Blood pump and blood pump system

Abstract

The present invention relates to a blood pump comprising a pump head, a cable attached to the pump head, at least one optical fiber comprising a first optical fiber end and a second optical fiber end, and a length adaption device having an optical fiber inlet and an optical fiber outlet. The optical fiber is at least partially disposed within the cable, wherein the optical fiber comprises a length adaption portion disposed within the length adaption device, and wherein a length of optical fiber of the length adaption portion is greater than a length of a direct connection between the optical fiber inlet and the optical fiber outlet of the length adaption device.

Description

[0001] Blood pump and blood pump system

[0002] BACKGROUND

[0003] The present invention relates to a blood pump and to a blood pump system comprising the blood pump. In particular, the present invention relates to an intravascular blood pump for percutaneous insertion into a patient’s blood vessel, to support a blood flow in a patient’s blood vessel. The blood pump may also be an intracardiac blood pump or any other kind of ventricular assist device.

[0004] Such blood pumps usually comprise an implantable pump head intended to unload blood from one area to another area within the human body. For instance, the blood pump may be used as a left ventricular assist device unloading blood from the left ventricle to the aorta. Of course, the blood pump may also be used a right ventricular assist device or as an assist device for pediatric applications.

[0005] Therefore, a pump element (e.g., an impeller) is disposed within the pump head which generates a blood flow from a blood flow inlet of the pump head to a blood flow outlet of the pump head upon rotation thereof. In case of a left ventricular assist device, the blood flow inlet is disposed within the left ventricle of a human heart and the blood flow outlet is disposed within the aorta.

[0006] Rotation of the pump element to generate the blood flow may for instance be caused by an internal motor disposed within the pump head or within a pump housing functionally connected to the pump head. The internal motor is usually configured as an electric motor and rotation may be transmitted to the pump element e.g., via a shaft or by a non- contact drive, like a magnetic drive.

[0007] To energize and control the internal motor, a cable is attached to the pump head which runs through the patient’s vasculature and exist percutaneously through the patient’s skin at a suitable location of the human body. Furthermore, for controlling and monitoring the functionality of the blood pump, sensors or the like are attached to the pump head or positioned in close vicinity to the pump head. The sensors are configured to sense different parameters, like blood pressure. The usage of optical sensors is of particular advantage, as optical sensors do not interfere with electric fields or magnetic fields and thus deliver reliable measurements. Usually, optical fibers are used to transfer and transmit the signals of the optical sensor. To prevent damage of the optical fibers, the optical fibers are usually disposed within the cable. Of course, other solutions like a separate sheathing of the optical fiber are also possible.

[0008] Further, the optical fibers are to be handled carefully and straining is to be avoided under any event. As the optical fiber is usually housed within a cable, bending of the cable may cause the optical fiber to elongate or shorten, as the optical fiber is not centrally provided within the cable, but off-center, which also needs to be accounted for. Hence, there is the need to provide a solution for length adaption of an optical fiber of a blood pump.

[0009] The problem is solved with a blood pump according to claim 1 . Preferred embodiments are described in the dependent claims.

[0010] SUMMARY OF THE INVENTION

[0011] According to a first aspect, a blood pump may comprise a pump head, a cable attached to the pump head, at least one optical fiber and a length adaption device. The optical fiber may comprise a first optical fiber end and a second optical fiber end. The length adaption device may comprise an optical fiber inlet and an optical fiber outlet. The optical fiber may at least partially be disposed within the cable. The optical fiber may comprise a length adaption portion disposed within the length adaption device. A length of the length adaption portion may be greater than a length of a direct connection between the optical fiber inlet and the optical fiber outlet.

[0012] In other words, a direct line between optical fiber inlet and the optical fiber outlet has length which is less than the length of the optical fiber of the length adaption portion. Thus, the length adaption device “shortens” the optical fiber in the pre-assembled state of the blood pump. In case the physician wants to enlarge the available length of the optical fiber, the length adaption device may release some further length of the optical fiber. On the other hand, the length adaption device may also “take up” some length of the optical fiber to shorten the available length of the optical fiber.

[0013] This is of particular advantage when implanting the blood pump, as bending of the cable during implantation requires the optical fiber to adapt thereto to avoid straining and or damage of the optical fiber. The length adaption device thus can variably release or take up length of the optical fiber to account therefore.

[0014] Preferably, the optical fiber of the length adaption portion is at least partially coiled and / or rolled up and / or looped and / or laid in loops and / or stacked and / or laid in stacks and / or webbed and / or laid in webs and / or spirally arranged and / or provided in waves. Thus, due to the those curvatures, the optical fiber of the length adaption portion has a greater length than the length of the direct connection between the optical fiber inlet and the optical fiber outlet.

[0015] Preferably, the length adaption device is configured to be implanted into a human body. Preferably, the length adaption device is composed of a biocompatible material. Preferably, the length adaption device comprises a housing composed of titanium or a titanium alloy. Preferably, the housing comprises at least two shells being welded to each other. Preferably, the housing is formed of the at least two shells. Thus, the housing provides a hollow body with that portion of the optical fiber constituting the length adaption portion being housed within the hollow body.

[0016] Preferably, the optical fiber of the length adaption portion is freely movable within the length adaption device.

[0017] Preferably, the length adaption device comprises a cable inlet portion and a cable outlet portion, wherein the cable is preferably supported in the cable inlet portion and in the cable outlet portion. Preferably, a potting material is provided between the cable inlet portion and the cable and / or between the cable outlet portion and the cable. This hinders ingression of liquid into the interior of the length adaption device. Additional sealing members may be provided if desired.

[0018] Preferably, the length adaption device is disposed within the cable. The length adaption device may comprise a cylindrical member, wherein the length adaption portion may be coiled about the cylindrical member, wherein the length adaption portion may be configured to be slidable along the axial extension of the cylindrical member. The cylindrical member may be an inner cable disposed within the cable and covered by a sheathing to form the cable. Due to the coiling and the slidability of the length adaption portion, the length adaption portion acts spring-like and may be compressed (the distance between the coils is reduced) to reduce the available length of the optical fiber or may be stretched (the distance between the coils is enlarged) to enlarge the available length of the optical fiber.

[0019] The blood pump may comprise a ferrule provided at the first optical fiber end. The ferrule may comprise a ferrule housing and a preloading element. The ferrule housing may comprise a connecting end and an optical fiber end. The preloading element may preload the optical fiber towards the connecting end. The length adaption device may be provided within the ferrule. The length adaption device may be provided radially inwardly of the preloading element.

[0020] The ferrules known from the prior art are usually pre-loaded by a spring having a relatively high force at relatively low travel length to securely create a full contact between the first optical fiber end and the element the first optical fiber end is to be attached to e.g., another ferrule. Here, this configuration is altered to obtain a lower preloading force and a comparably higher travel length to allow for an adjustment of the available length of the optical fiber.

[0021] The blood pump may further comprise a connector, wherein the cable comprises a first cable end attached to the pump head and a second cable end attached to the connector.

[0022] Preferably, the length adaption device is disposed within the connector. The length adaption device may comprise a cylindrical member, wherein the length adaption portion is preferably coiled about the cylindrical member and wherein the length adaption portion is preferably configured to be slidable along the axial extension of the cylindrical member. Due to the coiling and the slidability of the length adaption portion, the length adaption portion acts spring-like and may be compressed (the distance between the coils is reduced) to reduce the available length of the optical fiber or may be stretched (the distance between the coils is enlarged) to enlarge the available length of the optical fiber.

[0023] The connector may comprise at least one optical fiber connection and at least one electrical connection.

[0024] The ferrule may be provided within the connector. A ferrule may also be provided within length adaption device.

[0025] According to a second aspect, a blood pump system is provided. The blood pump system comprises at least one control console and a blood pump described above. The blood pump is connected to the control console. Preferably, the control console comprises a control console connector connected to the connector of the cable.

[0026] The optical fiber may also be an optical conductor or any other elongated transmitting device capable of transmitting signals. The cable may at least partially be disposed within a catheter. The cable does not necessarily needs to be used for energizing the internal motor of the blood pump. Rather, the cable may also be considered as a kind of sheathing with only the at least one optical fiber being at least partially disposed with the sheathing.

[0027] The blood pump may comprise two or more of the length adaption devices described above. The length adaption devices may be different e.g., provided in the connector and in the ferrule.

[0028] As apparent from the above description, the length of the optical fiber of the length adaption portion is variable and depends on the needs of the physician. In other words, in case the physician needs more or less length of the optical fiber, the length adaption device can adapt thereto. Thus, the available length of the optical fiber may vary between the original pre-assembled state and the final state when the blood pump is implanted into the human body.

[0029] BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The foregoing summary, as well as the following detailed description of exemplary 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:

[0031] Fig. 1 is a schematic view of a blood pump system comprising a blood pump;

[0032] Fig. 2 shows a first embodiment of a blood pump,

[0033] Fig. 3 is a schematic overview of a blood pump, a cable and a connector,

[0034] Fig. 4a is an example for a length adaption portion,

[0035] Fig. 4b is another example of a length adaption portion,

[0036] Fig. 4c is another example of a length adaption portion,

[0037] Fig. 4d is another example of a length adaption portion, and

[0038] Fig.4e is another example of a length adaption portion.

[0039] DETAILED DESCRIPTION

[0040] Embodiments of the present disclosure are described in detail with reference to the figures wherein like reference numerals identify similar or identical elements. It is to be understood that the disclosed embodiments are merely examples of the disclosure, which may be embodied in various forms. Well known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.

[0041] To provide an overall understanding of the systems, methods, and devices described herein, certain illustrative examples will be described. Although various examples may describe intravascular blood pumps, it will be understood that the improvements of the present technology may also be adapted and applied to other types of medical devices such as electrophysiology study and catheter ablation devices, angioplasty and stenting devices, angiographic catheters, peripherally inserted central catheters, central venous catheters, midline catheters, peripheral catheters, inferior vena cava filters, abdominal aortic aneurysm therapy devices, thrombectomy devices, TAVR delivery systems, cardiac therapy and cardiac assist devices, including balloon pumps, cardiac assist devices implanted using a surgical incision, and any other venous or arterial based introduced catheters and devices. As is known, intravascular blood pumps can be introduced into a patient, either surgically or percutaneously, to deliver blood from one location in the heart or circulatory system to another location in the heart or circulatory system. For example, when deployed in the left ventricle, an intravascular blood pump can pump blood from the left ventricle of the heart into the aorta. When deployed in the right ventricle, an intravascular blood pump can pump blood from the inferior vena cava into the pulmonary artery.

[0042] Fig. 1 shows a schematic view of a human body B. As shown, a blood pump system 10 comprising a blood pump 12 is provided. The blood pump 12 comprises a pump head 14. In this exemplary embodiment, the pump head 14 is deployed in the heart H of the human body B and in particular in the left ventricle. Thus, the blood pump 12 is a left ventricular support device in this exemplary embodiment.

[0043] The blood pump system 10 further comprises a cable 16 attached to the pump head 14 at a first cable end. A connector 50 is provided at a second cable end. The connector 50 is connected to a control console connector 48 attached to a control console 46. Here, the control console 46 comprises of a portable controller and a battery pack.

[0044] The blood pump 12 further comprises at least one optical fiber 18 having a first optical fiber end 20 and a second optical fiber end 22. The second optical fiber end 22 is attached to a device which may be supported on the pump head 14 e.g., a sensor for sensing and monitoring blood related parameters like blood pressure. The optical fiber 18 is at least partially disposed in the cable 16.

[0045] The blood pump 12 further comprises a length adaption device 24 as will be explained in more detail below. The length adaption device 24 is intended to adjust the available length of the optical fiber 18. The available length as used herein is not to be understood as the entire length of the optical fiber 18 when fully extended. In the pre-assembled state of the blood pump 12, the available length is the length between the first optical fiber end 20 and the second optical fiber end 24 which is less than the entire length of the optical fiber 18, as a certain portion (via a length adaption portion of the optical fiber 18) of the entire length of the optical fiber 18 is “shortened” by length adaption device 24.

[0046] A first example for a length adaption device 24 is shown in Fig. 2. For lucidity reasons, the cable is not shown in Fig. 2. Here, the length adaption 24 device is configured to be implantable into the human body B. The length adaption device 24 comprises an optical fiber inlet 26 and an optical fiber outlet 28. Further, the length adaption device 24 comprises a housing 32 composed of a biocompatible material e.g., titanium or titanium alloy. For instance, the housing 32 is composed of two shells which are welded together. The housing 32 comprises a cable inlet portion and a cable outlet portion, wherein the cable is supported in the cable inlet portion and in the cable outlet portion. The cable inlet portion and the cable outlet portion are sealed to prevent ingression of fluids e.g., by a potting material provided in the cable inlet portion and the cable outlet portion. Of course, other sealing elements may be used alternatively or supplementary, like sealing rings. In the embodiment, the cable inlet portion coincides with the optical fiber inlet 26 and the cable outlet portion coincides with optical fiber outlet 28. The cable 16 may be stripped from its outer layers (i.e., the sheathing) so that the optical fiber 18 can move freely within the housing 32.

[0047] The length adaption portion 30 of the optical fiber 18 is disposed within the length adaption device 24. In the example of Fig. 2, the length adaption portion 20 comprises a loop, so that the entire length of the length optical fiber of the length adaption portion is greater than the length L1 between the optical fiber inlet 26 and the optical fiber outlet 28 of the length adaption device 24 in the pre-assembled state. The length of the length adaption portion 30 is variable and depends on the needs of the physician. The loop shown in Fig. 2 can be enlarged to shorten the available length of the optical fiber 18 or can be downsized to enlarge the available length of the optical fiber 18.

[0048] The length adaption portion 30 may also have other shapes as shown in Figs. 4a to 4d e.g., coiled, waveform, several loops, stacked or the like. Of course, combinations are also possible.

[0049] As shown in Fig. 4a, the length adaption device 4a may comprise a cylindrical member 34 with the optical fiber 18 coiled about the cylindrical member 34 to establish the length adaption portion 30. The cylindrical member 34 may be a separate member or may be a member anyhow provided. For instance, the cable 16 may comprise the length adaption portion 30 in that the cable 16 comprises an inner cable (i.e., the cylindrical member 34) with the optical fiber 18 coiled about the inner cable. The inner cable and the optical fiber 18 are sheathed. For instance, such a length adaption device 24 may be provided in the region A shown with a dashed line in Fig. 3.

[0050] The cylindrical member 34 may also be a separate member provided e.g., in the connector 50.

[0051] The length adaption portion 30 is configured to be slidable along the axial extension of the cylindrical member 34. Due to the coiling and the slidability of the length adaption portion 30, the length adaption portion 30 acts spring-like and may be compressed (the distance between the coils is reduced) to reduce the available length of the optical fiber 18 or may be stretched (the distance between the coils is enlarged) to enlarge the available length of the optical fiber 18.

[0052] The length adaption device 24 may also be provided within a ferrule 36. The ferrule 36 comprises a ferrule housing 38 and a preloading element 40 in form of a spring The ferrule housing 38 comprises a connecting end 42 and an optical fiber end 44. The optical fiber 18 is introduced via the optical fiber end 42 and the preloading element 40 preloads the optical fiber 18 towards the connecting end 42. The length adaption portion 30 is disposed radially inwardly of the preloading element 40 and the optical fiber 18 of the length adaption portion 30 may have a wave form, as shown in Fig. 4e. Of course, other shapes are also possible e.g., loops. The preloading force of the preloading element 40 is chosen to be lower than the preloading force of preloading elements of known ferrules, but the travel length of the preloading element 40 is higher than that of known ferrules, which thus allows for an adjustment of the available length of the optical fiber 18.

[0053] The ferrule 36 may be provided within the connector 50 and / or within housing 32 shown in Fig. 2. Coming back to Fig. 2, the optical fiber 18 may be separated from the rest of the cable 16, split, placed in loops or the like and then connected via ferrules 36 disposed within the housing 32.

[0054] The terms “at least partially” or “partially” as used herein are to be understood as only in parts or completely or entirely respectively.

[0055] List of reference signs

[0056] 10 blood pump system

[0057] 12 blood pump

[0058] 14 pump head

[0059] 16 cable

[0060] 18 optical fiber

[0061] 20 first optical fiber end

[0062] 22 second optical fiber end

[0063] 24 length adaption device

[0064] 26 optical fiber inlet

[0065] 28 optical fiber outlet

[0066] 30 length adaption portion

[0067] 32 housing

[0068] 34 cylindrical member

[0069] 36 ferrule

[0070] 38 ferrule housing

[0071] 40 preloading element

[0072] 42 connecting end

[0073] 44 optical fiber end

[0074] 46 control console

[0075] 48 control console connector

[0076] 50 connector

[0077] B human body

[0078] H heart

[0079] L1 length between optical fiber inlet and optical fiber outlet

Claims

CLAIMS1 . Blood pump comprising: a pump head, a cable attached to the pump head, at least one optical fiber comprising a first optical fiber end and a second optical fiber end, and a length adaption device having an optical fiber inlet and an optical fiber outlet, wherein the optical fiber is at least partially disposed within the cable, wherein the optical fiber comprises a length adaption portion disposed within the length adaption device, and wherein a length of the optical fiber of the length adaption portion is greater than a length of a direct connection between the optical fiber inlet and the optical fiber outlet of the length adaption device.

2. Blood pump according to claim 1 , wherein the optical fiber of the length adaption portion is at least partially coiled and / or rolled up and / or looped and / or laid in loops and / or stacked and / or laid in stacks and / or webbed and / or laid in webs and / or spirally arranged and / or provided in waves.

3. Blood pump according to claim 1 or 2, wherein the length adaption device is configured to be implanted into a human body.

4. Blood pump according to claim 3, wherein length adaption device comprises a housing composed of titanium or a titanium alloy.

5. Blood pump according to claim 4, wherein the housing comprises at last to shells being welded to each other.

6. Blood pump according to any one of the preceding claims 1 to 5, wherein the length adaption device comprises a cable inlet portion and a cable outlet portion, wherein the cable is supported in the cable inlet portion and in the cable outlet portion.

7. Blood pump according to claim 6, wherein a potting material is provided between the cable inlet portion and the cable and / or between the cable outlet portion and the cable.

8. Blood pump according to claim 1 or 2, wherein the length adaption device is disposed within the cable.

9. Blood pump according to claim 8, wherein the length adaption device comprises a cylindrical member, wherein the length adaption portion is coiled about the cylindrical member, wherein the length adaption portion is preferably configured to be slidable along the axial extension of the cylindrical member.

10. Blood pump according to claim 1 or 2, wherein the blood pump comprises a ferrule provided at the first optical fiber end, wherein the length adaption device is provided within the ferrule.

11. Blood pump according to claim 10, wherein the ferrule comprises a ferrule housing and a preloading element, wherein the ferrule housing comprises a connecting end and an optical fiber end, and wherein the preloading element preloads the optical fiber towards the connecting end.

12. Blood pump according to claim 11 , wherein the length adaption device is disposed radially inwardly of the preloading element.

13. Blood pump according to claim 1 or 2, wherein the blood pump further comprises a connector, wherein the cable comprises a first cable end attached to the pump head and a second cable end attached to the connector, and wherein the length adaption device is disposed within the connector.

14. Blood pump according to claim 13, wherein the length adaption device comprises a cylindrical member, wherein the length adaption portion is coiled about the cylindrical member, wherein the length adaption portion is preferably configured to be slidable along the axial extension of the cylindrical member.

15. Blood pump according to any one of the preceding claims 1 to 12, wherein the blood pump further comprises a connector, wherein the cable comprises a first cable end attached to the pump head and a second cable end attached to the connector.

16. Blood pump according to any one of the preceding claims 13 to 15, wherein the connector comprises at least one optical fiber connection and at least one electrical connection.

17. Blood pump system comprising at least one control console and blood pump according to any one of the preceding claims 13 to 16, wherein the control console comprises a control console connector connected to the connector of the blood pump.

Images