CURVED SENSORIZED CATHETER

Abstract

The present disclosure generally relates to the field of catheter technology. More specifically, the present disclosure relates to a catheter and to a catheter system comprising a catheter and a medical device to be introduced into the catheter. An embodiment of a catheter comprises: an elongated body comprising a distal tip; a lumen arranged within the elongated body and comprising a lumen opening arranged at the elongated body; and one or more sensors laterally arranged at the elongated body. The elongated body comprises an at least partially curved portion and at least one of the one or more sensors is arranged at the at least partially curved portion.

Claims

1-15. (canceled)

16. A catheter comprising: an elongated body comprising a distal tip; a lumen arranged within the elongated body and comprising a lumen opening arranged at the elongated body; and one or more sensors laterally arranged at the elongated body; wherein the elongated body comprises an at least partially curved portion and at least one of the one or more sensors is arranged at the at least partially curved portion, wherein the at least one of the one or more sensors is arranged, in the longitudinal direction of the elongated body, at the same position as the lumen opening and is arranged, in circumferential direction of the elongated body, at a different position than the lumen opening.

17. The catheter of claim 16, wherein the lumen opening comprises or is configured as a lateral lumen opening laterally arranged at the elongated body proximal to the distal tip of the elongated body.

18. The catheter of claim 16, wherein the lumen opening is arranged at the at least partially curved portion; and/or wherein the one or more sensors comprise or are configured as at least one of one or more flow sensors and one or more ultrasound sensors.

19. The catheter of claim 16, wherein the at least partially curved portion comprises a straight section, and the lumen opening and/or the at least one of the one or more sensors is/are arranged at the straight section of the at least partially curved portion.

20. The catheter of claim 16, wherein the at least partially curved portion comprises a rounded section, and the lumen opening and/or the at least one of the one or more sensors is/are arranged at the rounded section of the at least partially curved portion.

21. The catheter of claim 16, wherein the elongated body comprises a straight portion, and the lumen opening is arranged at a position that is distanced from the straight portion in a direction perpendicular to the longitudinal direction of the straight portion.

22. The catheter of claim 16, wherein the catheter comprises an adjusting component configured to adjust the shape of the at least partially curved portion, e.g., a radius of the at least partially curved portion.

23. The catheter of claim 16, wherein the catheter comprises at least one second lumen within the elongated body; and/or wherein the catheter comprises a slide within the lumen, the slide being configured to extend towards the lumen opening.

24. The catheter of claim 16, wherein the at least one of the one or more sensors is configured to determine the location of an anatomical region or structure.

25. The catheter of claim 24, wherein the anatomical region or structure comprises or is a side branch of a vessel, a stenosis of a vessel, or a heart valve.

26. The catheter of claim 16, wherein the at least one of the one or more sensors is configured to detect blood flow changes in a vessel into which the catheter is inserted and to derive the location of an anatomical region or structure from the detected blood flow changes.

27. The catheter of claim 16, wherein the catheter comprises a control unit, wherein the control unit is configured to determine a location and/or positioning of the catheter at which the lumen opening is aligned with the location of an anatomical region or structure based on an output of the at least one of the one or more sensors, for example the control unit is configured to determine the location and/or positioning of the catheter at which the lumen opening is aligned with the location of an orifice of a side branch of a vessel or at which the lumen opening faces the center of a heart valve based on an output of the at least one of the one or more sensors.

28. The catheter of claim 16, wherein, when the catheter is introduced into a vessel, the portion of the catheter on which the lumen opening and/or the at least one of the one or more sensors is/are arranged is deviated from the center of the vessel in a direction perpendicular to the longitudinal direction of the vessel.

29. A catheter system comprising: the catheter of claim 16; and a medical device that is configured to be introduced into the lumen of the catheter.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In the following, the present disclosure will further be described with reference to exemplary embodiments illustrated in the Figures, in which:

[0037] FIG. 1 is a schematic illustration of a prior art catheter;

[0038] FIG. 2 is a schematic illustration of another prior art catheter;

[0039] FIG. 3a is a schematic illustration of a catheter according to a first embodiment;

[0040] FIG. 3b is a schematic illustration of the catheter according to the first embodiment at a different position;

[0041] FIG. 4 is a schematic illustration of a catheter according to a second embodiment;

[0042] FIG. 5 is a schematic illustration of a catheter according to a third embodiment;

[0043] FIG. 6 is a schematic illustration of the catheter according to the first embodiment of FIGS. 3a and 3b;

[0044] FIG. 7 is a schematic illustration of a variant of the catheter according to the first embodiment of FIGS. 3a and 3b;

[0045] FIG. 8 is a schematic illustration of the catheter according to the first

[0046] FIG. 9 is a schematic illustration of a flow mapping in the region of a side branch;

[0047] FIG. 10 is a flow mapping of an anatomical mockup; and

[0048] FIG. 11 is a schematic illustration of a diagram of measured flow velocity.

DETAILED DESCRIPTION

[0049] In the following description, for purposes of explanation and not limitation, specific details are set forth, such as specific catheter shapes or sensor details, in order to provide a thorough understanding of the present disclosure. It will be apparent to one skilled in the art that the present disclosure may be practiced in other embodiments that depart from these specific details. For example, even if the present disclosure is described with reference to specific catheter shapes or sensors, the present disclosure may be practiced with other catheter shapes or sensors. That is, even if in the below it is referred only to one or more flow sensors, other types of sensors such as ultrasound sensors may be used in addition or instead.

[0050] FIG. 1 shows a schematic illustration of a prior art catheter 1. The prior art catheter 1 shown in FIG. 1 is often referred to as Bernstein catheter. The catheter 1 is of a bent tip type, as its distal end portion close to the distal tip 2 is bent. In the example of FIG. 1, the catheter 1 is introduced into a vessel 30. In the example shown in FIG. 1, a straight potion 1a of the elongated body of the catheter 1 lies on the center 32 of the vessel 30 and the tip portion of the catheter 1 is bent towards the wall 33 of the vessel 30. Further, a side branch 34 of vessel 30 is shown in FIG. 1. The side branch 34 of the vessel 30 has a center 36. In order to perform a certain operation at or close to the side branch 34, the catheter 1 has to be brought close to the side branch 34, for example the distal tip 2 has to be aligned with the center 36 of the side branch 34. In consequence, the distal tip 2 of the catheter 1 may damage the side branch 34 or may cause any other trauma.

[0051] FIG. 2 shows a schematic illustration of another prior art catheter 1. The catheter 1 is also introduced into a vessel 30 similar to the one shown in FIG. 1. Thus, regarding the details of the vessel 30 and the side branch 34 it is referred to FIG. 1 above. As can be seen from FIG. 2, the catheter 1 is also bent. The distal tip 2 of catheter 1 has a certain angulation in order to engage the center 36 of side branch 34. However, when the distal tip 2 is getting close to or contacts the side branch 34, there is a risk of damaging the side branch 34 or causing any other trauma.

[0052] FIGS. 3a and 3b show a catheter 10 according to a first embodiment. The catheter 10 is also introduced into a vessel 30 similar to the ones shown in FIGS. 1 and 2.

[0053] Thus, regarding the details of the vessel 30 and the side branch 34 it is referred to FIGS. 1 and 2 above. The catheter 10 of FIG. 3a is identical to the catheter 10 of FIG. 3b, it is just positioned at a different location within the vessel in FIGS. 3a and 3b.

[0054] Unlike the prior art catheters 1 of FIGS. 1 and 2 the catheter 10 according to the first embodiment is equipped with a flow sensor 12. Although only one flow sensor 12 is shown in FIGS. 3a and 3b, the catheter 10 may include any number of flow sensors 12, i.e. one or more flow sensors 12. In the following, it will only be referred to the flow sensor 12 without limiting the number of flow sensors 12 to any specific number. The flow sensor 12 may be a flow velocity sensor. For example, the flow sensor 12 may be configured as a thermo-convective sensor as will be described in more detail below. The catheter 10 further comprises an opening 14 or hole that is part of or connected to a lumen within the catheter 10. The opening 14 is therefore referred to as lumen opening 14. The lumen opening 14 is arranged at the side of the elongated body of the catheter, i.e. the opening 14 is arranged laterally at the elongated body. Thus, the lumen opening 14 may also be referred to as lateral lumen opening 14. There may be one or more openings 14 arranged at the catheter 10. A medical device 16 such as a guide wire, guide catheter, balloon catheter or the like may be introduced into the lumen of the catheter 12 and may exit from the catheter 10 through the lumen opening 14. In general, a catheter adapted for guiding a medical device, inserted into the catheter, to a certain location, may be referred to as guiding catheter.

[0055] The catheter 10 according to the first embodiment includes an at least partially curved portion 18 (that may also be referred to as at least partially bent portion). The at least partially curved portion 18 may be understood as a portion of the elongated body of the catheter 10 that is bent with respect to the straight portion 10a of the catheter 10 and that has one or more bent or curved portions or sections. In other words, at least a part of the at least partially curved portion 18 is bent or curved with respect to the straight portion 10a of the elongated body of the catheter 10. In the exemplary shape shown in FIGS. 3a and 3b, the at least partially curved portion 18 comprises a first curved section 18a (bent section 18a) that is bent away from the straight portion 10a of the catheter 10 and a second curved section 18b (bent section 18b) that is bent back (in a direction back to the straight portion 10a of the catheter 10). A straight section 18c is arranged between the two curved sections 18a and 18b. Thus, in the exemplary configuration of FIGS. 3a and 3b, the at least partially curved portion 18 comprises a first curved section 18a, a straight section 18c and a second curved section 18b. Further, in the exemplary configuration of FIGS. 3a and 3b, the flow sensor 12 and the lumen opening 14 are arranged at the straight section 18c of the at least partially curved portion 18. The first curved section 18a and the second curved section 18b do not necessarily have to be curved along their whole length, as long as at least a part of the first curved section 18a and the second curved section 18b is curved such that the at least partially curved portion 18 is bent with respect to the straight portion 10a of the catheter 10.

[0056] The at least partially curved portion 18 of the catheter 10 having the flow sensor 12 is deviated from the center 32 of the vessel 30 in a direction perpendicular to the longitudinal direction of the straight portion 10a. Thus, it can bring the flow sensor 12 closer to the vessel's wall 33 without damaging the vessel's wall. Further, the opening 14 can be brought close to the side branch 34 without any sharp edge such as the tip of the catheter damaging the side branch 34. The flow sensor 12 can recognize when the center 36 of the side branch 34 is reached. In accordance therewith, the catheter 10 can be placed such that the flow sensor 12 and/or the lumen opening 14 is aligned with the center 36 of the side branch 34. The latter is shown in FIG. 3b. In other words, looking at the flow (velocity) signal determined by the flow sensor 12, it is possible to identify when the flow sensor 12 together with the opening 14 is aligned with the center 36 of the side branch orifice of the side branch 34.

[0057] Aligning the flow sensor 12 and/or the opening 14 with the center 36 of the side branch 34 may be achieved in various ways. For example, when the catheter 10 is moved in the proximity of the side branch 34 the flow changes. The change can be magnitude, direction or sense or a combination of the three quantities. Changes in the magnitude of the flow can be measured by the flow sensor 12 in that there is an increase when there is a striction and a decrease when there is a widening, e.g. in the case of the stenotic valve an increase of flow velocity is measured when approaching the leaflets' commissure. In the case of the side branch 34 the flow velocity direction deviates from a direction along the vessel's longitudinal direction to a direction more perpendicular to this first one. The sense changes in the direction of the side branch 34, i.e. left or right side branch.

[0058] Due to the shape of the catheter 10, the sensor 12 is brought in a region of the vessel where there is a difference between two flow velocities measured: when the sensor 10 is scanning the region close to the vessel's wall (FIG. 3a), and/or when it is facing the orifice of the side branch (FIG. 3b). This difference is used for the identification of the anatomical location.

[0059] In the exemplary configuration of FIGS. 3a and 3b, the flow sensor 12 and the opening 14 are arranged at the same position along the elongated body of the catheter 10 but at a different position along the circumference of the elongated body. Thus, by aligning the flow sensor 12 with the center 36 of the side branch 34, the opening is automatically aligned with the center 36 of the side branch 34. If the flow sensor 12 and the opening are distanced from each other by a predetermined distance along the longitudinal direction of the elongated body of the catheter 10, the control unit may consider this predetermined distance in order to align the opening 14 with the center 36 of the side branch from measurement signals of the flow sensor 12.

[0060] As the lumen opening 14 is arranged at the at least partially curved portion 18, more particularly at the straight section 18c of the at least partially curved portion 18, the side branch 34 is not damaged when the catheter 10 approaches or is positioned close to the side branch 34 or even contacts the side branch 34.

[0061] FIG. 4 shows a schematic illustration of a catheter 10 according to a second embodiment. The catheter 10 is also introduced into a vessel 30 similar to the ones shown in FIGS. 1 to 3b. Thus, regarding the details of the vessel 30 and the side branch 34 it is referred to FIGS. 1 to 3b above.

[0062] The catheter 10 according to the second embodiment of FIG. 4 only differs from the catheter 10 according to the first embodiment of FIGS. 3a and 3b in the shape of the at least partially curved portion 18. All other details may correspond to each other or may at least be similar. The at least partially curved portion 18 of the catheter 10 according to the second embodiment is curved in an almost circular manner to form at least a half circle. The flow sensor 12 and the opening 14 are arranged at a round section of the at least partially curved portion 18. Other geometries and shapes than the one shown in FIGS. 3a to 4 are possible for the catheter's geometry.

[0063] The at least partially curved portion 18 of the catheter 10 having the flow sensor 12 is deviated from the center 32 of the vessel 30 in a direction perpendicular to the straight portion 10a of the elongated body of the catheter 10. Thus, the flow sensor 12 and the opening 14 can be brought closer to the vessel's wall 33 without causing any damage, harm or trauma. The flow sensor 12 can recognize when the center 36 of the side branch 34 is reached. In accordance therewith, the catheter 10 can be placed such that the sensor 12 and/or the lumen opening 14 is aligned with the center 36 of the side branch 34. The latter is shown in FIG. 4. In other words, looking at the flow (velocity) signal determined by the flow sensor 12, it is possible to identify when the sensor 12 together with the opening 14 is aligned with the center 36 of the side branch orifice of the side branch 34. If the flow sensor 12 and the opening 14 are distanced from each other, this distance can be considered for aligning the opening 14 with the center 36 of the side branch 34 as mentioned above.

[0064] As the lumen opening 14 is arranged at the at least partially curved portion 18, more particularly at a rounded section of the at least partially curved portion 18, the side branch 34 is not damaged when the catheter 10 approaches or is positioned close to the side branch 34 or even contacts the side branch 34.

[0065] The flow sensor 12 of any of the embodiments described herein can provide deterministic information on the position of the anatomical location such as the side branch 34. This means that the catheter 10 does not have to engage mechanically with the anatomical location but instead, thanks to the sensor measurement(s), can be aligned to the opening of the side branch 34 facilitating the engagement with the opening. In this way, the anatomical position is identified not with a trial an error process trying to hit the target but with a more deterministic approach. Once the catheter 10 is correctly aligned with the side branch 34 another medical device can be advanced through the opening 14.

[0066] The same or a similar type of catheter 10 can be used also for identifying the center 42 of a heart valve 40 as shown in FIG. 5. The flow sensor 12 is able to identify when the catheter's opening 14 is facing the center 42 of the valve 40. In this way, a second device like a guide wire can be approached easily through the valve's leaflets.

[0067] FIG. 5 shows a schematic illustration of a catheter 10 according to a third embodiment. The catheter 10 is also introduced into a vessel 30 similar to the ones shown in FIGS. 1 to 4. Thus, regarding the details of the vessel 30 it is referred to FIGS. 1 to 4 above. In contrast to FIGS. 3a to 4 above, an aortic valve 40 is shown and the lumen opening 14 is to be aligned with the center 42 of the valve 40.

[0068] The catheter 10 is equipped with a flow (velocity) sensor 12. By means of the flow (velocity) sensor 12 the higher flow coming from the center 42 of the aortic valve 40 can be found, being the valve stenotic or not. Once the opening 14 is aligned with the center 42 of the valve 40, a medical device can be approached out of the opening 14 to the valve.

[0069] The shape of the at least partially curved portion 18 is similar to the one of the catheter 10 according to the second embodiment shown in FIG. 4. However, the flow sensor 12 and the opening 14 are positioned at a different location on the at least partially curved portion 18.

[0070] As the lumen opening 14 is arranged at the at least partially curved portion 18, more particularly at a rounded section of the at least partially curved portion 18, the aortic valve 40 is not damaged when the catheter 10 approaches or is positioned close to the side branch 34 or even contacts the side branch 34.

[0071] Summarizing the above, the catheter 10 of all embodiments has an elongated body with a particular (at least partially curved) shape. In the exemplary examples of FIGS. 3a to 5 this particular shape is provided at the distal part (proximal part is the section that remains outside the body, while distal is the opposite). The present disclosure is, however, not limited to the particular shape being at the distal part. The particular shape allows the sensor 12 to get close to the side wall 33 of the vessel 30 as shown in FIGS. 3a to 4. A lateral lumen opening 12 is present on the catheter shaft, the lateral lumen opening 14 is connected to an inner lumen that is used to insert a medical device (e.g. a guide wire). In contrast to prior art catheters 1 in which the opening is placed on the distal tip 2, there is no sharp edge in contact with the vessel's wall 33 in the embodiments described with respect to FIGS. 3a to 5, but only the catheter's body, with the result of being less traumatic.

[0072] The catheter 10 may comprise an adjusting component for adjusting the shape of the catheter, for example for adjusting the shape of the at least partially curved portion 18. For example, the catheter's curvature can be actively changed by means of the adjusting component. The adjusting component may comprise a system of wire. By operating the wires, the catheter section holding the sensor 12 may be placed closer or more distant from the side branch 34 or the aortic valve 40, for example.

[0073] FIG. 6 schematically illustrates a catheter system comprising a catheter 10 according to the first embodiment and a medical device 16. The catheter of FIG. 6 has a flow sensor 12 and an opening that can be used for approaching a second medical device. As can be seen in FIG. 6, the medical device 16 exits the catheter 10 at the lateral lumen opening 14 that is arranged laterally at the at least partially curved portion 18 of the catheter 10 according to the first embodiment.

[0074] FIG. 7 schematically shows a variant of the catheter 10 according to the first embodiment. FIG. 7 shows a catheter having two lumens 22, 24 for inserting two medical devices such as two guide wires or two different medical devices having, for example, different diameter. In other words, according to this variant, two lumens 22, 24 are arranged within the catheter 10. A first lumen is configured to accommodate a first medical device and the second lumen 24 is configured to accommodate a second medical device. The diameter of the cross-section through the first lumen 22 and the second lumen 24 may differ from each other. For example, the diameter of the cross-section of the first lumen 22 may be larger than the diameter of the cross-section of the second lumen 24. In the latter case, a medical device having a larger diameter may be introduced into the first lumen 22 and a medical device having a smaller diameter may be introduced into the second lumen 24. The first lumen 22 may have a lateral lumen opening 14 and the second lumen 24 may have a lumen opening at the distal end of the catheter 10. In order to guide a first medical device to the lateral lumen opening 14, the catheter 10 may include a slide inside the lumen with a hole in the center. The slide may be configured to guide the first medical device towards the lateral lumen opening 14 (side opening). Elements with smaller diameter (e.g. guide wires) can be advanced towards the distal opening of the catheter 10. In short, the catheter 10 shown in FIG. 7 may have two openings, one at the side and one distal, so that small diameters devices can be advanced towards the distal end, and bigger diameter devices are directed towards the side hole by the slide.

[0075] FIG. 8 shows a photograph of a catheter 10 having a similar shape as the catheter 10 according to the first embodiment. The catheter 10 has a distal tip like a prior art catheter but the flow sensor 12 with the opening 14 placed on the side (laterally) as described above.

[0076] With respect to FIGS. 9 to 11 some details of the flow sensor 12 are explained. FIG. 9 shows flow mapping in the region of the side branch 34. FIG. 10 shows flow mapping on anatomical mockup. It was demonstrated experimentally that the flow sensor 12 could identify the center 42 of a valve 40. FIG. 11 shows flow velocity measured with a flow sensor 12. Flow velocity is higher when close to the anatomical structure. When the sensor 12 is far from the anatomical structure the flow velocity measured is lower (see section 54 in FIG. 11) and when the sensor 12 moves towards the anatomical location the flow velocity signal gets higher (see section 56 in FIG. 11). That is, blood's flow speed changes its pattern when approaching certain anatomical regions, such as side branches 34 or stenosis (e.g. valves 40). The catheter 10 equipped with flow (velocity) sensor(s) 12 can perform measurements as represented in FIGS. 9 and 10 in form of flow map, and in FIG. 11 in form of velocity vs. time in order to enable a processing unit to derive the location of the anatomical region.

[0077] Certain anatomical structures can be identified by looking at the changes of the flow velocity, magnitude, direction and/or sense. This then facilitates the cannulation of catheters or delivery of certain medical devices. This further eliminates the need of using catheters with sharp edges.

[0078] By means of a catheter 10 equipped with one or more flow (velocity) sensor(s) 12 as described herein, the flow velocity or other quantities can be sensed/measured in different directions. The flow (velocity) sensor(s) 12 is/are able to sense changes in flow velocity/speed and flow direction, thereby being able to sense when the flow changes its profile that it normally has when flowing into a pipe/vessel. Strictions, stenosis and side branches 34 can then be identified.

[0079] Many advantages of the present disclosure will be fully understood from the foregoing description, and it will be apparent that various changes may be made in the form, construction and arrangement of the units and devices without departing from the scope of the present disclosure and/or without sacrificing all of its advantages. Since the present disclosure can be varied in many ways, it will be recognized that the present disclosure should be limited only by the scope of the following claims.