WO2019128702A1 - Medical instrument delivery apparatus - Google Patents
Medical instrument delivery apparatus Download PDFInfo
- Publication number
- WO2019128702A1 WO2019128702A1 PCT/CN2018/120322 CN2018120322W WO2019128702A1 WO 2019128702 A1 WO2019128702 A1 WO 2019128702A1 CN 2018120322 W CN2018120322 W CN 2018120322W WO 2019128702 A1 WO2019128702 A1 WO 2019128702A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- catheter
- delivery device
- conduit
- rotating member
- recovery
- Prior art date
Links
Images
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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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.
- conventional valve replacement surgery which is considered an "open heart” procedure.
- the surgery needs to open the chest, start the extracorporeal circulation with the cardiopulmonary machine, open the heart, remove and replace the patient's mitral valve, but due to the complicated operation in vitro and the poor tolerance of elderly patients, "open heart” surgery There is a high risk of death.
- the treatment of mitral dysfunction by 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 a 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 the treatment of dysfunction, due to the complex anatomy of the mitral valve complex and the increased intraluminal pressure caused by ventricular contraction, the release position of the prosthetic valve may be unsatisfactory or in blood.
- the release under the impact of the flow is displaced and needs to be recovered and re-released.
- the valve delivery device is difficult to recover the artificial heart valve, and additional devices need to be used together, resulting in complicated operation, increased operation time, and increased surgical risk.
- the existing delivery system and the valve replacement method are complicated in operation, and are easy to damage the heart tissue, resulting in poor therapeutic effect. Accordingly, it is desirable to provide improved delivery devices and methods for treating valvular insufficiency, such as for the treatment of mitral regurgitation, which enable easy loading release of the prosthetic heart valve and recovery adjustment and re-release when the release position is poor.
- 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, a recovery conduit extending through the outer sheath catheter, and through Retracting a connecting conduit of the catheter; the actuation assembly including a first actuation unit, a second actuation unit, and a third actuation unit disposed axially from the distal end to the proximal end, the first actuation unit and the first actuation unit An outer sheath conduit is coupled to actuate the outer sheath conduit, the second actuation unit is coupled to the recovery conduit and actuates the recovery conduit, the third actuation unit is coupled to the connection conduit and actuated The connecting conduit.
- 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 body and the fixing member, the guiding member having a 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 includes a second rotating member and a connecting member, the second rotating member has a through hole, the connecting member is disposed in the through hole, and the connecting member is The recovery duct is connected at a proximal end, and the second rotating member rotates in the circumferential direction to drive the recovery duct to move axially.
- the second actuating unit further includes a limiting member disposed at a proximal end of the connecting member for limiting a distance at which the recovery conduit moves distally.
- the third actuating unit includes a third rotating member, the third rotating member is coupled to the connecting conduit, and the third rotating member rotates circumferentially to rotate the connecting conduit. .
- the conveying device further includes a handle housing, from the distal end to the proximal end, the first actuation unit, the second actuation unit and the third actuation unit are sequentially disposed in the handle housing .
- the distal end of the connecting catheter is provided with a threaded structure.
- the distal end of the recovery catheter is provided with a horn structure or a deformable wave structure.
- the medical device delivery device provided by the invention can realize easy loading and release of the medical device and recovery adjustment and re-release when the release position is not good.
- FIG. 1 is a schematic structural view of a medical device delivery device according to an embodiment of the present invention.
- Figure 2 is a cross-sectional structural view of the medical device delivery device shown in Figure 1;
- FIG. 3 is a schematic structural view of a first rotating body of a medical device delivery device according to an embodiment of the present invention.
- Figure 4 is a schematic cross-sectional view of a rotating body shown in Figure 3;
- FIG. 5 is a schematic structural view of a guide member of a medical device delivery device according to an embodiment of the present invention.
- 6a is a schematic cross-sectional view showing a first actuation unit of a medical device delivery device according to an embodiment of the present invention
- Figure 6b is a partial enlarged view of Figure 6a
- FIG. 7 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 8 is a schematic cross-sectional view of the structure shown in Figure 7;
- 9a to 9c are schematic views showing a process of loading a prosthetic heart valve using a medical device delivery device according to an embodiment of the present invention
- FIG. 10 is a schematic view showing the distal end structure of a recovery catheter of a medical device delivery device according to an embodiment of the present invention.
- 11a to 11h 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 recovery conduit 22, and a connecting conduit 23 that are coaxially disposed.
- Each of the outer sheath catheter 21, the recovery catheter 22, and the connecting catheter 23 is of a hollow structure and has openings at both ends.
- the recovery conduit 22 extends through the outer sheath conduit 21, and the connecting conduit 23 extends through the recovery conduit 22, and the lumen of the connecting conduit 23 is adapted to pass through the guide wire.
- the distal end of the recovery catheter 22 is further provided with a flared structure for facilitating pre-compression of the artificial heart valve.
- 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 recovery conduit 22 to actuate the recovery conduit 22 for axial movement.
- the third actuating unit 13 is coupled to the proximal end of the connecting conduit 23 to actuate the connecting conduit 23 to produce a circumferential rotation.
- the distal end of the connecting catheter 23 is also provided with a threaded structure (not shown) through which the connecting catheter 23 is 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 recovery catheter 22 is used to provide axial support force to the proximal end of the prosthetic heart valve loaded onto the delivery device 01 and axial thrust when the heart valve is released, and pre-shrinkage of the valve during recovery of the prosthetic heart valve In order to reduce the force required for the valve to receive the outer sheath catheter 21, and also to avoid excessive compression of the valve by the outer sheath catheter 21, resulting in deformation of the bioprosthetic valve of the valve.
- the material of the recovery conduit 22 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 thereof 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 image device to indicate the transport position of the transport 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 30.
- the handle housing 30 is detachable into a proximal handle 30b and a distal handle 30a.
- the handle housing 30 is used to provide accommodation and fixation, and the actuation assembly 10 can be assembled and fixed.
- the first actuating unit 11, the second actuating unit 12 and the third actuating unit 13 are axially arranged in sequence from the distal end to the proximal end in the handle housing 30.
- the proximal end of the handle housing 30 is further provided with a luer connector valve 40, which can be flushed to the lumen of the connecting catheter 23 after being connected to the syringe.
- the first actuating unit 11 includes a first rotating member 111, a guide member 112, and a fixing member 113.
- the first rotating member 111 is a cylindrical 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 outer end of the proximal rotating portion 111a is disposed outside the handle housing 30 for operator operation
- the distal rotating portion 111b is disposed in the distal handle housing 30, that is, the operator can operate the proximal rotating portion 111a to rotate, thereby driving The distal rotation portion 111b rotates.
- a guide groove 111c is further provided on the inner wall of the first rotating member 111.
- the guide groove 111c is spirally disposed around the axial direction of the first rotary member 111, and the spiral angle may range from 15 to 45, 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 30 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 engaged 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 a first adjusting member 113b and a first sealing ring 50a provided at a distal end of the first adjusting member 113b.
- the proximal end of the first joint body 113a is further provided with a proximal opening for receiving the first adjusting member 113b and the first sealing ring 50a, and the proximal opening of the first joint main body 113a communicates with the distal opening, and the push rod guide 22 passes the first A proximal end opening and a distal end opening of a joint main body 113a penetrate the first joint main body 113a.
- the first 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 first adjusting member 113b.
- the first sealing member 105b can be pressed to deform the first sealing ring 50a by adjusting the first regulating member 113b, thereby achieving the purpose of sealing the gap between the outer sheath catheter 21 and the push rod catheter 22.
- 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 121 and a connecting member 122.
- the second rotating member 122 has an axial through hole, and an internal thread is provided in the through hole.
- the main body of the connecting member 122 is a screw and is provided with an external thread that cooperates with the internal thread in the through hole of the second rotating member 122.
- the connecting member 122 has an axial through hole and integrally penetrates the through hole of the second rotating member 121.
- the connecting duct 23 penetrates the through hole of the second rotating member 121.
- the connecting member 122 is provided with a limiting member 123 at the proximal end and a receiving member 124 for receiving the recovery conduit 22 at the distal end.
- the receiving member 124 is coupled to the proximal end of the recovery conduit 22.
- the radial diameter of the limiting member 123 and the receiving member 124 is slightly larger than the inner diameter of the through hole of the second rotating member 122. This can limit the axial movement distance A of the connecting member 122, and ensure that the recovery catheter 22 does not excessively recover the artificial heart valve. Squeezing the valve also does not increase the difficulty of recovery due to insufficient pre-contraction of the valve.
- the connecting member 122 cannot continue to move to the distal end; when the receiving member 124 and the distal end surface of the second rotating member 121 abut, the connecting member 122 cannot Continue moving to the near end.
- the outer portion of the second rotating member 121 is exposed outside the handle housing 30, and the operator can operate to rotate the second rotating member 121 to drive the connecting member 122 to move axially while the recovery conduit 22 is axially moved. .
- the second actuating unit 12 can convert its own circumferential rotation into an axial movement of the recovery duct, which is appropriate with respect to the axially moving actuating unit.
- the overall size of the conveyor device 01 is reduced.
- the third actuating unit 13 includes a third rotating member 131 and a conduit joint 132.
- the third rotating body 131 has a through hole, and the conduit joint 132 is disposed in the opening at the proximal end of the through hole and does not easily fall off.
- the conduit connector 132 is coupled to the proximal end of the connecting conduit 23.
- the outer side of the third rotating body 131 is also partially exposed outside the handle housing 30, facilitating the operator to rotate the third rotating body 131, thereby driving the conduit joint 132 and the connecting conduit 23 connected to the conduit joint 132.
- the circumferential rotation causes the attachment and release of the delivery device 01 to the prosthetic heart valve.
- the proximal end opening of the through hole of the third rotating member 131 of the present embodiment is also connected to the tubular portion at the proximal end of the Luer fitting valve 40, so that the lumen of the connecting duct 23 can be flushed by the Luer fitting valve 40.
- a second sealing ring 50b and a second sealing and locking function are respectively provided between the limiting member 123 and the connecting member 122 and between the third rotating member 131 and the tubular portion at the proximal end of the Luer fitting valve 40.
- the seal ring 50c can seal the gap between the recovery duct 22 and the connecting duct 23 and the tubular portion that locks the proximal end of the Luer joint valve 40, respectively.
- the prosthetic heart valve generally includes a biological leaflet (not shown), a bare stent 62, and a portion of the membrane 61.
- the end of the bare bracket 62 is provided with a threaded structure connectable to the conveying device 01.
- the first rotating member 111 is first rotated to move the outer sheath catheter 21 toward the proximal end relative to the recovery conduit 22 and the connecting conduit 23, thereby causing the recovery conduit 22 and the connecting conduit 23
- the distal end surface is exposed from the lumen of the sheath catheter 21.
- the valve is then coupled to the connecting catheter 23 by a connecting catheter 23 and a threaded structure on the prosthetic heart valve.
- the second rotating member 121 is then rotated to move the recovery catheter 22 toward the distal end relative to the outer sheath catheter 21 and the connecting catheter 23, and the artificial heart valve bare stent 61 is partially collected into the recovery conduit 22 through the distal opening of the recovery catheter 22.
- the horn structure presses the bare stent 61 of the prosthetic heart valve to achieve pre-compression of the prosthetic heart valve as a whole, ensuring that the outer diameter of the junction of the bare stent 61 and the membrane 62 is smaller than the inner diameter of the sheath catheter 21, which is convenient for artificial The heart valve is sheathed.
- the first rotating body 111 is rotated again, the outer sheath catheter 21 is moved distally relative to the recovery catheter 22 and the connecting catheter 23, and the other parts of the artificial heart valve are completely collected into the inner cavity of the outer sheath catheter 21 to complete the artificial heart. Loading of the valve.
- the artificial heart valve is pre-compressed by the recovery catheter 22, so that the connection portion between the bare stent 61 and the membrane 62 is more easily sheathed, thereby avoiding the occurrence of artificial heart valve accumulation deformation, flanging or excessive loading force.
- the retrieval catheter 22 also provides some support to the prosthetic heart valve to prevent accumulation or axial displacement of the valve upon release.
- the first rotating member 111 is first rotated to move the outer sheath catheter 21 toward the proximal end relative to the recovery catheter 22 and the connecting catheter 23, releasing the radial restraint of the prosthetic heart valve. Then, the third rotating body 131 is rotated, the connecting catheter 23 is rotated circumferentially, and the screw connection between the connecting catheter 23 and the artificial heart valve is released, and the release of the artificial heart valve is completed.
- the third rotating body 131 can be rotated once again to connect the artificial heart valve with the connecting catheter 23, repeat the operation of the valve loading, adjust the release position of the artificial heart valve, and then release.
- FIG. 11a to FIG. 11h 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 11a.
- a soft guide wire 320 is inserted forward into the left ventricle of the heart, as shown in Fig. 11b.
- 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
- the 340 is located within the short sheath tube 330, as shown in FIG. 11c, and the distal end of the short sheath tube 330 or the dilator tube 340 or both may be provided with a developing ring 350.
- the balloon 341 is expanded and filled (as shown in Fig. 11d), and the expanded shape 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 11e.
- 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.
- the position of the artificial heart valve after release on the atrial side can also be observed by DSA angiography or ultrasound.
- the first rotating member 111 of the delivery device 01 can be adjusted to make the outer sheath catheter 21 axially
- the distal motion moves the prosthetic heart valve back into the outer sheath catheter 21, as shown in Figure 11g.
- the first rotating member 111 is rotated to move the outer sheath catheter 21 to the proximal end, the radial binding force to the distal end portion of the artificial heart valve is released, and then the second rotating member 121 is controlled to be recycled.
- the catheter 22 is moved proximally such that the proximal end of the prosthetic heart valve extends entirely out of the sheath catheter 21, as shown in Figure 11h.
- the third rotating member 131 is rotated, so that the connecting catheter 23 also rotates in the circumferential direction, and the threaded connection with the artificial heart valve is released, and the final release of the artificial heart valve is completed.
- the distal end of the retrieval catheter may also omit the flared configuration as long as the retrieval catheter can pre-compress the prosthetic heart valve.
- the distal end portion of the recovery catheter 22a may also be of the configuration shown in FIG. 10, that is, the distal end portion 221a of the recovery catheter 22a is a deformable wave structure, such as a bare metal stent. structure.
- the distal end portion 221a may be formed by heat-setting the distal end of the metal-made recovery catheter 22a after laser cutting. In the natural state, the distal end portion 221a is expanded relative to the recovery catheter 22a, that is, the outer diameter of the distal end portion 221a is larger than the recovery catheter 22a and larger than the inner diameter of the outer sheath catheter, facilitating the storage of a larger portion of the artificial heart valve.
- the distal end portion 221a can be compressively deformed when subjected to radial pressure of the sheath catheter. Further, in order to facilitate the recovery and friction reduction of the artificial heart valve, the distal portion 221a may also be provided with a self-slippery and high-strength film.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (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
A medical instrument delivery apparatus (01), comprising a hollow catheter assembly (20) and an actuating assembly (10) connected to the catheter assembly (20); the catheter assembly (20) comprises an outer sheath catheter (21), a recovery catheter (20) penetrating through the outer sheath catheter (21), and a connecting catheter (23) penetrating through the recovery catheter; the actuating assembly (10) comprises a first actuating unit (11), a second actuating unit (12), and a third actuating unit (13) axially arranged from the distal end to the proximal end, the first actuating unit (11) being connected to the outer sheath catheter and actuating the outer sheath catheter (21), the second actuating unit (12) being connected to the recovery catheter (22) and actuating the recovery catheter (22), and the third actuating unit (13) being connected to the connecting catheter (23) and actuating the connecting catheter (23). The present medical instrument delivery apparatus (01) can implement easy loading and release of a medical instrument, and recovery, adjustment, and re-release when the release position is unsatisfactory.
Description
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。The present invention relates to the field of interventional medical devices, and in particular to a medical device delivery device.
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***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。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. In addition, when the left ventricle contracts, 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. Various heart diseases or degenerative lesions may cause 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.
针对二尖瓣功能的障碍,存在多种治疗方法,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。There are a variety of treatments for mitral valve dysfunction, such as conventional valve replacement surgery, which is considered an "open heart" procedure. In short, the surgery needs to open the chest, start the extracorporeal circulation with the cardiopulmonary machine, open the heart, remove and replace the patient's mitral valve, but due to the complicated operation in vitro and the poor tolerance of elderly patients, "open heart" surgery There is a high risk of death. At present, the treatment of mitral dysfunction by intervention means has been gradually paid attention, and a transcutaneous catheter technique for delivering a replacement mitral valve with less trauma has been developed. In such techniques, the self-puncture prosthetic valve is typically mounted in a 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.
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,但由于二尖瓣复合体的解剖结构复杂和心室收缩产生的腔内压力大,人工瓣膜的释放位置可能不理想或在血流冲击下释放发生移位,需要对其进行回收并重新释放。目前的瓣膜输送装置都难以对人工心脏瓣膜进行回收,需要增加额外的装置配合使用,导致手术操作复杂,手术时间增加,增大手术风险。此外现有输送***和瓣膜置换方法操作过程复杂,且容易损伤心脏组织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输送装置和方法,输送装置能实现人工心脏瓣膜的轻松装载释放以及释放位置不佳时的回收调整与再释放。Although transcatheter interventional technique replacement of the natural mitral valve is an effective method for the treatment of dysfunction, due to the complex anatomy of the mitral valve complex and the increased intraluminal pressure caused by ventricular contraction, the release position of the prosthetic valve may be unsatisfactory or in blood. The release under the impact of the flow is displaced and needs to be recovered and re-released. At present, the valve delivery device is difficult to recover the artificial heart valve, and additional devices need to be used together, resulting in complicated operation, increased operation time, and increased surgical risk. In addition, the existing delivery system and the valve replacement method are complicated in operation, and are easy to damage the heart tissue, resulting in poor therapeutic effect. Accordingly, it is desirable to provide improved delivery devices and methods for treating valvular insufficiency, such as for the treatment of mitral regurgitation, which enable easy loading release of the prosthetic heart valve and recovery adjustment and re-release when the release position is poor.
发明内容Summary of the invention
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、贯穿所述外鞘导管的回收导管以及贯穿所述回收导管的连接导管;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、第二致动单元和第三致动单元,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回收导管相连且致动所述回收导管,所述第三致动单元与所述连接导管相连且致动所述连接导管。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, a recovery conduit extending through the outer sheath catheter, and through Retracting a connecting conduit of the catheter; the actuation assembly including a first actuation unit, a second actuation unit, and a third actuation unit disposed axially from the distal end to the proximal end, the first actuation unit and the first actuation unit An outer sheath conduit is coupled to actuate the outer sheath conduit, the second actuation unit is coupled to the recovery conduit and actuates the recovery conduit, the third actuation unit is coupled to the connection conduit and actuated The connecting conduit.
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。In an embodiment, 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.
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***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。In an embodiment, the inner wall of the first rotating member is provided with a spiral guiding groove that rotates axially around the first rotating member, and 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.
在一实施例中,所述导向槽的螺旋角度范围为15度至45度。In an embodiment, the guiding groove has a helix angle ranging from 15 degrees to 45 degrees.
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体与所述固定件之间,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。In an embodiment, the first actuating unit further includes a guiding member disposed between the first rotating body and the fixing member, the guiding member having a 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.
在一实施例中,所述第二致动单元包括第二旋转件和连接件,所述第二旋转件具有通孔,所述连接件穿设于所述通孔内,所述连接件与所述回收导管近端相连,所述第二旋转件周向转动时带动所述回收导管轴向移动。In an embodiment, the second actuating unit includes a second rotating member and a connecting member, the second rotating member has a through hole, the connecting member is disposed in the through hole, and the connecting member is The recovery duct is connected at a proximal end, and the second rotating member rotates in the circumferential direction to drive the recovery duct to move axially.
在一实施例中,所述第二致动单元还包括限位件,所述限位件设于所述连接件近端,用于限制所述回收导管向远端移动的距离。In an embodiment, the second actuating unit further includes a limiting member disposed at a proximal end of the connecting member for limiting a distance at which the recovery conduit moves distally.
在一实施例中,所述第三致动单元包括第三旋转件,所述第三旋转件与所述连接导管连接,所述第三旋转件周向转动时带动所述连接导管周向转动。In an embodiment, the third actuating unit includes a third rotating member, the third rotating member is coupled to the connecting conduit, and the third rotating member rotates circumferentially to rotate the connecting conduit. .
在一实施例中,所述输送装置还包括手柄壳体,从远端至近端, 所述第一致动单元、第二致动单元和第三致动单元依次设在所述手柄壳体内。In an embodiment, the conveying device further includes a handle housing, from the distal end to the proximal end, the first actuation unit, the second actuation unit and the third actuation unit are sequentially disposed in the handle housing .
在一实施例中,所述连接导管远端设有螺纹结构。In an embodiment, the distal end of the connecting catheter is provided with a threaded structure.
在一实施例中,所述回收导管远端设有喇叭形结构或可变形的波形结构。In an embodiment, the distal end of the recovery catheter is provided with a horn structure or a deformable wave structure.
本发明提供的医疗器械输送装置能实现医疗器械的轻松装载和释放以及释放位置不佳时的回收调整与再释放。The medical device delivery device provided by the invention can realize easy loading and release of the medical device and recovery adjustment and re-release when the release position is not good.
图1为本发明一实施例的医疗器械输送装置结构示意图;1 is a schematic structural view of a medical device delivery device according to an embodiment of the present invention;
图2为图1所示医疗器械输送装置的截面结构示意图;Figure 2 is a cross-sectional structural view of the medical device delivery device shown in Figure 1;
图3为本发明一实施例的医疗器械输送装置的第一旋转体结构示意图;3 is a schematic structural view of a first rotating body of a medical device delivery device according to an embodiment of the present invention;
图4为图3所示一旋转体的截面结构示意图;Figure 4 is a schematic cross-sectional view of a rotating body shown in Figure 3;
图5为本发明一实施例的医疗器械输送装置的导向件结构示意图;5 is a schematic structural view of a guide member of a medical device delivery device according to an embodiment of the present invention;
图6a为本发明一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;6a is a schematic cross-sectional view showing a first actuation unit of a medical device delivery device according to an embodiment of the present invention;
图6b为图6a的局部放大图;Figure 6b is a partial enlarged view of Figure 6a;
图7为本发明一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;7 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;
图8为图7所示结构的截面结构示意图;Figure 8 is a schematic cross-sectional view of the structure shown in Figure 7;
图9a至图9c为利用本发明一实施例的医疗器械输送装置装载人工心脏瓣膜时的过程示意图;9a to 9c are schematic views showing a process of loading a prosthetic heart valve using a medical device delivery device according to an embodiment of the present invention;
图10为本发明一实施例的医疗器械输送装置回收导管的远端结构示意图。10 is a schematic view showing the distal end structure of a recovery catheter of a medical device delivery device according to an embodiment of the present invention.
图11a至图11h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。11a to 11h are schematic views showing an operation procedure of artificial heart valve implantation using the delivery device of the present invention.
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。In order to better understand the technical solutions and the beneficial effects of the present invention, the present invention will be further described in detail below in conjunction with the specific embodiments. In the field of interventional medicine, the end that is defined near the operator is "proximal", the end far from the instrument operator is "distal"; the direction of the connection between the proximal center of the instrument and the distal center is "axial" The direction of the "axial direction" is "radial" and the direction of the "axial direction" is "circumferential". "Connecting" may be the direct connection of two objects, or the connection by other objects.
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。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. Hereinafter, the delivery device of the present invention will be described in detail by taking a prosthetic heart valve as an example.
参见图1和图2,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。Referring to Figures 1 and 2, 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.
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、回收导管22和连接导管23。外鞘导管21、回收导管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, 回收导管22贯穿外鞘导管21,连接导管23贯穿回收导管22,连接导管23的内腔可供导丝穿过。回收导管22与连接导管23以及回收导管22与外鞘导管21之间均存在间隙,方便导管之间相对运动。优选地,本实施例中,回收导管22的远端还设置成喇叭形结构,方便对人工心脏瓣膜进行预压缩。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与回收导管22近端连接,以致动回收导管22产生轴向运动。第三致动单元13与连接导管23近端连接,以致动连接导管23产生周向转动。同时,连接导管23远端还设有螺纹结构(图未标),连接导管23通过该螺纹结构实现与人工心脏瓣膜的连接或解脱。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 recovery conduit 22, and a connecting conduit 23 that are coaxially disposed. Each of the outer sheath catheter 21, the recovery catheter 22, and the connecting catheter 23 is of a hollow structure and has openings at both ends. Wherein, the recovery conduit 22 extends through the outer sheath conduit 21, and the connecting conduit 23 extends through the recovery conduit 22, and the lumen of the connecting conduit 23 is adapted to pass through the guide wire. There is a gap between the recovery conduit 22 and the connecting conduit 23 and between the recovery conduit 22 and the outer sheath conduit 21 to facilitate relative movement between the conduits. Preferably, in the present embodiment, the distal end of the recovery catheter 22 is further provided with a flared structure for facilitating pre-compression of the artificial heart valve. 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 recovery conduit 22 to actuate the recovery conduit 22 for axial movement. The third actuating unit 13 is coupled to the proximal end of the connecting conduit 23 to actuate the connecting conduit 23 to produce a circumferential rotation. At the same time, the distal end of the connecting catheter 23 is also provided with a threaded structure (not shown) through which the connecting catheter 23 is connected or released from the artificial heart valve.
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。回收导管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,还可以在回收人工心脏瓣膜时对瓣膜进行预收缩挤压,以降低瓣膜收入外鞘导管21所需要的力,同时也避免外鞘导管21对瓣膜的过分挤压,导致瓣膜的生物瓣变形损伤。回收导管22的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,其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。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 recovery catheter 22 is used to provide axial support force to the proximal end of the prosthetic heart valve loaded onto the delivery device 01 and axial thrust when the heart valve is released, and pre-shrinkage of the valve during recovery of the prosthetic heart valve In order to reduce the force required for the valve to receive the outer sheath catheter 21, and also to avoid excessive compression of the valve by the outer sheath catheter 21, resulting in deformation of the bioprosthetic valve of the valve. The material of the recovery conduit 22 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 thereof may be a polymer material or a metal, such as PEEK, stainless steel, nickel titanium or titanium.
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。The distal end of the outer sheath catheter 21 is also provided with a developing ring 211 which can be imaged under the image device to indicate the transport position of the transport 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.
输送装置01还包括手柄壳体30。手柄壳体30可拆解成近端手柄30b和远端手柄30a。手柄壳体30用于提供收容和固定作用,能将致动组件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30内由远端至近端依次轴向排列设置。手柄壳体30近端端部还设有鲁尔接头阀40,鲁尔接头阀40与注射器连接后可对连接导管23的内腔进行冲洗。The delivery device 01 also includes a handle housing 30. The handle housing 30 is detachable into a proximal handle 30b and a distal handle 30a. The handle housing 30 is used to provide accommodation and fixation, and the actuation assembly 10 can be assembled and fixed. The first actuating unit 11, the second actuating unit 12 and the third actuating unit 13 are axially arranged in sequence from the distal end to the proximal end in the handle housing 30. The proximal end of the handle housing 30 is further provided with a luer connector valve 40, which can be flushed to the lumen of the connecting catheter 23 after being connected to the syringe.
同时参见图3至图6b,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圆筒状结构,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外侧设于手柄壳体30外以便于操作者操作,远端旋转部111b设于远端手柄壳体30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环绕第一旋转件111的轴向螺旋设置,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30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。3 to 6b, the first actuating unit 11 includes a first rotating member 111, a guide member 112, and a fixing member 113. Wherein, the first rotating member 111 is a cylindrical 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. Wherein, the outer end of the proximal rotating portion 111a is disposed outside the handle housing 30 for operator operation, and the distal rotating portion 111b is disposed in the distal handle housing 30, that is, the operator can operate the proximal rotating portion 111a to rotate, thereby driving The distal rotation portion 111b rotates. A guide groove 111c is further provided on the inner wall of the first rotating member 111. The guide groove 111c is spirally disposed around the axial direction of the first rotary member 111, and the spiral angle may range from 15 to 45, 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 30 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 engaged 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. In the present embodiment, the distal end of the first joint body 113a is screwed to the proximal end of the sheath catheter 21. It can be understood that in other embodiments, 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.
进一步地,固定件113还包括第一调节件113b和设于第一调节件113b远端的第一密封圈50a。第一接头主体113a近端还设有收容第一调节件113b和第一密封圈50a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。第一调节件113b上设有外螺纹,第一接头主体113a的近端开口内设有与第一调节件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,通过调节第一调节件113b可挤压第一密封圈50a变形,实现密封外鞘导管21和推杆导管22之间间隙的目的。Further, the fixing member 113 further includes a first adjusting member 113b and a first sealing ring 50a provided at a distal end of the first adjusting member 113b. The proximal end of the first joint body 113a is further provided with a proximal opening for receiving the first adjusting member 113b and the first sealing ring 50a, and the proximal opening of the first joint main body 113a communicates with the distal opening, and the push rod guide 22 passes the first A proximal end opening and a distal end opening of a joint main body 113a penetrate the first joint main body 113a. The first 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 first adjusting member 113b. When the catheter assembly 20 of the delivery device 01 and the actuator assembly 10 are assembled, the first sealing member 105b can be pressed to deform the first sealing ring 50a by adjusting the first regulating member 113b, thereby achieving the purpose of sealing the gap between the outer sheath catheter 21 and the push rod catheter 22.
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。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. Wherein, 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.
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。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. .
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。In other embodiments, 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.
同时参阅图7和图8,第二致动单元12包括第二旋转件121和连接件122。第二旋转件122具有轴向通孔,通孔内设有内螺纹。连接件122主体为螺杆且设有与第二旋转件122通孔内内螺纹相配合的外螺纹。连接件122具有轴向通孔且整体贯穿第二旋转件121的通孔。连接导管23贯穿第二旋转件121的通孔。连接件122近端设有限位件123,远端设有能收容回收导管22的收容件124。收容件124与回收导管22近端连接。限位件123与收容件124径向直径略大于第二 旋转件122的通孔内径,这样可以限制连接件122的轴向移动距离A,保证回收导管22对人工心脏瓣膜进行回收时不会过度挤压瓣膜也不会因为预收缩瓣膜程度不够导致回收难度增加。具体地,当限位件123与第二旋转件122近端端面相抵时,连接件122无法继续向远端移动;当收容件124与第二旋转件121远端端面相抵时,连接件122无法继续向近端移动。再次参阅图1,第二旋转件121的外侧部分外露于手柄壳体30外,操作者可以操作转动第二旋转件121,从而带动连接件122轴向移动,同时使回收导管22做轴向运动。因手柄壳体30对第二旋转件121的固定作用,第二致动单元12可以将自身的周向转动转化成回收导管的轴向移动,相对于轴向移动的致动单元而言,适当降低了输送装置01的整体尺寸。7 and 8, the second actuating unit 12 includes a second rotating member 121 and a connecting member 122. The second rotating member 122 has an axial through hole, and an internal thread is provided in the through hole. The main body of the connecting member 122 is a screw and is provided with an external thread that cooperates with the internal thread in the through hole of the second rotating member 122. The connecting member 122 has an axial through hole and integrally penetrates the through hole of the second rotating member 121. The connecting duct 23 penetrates the through hole of the second rotating member 121. The connecting member 122 is provided with a limiting member 123 at the proximal end and a receiving member 124 for receiving the recovery conduit 22 at the distal end. The receiving member 124 is coupled to the proximal end of the recovery conduit 22. The radial diameter of the limiting member 123 and the receiving member 124 is slightly larger than the inner diameter of the through hole of the second rotating member 122. This can limit the axial movement distance A of the connecting member 122, and ensure that the recovery catheter 22 does not excessively recover the artificial heart valve. Squeezing the valve also does not increase the difficulty of recovery due to insufficient pre-contraction of the valve. Specifically, when the limiting member 123 abuts the proximal end surface of the second rotating member 122, the connecting member 122 cannot continue to move to the distal end; when the receiving member 124 and the distal end surface of the second rotating member 121 abut, the connecting member 122 cannot Continue moving to the near end. Referring again to FIG. 1, the outer portion of the second rotating member 121 is exposed outside the handle housing 30, and the operator can operate to rotate the second rotating member 121 to drive the connecting member 122 to move axially while the recovery conduit 22 is axially moved. . Due to the fixing action of the handle housing 30 on the second rotating member 121, the second actuating unit 12 can convert its own circumferential rotation into an axial movement of the recovery duct, which is appropriate with respect to the axially moving actuating unit. The overall size of the conveyor device 01 is reduced.
第三致动单元13包括第三旋转件131和导管接头132。第三旋转体131具有通孔,导管接头132设于该通孔近端的开口内且不会轻易脱落。导管接头132与连接导管23近端连接。与第二旋转体121一样,第三旋转体131的外侧亦部分外露于手柄壳体30外,方便操作者转动第三旋转体131,从而带动导管接头132以及与导管接头132连接的连接导管23周向转动,实现输送装置01对人工心脏瓣膜的连接装载和解脱释放。本实施例的第三旋转件131的通孔近端开口还与鲁尔接头阀40近端的管状部相连,这样可以通过鲁尔接头阀40对连接导管23内腔进行冲洗。进一步地,限位件123与连接件122之间以及第三旋转件131与鲁尔接头阀40近端的管状部之间均分别设有起密封和锁定作用的第二密封圈50b和第二密封圈50c,能分别密封 回收导管22与连接导管23之间的间隙以及锁紧鲁尔接头阀40近端的管状部。The third actuating unit 13 includes a third rotating member 131 and a conduit joint 132. The third rotating body 131 has a through hole, and the conduit joint 132 is disposed in the opening at the proximal end of the through hole and does not easily fall off. The conduit connector 132 is coupled to the proximal end of the connecting conduit 23. Like the second rotating body 121, the outer side of the third rotating body 131 is also partially exposed outside the handle housing 30, facilitating the operator to rotate the third rotating body 131, thereby driving the conduit joint 132 and the connecting conduit 23 connected to the conduit joint 132. The circumferential rotation causes the attachment and release of the delivery device 01 to the prosthetic heart valve. The proximal end opening of the through hole of the third rotating member 131 of the present embodiment is also connected to the tubular portion at the proximal end of the Luer fitting valve 40, so that the lumen of the connecting duct 23 can be flushed by the Luer fitting valve 40. Further, between the limiting member 123 and the connecting member 122 and between the third rotating member 131 and the tubular portion at the proximal end of the Luer fitting valve 40, a second sealing ring 50b and a second sealing and locking function are respectively provided. The seal ring 50c can seal the gap between the recovery duct 22 and the connecting duct 23 and the tubular portion that locks the proximal end of the Luer joint valve 40, respectively.
参见图9a至9c,人工心脏瓣膜一般包括生物瓣叶(未示出)、裸支架62和覆膜61部分。其中裸支架62末端设有可与输送装置01连接的螺纹结构。在利用本发明的医疗器械输送装置01进行瓣膜装载时,首先转动第一旋转件111,使外鞘导管21相对回收导管22和连接导管23朝向近端移动,进而使得回收导管22和连接导管23的远端端面从外鞘导管21的内腔内露出。然后通过连接导管23和人工心脏瓣膜上的螺纹结构将瓣膜连接至连接导管23上。接着转动第二旋转件121,使回收导管22相对外鞘导管21和连接导管23朝向远端移动,将人工心脏瓣膜裸支架61部分收入至回收导管22中,通过回收导管22远端开口处的喇叭形结构对人工心脏瓣膜的裸支架61进行挤压,从而实现对人工心脏瓣膜整体的预压缩,保证裸支架61与覆膜62的连接处的外径小于外鞘导管21的内径,方便人工心脏瓣膜进鞘。最后再次转动第一旋转体111,使外鞘导管21相对回收导管22和连接导管23向远端移动,将人工心脏瓣膜的其它部分完全收至外鞘导管21的内腔内,完成对人工心脏瓣膜的装载。Referring to Figures 9a through 9c, the prosthetic heart valve generally includes a biological leaflet (not shown), a bare stent 62, and a portion of the membrane 61. The end of the bare bracket 62 is provided with a threaded structure connectable to the conveying device 01. When the valve loading is performed by the medical device delivery device 01 of the present invention, the first rotating member 111 is first rotated to move the outer sheath catheter 21 toward the proximal end relative to the recovery conduit 22 and the connecting conduit 23, thereby causing the recovery conduit 22 and the connecting conduit 23 The distal end surface is exposed from the lumen of the sheath catheter 21. The valve is then coupled to the connecting catheter 23 by a connecting catheter 23 and a threaded structure on the prosthetic heart valve. The second rotating member 121 is then rotated to move the recovery catheter 22 toward the distal end relative to the outer sheath catheter 21 and the connecting catheter 23, and the artificial heart valve bare stent 61 is partially collected into the recovery conduit 22 through the distal opening of the recovery catheter 22. The horn structure presses the bare stent 61 of the prosthetic heart valve to achieve pre-compression of the prosthetic heart valve as a whole, ensuring that the outer diameter of the junction of the bare stent 61 and the membrane 62 is smaller than the inner diameter of the sheath catheter 21, which is convenient for artificial The heart valve is sheathed. Finally, the first rotating body 111 is rotated again, the outer sheath catheter 21 is moved distally relative to the recovery catheter 22 and the connecting catheter 23, and the other parts of the artificial heart valve are completely collected into the inner cavity of the outer sheath catheter 21 to complete the artificial heart. Loading of the valve.
通过回收导管22对人工心脏瓣膜进行初步预压缩,使裸支架61与覆膜62的连接部分更容易进鞘,避免发生人工心脏瓣膜堆积变形、翻边或装载力过大的情况。同时,回收导管22还对人工心脏瓣膜提供了一定的支撑力,避免瓣膜在释放的时候发生堆积或轴向移位。The artificial heart valve is pre-compressed by the recovery catheter 22, so that the connection portion between the bare stent 61 and the membrane 62 is more easily sheathed, thereby avoiding the occurrence of artificial heart valve accumulation deformation, flanging or excessive loading force. At the same time, the retrieval catheter 22 also provides some support to the prosthetic heart valve to prevent accumulation or axial displacement of the valve upon release.
释放人工心脏瓣膜时,首先转动第一旋转件111,使外鞘导管21 相对回收导管22和连接导管23朝向近端移动,解除对人工心脏瓣膜的径向束缚。接着转动第三旋转体131,使连接导管23周向转动,解脱连接导管23与人工心脏瓣膜的螺纹连接,完成人工心脏瓣膜的释放。当人工心脏瓣膜的释放位置不佳时,可以再一次转动第三旋转体131使人工心脏瓣膜与连接导管23连接,重复瓣膜装载的操作过程,调整人工心脏瓣膜的释放位置,再释放即可。When the prosthetic heart valve is released, the first rotating member 111 is first rotated to move the outer sheath catheter 21 toward the proximal end relative to the recovery catheter 22 and the connecting catheter 23, releasing the radial restraint of the prosthetic heart valve. Then, the third rotating body 131 is rotated, the connecting catheter 23 is rotated circumferentially, and the screw connection between the connecting catheter 23 and the artificial heart valve is released, and the release of the artificial heart valve is completed. When the release position of the artificial heart valve is not good, the third rotating body 131 can be rotated once again to connect the artificial heart valve with the connecting catheter 23, repeat the operation of the valve loading, adjust the release position of the artificial heart valve, and then release.
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11a至图11h,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11a所示。接着,使用穿刺针对心尖进行穿刺,向前***一根软导丝320进入心脏左心室,如图11b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11c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11d),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***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11e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11f所示。此时,还可通过DSA造影或超声观察人工心脏瓣膜在心房侧释放后的位置,若发现释放位置不理想,可通过调节输送装置01第一旋转件111,使外鞘导管21沿轴向向远端运动,将人工心脏瓣膜重新收回到外鞘导管21中,如图11g所示。调整好位置后再次释放人工心脏瓣膜,转动第一旋转件111使外鞘导管21向近端运动,解除对人工心脏瓣膜远端部分的径向约束力,接着控制第二旋转件121,使回收导管22向近端运动,使得人工心脏瓣膜近端全部伸出外鞘导管21,如图11h所示。最后旋转第三旋转件131,使得连接导管23也随着周向转动,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。Specifically, the method of using the delivery device 01 of the present invention will be described by exemplifying the implantation of a prosthetic heart valve into a human heart. Please also refer to FIG. 11a to FIG. 11h, 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. Before using the delivery device 01 of the present invention, 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 11a. Next, puncture is performed on the apex using a puncture, and a soft guide wire 320 is inserted forward into the left ventricle of the heart, as shown in Fig. 11b. 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 The 340 is located within the short sheath tube 330, as shown in FIG. 11c, and the distal end of the short sheath tube 330 or the dilator tube 340 or both may be provided with a developing ring 350. Then, the balloon 341 is expanded and filled (as shown in Fig. 11d), and the expanded shape 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. Next, with the aid of DSA and ultrasound, 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 11e. Next, 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. After the position confirmation is correct, 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 11f. At this time, the position of the artificial heart valve after release on the atrial side can also be observed by DSA angiography or ultrasound. If the release position is found to be unsatisfactory, the first rotating member 111 of the delivery device 01 can be adjusted to make the outer sheath catheter 21 axially The distal motion moves the prosthetic heart valve back into the outer sheath catheter 21, as shown in Figure 11g. After the position is adjusted, the artificial heart valve is released again, the first rotating member 111 is rotated to move the outer sheath catheter 21 to the proximal end, the radial binding force to the distal end portion of the artificial heart valve is released, and then the second rotating member 121 is controlled to be recycled. The catheter 22 is moved proximally such that the proximal end of the prosthetic heart valve extends entirely out of the sheath catheter 21, as shown in Figure 11h. Finally, the third rotating member 131 is rotated, so that the connecting catheter 23 also rotates in the circumferential direction, and the threaded connection with the artificial heart valve is released, and the final release of the artificial heart valve is completed.
可以理解的是,在其它实施例中,回收导管的远端也可以省略喇叭形结构,只要回收导管能对人工心脏瓣膜进行预压缩即可。It will be appreciated that in other embodiments, the distal end of the retrieval catheter may also omit the flared configuration as long as the retrieval catheter can pre-compress the prosthetic heart valve.
同样可以理解的是,在其它实施例中,回收导管22a的远端部还可以是如图10所示的结构,即回收导管22a的远端部221a为可变形的波形结构,例如金属裸支架结构。远端部221a可以是金属材质的 回收导管22a的远端经激光切割后热定型形成。自然状态下,远端部221a相对于回收导管22a外扩,即远端部221a的外径大于回收导管22a,且大于外鞘导管的内径,方便收纳更大部分的人工心脏瓣膜。当远端部221a受到外鞘导管的径向压力时可被压缩变形。进一步地,为方便对人工心脏瓣膜进行回收和减少摩擦,远端部221a上还可以设置自滑性好、强度高的覆膜。It is also understood that in other embodiments, the distal end portion of the recovery catheter 22a may also be of the configuration shown in FIG. 10, that is, the distal end portion 221a of the recovery catheter 22a is a deformable wave structure, such as a bare metal stent. structure. The distal end portion 221a may be formed by heat-setting the distal end of the metal-made recovery catheter 22a after laser cutting. In the natural state, the distal end portion 221a is expanded relative to the recovery catheter 22a, that is, the outer diameter of the distal end portion 221a is larger than the recovery catheter 22a and larger than the inner diameter of the outer sheath catheter, facilitating the storage of a larger portion of the artificial heart valve. The distal end portion 221a can be compressively deformed when subjected to radial pressure of the sheath catheter. Further, in order to facilitate the recovery and friction reduction of the artificial heart valve, the distal portion 221a may also be provided with a self-slippery and high-strength film.
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。The above embodiments are merely preferred embodiments of the present invention, and all of the alternatives are not listed, and thus the above embodiments are not to be construed as limiting the present invention. At the same time, those skilled in the art can make a simple change and replacement of the corresponding partial structure or connection mode according to actual needs, and the scope of protection of the present invention is subject to the claims.
Claims (11)
- 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、贯穿所述外鞘导管的回收导管以及贯穿所述回收导管的连接导管;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、第二致动单元和第三致动单元,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回收导管相连且致动所述回收导管,所述第三致动单元与所述连接导管相连且致动所述连接导管。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, a recovery conduit extending through the outer sheath catheter, and through Retracting a connecting conduit of the catheter; the actuation assembly including a first actuation unit, a second actuation unit, and a third actuation unit disposed axially from the distal end to the proximal end, the first actuation unit and the first actuation unit An outer sheath conduit is coupled to actuate the outer sheath conduit, the second actuation unit is coupled to the recovery conduit and actuates the recovery conduit, the third actuation unit is coupled to the connection conduit and actuated The connecting conduit.
- 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。The medical device delivery device according to claim 1, wherein the first actuation unit comprises a first rotating member and a fixing member, the first rotating member has an inner cavity, and the fixing member is received in the 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 rotating circumferentially drives the fixing member and the outer sheath guiding rod relative to the first rotating member shaft Move to.
- 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***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。The medical device delivery device according to claim 2, wherein the inner wall of the first rotating member is provided with a spiral guiding groove that rotates axially around the first rotating member, and the fixing member includes a first joint a main body and a rolling member disposed on a sidewall of the first joint body, 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 The first joint body is connected to the proximal end of the outer sheath catheter between the receiving groove and the receiving groove.
- 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。The medical device delivery device according to claim 3, wherein the guide groove has a helix angle ranging from 15 degrees to 45 degrees.
- 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体与所述固定件之间,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。The medical device delivery device according to claim 2, wherein the first actuation unit further comprises a guide member, the guide member being disposed between the first rotating body and the fixing member, The guide member has an inner cavity and a side wall, and 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.
- 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和连接件,所述第二旋转件具有通孔,所述连接件穿设于所述通孔内,所述连接件与所述回收导管近端相连,所述第二旋转件周向转动时带动所述回收导管轴向移动。The medical device delivery device according to claim 1, wherein said second actuation unit comprises a second rotating member and a connecting member, said second rotating member having a through hole, said connecting member being passed through In the through hole, the connecting member is connected to the proximal end of the recovery duct, and the second rotating member rotates in the circumferential direction to drive the recovery duct to move axially.
- 根据权利要求6所述的医疗器械输送装置,其特征在于,所述第二致动单元还包括限位件,所述限位件设于所述连接件近端,用于限制所述回收导管向远端移动的距离。The medical device delivery device according to claim 6, wherein the second actuating unit further comprises a limiting member, the limiting member being disposed at a proximal end of the connecting member for limiting the recycling conduit The distance to move to the far end.
- 根据权利要求1所述的医疗器械输送装置,其特征在于,所述第三致动单元包括第三旋转件,所述第三旋转件与所述连接导管连接,所述第三旋转件周向转动时带动所述连接导管周向转动。The medical device delivery device according to claim 1, wherein said third actuating unit comprises a third rotating member, said third rotating member being coupled to said connecting conduit, said third rotating member circumferentially The connecting catheter drives the circumferential rotation when rotating.
- 根据权利要求1至8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,从远端至近端,所述第一致动单元、第二致动单元和第三致动单元依次设在所述手柄壳体内。The medical device delivery device according to any one of claims 1 to 8, wherein the delivery device further comprises a handle housing, from the distal end to the proximal end, the first actuation unit, the second The moving unit and the third actuating unit are sequentially disposed in the handle housing.
- 根据权利要求1至8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。The medical device delivery device according to any one of claims 1 to 8, wherein the distal end of the connecting catheter is provided with a threaded structure.
- 根据权利要求1至8中任一项所述的医疗器械输送装置,其特征 在于,所述回收导管远端设有喇叭形结构或可变形的波形结构。The medical device delivery device according to any one of claims 1 to 8, wherein the distal end of the recovery catheter is provided with a horn structure or a deformable wave structure.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201711479941.8A CN109984866B (en) | 2017-12-29 | 2017-12-29 | Medical instrument conveying device |
CN201711479941.8 | 2017-12-29 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2019128702A1 true WO2019128702A1 (en) | 2019-07-04 |
Family
ID=67066438
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/CN2018/120322 WO2019128702A1 (en) | 2017-12-29 | 2018-12-11 | Medical instrument delivery apparatus |
Country Status (2)
Country | Link |
---|---|
CN (1) | CN109984866B (en) |
WO (1) | WO2019128702A1 (en) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112206073B (en) * | 2020-09-29 | 2024-01-30 | 北京华医圣杰科技有限公司 | Delivery system for ventricular volume reduction device |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20050096666A1 (en) * | 2002-12-05 | 2005-05-05 | Gordon Lucas S. | Percutaneous mitral valve annuloplasty delivery system |
CN102196784A (en) * | 2008-08-22 | 2011-09-21 | 爱德华兹生命科学公司 | Prosthetic heart valve and delivery apparatus |
CN102573703A (en) * | 2009-08-27 | 2012-07-11 | 麦德托尼克公司 | Transcatheter valve delivery systems and methods |
EP2862546A1 (en) * | 2013-10-21 | 2015-04-22 | St. Jude Medical, Cardiology Division, Inc. | Transcatheter valve implantation access sheaths |
WO2016168609A1 (en) * | 2015-04-16 | 2016-10-20 | Tendyne Holdings, Inc. | Apparatus and methods for delivery, repositioning, and retrieval of transcatheter prosthetic valves |
CN107496055A (en) * | 2017-08-10 | 2017-12-22 | 上海微创心通医疗科技有限公司 | Heart valve delivery catheter and induction system |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8518106B2 (en) * | 2010-02-17 | 2013-08-27 | Medtronic, Inc. | Catheter assembly with valve crimping accessories |
US8512401B2 (en) * | 2010-04-12 | 2013-08-20 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery system with funnel recapturing feature and method |
US8579963B2 (en) * | 2010-04-13 | 2013-11-12 | Medtronic, Inc. | Transcatheter prosthetic heart valve delivery device with stability tube and method |
EP2428189A1 (en) * | 2010-09-10 | 2012-03-14 | Symetis Sa | Catheter delivery system for stent valve |
JP6227632B2 (en) * | 2012-05-16 | 2017-11-08 | イェーナヴァルヴ テクノロジー ゲゼルシャフト ミット ベシュレンクテル ハフツング | Catheter delivery system for introducing expandable heart substitute valve and medical device for treatment of heart valve defects |
CN102764165B (en) * | 2012-08-13 | 2015-01-07 | 宁波健世生物科技有限公司 | Percutaneous aorta or aorta valve stent conveying system |
WO2017184887A1 (en) * | 2016-04-21 | 2017-10-26 | Zenflow, Inc. | Systems and methods for implants and deployment devices |
-
2017
- 2017-12-29 CN CN201711479941.8A patent/CN109984866B/en active Active
-
2018
- 2018-12-11 WO PCT/CN2018/120322 patent/WO2019128702A1/en active Application Filing
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20050096666A1 (en) * | 2002-12-05 | 2005-05-05 | Gordon Lucas S. | Percutaneous mitral valve annuloplasty delivery system |
CN102196784A (en) * | 2008-08-22 | 2011-09-21 | 爱德华兹生命科学公司 | Prosthetic heart valve and delivery apparatus |
CN102573703A (en) * | 2009-08-27 | 2012-07-11 | 麦德托尼克公司 | Transcatheter valve delivery systems and methods |
EP2862546A1 (en) * | 2013-10-21 | 2015-04-22 | St. Jude Medical, Cardiology Division, Inc. | Transcatheter valve implantation access sheaths |
WO2016168609A1 (en) * | 2015-04-16 | 2016-10-20 | Tendyne Holdings, Inc. | Apparatus and methods for delivery, repositioning, and retrieval of transcatheter prosthetic valves |
CN107496055A (en) * | 2017-08-10 | 2017-12-22 | 上海微创心通医疗科技有限公司 | Heart valve delivery catheter and induction system |
Also Published As
Publication number | Publication date |
---|---|
CN109984866B (en) | 2021-05-07 |
CN109984866A (en) | 2019-07-09 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US11826250B2 (en) | Transcatheter valve prosthesis delivery system with recapturing feature and method | |
CN111557765B (en) | Storage assembly for prosthetic valve | |
US20240115380A1 (en) | System and method for transaortic delivery of a prosthetic heart valve | |
JP6576944B2 (en) | Toggle cell fixation in mitral valve replacement | |
JP5095625B2 (en) | Transapical heart valve delivery system | |
US8740976B2 (en) | Transcatheter prosthetic heart valve delivery system with flush report | |
WO2019128653A1 (en) | Medical appliance deployment apparatus | |
CN110897763B (en) | Medical instrument conveying device | |
US20140052239A1 (en) | Conveying appliance with valve locating function for use during percutaneous aortic valve replacement operation | |
JP2013521884A (en) | Sinus engagement fixing member | |
JP2016506795A5 (en) | ||
CN110313947A (en) | Heart valve repair system | |
US11135053B2 (en) | Implantation method of artificial heart valve | |
CN111374798B (en) | Interventional guiding device | |
WO2019128702A1 (en) | Medical instrument delivery apparatus | |
CN109984869B (en) | Heart valve prosthesis delivery device | |
CN216221855U (en) | Conveying device for valve prosthesis and valve prosthesis system | |
US20220331106A1 (en) | Anchor designs with adaptable length control | |
JP2023530644A (en) | RELEASE MECHANISM FOR DELIVERY APPARATUS FOR IMPLANTABLE MEDICAL DEVICES | |
CN211934440U (en) | Conveyor and conveying system | |
US20240225838A1 (en) | Annulus repair methods and systems | |
CN219680862U (en) | Delivery assembly for a delivery system, and valve prosthesis system | |
US20220087818A1 (en) | Methods and systems for delivery device insertion during medical device crimp processes | |
CN117481871A (en) | Prosthetic valve conveying device and system | |
CN116785027A (en) | Interventional mitral valve replacement device suitable for mitral stenosis |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 18895120 Country of ref document: EP Kind code of ref document: A1 |
|
NENP | Non-entry into the national phase |
Ref country code: DE |
|
122 | Ep: pct application non-entry in european phase |
Ref document number: 18895120 Country of ref document: EP Kind code of ref document: A1 |