Ni-ti alloy stent and its expanding method

Abstract

The present application belongs to the technical field of medical stent production, and particularly relates to a nitinol stent and a diameter expansion method thereof. The diameter expansion method of the nitinol stent of the present application realizes the coupling of temperature gradient and strain gradient through the gradient process of alternating low-temperature aging treatment and high-temperature aging treatment and matching single large deformation expansion, can obtain the composite strengthening effect of grain refinement, dislocation strengthening and precipitation strengthening, and at the same time, avoids the defects such as grain boundary hot corrosion caused by multiple small deformation expansion and hydrogen embrittlement caused by multiple high-temperature exposure, greatly improves the radial support force and chronic abduction force of the nitinol stent, maintains excellent low-energy dissipation super-elasticity characteristics, can eliminate defective raw materials in the early production stage through overload effect, effectively improves the production efficiency and reduces the production cost, improves the comprehensive mechanical properties and yield of the stent product, and is suitable for the industrialized production of large-size nitinol vascular stents.

Description

Technical Field

[0001] This invention belongs to the field of medical stent manufacturing technology, specifically relating to a nickel-titanium stent and its diameter expansion method. Background Technology

[0002] Nickel-titanium alloys are widely used in the manufacture of implantable devices such as endovascular stents and heart valve stents due to their superelasticity (stress-induced martensitic transformation) and shape memory effect. When in use in the body, stents need to provide support to the lesion area while withstanding hundreds of millions of cyclic pulsating loads generated by heartbeats or limb movements. Therefore, support force and fatigue performance are the core performance indicators of stent products.

[0003] Current manufacturing processes for NiTiNo stents typically include: laser cutting of the tubing → single-temperature (approximately 500℃) heat treatment for shaping followed by multiple small-deformation diameter expansions → sandblasting / acid pickling to remove oxide scale → electropolishing. This process has the following problems: 1. Abnormal grain growth problem. Traditional high-temperature aging heat treatment temperatures are higher than the recrystallization temperature of nickel-titanium alloys. If the temperature control is uneven or the holding time is too long, it can easily lead to abnormal growth of local grains to tens or even hundreds of micrometers. According to the principles of materials science, under cyclic strain, large grain structures have a significantly reduced resistance to fatigue crack initiation due to rapid dislocation accumulation and increased residual martensite.

[0004] 2. Dislocation configuration instability. Single-temperature setting process cannot directionally control the dislocation configuration. The low and uneven distribution of dislocation density leads to a wide stress-strain hysteresis loop, large cumulative damage, and high fatigue life dispersion under cyclic loading.

[0005] 3. Surface hot corrosion problem. The traditional high-temperature aging heat treatment temperature is higher than the isobaric temperature of nickel-titanium alloy. Repeated exposure to high temperatures in the furnace makes the surface of the support prone to hot corrosion pits, forming micro-stress concentration sources and accelerating the initiation of fatigue cracks.

[0006] 4. Process efficiency and hydrogen embrittlement risk. To control the stress during each expansion and prevent fracture, conventional processes typically involve more than 10 small-deformation expansions, requiring multiple passes through the heat treatment furnace. This not only results in low production efficiency but also increases the hydrogen absorption of the support structure due to repeated high-temperature exposure, posing a risk of hydrogen-induced delayed fracture (hydrogen embrittlement).

[0007] 5. Insufficient screening of raw material defects. The stress level of conventional small deformation expansion is low. Even if there are non-metallic inclusions with sizes close to the critical value inside the pipe, they may pass the expansion process and the problem will not be exposed until the fatigue test or clinical use of the finished product.

[0008] Therefore, there is an urgent need for a new thermomechanical treatment method that can simultaneously achieve grain refinement, dislocation configuration stabilization, surface quality control, production efficiency improvement, and early defect screening. Summary of the Invention

[0009] The purpose of this invention is to provide a nickel-titanium stent and a method for expanding its diameter.

[0010] This application provides a method for expanding the diameter of a nickel-titanium stent, including: Perform steps a, b, and c several times until the inner diameter of the stent reaches the preset target value; whereby... The first execution is either step a or step c, and steps a and c are executed alternately, with step b executed between steps a and c; wherein... Step a is low-temperature aging treatment: Place the mold with the support bracket in the heat treatment furnace, heat it to the low-temperature aging zone, and hold it for a preset time; Step b is the low-temperature assisted tooling replacement: After the heat-treated bracket is cooled to room temperature along with the mold, it is placed in a low-temperature medium below the martensitic transformation start temperature of the material. In this low-temperature medium, the bracket is transferred and clamped from the current shaping mold to the next larger diameter shaping mold. Step c is high-temperature aging treatment: the mold with the bracket is placed in the heat treatment furnace, heated to the high-temperature aging zone, and held for a preset time.

[0011] In one embodiment of this application, the temperature of the low-temperature aging zone is 250°C to 350°C; and the temperature of the high-temperature aging zone is 450°C to 550°C.

[0012] In one embodiment of this application, before each execution of step a, the actual strain of a single stent expansion is measured to be more than 25%; before each execution of step c, the actual strain of a single stent expansion is measured to be more than 45%. In the above formula, D is the outer diameter of the mold used in this expansion, and ID0 is the inner diameter of the support before this expansion.

[0013] In one embodiment of this application, the actual strain of a single stent expansion before step c is at least 1 times the actual strain of a single stent expansion before the previous step a.

[0014] In one embodiment of this application, the heat preservation time in step c is more than 1.5 times that in step a.

[0015] In one embodiment of this application, the preset target value of the outer diameter of the stent is more than 150% of the original outer diameter of the stent.

[0016] In one embodiment of this application, the cryogenic medium includes one of an ice-alcohol bath, an ice-salt bath, a dry ice-solvent bath, or a liquid nitrogen-solvent bath; The temperature range of the cryogenic medium is -50℃ to -10℃.

[0017] In one embodiment of this application, after each step a or step c is performed, the oxide film morphology is inspected at the stress concentration node of the bracket bend, and defective products with microcracks are removed.

[0018] In one embodiment of this application, a final shaping heat treatment step is performed after the inner diameter of the support reaches a preset target value, which includes: The support was mounted onto the final molding die in a cryogenic medium. Keep warm at 480–530℃ for 8–30 minutes, cool to room temperature, remove the bracket, and obtain the final product.

[0019] Accordingly, this application provides a nickel-titanium stent, which is processed using the diameter expansion method described above.

[0020] The beneficial effects of this invention are: The diameter expansion method of the nitinol stent of the present invention achieves the coupling effect of temperature gradient and strain gradient by alternating low-temperature aging treatment and high-temperature aging treatment, combined with a single large deformation expansion gradient process. This can achieve a composite strengthening effect of grain refinement, dislocation strengthening and precipitation strengthening, while avoiding defects such as grain boundary hot corrosion and hydrogen embrittlement caused by repeated small deformation expansion. While significantly improving the radial support force and chronic outward force of the nitinol stent, it maintains excellent low energy dissipation superelasticity. It can also eliminate defective raw materials in the early stage of production through overload effect, effectively improving production efficiency, reducing production costs, and improving the comprehensive mechanical properties and yield of the finished stent. It is suitable for the industrial production of large-size nitinol vascular stents.

[0021] Other features and advantages of the invention will be set forth in the following description, and will be apparent in part from the description, or may be learned by practicing the invention. The objects and other advantages of the invention are realized and obtained through the structures particularly pointed out in the description and the drawings.

[0022] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0023] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0024] Figure 1 This is a schematic flowchart of a method for expanding the diameter of a nickel-titanium stent according to an embodiment of the present invention; Figure 2 This is a comparison diagram of radial force tests of NiTiNCO stents in Embodiment 1 of the present invention and various comparative examples; Figure 3 This is a comparison diagram of the radial force test of the nickel-titanium stent in Embodiment 1 and Embodiment 2 of the present invention; Figure 4 This is a set of schematic diagrams illustrating the assembly of the bracket and mold according to an embodiment of the present invention. Detailed Implementation

[0025] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0026] One embodiment of this application provides a method for expanding the diameter of a nickel-titanium stent, including: Perform steps a, b, and c several times until the inner diameter of the stent reaches the preset target value; whereby... The first execution is either step a or step c, and steps a and c are executed alternately, with step b executed between steps a and c; wherein... Step a is low-temperature aging treatment: Place the mold with the support bracket in the heat treatment furnace, heat it to the low-temperature aging zone, and hold it for a preset time; Step b is the low-temperature assisted tooling replacement: After the heat-treated bracket is cooled to room temperature along with the mold, it is placed in a low-temperature medium below the martensitic transformation start temperature of the material. In this low-temperature medium, the bracket is transferred and clamped from the current shaping mold to the next larger diameter shaping mold. Step c is high-temperature aging treatment: the mold with the bracket is placed in the heat treatment furnace, heated to the high-temperature aging zone, and held for a preset time.

[0027] It is understandable that the first diameter expansion aging treatment can be either the low-temperature aging treatment of step a or the high-temperature aging treatment of step c; steps a and c are performed alternately until the outer diameter of the support reaches the preset target value. During this process, if the mold needs to be replaced after each aging treatment, step b is executed, where the mold is replaced and installed in a low-temperature medium, and then the next aging treatment is performed. In other words, step b needs to be executed between steps a and c. For example, the diameter expansion steps could be in the sequence of "abc", "cba", "abcba-...", "cbabcba-...", etc.

[0028] In one embodiment of this application, the temperature of the low-temperature aging zone is 250°C to 350°C.

[0029] In one embodiment of this application, the temperature of the high-temperature aging zone is 450°C to 550°C.

[0030] In one embodiment of this application, before each execution of step a, the actual strain of a single stent expansion is measured to be more than 25%; Before each execution of step c, the actual strain of a single stent expansion was measured to be above 45%; In the above formula, D is the outer diameter of the mold used in this expansion, and ID0 is the inner diameter of the support before this expansion.

[0031] In one embodiment of this application, the actual strain of a single stent expansion before step c is at least 1 times the actual strain of a single stent expansion before the previous step a.

[0032] In one embodiment of this application, the heat preservation time in step c is more than 1.5 times that in step a.

[0033] In one embodiment of this application, the preset target value of the outer diameter of the stent is more than 150% of the original outer diameter of the stent.

[0034] In one embodiment of this application, the cryogenic medium includes one of an ice-alcohol bath, an ice-salt bath, a dry ice-solvent bath, or a liquid nitrogen-solvent bath.

[0035] In one embodiment of this application, the temperature range of the cryogenic medium is -50°C to -10°C.

[0036] In one embodiment of this application, after each step a or step c is performed, the oxide film morphology is inspected at the stress concentration node of the bracket bend, and defective products with microcracks are removed.

[0037] In one embodiment of this application, a final shaping heat treatment step is performed after the inner diameter of the support reaches a preset target value, which includes: The support was mounted onto the final molding die in a cryogenic medium. Keep warm at 480–530℃ for 8–30 minutes, cool to room temperature, remove the bracket, and obtain the final product.

[0038] Accordingly, this application provides a nickel-titanium stent, which is processed using the diameter expansion method described above.

[0039] In all the following examples and comparative examples, the raw material used was nickel-55.9wt% nickel-rich titanium alloy tubing with an outer diameter of 1.585mm to 1.615mm and an inner diameter of 1.285mm to 1.315mm. The initial austenitic phase transformation completion temperature was 2℃. The tubing was processed into support parts using a femtosecond laser cutting machine, followed by the heat treatment as in the examples and comparative examples. The original inner diameter of the support was 1.285mm to 1.315mm. The heat treatment equipment was a Nabertherm air-circulating furnace, specification N60 / 85HA. Water quenching was performed using pure water at 15-25℃ to cool the aged support to room temperature. The ice-alcohol bath temperature was -25℃. The mold used was a stainless steel mandrel.

[0040] Example 1

[0041] The original inner diameter of the stent is 1.285mm to 1.315mm. Starting from an inner diameter of 4mm, it is gradually expanded to the preset value of 16mm in increments of 4mm each time.

[0042] The support is heat-treated according to the steps “abcbac”. In step a, the holding time is 5 minutes and the aging temperature is 300℃; in step c, the holding time is 10 minutes and the aging temperature is 520℃.

[0043] Finally, the support is fitted into the 18mm final shaping mandrel and held at 520℃ for 20 minutes (to adjust the austenitic phase transformation end temperature of the product to the factory requirements). After water quenching, the support is removed to obtain the final product.

[0044] Example 2

[0045] The original inner diameter of the stent is 1.285mm to 1.315mm. Starting from an inner diameter of 4mm, it is gradually expanded to the preset value of 16mm in increments of 4mm each time.

[0046] The support is heat-treated according to the steps “cbabcba”. Specifically, the holding time in step c is 10 minutes and the aging temperature is 520℃; the holding time in step a is 5 minutes and the aging temperature is 300℃.

[0047] Finally, the support is fitted into the 18mm final shaping mandrel and held at 520℃ for 20 minutes (to adjust the austenitic phase transformation end temperature of the product to the factory requirements). After water quenching, the support is removed to obtain the final product.

[0048] Comparative Example 1 The original inner diameter of the stent is 1.285mm to 1.315mm. Starting from an inner diameter of 2mm, it is gradually expanded to the preset value of 16mm in increments of 2mm using a traditional expansion process.

[0049] For each expansion step, the support is fitted with a stainless steel mandrel of the corresponding diameter and placed in a 500℃ air-circulating furnace for heat preservation and aging treatment. After removal, it is quickly water-quenched to room temperature and replaced with the next stage mandrel. The support is subjected to the above operation repeatedly with mandrels of 2mm, 4mm, 6mm, 8mm, 10mm, 12mm, 14mm, and 16mm in sequence, completing a total of 8 steps of expansion and shaping. The heat preservation time for steps 1 to 5 is 5 minutes, for steps 6 to 7 it is 8 minutes, and for step 8 it is 10 minutes.

[0050] Finally, the bracket is fitted into the 18mm final shaping mandrel, kept at 500℃ for 23 minutes, water quenched, and the bracket is removed to obtain the final product.

[0051] Comparative Example 2: The original inner diameter of the stent was 1.285mm to 1.315mm. Starting from an inner diameter of 2mm, it was gradually expanded to the preset value of 16mm in increments of 2mm. Comparative Example 2 improved upon Comparative Example 1 only by alternating high and low temperature aging.

[0052] For each expansion step, the support was fitted with a stainless steel mandrel of the corresponding diameter and placed in an air-circulating furnace for heat preservation and aging treatment. After removal, it was quickly water-quenched to room temperature and replaced with the next mandrel. The support was subjected to the above operation repeatedly with mandrels of 2mm, 4mm, 6mm, 8mm, 10mm, 12mm, 14mm, and 16mm in sequence, completing a total of 8 step-by-step expansion and shaping. The heat preservation time for steps 1-5 was 5 minutes, for steps 6-7 it was 8 minutes, and for step 8 it was 10 minutes. To verify the effect of individual gradient aging on the product performance, the aging temperature for steps 1, 3, 5, and 7 in Comparative Example 2 was 500℃, and the aging temperature for steps 2, 4, and 6 was 300℃.

[0053] Finally, the bracket is fitted into the 18mm final shaping mandrel, kept at 500℃ for 23 minutes, water quenched, and the bracket is removed to obtain the final product.

[0054] Comparative Example 3: The original inner diameter of the stent was 1.285mm to 1.315mm. Starting from an inner diameter of 4mm, it was gradually expanded to the preset value of 16mm in increments of 4mm. Comparative Example 3 improved upon Comparative Example 1 only in terms of the single expansion value.

[0055] The support is heat-treated according to the steps “abcbac”. Specifically, steps a and c involve aging at 500℃ for 10 minutes each.

[0056] Finally, the bracket is fitted into the 18mm final shaping mandrel, kept at 500℃ for 20 minutes, water quenched, and the bracket is removed to obtain the final product.

[0057] Performance Testing and Comparative Analysis Radial support force, chronic expansion force, and hysteresis loop area were measured for each embodiment and comparative example, and the production time was recorded. Radial force was measured using a LOCKWISE radial force tester. The support was compressed from an outer diameter of 20 mm to 12 mm at 37 degrees Celsius and then released, with a compression and release rate of 0.2 mm / s. This compression-release cycle was repeated three times to obtain a stable radial force curve. The force value at 14 mm compression was recorded as the radial support force, and the force value at 14 mm expansion was recorded as the chronic expansion force. The hysteresis loop area refers to the area enclosed by the closed loop formed by the stress-strain curve when the support is subjected to cyclic loads (such as repeated tension, compression, or bending). See [link to relevant documentation]. Figure 2 The test results are shown in the table below.

[0058] As shown in the table above, compared with Comparative Example 1, Example 1 shows a significant improvement of over 10% in radial support force and chronic outward force while maintaining a hysteresis loop area almost identical to the original process. The product as a whole exhibits superior radial strength and a reliable phase transition path. The radial support force, chronic outward hysteresis loop area, and other indicators of the products obtained in Example 1 and Example 2 are highly similar. This indicates that regardless of whether a high-temperature aging followed by a low-temperature aging process or a low-temperature aging followed by a high-temperature aging process is used, the expected technical effects of this invention can be stably achieved, demonstrating the robustness and flexibility of this invention.

[0059] Compared to Comparative Example 1, Comparative Example 2 showed only a slight increase in radial support force and chronic outward force, but a significant increase in the hysteresis loop area from 3.59 to 4.35. The hysteresis loop area is a key indicator of energy dissipation during hyperelastic cycling. An increased area signifies increased irreversible energy loss during the martensitic phase transformation, predicting a potential decrease in fatigue life and possible damage to the vessel wall due to phase transformation exothermics. This indicates that, without pre-strain constraints, the new temperature regime cannot guide the preferential distribution of beneficial precipitates; instead, it leads to increased frictional losses between martensitic variants. Compared to Comparative Example 1, Comparative Example 3 showed the same radial support force as the original process, but the chronic outward force decreased from 2.95 to 2.80, and the hysteresis loop area further deteriorated to 4.65. Meanwhile, although the production time was shortened to 60 minutes, this came at the cost of sacrificing mechanical stability. This indicates that under the high-temperature multiple aging regime of the original process, the microstructure optimization brought about by pre-strain was partially offset by the recovery and recrystallization induced by high temperature, instead introducing unfavorable internal friction.

[0060] Furthermore, the core performance indicators of Comparative Examples 2 and 3 failed to surpass, and were even inferior to, Comparative Example 1. Based on this "useless or even harmful" performance of a single factor, it can be proven that the present invention is a coupled process of gradient aging temperature and large diameter expansion deformation, rather than a simple superposition of multiple factors.

[0061] Therefore, compared with the prior art, the present invention has the following beneficial effects: 1. Significant improvement in support performance. The radial support force reached 4.36 N, an increase of 13.2%, 10.4%, and 12.7% compared to the three comparative examples, respectively; the chronic outward force reached 3.41 N, an increase of 15.6% compared to comparative example 1. The magnitude of the enhancement exceeds the slight improvement of comparative example 2, proving that the coupling process of gradient aging and diameter expansion in this invention is not a simple superposition of multiple factors.

[0062] 2. Superior Superelasticity and Fatigue Potential. The hysteresis loop area in the embodiment is only 3.65, which is basically equivalent to 3.59 in Comparative Example 1 but much smaller than 4.35 in Comparative Example 2 and 4.65 in Comparative Example 3. This means that the process of the present invention effectively improves the support stiffness while maintaining excellent superelastic recovery capability and low energy dissipation, providing a physical basis for stable fatigue life.

[0063] 3. Overload screening effect. The single large strain expansion exceeding 25% in the gradient strengthening aging diameter expansion step creates an overload screening effect on the raw material pipe. If non-metallic inclusions exceeding the critical size exist inside the pipe, they will directly fracture under this large strain condition. This allows for the timely detection and removal of defective raw materials in the early stages of manufacturing, preventing them from flowing into subsequent processes and causing greater waste of energy and time.

[0064] 4. Improved Process Efficiency and Mitigation of Hydrogen Embrittlement Risk. This invention reduces the total number of diameter expansion cycles to 3-5 by setting a single large strain variable, improving efficiency by more than 30% compared to the conventional 10+ cycles. Correspondingly, the number of furnace feeds in the heat treatment process is also reduced, significantly improving production efficiency while lowering the risk of hydrogen embrittlement caused by repeated high-temperature exposure.

[0065] 5. A significant reduction in hot corrosion pits at support nodes. For large-size supports, the original process involved multiple long-term high-temperature aging processes exceeding the "equal strength temperature" of nickel-titanium materials. Since grain boundary strength is much more sensitive to deformation rate than grain strength, approximately 30% of products exhibit hot corrosion pits at nodes with significant deformation. Products using the process of this invention, however, show no hot corrosion defects due to the shorter holding time in the high-temperature aging zone.

[0066] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A method for expanding the diameter of a nickel-titanium stent, characterized in that, include: Perform steps a, b, and c several times until the inner diameter of the stent reaches the preset target value. in The first execution is either step a or step c, and steps a and c are executed alternately, with step b executed between steps a and c; in Step a is low-temperature aging treatment: Place the mold with the support bracket in the heat treatment furnace, heat it to the low-temperature aging zone, and hold it for a preset time; Step b is the low-temperature assisted tooling replacement: After the heat-treated bracket is cooled to room temperature along with the mold, it is placed in a low-temperature medium below the martensitic transformation start temperature of the material. In this low-temperature medium, the bracket is transferred and clamped from the current shaping mold to the next larger diameter shaping mold. Step c is high-temperature aging treatment: the mold with the bracket is placed in the heat treatment furnace, heated to the high-temperature aging zone, and held for a preset time.

2. The method for expanding the diameter of a nickel-titanium stent according to claim 1, characterized in that, The temperature of the low-temperature aging zone is 250℃~350℃; The temperature of the high-temperature aging zone is 450℃~550℃.

3. The method for expanding the diameter of a nickel-titanium stent according to claim 1, characterized in that, Before each execution of step a, the actual strain of a single stent expansion was measured to be above 25%; Before each execution of step c, the actual strain of a single stent expansion was measured to be above 45%; In the above formula, D is the outer diameter of the mold used in this expansion, and ID0 is the inner diameter of the support before this expansion.

4. The method for expanding the diameter of a nickel-titanium stent according to claim 1, characterized in that, The true strain of a single stent expansion before step c is at least 1 times the true strain of a single stent expansion before the previous step a.

5. The method for expanding the diameter of a nickel-titanium stent according to claim 1, characterized in that, The heat preservation time in step c is more than 1.5 times that in step a.

6. The method for expanding the diameter of a nickel-titanium stent according to claim 1, characterized in that, The preset target value for the outer diameter of the support is more than 150% of the original outer diameter of the support.

7. The method for expanding the diameter of a nickel-titanium stent according to claim 1, characterized in that, The cryogenic medium includes one of the following: an ice-alcohol bath, an ice-salt bath, a dry ice-solvent bath, or a liquid nitrogen-solvent bath; The temperature range of the cryogenic medium is -50℃ to -10℃.

8. The method for expanding the diameter of a nickel-titanium stent according to claim 1, characterized in that, After each step a or step c is completed, the oxide film morphology is inspected at the stress concentration nodes of the support bend, and defective products with microcracks are removed.

9. The method for expanding the diameter of a nickel-titanium stent according to claim 1, characterized in that, After the inner diameter of the support reaches the preset target value, a final shaping heat treatment step is performed, which includes: The support was mounted onto the final molding die in a cryogenic medium. Keep warm at 480–530℃ for 8–30 minutes, cool to room temperature, remove the bracket, and obtain the final product.

10. A nickel-titanium stent, characterized in that, The process is carried out using the diameter expansion method as described in any one of claims 1-9.

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