Device for the Enucleation of Intracorporeal Tissue Regions

Abstract

The invention is a device for the enucleation of intracorporeal tissue regions, in particular of the prostate, with a probe at whose distal end at least one freely accessible electrode body is mounted to which electrical energy can be applied via at least one electrical line running in the longitudinal extent of the probe. The electrode body has a dome-shaped electrode surface and has cross-sectional surfaces which are orientated orthogonally to the longitudinal extent of the probe surface areas along a first axial portion which contains a distal dome end of the electrode body, which increase continuously as the distance from the distal dome end increases.

Claims

1-29. (canceled)

30. A device for the enucleation of intracorporeal prostate tissue regions comprising: a probe including a rigid hollow cannula and a distal end with at least one freely accessible electrode body to which electrical energy is applied via at least one electrical line running longitudinally along the probe; the at least one accessible electrode body comprises a dome-shaped electrode surface element with cross-sectional surfaces orientated orthogonally to a longitudinal dimension of the probe with surface areas along first axial portion containing a distal dome end of the at least one accessible electrode body which continuously increase in cross-section as a distance from the distal dome end increases and cross-sectional surfaces including a peripheral edge are continuously differentiable; and at least in an area of the accessible electrode body distally connected to the probe, the probe body has a bending stiffness, which under an effect of a bending moment of at least 0.1 Nm acting on the electrode body transversely to a longitudinal extension of the probe, does not change shape.

31. The device according to claim 30, wherein: the peripheral edge of the cross-sectional surfaces of the electrode body is continually curved.

32. The device according to claim 31, wherein: the dome-shaped electrode surface along the first axial portion has a spatial shape corresponding to a spatial radiation intensity distribution of a laser beam with a Gaussian intensity distribution, a paraboloid or ellipsoid.

33. The device according to claim 30, wherein: the peripheral edge of the cross-sectional surfaces of the electrode body only has curved and straight peripheral edge sections.

34. The device according to claim 30, wherein: adjoins the first axial portion of the electrode body is a second axial portion of the electrode body and cross-sectional surfaces orientated orthogonally to the longitudinal extension of the electrode body do not change as distance from the distal dome end increases.

35. The device according to claim 30, wherein: in the first axial portion the electrode body has longitudinal sections orientated orthogonally to a cross-section surface which is delimited by a continuous peripheral edge.

36. The device according to claim 35, wherein: the peripheral edge is shaped as one of a circle, a parabola, a partial ellipse or a partial oval.

37. The device according to claim 30, wherein: the probe transmits at least one of thrust and pressure forces along a longitudinal extension of the probe.

38. The device according to claim 30, wherein: the hollow cannula is made of a metallic material.

39. The device according to claim 30, wherein: when in an area of the electrode body distally connected to the probe, the probe has a bending stiffness under an effect of a bending moment of at least 0.3 Nm acting on the electrode body transversely to the longitudinal extension of the probe, dimensions of the probe do not change.

40. The device according to claim 30, wherein: an area of the electrode body distally connected to the probe extends from its distal electrode tip to a maximum of 30 mm.

41. The device according to claim 30, wherein: the electrode body is made of one of metal or a metal alloy formed as a monopolar electrode electrically connected with an electrical line extending along the probe or formed as a bipolar electrode with two electrical lines extending along the probe.

42. The device according to claim 30, comprising: a guide sleeve extending along the probe for feeding a medical instrument in at least one of parallel to the probe and centering and sliding within and along a working channel of a resectoscope.

43. The device according to claim 30, wherein: at least the electrode surface of the electrode body is polished and honed.

44. The device according to claim 30, wherein: the electrode body is connected to the probe by a biocompatible, electrically insulating joint.

45. The device according to claim 44, wherein: at least one of an electrode surface of the electrode body, the joint and the probe is coated with a friction reducing coating.

46. The device according to claim 45, wherein: the coating comprises PTFE, TPU, polysiloxane or hydrogel.

47. The device according to claim 30, wherein: along a cross-sectional axis of a cross-section of the electrode body, the electrode body comprises two flattened electrode body surfaces.

48. The device according to claim 47, wherein: the two flattened electrode body surfaces comprise one of: both electrode body surfaces have at least one level surface area; both electrode body surfaces have at least one convexly curved surface area; one electrode body surface has at least one convexly curved surface area and an other electrode body surface has at least one concavely curved surface area; and one of the two electrode body surfaces has at least one curved surface area and the other electrode body surface has at least one concavely surface area.

49. The device according to claim 47, wherein: the electrode body is a spatula shaped.

50. The device according to 47, wherein: the electrode body has an oval-shaped cross-section which is symmetrical to a longitudinal axis of the oval cross-section.

51. The device according to claim 50, wherein: the oval-shaped cross-section is not symmetrical to an axis orthogonal to the longitudinal axis.

52. The device according to claim 47, wherein: the electrode body is shovel shaped with a flattened electrode body surface, which on a proximal side has a straight surface section which adjoins distally a convexly curved surface section; and the flattened electrode body surface is convexly curved and distally has a bulbous and rounded thickening.

53. The device according to claim 52, wherein: in axial projection to a rigid hollow cannula, the freely accessible electrode body does not radially protrude beyond the hollow cannula.

54. The device according to claim 52, wherein: the freely accessible electrode body has a cross-section which at least in sections has an outer shape of a figure eight.

55. The device according to claim 30, wherein: distally from the rigid hollow cannula, a spatula or shovel-shaped molded body is applied on which distally an accessible electrode body is mounted.

56. The device according to claim 55, wherein: the body comprises an electrically insulating material on which distally the accessible electrode body is mounted, or the body is made of an electrically conductive material on which is on an electrical insulator.

57. The device according to claim 55, wherein: the body is a shovel with a flattened electrode body surface, has a straight section on a proximal side, is convexly curved with an adjoining distally surface section; an other flattened electrode body surface is convexly curved; and the freely accessible electrode body has an adjoining bulbous or rounded thickening.

58. The device according to claim 55, wherein: the body has a cross-section which at least in sections has an outer shape of a figure eight.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0037] As an example, the invention will be described below, without restricting the general inventive concept, by way of examples of embodiment with reference to the drawings. In these:

[0038] FIGS. 1a, b show a side view and top view from above of a device in accordance with the invention;

[0039] FIGS. 2a, b show an example of embodiment of an electrode body in longitudinal section and viewed from below;

[0040] FIGS. 3a, b show an example of embodiment of an electrode body with a distal, additional dome structure;

[0041] FIGS. 4-7 show alternative spatial shapes of the electrode body along the first axial section;

[0042] FIGS. 8a-e show a longitudinal section a), longitudinal view rotated about 90° b) of an electrode body mounted on the probe, as well as cross-sections c), d), e);

[0043] FIGS. 9a-e show longitudinal section a), longitudinal view rotated about 90° b) of an alternative form of embodiment of an electrode body distally mounted on the probe as well as cross-sections c), d), e);

[0044] FIGS. 10a-c show a longitudinal section of an electrode body a), distally mounted on the probe, cross-sections b), c);

[0045] FIGS. 11a, b show a longitudinal section of an electrode body a) distally mounted on the probe, cross-section b); and

[0046] FIG. 12 shows a longitudinal section of an electrode body distally mounted on the probe.

DETAILED DESCRIPTION OF THE INVENTION

[0047] FIGS. 1a, b show a side view and view to a device for the enucleation of intracorporeal tissue regions. The device comprises a probe 1 configured as a hollow cannula, at whose distal end a freely accessible electrode body 2 is mounted. The electrode body 2 is connected to at least one, preferably two electrical lines 3, which extend proximally within the probe 1 and are configured to be connectable to an electrical energy source, which is not shown. Typically, a guide sleeve 4 is attached along the probe 1 which acts as a centering and sliding element within and along a working channel of a resectoscope, which is not shown in more detail, and also allows the feeding through of a medical instrument, which is an optical conductor. The electrically conductive electrode body 2 made of metal or a metallic material, comprises at least one axial portion 6, which has a dome-shaped electrode surface 5, which is spherical in the illustrated example of embodiment. In accordance with FIG. 1, the electrode body 2 comprises a second axial portion 6, which is configured in straight cylindrical form and seamlessly and smoothly adjoins the first axial portion 5.

[0048] The metallic electrode body 2 is firmly connected to probe 1, designed as a hollow cylinder, by way of a biocompatible, electrically insulating joint 7. The joint 7 is, for example, designed as a molded body for connection between the electrode body and the hollow cannula.

[0049] The curvature of the electrode surface of the electrode body 2 in the first axial portion 5 is constructively determined and optimally selected for the process of blunt preparation. In addition, preferred electrode surface geometries for creating the electrode body 2 are described.

[0050] In FIG. 2a, a longitudinal section through a bipolar electrode body 2 is shown, which for the purpose of electrical contacting envisages two electrical contact sleeves 8 into which the ends of the electrical lines 3 enter and are firmly connected to the electrode body 2. Additionally, the electrode body 2 is separated by an electrically insulating intermediate layer 13 into two electrode body halves 2′, 2″ that are electrically insulated from each other. In contrast, FIG. 2b shows a monopolar electrode body 2 with just one electrical contact sleeve

[0051] The electrode bodies 2 shown in FIGS. 2a, b each have a spherically dome shape along the first axial portion 5 which seamlessly and smoothly transforms into a straight cylindrical outer shape along the second axial portion 6.

[0052] The cross-sectional surfaces of the electrode bodies 2 which respectively are spherically formed along the first axial portion 5, correspond to circular areas each with continuously increasing circle diameters up to a circle diameter that corresponds to the diameter of the straight cylindrical outer shape along the second axial portion 6. The associated longitudinal sections through the electrode body 2 thus represent semicircular areas in the first axial portion 5.

[0053] FIG. 3a shows a shape variant designed of the electrode body 2, which in contrast to the spherical dome shape in accordance with FIGS. 2a, b, also has a smaller dome shape 10. The mamilla-like dome 10 is for supporting the pushing apart of two anatomical structure that are connected to each other by at least one of a connective tissue, vascularised tissue, or an avascularised tissue layer.

[0054] FIG. 3b shows a view from above of the distal end 9 of the electrode body 2 in proximal projection. The circular design of the mamilla-like dome shape can be seen from this illustration. The transition between the mamilla-like dome 10 and the remaining contour of the electrode body 2 within the first axial portion 5 takes place seamlessly and smoothly, that is the surface of the electrode body 2 is continuously differentiable at every point.

[0055] The shape of the dome-shaped electrode body 2 can diverge from the spherical dome-shaped design in accordance with the forms of embodiment in FIGS. 1 and 2.

[0056] FIGS. 4 to 6 show alternative spatial shapes for designing the electrode body 2 more particularly along the first axial section 5. FIG. 4 shows the spatial shape of a paraboloid and FIG. 5 is a replica of a Gaussian radiation intensity distribution which identically or approximately and in sections corresponds with the spatial shape of an ellipsoid.

[0057] FIG. 6 shows the special shape of a paraboloid, comparable with the illustration in FIG. 4, but which is supplemented with a mamilla-like additional dome shape 10 on the distal end of the electrode body 2.

[0058] FIG. 7a shows a perspective view of a further design form for shaping the electrode body 2 at least along the first portion 5. In this case the dome-shaped design of the electrode body is shovel-like or roundly flattened. Through the flattening of the electrode body 2 within the first portion 5 along the y-axis, see the x-y-z coordinate system shown in FIG. 7a, two opposite, flattened electrode surfaces 14, 15 are formed along the y-axis which are each moved in parallel, or largely in parallel between two tissue layers to the separated for the purpose of pushing apart both anatomical layer structures.

[0059] FIGS. 7b and 7c each show sectional views through the electrode body 2, respectively along the section plane z-y. See FIG. 7b along the section plane z-x. See FIG. 7c, on the continuous line in each case. The profile sections indicated with dashed lines in FIGS. 7b and 7c show, in a non-restrictive manner, variations for designing the spatial shape of the electrode body 2 illustrated in FIG. 7a.

[0060] FIGS. 7d and 7e also show possible alternative cross-sectional shapes A1 to A5, in the order of the section planes shown FIG. 7a.

[0061] In the case of the cross-sectional shapes in accordance with FIG. 7d, the electrode body 2 has cross-sectional shapes A1 to A5 in the first axial portion 5, which each have a straight section 11 as well as curved sections 12. With increasing distance from the distal end 9, the cross-sectional shapes A1 to A5 morphologically approximate a circular cross-section. The straight sections 11 are each assigned to the flattened electrode surfaces 14 15.

[0062] In the case of the cross-sectional shapes A1 to A5 illustrated in FIG. 7e, these are elliptical cross-sections whose cross-section dimensions continuously increase from the distal end 9 towards the proximal end. The slightly curved elliptical sections are assigned to the flattened electrode surfaces 14, 15.

[0063] In this case too, the elliptical cross-sectional shaped morphologically transition into a circular cross-section A6, which corresponds to the outer hollow cannula cross-section of the probe 1.

[0064] FIG. 8a shows a longitudinal section through a further form of embodiment for the enucleation of intracorporeal tissue regions with a probe 1 designed as a rigid hollow cannula, mounted at the distal end of which is an electrode body 2 to which electrical energy can be supplied via at least one electrical line 3 running in the longitudinal extent of the probe 1. By way of an electrical insulation layer 13 incorporated within the probe 1, the electrode body 2 is galvanically decoupled from the metallic probe wall. In addition, an electrically insulating ceramic sleeve body 16 surrounds the electrode body 2 distally projecting beyond the hollow cannula 1. The ceramic sleeve body 16 is flush with the outer contour of the hollow cannula 1. Area B of the electrical body 2, which distally projects beyond the electrically insulating ceramic sleeve body 16, is flattened, like the shape of a spatula, and comprises two electrode surfaces 14, 15, the shape of which can be seen by jointly looking at the longitudinal view in accordance with FIG. 8a and the side view in accordance with FIG. 8b which is turned about 90° with regard to FIG. 8a. Furthermore, possible spatial embodiments of the electrode body 2 are also evident with reference to the FIGS. 8c to 8e.

[0065] The distal end 17 of the spatula-shaped, flattened electrode body 2 has a distally rounded contour, to which two electrode surfaces 14, 15 seamlessly adjoin. The distal end 17 is also arranged eccentrically with regard to the longitudinal axis of the probe 18. The electrode surface 15 ends in a largely contour-maintaining manner on the outer wall of the proximally extending electrode body 2. The electrode surface 14, on the other hand, is curved in a shovel-like manner and radially seamlessly adjoins the face edge of the ceramic sleeve body 16, which is designed to maintain the contours of the shovel shape.

[0066] In practical application of the probe, the rounded end 17 ensures sparing displacement and separation of two tissue layers. The shape of the two electrode surfaces 14 and 15 as well as the proximally adjoining face-side contours of the ceramic sleeve body 16 allow for spatial distancing of the separated tissue regions.

[0067] In FIG. 8c a preferred cross-section through the electrode body 2 along section A-A in FIG. 8b is shown. Both electrode surfaces 14, 15, which are flattened along the y cross-section axis, are flat symmetrically to the x cross-section axis, and on their opposite surface ends along the y-axis are each connected by a rounded, preferably cylindrical surface shape 20, 21.

[0068] An alternative cross-sectional shape is illustrated in FIG. 8d. In this case the electrode surfaces 14, 15, are also designed to be symmetrical to the x cross-section axis, but flat and converging. The surface ends of both electrode surfaces 14, 15 are each connected via differently dimensioned cylindrical surface shapes 20, 21 of which the left surface shape 21 in the cross-sectional view according to FIG. 8d, has a greater curvature radius than the opposite surface shape 20. In the case of a lateral movement of the probe in the direction of the thicker surface shape 21, the broader or thicker, rounded surface shape 21 supports the separation process between two tissue layers, avoiding the consequences of cutting in the tissue.

[0069] FIG. 8e shows a further, alternative cross-sectional shape. In this case the electrode surface 15 is flat and the opposite electrode surface 14 is convex in design.

[0070] A variant of embodiment modified with regard to the embodiment shown above in FIGS. 8a, b, is illustrated in FIGS. 9a, b, which shows a longitudinal section view and a longitudinal view turned about 90°. In this case the area B of the electrical body 2 distally projecting beyond the ceramic sleeve body 16 radially and axially adjoins the outer wall of the ceramic sleeve body 16 in a flush manner, wherein the electrode surface 15 axially adjoins the outer wall of the ceramic sleeve body 16 in a flush manner, whereas the electrode surface 14 is curved in a shovel shape and has a center of curvature 19. The electrode body 2 shown in FIGS. 9a, b can also assume spatial shapes that are defined by the alternative cross-sections shown in FIGS. 9c to 9e as well as the cross-sections show in FIGS. 8c to 8e.

[0071] In all the examples of embodiment illustrated above, the entire surface area of the electrode body 2 is at least one of smoothly polished and honed, at least along area B. Preferably the electrode surface area of electrode body 2, the ceramic sleeve body 16 and the probe 1 are covered with a low-friction coating, preferably with a coating containing PTFE, TPU, polysiloxane or hydrogel.

[0072] FIG. 10a shows a longitudinal section through a further example of embodiment of a device according to the solution. In order to avoid repetition, components that are at least one of designed and act identically to already mentioned components, and are provided with already used and explained reference numbers.

[0073] The electrode body 2, comprising an electrically conductive and dimensionally stable material, preferably a metal or a metal alloy, is enclosed in a mechanically stable, torsion-free and rigid as well as electrically insulated manner within the hollow cannula 1 as well as the adjoining ceramic sleeve body 16. Area B of the electrode body 2, which distally projects from the ceramic sleeve body 16, is spoon-like or shovel-like in design. At its distal end 17, the electrode body 2 has a bulbous and rounded thickening 22. Proximally, the electrode surface 15 flushly adjoins the outer contour of the ceramic sleeve body 16. Via a section 1 the electrode surface 15 extends essentially in parallel, rectilinearly to the longitudinal extent of the ceramic sleeve body 16. Subsequent to this, the electrode surface 15 is convexly curved and at the distal end 17 merges into the bulbous and rounded thickening 22.

[0074] The electrode surface 14 is essential concavely formed in a spoon-like manner and on both of its longitudinal sides has bulbous edge contours 23, whose spatial shape can be seen in the cross-sectional view according to 10b along section plane B-B.

[0075] Through the bilateral superelevations on the electrode surface 14 resulting from the bulbous edge contours 23 vis-a-vis the concave recess arranged centrally to the longitudinal axis of the probe, this shape provides the electrode body 2 with increased dimensional or bending strength, particularly in the case of forces acting transversely to the longitudinal extent of the probe. The surface contour of the electrode surface 14 resembles the outer contour of a figure eight, whereas the opposite electrode surface 15 is flat.

[0076] In the distal area of the bulbous and rounded thickening 22, along the section line C-C visible in FIG. 10a, the electrode body 2 has the oval or elliptical cross-section shape shown in FIG. 10c.

[0077] The radial extent or spatial expansion of the electrode body 5, does not project beyond the radial dimension of the hollow cannula 1, which is defined by the outer diameter b, so that it is ensured that the entire probe can be fed unhindered through a working channel of a resectoscope which is dimensionally matched to the hollow cannula.

[0078] FIG. 11a shows a longitudinal section through a probe, which instead of the ceramic sleeve body 16 and the electrode body 2, as set out above with regard to FIG. 10, has a body 24 that projects into the hollow cannula 1 and is firmly connected to the hollow cannula 1, and that with the exception of the bulbous and rounded thickening 22 made of an electrically conductive material, is made of an electrical insulator, preferably a ceramic or a fiber-reinforced polymer, e.g. GFK, and otherwise has the shape of the electrode body 2 shown and described in the above FIGS. 10a, b. Extending through the body 24, is an electrical line assembly 3 that is connected to the electrically conducting thickening 22.

[0079] The cross-sectional view according to FIG. 11b, corresponds to the cross-section through the body 24 along section plane A-A in accordance with FIG. 11a and replicates the cross-section of the electrode body 2 along section plane B-B in accordance with FIG. 10b. A feedthrough channel for 25 for the electrical line assembly 3 in also provided in the cross-section.

[0080] The probe illustrated in FIG. 11a allows the limited as-needed application of electrical energy only to the areas of the bulbous and rounded thickening 22, and a thereby achievable coagulation effect on the surrounding tissue. All other surfaces of the body 24 are electrically inactive.

[0081] Alternatively to the embodiment of the insulating body 24, FIG. 12 shows a longitudinal section through an example of embodiment, in which the 24′ is made of a metallic, electrical conductive material. The body 24′ is firmly joined to the hollow cannula 1 or connected in one piece thereto. Distally on the metallic body 24′ an electrical insulator 25 is applied, to which, electrically insulated from the metallic body 24′, the bulbous and rounded thickening 22 made of a metallic material is applied, which via the electrical lead assembly 3, can be supplied as-needed with electrical energy. The metallic body 24′, the spatial shape of which essentially corresponds to that of the previously described body 24 in accordance with FIGS. 11a, b or electrode body 2 in accordance with FIG. 10a, possesses a high degree of robustness and bending strength, particularly in the case of one-piece or monolithic embodiment with the hollow cannula 1. Along the section line A-A, the metallic body 24′ has a cross-section equivalent to the cross-section in accordance with FIG. 11b.

LIST OF REFERENCE NUMBERS

[0082] 1 Probe, hollow cannula [0083] 2 Electrode body [0084] 3 Electrical line [0085] 4 Guide sleeve [0086] 5 First axial portion [0087] 6 Second portion [0088] 7 Joint [0089] 8 Contact sleeve [0090] 9 Distal end [0091] 10 Mamilla dome shape [0092] 11 Straight section [0093] 12 Curved section [0094] 13 Electrically insulating intermediate layer [0095] 14, 15 Electrode body surface [0096] 16 Ceramic sleeve body [0097] 17 Distal end [0098] 18 Longitudinal axis of the probe [0099] 19 Center of curvature [0100] 20, 21 Surface shape [0101] 22 Thickening [0102] 23 Bulbous edge contour [0103] 24 Electrically insulating bodies [0104] 25 Feedthrough channel