DEVICE FOR DELIVERING ENERGY AND/OR MEASURING ELECTRICAL ACTIVITY

Abstract

A device for delivering energy and/or measuring electrical activity in a tubular part of a body has a catheter and/or an inflatable balloon and at least one electrode. A distal end of the catheter with the at least one electrode, or the at least one electrode, is disposed on the outside of an envelope of the balloon. So as to achieve good contact between the at least one electrode and the wall of the vessel to be treated and continuous blood flow, the elasticity of the envelope of the balloon is less in at least one first region than in a second region that different from the first region. The distal end of the catheter with the at least one electrode is disposed in the at least one first region, or the at least one electrode is disposed in the at least one second region of the balloon.

Claims

1-11. (canceled)

12. A device for delivering energy and/or measuring electrical activity in a tubular part of a body, the device comprising: a catheter, an inflatable balloon and at least one electrode; a distal end of said catheter with said at least one electrode being disposed on an outside of an envelope of said balloon; at least one first region of the envelope of said balloon having an elasticity being less than an elasticity of at least one second region that is different from said first region; and said distal end of said catheter with said at least one electrode being disposed in said at least one first region.

13. The device according to claim 12, wherein the envelope of said balloon comprises fibers in said at least one first region which limit the elasticity of the envelope of said balloon in said at least first region.

14. The device according to claim 13, wherein said fibers of said first region comprise one or more materials selected from the group consisting of PEEK, Kevlar, polyimide, polyamide and metals.

15. The device according to claim 12, wherein the envelope of said balloon has a greater wall thickness in said at least one first region than in said at least one second region.

16. The device according to claim 12, wherein said at least one first region has a rhombus shape.

17. The device according to claim 12, wherein said at least one first region extends in a direction of a longitudinal axis of said balloon.

18. The device according to claim 12, wherein said at least one first region extends helically in a spiral shape about a longitudinal axis of said balloon.

19. The device according to claim 12, wherein said distal end of said catheter is fixed in points on the envelope of said balloon.

20. The device according to claim 12, wherein said at least one electrode is a conductive ring or a conductive half shell.

21. The device according to claim 12, wherein said at least one electrode is disposed in or on the envelope of said balloon in said at least one second region.

22. A device for delivering energy and/or measuring electrical activity in a tubular part of a body, the device comprising: an inflatable balloon and at least one electrode; said at least one electrode being disposed on an outside of an envelope of said balloon; at least one first region of the envelope of said balloon having an elasticity being less than an elasticity of at least one second region that is different from said first region; and said at least one electrode being disposed in said at least one second region.

23. The device according to claim 22, wherein the envelope of said balloon comprises fibers in said at least one first region which limit the elasticity of the envelope of said balloon in said at least first region.

24. The device according to claim 23, wherein said fibers of said first region comprise one or more materials selected from the group consisting of PEEK, Kevlar, polyimide, polyamide and metals.

25. The device according to claim 22, wherein the envelope of said balloon has a greater wall thickness in said at least one first region than in said at least one second region.

26. The device according to claim 22, wherein said at least one first region has a rhombus shape.

27. The device according to claim 22, wherein said at least one first region extends in a direction of a longitudinal axis of said balloon.

28. The device according to claim 22, wherein said at least one first region extends helically in a spiral shape about a longitudinal axis of said balloon.

29. The device according to claim 22, wherein a distal end of said catheter is fixed in points on the envelope of said balloon.

Description

[0024] In the schematic drawings:

[0025] FIG. 1 shows a first exemplary embodiment of a device according to the invention in a first state of the balloon where it is little inflated, in a view from the side;

[0026] FIG. 2 shows the exemplary embodiment according to FIG. 1 in a second state of the balloon where it is more strongly inflated, in a view from the side;

[0027] FIG. 3 shows a second exemplary embodiment of a device according to the invention in a more strongly inflated state and in a view from the side;

[0028] FIG. 4 shows the exemplary embodiment and the state according to FIG. 3 in a cross-section;

[0029] FIG. 5 shows a third exemplary embodiment of a device according to the invention in a more strongly inflated state and in a view from the side;

[0030] FIG. 6 shows the exemplary embodiment according to FIGS. 1 and 2 in the first, little inflated state, in a perspective view from the side;

[0031] FIG. 7 shows the exemplary embodiment according to FIGS. 1 and 2 in the second, more strongly inflated state, in a perspective view from the side;

[0032] FIG. 8 shows the exemplary embodiment and the state according to FIGS. 3 and 4 in a perspective view from the side;

[0033] FIG. 9 shows a fourth exemplary embodiment of a device according to the invention in a second, more strongly inflated state in a cross-section;

[0034] FIG. 10 shows the exemplary embodiment according to FIG. 9 in the state according to FIG. 9 in a section along the line A-A (see FIG. 9);

[0035] FIG. 11 shows a fifth exemplary embodiment in a second, more strongly inflated state in a view from the side; and

[0036] FIG. 12 shows the exemplary embodiment according to FIG. 11 in the state shown in FIG. 11, in a perspective view from the side.

[0037] The first exemplary embodiment of a device according to the invention shown in FIGS. 1, 2 and 6 and 7 comprises a catheter shaft, having a distal end denoted by reference numeral 10 in FIG. 1. The device furthermore comprises a balloon 12, which is shown partially inflated in FIGS. 1 and 6. The balloon 12 can be fastened to the preferably dual lumen shaft, which forms the distal end 10, or a shaft separate therefrom. The balloon 12 is furthermore connected to a gas source or a liquid source (NaCl solution) for inflation.

[0038] The balloon can be detachably fastened to the respective shaft. In this way, the device according to the invention can be adapted to the diameter of the respective vessel to be treated by replacing the balloon.

[0039] Moreover, electrodes 15 are disposed at the distal end 10 of the catheter shaft, which are preferably designed as annular electrodes.

[0040] FIGS. 2 and 7 shows a more strongly inflated stated compared to FIG. 1. In the rhombus-shaped first regions 20, in which fibers are embedded in the balloon envelope having lower elasticity than the balloon envelope in the remaining, second regions 22, rhombus-shaped constrictions are formed, which are recessed, while the balloon envelope protrudes further in the second regions 22 in a protuberance- or pillow-like manner. The distal end 10 of the catheter shaft comprising the electrodes 15 is disposed in the first region 20.

[0041] The differing extensibilities in the first regions 20 and in the second regions 22 can, alternatively, also be achieved by using differing materials in these regions. For example, the balloon envelope can be made of PI in the first regions 20, and of PU in the second regions 22.

[0042] In the inflated state, the differing extensibilities of the regions 20, 22 create a difference in height h (see FIG. 2) between the second regions 22 and the first regions 20, which is at least 0.5 mm, and preferably ranges between 1 mm and 2.5 mm. The difference in height is measured in the radial direction based on the balloon envelope.

[0043] In the second exemplary embodiment illustrated in FIGS. 3, 4 and 8, fibers 23 having the lower elasticity, and thus the first regions 20, extend parallel to the longitudinal axis 30 of the balloon 12. Since the elasticity of the balloon envelope is less in the first regions 20 than in the second regions 22, a cross-sectional shape of the balloon that resembles a butterfly is created (see FIG. 4). The distal end 10 of the catheter shaft comprising the electrodes 15 is disposed in the grooves or constrictions, which form the first regions 20 in the inflated state.

[0044] In the third exemplary embodiment shown in FIG. 5, the fibers 23, which are embedded into the balloon envelope in the first region 20 and have lesser elasticity, extend around the longitudinal axis 30 of the balloon 12 in a helical manner. The distal end 10 of the catheter comprising the electrodes 15 extends parallel to these fibers and, in the inflated state, is disposed in the corresponding grooves of the first region 20.

[0045] By way of the above-described exemplary embodiments of a device according to the invention, it is possible to achieve secure positioning of the electrodes 15 of the catheter on the inside wall of the treated vessel with good wall contact. Additionally, the first regions 20 receding in the inflated state create clearances, so that the blood can continue to flow in the vessel and thereby cool the treated site on the vessel.

[0046] In the exemplary embodiments of a device according to the invention shown in FIGS. 9 to 12, the electrodes 115 are disposed on the outside of the envelope of the balloon 112. The electrical connection of the electrically active electrodes 115 to a voltage source or further electronic components for measuring potentials or for ablation is not shown.

[0047] The exemplary embodiment shown in FIGS. 9 and 10 resembles that of FIGS. 3, 4 and 8, wherein the electrodes are disposed on the outside of the envelope of the balloon 112 in the protruding second regions 122. The elasticity of the balloon 112 in the receding first regions 120 is reduced by the non-extensible fiber 123 in the direction of the longitudinal axis 130 of the balloon 112. In the second regions 122, the balloon 112 additionally comprises sections 135 having a reduced wall thickness (see FIG. 10). In this way, an electrode 115 disposed in this section 135 protrudes more strongly upon inflation and is thus given even better contact with the vascular wall.

[0048] In the balloon 112, furthermore a tube 137 for feeding the inflation medium is disposed. Moreover, a clamping ring 140 is provided at the proximal end of the balloon 112, which is used to fix and support the balloon 112, and in particular the non-extensible fibers 123 integrated into the envelope of the balloon 112, on the tube 137. The clamping ring 140 is disposed on the outside of the balloon 112. Such a design comprising a tube for feeding the inflation medium and a clamping ring is also conceivable for the exemplary embodiment shown in FIGS. 3, 4 and 8.

[0049] In the exemplary embodiment according to FIGS. 9 and 10, furthermore a catheter, which is electrically inactive or likewise electrically active, can be fixed and guided past the treatment site and be used there to measure electrical potentials, pressures or temperatures, for example, or likewise for ablation, and for guiding guide wires, for example, and for applying liquids or other media.

[0050] Finally, FIGS. 11 and 12 show a further exemplary embodiment in which the balloon is designed analogously to the balloon of the exemplary embodiment according to FIG. 5 in terms of the elasticity thereof. The balloon 112 comprises fibers 123 integrated into the envelope, which have only little elasticity and extend about the longitudinal axis 130 of the balloon 112 in the form of a helix. The electrodes 115, which make good contact with the treated vessel due to the high extension in the second regions 122, are disposed on the outside of the balloon 112 in the second regions 122. Due to the irregular shape of the balloon 112, clearances are created in the receding first regions 120 in which the fibers 123 extend, which allow the blood to continue to flow in the vessel and thereby cool the treated site on the vessel.

LIST OF REFERENCE NUMERALS

[0051] 10 distal end of the catheter shaft [0052] 12 balloon [0053] 15 electrode [0054] 20 first region [0055] 22 second region [0056] 23 fiber [0057] 30 longitudinal axis of the balloon 12 [0058] 112 balloon [0059] 115 electrode [0060] 120 first region [0061] 122 second region [0062] 123 fiber [0063] 130 longitudinal axis of the balloon 112 [0064] 135 section [0065] 137 pipe [0066] 140 clamping ring