WO2019128702A1

WO2019128702A1 - Medical instrument delivery apparatus

Info

Publication number: WO2019128702A1
Application number: PCT/CN2018/120322
Authority: WO
Inventors: 谢惠雄; 江巍; 王刚; 严新火
Original assignee: 先健科技(深圳)有限公司
Priority date: 2017-12-29
Filing date: 2018-12-11
Publication date: 2019-07-04
Also published as: CN109984866B; CN109984866A

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

Medical device delivery device

Technical field

The present invention relates to the field of interventional medical devices, and in particular to a medical device delivery device.

Background technique

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.

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.

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.

Summary of the invention

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.

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.

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.

In an embodiment, the guiding groove has a helix angle ranging from 15 degrees to 45 degrees.

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.

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.

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.

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. .

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 .

In an embodiment, the distal end of the connecting catheter is provided with a threaded structure.

In an embodiment, 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.

DRAWINGS

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;

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;

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;

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;

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.

Detailed ways

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.

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.

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.

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.

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.

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.

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.

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.

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. .

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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 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.
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.
The medical device delivery device according to claim 3, wherein the guide groove has a helix angle ranging from 15 degrees to 45 degrees.
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.
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.
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.
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.
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.
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.
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.