Valve prosthesis delivery system

Abstract

The utility model discloses a valve prosthesis conveying system which comprises a conveyor and a valve prosthesis. The conveyor comprises an inner rod and an outer sheath tube arranged outside the inner rod in a sleeving mode. The far end of the inner rod is connected with a containing head, and the containing head and the far end of the outer sheath tube are arranged in a spaced mode in the axial direction. The valve prosthesis comprises a support, a covering film and a valve leaflet assembly, wherein the covering film and the valve leaflet assembly are connected to the support. The stent comprises an expansion section arranged at the inflow end of the valve prosthesis, and the outer diameter of the expansion section is gradually increased in the direction from the outflow end to the inflow end of the valve prosthesis. When the valve prosthesis conveying system is in a conveying state, the expansion section of the valve prosthesis is collected in the containing head, and the edge of the near end of the expansion section is aligned with the edge of the near end of the containing head. The valve prosthesis provided by the utility model is high in fitting degree with human tissues and good in sealing performance.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of interventional medical devices, in particular to a valve prosthesis delivery system. BACKGROUND

[0002] This section provides background information only and can not necessarily be prior art.

[0003] When a native heart valve narrows, or a native valve leaks or regurgitates (e.g., due to calcification of the valve leaflets), a heart valve replacement can be performed. In one treatment approach, the native valve can be excised and replaced with a valve prosthesis. The valve prosthesis includes a stent, a covering, and valve leaflets, where the profile of the stent affects the stability of the valve prosthesis in the treatment site. In addition, the profile of the stent affects the sealing performance of the valve prosthesis. A valve prosthesis with poor sealing performance can cause paravalvular leakage, which can prevent the valve prosthesis from achieving the desired anti-regurgitation effect. SUMMARY

[0004] Therefore, it is necessary to provide a valve prosthesis with good fit and a valve prosthesis delivery system.

[0005] The present application provides a valve prosthesis delivery system, which comprises:

[0006] A delivery device, which comprises an inner rod and an outer sheath tube sleeved on the outer side of the inner rod; the distal end of the inner rod is connected with a receiving head, and the receiving head is axially spaced apart from the distal end of the outer sheath tube;

[0007] A valve prosthesis, which comprises a stent, a covering connected to the stent, and a valve leaflet assembly connected to the stent; the stent comprises an outflow end portion, a main body portion, and an inflow end portion connected in sequence, the inflow end portion comprises a connecting section and an expanding section, and the connecting section connects the main body portion and the expanding section; the outer diameter of the expanding section gradually increases from the outflow end to the inflow end of the valve prosthesis;

[0008] When the valve prosthesis delivery system is in a delivery state, the expanding section of the valve prosthesis is contained in the receiving head, and the proximal end edge of the expanding section is aligned with the proximal end edge of the receiving head.

[0009] In one embodiment, the expanding section has a first height in the axial direction of the valve prosthesis, and the valve prosthesis has an overall height, and the first height accounts for 5% to 20% of the overall height.

[0010] In one embodiment, the expanding section further comprises a distal end edge opposite to the proximal end edge, the proximal end edge has a proximal end outer diameter, and the distal end edge has a distal end outer diameter, and the distal end outer diameter exceeds the proximal end outer diameter by 0.5% to 5%.

[0011] In one embodiment, the inflow end portion comprises a plurality of axial support struts, each of the axial support struts comprising an axial segment and an inclined segment; the axial segment extends along an axial direction of the valve prosthesis, the inclined segment is connected to a distal end of the axial segment, and a proximal end of the inclined segment extends away from a central axis of the valve prosthesis; proximal ends of the plurality of inclined segments form a proximal edge of the expansion segment.

[0012] In one embodiment, the inclined segment comprises an arc-shaped structure at the proximal end of the inclined segment for connecting to the axial segment.

[0013] In one embodiment, the connecting segment comprises a first wave, the first wave comprising a plurality of first wave peaks, first wave stems and first wave valleys connected to each other.

[0014] In one embodiment, the expansion segment comprises a second wave, the second wave comprising a plurality of second wave peaks, second wave stems and second wave valleys connected to each other, the second wave valleys being connected to the first wave valleys through the axial support struts.

[0015] In one embodiment, the delivery device further comprises a core tube, the core tube being sleeved outside the inner rod and disposed inside the outer sheath; in a circumferential direction, a distal end of the outer sheath and the core tube define a first receiving portion, and when the valve prosthesis delivery system is in a delivery state, an outflow end portion of the valve prosthesis is at least partially accommodated in the first receiving portion.

[0016] In one embodiment, the accommodation head comprises a tubular connecting portion and a tubular housing portion annularly sleeved outside the tubular connecting portion, a distal end of the tubular connecting portion being connected to a distal end of the tubular housing portion, and a proximal end of the tubular connecting portion being connected to the inner rod; in a circumferential direction, an inner wall of the tubular housing portion and an outer wall of the tubular connecting portion form a proximally open annular cavity, i.e., a second receiving portion, and when the valve prosthesis delivery system is in a delivery state, an expansion segment of the valve prosthesis is accommodated in the second receiving portion.

[0017] In one embodiment, the delivery device further comprises a handle assembly connected to a proximal end of the core tube; the handle assembly comprises a first driving assembly and a second driving assembly, the first driving assembly being connected to the outer sheath and being used to drive the outer sheath to move relative to the core tube, and the second driving assembly being connected to the inner rod and being used to drive the inner rod to move relative to the core tube.

[0018] The valve prosthesis of the utility model is provided with an outwardly expanding expansion section near the inflow end, so that when the valve prosthesis is placed in the human body, the expansion section of the valve prosthesis is similar in shape to the left ventricular outflow tract in the aortic root, and the degree of fit is high. On the other hand, the valve prosthesis of the utility model is preassembled in a delivery device, and because the expansion section in the accommodating head expands outward, even if the expansion section is pressed in the accommodating head for a long time, the radial size of the heart valve after being released is greater than or equal to the expected radial size. BRIEF DESCRIPTION OF DRAWINGS

[0019] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the drawings needed to be used in the embodiments or the prior art description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments described in the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0020] Figure 1 It is an embodiment of the valve prosthesis delivery system structure diagram of the utility model;

[0021] Figure 2 It is an embodiment of the delivery device structure diagram of the utility model;

[0022] Figure 3 It is an embodiment of the film structure diagram of the utility model;

[0023] Figure 4 It is an embodiment of the support structure diagram of the utility model;

[0024] Figure 5 It is Figure 1 The sectional view of A in the figure (where the valve prosthesis does not show the sectional view);

[0025] Figure 6 It is Figure 5 The enlarged view of B in the figure;

[0026] Figure 7 It is an embodiment of the valve prosthesis placed in the human body of the utility model;

[0027] Figure 8 It is Figure 4 The enlarged view of C in the figure;

[0028] Figure 9 It is an embodiment of the axial rod structure diagram of the utility model. DETAILED DESCRIPTION

[0029] In order to make the above object, features and advantages of the present application more obvious and understandable, the specific embodiments of the present application will be described in detail below with reference to the drawings. In the following description, a large number of specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be implemented in many different ways other than those described herein, and those skilled in the art can make similar improvements without departing from the spirit of the present application, so the present application is not limited to the specific implementations disclosed below.

[0030] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present application belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present application.

[0031] In the field of interventional medical devices, the "distal end" is typically defined as the end of the device that is distal to the operator during a procedure, and the "proximal end" is typically defined as the end of the device that is proximal to the operator during a procedure. A valve prosthesis typically includes an open state and a closed state, wherein blood flow can pass through the valve prosthesis when the valve prosthesis is in the open state, and blood flow is blocked by the valve prosthesis when the valve prosthesis is in the closed state.

[0032] The present embodiment provides a valve prosthesis delivery system 100, as shown in Figure 1 The valve prosthesis delivery system 100 includes a delivery device 10 and a valve prosthesis 20.

[0033] As shown in Figure 2 The delivery device 10 includes an inner rod 110 and an outer sheath 120 sleeved on the outer sheath 120; the distal end of the inner rod 110 is connected with a receiving head 130, and the receiving head 130 is axially spaced apart from the distal end of the outer sheath 120.

[0034] As shown in Figure 3 The valve prosthesis 20 includes a stent 210, a covering 220 connected to the stent 210, and a leaflet assembly 230. The leaflet assembly 230 includes a plurality of valve leaflets, all or part of which are made of biological materials, biocompatible synthetic materials, or other such materials. Suitable biological materials can include, for example, bovine pericardium (or pericardium of other origin). The covering includes one or more of PET, e-PTFE, biological materials, etc. Referring to Figure 3 , the end of the valve prosthesis 20 through which blood flows is defined as the inflow end 240, and the end of the valve prosthesis 20 through which blood flows is defined as the outflow end 250. As shown in Figure 4As shown, the stent 210 comprises an outflow end 211, a main body 212 and an inflow end 213 connected in sequence. The inflow end 213 comprises a connecting section 2131 and an expansion section 2132, the connecting section 2131 connecting the main body 212 and the expansion section 2132; the outer diameter of the expansion section 2132 gradually increases from the outflow end 250 to the inflow end 240 of the valve prosthesis 20.

[0035] In combination Figures 4 to 6 As shown, when the valve prosthesis delivery system 100 is in a delivery state, the expansion section 2132 of the valve prosthesis 20 is contained in the accommodation head 130, and the proximal edge 21321 of the expansion section 2132 is aligned with the proximal edge 131 of the accommodation head 130. For ease of understanding, Figure 4 The dashed line in the figure represents the proximal edge 21321 of the expansion section 2132.

[0036] The valve prosthesis 20 of the utility model is provided with the outwardly expanding expansion section 2132 near the inflow end 240, so that the expansion section 2132 is placed in the human body by the valve prosthesis 20, as Figure 7 As shown, the expansion section 2132 of the valve prosthesis 20 is similar in shape to the left ventricular outflow tract 01 in the aortic root, and has high adhesion. On the other hand, the valve prosthesis 20 of the utility model is preloaded in the delivery device 10, the proximal edge 21321 of the expansion section 2132 is aligned with the proximal edge 131 of the accommodation head 130, that is, the expansion section 2132 is located in the accommodation head 130 as a whole. Since the expansion section 2132 located in the accommodation head 130 expands outwardly, it provides a certain allowance for the deformation of the valve prosthesis 20, so that even if the expansion section 2132 is pressed in the accommodation head 130 for a long time, the radial size of the valve prosthesis 20 after being released will not be smaller than the expected radial size. In addition, as Figure 6 As shown, the transition position of the expansion section 2132 and the connecting section 2131, that is, the proximal edge 21321 of the expansion section 2132, has a bending structure, and the proximal edge 131 of the accommodation head 130 just abuts against the proximal edge 21321 of the expansion section 2132, so that it can avoid the proximal edge 131 of the accommodation head 130 pressing on other parts of the valve prosthesis 20 to produce indentations or corners on the valve prosthesis 20.

[0037] In the embodiment, the stent 210 of the valve prosthesis 20 is formed by laser cutting of a metal tube and is shaped by heat treatment to have an outwardly expanding expansion section 2132. In other embodiments, the stent 210 is formed by braiding of metal wires.

[0038] Looking back Figure 4In the natural state, the expansion section 2132 has a first height H1 in the axial direction of the valve prosthesis 20, the valve has a total height H, and the first height H1 accounts for 5 to 20 percent of the total height H. In this embodiment, the first height H1 accounts for 10 percent of the total height H. The expansion section 2132 has a suitable height that is more in line with the physiological structure of the human body, so that the valve prosthesis 20 is more in line with the human tissue.

[0039] In the natural state, the expansion section 2132 further includes a distal edge 21322 opposite the proximal edge 21321, the proximal edge 21321 has a proximal outer diameter D, and the distal edge 21322 has a distal outer diameter D1, the distal outer diameter D1 exceeds the proximal outer diameter D by 0.5 to 5 percent. The valve prosthesis delivery system 100 of the present application is a pre-packaged system, and before the valve prosthesis 20 is used, the expansion section 2132 is long time bundled in the accommodation head 130, and in this embodiment, in the natural state, the distal outer diameter of the expansion section 2132 exceeds the proximal outer diameter by 3.5 percent, and when the valve prosthesis 20 is released, the distal outer diameter of the expansion section 2132 still exceeds the proximal outer diameter by 3 percent, ensuring that the expansion section 2132 has an expanded shape to fit the human tissue.

[0040] It should be noted that the natural state described above refers to the state when the valve prosthesis 20 has not been bundled in the delivery device 10 and is not extruded by other external forces.

[0041] As shown in Figure 8 The inflow end 213 includes a plurality of axial support rods 2133, each of which includes an axial section 21331 and an inclined section 21332; the axial section 21331 extends in the axial direction of the valve prosthesis 20, and the proximal end of the inclined section 21332 is connected to the distal end of the axial section 21331, and the distal end of the inclined section 21332 extends away from the central axis of the valve prosthesis 20; it can be understood that the inclined section 21332 is bent radially outward relative to the axial section 21331 to form an outwardly expanding structure. The proximal ends of a plurality of inclined sections 21332 are circumferentially arranged around the valve prosthesis 20 to form the proximal edge 21321 of the expansion section 2132. In this embodiment, as shown in Figure 9As shown, the inclined segment 21332 includes an arc-shaped structure 21332a, which is located at the proximal end of the inclined segment 21332 and is used to connect with the axial segment 21331. The axial segment 21331 and the inclined segment 21332 are transitionally connected through the arc-shaped structure 21332a, which can avoid stress concentration. In other embodiments, the axial segment 21331 and the inclined segment 21332 are directly connected (a schematic diagram of the direct connection of the axial segment 21331 and the inclined segment 21332 is not shown in the accompanying drawings).

[0042] like Figure 8 As shown, the connecting segment 2131 includes a first wave loop 2134, which includes multiple interconnected first wave peaks 21341, first wave rods 21342, and first wave troughs 21343.

[0043] The expansion section 2132 includes a second wave ring 2135, which includes multiple interconnected second wave peaks 21351, second wave rods 21352, and second wave troughs 21353. The second wave trough 21353 is connected to the first wave trough 21343 through the shaft support rod 2133.

[0044] like Figure 8 As shown, the first peak 21341 is a free end. Therefore, bending of the first wave rod 21342 may cause the first peak 21341 to shift radially outward or inward. Similarly, bending of the second wave rod 21352 may cause the second peak 21351 to shift radially outward or inward. In this embodiment, in the axial direction of the valve prosthesis 20, the proximal edge of the expansion segment 2132 is located between the first trough 21343 and the second peak 21351, and avoids the first trough 21343 and the second peak 21351. This can prevent the first wave rod 21342 and the second wave rod 21352 from bending, thereby preventing the first peak 21341 or the second peak 21351 from shifting, and ensuring that the valve prosthesis 20 maintains the preset shape after deployment.

[0045] Looking back Figure 5 and Figure 6 The delivery device 10 further includes a core tube 140, which is sleeved outside the inner rod 110 and disposed inside the outer sheath tube 120. In the circumferential direction, a first receiving portion 121 is defined between the distal end of the outer sheath tube 120 and the core tube 140. When the valve prosthesis delivery system 100 is in the delivery state, the outflow end 211 of the valve prosthesis 20 is at least partially confined within the first receiving portion 121.

[0046] Looking back Figure 6The accommodation head 130 comprises a tubular connecting portion 132 and a tubular housing portion 133 arranged around the tubular connecting portion 132, the distal end of the tubular connecting portion 132 is connected with the distal end of the tubular housing portion 133, and the proximal end of the tubular connecting portion 132 is connected with the inner rod 110; in the circumferential direction, the annular cavity with a proximal opening is formed between the inner wall of the tubular housing portion 133 and the outer wall of the tubular connecting portion 132, which is the second accommodation portion 134, and when the valve prosthesis delivery system 100 is in the delivery state, the expanded section 2132 of the valve prosthesis 20 is accommodated in the second accommodation portion 134.

[0047] Looking back Figure 2 The delivery device 10 further comprises a handle assembly 150 connected with the proximal end of the core tube 140; the handle assembly 150 comprises a first driving assembly 160 and a second driving assembly 170, the first driving assembly 160 is connected with the outer sheath 120 and is used to drive the outer sheath 120 to move relative to the core tube 140, and the second driving assembly 170 is connected with the inner rod 110 and is used to drive the inner rod 110 to move relative to the core tube 140.

[0048] It should be noted that during the release of the valve prosthesis 20, the outer sheath 120 is driven to move by operating the first driving assembly 160 to release the proximal end of the valve prosthesis 20, and the accommodation head 130 is driven to move by operating the second driving assembly 170 to release the distal end of the valve prosthesis 20. Therefore, the delivery device 10 proposed in the embodiment can sequentially release the distal end and the proximal end of the valve prosthesis 20 by operating the second driving assembly 170 and the first driving assembly 160, i.e., first operating the second driving assembly 170 to release the distal end of the valve prosthesis 20, and then operating the first driving assembly 160 to release the proximal end of the valve, so that when the distal end of the valve prosthesis 20 is released, if there is a large deviation in the deployment position of the valve prosthesis 20, the valve prosthesis 20 in the half-expanded state (i.e., the state that the distal end of the valve prosthesis 20 is expanded, and the proximal end of the valve prosthesis 20 is accommodated in the first accommodation portion) can still be pulled or pushed by the core tube and the outer sheath 120 to adjust the position of the valve prosthesis 20, and when the valve prosthesis 20 reaches the ideal position, the proximal end of the valve prosthesis 20 is finally released, so that the position accuracy of the released valve prosthesis 20 is more accurate, and the operation quality is improved.

[0049] The technical features of the above-described embodiments can be combined in any manner. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described, but as long as the combinations of the technical features do not exist contradictions, they should be considered as the scope of the present disclosure.

[0050] The above-described embodiments only express several implementation manners of the utility model, the description is more specific and detailed, but can not therefore be understood as the limitation of the utility model patent range. It should be pointed out that for ordinary skilled person in the art, without departing from the utility model concept, several modifications and improvements can be made, which belong to the protection range of the utility model. Therefore, the protection range of the utility model patent should be subject to the appended claims.

Claims

1. A valve prosthesis delivery system, characterized by, The valve prosthesis delivery system comprises: a delivery device comprising an inner rod and an outer sheath sleeved outside the inner rod; a receiving head is connected to a distal end of the inner rod, and the receiving head is axially spaced apart from a distal end of the outer sheath; a valve prosthesis comprising a stent and a covering and a leaflet assembly connected to the stent; the stent comprises an outflow end portion, a main body portion and an inflow end portion connected in sequence, the inflow end portion comprises a connecting section and an expanding section, the connecting section connects the main body portion and the expanding section; an outer diameter of the expanding section gradually increases from an outflow end to an inflow end of the valve prosthesis. When the valve prosthesis delivery system is in a delivery state, the expanding section of the valve prosthesis is contained in the receiving head, and a proximal end edge of the expanding section is aligned with a proximal end edge of the receiving head.

2. The valve prosthesis delivery system according to claim 1, wherein: in a natural state, the expanding section has a first height in an axial direction of the valve prosthesis, the valve has an overall height, and the first height accounts for 5% to 20% of the overall height.

3. The valve prosthesis delivery system according to claim 2, wherein: in the natural state, the expanding section further comprises a distal end edge opposite to the proximal end edge, the proximal end edge has a proximal end outer diameter, and the distal end edge has a distal end outer diameter, the distal end outer diameter exceeds the proximal end outer diameter by 0.5% to 5%.

4. The valve prosthesis delivery system according to claim 1, wherein: the inflow end portion comprises a plurality of axial support rods, each of the axial support rods comprises an axial section and an inclined section; the axial section extends along the axial direction of the valve prosthesis, a proximal end of the inclined section is connected to a distal end of the axial section, and a distal end of the inclined section extends away from a central axis of the valve prosthesis; proximal ends of the plurality of inclined sections form the proximal end edge of the expanding section in a circumferential direction of the valve prosthesis.

5. The valve prosthesis delivery system according to claim 4, wherein: the inclined section comprises an arc-shaped structure at the proximal end of the inclined section for connecting to the axial section.

6. The valve prosthesis delivery system according to claim 5, wherein: the connecting section comprises a first wave ring, and the first wave ring comprises a plurality of first wave crests, first wave stems and first wave troughs connected to each other.

7. The valve prosthesis delivery system according to claim 6, wherein: the expanding section comprises a second wave ring, and the second wave ring comprises a plurality of second wave crests, second wave stems and second wave troughs connected to each other, and the second wave troughs are connected to the first wave troughs through the axial support rods.

8. The valve prosthesis delivery system according to claim 1, wherein: the delivery device further comprises a core tube, the core tube is sleeved outside the inner rod, and the core tube is arranged in the outer sheath; in a circumferential direction, a distal end of the outer sheath and the core tube define a first receiving portion, and when the valve prosthesis delivery system is in the delivery state, the outflow end portion of the valve prosthesis is at least partially contained in the first receiving portion.

9. The valve prosthesis delivery system of claim 8, wherein: the housing head comprises a tubular connecting portion and a tubular housing portion annularly arranged outside the tubular connecting portion, a distal end of the tubular connecting portion is connected with a distal end of the tubular housing portion, a proximal end of the tubular connecting portion is connected with the inner rod; in a circumferential direction, an annular cavity with a proximal opening is formed between an inner wall of the tubular housing portion and an outer wall of the tubular connecting portion, which is the second receiving portion, when the valve prosthesis delivery system is in a delivery state, the expanded section of the valve prosthesis is received in the second receiving portion.

10. The valve prosthesis delivery system of claim 8, wherein: the delivery device further comprises a handle assembly connected with a proximal end of the core tube; the handle assembly comprises a first driving assembly and a second driving assembly, the first driving assembly is connected with the outer sheath and is used to drive the outer sheath to move relative to the core tube, the second driving assembly is connected with the inner rod and is used to drive the inner rod to move relative to the core tube.

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