EXTERNAL DRIVE UNIT FOR AN IMPLANTABLE HEART ASSIST PUMP
20200390953 ยท 2020-12-17
Inventors
Cpc classification
A61M2205/8262
HUMAN NECESSITIES
A61M60/237
HUMAN NECESSITIES
A61M60/825
HUMAN NECESSITIES
A61M60/13
HUMAN NECESSITIES
A61M60/414
HUMAN NECESSITIES
A61M60/148
HUMAN NECESSITIES
International classification
Abstract
The application relates to an external drive unit (7) for an implantable heart assist pump (4). The proposed drive unit (7) comprises a motor housing (51), a transcutaneous drive shaft (3) and a motor (35) for driving the heart assist pump (4). The motor (35) is connectable to the heart assist pump (4) via the drive shaft (3), and the motor (35) is arranged inside the motor housing (51). The drive unit (7) further comprises a catheter (2) surrounding the drive shaft (3) and a purge line (53) for injecting a purge medium into a lumen of the catheter (2) or into a space (41) between the catheter (2) and the drive shaft (3). The purge line (53) is in thermal contact (54, 55) with an outer surface of the motor housing (51) and/or with an outer surface of a proximal section (52) of the catheter (2). Due to the thermal contact (54, 55) heat may be transferred from the outer surface of the catheter (2) in the proximal section (52) and/or from the outer surface of the motor housing (51) to the purge medium.
Claims
1. An external drive unit for an implantable heart assist pump comprising: a motor housing; a transcutaneous drive shaft; a motor for driving a heart assist pump, wherein the motor is configured to connect to the heart assist pump via the drive shaft and wherein the motor is arranged inside the motor housing; a catheter surrounding the drive shaft; a purge line for injecting a purge medium into a lumen of the catheter or into a space between the catheter and the drive shaft, wherein the purge line is in thermal contact with at least one of an outer surface of the motor housing or an outer surface of a proximal section of the catheter.
2. The drive unit of claim 1, wherein the purge line is configured to guide the purge medium such that: the purge medium first comes into thermal contact with at least one of the outer surface of the motor housing or the outer surface of the proximal section of the catheter, and the purge medium is afterwards injected into the lumen of the catheter or into the space between the catheter and the drive shaft.
3. The drive unit of claim 2, wherein the purge line is in thermal contact with both the outer surface of the motor housing and the outer surface of the proximal section of the catheter.
4. The drive unit of claim 3, wherein the purge line is fully extracorporal.
5. The drive unit of claim 4, wherein the purge line is configured to guide the purge medium such that: the purge medium first comes into thermal contact with the outer surface of the proximal section of the catheter, and the purge medium afterwards comes into thermal contact with the outer surface of the motor housing.
6. The drive unit of claim 1, wherein the motor comprises a stator and a rotatably mounted rotor connected to the drive shaft, wherein a fluid gap is formed between the rotor and the stator, wherein the fluid gap is in fluid connection with a purge opening for injecting the purge medium into the fluid gap, and wherein the purge line is configured to connect to the purge opening.
7. The drive unit of claim 6, wherein the purge line and the fluid gap are configured to guide the purge medium such that: the purge medium first comes into thermal contact with at least one of the outer surface of the motor housing or the outer surface of the proximal section of the catheter, the purge medium is afterwards injected into the fluid gap between the rotor and the stator, and the purge medium is afterwards injected into the lumen of the catheter or into the space between the catheter and the drive shaft.
8. The drive unit of claim 1, wherein the purge line is configured to guide a flow of the purge medium in a proximal direction in an area in which the purge line is in thermal contact with at least one of the outer surface of the motor housing or the outer surface of a proximal section of the catheter prior to injection of the purge medium into the lumen of the catheter or into the space between the catheter and the drive shaft.
9. The drive unit of claim 1, wherein the purge line encircles at least one of the motor housing or the proximal section of the catheter in an area in which the purge line is in thermal contact with at least one of the outer surface of the motor housing or the outer surface of a proximal section of the catheter.
10. The drive unit of claim 9, wherein the purge line runs around at least one of the motor housing or the proximal section of the catheter in a helical manner in the area in which the purge line is in thermal contact with at least one of the outer surface of the motor housing or the outer surface of a proximal section of the catheter.
11. The drive unit of claim 10, wherein the purge line runs around the proximal section of the catheter in a helical manner in the area in which the purge line is in thermal contact with the outer surface of a proximal section of the catheter.
12. The drive unit of claim 1, further comprising a housing of the drive unit, wherein at least one of the motor housing or the proximal section of the catheter are arranged within the housing of the drive unit.
13. The drive unit of claim 1, wherein an overall thermal conductance between an interior surface of the purge line and an interior surface of the motor housing may amount to at least five times an overall thermal conductance between the interior surface of the purge line and an interior surface of the housing of the drive unit.
14. The drive unit of claim 12, wherein a part of the purge line runs between the motor housing and the housing of the drive unit.
15. The drive unit of claim 12, wherein a part of the purge line runs between the proximal section of the catheter and the housing of the drive unit.
16. The drive unit of claim 12, further comprising a thermal insulator arranged between the purge line and the housing of the drive unit.
17. The drive unit of claim 1, further comprising a heat spreader comprising a contact surface configured to contact a skin of a patient, wherein the contact surface is configured to connect with the motor in a thermally-conductive manner to transfer heat generated by the motor to tissue of the patient.
18. The drive unit of claim 17, wherein the heat spreader is flexible at least in an area.
19. A heart assist system comprising: an implantable heart assist pump; and a drive unit comprising: a motor housing; a transcutaneous drive shaft; a motor for driving a heart assist pump, wherein the motor is configured to connect to the heart assist pump via the drive shaft and wherein the motor is arranged inside the motor housing; a catheter surrounding the drive shaft; a purge line for injecting a purge medium into a lumen of the catheter or into a space between the catheter and the drive shaft, wherein the purge line is in thermal contact with at least one of an outer surface of the motor housing or an outer surface of a proximal section of the catheter.
20. The drive unit of claim 13, wherein the overall thermal conductance between an interior surface of the purge line and the interior surface of the motor housing may amount to at least ten times the overall thermal conductance between the interior surface of the purge line and the interior surface of the housing of the drive unit.
Description
[0074] Exemplary embodiments will be described in conjunction with the following figures:
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[0086] A schematic representation of a heart assist device 1 is depicted in
[0087] The heart assist pump 4 as well as the catheter 2 and the drive shaft 3 are inserted into the femoral artery of the patient via a puncture site 8 located in the groin of the patient. The depicted arrangement illustrates the use of the heart assist device 1 to assist the left-ventricular function of the heart, wherein the heart assist pump 4 is partly arranged inside the left ventricle 10 of the patient in an area of the aortic valve 11. When the heart assist device 1 is operated, the drive shaft 3 is driven by the motor of the drive unit 7 and the heart assist device 1 conveys blood from the left ventricle 10 into the aorta 12, i.e., from a distal end 13 of the heart assist device 1 in a direction toward a proximal end 14. In other embodiments, the heart assist device 1 may be configured to convey blood in a direction from the proximal end 14 of the heart assist device 1 toward the distal end 13. Such an arrangement may be particularly suited for assisting a right-ventricular function of the heart.
[0088] The drive unit 7 may be attached to a thigh 15 of the patient, as depicted schematically in
[0089] The drive unit 7 further comprises a heat spreader 19. The heat spreader 19 is rigidly connected with the housing 17 of the drive unit 7 such that heat generated by the motor during operation is transferred to the heat spreader 19. The heat spreader 19 may be thin and have a thickness of 4 mm or less. For example, the heat spreader 19 may be formed by a patch as discussed below or by a flat, two-dimensional heat pipe. A bottom surface of the heat spreader 19 lies flat against and is in direct contact with the skin of the patient in a contact surface so that heat may be transferred from the heat spreader 19 to tissue of the patient. During operation of the motor a temperature of the outer surface of the housing 17 of the drive unit 7 may exceed 43 C. before fixation of the heat spreader 19 to the thigh 15. However, the heat conductivity of the heat spreader 19 ensures that the heat is evenly spread over a sufficient area and transferred into the thigh 15 so that the temperature at the surface of the housing 17 of the drive unit 7 decreases rapidly under a temperature of 42 C., which defines a critical temperature for damaging the tissue.
[0090] The heat spreader 19 comprises regions with a thermal conductivity of more than 100 W/(m.Math.K) to spread the heat laterally so that the heat is efficiently transferred to the entire contact surface. A surface area of the contact surface may be as large as 200 cm.sup.2 in some embodiments. The heat spreader 19 further comprises openings (through holes), two of which are denoted using the reference numerals 20 and 20. The openings 20, 20 allow for a transfer of vaporized sweat to ambient air and hence increase a comfort of wear.
[0091] A perspective view of the drive unit 7 is shown in
[0092] The openings 20, 20 of the heat spreader 19 may be elongated, as schematically depicted in
[0093] The heat spreader 19 may be curved and/or flexible to adapt to a shape of the thigh 15. For example, the heat spreader 19 may comprise a foil or a patch.
[0094] An exemplary cross section through the heat spreader 19 is shown in
[0095] The carrier layer 30 may be formed by an elastomeric and/or plastic material. For an efficient heat transfer across the area of the contact surface, i.e., in a horizontal direction in the figure, the heat spreader 19 further comprises a thin thermally conductive layer 31, which may be formed by a thin layer of a material with a high thermal conductivity, e.g., copper, aluminium or pyrolytic carbon. The thermally conductive layer 31 is enclosed on either side by an inert and biocompatible coating 32 made of parylene, polyurethane, silicone, PEEK, or a biocompatible, for example an implantable metal. The biocompatible coating 32 further covers the thermally conductive layer 31 on inner walls of an opening 20 of the heat spreader 19. A stepless bottom surface of the heat spreader is formed by an adhesive layer 33, e.g., containing glue, to stick the heat spreader 19 to the skin of the patient.
[0096] Further, a sweat absorbent portion 34 of the heat spreader 19 or of the drive unit 7 is schematically depicted in
[0097] A schematic view of the motor 35 is shown in
[0098] The catheter 2 is rigidly connected with the housing 17 of the drive unit 7, and a space 41 is formed between the catheter 2 and the drive shaft 3. This space 41 is in fluid connection with a fluid gap 43 formed between the rotor 36 and the stator 37, with a purge opening 42, and with the supply line 18. A width of the fluid gap 43 in a radial direction may be between 0.2 and 0.3 mm. When the heart assist device 1 is operated, a purge medium, e.g., a glucose solution, is supplied via the supply line 18 and flows through the fluid gap 43 and through the space 41 between the catheter 2 and the drive shaft 3 (and eventually into the patient at a proximal end of the heart assist device 1).
[0099] During operation of the motor 35 a power dissipation of, e.g., 2 W may cause the motor 35 to heat up. The heat is removed from the motor 35 as schematically indicated by the arrow with the reference numeral 44 to keep a temperature of the glucose solution inside the fluid gap 43 constant at 75 C. in a steady state of operation. To remove the heat, the heat may, for example, be transferred to tissue 45 of the patient using the heat spreader 19 as discussed above, to ambient air 46, e.g., using cooling fins on the housing 17 of the drive unit 7, and/or to a heat sink 47 of a console or a controller unit, e.g., via an elongated heat pipe connected to the housing 17 of the drive unit 7. Further, additionally or alternatively, the heat may be transferred to the fluid supply line or purge line as described below. Any combinations of these heat removal mechanisms are possible.
[0100] Further, inductors 50 may be supplied to reduce the eddy-current losses when the motor 35 is not driven in full block commutation. These inductors 50 can also be located inside the housing 17 of the drive unit 7, but in a preferred embodiment the inductors 50 are located at the end of the motor cable 18 which is connected to the controller unit of the motor 35 (or in the controller unit itself) to avoid additional weight and heat sources at the motor 35 and at the patient's leg.
[0101] Heat removal to the purge line is described in conjunction with the following figures.
[0102] An end portion of the purge line 53 is attached to a supply of a purge medium (not shown). The purge line 53 extends into an interior of the housing 17 of the drive unit 7. Inside the housing 17 of the drive unit 7, the purge line 53 lies against an outer surface of the proximal section 52 of the catheter 2. Thereby, a thermal contact between the proximal section 52 of the catheter 2 and the purge line 53 is formed, as indicated by an arrow with reference sign 54. Further, the purge line 53 lies against an outer surface of the motor housing 51. Thereby, a thermal contact between the motor housing 51 and the purge line 53 is formed, as indicated by an arrow with reference sign 55. The purge line 53 is further attached to the purge opening 42. When the purge medium is supplied it flows through the drive unit 7 as indicated by arrows (some of which are marked by reference sign 56). The purge medium first passes the regions of thermal contact 54, 55, then enters the fluid gap 43 and afterwards enters the space 41 between the catheter 2 and the drive shaft 3. In further embodiments, the purge medium enters a lumen of the catheter 2. The purge medium flows mainly in a proximal direction when passing the thermal contacts 54, 55. Later, when the purge medium flows through the fluid gap 43 and the space 41 between the catheter 2 and the drive shaft 3, the purge medium flows in a distal direction.
[0103] During operation of the heart assist pump, the injected purge medium cools the proximal section 52 of the catheter 2 and the motor 35 due to the thermal contacts 54, 55 and due to its comparatively low temperature. Thereby, a section 63 of the catheter 2, which is arranged distally adjacent to the proximal section 52 of the catheter 2 and which is arranged outside of the housing 17 of the drive unit 7 is significantly cooled, such that the section 63 of the catheter 2 that is not arranged inside the housing 17 of the drive unit 7 may be touched without a risk of injury. Further, a risk of deformation of the catheter 2 (and thereby a risk of deformation and failure of the flexible drive shaft 3 arranged inside the catheter 2) due to a heat up of the section 63 of the catheter 2 is reduced. Further, the purge medium is pre-heated due to the thermal contacts 54, 55 prior to entering the fluid gap 43. As a consequence, the purge medium enters the fluid gap 43 with a higher temperature and a lower viscosity, so that friction losses in the motor 35 are reduced and the motor 35 operates more efficiently.
[0104] The motor housing 51 has a cylindrical shape in most embodiments. As shown in
[0105] The drive unit 7 may further comprise a thermal insulation arranged between the purge line 53 and the housing 17 of the drive unit 7 (not shown), so that the housing 17 of the drive unit 7 is prevented from heating up. Further, an efficiency of the heat exchangers formed by the thermal contacts 54, 55 may be improved in this way. The thermal insulation may fully surround the purge line 53 in the regions of thermal contact 54, 55 and may be an insulating foam tube made from a plastic material. The thermal insulation may also be formed by an air gap between the purge line 53 and the housing 17 of the drive unit 7.
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[0108] The purge line 53 enters the housing 17 of the drive unit 7 in a distal section of the housing 17. In addition, the purge line 53 is wrapped around the proximal section 52 of the catheter 2 as well as the motor housing 51 to form the thermal contacts 54, 55, as described above. The purge line 53 is further connected with a proximal end of the motor housing 51 to form the fluid connection with the fluid gap 43 of the motor 35. To further improve the thermal contact of the purge line 53 with the motor housing 51 the purge line 53 is enclosed within a heat-shrink tubing 65 (the position of the purge line 53 underneath the heat-shrink tubing 65 is illustrated using dashed lines). The heat-shrink tubing 65 pushes the purge line 53 against the motor housing 51, thereby improving the thermal contact. The portion of the purge line 53 that is wrapped around the proximal section 52 of the catheter 2 may also be enclosed within a heat-shrink tubing (not illustrated). Further, air gaps 66, 66 are formed between the housing 17 of the drive unit 7 and the portions of the purge line 53 that form the thermal contacts 54, 55 with the motor housing 51 and the proximal section 52 of the catheter 2. The air gaps 66, 66 form a thermal insulation to the motor housing 51 (insulating foam tubes as described above may be alternatively or additionally be provided). Further, the air gaps 66, 66 allow the heat generated by the motor to distribute within the housing 17 to some extent by convection so that local hot spots are avoided.