Hand-held surgical instrument and insulating insert for hand-held surgical instrument
By designing flexible components on the insulation plug in handheld surgical equipment, the mucosal injury problem caused by the concentration of the insulation plug -in and urethral contact timing is solved, and a more uniform force distribution and a smaller trauma risk are achieved.
Patent Information
- Application Number
- CN202410990427.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-07-26
- Filing Date
- 2024-07-23
- Publication Date
- 2025-01-28
AI Technical Summary
Insulated inserts of existing handheld surgical instruments, when in contact with the urethra, mechanical forces are concentrated to cause mucosal damage or trauma.
Design a tubular insulation plug -in, which includes at least one flexible component, which can weaken mechanical forces when inserting into the human body, and distributes in a larger contact area through the deformation of flexible components.
Effectively reduce or avoid the trauma of the urethra, reduce the risk of damage to the mucosa by uniformly distributed mechanical forces.
Smart Images
Figure CN119367038A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to an insulating insert for a handheld surgical instrument and a handheld surgical instrument. Background Art
[0002] Surgical instruments of the type described, in particular, resectoscopes, are mainly used in urology for performing electrosurgical operations. These devices are generally used for the excision and vaporization of tissues, for example, tissues in the lower urinary tract. For this purpose, the handheld instrument, in particular, the resectoscope, may comprise a longitudinally displaceable electrosurgical channel instrument, which, after the device is inserted into the body to be treated, can be pushed out of the distal end of the shaft tube of the handheld surgical instrument with its distal working end. In this regard, the electrosurgical penetrating instrument or electrode instrument has an electrosurgical electrode at its distal end. This electrode may comprise, for example, the form of a ring or a button, etc.
[0003] For the above-mentioned applications, a high-frequency current is applied to the electrode. It is important to prevent the electrode from being in electrical contact with the shaft tube (especially, the outer shaft tube or sheath tube) of the handpiece. If such electrical contact occurs, a short circuit may cause the device to malfunction or cause unforeseen damage to the body to be treated. In order to avoid such a short circuit, the handheld device or resectoscope usually includes a section made of an electrically insulating material at its distal region or portion. This section is usually called an insulating end or also called an insulating insert. Here, the insulating insert can be attached to the inner shaft or shaft tube in which the electrode array is guided or to the outer shaft or sheath tube. Since these handheld surgical instruments or resectoscopes are designed to be used multiple times and therefore must be sterilized or autoclaved regularly, the insulating insert must meet high requirements for durability and reprocessability. Therefore, the choice of materials 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 disposables. These plastics are particularly heat-resistant so that they do not melt immediately when in contact with the electrode.
[0004] The above materials are all mechanically rigid. This property is particularly problematic when inserting the device into the urethra. As soon as the insulating insert or a portion of the insulating insert comes into contact with the urethra, the forces used to insert the device into the body and all other relative movements between the device and the body are transmitted to the mucosa or urethra opposite this contact area. In particular, small contact areas lead to large mechanical tensions in the mucosa. This inevitably leads to damage or trauma to the mucosa. Summary of the invention
[0005] The invention is therefore based on the problem of creating an insulating insert and a handheld surgical instrument by means of which the body is protected or not traumatized by the use of the instrument.
[0006] The solution to this problem is described by the features of an insulating insert according to the present disclosure. Thus, an insulating insert for a handheld surgical instrument, in particular for a resectoscope, is provided, the insulating insert being tubular and having a coupling device at a proximal portion for releasably coupling to the distal end of a tubular shaft of the handheld surgical instrument. A key feature of the present invention is that the circumference or periphery of the tubular insulating insert comprises at least one flexible component. This flexible component on the insulating insert is capable of attenuating the mechanical forces between the urethra and the handheld surgical instrument during insertion of the handheld surgical instrument into the human body. The mechanical forces or tensions are distributed over a larger contact area with the mucosa and result in deformation of the flexible component. Thus, trauma to the urethra can be avoided or at least reduced.
[0007] Preferably, at least one flexible component is arranged at the circumference or periphery of the distal portion of the insulating insert. According to this embodiment, the insulating insert directly contacts the mucosa or the interior of the urethra via the flexible component, which results in a more uniform distribution of forces over the contact area. Positioning the flexible component at the distal region or distal face of the insulating insert is particularly advantageous for the manufacture of the insulating insert. Furthermore, by such a positioning of the flexible component, forces can be absorbed particularly efficiently.
[0008] In particular, the invention provides that the flexible component is made of silicone or an elastomer. The insulating insert can be made of a rigid material, in particular, of ceramic or plastic. By this choice of material, the insulating insert meets the above-mentioned requirements; at the same time, by combining it with a flexible material, the described problems can be solved and the device can be moved inside the body in a particularly gentle manner for the body. When choosing the material for the flexible component, it is important for reusable devices that it is particularly heat-resistant and can be reprocessed more frequently.
[0009] A preferred embodiment of the invention may provide that the flexible component extends annularly around the entire circumference of the distal portion. In this embodiment, the 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 whenever the insulating insert contacts the mucosa, thereby preventing trauma. The orientation of the instrument or the insulating insert relative to the urethra is irrelevant. This provides maximum flexibility for the surgeon's work.
[0010] It is also conceivable that the hardness of the flexible component ( 28 ) is 10 Shore A to 90 Shore A, preferably 30 Shore A to 70 Shore A. It has been shown that this hardness is particularly suitable for the described application.
[0011] Another alternative embodiment of the invention can provide that the flexible component extends over the entire circumference of the distal region within an angular range of 45° to 180°, in particular within an angular range of 90°. In particular, if the distal region of the insulating insert does not lie in a plane, but is, for example, beak-shaped, it can be advantageous if only the most distally directed part is provided with the flexible component. Depending on the design of the insulating insert, the flexible component can extend over the distal circumference within a defined angular range.
[0012] Preferably, it is conceivable that the flexible component is arranged on the outside or upper side and / or the inside and / or the front side of the distal region and / or that the flexible component extends on the outside in the proximal direction. Depending on the design of the handheld surgical instrument and the intended use, it may be advantageous for the component to extend to different parts of the distal region of the insulating insert. The further the flexible component extends in the distal direction, the greater the force absorption effect. According to the invention, it is conceivable that the flexible component has a length of 0.3 mm to 7.0 mm in the axial direction, preferably a length of 0.5 mm to 2.0 mm.
[0013] In particular, it is conceivable to arrange two, three or more flexible components along the circumference.For applications where there is a risk of trauma to the urethra and where reliance must be placed on the free edge of the distal region of the insulating insert, it is conceivable to arrange several individual flexible components along the circumference.
[0014] Furthermore, a particularly preferred embodiment of the invention may be that the distal region of the insulating insert has an axial and / or radial or annular undercut for improving the adhesion of the flexible component. During the manufacture of the insulating insert, the component is molded onto the distal region. The undercut provides a sufficiently strong anchoring for the flexible component to prevent the flexible component from loosening when radial or axial forces are applied. The undercut creates an increase in the contact area between the flexible component and the insulating insert. This enlargement of the contact area also serves to stabilize the connection between the flexible component and the insulating insert. Depending on the design or embodiment example of the insulating insert, it may be advantageous to align the undercut axially (i.e. parallel to the longitudinal axis of the insulating insert) or to align the undercut radially (i.e. along the circumference). As an alternative to the undercut, the distal region of the insulating insert may also have a hole or a notch or other depression in which the flexible component can be stuck.
[0015] Finally, it is also conceivable that the sheath surface of at least the distal portion of the flexible component and the insulating insert forms a continuous surface. Such a continuous surface design can prevent the insulating insert from being caught in the urethra or making it difficult to fully reprocess the insulating insert for reuse.
[0016] A handheld surgical instrument for solving the above-mentioned tasks has been provided. In particular, the handheld surgical instrument may be an electrosurgeon or the like. The handheld surgical instrument claimed for protection has 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 present invention, an insulating insert according to the present disclosure is detachably associated with the distal end of the inner shaft. By such an arrangement in which the insulating insert is located at the distal ends of both the inner shaft and the outer shaft, it is possible to prevent an electrosurgical tool or electrode led out of the insulating insert through the inner shaft from electrically contacting the shaft tube formed of metal. BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The preferred embodiments of the present invention are described in more detail below in conjunction with the accompanying drawings.
[0018] Figure 1 is a schematic representation of a hand-held surgical instrument, in particular, a resectoscope,
[0019] Figure 2 is a perspective view of an insulating insert,
[0020] Figure 3 is based on Figure 2 A cross-sectional view of an insulating insert,
[0021] Figure 4 is a perspective view of another embodiment of an insulating insert,
[0022] Figure 5 is based on Figure 4 A cross-sectional view of an insulating insert,
[0023] Figure 6 is a perspective view of another embodiment of an insulating insert,
[0024] Figure 7 is based on Figure 6 A cross-sectional view of the insulating insert, and
[0025] Figure 8 is a cross-sectional view through the distal end region of the insulating insert.
[0026] List of reference symbols:
[0027] 10 Resectoscope
[0028] 11 Resectoscope axis
[0029] 12 External axis
[0030] 13 Inner shaft
[0031] 14 Electrode Devices
[0032] 15 Optics
[0033] 16 Electrodes
[0034] 17 Retaining element
[0035] 18 Handle
[0036] 19 Sliders
[0037] 20 handle part
[0038] 21 handle part
[0039] 22 Spring Bridge
[0040] 23 Insulation insert
[0041] 24 Proximal
[0042] 25 Far End
[0043] 26 Connecting device
[0044] 27 Zhoubu
[0045] 28 Flexible components
[0046] 29 Distal part
[0047] 30 Sheath area
[0048] 31 Undercut
[0049] 32 wall DETAILED DESCRIPTION
[0050] Figure 1 A schematic cross-sectional view of a resectoscope 10 is shown. It should be explicitly pointed out that this resectoscope 10 is shown only as one possible embodiment of the claimed handheld surgical instrument. Similarly, it is conceivable that the handheld surgical instrument is an instrument other than the resectoscope 10 shown herein.
[0051] The resectoscope 10 has a resectoscope shaft 11, which includes an outer shaft 12 or sheath shown. A tubular inner shaft 13 extends within the outer shaft 12, and an electrode instrument 14 and an indicator optical device 15 are shown within the inner shaft 13. In addition, other elements (such as a separate irrigation tube, etc.) not shown here can extend within the resectoscope 10.
[0052] The electrode instrument 14 has an electrosurgical tool or electrode 16 at the distal end. The electrode 16 shown here is shown as a ring, but can also be formed as a button, etc. Figure 1 In the figure, it can be seen that the electrode instrument 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 partially circular cross section. The electrode instrument 14 is longitudinally displaceably mounted in 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 optic 15 and has a partially cylindrical shape.
[0053] By actuating the handle 18, the electrode instrument 14 can be forcibly moved axially in the distal and proximal directions. In this way, it can be pushed beyond the distal ends of the inner shaft 13 and the outer shaft 12. This allows the surgeon to manipulate tissue further away from the end of the resectoscope. In addition, for this purpose, the inner shaft 13 and / or the electrode instrument 14 can be rotatably mounted around its longitudinal axis. In order to manipulate the tissue, a high-frequency current is applied to the electrode 16.
[0054] Figure 1 The resectoscope 10 shown has a passive transmitter, in which the slider 19 is displaced in the distal direction of the first handle portion 21 against the distal end by the relative movement of the handle portions 20 and 21 arranged proximally on the resectoscope shaft 11 against the spring force applied by the spring bridge 22. When the slider 19 is displaced in the distal direction against the handle portion 21, the electrode instrument 14 is displaced in the distal direction in a manner not shown. When the load is released from the handle portions 20, 21, the spring force generated by the spring bridge 22 forces the slider 19 to return to its initial position, pulling the electrode instrument 14 in the proximal direction. When the slider 19 is moved back, electrosurgery can be performed with the electrode 16 without the operator's manual force, that is, passively.
[0055] The insulating insert 23 is releasably coupled at its proximal end 24 to the distal end 25 of the inner shaft 13 (see, e.g., Figure 2 , only the distal region of the device is shown here). For this purpose, the insulating insert 23 has a coupling device 26 at its proximal end 24. To treat the patient, the resectoscope 10 is pushed into the patient's urethra with the insulating insert 23 in front. In order to prevent the above-mentioned trauma to the urethra or mucosa, the circumference 27 of the insulating insert 23 has a flexible component 28. This flexible component 28 can be associated with the circumference 27 of the distal region 29 of the insulating insert 23, as described according to Figure 2 and Figure 3 As shown in the example of embodiment shown. Thus, in the example of embodiment shown, the flexible component 28 can be regarded as a kind of ring. According to the present invention, this flexible component 28 is made of silicone, elastomer or other flexible material. If during the insertion of the resectoscope 10, the insulating insert 23 with the flexible component 28 in front encounters the mucosa, no injury or trauma is caused, but the elastic deformation of the flexible component 28. Therefore, the mucosa will not be deformed and ultimately cause injury due to the transmitted mechanical stress. The insulating insert 23 is made of a rigid material such as ceramic, composite, plastic, etc., so the shape of the insulating insert 23 itself will not change and will not interfere with the function of the resectoscope 10.
[0056] exist Figure 2 and Figure 3In the example embodiment shown, the entire distal region 29 of the insulating insert 23 is surrounded by the flexible component 28, so that the mucosa of the urethra is protected regardless of the contact area of the insulating insert 23.
[0057] Alternatively, it is also conceivable that only a portion of the distal region 29 of the insulating insert 23 has the flexible component 28. For example, Figure 4 and Figure 5 An embodiment is illustrated in which only the upper region of the periphery or periphery 27 is provided with a flexible component 28. It can be seen that the flexible component 28 extends on the inner side, the front side and the outer side of the distal portion 29. Thus, the upper region of the periphery 27 is at least partially surrounded by the flexible component 28.
[0058] Figure 6 and Figure 7 An embodiment is shown in which this encirclement of the upper part of the periphery 27 is more pronounced. Here, the flexible component 28 extends in the direction of the proximal end 24 on the upper side or side or sheath region 30 of the insulating insert 23. Due to this enlargement of the flexible component 28, greater forces applied from the outside to the insulating insert 23 or the mucosa can be absorbed.
[0059] According to the invention, the width of the flexible component 28 is 0.3 mm to 7.0 mm, preferably 0.5 mm to 2.0 mm. In this case, the component 28 is dimensioned so that it is in the same plane as the sheath region 30 of the insulating insert 23, so that there is no constriction between the outer shaft 12 and the inner shaft 13.
[0060] In order to achieve a particularly stable and secure connection between the flexible component 28 and the peripheral portion 27 of the insulating insert 23, it can be provided that the peripheral portion 27 has an undercut 31. Figure 8 As shown, the periphery 27 of the distal portion 29 may be associated with a radial undercut 31 having a rectangular parallelepiped cross section. This undercut 31 confers additional mechanical resistance to the flexible component 28, for example, injection-molded around the distal region 29, and protects against undesired detachment of the flexible component 28 from the insulating insert 23 when external forces are applied. Figure 8 , only a cross-section of the wall 32 of the insulating insert 23 is shown. Alternatively or additionally, it is also conceivable that the distal region or portion 29 is associated with an axial undercut or several smaller radial undercuts in order to further increase the stability of the connection between the flexible component 28 and the insulating insert 23.
Claims
1. An insulating insert (23) for a handheld surgical instrument, in particular for a resectoscope (10), the tubular insulating insert (23) having a coupling device (26) at a proximal end (24) for releasably coupling to a distal end (25) of a tubular inner shaft (13) of the handheld surgical instrument, characterized in that The tubular insulating insert (23) has at least one flexible component (28) at its circumference (27).
2. The insulating insert (23) according to claim 1, characterized in that The at least one flexible component (28) is arranged at the periphery (27) of the distal portion (29) of the insulating insert (23).
3. The insulating insert (23) according to claim 1 or 2, characterized in that The flexible component (28) is made of silicone or elastomer and / or the insulating insert (23) is made of a rigid material, in particular ceramic or plastic.
4. The insulating insert (23) according to claim 2, characterized in that The flexible member (28) extends annularly around the entire circumference (27) of the distal portion (29).
5. The insulating insert (23) according to any one of the preceding claims, characterized in that The hardness of the flexible component (28) is 10 Shore A to 90 Shore A, preferably 30 Shore A to 70 Shore A.
6. The insulating insert (23) according to claim 2, characterized in that The flexible component (28) extends over the entire circumference (27) of the distal portion (29) within an angular range of 45° to 180°, in particular within an angular range of 90°.
7. The insulating insert (23) according to claim 2, characterized in that The flexible component (28) is arranged at a portion of the peripheral portion (27) of the distal portion (29) that extends farthest in the distal direction.
8. The insulating insert (23) according to claim 2, characterized in that The flexible component (28) is arranged on the outer side or upper side and / or inner side and / or end side of the distal portion (29), and / or the flexible component (28) extends on the outer side toward the proximal end (24).
9. The insulating insert (23) according to any one of the preceding claims, characterized in that Two, three or more flexible components (28) are arranged on the periphery (27).
10. The insulating insert (23) according to any one of the preceding claims, characterized in that The flexible component (28) has a length of 0.3 mm to 7.0 mm in the axial direction, preferably, a length of 0.5 mm to 2.0 mm.
11. The insulating insert (23) according to claim 2, characterized in that The distal end portion (29) of the insulating insert (23) has an axial and / or radial or annular undercut (31) for improving the adhesion of the flexible component (28).
12. The insulating insert (23) according to claim 2, characterized in that At least the sheath region (30) of the distal portion (29) of the insulating insert (23) forms a continuous surface with the flexible component (28).
13. A handheld surgical instrument, in particular a resectoscope (10), comprising an inner shaft (13) or shaft tube and an outer shaft (12) or sheath tube, and an insulating insert (23) according to claim 1, wherein: The insulating insert (23) is releasably coupled to the inner shaft (13), and the outer shaft (12) is movable on the inner shaft (13) and the insulating insert (23).