弹性的金属制成；自由端122a为电极头且与杆状的连接件123a通过焊接或者是粘接的方式固定连接。电极头为球形形状，以减小其在鞘管内通过时的阻力，电极头采用具有良好导电性能的材质，如：黄金、铂金等。
具体的，高频电是通过变频变压设备,使低频电流经变频变压、功率放大,转换为频率400-1000 Hz、电压为几千甚至上万伏的高频电流。高频电流切割组织的原理是：电极探针在高频电流的作用下产生高热效应，在人体组织中与组织接触时可使细胞膨胀、爆裂、汽化，从而达到切割组织的效果。
可以理解的是，切割单元14a也可以为可接收射频信号的电极探针，此时相应的，第一控制部11a为可向电极探针传送射频信号的射频发生装置,射频发生装置与电极探针也是通过容设于第一支撑部13a内的导线相连。具体的，射频切割的原理为：由射频发生装置通过导线向由电极头发送射频电波，电极头在接触身体组织后，由组织本身产生阻抗，使目标组织内的水分子在射频电波作用下瞬间振荡汽化，引起细胞破裂蒸发，并在其低温（40℃）恒温状态下实现切割功能。
本实施例中，切割前的操作方法与第一实施例相同，不同之处在于，在进行切割时，首先推送电极探针的电极头靠近并抵持于房间隔组织；进一步控制高频电流发生装置（或者射频发生装置）产生高频电流（或者射频电波），通过第一支撑部13a内部的导线传递至电极头，并施加给组织；之后操控第一控制部11a使电极头旋转一定度数完成圆周切割，使夹持部22a夹持的组织与房间隔分离。其中，旋转的角度以能够将组织从房间隔上切割下来为限。对于本例中，当采用4根电极探针时，旋转角度为90度。
需要说明的是，本实施例中的第一控制部11a并非为中空结构，只要其可以通过导线为可向电极探针传送高频电流（射频信号）的高频电流发生装置（射频发生装置）即可，相应地此时，抓取装置22a穿设于切割装置10a的第一支撑部13a中。
还需要说明的是，本发明所提供的造口器械还可以对其它组织例如对心包膜、胃部、结肠的进行造口。
上面结合附图对本发明的实施例进行了描述，但是本发明并不局限于上述的具体实施方式，上述的具体实施方式仅仅是示意性的，而不是限制性的，本领域的普通技术人员在本发明的启示下，在不脱离本发明宗旨和权利要求所保护的范围情况下，还可做出很多形式，这些均属于本发明的保护之内。

Claims (17)

  1. 一种造口器械，包括切割装置及抓取装置，所述切割装置套设于所述抓取装置上,其特征在于，
    所述切割装置包括一个管状第一支撑部及一个可旋转的切割部，所述第一支撑部滑动地套设于所述抓取装置；所述切割部与所述第一支撑部相连；
    所述切割部包括至少一个切割单元，所述切割单元包括一个连接端、一个自由端以及一个连接件，所述连接端与所述第一支撑部相连，所述连接件连接于所述连接端与自由端之间；所述连接件向远离所述第一支撑部的方向延伸且径向向外辐射，所述连接件可向靠近所述第一支撑部中心轴的方向回缩。
  2. 根据权利要求1所述的造口器械，其特征在于，所述至少一个切割单元包括多个切割单元，且多个所述切割单元的多个所述自由端位于同一圆周上。
  3. 根据权利要求1所述的造口器械，其特征在于，所述自由端在所述第一支撑部的垂直于其轴向的横截面上的投影落在所述第一支撑部之外。
  4. 根据权利要求1所述的造口器械，其特征在于，所述连接件包括一个轴向连接段及一个与所述轴向连接段平滑相连的径向连接段；所述轴向连接段连接于所述连接端与径向连接段之间，且沿所述第一支撑部的轴向延伸；所述径向连接段连接于所述轴向连接段与所述自由端之间，且每个所述径向连接段均径向向外辐射。
  5. 根据权利要求1所述的造口器械，其特征在于，所述连接件呈从所述连接端向所述自由端宽度逐渐增大的形状。
  6. 根据权利要求1至5任一项所述的造口器械，其特征在于，所述连接件为弹性件。
  7. 根据权利要求1至5任一项所述的造口器械，其特征在于，第一支撑部包括一个第一导管及一个第二导管，所述第二导管设置于所述第一支撑部的远端且与所述第一导管相互连接，至少所述第二导管侧表面设置有条形孔。
  8. 根据权利要求7所述的造口器械，其特征在于，所述条形孔与所述第一支撑部的中心轴存在夹角。
  9. 根据权利要求8所述的造口器械，其特征在于，所述条形孔的数量为多个，形成多组依次排列的条形孔组，每个条形孔组包括至少两个所述条形孔，相邻两个条形孔组之间间隔设置。
  10. 根据权利要求9所述的造口器械，其特征在于，每个所述条形孔组的所述条形孔沿所述第一支撑部周向并列设置。
  11. 根据权利要求1-5任一项所述的造口器械，其特征在于，所述切割装置还包括一个第一控制部，所述第一支撑部连接于所述第一控制部与切割部之间；所述第一控制部用于驱动所述第一支撑部旋转，旋转的所述第一支撑部带动所述切割部旋转以旋转切割部分所述组织。
  12. 根据权利要求10所述的造口器械，其特征在于，所述切割单元为切割刀片。
  13. 根据权利要求10所述的造口器械，其特征在于，所述切割单元为电极探针，所述第一控制部包括一个向所述电极探针传送高频电流的高频电流发生装置或者一个向所述电极探针传送射频的射频发生装置。
  14. 根据权利要求1-5任一项所述的造口器械，其特征在于，所述抓取装置的远端设有夹持部，所述抓取装置的近端设有一个第二控制部, 所述夹持部包括两个通过枢轴相连的夹持件，所述第二控制部用于控制两个所述夹持件的相对开合。
  15. 根据权利要求14所述的造口器械，其特征在于，每个所述夹持件均包括一个与另一所述夹持件相对的夹持面，每个所述夹持面上均设置有多个锯齿状结构。
  16. 根据权利要求14所述的造口器械，其特征在于，所述第二控制部连接有第一硬质拉线，所述第一硬质拉线远离所述第二控制部的一端连接有两根第二硬质拉线，每根所述第二硬质拉线与一个所述夹持件相连；推拉所述第二控制部，所述第一硬质拉线以及所述第二硬质拉线带动两个所述夹持件相对开合。
  17. 根据权利要求14所述的造口器械，其特征在于，所述第二控制部为拉环结构。
PCT/CN2016/083431 2015-06-12 2016-05-26 造口器械 Ceased WO2016197826A1 (zh)

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