CN110811927A - Implant loading device - Google Patents
Implant loading device Download PDFInfo
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- CN110811927A CN110811927A CN201810904782.XA CN201810904782A CN110811927A CN 110811927 A CN110811927 A CN 110811927A CN 201810904782 A CN201810904782 A CN 201810904782A CN 110811927 A CN110811927 A CN 110811927A
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- inner cavity
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- loading device
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- 239000007943 implant Substances 0.000 title claims abstract description 105
- 238000011068 loading method Methods 0.000 title claims abstract description 64
- 238000007906 compression Methods 0.000 claims abstract description 95
- 230000006835 compression Effects 0.000 claims abstract description 91
- 230000001154 acute effect Effects 0.000 claims abstract description 7
- 230000003068 static effect Effects 0.000 claims description 4
- 230000007704 transition Effects 0.000 description 9
- 230000003247 decreasing effect Effects 0.000 description 8
- 238000000034 method Methods 0.000 description 6
- 238000005452 bending Methods 0.000 description 5
- 230000009471 action Effects 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 230000007423 decrease Effects 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 230000000149 penetrating effect Effects 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 210000001765 aortic valve Anatomy 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 238000002788 crimping Methods 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 239000012780 transparent material Substances 0.000 description 2
- 239000000956 alloy Substances 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 210000000709 aorta Anatomy 0.000 description 1
- 230000004323 axial length Effects 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 210000005069 ears Anatomy 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000004217 heart function Effects 0.000 description 1
- 210000003709 heart valve Anatomy 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 229910001285 shape-memory alloy Inorganic materials 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a loading device of an implant, comprising: the guide cover is detachably connected with the guide seat; the guide cover is provided with a first inner cavity, the first inner cavity penetrates through the guide cover, and the diameter of at least one section of the first inner cavity is gradually reduced; the guide seat has the second inner chamber, and the second inner chamber link up the guide seat, and at least one section is the oblique straight structure that the diameter diminishes gradually in the second inner chamber, and the oblique straight structure includes a plurality of inner chamber oblique sections and the straight section of inner chamber that alternately set up in proper order, and the chamber wall of the oblique section of inner chamber is the acute angle with the axis of guide seat, and the chamber wall of the straight section of inner chamber is parallel with the axis of guide seat. The loading device can decompose the compression resistance suffered by the implant during loading, avoid the damage of the implant during loading, and particularly prevent the tip of the inflow channel of the implant from being bent to cause structural damage when being pressed and held by a loading tool; and the operation is simple, the loading efficiency is high, and the device has universality for implants with different specifications.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a loading device of an implant.
Background
Transcatheter aortic valve placement is a brand new valve replacement technology, and the principle is that a valve prosthesis is loaded into a delivery system and delivered to the root of the aorta through a catheter, and the release of a stent can ensure that the valve is fixed at the aortic valve annulus to replace the original valve with degraded function, so that the heart function of a patient is improved. The technique can treat aortic valvulopathy under the conditions of no thoracotomy and no heartbeat, and avoids the huge trauma to patients caused by the prior surgical thoracotomy and heartbeat arrest.
This technique requires the stent to be compressed to a small diameter for loading into the catheter of the delivery device. When loading the valve prosthesis with the loading tool, the guide cover is usually used to cooperate with the guide seat for preliminary compression, and then the lumen of the guide seat is used to further compress the inflow channel of the stent until the valve prosthesis is completely crimped. For the traditional loading tool, the transitional arc opening of the inlet end of the inner cavity of the guide seat is large, so that the situation that a sharp corner hits a sharp corner is easily caused, namely, an inflow channel of the support forms an obtuse angle with the inlet end of the inner cavity of the guide seat, great resistance needs to be overcome to compress the support to a great extent, the support is easily inclined, damaged or damaged due to uneven compression or local accidental bending, the operation of loading personnel is difficult, the loading efficiency is low, finally, the function of the support or the valve is defective or the service life of the support or the valve is reduced, even normal implantation work cannot be performed, and meanwhile, the operation risk can be increased due to overlong operation time. In addition, the loading tool is only suitable for a bracket with a single specification, and has the advantages of high manufacturing cost, complex structure and complex operation flow.
Therefore, a loading device which is simple in operation, high in loading efficiency, high in loading success rate and universal for supports of different specifications is urgently needed.
Disclosure of Invention
The invention aims to provide a loading device, which is used for preventing a bracket from being damaged during loading, and particularly preventing an inflow channel of the bracket from being bent when being pressed by a loading tool to cause inclination, damage or damage of the bracket.
In order to achieve the above object, the present invention provides an implant loading device comprising: the guide cover is detachably connected with the guide seat;
the guide cover is provided with a first inner cavity, the first inner cavity penetrates through the guide cover, and at least one section of the first inner cavity is gradually reduced in diameter;
the guide seat is provided with a second inner cavity, the second inner cavity penetrates through the guide seat, at least one section of the second inner cavity is an inclined straight structure with the diameter gradually reduced, the inclined straight structure comprises a plurality of inner cavity inclined sections and inner cavity straight sections which are sequentially arranged in a crossed mode, the cavity wall of each inner cavity inclined section and the axis of the guide seat form an acute angle, and the cavity wall of each inner cavity straight section is parallel to the axis of the guide seat.
Optionally, the guide cover includes an outlet portion, a compression portion, and an inlet portion.
Optionally, the first inner cavity comprises a first compression area and a second compression area which are communicated with each other, and the diameter of the inlet end of the first compression area is larger than that of the outlet end of the second compression area.
Optionally, a generatrix of the inner surface of the second compression zone is curved.
Optionally, the guiding seat comprises a guiding column, a connecting section and a base, the guiding column is arranged on the base through the connecting section,
optionally, the diameter of one end of the guide column connected with the base is larger than that of the other end.
Optionally, a groove is provided around the outer surface of the guide post inside the connecting section.
Optionally, the second inner cavity includes a third compression region and a fourth compression region that are communicated with each other, the third compression region is of the oblique-straight structure, and the diameter of the inlet end of the third compression region is larger than the diameter of the outlet end of the fourth compression region.
Optionally, the oblique-straight structure is an integrated structure of the second inner cavity or an oblique-straight component arranged in the second inner cavity.
Optionally, the guide cover is sleeved on the guide seat in a static friction connection manner or a buckling connection manner.
In the loading device of the implant provided by the invention, at least one section of the second inner cavity penetrating through the guide seat is of an inclined-straight structure with gradually reduced diameter, when an inflow channel of the implant enters the inclined-straight structure, the implant firstly enters an inner cavity inclined section with a diameter slightly smaller than the opening diameter of the inflow channel under the action of radial external force, and then sequentially enters the inner cavity straight section and the inner cavity inclined section which are arranged in a crossed manner, and the angle between the sharp corner of the inflow channel and the inner cavity straight section is almost zero, so that the implant hardly bears resistance in the movement of the inner cavity straight section, and when the implant enters the inner cavity inclined section, although each section bears resistance, the stent is small in compression degree, smooth transition can be realized, and the inclined-straight structure can be adopted, so that the resistance can be effectively decomposed, and the inclination and damage of the implant caused by uneven compression or local accidental bending can be avoided; and the oblique straight structure adopts the design that the inner diameters of a plurality of layers are gradually reduced, and is suitable for implants with different specifications.
Drawings
FIG. 1 is a schematic view of a prior art loading tool crimping a valve prosthesis;
FIG. 2 is a perspective view of a guide cover portion of the loading device of the present invention;
FIG. 3 is a side cross-sectional view of the guide cover portion of the loading unit of the present invention;
FIG. 4 is a perspective view of a guide base portion of the loading device of the present invention;
FIG. 5 is a side cross-sectional view of the guide base portion of the loading device of the present invention;
FIG. 6 is a detail view of a side cross-sectional view of the guide seat portion of the loading device of the present invention;
FIGS. 7-8 are side cross-sectional views of second compression zone T21 of the guide seat portion of the loading device of the present invention;
FIG. 9 is a schematic view of an implant according to an embodiment of the present invention;
FIGS. 10-11 are schematic views illustrating a process of loading an implant with the loading device of the present invention;
wherein 1-guide cap, 11-outlet section, 12-compression section, 13-inlet section, 2 '-guide seat, 21-guide post, 22-connecting section, 23-base, 3' -implant, 31-outflow tract, 32, 3 '2-inflow tract, 33-ear-hang, 4-delivery system, 41-inner tract, 42-stationary ear, 43-sheath, T' -compression zone, T '1-main compression zone, T2' -auxiliary compression zone, T1-first lumen, T11-first compression zone, T12-second compression zone, T2-second lumen, T21-third compression zone, T22-fourth compression zone, AA-inlet end of compression zone T ', AA-inlet end of first compression zone T11, AA' -inlet end of third compression zone T21, a1, A2, A3, A4, A5-inner cavity inclined section, outlet end of BB-compression zone T ', outlet end of BB-second compression zone T12, outlet end of BB' -fourth compression zone T22, B1, B2, B3, B4-inner cavity straight section, F-resistance and S-groove.
Detailed Description
The inventor researches and discovers that: as shown in fig. 1, when the implant 3 '(such as a valve prosthesis) is crimped by using the existing loading tool, the opening of the compression region T' of the guide holder 2 '(i.e., the lumen of the guide holder 2') is large, and a situation where a "sharp corner hits a sharp corner" is easily generated, i.e., the tip of the inflow channel 3 '2 in the implant 3' forms an obtuse angle with the arc of the lumen in the guide holder 2 ', the compression resistance F is large, and the ratio at which the inflow channel 3' 2 needs to be compressed under the interference of the resistance F is also large (D → D). Thus, the stent of the implant 3' is prone to tilt, damage or valve breakage due to uneven compression or local accidental bending.
Based on this, as shown in fig. 2-8, the present invention proposes a loading device for an implant, comprising: the guide cover 1 and the guide seat 2, the guide cover 1 is detachably connected with the guide seat 2;
the guide cover 1 is provided with a first inner cavity T1, the first inner cavity T1 penetrates through the guide cover 1, and at least one section of the first inner cavity T1 is gradually reduced in diameter;
the guide seat 2 has a second inner cavity T2, the second inner cavity T2 penetrates through the guide seat 2, and at least one section of the second inner cavity T2 is a straight-inclined structure with gradually decreasing diameter, the straight-inclined structure includes a plurality of inner cavity inclined sections a (a1, a2, A3, … …) and inner cavity straight sections B (B1, B2, B3 … …) which are sequentially arranged in a crossed manner, the cavity wall of the inner cavity inclined sections a (a1, a2, A3, … …) and the axis of the guide seat 2 form an acute angle (as shown in fig. 8, the inner cavity inclined section a2 and the axis form an acute angle α), and the cavity wall of the inner cavity straight sections B (B1, B2, B3 … …) and the axis of the guide seat 2 are parallel.
In the implant loading device of the present invention, at least one section of the second lumen T2 penetrating the guide base 2 is a straight structure having a gradually decreasing diameter, when the inflow channel of the implant enters the straight structure, the inflow channel first enters the lumen inclined section a (x) having a diameter slightly smaller than the diameter of the opening of the inflow channel under the action of the radial external force, and then sequentially enters the lumen straight section Bx and the lumen inclined section a (x +1) which are arranged in a crossing manner, and the angle between the sharp corner of the inflow channel and the lumen straight section B is almost zero, so that the movement of the implant in the lumen straight section B is hardly resisted, and when the implant enters the lumen inclined section a, although each section is resisted, the stent is compressed to a small extent, so that smooth transition can be achieved. Therefore, by adopting the inclined-straight structure, the resistance can be effectively decomposed, and the inclination, damage or valve damage of the stent of the implant body caused by uneven compression or local accidental bending can be avoided; and the oblique straight structure adopts the design that the inner diameters of a plurality of layers are gradually reduced, and is suitable for implants with different specifications. Here, the value range of x is an integer of 1 or more.
The following describes in more detail embodiments of the present invention with reference to the schematic drawings. Advantages and features of the present invention will become apparent from the following description and claims. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.
Specifically, as shown in fig. 2 to 3, the guide cap 1 has a funnel-shaped structure, and includes an outlet portion 11, a compression portion 12, and an inlet portion 13, which are connected in sequence, and the inner diameter of the compression portion 12 gradually shrinks from the direction of the inlet portion 13 to the direction of the outlet portion 11 (the diameter of the portion of the first inner cavity T1 located in the compression portion 12 gradually decreases, that is, the diameter of the first compression region T11 and the diameter of the second compression region T12 shown in fig. 3 gradually decreases); the outlet part 11 is used for the entry of the inner tube 41 of the delivery system 4 and the extension of the outflow tract 31 of the implant 3 (such as a valve stent), the inner surface of the outlet part 11 is a rotating surface, and the generatrix of the rotating surface is a straight line; the first lumen T1 is used for the first compression of the implant 3; the guide cover 1 is detachably connected to the guide base 2 through the inlet portion 13.
Alternatively, as shown in fig. 9, the implant 3 is a valve stent, which comprises an inflow canal 32, an outflow canal 31 and a hanging loop 33 connected in sequence, the implant 3 is loaded into the delivery system 4 through a loading device, delivered into the body to a target area by a catheter of the delivery system 4 in a contracted state, and then released and expanded to the state shown in fig. 9. The material for manufacturing the valve stent is not particularly limited, the material can be any one of the materials in the prior art, and optionally, the shape memory alloy material is used for manufacturing the valve stent.
Among them, the implant 3 employs a valve stent as an example to explain the invention, but the valve stent is not a limitation of the implant 3. Valve stents, such as heart valve stents, may be configured for transcatheter implantation in a body. While this embodiment illustrates one common valve stent geometry, the present invention is not limited to any particular valve stent geometry.
Specifically, as shown in fig. 3, the first inner cavity T1 includes at least a first compression region T11 and a second compression region T12 which are connected to each other, an inlet end AA of the first compression region T11 has a diameter larger than an outlet end BB of the second compression region T12, and the first compression region T11 and the second compression region T12 perform a first compression, i.e., a preliminary compression, on the implant 3 during loading. The first compression zone T11 and the second compression zone T12 are both spaces defined by the inner surface of the guiding cap 1, which is a surface of revolution whose generatrices are straight or curved, and optionally the generatrices of the inner surface of the second compression zone T12 are curved, which better maintains the opening diameter of the outflow tract 31 in the implant 3. In addition, as shown in fig. 3, the first inner cavity T1 includes other regions, which are not described in detail herein.
Alternatively, the inlet portion 13 may be divided into a connecting region and a fixed region (not shown), the connecting region having a cylindrical shape with an inner diameter equal to the diameter of the inlet end AA of the first compression region T11; the fixed area is positioned at the inlet end of the connecting area, the outer diameter of the fixed area is larger than that of the connecting area, and the inner diameter of the fixed area is equal to that of the connecting area.
As shown in fig. 4 to 8, the guide base 2 includes a guide post 21, a connecting section 22 and a base 23, the guide post 21 is disposed on the guide base 23 through the connecting section 22, the second inner cavity T2 penetrates through the guide base 2, and at least one section of the second inner cavity T2 is a straight structure with an inner diameter gradually decreasing.
As shown in fig. 4 to 5, the guide post 21 having a funnel shape is disposed on the base 23, and a diameter of one end of the guide post 21 connected to the base 23 is larger than that of the other end. Alternatively, the ratio of the height of the guide post 21 to the height of the guide cover 1 ranges from 0.6: 1-2: 1.
alternatively, the connecting section 22 of the guide holder 2 is cylindrical, and the outer surface of the connecting section 22 may be smooth, frosted, or the like. The guide cover 1 can slide along the connecting section 22 of the guide base 2 towards the base 23, and the guide cover 1 can be sleeved and fixed on the guide base 2 in a static friction connection or a snap connection manner.
Further, inside the connecting section 22, a groove S is provided around the outer surface of the guide post 21. As shown in fig. 5-6, the groove S is disposed around the outer surface of the guide post 21 and recessed inside the connecting section 22. The inner diameter of the recess S is preferably slightly larger than the diameter of the inflow channel 32. Alternatively, the ratio of the inner diameter of the recess S to the diameter of the tail portion of the implant 3 (i.e., the end portion of the implant 3 on the side of the inflow channel 32) is 1: 1-2: 1, the width of the groove S is 1-5 mm. Having the recess S accommodate the inflow channel 32 of the implant 3 when the implant 3 is compressed using the guide socket 2 can further reduce the probability of the implant 3 twisting and tilting during compression.
As shown in Figs. 5-6, a second lumen T2 extending through the entire guide housing 2 can accommodate the inner tube 41 of the delivery system 4, the second lumen T2 being used for a second compression of the implant 3, the second lumen T2 allowing a pre-compression of the inflow channel 32 of the implant 3 when the implant 3 is loaded, facilitating the loading.
For the conventional loading tool, as shown in fig. 1, the compression region T 'formed by the inner cavity of the guide seat 2' is a funnel shape with a curved generatrix, and is divided into an auxiliary compression region T '2 and a main compression region T' 1 from the inlet end aa to the outlet end bb in sequence, the diameter of the inlet end aa is the largest, and the diameter of the inlet end aa is gradually smaller from the auxiliary compression region T '2 to the main compression region T' 1. When the inflow channel 3 '2 of the implant 3' (such as a valve stent) enters the auxiliary compression region T '2 for compression, the sharp corner of the inflow channel 3' 2 first touches the point O, the direction of the inflow channel 3 '2 subjected to the force F of the inner cavity wall forms an obtuse angle with the moving direction thereof, and the inflow channel 3' 2 in the implant 3 'needs to be compressed from the diameter D to the diameter D under the interference of the force F, the compression degree is large, in this case, the inflow channel 3' 2 is easily damaged, and the loading fails.
In the present invention, the second chamber T2 includes a third compression region T21 and a fourth compression region T22 communicating with each other in the direction from the base 23 to the guide post 21, the diameter of the inlet end AA 'of the third compression region T21 is larger than the diameter of the outlet end BB' of the fourth compression region T22, the third compression region T21 is an auxiliary compression region, and the fourth compression region T22 is a main compression region.
As shown in fig. 6-8, the third compression region T21 is an inclined straight structure with a gradually decreasing diameter, the inclined straight structure includes a plurality of inner cavity inclined sections a (a1, a2, A3, … …) and inner cavity straight sections B (B1, B2, B3 … …) which are sequentially arranged in a crossing manner, the inner cavity inclined sections a (a1, a2, A3, … …) are inlet regions, the cavity walls of the inner cavity inclined sections a (a1, a2, A3, … …) are acute angles with the axis of the guide holder 2, the inner cavity inclined sections a form a circular truncated cone-shaped inner cavity, as shown in fig. 8, the inner cavity inclined sections a2 are acute angles with the axis of the guide holder 2, the inner cavity straight sections B (B1, B2, B3 … …) are transition regions, the cavity walls of the inner cavity straight sections B (B1, B2, B3 … …) are parallel with the axis of the guide holder 2, and the inner cavity inclined sections B form a cylindrical inner cavity.
When the second lumen T2 is used to compress the implant 3, as shown in fig. 7-8, first, the user applies a radial force F0 to the inflow channel 32 of the implant 3, so that the implant enters the third compression region T21, and first enters the oblique lumen segment a1 of the entry region, where the entrance diameter D of the oblique lumen segment a1 is slightly smaller than the opening diameter of the inflow channel 32, so that the force F0 to be applied is small; secondly, after the inflow channel 32 enters the inner cavity inclined section A1, the inflow channel moves to the inner cavity straight section B1, although the inflow channel 32 is subjected to resistance F, the diameter of the inflow channel 32 is transited from D to D1, the change amount is small, and smooth transition can be achieved; thirdly, after the inflow channel 32 enters the straight section B1 of the inner cavity, the angle between the sharp corner of the inflow channel 32 and the straight section B1 of the inner cavity is almost 0 degrees, so that the movement of the implant 3 at this section is hardly interfered by the guide base 2; after that, the inflow channel 32 enters the inner cavity inclined section A2 again, and similarly, although the resistance is received, the change of the diameter of the inflow channel 32 from d1 to d2 is small, and smooth transition can be achieved; finally, the inflow channel 32 reenters B2 … … until it enters the inlet end of the fourth constriction T22, the diameter of the inflow channel 32 is constricted to d, and finally the implant 3 is fully compressed into the sheath 43 of the delivery system 4.
In summary, when the inflow channel 32 of the implant 3 enters the third compression region T21, it firstly enters the inclined section Ax of the inner cavity with a diameter slightly smaller than the opening diameter of the inflow channel 32 under the action of the radial external force F0, and then enters Bx, a (x +1), B (x +1) … … in turn, when it enters the straight section B of the inner cavity, the angle between the sharp corner of the inflow channel 32 and the straight section B of the inner cavity is almost 0 °, so that the movement of the implant 3 at this section is hardly interfered by the inner cavity T of the guide seat 2; when entering the oblique segment A of the lumen, although each segment will be subject to resistance, a smooth transition is possible due to the low degree of compression of the implant. Alternatively, as shown in fig. 8, the axial lengths of the inclined inner cavity segment a and the straight inner cavity segment B are short, which facilitates smooth transition.
Optionally, the oblique-straight structure may be an integrated structure on the second inner cavity T2, and may be made into an individual oblique-straight component, which is clamped in the second inner cavity T2 of the guide seat 2 during use, the outer wall of the oblique-straight component is tightly attached to the third compression region T21, and the inner wall is provided with an inlet region inner cavity oblique section a and a transition region inner cavity straight section B. Different sizes of implant 3 may be used with different sizes of straight and angled components.
Furthermore, the inner diameter of the inlet section 13 in the guide cap 1 matches the outer diameter of the connecting section 22 in the guide base 2, so that the guide cap 1 can be detachably fitted on the guide base 2, for example, the guide cap 1 can be fitted on the guide base 2 by a static friction connection or a snap connection. As shown in fig. 10, when the guide cover 1 is fitted on the guide base 2, the inlet portion 13 of the guide cover 1 is just engaged with the connecting section 22 of the guide base 2.
The loading device according to the invention can be constructed with a guide cap 1 and a guide base 2 both made of a transparent plastic material suitable for medical instruments. Of course other transparent or non-transparent materials may be used. Preferably, the use of a loading device made of transparent material facilitates the operator to view the implant 3 and the delivery system 4 inside during the loading process.
In addition, the present invention also provides a method for loading an implant with respect to the above loading device, wherein in the following description, an end close to the operator is defined as a proximal end, and an end far from the operator is defined as a distal end. The loading method comprises the following steps:
s1, providing the implant loading device and the implant 3 to be loaded, sleeving the implant 3 outside the guide base 2, sleeving the guide cover 1 outside the implant 3, pushing the guide base 2 towards the guide cover 1, making the outflow tract 33 of the implant 3 pass through the first inner cavity T1 along the direction of gradually decreasing the diameter of the first inner cavity T1, and primarily compressing the implant 3;
s2, providing a conveying system 4, wherein the conveying system 4 comprises an inner tube 41, a fixing lug 42 arranged on the inner tube 41 and a sheath tube 43 sleeved outside the inner tube 41, withdrawing the sheath tube 43 towards the near end to expose the inner tube 41 and the fixing lug 42, passing the inner tube 41 through a second inner cavity T2 along the direction of gradually increasing the inner diameter of the inclined straight structure, and further pushing the guide seat 2 towards the guide cover 1, and at the moment, the hanging lug 33 of the implant 3 is fixed on the fixing lug 42;
s3, the sheath 43 is pushed to the far end, and the implant 3 is partially pressed into the sheath 43;
s4, separating the guide cover 1 from the guide seat 2, moving the guide cover 1 to the near end to expose the implant 3, and arranging the implant 3;
s5, adjusting the guiding seat 2 by 180 degrees, passing the inner tube 41 through the second lumen T2 of the guiding seat 2 along the direction of gradually decreasing inner diameter of the inclined straight structure, and simultaneously, advancing the sheath 43 distally, so that the implant 3 is pressed into the sheath 43;
s6, the guide seat 2 is removed, the sheath 43 is pushed forward continuously, and the implant 3 is completely pressed into the sheath 43.
Referring to fig. 10 to 11, when the loading device of the present invention is used to load the implant 3 into the delivery system 4, first, step S1 is performed: sleeving the implant 3 outside the guide seat 2, namely, placing the inflow channel 32 of the implant 3 in the groove S of the guide seat 2, sleeving the implant 3 outside the guide post 21, and sleeving the guide cover 1 outside the implant 3; the guide base 2 is then pushed toward the guide cap 1 so that the implant 3 passes through the first lumen T1 in a direction in which the diameter of the first lumen T1 gradually decreases, while the guide cap 1 is fitted over the guide base 2 to preliminarily compress the implant 3.
In the process, the outflow tract 31 of the implant 3 enters the first compression region T11 and the second compression region T12 sequentially, and after the implant 3 enters the second compression region T12, the guide post 21 of the guide seat 2 can keep the end of the outflow tract 31 at a proper compression ratio, so as to prevent the subsequent hanging lug 33 from not being well matched with the fixing lug 42 of the delivery system 4 due to the form deviation caused by over-compression of the outflow tract 31.
Next, step S2 is executed: providing delivery system 4, manipulating the handle of delivery system 4, withdrawing outer tube 43 of delivery system 4 proximally to expose retaining ears 42 on inner tube 41, and passing inner tube 41 through second lumen T2 in a direction of increasing inner diameter of the straightened configuration (i.e., in a direction of guide post 21 toward base 23); then, the guide holder 2 is pushed toward the guide cap 1, and the guide cap 1 and the guide holder 2 can be engaged or fixed, and at this time, the hanging ear 33 of the implant 3 is protruded from the exit portion 11 of the guide cap 1 and fixed to the fixing ear 42.
Optionally, as shown in fig. 11, the delivery system 4 for delivering the implant 3 includes a handle (not shown), an inner tube 41, a fixing lug 42 disposed on the inner tube 41, a sheath tube 43 sleeved outside the inner tube 41, and an outer tube (not shown) connected to the sheath tube 43, the outer tube is connected to the handle, the handle controls the outer tube to move only in the axial direction, and the outer tube can drive the sheath tube 43 to move in the axial direction; the implant 3 is fixed to the fixing lug 42 by the suspension lug 33.
Again, steps S3-S4 are performed: the handle of the delivery system 4 is operated first to advance the sheath 43 in the advancing direction of the inner tube 41 in step S2, so that the implant 3 preliminarily compressed is partially crimped into the sheath 43; subsequently, the guide cap 1 is separated from the guide holder 2, the implant 3 is exposed, and the implant 3 is arranged. The arrangement of the structure of the implant 3 (e.g. the valve leaflets of a valve stent) can reduce the structural damage to the implant 3 from subsequent crimping.
Finally, steps S5-S6 are performed: adjusting the guide base 2 by 180 degrees and operating the handle of the delivery system 4, passing the inner tube 41 through the second lumen T2 of the guide base 2 in the direction of decreasing inner diameter of the straight-angled structure (i.e. the direction from the base 23 to the guide post 21), and then, pushing the sheath 43 distally so that the implant 3 is crimped into the sheath 43; the guide base 2 is removed and the handle of the delivery system 4 is operated to advance the sheath 43 distally (i.e., in the forward direction of the inner tube 41) so that the implant 3 is completely compressed into the sheath 43.
Compared with the prior art, the loading method of the loading device is simpler and more effective.
To sum up, in the implant loading device provided in the embodiment of the present invention, at least one section of the second inner cavity penetrating through the guide seat is an oblique and straight structure with a gradually decreasing diameter, when the inflow channel of the implant enters the oblique and straight structure, the inflow channel firstly enters the inner cavity oblique section with a diameter slightly smaller than the diameter of the opening of the inflow channel under the action of the radial external force, and then sequentially enters the inner cavity straight section and the inner cavity oblique section which are arranged in a cross manner, and the angle between the sharp corner of the inflow channel and the inner cavity straight section is almost zero, so that the implant hardly suffers from resistance in the movement of the inner cavity straight section, and when the implant enters the inner cavity oblique section, although each section suffers from resistance, the stent suffers from small degree of compression, so that smooth transition can be achieved, and the oblique and straight structure can be used to effectively resolve resistance, thereby avoiding inclination and structural damage of the implant due to uneven compression or local accidental bending; the oblique-straight structure adopts the design that the inner diameters of a plurality of layers are gradually reduced, and is suitable for implants with different specifications; the loading device is relatively simple to operate and high in loading efficiency.
The above description is only a preferred embodiment of the present invention, and does not limit the present invention in any way. It will be understood by those skilled in the art that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.
Claims (10)
1. An implant loading device, comprising: the guide cover is detachably connected with the guide seat;
the guide cover is provided with a first inner cavity, the first inner cavity penetrates through the guide cover, and at least one section of the first inner cavity is gradually reduced in diameter;
the guide seat is provided with a second inner cavity, the second inner cavity penetrates through the guide seat, at least one section of the second inner cavity is an inclined straight structure with the diameter gradually reduced, the inclined straight structure comprises a plurality of inner cavity inclined sections and inner cavity straight sections which are sequentially arranged in a crossed mode, the cavity wall of each inner cavity inclined section and the axis of the guide seat form an acute angle, and the cavity wall of each inner cavity straight section is parallel to the axis of the guide seat.
2. The implant loading device of claim 1, wherein said guiding cap comprises an outlet portion, a compression portion and an inlet portion.
3. The implant loading device of claim 1, wherein said first lumen comprises a first compression zone and a second compression zone in communication with each other, said first compression zone having an inlet end diameter greater than an outlet end diameter of said second compression zone.
4. The implant loading device of claim 3, wherein a generatrix of the inner surface of said second compression zone is curvilinear.
5. The implant loading device according to claim 1, wherein said guide base comprises a guide post, a connecting section and a base, said guide post being disposed on said base through said connecting section.
6. The implant loading device of claim 5, wherein the diameter of the end of said guide post connected to said base is greater than the diameter of the other end.
7. Implant loading device according to claim 5, characterised in that inside the connecting section a groove is provided around the outer surface of the guiding post.
8. The implant loading device of claim 1 or 3, wherein said second lumen comprises a third compression zone and a fourth compression zone in communication with each other, said third compression zone being in said straightened configuration, said third compression zone having an inlet end diameter greater than an outlet end diameter of said fourth compression zone.
9. The implant loading device of claim 8, wherein said strait-straight structure is an integral structure of said second lumen or a strait-straight component disposed in said second lumen.
10. The implant loading device according to claim 1, wherein said guiding cap is fitted over said guiding seat by means of a static friction connection or a snap connection.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810904782.XA CN110811927A (en) | 2018-08-09 | 2018-08-09 | Implant loading device |
| PCT/CN2019/099518 WO2020029979A1 (en) | 2018-08-09 | 2019-08-06 | Implant loading apparatus |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810904782.XA CN110811927A (en) | 2018-08-09 | 2018-08-09 | Implant loading device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN110811927A true CN110811927A (en) | 2020-02-21 |
Family
ID=69414555
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810904782.XA Withdrawn CN110811927A (en) | 2018-08-09 | 2018-08-09 | Implant loading device |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN110811927A (en) |
| WO (1) | WO2020029979A1 (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112315636A (en) * | 2020-11-27 | 2021-02-05 | 南京浩衍鼎业科技技术有限公司 | Pressing and holding device system for intracranial degradable stent |
| CN113796972A (en) * | 2020-06-15 | 2021-12-17 | 西门子医疗有限公司 | Threading aid for threading objects into a guide device |
| WO2022048349A1 (en) * | 2020-09-02 | 2022-03-10 | 上海微创心通医疗科技有限公司 | Implant loading tool and medical device |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20080114444A1 (en) * | 2006-11-09 | 2008-05-15 | Chun Ho Yu | Modular stent graft and delivery system |
| US9561102B2 (en) * | 2010-06-02 | 2017-02-07 | Medtronic, Inc. | Transcatheter delivery system and method with controlled expansion and contraction of prosthetic heart valve |
| US20140364942A1 (en) * | 2011-09-30 | 2014-12-11 | Jenavalve Technology Gmbh | System and method for loading a stent into a medical delivery system |
| US9345573B2 (en) * | 2012-05-30 | 2016-05-24 | Neovasc Tiara Inc. | Methods and apparatus for loading a prosthesis onto a delivery system |
| CN106361467B (en) * | 2015-07-24 | 2019-05-31 | 上海微创心通医疗科技有限公司 | The loading attachment of implant |
| CN209136986U (en) * | 2018-08-09 | 2019-07-23 | 上海微创心通医疗科技有限公司 | The loading attachment of implant |
-
2018
- 2018-08-09 CN CN201810904782.XA patent/CN110811927A/en not_active Withdrawn
-
2019
- 2019-08-06 WO PCT/CN2019/099518 patent/WO2020029979A1/en active Application Filing
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113796972A (en) * | 2020-06-15 | 2021-12-17 | 西门子医疗有限公司 | Threading aid for threading objects into a guide device |
| WO2022048349A1 (en) * | 2020-09-02 | 2022-03-10 | 上海微创心通医疗科技有限公司 | Implant loading tool and medical device |
| CN112315636A (en) * | 2020-11-27 | 2021-02-05 | 南京浩衍鼎业科技技术有限公司 | Pressing and holding device system for intracranial degradable stent |
| CN112315636B (en) * | 2020-11-27 | 2022-06-03 | 南京浩衍鼎业科技技术有限公司 | Pressing and holding device system for intracranial degradable stent |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2020029979A1 (en) | 2020-02-13 |
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Application publication date: 20200221 |