Cardiovascular auxiliary pump with impeller having variable flow region

Abstract

To provide a mechanical cardiovascular auxiliary system generally used in a medical field to assist the movement of blood.SOLUTION: In particular, the present disclosure is directed to an impeller 2 having features that enable performance improvement. An annular flow region around the rotary impeller 2 may be variable along an axial length of the impeller 2. A first radial gap between the distal region of the impeller 2 and a tubular housing in the surrounding can be larger or smaller than a second radial gap between the proximal region of the impeller 2 and a tubular housing in the surrounding.SELECTED DRAWING: Figure 10

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application is a continuation of U.S. Provisional Patent Application No. 63 / 078207, filed September 14, 2020. No. 6,119,233, filed on Oct. 1, 2003, the entire disclosure of which is incorporated herein by reference in its entirety. be absorbed.

[0002] The present disclosure relates generally to mechanical cardiovascular assist devices used in the medical field to assist in the movement of blood. In particular, the present disclosure is directed to an impeller blade or shaft or auxiliary system. Optimized flow areas between other components and the surrounding inlet pipe, or specific stationary parts and possibly mechanical features that allow for improved performance, such as optimized spacing between moving parts; This applies to cardiovascular support devices. [Background technology]

[0003] [Description of Related Art] Mechanical circulatory assist devices are used to help a patient's heart pump blood around the body. They often have an electric motor, an inlet region at the distal end and an outlet region at the proximal end. a tubular inflow cannula that passes blood through the inflow cannula and into the outflow area; The device consists of an impeller rotated by a motor that passes through the or optimizing blood flow while minimizing the risk of damage to the blood. Higher blood flows than those provided by the device may be necessary for patients with mild cardiogenic shock or high risk However, this may improve outcomes for patients undergoing percutaneous coronary intervention. However, increased flow rates may also increase the risk of hemolysis or device damage.

[0004] Therefore, it allows for better blood flow while avoiding the risk of hemolysis or device damage, among other improvements. There is a need for improved mechanical circulatory support designs that can provide more Summary of the Invention

[0005] The present disclosure provides an impeller with a variable outer diameter or an impeller blade or impeller. a mechanical circulation assist system having a variable radial gap between the impeller and other components; and a tubular cannula containing an impeller. Each has multiple aspects, only one of which is responsible for the desirable properties of this disclosure. Without limiting the scope of this disclosure, its more prominent features will now be briefly described. After reviewing this description, please refer to the section entitled "Detailed Description of the Invention" in particular. After reading this section, it is understood that the features of the embodiments described herein are indicative of the existing mechanical circulatory assist system. You will understand how the present invention provides advantages over the systems, devices, and methods of .

[0006] The following disclosure describes non-limiting examples of some embodiments of mechanical circulatory assist devices. For example, other embodiments of the disclosed systems and methods include features described herein. Additionally, the benefits and advantages disclosed may or may not be present in a particular implementation. It is applicable only to the embodiments and should not be used to limit the present disclosure.

[0007] A first aspect of the present disclosure is a tubular crab including an inflow region, an outflow region, and a distal impeller region. and an impeller having a proximal end and a distal end, The impeller is at least partially within the outlet region and at least partially within the distal impeller region. The impeller is disposed within the tubular cannula, and radial gaps are formed between the impeller and the inner surface of the tubular cannula. The cap varies in size between the proximal and distal ends and has a specific position between the proximal and distal ends. The size of the radial gap at a particular position is determined by the maximum impeller width and the internal diameter of the tubular cannula. Includes the radial distance between the surface.

[0008] A second aspect of the present disclosure relates to the device of aspect 1, wherein the impeller is a distally tapered portion tapering distally to a diameter smaller than the first diameter; Sai.

[0009] A third aspect of the present disclosure relates to the device of aspect 2, wherein the impeller has a distally tapered portion. The stent includes a constant diameter portion extending proximally from the stent, the constant diameter portion having a first diameter.

[0010] A fourth aspect of the present disclosure relates to the device of aspect 3, wherein the constant diameter portion comprises at least one The impeller extends partially into the distal impeller region and at least partially into the outflow region.

[0011] A fifth aspect of the present disclosure relates to the device according to either of the third or fourth aspects, The diameter portion extends from the distally tapered portion to the proximal end of the impeller.

[0012] A sixth aspect of the present disclosure relates to the device of either aspect 3 or aspect 4, further comprising: an impeller includes a proximal narrowed diameter portion proximal to the constant diameter portion, The portion has a narrowed diameter that is smaller than the first diameter.

[0013] A seventh aspect of the present disclosure relates to the device of aspect 6, wherein the narrowed diameter is 0.5 mm smaller than the first diameter. 15mm~0.35mm smaller.

[0014] An eighth aspect of the present disclosure relates to the device according to any one of the sixth to seventh aspects, The radial gap at the narrowed diameter is the minimum radial gap in the distal impeller region. It is approximately 0.20 mm larger than the previous model.

[0015] A ninth aspect of the present disclosure relates to the device according to any one of the sixth to seventh aspects, The radial gap at the narrowed diameter is the minimum radial gap in the distal impeller region. It is approximately 0.125mm larger than the standard.

[0016] A tenth aspect of the present disclosure relates to the device according to any one of the second to ninth aspects, The axial gap is 0.095 mm to 0.125 mm at the distal diameter.

[0017] An eleventh aspect of the present disclosure relates to the device according to any one of the second to tenth aspects, The diameter gap is 0.060 mm to 0.090 mm at the first diameter position.

[0018] A twelfth aspect of the present disclosure relates to the device according to any one of aspects 2 to 11, wherein the distal diameter is 0.40 mm to 0.100 mm smaller than the first diameter.

[0019] A thirteenth aspect of the present disclosure relates to the device according to any one of the second to twelfth aspects, The slope of the tapered portion is approximately 0.0117.

[0020] A fourteenth aspect of the present disclosure relates to the device according to any one of the second to thirteenth aspects, The inner diameter of the cannula is 4.39 mm to 4.45 mm.

[0021] A fifteenth aspect of the present disclosure relates to the device according to any one of the second to fourteenth aspects, The length of the impeller is 7.5mm to 8.5mm.

[0022] A sixteenth aspect of the present disclosure relates to the device according to any one of the second to fifteenth aspects, The proximal end of the impeller is attached to the drive shaft.

[0023] A seventeenth aspect of the present disclosure relates to the device according to any one of the second to sixteenth aspects, The distal end of the impeller is the free end.

[0024] An eighteenth aspect of the present disclosure is any one of aspects 2 to 17, further including a motor housing. In one embodiment of the device, the motor housing is coupled to the proximal end of the inlet cannula. .

[0025] A nineteenth aspect of the present disclosure relates to the apparatus of aspect 1, further comprising a drive magnetic rotor; An impeller is coupled to the driving magnetic rotor.

[0026] A twentieth aspect of the present disclosure is a tubular cannula having a distal end adapted to hold the distal end of the impeller at the axial center of the cannula. 20. The apparatus of claim 19, further comprising a bearing configured as follows:

[0027] A twenty-first aspect of the present disclosure relates to the device of aspect 20, wherein the bearing is a tubular cannula. a bearing connected to the cannula and configured to maintain the position of the bearing relative to the tubular cannula; It includes multiple spokes formed.

[0028] A twenty-second aspect of the present disclosure relates to the device according to any one of the nineteenth to twenty-first aspects, The rotor is positioned at least partially in the outflow region.

[0029] A twenty-third aspect of the present disclosure relates to the device according to any one of the nineteenth to twenty-second aspects, The radial gap between the impeller and the inner surface of the tubular cannula is larger than the distal impeller region. The outflow area is larger than the basin area.

[0030] A twenty-fourth aspect of the present disclosure relates to the device according to any one of the nineteenth to twenty-third aspects, The radial gap between the impeller and the inner surface of the tubular cannula is larger than the distal impeller region. is also 2 to 3 times larger in at least part of the outflow region.

[0031] A twenty-fifth aspect of the present disclosure relates to the device according to any one of the nineteenth to twenty-second aspects, The impeller includes a constant diameter.

[0032] A twenty-sixth aspect of the present disclosure relates to the device according to any one of the nineteenth to twenty-five aspects, The impeller includes a first diameter in a distal impeller region, and the driving magnetic rotor is larger than the first diameter. The second diameter is within a smaller outflow area.

[0033] A twenty-seventh aspect of the present disclosure relates to the device according to the twenty-sixth aspect, The radial gap between the impeller and the inner surface of the tubular cannula is The second radial gap between the driving magnetic rotor and the tubular cannula is larger than the second radial gap between the driving magnetic rotor and the tubular cannula.

[0034] A twenty-eighth aspect of the present disclosure relates to the device according to the twenty-seventh aspect, The radial gap between the impeller and the inner surface of the tubular cannula is 0.065mm to 0.1 It is 50mm.

[0035] A twenty-ninth aspect of the present disclosure relates to the device according to any of the twenty-seventh or twenty-eighth aspects, The radial gap is the distance between the impeller and the inner surface of the tubular cannula at the first diameter. It is 2 to 3 times larger than the radial gap.

[0036] A thirtieth aspect of the present disclosure is a tubular capsule including an inflow region, an outflow region, and a distal impeller region. and within the tubular cannula in a portion of the outflow region and a portion of the distal impeller region. and an impeller positioned at the distal impeller region. The first radial gap between the impeller and the outlet region of the tubular cannula is It is smaller than the diagonal gap.

[0037] A thirty-first aspect of the present disclosure relates to the device of aspect 30, wherein the outflow area comprises one or more struts. include.

[0038] A thirty-second aspect of the present disclosure relates to the device according to any one of the thirty-first to thirty-first aspects, The impeller has a first diameter at a distal impeller region and a second diameter at an outflow region, is smaller than the first diameter.

[0039] A thirty-third aspect of the present disclosure relates to the device of aspect 32, wherein the first diameter is 3.8 mm to 5 It is within the range of 0.92mm.

[0040] A thirty-fourth aspect of the present disclosure relates to the device of aspect 32 or aspect 33, wherein the second diameter is It is in the range of 0.5mm to 5.92mm.

[0041] A thirty-fifth aspect of the present disclosure relates to the device according to any one of aspects thirty-second to thirty-fourth, The transition from the first diameter to the second diameter is a step transition.

[0042] A thirty-sixth aspect of the present disclosure relates to the device according to any one of aspects thirty-second to thirty-fourth, The transition from the first diameter to the second diameter is a sloped transition.

[0043] A thirty-seventh aspect of the present disclosure relates to the device according to any one of aspects thirty-second to thirty-fourth, The transition from the first diameter to the second diameter is a curved transition.

[0044] A thirty-eighth aspect of the present disclosure relates to the device according to any one of the thirty-first to thirty-first aspects, The roller has a constant diameter.

[0045] A thirty-ninth aspect of the present disclosure relates to the device according to any one of aspects 30 to 31 or 38. and further includes an insertion sleeve located within the distal impeller region.

[0046] A fortieth aspect of the present disclosure relates to the device of aspect 39, wherein the insertion sleeve is chamfered. The distal end includes a beveled distal end and a beveled proximal end.

[0047] A forty-first aspect of the present disclosure relates to an apparatus according to any one of aspects 39 or 40. The insertion sleeve is made from PEEK.

[0048] A forty-second aspect of the present disclosure relates to the device according to any one of the thirty-ninth to forty-first aspects, The insertion sleeve includes an inner surface having a lubricious coating.

[0049] A forty-third aspect of the present disclosure relates to the device according to any one of aspects thirty to forty-second, The first radial gap is in the range of 0.04 mm to 0.5 mm.

[0050] A forty-fourth aspect of the present disclosure relates to the device according to any one of the thirty-third to forty-third aspects, The second radial gap is in the range of 0.04 mm to 3 mm.

[0051] A forty-fifth aspect of the present disclosure relates to the device according to any one of aspects thirty to forty-four, The impeller is connected to the drive shaft of the motor.

[0052] A forty-sixth aspect of the present disclosure relates to the device according to any one of the thirty-fourth to forty-fourth aspects, The impeller is magnetically coupled to the motor.

[0053] A forty-seventh aspect of the present disclosure relates to the device according to any one of the thirty-sixth to forty-sixth aspects, The impeller includes at least two impeller blades.

[0054] A 48th aspect of the present disclosure is any one of aspects 30 to 47 in combination with aspect 31. For the described device, the strut has a thickness greater than the thickness of the tubular cannula.

[0055] A forty-ninth aspect of the present disclosure relates to the device according to any one of the thirty-ninth to thirty-seventh aspects, The impeller includes impeller blades in the distal impeller region, and the device has radially symmetric impeller blades in the outlet region. It further includes a conical shape.

[0056] A fiftieth aspect of the present disclosure relates to the device of aspect 49, wherein the radially symmetric conical shape comprises: It has an electropolished surface.

[0057] A fifty-first aspect of the present disclosure relates to a device according to any one of aspects forty-ninth or fifty-ninth. However, the radially symmetric cone shape includes a concave surface.

[0058] A fifty-second aspect of the present disclosure relates to the device according to any one of aspects forty-nin to fifty-first, The conical shape with symmetry includes a convex surface.

[0059] A fifty-third aspect of the present disclosure relates to the device according to aspect 52 in combination with aspect 51, is proximal to the concavity.

[0060] A fifty-fourth aspect of the present disclosure relates to the device according to any one of the forty-ninth to fifty-third aspects, The radially symmetrical cone shape is attached to or is part of the impeller shaft. do.

[0061] A fifty-fifth aspect of the present disclosure relates to the device according to any one of aspects forty-ninth to fifty-third, Radially symmetrical conical shape affixed to motor housing or tubular cannula or a part thereof.

[0062] A fifty-sixth aspect of the present disclosure relates to the device according to the fifty-fifth aspect, further comprising: an impeller shaft of the impeller. passes through the cone-shaped lumen.

[0063] A fifty-seventh aspect of the present disclosure relates to the device of the fifty-sixth aspect, wherein the bearing is It is positioned between the lid and the cone.

[0064] A fifty-eighth aspect of the present disclosure relates to the device of aspect fifty-six or fifty-seven, wherein the seal is It is positioned between the shaft and the cone shape. [Brief explanation of the drawings]

[0065] The foregoing and other features of the present disclosure are set forth in the following description and accompanying drawings, taken in conjunction with the accompanying drawings. The scope of the present disclosure will become more fully apparent from the following claims. It is understood that the present invention illustrates only certain embodiments and should not be construed as limiting the scope thereof. The present disclosure will be described with additional specificity and detail through the use of the accompanying drawings, in which: In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. Unless otherwise indicated, similar symbols typically identify similar components. The illustrative embodiments described in the description, drawings, and claims are not intended to be limiting. Other embodiments may be utilized, and other variations may be made, of the subject matter presented herein. Aspects of the present disclosure are generally as described herein. and as shown in the drawings, may be arranged, permuted, and combined in a wide variety of different configurations. and designs, all of which are expressly contemplated and made part of this disclosure. It will be easily understood that. [Figure 1] FIG. 1 is a schematic diagram of a mechanical circulatory support (MCS) device. [Figure 2A] FIG. 2A is a schematic diagram of a cutaway view of a portion of an MCS device. [Figure 2B] FIG. 2B is a cross section of the distal impeller region of FIG. 2A. [Figure 2C] FIG. 2C is a cross section of the outflow region of FIG. 2A. [Figure 3] FIG. 3 is a schematic diagram of an MCS device with a constant radial gap in the distal impeller region and in the outflow region. [Figure 4] FIG. 4 is a schematic diagram of an MCS device with minimized radial gap in the distal impeller region and a larger radial gap in the outflow region. [Figure 5] FIG. 5 is a schematic diagram of an MCS device with a minimized radial gap in the distal impeller region and a larger radial gap in the outlet region with an angled transition. [Figure 6] FIG. 6 is a schematic diagram of an MCS device having an impeller with a constant diameter and an insertion sleeve to minimize the radial gap in the distal impeller region. [Figure 7] FIG. 7 is a schematic diagram of an MCS device having an impeller with impeller blades in the distal impeller region and no impeller blades in the outlet region. [Figure 8]FIG. 8 is a schematic diagram of an MCS device having an impeller with impeller blades in the distal impeller region and a conical shape in the outlet region connected to the impeller. [Figure 9] FIG. 9 is a schematic diagram of an MCS device having impeller blades in the distal impeller region and an impeller with a conical shape in the outflow region that remains stationary relative to the motor housing and tubular cannula. [Figure 10] FIG. 10 is a schematic diagram of an MCS device having an impeller with a tapered distal portion. [Figure 11] FIG. 11 is a schematic diagram of an MCS device having an impeller with a tapered distal portion and a proximal narrowed portion. [Figure 12A] FIG. 12A is a schematic diagram of an MCS device having a variable radial gap between the impeller and the surrounding cannula or impeller housing and having a driving magnetic rotor. [Figure 12B] FIG. 12B is an enlarged view of a portion of FIG. 12A. DETAILED DESCRIPTION OF THE INVENTION

[0066] The disclosure herein provides a method for transferring blood while minimizing the risk of damage to the device or the blood. In particular, the present disclosure relates to mechanical circulatory assist devices having features that can optimize their ability to function. , the characteristics of impellers or components that are intended to rotate, as well as those that remain stationary their relationship to the tubular inflow cannula or components intended for the flow of The following detailed description is directed to a specific embodiment. , referring to the drawings, and for purposes of clarity, like parts or steps are designated by like numerals throughout. In this specification, "one embodiment," "an embodiment," or A reference to "in some embodiments" refers to a specific feature, structure, or combination of features that are described in connection with an embodiment. or feature is meant to be included in at least one embodiment of the present invention. In various places in this document, the terms "in one embodiment," "one embodiment," or "in some embodiments" appear to refer to Appearances of the phrase "is" do not necessarily all refer to the same embodiment and may refer to separate or distinct embodiments. Furthermore, alternative embodiments are not necessarily mutually exclusive of other embodiments. Various features are described that are exhibited by some embodiments and not by others. Similarly, some aspects may be required in some embodiments but not in others. Various possible requirements are described. Now, embodiments of the present invention will be described in detail. Examples of which are illustrated in the accompanying drawings.

[0067] As shown in FIG. 1, the mechanical circulatory support (MCS) device has a proximal end 25 and a distal end 26. an inlet tube or tubular inflow cannula 4 having an inflow region 5 at its distal end and an outflow region 6 at its proximal end; and for driving an impeller 2 positioned at least partially within the tubular cannula. The rotating impeller drives the blood through the inlet region 5 and into the stationary inlet column. 4 and forcing blood out of the device at least partially through the outflow region 6. .

[0068] FIG. 2A is an enlarged cutaway view of a portion of the MCS device of FIG. 1. The outlet region 6 is A strut 8 may be included that connects the oral cannula 4 to the motor housing 9. For example, the MCS device may have at least two struts 8 (e.g., three, four, five struts). 6 has a tubular cannula opening or window 7 defined by struts 8. The inner or outer edges or cut surfaces of the opening 7 may be rounded (e.g., 0 The diameter of the curve is equal to the thickness of the tubular inflow cannula, which can range from 0.10 to 0.15 mm. There is a very small gap between the outer edge of the impeller blades 3 and the inner surface of the tubular inflow cannula 4. The rotating edges of the impeller blades 3 are subject to mechanical wear and abrasion. friction, loss of impeller speed, increased motor drag, heat generation, or other undesirable effects. To avoid any adverse effects, the tubular cannula 4 must not come into contact with the between the impeller blades 3 and the inner surface of the cannula 4 to maximize the flow rate and reduce hemolysis. It may be advantageous to have a minimum radial gap 1a at the Hemolysis is a form of blood damage that can be caused by hydraulic shear stresses that are generated by the damaged blood. Hemolysis may be characterized by hemoglobin, and a measure of hemolysis is the amount of hemoglobin in a blood sample. It contains the hemolytic damage potential (HDP), which corresponds to the ratio of free hemoglobin to the total volume of the vial. The amount of hemolysis may depend on several factors, one of which may be the impeller speed. Thus, generally speaking, the higher the efficiency or flow rate produced by a given impeller speed, the better. , the flow rate can be increased while minimizing hemolysis. This may include minimizing reflow, a factor that affects efficiency. The radial gap 1a between the impeller blades and the inner surface of the tubular cannula 4 is small. The smaller the flow rate, the higher the flow rate achieved against the potential for hemolytic damage, helping to generate sufficient flow. This is because the impeller blades are tubular. The distal impeller region 11 rotates on the rigid portion of the tube 4, and is located in the distal region of the outflow region 6. No laser cutting is applied to increase stiffness, and minimal radial Except for the cap, blood flows through the space defined by the inner surface of the tubular cannula and the impeller. The fluid must flow at a sufficient rate into the confined space defined by the tubular cannula. The helical pitch of the rotating impeller blades in the space causes blood to flow into the distal impeller region 11 6 towards the outflow area 6. The blood displacement is A pressure differential is created that draws blood into the inflow region 5 of the tubular cannula 4 .

[0069] In the outflow region 6, rotating impeller blades direct blood flow through the outflow window 7. The needle 4 is in an outflow area 6 having an outflow opening or window 7 defined by struts 8. , minimizing the radial gap 1b between the impeller blade 3 and the inner surface of the support 8 is generated in the distal impeller region 1 due to flow disturbances that arise as a result of the interaction between the blood flow and the struts 8. In some embodiments, the lamination of the outflow region 6 may not contribute much to the efficiency compared to the lamination of the outflow region 6. Minimizing the radial gap 1b is, in part, due to the The hydraulic shear stress applied to the blood cells in space 1b may cause undesirable hemolytic damage. Furthermore, minimizing the radial gap 1b can reduce the braking force during use. Challenges with very small manufacturing tolerances that can increase the risk of contact between the rod and the support This can cause material wear, increased motor current, heat production, or other equipment damage. This can result in increased scarring and hemolysis. Therefore, aspects of the present disclosure provide impeller blades and the inner surface of the tubular cannula of the distal impeller region 11. Design of MCS equipment in which is minimized (for example, in the range of 0.04 mm to 0.5 mm) Regarding the second radial gap 1b between the impeller blade and the inner surface of the support 8, The first radial gap is larger than the first radial gap (in the range of 0.04mm to 3mm). cap), reducing the risk of damaging the blood or the device itself during use and improving efficiency. Can be optimized.

[0070] One way to increase the second radial gap 1b is to increase the inner diameter of the tubular cannula. while maintaining the outflow area compared to the diameter of the impeller blades in the distal impeller region 11. The first approach is to reduce the diameter of the impeller blades. The larger the gap 1b, the smaller the diameter of the impeller blades in the outflow region. The impeller has a first radius 27 in the outlet region 11 and a second radius 28 in the outlet region 6. 2B is a cross-sectional view of FIG. 2A at the distal impeller region 11. 2C is a cross-sectional view of FIG. 2A at the outlet region 6. The impeller radius 27 is radius 28, and as a result, radial gap 1a is larger than radial gap 1b. small.

[0071] Figure 3 shows the arrangement of the impellers at constant speed, which may represent some configurations in current MCS installations. 1 is a schematic diagram of a cutaway view of a portion of an MCS device showing an impeller having a diameter. To achieve this, the impeller 2 has at least two spirally inclined impeller blades, the outermost of which is The impeller 2 is depicted as a cylinder with a diameter of 13. The impeller may have impeller blades, which are preferably radially balanced. The rub blade may be substantially helical or may have a varying pitch. The tubular cannula 4 may have an inner diameter 12, e.g., 3.8 mm. Range of 10mm to 6mm (e.g., range of 3.8mm to 5mm, or 4.3mm to 4.5mm) The impeller may have a first diameter 13 at the distal impeller region 11 and an outlet diameter 14 at the outlet. and a second diameter 14 of region 6. In FIG. 3, first diameter 13 and second diameter 14 are Therefore, the first gap 1a and the second gap 1b are equal.

[0072] In contrast to Figure 3, Figure 4 shows the impeller 2 depicted as a cylinder for simplicity, with the distal The impeller has a first diameter 13 in the impeller region 11 and a second diameter 15 in the outlet region 6, The diameter 15 is smaller than the first diameter 13. The resulting first gap 1a is It is minimized for optimal efficiency, for example, in the range of 0.040 mm to 0.200 mm (e.g. , in the range of 0.070 to 0.1 mm, about 0.075 mm), and the second gap 1b is The second gap 1b is larger than the first gap 1a. For example, the second gap 1b is The size of the second gap 1b is in the range of 1 to 50 times (for example, the second gap 1b is in the range of about 0.040 mm to 2 m The first diameter may be in the range of 13 mm, about 0.20 mm. The difference between the first diameter 13 and the second diameter 15 may be about 0.25 mm. The transition 16 between the two may be a step as shown in Figure 4. Alternatively, as shown in Figure 5 For example, the sloped transition 17 may be 0.011 to 0.015. The slope may have a rise vs. run or change in diameter vs. length in the range of 2 (e.g., 1). Additionally, the transition may be curved or have multiple bends (e.g., an S-shaped curve). You may do so.

[0073] An alternative embodiment is shown in FIG. 6, which shows the cutting of the impeller 2 with a constant diameter. The drawing shows that the first diameter 13 of the distal impeller region 11 is perpendicular to the second diameter 14 of the outlet region 6. 1 is a schematic diagram of a portion of an MCS device showing the tubular cannula 4 having a diameter equal to that of the tubular cannula 14. It has a constant outer diameter in the distal impeller region 11 and in the outlet region 6. The sleeve 19 is At least the distal impeller region 11 is inserted into the tubular cannula, but the outflow region 6 is not. The sleeve 19 is intended to remain stationary in use relative to the inlet pipe. The sleeve fits snugly over the inside diameter of the tubular cannula and is optionally glued to form a tight fit. the outer diameter of the first impeller by a distance equal to the gap 1a. The inner diameter is slightly larger than the diameter of the nozzle 13. Since the sleeve 19 is not in the outlet region 6, The gap 1b is determined by the thickness 18 of the sleeve 19, which may be in the range of, for example, 0.04 to 2 mm. Therefore, the gap is larger than gap 1a. Optionally, sleeve 19 is As shown, the distal end has a tapered or beveled proximal end. Optionally, the sleeve 19 is provided with a protective layer to withstand wear when the impeller contacts the sleeve during use. Optionally, the inner surface of the sleeve may be made of a high density polymer such as PEEK. may have a lubricious coating to further reduce hydraulic shear stresses in the blood .

[0074] Another embodiment is shown in FIG. 7 and has impeller blades 3 in the distal impeller region 11. 1 shows a cutaway view of the impeller 2 without impeller blades in the outlet region 6 of the MCS device. 1 is a schematic diagram of a portion of the device. The impeller shaft 10 is The impeller blades 3 may be of rod-shaped configuration, from which the impeller blades 3 extend radially, The shaft 10 passes through the outflow region and may connect to a motor drive shaft or rotor. The first radial gap 1a between the impeller blades 3 and the inner surface of the tubular cannula 4 is , can be in the range of 0.04 mm to 0.5 mm (for example, 0.1 mm), and the second The radial gap 1b is 1.75 m across the distance between the shaft 10 and the inner surface of the support 8. The thickness can be in the range of 1000µm to 3mm.

[0075] Alternatively, as shown in FIG. 8, the shaft 10 may be rod-mounted at the distal impeller region 11. shaped, and then have a conical shape 30 in the outflow region. The shape 30 provides a concave taper that may facilitate directing blood flow through the fenestrations 7 in the outflow region 6. 31. Optionally, the proximal portion of the conical portion of shaft 30 may have a convex curve. 32. A first radial groove between the impeller blade 3 and the inner surface of the tubular cannula 4 The gap 1a may be within the range of 0.04 mm to 0.5 mm (for example, 0.1 mm). The second radial gap 1b is the distance between the conical shaft 30 and the inner surface of the support 8. The gap 1b at the point closest to the support 8 is in the range of 0.04 mm to 2 mm. Optionally, the cone shape 30 may have an electropolished surface.

[0076] Another embodiment is shown in FIG. 9, which has impeller blades 3 in the distal impeller region 11. 1 shows a cutaway view of the impeller 2 without impeller blades in the outlet region 6 of the MCS device. 8. Similar to the device shown in FIG. 8, there is a cone 35 in the outflow area. However, the cone 35 is not rigidly connected to the impeller shaft 10. Instead, the cone 35 is fixed relative to the tubular cannula 4 or the motor housing, For example, the cone 35 may be rigidly connected to the motor housing or tubular cannula. The impeller shaft 10 passes through a cone 35. Optionally, bearings or A seal 36 may be positioned between the impeller shaft 10 and the cone shape 35 . The conical shape may have a concave surface 37 that facilitates directing blood flow through the window 7 . Optionally, the proximal portion of the cone 35 may have a convex surface (not shown). The first radial gap 1a between the blade 3 and the inner surface of the tubular cannula 4 is 0.04 In the outflow region, the diameter may be in the range of 0.5 mm to 0.1 mm (for example, 0.1 mm). The second radial gap between the shape 35 and the inner surface of the strut 8 may be as small as 0. In other words, the cone shape 35 may be connected to the strut 8 at its proximal end, and the cone shape 35 and The distance between the posts 8 may increase distally.

[0077] Another embodiment is shown in FIG. 10, which is a cutaway view of a portion of an MCS device showing the impeller area. For simplicity, the impeller 2 is shown with a contour in the range of the outer diameter of the impeller. These contours are cylindrical and are swept out by a rotating impeller 2. The contour may refer to the geometric reference volume obtained by the maximum diameter of the impeller blade 3. The impeller 2 may have two or more impeller blades 3, and preferably In some embodiments, the impeller 2 is radially balanced. As shown in FIG. 10, the impeller 2 may be mounted on the shaft 10. As shown, the catheter is positioned within a tubular cannula 4 having an outflow region 6 and a distal impeller region 11. In contrast to the other embodiments described herein, at least the distal region 11 The first impeller diameter 13 of the portion is equal to the second impeller diameter 14 of the outlet region 6. In some embodiments, the distal impeller region 11 has a distal tip that tapers distally to the distal end of the region 11. In other words, the distal impeller region 11 may have a tapered portion 21 at a constant The constant diameter portion 22 may include a distally tapered portion 21 located distally of the constant diameter portion 22. 22 extends from the distally tapered portion 21 to a proximal end at least partially within the impeller region 11. It may extend into the outflow region 6 .

[0078] A first radial gap between the impeller 2 and the surrounding tubular structure in the first region is The second region is located proximal to the first region, and the impeller 2 and the surrounding tubular The radial gap between the impeller 2 and the first region may be larger than the radial gap between the impeller 2 and the first region. The first diameter of the impeller 2 in the second region may be smaller than the second diameter of the impeller 2 in the second region. The distal diameter 20 may be smaller than the first diameter 13. As used herein, the terms "diameter," "width," "width of" and "width of" refer to impellers and surrounding structures. ", "gap" and the like are, as mentioned above, the geometrical groups swept away by the rotating impeller 2. The contour of the impeller may be a semi-volume profile, measured relative to the maximum radial outer width of the impeller in that region. It is possible.

[0079] In some embodiments, the diameter of the impeller at the distally tapered portion 21 is Over the length of the extended portion 21, the diameter varies from a maximum at the first diameter 13 to a relatively small distal diameter 2 In some embodiments, the taper of distally tapered portion 21 may be reduced to 0. Contact between the distal aspect of the impeller 2 and the tubular inflow cannula 4 can be prevented. Thus, in some embodiments, the impeller 2 is attached at its proximal end to the drive shaft 10. The tubular inlet crab may be held by a bearing at its distal end. The inlet port 4 can be cantilevered from the motor housing. In this configuration, the tubular inlet port The aneurysm 4 may be slightly deflected, which is the distal impeller compared to the outflow area 6. This may be more pronounced in region 11. Also, if the rotation axes are exactly parallel and the drive shaft There may be very small imperfections in the mounting of the impeller 2 that are aligned with the axis of rotation of the rotor 10. These factors may increase the risk of contact between the impeller 2 and the cannula 4, especially at the distal end of the impeller 2. The dimensions of the distal tapered portion 21 have a negligible effect on flow efficiency. These dimensions may be selected to reduce or eliminate the risk of contact while still having an impact. may depend on the length of the impeller 2 and the inner diameter of the cannula 4.

[0080] In one embodiment of the MCS device, the impeller 2 has a diameter in the range of 7.5 mm to 8.5 mm. (e.g., 7.97 mm) between its proximal and distal ends, and the inlet tube has a length of at least In the region where the impeller 2 is positioned, the range of 4.39 mm to 4.45 mm (for example , about 4.42 mm). The difference between the first diameter 13 and the distal diameter 20 is 0. 0.40mm~0.100mm (e.g., 0.050mm~0.090mm, 0.060mm The first diameter 1 may be in the range of 0.080 mm to 0.070 mm. The distal diameter 3 may be approximately 4.270 mm and the distal diameter 20 may be approximately 4.200 mm. The length of the tapered portion 21 may be about 3 mm. The slope of 1 can be (0.07mm / 2) / 3mm = 0.0117. The resulting radial gap between the rotor 4 and the rotor 2 is, for example, 0.060 to 0.090 mm. the diameter of the portion 22 may be constant in the mm range (e.g., about 0.075 mm), At the distal end of Impeller 2, in the range of 0.095–0.125 mm (e.g., approximately 0.110 mm) The gap may increase to a value of 0.5 mm, and the impeller 2 has a distal diameter 20 .

[0081] Optionally, the distally tapered portion 21 may taper with a linear slope. Alternatively, the diameter reduction may be non-linear, e.g., a concave curve, a convex curve, or a compound curve. .

[0082] Optionally, as shown in FIG. 11, the impeller 2 has a distally tapered portion 21. and a proximal narrowed diameter portion 23 at least partially aligned with the outflow region 6. This embodiment may have a reduced risk of contact between the impeller 2 and the cannula 4. This embodiment may also have the advantage of improving hemolysis in the outflow region 6. The narrowed diameter 15 of the narrowed diameter portion 23 of the impeller 2 is 0.5 mm smaller than the first diameter 13. It may be in a narrower range of 15 mm to 0.35 mm (for example, about 0.25 mm). 2 and the cannula 4, or at least the narrowed diameter portion 23 The outflow strut 8 at (e.g., the location of the narrowed diameter 15) is about 0.20 mm, or From the minimum radial gap in the impeller region 11 (for example, the position of the maximum diameter 13) may be about 0.125 mm larger.

[0083] In some embodiments, the MCS device may have an interface having a different configuration than that shown in FIG. 2A. The impeller has a variable radius between the impeller and the surrounding cannula or impeller housing. For example, FIG. 12A shows a portion of an MCS device including an impeller 2. The distal end of the impeller 2 is supported by a bearing 43 in the tubular flow path. The bearing 43 may be held axially centered on the inlet cannula or impeller housing 4. The impeller may have spokes that connect to the cannula or impeller housing 4, 2. The impeller 2 maintains its position relative to the impeller or impeller housing 4. The risk of the distal end of the cannula contacting the cannula or impeller housing 4 is reduced or eliminated. In some embodiments, this configuration may be used to reduce hemolysis by increasing the amount of oxygen in the outlet region 6. The MCS device benefits from a reduced impeller diameter. a first radial gap in the outlet region 6 and a second radial gap at least partially in the outlet region 6; The second radial gap may be, for example, as described in other embodiments herein. The first radial gap is larger than the first radial gap, as described in The second radial gap may be about 0.075 mm, and the second radial gap may be about 0.200 mm. In some embodiments, the second radial gap is 2 to 3 times the first radial gap. The gap may be within the range of the gap.

[0084] The impeller 2 is connected to the motor 9 using a non-contact magnetic coupling as shown in FIG. To achieve the magnetic coupling, the impeller 2 is connected to the drive of the motor 9. A drive magnetic rotor 42 is coupled to the drive magnetic rotor 42, which surrounds a shaft-mounted second magnetic rotor 44. Example embodiments of such configurations are described in International PCT Publication No. 2019 / 219874, No. 2019 / 219883, No. 2020 / 011795, No. 2020 / 011797 Nos. 2020 / 030700, 2020 / 064911, and the pending U.S. Provisional Patent Application. No. 63 / 116,616, which is incorporated herein by reference in its entirety. The driving magnetic rotor 42 is arranged in the outlet region 6 to rotate the impeller blades 3. In some embodiments, the cannula or impeller may be positioned with the The impeller housing 4 surrounding the impeller 2 may have a constant inner diameter. The magnetic rotor 42 may have a second diameter 41 that is smaller than the first diameter 41. 40, which forms a second radial gap around the drive magnetic rotor 42. a first radial gap 1a around the impeller 2 (e.g., 0.06 5 to 0.150 mm, approximately 0.070 mm to 0.110 mm, or approximately 0.075 mm 12A) is obtained, which is shown in FIG. 12B, which is an enlarged view of a portion of FIG. 12A. As shown in FIG. 12A, the first diameter 4 The first diameter 1 may be located in the distal impeller region (11), and the second diameter 40 may be located in the outflow region. For example, the impeller blades may be positioned within the first impeller region 11. The maximum outer diameter of the outlet region 6 changes from the first diameter 41 to the second diameter 40 at least partially. and / or the impeller blades may have a diameter equal to the first diameter 41 of the distal impeller region 11. The impeller 2 may have a new maximum outer diameter, and the impeller 2 may be at least partially located in the outlet region 6. The magnetic coupling 42 may include a magnetic coupling having a maximum outer diameter equal to the second diameter 40 .

[0085] While the above description provides examples of one or more processes or devices, other processes may be used. It will be understood that other devices may fall within the scope of the appended claims.

[0086] The specific embodiments described herein are not intended to limit the scope of any claims. and any claims are not intended to be construed as limiting the scope of the invention as set forth below unless expressly indicated otherwise. The claims may encompass different processes or apparatuses than those specifically indicated. Unless otherwise specified, an apparatus having all of the features of any one of the apparatus or processes described below or process, or features common to more than one or all of the devices described below. No device or process described below is or will be limited to any part of this patent application unless the device or process is discontinued at the time of publication. This does not imply any exclusive rights granted by the present invention. Subject matter to which no exclusive rights are granted by the issuance of a patent application is, for example, pending patent applications. The applicant, inventor or owner hereby grants the right to use the invention in any way that is not in accordance with the provisions of this patent. It is not intended that disclosure herein be a waiver, abdication, or public dedication of such subject matter.

[0087] Various modifications to the implementations described in this disclosure will be readily apparent to those skilled in the art and will be readily apparent to those skilled in the art. The general principles defined herein may be applied to other implementations without departing from the spirit or scope of this disclosure. Therefore, the present disclosure should not be construed as being limited to the implementations shown herein. The claims, principles and novel features disclosed herein are not intended to be limiting. The broadest range consistent with the present invention should be given. "serving as an example, instance, or illustration." Any implementation described in this document as an "embodiment" does not necessarily refer to other implementations unless otherwise specified. It should not be construed as preferred or advantageous over any other design.

[0088] Certain features that are described in this specification in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation may also be implemented in multiple implementations. The features may be implemented separately or in any suitable subcombination. , which were described above as acting in a particular combination and were originally claimed as such. However, one or more features from a claimed combination may, in some cases, be used in combination with other features of the claimed combination. The claimed combination is removed from the combination and becomes a subcombination or sub-combination. It may be directed to combination variations.

[0089] Similarly, although operations are illustrated in the figures in a particular order, this is not intended to be a general indication of the order in which operations are performed to achieve a desired result. In order to It should be understood that this does not require that all operations illustrated be performed. Additionally, other implementations are within the scope of the following claims. The actions recited in the claims may be performed in a different order and still be desirable. Better results can be achieved.

[0090] In general, the terms used herein are generally intended as "open" terms. Those skilled in the art will understand that (for example, the term "including" "including but not limited to" should be interpreted as "having" should be interpreted as "having at least" and "includes" should be interpreted as (The term "includes" should be interpreted as "without limitation" or "not limited to"). If specific numerals in the recitation of a claim are intended, such intention shall be construed as including the numerals in the claim. If there is no such statement, it is assumed that no such intention exists. As will be further understood by those skilled in the art, for example, the following attached document may be used as an aid to understanding: The claims are introduced by the introductory phrase "at least one" and "one or more." However, the use of such phrases may be used without the indefinite article. The introduction of a claim by "a" or "an" does not mean that the same claim is Inclusion of words such as "one or more" or "at least one" and "a" or "an" Indefinite articles (e.g., "a" and / or "an" usually mean "at least one" or (which shall be interpreted to mean "one or more"), Any particular claim containing an entered claim statement is It should not be construed as implying a limitation to only one embodiment. The same applies to the use of definite articles used to introduce the claims. Furthermore, even if specific numbers in the introduced claim recitation are explicitly recited, Those skilled in the art will understand that such a description typically means at least the number described. (e.g., "two statements" without other qualifiers) (The mere mention of something usually means at least two mentions, or more than two mentions). Furthermore, if a convention similar to "at least one of A, B, and C, etc." is used, In general, such interpretation is intended in the sense that a person skilled in the art would understand the practice (e.g., For example, "a system having at least one of A, B, and C" means that A alone and B alone alone, C alone, A and B together, A and C together, B and C together, and and / or systems having A, B, and C together. (Not applicable). A convention similar to "at least one of A, B, or C, etc." is used. In general, such interpretation is intended in the sense that a person skilled in the art would understand the practice ( For example, "a system having at least one of A, B, or C" means that A alone B alone, C alone, A and B together, A and C together, B and C together, and / or a system having A, B, and C together, etc. (Not applicable to the present invention.) Two or more alternative embodiments may be presented in either the description, claims, or drawings. Virtually any disjunction and / or phrase presenting a term may be used to refer to one of the terms, It should be understood that the possibility of including either or both terms is contemplated. It will be further understood by those skilled in the art that, for example, the phrase "A or B" should be interpreted as "A " or "B," or "A and B."

Claims

[Claim 1] 1. A mechanical circulatory assist device, comprising: A tubular cannula comprising an inflow region (5), an outflow region (6), and a distal impeller region (11). - (4) and An impeller (2) having a proximal end and a distal end, said impeller (2) comprising at least also partly within the outflow region (6) and at least partly within the distal impeller region ( an impeller (2) positioned within said tubular cannula (4) in a nozzle hole (11); The impeller (2) is coupled to the driving magnetic rotor (42). 2) and The radial gap between the impeller (4) and the inner surface of the tubular cannula (4) is The size varies between the proximal end and the distal end, and the characteristic The size of the radial gap at a particular position is equal to or larger than the maximum impeller width at the particular position. and the inner surface of the tubular cannula (4). Device.

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