WO2019128653A1 - 医疗器械输送装置 - Google Patents

医疗器械输送装置 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
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/CN2018/119276
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English (en)
French (fr)
Inventor
江巍
谢惠雄
王刚
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lifetech Scientific Shenzhen Co Ltd
Original Assignee
Lifetech Scientific Shenzhen Co Ltd
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Filing date
Publication date
Application filed by Lifetech Scientific Shenzhen Co Ltd filed Critical Lifetech Scientific Shenzhen Co Ltd
Publication of WO2019128653A1 publication Critical patent/WO2019128653A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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.

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Abstract

一种医疗器械输送装置（01），包括中空的导管组件（20）和与该导管组件（20）相连的致动组件（10）；该导管组件（20）包括外鞘导管（21）和贯穿该外鞘导管（21）的连接导管（23）；该致动组件（10）包括由远端至近端轴向设置的第一致动单元（11）和第二致动单元（12），该第一致动单元（11）与该外鞘导管（21）相连且致动该外鞘导管（21），该第二致动单元（12）与该连接导管（23）相连,以驱动该连接导管（23）旋转。该医疗器械输送装置（01）通过致动组件（10）实现对导管组件（20）的控制，尤其是第一致动单元（11）将自身的周向转动转换成外鞘导管（21）的轴向移动，使得医疗器械的植入更加方便省力。

Description

医疗器械输送装置 技术领域
本发明涉及介入医疗器械领域，具体涉及一种医疗器械输送装置。
背景技术
人体的心脏分为四个腔室，每个腔室都有各自的“出口”，共有四个瓣膜(二尖瓣、主动脉瓣、肺动脉瓣和三尖瓣)，它们确保由心脏泵送的血液在心血管系统中按照指定的方向流过。二尖瓣位于左心房和左心室之间，正常的二尖瓣保证血液循环由左心房一定向左心室方向流动和通过一定的血流量。另外当左心室收缩时，二尖瓣的两片柔性小叶闭合，可防止血液从心脏的左心室向左心房回流。各种心脏疾病或退行性病变均可能导致二尖瓣功能障碍，使得二尖瓣变得异常缩窄或扩张，或者允许血液从左心室返流回左心房中。二尖瓣功能的缺失损伤，会影响心脏的正常工作，致使人逐渐衰弱或危及生命。
针对二尖瓣功能的障碍，存在多种治疗的方法，如传统的瓣膜置换手术，被认为是“开放心脏”手术。简而言之，手术需要手术打开胸部，用心肺机启动体外循环，打开心脏，切除和更换患者的二尖瓣，但由于体外循坏的操作复杂和老年患者的耐受性差，“开放心脏”手术存在较高死亡风险。目前，通过介入的手段进行二尖瓣功能障碍的治疗方法逐渐被人们所关注，且已开发出用于递送置换二尖瓣的创伤较小的经导管技术。在此类技术中，自彭式假体瓣膜一般以卷曲状态安装在柔性导管的末端并经患者的血管或身体推进，直至该假体瓣膜 抵达植入部位。继而假体瓣膜在有缺陷的天然二尖瓣膜的部位处扩张至其功能尺寸。
虽然经导管介入技术置换天然二尖瓣膜是治疗功能不全的有效方法，但假体瓣膜的体积往往较大，在输送装置中递送存在较大难度；若增大输送导管的尺寸，对患者心脏的损伤也会相应增加。此外现有系统和方法的置换过程系统操控复杂，较容易损伤心脏组织从而导致治疗效果不佳。因此，期望提供用于治疗瓣膜功能不全，比如治疗二尖瓣功能不全的改进的装置和方法，需要一个合适的假体瓣膜的递送装置，输送假体瓣膜到达目标位置和释放，要求输送器的操作简单，假体瓣膜的释放力小，便于医生的操作。
发明内容
本发明提供了一种医疗器械输送装置，包括中空的导管组件和与所述导管组件相连的致动组件；所述导管组件包括外鞘导管和贯穿所述外鞘导管的连接导管；所述致动组件包括由远端至近端轴向设置的第一致动单元和第二致动单元，所述第一致动单元与所述外鞘导管相连且致动所述外鞘导管，所述第二致动单元与所述连接导管相连,以驱动所述连接导管旋转。
在一实施例中，所述第一致动单元包括第一旋转件和固定件，所述第一旋转件具有内腔，所述固定件收容于所述第一旋转件的内腔内，所述固定件与所述外鞘导管近端相连，周向转动的所述第一旋转件带动所述固定件及外鞘导管相对所述第一旋转件轴向移动。
在一实施例中，所第一旋转件的内壁上设有绕所述第一旋转件轴 向旋转的螺旋状导向槽，所述固定件包括第一接头主体及设于所述第一接头主体侧壁上的滚动件，所述第一接头主体的侧壁设有用于收容所述滚动件的收容凹槽，所述滚动件夹设在所述导向槽和收容凹槽之间，所述第一接头主体与所述外鞘导管近端相连。
在一实施例中，所述导向槽的螺旋角度范围为15度至45度。
在一实施例中，所述第一致动单元还包括导向件，所述导向件设于所述第一旋转件与所述固定件之间，所述导向件具有内腔和侧壁，所述侧壁上设有与所述导向件的内腔相通的轴向限位开口，所述限位开口限定所述固定件轴向移动的路径。
在一实施例中，所述第二致动单元包括第二旋转件，所述第二旋转件与所述连接导管近端相连，所述第二旋转件周向转动时带动所述连接导管仅周向转动。
在一实施例中，所述致动组件还包括第三致动单元，所述第三致动单元设于所述第二致动单元的近端，所述第三致动单元包括第三旋转件及与所述第三旋转件螺接的中空的调节管，当所述调节管的远端与所述连接导管相接触时，旋转的第三旋转件驱动调节管带动所述连接导管向远端移动。
在一实施例中，所述第三致动单元还包括中空的推动导管，所述推动导管的近端固设在所述调节管上，且所述推动导管的管腔与所述调节管的管腔相连通。
在一实施例中，所述导管组件还包括推杆导管，所述推杆导管贯穿所述外鞘导管，所述连接导管贯穿所述推杆导管。
在一实施例中，所述推杆导管的远端为锥形结构。
在一实施例中，所述输送装置还包括手柄壳体，所述第一致动单元、第二致动单元和第三致动单元在所述手柄壳体内轴向设置。
在一实施例中，所述连接导管远端设有螺纹结构，所述连接导管通过所述螺纹结构与医疗器械连接。
本发明提供的医疗器械输送装置，包括导管组件和包含两个致动单元的致动组件。导管组件包括外鞘导管和连接导管，连接导管与医疗器械相连，外鞘导管收容医疗器械。通过第一致动单元控制外鞘导管的轴向运动以实现对医疗器械的收容与释放；第二致动单元转动控制医疗器械的最终释放。通过致动组件实现对导管组件的控制，尤其是第一致动单元将自身的周向转动转换成外鞘导管的轴向移动，使得医疗器械的植入更加方便省力。
附图说明
图1为本发明实施例的医疗器械输送装置结构示意图；
图2为本发明实施例的医疗器械输送装置截面结构示意图；
图3为本发明实施例的医疗器械输送装置部分拆分结构示意图；
图4为本发明实施例的医疗器械输送装置的第一旋转件结构示意图；
图5为图4所示第一旋转件的截面结构示意图；
图6为本发明实施例的医疗器械输送装置的导向件结构示意图；
图7a为本发明实施例的医疗器械输送装置第一致动单元截面结构示意图；
图7b为图7a部分结构放大图；
图8为本发明实施例的医疗器械输送装置第二致动单元和第三致动单元结构示意图；
图9为图8所示结构的截面结构示意图；
图10a至图10g为利用本发明的输送装置进行人工心脏瓣膜植入的操作过程示意图。
具体实施方式
为更好地理解本发明的技术方案和有益效果，以下结合具体实施例对本发明做进一步的详细说明。在介入医疗领域，定义距离器械操作者近的一端为“近端”，距离器械操作者远的一端为“远端”；定义平行于器械近端中心与远端中心连线的方向为“轴向”，垂直该“轴向”的方向为“径向”，环绕该“轴向”的方向为“周向”。“连接”可以是两物件直接相连接，也可以是通过其它的物件实现连接。
本发明的医疗器械输送装置可用于多种医疗器械的输送，如滤器、封堵器或人工心脏瓣膜等，具体选用时选择合适的导管组件的外径尺寸的输送装置即可。下面以输送人工心脏瓣膜为例对本发明的输送装置做详细说明。
参见图1至图3，本发明的医疗器械输送装置01包括致动组件10和中空的导管组件20。导管组件20的近端与致动单元10的远端相连，致动组件10可致动导管组件20。
致动组件10包括由远端至近端轴向依次设置的第一致动单元11、第二致动单元12和第三致动单元13。导管组件20包括同轴设置的外 鞘导管21、推杆导管22和连接导管23。外鞘导管21、推杆导管22和连接导管23中的每一个导管均为中空结构且两端具有开口。其中，推杆导管22贯穿外鞘导管21，连接导管23贯穿推杆导管22，连接导管23的内腔可供导丝穿过。推杆导管22与连接导管23以及推杆导管22与外鞘导管21之间均存在间隙，方便导管之间相对运动。外鞘导管21的近端与第一致动单元11连接，第一致动单元11致动外鞘导管21产生轴向运动。第二致动单元12与连接导管23近端连接，以致动连接导管23产生周向转动。第三致动单元13与连接导管23近端端面相抵，以致动连接导管23产生轴向运动。同时，连接导管23远端还设有螺纹结构(图未标)，连接导管23能通过该螺纹结构实现与人工心脏瓣膜的连接或解脱。
外鞘导管21提供足够的支撑力用于人工心脏瓣膜的输送，其材料可以为单层高分子材料、金属或高分子材料与金属的复合材料，如可选为PEEK、PC、POM、钛或PTFE+不锈钢+PEBAX/尼龙的复合材料等。推杆导管22用于为装载至输送装置01上的人工心脏瓣膜的近端提供轴向的支撑力以及释放心脏瓣膜时的轴向推力，材料可为单层高分子材料，如可选为PE、PC、PEBAX或尼龙等。连接导管23用于连接人工心脏瓣膜，材料可为高分子材料或金属，如可选为PEEK、不锈钢、镍钛或钛等。
外鞘导管21的远端还设有显影环211，显影环211可以在影像设备下成像，指示输送装置01在体内的输送位置。显影环211的材料可以为铂、钽或钨等具有较好显影特性的金属材料。
输送装置01还包括手柄壳体50。手柄壳体50包括可拆解的远端手柄壳体51和近端手柄壳体52。远端手柄壳体51包括远端第一半壳511和远端第二半壳512。远端第一半壳511和远端第二半壳512之间可以通过卡扣连接组装成远端手柄壳体51，也可以通过螺丝和螺母连接、粘接或焊接等方式组装成远端手柄壳体51。近端手柄壳体52包括近端第一半壳521和近端第二半壳522。近端第一半壳521和近端第二半壳522之间可以通过卡扣连接组装成近端手柄壳体52，也可以通过螺丝和螺母连接、粘接或焊接等方式组装成近端手柄壳体52。手柄壳体50用于提供收容和固定作用，将致动组件10收容组装并固定。第一致动单元11、第二致动单元12和第三致动单元13在手柄壳体50内轴向排列设置。其中，第一致动单元11和第二致动单元12均设于手柄壳体50的中部，第三致动单元13靠近手柄壳体50的近端。手柄壳体50上还设有第一阀31和第二阀32，第一阀31和第二阀32均优选为鲁尔接头。其中第一阀31与注射器连接后可对推杆导管22内腔进行冲洗，从推杆导管22远端流出的冲洗液可对外鞘导管21远端进行局部冲洗，第二阀32与注射器连接后可对连接导管23的内腔进行冲洗。
同时参见图4至图7，第一致动单元11包括第一旋转件111、导向件112和固定件113。其中，第一旋转件111为具有中空内腔和内壁的管状结构，包括相连且可同时旋转的近端旋转部111a和远端旋转部111b。其中，近端旋转部111a设于远端手柄壳体51和近端手柄壳体52之间，远端旋转部111b设于远端手柄壳体51内，即操作者 可以操作近端旋转部111a旋转，从而带动远端旋转部111b旋转。第一旋转件111的内壁上还设有导向槽111c。导向槽111c为螺旋状，环绕第一旋转件111的轴向旋转设置，螺旋角度的范围可为15～45°，本实施例优选为18°。导向件112设于第一旋转件111的内腔内，且具有内腔和侧壁112a。侧壁112a上还设有与导向件112的内腔相通的轴向的限位开口112b。导向件112的近端可在手柄壳体50内固定，保证第一致动单元11致动外鞘导管21时，导向件112相对第一旋转件111无轴向移动。固定件113部分设于导向件112的内腔内且可相对导向件112轴向移动。固定件113包括第一接头主体113a。第一接头主体113a近端卡设于限位开口112b内，从而保证固定件113相对于导向件112仅发生轴向移动而不产生周向转动。第一接头主体113a的远端设有可收容外鞘导管21近端的远端开口，在本实施例中，第一接头主体113a远端的开口与外鞘导管21的近端通过螺纹连接。可以理解的是，在其它实施例中，第一接头主体与外鞘导管的近端还可以通过卡接、粘接或焊接等其它方式连接。
进一步地，固定件113还包括调节件113b和设于调节件113b远端的第一密封圈40a。第一接头主体113a近端还设有收容调节件113b和第一密封圈40a的近端开口，该第一接头主体113a的近端开口与远端开口连通，推杆导管22通过该第一接头主体113a的近端开口和远端开口贯穿第一接头主体113a的内部。调节件113b上设有外螺纹，第一接头主体113a的近端开口内设有与调节件113b上外螺纹配合的内螺纹。在装配输送装置01的导管组件20以及致动组件10时，通 过调节调节件113b可挤压第一密封圈40a变形，实现密封外鞘导管21和推杆导管22之间间隙的目的。
第一接头主体113a的近端外侧还设有半球形收容凹槽113c，收容凹槽113c内设有滚动件114。滚动件114具体设于第一接头主体113a与第一旋转件111的内壁上的导向槽111c之间。滚动件114为球形，直径与导向槽111c的宽度匹配，从而限制滚动件114在导向槽113c内滚动但不会从收容凹槽113c内脱落。滚动件114的数量至少为1个，本实施例优选为2个且对称设置，同时导向槽111c的数量不少于滚动件114的数量，本实施例导向槽111c的数量亦为2个。可以理解是，其它实施例中，收容凹槽还可以为四分之一球形凹槽、三分之一球形凹槽、五分之一球形凹槽等。其中，四分之一球形凹槽指的是，在中空的球形结构的四分之一直径处，沿垂直于该直径的方向切割该球形结构后获得的与四分之一直径对应的凹槽。三分之一球形凹槽、五分之一球形凹槽与四分之一球形凹槽定义方法类似，在此不再赘述。
当手动转动第一旋转件111时，会带动滚动件114滚动，由于第一旋转件111被手柄壳体限制了只能周向转动，而导向件112又限制固定件113只发生轴向移动。因此滚动件114的滚动将带动固定件113轴向移动，从而带动与固定件113连接的外鞘导管21的轴向运动。通过导向件112将第一旋转件111的周向转动转变成外鞘导管21的轴向运动，使得外鞘导管沿轴向运动的力大大减小，同时缩短了输送装置01的整体轴向尺寸。
在其它实施例中，也可省略导向件，例如通过在手柄壳体内设置限位条，保证固定件不会相对于手柄壳体发生周向转动即可。
同时参阅图8和图9，第二致动单元12包括第二旋转件122和与连接导管23相连的连接件121。第二旋转件122具有呈台阶状的轴向通孔125，且远端设有能收容连接导管23的开口。轴向通孔125包括孔径较大的远端部125a和孔径较小的近端部125b。优选地，本实施例中，远端部125a的横截面为矩形。连接件121位于轴向通孔125的远端部125a，且连接部121与远端部125a的形状相匹配，使得连接件121相对第二旋转件122仅能轴向移动，而无法周向转动。本实施例中，连接部121的截面也为矩形。连接导管23的近端通过连接件121收容于第二旋转件122的通孔内。再次参阅图1，第二旋转件122的外侧部分外露于手柄壳体外，操作者可以操作转动第二旋转件122，从而带动连接导管23周向转动。可以理解的是，其它实施例中，远端部125a的截面形状也可以为三角形、菱形、五边形、椭圆形等，只要连接件121与远端部125a的形状相匹配，使得连接件121相对第二旋转件122仅能轴向移动，而无法周向转动即可。
靠近第二旋转件122的远端还同轴设有用于收容推杆导管22近端的第二接头主体33，且连接导管23贯穿推杆导管22的同时也贯穿第二接头主体33。通过将第二接头主体33固定于手柄壳体内壁实现对推杆导管的固定。第二接头主体33上还设有与第一阀31相通的开口，供冲洗输送装置01内部时使用。
第三致动单元13设于输送装置01的最近端，具体包括第三旋转 件131、与第三旋转件131螺接的调节管132以及推动导管24。第三旋转件131设于手柄壳体50的近端端部，具有中空内腔和内壁，且内壁上设有内螺纹。调节管132穿设于第三旋转件131的内腔内，且设有与第三旋转件131内壁的内螺纹相配合的外螺纹。调节管132内部设有轴向通孔，该轴向通孔与第二阀32相通。推动导管24的近端从调节管132的远端穿至调节管132的轴向通孔内，且固定于调节管132内；推动导管24的远端从第二旋转件12的近端开口穿入且可与连接件121近端端面相抵。通过转动第三旋转件131，可以带动调节管132朝向远端移动，因推动导管24相对于调节管132固定，推动导管24随调节管132朝向远端的移动，待推动导管24的远端抵接连接件121的近端，继续同向旋转第三旋转件131，则继续向远端移动的推动导管24即可推动连接导管23向远端移动，使得连接导管23的远端从推杆导管22的远端端面伸出。应当注意，本发明的第三致动单元13只能致动连接导管23向远端移动，不能致动连接导管23向近端移动，但第三致动单元13回撤使推动导管24远端与连接件121不接触时，连接导管23可在外力的作用下朝向近端移动。
优选地，第二致动单元12和第二接头主体33内也分别设有能起到密封锁紧作用的第二密封圈40c和第三密封圈40b，能分别锁紧推动导管24和连接导管23。
在其它实施例中，也可以省略推动导管，例如连接导管的近端段与具有台阶孔的调节管的台阶处抵接，只要第二调节件可以驱动连接导管轴向移动，且不影响连接导管的周向转动即可。
综上，以下具体阐述本发明的输送装置01的使用方法。初始状态下，本发明的输送装置01的导管组件20中各导管的位置关系为：连接导管23的远端端面伸出推杆导管22的远端端面，推杆导管22的远端端面位于外鞘导管21的内腔内，推动导管24远端与连接件121不接触。在使用本发明的输送装置01进行人工心脏瓣膜植入时，首先需要将人工心脏瓣膜装载至输送装置01上。具体地，首先转动第一旋转件111，致动外鞘导管21向近端移动，使推杆导管22的远端从外鞘导管21的远端露出。再通过螺纹连接将人工心脏瓣膜连接至连接导管23上。最后再次转动第一旋转件111，使外鞘导管21向远端移动，将连接导管23和人工心脏瓣膜一并收至外鞘导管21的内腔内。此时，外鞘导管21对人工心脏瓣膜的力间接地传递给连接导管23，使得连接导管23相对推杆导管22朝向近端作轴向运动，移动的连接导管23推动连接件121与推动导管24远端端面相抵，连接导管23的远端再次退回至推杆导管22的内腔内，从而完成人工心脏瓣膜的装载。
通过输送装置01将人工心脏瓣膜输送至合适位置后，需要对人工心脏瓣膜进行释放。具体地，首先转动第一旋转件111，致动外鞘导管21朝向近端移动，撤消外鞘导管21对人工心脏瓣膜的束缚力，使人工心脏瓣膜扩张。然后转动第二旋转件122，带动连接导管23周向转动，释放人工心脏瓣膜。从而完成人工心脏瓣膜的释放。可以理解的是，如有需要，可以在转动第二旋转件122释放人工心脏瓣膜前，转动第三旋转件131使得连接导管23的远端稍伸出推杆导管22远端 端面，这样释放人工心脏瓣膜的时候更加方便。
当人工心脏瓣膜释放位置不佳或在体外装载瓣膜需要重新将人工心脏瓣膜连接至连接导管时，可以转动第三旋转件131，利用推动导管24推动连接导管23向远端运动，连接导管23设有螺纹结构的远端从推杆导管22的远端露出。再次转动第三旋转件131，使推动导管24部分回撤，即推动导管24的远端不再与连接件121相抵。再进行人工心脏瓣膜与连接导管23的连接。因此，可以理解的是，在其它实施例中，若无需反复释放和回收人工心脏瓣膜，则可以省略第三致动单元。
进一步地，在其它实施例中，还可以将推杆导管的远端设置成锥形结构，锥形结构的锥角朝向远端。这样的设计可以在释放人工心脏瓣膜但位置不理想时通过致动组件的配合重新将人工心脏瓣膜连接至连接导管上，调整位置后重新释放。此时，推杆导管远端的锥形结构主要起到穿刺的作用，这样不需要重新穿刺，能及时调整人工心脏瓣膜的位置，大大节省了心脏瓣膜位置释放不佳时的手术时间。
具体以将人工心脏瓣膜植入人体心脏为例说明本发明的输送装置01的使用方法。请同时参阅图10a至图10g，图中同时示出了人体心脏的基本解剖结构，包括左心房LA、左心室LV、左心房RA和右心室RV。在使用本发明的输送装置01前，首先在左前侧胸部第五或者第六肋间隙切开微切口，经切口纵向打开心包并缝合后暴露出心尖，接着在靠近心尖部进行心尖荷包310缝合，如图10a所示。接着，使用穿刺针对心尖进行穿刺，向前插入一根软导丝320进入心脏左心室， 如图10b所示。随后撤出穿刺针，沿着导丝320送入远端预塑形的短鞘管330和远端带球囊341的扩张器管340，其中导丝320位于扩张器管340内，扩张器管340位于短鞘管330内，如图10c所示，此外短鞘管330或扩张器管340的远端或者两者的远端均可设显影环350。然后，使球囊341扩张充盈(如图10d)，扩张后的形状为球型或者椭圆型，最大外径在8-15mm之间，避免后续操作过程中，腱索对入路的干扰。紧接着，在DSA和超声的辅助下，导丝320经二尖瓣到达左心房，建立体外到左心房的轨道。然后保留位于左心房的导丝320，撤出短鞘管330和扩张器管340，接着沿导丝320插入心尖扩张装置360，通过心尖扩张管361逐渐扩张心尖穿刺点，将心尖扩张外导管362的远端送入到左心室内，如图10e所示。接着，撤出心尖扩张管361，使心尖扩张外导管362保留在心脏内。将输送装置01的导管组件20沿导丝320递送至心脏，外鞘导管21的远端穿过二尖瓣，使得外鞘导管21的显影环211与二尖瓣相平行，位同一水平面上。当位置确认无误后，旋转第一旋转件111，向近端收回外鞘导管21，从而移除对人工心脏瓣膜远端的部分径向约束力，人工心脏瓣膜近端部分仍在回收导管22的内腔内，如图10f所示。继续向相同方向转动第一旋转件111，随着外鞘导管21被进一步回撤，人工心脏瓣膜径向向外自扩张，当人工心脏瓣膜整体露出外鞘导管21后，旋转第三旋转件131，将连接导管23的远端露出推杆导管22的远端，如图10g所示。此时旋转第二旋转件122，使得连接导管23也随着转动，从而使连接导管23与人工心脏瓣膜的螺纹连接解脱，完成人工心脏瓣膜的 最终释放。
输送装置01在装载人工心脏瓣膜时，首先将假体瓣膜近端延伸出的系绳穿入到连接导管23内，系绳近端再从连接导管23的近端伸出，接着旋转第三旋旋转件131，推动导管24沿轴向向远端位移，推动连接件121，使得连接导管23的远端露出推杆导管22的远端，连接导管23的远端螺纹与人工心脏瓣膜进行螺纹连接组装。组装完成后，旋转第三旋转件131回初始位置，使得推动导管24后撤，远离连接件121。此时旋转第一旋转件111，将外鞘导管21向远端移动，人工心脏瓣膜将会逐渐收入到外鞘导管21中。此时由于外鞘导管21对人工心脏瓣膜的力间接地传递给连接导管23，使得连接导管23相对推杆导管22朝向近端作轴向运动，移动的连接导管23推动连接件121与推动导管24远端端面相抵，连接导管23的远端再次退回至推杆导管22的内腔内，从而完成人工心脏瓣膜的装载。
以上实施例仅为本发明的优选实施方式，无法对所有可选方式进行一一列举，因此不能认为以上实施方式是对本发明的限制。同时，本领域的技术人员可以根据实际需求对相应的部分结构或连接方式进行简单更改和替换，本发明的保护范围以权利要求为准。

Claims (12)

  1. 一种医疗器械输送装置，其特征在于，包括中空的导管组件和与所述导管组件相连的致动组件；所述导管组件包括外鞘导管和贯穿所述外鞘导管的连接导管；所述致动组件包括由远端至近端轴向设置的第一致动单元和第二致动单元，所述第一致动单元与所述外鞘导管相连且致动所述外鞘导管，所述第二致动单元与所述连接导管相连,以驱动所述连接导管旋转。
  2. 根据权利要求1所述的医疗器械输送装置，其特征在于，所述第一致动单元包括第一旋转件和固定件，所述第一旋转件具有内腔，所述固定件收容于所述第一旋转件的内腔内，所述固定件与所述外鞘导管近端相连，周向转动的所述第一旋转件带动所述固定件及外鞘导管相对所述第一旋转件轴向移动。
  3. 根据权利要求2所述的医疗器械输送装置，其特征在于，所第一旋转件的内壁上设有绕所述第一旋转件轴向旋转的螺旋状导向槽，所述固定件包括第一接头主体及设于所述第一接头主体侧壁上的滚动件，所述第一接头主体的侧壁设有用于收容所述滚动件的收容凹槽，所述滚动件夹设在所述导向槽和收容凹槽之间，所述第一接头主体与所述外鞘导管近端相连。
  4. 根据权利要求3所述的医疗器械输送装置，其特征在于，所述导向槽的螺旋角度范围为15度至45度。
  5. 根据权利要求2所述的医疗器械输送装置，其特征在于，所述第一致动单元还包括导向件，所述导向件设于所述第一旋转件与所 述固定件之间，所述导向件具有内腔和侧壁，所述侧壁上设有与所述导向件的内腔相通的轴向限位开口，所述限位开口限定所述固定件轴向移动的路径。
  6. 根据权利要求1所述的医疗器械输送装置，其特征在于，所述第二致动单元包括第二旋转件，所述第二旋转件与所述连接导管近端相连，所述第二旋转件周向转动时带动所述连接导管仅周向转动。
  7. 根据权利要求1所述的医疗器械输送装置，其特征在于，所述致动组件还包括第三致动单元，所述第三致动单元设于所述第二致动单元的近端，所述第三致动单元包括第三旋转件及与所述第三旋转件螺接的中空的调节管，当所述调节管的远端与所述连接导管相接触时，旋转的第三旋转件驱动调节管带动所述连接导管向远端移动。
  8. 根据权利要求7所述的医疗器械输送装置，其特征在于，所述第三致动单元还包括中空的推动导管，所述推动导管的近端固设在所述调节管上，且所述推动导管的管腔与所述调节管的管腔相连通。
  9. 根据权利要求1所述的医疗器械输送装置，其特征在于，所述导管组件还包括推杆导管，所述推杆导管贯穿所述外鞘导管，所述连接导管贯穿所述推杆导管。
  10. 根据权利要求9所述的医疗器械输送装置，其特征在于，所述推杆导管的远端为锥形结构。
  11. 根据权利要求1至10中任一项所述的医疗器械输送装置，其特征在于，所述输送装置还包括手柄壳体，所述第一致动单元、第二致动单元和第三致动单元在所述手柄壳体内轴向设置。
  12. 根据权利要求1至10中任一项所述的医疗器械输送装置，其特征在于，所述连接导管远端设有螺纹结构，所述连接导管通过所述螺纹结构与医疗器械连接。
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