Laser-applied marking of medical devices for improved ultrasound and radiological imaging

Abstract

The present invention relates to a method for producing markers with improved visibility that can be applied to a wide variety of materials with a very high degree of geometric variability and can be used in both radiological and ultrasonographic applications. According to the present invention, this is essentially achieved in that a novel marking is produced by a polyurethane coating embedded with a particle film having functional properties and a high particle density. Using a laser, only the targeted coating areas in selected areas are dried and chemically crosslinked. The unirradiated coating material is then washed away to form the exposed areas. In this way, markings can be produced in any geometric shape.

Description

[Technical field]

[0001] The present invention relates to a method for making a medical device having markings visible for imaging purposes.The present invention further relates to a medical device made by the method.

[0002] In vitro visualization of medical devices and implants for therapeutic and diagnostic purposes by ultrasound (US) and radiography is of great clinical importance.

[0003] For optimal placement near the desired site of action and to avoid complications, the medical device should be easily visualized in its entirety during application, until final location inspection.

[0004] The internal structures and / or objects within a patient are primarily visualized using radiological and ultrasonographic techniques.

[0005] In particular, the present invention relates to catheters, which are typically used for drainage, irrigation, administration of diagnostic or therapeutic agents, biopsy, or access to hollow organs, among other procedures, and which comprise a substrate primarily made of a polymeric material.

[0006] However, invasive catheter placement and inspection of their position has proven difficult because the plastic materials used have extremely poor ultrasound visibility (echogenicity) and X-ray visibility (radiographic contrast).Currently available commercially available catheters can only be reliably visualized by ultrasound to a depth of a few millimeters below the skin surface.

[0007] The limiting factors in identification are the differences in material constants (acoustic impedance and x-ray absorption coefficient) between the body tissue and the catheter, and the geometric dimensions of the catheter.

[0008] The present invention includes a method for making visibility enhancing markers that can be applied to a wide variety of materials with extremely high geometric variability and can be used for both radiological and ultrasound applications.

[0009] To radiologically detect the location of the catheter within the patient along its entire length, the catheter material or strips thereof are filled with a radiopaque substance such as barium sulfate. Radiopaque markers are commonly used to identify individual regions of the catheter, such as the distal end.

[0010] It is known to embody markers in the form of coatings, bands, or inlays. For example, rings of solid radiopaque metal are attached to the catheter tube. Solid metal bands are relatively inflexible compared to the catheter shaft material, resulting in localized stiffness and undesirable discontinuities in the catheter. Bending and / or torsional stresses can cause failure of the composite and thus loss of the marker. Furthermore, metal markers are relatively expensive to fabricate and difficult to reliably attach to the underlying device.

[0011] Many of the problems associated with the use of metallic markers are overcome by replacing the rigid precious metal tube with a polymer that is filled or doped with a suitable radiopaque material.

[0012] As described in US6540721 and WO2005 / 030284, such markers are produced by mixing a polymer resin with a millable radiopaque material, such as elemental tungsten, and then extruding the composition. In this way, only a low volume fraction of metal can be introduced into the compound, due to the large difference in density between the metal and the polymer. This requires excessively large wall thicknesses to obtain sufficient X-ray contrast. The attachment of the marker to the instrument creates protrusions and changes the profile in an undesirable way. In many cases, external limitations on dimensions do not allow the use of devices with such markings.

[0013] The same applies to the methods of applications DE10020739 and WO2021 / 029348, where wound high-contrast tubes or wires allow better identification of the position and deformation of surgical instruments. The design freedom with regard to the geometrical radiographic patterns that can be produced by these methods is also quite limited here.

[0014] Other methods must be used for ultrasound visualization and marking. These approaches are primarily based on the principle that gaseous materials have a large difference in acoustic impedance compared to solids and human tissues. Taking advantage of the high impedance difference at the gas / solid interface, substrates or coatings are often proposed that contain, for example, gas pockets, voids, pores, gas-containing channels, or fine surface structures to retain surface air inclusions.

[0015] WO98 / 18387 discloses a medical instrument such as a needle, the surface of which is partially covered with a material such as epoxy resin and filled with a reactive substance as a bubble generator. Upon contact with liquid, which may occur during insertion into tissue, the substances such as sodium bicarbonate and citric acid react with the release of gas, generating a large number of mobile gas bubbles. The open pore structure results in a rough surface, which gradually collapses and wets the surface with liquid, so that the desired contrast is obtained in only a short time.

[0016] By embedding hollow spheres, defined cell shapes and highly homogeneous closed pore structures can be realized in synthetic foams. DE 20 2009 001 974 U1 discloses full-surface coatings containing voids, which are produced by embedding hollow microspheres made of vinylidene chloride, some of which can be filled with a gas, such as isobutane.

[0017] Furthermore, catheters are known which are characterized by a multi-layer structure produced by extrusion. Improvements of the individual layers can improve the echogenic properties. EP 1462056 relates to a catheter which consists of at least two layers, the outer layer being thicker than the inner one and in which air bubbles are dispersed. The layers produced in this way have the disadvantage that they are present over the entire length of the extruded part and therefore also in areas where they are rather undesirable. It is not possible to produce patterned markings for better discrimination of the underlying structures and the method-related noise in the ultrasound image. The physical properties of the device are greatly affected. For example, the transparency, which is important for catheters in many cases, is impaired.

[0018] The solution proposed in EP 3 738 543 of realizing the catheter in a multi-layer form and foaming the areas to be marked using laser guidance offers wide possibilities for the graphic design of the echogenic marking, but depends on the special realization of the catheter shaft, which is extruded in a multi-layer form and filled with a laser-absorbing material. It is not possible to apply such echogenic marking to conventional catheter tubes.

[0019] US2014 / 0221828A1 discloses a medical device with a checkerboard echogenic pattern, produced by casting or printing a metal film or by gas-filled plastic construction. In the form shown, the laser treatment recommended for structuring the plastic has the drawback of forming surface irregularities due to ablation and bubble formation. It is known that the material changes caused by the laser beam affect especially the near-surface region and decrease with increasing layer depth. No solution is given as to how to limit the effect of the laser beam to the inside of the catheter wall and how to avoid the formation of surface irregularities.

[0020] The object of the present invention is to create markings on medical devices, in particular catheters, that improve visibility, which can be used in both radiological and ultrasound images, and which can be precisely and easily positioned at any desired site with extremely high geometric variability.

[0021] The instrument remains transparent and is provided with visible markings only in the areas of interest for detectability and possible subsequent manipulation. By designing the markings in the form of graphics, scales and patterns, the detection of instrument displacement, twisting, bending, contraction or expansion and the identification of functional areas are improved.

[0022] Additionally, a method is provided that allows for the creation of simple, echogenic markings on medical devices.

[0023] To this end, the present invention particularly envisages the creation of novel markings by means of polyurethane coatings embedded at high occupation density with particle films having functional properties.

[0024] Using a laser, specific site-selected areas of the coating are dried and chemically crosslinked. The non-irradiated coating material is then washed away, allowing the marking to be realized in any geometric form.

[0025] Particles are selected depending on the desired functionality, for example hollow glass microspheres are used for ultrasound applications and spherical tantalum particles for x-ray visibility.

[0026] By providing an additional particle-free layer as cover (5), optimal particle adhesion and surface smoothness can be achieved.

[0027] For coating, polyurethane systems are preferably used. Polyurethanes are formed by polyaddition of di- or higher-functional alkanols with isocyanates. Polyurethanes are available from various sources and can be applied very efficiently to a variety of substrates, including metals, textiles, ceramics and heat-sensitive plastics. Marking of plastic medical devices is preferred. For this purpose, modular coating systems are commercially available, allowing high flexibility in formulation and application properties. In many cases, polyurethanes also guarantee good biocompatibility, which allows their use for medical purposes.

[0028] Solvent-containing systems or aqueous dispersions and emulsions are used. Aqueous compositions improve biocompatibility and biostability and are more environmentally friendly. The absence of organic solvents often also improves compatibility with the substrate. To speed up the polymerization reaction, catalysts known in polyurethane chemistry can be used. Generally, the amount of catalyst required is very small, on the order of 100 ppm or less. A catalyst-free synthesis is preferred.

[0029] It is particularly preferred to use so-called stoving systems, which undergo a chemical reaction and harden only under increased heat supply. The temperatures are in the range of 100-200°C. The time required for sufficient crosslinking is in the range of 2-100 minutes and can be shortened by increasing the temperature.

[0030] The polyurethane layer is applied to a well-cleaned and optionally activated substrate by conventional methods such as printing, spraying, doctor blading and dipping. As a result of the use of certain dilutions or thickeners, layer thicknesses ranging from 500 nm to several hundreds of μm can be achieved, with 5 to 50 μm being preferred in the context of the present invention.

[0031] Alternatively, other known coatings that can be dried and cured by the action of heat or ultraviolet light and that exhibit biocompatible, non-toxic, hypoallergenic and stable behavior for medical use are also suitable.

[0032] According to the invention, such coatings can also be selected from the group of sol-gel systems, acrylates, melamines, polyesters.

[0033] The adhesion of the functional particles is achieved by utilizing the adhesive properties of the coating material immediately after application. For this purpose, the coated part is sprayed with particles or immersed in a static or fluidized powder so that the particles accumulate as a film on the coating. The definition of a film here is a substantially one-sided monolayer of particles with an average height slightly greater than the average height of the particles.

[0034] For this purpose, it is preferred to use a fluidized bed in which air is fed from below through fine openings, said air stirring up the powder and thus allowing it to circulate freely. At high occupation densities and low layer thicknesses of the particles on the polyurethane layer, a relatively fine and spherical shape proves to be advantageous here.

[0035] The coating structure thus formed is then dried and cured by heat input by a laser. A computer-controlled optical system allows rapidly deflectable laser pulses of the desired power to be directed specifically at the site to be heated. The heat input is precisely defined thermally and geometrically. Due to the programmed movement of the laser beam, relatively large areas of image areas as well as labels, patterns, markings, etc. with small surface areas can be cured with high precision. The marking formed can be in the form of a single piece or can include several parts that can be connected to one another. Circumferential marking is also possible with the aid of a rotating device.

[0036] For this purpose, the use of cost-effective diode-pumped solid-state and fiber lasers in the wavelength range of 1064 nm (NIR), which are used equally for marking and labeling, especially for use on plastic devices, is preferred. The form of marking is programmed with the help of labeling software.

[0037] Furthermore, the use of excimer lasers, for example by masking techniques, is also possible. However, other conventional laser types, such as CO2 lasers and other dye lasers, with wavelengths in the region of high absorption by the absorber material used, can also achieve the desired results. The power of the laser used and the settings of the various laser parameters depend on the specific application and can be easily determined by the skilled person in each case.

[0038] In the case of metallic instruments, the laser energy is absorbed by the substrate, so that the coating material is heated indirectly. However, unfilled catheter plastics such as TPU, PVC and silicone, as well as the polyurethane coating itself, are laser-transparent at wavelengths from near-ultraviolet to near-infrared light, i.e. they do not show any interaction with the laser radiation. It has been found that metal particles, which are actually applied to the coating for the purpose of X-ray contrast, also result in very good laser absorption and therefore heat input into the coating. The adhesive metal particles allow the polyurethane reaction mixture to be cured by laser treatment without the addition of laser additives, even for laser-transparent heat-sensitive materials. Due to the specific heat transfer from the solid particles to the polyurethane layer, a very strong adhesion of the particles at the contact site is achieved. The required reaction time is ensured by repeatedly directing the laser beam over the entire treatment area.

[0039] The non-irradiated and therefore non-crosslinked coating material is washed away, making the marking practically available. The rinsing liquid is selected according to the applied coating system and the substrate. In the case of aqueous composites, water is preferably used for rinsing. If organic solvents are required, their attack on the substrate and the crosslinked coating material must be precluded. Suitable solvents can be ketones, such as acetone, butanone, methyl ethyl ketone and methyl isobutyl ketone, cyclic or aromatic hydrocarbons, such as xylene, toluene and cyclohexane, or esters, such as butyl acetate, ethyl acetate and methoxypropyl acetate, or mixtures of the aforementioned substances.

[0040] By applying an additional polyurethane layer, conventionally or by laser treatment, the particle adhesion can be further improved and the surface roughness reduced. This also achieves insulation between the metal particles and the instrument, preventing undesirable electrochemical processes in blood or other body fluids. Furthermore, it has also been found to be advantageous to subject the medical device with the applied marking to a temperature treatment in a heat cabinet, which ensures that the polyurethane coating has fully reacted and that the solvent has fully evaporated.

[0041] The necessary functionality of the marking according to the invention is ensured by the embedded particles. Radiopaque powder materials suitable for imaging in radiodiagnosis include metallic materials with high atomic numbers such as platinum, tantalum, iridium, tungsten, rhenium, gold and alloys of these metals. Metallic compounds such as tungsten carbide, tungsten boride, barium sulfate and bismuth oxychloride may also be used to mark metal instruments.

[0042] The shape of the particles is not critical, but they should preferably be spherical. Suitable particle sizes are in the range of 1-50 μm, with diameters of 5-10 μm being particularly preferred. The smaller the particles, the thinner the coating and the less likely they are to impair the properties of the medical device. In the case of non-spherical particles, the sizes given relate to the equivalent spherical diameter, i.e. the diameter of a sphere having the same volume as the particle.

[0043] One of the main advantages of the method according to the invention is that the particles are embedded at a very high rate in the total volume of the coating: functional volume fractions are achieved in the range of 40-75%, preferably 50-70%.

[0044] According to the prior art, hollow microspheres can be embedded in the marking composite for the function of ultrasound visualization. Particularly suitable are hollow glass and ceramic spheres, as well as polymeric microspheres.

[0045] Alternatively, expandable microspheres are used. These particles are microscopically small spheres with a thermoplastic outer shell and a filling material consisting of condensed gases that expand when heated. Besides the use of already expanded hollow spheres, there is also the possibility of expanding the non-expanded types as part of a laser treatment. In this way, the proportion of functional volume in the coating can be further increased.

[0046] Compared with rigid hollow spheres, polymeric elastic microbubbles can improve ultrasound visibility because they not only offer an acoustic impedance significantly different from that of human tissue, but also act as ultrasonic resonators, enhancing the backscattering effect.

[0047] Preferably, echogenic microparticles with a diameter of 1 to 50 μm are used.

[0048] However, the laser absorption of hollow microbodies is very low, so their use in the context of the method according to the invention is limited to devices containing metallic materials. Surprisingly, it has been found that coating structures with embedded metallic particles also result in very good echogenic behavior. In this method, it must be assumed that voids will occur in the coating composite that are not completely filled with polymer even when the final top layer is applied. The second polyurethane layer has a closed pore structure, so that the voids are preserved even when in contact with body fluids and other liquids. Gas inclusions in the coating cause strong reflection of sound waves, which are then imaged brighter in ultrasound images compared to the surrounding material.

[0049] This method makes it possible to produce markings on metallic and non-metallic instruments, improving imaging by both radiological and ultrasound diagnostic methods. Studies on the cited examples show that, despite the dual-function effect of the marking, both methods achieve high image quality with perfect contrast and a high level of detail. The marking is distinguished by high wipe- and scratch-resistance and is stable even during subsequent sterilization processes.

[0050] The claimed method is therefore particularly suitable for marking catheters, where previously only few technical solutions were available to improve detectability. The preferred patterning of the marking allows easy discrimination from underlying structures, and displacements, bends or kinks can be easily detected. Furthermore, there is also the option to scale areas of particular interest by the pattern and highlight them for subsequent catheter manipulation.

[0051] Besides use with catheters, the method may also be applied to other medical devices inserted or implanted in the animal or human body. Thus, the medical device according to the present invention is preferably selected from the group consisting of catheters, needles, stents, cannulas, tracheotomes, endoscopes, dilators, tubes, introducers, markers, stylets, snares, angioplasty instruments, fiducial markers, trocars and forceps.

[0052] The invention will now be described on the basis of illustrative embodiments, further details, advantages and features of the invention will become readily apparent from the claims. [Brief description of the drawings]

[0053] [Figure 1] FIG. 1 is a schematic diagram of markings on a catheter made according to Example 1. [Diagram 2] FIG. 2 is a photograph of a catheter provided with markings according to Example 1. [Diagram 3] Figure 3 Ultrasound images of markings made according to Examples 1 and 2. (a) Measurements on a catheter and in water. (b) Measurements on a cannula and on an ultrasound phantom. [Figure 4] FIG. 4: X-ray of a catheter manufactured according to Example 1.

[0054] Figure 1 shows different views of the principle structure of a catheter 01 with markings 03, 04. By way of example, the catheter is embodied with three annular markings 03 arranged circumferentially with different widths and three markings connecting the rings as bridges 04 arranged longitudinally.

[0055] The marking is located on the catheter wall 02 and is characterized by a structure in which a membrane of densely packed metal particles 07 is embedded between two polyurethane layers 05, 06. The space between the particles is not completely filled with polymer, which means the presence of a void 08 containing air. This void is closed on the outside by the top layer 06. The radiopaque spherical metal particles 07 have an average size of 10 μm and occupy 50-70% of the volume of the marking. The total thickness of the coating is about 15 μm, which is slightly more than the diameter of the individual particles.

[0056] The markings shown in FIG. 12 were provided on a TPU catheter having an outer diameter of 3 mm and a structure according to FIG.

[0057] The markings made according to the invention stand out with very high brightness contrast and good contour definition against a black background and against untreated areas of the instrument in X-rays (FIG. 3) and ultrasound images (FIG. 4).

[0058] The invention is illustrated by the following examples, in which percentages are understood to mean % by weight, unless otherwise indicated or clear from the context.

[0059] Materials used Unless otherwise stated, all materials were purchased from CSC JAKLECHEMIE GmbH & Co. KG.

[0060] Elastollan® 1180 A10 FC is a TPU from BASF with a Shore A hardness of 80, a strength of 45 MPa, and an elongation at break of 650%.

[0061] Desmophen® T1777 is a polyol component for the production of polyurethane stove coatings using a blocked aliphatic polyisocyanate from Covestro.

[0062] Desmodur® BL 3475 is a diethyl malonate blocked aliphatic polyisocyanate based on isophorone diisocyanate (IPDI) and hexamethylene diisocyanate (HDI) from Covestro.

[0063] Bayhytherm® 3246 is a water-dilutable, aliphatic, self-crosslinking stover urethane resin from Covestro.

[0064] method Ultrasound visibility tests were performed using a Mindray DP-50 ultrasound diagnostic device with a linear sonic head in B-mode at an acoustic frequency of 8 MHz. Ultrasound images were taken both in a water bath and in an ultrasound phantom with tissue-like properties, with the various devices positioned at 45° to the sound direction. To assess the contrast of the markings relative to unmarked areas, image processing software was used to average the grayscale spectra (histograms) of the individual areas of the ultrasound images and compare them with each other, with 100% black corresponding to a value of 0 and 100% white corresponding to a value of 255.

[0065] The X-ray images were examined with an intraoral radiography system from Trophy-Radiologie GmbH using digital sensor technology. As a comparison standard, the measurements included aluminum strips with graded thicknesses of 1, 2, 3 and 4 mm. The exposure settings of the radiography device were selected such that four levels were captured with high contrast difference (70 kV, 10 mA, 0.5 sec, sensor size 18 x 24 cm).

[0066] Example 1 This example illustrates the production of a marking according to the invention on a catheter.

[0067] A tube extrusion system is used to manufacture catheters with an outer diameter of 3 mm and a layer thickness of 0.5 mm. The tube material is Elastollan® 1180 A10 FC type TPU.

[0068] The coating material is prepared by adding the following ingredients to a beaker and mixing: Desmophen® T1777: 34.8% Desmodur® BL 3475: 27.9% 1-Methoxy-2-propyl acetate: 37.2%

[0069] One end of the catheter is closed with a stopper, immersed in the coating solution, and then very slowly withdrawn at a speed of 1 mm / sec. Excess solution is allowed to drip off and the coated tube is allowed to dry at room temperature for 2 minutes.

[0070] In the fluidized bed, tantalum powder with an average particle size of 8 μm is wound up by compressed air. The catheter is immersed in the fluidized bed while rotating and left there until enough particles are attached to the adhesive coating. After a further 10 minutes of drying, the tube is irradiated with a pulsed 10 watt Yb fiber laser from FOBA. By choosing the appropriate laser parameters (laser power: 20%, traverse speed: 10 mm / s, pulse frequency: 20 kHz), the temperature increases near the irradiation sites 03, 04, leading to crosslinking and hardening of the coating. The movement of the laser beam to define the contour and fill the area is repeated multiple times such that the local temperature increase is maintained for 20 minutes.

[0071] Circumferential ring markings 03 were programmed as rectangles in the laser labeling software and were achieved by axial rotation of the tube during laser processing. Bridges 04 were formed on the stationary tube by repeating the laser strokes every 120° of the tube rotation. After completion of the laser treatment, the coated portion of the catheter was immersed in 1-methoxy-2-propyl acetate and the uncured coating material was washed away by agitation.

[0072] After a drying time of 10 minutes, the top layer is formed by repeating the procedure of dip coating, laser treatment and rinsing. The application of particles is omitted in this step. The result is the marking shown in Figure 2.

[0073] Figure 3a shows an ultrasound image of catheter 01 immersed in water at 45° to the transmitted ultrasound. A radiographic image of the marked catheter can be seen in Figure 4. Standards (aluminium plates of graduated thicknesses of 1, 2, 3 and 4 mm) were included in this image to allow comparison with the conventional method.

[0074] The table below gives an overview of the average luminance of various image regions as determined from the greyscale histogram.

[0075] [Table 1]

[0076] The high level of functionality of the image marking is demonstrated both by subjective visual inspection and by digital analysis of the images. The marking has extremely good radiopacity, equivalent to an aluminum plate approximately 2 mm thick.

[0077] Example 2 In this example, the formation of markings according to the present invention on a 22G disposable cannula (outer diameter: 0.7 mm) made of stainless chromium-nickel steel is described.

[0078] In contrast to Example 1, the coating material is prepared from the following ingredients: Bayhytherm® 3246: 90% Distilled water: 10%

[0079] The particles used are hollow glass microspheres of the 3M™ Glass Bubbles K37 type with an average particle size of 40 μm. The marking is in the form of three circumferential rings 3 mm wide.

[0080] Ultrasound testing was performed in a commercially available ultrasound phantom of tissue-mimicking material. Figure 3b shows an ultrasound image of a 0.7 mm thin needle at a depth of 1–2 cm and an ultrasound frequency of 8 MHz.

[0081] The table below gives an overview of the mean brightness of different image regions in the ultrasound image as calculated from the greyscale histogram (Figure 3b).

[0082] Despite the small diameter of the needle, the markings are distinguished by very good ultrasound visibility.

[0083] [Table 2] [Explanation of symbols]

[0084] 01 Catheter 02 Catheter wall 03 Ring marking 04 Bridge marking 05 PU base layer 06 PU upper layer 07 Particle film

Claims

1. 1. A method of manufacturing a medical device having markings visible for imaging, comprising: a. applying a thin layer of a liquid thermosetting polyurethane system to the device on which the marking is to be applied; b. depositing a film of hollow microspheres or metal particles onto the polyurethane coating applied in step a); c. curing the coating material in defined areas with a patterned laser such that only a portion of the coating material is cured; d. Washing away any uncrosslinked coating material with a suitable solvent; and e. Applying and curing the top layer The method comprising:

2. The method of claim 1, wherein the metal particles have a size of 1 to 50 μm, preferably 1 to 10 μm.

3. The metal particles are 4 g / cm ３ 3. The method according to claim 1 or 2, characterized in that the metals have a higher density and an atomic number greater than 21, preferably platinum, tantalum, iridium, tungsten, rhenium, gold and alloys of these metals, but also suitable are metal compounds such as tungsten carbide, tungsten boride, barium sulfate and bismuth oxychloride.

4. The method of claim 1, wherein the hollow microspheres have a particle size of 10 to 80 μm, preferably 30 to 50 μm.

5. 10. The method of claim 1, wherein the hollow microspheres are used in the form of hollow glass and ceramic spheres and in the form of polymeric microspheres.

6. 2. The method of claim 1, wherein the volume fraction of particles in the coating is 40-75%, preferably 50-70%.

7. The method of claim 1 , wherein the marking may be in the form of a symbol, shape, graphic, scale, or pattern.

8. 10. The method of claim 1, wherein the particle film is applied by immersion in a fluidized bath containing fluidized powder, or by spraying or doctor blading.

9. 2. The method of claim 1, wherein the curing of the coating is carried out by irradiation with laser light having a wavelength in the near ultraviolet and / or visible and / or near infrared range.

10. 10. A medical device having markings for imaging manufactured by the method of claim 1.

11. 11. The medical device of claim 10, wherein the device comprises a catheter, a needle, a stent, a cannula, a tracheotomy, an endoscope, a dilator, a tube, an introducer, a marker, a stylet, a snare, an angioplasty instrument, a trocar, and a forceps.

Images