CONNECTION SYSTEM FOR TRANSMITTING ENERGY AND/OR DATA FROM AND/OR TO AN IMPLANTABLE BLOOD PUMP, AND VENTRICULAR ASSIST DEVICE

Abstract

The application relates to a connection system for transmitting energy and/or data from and/or to an implantable blood pump. The proposed connection system comprises a first connection unit, which can be or is connected to the blood pump, and a second connection unit, which can be or is connected to a control and/or energy unit. In particular, the first connection unit can be connected to the blood pump by means of an implantable line. The second connection unit can be connected to the control and/or energy unit by means of a transcutaneous line. The first connection unit and the second connection unit can be wirelessly coupled to each other for wireless transmission of energy and/or data. Furthermore, the first connection unit and the second connection unit are implantable, so that both the first connection unit and the second connection unit are designed for use within the body of a patient.

Claims

1. A connection system for transmitting energy and/or data to or from an implantable blood pump, the connection system comprising: a first connection unit connected to the blood pump; a second connection unit connected to a control and/or energy unit, wherein the first connection unit and the second connection unit are wirelessly coupled for wireless transmission of energy and/or data, further wherein the first connection unit and the second connection unit are implantable, so that both the first connection unit and the second connection unit are designed for use within a body of a patient.

2. The connection system according to claim 1, wherein the first connection unit has at least one coil and the second connection unit has at least one coil, wherein the first connection unit and the second connection unit can be inductively coupled to each other via the coils for wireless transmission of energy and/or data.

3. The connection system according to claim 1, wherein the first connection unit has a housing, and the second connection unit has a housing, wherein the housing of the first connection unit and the housing of the second connection unit are liquid-tight and impervious to bodily fluids.

4. The connection system according to claim 1, further comprising: a mechanical connection means by which the first connection unit and the second connection unit can be releasably connected to each other.

5. The connection system according to claim 4, wherein the mechanical connection means establishes a connection between the first connection unit and the second connection unit requiring an action of force of at least 10 N in order to be released.

6. The connection system according to claim 4, wherein the mechanical connection means is a screw closure, a bayonet closure, a detent closure, or a snap-action closure.

7. The connection system according to claim 1, further comprising: a mechanical orientation means, by which the first connection unit and the second connection unit can be oriented relative to each other so that the first connection unit and the second connection unit come to lie in a predefined orientation relative to each other.

8. The connection system according to claim 1, wherein the connection system is designed to transmit wirelessly a power of at least 2 W.

9. The connection system according to claim 1, wherein the first connection unit and the second connection unit have a flat design.

10. The connection system according to claim 1, wherein the first connection unit and the second connection unit have a total height of less than 20 mm when the connection units are in contact.

11. The connection system according to claim 1, wherein the first connection unit and the second connection unit have a diameter of at most 40 mm.

12. The connection system according to claim 1, wherein the first connection unit and the second connection unit have a rounded design for any components that are to be brought into connection with the body.

13. The connection system according to claim 1, wherein the first connection unit and/or the second connection unit is deformable.

14. The connection system according to claim 13, wherein the first connection unit and/or the second connection unit comprises silicone.

15. The connection system according to claim 1, wherein the control and/or energy unit is extracorporeal.

16. A cardiac assist system comprising the connection system according to claim 1; the blood pump; and the control and/or energy unit.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] FIG. 1 shows a schematic view of a cardiac assist system comprising a connection system.

[0031] FIG. 2 shows an arrangement of the connection system beneath the skin of a patient.

[0032] FIG. 3(a) shows one view of the connection system.

[0033] FIG. 3(b) shows another view of the connection system.

[0034] FIG. 3(c) shows another view of the connection system.

[0035] FIG. 4 shows a plan view of coils of a connection unit of the connection system.

DETAILED DESCRIPTION

[0036] FIG. 1 shows schematically a body 1 of the patient, in which a blood pump 2 for assisting the function of the heart 3 is implanted. The blood pump 2 is formed as part of a cardiac assist system and has a motor which is typically embodied as an electric motor with a rotor and which is received in a biocompatible pump housing 4 of the blood pump 2. The pump housing 4 is connected to a control unit 5, which is arranged outside the patient's body and is connected to the blood pump 2 via a transcutaneous line 6. The control unit 5 is additionally connected via two cables 7, 7′ to an energy unit formed as a pair of extracorporeal batteries 8, 8′. The pump housing 4 is connected to an inlet channel 9, via which blood is removed from a chamber of the heart 3, and to a cannula 10, via which blood can be conveyed into a blood vessel 11.

[0037] The control unit 5 is designed to actuate the motor of the blood pump 2 to convey the blood and to supply said motor with energy. In addition, sensor data for example can be transmitted from the blood pump 2 to the control unit 5. For this purpose, the transcutaneous line 6 is connected via an implanted connection system 12, which is arranged in particular fully within the patient's body, to a fully implanted cable 13. The fully implanted cable 13 connects a first connection unit 14 of the connection system 12 to the blood pump 2. The transcutaneous cable 6 passes through the patient's skin at a point of passage 15, i.e. at an opening in the patient's skin, and connects the control unit 15 to a second connection unit 16 of the connection system 12. In order to transmit data and energy with a power of more than 2 W, in particular more than 5 W, the first connection unit 14 is coupled wirelessly to the second connection unit 16. In the shown examples, an inductive coupling is provided, however, in other embodiments a capacitive coupling can also be provided. There are generally no current-conducting connections between the first connection unit and the second connection unit.

[0038] Typically, the connection system 12 is designed to transmit electrical energy, for power supply of the blood pump 2, from the second connection unit 16 to the first connection unit 14. In addition, the connection system 12 is generally designed to transmit electrical signals, for example sensor data or control data, both from the second connection unit 16 to the first connection unit 14 and from the first connection unit 14 to the second connection unit 16. Here, the bodily fluid of the patient can be considered to be a disturbance variable, since the connection system 12 is located fully in the patient's body.

[0039] FIG. 2 shows an arrangement of the connection system 12 beneath the patient's skin. Recurring features are provided in this figure and in the following figures with the same reference signs. Shown is the structure of the body layers and in particular skin layers, comprising the epidermis 17, the dermis 18, the subcutis 19, the fascia 20, and a muscle 21. The connection system 12, during use of the blood pump 2 or of the cardiac assist system, is generally arranged at a distance of approximately 8 to 12 cm from the point of passage 15. The connection system 12 with the connection units 14, 16 is of flat design and arranged such that the direction of its planar extent lies in a layer plane of the body layer. The connection system 12 can be implanted in a skin pocket of the patient. In the shown example, the connection system 12 is arranged in the subcutis, so that the connection system is relatively easily accessible for replacement of the second connection unit 16 and of the transcutaneous line 6 in the case of an infection of the point of passage 15. However, it can also be provided that the connection system 12 is arranged beneath the superficial fascia, so that this forms an additional barrier against infection.

[0040] FIGS. 3(a) to (c) show different views of the connection system 12. The first connection unit 14 and the second connection unit 16 have a housing 22, 23 respectively. Parts of the housing 22, 23 are not shown in FIG. 3(a) in order to show coils 24, 25 accommodated in said housings. One of the coils 24 is to be assigned to the first connection unit 14, whereas a second of the coils 25 is to be assigned to the second connection unit 16. The coils 24, 25 are arranged concentrically one above the other for energy and/or data transmission. In the shown example, the coils are formed without a core. Generally, the coils 24, 25 can be, but do not necessarily have to be, of the same size. In some embodiments a ferrite plate is integrated in order to increase the efficiency.

[0041] As shown in a sectional view in FIG. 3(b), for energy and/or data transmission, the housings 22, 23 of the first and second connection unit 14, 16 lie against each other with contact during use of the connection system 12. The housings 22, 23 are each formed by a biocompatible, elastically deformable silicone body, by which the coils 24, 25 respectively are overmoulded. The housings 22, 23 enclose the coils 24, 25 generally in a manner impervious to bodily fluids and are manufactured from a material resistant to corrosion and hydrolysis, in this case silicone. The housings are free of sharp edges and have a rounded outer side, see for example the end of the second connection unit 16 denoted by reference sign 29. Apart from the lines 6, 13, no parts of the cardiac assist system protrude from the connection units 14, 16.

[0042] A height H of the entire connection system 12 is less than 10 mm when the connection units 14, 16 rest against each other with contact, so that the connection system 12 requires only a small implantation volume. For efficient inductive coupling, a vertical distance of the coils 24, 25 is less than 2 mm when the connection units 14, 16 rest against each other with contact.

[0043] The connection units 14, 16 are additionally mechanically connected to each other and oriented relative to each other so that the coils 24, 25, as shown in FIG. 3(a) to (c), come to lie parallel and concentrically in a defined position relative to each other. For this purpose, the connection system 12 has a mechanical connection means 26, which at the same time serves as an orientation means. In the shown embodiment, the connection means 26 is formed by a detent connection comprising a pair 27, 28 of detent elements engaging in each other. The connection means 26 is formed such that it also holds reliably in the body, wherein an action of force of more than 10 N, for example 20 N can be necessary to release the connection. In respect of the connection means, it can be provided for example that the connection units 14, 16 are secured via threaded sleeves (connection units are screwed to each other), which would be suitable in particular in the case of a hard housing material. Alternatively, a bayonet closure is also a possible connection means.

[0044] FIG. 3(c) shows a plan view of the connection system 12. A diameter D of the coils 24, 25 may for example amount to relatively small 10 or 15 mm. A diameter of the housings 22, 23 is only negligibly larger. In some embodiments, the connection system 12 has a kink protection means at the transition between the line 6 or 13 and the connection unit 14 or 16 respectively in order to prevent a kinking of the lines. A strain relief element and/or a shielding transition can also be provided between the line 6 or 13 and the connection unit 14. In the shown example, the kink protection means is formed by ends of the elastic silicone housing 22, 23 facing the lines 6, 13.

[0045] FIG. 4 shows a pair of concentrically arranged coils 30, 31 according to a further embodiment, which, as described above, can be provided in the housing 22 of the first connection unit 14. In this case, the coil with the reference signs 31 forms a primary coil for energy transmission. The smaller coil with the reference signs 30 forms a secondary coil for simultaneous signal transmission. The second connection unit 16 can have a primary coil and a secondary coil correspondingly.

[0046] Features of the various designs disclosed in the example embodiments can be combined with each other and claimed individually.

[0047] The application relates, amongst other things, to the following embodiments:

[0048] A connection system for transmitting energy and/or data from and/or to an implantable blood pump, the connection system comprising a first connection unit, which can be connected to the blood pump, and a second connection unit, which can be connected to an extracorporeal control and/or energy unit, wherein the first connection unit and the second connection unit can be wirelessly coupled to each other for wireless transmission of energy and/or data, wherein the first connection unit and the second connection unit are implantable, so that both the first connection unit and the second connection unit are designed for use within the body of a patient. The first connection unit has at least one coil and the second connection unit has at least one coil, wherein the first connection unit and the second connection unit can be inductively coupled to each other via the coils for wireless transmission of energy and/or data. The first connection unit has a housing and the second connection unit has a housing, wherein the housing of the first connection unit and the housing of the second connection unit are liquid-tight, in particular impervious to bodily fluids. A mechanical connection means by which the first connection unit and the second connection unit can be releasably connected to each other. The mechanical connection means establishes between the first connection unit and the second connection unit a connection requiring an action a force of at least 10 N, in particular at least 15 N in order to be released. The mechanical connection means is a screw closure, a bayonet closure, a detent closure and/or a snap-action closure. There is a mechanical orientation means, by which the first connection unit and the second connection unit can be oriented relative to each other so that the first connection unit and the second connection unit come to lie in a predefined orientation relative to each other. The connection system is designed to transmit wirelessly a power of at least 2 W, in particular at least 4 W. The first connection unit and the second connection unit have a flat design. The first connection unit and the second connection unit, when these rest against each other with contact, have a total height of less than 20 mm, in particular less than 10 mm. The first connection unit and the second connection unit have a diameter of at most 40 mm, in particular at most 30 mm. The first connection unit and the second connection unit have a rounded design in their components that are to be brought into connection with the body. The first connection unit and/or the second connection unit is deformable. The first connection unit and/or the second connection unit comprises silicone.

[0049] In another embodiment, a cardiac assist system includes a connection system according to one of the preceding embodiments and furthermore includes the blood pump and/or the extracorporeal control and/or energy unit.