CN211460682U - Embolism collection device and embolism protection system - Google Patents
Embolism collection device and embolism protection system Download PDFInfo
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- CN211460682U CN211460682U CN201922366087.5U CN201922366087U CN211460682U CN 211460682 U CN211460682 U CN 211460682U CN 201922366087 U CN201922366087 U CN 201922366087U CN 211460682 U CN211460682 U CN 211460682U
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Abstract
The utility model relates to an embolus collecting device, an embolus protecting system and an embolus collecting method, wherein the embolus collecting device comprises a near-end connecting piece; the first supporting element comprises a plurality of supporting rods arranged around an axis, at least part of the supporting rods are bent to form a concave surface facing the axis, each supporting rod is provided with a first near end and a first far end, and the first near ends are arranged on the near end connecting pieces after being folded; a first filter element is disposed on the first support element and has a second proximal end disposed on the first proximal end and a second distal end forming an opening. The utility model has the advantages of, effectively avoid the embolism to get into cerebral blood vessel and downstream blood vessel to do not cause the interference to surgical instruments business turn over blood vessel.
Description
Technical Field
The utility model relates to the technical field of medical equipment, concretely relates to embolus collection device and embolism protection system.
Background
In cardiac surgery, cardiopulmonary bypass, catheter-based interventional cardiology, ascending aorta, and other procedures involving the heart and aorta, the surgical instruments are operated to produce platelet polymers (e.g., emboli, lipid droplets, bacterial clots, tumor cells or other small pieces of tissue) or atherosclerotic debris and debris dislodged from the wall of the artery during the procedure is carried with the blood stream into the cerebral blood circulation and other important systemic arterial systems as embolic material. Embolic material entering the cerebral blood circulation can occlude small arteries, resulting in local cerebral vascular embolism (causing a stroke) which has become a common complication of cardiac and aortic surgery. The substances entering the downstream blood circulation and causing embolism of the downstream organs can further cause the organ function to decline and even cause organ failure.
During surgery, the formation of embolic material is prevented by placing an embolic protection system within the aorta to divert, capture or collect plaque, debris or emboli of the anterior flow, to avoid the embolic material from entering the cerebral blood circulation and downstream blood circulation.
The embolic protection system in the prior art has the problems of complex design and large volume, and can cause the phenomenon of kinking of different surgical instruments in the surgical process, thereby being not beneficial to surgical operation.
SUMMERY OF THE UTILITY MODEL
An object of the utility model is to provide an embolus collection device and embolism protection system to the interception embolism for the embolism material can not get into cerebral vessels and low reaches blood vessel, and this embolus collection device can not cause the interference to surgical instruments basically.
In order to achieve the above object, the present invention provides a plug collecting device, including:
a proximal connector;
the first supporting element comprises a plurality of supporting rods which are arranged around an axis at intervals, at least part of the supporting rods are bent to form a concave surface facing the axis, each supporting rod is provided with a first near end and a first far end which are opposite along the direction parallel to the axis, and the first near end of each supporting rod is arranged on the near end connecting piece after being folded; and the number of the first and second groups,
a first filter element having a second proximal end and a second distal end opposite to each other, the first filter element being disposed on the first support element, the second proximal end being disposed on the first proximal end of the support rod, the second distal end being disposed on the first support element and forming an opening.
Optionally, a recess is provided on the embolus collecting device for forming a channel between the embolus collecting device and the inner wall of the blood vessel, the channel running through along the axis.
Optionally, the plurality of support rods includes at least one first support rod, and when the number of the first support rods is two or more, the two or more first support rods are arranged adjacently; each of the first support rods has a local recessed structure with a convex side facing the axis, and the first filter element is attached to the local recessed structure of the first support rod to form the recess.
Optionally, the first filter element is attached to a surface of two adjacent support bars with a local recess structure between the two adjacent support bars, a convex side of the local recess structure facing the axis to form the recess.
Optionally, the first filter element is attached to a surface of two adjacent support rods, the recess being formed between the two adjacent support rods when the first filter element is subjected to a force directed towards the axis.
Optionally, the plurality of support rods include two adjacent second support rods, and a gap between two adjacent second support rods is larger than a gap between the other two adjacent support rods; when the first filter element is subjected to a force directed towards the axis, the recess is formed between the two adjacent second support rods.
Optionally, the embolus collecting device further comprises a distal end connecting piece, and the first distal end of each support rod is arranged on the distal end connecting piece after being folded.
Optionally, the first support element has a first position, the first support element is configured to abut against the inner wall of the blood vessel in the deployed state, and the second distal end of the first filter element is disposed at the first position along the circumference of the first support element, or the second distal end of the first filter element is disposed between the first position and the first distal end along the circumference of the first support element.
Optionally, the distance from the first position to the first proximal end is not equal to the distance from the first position to the first distal end in a direction parallel to the axis.
Optionally, the distance from the first location to the first proximal end and the distance from the first location to the first distal end are the same in a direction parallel to the axis.
Optionally, the plurality of support rods are arranged at unequal intervals around the axis in a plane perpendicular to the axis.
Optionally, the first support element has a length, in a direction parallel to the axis, of 20mm to 60 mm; the first support element has a maximum length in a direction perpendicular to the axis of 20mm to 40 mm.
To achieve the above object, the present invention further provides a plug protection system, comprising a conveying device, a plug deflecting device and a plug collecting device as described in any one of the previous items;
the delivery device has opposite fourth proximal and distal ends;
said embolus deflecting means is connected to said delivery means and comprises a second filtering element;
the embolus collecting device is connected to the delivery device and is located between the embolus deflecting device and the fourth proximal end.
Optionally, the delivery device comprises a first delivery tube and an outer sheath tube, the embolus deflecting device and the embolus collecting device are respectively connected with the first delivery tube, and the outer sheath tube is provided with a first inner cavity which is axially communicated and is used for accommodating the embolus deflecting device, the embolus collecting device and the first delivery tube.
Optionally, the embolus deflecting device has third distal and proximal ends opposite, the first delivery tube being connected to the third distal and/or proximal ends.
Optionally, the delivery device comprises an outer sheath tube having a first lumen extending axially therethrough, a first delivery tube having a second lumen extending axially therethrough, and a second delivery tube;
the embolus collecting device is connected with the first delivery tube, the embolus deflecting device is connected with the second delivery tube, the second inner cavity is used for accommodating the embolus deflecting device and the second delivery tube, and the first inner cavity is used for accommodating the embolus collecting device and the first delivery tube.
Optionally, the embolus deflecting device has third distal and proximal ends opposite to each other, the second duct connecting the third distal and/or proximal ends.
Optionally, the proximal end connector of the embolus collecting device is provided with a first through hole penetrating along a direction parallel to the axis, and the embolus collecting device is sleeved on the first conveying pipe through the first through hole and is fixedly connected with the first conveying pipe.
Optionally, the embolus collecting device further comprises a distal end connecting piece, the first distal end of the supporting rod is arranged on the distal end connecting piece after being folded, the distal end connecting piece is provided with a second through hole penetrating along a direction parallel to the axis, and the distal end connecting piece is sleeved on the first conveying pipe through the second through hole and can slide on the first conveying pipe along the axial direction of the first conveying pipe.
Optionally, the embolus collecting device further comprises a distal end connector, the first distal end of the support rod is arranged on the distal end connector; the embolus collecting device is characterized in that the near-end connecting piece is provided with a first through hole which penetrates in a direction parallel to the axis, the far-end connecting piece is provided with a second through hole which penetrates in a direction parallel to the axis, the embolus collecting device is sleeved on the first conveying pipe through the first through hole and the second through hole, the first conveying pipe is further provided with a limiting bulge, and the limiting bulge is located between the near-end connecting piece and the far-end connecting piece and used for limiting the embolus collecting device to be separated from the first conveying pipe.
Compared with the prior art, the utility model discloses an embolus collection device and embolism protection system have following advantage:
the embolic protection system comprises an embolic collection device comprising a proximal connector, a first support element, and a first filter element; the first supporting element comprises a plurality of supporting rods which are arranged around an axis at intervals, each supporting rod is bent to form a concave surface facing the axis, at least part of the supporting rods are provided with a first near end and a first far end which are opposite along the direction parallel to the axis, and the first near end of each supporting rod is arranged on the near end connecting piece after being folded; the first filter element has a second proximal end and a second distal end opposite to each other, the filter element is disposed on the support element, the second proximal end is disposed on the first proximal end of the support rod, and the second distal end is disposed on the support element to form an opening. In transcatheter procedures, the embolic collecting device is used in conjunction with an embolic deflecting device for intercepting embolic material in the blood to prevent the embolic material from entering the cerebral and downstream blood vessels.
The embolus collecting device can be provided with a concave part which is used for forming a channel between the embolus collecting device and the inner wall of the blood vessel for the instrument conveying pipe to pass through, so that the embolus collecting device does not cause interference to the surgical instrument.
Drawings
Fig. 1a is a schematic structural view of an embolus collecting device provided by the present invention according to a first embodiment;
3 FIG. 3 1 3 b 3 is 3 a 3 cross 3- 3 sectional 3 view 3 A 3- 3 A 3 of 3 the 3 embolic 3 collecting 3 device 3 of 3 FIG. 3 1 3 a 3, 3 without 3 the 3 proximal 3 connector 3 shown 3 and 3 with 3 the 3 support 3 rod 3 shown 3 in 3 cross 3- 3 section 3 only 3; 3
FIG. 2 is a partial cross-sectional view of a human aorta, with arrows indicating the direction of blood flow;
FIG. 3 is a schematic view of the present invention positioning the embolic collecting device of FIG. 1 in the ascending aorta;
FIG. 4 is a schematic view of the embolic collecting device of FIG. 1 positioned in the ascending aorta of the present invention, illustrating the position of the surgical instrument in relation to the embolic collecting device;
FIG. 5 is a schematic view of the embolic collecting device of FIG. 1 positioned in the descending aorta of the present invention, shown in use with an embolic deflection device;
FIG. 6 is a schematic view of a variation of the embolic collecting device of FIG. 1, showing the filtering element and the attachment location not at the midpoint of the support rod;
FIG. 7 is a schematic view of another variation of the embolic collecting device of FIG. 1, not shown with filter elements, and with support rods arranged at unequal intervals along the circumference of the embolic collecting device;
fig. 8a is a schematic structural view of an embolic collecting device according to a second embodiment of the present invention, wherein the filter element is not shown;
FIG. 8b is a cross-sectional view of the embolic collecting device of FIG. 8 a;
fig. 9 is a schematic structural view of an embolic collecting device according to a third embodiment of the present invention, showing no filter element;
FIG. 10 is a schematic illustration of an embolic protection system according to an embodiment, without an embolic deflection device;
FIG. 11a is a schematic view of the embolic protection system of FIG. 10 showing a first connection of the embolic collection device to the first delivery tube, without the filter element shown;
FIG. 11b is a schematic view of a second connection of the embolic collection device to the first delivery tube of the embolic protection system of FIG. 10, without the filter element shown.
[ reference numerals are described below ]:
100-an embolus collection device;
110-a proximal connector;
120-a first support element;
121-bar, 121 a-third bar, 121 b-fourth bar, 121 c-fifth bar, 121 d-first bar, 121 e-second bar, 122-recess;
130-a first filter element;
140-a distal connector;
210-aortic arch, 220-ascending aorta, 230-descending aorta, 240-innominate artery, 250-left common carotid artery, 260-left subclavian artery;
300-embolism;
400-embolus deflecting means;
500-an instrument delivery tube;
600-a first delivery tube;
610-a limit protrusion;
700-sheath tube;
800-guiding the guide wire.
Detailed Description
To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings. 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.
As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural forms "a plurality" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art. The same or similar reference numbers in the drawings identify the same or similar elements.
Herein, the terms "proximal" and "distal" are relative positions, relative orientations of elements with respect to each other from the perspective of a clinician using a medical device, and although "proximal" and "distal" are not intended to be limiting, the term "distal" generally refers to the end of the medical device that is first introduced into a patient, and the term "proximal" generally refers to the end of the medical device that is closer to the clinician during normal operation.
It is an object of the present invention to provide an embolus collecting device for placement in the aorta prior to or during transcatheter procedures (procedures involving the heart, aorta, such as cardiac surgery, cardiopulmonary bypass, catheter-based interventional cardiology, ascending aorta, etc.) that may produce emboli, to filter, intercept emboli in the blood, avoiding emboli from entering the cerebral and downstream vessels and causing complications.
Fig. 1 shows an embolic collecting device 100 according to a first embodiment of the present invention, said embolic collecting device 100 comprising a proximal connector 110, a first support element 120, a first filter element 130 and a distal connector 140. The first support element 120 is used for supporting the first filter element 130, so that the first filter element 130 can partially fit with the inner wall of the blood vessel to intercept embolic materials.
With continued reference to fig. 1, the first supporting element 120 includes a plurality of supporting rods 121 disposed at intervals around an axis, at least a portion of the supporting rods 121 are bent to form a concave surface facing the axis, each of the supporting rods 121 has a first proximal end and a first distal end opposite to each other along a direction parallel to the axis, the first proximal end of each of the supporting rods 121 is disposed on the proximal connecting member 110 after being folded, and the first distal end of each of the supporting rods 121 is disposed on the distal connecting member 140 after being folded. That is, from the first proximal end to the first distal end, the distance from the support rod 121 to the axis increases and then decreases, so that the first support element 120 forms a structure with a middle portion expanded and two ends tapered.
The first filter element 130 is a filter net with an umbrella structure and has a second proximal end and a second distal end opposite to each other, the first filter element 130 is disposed on the first support element 120, the second proximal end is disposed on the first proximal end of the support rod 121 (equivalent to the second proximal end of the first filter element 130 is disposed on the proximal end connector 110), the second distal end is disposed on the first support element 120 to form an opening, and the opening is used for allowing a plug to enter the first filter element 130 when the plug is captured.
It is understood that the axis is the axis of the embolus collecting device 100 in this embodiment, and the axial direction mentioned below is the direction parallel to the axis, the circumferential direction is the direction surrounding the axis, and the radial direction is the direction perpendicular to the axis.
When the embolic collection device 100 is placed in a blood vessel, the second distal end of the first filter element 130 will serve as the inflow end of the embolic collection device 100, while the second proximal end of the first filter element 130 serves as the outflow end of the embolic collection device 100.
Referring to fig. 2, fig. 2 shows a partial cross-sectional view of a human aorta and primarily shows a portion of an aortic arch 210 that is arcuately curved above the aorta. Taking the orientation shown in fig. 2 as an example, the left part of the aortic arch 210 is the ascending aorta 220, the right part of the aortic arch 210 is the descending aorta 230, the convex side of the aortic arch 210 emits three collateral blood vessels, and the three collateral blood vessels are the innominate artery 240 (i.e. the brachiocephalic artery), the left common carotid artery 250 and the left subclavian artery 260 in sequence from right to left. The blood flow with the embolic material 300 flows from the ascending aorta 220 through the aortic arch 210 to the descending aorta 230, and then continues to flow into the downstream blood vessels, while the blood flow enters the innominate artery 240, the left common carotid artery 250, and the left subclavian artery 260 at the aortic arch 210 and then flows into the cerebral vessels.
The embolus collecting device 100 can be placed at different positions of the aorta depending on the situation. Referring to fig. 3 and 4, in some embodiments, the embolic collecting device 100 is positioned in the ascending aorta 220, blood with entrained embolic material 300 flows from the inflow end to the embolic collecting device 100, and after the first filter element 130 intercepts the embolic material 300, the blood flows from the outflow end out of the embolic collecting device 100, such that the embolic material 300 is intercepted and captured by the embolic collecting device 100 before entering the aortic arch 210. So that embolic material 300 does not enter the innominate artery 240, the left common carotid artery 250, the left subclavian artery 260, and the descending aorta 230. Alternatively, referring to fig. 5, in other embodiments, the embolic collecting device 100 is used in conjunction with an embolic deflecting device 400, wherein the embolic deflecting device 400 is positioned at the aortic arch 210 to cover the entrances of the innominate artery 240, the left common carotid artery 250, and the left subclavian artery 260 such that embolic material 300 is diverted at the aortic arch 210 into the descending aorta 230, at which time the embolic collecting device 100 is positioned at the descending aorta 230 and blood is filtered to intercept the embolic material 300 for the purpose of protecting the cerebral and downstream blood vessels simultaneously.
Further, the emboli collecting device 100 is also visualized to facilitate accurate positioning of the emboli collecting device 100 into the ascending aorta 220 or the descending aorta 230. In this embodiment, the first support element 120 or the first filter element 130 may be made of a material having developability, or a developing element may be provided on the first support element 120 or the first filter element 130.
As shown in fig. 4, before or during the transcatheter procedure, the embolus collecting device 100 is delivered into the blood vessel along the femoral artery, and the surgical instrument is delivered to the surgical site through the femoral artery and through the embolus collecting device 100 by the instrument delivery tube 500, and the embolus substance 300 generated during the surgical operation using the surgical instrument is captured as the blood flow flows toward the embolus collecting device 100. Meanwhile, during the operation, it is preferable that the embolus collecting device 100 does not interfere with the instrument delivery tube 500, and for this purpose, a recess (shown in fig. 4) may be provided on the embolus collecting device 100, and the recess is configured to form a passage penetrating along the axis between the embolus collecting device 100 and the inner wall of the blood vessel.
In this embodiment, the first supporting element 120 is mainly composed of a plurality of supporting rods 121, the supporting rods 121 are distributed radially, and the supporting rods 121 are not connected to each other, that is, there is no circumferential connection, so that the first filtering element 130 is attached to the surfaces of two adjacent supporting rods 121, and there may be a local concave structure between the two supporting rods 121, the local concave structure facing the axis to form the concave portion. Or the first filter element 130 is attached to the surface of two adjacent support bars 121, and when the second filter element 130 is subjected to a force directed to the axis, the recess is formed between the two adjacent support bars 121. In some embodiments, the plurality of support bars 121 may include two adjacent second support bars, and a gap between two adjacent second support bars is greater than a gap between the other two adjacent support bars 121; when the first filter element 130 is subjected to a force directed toward the axis, the recess is formed between the adjacent two of the second support rods. In particular, when the embolus collecting device 100 is positioned in a blood vessel, if the density of the supporting rods 121 is high (i.e. the gap between two adjacent supporting rods is small), the instrument conveying pipe 500 can also press two adjacent supporting rods 121 to increase the gap between two adjacent supporting rods 121, and thus increase the concave part to allow the instrument conveying pipe 500 to pass through. That is, the first support element 120 does not interfere with the passing of the surgical instrument into and out of the blood vessel, thereby making the passing of the surgical instrument difficult or even impossible.
The number of the supporting rods 121 can be 4-25, and it is further preferable that the number of the supporting rods 121 is 12-18. All the support bars 121 may have the same width, or at least some of the support bars 121 may have different widths (as shown in fig. 1 b). If the widths of at least some of the supporting bars 121 are not equal, the width ratio between the supporting bar 121 with the largest width and the supporting bar 121 with the smallest width may be 1.2-2. The support rods 121 with different widths jointly form the first support element 120, and the support rods 121 with different widths can generate different support forces when the embolus collecting device 100 is placed in a blood vessel, so that the instrument conveying pipe 500 can pass through the embolus collecting device 100. It is understood that the "width" refers to a dimension of the support bar 121 in the circumferential direction of the first support member 120.
Specifically, as shown in fig. 4, according to the anatomical structure of the blood vessel, the instrument-conveying tube 500 is usually moved along the upper wall of the aorta and enters the aorta, and when the support bar 121 having a smaller width is disposed near the upper wall of the aorta and the support bar 121 having a larger width is disposed near the lower wall of the aorta, the support bar 121 having a smaller width generates a smaller supporting force, so that when the support bar 121 is pressed by the instrument-conveying tube 500, the support bar 121 having a smaller width is more easily deformed to enlarge the recess, and allow the instrument-conveying tube 500 to pass through. It is understood that the terms "upper wall" and "lower wall" are defined according to the relative positions of the inner walls of the aortic vessels in the orientation shown in fig. 4, wherein the inner wall of the vessel above the aortic arch 210 and the inner wall of the vessel on the left side in the ascending aorta 220 and the inner wall of the vessel on the right side in the descending aorta 230 are defined as "upper walls", and the inner wall of the vessel below the aortic arch 210 and the inner wall of the vessel on the right side in the ascending aorta 220 and the inner wall of the vessel on the left side in the descending aorta 230 are defined as "lower walls".
Referring to fig. 3, 4 and 5, the first support element 120 has a first position where the radial dimension of the embolic collection device 100 is greatest and conforms to the inner wall of the blood vessel when the embolic collection device 100 is placed in the blood vessel. That is, in the first position, the first support element 120 has a first cross-section that is perpendicular to the axis (i.e., the first cross-section is a radial cross-section) and has a maximum area compared to other radial cross-sections of the first support element 120. In the present embodiment, the maximum length of the first support element 120 in the radial direction is 20mm to 40mm (i.e. the maximum distance between two points on the first cross section is 20mm to 40 mm). For example, when the radial cross-section of the first support element 120 is circular, the diameter of the first support element 120 at the first position may be 20mm to 40mm, preferably 25mm to 35mm, depending on the inner diameter of the blood vessel, and is selected as desired. In addition, the length of the first support element 120 may be 20mm to 60mm, preferably 35mm to 50 mm. The term "length" as used herein refers to the dimension of first support element 120 in the axial direction of embolic collection device 100.
In this embodiment, the first support element 120 may have different shapes, such as a sphere, a football, a double pointed shape, etc. The distance from the first location to the first proximal end may be equal to the distance from the first location to the first distal end (i.e., the first location is located in the middle of the first support element 120, as shown in fig. 1 a), or may be unequal (the first location is not located in the middle of the first support element 120, as shown in fig. 6). When the first position is not in the middle of the first support element 120, the distance from the first position to the first distal end is less than the distance from the first position to the first proximal end, or the distance from the first position to the first distal end is greater than the distance from the first position to the first proximal end.
Preferably, the second distal end of the first filter element 130 is disposed at the first position along the circumference of the first support element 120, so that the second distal end of the first filter element 130 can be attached to the inner wall of the blood vessel, so that the first filter element 130 can capture the embolic material 300 to the maximum extent and prevent the embolic material 300 from being caught between the embolic collection device 100 and the inner wall of the blood vessel. Alternatively, the second distal end of the first filter element 130 is disposed between the first position and the first distal end of the support rod 121 along the circumferential direction of the first support element 120.
Alternatively, the plurality of support rods 121 may be uniformly arranged around the axis or non-uniformly arranged around the axis, as shown in fig. 7. Referring to fig. 7, the three support bars 121 of the first support element 120 of the embolus collecting device 100 shown in fig. 7 are a third support bar 121a, a fourth support bar 121b and a fifth support bar 121c, wherein the interval between the third support bar 121a and the fourth support bar 121b is W1The interval between the fourth supporting rod 121b and the fifth supporting rod 121c is W2Preferably W2Is not equal to W1. This also has the advantage of forming the depression to facilitate passage of the instrument tube 500 through the embolus collecting device 100, particularly when the embolus collecting device 100 is positioned in the descending aorta 230, the instrument tube 500 travels along the upper wall of the descending aorta 230 so that two of the more spaced support bars 121 are positioned at the upper wall of the descending aorta 230 (e.g., when W is2<W1The third and fourth support bars 121a and 121b are closer to the upper wall), the device conveying pipe 500 can pass through more easily, and the area of the first filter element 130 arranged between the two support bars 121 with larger interval can be relatively larger, so that the device conveying pipe 500 can be better covered to prevent the embolism from side leakage.
Typically, the embolic collection device 100 is compressed in a delivery device and delivered to a predetermined location in a blood vessel by the delivery device, and thus the first support element 120 can be made of a material having elasticity. In some embodiments, the first support element 120 is laser cut from a tube or sheet, while in other embodiments, the first support element 120 may be woven from filaments, which may be monofilaments or may be wound from multiple filaments.
At least a portion of the support rods 121 of the first support element 120 may be connected to the first filter element 130 by gluing, welding, heat pressing, sewing, laser processing, etc. The first filter element 130 is made of materials having biocompatibility, such as nickel-titanium alloy, high polymer materials, inorganic non-metals, and the like. These biocompatible materials may be pre-processed into a film material and then perforated to form the first filter element 130, or processed into wire materials and then woven into a mesh structure to form the first filter element 130. Depending on the material, the first filter element 130 may or may not have elasticity. The filtering holes formed in the first filtering element 130 may be circular or have other shapes, and when the filtering holes are circular, the diameter of the filtering holes may be 30um to 250um, preferably 100um to 200um, and the sum of the areas of all the filtering holes accounts for 40% to 70% of the area of the whole first filtering element 130. In addition, the first filter element 130 may be formed by a single layer of filter screen, or may be formed by stacking multiple layers of filter screens, and the aperture of the filter holes on each layer of filter screen may be the same or different.
Further, at least one surface of the first filter element 130, for example, the surface facing the inflow end, is provided with a coating (not shown), which is a heparin coating or an anti-coagulant coating, so as to prevent plugs from accumulating on the first filter element 130 and causing blockage of the first filter element 130. The coating may be formed by a process such as spraying or dipping.
Fig. 8a and 8b are schematic structural views of an embolus collecting device 100 according to a second embodiment of the present invention. This embodiment is different from the first embodiment in the manner of forming the recess. Specifically, the first supporting element 120 includes at least one first supporting rod 121d and several second supporting rods 121e, wherein when the number of the first supporting rods 121d is two or more, the two or more first supporting rods 121d are adjacently arranged. Each of the first support rods 121d has a partially recessed structure with a convex side disposed toward the axis, and the first filter element 130 is attached to the partially recessed structure of the first support tube 121d to form the recess 122. Likewise, when the embolic collecting device 100 is placed in a blood vessel, the recess 122 is positioned towards the upper wall of the blood vessel, such that an instrument channel is formed between the recess 122 and the upper wall of the blood vessel for passage of an instrument delivery tube 500. This design is particularly suitable for the first support element 120 with a larger number of support bars 121 (e.g., when one first support element 120 includes more than 15 support bars 121).
In this embodiment, the second support rods 12e may be arranged on the same circular arc at the first position, and the diameter of the circular arc may be set with reference to the diameter of the first support element 120 in the first embodiment, as long as the first support element 120 can support the first filter element 130 in the blood vessel and make the first filter element 130 partially fit the inner wall of the blood vessel to intercept the embolic material 300.
Fig. 9 shows a schematic structural diagram of an embolus collecting device 100 provided by a third embodiment of the present invention. In this embodiment, the embolic collection device 100 does not include a distal connector. In detail, the supporting rod 121 is a rod-shaped structure, which may be a curved rod-shaped structure or a straight rod-shaped structure, and the distance from the supporting rod 121 to the axis gradually increases from the first proximal end to the first distal end. In other words, in the present embodiment, when the cross section of the first supporting element 120 perpendicular to the axis is circular, the diameter of the first supporting element 120 is the largest at the first distal end of the supporting rod 121, so the first position is located at the first distal end, and the second distal end of the first filtering element 130 is also connected with the first distal end of the supporting rod 121. It is understood that the first distal end may be an end of the supporting rod 121, or may have a certain length (in this case, the first distal end is a straight rod structure).
It is a further object of embodiments of the present invention to provide an embolic protection system for implantation in the aorta for collecting emboli prior to or during a procedure that may produce emboli, such as Transcatheter Mitral Valve Replacement (TMVR), left atrial appendage occlusion, etc. Referring to fig. 5, the embolic protection system comprises a delivery device, an emboli deflecting device 400 and an emboli collecting device 100 provided as provided in any of the previous embodiments. The delivery device has opposing fourth proximal and distal ends. The embolus deflecting device 400 is connected to the delivery device and comprises a second support element and a second filter element disposed on the second support element. The embolic deflection device 400 is configured to conform to the wall of the aortic arch 210 in the deployed state to cover the side branch vessels at the aortic arch 210. The embolus collection device 100 is coupled to the delivery device and is positioned between the embolus deflecting device 400 and the fourth proximal end. The embolic collecting device 100 is configured to extend along the wall of the descending aorta 230 in a deployed state, with the second distal end of the first filter element 130 forming an opening towards the embolic deflecting device 400. The delivery device is used to deliver the embolus deflecting device 400 and the embolus collecting device into a blood vessel.
In some embodiments, the delivery device comprises a first delivery tube 600 and an outer sheath 700, the embolus deflecting device 400 and the embolus collecting device 100 are respectively connected with the first delivery tube 600, the outer sheath 700 has a first inner cavity axially penetrating and used for accommodating the embolus deflecting device 400, the embolus collecting device 100 and the first delivery tube 600.
As shown in fig. 10-11 b, the amount of axial deformation of the embolic collecting device 100 when compressed needs to be taken into account when loading the embolic collecting device 100 onto the first delivery tube 600. Fig. 11a shows a first connection of the embolus collecting device 100 to the first delivery tube 600, which is illustrated by way of example with the embolus collecting device 100 provided in the first embodiment described above. As shown in fig. 11a, the proximal connector 110 has a first through hole penetrating in the axial direction, the distal connector 140 has a second through hole penetrating in the axial direction, the first transmission tube 600 is inserted into the first through hole of the proximal connector 110 and the second through hole of the distal connector 140, and the first transmission tube 600 penetrates through the embolus collecting device 100. The proximal connector 110 is fixedly connected to the first delivery tube 600, and the distal connector 140 is slidable along the axial direction of the first delivery tube 600. Fig. 11b shows a second connection of the embolus collecting device 100 to the first delivery tube 600. As shown in fig. 11b, the first delivery tube 600 penetrates through the embolus collecting device 100, and both the proximal connector 110 and the distal connector 140 can slide along the axial direction of the first delivery tube 600, and at the same time, a limiting protrusion 610 is further disposed on the first delivery tube 600, and the limiting protrusion 610 is located between the proximal connector 110 and the distal connector 140 to limit the sliding distance of the proximal connector 110 or the distal connector 140, so as to prevent the whole embolus collecting device 100 from being separated from the first delivery tube 600. In any connection manner, after the embolus collecting device 100 is loaded on the first delivery tube 600, the first delivery tube 600 is inserted into the first inner cavity of the sheath tube 500, and the embolus collecting device 100 can be compressed in the first inner cavity of the sheath tube 500 by pushing and pulling the first delivery tube 600.
It should be understood that the first connection is applicable to any of the embolic collecting device 100 described above (when the embolic collecting device does not have a distal connector, the first delivery tube is threaded only in the first through hole), while the second connection is applicable to embolic collecting device 100 having both a proximal connector 110 and a distal connector 140.
The emboli deflecting device 400 has third distal and proximal ends that are opposite, and the first delivery tube 600 can be connected to at least one of the third distal and proximal ends, so long as it is ensured that the emboli deflecting device 400 can be compressed.
In other embodiments, the delivery device comprises an outer sheath having a first lumen extending axially therethrough, a first delivery tube having a second lumen extending axially therethrough, and a second delivery tube; the embolus collecting device is connected to the first delivery tube, the embolus deflecting device is connected to the second delivery tube, the second lumen is configured to receive the embolus deflecting device and the second delivery tube, and the first lumen is configured to receive the embolus collecting device and the first delivery tube (not shown). That is, in these embodiments, the emboli deflecting device is delivered into the blood vessel via the second lumen, while the emboli collecting device is delivered into the blood vessel via the first lumen. Additionally, the second delivery tube is connected to at least one of a third proximal end and a third distal end of the embolus deflecting device.
During the operation, a contrast catheter (not shown) is further introduced into the blood vessel, and the contrast catheter can enter the blood vessel along the second lumen of the first delivery tube 600 or along the first lumen of the outer sheath 700 according to the diameters of the first delivery tube 600 and the outer sheath 700.
In addition, as previously mentioned, during the surgical procedure, it is also necessary to introduce a surgical instrument (e.g., a ventricular assist pump) into the blood vessel through the instrument delivery tube 500, and the instrument delivery tube 500 generally travels along the upper wall of the aorta, so that the depression of the embolus collecting device 100 is disposed toward the upper wall of the descending aorta 230.
Further, in this embodiment, the first delivery tube 600 has a fourth proximal end and a fourth distal end, which are opposite to each other, and the fourth distal end can be set in a bent structure to perform an orientation function, so that the embolus collecting device 100 can be smoothly delivered to a predetermined position in the blood vessel.
As shown in fig. 5, the embolus collecting method based on the embolic protection system comprises the following steps:
step S10, providing the embolic protection system;
step S20, delivering the embolic protection system into a blood vessel;
step S30, releasing the embolus deflecting device 400 at the aortic arch 210 and the embolus collecting device 100 in the descending aorta 230.
In fact, before introducing the embolic protection system into the blood vessel, a guide wire 800 with a diameter of 0.035mm should be pre-embedded along the femoral artery, and the delivery device should be guided by the guide wire 800 to guide the embolus deflecting device 400 and the embolus collecting device 100 into the blood vessel.
If the delivery device comprises a first delivery tube 600 and an outer sheath 700, the first delivery tube 600 has a second lumen for sheathing over the guide wire 800 and reaching a predetermined position along the guide wire 800. The embolus deflecting device 400 and the embolus collecting device 100 are respectively connected with the first delivery pipe 600, and the sheath tube 700 has a first inner cavity which is axially penetrated and is used for accommodating the embolus deflecting device 400, the embolus collecting device 100 and the first delivery pipe 600. At this time, the operation of step S30 is: sheath 700 is withdrawn to release the embolus deflecting device 400, and sheath 700 is continued to be withdrawn to release the embolus collecting device 100.
If the conveying device simultaneously comprises an outer sheath tube, a first conveying tube and a second conveying tube, the outer sheath tube is provided with a first inner cavity which is axially communicated, the first conveying tube is provided with a second inner cavity which is axially communicated, and the second conveying tube is provided with a third inner cavity which is axially communicated. Said embolus collecting device is connected to said first delivery tube, said embolus deflecting device is connected to said second delivery tube, said second lumen is adapted to receive said embolus deflecting device and said second delivery tube, said first lumen is adapted to receive said embolus collecting device and said first delivery tube; the third inner cavity is used for being sleeved on the guide wire and reaching a preset position along the guide wire. At this time, the operation of step S30 is: withdrawing said sheath and said first delivery tube simultaneously to release said embolic deflection device and withdrawing said sheath to release said embolic collection device.
Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims and their equivalents, the present invention is also intended to include such modifications and variations.
Claims (20)
1. An embolus collection device, comprising:
a proximal connector;
the first supporting element comprises a plurality of supporting rods which are arranged around an axis at intervals, at least part of the supporting rods are bent to form a concave surface facing the axis, each supporting rod is provided with a first near end and a first far end which are opposite along the direction parallel to the axis, and the first near end of each supporting rod is arranged on the near end connecting piece after being folded; and the number of the first and second groups,
a first filter element having a second proximal end and a second distal end opposite to each other, the first filter element being disposed on the first support element, the second proximal end being disposed on the first proximal end of the support rod, the second distal end being disposed on the first support element and forming an opening.
2. The embolic collecting device of claim 1, wherein said embolic collecting device is provided with a recess for forming a passageway therethrough along said axis between said embolic collecting device and an inner wall of a blood vessel.
3. The emboli collection device of claim 2, wherein the plurality of support rods comprises at least a first support rod, when the number of first support rods is two or more, the two or more first support rods are arranged adjacently; each of the first support rods has a local recessed structure with a convex side facing the axis, and the first filter element is attached to the local recessed structure of the first support rod to form the recess.
4. The embolic collecting device of claim 2, wherein said first filter element is attached to a surface of two adjacent support rods and has a local concave structure between the two adjacent support rods, a convex side of said local concave structure facing said axis to form said depression.
5. The embolic collecting device of claim 2, wherein said first filter element is attached to a surface of two adjacent support rods, said recess being formed between said two adjacent support rods when said first filter element is subjected to a force directed towards said axis.
6. The emboli collection device of claim 2, wherein the plurality of support rods comprises two adjacent second support rods, the gap between two adjacent second support rods is greater than the gap between the remaining two adjacent support rods; when the first filter element is subjected to a force directed towards the axis, the recess is formed between the two adjacent second support rods.
7. The emboli collecting device of claim 1, further comprising a distal connector, wherein said first distal end of each of said support rods is disposed on said distal connector when said first distal ends of said support rods are collapsed.
8. The embolic collecting device of claim 1, wherein said first support element has a first position, said first support element is configured such that in a deployed state said first support element abuts an inner wall of a blood vessel at said first position and said second distal end of said first filter element is disposed at said first position along a circumference of said first support element or said second distal end of said first filter element is disposed between said first position and said first distal end along a circumference of said first support element.
9. The embolic collecting device of claim 8, wherein said first location is not equidistant from said first proximal end and said first location is not equidistant from said first distal end in a direction parallel to said axis.
10. The embolic collecting device of claim 8, wherein said first location is the same distance from said first proximal end and said first location is the same distance from said first distal end in a direction parallel to said axis.
11. The embolic collecting device of any of claims 1-10, wherein said support rods are arranged at unequal intervals around said axis in a plane perpendicular to said axis.
12. The embolic collecting device of any of claims 1-10, wherein said first support element has a length in the range of 20mm-60mm in a direction parallel to said axis; the first support element has a maximum length in a direction perpendicular to the axis of 20mm to 40 mm.
13. An embolic protection system comprising a delivery device, an embolic deflection device, and an embolic collection device as in any of claims 1-12;
the delivery device has opposite fourth proximal and distal ends;
said embolus deflecting means is connected to said delivery means and comprises a second filtering element;
the embolus collecting device is connected to the delivery device and is located between the embolus deflecting device and the fourth proximal end.
14. The embolic protection system of claim 13, wherein said delivery device comprises a first delivery tube and an outer sheath, said embolic deflection device and said embolic collection device being respectively coupled to said first delivery tube, said outer sheath having a first lumen therethrough in an axial direction for receiving said embolic deflection device, said embolic collection device, and said first delivery tube.
15. The embolic protection system of claim 14, wherein the embolic deflection device has third distal and proximal opposing ends, the first delivery tube connecting the third distal and/or proximal ends.
16. The embolic protection system of claim 13, wherein the delivery device comprises an outer sheath having a first lumen therethrough in an axial direction, a first delivery tube having a second lumen therethrough in an axial direction, and a second delivery tube;
the embolus collecting device is connected with the first delivery tube, the embolus deflecting device is connected with the second delivery tube, the second inner cavity is used for accommodating the embolus deflecting device and the second delivery tube, and the first inner cavity is used for accommodating the embolus collecting device and the first delivery tube.
17. The embolic protection system of claim 16, wherein the embolic deflection device has third distal and proximal opposing ends, the second delivery tube connecting the third distal and/or proximal ends.
18. The embolic protection system of any of claims 14-17, wherein said proximal connector of said embolic collection device has a first through-hole therethrough in a direction parallel to said axis, said embolic collection device being sleeved on and fixedly connected to said first delivery tube through said first through-hole.
19. The embolic protection system of claim 18, wherein the embolic collection device further comprises a distal connector, the first distal end of the support rod is disposed on the distal connector after being collapsed, the distal connector has a second through hole extending therethrough in a direction parallel to the axis, and the distal connector is sleeved on the first delivery tube through the second through hole and is slidable on the first delivery tube in an axial direction of the first delivery tube.
20. The embolic protection system of any of claims 14-17, wherein the embolic collection device further comprises a distal connector, the first distal end of the support rod being disposed on the distal connector; the embolus collecting device is characterized in that the near-end connecting piece is provided with a first through hole which penetrates in a direction parallel to the axis, the far-end connecting piece is provided with a second through hole which penetrates in a direction parallel to the axis, the embolus collecting device is sleeved on the first conveying pipe through the first through hole and the second through hole, the first conveying pipe is further provided with a limiting bulge, and the limiting bulge is located between the near-end connecting piece and the far-end connecting piece and used for limiting the embolus collecting device to be separated from the first conveying pipe.
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| CN201922366087.5U CN211460682U (en) | 2019-12-25 | 2019-12-25 | Embolism collection device and embolism protection system |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2021104063A1 (en) * | 2019-11-28 | 2021-06-03 | 上海微创医疗器械（集团）有限公司 | Embolic protection device |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021104063A1 (en) * | 2019-11-28 | 2021-06-03 | 上海微创医疗器械（集团）有限公司 | Embolic protection device |
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