WO2019128653A1 - Appareil de déploiement de dispositif médical - Google Patents

Appareil de déploiement de dispositif médical Download PDF

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Publication number
WO2019128653A1
WO2019128653A1 PCT/CN2018/119276 CN2018119276W WO2019128653A1 WO 2019128653 A1 WO2019128653 A1 WO 2019128653A1 CN 2018119276 W CN2018119276 W CN 2018119276W WO 2019128653 A1 WO2019128653 A1 WO 2019128653A1
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WO
WIPO (PCT)
Prior art keywords
catheter
delivery device
medical device
outer sheath
rotating member
Prior art date
Application number
PCT/CN2018/119276
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English (en)
Chinese (zh)
Inventor
江巍
谢惠雄
王刚
Original Assignee
先健科技(深圳)有限公司
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Filing date
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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 WO2019128653A1 publication Critical patent/WO2019128653A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/011—Instruments for their placement or removal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation

Definitions

  • the present invention relates to the field of interventional medical devices, and in particular to a medical device delivery device.
  • the human heart is divided into four chambers, each with its own “outlet”, with four valves (mitral, aortic, pulmonary, and tricuspid) that ensure pumping by the heart.
  • Blood flows through the cardiovascular system in the specified direction.
  • the mitral valve is located between the left atrium and the left ventricle.
  • the normal mitral valve ensures that blood circulation must flow from the left atrium to the left ventricle and through a certain blood flow.
  • the two flexible leaflets of the mitral valve close, preventing blood from flowing back from the left ventricle of the heart to the left atrium.
  • mitral dysfunction causing the mitral valve to become abnormally narrowed or dilated, or allowing blood to flow back from the left ventricle back into the left atrium.
  • Deficiency of the mitral valve function can affect the normal work of the heart, causing people to gradually weaken or endanger life.
  • mitral valve dysfunction there are a variety of treatments for mitral valve dysfunction, such as conventional valve replacement surgery, which is considered an "open heart" procedure.
  • surgery requires surgery to open the chest, start the extracorporeal circulation with a cardiopulmonary machine, open the heart, remove and replace the patient's mitral valve, but due to the complexity of the in vitro cycle and the poor tolerance of elderly patients, "open heart” There is a higher risk of death from surgery.
  • intervention means has been gradually paid attention, and a transcutaneous catheter technique for delivering a replacement mitral valve with less trauma has been developed.
  • the self-puncture prosthetic valve is typically mounted in the crimped state at the end of the flexible catheter and advanced through the patient's blood vessel or body until the prosthetic valve reaches the implantation site.
  • the prosthetic valve then expands to its functional size at the site of the defective native mitral valve.
  • transcatheter interventional technique replacement of the natural mitral valve is an effective method for treatment insufficiency
  • the volume of the prosthetic valve tends to be large, and delivery in the delivery device is more difficult; if the size of the delivery catheter is increased, the patient's heart is The damage will increase accordingly.
  • the replacement system of the existing systems and methods is complicated to manipulate, and it is easy to damage the heart tissue, resulting in poor therapeutic effect.
  • valvular insufficiency such as treatment of mitral regurgitation
  • a suitable prosthetic valve delivery device to deliver the prosthetic valve to a target location and release, requiring a conveyor
  • the operation is simple, the release force of the prosthetic valve is small, and it is convenient for the doctor to operate.
  • the present invention provides a medical device delivery device comprising a hollow catheter assembly and an actuation assembly coupled to the catheter assembly; the catheter assembly including an outer sheath catheter and a connecting catheter extending through the outer sheath catheter;
  • the moving assembly includes a first actuating unit and a second actuating unit disposed axially from the distal end to the proximal end, the first actuating unit being coupled to the outer sheath catheter and actuating the outer sheath catheter, A second actuating unit is coupled to the connecting conduit to drive the connecting conduit to rotate.
  • the first actuating unit includes a first rotating member and a fixing member, the first rotating member has an inner cavity, and the fixing member is received in the inner cavity of the first rotating member.
  • the fixing member is connected to the proximal end of the outer sheath catheter, and the first rotating member that rotates circumferentially drives the fixing member and the outer sheath tube to move axially relative to the first rotating member.
  • the inner wall of the first rotating member is provided with a spiral guiding groove that rotates axially around the first rotating member
  • the fixing member includes a first joint body and is disposed on the first joint body.
  • a rolling member on the side wall, a side wall of the first joint body is provided with a receiving groove for receiving the rolling member, and the rolling member is sandwiched between the guiding groove and the receiving groove, the first A joint body is coupled to the proximal end of the sheath catheter.
  • the guiding groove has a helix angle ranging from 15 degrees to 45 degrees.
  • the first actuating unit further includes a guiding member disposed between the first rotating member and the fixing member, the guiding member having an inner cavity and a side wall, The side wall is provided with an axial limiting opening communicating with the inner cavity of the guiding member, and the limiting opening defines a path for axial movement of the fixing member.
  • the second actuating unit comprises a second rotating member, the second rotating member is connected to the proximal end of the connecting duct, and the connecting portion of the connecting member is only driven when the second rotating member rotates circumferentially. Rotate in the circumferential direction.
  • the actuation assembly further includes a third actuation unit, the third actuation unit being disposed at a proximal end of the second actuation unit, the third actuation unit including a third rotation And a hollow adjusting tube screwed to the third rotating member, when the distal end of the adjusting tube is in contact with the connecting duct, the rotating third rotating member drives the adjusting tube to drive the connecting duct to the far side Move at the end.
  • the third actuation unit further includes a hollow push catheter, the proximal end of the push catheter is fixed on the adjustment tube, and the lumen of the push catheter and the adjustment tube The lumens are connected.
  • the catheter assembly further includes a pusher catheter that extends through the outer sheath catheter, the connecting catheter extending through the pusher catheter.
  • the distal end of the pusher catheter is tapered.
  • the delivery device further includes a handle housing, the first actuation unit, the second actuation unit and the third actuation unit being axially disposed within the handle housing.
  • the distal end of the connecting catheter is provided with a threaded structure through which the connecting catheter is coupled to the medical device.
  • the medical device delivery device comprises a catheter assembly and an actuation assembly comprising two actuation units.
  • the catheter assembly includes an outer sheath catheter and a connecting catheter, the connecting catheter being coupled to the medical device, and the outer sheath catheter housing the medical device.
  • the axial movement of the sheath catheter is controlled by the first actuation unit to effect containment and release of the medical device; the second actuation unit rotation controls the final release of the medical device.
  • the control of the catheter assembly is achieved by the actuation assembly, in particular the first actuation unit converts its circumferential rotation into axial movement of the sheath catheter, making the implantation of the medical device more convenient and labor-saving.
  • FIG. 1 is a schematic structural view of a medical device delivery device according to an embodiment of the present invention.
  • FIG. 2 is a schematic cross-sectional structural view of a medical device delivery device according to an embodiment of the present invention
  • FIG. 3 is a schematic view showing a partial split structure of a medical device delivery device according to an embodiment of the present invention.
  • FIG. 4 is a schematic structural view of a first rotating member of a medical device delivery device according to an embodiment of the present invention.
  • Figure 5 is a schematic cross-sectional view of the first rotating member shown in Figure 4.
  • FIG. 6 is a schematic structural view of a guide member of a medical device delivery device according to an embodiment of the present invention.
  • FIG. 7a is a schematic cross-sectional structural view of a first actuation unit of a medical device delivery device according to an embodiment of the present invention.
  • Figure 7b is an enlarged view of a portion of the structure of Figure 7a;
  • FIG. 8 is a schematic structural view of a second actuation unit and a third actuation unit of a medical device delivery device according to an embodiment of the present invention.
  • Figure 9 is a schematic cross-sectional view of the structure shown in Figure 8.
  • 10a to 10g are schematic views showing an operation procedure of artificial heart valve implantation using the delivery device of the present invention.
  • the medical device delivery device of the present invention can be used for the delivery of a variety of medical devices, such as a filter, an occluder or a prosthetic heart valve, etc., in particular, a suitable delivery device for the outer diameter of the catheter assembly can be selected.
  • a prosthetic heart valve as an example.
  • a medical device delivery device 01 of the present invention includes an actuation assembly 10 and a hollow catheter assembly 20.
  • the proximal end of the catheter assembly 20 is coupled to the distal end of the actuation unit 10, and the actuation assembly 10 can actuate the catheter assembly 20.
  • the actuation assembly 10 includes a first actuation unit 11, a second actuation unit 12, and a third actuation unit 13 that are axially disposed from distal to proximal end.
  • the catheter assembly 20 includes an outer sheath catheter 21, a pusher catheter 22, and a connecting catheter 23 that are coaxially disposed.
  • Each of the outer sheath catheter 21, the push rod catheter 22, and the connecting catheter 23 is of a hollow structure and has openings at both ends.
  • the pusher catheter 22 extends through the outer sheath catheter 21, and the connecting catheter 23 extends through the push rod catheter 22, and the lumen of the connecting catheter 23 is allowed to pass through the guide wire.
  • the proximal end of the outer sheath catheter 21 is coupled to the first actuation unit 11, and the first actuation unit 11 actuates the outer sheath catheter 21 to produce axial movement.
  • the second actuation unit 12 is coupled to the proximal end of the connecting conduit 23 to actuate the connecting conduit 23 to produce a circumferential rotation.
  • the third actuating unit 13 abuts the proximal end face of the connecting conduit 23 to actuate the connecting conduit 23 to produce axial movement.
  • the distal end of the connecting catheter 23 is also provided with a threaded structure (not shown) through which the connecting catheter 23 can be connected or released from the artificial heart valve.
  • the outer sheath catheter 21 provides sufficient support for the delivery of the prosthetic heart valve, and the material thereof may be a single layer of polymer material, a metal or a composite material of a polymer material and a metal, such as PEEK, PC, POM, titanium or PTFE + stainless steel + PEBAX / nylon composite materials.
  • the push rod catheter 22 is used to provide axial support force to the proximal end of the artificial heart valve loaded on the delivery device 01 and axial thrust when releasing the heart valve.
  • the material may be a single layer of polymer material, such as PE , PC, PEBAX or nylon.
  • the connecting catheter 23 is used to connect the artificial heart valve, and the material may be a polymer material or a metal, such as PEEK, stainless steel, nickel titanium or titanium.
  • the distal end of the outer sheath catheter 21 is also provided with a developing ring 211 which can be imaged under the imaging device to indicate the delivery position of the delivery device 01 in the body.
  • the material of the developing ring 211 may be a metal material having good developing characteristics such as platinum, rhodium or tungsten.
  • the delivery device 01 also includes a handle housing 50.
  • the handle housing 50 includes a detachable distal handle housing 51 and a proximal handle housing 52.
  • the distal handle housing 51 includes a distal first half shell 511 and a distal second half shell 512.
  • the distal first half shell 511 and the distal second half shell 512 can be assembled into a distal handle housing 51 by a snap connection, or can be assembled into a distal handle by screwing and nut connection, bonding or welding.
  • the proximal handle housing 52 includes a proximal first half shell 521 and a proximal second half shell 522.
  • the proximal first half shell 521 and the proximal second half shell 522 can be assembled into a proximal handle shell 52 by a snap connection, or can be assembled into a proximal handle by screw and nut connection, bonding or welding.
  • the handle housing 50 is used to provide a receiving and fixing function, and the actuation assembly 10 is housed and assembled.
  • the first actuating unit 11, the second actuating unit 12 and the third actuating unit 13 are arranged axially in the handle housing 50.
  • the first actuation unit 11 and the second actuation unit 12 are both disposed in the middle of the handle housing 50 , and the third actuation unit 13 is adjacent to the proximal end of the handle housing 50 .
  • the handle housing 50 is further provided with a first valve 31 and a second valve 32, and both the first valve 31 and the second valve 32 are preferably luer connectors.
  • the first valve 31 is connected to the syringe to flush the inner cavity of the push rod catheter 22, and the flushing liquid flowing out from the distal end of the push rod catheter 22 can be partially flushed to the distal end of the outer sheath catheter 21, and the second valve 32 is connected with the syringe.
  • the lumen of the connecting catheter 23 can be flushed.
  • the first actuating unit 11 includes a first rotating member 111, a guiding member 112, and a fixing member 113.
  • the first rotating member 111 is a tubular structure having a hollow inner cavity and an inner wall, and includes a proximal rotating portion 111a and a distal rotating portion 111b which are connected and rotatable at the same time.
  • the proximal rotating portion 111a is disposed between the distal handle housing 51 and the proximal handle housing 52
  • the distal rotating portion 111b is disposed in the distal handle housing 51, that is, the operator can operate the proximal rotating portion 111a Rotating to drive the distal rotating portion 111b to rotate.
  • a guide groove 111c is further provided on the inner wall of the first rotating member 111.
  • the guide groove 111c has a spiral shape and is disposed to rotate around the first rotating member 111 in the axial direction.
  • the spiral angle may range from 15 to 45 degrees, and is preferably 18 in this embodiment.
  • the guiding member 112 is disposed in the inner cavity of the first rotating member 111 and has an inner cavity and a side wall 112a.
  • the side wall 112a is further provided with an axial limiting opening 112b communicating with the inner cavity of the guiding member 112.
  • the proximal end of the guide member 112 can be fixed within the handle housing 50 to ensure that the guide member 112 does not move axially relative to the first rotary member 111 when the first actuation unit 11 actuates the outer sheath catheter 21.
  • the fixing member 113 is partially disposed in the inner cavity of the guiding member 112 and is axially movable relative to the guiding member 112.
  • the fixing member 113 includes a first joint main body 113a. The proximal end of the first joint body 113a is clamped in the limiting opening 112b, thereby ensuring that the fixing member 113 only moves axially relative to the guiding member 112 without generating circumferential rotation.
  • the distal end of the first joint body 113a is provided with a distal opening that can receive the proximal end of the sheath catheter 21.
  • the distal end of the first joint body 113a is screwed to the proximal end of the sheath catheter 21.
  • the proximal end of the first joint body and the sheath catheter can also be joined by other means such as snapping, bonding or welding.
  • the fixing member 113 further includes an adjusting member 113b and a first sealing ring 40a provided at a distal end of the adjusting member 113b.
  • the proximal end of the first joint body 113a is further provided with a proximal opening for receiving the adjusting member 113b and the first sealing ring 40a, the proximal opening of the first joint body 113a is in communication with the distal opening, and the push rod conduit 22 passes through the first joint
  • the proximal end opening and the distal end opening of the main body 113a penetrate the inside of the first joint main body 113a.
  • the adjusting member 113b is provided with an external thread, and the proximal end opening of the first joint main body 113a is provided with an internal thread that cooperates with the external thread on the adjusting member 113b.
  • a hemispherical receiving groove 113c is further disposed on the outer side of the proximal end of the first joint main body 113a, and a rolling member 114 is disposed in the receiving groove 113c.
  • the rolling member 114 is specifically disposed between the first joint main body 113a and the guide groove 111c on the inner wall of the first rotary member 111.
  • the rolling member 114 is spherical and has a diameter matching the width of the guide groove 111c, thereby restricting the rolling member 114 from rolling in the guide groove 113c but not falling out of the receiving groove 113c.
  • the number of the rolling elements 114 is at least one. In this embodiment, the number of the guiding grooves 111c is not less than the number of the rolling elements 114.
  • the number of the guiding grooves 111c is also two. It can be understood that, in other embodiments, the receiving groove may also be a quarter-spherical groove, a one-third spherical groove, a penta-spherical groove, or the like.
  • the quarter-spherical groove refers to a groove corresponding to a quarter diameter obtained after cutting the spherical structure in a direction perpendicular to the diameter at a quarter diameter of the hollow spherical structure. .
  • the one-third spherical groove and the one-half spherical groove are similar to the definition method of the quarter-spherical groove, and will not be described herein.
  • the rolling member 114 When the first rotating member 111 is manually rotated, the rolling member 114 is driven to roll. Since the first rotating member 111 is restricted from being rotated by the handle housing, the guiding member 112 restricts the axial movement of the fixing member 113. Therefore, the rolling of the rolling member 114 will drive the fixing member 113 to move axially, thereby driving the axial movement of the sheath catheter 21 connected to the fixing member 113. The circumferential rotation of the first rotating member 111 is converted into the axial movement of the sheath catheter 21 by the guide member 112, so that the force of the outer sheath catheter moving in the axial direction is greatly reduced, and the overall axial dimension of the conveying device 01 is shortened. .
  • the guides may also be omitted, such as by providing a stop strip within the handle housing to ensure that the fastener does not rotate circumferentially relative to the handle housing.
  • the second actuating unit 12 includes a second rotating member 122 and a connecting member 121 connected to the connecting duct 23.
  • the second rotating member 122 has a stepped axial through hole 125, and the distal end is provided with an opening capable of receiving the connecting duct 23.
  • the axial through hole 125 includes a distal end portion 125a having a larger aperture and a proximal end portion 125b having a smaller aperture.
  • the distal end portion 125a has a rectangular cross section.
  • the connecting member 121 is located at the distal end portion 125a of the axial through hole 125, and the connecting portion 121 is matched with the shape of the distal end portion 125a, so that the connecting member 121 can only move axially relative to the second rotating member 122, and cannot rotate circumferentially.
  • the cross section of the connecting portion 121 is also rectangular.
  • the proximal end of the connecting duct 23 is received in the through hole of the second rotating member 122 through the connecting member 121. Referring again to FIG. 1, the outer portion of the second rotating member 122 is exposed outside the handle housing, and the operator can operate to rotate the second rotating member 122 to drive the connecting conduit 23 to rotate circumferentially.
  • the cross-sectional shape of the distal end portion 125a may also be a triangle, a diamond, a pentagon, an ellipse or the like, as long as the shape of the connecting member 121 matches the shape of the distal end portion 125a, so that the connecting member 121 It is only possible to move axially relative to the second rotating member 122, and it is not possible to rotate in the circumferential direction.
  • a second joint main body 33 for accommodating the proximal end of the push rod duct 22 is also coaxially disposed near the distal end of the second rotating member 122, and the connecting duct 23 penetrates the push rod duct 22 and also penetrates the second joint main body 33.
  • the fixing of the push rod guide is achieved by fixing the second joint main body 33 to the inner wall of the handle housing.
  • the second joint main body 33 is further provided with an opening communicating with the first valve 31 for use in flushing the inside of the conveying device 01.
  • the third actuating unit 13 is disposed at the proximal end of the conveying device 01, and specifically includes a third rotating member 131, an adjusting tube 132 screwed to the third rotating member 131, and a pushing duct 24.
  • the third rotating member 131 is disposed at the proximal end of the handle housing 50, has a hollow inner cavity and an inner wall, and has an internal thread on the inner wall.
  • the adjusting tube 132 is disposed in the inner cavity of the third rotating member 131 and is provided with an external thread that cooperates with the internal thread of the inner wall of the third rotating member 131.
  • the adjusting tube 132 is internally provided with an axial through hole communicating with the second valve 32.
  • the proximal end of the push catheter 24 extends from the distal end of the adjustment tube 132 into the axial through bore of the adjustment tube 132 and is secured within the adjustment tube 132; the distal end of the push catheter 24 is threaded through the proximal end of the second rotary member 12. It can be in contact with the proximal end surface of the connecting member 121.
  • the adjusting tube 132 can be moved toward the distal end, because the pushing catheter 24 is fixed relative to the adjusting tube 132, and the pushing catheter 24 is moved toward the distal end of the adjusting tube 132, and the distal end of the catheter 24 is pushed forward.
  • the pushing catheter 24 that continues to move distally can push the connecting catheter 23 to move distally, so that the distal end of the connecting catheter 23 is pushed from the push rod catheter
  • the distal end surface of 22 extends.
  • the third actuating unit 13 of the present invention can only actuate the connecting catheter 23 to move distally, unable to actuate the connecting catheter 23 to move proximally, but the third actuating unit 13 retracts to push the distal end of the catheter 24.
  • the connecting duct 23 can be moved toward the proximal end by an external force.
  • the second actuating unit 12 and the second joint body 33 are also respectively provided with a second sealing ring 40c and a third sealing ring 40b capable of functioning as a sealing and locking, respectively, and can respectively lock the pushing conduit 24 and the connecting conduit twenty three.
  • the pusher catheter may also be omitted, for example, the proximal end of the connecting catheter abuts the step of the adjusting tube having the stepped bore as long as the second adjusting member can drive the connecting catheter to move axially without affecting the connecting conduit The circumferential rotation can be.
  • the positional relationship of each of the conduits in the catheter assembly 20 of the delivery device 01 of the present invention is such that the distal end surface of the connection catheter 23 extends beyond the distal end surface of the push rod catheter 22, and the distal end surface of the push rod catheter 22 is located outside. Within the lumen of the sheath catheter 21, the distal end of the push catheter 24 is not in contact with the connector 121.
  • prosthetic heart valve implantation is performed using the delivery device 01 of the present invention, it is first necessary to load the prosthetic heart valve onto the delivery device 01.
  • first rotating the first rotating member 111 actuating the outer sheath catheter 21 to move proximally, exposing the distal end of the push rod catheter 22 from the distal end of the outer sheath catheter 21.
  • the prosthetic heart valve is then connected to the connecting catheter 23 by a threaded connection.
  • the first rotating member 111 is rotated again to move the sheath catheter 21 distally, and the connecting catheter 23 and the prosthetic heart valve are collectively collected into the lumen of the sheath catheter 21.
  • the force of the sheath catheter 21 to the prosthetic heart valve is indirectly transmitted to the connecting catheter 23, so that the connecting catheter 23 moves axially relative to the push rod catheter 22, and the moving connecting catheter 23 pushes the connecting member 121 and the pushing catheter.
  • the prosthetic heart valve After the prosthetic heart valve is delivered to the appropriate position by the delivery device 01, the prosthetic heart valve needs to be released. Specifically, first rotating the first rotating member 111, actuating the outer sheath catheter 21 to move toward the proximal end, undoing the binding force of the outer sheath catheter 21 on the artificial heart valve, and expanding the artificial heart valve. Then, the second rotating member 122 is rotated to drive the connecting catheter 23 to rotate circumferentially to release the artificial heart valve. Thereby the release of the prosthetic heart valve is completed.
  • the third rotating member 131 can be rotated such that the distal end of the connecting catheter 23 slightly extends beyond the distal end surface of the push rod catheter 22, thus releasing the artificial It is more convenient when the heart valve is used.
  • the prosthetic heart valve release position is poor or the valve is loaded in vitro
  • the prosthetic heart valve needs to be reconnected to the connecting catheter, the third rotating member 131 can be rotated, and the connecting catheter 23 can be pushed to the distal end by the pushing catheter 24, and the connecting catheter 23 is set.
  • the distal end of the threaded structure is exposed from the distal end of the push rod catheter 22.
  • the third rotating member 131 is rotated again to partially withdraw the pusher catheter 24, that is, the distal end of the pusher catheter 24 is no longer in contact with the connecting member 121.
  • the connection of the prosthetic heart valve to the connecting catheter 23 is performed.
  • the third actuation unit may be omitted if it is not necessary to repeatedly release and recover the prosthetic heart valve.
  • the distal end of the push rod catheter can also be arranged in a tapered configuration with the taper angle of the tapered structure facing the distal end.
  • a design can reattach the prosthetic heart valve to the connecting catheter by the engagement of the actuation assembly when the prosthetic heart valve is released but the position is not ideal, and the position is adjusted and then released.
  • the tapered structure at the distal end of the push rod catheter mainly functions as a puncture, so that the re-piercing is not required, and the position of the artificial heart valve can be adjusted in time, which greatly saves the operation time when the position of the heart valve is not released well.
  • FIG. 10a to FIG. 10g which also shows the basic anatomy of the human heart, including the left atrium LA, the left ventricle LV, the left atrium RA, and the right ventricle RV.
  • the micro-incision is first cut in the fifth or sixth intercostal space of the left front chest, the pericardium is opened longitudinally through the incision and sutured to expose the apex, and then the apical pouch 310 is sutured near the apex. As shown in Figure 10a.
  • a soft guide wire 320 is inserted forward into the left ventricle of the heart, as shown in Fig. 10b.
  • the puncture needle is then withdrawn and fed along the guidewire 320 into the distal pre-shaped short sheath tube 330 and the distal end dilator tube 340 with the balloon 341, wherein the guide wire 320 is located within the dilator tube 340, the dilator tube 340 is located within the short sheath tube 330, as shown in Figure 10c, and further the distal end of the short sheath tube 330 or dilator tube 340 or both may be provided with a development ring 350.
  • the balloon 341 is expanded and filled (as shown in Fig. 10d), and the shape after expansion is spherical or elliptical, and the maximum outer diameter is between 8 and 15 mm, so as to avoid interference of the cable to the approach during the subsequent operation.
  • the guidewire 320 reaches the left atrium through the mitral valve to establish an extracorporeal to left atrium orbit.
  • the guidewire 320 in the left atrium is then retained, the short sheath tube 330 and the dilator tube 340 are withdrawn, then inserted into the apical dilation device 360 along the guidewire 320, the apical puncture site is gradually dilated through the apical dilation tube 361, and the apex dilated outer catheter 362 is expanded.
  • the distal end is delivered into the left ventricle as shown in Figure 10e.
  • the apical dilatation tube 361 is withdrawn, leaving the apical dilatation outer catheter 362 in the heart.
  • the catheter assembly 20 of the delivery device 01 is delivered to the heart along the guidewire 320, and the distal end of the sheath catheter 21 passes through the mitral valve such that the development ring 211 of the sheath catheter 21 is parallel to the mitral valve, on the same level.
  • the first rotating member 111 is rotated to withdraw the sheath catheter 21 proximally, thereby removing a portion of the radial binding force to the distal end of the prosthetic heart valve, and the proximal portion of the prosthetic heart valve is still in the recovery catheter 22. Inside the lumen, as shown in Figure 10f. The first rotating member 111 is continuously rotated in the same direction.
  • the artificial heart valve As the sheath catheter 21 is further withdrawn, the artificial heart valve is self-expanding radially outward.
  • the third rotating member 131 When the artificial heart valve integrally exposes the outer sheath catheter 21, the third rotating member 131 is rotated.
  • the distal end of the connecting catheter 23 is exposed to the distal end of the push rod catheter 22, as shown in Figure 10g.
  • the second rotating member 122 is rotated, so that the connecting catheter 23 also rotates, thereby releasing the screw connection of the connecting catheter 23 and the artificial heart valve, completing the final release of the prosthetic heart valve.
  • the delivery device 01 When the artificial heart valve is loaded, the delivery device 01 firstly passes the tether extending from the proximal end of the prosthetic valve into the connecting catheter 23, and the proximal end of the tether is extended from the proximal end of the connecting catheter 23, and then the third rotation is rotated.
  • the rotating member 131 pushes the catheter 24 axially distally to push the connecting member 121 such that the distal end of the connecting catheter 23 exposes the distal end of the push rod catheter 22, and the distal end of the connecting catheter 23 is screwed with the prosthetic heart valve. Assembly. After the assembly is completed, the third rotating member 131 is rotated back to the initial position, so that the pusher catheter 24 is retracted away from the connecting member 121.
  • the first rotating member 111 is rotated to move the sheath catheter 21 distally, and the artificial heart valve will gradually be absorbed into the sheath catheter 21.
  • the force of the sheath catheter 21 to the prosthetic heart valve is indirectly transmitted to the connecting catheter 23, so that the connecting catheter 23 moves axially relative to the push rod catheter 22, and the moving connecting catheter 23 pushes the connecting member 121 and the pushing catheter.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Un appareil de déploiement de dispositif médical (01), comprenant un tube de cathéter (20) creux, et un actionneur (10) connecté au tube de cathéter (20). Le tube de cathéter (20) comprend un cathéter à gaine externe (21), et un cathéter de raccordement (23) s'étendant à travers le cathéter à gaine externe (21). L'actionneur (10) comprend, de l'extrémité distale à l'extrémité proximale, une première unité d'actionneur (11) et une deuxième unité d'actionneur (12) disposées axialement. La première unité d'actionneur (11) est connectée au cathéter à gaine externe (21) et actionne le cathéter à gaine externe (21). La deuxième unité d'actionneur (12) est connectée au cathéter de raccordement (23) pour faire tourner le cathéter de raccordement (23). L'appareil de déploiement de dispositif médical (01) permet de commander le tube de cathéter (20) par l'intermédiaire de l'actionneur (10). En particulier, la première unité d'actionneur (11) convertit la rotation de celle-ci en un mouvement axial du cathéter à gaine externe (21), ce qui permet d'économiser du temps et de l'effort lors de l'implantation d'un dispositif médical.
PCT/CN2018/119276 2017-12-29 2018-12-05 Appareil de déploiement de dispositif médical WO2019128653A1 (fr)

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CN201711479996.9A CN109984867B (zh) 2017-12-29 2017-12-29 医疗器械输送装置
CN201711479996.9 2017-12-29

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CN112472233B (zh) * 2020-11-23 2022-03-11 上海微创医疗机器人（集团）股份有限公司 器械切换机构、器械连接机构、手术器械及单孔操作系统
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CN114305799B (zh) * 2021-12-15 2023-07-07 上海汇禾医疗科技股份有限公司 一种医疗器械植入单元

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