CN210277410U - Loading device - Google Patents
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- CN210277410U CN210277410U CN201920751824.0U CN201920751824U CN210277410U CN 210277410 U CN210277410 U CN 210277410U CN 201920751824 U CN201920751824 U CN 201920751824U CN 210277410 U CN210277410 U CN 210277410U
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Abstract
The utility model provides a loading attachment for compressing implant. The loading device comprises: a guide cap having an inner lumen, a distal opening and a proximal opening, the inner lumen communicating with the distal opening and the proximal opening, and the distal opening being smaller than the proximal opening; a base for urging the implant to move within the internal cavity of the guide cap from the proximal opening of the guide cap to the distal opening of the guide cap; and the height adjusting piece group is detachably connected with the base and is used for adjusting the axial distance between the proximal end of the implant and the base. The utility model provides a loading attachment has the high characteristics of universality.
Description
Technical Field
The utility model relates to the technical field of medical equipment, in particular to loading device.
Background
The heart valve is the main door of the heart blood circulation, once stenosis or incomplete closure occurs, the heart can have insufficient power or failure, and heart valve diseases such as chest distress, asthma, general edema, weakness, chest pain and the like occur. The development of human disease treatment techniques is a general rule and usually undergoes a process from none, to any, large to small, and even non-invasive. Likewise, valvular heart disease has undergone the earliest untreatable procedure followed by traditional median sternotomy surgery and recent minimally invasive (small incision) surgical procedures, and is currently in the era of transcatheter valve intervention. If the traditional median sternotomy incision operation is called 1.0 era of heart valvulopathy treatment and the minimally invasive valve operation is called 2.0 era of heart valvulopathy treatment, the transcatheter valve intervention treatment can be called 3.0 era of heart valvulopathy treatment. In the last decade, the interventional treatment of international transcatheter valvular diseases has been a great progress through continuous exploration, and becomes the branch of the most promising development in the field of interventional cardiology. Over 30 million patients worldwide have benefited from this treatment since the first interventional valve replacement procedure was performed in france in 2002.
The principle of transcatheter valve interventional therapy is that a valve prosthesis is loaded into a delivery system, the valve prosthesis is delivered to a lesion position in a transcatheter mode, and the valve prosthesis is released to the lesion position to replace a primary valve with degraded function, so that the heart function of a patient is improved. The transcatheter valve interventional therapy can treat the valvular heart disease under the conditions of no thoracotomy and no heartbeat, thereby avoiding the huge trauma to patients caused by the thoracotomy and the heartbeat arrest in the prior surgery.
Transcatheter valve interventions require the valve prosthesis to be pre-compressed to a small diameter by a loading device for loading into the sheath of the delivery system, and are often prone to situations in which the outflow tract of the valve prosthesis is difficult to retract into the sheath of the delivery system during operation and requires repeated loading. The valve prosthesis is repeatedly loaded, so that the loading time is easily increased, the loading process is difficult to operate, and the loading efficiency is low. In addition, the existing loading device is only suitable for the valve prosthesis with single shape and size, and the universality of the loading device is low.
SUMMERY OF THE UTILITY MODEL
An object of the utility model is to provide a loading device to solve the low problem of current loading device universality.
In order to solve the above technical problem, the utility model provides a loading device for the compression implant, include: a guide cap having an inner lumen, a distal opening and a proximal opening, the inner lumen communicating with the distal opening and the proximal opening, and the distal opening being smaller than the proximal opening; a base for urging the implant to move within the internal cavity of the guide cap from the proximal opening of the guide cap to the distal opening of the guide cap; and the height adjusting piece group is detachably connected with the base and is used for adjusting the axial distance between the proximal end of the implant and the base.
Optionally, the height adjusting set comprises at least one height adjusting member, and the height adjusting members can be overlapped with each other.
Optionally, the height adjusting member comprises a main body member and at least one insert member, the insert member is connected to the main body member, the insert member is detachably connected to the base or other height adjusting members, and the main body member is used for adjusting the height of the height adjusting member group from the proximal end to the distal end.
Optionally, in the single height adjusting member, the insert is rotatably connected to the main body member, a concave structure is disposed on the main body member, a concave shape and a setting position of the concave structure are matched with a shape and a setting position of the insert, and the insert is received in the concave structure after being rotated.
Optionally, the body member has an inner cavity, and the proximal opening of the body member communicates with the inner cavity.
Optionally, the body member has an inner cavity, and the proximal opening of the body member communicates with the inner cavity, wherein the small-sized height adjustment member can pass through the proximal opening of the body member of the large-sized height adjustment member and be disposed in the inner cavity of the body member of the large-sized height adjustment member.
Optionally, the guiding cover comprises a connecting section and a compressing section, which are sequentially arranged from the proximal opening to the distal opening of the guiding cover, the connecting section is used for being matched with the base and guiding the base to move in the inner cavity of the guiding cover, and the compressing section is used for compressing the implant.
Optionally, a groove is formed in the base, the height adjusting member set is detachably connected to the groove, and the height adjusting member set is used for adjusting an axial distance between the proximal end of the implant and the bottom of the groove.
Optionally, the base includes the collet, sets up the joining region on the collet, and sets up the guide post on the joining region, collet, joining region and guide post set gradually from the near-end of base to the distal end, under the loading state, the near-end of base passes the near-end opening of guide lid inserts and establishes in the inner chamber of guide lid, the guide post with the joining region holds in the inner chamber of guide lid.
Optionally, the groove is opened on a distal end face of the connection region.
Optionally, the bottom of the groove is provided with at least one inwards-recessed embedding hole, and the embedding hole is used for being connected with the height adjusting group.
The utility model provides a pair of loading device has following beneficial effect:
first, since the height adjusting member set is detachably connected to the base, and the height adjusting member set is used for adjusting the distance between the proximal end of the implant and the base, when the loading device compresses the implant, the distance between the base and the guiding cover of the implant is changed from the original distance between the base and the distal opening of the guiding cover to the distance between the distal end of the height adjusting member set and the distal opening of the guiding cover, so that the loading device with one shape and size can be used for compressing the implant with one shape and size when the height adjusting member set is not arranged, and can be used for compressing the implant with another shape and size when the height adjusting member set is arranged, thereby improving the universality of the loading device.
Secondly, the height of the height adjusting component group is changed from the near end to the far end, the height adjusting components are mutually overlapped, so that the height of the height adjusting component group can be adjusted, the height adjusting component group after height adjustment is arranged in the base, the distance between the far end of the height adjusting component group and the far end opening of the guide cover can be changed along with the height change of the height adjusting component group, and the loading device with one shape and size can be suitable for implants with different shapes and sizes in a pre-compression mode.
And the main body part is provided with an inner cavity, and the proximal end opening of the main body part is communicated with the inner cavity, wherein the height adjusting part with small size can pass through the proximal end opening of the main body part of the height adjusting part with large size and is arranged in the inner cavity of the main body part of the height adjusting part with large size, so that the height adjusting part can be stacked and sleeved together by utilizing the inner cavity of the main body part to be accommodated when being packaged, and the space occupied by the height adjusting part can be reduced.
Drawings
FIG. 1 is a schematic view of the valve prosthesis after release;
FIG. 2 is a schematic view of the loading device with a valve prosthesis disposed therein;
FIG. 3 is a schematic cross-sectional view of one embodiment of the present invention showing a valve prosthesis disposed in the loading device;
fig. 4 is a schematic structural view of a guide cover according to an embodiment of the present invention;
fig. 5 is a schematic structural diagram of a base according to an embodiment of the present invention;
FIG. 6 is a schematic view of a height adjustment member according to an embodiment of the present invention;
FIG. 7 is a schematic view of the structure of the insert setting body member of the height adjuster in the concave structure according to one embodiment of the present invention;
fig. 8 is a schematic structural view illustrating the connection between the height adjusting member set and the base according to an embodiment of the present invention;
fig. 9 is a schematic structural view illustrating the connection between the base and the guide cover according to an embodiment of the present invention;
FIG. 10 is a schematic view of a valve prosthesis partially crimped within a sheath of a delivery system according to one embodiment of the present invention;
fig. 11 is a schematic view of a valve prosthesis according to an embodiment of the present invention, fully crimped within a sheath of a delivery system.
Description of reference numerals:
100-a valve prosthesis;
110-a scaffold; 111-inflow channel; 112-outflow tract; 113-hanging ears;
120-leaflet;
200-a loading device;
210-a guide cover; 211-lumen; 212-distal opening; 213-proximal opening;
220-a base; 221-grooves;
300-a guide cover; 310-an inner cavity; 320-distal opening; 330-proximal opening; 340-a connecting segment; 350-a compression section;
400-a base; 410-grooves; 430-shoe; 440-a joining zone; 450-a guide post; 460-opening a hole;
500-a set of height adjusters;
510-height adjustment; 511-a body piece; 512-an insert; 513-an insertion hole; 514-insertion holes;
600-a valve prosthesis; 610-a proximal end of the valve prosthesis; 620-distal end of valve prosthesis;
700-sheath tube.
Detailed Description
Referring to fig. 1, fig. 1 is a schematic view of a valve prosthesis 100 after release, which may be crimped in a catheter of a delivery system and implanted in a body via the catheter. Although the valve prosthesis 100 shown in the figures is a valve prosthesis 100 having a relatively common shape, the shape of the valve prosthesis 100 of the present invention is not limited to any particular shape. The valve prosthesis 100 includes a stent 110 in a mesh tube shape and a leaflet 120 covering an outer surface of the stent 110, and the stent 110 includes an inflow channel 111 and an outflow channel 112 connected in sequence, and a tab 113 extending from one end of the outflow channel 112 in a direction away from the inflow channel 111. The material for making the bracket 110 of the present invention is not particularly limited, and may be any material existing in the field, for example, a shape memory alloy. The material for forming the leaflet 120 is not particularly limited, and may be any material known in the art, for example, collagen fibers of animal origin.
Typically, valve prosthesis 100 is pre-compressed by a loading device, loaded into a delivery system and crimped within a sheath of the delivery system, with valve prosthesis 100 crimped within the sheath in a collapsed state, after which valve prosthesis 100 is delivered by the delivery system into the body, and then released from the catheter and expanded into the configuration shown in fig. 1.
The delivery system generally includes an inner tube and a sheath that is disposed outside the inner tube and is movable relative to the inner tube, the sheath being configured to crimp the valve prosthesis 100 between the sheath and the inner tube. Typically, the valve prosthesis 100 is loaded onto the inner tube pre-compressed prior to crimping the valve prosthesis 100 into the sheath, and secured to a fixation head in the inner tube, after which the valve prosthesis 100 is crimped between the sheath and the inner tube by relative movement of the sheath and the inner tube.
Referring to fig. 2, fig. 2 is a schematic view of a loading device with a valve prosthesis compressed therein, the loading device 200 generally comprising a guide cap 210 and a base 220. The guiding cap 210 has an inner cavity 211, a distal opening 212 and a proximal opening 213, the inner cavity 211 of the guiding cap 210 is communicated with the distal opening 212 and the proximal opening 213 of the guiding cap 210, and the distal opening 212 of the guiding cap 210 is smaller than the proximal opening 213 of the guiding cap 210. The base 220 is used for pushing the implant to move in the inner cavity 211 of the guiding cover 210 from the proximal opening 213 of the guiding cover 210 to the distal opening 212 of the guiding cover 210, and a groove 221 is formed on the base 220. The loading device 200 has a loading state in which: the proximal end of the base 220 is inserted into the inner cavity 211 of the guide cover 210 through the proximal opening 213 of the guide cover 210, the portion of the implant near the distal end is pressed into the guide cover 210, the portion of the implant near the proximal end is disposed in the groove 221 of the base 220, and the proximal end of the implant is in contact with the bottom of the groove 221.
During pre-compression of valve prosthesis 100 by loading device 200, valve prosthesis 100 is pre-compressed under the cooperation of guide cap 210 and base 220. Specifically, during pre-compression, the portion of the valve prosthesis 100 near the proximal end is generally disposed in the groove 221 of the base 220, the proximal end of the valve prosthesis 100 is in contact with the bottom of the groove 221, the portion of the valve prosthesis 100 near the distal end is generally crimped in the guide cap 210, and during the gradual insertion and approach of the proximal end of the base 220 into the guide cap 210, the distal end of the valve prosthesis 100 is gradually compressed by the guide cap 210 and squeezed out of the distal opening 212 of the guide cap 210 until the distal ends of the lugs 113 and the distal end of the outflow tract 112 are brought into a closed state, whereby the pre-compression of the valve prosthesis 100 is substantially completed. In a closed state, the radial dimension of the distal end of the hanging lug 113 and the distal end of the outflow tract 112 is smaller than the inner diameter of the sheath of the delivery system, and the hanging lug 113 of the valve prosthesis 100 can be just tightly attached, so that the hanging lug 113 can be conveniently fixed on a fixing head in the delivery system, and after the hanging lug 113 is fixed on the fixing head, the attaching force between the hanging lug 113 and the fixing head can ensure that the distal end of the outflow tract 112 of the valve prosthesis 100 is tightly attached to the inner tube of the delivery system, so that the valve prosthesis 100 can be conveniently and firmly fixed in the delivery system, and the sheath can easily press and hold the valve prosthesis 100.
The size of the loading device 200 must be accurately measured because, if the depth of the groove 221 of the base 220 is too deep and limited to the extent that the base 220 is inserted into the guide cap 210, the minimum axial distance between the bottom of the groove 221 and the distal opening 212 of the guide cap 210 is fixed, when the valvular prosthesis 100 is too small, the valvular prosthesis 100 is easily compressed insufficiently, the precompression fails, and the compressed size of the distal ends of the hangers 113 and the distal end of the outflow tract 112 is larger than the inner diameter of the sheath of the delivery system, so that the outflow tract 112 cannot be completely received in the sheath. If the depth of the groove 221 of the base 220 is too shallow, limited to the extent that the base 220 is inserted into the guide cap 210, the minimum axial distance between the bottom of the groove 221 and the distal opening 212 of the guide cap 210 is fixed, when the valve prosthesis 100 is larger, the portion of the outflow tract 112 of the valve prosthesis 100 that is extruded out of the distal opening 212 of the guide cap 210 is too long, and the distal ends of the hangers 113 and the outflow tract 112 are too strongly restrained by the distal opening 212 of the guide cap 210, and are easily deformed or damaged. Such a shape and/or size loading device 200 can only be used to load a shape and/or size of valve prosthesis 100, and if one of the shapes and/or sizes of valve prosthesis 100 is slightly deviated, valve prosthesis 100 is prone to pre-compression failure. Therefore, the universality of the loading device 200 is low.
Based on this, the present invention provides a loading device for compressing an implant, which is added with a height adjusting member set on the basis of the above loading device 200. The utility model provides a loading device, under the limited condition of degree in the inner chamber of the proximal end of base insertion guide cover, through set up detachable height adjustment group in the recess on the base, and make the proximal end of valve prosthesis contact with the distal end of height adjustment group, make the axial distance between the proximal end of valve prosthesis and the distal end opening of guide cover, from the bottom of original recess and the distal end open-ended axial distance of guide cover, become the distal end of height adjustment group and the distal end open-ended axial distance of guide cover, thereby make the loading device of a shape and size can be used to compress the valve prosthesis of a shape and size when not setting up height adjustment group, can be used to compress the valve prosthesis of another kind of shape and size when setting up height adjustment group, and then improve loading device's universality.
By adjusting the height of the height adjusting piece group and arranging the height adjusted height adjusting piece group in the groove of the base, the axial distance between the far end of the height adjusting piece group and the far end opening of the guide cover can be changed along with the height change of the height adjusting piece group, and the loading device with one shape and size can be suitable for pre-compressing valve prostheses with different shapes and sizes.
The loading device according to the present invention will be described in further detail with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more fully apparent from the following description and appended claims. It should be noted that the drawings are in simplified form and are not to precise scale, and are provided for convenience and clarity in order to facilitate the description of the embodiments of the present invention.
The present embodiments provide a loading device for compressing a valve prosthesis. Referring to fig. 3, 4, 5 and 6, fig. 3 is a schematic sectional view of a loading device provided with a valve prosthesis according to an embodiment of the present invention, fig. 4 is a schematic structural view of a guide cover according to an embodiment of the present invention, fig. 5 is a schematic structural view of a base according to an embodiment of the present invention, and fig. 6 is a schematic structural view of a height adjusting member according to an embodiment of the present invention, the loading device includes a guide cover 300, a base 400 and a height adjusting member group 500.
The guide cap 300 has an inner cavity 310, a distal opening 320 and a proximal opening 330, the inner cavity 310 of the guide cap 300 is communicated with the distal opening 320 and the proximal opening 330 of the guide cap 300, and the distal opening 320 of the guide cap 300 is smaller than the proximal opening 330 of the guide cap 300.
The base 400 is provided with a groove 410, and the base 400 is used for pushing the valve prosthesis 600 to move in the inner cavity 310 of the guide cap 300 from the proximal opening 330 of the guide cap 300 to the distal opening 320 of the guide cap 300.
The height adjusting member set 500 is detachably connected to the groove 410 of the base 400, and is used for adjusting the axial distance between the bottom of the groove and the distal opening of the guide cover, i.e. the axial distance between the proximal end of the valvular prosthesis and the bottom of the groove. The axial distance M between the proximal end of the valve prosthesis and the bottom of the recess is shown in fig. 3.
In this embodiment, the loading device has a loading state in which: the distal end of the base 400 is inserted into the inner cavity 310 of the guide cover 300 through the proximal opening 330 of the guide cover 300, the portion of the valve prosthesis 600 near the distal end is crimped into the guide cover 300, the portion of the valve prosthesis 600 near the proximal end is disposed in the groove 410 of the base 400, the height adjuster group 500 is connected with the groove 410 of the base 400, and the proximal end 610 of the valve prosthesis is in contact with the distal end of the height adjuster group 500.
Since, in the loaded state, the proximal portion of the valve prosthesis 600 is disposed in the groove 410 of the base 400, the height adjustment member set 500 is connected to the groove 410 of the base 400, the proximal end 610 of the valve prosthesis is in contact with the distal end of the height adjustment member set 500, the distal end of the base 400 is inserted into the lumen 310 of the guide cap 300 through the proximal opening 330 of the guide cap 300, and the distal portion of the valve prosthesis 600 is pressed into the lumen 310 of the guide cap 300, the axial distance between the base 400 and the guide cap 300 of the valve prosthesis 600 can be changed from the axial distance between the bottom of the groove 410 and the distal opening 320 of the guide cap 300 to the axial distance between the distal end of the height adjustment member set 500 and the distal opening 320 of the guide cap 300, so that a loading device of one shape and size can be used to compress a valve prosthesis of one shape and size when the height adjustment member set 500 is not disposed, the height adjustment set 500 can be used to compress a valve prosthesis of another shape and size when provided, thereby improving the versatility of the loading device. Meanwhile, the connecting condition of the guide cover 300 and the base 400 is adjusted through the height adjusting member group 500, so that the process errors of the valve prosthesis 600, the base 400 and the guide cover 300 are offset, the valve prosthesis 600 can be compressed in a proper posture, and the compression effect of the loading tool can be improved.
Specifically, referring to fig. 3, the guide cap 300 includes a connection section 340 and a compression section 350 sequentially disposed from the proximal opening 330 to the distal opening 320 of the guide cap 300. The connecting segment 340 is used to cooperate with the base 400 for guiding the base 400 to move in the inner cavity 310 of the guiding cover 300. The compression section 350 is used for compressing the valve prosthesis 600, for example, for compressing the outflow tract of the valve prosthesis 600 and maintaining the outflow tract of the valve prosthesis 600 at a certain opening diameter, so that an operator can place the hanging loop of the valve prosthesis 600 on the fixing head in the delivery system and fix the position of the hanging loop of the valve prosthesis 600 relative to the fixing head. The connecting section 340 is a space defined by a rotating surface, a generatrix of the rotating surface is a straight line, and the compressing section 350 is preferably in a hollow cylindrical shape. The compression section 350 is a space defined by a rotating surface, a generatrix of the rotating surface is a straight line or a curve, and the compression section 350 is preferably in a hollow cone shape or a hollow gourd shape. The outer surface of the guide cap 300 may be provided with protrusions, grooves, patterns, frosted layers, etc. to increase friction between the outer surface of the guide cap 300 and an operator for easy grip.
Specifically, referring to fig. 3, the base 400 includes a shoe 430, a connecting region 440 disposed on the shoe 430, and a guide post 450 disposed on the connecting region 440, wherein the shoe 430, the connecting region 440, and the guide post 450 are disposed in order from the proximal end to the distal end of the base 400. The inner cavity 310 of the guide cap 300 may receive a guide post 450 and a connection region 440.
The bottom support 430 is cylindrical or truncated cone-shaped, and the outer surface of the bottom support can be smooth or frosted.
The connection region 440 has a cylindrical or truncated cone shape, and the outer surface thereof may be a smooth surface, a frosted surface, or the like. The base 400 is detachably coupled to the guide cover 300 by a coupling region 440. Specifically, the base 400 is engaged with the connection segment 340 of the guide cover 300 through the connection region 440, so that the connection segment 340 of the guide cover 300 can move relative to the connection region 440. In this embodiment, the connection region 440 of the base 400 is inserted into the connection section 340 of the guide cover 300 in the loaded state, and in other embodiments, the base 400 and the guide cover 300 may be connected in other manners.
The guiding column 450 may be in a shape of a funnel, a circular truncated cone, a segment of a sphere, or a crown, or may be in a shape of a combination of a plurality of the above-mentioned revolution bodies, for example, the guiding column 450 is in a shape of a combination of a circular truncated cone and a circular column.
The base 400 is provided with a groove 410, and the groove 410 is formed on the distal end surface of the connecting region 440.
The diameter ratio of the inner diameter of the groove 410 and the port of the inflow channel of the valve prosthesis 600 is 1: 1 to 2: 1, the depth of the groove 410 is 5 mm-20 mm. Wherein the inner diameter of the groove 410 refers to the diameter of the inner edge of the groove 410. In practice, the depth of the groove 410 is equal to the axial distance from the distal end surface of the connecting segment 340 to the bottom of the groove 410. In the initial stage of compressing the valve prosthesis 600, the inflow channel of the valve prosthesis 600 is disposed in the groove 410.
As an optional option, the bottom of the groove 410 is provided with at least one inward-recessed insertion hole, and the insertion hole is used for being connected with the height adjusting group, so as to prevent the height adjusting group from shaking relative to the groove 410.
Optionally, the base 400 defines an opening 460 extending through the proximal end of the base 400 to the distal end of the base 400. As such, when loading the valve prosthesis 600 into the delivery system, the inner tube may pass through the base 400 so that loading may be facilitated.
Preferably, the connection region 440 of the base 400 is slidably connected to the connection section 340 of the guide cap 300, such that the base 400 can be guided by the connection section 340 of the guide cap 300, thereby facilitating the movement of the base 400 in the guide cap 300, and facilitating the base 400 to push the valve prosthesis 600 to move in the inner cavity 310 of the guide cap 300 from the proximal opening 330 of the guide cap 300 to the distal opening 320 of the guide cap 300, thereby improving the pre-compression quality of the valve prosthesis 600.
The height adjustment member set 500 is detachably connected to the groove 410 of the base 400. In the loaded state, the height adjusting member set 500 is connected to the groove 410 of the base 400, and the proximal end 610 of the valve prosthesis is in contact with the distal end of the height adjusting member set 500, so that the proximal end 610 of the valve prosthesis is in contact with the distal end of the height adjusting member set 500, but not in contact with the groove 410 of the base 400, and thus the function of adjusting the depth of the groove 410 of the base 400 can be achieved.
Specifically, the height adjusting member set 500 includes at least one height adjusting member 510, and the height adjusting members 510 may be stacked on each other. Wherein the height adjuster 510 may not have the same shape and/or size. Different sets of height adjusters 500 may be combined by selecting different numbers, shapes, or sizes of height adjusters 510, and the height of sets 500 may vary from proximal to distal. For example, the height of the height adjusting member set 500 from the proximal end to the distal end can be varied by selecting different shapes of the height adjusting members 510, as long as the different shapes of the height adjusting members 510 can be overlapped with each other. The height-adjusting members 510 in the height-adjusting member set 500 may have the same shape, but different sizes, so long as they can be overlapped with each other and the height of the height-adjusting member set 500 from the proximal end to the distal end is changed. The height-adjusting members 510 in the height-adjusting member set 500 may have the same shape and size, as long as different numbers of height-adjusting members 510 can be stacked on top of each other and the height of the height-adjusting member set 500 varies from the proximal end to the distal end.
In this embodiment, the height adjusting members 510 have the same shape, and the height adjusting members 510 have different sizes. As shown in FIG. 6, a single height adjusting member 510 includes a body member 511 and at least one insertion member 512, and at least one insertion hole 513 formed in the body member 511. The insertion part 512 is used to be inserted into an insertion hole 513 of the other height adjusting part 510 or an insertion hole of the base 400, so that the height adjusting part 510 is connected with the other height adjusting part or the base 400. The body 511 is used to adjust the height of the height adjustment assembly 500 from the proximal end to the distal end. Wherein the axial distance between the insertion holes of the height-adjusting members 510 located at the most distal end of the height-adjusting member group 500 should be greater than the outer diameter of the proximal end 610 of the valve prosthesis, i.e., greater than the proximal outer diameter of the inflow channel of the valve prosthesis 600. When the height adjusting pieces 510 are superposed on each other to form the height adjusting piece set 500, the height of the height adjusting piece set 500 from the proximal end to the distal end is equal to the sum of the heights of the main body pieces 511 of the height adjusting pieces 510 in the height adjusting piece set 500 from the proximal end to the distal end.
The main body 511 may be cylindrical, truncated cone-shaped, etc., and the insert 512 is cylindrical or rod-shaped.
The insert 512 extends from the proximal end face of the body member 511 in a direction away from the proximal end face of the body member 511. In this embodiment, the insertion part 512 may be a rectangular parallelepiped, a round bar, a cone, or the like, and may be inserted into the insertion hole for limiting.
Preferably, the insert 512 of each height adjuster 510 is rotatably connected to the main body 511 thereof, and the main body 511 is provided with a concave structure, the concave shape and the arrangement position of the concave structure are matched with those of the insert 512, so that the insert 512 can be rotatably received in the concave structure, and thus, when the height adjuster 510 is not used, the insert 512 can be rotatably received in the concave structure, so as to save space, for example, the packaging space or the receiving space of the loading device.
Further, the height adjusting member 510 is a housing having a thickness, and the thickness of the insertion member 512 in the height adjusting member 510 is smaller than the thickness of the main body member 511. The insert 512 can be connected to the outer surface of the main body 511, or can be connected to the inner surface of the main body 511, if it is connected to the outer surface of the main body 511, the insert 512 can be inserted into the concave structure of the main body after rotating 180 ° clockwise, at this time, the concave structure is located on the outer surface of the main body, and the state that the insert 512 is inserted into the concave structure of the main body 511 can refer to fig. 7, fig. 7 is a schematic structural diagram of the height adjusting member of an embodiment of the present invention in which the insert 512 is disposed in the concave structure of the main body. If the inner surface is connected, the insertion section can be rotated 180 ° counterclockwise to be inserted into the female structure, which is located on the inner surface of the body, and the insertion member 512 is connected to the inner surface of the body member 511.
In other embodiments, the thickness of the insert 512 of the height adjuster 510 may be greater than the thickness of the body member 511.
The outer surface of the height adjusting member 510 may be a smooth surface or a frosted surface, and may be made of a transparent or non-transparent plastic material.
Preferably, the main body 511 of the height adjusting member 510 has an inner cavity, and the proximal opening of the main body 511 is communicated with the inner cavity, for example, the main body 511 may be a housing having a certain thickness, the proximal opening of the housing is communicated with the inner cavity of the housing, wherein the height adjusting member with a small size can pass through the proximal opening of the main body of the height adjusting member with a large size and be disposed in the inner cavity of the main body of the height adjusting member with a large size. Thus, when packaged, the height-adjusting members 510 of various shapes and sizes can be stacked and received by using the space in the main body 511, and the space occupied by each height-adjusting member 510 after being received is equal to the size of the height-adjusting member 510 of the maximum size.
If there are a plurality of height-adjusting members 510 in the height-adjusting member group 500, the height-adjusting members 510 located at the bottom of the height-adjusting member group 500 and used for connecting with the base 400 are numbered as the first height-adjusting members, wherein the height of the main body member from the proximal end to the distal end of the first height-adjusting member is H1The insert has a height h from the proximal end to the distal end1And the height adjusting part directly superposed with the first height adjusting part is a second height adjusting part, wherein the height of the main body part in the second height adjusting part from the near end to the far end is H2The insert has a height h from the proximal end to the distal end2By analogy, the height of the main body part in the third height adjusting part from the near end to the far end is H3The insert has a height h from the proximal end to the distal end3And so on, the height of the main body part in the Nth height adjusting part from the near end to the far end is HNThe insert has a height h from the proximal end to the distal endNThen the height of the height adjustment set 500 from the proximal end to the distal end is equal to H1+H2+H3+…+HN。
When the base 400 is provided with the guiding post 450, the main body 511 is further provided with an insertion hole 514 for the guiding post 450 to pass through. The size of the insertion hole on the first height adjusting piece is larger than or equal to the size of the guide column H1The diameter of the part above the height, the size of the insertion hole on the second height adjusting piece is more than or equal to the guiding column H1+H2The diameter of the part above the height, the size of the insertion hole on the third height adjusting piece is more than or equal to the guiding column H1+H2+H3The diameter of the part above the height, and so on, of the insertion hole in the Nth height-adjusting memberH of the size of the guide column 450 or more1+H2+H3+…+HNThe diameter of the portion above the height. For mounts 400 without guide posts or other obstructions, an insertion hole is not a necessary option.
Specifically, the number, shape and size of the insertion holes in the base 400, and the number, shape and size of the insertion holes 513 in the height-adjusting member 510 are not particularly limited. The insertion holes in the base 400 are preferably symmetrically distributed and are identical in size and shape.
When the number of the height adjusters 510 in the height adjuster group 500 is > 1, the insert of the nth height adjuster can be inserted into the insertion hole of the (N-1) th height adjuster. When the number of the height-adjusting members 510 in the height-adjusting member group 500 is one, the insert of the first height-adjusting member can be inserted into the insert hole in the base 400 and matched with the insert hole in the base 400.
If the insert 512 of the height adjusting member 510 is inserted into the corresponding insertion hole, the height of the insert inserted into the insertion hole of the other height adjusting member from the proximal end to the distal end is smaller than or equal to the height of the main body member of the other height adjusting member from the proximal end to the distal end, or the height of the insert inserted into the base 400 from the proximal end to the distal end is smaller than or equal to the height of the insertion hole of the base 400 from the proximal end to the distal end. Specifically, when the number of height-adjusting members 510 in the height-adjusting member group 500 is greater than 1, the height h of the insertion member of the Nth height-adjusting memberNLess than or equal to the height H of the main body part of the (N-1) th height adjusting partN-1Even if the insert of the nth height adjuster can be inserted into the insert hole of the (N-1) th height adjuster. When the number of the height-adjusting members 510 in the height-adjusting member group 500 is one, the height H of the insert in the first height-adjusting member1Is less than or equal to the depth H of the embedding hole in the base 4000And is fitted into an insertion hole in the base 400.
When the number of height-adjusting members 510 in the height-adjusting member group 500 is > 0, the maximum outer diameter of the Xth height-adjusting member 510 is defined as DXThen the Xth height adjustmentThe radial distance A between the maximum outer diameter of the insert of the part and the insert holeX＝[DX-D(X+1)]/2. For example, in the case of symmetrical insertion holes, the first height-adjusting member has an outer diameter D1The radial distance A between the maximum outer diameter of the insert part of the first height-adjustment part and the insert opening1＝(D1-D2)/2. Distance A of the insertion hole in the groove 410 to the circumferential edge of the inner surface of the groove 4100＝(D0-D1) A/2, wherein the inner diameter of the groove 410 is A0。
Referring to fig. 8, 9, 10 and 11, fig. 8 is a schematic structural diagram of the embodiment of the present invention in which the height adjusting member group is connected to the base, wherein the number of the height adjusting members 510 in the height adjusting member group 500 is one, fig. 9 is a schematic structural diagram of the embodiment of the present invention in which the base is connected to the guide cover, fig. 10 is a schematic structural diagram of the embodiment of the present invention in which a portion of the valve prosthesis is pressed and held in the sheath of the delivery system, fig. 11 is a schematic structural diagram of the embodiment of the present invention in which the entire valve prosthesis is pressed and held in the sheath of the delivery system, and a process of pre-compressing and loading the valve prosthesis 600 into the delivery system by the loading device in the present embodiment is as follows.
Firstly, the inflow channel of the valve prosthesis 600 is aligned and placed in the groove 410 of the base 400, the guide cover 300 is covered on the base 400, the valve prosthesis 600 slowly enters the guide cover 300 along with the matching connection of the guide cover 300 and the base 400, the distal end of the outflow channel of the valve prosthesis 600 firstly enters the compression section 350 of the guide cover 300 and then is compressed and extruded from the distal opening 320 of the guide cover 300, so as to pre-compress the valve prosthesis 600. During pre-compression, observing whether the distal ends of the hangers of the valve prosthesis 600 and the distal ends of the outflow tract are in a closed state, namely whether the hangers can be attached and whether the distal ends of the outflow tract can be attached, and putting height adjusting pieces 510 with different shapes and/or sizes into the groove 410 of the base 400 in an attempt to superpose the height adjusting pieces 510 into different height adjusting piece groups 500, and making the proximal end 610 of the valve prosthesis, namely the proximal end of the inflow tract contact with the height adjusting piece 510 at the distal end in the height adjusting piece group 500, so as to change the position of the proximal end 610 of the valve prosthesis in the groove 410 of the base 400 through the height adjusting piece group 500, and further make the distal ends of the hangers and the distal ends of the outflow tract in a closed state, so as to fix the valve prosthesis 600 to the fixing head of the conveyor.
Next, valve prosthesis 600 is secured to the fixation head in the inner tube of the delivery system.
Again, the sheath 700 in the delivery system is controlled to move, causing the valve prosthesis 600 to be gradually crimped between the sheath 700 and the inner tube until the valve prosthesis 600 is fully crimped in the sheath 700 of the delivery system. When about half of the valve prosthesis 600 enters the sheath 700, the guide cover 300 and the base 400 are separated in opposite directions, so that even if the base 400 moves in the proximal direction or the direction in which the valve prosthesis 600 flows into the channel, the guide cover 300 moves in the distal direction or the direction in which the valve prosthesis 600 flows out of the channel, and the structure of the valve prosthesis 600 partially crimped in the sheath 700 of the delivery system is schematically shown in fig. 10. Thereafter, the sheath 700 is further controlled to move, so that the valve prosthesis 600 is completely crimped by the sheath 700, and the structural diagram of the valve prosthesis 600 completely crimped in the sheath 700 of the delivery system is shown in fig. 11.
In the above embodiment, both the guide cover 300 and the base 400 of the loading device may be made of a transparent plastic material suitable for medical instruments. But other transparent or non-transparent materials may be used. Preferably, the use of a transparent material facilitates the operator's ability to view the valve stent and delivery system inside during loading.
In the above embodiments, the valve prosthesis 600 may also be other implants that need to be installed into a delivery system by pre-compression, such as vascular stents, vascular filters, etc.
Additionally, the "proximal" and "distal" in the above embodiments are relative orientations, relative positions, orientations of elements or actions with respect to each other from the perspective of a physician using the loading device, although "proximal" and "distal" are not intended to be limiting, the "proximal" generally refers to the end of the loading device that is distal from the delivery system sheath 700 during pre-compression of the stent, and the "distal" generally refers to the end that is proximal to the delivery system sheath 700. Furthermore, the term "or" in the above embodiments is generally used in the sense of comprising "and/or" unless otherwise explicitly indicated.
The above description is only for the preferred embodiment of the present invention and is not intended to limit the scope of the present invention, and any modification and modification made by those skilled in the art according to the above disclosure are all within the scope of the claims.
Claims (11)
1. A loading device for compressing an implant, comprising:
a guide cap having an inner lumen, a distal opening and a proximal opening, the inner lumen communicating with the distal opening and the proximal opening, and the distal opening being smaller than the proximal opening;
a base for urging the implant to move within the internal cavity of the guide cap from the proximal opening of the guide cap to the distal opening of the guide cap; and
the height adjusting piece group is detachably connected with the base and is used for adjusting the axial distance between the proximal end of the implant and the base.
2. The loading device according to claim 1, wherein the set of height adjustment members comprises at least one height adjustment member, the height adjustment members being stackable with one another.
3. The loading device of claim 2, wherein said height adjustment member comprises a body member and at least one insert member, said insert member being coupled to said body member, said insert member being removably coupled to said base or other height adjustment member, said body member being adapted to adjust the height of said set of height adjustment members from the proximal end to the distal end.
4. The loading device of claim 3, wherein said insert is rotatably coupled to said body member in a single said height adjustment member, said body member having a concave structure formed thereon, said concave structure having a concave shape and a position matching the shape and position of said insert, said insert being rotatably received in said concave structure.
5. The loading device of claim 3, wherein said body member has an internal cavity, and wherein said proximal opening of said body member communicates with said internal cavity.
6. The loading device of claim 3, wherein the body member has an internal cavity and the proximal opening of the body member communicates with the internal cavity, and wherein the small-sized height adjuster is insertable through the proximal opening of the body member of the large-sized height adjuster and is disposed within the internal cavity of the body member of the large-sized height adjuster.
7. The loading device of claim 1, wherein the guiding cap comprises a connecting section and a compressing section sequentially arranged from the proximal opening to the distal opening of the guiding cap, the connecting section is used for being matched with the base and guiding the base to move in the inner cavity of the guiding cap, and the compressing section is used for compressing the implant.
8. The loading device of claim 1, wherein said base is provided with a recess, said set of height adjustment members being removably connected to said recess, said set of height adjustment members being adapted to adjust the axial distance between the proximal end of said implant and the bottom of said recess.
9. The loading device of claim 8, wherein the base includes a shoe, a connection region disposed on the shoe, and a guide post disposed on the connection region, the shoe, connection region, and guide post being disposed in order from a proximal end to a distal end of the base, the proximal end of the base being inserted through the proximal opening of the guide cap and into the lumen of the guide cap in the loaded state, the guide post and the connection region being received in the lumen of the guide cap.
10. Loading device according to claim 9, wherein the recess opens onto the distal end face of the connection region.
11. The loading device according to claim 8, wherein the bottom of the groove is provided with at least one inwardly recessed insertion hole for connecting with the height adjustment group.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201920751824.0U CN210277410U (en) | 2019-05-23 | 2019-05-23 | Loading device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201920751824.0U CN210277410U (en) | 2019-05-23 | 2019-05-23 | Loading device |
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| Publication Number | Publication Date |
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| CN210277410U true CN210277410U (en) | 2020-04-10 |
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| CN201920751824.0U Active CN210277410U (en) | 2019-05-23 | 2019-05-23 | Loading device |
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| CN (1) | CN210277410U (en) |
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- 2019-05-23 CN CN201920751824.0U patent/CN210277410U/en active Active
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