Arbor with vibration isolation support members, method of making and use thereof

Abstract

The application discloses a cutter bar with a vibration isolation supporting part and a manufacturing method and application thereof. The cutter bar with the vibration isolation supporting part has a cutter bar body, the cutter bar is installed in an inner sleeve, the surface of the cutter bar is covered with the vibration isolation supporting part, the vibration isolation supporting part is located between the cutter bar and the inner sleeve when the cutter bar is installed in the inner sleeve, and the vibration isolation supporting part is graphene aerogel. The manufacturing method of the cutter bar with the vibration isolation supporting part comprises the following steps: pretreating the cutter bar and preparing graphene aerogel; placing the cutter bar in a mold, injecting the graphene aerogel to coat the surface of the cutter bar with the graphene aerogel, and finally performing demolding treatment. The cutter bar with the vibration isolation supporting part is used for manufacturing an ultrasonic knife. The cutter bar with the vibration isolation supporting part has the advantages of good flexibility, high compression deformation performance, high fatigue resistance, reduced ultrasonic wave attenuation, good cutter bar supporting effect, reduced blood and tissue adhesion, convenient secondary cleaning, met complex cleaning requirements, and reduced use cost of patients.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a knife rod with vibration isolation support components and a manufacturing method and application thereof. BACKGROUND

[0002] The existing ultrasonic surgical cutting hemostatic instrument; the ultrasonic mechanical energy needs to be transmitted to the execution part through the ultrasonic knife rod embedded in the inner tube. The ultrasonic wave propagates along the longitudinal sine wave of the ultrasonic knife rod. In the transmission process of the ultrasonic wave, in addition to the longitudinal wave, there are surface wave, transverse wave and torsional wave, which leads to the attenuation of the ultrasonic mechanical energy. Because the knife rod is long and is subjected to radial bending, a number of supports need to be arranged along the axial direction. These supports should reduce the loss of ultrasonic energy propagation.

[0003] In order to ensure the stability of the transmission energy, the existing ultrasonic surgical knife is provided with a rubber coating on the outer side of the knife rod in the circumferential direction. The rubber coating reduces the vibration friction between the knife rod and the sleeve assembly, and avoids energy loss. Figure 9 As shown in the figure, because the knife rod has related parts in direct contact, Figure 10 The four positions marked in the figure are relatively difficult to achieve effective sterilization, which are: the shock-absorbing sleeve covering the knife rod; the inner sleeve covering the knife rod; the outer sleeve covering the inner sleeve; and the forceps head. In addition, the rubber coating on the knife rod is easy to damage and fall off during the cleaning process, which makes it impossible to be used repeatedly.

[0004] The rubber coating is usually a support assembly arranged between the inner tube and the ultrasonic knife rod to reduce the attenuation of ultrasonic vibration and ensure sufficient ultrasonic mechanical energy propagation to the execution site. However, in order to reduce the ultrasonic impedance, the support assembly is usually soft and has poor support stiffness, especially the support at the distal end of the ultrasonic waveguide, which has basically the same stiffness as the rest of the supports. Due to the particularity of the position of the support at the distal end of the ultrasonic waveguide, i.e. the outermost end of the support assembly, insufficient support stiffness easily leads to unstable support, thereby affecting the propagation of ultrasonic mechanical energy. Obviously, the structure design of the distal end support of the ultrasonic waveguide in the prior art is not reasonable. On the other hand, since the distal end of the ultrasonic waveguide is adjacent to the execution site, blood, body fluid and the like need to be prevented from entering the inner tube during operation. Therefore, the sealing performance of the distal end support of the ultrasonic waveguide is required to be high, however, the structure design of the support in the prior art is not reasonable, the sealing performance is not high enough, and it is difficult to achieve sufficient sealing effect, and blood, body fluid and the like may still flow into the inner tube during actual use.

[0005] In the prior art, the position design of the ultrasonic knife rod node is not reasonable, the constraint stiffness of the node is too high or too soft, which easily causes the attenuation of the ultrasonic wave; and the commonly used node support material is silica gel, which is sensitive to high temperature and may fall off after repeated use; and the support provided is blunt, which leads to inconsistent pressure distribution.

[0006] The ultrasonic vibrations can be accompanied by a thermal effect. This thermal effect can also increase as the surgical material dries out and adheres to the surface of the end effector. This thermal effect can cause the end effector to perform less well, for example, the ability to vibrate can be reduced, or the useful life can be shortened, or even cause an accident during the surgical procedure.

[0007] To compensate for the increase in impedance, the generator will continually increase the energy to the end effector to complete the transection until the energy exceeds a set safety threshold, at which point the generator will alarm and enter a "locked out" state. Lockout is the phenomenon where the impedance of the end effector is too high for the generator to output an effective power to the front end to clamp tissue. Generator lockout is an undesirable result that occurs when the interface impedance increases to the point where the generator cannot provide enough power to the end effector to complete transection. When the generator enters a "locked out" state, the surgical procedure is interrupted. Thus, generator "lockout" results in increased cutting and transection times, or worse, a failure during the surgical procedure. Therefore, there is a need for a suitable support and sealing feature that can protect the end effector in harsh surgical environments.

[0008] The current common practice is to prevent the accumulation of surgical material by adding a special coating to the surface of the end effector. This coating can absorb moisture and prevent them from interacting with the surface of the end effector. In addition, researchers can also design a new surgical material that can keep its wet state by absorbing moisture, so that they can prevent them from interacting with the surface of the end effector. However, these methods are not completely effective. If there are too many water molecules in the surgical material, they can cause excessive thermal effects with the surface of the end effector, resulting in reduced performance. Therefore, researchers need to further study how to effectively maintain the contact between the end effector and the surgical material to improve the effectiveness of ultrasonic vibration surgery. Suitable support and sealing can effectively inhibit or minimize the accumulation of surgical material on the outer surface of the end effector, minimize the generator lockout state, minimize power consumption, and improve the thermal properties of the end effector.

[0009] Ultrasound surgical instruments can be divided into two groups according to the type of end effector: single-element end effector instruments and multi-element end effector instruments. Single-element end effector instruments include surgical knives and ball coagulators; multi-element end effector instruments, where the cutting hemostatic knife has a scissors-type knife rod, which is usually divided into two types according to the working length; a gun-type knife rod, which is usually divided into four types according to the length, taking the 14-specification knife rod as an example; as shown in Figure 11 、 12

[0010] ​The figure of the mode of vibration when the 14-type blade bar resonates, wherein the middle dotted horizontal axis is the zero displacement reference line, the I-IV four node positions on the axial amplitude curve intersect with the zero displacement reference line, and there are points with zero displacement trend in the plane of the four positions; the maximum amplitude occurs at the tip of the blade bar.

[0011] The resonance amplitude of any point on the blade bar can be expressed as the following sinusoidal curve:

[0012] Disp.=A·sin(ω·t)

[0013] Wherein: A is the zero-peak value of the amplitude, ω=2·π·f, f is the resonance frequency, and t is the instantaneous time of vibration.

[0014] During the process of clamping the tissue, the blade bar bears the axial bending moment, therefore, elastic support needs to be provided between the node and the inner sleeve to reduce the attenuation during the ultrasonic transmission and ensure that the front end support can also play a sealing role.

[0015] Encapsulation position diagram Figure 9 There are four common 14-type blade bar encapsulation positions in the above diagram, corresponding to the four zero displacement positions in Figure 1 , the amplitude here is small, and the connection loss caused by encapsulation is minimal, which can isolate the contact friction between the blade bar and the inner sleeve.

[0016] Therefore, it can be considered that the encapsulation position is related to the node; however, batch differences such as machining, materials, and heat treatment can cause the node position to drift, and the conventional solution is to first perform a sample before each batch processing to relatively accurately locate the node position, which increases the cost waste and manufacturing difficulty. SUMMARY

[0017] The purpose of the present application is to provide a blade bar with a vibration isolation support component and a manufacturing method and application thereof, which can reduce ultrasonic wave attenuation and has good waveguide support effect, and can also effectively avoid the instrument failure caused by the backflow of tissue / blood blocking.

[0018] The present application is implemented by the following technical solutions: a blade bar with a vibration isolation support component, the main body of which is a blade bar, and the blade bar is installed in an inner sleeve; the surface of the blade bar is covered with a vibration isolation support component, so that when the blade bar is installed in the inner sleeve, the vibration isolation support component is located between the blade bar and the inner sleeve.

[0019] The vibration isolation support component is a graphene aerogel.

[0020] The manufacturing method of the blade bar with a vibration isolation support component,

[0021] It includes the following steps:

[0022] Step 1: tool bar pretreatment: the machined tool bar is polished with emery paper and then cleaned with deionized water and anhydrous ethanol under ultrasonic wave, and dried with nitrogen; then the surface morphology of the titanium alloy tool bar is observed, and the tool bar is qualified if the surface is smooth and free of obvious protrusions or scratches;

[0023] Step 2: prepare graphene aerogel as a support;

[0024] Step 3: after washing, the graphene aerogel prepared in step 2 is placed in a jig, and freeze-drying is performed to obtain a graphene aerogel primary product;

[0025] Step 4: the tool bar is placed in a mold, the graphene aerogel primary product obtained by freeze-drying in step 3 is injected into the mold containing the tool bar from the pouring port at the upper part of the mold; then the mold is placed in a tube furnace, protective gas is introduced, and heating is performed for 2-10 h, and then the mold is naturally cooled, and a composite of graphene aerogel and tool bar is obtained in the mold;

[0026] Step 5: open the mold, remove the composite in step 4 from the mold through the top pin or air hole provided at the bottom of the mold, and cut and remove the excess material to obtain a tool bar with a vibration isolation support component.

[0027] The tool bar with a vibration isolation support component is used in the manufacture of an ultrasonic knife, the tool bar with a vibration isolation support component is installed in an inner sleeve of the ultrasonic knife, and the vibration isolation support component is attached to the inner wall of the inner sleeve.

[0028] Compared with the prior art, the tool bar with a vibration isolation support component has the following advantages:

[0029] 1. The tool bar with a vibration isolation support component has good flexibility, high compression deformation performance, high fatigue resistance, can reduce ultrasonic wave attenuation and has good tool bar support effect, can reduce blood and tissue adhesion, is convenient for secondary cleaning, can meet the needs of complex cleaning, and can reduce the use cost of patients.

[0030] 2. The graphene aerogel adopts a regional coverage principle, directly covers all node positions and intersection points of zero displacement reference lines, and does not need to consider the problem of node position drift.

[0031] 2. Relative sealing installation can play a sealing role during high-temperature and high-pressure sterilization, and can prevent water vapor from entering the sleeve assembly.

[0032] 3. Low friction and low impedance can reduce energy loss, reduce peeling and failure caused by heating at the support position, reduce the probability of "lockout" of the main machine, and improve the use experience.

[0033] 4. The graphene aerogel is made of insulating elastic material, can also play an electrical insulation role, and can improve safety. BRIEF DESCRIPTION OF DRAWINGS

[0034] Figure 1 This is a schematic diagram of the structure of the present invention;

[0035] Figure 2 A schematic diagram of the structure for casting the vibration isolation support component of the tool holder;

[0036] Figure 3 This is a schematic diagram of the upper mold's sprue structure;

[0037] Figure 4 This is a schematic diagram of the ejector pin structure of the lower mold;

[0038] Figure 5 A schematic diagram of a vibration isolation support component with heat dissipation perforations;

[0039] Figure 6 A schematic diagram of a cross-section with a heat dissipation perforation; (a) is a rectangle, (b) is a trapezoid, and (c) is a sector.

[0040] Figure 7 This is a diagram showing the results of the contact angle hydrophilicity test.

[0041] Figure 8 This is a schematic diagram of a pull-out force (self-lubricating) test.

[0042] Figure 9 This is a graph showing the data from the pull-out force (self-lubricating) test.

[0043] Figure 10 A schematic diagram of a structure in a traditional knife holder where effective sterilization is difficult to achieve;

[0044] Figure 11 A schematic diagram of the axial amplitude curve of a 14-gauge tool holder;

[0045] Figure 12 for Figure 11 A schematic diagram of the adhesive coating at the four nodes.

[0046] Labeling explanation: 1. Tool holder, 2. Vibration isolation support component, 3. Upper mold, 31. Sprue, 4. Lower mold, 41. Ejector pin, 5. Heat dissipation cutout. Detailed Implementation

[0047] The present invention will now be described in detail with reference to the accompanying drawings:

[0048] like Figure 1 As shown: A tool bar with vibration isolation support component, the main body of which is tool bar 1, which is installed in an inner sleeve; the surface of the tool bar is covered with vibration isolation support component 2, so that when the tool bar is installed in the inner sleeve, the vibration isolation support component is located between the tool bar and the inner sleeve;

[0049] The vibration isolation support component is graphene aerogel.

[0050] The graphene aerogel has good flexibility, high compression deformation performance, high fatigue resistance, can reduce ultrasonic wave attenuation and has good waveguide support effect, and has the effect of reducing blood and tissue adhesion, facilitating secondary cleaning, meeting the needs of complex cleaning, and reducing the use cost of patients.

[0051] The knife bar resonates, and a plurality of node positions on the axial amplitude curve intersect with the zero displacement reference line to form intersection points; the start end of the vibration isolation support component is located at the node at the front end of the knife bar, and the end of the vibration isolation support component is located at the node at the rear end of the knife bar.

[0052] The bending deformation of the knife bar caused by multi-point stress (silica gel encapsulation) can cause excessively high initial impedance in the case of jaw clamping, causing the host to enter the locked state too early, affecting the operation experience.

[0053] The graphene aerogel adopts the area coverage principle and directly covers all the intersection points of the node positions and the zero displacement reference line, without considering the problem of node position drift.

[0054] Specifically, since the mass ratio of the graphene aerogel support is very small, the influence of the node position offset can be ignored. Figure 1 It can be seen that the influence of the node position offset can be ignored, and the positioning restriction of the support position caused by the machining process, tool wear and material consistency can also be removed.

[0055] According to the production measured data, the influence of the graphene aerogel support on the overall resonance frequency is small, and the static impedance is reduced by 12%, and the dynamic impedance is reduced by 8%.

[0056] As shown in the figure, the surface of the vibration isolation support component is provided with a plurality of heat dissipation hollows 5. Figure 6 The cross-sectional shape of the heat dissipation hollows 5 is rectangular, trapezoidal or sector-shaped.

[0057] Here, the thermal conductivity of air is 26.7 mW / (m·K), and the thermal conductivity of graphene aerogel in air is 18 mW / (m·K), so the embodiment of increasing the graphene aerogel support slot is added to improve the risk of heat dissipation; the cross-sectional shape of the slot is not limited; the number of slots is 1-10, preferably, 2 / 4 / 6 even numbers.

[0058] In addition, the end of the vibration isolation support component is twisted relative to the start end of the vibration isolation support component in the axial direction of the vibration isolation support component, and the twist angle is 5-80°.

[0059] The following detects the knife bar + graphene aerogel support composite:

[0060] First, the contact angle (hydrophilicity) test

[0061] The experimental results show that the contact angles of the silica gel and graphene with purified water and physiological saline are 96.1° and 68.1° respectively, and 98.6° and 59.2° respectively. Figure 7 .

[0062] Compared with the existing liquid silica gel material, the contact angle of the graphene aerogel material under physiological saline is reduced by 40%, and the contact angle under ultrapure water is reduced by 66%.

[0063] It can be seen that the prepared graphene aerogel support has stronger hydrophilicity than the silica gel material, and the interfacial free energy is also lower, which can reduce the adsorption and other interactions of the material to various components in the blood, and thus has good anticoagulation performance.

[0064] Pulling force (self-lubricating) test

[0065] The friction resistance is evaluated by pulling, and the same profiled block is used for the friction resistance test under positive pressure.

[0066] From Figure 8 , 9 , it can be seen that the conventional liquid silica gel encapsulation will affect the surface roughness of the knife bar, and will increase the resistance of the knife bar during clamping and cutting the tissue; the new encapsulation scheme can effectively reduce the influence of the support on the friction resistance, ensure the smooth work of the knife head, and reduce the heat accumulation of the knife bar caused by the resistance. Therefore, the advantages of the scheme described in the application are that the self-lubricating performance is better, there are no toxic decomposition products, the properties are stable, the surface energy is low, the self-cleaning performance is stronger, and the performance of the knife head is almost not affected.

[0067] In addition, the influence on the acoustic parameters is considered: the density of the graphene aerogel support is 0.16 mg / cm3, the elastic modulus is 1.2 MPa, and the Poisson's ratio is 0.16. These parameters also indirectly prove that the influence of the graphene aerogel on the impedance is small.

[0068] The manufacturing method of the knife bar with the vibration isolation support part includes the following steps:

[0069] Step 1: Knife bar pretreatment: polish the machined knife bar with emery paper and pass through cloth polishing, then ultrasonically clean with deionized water and anhydrous ethanol, and dry with nitrogen; then observe the surface morphology of the titanium alloy knife bar, and the surface is flat and has no obvious protrusions or scratches, which is qualified;

[0070] Step 2: Prepare graphene aerogel as a support;

[0071] Step 3: Put the graphene aerogel prepared in step 2 into a jig after washing with water, and freeze-dry to obtain a graphene aerogel primary product;

[0072] Step 4: Put the knife bar into the mold, and inject the graphene aerogel primary product obtained by freeze-drying in step 3 into the mold containing the knife bar from the pouring port at the upper part of the mold; then place the mold in a tube furnace, pass a protective gas, heat for 2-10 hours, and then naturally cool down, so that a graphene aerogel and knife bar composite is obtained in the mold;

[0073] Step 5: Open the mold, take out the composite in step 4 from the mold through the thimble or air hole provided at the bottom of the mold, and cut and remove the excess material to obtain the knife bar with a vibration isolation support component.

[0074] In step 1, the grit size of the emery paper is 700-1000 mesh.

[0075] Step 2: The graphene aerogel is prepared by using the existing technology, and the specific preparation process is as follows:

[0076] Process 1: Put the expanded graphite powder into a high-temperature oven and heat at 1050℃ for 20s;

[0077] Process 2: Under ice bath conditions, add 1g of the heat-treated expanded graphite to 23mL of 98% concentrated sulfuric acid solution.

[0078] Process 3: Slowly add 3g of potassium permanganate to the mixed solution under stirring conditions, and ensure that the solution temperature is below 20℃. After sufficient dispersion, continue to stir the mixed solution at 35℃ for 30min;

[0079] Process 4: Gradually add 46mL of deionized water and stand for 15min; further dilute with 140mL of deionized water and treat with 12.5mL of 30% hydrogen peroxide;

[0080] Process 5: Filter the mixture, repeatedly wash with 200ml of 10% hydrochloric acid to remove metal ions, and then wash with a large amount of deionized water until the filtrate is neutral;

[0081] Process 6: Add appropriate amounts of initiator (hydrogen peroxide), reducing agent (hydrazine hydrate) and surfactant (sodium dodecyl benzene sulfonate) to the solution prepared in process 5, stir, pour into a reaction kettle, seal and stand to obtain a graphene hydrogel.

[0082] The initiator is one or more of hydrogen peroxide, ammonium persulfate, potassium persulfate, sodium persulfate, alkyl hydroperoxide, dialkyl peroxide, peroxy ester, peroxy diacyl, peroxy dicarbonate, azobisisobutyronitrile; the reducing agent is one or more of hydrazine hydrate, ascorbic acid, lithium aluminum hydride, sodium borohydride; and the surfactant is one or more of sodium dodecyl benzene sulfonate and sodium octadecyl sulfate.

[0083] In step 4, the mold is divided into an upper mold 3 and a lower mold 4, both of which are provided with a cutter bar limiting groove for accommodating the cutter bar, and a filling area with a width and depth greater than those of the middle section of the cutter bar limiting groove is arranged at the middle section of the cutter bar for accommodating the graphene aerogel for covering the outer periphery of the cutter bar later.

[0084] The pouring gate 31 is located on the upper mold 3, and the ejector pin 41 or the air hole is located on the lower mold 4.

[0085] The cutter bar with the vibration isolation support part is applied to the manufacture of an ultrasonic knife, and is specifically applied to that the cutter bar with the vibration isolation support part is installed in an inner sleeve of the ultrasonic knife, and the vibration isolation support part is attached to the inner wall of the inner sleeve.

[0086] Compared with the conventional ultrasonic knife, the main difference of the present application lies in the material and the distribution position of the vibration isolation support part, the material mainly adopts graphene aerogel, and the distribution position mainly adopts a full distribution mode.

[0087] Finally, it should be noted that: the above only for the preferred embodiments of the present application, and not for limiting the present application, although the foregoing embodiments of the present application are described in detail, for those skilled in the art, it still can be modified, or part of the technical features of the equivalent replacement, within the spirit and principles of the present application, any modification, equivalent replacement, improvement, etc., should be included in the scope of protection of the present application.

Claims

1. A tool shank with a vibration isolation support member, the main body of which is a tool shank (1) which is mounted in an inner sleeve; characterized in that: The surface of the tool bar is covered with a vibration isolation support part (2), so that when the tool bar is mounted in the inner sleeve, the vibration isolation support part is located between the tool bar and the inner sleeve. The vibration isolation support part is graphene aerogel.

2. The knife bar with an isolation support component of claim 1, wherein: When the tool bar resonates, a plurality of node positions on the axial amplitude curve intersect with the zero displacement reference line to form intersection points; the initial end of the vibration isolation support part is located at the node at the front end of the tool bar, and the terminal end of the vibration isolation support part is located at the node at the rear end of the tool bar.

3. The knife bar with vibration isolation support components of claim 1, wherein: The surface of the vibration isolation support part is provided with a plurality of heat dissipation hollows (5).

4. The knife bar with vibration isolation support components of claim 1, wherein: The cross-sectional shape of the heat dissipation hollow is rectangular, trapezoidal or sectorial.

5. The manufacturing method of the tool bar with a vibration isolation support part according to claim 1, characterized in that: It comprises the following steps: Step 1: tool bar pretreatment: after the machined tool bar is polished with emery paper and is brushed, it is ultrasonically cleaned with deionized water and anhydrous ethanol, and is dried with nitrogen; then the surface morphology of the titanium alloy tool bar is observed, and the tool bar is qualified if the surface is smooth and has no obvious protrusions or scratches; Step 2: prepare graphene aerogel as a support part; Step 3: after the graphene aerogel prepared in step 2 is washed with water, it is placed in a jig, and is freeze-dried to obtain a graphene aerogel primary product; Step 4: the tool bar is placed in a mold, the graphene aerogel primary product obtained by freeze-drying in step 3 is injected into the mold containing the tool bar from a pouring port at the upper part of the mold; then the mold is placed in a tube furnace, a protective gas is introduced, and heating is performed for 2-10 hours, and then the mold is naturally cooled, and a composite of graphene aerogel and the tool bar is obtained in the mold; Step 5: open the mold, remove the composite in step 4 from the mold through a thimble or a gas hole provided at the bottom of the mold, and cut and remove the excess material to obtain the tool bar with a vibration isolation support part.

6. The method of manufacturing according to claim 5, wherein: The grit number of the emery paper in step 1 is 700-1000.

7. The method of claim 5, wherein: In step 4, the mold is divided into an upper mold (3) and a lower mold (4), and the upper mold and the lower mold are both provided with a tool bar limiting groove for accommodating the tool bar, and a filling area with a width and a depth greater than those of the middle section of the tool bar limiting groove is arranged at the middle section of the tool bar for accommodating the graphene aerogel coated on the outer periphery of the tool bar later.

8. The method of claim 5, wherein: The pouring port (31) is located in the upper mold, and the thimble (41) or the gas hole is located in the lower mold.

9. The use of the knife bar with vibration isolation support member of claim 1 in the manufacture of an ultrasonic knife, wherein, The tool bar with a vibration isolation support part is mounted in the inner sleeve of the ultrasonic knife, and the vibration isolation support part is attached to the inner wall of the inner sleeve.

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