Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
It should be understood that the directions or positional relationships indicated by "front", "rear", "upper", "lower", "left", "right", "longitudinal", "transverse", "vertical", "horizontal", "top", "bottom", "inner", "outer", "head", "tail", etc. are configured and operated in a specific direction based on the directions or positional relationships of the drawings, are merely for convenience of description of the present invention, and do not indicate that the apparatus or element referred to must have a specific direction, and thus should not be construed as limiting the present invention.
It should also be noted that unless explicitly stated or limited otherwise, terms such as "mounted," "connected," "secured," "disposed," and the like are to be construed broadly, and may be fixedly connected, detachably connected, or integrally formed, directly connected, indirectly connected via an intermediate medium, or in communication between two elements or in an interaction relationship between two elements. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element or one or more intervening elements may also be present. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
In the description of the present invention, it should be still noted that, the proximal end refers to the end of the instrument or component that is close to the operator, the distal end refers to the end of the instrument or component that is far away from the operator, the axial direction refers to the direction parallel to the line connecting the distal end and the center of the proximal end of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction around the axial direction.
In order to overcome the defect that the implant cannot be retracted by the conveying pipe structure of the interventional therapy in the prior art, the invention discloses a conveying pipe assembly and a transcatheter valve repair system, which can retract the implant into the conveying pipe assembly when needed, so that the position of the implant can be conveniently adjusted. The invention is illustrated below by means of specific examples and the accompanying drawings.
Example 1
Referring to fig. 1 and 2, a delivery catheter assembly 100 is disclosed in accordance with an embodiment of the present invention, including an introducer sheath 110 and a bend adjustment sheath 120. The bending adjusting sheath tube 120 is movably arranged in the guiding sheath tube 110. The bending sheath 120 is provided with a first auxiliary member 121 protruding near the distal end, the first auxiliary member 121 is disposed on the outer periphery of the bending sheath 120 and is symmetrical with respect to the central axis of the bending sheath 120, and the first auxiliary member 121 is at least partially stopped at the distal opening of the guiding sheath 110.
In the delivery catheter assembly 100 of the present invention, the inner cavity of the guiding sheath 110 is used to provide a delivery channel for the bending sheath 120 and the implant 200, and the bending sheath 120 is provided with a protruding first auxiliary member 121, and at least part of the structure of the first auxiliary member 121 has an outer diameter larger than the inner diameter of the guiding sheath 110, so that the first auxiliary member 121 at least partially stops at the distal opening of the guiding sheath 110. During the implantation of the implant 200, after the implant 200 is extended from the introducer sheath 110, if the implant 200 does not reach the precise surgical site, the implant 200 needs to be recovered to the introducer sheath 110 before the extension position of the implant 200 is readjusted. At this time, under the action of the withdrawing force, the outer diameter of the first auxiliary member 121 is larger, so that the guiding sheath tube 110 will be slightly deformed and enter the guiding sheath tube 110, and at this time, the outer circumference of the first auxiliary member 121 is in an abutting and adhering state with the inner wall of the guiding sheath tube 110, and the tube body of the bending sheath tube 120 and the inner wall of the guiding sheath tube 110 have a spacing, so that the implant 200 connected to the distal end of the bending sheath tube 120 also has a spacing with the inner wall of the guiding sheath tube 110. Since the first auxiliary member 121 is symmetrical about the central axis of the bending sheath tube 120, the distance can avoid the interference between the distal end of the guiding sheath tube 110 and the proximal end of the implant member 200, and the bending sheath tube 120 and the implant member 200 are always located at the central axis of the guiding sheath tube 110, so that the bending sheath tube 120 and the implant member 200 can be smoothly recovered into the guiding sheath tube 110.
Preferably, referring to fig. 3-6, the first auxiliary element 121 comprises a first connecting segment 1211 and a first abutting segment 1212, the first connecting segment 1211 being connected to the bending sheath 120, the first abutting segment 1212 having a maximum outer diameter greater than the inner diameter at the distal opening of the guiding sheath 110. In this embodiment, the first connecting section 1211 is used to connect to the bending sheath 120, and is cylindrical. The first abutting section 1212 is cylindrical, and the outer diameter of the first abutting section 1212 (i.e., the maximum outer diameter of the first auxiliary element 121) is slightly larger than the inner diameter of the guiding sheath 110, so as to ensure concentricity of the bending sheath 120 and the guiding sheath 110, and facilitate recovery of the implant 200 into the guiding sheath 110.
Further, the first abutting section 1212 and the first connecting section 1211 are connected by a first transition surface 1213, and the radial dimension of the first transition surface 1213 gradually increases from the proximal end to the distal end. The first transition surface 1213 and the first abutment section 1212 are in a stepped cylindrical configuration. During the recovery process of the bending sheath 120, a portion of the first transition surface 1213 may contact the distal opening of the bending sheath 120, and the gradually increased size of the first transition surface 1213 is beneficial to the smooth recovery of the bending sheath 120 into the guiding sheath 110, and prevents the first auxiliary member 121 from damaging the distal surface of the guiding sheath 110.
Preferably, the first transition surface 1213 is a convex curved surface, a concave curved surface, or a conical surface. The shape of the first transition surface 1213 aims at realizing good transition and improving the centering performance of the bending sheath 120, and the embodiment sets the first transition surface 1213 as a conical surface, and by reasonably setting the range of the taper α, the effective length of the maximum diameter (i.e. "first abutting section 1212") of the head end of the first auxiliary member 121 can be ensured, thereby ensuring concentricity between the bending sheath 120 and the guiding sheath 110. Too small a taper α may cause a large resistance when the bending sheath 120 is retracted into the introducer sheath 110 and may easily damage the distal surface of the introducer sheath 110, while too large a taper α may affect the effective length of the first abutment section 1212, resulting in reduced concentricity of the bending sheath 120 and the introducer sheath 110. Specifically, the taper angle α of the taper is set to 100-130 °, more preferably 110-120 °, and the length of the first abutment section 1212 ranges from 1.3-1.0mm.
Specifically, the outer wall or the inner wall of the first connection section 1211 is provided with a first protruding strip, and the inner wall or the outer wall of the bending sheath 120 is provided with a corresponding first notch, or the outer wall or the inner wall of the first connection section 1211 is provided with a first notch, and the inner wall or the outer wall of the bending sheath 120 is provided with a corresponding first protruding strip. In this way, the first connecting segment 1211 is connected to the bending sheath 120 by the mating connection of the first protruding strip and the first notch. In this embodiment, the outer wall of the first connecting section 122 is provided with a first notch 12111, and the inner wall of the bending sheath 120 is provided with a corresponding first protruding strip. The first auxiliary member 121 and the bending sheath 120 are connected by the engagement between the first notch 12111 and the first protruding strip, and the pull-out strength of the first connecting section 1211 and the bending sheath 120 can be improved. Further, glue may be poured into the first notch 12111 to fix the first auxiliary member 121 and the bending sheath 120 by gluing. Or, the first connection section 1211 and the bending sheath 120 are fixed by welding, that is, the bending sheath 120 is wrapped and partially melted to the first connection section 1211 of the first auxiliary member 121 by a high temperature, thereby fusing the front end of the bending sheath 120 and the first auxiliary member 121.
Preferably, the distal end of the first abutment section 1212 is provided with a rounded portion 1214 to prevent scratching the vessel and inner wall of the heart. The radius of the arc portion 1214 should be reduced as much as possible to avoid affecting the size of the first abutting section 1212, while ensuring that the first abutting section 1212 has a proper abutting area, so as to achieve a reasonable positioning effect. Preferably, the radius of the rounded portion 1214 ranges from 0.2 to 0.4mm.
Preferably, the length of the first auxiliary element 121 along the axial direction of the bending sheath 120 ranges from 6 to 9mm. It will be appreciated that an excessive length of the first auxiliary element 121 will affect the bending radius of the bending sheath 120, which in turn will cause the distal end of the sheath to abut the wall of the chamber, and an excessive length will result in an insufficient length of the first connecting section 1211 of the first auxiliary element 121, which in turn will affect the connection strength.
The material of the first auxiliary member 121 may be selected from stainless steel material, nickel titanium material or polymer material, and the present embodiment preferably uses stainless steel material having high strength and good workability.
Referring again to fig. 1, the delivery catheter assembly 100 preferably further includes an operating handle 130 disposed at the proximal end of the introducer sheath 110 and a bending handle 140 disposed at the proximal end of the bending sheath 120, respectively. The operating handle 130 is used to adjust the bending and axial movement of the distal portion of the introducer sheath 110, and the bending handle 140 is used to adjust the bending and axial movement of the bending sheath 120, which cooperate with each other to operate outside the patient's body to adjust the relative position between the implant 200 and the treatment site.
Referring again to fig. 1, the present invention also discloses a transcatheter valve repair system 1000 comprising a delivery catheter assembly 100 and an implant 200 of the above-described construction, the delivery catheter assembly 100 being used to deliver the implant 200, the distal end of the deployment sheath 120 being detachably connected to the implant 200. Referring to fig. 12-14, the buckle-accommodating sheath 120 is provided with a third auxiliary element 123, and the distal end of the third auxiliary element 123 is provided with an expandable structure 1231, the expandable structure 1231 having a length of one-fourth to one-half the length of the implant 200.
The implant 200 is detachably disposed at the distal end of the deployment sheath 120, and after the implant 200 reaches the appropriate surgical site and implantation is completed, the implant 200 is separated from the deployment sheath 120, and then the deployment sheath 120 and introducer sheath 110 are retracted, the delivery catheter assembly 100 is withdrawn from the body, leaving the implant 200 in the patient. The purpose of the expandable structure 1231 is to encapsulate the portion of the implant 200 that is susceptible to snagging, reducing damage to the heart during retraction of the implant 200, and the length of the expandable structure 1231 is one-fourth to one-half the length of the implant 200, while conserving material and encapsulating. Because of the individual differences in patient height, age, sex, etc., the heart sizes may also be different, and in order to accommodate different sized hearts, the implant 200 may also be sized differently, with the length of the expandable structure 1231 being proportional to the length of the implant 200, with different sizes and types of implants 200 being suitable.
In one embodiment, implant 200 is a valve clamping device. The distal end of the deployment sheath 120 is provided with a connecting rod 210 for connection to a valve clamping device. The repair of the mitral valve is briefly described below by means of a valve clamp, wherein the valve clamp and the guide wire cooperate to form an external to internal passage, the proximal end of the valve clamp is detachably connected to the connecting rod 210 to connect the valve clamp to the curved sheath 120, the curved sheath 120 is guided along the guide sheath 110 to the vicinity of the mitral valve of the patient in a catheter manner, the valve clamp and the curved sheath 120 are both accommodated in the guide sheath 110 and can move axially relative to the guide sheath 110, and finally the operator clamps the anterior leaflet and the posterior leaflet of the mitral valve together by remotely operating the valve clamp, once the leaflets of the mitral valve are brought together edge to edge, the operator can release the connection between the connecting rod 210 and the valve clamp, so as to release the connection between the curved sheath 120 and the valve clamp, and further implant the valve clamp in the patient to fix the anterior leaflet and the posterior leaflet of the mitral valve together, thereby achieving "edge to edge repair" of the mitral valve. During the implantation process of the valve clamping device, if the valve clamping device fails and cannot clamp the valve leaflet or the clamping position on the valve leaflet is not ideal, the bending sheath tube 120 is properly withdrawn, the first auxiliary piece 121 is abutted against the distal end surface of the guiding sheath tube 110, then the bending sheath tube 120 is continuously withdrawn, at this time, the first auxiliary piece 121 is gradually contained in the guiding sheath tube 110 and always abutted against the inner cavity of the guiding sheath tube 110, so that the concentricity of the bending sheath tube 120 and the guiding sheath tube 110 is corrected, the withdrawal route of the valve clamping device is ensured to be coaxial with the guiding sheath tube 110, interference between the distal end surface of the guiding sheath tube 110 and the clamp arm or other parts of the valve clamping device is avoided, the valve clamping device can be withdrawn into the guiding sheath tube 110 in any direction, and then the distal end position of the guiding sheath tube 110 can be adjusted, and the valve clamping device can be pushed out of the body again or the guiding sheath tube 110 and the valve clamping device as a whole.
Example two
Referring to fig. 7-9, the structure of the catheter assembly 100 according to the second embodiment of the present invention is substantially the same as that of the catheter assembly according to the first embodiment, except that the bending sheath 120 is further provided with a second auxiliary member 122, and the outer wall of the second auxiliary member 122 is in clearance fit with the inner wall of the guiding sheath 110, and the second auxiliary member 122 and the first auxiliary member 121 are sequentially disposed from the near to the far.
It will be appreciated that when the implant 200 fails and the surgical operation cannot be performed, the first auxiliary member 121 and the second auxiliary member 122 cooperate to form a two-point and one-line structure, so as to jointly correct concentricity of the bending sheath 120 and the guiding sheath 110, further ensure that the distal end of the bending sheath 120 and the distal end of the guiding sheath 110 form a straight line channel, ensure that the retracting route of the implant 200 is coaxial with the guiding sheath 110, and further ensure that the implant 200 can be retracted into the guiding sheath 110 in any direction, thereby being more beneficial to the recovery of the implant 200.
Preferably, the second auxiliary element 122 comprises a second abutment section 1221, the outer diameter of the second abutment section 1221 corresponds to the inner diameter of the guiding sheath 110, and the proximal end and the distal end of the second abutment section 1221 are smoothly connected to the outer wall of the bending sheath 120 by means of a second transition surface 1222, respectively. The second auxiliary member 122 has an irregular stepped cylindrical protrusion structure in its outer shape. The purpose of the second transition surface 1222 is to improve the smooth connection between the second abutment 1221 and the body portion of the bending sheath 120, so as to avoid the second abutment 1221 from being jammed against the inner wall of the guiding sheath 110.
Preferably, the length of the secondary member 122 along the axial direction of the buckle accommodating sheath 120 ranges from 5 to 10mm. One reason for this length range is to increase concentricity of the bending sheath 120 and the guiding sheath 110, which facilitates the recovery of the implant 200 into the guiding sheath 110, and the other is to avoid affecting bending performance and bending angle of the bending sheath 120.
Preferably, the distal end of the second auxiliary element 122 and the proximal end of the first auxiliary element 121 are spaced apart by a distance in the range of 16-25mm in the axial direction of the bending sheath 120. The reason for this gap range is to avoid the second auxiliary member 122 from affecting the bending radius and the bending shape of the bending sheath 120. The maximum outer diameter of the second auxiliary element 122 is the same as the inner diameter of the introducer sheath 110, thereby improving concentricity of the bend-adjusting sheath 120 and the introducer sheath 110.
Referring to fig. 9 and 10, after the implant 200, such as a valve clasper device, is in a closed position, concentricity is corrected by the first and second auxiliary elements 121 and 122 and then retrieved into the introducer sheath 110.
Further, referring to fig. 11, in other embodiments, the implant 200 (e.g., a valve clamping device) is typically preloaded into the hollow cartridge 2000 by the manufacturer at the time of shipment, during which the deployment sheath 120 needs to be retracted until the implant 200 is gradually received into the interior of the cartridge 2000, the second auxiliary member 122 can ensure concentricity between the deployment sheath 120 and the interior of the cartridge 2000, assist in gradually retracting the implant 200 into the interior of the cartridge 2000, and prevent the implant 200 from being pulled out from the proximal end of the cartridge 2000 due to excessive retraction of the deployment sheath 120, as the outer diameter of the second auxiliary member 122 is greater than the inner diameter of the silicone valve 2100 at the proximal end of the cartridge 2000, preventing damage to the implant 200.
Example III
Referring to fig. 12-14, a delivery catheter assembly 100 according to a third embodiment of the present invention has substantially the same structure as the delivery catheter assembly according to the first embodiment, except that the bending sheath 120 is further provided with a third auxiliary member 123, the proximal end of the third auxiliary member 123 is connected to the outer wall of the bending sheath 120, and the distal end is provided with an expandable structure 1231. The third auxiliary member 123 is disposed over the distal end of the bending sheath 120, and when the implant 200 is to be retracted, the expandable structure 1231 is expanded and covered around the outer periphery of the implant 200 by the related operation, and then the expandable structure 1231 is retracted under the action of the guiding sheath 110 and is retracted into the guiding sheath 110 together with the implant 200 as it is gradually retracted.
Preferably, the third auxiliary member 123 and the first auxiliary member 121 are disposed in order from the far side to the near side. Since the third auxiliary element 123 is required to wrap the distal implant 200, the third auxiliary element 123 is disposed at the distal end of the buckle sheath 120 and the first auxiliary element 121 is disposed at the opposite proximal end without interfering with the expansion and contraction of the third auxiliary element 123.
Preferably, the third embodiment can be combined with the structure of the second embodiment, wherein the bending sheath 120 comprises a second auxiliary member 122, and the third auxiliary member 123, the first auxiliary member 121 and the second auxiliary member 122 are sequentially arranged from far to near. The first auxiliary element 121, the second auxiliary element 122 and the third auxiliary element 123 cooperate together to ensure that the retraction path of the implant 200 is coaxial with the introducer sheath 110, facilitating the retraction of the implant 200.
Preferably, referring to fig. 15 and 16, the proximal end of the third auxiliary element 123 includes a third connection segment 1232, wherein a third notch is formed in an inner wall or an outer wall of the third connection segment 1232, a corresponding third protrusion is formed on an outer wall or an inner wall of the bending sheath 120, or a third protrusion is formed on an inner wall or an outer wall of the third connection segment 1232, and a corresponding third notch is formed on an outer wall or an inner wall of the bending sheath 120. In this way, the third connecting segment 1232 is connected to the bending sheath 120 by the mating connection of the third protruding strip and the third notch. In this embodiment, the outer wall of the third connecting section 1232 is provided with a third notch, and the inner wall of the bending sheath 120 is provided with a corresponding third protruding strip. The connection between the third protrusion and the third slot 12321 may be referred to as the connection between the first slot 12111 and the first protrusion. The total length of the third connecting segment 1232 is set to 5-6mm, which ensures the connection strength and does not affect the bending performance of the bending sheath 120.
Preferably, the expandable structure 1231 increases in diameter from the proximal end to the distal end, i.e., the expandable structure 1231 is a hollow umbrella-like structure, open at the proximal end, and connected distally to the deployment sheath 120. The maximum outer diameter of the expandable structure 1231 ranges from 25-30mm. The expandable structure 1231 is made of a shape memory material such as nitinol.
The third auxiliary member 123 is manufactured by braiding a plurality of nickel-titanium wires into a tubular structure, placing the tubular structure into an umbrella-shaped shaping mold, shaping at a high temperature of 500-650 ℃, and fixing the tail end of the umbrella-shaped structure and the steel sleeve 1233 together by means of welding, bonding, welding or riveting of high polymer materials.
The third auxiliary member 123 and the bending sheath tube 120 can be welded and fixed by high polymer material, that is, the junction of the bending sheath tube 120 and the third auxiliary member 123 is melted by high temperature, so that the front end of the bending sheath tube 120 and the third auxiliary member 123 are fused together.
Referring to fig. 17, the implant 200 is a valve clamping device, when the valve clamping device fails and cannot clamp the valve leaflet or the clamping position is not ideal, the valve clamping device needs to be withdrawn to be re-accommodated in the guiding sheath 110, and at this time, the third auxiliary member 123 is changed from an umbrella-shaped structure to a cylindrical structure by withdrawing the bending sheath 120, and the third auxiliary member 123 completely wraps the proximal end of the valve clamping device, so as to retract the valve clamping device into the guiding sheath 110.
Further, referring to fig. 18 and 19, after the valve clasping device is released, the distal end of the bending sheath 120 is fully exposed for the connecting rod 210 connected to the valve clasping device, and the delivery catheter assembly 100 is completely withdrawn from the patient, and the third auxiliary member 123 can fully wrap the connecting rod 210 during the retraction of the bending sheath 120, thereby avoiding the connecting rod 210 from scratching the leaflet and the atrial wall, improving the safety of the apparatus and reducing the risk of surgery.
Still further, referring to fig. 20, when the transcatheter valve repair system according to the present embodiment is used for mitral valve edge-to-edge repair, the third auxiliary member 123 may press the leaflet at the atrial side before the valve clamping device clamps the anterior leaflet and the posterior leaflet of the mitral valve, thereby reducing the swing amplitude of the anterior leaflet and the posterior leaflet, facilitating the valve clamping device to clamp the leaflet, reducing the implantation difficulty, and improving the success rate of the operation.