CATHETER TUBE FOR A STEERABLE CATHETER, AND METHOD FOR IMPLANTING AN IMPLANTABLE MEDICAL DEVICE BY MEANS OF A STEERABLE CATHETER

Abstract

A catheter tube comprises a tube wall, which surrounds a tube lumen, wherein the tube wall comprises the following: a mesh; and a guide lumen around which the mesh is braided and in which a pull element extends from a proximal portion of the catheter tube to a distal portion of the catheter tube. The pull element is connected in a tension-resistant manner to the tube wall in the distal portion. The guide lumen guides the pull element at least partially around the tube lumen.

Claims

1. A catheter tube for a steerable catheter, comprising a tube wall surrounding a tube lumen, the tube wall comprising the following: a mesh; and a guide lumen around which the mesh is braided and in which a pull element extends from a proximal portion of the catheter tube to a distal portion of the catheter tube, the pull element being connected in a tension-resistant manner to the tube wall in the distal portion, and the guide lumen guiding the pull element at least partially around the tube lumen.

2. The catheter tube according to claim 1, wherein the guide lumen describes at least a section of a helical path around the tube lumen.

3. The catheter tube according to claim 1, wherein the guide lumen extends across a circumferential angel of at least 30° in the tube wall.

4. The catheter tube according to claim 1, wherein the guide lumen is delimited by a guide lumen tube.

5. The catheter tube according to claim 4, wherein the guide lumen tube comprises Teflon.

6. The catheter tube according to claim 1, wherein the distal portion can be deformed three-dimensionally by an actuation of the pull element.

7. The catheter tube according to claim 6, wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that the distal portion is bent with respect to a main extension axis of the proximal portion.

8. The catheter tube according to claim 6, wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that the distal portion describes at least a section of a spiral-shaped or helical path.

9. The catheter tube according to claim 6, wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that local extension axes of the distal portion, as seen in a projection along a main extension axis of the catheter tube, pass over an angle in the range of at least 30°.

10. The catheter tube according to claim 6, wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that local extension axes of the distal portion, in a projection along a main extension axis of the catheter tube, describe at least approximately a section of a circular arc having a radius in the range of 2 mm to 100 mm.

11. The catheter tube according to claim 1, wherein the catheter tube comprises a plurality of tube segments having differing rigidities.

12. A method for implanting an implantable medical device by means of a steerable catheter, wherein the steerable catheter comprises a catheter tube according to claim 1, and that the method comprises the following steps: inserting the catheter into the patient's body, and advancing the distal portion of the catheter tube into the vicinity of a desired implantation site; deforming the distal portion, by an actuation of the pull element, in such a way that a distal end of the catheter tube rests against the tissue; fixing the implantable medical device at the desired implantation site by means of the catheter; and removing the catheter from the patient's body.

13. The method according to claim 12, wherein the implantable medical device is a cardiac pacemaker electrode lead, which is implanted in a location in the patient's heart suitable for HIS bundle pacing by means of the method.

14. The method according to claim 12, wherein the implantable medical device is a sensor, which is implanted into a pulmonary artery of the patient by means of the method.

15. The method according to claim 12, wherein the implantable medical device is an implantable leadless pacemaker, which is implanted into the heart of the patient by means of the method.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0067] Further advantages and embodiments of the present invention shall be described hereafter with reference to the figures. In the drawings:

[0068] FIG. 1 shows an exemplary embodiment of a catheter tube in a non-formed state;

[0069] FIG. 2 shows a radial cross-section through the catheter tube of FIG. 1;

[0070] FIG. 3 shows a longitudinal section through the catheter tube of FIG. 1;

[0071] FIG. 4 shows the catheter tube of FIG. 1 in a formed state;

[0072] FIG. 5 shows a formed distal portion of the catheter tube of FIG. 1 in a projection along a main extension axis of the catheter tube; and

[0073] FIG. 6 shows a schematic block diagram including steps of a method for implanting an implantable medical device.

DETAILED DESCRIPTION

[0074] FIG. 1 schematically and by way of example shows a catheter tube 1 comprising a proximal portion 1-1 and a distal portion 1-2. The proximal portion 1-1 can, for example, transition into a rigid shaft (not shown). A grip can be arranged at the shaft, which a physician can use, for example, to handle the catheter. The distal portion 1-2, and in particular a distal end 1-20 of the catheter tube 1, is intended to be advanced within a patient's body to a location at which an implantation, a treatment or diagnostics is or are to be carried out.

[0075] The catheter tube 1 has a tube lumen L that is delimited by a tube wall 10. The tube wall 10 can, for example, be partially made of a flexible plastic material, such as silicone, which can also ensure sufficient tightness of the lumen. For example, a section of an outer layer 105 of the catheter 1 is shown in the proximal region in FIG. 1, which can be made of such a plastic material, for example.

[0076] Moreover, the tube wall 10 is reinforced by a mesh 101, such as a textile mesh, made of cotton or silk, for example, a wire mesh, preferably made of stainless steel or other metals, or a plastic mesh, made of polyamide (PA), polyurethane (PU), polyether block amide (PEBA, for example PEBAX), or polyether ether ketone (PEEK), for example. This is illustrated in FIG. 1 in particular in the distal portion 1-2 of the catheter tube 1. It shall be understood that the outer layer 105 can also extend in this portion, however it is not shown there for illustrative reasons so as to clearly show the mesh 101.

[0077] The tube wall 10 furthermore comprises a guide lumen 102 around which a mesh 101 is braided. A pull element 103, for example in the form of a pull wire, extends in the guide lumen 102, from the proximal portion 1-1 of the catheter tube 1 to the distal portion 1-2 of the catheter tube 1. The pull element 103 is connected in a tension-resistant manner to the tube wall 10 (and, if necessary, also to the mesh 101) in the distal portion 1-2.

[0078] The guide lumen 102 embedded into the mesh 101 guides the pull element 103 once completely around the tube lumen L in the distal portion 1-2 along a helical line. In other embodiments, it may be provided that the guide lumen 102 only describes a partial section of a helical path around the tube lumen L. In still other variant embodiments, the guide lumen 102 can even be helically guided multiple times around the tube lumen L.

[0079] For example, it may be provided that the guide lumen 102 extends across a circumferential angle of at least 30° in the tube wall 10. This means that, when looking at the catheter tube in a state in which it extends linearly along a main extension axis Z (as shown in FIG. 1), the guide lumen 102, as seen in a projection along the main extension axis Z, extends across a region along the circumference of the tube wall 10 which (based on a center of the catheter tube 1) spans an angle of at least 30°. The circumferential angle can also be larger and is, for example, 360° in the embodiment shown in FIG. 1. This is also the case, for example, in embodiments (which are not shown here) in which the guide lumen 102 is completely guided multiple times around the tube lumen L, as if on a spiral or helical path.

[0080] FIG. 2 schematically and by way of example shows a radial cross-section (along line A-A of FIG. 1) through the catheter tube 1. The cross-section A-A extends through a plane XY perpendicularly to the main extension direction Z of the catheter tube 1 of FIG. 1.

[0081] It is apparent based on the cross-section A-A that the tube lumen L is delimited by an inner layer 104 of the tube wall 10. Furthermore, the aforementioned outer layer 105 is apparent. The inner layer 104 and the outer layer 105 can, for example, be composed of one plastic material, or also of plastic materials that are different from one another, such as silicone (SI), polyurethane (PU), polyether block amide (PEBA, for example PEBAX), polyethylene (PE), or also polyamide (PA).

[0082] FIG. 3 schematically and by way of example shows a longitudinal section (along line A-A of FIG. 1) through the catheter tube 1. The cross-section B-B extends through a plane XZ parallel to the main extension direction Z of the catheter tube 1 of FIG. 1.

[0083] The mesh 101, in which, in turn, the guide lumen 102 is embedded, together with the pull element 103, as is shown in FIGS. 2 and 3, is arranged between the inner layer 104 and the outer layer 105. In the process, the guide lumen 102 is delimited by a guide lumen tube 1021, for example in the form of a Teflon tube, in the shown exemplary embodiment. In this way, it can be ensured that the pull element 103 is able to slide unimpaired within the tube wall 10 for transmitting a pulling force and is not, for example, blocked by the mesh 101 in the process.

[0084] FIG. 4 represents the catheter tube of FIG. 1 in a formed state. For example, the catheter tube 1 can be transferred from the non-deformed state shown in FIG. 1 into the formed state shown in FIG. 4 by a pulling actuation of the pull element 103. As is shown by way of example and schematically in FIG. 4, the catheter tube 1 can be deformed in the process in such a way the distal portion 1-2 is bent with respect to the main extension axis Z of the proximal portion 1-1. In FIG. 4, the distal end 1-20 extends, for example with a considerable directional component, in the direction X that is perpendicular to the main extension plane Z.

[0085] At the same time, a partial deflection in the direction Y, which is perpendicular to directions X and Z, can take place. In this way, the distal end 1-20 of the catheter tube 1 can, for example, not only be “bent” in the manner of a straw (corresponding to a two-dimensional deformation, for example within a plane XZ through the main extension axis Z), but it is also possible, by an actuation of the pull element 103, to effectuate a three-dimensional deformation of the distal portion 1-2 of the catheter tube 1. As is illustrated in FIG. 4, the deformed distal portion 1-2 of the catheter tube 1 can, for example, follow at least a section of a helical path around the main extension plane Z.

[0086] For further illustration, FIG. 5 shows a shaped distal portion 1-2 of the catheter tube 1 in a projection along a main extension axis Z (that is, a projection into plane XY). It is apparent from this that the catheter tube 1 can be deformed by an actuation of the pull element 103 in such a way that, as a result, respective local extension axes C, C′ of the distal portion 1-2, as seen in a projection along the main extension axis Z of the catheter tube 1 (in particular along a main extension axis Z of the proximal portion 1-1), pass over an angle α of at least 30°. However, as is shown by way of example in FIG. 5, the passed over angle α can also be larger than 90°. The angle α is preferably in the range of 30° to 270°.

[0087] Furthermore, as is likewise illustrated in FIG. 5, the formed distal portion 1-2, in the projection along the main extension axis Z, can at least approximately describe a section of a circular arc, wherein an associated radius R is preferably in the range of 2 mm to 100 mm.

[0088] FIG. 6 shows a schematic block diagram including method steps of a method for implanting an implantable medical device by means of a steerable catheter comprising a catheter tube 1 according to the above-described type.

[0089] The method comprises the following steps:

[0090] In a first step S1, the catheter is inserted into the patient's body, and the distal portion 1-2 of the catheter tube 1 is advanced into the vicinity of a desired implantation site.

[0091] For example, the catheter tube 1 can be in the first, non-formed state shown in FIG. 1, which can also be referred to as a relaxed or neutral state, during insertion and advancement (step S). For example, it can be provided that no, or at the most a low, pulling force is exerted by means of the pull element 103 in the non-formed state.

[0092] In a second step S2, the distal portion 1-2 is deformed, by an actuation of the pull element 103, in such a way that the distal end 1-20 of the catheter tube 1 rests against the tissue. In the process, the distal end 1-20 assumes a second, formed state in which it can be more rigid, for example, than in the first state. In the second state, the distal end 1-20 of the catheter tube 1 can, for example, be braced with a relatively high force against the tissue.

[0093] A third step S3 provides a fixation of the implantable medical device at the desired implantation site by means of the catheter. In the process, the catheter tube 1 can, for example, remain in the second, formed state.

[0094] Finally, the catheter is removed from the patient's body in a fourth step S4. For removal, the catheter tube 1 can (by renewed actuation of the pull element 103, for example such that a pulling force is released) be brought into the first, non-formed state again. In this way, the retraction of the catheter tube 1 through the vessels of the patient can be facilitated, as a result of a greater flexibility of the distal portion 1-2.

[0095] The implantable medical device can, for example, be a cardiac pacemaker electrode lead, which is implanted in a location in the patient's heart suitable for HIS bundle pacing, using the described method. As an alternative, the implantable medical device can be a sensor, such as a pressure sensor, which is implanted into a pulmonary artery by means of the described method. Still another embodiment provides that the implantable medical device is an ILP, which is implanted into the heart.

[0096] Further possible details and optional additional method steps in connection with such methods that use a catheter tube 1 according to the present invention were already described above.

[0097] It shall be mentioned that a catheter tube 1 according to the present invention can also be employed in applications other than those described in greater detail above, such as for steering devices for cryo applications, as well as for targeted drug delivery, or for steering ablation or diagnostic catheter.

[0098] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.

LIST OF REFERENCE NUMERALS

[0099] 1 catheter tube [0100] 1-1 proximal portion [0101] 1-2 distal portion [0102] 1-20 distal end [0103] 10 tube wall [0104] 101 mesh [0105] 102 guide lumen [0106] 1021 guide lumen tube [0107] 103 pull element [0108] 104 inner layer [0109] 105 outer layer [0110] C, C′ local extension axes [0111] L tube lumen [0112] S1-S4 method steps