Ultrasonic surgical instruments with shock-absorbing coating

Abstract

This invention provides an ultrasonic surgical instrument with a shock-absorbing coating. The instrument includes an amplitude transformer with a coating on its outer surface. This coating includes a shock-absorbing layer with a thickness greater than 0.0001 mm. The coating reduces the ineffective radial amplitude at the front end of the amplitude transformer, effectively addressing technical problems such as amplitude transformer overheating, poor hemostasis, and fracture failure when cutting hard tissue. It also reduces adhesion between tissue and the amplitude transformer. The added shock-absorbing coating structure between the front end of the amplitude transformer and the hard tissue provides a buffering and shock-absorbing effect, preventing the front end of the amplitude transformer from flexing and deforming, stabilizing the amplitude transformer's vibration mode, reducing the generation of ineffective vibration energy, and preventing amplitude transformer fracture failure.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and further to ultrasonic surgical instruments, particularly to ultrasonic surgical instruments with shock-absorbing coatings. Background Technology

[0002] In the field of energy surgery for medical devices, specifically, it is an ultrasonic surgical cutting instrument, hereinafter referred to as ultrasonic scalpel. The main functional part of the ultrasonic scalpel is the amplitude transformer, which mainly includes a front bend, a middle gain structure, and a tail connection structure.

[0003] The key to current ultrasonic scalpel technology is the amplitude transformer. It utilizes the thermal, cavitation, and mechanical vibrations generated by the high-frequency vibrations at the front end of the transformer to cut and coagulate biological tissue at a relatively low temperature. However, when the amplitude transformer transmits ultrasound waves, only the waveform energy propagating longitudinally along the transformer's axis is needed; the waveform energy propagating radially along the cross-section is useless. These two types of wave energy are generally characterized by effective axial amplitude and ineffective radial amplitude. Figure 1-1 As shown. In existing technologies, most ultrasonic scalpels have a non-axisymmetric front-end structure. While this improves the surgeon's ease of operation and field of vision, this non-axisymmetric structure exacerbates the increase in ineffective radial amplitude. This ineffective energy causes severe internal friction within the amplitude transformer grains, macroscopically manifesting as internal heat accumulation, leading to severe overheating at the amplitude transformer tip. Furthermore, the hemostatic effect of the ultrasonic scalpel relies primarily on the "cavitation effect" generated by the longitudinal vibration of the amplitude transformer; ineffective radial vibration weakens the hemostatic ability of the ultrasonic scalpel. In addition, when the ultrasonic scalpel tip clamps relatively hard tissue, although multiple springs at the tail of the amplitude transformer act as buffers to apply a step-by-step closing force, the tip of the amplitude transformer still flexes and deforms, altering the vibration mode and further exacerbating the generation of ineffective vibration energy, even leading to amplitude transformer breakage and failure. Therefore, there is a need to propose an ultrasonic surgical instrument with a new amplitude transformer to solve the above-mentioned technical problems. Summary of the Invention

[0004] This invention provides an ultrasonic surgical instrument with a shock-absorbing coating. A shock-absorbing coating is added to the front end of the amplitude transformer. This coating can effectively reduce the ineffective radial amplitude at the front end of the amplitude transformer, thereby solving at least the technical problems of amplitude transformer overheating, poor hemostasis, and amplitude transformer breakage failure when cutting hard tissue in the prior art.

[0005] The present invention provides an ultrasonic surgical instrument with a shock-absorbing coating. The ultrasonic surgical instrument includes an amplitude transformer. The outer surface of the amplitude transformer is provided with a coating, which includes a shock-absorbing coating. The thickness of the coating is greater than 0.0001 mm. The coating reduces the ineffective radial amplitude at the front end of the amplitude transformer.

[0006] Optionally, the aforementioned amplitude transformer includes a front elbow, and the aforementioned damping coating is located on the outer surface of the aforementioned front elbow.

[0007] Optionally, the coating includes an undercoat and a damping coating, wherein the undercoat is located on the outer surface of the amplitude transformer and the damping coating is located on the outer surface of the undercoat.

[0008] Optionally, the coating may further include a low-friction coefficient layer located on the outer surface of the damping coating.

[0009] Optionally, the material of the above-mentioned shock-absorbing coating includes polytetrafluoroethylene.

[0010] Optionally, the thickness of the above-mentioned damping coating satisfies the following relationship: 0.0005mm ≤ thickness ≤ 0.01mm.

[0011] Optionally, the thickness of the above-mentioned damping coating satisfies the following relationship: 0.001mm ≤ thickness ≤ 0.005mm.

[0012] Optionally, the aforementioned base coating is applied to the front end of the outer surface of the aforementioned amplitude transformer using thermal spraying, anodizing, or chemical vapor deposition processes.

[0013] Optionally, the material of the above coating includes a polymer.

[0014] Optionally, the material of the coating may include metal oxides or small molecule organic compounds.

[0015] To address the aforementioned shortcomings in the prior art, this invention provides an ultrasonic surgical instrument with a shock-absorbing coating, which reduces the ineffective radial amplitude at the front end of the amplitude transformer, stabilizes and improves the technical problems of amplitude transformer overheating, poor hemostasis, and amplitude transformer breakage failure when cutting hard tissue, and reduces adhesion between tissue and amplitude transformer.

[0016] A damping coating structure is added between the front end of the amplitude bar and the rigid structure, which has a buffering and damping effect, so that the front end of the amplitude bar no longer flexes and deforms, the vibration mode of the amplitude bar is stable, thereby reducing the generation of ineffective vibration energy and preventing the amplitude bar from breaking and failing. Attached Figure Description

[0017] The above and other objects, features, and advantages of exemplary embodiments of the present invention will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings. Several embodiments of the invention are illustrated in the drawings by way of example and not limitation, wherein:

[0018] Figure 1 A schematic diagram of an optional ultrasonic surgical instrument with a shock-absorbing coating provided for an embodiment of the present invention;

[0019] Figure 1-1A comparison diagram of optional effective axial amplitude and ineffective radial amplitude provided for existing technologies;

[0020] Figure 2 A schematic diagram of an optional amplitude transformer B provided for an embodiment of the present invention;

[0021] Figure 3-1 A schematic diagram of the cross-sectional cut-off position of the above-mentioned amplitude rod B with a damping coating, provided for an embodiment of the present invention;

[0022] Figure 3-2 for Figure 3-1 A schematic cross-sectional view of an optional AA cross section with a damping coating;

[0023] Figure 3-3 for Figure 3-1 A schematic cross-sectional view of an optional AA cross section with a damping coating and an undercoat;

[0024] Figure 3-4 for Figure 3-1 A schematic cross-sectional view of an optional AA cross section having a damping coating, an undercoat, and a low-friction coefficient layer.

[0025] Figure label:

[0026] Ultrasonic scalpel A, amplitude transformer B, coating area BT, front bend 1, intermediate gain structure 2, tail connection structure 3, amplitude transformer cross section B1, vibration damping coating cross section B2, bottom coating cross section B3, low friction coefficient layer cross section B4. Detailed Implementation

[0027] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numbers in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present invention. Rather, they are merely examples of apparatuses and methods consistent with some aspects of the invention as detailed in the appended claims.

[0028] like Figure 1 As shown, this embodiment of the invention provides an ultrasonic surgical instrument with a shock-absorbing coating. The main functional part of the ultrasonic surgical instrument, namely the ultrasonic scalpel A, is the amplitude transformer B, as shown... Figure 2 As shown, the aforementioned amplitude transformer B mainly includes a front elbow 1, an intermediate gain structure 2, and a tail connection structure 3. The outer surface of the aforementioned amplitude transformer B is coated, such as... Figure 1As shown, the coating area BT is disposed on the outer surface of the aforementioned amplitude transformer B. Further, the coating area BT can be disposed on the outer surface of the aforementioned front elbow 1. The thickness of the coating is greater than 0.0001 mm; for example, the thickness of the coating can be 0.005 mm or 0.001 mm. Figure 3-1 This is a schematic diagram of the cross-sectional cutoff position AA of the aforementioned amplitude transformer B with a damping coating. Technical solution 1 is... Figure 3-2 The proposed solution Figure 3-2 for Figure 3-1 A schematic cross-sectional view of an optional cross-section with a damping coating, i.e., as shown in the diagram. Figure 3-1 and Figure 3-2 As shown, a damping coating is provided on the outer surface of the aforementioned amplitude transformer B. Specifically, the damping coating's cross-section B2 is located outside the amplitude transformer cross-section B1. This damping coating reduces the ineffective radial amplitude at the front end of the amplitude transformer B, thereby providing shock absorption and protecting the ultrasonic scalpel head. The damping coating can be made of, but is not limited to, rubber, tetrafluoroethylene, or polytetrafluoroethylene, and can also be other polymers or metal oxides. Optionally, the damping coating can be located at the front end of the amplitude transformer for better results, as the ineffective radial amplitude is greatest at the front end. Therefore, placing the damping coating at the front end of the amplitude transformer achieves a good effect and saves material, thereby reducing amplitude transformer heating, improving hemostasis, and reducing the likelihood of amplitude transformer breakage when cutting hard tissue. Adding a damping coating to the front end of the ultrasonic scalpel amplitude transformer reduces the ineffective radial amplitude at the front end.

[0029] Furthermore, technical solution 2 is... Figure 3-3 The illustrated scheme includes an undercoat and a damping coating. The undercoat is located on the outer surface of the amplitude transformer B, and the damping coating is located on the outer surface of the undercoat. Figure 3-3 As shown, the cross-section B3 of the bottom coating is located on the outer surface of the cross-section B1 of the amplitude transformer, and the cross-section B2 of the damping coating is located on the outer surface of the cross-section B3 of the bottom coating.

[0030] To address the issue of adding a coating to the front end of the ultrasonic scalpel's amplitude transformer, a base coat and a damping coating are added. The base coat can generally be made of materials such as, but is not limited to, fluorinated ethylene-propylene copolymers, and is applied to the front end of the amplitude transformer using processes not limited to thermal spraying, anodizing, and chemical vapor deposition. The purpose is to increase the adhesion between the damping coating and the substrate. The damping coating can generally be made of, but is not limited to, rubber, tetrafluoroethylene, polytetrafluoroethylene, metal oxides, and polymers. Its thickness is greater than 0.0001 mm, which helps to reduce the ineffective radial amplitude at the front end of the amplitude transformer, thereby stabilizing and improving the amplitude transformer's ability to heat up, its poor hemostasis, and its failure when cutting hard tissue.

[0031] Furthermore, technical solution 3 is... Figure 3-4 The illustrated scheme further includes a low-friction coefficient layer, which is located on the outer surface of the damping coating, such as... Figure 3-4 As shown, the cross-section B3 of the aforementioned base coating is located on the outer surface of the cross-section B1 of the aforementioned amplitude transformer, the cross-section B2 of the aforementioned damping coating is located on the outer surface of the cross-section B3 of the aforementioned base coating, and the cross-section B4 of the aforementioned low-friction coefficient layer is located on the outer surface of the cross-section B2 of the aforementioned damping coating. A coating is added to the front end of the ultrasonic scalpel amplitude transformer, including a base coating, a damping coating, and a low-friction coefficient layer. The base coating can generally be made of materials such as, but is not limited to, fluorinated ethylene propylene copolymer, and is applied to the front end of the amplitude transformer using processes not limited to, thermal spraying, anodizing, and chemical vapor deposition, with the aim of increasing the adhesion between the damping coating and the substrate. The damping coating can generally be made of, but is not limited to, rubber, tetrafluoroethylene, polytetrafluoroethylene, metal oxides, and polymers. Its thickness is greater than 0.0001 mm, enabling it to reduce the ineffective radial amplitude at the front end of the amplitude transformer, thereby stabilizing and improving the amplitude transformer's ability to heat up, its poor hemostasis effect, and its failure when cutting hard tissue. The low-friction coefficient layer can be made of materials such as rubber, tetrafluoroethylene, polytetrafluoroethylene, metal oxides, and polymers, and its purpose is to reduce the adhesion between biological tissue and the amplitude rod.

[0032] Furthermore, the material of the aforementioned undercoat includes fluorinated ethylene propylene copolymer.

[0033] Furthermore, the aforementioned base coating is applied to the front end of the outer surface of the aforementioned amplitude transformer using thermal spraying, anodizing, or chemical vapor deposition processes.

[0034] Furthermore, the material of the above coating includes high molecular polymers.

[0035] Furthermore, the aforementioned polymers include rubber or polytetrafluoroethylene.

[0036] Furthermore, the materials used in the coating include metal oxides or small molecule organic compounds.

[0037] The above technical solution is a solution with unexpected technical effects obtained through a large number of uncertain and repeated experiments. The experimental records directly related to the technical solution of this invention are as follows:

[0038] Test 1. Test for presence / number of coatings

[0039] Experimental procedure instructions:

[0040] Prepare four sets of prototypes, 10 in each set. The control group consists of a conventional amplitude transformer without any coating (existing technology), and the test group consists of technical solution 1 (…). Figure 3-2 Scheme 1 and Scheme 2 are shown. Figure 3-3 The scheme shown) and technical scheme 3 ( Figure 3-4 (Scheme shown).

[0041] After the amplitude transformer operates under standard load for 10 minutes, the ineffective radial amplitude and temperature at the front end of the amplitude transformer are measured using a laser vibrometer. This is to compare the effect of having or not having a coating on the ineffective radial amplitude and ineffective thermal energy.

[0042] The results are shown in the table below:

[0043]

[0044]

[0045] Experimental Conclusion: Based on the principle that the lower the ineffective radial amplitude and the lower the operating temperature, the better, the above experiments show that technical solutions 1, 2, and 3 all have significant and unexpected effects compared to existing technologies. In particular, technical solution 3 has the lowest ineffective radial amplitude and operating temperature, and its effect is the most significant. That is, as long as a damping coating is provided, it already has a significant and unexpected technical effect compared to existing technologies. Technical solutions 2 and 3 have added improvements to technical solution 1, and achieved further unexpected technical effects.

[0046] Experiment 2. Vibration damping coating materials

[0047] Experimental procedure instructions:

[0048] Three sets of prototypes were prepared for the "damping coating" of the basic scheme 1 in Experiment 1, using three different materials, with 10 prototypes in each set. After the amplitude transformer worked for 10 minutes under standard load, the ineffective radial amplitude and temperature at the front end of the amplitude transformer were measured with a laser vibration meter. This was to compare the effects of different materials on ineffective radial amplitude and ineffective thermal energy.

[0049] The results are shown below:

[0050]

[0051]

[0052] Experimental conclusions: Based on the principles that the lower the ineffective radial amplitude and the lower the operating temperature, the better, the above experiments show that different materials have different effects on ineffective radial amplitude and ineffective thermal energy, among which polytetrafluoroethylene (PTFE) has the best effect.

[0053] Experiment 3. Different coating thicknesses

[0054] Experimental procedure instructions:

[0055] Four prototypes were prepared for the thickness of the "damping coating" in the basic scheme 1 of Experiment 1. Under the premise of using polytetrafluoroethylene (PTFE) as the coating, four different thickness values ​​were used, with 10 prototypes in each group. After the amplitude transformer worked for 10 minutes under standard load, the ineffective radial amplitude and temperature at the front end of the amplitude transformer were measured with a laser vibration meter. This was to compare the effects of different thicknesses of the same material on the ineffective radial amplitude and ineffective thermal energy.

[0056] The results are shown below:

[0057]

[0058]

[0059] Experimental conclusions: Based on the principles that the lower the ineffective radial amplitude and the lower the operating temperature, the better, the above experiments show that different thicknesses of the same material have different effects on ineffective radial amplitude and ineffective thermal energy. It is not necessarily true that the thicker or thinner the material, the better. A thickness of 0.0001 mm has a certain effect, and a thickness between 0.0005 mm and 0.01 mm has a more significant effect, with the most significant effect observed in the thickness between 0.001 mm and 0.005 mm.

[0060] It should be noted that although several units / modules or sub-units / modules of the device have been mentioned in the detailed description above, this division is merely exemplary and not mandatory. In fact, according to embodiments of the present invention, the features and functions of two or more units / modules described above can be embodied in one unit / module. Conversely, the features and functions of one unit / module described above can be further divided and embodied by multiple units / modules.

[0061] Furthermore, although the operations of the method of the present invention are described in a specific order in the accompanying drawings, this does not require or imply that these operations must be performed in that specific order, or that all the operations shown must be performed to achieve the desired result. Additionally or alternatively, certain steps may be omitted, multiple steps may be combined into one step, and / or one step may be broken down into multiple steps.

[0062] While the spirit and principles of the invention have been described with reference to several specific embodiments, it should be understood that the invention is not limited to the disclosed specific embodiments, and the division of aspects does not imply that features in these aspects cannot be combined for benefit; such division is merely for ease of description. The invention is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

Claims

1. An ultrasonic surgical instrument with a shock-absorbing coating, the ultrasonic surgical instrument comprising an amplitude transformer, characterized in that, The outer surface of the amplitude transformer is provided with a coating, the coating including a damping coating, the thickness of the coating being greater than 0.0001 mm, the coating reducing the ineffective radial amplitude at the front end of the amplitude transformer; The amplitude transformer includes a front elbow, and the damping coating is located on the outer surface of the front elbow; The coating includes an undercoat and a damping coating. The undercoat is located on the outer surface of the amplitude transformer, and the damping coating is located on the outer surface of the undercoat. The coating also includes a low-friction coefficient layer, which is located on the outer surface of the damping coating; The material of the damping coating includes polytetrafluoroethylene; The thickness of the damping coating satisfies the following relationship: 0.001mm ≤ thickness ≤ 0.005mm.

2. The ultrasonic surgical instrument according to claim 1, characterized in that, The underlying coating is applied to the front end of the outer surface of the amplitude transformer using thermal spraying, anodizing, or chemical vapor deposition processes.

3. The ultrasonic surgical instrument according to claim 1 or claim 2, characterized in that, The coating material includes high molecular polymers.

4. The ultrasonic surgical instrument according to claim 1, characterized in that, The coating material includes metal oxides or small molecule organic compounds.

Images