Balloon catheter blood pump implanted into aorta abdominalis

Abstract

The balloon catheter blood pump comprises a pump body, a flow guide cone, a tail sleeve, a five-cavity catheter, a balloon and an impeller rotor assembly, the pump body comprises an inflow cage, a middle section and an outflow cage, the outflow cage end of the pump body is connected with the flow guide cone, the flow guide cone is connected with the tail sleeve, the tail sleeve is connected with the five-cavity catheter, and the five-cavity catheter is connected with the impeller rotor assembly. The two ends of the balloon are fixed to the middle section of the pump body in a sleeved mode, five round holes are formed in the cross section of the five-cavity catheter and include two flushing fluid perfusion holes, a wiring hole, a balloon injection hole and a center hole, the impeller rotor assembly comprises an impeller, an impeller shaft, a bearing and a flexible transmission shaft, and the impeller is installed at the far end of the impeller shaft and arranged in the pump body. A bearing is arranged between the impeller shaft and the inner wall of the flow guide cone, the near end of the impeller shaft is connected with the far end of a flexible transmission shaft, the flexible transmission shaft penetrates through the center hole, a gap a is reserved between the impeller shaft and the flow guide cone in the radial direction, and a gap b communicated with the gap a is reserved between the impeller and the flow guide cone in the axial direction.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical instrument technical field more specifically, relate to a kind of balloon catheter blood pump implanted in abdominal aorta. BACKGROUND

[0002] Acute decompensated heart failure (ADHF) is a common clinical syndrome with poor prognosis, and most ADHF patients need to be hospitalized for further treatment. In China, ADHF is the main reason for hospitalization of patients over 65 years old, with a hospital mortality rate of 3% and a short-term readmission rate of about 50%. Although the use of guideline-directed drug therapy can reduce mortality and reduce heart failure hospitalization, studies are mainly limited to stable ADHF patients or chronic heart failure patients without NYHA functional class IV symptoms. So far, the sustained improvement in morbidity and mortality of ADHF patients has not been proven by the application of standard drug therapy (including adjustment of dose of diuretics and inotropic drugs), new drugs (such as nesiritide, tolvaptan and saralasin) or device-based methods (such as aortic balloon counterpulsation pump).

[0003] Patent US20220257920A1 discloses a blood pump comprising a motor, an impeller, a pump body and a elastic support provided on the pump body, which can provide short-term and medium-term mechanical circulation support for ADHF patients. The elastic support is made of metal laser cutting, and there is a risk of scratching the inner wall of the blood vessel during the implantation and release of the blood pump. And when the blood pump is working, a part of the blood will leak between the blood pump and the blood vessel, so that it cannot provide greater flow and pressure rise. UTILITY MODEL CONTENT

[0004] The utility model aims at providing a kind of balloon catheter blood pump implanted in abdominal aorta, which can reduce the damage of blood pump to the inner wall tissue of aorta and improve blood pressure rise and flow.

[0005] To achieve the above-mentioned purpose, the utility model adopts the following technical solutions:

[0006] The invention relates to a balloon catheter blood pump implanted in abdominal aorta, which comprises a pump body, a flow cone, a tail sleeve, a five-cavity catheter, a balloon and an impeller rotor assembly, the pump body comprises an inflow cage, an intermediate section and an outflow cage, the outflow cage end of the pump body is connected with the flow cone, the flow cone is connected with the tail sleeve, the tail sleeve is connected with the five-cavity catheter, the two ends of the balloon are fixed to the intermediate section of the pump body, the cross section of the five-cavity catheter is provided with five circular holes, which are two irrigation liquid perfusion holes, a wire hole, a balloon injection hole and a central hole, the impeller rotor assembly comprises an impeller, an impeller shaft, a bearing and a flexible transmission shaft, the impeller is installed at the distal end of the impeller shaft and placed in the pump body, the bearing is arranged between the impeller shaft and the inner wall of the flow cone, the proximal end of the impeller shaft is connected with the distal end of the flexible transmission shaft, the flexible transmission shaft penetrates through the central hole, the impeller shaft and the flow cone are radially spaced apart by a gap a, the impeller and the flow cone are axially spaced apart by a gap b which is communicated with the gap a, the two irrigation liquid perfusion holes are communicated with the gap a so as to flush a small amount of blood stagnating in the gaps a and b along the perfusion direction, a micro pressure measuring element is led out from the wire hole of the five-cavity catheter and placed on the outer wall surface of the flow cone, and a balloon injection tube is led out from the balloon injection hole of the five-cavity catheter and placed on the outer wall surface of the pump body and communicated with the balloon.

[0007] The maximum diameters of the pump body, the flow cone and the tail sleeve are equal, and the outer contour of the balloon catheter blood pump is smoothly connected.

[0008] The wire hole and the balloon injection hole are 5-6 mm smaller than the total length of the five-cavity catheter along the axial length, and side holes for leading out the micro pressure measuring element and the balloon injection tube are arranged on the surface of the five-cavity catheter.

[0009] The flow cone comprises a cylindrical section and a necked section at the distal end of the cylindrical section, the surface of the cylindrical section is provided with two grooves, the cross sections of the grooves are square and semicircular respectively, the square groove is 0.8-1.2 mm in length along the axial direction of the proximal end surface, and the semicircular groove penetrates through the cylindrical section along the axial direction, the square groove and the semicircular groove are arranged symmetrically on the surface of the cylindrical section.

[0010] The outer wall surface of the necked section is a blood flow guiding surface which is connected with a flat wall surface, two arc wall surfaces in sequence, the flat wall surface is arranged at the distal end of the cylindrical section and has a diameter smaller than that of the cylindrical section.

[0011] The surface of the tail sleeve is provided with two transition grooves arranged along the axial direction, the cross section sizes and the circumferential positions of the two transition grooves correspond to the square groove and the semicircular groove respectively, the micro pressure measuring element and the balloon injection tube are respectively close to the transition grooves of the tail sleeve and the square groove and the semicircular groove of the flow cone.

[0012] The central hole is coaxially arranged with the five-cavity catheter, and the wall thickness between the central hole and the other four small holes needs to be at least 0.2 mm.

[0013] The inflow cage is a plurality of spaced inflow holes opened in the upper sidewall of the pump body, the outflow cage is a plurality of spaced outflow holes opened in the lower sidewall of the pump body, and the inflow holes and the outflow holes are all semi-elliptical; the inflow cage is circularly arc-contracted along the distal axial direction.

[0014] The balloon injection tube should extend to the outer surface of the middle section along the rib between the proximal outflow holes on the pump body; wherein the diameter of the balloon injection tube is not greater than the width of the rib.

[0015] The maximum diameter of the balloon after expansion ranges from 28 to 35 mm, and the material is preferably PA12.

[0016] The utility model discloses a balloon catheter blood pump implanted in the abdominal aorta, which can replace the elastic stent of the previous abdominal aorta blood pump, form soft contact with the inner wall of the blood vessel, reduce the damage of the metal elastic stent to the blood vessel tissue, and improve the organ perfusion effect of each branch of the abdominal aorta. BRIEF DESCRIPTION OF DRAWINGS

[0017] In order to more clearly illustrate the embodiments of the utility model, the embodiments will be described below with reference to the drawings.

[0018] Figure 1 is the structure schematic view of the balloon catheter blood pump implanted in the abdominal aorta in the utility model;

[0019] Figure 2 is the appearance structure schematic view of the balloon catheter blood pump;

[0020] Figure 3 is the structure schematic view of the flow guide cone;

[0021] Figure 4 is the cross-sectional structure schematic view of the flow guide cone;

[0022] Figure 5 is the cross-sectional structure schematic view of the tail sleeve;

[0023] Figure 6 is Figure 1 is the local structure enlarged schematic view of I in the utility model;

[0024] Figure 7 is the schematic view of the cross section of the five-cavity catheter;

[0025] Figure 8 isFigure 1 Partial enlarged view of the micro pressure sensor and the balloon inflation tube at II;

[0026] Figure 9 is a structural schematic view of the pump body;

[0027] Figure 10 is Figure 1 Enlarged view of the flow path of the flushing liquid flushing the gap between the impeller and the guide cone at III;

[0028] Figure 11 is a top view of the balloon catheter blood pump. DETAILED DESCRIPTION

[0029] The following will only illustrate possible implementation manners of the present application by way of examples, but are not intended to limit the scope of the present application which is intended to be protected, and it is hereby stated in advance.

[0030] The present application will be described in detail hereinafter with reference to the drawings. When the following description refers to the drawings, the same numbers in different drawings represent the same or similar structures unless otherwise specified. In the present application, the terms "proximal end" and "distal end" are relative to the operator of the balloon catheter blood pump, the direction close to the operator is defined as "proximal end", and the direction away from the operator is defined as "distal end".

[0031] Referring to Figure 1 As shown, the balloon catheter blood pump 1 is implanted in the abdominal aorta 2, driven by an extracorporeal motor through a flexible transmission shaft 19, and the torque is transmitted to the impeller 16 through the impeller shaft 17, so that the impeller 16 rotates at high speed to do work on the blood, converting mechanical energy into pressure potential energy to raise the blood pressure of the abdominal aorta 2. Among them, the blood flows from the distal end into the pump body of the balloon catheter blood pump 1 and flows out from the proximal end of the pump body. In combination Figure 1 、 Figure 2 and Figure 9As shown, the static part of the balloon catheter blood pump mainly includes a pump body 11, a flow cone 12, a tail sleeve 13, a five-cavity catheter 14, and a balloon 15, and the dynamic part is an impeller rotor assembly. The pump body 11 includes an inflow cage 111, an intermediate section 112, and an outflow cage 113. The outflow cage end of the pump body 11 is connected to the flow cone 12. The flow cone 12 is connected to the tail sleeve 13. The tail sleeve 13 is connected to the five-cavity catheter 14. The two ends of the balloon 15 are fixed to the intermediate section 112 of the pump body 11. The cross section of the five-cavity catheter 14 is provided with five circular holes, which are two irrigation liquid perfusion holes A1 and A2, a wire hole B, a balloon injection hole C, and a central hole D. The impeller rotor assembly includes an impeller 16, an impeller shaft 17, a bearing 18, and a flexible transmission shaft 19. The impeller 19 is installed at the distal end of the impeller shaft 17 and is placed in the pump body 11. Two bearings 18 are arranged between the impeller shaft 17 and the inner wall of the flow cone 12. The proximal end of the impeller shaft 17 is connected to the distal end of the flexible transmission shaft 19. The flexible transmission shaft 19 penetrates the central hole D. The impeller shaft and the flow cone have a radial direction gap a. The impeller and the flow cone have an axial direction gap b which is communicated with the gap a. The two irrigation liquid perfusion holes are communicated with the gap a, so as to make a small amount of blood in the gaps a and b stagnant along the perfusion direction. A micro pressure measuring element is led out from the wire hole of the five-cavity catheter and placed on the outer wall surface of the flow cone. A balloon injection tube is led out from the balloon injection hole of the five-cavity catheter and placed on the outer wall surface of the pump body to communicate with the balloon.

[0032] The two ends of the balloon 15 are fixed to the outer wall surface of the pump body 11. The fixing mode is preferably biological compatibility glue bonding. The cross section of the balloon 15 after inflation is in the shape of “Ω”. The maximum diameter D of the inflated balloon 15 ranges from 28 mm to 35 mm, and can be in close contact with the inner wall surface of the abdominal aorta 2, so as to reduce the leakage of blood from the gap between the balloon 15 and the inner wall of the abdominal aorta 2, and force more blood to flow into the pump body 11. The flow cone includes a cylindrical section and a necked section at the distal end of the cylindrical section. The surface of the cylindrical section is provided with two grooves. The cross sections of the grooves are square and semicircular respectively. The length of the square groove along the axial direction of the proximal end surface is 0.8-1.2 mm. The semicircular groove penetrates the cylindrical section along the axial direction. The square groove and the semicircular groove are symmetrically arranged on the surface of the cylindrical section.

[0033] Referring to Figure 3 As shown, the flow cone 12 includes a cylindrical section 121 and a necked section at the distal end of the cylindrical section. The cylindrical section and the necked section form an annular end surface 122. The necked section is inserted into the pump body. The annular end surface 122 is used to connect the pump body 11. The free end of the necked section is provided with an end surface 123. Figure 4As shown, the cylindrical section 121 of the flow cone 12 is provided with two grooves, namely a square groove 124 and a semicircular groove 125. The square groove 124 has a length of 0.8-1.2 mm along the axial direction, while the semicircular groove 125 penetrates the cylindrical section 121 along the axial direction until the annular end face 122. The square groove 124 has a depth of 0.2-0.5 mm along the radial direction, while the semicircular groove 125 has a depth of 0.25-0.45 mm along the radial direction, which is slightly greater than the depth of the square groove 124. In addition, the square groove 124 and the semicircular groove 125 are preferably arranged symmetrically at the center of the cylindrical section 121. The annular end face 122 and the end face 123 are connected by three blood flow guiding wall surfaces, i.e., a flat wall surface 1231, an arc wall surface 1232, and an arc wall surface 1233 in sequence. The three blood flow guiding wall surfaces are tangent to each other, thereby ensuring smooth blood flow. A stepped surface 126 is provided in the flow cone 12 for positioning and mounting the bearing 18.

[0034] Referring to Figure 5 As shown, the tail sleeve 13 is provided with two transition grooves 131 and 132, and each of the transition grooves 131 and 132 is provided with a circular arc corner 1311 and 1321 at the starting position near the end. The two transition grooves 131 and 132 penetrate the tail sleeve 13 along the axial direction until the end face 134. In combination Figure 4 As shown, the tail sleeve 13 is connected with the inner wall surface 127 of the flow cone 12 through the connecting surface 133, so that the end face 134 is tightly attached to the flow cone 12. The cross-sectional size and circumferential position of the transition grooves 131 and 132 need to be consistent with the square groove 124 and the semicircular groove 125 respectively, so that the outer surface of the tail sleeve 13 can smoothly transition to the outer surface of the flow cone 12 without any obstruction or misalignment. A stepped surface 136 is provided inside the tail sleeve 13, and a circular arc corner 135 is provided at the corner of the stepped surface 136 for transition connection.

[0035] Referring to Figure 6 As shown, the bearing 18 is selected as a standard part, which can be a radial bearing or a thrust bearing, for limiting the radial and axial movement of the impeller 16, and the number of bearings is generally 2. The impeller shaft 17 is mainly a cylindrical body with a larger middle diameter than the diameters of both ends. The outer ring of the bearing 18 at the distal end abuts against the stepped surface 126, and the inner ring abuts against the impeller shaft end face 171. Similarly, the inner ring of the bearing 18 at the proximal end abuts against the impeller shaft end face 171, and the outer ring abuts against the end face of the tail sleeve 13. It should be noted that the impeller shaft end face 171 cannot exceed the innermost side of the outer ring of the bearing 18, and the innermost side of the stepped surface 126 and the tail sleeve 13 cannot exceed the outermost side of the inner ring of the bearing 18. The impeller shaft 17 and the bearing 18 are tightly connected, the bearing 18 is gap-connected with the flow cone 12 and is fixed by biocompatible glue.

[0036] Referring to Figure 7As shown, the cross section of the five-lumen catheter 14 is provided with five circular holes, namely the perfusion holes A1 and A2 of the flushing liquid, the wire hole B, the balloon injection hole C, and the central hole D. The length of the five-lumen catheter 14 is set to be 1.0-1.5 m, and the outer wall diameter of the catheter is set to be 2.6-3.3 mm. The central hole D is coaxially arranged with the five-lumen catheter 14, and the diameter is 0.1-0.2 mm larger than that of the transmission flexible shaft 19. The perfusion holes A1 and A2 of the flushing liquid are radially symmetrically arranged, and the diameter range is set to be 0.3-0.6 mm. The lengths of the perfusion holes A1 and A2 of the flushing liquid and the central hole D are all the total length of the five-lumen catheter 14, i.e. penetrating through the entire catheter. The diameter range of the wire hole B is set to be 0.2-0.4 mm, and the diameter range of the balloon injection hole C is set to be 0.4-0.6 mm. Similarly, the wire hole B and the balloon injection hole C are radially symmetrically arranged. In addition, the wall thickness between the central hole D and the other four small holes needs to be at least 0.2 mm, preventing the transmission flexible shaft 19 from being rubbed with the catheter to cause a penetration risk. The material of the five-lumen catheter 14 can be selected from high-molecular elastomer materials such as PVC, TPU, or Pebax, which have good biocompatibility. Figure 8 As shown, the wire hole B and the balloon injection hole C are to be smaller than the total length of the catheter by 5-6 mm along the axial length, i.e. not completely penetrating through the five-lumen catheter 14. The wire hole B and the balloon injection hole C are both provided with side holes at the distal end of the catheter, namely the side holes 1412 and 1422. Referring to Figure 8 As shown, the micro pressure measuring element 141 and the balloon perfusion tube 142 are respectively led out from the side holes 1412 and 1422, and are sequentially smoothly transitioned to the surface of the flow cone 12 and the pump body 11 through the five-lumen catheter 14 and the tail sleeve 13. Referring to Figure 2 、 Figure 4 、 Figure 5 and Figure 8 As shown, the micro pressure measuring element 141 and the balloon injection tube 142 need to be closely attached to the transition grooves 131 and 132 of the tail sleeve 13 and the square groove 124 and the semicircular groove 125 of the flow cone 12. In order to ensure the position fixation of the micro pressure measuring element 141 and the balloon injection tube 142, biocompatible glue needs to be filled and adhesively fixed between the micro pressure measuring element 141, the balloon injection tube 142, and the pump body 11, the flow cone 12, the tail sleeve 13, and the five-lumen catheter 14 of the balloon catheter blood pump 1; especially in the reserved spaces 1411 and 1421 of the side holes, biocompatible glue is filled and solidified to prevent the wire of the micro pressure measuring element 141 or the balloon injection tube 142 from being broken or kinked. The probe of the micro pressure measuring element 141 needs to be placed in the square groove 124 and is also adhesively fixed by using glue.

[0037] Referring to Figure 9As shown, the inflow cage 111, the middle section 112 and the outflow cage 113 of the pump body 11 are preferably integrally machined. The inflow cage 111 is composed of a plurality of ribs 1111, the number of which is generally 3-6, and encloses a plurality of inflow holes 1112 in the circumferential and axial directions. As shown, Figure 1 and Figure 9 As shown, the ribs 1111 are arc-contracted in the distal axial direction, which can help the blood flow in and reduce the generation of vortex. The outflow cage 113 is also composed of a plurality of ribs 1131, the number of which can be equal to or different from that of the ribs 1111 of the inflow cage 111. However, the ribs 1131 need to be parallel to the axial direction of the pump body 11 and connected to the annular end face 122 at the proximal end. The inflow and outflow holes in the inflow cage 111 and the outflow cage 113 are approximately semi-elliptical, with straight edges near the middle of the pump body 11 and arc-shaped edges on the opposite sides. Meanwhile, each of the ribs 1111 and the ribs 1131 is provided with an arc corner to reduce the degree of mechanical damage to the blood. A notch 114 is provided at the proximal end of the pump body 11, which is intended to allow the balloon inflation tube 142 to be arranged closely to the outer surface of the pump body 11.

[0038] As shown, Figure 10 The gap a between the impeller shaft 17 and the flow guide cone 12 in the radial direction is 5-10 μm, and the gap b between the impeller 16 and the flow guide cone 12 in the axial direction is 20-100 μm. The flushing fluid flushes the small amount of blood stagnating in the gaps a and b in the perfusion direction 1261, thereby reducing the probability of thrombosis. The arc surface 1233 of the flow guide cone 12 needs to be tangent to the tail cone surface 161 of the impeller 16, so that the blood flows out of the pump body 11 smoothly after being worked by the impeller 16.

[0039] As shown, Figure 11 The balloon inflation tube 142 should extend along the proximal ribs 1131 to the outer surface of the middle section 112 of the pump body 11. The diameter of the balloon inflation tube 142 is not greater than the width of the ribs 1131. As shown, Figure 1 In order to inflate the balloon 15 to the required diameter, the perfusion fluid can be a liquid or a gas, such as physiological saline, glucose or helium, etc. The pressure range of the inflation is 200-400 mmHg. The material of the balloon 15 needs to meet the requirements of biocompatibility and certain ductility, which can be TPU, PA12 or other high polymer materials.

[0040] The blood pump can provide greater blood flow, pressure rise and no risk of damage to the inner wall of the blood vessel.

Claims

1. A balloon catheter blood pump for implantation in the abdominal aorta, characterized in that The pump body includes an inflow cage, an intermediate section, and an outflow cage, the outflow cage end of the pump body is connected to the flow cone, the flow cone is connected to the tail sleeve, the tail sleeve is connected to the five-cavity catheter, both ends of the balloon are fixed to the intermediate section of the pump body, the cross section of the five-cavity catheter is provided with five circular holes, which are two irrigation liquid perfusion holes, a wire hole, a balloon injection hole, and a central hole, the impeller rotor assembly includes an impeller, an impeller shaft, a bearing, and a flexible transmission shaft, the impeller is installed at the distal end of the impeller shaft and placed in the pump body, the bearing is arranged between the impeller shaft and the inner wall of the flow cone, the proximal end of the impeller shaft is connected to the distal end of the flexible transmission shaft, the flexible transmission shaft penetrates through the central hole, the impeller shaft and the flow cone are radially spaced apart by a gap a, the impeller and the flow cone are axially spaced apart by a gap b which is communicated with the gap a, the two irrigation liquid perfusion holes are communicated with the gap a, so as to flush a small amount of blood stagnating in the gaps a and b along the perfusion direction, the micro pressure measuring element is led out from the wire hole of the five-cavity catheter and placed on the outer wall surface of the flow cone, and the balloon injection tube is led out from the balloon injection hole of the five-cavity catheter and placed on the outer wall surface of the pump body and communicated with the balloon.

2. A balloon catheter blood pump for implantation in the abdominal aorta as defined in claim 1, characterized in that The maximum diameters of the pump body, the flow cone, and the tail sleeve are equal, and the outer contour of the balloon catheter blood pump is smoothly connected.

3. A balloon catheter blood pump for implantation in the abdominal aorta as defined in claim 2, wherein, The wire hole and the balloon injection hole are 5-6 mm smaller than the total length of the five-cavity catheter along the axial length, and side holes for leading out the micro pressure measuring element and the balloon injection tube are arranged on the surface of the five-cavity catheter.

4. A balloon catheter blood pump for implantation in the abdominal aorta as defined in claim 2, wherein, The flow cone includes a cylindrical section and a necked section at the distal end of the cylindrical section, the surface of the cylindrical section is provided with two grooves, the cross sections of the grooves are square and semicircular respectively, the square groove has an axial length of 0.8-1.2 mm along the proximal end surface, and the semicircular groove penetrates through the cylindrical section along the axial direction, the square groove and the semicircular groove are arranged symmetrically on the surface of the cylindrical section.

5. A balloon catheter blood pump for implantation in the abdominal aorta as defined in claim 4, wherein, The outer wall surface of the necked section is a blood flow guiding surface which is formed by a flat wall surface, two arc wall surfaces which are connected in sequence and tangentially, the flat wall surface is arranged at the distal end of the cylindrical section and has a diameter smaller than that of the cylindrical section.

6. A balloon catheter blood pump for implantation in the abdominal aorta as defined in claim 5, wherein, The surface of the tail sleeve is provided with two transition grooves which are arranged axially and penetrate through, the cross section sizes and circumferential positions of the two transition grooves correspond to the square groove and the semicircular groove respectively, the micro pressure measuring element and the balloon injection tube are tightly fitted in the transition grooves of the tail sleeve and the square groove and the semicircular groove of the flow cone respectively.

7. A balloon catheter blood pump for implantation in the abdominal aorta as defined in claim 1, wherein, The central hole is coaxially arranged with the five-cavity catheter, and the wall thickness between the central hole and the other four small holes needs to be at least 0.2 mm.

8. A balloon catheter blood pump for implantation in the abdominal aorta as defined in claim 2, wherein, The inflow cage is a plurality of spaced inflow holes arranged on the upper side wall of the pump body, the outflow cage is a plurality of spaced outflow holes arranged on the lower side wall of the pump body, and the inflow holes and the outflow holes are semicircular; the inflow cage is circularly arc-contracted along the distal end axial direction.

9. A balloon catheter blood pump for implantation in the abdominal aorta as defined in claim 1, wherein, The balloon injection tube should extend to the outer surface of the intermediate section along the rib between the proximal end outflow holes on the pump body; wherein the diameter of the balloon injection tube is not greater than the width of the rib.

10. A balloon catheter blood pump for implantation in the abdominal aorta as defined in claim 1, wherein, The balloon has a maximum inflated diameter in the range of 28-35 mm and is made of PA12 material.

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