Insulation insert and hand-held surgical instrument

Abstract

To provide an insulation insert and a hand-held surgical instrument by which a human body is protected or load by the use of the hand-held device is reduced.SOLUTION: An insulating insert (23) for a hand-held surgical instrument (10) is tubular. The insulating insert (23) includes: coupling means (26) at a proximal end portion for releasably coupling to a distal end (25) of a tubular inner shaft (13) of the hand-held surgical instrument (10); and at least one flexible component (28) at an outer periphery.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to an insulating insert for a handheld surgical instrument, and to said handheld surgical instrument. [Background technology]

[0002] Surgical instruments of the type described herein, in particular resectoscopes, are used primarily in urology for electrosurgical work. These devices are typically used for the resection and vaporization of tissue, for example tissue of the lower urinary tract. For this purpose, handheld surgical instruments, in particular resectoscopes, can be equipped with a longitudinally displaceable electrosurgical channel instrument, the distal working end of which can be pushed out of the distal end of the axial tube of the handheld surgical instrument after the handheld surgical instrument has been inserted into the body of the subject. Here, the handheld surgical instrument has an electrosurgical electrode at its distal end. The electrode can include, for example, the form of a loop or a button.

[0003] In the above applications, a high-frequency current is applied to the electrode. It is important to prevent the electrode from coming into electrical contact with the axial tube of the handpiece, in particular the outer axial tube or the sheath tube. In the case of such electrical contact, a short circuit may affect the handheld surgical instrument or cause unexpected effects on the body of the subject to be treated. To avoid such short circuits, handheld surgical instruments or resectoscopes typically include a part made of an electrically insulating material in their distal end region or at their distal end. This part is also usually called the insulating tip or insulating insert. Here, the insulating insert can be attached either to the inner axial or axial tube, in which the electrode array is guided, or to the outer axial or sheath tube. Since these handheld surgical instruments or resectoscopes are designed for multiple uses and must be periodically sterilized or autoclaved, the insulating insert must meet high requirements for durability and reworkability. Therefore, the choice of material is usually limited to relatively expensive high-performance ceramics such as silicon nitride. As an alternative to these ceramics, electrically insulating plastics are used at least for disposable articles. These plastics are particularly thermally stable, so that they do not melt immediately when in contact with the electrode.

[0004] All of the above materials behave mechanically as stiff. This property can occur when inserting a handheld surgical instrument into the urethra. When the insulating insert or a part of the insulating insert comes into contact with the urethra, the force used to insert the handheld surgical instrument into the body and all other relative movements between the handheld surgical instrument and the body are immediately transmitted to the urethra or mucosa directly opposite this contact area. A particularly small contact area results in a large mechanical tension on the mucosa. This can inevitably lead to effects on the mucosa. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] China Utility Model No. 217090888 [Patent Document 2] China Patent Application Publication No. 114652425 [Patent Document 3] China Utility Model No. 215839434 [Patent Document 4] China Patent Application Publication No. 112932653 [Patent Document 5] U.S. Patent No. 6,071,283 Summary of the Invention [Problem to be solved by the invention]

[0006] SUMMARY OF THE PRESENT EMBODIMENTS Accordingly, it is an object of the present invention to provide an insulating insert and a handheld surgical instrument, the use of which provides protection to the body or reduces stress on tissue caused by use of the handheld surgical instrument. [Means for solving the problem]

[0007] A configuration for achieving this object is described by the features of claim 1. It is provided that an insulating insert for use in a handheld surgical device, in particular a resectoscope, is tubular and has at its proximal end a coupling means for detachably coupling to the distal end of the tubular shaft of the handheld surgical device. An important feature of the invention is that the outer periphery or edge of the insulating insert comprises at least one flexible component. This flexible component of the insulating insert is capable of damping mechanical forces between the urethra and the handheld instrument during insertion into the human body. Mechanical forces or tensions are distributed over a larger contact area with the mucosa, resulting in deformation of the flexible component. As a result, loads on the urethra can be avoided or at least reduced.

[0008] Preferably, at least one flexible component is provided on the outer circumference or edge of the distal end of the insulating insert. According to this embodiment, the insulating insert is in direct contact with the inside of the urethra or mucosa by means of the flexible component, which allows the forces to be distributed more uniformly over the contact area. The arrangement of the flexible component in the distal end area or at the distal end face of the insulating insert is particularly advantageous for the manufacture of the insulating insert. In addition, this arrangement of the flexible component allows for a particularly efficient absorption of forces.

[0009] In particular, the invention provides that the flexible component is made of silicone or elastomer. The insulating insert can be made of a rigid material, in particular ceramic or plastic. This choice of material ensures that the insulating insert meets the above requirements. At the same time, its combination with a flexible material allows the described objective to be achieved, allowing the handheld surgical instrument to be moved within the body in a particularly gentle manner relative to the body. When choosing the material for the flexible component, it is important for reusable devices that the material is particularly heat resistant and can be reprocessed more frequently.

[0010] A preferred embodiment of the invention may provide that the flexible component extends annularly around the entire circumference of the distal end. In this embodiment, the flexible component may be considered as an annular flexible extension of the insulating insert. The annular design of the flexible component ensures that mechanical forces are absorbed and loads are prevented every time the insulating insert contacts the mucosa. The orientation of the hand-held surgical instrument or the insulating insert relative to the urethra is irrelevant. This provides the surgeon with maximum flexibility in his work.

[0011] It is further contemplated that the flexible component has a hardness of 10 Shore A to 90 Shore A, preferably 30 Shore A to 70 Shore A. This hardness has been shown to be particularly suitable for the described applications.

[0012] Another alternative embodiment of the invention can provide that the flexible element extends over an angular range of 45° to 180°, in particular over an angular range of 90°, around the entire circumference of the distal end region. In particular, if the distal end region of the insulating insert is not planar, but is for example beak-shaped, it can be advantageous if only the most distally oriented part is provided with a flexible element. Depending on the design of the insulating insert, the flexible element can extend over a predefined angular range on the distal circumference.

[0013] Preferably, the flexible component is arranged on the outside or above and / or inside and / or in front of the distal end region and / or the flexible component is considered to extend in the direction of the proximal end on the outside. Depending on the design and the intended application of the handheld surgical device, it may be advantageous for the flexible component to extend over various parts of the distal end region of the insulating insert. The further the flexible component extends in the distal direction, the greater the force absorbing effect. According to the invention, it is considered that the flexible component has an axial length of 0.3 mm to 7.0 mm, preferably 0.5 mm to 2.0 mm.

[0014] In particular, it is conceivable that two, three or more flexible components are arranged along the circumference. In applications where there is an impact on the urethra and it is necessary to rely on a free edge in the distal region of the insulating insert, it may be envisaged that several individual flexible components are arranged along the circumference.

[0015] Furthermore, it may be a particularly preferred embodiment of the invention to have axial and / or radial or annular undercuts in the distal end region of the insulating insert in order to improve the adhesion of the flexible component. During the manufacture of the insulating insert, the component is molded onto the distal region. The undercuts provide the flexible component with a fixation that is strong enough to prevent the flexible component from loosening when radial or axial forces are applied. The undercuts increase the contact area between the flexible component and the insulating insert. This increase in the contact area also helps to stabilize the connection between the flexible component and the insulating insert. Depending on the design or embodiment of the insulating insert, it may be advantageous to arrange the undercuts axially, i.e. parallel to the longitudinal axis of the insulating insert, or radially, i.e. along the outer periphery. As an alternative to undercuts, it is also possible for the distal end region of the insulating insert to have holes or notches or other recesses in which the flexible component can be accommodated.

[0016] Finally, it is also conceivable that the flexible component and the outer shell surface of at least the distal part of the insulating insert form a continuous surface, which design can avoid snagging of the insulating insert in the urethra or difficulties in sufficiently reprocessing the insulating insert for reuse.

[0017] In order to achieve the above-mentioned object, a handheld surgical instrument has the features of claim 13. In particular, the handheld surgical instrument may be a resectoscope or the like. The claimed handheld surgical instrument comprises an inner shaft or shaft tube and an outer shaft or sheath tube. The sheath tube is arranged around the inner shaft. According to the invention, an insulating insert as claimed in claim 1 is detachably associated with the distal end of the inner shaft. Such an arrangement of insulating inserts at the distal ends of both the inner shaft and the outer shaft makes it possible to prevent an electrosurgical instrument or electrode led out of the insulating insert through the inner shaft from coming into electrical contact with the sheath tube made of metal.

[0018] Preferred embodiments of the invention are explained in more detail below with reference to the drawings. [Brief description of the drawings]

[0019] [Figure 1] 1 is a schematic diagram of a handheld surgical instrument, specifically a resectoscope. [Diagram 2] FIG. [Diagram 3] FIG. 3 is a cross-sectional view of the insulating insert according to FIG. 2; [Figure 4] FIG. 13 is a perspective view of a further embodiment of an insulating insert. [Diagram 5] FIG. 5 is a cross-sectional view of the insulating insert according to FIG. [Figure 6] FIG. 13 is a perspective view of a further embodiment of an insulating insert. [Figure 7] FIG. 7 is a cross-sectional view of the insulating insert according to FIG. [Figure 8] FIG. 2 is a cross-sectional view of a distal end region of an insulating insert. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] 1 shows a schematic cross-sectional view of a resectoscope 10. It should be expressly noted that the resectoscope 10 is shown only as one possible embodiment of the claimed handheld surgical instrument. Similarly, it is contemplated that the handheld surgical instrument may be an instrument other than the resectoscope 10 shown herein.

[0021] Resectoscope 10 has a resectoscope shaft 11 which includes an outer shaft 12 or sheath tube as shown. A tubular inner shaft 13 extends within outer shaft 12, and an electrode instrument 14 and optical elements 15 are shown within inner shaft 13. Additionally, other elements not shown herein may extend within resectoscope 10, such as a separate irrigation tube.

[0022] The electrode device 14 has an electrosurgical tool or electrode 16 at its distal end. The electrode 16 shown here is shown as a loop, but may also be formed as a button or the like. In Fig. 1 it can be seen that the electrode device 14 is protected against displacement, i.e. displacement away from the longitudinal direction of the resectoscope shaft 11, by a retaining element 17 having a part-circular cross section. The electrode device 14 is mounted longitudinally displaceable within the inner shaft 13. The retaining element 17 has a shape complementary to the inner wall of the inner shaft 13 or the outer wall of the optical element 15, and has a part-cylindrical shape.

[0023] The electrode tool 14 can be forcefully moved axially in the distal and proximal directions by actuating the gripper 18, thereby pushing it beyond the distal ends of the inner and outer shafts 13 and 12. This allows the surgeon to manipulate tissue further away from the tip of the resectoscope 10. Moreover, for this purpose, the inner shaft 13 and / or the electrode tool 14 may be rotatably mounted on their longitudinal axes. A high frequency current is applied to the electrode 16 for tissue manipulation.

[0024] The resectoscope 10 shown in FIG. 1 has a passive transport in which the relative movement of the grippers 20 and 21, located proximally on the resectoscope shaft 11, against a spring force applied by the spring bridge 22 displaces the slide 19 distally relative to the distal first gripper 21. Distal displacement of the slide 19 relative to the gripper 21 displaces the electrode instrument 14 distally in a manner not shown. When the grippers 20, 21 are unloaded, the spring force generated by the spring bridge 22 pushes the slide 19 back to its initial position and pulls the electrode instrument 14 proximally. Once the slide 19 is returned, the electrosurgical procedure can be performed with the electrode 16 without manual force from the operator, i.e. passively.

[0025] The insulating insert 23 is releasably coupled at its proximal end 24 to the distal end 25 of the inner shaft 13 (see for example FIG. 2 where only the distal region of the device is shown). For this purpose, the insulating insert 23 has coupling means 26 at its proximal end 24. To treat a patient, the resectoscope 10 is pushed into the patient's urethra with the insulating insert 23 in front. To prevent the above-mentioned effects on the urethra or mucous membrane, the outer periphery 27 of the insulating insert 23 has a flexible component 28. This flexible component 28 can be associated with the outer periphery 27 of the distal end 29 of the insulating insert 23, as shown in the embodiment example according to FIGS. 2 and 3. Thereby, in the embodiment example shown, the flexible component 28 can be considered as a kind of ring. According to the invention, this flexible component 28 is made of silicone, elastomer or another flexible material. During insertion of the resectoscope 10, if the insulating insert 23 with the flexible component 28 in front comes into contact with the mucosa, there is no impact, but rather an elastic deformation of the flexible component 28. Therefore, there is no deformation and final impact of the mucosa due to the transmitted mechanical stress. Since the insulating insert 23 is made of a rigid material such as ceramic, composite material, plastic, etc., the shape of the insulating insert 23 itself does not change, and the functionality of the resectoscope 10 is not hindered.

[0026] In the exemplary embodiment shown in Figures 2 and 3, the entire distal end 29 of the insulating insert 23 is surrounded by the flexible component 28, so that the urethral mucosa is protected regardless of the contact area of ​​the insulating insert 23.

[0027] Alternatively, it is equally conceivable that only a portion of the distal end 29 of the insulating insert 23 has the flexible component 28. For example, Figures 4 and 5 show an embodiment in which only the upper region of the outer edge or periphery 27 is provided with the flexible component 28. It can be seen that the flexible component 28 extends across the inner, front and outer sides of the distal end 29. Thus, the upper region of the periphery 27 is at least partially surrounded by the flexible component 28.

[0028] 6 and 7 show an embodiment in which this wrapping around the upper part of the periphery 27 is even more pronounced, where the flexible component 28 extends towards the proximal end 24 on the upper or lateral side or covering area 30 of the insulating insert 23. This expansion of the flexible component 28 allows it to absorb larger forces applied from the outside to the insulating insert 23 or mucosa.

[0029] According to the invention, it is provided that the flexible element 28 has a width of 0.3 mm to 7.0 mm, preferably 0.5 mm to 2.0 mm, in which case the flexible element 28 is dimensioned to be in one plane with the covering area 30 of the insulating insert 23, so that there is no constriction between the outer shaft 12 and the inner shaft 13.

[0030] For a particularly stable and firm connection between the flexible component 28 and the outer periphery 27 of the insulating insert 23, the outer periphery 27 may have an undercut 31. For example, as shown in FIG. 8, the outer periphery 27 of the distal end 29 may be associated with a radial undercut 31 having a rectangular cross section. This undercut 31 provides additional mechanical resistance to the flexible component 28, for example injection molded around the distal end 29, and prevents the flexible component 28 from undesirably detaching from the insulating insert 23 when an external force is applied. In FIG. 8, only a cross-sectional view of the wall 32 of the insulating insert 23 is shown. Alternatively or additionally, it is also conceivable that an axial undercut or several smaller radial undercuts are associated with the distal end region or the distal end 29 in order to further increase the stability of the connection between the flexible component 28 and the insulating insert 23. [Explanation of symbols]

[0031] 10 Resection scope 11 Resection scope axis 12 Outer shaft 13 Inner shaft 14 Electrode equipment 15 Optical elements 16 electrodes 17 Retention elements 18 Grip 19 Sliding part 20 Gripping part 21 Gripping part 22 Spring Bridge 23 Insulating insert 24 Proximal end 25 Distal end 26 Coupling means 27 Circumference 28 Flexible components 29 Distal end 30 Coverage Area 31 Undercut 32 Wall

Claims

1. 1. A tubular insulating insert for use in a handheld surgical instrument, comprising: a coupling means at a proximal end for releasably coupling to a distal end of a tubular inner shaft of the handheld surgical instrument; an insulating insert disposed around the outer periphery and comprising at least one flexible component;

2. The insulating insert of claim 1 , wherein the at least one flexible component is disposed about the outer periphery of a distal end of the insulating insert.

3. The insulating insert of claim 1 , wherein the flexible component is made of silicone or an elastomer and / or the insulating insert is made of ceramic or plastic.

4. The insulating insert of claim 2 , wherein the flexible component extends annularly around the entire circumference of the distal end.

5. The insulating insert of claim 1 , wherein the flexible component has a hardness of between 10 Shore A and 90 Shore A.

6. The insulating insert of claim 2 , wherein the flexible component extends over an angular range of 45° to 180° around the entire circumference of the distal end.

7. The insulating insert of claim 2 , wherein the flexible component is disposed on a portion of the circumference of the distal end that extends furthest in a distal direction.

8. 3. The insulating insert of claim 2, wherein the flexible component is located on the outside or above and / or inside and / or at the end of the distal end and / or the flexible component extends on the outside towards the proximal end.

9. The insulating insert of claim 1 , wherein two, three or more of the flexible components are disposed on the outer periphery.

10. The insulating insert of claim 1 , wherein the flexible component has an axial length of between 0.3 mm and 7.0 mm.

11. The insulating insert of claim 2 , wherein the distal end has axial and / or radial or annular undercuts for improving adhesion of the flexible component.

12. The insulating insert of claim 2 , wherein the flexible component and a coated area at least at the distal end of the insulating insert form a continuous surface.

13. An inner shaft and an outer shaft; The insulating insert according to claim 1, the insulating insert is removably coupleable to the inner shaft; The outer shaft is movable over the inner shaft and the insulating insert.

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