Catheter pump

Abstract

Disclosed is a catheter pump (1) comprising a catheter (10), a foldable pump head (30) having a pump housing containing an impeller (34) and attached to the distal end of the catheter (10), and a covering membrane (32) attached to the pump housing, and a drive shaft (50) rotatably disposed inside the catheter (10) and connected to the impeller (34), wherein the catheter (10) comprises a first segment (12) located inside the covering membrane (32), a second segment (14) located near the proximal end of the covering membrane (32) and extending from the first segment (12) toward the proximal end of the catheter, and a third segment (16) extending from the second segment (14) toward the proximal end of the catheter, wherein the rigidity of the first segment is less than that of the second segment, and the rigidity of the second segment is less than that of the third segment. By arranging three segments with varying rigidity, the catheter's ability to pass through curves during intervention can be improved, preventing deposition due to deformation of the coating membrane.

Description

Technical Field

[0001] This application claims the priority of a Chinese patent application filed with the China National Intellectual Property Administration on August 1, 2023, with the application number 202310957643.4 and the invention title "Catheter Pump", and all of its content is incorporated herein by reference.

[0002] Embodiments of the present disclosure generally relate to the field of medical devices, and in particular, to catheter pumps for pumping blood.

Background Art

[0003] A catheter pump is introduced into a patient's body by an interventional method to assist in the transportation of blood in the blood circulation system. A catheter pump generally includes a pump head portion inside the patient's body and a motor portion outside the patient's body. The motor portion is connected to the pump head portion by an elongated drive shaft disposed within the catheter to provide power to the pump head portion. As an example, when the pump head is disposed in the left ventricle, the catheter pump pumps blood from the left ventricle of the heart into the aorta, and when the pump head is disposed in the right ventricle, the catheter pump pumps blood from the inferior vena cava into the pulmonary artery.

[0004] The pump head portion, catheter, and drive shaft together are inserted into a predetermined interventional position (e.g., the left ventricle) within the patient's body. In the process of these members being inserted into the human heart along the blood vessels, since the blood vessels are not straight, these members need to have excellent flexibility and elasticity in order to have good blood vessel passing ability.

Summary of the Invention

Problems to be Solved by the Invention

[0005] Embodiments of the present disclosure aim to provide a catheter pump that improves one or more performances of the catheter pump.

Means for Solving the Problems

[0006] A catheter pump is provided according to a first aspect of the present disclosure. The catheter pump includes a catheter, a foldable pump head having a coating attached to the distal end of the catheter and containing an impeller inside, and a pump housing attached to the pump housing, and a drive shaft rotatably disposed inside the catheter and connected to the impeller, wherein the catheter includes a first segment located inside the coating, a second segment located near the proximal end of the coating and extending from the first segment toward the proximal end of the catheter, and a third segment extending from the second segment toward the proximal end of the catheter, wherein the stiffness of the first segment is less than that of the second segment, and the stiffness of the second segment is less than that of the third segment. By arranging three segments with varying stiffness, the ability of the catheter to pass through curves during the intervention process is improved and deposition due to deformation of the coating is prevented.

[0007] In some embodiments, the first segment, the second segment, and the third segment are manufactured from the same material.

[0008] In some embodiments, the outer diameter of the first segment is smaller than the outer diameter of the second segment, and the outer diameter of the second segment is smaller than the outer diameter of the third segment.

[0009] In some embodiments, the second segment has a shape in which its size gradually increases from the proximal end to the distal end.

[0010] In some embodiments, the second segment is cone-shaped.

[0011] In some embodiments, the difference between the average diameter of the proximal end of the second segment and the average diameter of the distal end of the second segment is in the range of 0.2 mm to 0.4 mm, and in particular, in the range of 0.25 mm to 0.35 mm.

[0012] In some embodiments, the size of the second segment is in the range of 5 mm to 20 mm, particularly in the range of 8 mm to 15 mm.

[0013] In some embodiments, the size of the third segment is in the range of 30 mm to 80 mm, particularly in the range of 50 mm to 60 mm. In some embodiments, the second segment is located outside the coating film. In some embodiments, the second segment extends at least partially into the interior of the coating film.

[0014] In some embodiments, the foldable pump head is convertible between an unfolded configuration corresponding to an operating state and a folded configuration corresponding to an intervention state, the catheter is pre-folded at the second segment, and when the foldable pump head is in the unfolded configuration, the pump head is supported by pre-folding stress formed at least partially from the pre-folding. In this way, the pump head is supported by pre-folding stress provided by the pre-folded portion, improving the centering performance of the pump head during operation. In some embodiments, the angle at which the catheter is pre-folded at the second segment is set such that, in the unfolded configuration, the coating membrane and the impeller are supported at the second segment substantially perpendicular to the organ tissue supporting the coating membrane. By ensuring that the pump head is supported to be centered in this way, it is prevented from moving away from the inner wall of the heart, preventing the inlet from adhering to the inner wall of the heart, or from drawing in and entangling cardiac chordae tendineae into the pump head.

[0015] In some embodiments, the catheter is pre-bent in the second segment to an angle in the range of 120° to 150°, particularly in the range of 130° to 140°.

[0016] In some embodiments, the pre-folding is formed during the process of integrally molding the catheter by injection molding. In this way, the size accuracy of the pre-folded portion can be ensured. In some embodiments, in the folded arrangement, the coating film and the impeller are arranged to fold from the distal end of the catheter toward the proximal end of the catheter.

[0017] A second aspect of the present disclosure provides a catheter pump, comprising a catheter, a drive shaft rotatably disposed inside the catheter, a pump housing, and a foldable pump head having a covering membrane attached to the pump housing, wherein the pump head is convertible between an unfolded configuration corresponding to an operating state and a folded configuration corresponding to an intervention state, in which case the covering membrane is arranged to fold from the distal end of the catheter toward the proximal end of the catheter, and the catheter comprises a distal end portion extending from the vicinity of the covering membrane toward the distal end of the catheter, and a proximal end portion continuous with the distal end portion and extending from the vicinity of the covering membrane toward the proximal end of the catheter, wherein the rigidity of the distal end portion is less than that of the distal end portion.

[0018] The above and other purposes, features, and advantages of the embodiments of this disclosure will be easier to understand by referring to the drawings and reviewing the following detailed description. The drawings illustrate, rather than limit, several embodiments of this disclosure. [Brief explanation of the drawing]

[0019] [Figure 1] This is a schematic diagram of the catheter pump according to an embodiment of the present disclosure. [Figure 2] This is a schematic diagram showing the catheter pump according to an embodiment of the present disclosure positioned in the left ventricle. [Figure 3] This is a local schematic diagram of the catheter of a catheter pump according to one embodiment of the present disclosure. [Figure 4]It is a schematic diagram of the state before folding of the pump head part of the catheter pump according to an embodiment of the present disclosure. [Figure 5] It is a schematic diagram of the state during the folding process of the pump head part of the catheter pump according to an embodiment of the present disclosure. In each drawing, the same or corresponding reference numerals indicate the same or corresponding parts.

Mode for Carrying Out the Invention

[0020] Hereinafter, preferred embodiments of the present disclosure will be described in more detail with reference to the drawings. The drawings show preferred embodiments of the present disclosure, but are not limited to the embodiments described herein, and the present disclosure can be realized in various forms. By providing these embodiments, the present disclosure becomes more thorough and complete, and the scope of the present disclosure can be fully conveyed to those skilled in the art.

[0021] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention do not limit the present invention, but are merely used to explain specific embodiments. The term "and / or" used in this specification includes any and all combinations of one or more related items.

[0022] The term "comprising" and its variations used in this specification indicate an open "comprising", that is, "including but not limited to this". Unless otherwise explained, the term "or" indicates "and / or". The term "based on" indicates "at least partially based on". The terms "one exemplary embodiment" and "one embodiment" indicate "at least one exemplary embodiment". The term "another embodiment" indicates "at least one another embodiment".

[0023] The terms "proximal", "distal", "front", "rear", "inner", and "outer" used in the present disclosure are orientations with respect to a clinician operating a catheter pump. The terms "proximal" and "rear" refer to parts relatively close to the clinician, and the terms "distal" and "front" refer to parts relatively far from the clinician. For example, the external part of the catheter is located at the proximal end and the front end, and the part of the catheter inserted into the body is located at the distal end and the rear end. Here, the orientations of "proximal", "distal", "rear", "front", "inner", and "outer" are definitions for facilitating explanations. Since the catheter pump can be used in many directions and positions, these terms expressing relative positional relationships are not restrictive and absolute. In the present disclosure, if there are other obvious regulations and limitations for the above definitions, the above obvious regulations and limitations shall be followed. Hereinafter, a catheter pump according to an embodiment of the present disclosure will be described in conjunction with the drawings.

[0024] FIG. 1 shows an overall schematic view of a catheter pump 1 according to an embodiment of the present disclosure. The catheter pump 1 is generally at least partially inserted into a patient's body, for example, arranged at a predetermined position in the left ventricle or the right ventricle to pump blood and at least partially used in place of the pumping function of the heart.

[0025] The catheter pump 100 includes a catheter 10, a motor 20, and a pump head 30. The motor 20 is connected to the proximal end of the catheter 10 by a coupler and is arranged to provide power as a power member. The distal end of the catheter 10 is connected to the pump head 30. A drive shaft 50 is provided inside the catheter 10 (see FIG. 3), and one end of the drive shaft 50 is connected to the power output end of the motor 20. The distal end of the catheter 10 is connected to the pump head 30.

[0026] The pump head 30 includes a pump housing and an impeller 34 (see Figure 5) mounted within the pump housing, the impeller 34 being connected to the other end of the drive shaft 50. Thus, when the drive shaft 50 rotates, it rotates the impeller along with it. The pump housing includes a bracket of a metal grid manufactured from an alloy such as nickel or titanium. The metal grid of the pump housing has a mesh design. A coating 32 is attached to the pump housing and, together with the pump housing, defines an inlet 31 for pumping blood in and an outlet 33 for pumping blood out. In some embodiments, the coating 32 covers the rear end portion of the pump housing (i.e., the portion closer to the proximal end of the pump housing), so that the coating 32 forms an outlet 33 for blood at the proximal end, and the front end portion of the pump housing (i.e., the distal end), which is not covered by the coating 32, forms an inlet 31 for blood, for example, the inlet is formed by the mesh of the pump housing. As the drive shaft 50 rotates the impeller, the blood enters the fluid passage restricted by the coating membrane 32 from the inlet 31 and flows out from the outlet 32 ​​through the coating membrane as the impeller rotates.

[0027] In some embodiments, the pump head 30 is foldable. This contributes to the human intervention of the catheter pump 1. Since the pump head 30 and the front end portion of the catheter 10 of the catheter pump are delivered into and held in the patient's body, it is desirable that the outer circumference size of the pump head 30 and catheter 10 be as small as possible. A small pump head 30 and catheter 10 can enter the patient's body through a small puncture site, reducing patient pain during the intervention process and decreasing complications caused by an oversized puncture site. According to embodiments of this disclosure, the pump head 30 includes a folded configuration and an unfolded configuration. In the folded configuration, the pump head 30 is in a folded state, occupying the smallest outer circumference size, and the folded configuration corresponds to the intervention process of the catheter pump 10. In the unfolded configuration, the pump head 30 returns from the folded configuration to an unfolded state, and the unfolded configuration corresponds to the operating state of the catheter pump 10, in which state the blood pumping passage of the pump head 30 is smooth and suitable for blood pumping.

[0028] In some embodiments, the pump housing of the pump head 30 is manufactured from an alloy material such as nickel or titanium. The pump head 30 is implemented as a multi-mesh design and deploys using the memory properties of nickel or titanium alloys. The impeller blades are manufactured from a flexible or shape-memory material and are foldable relative to the wheel hub. In the folded configuration of the pump head 30, the impeller blades approach the wheel hub, reducing their occupied size. After the external forces constraining the impeller blades are released, the stored energy of the blades is released to deploy the blades, and then they are returned to the deployed state.

[0029] The catheter pump 1 further includes a protective head 40 connected to the distal end of the pump head 30. During the process of intervening the catheter pump 1 in a predetermined position in the human body, the protective head 40 guides the intervention of the catheter pump. After the catheter pump 1 has been intervened in a predetermined position in the human body (i.e., after the catheter pump is positioned), during the operation of the catheter pump 1, the protective head 40 can maintain the posture of the pump head in the heart, preventing the pump head from being attracted to the inner wall of the heart or causing danger by drawing the chordae tendineae into the pump head. To avoid damaging the patient's tissue, the protective head 40 is softly positioned. In some embodiments, the soft end of the protective head 40 is supported by the ventricular wall in a non-invasive or non-destructive manner, separating the inlet 31 of the pump head 30 from the ventricular wall. In the illustrated embodiment, the protective head 40 is linear in shape, where the illustrated shape is illustrative only, and the protective head 40 may be any other suitable shape.

[0030] Figure 2 shows a schematic diagram of a catheter pump 1 positioned in the left ventricle according to an embodiment of the present disclosure. Herein, the illustrated embodiment is illustrative only, and the catheter pump may be intervened in other target locations in the patient, such as the right ventricle, blood vessels, or other organs, as desired by interventional surgery.

[0031] Since the pathway for the catheter pump 1 to intervene at a predetermined location inside the human body from outside the body is not a straight path, the catheter 10 of the catheter pump 1 is generally manufactured from a flexible material, thereby giving the catheter 10 sufficient contour-following ability. After numerous tests, the inventors of this application have found that if the catheter 10 has a constant rigidity within a long size range, particularly from the pump head to the proximal end of the catheter, the catheter 10's ability to pass through blood vessels is insufficient. In other words, the catheter 10's ability to pass through curves is insufficient.

[0032] Depending on the required positioning of the catheter pump 1, it is desirable that the catheter 10 has a certain degree of rigidity. When the catheter pump 1 is in the operating state shown in Figure 2, the pump head 30 of the catheter pump 1 needs to be as centered as possible with respect to the cardiac tissue supporting the pump head 30. One purpose of centering is to prevent the pump head from moving away from the inner wall of the heart, preventing the inlet from being attracted to the inner wall of the heart, or from drawing in and entangling cardiac chordae tendineae into the pump head. However, when operating the catheter pump 1, the pump suction action by the blood fluid generates a lot of reaction force against the pump head 30, causing the position of the pump head 30 to shift. Under conditions where the catheter 10 has sufficient rigidity, the rigidity of the catheter and the protective head 40 work together to maintain the position of the pump head as much as possible.

[0033] Furthermore, in order to have better contour-following ability, it is desirable that the catheter 10 be as flexible as possible. In the embodiment shown in Figure 2, during the process of positioning the catheter 10 along the contour of the blood vessel wall to the state shown in Figure 2 by the intervention method, the catheter 10 passes through areas of high curvature of the blood vessel, for example, the area of ​​the aortic arch in Figure 2. In these areas of high curvature, there is a high risk that the catheter 10 will come into contact with the inner wall of the aortic arch, making it impossible to advance it continuously. In this case, it is desirable that the catheter 10 has sufficiently low rigidity in order to have good bending passage ability.

[0034] To address the above problem, embodiments of this disclosure provide a catheter 10 having variable stiffness. In particular, the portion of the catheter 10 near the proximal end has high stiffness, while the portion near the distal end has less stiffness than the portion near the proximal end. Here, the term “portion near the proximal end” refers to the region where the coating of the pump head 30 is located, i.e., the portion near the proximal end relative to the region where the coating of the pump head 30 is located. In some embodiments, as shown in Figure 2, the “portion near the proximal end” corresponds to the region indicated by reference numeral 16 (i.e., the third segment). The region indicated by reference numeral 16 corresponds to the region with the greatest curvature during placement in the heart (i.e., the region where the maximum bending ability of the catheter 10 is required), and in the placement scenario of Figure 2, it corresponds to the region extending from the aortic arch to the vicinity of the pump head. The stiffness of the portion of the catheter 10 from segment 16 to the connection to the motor 20 is equal to or greater than the stiffness of segment 16. Similarly, the "portion near the distal end" is the portion of the pump head 30 that is close to the distal end relative to the region where the coating film is located. In some embodiments, as shown in Figure 2, the "portion near the distal end" corresponds to the regions indicated by reference numerals 12 and 14.

[0035] According to this disclosure, the "proximal end portion" occupies a large area of ​​the catheter 10 and can provide sufficient basic rigidity to the catheter. This basic rigidity provides sufficient rigid support to the pump head 30 in the area adjacent to the pump head, thereby ensuring that the pump head is "centered" during operation of the catheter pump. The "distal end portion" corresponds to the area where the pump head is located and / or the area near the pump head, and occupies only a part of the distal end area of ​​the catheter 10. The reduced rigidity of the "distal end portion" provides good bending ability for the anterior part of the catheter. This ensures that the catheter 10 is guided to the position of the catheter pump 1 without any problems.

[0036] In some embodiments, differences in stiffness are provided by selecting different materials. Specifically, the portion of the catheter near the distal end and the portion near the proximal end are manufactured from materials with different stiffness, thereby providing stiffness through the difference in materials. Additionally or alternatively, the portion of the catheter near the distal end and the portion near the proximal end are manufactured from the same material, and different stiffnesses are provided by forming the distal and proximal portions to have different sizes. For example, the outer diameter of the distal portion of the catheter is larger than the outer diameter of the proximal portion.

[0037] In some embodiments, the "distal end portion" is further divided into multiple regions having different stiffnesses to further improve the performance of the catheter pump. In some embodiments, as shown in Figure 2, the "distal end portion" indicated by reference numerals 12 and 14 includes a first segment 12 and a second segment 14 located near the proximal end of the coating membrane 32 and continuous with the first segment 12. The first segment 12 is located inside the coating membrane 32 and corresponds to the distal end portion of the catheter. The second segment 14 is located near the proximal end of the coating membrane 32 and continuous with the first segment 12. Here, the second segment 14 corresponds to the transition region between the third segment 16 and the first segment 12. The first segment 12 and the second segment 14 have different stiffnesses. In particular, the stiffness of the first segment 12 is less than that of the second segment 14, and the stiffness of the second segment 14 is less than that of the third segment 16. By arranging multiple regions with different rigidities, the problems caused by the folding of the pump head 30 are compensated for, and other additional technical effects are achieved, which will be described in detail below.

[0038] In some embodiments, differences in stiffness are provided by selecting different materials. That is, the first segment 12, the second segment 14, and the third segment 16 are manufactured from different materials, and the difference in materials provides the stiffness. In some other embodiments, the first segment 12, the second segment 14, and the third segment 16 are manufactured from the same material but are formed to have different sizes, thereby providing different stiffness. For example, the outer diameter of the first segment 12 is smaller than the outer diameter of the second segment 14, and the outer diameter of the second segment 14 is smaller than the outer diameter of the third segment 16.

[0039] In some embodiments, the second segment 14 has a shape that gradually increases in size from the proximal end to the distal end. In some embodiments, as shown in Figure 3, the second segment 14 is conical (including a frustum). Such a tapering shape better removes or reduces deposition due to deformation of the coating. In some embodiments, the difference between the average diameter of the proximal end of the second segment 14 and the average diameter of the distal end of the second segment 14 is in the range of 0.2 mm to 0.4 mm, particularly in the range of 0.25 mm to 0.35 mm. As can be seen from many tests, the above numerical range is effective in improving the bending ability of the catheter and the performance of deposition due to deformation of the coating. Here, the shapes shown are illustrative only, and the first segment 12, second segment 14 and third segment 16 may be formed into any suitable shape, as long as the above rigidity requirements are met. In some embodiments, the second segment 14 is located near the proximal end of the coating 32. The difference in rigidity between the second segment 14 and the first segment 12 can compensate for or mitigate deposition due to deformation of the coating film when the pump head 30 is folded.

[0040] In some embodiments, the third segment 16 corresponds to a region of the catheter with high bending requirements. In the placement scenario of Figure 2, it corresponds to a region extending from the aortic arch to the vicinity of the pump head. In some embodiments, the size of the third segment 16 is in the range of 30 mm to 80 mm, particularly in the range of 50 mm to 60 mm. As can be seen from testing for the above size range, the above size range can satisfy the rigidity requirements. Here, the size range of the third segment is illustrative only, and depending on the application scenario of the catheter pump and individual differences, the third segment may be set to other suitable size ranges. In this specification, size refers to the length of the segment.

[0041] When the pump head 30 of the catheter pump is interposed along a blood vessel to the position to be placed, if the impeller and housing of the pump head 30 are folded (for example, the impeller and housing are folded from the distal end to the proximal end, see Figures 4 and 5, which will be explained below), the covering membrane 32 is also folded together. However, since the covering membrane 32 itself is flexible, when the pump head 30 is advanced along the blood vessel, for example, the covering membrane 32 is deformed by the action of blood and / or propulsion force, and these deformations are undesirable. Furthermore, these deformations increase the resistance when the pump head 30 is advanced, and if the deformation is severe, the accumulation due to the deformation may affect the performance of the pump head 30. By providing increased rigidity from the second segment 14 to the first segment 12, the accumulation of the covering membrane due to the above deformation can be mitigated or removed, and by providing decreased rigidity from the second segment 14 to the third segment 16, the ability of the catheter to pass through curves can be improved.

[0042] In some embodiments, the second segment 14 is located outside the proximal end of the coating 32 and adjacent to the proximal end of the coating 32. In some embodiments, the second segment 14 extends at least partially into the interior of the coating 32. In some embodiments, the size of the second segment 14 is in the range of 5 mm to 20 mm, particularly in the range of 8 mm to 15 mm. As can be seen from many tests, the above numerical range is effective in improving the bending ability of the catheter and the performance of deposition due to deformation of the coating.

[0043] In some embodiments, the catheter 10 enhances the performance of the second segment 14 by further arranging several auxiliary means in the second segment 14. In some embodiments, the catheter 10 is pre-bent in the second segment 14. Here, the term “pre-bent” is a molding process, and “pre-bent” straightens the catheter by applying an external force to the catheter 10 (e.g., during the process of inserting the catheter 10 into the human body). Due to the external force acting in the second segment 14, the catheter 10 is straightened, and after the external force constraining the catheter 10 is removed (e.g., after the pump head of the catheter pump 1 is positioned in the intended location), the catheter 10 is held in the pre-bent shape in the second segment 14.

[0044] The pre-folding of the second segment 14 supports the membrane 32 at least partially by pre-folding stress when the foldable pump head 30 is in the deployed position. In this case, the orientation of the pump head 30 relative to the organ tissue 70 can be ensured. In the deployed position, the membrane 32 and impeller 34 are supported by the second segment 14 so as to be substantially perpendicular to the vascular tissue to support the membrane 32. This keeps the pump head away from the inner wall of the heart, preventing the inlet from adhering to the inner wall of the heart or drawing in and entangling cardiac chordae tendineae into the pump head. In some embodiments, the catheter 10 is pre-folded at the second segment 14 to an angle in the range of 120° to 150°, particularly in the range of 130° to 140°. As can be seen from many clinical trials, when the pump head is in the operating position, the final folded angle allows the pump head to be centered.

[0045] Pre-bending can be achieved in many ways. In some embodiments, the catheter 10 is integrally formed by injection molding, and the pre-bending is formed during the process of integrally forming the catheter 10 by injection molding. In some embodiments, after forming the catheter for integral molding, the catheter 10 is heat-treated to bend it into a predetermined shape by the heat treatment. For example, the catheter 10 may be annealed to form a curved structure, or other heat treatments may be considered to form the pre-bending. For example, the catheter 10 is heated on the core axis for molding to form the pre-bending. If the size requirements of multiple segments are taken into consideration, forming the pre-bending during the process of integrally forming the catheter 10 by injection molding contributes to ensuring size accuracy.

[0046] After the catheter 10 forms a pre-bend at a predetermined site, a corrective force is applied to the catheter 10, straightening the pre-bent portion of the catheter. After the corrective force is removed, the catheter 10 returns to its pre-formed curved state in a relaxed state.

[0047] As described above, the pump head 30 of the catheter pump 1 according to the embodiment of this disclosure is a foldable pump head. In order to reduce the volume occupied by the pump head, the catheter pump 1 needs to be folded before it is inserted into the human body. Figures 4 and 5 show schematic diagrams of the state of the pump head of the catheter pump 1 according to the embodiment of this disclosure before and after it is folded.

[0048] Figure 4 shows a schematic diagram of the state of the pump head 30 of the catheter pump 1 before it is folded, according to an embodiment of the present disclosure. As shown in Figure 4, an introduction device 60 is provided which is spaced apart and includes a funnel-shaped base 62 that gradually decreases in size and an intervention tube 64. The shape of the base 62 contributes to the biasing force on the pump head 30, compressing the pump head 30 from an unfolded state to a folded state. Figure 5 shows a schematic diagram of the state of the pump head 30 folding process of the catheter pump 1 according to an embodiment of the present disclosure. As shown in Figure 5, first the pump head portion of the catheter pump 1 is inserted into the introduction device 60, and after the protective portion 40 of the catheter pump 1 passes through the base 62 and enters the intervention tube 64, the pump head 30 begins to enter the base 62. The cavity wall of the base 62 contacts the pump head 30, applying a compressive force to the pump head 30. Due to the action of the compressive force, the pump head 30 folds from the distal end to the proximal end of the catheter 10. In particular, the pump housing and impeller 34 of the pump head fold from the distal end to the proximal end of the catheter 10, forming a compact arrangement.

[0049] The folded pump head 30 then enters the intervention tube 64 and maintains its compact position due to the compressive action of the walls of the intervention tube 64. Subsequently, the catheter pump 1 is continuously advanced so that the pump head portion of the catheter pump 1 and the catheter 10 are gradually advanced to the position where the catheter pump 1 is intended to be placed. During the intervention process, since the coating 32 of the pump head 30 is made of a flexible material, material deposition occurs in the coating at the distal end of the pump head as the pump head portion of the catheter pump 1 and the catheter 10 are continuously advanced, and such material deposition is undesirable. According to the embodiment of this disclosure, the catheter 10 forms segments 12 and 14 with different stiffnesses in the region near the coating 32, in particular the second segment 14 having greater stiffness than the first segment. The increased stiffness ensures good bending ability of the catheter 10 and effectively reduces or mitigates material deposition in the coating.

[0050] Furthermore, although each operation is described in a specific order, such operations are required to be performed in a specific order or sequence shown, or all illustrated operations are required to be performed in order to obtain the desired result. In certain environments, multitasking and parallel processing may be advantageous. Similarly, although some specific implementation details are included in the above discussion, these do not limit the scope of this disclosure. Some features described in the descriptions of individual embodiments may be implemented in a single implementation so as to be combined. Also, each feature described in the description of a single implementation may be implemented in multiple implementations in the form of individual or appropriate any subcombination.

[0051] Although the theme has been described in the specific language of structural features and / or method logic operation, the theme limited to the claims is not necessarily limited to the specific features or operations described above. Furthermore, the specific features and operations described above are merely exemplary forms of realizing the claims.

[0052] The above has already described the embodiments of this disclosure, and the above description is not exhaustive, but illustrative, and not limited to the embodiments disclosed. Many modifications and changes will be obvious to those skilled in the art, provided they do not deviate from the scope and spirit of the embodiments described. The terminology used herein is intended to best convey the principles, practical applications, or improvements to the prior art of each embodiment, or to enable other those skilled in the art to understand the embodiments disclosed herein.

Claims

1. It is a catheter pump, Catheter (10), A foldable pump head (30) comprises a pump housing that contains an impeller (34) and is attached to the distal end of the catheter (10), and a covering membrane (32) attached to the pump housing, The catheter (10) includes a drive shaft (50) which is rotatably positioned inside the catheter (10) and connected to the impeller (34), The catheter pump comprising a catheter (10) including a first segment (12) located inside the covering membrane (32), a second segment (14) located near the proximal end of the covering membrane (32) and extending from the first segment (12) toward the proximal end of the catheter (10), and a third segment (16) extending from the second segment (14) toward the proximal end of the catheter (10), wherein the rigidity of the first segment (12) is less than that of the second segment (14), and the rigidity of the second segment (14) is less than that of the third segment (16).

2. The catheter pump according to claim 1, wherein the first segment (12), the second segment (14), and the third segment (16) are manufactured from the same material.

3. The catheter pump according to claim 2, wherein the outer diameter of the first segment (12) is smaller than the outer diameter of the second segment (14), and the outer diameter of the second segment (14) is smaller than the outer diameter of the third segment (16).

4. The catheter pump according to claim 3, wherein the second segment (14) has a shape in which the size gradually increases from the proximal end to the distal end.

5. The catheter pump according to claim 4, wherein the second segment (14) is cone-shaped.

6. The catheter pump according to claim 4, wherein the difference between the average diameter of the proximal end of the second segment (14) and the average diameter of the distal end of the second segment (14) is in the range of 0.2 mm to 0.4 mm, particularly in the range of 0.25 mm to 0.35 mm.

7. The catheter pump according to claim 1, wherein the size of the second segment (14) is in the range of 5 mm to 20 mm, and more particularly in the range of 8 mm to 15 mm.

8. The catheter pump according to any one of claims 1 to 7, wherein the size of the third segment (16) is in the range of 30 mm to 80 mm, and in particular in the range of 50 mm to 60 mm.

9. The catheter pump according to any one of claims 1 to 7, wherein the second segment (14) is located outside the coating film (32).

10. The catheter pump according to any one of claims 1 to 7, wherein the second segment (14) extends at least partially into the interior of the coating film (32).

11. The catheter pump according to any one of claims 1 to 7, wherein the foldable pump head (30) is convertible between an unfolded configuration corresponding to an operating state and a folded configuration corresponding to an intervention state, the catheter (10) is pre-folded at the second segment (14), and when the foldable pump head (30) is in the unfolded configuration, the pump head (30) is supported at least partially by the pre-folding stress due to the pre-folding.

12. The catheter pump according to claim 11, wherein the angle at which the catheter (10) is pre-bent in the second segment (14) is such that, i.e., in the unfolded configuration, the coating membrane (32) and the impeller (34) are supported in the second segment (14) substantially perpendicular to the organ tissue for supporting the coating membrane (32).

13. The catheter pump according to claim 11, wherein the catheter (10) in the second segment (14) is pre-bent to an angle in the range of 120° to 150°, particularly in the range of 130° to 140°.

14. The catheter pump according to claim 11, wherein the pre-bending is formed during the process of integral molding of the catheter (10) by injection molding.

15. The catheter pump according to claim 11, wherein in the folded arrangement, the covering membrane (32) and the impeller (34) are arranged to fold from the distal end of the catheter (10) toward the proximal end of the catheter (10).

16. It is a catheter pump, Catheter (10), A drive shaft (50) is rotatably disposed inside the catheter (10), The invention includes a pump housing and a foldable pump head (30) having a coating film (32) attached to the pump housing, The pump head (30) is convertible between an unfolded configuration corresponding to the operating state and a folded configuration corresponding to the intervention state, and in the folded configuration, the covering membrane (32) is arranged to fold from the distal end of the catheter (10) toward the proximal end of the catheter (10). The catheter pump comprises a catheter (10) including a portion near the distal end that extends from the vicinity of the covering membrane (32) to the distal end of the catheter, and a portion near the proximal end that is continuous with the portion near the distal end and extends from the vicinity of the covering membrane (32) toward the proximal end of the catheter (10), wherein the rigidity of the portion near the distal end is less than the rigidity of the portion near the distal end.

Images