BALLOON CATHETER FOR ENDOVASCULAR TEMPERATURE CONTROL
20180303663 · 2018-10-25
Inventors
Cpc classification
A61F7/0085
HUMAN NECESSITIES
A61F2007/126
HUMAN NECESSITIES
International classification
Abstract
A balloon catheter for the endovascular temperature control of blood, with a catheter tube and at least one heat exchanger balloon which is convertible from an expanded operational state into a compressed insertion state. A temperature-control fluid can flow through the heat exchanger balloon, wherein the catheter tube includes at least one occlusion balloon which is arranged in series with the heat exchanger balloon.
Claims
1. A balloon catheter for the endovascular temperature control of blood, having a catheter tube and at least one heat exchanger balloon which is convertible from an expanded operational state into a compressed insertion state, wherein a temperature-control fluid can flow through the heat exchanger balloon, characterized in that the catheter tube comprises at least one occlusion balloon which is arranged in series with the heat exchanger balloon.
2. The catheter as claimed in claim 1, characterized in that the occlusion balloon is elastically dilatable to at least 150%, in particular at least 200%, in particular at least 300%, in particular at least 400%, in particular at least 500% of its diameter in the non-operational state.
3. The catheter as claimed in claim 1, characterized in that in the non-operational state, the occlusion balloon lies tubularly against the catheter tube.
4. The catheter as claimed in claim 1, characterized in that the heat exchanger balloon is elastically dilatable to at most 150%, in particular at most 130%, in particular at most 120%, in particular at most 110%, in particular at most 105% of its nominal diameter.
5. The catheter as claimed in claim 1, characterized in that the heat exchanger balloon is in fluid communication with a supply lumen and a return lumen and forms a closed temperature-control circuit.
6. The catheter as claimed in claim 1, characterized in that a plurality of heat exchanger balloons are arranged in series on the catheter tube.
7. The catheter as claimed in claim 1, characterized in that the occlusion balloon is arranged distally to at least one heat exchanger balloon.
8. The catheter as claimed in claim 1, characterized in that the occlusion balloon is arranged proximally to at least one heat exchanger balloon.
9. The catheter as claimed in claim 1, characterized in that the occlusion balloon is in fluid communication with a lumen with a diameter of at most 1 mm, in particular at most 0.8 mm, in particular at most 0.6 mm, in particular at most 0.4 mm, in particular at most 0.3 mm, in particular at most 0.25 mm.
10. The catheter as claimed in claim 1, characterized in that the catheter tube comprises at least two lumens for the heat exchanger balloon, at least one lumen for the occlusion balloon and at least one further lumen for inserting a functional element, in particular a microcatheter, an intermediate catheter, a recanalization device or a thrombectomy device.
11. A system having a catheter as claimed in claim 1, an extracorporal cooling unit and a tubing set for connecting the catheter to the extracorporal cooling unit, wherein the catheter tube comprises a supply lumen and a return lumen which are connected to the tubing set on the one hand and to the heat exchanger balloon on the other hand such that a closed coolant circuit is formable or formed.
12. The system as claimed in claim 11, characterized in that the cooling unit comprises at least one temperature-control element for cooling a coolant flowing through the tubing set and at least one fluid-delivery device for generating a flow of coolant inside the tubing set.
13. The system as claimed in claim 12, characterized in that the fluid-delivery device is a peristaltic pump.
14. The system as claimed in claim 12, characterized in that the temperature-control element is formed by a Peltier element.
15. The system as claimed in claim 12, characterized in that the tubing set is provided with a flow-through pouch which can be inserted between two temperature-control elements such that the coolant flowing through the pouch is cooled by the temperature-control elements.
Description
[0045] The invention will now be explained in more detail with the aid of exemplary embodiments, with reference to the accompanying diagrammatic drawings in which:
[0046]
[0047]
[0048]
[0049]
[0050] The exemplary embodiment depicted in
[0051] The carotid artery comprises a main vessel, the arteria carotis communis, ACC, which divides into the arteria carotis interna, ACI and the external carotid artery or arteria carotis externa, ACE. In the exemplary embodiment depicted, a thrombus 20 has formed in the medial carotid artery, distal to the arteria carotis interna, ACI; the thrombus hinders the flow of blood into portions of the brain tissue. In order to remove the thrombus 20, the balloon catheter 10 in accordance with the invention can be used.
[0052] The balloon catheter 10 comprises a catheter tube 11 on which an occlusion balloon 13 is arranged. The occlusion balloon 13 is arranged at a distal section of the balloon catheter 10.
[0053] A plurality of heat exchanger balloons 12 are arranged on the catheter tube 11 proximally to the occlusion balloon 13. Four heat exchanger balloons 12 can be seen in the drawing. A different number of heat exchanger balloons 12 may also be envisaged.
[0054] In the depicted treatment status of the balloon catheter 10, the occlusion balloon 13 has been expanded and elastically dilated so that the occlusion balloon 13 seals against the vessel walls of the arteria carotis interna, ACI. In this regard, the occlusion balloon 13 is formed as a compliant balloon which is elastically dilatable beyond its nominal diameter. This guarantees a good seal with the blood vessel.
[0055] In contrast, the heat exchanger balloons 12 are formed as non-compliant balloons and have a nominal diameter which is preferably smaller than the nominal diameter of the occlusion balloon 13, in particular smaller than the diameter of the occlusion balloon 13 in use, i.e. when sealing a blood vessel. The heat exchanger balloons 12 essentially have no or only a negligible elastic dilatability. In particular, the dimensions of the heat exchanger balloons 12 are preferably such that they can be expanded to a diameter which is smaller than the vessel diameter. This ensures that blood can still flow by the heat exchanger balloons 12 and exchange heat with the blood which is flowing by.
[0056] In the exemplary embodiment shown, the balloon catheter 10 comprises a through-lumen 18 which accommodates a guide catheter 15, for example. The guide catheter 15 here is guided inside the through-lumen 18 in a longitudinally displaceable manner and can leave the through-lumen at a distal opening 14. In addition to guiding the guide catheter 15, the through-lumen may also be used for aspiration. In this manner, blood and, if appropriate, detached thrombus components can be sucked away.
[0057] The guide catheter 15 can be pushed up to close to the thrombus 20. In particular, the guide catheter 15 is highly flexible so that it can be guided correctly through narrow and tortuous blood vessels to the treatment site. The guide catheter 15 comprises a through channel 19 through which a microcatheter 17 can be pushed. In preferred embodiments of the invention, the guide catheter 15 can be connected to suction test equipment so that aspiration can be carried out via the guide catheter 15. In this manner, components of the thrombus close to the treatment site can be sucked away. In addition, the through-lumen 18 of the catheter tube 11 may be connected to or connectable to a suction device or aspiration device.
[0058] Preferably, a longitudinally displaceable transport wire is arranged inside the microcatheter 17 which is firmly attached to or releasably attached to a thrombectomy device 16 at a distal end. The thrombectomy device 16 can be pushed onto the thrombus 20 by means of the transport wire. As an example, the thrombectomy device 16 might be a self-expandable lattice structure which connects itself to the thrombus 20. In this manner, the thrombus 20 can be removed with the aid of the thrombectomy device 16 and be withdrawn into the catheter tube 11.
[0059] Further lumens with different functions may extend in the catheter tube 11 in addition to the through-lumen 18. Thus, at least one lumen is provided which is in fluid communication with the occlusion balloon 13. The occlusion balloon 13 can be expanded and compressed again via the lumen which is connected to the occlusion balloon 13. To this end, a fluid, for example saline solution, preferably with added contrast agents, is fed into the occlusion balloon 13 or withdrawn therefrom.
[0060] The heat exchanger balloons 12 are preferably connected to two lumens, wherein the heat exchanger balloons 12 have a supply lumen 21 on one side and a return lumen 22 on the other side. The fluid connections between the individual heat exchanger balloons 12 and the supply lumen 21 or the return lumen 22 are preferably arranged at the respective longitudinal ends of the heat exchanger balloon 12. In particular, the supply lumen 21 may discharge at a distal end of the heat exchanger balloon 12 and the return lumen 22 may be in fluid communication with a proximal end of the heat exchanger balloon 12. This ensures that temperature-control fluid which reaches the heat exchanger balloon 12 via the supply lumen 21 flows through the entire heat exchanger balloon 12 before it is withdrawn from the heat exchanger balloon 12 via the return lumen 22. It is also possible to envisage each heat exchanger balloon 12 having a respective supply lumen 21 and a return lumen 22. However, preferably, the heat exchanger balloons 12 are connected together with a single supply lumen 21 and a single return lumen 22. In this regard, the heat exchanger balloons 12 are preferably connected in series or belong to a common temperature-control circuit. In particular, it is possible for a single supply lumen 21 to be connected to the distal or proximal heat exchanger balloon 12 and for the heat exchanger balloons 12 to be connected together in series via the return lumen 22.
[0061] The occlusion balloon 13 is preferably designed such that the diameter of the occlusion balloon 13 increases by 1 mm above its non-operational state at a fluid pressure of less than 0.5 bar. In particular, the occlusion balloon 13 may be designed such that its diameter enlarges by 3 mm beyond the non-operational state when a pressure of less than 1 bar prevails inside the occlusion balloon 13. In the non-operational state, the occlusion balloon 13 is preferably tubular in shape, wherein the internal diameter of the occlusion balloon 13 essentially corresponds to the external diameter of the catheter tube 11. Preferably, the diameter of the occlusion balloon 13 in the non-operational state is at least 0.4 mm, 0.6 mm, 0.8 mm, 1.0 mm, 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, 2.0 mm smaller than the diameter of the heat exchanger balloon 12 or of the plurality of heat exchanger balloons 12. This is the case for all of the exemplary embodiments of the invention.
[0062] In contrast, the heat exchanger balloons 12 are configured such that at a pressure of at least 1 bar which is applied by the temperature-control fluid to the heat exchanger balloon 12, it enlarges in diameter by less than 0.5 mm compared with the non-operational state diameter. In this regard, the non-operational state essentially corresponds to a state in which the heat exchanger balloon 12 lies almost completely against the catheter tube 11. The nominal diameter of the heat exchanger balloon 12 is reached when an elastic deformation occurs upon increasing the pressure inside the heat exchanger balloon 12 further. This elastic deformation is preferably limited such that the elastic dilation of the heat exchanger balloon 12 with respect to the nominal diameter is a maximum of 20%, in particular a maximum of 10%, in particular a maximum of 5%. Here again, this is the case for all of the exemplary embodiments of the invention. The values mentioned above are in particular valid for a pressure of 2 bar.
[0063] Regarding the use of the balloon catheter in accordance with the invention, several possibilities may be envisaged. On the one hand, the balloon catheter 10 may be used for the removal of thrombi 20.
[0064] On the other hand, it is also possible for the occlusion balloon 13 to be used for vessel dilation or for stenosis dilation. In this case, the heat exchanger balloon 12 or the occlusion balloon 13 may also undertake the function of blocking stenosis particles which are sometimes detached during dilation. For such an application, it may be advantageous to provide an additional aspiration lumen which discharges between the occlusion balloon 13 and the heat exchanger balloon 12. In this manner, blood and particles can efficiently be sucked up from the region between the occlusion balloon 13 and the heat exchanger balloon 12.
[0065]
[0066] The different cross-sectional diameters result from the internal construction of the catheter tube 11, which differ in the distal section 11b and in the proximal section 11a. A through-lumen 18 extends through the entire catheter tube 11. The through-lumen 18 may be used to supply medication, cold or warm fluids such as contrast agents, treatment catheters or instruments, in particular to suck up or aspirate or remove blood clot particles. Furthermore, a supply lumen 21 and a return lumen 22 as well as a lumen for the occlusion balloon, in particular an occlusion-fluid lumen 23, extend through the catheter tube 11. The supply lumen 21 and the return lumen 22 are in fluid communication with the heat exchanger balloons 12, so that a coolant circuit can be formed. In this regard, the supply lumen 21 and the return lumen 22 may be connected to an extracorporal cooling unit via a tubing set so that a coolant circuit is produced which provides for a continuous supply of coolant and withdrawal of coolant for the heat exchanger balloons 12.
[0067] The supply lumen 21 and the return lumen 22 preferably extend only in the proximal section 11a of the catheter tube 11. In addition, the occlusion-fluid lumen 23 and the through-lumen 18 extend through the proximal section 11a. In all of the exemplary embodiments of the invention, the through-lumen 18 also extends through the distal section 11b. The occlusion-fluid lumen 23 may also extend through the distal section 11b or merge directly into the occlusion balloon 13 at the distal end of the proximal section 11a. Such an exemplary embodiment is shown in
[0068] When the occlusion balloon 13 is arranged distally from the distal end of the proximal section 11a of the catheter tube 11, then the occlusion-fluid lumen 23 also flows inside the distal section. A configuration of this type is shown in
[0069] Similarly, in preferred exemplary embodiments, the supply lumen 21 and the return lumen 22 are arranged only inside the proximal section 11a of the catheter tube 11. Because of the smaller number of lumens, the distal section 11b may thus be thinner, i.e. it may have a smaller external diameter.
[0070]
[0071]
[0072] The cross-sectional drawings of
[0073] As an example, the inner tube 24 may consist of polyimide or polyamide or PTFE or a similar material. The inner tube 24 may be reinforced with a metal, for example in the form of a helically wound wire (coil). The metal preferably includes stainless steel or a nickel-titanium alloy, in particular Nitinol. The plastic matrix, i.e. the catheter tube 11 itself, is preferably formed from polyurethane or polyether block amide (PEBA) or polyamide (nylon) or polyethylene (PE) or Teflon. The heat exchanger balloons 12 may consist of polyamide or polyurethane or PEBA or PE. The catheter tube may be at least partially coated. In particular, a hydrophilic coating may be provided.
[0074] Furthermore, the through-lumen 18 or an inner tube 24 of the through-lumen 18 may be provided with a circumferential inner surface which is provided with a coating formed from PTFE or fluoroethylene propylene (FEP). The inner tube 24 itself may also consist of a friction-reducing material or may have an inner lining which faces the through-lumen and is friction-reducing. The friction-reducing material may include PTFE or FEP or consist of it. In addition, the inner tube 24 of the through-lumen 18 may be reinforced with metal.
[0075] The inner tube 24, in particular the inner tube 24 of the through-lumen 18, may be multi-layered. As an example, an inner layer facing the through-lumen 18 may be formed from a friction-reducing material, in particular PTFE or FEP, and an outer layer may be formed by polyurethane or Pebax. The outer layer may in general be formed from the same material as the plastic matrix of the catheter tube 11 or a material which differs therefrom.
[0076] The entire catheter tube 11, in particular also in the distal section 11b of the catheter tube 11, may have the cross-sectional construction of the through-lumen 18, in particular of the through-lumen 18 equipped with a multi-layered inner tube 24. In particular, the inner tube 24, for example with an inner layer formed from a friction-reducing material and an outer layer formed from another material as well as a metal reinforcement, may continue unchanged into the distal section 11b. The outer layer may be identical in the distal section 11b and in the proximal section 11a. However, it is also possible for the outer layer in the distal section 11b of the catheter tube 11 to consist of a material which is softer than the material of the outer layer in the proximal section 11a of the catheter tube 11. Similarly, the material of the plastic matrix of the catheter tube 11 in the distal section 11b may differ from the material of the plastic matrix of the catheter tube 11 in the proximal section 11a; in particular, the distal section 11b may be softer or more deformable than in the proximal section 11a.
[0077] Particularly preferably, the lumens, in particular the supply lumen 21, the return lumen 22 and/or the occlusion-fluid lumen 23 have an inner tube 24 or a circumferential inner surface of the respective lumen which consists of or is coated with polyimide.
[0078] For all exemplary embodiments with a catheter tube 11 which have a proximal section 11a and a distal section 11b, the external diameter of the catheter tube 11, at least in the proximal section 11a, may be in the range 3 mm to 4 mm, in particular in the range 3.2 mm to 3.8 mm, preferably in the range 3.4 mm to 3.6 mm.
[0079] The distal section 11b of the catheter tube 11 may exclusively comprise the through-lumen 18 and the occlusion-fluid lumen 23. The external diameter of the catheter tube 11 in the distal section 11b is preferably in the range 2 mm to 3.5 mm, in particular in the range 2.3 mm to 3.2 mm, in particular in the range 2.5 mm to 3 mm, preferably 2.8 mm.
[0080] The difference between the external diameter of the proximal section 11a and the external diameter of the distal section 11b is preferably at least 0.2 mm, in particular at least 0.4 mm, in particular at least 0.6 mm, in particular at least 0.8 mm, and/or at most 1.5 mm.
[0081] In a variation of the balloon catheter 10 in accordance with the invention, the length of the distal section 11b without the supply lumen 21 and return lumen 22 may be in the range 10 mm to 50 mm, in particular in the range 20 mm to 40 mm. These variations are suitable for a treatment in which, because of the short distance between the occlusion balloon 13 and the proximal section 11a, the risk of injury is to be reduced. In an alternative variation, which may be employed in order to seal off a vessel highly distally, i.e. at a a large distance from the proximal section 11a, the length of the distal section 11b may be in the range 20 mm to 150 mm, in particular in the range 30 mm to 120 mm, in particular in the range 40 mm to 100 mm, in particular in the range 50 mm to 80 mm. For both of these variations, the occlusion balloon 13 is preferably very close to or directly at the distal end of the distal section 11b, i.e. at the tip of the catheter tube 11. In particular, the distance of the occlusion balloon 13 or the distal end of the occlusion balloon 13 from the tip of the catheter tube 11 is at most 10 mm, in particular at most 8 mm, in particular at most 6 mm, in particular at most 4 mm. The distance between the occlusion balloon 13 and the tip of the catheter tube 11 may be at least 1 mm.
[0082] The occlusion balloon 13 preferably has a length in the range 3 mm to 20 mm, in particular in the range 5 mm to 15 mm, in particular in the range 8 mm to 12 mm. The wall thickness of the occlusion balloon 13 may be at most 100 m, in particular at most 80 m, in particular at most 60 m, in particular at most 40 m, in particular at most 20 m. Preferably, the wall thickness is at least 10 m. Suitable materials for the occlusion balloon 13 are Kraton and/or Chronoprene and/or Pellethane and/or latex and/or silicone.
[0083] The segment which contains the heat exchanger balloons 12, in particular the section of the catheter tube 11, which is defined proximally by the proximal end of the first heat exchanger balloon 12 and distally by the distal end of the last heat exchanger balloon 12, preferably has a length which is in the range 20 mm to 150 mm, in particular in the range 40 mm to 120 mm, in particular in the range 60 mm to 100 mm, preferably 80 mm. Each heat exchanger balloon 12 may have a respective length in the range 10 mm to 30 mm, in particular 20 mm. The wall thickness of the heat exchanger balloon 12 is preferably in the range 10 m to 40 m, in particular in the range 15 m to 30 m.
[0084] The occlusion balloon 13 may be funnel-shaped at its distal end or merge with the catheter tube 11 in the shape of a funnel. In this manner, introduction of the occlusion balloon 13 into a blood vessel, in particular into a section of a vessel with a thrombus 20, is thus facilitated. It is also possible for the occlusion balloon 13 to be in the shape of a funnel which widens in the distal direction, in order to thereby facilitate introduction of a thrombus 20 into the catheter 11 upon aspiration.
[0085] The occlusion balloon 13 may be in fluid communication with a plurality of occlusion-fluid lumens 23, or the occlusion-fluid lumen 23 may be divided into a plurality of part lumens which are each arranged in the space left between the supply lumen 21, the return lumen 22 and the through-lumen in order to exploit the available space inside the catheter tube 11 to the best extent possible. The balloon catheter 10 may be provided with a plurality of, in particular two occlusion balloons 13, so that at the same time an occlusion, i.e. closing off of a vessel, can be carried out at different locations.
[0086] Moreover, a radiographic marker may be provided at the proximal and distal ends of the occlusion balloon 13. This aids the user in correctly positioning the occlusion balloon 13 in the blood vessel. It is also possible to provide at least one radiographic marker at only one end of the occlusion balloon 13 and/or in the middle of the occlusion balloon 13. In addition to or as an alternative, a respective radiographic marker may be placed at the distal tip of the catheter tube 11 and/or at the proximal and/or distal end of the segment of the catheter tube 11 in which the heat exchanger balloons 12 are arranged. In total, then, three radiographic markers, two end radiographic markers at the proximal and distal ends of the occlusion balloon 13, as well as one in the middle of the occlusion balloon 13, may be provided.
[0087] The supply lumen 21 and the return lumen 22 may be closed at the distal end of the proximal section 11a of the catheter tube 11 by a melting process and/or a bonding process. In general, then, the supply lumen 21 and the return lumen 22 are closed at the distal end of the proximal section 11a of the catheter tube 11. The supply lumen 21 and the return lumen 22 may then be respectively connected to the heat exchanger balloons 12 via lateral, in particular radial openings. In analogous manner, the occlusion-fluid lumen 23 may be closed distally by bonding or melting and be connected to the occlusion balloon 12 by means of a lateral, in particular radial opening.
[0088] The supply lumen 21 and the return lumen 22 may respectively have an internal diameter in the range 0.5 mm to 1.5 mm, in particular in the range 0.8 mm to 1.2 mm, preferably 1 mm. In this manner, a sufficient volume flow of coolant is ensured. At the same time, the supply lumen 21 and the return lumen 22 take up only a little space in the catheter tube 11, so that sufficient space remains for a through-lumen 18 of suitable dimensions.
[0089] In general, the occlusion balloon 13 may be arranged at any location along the catheter tube 11. In particular, the occlusion balloon 13 may be arranged both in the proximal section 11a, and also in the distal section 11b of the catheter tube. In the proximal section 11a, the occlusion balloon 14 may be proximal or distal to the at least one heat exchanger balloon. When the occlusion balloon 13 is arranged in the proximal section 11a, the distal section 11b is free from balloons. In this case, the catheter tube 11 in the distal section 11b has only the through-lumen 18. The distal section 11b is then particularly flexible and inserting the balloon catheter 10 into narrow, tortuous blood vessels is facilitated.
[0090] At the proximal end of the balloon catheter 10, in particular of the catheter tube 11, separate connections may be provided for one or more of the lumens (through-lumen 18, supply lumen 21, return lumen 22, occlusion-fluid lumen 23).
[0091] The connections may be parts of a common Luer connector. It is also possible for each lumen to have its own Luer adapter or connector. In particular, each lumen may be assigned to a connection line which has a Luer adapter or connector at one proximal end.
[0092] The total length of the balloon catheter 10 or the catheter tube 11 is preferably in the range 40 cm to 150 cm. In particular, the total length may be in the range 70 cm to 120 cm, preferably in the range 80 to 100 cm, specifically cm. The values given just above are of particular advantage for a balloon catheter for neurovascular applications.
[0093] The distal end or the distal tip of the catheter tube 11, in particular of the distal section 11b of the catheter tube 11, is preferably rounded. This reduces the risk of injury when passing the balloon catheter 10 through blood vessels.
LIST OF REFERENCE NUMERALS
[0094] 10 balloon catheter [0095] 11 catheter tube [0096] 11a proximal section [0097] 11b distal section [0098] 12 heat exchanger balloon [0099] 13 occlusion balloon [0100] 14 distal opening [0101] 15 guide catheter [0102] 16 thrombectomy device [0103] 17 guide catheter [0104] 18 through-lumen [0105] 19 through channel [0106] 20 thrombus [0107] 21 supply lumen [0108] 22 return lumen [0109] 23 occlusion-fluid lumen [0110] 24 inner tube [0111] ACI arteria carotis interna [0112] ACE arteria carotis externa [0113] ACC arteria carotis communis