MEDICAL ASPIRATION SYSTEM AND MEDICAL THROMBECTOMY SYSTEM

Abstract

The invention relates to a medical aspiration system having a catheter with at least two lumens, wherein a first lumen forms an aspiration lumen which is connected to an aspiration unit for suction removal of substances from a blood vessel through an inlet opening in the aspiration lumen, and a second lumen forms an infusion lumen through which a substance can be supplied to the blood vessel through an outlet opening in the infusion lumen, wherein the outlet opening in the infusion lumen is arranged in a region between the inlet opening of the aspiration lumen and a position proximal to the inlet opening in the aspiration lumen. The invention is characterized in that the infusion lumen is connected to a cooling unit, which supplies a cooled liquid for administration through the infusion lumen.

Claims

1. A medical aspiration system having a catheter with at least two lumens, wherein a first lumen forms an aspiration lumen, which is connected to an aspiration unit for suction removal of substances from a blood vessel through an inlet opening in the aspiration lumen, and a second lumen forms an infusion lumen through which a substance can be supplied to the blood vessel through an outlet opening in the infusion lumen, wherein the outlet opening in the infusion lumen is arranged in a region between the inlet opening of the aspiration lumen and a position proximal to the inlet opening in the aspiration lumen, characterized in that the infusion lumen is connected to a cooling unit which supplies a cooled liquid for administration through the infusion lumen.

2. The system according to claim 1, characterized in that the aspiration lumen and the infusion lumen are separated in a fluid-tight manner by a wall without valves.

3. The system according to claim 1, characterized in that the aspiration lumen and the infusion lumen are designed in one piece.

4. The system according to claim 1, characterized in that the region between the inlet opening of the aspiration lumen and the position proximal to the inlet opening in the aspiration lumen amounts to at least 0 cm, in particular at least 5 cm, in particular at least 10 cm, in particular at least 20 cm.

5. The system according to claim 1, characterized in that the region between the inlet opening of the aspiration lumen and the position proximal to the inlet opening of the aspiration lumen amounts to at most 30 cm.

6. The system according to claim 1, characterized in that the length of the catheter amounts to at least 80 cm, in particular at least 90 cm, in particular at least 100 cm, in particular at least 110 cm.

7. The system according to claim 1, characterized in that the diameter of the catheter amounts to at least 7 Fr, in particular at least 8 Fr.

8. The system according to claim 1, characterized in that the diameter of the catheter amounts to at most 11 Fr, in particular at most 10 Fr, in particular at most 9 Fr.

9. The system according to claim 1, characterized in that the cross-sectional area of the infusion lumen is between 0.16 mm2 and 0.4 mm2, in particular between 0.16 mm2 and 1 mm2, in particular between 0.2 mm2 and 0.8 mm2, in particular between 0.3 mm2 and 0.6 mm2.

10. The medical aspiration system having a catheter with a single lumen, which is connected to at least two separate units by a switchable valve, wherein a first unit is fluidically connected to the lumen in a first switch position of the valve, and a second unit is fluidically connected to the lumen in a second switch position of the valve, wherein the first unit comprises an aspiration unit for suction removal of substances from a blood vessel, and the second unit comprises a cooling unit for supplying cooled liquid into the blood vessel.

11. The set with a system according to claim 10 and a medical instrument, which is or can be positioned longitudinally displaceably inside the lumen.

12. The medical aspiration system having a catheter with at least two lumens, wherein a first lumen forms an aspiration lumen, which is connected to an aspiration unit for suction removal of substances from a blood vessel through an inlet opening in the aspiration lumen, and a second lumen forms an infusion lumen, through which a substance can be supplied to the blood vessel through an outlet opening in the infusion lumen, wherein the outlet opening in the infusion lumen is arranged in a region between the inlet opening of the aspiration lumen and a position proximal to the inlet opening in the aspiration lumen, characterized in that the infusion lumen is connected to an infusion device which supplies a liquid, in particular a cooled liquid for administration through the infusion lumen.

13. The medical cooling system having a catheter with at least two lumens, wherein a first lumen forms an instrument lumen for supplying a medical instrument, in particular a thrombectomy device, and a second lumen forms an infusion lumen through which a substance can be supplied to the blood vessel through an outlet opening of the infusion lumen, wherein the outlet opening of the infusion lumen is arranged in a region between the inlet opening of the instrument lumen and a position proximal to the inlet opening of the instrument lumen, characterized in that the infusion lumen is connected to a cooling unit which supplies a cooled liquid for administration through the infusion lumen.

14. The set with a system according to claim 13 and a medical instrument, which is or can be positioned longitudinally displaceably inside the instrument lumen.

15. The set with a medical cooling system having a catheter with a single lumen which is connected to a cooling unit for supplying cooled liquid into a blood vessel and has a valve, in particular a hemostatic valve, proximally to an outlet opening in the lumen, wherein a function catheter for supplying a medical instrument or for aspiration is or can be positioned longitudinally displaceably in the lumen such that an annular space for supplying the cooled liquid remains between the catheter and the function catheter.

16. The set according to claim 15, characterized in that the function catheter has a greater length than the catheter.

17. The set according to claim 15, characterized in that the outlet opening in the lumen is arranged in a region between a distal inlet opening in the function catheter and a position proximal to the inlet opening in the lumen.

18. The system according to claim 13, characterized in that the at least two lumens of the catheter are arranged longitudinally displaceably, one inside the other, in particular coaxially one inside the other.

19. The system according to claim 18, characterized in that the aspiration lumen or the instrument lumen is arranged coaxially inside the infusion lumen.

Description

[0041] The invention is explained in greater detail below on the basis of schematic drawings with additional details, in which:

[0042] FIG. 1 shows a two-lumen catheter in a blood vessel upstream from a thrombus in which aspiration is being performed and a transfusion is being administered at the same time;

[0043] FIG. 2 shows a longitudinal section through the catheter according to FIG. 1;

[0044] FIGS. 3a, 3b, 3c show a cross section through various embodiments of a two-lumen catheter suitable for the invention;

[0045] FIG. 4 shows a longitudinal section through a catheter according to another inventive exemplary embodiment; and

[0046] FIG. 5 shows a cross section through a catheter according to another inventive exemplary embodiment.

[0047] FIG. 1 shows the catheter 1 of a medical aspiration system according to an inventive exemplary embodiment during treatment. The catheter 1 is therefore inserted into a blood vessel. The tip of the catheter is situated directly upstream from the thrombus to be removed from the blood vessel. The catheter 1 has two lumens. The first lumen forms an aspiration lumen 2 which is connected to an aspiration unit for aspiration of the thrombus (not shown). The aspiration unit may be a suction device or a syringe. The second lumen is an infusion lumen 3, through which a substance, for example, a cooled liquid, is supplied to the blood vessel. The infusion lumen 3 is connected to a function unit (not shown), which is designed as a cooling unit.

[0048] As shown in FIG. 2, the infusion lumen 3 has an outlet opening 4 and the aspiration unit has an inlet opening 5. The outlet opening 4 and the inlet opening 5 are formed in the area of the distal catheter tip for aspiration of the thrombus, which is arranged during use in the blood vessel. In concrete terms the openings 4, 5 open into the tip of the catheter. In the exemplary embodiment according to FIG. 2, the outlet opening 4 and the inlet opening 5 are arranged at the same height. This means that the two openings 4, 5 are essentially arranged in the same plane. This arrangement forms the distal maximal position that can be assumed by the outlet opening 4 of the infusion lumen 3 based on the inlet opening 5 in the aspiration lumen 1 (distance=0 cm). In deviation from the embodiment illustrated in FIG. 2, the outlet opening 4 may be arranged so that it is set back in the proximal direction so that it is a distance away from the inlet opening 5 in the proximal direction. The greater the distance between the inlet opening 5 and the outlet opening 4, the less cooled fluid is removed through the inlet opening 5.

[0049] Furthermore, the probability that the cold infusion will flow into side vessels and branches is then greater. The distance between the two openings 4, 5 should be no more than 30 cm in order for the cooling effect to be retained in the area of the inlet opening 5.

[0050] The aspiration system allows simultaneous aspiration of the thrombus and cooling of the vessel. This is indicated by the large and small arrows in the catheter. The large arrows pointing in the proximal direction illustrate the suction flow created by the vacuum produced by the aspiration unit. The suction flow results in the thrombus in the blood vessel being sucked into the catheter, specifically into the aspiration lumen 2 of the catheter 1. At the same time a substance is administered to the blood vessel. The substance stream to be administered is illustrated by the smaller arrows pointing in the distal direction. The substance flow is produced by a function unit (not shown) which generates an excess pressure conveying the substance into the blood vessel.

[0051] The aspiration and the infusion need not necessarily take place at the same time. The infusion can be interrupted during the aspiration. Even if the infusion and the aspiration do not take place at the same time, the present embodiment has the advantage over the prior art that both phases, i.e., the phase of aspiration and the phase of infusion, can be carried out with one and the same catheter in rapid alternation in time without the need for changing catheters.

[0052] Preferably only aspiration is performed through the aspiration lumen. In order to prevent infusion medium from being supplied through the aspiration lumen, the aspiration lumen may be connected only to the aspiration unit. If the aspiration system is handled cautiously accordingly, it is also possible to provide the aspiration lumen with two connections, a first connection being connected to an aspiration unit, and a second connection being connected to an infusion unit. In this case, it is possible to administer contrast medium, for example, through the aspiration lumen, so that cold infusion still flows in the infusion lumen without being influenced. The infusion unit in this case is a syringe, for example. If the infusion takes place only before the aspiration, for example, then there is no risk that pieces of thrombi in the aspiration lumen will be flushed out.

[0053] The cooling unit is a cooling system, in which the cooling of the liquid and the creation of the pressure for conveying the liquid take place. Instead of the cooling system, it also possible to use a simple cooled bag, filled with the liquid to be administered.

[0054] Instead of a cooling agent, a lysis medium or a contrast medium can also be administered during the aspiration. The supply unit may then be a simple syringe.

[0055] FIG. 2 shows a longitudinal section through the catheter according to FIG. 1, wherein the larger diameter of the aspiration lumen 2 is readily apparent in comparison with the infusion lumen 3.

[0056] FIGS. 3a, 3b, 3c show different variants of the catheter 1 according to FIG. 1. In the variant according to FIG. 3a, the aspiration lumen 2 and the infusion lumen 3 are arranged eccentrically. This is also true of the variants according to FIGS. 3b, 3c. With the variant according to FIG. 3a, the aspiration lumen 2 and the infusion lumen 3 are each designed with a circular cross section. In variant 3b, the infusion lumen 3 is characterized by a wall that is flexible in some sections. During use, i.e., when the infusion lumen 3 is acted upon with a liquid and/or with pressure, the cross section of the infusion lumen 3 opens up automatically. Alternatively, the wall shown in FIG. 3b with the geometry illustrated there is stable, i.e., it is difficult or impossible to deform.

[0057] In the variant according to FIG. 3c the infusion lumen 3 has an oval cross section. The infusion lumen 3 is integrated into the wall of the aspiration lumen 2. It is also possible for the aspiration lumen 2 to be round and for the infusion lumen 3 to be arranged completely outside of the aspiration lumen 2. A sickle-shaped cross section may also be possible here. The outside profile may be round or may have a protrusion.

[0058] The drawings illustrate the feature wherein the access opening of the infusion lumen 3 is arranged at least at the same height as the access opening in the larger aspiration volume 2. Alternatively, the access opening in the infusion lumen 3 may be arranged further proximally than the access opening in the aspiration lumen 2.

[0059] In this case, the infusion lumen 3 may have a lateral opening and/or an outlet opening 4 as shown in FIG. 4. This may be a simple hole in the outside wall of the catheter. The infusion lumen 3 may be closed in the distal area, for example, by adhesive bonding without altering the profile of the aspiration lumen 2. Alternatively, the aspiration lumen 2 may be larger at the distal end from the opening of the infusion lumen and/or may have a larger cross section because the contour of the infusion lumen 3 (which protrudes inwardly) is no longer present or has a smaller profile. Examples: a two-lumen extrusion and/or a two-lumen tube or at least one extrusion or a corresponding tube having an infusion lumen 3 extends in the proximal region as far as the opening 4 in the infusion lumen 3. Beyond the opening 4, the proximal area is connected to a single lumen extrusion or a corresponding tube or at least one infusion lumen-free extrusion and/or a corresponding tubing. It may happen that the proximal area develops into the distal area. This is possible, for example, when the infusion lumen 3 is pressed outward with a mandrel and with corresponding simultaneous heating. It is then possible for a portion of the profile of the infusion lumen 3 to remain and to protrude inward. It is also possible for the aspiration lumen 2 to remain unchanged and for the outside diameter to be reduced due to the reduction in or disappearance of the infusion lumen 3 distally from the opening in the outside diameter. This is logical in particular in the version with a separate reinforcement of the aspiration lumen 2. In this case the infusion lumen 3 does not protrude inward into the aspiration lumen 2.

[0060] Instead the infusion lumen 3 is outside of the reinforcement. In this case, the lumen can be closed by a thermal process, for example, by shrinkage, which would reduce the outside diameter of the catheter. Either the cross-sectional area of the aspiration lumen 2 is increased or the outside diameter of the catheter is reduced distally from the opening in the infusion lumen 2 or both. Alternatively, the two remain unchanged.

[0061] The length of the catheter may be at least 70 cm, in particular at least 80 cm, in particular at least 90 cm (position in the ACC, common carotid artery). Alternatively, the catheter may have a length of at least 90 cm, in particular at least 100 cm, in particular at least 110 cm, in particular at least 120 cm, in particular at least 130 cm, in particular at least 140 cm (position in the ACIinternal carotid artery, MCAmiddle cerebral artery). The diameter of the catheter may be at least 7 Fr, in particular at least 8 Fr, at most 11 Fr, in particular at most 10 Fr, in particular at most 9 Fr (position in the ACC). Alternatively, the catheter may have a diameter between 5 and 7 Fr, preferably 6 Fr (position in the ACI, MCA).

[0062] The inside diameter of the aspiration lumen 2 is approx. 300 m less than the outside diameter. This refers to the outside diameter of the entire catheter. The wall in the area of the lower limit amounts to 300 m. In particular the difference is between 200 and 1200 m, in particular between 300 and 1000 m, in particular between 400 and 800 m.

[0063] The flow cross section of the aspiration lumen 2 is reduced accordingly by the infusion lumen 3, which protrudes partially or completely into the aspiration lumen 2. With the small dimensions of the catheter 1, in particular the infusion lumen 3, however, the aspiration is not impaired significantly.

[0064] Alternatively, the infusion lumen 2 does not protrude into the aspiration lumen 3 as shown in FIG. 5. Instead, both lumens 2, 3 are arranged at the side and in the best case are round. The lumens are enclosed by a round outside profile. In the preferred case, a reinforcement is arranged around each lumen 2, 3. It is possible for the reinforcement to be arranged around only the aspiration lumen 2 or only the infusion lumen 3. A variant without reinforcement is also possible.

[0065] The infusion lumen 3 is at most large enough that a catheter of at least 3 Fr, in particular at least a 4 Fr catheter can be transported through the aspiration lumen 2 (for positioning in the ACI/MCA). The remaining aspiration volume 2 in the ACC should be designed for supply of a 5 Fr or 6 Fr catheter. For the posterior cerebral circulation (vertebral artery and basilar artery) the same dimensions are conceivable as those for placement in the ACI.

[0066] The cross-sectional area of the infusion lumen 3 may be between 0.16 mm.sup.2 and 0.4 mm.sup.2. In particular the lumen may have a diameter between 0.16 mm.sup.2 and 1 mm.sup.2, in particular between 0.2 mm.sup.2 and 0.8 mm.sup.2, in particular between 0.3 mm.sup.2 and 0.6 mm.sup.2.

[0067] In general, a combination of the aspiration lumen with balloon cooling is possible. This means that the catheter has more than two lumens, for example, four or five lumens. However in the optimal case the catheter has exactly two lumens. Therefore, the dimensions of the catheter can be miniaturized so that a good aspiration is possible in small intracranial vessels.

[0068] The combination of the aspiration system with an occlusion balloon 6 is also possible. The occlusion balloon 6 has good compliance with the vascular wall.

[0069] The occlusion balloon 6 may be positioned proximally to both openings 4, 5 when both openings 4, 5 are arranged at the same level at the tip of the catheter. If the opening 4 in the infusion lumen is arranged proximally, then the occlusion balloon 6 may be situated in between. It is therefore possible for the cold infusion not to be aspirated as all during the aspiration and to flow in collateral vessels located proximally. Alternatively, the proximally located opening 4 may also be arranged distally to the occlusion balloon 6 if it is necessary for the cooling to also flow distally during the occlusion.

[0070] In deviation from FIG. 2, the infusion lumen 3 can also end further proximally. The aspiration lumen 2 is therefore more flexible at the distal end. A distal reduction in the outside diameter, in particular in the case of the proximal opening in the infusion lumen 3 is also possible. The aspiration lumen 2 may retain the same dimension. In other embodiments with an opening at the same level, a reduction in the outside diameter is also possible.

[0071] The aspiration system allows the use of hypertonic solutions as well as cold liquid to reduce the edema. Medications of all types can be administered through the infusion lumen 3. The aspiration unit may have a system with a pressure unit, i.e., a pump or a syringe.

[0072] The aspiration lumen 2 may be used to supply a recanalization device and/or a thrombectomy unit. In conjunction with the inventive aspiration system and all the exemplary embodiments of this patent application, therefore, the combination of the catheter 1 with a recanalization device and/or a thrombectomy unit is also disclosed and claimed as an additional exemplary embodiment.

[0073] Alternatively, the aspiration lumen 2 may be used to supply a microcatheter with a self-expanding thrombectomy element or a self-expandable recanalization element. In conjunction with the inventive aspiration system and all the exemplary embodiments of this patent application, therefore the combination of the catheter 1 with an additional aspiration catheter is disclosed and claimed as an additional exemplary embodiment, for example, in the form of a set with or without additional self-expanding recanalization device. The additional aspiration catheter may have a size of 5 Fr or 6 Fr or the like. The recanalization device and/or the thrombectomy element may be arranged therein.