Disclosure of Invention
Based on this, there is a need for an improved percutaneous blood pump and a basket therefor, which solves at least one of the above technical problems.
A basket for a percutaneous blood pump comprises an expandable tube body, wherein the expandable tube body is provided with an impeller area and a distal end area which are connected, the impeller area and the distal end area are arranged along the axial direction of the expandable tube body, the impeller area is used for containing an impeller of the percutaneous blood pump, and the pipe diameter of the impeller area is larger than that of the distal end area in the expansion state of the expandable tube body.
In one embodiment, the basket further comprises a transition region connecting the impeller region and the distal end region; from the impeller region to the distal end region, the tube diameter of the transition region gradually decreases.
In one embodiment, the length of the transition zone is between 5% and 10% of the length of the expandable tubular body.
In one embodiment, the diameter of the tube of the distal end region tapers away from the impeller region.
In one embodiment, the length of the distal region is 55% to 65% of the length of the expandable tubular body.
In one embodiment, the expandable tubular body comprises a plurality of circumferential rings arranged axially in series, the expandable tubular body further comprising circumferential connectors connecting adjacent circumferential rings;
wherein the width of the circumferential connection at the transition zone is greater than the width of the circumferential connection at the impeller zone and/or distal zone; or the width of the circumferential connection piece at the junction of the impeller region and the transition region and/or at the junction of the transition region and the distal region is greater than the width of the circumferential connection piece at other regions of the impeller region, the transition region and the distal region.
In one embodiment, the circumferential connector at the impeller region of the expandable tubular body and/or at the distal region of the expandable tubular body has a width of 0.45mm to 0.65 mm; the width of the circumferential connecting piece positioned in the transition area of the expandable pipe body is 0.8 mm-1.0 mm.
In one embodiment, the expandable tubular body comprises a plurality of circumferential rings arranged axially in series, the expandable tubular body further comprising circumferential connectors connecting adjacent circumferential rings;
wherein the width of the circumferential connection at the junction of the impeller region and the distal region of the expandable tubular body is greater than the width of the circumferential connection at regions of the impeller region and the distal region of the expandable tubular body other than the junction.
In one embodiment, the circumferential connector at the junction of the impeller region and the distal region of the expandable tubular body has a width of 0.8mm to 1.0 mm; the width of the circumferential connecting piece positioned in the impeller area and the other areas of the far end area of the expandable pipe body except the connection position is 0.45-0.65 mm.
In one embodiment, the basket further comprises:
a first mouth region fixedly connected to an end of the distal region remote from the impeller region; and
a second mouth region fixedly connected to an end of said impeller region remote from said distal region;
wherein the tube diameter of the first mouth region gradually decreases in a direction away from the impeller region; the tube diameter of the second mouth region gradually decreases in a direction away from the distal end region; the expandable pipe body comprises a plurality of circumferential rings which are sequentially arranged along the axial direction, and the expandable pipe body further comprises circumferential connecting pieces which are connected with the adjacent circumferential rings; the width of the circumferential connection element at the first cuff area and/or the second cuff area is larger than the width of the circumferential connection element at the area between the first cuff area and the second cuff area.
In one embodiment the width of said circumferential connection element in said first cuff area and/or the width of said circumferential connection element in said second cuff area is between 1.0mm and 1.5 mm.
In one embodiment, each of the circumferential rings extends in a circumferential direction of the expandable tubular body and is in a wave shape, and each of the circumferential rings has a plurality of wave crests and wave troughs alternately arranged in sequence in the circumferential direction of the expandable tubular body; adjacent circumferential rings have partially overlapping regions in an axial direction of the expandable tubular body, and the circumferential connectors are located in the partially overlapping regions.
In one embodiment, the impeller region has a tube diameter greater than 1 times the tube diameter of the distal region and less than or equal to 2.5 times the tube diameter of the distal region.
In one embodiment, the diameter of the expandable tubular body in the impeller region is 7mm to 8mm, or the impeller region is cylindrical.
A percutaneous blood pump comprises the mesh basket and an impeller positioned in the impeller area, wherein the impeller comprises blades, and gaps are formed between the maximum outer diameter positions of the blades and the inner wall of the mesh basket in the impeller area.
In one embodiment, the gap is greater than 0.0254mm and equal to or less than 0.254 mm; or the radius of the blade is 2.8 mm-3.5 mm.
In the basket of the above embodiment, the impeller region of the expandable tubular body is adapted to be located within the aorta and the distal region of the expandable tubular body is adapted to be located within the left ventricle. On the one hand, because the pipe diameter of the impeller area of the expandable pipe body is larger than the pipe diameter of the far end area of the expandable pipe body, the expandable pipe body is not easy to move towards the left ventricle. Meanwhile, as the pipe diameter of the distal end area of the expandable pipe body is smaller than that of the impeller area of the expandable pipe body, when the basket exits from the left ventricle of the patient, the basket does not easily damage the aortic arch when passing through the aortic arch. On the other hand, because of adopting basket reducing structure, the pipe diameter in impeller district no longer is restricted by the size of aorta, the basket is located the interior partial external diameter of left ventricle unchangeable or reduces, the pipe diameter in impeller district enlarges compared with prior art, not only can increase the clearance between the inner wall of impeller and basket, effectively prevent impeller and basket inner wall from colliding, avoid serious hemolytic symptom, need not to increase the size of basket and aortic valve junction again, and can increase the radial dimension of impeller, under the prerequisite of guaranteeing 5L/min auxiliary flow, then can reduce the rotational speed of impeller, alleviate the phenomenon of generating heat of transmission parts such as bearing, pivot, reduce the thrombus phenomenon because the part generates heat and arouses.
Detailed Description
To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
It should be noted that when a portion is referred to as being "secured to" another portion, it can be directly on the other portion or there can be an intervening portion. When a portion is said to be "connected" to another portion, it may be directly connected to the other portion or intervening portions may be present. The terms "vertical," "horizontal," "left," "right," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
Referring to fig. 1, abasket 100 is provided according to an embodiment of the present disclosure. Thebasket 100 is intended to be mounted on a percutaneous axial blood pump (only the basket and impeller portions are shown). Thebasket 100 includes an expandable tubular body 110 (shown in schematic form). The expandabletubular body 110 has animpeller region 111 and adistal region 112 connected to theimpeller region 111. Theimpeller region 111 and thedistal region 112 are arranged along the axial direction of the expandabletubular body 110. Theimpeller region 111 is configured to receive animpeller 20 of a percutaneous axial blood pump.
A percutaneous axial blood pump includes abasket 100 and animpeller 20. Theimpeller 20 is located within animpeller region 111 of the expandabletubular body 110. In operation of the percutaneous axial blood pump, theimpeller region 111 is located within the aorta of the patient and thedistal region 112 is located within the left ventricle of the patient. The outer wall of the expandabletubular body 110 abuts against the aortic valve, and the expandabletubular body 110 is engaged with the aortic valve by the frictional force between the outer wall of the expandabletubular body 110 and the aortic valve, and is fixed in the heart of the patient.
When the percutaneous axial blood pump is in operation, the expandabletubular body 110 is in an expanded state. In the expanded state of the expandabletubular body 110, the tube diameter of theimpeller region 111 is greater than the tube diameter of thedistal region 112. Specifically, the tube diameter of the expandabletubular body 110 in theimpeller region 111 may be 7mm to 8mm, and the tube diameter of theimpeller region 111 may be greater than 1 time and equal to or less than 2.5 times the tube diameter of thedistal end region 112. The diameter of theimpeller section 111 may be uniform, and theimpeller section 111 is cylindrical. The tube diameter of thedistal end region 112 may also be uniform, such that thedistal end region 112 is cylindrical.
In this embodiment, the expandabletubular body 110 further includes atransition zone 113. Thetransition region 113 is located between theimpeller region 111 and thedistal end region 112. Thetransition region 113 is fixedly connected at one end to theimpeller region 111 and at the other end to thedistal region 112. The pipe diameter of the end of thetransition area 113 connected with theimpeller area 111 is equal to that of theimpeller area 111. The tube diameter at the end of thetransition region 113 that connects to thedistal end region 112 is equal to the tube diameter of thedistal end region 112. The tube diameter of thetransition region 113 decreases gradually from theimpeller region 111 to thedistal end region 112, and thetransition region 113 may be in a frustum shape, so that thetransition region 113 plays a role of gradually transitioning the tube diameter between theimpeller region 111 and thedistal end region 112. Preferably, the overall length of the expandabletubular body 110 may be 10mm to 15mm, and the length of thetransition region 113 is 5% to 10% of the overall length of the expandabletubular body 110.
When thebasket 100 is implanted in the heart of a patient, the outer wall of thetransition region 113 may be brought into abutment with the aortic valve such that the expandabletubular body 110 is engaged with the aortic valve to position the expandabletubular body 110. Specifically, the outer diameter of the expandabletubular body 110 at the engagement location of thetransition region 113 with the aortic valve may range from 7.5mm to 8.5 mm. Since the tube diameter of thetransition region 113 gradually increases from thedistal region 112 to theimpeller region 111, if the expandabletubular body 110 tends to slide from the aorta to the left ventricle, thetransition region 113 is easily engaged with the aortic valve, so that the expandabletubular body 110 is not easily slid from the aorta to the left ventricle. Meanwhile, the aortic valve is not easily damaged because the tube diameter of thetransition region 113 gradually decreases from theimpeller region 111 to thedistal end region 112, i.e., the tube diameter of thetransition region 113 is smaller at the position closer to the left ventricle.
Referring to fig. 2 and in conjunction with fig. 3, fig. 2 and 3 illustrate one particular implementation of the expandabletubular body 110, the expandabletubular body 110 includes a plurality of circumferential rings 1101. Thecircumferential ring 1101 extends in the circumferential direction of the expandabletubular body 110 and is an annular member having an undulating shape. Eachcircumferential ring 1101 has a plurality ofcrests 1101a andtroughs 1101b arranged circumferentially of the expandabletubular body 110 and alternating in sequence, thecircumferential ring 1101 further comprising a plurality oftie bars 1101 c. Each connectingbar 1101c connectsadjacent peaks 1101a andvalleys 1101 b.
Referring to fig. 1 and 2, when the expandabletubular body 110 is in a compressed state, eachcircumferential ring 1101 is radially compressed such that the connectingrods 1101c extend substantially in the axial direction of the expandabletubular body 110, and adjacent connectingrods 110,crests 1101a, andtroughs 1101b on thesame circumferential ring 1101 are respectively brought together. When the expandabletubular body 110 is in the expanded state, eachcircumferential ring 1101 is radially expanded, and adjacent connectingrods 1101c, crests 1101a, andtroughs 1101b of thesame circumferential ring 1101 are all spaced apart from one another.
Referring to fig. 4, a plurality ofcircumferential rings 1101 are sequentially arranged along the axial direction of the expandabletubular body 110. Adjacentcircumferential rings 1101 have a region of partial overlap in the axial direction of the expandabletubular body 110. Illustratively, the region designated by S in fig. 4 is the overlapping region occupied by adjacentcircumferential rings 1101 of the expandabletubular body 110 in the axial direction of the expandabletubular body 110. In fig. 4, 3 overlapping areas S are shown.
Thecircumferential ring 1101 also includes acircumferential connector 1101 d. Thecircumferential connection 1101d connects axially adjacentcircumferential rings 1101, and thecircumferential connection 1101d is located within the overlapping area S occupied by the adjacentcircumferential rings 1101 in the axial direction of the expandabletubular body 110.
Specifically, the circumferential connectingpiece 1101d connects two connectingrods 1101c on axially adjacentcircumferential rings 1101, the extending direction of the circumferential connectingpiece 1101d is the same as the extending direction of the connectingrods 1101c, and along the extending direction, the circumferential connectingpiece 1101d has a width W, and the circumferential connectingpiece 1101d has a length between two adjacent connectingrods 1101c, and of course, as a three-dimensional structure, a person skilled in the art should understand that the circumferential connectingpiece 1101d also has a thickness, and the description thereof is omitted.
Preferably, thecircumferential ring 1101 also comprises anaxial connector 1101 e. Theaxial connector 1101e connects thecrests 1101a of onecircumferential ring 1101 of two axially adjacentcircumferential rings 1101 with the connectingrods 1101c of the othercircumferential ring 1101.
Referring to fig. 1 to 5, in the present embodiment, preferably, the width W1 of thecircumferential connection 1101d at thetransition region 113 of the expandabletubular body 110 is greater than the width W2 of thecircumferential connection 1101d at theimpeller region 111 and the distal end region 112 (not shown in fig. 5), so as to enhance the axial connection strength of thetransition region 113, and effectively reduce or avoid the fracture of thetransition region 113. Meanwhile, the width W2 of thecircumferential connection 1101d between theimpeller region 111 of the expandabletubular body 110 and thedistal end region 112 of the expandabletubular body 110 is small, so that the expandabletubular body 110 is easy to bend at theimpeller region 111 and thedistal end region 112, and thus, excessive damage to the aortic arch when the expandabletubular body 110 passes through the aortic arch can be effectively reduced or avoided.
In this embodiment, the width W2 of thecircumferential connector 1101d is 0.45mm to 0.65mm in theimpeller region 111 of the expandabletubular body 110 and thedistal end region 112 of the expandabletubular body 110, and the width W1 of thecircumferential connector 1101d is 0.8mm to 1.0mm in thetransition region 113 of the expandabletubular body 110.
Of course, in other embodiments, the width of thecircumferential connection 1101d at the junction of thewheel region 111 and thetransition region 113 and/or at the junction of thetransition region 113 and thedistal end region 112 may be larger than the width of thecircumferential connection 1101d at other regions of thewheel region 111, thetransition region 113 and thedistal end region 112, which is not limited in the present invention.
Referring to fig. 1, thebasket 100 further includes a first andsecond outlet region 114 and 115. Thefirst mouth region 114 connects to an end of thedistal end region 112 remote from theimpeller region 111. The first necked-inregion 114 tapers in diameter in a direction away from thedistal region 112 in the first necked-inregion 114, thereby acting as a neck-in for one end of the expandabletubular body 110.
Thesecond mouth region 115 is connected to an end of theimpeller region 111 remote from thedistal end region 112. In a direction in which thesecond mouth region 115 is far from theimpeller region 111, the tube diameter of thesecond mouth region 115 is gradually reduced, thereby closing the other end of the expandabletubular body 110.
In one embodiment, thecircumferential connection 1101d at the first andsecond cuff areas 114, 115 of the expandabletubular body 110 has a width greater than the width of thecircumferential connection 1101d at the area between the first andsecond cuff areas 114, 115. In the present embodiment, the width of thecircumferential connection 1101d of the first andsecond mouth regions 114, 115 is greater than the width of thecircumferential connection 1101d of thewheel region 111, thetransition region 113 and thedistal end region 112, respectively. Thecircumferential connector 1101d may have a width of 1.0mm to 1.5mm in the first andsecond cuff areas 114 and 115 of the expandabletubular body 110. Since the first and second receivingareas 114 and 115 are respectively located at two ends of the expandabletubular body 110 and both perform a closing function, when the expandabletubular body 110 is compressed and expanded, the stress applied to the first and second receivingareas 114 and 115 is relatively large, and the width of the circumferential connectingpiece 1101d of the first and second receivingareas 114 and 115 is relatively long, which is beneficial to ensuring the circumferential connecting strength of the first and second receivingareas 114 and 115, and reducing or avoiding the fracture of the expandabletubular body 110 in the first and second receivingareas 114 and 115.
In other embodiments, the expandabletubular body 110 may also be configured such that thecircumferential connection 1101d at the first orsecond cuff area 114, 115 of the expandabletubular body 110 has a width that is greater than the width of thecircumferential connection 1101d at the area between the first andsecond cuff areas 114, 115.
In thebasket 100 of the above embodiment, theimpeller region 111 of the expandabletubular body 110 is configured to be located within the aorta, and thedistal region 110 of the expandabletubular body 110 is configured to be located within the left ventricle. In one aspect, the expandabletubular body 110 is less likely to wander from the left ventricle because theimpeller region 111 of the expandabletubular body 110 has a larger tube diameter than thedistal region 112 of the expandabletubular body 110. Meanwhile, since the tube diameter of thedistal end region 112 of theexpandable tube 110 is smaller than the tube diameter of theimpeller region 111 of theexpandable tube 110, the aortic arch is not easily damaged when thebasket 100 passes through the aortic arch when thebasket 100 exits from the left ventricle of the patient. On the other hand, due to the adoption of the basket reducing structure, the pipe diameter of theimpeller area 111 is not limited by the size of the aorta any more, the outer diameter of the part of thebasket 100 positioned in the left ventricle is unchanged or reduced, and the pipe diameter of theimpeller area 111 is enlarged compared with the prior art, so that not only can the gap between theimpeller 20 and the inner wall of thebasket 100 be increased, but also the impeller and the inner wall of the basket are effectively prevented from colliding, serious hemolysis symptoms are avoided, the size of the joint of the basket and the aortic valve is not required to be increased, and the radial size of theimpeller 20 can be increased, on the premise of ensuring 5L/min auxiliary flow, the rotating speed of theimpeller 20 can be reduced, the heating phenomena of transmission parts such as bearings and rotating shafts are reduced, and.
Another embodiment of the present application also provides a transcutaneous axial blood pump (not shown) comprising thebasket 100 of any of the embodiments described above and animpeller 20 located within theimpeller region 111.
Referring to fig. 6, theimpeller 20 includesblades 21. As described above, since the pipe diameter of theimpeller region 111 is larger than that of thedistal end region 112, the pipe diameter of theimpeller region 111 is larger, so that the size of theblade 21 can be increased, and further, thegap 101 between the inner wall of theimpeller region 111 and the maximum outer diameter of theblade 21 can be increased, so that the probability that theblade 21 collides with the inner wall of thebasket 100 during operation can be reduced. Because theclearance 101 between the inner wall of theimpeller area 111 and the maximum outer diameter of theimpeller 20 is increased, the shearing stress applied to blood flowing through the clearance can be reduced on the premise of ensuring the auxiliary flow of 5L/min, so that the damage of the shearing stress to blood cells is reduced, and the hemolysis symptom of a patient is improved.
In the present embodiment, theclearance 101 between the inner wall of theimpeller region 111 and the maximum outer diameter of theblades 21 is greater than 0.0254mm and 0.254mm or less. Specifically, the radius of theblade 21 may be 2.8mm to 3.5 mm. The diameter of the expandabletubular body 110 in theimpeller region 111 may be 7mm to 8 mm. Compared with the prior art, the outer diameter of the basket is 6-7mm, the outer diameter of the blade is 2.72mm, and the maximum gap between the inner wall of the basket and the impeller is 0.0254mm, in this embodiment, the pipe diameter of theexpandable pipe body 110 in theimpeller region 111 and the radius of theblade 21 can be significantly increased, and thegap 101 between the inner wall of theimpeller region 111 and the maximum outer diameter of theblade 21 is increased by 1-10 times compared with the prior art.
Referring to fig. 7, another embodiment of the present application further provides abasket 200. Thebasket 200 includes an expandabletubular body 210. The expandabletubular body 210 has animpeller region 211 and adistal region 212 connected to theimpeller region 211. Theimpeller region 211 and thedistal region 212 are arranged along the axial direction of the expandabletubular body 110. Theimpeller region 211 is configured to receive an impeller of a percutaneous axial blood pump. The structure of thebasket 200 is substantially the same as that of thebasket 100, and the description of the same parts is omitted. The following focuses on the differences between thebaskets 200 and 100.
Thedistal end region 212 tapers in tube diameter away from theimpeller region 211. Thebasket 200 is implanted in the patient's heart such that the outer wall of thedistal region 212 abuts the aortic valve and the expandabletubular body 210 is engaged by friction between the outer wall of thedistal region 212 and the aortic valve. Since the diameter of thedistal region 212 decreases in a direction away from theimpeller region 211, if the expandabletubular body 210 tends to slide from the aorta to the left ventricle, thedistal region 212 is easily engaged with the aortic valve, so that the expandabletubular body 210 is not easily slid from the aorta to the left ventricle. Meanwhile, the aortic valve is not easily damaged because the tube diameter of thedistal end region 212 gradually decreases in a direction away from theimpeller region 211, i.e., the tube diameter of thedistal end region 212 is smaller closer to the left ventricle. The overall length of expandabletubular body 210 may be between 10mm and 15mm, and the length ofdistal region 212 may be between 55% and 65% of the overall length of expandabletubular body 210.
In this embodiment, the width of the circumferential connecting piece at the joint of theimpeller region 211 and thedistal end region 212 is greater than the width of the circumferential connecting piece at the other region of theimpeller region 211 and thedistal end region 212 except for the joint, so that the circumferential connecting strength at the joint of theimpeller region 211 and thedistal end region 212 is enhanced, and the fracture at the joint of theimpeller region 211 and thedistal end region 212 can be effectively reduced or avoided. Meanwhile, the width of the circumferential connecting element 2101d of theimpeller region 211 of the expandabletubular body 210 and thedistal region 212 of the expandabletubular body 210 is small, so that the expandabletubular body 210 is easy to bend in theimpeller region 211 and thedistal region 212, and thus, excessive damage to the aortic arch when the expandabletubular body 210 passes through the aortic arch can be effectively reduced or avoided.
In the present embodiment, the width of the circumferential connection at the junction of theimpeller region 211 and thedistal end region 212 is 0.8mm to 1.0 mm. The width of the circumferential connection of theimpeller region 211 and thedistal end region 212 at regions other than the junction is 0.45mm to 0.65 mm.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.