Thrombectomy catheter device

Abstract

The invention relates to a thrombectomy catheter device which comprises: a catheter tube unit (1), which has an aspiration lumen (2) and a pressurized-fluid lumen (3); and a pressurized-fluid nozzle arrangement (4) in a distal end region (1a) of the catheter tube unit, wherein the pressurized-fluid nozzle arrangement is designed to emit a pressurized fluid conducted in the pressurized-fluid lumen into a distal aspiration effective region (2a) of the aspiration lumen as a pressurized-fluid jet which breaks down tissue. The pressurized-fluid nozzle arrangement comprises an annular nozzle (5) having an annular cavity (6), into which the pressurized-fluid lumen leads and which surrounds at least part of the distal aspiration effective region of the aspiration lumen, and having a plurality of nozzle openings (7), which lead out of the annular cavity at a radial inner face (5a) of the annular nozzle. According to the invention, the annular nozzle is designed with its annular cavity in a closed annular shape which extends continuously over 360° in the circumferential direction, and / or the annular nozzle is constructed of an inner annular part and an outer annular part which surrounds the inner annular part to form the annular cavity lying therebetween, and / or the annular nozzle has at least one pressure relief opening which extends from an outer face (5b) of the annular nozzle through the annular nozzle to the radial inner face of the annular nozzle. The invention also relates to the use in the thrombectomy technique.

Description

[0001] Thrombectomy catheter device

[0002] The invention relates to a thrombectomy catheter device comprising a catheter tube unit with a suction lumen and a pressure fluid lumen, and a pressure fluid nozzle assembly in a distal end region of the catheter tube unit. The pressure fluid nozzle assembly is configured to emit a pressure fluid guided in the pressure fluid lumen as a tissue-shredding pressure fluid jet into a distal suction area of ​​the suction lumen. The pressure fluid nozzle assembly includes an annular nozzle with an annular cavity into which the pressure fluid lumen opens and which surrounds at least a portion of the distal suction area of ​​the suction lumen, and a plurality of nozzle openings extending from the annular cavity on a radial inner surface of the annular nozzle.

[0003] Thrombectomy catheter devices of this type and similar designs are used in thrombectomy to remove thrombi and other deposits from body tissues in humans and animals. The thrombus or deposit is fragmented by a pressurized fluid jet, and the resulting fragments are aspirated through the suction lumen. As is customary, the distal direction refers to the forward direction of the device, while the reverse, posterior direction is called the proximal direction. Consequently, in use, the device is inserted into a body tissue channel with its distal end first. The proximal end typically features an operating area for user control. The pressurized fluid can be, for example, water or a water-based saline solution.

[0004] In a known type of thrombectomy catheter device, the pressurized fluid flows along the inner or outer surface of a catheter tube providing the suction lumen, also referred to as an aspiration catheter tube or simply aspiration catheter. The pressurized fluid lumen has a nozzle opening in its distal end region that opens laterally and radially inward toward the suction lumen. Through this nozzle, the pressurized fluid jet is emitted into the suction lumen with a radially inward directional component and, optionally, with an additional axially posteriorly directed component. Devices of this type are disclosed, for example, in US patents 8,900,179 B2 and EP 2,362,751 B1.

[0005] In another known type of thrombectomy catheter device, the pressurized fluid lumen has an axially forward-facing nozzle opening or an axially backward-facing nozzle opening to emit the pressurized fluid jet axially forward or axially backward, respectively. In the latter case, the pressurized fluid lumen is deflected in an arc by 180° at its distal end. Devices of this type are disclosed, for example, in patent specification EP 0485133 B1 and publication EP 0175096 A1.

[0006] US patent 4950238 A discloses a thrombectomy catheter device in which the pressure fluid nozzle arrangement comprises a dome-shaped, rotating nozzle head having first openings for effecting the rotational movement and second nozzle openings that are obliquely directed forward and outward, emitting the pressure fluid jet accordingly in a radially outward and axially forward direction.

[0007] German patent application DE 40 18 736 A1 discloses a generic thrombectomy catheter device in which the annular nozzle is formed by a nozzle tube closed at one end, which extends in an open ring shape, i.e., over less than 360°, along a distal end face of a catheter tube and is rigidly connected to it. The nozzle tube is part of a curved tube section that is inserted at a proximal end into a distal end of the pressurized fluid lumen, the pressurized fluid lumen being formed as a hollow channel inside a tube wall of the catheter tube.

[0008] The invention addresses the technical problem of providing a thrombectomy catheter device of the type mentioned above, which offers further advantages over the prior art mentioned above, particularly with regard to reduced manufacturing costs and / or improved functionality concerning tissue fragmentation. The invention solves this problem by providing a thrombectomy catheter device with the features of claim 1. Advantageous embodiments of the invention are specified in the dependent claims, the wording of which is hereby incorporated into the description by reference. This includes, in particular, all embodiments of the invention resulting from the combinations of features defined by the cross-references in the dependent claims.

[0009] The thrombectomy catheter device according to the invention, also referred to as a thrombectomy catheter instrument, offers functional and manufacturing advantages over the pressure fluid nozzle arrangements of the prior art mentioned above, due to its special design of the pressure fluid nozzle arrangement. The annular nozzle can be manufactured with comparatively little effort, and it has been shown that a reliable and effective tissue-shredding function can be achieved with the pressure fluid jet, which is composed of the individual jets emitted from the multiple nozzle openings.

[0010] The pressurized fluid, guided as usual from a proximal section of the thrombectomy catheter device to the distal region, first enters the annular cavity. From there, it is emitted as a jet of pressurized fluid through multiple nozzle openings into the distal suction area of ​​the aspiration volume. The interposition of the annular cavity, in conjunction with the arrangement of the multiple nozzle openings on the radial inner side of the annular nozzle, proves optimal for the desired function of fragmenting thrombi and other tissue deposits. Depending on the pressure applied to the pressurized fluid, the device can fragment relatively soft or harder thrombi and deposits. The resulting fragments are then expelled proximally through the suction lumen and out of the device.can be withdrawn from the instrument. The operating pressure used for the pressure fluid is typically in the range between 5 bar and 20 bar, but can also be below 5 bar or above 20 bar depending on requirements and application. According to a first aspect of the invention, the annular nozzle and thus the annular cavity it forms is designed in a closed ring shape, i.e., as an annular nozzle extending continuously over 360° in the circumferential direction.

[0011] Alternatively, the annular nozzle can also have an open ring shape, i.e., extend over a circumferential angle range of less than 360°, if this is sufficient for the relevant applications or proves advantageous. The circumferential angle range of the open ring shape is preferably at least approximately 45°, more preferably more than 180°. Considering its intended application, the annular nozzle typically has a diameter of, for example, between approximately 2 mm and approximately 5 mm. The annular cavity typically has an axial extent or width in the range of, for example, approximately 0.3 mm to approximately 1.5 mm. In exemplary embodiments, the respective nozzle opening has a longitudinal extent or diameter in the range of approximately...

[0012] 0.01 mm to approximately 0.5 mm. The opening cross-section of the respective nozzle orifice is typically in the range of approximately 0.001 mm². 2 up to approximately 0.01 mm 2 .

[0013] According to a second aspect of the invention, the annular nozzle is composed of an inner ring part and an outer ring part surrounding it, forming the intermediate annular cavity. The construction of the annular nozzle from at least two parts, the inner ring part and the outer ring part, can be advantageous in many cases, particularly in the case of more complex nozzle geometries or in cases where these individual parts can be manufactured very easily.

[0014] According to a third aspect of the invention, the annular nozzle has at least one pressure relief opening that extends from an outer surface of the annular nozzle through the annular nozzle to its radial inner surface. This measure helps prevent tissue damage. If the thrombectomy catheter device, with the distal end of its catheter tubing unit or the annular nozzle located there, adheres to a vessel wall or the like, and the suction pressure is not reduced sufficiently in time, the vessel wall may be subjected to increased suction pressure. This is counteracted by the pressure relief opening, which provides a gas- and fluid-permeable connection from the external environment of the catheter tubing unit to the interior of the annular nozzle, thus relieving such increased suction pressure.Preferably, the pressure relief opening opens into the annular nozzle interior at an axial height between the annular cavity and the distal end face of the annular nozzle. Preferably, the annular nozzle includes several such pressure relief openings, e.g., arranged evenly distributed in the circumferential direction.

[0015] The three aforementioned aspects of the invention can be implemented individually or in any combination in appropriate embodiments.

[0016] It has been shown that for the desired tissue-shredding function, it is generally advantageous if the individual jets forming the pressure fluid jet, emitted from the respective nozzle openings, have a radial directional component and are emitted from nozzle openings that are significantly spaced apart from each other in the circumferential direction. This allows the tissue to be simultaneously impacted and thus processed by the pressure fluid jet at several significantly spaced points in the circumferential direction.

[0017] In comparison to devices with only one nozzle opening, the thrombectomy catheter device according to the invention enables significantly more effective tissue fragmentation functionality due to the multiple nozzle openings of its ring nozzle. Preferably, the ring nozzle has three or more nozzle openings.

[0018] Depending on requirements and application, the annular nozzle can be made entirely or partially from a metal, ceramic, and / or plastic material. It can be manufactured using conventional methods, such as mechanical processes like machining a blank by turning, 3D printing, sintering, or injection molding. The annular nozzle is securely attached to the distal end of the catheter tubing assembly, particularly to another component of the assembly located there, such as the catheter tubing that provides the suction lumen. Attachment can be achieved, for example, by welding, bonding, encasing, or casting.

[0019] In a further development of the invention, the nozzle openings are arranged equidistantly around the circumference. This arrangement of the nozzle openings allows the tissue to be processed simultaneously across its entire circumference, thus supporting optimal shredding. In alternative embodiments, the nozzle openings can be arranged with different circumferential spacings if this is advantageous for specific applications.

[0020] In a further development of the invention, the nozzle openings are arranged axially at the same height. With this arrangement of the nozzle openings, the tissue to be shredded can be processed very effectively at a specific axial height by the pressurized fluid jet.

[0021] In a further development of the invention, at least two of the nozzle openings are arranged axially offset. In corresponding applications, this arrangement of the nozzle openings enables the processing of the tissue to be shredded by the pressurized fluid jet simultaneously at several axially offset points.

[0022] In a further development of the invention, at least one of the nozzle openings is arranged axially offset from an axial center line of the ring nozzle. Depending on requirements, the offset can be oriented proximal or distally, thereby further optimizing the effect of the pressurized fluid jet on the tissue to be removed for certain applications.

[0023] In a further embodiment of the invention, at least one of the nozzle openings for emitting the pressure fluid jet is configured with a radial directional component. In a further embodiment of the invention, at least one nozzle opening for emitting the pressure fluid jet is configured with an axial directional component. In a further embodiment of the invention, at least one nozzle opening for emitting the pressure fluid jet is configured with a circumferential directional component. These various possible orientations of one or more of the nozzle openings according to the aforementioned embodiments can each be optimally adapted or selected for the desired application. If the pressure fluid jet extends with a radial directional component, it can act radially on the tissue to be shredded. If the pressure fluid jet extends specifically with a radial primary directional component, i.e.,With a directional component that is larger in the radial direction than in the perpendicular directions, the primary effect on the tissue to be shredded can be radial. When the pressure fluid jet is oriented with an axial directional component, it can, preferably in addition to a radial directional component, also act axially on the tissue to be shredded. Similarly, when the pressure fluid jet is oriented with a circumferential directional component, it can, preferably in addition to a radial directional component, also act circumferentially on the tissue to be shredded.

[0024] In a further development of the invention, at least one of the nozzle openings has a polygonal, circular, or oval cross-section. Depending on the application, this cross-sectional dimensioning of one, more, or all nozzle openings proves advantageous for achieving a corresponding jet effect.

[0025] In one embodiment of the invention, at least one of the nozzle openings has a rectangular cross-section with a larger axial dimension than circumferential dimension, or with a larger circumferential dimension than axial dimension. These dimensioning variants for one, several, or all nozzle openings prove advantageous for corresponding applications.

[0026] In a further development of the invention, at least one of the nozzle openings has a transverse extent that is smaller than a longitudinal extent. The longitudinal direction denotes the main exit direction of the pressurized fluid jet exiting the nozzle opening. It is shown that such a dimensioning of the nozzle opening leads to the formation of an optimal pressurized fluid jet for most applications.

[0027] In a further development of the invention, the ring nozzle is a single piece. The one-piece manufacturing of the ring nozzle saves the need to assemble several nozzle parts and can be done, for example, by 3D printing technology or an injection molding process.

[0028] In a further development of the invention, the inner ring part is cylindrical, and the outer ring part has a U-shaped cross-section. In another embodiment of the invention, the outer ring part is cylindrical, and the inner ring part has a U-shaped cross-section. The required annular cavity is provided by the U-shaped cross-section of either the outer or the inner ring part. In another embodiment of the invention, both the inner and outer ring parts have an L-shaped cross-section. These different configurations for the inner and outer ring parts can each offer manufacturing advantages. With regard to reducing manufacturing costs, the cylindrical design of the inner ring part in combination with the U-shaped design of the outer ring part proves to be particularly advantageous.The annular design of the inner or outer ring section has the particular advantage that the part in question can be supplied very simply as a corresponding pipe or hose section. If the inner and outer ring sections each have an L-shaped cross-section, these two parts can be manufactured in the same or a similar manner. They are then assembled so that the required annular cavity is formed between them.

[0029] In a further development of the invention, the catheter tubing unit comprises a catheter tubing containing the suction lumen and a pressure tubing containing the pressure fluid lumen, which is arranged on an inner or outer surface of the catheter tubing or within a wall of the catheter tubing. In these embodiments, the suction lumen on the one hand and the pressure fluid lumen on the other are thus provided by separate tubing, the catheter tubing and the pressure tubing, respectively. For this purpose, the pressure tubing is attached to the inside or outside of the catheter tubing in a suitable, known manner, e.g., by welding or bonding, or embedded in or encased within a wall of the catheter tubing.

[0030] In a further development of the invention, the catheter tubing unit comprises a multi-lumen catheter tube, which includes the suction lumen as one lumen and the pressure fluid lumen as another. In this embodiment, the catheter tube provides both the suction lumen and the pressure fluid lumen, for which purpose it is suitably designed as a multi-lumen tube. Thus, for example, a central lumen with a larger cross-section can function as the suction lumen and an off-center, peripheral lumen with a smaller cross-section can function as the pressure fluid lumen.

[0031] In one embodiment of the invention, the annular nozzle is composed of an inner ring part and an outer ring part surrounding it, forming the intermediate annular cavity. The outer ring part is formed by an associated section of the multi-lumen catheter tubing. This embodiment has the advantage that the distal end region of the multi-lumen catheter tubing provides the outer ring part, thus eliminating the need to manufacture a separate outer ring part. The inner ring part is suitably attached radially to the distal end section of the multi-lumen catheter tubing within the distal section that provides the outer ring part, for example, by welding, gluing, casting, or pressing.

[0032] In a further development of the invention, the ring nozzle has a funnel-shaped widening at its distal end. This design of the ring nozzle has the advantage that it offers comparatively little resistance to the tissue to be macerated when the tissue is brought into the effective area of ​​the ring nozzle, and thus also into the distal suction area of ​​the suction lumen, by appropriately moving the catheter hose assembly. Similarly, this design of the ring nozzle facilitates the entry of fragments of the macerated tissue into the suction lumen located proximally to the ring nozzle.

[0033] Advantageous embodiments of the invention are illustrated in the drawings. These and further embodiments of the invention are explained in more detail below. The drawings show:

[0034] Fig. 1 shows a schematic side view of an embodiment of the thrombectomy catheter device according to the invention, wherein only the components of interest here are shown.

[0035] Fig. 2 shows a perspective view of a ring nozzle and a pressure hose of the device from Fig. 1.

[0036] Fig. 3 is a longitudinal sectional view along a line 13-13 from Fig. 1,

[0037] Fig. 4 shows a cross-sectional view of an inner ring part of the ring nozzle from Fig. 2.

[0038] Fig. 5 is a side view of a modification of the inner ring part of Fig. 4 with axially off-center instead of axially centered arrangement of nozzle openings; Fig. 6 is the view of Fig. 5 for a modification of the inner ring part with slot openings extending axially instead of circumferentially as nozzle openings.

[0039] Fig. 7 shows the view of Fig. 5 for a modification of the inner ring part with circular nozzle openings,

[0040] Fig. 8 shows the view of Fig. 5 for a modification of the inner ring part with axially offset nozzle openings,

[0041] Fig. 9 shows the view of Fig. 5 for a modification of the inner ring part with obliquely extending nozzle openings,

[0042] Fig. 10 shows a longitudinal sectional view of the inner ring part of Fig. 9.

[0043] Fig. 11 shows a detailed view of area XI of Fig. 10.

[0044] Fig. 12 shows a longitudinal sectional view of a modification of the ring nozzle of Fig. 3 with a rounded distal end.

[0045] Fig. 13 shows the longitudinal section view of Fig. 12 for a modification of the ring nozzle with a funnel-shaped distal end region,

[0046] Fig. 14 shows the longitudinal section view of Fig. 3 for a modification with a pressure hose arranged on the inside instead of the outside of a catheter tube,

[0047] Fig. 15 shows the longitudinal section view of Fig. 14 for a modification with a pressure hose arranged in a wall of the catheter tube,

[0048] Fig. 16 shows a cross-sectional view of the catheter tube with the pressure hose arranged in its wall according to Fig. 15.

[0049] Fig. 17 shows a partial longitudinal sectional view of a modification of the ring nozzle of Fig. 3 with a tubular cylindrical outer ring section instead of a U-shaped cross-section and a U-shaped inner ring section instead of a tubular cylindrical cross-section; Fig. 18 shows the view of Fig. 17 for a modification with an L-shaped inner ring section and outer ring section.

[0050] Fig. 19 shows the view of Fig. 17 for a modification with a tubular cylindrical inner ring part and a U-shaped outer ring part in cross-section and wider nozzle openings,

[0051] Fig. 20 shows the longitudinal section view of Fig. 3 for a modification with a multi-lumen catheter tube and an integrated pressure fluid lumen.

[0052] Fig. 21 shows a longitudinal sectional view analogous to Fig. 3 along a different section plane for a modification with pressure relief openings in the annular nozzle and

[0053] Fig. 22 is a cross-sectional view along line XXII-XXII of Fig. 21.

[0054] As can be seen from the figures, which illustrate advantageous exemplary embodiments, the thrombectomy catheter device according to the invention comprises a catheter tube unit 1 and a pressure fluid nozzle assembly 4, which is arranged in a distal end region 1a of the catheter tube unit 1. The catheter tube unit 1 includes a suction lumen 2 and a pressure fluid lumen 3. The pressure fluid nozzle assembly 4 is configured to emit a pressure fluid, e.g., water or a water-based saline solution, guided in the pressure fluid lumen 3, as a tissue-shredding pressure fluid jet DS, schematically depicted in Figures 11 and 17 to 19, into a distal suction area 2a of the suction lumen 2.

[0055] The suction area 2a here refers to the area up to which, during operation of the thrombectomy catheter device, the suction action exerted proximally via the suction lumen 2 extends distally to remove fragments of the fragated tissue posteriorly from a body tissue channel into which the device, with its catheter tube unit 1, is advanced up to the tissue to be fragged and removed, such as a thrombus or the like. As is known per se, the suction lumen 2 can, in particular, be formed by a central lumen of the catheter tube unit 1, while the pressure fluid lumen 3 is typically formed by an off-center lumen of the catheter tube unit 1 with a smaller cross-section than the suction lumen 2.

[0056] As can be seen from the figures, the pressure fluid nozzle arrangement 4 in the thrombectomy catheter suction device according to the invention comprises an annular nozzle 5, which has an annular cavity 6 and a plurality of nozzle openings 7 extending from the annular cavity 6 on a radial inner surface 5a of the annular nozzle 5. The annular cavity 6 surrounds at least a part of the distal suction area 2a of the suction lumen 2, with the pressure fluid lumen 3 opening into the annular cavity 6. Thus, the pressure fluid supplied via the pressure fluid lumen 3 enters the annular cavity 6 of the annular nozzle 5 and can be emitted from there through the multiple nozzle openings 7 as the tissue-shredding pressure fluid jet DS into the distal suction area 2a of the suction lumen 2.

[0057] The annular nozzle 5 preferably connects radially flush to the distal end of the catheter tubing unit 1 and can be fixed to the distal end section 1a of the catheter tubing unit 1 in a conventional manner, e.g., by welding, gluing, pressing, shrinking, or crimping. Depending on requirements and application, the annular nozzle 5 is made entirely or partially of a metal, ceramic, or plastic material. Depending on its design, any suitable conventional manufacturing process, such as mechanical manufacturing, 3D printing, sintering, and injection molding, is appropriate for the production of the annular nozzle 5.

[0058] Consequently, the pressurized fluid jet DS, as provided by the thrombectomy catheter device according to the invention, comprises several individual jets, each emitted from one of the pressurized fluid openings 7, with which the pressurized fluid can be directed onto the tissue to be fragmented from different directions. This provides the thrombectomy catheter device according to the invention with a very effective tissue fragmentation functionality. The number of nozzle openings 7 can be selected appropriately depending on requirements and application. In the examples shown, the pressurized fluid nozzle arrangement 4 comprises three nozzle openings 7; in alternative embodiments, it comprises only two nozzle openings 7 or four, five, six, or more nozzle openings 7. In corresponding implementations, the nozzle openings 7 are arranged equidistantly in the circumferential direction, as in the examples shown.The circumferential direction here refers to the circumference of the ring nozzle 5 and the catheter tube unit 1. The ring nozzle 5 can, as in the examples shown, extend in a closed ring shape over the entire circumferential angle of 360°; in alternative designs, the ring nozzle 5 forms an open ring shape, i.e., it extends only over a circumferential angle of less than 360°, e.g., only over approximately 90°, approximately 180°, approximately 270°, or any other circumferential angle of less than 360° that is optimal for the respective application.

[0059] In corresponding implementations, the nozzle openings 7 are arranged axially at the same height. This is the case in the examples shown, with the exception of the embodiment in Fig. 8. The axial direction here refers to the axial direction or longitudinal direction of the annular nozzle 5 and the catheter tube assembly 1. In alternative embodiments, at least two nozzle openings 7i and 72 are arranged axially offset from one another. This is the case in the embodiment in Fig. 8, and a corresponding axial offset AV1 is shown in Fig. 8. In the embodiment shown there, a third nozzle opening 76 is arranged axially centrally between the two nozzle openings 7i and 72, i.e., with an axial offset to each of these two nozzle openings 7i and 72 that is half the size of the offset AV1 between the two nozzle openings 7i and 72.

[0060] In corresponding implementations, at least one nozzle opening 75 of the several nozzle openings 7 is arranged axially offset from an axial center line 5M of the annular nozzle 5. This is the case in the embodiments shown in Figs. 5 to 10 and in Fig.

[0061] 5 is explicitly shown as axial offset AV2. Depending on requirements and application, the nozzle opening in question can be offset 75 in the proximal direction or alternatively in the distal direction relative to the axial centerline 5M.

[0062] In corresponding embodiments, at least one nozzle opening 73 of the nozzle openings 7, preferably several or all nozzle openings 7, is configured to emit the pressure fluid jet DS with a radial directional component SR. This applies to all illustrated embodiments and is explicitly stated as representative of the nozzle opening 7 or 73 shown in Fig. 17. The radial directional component SR is explicitly stated in Figs. 11 and 17 to 19.

[0063] In corresponding embodiments, at least one nozzle opening 74 of the nozzle openings 7, preferably several or all nozzle openings 7, is configured to emit the pressure fluid jet DS with an axial directional component SA. This is the case in the embodiment shown in Figures 9 to 11 and is explicitly depicted in Figure 11. For this purpose, in this embodiment, the relevant nozzle opening 74 is designed with a correspondingly inclined profile in the annular nozzle 5. As explicitly shown in Figure 11, the nozzle opening 74 formed an angle α in its longitudinal direction DL with respect to the axial or longitudinal direction of the annular nozzle 5 or the catheter tube assembly 1. In the example shown, the angle α is approximately 135°; in alternative embodiments, it can have any other value greater than 0° and less than 90° or greater than 90° and less than 180°.

[0064] Depending on requirements and application, the radial directional component SR of the pressure fluid jet DS can be smaller, larger, or equal to the axial directional component SA. In the examples shown, with the exception of the example in Figures 9 to 11, the nozzle openings 7 are configured to emit the pressure fluid jet DS in the radial direction; that is, emission occurs exclusively in the radial direction from the annular cavity 6 through the nozzle openings 7 into the extraction area 2a of the extraction lumen 2.

[0065] In this context, the term "jet direction" always refers to the main jet direction of the pressure fluid jet DS, even if individual jet regions, due to a divergent jet path as illustrated in Figures 17 to 19, or a convergent jet path, additionally possess a directional component perpendicular to it, i.e., a directional component in the axial direction and / or in the circumferential direction. In alternative embodiments not shown, at least one of the nozzle openings 7 for emitting the pressure fluid jet DS is configured with a directional component in the circumferential direction.

[0066] In corresponding embodiments, at least one of the nozzle openings 7 is designed such that it has a polygonal, circular, or oval cross-section. In the embodiment shown in Fig. 7, the nozzle openings 7 have such a circular cross-section; in the other embodiments, the nozzle openings 7 have a polygonal cross-section, specifically a square cross-section. Alternatively, a triangular, pentagonal, hexagonal, etc., cross-section is also possible.

[0067] In certain embodiments, at least one of the nozzle openings 7 has a rectangular cross-section with a larger axial dimension than circumferential dimension. This is the case for the nozzle openings 7 in the embodiment shown in Fig. 6. In alternative embodiments, at least one of the nozzle openings 7 has a rectangular cross-section with a larger circumferential dimension than axial dimension. This is particularly the case for the nozzle openings 7 in the embodiments shown in Figs. 1 to 5 and 8 to 15. The rectangular nozzle openings 7 can, for example, each have a length of approximately 0.15 mm and a width of approximately 0.04 mm; other dimensions are, of course, expedient and possible as required.

[0068] In certain embodiments, at least one of the nozzle openings 7 has a transverse extent 7Q that is smaller than a longitudinal extent 7L. This is particularly the case for the nozzle openings 7 in the embodiments shown in Figures 9 to 11, 17, and 18. The longitudinal extent denotes the channel length of the respective nozzle opening 7, measured from the annular cavity 6 to the suction lumen 2 or to its distal suction area 2a. Figure 19 shows an embodiment in which the transverse extent 7Q is increased compared to the other embodiments, such as those in Figures 17 and 18, while the longitudinal extent 7L remains the same, and is approximately equal to the longitudinal extent 7L. As shown, this results in a greater width of the pressure fluid jet DS.

[0069] In advantageous embodiments, the annular nozzle 5, as in the examples shown, is composed of an inner ring part 8, 8' and an outer ring part 9, 9' surrounding it, forming the intermediate annular cavity 6. In alternative embodiments not shown, the annular nozzle 5 is manufactured as a single-piece component.

[0070] In advantageous embodiments, the inner ring part 8 is cylindrical, and the outer ring part 9 has a U-shaped cross-section. The outer ring part 9 is positioned around the inner ring part 8 in such a way that the annular cavity 6 is provided by the interior of the U-shaped cross-section. Figures 3, 12 to 15, 19, and 21 show exemplary embodiments with an annular nozzle 5 constructed in this manner.

[0071] In alternative embodiments, the outer ring part 9 is cylindrical, and the inner ring part 8 has a U-shaped cross-section. An example of this embodiment is shown in Fig. 17. As can be seen therein, in this case the inner ring part 8 has a U-shaped cross-section that points radially outwards, and the cylindrical outer ring part 9 abuts the inner ring part 8 radially on its outer surface, thus defining the interior of the U-shaped cross-section and forming the annular cavity 6.

[0072] The ring-cylindrical design of the inner ring part 8 or the outer ring part 9 has the advantage that the component in question can be manufactured very easily from a piece of tubing and no material-removing manufacturing process, such as turning or the like, is required.

[0073] In corresponding embodiments, the inner ring part 8 and the outer ring part 9 are formed with an L-shaped cross-section. Fig. 18 shows a corresponding embodiment. As can be seen therein, the inner ring part 8 and the outer ring part 9, with their L-shaped cross-sections pointing radially outwards and radially inwards respectively, are arranged radially against each other in such a way that they leave the ring cavity 6 between them.

[0074] In advantageous embodiments, the catheter tube unit 1 comprises a catheter tube 10 containing the suction lumen 2 and a pressure tube 11 containing the pressure fluid lumen 3, as shown for corresponding embodiments in Figures 1 to 3, 14, and 15. In corresponding embodiments, the pressure tube 11 is arranged on an outer surface 10b of the catheter tube 10, as in the embodiment of Figure 3. In other embodiments, the pressure tube 11 is arranged on an inner surface 10a of the catheter tube 10, as in the embodiment of Figure 14. In still other embodiments, the pressure tube 11 is arranged in a wall 10c of the catheter tube 10, as in the embodiment of Figures 15 and 16. The pressure tube 11 is in each case suitably connected to the catheter tube 10, e.g., by welding, gluing, wrapping, or embedding.The catheter tube 10 and the pressure tube 11 can be made of a metal, ceramic, or plastic material, depending on requirements and application. The pressure tube 11 can extend axially in a straight line or, as shown in the example of Fig. 1, helically within a shaft region of the catheter tube unit 1 between its distal end section 1a and a proximal end section (which is not relevant here and therefore not shown). The pressure tube 11 opens into the annular cavity 6 at its distal end and, if necessary, is chamfered at its distal end, as shown in the embodiments of Figs. 3 and 14.

[0075] In advantageous embodiments, the catheter tube unit 1, as in the embodiment shown in Fig. 20, has a multi-lumen catheter tube 12, which includes the suction lumen 2 as one lumen and the pressure fluid lumen 3 as another lumen. This eliminates the need for a separate pressure tube.

[0076] In advantageous embodiments of this type with a multi-lumen catheter tube 12, the annular nozzle 5, as shown in the example in Fig. 20, is composed of an inner ring part 8' and an outer ring part 9' surrounding the inner ring part 8', forming the intermediate annular cavity 6. The outer ring part 9' is formed by an associated section of the multi-lumen catheter tube 12, in particular a distal end section thereof. This eliminates the need for a separate outer ring part for the annular nozzle 5. The pressurized fluid lumen 3 of the multi-lumen catheter tube 12 opens at its distal end into the annular cavity 6, which is bounded radially inwards by the inner ring part 8' and radially outwards by the catheter tube 12.

[0077] In advantageous embodiments, the annular nozzle 5 has a funnel-shaped widening 13 at its distal end. Figures 13 and 20 show corresponding embodiments. The funnel-shaped widening 13 can facilitate the entry of the tissue to be shredded or fragments thereof. Additionally or alternatively, in corresponding embodiments, the annular nozzle 5 can be rounded at its distal end, as shown in Figures 12, 13, and 20 for corresponding embodiments.

[0078] In advantageous embodiments, the annular nozzle 5 has at least one pressure relief opening 14 extending from an outer surface 5b of the annular nozzle 5 through the annular nozzle 5 to its radial inner surface 5a, as is realized in the embodiment shown in Figures 21 and 22. Specifically, a plurality of pressure relief openings 14 are provided there, e.g., eight or alternatively another number of pressure relief openings 14. These are preferably arranged uniformly distributed in the circumferential direction of the annular nozzle 5. Figure 21 shows the distal end region 1a of the catheter tube assembly 1 in a section plane outside the pressure fluid lumen 3, which is therefore not visible in this illustration.

[0079] Preferably, the respective pressure relief opening 14 opens axially at the level between the annular cavity 6 and the distal end face of the catheter tube assembly 1 or the annular nozzle 5 into the annular nozzle interior surrounded by the annular nozzle 5. In corresponding embodiments, the respective pressure relief opening 14 extends, as in the example shown, in a purely radial direction between the annular nozzle interior and the radial outer surface of the annular nozzle 5 or the catheter tube assembly 1; alternatively, it can also extend with an additional directional component in the axial and / or circumferential direction.

[0080] The respective pressure relief opening 14 can prevent the suction-induced risk of tissue damage if the thrombectomy catheter device, with a distal end 1b of its catheter tube unit 1 or the annular nozzle 5 located therein, unintentionally adheres to a wall or similar of a vascular or tissue channel into which the catheter tube unit 1 has been inserted. Any suction pressure that may increase due to the suction against the wall can be avoided or reduced by the pressure relief opening, which allows a gaseous or fluid medium to pass through it from the external environment of the catheter tube unit to the interior of the annular nozzle.

[0081] As the illustrated and further embodiments explained above clearly demonstrate, the invention advantageously provides a thrombectomy catheter device which, compared to conventional devices of this type, has improved functionality with regard to tissue fragmentation, particularly due to the presence of the ring nozzle, and / or can be manufactured with relatively little effort compared to conventional devices of this and similar types.

Claims

Patent claims 1. Thrombectomy catheter device with - a catheter tube unit (1) with a suction lumen (2) and a pressure fluid lumen (3) and - a pressure fluid nozzle arrangement (4) in a distal end region (1a) of the catheter tube unit (1), wherein the pressure fluid nozzle arrangement (4) is configured to emit a pressure fluid guided in the pressure fluid lumen (3) as a tissue-shredding pressure fluid jet (DS) into a distal suction area (2a) of the suction lumen (2), and wherein the pressure fluid nozzle arrangement (4) comprises an annular nozzle (5) which has an annular cavity (6) into which the pressure fluid lumen (3) opens and which surrounds at least a part of the distal suction area (2a) of the suction lumen (2), and a plurality of nozzle openings (7) extending out of the annular cavity (6) on a radial inner surface (5a) of the annular nozzle (5), characterized by the fact that - the annular nozzle (5) with its annular cavity (6) is designed in a closed ring shape extending continuously over 360° in the circumferential direction and / or - the annular nozzle (5) is composed of an inner ring part (8) and an outer ring part (9) surrounding it, forming the intermediate annular cavity (6) and / or - the annular nozzle (5) has at least one pressure relief opening (14) which extends from an outer side (5b) of the annular nozzle (5) through the annular nozzle (5) to its radial inner side (5a).

2. Thrombectomy catheter device according to claim 1, further characterized in that - the nozzle openings (7) are arranged equidistantly in the circumferential direction and / or - the nozzle openings (7) are arranged axially at the same height or at least two (7^ 72) of the nozzle openings (7) are arranged axially offset and / or - at least one (75) of the nozzle openings (7) is arranged axially offset from an axial center line (5M) of the ring nozzle (5).

3. Thrombectomy catheter device according to claim 1 or 2, further characterized in that - at least one (73) of the nozzle openings (7) is configured to emit the pressure fluid jet (DS) with a radial directional component (SR) and / or - at least one (74) of the nozzle openings (7) is configured to emit the pressure fluid jet (DS) with an axial directional component (SA) and / or - at least one of the nozzle openings (7) is configured to emit the pressure fluid jet (DS) with a circumferential direction component.

4. Thrombectomy catheter device according to one of claims 1 to 3, further characterized in that at least one of the nozzle openings (7) has a polygonal or circular or oval cross-section.

5. Thrombectomy catheter device according to claim 4, further characterized in that at least one of the nozzle openings (7) has a rectangular cross-section with a larger extent in the axial direction than in the circumferential direction or with a larger extent in the circumferential direction than in the axial direction.

6. Thrombectomy catheter device according to one of claims 1 to 5, further characterized in that at least one of the nozzle openings (7) has a transverse extent (7Q) that is smaller than a longitudinal extent (7L).

7. Thrombectomy catheter device according to one of claims 1 to 6, further characterized in that the ring nozzle (5) is manufactured in one piece.

8. Thrombectomy catheter device according to one of claims 1 to 7, further characterized in that - the inner ring part (8) is formed in a ring-cylindrical shape and the outer ring part (9) is formed with an i-shaped cross-section or - the outer ring part (9) is formed in a ring-cylindrical shape and the inner ring part (8) is formed with an i-shaped cross-section or - the inner ring part (8) and the outer ring part (9) are formed with an e-shaped cross-section.

9. Thrombectomy catheter device according to one of claims 1 to 8, further characterized in that the catheter tube unit (1 ) has a catheter tube (10) containing the suction lumen (2) and a pressure tube (11) containing the pressure fluid lumen (3), which is arranged on an inner side (10a) of the catheter tube (10) or on an outer side (10b) of the catheter tube (10) or in a wall (10c) of the catheter tube (10).

10. Thrombectomy catheter device according to one of claims 1 to 8, further characterized in that the catheter tube unit (1) has a multi-lumen catheter tube (12) which includes as one lumen the suction lumen (2) and as another lumen the pressure fluid lumen (3).

11. Thrombectomy catheter device according to claim 10, further characterized in that the annular nozzle (5) is constructed from an inner ring part (8') and an outer ring part (9') surrounding it, forming the intermediate annular cavity (6), wherein the outer ring part (9') is formed by an associated section of the multi-lumen catheter tube (12).

12. Thrombectomy catheter device according to one of claims 1 to 11, further characterized in that the annular nozzle (5) has a funnel-shaped widening (13) at its distal end.

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