WO2018045796A1 - 造口器械 - Google Patents

造口器械 Download PDF

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Publication number
WO2018045796A1
WO2018045796A1 PCT/CN2017/090593 CN2017090593W WO2018045796A1 WO 2018045796 A1 WO2018045796 A1 WO 2018045796A1 CN 2017090593 W CN2017090593 W CN 2017090593W WO 2018045796 A1 WO2018045796 A1 WO 2018045796A1
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WO
WIPO (PCT)
Prior art keywords
ostomy
tube
cutting
ring
connecting member
Prior art date
Application number
PCT/CN2017/090593
Other languages
English (en)
French (fr)
Inventor
庄少春
刘鹏
曾莉群
Original Assignee
先健科技(深圳)有限公司
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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 WO2018045796A1 publication Critical patent/WO2018045796A1/zh

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Classifications

    • 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
    • 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
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • 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
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/1815—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using microwaves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • 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
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1442—Probes having pivoting end effectors, e.g. forceps
    • A61B2018/1452—Probes having pivoting end effectors, e.g. forceps including means for cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/007—Aspiration

Definitions

  • the invention relates to the field of medical devices, and in particular to a ostomy device.
  • the left atrium (or the left ventricle) and the right atrium (or the right ventricle) are normally completely isolated from each other by the interatrial septum (or interventricular septum), but in some special cases, for example, For patients with advanced pulmonary hypertension or heart failure, openings should be placed 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 patient life. ,improve the quality of life.
  • This method of opening an opening in the interatrial septum is called atrial septostomy. Ostomy is not only suitable for atrial septum, but also for other tissues, such as the pericardium, the tissue wall of the stomach, or the tissue wall of the colon.
  • the commonly used atrial septostomy is to first form a small aperture opening in the interatrial septum, and then expand the opening (for example, using balloon expansion) to form a larger aperture. Since the atrial septal tissue itself has resilience, the opening after the expansion has a tendency to recover from rebound, and after the completion of the stoma, the opening will gradually shrink or even close. Once the tissue is closed, the ostomy fails, and the ostomy again will not only increase the damage of the patient, but also make the implementation more difficult. Therefore, it is necessary to provide a ostomy device that avoids significant retraction of the tissue opening.
  • the ostomy device provided by the technical solution includes a grasping device and a cutting device, the grasping device includes a first tube body and a negative pressure source, and the negative pressure source is in communication with a lumen of the first tube body;
  • the cutting device includes a cutting portion that surrounds a distal end opening of the first tubular body, and the cutting portion is movable relative to the first tubular body.
  • the cutting device may further include a second tube body and a connecting member, the connecting member being movably disposed in the second tube body and connected to the cutting portion.
  • the cutting portion moves relative to the first tubular body in a radial direction under the driving of the connecting member.
  • the cutting portion includes a ring electrode; the ring electrode surrounds a distal end of the first tube and is coupled to the connector.
  • the connector and the ring electrode are respectively different portions of the same wire.
  • the ring electrode includes at least one turn opening or a closed metal ring.
  • the cutting device may further include a third tube body and a wire movably disposed in the third tube body, the wire drawing being connected to the ring electrode on an opposite side of the connecting member .
  • the cutting portion is axially moved relative to the first tubular body under the drive of the connector.
  • the cutting portion includes a ring electrode
  • the connecting member includes a connecting tube coaxial with the ring electrode, the ring electrode is connected to one end of the connecting tube, and is sleeved together Said on the first tube.
  • the connector further includes a support structure coaxial with the connecting tube, the ring electrode being coupled to the connecting tube by the support structure.
  • the cutting device further includes an energy source electrically coupled to the cutting portion.
  • the energy source may be selected from at least one of a radio frequency source and a microwave source.
  • the ostomy appliance further includes a catheter, the first tubular body and the second tubular body being juxtaposed within the catheter.
  • the ostomy appliance further includes a collection device in communication with the lumen of the first tubular body.
  • the ostomy device of the present technical solution is used for the atrial septal ostomy, and the atrial septal tissue to be cut and separated is directly moved under the negative air pressure in the lumen of the first tubular body and finally withdrawn from the body. Can avoid secondary damage during surgery.
  • the opening formed by the ostomy apparatus of the present invention is formed by tissue cutting removal, so that once the opening is formed, the tissue does not have a significant retraction, the opening topography or contour is stabilized, and the ostomy operation can be successful once.
  • FIG. 1 is a schematic structural view of a ostomy apparatus according to a first embodiment of the present invention
  • Figure 2 is a side elevational view of the ostomy device of Figure 1 pointing from the distal end to the proximal end;
  • Figure 3 is a schematic view of the cutting portion and the connecting member of the ostomy device of Figure 1;
  • FIG. 4A-4C are schematic views showing the operation of the ostomy using the ostomy apparatus of FIG. 1;
  • Figure 5 is a schematic structural view of a ostomy apparatus according to a second embodiment of the present invention.
  • Figure 6 is a side elevational view of the ostomy device of Figure 5 from the distal end to the proximal end;
  • Figure 7 is a schematic view showing a portion of the ring electrode of the ostomy device of Figure 5 housed in the second tube;
  • Figure 8 is a schematic structural view of a cutting device for a ostomy apparatus according to a third embodiment of the present invention.
  • Figure 9 is a partial structural view of a ostomy apparatus according to a fourth embodiment of the present invention.
  • Figure 10 is a partial structural view showing a ostomy apparatus according to a fifth embodiment of the present invention.
  • Figure 11 is a side elevational view of the ostomy appliance of Figure 10 pointing from the distal end to the proximal end.
  • the embodiments of the present invention are described in detail with reference to the accompanying drawings.
  • the end that is relatively close to the operator is defined as the proximal end
  • the end that is relatively far from the operator is the distal end.
  • the ostomy apparatus can perform a stoma of atrial septal tissue, a stoma of a pericardial tissue, a stoma of the stomach, or a colostomy, etc.
  • the present invention is intended to be illustrative only and not limiting of the invention, and any solution based on the teachings of the present invention is within the scope of the present invention.
  • the ostomy apparatus includes a grasping device and a cutting device, and the grasping device can suck the atrial septal tissue to be cut by the negative air pressure, and the cutting device then cuts and removes the sucked tissue, thereby being on the interatrial septum. An opening is formed.
  • the amount of the sucked tissue can be controlled by adjusting the magnitude of the negative air pressure and the length of time for supplying the negative air pressure. The more the amount of tissue to be inhaled, the more the tissue to be cut and removed, the larger the aperture of the opening formed by the stoma, and vice versa. Also.
  • the opening formed by the stoma is formed without secondary expansion and is only related to the amount of tissue removed by the cutting, so the opening does not gradually become smaller due to tissue retraction after surgery. Even after closure, the opening is stable after surgery.
  • a ostomy appliance 1 in accordance with a first embodiment of the present invention includes a grasping device, a cutting device, and a catheter 13.
  • the catheter 13 includes a tubular structure having a distal end face 13a, a proximal end face 13b, and an axial direction 13c. In operation, a portion of the catheter 13 adjacent the proximal end is external to the body and a portion adjacent the distal end extends into the body.
  • the catheter 13 can be divided in the axial direction 13c into a distal portion 131, a proximal portion 132, and an intermediate portion 133 between the distal portion 131 and the proximal portion 132, the proximal portion 132 being in operation It is always outside the body, and its outer diameter may be longer than the outer diameter of the intermediate portion 133 and the outer diameter of the distal portion 131.
  • the smaller outer diameter of the distal portion 131 facilitates the passage of the catheter 13 into the body to perform an ostomy.
  • the outer diameter of the distal end portion 131 may be slightly longer than the outer diameter of the intermediate portion 133, which is advantageous for facilitating recovery of the cut and separated tissue during the ostomy.
  • a developing structure (not shown) is also provided adjacent the distal end of the catheter 13, and any suitable developing structure known in the art, such as a developing ring, or a developing block, or the like can be employed.
  • a developing ring as an example, it is embedded in the distal wall of the catheter 13, and may be formed of a metal material such as gold, platinum-rhodium alloy, or tantalum.
  • the visualization structure is provided, and it is convenient to operate the catheter 13 into the right atrium during the ostomy, and combined with the ultrasound imaging device, the distal end surface 13a of the catheter 13 is facilitated to form a housing spacer structure to start the ostomy operation.
  • the grasping device includes a first tube body 111 and a negative pressure source 112, and the negative pressure source 112 is in communication with the lumen of the first tube body 111.
  • the first tube body 111 is disposed in the conduit 13 and coaxial with the tubular structure of the conduit 13, i.e., each has an axial direction 13c.
  • the inner diameter of the first tubular body 111 in the axial direction 13c can be aligned with the outer diameter of the conduit 13 in the axial direction 13c.
  • the inner diameter of the proximal end portion of the first tubular body 111 can be longer than the intermediate portion.
  • the inner diameter is long and the inner diameter of the distal end portion is long, and the inner diameter of the distal end portion is slightly longer than the inner diameter of the intermediate portion.
  • the proximal end of the first tubular body 111 communicates with the negative pressure source 112, so that the air pressure in the first tubular body 111 can be controlled by the negative pressure source 112, for example, a negative air pressure can be formed in the first tubular body 111 by drawing a negative pressure.
  • the distal end surface of the first tube 111 is flush with the distal end surface 13a of the catheter 13, or protrudes from the distal end surface 13a of the catheter 13.
  • the first tube body 111 has a circular or nearly circular diameter section, and its shape determines the shape of the opening formed by the ostomy, that is, the shape of the formed opening is substantially the same as that of the first tube 111. , round or nearly circular.
  • the inner diameter of the first pipe body 111 is usually slightly longer than the diameter of the opening formed by the to-be-formed port.
  • the inner diameter of the first pipe body 111 may be 2 to 8 mm, or may be 2 to 5 mm, or 3 to 4 mm, or 7 to 8 mm.
  • the cutting device includes a cutting portion 121, a second tube body 122, and a connecting member 123.
  • the second tubular body 122 is disposed within the conduit 13 and coaxial with the tubular structure of the conduit 13, i.e., each having an axial direction 13c.
  • the first tube body 111 and the second tube body 122 are arranged side by side, for example, may be arranged side by side in parallel, and generally do not communicate with each other.
  • the distal end surface of the second tubular body 122 does not exceed the distal end surface 13a of the catheter 13.
  • the second tube body 122 has a circular or nearly circular diameter section, and may be, for example, an elliptical shape.
  • the connecting member 123 is movably disposed in the second tubular body 122.
  • the distal end of the connecting member 123 is connected to the cutting portion 121.
  • the proximal end of the connecting member 123 is connected to a driving device outside the catheter 13 (not shown).
  • the driving device Under the action of the driving device, the connecting member 123 can move in the axial direction 13c in the second tubular body 122, thereby driving the distally connected cutting portion 121 to move.
  • the cutting portion 121 can be moved into the second tube body 122 under the driving action of the connecting member 123, so that at least a portion of the cutting portion 121 is received in the second tube body 122; otherwise, the cutting portion 121 can also be in the connecting member 123.
  • the drive is released from the second tube 122.
  • the connecting member 123 is a connecting rod
  • the diameter cross-sectional shape of the connecting rod is the same as or similar to the radial cross-sectional shape of the second tubular body 122, for example, may be elliptical, and the diameter of the connecting rod is long. Slightly smaller than the inner diameter of the corresponding diameter section of the second pipe body 122, the connecting rod is not easy to rotate in the second pipe body 122, and is not easy to rotate relative to the second pipe body 122 in the radial direction and the circumferential direction. It is possible to reduce the displacement of the cutting portion 121 connected to the connecting rod.
  • the connecting rod can be made of a conductive metal, for example, a metal material such as nickel-titanium alloy, stainless steel or copper. Therefore, the cutting portion 121 can be directly electrically connected to the connecting rod, for example, by welding or metal sleeve.
  • the connecting rod may be a hollow tube body having a wire provided therein, and the cutting portion 121 is electrically connected to the wire.
  • the cutting portion 121 surrounds the distal end opening of the first tubular body 111, and the cutting portion is movable relative to the first tubular body. For example, the cutting portion 121 can move radially or axially relative to the first tubular body 111.
  • the cutting portion 121 includes a ring electrode 121a and a connecting portion 121b.
  • the ring electrode 121a is electrically connected to the connecting portion 121b, and the ring electrode 121a surrounds the distal opening of the first tube 111, and the connecting portion 121b is connected to the connecting member 123, for example, direct electricity. connection.
  • the ring electrode 121a and the connecting segment 121b may be made of the same material, for example, both of which may be made of a conductive elastic metal material, which may be any suitable metal material such as nickel titanium alloy, stainless steel or copper.
  • the ring electrode 121a is radially compressed by an external force and returns to an initial state after the external force is removed.
  • the ring electrode 121a includes at least one open or closed metal ring, and a closed metal ring is shown in the figure.
  • the metal ring surrounds the first tube 111 on the distal end side of the distal end surface of the first tube 111.
  • the metal ring may be circular or approximately circular, and may be, for example, an ellipse having a diameter that is greater than a corresponding path length of the distal opening of the first tubular body 111 so as to surround the distal opening.
  • a V-shaped projection 121c may be formed on the ring electrode 121a.
  • a connecting rod 123 (followed by reference numeral 123) is located in the second tubular body 122 and coaxial with the catheter 13, i.e., has an axial direction 13c; the annular electrode 121a is located at the distal end of the catheter 13.
  • the distal end side of the end surface 13a is non-parallelly connected with the connecting rod, and an angle a is formed between the two, a is greater than 0° and less than 180°, for example, the angle a may be between 30° and 120°, or At 30 ° ⁇ 90 °, the angle a in the figure is 90 °.
  • the connecting rod 123 can move in the axial direction 13c in the second tubular body 122 under the action of the driving device, for example, can move in the proximal direction along the axial direction 13c, thereby driving the ring electrode 121a to move in the direction of the cutting axial direction 13c.
  • the direction of the cutting axial direction 13c is non-parallel to the direction of the axial direction 13c, so that the annular electrode 121a is finally received in the second tubular body 122.
  • the movement defining the above-described cutting axial direction 13c is a radial movement with respect to the first tubular body 111.
  • the connecting rod 123 can also move in the distal direction in the axial direction 13c, thereby gradually pushing the ring electrode 121a received in the second tube body 122 out of the second tube body 122, and returning to the initial shape, that is, sandwiching the connecting rod 123. Angle a.
  • the cutting device also includes an energy source 124 that is electrically coupled to the cutting portion 121 to provide the cutting portion 121 with an energy source for cutting tissue.
  • the energy source 124 can include a radio frequency source, a microwave source, and the like.
  • the radio frequency source is used, so that the cutting portion 121 can remove the interatrial septal tissue grasped by the grasping device by radio frequency ablation.
  • the RF source outputs a high frequency electrical signal, and the operating frequency of the high frequency generator is 300 kHz to 5 MHz.
  • the frequency range is 400 kHz to 1000. kHz; the output power of the high frequency generator is not more than 300w, and preferably, the power range is 50 ⁇ 100w.
  • the ostomy appliance 1 further includes a collection device coupled to the lumen of the first tubular body 111 and integrated with a source of negative pressure.
  • the collecting device collects blood drawn through the negative air pressure of the first tube 111 and cuts the separated atrial septal tissue by a negative pressure generated by a negative pressure source during the surgery.
  • FIG. 4A-4C illustrate the operation of the ostomy apparatus 1 row ostomy according to the present embodiment.
  • the existing conventional method is used to establish a vascular interventional path of the femoral vein to the right atrium using a guide wire
  • the delivery sheath 10 is delivered to the right atrium
  • the catheter 13 is pushed into the delivery sheath 10 and along the delivery sheath. 10 reached the right atrium.
  • the ring electrode 121a is located on the distal end side of the catheter 13, and the distal opening of the first tube 111 is completely surrounded by the ring electrode 121a.
  • the catheter 13 is continued to be pushed until the distal end surface 13a of the catheter 13 abuts the interatrial septum 100, which may be a fossa oval.
  • the negative pressure source 112 is activated to draw a negative pressure on the first tube 111 to form a negative air pressure in the first tube 111.
  • the distal opening of the first tube 111 is abutted.
  • the inter-apartment space 100 of the end face will be sucked and fixedly attached to the first tube body 111.
  • the ring-shaped electrode 121a that surrounds the distal end of the first tube body 111 surrounds a portion of the room space 100 that is sucked.
  • the magnitude of the negative air pressure may be appropriately adjusted so that the first tube body 111 can absorb the fixed interatrial space 100 while further sucking a part of the tissue of the interatrial septum 100 into the tube of the first tube body 111.
  • the amount of atrial septal tissue inhaled into the lumen of the first tubular body 111 is related to the length of time during which the negative air pressure is supplied and the magnitude of the negative air pressure.
  • the ring electrode 121a contacts the interatrial septum 100 during exercise and tightens the interatrial septum 100.
  • the radioactive source is electrically connected to the ring electrode 121a.
  • the ring electrode 121a radio abuts the interatrial septum 100 while tightening the interatrial septum 100.
  • the atrial septal tissue that has been sucked by the first tubular body 111 is cut away from the interatrial septum 100.
  • the continuous drive link 123 is moved proximally to cause the ring electrode 121a to cut the atrial septum tissue 100 until the ring electrode 121a completely separates the surrounding atrial septal tissue from the interatrial septum 100.
  • the part of the atrial septal tissue separated from the interatrial septum 100 is sucked by the first tubular body 111 by the negative air pressure and accommodated in the first tubular body 111. Once completely separated from the interatrial septum 100, it is immediately driven by the negative air pressure.
  • the proximal end of a tube 111 is moved and finally removed from the first tube 111 and withdrawn from the body, for example, after being withdrawn from the body and stored in a collection device.
  • an opening 100a is formed in the interatrial septum 100, the topography or contour of the opening 100a is consistent with the topography of the distal opening of the first tubular body 111, and the size (ie, the diameter) of the opening 100a is
  • the amount of atrial septal tissue that is drawn into the lumen by the first tubular body 111 is related to the amount of tissue inhaled, indicating that the more tissue to be removed and removed, the more the amount of tissue removed by cutting, at the interatrial septum 100
  • the larger the opening formed by the cutting the person skilled in the art can select the appropriate amount of cutting tissue according to the specific situation. For example, an opening 100a of 5 to 10 mm can generally be cut at the interatrial septum 100.
  • the atrial septal tissue to be cut and separated is inhaled into the lumen by the first tubular body and fixed in the lumen before cutting, so this part of the tissue After being cut, it does not enter the blood circulation system, but directly moves to the proximal end in the lumen of the first tube under the action of negative air pressure and finally withdraws from the body, thereby avoiding secondary injury during the operation.
  • the present invention adopts a cutting portion to tighten the atrial septal tissue and cut and cut the tissue by radio frequency ablation cutting
  • the cutting structure is simple, for example, a ring electrode can be used; and the operation is simple, and only the driving portion can be driven to move, so the cutting operation is performed.
  • Radiofrequency ablation cutting is used, and the edge of the opening is ablated and hemostasis at the same time as the cutting is completed, further reducing the amount of bleeding.
  • the opening formed by the ostomy apparatus of the present invention is formed by tissue cutting removal, and is not formed by expansion of the small hole expansion, so that once the opening is formed, the tissue does not have significant retraction, and the opening edge has been radiofrequency ablated. Coking" further prevents the tissue from retracting, whereby the opening shape or contour formed by the stoma is stable, and the stoma operation can be successful once.
  • the difference from the first embodiment is that the cutting device of the ostomy apparatus 2 according to the second embodiment of the present invention further includes a third tube (not shown) and is movably disposed. Drawing 24 in the third tube.
  • the third pipe body is disposed in the conduit 23 and coaxial with the pipe body of the pipe 23.
  • the third pipe body is arranged side by side with the first pipe body 211 and the second pipe body 222, for example, may be arranged side by side in parallel, generally not connected to each other.
  • the distal end of the third tubular body may be open on the wall of the catheter 23, for example, an opening may be formed in the vicinity of the distal portion of the intermediate portion of the catheter 23.
  • the diameter of the third pipe body is circular or approximately circular.
  • the proximal end of the wire 24 extends from the third tube body and is coupled to a driving device (not shown) so as to be axially movable in the third tube body by a driving means (not shown).
  • the distal end of the wire drawing 24 extends from the third tube body to the ring electrode 221a, the connection portion is located on the opposite side of the connector, and is also connectable at the V-shaped projection 221c of the ring electrode 221a.
  • the wire 24 is axially movable toward the proximal end under driving to pull the ring electrode 221a toward the proximal end such that the ring electrode 221a abuts the distal end surface 23a of the catheter 23 to surround the distal opening of the first tube body 211, or A portion of the ring electrode 221a is sleeved on the conduit 23 to surround the entire distal end face 23a, so that on the one hand, the ring electrode 221a can be stabilized during operation to avoid displacement thereof, and on the other hand, the ring electrode 221a can be completely surrounded.
  • the distal end of a tubular body 211 is open.
  • the wire 24 can be detachably coupled to the ring electrode 221a. When the interatrial septum is grasped and completely surrounded by the ring electrode 221a, the wire 24 can be released from the ring electrode 221a to withdraw the third tube. Referring to Fig. 7, the wire 24 can also be fixedly coupled to the ring electrode 221a. When the connecting rod moves toward the proximal end to drive the ring electrode 221a to move radially to cut the tissue, the wire 24 is driven to move toward the proximal end without affecting the cutting tissue.
  • the difference from the first embodiment is that, in the cutting device 32 of the ostomy apparatus according to the third embodiment of the present invention, the ring electrode and the connecting member 323 of the cutting portion 321 are respectively different portions of the same wire.
  • the ring electrode 321 is still located on the distal end side of the first tube body, and the connecting member 323 is still movably disposed in the second tube body.
  • the wire is elastic and has electrical conductivity, and may be made of any suitable metal material such as nickel titanium alloy, stainless steel or copper.
  • the ring electrode 321 is integrally formed with the connecting member 323, and there is no need for additional connection between the two, such as welding, and no third-party connecting members, such as a metal sleeve, so that the connection between the two is highly reliable. It is not easy to break during the movement of the drive link 323.
  • the ring electrode 321 can be electrically connected to the energy source directly through the connecting member 323, and no other wires are needed, which further simplifies the structure.
  • the difference from the first embodiment is that the distal end faces of the first tube body 411 and the second tube body 422 of the ostomy apparatus according to the fourth embodiment of the present invention are not different from the distal end of the catheter 43.
  • the end surface 43a is flush, but protrudes from a distal end surface 43a of the duct 43.
  • the ring electrode 421a is sleeved on the first tube body 411 so that the first tube body 411 is completely surrounded, thereby completely surrounding the distal opening of the first tube body 411.
  • the connector is pushed in the distal direction to move the ring electrode 421a toward the distal end to surround the grasped atrial septal tissue, so that cutting and recycling of the tissue can be performed.
  • the ring electrode 421a realizes the distal opening around the first tube body 411 by enclosing the first tube body 411, so the ring electrode does not block the distal opening of the first tube body 411, and can ensure complete encirclement Grab the interatrial tissue for easy subsequent cutting.
  • the difference from the first embodiment is that the cutting portion 521 of the ostomy apparatus 5 according to the fifth embodiment of the present invention can be axially opposed to the first tube 511 by the driving of the connecting tube 523. motion.
  • the second pipe body (not shown) has a larger diameter than the first pipe body 511 and is sleeved on the first pipe body 511 and coaxial with the first pipe body 511.
  • the cutting portion 521 includes a ring electrode 521a
  • the connecting member 523 includes a connecting tube coaxial with the ring electrode 521a (hereinafter indicated by reference numeral 523).
  • the connecting tube 523 is movably disposed in the second tube body, and the ring electrode 521a is One end of the connecting tube 523 is connected, that is, connected to the distal end of the connecting tube 523, and is sleeved on the first tube body 511.
  • the connecting tube 523 is integrated with the second tube body.
  • the cutting portion 521 further includes a support structure 521b coaxial with the connecting tube 523, and the ring electrode 521a is connected to the connecting tube 523 through the supporting structure 521b.
  • the diameter of the ring electrode 521a is smaller than the diameter of the connecting tube 523 and the supporting structure 521b, and the diameter of the ring electrode 521a is slightly larger than the diameter of the first tube 511.
  • the support structure 521b may take any suitable structure, for example, may include a ring of Z-shaped waves 521c arranged in the circumferential direction.
  • the driving connection tube 523 is distally located in the second tube body.
  • the ring electrode 521a connected to the connecting tube 523 will eventually contact and compress the atrial septal tissue during the movement, and perform radiofrequency ablation of the surrounding atrial septal tissue. , cutting it apart from the interatrial septum to form an opening.
  • the tissue to be cut is sucked by the first pipe body 511 by the negative air pressure to prevent the cutting and separating from falling off, and can be moved to the proximal end in the first pipe body 511 immediately after the cutting and separating.
  • the connecting tube 523 together with the ring electrode 521a can further prevent the cut tissue from entering the blood circulation system again, assuming that the tissue is not sucked into the first tube 511 in time after cutting.
  • the connecting tube 523 can also block this part of the tissue from entering the blood circulation system, further reducing the intraoperative risk.
  • the interatrial septum to be cut is inhaled into the lumen by the first tube and fixed in the lumen before cutting, so this part After being cut, the tissue does not enter the blood circulation system, but moves directly in the lumen of the first tube under the action of negative air pressure and finally withdraws from the body, thereby avoiding secondary injury during the operation.

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Abstract

一种造口器械（1），包括抓取装置和切割装置。抓取装置包括第一管体（111）和负压源（112），负压源（112）与第一管体（111）的管腔连通；切割装置包括切割部（121），切割部（121）环绕第一管体（111）的远端开口，且切割部（121）与第一管体（111）可相对运动。采用该造口器械（1）可在组织上形成形貌或轮廓稳定的开口，可避免开口明显回缩。

Description

造口器械
【技术领域】
本发明涉及医疗器械领域，尤其涉及一种造口器械。
【背景技术】
人体的血液循环系统中，正常情况下左心房（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，在某些特殊情况下，例如，对于晚期肺动脉高压患者或心力衰竭患者来说，需在房间隔上开设开孔，使左、右心房的血液能互通，用以平衡左、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。这种在房间隔上开设开口的方法，称为房间隔造口术。造口术不仅适用于房间隔，还适用于其它组织，例如心包膜、胃部的组织壁、或结肠的组织壁等。
目前，常用的房间隔造口术是先将房间隔穿刺形成一孔径较小的开孔，随后对该开孔扩张（例如采用球囊扩张）撑开后形成孔径较大的开孔。由于房间隔组织自身存在回弹性，撑开后的开孔具有回弹恢复的趋势，造口完成后，该开孔将逐渐缩小甚至闭合。组织一旦闭合，本次造口术失效，再次行造口术不仅将增加患者的伤害，且实施难度更高。因此，有必要提供一种可避免组织开口明显回缩的造口器械。
【发明内容】
本技术方案提供的造口器械包括抓取装置和切割装置，所述抓取装置包括第一管体和负压源，所述负压源与所述第一管体的管腔连通；所述切割装置包括切割部，所述切割部环绕所述第一管体的远端开口，且所述切割部与所述第一管体可相对运动。
在一个实施例中，所述切割装置还可包括第二管体和连接件，所述连接件可动地设于所述第二管体内并与所述切割部相连。所述切割部在所述连接件的驱动下与所述第一管体相对径向运动。
在一个实施例中，所述切割部包括环形电极；所述环形电极环绕所述第一管体的远端开口，并与所述连接件相连。
在一个实施例中，所述连接件和所述环形电极分别为同一金属丝的不同部分。
在一个实施例中，所述环形电极包括至少一圈开口或闭合金属环。
在一个实施例中，所述切割装置还可以包括第三管体和可动地设于所述第三管体内的拉丝，所述拉丝在所述连接件的相对一侧与所述环形电极连接。
在一个实施例中，所述切割部在所述连接件的驱动下与所述第一管体相对轴向运动。
在一个实施例中，所述切割部包括环形电极，所述连接件包括与所述环形电极同轴的连接管，所述环形电极与所述连接管的一端相连，且一并套设于所述第一管体上。
在一个实施例中，所述连接件还包括与所述连接管同轴的支撑结构，所述环形电极通过所述支撑结构与所述连接管相连。
在一个实施例中，所述切割装置还包括能量源，所述能量源与所述切割部电连接。所述能量源可以选自射频源、微波源中的至少一种。
在一个实施例中，所述造口器械还包括导管，所述第一管体和第二管体并列地设于所述导管内。
在一个实施例中，所述造口器械还包括收集装置，所述收集装置与所述第一管体的管腔连通。
采用本技术方案的造口器械对房间隔行造口术，待切割分离的房间隔组织被切割后直接在负气压作用下在第一管体的管腔内朝近端移动并最终撤出体内，可避免术中产生二次伤害。并且，通过本发明的造口器械形成的开口由组织切割去除形成，因此开口一旦形成则组织不会有明显的回缩，开口形貌或轮廓稳定，造口操作可一次成功。
【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是本发明第一实施例的造口器械的结构示意图；
图2是图1中的造口器械从远端指向近端的侧视图；
图3是图1中的造口器械的切割部与连接件的示意图；
图4A-4C是采用图1的造口器械行造口术的操作示意图；
图5是本发明第二实施例的造口器械的结构示意图；
图6是图5中的造口器械从远端指向近端的侧视图；
图7是图5中的造口器械的环形电极的一部分收容到第二管体中的示意图；
图8是本发明第三实施例的造口器械的切割装置的结构示意图；
图9是本发明第四实施例的造口器械的局部结构示意图；
图10是本发明第五实施例的造口器械的局部结构示意图；
图11是图10中的造口器械从远端指向近端的侧视图。
【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。为方便描述，此处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。本领域的普通技术人员应当知晓，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，以下采用房间隔造口来阐述本造口器械，仅用作举例，并不是对本发明的限制，任何基于本发明教导的方案均在本发明的保护范围以内。
依据本发明实施例的造口器械包括抓取装置和切割装置，抓取装置可通过负气压作用吸住待切割的房间隔组织，切割装置随后切割去除已吸住的组织，从而在房间隔上形成开口。可通过调节负气压的大小和供给负气压的时长来控制吸住的组织的量，吸入的组织的量越多，被切割去除的组织越多，则造口形成的开口的孔径越大，反之亦然。另，在该造口过程中，造口形成的开口无需二次扩张撑开而成形，仅与切割去除的组织的量有关，因此该开口在术后不会因组织回缩而逐渐自行变小甚至闭合，该开口术后形貌稳定。
第一实施例
参见图1-3，依据本发明第一实施例的造口器械1包括抓取装置、切割装置以及导管13。导管13包括管状结构，该管状结构具有远端端面13a、近端端面13b、以及轴向13c。操作中，导管13靠近近端的一部分位于体外，靠近远端的一部分伸入体内。为方便描述，可将导管13沿轴向13c分为远端部分131、近端部分132以及位于远端部分131与近端部分132之间的中间部分133，近端部分132因在操作过程中一直位于体外，其外径长可均大于中间部分133的外径长和远端部分131的外径长。远端部分131的外径长较小可方便导管13进入体内以实施造口术。远端部分131的外径长可略大中间部分133的外径长，有利于行造口术时方便回收切割分离的组织。
导管13的远端端部附近还设有显影结构（图中未示出），可采用现有的任意适合的显影结构，例如显影环，或显影块等。以显影环为例，其被预埋在导管13的远端管壁内，可由黄金、铂铱合金、或钽等金属材料形成。设置显影结构，可在行造口术时为操作导管13进入右心房与提供方便，并结合超声成像设备，方便导管13的远端端面13a顶住房间隔组织，以开始实施造口操作。
抓取装置包括第一管体111和负压源112，负压源112与第一管体111的管腔连通。第一管体111设于导管13内，并与导管13的管状结构同轴，即均具有轴向13c。相应地，第一管体111沿轴向13c的内径长可与导管13沿轴向13c的外径长设置一致，例如，第一管体111的近端部分的内径长可均大于中间部分的内径长和远端部分的内径长，远端部分的内径长略大于中间部分的内径长。
第一管体111的近端与负压源112连通，从而可通过负压源112控制第一管体111内的气压，例如可通过抽负压在第一管体111内形成负气压。第一管体111的远端端面与导管13的远端端面13a齐平，或伸出导管13的远端端面13a。第一管体111的径截面为圆形或近似圆形，其形状可决定造口术形成的开口的形貌，即形成的开口的形貌与第一管体111的径截面形貌基本相同，为圆形或近似圆形。第一管体111的内径长通常略小于待造口形成的开口的径长，例如，第一管体111的内径长可以是2～8mm，或者可以是2～5mm，或者3～4mm，或者7～8mm。
切割装置包括切割部121、第二管体122、以及连接件123。第二管体122设于导管13内，并与导管13的管状结构同轴，即均具有轴向13c。第一管体111与第二管体122并排排列，例如可平行并排排列，一般互不连通。第二管体122的远端端面不超过导管13的远端端面13a。第二管体122的径截面为圆形或近似圆形，例如可以是椭圆形。
连接件123可动地设于第二管体122内，连接件123的远端与切割部121相连，连接件123的近端与导管13外的驱动装置相连（图中未示出），在该驱动装置的作用下，连接件123可在第二管体122内沿轴向13c移动，从而带动远端相连的切割部121移动。例如，切割部121可在连接件123的驱动作用下移动进入第二管体122内，使得切割部121的至少一部分收容于第二管体122内；反之，切割部121还可在连接件123的驱动下从第二管体122中移动释放出来。
本实施例中，连接件123为连接杆，该连接杆的径截面形貌与第二管体122的径截面形貌相同或近似，例如可均为椭圆形，且连接杆的径截面径长略小于第二管体122相应的径截面的内径长，由此连接杆不易在第二管体122内的转动，且不易与第二管体122发生相对径向运动及周向旋转，从而尽可能减少与连接杆相连的切割部121的移位。
连接杆可由导电金属制成，例如可由镍钛合金、不锈钢或铜等金属材料制成，因此，切割部121可直接与连接杆电连接，例如通过焊接方式或金属套管握压方式电连接。或者，连接杆可以是空心管体，其管体内设有导线，切割部121与该导线电连接。
切割部121环绕第一管体111的远端开口，且切割部与第一管体可相对运动，例如切割部121可相对第一管体111径向运动或轴向运动。
切割部121包括环形电极121a和连接段121b，环形电极121a与连接段121b电连接，且该环形电极121a环绕第一管体111的远端开口，连接段121b与连接件123相连，例如直接电连接。环形电极121a和连接段121b可由相同的材料制成，例如可均由导电的弹性金属材料制成，该金属材料可以是镍钛合金、不锈钢或铜等任意适合的金属材料。
环形电极121a可在外力作用下被径向压缩，并在外力撤除后恢复至初始状态。环形电极121a包括至少一圈开口的或闭合的金属环，图中示出了一圈闭合金属环，该金属环在第一管体111的远端端面的远端一侧环绕第一管体111的远端开口。该金属环可以为圆形或近似圆形，例如可以是椭圆，其径长大于第一管体111的远端开口的相应径长，从而可环绕该远端开口。为方便环形电极121a收入第二管体122中，可在环形电极121a上形成V形凸起121c。
在造口器械1的初始状态下，连接杆123（后续采用附图标号123指示）位于第二管体122内并与导管13同轴，即具有轴向13c；环形电极121a位于导管13的远端端面13a的远端一侧并与连接杆非平行相连，两者之间形成夹角a，a大于0°且小于180°，例如，夹角a可以介于30°～120°，或介于30°～90°，图中夹角a为90°。连接杆123在驱动装置作用下，可在第二管体122内沿轴向13c运动，例如，可沿轴向13c向近端方向运动，从而带动环形电极121a沿切割轴向13c的方向运动，该切割轴向13c的方向与轴向13c的方向非平行，从而最终将环形电极121a收容入第二管体122中。此处，定义上述切割轴向13c方向的运动为相对第一管体111的径向运动。连接杆123还可沿轴向13c朝远端方向运动，从而将收容于第二管体122中的环形电极121a逐渐推出第二管体122，并恢复为初始形状，即与连接杆123成夹角a。
切割装置还包括能量源124，该能量源124与切割部121电连接，从而为切割部121提供切割组织的能源。能量源124可包括射频源、微波源等，本实施例中采用射频源，使得切割部121可通过射频消融切除被抓取装置抓住的房间隔组织。例如，射频源输出高频电信号，其高频发生器的工作频率为300kHz~5MHz，优选的，频率范围为400kHz~1000 kHz；该高频电发生器的输出功率不超过300w，优选的，功率范围为50~100w。
造口器械1还包括收集装置，该收集装置与第一管体111的管腔相连，且与负压源集成在一起。收集装置可通过手术过程中负压源产生的负压收集通过第一管体111的负气压吸入的血液以及切割分离的房间隔组织。
图4A-4C示出了依据本实施例的造口器械1行造口术的操作过程。参见图4A，首先，采用现有的常规方法，利用导丝建立股静脉到右心房的血管介入路径，将输送鞘10输送至右心房，然后将导管13推送进输送鞘10，并沿输送鞘10到达右心房。此时，环形电极121a位于导管13的远端一侧，第一管体111的远端开口完全被环形电极121a所环绕。在超声成像设备的辅助下，继续推动导管13，直至导管13的远端端面13a抵靠房间隔100，房间隔100可以为卵圆窝。
参见图4B，启动负压源112对第一管体111抽负压，从而在第一管体111内形成负气压，在该负气压的作用下，抵靠第一管体111的远端开口端面的房间隔100将被吸住并与第一管体111固定贴在一起，此时，环绕第一管体111的远端开口的环形电极121a一并将房间隔100被吸住的一部分环绕在内。持续提供负气压的同时，还可适当地调节负气压的大小，使得第一管体111吸住固定房间隔100的同时还能进一步将房间隔100的一部分组织吸入到第一管体111的管腔内，吸入到第一管体111的管腔内的房间隔组织的多少与供给负气压的时长以及负气压的大小有关。吸入房间隔组织完成之后，驱动连接件123朝近端运动，带动环绕一部分房间隔组织的环形电极121a沿切割轴向13c的方向运动。环形电极121a在运动过程中与房间隔100接触并勒紧房间隔100，利用与环形电极121a电连接的射频源，环形电极121a在勒紧房间隔100的同时还射频消融该房间隔100，从而将这部分已被第一管体111吸住的房间隔组织与房间隔100切割分离。
参见图4C，持续驱动连接件123朝近端运动以带动环形电极121a切割房间隔组织100，直至环形电极121a全部将所环绕的房间隔组织完全与房间隔100切割分离。与房间隔100切割分离的这部分房间隔组织通过负气压被第一管体111吸住并容纳于第一管体111内，一旦与房间隔100完全脱离，则立即会被负气压驱动向第一管体111的近端移动，并最终移出第一管体111而撤出体内，例如，撤出体内后收容于收集装置中。
因一部分组织被切割分离，房间隔100上将形成开口100a，该开口100a的形貌或轮廓与第一管体111的远端开口的形貌一致，该开口100a的大小（即径长）与第一管体111吸入到管腔内的房间隔组织的多少有关，吸入的组织量越多，则表明待切割去除的组织量越多，切割去除的组织量越多，则在房间隔100上切割形成的开口越大，本领域的技术人员可根据具体的实际情况选择合适的切割组织量。例如，通常可在房间隔100上切割形成一个5~10mm的开口100a。
采用本发明的造口器械对房间隔行造口术的过程中，待切割分离的房间隔组织因在切割前已被第一管体吸入到管腔内并固定在管腔内，因此这部分组织被切割下来后不会进入到血液循环系统中，而是直接在负气压作用下在第一管体的管腔内朝近端移动并最终撤出体内，从而避免术中产生二次伤害。
另，本发明采用切割部勒紧房间隔组织并通过射频消融切割分离该组织的切割方式，切割结构简单，例如可采用环形电极；且操作简单，只需驱动切割部移动即可，因此切割操作可靠性高，不易失效。切割过程中无需采用机械刀具，因此切割过程中出血量少且不会在切割过程中溅出微小组织，从而避免机械刀具溅出的微小组织再次在血液循环系统中成为血栓。采用射频消融切割，在切割完成的同时，开口边缘一并被消融止血，进一步减少了出血量。
另，通过本发明的造口器械形成的开口由组织切割去除形成，而并非由小孔扩张撑开形成，因此开口一旦形成则组织不会有明显的回缩，且开口边缘已通过射频消融“焦化”，进一步阻止组织回缩，由此造口形成的开口形貌或轮廓稳定，造口操作可一次成功。
第二实施例
参见图5-7，与第一实施例相比的区别在于，依据本发明第二实施例的造口器械2的切割装置还包括第三管体（图中未示出）和可动地设于第三管体中的拉丝24。
第三管体第设于导管23内，并与导管23的管体同轴，第三管体与第一管体211和第二管体222并排排列，例如可平行并排排列，一般互不连通。第三管体的远端可在导管23的管壁上开口，例如可在导管23的中间部分靠近远端部分的附近形成开口。第三管体的径截面为圆形或近似圆形。
拉丝24的近端从第三管体伸出与驱动装置（图中未示出）相连，从而可在驱动装置（图中未示出）的作用下在第三管体中沿轴向运动。拉丝24的远端伸出第三管体与环形电极221a相连，其连接处位于连接件的相对一侧，还可在环形电极221a的V形突出221c处相连。拉丝24可在驱动下朝近端沿轴向运动，从而朝近端拉住环形电极221a，使环形电极221a紧贴导管23的远端端面23a而环绕第一管体211的远端开口，或者环形电极221a的一部分套设在导管23上而环绕整个远端端面23a，这样一方面可在操作过程中稳定环形电极221a而避免其移位，另一方面还可确保环形电极221a能完全环绕第一管体211的远端开口。
拉丝24可以与环形电极221a可拆卸连接，当房间隔组织被抓住而完全被环形电极221a环绕后，拉丝24可解除与环形电极221a的连接而撤出第三管体。参见图7，拉丝24也可以与环形电极221a固定连接，当连接杆朝近端运动带动环形电极221a径向运动切割组织时，一并带动拉丝24朝近端运动，而不会影响切割组织。
第三实施例
参见图8，与第一实施例相比的区别在于，依据本发明第三实施例的造口器械的切割装置32中，切割部321的环形电极和连接件323分别为同一金属丝的不同部分，环形电极321仍位于第一管体的远端一侧，连接件323仍可动地设于第二管体内。该金属丝具有弹性且具有导电性能，例如可以由镍钛合金、不锈钢或铜等任意适合的金属材料制成。
上述切割装置32中，环形电极321与连接件323一体形成，两者之间无需额外的连接，例如焊接，也无需第三方连接件，例如金属套管，因此两者之间的连接可靠性高，不易在驱动连接件323运动的过程中断裂。另，环形电极321可直接通过连接件323与能量源电连接，无需其它的导线，进一步简化了结构。
第四实施例
参见图9，与第一实施例相比的区别在于，依据本发明第四实施例的造口器械的第一管体411和第二管体422的远端端面均不与导管43的远端端面43a齐平，而是从导管43的远端端面43a伸出一部分。在造口器械的初始状态中，环形电极421a套设于第一管体411上，从而将第一管体411完全地环绕在内，因此一并完全环绕第一管体411的远端开口。
采用该造口器械行造口术过程中，仅第一管体411的远端开口端面直接抵靠房间隔组织，减少了与房间隔组织接触的器械面积。房间隔组织被吸住抓取完成后，朝远端方向推动连接件以带动环形电极421a朝远端移动以环绕住被抓取的房间隔组织，从而可以实施切割和回收组织。此时，环形电极421a通过套设第一管体411而实现环绕第一管体411的远端开口，因此环形电极不会阻挡第一管体411的远端开口，且可以确保完全环绕住被抓取的房间隔组织，方便后续实施切割。
第五实施例
参见图10和11，与第一实施例相比的区别在于，依据本发明第五实施例的造口器械5的切割部521在连接管523的驱动下可与第一管体511相对轴向运动。第二管体（图中未示出）的径长大于第一管体511的径长，且套设于第一管体511上，并与第一管体511同轴。切割部521包括环形电极521a，连接件523包括与该环形电极521a同轴的连接管（以下采用附图标号523指示），连接管523可动地设于第二管体中，环形电极521a与连接管523的一端相连，即与连接管523的远端相连，以一并套设于第一管体511上。在其他实施例中，连接管523与第二管体集成一体。
在一具体实施方式中，切割部521还包括与连接管523同轴的支撑结构521b，环形电极521a通过该支撑结构521b与连接管523相连。此时，环形电极521a的径长小于连接管523与支撑结构521b相连处的径长，且环形电极521a的径长略大于第一管体511的径长。支撑结构521b可采用任意适合的结构，例如可包括一圈沿周向排布的Z形波521c。
采用本实施例的造口器械5行造口术过程中，当第一管体511的远端端面抵靠房间隔组织并抓取组织完成之后，驱动连接管523在第二管体内朝远端移动，以带动与连接管523相连的环形电极521a一并朝远端轴向移动，移动过程中环形电极521a将最终接触并压紧房间隔组织，并对环绕在内的房间隔组织进行射频消融，使其从房间隔上切割分离而形成开口。实施切割过程中，一方面待切割的组织被第一管体511通过负气压的方式吸住，防止其切割分离后脱落，并能在切割分离后旋即在第一管体511内朝近端移动，以撤出体内；另一方面，连接管523与环形电极521a一并还可进一步避免切割下来的组织再次进入血液循环系统，假设有组织在切割后未及时被吸入到第一管体511内，连接管523还可阻挡这部分组织进入血液循环系统，进一步降低了术中风险。
综上，采用本发明的造口器械对房间隔行造口术过程中，待切割的房间隔组织因在切割前已被第一管体吸入到管腔内并固定在管腔内，因此这部分组织被切割下来后不会进入到血液循环系统中，而是直接在负气压作用下在第一管体的管腔内朝近端移动并最终撤出体内，从而避免术中产生二次伤害。

Claims (14)

  1. 一种造口器械，其特征在于，包括抓取装置和切割装置，所述抓取装置包括第一管体和负压源，所述负压源与所述第一管体的管腔连通；所述切割装置包括切割部，所述切割部环绕所述第一管体的远端开口，且所述切割部与所述第一管体可相对运动。
  2. 根据权利要求1所述的造口器械，其特征在于，所述切割装置还包括第二管体和连接件，所述连接件可动地设于所述第二管体内并与所述切割部相连。
  3. 根据权利要求2所述的造口器械，其特征在于，所述切割部在所述连接件的驱动下与所述第一管体相对径向运动。
  4. 根据权利要求3所述的造口器械，其特征在于，所述切割部包括环形电极；所述环形电极环绕所述第一管体的远端开口，并与所述连接件相连。
  5. 根据权利要求4所述的造口器械，其特征在于，所述连接件和所述环形电极分别为同一金属丝的不同部分。
  6. 根据权利要求4所述的造口器械，其特征在于，所述环形电极包括至少一个开口或闭合的金属环。
  7. 根据权利要求4所述的造口器械，其特征在于，所述切割装置还包括第三管体和可动地设于所述第三管体内的拉丝，所述拉丝在所述连接件的相对一侧与所述环形电极连接。
  8. 根据权利要求2所述的造口器械，其特征在于，所述切割部在所述连接件的驱动下与所述第一管体相对轴向运动。
  9. 根据权利要求2所述的造口器械，其特征在于，所述切割部包括环形电极，所述连接件包括与所述环形电极同轴的连接管，所述环形电极与所述连接管的一端相连，且一并套设于所述第一管体上。
  10. 根据权利要求9所述的造口器械，其特征在于，所述连接件还包括与所述连接管同轴的支撑结构，所述环形电极通过所述支撑结构与所述连接管相连。
  11. 根据权利要求1所述的造口器械，其特征在于，所述切割装置还包括能量源，所述能量源与所述切割部电连接。
  12. 根据权利要求11所述的造口器械，其特征在于，所述能量源选自射频源、微波源中的至少一种。
  13. 根据权利要求1至12任一项所述的造口器械，其特征在于，所述造口器械还包括导管，所述第一管体设于所述导管内。
  14. 根据权利要求1所述的造口器械，其特征在于，所述造口器械还包括收集装置，所述收集装置与所述第一管体的管腔连通。
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