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WO2021136252A1 - Système de stomie - Google Patents

Système de stomie Download PDF

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Publication number
WO2021136252A1
WO2021136252A1 PCT/CN2020/140742 CN2020140742W WO2021136252A1 WO 2021136252 A1 WO2021136252 A1 WO 2021136252A1 CN 2020140742 W CN2020140742 W CN 2020140742W WO 2021136252 A1 WO2021136252 A1 WO 2021136252A1
Authority
WO
WIPO (PCT)
Prior art keywords
sheath
sheath tube
main shaft
proximal end
joint structure
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/CN2020/140742
Other languages
English (en)
Chinese (zh)
Inventor
高国庆
王永胜
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.)
Hangzhou Noya Medtech Co Ltd
Original Assignee
Hangzhou Noya Medtech 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
Priority claimed from CN201911418566.5A external-priority patent/CN113116500B/zh
Priority claimed from CN201922502029.0U external-priority patent/CN211934282U/zh
Application filed by Hangzhou Noya Medtech Co Ltd filed Critical Hangzhou Noya Medtech Co Ltd
Publication of WO2021136252A1 publication Critical patent/WO2021136252A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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

Definitions

  • This application relates to the technical field of medical devices, in particular to a stoma system.
  • Heart failure (abbreviated as heart failure) is a group of complex clinical syndromes in which the ventricular filling or ejection ability is impaired due to any abnormality in the structure or function of the heart.
  • the main clinical manifestations are dyspnea and fatigue (restricted activity tolerance), and Fluid retention (pulmonary congestion and peripheral edema).
  • Heart failure is the severe and terminal stage of various heart diseases, with a high incidence, and is one of the most important cardiovascular diseases today. According to the location of heart failure, it can be divided into left heart, right heart and total heart failure.
  • Heart failure is a serious disease with a high incidence and fatality rate.
  • the incidence of heart failure in my country is 2-3%, which is above 12 million.
  • the main causes of heart failure are hypertension, coronary heart disease, myocardial infarction, heart valve disease, atrial fibrillation, cardiomyopathy, etc.
  • Cardiovascular disease causes damage to the left ventricle, leading to pathological remodeling of the left ventricle, resulting in hypofunction of the heart. Every time a patient with a myocardial infarction is successfully treated, a potential heart failure patient is brought.
  • pulmonary hypertension is a group of diseases characterized by a progressive increase in the circulatory resistance of the pulmonary system. Its pathological changes include pulmonary vasoconstriction and remodeling, abnormal proliferation of pulmonary vascular smooth muscle and endothelial cells, and in situ thrombosis. Lead to right heart failure and death.
  • pathological changes include pulmonary vasoconstriction and remodeling, abnormal proliferation of pulmonary vascular smooth muscle and endothelial cells, and in situ thrombosis. Lead to right heart failure and death.
  • the treatment plan for pulmonary hypertension should be individualized and systematized. It is by no means a single drug that can be treated.
  • the treatment methods include: general therapy, non-specific drug therapy, targeted drug therapy, NO inhalation therapy, gene therapy, intervention Treatment with surgery.
  • Atrial septal ostomy is a stoma in the patient's atrial septum to form a shunt between the left and right heart chambers. It can be used to treat pulmonary hypertension (right-to-left shunt) or left heart failure (left-to-right shunt), and it has been clinically proven Effectiveness.
  • the prior art provides a stoma stent, and can respectively publish an implant for atrial shunt.
  • the feature is that after percutaneous atrial septal puncture, the A skin-delivery implant is implanted with a shunt device at the atrial septal puncture to keep the shunt opening unobstructed.
  • the implantation of the shunt device can easily lead to thrombosis, or the device falls off, forming an embolism.
  • the endothelium crawls, the opening of the device is blocked, and the channel is closed and loses the shunting effect.
  • the present application provides a stoma system.
  • a stoma system includes a handle, a sheath tube assembly, and an electrode holder.
  • the sheath tube assembly includes the sheath tube and a pusher movably mounted on the sheath.
  • the electrode support is fixed to the pusher
  • the distal end is accommodated in the sheath
  • the electrode stent is accommodated at the distal end of the sheath assembly
  • the electrode stent establishes a shunt channel in the stoma tissue through expansion and ablation
  • the handle includes a delivery device
  • the delivery device includes a sheath tube joint structure, a push rod joint structure, and a transmission structure.
  • the sheath tube joint structure is fixedly connected to the proximal end of the sheath tube, and the push rod joint structure is fixed to the proximal end of the pusher.
  • the push rod joint structure is connected to the sheath tube joint structure through the transmission structure; the sheath tube joint structure drives the sheath tube to move in the axial direction, and the transmission structure drives the push rod joint structure
  • the pushing member is pushed to move in a direction opposite to the moving direction of the sheath, so as to release or recover the electrode holder.
  • the ostomy system connects the sheath tube through the sheath tube joint structure in the delivery device, the push rod joint structure is connected to the pusher, the sheath tube joint structure drives the push rod joint structure to move through the transmission structure, and the sheath tube joint structure and
  • the movement direction of the push rod joint structure is opposite, that is, the movement direction of the sheath tube and the pusher is opposite, which improves the release and recovery speed of the electrode stent, and facilitates the compression of the proximal end of the electrode stent in the radial direction through the sheath during the recovery process.
  • the radial dimension of the electrode holder becomes smaller, the axial dimension becomes larger, and the electrode holder recovers more smoothly.
  • Fig. 1 is a three-dimensional schematic diagram of the stoma system provided by the first embodiment of the application;
  • Figure 2 is a three-dimensional exploded schematic view of the stoma system shown in Figure 1;
  • Figure 3 is a three-dimensional schematic diagram of the electrode holder
  • Figure 4 is a cross-sectional view of the sheath assembly
  • Figure 5 is a perspective schematic view of a part of the structure of the stoma system
  • Figure 6 is a cross-sectional view along the line A-A shown in Figure 5;
  • Figure 7 is a cross-sectional view along the line B-B shown in Figure 5;
  • Figure 8 is a three-dimensional schematic diagram of the adjustable rack
  • Figure 9 is a three-dimensional schematic diagram of the adjusting gear set
  • Figure 10 is a three-dimensional schematic diagram of a sheath tube joint
  • Figure 11 is a perspective schematic view of the active rack
  • Figure 12 is a three-dimensional schematic view of the active rack from another perspective
  • Figure 13 is a three-dimensional schematic diagram of the sheath tube joint and the active rack in a snapped connection state
  • Figure 14 is a cross-sectional view taken along the line X-X shown in Figure 13;
  • Figure 15 is a three-dimensional schematic diagram of the main shaft
  • Figure 16 is a cross-sectional view of part of the structure of the stoma system when the hook is moved to the nearest end of the accommodating cavity;
  • Figure 17 is an enlarged schematic diagram of area I in Figure 16
  • Fig. 18 is a perspective schematic view of the structure of the push rod joint
  • Fig. 19 is another perspective schematic view of the structure of the push rod joint
  • Figure 20 is a three-dimensional exploded schematic view of the main shaft and the locking member of the stoma system
  • Figures 21-23 are three-dimensional exploded schematic diagrams of the stoma system provided by the second embodiment of this application from different perspectives;
  • FIG. 24 is a three-dimensional schematic diagram of the sheath joint structure provided by the second embodiment of the application.
  • Figure 25 is a partial structural diagram of the ostomy system when the active rack spacing transmission structure is set
  • Figure 26 is a cross-sectional view along line C-C in Figure 25;
  • Figure 27 is a partial structural diagram of the stoma system when the active rack engages the transmission structure.
  • the position close to the operator is defined as the proximal end, and the position far away from the operator is defined as the distal end;
  • the direction of the central axis of rotation of objects such as cylinders and tubes is defined as the axial direction.
  • the direction perpendicular to the axial direction is defined as the radial direction.
  • FIG. 1 is a three-dimensional schematic diagram of the ostomy system provided by the first embodiment of the application
  • FIG. 2 is a three-dimensional exploded schematic diagram of the ostomy system shown in FIG. 1, and the ostomy system 100 includes an electrode holder 10 , Sheath assembly 20 and handle 30.
  • the electrode stent 10 is housed at the distal end of the sheath assembly 20, and the electrode stent 10 establishes a shunt channel in the tissue at the stoma through expansion and ablation.
  • Fig. 3 is a perspective view of the electrode holder.
  • the electrode holder 10 is released at the puncture position of the tissue at the stoma of the patient, and an artificial "defect" is formed in the tissue at the stoma of the patient through radiofrequency ablation.
  • the electrode holder 10 includes a proximal portion 11, a waist portion 13, and a distal portion 15 fixedly connected in sequence.
  • the proximal portion 11 is received at the distal end of the sheath assembly 20.
  • the diameter of the waist 13 is the smallest, that is, the two ends of the electrode stent 10 are thick, the middle is thin, and the waist is drum-shaped.
  • the waist 13 is conductive, and is used to establish a shunt channel in the stoma tissue through expansion and ablation. Since the electrode stent 10 is used to establish a shunt channel for the tissue at the stoma through expansion and ablation, the shunt channel will not close in a short time. It can be understood that the waist 13 is not limited to be conductive, and it can also be conductive in other areas of the electrode holder 10, such as the distal portion 15.
  • the sheath assembly 20 includes a sheath 21, a pusher 23, a first inner sheath core 24 and a second inner sheath core 25.
  • the pushing member 23 is movably installed in the sheath 21.
  • the proximal portion 11 of the electrode holder 10 is fixed to the distal end of the pusher 23 and is contained in the sheath tube 21. After the electrode holder 10 is released from the sheath tube assembly 20, the electrode holder 10 is located at the distal end of the sheath tube assembly 20 and The sheath 21 extends out (as shown in Figure 2).
  • the proximal end of the sheath tube 21 and the proximal end of the pushing member 23 are both connected with the handle 30.
  • the first inner sheath core 24 and the second inner sheath core 25 are inserted into the pushing member 23.
  • the outer wall of the pushing member 23 and the inner wall of the sheath tube 21 have a gap, and the pushing member 23 and the sheath tube 21 can move relative to each other.
  • the pushing member 23 is a multi-lumen tube.
  • the pushing member 23 includes a first cavity 231 and a second cavity 233 spaced apart, and the first inner sheath core 24 and the second inner sheath core 25 pass through the same In a first lumen 231, the first inner sheath core 24 and the second inner sheath core 25 are hollow lumens.
  • the second inner sheath core 25 is used to pass a guide wire (not shown in the figure), and the sheath tube assembly 20 is used to run along the guide wire in the blood vessel to the stoma.
  • the ostomy system 100 further includes a cable 40, which is threaded through the second cavity 233, and the distal end of the cable 40 is used to connect with the electrode holder 10.
  • the distal end of the cable 40 is connected to the proximal portion 11 of the electrode holder 10, the outer layers of the proximal portion 11 and the distal portion 15 are provided with an insulating coating, and the proximal portion 11 and the distal portion 15 are in the insulating coating.
  • the wrapped part is electrically connected to the waist 13.
  • the proximal end of the cable 40 is used to connect with a radio frequency power source for the electrode holder 10 to expand and ablate the tissue at the stoma.
  • the number of second channels 233 is two, and the number of cables 40 is two. Each cable 40 is placed in a second channel 233. The two cables 40 are used to transmit bipolar radio frequency. The signal is sent to the electrode holder 10.
  • the cable 40 is omitted from one of the second channels 233, that is, the electrode holder 10 is electrically connected with a cable 40 to transmit a unipolar radio frequency signal.
  • a plurality of cavities are arranged in the pusher 23 at intervals to reduce interference between the structures (such as cables 40, guide wires, etc.) inserted in the pusher 23, which is beneficial to improve the accuracy of the ostomy operation.
  • the electrode holder 10 uses one or any combination of heat, cold, light, electricity, gas, mechanical waves, electromagnetic waves, radioactive particles, and chemical agents to ablate the stoma tissue. Accordingly, the pusher The second cavity 233 used for accommodating the cable 40 in 23 can also be used for accommodating the medium for transmitting the above-mentioned substances.
  • the pushing member 23 may also be a single-lumen tube, and the cable 40, the inner sheath core, etc. may be worn in the pushing member 23.
  • the handle 30 includes a spindle 31, a diameter adjusting device 33 and a conveying device 35.
  • the diameter adjusting device 33 is provided at the proximal end of the main shaft 31, and is used to adjust the diameter of the electrode holder 10 after being released from the sheath 21, so as to adapt to the needs of different patients.
  • the main shaft 31 is provided with a guide groove 311 along the axial direction.
  • the delivery device 35 is housed in the guide groove 311 and is used to deliver the electrode stent 10 to the tissue at the stoma.
  • the adjusting device 33 includes an adjusting structure 331, an adjusting wire 333 and a scale component 335.
  • the proximal end of the diameter-adjusting wire 333 is fixedly connected to the diameter-adjusting structure 331, and the distal end of the diameter-adjusting wire 333 is wound around the waist 13 of the electrode holder 10.
  • the diameter adjusting structure 331 controls the diameter adjusting wire 333 to adjust the waist 13, it can drive the scale assembly 335 to display the diameter or diameter change information of the waist 13 of the electrode holder 10.
  • the diameter adjusting structure 331 includes a diameter adjusting member 3311 and a diameter adjusting knob 3313.
  • the diameter adjusting member 3311 is movably received in the guide groove 311.
  • the adjusting knob 3313 is screwed to the adjusting member 3311, and the adjusting knob 3313 is used to drive the adjusting member 3311 to move along the axial direction in the guide groove 311 when rotating.
  • the diameter adjusting knob 3313 is disposed close to the proximal end of the main shaft 31.
  • the adjusting wire 333 includes a drawing wire 3331 and a adjusting wire 3332 (as shown in FIG. 3).
  • the proximal end of the wire drawing 3331 is fixedly connected with the diameter adjusting member 3311.
  • the wire drawing 3331 is inserted into the delivery device 35 and the first inner sheath core 24 (as shown in FIG. 4).
  • the proximal end of the adjusting wire 3332 is fixedly connected with the distal end of the drawing wire 3331, and the distal end of the adjusting wire 3332 is wound around the waist 13 of the electrode holder 10 (as shown in FIG. 3).
  • the wire drawing 3331 is a wire made of a material with strong rigidity, such as a metal wire. In this way, the wire drawing 3331 moves back and forth in the first inner sheath core 24 without bending or entanglement, which is convenient for control; the adjusting wire 3332 A wire made of a more flexible material, such as a thinner high-molecular polymer suture, has a higher flexibility and is convenient for winding and adjusting the diameter of the waist 13.
  • the material of the drawing wire 3331 is not limited, and the material of the adjusting wire 3332 is not limited.
  • the adjusting wire 333 is made of a material, such as a metal wire or a suture thread, and the diameter of the adjusting wire 333 is gradually tapered from the proximal end to the distal end.
  • the scale assembly 335 includes a pointer plate 3351 and a scale 3353 that are stacked.
  • the pointer plate 3351 is arranged on the main shaft 31 and covers the opening of the guide groove 311.
  • the pointer board 3351 is connected with the adjusting member 3311.
  • the dial 3353 is fixed on the main shaft 311 through a cover 36 (as shown in FIG. 2). In other words, the cover 36 and the main shaft 311 are relatively stationary, and the cover 36 is used to carry the dial 3353.
  • the dial 3353 can be carried by arranging a groove on the cover 36.
  • the pointer plate 3351 is located between the dial 3353 and the diameter adjusting member 3311.
  • a pointer (not shown), such as a vertical line, is provided on the side of the pointer plate 3351 facing the dial 3353.
  • the dial 3353 has a transparent structure, and the dial 3353 is provided with scales (not shown).
  • the pointer plate 3351 is driven to move synchronously, so that the pointer points to the corresponding scale on the dial 3353.
  • the setting position and connection relationship of the scale assembly 335 on the main shaft 31 are not limited.
  • the pointer plate 3351 can also be accommodated in the guide groove 311, the scale plate 3353 is directly fixed to the main shaft 31, and the pointer plate 3351 can be accompanied by the adjusting member 3311 moves and indicates the scale corresponding to the dial 3353.
  • the diameter adjusting member 3311 includes a diameter adjusting joint 3321 and a diameter adjusting rack 3323.
  • the adjusting joint 3321 is screwed to the adjusting knob 3313 ( Figure 2).
  • the diameter adjusting joint 3321 is fixedly connected to the proximal end of the diameter adjusting rack 3323.
  • the pointer plate 3351 is provided with a plate rack (not shown), the diameter adjusting device 33 also includes a diameter adjusting gear set 337 rotatably received in the guide groove 311, and the plate rack faces the adjusting gear set 337, And it meshes with the adjusting gear set 337. Referring to FIG.
  • the adjusting gear set 337 includes a first gear 3371 and a second gear 3373 that are concentrically arranged.
  • the diameter of the first gear 3371 is smaller than the diameter of the second gear 3373.
  • the first gear 3371 meshes with the adjusting rack 3323.
  • the second gear 3373 meshes with the plate rack, so that the small displacement change of the diameter adjustment line 333 in the axial direction is enlarged and displayed on the dial 3353, which is convenient for the operator to obtain the diameter or diameter change of the waist 13 of the electrode holder 10 information.
  • the ostomy system 100 provided in the present application can be applied to ostomy operations such as cardiac atrial septal tissue stoma, gastrointestinal stoma, and arteriovenous fistula.
  • ostomy operations such as cardiac atrial septal tissue stoma, gastrointestinal stoma, and arteriovenous fistula.
  • the waist 13 is used to transport the tissue to the puncture position of the stoma.
  • the proximal portion 11 and the distal portion 15 ( Figure 3) are respectively located at the openings on both sides of the puncture position.
  • a preset stoma diameter can be calculated according to the patient’s condition. Subsequently, the diameter of the waist 13 is adjusted to be equal to or close to (for example, the error range is within 5%) the preset stoma diameter.
  • the adjustment rack 3323 drives the pointer plate through the adjustment gear set 337
  • the pointer on the 3351 moves relative to the dial 3353 and indicates the larger size on the dial 3353.
  • the diameter of the waist 13 of the electrode holder 10 needs to be adjusted.
  • the adjusting knob 3313 is used to drive the adjusting rack 3323 to move proximally, thereby driving the drawing wire 3331 and the adjusting wire 3332 to move proximally, the adjusting wire 3332 wound around the waist 13 is tightened, and the electrode holder 10
  • the diameter of the waist 13 will become smaller, and the diameters of the proximal part 11 and the distal part 15 will also decrease accordingly.
  • the diameter adjusting rack 3323 drives the pointer on the pointer plate 3351 to move relative to the dial 3353 and indicate to the dial 3353 On the smaller size.
  • the scale component 335 can accurately indicate the diameter of the waist 13 of the electrode holder 10, thereby facilitating the operator to control the size of the shunt channel required for establishment.
  • the diameter adjustment range is 4.0-16.0mm. It can be understood that the diameter adjustment size range is not limited to 4.0-16.0 mm, and the diameter adjustment wire 3332 wound on the waist 13 can be adjusted according to the actual condition of the patient according to the determined size of the waist 13.
  • the structure of the adjusting gear set 337 is not limited.
  • the adjusting gear set 337 meshes with the adjusting rack 3323, the adjusting gear set 337 meshes with the pointer plate 3351, and the adjusting gear set 337 can drive the pointer plate 3351 to move. .
  • the adjusting gear set 337 can be omitted, and the adjusting member 3311 can directly drive the pointer plate 3351 to move; the scale assembly 335 can be omitted, that is, the ostomy system 100 does not have the function of displaying the diameter or diameter change information of the electrode holder 10.
  • the conveying device 35 includes a rotating drum 351, a sheath tube joint structure 353, a push rod joint structure 355 and a transmission structure 356.
  • the rotating cylinder 351 is sleeved outside the main shaft 31 and used to drive the sheath joint structure 353, the push rod joint structure 355, and the transmission structure 356 to move.
  • the sheath joint structure 353, the push rod joint structure 355 and the transmission structure 356 are all received in the guide groove 311 of the main shaft 31.
  • the sheath joint structure 353 is engaged with the inner surface of the spin barrel 351.
  • the sheath joint structure 353 is fixedly connected to the proximal end of the sheath tube 21, and the push rod joint structure 355 is fixedly connected to the proximal end of the pushing member 23.
  • the push rod joint structure 355 is connected to the sheath joint structure 353 through the transmission structure 356.
  • the sheath joint structure 353 drives the sheath 21 to move in the axial direction
  • the transmission structure 356 drives the push rod joint structure 355 to push the pusher 23 to move in the direction opposite to the movement direction of the sheath 21, that is, the direction of movement of the pusher 23 and the sheath 21
  • the electrode holder 10 is thereby released or recovered.
  • the sheath tube joint structure 353 drives the sheath tube 21 to move in the axial direction of the main shaft 31 from the distal end to the proximal direction, and the transmission structure 356 can drive the push rod joint structure 355 to push the pusher.
  • 23 moves from the proximal end to the distal direction along the axial direction of the main shaft 31 to release the electrode holder 10 contained in the sheath tube 21, that is, the electrode holder 10 exposes the distal end of the sheath tube 21.
  • the sheath tube joint structure 353 drives the sheath tube 21 to move along the axial direction of the main shaft 31 from the proximal end to the distal direction, and the transmission structure 356 can drive the push rod joint structure 355 to push the pusher. 23 moves from the distal end to the proximal direction along the axial direction of the main shaft 31, so that the electrode holder 10 is retracted and contained in the sheath 21.
  • the conveying device 35 is a linkage device, which facilitates control and simplifies the conveying steps of the electrode holder 10. Conducive to improving the efficiency of ostomy surgery.
  • the transmission structure 356 is a transmission gear set.
  • the sheath joint structure 353 includes a sheath joint 3531 and an active rack 3532 that are spaced apart along the axial direction of the main shaft 31.
  • a push rod 27 is also provided in the sheath assembly 20. The push rod 27 passes through the first cavity 231 and is sandwiched between the pusher 23 and the sheath 21. In between, it is used to prevent friction between the pusher 23 and the sheath tube joint 3531 in the main shaft, and increase the protection of the mechanical and electrical properties of the inner sheath core.
  • the sheath tube connector 3531 includes a connector member 3533 and an engaging member 3534 protruding from the proximal end of the connector member 3533.
  • a first thread 3535 is provided on the bottom surface of the joint 3533 away from the guide groove 311.
  • the inner surface of the barrel 351 is provided with a second thread 3511 (as shown in Figure 2), the first thread 3535 is engaged with the second thread 3511, so that when the barrel 351 rotates, the sheath tube connector 3531 can be driven in the guide groove 311 Move along the axis.
  • the engaging member 3534 includes a groove 3536 and a hook portion 3537 connected to each other, wherein the hook portion 3537 is located at the proximal end of the engaging member 3534 away from the joint member 3533.
  • the groove 3536 is used for engaging with the active rack 3532.
  • the active rack 3532 is located between the sheath tube joint 3531 and the transmission structure 356.
  • the active rack 3532 meshes with the transmission structure 356.
  • the active rack 3532 includes a main body 3541, a first elastic member 3542 and a second elastic member 3543, and the main body 3541 is received in the guide groove 311 of the main shaft 31.
  • the proximal end of the main body 3541 is provided with a plurality of teeth engaged with the transmission structure 356.
  • the distal end of the main body 3541 is provided with a receiving groove 3545 (as shown in FIG. 12) along the axial direction for inserting the engaging member 3534.
  • the main body 3541 is provided with a through hole 3546 communicating with the accommodating groove 3545.
  • the first elastic member 3542 is disposed on the side of the main body 3541 away from the bottom surface of the guide groove 311. In this embodiment, the first elastic member 3542 extends in the axial direction.
  • FIG. 13 is a three-dimensional schematic diagram of the sheath tube joint and the active rack in an engaged state
  • FIG. 14 is a cross-sectional view along the line X-X shown in FIG. 13.
  • the second elastic member 3543 is substantially in an "n" shape.
  • the second elastic member 3543 includes a connecting portion 3547 and a bending portion 3548 formed by bending and extending the end of the connecting portion 3547.
  • the connecting portion 3547 extends through the through hole 3546 into the accommodating groove 3545 (FIG. 12 ).
  • the connecting portion 3547 is sandwiched between the first elastic member 3542 and the main body 3541.
  • the bending portion 3548 is received in the main body 3541 and partially exposed outside the main body 3541.
  • the side wall of the guide groove 311 is provided with an inclined portion 313 extending in the axial direction (see also FIG. 6 ).
  • the angle between the inclined portion 313 and the axial parallel direction of the main shaft 31 is an acute angle.
  • the proximal end of the inclined portion 313 moves closer to the axial parallel direction, and the distal end of the inclined portion 313 The ends move away from the axial parallel direction.
  • the bent portion 3548 exposes the portion of the main body 3541 to be in contact with the inclined portion 313.
  • the bent portion 3548 is located at the distal end of the inclined portion 313.
  • the sheath tube connector 3531 moves from the distal end to the proximal direction, that is, the sheath tube connector 3531 moves toward the active rack 3532, and the sheath connector 3531 is inserted into the receiving groove 3545 of the active rack 3532, and the hook part 3537 contacts the connecting portion 3547 of the second elastic member 3543 in the accommodating groove 3545, and as the sheath connector 3531 gradually moves proximally, the hook 3537 lifts the connecting portion 3547 in the accommodating groove 3545 (as shown in Figure 7).
  • the sheath joint 3531 drives the active tooth
  • the bar 3232 continues to move from the distal end to the proximal direction, the bent portion 3548 moves proximally along the distal end of the inclined portion 313, and the proximal end of the active rack 3232 can drive the transmission structure 356 to move.
  • the sheath joint 3531 and the active rack 3532 are integrated, if the active rack 3532 moves from the proximal end to the distal direction, the bending part 3548 moves along the inclined part 313, because the bottom wall of the inclined part 313 of the main shaft 31 is Inclinedly, the second elastic member 3543 is lifted until the bottom of the hook portion 3537 and the connecting portion 3547 do not overlap in the axial direction, and the bottom of the connecting portion 3547 cannot block the hook portion 3537, so that the hook portion 3537 of the engaging member 3534 It is removed from the accommodating groove 3545, and the sheath tube connector 3531 is separated from the active rack 3532.
  • the inclined portion 313 has a groove structure, and the end wall of the inclined portion 313 can abut the bending portion 3548, so as to limit the movement displacement of the active rack 3532.
  • the push rod joint structure 355 includes a push rod joint 3551 and a driven rack 3553 fixedly connected to the distal end of the push rod joint 3551, the push rod joint 3551 and the pusher 23 Fixed proximal connection.
  • the wire drawing 3331 passes through the sheath tube connector 3531 and the push rod connector 3551.
  • the driven rack 3553 meshes with the transmission structure 356.
  • the conveying device 35 further includes a locking member 357.
  • the bottom of the guide groove 311 is provided with a receiving hole 315 through the bottom, and the receiving hole 315 includes a first receiving hole 3151 and a second receiving hole 3153 arranged at the bottom of the guide groove 311 at intervals.
  • the locking member 357 includes a connecting portion 3571, a resisting portion 3573, and a locking portion 3575 that are connected in sequence.
  • the distal end of the connecting portion 3571 is pivotally connected to the distal end of the first receiving hole 3151.
  • the connecting portion 3571 and the resisting portion 3573 can be received in the first receiving hole 3151.
  • the resisting portion 3573 is a boss formed by bending and extending the proximal end of the connecting portion 3571 toward the side where the main shaft 31 is located.
  • the proximal end of the locking portion 3575 can be received in the second receiving hole 3153.
  • the proximal end of the locking portion 3575 is provided with a first locking tooth 3576 on the side facing the main shaft 31, and the push rod joint 3551 is provided with a second locking tooth 3554 for meshing with the first locking tooth 3576 on the side of the push rod joint 3551 facing the main shaft 31.
  • the resisting portion 3573 is not limited to be a boss, and it may also have other structures capable of resisting the sheath connector 3531.
  • the push rod joint structure 355 is positioned by the locking member 357 and cannot be moved, that is, the locking member 357 is in the locked position.
  • the driving rack 3532 is always meshed with the transmission joint 356, and the driven rack 3553 is always meshed with the transmission joint 356.
  • the active rack 3532 is not engaged with the sheath connector 3531, the sheath connector 3531 is separated from the active rack 3532, the active rack 3532 does not move synchronously with the sheath connector 3531, and the locking member 357 is in the locked position.
  • the sheath tube connector 3531 pushes the resisting portion 3573, the locking portion 3575 (proximal end) of the locking member 357 rotates in a direction away from the main shaft 31, and disengages the push rod joint structure 355 before the driving rack 3532 pushes the transmission gear set to rotate, The unlocking of the push rod joint structure 355 is realized.
  • the sheath tube connector 3531 While the rotating cylinder 351 drives the sheath tube connector 3531 to move from the proximal end to the distal direction in the guide groove 311, the sheath tube connector 3531 continues to push the resisting portion 3573 and is positioned at the largest diameter of the proximal portion 11 of the electrode holder 10 Before being recovered or retracted into the sheath tube 21, after the active rack 3532 is disengaged from the transmission structure 356, the sheath tube connector 3531 is away from the resisting portion 3573, and the locking member 357 engages with the push rod connector structure 355 to realize the push rod Positioning of the joint structure 355.
  • the conveying device 35 further includes an elastic member 358, one end of the elastic member 358 is fixed to the side of the locking portion 3575 away from the main shaft 31 by welding.
  • the handle 30 also includes a housing 37 (as shown in FIG. 2) and a handle 38 (as shown in FIG. 2).
  • the housing 37 is sleeved on the proximal end of the main shaft 31.
  • the elastic member 358 is located between the locking portion 3575 and the inner wall of the housing 37, and is used to reset the locking member 357 when the sheath tube connector 3531 is away from (not in contact with) the resisting portion 3573, and pushing the locking portion 3575 to the adjacent main shaft 31 Turning in the direction, the proximal end of the locking member 357 and the push rod joint structure 355 are locked together, that is, the first locking tooth 3576 engages with the second locking tooth 3554.
  • the handle 38 is sleeved on the distal end of the main shaft 31, and the rotating drum 351 is located between the handle 38 and the housing 37.
  • the housing 37, the handle 38 and the rotating drum 351 together constitute the outer shell of the handle 30.
  • the ostomy system 100 to establish a shunt channel for the atrial septum of the heart as an example.
  • the stoma is the atrial septum between the left atrium and the right atrium of the heart, that is, the ostomy system 100 is used to treat the atrial septum of the heart.
  • Establish a shunt channel is the atrial septum between the left atrium and the right atrium of the heart, that is, the ostomy system 100 is used to treat the atrial septum of the heart.
  • a puncture mechanism is used to puncture the atrial septum.
  • the guide wire is fed into the left upper pulmonary vein, and the puncture kit is removed.
  • the dilator and sheath assembly 20 is pushed into the left atrium along the guide wire of the second inner sheath core 25, and the guide wire and dilator are removed.
  • the electrode holder 10 is pushed through the inner cavity of the second inner sheath core 25 along the guide wire into the left atrium.
  • the state of the ostomy system 100 is the initial state: at the distal end of the ostomy system 100, the opening of the pusher 23 is retracted inside the opening of the sheath 21, and the diameter of the waist 13 is adjusted by the diameter adjustment wire 3332.
  • the waist 13 is fixed to the distal end of the pusher 23 by the adjusting wire 3332, so that the electrode holder 10 cannot move back and forth in the axial direction.
  • the electrode holder 10 is elongated in the axial direction so that it is compressed in the radial direction, and is completely accommodated in the opening of the sheath tube 21, and the distal end portion 15 of the electrode holder 10 does not protrude from the distal end of the sheath tube 21.
  • the sheath joint 3531 and the active rack 3532 are spaced apart and not in contact with each other.
  • the connecting portion 3536 of the second elastic member 3543 is accommodated in the accommodating cavity 3545, and its position is the initial position.
  • the active rack 3532 and the transmission structure 356 Engaged, the driven rack 3553 engages with the transmission structure 356.
  • the sheath connector 3531 is away from the resisting portion 3573 of the locking member 357.
  • the elastic member 358 abuts against the inner wall of the housing 37, and the locking member 357 is located at the locking position, that is, the first locking tooth 3576 engages the second locking tooth 3554.
  • the process of releasing the electrode holder 10 includes:
  • the first period release the distal part 15 of the electrode stent 10 in the left atrium, release the waist 13 at the perforation of the atrial septum, release a part of the proximal part 11 in the right atrium, especially the diameter of the proximal part 11 Biggest place.
  • the barrel 351 drives the sheath connector 3531 to the proximal end along the axial direction. Movement, the sheath tube connector 3531 drives the sheath tube 21 to move proximally, the sheath tube connector 3531 gradually approaches the active rack 3532, and the electrode holder 10 is gradually released from the sheath tube 21.
  • the hook portion 3537 contacts the connecting portion 3547 of the second elastic member 3543 in the accommodating groove 3545, and gradually moves toward the sheath connector 3531. With the proximal movement, the hook portion 3537 lifts the connecting portion 3547 in the accommodating slot 3545 (as shown in Figure 7), and inserts it to the farthest end of the accommodating slot 3545 through the connecting portion 3547 (as shown in Figures 14 and 16).
  • the groove 3536 is facing the connecting portion 3547, and the connecting portion 3547 drops to the initial position; at the same time, or before this moment, the bottom of the sheath tube connector 3531 abuts against the resisting portion 3573 of the locking member 357, and pushes against
  • the holding part 3573 drives the locking part 3575 of the locking part 357 (the proximal end of the locking part 357) to rotate in a direction away from the main shaft 31, so that the resisting part 357 is transformed from the locked position to the unlocked position, so that the push rod joint 3551 can be
  • the pushing member 23 is driven to slide in the guide groove 311 of the main shaft 31 in the axial direction.
  • the second period the proximal portion 11 is further released in the right atrium until the electrode stent 10 is completely released.
  • the sheath tube connector 3531 drives the active rack 3532 to move axially toward the proximal end, and the sheath 21 moves toward the proximal end; the proximal end of the active rack 3532
  • the multiple teeth of the gears mesh with the transmission structure 356 and drive the transmission structure 356 to rotate.
  • the driven rack 3553 meshed with the transmission structure 356 moves distally under the drive of the transmission structure 356, and the push rod joint 3551 drives the pusher 23 to the distal end.
  • the electrode holder 10 Move until the distal end of the pushing member 23 protrudes from the sheath tube 21, the electrode holder 10 is completely released from the sheath tube 21, and after the complete release, since the inner wall of the sheath tube 21 no longer compresses the electrode holder 10, the electrode holder 10 The diameter of the proximal portion 11 of the 10 is enlarged relative to the diameter before the incomplete release, making it easier to fit the anatomical structure of the atrium.
  • the sheath 21 moves to the proximal end, and the pushing member 23 moves to the distal end, that is, the sheath 21 and the pushing member 23 are linked.
  • the sheath 21 and the pushing member 23 are linked, namely The sheath 21 moves to the proximal end, and the pusher 23 moves to the distal end.
  • the waist 13 is fixed, the diameter of the proximal portion 11 is further enlarged, which can better fit the diaphragm between the left and right atria.
  • the waist 13 is tightened by the adjusting wire 3332 so as to be accurately fixed at the puncture position, thereby accurately positioning the position where subsequent ablation is required.
  • Diameter adjustment process After the second period, an appropriate size can be selected for cauterization according to the specific conditions of the patient, and the diameter of the waist 13 of the electrode holder 10 can be adjusted to establish a proper atrial septal shunt channel.
  • Pulse ablation process After confirming that the tissue at the stoma is completely attached to the electrode holder 10, connect the proximal end of the cable 40 to the radio frequency power supply (ablation power supply, not shown), and set the heating parameters (for example, power 20-80W, duration 10-50S), and then start heating. After the heating is stopped, the electrode stent 10 can be recovered to the sheath 21 and removed from the body, and whether the diameter of the stoma reaches the expected value is measured.
  • ablation power supply radio frequency power supply
  • the process of recovering the electrode holder 10 includes:
  • the third period rotate the barrel 351 in the second direction (for example, in the counterclockwise direction viewed from the proximal end to the distal end of the ostomy system 100), the barrel 351 drives the sheath connector 3531 to move axially toward the distal end, and the sheath tube
  • the joint 3531 drives the sheath 21 to move distally.
  • the sheath 21 gradually receives the proximal end of the electrode holder 10 therein; at the same time, the hook 3537 of the active rack 3532 pulls the bottom of the main body 3541 to drive the active rack 3532 to move distally, and the active rack 3532 passes through the transmission structure 356 Drive the driven rack 3553, the push rod joint 3551 and the pushing member 23 to move proximally.
  • the largest diameter of the proximal portion 11 of the electrode holder 10 is outside the sheath 21, and a part of the proximal portion 11 is contained in the sheath 21, under the action of the push rod connector 3551 being pulled proximally ,
  • the radial dimension of the electrode stent 10 is compressed by the inner wall of the sheath tube 21, and the axial length becomes longer, which facilitates the further recovery of the electrode stent 10 into the sheath tube 21, because the radial dimension of the electrode stent 10 can be compressed during the recovery process
  • the recovery of the electrode stent 10 is relatively smooth, so the diameter of the proximal portion 11 of the electrode stent 10 can be designed to be larger to better fit the diaphragm between the left and right atria, thereby improving the accuracy of positioning the ablation site.
  • the sheath tube connector 3531 drives the sheath tube 21 to move distally, and the proximal end of the active rack 3532 is limited by the hook 3537 in the direction perpendicular to the axial direction (cannot be lifted). Since the connecting portion 3547 is disposed on the top surface of the main body 3541 away from the bottom of the guide groove 311, the two bending portions 3548 are connected to one end of the main body 3541 and extend to opposite sides of the main body 3541, that is, the bending portion 3548 exposes the main body 3541. The bottom wall of the inclined portion 313 of the main shaft 31 is inclined and abuts the bottom of the bent portion 3548.
  • the second elastic member 3543 is lifted until the hook portion 3537 and the connecting portion
  • the bottom of the 3547 does not overlap in the axial direction, and the bottom of the connecting portion 3547 cannot block the hook 3537, so the hook 3537 comes out of the accommodating groove 3545, and the sheath joint 3531 is separated from the active rack 3532.
  • the sheath connector 3531 and the resisting portion 3573 of the locking member 357 disengage from each other and slide distally, and the elastic member 358 abuts against the inner wall of the housing 37, so that the proximal end of the locking member 357 is attached to the inner wall of the housing 37.
  • the main shaft 31 is closed, and the lock member 357 is transformed from the unlocked position to the locked position.
  • the sheath tube connector 3531 drives the sheath tube 21 to move distally, and the pusher 23 moves proximally, that is, the sheath tube 21 and the pusher 23 are linked together.
  • the largest diameter of the proximal portion 11 of the electrode holder 10 is outside the sheath 21.
  • the connecting portion 3547 of the second elastic member 3543 is pushed up by the hook portion 3537, the bent portion 3548 is also pushed up by the inclined portion 313.
  • the barrel 351 drives the sheath tube connector 3531 to move distally in the axial direction
  • the sheath tube connector 3531 drives the sheath tube 21 to move distally
  • the active rack 3532 and the pusher 23 It does not move with respect to the main shaft 31.
  • the sheath tube 21 recovers the remaining part of the electrode holder 10 into it.
  • the fourth period after the proximal part 11 is completely retracted into the sheath 21, before the distal part is recovered into the sheath 21, that is, when the waist 13 is at the position of the distal opening of the sheath 21, adjust the circumference of the waist 13
  • the diameter wire 3332 is tightened to prevent the operator from rotating the parts on the handle 30 to recover the electrode holder 10 after the waist 13 has been tightened, causing the electrode holder 10 to move back and forth between the left and right atria and damage the heart tissue. .
  • ostomy system 100 can also be used in ostomy operations such as gastrointestinal stoma and arteriovenous fistula.
  • FIG. 21 is a three-dimensional exploded schematic view of the ostomy system 200 provided by the second embodiment of the present application.
  • the ostomy system 200 provided by the second embodiment of the present application is compared with the ostomy system provided by the first embodiment.
  • the structure of 100 is roughly similar. The difference is that, referring to Figure 24, the sheath tube joint structure 653 includes a fixedly connected sheath tube joint 6531 and an active rack 6532.
  • the active rack 6532 is provided with an interval transmission structure 656 (as shown in FIGS. 25 and 26). ).
  • the active rack 6532 is provided with an interval transmission structure 656, the connecting portion 6571 of the locking member 657 is pivotally connected to the main shaft 611, and the locking portion 6575 of the locking member 657 is connected to the push rod joint structure The bottom of the 655 is locked together.
  • the sheath joint 6531 and the active rack 6532 are always connected in one body. Before the active rack 6532 pushes the transmission structure 356 to rotate, the locking member 657 needs to be separated from the push rod joint structure 655 to prevent the push rod joint structure 655 from being jammed.
  • sheath connector 6531 and the active rack 6532 are not limited to be fixedly connected, and the sheath connector 6531 and the active rack 6532 can move synchronously.
  • the engaging member, the first elastic member, the second elastic member, the accommodating groove, etc. are omitted.
  • the main differences between the process of releasing and recovering the electrode holder 201 and the first embodiment include:
  • the first period the sheath joint structure 653 slides toward the proximal end as a whole, and the active rack 6532 does not contact the transmission structure 656 at the distal end (as shown in FIGS. 25 and 26).
  • the sheath joint structure 653 moves from the distal end Move proximally until the active rack 6532 engages with the transmission structure 656 (as shown in Figure 27).
  • the bottom of the sheath joint structure 653 abuts against the resisting portion 6573 of the locking member 657 and pushes
  • the resisting portion 6573 drives the proximal end of the locking member 657 to rotate in a direction away from the main shaft 611, and the locking member 657 transforms from the locked position to the unlocked position, so that the push rod joint structure 655 can drive the pushing member 623 in the axial direction on the main shaft 611. Sliding inside.
  • the third period the sheath joint structure 653 as a whole slides to the distal end until the active rack 6532 is separated from the transmission structure 656, and the locking member 657 is converted into a locked state.
  • the fourth period the rotating cylinder 651 drives the sheath joint structure 653 as a whole to move along the distal end of the axial direction.
  • the sheath joint 6531 of the sheath joint structure 653 and the active rack 6532 are integral parts, which reduces the components of the ostomy system 200 and simplifies the structure of the ostomy system 200.

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Abstract

L'invention concerne un système de stomie (100, 200), comprenant une poignée (30), un ensemble gaine (20), et une stentrode (10, 201) ; l'ensemble gaine (20) comprend une gaine (21) et un élément d'administration par poussée (23, 623) inséré de manière mobile dans la gaine (21) ; la stentrode (10, 201) est fixée à l'extrémité distale de l'élément d'administration par poussée (23, 623) et est logée dans la gaine (21) ; la stentrode (10, 201) crée un canal de dérivation dans le tissu au niveau de l'emplacement de la stomie par expansion et ablation ; la poignée (30) comprend un dispositif d'administration (35), ledit dispositif d'administration (35) comprenant une structure de connecteur de gaine (353, 653), une structure de connecteur de tige de poussée (355, 655), et une structure de transmission (356, 656) ; la structure de connecteur de gaine (353, 653) est reliée de manière fixe à l'extrémité proximale de la gaine (21) ; la structure de connecteur de tige de poussée (355, 655) est reliée de manière fixe à l'extrémité proximale de l'élément d'administration par poussée (23, 623) ; la structure de connecteur de tige de poussée (355, 655) est reliée à la structure de connecteur de gaine (353, 653) par l'intermédiaire de la structure de transmission (356, 656) ; la structure de connecteur de gaine (353, 653) entraîne la gaine (21) pour se déplacer dans la direction axiale ; la structure de transmission (356, 656) entraîne la structure de connecteur de tige de poussée (355, 655) pour pousser l'élément d'administration par poussée (23, 623) pour se déplacer dans la direction opposée à la direction de déplacement de la gaine (21), et libère ou tire ainsi la stentrode (10, 201).
PCT/CN2020/140742 2019-12-31 2020-12-29 Système de stomie Ceased WO2021136252A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201911418566.5 2019-12-31
CN201922502029.0 2019-12-31
CN201911418566.5A CN113116500B (zh) 2019-12-31 2019-12-31 造口系统
CN201922502029.0U CN211934282U (zh) 2019-12-31 2019-12-31 造口系统

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WO2021136252A1 true WO2021136252A1 (fr) 2021-07-08

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US11633194B2 (en) 2020-11-12 2023-04-25 Shifamed Holdings, Llc Adjustable implantable devices and associated methods
US11801369B2 (en) 2020-08-25 2023-10-31 Shifamed Holdings, Llc Adjustable interatrial shunts and associated systems and methods
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US11801369B2 (en) 2020-08-25 2023-10-31 Shifamed Holdings, Llc Adjustable interatrial shunts and associated systems and methods
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US12090290B2 (en) 2021-03-09 2024-09-17 Shifamed Holdings, Llc Shape memory actuators for adjustable shunting systems, and associated systems and methods

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