BLOOD PUMP

Abstract

A blood pump comprises a pump casing having a blood flow inlet and a blood flow outlet, and an impeller arranged in said pump casing so as to be rotatable about an axis of rotation. The impeller has blades sized and shaped for conveying blood from the blood flow inlet to the blood flow outlet. The blood pump also has an outflow cannula having an upstream end portion, a downstream end portion and an intermediate portion extending between the upstream end portion and the downstream end portion. The upstream end portion of the outflow cannula is connected to the pump casing such that blood is conveyed from the blood flow outlet of the pump casing into and through the intermediate portion of the outflow cannula towards the downstream end portion of the outflow cannula, wherein the downstream end portion has a blood flow outlet through which blood can exit the outflow cannula. At least a portion of the intermediate portion of the outflow cannula has an outer diameter that is larger than an outer diameter of the pump casing.

Claims

1. A blood pump (1; 201; 301), comprising: a pump casing (2; 202; 302) having a blood flow inlet (21; 221; 321) and a blood flow outlet (22; 222; 322), an impeller (3; 203; 303) arranged in said pump casing (2; 202; 302) so as to be rotatable about an axis of rotation for conveying blood from the blood flow inlet (21; 221; 321) to the blood flow outlet (22; 222; 322), and an outflow cannula (4; 204; 304) having an upstream end portion (41; 241; 341), a downstream end portion (43; 243; 343) and an intermediate portion (42; 242; 343) extending between the upstream end portion (41; 241; 341) and the downstream end portion (43; 243; 343), the upstream end portion (41; 241; 341) of the outflow cannula (4; 204; 304) being connected to the pump casing (2; 202; 302) such that blood is conveyed from the blood flow outlet (22; 222; 322) of the pump casing (2; 202; 302) into and through the intermediate portion (42; 242; 342) of the outflow cannula (4; 204; 304) towards the downstream end portion (43; 243; 343) of the outflow cannula (4; 204; 304), wherein the downstream end portion (43; 243; 343) has a blood flow outlet (44; 244; 344) through which blood can exit the outflow cannula (4; 204; 304) and which is arranged at least partially radially inwards relative to an outermost circumference of the outflow cannula's intermediate portion (42; 242; 342), wherein at least a portion of the intermediate portion (42; 242; 342) of the outflow cannula (4; 204; 304) has an outer diameter that is larger than an outer diameter of the pump casing (2; 202; 302), wherein at least the outflow cannula's intermediate portion (42; 242; 342) is sized and shaped to contact an inner wall of a patient's vessel (104; 108) in which the blood pump (1; 201; 301) is placed during operation of the blood pump (1; 201; 301) in order to occlude the vessel (104; 108) during operation of the blood pump (1).

2. The blood pump of claim 1, wherein the blood flow outlet (44; 244; 344) is disposed in the downstream end portion (43; 243; 343), such that blood can exit the outflow cannula (4; 204; 304) at least partially in an axial direction.

3. The blood pump of claim 1 or 2, wherein a cross-sectional area of the blood flow outlet (44; 244; 344) of the outflow cannula's downstream end portion (43; 243; 343) is smaller than a largest cross-sectional area of the outflow cannula's intermediate portion (42; 242; 342), wherein the cross-sectional area of the blood flow outlet (44; 244; 344) of the outflow cannula's downstream end portion (43; 243; 343) is preferably less than 50%, preferably less than 40%, more preferably less than 30%, of the cross-sectional area of the outflow cannula's intermediate portion (42; 242; 342), and/or wherein the blood flow outlet (44; 244; 344) of the outflow cannula's downstream end portion (43; 243; 343) comprises at least two openings, preferably three openings, more preferably four openings.

4. The blood pump of any one of claims 1 to 3, wherein the diameter of the outflow cannula's intermediate portion (42; 242; 342) is at least 1.5 times as large as the diameter of the pump casing (2; 202; 302), preferably twice, more preferably three times, still more preferably four times as large.

5. The blood pump of any one of claims 1 to 4, wherein a largest diameter of the outflow cannula's intermediate portion (42; 242) is between about 5 mm and 2 cm, preferably between about 1 and 1.5 cm, or wherein a largest diameter of the outflow cannula's intermediate portion (342) is preferably between about 0.5 and 5 mm, more preferably about 2 mm.

6. The blood pump of any one of claims 1 to 5, wherein a longitudinal length of the outflow cannula's intermediate portion (42; 242) is less than 5 cm, preferably less than 3 cm, or wherein a longitudinal length of the outflow cannula's intermediate portion (342) is between about 1 and 3 mm.

7. The blood pump of any one of claims 1 to 6, wherein the outflow cannula (4; 204; 304) comprises a material that is softer than a material of the pump casing (2; 202; 302), wherein preferably the material of the outflow cannula (4; 204; 304) is elastic.

8. The blood pump of any one of claims 1 to 7, wherein at least one of the outflow cannula's upstream end portion (41; 241; 341) and the outflow cannula's downstream end portion (43; 243; 343) is tapered.

9. The blood pump of any one of claims 1 to 8, wherein a minimum inner diameter of the outflow cannula's upstream end portion (41; 241; 341) corresponds to an outer diameter of the pump casing (2; 202; 302) and the outflow cannula (4; 204; 304) is sealingly connected to the pump casing (2; 202; 302).

10. The blood pump of any one of claims 1 to 9, comprising a support structure (47; 47) that is arranged around at least a portion of the outflow cannula's intermediate portion (42), wherein preferably the support structure (47; 47) is at least one of a substantially cylindrical and substantially conical pad, the support structure (47; 47) preferably comprising a pharmaceutical substance.

11. The blood pump of any one of claims 1 to 9, comprising a drug eluting device (347), the drug eluting device (347) being configured to deliver a pharmaceutical substance to a target area in a patient, wherein preferably the drug eluting device (347) at least partially surrounds the intermediate portion (342) of the outflow cannula (304), wherein more preferably the drug eluting device (347) is at least one of a substantially cylindrical and substantially conical pad.

12. The blood pump of claim 11, wherein the drug eluting device (347) comprises a reservoir (348) that is connected to an access lumen (360) for at least one of injecting and removing a pharmaceutical substance to or from the reservoir (348).

13. The blood pump of any one of claims 1 to 12, wherein the blood pump (1; 301) is connected to a catheter (5; 305) that extends from the pump casing (2; 302) through the outflow cannula (4; 304), or wherein the blood pump (201) is connected to a catheter (205) that extends from the pump casing (202) in a direction away from the outflow cannula (204).

14. The blood pump of any one of claims 1 to 13, wherein the blood pump (1; 201; 301) is an axial blood pump, a centrifugal blood pump or a mixed-type blood pump, and/or wherein the blood pump is configured to be placed in a human patient's renal vein (104) to pump blood from the patient's kidney (105) towards the patient's inferior vena cava (103), or configured to be placed in a human patient's coronary artery (108).

15. A method for supporting a blood flow in a patient's blood vessel using a blood pump, the blood pump (1; 201; 301) comprising a pump casing (2; 202; 302) having a blood flow inlet (21; 221; 321) and a blood flow outlet (22; 222; 322), an impeller (3; 203; 303) arranged in said pump casing (2; 202; 302) so as to be rotatable about an axis of rotation for conveying blood from the blood flow inlet (21; 221; 321) to the blood flow outlet (22; 222; 322), and an outflow cannula (4; 204; 304) having an upstream end portion (41; 241; 341), a downstream end portion (43; 243; 343) and an intermediate portion (42; 242; 343) extending between the upstream end portion (41; 241; 341) and the downstream end portion (43; 243; 343), the upstream end portion (41; 241; 341) of the outflow cannula (4; 204; 304) being connected to the pump casing (2; 202; 302) such that blood is conveyed from the blood flow outlet (22; 222; 322) of the pump casing (2; 202; 302) into and through the intermediate portion (42; 242; 342) of the outflow cannula (4; 204; 304) towards the downstream end portion (43; 243; 343) of the outflow cannula (4; 204; 304), wherein the downstream end portion (43; 243; 343) has a blood flow outlet (44; 244; 344) through which blood can exit the outflow cannula (4; 204; 304) and which is arranged at least partially radially inwards relative to an outermost circumference of the outflow cannula's intermediate portion (42; 242; 342), wherein at least a portion of the intermediate portion (42; 242; 342) of the outflow cannula (4; 204; 304) has an outer diameter that is larger than an outer diameter of the pump casing (2; 202; 302), the method comprising the steps of: operating the blood pump (1; 201; 301), when placed in in the patient's blood vessel, such that at least the outflow cannula's intermediate portion (42; 242; 342) contacts an inner wall of the patient's vessel (104; 108) in which the blood pump (1; 201; 301) is placed during operation of the blood pump (1; 201; 301) so as to occlude the vessel (104; 108) during operation of the blood pump (1).

16. The method of claim 15, wherein the blood pump is placed in a human patient's renal vein (104) to pump blood from the patient's kidney (105) towards the patient's inferior vena cava (103).

17. The method of claim 15, wherein the blood pump is placed in a human patient's coronary artery (108).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The foregoing summary, as well as the following detailed description of preferred embodiments, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, reference is made to the drawings. The scope of the disclosure is not limited, however, to the specific embodiments disclosed in the drawings. In the drawings:

[0028] FIG. 1a shows a cross-sectional view of a blood pump according to the invention.

[0029] FIG. 1b shows a perspective view of the blood pump of FIG. 1a.

[0030] FIG. 2a shows a cross-sectional view of the pump casing of the blood pump of FIG. 1a.

[0031] FIG. 2b shows a perspective view of the pump casing of the blood pump of FIG. 1a.

[0032] FIG. 3 shows a perspective view of the blood pump of FIG. 1a.

[0033] FIG. 4a shows a cross-sectional view of an embodiment of the outflow cannula.

[0034] FIG. 4b shows a perspective view of an embodiment of the outflow cannula.

[0035] FIG. 5a shows a cross-sectional view of another embodiment of the outflow cannula.

[0036] FIG. 5b shows a perspective view of another embodiment of the outflow cannula.

[0037] FIG. 6a shows the blood pump of FIG. 1a placed in a patient's renal vein.

[0038] FIG. 6b shows an enlarged view of a detail of FIG. 6a.

[0039] FIG. 7a shows a cross-sectional view of a blood pump according to another embodiment.

[0040] FIG. 7b shows a perspective view of the blood pump of FIG. 7a.

[0041] FIG. 8a shows a cross-sectional view of a blood pump according to another embodiment.

[0042] FIG. 8b shows a perspective view of the blood pump of FIG. 8a.

[0043] FIG. 9 shows a perspective view of the pump casing of the blood pump of FIG. 8a.

[0044] FIG. 10 shows another perspective view of the pump casing of the blood pump of FIG. 8a.

[0045] FIG. 11 shows a perspective view of the impeller of the blood pump of FIG. 8a.

[0046] FIG. 12 shows a schematic partial view of an embodiment of the outflow cannula.

[0047] FIG. 13a shows the blood pump of FIG. 8a placed in a patient's coronary artery.

[0048] FIG. 13b shows an enlarged view of a detail of FIG. 13a.

DETAILED DESCRIPTION

[0049] Referring to FIGS. 1a and 1b, a blood pump 1 according to the invention is shown. The blood pump 1 comprises a pump casing 2 with a rotatable impeller 3 and an outflow cannula 4 connected to the pump casing 2. The outflow cannula 4 has an upstream end portion 41, a downstream end portion 43 and an intermediate portion 42 extending therebetween. The upstream and downstream end portions 41 and 43 may be tapered to facilitate insertion of the blood pump 1 into a patient's vessel. The cannula 4 will be collapsed during insertion. Therefore, the taper may enhance the flow pattern of the pump 1. The taper at the upstream end portion 41 may allow the pump to wedge itself in a smaller vessel. The pump casing 2 may be cylindrical. However, it will be appreciated that other appropriate designs and shapes are possible as long as they achieve the function of the blood pump 1 according to the invention as described in more detail below. A catheter 5 is connected to the blood pump 1 to deploy it within a patient's vessel and to supply the blood pump 1 with electric energy. Upon rotation of the impeller 3, blood is drawn into the blood pump 1 through the pump casing 2, into the outflow cannula 4 and out of the blood pump 1 through openings 44 in the downstream end portion 43 of the outflow cannula 4 as indicated by arrows in FIG. 6b.

[0050] FIGS. 2a and 2b show the pump casing 2 of the blood pump 1. The pump casing 2 has a blood flow inlet 21 and a blood flow outlet 22. In this embodiment, the blood flow inlet 21 is an axial opening spanned by a protection structure 24, such as a grill to prevent soft tissue from entering the blood flow inlet 21. It will be appreciated that any other suitable means for preventing soft tissue from entering the pump casing 2 can be chosen. The blood flow outlet 22 is formed by radial openings spaced from the blood flow inlet 21 along the longitudinal direction in the direction of flow. Thus, the blood pump 1 can be considered a mixed-type blood pump, where the blood flow has axial and radial components. However, the blood pump may also be formed as an axial or centrifugal blood pump. As can be seen in FIG. 1a, the outflow cannula 4 is connected to the pump casing 2 such that the blood flow outlet 22 is disposed inside the outflow cannula 4 to cause a blood flow into and through the outflow cannula 4. The impeller 3 is disposed within the pump casing 2 and has blades 31 to convey blood from the blood flow inlet 21 to the blood flow outlet 22. Rotation of the impeller 3 is caused by a drive unit 23, such as an electric motor. The drive unit may alternatively be provided outside the blood pump, in which case rotation is transmitted via a flexible drive cable located inside (not shown) catheter 5 from an external drive unit to the impeller. FIG. 3 is a perspective view of the blood pump 1, showing in particular the downstream end portion 43 of the outflow cannula 4 having openings 44 for the blood flow and an aperture 45 for receiving the catheter 5. The openings 44 together form a smaller cross-sectional area than the intermediate portion 42. Thus, during operation of the blood pump 1, pressure is increased in the outflow cannula 4 such that the outflow cannula 4 is unfolded or even expanded or inflated. Due to the comparatively large diameter of the outflow cannula 4, the outflow cannula 4 is caused to contact an inner wall of a patient's vessel, thereby sealing and occluding the vessel to prevent blood from flowing in a backward direction. In this embodiment, four openings 44 are shown. It will be appreciated that there may be only a single opening, two or three, or more than four openings as long as sufficient pressure stasis is caused to unfold or expand the outflow cannula 4 and press it against the inner wall of a vessel in which the blood pump 1 is placed. A pressure difference between the inside and outside of the outflow cannula 4 may be for instance about 20 mmHg. Preferably, however, this differential pressure will not exceed 15 mmHg.

[0051] In order to improve the valve function of the outflow cannula 4, that is to say, in order to improve the sealing contact between the outflow cannula 4 and the patient's vessel, a pad 47 may be provided as shown in FIGS. 4a, 4b. The pad 47 is arranged around the circumference of the intermediate portion 42 of the outflow cannula 4. It may be made of a soft material or may be hollow and filled with a fluid. The pad 47 allows the outflow cannula 4 to better conform to the shape of the patient's vessel independently of the blood pressure within the outflow cannula 4. FIGS. 4a and 4b show an embodiment in which the pad 47 is substantially cylindrical. It may extend over the entire intermediate portion 42 or only over a part of it, in particular with respect to the longitudinal direction. A similar embodiment is shown in FIGS. 5a and 5b, it being identical to the previous embodiment except for the shape of the pad. The pad 47 is tapered or wedge-shaped with a diameter of the pad 47 increasing in the direction of flow. This shape may improve occlusion of the vessel in which the blood pump 1 is placed.

[0052] An application of the blood pump 1 is shown in FIGS. 6a and 6b. The blood pump 1 is used as a renal pump to pump blood from a patient's kidney 105 through the renal vein 104 towards the inferior vena cava 103. FIG. 6a also shows the patient's heart 100, the aorta 101 and the superior vena cava 102. As can be seen particularly in FIG. 6b, the blood pump 1 fully occludes or blocks the renal vein 104. A typical diameter of the renal vein is about 1 cm. Thus, an appropriate diameter of the intermediate portion 42 of the outflow cannula 4 would be about 1.1 or 1.5 cm. The blood pump 1 according to the invention can prevent a backflow of blood towards the kidney 105 and, therefore, effectively pump blood towards the inferior vena cava 103. This treatment can be applied in case a patient suffers from malfunction of the left or right ventricle, which may lead to high blood pressure in the vena cava and, therefore, to kidney failure because of poor blood flow away from the kidney. The blood pump 1 supports this blood flow. The blood flow caused by the blood pump 1 may be for instance between about 0.5 and 2 liters per minute. It will be appreciated that other applications of the blood pump are possible, e.g. in a pulmonary artery.

[0053] In other applications, for example if the blood pump is to be placed in the renal artery 106 or in the pulmonary artery 107, a reverse flow configuration may be needed. That is to say, the blood pump in a reverse flow configuration pumps the blood in an opposite direction compared to the previously discussed embodiments. While in the previously discussed embodiments the blood is pumped towards the catheter, it may be necessary in other applications to pump the blood in a direction away from the catheter due to restricted access possibilities in the human body. Also, if a blood pump is to be placed in a patient's coronary artery, a reverse flow configuration is needed.

[0054] An embodiment that is similar to that of FIG. 1a but has an opposite direction of flow compared to the blood pump of FIG. 1a is shown in FIGS. 7a and 7b. The blood pump 201 comprises a pump casing 202 and an outflow cannula 204 having a larger diameter than the pump casing 202. An impeller 203 is arranged in the pump casing 202 and driven by a drive unit 223, such as an electric motor that is magnetically coupled to the impeller 203. The pump casing 202 is connected to a catheter 205. The impeller 203 conveys blood from a blood flow inlet 221 to a blood flow outlet 222 and into the outflow cannula 204. The blood flow inlet 221 is in close proximity to the outflow cannula 204 such that the larger diameter of the outflow cannula 204 helps keeping tissue of the vessel away from the blood flow inlet 221.

[0055] As in the previous embodiments, the outflow cannula 204 comprises an upstream end portion 241, an intermediate portion 242 and a downstream end portion 243. The downstream end portion 243 has openings 244 through which blood can exit the outflow cannula 204 as described in connection with the previous embodiments. Since the catheter 205 does not extend through the outflow cannula 204, a catheter extension 250 is provided that extends through the outflow cannula 204 and out of an aperture 245 in the downstream end portion 243 to be able to guide the blood pump 201 during insertion into the patient's vessel. An atraumatic tip 251, such as a J-tip or pigtail is disposed at the end of the catheter extension 250. The tip 251 prevents harm to the patient's vessel during insertion of the blood pump 201.

[0056] FIGS. 8a to 13b illustrate another embodiment of a blood pump 301. The structure of the blood pump 301 is similar to those described above, in particular the embodiment of FIGS. 7a and 7b with regards to the direction of flow. However, the blood pump 301 is intended to be used in a patient's coronary artery 108 (see FIGS. 13a, 13b). Thus, its diameter is smaller compared to e.g. a renal pump, for example about 2 mm. The blood pump 301 comprises a pump casing 302 connected to a catheter 305. A rotatable impeller 303 is disposed in the pump casing 302, and an outflow cannula 304 is connected to the pump casing 302. Due to the small diameter of the blood pump 301 the drive unit (not shown) is disposed external to the blood pump 301. Rotation of the drive unit is transmitted to the impeller 303 through the catheter 305 via a flexible drive shaft (not shown). Alternatively, for pumps with diameter between 3 and 5 mm a direct drive motor could be used, wherein the motor is situated right behind the pump. In this case a flexible drive shaft will not be required. Upon rotation of the impeller 303, blood is drawn into the blood pump 301 through the pump casing 302, into the outflow cannula 304 and out of the blood pump 301 through openings 344 in the downstream end portion 343 of the outflow cannula 304 as indicated by arrows in FIG. 13b.

[0057] The outflow cannula 304 has an upstream end portion 341, a downstream end portion 343 and an intermediate portion 342 extending therebetween. The upstream and downstream end portions 341 and 343 may be tapered to facilitate insertion of the blood pump 301 into the patient's vessel, such as a coronary artery. The cannula 304 will be collapsed during insertion. The taper at the downstream end portion 343 may allow the pump to wedge itself in a small vessel. The pump casing 302 may be cylindrical. However, it will be appreciated that other appropriate designs and shapes are possible as long as they achieve the function of the blood pump 301.

[0058] The catheter 305 does not extend through the outflow cannula 304 but is connected to the blood pump 301 at its inlet end. Thus, a catheter extension 350 is connected to the pump casing 302 that extends through the outflow cannula 304 and exits the outflow cannula 304 through an aperture 345 at the downstream end portion 343 so as to be able to guide the blood pump 301 through a patient's vessel by means of the catheter 305 during insertion of the blood pump 301. The catheter extension 350 is provided with an atraumatic tip 351, such as a J-tip or pigtail in order to prevent harm to the patient's vessel, such as puncturing of the vessel.

[0059] The pump casing 302 is illustrated in more detail in FIGS. 9 and 10. FIG. 9 is a perspective view of the blood flow inlet 321 of the pump casing 302, whereas FIG. 10 is a perspective view of the blood flow outlet 322 of the pump casing 302. In order to prevent suction of tissue into the pump casing 302, a protection structure, such as a grill 324 is disposed over the blood flow inlet 321. The grill 324 may have a curved shape. However, any other means to protect tissue from being sucked into the blood pump 301 can be provided. Likewise, a protection structure, such as a grill 326 is provided at the blood flow outlet 322 to protect the outflow cannula 304 or tissue from the rotating impeller 303. Struts 325 and 327 are provided at the inlet 321 and outlet 322, respectively, to support the grill 324 and 326 respectively.

[0060] The impeller 303 is shown in more detail in FIG. 11. The impeller 303 is coupled to a drive shaft extending through the catheter 305 as explained in the aforementioned. Blades 331 are disposed on an impeller shaft 332 which convey blood from the pump casing's blood flow inlet 321 to the blood flow outlet 322 upon rotation of the impeller shaft 332. Stator blades 333 are provided at the upstream end of the impeller 303 in order to reduce turbulences of the blood flow and to engage and center the impeller 303 and the catheter 305 in the center of the pump casing 302. The stator blades 333 are either press fitted, welded, or bonded to the inside diameter of the pump casing 302. The center portion of the stator blades 333 serves as a bearing that engages the impeller shaft 332.

[0061] The blood pump 301 does not only function as a pumping device but also as a drug eluting device. Application of medicaments, such as anti-inflammatory, antibiotics, anti-coagulants, or growth inhibitors is of particular importance in coronary artery applications. For this purpose, a drug eluting device, such as a drug eluting pad 347 is disposed on the outflow cannula 304. The outflow cannula 304 has a sufficiently large diameter to bring the drug eluting pad 347 close to the inner wall of the vessel. Preferably, the drug eluting pad 347 contacts the vessel wall or is pressed against it. In particular, this may be achieved by expanding the outflow cannula 304 as described in connection with the previous embodiments, wherein the outflow cannula 304 has a larger outer diameter than the pump casing 302. However, in some embodiments the outflow cannula 304 might not have a larger outer diameter than the pump casing 302.

[0062] The drug eluting pad 347 may assume any suitable size and shape to deliver drugs to the target area. The drug eluting pad 347 may be tubular or ring shaped, or may comprise separate discrete portions. The pad 347 may be made of a continuous or porous material or may be hollow and filled with a substance comprising the drugs. The wall of the pad 347 may then comprise apertures or may be permeable to enable a desired amount of drugs to penetrate the wall of the drug eluting device. Since the drug eluting pad 347 is disposed on the outflow cannula 304 it can be brought into direct contact with the target area, such as the inner vessel wall. In another embodiment as shown in FIG. 12, the drug eluting device 347 may comprise a reservoir 348 that is connected to an access lumen, such as a tubular access 360 in order to inject drugs into the reservoir 348 or remove drugs therefrom. The reservoir 348 may be formed as a recess that is at least partially open at a surface facing the wall of the vessel. The reservoir 348 may have a plurality of apertures 349 to release the medicaments.

[0063] The blood pump 301 is particularly designed for an application in a patient's coronary artery 108 as shown in FIGS. 13a and 13b. It is inserted through the aorta 101 towards at the patient's heart 100 and into one of the coronary arteries 108, which may have been blocked due to a stenosis. Drugs can be effectively delivered to the coronary artery 108 by means of the drug eluting pad 347. The coronary artery 108 is not blocked as by known balloon devices because the blood pump 301 ensures a blood flow through the coronary artery 108. Therefore, the blood pump 301 can be kept in the coronary artery 108 for a sufficiently long time to deliver a desired amount of medicaments.